Vineet Chopra, MD, MSc

Peripherally inserted central catheters (PICCs) are integral to the care of hospitalized patients in the United States.¹ Consequently, utilization of these devices in acutely ill patients has steadily increased in the past decade.² Although originally designed to support the delivery of total parenteral nutrition, PICCs have found broader applications in the hospital setting given the ease and safety of placement, the advances in technology that facilitate insertion, and the growing availability of specially trained vascular nurses that place these devices at the bedside.³ Furthermore, because they are placed in deeper veins of the arm, PICCs are more durable than peripheral catheters and can support venous access for extended durations.^4-6

However, the growing use of PICCs has led to the realization that these devices are not without attendant risks. For example, PICCs are associated with venous thromboembolism (VTE) and central-line associated blood stream infection (CLABSI).^7,8 Additionally, complications such as catheter occlusion and tip migration commonly occur and may interrupt care or necessitate device removal.^9-11 Hence, thoughtful weighing of the risks against the benefits of PICC use prior to placement is necessary. To facilitate such decision-making, we developed the Michigan Appropriateness Guide for Intravenous (IV) Catheters (MAGIC) criteria,¹² which is an evidence-based tool that defines when the use of a PICC is appropriate in hospitalized adults.

The use of PICCs for infusion of peripherally compatible therapies for 5 or fewer days is rated as inappropriate by MAGIC.¹² This strategy is also endorsed by the Centers for Disease Control and Prevention’s (CDC) guidelines for the prevention of catheter-related infections.¹³ Despite these recommendations, short-term PICC use remains common. For example, a study conducted at a tertiary pediatric care center reported a trend toward shorter PICC dwell times and increasing rates of early removal.² However, factors that prompt such short-term PICC use are poorly understood. Without understanding drivers and outcomes of short-term PICC use, interventions to prevent such practice are unlikely to succeed.

Therefore, by using data from a multicenter cohort study, we examined patterns of short-term PICC use and sought to identify which patient, provider, and device factors were associated with such use. We hypothesized that short-term placement would be associated with difficult venous access and would also be associated with the risk of major and minor complications.

Study Setting and Design

We used data from the Michigan Hospital Medicine Safety (HMS) Consortium to examine patterns and predictors of short-term PICC use.¹⁴ As a multi-institutional clinical quality initiative sponsored by Blue Cross Blue Shield of Michigan and Blue Care Network, HMS aims to improve the quality of care by preventing adverse events in hospitalized medical patients.^4,15-17 In January of 2014, dedicated, trained abstractors started collecting data on PICC placements at participating HMS hospitals by using a standard protocol and template for data collection. Patients who received PICCs while admitted to either a general medicine unit or an intensive care unit (ICU) during clinical care were eligible for inclusion. Patients were excluded if they were (a) under the age of 18 years, (b) pregnant, (c) admitted to a nonmedical service (eg, surgery), or (d) admitted under observation status.

Every 14 days, each hospital collected data on the first 17 eligible patients that received a PICC, with at least 7 of these placements occurring in an ICU setting. All patients were prospectively followed until the PICC was removed, death, or until 70 days after insertion, whichever occurred first. For patients who had their PICC removed prior to hospital discharge, follow-up occurred via a review of medical records. For those discharged with a PICC in place, both medical record review and telephone follow-up were performed. To ensure data quality, annual random audits at each participating hospital were performed by the coordinating center at the University of Michigan.

For this analysis, we included all available data as of June 30, 2016. However, HMS hospitals continue to collect data on PICC use and outcomes as part of an ongoing clinical quality initiative to reduce the incidence of PICC-related complications.

Patient, Provider, and Device Data

Patient characteristics, including demographics, detailed medical history, comorbidities, physical findings, laboratory results, and medications were abstracted directly from medical records. To estimate the comorbidity burden, the Charlson-Deyo comorbidity score was calculated for each patient by using data available in the medical record at the time of PICC placement.¹⁸ Data, such as the documented indication for PICC insertion and the reason for removal, were obtained directly from medical records. Provider characteristics, including the specialty of the attending physician at the time of insertion and the type of operator who inserted the PICC, were also collected. Institutional characteristics, such as total number of beds, teaching versus nonteaching, and urban versus rural, were obtained from hospital publicly reported data and semiannual surveys of HMS sites.^19,20 Data on device characteristics, such as catheter gauge, coating, insertion attempts, tip location, and number of lumens, were abstracted from PICC insertion notes.

Outcomes of Interest

The outcome of interest was short-term PICC use, defined as PICCs removed within 5 days of insertion. Patients who expired with a PICC in situ were excluded. Secondary outcomes of interest included PICC-related complications, categorized as major (eg, symptomatic VTE and CLABSI) or minor (eg, catheter occlusion, superficial thrombosis, mechanical complications [kinking, coiling], exit site infection, and tip migration). Symptomatic VTE was defined as clinically diagnosed deep venous thrombosis (DVT) and/or pulmonary embolism (PE) not present at the time of PICC placement and confirmed via imaging (ultrasound or venogram for DVT; computed tomography scan, ventilation perfusion scan, or pulmonary angiogram for PE). CLABSI was defined in accordance with the CDC’s National Healthcare Safety Network criteria or according to Infectious Diseases Society of America recommendations.^21,22 All minor PICC complications were defined in accordance with prior published definitions.⁴

Statistical Analysis

Cases of short-term PICC use were identified and compared with patients with a PICC dwell time of 6 or more days by patient, provider, and device characteristics. The initial analyses for the associations of putative factors with short-term PICC use were performed using χ2 or Wilcoxon tests for categorical and continuous variables, respectively. Univariable mixed effect logistic regression models (with a random hospital-specific intercept) were then used to control for hospital-level clustering. Next, a mixed effects multivariable logistic regression model was used to identify factors associated with short-term PICC use. Variables with P ≤ .25 were considered as candidate predictors for the final multivariable model, which was chosen through a stepwise variable selection algorithm performed on 1000 bootstrapped data sets.²³ Variables in the final model were retained based on their frequency of selection in the bootstrapped samples, significance level, and contribution to the overall model likelihood. Results were expressed as odds ratios (OR) with corresponding 95% confidence intervals (CI). SAS for Windows (version 9.3, SAS Institute Inc., Cary, NC) was used for analyses.

Ethical and Regulatory Oversight

The study was classified as “not regulated” by the Institutional Review Board at the University of Michigan (HUM00078730).

Overall Characteristics of the Study Cohort

Characteristics of Short-Term Peripherally Inserted Central Catheter Use

Of the 15,397 PICCs included, we identified 3902 PICCs (25.3%) with a dwell time of ≤5 days (median = 3 days; IQR, 2-4 days). When compared to PICCs that were in place for longer durations, no significant differences in age or comorbidity scores were observed. Importantly, despite recommendations to avoid PICCs in patients with moderate to severe chronic kidney disease (glomerular filtration rate [GFR] ≤ 59 ml/min), 1292 (33.1%) short-term PICCs occurred in patients that met such criteria.

Among short-term PICCs, 3618 (92.7%) were power-capable devices, 2785 (71.4%) were 5-French, and 2813 (72.1%) were multilumen. Indications for the use of short-term PICCs differed from longer term devices in important ways (P <  .001). For example, the most common documented indication for short-term PICC use was difficult venous access (28.2%), while for long-term PICCs, it was antibiotic administration (39.8%). General internists and hospitalists were the most common attending physicians for patients with short-term and long-term PICCs (65.1% and 65.5%, respectively [P = .73]). Also, the proportion of critical care physicians responsible for patients with short versus long-term PICC use was similar (14.0% vs 15.0%, respectively [P = .123]). Of the short-term PICCs, 2583 (66.2%) were inserted by vascular access nurses, 795 (20.4%) by interventional radiologists, and 439 (11.3%) by advance practice professionals. Almost all of the PICCs placed ≤5 days (95.5%) were removed during hospitalization.

Complications Associated with Short-Term Peripherally Inserted Central Catheter Use

This large, multisite prospective cohort study is the first to examine patterns and predictors of short-term PICC use in hospitalized adults. By examining clinically granular data derived from the medical records of patients across 52 hospitals, we found that short-term use was common, representing 25% of all PICCs placed. Almost all such PICCs were removed prior to discharge, suggesting that they were placed primarily to meet acute needs during hospitalization. Multivariable models indicated that patients with difficult venous access, multilumen devices, and teaching hospital settings were associated with short-term use. Given that (a) short term PICC use is not recommended by published evidence-based guidelines,^12,13 (b) both major and minor complications were not uncommon despite brief exposure, and (c) specific factors might be targeted to avoid such use, strategies to improve PICC decision-making in the hospital appear increasingly necessary.

In our study, difficult venous access was the most common documented indication for short-term PICC placement. For patients in whom an anticipated catheter dwell time of 5 days or less is expected, MAGIC recommends the consideration of midline or peripheral IV catheters placed under ultrasound guidance.¹² A midline is a type of peripheral IV catheter that is about 7.5 cm to 25 cm in length and is typically inserted in the larger diameter veins of the upper extremity, such as the cephalic or basilic veins, with the tip terminating distal to the subclavian vein.^7,12 While there is a paucity of information that directly compares PICCs to midlines, some data suggest a lower risk of bloodstream infection and thrombosis associated with the latter.^24-26 For example, at one quaternary teaching hospital, house staff who are trained to insert midline catheters under ultrasound guidance in critically ill patients with difficult venous access reported no CLABSI and DVT events.²⁶

Interestingly, multilumen catheters were used twice as often as single lumen catheters in patients with short-term PICCs. In these instances, the use of additional lumens is questionable, as infusion of multiple incompatible fluids was not commonly listed as an indication prompting PICC use. Because multilumen PICCs are associated with higher risks of both VTE and CLABSI compared to single lumen devices, such use represents an important safety concern.^27-29 Institutional efforts that not only limit the use of multilumen PICCs but also fundamentally define when use of a PICC is appropriate may substantially improve outcomes related to vascular access.^28,30,31We observed that short-term PICCs were more common in teaching compared to nonteaching hospitals. While the design of the present study precludes understanding the reasons for such a difference, some plausible theories include the presence of physician trainees who may not appreciate the risks of PICC use, diminishing peripheral IV access securement skills, and the lack of alternatives to PICC use. Educating trainees who most often order PICCs in teaching settings as to when they should or should not consider this device may represent an important quality improvement opportunity.³² Similarly, auditing and assessing the clinical skills of those entrusted to place peripheral IVs might prove helpful.^33,34 Finally, the introduction of a midline program, or similar programs that expand the scope of vascular access teams to place alternative devices, should be explored as a means to improve PICC use and patient safety.

Our study also found that a third of patients who received PICCs for 5 or fewer days had moderate to severe chronic kidney disease. In these patients who may require renal replacement therapy, prior PICC placement is among the strongest predictors of arteriovenous fistula failure.^35,36 Therefore, even though national guidelines discourage the use of PICCs in these patients and recommend alternative routes of venous access,^12,37,38 such practice is clearly not happening. System-based interventions that begin by identifying patients who require vein preservation (eg, those with a GFR < 45 ml/min) and are therefore not appropriate for a PICC would be a welcomed first step in improving care for such patients.^37,38Our study has limitations. First, the observational nature of the study limits the ability to assess for causality or to account for the effects of unmeasured confounders. Second, while the use of medical records to collect granular data is valuable, differences in documentation patterns within and across hospitals, including patterns of missing data, may produce a misclassification of covariates or outcomes. Third, while we found that higher rates of short-term PICC use were associated with teaching hospitals and patients with difficult venous access, we were unable to determine the precise reasons for this practice trend. Qualitative or mixed-methods approaches to understand provider decision-making in these settings would be welcomed.

Our study also has several strengths. First, to our knowledge, this is the first study to systematically describe and evaluate patterns and predictors of short-term PICC use. The finding that PICCs placed for difficult venous access is a dominant category of short-term placement confirms clinical suspicions regarding inappropriate use and strengthens the need for pathways or protocols to manage such patients. Second, the inclusion of medical patients in diverse institutions offers not only real-world insights related to PICC use, but also offers findings that should be generalizable to other hospitals and health systems. Third, the use of a robust data collection strategy that emphasized standardized data collection, dedicated trained abstractors, and random audits to ensure data quality strengthen the findings of this work. Finally, our findings highlight an urgent need to develop policies related to PICC use, including limiting the use of multiple lumens and avoidance in patients with moderate to severe kidney disease.

In conclusion, short-term use of PICCs is prevalent and associated with key patient, provider, and device factors. Such use is also associated with complications, such as catheter occlusion, tip migration, VTE, and CLABSI. Limiting the use of multiple-lumen PICCs, enhancing education for when a PICC should be used, and defining strategies for patients with difficult access may help reduce inappropriate PICC use and improve patient safety. Future studies to examine implementation of such interventions would be welcomed.

Disclosure: Drs. Paje, Conlon, Swaminathan, and Boldenow disclose no conflicts of interest. Dr. Chopra has received honoraria for talks at hospitals as a visiting professor. Dr. Flanders discloses consultancies for the Institute for Healthcare Improvement and the Society of Hospital Medicine, royalties from Wiley Publishing, honoraria for various talks at hospitals as a visiting professor, grants from the CDC Foundation, Agency for Healthcare Research and Quality, Blue Cross Blue Shield of Michigan (BCBSM), and Michigan Hospital Association, and expert witness testimony. Dr. Bernstein discloses consultancies for Blue Care Network and grants from BCBSM, Department of Veterans Affairs, and National Institutes of Health. Dr. Kaatz discloses no relevant conflicts of interest. BCBSM and Blue Care Network provided support for the Michigan HMS Consortium as part of the BCBSM Value Partnerships program. Although BCBSM and HMS work collaboratively, the opinions, beliefs, and viewpoints expressed by the author do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. Dr. Chopra is supported by a career development award from the Agency for Healthcare Research and Quality (1-K08-HS022835-01). BCBSM and Blue Care Network supported data collection at each participating site and funded the data coordinating center but had no role in study concept, interpretation of findings, or in the preparation, final approval, or decision to submit the manuscript.

Peripherally inserted central catheters (PICCs) are integral to the care of hospitalized patients in the United States.¹ Consequently, utilization of these devices in acutely ill patients has steadily increased in the past decade.² Although originally designed to support the delivery of total parenteral nutrition, PICCs have found broader applications in the hospital setting given the ease and safety of placement, the advances in technology that facilitate insertion, and the growing availability of specially trained vascular nurses that place these devices at the bedside.³ Furthermore, because they are placed in deeper veins of the arm, PICCs are more durable than peripheral catheters and can support venous access for extended durations.^4-6

However, the growing use of PICCs has led to the realization that these devices are not without attendant risks. For example, PICCs are associated with venous thromboembolism (VTE) and central-line associated blood stream infection (CLABSI).^7,8 Additionally, complications such as catheter occlusion and tip migration commonly occur and may interrupt care or necessitate device removal.^9-11 Hence, thoughtful weighing of the risks against the benefits of PICC use prior to placement is necessary. To facilitate such decision-making, we developed the Michigan Appropriateness Guide for Intravenous (IV) Catheters (MAGIC) criteria,¹² which is an evidence-based tool that defines when the use of a PICC is appropriate in hospitalized adults.

The use of PICCs for infusion of peripherally compatible therapies for 5 or fewer days is rated as inappropriate by MAGIC.¹² This strategy is also endorsed by the Centers for Disease Control and Prevention’s (CDC) guidelines for the prevention of catheter-related infections.¹³ Despite these recommendations, short-term PICC use remains common. For example, a study conducted at a tertiary pediatric care center reported a trend toward shorter PICC dwell times and increasing rates of early removal.² However, factors that prompt such short-term PICC use are poorly understood. Without understanding drivers and outcomes of short-term PICC use, interventions to prevent such practice are unlikely to succeed.

Therefore, by using data from a multicenter cohort study, we examined patterns of short-term PICC use and sought to identify which patient, provider, and device factors were associated with such use. We hypothesized that short-term placement would be associated with difficult venous access and would also be associated with the risk of major and minor complications.

Study Setting and Design

We used data from the Michigan Hospital Medicine Safety (HMS) Consortium to examine patterns and predictors of short-term PICC use.¹⁴ As a multi-institutional clinical quality initiative sponsored by Blue Cross Blue Shield of Michigan and Blue Care Network, HMS aims to improve the quality of care by preventing adverse events in hospitalized medical patients.^4,15-17 In January of 2014, dedicated, trained abstractors started collecting data on PICC placements at participating HMS hospitals by using a standard protocol and template for data collection. Patients who received PICCs while admitted to either a general medicine unit or an intensive care unit (ICU) during clinical care were eligible for inclusion. Patients were excluded if they were (a) under the age of 18 years, (b) pregnant, (c) admitted to a nonmedical service (eg, surgery), or (d) admitted under observation status.

Every 14 days, each hospital collected data on the first 17 eligible patients that received a PICC, with at least 7 of these placements occurring in an ICU setting. All patients were prospectively followed until the PICC was removed, death, or until 70 days after insertion, whichever occurred first. For patients who had their PICC removed prior to hospital discharge, follow-up occurred via a review of medical records. For those discharged with a PICC in place, both medical record review and telephone follow-up were performed. To ensure data quality, annual random audits at each participating hospital were performed by the coordinating center at the University of Michigan.

For this analysis, we included all available data as of June 30, 2016. However, HMS hospitals continue to collect data on PICC use and outcomes as part of an ongoing clinical quality initiative to reduce the incidence of PICC-related complications.

Patient, Provider, and Device Data

Patient characteristics, including demographics, detailed medical history, comorbidities, physical findings, laboratory results, and medications were abstracted directly from medical records. To estimate the comorbidity burden, the Charlson-Deyo comorbidity score was calculated for each patient by using data available in the medical record at the time of PICC placement.¹⁸ Data, such as the documented indication for PICC insertion and the reason for removal, were obtained directly from medical records. Provider characteristics, including the specialty of the attending physician at the time of insertion and the type of operator who inserted the PICC, were also collected. Institutional characteristics, such as total number of beds, teaching versus nonteaching, and urban versus rural, were obtained from hospital publicly reported data and semiannual surveys of HMS sites.^19,20 Data on device characteristics, such as catheter gauge, coating, insertion attempts, tip location, and number of lumens, were abstracted from PICC insertion notes.

Outcomes of Interest

The outcome of interest was short-term PICC use, defined as PICCs removed within 5 days of insertion. Patients who expired with a PICC in situ were excluded. Secondary outcomes of interest included PICC-related complications, categorized as major (eg, symptomatic VTE and CLABSI) or minor (eg, catheter occlusion, superficial thrombosis, mechanical complications [kinking, coiling], exit site infection, and tip migration). Symptomatic VTE was defined as clinically diagnosed deep venous thrombosis (DVT) and/or pulmonary embolism (PE) not present at the time of PICC placement and confirmed via imaging (ultrasound or venogram for DVT; computed tomography scan, ventilation perfusion scan, or pulmonary angiogram for PE). CLABSI was defined in accordance with the CDC’s National Healthcare Safety Network criteria or according to Infectious Diseases Society of America recommendations.^21,22 All minor PICC complications were defined in accordance with prior published definitions.⁴

Statistical Analysis

Cases of short-term PICC use were identified and compared with patients with a PICC dwell time of 6 or more days by patient, provider, and device characteristics. The initial analyses for the associations of putative factors with short-term PICC use were performed using χ2 or Wilcoxon tests for categorical and continuous variables, respectively. Univariable mixed effect logistic regression models (with a random hospital-specific intercept) were then used to control for hospital-level clustering. Next, a mixed effects multivariable logistic regression model was used to identify factors associated with short-term PICC use. Variables with P ≤ .25 were considered as candidate predictors for the final multivariable model, which was chosen through a stepwise variable selection algorithm performed on 1000 bootstrapped data sets.²³ Variables in the final model were retained based on their frequency of selection in the bootstrapped samples, significance level, and contribution to the overall model likelihood. Results were expressed as odds ratios (OR) with corresponding 95% confidence intervals (CI). SAS for Windows (version 9.3, SAS Institute Inc., Cary, NC) was used for analyses.

Ethical and Regulatory Oversight

The study was classified as “not regulated” by the Institutional Review Board at the University of Michigan (HUM00078730).

Overall Characteristics of the Study Cohort

Characteristics of Short-Term Peripherally Inserted Central Catheter Use

Of the 15,397 PICCs included, we identified 3902 PICCs (25.3%) with a dwell time of ≤5 days (median = 3 days; IQR, 2-4 days). When compared to PICCs that were in place for longer durations, no significant differences in age or comorbidity scores were observed. Importantly, despite recommendations to avoid PICCs in patients with moderate to severe chronic kidney disease (glomerular filtration rate [GFR] ≤ 59 ml/min), 1292 (33.1%) short-term PICCs occurred in patients that met such criteria.

Among short-term PICCs, 3618 (92.7%) were power-capable devices, 2785 (71.4%) were 5-French, and 2813 (72.1%) were multilumen. Indications for the use of short-term PICCs differed from longer term devices in important ways (P <  .001). For example, the most common documented indication for short-term PICC use was difficult venous access (28.2%), while for long-term PICCs, it was antibiotic administration (39.8%). General internists and hospitalists were the most common attending physicians for patients with short-term and long-term PICCs (65.1% and 65.5%, respectively [P = .73]). Also, the proportion of critical care physicians responsible for patients with short versus long-term PICC use was similar (14.0% vs 15.0%, respectively [P = .123]). Of the short-term PICCs, 2583 (66.2%) were inserted by vascular access nurses, 795 (20.4%) by interventional radiologists, and 439 (11.3%) by advance practice professionals. Almost all of the PICCs placed ≤5 days (95.5%) were removed during hospitalization.

Complications Associated with Short-Term Peripherally Inserted Central Catheter Use

This large, multisite prospective cohort study is the first to examine patterns and predictors of short-term PICC use in hospitalized adults. By examining clinically granular data derived from the medical records of patients across 52 hospitals, we found that short-term use was common, representing 25% of all PICCs placed. Almost all such PICCs were removed prior to discharge, suggesting that they were placed primarily to meet acute needs during hospitalization. Multivariable models indicated that patients with difficult venous access, multilumen devices, and teaching hospital settings were associated with short-term use. Given that (a) short term PICC use is not recommended by published evidence-based guidelines,^12,13 (b) both major and minor complications were not uncommon despite brief exposure, and (c) specific factors might be targeted to avoid such use, strategies to improve PICC decision-making in the hospital appear increasingly necessary.

In our study, difficult venous access was the most common documented indication for short-term PICC placement. For patients in whom an anticipated catheter dwell time of 5 days or less is expected, MAGIC recommends the consideration of midline or peripheral IV catheters placed under ultrasound guidance.¹² A midline is a type of peripheral IV catheter that is about 7.5 cm to 25 cm in length and is typically inserted in the larger diameter veins of the upper extremity, such as the cephalic or basilic veins, with the tip terminating distal to the subclavian vein.^7,12 While there is a paucity of information that directly compares PICCs to midlines, some data suggest a lower risk of bloodstream infection and thrombosis associated with the latter.^24-26 For example, at one quaternary teaching hospital, house staff who are trained to insert midline catheters under ultrasound guidance in critically ill patients with difficult venous access reported no CLABSI and DVT events.²⁶

Interestingly, multilumen catheters were used twice as often as single lumen catheters in patients with short-term PICCs. In these instances, the use of additional lumens is questionable, as infusion of multiple incompatible fluids was not commonly listed as an indication prompting PICC use. Because multilumen PICCs are associated with higher risks of both VTE and CLABSI compared to single lumen devices, such use represents an important safety concern.^27-29 Institutional efforts that not only limit the use of multilumen PICCs but also fundamentally define when use of a PICC is appropriate may substantially improve outcomes related to vascular access.^28,30,31We observed that short-term PICCs were more common in teaching compared to nonteaching hospitals. While the design of the present study precludes understanding the reasons for such a difference, some plausible theories include the presence of physician trainees who may not appreciate the risks of PICC use, diminishing peripheral IV access securement skills, and the lack of alternatives to PICC use. Educating trainees who most often order PICCs in teaching settings as to when they should or should not consider this device may represent an important quality improvement opportunity.³² Similarly, auditing and assessing the clinical skills of those entrusted to place peripheral IVs might prove helpful.^33,34 Finally, the introduction of a midline program, or similar programs that expand the scope of vascular access teams to place alternative devices, should be explored as a means to improve PICC use and patient safety.

Our study also found that a third of patients who received PICCs for 5 or fewer days had moderate to severe chronic kidney disease. In these patients who may require renal replacement therapy, prior PICC placement is among the strongest predictors of arteriovenous fistula failure.^35,36 Therefore, even though national guidelines discourage the use of PICCs in these patients and recommend alternative routes of venous access,^12,37,38 such practice is clearly not happening. System-based interventions that begin by identifying patients who require vein preservation (eg, those with a GFR < 45 ml/min) and are therefore not appropriate for a PICC would be a welcomed first step in improving care for such patients.^37,38Our study has limitations. First, the observational nature of the study limits the ability to assess for causality or to account for the effects of unmeasured confounders. Second, while the use of medical records to collect granular data is valuable, differences in documentation patterns within and across hospitals, including patterns of missing data, may produce a misclassification of covariates or outcomes. Third, while we found that higher rates of short-term PICC use were associated with teaching hospitals and patients with difficult venous access, we were unable to determine the precise reasons for this practice trend. Qualitative or mixed-methods approaches to understand provider decision-making in these settings would be welcomed.

Our study also has several strengths. First, to our knowledge, this is the first study to systematically describe and evaluate patterns and predictors of short-term PICC use. The finding that PICCs placed for difficult venous access is a dominant category of short-term placement confirms clinical suspicions regarding inappropriate use and strengthens the need for pathways or protocols to manage such patients. Second, the inclusion of medical patients in diverse institutions offers not only real-world insights related to PICC use, but also offers findings that should be generalizable to other hospitals and health systems. Third, the use of a robust data collection strategy that emphasized standardized data collection, dedicated trained abstractors, and random audits to ensure data quality strengthen the findings of this work. Finally, our findings highlight an urgent need to develop policies related to PICC use, including limiting the use of multiple lumens and avoidance in patients with moderate to severe kidney disease.

In conclusion, short-term use of PICCs is prevalent and associated with key patient, provider, and device factors. Such use is also associated with complications, such as catheter occlusion, tip migration, VTE, and CLABSI. Limiting the use of multiple-lumen PICCs, enhancing education for when a PICC should be used, and defining strategies for patients with difficult access may help reduce inappropriate PICC use and improve patient safety. Future studies to examine implementation of such interventions would be welcomed.

Disclosure: Drs. Paje, Conlon, Swaminathan, and Boldenow disclose no conflicts of interest. Dr. Chopra has received honoraria for talks at hospitals as a visiting professor. Dr. Flanders discloses consultancies for the Institute for Healthcare Improvement and the Society of Hospital Medicine, royalties from Wiley Publishing, honoraria for various talks at hospitals as a visiting professor, grants from the CDC Foundation, Agency for Healthcare Research and Quality, Blue Cross Blue Shield of Michigan (BCBSM), and Michigan Hospital Association, and expert witness testimony. Dr. Bernstein discloses consultancies for Blue Care Network and grants from BCBSM, Department of Veterans Affairs, and National Institutes of Health. Dr. Kaatz discloses no relevant conflicts of interest. BCBSM and Blue Care Network provided support for the Michigan HMS Consortium as part of the BCBSM Value Partnerships program. Although BCBSM and HMS work collaboratively, the opinions, beliefs, and viewpoints expressed by the author do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. Dr. Chopra is supported by a career development award from the Agency for Healthcare Research and Quality (1-K08-HS022835-01). BCBSM and Blue Care Network supported data collection at each participating site and funded the data coordinating center but had no role in study concept, interpretation of findings, or in the preparation, final approval, or decision to submit the manuscript.

Peripherally inserted central catheters (PICCs) are integral to the care of hospitalized patients in the United States.¹ Consequently, utilization of these devices in acutely ill patients has steadily increased in the past decade.² Although originally designed to support the delivery of total parenteral nutrition, PICCs have found broader applications in the hospital setting given the ease and safety of placement, the advances in technology that facilitate insertion, and the growing availability of specially trained vascular nurses that place these devices at the bedside.³ Furthermore, because they are placed in deeper veins of the arm, PICCs are more durable than peripheral catheters and can support venous access for extended durations.^4-6

However, the growing use of PICCs has led to the realization that these devices are not without attendant risks. For example, PICCs are associated with venous thromboembolism (VTE) and central-line associated blood stream infection (CLABSI).^7,8 Additionally, complications such as catheter occlusion and tip migration commonly occur and may interrupt care or necessitate device removal.^9-11 Hence, thoughtful weighing of the risks against the benefits of PICC use prior to placement is necessary. To facilitate such decision-making, we developed the Michigan Appropriateness Guide for Intravenous (IV) Catheters (MAGIC) criteria,¹² which is an evidence-based tool that defines when the use of a PICC is appropriate in hospitalized adults.

The use of PICCs for infusion of peripherally compatible therapies for 5 or fewer days is rated as inappropriate by MAGIC.¹² This strategy is also endorsed by the Centers for Disease Control and Prevention’s (CDC) guidelines for the prevention of catheter-related infections.¹³ Despite these recommendations, short-term PICC use remains common. For example, a study conducted at a tertiary pediatric care center reported a trend toward shorter PICC dwell times and increasing rates of early removal.² However, factors that prompt such short-term PICC use are poorly understood. Without understanding drivers and outcomes of short-term PICC use, interventions to prevent such practice are unlikely to succeed.

Therefore, by using data from a multicenter cohort study, we examined patterns of short-term PICC use and sought to identify which patient, provider, and device factors were associated with such use. We hypothesized that short-term placement would be associated with difficult venous access and would also be associated with the risk of major and minor complications.

Study Setting and Design

We used data from the Michigan Hospital Medicine Safety (HMS) Consortium to examine patterns and predictors of short-term PICC use.¹⁴ As a multi-institutional clinical quality initiative sponsored by Blue Cross Blue Shield of Michigan and Blue Care Network, HMS aims to improve the quality of care by preventing adverse events in hospitalized medical patients.^4,15-17 In January of 2014, dedicated, trained abstractors started collecting data on PICC placements at participating HMS hospitals by using a standard protocol and template for data collection. Patients who received PICCs while admitted to either a general medicine unit or an intensive care unit (ICU) during clinical care were eligible for inclusion. Patients were excluded if they were (a) under the age of 18 years, (b) pregnant, (c) admitted to a nonmedical service (eg, surgery), or (d) admitted under observation status.

Every 14 days, each hospital collected data on the first 17 eligible patients that received a PICC, with at least 7 of these placements occurring in an ICU setting. All patients were prospectively followed until the PICC was removed, death, or until 70 days after insertion, whichever occurred first. For patients who had their PICC removed prior to hospital discharge, follow-up occurred via a review of medical records. For those discharged with a PICC in place, both medical record review and telephone follow-up were performed. To ensure data quality, annual random audits at each participating hospital were performed by the coordinating center at the University of Michigan.

For this analysis, we included all available data as of June 30, 2016. However, HMS hospitals continue to collect data on PICC use and outcomes as part of an ongoing clinical quality initiative to reduce the incidence of PICC-related complications.

Patient, Provider, and Device Data

Patient characteristics, including demographics, detailed medical history, comorbidities, physical findings, laboratory results, and medications were abstracted directly from medical records. To estimate the comorbidity burden, the Charlson-Deyo comorbidity score was calculated for each patient by using data available in the medical record at the time of PICC placement.¹⁸ Data, such as the documented indication for PICC insertion and the reason for removal, were obtained directly from medical records. Provider characteristics, including the specialty of the attending physician at the time of insertion and the type of operator who inserted the PICC, were also collected. Institutional characteristics, such as total number of beds, teaching versus nonteaching, and urban versus rural, were obtained from hospital publicly reported data and semiannual surveys of HMS sites.^19,20 Data on device characteristics, such as catheter gauge, coating, insertion attempts, tip location, and number of lumens, were abstracted from PICC insertion notes.

