Application of the optimizing health literacy and access (Ophelia) process in partnership with a refugee community in Australia: Study protocol.

Refugees experience health inequities resulting from multiple barriers and difficulties in accessing and engaging with services. A health literacy development approach can be used to understand health literacy strengths, needs, and preferences to build equitable access to services and information. This protocol details an adaptation of the Ophelia (Optimizing Health Literacy and Access) process to ensure authentic engagement of all stakeholders to generate culturally appropriate, needed, wanted and implementable multisectoral solutions among a former refugee community in Melbourne, Australia. The Health Literacy Questionnaire (HLQ), widely applied around the world in different population groups, including refugees, is usually the quantitative needs assessment tool of the Ophelia process. This protocol outlines an approach tailored to the context, literacy, and health literacy needs of former refugees. This project will engage a refugee settlement agency and a former refugee community (Karen people origin from Myanmar also formerly knowns as Burma) in codesign from inception. A needs assessment will identify health literacy strengths, needs, and preferences, basic demographic data and service engagement of the Karen community. This community will be engaged and interviewed using a semi-structured interview based on the Conversational Health Literacy and Assessment Tool (CHAT) will cover supportive professional and personal relationships, health behaviors, access to health information, use of health services, and health promotion barriers and support. Using the needs assessment data, vignettes portraying typical individuals from this community will be developed. Stakeholders will be invited to participate in ideas generation and prioritization workshops for in-depth discussion on what works well and not well for the community. Contextually and culturally appropriate and meaningful action ideas will be co-designed to respond to identified health literacy strengths, needs, and preferences of the community. This protocol will develop and test new and improved methods that are likely to be useful for community-based organizations and health services to systematically understand and improve communication, services and outcomes among disadvantaged groups, particularly migrants and refugees.

Health literacy strengths and challenges among residents of a resource-poor village in rural India: Epidemiological and cluster analyses.

Cluster analysis can complement and extend the information learned through epidemiological analysis. The aim of this study was to determine the relative merits of these two data analysis methods for describing the multidimensional health literacy strengths and challenges in a resource poor rural community in northern India. A cross-sectional survey (N = 510) using the Health Literacy Questionnaire (HLQ) was undertaken. Descriptive epidemiology included mean scores and effect sizes among sociodemographic characteristics. Cluster analysis was based on the nine HLQ scales to determine different health literacy profiles within the population. Participants reported highest mean scores for Scale 4. Social support for health (2.88) and Scale 6. Ability to actively engage with healthcare professionals (3.66). Lower scores were reported for Scale 3. Actively managing my health (1.81) and Scale 8. Ability to find good health information (2.65). Younger people (<35 years) had much higher scores than older people (ES >1.0) for social support. Eight clusters were identified. In Cluster A, educated younger men (mean age 27 years) reported higher scores on all scales except one (Scale 1. Feeling understood and supported by a healthcare professional) and were the cluster with the highest number (43%) of new hypertension diagnoses. In contrast, Cluster H also had young participants (mean age 30 years) but with low education (72% illiterate) who scored lowest across all nine scales. While epidemiological analysis provided overall health literacy scores and associations between health literacy and other characteristics, cluster analysis provided nuanced health literacy profiles with the potential to inform development of solutions tailored to the needs of specific population subgroups.

Correction: Lander et al. Health Literacy Development among People with Chronic Diseases: Advancing the State of the Art and Learning from International Practices. Int. J. Environ. Res. Public Health 2022, 19, 7315.

The authors would like to make corrections to a recently published paper [...].

Health literacy development is central to the prevention and control of non-communicable diseases.

The WHO's report Health literacy development for the prevention and control of non-communicable diseases (NCDs) delivers practical what-to-do how-to-do guidance for health literacy development to build, at scale, contextually-relevant public health actions to reduce inequity and the burden of NCDs on individuals, health systems and economies. The key premise for health literacy development is that people's health awareness and behaviours are linked to lifelong experiences and social practices, which may be multilayered, hidden and beyond their control. Meaningful community engagement, local ownership and locally driven actions are needed to identify health literacy strengths, challenges and preferences to build locally fit-for-purpose and implementable actions. Health literacy development needs to underpin local and national policy, laws and regulations to create enabling environments that reduce community exposures to NCD risk factors. Deficit approaches and siloed health system and policy responses need to be avoided, focusing instead on integrating community-based solutions through co-design, cognisant of people's daily experiences and social practices.

Digital Health Literacy as a Predictor of Awareness, Engagement, and Use of a National Web-Based Personal Health Record: Population-Based Survey Study.

