Evidence map›Paper›PMID 24802561›Full record

ArticleGlobal health action2014

Considerations for preparing a randomized population health intervention trial: lessons from a South African-Canadian partnership to improve the health of health workers.

Annalee Yassi, Lyndsay Michelle O'Hara, Michelle C Engelbrecht, Kerry Uebel, Letshego Elizabeth Nophale, Elizabeth Ann Bryce, Jane A Buxton, Jacob Siegel, Jerry Malcolm Spiegel

Abstract read
In one paragraph

Article in Global health action, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Trial
  2. The Equity Tool for Valuing Global Health Partnerships.Global health, science and practice · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Annalee YassiSchool of Population and Public Health, University of British Columbia, Vancouver, Canada; annalee.yassi@ubc.ca.
Lyndsay Michelle O'HaraSchool of Population and Public Health, University of British Columbia, Vancouver, Canada.
Michelle C EngelbrechtCentre for Health Systems Research & Development, University of the Free State, Bloemfontein, South Africa.
Kerry UebelCentre for Health Systems Research & Development, University of the Free State, Bloemfontein, South Africa.
Letshego Elizabeth NophaleProvincial Occupational Health Unit, Free State Department of Health, University of the Free State, Bloemfontein, South Africa.
Elizabeth Ann BryceVancouver Coastal Health, Vancouver, Canada.
Jane A BuxtonSchool of Population and Public Health, University of British Columbia, Vancouver, Canada.
Jacob SiegelSchool of Population and Public Health, University of British Columbia, Vancouver, Canada.
Jerry Malcolm SpiegelSchool of Population and Public Health, University of British Columbia, Vancouver, Canada.

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

backgroundCommunity-based cluster-randomized controlled trials (RCTs) are increasingly being conducted to address pressing global health concerns. Preparations for clinical trials are well-described, as are the steps for multi-component health service trials. However, guidance is lacking for addressing the ethical and logistic challenges in (cluster) RCTs of population health interventions in low- and middle-income countries.

objectiveWe aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North-South partnerships.

designWe reviewed our experiences and identified key ethical and logistic issues encountered during the pre-trial phase of a recently implemented RCT. This trial aimed to improve tuberculosis (TB) and Human Immunodeficiency Virus (HIV) prevention and care for health workers by enhancing workplace assessment capability, addressing concerns about confidentiality and stigma, and providing onsite counseling, testing, and treatment. An iterative framework was used to synthesize this analysis with lessons taken from other studies.

resultsThe checklist of critical factors was grouped into eight categories: 1) Building trust and shared ownership; 2) Conducting feasibility studies throughout the process; 3) Building capacity; 4) Creating an appropriate information system; 5) Conducting pilot studies; 6) Securing stakeholder support, with a view to scale-up; 7) Continuously refining methodological rigor; and 8) Explicitly addressing all ethical issues both at the start and continuously as they arise.

conclusionResearchers should allow for the significant investment of time and resources required for successful implementation of population health RCTs within North-South collaborations, recognize the iterative nature of the process, and be prepared to revise protocols as challenges emerge.

Indexed as

Health PersonnelCanadaFeasibility StudiesHIV InfectionsHumansInternational CooperationRandomized Controlled Trials as TopicSouth AfricaTuberculosis, Pulmonarybuilding relationshipscluster-randomized controlled trialsethical issuesfeasibility studiesiterative processpilot testingpopulation healthpre-trial considerationsreceptor capacity

Identifiers

PMID24802561
PMCPMC4009485

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.