Economic evaluation of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African countries: a study protocol

Asif R Khowaja, Craig Mitton, Stirling Bryan, Laura A Magee, Zulfiqar A Bhutta, Peter von Dadelszen, Asif R Khowaja, Craig Mitton, Stirling Bryan, Laura A Magee, Zulfiqar A Bhutta, Peter von Dadelszen

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.

Discussion: 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.

Trial registration: ClinicalTrials.gov: NCT01911494.

Figures

Fig. 1
Fig. 1
Research plan for economic evaluation of the CLIP
Fig. 2
Fig. 2
Decision analytic tree model for economic evaluation of CLIP. HDP, hypertensive disorder of pregnancy
Fig. 3
Fig. 3
Map of interventional studies on the topic of maternal health—those registered with ClinicalTrials.gov

References

    1. Kassebaum NJ, Bertozzi-Villa A, Coggeshall MS, Shackelford KA, Steiner C, Heuton KR, et al. Global, regional, and national levels and causes of maternal mortality during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014;384:980–1004. doi: 10.1016/S0140-6736(14)60696-6.
    1. Osungbade KO, Ige OK. Public health perspectives of preeclampsia in developing countries: implication for health system strengthening. Journal of Pregnancy. 2011;(2011):1-6. Online: 10.1155/2011/481095. Accessed 20 May 2015.
    1. The American College of Obstetrician and Gynaecologists. Hypertension in pregnancy. Online available: . Accessed 20 May 2015.
    1. Yücesoy G, Sebiha Ö, Harika B, Temel T, Caliskan E, Vural B, et al. Maternal and perinatal outcome in pregnancies complicated with hypertensive disorder of pregnancy: a seven-year experience of a tertiary care center. Archives of gynaecology and obstetrics. 2005;273(1):43–9. doi: 10.1007/s00404-005-0741-3.
    1. Preeclampsia Foundation. Some heavy facts. Available online: Accessed 20 May 2015.
    1. von Dadelszen P, Magee LA. Pre-eclampsia: an update. Curr Hypertens Rep. 2014;16(8):454–9. doi: 10.1007/s11906-014-0454-8.
    1. Payne B, Gordon R, Vidler M. Pharmacotherapy for preeclampsia in low and middle income countries: an analysis of essential medicines lists. J OGC. 2013;35:215–23.
    1. Duley L, Gülmezoglu AM, Henderson-Smart DJ, Chou D. Magnesium sulphate and other anticonvulsants for women with pre-eclampsia. Cochrane Database Systematic Rev. 2010;11.
    1. Firoz T, Sanghvi H, Merialdi M, von Dadelszen P. Pre-eclampsia in low and middle-income countries. Clinical Obstetrics and Gynaecology. 2011;25(4):537–48.
    1. von Dadelszen P, Magee L, Payne B, Bhutta ZA. Community level interventions for pre-eclampsia. The Lancet. Available online . Accessed 12 Apr 2015.
    1. Hutcheon JA, Lee T, Magee LA. Using clinical symptoms to predict adverse maternal and perinatal outcomes in women with preeclampsia: data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study. Journal of Obstetrics Gynaecology Canada. 2011;33(8):803–9.
    1. Dunsmuir DT, Payne BA, Cloete G, Petersen CL, Gorges M, Lim J, et al. Development of mHealth applications for pre-eclampsia triage. Journal of Biomedical and Health Informatics. 2014;18(6):1857–1864. doi: 10.1109/JBHI.2014.2301156.
    1. Riaz S, Habib S, Jabeen A. Frequency of maternal mortality and morbidity in pregnancy-induced hypertension. J Ayub Med Coll Abbottabad. 2011;23(4):61–3.
    1. Rosenberg K, Sara T. Screening and surveillance of pregnancy hypertension—an economic approach to the use of daycare. Baillieres Clin Obstet Gynaecol. 1990;4(1):89–107. doi: 10.1016/S0950-3552(05)80214-7.
