Subjects' views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study.

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.

Measuring patient expectations: does the instrument affect satisfaction or expectations?

BACKGROUND: Fulfillment of patients' expectations may influence health care utilization, affect patient satisfaction, and be used to indicate quality of care. Several different instruments have been used to measure expectations, yet little is known about how different assessment methods affect outcomes. OBJECTIVE: The object of the study was to determine whether different measurement instruments elicit different numbers and types of expectations and different levels of patient satisfaction. DESIGN: Patients waiting to see their physician were randomly assigned to receive 1 of 2 commonly used instruments assessing expectations or were assigned to a third (control) group that was not asked about expectations. After the visit, patients in all 3 groups were asked about their satisfaction and services they received. SUBJECTS: The study subjects were 290 male, primary care outpatients in a VA general medicine clinic. MEASURES: A "short" instrument asked about 3 general expectations for tests, referrals, and new medications, while a "long" instrument nested similar questions within a more detailed list. Wording also differed between the 2 instruments. The short instrument asked patients what they wanted; the long instrument asked patients what they thought was necessary for the physician to do. Satisfaction was measured with a visit-specific questionnaire and a more general assessment of physician interpersonal skills. RESULTS: Patients receiving the long instrument were more likely to express expectations for tests (83% vs. 28%, P <0.001), referrals (40% vs. 18%, P <0.001), and new medications (45% vs. 28%, P <0.001). The groups differed in the number of unmet expectations: 40% of the long instrument group reported at least 1 unmet expectation compared with 19% of the short instrument group (P <0.001). Satisfaction was similar among the 3 groups. CONCLUSIONS: These different instruments elicit different numbers of expectations but do not affect patient satisfaction.

Trust and the ethics of health care institutions.

Though trust is essential to relationships between people, including that between patient and clinician, its role in organizational ethics is largely unexplored. Nonetheless, trust is also ideally a part of the relationship between patient and health care institution, both because it is desirable in and of itself, and because it makes for better medical care.

Conflicts regarding decisions to limit treatment: a differential diagnosis.

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.

Maintaining trust in the surgeon-patient relationship: challenges for the new millennium.

Changes in the structure of the health care system have placed unprecedented stress on the surgeon-patient relationship. The essential trust placed in the surgeon by her patients has been weakened by changes in the structure and financing of the health care system. This article considers the historical and ethical foundation of the surgeon-patient relationship and proposes that the primary moral obligation of surgeons is to strengthen and earn patient trust. By improving communication skills, enhancing ethical education, serving as consistent advocates for patients, and conducting patient-focused outcome research, the surgical community can meet its moral obligation by increasing trust in the surgeon-patient relationship.

A multimedia intervention on cardiopulmonary resuscitation and advance directives.

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.

Normative issues in cost effectiveness analysis.

Cost effectiveness analysis (CEA) and cost-utility analysis are increasingly used to compare competing uses for limited health care resources, informing policy decisions at governmental, payer, and clinical levels of the health system. The authors discuss various methodologic choices in CEA and the normative (value) assumptions and implications of those choices. The treatment of adult onset diabetes is used as a simplified case example to illustrate the choice of perspective, cost inclusion and exclusion, benefit measurement and aggregation, and how these and other aspects of CEA can implicitly influence policy decisions with consequences for individuals and groups. CEA can be a valuable source of information, but it is a poor "technologic fix" for the thorny problem of allocating limited health care resources.

Money and trust: relationships between patients, physicians, and health plans.

In response to three articles on managed care by Allen Buchanan, David Mechanic, and Ezekiel Emanual and Lee Goldman (this issue), I discuss doctor-patient and organization-member trust and the moral obligations of those relationships. Trust in managed care organizations (providers of and payers for health care) stands in stark contrast to the current contractual model of health insurance purchase, but is more coherent with consumer expectations and with the provider role of such organizations. Such trust is likely to differ from that between doctors and patients. Financial reimbursement systems for physicians, one example of organizational change in our health system, can be evaluated for their impact on both kinds of trust according to their intrusiveness, openness, and goals. Although involving managed care enrollees in value-laden decisions that affect them is commendable, restrictions on or regulation of physician incentive systems may be better accomplished on a national level.

