RESUMO
BACKGROUND: There is limited measurement and reporting of quality of life (QoL) outcomes for patients with contact dermatitis (CD). OBJECTIVE: The purpose of this study is to develop a standardized Contact Dermatitis Quality of Life index (CDQL) for adult patients. METHODS: A list of 81 topics was compiled from a review of QoL measures used previously in CD research. A total of 2 rounds of web-based Delphi surveys were sent to physicians who registered to attend the 2018 American Contact Dermatitis Society meeting, asking that they rank the relevance of topics for measuring QoL in CD using a 4-point scale. Items met consensus for inclusion if at least 78% of respondents ranked them as relevant or very relevant, and their median score was ≥3.25. RESULTS: Of the 210 physicians contacted, 34 physicians completed the initial survey and 17 completed the follow-up survey. A total of 22 topics met consensus for inclusion in the CDQL, addressing symptoms, emotions, functions of daily living, social and physical functions, work/school functions, and treatment. CONCLUSIONS: This study was limited by the following factors: few open-ended questions in the initial survey, a lack of direct patient feedback, and long survey length, which likely contributed to lower survey participation. The CDQL is a comprehensive, CD-specific QoL measure developed on the basis of expert consensus via a modified Delphi process to be used by physicians and other health care professionals who care for adult patients with contact dermatitis.
RESUMO
PURPOSE: Clinical trials require significant resources, but benefits are only realized after trial completion and dissemination of results. We comprehensively assessed early discontinuation, registry results reporting, and publication by trial sponsor and subspecialty in urology trials. MATERIALS AND METHODS: We assessed trial registrations from 2007 to 2019 on ClinicalTrials.gov and publication data from PubMed®/MEDLINE®. Associations between sponsor or subspecialty with early discontinuation were assessed using Cox proportional hazards and results reporting or publication with logistic regression at 3 years after completion. RESULTS: Of 8,636 trials 3,541 (41.0%) were completed and 999 (11.6%) were discontinued. Of completed trials 26.9% reported results and 21.6% were published. Sponsors included academic institutions (53.1%), industry (37.1%) and the U.S. government (9.8%). Academic-sponsored (adjusted HR 0.81, 95% CI 0.69-0.96, p=0.012) and government-sponsored trials (adjusted HR 0.62, 95% CI 0.49-0.78, p <0.001) were less likely than industry to discontinue early. Government-sponsored trials were more likely to report (adjusted OR 1.72, 95% CI 1.17-2.54, p=0.006) and publish (adjusted OR 1.89, 95% CI 1.23-2.89, p=0.004). Academic-sponsored trials were less likely to report (adjusted OR 0.65, CI:0.48-0.88, p=0.006) but more likely to publish (adjusted OR 1.72, 95% CI 1.25-2.37, p <0.001). These outcomes were similar across subspecialties. However, endourology was more likely to discontinue early (adjusted HR 2.00, 95% CI 1.53-2.95, p <0.001), general urology was more likely to report results (adjusted OR 1.54, 95% CI 1.13-2.11, p=0.006) and andrology was less likely to publish (adjusted OR 0.53, 95% CI 0.35-0.81, p=0.003). CONCLUSIONS: Sponsor type is significantly associated with trial completion and dissemination. Government-sponsored trials had the best performance, while industry and academic-sponsored trials lagged in completion and results reporting, respectively. Subspecialty played a lesser role. Lack of dissemination remains a problem for urology trials.