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癌症核心结局集的制定标准需要改进。

Improvement was needed in the standards of development for cancer core outcome sets.

机构信息

Department of Biostatistics, MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, United Kingdom.

Department of Biostatistics, MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, United Kingdom.

出版信息

J Clin Epidemiol. 2019 Aug;112:36-44. doi: 10.1016/j.jclinepi.2019.04.006. Epub 2019 Apr 19.

DOI:10.1016/j.jclinepi.2019.04.006
PMID:31009657
Abstract

OBJECTIVE

The Core Outcome Set-STAndards for Development (COS-STAD) contains 11 standards (12 criteria) that are deemed to be the minimum design recommendations for all core outcome set (COS) development projects. Cancer is currently the disease area with the highest number of published COSs and is a major cause of worldwide morbidity and mortality. The aim of this study was to provide a baseline of cancer COS standards.

STUDY DESIGN AND SETTING

Systematic reviews of COSs have identified 307 published COS studies. Cancer COSs were eligible for inclusion. Two reviewers independently assessed each of the COSs against the 12 criteria.

RESULTS

Forty-nine cancer COSs were included; none met all 12 criteria representing the 11 minimum standards assessed in this study (range = 4-11 criteria, median = 6 criteria). All studies met the four scope standards, eight (16%) met all three standards for stakeholders involved, and two (4%) met all four standards for consensus process standards.

CONCLUSION

With the exception of "scope" specification, there is much need for improvement. Poor reporting often made it challenging to assess whether minimum standards were met. The consensus process criteria were most difficult to assess, particularly those that required an assessment of being a priori. This is the first application of COS-STAD criteria to studies that have developed COSs and provides a baseline of cancer COS standards of development.

摘要

目的

核心结局集-标准制定(COS-STAD)包含 11 项标准(12 个标准),被认为是所有核心结局集(COS)开发项目的最低设计建议。癌症是目前发表的 COS 数量最多的疾病领域,也是全球发病率和死亡率的主要原因。本研究旨在提供癌症 COS 标准的基线。

研究设计和设置

对 COS 的系统评价确定了 307 项已发表的 COS 研究。癌症 COS 有资格纳入。两名审查员独立评估了每一项 COS 对 12 项标准的符合情况。

结果

纳入了 49 项癌症 COS,没有一项符合所有 12 项标准,代表了本研究评估的 11 项最低标准(范围= 4-11 项标准,中位数= 6 项标准)。所有研究都符合四个范围标准,八项(16%)符合涉及的利益相关者的所有三个标准,两项(4%)符合共识过程标准的所有四个标准。

结论

除了“范围”规范外,还有很多需要改进的地方。报告不佳常常使评估是否达到最低标准变得具有挑战性。共识过程标准最难评估,特别是那些需要预先评估的标准。这是首次将 COS-STAD 标准应用于开发 COS 的研究,并提供了癌症 COS 发展标准的基线。

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