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Monitoring patient rights--a clinical seminar.

Israel enacted the Patient Rights Law in 1996. The Law embodies a movement from paternalism to autonomy in doctor-patient relations. The following year, law students at the Israeli Centre for Academic Studies participated in a clinical seminar designed to measure internalisation ofthe Law, through personal interviews with hospitalized patients. The seminar can be adapted for medical students. The methodology is taken from human rights field work. The objective is to use patient rights as indicators of quality of care in medical settings. Students studied the text and principles of the Law in light of personal testimonies taken from relatives and friends. They developed an open-structured questionnaire, and were trained in interviewing with due respect for the patients' dignity and privacy, and the need to obtain their free and informed consent to the interview. The interviews were conducted in Hadassah Hospital, Jerusalem, after receiving approval of the Helsinki Committee. The findings, though in no way statistically valid, are nonetheless interesting. Students received training in listening and advocacy skills. The approach is conciliatory rather than adversarial. The thesis is that respect for patient rights is an efficient tool for quality control, risk management, conflict resolution and prevention of litigation.

Confidentiality↗

[Learning and memory: traditional and systemic approach].

The same empiric event may appear as different facts for authors adhering to different theories. The present work was designed with analyze learning and memory from the viewpoint of systemic approach and to compare this view with the traditional one. Neuron's activity is considered not as a response to synaptic inflow that ensures the conduction of excitation but as means of changing the relation with environment, "action" that helps eliminate the discrepancy between cell's needs and its microenvironment. It is suggested that learning and memory consolidation is based not on a consistent increase in efficacy of synaptic transmission in neuronal chains but on systemogenesis--establishment of new systemic specializations of neurons not necessarily linked directly through synapses. The article discusses the role of systemogenetic processes taking place in normal as well as in pathological state: selection, reconsolidational modifications of previously formed memory store, genes activation, neurogenesis and apoptosis. The systemic understanding of the phenomenon of long-term potentiation is-substantiated. Finally, the scheme is suggested describing variants and stages of memory store formation.

Animals↗

Options for increasing organ donation: the potential role of financial incentives, standardized hospital procedures, and public education to promote family discussion.

Required request laws that mandate hospital personnel to request organ donations have not substantially increased the supply of organs for transplantation. Frustration caused by the continuing shortage of organs has led several experts to promote controversial options for expanding the pool of available organs, including the offer of financial incentives. Pilot programs to test the use of incentives are warranted, but such experiments must be approached cautiously, given the moral qualms they might raise and the availability of other options. One promising strategy is to install standardized hospital procedures to ensure that all potential donors are identified, that every family is approached about the possibility of donation, and that the request is properly structured. The second strategy is to refocus public education to encourage family discussion about organ donation so that the families of those individuals who are disposed to donate will be more likely to grant consent when asked.

Empirical Research↗

The family conference as a focus to improve communication about end-of-life care in the intensive care unit: opportunities for improvement.

The intensive care unit (ICU) represents a hospital setting in which death and discussion about end-of-life care are common, yet these conversations are often difficult. Such difficulties arise, in part, because a family may be facing an unexpected poor prognosis associated with an acute illness or exacerbation and, in part, because the ICU orientation is one of saving lives. Understanding and improving communication about end-of-life care between clinicians and families in the ICU is an important focus for improving the quality of care in the ICU. This communication often occurs in the "family conference" attended by several family members and members of the ICU team, including physicians, nurses, and social workers. In this article, we review the importance of communication about end-of-life care during the family conference and make specific recommendations for physicians and nurses interested in improving the quality of their communication about end-of-life care with family members. Because excellent end-of-life care is an important part of high-quality intensive care, ICU clinicians should approach the family conference with the same care and planning that they approach other ICU procedures. This article outlines specific steps that may facilitate good communication about end-of-life care in the ICU before, during, and after the conference. The article also provides direction for the future to improve physician-family and nurse-family communication about end-of-life care in the ICU and a research agenda to improve this communication. Research to examine and improve communication about end-of-life care in the ICU must proceed in conjunction with ongoing empiric efforts to improve the quality of care we provide to patients who die during or shortly after a stay in the ICU.

Advance Directives↗

Observational study of effect of patient centredness and positive approach on outcomes of general practice consultations.

