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Computer-Based Reminders Have Small to Modest Effect on Care Processes
Clinical question: Do on-screen, computer-based clinical reminders improve adherence to target processes of care or clinical outcomes?
Background: Gaps between practice guidelines and routine care are caused, in part, by the inability of clinicians to access or recall information at the point of care. Although automated reminder systems offer the promise of “just in time” recommendations, studies of electronic reminders have demonstrated mixed results.
Study design: Literature review and meta-analysis.
Setting: Multiple databases and information repositories, including MEDLINE, EMBASE, and CINAHL.
Synopsis: The authors conducted a literature search to identify randomized and quasi-randomized controlled trials measuring the effect of computer-based reminders on process measures or clinical outcomes. To avoid statistical challenges inherent in unit-of-analysis errors, the authors reported median improvement in process adherence or median change in clinical endpoints.
Out of a pool of 2,036 citations, 28 studies detailing 32 comparative analyses were included. Across the 28 studies, reminders resulted in a median improvement in target process adherence of 4.2% (3.3% for prescribing behavior, 2.8% for test ordering). Eight comparisons reported dichotomous clinical endpoints and collectively showed a median absolute improvement of 2.5%.
The greatest contribution to measured treatment effects came from large academic centers with well-established electronic health records and robust informatics departments. No characteristics of the reminder system or the clinical context were associated with the magnitude of impact. A potential limitation in reporting median effects across studies is that all studies were given equal weight.
Bottom line: Electronic reminders appear to have a small, positive effect on clinician adherence to recommended processes, although it is uncertain what contextual or design features are responsible for the greatest treatment effect.
Citation: Shojania K, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009(3):CD001096. TH
Clinical question: Do on-screen, computer-based clinical reminders improve adherence to target processes of care or clinical outcomes?
Background: Gaps between practice guidelines and routine care are caused, in part, by the inability of clinicians to access or recall information at the point of care. Although automated reminder systems offer the promise of “just in time” recommendations, studies of electronic reminders have demonstrated mixed results.
Study design: Literature review and meta-analysis.
Setting: Multiple databases and information repositories, including MEDLINE, EMBASE, and CINAHL.
Synopsis: The authors conducted a literature search to identify randomized and quasi-randomized controlled trials measuring the effect of computer-based reminders on process measures or clinical outcomes. To avoid statistical challenges inherent in unit-of-analysis errors, the authors reported median improvement in process adherence or median change in clinical endpoints.
Out of a pool of 2,036 citations, 28 studies detailing 32 comparative analyses were included. Across the 28 studies, reminders resulted in a median improvement in target process adherence of 4.2% (3.3% for prescribing behavior, 2.8% for test ordering). Eight comparisons reported dichotomous clinical endpoints and collectively showed a median absolute improvement of 2.5%.
The greatest contribution to measured treatment effects came from large academic centers with well-established electronic health records and robust informatics departments. No characteristics of the reminder system or the clinical context were associated with the magnitude of impact. A potential limitation in reporting median effects across studies is that all studies were given equal weight.
Bottom line: Electronic reminders appear to have a small, positive effect on clinician adherence to recommended processes, although it is uncertain what contextual or design features are responsible for the greatest treatment effect.
Citation: Shojania K, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009(3):CD001096. TH
Clinical question: Do on-screen, computer-based clinical reminders improve adherence to target processes of care or clinical outcomes?
Background: Gaps between practice guidelines and routine care are caused, in part, by the inability of clinicians to access or recall information at the point of care. Although automated reminder systems offer the promise of “just in time” recommendations, studies of electronic reminders have demonstrated mixed results.
Study design: Literature review and meta-analysis.
Setting: Multiple databases and information repositories, including MEDLINE, EMBASE, and CINAHL.
Synopsis: The authors conducted a literature search to identify randomized and quasi-randomized controlled trials measuring the effect of computer-based reminders on process measures or clinical outcomes. To avoid statistical challenges inherent in unit-of-analysis errors, the authors reported median improvement in process adherence or median change in clinical endpoints.
Out of a pool of 2,036 citations, 28 studies detailing 32 comparative analyses were included. Across the 28 studies, reminders resulted in a median improvement in target process adherence of 4.2% (3.3% for prescribing behavior, 2.8% for test ordering). Eight comparisons reported dichotomous clinical endpoints and collectively showed a median absolute improvement of 2.5%.
The greatest contribution to measured treatment effects came from large academic centers with well-established electronic health records and robust informatics departments. No characteristics of the reminder system or the clinical context were associated with the magnitude of impact. A potential limitation in reporting median effects across studies is that all studies were given equal weight.
Bottom line: Electronic reminders appear to have a small, positive effect on clinician adherence to recommended processes, although it is uncertain what contextual or design features are responsible for the greatest treatment effect.
Citation: Shojania K, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009(3):CD001096. TH
Patient Participation in Medication Reconciliation at Discharge Helps Detect Prescribing Discrepancies
Clinical question: Does the inclusion of a medication adherence counseling session during a hospital discharge reconciliation process reduce discrepancies in the final medication regimen?
Background: Inadvertent medication prescribing errors are an important cause of preventable adverse drug events and commonly occur at transitions of care. Although medication reconciliation processes can identify errors, the best strategies for implementation remain unclear.
Study design: Prospective, observational cohort.
Setting: A 550-bed teaching hospital in the Netherlands.
Synopsis: Of 437 patients admitted to a pulmonary ward and screened for eligibility, 267 were included in the analysis. A pharmacy specialist reviewed all available community prescription records, inpatient documentation, and discharge medication lists in an effort to identify discrepancies. Potential errors were discussed with the prescriber. Then, the pharmacy specialist interviewed the patient and provided additional counseling. Any new discrepancies were discussed with the prescriber. All questions raised by the pharmacist were recorded, as were all subsequent prescriber interventions.
The primary outcome measure was the number of interventions made as a result of pharmacy review. A total of 940 questions were asked. At least one intervention was recorded for 87% of patients before counseling (mean 2.7 interventions/patient) and for 97% of patients after (mean 5.3 interventions/patient). Discrepancies were addressed for 63.7% of patients before counseling and 72.5% after. Pharmacotherapy was optimized for 67.2% of patients before counseling and 76.3% after.
Bottom line: Patient engagement in the medication reconciliation process incrementally improves the quality of the history and helps identify clinically meaningful discrepancies at the time of hospital discharge.
Citation: Karapinar-Carkit F, Borgsteede S, Zoer J, Smit HJ, Egberts AC, van den Bemt P. Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009;43(6):1001-1010.
Clinical question: Does the inclusion of a medication adherence counseling session during a hospital discharge reconciliation process reduce discrepancies in the final medication regimen?
Background: Inadvertent medication prescribing errors are an important cause of preventable adverse drug events and commonly occur at transitions of care. Although medication reconciliation processes can identify errors, the best strategies for implementation remain unclear.
Study design: Prospective, observational cohort.
Setting: A 550-bed teaching hospital in the Netherlands.
Synopsis: Of 437 patients admitted to a pulmonary ward and screened for eligibility, 267 were included in the analysis. A pharmacy specialist reviewed all available community prescription records, inpatient documentation, and discharge medication lists in an effort to identify discrepancies. Potential errors were discussed with the prescriber. Then, the pharmacy specialist interviewed the patient and provided additional counseling. Any new discrepancies were discussed with the prescriber. All questions raised by the pharmacist were recorded, as were all subsequent prescriber interventions.
The primary outcome measure was the number of interventions made as a result of pharmacy review. A total of 940 questions were asked. At least one intervention was recorded for 87% of patients before counseling (mean 2.7 interventions/patient) and for 97% of patients after (mean 5.3 interventions/patient). Discrepancies were addressed for 63.7% of patients before counseling and 72.5% after. Pharmacotherapy was optimized for 67.2% of patients before counseling and 76.3% after.
Bottom line: Patient engagement in the medication reconciliation process incrementally improves the quality of the history and helps identify clinically meaningful discrepancies at the time of hospital discharge.
Citation: Karapinar-Carkit F, Borgsteede S, Zoer J, Smit HJ, Egberts AC, van den Bemt P. Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009;43(6):1001-1010.
Clinical question: Does the inclusion of a medication adherence counseling session during a hospital discharge reconciliation process reduce discrepancies in the final medication regimen?
Background: Inadvertent medication prescribing errors are an important cause of preventable adverse drug events and commonly occur at transitions of care. Although medication reconciliation processes can identify errors, the best strategies for implementation remain unclear.
Study design: Prospective, observational cohort.
Setting: A 550-bed teaching hospital in the Netherlands.
Synopsis: Of 437 patients admitted to a pulmonary ward and screened for eligibility, 267 were included in the analysis. A pharmacy specialist reviewed all available community prescription records, inpatient documentation, and discharge medication lists in an effort to identify discrepancies. Potential errors were discussed with the prescriber. Then, the pharmacy specialist interviewed the patient and provided additional counseling. Any new discrepancies were discussed with the prescriber. All questions raised by the pharmacist were recorded, as were all subsequent prescriber interventions.
The primary outcome measure was the number of interventions made as a result of pharmacy review. A total of 940 questions were asked. At least one intervention was recorded for 87% of patients before counseling (mean 2.7 interventions/patient) and for 97% of patients after (mean 5.3 interventions/patient). Discrepancies were addressed for 63.7% of patients before counseling and 72.5% after. Pharmacotherapy was optimized for 67.2% of patients before counseling and 76.3% after.
Bottom line: Patient engagement in the medication reconciliation process incrementally improves the quality of the history and helps identify clinically meaningful discrepancies at the time of hospital discharge.
Citation: Karapinar-Carkit F, Borgsteede S, Zoer J, Smit HJ, Egberts AC, van den Bemt P. Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009;43(6):1001-1010.
Negative D-Dimer Test Can Safely Exclude Pulmonary Embolism in Patients at Low To Intermediate Clinical Risk
Clinical question: In patients with symptoms consistent with pulmonary embolism (PE), can evaluation with a clinical risk assessment tool and D-dimer assay identify patients who do not require CT angiography to exclude PE?
Background: D-dimer is a highly sensitive but nonspecific marker of VTE, and studies suggest that VTE can be ruled out without further imaging in patients with low clinical probability of disease and a negative D-dimer test. Nevertheless, this practice has not been adopted uniformly, and CT angiography (CTA) overuse continues.
Study design: Prospective registry cohort.
Setting: A 550-bed community teaching hospital in Chicago.
Synopsis: Consecutive patients presenting to the ED with symptoms suggestive of PE were evaluated with 1) revised Geneva score; 2) D-dimer assay; and 3) CTA. Among the 627 patients who underwent all three components of the evaluation, 44.8% were identified as low probability for PE by revised Geneva score, 52.6% as intermediate probability, and 2.6% as high probability. The overall prevalence of PE (using CTA as the gold standard) was very low (4.5%); just 2.1% of low-risk, 5.2% of intermediate-risk, and 31.2% of high-risk patients were ultimately found to have PE on CTA.
Using a cutoff of 1.2 mg/L, the D-dimer assay accurately detected all low- to intermediate-probability patients with PE (sensitivity and negative predictive value of 100%). One patient in the high probability group did have a PE, even though the patient had a D-dimer value <1.2 mg/L (sensitivity and NPV both 80%). Had diagnostic testing stopped after a negative D-dimer result in the low- to intermediate-probability patients, 172 CTAs (27%) would have been avoided.
Bottom line: In a low-prevalence cohort, no pulmonary emboli were identified by CTA in any patient with a low to intermediate clinical risk assessment and a negative quantitative D-dimer assay result.
Citation: Gupta RT, Kakarla RK, Kirshenbaum KJ, Tapson VF. D-dimers and efficacy of clinical risk estimation algorithms: sensitivity in evaluation of acute pulmonary embolism. AJR Am J Roentgenol. 2009;193(2):425-430.
Clinical question: In patients with symptoms consistent with pulmonary embolism (PE), can evaluation with a clinical risk assessment tool and D-dimer assay identify patients who do not require CT angiography to exclude PE?
Background: D-dimer is a highly sensitive but nonspecific marker of VTE, and studies suggest that VTE can be ruled out without further imaging in patients with low clinical probability of disease and a negative D-dimer test. Nevertheless, this practice has not been adopted uniformly, and CT angiography (CTA) overuse continues.
Study design: Prospective registry cohort.
Setting: A 550-bed community teaching hospital in Chicago.
Synopsis: Consecutive patients presenting to the ED with symptoms suggestive of PE were evaluated with 1) revised Geneva score; 2) D-dimer assay; and 3) CTA. Among the 627 patients who underwent all three components of the evaluation, 44.8% were identified as low probability for PE by revised Geneva score, 52.6% as intermediate probability, and 2.6% as high probability. The overall prevalence of PE (using CTA as the gold standard) was very low (4.5%); just 2.1% of low-risk, 5.2% of intermediate-risk, and 31.2% of high-risk patients were ultimately found to have PE on CTA.
Using a cutoff of 1.2 mg/L, the D-dimer assay accurately detected all low- to intermediate-probability patients with PE (sensitivity and negative predictive value of 100%). One patient in the high probability group did have a PE, even though the patient had a D-dimer value <1.2 mg/L (sensitivity and NPV both 80%). Had diagnostic testing stopped after a negative D-dimer result in the low- to intermediate-probability patients, 172 CTAs (27%) would have been avoided.
Bottom line: In a low-prevalence cohort, no pulmonary emboli were identified by CTA in any patient with a low to intermediate clinical risk assessment and a negative quantitative D-dimer assay result.
Citation: Gupta RT, Kakarla RK, Kirshenbaum KJ, Tapson VF. D-dimers and efficacy of clinical risk estimation algorithms: sensitivity in evaluation of acute pulmonary embolism. AJR Am J Roentgenol. 2009;193(2):425-430.
Clinical question: In patients with symptoms consistent with pulmonary embolism (PE), can evaluation with a clinical risk assessment tool and D-dimer assay identify patients who do not require CT angiography to exclude PE?
Background: D-dimer is a highly sensitive but nonspecific marker of VTE, and studies suggest that VTE can be ruled out without further imaging in patients with low clinical probability of disease and a negative D-dimer test. Nevertheless, this practice has not been adopted uniformly, and CT angiography (CTA) overuse continues.
Study design: Prospective registry cohort.
Setting: A 550-bed community teaching hospital in Chicago.
Synopsis: Consecutive patients presenting to the ED with symptoms suggestive of PE were evaluated with 1) revised Geneva score; 2) D-dimer assay; and 3) CTA. Among the 627 patients who underwent all three components of the evaluation, 44.8% were identified as low probability for PE by revised Geneva score, 52.6% as intermediate probability, and 2.6% as high probability. The overall prevalence of PE (using CTA as the gold standard) was very low (4.5%); just 2.1% of low-risk, 5.2% of intermediate-risk, and 31.2% of high-risk patients were ultimately found to have PE on CTA.
Using a cutoff of 1.2 mg/L, the D-dimer assay accurately detected all low- to intermediate-probability patients with PE (sensitivity and negative predictive value of 100%). One patient in the high probability group did have a PE, even though the patient had a D-dimer value <1.2 mg/L (sensitivity and NPV both 80%). Had diagnostic testing stopped after a negative D-dimer result in the low- to intermediate-probability patients, 172 CTAs (27%) would have been avoided.
Bottom line: In a low-prevalence cohort, no pulmonary emboli were identified by CTA in any patient with a low to intermediate clinical risk assessment and a negative quantitative D-dimer assay result.
Citation: Gupta RT, Kakarla RK, Kirshenbaum KJ, Tapson VF. D-dimers and efficacy of clinical risk estimation algorithms: sensitivity in evaluation of acute pulmonary embolism. AJR Am J Roentgenol. 2009;193(2):425-430.
