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Reduce CR-BSI
Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-2732.
For practicing clinicians, quality improvement (QI) is a difficult and important task. There can be requirements for extra steps, additional forms, or new safety procedures when caring for patients; there is also the promise of improved clinical outcomes. This tradeoff can be justified when solid, evidence-based techniques are implemented, but—unfortunately—definitive evidence is not always available. Public reporting of a variety of quality indicators, now mandated by the Centers for Medicare and Medicaid Services (CMS), is likely to boost calls for changes in clinical medicine, and the pressure to adopt new safety practices is likely to increase.
Fortunately, this article by Pronovost and colleagues provides a test of state-of-the-art QI theory applied to an important QI target, catheter-related bloodstream infections (CR-BSI). Annually there are 80,000 CR-BSI in the United States, causing about 28,000 deaths in ICU patients; the medical costs to treat these infections is estimated at $2.3 billion. There have been numerous published and unpublished trials of QI methods that have reduced the incidence of such infections, but none have been as large as this one, a state-wide ICU trial conducted in Michigan and funded by the Agency for Healthcare Research and Quality (AHRQ).
One-hundred-three ICUs, representing 85% of ICU beds in the state, participated in the study. In addition to the intervention to reduce CR-BSI, a comprehensive program aimed at instilling a culture of safety was implemented, including the creation of a QI team with a physician and nurse as team leaders, use of a daily goals sheet to enhance clinician-clinician communication, an intervention to reduce ventilator-associated pneumonia, and a comprehensive safety program designed to improve the culture of safety.
The study intervention was designed to improve clinicians’ use of five evidence-based procedures recommended by the Centers for Disease Control and Prevention (CDC):
- Handwashing;
- Use of full barrier precautions;
- Use of chlorhexidine antiseptic;
- Avoidance of femoral line placement; and
- Removal of unnecessary catheters.
The strategies used to encourage these practices were technologically simple and easy to implement. They included the use of a central line kit with a procedure checklist, the termination of any procedure for failure to follow protocol, and daily discussions of line removal on rounds. Additionally, at regular meetings, all clinicians received feedback regarding numbers and rates of CR-BSI.
The results were impressive: The overall rate of CR-BSI decreased from a baseline median of 2.7 (mean, 7.7) infections per 1,000 catheter-days to 0 (mean, 2.3) during the first three-month period after implementation of the intervention (P<0.002). During the 18 months of follow-up, this reduction was sustained at 0 (mean, 1.4). The results applied in both academic and non-teaching hospitals, regardless of size.
Even with such simple methods, managing a statewide implementation of a comprehensive QI program is a feat of organization, as anyone who has implemented even small-scale projects knows. An accompanying editorial praised the effort, noting the magnitude of the accomplishment and recommending widespread adoption of these simple yet effective techniques. Given the push toward the adoption of similar methods, this demonstration is welcome and makes the wholesale acceptance of such measures not only easier but also imperative.
Quality Performance Measures across the Nation
Landon BE, Normand SL, Lessler A, et al. Quality of care for the treatment of acute medical conditions in US hospitals. Arch Intern Med. 2006 Dec 11;166(22):2511-2517.
Background
Current efforts have focused on examining and reporting indicators in order to increase the quality of care provided to patients in the United States. In January 2004 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) began collecting monthly data from its accredited hospitals on performance measures across three of five select disease conditions. Similarly, since 2004, CMS has provided data from Hospital Quality Alliance members on 10 performance measures in the areas of congestive heart failure, acute myocardial infarction, and pneumonia. This study collected data from these reports to expand on previous work examining the quality of care in the United States on a national level. It also analyzed the characteristics of hospitals that have met these quality measures.
Methods
Overall, 4,856 different hospitals were included in the analysis. Data was obtained for all relevant discharges between January 1 and June 2004 from both CMS and JCAHO, with preference given to the JCAHO data. Discrepancies in reporting data between the two data sets were less than 1%. The 2003 Annual Survey of Hospitals from the American Hospital Association (AHA) was used to define the population of hospitals operating in the United States in terms of:
- Number of beds;
- Ownership (for-profit, not-for-profit, government, or military);
- Region;
- Metropolitan statistical area type (rural, small, medium, or large);
- Teaching status (major—member of the Council of Teaching Hospitals, minor—any other medical school affiliation or residency program, or non-teaching);
- Availability of advanced technology (MRI and PET scanning);
- Nurse staffing patterns; and
- Number of Medicaid and Medicare discharges.
These data sets were linked. Composite scales were created for each disease. Bivariate associations using two-tailed T-tests for continuous variables and chi-squared tests for categorical variables were made. For each individual and composite measure, the mean performance and the 25th and 75th percentiles were calculated. The top performing quintiles for each of the three diseases were taken and cross-tabulated across the three specific disease composites. A random-effects logistic regression model was estimated for each composite using a binary logistic model with SAS statistical software and the grouped hospital data that modeled the number of opportunities met in each hospital out of the total number of opportunities at the hospital.
