OBJECTIVES: The benefits of statin therapy for patients with coronary artery disease have been well documented, including those occurring after coronary artery bypass graft surgery. The purposes of this study were to assess statin prescription rates in patients who have undergone coronary artery bypass graft surgery and to identify the determinants of postoperative statin administration. METHODS: A retrospective cohort of 9284 Medicare patients aged 65 years or older who underwent coronary artery bypass graft surgery (1995-2004) was assembled by using linked hospital and pharmacy claims data. Rates of statin use after hospital discharge were calculated, and predictors of postoperative statin use were identified by using generalized estimating equations. RESULTS: Overall, 35.9% of patients received statins within 90 days of coronary artery bypass graft surgery discharge. Use of statins within 90 days after coronary artery bypass graft surgery steadily improved during the study period, from 13.1% in 1995 to 60.9% in 2004. Patient factors independently associated with an increase in postoperative statin therapy included preoperative statin use (odds ratio, 7.69), later year of operation (odds ratio, 1.22 per additional year), and additional postoperative medications (odds ratio, 1.16 per additional medication). Factors independently associated with a decrease in postoperative statin therapy included peripheral vascular disease (odds ratio, 0.60), diabetes mellitus (odds ratio, 0.67), stroke (odds ratio, 0.77), and older age (odds ratio, 0.96 per additional year). Surgeon and hospital characteristics were not independently associated with postoperative statin use. CONCLUSIONS: Statins are considerably underused after coronary artery bypass graft surgery, although recent prescription rates are increasing. Patterns of use do not appear to correlate with coronary artery disease risk. These findings highlight the need for targeted quality improvement initiatives to increase the rate of statin administration to this at-risk population.
Taken in combination, aspirin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins (combination pharmacotherapy) greatly reduce cardiac events. These therapies are underused, even among patients with drug insurance. Out-of-pocket spending is a key barrier to adherence. We estimated the impact of providing combination pharmacotherapy without cost sharing ("full coverage") to insured patients after a myocardial infarction (MI). Under base-case assumptions, compared to standard coverage, three years of full coverage will reduce mortality and reinfarction rates and will save 5,974 per patient. Our analysis suggests that covering combination therapy for such patients will save both lives and money.
BACKGROUND: Medication errors occur frequently, and poor medication labeling is cited as a potential cause. We assessed the format, content, and variability of prescription drug container labels dispensed in the community. METHODS: Identically written prescriptions for 4 commonly used medications (atorvastatin calcium [Lipitor], alendronate sodium [Fosamax], trimethoprim-sulfamethoxazole [Bactrim], and ibuprofen) were filled in 6 pharmacies (the 2 largest chains, 2 grocery stores, and 2 independent pharmacies) in 4 cities (Boston, Chicago, Los Angeles, and Austin [Texas]). Characteristics of the format and content of the main container label and auxiliary stickers were evaluated. Labels were coded independently by 2 abstractors, and differences were reconciled by consensus. RESULTS: We evaluated 85 labels after excluding 11 ibuprofen prescriptions that were filled with over-the-counter containers that lacked labels printed at the pharmacy. The pharmacy name or logo was the most prominent item on 71 (84%) of the labels, with a mean font size of 13.6 point. Font sizes were smaller for medication instructions (9.3 point), medication name (8.9 point), and warning and instruction stickers (6.5 point). Color, boldfacing, and highlighting were most often used to identify the pharmacy and items most useful to pharmacists. While the content of the main label was generally consistent, there was substantial variability in the content of instruction and warning stickers from different pharmacies, and independent pharmacies were less likely to use such stickers (P < .001). None of the ibuprofen containers were delivered with Food and Drug Administration-approved medication guides, as required by law. CONCLUSIONS: The format of most container labels emphasizes pharmacy characteristics and items frequently used by pharmacists rather than use instructions or medication warnings. The content of warning and instruction stickers is highly variable depending on the pharmacy selected.
