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.
OBJECTIVE: To review evidence as to the precision and accuracy of clinical examination for aortic regurgitation (AR). METHODS: We conducted a structured MEDLINE search of English-language articles (January 1966-July 1997), manually reviewed all reference lists of potentially relevant articles, and contacted authors of relevant studies for additional information. Each study (n = 16) was independently reviewed by both authors and graded for methodological quality. RESULTS: Most studies assessed cardiologists as examiners. Cardiologists' precision for detecting diastolic murmurs was moderate using audiotapes (kappa = 0.51) and was good in the clinical setting (simple agreement, 94%). The most useful finding for ruling in AR is the presence of an early diastolic murmur (positive likelihood ratio [LR], 8.8-32.0 [95% confidence interval [CI], 2.8-32 to 16-63] for detecting mild or greater AR and 4.0-8.3 [95% CI, 2.5-6.9 to 6.2-11] for detecting moderate or greater AR) (2 grade A studies). The most useful finding for ruling out AR is the absence of early diastolic murmur (negative LR, 0.2-0.3 [95% CI, 0.1-0.3 to 0.2-0.4) for mild or greater AR and 0.1 [95% CI, 0.0-0.3] for moderate or greater AR) (2 grade A studies). Except for a test evaluating the response to transient arterial occlusion (positive LR, 8.4 [95% CI, 1.3-81.0]; negative LR, 0.3 [95% CI, 0.1-0.8]), most signs display poor sensitivity and specificity for AR. CONCLUSION: Clinical examination by cardiologists is accurate for detecting AR, but not enough is known about the examinations of less-expert clinicians.
The authors evaluated the accuracy of clinical impressions and Mini-Mental State Exam scores for assessing patient capacity to consent to major medical treatment, relative to expert psychiatric assessment. Consecutive medical inpatients (N = 63) facing a decision about major medical treatment received a clinical impression of capacity from their treating physician and the Standardized Mini-Mental State Exam (SMMSE); 48 received independent psychiatric assessment of capacity. Analyses revealed that both clinical impressions and SMMSE scores were generally inaccurate in determining capacity, although all 23 participants with a clinical impression of "definitely capable" were found capable by the psychiatrist. Given the importance of assessing capacity to consent to major medical treatment, better approaches to the clinical assessment of capacity are required. Several strategies are discussed.
OBJECTIVES: To examine funding priorities assigned by health ministry officials when choosing between clinical programs that offer similar overall benefits distributed in different ways (e.g. large gains for a few versus small gains for many), and to compare the relative magnitude of any distributional bias to age biases. METHODS: A survey consisting of paired hypothetical health care programs was mailed to the 135 most senior officials of the Health Ministry in Ontario, Canada (population 11.5 million). Respondents were asked to assume they were members of a panel allocating a fixed sum of money to one of two programs in each pair. All program descriptions included the number of persons affected each year by a given disease and the average survival gains from the hypothetical programs. Some scenarios also mentioned the side-effects associated with programs and/or the average age of the beneficiaries. RESULTS: Four respondents had retired/died. Of 131 eligible respondents, 80/131 (61%) provided usable responses. Asked to choose between providing large benefits to a few citizens and small benefits to a great many, 23% (95% CI: 14%, 33%) of respondents were unable to decide, but 55.8% (95% CI: 47%, 70%) favored providing large benefits to fewer patients. Eliminating the 23% unable to decide, 47/62 or 76% (CI 63%, 86% expressed a distributional preference. With a smaller distributional discrepancy, indecision increased, with 35% of respondents having no preference and the remainder split almost evenly between the two programs. Other scenarios showed that health officials' pro-youth biases were only slightly larger than their distributional preferences and that distributional preferences were magnified when combined with minor differences in average ages of beneficiaries. CONCLUSIONS: A substantial minority of health care decision-makers had difficulty choosing between programs with similar overall gains and distributional differences--a result consistent with the utilitarian assumptions of cost-effectiveness analysis. However, when distributional differences were large, decision-makers clearly favored large gains for a few beneficiaries rather than small gains for many. Policy analysts should explicitly weigh distributional issues along with aggregate health gains when addressing resources allocation problems.