Results
Hospitalized patients with congestive heart failure, acute myocardial infarction, and pneumonia received 75.9% of the recommended processes of care as a whole. Performance varied considerably, from a mean of 0.36 (0.00-0.67) for thrombolytic therapy administered within 30 minutes of arrival for an MI to a mean of 0.98 (0.98-1.00) for assessment of oxygen for patients with pneumonia. Mean composite scores were 0.85 (0.81-0.95) for acute myocardial infarction, 0.64 (0.52-0.78) for congestive heart failure, and 0.88 (0.80-0.97) for pneumonia.
When comparing hospitals in quintiles of performance, 10.5% were in the top quintile for two out of three diseases, but only 3.8% were in the top quintile for all three diseases. “Treatment and diagnosis” as well as “counseling and prevention” were correlated among all three conditions after factor analysis.
Multivariate analysis demonstrated for-profit hospitals as consistently performing worse than not-for-profit hospitals in meeting performance measures. Federal and military hospitals had the highest success in meeting the measures for the three diseases analyzed. Major teaching hospitals met more quality indicators for patients with acute MI and “treatment and diagnosis” but not for CHF, pneumonia, or “counseling and prevention” when compared with non-teaching hospitals. Performance decreased as the share of Medicaid patients increased. More technology and a registered nursing staff with more education were factors associated with higher success in meeting quality indicators.
Conclusions
This ambitious study evaluated the quality of hospital care across the nation using information collected from both JCAHO and CMS. It demonstrated room for improvement, with hospitals as a whole providing 76% of the recommended measures for acute MI, CHF, and pneumonia. The study suggests that ownership characteristics, teaching status, JCAHO accreditation, technology investments, and nursing staff with degrees strongly correlates to success in meeting performance measures.
The authors conclude that the findings have implications for public policy and patient choice. They hypothesize that regions of the country and rural locations more often associated with low performance could use additional resources aimed at bolstering performance. Patients living in rural areas have little choice without traveling great distances. The authors also state that the characteristics of hospitals that influence performance, such as ownership, teaching status, JCAHO accreditation, technology investments, and nursing status, are remediable.
It is important to bear in mind, however, given the cross-sectional nature of the data, that the associations reported are not proof of causality. Quality performance measures were not highly correlated among hospitals for the three conditions studied, with only 3.8% in the top quintile for all three diseases; this result demonstrates the difficulty inherent in generically rating hospitals. Additionally, this study makes no attempt to examine how meeting performance measures affects clinical outcomes, an important part of this ongoing national debate.
Treat DVT
Kearon C, Ginsberg JS, Julian JA, et al. Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism. JAMA. 2006 Aug 23;296(8):935-942.
Background
The current practice of treating DVT involves starting the patient on LMW (low molecular weight) heparin administered subcutaneously or initiating an IV drip of unfractionated heparin. The latter prevents the patient from being discharged as soon as treatment is initiated and requires repeat checking of aPTTs and drip adjustments, which may lead to over-shoot and/or sub-therapeutic dosage. On the other hand, treatment with LMW heparin is costly and can be tricky for patients with varying degrees of renal failure. Using fixed-dose subcutaneous injections of unfractionated heparin is a novel idea and could be the solution to the above-mentioned issues.
Methods
Eight hospitals in Canada and New Zealand with a total of 708 eligible and willing participants were involved in the study. The study design was a randomized, controlled, non-inferiority trial; the adjudication and monitoring committees were blinded. Patients older than 18 with a new diagnosis of DVT and/or pulmonary embolism were considered eligible. Patients with any of the usual contraindications for anticoagulation, including recent major bleeding events, were excluded, as were patients with renal failure and pregnancy.
Computerized randomization was done at a central location, and patients were started on either twice daily weight-based dosing of LMW heparin (100 IU/kg) or twice daily dosing of weight-based unfractionated heparin (first dose of 333 U/kg, subsequent doses of 250 U/kg). No coagulation testing was done to modify these doses. The patients were treated for at least five days, until the International Normalized Ratio (INR) was in the therapeutic range for two consecutive days. Patients were concomitantly started on warfarin. Recurrent venous thromboses, bleeding episodes—described as drop of hemoglobin >2.0—and death were primary endpoints.
Results
The assumption of non-inferiority was supported by the analysis of recurrent VTEs, which were 12 (3.4%) in the LMW heparin group and 13 (3.8%) in the unfractionated heparin group—clinically, a non-significant difference. Bleeding rates at 10 days or at three months were not significantly different for the two groups. Number of deaths was 18 in the unfractionated heparin group and 22 in the LMW heparin group. No patients were reported to have developed heparin-induced thrombocytopenia, a serious and often life-threatening complication of unfractionated heparin use.
