Dataset Information

Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization.

ABSTRACT:

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.

SUBMITTER: Brock L

PROVIDER: S-EPMC9402470 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization.

Brock Lydia L Hightower Brooke B Moore Ty T Nees Danya D Heigle Benjamin B Shepard Samuel S Kee Micah M Ottwell Ryan R Hartwell Micah M Vassar Matt M

Arthroscopy, sports medicine, and rehabilitation 20220715 4

<h4>Purpose</h4>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.<h4>Methods</h4>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 200 ...[more]

PMID: 36033194

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Project description:PurposeTo compare patient-reported and surgical outcome measures in patients with and without secondary shoulder stiffness (SSS) undergoing rotator cuff repair (RCR).MethodsPatients undergoing rotator cuff repair from 2014 to 2020 with complete patient-reported outcome measures (PROMs) by the short-form 12 survey (SF-12) were retrospectively reviewed to identify if operative intervention for SSS was performed alongside the RCR. Those patients with operative intervention for SSS were propensity matched to a group without prior intervention for stiffness by age, sex, laterality, body mass index, diabetes mellitus status, and the presence of a thyroid disorder. The groups were compared by rotator cuff tear (RCT) size, surgical outcomes, further surgical intervention, rotator cuff retear rate, postoperative range of motion (ROM), and SF-12 results at 1 year after surgery. Delta values were calculated for component scores of the SF-12 and ROM values by subtracting the preoperative result from the postoperative result.ResultsA total of 89 patients with SSS were compared to 156 patients in the control group at final analysis. The patients in the SSS group experienced a significant improvement in the delta mental health component score (MCS-12) of the SF-12 survey that was not seen in the control group (P = .005 to P = .539). Both groups experienced significant improvement by the delta physical health component score (PCS-12) of the SF-12 survey (SSS: 7.68; P < .001; control: 6.95; P < .001). The SSS group also experienced greater improvement of their forward flexion (25.8° vs 12.9°; P = .005) and external rotation (7.13° vs 1.65°; P = .031) ROM than the control group.ConclusionsOperative intervention of SSS at the time of RCR has equivalent postoperative SF-12 survey outcome scores when compared to patients undergoing RCR without preoperative stiffness despite those patients having lower preoperative scores.Level of evidenceLevel III retrospective comparative study.

Project description:BackgroundLarge-scale data assessing the effect of a prior failed rotator cuff repair (RCR) on the outcome of reverse shoulder arthroplasty (RSA) is currently lacking. Therefore, this study aimed (1) to assess the course of patients undergoing RCR, specifically focusing on the need for conversion to RSA within two years, and (2) to compare outcomes following RSA performed for rotator cuff tears (RCTs) with and without prior RCR.MethodsThis retrospective cohort study included data from the CMS Data Set (2016-2018). For the first study objective, we included patients undergoing an RCR; these were followed for 24 months to identify a conversion to RSA. For the second study objective, we included RSAs for RCTs, stratified by those with and without a prior RCR (preceding 24 months). Outcomes (hospitalization cost, institutional post-acute care discharge, 90-day readmission and health resource utilization up to 6 months post-RSA) were compared between propensity score-matched groups.ResultsOut of 33,244 RCRs, 433 (1.3%) patients underwent RSA conversion within two years. Among 7534 RSA cases for RCTs, 245 (3.3%) had an RCR in the preceding two years. In the propensity score analysis, except for a minimal increase in the number of physical rehabilitation visits (RR 1.10; p = 0.0009), no differences were observed between those with and without prior RCR in terms of other RSA outcomes. These included hospitalization cost, discharge to institutional post-acute care facility, 90-day readmission and 6-month post-op cost.ConclusionRotator cuff repair in elderly patients, when utilizing currently employed indication criteria, results in low conversion rates to RSA within 2 years postoperatively. Furthermore, large dataset outcomes after RSA for RCT such as cost, post-acute care discharge, physical rehabilitation, and readmission rates appear not to be negatively affected by the presence of a prior RCR.Level of evidenceLevel 3 evidence; Retrospective cohort study.

Dataset Information

Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization.

Purpose

Methods

Results

Conclusions

Clinical relevance

Publications

Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization.

Similar Datasets

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