背景:在过去的几十年里,患者报告结果(PRO)已被用于更好地了解患者的健康状况.因此,已经制定了许多PRO措施(问卷)和准则或指南。然而,从许多可用的指导中选择目标指导并理解所选择的指导是具有挑战性的。这项研究全面收集了现有的PRO临床试验或研究和实践指南,以支持学术界的新手PRO用户,工业,临床实践,以及监管和报销决策。
方法:对于范围审查,我们搜索了MEDLINE,Embase,谷歌图书,WorldCat,以及2009年至2023年的国家医学图书馆(NLM)书架数据库。资格标准是临床试验的PRO指导,临床实践,或卫生技术评估等应用。这些指南涵盖了生活质量(QOL)、PRO,与健康相关的QOL,健康国家公用事业,心理测量要求,实施方法,分析和解释,或临床实践应用。经过系统的搜索,三名研究人员分别审查了收集的数据,审查的文章和书籍使用相同的标准进行审查。
结果:我们收集了2009年至2023年之间在文章和书籍中发布的PRO指南。从数据库搜索,确定了1455篇文章和387本书,其中一本书和33篇文章最终被选中。收集的PRO指南被归类为采用PRO措施,使用PRO设计和报告试验或研究,在临床试验或研究或临床实践中实施PRO评估,PROs的分析和解释,和PRO评估的应用。基于这种分类,对于新手,我们建议如下:在选择指南时,新手应该澄清将使用指南的“地点”和“目的”。此外,他们应该知道,与PRO相关的术语以及PRO的范围和期望因“地点”和“目的”而异。
结论:从对现有PRO指南的范围审查中,我们提供了摘要和警告,以帮助新手选择适合其目的的指南并理解它。
BACKGROUND: Over the past few decades, patient-reported outcomes (PROs) have been used to understand patient health conditions better. Therefore, numerous PRO measures (questionnaires) and guidelines or guidance have been developed. However, it is challenging to select target guidance from among the many available guidance and to understand the chosen guidance. This study comprehensively collected the existing PRO guidance for clinical trials or studies and practices to support novice PRO users in academia, industry, clinical practice, and regulatory and reimbursement decision-making.
METHODS: For the scoping review, we searched the MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf databases from 2009 to 2023. The eligibility criteria were PRO guidance for clinical trials, clinical practice, or application such as health technology assessment. Those guidance cover aspects such as quality of life (QOL), PRO, health-related QOL, health state utilities, psychometric requirements, implementation methods, analysis and interpretation, or clinical practice applications. After the systematic search, three researchers individually reviewed the collected data, and the reviewed articles and books were scrutinized using the same criteria.
RESULTS: We collected the PRO guidance published in articles and books between 2009 and 2023. From the database searches, 1,455 articles and 387 books were identified, of which one book and 33 articles were finally selected. The collected PRO guidance was categorized into the adoption of PRO measures, design and reporting of trials or studies using PROs, implementation of PRO evaluation in clinical trials or studies or clinical practice, analysis and interpretation of PROs, and application of PRO evaluation. Based on this categorization, we suggest the following for novices: When selecting guidance, novices should clarify the \"place\" and \"purpose\" where the guidance will be used. Additionally, they should know that the terminology related to PRO and the scope and expectations of PROs vary by \"places\" and \"purposes\".
CONCLUSIONS: From this scoping review of existing PRO guidance, we provided summaries and caveats to assist novices in selecting guidance that fits their purpose and understanding it.