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The WHO antenatal care randomised controlled trial: rationale and study design.

The World Health Organisation and collaborating institutions in developing countries are conducting a multicentre randomised controlled trial to evaluate a new antenatal care (ANC) programme, consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. These activities are distributed, for practical reasons, over four visits during the course of pregnancy and are aimed at achieving predetermined goals. The study is taking place in four countries, Argentina, Cuba, Saudi Arabia and Thailand. Recruitment of study subjects started on 1 May 1996. All 53 ANC clinical units had been enrolled by December 1996. Clinics in each country were randomly allocated (cluster randomisation) to provide either the new programme or the traditional programme currently in use. Approximately 24,000 women presenting for ANC at these clinics over an average period of 18 months will have been recruited. As women attending the control clinics receive the 'best standard treatment' as currently offered in these clinics, individual informed consent is requested only from women attending the intervention clinics. Authorities of the corresponding health districts and all participating clinics have provided written institutional informed consent before randomisation. The primary outcome of the trial in relation to maternal conditions is the rate of a morbidity indicator index, defined as the presence of at least one of the following conditions for which ANC is relevant: (a) pre-eclampsia or eclampsia during pregnancy or within 24 h of delivery; (b) postpartum anaemia (haemoglobin < 90 g/L); or (c) severe urinary tract infection/pyelonephritis, defined as an episode requiring antibiotic treatment and/or hospitalisation. The primary fetal outcome is the rate of low birthweight (< 2500 g). Adverse maternal and fetal outcomes are expected for approximately 10% of the control group. Several maternal and perinatal secondary outcomes are also considered. A comprehensive cost-effectiveness analysis and women's and providers' satisfaction evaluation are performed concurrently with the trial. Health-care programmes should be rigorously evaluated by randomised controlled trials, which are feasible in developing countries and should be conducted before introducing new treatments or health interventions.

Argentina↗

Methodological considerations in the design of the WHO Antenatal Care Randomised Controlled Trial.

We discuss methodological issues arising in a recent evaluation trial of a new antenatal care programme, as sponsored by the Special Programme of Research, Development and Research Training in Human Reproduction, and WHO's Division of Reproductive Health (Technical Support). The randomisation unit for the trial is the antenatal care clinic, with 53 clinics located in four countries randomly allocated to provide either the new programme or the traditional programme currently in use. Approximately 24,000 women presenting for antenatal care over an average period of 18 months will have been recruited.

Argentina↗

Methods for economic evaluation alongside a multicentre trial in developing countries: a case study from the WHO Antenatal Care Randomised Controlled Trial.

The WHO is testing a new rationalised programme of antenatal care in a multicentre randomised trial. The motivation for this trial arose from the current uncertainty about the effectiveness of different approaches to provision of routine antenatal care. Decision makers also lack information about the costs of providing routine antenatal care and the cost-effectiveness of one programme over another. Such information will be needed before the final choice of programme can be made. The WHO trial provides an ideal opportunity to estimate and compare the incremental costs and cost-effectiveness of the new programme in four countries (Argentina, Cuba, Saudi Arabia, Thailand). A separate economic component has been organised to measure the costs of antenatal care. Methods for cost identification and measurement, and methods for economic analysis in the context of an international study are based on current recommendations for the conduct of economic evaluations alongside trials. However, several aspects require further development. In particular, this includes defining standard methods for costing in different countries; measuring women's costs of access to care; and making comparisons across international settings. The economic evaluation will also inform similar multicentre international trials and investigate issues of generalisability beyond trial settings.

Argentina↗

Conceptual bases and methodology for the evaluation of women's and providers' perception of the quality of antenatal care in the WHO Antenatal Care Randomised Controlled Trial.

In this paper, we describe the conceptual bases and methodology used to assess women's and providers' perception of the quality of antenatal care, as part of a large randomised trial in four developing countries. Information has been obtained by applying both qualitative and quantitative methodologies. The focus group discussions and in-depth interviews have contributed useful insights into the cultural milieu in which care is provided, users' and providers' expectations, and their concept of quality. Based on these findings, we developed two standardised questionnaires, one being administered to a representative sample of pregnant women (n = 1600) and the other for all care providers. In this paper we present some of the findings of the focus group discussions and in-depth interviews with women in one country as an example of the kind of information we have obtained. Women expressed their point of view concerning a reduced number of visits, type of provider, information that they get during clinical encounters and interpersonal relations with health professionals. The qualitative information, together with the data we obtain from the surveys, will highlight the aspects that will have be to considered if the new model of care is to be introduced on a routine basis.

Argentina↗

Empowering women: participatory approaches in women's health and development projects.

The authors describe the experience of NGOs (nongovernmental organizations) and community-based organizations in implementing projects aimed at improving women's health. The study included 16 projects, reflecting Australian NGO experiences in Africa, China, Southeast Asia, the Pacific, and South America. They illustrate the value of participatory approaches in determining needs and priorities, and the value of the continued involvement of women in implementation, monitoring, and evaluation. Approaches that succeeded in increasing women's access to and use of health services addressed gender issues, set realistic and achievable objectives, and recognized and enhanced the roles and status of women.

Australia↗

Health care in Nicaragua.