Conclusions
This interesting study demonstrates that the use of fixed dose, unmonitored, subcutaneous unfractionated heparin in twice daily dosing is non-inferior to treatment with different kinds of LMW heparin. The authors have also analyzed the cost difference, which, at existing U.S. pricing, would be in the vicinity of $675 for the six-day treatment of an 80-kg patient. Though more data is needed on patients with special considerations such as renal failure, the results, which support non-inferiority and cite a major cost advantage, merit further studies to validate these conclusions and to further evaluate this approach in patient populations with special considerations.
Non-Invasive Testing Prior to Vascular Surgery
Poldermans D, Bax JJ, Schouten O, et al. Should major vascular surgery be delayed because of preoperative cardiac testing in intermediate-risk patients receiving beta-blocker therapy with tight heart rate control? J Am Coll Cardiol. 2006 Sep 5;48(5):964-969.
Background
Current guidelines from the AHA and the American College of Cardiology (ACC) recommend non-invasive testing for patients scheduled for major vascular surgery as part of the pre-operative work-up if they have clinical factors suggestive of increased cardiac risk. The study was performed to show that no testing combined with aggressive beta blockade is not inferior in comparison to non-invasive testing for patients in the intermediate risk group who are preparing to undergo major vascular surgery. Testing often results in delays that can result in poor outcomes; additionally, invasive intervention based upon non-invasive test results has not been clearly shown to add any benefit to the eventual outcome of the patient.
Methods
The study was conducted at five clinical centers in Europe and Brazil, where 1,476 patients undergoing elective open abdominal aortic or infrainguinal arterial reconstruction were enrolled. The design was a randomized, controlled, non-inferiority trial with the outcome assessors blinded. Inclusion criteria consisted of age older than 70, angina pectoris, prior myocardial infarction (MI), compensated or history of congestive heart failure, diabetes mellitus, renal dysfunction and prior stroke, or transient ischemic attack. Patients with one or two risk factors were labeled intermediate risk and were randomized to receive either just beta-blocker therapy or non-invasive testing with dobutamine echocardiography or dobutamine or dipyridamole perfusion scintigraphy.
Patients with limited or no ischemia were referred for surgery with beta-blocker therapy. In patients with extensive ischemia—five ischemic segments or more—coronary angiography and revascularization were performed if the main surgery could be delayed. Beta-blocker therapy was instituted in all patients, with a goal heart rate of 60-65. The beta-blocker therapy was continued postoperatively. IV metoprolol was used in the ICU if a patient could not take drugs orally. Primary endpoints were a combination of cardiac death and nonfatal MI at 30 days and two years.
Results
Of the 770 patients classified as intermediate risk, 386 received cardiac testing and 384 patients were not tested. There were no significant differences in the presence of ischemic heart disease in the two subsets. The time gap between screening to vascular surgery was 34 days (seven to 88 days) in the no testing group, compared with 53 days (1,321 days) in the testing group (P<0.001). There was no difference in the composite endpoints—either at 30 days or at two years—for the two groups.
Conclusions
This excellent study shows that the approach of no screening in patients with intermediate cardiac risk factors before vascular surgery is non-inferior. An interesting point elucidated by the authors in their discussion details why studies designed to achieve a goal heart rate, rather than those based on fixed dose beta-blockers, are ideal to show the benefits of beta blockade in this population subset. The benefit of coronary revascularization for intermediate risk patients with extensive ischemia could not be defined, however; the number was too small to show any significance.
Reduce CR-BSI
Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-2732.
For practicing clinicians, quality improvement (QI) is a difficult and important task. There can be requirements for extra steps, additional forms, or new safety procedures when caring for patients; there is also the promise of improved clinical outcomes. This tradeoff can be justified when solid, evidence-based techniques are implemented, but—unfortunately—definitive evidence is not always available. Public reporting of a variety of quality indicators, now mandated by the Centers for Medicare and Medicaid Services (CMS), is likely to boost calls for changes in clinical medicine, and the pressure to adopt new safety practices is likely to increase.
Fortunately, this article by Pronovost and colleagues provides a test of state-of-the-art QI theory applied to an important QI target, catheter-related bloodstream infections (CR-BSI). Annually there are 80,000 CR-BSI in the United States, causing about 28,000 deaths in ICU patients; the medical costs to treat these infections is estimated at $2.3 billion. There have been numerous published and unpublished trials of QI methods that have reduced the incidence of such infections, but none have been as large as this one, a state-wide ICU trial conducted in Michigan and funded by the Agency for Healthcare Research and Quality (AHRQ).
One-hundred-three ICUs, representing 85% of ICU beds in the state, participated in the study. In addition to the intervention to reduce CR-BSI, a comprehensive program aimed at instilling a culture of safety was implemented, including the creation of a QI team with a physician and nurse as team leaders, use of a daily goals sheet to enhance clinician-clinician communication, an intervention to reduce ventilator-associated pneumonia, and a comprehensive safety program designed to improve the culture of safety.
