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Objectives: To assess whether persons with amyotrophic lateral sclerosis (ALS) are at risk of a therapeutic misconception (TM) in which they misconceive research as treatment or overestimate the likelihood of its benefit., Methods: 72 patients with ALS recruited via academic and patient organisations were surveyed using a hypothetical first-in-human intervention study scenario. We elicited their understanding of the purpose of the study ('purpose-of-research question') and then asked how they interpreted the question. We then asked for an estimate of the likelihood that their ALS would improve by participating and asked them to explain the meaning of their estimates., Results: Although 10 of 72 (14%) subjects incorrectly said that the intervention study was 'mostly intending to help [me]' in response to the purpose-of-research question, 7 of those 10 thought that the question was asking them about their own motivations for participating. Overall, only one of 72 respondents (1.4%) both understood the purpose-of-research question as intended and gave the incorrect response. Subjects' mean estimate of likelihood of benefit was 31% (SD 26). This was due to 29 of 72 of respondents providing high estimates (50%-54% likelihood), which they said were expressions of hope and need for a positive attitude; among those who said their estimates meant 'those are the facts' or 'there is a lot of uncertainty', the estimates were much lower (12.6% and 18.5%, respectively)., Conclusions: In this group of patients with ALS considering a hypothetical first-in-human intervention study, apparent TM responses have alternative explanations and the risk of true TM appears low., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

A closer look at the lived illness experiences of medical professionals themselves shows that shared decision making is in need of a logic of care. This paper underlines that medical decision making inevitably takes place in a messy and uncertain context in which sharing responsibilities may impose a considerable burden on patients. A better understanding of patients' lived experiences enables healthcare professionals to attune to what individual patients deem important in their lives.This will contribute to making medical decisions in a good and caring manner, taking into account the lived experience of being ill.

Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about 'voluntariness', underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge.

Background: Although medical ethicists and educators emphasise patient-centred decision-making, previous studies suggest that patients often prefer their doctors to make the clinical decisions., Objective: To examine the associations between a preference for physician-directed decision-making and patient health status and sociodemographic characteristics., Methods: Sociodemographic and clinical information from all consenting general internal medicine patients at the University of Chicago Medical Center were examined. The primary objectives were to (1) assess the extent to which patients prefer an active role in clinical decision-making, and (2) determine whether religious service attendance, the importance of religion, self-rated spirituality, Charlson Comorbidity Index, self-reported health, Vulnerable Elder Score and several demographic characteristics were associated with these preferences., Results: Data were collected from 8308 of 11,620 possible participants. Ninety-seven per cent of respondents wanted doctors to offer them choices and to consider their opinions. However, two out of three (67%) preferred to leave medical decisions to the doctor. In multiple regression analyses, preferring to leave decisions to the doctor was associated with older age (per year, OR=1.019, 95% CI 1.003 to 1.036) and frequently attending religious services (OR=1.5, 95% CI 1.1 to 2.1, compared with never), and it was inversely associated with female sex (OR=0.6, 95% CI 0.5 to 0.8), university education (OR=0.6, 95% CI 0.4 to 0.9, compared with no high school diploma) and poor health (OR=0.6, 95% CI 0.3 to 0.9)., Conclusions: Almost all patients want doctors to offer them choices and to consider their opinions, but most prefer to leave medical decisions to the doctor. Patients who are male, less educated, more religious and healthier are more likely to want to leave decisions to their doctors, but effects are small.

Objective: Recent legislation mandating the inclusion of children in clinical trials has resulted in an increase in the number of children participating in research. We reviewed the literature regarding the reasons parents chose to accept or decline an invitation to enroll their children in clinical research., Methods: We searched for qualitative studies, written in the English language that considered the experiences of parents who had been invited to enrol their children in research. SCOPUS and Web of Knowledge electronic databases and reference lists of retrieved articles and review papers were searched. Retrieved articles were synthesised using the narrative synthesis method., Results: 16 qualitative studies exploring the experiences of parents living in five countries whose children had a range of health conditions of varying severity were included. The health status of the child appeared to influence parents' reasons for participation. Parents whose children had life threatening conditions often considered they had no choice but to participate and many welcomed the innovation offered through research participation. Such parents also viewed the risks of research less negatively than those whose children were healthy or in the stable stage of a chronic condition. This raises questions regarding the voluntariness of informed consent by such parents., Conclusions: A tailored approach is needed when discussing research participation with parents of eligible children. While parents of healthy children may be more open to discussions of altruism, those whose children have life threatening illnesses should be given adequate information about the alternatives to, and risks of, research participation.

