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PubMed2005

Factors that influence women's decisions about whether to participate in research: an exploratory study.

BACKGROUND: Women are increasingly being asked to consider participating in medical research. We sought to investigate views of women who participated in and declined to participate in a study that was part of a program of maternity care research. METHODS: An exploratory study using focus group interviews and semistructured interviews was conducted. A purposive sample of 17 postnatal women who had participated in research, from a hospital in the North West of England, were interviewed. An open coding mechanism to identify emergent themes was used for the analysis of data. RESULTS: Of women who had not declined to participate in any research, the following themes were identified: altruism versus self-protection, enhanced versus inferior care, professional guidance versus self-direction, and welcome versus unacceptable methodology. Of women who had participated in some research but declined to participate in other research, the following themes were identified: feeling disempowered by the process, inability to believe equipoise existed, and practical inconvenience. CONCLUSIONS: These findings suggest that although health care researchers adopt an individualistic approach to care, they may fail to adopt a similar approach within research. What is important and acceptable to women needs to be ascertained to develop appropriate research strategies. This plan will ensure that research is carried out to the highest ethical standard, which may increase recruitment rates.

Clinical Trials as Topic↗

PubMed1991

Outcome of involuntary medication in a state hospital system.

OBJECTIVE: The purpose of the study was to examine the course of involuntarily administered medication in a state hospital population. METHOD: The authors retrospectively examined the records of all 51 involuntarily medicated patients in six state hospitals in New York City in a single calendar year. Clinical course was recorded for the period of involuntary medication and for 12 months thereafter. These patients were compared to 51 patients on the same wards who accepted medication. RESULTS: Clinicians assessed involuntarily medicated patients as more dangerous to themselves or others and less delusional after treatment than the comparison patients. Long-acting intramuscular antipsychotics were prescribed more frequently for involuntarily medicated patients. No differences were observed in rates of discharge, outpatient cooperation, or rehospitalization. Half of the patients in both groups remained continuously institutionalized, and of those who left the hospital, only 30% of the involuntarily medicated group and 40% of the comparison group took medication as outpatients. CONCLUSIONS: For these chronically severely ill patients, involuntary medication did not appear to enhance insight or cooperation or result in rapid return to the community. Involuntary medication is often a necessary short-term, in-hospital management strategy, but it does not replace the need to develop comprehensive, long-term inpatient and community-based approaches to the management of treatment refusal.

Adult↗

PubMed1995

Who cares about cost? Does economic analysis impose or reflect social values?

In a two-stage survey, a cross-section of Australians were questioned about the importance of costs in setting priorities in health care. Generally, respondents felt that it is unfair to discriminate against patients who happen to have a high cost illness and that costs should therefore not be a major factor in prioritising. The majority maintained this view even when confronted with its implications in terms of the total number of people who could be treated and their own chance of receiving treatment if they fall ill. Their position cannot be discarded as irrational, as it is consistent with a defensible view of utility. However, the results suggest that the concern with allocative efficiency, as usually envisaged by the economists, is not shared by the general public and that the cost-effectiveness approach to assigning priorities in health care may be imposing an excessively simple value system upon resource allocation decision-making.

Attitude to Health↗

PubMed2000

A prospective study of patient-physician communication about resuscitation.

OBJECTIVE: To evaluate prospectively seriously ill patients' characteristics, perceptions, and preferences associated with discussing resuscitation (CPR) with their physicians. DESIGN: Prospective cohort. SETTING: Five academic medical centers. PARTICIPANTS: Patients enrolled in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments who had not communicated with their physicians about CPR at admission to a hospital for life-threatening illness (n = 1288). MEASUREMENTS: Baseline surveys of patients' characteristics, health status, desires for participation in medical decision making, and cardiopulmonary resuscitation. Two month follow-up surveys of patients' communication of resuscitation preference. Chart reviews for clinical indicators. RESULTS: Thirty percent of patients communicated their resuscitation preference to their physician during a 2 month-period following hospital admission. Patients whose preference was to forego CPR (odds ratio (OR) 2.9;(95% CI, 1.9-4.2)) and whose preference had changed from desiring to foregoing CPR (OR 1.6; (95% CI, 1.1-2.4)) were more likely to communicate their preference than patients who continued to prefer to receive CPR. However, only 50% of patients who maintained a preference to forego CPR communicated this over a 2-month period. Having an advance directive and remaining in the hospital at 2-month follow-up were also independently associated with communication, whereas patients' preference for participation in decision-making, health status, and prognostic estimate were not. CONCLUSIONS: Communication about resuscitation preferences occurred infrequently after hospital admission for a serious illness, even among patients wishing to forego resuscitation. Factors such as declining quality of life, which were expected to be associated with communication, were not. An invitation to communicate about CPR preference is important after hospital admission for a serious illness. Novel approaches are needed to promote physician-patient discussions about resuscitation.

