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当前囊性纤维化的临床试验是否符合患者和临床医生的重点?一项系统评价。

Do current clinical trials in cystic fibrosis match the priorities of patients and clinicans? A systematic review.

机构信息

Evidence Based Child Health Group, University of Nottingham, UK.

Evidence Based Child Health Group, University of Nottingham, UK.

出版信息

J Cyst Fibros. 2020 Jan;19(1):26-33. doi: 10.1016/j.jcf.2019.06.005. Epub 2019 Jun 22.

Abstract

There are many uncertainties regarding Cystic Fibrosis (CF) treatment. Recently, the first James Lind Alliance (JLA) Priority Setting Partnership (PSP) in CF was completed, bringing clinicians, patients and carers together to identify the Top 10 research priorities. Here we investigate how well the current clinical trials landscape reflects these priorities. Trials in CF were identified through searches of research databases (Pubmed, ANZCTR, EU clinical trials register, ClinicalTrials.gov and ISRCTN). Trials meeting inclusion criteria of registered intervention studies in CF published between 01.012016 and 11.09.2017 were matched to the Top 10 priorities. We identified 259 trials, with 193 fulfilling the inclusion criteria. Only 63 (33%) of these matched one or more of the JLA priorities showing that current clinical trials poorly reflect the JLA Top 10. By increasing awareness of the Top 10 priorities, it is hoped that this will fuel future research in areas important to the CF community.

摘要

囊性纤维化(CF)的治疗存在诸多不确定性。最近,首个詹姆斯林德联盟(JLA)囊性纤维化优先设定伙伴关系(PSP)完成,汇集了临床医生、患者和护理人员,以确定前 10 项研究重点。在这里,我们研究了当前临床试验领域如何反映这些重点。通过搜索研究数据库(PubMed、ANZCTR、欧盟临床试验注册处、ClinicalTrials.gov 和 ISRCTN),确定了 CF 中的试验。试验符合 2016 年 1 月 1 日至 2017 年 9 月 11 日期间发表的 CF 注册干预研究的纳入标准。将这些试验与前 10 项重点进行匹配。我们确定了 259 项试验,其中 193 项符合纳入标准。只有 63 项(33%)符合 JLA 优先事项中的一项或多项,这表明当前的临床试验未能很好地反映 JLA 的前 10 项重点。通过提高对前 10 项重点的认识,希望这将推动 CF 社区重要领域的未来研究。

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