英国癌症临床试验中患者报告结局（PRO）方案内容及报告的系统评价：EPiC研究方案
Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol.
作者信息
Ahmed Khaled, Kyte Derek, Keeley Thomas, Efficace Fabio, Armes Jo, Brown Julia M, Calman Lynn, Copland Chris, Gavin Anna, Glaser Adam, Greenfield Diana M, Lanceley Anne, Taylor Rachel, Velikova Galina, Brundage Michael, Mercieca-Bebber Rebecca, King Madeleine T, Calvert Melanie
机构信息
Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.
出版信息
BMJ Open. 2016 Sep 21;6(9):e012863. doi: 10.1136/bmjopen-2016-012863.
INTRODUCTION
Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported.
HYPOTHESIS
Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.
METHODS AND ANALYSIS
Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.
ETHICS AND DISSEMINATION
The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r).
TRIAL REGISTRATION NUMBER
PROSPERO CRD42016036533.
引言
新出现的证据表明，患者报告结局（PRO）相关信息可能在试验方案中被遗漏，且PRO结果的报告质量较差，这限制了PRO数据在癌症护理中的应用。本研究旨在评估英国癌症试验方案及其相关出版物中PRO特定内容的标准，并突出最佳实践的PRO方案内容及报告的实例。本研究的目的是确定这些早期发现是否适用于英国癌症试验，如果适用，我们如何才能在未来改进临床试验方法，以提高PRO评估、管理和报告的方式。
假设
主要终点基于PRO的试验将比PRO为次要终点的试验具有更完整的PRO方案和出版物组成部分。
方法与分析
如果包含主要/次要PRO终点，则纳入已完成的英国国家卫生研究院（NIHR）投资组合癌症临床试验（所有癌症专科/年龄组）。NIHR投资组合包括由一系列资助者支持的癌症试验，这些试验被判定为高质量的临床研究。样本将从2000年12月31日至2014年3月1日期间完成的研究中抽取（n = 1141），以便有足够时间完成最终试验报告和发表。然后，两名评审员将审查纳入试验的方案及其相关出版物，以：（1）确定其PRO特定方案内容的完整性；（2）确定英国癌症试验中PRO报告的比例和完整性；（3）模拟与PRO方案和报告完整性以及PRO报告比例相关的因素。
伦理与传播
该研究获得了伯明翰大学伦理委员会的批准（ERN_15 - 0311）。试验结果将通过在地方、国家和国际会议上的报告、同行评审期刊以及社交媒体（包括CPROR推特账户和伯明翰大学部门网站（http://www.birmingham.ac.uk/cpro0r））进行传播。
试验注册号
PROSPERO CRD42016036533。
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