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患者报告结局指标测量属性研究的COSMIN报告指南:第2.0版。

COSMIN reporting guideline for studies on measurement properties of patient‑reported outcome measures: version 2.0.

作者信息

Gagnier Joel J, de Arruda Guilherme Tavares, Terwee Caroline B, Mokkink Lidwine B

机构信息

Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.

Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.

出版信息

Qual Life Res. 2025 Mar 28. doi: 10.1007/s11136-025-03950-x.

DOI:10.1007/s11136-025-03950-x
PMID:40153128
Abstract

PURPOSE

In 2021 a set of consensus-based and empirically informed reporting recommendations were developed for primary studies of the measurement properties of patient‑reported outcome measures (PROMs). With their use, we determined that certain reporting items were redundant, some required revisions, and additional items were needed. The aim of this study was to update the COSMIN reporting guideline and develop version 2.0 for studies on measurement properties of PROMs.

METHODS

There were seven phases to this update: 1. Identification of relevant experts for the meeting; 2. Solicitation of written feedback on the existing reporting recommendations checklist; 3. Development of the Explanation & Elaboration document; 4. A face-to-face consensus meeting; 5. Post-meeting revisions of the checklist and Explanation & Elaboration document; 6. Circulation of the resultant manuscripts to experts for solicitation of final feedback, and 7. Completion of the final documents and resultant manuscripts, distribution to all members for approval, and finalization.

RESULTS

Overall, the revised recommendations for version 2.0 consists of 31 general items and 37 specific items. Of the general items, 15 were revised or reordered and one item was added. Of the specific items, 15 were revised or reordered and two new items were added.

CONCLUSION

We recommend that the earlier version of this guidance (version 1.0) no longer be used. These revised reporting recommendations (version 2.0) will help to guide those reporting or reading these investigations on the essential information that is recommended to be included.

摘要

目的

2021年,针对患者报告结局测量指标(PROMs)测量属性的原始研究,制定了一套基于共识和实证的报告建议。通过使用这些建议,我们确定某些报告项目是多余的,一些需要修订,还需要增加其他项目。本研究的目的是更新COSMIN报告指南,并为PROMs测量属性的研究制定2.0版。

方法

本次更新有七个阶段:1. 确定会议相关专家;2. 征求对现有报告建议清单的书面反馈;3. 制定解释与阐述文件;4. 召开面对面共识会议;5. 会后对清单和解释与阐述文件进行修订;6. 将最终稿件分发给专家征求最终反馈;7. 完成最终文件和稿件,分发给所有成员批准并定稿。

结果

总体而言,2.0版的修订建议包括31个一般项目和37个具体项目。在一般项目中,15个项目进行了修订或重新排序,增加了1个项目。在具体项目中,15个项目进行了修订或重新排序,增加了2个新项目。

结论

我们建议不再使用该指南的早期版本(1.0版)。这些修订后的报告建议(2.0版)将有助于指导报告或阅读这些调查的人员了解建议纳入的基本信息。

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