A two-week health study tour in Nicaragua in 1987 organized by the Health Network of the (British) Nicaragua Solidarity Campaign afforded the author of this report access to health service planning, first-hand observation of the immunization programme, and visits to centres for rehabilitation of the disabled, both from the war and civil causes. The efficacy of the low technology immunization and oral rehydration programmes is contrasted with the struggle to rehabilitate the war disabled with grossly inadequate resources.

Child↗

Participatory evaluation of counselling, medical and social services of The AIDS Support Organization (TASO) in Uganda.

The AIDS Support Organization (TASO) is an indigenous non-governmental organization (NGO) of HIV-infected and affected people in Uganda. TASO provides counselling, social support, medical and nursing care for opportunistic infections at 7 centres affiliated to district hospitals in Uganda. Between 1993 and 1994, the services provided by TASO were evaluated through a participatory approach between staff and clients. TASO counselling services helped clients and their families to cope with HIV and AIDS, with 90.4% of clients revealing their serostatus, and 57.2% reporting consistent use of condoms in the past 3 months. TASO was also the main source of medical care for clients with opportunistic infections in the last 6 months (63.8%). As a result of counselling, over half of the clients (56.9%) made plans for the future and 51.3% wished to make wills. There was a high level of acceptance of people living with HIV/AIDS (PWAs) by families (79%) and the community (76%). Care was provided to PWAs at home mainly by women (86.2%). TASO has demonstrated that individuals and their families are able to live positively with HIV/AIDS. Through counselling, medical care and material support to clients and their families, TASO has effected change in people's attitudes, knowledge and lifestyles. In particular, TASO has demonstrated a strong capacity to overcome four problems that haunt AIDS care in most places: (1) revealing one's HIV-serostatus to relevant others; (2) accepting PWAs in family and community; (3) seeking early treatment; and (4) combining prevention and care. In general, TASO has shown that specialized services to meet AIDS care needs can be added to existing health services at district levels. As a result of the participatory evaluation, a well-accepted monitoring system was established.

AIDS-Related Opportunistic Infections↗

Strategies for providing care and support to children orphaned by AIDS.

As a result of the severe HIV/AIDS epidemic in sub-Saharan countries such as Zimbabwe, where between 25-30% of the adult population are estimated to be infected, there are a growing number of orphans requiring care and support. Traditionally, orphans have been absorbed within the extended family but this is becoming more difficult because of the large number of young adults dying. The burden of care and support is falling on the very young and the very old. A number of strategies have been introduced to provide this care and support. Institutions, though popular, are very expensive to run, have limited capacity and only really cater for physical needs. Interventions which simply react to those who present to them may not reach the most needy and may encourage dependency. Community-based orphan care has been identified as the best and most cost-effective way of caring for orphans. An example of a community-based orphan visiting programme is presented. In the last six months of 1996, the FOCUS programme's 88 volunteers made a total of 9,634 visits to 3,192 orphans in 798 families at an average cost of US+1.55 per visit. The key elements of such programmes have been identified. They need to be implemented by a community-based organization (CBO) within a defined community. Volunteers should be selected from within the community. They need to be trained and supported as they enumerate orphans, identify the most needy and carry out regular visits. The volunteers should keep records of all their activities. These records can then be used as a basis for monitoring the programme. In order to cope with the increasing number of orphans in resource-poor settings like Zimbabwe, it is essential that such programmes be replicated and scaled up. This not only an economic necessity but is also a way of providing appropriate and effective services to those who need them.

Child↗

The control of measles in tropical Africa: a review of past and present efforts.

Measles in tropical Africa is endemic and cyclical, with a high incidence that usually peaks during the dry seasons. Measles may be a contributing factor in 10% of all deaths among African children. Several problems have hindered measles immunization programs in Africa; these include difficulties in maintaining the cold chain, poor epidemiologic surveillance, and the logistical problems involved in reaching a population that is 80% rural. The United States Agency for International Development and the World Health Organization both have programs that are helping to increase immunization coverage and to solve the problems just mentioned. Many countries have begun to train their own personnel to administer immunization programs. However, because of limited staff and equipment, a high birth rate, and an uncertain social situation, no firm predictions can be made concerning the permanent control of measles in tropical Africa.

Africa↗

The control of endemic treponematoses.

In the 1950s and 1960s, following a decision by the Second World Health Assembly in 1949, mass treatment campaigns against the endemic treponematoses were undertaken with the support of the World Health Organization and the United Nations Children's Fund. The control policy was based on recognition of the importance of screening at least 90% of the target population; of conducting periodic resurveys and treating missed, new, and imported cases; of treating the entire treponemal reservoir (including latent cases and contacts); and of using adequate dosages of long-acting penicillin (minimal dosages were recommended). Later, policies on the extent of contact treatment at different levels of endemicity were established. During these mass campaigns, approximately 50 million clinical and latent cases and contacts were treated; prevalence of endemic treponematoses was reduced dramatically. The major reasons for resurgence of yaws and endemic syphilis in some areas are discussed. One important factor has been the failure of many countries to integrate active control measures into local health services after the mass campaigns. Yaws and pinta are continuing to decline to very low levels in the Americas. In West Africa, especially, incidence of yaws and endemic syphilis have returned to high levels. Few significant endemic areas remain in Asia except in Indonesia and Papua New Guinea.

Developing Countries↗