Validity arguments for patient-reported outcomes: justifying the intended interpretation and use of data

Background 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. Methods 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. Results 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. Conclusions 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.

Opening, Closing, and Moving through Interpretive Disputes

Chapter 8 explores how the interpretive stases are logically related to each other and how interpretive disputes are initiated and resolved. The chapter explains how the interpretive stases occur in a predictable, presuppositional sequence in which certain interpretive issues must be resolved or settled before further interpretive issues can be considered. The chapter also discusses what happens when additional passages or texts are brought in to support an argument about another passage or text. Passages from Margaret Fell’s seventeenth-century pamphlet arguing for women’s right to preach illustrate these points. Building on Patricia Roberts-Miller’s framework for understanding deliberative conflicts, the chapter outlines four different types of interpretive communities based on their valuation and use of disagreement and interpretive argument. Each of these types of communities initiates and resolves interpretive disputes in different ways. The chapter also describes three constraining factors that influence the felt need to resolve an interpretive disagreement.

How to Use This Book

This chapter offers the reader advice on what to expect from and how make the most of this book. Each chapter is designed to straddle an encyclopedic presentation of the textual and material history of individual letter collections, and an interpretive argument about the way(s) that each collection presents its author.

The Ecology of the Spoken Word

This book offers the first theoretical and experiential translation of Napo Runa mythology in English. It presents and analyzes lowland Quichua speakers in the Napo province of Ecuador through narratives, songs, curing chants, and other oral performances, so readers may come to understand and appreciate Quichua aesthetic expression. Like many other indigenous peoples, the Napo Runa create meaning through language and other practices that do not correspond to the communicative or social assumptions of Western culture. Language itself is only a part of a communicative world that includes plants, animals, and the landscape. In the Napo Runa worldview, storytellers are shamans who use sound and form to create relationships with other people and beings from the natural and spirit worlds. Guiding readers into Quichua ways of thinking and being—in which language itself is only a part of a communicative world that includes plants, animals, and the landscape—the book weaves exacting translations into an interpretive argument with theoretical implications for understanding oral traditions, literacy, new technologies, and language.