Shaken baby syndrome and the risk of losing scientific scrutiny.

A systematic review of shaken baby syndrome by the Swedish Agency for Health Technology Assessment and Assessment of Social Services generated numerous reactions from professional organisations, even before the review was published. There was also a lively debate after a paper summarising its findings were published in Acta Paediatrica The various responses are worth debating further, as they raise several important issues with regard to research ethics, having an open debate and publishing scientific findings. CONCLUSION: The responses to the shaken baby syndrome report indicate that scientific scrutiny risks being lost when researchers and organisations are not open to challenging established ideas.

Should physicians fake diagnoses to help their patients?

Are fake diagnoses and false or misleading certificates permissible means of helping patients? This question is examined in relation to four examples from Swedish health care: the sterilisation case, the asylum case, the virginity case, and the adoption case. We argue that both consequentialist and deontological ethical theories, to be reasonable, need to balance values, principles, and interests such as wellbeing, truthfulness, autonomy, personal integrity, trust in the medical profession, and abidance by national legislation. We conclude that it can be justifiable for physicians to fake diagnoses and write false or misleading certificates in order to help patients when not doing so has dire consequences. However, physicians must also consider the long-term effects of making exceptions to honest, non-deceitful behaviour based on the best empirical evidence available. Otherwise valuable social practices might erode and public confidence in physicians be threatened.

Teaching medical ethics: what is the impact of role models? Some experiences from Swedish medical schools.

The goal of the present study was to elucidate what influences medical students' attitudes and interests in medical ethics. At the end of their first, fifth and last terms, 409 medical students from all six medical schools in Sweden participated in an attitude survey. The questions focused on the students' experience of good and poor role models, attitudes towards medical ethics in general and perceived effects of the teaching of medical ethics. Despite a low response rate at some schools, this study indicates that increased interest in medical ethics was related to encountering good physician role models, and decreased interest, to encountering poor role models. Physicians involved in the education of medical students seem to teach medical ethics as role models even when ethics is not on the schedule. The low response rate prevents us from drawing definite conclusions, but the results could be used as hypotheses to be further scrutinised.

The attitudes of patients and physicians towards placebo treatment--a comparative study.

Placebo treatment in clinical practice can be given either in order to comply with the wishes of the patient, or with the purpose of doing good and not causing harm. In the former instance, the procedure may be in accordance with the interests of the patient, yet be in conflict with the interests of the medical profession. In the latter instance, the procedure presupposes that in most cases the patient has not been informed of the nature of the treatment; this type of procedure may jeopardize a trusting patient-doctor relationship. Therefore, it is of interest to investigate both the extent to which patients and physicians feel they can accept placebo treatment and a paternalistic attitude, and in which particular situations. In order to shed some light on this matter, we compiled a questionnaire built around three case histories which problematize placebo treatment and paternalistic acts. The questionnaire was distributed to 100 patients and 100 physicians. 83 patients and 94 physicians responded. The results show that patients and physicians do not automatically follow specific group interests. Physicians are more inclined to respect the patient's option to refuse medical treatment than the patients are inclined to respect a physician's professional autonomy. Patients appear more to be paternalistic in their judgements than physicians, but one cannot rule out the possibility that the answers of the physicians reflect the fact that placebo treatment represent a socially undesirable behaviour. We conclude that theoretical and normative analyses of the perspective of the actors ought to be supplemented by empirical research.(ABSTRACT TRUNCATED AT 250 WORDS)

Informed consent: study of quality of information given to participants in a clinical trial.

OBJECTIVE: To determine whether the participants in a clinical trial had perceived adequate information about the trial according to the guidelines of the Declaration of Helsinki. DESIGN: About 18 months after the end of a gynaecological clinical trial the participants received a questionnaire by post, which focused on the quality of the information given to them before entering the trial. Neither researchers nor participants were aware in advance that the trial would become the subject of this follow up investigation. SETTING: Eight different centres in Sweden. SUBJECTS: 43 women out of the 53 who completed the trial (mean (range) age 23 (16 to 35) years) returned the questionnaire. MAIN OUTCOME MEASURES: Adequacy of the information (based on requirements of the Declaration of Helsinki) to enable the following: understanding of the aims of the study; awareness of what participation meant; and awareness of the possibility of withdrawing from participation at any time. Motives for agreeing to participate, and a subjective evaluation of the given information were also recorded. RESULTS: All but one of the participants had been aware that they were taking part in a research project. Five women stated that they had not been aware that a second laparoscopy was performed only for research reasons. Seven women reported that they had not been aware of the meaning of participating in the project and 17 that they had had no information about the possibility of withdrawing from the study whenever they wanted. In the subjective rating 22 women considered the information given as good or very good. There was a systematic variation in the quality of the given information among the eight centres. CONCLUSION: Although all but one of the participants had been aware that they were taking part in a clinical trial, the quality of the information understood and recalled by participants varied, and in many cases clearly did not meet the guidelines of the Declaration of Helsinki. Variations among centres in participants' perception of information suggest that deficiencies in perception may be caused by informers rather than the participants.

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.