Outcomes of Interest

The outcome of interest was short-term PICC use, defined as PICCs removed within 5 days of insertion. Patients who expired with a PICC in situ were excluded. Secondary outcomes of interest included PICC-related complications, categorized as major (eg, symptomatic VTE and CLABSI) or minor (eg, catheter occlusion, superficial thrombosis, mechanical complications [kinking, coiling], exit site infection, and tip migration). Symptomatic VTE was defined as clinically diagnosed deep venous thrombosis (DVT) and/or pulmonary embolism (PE) not present at the time of PICC placement and confirmed via imaging (ultrasound or venogram for DVT; computed tomography scan, ventilation perfusion scan, or pulmonary angiogram for PE). CLABSI was defined in accordance with the CDC’s National Healthcare Safety Network criteria or according to Infectious Diseases Society of America recommendations.^21,22 All minor PICC complications were defined in accordance with prior published definitions.⁴

Statistical Analysis

Cases of short-term PICC use were identified and compared with patients with a PICC dwell time of 6 or more days by patient, provider, and device characteristics. The initial analyses for the associations of putative factors with short-term PICC use were performed using χ2 or Wilcoxon tests for categorical and continuous variables, respectively. Univariable mixed effect logistic regression models (with a random hospital-specific intercept) were then used to control for hospital-level clustering. Next, a mixed effects multivariable logistic regression model was used to identify factors associated with short-term PICC use. Variables with P ≤ .25 were considered as candidate predictors for the final multivariable model, which was chosen through a stepwise variable selection algorithm performed on 1000 bootstrapped data sets.²³ Variables in the final model were retained based on their frequency of selection in the bootstrapped samples, significance level, and contribution to the overall model likelihood. Results were expressed as odds ratios (OR) with corresponding 95% confidence intervals (CI). SAS for Windows (version 9.3, SAS Institute Inc., Cary, NC) was used for analyses.

Ethical and Regulatory Oversight

The study was classified as “not regulated” by the Institutional Review Board at the University of Michigan (HUM00078730).

Overall Characteristics of the Study Cohort

Characteristics of Short-Term Peripherally Inserted Central Catheter Use

Of the 15,397 PICCs included, we identified 3902 PICCs (25.3%) with a dwell time of ≤5 days (median = 3 days; IQR, 2-4 days). When compared to PICCs that were in place for longer durations, no significant differences in age or comorbidity scores were observed. Importantly, despite recommendations to avoid PICCs in patients with moderate to severe chronic kidney disease (glomerular filtration rate [GFR] ≤ 59 ml/min), 1292 (33.1%) short-term PICCs occurred in patients that met such criteria.

Among short-term PICCs, 3618 (92.7%) were power-capable devices, 2785 (71.4%) were 5-French, and 2813 (72.1%) were multilumen. Indications for the use of short-term PICCs differed from longer term devices in important ways (P <  .001). For example, the most common documented indication for short-term PICC use was difficult venous access (28.2%), while for long-term PICCs, it was antibiotic administration (39.8%). General internists and hospitalists were the most common attending physicians for patients with short-term and long-term PICCs (65.1% and 65.5%, respectively [P = .73]). Also, the proportion of critical care physicians responsible for patients with short versus long-term PICC use was similar (14.0% vs 15.0%, respectively [P = .123]). Of the short-term PICCs, 2583 (66.2%) were inserted by vascular access nurses, 795 (20.4%) by interventional radiologists, and 439 (11.3%) by advance practice professionals. Almost all of the PICCs placed ≤5 days (95.5%) were removed during hospitalization.

Complications Associated with Short-Term Peripherally Inserted Central Catheter Use

This large, multisite prospective cohort study is the first to examine patterns and predictors of short-term PICC use in hospitalized adults. By examining clinically granular data derived from the medical records of patients across 52 hospitals, we found that short-term use was common, representing 25% of all PICCs placed. Almost all such PICCs were removed prior to discharge, suggesting that they were placed primarily to meet acute needs during hospitalization. Multivariable models indicated that patients with difficult venous access, multilumen devices, and teaching hospital settings were associated with short-term use. Given that (a) short term PICC use is not recommended by published evidence-based guidelines,^12,13 (b) both major and minor complications were not uncommon despite brief exposure, and (c) specific factors might be targeted to avoid such use, strategies to improve PICC decision-making in the hospital appear increasingly necessary.

In our study, difficult venous access was the most common documented indication for short-term PICC placement. For patients in whom an anticipated catheter dwell time of 5 days or less is expected, MAGIC recommends the consideration of midline or peripheral IV catheters placed under ultrasound guidance.¹² A midline is a type of peripheral IV catheter that is about 7.5 cm to 25 cm in length and is typically inserted in the larger diameter veins of the upper extremity, such as the cephalic or basilic veins, with the tip terminating distal to the subclavian vein.^7,12 While there is a paucity of information that directly compares PICCs to midlines, some data suggest a lower risk of bloodstream infection and thrombosis associated with the latter.^24-26 For example, at one quaternary teaching hospital, house staff who are trained to insert midline catheters under ultrasound guidance in critically ill patients with difficult venous access reported no CLABSI and DVT events.²⁶

Interestingly, multilumen catheters were used twice as often as single lumen catheters in patients with short-term PICCs. In these instances, the use of additional lumens is questionable, as infusion of multiple incompatible fluids was not commonly listed as an indication prompting PICC use. Because multilumen PICCs are associated with higher risks of both VTE and CLABSI compared to single lumen devices, such use represents an important safety concern.^27-29 Institutional efforts that not only limit the use of multilumen PICCs but also fundamentally define when use of a PICC is appropriate may substantially improve outcomes related to vascular access.^28,30,31We observed that short-term PICCs were more common in teaching compared to nonteaching hospitals. While the design of the present study precludes understanding the reasons for such a difference, some plausible theories include the presence of physician trainees who may not appreciate the risks of PICC use, diminishing peripheral IV access securement skills, and the lack of alternatives to PICC use. Educating trainees who most often order PICCs in teaching settings as to when they should or should not consider this device may represent an important quality improvement opportunity.³² Similarly, auditing and assessing the clinical skills of those entrusted to place peripheral IVs might prove helpful.^33,34 Finally, the introduction of a midline program, or similar programs that expand the scope of vascular access teams to place alternative devices, should be explored as a means to improve PICC use and patient safety.

Our study also found that a third of patients who received PICCs for 5 or fewer days had moderate to severe chronic kidney disease. In these patients who may require renal replacement therapy, prior PICC placement is among the strongest predictors of arteriovenous fistula failure.^35,36 Therefore, even though national guidelines discourage the use of PICCs in these patients and recommend alternative routes of venous access,^12,37,38 such practice is clearly not happening. System-based interventions that begin by identifying patients who require vein preservation (eg, those with a GFR < 45 ml/min) and are therefore not appropriate for a PICC would be a welcomed first step in improving care for such patients.^37,38Our study has limitations. First, the observational nature of the study limits the ability to assess for causality or to account for the effects of unmeasured confounders. Second, while the use of medical records to collect granular data is valuable, differences in documentation patterns within and across hospitals, including patterns of missing data, may produce a misclassification of covariates or outcomes. Third, while we found that higher rates of short-term PICC use were associated with teaching hospitals and patients with difficult venous access, we were unable to determine the precise reasons for this practice trend. Qualitative or mixed-methods approaches to understand provider decision-making in these settings would be welcomed.

Our study also has several strengths. First, to our knowledge, this is the first study to systematically describe and evaluate patterns and predictors of short-term PICC use. The finding that PICCs placed for difficult venous access is a dominant category of short-term placement confirms clinical suspicions regarding inappropriate use and strengthens the need for pathways or protocols to manage such patients. Second, the inclusion of medical patients in diverse institutions offers not only real-world insights related to PICC use, but also offers findings that should be generalizable to other hospitals and health systems. Third, the use of a robust data collection strategy that emphasized standardized data collection, dedicated trained abstractors, and random audits to ensure data quality strengthen the findings of this work. Finally, our findings highlight an urgent need to develop policies related to PICC use, including limiting the use of multiple lumens and avoidance in patients with moderate to severe kidney disease.

In conclusion, short-term use of PICCs is prevalent and associated with key patient, provider, and device factors. Such use is also associated with complications, such as catheter occlusion, tip migration, VTE, and CLABSI. Limiting the use of multiple-lumen PICCs, enhancing education for when a PICC should be used, and defining strategies for patients with difficult access may help reduce inappropriate PICC use and improve patient safety. Future studies to examine implementation of such interventions would be welcomed.

Disclosure: Drs. Paje, Conlon, Swaminathan, and Boldenow disclose no conflicts of interest. Dr. Chopra has received honoraria for talks at hospitals as a visiting professor. Dr. Flanders discloses consultancies for the Institute for Healthcare Improvement and the Society of Hospital Medicine, royalties from Wiley Publishing, honoraria for various talks at hospitals as a visiting professor, grants from the CDC Foundation, Agency for Healthcare Research and Quality, Blue Cross Blue Shield of Michigan (BCBSM), and Michigan Hospital Association, and expert witness testimony. Dr. Bernstein discloses consultancies for Blue Care Network and grants from BCBSM, Department of Veterans Affairs, and National Institutes of Health. Dr. Kaatz discloses no relevant conflicts of interest. BCBSM and Blue Care Network provided support for the Michigan HMS Consortium as part of the BCBSM Value Partnerships program. Although BCBSM and HMS work collaboratively, the opinions, beliefs, and viewpoints expressed by the author do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. Dr. Chopra is supported by a career development award from the Agency for Healthcare Research and Quality (1-K08-HS022835-01). BCBSM and Blue Care Network supported data collection at each participating site and funded the data coordinating center but had no role in study concept, interpretation of findings, or in the preparation, final approval, or decision to submit the manuscript.

Annual healthcare costs in the United States are over $3 trillion and are garnering significant national attention.¹ The United States spends approximately 2.5 times more per capita on healthcare when compared to other developed nations.² One source of unnecessary cost in healthcare is defensive medicine. Defensive medicine has been defined by Congress as occurring “when doctors order tests, procedures, or visits, or avoid certain high-risk patients or procedures, primarily (but not necessarily) because of concern about malpractice liability.”³

Though difficult to assess, in 1 study, defensive medicine was estimated to cost $45 billion annually.⁴ While general agreement exists that physicians practice defensive medicine, the extent of defensive practices and the subsequent impact on healthcare costs remain unclear. This is especially true for a group of clinicians that is rapidly increasing in number: hospitalists. Currently, there are more than 50,000 hospitalists in the United States,⁵ yet the prevalence of defensive medicine in this relatively new specialty is unknown. Inpatient care is complex and time constraints can impede establishing an optimal therapeutic relationship with the patient, potentially raising liability fears. We therefore sought to quantify hospitalist physician estimates of the cost of defensive medicine and assess correlates of their estimates. As being sued might spur defensive behaviors, we also assessed how many hospitalists reported being sued and whether this was associated with their estimates of defensive medicine.

Survey Questionnaire

In a previously published survey-based analysis, we reported on physician practice and overuse for 2 common scenarios in hospital medicine: preoperative evaluation and management of uncomplicated syncope.⁶ After responding to the vignettes, each physician was asked to provide demographic and employment information and malpractice history. In addition, they were asked the following: In your best estimation, what percentage of healthcare-related resources (eg, hospital admissions, diagnostic testing, treatment) are spent purely because of defensive medicine concerns? __________% resources

Survey Sample & Administration

The survey was sent to a sample of 1753 hospitalists, randomly identified through the Society of Hospital Medicine’s (SHM) database of members and annual meeting attendees. It is estimated that almost 30% of practicing hospitalists in the United States are members of the SHM.⁵ A full description of the sampling methodology was previously published.⁶ Selected hospitalists were mailed surveys, a $20 financial incentive, and subsequent reminders between June and October 2011.

The study was exempted from institutional review board review by the University of Michigan and the VA Ann Arbor Healthcare System.

Variables

The primary outcome of interest was the response to the “% resources” estimated to be spent on defensive medicine. This was analyzed as a continuous variable. Independent variables included the following: VA employment, malpractice insurance payer, employer, history of malpractice lawsuit, sex, race, and years practicing as a physician.

Statistical Analysis

Analyses were conducted using SAS, version 9.4 (SAS Institute). Descriptive statistics were first calculated for all variables. Next, bivariable comparisons between the outcome variables and other variables of interest were performed. Multivariable comparisons were made using linear regression for the outcome of estimated resources spent on defensive medicine. A P value of < 0.05 was considered statistically significant.

Of the 1753 surveys mailed, 253 were excluded due to incorrect addresses or because the recipients were not practicing hospitalists. A total of 1020 were completed and returned, yielding a 68% response rate (1020 out of 1500 eligible). The hospitalist respondents were in practice for an average of 11 years (range 1-40 years). Respondents represented all 50 states and had a diverse background of experience and demographic characteristics, which has been previously described.⁶

Resources Estimated Spent on Defensive Medicine

Hospitalists reported, on average, that they believed defensive medicine accounted for 37.5% (standard deviation, 20.2%) of all healthcare spending. Results from the multivariable regression are presented in the Table. Hospitalists affiliated with a VA hospital reported 5.5% less in resources spent on defensive medicine than those not affiliated with a VA hospital (32.2% VA vs 37.7% non-VA, P = 0.025). For every 10 years in practice, the estimate of resources spent on defensive medicine decreased by 3% (P = 0.003). Those who were male (36.4% male vs 39.4% female, P = 0.023) and non-Hispanic white (32.5% non-Hispanic white vs 44.7% other, P ≤ 0.001) also estimated less resources spent on defensive medicine. We did not find an association between a hospitalist reporting being sued and their perception of resources spent on defensive medicine.  

Risk of Being Sued

Over a quarter of our sample (25.6%) reported having been sued at least once for medical malpractice. The proportion of hospitalists that reported a history of being sued generally increased with more years of practice (Figure). For those who had been in practice for at least 20 years, more than half (55%) had been sued at least once during their career.

In a national survey, hospitalists estimated that almost 40% of all healthcare-related resources are spent purely because of defensive medicine concerns. This estimate was affected by personal demographic and employment factors. Our second major finding is that over one-quarter of a large random sample of hospitalist physicians reported being sued for malpractice.

Hospitalist perceptions of defensive medicine varied significantly based on employment at a VA hospital, with VA-affiliated hospitalists reporting less estimated spending on defensive medicine. This effect may reflect a less litigious environment within the VA, even though physicians practicing within the VA can be reported to the National Practitioner Data Bank.⁷ The different environment may be due to the VA’s patient mix (VA patients tend to be poorer, older, sicker, and have more mental illness)⁸; however, it could also be due to its de facto practice of a form of enterprise liability, in which, by law, the VA assumes responsibility for negligence, sheltering its physicians from direct liability.

We also found that the higher the number of years a hospitalist reported practicing, the lower the perception of resources being spent on defensive medicine. The reason for this finding is unclear. There has been a recent focus on high-value care and overspending, and perhaps younger hospitalists are more aware of these initiatives and thus have higher estimates. Additionally, non-Hispanic white male respondents estimated a lower amount spent on defensive medicine compared with other respondents. This is consistent with previous studies of risk perception which have noted a “white male effect” in which white males generally perceive a wide range of risks to be lower than female and non-white individuals, likely due to sociopolitical factors.⁹ Here, the white male effect is particularly interesting, considering that male physicians are almost 2.5 times as likely as female physicians to report being sued.¹⁰

Similar to prior studies,¹¹ there was no association with personal liability claim experience and perceived resources spent on defensive medicine. It is unclear why personal experience of being sued does not appear to be associated with perceptions of defensive medicine practice. It is possible that the fear of being sued is worse than the actual experience or that physicians believe that lawsuits are either random events or inevitable and, as a result, do not change their practice patterns.

The lifetime risk of being named in a malpractice suit is substantial for hospitalists: in our study, over half of hospitalists in practice for 20 years or more reported they had been sued. This corresponds with the projection made by Jena and colleagues,¹² which estimated that 55% of internal medicine physicians will be sued by the age of 45, a number just slightly higher than the average for all physicians.

Our study has important limitations. Our sample was of hospitalists and therefore may not be reflective of other medical specialties. Second, due to the nature of the study design, the responses to spending on defensive medicine may not represent actual practice. Third, we did not confirm details such as place of employment or history of lawsuit, and this may be subject to recall bias. However, physicians are unlikely to forget having been sued. Finally, this survey is observational and cross-sectional. Our data imply association rather than causation. Without longitudinal data, it is impossible to know if years of practice correlate with perceived defensive medicine spending due to a generational effect or a longitudinal effect (such as more confidence in diagnostic skills with more years of practice).

Despite these limitations, our survey has important policy implications. First, we found that defensive medicine is perceived by hospitalists to be costly. Although physicians likely overestimated the cost (37.5%, or an estimated $1 trillion is far higher than previous estimates of approximately 2% of all healthcare spending),⁴ it also demonstrates the extent to which physicians feel as though the medical care that is provided may be unnecessary. Second, at least a quarter of hospitalist physicians have been sued, and the risk of being named as a defendant in a lawsuit increases the longer they have been in clinical practice.

Given these findings, policies aimed to reduce the practice of defensive medicine may help the rising costs of healthcare. Reducing defensive medicine requires decreasing physician fears of liability and related reporting. Traditional tort reforms (with the exception of damage caps) have not been proven to do this. And damage caps can be inequitable, hard to pass, and even found to be unconstitutional in some states.¹³ However, other reform options hold promise in reducing liability fears, including enterprise liability, safe harbor legislation, and health courts.¹³ Finally, shared decision-making models may also provide a method to reduce defensive fears as well.⁶

Acknowledgments

The authors thank the Society of Hospital Medicine, Dr. Scott Flanders, Andrew Hickner, and David Ratz for their assistance with this project.

Disclosure

The authors received financial support from the Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs Health Services Research and Development Center for Clinical Management Research, the University of Michigan Specialist-Hospitalist Allied Research Program, and the Ann Arbor University of Michigan VA Patient Safety Enhancement Program.

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs, or the Society of Hospital Medicine.

Annual healthcare costs in the United States are over $3 trillion and are garnering significant national attention.¹ The United States spends approximately 2.5 times more per capita on healthcare when compared to other developed nations.² One source of unnecessary cost in healthcare is defensive medicine. Defensive medicine has been defined by Congress as occurring “when doctors order tests, procedures, or visits, or avoid certain high-risk patients or procedures, primarily (but not necessarily) because of concern about malpractice liability.”³

Though difficult to assess, in 1 study, defensive medicine was estimated to cost $45 billion annually.⁴ While general agreement exists that physicians practice defensive medicine, the extent of defensive practices and the subsequent impact on healthcare costs remain unclear. This is especially true for a group of clinicians that is rapidly increasing in number: hospitalists. Currently, there are more than 50,000 hospitalists in the United States,⁵ yet the prevalence of defensive medicine in this relatively new specialty is unknown. Inpatient care is complex and time constraints can impede establishing an optimal therapeutic relationship with the patient, potentially raising liability fears. We therefore sought to quantify hospitalist physician estimates of the cost of defensive medicine and assess correlates of their estimates. As being sued might spur defensive behaviors, we also assessed how many hospitalists reported being sued and whether this was associated with their estimates of defensive medicine.

Survey Questionnaire

In a previously published survey-based analysis, we reported on physician practice and overuse for 2 common scenarios in hospital medicine: preoperative evaluation and management of uncomplicated syncope.⁶ After responding to the vignettes, each physician was asked to provide demographic and employment information and malpractice history. In addition, they were asked the following: In your best estimation, what percentage of healthcare-related resources (eg, hospital admissions, diagnostic testing, treatment) are spent purely because of defensive medicine concerns? __________% resources

Survey Sample & Administration

The survey was sent to a sample of 1753 hospitalists, randomly identified through the Society of Hospital Medicine’s (SHM) database of members and annual meeting attendees. It is estimated that almost 30% of practicing hospitalists in the United States are members of the SHM.⁵ A full description of the sampling methodology was previously published.⁶ Selected hospitalists were mailed surveys, a $20 financial incentive, and subsequent reminders between June and October 2011.

The study was exempted from institutional review board review by the University of Michigan and the VA Ann Arbor Healthcare System.

Variables

The primary outcome of interest was the response to the “% resources” estimated to be spent on defensive medicine. This was analyzed as a continuous variable. Independent variables included the following: VA employment, malpractice insurance payer, employer, history of malpractice lawsuit, sex, race, and years practicing as a physician.

Statistical Analysis

Analyses were conducted using SAS, version 9.4 (SAS Institute). Descriptive statistics were first calculated for all variables. Next, bivariable comparisons between the outcome variables and other variables of interest were performed. Multivariable comparisons were made using linear regression for the outcome of estimated resources spent on defensive medicine. A P value of < 0.05 was considered statistically significant.

Of the 1753 surveys mailed, 253 were excluded due to incorrect addresses or because the recipients were not practicing hospitalists. A total of 1020 were completed and returned, yielding a 68% response rate (1020 out of 1500 eligible). The hospitalist respondents were in practice for an average of 11 years (range 1-40 years). Respondents represented all 50 states and had a diverse background of experience and demographic characteristics, which has been previously described.⁶

Resources Estimated Spent on Defensive Medicine

Hospitalists reported, on average, that they believed defensive medicine accounted for 37.5% (standard deviation, 20.2%) of all healthcare spending. Results from the multivariable regression are presented in the Table. Hospitalists affiliated with a VA hospital reported 5.5% less in resources spent on defensive medicine than those not affiliated with a VA hospital (32.2% VA vs 37.7% non-VA, P = 0.025). For every 10 years in practice, the estimate of resources spent on defensive medicine decreased by 3% (P = 0.003). Those who were male (36.4% male vs 39.4% female, P = 0.023) and non-Hispanic white (32.5% non-Hispanic white vs 44.7% other, P ≤ 0.001) also estimated less resources spent on defensive medicine. We did not find an association between a hospitalist reporting being sued and their perception of resources spent on defensive medicine.  

Risk of Being Sued

Over a quarter of our sample (25.6%) reported having been sued at least once for medical malpractice. The proportion of hospitalists that reported a history of being sued generally increased with more years of practice (Figure). For those who had been in practice for at least 20 years, more than half (55%) had been sued at least once during their career.

In a national survey, hospitalists estimated that almost 40% of all healthcare-related resources are spent purely because of defensive medicine concerns. This estimate was affected by personal demographic and employment factors. Our second major finding is that over one-quarter of a large random sample of hospitalist physicians reported being sued for malpractice.

Hospitalist perceptions of defensive medicine varied significantly based on employment at a VA hospital, with VA-affiliated hospitalists reporting less estimated spending on defensive medicine. This effect may reflect a less litigious environment within the VA, even though physicians practicing within the VA can be reported to the National Practitioner Data Bank.⁷ The different environment may be due to the VA’s patient mix (VA patients tend to be poorer, older, sicker, and have more mental illness)⁸; however, it could also be due to its de facto practice of a form of enterprise liability, in which, by law, the VA assumes responsibility for negligence, sheltering its physicians from direct liability.

We also found that the higher the number of years a hospitalist reported practicing, the lower the perception of resources being spent on defensive medicine. The reason for this finding is unclear. There has been a recent focus on high-value care and overspending, and perhaps younger hospitalists are more aware of these initiatives and thus have higher estimates. Additionally, non-Hispanic white male respondents estimated a lower amount spent on defensive medicine compared with other respondents. This is consistent with previous studies of risk perception which have noted a “white male effect” in which white males generally perceive a wide range of risks to be lower than female and non-white individuals, likely due to sociopolitical factors.⁹ Here, the white male effect is particularly interesting, considering that male physicians are almost 2.5 times as likely as female physicians to report being sued.¹⁰

Similar to prior studies,¹¹ there was no association with personal liability claim experience and perceived resources spent on defensive medicine. It is unclear why personal experience of being sued does not appear to be associated with perceptions of defensive medicine practice. It is possible that the fear of being sued is worse than the actual experience or that physicians believe that lawsuits are either random events or inevitable and, as a result, do not change their practice patterns.

The lifetime risk of being named in a malpractice suit is substantial for hospitalists: in our study, over half of hospitalists in practice for 20 years or more reported they had been sued. This corresponds with the projection made by Jena and colleagues,¹² which estimated that 55% of internal medicine physicians will be sued by the age of 45, a number just slightly higher than the average for all physicians.

Our study has important limitations. Our sample was of hospitalists and therefore may not be reflective of other medical specialties. Second, due to the nature of the study design, the responses to spending on defensive medicine may not represent actual practice. Third, we did not confirm details such as place of employment or history of lawsuit, and this may be subject to recall bias. However, physicians are unlikely to forget having been sued. Finally, this survey is observational and cross-sectional. Our data imply association rather than causation. Without longitudinal data, it is impossible to know if years of practice correlate with perceived defensive medicine spending due to a generational effect or a longitudinal effect (such as more confidence in diagnostic skills with more years of practice).

Despite these limitations, our survey has important policy implications. First, we found that defensive medicine is perceived by hospitalists to be costly. Although physicians likely overestimated the cost (37.5%, or an estimated $1 trillion is far higher than previous estimates of approximately 2% of all healthcare spending),⁴ it also demonstrates the extent to which physicians feel as though the medical care that is provided may be unnecessary. Second, at least a quarter of hospitalist physicians have been sued, and the risk of being named as a defendant in a lawsuit increases the longer they have been in clinical practice.

Given these findings, policies aimed to reduce the practice of defensive medicine may help the rising costs of healthcare. Reducing defensive medicine requires decreasing physician fears of liability and related reporting. Traditional tort reforms (with the exception of damage caps) have not been proven to do this. And damage caps can be inequitable, hard to pass, and even found to be unconstitutional in some states.¹³ However, other reform options hold promise in reducing liability fears, including enterprise liability, safe harbor legislation, and health courts.¹³ Finally, shared decision-making models may also provide a method to reduce defensive fears as well.⁶

Acknowledgments

The authors thank the Society of Hospital Medicine, Dr. Scott Flanders, Andrew Hickner, and David Ratz for their assistance with this project.

Disclosure

The authors received financial support from the Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs Health Services Research and Development Center for Clinical Management Research, the University of Michigan Specialist-Hospitalist Allied Research Program, and the Ann Arbor University of Michigan VA Patient Safety Enhancement Program.

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs, or the Society of Hospital Medicine.

Annual healthcare costs in the United States are over $3 trillion and are garnering significant national attention.¹ The United States spends approximately 2.5 times more per capita on healthcare when compared to other developed nations.² One source of unnecessary cost in healthcare is defensive medicine. Defensive medicine has been defined by Congress as occurring “when doctors order tests, procedures, or visits, or avoid certain high-risk patients or procedures, primarily (but not necessarily) because of concern about malpractice liability.”³

Though difficult to assess, in 1 study, defensive medicine was estimated to cost $45 billion annually.⁴ While general agreement exists that physicians practice defensive medicine, the extent of defensive practices and the subsequent impact on healthcare costs remain unclear. This is especially true for a group of clinicians that is rapidly increasing in number: hospitalists. Currently, there are more than 50,000 hospitalists in the United States,⁵ yet the prevalence of defensive medicine in this relatively new specialty is unknown. Inpatient care is complex and time constraints can impede establishing an optimal therapeutic relationship with the patient, potentially raising liability fears. We therefore sought to quantify hospitalist physician estimates of the cost of defensive medicine and assess correlates of their estimates. As being sued might spur defensive behaviors, we also assessed how many hospitalists reported being sued and whether this was associated with their estimates of defensive medicine.

Survey Questionnaire

In a previously published survey-based analysis, we reported on physician practice and overuse for 2 common scenarios in hospital medicine: preoperative evaluation and management of uncomplicated syncope.⁶ After responding to the vignettes, each physician was asked to provide demographic and employment information and malpractice history. In addition, they were asked the following: In your best estimation, what percentage of healthcare-related resources (eg, hospital admissions, diagnostic testing, treatment) are spent purely because of defensive medicine concerns? __________% resources

Survey Sample & Administration

The survey was sent to a sample of 1753 hospitalists, randomly identified through the Society of Hospital Medicine’s (SHM) database of members and annual meeting attendees. It is estimated that almost 30% of practicing hospitalists in the United States are members of the SHM.⁵ A full description of the sampling methodology was previously published.⁶ Selected hospitalists were mailed surveys, a $20 financial incentive, and subsequent reminders between June and October 2011.

The study was exempted from institutional review board review by the University of Michigan and the VA Ann Arbor Healthcare System.

Variables

The primary outcome of interest was the response to the “% resources” estimated to be spent on defensive medicine. This was analyzed as a continuous variable. Independent variables included the following: VA employment, malpractice insurance payer, employer, history of malpractice lawsuit, sex, race, and years practicing as a physician.

Statistical Analysis

Analyses were conducted using SAS, version 9.4 (SAS Institute). Descriptive statistics were first calculated for all variables. Next, bivariable comparisons between the outcome variables and other variables of interest were performed. Multivariable comparisons were made using linear regression for the outcome of estimated resources spent on defensive medicine. A P value of < 0.05 was considered statistically significant.

Of the 1753 surveys mailed, 253 were excluded due to incorrect addresses or because the recipients were not practicing hospitalists. A total of 1020 were completed and returned, yielding a 68% response rate (1020 out of 1500 eligible). The hospitalist respondents were in practice for an average of 11 years (range 1-40 years). Respondents represented all 50 states and had a diverse background of experience and demographic characteristics, which has been previously described.⁶

Resources Estimated Spent on Defensive Medicine

Hospitalists reported, on average, that they believed defensive medicine accounted for 37.5% (standard deviation, 20.2%) of all healthcare spending. Results from the multivariable regression are presented in the Table. Hospitalists affiliated with a VA hospital reported 5.5% less in resources spent on defensive medicine than those not affiliated with a VA hospital (32.2% VA vs 37.7% non-VA, P = 0.025). For every 10 years in practice, the estimate of resources spent on defensive medicine decreased by 3% (P = 0.003). Those who were male (36.4% male vs 39.4% female, P = 0.023) and non-Hispanic white (32.5% non-Hispanic white vs 44.7% other, P ≤ 0.001) also estimated less resources spent on defensive medicine. We did not find an association between a hospitalist reporting being sued and their perception of resources spent on defensive medicine.  

Risk of Being Sued

Over a quarter of our sample (25.6%) reported having been sued at least once for medical malpractice. The proportion of hospitalists that reported a history of being sued generally increased with more years of practice (Figure). For those who had been in practice for at least 20 years, more than half (55%) had been sued at least once during their career.

In a national survey, hospitalists estimated that almost 40% of all healthcare-related resources are spent purely because of defensive medicine concerns. This estimate was affected by personal demographic and employment factors. Our second major finding is that over one-quarter of a large random sample of hospitalist physicians reported being sued for malpractice.

Hospitalist perceptions of defensive medicine varied significantly based on employment at a VA hospital, with VA-affiliated hospitalists reporting less estimated spending on defensive medicine. This effect may reflect a less litigious environment within the VA, even though physicians practicing within the VA can be reported to the National Practitioner Data Bank.⁷ The different environment may be due to the VA’s patient mix (VA patients tend to be poorer, older, sicker, and have more mental illness)⁸; however, it could also be due to its de facto practice of a form of enterprise liability, in which, by law, the VA assumes responsibility for negligence, sheltering its physicians from direct liability.

We also found that the higher the number of years a hospitalist reported practicing, the lower the perception of resources being spent on defensive medicine. The reason for this finding is unclear. There has been a recent focus on high-value care and overspending, and perhaps younger hospitalists are more aware of these initiatives and thus have higher estimates. Additionally, non-Hispanic white male respondents estimated a lower amount spent on defensive medicine compared with other respondents. This is consistent with previous studies of risk perception which have noted a “white male effect” in which white males generally perceive a wide range of risks to be lower than female and non-white individuals, likely due to sociopolitical factors.⁹ Here, the white male effect is particularly interesting, considering that male physicians are almost 2.5 times as likely as female physicians to report being sued.¹⁰

Similar to prior studies,¹¹ there was no association with personal liability claim experience and perceived resources spent on defensive medicine. It is unclear why personal experience of being sued does not appear to be associated with perceptions of defensive medicine practice. It is possible that the fear of being sued is worse than the actual experience or that physicians believe that lawsuits are either random events or inevitable and, as a result, do not change their practice patterns.