OBJECTIVE: To determine the value of conjunctival pallor in ruling in or ruling out the presence of severe anemia (hemoglobin < or = 90 g/L) and to determine the interobserver agreement in assessing this sign. DESIGN: Patients were prospectively assessed for pallor by at least one of three observers. All observations were made without information of the patient's hemoglobin value or of another observer's assessment. SETTING: Tertiary-care, university-affiliated teaching hospital. PATIENTS: Three hundred and two medical and surgical inpatients. MEASUREMENTS AND MAIN RESULTS: Likelihood ratios (LRs) calculated for conjunctival pallor present, borderline, and absent were as follows: pallor present, LR 4.49 (95% confidence interval [CI] 1.80, 10.99); pallor borderline, LR 1.80 (95% CI 1.18, 2.62); pallor absent, LR 0.61 (95% CI 0.44, 0.80). Kappa scores of interobserver agreement between paired observers were 0.75 and 0.54. CONCLUSIONS: The presence of conjunctival pallor, without other information suggesting anemia, is reason enough to perform a hemoglobin determination. The absence of conjunctival pallor is not likely to be of use in ruling out severe anemia. With well-defined criteria, interobserver agreement is good to very good.
The population-based dialysis rate in Ontario more than doubled between 1981 and 1992; yet there is concern about over-loaded facilities, delayed treatment and denial of dialysis through nonreferral and implicit rationing. A working party involving several stakeholders has been established in Ontario to address these issues. However, clinical policy making concerning dialysis services is impeded in all provinces by a lack of information. The causes of the moderately large variations in dialysis rates from province to province remain unclear. The exact extent and risks of delayed therapy have not been well defined. Dialysis protocols vary inexplicably among centres, and cost data on different methods of providing dialysis are limited. Many steps could be taken in Ontario and other provinces to generate a better information base for planning and managing dialysis services. Predialysis clinics with outreach programs could help to ensure equitable access to this life-saving therapy. Criteria for choosing modes and intensities of renal-replacement therapy must be reviewed. In areas of clear disagreement and uncertainty, patients could be randomly assigned to different protocols and outcomes studied. In areas of agreement, the criteria should be standardized. Advance directives may help ascertain patients' wishes concerning the initiation or continuation of dialysis, and more accurate data on prognosis of different patient subgroups would aid in early identification of patients in a hopelessly deteriorating situation. Last, studies comparing the "output" (e.g., hours on hemodialysis) per dollar of different dialysis units and modalities are also needed to ensure that all facilities are opening efficiently without compromising patient outcomes.
OBJECTIVE: To describe the prevalence and content of long-term care facility policies regarding the use of life-sustaining treatments (cardiopulmonary resuscitation (CPR), artificial hydration and nutrition, dialysis, antibiotics for life-threatening infections, transfer to acute care hospital) and advance directives in Canada. DESIGN: Cross-sectional mailed survey. SETTING: Canadian long-term care facilities with 25 beds or more listed in the 1991-92 Directory of Long Term Care Centres in Canada. Institutions listed as, "general hospitals,""psychiatric hospitals,""children's treatment centres,""group homes," or as purely residential facilities were excluded. PARTICIPANTS: Chief Executive Officers or their designates. MAIN OUTCOME MEASURES: Respondents' self-reports regarding the existence of life-sustaining treatment or advance directive policies and content analysis of the policies themselves. RESULTS: Of 1472 long-term care facilities, 1021 (69%) responded. Of these, 344 (34%) institutions had 397 policies regarding the use of life-sustaining treatments or advance directives. Three hundred twenty facilities (31%) had 349 do-not-resuscitate (DNR) policies (40% on CPR alone and 60% on CPR plus other life-sustaining treatments). Seventeen institutions (2%) each had one policy addressing life-sustaining treatments other than CPR, and 31 institutions (3%) each had one policy addressing advance directives. Of the 397 policies, 171 (43%) required routine discussion with all patients, 156 (39%) mentioned futility, 331 (83%) indicated that the competent patient had the right to make a decision about life-sustaining treatment, 265 (67%) indicated that the family of the incompetent patient had this right, 27 policies (7%) mentioned conflict resolution, 378 (95%) had an explicit requirement for recording the decision, 10 (3%) required explicit communication of the decision to the competent patient, 10 (3%) required such communication to the family of the incompetent patient, 260 (66%) required updating of the decision, and 213 (54%) mentioned rescinding or changing the decision. CONCLUSIONS: Only one-third of Canadian long-term care facilities have do-not-resuscitate policies, and even fewer have policies on advance directives or life-sustaining treatments other than CPR. The policies themselves could be improved by encouraging routine advance discussions, scrutinizing the use of the futility standard, stipulating procedures for conflict resolution, and explicitly requiring communication of the decision to competent patients or substitute decision makers of incompetent patients.