OBJECTIVES: To quantify the influence of physicians' experiences of adverse events in patients with atrial fibrillation who were taking warfarin. DESIGN: Population based, matched pair before and after analysis. SETTING: Database study in Ontario, Canada. PARTICIPANTS: The physicians of patients with atrial fibrillation admitted to hospital for adverse events (major haemorrhage while taking warfarin and thromboembolic strokes while not taking warfarin). Pairs of other patients with atrial fibrillation treated by the same physicians were selected. MAIN OUTCOME MEASURES: Odds of receiving warfarin by matched pairs of a given physician's patients (one treated after and one treated before the event) were compared, with adjustment for stroke and bleeding risk factors that might also influence warfarin use. The odds of prescriptions for angiotensin converting enzyme (ACE) inhibitor before and after the event was assessed as a neutral control. RESULTS: For the 530 physicians who had a patient with an adverse bleeding event (exposure) and who treated other patients with atrial fibrillation during the 90 days before and the 90 days after the exposure, the odds of prescribing warfarin was 21% lower for patients after the exposure (adjusted odds ratio 0.79, 95% confidence interval 0.62 to 1.00). Greater reductions in warfarin prescribing were found in analyses with patients for whom more time had elapsed between the physician's exposure and the patient's treatment. There were no significant changes in warfarin prescribing after a physician had a patient who had a stroke while not on warfarin or in the prescribing of ACE inhibitors by physicians who had patients with either bleeding events or strokes. CONCLUSIONS: A physician's experience with bleeding events associated with warfarin can influence prescribing warfarin. Adverse events that are possibly associated with underuse of warfarin may not affect subsequent prescribing.
Decreasing HRT use among postmenopausal women may have a reciprocal impact on other osteoporosis therapy. Time series analysis of prescribing trends for millions of Medicaid beneficiaries revealed a 57% decline in HRT without augmenting the pace of bisphosphonate use. Prescribing changes dramatically increased Medicaid spending on osteoporosis therapy over the last decade and requires further evaluation of cost effectiveness. Introduction: Hormone replacement therapy (HRT) has been commonly prescribed to postmenopausal women, but its use is decreasing because adverse cardiac outcomes were reported by the Wome|$$|Aans Health Initiative (WHI) in July 2002. The reciprocal impact of the WHI on other osteoporosis medications use and expenditure is unknown. Materials and Methods: We conducted a time series analysis on prescription data from 50 state Medicaid programs between 1995 and 2004. Five medication categories were used: HRT, bisphosphonates, calcium, calcitonin, and raloxifene. Results: HRT was increasing before publication of the WHI, reaching 5 million prescriptions per year by mid-2002 (136 prescriptions per 1000 beneficiaries). Bisphosphonate prescribing rose in parallel until mid-2002. WHI publication was associated with a rapid reduction in HRT use, declining 57% by mid-2004 to an average of 59 prescriptions per 1000 beneficiaries (p = 0.01). WHI publication did not augment bisphosphonates' nearly linear rate of rise (p = 0.43) as their prescribing pace continued, whereas HRT declined. Medicaid spending on osteoporosis therapy also changed dramatically during the last decade, as yearly expenditure increased 664% from $1465 to $9742 per 1000 beneficiaries. Over this period, a significant shift from daily to weekly bisphosphonates also occurred. Conclusions: A dramatic decline in HRT and continued rise in bisphosphonate prescribing has occurred since the publication of the WHI. During this time, there have also been substantial increases in osteoporosis medication spending within Medicaid. Determining whether these trends are clinically appropriate and cost effective for osteoporosis therapy will have important implications for the development of future drug reimbursement programs, especially for elderly patients.
OBJECTIVES: Physicians may be aware of at least 2 types of costs when prescribing: patient's out-of-pocket costs and the actual costs of the medication. We evaluated physicians' perceptions about relevant costs for prescription drugs and the importance of communication about these costs. STUDY DESIGN: Mailed survey to a random sample of 1200 physician members of the California Medical Association, and a phone survey of a sample of nonresponders. METHODS: Descriptive statistics of survey items, McNemar's test to compare survey item responses, and logistic regression to evaluate the relationship between physician, practice, and system variables and physicians' perceptions of relevant medication costs. RESULTS: Of respondents with correct addresses, 49.6% responded to the survey; 13% of nonresponders were contacted by phone. Approximately 91% and 80% of physicians reported that it is important to manage patients' out-of-pocket costs and total medication costs, respectively. When comparing the relative importance of managing the 2 types of costs, 59% of physicians agreed that managing patients' out-of-pocket costs was more important than managing the total medication costs and only 16% disagreed. Physicians believed it was more important to discuss out-of-pocket costs than total costs with patients (P < .0001), but only 15% of physicians reported discussing out-of-pocket costs frequently and 5% reported talking about total medication costs frequently. Physicians who managed more Medicare patients had a greater likelihood than physicians managing fewer Medicare patients of prioritizing out-of-pocket cost rather than total cost management (P = .038), and generalists had a greater likelihood than medical subspecialists (P = .046). CONCLUSIONS: Physicians prioritize managing out-of-pocket costs over total medication costs. Pharmacy benefit designs that use patient out-of-pocket cost incentives to influence utilization are addressing the costs to which physicians may be most responsive. When physicians face conflicts between managing patients' out-of-pocket costs and total costs, they will likely try to protect the patients' resources at the expense of the insurer or society. Efforts to align patients', insurers', and societies' incentives will simplify prescribing decisions and result in better value in prescribing.
