Evidence map›Paper›PMID 39532355›Full record

SynthesisBMJ open2024

Methodological standards in the design and reporting of pilot and feasibility studies in emergency medicine literature: a systematic review.

Onlak Ruangsomboon, João Pedro Lima, Mohamed Eltorki, Andrew Worster

Abstract readSystematic Review
In one paragraph

Synthesis in BMJ open, 2024. 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

4 authors.

Onlak RuangsomboonDepartment of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand doctor.mo@yahoo.com.ORCID 0000-0002-0848-7162
João Pedro LimaDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Mohamed EltorkiDepartment of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.ORCID 0000-0001-6978-0015
Andrew WorsterDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePilot and feasibility studies are intended to ensure that subsequent randomised controlled trials (RCTs) are feasible, economical and rigorous, especially in a challenging research environment such as emergency medicine (EM). We aimed to evaluate the methodological quality in conducting and reporting randomised pilot and feasibility studies in the EM literature and propose recommendations to improve their quality.

designMethodological systematic review. DATA SOURCES AND ELIGIBILITY: We searched MEDLINE and Embase (2018-29 September 2023) for pilot or feasibility RCTs published as full texts in the five top-ranked and other first-quartile EM journals according to Scimago. DATA EXTRACTION AND ANALYSIS: We assessed their methodological features and reporting quality primarily based on the Consolidated Standards of Reporting Trials (CONSORT) extension.

resultsA total of 24 randomised trials identified as pilot (n=13), feasibility (n=3) or both (n=8) were included. At least one feasibility outcome was assessed in 9 trials (feasibility trials), while 15 others only focused on treatment efficacy (efficacy trials). Only three (12.5%) studies progressed to the main trials. Among 12 feasibility trials, 55.6% reported their outcomes with uncertainty estimates, and 33.3% had clear progression criteria. Efficacy trials tended to draw clinical implications on their results. Studies from the five top-ranked journals had better methodological and reporting quality than those from other first-quartile journals.

conclusionMain methodological concerns for pilot and feasibility studies in first-quartile EM literature include misconceptions, misuses and suboptimal design and reporting quality. These issues were more prominent in lower-ranked first-quartile journals. Our findings highlight the need for resources and training for researchers, journal editors and peer reviewers on the value, objectives and appropriate conduct of pilot and feasibility studies. The conceptual framework and standardised methodological components should be emphasised. EM journals should reinforce the reporting standards and support their publication. These actions can lead to more methodologically rigorous pilot and feasibility studies in EM. PROSPERO REGISTRATION NUMBER: CRD42023468437.

Indexed as

Emergency MedicineFeasibility StudiesRandomized Controlled Trials as TopicResearch DesignHumansPilot ProjectsACCIDENT & EMERGENCY MEDICINERandomized Controlled TrialSTATISTICS & RESEARCH METHODS

Identifiers

PMID39532355
PMCPMC11555100

What OpenQuestion holds

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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.