Aged↗

PubMed1989

Ethical conflict in the practice of occupational medicine.

The practice of occupational medicine has been portrayed as being fraught with ethical conflict and yet this problem has received little systematic study. A question and case study survey of a randomly selected cohort of members of the American Occupational Medical Association has been performed to examine the extent and nature of this problem in occupational medicine practice in the United States. The results indicate a strong reliance on traditional medical role models in responding to ethical conflict but with significant underlying tension between more deontological physician-patient approaches and more teleological public health approaches. These results have significant implications for the synthesis of bioethical theories based on a perceived complementarity of ethical reality, as well as suggesting important improvements in future occupational medicine training.

Adult↗

PubMed1994

A new perspective on threatened autonomy in elderly persons: the disempowering process.

This study explored factors other than medical condition and treatments which contributed to the discharge experiences of 12 rural and 9 urban patients. Interpretive research methodology included document review, observation and in-depth interviews of all key participants. The purposefully selected sample consisted of a total of 21 patients, 22 informal caregivers, and 117 professionals involved in the hospital and/or home setting. Findings document a new perspective on how patients and professionals together contribute to the patient's threatened autonomy. Lack of clarity about goals, aspirations, and purpose in life and a generally negative frame of mind in the elderly combine with professional practice approaches to create a disempowering process. Faced with the biomedical orientation and paternalism of professionals, patients with a positive mindset and sense of direction and purpose in life did not experience threat to their autonomy. The researchers conclude that empowerment strategies must encompass a patient-centred approach, which includes an understanding of the patient's mindset, goals, aspirations, and sense of purpose within a larger life context. This consideration is essential to enable elderly patients to maintain autonomy despite continued health care requirements.

Aged↗

PubMedDate not supplied

Ethical conflict in long-term care: is legislation the answer?

The Omnibus Budget Reconciliation Act of 1987 radically redefined the relationship between nursing facilities and their residents. To explore the impact of this autonomy-enhancing but controversial legislation on nursing operations in skilled nursing facilities, two focus groups were convened. Nurse administrators identified ways in which the recently implemented legislation facilitates or inhibits resolution of the ethical conflicts they face. Participants concluded that legislation alone was insufficient to create needed reform in long-term care and recommended a multifaceted approach. A model is presented for creating a community of caring that identifies regulatory reform, professional empowerment, and organizational redesign as catalysts for a change.

Adult↗

PubMedDate not supplied

A randomized trial using videotape to present consent information for colonoscopy.

A randomized controlled trial was conducted to determine if a videotaped presentation by a physician conveys information more effectively than an in-person discussion by the same physician using the identical script. Two hundred one patients undergoing colonoscopy were enrolled in the study. Patients were randomly assigned to one of three groups: video plus discussion, video alone, and discussion alone. A validated, 13-item knowledge test and the State-Trait Anxiety Inventory were administered to all patients. Mean number of correct test answers for video plus discussion was 11.04; for video alone, 10.70; and for discussion alone, 9.61. ANOVA with planned orthogonal comparisons showed that the patients in the two video groups had significantly better scores (p < 0.001) than those in the discussion-only group. No difference was noted between the two video groups (p = 0.32). Anxiety did not increase with increased understanding of the risks and benefits of colonoscopy. This approach may work as well for other invasive medical procedures and could save physician time while laying a foundation for a more personalized discussion.

Adult↗

PubMed2005

Micromanaging death: process preferences, values, and goals in end-of-life medical decision making.

PURPOSE: This study examined patients' and surrogates' attitudes about using advance directives to manage end-of-life medical care. It also explored process preferences, or how patients want decisions to be made. DESIGN AND METHODS: Data come from the third wave of the Advance Directives, Values Assessment, and Communication Enhancement project, a longitudinal study designed to investigate psychological assumptions underlying the use of advance directives. Three-hundred thirty-seven outpatients aged 65 and older and their designated surrogate decision makers completed interviews and questionnaires. RESULTS: Very few individuals wished to document specific medical treatment preferences and mandate that they be followed, without exception, near death. Most desired to express more general preferences, such as values and goals for care, in addition to (or, instead of) specific treatment preferences and to allow surrogate decision makers leeway in decision making. Patient-to-patient variability with regard to process preferences was substantial, as was surrogates' misunderstanding of the patients' process preferences. IMPLICATIONS: Very few individuals may desire the standard approach to advance care planning whereby preferences for specific life-sustaining treatments are documented and these requests are strictly followed near death. Instead, patient autonomy may be better served by emphasizing discussion of process preferences and leeway in decision making.

