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Original research
Economic and cost-effectiveness analysis of the Community-Level Interventions for Pre-eclampsia (CLIP) trials in India, Pakistan and Mozambique
  1. Jeffrey N Bone1,
  2. Asif R Khowaja2,
  3. Marianne Vidler1,
  4. Beth A Payne2,
  5. Mrutyunjaya B Bellad3,
  6. Shivaprasad S Goudar3,
  7. Ashalata A Mallapur4,
  8. Khatia Munguambe5,
  9. Rahat N Qureshi6,
  10. Charfudin Sacoor5,
  11. Esperanca Sevene5,7,
  12. Geert W J Frederix8,
  13. Zulfiqar A Bhutta6,9,
  14. Craig Mitton2,
  15. Laura A Magee1,10,
  16. Peter von Dadelszen1,10
  17. On behalf of the CLIP Trials Working Group
  1. 1Department of Obstetrics and Gynaecology, The University of British Columbia, Vancouver, British Columbia, Canada
  2. 2School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada
  3. 3Women’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research, Belgaum, Karnataka, India
  4. 4S Nijalingappa Medical College and HSK Hospital and Research Centre, Bagalkot, Karnataka, India
  5. 5Centro de Investigação em Saúde de Manhiça, Manhiça, Maputo, Mozambique
  6. 6Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan
  7. 7Universidade Eduardo Mondlane, Maputo, Mozambique
  8. 8Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands
  9. 9Centre for Global Child Health, Hospital for Sick Children, Toronto, Ontario, Canada
  10. 10Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK
  1. Correspondence to Professor Peter von Dadelszen; PVD{at}kcl.ac.uk

Abstract

Background The Community-Level Interventions for Pre-eclampsia (CLIP) trials (NCT01911494) in India, Pakistan and Mozambique (February 2014–2017) involved community engagement and task sharing with community health workers for triage and initial treatment of pregnancy hypertension. Maternal and perinatal mortality was less frequent among women who received ≥8 CLIP contacts. The aim of this analysis was to assess the incremental costs and cost-effectiveness of the CLIP intervention overall in comparison to standard of care, and by PIERS (Pre-eclampsia Integrated Estimate of RiSk) On the Move (POM) mobile health application visit frequency.

Methods Included were all women enrolled in the three CLIP trials who had delivered with known outcomes by trial end. According to the number of POM-guided home contacts received (0, 1–3, 4–7, ≥8), costs were collected from annual budgets and spending receipts, with inclusion of family opportunity costs in Pakistan. A decision tree model was built to determine the cost-effectiveness of the intervention (vs usual care), based on the primary clinical endpoint of years of life lost (YLL) for mothers and infants. A probabilistic sensitivity analysis was used to assess uncertainty in the cost and clinical outcomes.

Results The incremental per pregnancy cost of the intervention was US$12.66 (India), US$11.51 (Pakistan) and US$13.26 (Mozambique). As implemented, the intervention was not cost-effective due largely to minimal differences in YLL between arms. However, among women who received ≥8 CLIP contacts (four in Pakistan), the probability of health system and family (Pakistan) cost-effectiveness was ≥80% (all countries).

Conclusion The intervention was likely to be cost-effective for women receiving ≥8 contacts in Mozambique and India, and ≥4 in Pakistan, supporting WHO guidance on antenatal contact frequency.

Trial registration number NCT01911494.

  • health economics
  • maternal health
  • obstetrics
  • hypertension
  • intervention study

Data availability statement

Data are available upon request. As per the Statistical Analysis Plan (SAP), following publication of the primary CLIP manuscripts, and individual participant data meta-analysis, the data will be freely available to academically active entities (eg, universities, NGOs, multilaterals), with the CLIP principal investigator (PvD) or named delegate as a named coinvestigator, for the purposes of pregnancy-related research and within the limits of the informed consent obtained. Access will be through the CLIP Trials Data Access Committee*, contacted at ‘PRE-EMPT@cw.bc.ca’, as referenced on our website at ‘https://PRE-EMPT.obgyn.ubc.ca’. A copy of the data will also be deposited with our funder, the Bill & Melinda Gates Foundation, in the HBGDki repository.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjgh-2020-004123

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    Data availability statement

    Data are available upon request. As per the Statistical Analysis Plan (SAP), following publication of the primary CLIP manuscripts, and individual participant data meta-analysis, the data will be freely available to academically active entities (eg, universities, NGOs, multilaterals), with the CLIP principal investigator (PvD) or named delegate as a named coinvestigator, for the purposes of pregnancy-related research and within the limits of the informed consent obtained. Access will be through the CLIP Trials Data Access Committee*, contacted at ‘PRE-EMPT@cw.bc.ca’, as referenced on our website at ‘https://PRE-EMPT.obgyn.ubc.ca’. A copy of the data will also be deposited with our funder, the Bill & Melinda Gates Foundation, in the HBGDki repository.

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    Footnotes

    • LAM and PvD are joint senior authors.

    • Handling editor Edwine Barasa

    • Contributors PvD designed the concept of the CLIP trials. ZAB and LAM were the coprincipal investigators of the overall CLIP trials project. MBB, ZAB, SSG, AAM, RNQ, KM, CS and ES were coprincipal investigators of the individual CLIP trials. BAP and MV coordinated the CLIP trials. JNB conducted the analysis and wrote the first draft of the manuscript. The analysis plan was conceived by JNB, ARK, CM and GWJF. All authors read and approved the final version of the manuscript.

    • Funding The University of British Columbia, a grantee of the Bill & Melinda Gates Foundation (OPP1017337).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.