Prospective harmonisation of four international randomised controlled trials in Canada, China, India and South Africa: the Healthy Life Trajectories Initiative

Abstract

Objectives: the Healthy Life Trajectories Initiative (HeLTI) is an international multistudy consortium that supports the development and integration of four randomised controlled trials (RCTs) conducted in South Africa, India, China and Canada. HeLTI aims to evaluate interventions to improve the health and well-being of mothers and children, starting from preconception through pregnancy and early childhood until age 5 years. This paper describes the process by which we prospectively harmonised the participating studies and provides a descriptive analysis of the study-specific harmonisation potential.

Design: prospective harmonisation of four international RCTs.

Methods: a list of core variables to be collected across ten waves of data collection was defined. Taking this list into consideration, investigators developed country-specific questionnaires that were then assessed and adjusted to optimise the harmonisation potential across countries. As questionnaires were not identical, where required, processing scripts were generated to help transform the collected data into the core variable format.

Setting: the four RCTs are conducted in Canada, China, India and South Africa. The prospective harmonisation was led by the Maelstrom Research team in Canada.

Participants: between 4500 and 6000 women planning to get pregnant are recruited in each RCT. Women remain in the study if they become pregnant inside the planned interval of 1–3 years, depending on the country.

Results: a total of 1962 variables from questionnaires, physical measurements and biospecimen analyses were defined across 10 timepoints of data collection and 3 subpopulations (mothers, partners and children). These variables cover 47 different domains of information. For the preconception phase, following the development of questionnaires and their implementation in the data collection software, 77.2% of the core variables defined can be created across the four studies.

Conclusion: the HeLTI harmonisation process was successful, and the datasets generated represent a valuable resource allowing researchers to address a wide range of research questions on the impact of behaviour change interventions on maternal and child health indicators in different populations.

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Identifiers

ORCID for Shane A. Norris: orcid.org/0000-0001-7124-3788

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