Evidence map›Paper›PMID 41888611›Full record

ReviewActa anaesthesiologica Scandinavica2026

Key Features of Contemporary Pilot and Feasibility Trials: Protocol for a Methodological Study.

Aske Tøgern, Morten H Møller, Anders Perner, Maj-Brit N Kjær, Ruben J Eck, Carl T Anthon, Jehad A Barakji, Anders Granholm

Abstract readReview
In one paragraph

Review in Acta anaesthesiologica Scandinavica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Aske TøgernDepartment of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0009-0006-7858-4079
Morten H MøllerDepartment of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-6378-9673
Anders PernerDepartment of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-4668-0123
Maj-Brit N KjærDepartment of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-6536-0504
Ruben J EckDepartment of Internal Medicine, University Medical Center Groningen, Groningen, the Netherlands.ORCID 0000-0001-7440-2465
Carl T AnthonDepartment of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-7740-700X
Jehad A BarakjiDepartment of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0003-0855-6719
Anders GranholmDepartment of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-5799-7655

Funding

Dagmar Marshalls FondDanmarks Frie Forskningsfond 4308-00210BGrosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs FondNetherlands Thrombosis FoundationNovo Nordisk Fonden NNF23OC0085106Savværksejer Jeppe Juhl og hustru Ovita Juhls MindelegatSygeforsikringen 'danmark' 2020-0320
6 · The paper itself

Abstract

backgroundRandomised clinical trials (RCTs) are costly undertakings requiring careful design, planning and conduct. Failure to achieve timely participant recruitment, separation between intervention groups and adequate follow-up contributes to waste in research. Pilot RCTs offer researchers the opportunity to examine whether a definitive trial may work as intended, for example, assessing whether the targeted sample size can be recruited, whether protocol adherence and between-group separation are achievable and whether outcome data can be collected. To maximise their value, more attention to the design, conduct and reporting of pilot RCTs is likely required. Here, we aim to describe and characterise feasibility assessment methodology in a cohort of contemporary pilot RCTs in hospitalised patients.

methodsIn this methodological study, we will describe key features of contemporary pilot RCTs in hospitalised patients across medical and surgical specialties. We will search for pilot/feasibility RCTs published within the last half calendar year, with the aim of including at least 100 RCTs assessing feasibility. If necessary to achieve the minimum sample, the search will be expanded to a maximum of 5 years. We will extract data on key trial characteristics (including area of care and type of intervention and comparator), whether feasibility was assessed and feasibility assessment methodology (feasibility areas assessed, conduct as stand-alone pilot, use of pre-defined outcomes and pre-specified criteria for progression to definitive RCT, adequacy of sample size justification, plans for definitive RCT, assessment of clinical outcomes and whether a definitive trial was deemed feasible). Findings will be summarised using descriptive statistics for all trials and stratified by intervention type, area of care and comparator type.

conclusionsThe outlined methodological study will provide data on key features of contemporary pilot RCTs in hospitalised patients, including the feasibility assessment methodologies employed. This may improve design, conduct and reporting of future pilot RCTs, ultimately increasing their value and reducing research waste.

Indexed as

Randomized Controlled Trials as TopicResearch DesignFeasibility StudiesHumansPilot ProjectsSample Sizefeasibilitypilot trialrandomised clinical trial

Identifiers

PMID41888611
PMCPMC13021571

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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.