Underreporting of patient-reported outcomes in cystic fibrosis randomized controlled trials using CONSORT-PRO and RoB 2.0.

BACKGROUND: Patient-reported outcomes (PROs) are increasingly used in randomized controlled trials (RCTs) to foster patient-centered healthcare. The aim of this investigation was to assess the completeness of reporting of PROs in RCTs pertaining to cystic fibrosis (CF). METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for RCTs concerning CF that included PROs as a primary or secondary outcome. The RCTs were assessed by 2 independent investigators using an adaptation of the Consolidated Standards of Reporting Trials for Patient-Reported Outcomes (CONSORT-PRO) and the Cochrane Risk of Bias (RoB) 2.0 assessment. We calculated the mean completion percentage of adherence to the CONSORT-PRO adaptation and used bivariate regression models to evaluate for associations with particular trial characteristics. RESULTS: Our systematic search returned 2302 potential studies. Fifty-nine eligible RCTs were included after full-text screening. The RCT mean completeness of reporting was 38.38% (SD = 12.74). We found the following associations between trial characteristics and completeness of PRO reporting: (1) significantly higher reporting completeness for RCTs published in journals requiring adherence to the CONSORT guideline (p-value = 0.049), (2) improved reporting completeness in studies with 'some concerns' of RoB versus 'high' RoB (p-value = 0.042), and (3) significantly better reporting completeness when the PRO is the primary outcome of a RCT (p-value = 0.006). CONCLUSION: Inadequate PRO reporting exists within RCTs focused on CF. Given that CF has substantial effects on quality of life, PROs are imperative to understand patients' experiences. We believe greater adherence to CONSORT-PRO will promote the standardization of PRO reporting and will facilitate comprehension of PROs by stakeholders, patients, and clinicians.

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

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.