There is a clear need for health education and health promotion in this area. Future work should explore professionals' knowledge and views of these types of conditions with the aim of providing guidelines for management in primary care.

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Objective To explore trial participants' responses to receiving a summary of the results of a trial in pregnancy. Design Qualitative study with semistructured interviews. Participants 20 women who had when pregnant participated in the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes and requested a copy of the trial results. Results Less than a fifth of women who participated in the ORACLE trial indicated that they wished to receive the trial results. Reactions to the leaflet summarising the trial results were generally positive or neutral, although some women had difficulty in understanding the leaflet, and there was evidence of possible negative implications for women who had adverse outcomes. Women requested the results because they were interested in being able to complete their own personal narrative. They wished to know to which arm of the trial they had been allocated and the implications for their own pregnancy, and they were disappointed with receiving a generic summary. Women's accounts indicated some confusion about the trial findings. Conclusions Recommendations that research participants be routinely provided with the results of studies have been made without the benefit of research to show the consequences of doing this or how it should best be managed. Caution is needed, as is more evaluation of how feedback of results should be handled, and assessment of the risks, benefits, and costs.

Background: Randomised controlled trials of interventions in critical situations are necessary to establish safety and evaluate outcomes. Pregnant women have been identified as a potentially vulnerable population. Objective: To explore women's experiences of being recruited to ORACLE, a randomised controlled trial of antibiotics in pre-term labour. Methods: Twenty qualitative interviews were conducted with women who had participated in ORACLE. Analysis was based on the constant comparative method. Results: Women gave prominence to the socioemotional aspects of their interactions with healthcare professionals in making decisions on trial participation. Comments on the quality of written and spoken information were generally favourable, but women's accounts suggest that the stressful nature of the situation affected their ability to absorb the information. Women generally had poor understanding of trial design and practices. The main motivation for trial participation was the possibility of an improved outcome for the baby. The second and less prominent motivation was the opportunity to help others, but this was conditional on there being no risks associated with trial participation. In judging the risks of participation, women seemed to draw on ''common sense'' understandings including a perception that antibiotics were risk free. Discussion: Recruitment to trials in critical situations raises important questions. Future studies should explore how rigorous governance arrangements for trials, particularly in critical situations, can protect participants rather than relying on ideals of informed consent that may be impossible to achieve. Future research should include a focus on interactions between research candidates and professionals involved in recruitment.

Objective To examine patients' understanding of the status, function, and remit of written consent to surgery. Design Prospective questionnaire study. Questionnaires were sent to patients within one month of surgery. Responses were analysed with frequencies and single variable analyses. Setting Large teaching hospital. Participants 732 patients who had undergone surgery in obstetrics and gynaecology over a six month period. Main outcome measures Patients' awareness of the legal implications of written consent and their views on the function and remit of the consent form. Results Patients had limited understanding of the legal standing of written consent. Nearly half (46%, 95% confidence interval 43% to 50%) of patients believed the primary function of consent forms was to protect hospitals and 68% (65% to 71%) thought consent forms allowed doctors to assume control. Only 41% (37% to 44%) of patients believed consent forms made their wishes known. Conclusions Many patients seem to have limited awareness of the legal implications of signing or not signing consent forms, and they do not recognise written consent as primarily serving their interests. Current consent procedures seem inadequate as a means for the expression of autonomous choice, and their ethical standing and credibility can be called into question.