University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria
University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria.
BMJ Open. 2024 Sep 10;14(9):e084935. doi: 10.1136/bmjopen-2024-084935.
There are different modes and ways to assess patient-reported outcomes (PROs) in clinical trials. However, there is little systematic information on how often different modes of assessment (MOA) are used in cancer clinical trials and how exactly assessments are conducted. The goal of this scoping review is to gain an understanding of the MOA and data management of PROs in cancer randomised controlled trials (RCTs) and the reporting quality thereof.
This scoping review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Relevant trials will be identified via their indexed publications. We will search PubMed for RCTs conducted in cancer populations that evaluate a biomedical treatment with a PRO endpoint. Trials with publications published between January 2019 and November 2023 will be included. Two independent reviewers will review the references for both the abstract and full-text screening. We will extract data from the publications from a trial and the trial protocol if a protocol can be traced. Data will be summarised at the trial level. We will focus on a descriptive analysis of the MOA of PROs and on the relative frequencies of the different MOA. We will also evaluate the quality of reporting for the relevant SPIRIT and CONSORT guidelines that refer to the assessment of PROs in trials. Due to the scoping nature of our review, we will not perform a dedicated quality assessment of all trials.
The proposed review is based on secondary, published data. Hence, no ethics review is necessary. The review is part of an ongoing project on the use of electronic data capture methods in cancer clinical trials. The findings from the review will support the project and contribute to synthesising guidance to ultimately improve the (electronic) measurement of patient-reported outcome measures in clinical trials.
在临床试验中，有不同的模式和方法来评估患者报告的结局（PROs）。然而，关于不同评估模式（MOA）在癌症临床试验中使用的频率以及评估的具体方式，系统信息很少。本综述的目的是了解癌症随机对照试验（RCT）中 PRO 的 MOA 和数据管理及其报告质量。
本综述方案遵循系统评价和荟萃分析的首选报告项目指南。将通过索引出版物识别相关试验。我们将在 PubMed 中搜索评估生物医学治疗与 PRO 结局的癌症人群中的 RCT。将纳入发表于 2019 年 1 月至 2023 年 11 月期间的出版物的试验。两名独立的审查员将对摘要和全文筛选的参考文献进行审查。如果可以追踪到方案，我们将从出版物和试验方案中提取数据。数据将在试验水平上进行总结。我们将重点对 PRO 的 MOA 进行描述性分析，并对不同 MOA 的相对频率进行分析。我们还将评估与 PROs 评估相关的 SPIRIT 和 CONSORT 指南的报告质量。由于我们的综述具有范围界定的性质，因此不会对所有试验进行专门的质量评估。
拟议的综述基于已发表的二手数据。因此，不需要进行伦理审查。该综述是正在进行的癌症临床试验中电子数据采集方法使用项目的一部分。综述结果将支持该项目，并有助于综合指导意见，最终改善临床试验中患者报告结局测量的（电子）方法。
