Optimising reproductive and child health outcomes by building evidence-based research and practice in South East Asia (SEA-ORCHID): study protocol

Each year there are over half a million maternal deaths worldwide and 98 percent of these occur in the developing world. This represents a tragic and striking health risk differential between the developed and developing world. For women in Asia the lifetime risk of maternal death is one in 65 compared with one in 1,800 for women in developed countries [1].

The main causes of mortality directly related to pregnancy and childbirth are unsafe abortions, bleeding, infection, hypertension (including eclampsia) and obstructed labour [2]. The majority of maternal deaths occur after the birth but many are related to conditions that present earlier in pregnancy. Serious acute and chronic maternal morbidity has been estimated to occur in one in four women [3].

Perinatal and early infant deaths are also high in developing countries. Each year there are almost eight million stillbirths and early neonatal deaths. These arise because of poor maternal health and pregnancy care. Associated morbidity manifests as low birth weight, asphyxia and infection [4].

The high rate of maternal, infant and child mortality in SE Asian countries has been associated with poverty, reduced education and literacy, lack of remunerative employment, low social status, and limited access to health services and family planning [5]. SE Asia accounts for one quarter of the world's population and more than half of the worlds poor. Solutions to these problems require an inter-sectoral approach. This has been supported by many international bodies such as the World Health Organization, World Bank, United Nations Children's Fund and United Nations Population Fund.

Access to scientifically valid and up-to-date information is a prerequisite for allocation of resources according to evidence and need. Most health workers and policy-makers in developing countries do not have easy access to the latest reliable information on effective care or may not have the skills to evaluate and implement such evidence [6].

A variety of problems arise when clinical practices that are not based on sound scientific evidence are incorporated into established healthcare practice. Valuable resources continue to be used in some developing countries to fund practices of unknown effectiveness, for example electronic fetal monitoring during labour [7]. On the other hand, interventions that have been shown to be both cheap and effective, such as magnesium sulphate to prevent and treat eclampsia, have not been widely implemented [8]. In an empirical example of clinical practice being at odds with published recommendations, a study conducted in six centres in SE Asia and two in the United States of America, demonstrated a large variation in the use of antibiotic prophylaxis in caesarean section, despite there being strong evidence supporting its use [9]. Only two of the eight participating centres routinely administered appropriate regimens of antibiotics at the appropriate time.

Clearly a mechanism is needed to provide healthcare practitioners in the developing world with access to relevant evidence, a means of determining their own evidence requirements and the infrastructure to disseminate and implement clinical practice change based on that evidence. The effects of this provision then need to be evaluated to inform future initiatives aiming to improve health care.

The Cochrane Collaboration is an international organisation of healthcare practitioners, researchers and consumers that prepares and disseminates systematic reviews of high quality evidence about the effects of healthcare interventions [10]. The growth of the Cochrane Collaboration is well known, with over 3000 reviews published since 1995 and an estimated 11,500 contributors worldwide.

However, this growth has been predominantly in the developed world, and a key objective of the Cochrane Collaboration is to ensure growth of this research activity in the developing world. The Cochrane Developing Countries Network has been established to pursue strategies for encouraging the involvement of contributors from low- and middle-income countries, both in producing reviews and in implementing their findings. In 2004, the level of developing country involvement in the Cochrane Pregnancy and Childbirth Group was modest, with 59 review authors from 11 developing countries and only eight review authors from SE Asia. In the Cochrane Neonatal Group there were 11 review authors from seven developing countries and only three of these were from SE Asia.

In a joint project between WHO, UNDP/UNFPA/WHO/World Bank Special Programme of Research Development and Research Training in Human Reproduction (HRP), South African Cochrane Centre and WHO Regional Office for Africa, the WHO Reproductive Health Library [11] derived in part from reviews in The Cochrane Library, was made available and practitioners trained in its use within South Africa [12]. Introducing a similar initiative in SE Asia, along with increasing the capacity for involvement in the Cochrane Collaboration and use of The Cochrane Library, has the potential to contribute to addressing the issues surrounding maternal mortality and morbidity.

Our project, which began in 2004, planned to build on these previous strategies and go beyond the implementation of evidence alone to assess the effect of a more far-reaching intervention of identifying evidence needs; training and support in evidence generation, synthesis and use; and provision of research infrastructure to facilitate these evidence-based practice activities.

It has been stated that providing access to reliable health information for workers in developing countries is potentially the single most cost effective and achievable strategy for sustainable improvement in health care [13]. Information provision alone however is not enough: we need to ensure that clinical practice changes in response to that information. While little is known about the best ways to change the behaviour of healthcare workers and so to implement available evidence, we do know that it is a complex process requiring access to information, skills to interpret that information and a sense of having contributed to the process. The Cochrane Collaboration has had success in the developed world in involving clinicians in the process of generating, synthesising and using evidence. The intervention in this project will draw on the experience of the past 10 years in building the Cochrane Collaboration through infrastructure provision, training, support and methodological development and will involve local researchers to ensure the intervention is regionally appropriate and designed to increase capacity within SE Asia.

In order to increase the uptake of effective treatments and stop the use of harmful ones, it is essential that healthcare communities within SE Asia are the drivers of the project. This includes promoting interventions that are locally appropriate, identifying important research questions, conducting relevant research and evidence synthesis, and training local practitioners in the implementation of research findings. It has been demonstrated that a sense of local ownership of projects and processes aiming to improve practice, including evidence generation, contributes to the success of implementing evidence [14].

In 2001, the Thai Cochrane Network, based at Khon Kaen University, became the first registered group of the Cochrane Collaboration in SE Asia and provides the ideal platform from which to launch this current initiative. To maximise the potential of this intervention we plan to build upon existing partnerships and organisations to extend current capacity [15].

The project was designed to address the following broad scientific question: Can the health of mothers and babies in Thailand, Indonesia, the Philippines and Malaysia be improved by increasing capacity for the synthesis of research, implementation of effective interventions, and identification of gaps in knowledge needing further research in those countries? The objectives of the project were intended to answer the following questions as components of the broad question:

During this phase of the study, we planned to establish three Australian support nodes and a project node within each of the four SE Asian participating countries. Under the supervision of the local SEA-ORCHID investigator, each node put in place the infrastructure to support and sustain the project. This involved purchasing equipment, employing and training staff, and seeking local ethics approval. As part of efforts to promote the project we set up a dedicated website http://​www.​seaorchid.​org that includes information about the project; a library of project materials, resources and presentations; and a secure data-entry system.

The principal activities during this phase were the collection of baseline data and the recruitment and training of staff who were delivering the intervention. Three categories of information were planned to be collected at baseline and post-intervention:

The planned intervention can be divided into the following categories with the timing of delivery according to the project schema in Table 2:

The methodology of outcome assessment was designed to duplicate that of the baseline data collection, with SE Asian fieldworkers recruited and trained to carry out the tasks overseen by the local investigators, and facilitated through a web-based data collection system.

Dissemination of results will be an integral feature of the project and we anticipate the following publications: