Insecticide-treated nets for the prevention of malaria in pregnancy: a systematic review of randomised controlled trials.

BACKGROUND: Protection from malaria with insecticide-treated bednets (ITNs) during pregnancy is widely advocated, but evidence of benefit has been inconsistent. We undertook a systematic review of randomised trials. METHODS AND FINDINGS: Three cluster-randomised and two individually randomised trials met the inclusion criteria; four from Africa (n = 6,418) and one from Thailand (n = 223). In Africa, ITNs compared to no nets increased mean birth weight by 55 g (95% confidence interval [CI] 21-88), reduced low birth weight by 23% (relative risk [RR] 0.77, 95% CI 0.61-0.98), and reduced miscarriages/stillbirths by 33% (RR 0.67, 0.47-0.97) in the first few pregnancies. Placental parasitaemia was reduced by 23% in all gravidae (RR 0.77, 0.66-0.90). The effects were apparent in the cluster-randomised trials and the one individually randomised trial in Africa. The trial in Thailand, which randomised individuals to ITNs or untreated nets, showed reductions in anaemia and fetal loss in all gravidae, but not reductions in clinical malaria or low birth weight. CONCLUSIONS: ITNs used throughout pregnancy or from mid-pregnancy onwards have a beneficial impact on pregnancy outcome in malaria-endemic Africa in the first few pregnancies. The potential impact of ITNs in pregnant women and their newborns in malaria regions outside Africa requires further research.

Enhanced relapse prevention for bipolar disorder--ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder.

BACKGROUND: Bipolar Disorder (BD) is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS) interventions in ways that will enhance dissemination. METHODS AND DESIGN: This article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs) in community mental health teams (CMHTs) to offer Enhanced Relapse Prevention (ERP) to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU). The main aims of the study are (1) to determine the acceptability of the intervention, training and outcome measures (2) to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3) to estimate the design effect of clustering for key outcome variables (4) to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol. DISCUSSION: This information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular cluster randomised controlled trials.

An encouraging assessment of methods to inform priorities for updating systematic reviews.

OBJECTIVE: To consider the use of statistical methods that aim to prioritize the updating of a collection of systematic reviews based on preliminary literature searches. STUDY DESIGN AND SETTING: A new simulation-based method estimating statistical power and the ratio of the weights assigned to the predicted new and old evidence, and the existing Barrowman n approach is considered. Using only information on the numbers of subjects randomized in the "new" trials, these were applied retrospectively, by removing recent studies, to existing systematic reviews from the Cochrane Infectious Diseases Group. RESULTS: Twelve systematic reviews were included. When the removed studies were reinstated, inferences changed in five of them. These reviews were ranked, in order of update priority, 1, 2, 3, 4, and 11 and 1, 2, 3, 4, and 12 by the Barrowman n and simulation-based power approaches, respectively. The low ranking of one significant meta-analysis by both methods was due to unexpectedly favorable results in the reinstated study. CONCLUSION: This study demonstrates the feasibility of the use of analytical methods to inform update prioritization strategies. Under conditions of homogeneity, Barrowman's n and simulated power were in close agreement. We encourage further, prospective, evaluation of these methods.