Patient Signout Is Not Uniformly Comprehensive and Often Lacks Critical Information
Clinical question: Do signouts vary in the quality and quantity of information, and what are the various factors affecting signout quality?
Background: Miscommunication during transfers of responsibility for hospitalized patients is common and can result in harm. Recommendations for safe and effective handoffs emphasize key content, clear communication, senior staff supervision, and adequate time for questions. Still, little is known about adherence to these recommendations in clinical practice.
Study design: Prospective, observational cohort.
Setting: Medical unit of an acute-care teaching hospital.
Synopsis: Oral signouts were audiotaped among IM house staff teams and the accompanying written signouts were collected for review of content. Signout sessions (n=88) included eight IM teams at one hospital and contained 503 patient signouts.
The median signout duration was 35 seconds (IQR 19-62) per patient. Key clinical information was present in just 62% of combined written or oral signouts. Most signouts included no questions from the recipient. Factors associated with higher rate of content inclusion included: familiarity with the patient, sense of responsibility (primary team vs. covering team), only one signout per day (as compared to sequential signout), presence of a senior resident, and comprehensive, written signouts.
Study limitations include the Hawthorne effect, as several participants mentioned that the presence of audiotape led to more comprehensive signouts than are typical. Also, the signout quality assessment in this study has not been validated with patient-safety outcomes.
Bottom line: Signouts among internal-medicine residents at this one hospital showed variability in terms of quantitative and qualitative information and often missed crucial information about patient care.
Citation: Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? Analysis of sign-out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248-255.
Clinical question: Do signouts vary in the quality and quantity of information, and what are the various factors affecting signout quality?
Background: Miscommunication during transfers of responsibility for hospitalized patients is common and can result in harm. Recommendations for safe and effective handoffs emphasize key content, clear communication, senior staff supervision, and adequate time for questions. Still, little is known about adherence to these recommendations in clinical practice.
Study design: Prospective, observational cohort.
Setting: Medical unit of an acute-care teaching hospital.
Synopsis: Oral signouts were audiotaped among IM house staff teams and the accompanying written signouts were collected for review of content. Signout sessions (n=88) included eight IM teams at one hospital and contained 503 patient signouts.
The median signout duration was 35 seconds (IQR 19-62) per patient. Key clinical information was present in just 62% of combined written or oral signouts. Most signouts included no questions from the recipient. Factors associated with higher rate of content inclusion included: familiarity with the patient, sense of responsibility (primary team vs. covering team), only one signout per day (as compared to sequential signout), presence of a senior resident, and comprehensive, written signouts.
Study limitations include the Hawthorne effect, as several participants mentioned that the presence of audiotape led to more comprehensive signouts than are typical. Also, the signout quality assessment in this study has not been validated with patient-safety outcomes.
Bottom line: Signouts among internal-medicine residents at this one hospital showed variability in terms of quantitative and qualitative information and often missed crucial information about patient care.
Citation: Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? Analysis of sign-out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248-255.
Clinical question: Do signouts vary in the quality and quantity of information, and what are the various factors affecting signout quality?
Background: Miscommunication during transfers of responsibility for hospitalized patients is common and can result in harm. Recommendations for safe and effective handoffs emphasize key content, clear communication, senior staff supervision, and adequate time for questions. Still, little is known about adherence to these recommendations in clinical practice.
Study design: Prospective, observational cohort.
Setting: Medical unit of an acute-care teaching hospital.
Synopsis: Oral signouts were audiotaped among IM house staff teams and the accompanying written signouts were collected for review of content. Signout sessions (n=88) included eight IM teams at one hospital and contained 503 patient signouts.
The median signout duration was 35 seconds (IQR 19-62) per patient. Key clinical information was present in just 62% of combined written or oral signouts. Most signouts included no questions from the recipient. Factors associated with higher rate of content inclusion included: familiarity with the patient, sense of responsibility (primary team vs. covering team), only one signout per day (as compared to sequential signout), presence of a senior resident, and comprehensive, written signouts.
Study limitations include the Hawthorne effect, as several participants mentioned that the presence of audiotape led to more comprehensive signouts than are typical. Also, the signout quality assessment in this study has not been validated with patient-safety outcomes.
Bottom line: Signouts among internal-medicine residents at this one hospital showed variability in terms of quantitative and qualitative information and often missed crucial information about patient care.
Citation: Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? Analysis of sign-out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248-255.
Emergency Department Signout via Voicemail Yields Mixed Reviews
Clinical question: How does traditional, oral signout from emergency providers to inpatient medicine physicians compare to dictated, voicemail signout?
Background: Communication failures contribute to errors in care transition from ED to inpatient medicine units. Signout between ED providers and internal medicine (IM) physicians is typically oral (“synchronous communication”). It is not known how dictated signout to a voicemail system (“asynchronous communication”) affects the quality and safety of handoff communications.
Study design: Prospective, pre-post analysis.
Setting: A 944-bed urban academic medical center in Connecticut.
Synopsis: Surveys were administered to all IM and ED providers before and after the implementation of a voicemail signout system. In the new system, ED providers dictated signout for stable patients, rather than giving traditional synchronous telephone signout. It was the responsibility of the admitting IM physician to listen to the voicemail after receiving a text notification that a patient was being admitted.
ED providers recorded signouts in 89.5% of medicine admissions. However, voicemails were accessed only 58.5% of the time by receiving physicians. All ED providers and 56% of IM physicians believed signout was easier following the voicemail intervention. Overall, ED providers gave the quality, content, and accuracy of their signout communication higher ratings than IM physicians did; 69% of all providers felt the interaction among participants was worse following the intervention. There was no change in the rate of perceived adverse events or ICU transfers within 24 hours after admission.
This intervention was a QI initiative at a single center. Mixed results and small sample size limit generalizability of the study.
Bottom line: Asynchronous signout by voicemail increased efficiency, particularly among ED providers but decreased perceived quality of interaction between medical providers without obviously affecting patient safety.
Citation: Horwitz LI, Parwani V, Shah NR, et al. Evaluation of an asynchronous physician voicemail sign-out for emergency department admissions. Ann Emerg Med. 2009;54:368-378.
Clinical question: How does traditional, oral signout from emergency providers to inpatient medicine physicians compare to dictated, voicemail signout?
Background: Communication failures contribute to errors in care transition from ED to inpatient medicine units. Signout between ED providers and internal medicine (IM) physicians is typically oral (“synchronous communication”). It is not known how dictated signout to a voicemail system (“asynchronous communication”) affects the quality and safety of handoff communications.
Study design: Prospective, pre-post analysis.
Setting: A 944-bed urban academic medical center in Connecticut.
Synopsis: Surveys were administered to all IM and ED providers before and after the implementation of a voicemail signout system. In the new system, ED providers dictated signout for stable patients, rather than giving traditional synchronous telephone signout. It was the responsibility of the admitting IM physician to listen to the voicemail after receiving a text notification that a patient was being admitted.
ED providers recorded signouts in 89.5% of medicine admissions. However, voicemails were accessed only 58.5% of the time by receiving physicians. All ED providers and 56% of IM physicians believed signout was easier following the voicemail intervention. Overall, ED providers gave the quality, content, and accuracy of their signout communication higher ratings than IM physicians did; 69% of all providers felt the interaction among participants was worse following the intervention. There was no change in the rate of perceived adverse events or ICU transfers within 24 hours after admission.
This intervention was a QI initiative at a single center. Mixed results and small sample size limit generalizability of the study.
Bottom line: Asynchronous signout by voicemail increased efficiency, particularly among ED providers but decreased perceived quality of interaction between medical providers without obviously affecting patient safety.
Citation: Horwitz LI, Parwani V, Shah NR, et al. Evaluation of an asynchronous physician voicemail sign-out for emergency department admissions. Ann Emerg Med. 2009;54:368-378.
Clinical question: How does traditional, oral signout from emergency providers to inpatient medicine physicians compare to dictated, voicemail signout?
Background: Communication failures contribute to errors in care transition from ED to inpatient medicine units. Signout between ED providers and internal medicine (IM) physicians is typically oral (“synchronous communication”). It is not known how dictated signout to a voicemail system (“asynchronous communication”) affects the quality and safety of handoff communications.
Study design: Prospective, pre-post analysis.
Setting: A 944-bed urban academic medical center in Connecticut.
Synopsis: Surveys were administered to all IM and ED providers before and after the implementation of a voicemail signout system. In the new system, ED providers dictated signout for stable patients, rather than giving traditional synchronous telephone signout. It was the responsibility of the admitting IM physician to listen to the voicemail after receiving a text notification that a patient was being admitted.
ED providers recorded signouts in 89.5% of medicine admissions. However, voicemails were accessed only 58.5% of the time by receiving physicians. All ED providers and 56% of IM physicians believed signout was easier following the voicemail intervention. Overall, ED providers gave the quality, content, and accuracy of their signout communication higher ratings than IM physicians did; 69% of all providers felt the interaction among participants was worse following the intervention. There was no change in the rate of perceived adverse events or ICU transfers within 24 hours after admission.
This intervention was a QI initiative at a single center. Mixed results and small sample size limit generalizability of the study.
Bottom line: Asynchronous signout by voicemail increased efficiency, particularly among ED providers but decreased perceived quality of interaction between medical providers without obviously affecting patient safety.
Citation: Horwitz LI, Parwani V, Shah NR, et al. Evaluation of an asynchronous physician voicemail sign-out for emergency department admissions. Ann Emerg Med. 2009;54:368-378.
Emergency Department “Boarding” Results in Undesirable Events
Clinical question: What is the frequency and nature of undesirable events experienced by patients who “board” in the ED?
Background: Hospital crowding results in patients spending extended amounts of time—also known as “boarding”—in the ED as they wait for an inpatient bed. Prior studies have shown that longer ED boarding times are associated with adverse outcomes. Few studies have examined the nature and frequency of undesirable events that patients experience while boarding.
Study design: Retrospective chart review.
Setting: Urban academic medical center.
Synopsis: In this pilot study, authors reviewed the charts of patients who were treated in the ED and subsequently admitted to the hospital on three different days during the study period (n=151). More than a quarter (27.8%) of patients experienced an undesirable event, such as missing a scheduled medication, while they were boarding. Older patients, those with comorbid illnesses, and those who endured prolonged boarding times (greater than six hours) were more likely to experience an undesirable event. In addition, 3.3% of patients experienced such adverse events as suboptimal blood pressure control, hypotension, hypoxia, or arrhythmia.
This study was performed at a single center and lacks a comparison group (i.e., nonboarded patients). It is intended to serve as an exploratory study for future analysis of adverse events in boarded patients.
Bottom line: Undesirable events are common among boarded patients, although it is unknown whether they are more common than in nonboarded patients.
Citation: Liu SW, Thomas SH, Gordon JA, Hamedani AG, Weissman JS. A pilot study examining undesirable events among emergency-department boarded patients awaiting inpatient beds. Ann Emerg Med. 2009;54(3):381-385.
Clinical question: What is the frequency and nature of undesirable events experienced by patients who “board” in the ED?
Background: Hospital crowding results in patients spending extended amounts of time—also known as “boarding”—in the ED as they wait for an inpatient bed. Prior studies have shown that longer ED boarding times are associated with adverse outcomes. Few studies have examined the nature and frequency of undesirable events that patients experience while boarding.
Study design: Retrospective chart review.
Setting: Urban academic medical center.
Synopsis: In this pilot study, authors reviewed the charts of patients who were treated in the ED and subsequently admitted to the hospital on three different days during the study period (n=151). More than a quarter (27.8%) of patients experienced an undesirable event, such as missing a scheduled medication, while they were boarding. Older patients, those with comorbid illnesses, and those who endured prolonged boarding times (greater than six hours) were more likely to experience an undesirable event. In addition, 3.3% of patients experienced such adverse events as suboptimal blood pressure control, hypotension, hypoxia, or arrhythmia.
This study was performed at a single center and lacks a comparison group (i.e., nonboarded patients). It is intended to serve as an exploratory study for future analysis of adverse events in boarded patients.
Bottom line: Undesirable events are common among boarded patients, although it is unknown whether they are more common than in nonboarded patients.
Citation: Liu SW, Thomas SH, Gordon JA, Hamedani AG, Weissman JS. A pilot study examining undesirable events among emergency-department boarded patients awaiting inpatient beds. Ann Emerg Med. 2009;54(3):381-385.
Clinical question: What is the frequency and nature of undesirable events experienced by patients who “board” in the ED?
Background: Hospital crowding results in patients spending extended amounts of time—also known as “boarding”—in the ED as they wait for an inpatient bed. Prior studies have shown that longer ED boarding times are associated with adverse outcomes. Few studies have examined the nature and frequency of undesirable events that patients experience while boarding.
Study design: Retrospective chart review.
Setting: Urban academic medical center.
Synopsis: In this pilot study, authors reviewed the charts of patients who were treated in the ED and subsequently admitted to the hospital on three different days during the study period (n=151). More than a quarter (27.8%) of patients experienced an undesirable event, such as missing a scheduled medication, while they were boarding. Older patients, those with comorbid illnesses, and those who endured prolonged boarding times (greater than six hours) were more likely to experience an undesirable event. In addition, 3.3% of patients experienced such adverse events as suboptimal blood pressure control, hypotension, hypoxia, or arrhythmia.
This study was performed at a single center and lacks a comparison group (i.e., nonboarded patients). It is intended to serve as an exploratory study for future analysis of adverse events in boarded patients.
Bottom line: Undesirable events are common among boarded patients, although it is unknown whether they are more common than in nonboarded patients.
Citation: Liu SW, Thomas SH, Gordon JA, Hamedani AG, Weissman JS. A pilot study examining undesirable events among emergency-department boarded patients awaiting inpatient beds. Ann Emerg Med. 2009;54(3):381-385.
Decreased ICU Duty Hours Does Not Affect Patient Mortality
Clinical question: Does the reduction in work hours for residents affect mortality in medical and surgical ICUs?
Background: A reduction in work hours for residents was enforced in July 2003. Several prior studies using administrative or claims data did not show an association of the reduced work hours for residents with mortality in teaching hospitals when compared with nonteaching hospitals.
Study design: Observational retrospective registry cohort.
Setting: Twelve academic, 12 community, and 16 nonteaching hospitals in the U.S.
Synopsis: Data from 230,151 patients were extracted as post-hoc analysis from a voluntary clinical registry that uses a well-validated severity-of-illness scoring system. The exposure was defined as date of admission to ICU within two years before and after the reform. Hospitals were categorized as academic, community with residents, or nonteaching. Sophisticated statistical analyses were performed, including interaction terms for teaching status and time. To test the effect the reduced work hours had on mortality, the mortality trends of academic hospitals and community hospitals with residents were compared with the baseline trend of nonteaching hospitals. After risk adjustments, all hospitals had improved in-hospital and ICU mortality after the reform. None of the statistical improvements were significantly different.
Study limitations include the selection bias, as only highly motivated hospitals participating in the registry were included, and misclassification bias, as not all hospitals implemented the reform at the same time. Nevertheless, this study supports the consistent literature on the topic and adds a more robust assessment of severity of illness.
Bottom line: The restriction on resident duty hours does not appear to affect patient mortality.
Citation: Prasad M, Iwashyna TJ, Christie JD, et al. Effect of work-hours regulations on intensive care unit mortality in United States teaching hospitals. Crit Care Med. 2009;37(9):2564-2569.
Clinical question: Does the reduction in work hours for residents affect mortality in medical and surgical ICUs?