Advance Directives↗

PubMed1998

Implementing breast and cervical cancer prevention programs among the Houma Indians of southern Louisiana: cultural and ethical considerations.

This paper provides an overview of the ethical and cultural issues that were taken into account in planning a cross-cultural study of barriers to breast and cervical cancer screening among Houma Indian women who reside in Terrebonne Parish, Louisiana. In such cross-cultural studies, the investigators and members of the target population are from different cultural backgrounds. In planning the study, ethical principles and cultural norms were carefully specified to ensure that the welfare of the participants would be protected and potential benefits maximized. This experience with the Houma Indian Nation illustrates the need for greater participation of research subjects in the planning and implementation of studies on their behalf. An ethical, culturally sensitive approach to cancer control research is needed to address the health concerns of Native American populations.

Adolescent↗

PubMedDate not supplied

Gender and physician-assisted suicide: an analysis of the Kevorkian cases, 1990-1997.

This study examines the seventy-five suicide cases Dr. Jack Kevorkian acknowledged assisting during the period between 1990-1997. Although these cases represent a range of regional and occupational backgrounds, a significant majority are women. Most of these individuals had a disabling, chronic, nonterminal-stage illness. In five female cases, the medical examiner found no evidence of disease whatsoever. About half of the women were between the ages of forty-one and sixty, and another third were older adults. Men's conditions were somewhat less likely than women's to be chronic and nonterminal-stage. The main reasons for the hastened death mentioned by both the person and their significant others were having disabilities, being in pain, and fear of being a burden. The predominance of women among Kevorkian's assisted suicides contrasts with national trends in suicide mortality, where men are a clear majority. It is possible that individuals whose death was hastened by Kevorkian are not representative of physician-assisted suicide cases around the country, because of Kevorkian's unique approach. Alternatively, the preponderance of women among Kevorkian's assisted suicides may represent a real phenomenon. One possibility is that, in the United States, assisted suicide is particularly acceptable for women. Individual, interpersonal, social, economic, and cultural factors encouraging assisted suicide in women are examined.

Adult↗

PubMed2003

Does it matter who you are or what you gain? An experimental study of preferences for resource allocation.

Using an experimental conjoint-analysis like approach, preferences for resource allocation were studied. An interactive survey was developed which was published in the World Wide Web. A convenience sample of undergraduate students participated in the study. Subjects were confronted with nine pairwise scenarios describing hypothetical patient groups in need of life-saving treatments. The patient groups presented differed in terms of their health-related lifestyle, socioeconomic status, age, life expectancy, quality of life after treatment and whether they had received extensive medical care in the past. Participants were asked to allocate a finite budget to each patient group. All attributes used in this study significantly influenced respondents' preferences on how to allocate the budget between patient groups. The general importance of attributes used in the QALY approach is supported by this study with quality of life being a central criterion. The distributional patterns observed were, however, different from those expected when rigorously adhering to the QALY framework: In only a very small fraction of allocations subjects distributed the entire budget strictly on the patient group expecting the highest QALY gain. The vast majority of responders was willing to trade efficiency for a more equal distribution of resources. The approach described can be used to analyze the importance people place on different attributes in resource allocation decisions and to study preferences for the final distribution of resources.

Age Factors↗

PubMed1998

Factors influencing decisions about donation of the brain for research purposes.

OBJECTIVES: to find out the attitudes to brain donation for research purposes and factors involved in decision-making in elderly people. DESIGN: questionnaire administered after the decision had been made. SETTING AND SUBJECTS: 200 of the 640 people in Nottingham aged 67-100 who were assessed as part of the Medical Research Council multicentre Cognitive Function and Ageing Study of 2,518 people over 65 and were approached to consider brain donation for the neuropathology component of the study of dementia incidence. RESULTS: Most people completing the questionnaire had positive or neutral feelings about being approached. Positive influences included: personal approach, awareness of need for research and of suffering caused by dementia and a desire to help others. Many had fears about not being really dead, about post mortem examinations and feeling pain after death. Most preferred cremation and these were much more likely to donate. Two-thirds thought death was not talked about enough: 65% of those visited found talking helpful. Relatives had an important influence, usually dissuading the person from donating. CONCLUSIONS: some families who agreed to a relative's decision to donate only did so after discussing it together well in advance of death would have been unlikely to have agreed had they been approached for the first timeonly after death. There is a need to: (i) talk more about death, addressing people's fears, (ii) increase awareness of the need for autopsies and donation for research and (iii) provide more training in talking about death andautopsies.

Aged↗

PubMed2003

The practice setting: site of ethical conflict for some mothers and midwives.