The lifetime risk of being named in a malpractice suit is substantial for hospitalists: in our study, over half of hospitalists in practice for 20 years or more reported they had been sued. This corresponds with the projection made by Jena and colleagues,¹² which estimated that 55% of internal medicine physicians will be sued by the age of 45, a number just slightly higher than the average for all physicians.

Our study has important limitations. Our sample was of hospitalists and therefore may not be reflective of other medical specialties. Second, due to the nature of the study design, the responses to spending on defensive medicine may not represent actual practice. Third, we did not confirm details such as place of employment or history of lawsuit, and this may be subject to recall bias. However, physicians are unlikely to forget having been sued. Finally, this survey is observational and cross-sectional. Our data imply association rather than causation. Without longitudinal data, it is impossible to know if years of practice correlate with perceived defensive medicine spending due to a generational effect or a longitudinal effect (such as more confidence in diagnostic skills with more years of practice).

Despite these limitations, our survey has important policy implications. First, we found that defensive medicine is perceived by hospitalists to be costly. Although physicians likely overestimated the cost (37.5%, or an estimated $1 trillion is far higher than previous estimates of approximately 2% of all healthcare spending),⁴ it also demonstrates the extent to which physicians feel as though the medical care that is provided may be unnecessary. Second, at least a quarter of hospitalist physicians have been sued, and the risk of being named as a defendant in a lawsuit increases the longer they have been in clinical practice.

Given these findings, policies aimed to reduce the practice of defensive medicine may help the rising costs of healthcare. Reducing defensive medicine requires decreasing physician fears of liability and related reporting. Traditional tort reforms (with the exception of damage caps) have not been proven to do this. And damage caps can be inequitable, hard to pass, and even found to be unconstitutional in some states.¹³ However, other reform options hold promise in reducing liability fears, including enterprise liability, safe harbor legislation, and health courts.¹³ Finally, shared decision-making models may also provide a method to reduce defensive fears as well.⁶

Acknowledgments

The authors thank the Society of Hospital Medicine, Dr. Scott Flanders, Andrew Hickner, and David Ratz for their assistance with this project.

Disclosure

The authors received financial support from the Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs Health Services Research and Development Center for Clinical Management Research, the University of Michigan Specialist-Hospitalist Allied Research Program, and the Ann Arbor University of Michigan VA Patient Safety Enhancement Program.

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs, or the Society of Hospital Medicine.

Patient satisfaction with medical care during hospitalization is a common quality metric.^1,2 Studies showing higher patient satisfaction have reported lower 30-day hospital readmissions³ and improved overall health.^4,5 Conversely, communication failures are associated with dissatisfaction among hospitalized patients and adverse outcomes.^6,7 A lack of familiarity with hospital providers weakens collaborative decision making and prevents high-quality patient care.^8,9

Bedside visual tools, such as whiteboards and pictures of medical staff, have been widely used to enhance communication between patients, families, and providers.^10,11 Results of studies evaluating these tools are varied. For example, 1 study found that 98% of patients were better able to identify physicians when their names were written on whiteboards.¹² Yet in another, only 21.1% of patients were more likely to correctly identify ≥1 physicians using pictures.¹³ Thus, despite widespread use,¹¹ whether visual tools improve patient satisfaction and patient care more broadly remains unclear.^14,15

We performed a systematic review to answer the following 3 questions: first, what is the effect of visual tools on outcomes (ie, provider identification, understanding of providers’ roles, patient–provider communication, and satisfaction); second, does impact vary by type of visual tool (eg, whiteboards vs pictures of providers); and third, what factors (eg, study design, patient population) are associated with provider identification, communication, and patient satisfaction?

Search Strategy

We used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis when performing this review.¹⁶ A research librarian (WT) conducted serial searches for studies reporting the use of bedside visual tools for hospitalized patients in Medline (via OVID), Embase, SCOPUS, Web of Science, CINAHL, and Cochrane DSR and CENTRAL. Controlled vocabularies (ie, Medical Subject Headings terms) were used to identify synonyms for visual tools of interest. Additional studies were identified manually through bibliographies and meeting abstracts. No study design, publication date, or language restrictions were placed on the search, which was conducted between April 2016 and February 2017 (see supplementary Appendix A).

Study Selection

Two reviewers (AG and KT) independently assessed study eligibility; discrepancies were resolved by a third reviewer (VC). We included all adult or pediatric English language studies in which the effect of visual tool(s) on patient outcomes was reported. Visual tools were defined as the bedside display of information or an instrument given to patients to convey information regarding providers or medical care. Patient-reported outcomes included the following: (a) physician identification, (b) understanding of provider roles, (c) patient–provider communication, and (d) patient satisfaction with care. Providers were defined as physicians, residents, interns, medical students, nurse practitioners, or nurses. We excluded studies that were not original research (eg, conference abstracts, not peer reviewed), reported qualitative data without quantitative outcomes, or did not include a bedside visual tool. Given our interest in hospitalized general medicine patients, studies conducted in emergency departments, surgical units, obstetrics and gynecology wards, and intensive care units were excluded.

Data Extraction and Analysis

Data were extracted independently and in duplicate from all studies by using a template adapted from the Cochrane Collaboration.¹⁷ For all studies, we abstracted study design, type of visual tool (eg, whiteboards), unit setting (eg, medical), population studied (eg, adult vs pediatric), and outcomes reported (ie, physician identification, understanding of provider roles, communication, and satisfaction with care). Reviewers independently assessed and categorized the impact of tools on reported outcomes.

To standardize and compare outcomes across studies, the following were used to denote a positive association between visual tools and relevant outcomes: a greater number of physicians correctly identified by name/picture or title/role; the use of terms such as “high,” “agreed,” or “significant” on surveys; or ≥4 Likert scores for domains of identification, understanding of roles, communication, and satisfaction with care. Conversely, the inability to identify providers compared to the control/baseline; poor recall of titles/roles; lower Likert-scale scores (ie, ≤2); or survey terms such as “poor,” “disagreed,” or “insignificant” were considered to connote negative impact. Studies in which Likert scores were rated neither high nor low (ie, 3), or in which patients neither agreed nor disagreed on value were considered neutral.

Owing to clinical heterogeneity within studies, meta-analyses were not performed. Descriptive statistics were used to describe study outcomes. A priori¹⁸ studies were evaluated according to the following categories: design (eg, randomized vs observational), outcomes (eg, patient satisfaction), intervention (type of visual tool), and patient population (adult or pediatric). Because pediatric patients have underdeveloped communication skills and include parents and/or guardians, data from pediatric studies were tabulated and reported separately to those from adult studies.

Quality Assessment

As recommended by the Cochrane Collaboration, 2 reviewers (AG, KT) assessed the risk of study bias by using the Downs and Black Scale.^17,19 Discrepancies in assessment were resolved by a third reviewer (VC). This instrument uses a point-based system to estimate the quality of a study by rating domains such as internal and external validity, bias, and confounding. In keeping with prior systematic reviews,^18,20,21 studies with a score of ≥18 were considered high quality. Interrater agreement for the adjudication of study quality was calculated using the Cohen κ statistic.

Eleven studies were conducted on adult hospitalized pa­tients ^{12-14,22-24,26,27,29,30,33} and included 3 randomized controlled studies.^14,27,33

Results by Outcomes Provider Identification Nine studies measured patients’ ability to identify providers with the use of visual aids, and all 9 reported improvements in this outcome. Visual tools used to measure provider identification included pictures (n = 5),^{13,14,23,27,33} whiteboards (n = 3),^12,22,30 and patient portals (n = 1).²⁶ Within studies that used pictures, individual pictures (n = 2)^13,23 and handouts with pictures of multiple providers (n = 3) were used.^14,27,33 In 2 studies, care team members such as a dietitian, physiotherapist or pharmacist, were included when measuring identification.^14,33

Understanding Providers’ RolesSix studies assessed the effect of visual tools on patients’ understanding of provider roles.^{13,14,22,26,27,33} Four studies reported a positive effect with the use of pictures,^27,33 whiteboards,²² and patient portals.²⁶ However, 2 studies reported either no difference or negative impressions. Appel et al.¹⁴ reported no difference in the understanding of physician roles using a handout of providers’ pictures and titles. Arora et al.¹³ used individual pictures of physicians with descriptions of roles and found a negative association, as demonstrated by fewer patients rating their understanding of physicians’ roles as excellent or very good in the intervention period (45.6%) compared with the baseline (55.3%).

 

Patient–Provider Communication

Three studies evaluated the influence of visual tools on communication.^14,24,29 Using pictures, Appel et al.¹⁴ found no difference in the perceived quality of communication. Singh et al.²⁹ used whiteboards and reported improved communication scores for physicians and nurses. With notepads, patients surveyed by Farberg et al.²⁴ stated that the tool improved provider communication.

Patient Satisfaction

Five studies assessed patient satisfaction related to the use of visual tools. ^{22,23,27,30,33} One study reported satisfaction as positive with the use of individual pictures.²³ Two studies that used handouts with pictures of all team members reported either a positive³³ or neutral²⁷ impact on satisfaction. Studies that used whiteboards reported a positive association with satisfaction^22,30 despite differences in content, such as the inclusion of prewritten prompts for writing goals of care and scheduled tests³⁰ versus the name of the nurse and their education level.²²

Results by Type of Visual Tool Pictures

Five studies that used pictures reported a positive effect on provider identification.^{13,14,23,27,33} Two^27,33 of 4 studies^13,14,27,33 that assessed patients’ understanding of team member roles reported a positive influence, while 1 reported no difference.¹⁴ A fourth study demonstrated a negative association, perhaps due to differences in the description of providers’ roles listed on the tool.¹³ Only 1 study examined the influence of pictures on patient–provider communication, and this study found no difference.¹⁴ Satisfaction with care via the use of pictures varied between positive (2 studies)^23,33 and neutral (1 study).²⁷

Whiteboards

Four studies tested the use of whiteboards; of these, 3 reported a positive influence on provider identification.^12,22,30 One study reported a positive impact on patient–provider communication.²⁹ Two studies noted a positive effect on patient satisfaction.^22,30 Notably, the responsibility for updating whiteboards differed between the studies (ie, nurses only²² vs residents, medical students, and nurses).³⁰

Patient Portal

In 1 study, an electronic portal that included names with pictures of providers, descriptions of their roles, lists of medications, and scheduled tests and/or procedures was used as a visual tool. The portal improved patients’ identification of physicians and patients’ understanding of roles. However, improvements in the knowledge of medication changes and planned tests and/or procedures during hospitalization were not observed.²⁶ This finding would suggest limitations in the hospitalized patient’s knowledge of the plan of care, which could potentially weaken patient–provider communication.

Notepads

Only 1 study assessed the use of formatted notepads on patient–provider communication and noted a positive association. Notepads used prompts for different categories (eg, diagnosis/treatment, medications, etc) to encourage patient questions for providers.²⁴

Five studies were conducted on hospitalized pediatric units.^{15,25,28,31,32} All studies surveyed the parents, guardians, or caregivers of pediatric patients. One study excluded patients ≥12 years of age because of legal differences in access to adolescent health information,³² while another interviewed parents and/or guardians of teenagers.¹⁵

Results by Outcomes Provider Identification and Understanding of Physicians’ Roles

Four studies that assessed the influence of visual tools on provider identification and understanding of roles reported a positive association.^15,25,28,31 Visual tools varied between pictures (n = 2),^15,31 patient portal (n = 1),²⁸ and whiteboards and pictures combined (n = 1).²⁵ The measurement of outcomes varied between surveys with free text responses,²⁸ multiple choice questions,²⁵ and 1-5 Likert scales.^15,31

Patient–Provider Communication

Two studies assessed the impact of patient portal use on communication and reported a positive association.^28,32 The 2 portals autopopulated names, pictures, and roles of providers from electronic medical records. Singh et al.²⁸ used a portal that was also available in Spanish and accommodated for non-English speakers. Kelly et al.³² reported that 90% of parents perceived that portal use was associated with reduced errors in care, with 8% finding errors in their child’s medication list.

Patient Satisfaction

Three studies assessed patient satisfaction via the use of visual tools.^15,28,31 Singh et al.²⁸ noted a positive influence on satisfaction via a patient portal. Dudas et al.¹⁵ used a single-page handout with names and pictures of each provider, along with information regarding the training and roles of each provider. Distribution of these handouts to patients by investigators led to a positive influence on satisfaction. While Unaka et al.³¹ used a similar handout, they asked residents to distribute them and found no significant difference in satisfaction scores between the intervention (66%) and control group (62%).

Results by Type of Visual Tool Pictures

Two studies reported a positive impact on provider identification and understanding of roles with the use of pictures.^15,31 Dudas et al.¹⁵ demonstrated a 4.8-fold increase in the odds of parents identifying a medical student, as compared with the control. Similarly, after adjusting for length of stay and prior hospitalization, Unaka et al.³¹ reported that a higher percentage of patients correctly identified providers using this approach.

Whiteboard and Picture

One study evaluated the simultaneous use of whiteboards and pictures to improve the identification of providers. The study noted improved identification of supervising doctors and increased recognition of roles for supervising doctors, residents, and medical students.²⁵

Patient Portal

Two studies used patient portals as visual tools. Singh et al.²⁸ assessed the use of a patient portal with names, roles, and pictures of treatment team members. Use of this tool was positively associated with provider identification, understanding of roles, communication, and satisfaction. Kelly et al.³² noted that 60% of parents felt that portal use improved healthcare team communication.

The risk of bias was assessed for both adult and pediatric studies in aggregate. The average risk of bias using the Downs and Black Scale was 17.81 (range 14-22, standard deviation [SD] 2.20). Of the 16 included studies, 9 were rated at a low risk of bias (score

• >

18).^13-15,26-31 Risk of bias was greatest for measures of external validity (mean 2.88, range 2-3, SD 0.34), internal validity (mean 4.06, range 3-6, SD 1.00), and confounding (mean 2.69, range 1-6, SD 1.35). Two of 3 randomized controlled trials had a low risk of bias.^14,27 Interrater reliability for study quality adjudication was 0.90, suggesting excellent agreement (see supplementary Appendix B).

In this systematic review, the effects of visual tools on outcomes, such as provider identification, understanding of roles, patient–provider communication, and satisfaction with care, were variable. The majority of included studies were conducted on adult patients (n = 11).^{12-14,22-24,26,27,29,30,33} Pictures were the most frequently used tool (n = 7)^{13-15,23,27,31,33} and consequently had the greatest sample size across the review (n = 1297). While pictures had a positive influence on provider identification in all studies, comprehension of provider roles and satisfaction were variable. Although the content of whiteboards varied between studies, they showed favorable effects on provider identification (3 of 4 studies)^12,22,30 and satisfaction (2 of 2 studies).^22,30 While electronic medical record-based tools had a positive influence on outcomes,^26,28 only 1 accounted for language preferences.²⁸ Formatted notepads positively influenced patient–provider communication, but their use was limited by literacy.²⁴ Collectively, these data suggest that visual tools have varying effects on patient-reported outcomes, likely owing to differences in study design, interventions, and evaluation methods.

Theoretically, visual tools should facilitate easier identification of providers and engender collaborative relationships. However, such tools do not replace face-to-face patient–provider and family discussions. Rather, these enhancements best serve as a medium to asynchronously display information to patients and family members. Indeed, within the included studies, we found that the use of visual tools was effective in improving satisfaction (6/8 studies), identification (13/13 studies), and understanding of provider roles (8/10 studies). Thus, it is reasonable to say that, in conjunction with excellent clinical care, these tools have an important role in improving care delivery in the hospital.

Despite this promise, we noted that the effectiveness of individual tools varied, a fact that may relate to differences across studies. First, inconsistencies in the format and/or content of the tools were noted. For example, within studies using pictures, tools varied from individual photographs of each team member^13,23 to 1-page handouts with pictures of all team members.^14,15,31 Such differences in presentation could affect spatial recognition in identifying providers, as single photos are known to be easier to process than multiple images at the same time.³⁴ Second, no study evaluated patient preference of a visual tool. Thus, personal preferences for pictures versus whiteboards versus electronic modalities or a combination of tools might affect outcomes. Additionally, the utility of visual tools in visually impaired, confused, or non-English-speaking patients may limit effectiveness. Future studies that address these aspects and account for patient preferences may better elucidate the role of visual tools in hospitals.

Our results should be considered in the context of several limitations. First, only 3 studies used randomized trial designs; thus, confounding from unmeasured variables inherent to observational designs is possible. Second, none of the interventions tested were blinded to providers, raising the possibility of a Hawthorne effect (ie, alteration of provider behavior in response to awareness of being observed).³⁵ Third, all studies were conducted at single centers, and only 9 of 16 studies were rated at a low risk of bias; thus, caution in broad extrapolations of this literature is necessary.

However, our study has several strengths, including a thorough search of heterogeneous literature, inclusion of both adult and pediatric populations, and a focus on myriad patient-reported outcomes. Second, by contrasting outcomes and measurement strategies across studies, our review helps explicate differences in results related to variation in outcome measurement or presentation of visual data. Third, because we frame results by outcome and type of visual tool used, we are able to identify strengths and weaknesses of individual tools in novel ways. Finally, our data suggest that the use of picture-based techniques and whiteboards are among the most promising visual interventions. Future studies that pair graphic designers with patients to improve the layout of these tools might prove valuable. Additionally, because the measurement of outcomes is confounded by aspects such as lack of controls, severity of illness, and language barriers, a randomized design would help provide greater clarity regarding effectiveness.

In conclusion, we found that visual tools appear to foster recognition of providers and understanding of their roles. However, variability of format, content, and measurement of outcomes hinders the identification of a single optimal approach. Future work using randomized controlled trial designs and standardized tools and measurements would be welcomed.

Acknowledgments

The authors thank Laura Appel, Kevin O’Leary, and Siddharth Singh for providing unpublished data and clarifications to help these analyses.

Disclosure

 Anupama Goyal is the guarantor. Anupama Goyal and Komalpreet Tur performed primary data abstraction and analysis. Anupama Goyal, Scott Flanders, Jason Mann, and Vineet Chopra drafted the manuscript. All authors contributed to the development of the selection criteria, the risk of bias assessment strategy, and the data extraction criteria. Anupama Goyal, Jason Mann, Whitney Townsend, and Vineet Chopra developed the search strategy. Vineet Chopra provided systematic review expertise. All authors read, provided feedback, and approved the final manuscript. The authors declare that they have no conflicts of interest.

Patient satisfaction with medical care during hospitalization is a common quality metric.^1,2 Studies showing higher patient satisfaction have reported lower 30-day hospital readmissions³ and improved overall health.^4,5 Conversely, communication failures are associated with dissatisfaction among hospitalized patients and adverse outcomes.^6,7 A lack of familiarity with hospital providers weakens collaborative decision making and prevents high-quality patient care.^8,9

Bedside visual tools, such as whiteboards and pictures of medical staff, have been widely used to enhance communication between patients, families, and providers.^10,11 Results of studies evaluating these tools are varied. For example, 1 study found that 98% of patients were better able to identify physicians when their names were written on whiteboards.¹² Yet in another, only 21.1% of patients were more likely to correctly identify ≥1 physicians using pictures.¹³ Thus, despite widespread use,¹¹ whether visual tools improve patient satisfaction and patient care more broadly remains unclear.^14,15

We performed a systematic review to answer the following 3 questions: first, what is the effect of visual tools on outcomes (ie, provider identification, understanding of providers’ roles, patient–provider communication, and satisfaction); second, does impact vary by type of visual tool (eg, whiteboards vs pictures of providers); and third, what factors (eg, study design, patient population) are associated with provider identification, communication, and patient satisfaction?

Search Strategy

We used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis when performing this review.¹⁶ A research librarian (WT) conducted serial searches for studies reporting the use of bedside visual tools for hospitalized patients in Medline (via OVID), Embase, SCOPUS, Web of Science, CINAHL, and Cochrane DSR and CENTRAL. Controlled vocabularies (ie, Medical Subject Headings terms) were used to identify synonyms for visual tools of interest. Additional studies were identified manually through bibliographies and meeting abstracts. No study design, publication date, or language restrictions were placed on the search, which was conducted between April 2016 and February 2017 (see supplementary Appendix A).

Study Selection

Two reviewers (AG and KT) independently assessed study eligibility; discrepancies were resolved by a third reviewer (VC). We included all adult or pediatric English language studies in which the effect of visual tool(s) on patient outcomes was reported. Visual tools were defined as the bedside display of information or an instrument given to patients to convey information regarding providers or medical care. Patient-reported outcomes included the following: (a) physician identification, (b) understanding of provider roles, (c) patient–provider communication, and (d) patient satisfaction with care. Providers were defined as physicians, residents, interns, medical students, nurse practitioners, or nurses. We excluded studies that were not original research (eg, conference abstracts, not peer reviewed), reported qualitative data without quantitative outcomes, or did not include a bedside visual tool. Given our interest in hospitalized general medicine patients, studies conducted in emergency departments, surgical units, obstetrics and gynecology wards, and intensive care units were excluded.

Data Extraction and Analysis

Data were extracted independently and in duplicate from all studies by using a template adapted from the Cochrane Collaboration.¹⁷ For all studies, we abstracted study design, type of visual tool (eg, whiteboards), unit setting (eg, medical), population studied (eg, adult vs pediatric), and outcomes reported (ie, physician identification, understanding of provider roles, communication, and satisfaction with care). Reviewers independently assessed and categorized the impact of tools on reported outcomes.

To standardize and compare outcomes across studies, the following were used to denote a positive association between visual tools and relevant outcomes: a greater number of physicians correctly identified by name/picture or title/role; the use of terms such as “high,” “agreed,” or “significant” on surveys; or ≥4 Likert scores for domains of identification, understanding of roles, communication, and satisfaction with care. Conversely, the inability to identify providers compared to the control/baseline; poor recall of titles/roles; lower Likert-scale scores (ie, ≤2); or survey terms such as “poor,” “disagreed,” or “insignificant” were considered to connote negative impact. Studies in which Likert scores were rated neither high nor low (ie, 3), or in which patients neither agreed nor disagreed on value were considered neutral.

Owing to clinical heterogeneity within studies, meta-analyses were not performed. Descriptive statistics were used to describe study outcomes. A priori¹⁸ studies were evaluated according to the following categories: design (eg, randomized vs observational), outcomes (eg, patient satisfaction), intervention (type of visual tool), and patient population (adult or pediatric). Because pediatric patients have underdeveloped communication skills and include parents and/or guardians, data from pediatric studies were tabulated and reported separately to those from adult studies.

Quality Assessment

As recommended by the Cochrane Collaboration, 2 reviewers (AG, KT) assessed the risk of study bias by using the Downs and Black Scale.^17,19 Discrepancies in assessment were resolved by a third reviewer (VC). This instrument uses a point-based system to estimate the quality of a study by rating domains such as internal and external validity, bias, and confounding. In keeping with prior systematic reviews,^18,20,21 studies with a score of ≥18 were considered high quality. Interrater agreement for the adjudication of study quality was calculated using the Cohen κ statistic.

Eleven studies were conducted on adult hospitalized pa­tients ^{12-14,22-24,26,27,29,30,33} and included 3 randomized controlled studies.^14,27,33

Results by Outcomes Provider Identification Nine studies measured patients’ ability to identify providers with the use of visual aids, and all 9 reported improvements in this outcome. Visual tools used to measure provider identification included pictures (n = 5),^{13,14,23,27,33} whiteboards (n = 3),^12,22,30 and patient portals (n = 1).²⁶ Within studies that used pictures, individual pictures (n = 2)^13,23 and handouts with pictures of multiple providers (n = 3) were used.^14,27,33 In 2 studies, care team members such as a dietitian, physiotherapist or pharmacist, were included when measuring identification.^14,33

Understanding Providers’ RolesSix studies assessed the effect of visual tools on patients’ understanding of provider roles.^{13,14,22,26,27,33} Four studies reported a positive effect with the use of pictures,^27,33 whiteboards,²² and patient portals.²⁶ However, 2 studies reported either no difference or negative impressions. Appel et al.¹⁴ reported no difference in the understanding of physician roles using a handout of providers’ pictures and titles. Arora et al.¹³ used individual pictures of physicians with descriptions of roles and found a negative association, as demonstrated by fewer patients rating their understanding of physicians’ roles as excellent or very good in the intervention period (45.6%) compared with the baseline (55.3%).

 

Patient–Provider Communication

Three studies evaluated the influence of visual tools on communication.^14,24,29 Using pictures, Appel et al.¹⁴ found no difference in the perceived quality of communication. Singh et al.²⁹ used whiteboards and reported improved communication scores for physicians and nurses. With notepads, patients surveyed by Farberg et al.²⁴ stated that the tool improved provider communication.

Patient Satisfaction

Five studies assessed patient satisfaction related to the use of visual tools. ^{22,23,27,30,33} One study reported satisfaction as positive with the use of individual pictures.²³ Two studies that used handouts with pictures of all team members reported either a positive³³ or neutral²⁷ impact on satisfaction. Studies that used whiteboards reported a positive association with satisfaction^22,30 despite differences in content, such as the inclusion of prewritten prompts for writing goals of care and scheduled tests³⁰ versus the name of the nurse and their education level.²²

Results by Type of Visual Tool Pictures

Five studies that used pictures reported a positive effect on provider identification.^{13,14,23,27,33} Two^27,33 of 4 studies^13,14,27,33 that assessed patients’ understanding of team member roles reported a positive influence, while 1 reported no difference.¹⁴ A fourth study demonstrated a negative association, perhaps due to differences in the description of providers’ roles listed on the tool.¹³ Only 1 study examined the influence of pictures on patient–provider communication, and this study found no difference.¹⁴ Satisfaction with care via the use of pictures varied between positive (2 studies)^23,33 and neutral (1 study).²⁷

Whiteboards

Four studies tested the use of whiteboards; of these, 3 reported a positive influence on provider identification.^12,22,30 One study reported a positive impact on patient–provider communication.²⁹ Two studies noted a positive effect on patient satisfaction.^22,30 Notably, the responsibility for updating whiteboards differed between the studies (ie, nurses only²² vs residents, medical students, and nurses).³⁰

Patient Portal

In 1 study, an electronic portal that included names with pictures of providers, descriptions of their roles, lists of medications, and scheduled tests and/or procedures was used as a visual tool. The portal improved patients’ identification of physicians and patients’ understanding of roles. However, improvements in the knowledge of medication changes and planned tests and/or procedures during hospitalization were not observed.²⁶ This finding would suggest limitations in the hospitalized patient’s knowledge of the plan of care, which could potentially weaken patient–provider communication.

Notepads

Only 1 study assessed the use of formatted notepads on patient–provider communication and noted a positive association. Notepads used prompts for different categories (eg, diagnosis/treatment, medications, etc) to encourage patient questions for providers.²⁴

Five studies were conducted on hospitalized pediatric units.^{15,25,28,31,32} All studies surveyed the parents, guardians, or caregivers of pediatric patients. One study excluded patients ≥12 years of age because of legal differences in access to adolescent health information,³² while another interviewed parents and/or guardians of teenagers.¹⁵

Results by Outcomes Provider Identification and Understanding of Physicians’ Roles

Four studies that assessed the influence of visual tools on provider identification and understanding of roles reported a positive association.^15,25,28,31 Visual tools varied between pictures (n = 2),^15,31 patient portal (n = 1),²⁸ and whiteboards and pictures combined (n = 1).²⁵ The measurement of outcomes varied between surveys with free text responses,²⁸ multiple choice questions,²⁵ and 1-5 Likert scales.^15,31

Patient–Provider Communication

Two studies assessed the impact of patient portal use on communication and reported a positive association.^28,32 The 2 portals autopopulated names, pictures, and roles of providers from electronic medical records. Singh et al.²⁸ used a portal that was also available in Spanish and accommodated for non-English speakers. Kelly et al.³² reported that 90% of parents perceived that portal use was associated with reduced errors in care, with 8% finding errors in their child’s medication list.

Patient Satisfaction

Three studies assessed patient satisfaction via the use of visual tools.^15,28,31 Singh et al.²⁸ noted a positive influence on satisfaction via a patient portal. Dudas et al.¹⁵ used a single-page handout with names and pictures of each provider, along with information regarding the training and roles of each provider. Distribution of these handouts to patients by investigators led to a positive influence on satisfaction. While Unaka et al.³¹ used a similar handout, they asked residents to distribute them and found no significant difference in satisfaction scores between the intervention (66%) and control group (62%).

Results by Type of Visual Tool Pictures

Two studies reported a positive impact on provider identification and understanding of roles with the use of pictures.^15,31 Dudas et al.¹⁵ demonstrated a 4.8-fold increase in the odds of parents identifying a medical student, as compared with the control. Similarly, after adjusting for length of stay and prior hospitalization, Unaka et al.³¹ reported that a higher percentage of patients correctly identified providers using this approach.

Whiteboard and Picture

One study evaluated the simultaneous use of whiteboards and pictures to improve the identification of providers. The study noted improved identification of supervising doctors and increased recognition of roles for supervising doctors, residents, and medical students.²⁵

Patient Portal

Two studies used patient portals as visual tools. Singh et al.²⁸ assessed the use of a patient portal with names, roles, and pictures of treatment team members. Use of this tool was positively associated with provider identification, understanding of roles, communication, and satisfaction. Kelly et al.³² noted that 60% of parents felt that portal use improved healthcare team communication.

The risk of bias was assessed for both adult and pediatric studies in aggregate. The average risk of bias using the Downs and Black Scale was 17.81 (range 14-22, standard deviation [SD] 2.20). Of the 16 included studies, 9 were rated at a low risk of bias (score

• >

18).^13-15,26-31 Risk of bias was greatest for measures of external validity (mean 2.88, range 2-3, SD 0.34), internal validity (mean 4.06, range 3-6, SD 1.00), and confounding (mean 2.69, range 1-6, SD 1.35). Two of 3 randomized controlled trials had a low risk of bias.^14,27 Interrater reliability for study quality adjudication was 0.90, suggesting excellent agreement (see supplementary Appendix B).

In this systematic review, the effects of visual tools on outcomes, such as provider identification, understanding of roles, patient–provider communication, and satisfaction with care, were variable. The majority of included studies were conducted on adult patients (n = 11).^{12-14,22-24,26,27,29,30,33} Pictures were the most frequently used tool (n = 7)^{13-15,23,27,31,33} and consequently had the greatest sample size across the review (n = 1297). While pictures had a positive influence on provider identification in all studies, comprehension of provider roles and satisfaction were variable. Although the content of whiteboards varied between studies, they showed favorable effects on provider identification (3 of 4 studies)^12,22,30 and satisfaction (2 of 2 studies).^22,30 While electronic medical record-based tools had a positive influence on outcomes,^26,28 only 1 accounted for language preferences.²⁸ Formatted notepads positively influenced patient–provider communication, but their use was limited by literacy.²⁴ Collectively, these data suggest that visual tools have varying effects on patient-reported outcomes, likely owing to differences in study design, interventions, and evaluation methods.

Theoretically, visual tools should facilitate easier identification of providers and engender collaborative relationships. However, such tools do not replace face-to-face patient–provider and family discussions. Rather, these enhancements best serve as a medium to asynchronously display information to patients and family members. Indeed, within the included studies, we found that the use of visual tools was effective in improving satisfaction (6/8 studies), identification (13/13 studies), and understanding of provider roles (8/10 studies). Thus, it is reasonable to say that, in conjunction with excellent clinical care, these tools have an important role in improving care delivery in the hospital.

Despite this promise, we noted that the effectiveness of individual tools varied, a fact that may relate to differences across studies. First, inconsistencies in the format and/or content of the tools were noted. For example, within studies using pictures, tools varied from individual photographs of each team member^13,23 to 1-page handouts with pictures of all team members.^14,15,31 Such differences in presentation could affect spatial recognition in identifying providers, as single photos are known to be easier to process than multiple images at the same time.³⁴ Second, no study evaluated patient preference of a visual tool. Thus, personal preferences for pictures versus whiteboards versus electronic modalities or a combination of tools might affect outcomes. Additionally, the utility of visual tools in visually impaired, confused, or non-English-speaking patients may limit effectiveness. Future studies that address these aspects and account for patient preferences may better elucidate the role of visual tools in hospitals.

