Hawkins Melanie, Elsworth Gerald R, Nolte Sandra, Osborne Richard H
Swinburne University of Technology, Centre for Global Health and Equity, School of Health Sciences, PO Box 218, Hawthorn, Melbourne, Victoria, 3122, Australia.
Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medical Department, Division of Psychosomatic Medicine, Berlin, Germany.
J Patient Rep Outcomes. 2021 Jul 30;5(1):64. doi: 10.1186/s41687-021-00332-y.
Contrary to common usage in the health sciences, the term "valid" refers not to the properties of a measurement instrument but to the extent to which data-derived inferences are appropriate, meaningful, and useful for intended decision making. The aim of this study was to determine how validity testing theory (the Standards for Educational and Psychological Testing) and methodology (Kane's argument-based approach to validation) from education and psychology can be applied to validation practices for patient-reported outcomes that are measured by instruments that assess theoretical constructs in health.
The Health Literacy Questionnaire (HLQ) was used as an example of a theory-based self-report assessment for the purposes of this study. Kane's five inferences (scoring, generalisation, extrapolation, theory-based interpretation, and implications) for theoretical constructs were applied to the general interpretive argument for the HLQ. Existing validity evidence for the HLQ was identified and collated (as per the Standards recommendation) through a literature review and mapped to the five inferences. Evaluation of the evidence was not within the scope of this study.
The general HLQ interpretive argument was built to demonstrate Kane's five inferences (and associated warrants and assumptions) for theoretical constructs, and which connect raw data to the intended interpretation and use of the data. The literature review identified 11 HLQ articles from which 57 sources of validity evidence were extracted and mapped to the general interpretive argument.
Kane's five inferences and associated warrants and assumptions were demonstrated in relation to the HLQ. However, the process developed in this study is likely to be suitable for validation planning for other measurement instruments. Systematic and transparent validation planning and the generation (or, as in this study, collation) of relevant validity evidence supports developers and users of PRO instruments to determine the extent to which inferences about data are appropriate, meaningful and useful (i.e., valid) for intended decisions about the health and care of individuals, groups and populations.
与健康科学中的常用用法相反，“有效”一词并非指测量工具的属性，而是指源自数据的推断在何种程度上适用于预期决策、有意义且有用。本研究的目的是确定教育和心理学领域的效度测试理论（《教育和心理测试标准》）及方法（凯恩基于论证的效度验证方法）如何应用于通过评估健康领域理论构念的工具所测量的患者报告结局的效度验证实践。
本研究以健康素养问卷（HLQ）为例，这是一种基于理论的自我报告评估工具。凯恩针对理论构念的五个推断（评分、概括、外推、基于理论的解释及影响）被应用于HLQ的一般解释性论证。通过文献综述识别并整理（按照标准建议）了HLQ现有的效度证据，并将其映射到这五个推断上。对证据的评估不在本研究范围内。
构建了HLQ的一般解释性论证，以展示凯恩针对理论构念的五个推断（以及相关的保证和假设），这些推断将原始数据与数据的预期解释和用途联系起来。文献综述确定了11篇关于HLQ的文章，从中提取了57个效度证据来源，并将其映射到一般解释性论证上。
针对HLQ展示了凯恩的五个推断以及相关的保证和假设。然而，本研究中开发的过程可能适用于其他测量工具的效度验证规划。系统且透明的效度验证规划以及相关效度证据的生成（或如本研究中的整理）支持患者报告结局工具的开发者和使用者确定关于数据的推断在何种程度上适用于关于个体、群体和人群的健康与护理的预期决策、有意义且有用（即有效）。
