Evidence map›Paper›PMID 40390137›Full record

ReviewPilot and feasibility studies2025

Design, analysis, and reporting of pilot and feasibility trials in anesthesiology: a methodological study.

Tariq Atkin-Jones, Mohamed Ali, Akudo C J Eze-Onuorah, Ezinne Ifeanacho, Azin Khosravirad, Kim Madden, Behnam Sadeghirad, Lawrence Mbuagbaw

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Pilot and feasibility studies, 2025. 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.

Tariq Atkin-JonesMichael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Mohamed AliMichael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Akudo C J Eze-OnuorahFaculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Ezinne IfeanachoFaculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Azin KhosraviradDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Kim MaddenDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Behnam SadeghiradDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Lawrence MbuagbawDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. mbuagblc@mcmaster.ca.ORCID http://orcid.org/0000-0001-5855-5461

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPilot and feasibility studies are effective tools for assessing the feasibility of performing larger-scale studies. These are particularly useful in anesthesiology, where the research overlaps with several other medical and surgical fields. The objective of this meta-epidemiological study is to assess the design and methodology of pilot and feasibility randomized controlled trials (RCTs) in anesthesiology.

methodsWe searched for pilot and feasibility RCTs in anesthesiology indexed in PubMed during a 5-year span between January 1, 2018, and December 31, 2022. We extracted bibliographic information, field of study, type of intervention, trial duration, trial design, use of qualitative data, use of progression criteria, whether the primary objective and primary outcome were related to feasibility, reported feasibility outcomes, and sample size justification. We conducted logistic regression to determine the factors associated with using progression criteria, having primary feasibility outcomes, and using feasibility outcomes to justify the sample size. We controlled for publication year, journal impact factor, source of funding, intervention type, and region.

resultsOur search retrieved 3015 trials, of which 248 were ultimately included and analyzed. Less than a third of studies stated feasibility as the primary objective (n = 77, 31.0%). Feasibility was a primary outcome in 46 (18.6%) studies, progression criteria were used in 27 (10.9%) studies, a sample size justification was listed in 134 (54.0%) studies, and 24 (9.7%) studies used qualitative data. We did not find any statistically significant association between progression criteria and any of the selected variables. Recently published trials had higher odds of having primary feasibility outcomes (odds ratio [OR] 1.39; 95% CI 1.06-1.83). Studies of pharmacological interventions had lower odds primary feasibility outcomes (OR 0.41; 95% CI 0.19-0.90). Recent studies also had higher odds of having a sample size justification based on a feasibility outcome rather than a clinical outcome or similar studies (OR 1.51; 95% CI 1.06-2.15).

conclusionsMore recently published pilot RCTs were significantly associated with having a primary feasibility outcome and determining sample size based on feasibility, while pharmacological studies were significantly associated with less reporting of primary feasibility outcomes. Future research addressing the factors limiting adherence to current guidelines is warranted.

Indexed as

AnesthesiologyFeasibilityFeasibility outcomePilotProgression criteriaQualitative dataRCT

Identifiers

PMID40390137
PMCPMC12087101

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.