The study intervention was designed to improve clinicians’ use of five evidence-based procedures recommended by the Centers for Disease Control and Prevention (CDC):
- Handwashing;
- Use of full barrier precautions;
- Use of chlorhexidine antiseptic;
- Avoidance of femoral line placement; and
- Removal of unnecessary catheters.
The strategies used to encourage these practices were technologically simple and easy to implement. They included the use of a central line kit with a procedure checklist, the termination of any procedure for failure to follow protocol, and daily discussions of line removal on rounds. Additionally, at regular meetings, all clinicians received feedback regarding numbers and rates of CR-BSI.
The results were impressive: The overall rate of CR-BSI decreased from a baseline median of 2.7 (mean, 7.7) infections per 1,000 catheter-days to 0 (mean, 2.3) during the first three-month period after implementation of the intervention (P<0.002). During the 18 months of follow-up, this reduction was sustained at 0 (mean, 1.4). The results applied in both academic and non-teaching hospitals, regardless of size.
Even with such simple methods, managing a statewide implementation of a comprehensive QI program is a feat of organization, as anyone who has implemented even small-scale projects knows. An accompanying editorial praised the effort, noting the magnitude of the accomplishment and recommending widespread adoption of these simple yet effective techniques. Given the push toward the adoption of similar methods, this demonstration is welcome and makes the wholesale acceptance of such measures not only easier but also imperative.
Quality Performance Measures across the Nation
Landon BE, Normand SL, Lessler A, et al. Quality of care for the treatment of acute medical conditions in US hospitals. Arch Intern Med. 2006 Dec 11;166(22):2511-2517.
Background
Current efforts have focused on examining and reporting indicators in order to increase the quality of care provided to patients in the United States. In January 2004 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) began collecting monthly data from its accredited hospitals on performance measures across three of five select disease conditions. Similarly, since 2004, CMS has provided data from Hospital Quality Alliance members on 10 performance measures in the areas of congestive heart failure, acute myocardial infarction, and pneumonia. This study collected data from these reports to expand on previous work examining the quality of care in the United States on a national level. It also analyzed the characteristics of hospitals that have met these quality measures.
Methods
Overall, 4,856 different hospitals were included in the analysis. Data was obtained for all relevant discharges between January 1 and June 2004 from both CMS and JCAHO, with preference given to the JCAHO data. Discrepancies in reporting data between the two data sets were less than 1%. The 2003 Annual Survey of Hospitals from the American Hospital Association (AHA) was used to define the population of hospitals operating in the United States in terms of:
- Number of beds;
- Ownership (for-profit, not-for-profit, government, or military);
- Region;
- Metropolitan statistical area type (rural, small, medium, or large);
- Teaching status (major—member of the Council of Teaching Hospitals, minor—any other medical school affiliation or residency program, or non-teaching);
- Availability of advanced technology (MRI and PET scanning);
- Nurse staffing patterns; and
- Number of Medicaid and Medicare discharges.
These data sets were linked. Composite scales were created for each disease. Bivariate associations using two-tailed T-tests for continuous variables and chi-squared tests for categorical variables were made. For each individual and composite measure, the mean performance and the 25th and 75th percentiles were calculated. The top performing quintiles for each of the three diseases were taken and cross-tabulated across the three specific disease composites. A random-effects logistic regression model was estimated for each composite using a binary logistic model with SAS statistical software and the grouped hospital data that modeled the number of opportunities met in each hospital out of the total number of opportunities at the hospital.
Results
Hospitalized patients with congestive heart failure, acute myocardial infarction, and pneumonia received 75.9% of the recommended processes of care as a whole. Performance varied considerably, from a mean of 0.36 (0.00-0.67) for thrombolytic therapy administered within 30 minutes of arrival for an MI to a mean of 0.98 (0.98-1.00) for assessment of oxygen for patients with pneumonia. Mean composite scores were 0.85 (0.81-0.95) for acute myocardial infarction, 0.64 (0.52-0.78) for congestive heart failure, and 0.88 (0.80-0.97) for pneumonia.
When comparing hospitals in quintiles of performance, 10.5% were in the top quintile for two out of three diseases, but only 3.8% were in the top quintile for all three diseases. “Treatment and diagnosis” as well as “counseling and prevention” were correlated among all three conditions after factor analysis.
Multivariate analysis demonstrated for-profit hospitals as consistently performing worse than not-for-profit hospitals in meeting performance measures. Federal and military hospitals had the highest success in meeting the measures for the three diseases analyzed. Major teaching hospitals met more quality indicators for patients with acute MI and “treatment and diagnosis” but not for CHF, pneumonia, or “counseling and prevention” when compared with non-teaching hospitals. Performance decreased as the share of Medicaid patients increased. More technology and a registered nursing staff with more education were factors associated with higher success in meeting quality indicators.
Conclusions
This ambitious study evaluated the quality of hospital care across the nation using information collected from both JCAHO and CMS. It demonstrated room for improvement, with hospitals as a whole providing 76% of the recommended measures for acute MI, CHF, and pneumonia. The study suggests that ownership characteristics, teaching status, JCAHO accreditation, technology investments, and nursing staff with degrees strongly correlates to success in meeting performance measures.
