Abstract
BackgroundGlobally, hypertensive disorders of pregnancy, particularly pre-eclampsia and eclampsia, are the leading cause of maternal and neonatal mortality, and impose substantial burdens on the families of pregnant women, their communities, and healthcare systems. The Community Level Interventions for Pre-eclampsia (CLIP) Trial evaluates a package of care applied at both community and primary health centres to reduce maternal and perinatal disabilities and deaths resulting from the failure to identify and manage pre-eclampsia at the community level. Economic evaluation of health interventions can play a pivotal role in priority setting and inform policy decisions for scale-up. At present, there is a paucity of published literature on the methodology of economic evaluation of large, multi-country, community-based interventions in the area of maternal and perinatal health. This study protocol describes the application of methodology for economic evaluation of the CLIP in South Asia and Africa.MethodsA mixed-design approach i.e. cost-effectiveness analysis (CEA) and qualitative thematic analysis will be used alongside the trial to prospectively evaluate the economic impact of CLIP from a societal perspective. Data on health resource utilization, costs, and pregnancy outcomes will be collected through structured questionnaires embedded into the pregnancy surveillance, cross-sectional survey and budgetary reviews. Qualitative data will be collected through focus groups (FGs) with pregnant women, household male-decision makers, care providers, and district level health decision makers. The incremental cost-effectiveness ratio will be calculated for healthcare system and societal perspectives, taking into account the country-specific model inputs (costs and outcome) from the CLIP Trial. Emerging themes from FGs will inform the design of the model, and help to interpret findings of the CEA.DiscussionThe World Health Organization (WHO) strongly recommends cost-effective interventions as a key aspect of achieving Millennium Development Goal (MDG)-5 (i.e. 75 % reduction in maternal mortality from 1990 levels by 2015). To date, most cost-effectiveness studies in this field have focused specifically on the diagnostic and clinical management of pre-eclampsia, yet rarely on community-based interventions in low-and-middle-income countries (LMICs). This study protocol will be of interest to public health scientists and health economists undertaking community-based trials in the area of maternal and perinatal health, particularly in LMICs.Trial registrationClinicalTrials.gov: NCT01911494
Highlights
Hypertensive disorders of pregnancy, pre-eclampsia and eclampsia, are the leading cause of maternal and neonatal mortality, and impose substantial burdens on the families of pregnant women, their communities, and healthcare systems
This study found a cost per quality-adjusted life year (QALY) less than US$10,000 for screening, given the prevalence of preeclampsia at 3 % [19]
Economic evaluation of innovative health interventions can play a pivotal role in priority setting and can inform healthcare decision makers with evidence relevant to resource allocation [49]
Summary
Hypertensive disorders of pregnancy, pre-eclampsia and eclampsia, are the leading cause of maternal and neonatal mortality, and impose substantial burdens on the families of pregnant women, their communities, and healthcare systems. Hypertensive disorders of pregnancy (HDP), pre-eclampsia and eclampsia, are the leading cause of maternal and neonatal mortality and impose substantial burdens on the families of pregnant women, their communities, and healthcare systems [1, 2]. It is estimated that HDP complicates 10 million pregnancies, resulting in 76,000 maternal and 500,000 foetal/newborn deaths [5] Most of these deaths (>99 %) occur in lowand-middle-income countries (LMICs), in South Asia and Sub-Saharan Africa [6]. Thousands of women in hard-to-reach areas in resource-constrained LMICs continue to suffer severe disability or lose their lives because of delays in early identification, triage, transport and treatment—clinical processes that could feasibly be managed within a woman’s own community at the level of a primary health centre (PHC) or nearby via admission to a more central referral hospital [9]
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