Allocating health care: cost-utility analysis, informed democratic decision making, or the veil of ignorance?

Assuming that rationing health care is unavoidable, and that it requires moral reasoning, how should we allocate limited health care resources? This question is difficult because our pluralistic, liberal society has no consensus on a conception of distributive justice. In this article I focus on an alternative: Who shall decide how to ration health care, and how shall this be done to respect autonomy, pluralism, liberalism, and fairness? I explore three processes for making rationing decisions: cost-utility analysis, informed democratic decision making, and applications of the veil of ignorance. I evaluate these processes as examples of procedural justice, assuming that there is no outcome considered the most just. I use consent as a criterion to judge competing processes so that rationing decisions are, to some extent, self-imposed. I also examine the processes' feasibility in our current health care system. Cost-utility analysis does not meet criteria for actual or presumed consent, even if costs and health-related utility could be measured perfectly. Existing structures of government cannot creditably assimilate the information required for sound rationing decisions, and grassroots efforts are not representative. Applications of the veil of ignorance are more useful for identifying principles relevant to health care rationing than for making concrete rationing decisions. I outline a process of decision making, specifically for health care, that relies on substantive, selected representation, respects pluralism, liberalism, and deliberative democracy, and could be implemented at the community or organizational level.

Measuring physician attitudes toward cost, uncertainty, malpractice, and utilization review.

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.

Discussions about limiting treatment in a geriatric clinic.

OBJECTIVE: Obtain detailed information about the frequency and content of discussions about withholding treatment between doctors and elderly outpatients. DESIGN: Survey. SETTING: Primary care geriatric clinic at an urban university. PARTICIPANTS: Twelve physicians and one nurse practitioner completed questionnaires for 185/198 (93.4%) patient visits. MEASUREMENTS: Questionnaires were completed by physicians after each patient visit during August 1989. Interviews were conducted with physicians who had discussed limiting life-sustaining treatment with patients. RESULTS: Ten percent (n = 19) of patients seen had had discussions with their physicians about life-sustaining treatment. These patients were older and had worse prognoses as estimated by their physicians. Physicians usually raised the issue with the families of demented patients and mentioned dementia, quality of life, prognosis, and the need to make other clinical decisions as motivation for initiating discussions. The majority of patients with poor prognoses, however, had not had discussions about life support. CONCLUSIONS: Despite increasing attention given to end-of-life decisions in the medical and lay press, discussions with elderly outpatients about limiting treatment occur rarely. They are more likely when patients are older or have worse prognoses, but age, prognosis, and poor quality of life do not consistently lead physicians to raise the issue.

Pneumocystis carinii infection presenting as necrotizing thyroiditis and hypothyroidism.

Extrapulmonary Pneumocystis infection has been increasingly reported in patients with acquired immune deficiency syndrome (AIDS), in particular, recently in association with the increasing use of aerosolized pentamidine. This report describes the unusual presentation of extrapulmonary Pneumocystis infection as a thyroid neck mass and clinical hypothyroidism in a 37-year-old man with hemophilia and AIDS. This case differs from the previously reported single case of isolated thyroid pneumocystosis in the presence of a rapidly enlarging neck mass, lack of previous Pneumocystis, and prior prophylaxis with aerosolized pentamidine. The pathologic and electron microscopic description of the peculiar flocculent necrotic thyroid material is contrasted with typical pulmonary alveolar findings in Pneumocystis pneumonia (PCP), the differential diagnoses of a rapidly expanding neck mass, and diagnostic difficulties of hypothyroidism in patients with AIDS are discussed. Finally, it is emphasized that use of aerosolized pentamidine, although successful for prevention of pulmonary PCP, may be insufficient to prevent extrapulmonary infection.