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  • Quality and completeness of, and spin in reporting of, pilot and feasibility studies in hip and knee arthroplasty: a protocol for a methodological survey

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Research methods
Protocol
Quality and completeness of, and spin in reporting of, pilot and feasibility studies in hip and knee arthroplasty: a protocol for a methodological survey
  1. Zinnia Chung1,
  2. Lawrence Mbuagbaw2,3,
  3. Lipalo Mokete4,
  4. Mohit Bhandari5,
  5. Lehana Thabane6,7
  1. 1Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada
  2. 2Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
  3. 3Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
  4. 4Division of Orthopaedic Surgery, University of the Witwatersrand Johannesburg, Johannesburg, Gauteng, South Africa
  5. 5Department of Surgery, McMaster University, Hamilton, Ontario, Canada
  6. 6Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
  7. 7Research Institute, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
  1. Correspondence to Dr Lehana Thabane; thabanl{at}mcmaster.ca

Abstract

Introduction Pilot or feasibility trials examine the feasibility, viability and recruitment potential of larger, main trials. Specifically, a pilot trial can be instrumental in identifying methodological issues essential to the development of an effective research protocol. However, numerous studies published as pilot or feasibility studies have demonstrated notable inconsistencies in the nature of information reported, resulting in poor-quality and incomplete reporting. It is unclear whether such low quality or incompleteness of reporting is also prevalent in arthroplasty pilot trials.

Methods and analysis This protocol outlines a methodological survey examining the completeness of reporting among hip and knee arthroplasty pilot trials in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 extension to pilot trials. Secondary objectives include: (1) determining the prevalence of ‘spin’ practices, defined as: (a) placing a focus on statistical significance rather than feasibility, (b) presenting results that show the trial to be non-feasible as feasible or (c) emphasising the effectiveness or potential intervention benefits rather than feasibility; (2) determining factors associated with incomplete reporting, and ‘spin’. A search of PubMed will be conducted for pilot trials in hip or knee arthroplasty published between 01 January 2017 and 31 December 2023. Following screening, appropriate data will be extracted from eligible publications and reported as descriptive statistics, encompassing elements of the CONSORT checklist associated with completeness of reporting. Logistic regression analysis and Poisson regression will be used to analyse factors associated with completeness of reporting and spin.

Ethics and dissemination This methodological review does not require formal ethical approval, as it will solely involve the use of published and publicly reported literature. The results of this study will be disseminated through submission to peer-reviewed journals and academic conference presentations. Study details will be sent to McMaster University’s media coordinators to be shared through the institution’s research-focused platforms.

  • feasibility studies
  • statistics & research methods
  • hip
  • knee
  • orthopaedic & trauma surgery
  • orthopaedic & trauma surgery
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-2024-085441

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    Footnotes

    • Contributors LT and ZC conceived the study and drafted the manuscript. This included the development of all sections, from the writing of the introduction, formulation of methods and creation of relevant supplemental material (tables and calculations). All authors (LMb, LMo, MB, ZC and LT) reviewed different versions of the manuscript, proposed critical revisions and approved the final version. LT 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.