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Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a "fair" price; these views were less demanding than those of non-US subjects in other studies. However, our participants' views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. [ABSTRACT FROM AUTHOR]

Conflicts between physicians and families about end-of-life decisions create challenging and emotionally difficult situations. In this article, we propose a "differential diagnosis" of such conflicts, distinguishing and describing the characteristics of families, physicians, and organizations and society that contribute to the "etiology" of the situation, as well as strategies for "diagnosing" the dominant factors. As a medical model, the differential diagnosis can be a useful tool to help physicians understand and manage conflicts about end-of-life care. [ABSTRACT FROM AUTHOR]

Objective: To assess the effects of a multimedia educational intervention about advance directives (ADs) and cardiopulmonary resuscitation (CPR) on the knowledge, attitude and activity toward ADs and life-sustaining treatments of elderly veterans.Design: Prospective randomized controlled, single blind study of educational interventions.Setting: General medicine clinic of a university-affiliated Veterans Affairs Medical Center (VAMC).Participants: One hundred seventeen Veterans, 70 years of age or older, deemed able to make medical care decisions.Intervention: The control group (n = 55) received a handout about ADs in use at the VAMC. The experimental group (n = 62) received the same handout, with an additional handout describing procedural aspects and outcomes of CPR, and they watched a videotape about ADs.Measurements and Main Results: Patients' attitudes and actions toward ADs, CPR and life-sustaining treatments were recorded before the intervention, after it, and 2 to 4 weeks after the intervention through self-administered questionnaires. Only 27.8% of subjects stated that they knew what an AD is in the preintervention questionnaire. This proportion improved in both the experimental and control (87.2% experimental, 52.5% control) subject groups, but stated knowledge of what an AD is was higher in the experimental group (odds ratio = 6.18, p <.001) and this effect, although diminished, persisted in the follow-up questionnaire (OR = 3.92, p =. 003). Prior to any intervention, 15% of subjects correctly estimated the likelihood of survival after CPR. This improved after the intervention in the experimental group (OR = 4.27, p =.004), but did not persist at follow-up. In the postintervention questionnaire, few subjects in either group stated that they discussed CPR or ADs with their physician on that day (OR = 0.97, p = NS).Conclusion: We developed a convenient means of educating elderly male patients regarding CPR and advance directives that improved short-term knowledge but did not stimulate advance care planning. [ABSTRACT FROM AUTHOR]

Objective: To develop a reliable measure of physician attitudes postulated to influence resource utilization.Design: Statements related to attitudes that may influence resource use were culled from the literature and informal discussions with physicians.Setting: Academic medical center.Participants: All faculty and housestaff in internal medicine, pediatrics, family medicine, and surgery at an academic medical center were surveyed. The response rate was 59% (n = 428).Results: Exploratory factor analysis of all internal medicine surveys revealed four prominent domains. These closely corresponded with our a-priori hypothesized domains and were interpreted as cost-consciousness, discomfort with uncertainty, fear of malpractice, and annoyance with utilization review. A replication of the analysis using 25 survey items and conducted on the remainder of the data (surgeons, pediatricians, and family practitioners) revealed a similar four-factor solution. Scales were constructed for each of the four domains. Cronbach's alpha ranged from 0.66 to 0.88. Discomfort from uncertainty and fear of malpractice were moderately correlated (r = 0.42); other scale-scale correlations were modest. Of the four attitude measures, only cost-consciousness was associated with lower self-estimates of resource use. Both annoyance with utilization review and fear of malpractice increased as the proportion of time spent in patient care increased.Conclusions: Although various physician attitudes and beliefs have been hypothesized to influence health services resource use, reliable and valid measures for most of these have not been developed. The authors developed a 19-item survey instrument designed to measure these attitudes reliably. The four scales developed in this study may help identify physician attitudes that are important determinants of physician decision making and help foster a better understanding of physicians' reactions and acculturation to different practice environments. [ABSTRACT FROM AUTHOR]

Reviews the fourth edition of the American College of Physicians Ethics Manual. Role of the professional society in promulgating an ethics code; Examination of the formal field of bioethics in historical context; How ethics codes are regarded by those outside of the medical profession.