Background While the role of hydroxymethyl glutaryl coenzyme A reductase inhibitors (statins) in secondary prevention of cardiovascular (CV) events and mortality is established, their value for primary prevention is less clear. To clarify the role of statins for patients without CV disease, we performed a meta-analysis of randomized controlled trials (RCTs). Methods MEDLINE, EMBASE, Cochrane Collaboration, and American College of Physicians Journal Club databases were searched for RCTs published between 1966 and June 2005. We included RCTs with follow-up of 1 year or longer, more than 100 major CV events, and 80% or more of the population without CV disease. From each trial, demographic data, lipid profile, CV outcomes, mortality, and adverse outcomes were recorded. Summary relative risk (RR) ratios with 95% confidence intervals (CIs) were calculated using a random effects model. Results Seven trials with 42 848 patients were included. Ninety percent had no history of CV disease. Mean follow-up was 4.3 years. Statin therapy reduced the RR of major coronary events, major cerebrovascular events, and revascularizations by 29.2% (95% CI, 16.7%-39.8%) (P<.001), 14.4% (95% CI, 2.8%-24.6%) (P = .02), and 33.8% (95% CI, 19.6%-45.5%) (P<.001), respectively. Statins produced a nonsignificant 22.6% RR reduction in coronary heart disease mortality (95% CI, 0.56-1.08) (P = .13). No significant reduction in overall mortality (RR, 0.92 [95% CI, 0.84-1.01]) (P = .09) or increases in cancer or levels of liver enzymes or creatine kinase were observed. Conclusion In patients without CV disease, statin therapy decreases the incidence of major coronary and cerebrovascular events and revascularizations but not coronary heart disease or overall mortality.
PURPOSE: The study investigated the determinants of warfarin use in patients with atrial fibrillation (AF). METHODS: We assembled a retrospective cohort of community-dwelling elderly patients (aged > or = 66 years) with AF using linked administrative databases. We identified the physicians responsible for the ambulatory care of these patients using physician service claims and compared patients who did and did not have an identifiable provider. For those patients with an identifiable provider, we assessed the association between patient, physician, and hospital factors and warfarin use. RESULTS: Our cohort consisted of 140,185 patients, of whom 116,200 (83%) had an identifiable cardiac provider. Patients without a provider were significantly more likely to have comorbid conditions that increase their risk of warfarin-associated bleeding. After adjustment for clinical factors, patients without a provider were significantly less likely to receive warfarin (odds ratio 0.37, 95% confidence interval: 0.36-0.38). Of patients with providers, 50,551 patients (43.5%) received warfarin within 180 days after hospital discharge. Warfarin use was positively associated with AF-associated stroke risk factors (eg, prior stroke, congestive heart failure) and negatively associated with warfarin-associated bleeding risk factors (eg, history of intracerebral hemorrhage). After controlling for patient and hospital factors, patients cared for by noncardiologist physicians with cardiology consultation were more likely to receive warfarin then patients treated in noncollaborative environments. CONCLUSIONS: Warfarin continues to be substantially underprescribed to patients who are at high risk for AF-associated cardioembolic stroke. Our findings highlight the need for targeted quality improvement interventions and suggest preferred models of AF care involving routine collaboration between cardiologists and other physicians.
OBJECTIVE: To determine whether phlebotomy contributes to changes in hemoglobin and hematocrit levels in hospitalized general internal medicine patients. DESIGN: Retrospective cohort study. SETTING: General internal medicine inpatient service at a tertiary care hospital. PARTICIPANTS: All adult patients discharged from the Toronto General Hospital's internal medicine service between January 1 and June 30, 2001. A total of 989 hospitalizations were reviewed and 404 hospitalizations were included in our analysis. MEASUREMENTS AND MAIN RESULTS: Mean (SD) hemoglobin and hematocrit changes during hospitalization were 7.9 (12.6) g/L (P<.0001) and 2.1% (3.8%) (P<.0001), respectively. The mean (SD) volume of phlebotomy during hospital stay was 74.6 (52.1) mL. On univariate analysis, changes in hemoglobin and hematocrit were predicted by the volume of phlebotomy, length of hospital stay, admission hemoglobin/hematocrit value, age, Charlson comorbidity index, and admission intravascular volume status. The volume of phlebotomy remained a strong predictor of drop in hemoglobin and hematocrit after adjusting for other predictors using multivariate analysis (P<.0001). On average, every 100 mL of phlebotomy was associated with a decrease in hemoglobin and hematocrit of 7.0 g/L and 1.9%, respectively. CONCLUSIONS: Phlebotomy is highly associated with changes in hemoglobin and hematocrit levels for patients admitted to an internal medicine service and can contribute to anemia. This anemia, in turn, may have significant consequences, especially for patients with cardiorespiratory diseases. Knowing the expected changes in hemoglobin and hematocrit due to diagnostic phlebotomy will help guide when to investigate anemia in hospitalized patients.
