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. 2023 Feb 11;23(1):107.
doi: 10.1186/s12884-023-05366-2.

Harmonization of maternal balanced energy-protein supplementation studies for individual participant data (IPD) meta-analyses - finding and creating similarities in variables and data collection

Alison D Gernand  1 , Kelly Gallagher  2   3 , Nita Bhandari  4 , Patrick Kolsteren  5 , Anne Cc Lee  6   7 , Yasir Shafiq  8 , Sunita Taneja  4 , James M Tielsch  9 , Firehiwot Workneh Abate  10 , Estifanos Baye  6   7 , Yemane Berhane  10 , Ranadip Chowdhury  4 , Trenton Dailey-Chwalibóg  5 , Brenda de Kok  5 , Neeta Dhabhai  4 , Fyezah Jehan  11 , Yunhee Kang  12 , Joanne Katz  12 , Subarna Khatry  13 , Carl Lachat  5 , Sarmila Mazumder  4 , Ameer Muhammad  8 , Muhammad Imran Nisar  11 , Sitanshi Sharma  4 , Leigh A Martin  2 , Ravi Prakash Upadhyay  4 , Parul Christian  12 ; Maternal BEP Studies Harmonization Initiative
Collaborators, Affiliations

Harmonization of maternal balanced energy-protein supplementation studies for individual participant data (IPD) meta-analyses - finding and creating similarities in variables and data collection

Alison D Gernand et al. BMC Pregnancy Childbirth. .

Abstract

Background: Public health and clinical recommendations are established from systematic reviews and retrospective meta-analyses combining effect sizes, traditionally, from aggregate data and more recently, using individual participant data (IPD) of published studies. However, trials often have outcomes and other meta-data that are not defined and collected in a standardized way, making meta-analysis problematic. IPD meta-analysis can only partially fix the limitations of traditional, retrospective, aggregate meta-analysis; prospective meta-analysis further reduces the problems.

Methods: We developed an initiative including seven clinical intervention studies of balanced energy-protein (BEP) supplementation during pregnancy and/or lactation that are being conducted (or recently concluded) in Burkina Faso, Ethiopia, India, Nepal, and Pakistan to test the effect of BEP on infant and maternal outcomes. These studies were commissioned after an expert consultation that designed recommendations for a BEP product for use among pregnant and lactating women in low- and middle-income countries. The initiative goal is to harmonize variables across studies to facilitate IPD meta-analyses on closely aligned data, commonly called prospective meta-analysis. Our objective here is to describe the process of harmonizing variable definitions and prioritizing research questions. A two-day workshop of investigators, content experts, and advisors was held in February 2020 and harmonization activities continued thereafter. Efforts included a range of activities from examining protocols and data collection plans to discussing best practices within field constraints. Prior to harmonization, there were many similar outcomes and variables across studies, such as newborn anthropometry, gestational age, and stillbirth, however, definitions and protocols differed. As well, some measurements were being conducted in several but not all studies, such as food insecurity. Through the harmonization process, we came to consensus on important shared variables, particularly outcomes, added new measurements, and improved protocols across studies.

Discussion: We have fostered extensive communication between investigators from different studies, and importantly, created a large set of harmonized variable definitions within a prospective meta-analysis framework. We expect this initiative will improve reporting within each study in addition to providing opportunities for a series of IPD meta-analyses.

Keywords: Antenatal; Balanced energy-protein supplementation; IPD meta-analysis; Lactation; Maternal and neonatal outcomes; Micronutrients; Preconception; Pregnancy.

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Conflict of interest statement

We have read and understood the BMC Pregnancy and Childbirth policy on declaration of interests. All authors have been funded by the Bill & Melinda Gates Foundation. ACL received grants or contracts from NICHD and the WHO, received license to Biliruler Granted from BWH to Little Sparrows Technologies, consulting fee from WHO and Johns Hopkins University Bloomberg School of Public Health, has a patent for Biliruler, participated in the Data Safety Monitoring Board or Advisory Board for PRIMES study at the University of California San Francisco. PC worked at the BMGF from 2015 to 2019 during which the BEP trials were funded. ADG, KG, NB, PK, ACL, YS, JT, ST, RC, BDK, CL, ND, JK, SK, AM, LT, RPU, and PC obtained support from the Bill & Melinda Gates Foundation to travel to Seattle in February 2020 to participate in the meeting for this initiative. JT participated on a Data Safety Monitoring Board or Advisory Board at University of North Carolina and University of California San Francisco on studies unrelated to this manuscript. JT was a non-profit board member, unpaid, for the Helen Keller International, which may use the results of these trials, depending on the results, in their programming. JT was a non-profit board member, unpaid, for the Health Volunteers Overseas that conducts work unrelated to the topic of this manuscript.

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