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

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Emergency medicine
Original research
Methodological standards in the design and reporting of pilot and feasibility studies in emergency medicine literature: a systematic review
  1. Onlak Ruangsomboon1,
  2. João Pedro Lima2,
  3. Mohamed Eltorki3,4,
  4. Andrew Worster2,5
  1. 1Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
  2. 2Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
  3. 3Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
  4. 4Department of Pediatrics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
  5. 5Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
  1. Correspondence to Onlak Ruangsomboon; doctor.mo{at}yahoo.com

Abstract

Objective Pilot 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.

Design Methodological 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.

Results A 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.

Conclusion Main 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.

  • STATISTICS & RESEARCH METHODS
  • ACCIDENT & EMERGENCY MEDICINE
  • Randomized Controlled Trial

Data availability statement

No data are available. Not applicable.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2023-082648

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    Data availability statement

    No data are available. Not applicable.

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    Footnotes

    • Contributors OR, ME and AW conceived and designed the study. OR, JPL, ME and AW collected, managed and analysed the data. OR drafted the article. AW supervised the conduct of the study and provided critical insights for the review. OR takes responsibility for the paper as a whole and is the guarantor of the study.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.