Musculoskeletal Medicine and PainORIGINAL ARTICLE

Evaluating the underreporting of patient-reported outcomes in carpal tunnel syndrome randomized controlled trials

Chase Ladd, BS; Samuel M. Jacobsen, BS; Kelsey Snider, MM; Rigel Bacani, BA, BS; Cody Hillman, BS; Samuel Shepard, BS; Benjamin Heigle, BS; Ryan Ottwell, DO; Micah Hartwell, PhD; and Matt Vassar, PhD
Notes and Affiliations
Notes and Affiliations

Received: November 6, 2022

Accepted: December 24, 2022

Published: February 27, 2023

  • Chase Ladd, BS, 

    Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

  • Samuel M. Jacobsen, BS, 

    Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

  • Kelsey Snider, MM, 

    Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

  • Rigel Bacani, BA, BS, 

    Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

  • Cody Hillman, BS, 

    Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

  • Samuel Shepard, BS, 

    Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

  • Benjamin Heigle, BS, 

    Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

  • Ryan Ottwell, DO, 

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

  • Micah Hartwell, PhD, 

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

  • Matt Vassar, PhD, 

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

J Osteopath Med; 123(6): 301-308
Abstract

Context: In recent years, patient-centered healthcare has become a primary concern for researchers and healthcare professionals. When included in randomized controlled trials (RCTs), patient-reported outcome (PRO) measures serve a critical role in supplementing efficacy outcomes with a patient perspective.

Objectives: The goals of this study are to evaluate the reporting completeness of PROs within literature concerning carpal tunnel syndrome (CTS) utilizing the Consolidated Standards of Reporting Trials Patient-Reported Outcomes (CONSORT-PRO) extension.

Methods: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for published RCTs relating to CTS with at least one PRO measure from 2006 to 2020. Two investigators screened all RCTs for inclusion utilizing Rayyan (https://rayyan.qcri.org/), a systematic review screening platform. In an independent, masked fashion, investigators then evaluated all RCTs utilizing the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Bivariate regression analyses were utilized to assess relationships between trial characteristics and completeness of reporting.

Results: Our search returned 374 publications, yet only 31 unique RCTs met the inclusion criteria. The mean overall percent of adherence for CONSORT-PRO was 41%. Our secondary outcome—assessing study characteristics—indicated significantly higher completeness of reporting in the absence of a conflict of interest statement (p<0.05), ‘some concerns’ for bias (p<0.005), and when journals required the use of the CONSORT statement (p<0.005). The RoB assessment determined overall suspicion for bias among included RCTs, with 35% (n=11/31) being labeled as ‘high,’ 58% (n=18/31) as ‘some concerns,’ and 7% (n=2/31) as ‘low.’

Conclusions: Our study indicated that the completeness of CONSORT-PRO reporting was deficient within CTS trials. Because of the importance placed on PROs in clinical practice, we recommend adherence to CONSORT-PRO prior to publication of RCTs to increase the understanding of various interventions on patients’ quality of life (QoL).

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