PDF(Pubmed)
Abstract：
BACKGROUND: Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs).
OBJECTIVE: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs\' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs\' implementation in CQRs, which is the aim of the broader project.
METHODS: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs\' implementation will be extracted. A narrative synthesis of included publications will be conducted.
RESULTS: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024.
CONCLUSIONS: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs\' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs\' implementation in CQRs.
BACKGROUND: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x.
UNASSIGNED: DERR1-10.2196/52572.
OBJECTIVE: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs\' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs\' implementation in CQRs, which is the aim of the broader project.
METHODS: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs\' implementation will be extracted. A narrative synthesis of included publications will be conducted.
RESULTS: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024.
CONCLUSIONS: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs\' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs\' implementation in CQRs.
BACKGROUND: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x.
UNASSIGNED: DERR1-10.2196/52572.
摘要：
背景：在全球范围内实施患者报告结果测量（PROM）来测量和评估健康结果正在增加。随着这一新兴趋势，重要的是要确定哪些准则，框架，清单,和建议存在，以及它们是否以及如何用于实施PROM，特别是在临床质量登记处(CQR)。
目的：这篇综述旨在确定现有的出版物，以及讨论实际指南应用的出版物，框架，清单,以及为临床试验等各种目的实施PROM的建议，临床实践，和CQR。此外,确定的出版物将用于指导在CQR中实施PROM的新指南的制定，这是更广泛项目的目标。
方法：对MEDLINE数据库进行文献检索，Embase,CINAHL,PsycINFO,和Cochrane中央对照试验登记册将自数据库建立以来进行，除了使用谷歌学者和灰色文献来识别用于范围审查的文献。预定义的纳入和排除标准将用于筛选的所有阶段。现有的准则出版物，框架，清单,recommendations,和出版物讨论了这些方法在临床试验中实施PROM的应用，临床实践，和CQR将包括在最终审查中。与书目信息有关的数据，目标,PROM使用的目的(临床试验，实践,或注册表)，准则名称,框架,清单和建议，发展的理由，它们的目的和含义将被提取出来。此外,对于实际方法的出版物，将提取PROM实施的方面或域。将对所包括的出版物进行叙述性综合。
结果：电子数据库搜索于2024年3月完成。标题和摘要筛选，全文筛选,数据提取将于2024年5月完成。审查预计将于2024年8月底完成。
结论：本次范围审查的结果将为在临床试验中实施PROM的任何现有方法和工具提供证据，临床实践，和CQR。预计这些出版物将帮助我们指导在CQR中实施PROM的新指南的制定。
背景：PROSPEROCRD42022366085;https://tinyurl.com/bdesk98x。
■DERR1-10.2196/52572。
目的：这篇综述旨在确定现有的出版物，以及讨论实际指南应用的出版物，框架，清单,以及为临床试验等各种目的实施PROM的建议，临床实践，和CQR。此外,确定的出版物将用于指导在CQR中实施PROM的新指南的制定，这是更广泛项目的目标。
方法：对MEDLINE数据库进行文献检索，Embase,CINAHL,PsycINFO,和Cochrane中央对照试验登记册将自数据库建立以来进行，除了使用谷歌学者和灰色文献来识别用于范围审查的文献。预定义的纳入和排除标准将用于筛选的所有阶段。现有的准则出版物，框架，清单,recommendations,和出版物讨论了这些方法在临床试验中实施PROM的应用，临床实践，和CQR将包括在最终审查中。与书目信息有关的数据，目标,PROM使用的目的(临床试验，实践,或注册表)，准则名称,框架,清单和建议，发展的理由，它们的目的和含义将被提取出来。此外,对于实际方法的出版物，将提取PROM实施的方面或域。将对所包括的出版物进行叙述性综合。
结果：电子数据库搜索于2024年3月完成。标题和摘要筛选，全文筛选,数据提取将于2024年5月完成。审查预计将于2024年8月底完成。
结论：本次范围审查的结果将为在临床试验中实施PROM的任何现有方法和工具提供证据，临床实践，和CQR。预计这些出版物将帮助我们指导在CQR中实施PROM的新指南的制定。
背景：PROSPEROCRD42022366085;https://tinyurl.com/bdesk98x。
■DERR1-10.2196/52572。