There is empirical evidence that many patients want information about treatment options even though they do not want to take a full part in decision-making about treatment. Such evidence may have considerable ethical implications but is methodologically problematic. It is argued here that, in fact, it is not at all surprising that patients' informational interests should be separable from (and often stronger than) their interests in decision-making. A number of different reasons for wanting information are offered, some to do with the content of information; some with the process, others with the fact or occasion of informing. This philosophical clarification leads to some suggestions for further empirical study.

Study Objectives: The emergency department (ED) provides an arena for patient enrollment into a variety of research studies even for non-critically ill patients. Given the types of illness, time constraints and sense of urgency that exists in the ED environment, concern exists about whether research subjects in the ED can provide full consent for participation. We sought to identify enrolled research subjects' perspectives on the informed consent process for research conducted in the ED., Methods: This was a prospective, observational study of ED subjects, 18 years or older, who had been approached to participate in research in the ED and who were judged to have decision-making capacity. Exclusions were critical illness and refusal to participate. Subjective were followed up within 1 week after enrolling using structured phone interviews by trained interviewers., Results: During the study period, 229 eligible patients were approached to participate in both a target study and this study. Of these, 66% (150/229) agreed to participate in this study, at least to the extent of allowing us access to their demographic data. The study participant group was similar in terms of gender to this particular ED's patient population but had significantly more African-Americans and persons older than 45., Conclusion: Despite rigorous time constraints and rapid throughput times, the majority of subjects who consented to research participation in the ED felt that they were sufficiently informed and had adequate time to decide to participate.

The Treatment Escalation Plan (TEP) was introduced into our trust in an attempt to improve patient involvement and experience of their treatment in hospital and to embrace and clarify a wider remit of treatment options than the Do Not Resuscitate (DNR) order currently offers. Our experience suggests that the patient and family are rarely engaged in DNR discussions. This is acutely relevant considering that the Mental Capacity Act (MCA) now obliges these discussions to take place. The TEP is a form that the doctor completes, ideally with the competent patient or close relative, documenting what treatment options would be appropriate if that patient were to become acutely unwell. Ventilation of the lungs, cardiac resuscitation, renal replacement therapy, intravenous fluids and antibiotics are all discussed. The study evaluated patient and relative experiences with the TEP. 55 patients or their relatives were interviewed regarding their experience of the TEP and thoughts regarding the process. 96% of patients and relatives evaluated thought that the TEP was a good idea. Free text comments were all positive and only 34% of patients claimed to feel anxious when completing the form. Following this study, the TEP has been expanded hospital wide and into the community within our trust. Discussions are currently taking place in hospitals within our region to introduce the TEP form into other local trusts.

Background: Central to the involvement of children in health research is the notion of risk. In this paper we present one of the factors, a matter of trust, that shaped Canadian parents' and children's perceptions and assessments of risk in child health research., Participants and Methods: Part of a larger qualitative research study, 82 parents took part an in-depth qualitative interview, with 51 parents having children who had participated in health research and 31 having children with no research history. 51 children ranging from 6 to 19 years of age were also interviewed, with 28 having a history of participation in child health research and 23 having no history. Children also took part in 3 focus groups interviews. Themes emerged through a grounded theory analysis of coded interview transcripts., Findings: The presence or absence of trust was not only perceived by parents and children as a contributing factor to involving children in health research, but also shaped their perceptions and assessments of risk. Three interrelated subthemes identified were: (1) relationships of trust; (2) placing trust in symbols of authority; and (3) the continuum of trust., Conclusions: Our study reinforces that trust is an important factor when parents assess risk in child health research and shows that children use the language of trust in relation to risk. More discussion regarding trust in training researchers is warranted given the trust in researchers and institutions evident in this study. We also recommend further study of the continuum of trust in child health research.