OBJECTIVE: To measure patients' perceptions of patient centredness and the relation of these perceptions to outcomes. DESIGN: Observational study using questionnaires. SETTING: Three general practices. PARTICIPANTS: 865 consecutive patients attending the practices. MAIN OUTCOME MEASURES: Patients' enablement, satisfaction, and burden of symptoms. RESULTS: Factor analysis identified five components. These were communication and partnership (a sympathetic doctor interested in patients' worries and expectations and who discusses and agrees the problem and treatment, Cronbach's alpha=0.96); personal relationship (a doctor who knows the patient and their emotional needs, alpha=0.89); health promotion (alpha=0.87); positive approach (being definite about the problem and when it would settle, alpha=0.84); and interest in effect on patient's life (alpha=0.89). Satisfaction was related to communication and partnership (adjusted beta=19.1; 95% confidence interval 17.7 to 20.7) and a positive approach (4.28; 2.96 to 5.60). Enablement was greater with interest in the effect on life (0.55; 0.25 to 0.86), health promotion (0.57; 0.30 to 0.85), and a positive approach (0.82; 0.52 to 1.11). A positive approach was also associated with reduced symptom burden at one month (beta=-0.25; -0.41 to -0.10). Referrals were fewer if patients felt they had a personal relationship with their doctor (odds ratio 0.70; 0.54 to 0.90). CONCLUSIONS: Components of patients' perceptions can be measured reliably and predict different outcomes. If doctors don't provide a positive, patient centred approach patients will be less satisfied, less enabled, and may have greater symptom burden and higher rates of referral.

Communication↗

Recruiting patients to medical research: double blind randomised trial of "opt-in" versus "opt-out" strategies.

OBJECTIVE: To evaluate the effect of opt-in compared with opt-out recruitment strategies on response rate and selection bias. DESIGN: Double blind randomised controlled trial. SETTING: Two general practices in England. PARTICIPANTS: 510 patients with angina. INTERVENTION: Patients were randomly allocated to an opt-in (asked to actively signal willingness to participate in research) or opt-out (contacted repeatedly unless they signalled unwillingness to participate) approach for recruitment to an observational prognostic study of patients with angina. MAIN OUTCOME MEASURES: Recruitment rate and clinical characteristics of patients. RESULTS: The recruitment rate, defined by clinic attendance, was 38% (96/252) in the opt-in arm and 50% (128/258) in the opt-out arm (P = 0.014). Once an appointment had been made, non-attendance at the clinic was similar (20% opt-in arm v 17% opt-out arm; P = 0.86). Patients in the opt-in arm had fewer risk factors (44% v 60%; P = 0.053), less treatment for angina (69% v 82%; P = 0.010), and less functional impairment (9% v 20%; P = 0.023) than patients in the opt-out arm. CONCLUSIONS: The opt-in approach to participant recruitment, increasingly required by ethics committees, resulted in lower response rates and a biased sample. We propose that the opt-out approach should be the default recruitment strategy for studies with low risk to participants.

Adult↗

Partial and impartial ethical reasoning in health care professionals.

OBJECTIVES: To determine the relationship between ethical reasoning and gender and occupation among a group of male and female nurses and doctors. DESIGN: Partialist and impartialist forms of ethical reasoning were defined and singled out as being central to the difference between what is known as the "care" moral orientation (Gilligan) and the "justice" orientation (Kohlberg). A structured questionnaire based on four hypothetical moral dilemmas involving combinations of (health care) professional, non-professional, life-threatening and non-life-threatening situations, was piloted and then mailed to a randomly selected sample of doctors and nurses. SETTING: 400 doctors from Victoria, and 200 doctors and 400 nurses from New South Wales. RESULTS: 178 doctors and 122 nurses returned completed questionnaires. 115 doctors were male, 61 female; 50 nurses were male and 72 were female. It was hypothesised that there would be an association between feminine subjects and partialist reasoning and masculine subjects and impartialist reasoning. It was also hypothesised that nurses would adopt a partialist approach to reasoning and doctors an impartialist approach. No relationship between any of these variables was observed.

Attitude of Health Personnel↗

A retrospective analysis of ethics knowledge in physical therapy (1970-2000).

