Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
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DOI：
10.1371/journal.pone.0110216
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
King M
中科院分区：
文献类型：
--
作者：
Calvert M;Kyte D;Duffy H;Gheorghe A;Mercieca-Bebber R;Ives J;Draper H;Brundage M;Blazeby J;King M
有证据表明，在临床试验中，患者报告的结果(PRO)评估和报告存在不一致之处，这可能会限制使用这些数据来为患者护理提供信息。对于有PRO终点的试验，常规地将关键PRO信息包括在方案中可能有助于改善试验进行以及PRO结果的报告和评估；然而，目前还不清楚到底应该包括哪些PRO特定信息。这篇综述的目的是总结当前针对临床试验方案开发者的PRO-特异性指南。我们检索了MEDLINE、EMBASE、CINHAL和Cochrane图书馆数据库(INSTATION至2013年2月)，以获得关于试验方案制定的专业指导。通过谷歌、谷歌学者、英国临床研究协作注册临床试验单位成员和国际专家的请求确定了进一步的指导文件。两名独立调查员进行了标题/摘要筛选、全文审查和数据提取，第三名调查员参与了意见分歧的情况。对21,175条引文进行了筛选，其中54条符合纳入标准。指导文件很难查阅：电子数据库搜索只找到8份文件，其余46份来自其他地方(5份来自引文跟踪，27份来自手工搜索，7份来自灰色文献审查，7份来自专家)。从所包括的文件中提取了162项独特的有利于具体议定书的建议。还确定了与支持试验文件有关的另外10项PRO建议。只有5/162(3%)的建议出现在≥审查的50%的指导文件中，这表明缺乏一致性。针对特定议定书的准则难以获取，缺乏一致性，在实践中可能难以实施。有必要制定易于获得的、以协商一致为导向的PRO议定书指南。指导应旨在确保关键的PRO信息定期包括在适当的试验方案中，以便促进PRO数据的严格收集/报告，从而有效地为患者护理提供信息。
Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care.
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影响因子：
3.5
作者：
CELLA, DF;WIKLUND, I;AARONSON, NK
通讯作者：
AARONSON, NK
影响因子：
3
作者：
Brooks, MM;Jenkins, LS;Paeth, DS
通讯作者：
Paeth, DS
影响因子：
45.3
作者：
Buchanan, DR;O'Mara, AM;Minasian, LM
通讯作者：
Minasian, LM
DOI：
10.1046/j.0269-4727.2003.00520.x
发表时间：
2004-02-01
影响因子：
2
作者：
Calvert, MJ;Freemantle, N
通讯作者：
Freemantle, N
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D