Consistency in decision making by research ethics committees: a controlled comparison.

There has been longstanding interest in the consistency of decisions made by research ethics committees (RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of kappa = 0.286 (95% confidence interval -0.06 to 0.73), indicating a level of agreement that, although probably better than chance, may be described as "slight". The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed.

Participating in a trial in a critical situation: a qualitative study in pregnancy.

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.

Choosing and using services for sexual health: a qualitative study of women's views.

OBJECTIVE: To explore women's accounts of choosing and using specialist services for sexual health. METHODS: A qualitative study involving semistructured interviews with 37 women screened for Chlamydia trachomatis attending genitourinary medicine and family planning clinics in an East Midlands health authority. RESULTS: In making the decision to seek help, women act on a range of specific prompts, including lay ideas about the significance of symptoms; their own behaviour; their partner's symptoms or behaviour; contact tracing; and health promotion. Some women do not seek help specifically in relation to sexual health but are identified as being at risk of sexually transmitted infections (STIs) during routine consultations. Important influences on women's choice of services include the lay referral system, "insider" knowledge of health services, referral by health professionals, and need to have alternatives to general practice care. Women's willingness to access services is mediated by psychosocial factors such as embarrassment. They may use smear tests as a legitimate opportunity to raise questions about sexual health. Women's priorities for services are that their feelings of stigma and embarrassment are managed appropriately; that staff communicate well and are sensitive to their emotions and comfort during tests and procedures; that they are "in control" when obtaining test results; and that confidentiality is preserved. CONCLUSIONS: A detailed understanding of both lay people's response to symptoms or behaviour that indicates risk of an STI and their needs when using services should inform interventions aimed at encouraging secondary prevention of STIs.

Women's experiences of giving birth after 35.

BACKGROUND: This research forms part of a longitudinal study comparing experiences of pregnancy, birth, and the first year of motherhood among women aged 35 years and over with women aged 20 to 29 years, in the light of the current trend toward later childbearing. METHODS: Data from 107 women were collected from medical records of labor and delivery, and women themselves evaluated control and pain management in labor, satisfaction with support from professionals, labor problems, and postnatal depression. Associations between maternal age and parity and 1) obstetric outcomes, 2) women's perceptions of labor and delivery, and 3) postnatal depression were calculated. RESULTS: Professionals were more likely to place women over 35 years than those aged 20 to 29 years in a "high-risk" category, but medical records of labor and delivery revealed few maternal age effects. Older mothers were more likely than younger mothers to acknowledge that their baby's life might have been at risk during labor, and that they felt happy about the way staff managed labor problems. They were less likely than younger mothers to blame others for making labor pain worse. CONCLUSIONS: Older and younger women's experiences of labor differed in ways that were not mirrored by obstetric differences. Women over 35 years, even if healthy, may believe that their age makes their infants particularly vulnerable during labor. Their higher levels of concern do not necessarily have negative consequences for their experience of childbirth or for their postnatal emotional well-being.