BACKGROUND AND PURPOSE: Purtilo, Guccione, and others have noted that increased clinical autonomy for physical therapists presents more complex ethical dilemmas. The body of literature examining physical therapy ethics, however, is relatively small and has not been analyzed. The primary purposes of this research were: (1) to use multiple perspectives to describe and analyze literature examining ethics in physical therapy from 1970 to 2000, (2) to develop a model to describe the evolution of knowledge of ethics in physical therapy during this period, and (3) to compare the proposed model with the evolutionary models proposed by Purtilo in physical therapy and by Pellegrino in bioethics. SAMPLE: The sample consisted of peer-reviewed journal articles cited in the MEDLINE or Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases between 1970 and 2000 or referenced in Ethics in Physical Therapy. METHODS: A two-phase mixed quantitative and qualitative method was used to analyze publications. In the quantitative phase, the author sorted publications into a priori categories, including approach to ethics, author, decade, country of publication, role of the physical therapist, and component of morality. During the qualitative phase of the research, the author analyzed and sorted the publications to identify common themes, patterns, similarities, and evolutionary trends. These findings were compared with the evolutionary models of Pellegrino and Purtilo. RESULTS: The 90 publications meeting inclusion criteria were predominantly philosophical, using the "principles" perspective; focused on the patient/client management role of the physical therapist; and addressed the moral judgment component of moral behavior. As predicted by Purtilo's model, the focus of identity evolved from self-identity to patient-focused identity, with increasing representation of societal identity. Recurrent themes included the need to further identify and clarify physical therapists' ethical dilemmas, the interrelationship between clinical and ethical decision making, and the changing relationship with patients. DISCUSSION AND CONCLUSION: Although knowledge of ethics grew steadily between 1970 and 2000, this retrospective analysis identified gaps in our current knowledge. Further research is needed to address the unique ethical problems commonly encountered in all 5 roles of the physical therapist; patient perspectives on ethical issues in physical therapy; variety in ethical approaches; factors affecting moral judgment, sensitivity, motivation, and courage; and cultural dimensions of ethical practice in physical therapy.

Ethics, Clinical↗

Organ and tissue donation: a trustwide perspective or critical care concern?

Organ donation has become an accepted practice within the critical care setting; however, tissue donation is seldom considered within the ICU environment and even less in other hospital departments. This study describes the results from an early base line audit performed as the first stage in a larger action research project following the implementation of the Donor Liaison Scheme in an NHS trust. It was designed to assess the current level of knowledge, confidence and value system staff have, working in all areas of the hospital setting in relation to organ and tissue donation. The results from this audit highlight key areas for practice development across all areas of this NHS trust. Many healthcare professionals working within this trust are unaware that donation can be considered. The respondents identified a lack of knowledge and confidence to be able to identify and discuss the options of donation with a family, yet the majority believe strongly that a person's wishes should be respected after death. People who have signed on the NHS ODR anticipate that healthcare professionals will access the ODR and support their family in following through their wishes; therefore, all healthcare professionals should receive education on donation issues as an integral part of bereavement and end of life decision training. Education strategies that adopt an experiential approach should be developed in order to create confidence in healthcare professionals to offer choice in donation options

Attitude of Health Personnel↗

Relational ethics and genetic counseling.

Genetic counseling is viewed as a therapeutic interrelationship between genetic counselors and their clients. In a previous relational ethics research project, various themes were identified as key components of relational ethics practice grounded in everyday health situations. In this article the relational ethics approach is further explored in the context of genetic counseling to enhance our understanding of how the counselor-client relationship is contextually developed and maintained. Qualitative interviews were conducted with six adult clients undergoing genetic counseling for predictive testing. Engagement, dialogue and presence were revealed as relevant to genetic counselor-client relationships. A relational ethics approach in genetic counseling challenges the concept of nondirectiveness and may enhance the outcome of counseling for both counselor and client.

Adult↗

Prenatal HIV tests. Routine testing or informed choice?