    1. Saftlas AF, Olson DR, Franks AL, Atrash HK, Pokras R. Epidemiology of preeclampsia and eclampsia in the United States, 1979–1986. Am J Obstet Gynecol. 1990;163(2):460–5. doi: 10.1016/0002-9378(90)91176-D.
    1. Agency for Healthcare Research and Quality. Health care utilization project data source. 2005. Online available at . Accessed 3 Mar 2015
    1. Tinker A. Safe motherhood as a social and economic investment. Paper prepared for technical consultation on safe motherhood. Colombo, Sri lanka. Washington, DC: World Bank; 1997.
    1. Jowett M. Safe motherhood interventions in low-income countries: an economic justification and evidence of cost effectiveness. Health Policy. 2000;53(3):201–28. doi: 10.1016/S0168-8510(00)00089-0.
    1. Shmueli A, Meiri H, Gonen R. Economic assessment of screening for pre‐eclampsia. Prenat Diagn. 2012;32(1):29–38. doi: 10.1002/pd.2871.
    1. NICE. Cost effectiveness of quantifying proteinuria in women with gestational hypertension. 2010. Online available at . Accessed 3 Mar 2015
    1. Simon J, Gray A, Duley L. Magpie Trial collaborative group. Cost-effectiveness of prophylactic magnesium sulphate for 9996 women with pre-eclampsia from 33 countries: economic evaluation of the magpie trial. BJOG. 2006;113(2):144–51. doi: 10.1111/j.1471-0528.2005.00785.x.
    1. Blackwell SC, Tomlinson MW, Berman S, Redman ME, Hassan SS, Berry SM, et al. The use of magnesium sulfate to prevent seizures in the pre-eclamptic gravida: a cost-effectiveness analysis. Prenat Neonatal Med. 2001;6:310–7.
    1. NICE. Cost effectiveness of aspirin compared with no aspirin in preventing pre-eclampsia in women at risk of developing pre-eclampsia. 2010. Online available at: . Accessed 20 May 2015
    1. NICE. Economic analysis of immediate birth (induction of labour) versus expectant management in women who have pre-eclampsia with mild or moderate hypertension at 34–37 weeks of gestation. 2010. Online available at . Accessed 20 May 2015
    1. Hu D, et al. The costs, benefits, and cost-effectiveness of interventions to reduce maternal morbidity and mortality in Mexico. PLoS One. 2007;2(8):750. doi: 10.1371/journal.pone.0000750.
    1. Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L, et al. Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet. 2005;365(9463):977–88. doi: 10.1016/S0140-6736(05)71088-6.
    1. Adam T, Lim SS, Mehta S, Bhutta ZA, Fogstad H, Mathai M, et al. Cost effectiveness analysis of strategies for maternal and neonatal health in developing countries. BMJ. 2005;331(7525):1107. doi: 10.1136/bmj.331.7525.1107.
    1. NICE. Cost effectiveness of automated urinalysis compared with visual urinalysis in screening for proteinuria in women with gestational hypertension. (2010). Online available at: . Accessed 20 May 2015.
    1. Günenç O, Cicek N, Gorkemli H, Celik C, Acar A, Akyurek C. The effect of methyldopa treatment on uterine, umbilical and fetal middle cerebral artery blood flows in preeclamptic patients. Archiv GynObst. 2002;266(3):141–4.
    1. von Dadelszen P, Ansermino JM, Dumont G, Hofmeyr GJ, Magee LA, Mathai M, et al. Improving maternal and perinatal outcomes in the hypertensive disorders of pregnancy: a vision of a community-focused approach. International Journal of Gynecology & Obstetrics. 2012;119:S30–S34. doi: 10.1016/j.ijgo.2012.03.012.
    1. Bhutta ZA, Ali S, Cousens S, Ali TM, Haider BA, Rizvi A, et al. Interventions to address maternal, newborn, and child survival: what difference can integrated primary health care strategies make? Lancet. 2008;372:972–89. doi: 10.1016/S0140-6736(08)61407-5.
