Content Validity-Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2-Assessing Respondent Understanding
Content Validity-Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2-Assessing Respondent Understanding
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DOI：
10.1016/j.jval.2011.06.013
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发表时间：
2011-12-01
期刊：
影响因子：
4.5
通讯作者：
Ring, Lena
中科院分区：
文献类型：
--
作者：
Patrick, Donald L.;Burke, Laurie B.;Ring, Lena
美国食品药品监督管理局和欧洲药品管理局都强调了内容效度在开发患者报告结局（PRO）工具中的重要性。内容有效性是指工具在多大程度上衡量了开发者或使用者声称要评估的概念的重要方面。PRO仪器测量与患者的状况及其治疗最相关和最重要的概念。对于PRO工具，工具评分中反映的项目和领域对目标人群应该是重要的，并且对患者问题应该是全面的。记录目标人群在项目生成中的输入，以及通过认知访谈评估患者的理解，可以为内容效度提供证据。本工作队报告的第1部分包括利用定性焦点小组和/或访谈来引出关键概念，以告知新的PRO工具的内容和结构。基于定性访谈和焦点小组用于引出概念，认知访谈帮助开发人员制作可以被目标人群中的受访者理解的项目，并最终确认最终工具在目标人群中是适当的，全面的和可理解的。第2部分详细信息：1）进行认知访谈的方法，以解决患者对项目，说明和响应选项的理解; 2）通过研究的各个阶段跟踪项目开发的方法，并准备将此跟踪提交给监管机构。特别工作组报告的两个部分应该放在一起阅读。它们旨在为计划、执行和记录定性研究的良好实践提供建议，这些研究用于支持医疗产品评价中使用的PRO工具的内容有效性。
The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts developers or users purport it to assess. A PRO instrument measures the concepts most relevant and important to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Part 1 of this task force report covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Building on qualitative interviews and focus groups used to elicit concepts, cognitive interviews help developers craft items that can be understood by respondents in the target population and can ultimately confirm that the final instrument is appropriate, comprehensive, and understandable in the target population. Part 2 details: 1) the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and 2) the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. The task force report's two parts are meant to be read together. They are intended to offer suggestions for good practice in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.