Facing the Realities of Pragmatic Design Choices in Environmental Health Studies: Experiences from the Household Air Pollution Intervention Network Trial. (Record no. 677)

MARC details
000 -LEADER
fixed length control field 04465nam a22004577a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 220511s20222022 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1660-4601
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.3390/ijerph19073790 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code ijerph19073790 [pii]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code PMC8997769 [pmc]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 35409475
245 ## - TITLE STATEMENT
Title Facing the Realities of Pragmatic Design Choices in Environmental Health Studies: Experiences from the Household Air Pollution Intervention Network Trial.
251 ## - Source
Source International Journal of Environmental Research & Public Health [Electronic Resource]. 19(7), 2022 Mar 23.
252 ## - Abbreviated Source
Abbreviated source Int J Environ Res Public Health. 19(7), 2022 Mar 23.
253 ## - Journal Name
Journal name International journal of environmental research and public health
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2022
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2022
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Publication date 2022 Mar 23
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status epublish
266 ## - Date added to catalog
Date added to catalog 2022-05-11
520 ## - SUMMARY, ETC.
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.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Air Pollution
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Household Articles
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adult
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Environmental Health
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Family Characteristics
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Male
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Research Design
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Health Research Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Clinical Trial
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
657 ## - INDEX TERM--FUNCTION
Medline publication type Multicenter Study
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Simkovich, Suzanne M
790 ## - Authors
All authors Balakrishnan K, Checkley W, Clasen TF, Davila-Roman VG, Diaz-Artiga A, Hartinger SM, Hossen S, Kirby MA, McCracken JP, Nicolaou L, On Behalf Of Household Air Pollution Intervention Network Hapin Investigators, Peel JL, Rosa G, Rosenthal J, Simkovich SM, Thompson LM, Underhill LJ
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.3390/ijerph19073790">https://dx.doi.org/10.3390/ijerph19073790</a>
Public note https://dx.doi.org/10.3390/ijerph19073790
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 05/11/2022   35409475 35409475 05/11/2022 05/11/2022 Journal Article

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