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Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials

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Abstract

Esophageal motility disorders (EMD) can have significant effects on quality of life. Patient-reported outcomes (PROs) provide valuable insight into the patient’s perspective on their treatment and are becoming increasingly used in randomized controlled trials (RCTs). Thus, our investigation aims to evaluate the completeness of reporting of PROs in RCTs pertaining to EMDs. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on EMDs. Included RCTs were published between 2006 and 2020, reported a primary outcome related to an EMDs, and listed at least one PRO measure as a primary or secondary outcome. Investigators screened and extracted data in a masked, duplicate fashion. Data extraction was carried out using both the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias 2.0 tool. We assessed overall mean percent completion of the CONSORT-PRO adaptation and a bivariate regression analysis was used to assess relationships between trial characteristics and completeness of reporting. The overall mean percent completion of the CONSORT-PRO checklist adaptation was 43.86% (SD = 17.03). RCTs with a primary PRO had a mean completeness of 47.73% (SD = 17.32) and RCTs with a secondary PRO was 35.36% (SD = 13.52). RCTs with a conflict of interest statement were 18.15% (SE = 6.5) more complete (t = 2.79, P = .009) than trials lacking a statement. No additional significant associations between trial characteristics and completeness of reporting were found. PRO reporting completeness in RCTs focused on EMDs was inadequate. We urge EMD researchers to prioritize complete PRO reporting to foster patient-centered research for future RCTs on EMDs.

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Acknowledgements

In memoriam of Abbey Renner, we are grateful for her expertise during the drafting of this manuscript. We are grateful to April Schweikhard who assisted in the development of our search strategy and to the OSU medical library for procurement of relevant literature.

Funding

Development of this study was funded by the Oklahoma State University Center for Health Sciences Presidential Mentor–Mentee Research Fellowship Grant.

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Authors and Affiliations

  1. Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17th St., Tulsa, OK, 74107, USA

    Jordan Staggs, Cole Williams, Mitchell Love, Abbey Renner, Micah Kee, Cody Hillman, Samuel Shepard, Benjamin Heigle, Shelby Rauh, Ryan Ottwell, Micah Hartwell & Matt Vassar

  2. Department of Internal Medicine, School of Community Medicine, University of Oklahoma, Tulsa, OK, USA

    Ryan Ottwell

  3. Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

    Micah Hartwell & Matt Vassar

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  1. Jordan Staggs
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Correspondence to Jordan Staggs.

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Conflict of interest

No financial or other sources of support were provided during the development of this manuscript. Dr. Hartwell reports receiving funding from the National Institute of Justice for work unrelated to the current subject. Dr. Vassar 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.

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Staggs, J., Williams, C., Love, M. et al. Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials. Dysphagia 37, 1576–1585 (2022). https://doi.org/10.1007/s00455-022-10415-7

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