Our results should be considered in the context of several limitations. First, only 3 studies used randomized trial designs; thus, confounding from unmeasured variables inherent to observational designs is possible. Second, none of the interventions tested were blinded to providers, raising the possibility of a Hawthorne effect (ie, alteration of provider behavior in response to awareness of being observed).³⁵ Third, all studies were conducted at single centers, and only 9 of 16 studies were rated at a low risk of bias; thus, caution in broad extrapolations of this literature is necessary.

However, our study has several strengths, including a thorough search of heterogeneous literature, inclusion of both adult and pediatric populations, and a focus on myriad patient-reported outcomes. Second, by contrasting outcomes and measurement strategies across studies, our review helps explicate differences in results related to variation in outcome measurement or presentation of visual data. Third, because we frame results by outcome and type of visual tool used, we are able to identify strengths and weaknesses of individual tools in novel ways. Finally, our data suggest that the use of picture-based techniques and whiteboards are among the most promising visual interventions. Future studies that pair graphic designers with patients to improve the layout of these tools might prove valuable. Additionally, because the measurement of outcomes is confounded by aspects such as lack of controls, severity of illness, and language barriers, a randomized design would help provide greater clarity regarding effectiveness.

In conclusion, we found that visual tools appear to foster recognition of providers and understanding of their roles. However, variability of format, content, and measurement of outcomes hinders the identification of a single optimal approach. Future work using randomized controlled trial designs and standardized tools and measurements would be welcomed.

Acknowledgments

The authors thank Laura Appel, Kevin O’Leary, and Siddharth Singh for providing unpublished data and clarifications to help these analyses.

Disclosure

 Anupama Goyal is the guarantor. Anupama Goyal and Komalpreet Tur performed primary data abstraction and analysis. Anupama Goyal, Scott Flanders, Jason Mann, and Vineet Chopra drafted the manuscript. All authors contributed to the development of the selection criteria, the risk of bias assessment strategy, and the data extraction criteria. Anupama Goyal, Jason Mann, Whitney Townsend, and Vineet Chopra developed the search strategy. Vineet Chopra provided systematic review expertise. All authors read, provided feedback, and approved the final manuscript. The authors declare that they have no conflicts of interest.

Patient satisfaction with medical care during hospitalization is a common quality metric.^1,2 Studies showing higher patient satisfaction have reported lower 30-day hospital readmissions³ and improved overall health.^4,5 Conversely, communication failures are associated with dissatisfaction among hospitalized patients and adverse outcomes.^6,7 A lack of familiarity with hospital providers weakens collaborative decision making and prevents high-quality patient care.^8,9

Bedside visual tools, such as whiteboards and pictures of medical staff, have been widely used to enhance communication between patients, families, and providers.^10,11 Results of studies evaluating these tools are varied. For example, 1 study found that 98% of patients were better able to identify physicians when their names were written on whiteboards.¹² Yet in another, only 21.1% of patients were more likely to correctly identify ≥1 physicians using pictures.¹³ Thus, despite widespread use,¹¹ whether visual tools improve patient satisfaction and patient care more broadly remains unclear.^14,15

We performed a systematic review to answer the following 3 questions: first, what is the effect of visual tools on outcomes (ie, provider identification, understanding of providers’ roles, patient–provider communication, and satisfaction); second, does impact vary by type of visual tool (eg, whiteboards vs pictures of providers); and third, what factors (eg, study design, patient population) are associated with provider identification, communication, and patient satisfaction?

Search Strategy

We used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis when performing this review.¹⁶ A research librarian (WT) conducted serial searches for studies reporting the use of bedside visual tools for hospitalized patients in Medline (via OVID), Embase, SCOPUS, Web of Science, CINAHL, and Cochrane DSR and CENTRAL. Controlled vocabularies (ie, Medical Subject Headings terms) were used to identify synonyms for visual tools of interest. Additional studies were identified manually through bibliographies and meeting abstracts. No study design, publication date, or language restrictions were placed on the search, which was conducted between April 2016 and February 2017 (see supplementary Appendix A).

Study Selection

Two reviewers (AG and KT) independently assessed study eligibility; discrepancies were resolved by a third reviewer (VC). We included all adult or pediatric English language studies in which the effect of visual tool(s) on patient outcomes was reported. Visual tools were defined as the bedside display of information or an instrument given to patients to convey information regarding providers or medical care. Patient-reported outcomes included the following: (a) physician identification, (b) understanding of provider roles, (c) patient–provider communication, and (d) patient satisfaction with care. Providers were defined as physicians, residents, interns, medical students, nurse practitioners, or nurses. We excluded studies that were not original research (eg, conference abstracts, not peer reviewed), reported qualitative data without quantitative outcomes, or did not include a bedside visual tool. Given our interest in hospitalized general medicine patients, studies conducted in emergency departments, surgical units, obstetrics and gynecology wards, and intensive care units were excluded.

Data Extraction and Analysis

Data were extracted independently and in duplicate from all studies by using a template adapted from the Cochrane Collaboration.¹⁷ For all studies, we abstracted study design, type of visual tool (eg, whiteboards), unit setting (eg, medical), population studied (eg, adult vs pediatric), and outcomes reported (ie, physician identification, understanding of provider roles, communication, and satisfaction with care). Reviewers independently assessed and categorized the impact of tools on reported outcomes.

To standardize and compare outcomes across studies, the following were used to denote a positive association between visual tools and relevant outcomes: a greater number of physicians correctly identified by name/picture or title/role; the use of terms such as “high,” “agreed,” or “significant” on surveys; or ≥4 Likert scores for domains of identification, understanding of roles, communication, and satisfaction with care. Conversely, the inability to identify providers compared to the control/baseline; poor recall of titles/roles; lower Likert-scale scores (ie, ≤2); or survey terms such as “poor,” “disagreed,” or “insignificant” were considered to connote negative impact. Studies in which Likert scores were rated neither high nor low (ie, 3), or in which patients neither agreed nor disagreed on value were considered neutral.

Owing to clinical heterogeneity within studies, meta-analyses were not performed. Descriptive statistics were used to describe study outcomes. A priori¹⁸ studies were evaluated according to the following categories: design (eg, randomized vs observational), outcomes (eg, patient satisfaction), intervention (type of visual tool), and patient population (adult or pediatric). Because pediatric patients have underdeveloped communication skills and include parents and/or guardians, data from pediatric studies were tabulated and reported separately to those from adult studies.

Quality Assessment

As recommended by the Cochrane Collaboration, 2 reviewers (AG, KT) assessed the risk of study bias by using the Downs and Black Scale.^17,19 Discrepancies in assessment were resolved by a third reviewer (VC). This instrument uses a point-based system to estimate the quality of a study by rating domains such as internal and external validity, bias, and confounding. In keeping with prior systematic reviews,^18,20,21 studies with a score of ≥18 were considered high quality. Interrater agreement for the adjudication of study quality was calculated using the Cohen κ statistic.

Eleven studies were conducted on adult hospitalized pa­tients ^{12-14,22-24,26,27,29,30,33} and included 3 randomized controlled studies.^14,27,33

Results by Outcomes Provider Identification Nine studies measured patients’ ability to identify providers with the use of visual aids, and all 9 reported improvements in this outcome. Visual tools used to measure provider identification included pictures (n = 5),^{13,14,23,27,33} whiteboards (n = 3),^12,22,30 and patient portals (n = 1).²⁶ Within studies that used pictures, individual pictures (n = 2)^13,23 and handouts with pictures of multiple providers (n = 3) were used.^14,27,33 In 2 studies, care team members such as a dietitian, physiotherapist or pharmacist, were included when measuring identification.^14,33

Understanding Providers’ RolesSix studies assessed the effect of visual tools on patients’ understanding of provider roles.^{13,14,22,26,27,33} Four studies reported a positive effect with the use of pictures,^27,33 whiteboards,²² and patient portals.²⁶ However, 2 studies reported either no difference or negative impressions. Appel et al.¹⁴ reported no difference in the understanding of physician roles using a handout of providers’ pictures and titles. Arora et al.¹³ used individual pictures of physicians with descriptions of roles and found a negative association, as demonstrated by fewer patients rating their understanding of physicians’ roles as excellent or very good in the intervention period (45.6%) compared with the baseline (55.3%).

 

Patient–Provider Communication

Three studies evaluated the influence of visual tools on communication.^14,24,29 Using pictures, Appel et al.¹⁴ found no difference in the perceived quality of communication. Singh et al.²⁹ used whiteboards and reported improved communication scores for physicians and nurses. With notepads, patients surveyed by Farberg et al.²⁴ stated that the tool improved provider communication.

Patient Satisfaction

Five studies assessed patient satisfaction related to the use of visual tools. ^{22,23,27,30,33} One study reported satisfaction as positive with the use of individual pictures.²³ Two studies that used handouts with pictures of all team members reported either a positive³³ or neutral²⁷ impact on satisfaction. Studies that used whiteboards reported a positive association with satisfaction^22,30 despite differences in content, such as the inclusion of prewritten prompts for writing goals of care and scheduled tests³⁰ versus the name of the nurse and their education level.²²

Results by Type of Visual Tool Pictures

Five studies that used pictures reported a positive effect on provider identification.^{13,14,23,27,33} Two^27,33 of 4 studies^13,14,27,33 that assessed patients’ understanding of team member roles reported a positive influence, while 1 reported no difference.¹⁴ A fourth study demonstrated a negative association, perhaps due to differences in the description of providers’ roles listed on the tool.¹³ Only 1 study examined the influence of pictures on patient–provider communication, and this study found no difference.¹⁴ Satisfaction with care via the use of pictures varied between positive (2 studies)^23,33 and neutral (1 study).²⁷

Whiteboards

Four studies tested the use of whiteboards; of these, 3 reported a positive influence on provider identification.^12,22,30 One study reported a positive impact on patient–provider communication.²⁹ Two studies noted a positive effect on patient satisfaction.^22,30 Notably, the responsibility for updating whiteboards differed between the studies (ie, nurses only²² vs residents, medical students, and nurses).³⁰

Patient Portal

In 1 study, an electronic portal that included names with pictures of providers, descriptions of their roles, lists of medications, and scheduled tests and/or procedures was used as a visual tool. The portal improved patients’ identification of physicians and patients’ understanding of roles. However, improvements in the knowledge of medication changes and planned tests and/or procedures during hospitalization were not observed.²⁶ This finding would suggest limitations in the hospitalized patient’s knowledge of the plan of care, which could potentially weaken patient–provider communication.

Notepads

Only 1 study assessed the use of formatted notepads on patient–provider communication and noted a positive association. Notepads used prompts for different categories (eg, diagnosis/treatment, medications, etc) to encourage patient questions for providers.²⁴

Five studies were conducted on hospitalized pediatric units.^{15,25,28,31,32} All studies surveyed the parents, guardians, or caregivers of pediatric patients. One study excluded patients ≥12 years of age because of legal differences in access to adolescent health information,³² while another interviewed parents and/or guardians of teenagers.¹⁵

Results by Outcomes Provider Identification and Understanding of Physicians’ Roles

Four studies that assessed the influence of visual tools on provider identification and understanding of roles reported a positive association.^15,25,28,31 Visual tools varied between pictures (n = 2),^15,31 patient portal (n = 1),²⁸ and whiteboards and pictures combined (n = 1).²⁵ The measurement of outcomes varied between surveys with free text responses,²⁸ multiple choice questions,²⁵ and 1-5 Likert scales.^15,31

Patient–Provider Communication

Two studies assessed the impact of patient portal use on communication and reported a positive association.^28,32 The 2 portals autopopulated names, pictures, and roles of providers from electronic medical records. Singh et al.²⁸ used a portal that was also available in Spanish and accommodated for non-English speakers. Kelly et al.³² reported that 90% of parents perceived that portal use was associated with reduced errors in care, with 8% finding errors in their child’s medication list.

Patient Satisfaction

Three studies assessed patient satisfaction via the use of visual tools.^15,28,31 Singh et al.²⁸ noted a positive influence on satisfaction via a patient portal. Dudas et al.¹⁵ used a single-page handout with names and pictures of each provider, along with information regarding the training and roles of each provider. Distribution of these handouts to patients by investigators led to a positive influence on satisfaction. While Unaka et al.³¹ used a similar handout, they asked residents to distribute them and found no significant difference in satisfaction scores between the intervention (66%) and control group (62%).

Results by Type of Visual Tool Pictures

Two studies reported a positive impact on provider identification and understanding of roles with the use of pictures.^15,31 Dudas et al.¹⁵ demonstrated a 4.8-fold increase in the odds of parents identifying a medical student, as compared with the control. Similarly, after adjusting for length of stay and prior hospitalization, Unaka et al.³¹ reported that a higher percentage of patients correctly identified providers using this approach.

Whiteboard and Picture

One study evaluated the simultaneous use of whiteboards and pictures to improve the identification of providers. The study noted improved identification of supervising doctors and increased recognition of roles for supervising doctors, residents, and medical students.²⁵

Patient Portal

Two studies used patient portals as visual tools. Singh et al.²⁸ assessed the use of a patient portal with names, roles, and pictures of treatment team members. Use of this tool was positively associated with provider identification, understanding of roles, communication, and satisfaction. Kelly et al.³² noted that 60% of parents felt that portal use improved healthcare team communication.

The risk of bias was assessed for both adult and pediatric studies in aggregate. The average risk of bias using the Downs and Black Scale was 17.81 (range 14-22, standard deviation [SD] 2.20). Of the 16 included studies, 9 were rated at a low risk of bias (score

• >

18).^13-15,26-31 Risk of bias was greatest for measures of external validity (mean 2.88, range 2-3, SD 0.34), internal validity (mean 4.06, range 3-6, SD 1.00), and confounding (mean 2.69, range 1-6, SD 1.35). Two of 3 randomized controlled trials had a low risk of bias.^14,27 Interrater reliability for study quality adjudication was 0.90, suggesting excellent agreement (see supplementary Appendix B).

In this systematic review, the effects of visual tools on outcomes, such as provider identification, understanding of roles, patient–provider communication, and satisfaction with care, were variable. The majority of included studies were conducted on adult patients (n = 11).^{12-14,22-24,26,27,29,30,33} Pictures were the most frequently used tool (n = 7)^{13-15,23,27,31,33} and consequently had the greatest sample size across the review (n = 1297). While pictures had a positive influence on provider identification in all studies, comprehension of provider roles and satisfaction were variable. Although the content of whiteboards varied between studies, they showed favorable effects on provider identification (3 of 4 studies)^12,22,30 and satisfaction (2 of 2 studies).^22,30 While electronic medical record-based tools had a positive influence on outcomes,^26,28 only 1 accounted for language preferences.²⁸ Formatted notepads positively influenced patient–provider communication, but their use was limited by literacy.²⁴ Collectively, these data suggest that visual tools have varying effects on patient-reported outcomes, likely owing to differences in study design, interventions, and evaluation methods.

Theoretically, visual tools should facilitate easier identification of providers and engender collaborative relationships. However, such tools do not replace face-to-face patient–provider and family discussions. Rather, these enhancements best serve as a medium to asynchronously display information to patients and family members. Indeed, within the included studies, we found that the use of visual tools was effective in improving satisfaction (6/8 studies), identification (13/13 studies), and understanding of provider roles (8/10 studies). Thus, it is reasonable to say that, in conjunction with excellent clinical care, these tools have an important role in improving care delivery in the hospital.

Despite this promise, we noted that the effectiveness of individual tools varied, a fact that may relate to differences across studies. First, inconsistencies in the format and/or content of the tools were noted. For example, within studies using pictures, tools varied from individual photographs of each team member^13,23 to 1-page handouts with pictures of all team members.^14,15,31 Such differences in presentation could affect spatial recognition in identifying providers, as single photos are known to be easier to process than multiple images at the same time.³⁴ Second, no study evaluated patient preference of a visual tool. Thus, personal preferences for pictures versus whiteboards versus electronic modalities or a combination of tools might affect outcomes. Additionally, the utility of visual tools in visually impaired, confused, or non-English-speaking patients may limit effectiveness. Future studies that address these aspects and account for patient preferences may better elucidate the role of visual tools in hospitals.

Our results should be considered in the context of several limitations. First, only 3 studies used randomized trial designs; thus, confounding from unmeasured variables inherent to observational designs is possible. Second, none of the interventions tested were blinded to providers, raising the possibility of a Hawthorne effect (ie, alteration of provider behavior in response to awareness of being observed).³⁵ Third, all studies were conducted at single centers, and only 9 of 16 studies were rated at a low risk of bias; thus, caution in broad extrapolations of this literature is necessary.

However, our study has several strengths, including a thorough search of heterogeneous literature, inclusion of both adult and pediatric populations, and a focus on myriad patient-reported outcomes. Second, by contrasting outcomes and measurement strategies across studies, our review helps explicate differences in results related to variation in outcome measurement or presentation of visual data. Third, because we frame results by outcome and type of visual tool used, we are able to identify strengths and weaknesses of individual tools in novel ways. Finally, our data suggest that the use of picture-based techniques and whiteboards are among the most promising visual interventions. Future studies that pair graphic designers with patients to improve the layout of these tools might prove valuable. Additionally, because the measurement of outcomes is confounded by aspects such as lack of controls, severity of illness, and language barriers, a randomized design would help provide greater clarity regarding effectiveness.

In conclusion, we found that visual tools appear to foster recognition of providers and understanding of their roles. However, variability of format, content, and measurement of outcomes hinders the identification of a single optimal approach. Future work using randomized controlled trial designs and standardized tools and measurements would be welcomed.

Acknowledgments

The authors thank Laura Appel, Kevin O’Leary, and Siddharth Singh for providing unpublished data and clarifications to help these analyses.

Disclosure

 Anupama Goyal is the guarantor. Anupama Goyal and Komalpreet Tur performed primary data abstraction and analysis. Anupama Goyal, Scott Flanders, Jason Mann, and Vineet Chopra drafted the manuscript. All authors contributed to the development of the selection criteria, the risk of bias assessment strategy, and the data extraction criteria. Anupama Goyal, Jason Mann, Whitney Townsend, and Vineet Chopra developed the search strategy. Vineet Chopra provided systematic review expertise. All authors read, provided feedback, and approved the final manuscript. The authors declare that they have no conflicts of interest.

Abstract

• Background: Although transfusion guidelines have changed considerably over the past 2 decades, the adoption of patient blood management programs has not been fully realized across hospitals in the United States.
• Objective: To evaluate trends in red blood cell (RBC), platelet, and plasma transfusion at 3 Veterans Health Administration (VHA) hospitals from 2000 through 2010.
• Methods: Data from all hospitalizations were collected from January 2000 through December 2010. Blood bank data (including the type and volume of products administered) were available electronically from each hospital. These files were linked to inpatient data, which included ICD-9-CM diagnoses (principal and secondary) and procedures during hospitalization. Statistical analyses were conducted using generalized linear models to evaluate trends over time. The unit of observation was hospitalization, with categorization by type.
• Results: There were 176,521 hospitalizations in 69,621 patients; of these, 13.6% of hospitalizations involved transfusion of blood products (12.7% RBCs, 1.4% platelets, 3.0% plasma). Transfusion occurred in 25.2% of surgical and 5.3% of medical hospitalizations. Transfusion use peaked in 2002 for surgical hospitalizations and declined afterwards (P < 0.001). There was no significant change in transfusion use over time (P = 0.126) for medical hospitalizations. In hospitalizations that involved transfusions, there was a 20.3% reduction in the proportion of hospitalizations in which ≥ 3 units of RBCs were given (from 51.7% to 41.1%; P < 0.001) and a 73.6% increase when 1 RBC unit was given (from 8.0% to 13.8%; P < 0.001) from 2000-2010. Of the hospitalizations with RBC transfusion, 9.6% involved the use of 1 unit over the entire study period. The most common principal diagnoses for medical patients receiving transfusion were anemia, malignancy, heart failure, pneumonia and renal failure. Over time, transfusion utilization increased in patients who were admitted for infection (P = 0.009).
• Conclusion: Blood transfusions in 3 VHA hospitals have decreased over time for surgical patients but remained the same for medical patients. Further study examining appropriateness of blood products in medical patients appears necessary.

Key words: Transfusion; red blood cells; plasma; platelets; veterans.

Transfusion practices during hospitalization have changed considerably over the past 2 decades. Guided by evidence from randomized controlled trials, patient blood management programs have been expanded [1]. Such programs include recommendations regarding minimization of blood loss during surgery, prevention and treatment of anemia, strategies for reducing transfusions in both medical and surgical patients, improved blood utilization, education of health professionals, and standardization of blood management-related metrics [2]. Some of the guidelines have been incorporated into the Choosing Wisely initiative of the American Board of Internal Medicine Foundation, including: (a) don’t transfuse more units of blood than absolutely necessary, (b) don’t transfuse red blood cells for iron deficiency without hemodynamic instability, (c) don’t routinely use blood products to reverse warfarin, and (d) don’t perform serial blood counts on clinically stable patients [3]. Although there has been growing interest in blood management, only 37.8% of the 607 AABB (formerly, American Association of Blood Banks) facilities in the United States reported having a patient blood management program in 2013 [2].

While the importance of blood safety is recognized, data regarding the overall trends in practices are conflicting. A study using the Nationwide Inpatient Sample indicated that there was a 5.6% annual mean increase in the transfusion of blood products from 2002 to 2011 in the United States [4]. This contrasts with the experience of Kaiser Permanente in Northern California, in which the incidence of RBC transfusion decreased by 3.2% from 2009 to 2013 [5]. A decline in rates of intraoperative transfusion was also reported among elderly veterans in the United States from 1997 to 2009 [6].

We conducted a study in hospitalized veterans with 2 main objectives: (a) to evaluate trends in utilization of red blood cells (RBCs), platelets, and plasma over time, and (b) to identify those groups of veterans who received specific blood products. We were particularly interested in transfusion use in medical patients.

Methods

Participants were hospitalized veterans at 3 Department of Veterans Affairs (VA) medical centers. Data from all hospitalizations were collected from January 2000 through December 2010. Blood bank data (including the type and volume of products administered) were available electronically from each hospital. These files were linked to inpatient data, which included ICD-9-CM diagnoses (principal and secondary) and procedures during hospitalization.

Statistical analyses were conducted using generalized linear models to evaluate trends over time. The unit of observation was hospitalization, with categorization by type. Surgical hospitalizations were defined as admissions in which any surgical procedure occurred, whereas medical hospitalizations were defined as admissions without any surgery. Alpha was set at 0.05, 2-tailed. All analyses were conducted in Stata/MP 14.1 (StataCorp, College Station, TX). The study received institutional review board approval from the VA Ann Arbor Healthcare System.

Results

From 2000 through 2010, there were 176,521 hospitalizations in 69,621 patients. Within this cohort, 6% were < 40 years of age, 66% were 40 to 69 years of age, and 28% were 70 years or older at the time of admission. In this cohort, 96% of patients were male. Overall, 13.6% of all hospitalizations involved transfusion of a blood product (12.7% RBCs, 1.4% platelets, 3.0% plasma).

Transfusion occurred in 25.2% of surgical hospitalizations and 5.3% of medical hospitalizations. For surgical hospitalizations, transfusion use peaked in 2002 (when 30.9% of the surgical hospitalizations involved a trans-fusion) and significantly declined afterwards (P < 0.001). By 2010, 22.5% of the surgical hospitalizations involved a transfusion. Most of the surgeries where blood products were transfused involved cardiovascular procedures. For medical hospitalizations only, there was no significant change in transfusion use over time, either from 2000 to 2010 (P = 0.126) or from 2002 to 2010 (P = 0.072). In 2010, 5.2% of the medical hospitalizations involved a transfusion.

Rates of transfusion varied by principal diagnosis (Figure 1). For patients admitted with a principal diagnosis of infection (n = 20,981 hospitalizations), there was an increase in the percentage of hospitalizations in which transfusions (RBCs, platelet, plasma) were administered over time (P = 0.009) (Figure 1). For patients admitted with a principal diagnosis of malignancy (n = 12,904 hospitalizations), cardiovascular disease (n = 40,324 hospitalizations), and other diagnoses (n = 102,312 hospitalizations), there were no significant linear trends over the entire study period (P = 0.191, P = 0.052, P = 0.314, respectively). Rather, blood utilization peaked in year 2002 and significantly declined afterwards for patients admitted for malignancy (P < 0.001) and for cardiovascular disease (P < 0.001).

The most common principal diagnoses for medical patients receiving any transfusion (RBCs, platelet, plasma) are listed in Table 1. For medical patients with a principal diagnosis of anemia, 88% of hospitalizations involved a transfusion (Table 1). Transfusion occurred in 6% to 11% of medical hospitalizations with malignancies, heart failure, pneumonia or renal failure (Table 1). A considerable proportion (43%) of medical patients with gastrointestinal hemorrhage received a transfusion.

Discussion

We also observed secular trends in the volume of RBCs administered. There was an increase in the percentage of hospitalizations in which 1 or 2 RBC units were used and a decline in transfusion of 3 or more units. The reduction in the use of 3 or more RBC units may reflect the adoption and integration of recommendations in patient blood management by clinicians,

which encourage assessment of the patients’ symptoms in determining whether additional units are necessary [7]. Such guidelines also endorse the avoidance of routine
administration of 2 units of RBCs if 1 unit is sufficient [8]. We have previously shown that, after coronary artery bypass grafting, 2 RBC units doubled the risk of pneumonia [9]; additional analyses indicated that 1 or 2 units of RBCs were associated with increased postoperative morbidity [10]. In addition, our previous research indicated that the probability of infection increased considerably between 1 and 2 RBC units, with a more gradual increase beyond 2 units [11]. With this evidence in mind, some studies at single sites have reported that there was a dramatic decline from 2 RBC units before initiation of patient blood management programs to 1 unit after the programs were implemented [12,13].

Medical patients who received a transfusion were often admitted for reason of anemia, cancer, organ failure, or pneumonia. Some researchers are now reporting that blood use, at certain sites, is becoming more common in medical rather than surgical patients, which may be due to an expansion of patient blood management procedures in surgery [16]. There are a substantial number of patient blood management programs among surgical specialties and their adoption has expanded [17]. Although there are fewer patient blood management programs in the nonsurgical setting, some have been targeted to internal medicine physicians and specifically, to hospitalists [1,18]. For example, a toolkit from the Society of Hospital Medicine centers on anemia management and includes anemia assessment, treatment, evaluation of RBC transfusion risk, blood conservation, optimization of coagulation, and patient-centered decision-making [19]. Additionally, bundling of patient blood management strategies has been launched to help encourage a wider adoption of such programs [20].

While guidelines regarding use of RBCs are becoming increasingly recognized, recommendations for the use of platelets and plasma are hampered by the paucity of evidence from randomized controlled trials [21,22]. There is moderate-quality evidence for the use of platelets with therapy-induced hypoproliferative thrombocytopenia in hospitalized patients [21], but low quality evidence for other uses. Moreover, a recent review of plasma transfusion in bleeding patients found no randomized controlled trials on plasma use in hospitalized patients, although several trials were currently underway [22].

Our findings need to be considered in the context of the following limitations. The data were from 3 VA hospitals, so the results may not reflect patterns of usage at other hospitals. However, AABB reports that there has been a general decrease in transfusion of allogeneic whole blood and RBC units since 2008 at the AABB-affiliated sites in the United States [2]; this is similar to the pattern that we observed in surgical patients. In addition, we report an overall view of trends without having details regarding which specific factors influenced changes in transfusion during this 11-year period. It is possible that the severity of hospitalized patients may have changed with time which could have influenced decisions regarding the need for transfusion.

In conclusion, the use of blood products decreased in surgical patients since 2002 but remained the same in medical patients in this VA population. Transfusions increased over time for patients who were admitted to the hospital for reason of infection, but decreased since 2002 for those admitted for cardiovascular disease or cancer. The number of RBC units per hospitalization decreased over time. Additional surveillance is needed to determine whether recent evidence regarding blood management has been incorporated into clinical practice for medical patients, as we strive to deliver optimal care to our veterans.

Corresponding author: Mary A.M. Rogers, PhD, MS, Dept. of Internal Medicine, Univ. of Michigan, 016-422W NCRC, Ann Arbor, MI 48109-2800, maryroge@umich.edu.

Funding/support: Department of Veterans Affairs, Clinical Sciences Research & Development Service Merit Review Award (EPID-011-11S). The contents do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

Financial disclosures: None.

Author contributions: conception and design, MAMR, SS; analysis and interpretation of data, MAMR, JDB, DR, LK, SS; drafting of article, MAMR; critical revision of the article, MAMR, MTG, DR, LK, SS, VC; statistical expertise, MAMR, DR; obtaining of funding, MTG, SS, VC; administrative or technical support, MTG, LK, SS, VC; collection and assembly of data, JDB, LK.

Abstract

• Background: Although transfusion guidelines have changed considerably over the past 2 decades, the adoption of patient blood management programs has not been fully realized across hospitals in the United States.
• Objective: To evaluate trends in red blood cell (RBC), platelet, and plasma transfusion at 3 Veterans Health Administration (VHA) hospitals from 2000 through 2010.
• Methods: Data from all hospitalizations were collected from January 2000 through December 2010. Blood bank data (including the type and volume of products administered) were available electronically from each hospital. These files were linked to inpatient data, which included ICD-9-CM diagnoses (principal and secondary) and procedures during hospitalization. Statistical analyses were conducted using generalized linear models to evaluate trends over time. The unit of observation was hospitalization, with categorization by type.
• Results: There were 176,521 hospitalizations in 69,621 patients; of these, 13.6% of hospitalizations involved transfusion of blood products (12.7% RBCs, 1.4% platelets, 3.0% plasma). Transfusion occurred in 25.2% of surgical and 5.3% of medical hospitalizations. Transfusion use peaked in 2002 for surgical hospitalizations and declined afterwards (P < 0.001). There was no significant change in transfusion use over time (P = 0.126) for medical hospitalizations. In hospitalizations that involved transfusions, there was a 20.3% reduction in the proportion of hospitalizations in which ≥ 3 units of RBCs were given (from 51.7% to 41.1%; P < 0.001) and a 73.6% increase when 1 RBC unit was given (from 8.0% to 13.8%; P < 0.001) from 2000-2010. Of the hospitalizations with RBC transfusion, 9.6% involved the use of 1 unit over the entire study period. The most common principal diagnoses for medical patients receiving transfusion were anemia, malignancy, heart failure, pneumonia and renal failure. Over time, transfusion utilization increased in patients who were admitted for infection (P = 0.009).
• Conclusion: Blood transfusions in 3 VHA hospitals have decreased over time for surgical patients but remained the same for medical patients. Further study examining appropriateness of blood products in medical patients appears necessary.

Key words: Transfusion; red blood cells; plasma; platelets; veterans.

Transfusion practices during hospitalization have changed considerably over the past 2 decades. Guided by evidence from randomized controlled trials, patient blood management programs have been expanded [1]. Such programs include recommendations regarding minimization of blood loss during surgery, prevention and treatment of anemia, strategies for reducing transfusions in both medical and surgical patients, improved blood utilization, education of health professionals, and standardization of blood management-related metrics [2]. Some of the guidelines have been incorporated into the Choosing Wisely initiative of the American Board of Internal Medicine Foundation, including: (a) don’t transfuse more units of blood than absolutely necessary, (b) don’t transfuse red blood cells for iron deficiency without hemodynamic instability, (c) don’t routinely use blood products to reverse warfarin, and (d) don’t perform serial blood counts on clinically stable patients [3]. Although there has been growing interest in blood management, only 37.8% of the 607 AABB (formerly, American Association of Blood Banks) facilities in the United States reported having a patient blood management program in 2013 [2].