Background and Objective: Code status discussions may fail to address patients' treatment-related goals and their knowledge of cardiopulmonary resuscitation (CPR). This study aimed to investigate patients' resuscitation preferences, knowledge of CPR and goals of care. Design, setting, patients and measurements: 135 adults were interviewed within 48 h of admission to a general medical service in an academic medical centre, querying code status preferences, knowledge about CPR and its outcome probabilities and goals of care. Medical records were reviewed for clinical information and code status documentation., Results: 41 (30.4%) patients had discussed CPR with their doctor, 116 (85.9%) patients preferred full code status and 11 (8.1%) patients expressed code status preferences different from the code status documented in their medical record. When queried about seven possible goals of care, patients affirmed an average of 4.9 goals; their single most important goals were broadly distributed, ranging from being cured (n = 36; 26.7%) to being comfortable (n = 8; 5.9%). Patients' mean estimate of survival to discharge after CPR was 60.4%. Most patients believed it was helpful to discuss goals of care (n = 95; 70.4%) and the chances of surviving in hospital CPR (n = 112; 83.0%). Some patients expressed a desire to change their code status after receiving information about survival following in hospital CPR (n = 11; 8.1%) or after discussing goals of care (n = 2; 1.5%)., Conclusions: Doctors need to address patients' knowledge about CPR and take steps to avoid discrepancies between treatment orders and patients' preferences. Addressing CPR outcome probabilities and goals of care during code status discussions may improve patients' knowledge and influence their preferences.

Objectives: To elicit the perceptions and preferences of patients with rheumatoid arthritis regarding information and participation in treatment decision-making. To analyse the patients' narratives on the background of the ethical discourse on various approaches to treatment decision-making., Design: In-depth interviews with themes identified using principles of grounded theory., Participants: 22 patients with long-standing rheumatoid arthritis., Main Outcome Measures: Qualitative data on patients' perceptions and preferences regarding information and participation in decision-making about treatment., Results: Decision-making about treatment has been described by the patients as a process consisting of different stages with shifting loci of control and responsibility. Patients initially received one treatment recommendation and were not aware of alternative treatment options. Those participants in this study who wanted information about negative effects of a treatment cited "interest in one's own health" and the potential "use of information" as reasons for their preference. The physicians' expert knowledge and clinical experience regarding the effects of medication were cited as arguments by patients for a treatment recommendation., Conclusions: The patients' accounts of decision-making about treatment differ from models of physician-patient relationship that have been put forward in ethical discourse. These differences may be relevant with respect to the starting point of an ethical analysis of treatment decision-making. Patients' accounts with respect to a lack of information on treatment alternatives point to ethically relevant challenges regarding treatment decision-making in clinical practice.

Introduction: This study, the first of its kind in Iran, was to assess Iranian patients' preferences for receiving information and participating in decision-making and to evaluate their satisfaction with how medical information is given to them and with their participation in decision-making at present., Method and Materials: 299 of 312 eligible patients admitted to general internal medicine or surgery wards from May to December 2006 were interviewed according to a structured questionnaire. The questionnaire contained questions about patients' preferences regarding four domains of information and their participation in decision-making. Patients' responses were measured on a visual analogue scale graded from 1 to 10., Results: The mean (SD) score for desire to receive information was 8.88 out of 10 (1.5) and for participation in medical decision-making was 7.75 out of 10 (3). The desire to receive information was greater in women than men (9.0 (1.5) vs 7.8 (1.4), p = 0.025). It was also correlated with their education (r = 0.2, p = 0.001) and their estimation of the severity of their own disease (r = 0.13, p = 0.027). The score for preference to participate in decision-making was higher in women than in men (7.95 (2.8) and 7.0 (3.2), respectively; beta = 0.8, p = 0.022) and was negatively correlated with education (r = -0.14, p = 0.015)., Discussion: This study shows that Iranian patients are highly interested in receiving information about their condition and participating in clinical decision-making. No predictive variable for such attitudes was found; therefore, the only way for the physician to recognise patients' desire is to ask them explicitly.

Objectives: The aim of this study is to evaluate the views of cancer patients on patient rights in the context of the right to information and autonomy according to articles related to the issue in the "Patient Rights Regulation"., Methods: The research was conducted among cancer patients in the medical oncology department of a research and practice hospital using a random sampling method between June and September 2005. Data were collected during face-to-face interviews using a questionnaire., Results: There was a high rate of positive response to the items that the patients have the right to be informed (86.5%), that the physician should inform the patient on the diagnosis and the treatment (92.3%) and that the physician is obliged to inform the patient (76.9%). Only 43.3% of the patients stated that the patient has the right to refuse the treatment recommended by the physician. The participants mostly agreed that the patient should participate in decisions about the treatment and that patient consent should be given (78.8%)., Conclusions: There are extensive efforts in Turkey towards making patient rights a significant supportive component of health services. For patient rights to become a natural part of medical practice it is necessary to give priority to education of both patients and physicians about patient rights and to lay emphasis on an ethical approach in the patient-physician relationship.

