ArticleJournal of patient-reported outcomes2021
Validity arguments for patient-reported outcomes: justifying the intended interpretation and use of data.
Article in Journal of patient-reported outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Person-centered care assessment tool with a focus on quality healthcare: a systematic review of psychometric properties.BMC psychology · 2024Pooled it
- Measurement validity: essential in principle, subordinated in practice.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- Developing a validity testing plan for a patient-reported outcome measure in a new context using the argument-based approach to validity.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- The argument-based approach to validity: theory, assumptions, evidence, and consequences.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- A Validation Study of the Female Sexual Function Index for Use in Pregnant and Postpartum Samples.Archives of sexual behavior · 2026Article
- Carers' interpretation of the recall period and perspective-taking when completing the EQ health and wellbeing instrument (EQ-HWB)-9 as proxies for people with dementia: a think-aloud study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- Exploring patient interpretation of an orthosis adherence checklist: A cognitive interview study.PloS one · 2026Article
- Validity evidence for the use of the Pediatric Quality of Life Inventory, the Revised Children's Anxiety and Depression Scale-25, and the Columbia-Suicide Severity Rating Scale in measurement-based care in intensive outpatient child and adolescent mental health care.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
- Experimental Therapeutics: Opportunities and Challenges Stemming From the National Institute of Mental Health Workshop on Novel Target Discovery and Psychosocial Intervention Development.Perspectives on psychological science : a journal of the Association for Psychological Science · 2025Article
- Quantifying the Degree of Fatigue in People Reporting Symptoms of Post-COVID-19 Syndrome: Results from a Rasch Analysis.Physiotherapy Canada. Physiotherapie Canada · 2025Article
- Measuring health literacy to inform actions to address health inequities: a cluster analysis approach based on the Australian national health literacy survey.Journal of public health (Oxford, England) · 2024Article
- Measuring what matters to older persons for active living: part II cross-sectional validity evidence for OPAL measure across four countries.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024Article
- Profiles of health literacy and digital health literacy in clusters of hospitalised patients: a single-centre, cross-sectional study.BMJ open · 2024Article
- Psychometric evaluation of the respiratory syncytial virus infection, intensity and impact questionnaire (RSV-iiiQ) in adults.Health and quality of life outcomes · 2024Article
- The Parent Health Literacy Questionnaire (HLQ-Parent). Adaptation and validity testing with parents of children with epilepsy.Scandinavian journal of public health · 2024Article
- Health literacy strengths and challenges of people in New South Wales prisons: a cross-sectional survey using the Health Literacy Questionnaire (HLQ).BMC public health · 2023Article
- Implications of the syntheses on definition, theory, and methods conducted by the Response Shift - in Sync Working Group.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- The impact of COVID-19 on sleep for autistic children: A systematic review.Research in autism spectrum disorders · 2023Review
- Use of the English Health Literacy Questionnaire (HLQ) with Health Science University Students in Nepal: A Validity Testing Study.International journal of environmental research and public health · 2022Article
- Validity Testing and Cultural Adaptation of the eHealth Literacy Questionnaire (eHLQ) Among People With Chronic Diseases in Taiwan: Mixed Methods Study.Journal of medical Internet research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundContrary 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.
methodsThe 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.
resultsThe 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.
conclusionsKane'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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.