Johns Hopkins School of Medicine, 624 N. Broadway, Room 649, Baltimore, MD, 21205, USA.
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Qual Life Res. 2019 Feb;28(2):345-356. doi: 10.1007/s11136-018-2020-3. Epub 2018 Oct 10.
PURPOSE: Patient-reported outcomes (PROs) can promote patient-centered care in multiple ways: (1) using an individual patient's PRO data to inform his/her management, (2) providing PRO results from comparative research studies in patient educational materials/decision aids, and (3) reporting PRO results from comparative research studies in peer-reviewed publications. Patients and clinicians endorse the value of PRO data; however, variations in how PRO measures are scored and scaled, and in how the data are reported, make interpretation challenging and limit their use in clinical practice. We conducted a modified Delphi process to develop stakeholder-engaged, evidence-based recommendations for PRO data display for the three above applications to promote understanding and use. METHODS: The Consensus Panel included cancer survivors/caregivers, oncologists, PRO researchers, and application-specific end-users (e.g., electronic health record vendors, decision aid developers, journal editors). We reviewed the data display issues and their evidence base during pre-meeting webinars. We then surveyed participants' initial perspectives, which informed discussions during an in-person meeting to develop consensus statements. These statements were ratified via a post-meeting survey. RESULTS: Issues addressed by consensus statements relevant to both individual and research data applications were directionality (whether higher scores are better/worse) and conveying score meaning (e.g., none/mild/moderate/severe). Issues specific to individual patient data presentation included representation (bar charts vs. line graphs) and highlighting possibly concerning scores (absolute and change). Issues specific to research study results presentation included handling normed data, conveying statistically significant differences, illustrating clinically important differences, and displaying proportions improved/stable/worsened. CONCLUSIONS: The recommendations aim to optimize accurate and meaningful interpretation of PRO data.
目的:患者报告结局(PRO)可以通过多种方式促进以患者为中心的护理:(1)使用个体患者的 PRO 数据为其治疗提供信息,(2)在患者教育材料/决策辅助工具中提供来自比较研究的 PRO 结果,以及(3)在同行评议出版物中报告来自比较研究的 PRO 结果。患者和临床医生都认可 PRO 数据的价值;然而,PRO 测量的评分和标度以及数据报告方式的差异使得解释变得具有挑战性,并限制了它们在临床实践中的使用。我们采用改良 Delphi 流程,制定了针对上述三种应用的利益相关者参与式、基于证据的 PRO 数据展示推荐意见,以促进理解和使用。
方法:共识小组包括癌症幸存者/照顾者、肿瘤学家、PRO 研究人员和特定应用的最终用户(例如,电子健康记录供应商、决策辅助工具开发者、期刊编辑)。我们在会前网络研讨会期间审查了数据显示问题及其证据基础。然后,我们调查了参与者的初始观点,这些观点为在现场会议上进行讨论以制定共识声明提供了信息。这些声明通过会后调查得到了认可。
结果:共识声明中涉及个体和研究数据应用的问题包括方向性(分数越高是更好还是更差)和传达分数的含义(例如,无/轻度/中度/重度)。与个体患者数据呈现相关的特定问题包括表示(条形图与折线图)和突出可能令人关注的分数(绝对值和变化)。与研究结果呈现相关的特定问题包括处理标准化数据、传达具有统计学意义的差异、说明具有临床意义的差异以及显示改善/稳定/恶化的比例。
结论:这些建议旨在优化 PRO 数据的准确和有意义的解释。
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