Evidence map›Paper›PMID 39289020›Full record

ArticleBMJ open2024

Systematic scoping review of cluster randomised trials conducted exclusively in low-income and middle-income countries between 2017 and 2022.

Cory E Goldstein, Yacine Marouf, Mira Johri, Julia F Shaw, Anand Sergeant, Stuart G Nicholls, Fernando Althabe, Rashida A Ferrand, Rieke van der Graaf, Karla Hemming and 5 more

Abstract readScoping Review
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
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

15 authors.

Cory E GoldsteinClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada cogoldstein@ohri.ca.ORCID 0000-0002-0229-5039
Yacine MaroufDalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.ORCID 0009-0005-4852-4860
Mira JohriCentre de recherche du CHUM, Montreal, Quebec, Canada.ORCID 0000-0001-5642-787X
Julia F ShawClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Anand SergeantDepartment of Medicine, Western University, London, Ontario, Canada.
Stuart G NichollsClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Fernando AlthabeInstituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina.
Rashida A FerrandFaculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
Rieke van der GraafDepartment of Bioethics and Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Karla HemmingInstitute of Applied Healthcare Research, University of Birmingham, Birmingham, UK.
Lawrence MbuagbawBiostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.ORCID 0000-0001-5855-5461
Shaun TreweekAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
Vivian A WelchBruyère Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0002-5238-7097
Charles WeijerDepartment of Medicine, Western University, London, Ontario, Canada.ORCID 0000-0002-5510-1074
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0002-3978-8961

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affiliations and primary clinical focus and to evaluate adherence to trial registration and ethics reporting requirements over time.

designA systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews. DATA SOURCES: We searched MEDLINE between 1 January 2017 and 17 August 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included primary reports of CRTs evaluating health-related interventions, conducted exclusively in LMICs and published in English between 2017 and 2022. DATA EXTRACTION AND SYNTHESIS: Data were extracted by one reviewer; a second reviewer verified accuracy by extracting data from 10% of the reports. Results were summarised overall and categorised by country's economic level or publication year.

resultsAmong 800 identified CRTs, 400 (50.0%) randomised geographical areas and 373 (46.6%) were conducted in Africa. 30 (3.7%) had no authors with an LMIC affiliation, and 246 (30.8%) had neither first nor last author with an LMIC affiliation. The relative frequency of first or last authors holding an LMIC affiliation increases as a country's economic level increases. Most CRTs focused on reducing maternal and neonatal disorders (106, 13.3%). 670 (83.8%) CRTs reported trial registration, 786 (98.2%) reported research ethics committee review and 757 (94.6%) reported consent statements. Among the 757 CRTs, 46 (6.1%) reported a waiver or no consent and, among these, 10 (21.7%) did not provide a rationale. Gatekeepers were identified in 403 (50.4%) CRTs. No meaningful trends were observed in adherence to trial registration or ethics reporting requirements over time.

conclusionOur findings suggest existing inequity in authorship practices. There is high adherence to trial registration and ethics reporting requirements, although greater attention to reporting a justification for using a waiver of consent is needed.

Indexed as

Developing CountriesRandomized Controlled Trials as TopicHumansMEDICAL ETHICSRandomized Controlled TrialSystematic Review

Identifiers

PMID39289020
PMCPMC11409340

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.