Recently, commentators close to and within the UK government have claimed that patient choice can increase equity in the context of the National Health Service. This article critically examines the basis for this claim through analysis of recent speeches and publications authored by secretaries of state for health and their policy advisers. It is concluded that this claim has not developed prospectively from an analysis of the causes of healthcare inequity, or even with a consistent normative definition of equity. The limited justification that is "framed in causal explanations" of inequity has suffered from an apparent disregard of the available evidence.

Objectives: To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15-45 years perceive the trial and whether they know that not all trial capsules are the same, and to identify factors associated with this knowledge., Methods: 60 semistructured interviews and 12 focus groups were conducted to explore subjects' perceptions of the trial. Steps were taken to address areas of low comprehension, including retraining fieldworkers. 1971 trial subjects were randomly selected for a survey measuring their knowledge that not all trial capsules are the same. The subjects' fieldworkers were also interviewed about their characteristics and trial knowledge. Factors associated with knowledge were explored using multi-level modeling., Results: Although subjects knew they were taking part in research, most thought they were receiving an active and beneficial medication. Variables associated with knowledge were education and district of residence. Radio broadcasts benefited those with some schooling. Fieldworkers' characteristics were not associated with subjects' knowledge., Conclusions: Research and debate on new or improved consent procedures are urgently required, particularly for subjects with little education.

The notion of patients' duties has received periodic scholarly attention but remains overwhelmed by attention to the duties of healthcare professionals. In a previous paper the author argued that patients in publicly funded healthcare systems have a duty to participate in clinical research, arising from their debt to previous patients. Here the author proposes a greatly extended range of patients' duties grounding their moral force distinctively in the interests of contemporary and future patients, since medical treatment offered to one patient is always liable to be an opportunity cost (however justifiable) in terms of medical treatment needed by other patients. This generates both negative and positive duties. Ten duties-enjoining obligations ranging from participation in healthcare schemes to promoting one's own earliest recovery from illness-are proposed. The characteristics of these duties, including their basis, moral force, extent and enforceability, are considered. They are tested against a range of objections-principled, societal, epistemological and practical-and found to survive. Finally, the paper suggests that these duties could be thought to reinforce a regrettably adversarial characteristic, shared with rights-based approaches, and that a preferable alternative might be sought through the (here unexplored) notion of a "virtuous patient" contributing to a problem-solving partnership with the clinician. However, in defining and giving content to that partnership, there is a clear role for most, if not all, of the proposed duties; their value thus extends beyond the adversarial context in which they might first be thought to arise.

Background: There is a shortage of reports on what potential recipients of implantable cardioverter-defibrillators (ICDs) need to be informed about and what role they can and want to play in the decision-making process when it comes to whether or not to implant an ICD., Aims: To explore how patients with heart failure and previous episodes of malignant arrhythmia experience and view their role in the decision to initiate ICD treatment., Patients and Methods: A qualitative content analysis of semistructured interviews was used. The study population consisted of 31 outpatients with moderate heart failure at the time of their first ICD implantation., Setting: The study was performed at Sahlgrenska University Hospital, Göteborg, Sweden., Results: None of the respondents had discussed the alternative option of receiving treatment with anti-arrhythmic drugs, the estimated risk of a fatal arrhythmia, or the expected time of survival from heart failure in itself. Even so, very little criticism was directed at the lack of information or the lack of participation in the decision-making process. The respondents felt that they had to rely on the doctors' recommendation when it comes to such a complex and important decision. None of them regretted implantation of the ICD., Conclusions: The respondents were confronted by a matter of fact. They needed an ICD and were given an offer they could not refuse, simply because life was precious to them. Being able to give well-informed consent seemed to be a matter of less importance for them.

