title: Economic evaluation of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African countries: a study protocol.
abstract: BACKGROUND
  Globally, 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.
  
  
  METHODS
  A 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01911494.
authors.affiliation: Department of Obstetrics and Gynaecology; and Child and Family Research Institute, University of British Columbia, Vancouver, Canada. araza@cw.bc.ca.|Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, Canada. araza@cw.bc.ca.|Division of Women and Child Health, Aga Khan University, Karachi, Pakistan. araza@cw.bc.ca.
authors.forename: Asif R
authors.initials: AR
authors.lastname: Khowaja
authors.affiliation: School of Population and Public Health, University of British Columbia, Vancouver, Canada. craig.mitton@ubc.ca.|Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, Canada. craig.mitton@ubc.ca.
authors.forename: Craig
authors.initials: C
authors.lastname: Mitton
authors.affiliation: School of Population and Public Health, University of British Columbia, Vancouver, Canada. stirling.bryan@ubc.ca.|Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, Canada. stirling.bryan@ubc.ca.
authors.forename: Stirling
authors.initials: S
authors.lastname: Bryan
authors.affiliation: Department of Obstetrics and Gynaecology; and Child and Family Research Institute, University of British Columbia, Vancouver, Canada. lmagee@cw.bc.ca.
authors.forename: Laura A
authors.initials: LA
authors.lastname: Magee
authors.affiliation: Division of Women and Child Health, Aga Khan University, Karachi, Pakistan. zulfiqar.bhutta@sickkids.ca.|Centre for Global Child Health, Hospital for Sick Children, University of Toronto, Toronto, Canada. zulfiqar.bhutta@sickkids.ca.
authors.forename: Zulfiqar A
authors.initials: ZA
authors.lastname: Bhutta
authors.affiliation: Department of Obstetrics and Gynaecology; and Child and Family Research Institute, University of British Columbia, Vancouver, Canada. pdadelszen@cw.bc.ca.
authors.forename: Peter
authors.initials: P
authors.lastname: von Dadelszen
mesh_terms: D000349:Africa; D001208:Asia; D003153:Community Health Services / Q000191:economics / Q000458:organization & administration*; D003256:Community Participation; D003362:Cost-Benefit Analysis; D003430:Cross-Sectional Studies; D003906:Developing Countries; D005260:Female; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D008297:Male; D000068101:Maternal-Child Health Services / Q000458:organization & administration; D009017:Morbidity; D009026:Mortality; D011225:Pre-Eclampsia / Q000628:therapy*; D011247:Pregnancy; D011256:Pregnancy Outcome; D012107:Research Design; D012111:Residence Characteristics; D019035:Rural Health Services / Q000191:economics / Q000458:organization & administration*; D014944:World Health Organization