The authors conclude that the findings have implications for public policy and patient choice. They hypothesize that regions of the country and rural locations more often associated with low performance could use additional resources aimed at bolstering performance. Patients living in rural areas have little choice without traveling great distances. The authors also state that the characteristics of hospitals that influence performance, such as ownership, teaching status, JCAHO accreditation, technology investments, and nursing status, are remediable.
It is important to bear in mind, however, given the cross-sectional nature of the data, that the associations reported are not proof of causality. Quality performance measures were not highly correlated among hospitals for the three conditions studied, with only 3.8% in the top quintile for all three diseases; this result demonstrates the difficulty inherent in generically rating hospitals. Additionally, this study makes no attempt to examine how meeting performance measures affects clinical outcomes, an important part of this ongoing national debate.
Treat DVT
Kearon C, Ginsberg JS, Julian JA, et al. Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism. JAMA. 2006 Aug 23;296(8):935-942.
Background
The current practice of treating DVT involves starting the patient on LMW (low molecular weight) heparin administered subcutaneously or initiating an IV drip of unfractionated heparin. The latter prevents the patient from being discharged as soon as treatment is initiated and requires repeat checking of aPTTs and drip adjustments, which may lead to over-shoot and/or sub-therapeutic dosage. On the other hand, treatment with LMW heparin is costly and can be tricky for patients with varying degrees of renal failure. Using fixed-dose subcutaneous injections of unfractionated heparin is a novel idea and could be the solution to the above-mentioned issues.
Methods
Eight hospitals in Canada and New Zealand with a total of 708 eligible and willing participants were involved in the study. The study design was a randomized, controlled, non-inferiority trial; the adjudication and monitoring committees were blinded. Patients older than 18 with a new diagnosis of DVT and/or pulmonary embolism were considered eligible. Patients with any of the usual contraindications for anticoagulation, including recent major bleeding events, were excluded, as were patients with renal failure and pregnancy.
Computerized randomization was done at a central location, and patients were started on either twice daily weight-based dosing of LMW heparin (100 IU/kg) or twice daily dosing of weight-based unfractionated heparin (first dose of 333 U/kg, subsequent doses of 250 U/kg). No coagulation testing was done to modify these doses. The patients were treated for at least five days, until the International Normalized Ratio (INR) was in the therapeutic range for two consecutive days. Patients were concomitantly started on warfarin. Recurrent venous thromboses, bleeding episodes—described as drop of hemoglobin >2.0—and death were primary endpoints.
Results
The assumption of non-inferiority was supported by the analysis of recurrent VTEs, which were 12 (3.4%) in the LMW heparin group and 13 (3.8%) in the unfractionated heparin group—clinically, a non-significant difference. Bleeding rates at 10 days or at three months were not significantly different for the two groups. Number of deaths was 18 in the unfractionated heparin group and 22 in the LMW heparin group. No patients were reported to have developed heparin-induced thrombocytopenia, a serious and often life-threatening complication of unfractionated heparin use.
Conclusions
This interesting study demonstrates that the use of fixed dose, unmonitored, subcutaneous unfractionated heparin in twice daily dosing is non-inferior to treatment with different kinds of LMW heparin. The authors have also analyzed the cost difference, which, at existing U.S. pricing, would be in the vicinity of $675 for the six-day treatment of an 80-kg patient. Though more data is needed on patients with special considerations such as renal failure, the results, which support non-inferiority and cite a major cost advantage, merit further studies to validate these conclusions and to further evaluate this approach in patient populations with special considerations.
Non-Invasive Testing Prior to Vascular Surgery
Poldermans D, Bax JJ, Schouten O, et al. Should major vascular surgery be delayed because of preoperative cardiac testing in intermediate-risk patients receiving beta-blocker therapy with tight heart rate control? J Am Coll Cardiol. 2006 Sep 5;48(5):964-969.
Background
Current guidelines from the AHA and the American College of Cardiology (ACC) recommend non-invasive testing for patients scheduled for major vascular surgery as part of the pre-operative work-up if they have clinical factors suggestive of increased cardiac risk. The study was performed to show that no testing combined with aggressive beta blockade is not inferior in comparison to non-invasive testing for patients in the intermediate risk group who are preparing to undergo major vascular surgery. Testing often results in delays that can result in poor outcomes; additionally, invasive intervention based upon non-invasive test results has not been clearly shown to add any benefit to the eventual outcome of the patient.
Methods
The study was conducted at five clinical centers in Europe and Brazil, where 1,476 patients undergoing elective open abdominal aortic or infrainguinal arterial reconstruction were enrolled. The design was a randomized, controlled, non-inferiority trial with the outcome assessors blinded. Inclusion criteria consisted of age older than 70, angina pectoris, prior myocardial infarction (MI), compensated or history of congestive heart failure, diabetes mellitus, renal dysfunction and prior stroke, or transient ischemic attack. Patients with one or two risk factors were labeled intermediate risk and were randomized to receive either just beta-blocker therapy or non-invasive testing with dobutamine echocardiography or dobutamine or dipyridamole perfusion scintigraphy.