While the importance of blood safety is recognized, data regarding the overall trends in practices are conflicting. A study using the Nationwide Inpatient Sample indicated that there was a 5.6% annual mean increase in the transfusion of blood products from 2002 to 2011 in the United States [4]. This contrasts with the experience of Kaiser Permanente in Northern California, in which the incidence of RBC transfusion decreased by 3.2% from 2009 to 2013 [5]. A decline in rates of intraoperative transfusion was also reported among elderly veterans in the United States from 1997 to 2009 [6].

We conducted a study in hospitalized veterans with 2 main objectives: (a) to evaluate trends in utilization of red blood cells (RBCs), platelets, and plasma over time, and (b) to identify those groups of veterans who received specific blood products. We were particularly interested in transfusion use in medical patients.

Methods

Participants were hospitalized veterans at 3 Department of Veterans Affairs (VA) medical centers. Data from all hospitalizations were collected from January 2000 through December 2010. Blood bank data (including the type and volume of products administered) were available electronically from each hospital. These files were linked to inpatient data, which included ICD-9-CM diagnoses (principal and secondary) and procedures during hospitalization.

Statistical analyses were conducted using generalized linear models to evaluate trends over time. The unit of observation was hospitalization, with categorization by type. Surgical hospitalizations were defined as admissions in which any surgical procedure occurred, whereas medical hospitalizations were defined as admissions without any surgery. Alpha was set at 0.05, 2-tailed. All analyses were conducted in Stata/MP 14.1 (StataCorp, College Station, TX). The study received institutional review board approval from the VA Ann Arbor Healthcare System.

Results

From 2000 through 2010, there were 176,521 hospitalizations in 69,621 patients. Within this cohort, 6% were < 40 years of age, 66% were 40 to 69 years of age, and 28% were 70 years or older at the time of admission. In this cohort, 96% of patients were male. Overall, 13.6% of all hospitalizations involved transfusion of a blood product (12.7% RBCs, 1.4% platelets, 3.0% plasma).

Transfusion occurred in 25.2% of surgical hospitalizations and 5.3% of medical hospitalizations. For surgical hospitalizations, transfusion use peaked in 2002 (when 30.9% of the surgical hospitalizations involved a trans-fusion) and significantly declined afterwards (P < 0.001). By 2010, 22.5% of the surgical hospitalizations involved a transfusion. Most of the surgeries where blood products were transfused involved cardiovascular procedures. For medical hospitalizations only, there was no significant change in transfusion use over time, either from 2000 to 2010 (P = 0.126) or from 2002 to 2010 (P = 0.072). In 2010, 5.2% of the medical hospitalizations involved a transfusion.

Rates of transfusion varied by principal diagnosis (Figure 1). For patients admitted with a principal diagnosis of infection (n = 20,981 hospitalizations), there was an increase in the percentage of hospitalizations in which transfusions (RBCs, platelet, plasma) were administered over time (P = 0.009) (Figure 1). For patients admitted with a principal diagnosis of malignancy (n = 12,904 hospitalizations), cardiovascular disease (n = 40,324 hospitalizations), and other diagnoses (n = 102,312 hospitalizations), there were no significant linear trends over the entire study period (P = 0.191, P = 0.052, P = 0.314, respectively). Rather, blood utilization peaked in year 2002 and significantly declined afterwards for patients admitted for malignancy (P < 0.001) and for cardiovascular disease (P < 0.001).

The most common principal diagnoses for medical patients receiving any transfusion (RBCs, platelet, plasma) are listed in Table 1. For medical patients with a principal diagnosis of anemia, 88% of hospitalizations involved a transfusion (Table 1). Transfusion occurred in 6% to 11% of medical hospitalizations with malignancies, heart failure, pneumonia or renal failure (Table 1). A considerable proportion (43%) of medical patients with gastrointestinal hemorrhage received a transfusion.

Discussion

We also observed secular trends in the volume of RBCs administered. There was an increase in the percentage of hospitalizations in which 1 or 2 RBC units were used and a decline in transfusion of 3 or more units. The reduction in the use of 3 or more RBC units may reflect the adoption and integration of recommendations in patient blood management by clinicians,

which encourage assessment of the patients’ symptoms in determining whether additional units are necessary [7]. Such guidelines also endorse the avoidance of routine
administration of 2 units of RBCs if 1 unit is sufficient [8]. We have previously shown that, after coronary artery bypass grafting, 2 RBC units doubled the risk of pneumonia [9]; additional analyses indicated that 1 or 2 units of RBCs were associated with increased postoperative morbidity [10]. In addition, our previous research indicated that the probability of infection increased considerably between 1 and 2 RBC units, with a more gradual increase beyond 2 units [11]. With this evidence in mind, some studies at single sites have reported that there was a dramatic decline from 2 RBC units before initiation of patient blood management programs to 1 unit after the programs were implemented [12,13].

Medical patients who received a transfusion were often admitted for reason of anemia, cancer, organ failure, or pneumonia. Some researchers are now reporting that blood use, at certain sites, is becoming more common in medical rather than surgical patients, which may be due to an expansion of patient blood management procedures in surgery [16]. There are a substantial number of patient blood management programs among surgical specialties and their adoption has expanded [17]. Although there are fewer patient blood management programs in the nonsurgical setting, some have been targeted to internal medicine physicians and specifically, to hospitalists [1,18]. For example, a toolkit from the Society of Hospital Medicine centers on anemia management and includes anemia assessment, treatment, evaluation of RBC transfusion risk, blood conservation, optimization of coagulation, and patient-centered decision-making [19]. Additionally, bundling of patient blood management strategies has been launched to help encourage a wider adoption of such programs [20].

While guidelines regarding use of RBCs are becoming increasingly recognized, recommendations for the use of platelets and plasma are hampered by the paucity of evidence from randomized controlled trials [21,22]. There is moderate-quality evidence for the use of platelets with therapy-induced hypoproliferative thrombocytopenia in hospitalized patients [21], but low quality evidence for other uses. Moreover, a recent review of plasma transfusion in bleeding patients found no randomized controlled trials on plasma use in hospitalized patients, although several trials were currently underway [22].

Our findings need to be considered in the context of the following limitations. The data were from 3 VA hospitals, so the results may not reflect patterns of usage at other hospitals. However, AABB reports that there has been a general decrease in transfusion of allogeneic whole blood and RBC units since 2008 at the AABB-affiliated sites in the United States [2]; this is similar to the pattern that we observed in surgical patients. In addition, we report an overall view of trends without having details regarding which specific factors influenced changes in transfusion during this 11-year period. It is possible that the severity of hospitalized patients may have changed with time which could have influenced decisions regarding the need for transfusion.

In conclusion, the use of blood products decreased in surgical patients since 2002 but remained the same in medical patients in this VA population. Transfusions increased over time for patients who were admitted to the hospital for reason of infection, but decreased since 2002 for those admitted for cardiovascular disease or cancer. The number of RBC units per hospitalization decreased over time. Additional surveillance is needed to determine whether recent evidence regarding blood management has been incorporated into clinical practice for medical patients, as we strive to deliver optimal care to our veterans.

Corresponding author: Mary A.M. Rogers, PhD, MS, Dept. of Internal Medicine, Univ. of Michigan, 016-422W NCRC, Ann Arbor, MI 48109-2800, maryroge@umich.edu.

Funding/support: Department of Veterans Affairs, Clinical Sciences Research & Development Service Merit Review Award (EPID-011-11S). The contents do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

Financial disclosures: None.

Author contributions: conception and design, MAMR, SS; analysis and interpretation of data, MAMR, JDB, DR, LK, SS; drafting of article, MAMR; critical revision of the article, MAMR, MTG, DR, LK, SS, VC; statistical expertise, MAMR, DR; obtaining of funding, MTG, SS, VC; administrative or technical support, MTG, LK, SS, VC; collection and assembly of data, JDB, LK.

Abstract

• Background: Although transfusion guidelines have changed considerably over the past 2 decades, the adoption of patient blood management programs has not been fully realized across hospitals in the United States.
• Objective: To evaluate trends in red blood cell (RBC), platelet, and plasma transfusion at 3 Veterans Health Administration (VHA) hospitals from 2000 through 2010.
• Methods: Data from all hospitalizations were collected from January 2000 through December 2010. Blood bank data (including the type and volume of products administered) were available electronically from each hospital. These files were linked to inpatient data, which included ICD-9-CM diagnoses (principal and secondary) and procedures during hospitalization. Statistical analyses were conducted using generalized linear models to evaluate trends over time. The unit of observation was hospitalization, with categorization by type.
• Results: There were 176,521 hospitalizations in 69,621 patients; of these, 13.6% of hospitalizations involved transfusion of blood products (12.7% RBCs, 1.4% platelets, 3.0% plasma). Transfusion occurred in 25.2% of surgical and 5.3% of medical hospitalizations. Transfusion use peaked in 2002 for surgical hospitalizations and declined afterwards (P < 0.001). There was no significant change in transfusion use over time (P = 0.126) for medical hospitalizations. In hospitalizations that involved transfusions, there was a 20.3% reduction in the proportion of hospitalizations in which ≥ 3 units of RBCs were given (from 51.7% to 41.1%; P < 0.001) and a 73.6% increase when 1 RBC unit was given (from 8.0% to 13.8%; P < 0.001) from 2000-2010. Of the hospitalizations with RBC transfusion, 9.6% involved the use of 1 unit over the entire study period. The most common principal diagnoses for medical patients receiving transfusion were anemia, malignancy, heart failure, pneumonia and renal failure. Over time, transfusion utilization increased in patients who were admitted for infection (P = 0.009).
• Conclusion: Blood transfusions in 3 VHA hospitals have decreased over time for surgical patients but remained the same for medical patients. Further study examining appropriateness of blood products in medical patients appears necessary.

Key words: Transfusion; red blood cells; plasma; platelets; veterans.

Transfusion practices during hospitalization have changed considerably over the past 2 decades. Guided by evidence from randomized controlled trials, patient blood management programs have been expanded [1]. Such programs include recommendations regarding minimization of blood loss during surgery, prevention and treatment of anemia, strategies for reducing transfusions in both medical and surgical patients, improved blood utilization, education of health professionals, and standardization of blood management-related metrics [2]. Some of the guidelines have been incorporated into the Choosing Wisely initiative of the American Board of Internal Medicine Foundation, including: (a) don’t transfuse more units of blood than absolutely necessary, (b) don’t transfuse red blood cells for iron deficiency without hemodynamic instability, (c) don’t routinely use blood products to reverse warfarin, and (d) don’t perform serial blood counts on clinically stable patients [3]. Although there has been growing interest in blood management, only 37.8% of the 607 AABB (formerly, American Association of Blood Banks) facilities in the United States reported having a patient blood management program in 2013 [2].

While the importance of blood safety is recognized, data regarding the overall trends in practices are conflicting. A study using the Nationwide Inpatient Sample indicated that there was a 5.6% annual mean increase in the transfusion of blood products from 2002 to 2011 in the United States [4]. This contrasts with the experience of Kaiser Permanente in Northern California, in which the incidence of RBC transfusion decreased by 3.2% from 2009 to 2013 [5]. A decline in rates of intraoperative transfusion was also reported among elderly veterans in the United States from 1997 to 2009 [6].

We conducted a study in hospitalized veterans with 2 main objectives: (a) to evaluate trends in utilization of red blood cells (RBCs), platelets, and plasma over time, and (b) to identify those groups of veterans who received specific blood products. We were particularly interested in transfusion use in medical patients.

Methods

Participants were hospitalized veterans at 3 Department of Veterans Affairs (VA) medical centers. Data from all hospitalizations were collected from January 2000 through December 2010. Blood bank data (including the type and volume of products administered) were available electronically from each hospital. These files were linked to inpatient data, which included ICD-9-CM diagnoses (principal and secondary) and procedures during hospitalization.

Statistical analyses were conducted using generalized linear models to evaluate trends over time. The unit of observation was hospitalization, with categorization by type. Surgical hospitalizations were defined as admissions in which any surgical procedure occurred, whereas medical hospitalizations were defined as admissions without any surgery. Alpha was set at 0.05, 2-tailed. All analyses were conducted in Stata/MP 14.1 (StataCorp, College Station, TX). The study received institutional review board approval from the VA Ann Arbor Healthcare System.

Results

From 2000 through 2010, there were 176,521 hospitalizations in 69,621 patients. Within this cohort, 6% were < 40 years of age, 66% were 40 to 69 years of age, and 28% were 70 years or older at the time of admission. In this cohort, 96% of patients were male. Overall, 13.6% of all hospitalizations involved transfusion of a blood product (12.7% RBCs, 1.4% platelets, 3.0% plasma).

Transfusion occurred in 25.2% of surgical hospitalizations and 5.3% of medical hospitalizations. For surgical hospitalizations, transfusion use peaked in 2002 (when 30.9% of the surgical hospitalizations involved a trans-fusion) and significantly declined afterwards (P < 0.001). By 2010, 22.5% of the surgical hospitalizations involved a transfusion. Most of the surgeries where blood products were transfused involved cardiovascular procedures. For medical hospitalizations only, there was no significant change in transfusion use over time, either from 2000 to 2010 (P = 0.126) or from 2002 to 2010 (P = 0.072). In 2010, 5.2% of the medical hospitalizations involved a transfusion.

Rates of transfusion varied by principal diagnosis (Figure 1). For patients admitted with a principal diagnosis of infection (n = 20,981 hospitalizations), there was an increase in the percentage of hospitalizations in which transfusions (RBCs, platelet, plasma) were administered over time (P = 0.009) (Figure 1). For patients admitted with a principal diagnosis of malignancy (n = 12,904 hospitalizations), cardiovascular disease (n = 40,324 hospitalizations), and other diagnoses (n = 102,312 hospitalizations), there were no significant linear trends over the entire study period (P = 0.191, P = 0.052, P = 0.314, respectively). Rather, blood utilization peaked in year 2002 and significantly declined afterwards for patients admitted for malignancy (P < 0.001) and for cardiovascular disease (P < 0.001).

The most common principal diagnoses for medical patients receiving any transfusion (RBCs, platelet, plasma) are listed in Table 1. For medical patients with a principal diagnosis of anemia, 88% of hospitalizations involved a transfusion (Table 1). Transfusion occurred in 6% to 11% of medical hospitalizations with malignancies, heart failure, pneumonia or renal failure (Table 1). A considerable proportion (43%) of medical patients with gastrointestinal hemorrhage received a transfusion.

Discussion

We also observed secular trends in the volume of RBCs administered. There was an increase in the percentage of hospitalizations in which 1 or 2 RBC units were used and a decline in transfusion of 3 or more units. The reduction in the use of 3 or more RBC units may reflect the adoption and integration of recommendations in patient blood management by clinicians,

which encourage assessment of the patients’ symptoms in determining whether additional units are necessary [7]. Such guidelines also endorse the avoidance of routine
administration of 2 units of RBCs if 1 unit is sufficient [8]. We have previously shown that, after coronary artery bypass grafting, 2 RBC units doubled the risk of pneumonia [9]; additional analyses indicated that 1 or 2 units of RBCs were associated with increased postoperative morbidity [10]. In addition, our previous research indicated that the probability of infection increased considerably between 1 and 2 RBC units, with a more gradual increase beyond 2 units [11]. With this evidence in mind, some studies at single sites have reported that there was a dramatic decline from 2 RBC units before initiation of patient blood management programs to 1 unit after the programs were implemented [12,13].

Medical patients who received a transfusion were often admitted for reason of anemia, cancer, organ failure, or pneumonia. Some researchers are now reporting that blood use, at certain sites, is becoming more common in medical rather than surgical patients, which may be due to an expansion of patient blood management procedures in surgery [16]. There are a substantial number of patient blood management programs among surgical specialties and their adoption has expanded [17]. Although there are fewer patient blood management programs in the nonsurgical setting, some have been targeted to internal medicine physicians and specifically, to hospitalists [1,18]. For example, a toolkit from the Society of Hospital Medicine centers on anemia management and includes anemia assessment, treatment, evaluation of RBC transfusion risk, blood conservation, optimization of coagulation, and patient-centered decision-making [19]. Additionally, bundling of patient blood management strategies has been launched to help encourage a wider adoption of such programs [20].

While guidelines regarding use of RBCs are becoming increasingly recognized, recommendations for the use of platelets and plasma are hampered by the paucity of evidence from randomized controlled trials [21,22]. There is moderate-quality evidence for the use of platelets with therapy-induced hypoproliferative thrombocytopenia in hospitalized patients [21], but low quality evidence for other uses. Moreover, a recent review of plasma transfusion in bleeding patients found no randomized controlled trials on plasma use in hospitalized patients, although several trials were currently underway [22].

Our findings need to be considered in the context of the following limitations. The data were from 3 VA hospitals, so the results may not reflect patterns of usage at other hospitals. However, AABB reports that there has been a general decrease in transfusion of allogeneic whole blood and RBC units since 2008 at the AABB-affiliated sites in the United States [2]; this is similar to the pattern that we observed in surgical patients. In addition, we report an overall view of trends without having details regarding which specific factors influenced changes in transfusion during this 11-year period. It is possible that the severity of hospitalized patients may have changed with time which could have influenced decisions regarding the need for transfusion.

In conclusion, the use of blood products decreased in surgical patients since 2002 but remained the same in medical patients in this VA population. Transfusions increased over time for patients who were admitted to the hospital for reason of infection, but decreased since 2002 for those admitted for cardiovascular disease or cancer. The number of RBC units per hospitalization decreased over time. Additional surveillance is needed to determine whether recent evidence regarding blood management has been incorporated into clinical practice for medical patients, as we strive to deliver optimal care to our veterans.

Corresponding author: Mary A.M. Rogers, PhD, MS, Dept. of Internal Medicine, Univ. of Michigan, 016-422W NCRC, Ann Arbor, MI 48109-2800, maryroge@umich.edu.

Funding/support: Department of Veterans Affairs, Clinical Sciences Research & Development Service Merit Review Award (EPID-011-11S). The contents do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

Financial disclosures: None.

Author contributions: conception and design, MAMR, SS; analysis and interpretation of data, MAMR, JDB, DR, LK, SS; drafting of article, MAMR; critical revision of the article, MAMR, MTG, DR, LK, SS, VC; statistical expertise, MAMR, DR; obtaining of funding, MTG, SS, VC; administrative or technical support, MTG, LK, SS, VC; collection and assembly of data, JDB, LK.

We thank Dr. Berse and colleagues for their correspondence about our paper.^1,2 We are pleased they agreed with our conclusion: Thrombophilia testing has limited clinical utility in most inpatient settings.

Berse and colleagues critiqued details of our methodology in calculating payer cost, including how we estimated the number of Medicare claims for thrombophilia testing. We estimated that there were at least 280,000 Medicare claims in 2014 using CodeMap® (Wheaton Partners, LLC, Schaumburg, IL), a dataset of utilization data from the Physician Supplier Procedure Summary Master File from all Medicare Part B carriers.³ This estimate was similar to that reported in a previous publication.⁴

Disclosure

Nothing to report.

We thank Dr. Berse and colleagues for their correspondence about our paper.^1,2 We are pleased they agreed with our conclusion: Thrombophilia testing has limited clinical utility in most inpatient settings.

Berse and colleagues critiqued details of our methodology in calculating payer cost, including how we estimated the number of Medicare claims for thrombophilia testing. We estimated that there were at least 280,000 Medicare claims in 2014 using CodeMap® (Wheaton Partners, LLC, Schaumburg, IL), a dataset of utilization data from the Physician Supplier Procedure Summary Master File from all Medicare Part B carriers.³ This estimate was similar to that reported in a previous publication.⁴

Disclosure

Nothing to report.

We thank Dr. Berse and colleagues for their correspondence about our paper.^1,2 We are pleased they agreed with our conclusion: Thrombophilia testing has limited clinical utility in most inpatient settings.

Berse and colleagues critiqued details of our methodology in calculating payer cost, including how we estimated the number of Medicare claims for thrombophilia testing. We estimated that there were at least 280,000 Medicare claims in 2014 using CodeMap® (Wheaton Partners, LLC, Schaumburg, IL), a dataset of utilization data from the Physician Supplier Procedure Summary Master File from all Medicare Part B carriers.³ This estimate was similar to that reported in a previous publication.⁴

Disclosure

Nothing to report.

Central venous catheter (CVC) placement is commonly performed in emergency and critical care settings for parenteral access, central monitoring, and hemodialysis. Although potentially lifesaving CVC insertion is associated with immediate risks including injury to nerves, vessels, and lungs.^1-3 These “insertion-related complications” are of particular interest for several reasons. First, the frequency of such complications varies widely, with published rates between 1.4% and 33.2%.^2-7 Reasons for such variation include differences in study definitions of complications (eg, pneumothorax and tip position),^2,5 setting of CVC placement (eg, intensive care unit [ICU] vs emergency room), timing of placement (eg, elective vs emergent), differences in technique, and type of operator (eg, experienced vs learner). Thus, the precise incidence of such events in modern-day training settings with use of ultrasound guidance remains uncertain. Second, mechanical complications might be preventable with adequate training and supervision. Indeed, studies using simulation-based mastery techniques have demonstrated a reduction in rates of complications following intensive training.⁸ Finally, understanding risk factors associated with insertion complications might inform preventative strategies and improve patient safety.^9-11

Few studies to date have examined trainees’ perceptions on CVC training, experience, supervision, and ability to recognize and prevent mechanical complications. While research investigating effects of simulation training has accumulated, most focus on successful completion of the procedure or individual procedural steps with little emphasis on operator perceptions.^12-14 In addition, while multiple studies have shown that unsuccessful line attempts are a risk factor for CVC complications,^3,4,7,15 there is very little known about trainee behavior and perceptions regarding unsuccessful line placement. CVC simulation trainings often assume successful completion of the procedure and do not address the crucial postprocedure steps that should be undertaken if a procedure is unsuccessful. For these reasons, we developed a survey to specifically examine trainee experience with CVC placement, supervision, postprocedural behavior, and attitudes regarding unsuccessful line placement.

Therefore, we designed a study with 2 specific goals: The first is to perform a contemporary analysis of CVC mechanical complication rate at an academic teaching institution and identify potential risk factors associated with these complications. Second, we sought to determine trainee perceptions regarding CVC complication experience, prevention, procedural supervision, and perceptions surrounding unsuccessful line placement.

Design and Setting

We conducted a single-center retrospective review of nontunneled acute CVC procedures between June 1, 2014, and May 1, 2015, at the University of Michigan Health System (UMHS). UMHS is a tertiary care referral center with over 900 inpatient beds, including 99 ICU beds.

All residents in internal medicine, surgery, anesthesia, and emergency medicine receive mandatory education in CVC placement that includes an online training module and simulation-based training with competency assessment. Use of real-time ultrasound guidance is considered the standard of care for CVC placement.

Data Collection

Inpatient procedure notes were electronically searched for terms indicating CVC placement. This was performed by using our hospital’s Data Office for Clinical and Translational Research using the Electronic Medical Record Search Engine tool. Please see the supplemental materials for the full list of search terms. We electronically extracted data, including date of procedure, gender, and most recent body mass index (BMI), within 1 year prior to note. Acute Physiology and Chronic Health Evaluation III (APACHE III) data are tracked for all patients on admission to ICU; this was collected when available. Charts were then manually reviewed to collect additional data, including international normalized ratio (INR), platelet count, lactate level on the day of CVC placement, anticoagulant use (actively prescribed coumadin, therapeutic enoxaparin, therapeutic unfractionated heparin, or direct oral anticoagulant), ventilator or noninvasive positive pressure ventilation (NIPPV) at time of CVC placement, and vasopressor requirement within 24 hours of CVC placement. The procedure note was reviewed to gather information about site of CVC placement, size and type of catheter, number of attempts, procedural success, training level of the operator, and attending presence. Small bore CVCs were defined as 7 French (Fr) or lower. Large bore CVCs were defined as >7 Fr; this includes dialysis catheters, Cordis catheters (Cordis, Fremont, CA), and cooling catheters. The times of the procedure note and postprocedure chest x-ray (CXR) were recorded, including whether the CVC was placed on a weekend (Friday 7 pm to Sunday at midnight) or weekday.

Primary Outcome

The primary outcome was the rate of severe mechanical complications related to CVC placement. Similar to prior studies,² we defined severe mechanical complications as arterial placement of dilator or catheter, hemothorax, pneumothorax, cerebral ischemia, patient death (related to procedure), significant hematoma, or vascular injury (defined as complication requiring expert consultation or blood product transfusion). We did not require a lower limit on blood transfusion. We considered pneumothorax a complication regardless of whether chest tube intervention was performed, as pneumothorax subjects the patient to additional tests (eg, serial CXRs) and sometimes symptoms (shortness of breath, pain, anxiety) regardless of whether or not a chest tube was required. Complications were confirmed by a direct review of procedure notes, progress notes, discharge summaries, and imaging studies.

Trainee Survey

A survey was electronically disseminated to all internal medicine and medicine-pediatric residents to inquire about CVC experiences, including time spent in the medical ICU, number of CVCs performed, postprocedure behavior for both failed and successful CVCs, and supervision experience and attitudes. Please see supplemental materials for full survey contents.

Statistical Methods

Descriptive statistics (percentage) were used to summarize data. Continuous and categorical variables were compared using Student t tests and chi-square tests, respectively. All analyses were performed using SAS 9.3 (SAS Institute, Cary, NC).

Ethical and Regulatory Oversight

The study was deemed exempt by the University of Michigan Institutional Review Board (HUM00100549) as data collection was part of a quality improvement effort.

Demographics and Characteristics of Device Insertion

Between June 1, 2014, and May 1, 2015, 730 CVC procedure notes were reviewed (Table 1). The mean age of the study population was 58.9 years, and 41.6% (n = 304) were female. BMI data were available in 400 patients without complications and 5 patients with complications; the average BMI was 31.5 kg/m². The APACHE III score was available for 442 patients without complications and 10 patients with complications; the average score was 86 (range 19-200). Most of the CVCs placed (n= 504, 69%) were small bore (<7 Fr). The majority of catheters were placed in the internal jugular (IJ) position (n = 525, 71.9%), followed by femoral (n = 144, 19.7%), subclavian (N = 57, 7.8%), and undocumented (n = 4, 0.6%). Ninety-six percent (n = 699) of CVCs were successfully placed. Seventy-six percent (n = 558) of procedure notes included documentation of the number of CVC attempts; of these, 85% documented 2 or fewer attempts. The majority of CVCs were placed by residents (n = 537, 73.9%), followed by fellows (N = 127, 17.5%) and attendings (n = 27, 3.7%). Attending supervision for all or key portions of CVC placement occurred 34.7% (n = 244) of the time overall and was lower for internal medicine trainees (n = 98/463, 21.2%) compared with surgical trainees (n = 73/127, 57.4%) or emergency medicine trainees (n = 62/96, 64.6%; P < 0.001). All successful IJ and subclavian CVCs except for 2 insertions (0.3%) had a postprocedure CXR. A minority of notes documented pressure transduction (4.5%) or blood gas analysis (0.2%) to confirm venous placement.

Mechanical Complications

The mechanical complications identified included pneumothorax (n = 5), bleeding requiring transfusion (n = 3), vascular injury requiring expert consultation or intervention (n = 3), stroke (n = 1), and death (n = 2). Vascular injuries included 1 neck hematoma with superinfection requiring antibiotics, 1 neck hematoma requiring otolaryngology and vascular surgery consultation, and 1 venous dissection of IJ vein requiring vascular surgery consultation. None of these cases required operative intervention. The stroke was caused by inadvertent CVC placement into the carotid artery. One patient experienced tension pneumothorax and died due to this complication; this death occurred after 3 failed left subclavian CVC attempts and an ultimately successful CVC placement into left IJ vein. Another death occurred immediately following unsuccessful Cordis placement. As no autopsy was performed, it is impossible to know if the cause of death was the line placement. However, it would be prudent to consider this as a CVC complication given the temporal relationship to line placement. Thus, the total number of patients who experienced severe mechanical complications was 14 out of 730 (1.92%).

Risk Factors for Mechanical Complications

Certain patient factors were more commonly associated with complications. For example, BMI was significantly lower in the group that experienced complications vs those that did not (25.7 vs 31.0 kg/m², P = 0.001). No other associations between demographic factors, including age (61.4 years vs 58.9 years, P = 0.57) or sex (57.1% male vs 41.3% female, P = 0.24), or admission APACHE III score (96 vs 86, P = 0.397) were noted. The mean INR, platelets, and lactate did not differ between the 2 groups. There was no difference between the use of vasopressors. Ventilator use (including endotracheal tube or NIPPV) was found to be significantly higher in the group that experienced mechanical complications (78.5% vs 65.9%, P = 0.001). Anticoagulation use was also associated with mechanical complications (28.6% vs 20.6%, P = 0.05); 3 patients on anticoagulation experienced significant hematomas. Mechanical complications were more common with subclavian location (21.4% vs 7.8%, P = 0.001); in all 3 cases involving subclavian CVC placement, the complication experienced was pneumothorax. The number of attempts significantly differed between the 2 groups, with an average of 1.5 attempts in the group without complications and 2.2 attempts in the group that experienced complications (P = 0.02). Additionally, rates of successful placement were lower among patients who experienced complications (78.6% vs 95.7%, P = 0.001).

With respect to operator characteristics, no significant difference between the levels of training was noted among those who experienced complications vs those who did not. Attending supervision was more frequent for the group that experienced complications (61.5% vs 34.2%, P = 0.04). There was no significant difference in complication rate according to the first vs the second half of the academic year (0.4% vs 0.3% per month, P = 0.30) or CVC placement during the day vs night (1.9% vs 2.0%, P = 0.97). A trend toward more complications in CVCs placed over the weekend compared to a weekday was observed (2.80% vs 1.23%, P = 0.125).

Unsuccessful CVCs

There were 30 documented unsuccessful CVC procedures, representing 4.1% of all procedures. Of these, 3 procedures had complications; these included 2 pneumothoraxes (1 leading to death) and 1 unexplained death. Twenty-four of the unsuccessful CVC attempts were in either the subclavian or IJ location; of these, 5 (21%) did not have a postprocedure CXR obtained.

Survey Results

The survey was completed by 103 out of 166 internal medicine residents (62% response rate). Of these, 55% (n = 57) reported having performed 5 or more CVCs, and 14% (n = 14) had performed more than 15 CVCs.

All respondents who had performed at least 1 CVC (n = 80) were asked about their perceptions regarding attending supervision. Eighty-one percent (n = 65/80) responded that they have never been directly supervised by an attending during CVC placement, while 16% (n = 13/80) reported being supervised less than 25% of the time. Most (n = 53/75, 71%) did not feel that attending supervision affected their performance, while 21% (n = 16/75) felt it affected performance negatively, and only 8% (n = 6/75) stated it affected performance positively. Nineteen percent (n = 15/80) indicated that they prefer more supervision by attendings, while 35% (n = 28/80) did not wish for more attending supervision, and 46% (n = 37/80) were indifferent.

We performed a contemporary analysis of CVC placement at an academic tertiary care center and observed a rate of severe mechanical complications of 1.9%. This rate is within previously described acceptable thresholds.¹⁶ Our study adds to the literature by identifying several important risk factors for development of mechanical complications. We confirm many risk factors that have been noted historically, such as subclavian line location,^2,3 attending supervision,³ low BMI,⁴ number of CVC attempts, and unsuccessful CVC placement.^3,4,7,15 We identified several unique risk factors, including systemic anticoagulation as well as ventilator use. Lastly, we identified unexpected deficits in trainee knowledge surrounding management of failed CVCs and negative attitudes regarding attending supervision.

Most existing literature evaluated risk factors for CVC complication prior to routine ultrasound use;^3-5,7,15 surprisingly, it appears that severe mechanical complications do not differ dramatically in the real-time ultrasound era. Eisen et al.³ prospectively studied CVC placement at an academic medical center and found a severe mechanical complication rate (as defined in our paper) of 1.9% due to pneumothorax (1.3%), hemothorax (0.3%), and death (0.3%).We would expect the number of complications to decrease in the postultrasound era, and indeed it appears that pneumothoraces have decreased likely due to ultrasound guidance and decrease in subclavian location. However, in contrast, rates of significant hematomas and bleeding are higher in our study. Although we are unable to state why this may be the case, increasing use of anticoagulation in the general population might explain this finding.¹⁷ For instance, of the 6 patients who experienced hematomas or vascular injuries in our study, 3 were on anticoagulation at the time of CVC placement.

