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Biomedical subjects

N Lynöe

Publications and source records attributed to N Lynöe.

At least 19 recordsLinked to original sources

Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of information.

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.

Clinical Trials as Topic↗

Informed consent in two Swedish prisons: a study of quality of information and reasons for participating in a clinical trial.

OBJECTIVES: To study the quality of informed consent in two samples of prisoners participating in a therapeutic trial. RESULTS: All participants (n=43) were aware of the fact that they had participated in a research project, that they were free to abstain from participation, and that they were free to withdraw from participation at any time. All but six were aware of the objective of the clinical trial and all but three understood the implications of participating. Twenty individuals did not consider the pros and cons. When making their respective decisions, no one felt that they had been subjected to undue persuasion or force. Concerning the reasons for participating, a majority (n=35) supposed that participation would benefit themselves' as the primary reason. Some (n=11) considered the benefits for future patients and science. No differences concerning gender or age were discerned. CONCLUSIONS: The results do not indicate that the informed consent procedure in general was inadequately performed. Rather, the answers provided and the subjects who withdrew indicate that participation was perceived as fully voluntary.

Acupuncture Therapy↗

Fraud, misconduct or normal science in medical research--an empirical study of demarcation.

OBJECTIVES: To study and describe how a group of senior researchers and a group of postgraduate students perceived the so-called "grey zone" between normal scientific practice and obvious misconduct. DESIGN: A questionnaire concerning various practices including dishonesty and obvious misconduct. The answers were obtained by means of a visual analogue scale (VAS). The central (two quarters) of the VAS were designated as a grey zone. SETTING: A Swedish medical faculty. SURVEY SAMPLE: 30 senior researchers and 30 postgraduate students. RESULTS: Twenty of the senior researchers and 25 of the postgraduate students answered the questionnaire. In five cases out of 14 the senior researchers' median was found to be clearly within the interval of the grey zone, compared with three cases for the postgraduate students. Three examples of experienced misconduct were provided. Compared with postgraduate students, established researchers do not call for more research ethical guidelines and restrictions. CONCLUSION: Although the results indicate that consensus exists regarding certain obvious types of misconduct the response pattern also indicates that there is no general consensus on several procedures.

Attitude of Health Personnel↗

Research ethics committees: a comparative study of assessment of ethical dilemmas.

Research ethics committees (REC) constitute an important instrument for the regulation of biomedical research involving human beings. The purposes of this work were to study the ethical reasoning in RECs and to ascertain whether the composition of RECs has any bearing on the decisions subsequently made by them. We used a postal questionnaire, containing authentic cases of research ethical dilemmas, sent to the ten RECs in Sweden (n = 124) and to comparison groups consisting of 200 randomly selected medical researchers, 200 randomly selected healthcare politicians and 200 randomly selected district nurses. The average response rate was 68%. A difference was found in how REC members assess a project in comparison with researchers, healthcare politicians and district nurses. Differences depended on the type of project assessed. The study indicates that membership in RECs may exert a normative influence on its members. It is proposed that this investigation should be followed up by a study with a qualitative design.

Adult↗

When others decide: reasons for allowing patients with Alzheimer's disease to participate in nontherapeutic research.

The quality of information given to family members of patients with Alzheimer's disease was studied. The patients had participated in a pharmacological investigation. The relatives were generally satisfied with the information given, and perceived it as adequate. The reasons given for allowing the patients to participate in the investigation were mainly altruistic.

Aged↗

Informed consent in clinical training--patient experiences and motives for participating.

The purpose of this study was to assess patients' attitudes to and experiences of participating in the clinical training of medical students. Samples of patients (n = 582) selected at random from six different departments (gynaecology, psychiatry, internal medicine, paediatrics, urology and a health care centre with general practitioners) were interviewed by means of a questionnaire. The patients were selected from those who had consulted the actual departments in the last six months of 1995. Four hundred and forty-one patients (76%) answered the questionnaire. Seventy-one per cent of all patients had experience of participating; of these 41% had estimated that they had once or several times participated without being informed. Eighty per cent felt aggrieved if they were not informed. On average 88% were, in principle, positive to participating. Of those who were, in principle, negative a majority had negative experiences of participating. Elderly patients tended to accept participating more often without being informed. Almost all patients seemed to be positive to participating in the education of medical students, although a silent precondition might be that patients should be informed and given the opportunity to abstain.

Adult↗

Loyalty conflicts in medical practice. A comparative study of general practitioners', paediatricians' and gynaecologists' assessments of three cases.

OBJECTIVE: To shed light on attitudes towards loyalty conflicts among general practitioners (GPs) compared with related specialists such as gynaecologists and paediatricians. DESIGN: A postal questionnaire containing three case histories with arguments for and against different ways of acting in loyalty conflicts. The medical problems of the clinical cases varied, but the ethical ones were in principle similar. SETTING: A random sample of all Swedish GPs, gynaecologists, and paediatricians. SUBJECTS: GPs (n = 313), paediatricians (n = 197), and gynaecologists (n = 236). RESULTS: On average 71% of the doctors replied. The gynaecologists differed from the other groups by being markedly loyal to the individual patient especially in one case. The paediatricians tended to reply most consistently and they seemed to favour the family perspective, compared with the other doctors. The GPs' response pattern fell in between the other two groups. CONCLUSIONS: The study indicates that ethical reasoning depends on the doctors' different medical background with regard to specialty. This study should be followed by others in order to give further explanation of the findings.

Adult↗

Doctors' attitudes towards empirical data--a comparative study.

In the assessment of the effects of medical technologies, the focus is most often on the quality of the empirical data. In order to shed light on the question whether medical researchers are really so empirically oriented we conducted the following study. 600 questionnaires were sent by mail to three groups, selected at random: 1) pre-clinical researchers; 2) clinical researchers who received research grants from The Swedish Medical Research Council; and 3) general practitioners. The questionnaire was built around three cases concerning the assessment of the effects of: a) H-2-receptor antagonists, b) coronary by-pass surgery and c) the homeopathic treatment of hay fever. The results indicate that there are rather small differences in how the three groups assessed the three technologies and larger differences within one and the same group concerning different cases. The tendency is that the more one considers that empirical data should be assessed independent of theoretical considerations, the higher are the demands which are placed on the quality and quantity of the empirical documentation, and vice-versa.

Adult↗

Medical ethics--an endeavour for social medicine?

In this paper twelve themes are pointed out as background for the increased interest for medical ethics: New medical knowledge, the democratisation of doctor-patient relationship, changes in the disease panorama, autonomy and its limits, research ethics, collegiate concern, prioritization, ethics of clinical training, immigration and cultural conflicts, changes in the view of the rationality of ethical reasoning, changes in the view of nature in relation to culture and medical students' requests for teaching in medical ethics. It is discussed whether teaching in medical ethics is a matter for social medicine or whether one should pass it on to hospital priests or philosophers.

Education, Medical↗