Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial. Informing resource-poor populations and the delivery of entitled health and social services in rural India: a cluster randomized controlled trial. Fewer adverse events as a result of the SAFE or SORRY? programme in hospitals and nursing homes. part i: primary outcome of a cluster randomised trial.
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.
                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.
                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.
                Birth outcomes in a poor rural population improved greatly through a low cost, potentially sustainable and scalable, participatory intervention with women's groups. A lack of awareness about entitled health and social services may contribute to poor delivery of such services in developing countries, especially among individuals of low socioeconomic status.
                To determine the impact of informing resource-poor rural populations about entitled services.
                Community-based, cluster randomized controlled trial conducted from May 2004 to May 2005 in 105 randomly selected village clusters in Uttar Pradesh state in India. Households (548 intervention and 497 control) were selected by a systematic sampling design, including both low-caste and mid- to high-caste households.
                Four to 6 public meetings were held in each intervention village cluster to disseminate information on entitled health services, entitled education services, and village governance requirements. No intervention took place in control village clusters.
                Visits by nurse midwife; prenatal examinations, tetanus vaccinations, and prenatal supplements received by pregnant women; vaccinations received by infants; excess school fees charged; occurrence of village council meetings; and development work in villages.
                At baseline, there were no significant differences in self-reported delivery of health and social services. After 1 year, intervention villagers reported better delivery of several services compared with control villagers: in a multivariate analysis, 30% more prenatal examinations (95% confidence interval [CI], 17%-43%; P < .001), 27% more tetanus vaccinations (95% CI, 12%-41%; P < .001), 24% more prenatal supplements (95% CI, 8%-39%; P = .003), 25% more infant vaccinations (95% CI, 8%-42%; P = .004), and decreased excess school fees of 8 rupees (95% CI, 4-13 rupees; P < .001). In a difference-in-differences analysis, 21% more village council meetings were reported (95% CI, 5%-36%; P = .01). There were no improvements in visits by a nurse midwife or in development work in the villages. Both low-caste and mid- to high-caste intervention households reported significant improvements in service delivery.
                Informing resource-poor rural populations in India about entitled services enhanced the delivery of health and social services among both low- and mid- to high-caste households. Interventions that emphasize educating resource-poor populations about entitled services may improve the delivery of such services.
                clinicaltrials.gov Identifier: NCT00421291. Patient care guidelines are usually implemented one at a time, yet patients are at risk for multiple, often preventable, adverse events simultaneously.
                This study aimed to test the effect of the SAFE or SORRY? programme on the incidence of three adverse events (pressure ulcers, urinary tract infections and falls). This paper describes Part I of the study: the effect on the incidence of adverse events.
                A cluster randomised trial was conducted between September 2006 and November 2008. After a three-month baseline period the intervention was implemented followed by a nine-month follow-up period.
                Ten wards from four hospitals and ten wards from six nursing homes were stratified for institute and ward type and then randomised to intervention or usual care group.
                During baseline and follow-up, patients (≥18 years) with an expected length of stay of at least five days, were asked to participate.
                The SAFE or SORRY? programme consisted of the essential recommendations of guidelines for the three adverse events. A multifaceted implementation strategy was used for the implementation: education, patient involvement and feedback on process and outcome indicators. The usual care group continued care as usual. Data were collected on the incidence of adverse events and a Poisson regression model was used to estimate the rate ratio of the adverse events between the intervention and the usual care group at follow-up.
                At follow-up, 2201 hospital patients with 3358 patient weeks and 392 nursing home patients with 5799 patient weeks were observed. Poisson regression analyses showed a rate ratio for the development of an adverse event in favour of the intervention group of 0.57 (95% CI: 0.34-0.95) and 0.67 (95% CI: 0.48-0.99) for hospital patients and nursing home patients respectively.
                This study showed that implementing multiple guidelines simultaneously is possible, which is promising. Patients in the intervention groups developed 43% and 33% fewer adverse events compared to the usual care groups in hospitals and nursing homes respectively. Even so, more research is necessary to underline these results.
                clinicaltrials.gov, number NCT00365430.
                Copyright © 2011 Elsevier Ltd. All rights reserved.
There are no other studies from other countries other than India and Nepal and there are insufficient data on cost-effectiveness of each procedure. Better evidence is needed before any change may be implemented. Future studies need to have longer-term follow-up and be conducted to minimize biases revealed in this review with a larger sample size to allow examination of adverse events.