Interestingly, time of academic year of CVC placement and level of training were not correlated with an increased risk of complications, nor was time of day of CVC placement. In contrast, Merrer et al.showed that CVC insertion during nighttime was significantly associated with increased mechanical complications (odds ratio 2.06, 95% confidence interval, 1.04-4.08;,P = 0.03).⁵ This difference may be attributable to the fact that most of our ICUs now have a night float system rather than a more traditional 24-hour call model; therefore, trainees are less likely to be sleep deprived during CVC placement at night.

Severity of illness did not appear to significantly affect mechanical complication rates based on similar APACHE scores between the 2 groups. In addition, other indicators of illness severity (vasopressor use or lactate level) did not suggest that sicker patients may be more likely to experience mechanical complications than others. One could conjecture that perhaps sicker patients were more likely to have lines placed by more experienced trainees, although the present study design does not allow us to answer this question. Interestingly, ventilator use was associated with higher rates of complications. We cannot say definitively why this was the case; however, 1 contributing factor may be the physical constraints of placing the CVC around ventilator tubing.

Several unexpected findings surrounding attending supervision were noted: first, attending supervision appears to be significantly associated with increased complication rate, and second, trainees have negative perceptions regarding attending supervision. Eisen et al.showed a similar association between attending supervision and complication rate.³ It is possible that the increased complication rate is because sicker patients are more likely to have procedural supervision by attendings, attending physicians may be called to supervise when a CVC placement is not going as planned, or attendings may supervise more inexperienced operators. Reasons behind negative trainee attitudes surrounding supervision are unclear and literature on this topic is limited. This is an area that warrants further exploration in future studies.

Another unexpected finding is trainee practices regarding unsuccessful CVC placement; most trainees do not document failed procedures or order follow-up CXRs after unsuccessful CVC attempts. Given the higher risk of complications after unsuccessful CVCs, it is paramount that all physicians are trained to order postprocedure CXR to rule out pneumothorax or hemothorax. Furthermore, documentation of failed procedures is important for medical accuracy, transparency, and also hospital billing. It is unknown if these practices surrounding unsuccessful CVCs are institution-specific or more widespread. As far as we know, this is the first time that trainee practices regarding failed CVC placement have been published. Interestingly, while many current guidelines call attention to prevention, recognition, and management of central line-associated mechanical complications, specific recommendations about postprocedure behavior after failed CVC placement are not published.^9-11 We feel it is critical that institutions reflect on their own practices, especially given that unsuccessful CVCs are shown to be correlated with a significant increase in complication rate. At our own institution, we have initiated an educational component of central line training for medicine trainees specifically addressing failed central line attempts.

This study has several limitations, including a retrospective study design at a single institution. There was a low overall number of complications, which reduced our ability to detect risk factors for complications and did not allow us to perform multivariable adjustment. Other limitations are that only documented CVC attempts were recorded and only those that met our search criteria. Lastly, not all notes contain information such as the number of attempts or peer supervision. Furthermore, the definition of CVC “attempt” is left to the operator’s discretion.

In conclusion, we observed a modern CVC mechanical complication rate of 1.9%. While the complication rate is similar to previous studies, there appear to be lower rates of pneumothorax and higher rates of bleeding complications. We also identified a deficit in trainee education regarding unsuccessful CVC placement; this is a novel finding and requires further investigation at other centers.

Disclosure: The authors have no conflicts of interest to report.

Central venous catheter (CVC) placement is commonly performed in emergency and critical care settings for parenteral access, central monitoring, and hemodialysis. Although potentially lifesaving CVC insertion is associated with immediate risks including injury to nerves, vessels, and lungs.^1-3 These “insertion-related complications” are of particular interest for several reasons. First, the frequency of such complications varies widely, with published rates between 1.4% and 33.2%.^2-7 Reasons for such variation include differences in study definitions of complications (eg, pneumothorax and tip position),^2,5 setting of CVC placement (eg, intensive care unit [ICU] vs emergency room), timing of placement (eg, elective vs emergent), differences in technique, and type of operator (eg, experienced vs learner). Thus, the precise incidence of such events in modern-day training settings with use of ultrasound guidance remains uncertain. Second, mechanical complications might be preventable with adequate training and supervision. Indeed, studies using simulation-based mastery techniques have demonstrated a reduction in rates of complications following intensive training.⁸ Finally, understanding risk factors associated with insertion complications might inform preventative strategies and improve patient safety.^9-11

Few studies to date have examined trainees’ perceptions on CVC training, experience, supervision, and ability to recognize and prevent mechanical complications. While research investigating effects of simulation training has accumulated, most focus on successful completion of the procedure or individual procedural steps with little emphasis on operator perceptions.^12-14 In addition, while multiple studies have shown that unsuccessful line attempts are a risk factor for CVC complications,^3,4,7,15 there is very little known about trainee behavior and perceptions regarding unsuccessful line placement. CVC simulation trainings often assume successful completion of the procedure and do not address the crucial postprocedure steps that should be undertaken if a procedure is unsuccessful. For these reasons, we developed a survey to specifically examine trainee experience with CVC placement, supervision, postprocedural behavior, and attitudes regarding unsuccessful line placement.

Therefore, we designed a study with 2 specific goals: The first is to perform a contemporary analysis of CVC mechanical complication rate at an academic teaching institution and identify potential risk factors associated with these complications. Second, we sought to determine trainee perceptions regarding CVC complication experience, prevention, procedural supervision, and perceptions surrounding unsuccessful line placement.

Design and Setting

We conducted a single-center retrospective review of nontunneled acute CVC procedures between June 1, 2014, and May 1, 2015, at the University of Michigan Health System (UMHS). UMHS is a tertiary care referral center with over 900 inpatient beds, including 99 ICU beds.

All residents in internal medicine, surgery, anesthesia, and emergency medicine receive mandatory education in CVC placement that includes an online training module and simulation-based training with competency assessment. Use of real-time ultrasound guidance is considered the standard of care for CVC placement.

Data Collection

Inpatient procedure notes were electronically searched for terms indicating CVC placement. This was performed by using our hospital’s Data Office for Clinical and Translational Research using the Electronic Medical Record Search Engine tool. Please see the supplemental materials for the full list of search terms. We electronically extracted data, including date of procedure, gender, and most recent body mass index (BMI), within 1 year prior to note. Acute Physiology and Chronic Health Evaluation III (APACHE III) data are tracked for all patients on admission to ICU; this was collected when available. Charts were then manually reviewed to collect additional data, including international normalized ratio (INR), platelet count, lactate level on the day of CVC placement, anticoagulant use (actively prescribed coumadin, therapeutic enoxaparin, therapeutic unfractionated heparin, or direct oral anticoagulant), ventilator or noninvasive positive pressure ventilation (NIPPV) at time of CVC placement, and vasopressor requirement within 24 hours of CVC placement. The procedure note was reviewed to gather information about site of CVC placement, size and type of catheter, number of attempts, procedural success, training level of the operator, and attending presence. Small bore CVCs were defined as 7 French (Fr) or lower. Large bore CVCs were defined as >7 Fr; this includes dialysis catheters, Cordis catheters (Cordis, Fremont, CA), and cooling catheters. The times of the procedure note and postprocedure chest x-ray (CXR) were recorded, including whether the CVC was placed on a weekend (Friday 7 pm to Sunday at midnight) or weekday.

Primary Outcome

The primary outcome was the rate of severe mechanical complications related to CVC placement. Similar to prior studies,² we defined severe mechanical complications as arterial placement of dilator or catheter, hemothorax, pneumothorax, cerebral ischemia, patient death (related to procedure), significant hematoma, or vascular injury (defined as complication requiring expert consultation or blood product transfusion). We did not require a lower limit on blood transfusion. We considered pneumothorax a complication regardless of whether chest tube intervention was performed, as pneumothorax subjects the patient to additional tests (eg, serial CXRs) and sometimes symptoms (shortness of breath, pain, anxiety) regardless of whether or not a chest tube was required. Complications were confirmed by a direct review of procedure notes, progress notes, discharge summaries, and imaging studies.

Trainee Survey

A survey was electronically disseminated to all internal medicine and medicine-pediatric residents to inquire about CVC experiences, including time spent in the medical ICU, number of CVCs performed, postprocedure behavior for both failed and successful CVCs, and supervision experience and attitudes. Please see supplemental materials for full survey contents.

Statistical Methods

Descriptive statistics (percentage) were used to summarize data. Continuous and categorical variables were compared using Student t tests and chi-square tests, respectively. All analyses were performed using SAS 9.3 (SAS Institute, Cary, NC).

Ethical and Regulatory Oversight

The study was deemed exempt by the University of Michigan Institutional Review Board (HUM00100549) as data collection was part of a quality improvement effort.

Demographics and Characteristics of Device Insertion

Between June 1, 2014, and May 1, 2015, 730 CVC procedure notes were reviewed (Table 1). The mean age of the study population was 58.9 years, and 41.6% (n = 304) were female. BMI data were available in 400 patients without complications and 5 patients with complications; the average BMI was 31.5 kg/m². The APACHE III score was available for 442 patients without complications and 10 patients with complications; the average score was 86 (range 19-200). Most of the CVCs placed (n= 504, 69%) were small bore (<7 Fr). The majority of catheters were placed in the internal jugular (IJ) position (n = 525, 71.9%), followed by femoral (n = 144, 19.7%), subclavian (N = 57, 7.8%), and undocumented (n = 4, 0.6%). Ninety-six percent (n = 699) of CVCs were successfully placed. Seventy-six percent (n = 558) of procedure notes included documentation of the number of CVC attempts; of these, 85% documented 2 or fewer attempts. The majority of CVCs were placed by residents (n = 537, 73.9%), followed by fellows (N = 127, 17.5%) and attendings (n = 27, 3.7%). Attending supervision for all or key portions of CVC placement occurred 34.7% (n = 244) of the time overall and was lower for internal medicine trainees (n = 98/463, 21.2%) compared with surgical trainees (n = 73/127, 57.4%) or emergency medicine trainees (n = 62/96, 64.6%; P < 0.001). All successful IJ and subclavian CVCs except for 2 insertions (0.3%) had a postprocedure CXR. A minority of notes documented pressure transduction (4.5%) or blood gas analysis (0.2%) to confirm venous placement.

Mechanical Complications

The mechanical complications identified included pneumothorax (n = 5), bleeding requiring transfusion (n = 3), vascular injury requiring expert consultation or intervention (n = 3), stroke (n = 1), and death (n = 2). Vascular injuries included 1 neck hematoma with superinfection requiring antibiotics, 1 neck hematoma requiring otolaryngology and vascular surgery consultation, and 1 venous dissection of IJ vein requiring vascular surgery consultation. None of these cases required operative intervention. The stroke was caused by inadvertent CVC placement into the carotid artery. One patient experienced tension pneumothorax and died due to this complication; this death occurred after 3 failed left subclavian CVC attempts and an ultimately successful CVC placement into left IJ vein. Another death occurred immediately following unsuccessful Cordis placement. As no autopsy was performed, it is impossible to know if the cause of death was the line placement. However, it would be prudent to consider this as a CVC complication given the temporal relationship to line placement. Thus, the total number of patients who experienced severe mechanical complications was 14 out of 730 (1.92%).

Risk Factors for Mechanical Complications

Certain patient factors were more commonly associated with complications. For example, BMI was significantly lower in the group that experienced complications vs those that did not (25.7 vs 31.0 kg/m², P = 0.001). No other associations between demographic factors, including age (61.4 years vs 58.9 years, P = 0.57) or sex (57.1% male vs 41.3% female, P = 0.24), or admission APACHE III score (96 vs 86, P = 0.397) were noted. The mean INR, platelets, and lactate did not differ between the 2 groups. There was no difference between the use of vasopressors. Ventilator use (including endotracheal tube or NIPPV) was found to be significantly higher in the group that experienced mechanical complications (78.5% vs 65.9%, P = 0.001). Anticoagulation use was also associated with mechanical complications (28.6% vs 20.6%, P = 0.05); 3 patients on anticoagulation experienced significant hematomas. Mechanical complications were more common with subclavian location (21.4% vs 7.8%, P = 0.001); in all 3 cases involving subclavian CVC placement, the complication experienced was pneumothorax. The number of attempts significantly differed between the 2 groups, with an average of 1.5 attempts in the group without complications and 2.2 attempts in the group that experienced complications (P = 0.02). Additionally, rates of successful placement were lower among patients who experienced complications (78.6% vs 95.7%, P = 0.001).

With respect to operator characteristics, no significant difference between the levels of training was noted among those who experienced complications vs those who did not. Attending supervision was more frequent for the group that experienced complications (61.5% vs 34.2%, P = 0.04). There was no significant difference in complication rate according to the first vs the second half of the academic year (0.4% vs 0.3% per month, P = 0.30) or CVC placement during the day vs night (1.9% vs 2.0%, P = 0.97). A trend toward more complications in CVCs placed over the weekend compared to a weekday was observed (2.80% vs 1.23%, P = 0.125).

Unsuccessful CVCs

There were 30 documented unsuccessful CVC procedures, representing 4.1% of all procedures. Of these, 3 procedures had complications; these included 2 pneumothoraxes (1 leading to death) and 1 unexplained death. Twenty-four of the unsuccessful CVC attempts were in either the subclavian or IJ location; of these, 5 (21%) did not have a postprocedure CXR obtained.

Survey Results

The survey was completed by 103 out of 166 internal medicine residents (62% response rate). Of these, 55% (n = 57) reported having performed 5 or more CVCs, and 14% (n = 14) had performed more than 15 CVCs.

All respondents who had performed at least 1 CVC (n = 80) were asked about their perceptions regarding attending supervision. Eighty-one percent (n = 65/80) responded that they have never been directly supervised by an attending during CVC placement, while 16% (n = 13/80) reported being supervised less than 25% of the time. Most (n = 53/75, 71%) did not feel that attending supervision affected their performance, while 21% (n = 16/75) felt it affected performance negatively, and only 8% (n = 6/75) stated it affected performance positively. Nineteen percent (n = 15/80) indicated that they prefer more supervision by attendings, while 35% (n = 28/80) did not wish for more attending supervision, and 46% (n = 37/80) were indifferent.

We performed a contemporary analysis of CVC placement at an academic tertiary care center and observed a rate of severe mechanical complications of 1.9%. This rate is within previously described acceptable thresholds.¹⁶ Our study adds to the literature by identifying several important risk factors for development of mechanical complications. We confirm many risk factors that have been noted historically, such as subclavian line location,^2,3 attending supervision,³ low BMI,⁴ number of CVC attempts, and unsuccessful CVC placement.^3,4,7,15 We identified several unique risk factors, including systemic anticoagulation as well as ventilator use. Lastly, we identified unexpected deficits in trainee knowledge surrounding management of failed CVCs and negative attitudes regarding attending supervision.

Most existing literature evaluated risk factors for CVC complication prior to routine ultrasound use;^3-5,7,15 surprisingly, it appears that severe mechanical complications do not differ dramatically in the real-time ultrasound era. Eisen et al.³ prospectively studied CVC placement at an academic medical center and found a severe mechanical complication rate (as defined in our paper) of 1.9% due to pneumothorax (1.3%), hemothorax (0.3%), and death (0.3%).We would expect the number of complications to decrease in the postultrasound era, and indeed it appears that pneumothoraces have decreased likely due to ultrasound guidance and decrease in subclavian location. However, in contrast, rates of significant hematomas and bleeding are higher in our study. Although we are unable to state why this may be the case, increasing use of anticoagulation in the general population might explain this finding.¹⁷ For instance, of the 6 patients who experienced hematomas or vascular injuries in our study, 3 were on anticoagulation at the time of CVC placement.

Interestingly, time of academic year of CVC placement and level of training were not correlated with an increased risk of complications, nor was time of day of CVC placement. In contrast, Merrer et al.showed that CVC insertion during nighttime was significantly associated with increased mechanical complications (odds ratio 2.06, 95% confidence interval, 1.04-4.08;,P = 0.03).⁵ This difference may be attributable to the fact that most of our ICUs now have a night float system rather than a more traditional 24-hour call model; therefore, trainees are less likely to be sleep deprived during CVC placement at night.

Severity of illness did not appear to significantly affect mechanical complication rates based on similar APACHE scores between the 2 groups. In addition, other indicators of illness severity (vasopressor use or lactate level) did not suggest that sicker patients may be more likely to experience mechanical complications than others. One could conjecture that perhaps sicker patients were more likely to have lines placed by more experienced trainees, although the present study design does not allow us to answer this question. Interestingly, ventilator use was associated with higher rates of complications. We cannot say definitively why this was the case; however, 1 contributing factor may be the physical constraints of placing the CVC around ventilator tubing.

Several unexpected findings surrounding attending supervision were noted: first, attending supervision appears to be significantly associated with increased complication rate, and second, trainees have negative perceptions regarding attending supervision. Eisen et al.showed a similar association between attending supervision and complication rate.³ It is possible that the increased complication rate is because sicker patients are more likely to have procedural supervision by attendings, attending physicians may be called to supervise when a CVC placement is not going as planned, or attendings may supervise more inexperienced operators. Reasons behind negative trainee attitudes surrounding supervision are unclear and literature on this topic is limited. This is an area that warrants further exploration in future studies.

Another unexpected finding is trainee practices regarding unsuccessful CVC placement; most trainees do not document failed procedures or order follow-up CXRs after unsuccessful CVC attempts. Given the higher risk of complications after unsuccessful CVCs, it is paramount that all physicians are trained to order postprocedure CXR to rule out pneumothorax or hemothorax. Furthermore, documentation of failed procedures is important for medical accuracy, transparency, and also hospital billing. It is unknown if these practices surrounding unsuccessful CVCs are institution-specific or more widespread. As far as we know, this is the first time that trainee practices regarding failed CVC placement have been published. Interestingly, while many current guidelines call attention to prevention, recognition, and management of central line-associated mechanical complications, specific recommendations about postprocedure behavior after failed CVC placement are not published.^9-11 We feel it is critical that institutions reflect on their own practices, especially given that unsuccessful CVCs are shown to be correlated with a significant increase in complication rate. At our own institution, we have initiated an educational component of central line training for medicine trainees specifically addressing failed central line attempts.

This study has several limitations, including a retrospective study design at a single institution. There was a low overall number of complications, which reduced our ability to detect risk factors for complications and did not allow us to perform multivariable adjustment. Other limitations are that only documented CVC attempts were recorded and only those that met our search criteria. Lastly, not all notes contain information such as the number of attempts or peer supervision. Furthermore, the definition of CVC “attempt” is left to the operator’s discretion.

In conclusion, we observed a modern CVC mechanical complication rate of 1.9%. While the complication rate is similar to previous studies, there appear to be lower rates of pneumothorax and higher rates of bleeding complications. We also identified a deficit in trainee education regarding unsuccessful CVC placement; this is a novel finding and requires further investigation at other centers.

Disclosure: The authors have no conflicts of interest to report.

Central venous catheter (CVC) placement is commonly performed in emergency and critical care settings for parenteral access, central monitoring, and hemodialysis. Although potentially lifesaving CVC insertion is associated with immediate risks including injury to nerves, vessels, and lungs.^1-3 These “insertion-related complications” are of particular interest for several reasons. First, the frequency of such complications varies widely, with published rates between 1.4% and 33.2%.^2-7 Reasons for such variation include differences in study definitions of complications (eg, pneumothorax and tip position),^2,5 setting of CVC placement (eg, intensive care unit [ICU] vs emergency room), timing of placement (eg, elective vs emergent), differences in technique, and type of operator (eg, experienced vs learner). Thus, the precise incidence of such events in modern-day training settings with use of ultrasound guidance remains uncertain. Second, mechanical complications might be preventable with adequate training and supervision. Indeed, studies using simulation-based mastery techniques have demonstrated a reduction in rates of complications following intensive training.⁸ Finally, understanding risk factors associated with insertion complications might inform preventative strategies and improve patient safety.^9-11

Few studies to date have examined trainees’ perceptions on CVC training, experience, supervision, and ability to recognize and prevent mechanical complications. While research investigating effects of simulation training has accumulated, most focus on successful completion of the procedure or individual procedural steps with little emphasis on operator perceptions.^12-14 In addition, while multiple studies have shown that unsuccessful line attempts are a risk factor for CVC complications,^3,4,7,15 there is very little known about trainee behavior and perceptions regarding unsuccessful line placement. CVC simulation trainings often assume successful completion of the procedure and do not address the crucial postprocedure steps that should be undertaken if a procedure is unsuccessful. For these reasons, we developed a survey to specifically examine trainee experience with CVC placement, supervision, postprocedural behavior, and attitudes regarding unsuccessful line placement.

Therefore, we designed a study with 2 specific goals: The first is to perform a contemporary analysis of CVC mechanical complication rate at an academic teaching institution and identify potential risk factors associated with these complications. Second, we sought to determine trainee perceptions regarding CVC complication experience, prevention, procedural supervision, and perceptions surrounding unsuccessful line placement.

Design and Setting

We conducted a single-center retrospective review of nontunneled acute CVC procedures between June 1, 2014, and May 1, 2015, at the University of Michigan Health System (UMHS). UMHS is a tertiary care referral center with over 900 inpatient beds, including 99 ICU beds.

All residents in internal medicine, surgery, anesthesia, and emergency medicine receive mandatory education in CVC placement that includes an online training module and simulation-based training with competency assessment. Use of real-time ultrasound guidance is considered the standard of care for CVC placement.

Data Collection

Inpatient procedure notes were electronically searched for terms indicating CVC placement. This was performed by using our hospital’s Data Office for Clinical and Translational Research using the Electronic Medical Record Search Engine tool. Please see the supplemental materials for the full list of search terms. We electronically extracted data, including date of procedure, gender, and most recent body mass index (BMI), within 1 year prior to note. Acute Physiology and Chronic Health Evaluation III (APACHE III) data are tracked for all patients on admission to ICU; this was collected when available. Charts were then manually reviewed to collect additional data, including international normalized ratio (INR), platelet count, lactate level on the day of CVC placement, anticoagulant use (actively prescribed coumadin, therapeutic enoxaparin, therapeutic unfractionated heparin, or direct oral anticoagulant), ventilator or noninvasive positive pressure ventilation (NIPPV) at time of CVC placement, and vasopressor requirement within 24 hours of CVC placement. The procedure note was reviewed to gather information about site of CVC placement, size and type of catheter, number of attempts, procedural success, training level of the operator, and attending presence. Small bore CVCs were defined as 7 French (Fr) or lower. Large bore CVCs were defined as >7 Fr; this includes dialysis catheters, Cordis catheters (Cordis, Fremont, CA), and cooling catheters. The times of the procedure note and postprocedure chest x-ray (CXR) were recorded, including whether the CVC was placed on a weekend (Friday 7 pm to Sunday at midnight) or weekday.

Primary Outcome

The primary outcome was the rate of severe mechanical complications related to CVC placement. Similar to prior studies,² we defined severe mechanical complications as arterial placement of dilator or catheter, hemothorax, pneumothorax, cerebral ischemia, patient death (related to procedure), significant hematoma, or vascular injury (defined as complication requiring expert consultation or blood product transfusion). We did not require a lower limit on blood transfusion. We considered pneumothorax a complication regardless of whether chest tube intervention was performed, as pneumothorax subjects the patient to additional tests (eg, serial CXRs) and sometimes symptoms (shortness of breath, pain, anxiety) regardless of whether or not a chest tube was required. Complications were confirmed by a direct review of procedure notes, progress notes, discharge summaries, and imaging studies.

Trainee Survey

A survey was electronically disseminated to all internal medicine and medicine-pediatric residents to inquire about CVC experiences, including time spent in the medical ICU, number of CVCs performed, postprocedure behavior for both failed and successful CVCs, and supervision experience and attitudes. Please see supplemental materials for full survey contents.

Statistical Methods

Descriptive statistics (percentage) were used to summarize data. Continuous and categorical variables were compared using Student t tests and chi-square tests, respectively. All analyses were performed using SAS 9.3 (SAS Institute, Cary, NC).

Ethical and Regulatory Oversight

The study was deemed exempt by the University of Michigan Institutional Review Board (HUM00100549) as data collection was part of a quality improvement effort.

Demographics and Characteristics of Device Insertion

Between June 1, 2014, and May 1, 2015, 730 CVC procedure notes were reviewed (Table 1). The mean age of the study population was 58.9 years, and 41.6% (n = 304) were female. BMI data were available in 400 patients without complications and 5 patients with complications; the average BMI was 31.5 kg/m². The APACHE III score was available for 442 patients without complications and 10 patients with complications; the average score was 86 (range 19-200). Most of the CVCs placed (n= 504, 69%) were small bore (<7 Fr). The majority of catheters were placed in the internal jugular (IJ) position (n = 525, 71.9%), followed by femoral (n = 144, 19.7%), subclavian (N = 57, 7.8%), and undocumented (n = 4, 0.6%). Ninety-six percent (n = 699) of CVCs were successfully placed. Seventy-six percent (n = 558) of procedure notes included documentation of the number of CVC attempts; of these, 85% documented 2 or fewer attempts. The majority of CVCs were placed by residents (n = 537, 73.9%), followed by fellows (N = 127, 17.5%) and attendings (n = 27, 3.7%). Attending supervision for all or key portions of CVC placement occurred 34.7% (n = 244) of the time overall and was lower for internal medicine trainees (n = 98/463, 21.2%) compared with surgical trainees (n = 73/127, 57.4%) or emergency medicine trainees (n = 62/96, 64.6%; P < 0.001). All successful IJ and subclavian CVCs except for 2 insertions (0.3%) had a postprocedure CXR. A minority of notes documented pressure transduction (4.5%) or blood gas analysis (0.2%) to confirm venous placement.

Mechanical Complications

The mechanical complications identified included pneumothorax (n = 5), bleeding requiring transfusion (n = 3), vascular injury requiring expert consultation or intervention (n = 3), stroke (n = 1), and death (n = 2). Vascular injuries included 1 neck hematoma with superinfection requiring antibiotics, 1 neck hematoma requiring otolaryngology and vascular surgery consultation, and 1 venous dissection of IJ vein requiring vascular surgery consultation. None of these cases required operative intervention. The stroke was caused by inadvertent CVC placement into the carotid artery. One patient experienced tension pneumothorax and died due to this complication; this death occurred after 3 failed left subclavian CVC attempts and an ultimately successful CVC placement into left IJ vein. Another death occurred immediately following unsuccessful Cordis placement. As no autopsy was performed, it is impossible to know if the cause of death was the line placement. However, it would be prudent to consider this as a CVC complication given the temporal relationship to line placement. Thus, the total number of patients who experienced severe mechanical complications was 14 out of 730 (1.92%).

Risk Factors for Mechanical Complications

Certain patient factors were more commonly associated with complications. For example, BMI was significantly lower in the group that experienced complications vs those that did not (25.7 vs 31.0 kg/m², P = 0.001). No other associations between demographic factors, including age (61.4 years vs 58.9 years, P = 0.57) or sex (57.1% male vs 41.3% female, P = 0.24), or admission APACHE III score (96 vs 86, P = 0.397) were noted. The mean INR, platelets, and lactate did not differ between the 2 groups. There was no difference between the use of vasopressors. Ventilator use (including endotracheal tube or NIPPV) was found to be significantly higher in the group that experienced mechanical complications (78.5% vs 65.9%, P = 0.001). Anticoagulation use was also associated with mechanical complications (28.6% vs 20.6%, P = 0.05); 3 patients on anticoagulation experienced significant hematomas. Mechanical complications were more common with subclavian location (21.4% vs 7.8%, P = 0.001); in all 3 cases involving subclavian CVC placement, the complication experienced was pneumothorax. The number of attempts significantly differed between the 2 groups, with an average of 1.5 attempts in the group without complications and 2.2 attempts in the group that experienced complications (P = 0.02). Additionally, rates of successful placement were lower among patients who experienced complications (78.6% vs 95.7%, P = 0.001).

With respect to operator characteristics, no significant difference between the levels of training was noted among those who experienced complications vs those who did not. Attending supervision was more frequent for the group that experienced complications (61.5% vs 34.2%, P = 0.04). There was no significant difference in complication rate according to the first vs the second half of the academic year (0.4% vs 0.3% per month, P = 0.30) or CVC placement during the day vs night (1.9% vs 2.0%, P = 0.97). A trend toward more complications in CVCs placed over the weekend compared to a weekday was observed (2.80% vs 1.23%, P = 0.125).

Unsuccessful CVCs

There were 30 documented unsuccessful CVC procedures, representing 4.1% of all procedures. Of these, 3 procedures had complications; these included 2 pneumothoraxes (1 leading to death) and 1 unexplained death. Twenty-four of the unsuccessful CVC attempts were in either the subclavian or IJ location; of these, 5 (21%) did not have a postprocedure CXR obtained.

Survey Results

The survey was completed by 103 out of 166 internal medicine residents (62% response rate). Of these, 55% (n = 57) reported having performed 5 or more CVCs, and 14% (n = 14) had performed more than 15 CVCs.

All respondents who had performed at least 1 CVC (n = 80) were asked about their perceptions regarding attending supervision. Eighty-one percent (n = 65/80) responded that they have never been directly supervised by an attending during CVC placement, while 16% (n = 13/80) reported being supervised less than 25% of the time. Most (n = 53/75, 71%) did not feel that attending supervision affected their performance, while 21% (n = 16/75) felt it affected performance negatively, and only 8% (n = 6/75) stated it affected performance positively. Nineteen percent (n = 15/80) indicated that they prefer more supervision by attendings, while 35% (n = 28/80) did not wish for more attending supervision, and 46% (n = 37/80) were indifferent.

We performed a contemporary analysis of CVC placement at an academic tertiary care center and observed a rate of severe mechanical complications of 1.9%. This rate is within previously described acceptable thresholds.¹⁶ Our study adds to the literature by identifying several important risk factors for development of mechanical complications. We confirm many risk factors that have been noted historically, such as subclavian line location,^2,3 attending supervision,³ low BMI,⁴ number of CVC attempts, and unsuccessful CVC placement.^3,4,7,15 We identified several unique risk factors, including systemic anticoagulation as well as ventilator use. Lastly, we identified unexpected deficits in trainee knowledge surrounding management of failed CVCs and negative attitudes regarding attending supervision.

Most existing literature evaluated risk factors for CVC complication prior to routine ultrasound use;^3-5,7,15 surprisingly, it appears that severe mechanical complications do not differ dramatically in the real-time ultrasound era. Eisen et al.³ prospectively studied CVC placement at an academic medical center and found a severe mechanical complication rate (as defined in our paper) of 1.9% due to pneumothorax (1.3%), hemothorax (0.3%), and death (0.3%).We would expect the number of complications to decrease in the postultrasound era, and indeed it appears that pneumothoraces have decreased likely due to ultrasound guidance and decrease in subclavian location. However, in contrast, rates of significant hematomas and bleeding are higher in our study. Although we are unable to state why this may be the case, increasing use of anticoagulation in the general population might explain this finding.¹⁷ For instance, of the 6 patients who experienced hematomas or vascular injuries in our study, 3 were on anticoagulation at the time of CVC placement.

Interestingly, time of academic year of CVC placement and level of training were not correlated with an increased risk of complications, nor was time of day of CVC placement. In contrast, Merrer et al.showed that CVC insertion during nighttime was significantly associated with increased mechanical complications (odds ratio 2.06, 95% confidence interval, 1.04-4.08;,P = 0.03).⁵ This difference may be attributable to the fact that most of our ICUs now have a night float system rather than a more traditional 24-hour call model; therefore, trainees are less likely to be sleep deprived during CVC placement at night.

