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

التفاصيل البيبلوغرافية
العنوان: Underreporting of patient-reported outcomes in cystic fibrosis randomized controlled trials using CONSORT-PRO and RoB 2.0
المؤلفون: Ty Moore, Danya Nees, Brooke Hightower, Lydia Brock, Micah Kee, Audrey Wise, Benjamin Heigle, Ryan Ottwell, Micah Hartwell, Matt Vassar
المصدر: Respiratory Medicine and Research. 83:100962
بيانات النشر: Elsevier BV, 2023.
سنة النشر: 2023
مصطلحات موضوعية: Pulmonary and Respiratory Medicine
الوصف: 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).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.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).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.
تدمد: 2590-0412
DOI: 10.1016/j.resmer.2022.100962
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dfcf6b035a165e1a28f08eb08689eea5
https://doi.org/10.1016/j.resmer.2022.100962
Rights: OPEN
رقم الانضمام: edsair.doi.dedup.....dfcf6b035a165e1a28f08eb08689eea5
قاعدة البيانات: OpenAIRE
الوصف
تدمد:25900412
DOI:10.1016/j.resmer.2022.100962