Hospital ethics approval for a population-based case-control study of very preterm birth.

AIM: To describe the process involved in obtaining ethics approval for a study aiming to recruit women from all maternity hospitals in Victoria, Australia. DESIGN: Observational data of the application process involving 85 hospitals throughout Victoria in 2001. RESULTS: Twenty-three of the 85 hospitals had a Human Research Ethics Committee (HREC) constituted in accordance with the National Health and Medical Council requirements; 27 agreed to accept decisions from other hospitals having HRECs and 27 relied on ethics advisory committees, hospital managers, clinical staff, quality assurance committees or lawyers for ethics decisions. Four of the latter did not approve the study. Eight hospitals no longer provided maternity services in the recruitment period. The process took 16 months, 26,000 sheets of paper, 258 copies of the application and the cost was about $30,000. Approval was eventually obtained for recruitment at 73 hospitals. DISCUSSION: Difficulties exist in obtaining timely ethics approval for multicentre studies due to a complex uncoordinated system. All hospitals should have explicit protocols for dealing with research ethics applications so that they can be processed in a straightforward and timely manner. To facilitate this, those without properly constituted HRECs should be affiliated with one hospital that has an HREC.

Maternal health study: a prospective cohort study of nulliparous women recruited in early pregnancy.

BACKGROUND: In the first year after childbirth, 94% of women experience one or more major health problems (urinary incontinence, faecal incontinence, perineal pain, back pain). Difficulties in intimate partner relationships and changes affecting sexual health are also common. The aim of this study is to investigate changes in women's health from early pregnancy until four years after the birth of a first child. METHODS/DESIGN: The Maternal Health Study is a longitudinal study designed to fill in some of the gaps in current research evidence regarding women's physical and psychological health and recovery after childbirth. A prospective pregnancy cohort of >1500 nulliparous women has been recruited in early pregnancy at six metropolitan public hospitals in Melbourne, Australia between April 2003 and December 2005. In the first phase of the study participants are being followed up at 30-32 weeks gestation in pregnancy, and at three, six, nine, 12 and 18 months postpartum using a combination of self-administered questionnaires and telephone interviews. Women consenting to extended follow-up (phase 2) will be followed up six and 12 months after any subsequent births and when their first child is four years old. Study instruments incorporate assessment of the frequency and severity of urinary and bowel symptoms, sexual health issues, perineal and abdominal pain, depression and intimate partner violence. Pregnancy and birth outcome data will be obtained by review of hospital case notes. DISCUSSION: Features of the study which distinguish it from prior research include: the capacity to identify incident cases of morbidity and clustering of health problems; a large enough sample to detect clinically important differences in maternal health outcomes associated with the method of birth; careful exposure measurement involving manual abstraction of data from medical records in order to explore mediating factors and possible causal pathways; and use of a variety of strategies to improve ascertainment of health outcomes.

Concern about tall stature during adolescence and depression in later life.

OBJECTIVE: This retrospective cohort study aimed to examine the long-term psychosocial outcomes for women assessed or treated during adolescence for tall stature. METHOD: Women assessed or treated for tall stature identified from the records of Australian paediatricians were eligible to participate. Psychosocial outcomes were measured using the depression, mania and eating disorders modules of the Composite International Diagnostic Interview (CIDI), the SF-36, and an index of social support. RESULTS: There was no significant difference between treated and untreated women in the prevalence of 12 month or lifetime major depression, eating disorders, scores on the SF-36 mental health summary scale, or the index of social support. However, compared with the findings of population-based studies, the prevalence of major depression in both treated and untreated tall girls was high (12 month prevalence: untreated 10.7%, treated 11.2%; lifetime prevalence: untreated 29.4%, treated 26.6%). Factors significantly associated with lifetime major depression in this study were self-reported difficulties during adolescence being the reason for seeking a medical assessment of height (OR 2.25, 95% CI 1.4-3.6) and a negative experience of the assessment or treatment procedures (OR 2.04, 95% CI 1.4-3.0). CONCLUSION: Long-term follow-up of a large cohort of tall girls showed that psychological outcomes among both treated and untreated women were poor and that the intended psychosocial benefit of treatment may not have been realized. The findings highlight the importance of attending to the mental health of adolescents presenting for management of conditions where self-concept and body image are a primary focus.