Implementation of patient-reported outcome measures in real-world evidence studies: Analysis of ClinicalTrials.gov records (1999-2021)
Implementation of patient-reported outcome measures in real-world evidence studies: Analysis of ClinicalTrials.gov records (1999-2021)
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DOI：
10.1016/j.cct.2022.106882
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发表时间：
2022-08-23
影响因子：
2.2
通讯作者：
Calvert, Melanie J.
中科院分区：
文献类型：
--
作者：
Maruszczyk, Konrad;Aiyegbusi, Olalekan Lee;Calvert, Melanie J.
背景：真实世界证据（RWE）在全球监管和报销过程中发挥着越来越重要的作用。RWE的产生可以通过收集和使用患者报告的结果（pro）来增强，pro可以从患者的角度提供有关健康干预措施的有效性、安全性和耐受性的宝贵信息。本分析旨在检查和总结在现实世界的研究中患者报告的结果测量（PROMs）的使用情况。方法：自Clinicaltrials.gov数据库建立以来，于2021年7月22日下载了IV期试验的描述。建立了一个自动算法来检测利用PROMs和包括患者报告成分的复合措施的试验。搜索词是基于PROQOLID数据库开发的。结果：在1999年至2021年7月Clinicaltrials.gov上发布的27,976项IV期临床试验中，分别有21%和4%使用了PROMs和复合措施。近年来，在IV期试验中，prom的使用稳步增加。结论：PROMs在IV期试验中的使用似乎低于其在早期临床研究阶段的使用。可以通过多种方式促进在莱茵河畔研究中更多地采用PROMs，包括制定其收集、分析和使用的标准。
Background: Real-world evidence (RWE) plays an increasingly important role within global regulatory and reimbursement processes. RWE generation can be enhanced by collecting and using patient-reported outcomes (PROs), which can provide valuable information on the effectiveness, safety, and tolerability of health in-terventions from the patient perspective. This analysis aims to examine and summarise the utilisation of patient -reported outcomes measures (PROMs) in real-world studies. Methods: Descriptions of phase IV trials were downloaded on July 22, 2021 from the Clinicaltrials.gov database since its inception. An automated algorithm was built to detect trials utilising PROMs and composite measures including patient-reported components. Search terms were developed based on the PROQOLID database. Results: Of 27,976 phase IV clinical trials posted on Clinicaltrials.gov between 1999 and July 2021, 21% and 4% used PROMs and composite measures, respectively. Recent years demonstrated a steady increase in the uti-lisation of PROMs in phase IV trials. Conclusions: The use of PROMs in phase IV trials seems to be lower than its use in earlier phases of clinical research. Increased uptake of PROMs in RWE studies can be facilitated in a number of ways including the development of standards for their collection, analysis and use.