Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in Western Kenya.

OBJECTIVES: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or "what is fair" for study participants in an HIV/AIDS clinical drug trial. DESIGN: Qualitative study with focus groups. SETTING: Teaching and referral hospital and rural health centre in Western Kenya. PARTICIPANTS: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. RESULTS: Eighty nine individuals participated in a total of 11 focus groups over a four month period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidizing of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants. CONCLUSIONS: Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants.

Racial disparity in cardiac decision making: results from patient focus groups.

BACKGROUND: While numerous studies suggest that African Americans receive fewer invasive cardiac procedures than whites, the basis for these treatment differences is not understood. METHODS: We conducted focus group sessions with patients who had received treatment in the hospital or the emergency department within the preceding 3 months for ischemic heart disease at 2 urban, university-affiliated hospitals. RESULTS: Discussions with patients identified the following factors that influenced their decision making: clarity, simplicity, and consistency of treatment recommendations; advice from friends and family about whether to accept recommendations; availability to speak with others who accepted similar recommendations; and having honest and caring physicians. African American patients identified the following additional factors that influenced their decision making: perceptions of health care discrimination; perceptions of undesirable physician behavior; faith in God to control one's destiny; and patient-physician camaraderie. CONCLUSIONS: Participants identified common issues influencing health care decision making, regardless of race. However, additional factors were expressed only by African American participants. These factors conveyed racial differences in perceptions of the health care system that may, in part, contribute to differences in health care decision making and treatment.

Can raters consistently evaluate the content of focus groups?

Focus groups are increasingly being used to provide insights to researchers and policy makers. These data complement quantitative approaches to understanding the world. Unfortunately, quantitative and qualitative methodologies have often been viewed as antithetical, rather than complementary, strategies. While focus groups can clearly generate rich information that is unobtainable through other quantitative methods, it is important to determine the degree to which different raters can consistently extract information from transcripts. Thus, our goal was to quantify agreement in the interpretation of transcripts from patient and physician focus groups, using decision-making in ischemic heart disease as a model. We used data from focus groups with both patients and physicians that sought to identify factors affecting diagnostic and treatment decisions in ischemic heart disease. Three raters independently reviewed transcribed audiotapes from focus groups of patients with ischemic heart disease, as well as focus groups of physicians who care for these patients. We found that raters could not distinguish between major and minor factors reliably. More troubling, however, is that consistency regarding the apparently straightforward judgment as to the mere presence or absence of a factor was difficult to achieve. In particular, the three raters of each transcript failed to agree on between one third and one half of the factors. This reasonably high level of disagreement occurred despite the raters: (1) having generated the individual factors themselves based upon their reading a random sample of actual transcripts and (2) being trained in the use of rating forms (including standard definitions of themes). These data suggest that if a single rater evaluates focus group transcripts, as is commonly done, judgments may not be reproducible by other raters. Moreover, a single rater may not extract all important information contained in the transcripts.

Further evaluation of the effects of 7.5% sodium chloride/6% Dextran-70 (HSD) administration on coagulation and platelet aggregation in hemorrhaged and euvolemic swine.

In previous studies, we determined that incubation of high concentrations of the 7.5% saline (HS) component of HSD with human blood, in vitro, significantly prolonged prothrombin time (PT), and reduced platelet aggregation. Considering the rapid plasma volume expansion following HSD infusion, the present study tested the hypothesis that any HS-induced effects on coagulation would have no clinical significance when HSD was infused for the treatment of hemorrhagic hypotension. Conscious, splenectomized pigs, either euvolemic (n = 11) or bled 27 ml/kg over 60 min (n = 9), were treated with the proposed therapeutic dose of 4 ml/kg HSD. Blood samples were withdrawn prior to and at the end of the hemorrhage and 0.5, 1, 2, 3, 4, 24, 48, 72, and 168 hr following HSD infusion, and PT, activated partial thromboplastin time (APTT), and platelet aggregation were determined. HSD did not significantly affect PT, APTT, or platelet aggregation in either group of swine at any time measured. In other studies, HSD did not prolong bleeding times after 1 or 2 hr in euvolemic pigs. These data further support the premise that a single dose of HSD for the prehospital treatment of hemorrhagic hypotension will not adversely affect blood coagulation.

Jehovah's Witnesses and blood transfusion: physicians' attitudes and legal precedents.