Background: A reduction in work hours for residents was enforced in July 2003. Several prior studies using administrative or claims data did not show an association of the reduced work hours for residents with mortality in teaching hospitals when compared with nonteaching hospitals.
Study design: Observational retrospective registry cohort.
Setting: Twelve academic, 12 community, and 16 nonteaching hospitals in the U.S.
Synopsis: Data from 230,151 patients were extracted as post-hoc analysis from a voluntary clinical registry that uses a well-validated severity-of-illness scoring system. The exposure was defined as date of admission to ICU within two years before and after the reform. Hospitals were categorized as academic, community with residents, or nonteaching. Sophisticated statistical analyses were performed, including interaction terms for teaching status and time. To test the effect the reduced work hours had on mortality, the mortality trends of academic hospitals and community hospitals with residents were compared with the baseline trend of nonteaching hospitals. After risk adjustments, all hospitals had improved in-hospital and ICU mortality after the reform. None of the statistical improvements were significantly different.
Study limitations include the selection bias, as only highly motivated hospitals participating in the registry were included, and misclassification bias, as not all hospitals implemented the reform at the same time. Nevertheless, this study supports the consistent literature on the topic and adds a more robust assessment of severity of illness.
Bottom line: The restriction on resident duty hours does not appear to affect patient mortality.
Citation: Prasad M, Iwashyna TJ, Christie JD, et al. Effect of work-hours regulations on intensive care unit mortality in United States teaching hospitals. Crit Care Med. 2009;37(9):2564-2569.
Clinical question: Does the reduction in work hours for residents affect mortality in medical and surgical ICUs?
Background: A reduction in work hours for residents was enforced in July 2003. Several prior studies using administrative or claims data did not show an association of the reduced work hours for residents with mortality in teaching hospitals when compared with nonteaching hospitals.
Study design: Observational retrospective registry cohort.
Setting: Twelve academic, 12 community, and 16 nonteaching hospitals in the U.S.
Synopsis: Data from 230,151 patients were extracted as post-hoc analysis from a voluntary clinical registry that uses a well-validated severity-of-illness scoring system. The exposure was defined as date of admission to ICU within two years before and after the reform. Hospitals were categorized as academic, community with residents, or nonteaching. Sophisticated statistical analyses were performed, including interaction terms for teaching status and time. To test the effect the reduced work hours had on mortality, the mortality trends of academic hospitals and community hospitals with residents were compared with the baseline trend of nonteaching hospitals. After risk adjustments, all hospitals had improved in-hospital and ICU mortality after the reform. None of the statistical improvements were significantly different.
Study limitations include the selection bias, as only highly motivated hospitals participating in the registry were included, and misclassification bias, as not all hospitals implemented the reform at the same time. Nevertheless, this study supports the consistent literature on the topic and adds a more robust assessment of severity of illness.
Bottom line: The restriction on resident duty hours does not appear to affect patient mortality.
Citation: Prasad M, Iwashyna TJ, Christie JD, et al. Effect of work-hours regulations on intensive care unit mortality in United States teaching hospitals. Crit Care Med. 2009;37(9):2564-2569.
In the Literature: January 2010
In This Edition
Literature at a Glance
A guide to this month’s studies
- Resident duty hours and ICU patient outcomes
- Effect of ER boarding on patient outcomes
- ED voicemail signout of patients
- Adequacy of patient signouts
- D-dimer use in patients with low suspicion of pulmonary embolism
- Patient involvement in medication reconciliation
- Effects of on-screen reminders on outcomes
Decreased ICU Duty Hours Does Not Affect Patient Mortality
Clinical question: Does the reduction in work hours for residents affect mortality in medical and surgical ICUs?
Background: A reduction in work hours for residents was enforced in July 2003. Several prior studies using administrative or claims data did not show an association of the reduced work hours for residents with mortality in teaching hospitals when compared with nonteaching hospitals.
Study design: Observational retrospective registry cohort.
Setting: Twelve academic, 12 community, and 16 nonteaching hospitals in the U.S.
Synopsis: Data from 230,151 patients were extracted as post-hoc analysis from a voluntary clinical registry that uses a well-validated severity-of-illness scoring system. The exposure was defined as date of admission to ICU within two years before and after the reform. Hospitals were categorized as academic, community with residents, or nonteaching. Sophisticated statistical analyses were performed, including interaction terms for teaching status and time. To test the effect the reduced work hours had on mortality, the mortality trends of academic hospitals and community hospitals with residents were compared with the baseline trend of nonteaching hospitals. After risk adjustments, all hospitals had improved in-hospital and ICU mortality after the reform. None of the statistical improvements were significantly different.
Study limitations include the selection bias, as only highly motivated hospitals participating in the registry were included, and misclassification bias, as not all hospitals implemented the reform at the same time. Nevertheless, this study supports the consistent literature on the topic and adds a more robust assessment of severity of illness.
Bottom line: The restriction on resident duty hours does not appear to affect patient mortality.
Citation: Prasad M, Iwashyna TJ, Christie JD, et al. Effect of work-hours regulations on intensive care unit mortality in United States teaching hospitals. Crit Care Med. 2009;37(9):2564-2569.
Emergency Department “Boarding” Results in Undesirable Events
Clinical question: What is the frequency and nature of undesirable events experienced by patients who “board” in the ED?
Background: Hospital crowding results in patients spending extended amounts of time—also known as “boarding”—in the ED as they wait for an inpatient bed. Prior studies have shown that longer ED boarding times are associated with adverse outcomes. Few studies have examined the nature and frequency of undesirable events that patients experience while boarding.
Study design: Retrospective chart review.
Setting: Urban academic medical center.
Synopsis: In this pilot study, authors reviewed the charts of patients who were treated in the ED and subsequently admitted to the hospital on three different days during the study period (n=151). More than a quarter (27.8%) of patients experienced an undesirable event, such as missing a scheduled medication, while they were boarding. Older patients, those with comorbid illnesses, and those who endured prolonged boarding times (greater than six hours) were more likely to experience an undesirable event. In addition, 3.3% of patients experienced such adverse events as suboptimal blood pressure control, hypotension, hypoxia, or arrhythmia.
This study was performed at a single center and lacks a comparison group (i.e., nonboarded patients). It is intended to serve as an exploratory study for future analysis of adverse events in boarded patients.
Bottom line: Undesirable events are common among boarded patients, although it is unknown whether they are more common than in nonboarded patients.
Citation: Liu SW, Thomas SH, Gordon JA, Hamedani AG, Weissman JS. A pilot study examining undesirable events among emergency-department boarded patients awaiting inpatient beds. Ann Emerg Med. 2009;54(3):381-385.
Emergency Department Signout via Voicemail Yields Mixed Reviews
Clinical question: How does traditional, oral signout from emergency providers to inpatient medicine physicians compare to dictated, voicemail signout?
Background: Communication failures contribute to errors in care transition from ED to inpatient medicine units. Signout between ED providers and internal medicine (IM) physicians is typically oral (“synchronous communication”). It is not known how dictated signout to a voicemail system (“asynchronous communication”) affects the quality and safety of handoff communications.
Study design: Prospective, pre-post analysis.
Setting: A 944-bed urban academic medical center in Connecticut.
Synopsis: Surveys were administered to all IM and ED providers before and after the implementation of a voicemail signout system. In the new system, ED providers dictated signout for stable patients, rather than giving traditional synchronous telephone signout. It was the responsibility of the admitting IM physician to listen to the voicemail after receiving a text notification that a patient was being admitted.
ED providers recorded signouts in 89.5% of medicine admissions. However, voicemails were accessed only 58.5% of the time by receiving physicians. All ED providers and 56% of IM physicians believed signout was easier following the voicemail intervention. Overall, ED providers gave the quality, content, and accuracy of their signout communication higher ratings than IM physicians did; 69% of all providers felt the interaction among participants was worse following the intervention. There was no change in the rate of perceived adverse events or ICU transfers within 24 hours after admission.
This intervention was a QI initiative at a single center. Mixed results and small sample size limit generalizability of the study.
Bottom line: Asynchronous signout by voicemail increased efficiency, particularly among ED providers but decreased perceived quality of interaction between medical providers without obviously affecting patient safety.
Citation: Horwitz LI, Parwani V, Shah NR, et al. Evaluation of an asynchronous physician voicemail sign-out for emergency department admissions. Ann Emerg Med. 2009;54:368-378.
Patient Signout Is Not Uniformly Comprehensive and Often Lacks Critical Information
Clinical question: Do signouts vary in the quality and quantity of information, and what are the various factors affecting signout quality?
Background: Miscommunication during transfers of responsibility for hospitalized patients is common and can result in harm. Recommendations for safe and effective handoffs emphasize key content, clear communication, senior staff supervision, and adequate time for questions. Still, little is known about adherence to these recommendations in clinical practice.
Study design: Prospective, observational cohort.
Setting: Medical unit of an acute-care teaching hospital.
Synopsis: Oral signouts were audiotaped among IM house staff teams and the accompanying written signouts were collected for review of content. Signout sessions (n=88) included eight IM teams at one hospital and contained 503 patient signouts.
The median signout duration was 35 seconds (IQR 19-62) per patient. Key clinical information was present in just 62% of combined written or oral signouts. Most signouts included no questions from the recipient. Factors associated with higher rate of content inclusion included: familiarity with the patient, sense of responsibility (primary team vs. covering team), only one signout per day (as compared to sequential signout), presence of a senior resident, and comprehensive, written signouts.
Study limitations include the Hawthorne effect, as several participants mentioned that the presence of audiotape led to more comprehensive signouts than are typical. Also, the signout quality assessment in this study has not been validated with patient-safety outcomes.
Bottom line: Signouts among internal-medicine residents at this one hospital showed variability in terms of quantitative and qualitative information and often missed crucial information about patient care.
Citation: Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? Analysis of sign-out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248-255.
Negative D-Dimer Test Can Safely Exclude Pulmonary Embolism in Patients at Low To Intermediate Clinical Risk
Clinical question: In patients with symptoms consistent with pulmonary embolism (PE), can evaluation with a clinical risk assessment tool and D-dimer assay identify patients who do not require CT angiography to exclude PE?
Background: D-dimer is a highly sensitive but nonspecific marker of VTE, and studies suggest that VTE can be ruled out without further imaging in patients with low clinical probability of disease and a negative D-dimer test. Nevertheless, this practice has not been adopted uniformly, and CT angiography (CTA) overuse continues.
Study design: Prospective registry cohort.
Setting: A 550-bed community teaching hospital in Chicago.
Synopsis: Consecutive patients presenting to the ED with symptoms suggestive of PE were evaluated with 1) revised Geneva score; 2) D-dimer assay; and 3) CTA. Among the 627 patients who underwent all three components of the evaluation, 44.8% were identified as low probability for PE by revised Geneva score, 52.6% as intermediate probability, and 2.6% as high probability. The overall prevalence of PE (using CTA as the gold standard) was very low (4.5%); just 2.1% of low-risk, 5.2% of intermediate-risk, and 31.2% of high-risk patients were ultimately found to have PE on CTA.
Using a cutoff of 1.2 mg/L, the D-dimer assay accurately detected all low- to intermediate-probability patients with PE (sensitivity and negative predictive value of 100%). One patient in the high probability group did have a PE, even though the patient had a D-dimer value <1.2 mg/L (sensitivity and NPV both 80%). Had diagnostic testing stopped after a negative D-dimer result in the low- to intermediate-probability patients, 172 CTAs (27%) would have been avoided.
Bottom line: In a low-prevalence cohort, no pulmonary emboli were identified by CTA in any patient with a low to intermediate clinical risk assessment and a negative quantitative D-dimer assay result.
Citation: Gupta RT, Kakarla RK, Kirshenbaum KJ, Tapson VF. D-dimers and efficacy of clinical risk estimation algorithms: sensitivity in evaluation of acute pulmonary embolism. AJR Am J Roentgenol. 2009;193(2):425-430.
Patient Participation in Medication Reconciliation at Discharge Helps Detect Prescribing Discrepancies
Clinical question: Does the inclusion of a medication adherence counseling session during a hospital discharge reconciliation process reduce discrepancies in the final medication regimen?
Background: Inadvertent medication prescribing errors are an important cause of preventable adverse drug events and commonly occur at transitions of care. Although medication reconciliation processes can identify errors, the best strategies for implementation remain unclear.
Study design: Prospective, observational cohort.
Setting: A 550-bed teaching hospital in the Netherlands.
Synopsis: Of 437 patients admitted to a pulmonary ward and screened for eligibility, 267 were included in the analysis. A pharmacy specialist reviewed all available community prescription records, inpatient documentation, and discharge medication lists in an effort to identify discrepancies. Potential errors were discussed with the prescriber. Then, the pharmacy specialist interviewed the patient and provided additional counseling. Any new discrepancies were discussed with the prescriber. All questions raised by the pharmacist were recorded, as were all subsequent prescriber interventions.
The primary outcome measure was the number of interventions made as a result of pharmacy review. A total of 940 questions were asked. At least one intervention was recorded for 87% of patients before counseling (mean 2.7 interventions/patient) and for 97% of patients after (mean 5.3 interventions/patient). Discrepancies were addressed for 63.7% of patients before counseling and 72.5% after. Pharmacotherapy was optimized for 67.2% of patients before counseling and 76.3% after.
Bottom line: Patient engagement in the medication reconciliation process incrementally improves the quality of the history and helps identify clinically meaningful discrepancies at the time of hospital discharge.
Citation: Karapinar-Carkit F, Borgsteede S, Zoer J, Smit HJ, Egberts AC, van den Bemt P. Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009;43(6):1001-1010.
Computer-Based Reminders Have Small to Modest Effect on Care Processes
Clinical question: Do on-screen, computer-based clinical reminders improve adherence to target processes of care or clinical outcomes?
Background: Gaps between practice guidelines and routine care are caused, in part, by the inability of clinicians to access or recall information at the point of care. Although automated reminder systems offer the promise of “just in time” recommendations, studies of electronic reminders have demonstrated mixed results.
Study design: Literature review and meta-analysis.
Setting: Multiple databases and information repositories, including MEDLINE, EMBASE, and CINAHL.
Synopsis: The authors conducted a literature search to identify randomized and quasi-randomized controlled trials measuring the effect of computer-based reminders on process measures or clinical outcomes. To avoid statistical challenges inherent in unit-of-analysis errors, the authors reported median improvement in process adherence or median change in clinical endpoints.
Out of a pool of 2,036 citations, 28 studies detailing 32 comparative analyses were included. Across the 28 studies, reminders resulted in a median improvement in target process adherence of 4.2% (3.3% for prescribing behavior, 2.8% for test ordering). Eight comparisons reported dichotomous clinical endpoints and collectively showed a median absolute improvement of 2.5%.
The greatest contribution to measured treatment effects came from large academic centers with well-established electronic health records and robust informatics departments. No characteristics of the reminder system or the clinical context were associated with the magnitude of impact. A potential limitation in reporting median effects across studies is that all studies were given equal weight.
Bottom line: Electronic reminders appear to have a small, positive effect on clinician adherence to recommended processes, although it is uncertain what contextual or design features are responsible for the greatest treatment effect.
Citation: Shojania K, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009(3):CD001096. TH
Pediatric HM Literature
Short Course of Oral Antibiotics Effective for Acute Osteomyelitis and Septic Arthritis in Children
By Mark Shen, MD
Clinical question: Is a short course (less than four weeks) of antibiotics effective for the treatment of acute osteomyelitis and septic arthritis?
Background: The optimal duration of treatment for acute bone and joint infections in children has not been assessed adequately in prospectively designed trials. Historically, intravenous (IV) antibiotics in four- to six-week durations have been recommended, although the evidence for this practice is limited. There is widespread variation in both the route of administration (oral vs. IV) and duration of this treatment.
