Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Avenue, JJN3, Cleveland, OH, 44195, USA.
Center for Outcomes Research and Evaluation, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
J Patient Rep Outcomes. 2023 Jun 2;7(1):52. doi: 10.1186/s41687-023-00588-6.
Many large-scale population-based surveys, research studies, and clinical care allow for inclusion of proxy reporting as a strategy to collect outcomes when patients are unavailable or unable to provide reliable self-report. Prior work identified an absence of methodological guidelines regarding proxy reporting in adult populations, including who can serve as a proxy, and considerations for data collection, analysis, and reporting. The primary objective of this work by the ISOQOL Proxy Task Force was to review documents and clinical outcome assessment measures with respect to proxy reporting and to develop, through consensus, considerations for proxy reporting.
We assembled an international group with clinically relevant and/or methodological expertise on proxy use in adult populations. We conducted a targeted review of documentation based on regulatory, non-regulatory, professional society, and individual measure sources. Using a standardized collection form, proxy-related information was extracted from each source including definitions of a proxy, characteristics of a proxy, domains addressable or addressed by a proxy, and observer-reporting.
The definition of proxy was inconsistent across 39 sources, except regulatory documents which defined a proxy as a person other than the patient who reports on an outcome as if she/he were the patient. While proxy report was discouraged in regulatory documentation, it was acknowledged there were instances where self-report was impossible. Many documentation sources indicated proxies would be well-justified in certain contexts, but did not indicate who could act as a proxy, when proxies could be used, what domains of patient health they could report on, or how data should be reported. Observer-reported outcomes were typically defined as those based on observed behaviors, however there was not a consistent differentiation between proxy and observer reporting. Based on information extracted from these resources, we developed a checklist of considerations when including proxy-reported measures or using proxies in study design, data collection, analysis, interpretation and reporting of proxy reported data.
Our targeted review highlights a lack of clarity in capturing, interpreting and reporting data from proxies in adult populations. We provide a checklist of considerations to assist researchers and clinicians with including proxies in research studies and clinical care. Lastly, our review identified areas where further guidance and future research are necessary.
许多大规模的基于人群的调查、研究和临床护理都允许使用代理报告作为策略，以在患者无法或无法提供可靠的自我报告时收集结果。先前的工作发现，成人人群中缺乏关于代理报告的方法学指南，包括谁可以作为代理，以及数据收集、分析和报告的注意事项。ISOQOL 代理工作组的主要目标是审查有关代理报告的文件和临床结果评估措施，并通过共识制定代理报告的注意事项。
我们组建了一个由具有成人人群中代理使用相关临床和/或方法学专业知识的国际团队。我们针对监管、非监管、专业协会和个别措施来源进行了有针对性的文件审查。使用标准化的收集表格，从每个来源提取与代理相关的信息，包括代理的定义、代理的特征、代理可解决或已解决的领域以及观察员报告。
39 个来源中代理的定义不一致，监管文件除外，这些文件将代理定义为除患者以外的报告患者结果的人，就好像她/他是患者一样。尽管监管文件不鼓励代理报告，但也承认在某些情况下自我报告是不可能的。许多文件来源表明，在某些情况下，代理是合理的，但没有说明谁可以担任代理，何时可以使用代理，他们可以报告患者健康的哪些领域，或者如何报告数据。观察员报告的结果通常被定义为基于观察到的行为，但没有明确区分代理和观察员报告。根据从这些资源中提取的信息，我们制定了一份在纳入代理报告的措施或在研究设计、数据收集、分析、解释和报告代理报告的数据时需要考虑的因素清单。
我们的针对性审查强调了在成人人群中捕获、解释和报告代理数据时缺乏明确性。我们提供了一份考虑因素清单，以帮助研究人员和临床医生将代理纳入研究和临床护理。最后，我们的审查确定了需要进一步指导和未来研究的领域。
