Facing the Realities of Pragmatic Design Choices in Environmental Health Studies: Experiences from the Household Air Pollution Intervention Network Trial

• Type of Material: Article
• Authors: William Checkley, Johns Hopkins University; Shakir Hossen, Johns Hopkins University; Ghislaine Rosa, London School of Tropical Medicine and Hygiene; Lisa Thompson, Emory University; John P McCracken, University of Georgia; Anaite Diaz-Artiga, Universidad del Valle de Guatemala; Kalpana Balakrishnan, Sri Ramachandra Institute of Higher Education & Research; Suzanne M Simkovich, Medstar Health Research Institute; Lindsay J Underhill, Johns Hopkins University; Laura Nicolaou, Johns Hopkins University; Stella M Hartinger, Universidad Peruana Cayetano Heredia; Victor G Davila-Roman, Washington University in St. Louis; Miles A Kirby, Harvard T.H. Chan School of Public Health; Thomas Clasen, Emory University; Joshua Rosenthal, National Institutes of Health, Bethesda; Jennifer L Peel, Colorado State University
• Language: English
• Date: 2022-04-01
• Publisher: MDPI
• Publication Version: Final Published Version
• Copyright Statement: © 2022 by the authors.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.3390/ijerph19073790
• Title of Journal or Parent Work: INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH
• Volume: 19
• Issue: 7
• Grant/Funding Information: This study is funded by the U.S. National Institutes of Health (cooperative agreement UM1HL134590; Multiple Principal Investigators: Checkley, Clasen, Peel) in collaboration with the Bill & Melinda Gates Foundation (OPP1131279). Participating National Institutes of Health organizations include the National Heart, Lung and Blood Institute, National Institute of Environmental Health Sciences, National Cancer Institute, National Institute of Child Health and Human Development, Fogarty International Center, and the National Institutes of Health Common Fund. Suzanne M. Simkovich was supported by funding from the National Heart, Lung and Blood Institute (F32HL143909, K12HL137942). Lindsay J. Underhill was supported by the UMJT Fogarty Global Health Fellowship Training Grant (D43TW009340; Multiple Principal Investigators: Buekens, Checkley, Chi, Kondwani) funded by the United States National Institutes of Health through the following Institutes and Centers: Fogarty International Center; National Institute of Neurological Disorders and Stroke; National Institute of Mental Health; National Heart, Lung, and Blood Institute; and, the National Institute of Environmental Health Sciences.
• Keywords: COUNTRIES; STOVE; PRECIS-2; FUEL INTERVENTION; CARE; efficacy; Environmental Sciences & Ecology; PNEUMONIA; Life Sciences & Biomedicine; Environmental Sciences; Public, Environmental & Occupational Health; randomized trials; Science & Technology; household air pollution; effectiveness
• Research Categories: Biology, Biostatistics; Health Sciences, Epidemiology

Abstract

Objective: Household Air Pollution Intervention Network (HAPIN) investigators tested a complex, non-pharmacological intervention in four low- and middle-income countries as a strategy to mitigate household air pollution and improve health outcomes across the lifespan. Intervention households received a liquefied petroleum gas (LPG) stove, continuous fuel delivery and regular behavioral reinforcements for 18 months, whereas controls were asked to continue with usual cooking practices. While HAPIN was designed as an explanatory trial to test the efficacy of the intervention on four primary outcomes, it introduced several pragmatic aspects in its design and conduct that resemble real-life conditions. We surveyed HAPIN investigators and asked them to rank what aspects of the design and conduct they considered were more pragmatic than explanatory. Methods: We used the revised Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) to survey investigators on the degree of pragmatism in nine domains of trial design and conduct using a five-point Likert rank scale from very explanatory (1) to very pragmatic (5). We invited 103 investigators. Participants were given educational material on PRECIS-2, including presentations, papers and examples that described the use and implementation of PRECIS-2. Results: Thirty-five investigators (mean age 42 years, 51% female) participated in the survey. Overall, only 17% ranked all domains as very explanatory, with an average (±SD) rank of 3.2 ± 1.4 across domains. Fewer than 20% of investigators ranked eligibility, recruitment or setting as very explanatory. In contrast, ≥50% of investigators ranked the trial organization, delivery and adherence of the intervention and follow-up as very/rather explanatory whereas ≤17% ranked them as rather/very pragmatic. Finally, <25% of investigators ranked the relevance of outcomes to participants and analysis as very/rather explanatory whereas ≥50% ranked then as rather/very pragmatic. In-country partners were more likely to rank domains as pragmatic when compared to investigators working in central coordination (average rank 3.2 vs. 2.8, respectively; Wilcoxon rank-sum p < 0.001). Conclusion: HAPIN investigators did not consider their efficacy trial to be rather/very explanatory and reported that some aspects of the design and conduct were executed under real-world conditions; however, they also did not consider the trial to be overly pragmatic. Our analysis underscores the importance of using standardized tools such as PRECIS-2 to guide early discussions among investigators in the design of environmental health trials attempting to measure efficacy.