Study design: Prospective cohort study.
Setting: Two children’s hospitals in Australia.
Synopsis: Seventy children ages 17 and under who presented to two tertiary-care children’s hospitals with osteomyelitis or septic arthritis were enrolled. Primary surgical drainage was performed for patients with septic arthritis. Intravenous antibiotics were administered for at least three days, and until clinical symptoms improved and the C-reactive protein levels had stabilized. Patients then were transitioned to oral antibiotics and discharged to complete a minimum of three weeks of therapy.
Fifty-nine percent of patients were converted to oral antibiotics by day three, 86% by day five of therapy. Based on clinical and hematologic assessment, 83% of patients had oral antibiotics stopped at the three-week followup and remained well through the 12-month follow-up period.
This study essentially involved prospective data collection for a cohort of children receiving standardized care. Although the results suggest that a majority of children can be treated with a three-week course of oral antibiotics, the results would have been further strengthened by an explicit protocol with well-defined criteria for the oral to IV transition and cessation of antibiotic therapy. Additional limitations include pathogens and antibiotic choices that might not be applicable to North American populations.
Bottom line: After initial intravenous therapy, a three-week course of oral antibiotics can be effective for acute osteomyelitis and septic arthritis in children.
Citation: Jagodzinski NA, Kanwar R, Graham K, Bache CE. Prospective evaluation of a shortened regimen of treatment for acute osteomyelitis and septic arthritis in children. J Pediatr Orthop. 2009;29(5):518-525.
In This Edition
Literature at a Glance
A guide to this month’s studies
- Resident duty hours and ICU patient outcomes
- Effect of ER boarding on patient outcomes
- ED voicemail signout of patients
- Adequacy of patient signouts
- D-dimer use in patients with low suspicion of pulmonary embolism
- Patient involvement in medication reconciliation
- Effects of on-screen reminders on outcomes
Decreased ICU Duty Hours Does Not Affect Patient Mortality
Clinical question: Does the reduction in work hours for residents affect mortality in medical and surgical ICUs?
Background: A reduction in work hours for residents was enforced in July 2003. Several prior studies using administrative or claims data did not show an association of the reduced work hours for residents with mortality in teaching hospitals when compared with nonteaching hospitals.
Study design: Observational retrospective registry cohort.
Setting: Twelve academic, 12 community, and 16 nonteaching hospitals in the U.S.
Synopsis: Data from 230,151 patients were extracted as post-hoc analysis from a voluntary clinical registry that uses a well-validated severity-of-illness scoring system. The exposure was defined as date of admission to ICU within two years before and after the reform. Hospitals were categorized as academic, community with residents, or nonteaching. Sophisticated statistical analyses were performed, including interaction terms for teaching status and time. To test the effect the reduced work hours had on mortality, the mortality trends of academic hospitals and community hospitals with residents were compared with the baseline trend of nonteaching hospitals. After risk adjustments, all hospitals had improved in-hospital and ICU mortality after the reform. None of the statistical improvements were significantly different.
Study limitations include the selection bias, as only highly motivated hospitals participating in the registry were included, and misclassification bias, as not all hospitals implemented the reform at the same time. Nevertheless, this study supports the consistent literature on the topic and adds a more robust assessment of severity of illness.
Bottom line: The restriction on resident duty hours does not appear to affect patient mortality.
Citation: Prasad M, Iwashyna TJ, Christie JD, et al. Effect of work-hours regulations on intensive care unit mortality in United States teaching hospitals. Crit Care Med. 2009;37(9):2564-2569.
Emergency Department “Boarding” Results in Undesirable Events
Clinical question: What is the frequency and nature of undesirable events experienced by patients who “board” in the ED?
Background: Hospital crowding results in patients spending extended amounts of time—also known as “boarding”—in the ED as they wait for an inpatient bed. Prior studies have shown that longer ED boarding times are associated with adverse outcomes. Few studies have examined the nature and frequency of undesirable events that patients experience while boarding.
Study design: Retrospective chart review.
Setting: Urban academic medical center.
Synopsis: In this pilot study, authors reviewed the charts of patients who were treated in the ED and subsequently admitted to the hospital on three different days during the study period (n=151). More than a quarter (27.8%) of patients experienced an undesirable event, such as missing a scheduled medication, while they were boarding. Older patients, those with comorbid illnesses, and those who endured prolonged boarding times (greater than six hours) were more likely to experience an undesirable event. In addition, 3.3% of patients experienced such adverse events as suboptimal blood pressure control, hypotension, hypoxia, or arrhythmia.
This study was performed at a single center and lacks a comparison group (i.e., nonboarded patients). It is intended to serve as an exploratory study for future analysis of adverse events in boarded patients.
Bottom line: Undesirable events are common among boarded patients, although it is unknown whether they are more common than in nonboarded patients.
Citation: Liu SW, Thomas SH, Gordon JA, Hamedani AG, Weissman JS. A pilot study examining undesirable events among emergency-department boarded patients awaiting inpatient beds. Ann Emerg Med. 2009;54(3):381-385.
Emergency Department Signout via Voicemail Yields Mixed Reviews
Clinical question: How does traditional, oral signout from emergency providers to inpatient medicine physicians compare to dictated, voicemail signout?
Background: Communication failures contribute to errors in care transition from ED to inpatient medicine units. Signout between ED providers and internal medicine (IM) physicians is typically oral (“synchronous communication”). It is not known how dictated signout to a voicemail system (“asynchronous communication”) affects the quality and safety of handoff communications.
Study design: Prospective, pre-post analysis.
Setting: A 944-bed urban academic medical center in Connecticut.
Synopsis: Surveys were administered to all IM and ED providers before and after the implementation of a voicemail signout system. In the new system, ED providers dictated signout for stable patients, rather than giving traditional synchronous telephone signout. It was the responsibility of the admitting IM physician to listen to the voicemail after receiving a text notification that a patient was being admitted.
ED providers recorded signouts in 89.5% of medicine admissions. However, voicemails were accessed only 58.5% of the time by receiving physicians. All ED providers and 56% of IM physicians believed signout was easier following the voicemail intervention. Overall, ED providers gave the quality, content, and accuracy of their signout communication higher ratings than IM physicians did; 69% of all providers felt the interaction among participants was worse following the intervention. There was no change in the rate of perceived adverse events or ICU transfers within 24 hours after admission.
This intervention was a QI initiative at a single center. Mixed results and small sample size limit generalizability of the study.
Bottom line: Asynchronous signout by voicemail increased efficiency, particularly among ED providers but decreased perceived quality of interaction between medical providers without obviously affecting patient safety.
Citation: Horwitz LI, Parwani V, Shah NR, et al. Evaluation of an asynchronous physician voicemail sign-out for emergency department admissions. Ann Emerg Med. 2009;54:368-378.
Patient Signout Is Not Uniformly Comprehensive and Often Lacks Critical Information
Clinical question: Do signouts vary in the quality and quantity of information, and what are the various factors affecting signout quality?
Background: Miscommunication during transfers of responsibility for hospitalized patients is common and can result in harm. Recommendations for safe and effective handoffs emphasize key content, clear communication, senior staff supervision, and adequate time for questions. Still, little is known about adherence to these recommendations in clinical practice.
Study design: Prospective, observational cohort.
Setting: Medical unit of an acute-care teaching hospital.
Synopsis: Oral signouts were audiotaped among IM house staff teams and the accompanying written signouts were collected for review of content. Signout sessions (n=88) included eight IM teams at one hospital and contained 503 patient signouts.
The median signout duration was 35 seconds (IQR 19-62) per patient. Key clinical information was present in just 62% of combined written or oral signouts. Most signouts included no questions from the recipient. Factors associated with higher rate of content inclusion included: familiarity with the patient, sense of responsibility (primary team vs. covering team), only one signout per day (as compared to sequential signout), presence of a senior resident, and comprehensive, written signouts.
Study limitations include the Hawthorne effect, as several participants mentioned that the presence of audiotape led to more comprehensive signouts than are typical. Also, the signout quality assessment in this study has not been validated with patient-safety outcomes.
Bottom line: Signouts among internal-medicine residents at this one hospital showed variability in terms of quantitative and qualitative information and often missed crucial information about patient care.
Citation: Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? Analysis of sign-out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248-255.
Negative D-Dimer Test Can Safely Exclude Pulmonary Embolism in Patients at Low To Intermediate Clinical Risk
Clinical question: In patients with symptoms consistent with pulmonary embolism (PE), can evaluation with a clinical risk assessment tool and D-dimer assay identify patients who do not require CT angiography to exclude PE?
Background: D-dimer is a highly sensitive but nonspecific marker of VTE, and studies suggest that VTE can be ruled out without further imaging in patients with low clinical probability of disease and a negative D-dimer test. Nevertheless, this practice has not been adopted uniformly, and CT angiography (CTA) overuse continues.
Study design: Prospective registry cohort.
Setting: A 550-bed community teaching hospital in Chicago.
Synopsis: Consecutive patients presenting to the ED with symptoms suggestive of PE were evaluated with 1) revised Geneva score; 2) D-dimer assay; and 3) CTA. Among the 627 patients who underwent all three components of the evaluation, 44.8% were identified as low probability for PE by revised Geneva score, 52.6% as intermediate probability, and 2.6% as high probability. The overall prevalence of PE (using CTA as the gold standard) was very low (4.5%); just 2.1% of low-risk, 5.2% of intermediate-risk, and 31.2% of high-risk patients were ultimately found to have PE on CTA.
Using a cutoff of 1.2 mg/L, the D-dimer assay accurately detected all low- to intermediate-probability patients with PE (sensitivity and negative predictive value of 100%). One patient in the high probability group did have a PE, even though the patient had a D-dimer value <1.2 mg/L (sensitivity and NPV both 80%). Had diagnostic testing stopped after a negative D-dimer result in the low- to intermediate-probability patients, 172 CTAs (27%) would have been avoided.
Bottom line: In a low-prevalence cohort, no pulmonary emboli were identified by CTA in any patient with a low to intermediate clinical risk assessment and a negative quantitative D-dimer assay result.
Citation: Gupta RT, Kakarla RK, Kirshenbaum KJ, Tapson VF. D-dimers and efficacy of clinical risk estimation algorithms: sensitivity in evaluation of acute pulmonary embolism. AJR Am J Roentgenol. 2009;193(2):425-430.
Patient Participation in Medication Reconciliation at Discharge Helps Detect Prescribing Discrepancies
Clinical question: Does the inclusion of a medication adherence counseling session during a hospital discharge reconciliation process reduce discrepancies in the final medication regimen?
Background: Inadvertent medication prescribing errors are an important cause of preventable adverse drug events and commonly occur at transitions of care. Although medication reconciliation processes can identify errors, the best strategies for implementation remain unclear.
Study design: Prospective, observational cohort.
Setting: A 550-bed teaching hospital in the Netherlands.
Synopsis: Of 437 patients admitted to a pulmonary ward and screened for eligibility, 267 were included in the analysis. A pharmacy specialist reviewed all available community prescription records, inpatient documentation, and discharge medication lists in an effort to identify discrepancies. Potential errors were discussed with the prescriber. Then, the pharmacy specialist interviewed the patient and provided additional counseling. Any new discrepancies were discussed with the prescriber. All questions raised by the pharmacist were recorded, as were all subsequent prescriber interventions.
The primary outcome measure was the number of interventions made as a result of pharmacy review. A total of 940 questions were asked. At least one intervention was recorded for 87% of patients before counseling (mean 2.7 interventions/patient) and for 97% of patients after (mean 5.3 interventions/patient). Discrepancies were addressed for 63.7% of patients before counseling and 72.5% after. Pharmacotherapy was optimized for 67.2% of patients before counseling and 76.3% after.
Bottom line: Patient engagement in the medication reconciliation process incrementally improves the quality of the history and helps identify clinically meaningful discrepancies at the time of hospital discharge.
Citation: Karapinar-Carkit F, Borgsteede S, Zoer J, Smit HJ, Egberts AC, van den Bemt P. Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009;43(6):1001-1010.
Computer-Based Reminders Have Small to Modest Effect on Care Processes
Clinical question: Do on-screen, computer-based clinical reminders improve adherence to target processes of care or clinical outcomes?
Background: Gaps between practice guidelines and routine care are caused, in part, by the inability of clinicians to access or recall information at the point of care. Although automated reminder systems offer the promise of “just in time” recommendations, studies of electronic reminders have demonstrated mixed results.
Study design: Literature review and meta-analysis.
Setting: Multiple databases and information repositories, including MEDLINE, EMBASE, and CINAHL.
Synopsis: The authors conducted a literature search to identify randomized and quasi-randomized controlled trials measuring the effect of computer-based reminders on process measures or clinical outcomes. To avoid statistical challenges inherent in unit-of-analysis errors, the authors reported median improvement in process adherence or median change in clinical endpoints.
Out of a pool of 2,036 citations, 28 studies detailing 32 comparative analyses were included. Across the 28 studies, reminders resulted in a median improvement in target process adherence of 4.2% (3.3% for prescribing behavior, 2.8% for test ordering). Eight comparisons reported dichotomous clinical endpoints and collectively showed a median absolute improvement of 2.5%.
The greatest contribution to measured treatment effects came from large academic centers with well-established electronic health records and robust informatics departments. No characteristics of the reminder system or the clinical context were associated with the magnitude of impact. A potential limitation in reporting median effects across studies is that all studies were given equal weight.
Bottom line: Electronic reminders appear to have a small, positive effect on clinician adherence to recommended processes, although it is uncertain what contextual or design features are responsible for the greatest treatment effect.
Citation: Shojania K, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009(3):CD001096. TH
Pediatric HM Literature
Short Course of Oral Antibiotics Effective for Acute Osteomyelitis and Septic Arthritis in Children
By Mark Shen, MD
Clinical question: Is a short course (less than four weeks) of antibiotics effective for the treatment of acute osteomyelitis and septic arthritis?
Background: The optimal duration of treatment for acute bone and joint infections in children has not been assessed adequately in prospectively designed trials. Historically, intravenous (IV) antibiotics in four- to six-week durations have been recommended, although the evidence for this practice is limited. There is widespread variation in both the route of administration (oral vs. IV) and duration of this treatment.
Study design: Prospective cohort study.
Setting: Two children’s hospitals in Australia.
Synopsis: Seventy children ages 17 and under who presented to two tertiary-care children’s hospitals with osteomyelitis or septic arthritis were enrolled. Primary surgical drainage was performed for patients with septic arthritis. Intravenous antibiotics were administered for at least three days, and until clinical symptoms improved and the C-reactive protein levels had stabilized. Patients then were transitioned to oral antibiotics and discharged to complete a minimum of three weeks of therapy.
Fifty-nine percent of patients were converted to oral antibiotics by day three, 86% by day five of therapy. Based on clinical and hematologic assessment, 83% of patients had oral antibiotics stopped at the three-week followup and remained well through the 12-month follow-up period.
This study essentially involved prospective data collection for a cohort of children receiving standardized care. Although the results suggest that a majority of children can be treated with a three-week course of oral antibiotics, the results would have been further strengthened by an explicit protocol with well-defined criteria for the oral to IV transition and cessation of antibiotic therapy. Additional limitations include pathogens and antibiotic choices that might not be applicable to North American populations.
Bottom line: After initial intravenous therapy, a three-week course of oral antibiotics can be effective for acute osteomyelitis and septic arthritis in children.