OBJECTIVE: To examine how prenatal care providers responded to a new provincial policy of offering HIV testing to all prenatal patients, and to determine factors associated with self-reported high testing rates. DESIGN: Cross-sectional mailed survey. SETTING: Outpatient practices in three Ontario health-planning regions. PARTICIPANTS: Prenatal care providers: 784 family physicians, 200 obstetricians, and 103 midwives were sent questionnaires and were eligible to participate. MAIN OUTCOME MEASURES: Self-reported testing of 80% or more prenatal patients ("high testers") and associated practice characteristics, attitudes, and counseling practices. RESULTS: Response rate was 57% (622/1087): 43% of respondents were high testers. Family physicians were most likely and midwives least likely to be high testers. High testers tended to report that they had adequate knowledge of HIV testing, that HIV risk among their patients warranted testing all of them, and that testing should be routine. Encouraging women to test and not providing written information or choice were independently associated with high testing rates. CONCLUSION: Strongest predictors of high prenatal HIV testing rates were attitudes and practices that favoured a routine approach to testing and that placed little emphasis on informed consent.

AIDS Serodiagnosis↗

Knowledge and attitudes of critical care nurses regarding organ donation.

The purpose of this study was to describe the knowledge, attitudes, personal commitment, and professional involvement of Canadian critical care nurses in organ donation. This was part of a larger study of 4900 Canadian nurses and physicians. 50% of nurses receiving questionnaires responded. Of the 147 critical care nurses who responded to the survey, over 92% supported organ donation in principle. However, only 65.3% had completed organ donor cards. Nurses responded correctly to 71.2% of the questions testing knowledge. Attitudes regarding organ donation tended to be positive, but 85% of nurses indicated reluctance to approach potential organ donors. Critical care nurses scored higher than other groups of nurses on the knowledge, attitude, and professional involvement in organ donation subscales.

Adult↗

Parental role in medical decision-making: fact or fiction? A comparative study of ethical dilemmas in French and American neonatal intensive care units.

Neonatal intensive care has been studied from an epidemiological, ethical, medical and even sociological perspective, but little is known about the impact of parental involvement in decision-making, especially in critical cases. We rely here on a comparative, case-based approach to study the parental role in decision-making within two technologically identical but culturally and institutionally different contexts: France and the United States. These contexts rely on two opposed models of decision-making: parental autonomy in the United States and medical paternalism in France. This paternalism model excludes parents from the decision-making process. We investigate whether parental involvement leads to different outcomes from exclusively medically determined decisions or whether "technological imperatives" outplay all other factors to shape a unique, 'medically optimal' outcome. Using empirical data generated from extensive ethnographic fieldwork, in-depth interviews with 60 clinicians and 71 parents and chart review over a year in two neonatal intensive care units (one in France and one in the US), we analyze the factors that can explain the observed differences in decision-making in medically identical cases. Parental involvement and the legal context play a less role than physicians' differential use of certainty versus uncertainty in prognosis, a conclusion that corroborates the fact that medical control over ethical dilemmas remains even in the context of autonomy. French physicians do not ask parents permission to withdraw care (as expected in a paternalistic context); but symmetrically, American neonatologists (despite the prevailing autonomy model) tend not to ask permission to continue. The study provides an analysis of the making of "ethics", with an emphasis on how decisions are conceptualized as ethical dilemmas. The final conclusion is that the ongoing medical authority on ethics remains the key issue.

Academic Medical Centers↗

Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

BACKGROUND: Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. METHODS: Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. RESULTS: Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. CONCLUSIONS: The issues raised by these data managers have important implications for the successful conduct of clinical trials, particularly the need for an integrated, multidisciplinary approach at all levels of the informed-consent process.

Adult↗

Therapeutic choices made by patients with end-stage cancer.

The Oklahoma Children's Memorial Hospital Oncology Service has developed a new approach for its patients with end-stage cancer. The emphasis is on the patients' acknowledgement of the progression of the disease and the imminence of death, and informed choice between the use of research drugs and no further chemotherapy. Forty-three patients between 6 and 20 years of age participated in a conference of this type. The results demonstrated that they understood that their health was declining. They decided about further therapy autonomously or together with their family. The majority of children who chose supportive care without chemotherapy and lived for a period of time, participated in activities at home as far as their state of health permitted. Severe depression and severe behavioral problems occurred rarely. There was evidence that this open approach enabled patients and family members to communicate openly with each other.

Adolescent↗

Preimplantation genetic diagnosis: patients' experiences and attitudes.

