Evidence map›Paper›PMID 34027222›Full record

ArticleContemporary clinical trials communications2021

Design and execution of a public randomization ceremony to enhance stakeholder engagement within a cluster randomized trial to improve tuberculosis diagnosis in Uganda.

Tania F Reza, Talemwa Nalugwa, Mariam Nantale, Katherine Adams, Katherine Fielding, Annet Nakaweesa, Denis Oyuku, Sarah Nabwire, Johnson Musinguzi, Christopher Ojok and 10 more

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. Trial
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

20 authors.

Tania F RezaDivision of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Talemwa NalugwaUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Mariam NantaleUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Katherine AdamsImplementation Science Program, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Katherine FieldingFaculty of Epidemiology and Population Health and TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
Annet NakaweesaUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Denis OyukuUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Sarah NabwireUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Johnson MusinguziUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Christopher OjokUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Diana BabiryeUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Sara L AckermanDepartment of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.
Margaret A HandleyDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
Alex KityamuwesiUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
David W DowdyUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
David A J MooreUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
J Lucian DavisUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Stavia TuryahabweUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Achilles KatambaUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Adithya CattamanchiDivision of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.

Funding

SIngle-saMPLE tuberculosis evaluation to facilitate linkage to care: The SIMPLE TB trialR01HL130192 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CATTAMANCHI, ADITHYA · 2016 to 2020
$3.2M
NHLBI NIH HHS R01 HL130192
6 · The paper itself

Abstract

Public randomization ceremonies have been proposed as a strategy to strengthen stakeholder engagement and address concerns and misconceptions associated with trial randomization. However, there are few published examples that describe how to conduct a public randomization ceremony with meaningful stakeholder engagement or how such ceremonies impact stakeholder perceptions about randomization and the randomization process. Cluster randomization for the GeneXpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial was conducted at a public randomization ceremony attended by 70 stakeholders in Kampala, Uganda. Presentations given by the Acting Assistant Commissioner from the Uganda National Tuberculosis and Leprosy Programme and trial investigators emphasized how the trial aimed to further national TB goals, as well as how stakeholders contributed to the intervention design. The purpose and process of randomization were described using simple text and visuals. Randomization was an interactive activity that required participation of stakeholders from each trial site. A survey administered to stakeholders at the end of the ceremony suggested high comprehension of randomization (98%), trust in the randomization process (96%), and satisfaction with randomization outcomes (96%). Public randomization ceremonies should be considered more routinely to engage stakeholders in and address potential concerns about the fairness and impartiality of the randomization process for community-based trials.

Indexed as

Cluster randomized trialsPublic randomization ceremonyStakeholder engagementTrial ethicsTuberculosis

Identifiers

PMID34027222
PMCPMC8131570

What OpenQuestion holds

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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.