Patients with limited or no ischemia were referred for surgery with beta-blocker therapy. In patients with extensive ischemia—five ischemic segments or more—coronary angiography and revascularization were performed if the main surgery could be delayed. Beta-blocker therapy was instituted in all patients, with a goal heart rate of 60-65. The beta-blocker therapy was continued postoperatively. IV metoprolol was used in the ICU if a patient could not take drugs orally. Primary endpoints were a combination of cardiac death and nonfatal MI at 30 days and two years.
Results
Of the 770 patients classified as intermediate risk, 386 received cardiac testing and 384 patients were not tested. There were no significant differences in the presence of ischemic heart disease in the two subsets. The time gap between screening to vascular surgery was 34 days (seven to 88 days) in the no testing group, compared with 53 days (1,321 days) in the testing group (P<0.001). There was no difference in the composite endpoints—either at 30 days or at two years—for the two groups.
Conclusions
This excellent study shows that the approach of no screening in patients with intermediate cardiac risk factors before vascular surgery is non-inferior. An interesting point elucidated by the authors in their discussion details why studies designed to achieve a goal heart rate, rather than those based on fixed dose beta-blockers, are ideal to show the benefits of beta blockade in this population subset. The benefit of coronary revascularization for intermediate risk patients with extensive ischemia could not be defined, however; the number was too small to show any significance.
Reduce CR-BSI
Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-2732.
For practicing clinicians, quality improvement (QI) is a difficult and important task. There can be requirements for extra steps, additional forms, or new safety procedures when caring for patients; there is also the promise of improved clinical outcomes. This tradeoff can be justified when solid, evidence-based techniques are implemented, but—unfortunately—definitive evidence is not always available. Public reporting of a variety of quality indicators, now mandated by the Centers for Medicare and Medicaid Services (CMS), is likely to boost calls for changes in clinical medicine, and the pressure to adopt new safety practices is likely to increase.
Fortunately, this article by Pronovost and colleagues provides a test of state-of-the-art QI theory applied to an important QI target, catheter-related bloodstream infections (CR-BSI). Annually there are 80,000 CR-BSI in the United States, causing about 28,000 deaths in ICU patients; the medical costs to treat these infections is estimated at $2.3 billion. There have been numerous published and unpublished trials of QI methods that have reduced the incidence of such infections, but none have been as large as this one, a state-wide ICU trial conducted in Michigan and funded by the Agency for Healthcare Research and Quality (AHRQ).
One-hundred-three ICUs, representing 85% of ICU beds in the state, participated in the study. In addition to the intervention to reduce CR-BSI, a comprehensive program aimed at instilling a culture of safety was implemented, including the creation of a QI team with a physician and nurse as team leaders, use of a daily goals sheet to enhance clinician-clinician communication, an intervention to reduce ventilator-associated pneumonia, and a comprehensive safety program designed to improve the culture of safety.
The study intervention was designed to improve clinicians’ use of five evidence-based procedures recommended by the Centers for Disease Control and Prevention (CDC):
- Handwashing;
- Use of full barrier precautions;
- Use of chlorhexidine antiseptic;
- Avoidance of femoral line placement; and
- Removal of unnecessary catheters.
The strategies used to encourage these practices were technologically simple and easy to implement. They included the use of a central line kit with a procedure checklist, the termination of any procedure for failure to follow protocol, and daily discussions of line removal on rounds. Additionally, at regular meetings, all clinicians received feedback regarding numbers and rates of CR-BSI.
The results were impressive: The overall rate of CR-BSI decreased from a baseline median of 2.7 (mean, 7.7) infections per 1,000 catheter-days to 0 (mean, 2.3) during the first three-month period after implementation of the intervention (P<0.002). During the 18 months of follow-up, this reduction was sustained at 0 (mean, 1.4). The results applied in both academic and non-teaching hospitals, regardless of size.
Even with such simple methods, managing a statewide implementation of a comprehensive QI program is a feat of organization, as anyone who has implemented even small-scale projects knows. An accompanying editorial praised the effort, noting the magnitude of the accomplishment and recommending widespread adoption of these simple yet effective techniques. Given the push toward the adoption of similar methods, this demonstration is welcome and makes the wholesale acceptance of such measures not only easier but also imperative.
Quality Performance Measures across the Nation
Landon BE, Normand SL, Lessler A, et al. Quality of care for the treatment of acute medical conditions in US hospitals. Arch Intern Med. 2006 Dec 11;166(22):2511-2517.