Patients with significant medical problems who refuse some aspects of their medical care present medicolegal and management problems for their physicians. The selective refusal of transfusion of blood products by Jehovah's Witnesses typifies such situations. To explore physicians' reactions to these constraints, we sent a questionnaire to medical students, residents, and faculty wherein we asked them to respond to case simulations involving Jehovah's Witnesses and refusal of transfusion. Fifty percent of all respondents, including 84% of the faculty, reported experience in dealing with Jehovah's Witnesses. Overall, respondents were more likely to give transfusion to an infant or an incompetent adult than to competent adults. Only educational level made a significant difference in response: faculty members most frequently mentioned obtaining a court order when giving transfusion against a patient's will. Case law, upon which legal grounds such decisions stand, is often conflicting and is evolving toward allowing patients a freer hand in their choices of therapy. We sketch the history and present status of these precedents and offer a framework for dealing with patients' refusal of care.

The development of physician norms in the United States. The treatment of Jehovah's Witness patients.

According to their religious dogma, Jehovah's Witnesses (JW) are unwilling to accept blood transfusions, even if their own lives are at stake. This belief puts physicians, who have no consistent legal norms to guide their behavior, in an ambiguous situation. To examine the socialization process regarding the development of norms under legal uncertainty, we asked medical students, house staff and faculty physicians to discuss their actions regarding each of four case simulations (one minor child, one incompetent adult, and two competent adults). In our sample, 84% of faculty and half of the respondents overall report having had personal experience with JWs. Despite patient or parental requests to the contrary, physicians were most likey to transfuse the child (80%), followed by the imcompetent adult (63%) and the two competent adults (25 and 15%). This ordering reflects the consistency of court decisions. In addition, the physicians' decisions regarding whether or not to transfuse did not vary with either their experience with JWs or level of training; however, experienced physicians appeared to learn to take precautions to protect themselves and their hospital from legal action. The study also indicates lack of formal medical education as an information source from which medical students learn about this ethical problem.

KIE: A survey of medical students and physicians at Indiana University Medical Center regarding blood transfusions for Jehovah's Witnesses indicates that informal norms in the medical community parallel ambiguous legal norms. Transfusions are likely to be given, despite lack of consent, to children and incompetent adults. The wishes of competent adults are more generally respected. Physicians' decisions regarding transfusions are not affected by experience or level of training; however, experienced physicians are more likely to obtain a court order. Since ethical problems related to Jehovah's Witnesses are rarely considered during medical education, the authors emphasize the need to make physicians aware of nonmedical considerations in treatment decisions.

Compliance with medication regimens among chronically ill, inner city patients.

Patient adherence to medication regimens in explored as a function of (1) patient beliefs, perceptions, and knowledge of the illness, (2) extent of social support for health actions, (3) complexity of and specific knowledge about the regimen, and (4) satisfaction with clinical encounters and the health care facility. One hundred and ninety patients receiving care on an outpatient basis at a municipal teaching hospital were interviewed. The patients' medical records provided an additional data source. Path analysis generally supported the stated hypotheses. The only variables that had a significant effect opposite to that hypothesized were perceived severity about and susceptibility to the illness. The factors with the greatest predictive power in regard to patient compliance were (1) patients' ability to state the names of or accurately describe their medicines, (2) patients' ability to state the functions of their drugs, and (3) the complexity of the medication regimen as measured by the number of drugs prescribed for the patient.

Health beliefs and smoking behavior.

Smoking histories and beliefs about smoking were obtained on 120 ex- and current smokers. Ex-smokers view smoking as a serious health problem, did not report having a physician recommend they stop, and feel personally susceptible to its adverse effects. Moderate smokers (0-10/day) also view smoking as serious, but do not see themselves as vulnerable to its adverse effects. The data suggest that certain attitudes can discriminate between groups of current smokers, as well as smokers from ex-smokers.

Changing house staff attitudes toward nurse practitioners during their residency training.

This study examines the hypothesis that increased physician contact with nurse practitioners (NPs) during residency training would ecourage positive house staff attitudes. House staff expectations of and attitudes toward NPs were assessed at three points during the residency. Data indicated a more positive evaluation of NPs by house staff later in the residency program, as shown by: 1) physician expectations and valuation of NPs, 2) attitudes concerning future employment of NPs, and 3) the extent and capacity of NP utilization by residents.

Before renovation: 'fit' of environment to patients, staff studied.

Before undertaking a hospital or clinic renovation project, "expert" opinions are usually gathered from architects, administrators, trustees, etc., but what about the opinions of those who will be most directly affected--the staff and the patients? This article talks about a study, funded by the Regenstrief Institute, which investigated the benefits to be gained by asking questions of that often-ignored group.