ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2018
Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity.
Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04016298 (Validation of Bladder Health Instrument for Evaluation in Women), which is not on this map. Cited by 71 papers, 3 of them syntheses that pooled it.
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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.
Validation of Bladder Health Instrument for Evaluation in Women
Who cites it
71 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- A worldwide itinerary of research ethics in science for a better social responsibility and justice: a bibliometric analysis and review.Frontiers in research metrics and analytics · 2025Pooled it
- Research areas and trends in family-centered care in the 21st century: a bibliometric review.Frontiers in medicine · 2024Pooled it
- Approaches to the development of new screening tools that assess distress in Indigenous peoples: A systematic mixed studies review.PloS one · 2023Pooled it
- Patient-Reported Outcome Measures in the Emergency Department: A Scoping Review.Journal of the American College of Emergency Physicians open · 2026Review
- Development and validation of a rapid health literacy assessment tool for Chinese primary and secondary school students.Health promotion international · 2026Article
- Item comprehension and content coverage of patient-reported outcome measures for long COVID: a qualitative study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- Translation and cultural adaptation of the health literacy questionnaire (HLQ) in Morocco.Journal of patient-reported outcomes · 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
- Discrepancies in the country versions of the WHOQOL-BREF as a potential source of error in assessing quality of life and a barrier to comparative research.Health and quality of life outcomes · 2026Article
- Article
- Development and psychometric properties of the 'Assessment of Burden of Chronic Conditions (ABCC) tool' for people with chronic heart failure (CHF): a mixed methods approach.Family medicine and community health · 2026Article
- Assessing biopsychosocial status in people living with HIV: validity, reliability, and responsiveness of BETY-BQ.BMC infectious diseases · 2026Article
- Development and validation of an enhanced PERCCI-S (PERCCI-S-Rev) for measuring person-centred home-based primary care.Frontiers in health services · 2026Article
- Actual macronutrient composition of the Mediterranean diet and its association with adiposity and inflammation: a cross-sectional real-life study.Journal of translational medicine · 2025Article
- Psychometric properties, and cultural appropriateness, of patient reported outcome measures for use in primary healthcare: a scoping review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
- Voices that matter: The impact of patient-reported outcome measures on clinical decision-making.World journal of methodology · 2025Review
- The comprehensibility continuum: a novel method for analysing comprehensibility of patient reported outcome measures.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
- [Measuring health literacy: methods and tools for assessing general health literacy in adults].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2025Review
- Health Literacy and Self-Efficacy in Parents of Toddlers-A Cross-Sectional Study.Nursing open · 2025Article
11 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundData from subjective patient-reported outcome measures (PROMs) are now being used in the health sector to make or support decisions about individuals, groups and populations. Contemporary validity theorists define validity not as a statistical property of the test but as the extent to which empirical evidence supports the interpretation of test scores for an intended use. However, validity testing theory and methodology are rarely evident in the PROM validation literature. Application of this theory and methodology would provide structure for comprehensive validation planning to support improved PROM development and sound arguments for the validity of PROM score interpretation and use in each new context.
objectiveThis paper proposes the application of contemporary validity theory and methodology to PROM validity testing. ILLUSTRATIVE EXAMPLE: The validity testing principles will be applied to a hypothetical case study with a focus on the interpretation and use of scores from a translated PROM that measures health literacy (the Health Literacy Questionnaire or HLQ). DISCUSSION: Although robust psychometric properties of a PROM are a pre-condition to its use, a PROM's validity lies in the sound argument that a network of empirical evidence supports the intended interpretation and use of PROM scores for decision making in a particular context. The health sector is yet to apply contemporary theory and methodology to PROM development and validation. The theoretical and methodological processes in this paper are offered as an advancement of the theory and practice of PROM validity testing in the health sector.
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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.