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

William Checkley, Shakir Hossen, Ghislaine Rosa, Lisa M. Thompson, John P. McCracken, Anaite Diaz-Artiga, Kalpana Balakrishnan, Suzanne M. Simkovich, Lindsay J. Underhill, Laura Nicolaou, Stella M. Hartinger, Victor G. Davila-Roman, Miles A. Kirby, Thomas F. Clasen, Joshua Rosenthal, Jennifer L. Peel and on behalf of Household Air Pollution Intervention Network (HAPIN) Investigators
Additional contact information
William Checkley: Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD 21287, USA
Shakir Hossen: Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD 21287, USA
Ghislaine Rosa: Faculty of Infectious and Tropical Diseases, London School of Tropical Medicine and Hygiene, London WC1E 7HT, UK
Lisa M. Thompson: Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA 30332, USA
John P. McCracken: Epidemiology and Biostatistics Department, University of Georgia, Athens, GA 30606, USA
Anaite Diaz-Artiga: Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City 01015, Guatemala
Kalpana Balakrishnan: ICMR Center for Advanced Research on Air Quality, Climate and Health, Department of Environmental Health Engineering, Sri Ramachandra Institute for Higher Education and Research, Chennai 600116, India
Suzanne M. Simkovich: Division of Healthcare Delivery Research, Medstar Health Research Institute, Hyattsville, MD 20782, USA
Lindsay J. Underhill: Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD 21287, USA
Laura Nicolaou: Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD 21287, USA
Stella M. Hartinger: Latin American Center of Excellence on Climate Change and Health, Universidad Peruana Cayetano Heredia, Lima 15102, Peru
Victor G. Davila-Roman: Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Department of Medicine, Washington University in St. Louis, St. Louis, MO 63110, USA
Miles A. Kirby: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA
Thomas F. Clasen: Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA
Joshua Rosenthal: Fogarty International Center, National Institutes of Health, Bethesda, MD 20892, USA
Jennifer L. Peel: Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO 80523, USA
on behalf of Household Air Pollution Intervention Network (HAPIN) Investigators: Mermbeship of the HAPIN investigators is provided in the acknowelegement.

IJERPH, 2022, vol. 19, issue 7, 1-12

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.

Keywords: household air pollution; randomized trials; efficacy; effectiveness (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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