PURPOSE: Patients with unstable angina or non-ST-segment elevation myocardial infarction (MI) may be managed with either an "invasive" or "conservative" strategy. It is unclear which of these strategies is superior. METHODS: We identified studies with MEDLINE and EMBASE searches (1966-September 2003) and by reviewing reference lists. Studies were included if they were randomized controlled trials comparing management strategies for patients in the early post-unstable angina/non-ST-segment elevation MI period and had follow-up data for at least 3 months. RESULTS: Seven trials that randomized a total of 9212 patients were included. The pooled odds ratio (OR) for all-cause mortality was 0.96 (95% confidence interval [CI]: 0.72 to 1.27). The occurrence of fatal or nonfatal re-infarction was reduced with an invasive strategy (OR 0.73; 95% CI: 0.61 to 0.88) as was readmission to hospital (OR 0.67; 95% CI: 0.48 to 0.94). The endpoints of nonfatal MI and the composite of death or nonfatal MI showed nonsignificant trends favoring an invasive strategy. Trials that included a higher proportion of patients with ST-segment depression on admission and trials in which a larger proportion of patients underwent revascularization showed a greater magnitude of benefit for an invasive strategy. CONCLUSION: For patients with unstable angina/non-ST-segment elevation MI, an invasive strategy reduces rates of fatal or nonfatal re-infarction and hospital readmission, but not all-cause mortality, when compared with a noninvasive strategy. These results suggest that an invasive management strategy should be considered for all patients with unstable angina/non-ST-segment elevation MI and perhaps in particular those with ST-segment depression.
In late 2004, the British government decided to allow a lipid-lowering agent to be sold as an over-the-counter medication. In contrast, the U.S. Food and Drug Administration recently decided not to do so. The United States and other countries will soon face similar decisions for other statins. Although statins have infrequent side effects and have been shown to be effective in moderate-risk primary prevention populations, many questions remain unanswered about their effectiveness at lower doses in over-the-counter use, the ability of patients to self-select themselves for appropriate therapy, and the social and economic implications associated with this method of distribution for preventive medications. A rational policy decision concerning over-the-counter statin use will require an effectiveness trial to provide data on how such drugs would be used in this context, as well as on the clinical outcomes that could be expected from this novel "route of administration."
U.S. health care has long featured a struggle between regulation and markets as vehicles of reform, and the community hospital is at the center of this struggle. The key to its financial viability is cross-subsidization, whereby revenues from insured patients subsidize the care of the uninsured and underinsured, and profits from well-compensated services support those operating at a loss. Cross-subsidization has been challenged by efforts to move highly compensated services and well-insured patients to ambulatory surgical centers and specialty hospitals. We review the ongoing battle between through a legal lens and offer conjectures about the outcome. Refined certificate-of-need regulation may be the preferable policy choice.
BACKGROUND: Physicians with more experience are generally believed to have accumulated knowledge and skills during years in practice and therefore to deliver high-quality care. However, evidence suggests that there is an inverse relationship between the number of years that a physician has been in practice and the quality of care that the physician provides. PURPOSE: To systematically review studies relating medical knowledge and health care quality to years in practice and physician age. DATA SOURCES: English-language articles in MEDLINE from 1966 to June 2004 and reference lists of retrieved articles. STUDY SELECTION: Studies that provided empirical results about knowledge or a quality-of-care outcome and included years since graduation or physician age as explanatory variables. DATA EXTRACTION: We categorized studies on the basis of the nature of the association between years in practice or age and performance. DATA SYNTHESIS: Overall, 32 of the 62 (52%) evaluations reported decreasing performance with increasing years in practice for all outcomes assessed; 13 (21%) reported decreasing performance with increasing experience for some outcomes but no association for others; 2 (3%) reported that performance initially increased with increasing experience, peaked, and then decreased (concave relationship); 13 (21%) reported no association; 1 (2%) reported increasing performance with increasing years in practice for some outcomes but no association for others; and 1 (2%) reported increasing performance with increasing years in practice for all outcomes. Results did not change substantially when the analysis was restricted to studies that used the most objective outcome measures. LIMITATIONS: Because of the lack of reliable search terms for physician experience, reports that provided relevant data may have been missed. CONCLUSIONS: Physicians who have been in practice longer may be at risk for providing lower-quality care. Therefore, this subgroup of physicians may need quality improvement interventions.