Severity of illness did not appear to significantly affect mechanical complication rates based on similar APACHE scores between the 2 groups. In addition, other indicators of illness severity (vasopressor use or lactate level) did not suggest that sicker patients may be more likely to experience mechanical complications than others. One could conjecture that perhaps sicker patients were more likely to have lines placed by more experienced trainees, although the present study design does not allow us to answer this question. Interestingly, ventilator use was associated with higher rates of complications. We cannot say definitively why this was the case; however, 1 contributing factor may be the physical constraints of placing the CVC around ventilator tubing.

Several unexpected findings surrounding attending supervision were noted: first, attending supervision appears to be significantly associated with increased complication rate, and second, trainees have negative perceptions regarding attending supervision. Eisen et al.showed a similar association between attending supervision and complication rate.³ It is possible that the increased complication rate is because sicker patients are more likely to have procedural supervision by attendings, attending physicians may be called to supervise when a CVC placement is not going as planned, or attendings may supervise more inexperienced operators. Reasons behind negative trainee attitudes surrounding supervision are unclear and literature on this topic is limited. This is an area that warrants further exploration in future studies.

Another unexpected finding is trainee practices regarding unsuccessful CVC placement; most trainees do not document failed procedures or order follow-up CXRs after unsuccessful CVC attempts. Given the higher risk of complications after unsuccessful CVCs, it is paramount that all physicians are trained to order postprocedure CXR to rule out pneumothorax or hemothorax. Furthermore, documentation of failed procedures is important for medical accuracy, transparency, and also hospital billing. It is unknown if these practices surrounding unsuccessful CVCs are institution-specific or more widespread. As far as we know, this is the first time that trainee practices regarding failed CVC placement have been published. Interestingly, while many current guidelines call attention to prevention, recognition, and management of central line-associated mechanical complications, specific recommendations about postprocedure behavior after failed CVC placement are not published.^9-11 We feel it is critical that institutions reflect on their own practices, especially given that unsuccessful CVCs are shown to be correlated with a significant increase in complication rate. At our own institution, we have initiated an educational component of central line training for medicine trainees specifically addressing failed central line attempts.

This study has several limitations, including a retrospective study design at a single institution. There was a low overall number of complications, which reduced our ability to detect risk factors for complications and did not allow us to perform multivariable adjustment. Other limitations are that only documented CVC attempts were recorded and only those that met our search criteria. Lastly, not all notes contain information such as the number of attempts or peer supervision. Furthermore, the definition of CVC “attempt” is left to the operator’s discretion.

In conclusion, we observed a modern CVC mechanical complication rate of 1.9%. While the complication rate is similar to previous studies, there appear to be lower rates of pneumothorax and higher rates of bleeding complications. We also identified a deficit in trainee education regarding unsuccessful CVC placement; this is a novel finding and requires further investigation at other centers.

Disclosure: The authors have no conflicts of interest to report.

Pleural effusion can occur in myriad conditions including infection, heart failure, liver disease, and cancer.¹ Consequently, physicians from many disciplines routinely encounter both inpatients and outpatients with this diagnosis. Often, evaluation and treatment require thoracentesis to obtain fluid for analysis or symptom relief.

Although historically performed at the bedside without imaging guidance or intraprocedural monitoring, thoracentesis performed in this fashion carries considerable risk of complications. In fact, it has 1 of the highest rates of iatrogenic pneumothorax among bedside procedures.² However, recent advances in practice and adoption of newer technologies have helped to mitigate risks associated with this procedure. These advances are relevant because approximately 50% of thoracenteses are still performed at the bedside.³ In this review, we aim to identify the most recent key practices that enhance the safety and the effectiveness of thoracentesis for practicing clinicians.

Information Sources and Search Strategy

With the assistance of a research librarian, we performed a systematic search of PubMed-indexed articles from January 1, 2000 to September 30, 2015. Articles were identified using search terms such as thoracentesis, pleural effusion, safety, medical error, adverse event, and ultrasound in combination with Boolean operators. Of note, as thoracentesis is indexed as a subgroup of paracentesis in PubMed, this term was also included to increase the sensitivity of the search. The full search strategy is available in the Appendix. Any references cited in this review outside of the date range of our search are provided only to give relevant background information or establish the origin of commonly performed practices.

Study Eligibility and Selection Criteria

Studies were included if they reported clinical aspects related to thoracentesis. We defined clinical aspects as those strategies that focused on operator training, procedural techniques, technology, management, or prevention of complications. Non-English language articles, animal studies, case reports, conference proceedings, and abstracts were excluded. As our intention was to focus on the contemporary advances related to thoracentesis performance, (eg, ultrasound [US]), our search was limited to studies published after the year 2000. Two authors, Drs. Schildhouse and Lai independently screened studies to determine inclusion, excluding studies with weak methodology, very small sample sizes, and those only tangentially related to our aim. Disagreements regarding study inclusion were resolved by consensus. Drs. Lai, Barsuk, and Mourad identified additional studies by hand review of reference lists and content experts (Figure 1).

Conceptual Framework

All selected articles were categorized by temporal relationship to thoracentesis as pre-, intra-, or postprocedure. Pre-procedural topics were those outcomes that had been identified and addressed before attempting thoracentesis, such as physician training or perceived risks of harm. Intraprocedural considerations included aspects such as use of bedside US, pleural manometry, and large-volume drainage. Finally, postprocedural factors were those related to evaluation after thoracentesis, such as follow-up imaging. This conceptual framework is outlined in Figure 2.

The PubMed search returned a total of 1170 manuscripts, of which 56 articles met inclusion criteria. Four additional articles were identified by experts and included in the study.^4-7 Therefore, 60 articles were identified and included in this review. Study designs included cohort studies, case control studies, systematic reviews, meta-analyses, narrative reviews, consensus guidelines, and randomized controlled trials. A summary of all included articles by topic can be found in the Table.
 

PRE-PROCEDURAL CONSIDERATIONS

Physician Training

Studies indicate that graduate medical education may not adequately prepare clinicians to perform thoracentesis.⁸ In fact, residents have the least exposure and confidence in performing thoracentesis when compared to other bedside procedures.^9,10 In 1 survey, 69% of medical trainees desired more exposure to procedures, and 98% felt that procedural skills were important to master.¹¹ Not surprisingly, then, graduating internal medicine residents perform poorly when assessed on a thoracentesis simulator.¹²

Supplemental training outside of residency is useful to develop and maintain skills for thoracentesis, such as simulation with direct observation in a zero-risk environment. In 1 study, “simulation-based mastery learning” combined an educational video presentation with repeated, deliberate practice on a simulator until procedural competence was acquired, over two 2-hour sessions. In this study, 40 third-year medicine residents demonstrated a 71% improvement in clinical skills performance after course completion, with 93% achieving a passing score. The remaining 7% also achieved passing scores with extra practice time.¹² Others have built upon the concept of simulation-based training. For instance, 2 studies suggest that use of a simulation-based curriculum improved both thoracentesis knowledge and performance skills in a 3-hour session.^13,14 Similarly, 1 prospective study reported that a half-day thoracentesis workshop using simulation and 1:1 direct observation successfully lowered pneumothorax rates from 8.6% to 1.8% in a group of practicing clinicians. Notably, additional interventions including use of bedside US, limiting operators to a focused group, and standardization of equipment were also a part of this quality improvement initiative.⁷ Although repetition is required to gain proficiency when using a simulator, performance and confidence appear to plateau with only 4 simulator trials. In medical students, improvements derived through simulator-based teaching were sustained when retested 6 months following training.¹⁵

An instrument to ensure competency is necessary, given variability in procedural experience among both new graduates and practicing physicians,. Our search did not identify any clinically validated tools that adequately assessed thoracentesis performance. However, some have been proposed¹⁶ and 1 validated in a simulation environment.¹² Regarding the incorporation of US for effusion markup, 1 validated tool used an 11-domain assessment covering knowledge of US machine manipulation, recognition of images with common pleural effusion characteristics, and performance of thoracic US with puncture-site marking on a simulator. When used on 22 participants, scores with the tool could reliably differentiate between novice, intermediate, and advanced groups (P < 0.0001).¹⁷

Patient Selection

Coagulopathies and Anticoagulation. Historically, the accepted cutoff for performing thoracentesis is an international normalized ratio (INR) less than 1.5 and a platelet count greater than 50,000/µL. McVay et al.¹⁸ first showed in 1991 that use of these cutoffs was associated with low rates of periprocedural bleeding, leading to endorsement in the British Thoracic Society (BTS) Pleural Disease Guideline 2010.¹⁹ Other recommendations include the 2012 Society for Interventional Radiology guidelines that endorse correction of an INR greater than 2, or platelets less than 50,000/µL, based almost exclusively on expert opinion.⁵

However, data suggest that thoracentesis may be safely performed outside these parameters. For instance, a prospective study of approximately 9000 thoracenteses over 12 years found that patients with an INR of 1.5-2.9 or platelets of 20,000 - 49,000/µL experienced rates of bleeding complications similar to those with normal values.²⁰ Similarly, a 2014 review²¹ found that the overall risk of hemorrhage during thoracentesis in the setting of moderate coagulopathy (defined as an INR of 1.5 - 3 or platelets of 25,000-50,000/µL), was not increased. In 1 retrospective study of more than 1000 procedures, no differences in hemorrhagic events were noted in patients with bleeding diatheses that received prophylactic fresh frozen plasma or platelets vs. those who did not.²² Of note, included studies used a variety of criteria to define a hemorrhagic complication, which included: an isolated 2 g/dL or more decrement in hemoglobin, presence of bloody fluid on repeat tap with associated hemoglobin decrement, rapid re-accumulation of fluid with a hemoglobin decrement, or transfusion of 2 units or more of whole blood.

Whether it is safe to perform thoracentesis on patients taking antiplatelet therapy is less well understood. Although data are limited, a few small-scale studies^23,24 suggest that hemorrhagic complications following thoracentesis in patients receiving clopidogrel are comparable to the general population. We found no compelling data regarding the safety of thoracentesis in the setting of direct oral anticoagulants, heparin, low-molecular weight heparin, or intravenous direct thrombin inhibitors. Current practice is to generally avoid thoracentesis while these therapeutic anticoagulants are used.

Invasive mechanical ventilation. Pleural effusion is common in patients in the intensive care unit, including those requiring mechanical ventilation.²⁵ Thoracentesis in this population is clinically important: fluid analysis in 1 study was shown to aid the diagnosis in 45% of cases and changes in treatment in 33%.²⁶ However, clinicians may be reluctant to perform thoracentesis on patients who require mechanical ventilation, given the perception of a greater risk of pneumothorax from positive pressure ventilation.

Despite this concern, a 2011 meta-analysis including 19 studies and more than 1100 patients revealed rates of pneumothorax and hemothorax comparable to nonventilated patients.²⁵ Furthermore, a 2015 prospective study that examined thoracentesis in 1377 mechanically ventilated patients revealed no difference in complication rates as well.²⁰ Therefore, evidence suggests that performance of thoracentesis in mechanically ventilated patients is not contraindicated.

Skin Disinfection and Antisepsis Precautions

The 2010 BTS guidelines list empyema and wound infection as possible complications of thoracentesis.¹⁹ However, no data regarding incidence are provided. Additionally, an alcohol-based skin cleanser (such as 2% chlorhexidine gluconate/70% isopropyl alcohol), along with sterile gloves, field, and dressing are suggested as precautionary measures.¹⁹ In 1 single-center registry of 2489 thoracenteses performed using alcohol or iodine-based antiseptic and sterile drapes, no postprocedure infections were identified.²⁷ Of note, we did not find other studies (including case reports) that reported either incidence or rate of infectious complications such as wound infection and empyema. In an era of modern skin antiseptics that have effectively reduced complications such as catheter-related bloodstream infection,²⁸ the incidence of this event is thus likely to be low.

INTRAPROCEDURAL CONSIDERATIONS

Use of Bedside Ultrasound

Portable US has particular advantages for evaluation of pleural effusion vs other imaging modalities. Compared with computerized tomography (CT), bedside US offers similar performance but is less costly, avoids both radiation exposure and need for patient transportation, and provides results instantaneously.^29,30 Compared to chest x-ray (CXR), US is more sensitive at detecting the presence, volume, and characteristics of pleural fluid^30,31 and can be up to 100% sensitive for effusions greater than 100 mL.²⁹ Furthermore, whereas CXR typically requires 200 mL of fluid to be present for detection of an effusion, US can reliably detect as little as 20 mL of fluid.²⁹ When US was used to confirm thoracentesis puncture sites in a study involving 30 physicians of varying experience and 67 consecutive patients, 15% of sites found by clinical exam were inaccurate (less than 10 mm fluid present), 10% were at high risk for organ puncture, and a suitable fluid pocket was found 54% of times when exam could not.⁴

A 2010 meta-analysis of 24 studies and 6605 thoracenteses estimated the overall rate of pneumothorax at 6%; however, procedures performed with US guidance were associated with a 70% reduced risk of this event (odds ratio, 0.30; 95% confidence interval, 0.20 - 0.70).³² In a 2014 randomized control trial of 160 patients that compared thoracentesis with US guidance for site marking vs no US use, 10 pneumothoraces occurred in the control group vs 1 in the US group (12.5% vs 1.25%, P = 0.009).³³ Similarly, another retrospective review of 445 consecutive patients with malignant effusions revealed a pneumothorax rate of 0.97% using US in real time during needle insertion compared to 8.89% for unguided thoracenteses (P < 0.0001).³⁴ Several other studies using US guidance for either site markup or in real time reported similar pneumothorax rates, ranging from 1.1% - 4.8%.^35-37 However, it is unclear if real-time US specifically provides an additive effect vs site marking alone, as no studies directly comparing the 2 methods were found.

Benefits of US also include a higher rate of procedural success, with 1 study demonstrating a 99% success rate when using US vs. 90% without (P = 0.030).³³ A larger volume of fluid removed has been observed with US use as well, and methods have been described using fluid-pocket depth to guide puncture site localization and maximize drainage.³⁸ Finally, US use for thoracentesis has been associated with lower costs and length of stay.^39,40

Intercostal Artery Localization

Although rare (incidence, 0.18%-2%^20,21,39), the occurrence of hemothorax following thoracentesis is potentially catastrophic. This serious complication is often caused by laceration of the intercostal artery (ICA) or 1 of its branches during needle insertion.⁴¹

While risk of injury is theoretically reduced by needle insertion superior to the rib, studies using cadaver dissection and 3D angiography show significant tortuosity of the ICA.^6,41-43 The degree of tortuosity is increased within 6 cm of the midline, in more cephalad rib spaces, and in the elderly (older than 60 years).^41-43 Furthermore, 1 cadaveric study also demonstrated the presence of arterial collaterals branching off the ICA at multiple intercostal spaces, ranging between 8 cm and 11 cm from the midline.⁴¹ This anatomic variability may explain why some have observed low complication and hemothorax rates with an extreme lateral approach.³⁵ Bedside US with color flow Doppler imaging has been used to identify the ICA, with 88% sensitivity compared to CT imaging while adding little to exam time.^44,45 Of note, a 37% drop in the rate of hemothorax was observed in 1 study with routine US guidance alone.³⁹

Pleural Pressure Monitoring and Large-Volume Thoracentesis

While normal intrapleural pressures are approximately -5 to -10 cm H₂O,⁴⁶ the presence of a pleural effusion creates a complex interaction between fluid, compressed lung, and chest wall that can increase these pressures.⁴⁷ During drainage of an effusion, pleural pressures may rapidly drop, provoking re-expansion pulmonary edema (REPE). While rare (0 -1%), clinically-diagnosed REPE is a serious complication that can lead to rapid respiratory failure and death.^20,48 REPE is postulated to be caused by increased capillary permeability resulting from inflammation, driven by rapid re-inflation of the lung when exposed to highly negative intrapleural pressures.^47,49

Measurement of intrapleural pressure using a water manometer during thoracentesis may minimize REPE by terminating fluid drainage when intrapleural pressure begins to drop rapidly.^50,51 A cutoff of -20 cm H₂O has been cited repeatedly as safe since being suggested by Light in 1980, but this is based on animal models.^50,52 In 1 prospective study of 185 thoracenteses in which manometry was performed, 15% of patients had intrapleural pressure drop to less than -20 cm H₂O (at which point the procedure was terminated) but suffered no REPE.⁵⁰

Manometry is valuable in the identification of an unexpandable or trapped lung when pleural pressures drop rapidly with only minimal fluid volume removal.^47,53 Other findings correlated with an unexpandable lung include a negative opening pressure⁴⁷ and large fluctuations in pressure during the respiratory cycle.⁵⁴

While development of symptoms (eg, chest pain, cough, or dyspnea) is often used as a surrogate, the correlation between intrapleural pressure and patient symptoms is inconsistent and not a reliable proxy.⁵⁵ One study found that 22% of patients with chest pain during thoracentesis had intrapleural pressures lower than -20 cm H₂O compared with 8.6% of asymptomatic patients,⁵⁶ but it is unclear if the association is causal.

Thoracentesis is often performed for symptomatic relief and removal of large fluid volume. However, it remains common to halt fluid removal after 1.5 L, a threshold endorsed by BTS.¹⁹ While some investigators have suggested that removal of 2 L or more of pleural fluid does not compromise safety,^57,58 a 4- to 5-fold rise in the risk of pneumothorax was noted in 2 studies.^20,59 when more than 1.5 L of fluid was removed. The majority of these may be related to pneumothorax ex vacuo, a condition in which fluid is drained from the chest, but the lung is unable to expand and fill the space (eg, “trapped lung”), resulting in a persistent pneumothorax. This condition generally does not require treatment.⁶⁰ When manometry is employed at 200-mL intervals with termination at an intrapleural pressure of less than 20 mm H₂O, drainage of 3 L or more has been reported with low rates of pneumothorax and very low rates of REPE.^50,51 However, whether this is cause and effect is unknown because REPE is rare, and more work is needed to determine the role of manometry for its prevention.

POSTPROCEDURAL CONSIDERATIONS

Postprocedure Imaging

Performing an upright CXR following thoracentesis is a practice that remains routinely done by many practitioners to monitor for complications. Such imaging was also endorsed by the American Thoracic Society guidelines.⁶¹ However, more recent data question the utility of this practice. Multiple studies have confirmed that post-thoracentesis CXR is unnecessary unless clinical suspicion for pneumothorax or REPE is present.^36,58,62,63 The BTS guidelines also advocate this approach.¹⁹ Interestingly, a potentially more effective way to screen for postprocedure complications is through bedside US, which has been shown to be more sensitive than CXR in detecting pneumothorax.⁶⁴ In 1 study of 185 patients, bedside US demonstrated a sensitivity of 88% and a specificity of 97% for diagnosing pneumothorax in patients with adequate quality scans, with positive and negative likelihood ratios of 55 and 0.17, respectively.⁶⁵

Thoracentesis remains a core procedural skill for hospitalists, critical care physicians, and emergency physicians. It is the foundational component when investigating and treating pleural effusions. When the most current training, techniques, and technology are used, data suggest this procedure is safe to perform at the bedside. Our review highlights these strategies and evaluates which aspects might be most applicable to clinical practice.

Our findings have several implications for those who perform this procedure. First, appropriate training is central to procedural safety, and both simulation and direct observation by procedural experts have been shown by multiple investigators to improve knowledge and skill. This training should integrate the use of US in performing a focused thoracic exam.

Second, recommendations regarding coagulopathy and a “safe cutoff” of an INR less than 1.5 or platelets greater than 50,000/µL had limited evidentiary support. Rather, multiple studies suggest no difference in bleeding risk following thoracentesis with an INR as high as 3.0 and platelets greater than 25,000/µL. Furthermore, prophylactic transfusion with fresh frozen plasma or platelets before thoracentesis did not alter bleeding risk and exposes patients to transfusion complications. Thus, routine use of this practice can no longer be recommended. Third, further research is needed to understand the bleeding risk for patients on antiplatelet medications, heparin products, and also direct oral anticoagulants, given the growing popularity in their use and the potential consequences of even temporary cessation. Regarding patients on mechanical ventilation, thoracentesis demonstrated no difference in complication rates vs. the general population, and its performance in this population is encouraged when clinically indicated.

Intraprocedural considerations include the use of bedside US. Due to multiple benefits including effusion characterization, puncture site localization, and significantly lower rates of pneumothorax, the standard of care should be to perform thoracentesis with US guidance. Both use of US to mark an effusion immediately prior to puncture or in real time during needle insertion demonstrated benefit; however, it is unclear if 1 method is superior because no direct comparison studies were found. Further work is needed to investigate this potential.

Our review suggests that the location and course of the ICA is variable, especially near the midline, in the elderly, and in higher intercostal spaces, leaving it vulnerable to laceration. We recommend physicians only attempt thoracentesis at least 6 cm lateral to the midline due to ICA tortuosity and, ideally, 12 cm lateral, to avoid the presence of collaterals. Although only 2 small-scale studies were found pertaining to the use of US in identifying the ICA, we encourage physicians to consider learning how to screen for its presence as a part of their routine thoracic US exam in the area underlying the planned puncture site.

Manometry is beneficial because it can diagnose a nonexpandable lung and allows for pleural pressure monitoring.^52,53 A simple U-shaped manometer can be constructed from intravenous tubing included in most thoracentesis kits, which adds little to overall procedure time. While low rates of REPE have been observed when terminating thoracentesis if pressures drop below -20 cm H₂O or chest pain develops, neither measure appears to have reliable predictive value, limiting clinical utility. Further work is required to determine if a “safe pressure cutoff” exists. In general, we recommend the use of manometry when a nonexpandable (trapped) lung is suspected, because large drops in intrapleural pressure, a negative opening pressure, and respiratory variation can help confirm the diagnosis and avoid pneumothorax ex vacuo or unnecessary procedures in the future. As this condition appears to be more common in the setting of larger effusions, use of manometry when large-volume thoracenteses are planned is also reasonable.

Postprocedurally, routine imaging after thoracentesis is not recommended unless there is objective concern for complication. When indicated, bedside US is better positioned for this role compared with CXR, because it is more sensitive in detecting pneumothorax, provides instantaneous results, and avoids radiation exposure.

Our review has limitations. First, we searched only for articles between defined time periods, restricted our search to a single database, and excluded non-English articles. This has the potential to introduce selection bias, as nonprimary articles that fall within our time restrictions may cite older studies that are outside our search range. To minimize this effect, we performed a critical review of all included studies, especially nonprimary articles. Second, despite the focus of our search strategy to identify any articles related to patient safety and adverse events, we cannot guarantee that all relevant articles for any particular complication or risk factor were captured given the lack of more specific search terms. Third, although we performed a systematic search of the literature, we did not perform a formal systematic review or formally grade included studies. As the goal of our review was to categorize and operationalize clinical aspects, this approach was necessary, and we acknowledge that the quality of studies is variable. Lastly, we aimed to generate clinical recommendations for physicians performing thoracentesis at the bedside; others reviewing this literature may find or emphasize different aspects relevant to practice outside this setting.

In conclusion, evaluation and treatment of pleural effusions with bedside thoracentesis is an important skill for physicians of many disciplines. The evidence presented in this review will help inform the process and ensure patient safety. Physicians should consider incorporating these recommendations into their practice.

Acknowledgments

The authors thank Whitney Townsend, MLIS, health sciences informationist, for assistance with serial literature searches.

Disclosure

Nothing to report.

Pleural effusion can occur in myriad conditions including infection, heart failure, liver disease, and cancer.¹ Consequently, physicians from many disciplines routinely encounter both inpatients and outpatients with this diagnosis. Often, evaluation and treatment require thoracentesis to obtain fluid for analysis or symptom relief.

Although historically performed at the bedside without imaging guidance or intraprocedural monitoring, thoracentesis performed in this fashion carries considerable risk of complications. In fact, it has 1 of the highest rates of iatrogenic pneumothorax among bedside procedures.² However, recent advances in practice and adoption of newer technologies have helped to mitigate risks associated with this procedure. These advances are relevant because approximately 50% of thoracenteses are still performed at the bedside.³ In this review, we aim to identify the most recent key practices that enhance the safety and the effectiveness of thoracentesis for practicing clinicians.

Information Sources and Search Strategy

With the assistance of a research librarian, we performed a systematic search of PubMed-indexed articles from January 1, 2000 to September 30, 2015. Articles were identified using search terms such as thoracentesis, pleural effusion, safety, medical error, adverse event, and ultrasound in combination with Boolean operators. Of note, as thoracentesis is indexed as a subgroup of paracentesis in PubMed, this term was also included to increase the sensitivity of the search. The full search strategy is available in the Appendix. Any references cited in this review outside of the date range of our search are provided only to give relevant background information or establish the origin of commonly performed practices.

Study Eligibility and Selection Criteria

Studies were included if they reported clinical aspects related to thoracentesis. We defined clinical aspects as those strategies that focused on operator training, procedural techniques, technology, management, or prevention of complications. Non-English language articles, animal studies, case reports, conference proceedings, and abstracts were excluded. As our intention was to focus on the contemporary advances related to thoracentesis performance, (eg, ultrasound [US]), our search was limited to studies published after the year 2000. Two authors, Drs. Schildhouse and Lai independently screened studies to determine inclusion, excluding studies with weak methodology, very small sample sizes, and those only tangentially related to our aim. Disagreements regarding study inclusion were resolved by consensus. Drs. Lai, Barsuk, and Mourad identified additional studies by hand review of reference lists and content experts (Figure 1).

Conceptual Framework

All selected articles were categorized by temporal relationship to thoracentesis as pre-, intra-, or postprocedure. Pre-procedural topics were those outcomes that had been identified and addressed before attempting thoracentesis, such as physician training or perceived risks of harm. Intraprocedural considerations included aspects such as use of bedside US, pleural manometry, and large-volume drainage. Finally, postprocedural factors were those related to evaluation after thoracentesis, such as follow-up imaging. This conceptual framework is outlined in Figure 2.

The PubMed search returned a total of 1170 manuscripts, of which 56 articles met inclusion criteria. Four additional articles were identified by experts and included in the study.^4-7 Therefore, 60 articles were identified and included in this review. Study designs included cohort studies, case control studies, systematic reviews, meta-analyses, narrative reviews, consensus guidelines, and randomized controlled trials. A summary of all included articles by topic can be found in the Table.
 

PRE-PROCEDURAL CONSIDERATIONS

Physician Training

Studies indicate that graduate medical education may not adequately prepare clinicians to perform thoracentesis.⁸ In fact, residents have the least exposure and confidence in performing thoracentesis when compared to other bedside procedures.^9,10 In 1 survey, 69% of medical trainees desired more exposure to procedures, and 98% felt that procedural skills were important to master.¹¹ Not surprisingly, then, graduating internal medicine residents perform poorly when assessed on a thoracentesis simulator.¹²

Supplemental training outside of residency is useful to develop and maintain skills for thoracentesis, such as simulation with direct observation in a zero-risk environment. In 1 study, “simulation-based mastery learning” combined an educational video presentation with repeated, deliberate practice on a simulator until procedural competence was acquired, over two 2-hour sessions. In this study, 40 third-year medicine residents demonstrated a 71% improvement in clinical skills performance after course completion, with 93% achieving a passing score. The remaining 7% also achieved passing scores with extra practice time.¹² Others have built upon the concept of simulation-based training. For instance, 2 studies suggest that use of a simulation-based curriculum improved both thoracentesis knowledge and performance skills in a 3-hour session.^13,14 Similarly, 1 prospective study reported that a half-day thoracentesis workshop using simulation and 1:1 direct observation successfully lowered pneumothorax rates from 8.6% to 1.8% in a group of practicing clinicians. Notably, additional interventions including use of bedside US, limiting operators to a focused group, and standardization of equipment were also a part of this quality improvement initiative.⁷ Although repetition is required to gain proficiency when using a simulator, performance and confidence appear to plateau with only 4 simulator trials. In medical students, improvements derived through simulator-based teaching were sustained when retested 6 months following training.¹⁵

An instrument to ensure competency is necessary, given variability in procedural experience among both new graduates and practicing physicians,. Our search did not identify any clinically validated tools that adequately assessed thoracentesis performance. However, some have been proposed¹⁶ and 1 validated in a simulation environment.¹² Regarding the incorporation of US for effusion markup, 1 validated tool used an 11-domain assessment covering knowledge of US machine manipulation, recognition of images with common pleural effusion characteristics, and performance of thoracic US with puncture-site marking on a simulator. When used on 22 participants, scores with the tool could reliably differentiate between novice, intermediate, and advanced groups (P < 0.0001).¹⁷

Patient Selection

Coagulopathies and Anticoagulation. Historically, the accepted cutoff for performing thoracentesis is an international normalized ratio (INR) less than 1.5 and a platelet count greater than 50,000/µL. McVay et al.¹⁸ first showed in 1991 that use of these cutoffs was associated with low rates of periprocedural bleeding, leading to endorsement in the British Thoracic Society (BTS) Pleural Disease Guideline 2010.¹⁹ Other recommendations include the 2012 Society for Interventional Radiology guidelines that endorse correction of an INR greater than 2, or platelets less than 50,000/µL, based almost exclusively on expert opinion.⁵

However, data suggest that thoracentesis may be safely performed outside these parameters. For instance, a prospective study of approximately 9000 thoracenteses over 12 years found that patients with an INR of 1.5-2.9 or platelets of 20,000 - 49,000/µL experienced rates of bleeding complications similar to those with normal values.²⁰ Similarly, a 2014 review²¹ found that the overall risk of hemorrhage during thoracentesis in the setting of moderate coagulopathy (defined as an INR of 1.5 - 3 or platelets of 25,000-50,000/µL), was not increased. In 1 retrospective study of more than 1000 procedures, no differences in hemorrhagic events were noted in patients with bleeding diatheses that received prophylactic fresh frozen plasma or platelets vs. those who did not.²² Of note, included studies used a variety of criteria to define a hemorrhagic complication, which included: an isolated 2 g/dL or more decrement in hemoglobin, presence of bloody fluid on repeat tap with associated hemoglobin decrement, rapid re-accumulation of fluid with a hemoglobin decrement, or transfusion of 2 units or more of whole blood.

Whether it is safe to perform thoracentesis on patients taking antiplatelet therapy is less well understood. Although data are limited, a few small-scale studies^23,24 suggest that hemorrhagic complications following thoracentesis in patients receiving clopidogrel are comparable to the general population. We found no compelling data regarding the safety of thoracentesis in the setting of direct oral anticoagulants, heparin, low-molecular weight heparin, or intravenous direct thrombin inhibitors. Current practice is to generally avoid thoracentesis while these therapeutic anticoagulants are used.

Invasive mechanical ventilation. Pleural effusion is common in patients in the intensive care unit, including those requiring mechanical ventilation.²⁵ Thoracentesis in this population is clinically important: fluid analysis in 1 study was shown to aid the diagnosis in 45% of cases and changes in treatment in 33%.²⁶ However, clinicians may be reluctant to perform thoracentesis on patients who require mechanical ventilation, given the perception of a greater risk of pneumothorax from positive pressure ventilation.

Despite this concern, a 2011 meta-analysis including 19 studies and more than 1100 patients revealed rates of pneumothorax and hemothorax comparable to nonventilated patients.²⁵ Furthermore, a 2015 prospective study that examined thoracentesis in 1377 mechanically ventilated patients revealed no difference in complication rates as well.²⁰ Therefore, evidence suggests that performance of thoracentesis in mechanically ventilated patients is not contraindicated.

Skin Disinfection and Antisepsis Precautions

The 2010 BTS guidelines list empyema and wound infection as possible complications of thoracentesis.¹⁹ However, no data regarding incidence are provided. Additionally, an alcohol-based skin cleanser (such as 2% chlorhexidine gluconate/70% isopropyl alcohol), along with sterile gloves, field, and dressing are suggested as precautionary measures.¹⁹ In 1 single-center registry of 2489 thoracenteses performed using alcohol or iodine-based antiseptic and sterile drapes, no postprocedure infections were identified.²⁷ Of note, we did not find other studies (including case reports) that reported either incidence or rate of infectious complications such as wound infection and empyema. In an era of modern skin antiseptics that have effectively reduced complications such as catheter-related bloodstream infection,²⁸ the incidence of this event is thus likely to be low.