BACKGROUND: Web-based personal health records (PHRs) have the potential to improve the quality, accuracy, and timeliness of health care. However, the international uptake of web-based PHRs has been slow. Populations experiencing disadvantages are less likely to use web-based PHRs, potentially widening health inequities within and among countries. OBJECTIVE: With limited understanding of the predictors of community uptake and use of web-based PHR, the aim of this study was to identify the predictors of awareness, engagement, and use of the Australian national web-based PHR, My Health Record (MyHR). METHODS: A population-based survey of adult participants residing in regional Victoria, Australia, was conducted in 2018 using telephone interviews. Logistic regression, adjusted for age, was used to assess the relationship among digital health literacy, health literacy, and demographic characteristics, and the 3 dependent variables of MyHR: awareness, engagement, and use. Digital health literacy and health literacy were measured using multidimensional tools, using all 7 scales of the eHealth Literacy Questionnaire and 4 out of the 9 scales of the Health Literacy Questionnaire. RESULTS: A total of 998 responses were analyzed. Many elements of digital health literacy were strongly associated with MyHR awareness, engagement, and use. A 1-unit increase in each of the 7 eHealth Literacy Questionnaire scales was associated with a 2- to 4-fold increase in the odds of using MyHR: using technology to process health information (odds ratio [OR] 4.14, 95% CI 2.34-7.31), understanding of health concepts and language (OR 2.25, 95% CI 1.08-4.69), ability to actively engage with digital services (OR 4.44, 95% CI 2.55-7.75), feel safe and in control (OR 2.36, 95% CI 1.43-3.88), motivated to engage with digital services (OR 4.24, 95% CI 2.36-7.61), access to digital services that work (OR 2.49, 95% CI 1.32-4.69), and digital services that suit individual needs (OR 3.48, 95% CI 1.97-6.15). The Health Literacy Questionnaire scales of health care support, actively managing health, and social support were also associated with a 1- to 2-fold increase in the odds of using MyHR. Using the internet to search for health information was another strong predictor; however, older people and those with less education were less likely to use MyHR. CONCLUSIONS: This study revealed strong and consistent patterns of association between digital health literacy and the use of a web-based PHR. The results indicate potential actions for promoting PHR uptake, including improving digital technology and skill experiences that may improve digital health literacy and willingness to engage in web-based PHR. Uptake may also be improved through more responsive digital services, strengthened health care, and better social support. A holistic approach, including targeted solutions, is needed to ensure that web-based PHR can realize its full potential to help reduce health inequities.

Modelling variance in the multidimensional Health Literacy Questionnaire: Does a General Health Literacy factor account for observed interscale correlations?

Objectives: Self-report measures of health literacy frequently encompass a group of conceptually distinct but related domains scored as either a single scale or separately for each domain. Psychometric studies of the 44-item Health Literacy Questionnaire, scored as nine separate scales, typically report the results of correlated factors confirmatory factor analyses as validity evidence. However, some scales are quite strongly correlated, raising the question of whether there is sufficient discriminant validity to warrant separate scoring. This psychometric study aims to contrast the results of fitting higher-order and bifactor models as alternative options to illuminate the issue. Methods: Correlated factors, higher-order and bifactor confirmatory factor analysis models were fitted to an Australian sample of responses to the Health Literacy Questionnaire (N = 813) using Bayesian confirmatory factor analysis methods. Results: All models representing a nine-factor structure for the Health Literacy Questionnaire fitted well. The correlated factors model replicated previous findings, showing inter-factor correlations between 0.19 and 0.93. A higher-order model showed relatively high loadings of all nine first-order factors on the second-order factor with particularly high loadings (⩾0.97) for three. Two bifactor models showed that the majority of Health Literacy Questionnaire items were multifactorial, each containing systematic variance from both a General Health Literacy factor and a domain-specific factor. Seven items from four scales were identified as strongly associated with the General Health Literacy factor, with item content suggesting that this factor indexes a broad sense of agency and efficacy in interacting with health-related information and healthcare providers. Conclusion: Contrasting correlated factors, higher-order and bifactor models fitted to the Health Literacy Questionnaire suggest that constituent items in self-report health literacy questionnaires might be anticipated to represent at least two sources of reliable and substantive common factor variance: variance associated with General Health Literacy and variance associated with a more specific domain, suggesting that items may be 'irreducibly' heterogeneous. Implications for test development and validation practice are discussed.

Health Literacy Development among People with Chronic Diseases: Advancing the State of the Art and Learning from International Practices.

