晚期疾病随机对照癌症试验中的患者报告结局：一项结构化文献综述
Patient reported outcomes in randomized controlled cancer trials in advanced disease: a structured literature review.
作者信息
Weingärtner V, Dargatz N, Weber C, Mueller D, Stock S, Voltz R, Gaertner J
机构信息
a Department of Palliative Medicine, Clinical Trials Unit and Center for Integrated Oncology (CIO) Cologne/Bonn , University Hospital of Cologne , Cologne , Germany.
b Institute of Health Economics and Clinical Epidemiology (IGKE) , University Hospital of Cologne , Cologne , Germany.
出版信息
Expert Rev Clin Pharmacol. 2016 Jun;9(6):821-9. doi: 10.1586/17512433.2016.1164595. Epub 2016 Apr 7.
INTRODUCTION
In advanced cancer quality of life (QoL) is the most important goal of care. It is measured by patient-reported-outcomes (PRO). This structured review evaluated how randomized controlled trials (RCTs) on anti-cancer therapy in advanced cancer reported PRO.
METHODS
Search was performed in MEDLINE via PubMed for RCTs with median patient survival of ≤2 years. Reporting was rated with the Consolidated Standards of Reporting Trials (CONSORT) PRO extension.
RESULTS
Of 370 retrieved publications, 117 were eligible, but only 30/117 (26%) reported PRO. QoL was most frequently measured (29/30). On average, 4.4 (SD 2.5) of the 14 CONSORT items were met.
CONCLUSION
PRO are insufficiently reported in advanced cancer trials. Yet, this is paramount to enable an informed and patient-oriented decision making process.
引言
在晚期癌症中，生活质量（QoL）是最重要的护理目标。它通过患者报告结局（PRO）来衡量。本结构化综述评估了晚期癌症抗癌治疗的随机对照试验（RCT）中PRO的报告情况。
方法
通过PubMed在MEDLINE中检索中位患者生存期≤2年的RCT。报告采用试验报告统一标准（CONSORT）PRO扩展版进行评分。
结果
在检索到的370篇出版物中，117篇符合条件，但只有30/117（26%）报告了PRO。生活质量是最常测量的指标（29/30）。14项CONSORT项目平均满足4.4项（标准差2.5）。
结论
晚期癌症试验中PRO的报告不足。然而，这对于实现明智且以患者为导向的决策过程至关重要。
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