Assessing the degree to which randomized controlled trials align with the core outcome set for osteoarthritis of knee and hip: A cross-sectional analysis.

OBJECTIVE: To assess the degree of core outcome set alignment and identify issues with alignment to the 2019 COS among clinical trial registrations focused on knee and/or hip osteoarthritis (OA). METHODS: Our search was performed on registered knee and hip OA randomized controlled trials (RCTs) available on ClinicalTrials.gov and WHO International Clinical Trials Registry Platform. The screening process considered trials registered between 8/2014 and 6/2023. We extracted data on general trial characteristics and the five trial endpoints detailed in the COS (pain, physical function, quality of life, patient global assessment, and adverse events), in a masked and duplicate manner. The frequencies of COS alignment were assessed over time prior to and after COS publication. RESULTS: Of the 10,718 RCTs screened, 481 met inclusion criteria. Most were phase 3 (368/481, 76.51%) and heavily university-funded (184/481, 38.25%). Despite the 2019 COS, no marked enhancement in overall alignment was noted. The outcome 'Pain' exhibited the highest degree of COS alignment (455/481, 94.59%), whereas 'adverse events' lagged behind (89/481, 18.50%). Additionally, trial factors such as 'Continent', 'Funding Type', and 'Recruitment Status' displayed no significant influence on COS alignment. CONCLUSIONS: Despite the acknowledged advantages of using COS in RCTs and the availability of an updated COS, the alignment to these outcomes remains notably low. Significant efforts are needed to encourage broader adoption in future studies on knee and hip OA, with the aim of improving research quality and patient care.

Assessing uptake of the core outcome set in clinical trials for immune thrombocytopenia: A cross-sectional analysis.

INTRODUCTION: Clinical trials (CTs) guide clinical practice, but inconsistent outcome reporting presents challenges. To increase comparability, a core outcome set (COS) was created for primary Immune thrombocytopenia (ITP) in 2009 to standardize outcome measurements. We aimed to evaluate uptake of the primary ITP COS in CT registries. MATERIALS & METHODS: Our cross-sectional analysis employed a search string on ClinicalTrials.gov and ICTRP for phase III/IV CTs in June 2023. Inclusion criteria consisted of subjects with primary ITP, study was registered five years before COS publication to June 26, 2023, and assessed effectiveness of interventions. Two investigators extracted data in a masked, duplicate manner. Interrupted time series analysis, ANOVAs, and correlation analyses were conducted to assess the main outcome of COS uptake pre/post COS publication. RESULTS: The search identified 131 eligible trials for data extraction. Altogether, 38.2 % (50/131) followed IWG platelet response guidelines. An alternative platelet count measurement was 50,000 × 109 L, with 46.56 % (61/131) of trials reporting it. The most measured outcome was adverse events (106/131, 80.9 %). Remaining secondary outcomes were measured in <50 % of studies. After COS publication, there was a statistically non-significant 0.03 % (p = 0.50, CI 95 % = [-0.06, 0.13]) 0.03 % (p = 0.50, CI 95 % = [-0.06, 0.13]) increase in the monthly trend of COS-defined outcomes. CONCLUSION: We found a non-significant increase in uptake of the ITP COS since its publication and highlighted the lack of standardization among endpoints within ITP clinical trials. Our analysis highlights the need for heightened awareness and a COS update that acknowledges the variability in clinical trials.

Assessing the uptake of the type 1 diabetes core outcome set in randomized controlled trials: A Cross-Sectional study.

AIMS: This study analyzed uptake of the core outcome set (COS) for type 1 diabetes (T1D) and trends in its use before and after its development in December 2017. METHODS: On June 26, 2023, ClinicalTrials.gov was systematically searched for T1D randomized controlled trials. The Core Outcome Measures in Effectiveness Trials (COMET) database provided a COS of eight key outcomes for analysis. Included trials were analyzed for COS uptake before and after its release in December 2017 in a masked, duplicate fashion by independent reviewers. We also calculated the proportion of trials that measured the complete COS and assessed the most frequently reported COS outcomes. RESULTS: Of 3,792 originally screened articles, 144 RCTs were included in the final sample. Following COS publication, its use steadily decreased. Within the COS, HbA1c and severe hypoglycemia were most frequently implemented as endpoints; other recommended outcomes were rarely used in the published trials. CONCLUSION: Despite the 2017 T1D COS publication, use has decreased over time. This inconsistency negatively influences evidence-based practices and care. Educating researchers on COS and promoting uptake is crucial. Wider COS adoption in T1D trials could enhance clinical research overall. Further study of barriers and facilitators influencing uptake is essential to support consistent use and reporting.

Reporting of Harms in Randomized Controlled Trials Published in Urology Journals: An Updated Analysis.

PURPOSE: Harms are often overlooked, but important, outcomes of randomized controlled trial reporting. Our goal was to determine if harms reporting has improved in high-impact urology journals. MATERIALS AND METHODS: Randomized controlled trials published in The Journal of Urology®, Urology, European Urology, and BJU International in 2012 and 2020 were analyzed. Each randomized controlled trial was evaluated by 2 authors in a masked-duplicate fashion to evaluate for adherence to harms reporting guidelines recommended by the Consolidated Standards of Reporting Trials (CONSORT) group. RESULTS: One hundred and thirty-two published studies met inclusion criteria. Between 2012 and 2020, there was a statistically significant increase in the median number of harms criteria reported between 2012 and 2020 (5.3 vs 7.2; P = .01). Methods criteria demonstrating the greatest improvements included item #3 "which harms were assessed," item #4a "when harm information was collected," and item #4b "methods to attribute harm to intervention." Results sections with the most improvement in reporting include item #6 "reasons for patient withdrawal," item #8a "effect size for harms," and item #8b "stratified serious + minor harms." CONCLUSIONS: Reporting of adverse events in randomized trials published in several top urology journals has demonstrated marked improvement. Studies published in 2020 reported approximately 70% of CONSORT-Harms criteria-an increase of nearly 40% since 2004. While these improvements mark significant change, deficits remain present and should be addressed to provide clinicians with the most complete perspective possible.