Citation: Jagodzinski NA, Kanwar R, Graham K, Bache CE. Prospective evaluation of a shortened regimen of treatment for acute osteomyelitis and septic arthritis in children. J Pediatr Orthop. 2009;29(5):518-525.
In This Edition
Literature at a Glance
A guide to this month’s studies
- Resident duty hours and ICU patient outcomes
- Effect of ER boarding on patient outcomes
- ED voicemail signout of patients
- Adequacy of patient signouts
- D-dimer use in patients with low suspicion of pulmonary embolism
- Patient involvement in medication reconciliation
- Effects of on-screen reminders on outcomes
Decreased ICU Duty Hours Does Not Affect Patient Mortality
Clinical question: Does the reduction in work hours for residents affect mortality in medical and surgical ICUs?
Background: A reduction in work hours for residents was enforced in July 2003. Several prior studies using administrative or claims data did not show an association of the reduced work hours for residents with mortality in teaching hospitals when compared with nonteaching hospitals.
Study design: Observational retrospective registry cohort.
Setting: Twelve academic, 12 community, and 16 nonteaching hospitals in the U.S.
Synopsis: Data from 230,151 patients were extracted as post-hoc analysis from a voluntary clinical registry that uses a well-validated severity-of-illness scoring system. The exposure was defined as date of admission to ICU within two years before and after the reform. Hospitals were categorized as academic, community with residents, or nonteaching. Sophisticated statistical analyses were performed, including interaction terms for teaching status and time. To test the effect the reduced work hours had on mortality, the mortality trends of academic hospitals and community hospitals with residents were compared with the baseline trend of nonteaching hospitals. After risk adjustments, all hospitals had improved in-hospital and ICU mortality after the reform. None of the statistical improvements were significantly different.
Study limitations include the selection bias, as only highly motivated hospitals participating in the registry were included, and misclassification bias, as not all hospitals implemented the reform at the same time. Nevertheless, this study supports the consistent literature on the topic and adds a more robust assessment of severity of illness.
Bottom line: The restriction on resident duty hours does not appear to affect patient mortality.
Citation: Prasad M, Iwashyna TJ, Christie JD, et al. Effect of work-hours regulations on intensive care unit mortality in United States teaching hospitals. Crit Care Med. 2009;37(9):2564-2569.
Emergency Department “Boarding” Results in Undesirable Events
Clinical question: What is the frequency and nature of undesirable events experienced by patients who “board” in the ED?
Background: Hospital crowding results in patients spending extended amounts of time—also known as “boarding”—in the ED as they wait for an inpatient bed. Prior studies have shown that longer ED boarding times are associated with adverse outcomes. Few studies have examined the nature and frequency of undesirable events that patients experience while boarding.
Study design: Retrospective chart review.
Setting: Urban academic medical center.
Synopsis: In this pilot study, authors reviewed the charts of patients who were treated in the ED and subsequently admitted to the hospital on three different days during the study period (n=151). More than a quarter (27.8%) of patients experienced an undesirable event, such as missing a scheduled medication, while they were boarding. Older patients, those with comorbid illnesses, and those who endured prolonged boarding times (greater than six hours) were more likely to experience an undesirable event. In addition, 3.3% of patients experienced such adverse events as suboptimal blood pressure control, hypotension, hypoxia, or arrhythmia.
This study was performed at a single center and lacks a comparison group (i.e., nonboarded patients). It is intended to serve as an exploratory study for future analysis of adverse events in boarded patients.
Bottom line: Undesirable events are common among boarded patients, although it is unknown whether they are more common than in nonboarded patients.
Citation: Liu SW, Thomas SH, Gordon JA, Hamedani AG, Weissman JS. A pilot study examining undesirable events among emergency-department boarded patients awaiting inpatient beds. Ann Emerg Med. 2009;54(3):381-385.
Emergency Department Signout via Voicemail Yields Mixed Reviews
Clinical question: How does traditional, oral signout from emergency providers to inpatient medicine physicians compare to dictated, voicemail signout?
Background: Communication failures contribute to errors in care transition from ED to inpatient medicine units. Signout between ED providers and internal medicine (IM) physicians is typically oral (“synchronous communication”). It is not known how dictated signout to a voicemail system (“asynchronous communication”) affects the quality and safety of handoff communications.
Study design: Prospective, pre-post analysis.
Setting: A 944-bed urban academic medical center in Connecticut.
Synopsis: Surveys were administered to all IM and ED providers before and after the implementation of a voicemail signout system. In the new system, ED providers dictated signout for stable patients, rather than giving traditional synchronous telephone signout. It was the responsibility of the admitting IM physician to listen to the voicemail after receiving a text notification that a patient was being admitted.
ED providers recorded signouts in 89.5% of medicine admissions. However, voicemails were accessed only 58.5% of the time by receiving physicians. All ED providers and 56% of IM physicians believed signout was easier following the voicemail intervention. Overall, ED providers gave the quality, content, and accuracy of their signout communication higher ratings than IM physicians did; 69% of all providers felt the interaction among participants was worse following the intervention. There was no change in the rate of perceived adverse events or ICU transfers within 24 hours after admission.
This intervention was a QI initiative at a single center. Mixed results and small sample size limit generalizability of the study.
Bottom line: Asynchronous signout by voicemail increased efficiency, particularly among ED providers but decreased perceived quality of interaction between medical providers without obviously affecting patient safety.
Citation: Horwitz LI, Parwani V, Shah NR, et al. Evaluation of an asynchronous physician voicemail sign-out for emergency department admissions. Ann Emerg Med. 2009;54:368-378.
Patient Signout Is Not Uniformly Comprehensive and Often Lacks Critical Information
Clinical question: Do signouts vary in the quality and quantity of information, and what are the various factors affecting signout quality?
Background: Miscommunication during transfers of responsibility for hospitalized patients is common and can result in harm. Recommendations for safe and effective handoffs emphasize key content, clear communication, senior staff supervision, and adequate time for questions. Still, little is known about adherence to these recommendations in clinical practice.
Study design: Prospective, observational cohort.
Setting: Medical unit of an acute-care teaching hospital.
Synopsis: Oral signouts were audiotaped among IM house staff teams and the accompanying written signouts were collected for review of content. Signout sessions (n=88) included eight IM teams at one hospital and contained 503 patient signouts.
The median signout duration was 35 seconds (IQR 19-62) per patient. Key clinical information was present in just 62% of combined written or oral signouts. Most signouts included no questions from the recipient. Factors associated with higher rate of content inclusion included: familiarity with the patient, sense of responsibility (primary team vs. covering team), only one signout per day (as compared to sequential signout), presence of a senior resident, and comprehensive, written signouts.
Study limitations include the Hawthorne effect, as several participants mentioned that the presence of audiotape led to more comprehensive signouts than are typical. Also, the signout quality assessment in this study has not been validated with patient-safety outcomes.
Bottom line: Signouts among internal-medicine residents at this one hospital showed variability in terms of quantitative and qualitative information and often missed crucial information about patient care.
Citation: Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? Analysis of sign-out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248-255.
Negative D-Dimer Test Can Safely Exclude Pulmonary Embolism in Patients at Low To Intermediate Clinical Risk
Clinical question: In patients with symptoms consistent with pulmonary embolism (PE), can evaluation with a clinical risk assessment tool and D-dimer assay identify patients who do not require CT angiography to exclude PE?
Background: D-dimer is a highly sensitive but nonspecific marker of VTE, and studies suggest that VTE can be ruled out without further imaging in patients with low clinical probability of disease and a negative D-dimer test. Nevertheless, this practice has not been adopted uniformly, and CT angiography (CTA) overuse continues.
Study design: Prospective registry cohort.
Setting: A 550-bed community teaching hospital in Chicago.
Synopsis: Consecutive patients presenting to the ED with symptoms suggestive of PE were evaluated with 1) revised Geneva score; 2) D-dimer assay; and 3) CTA. Among the 627 patients who underwent all three components of the evaluation, 44.8% were identified as low probability for PE by revised Geneva score, 52.6% as intermediate probability, and 2.6% as high probability. The overall prevalence of PE (using CTA as the gold standard) was very low (4.5%); just 2.1% of low-risk, 5.2% of intermediate-risk, and 31.2% of high-risk patients were ultimately found to have PE on CTA.
Using a cutoff of 1.2 mg/L, the D-dimer assay accurately detected all low- to intermediate-probability patients with PE (sensitivity and negative predictive value of 100%). One patient in the high probability group did have a PE, even though the patient had a D-dimer value <1.2 mg/L (sensitivity and NPV both 80%). Had diagnostic testing stopped after a negative D-dimer result in the low- to intermediate-probability patients, 172 CTAs (27%) would have been avoided.
Bottom line: In a low-prevalence cohort, no pulmonary emboli were identified by CTA in any patient with a low to intermediate clinical risk assessment and a negative quantitative D-dimer assay result.
Citation: Gupta RT, Kakarla RK, Kirshenbaum KJ, Tapson VF. D-dimers and efficacy of clinical risk estimation algorithms: sensitivity in evaluation of acute pulmonary embolism. AJR Am J Roentgenol. 2009;193(2):425-430.
Patient Participation in Medication Reconciliation at Discharge Helps Detect Prescribing Discrepancies
Clinical question: Does the inclusion of a medication adherence counseling session during a hospital discharge reconciliation process reduce discrepancies in the final medication regimen?
Background: Inadvertent medication prescribing errors are an important cause of preventable adverse drug events and commonly occur at transitions of care. Although medication reconciliation processes can identify errors, the best strategies for implementation remain unclear.
Study design: Prospective, observational cohort.
Setting: A 550-bed teaching hospital in the Netherlands.
Synopsis: Of 437 patients admitted to a pulmonary ward and screened for eligibility, 267 were included in the analysis. A pharmacy specialist reviewed all available community prescription records, inpatient documentation, and discharge medication lists in an effort to identify discrepancies. Potential errors were discussed with the prescriber. Then, the pharmacy specialist interviewed the patient and provided additional counseling. Any new discrepancies were discussed with the prescriber. All questions raised by the pharmacist were recorded, as were all subsequent prescriber interventions.
The primary outcome measure was the number of interventions made as a result of pharmacy review. A total of 940 questions were asked. At least one intervention was recorded for 87% of patients before counseling (mean 2.7 interventions/patient) and for 97% of patients after (mean 5.3 interventions/patient). Discrepancies were addressed for 63.7% of patients before counseling and 72.5% after. Pharmacotherapy was optimized for 67.2% of patients before counseling and 76.3% after.
Bottom line: Patient engagement in the medication reconciliation process incrementally improves the quality of the history and helps identify clinically meaningful discrepancies at the time of hospital discharge.
Citation: Karapinar-Carkit F, Borgsteede S, Zoer J, Smit HJ, Egberts AC, van den Bemt P. Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009;43(6):1001-1010.
Computer-Based Reminders Have Small to Modest Effect on Care Processes
Clinical question: Do on-screen, computer-based clinical reminders improve adherence to target processes of care or clinical outcomes?
Background: Gaps between practice guidelines and routine care are caused, in part, by the inability of clinicians to access or recall information at the point of care. Although automated reminder systems offer the promise of “just in time” recommendations, studies of electronic reminders have demonstrated mixed results.
Study design: Literature review and meta-analysis.
Setting: Multiple databases and information repositories, including MEDLINE, EMBASE, and CINAHL.
Synopsis: The authors conducted a literature search to identify randomized and quasi-randomized controlled trials measuring the effect of computer-based reminders on process measures or clinical outcomes. To avoid statistical challenges inherent in unit-of-analysis errors, the authors reported median improvement in process adherence or median change in clinical endpoints.
Out of a pool of 2,036 citations, 28 studies detailing 32 comparative analyses were included. Across the 28 studies, reminders resulted in a median improvement in target process adherence of 4.2% (3.3% for prescribing behavior, 2.8% for test ordering). Eight comparisons reported dichotomous clinical endpoints and collectively showed a median absolute improvement of 2.5%.
The greatest contribution to measured treatment effects came from large academic centers with well-established electronic health records and robust informatics departments. No characteristics of the reminder system or the clinical context were associated with the magnitude of impact. A potential limitation in reporting median effects across studies is that all studies were given equal weight.
Bottom line: Electronic reminders appear to have a small, positive effect on clinician adherence to recommended processes, although it is uncertain what contextual or design features are responsible for the greatest treatment effect.
Citation: Shojania K, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009(3):CD001096. TH
Pediatric HM Literature
Short Course of Oral Antibiotics Effective for Acute Osteomyelitis and Septic Arthritis in Children
By Mark Shen, MD
Clinical question: Is a short course (less than four weeks) of antibiotics effective for the treatment of acute osteomyelitis and septic arthritis?
Background: The optimal duration of treatment for acute bone and joint infections in children has not been assessed adequately in prospectively designed trials. Historically, intravenous (IV) antibiotics in four- to six-week durations have been recommended, although the evidence for this practice is limited. There is widespread variation in both the route of administration (oral vs. IV) and duration of this treatment.
Study design: Prospective cohort study.
Setting: Two children’s hospitals in Australia.
Synopsis: Seventy children ages 17 and under who presented to two tertiary-care children’s hospitals with osteomyelitis or septic arthritis were enrolled. Primary surgical drainage was performed for patients with septic arthritis. Intravenous antibiotics were administered for at least three days, and until clinical symptoms improved and the C-reactive protein levels had stabilized. Patients then were transitioned to oral antibiotics and discharged to complete a minimum of three weeks of therapy.
Fifty-nine percent of patients were converted to oral antibiotics by day three, 86% by day five of therapy. Based on clinical and hematologic assessment, 83% of patients had oral antibiotics stopped at the three-week followup and remained well through the 12-month follow-up period.
This study essentially involved prospective data collection for a cohort of children receiving standardized care. Although the results suggest that a majority of children can be treated with a three-week course of oral antibiotics, the results would have been further strengthened by an explicit protocol with well-defined criteria for the oral to IV transition and cessation of antibiotic therapy. Additional limitations include pathogens and antibiotic choices that might not be applicable to North American populations.
Bottom line: After initial intravenous therapy, a three-week course of oral antibiotics can be effective for acute osteomyelitis and septic arthritis in children.
Citation: Jagodzinski NA, Kanwar R, Graham K, Bache CE. Prospective evaluation of a shortened regimen of treatment for acute osteomyelitis and septic arthritis in children. J Pediatr Orthop. 2009;29(5):518-525.
In the Literature
Literature at a Glance
A guide to this month’s studies.
- Physiologic doses of corticosteroids provide no clear benefit to patients with septic shock.
- Endovascular vs. open repair of abdominal aortic aneurysms is associated with fewer short-term deaths but complications and higher late reinterventions.
- Neither intensive insulin nor use of colloid over crystalloid improves mortality or organ failure outcomes in sepsis.
- Surgical cure for diabetes shows promise at two-year follow-up.
- Delayed defibrillation negatively affects survival.
- Right-ventricular enlargement in patients with acute PE is not associated with increased mortality.
- Periprocedural interruption of warfarin therapy presents low risk of thromboembolism.
- Minor leg injury increases risk of developing venous thrombosis threefold.
- Oral vs. parenteral antibiotics for pediatric pyelonephritis.
Do Physiologic Doses of Hydrocortisone Benefit Patients With Septic Shock?
Background: Meta-analyses and guidelines advocate the use of physiologic dose steroids in patients exhibiting septic shock. However, recommendations are largely based on the results of a single trial where benefits were seen only in patients without a response to corticotropin.
Study design: Multicenter, randomized, double-blind, placebo-controlled study.
Setting: Fifty-two participating ICUs in nine countries.
