Evidence map›Paper›PMID 33845785›Full record

ArticleBMC medical research methodology2021

A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings.

Suzanne M Simkovich, Lisa M Thompson, Maggie L Clark, Kalpana Balakrishnan, Alejandra Bussalleu, William Checkley, Thomas Clasen, Victor G Davila-Roman, Anaite Diaz-Artiga, Ephrem Dusabimana and 14 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical research methodology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02944682 (Household Air Pollution and Health), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02944682 nacompletednot on this map

Household Air Pollution and Health: A Multi-country LPG Intervention Trial

TypeinterventionalSponsorEmory UniversityRan2017 to 2025Enrolled3,640ConditionsInfant, Low Birth WeightArmsLiquefied petroleum gas (LPG) cookstove
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Suzanne M SimkovichDivision of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, USA. suzanne.m.simkovich@medstar.net.ORCID 0000-0003-2462-0856
Lisa M ThompsonNell Hodgson Woodruff School of Nursing, Emory University, Atlanta, USA.
Maggie L ClarkDepartment of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, USA.
Kalpana BalakrishnanDepartment of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.
Alejandra BussalleuA.B. PRISMA, San Miguel, Peru.
William CheckleyDivision of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, USA.
Thomas ClasenGangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, USA.
Victor G Davila-RomanCardiovascular Division, Department of Medicine, Washington University School of Medicine, St. Louis, USA.
Anaite Diaz-ArtigaCenter for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala.
Ephrem DusabimanaEagle Research Center, Kigali, Rwanda.
Lisa de las FuentesCardiovascular Division, Department of Medicine, Washington University School of Medicine, St. Louis, USA.
Steven HarveyCenter for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, USA.
Miles A KirbyDepartment of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Amy LovvornGangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, USA.
Eric D McCollumGlobal Program for Respiratory Sciences, Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, USA.
Erick E MollinedoDepartment of Environmental Health Science, College of Public Health, University of Georgia, Athens, USA.
Jennifer L PeelDepartment of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, USA.
Ashlinn QuinnDivision of International Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, USA.
Ghislaine RosaFaculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
Lindsay J UnderhillDivision of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, USA.
Kendra N WilliamsDivision of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, USA.
Bonnie N YoungDepartment of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, USA.
Joshua RosenthalDivision of International Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, USA.
HAPIN Investigators

Funding

Household Air Pollution and Health: A Multi-Country LPG Intervention TrialUM1HL134590 · NHLBI · EMORY UNIVERSITY · PI CHECKLEY, WILLIAM, CLASEN, THOMAS F · 2016 to 2021
$31.1M
UJMT – ORWH – Gazzetta, Issa-BoubeD43TW009340 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI William Checkley, Benjamin H. Chi · 2017 to 2026
$14.8M
Washington University K12 Program in T4 Implementation ResearchK12HL137942 · NHLBI · WASHINGTON UNIVERSITY · PI DAVILA-ROMAN, VICTOR G. · 2017 to 2021
$3.1M
Cost Effectiveness Analysis of an LPG Stove and Fuel Distribution Intervention.F32HL143909 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI SIMKOVICH, SUZANNE MARIE · 2018 to 2019
$140k
FIC NIH HHS D43 TW009340FIC NIH HHS D43TW009340NHLBI NIH HHS 1F32HL143909-01NHLBI NIH HHS F32 HL143909NHLBI NIH HHS K12 HL137942NHLBI NIH HHS K12HL137942NHLBI NIH HHS UM1 HL134590
6 · The paper itself

Abstract

rationaleThe spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk.

objectivesIn the context of the multicountry Household Air Pollution Intervention (HAPIN) trial conducted in rural, low-resource settings, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize the integrity of reseach aims while minimizing infection risk based on the latest scientific understanding of the virus.

methodsWe drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework. National and local government recommendations provided the minimum safety guidelines for our work.

resultsOur framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential viral aerosolization while performing the activity. For each activity, one of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities that can potentially aerosolize the virus are deemed the highest risk.

conclusionsBy applying a systematic, procedure-specific approach to risk assessment for each trial activity, we were able to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our staff, participants, local communities, and funders. This framework can be tailored to other research studies conducted in similar settings during the current pandemic, as well as potential future outbreaks with similar transmission dynamics. The trial is registered with clinicaltrials.gov NCT02944682 on October 26. 2016 .

Indexed as

PandemicsBiomedical ResearchCommunicable Disease ControlCOVID-19HumansRandomized Controlled Trials as TopicResearch DesignRisk AssessmentBiosafetyCOVID-19ResearchRisk assessmentSARS-CoV-2

Identifiers

PMID33845785
PMCPMC8040756

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.