BACKGROUND: This study aims to report the experiences and attitudes of patients who have undergone preimplantation genetic diagnosis (PGD). The extent to which this technique is acceptable to the individuals for whom it is intended is relatively unexplored, and remains a crucial issue that may ultimately determine the value of PGD as an alternative to prenatal diagnosis in high-risk couples. METHODS: An information sheet and questionnaire was distributed to 67 couples who had been treated at the Hammersmith Hospital, London and the Dexeus Institute, Barcelona. RESULTS: One-third of patients had an affected child, over half had previous experience of conventional prenatal diagnosis and over one-third had had terminations of pregnancy because of a genetic risk. Patients perceive the main advantage of PGD to be that only unaffected embryos are transferred to the uterus and thus therapeutic termination of pregnancy can be avoided; the main disadvantage is the low success rate. A total of 41% of patients found the treatment cycle extremely stressful, and, of the 20 patients who had experienced both prenatal diagnosis and PGD, 40% of patients found PGD less stressful, although 35% experienced more stress. Of those couples who contemplated a further pregnancy 76% would choose PGD, 16% would opt for prenatal diagnosis, and 8% no tests at all. CONCLUSIONS: The experience of prenatal diagnosis and termination of pregnancy can be an unwelcome memory and this leads to a demand for an alternative approach. Our data suggest that PGD is acceptable to patients and is a valuable alternative to prenatal diagnosis.

Abortion, Induced↗

Western medical ethics taught to junior medical students can cross cultural and linguistic boundaries.

BACKGROUND: Little is known about teaching medical ethics across cultural and linguistic boundaries. This study examined two successive cohorts of first year medical students in a six year undergraduate MBBS program. METHODS: The objective was to investigate whether Arabic speaking students studying medicine in an Arabic country would be able to correctly identify some of the principles of Western medical ethical reasoning. This cohort study was conducted on first year students in a six-year undergraduate program studying medicine in English, their second language at a medical school in the Arabian Gulf. The ethics teaching was based on the four-principle approach (autonomy, beneficence, non-malfeasance and justice) and delivered by a non-Muslim native English speaker with no knowledge of the Arabic language. Although the course was respectful of Arabic culture and tradition, the content excluded an analysis of Islamic medical ethics and focused on Western ethical reasoning. Following two 45-minute interactive seminars, students in groups of 3 or 4 visited a primary health care centre for one morning, sitting in with an attending physician seeing his or her patients in Arabic. Each student submitted a personal report for summative assessment detailing the ethical issues they had observed. RESULTS: All 62 students enrolled in these courses participated. Each student acting independently was able to correctly identify a median number of 4 different medical ethical issues (range 2-9) and correctly identify and label accurately a median of 2 different medical ethical issues (range 2-7) There were no significant correlations between their English language skills or general academic ability and the number or accuracy of ethical issues identified. CONCLUSIONS: This study has demonstrated that these students could identify medical ethical issues based on Western constructs, despite learning in English, their second language, being in the third week of their medical school experience and with minimal instruction. This result was independent of their academic and English language skills suggesting that ethical principles as espoused in the four principal approach may be common to the students' Islamic religious beliefs, allowing them to access complex medical ethical reasoning skills at an early stage in the medical curriculum.

Cohort Studies↗

Communication and miscommunication in informed consent to research.

Biomedical ethics require that research subjects be aware that the drugs they take or procedures they undergo are designed to fulfill the conditions of the experiment and not to benefit a subject's health. This apparently straightforward distinction between research and treatment is a source of much controversy and misunderstanding. Ethicists have labeled this problem the "therapeutic misconception." This misconception and, more broadly, informed consent have been studied extensively. Nonetheless, the therapeutic misconception persists among research subjects. This paper argues that one factor overlooked in the persistence of the therapeutic misconception is the effect of the theoretical paradigm that guides the practice and analysis of informed consent. The paradigm poses an idealized model of communication that ignores social context. This paper examines informed consent practices associated with a cancer research trial to demonstrate an alternative approach to studying informed consent to research. Through analysis of informed consent session transcripts, it demonstrates the importance of taking account of not only what is said, but how and by whom it is said.

Clinical Trials, Phase I as Topic↗