Synopsis: A total of 499 patients with evidence of infection or a systemic inflammatory response characterized by refractory hypotension were randomly selected to receive either an 11-day tapering dose of hydrocortisone or a placebo. The primary outcome was death from any cause at 28 days. A corticotropin stimulation test was conducted on every patient to assess adrenal function. There were no differences in death rates or duration of hospitalization between study arms. Overall, there were 86 deaths in the hydrocortisone group and 78 deaths in the placebo group (p=0.51). Also, response to corticotropin appeared to have little bearing on outcomes.
The study was underpowered due to low enrollment and a lower-than-expected death rate. Nevertheless, this is the largest trial to date examining the role of steroids in the management of septic shock and calls into question the strength of prior data and published guidelines.
Bottom line: This study failed to demonstrate a clinically or statistically significant treatment effect from the administration of physiologic-dose steroids in patients with septic shock.
Citation: Sprung C, Annane D, Keh D, et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008;358(2):111-124.
Does Open or Endovascular Repair of Abdominal Aortic Aneurysm Benefit the Medicare Population?
Background: Randomized controlled trials (RCT) have shown a perioperative survival benefit of endovascular repair over open repair with fewer complications and shorter recovery. There is concern that late morbidity may be increased with endovascular repair. Patients enrolled in the trials were highly selected at specialty centers, so the results may not reflect actual practice.
Study design: Retrospective, propensity-matched, observational cohort study.
Synopsis: 22,830 patients were matched in each cohort. Patients were eligible if they had an abdominal aortic aneurysm repair without rupture and excluded if they were enrolled in health maintenance organizations.
Outcomes included death within 30 days and late survival, perioperative complications, aneurysm rupture, reintervention, and laparotomy-related complications. The average age was 76, and 20% were women. Perioperative mortality was lower after endovascular repair (1.2% vs. 4.8%, p<0.001), and older patients had a greater benefit. Late survival was similar. By four years, rupture was more likely in the endovascular group (1.8% vs. 0.5%, p<0.001), as was reintervention (9% vs. 1.7%, p<0.001).
In contrast, by four years, surgery for laparotomy-related complications was more likely in the open-repair group (9.7% v 4.1%, p<0.001), as was hospitalization for bowel obstruction or abdominal-wall hernia (14.2% v 8.1%, p<0.001). Limitations included the non-randomized design and use of administrative data for important categorical variables including medical co-morbidities.
Bottom line: As compared with open repair, endovascular repair of abdominal aortic aneurysm is associated with lower short-term death and complications and higher late reinterventions. This is balanced by an increase in laparotomy-related reinterventions after open repair.
Citation: Schermerhorn ML, O’Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N Engl J Med. 2008 Jan 31;358(5):464-474.
What Therapy Improves Outcomes in ICU Patients With Severe Sepsis or Septic Shock?
Background: Evidence suggests lower mortality with intensive insulin therapy in post-surgical cardiac patients. There is no proven benefit for non-surgical ICU patients. Despite lack of data, intensive insulin in severe sepsis has been widely advocated. Little is known to guide the use of colloid or crystalloid for fluid resuscitation in sepsis.
Study design: Multicenter, two-by-two factorial, open-label trial.
Setting: Multidisciplinary ICUs at 18 academic tertiary hospitals in Germany.
Synopsis: Data were analyzed for 537 patients with severe sepsis. They were randomly selected to receive intensive insulin therapy (n=247) or conventional insulin therapy (290), with either 10% hydroxyethyl starch (HES) (262) or modified Ringer’s lactate (LR) (275) for fluid resuscitation.
Co-primary endpoints were all-cause mortality at 28 days and morbidity as measured by the mean score on the Sequential Organ Failure Assessment (SOFA). The trial was stopped early for safety reasons. Intensive insulin therapy was terminated due to an increased number of hypoglycemic events in the intensive-therapy group compared with conventional therapy (12.1% vs. 2.1%, p<0.001), and there was no difference in mortality between groups at 28 and 90 days.
Interim analysis of 600 patients showed patients given HES had higher incidence of renal failure compared with LR (34.9% vs. 22.8%, p=0.002), required more days of renal replacement therapy, had lower median platelets and received more units of packed red cells. There was a trend toward higher rate of death at 90 days in those treated with HES (41% vs. 33.9%, p=0.09).
Bottom line: Intensive insulin therapy in ICU patients with severe sepsis and septic shock does not improve mortality and increases hypoglycemia and ICU length of stay. Use of colloid over crystalloid should be avoided, showing a trend toward increased death at 90 days, higher rates of acute renal failure, and need for renal replacement therapy..
Citation: Brunkhorst FM, Engel C, Bloos F, et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008;358(2):125-139.
How Does Laparoscopic Adjustable Gastric Banding Affect Obese Adults With Type 2 Diabetes?
Background: Observational studies related surgical weight loss to improved glycemic control, but clinical trials did not test this relationship. The current trial examined this hypothesis.
Study design: Unmasked, randomized controlled trial.
Setting: University Obesity Research Center, Australia.
Synopsis: Sixty adults age 20-60 with body-mass index (BMI) of 30-40 and diagnosed with diabetes mellitus type 2 (DM2) within two years of recruitment were randomized into conventional therapy and surgical groups.
While both groups were treated similarly, only the surgical group received laparoscopic adjustable gastric banding. Primary outcome was remission of DM2 (a fasting glucose less than 126 mg/dl, HbA1C less than 6.2%, and off all hypoglycemic agents). At two years, 73% in the surgical group compared with 13% in the conventional group attained this outcome (relative risk [RR] 5.5, 95% confidence interval [CI] 2.2-14.0; p<0.001). Compared with the conventional group, the surgical group demonstrated statistically significant improvements in several secondary outcomes including mean body weight, waist circumference, insulin resistance, and lipids.
The limitations of the study are that it examined a small number of patients with shorter duration of DM2 and a shorter follow-up. The lower surgical complication rates cannot be generalized to other centers.
Bottom line: This study is a step forward in examining the relationship of surgical weight loss and remission of DM2. However, large multicenter trials with longer periods of follow-up in diverse group of patients would result in a better understanding of this relationship.
Citation: Dixon JB, O’Brien PE, Playfair J, et. al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008;299(3):316-323.
What is the Prevalence of Delayed Defibrillation and its Association With Survival to Discharge?
Background: Despite advances in resuscitation, survival rates following cardiac arrest remain low. Previous studies observed the effect of the timing of defibrillation on survival. This study examined the magnitude of delayed defibrillation and its association with survival in adults who sustained cardiac arrest specifically from ventricular fibrillation and pulseless ventricular tachycardia.
Study design: National Registry of Cardiopulmonary Resuscitation (NRCPR), a multicenter prospective cohort.
Setting: 369 U.S. hospitals providing acute care.
Synopsis: Data from NRCPR relating to 6,789 cardiac arrests secondary to ventricular fibrillation or pulseless ventricular tachycardia, at 369 hospitals in hospitalized adults were analyzed. Delayed defibrillation was defined as occurring more than two minutes from the identification of ventricular fibrillation or pulseless ventricular tachycardia to the administration of the first shock to the patient.
Delayed defibrillation occurred in 2,045 (30.1%) subjects. A lower proportion of subjects who received delayed defibrillation (22.2%) compared with those who received defibrillation in two minutes or less (39.3%) survived to hospital discharge. This was statistically significant (adjusted odds ratio [OR] 0.48, 95% CI 0.42 to 0.54; p<0.01).
Bottom line: This study not only reported that delayed defibrillation was prevalent in adult hospitalized patients, but also reinforced the importance of defibrillation within two minutes of identification of cardiac arrest secondary to ventricular fibrillation and pulseless ventricular tachycardia for better survival outcomes.
Citation: Chan PS, Krumholz HM, Nichol G, Nallamothu BK. Delayed time to defibrillation after in-hospital cardiac arrest. N Engl J Med. 2008;358(1):9-17.
Does Right-Ventricle Enlargement in Acute PE Increase In-hospital Death From PE or All-cause Mortality?
Background: Previous studies have shown conflicting results regarding the risk of death with right-ventricular enlargement in acute pulmonary embolism (PE). The role of thrombolysis in hemodynamically stable patients with acute PE and right-ventricular enlargement remains controversial.
Study design: Retrospective analysis of prospective cohort study.
Setting: Academic centers housing inpatients and outpatients in the United States and Canada.
Synopsis: Patients enrolled in PIOPED II who were diagnosed with acute PE and had multidetector computed tomographic (CT) angiography were retrospectively reviewed for the presence of right-ventricular enlargement. Study determined that 181 patients had PE and a CT, and 157 were adequate for measurement of right-ventricular size. PE treatment was anticoagulation in 138, anticoagulation and inferior vena cava filter in 15, inferior vena cava filter alone in two, and thrombolysis in two.
Right-ventricular enlargement was found in 78 (50%) patients; 76 were treated with anticoagulation alone or in combination with inferior vena cava filter. For patients with and without right-ventricular enlargement, there was no difference in in-hospital death from PE (0% vs. 1.3%) or all-cause mortality (2.6% vs. 2.5%). The results were unchanged when examined for septal motion abnormality and previous cardiopulmonary disease.
Bottom line: In hemodynamically stable patients with acute pulmonary embolism, right ventricular enlargement does not increase mortality. Further, thrombolytic therapy is unlikely to improve outcomes.
Citation: Stein PD, Beemath A, Matti F, et al. Enlarged right ventricle without shock in acute pulmonary embolus: prognosis. Am J Med. 2008;121:34-42.
What Are Short-term Thromboembolism, Hemorrhage Risks When Interrupting Warfarin Therapy for Procedures?
Background: The risks of thromboembolism and hemorrhage during the periprocedural interruption of warfarin therapy are not known. The risks and benefits of heparin bridging therapy are not well described.
Study design: Multicenter, prospective, observational cohort study.
Setting: Community-based physician practices.
Synopsis: Patients were eligible if they were on long-term warfarin and underwent outpatient procedures requiring interruption of therapy. The primary outcomes were thromboembolism or hemorrhage within 30 days of therapy interruption. In all, 1,024 eligible patients (7.1% considered high risk) had 1,293 interruptions of warfarin therapy. The most common procedures were colonoscopy (25.1%), oral or dental surgery (24.9%), and ophthalmologic surgery (8.9%). Warfarin interruption was five or fewer days in 83.8% of episodes.
Thromboembolism occurred in seven (0.7%) patients, and major or clinically significant bleeding occurred in 23 (0.6%, and 1.7%, respectively) patients. Periprocedural bridging with heparin was used in 88 (8.6%) patients. Of the patients who received periprocedural heparin therapy, none had thromboembolism, and 14 (13%) had bleeding episodes.
Bottom line: In patients whose warfarin therapy is interrupted to undergo outpatient procedures, the risk of thromboembolism is low and the hemorrhagic risk of heparin bridging therapy is significant.
Citation: Garcia DA, Regan S, Henault LE, et al. Risk of thromboembolism with short-term interruption of warfarin therapy. Arch Intern Med. 2008;168(1):63-69.
Are Minor Injuries an Independent Risk Factor For Development of DVT?
Background: Prior studies focus on major injuries as a risk factor for deep-vein thrombosis (DVT) and PE. However, major injury is often associated with other risks for venous thrombosis, such as surgery, plaster casting, hospitalization, and extended bed rest. Risk of DVT with minor injuries that don’t lead to these factors is unknown.
Study design: Large population-based case-control study.
Setting: Six anticoagulation clinics in the Netherlands.
Synopsis: 2,471 consecutive cases (patients with first episode of DVT or PE) and 3,534 controls (partners of cases or random digit dialing contacts) were enrolled. Participants were mailed a questionnaire, including a list of eight common injuries.
Participants with history of cast, surgery, recent hospitalization, extended bed rest, or prior history of cancer were excluded. A subset of patients and controls underwent DNA and blood collection to evaluate for presence of a hypercoagulable state. Of the cases, 289 (11.7%) had a minor injury within three months of the index date, compared with 154 (4.4%) of controls, representing a threefold increased risk of DVT/PE with minor injury (OR 3.1). Partial ruptures of muscles or ligaments in the leg (OR 10.9), multiple simultaneous injuries (OR 9.9), and injury within four weeks of presentation (OR 4.0), were associated with increased risk of DVT/PE.
Patients found to be Factor V Leiden carriers with injury had an almost 50-fold increased risk of venous thromboembolism (VTE) compared with non-carriers without injury (OR 49.7). Authors appropriately address possible limitations, including recall and referral bias.
Bottom line: Minor leg injury is associated with threefold risk of DVT/PE, especially in the four weeks following injury. Providers should consider short-term prophylactic treatment in patients with Factor V Leiden or high-risk injuries.
Citation: Van Stralen KJ, Rosendaal FR, Doggen CJ. Minor injuries as a risk factor for venous thrombosis. Arch Intern Med. 2008;168(1):21-26.
Is Oral Amox-Clav Non-inferior to IV Antibiotics in Pediatric Pyelonephritis?
Background: Present guidelines recommend initial treatment for pediatric pyelonephritis to be a parenteral third-generation cephalosporin followed by oral antibiotics. One prior randomly selected controlled trial compared oral antibiotics only with antibiotics started parenterally, but there was a higher-than-usual incidence of vesicoureteral reflux and female gender in the study.
Study design: Non-inferiority, multicenter, random, open label, controlled trial.
Setting: Twenty-eight pediatric units in northeast Italy from 2000-2005
Synopsis: 502 children age 1 month to less than 7 years with a clinical diagnosis of first occurrence of acute pyelonephritis according to urinalysis and urine culture (requiring two concordant consecutive tests) with at least two of the following conditions: fever of 38 degrees C or more or elevated erythrocyte sedimentation rate (ESR) or c-reactive protein (CRP), and elevated neutrophil count were randomized to receive oral amoxicillin-clavulanate (AC) or parenteral ceftriaxone followed by oral AC. Exclusion criteria were sepsis, dehydration, vomiting, and creatinine clearance of 70 ml/min or less.
Also, 400 children had dimercaptosuccinic acid (DMSA) scintigraphy within 10 days of study entry. Meantime, 223 had repeat DMSA at one year, and 177 had normal scans at study entry so were not repeated. At one year, 20% of patients were lost to follow-up. The primary outcome was renal scarring at one year. Secondary outcomes included time to fever defervescence, reduction in inflammatory indices, and percentage with sterile urine after 72 hours. Intention to treat analysis showed no significant differences between oral (n=244) and parenteral (n=258) treatment, both in the primary outcome 13.7% vs. 17.7% (95% CI, -11.1% to 3.1%), and secondary outcomes.
Bottom line: Treatment with oral antibiotics is as effective as parenteral then oral treatment for first episode of acute pediatric pyelonephritis.
Citation: Montini G, Toffolo A, Zucchetta P, et al. Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial. BMJ. 2007 Aug 25;335(7616):386.
Literature at a Glance
A guide to this month’s studies.
- Physiologic doses of corticosteroids provide no clear benefit to patients with septic shock.
- Endovascular vs. open repair of abdominal aortic aneurysms is associated with fewer short-term deaths but complications and higher late reinterventions.
- Neither intensive insulin nor use of colloid over crystalloid improves mortality or organ failure outcomes in sepsis.
- Surgical cure for diabetes shows promise at two-year follow-up.
- Delayed defibrillation negatively affects survival.
- Right-ventricular enlargement in patients with acute PE is not associated with increased mortality.
- Periprocedural interruption of warfarin therapy presents low risk of thromboembolism.
- Minor leg injury increases risk of developing venous thrombosis threefold.
- Oral vs. parenteral antibiotics for pediatric pyelonephritis.
Do Physiologic Doses of Hydrocortisone Benefit Patients With Septic Shock?