Objectives: To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics., Methods: Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to (1) receive a new drug outside of a study, (2) receive a new drug as part of a study and (3) participate in a randomised controlled trial (RCT) for a new drug. Patients were also asked about participation in studies of invasive procedures., Results: 213 patients from a geriatric clinic and 207 from an emergency department were surveyed. Two thirds of patients from the geriatric clinic and 83% from the emergency department were willing to receive an experimental drug outside of a study. Patients were less willing to participate in a study of the new drug and even less likely to participate in an RCT for the new drug (chi(2) test for trend, p<0.001 for both settings). Patients were less likely to participate in a study of thoracotomy than in a study that required placement of a femoral catheter (p = 0.008 for the geriatric clinic, p = 0.01 for the emergency department). Willingness to participate was not associated with trust in the doctors., Conclusions: Study design and invasiveness of the intervention were associated with the willingness of patients to participate in resuscitation studies that require exception from informed consent.

Objective: To study the preferences of patients for information related to elective procedures., Methods: A survey was carried out using a sample of 187 women. The majority of whom were on a low-income, who obtained obstetric or gynaecological services at St Joseph Regional Medical Center in Milwaukee, Wisconsin, while they were in a waiting room., Results: Many of the complications, including those that are uncommon and less serious, were considered to be relevant to the medical decisions of most patients. Average seriousness ratings associated with complications of various elective procedures were in the range of moderate to high. A frequency of complications of 1:100 or higher would factor into most women's elective treatment decisions. Women indicated a preference for receiving as much or more information pertaining to complications associated with particular elective obstetric or gynaecological procedures as other elective procedures., Conclusion: Most women wish to be informed of risks and treatment alternatives, rate many complications as serious, and are likely to use information provided to make elective treatment decisions.

Aim: To improve clinical and ethical understanding of patient preferences for information and involvement in decision making., Objectives: To develop and evaluate a clinical tool to elicit these preferences and to consider the ethical issues raised., Design: A before and after study., Setting: Three UK hospices., Participants: Patients with advanced life-threatening illnesses and their doctors., Intervention: Questionnaire on information and decision-making preferences., Main Outcome Measures: Patient-based outcome measures were satisfaction with the amount of information given, with the way information was given, with family or carer information, and confidence about future decision making. Doctor-based outcome measures were confidence in matching information to patient preference, matching family or carer communication to patient preference, knowing patient preferences and matching future decision making with patient preference., Results: Of 336 admissions, 101 patients (mean age 67.3 years, 47.5% men) completed the study (control, n = 40; intervention, n = 61). Patient satisfaction with the way information was given (chi2 = 6.38, df = 2, p = 0.041) and family communication (chi2 = 14.65, df = 2, p < 0.001) improved after introduction of the tool. Doctor confidence improved across all outcome measures (all p values < 0.001)., Conclusions: Patient satisfaction and doctor confidence were improved by administering the questionnaire, but complex ethical issues were raised by implementing and applying this research. The balance of ethical considerations were changed by advanced life-threatening illness, because there is increased risk of harm through delivery of information discordant with the patient's own preferences. The importance of truly understanding patient preferences towards the end of life is highlighted by this study.

This article gives a brief overview of the state of the art concerning physical restraint use among older persons in nursing homes. Within this context we identify some essential values and norms that must be observed in an ethical evaluation of physical restraint. These values and norms provide the ethical foundation for a number of concrete recommendations that could give clinical and ethical support to caregivers when they make decisions about physical restraint. Respect for the autonomy and overall wellbeing of older persons, a proportional assessment of the advantages and disadvantages, a priority focus on the alternatives to physical restraint, individualised care, interdisciplinary decision making, and an institutional policy are the central points that make it possible to deal responsibly with the use of physical restraint for older persons in nursing homes.

Information is usually supposed to be a prerequisite for people making decisions on whether or not to participate in a clinical trial. Previously conducted studies and research ethics scandals indicate that participants have sometimes lacked important pieces of information. Over the past few decades the quantity of information believed to be adequate has increased significantly, and in some instances a new maxim seems to be in place: the more information, the better the ethics in terms of respecting a participant's autonomy. The authors hypothesise that the dose-response curve from pharmacology or toxicology serves as a model to illustrate that a large amount of written information does not equal optimality. Using the curve as a pedagogical analogy when teaching ethics to students in clinical sciences, and also in engaging in dialogue with research institutions, may promote reflection on how to adjust information in relation to the preferences of individual participants, thereby transgressing the maxim that more information means better ethics.

