Universidad Peruana Cayetano Heredia

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

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dc.contributor.author Checkley, W.
dc.contributor.author Hossen, S.
dc.contributor.author Rosa, G.
dc.contributor.author Thompson, L.M.
dc.contributor.author McCracken, J.P.
dc.contributor.author Diaz-Artiga, A.
dc.contributor.author Balakrishnan, K.
dc.contributor.author Simkovich, S.M.
dc.contributor.author Underhill, L.J.
dc.contributor.author Nicolaou, L.
dc.contributor.author Hartinger Peña, Stella Maria
dc.contributor.author Davila-Roman, V.G.
dc.contributor.author Kirby, M.A.
dc.contributor.author Clasen, T.F.
dc.contributor.author Rosenthal, J.
dc.contributor.author Peel, J.L.
dc.date.accessioned 2022-06-25T20:36:42Z
dc.date.available 2022-06-25T20:36:42Z
dc.date.issued 2022
dc.identifier.uri https://hdl.handle.net/20.500.12866/11857
dc.description.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. en_US
dc.language.iso eng
dc.publisher MDPI
dc.relation.ispartofseries International Journal of Environmental Research and Public Health
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject household air pollution en_US
dc.subject randomized trials en_US
dc.subject efficacy en_US
dc.subject effectiveness en_US
dc.title Facing the Realities of Pragmatic Design Choices in Environmental Health Studies: Experiences from the Household Air Pollution Intervention Network Trial en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.3390/ijerph19073790
dc.relation.issn 1660-4601


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