OBJECTIVE: Meta-analytic techniques are used to combine the results of different studies that have evaluated the accuracy of a given diagnostic test. The techniques commonly generate values that either describe the performance of a particular test or compare the discriminative ability of two tests. The later has received very little attention in the literature, and is the focus of this article. STUDY DESIGN AND SETTING: We summarize existing methods based on an odds ratio (OR) and propose a novel technique for conducting such analysis, the conditional relative odds ratio (CROR). We demonstrate how to extract the required data and calculate several different comparative indexes using a hypothetic example. RESULTS: A paired analysis is preferred to decrease selection bias and increase statistical power. There is no standard method of obtaining the standard error (SE) of each relative OR; thus, the SE of the summary index might be underestimated under the assumption of no within-study variability. CONCLUSION: The CROR method estimates less biased indexes with SEs, and conditioned on discordant results, it is much less problematic ethically and economically. However, small cell counts may lead to larger SEs, and it might be impossible to construct McNemar's 2 x 2 tables for some studies.
Patients who sustain a cardiac arrest have a less than 20% chance of surviving to hospital discharge. Patients may request do-not-resuscitate (DNR) orders if they believe that their chances for a meaningful recovery after cardiopulmonary arrest are low. However, in some identifiable circumstances, cardiopulmonary resuscitation (CPR) has a higher chance of success and lower likelihood of neurologic impairment. The probability of survival from a cardiac arrest influences patients' wishes regarding resuscitation; thus, when CPR has a higher likelihood of success, patients' expressed preferences for treatment as contained within a DNR order may not accurately reflect their intended goals. Patients should be offered the option of consenting to CPR for "higher-success" situations, including a witnessed cardiopulmonary arrest in which the initial cardiac rhythm is ventricular tachycardia or fibrillation, cardiac arrest in the operating room, and cardiac arrest resulting from a readily identifiable iatrogenic cause. This new level of resuscitation could be called a "limited aggressive therapy" order.
CONTEXT: Increasing contact has been reported between physicians and the pharmaceutical industry, although no data exist in the literature regarding potential financial conflicts of interest for authors of clinical practice guidelines (CPGs). These interactions may be particularly relevant since CPGs are designed to influence the practice of a large number of physicians. OBJECTIVE: To quantify the extent and nature of interactions between authors of CPGs and the pharmaceutical industry. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional survey of 192 authors of 44 CPGs endorsed by North American and European societies on common adult diseases published between 1991 and July 1999. One hundred authors (52%) provided usable responses representing 37 of 44 different CPGs that we identified. MAIN OUTCOME MEASURES: Nature and extent of interactions of authors with drug manufacturers; disclosure of relationships in published guidelines; prior discussion among authors regarding relationships; beliefs regarding whether authors' own relationships or those of their colleagues influenced treatment recommendations in guidelines. RESULTS: Eighty-seven percent of authors had some form of interaction with the pharmaceutical industry. Fifty-eight percent had received financial support to perform research and 38% had served as employees or consultants for a pharmaceutical company. On average, CPG authors interacted with 10.5 different companies. Overall, an average of 81% (95% confidence interval, 70%-92%) of authors per CPG had interactions. Similarly, all of the CPGs for 7 of the 10 diseases included in our study had at least 1 author who had some interaction. Fifty-nine percent had relationships with companies whose drugs were considered in the guideline they authored, and of these authors, 96% had relationships that predated the guideline creation process. Fifty-five percent of respondents indicated that the guideline process with which they were involved had no formal process for declaring these relationships. In published versions of the CPGs, specific declarations regarding the personal financial interactions of individual authors with the pharmaceutical industry were made in only 2 cases. Seven percent thought that their own relationships with the pharmaceutical industry influenced the recommendations and 19% thought that their coauthors' recommendations were influenced by their relationships. CONCLUSIONS: Although the response rate for this survey was low, there appears to be considerable interaction between CPG authors and the pharmaceutical industry. Our study highlights the need for appropriate disclosure of financial conflicts of interest for authors of CPGs and a formal process for discussing these conflicts prior to CPG development.