Background
Current efforts have focused on examining and reporting indicators in order to increase the quality of care provided to patients in the United States. In January 2004 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) began collecting monthly data from its accredited hospitals on performance measures across three of five select disease conditions. Similarly, since 2004, CMS has provided data from Hospital Quality Alliance members on 10 performance measures in the areas of congestive heart failure, acute myocardial infarction, and pneumonia. This study collected data from these reports to expand on previous work examining the quality of care in the United States on a national level. It also analyzed the characteristics of hospitals that have met these quality measures.
Methods
Overall, 4,856 different hospitals were included in the analysis. Data was obtained for all relevant discharges between January 1 and June 2004 from both CMS and JCAHO, with preference given to the JCAHO data. Discrepancies in reporting data between the two data sets were less than 1%. The 2003 Annual Survey of Hospitals from the American Hospital Association (AHA) was used to define the population of hospitals operating in the United States in terms of:
- Number of beds;
- Ownership (for-profit, not-for-profit, government, or military);
- Region;
- Metropolitan statistical area type (rural, small, medium, or large);
- Teaching status (major—member of the Council of Teaching Hospitals, minor—any other medical school affiliation or residency program, or non-teaching);
- Availability of advanced technology (MRI and PET scanning);
- Nurse staffing patterns; and
- Number of Medicaid and Medicare discharges.
These data sets were linked. Composite scales were created for each disease. Bivariate associations using two-tailed T-tests for continuous variables and chi-squared tests for categorical variables were made. For each individual and composite measure, the mean performance and the 25th and 75th percentiles were calculated. The top performing quintiles for each of the three diseases were taken and cross-tabulated across the three specific disease composites. A random-effects logistic regression model was estimated for each composite using a binary logistic model with SAS statistical software and the grouped hospital data that modeled the number of opportunities met in each hospital out of the total number of opportunities at the hospital.
Results
Hospitalized patients with congestive heart failure, acute myocardial infarction, and pneumonia received 75.9% of the recommended processes of care as a whole. Performance varied considerably, from a mean of 0.36 (0.00-0.67) for thrombolytic therapy administered within 30 minutes of arrival for an MI to a mean of 0.98 (0.98-1.00) for assessment of oxygen for patients with pneumonia. Mean composite scores were 0.85 (0.81-0.95) for acute myocardial infarction, 0.64 (0.52-0.78) for congestive heart failure, and 0.88 (0.80-0.97) for pneumonia.
When comparing hospitals in quintiles of performance, 10.5% were in the top quintile for two out of three diseases, but only 3.8% were in the top quintile for all three diseases. “Treatment and diagnosis” as well as “counseling and prevention” were correlated among all three conditions after factor analysis.
Multivariate analysis demonstrated for-profit hospitals as consistently performing worse than not-for-profit hospitals in meeting performance measures. Federal and military hospitals had the highest success in meeting the measures for the three diseases analyzed. Major teaching hospitals met more quality indicators for patients with acute MI and “treatment and diagnosis” but not for CHF, pneumonia, or “counseling and prevention” when compared with non-teaching hospitals. Performance decreased as the share of Medicaid patients increased. More technology and a registered nursing staff with more education were factors associated with higher success in meeting quality indicators.
Conclusions
This ambitious study evaluated the quality of hospital care across the nation using information collected from both JCAHO and CMS. It demonstrated room for improvement, with hospitals as a whole providing 76% of the recommended measures for acute MI, CHF, and pneumonia. The study suggests that ownership characteristics, teaching status, JCAHO accreditation, technology investments, and nursing staff with degrees strongly correlates to success in meeting performance measures.
The authors conclude that the findings have implications for public policy and patient choice. They hypothesize that regions of the country and rural locations more often associated with low performance could use additional resources aimed at bolstering performance. Patients living in rural areas have little choice without traveling great distances. The authors also state that the characteristics of hospitals that influence performance, such as ownership, teaching status, JCAHO accreditation, technology investments, and nursing status, are remediable.
It is important to bear in mind, however, given the cross-sectional nature of the data, that the associations reported are not proof of causality. Quality performance measures were not highly correlated among hospitals for the three conditions studied, with only 3.8% in the top quintile for all three diseases; this result demonstrates the difficulty inherent in generically rating hospitals. Additionally, this study makes no attempt to examine how meeting performance measures affects clinical outcomes, an important part of this ongoing national debate.
Treat DVT
Kearon C, Ginsberg JS, Julian JA, et al. Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism. JAMA. 2006 Aug 23;296(8):935-942.
Background
The current practice of treating DVT involves starting the patient on LMW (low molecular weight) heparin administered subcutaneously or initiating an IV drip of unfractionated heparin. The latter prevents the patient from being discharged as soon as treatment is initiated and requires repeat checking of aPTTs and drip adjustments, which may lead to over-shoot and/or sub-therapeutic dosage. On the other hand, treatment with LMW heparin is costly and can be tricky for patients with varying degrees of renal failure. Using fixed-dose subcutaneous injections of unfractionated heparin is a novel idea and could be the solution to the above-mentioned issues.
