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.