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Evaluating reporting of patient-reported outcomes in randomized controlled trials regarding inflammatory bowel disease: a methodological study
  1. Ryan McIntire1,
  2. Philo Waters1,
  3. David Tanner1,
  4. Jaydeep Dhillon2,
  5. Cody Hillman1,
  6. Audrey Wise1,
  7. Micah Kee1,
  8. Reece Anderson1,
  9. Ryan Ottwell1,3,
  10. Micah Hartwell1,4,
  11. Matt Vassar1,4
  1. 1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
  2. 2Office of Research, Rocky Vista University College of Osteopathic Medicine, Parker, Colorado, USA
  3. 3Department of Internal Medicine, School of Community Medicine, Tulsa, Oklahoma, USA
  4. 4Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
  1. Correspondence to Ryan McIntire, Oklahoma State University Center for Health Sciences, Tulsa, OK 74107, USA; ryanmcvt9{at}gmail.com

Abstract

Patient-reported outcomes (PROs) in randomized controlled trials pertaining to inflammatory bowel disease are important in identifying patients’ perspective of treatment. Incompletely reported PROs within trials could misrepresent information for clinicians and may contribute to treatment which lacks accommodation of patient input. Our study evaluates completeness of reporting of PROs and risk of bias (RoB) to identify how well trialists are adhering to known resources for trials. We used MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify eligible trials from 2006 to 2020 with at least 1 PRO measure related to inflammatory bowel disease. The trials were screened in duplicate using Rayyan. We then compared trial completion of reporting to the Consolidated Standards of Reporting Trials (CONSORT)-PRO adaptation, and assessed RoB using the Cochrane Collaboration RoB 2.0 tool. To measure trial and reporting characteristics, we performed bivariate regression analyses. Among a sample of 29 trials, the mean completion percentage for CONSORT-PRO was 46.77%. We found PROs as a secondary outcome had significantly lower CONSORT-PRO reporting (p<0.05). In addition, per cent completeness of reporting was significantly higher with both a ‘therapy’ intervention, and trials published following the development of CONSORT-PRO (p<0.05). Incomplete PRO reporting is common in trials focused on inflammatory bowel disease. This suboptimal reporting indicates the need for adherence to reporting guidelines. Trialists should use the CONSORT-PRO checklist, as endorsed by Patient-Reported Outcomes Tools: Engaging Users and Stakeholders, to assess their studies in order to enhance reporting adherence.

  • Inflammatory Bowel Diseases

Data availability statement

Data are available in a public, open access repository. Reference number 23 is the dataset provided via Open Science Framework.

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Data availability statement

Data are available in a public, open access repository. Reference number 23 is the dataset provided via Open Science Framework.

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Footnotes

  • Contributors All authors have contributed to the concept, design, protocol, screening, data extraction, statistical analysis, and writing and editing of the manuscript to varying degrees. Each author's contributions to the stated areas have earned authorship unless otherwise stated in the ‘Acknowledgments’ section. The guarantor of this study is the corresponding author, RM.

  • Funding This work was supported by the Oklahoma State University Center for Health Sciences Presidential Mentor-Mentee Research Fellowship Grant.

  • Competing interests No financial or other sources of support were provided during the development of this manuscript. MH reports receiving funding from the National Institute of Justice for work unrelated to the current subject. MV reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences—all outside of the present work. All other authors have nothing to report.

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