INTRAPROCEDURAL CONSIDERATIONS

Use of Bedside Ultrasound

Portable US has particular advantages for evaluation of pleural effusion vs other imaging modalities. Compared with computerized tomography (CT), bedside US offers similar performance but is less costly, avoids both radiation exposure and need for patient transportation, and provides results instantaneously.^29,30 Compared to chest x-ray (CXR), US is more sensitive at detecting the presence, volume, and characteristics of pleural fluid^30,31 and can be up to 100% sensitive for effusions greater than 100 mL.²⁹ Furthermore, whereas CXR typically requires 200 mL of fluid to be present for detection of an effusion, US can reliably detect as little as 20 mL of fluid.²⁹ When US was used to confirm thoracentesis puncture sites in a study involving 30 physicians of varying experience and 67 consecutive patients, 15% of sites found by clinical exam were inaccurate (less than 10 mm fluid present), 10% were at high risk for organ puncture, and a suitable fluid pocket was found 54% of times when exam could not.⁴

A 2010 meta-analysis of 24 studies and 6605 thoracenteses estimated the overall rate of pneumothorax at 6%; however, procedures performed with US guidance were associated with a 70% reduced risk of this event (odds ratio, 0.30; 95% confidence interval, 0.20 - 0.70).³² In a 2014 randomized control trial of 160 patients that compared thoracentesis with US guidance for site marking vs no US use, 10 pneumothoraces occurred in the control group vs 1 in the US group (12.5% vs 1.25%, P = 0.009).³³ Similarly, another retrospective review of 445 consecutive patients with malignant effusions revealed a pneumothorax rate of 0.97% using US in real time during needle insertion compared to 8.89% for unguided thoracenteses (P < 0.0001).³⁴ Several other studies using US guidance for either site markup or in real time reported similar pneumothorax rates, ranging from 1.1% - 4.8%.^35-37 However, it is unclear if real-time US specifically provides an additive effect vs site marking alone, as no studies directly comparing the 2 methods were found.

Benefits of US also include a higher rate of procedural success, with 1 study demonstrating a 99% success rate when using US vs. 90% without (P = 0.030).³³ A larger volume of fluid removed has been observed with US use as well, and methods have been described using fluid-pocket depth to guide puncture site localization and maximize drainage.³⁸ Finally, US use for thoracentesis has been associated with lower costs and length of stay.^39,40

Intercostal Artery Localization

Although rare (incidence, 0.18%-2%^20,21,39), the occurrence of hemothorax following thoracentesis is potentially catastrophic. This serious complication is often caused by laceration of the intercostal artery (ICA) or 1 of its branches during needle insertion.⁴¹

While risk of injury is theoretically reduced by needle insertion superior to the rib, studies using cadaver dissection and 3D angiography show significant tortuosity of the ICA.^6,41-43 The degree of tortuosity is increased within 6 cm of the midline, in more cephalad rib spaces, and in the elderly (older than 60 years).^41-43 Furthermore, 1 cadaveric study also demonstrated the presence of arterial collaterals branching off the ICA at multiple intercostal spaces, ranging between 8 cm and 11 cm from the midline.⁴¹ This anatomic variability may explain why some have observed low complication and hemothorax rates with an extreme lateral approach.³⁵ Bedside US with color flow Doppler imaging has been used to identify the ICA, with 88% sensitivity compared to CT imaging while adding little to exam time.^44,45 Of note, a 37% drop in the rate of hemothorax was observed in 1 study with routine US guidance alone.³⁹

Pleural Pressure Monitoring and Large-Volume Thoracentesis

While normal intrapleural pressures are approximately -5 to -10 cm H₂O,⁴⁶ the presence of a pleural effusion creates a complex interaction between fluid, compressed lung, and chest wall that can increase these pressures.⁴⁷ During drainage of an effusion, pleural pressures may rapidly drop, provoking re-expansion pulmonary edema (REPE). While rare (0 -1%), clinically-diagnosed REPE is a serious complication that can lead to rapid respiratory failure and death.^20,48 REPE is postulated to be caused by increased capillary permeability resulting from inflammation, driven by rapid re-inflation of the lung when exposed to highly negative intrapleural pressures.^47,49

Measurement of intrapleural pressure using a water manometer during thoracentesis may minimize REPE by terminating fluid drainage when intrapleural pressure begins to drop rapidly.^50,51 A cutoff of -20 cm H₂O has been cited repeatedly as safe since being suggested by Light in 1980, but this is based on animal models.^50,52 In 1 prospective study of 185 thoracenteses in which manometry was performed, 15% of patients had intrapleural pressure drop to less than -20 cm H₂O (at which point the procedure was terminated) but suffered no REPE.⁵⁰

Manometry is valuable in the identification of an unexpandable or trapped lung when pleural pressures drop rapidly with only minimal fluid volume removal.^47,53 Other findings correlated with an unexpandable lung include a negative opening pressure⁴⁷ and large fluctuations in pressure during the respiratory cycle.⁵⁴

While development of symptoms (eg, chest pain, cough, or dyspnea) is often used as a surrogate, the correlation between intrapleural pressure and patient symptoms is inconsistent and not a reliable proxy.⁵⁵ One study found that 22% of patients with chest pain during thoracentesis had intrapleural pressures lower than -20 cm H₂O compared with 8.6% of asymptomatic patients,⁵⁶ but it is unclear if the association is causal.

Thoracentesis is often performed for symptomatic relief and removal of large fluid volume. However, it remains common to halt fluid removal after 1.5 L, a threshold endorsed by BTS.¹⁹ While some investigators have suggested that removal of 2 L or more of pleural fluid does not compromise safety,^57,58 a 4- to 5-fold rise in the risk of pneumothorax was noted in 2 studies.^20,59 when more than 1.5 L of fluid was removed. The majority of these may be related to pneumothorax ex vacuo, a condition in which fluid is drained from the chest, but the lung is unable to expand and fill the space (eg, “trapped lung”), resulting in a persistent pneumothorax. This condition generally does not require treatment.⁶⁰ When manometry is employed at 200-mL intervals with termination at an intrapleural pressure of less than 20 mm H₂O, drainage of 3 L or more has been reported with low rates of pneumothorax and very low rates of REPE.^50,51 However, whether this is cause and effect is unknown because REPE is rare, and more work is needed to determine the role of manometry for its prevention.

POSTPROCEDURAL CONSIDERATIONS

Postprocedure Imaging

Performing an upright CXR following thoracentesis is a practice that remains routinely done by many practitioners to monitor for complications. Such imaging was also endorsed by the American Thoracic Society guidelines.⁶¹ However, more recent data question the utility of this practice. Multiple studies have confirmed that post-thoracentesis CXR is unnecessary unless clinical suspicion for pneumothorax or REPE is present.^36,58,62,63 The BTS guidelines also advocate this approach.¹⁹ Interestingly, a potentially more effective way to screen for postprocedure complications is through bedside US, which has been shown to be more sensitive than CXR in detecting pneumothorax.⁶⁴ In 1 study of 185 patients, bedside US demonstrated a sensitivity of 88% and a specificity of 97% for diagnosing pneumothorax in patients with adequate quality scans, with positive and negative likelihood ratios of 55 and 0.17, respectively.⁶⁵

Thoracentesis remains a core procedural skill for hospitalists, critical care physicians, and emergency physicians. It is the foundational component when investigating and treating pleural effusions. When the most current training, techniques, and technology are used, data suggest this procedure is safe to perform at the bedside. Our review highlights these strategies and evaluates which aspects might be most applicable to clinical practice.

Our findings have several implications for those who perform this procedure. First, appropriate training is central to procedural safety, and both simulation and direct observation by procedural experts have been shown by multiple investigators to improve knowledge and skill. This training should integrate the use of US in performing a focused thoracic exam.

Second, recommendations regarding coagulopathy and a “safe cutoff” of an INR less than 1.5 or platelets greater than 50,000/µL had limited evidentiary support. Rather, multiple studies suggest no difference in bleeding risk following thoracentesis with an INR as high as 3.0 and platelets greater than 25,000/µL. Furthermore, prophylactic transfusion with fresh frozen plasma or platelets before thoracentesis did not alter bleeding risk and exposes patients to transfusion complications. Thus, routine use of this practice can no longer be recommended. Third, further research is needed to understand the bleeding risk for patients on antiplatelet medications, heparin products, and also direct oral anticoagulants, given the growing popularity in their use and the potential consequences of even temporary cessation. Regarding patients on mechanical ventilation, thoracentesis demonstrated no difference in complication rates vs. the general population, and its performance in this population is encouraged when clinically indicated.

Intraprocedural considerations include the use of bedside US. Due to multiple benefits including effusion characterization, puncture site localization, and significantly lower rates of pneumothorax, the standard of care should be to perform thoracentesis with US guidance. Both use of US to mark an effusion immediately prior to puncture or in real time during needle insertion demonstrated benefit; however, it is unclear if 1 method is superior because no direct comparison studies were found. Further work is needed to investigate this potential.

Our review suggests that the location and course of the ICA is variable, especially near the midline, in the elderly, and in higher intercostal spaces, leaving it vulnerable to laceration. We recommend physicians only attempt thoracentesis at least 6 cm lateral to the midline due to ICA tortuosity and, ideally, 12 cm lateral, to avoid the presence of collaterals. Although only 2 small-scale studies were found pertaining to the use of US in identifying the ICA, we encourage physicians to consider learning how to screen for its presence as a part of their routine thoracic US exam in the area underlying the planned puncture site.

Manometry is beneficial because it can diagnose a nonexpandable lung and allows for pleural pressure monitoring.^52,53 A simple U-shaped manometer can be constructed from intravenous tubing included in most thoracentesis kits, which adds little to overall procedure time. While low rates of REPE have been observed when terminating thoracentesis if pressures drop below -20 cm H₂O or chest pain develops, neither measure appears to have reliable predictive value, limiting clinical utility. Further work is required to determine if a “safe pressure cutoff” exists. In general, we recommend the use of manometry when a nonexpandable (trapped) lung is suspected, because large drops in intrapleural pressure, a negative opening pressure, and respiratory variation can help confirm the diagnosis and avoid pneumothorax ex vacuo or unnecessary procedures in the future. As this condition appears to be more common in the setting of larger effusions, use of manometry when large-volume thoracenteses are planned is also reasonable.

Postprocedurally, routine imaging after thoracentesis is not recommended unless there is objective concern for complication. When indicated, bedside US is better positioned for this role compared with CXR, because it is more sensitive in detecting pneumothorax, provides instantaneous results, and avoids radiation exposure.

Our review has limitations. First, we searched only for articles between defined time periods, restricted our search to a single database, and excluded non-English articles. This has the potential to introduce selection bias, as nonprimary articles that fall within our time restrictions may cite older studies that are outside our search range. To minimize this effect, we performed a critical review of all included studies, especially nonprimary articles. Second, despite the focus of our search strategy to identify any articles related to patient safety and adverse events, we cannot guarantee that all relevant articles for any particular complication or risk factor were captured given the lack of more specific search terms. Third, although we performed a systematic search of the literature, we did not perform a formal systematic review or formally grade included studies. As the goal of our review was to categorize and operationalize clinical aspects, this approach was necessary, and we acknowledge that the quality of studies is variable. Lastly, we aimed to generate clinical recommendations for physicians performing thoracentesis at the bedside; others reviewing this literature may find or emphasize different aspects relevant to practice outside this setting.

In conclusion, evaluation and treatment of pleural effusions with bedside thoracentesis is an important skill for physicians of many disciplines. The evidence presented in this review will help inform the process and ensure patient safety. Physicians should consider incorporating these recommendations into their practice.

Acknowledgments

The authors thank Whitney Townsend, MLIS, health sciences informationist, for assistance with serial literature searches.

Disclosure

Nothing to report.

Pleural effusion can occur in myriad conditions including infection, heart failure, liver disease, and cancer.¹ Consequently, physicians from many disciplines routinely encounter both inpatients and outpatients with this diagnosis. Often, evaluation and treatment require thoracentesis to obtain fluid for analysis or symptom relief.

Although historically performed at the bedside without imaging guidance or intraprocedural monitoring, thoracentesis performed in this fashion carries considerable risk of complications. In fact, it has 1 of the highest rates of iatrogenic pneumothorax among bedside procedures.² However, recent advances in practice and adoption of newer technologies have helped to mitigate risks associated with this procedure. These advances are relevant because approximately 50% of thoracenteses are still performed at the bedside.³ In this review, we aim to identify the most recent key practices that enhance the safety and the effectiveness of thoracentesis for practicing clinicians.

Information Sources and Search Strategy

With the assistance of a research librarian, we performed a systematic search of PubMed-indexed articles from January 1, 2000 to September 30, 2015. Articles were identified using search terms such as thoracentesis, pleural effusion, safety, medical error, adverse event, and ultrasound in combination with Boolean operators. Of note, as thoracentesis is indexed as a subgroup of paracentesis in PubMed, this term was also included to increase the sensitivity of the search. The full search strategy is available in the Appendix. Any references cited in this review outside of the date range of our search are provided only to give relevant background information or establish the origin of commonly performed practices.

Study Eligibility and Selection Criteria

Studies were included if they reported clinical aspects related to thoracentesis. We defined clinical aspects as those strategies that focused on operator training, procedural techniques, technology, management, or prevention of complications. Non-English language articles, animal studies, case reports, conference proceedings, and abstracts were excluded. As our intention was to focus on the contemporary advances related to thoracentesis performance, (eg, ultrasound [US]), our search was limited to studies published after the year 2000. Two authors, Drs. Schildhouse and Lai independently screened studies to determine inclusion, excluding studies with weak methodology, very small sample sizes, and those only tangentially related to our aim. Disagreements regarding study inclusion were resolved by consensus. Drs. Lai, Barsuk, and Mourad identified additional studies by hand review of reference lists and content experts (Figure 1).

Conceptual Framework

All selected articles were categorized by temporal relationship to thoracentesis as pre-, intra-, or postprocedure. Pre-procedural topics were those outcomes that had been identified and addressed before attempting thoracentesis, such as physician training or perceived risks of harm. Intraprocedural considerations included aspects such as use of bedside US, pleural manometry, and large-volume drainage. Finally, postprocedural factors were those related to evaluation after thoracentesis, such as follow-up imaging. This conceptual framework is outlined in Figure 2.

The PubMed search returned a total of 1170 manuscripts, of which 56 articles met inclusion criteria. Four additional articles were identified by experts and included in the study.^4-7 Therefore, 60 articles were identified and included in this review. Study designs included cohort studies, case control studies, systematic reviews, meta-analyses, narrative reviews, consensus guidelines, and randomized controlled trials. A summary of all included articles by topic can be found in the Table.
 

PRE-PROCEDURAL CONSIDERATIONS

Physician Training

Studies indicate that graduate medical education may not adequately prepare clinicians to perform thoracentesis.⁸ In fact, residents have the least exposure and confidence in performing thoracentesis when compared to other bedside procedures.^9,10 In 1 survey, 69% of medical trainees desired more exposure to procedures, and 98% felt that procedural skills were important to master.¹¹ Not surprisingly, then, graduating internal medicine residents perform poorly when assessed on a thoracentesis simulator.¹²

Supplemental training outside of residency is useful to develop and maintain skills for thoracentesis, such as simulation with direct observation in a zero-risk environment. In 1 study, “simulation-based mastery learning” combined an educational video presentation with repeated, deliberate practice on a simulator until procedural competence was acquired, over two 2-hour sessions. In this study, 40 third-year medicine residents demonstrated a 71% improvement in clinical skills performance after course completion, with 93% achieving a passing score. The remaining 7% also achieved passing scores with extra practice time.¹² Others have built upon the concept of simulation-based training. For instance, 2 studies suggest that use of a simulation-based curriculum improved both thoracentesis knowledge and performance skills in a 3-hour session.^13,14 Similarly, 1 prospective study reported that a half-day thoracentesis workshop using simulation and 1:1 direct observation successfully lowered pneumothorax rates from 8.6% to 1.8% in a group of practicing clinicians. Notably, additional interventions including use of bedside US, limiting operators to a focused group, and standardization of equipment were also a part of this quality improvement initiative.⁷ Although repetition is required to gain proficiency when using a simulator, performance and confidence appear to plateau with only 4 simulator trials. In medical students, improvements derived through simulator-based teaching were sustained when retested 6 months following training.¹⁵

An instrument to ensure competency is necessary, given variability in procedural experience among both new graduates and practicing physicians,. Our search did not identify any clinically validated tools that adequately assessed thoracentesis performance. However, some have been proposed¹⁶ and 1 validated in a simulation environment.¹² Regarding the incorporation of US for effusion markup, 1 validated tool used an 11-domain assessment covering knowledge of US machine manipulation, recognition of images with common pleural effusion characteristics, and performance of thoracic US with puncture-site marking on a simulator. When used on 22 participants, scores with the tool could reliably differentiate between novice, intermediate, and advanced groups (P < 0.0001).¹⁷

Patient Selection

Coagulopathies and Anticoagulation. Historically, the accepted cutoff for performing thoracentesis is an international normalized ratio (INR) less than 1.5 and a platelet count greater than 50,000/µL. McVay et al.¹⁸ first showed in 1991 that use of these cutoffs was associated with low rates of periprocedural bleeding, leading to endorsement in the British Thoracic Society (BTS) Pleural Disease Guideline 2010.¹⁹ Other recommendations include the 2012 Society for Interventional Radiology guidelines that endorse correction of an INR greater than 2, or platelets less than 50,000/µL, based almost exclusively on expert opinion.⁵

However, data suggest that thoracentesis may be safely performed outside these parameters. For instance, a prospective study of approximately 9000 thoracenteses over 12 years found that patients with an INR of 1.5-2.9 or platelets of 20,000 - 49,000/µL experienced rates of bleeding complications similar to those with normal values.²⁰ Similarly, a 2014 review²¹ found that the overall risk of hemorrhage during thoracentesis in the setting of moderate coagulopathy (defined as an INR of 1.5 - 3 or platelets of 25,000-50,000/µL), was not increased. In 1 retrospective study of more than 1000 procedures, no differences in hemorrhagic events were noted in patients with bleeding diatheses that received prophylactic fresh frozen plasma or platelets vs. those who did not.²² Of note, included studies used a variety of criteria to define a hemorrhagic complication, which included: an isolated 2 g/dL or more decrement in hemoglobin, presence of bloody fluid on repeat tap with associated hemoglobin decrement, rapid re-accumulation of fluid with a hemoglobin decrement, or transfusion of 2 units or more of whole blood.

Whether it is safe to perform thoracentesis on patients taking antiplatelet therapy is less well understood. Although data are limited, a few small-scale studies^23,24 suggest that hemorrhagic complications following thoracentesis in patients receiving clopidogrel are comparable to the general population. We found no compelling data regarding the safety of thoracentesis in the setting of direct oral anticoagulants, heparin, low-molecular weight heparin, or intravenous direct thrombin inhibitors. Current practice is to generally avoid thoracentesis while these therapeutic anticoagulants are used.

Invasive mechanical ventilation. Pleural effusion is common in patients in the intensive care unit, including those requiring mechanical ventilation.²⁵ Thoracentesis in this population is clinically important: fluid analysis in 1 study was shown to aid the diagnosis in 45% of cases and changes in treatment in 33%.²⁶ However, clinicians may be reluctant to perform thoracentesis on patients who require mechanical ventilation, given the perception of a greater risk of pneumothorax from positive pressure ventilation.

Despite this concern, a 2011 meta-analysis including 19 studies and more than 1100 patients revealed rates of pneumothorax and hemothorax comparable to nonventilated patients.²⁵ Furthermore, a 2015 prospective study that examined thoracentesis in 1377 mechanically ventilated patients revealed no difference in complication rates as well.²⁰ Therefore, evidence suggests that performance of thoracentesis in mechanically ventilated patients is not contraindicated.

Skin Disinfection and Antisepsis Precautions

The 2010 BTS guidelines list empyema and wound infection as possible complications of thoracentesis.¹⁹ However, no data regarding incidence are provided. Additionally, an alcohol-based skin cleanser (such as 2% chlorhexidine gluconate/70% isopropyl alcohol), along with sterile gloves, field, and dressing are suggested as precautionary measures.¹⁹ In 1 single-center registry of 2489 thoracenteses performed using alcohol or iodine-based antiseptic and sterile drapes, no postprocedure infections were identified.²⁷ Of note, we did not find other studies (including case reports) that reported either incidence or rate of infectious complications such as wound infection and empyema. In an era of modern skin antiseptics that have effectively reduced complications such as catheter-related bloodstream infection,²⁸ the incidence of this event is thus likely to be low.

INTRAPROCEDURAL CONSIDERATIONS

Use of Bedside Ultrasound

Portable US has particular advantages for evaluation of pleural effusion vs other imaging modalities. Compared with computerized tomography (CT), bedside US offers similar performance but is less costly, avoids both radiation exposure and need for patient transportation, and provides results instantaneously.^29,30 Compared to chest x-ray (CXR), US is more sensitive at detecting the presence, volume, and characteristics of pleural fluid^30,31 and can be up to 100% sensitive for effusions greater than 100 mL.²⁹ Furthermore, whereas CXR typically requires 200 mL of fluid to be present for detection of an effusion, US can reliably detect as little as 20 mL of fluid.²⁹ When US was used to confirm thoracentesis puncture sites in a study involving 30 physicians of varying experience and 67 consecutive patients, 15% of sites found by clinical exam were inaccurate (less than 10 mm fluid present), 10% were at high risk for organ puncture, and a suitable fluid pocket was found 54% of times when exam could not.⁴

A 2010 meta-analysis of 24 studies and 6605 thoracenteses estimated the overall rate of pneumothorax at 6%; however, procedures performed with US guidance were associated with a 70% reduced risk of this event (odds ratio, 0.30; 95% confidence interval, 0.20 - 0.70).³² In a 2014 randomized control trial of 160 patients that compared thoracentesis with US guidance for site marking vs no US use, 10 pneumothoraces occurred in the control group vs 1 in the US group (12.5% vs 1.25%, P = 0.009).³³ Similarly, another retrospective review of 445 consecutive patients with malignant effusions revealed a pneumothorax rate of 0.97% using US in real time during needle insertion compared to 8.89% for unguided thoracenteses (P < 0.0001).³⁴ Several other studies using US guidance for either site markup or in real time reported similar pneumothorax rates, ranging from 1.1% - 4.8%.^35-37 However, it is unclear if real-time US specifically provides an additive effect vs site marking alone, as no studies directly comparing the 2 methods were found.

Benefits of US also include a higher rate of procedural success, with 1 study demonstrating a 99% success rate when using US vs. 90% without (P = 0.030).³³ A larger volume of fluid removed has been observed with US use as well, and methods have been described using fluid-pocket depth to guide puncture site localization and maximize drainage.³⁸ Finally, US use for thoracentesis has been associated with lower costs and length of stay.^39,40

Intercostal Artery Localization

Although rare (incidence, 0.18%-2%^20,21,39), the occurrence of hemothorax following thoracentesis is potentially catastrophic. This serious complication is often caused by laceration of the intercostal artery (ICA) or 1 of its branches during needle insertion.⁴¹

While risk of injury is theoretically reduced by needle insertion superior to the rib, studies using cadaver dissection and 3D angiography show significant tortuosity of the ICA.^6,41-43 The degree of tortuosity is increased within 6 cm of the midline, in more cephalad rib spaces, and in the elderly (older than 60 years).^41-43 Furthermore, 1 cadaveric study also demonstrated the presence of arterial collaterals branching off the ICA at multiple intercostal spaces, ranging between 8 cm and 11 cm from the midline.⁴¹ This anatomic variability may explain why some have observed low complication and hemothorax rates with an extreme lateral approach.³⁵ Bedside US with color flow Doppler imaging has been used to identify the ICA, with 88% sensitivity compared to CT imaging while adding little to exam time.^44,45 Of note, a 37% drop in the rate of hemothorax was observed in 1 study with routine US guidance alone.³⁹

Pleural Pressure Monitoring and Large-Volume Thoracentesis

While normal intrapleural pressures are approximately -5 to -10 cm H₂O,⁴⁶ the presence of a pleural effusion creates a complex interaction between fluid, compressed lung, and chest wall that can increase these pressures.⁴⁷ During drainage of an effusion, pleural pressures may rapidly drop, provoking re-expansion pulmonary edema (REPE). While rare (0 -1%), clinically-diagnosed REPE is a serious complication that can lead to rapid respiratory failure and death.^20,48 REPE is postulated to be caused by increased capillary permeability resulting from inflammation, driven by rapid re-inflation of the lung when exposed to highly negative intrapleural pressures.^47,49

Measurement of intrapleural pressure using a water manometer during thoracentesis may minimize REPE by terminating fluid drainage when intrapleural pressure begins to drop rapidly.^50,51 A cutoff of -20 cm H₂O has been cited repeatedly as safe since being suggested by Light in 1980, but this is based on animal models.^50,52 In 1 prospective study of 185 thoracenteses in which manometry was performed, 15% of patients had intrapleural pressure drop to less than -20 cm H₂O (at which point the procedure was terminated) but suffered no REPE.⁵⁰

Manometry is valuable in the identification of an unexpandable or trapped lung when pleural pressures drop rapidly with only minimal fluid volume removal.^47,53 Other findings correlated with an unexpandable lung include a negative opening pressure⁴⁷ and large fluctuations in pressure during the respiratory cycle.⁵⁴

While development of symptoms (eg, chest pain, cough, or dyspnea) is often used as a surrogate, the correlation between intrapleural pressure and patient symptoms is inconsistent and not a reliable proxy.⁵⁵ One study found that 22% of patients with chest pain during thoracentesis had intrapleural pressures lower than -20 cm H₂O compared with 8.6% of asymptomatic patients,⁵⁶ but it is unclear if the association is causal.

Thoracentesis is often performed for symptomatic relief and removal of large fluid volume. However, it remains common to halt fluid removal after 1.5 L, a threshold endorsed by BTS.¹⁹ While some investigators have suggested that removal of 2 L or more of pleural fluid does not compromise safety,^57,58 a 4- to 5-fold rise in the risk of pneumothorax was noted in 2 studies.^20,59 when more than 1.5 L of fluid was removed. The majority of these may be related to pneumothorax ex vacuo, a condition in which fluid is drained from the chest, but the lung is unable to expand and fill the space (eg, “trapped lung”), resulting in a persistent pneumothorax. This condition generally does not require treatment.⁶⁰ When manometry is employed at 200-mL intervals with termination at an intrapleural pressure of less than 20 mm H₂O, drainage of 3 L or more has been reported with low rates of pneumothorax and very low rates of REPE.^50,51 However, whether this is cause and effect is unknown because REPE is rare, and more work is needed to determine the role of manometry for its prevention.

POSTPROCEDURAL CONSIDERATIONS

Postprocedure Imaging

Performing an upright CXR following thoracentesis is a practice that remains routinely done by many practitioners to monitor for complications. Such imaging was also endorsed by the American Thoracic Society guidelines.⁶¹ However, more recent data question the utility of this practice. Multiple studies have confirmed that post-thoracentesis CXR is unnecessary unless clinical suspicion for pneumothorax or REPE is present.^36,58,62,63 The BTS guidelines also advocate this approach.¹⁹ Interestingly, a potentially more effective way to screen for postprocedure complications is through bedside US, which has been shown to be more sensitive than CXR in detecting pneumothorax.⁶⁴ In 1 study of 185 patients, bedside US demonstrated a sensitivity of 88% and a specificity of 97% for diagnosing pneumothorax in patients with adequate quality scans, with positive and negative likelihood ratios of 55 and 0.17, respectively.⁶⁵

Thoracentesis remains a core procedural skill for hospitalists, critical care physicians, and emergency physicians. It is the foundational component when investigating and treating pleural effusions. When the most current training, techniques, and technology are used, data suggest this procedure is safe to perform at the bedside. Our review highlights these strategies and evaluates which aspects might be most applicable to clinical practice.

Our findings have several implications for those who perform this procedure. First, appropriate training is central to procedural safety, and both simulation and direct observation by procedural experts have been shown by multiple investigators to improve knowledge and skill. This training should integrate the use of US in performing a focused thoracic exam.

Second, recommendations regarding coagulopathy and a “safe cutoff” of an INR less than 1.5 or platelets greater than 50,000/µL had limited evidentiary support. Rather, multiple studies suggest no difference in bleeding risk following thoracentesis with an INR as high as 3.0 and platelets greater than 25,000/µL. Furthermore, prophylactic transfusion with fresh frozen plasma or platelets before thoracentesis did not alter bleeding risk and exposes patients to transfusion complications. Thus, routine use of this practice can no longer be recommended. Third, further research is needed to understand the bleeding risk for patients on antiplatelet medications, heparin products, and also direct oral anticoagulants, given the growing popularity in their use and the potential consequences of even temporary cessation. Regarding patients on mechanical ventilation, thoracentesis demonstrated no difference in complication rates vs. the general population, and its performance in this population is encouraged when clinically indicated.

Intraprocedural considerations include the use of bedside US. Due to multiple benefits including effusion characterization, puncture site localization, and significantly lower rates of pneumothorax, the standard of care should be to perform thoracentesis with US guidance. Both use of US to mark an effusion immediately prior to puncture or in real time during needle insertion demonstrated benefit; however, it is unclear if 1 method is superior because no direct comparison studies were found. Further work is needed to investigate this potential.

Our review suggests that the location and course of the ICA is variable, especially near the midline, in the elderly, and in higher intercostal spaces, leaving it vulnerable to laceration. We recommend physicians only attempt thoracentesis at least 6 cm lateral to the midline due to ICA tortuosity and, ideally, 12 cm lateral, to avoid the presence of collaterals. Although only 2 small-scale studies were found pertaining to the use of US in identifying the ICA, we encourage physicians to consider learning how to screen for its presence as a part of their routine thoracic US exam in the area underlying the planned puncture site.

Manometry is beneficial because it can diagnose a nonexpandable lung and allows for pleural pressure monitoring.^52,53 A simple U-shaped manometer can be constructed from intravenous tubing included in most thoracentesis kits, which adds little to overall procedure time. While low rates of REPE have been observed when terminating thoracentesis if pressures drop below -20 cm H₂O or chest pain develops, neither measure appears to have reliable predictive value, limiting clinical utility. Further work is required to determine if a “safe pressure cutoff” exists. In general, we recommend the use of manometry when a nonexpandable (trapped) lung is suspected, because large drops in intrapleural pressure, a negative opening pressure, and respiratory variation can help confirm the diagnosis and avoid pneumothorax ex vacuo or unnecessary procedures in the future. As this condition appears to be more common in the setting of larger effusions, use of manometry when large-volume thoracenteses are planned is also reasonable.

Postprocedurally, routine imaging after thoracentesis is not recommended unless there is objective concern for complication. When indicated, bedside US is better positioned for this role compared with CXR, because it is more sensitive in detecting pneumothorax, provides instantaneous results, and avoids radiation exposure.

Our review has limitations. First, we searched only for articles between defined time periods, restricted our search to a single database, and excluded non-English articles. This has the potential to introduce selection bias, as nonprimary articles that fall within our time restrictions may cite older studies that are outside our search range. To minimize this effect, we performed a critical review of all included studies, especially nonprimary articles. Second, despite the focus of our search strategy to identify any articles related to patient safety and adverse events, we cannot guarantee that all relevant articles for any particular complication or risk factor were captured given the lack of more specific search terms. Third, although we performed a systematic search of the literature, we did not perform a formal systematic review or formally grade included studies. As the goal of our review was to categorize and operationalize clinical aspects, this approach was necessary, and we acknowledge that the quality of studies is variable. Lastly, we aimed to generate clinical recommendations for physicians performing thoracentesis at the bedside; others reviewing this literature may find or emphasize different aspects relevant to practice outside this setting.

In conclusion, evaluation and treatment of pleural effusions with bedside thoracentesis is an important skill for physicians of many disciplines. The evidence presented in this review will help inform the process and ensure patient safety. Physicians should consider incorporating these recommendations into their practice.

Acknowledgments

The authors thank Whitney Townsend, MLIS, health sciences informationist, for assistance with serial literature searches.

Disclosure

Nothing to report.