Background: Meta-analyses and guidelines advocate the use of physiologic dose steroids in patients exhibiting septic shock. However, recommendations are largely based on the results of a single trial where benefits were seen only in patients without a response to corticotropin.
Study design: Multicenter, randomized, double-blind, placebo-controlled study.
Setting: Fifty-two participating ICUs in nine countries.
Synopsis: A total of 499 patients with evidence of infection or a systemic inflammatory response characterized by refractory hypotension were randomly selected to receive either an 11-day tapering dose of hydrocortisone or a placebo. The primary outcome was death from any cause at 28 days. A corticotropin stimulation test was conducted on every patient to assess adrenal function. There were no differences in death rates or duration of hospitalization between study arms. Overall, there were 86 deaths in the hydrocortisone group and 78 deaths in the placebo group (p=0.51). Also, response to corticotropin appeared to have little bearing on outcomes.
The study was underpowered due to low enrollment and a lower-than-expected death rate. Nevertheless, this is the largest trial to date examining the role of steroids in the management of septic shock and calls into question the strength of prior data and published guidelines.
Bottom line: This study failed to demonstrate a clinically or statistically significant treatment effect from the administration of physiologic-dose steroids in patients with septic shock.
Citation: Sprung C, Annane D, Keh D, et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008;358(2):111-124.
Does Open or Endovascular Repair of Abdominal Aortic Aneurysm Benefit the Medicare Population?
Background: Randomized controlled trials (RCT) have shown a perioperative survival benefit of endovascular repair over open repair with fewer complications and shorter recovery. There is concern that late morbidity may be increased with endovascular repair. Patients enrolled in the trials were highly selected at specialty centers, so the results may not reflect actual practice.
Study design: Retrospective, propensity-matched, observational cohort study.
Synopsis: 22,830 patients were matched in each cohort. Patients were eligible if they had an abdominal aortic aneurysm repair without rupture and excluded if they were enrolled in health maintenance organizations.
Outcomes included death within 30 days and late survival, perioperative complications, aneurysm rupture, reintervention, and laparotomy-related complications. The average age was 76, and 20% were women. Perioperative mortality was lower after endovascular repair (1.2% vs. 4.8%, p<0.001), and older patients had a greater benefit. Late survival was similar. By four years, rupture was more likely in the endovascular group (1.8% vs. 0.5%, p<0.001), as was reintervention (9% vs. 1.7%, p<0.001).
In contrast, by four years, surgery for laparotomy-related complications was more likely in the open-repair group (9.7% v 4.1%, p<0.001), as was hospitalization for bowel obstruction or abdominal-wall hernia (14.2% v 8.1%, p<0.001). Limitations included the non-randomized design and use of administrative data for important categorical variables including medical co-morbidities.
Bottom line: As compared with open repair, endovascular repair of abdominal aortic aneurysm is associated with lower short-term death and complications and higher late reinterventions. This is balanced by an increase in laparotomy-related reinterventions after open repair.
Citation: Schermerhorn ML, O’Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N Engl J Med. 2008 Jan 31;358(5):464-474.
What Therapy Improves Outcomes in ICU Patients With Severe Sepsis or Septic Shock?
Background: Evidence suggests lower mortality with intensive insulin therapy in post-surgical cardiac patients. There is no proven benefit for non-surgical ICU patients. Despite lack of data, intensive insulin in severe sepsis has been widely advocated. Little is known to guide the use of colloid or crystalloid for fluid resuscitation in sepsis.
Study design: Multicenter, two-by-two factorial, open-label trial.
Setting: Multidisciplinary ICUs at 18 academic tertiary hospitals in Germany.
Synopsis: Data were analyzed for 537 patients with severe sepsis. They were randomly selected to receive intensive insulin therapy (n=247) or conventional insulin therapy (290), with either 10% hydroxyethyl starch (HES) (262) or modified Ringer’s lactate (LR) (275) for fluid resuscitation.
Co-primary endpoints were all-cause mortality at 28 days and morbidity as measured by the mean score on the Sequential Organ Failure Assessment (SOFA). The trial was stopped early for safety reasons. Intensive insulin therapy was terminated due to an increased number of hypoglycemic events in the intensive-therapy group compared with conventional therapy (12.1% vs. 2.1%, p<0.001), and there was no difference in mortality between groups at 28 and 90 days.
Interim analysis of 600 patients showed patients given HES had higher incidence of renal failure compared with LR (34.9% vs. 22.8%, p=0.002), required more days of renal replacement therapy, had lower median platelets and received more units of packed red cells. There was a trend toward higher rate of death at 90 days in those treated with HES (41% vs. 33.9%, p=0.09).
Bottom line: Intensive insulin therapy in ICU patients with severe sepsis and septic shock does not improve mortality and increases hypoglycemia and ICU length of stay. Use of colloid over crystalloid should be avoided, showing a trend toward increased death at 90 days, higher rates of acute renal failure, and need for renal replacement therapy..
Citation: Brunkhorst FM, Engel C, Bloos F, et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008;358(2):125-139.
How Does Laparoscopic Adjustable Gastric Banding Affect Obese Adults With Type 2 Diabetes?
Background: Observational studies related surgical weight loss to improved glycemic control, but clinical trials did not test this relationship. The current trial examined this hypothesis.
Study design: Unmasked, randomized controlled trial.
Setting: University Obesity Research Center, Australia.
Synopsis: Sixty adults age 20-60 with body-mass index (BMI) of 30-40 and diagnosed with diabetes mellitus type 2 (DM2) within two years of recruitment were randomized into conventional therapy and surgical groups.
While both groups were treated similarly, only the surgical group received laparoscopic adjustable gastric banding. Primary outcome was remission of DM2 (a fasting glucose less than 126 mg/dl, HbA1C less than 6.2%, and off all hypoglycemic agents). At two years, 73% in the surgical group compared with 13% in the conventional group attained this outcome (relative risk [RR] 5.5, 95% confidence interval [CI] 2.2-14.0; p<0.001). Compared with the conventional group, the surgical group demonstrated statistically significant improvements in several secondary outcomes including mean body weight, waist circumference, insulin resistance, and lipids.
The limitations of the study are that it examined a small number of patients with shorter duration of DM2 and a shorter follow-up. The lower surgical complication rates cannot be generalized to other centers.
Bottom line: This study is a step forward in examining the relationship of surgical weight loss and remission of DM2. However, large multicenter trials with longer periods of follow-up in diverse group of patients would result in a better understanding of this relationship.
Citation: Dixon JB, O’Brien PE, Playfair J, et. al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008;299(3):316-323.
What is the Prevalence of Delayed Defibrillation and its Association With Survival to Discharge?
Background: Despite advances in resuscitation, survival rates following cardiac arrest remain low. Previous studies observed the effect of the timing of defibrillation on survival. This study examined the magnitude of delayed defibrillation and its association with survival in adults who sustained cardiac arrest specifically from ventricular fibrillation and pulseless ventricular tachycardia.
Study design: National Registry of Cardiopulmonary Resuscitation (NRCPR), a multicenter prospective cohort.
Setting: 369 U.S. hospitals providing acute care.
Synopsis: Data from NRCPR relating to 6,789 cardiac arrests secondary to ventricular fibrillation or pulseless ventricular tachycardia, at 369 hospitals in hospitalized adults were analyzed. Delayed defibrillation was defined as occurring more than two minutes from the identification of ventricular fibrillation or pulseless ventricular tachycardia to the administration of the first shock to the patient.
Delayed defibrillation occurred in 2,045 (30.1%) subjects. A lower proportion of subjects who received delayed defibrillation (22.2%) compared with those who received defibrillation in two minutes or less (39.3%) survived to hospital discharge. This was statistically significant (adjusted odds ratio [OR] 0.48, 95% CI 0.42 to 0.54; p<0.01).
Bottom line: This study not only reported that delayed defibrillation was prevalent in adult hospitalized patients, but also reinforced the importance of defibrillation within two minutes of identification of cardiac arrest secondary to ventricular fibrillation and pulseless ventricular tachycardia for better survival outcomes.
Citation: Chan PS, Krumholz HM, Nichol G, Nallamothu BK. Delayed time to defibrillation after in-hospital cardiac arrest. N Engl J Med. 2008;358(1):9-17.
Does Right-Ventricle Enlargement in Acute PE Increase In-hospital Death From PE or All-cause Mortality?
Background: Previous studies have shown conflicting results regarding the risk of death with right-ventricular enlargement in acute pulmonary embolism (PE). The role of thrombolysis in hemodynamically stable patients with acute PE and right-ventricular enlargement remains controversial.
Study design: Retrospective analysis of prospective cohort study.
Setting: Academic centers housing inpatients and outpatients in the United States and Canada.
Synopsis: Patients enrolled in PIOPED II who were diagnosed with acute PE and had multidetector computed tomographic (CT) angiography were retrospectively reviewed for the presence of right-ventricular enlargement. Study determined that 181 patients had PE and a CT, and 157 were adequate for measurement of right-ventricular size. PE treatment was anticoagulation in 138, anticoagulation and inferior vena cava filter in 15, inferior vena cava filter alone in two, and thrombolysis in two.
Right-ventricular enlargement was found in 78 (50%) patients; 76 were treated with anticoagulation alone or in combination with inferior vena cava filter. For patients with and without right-ventricular enlargement, there was no difference in in-hospital death from PE (0% vs. 1.3%) or all-cause mortality (2.6% vs. 2.5%). The results were unchanged when examined for septal motion abnormality and previous cardiopulmonary disease.
Bottom line: In hemodynamically stable patients with acute pulmonary embolism, right ventricular enlargement does not increase mortality. Further, thrombolytic therapy is unlikely to improve outcomes.
Citation: Stein PD, Beemath A, Matti F, et al. Enlarged right ventricle without shock in acute pulmonary embolus: prognosis. Am J Med. 2008;121:34-42.
What Are Short-term Thromboembolism, Hemorrhage Risks When Interrupting Warfarin Therapy for Procedures?
Background: The risks of thromboembolism and hemorrhage during the periprocedural interruption of warfarin therapy are not known. The risks and benefits of heparin bridging therapy are not well described.
Study design: Multicenter, prospective, observational cohort study.
Setting: Community-based physician practices.
Synopsis: Patients were eligible if they were on long-term warfarin and underwent outpatient procedures requiring interruption of therapy. The primary outcomes were thromboembolism or hemorrhage within 30 days of therapy interruption. In all, 1,024 eligible patients (7.1% considered high risk) had 1,293 interruptions of warfarin therapy. The most common procedures were colonoscopy (25.1%), oral or dental surgery (24.9%), and ophthalmologic surgery (8.9%). Warfarin interruption was five or fewer days in 83.8% of episodes.
Thromboembolism occurred in seven (0.7%) patients, and major or clinically significant bleeding occurred in 23 (0.6%, and 1.7%, respectively) patients. Periprocedural bridging with heparin was used in 88 (8.6%) patients. Of the patients who received periprocedural heparin therapy, none had thromboembolism, and 14 (13%) had bleeding episodes.
Bottom line: In patients whose warfarin therapy is interrupted to undergo outpatient procedures, the risk of thromboembolism is low and the hemorrhagic risk of heparin bridging therapy is significant.
Citation: Garcia DA, Regan S, Henault LE, et al. Risk of thromboembolism with short-term interruption of warfarin therapy. Arch Intern Med. 2008;168(1):63-69.
Are Minor Injuries an Independent Risk Factor For Development of DVT?
Background: Prior studies focus on major injuries as a risk factor for deep-vein thrombosis (DVT) and PE. However, major injury is often associated with other risks for venous thrombosis, such as surgery, plaster casting, hospitalization, and extended bed rest. Risk of DVT with minor injuries that don’t lead to these factors is unknown.
Study design: Large population-based case-control study.
Setting: Six anticoagulation clinics in the Netherlands.
Synopsis: 2,471 consecutive cases (patients with first episode of DVT or PE) and 3,534 controls (partners of cases or random digit dialing contacts) were enrolled. Participants were mailed a questionnaire, including a list of eight common injuries.
Participants with history of cast, surgery, recent hospitalization, extended bed rest, or prior history of cancer were excluded. A subset of patients and controls underwent DNA and blood collection to evaluate for presence of a hypercoagulable state. Of the cases, 289 (11.7%) had a minor injury within three months of the index date, compared with 154 (4.4%) of controls, representing a threefold increased risk of DVT/PE with minor injury (OR 3.1). Partial ruptures of muscles or ligaments in the leg (OR 10.9), multiple simultaneous injuries (OR 9.9), and injury within four weeks of presentation (OR 4.0), were associated with increased risk of DVT/PE.
Patients found to be Factor V Leiden carriers with injury had an almost 50-fold increased risk of venous thromboembolism (VTE) compared with non-carriers without injury (OR 49.7). Authors appropriately address possible limitations, including recall and referral bias.
Bottom line: Minor leg injury is associated with threefold risk of DVT/PE, especially in the four weeks following injury. Providers should consider short-term prophylactic treatment in patients with Factor V Leiden or high-risk injuries.
Citation: Van Stralen KJ, Rosendaal FR, Doggen CJ. Minor injuries as a risk factor for venous thrombosis. Arch Intern Med. 2008;168(1):21-26.
Is Oral Amox-Clav Non-inferior to IV Antibiotics in Pediatric Pyelonephritis?
Background: Present guidelines recommend initial treatment for pediatric pyelonephritis to be a parenteral third-generation cephalosporin followed by oral antibiotics. One prior randomly selected controlled trial compared oral antibiotics only with antibiotics started parenterally, but there was a higher-than-usual incidence of vesicoureteral reflux and female gender in the study.
Study design: Non-inferiority, multicenter, random, open label, controlled trial.
Setting: Twenty-eight pediatric units in northeast Italy from 2000-2005
Synopsis: 502 children age 1 month to less than 7 years with a clinical diagnosis of first occurrence of acute pyelonephritis according to urinalysis and urine culture (requiring two concordant consecutive tests) with at least two of the following conditions: fever of 38 degrees C or more or elevated erythrocyte sedimentation rate (ESR) or c-reactive protein (CRP), and elevated neutrophil count were randomized to receive oral amoxicillin-clavulanate (AC) or parenteral ceftriaxone followed by oral AC. Exclusion criteria were sepsis, dehydration, vomiting, and creatinine clearance of 70 ml/min or less.
Also, 400 children had dimercaptosuccinic acid (DMSA) scintigraphy within 10 days of study entry. Meantime, 223 had repeat DMSA at one year, and 177 had normal scans at study entry so were not repeated. At one year, 20% of patients were lost to follow-up. The primary outcome was renal scarring at one year. Secondary outcomes included time to fever defervescence, reduction in inflammatory indices, and percentage with sterile urine after 72 hours. Intention to treat analysis showed no significant differences between oral (n=244) and parenteral (n=258) treatment, both in the primary outcome 13.7% vs. 17.7% (95% CI, -11.1% to 3.1%), and secondary outcomes.
Bottom line: Treatment with oral antibiotics is as effective as parenteral then oral treatment for first episode of acute pediatric pyelonephritis.
Citation: Montini G, Toffolo A, Zucchetta P, et al. Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial. BMJ. 2007 Aug 25;335(7616):386.
Literature at a Glance
A guide to this month’s studies.
- Physiologic doses of corticosteroids provide no clear benefit to patients with septic shock.
- Endovascular vs. open repair of abdominal aortic aneurysms is associated with fewer short-term deaths but complications and higher late reinterventions.
- Neither intensive insulin nor use of colloid over crystalloid improves mortality or organ failure outcomes in sepsis.
- Surgical cure for diabetes shows promise at two-year follow-up.