Methods
Eight hospitals in Canada and New Zealand with a total of 708 eligible and willing participants were involved in the study. The study design was a randomized, controlled, non-inferiority trial; the adjudication and monitoring committees were blinded. Patients older than 18 with a new diagnosis of DVT and/or pulmonary embolism were considered eligible. Patients with any of the usual contraindications for anticoagulation, including recent major bleeding events, were excluded, as were patients with renal failure and pregnancy.
Computerized randomization was done at a central location, and patients were started on either twice daily weight-based dosing of LMW heparin (100 IU/kg) or twice daily dosing of weight-based unfractionated heparin (first dose of 333 U/kg, subsequent doses of 250 U/kg). No coagulation testing was done to modify these doses. The patients were treated for at least five days, until the International Normalized Ratio (INR) was in the therapeutic range for two consecutive days. Patients were concomitantly started on warfarin. Recurrent venous thromboses, bleeding episodes—described as drop of hemoglobin >2.0—and death were primary endpoints.
Results
The assumption of non-inferiority was supported by the analysis of recurrent VTEs, which were 12 (3.4%) in the LMW heparin group and 13 (3.8%) in the unfractionated heparin group—clinically, a non-significant difference. Bleeding rates at 10 days or at three months were not significantly different for the two groups. Number of deaths was 18 in the unfractionated heparin group and 22 in the LMW heparin group. No patients were reported to have developed heparin-induced thrombocytopenia, a serious and often life-threatening complication of unfractionated heparin use.
Conclusions
This interesting study demonstrates that the use of fixed dose, unmonitored, subcutaneous unfractionated heparin in twice daily dosing is non-inferior to treatment with different kinds of LMW heparin. The authors have also analyzed the cost difference, which, at existing U.S. pricing, would be in the vicinity of $675 for the six-day treatment of an 80-kg patient. Though more data is needed on patients with special considerations such as renal failure, the results, which support non-inferiority and cite a major cost advantage, merit further studies to validate these conclusions and to further evaluate this approach in patient populations with special considerations.
Non-Invasive Testing Prior to Vascular Surgery
Poldermans D, Bax JJ, Schouten O, et al. Should major vascular surgery be delayed because of preoperative cardiac testing in intermediate-risk patients receiving beta-blocker therapy with tight heart rate control? J Am Coll Cardiol. 2006 Sep 5;48(5):964-969.
Background
Current guidelines from the AHA and the American College of Cardiology (ACC) recommend non-invasive testing for patients scheduled for major vascular surgery as part of the pre-operative work-up if they have clinical factors suggestive of increased cardiac risk. The study was performed to show that no testing combined with aggressive beta blockade is not inferior in comparison to non-invasive testing for patients in the intermediate risk group who are preparing to undergo major vascular surgery. Testing often results in delays that can result in poor outcomes; additionally, invasive intervention based upon non-invasive test results has not been clearly shown to add any benefit to the eventual outcome of the patient.
Methods
The study was conducted at five clinical centers in Europe and Brazil, where 1,476 patients undergoing elective open abdominal aortic or infrainguinal arterial reconstruction were enrolled. The design was a randomized, controlled, non-inferiority trial with the outcome assessors blinded. Inclusion criteria consisted of age older than 70, angina pectoris, prior myocardial infarction (MI), compensated or history of congestive heart failure, diabetes mellitus, renal dysfunction and prior stroke, or transient ischemic attack. Patients with one or two risk factors were labeled intermediate risk and were randomized to receive either just beta-blocker therapy or non-invasive testing with dobutamine echocardiography or dobutamine or dipyridamole perfusion scintigraphy.
Patients with limited or no ischemia were referred for surgery with beta-blocker therapy. In patients with extensive ischemia—five ischemic segments or more—coronary angiography and revascularization were performed if the main surgery could be delayed. Beta-blocker therapy was instituted in all patients, with a goal heart rate of 60-65. The beta-blocker therapy was continued postoperatively. IV metoprolol was used in the ICU if a patient could not take drugs orally. Primary endpoints were a combination of cardiac death and nonfatal MI at 30 days and two years.
Results
Of the 770 patients classified as intermediate risk, 386 received cardiac testing and 384 patients were not tested. There were no significant differences in the presence of ischemic heart disease in the two subsets. The time gap between screening to vascular surgery was 34 days (seven to 88 days) in the no testing group, compared with 53 days (1,321 days) in the testing group (P<0.001). There was no difference in the composite endpoints—either at 30 days or at two years—for the two groups.
Conclusions
This excellent study shows that the approach of no screening in patients with intermediate cardiac risk factors before vascular surgery is non-inferior. An interesting point elucidated by the authors in their discussion details why studies designed to achieve a goal heart rate, rather than those based on fixed dose beta-blockers, are ideal to show the benefits of beta blockade in this population subset. The benefit of coronary revascularization for intermediate risk patients with extensive ischemia could not be defined, however; the number was too small to show any significance.