Background and Objectives: There are few insights from sub-Saharan Africa on research participants' experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa., Method: Four to 12 months after completion of the trials, participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration., Results: A total of 334 participants (93% of the original vaccine trial sample; mean age 68 years, median level of education grade 8, 69% women) completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication., Conclusion: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored.

Objective: The objective of the current study was to maximise the amount of information children and adolescents understand about the risks and benefits associated with participation in a biomedical research study., Design: Participants were presented with one of six hypothetical research protocols describing how to fix a fractured thigh using either a "standard" cast or "new" pins procedure. Risks and benefits associated with each of the treatment options were manipulated so that for each one of the six protocols there was either a correct or ambiguous choice., Participants and Setting: Two hundred and fifty one children, ages 6-15 (53% boys), and 237 adults (30% men) were interviewed while waiting for a clinic appointment at the Hospital for Sick Children., Results: Using standardised procedures and questionnaires, it was determined that most participants, regardless of age group, were able to understand the basic purpose and procedures involved in the research, and most were able to choose the "correct" operation. The younger children, however, showed an overall preference for a cast operation, whereas the older participants were more likely to choose the pins., Conclusions: By creating age appropriate modules of information, children as young as six years can understand potentially difficult and complex concepts such as the risks and benefits associated with participation in biomedical research. It appears, however, that different criteria were used for treatment preference, regardless of associated risks; older participants tended to opt for mobility (the pins procedure) whereas younger participants stayed with the more familiar cast operation.

Background: In the USA, the Food and Drug Administration waiver of informed consent permits certain emergency research only if community consultation occurs. However, uncertainty exists regarding how to define the community(ies) or their representatives., Objective: To collect data on the actual preferences and values of a group-those at risk for stroke-most directly affected by the waiver of informed consent for emergency research., Design: Face to face focused interviews were conducted with 12 patients who were hospitalised with a stroke diagnosis in the previous year. The interviews were audiotaped and a transcript based method was used for their analysis., Results: All 12 participants felt "that it was important that new treatments for stroke be developed", but they were initially confused about the distinction between "research for stroke" and "emergency research for stroke". However, after explanation, most (n = 10; 83%) expressed willingness to participate in the latter. In the absence of a surrogate to give informed consent in a stroke emergency situation, the majority (n = 11; 92%) said they would want the physician to "go ahead and enrol them in the trial"., Conclusions: This study is the first to identify the values and concerns of individuals most directly affected by stroke emergency research. Further interviews and focus groups are needed to develop and test a validated questionnaire on the preferences and values surrounding emergency research for stroke.

Objective: Population based cohort studies involving genetic research have been initiated in several countries. However, research published to date provides little information on the willingness of the general population to participate in such studies. Furthermore, there is a need to discover the optimal methods for acquiring fully informed consent from the general population. We therefore examined the results of a population based genetic cohort study to identify the factors affecting the participation rate by members of the general public and also specifically to examine the impact of different consent procedures on the rate of participation by prospective candidates and their subsequent withdrawal rate from the study., Design: Descriptive analyses., Setting and Participants: The study evaluated two non-genetic subcohorts comprising 3166 people attending for a health checkup during 2002, and two genetic subcohorts comprising 2195 people who underwent a checkup during 2003., Main Outcome Measurements: Analysis endpoints were differences in participation rates between the non-genetic and genetic subcohorts, differences between providing non-extensive and extensive preliminary information, and changes in participation status between baseline and at 6 months., Results: Participation rates in the genetic subcohorts were 4.7-9.3% lower than those in the non-genetic subcohorts. The odds ratios (OR) of participation in genetic research were between 0.60 and 0.77, and the OR for withdrawal from the research was over 7.70; providing preliminary extensive information about genetic research reduced the withdrawal risks (OR 0.15 for all dependent variables) but worsened participation rates (OR 0.63-0.74)., Conclusions: The general population responded sceptically towards genetic research. It is crucial that genetic researchers utilise an informative and educational consent process worthy of public trust.

