TY - JOUR
T1 - Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization
AU - Brock, Lydia
AU - Hightower, Brooke
AU - Moore, Ty
AU - Nees, Danya
AU - Heigle, Benjamin
AU - Shepard, Samuel
AU - Kee, Micah
AU - Ottwell, Ryan
AU - Hartwell, Micah
AU - Vassar, Matt
N1 - Funding Information:
The authors report the following potential conflicts of interest or sources of funding M.H. reports receiving funding from the National Institute of Justice for work unrelated to the current subject. M.V. reports receipt of funding from the National Institute on Drug Abuse , the National Institute on Alcohol Abuse and Alcoholism , the U.S. 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. Full ICMJE author disclosure forms are available for this article online, as supplementary material .
Funding Information:
The authors report the following potential conflicts of interest or sources of funding M.H. reports receiving funding from the National Institute of Justice for work unrelated to the current subject. M.V. reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the U.S. 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. Full ICMJE author disclosure forms are available for this article online, as supplementary material.
Publisher Copyright:
© 2022 The Authors
PY - 2022/8
Y1 - 2022/8
N2 - Purpose: To evaluate the completeness of patient-reported outcomes (PROs) reporting using Consolidated Standards of Reporting Trials Patient-Reported Outcome (CONSORT-PRO) in randomized controlled trials (RCTs) involving rotator cuff injuries. Methods: We performed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on rotator cuff injuries that included at least one PRO measure. We included RCTs published from 2006 to 2020. Investigators extracted data from RCTs using the CONSORT-PRO and evaluated each RCT using the Cochrane Risk of Bias 2.0 tool. Our primary objective was to evaluate the mean completion percentage of CONSORT-PRO. Our secondary objective used bivariate regression analyses to explore the relationship between trial characteristics and completeness of reporting. Results: The initial search returned 467 results, with 33 published RCTs meeting the prespecified inclusion criteria. The mean CONSORT-PRO completeness across all included RCTs was 49.7% (standard deviation 15.43). An increase in sample size was associated with an increase in mean completeness of reporting (t = 2.31; P = .028). The Risk of Bias assessment found 29 (of 33, 87.88%) RCTs had “some concerns” for bias. We did not find any additional significant associations between completeness of reporting and trial characteristics. Conclusions: Randomized controlled trials involving rotator cuff injuries frequently use PRO measures as primary outcomes. Reporting of these PRO measures is suboptimal and may benefit from rigorous standardization. Clinical Relevance: PRO measures are increasingly incorporated as primary or secondary outcomes of RCTs. Appropriate reporting and use of state-of-the-art PRO measures may improve the dissemination of clinical knowledge from RCTs to guide treatment and determine intervention effectiveness. With increased adoption of Patient-Reported Outcome Measure Information System and adherence to CONSORT-PRO, orthopaedic literature may improve PRO reporting to optimize the interpretability of PROs and facilitate patient-centered care.
AB - Purpose: To evaluate the completeness of patient-reported outcomes (PROs) reporting using Consolidated Standards of Reporting Trials Patient-Reported Outcome (CONSORT-PRO) in randomized controlled trials (RCTs) involving rotator cuff injuries. Methods: We performed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on rotator cuff injuries that included at least one PRO measure. We included RCTs published from 2006 to 2020. Investigators extracted data from RCTs using the CONSORT-PRO and evaluated each RCT using the Cochrane Risk of Bias 2.0 tool. Our primary objective was to evaluate the mean completion percentage of CONSORT-PRO. Our secondary objective used bivariate regression analyses to explore the relationship between trial characteristics and completeness of reporting. Results: The initial search returned 467 results, with 33 published RCTs meeting the prespecified inclusion criteria. The mean CONSORT-PRO completeness across all included RCTs was 49.7% (standard deviation 15.43). An increase in sample size was associated with an increase in mean completeness of reporting (t = 2.31; P = .028). The Risk of Bias assessment found 29 (of 33, 87.88%) RCTs had “some concerns” for bias. We did not find any additional significant associations between completeness of reporting and trial characteristics. Conclusions: Randomized controlled trials involving rotator cuff injuries frequently use PRO measures as primary outcomes. Reporting of these PRO measures is suboptimal and may benefit from rigorous standardization. Clinical Relevance: PRO measures are increasingly incorporated as primary or secondary outcomes of RCTs. Appropriate reporting and use of state-of-the-art PRO measures may improve the dissemination of clinical knowledge from RCTs to guide treatment and determine intervention effectiveness. With increased adoption of Patient-Reported Outcome Measure Information System and adherence to CONSORT-PRO, orthopaedic literature may improve PRO reporting to optimize the interpretability of PROs and facilitate patient-centered care.
UR - http://www.scopus.com/inward/record.url?scp=85134758102&partnerID=8YFLogxK
U2 - 10.1016/j.asmr.2022.04.032
DO - 10.1016/j.asmr.2022.04.032
M3 - Article
AN - SCOPUS:85134758102
SN - 2666-061X
VL - 4
SP - e1429-e1436
JO - Arthroscopy, Sports Medicine, and Rehabilitation
JF - Arthroscopy, Sports Medicine, and Rehabilitation
IS - 4
ER -