Health management committee strengthening and community mobilisation through women's groups to improve trained health worker attendance at birth in rural Nepal: a cluster randomised controlled trial.

BACKGROUND: Engaging citizens and communities to make services accountable is vital to achieving health development goals. Community participation in health management committees can increase public accountability of health services. We conducted a cluster randomised controlled trial to test the impact of strengthened health management committees (HMCs) and community mobilisation through women's groups on institutional deliveries and deliveries by trained health workers in rural Nepal. METHODS: The study was conducted in all Village Development Committee clusters in the hills district of Makwanpur (population of 420,500). In 21 intervention clusters, we conducted three-day workshops with HMCs to improve their capacity for planning and action and supported female community health volunteers to run women's groups. These groups met once a month and mobilised communities to address barriers to institutional delivery through participatory learning and action cycles. We compared this intervention with 22 control clusters. Prospective surveillance from October 2010 to the end of September 2012 captured complete data on 13,721 deliveries in intervention and control areas. Analysis was by intention to treat. RESULTS: The women's group intervention was implemented as intended, but we were unable to support HMCs as planned because many did not meet regularly. The activities of community based organisations were systematically targeted at control clusters, which meant that there were no true 'control' clusters. 39% (5403) of deliveries were in health institutions and trained health workers attended most of them. There were no differences between trial arms in institutional delivery uptake (1.45, 0.76-2.78) or attendance by trained health workers (OR 1.43, 95% CI 0.74-2.74). CONCLUSIONS: The absence of a true counterfactual and inadequate coverage of the HMC strengthening intervention impedes our ability to draw conclusions. Further research is needed to test the effectiveness of strengthening public accountability mechanisms on increased utilisation of services at delivery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN99834806. Date of registration:28/09/10.

Collecting and analysing cost data for complex public health trials: reflections on practice.

BACKGROUND: Current guidelines for the conduct of cost-effectiveness analysis (CEA) are mainly applicable to facility-based interventions in high-income settings. Differences in the unit of analysis and the high cost of data collection can make these guidelines challenging to follow within public health trials in low- and middle- income settings. OBJECTIVE: This paper reflects on the challenges experienced within our own work and proposes solutions that may be useful to others attempting to collect, analyse, and compare cost data between public health research sites in low- and middle- income countries. DESIGN: We describe the generally accepted methods (norms) for collecting and analysing cost data in a single-site trial from the provider perspective. We then describe our own experience applying these methods within eight comparable cluster randomised, controlled, trials. We describe the strategies used to maximise adherence to the norm, highlight ways in which we deviated from the norm, and reflect on the learning and limitations that resulted. RESULTS: When the expenses incurred by a number of small research sites are used to estimate the cost-effectiveness of delivering an intervention on a national scale, then deciding which expenses constitute 'start-up' costs will be a nontrivial decision that may differ among sites. Similarly, the decision to include or exclude research or monitoring and evaluation costs can have a significant impact on the findings. We separated out research costs and argued that monitoring and evaluation costs should be reported as part of the total trial cost. The human resource constraints that we experienced are also likely to be common to other trials. As we did not have an economist in each site, we collaborated with key personnel at each site who were trained to use a standardised cost collection tool. This approach both accommodated our resource constraints and served as a knowledge sharing and capacity building process within the research teams. CONCLUSIONS: Given the practical reality of conducting randomised, controlled trials of public health interventions in low- and middle- income countries, it is not always possible to adhere to prescribed guidelines for the analysis of cost effectiveness. Compromises are frequently required as researchers seek a pragmatic balance between rigor and feasibility. There is no single solution to this tension but researchers are encouraged to be mindful of the limitations that accompany compromise, whilst being reassured that meaningful analyses can still be conducted with the resulting data.

Economic assessment of a women's group intervention to improve birth outcomes in rural Nepal.

We did a cost-effectiveness analysis alongside a cluster-randomised controlled trial of a participatory intervention with women's groups to improve birth outcomes in rural Nepal. The average provider cost of the women's group intervention was US0.75 dollars per person per year (0.90 dollars with health-service strengthening) in a population of 86,704. The incremental cost per life-year saved (LYS) was 211 dollars (251 dollars), and expansion could rationalise on start-up costs and technical assistance, reducing the cost per LYS to 138 dollars (179 dollars). Sensitivity analysis showed a variation from 83 dollars to 263 dollars per LYS for most variables. This intervention could provide a cost-effective way of reducing neonatal deaths.

Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial.

BACKGROUND: Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years. 90% of deliveries in the poorest quintile of households happen at home. We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates. METHODS: We pair-matched 42 geopolitical clusters in Makwanpur district, Nepal, selected 12 pairs randomly, and randomly assigned one of each pair to intervention or control. In each intervention cluster (average population 7000), a female facilitator convened nine women's group meetings every month. The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them. We monitored birth outcomes in a cohort of 28?931 women, of whom 8% joined the groups. The primary outcome was neonatal mortality rate. Other outcomes included stillbirths and maternal deaths, uptake of antenatal and delivery services, home care practices, infant morbidity, and health-care seeking. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN31137309. FINDINGS: From 2001 to 2003, the neonatal mortality rate was 26.2 per 1000 (76 deaths per 2899 livebirths) in intervention clusters compared with 36.9 per 1000 (119 deaths per 3226 livebirths) in controls (adjusted odds ratio 0.70 [95% CI 0.53-0.94]). Stillbirth rates were similar in both groups. The maternal mortality ratio was 69 per 100000 (two deaths per 2899 livebirths) in intervention clusters compared with 341 per 100000 (11 deaths per 3226 livebirths) in control clusters (0.22 [0.05-0.90]). Women in intervention clusters were more likely to have antenatal care, institutional delivery, trained birth attendance, and hygienic care than were controls. INTERPRETATION: Birth outcomes in a poor rural population improved greatly through a low cost, potentially sustainable and scalable, participatory intervention with women's groups.