Practitioners' ethical orientation and responses vary between practice settings. Yet, currently, the ethics for midwifery practice that is explicit in the literature and which provides the ideals of socialization into practice, is that of bio(medical)ethics. Traditional bioethics, developed because of World War II atrocities and increased scientific research, is based on moral philosophy, normative theory, abstract universal principles and objective problem solving, all of which focus on right and wrong 'action' for resolving dilemmas. They exclude context and relationship. Personal narratives of mothers and midwives contest the appropriateness of these accepted values and systems for childbirth because they induce conflict between workplace/service provider ethics and personal/professional midwifery ethics. In contrast to the disembedded and disembodied approach of biomedical ethics, an ethically adequate response in midwifery practice resonates more with the ethics of intimates, such as feminist virtue ethics.

Attitude of Health Personnel↗

PubMed2005

The routine and the traumatic in prenatal genetic diagnosis: does clinical information inform patient decision-making?

With the increasing technical sophistication of medicine, clinicians' task of assuring patient informed consent is increasingly elusive. Taking the example of prenatal genetic testing, we examine efforts to communicate the complexities of genetic knowledge and risk calculation to patients. In this qualitative, descriptive study, we interviewed 50 clinicians and 40 patients, and observed 101 genetic counseling sessions. We found the clinicians and patients have different goals, purposes, and values regarding testing, which affect their clinical interactions. The information the clinicians provide patients reflects their clinical interest in identifying and controlling pathophysiology, while patients, in contrast, are most concerned with protecting and nurturing their pregnancy. We argue informed patient decision-making about prenatal testing options requires information that is responsive to patient interests. We recommend developing a shared decision-making approach, to facilitate the full participation of both clinicians and patients in the decision-making process.

Adult↗

PubMed2006

How nursing ethics as a subject changes: an analysis of the first 11 years of publication of the journal Nursing Ethics.

By analysing the first, second, 10th and 11th years of publication (i.e. volumes 1, 2, 10, 11) of Nursing Ethics, I will show the significant visible trends in the articles and draw some conclusions. The trends are visible at various levels: from simple analysis of an issue, or a comment on a situation in the early years, to in-depth philosophical and research studies; and from short statements to much longer articles. The ethical approaches used go from either none or unquestioned assumptions to several approaches used in any one study. This corresponds to the general postmodern trend in society. The interpretation made of these trends is of a kind of protest at nurses and nursing being devalued. Although this is expressed negatively, the positive message conveyed is that nurses are now taking their professional life into their own hands, vigorously and more daringly than a decade ago.

Bibliometrics↗

PubMedDate not supplied

Consent to treatment with zidovudine among HIV-infected patients.

Zidovudine delays the progression of disease in asymptomatic or mildly symptomatic patients infected with human immunodeficiency virus (HIV), but it can cause serious adverse reactions, a fact which makes zidovudine treatment undesirable to some patients. In this study, zidovudine was offered to HIV-infected patients with CD4 leukocyte counts between 200 and 500 cells/microL, and the acceptance or refusal of therapy was recorded over a 4-month period. Of 73 patients approached, 49 (67%) consented to the therapy (23 asymptomatic and 26 with AIDS-related complex). The high acceptance rate of zidovudine among both asymptomatic and mildly symptomatic HIV patients raises the question of finding additional financial resources and health care providers for close monitoring of side effects.

Acquired Immunodeficiency Syndrome↗

PubMedDate not supplied

Scope and impact of financial conflicts of interest in biomedical research: a systematic review.

CONTEXT: Despite increasing awareness about the potential impact of financial conflicts of interest on biomedical research, no comprehensive synthesis of the body of evidence relating to financial conflicts of interest has been performed. OBJECTIVE: To review original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research. DATA SOURCES: Studies were identified by searching MEDLINE (January 1980-October 2002), the Web of Science citation database, references of articles, letters, commentaries, editorials, and books and by contacting experts. STUDY SELECTION: All English-language studies containing original, quantitative data on financial relationships among industry, scientific investigators, and academic institutions were included. A total of 1664 citations were screened, 144 potentially eligible full articles were retrieved, and 37 studies met our inclusion criteria. DATA EXTRACTION: One investigator (J.E.B.) extracted data from each of the 37 studies. The main outcomes were the prevalence of specific types of industry relationships, the relation between industry sponsorship and study outcome or investigator behavior, and the process for disclosure, review, and management of financial conflicts of interest. DATA SYNTHESIS: Approximately one fourth of investigators have industry affiliations, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions. Eight articles, which together evaluated 1140 original studies, assessed the relation between industry sponsorship and outcome in original research. Aggregating the results of these articles showed a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also associated with restrictions on publication and data sharing. The approach to managing financial conflicts varied substantially across academic institutions and peer-reviewed journals. CONCLUSIONS: Financial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways.

Academies and Institutes↗