Evidence map›Paper›PMID 36303153›Full record

ArticleBMC medicine2022

Heterogeneity in pragmatic randomised trials: sources and management.

Bruno Giraudeau, Agnès Caille, Sandra M Eldridge, Charles Weijer, Merrick Zwarenstein, Monica Taljaard

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
–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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  10. Thinking as Relational Process and Pattern in Semiotic Cultural Psychology.Integrative psychological & behavioral science · 2026
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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

6 authors.

Bruno GiraudeauUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, 2 Bd Tonnellé, 37044, Tours cedex 9, France. bruno.giraudeau@univ-tours.fr.ORCID 0000-0003-3031-8258
Agnès CailleUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, 2 Bd Tonnellé, 37044, Tours cedex 9, France.
Sandra M EldridgeCentre for Primary Care and Public Health, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.
Charles WeijerDepartments of Medicine and Philosophy, Western University, Stevenson Hall 4130, 1151 Richmond Street, London, ON, N6A 5B7, Canada.
Merrick ZwarensteinCentre for Studies in Family Medicine, Department of Family Medicine Schulich School of Medicine & Dentistry Western University, 1151 Richmond Street, London, ON, N6A 3K7, Canada.
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, Ontario, K1Y 4E9, Canada.

Funding

Training Core (I)U54AG063546 · NIA · BROWN UNIVERSITY · PI JASON H KARLAWISH · 2019 to 2026
$125.9M
6 · The paper itself

Abstract

backgroundPragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions. Heterogeneity in patient characteristics contributes to heterogeneity in their response to the intervention. However, there are many other sources of heterogeneity in outcomes. Based on the expertise and judgements of the authors, we identify different sources of clinical and methodological heterogeneity, which translate into heterogeneity in patient responses-some we consider as desirable and some as undesirable. For each of them, we discuss and, using real-world trial examples, illustrate how heterogeneity should be managed over the whole course of the trial. MAIN TEXT: Heterogeneity in centres and patients should be welcomed rather than limited. Interventions can be flexible or tailored and control interventions are expected to reflect usual care, avoiding use of a placebo. Co-interventions should be allowed; adherence should not be enforced. All these elements introduce heterogeneity in interventions (experimental or control), which has to be welcomed because it mimics reality. Outcomes should be objective and possibly routinely collected; standardised assessment, blinding and adjudication should be avoided as much as possible because this is not how assessment would be done outside a trial setting. The statistical analysis strategy must be guided by the objective to inform decision-making, thus favouring the intention-to-treat principle. Pragmatic trials should consider including process analyses to inform an understanding of the trial results. Needed data to conduct these analyses should be collected unobtrusively. Finally, ethical principles must be respected, even though this may seem to conflict with goals of pragmatism; consent procedures could be incorporated in the flow of care.

Indexed as

Pragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicResearch DesignHumansCluster randomised trialsHeterogeneityPragmatic randomised trials

Identifiers

PMID36303153
PMCPMC9615398

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.