    1. Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA task force report. Value Health. 2005;8(5):521–33. doi: 10.1111/j.1524-4733.2005.00045.x.
    1. International Society of Pharmacoeconomics and Outcome Research (ISPR). Online available at: . Accessed 20 May 2015
    1. Hawe P, Shiell A, Riley T, Gold L. Methods for exploring implementation variation and local context within a cluster randomized community intervention trial. J Epidemiology Community Health. 2004;58:788–93. doi: 10.1136/jech.2003.014415.
    1. Evans DB, et al. Achieving the millennium development goals for health: methods to assess the costs and health effects of interventions for improving health in developing countries. BMJ. Br Med J. 2005;331(7525):1137. doi: 10.1136/bmj.331.7525.1137.
    1. Freeman T. Best practice in focus group research: making sense of different views. J Adv Nurs. 2006;56(5):491–7. doi: 10.1111/j.1365-2648.2006.04043.x.
    1. Osubor KM, Fatusi AO, Chiwuzie JC. Maternal health-seeking behavior and associated factors in a rural Nigerian community. Matern Child Health J. 2006;10(2):159–69. doi: 10.1007/s10995-005-0037-z.
    1. Borghi J, Sabina N, Blum LS, Hoque ME, Ronsmans C. Household costs of healthcare during pregnancy, delivery, and the postpartum period: a case study from Matlab. Bangladesh. J Health Popul Nutr. 2006;24(4):446.
    1. Petrou S, Gray A. Economic evaluation using decision analytical modeling: design, conduct, analysis, and reporting. BMJ. 2011;342.
    1. Shillcutt S, LeFevre A, Lee A, Baqui A, Darmstadt G. RE. Modeling the years lost to disability (YLD) component to DALYs for economic evaluation of neonatal health interventions. Health Policy Plan. 2013
    1. World Health Organization . The World Health Report 2004:Changing history, annex table 3: burden of disease in DALYs by cause, sex, and mortality stratum in WHO regions, estimates for 2002. Geneva: World Health Organization; 2004.
    1. Mathers, Colin D., Doris Ma Fat, and J. T. Boerma. The global burden of disease: 2004 update. World Health Organization. 2008.
    1. LeFevre AE, Shillcutt SD, Waters HR, Haider S, El Arifeen S, Mannan I, et al. Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet. Bangladesh. Bulletin of the WHO. 2013;91(10):736–45.
    1. Sachs J. Macroeconomics and health: investing in health for economic development. Geneva: World Health Organization; 2002.
    1. Drummond M, Sculpher M. Methods for the economic evaluation of health care. Oxford: Oxford University Press; 2005.
    1. Lopez AD, Salomon JA, Ahmad O, Murray CJL, Mafat D. Life tables for 191 countries: data, methods, and results. GPE Discussion Paper Series No 9. Geneva: World Health Organization; 2001. Online available at: Accessed 20 May 2015
    1. Coale AJ, Demeny P. Regional model life tables and stable populations. New York: Academic; 1983.
    1. Lopez AD, Mathers CD, Ezzati M, and et al. Sensitivity and uncertainty analysis. In global burden of disease and risk factors estimates. World Bank. 2006. Online available at: . Accessed 20 May 2015.
    1. Mitton C, Donaldson C. Health care priority setting: principles, practice and challenges. Cost effectiveness and resource allocation. 2004;2(1):3–7. doi: 10.1186/1478-7547-2-3.
    1. Millennium development goal 5: Improve maternal health. WHO. 2014. Online available at: . Accessed 20 May 2015
    1. ClinicalTrials. Online available at: . Accessed 20 May 2015
    1. Bathala S. Delivering solutions to improve maternal health and increase access to family planning. 2013. Online available at: . Accessed 20 May 2015.

Source: PubMed

3
Abonnere