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.

Quality of reporting among systematic reviews underpinning the ESC/ACC guidelines on ventricular arrhythmias and sudden cardiac death.

OBJECTIVES: The main objective of this study was to assess the methodological and reporting quality of the systematic reviews (SRs) supporting the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) clinical practice guidelines (CPGs) recommendations for the management of patients with ventricular arrhythmias and sudden cardiac death (SCD). As a secondary objective, we sought to determine: (1) the proportion of Cochrane SRs were cited; and (2) whether Cochrane SRs scored higher on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2) appraisals. DESIGN: Cross-sectional analysis. MAIN OUTCOME MEASURES: We searched for CPGs published by the ESC and the ACC from 2010 to 2020. We selected the CPGs for ventricular arrhythmias and the prevention of SCD. The reference sections were searched for SRs. Two independent investigators evaluated eligible SR using the PRISMA checklist and the AMSTAR-2 assessment tool. RESULTS: Two CPGs for ventricular arrhythmia and SCD were included in this study. Fifty-five SRs were included in our analysis. Across all SRs, the mean PRISMA score was 0.70. The lowest scoring PRISMA item related to the presence of a pre-published protocol (item 5, score 0.17). Overall, 40% of included SRs were found to have 'critically low' AMSTAR-2 ratings. One of the lowest scoring items for AMSTAR-2 was reporting of sources of funding (item 10). The 4 Cochrane SRs that were included scored higher on both assessment tools than non-Cochrane studies, specifically in PRISMA overall completion (88.7% vs 69.7%). CONCLUSION: Our study suggests the methodological and reporting quality of SRs used within ESC and ACC CPGs is insufficient, as demonstrated by the lack of adherence to both AMSTAR-2 and PRISMA checklists. Given the importance of CPGs on clinical decision making, and ultimately patient care, the methodological rigour and quality reporting within SRs used in CPGs should be held to the highest standard within the field of cardiology.

An Evaluation of Primary Studies Published in Predatory Journals Included in Systematic Reviews From High-Impact Dermatology Journals: Cross-sectional Study.

BACKGROUND: Predatory publishing is a deceptive form of publishing that uses unethical business practices, minimal to no peer review processes, or limited editorial oversight to publish articles. It may be problematic to our highest standard of scientific evidence-systematic reviews-through the inclusion of poor-quality and unusable data, which could mislead results, challenge outcomes, and undermine confidence. Thus, there is a growing concern surrounding the effects predatory publishing may have on scientific research and clinical decision-making. OBJECTIVE: The objective of this study was to evaluate whether systematic reviews published in top dermatology journals contain primary studies published in suspected predatory journals (SPJs). METHODS: We searched PubMed for systematic reviews published in the top five dermatology journals (determined by 5-year h-indices) between January 1, 2019, and May 24, 2021. Primary studies were extracted from each systematic review, and the publishing journal of these primary studies was cross-referenced using Beall's List and the Directory of Open Access Journals. Screening and data extraction were performed in a masked, duplicate fashion. We performed chi-square tests to determine possible associations between a systematic review's inclusion of a primary study published in a SPJ and particular study characteristics. RESULTS: Our randomized sample included 100 systematic reviews, of which 31 (31%) were found to contain a primary study published in a SPJ. Of the top five dermatology journals, the Journal of the American Academy of Dermatology had the most systematic reviews containing a primary study published in an SPJ. Systematic reviews containing a meta-analysis or registered protocol were significantly less likely to contain a primary study published in a SPJ. No statistically significant associations were found between other study characteristics. CONCLUSIONS: Studies published in SPJs are commonly included as primary studies in systematic reviews published in high-impact dermatology journals. Future research is needed to investigate the effects of including suspected predatory publications in scientific research.