TY - JOUR
T1 - Evaluating the underreporting of patient-reported outcomes in carpal tunnel syndrome randomized controlled trials
AU - Ladd, Chase
AU - Jacobsen, Samuel M.
AU - Snider, Kelsey
AU - Bacani, Rigel
AU - Hillman, Cody
AU - Shepard, Samuel
AU - Heigle, Benjamin
AU - Ottwell, Ryan
AU - Hartwell, Micah
AU - Vassar, Matt
N1 - Funding Information:
Competing interests: 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 for work unrelated to the current subject.
Funding Information:
Research funding: Development of this study was funded by the Oklahoma State University Center for Health Sciences Presidential Mentor-Mentee Research Fellowship Grant.
Publisher Copyright:
© 2023 the author(s), published by De Gruyter, Berlin/Boston.
PY - 2023/6/1
Y1 - 2023/6/1
N2 - 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).
AB - 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).
KW - CONSORT-PRO
KW - Carpal tunnel syndrome
KW - patient-reported outcomes
UR - http://www.scopus.com/inward/record.url?scp=85149246052&partnerID=8YFLogxK
U2 - 10.1515/jom-2022-0223
DO - 10.1515/jom-2022-0223
M3 - Article
C2 - 36840430
AN - SCOPUS:85149246052
SN - 2702-3648
VL - 123
SP - 301
EP - 308
JO - Journal of Osteopathic Medicine
JF - Journal of Osteopathic Medicine
IS - 6
ER -