Objective: Contemporary ethical accounts of the patient-provider relationship emphasise respect for patient autonomy and shared decision making. We sought to examine the relative influence of involvement in decisions, confidence and trust in providers, and treatment with respect and dignity on patients' evaluations of their hospital care., Design: Cross-sectional survey., Setting: Fifty one hospitals in Massachusetts., Participants: Stratified random sample of adults (N=27 414) discharged from a medical, surgical, or maternity hospitalisation between January and March, 1998. Twelve thousand six hundred and eighty survey recipients responded., Main Outcome Measure: Respondent would definitely be willing to recommend the hospital to family and friends., Results: In a logistic regression analysis, treatment with respect and dignity (odds ratio (OR) 3.4, 99% confidence interval (CI) 2.8 to 4.2) and confidence and trust in providers (OR 2.5, CI 2.1 to 3.0) were more strongly associated with willingness to recommend than having enough involvement in decisions (OR 1.4, CI 1.1 to 1.6). Courtesy and availability of staff (OR 2.5, CI 2.1 to 3.1), continuity and transition (OR 1.9, CI 1.5 to 2.2), attention to physical comfort (OR 1.8, CI 1.5 to 2.2), and coordination of care (OR 1.5, CI 1.3 to 1.8) were also significantly associated with willingness to recommend., Conclusions: Confidence and trust in providers and treatment with respect and dignity are more closely associated with patients' overall evaluations of their hospitals than adequate involvement in decisions. These findings challenge a narrow emphasis on patient autonomy and shared decision making, while arguing for increased attention to trust and respect in ethical models of health care.

The degree and nature of patient involvement in consultations with health professionals influences problem and needs recognition and management, and public accountability. This paper suggests a framework for understanding the scope for patient involvement in such consultations. Patients are defined as co-producers of formal health services, whose potential for involvement in consultations depends on their personal rights, responsibilities and preferences. Patients' rights in consultations are poorly defined and, in the National Health Service (NHS), not legally enforceable. The responsibilities of patients are also undefined. I suggest that these are not to deny, of their own volition, the rights of others, which in consultations necessitate mutuality of involvement through information-exchange and shared decision-making. Preferences should be met insofar as they do not militate against responsibilities and rights.

One hundred inpatients on an acute hospital elderly care unit and 43 of their relatives were interviewed shortly before hospital discharge. Eighty per cent of elderly patients and their relatives were aware of cardiopulmonary resuscitation (CPR). Television drama was their main source of information. Patients and relatives overestimated the effectiveness of CPR. Eighty-six per cent of patients were willing to be routinely consulted by doctors about their own CPR status, but relatives were less enthusiastic about routine consultation. Patients' and relatives' views about the appropriateness of CPR did not differ significantly. Seventeen percent of patients did not desire CPR. However, 64 per cent of patients were ultimately willing to follow their doctor's advice about the appropriateness of CPR. The conclusion reached is that mentally competent, elderly patients but not their relatives should be routinely consulted about their own desire for CPR in order to avoid resuscitating patients against their wishes. Further research is required to find out how patients would feel about resuscitation if they were terminally ill or chronically confused, and how carers would feel about resuscitating such patients.

I argue that the distinction which is current in much writing on medical ethics between autonomous and non-autonomous patients cannot cope comfortably with weak-willed (incontinent) patients. I describe a case involving a patient who refuses a blood transfusion even though he or she agrees that it would be in his or her best interests. The case is discussed in the light of the treatment of autonomy by B Brody and R Gillon. These writers appear to force us to treat an incontinent patient either as autonomous, just like a rational agent whose decisions are in accordance with his beliefs or as non-autonomous, like comatose patients or children. Though neither is entirely satisfactory I opt for describing such patients as autonomous but point out that in cases like this the principle of respect for autonomy does not give a determinate answer about how the patient ought to be treated.

A recent paper in this journal (1) suggests that involving terminally ill patients in choices concerned with Cardio-Pulmonary Resuscitation (CPR) produces 'psychological pain' and therefore is ill-advised. Such a claim rests on anecdotal observations made by the authors. In this paper I suggest that drawing conclusions in ethics, no less than in science, requires a rigorous framework and cannot be relegated to personal observation of a few cases. The paper concludes by suggesting that patients, if we acknowledge their valid interest in making their own choices, must themselves be allowed to make a prior choice about choosing. Those who may not wish to choose may properly be relieved of this burden and may allow another to choose for them. Routinely allowing others to make choices for competent adults, however, is likely to decrease communication with the dying patient and to introduce an atmosphere of suspicion and fear and to exclude the competent patient from his/her rightful place in the community.