- Delayed defibrillation negatively affects survival.
- Right-ventricular enlargement in patients with acute PE is not associated with increased mortality.
- Periprocedural interruption of warfarin therapy presents low risk of thromboembolism.
- Minor leg injury increases risk of developing venous thrombosis threefold.
- Oral vs. parenteral antibiotics for pediatric pyelonephritis.
Do Physiologic Doses of Hydrocortisone Benefit Patients With Septic Shock?
Background: Meta-analyses and guidelines advocate the use of physiologic dose steroids in patients exhibiting septic shock. However, recommendations are largely based on the results of a single trial where benefits were seen only in patients without a response to corticotropin.
Study design: Multicenter, randomized, double-blind, placebo-controlled study.
Setting: Fifty-two participating ICUs in nine countries.
Synopsis: A total of 499 patients with evidence of infection or a systemic inflammatory response characterized by refractory hypotension were randomly selected to receive either an 11-day tapering dose of hydrocortisone or a placebo. The primary outcome was death from any cause at 28 days. A corticotropin stimulation test was conducted on every patient to assess adrenal function. There were no differences in death rates or duration of hospitalization between study arms. Overall, there were 86 deaths in the hydrocortisone group and 78 deaths in the placebo group (p=0.51). Also, response to corticotropin appeared to have little bearing on outcomes.
The study was underpowered due to low enrollment and a lower-than-expected death rate. Nevertheless, this is the largest trial to date examining the role of steroids in the management of septic shock and calls into question the strength of prior data and published guidelines.
Bottom line: This study failed to demonstrate a clinically or statistically significant treatment effect from the administration of physiologic-dose steroids in patients with septic shock.
Citation: Sprung C, Annane D, Keh D, et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008;358(2):111-124.
Does Open or Endovascular Repair of Abdominal Aortic Aneurysm Benefit the Medicare Population?
Background: Randomized controlled trials (RCT) have shown a perioperative survival benefit of endovascular repair over open repair with fewer complications and shorter recovery. There is concern that late morbidity may be increased with endovascular repair. Patients enrolled in the trials were highly selected at specialty centers, so the results may not reflect actual practice.
Study design: Retrospective, propensity-matched, observational cohort study.
Synopsis: 22,830 patients were matched in each cohort. Patients were eligible if they had an abdominal aortic aneurysm repair without rupture and excluded if they were enrolled in health maintenance organizations.
Outcomes included death within 30 days and late survival, perioperative complications, aneurysm rupture, reintervention, and laparotomy-related complications. The average age was 76, and 20% were women. Perioperative mortality was lower after endovascular repair (1.2% vs. 4.8%, p<0.001), and older patients had a greater benefit. Late survival was similar. By four years, rupture was more likely in the endovascular group (1.8% vs. 0.5%, p<0.001), as was reintervention (9% vs. 1.7%, p<0.001).
In contrast, by four years, surgery for laparotomy-related complications was more likely in the open-repair group (9.7% v 4.1%, p<0.001), as was hospitalization for bowel obstruction or abdominal-wall hernia (14.2% v 8.1%, p<0.001). Limitations included the non-randomized design and use of administrative data for important categorical variables including medical co-morbidities.
Bottom line: As compared with open repair, endovascular repair of abdominal aortic aneurysm is associated with lower short-term death and complications and higher late reinterventions. This is balanced by an increase in laparotomy-related reinterventions after open repair.
Citation: Schermerhorn ML, O’Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N Engl J Med. 2008 Jan 31;358(5):464-474.
What Therapy Improves Outcomes in ICU Patients With Severe Sepsis or Septic Shock?
Background: Evidence suggests lower mortality with intensive insulin therapy in post-surgical cardiac patients. There is no proven benefit for non-surgical ICU patients. Despite lack of data, intensive insulin in severe sepsis has been widely advocated. Little is known to guide the use of colloid or crystalloid for fluid resuscitation in sepsis.
Study design: Multicenter, two-by-two factorial, open-label trial.
Setting: Multidisciplinary ICUs at 18 academic tertiary hospitals in Germany.
Synopsis: Data were analyzed for 537 patients with severe sepsis. They were randomly selected to receive intensive insulin therapy (n=247) or conventional insulin therapy (290), with either 10% hydroxyethyl starch (HES) (262) or modified Ringer’s lactate (LR) (275) for fluid resuscitation.
Co-primary endpoints were all-cause mortality at 28 days and morbidity as measured by the mean score on the Sequential Organ Failure Assessment (SOFA). The trial was stopped early for safety reasons. Intensive insulin therapy was terminated due to an increased number of hypoglycemic events in the intensive-therapy group compared with conventional therapy (12.1% vs. 2.1%, p<0.001), and there was no difference in mortality between groups at 28 and 90 days.
Interim analysis of 600 patients showed patients given HES had higher incidence of renal failure compared with LR (34.9% vs. 22.8%, p=0.002), required more days of renal replacement therapy, had lower median platelets and received more units of packed red cells. There was a trend toward higher rate of death at 90 days in those treated with HES (41% vs. 33.9%, p=0.09).
Bottom line: Intensive insulin therapy in ICU patients with severe sepsis and septic shock does not improve mortality and increases hypoglycemia and ICU length of stay. Use of colloid over crystalloid should be avoided, showing a trend toward increased death at 90 days, higher rates of acute renal failure, and need for renal replacement therapy..
Citation: Brunkhorst FM, Engel C, Bloos F, et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008;358(2):125-139.
How Does Laparoscopic Adjustable Gastric Banding Affect Obese Adults With Type 2 Diabetes?
Background: Observational studies related surgical weight loss to improved glycemic control, but clinical trials did not test this relationship. The current trial examined this hypothesis.
Study design: Unmasked, randomized controlled trial.
Setting: University Obesity Research Center, Australia.
Synopsis: Sixty adults age 20-60 with body-mass index (BMI) of 30-40 and diagnosed with diabetes mellitus type 2 (DM2) within two years of recruitment were randomized into conventional therapy and surgical groups.
While both groups were treated similarly, only the surgical group received laparoscopic adjustable gastric banding. Primary outcome was remission of DM2 (a fasting glucose less than 126 mg/dl, HbA1C less than 6.2%, and off all hypoglycemic agents). At two years, 73% in the surgical group compared with 13% in the conventional group attained this outcome (relative risk [RR] 5.5, 95% confidence interval [CI] 2.2-14.0; p<0.001). Compared with the conventional group, the surgical group demonstrated statistically significant improvements in several secondary outcomes including mean body weight, waist circumference, insulin resistance, and lipids.
The limitations of the study are that it examined a small number of patients with shorter duration of DM2 and a shorter follow-up. The lower surgical complication rates cannot be generalized to other centers.
Bottom line: This study is a step forward in examining the relationship of surgical weight loss and remission of DM2. However, large multicenter trials with longer periods of follow-up in diverse group of patients would result in a better understanding of this relationship.
Citation: Dixon JB, O’Brien PE, Playfair J, et. al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008;299(3):316-323.
What is the Prevalence of Delayed Defibrillation and its Association With Survival to Discharge?
Background: Despite advances in resuscitation, survival rates following cardiac arrest remain low. Previous studies observed the effect of the timing of defibrillation on survival. This study examined the magnitude of delayed defibrillation and its association with survival in adults who sustained cardiac arrest specifically from ventricular fibrillation and pulseless ventricular tachycardia.
Study design: National Registry of Cardiopulmonary Resuscitation (NRCPR), a multicenter prospective cohort.
Setting: 369 U.S. hospitals providing acute care.
Synopsis: Data from NRCPR relating to 6,789 cardiac arrests secondary to ventricular fibrillation or pulseless ventricular tachycardia, at 369 hospitals in hospitalized adults were analyzed. Delayed defibrillation was defined as occurring more than two minutes from the identification of ventricular fibrillation or pulseless ventricular tachycardia to the administration of the first shock to the patient.
Delayed defibrillation occurred in 2,045 (30.1%) subjects. A lower proportion of subjects who received delayed defibrillation (22.2%) compared with those who received defibrillation in two minutes or less (39.3%) survived to hospital discharge. This was statistically significant (adjusted odds ratio [OR] 0.48, 95% CI 0.42 to 0.54; p<0.01).
Bottom line: This study not only reported that delayed defibrillation was prevalent in adult hospitalized patients, but also reinforced the importance of defibrillation within two minutes of identification of cardiac arrest secondary to ventricular fibrillation and pulseless ventricular tachycardia for better survival outcomes.
Citation: Chan PS, Krumholz HM, Nichol G, Nallamothu BK. Delayed time to defibrillation after in-hospital cardiac arrest. N Engl J Med. 2008;358(1):9-17.
Does Right-Ventricle Enlargement in Acute PE Increase In-hospital Death From PE or All-cause Mortality?
Background: Previous studies have shown conflicting results regarding the risk of death with right-ventricular enlargement in acute pulmonary embolism (PE). The role of thrombolysis in hemodynamically stable patients with acute PE and right-ventricular enlargement remains controversial.
Study design: Retrospective analysis of prospective cohort study.
Setting: Academic centers housing inpatients and outpatients in the United States and Canada.
Synopsis: Patients enrolled in PIOPED II who were diagnosed with acute PE and had multidetector computed tomographic (CT) angiography were retrospectively reviewed for the presence of right-ventricular enlargement. Study determined that 181 patients had PE and a CT, and 157 were adequate for measurement of right-ventricular size. PE treatment was anticoagulation in 138, anticoagulation and inferior vena cava filter in 15, inferior vena cava filter alone in two, and thrombolysis in two.
Right-ventricular enlargement was found in 78 (50%) patients; 76 were treated with anticoagulation alone or in combination with inferior vena cava filter. For patients with and without right-ventricular enlargement, there was no difference in in-hospital death from PE (0% vs. 1.3%) or all-cause mortality (2.6% vs. 2.5%). The results were unchanged when examined for septal motion abnormality and previous cardiopulmonary disease.
Bottom line: In hemodynamically stable patients with acute pulmonary embolism, right ventricular enlargement does not increase mortality. Further, thrombolytic therapy is unlikely to improve outcomes.
Citation: Stein PD, Beemath A, Matti F, et al. Enlarged right ventricle without shock in acute pulmonary embolus: prognosis. Am J Med. 2008;121:34-42.
What Are Short-term Thromboembolism, Hemorrhage Risks When Interrupting Warfarin Therapy for Procedures?
Background: The risks of thromboembolism and hemorrhage during the periprocedural interruption of warfarin therapy are not known. The risks and benefits of heparin bridging therapy are not well described.
Study design: Multicenter, prospective, observational cohort study.
Setting: Community-based physician practices.
Synopsis: Patients were eligible if they were on long-term warfarin and underwent outpatient procedures requiring interruption of therapy. The primary outcomes were thromboembolism or hemorrhage within 30 days of therapy interruption. In all, 1,024 eligible patients (7.1% considered high risk) had 1,293 interruptions of warfarin therapy. The most common procedures were colonoscopy (25.1%), oral or dental surgery (24.9%), and ophthalmologic surgery (8.9%). Warfarin interruption was five or fewer days in 83.8% of episodes.
Thromboembolism occurred in seven (0.7%) patients, and major or clinically significant bleeding occurred in 23 (0.6%, and 1.7%, respectively) patients. Periprocedural bridging with heparin was used in 88 (8.6%) patients. Of the patients who received periprocedural heparin therapy, none had thromboembolism, and 14 (13%) had bleeding episodes.
Bottom line: In patients whose warfarin therapy is interrupted to undergo outpatient procedures, the risk of thromboembolism is low and the hemorrhagic risk of heparin bridging therapy is significant.
Citation: Garcia DA, Regan S, Henault LE, et al. Risk of thromboembolism with short-term interruption of warfarin therapy. Arch Intern Med. 2008;168(1):63-69.
Are Minor Injuries an Independent Risk Factor For Development of DVT?
Background: Prior studies focus on major injuries as a risk factor for deep-vein thrombosis (DVT) and PE. However, major injury is often associated with other risks for venous thrombosis, such as surgery, plaster casting, hospitalization, and extended bed rest. Risk of DVT with minor injuries that don’t lead to these factors is unknown.
Study design: Large population-based case-control study.
Setting: Six anticoagulation clinics in the Netherlands.
Synopsis: 2,471 consecutive cases (patients with first episode of DVT or PE) and 3,534 controls (partners of cases or random digit dialing contacts) were enrolled. Participants were mailed a questionnaire, including a list of eight common injuries.
Participants with history of cast, surgery, recent hospitalization, extended bed rest, or prior history of cancer were excluded. A subset of patients and controls underwent DNA and blood collection to evaluate for presence of a hypercoagulable state. Of the cases, 289 (11.7%) had a minor injury within three months of the index date, compared with 154 (4.4%) of controls, representing a threefold increased risk of DVT/PE with minor injury (OR 3.1). Partial ruptures of muscles or ligaments in the leg (OR 10.9), multiple simultaneous injuries (OR 9.9), and injury within four weeks of presentation (OR 4.0), were associated with increased risk of DVT/PE.
Patients found to be Factor V Leiden carriers with injury had an almost 50-fold increased risk of venous thromboembolism (VTE) compared with non-carriers without injury (OR 49.7). Authors appropriately address possible limitations, including recall and referral bias.
Bottom line: Minor leg injury is associated with threefold risk of DVT/PE, especially in the four weeks following injury. Providers should consider short-term prophylactic treatment in patients with Factor V Leiden or high-risk injuries.
Citation: Van Stralen KJ, Rosendaal FR, Doggen CJ. Minor injuries as a risk factor for venous thrombosis. Arch Intern Med. 2008;168(1):21-26.
Is Oral Amox-Clav Non-inferior to IV Antibiotics in Pediatric Pyelonephritis?
Background: Present guidelines recommend initial treatment for pediatric pyelonephritis to be a parenteral third-generation cephalosporin followed by oral antibiotics. One prior randomly selected controlled trial compared oral antibiotics only with antibiotics started parenterally, but there was a higher-than-usual incidence of vesicoureteral reflux and female gender in the study.
Study design: Non-inferiority, multicenter, random, open label, controlled trial.
Setting: Twenty-eight pediatric units in northeast Italy from 2000-2005
Synopsis: 502 children age 1 month to less than 7 years with a clinical diagnosis of first occurrence of acute pyelonephritis according to urinalysis and urine culture (requiring two concordant consecutive tests) with at least two of the following conditions: fever of 38 degrees C or more or elevated erythrocyte sedimentation rate (ESR) or c-reactive protein (CRP), and elevated neutrophil count were randomized to receive oral amoxicillin-clavulanate (AC) or parenteral ceftriaxone followed by oral AC. Exclusion criteria were sepsis, dehydration, vomiting, and creatinine clearance of 70 ml/min or less.
Also, 400 children had dimercaptosuccinic acid (DMSA) scintigraphy within 10 days of study entry. Meantime, 223 had repeat DMSA at one year, and 177 had normal scans at study entry so were not repeated. At one year, 20% of patients were lost to follow-up. The primary outcome was renal scarring at one year. Secondary outcomes included time to fever defervescence, reduction in inflammatory indices, and percentage with sterile urine after 72 hours. Intention to treat analysis showed no significant differences between oral (n=244) and parenteral (n=258) treatment, both in the primary outcome 13.7% vs. 17.7% (95% CI, -11.1% to 3.1%), and secondary outcomes.
Bottom line: Treatment with oral antibiotics is as effective as parenteral then oral treatment for first episode of acute pediatric pyelonephritis.
Citation: Montini G, Toffolo A, Zucchetta P, et al. Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial. BMJ. 2007 Aug 25;335(7616):386.