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 1-Eliciting Concepts for a New PRO Instrument
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 1-Eliciting Concepts for a New PRO Instrument
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DOI：
10.1016/j.jval.2011.06.014
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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人员或用户声称要评估的概念的重要方面。PRO工具测量与患者的状况及其治疗最重要和最相关的概念。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。ISPOR PRO良好研究规范工作组报告分为两部分，将讨论为新开发的医疗产品评价PRO工具开发内容并评估受访者对该工具的理解。主题包括生成项目的方法，记录项目开发，项目生成的定性数据编码，认知访谈，并通过研究的各个阶段跟踪项目开发，并准备提交给监管机构的跟踪。第1部分涵盖了使用定性焦点小组和/或访谈的关键概念的启发，为新的PRO工具的内容和结构提供信息。第2部分涵盖了工具开发过程，使用认知访谈评估患者对工具草案的理解以及工具修订的步骤。这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 that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant 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. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices 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.