Evidence map›Paper›PMID 42331572›Full record

ReviewBMJ open2026

Do we consider scalability from the outset? A methodological review of pilot randomised controlled health trials.

Matthew Mclaughlin, Kaylie Toll, Bronwyn Myers, Hugh Riddell, Joanna Moullin, Christopher M Reid, Eleanor Quested, Matthew D McDonald

Abstract readReview
In one paragraph

Review in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

8 authors.

Matthew MclaughlinCurtin School of Population Health, Curtin University, Perth, Western Australia, Australia.ORCID http://orcid.org/0000-0003-2870-8556
Kaylie TollCurtin School of Population Health, Curtin University, Perth, Western Australia, Australia.ORCID http://orcid.org/0000-0002-4553-2188
Bronwyn MyersCurtin enAble Institute, Curtin University, Perth, Western Australia, Australia.ORCID http://orcid.org/0000-0003-0235-6716
Hugh RiddellCurtin School of Population Health, Curtin University, Perth, Western Australia, Australia.
Joanna MoullinCurtin School of Population Health, Curtin University, Perth, Western Australia, Australia.
Christopher M ReidCurtin School of Population Health, Curtin University, Perth, Western Australia, Australia.ORCID http://orcid.org/0000-0001-9173-3944
Eleanor QuestedCurtin School of Population Health, Curtin University, Perth, Western Australia, Australia.ORCID http://orcid.org/0000-0002-6211-9045
Matthew D McDonaldCurtin School of Population Health, Curtin University, Perth, Western Australia, Australia matthew.mcdonald1@curtin.edu.au.ORCID http://orcid.org/0000-0002-8191-8854

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesHealth interventions should be designed to be appropriate for scaling from the outset, but the extent to which factors that are important for scalability are reported on in pilot randomised trials is unclear. This review assesses the extent to which pilot randomised trials report on 15 domains of intervention scalability.

designMethodological review. DATA SOURCES: Four journals were searched: ELIGIBILITY CRITERIA: We included pilot randomised trials of health interventions. DATA EXTRACTION AND SYNTHESIS: Data relevant to 15 scalability domains, derived from the Intervention Scalability Assessment Tool and wider implementation science literature, were extracted. Data were double-extracted for 20% of the included studies. Two authors scored all studies from 0 to 3 (0=Not at all; 1=Small extent; 2=Moderate extent; 3=Large extent) on the extent to which each of the 15 scalability domains was reported. For each scalability domain, we calculated the mean score and the frequency of each categorical score across the included studies.

resultsTitles and abstracts screening (521 publications) resulted in 132 full-text publications for review. Of the 104 eligible studies, a random sample of 50 studies were selected for detailed review. Through snowballing, an additional 49 associated publications were identified (eg, protocols), resulting in 99 publications across 50 studies. Most studies reported the

conclusionsThe extent of scalability domain reporting in pilot trials of health interventions is limited. Explicit consideration of scalability in pilot trials could improve the design of fully powered randomised controlled trials and enhance the potential for effective interventions to be translated into practice. Future research should consider if and how to incorporate scalability considerations into pilot trials, and whether pilot trial and intervention reporting guidelines should be expanded to include scalability considerations.

Indexed as

Randomized Controlled Trials as TopicResearch DesignHumansPilot ProjectsFeasibility StudiesImplementation ScienceRandomized Controlled Trial

Identifiers

PMID42331572
PMCPMC13288692

What OpenQuestion holds

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LicenceCC BY-NC
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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.