Chronic diseases account for a considerable part of the strain on health care systems [...].

Use of the English Health Literacy Questionnaire (HLQ) with Health Science University Students in Nepal: A Validity Testing Study.

Research evidence shows that health literacy development is a key factor influencing non-communicable diseases care and patient outcomes. Healthcare professionals with strong health literacy skills are essential for providing quality care. We aimed to report the validation testing of the Health Literacy Questionnaire (HLQ) among health professional students in Nepal. A cross-sectional study was conducted with 419 health sciences students using the HLQ in Nepal. Validation testing and reporting were conducted using five sources outlined by 'the 2014 Standards for Educational and Psychological Testing'. The average difficulty was lowest (17.4%) for Scale 4. Social support for health, and highest (51.9%) for Scale 6. Ability to actively engage with healthcare providers. One factor Confirmatory Factor Analysis (CFA) model showed a good fit for Scale 2, Scale 7 and Scale 9 and a reasonable fit for Scale 3 and Scale 4. The restricted nine-factor CFA model showed a satisfactory level of fit. The use of HLQ is seen to be meaningful in Nepal and warrants translation into native Nepali and other dominant local languages with careful consideration of cultural appropriateness using cognitive interviews.

Reducing research wastage by starting off on the right foot: optimally framing the research question.

PURPOSE: Strongly framed research questions are clear as to the population (P), the exposures or interventions (E/I), comparison groups (C), outcomes (O), time when relevant (T), and what the investigator wants to know. A solid framework sets up the measurement model, analysis, and anticipated results. The purpose of this study was to estimate the extent to which research questions in journals that focused on patient-reported outcome measures (PROM) and quality of life (QOL) are clear. METHODS: All 440 research articles published in four PROM journals in 2020. excluding reviews, psychometric, and qualitative papers, were reviewed. Research questions were classified as: (i) adequately framed (ii) poorly framed; or (iii) unframed based on clarity criteria. Examples from each journal were presented and reframed to match results in the article. RESULTS: Of 440 articles, 195 (44.3%) were classified as adequately framed; 230 (52.2%) as poorly framed; and 15 (3.4%) as unframed. There was heterogeneity across journals (Chi-square: 20.8; 6 df; p = 0.002). Only 29% were framed according to what the investigators wanted to know; 72% were framed like a "to do" list; and 6% were framed as a research agenda. CONCLUSION: Almost half of the questions were poorly framed or unframed a practice that could contribute to research wastage. Even "adequately framed" questions rarely stated what they wanted to know a priori, increasing the risk of biased reporting. Researchers, reviewers, and editors should encourage the use established frameworks for research questions.

Codesign and implementation of an equity-promoting national health literacy programme for people living with inflammatory bowel disease (IBD): a protocol for the application of the Optimising Health Literacy and Access (Ophelia) process.

INTRODUCTION: Non-government organisations (NGOs) often represent people who are underserved or experiencing vulnerability. Crohn's & Colitis Australia (CCA) is aware that many Australians with inflammatory bowel disease (IBD) are not reached by current communication and engagement activities. The aim of the CCA IBD project is to implement the Optimising Health Literacy and Access (Ophelia) process over 3 years to collaboratively codesign ways to improve delivery of information, services and resources for people with IBD and their carers. METHODS AND ANALYSIS: Health literacy and other data for phase 1 will be collected using the Health Literacy Questionnaire, eHealth Literacy Questionnaire, IBD-related questions and qualitative interviews with people with IBD and their carers to ascertain their lived experience. Quantitative data will be analysed using descriptive statistics and cluster analysis. Identified clusters will be combined with qualitative data to develop vignettes (narratives of people's experiences of living with IBD) for stakeholder workshops to generate ideas for useful, accessible and sustainable solutions for identified health literacy needs. Selection and testing of health literacy actions happens in phase 2 and implementation and evaluation in phase 3 (2021-2023). Outcomes of this project include giving voice to people living with IBD, their carers and frontline healthcare practitioners. Genuine codesign informs the development and implementation of what is needed and wanted to improve access to and availability and quality of information and resources that support people to manage their health. There is potential for other NGOs to use the CCA Ophelia model in other health contexts to improve engagement with and understanding of the needs of the people they serve and to reduce health inequalities and improve health outcomes. ETHICS AND DISSEMINATION: Ethics approval for Ophelia phase 1 has been obtained from the Human Research Ethics Committee of Swinburne University of Technology (Ref: 20202968-4652) and by the South West Sydney Local Health District Research and Ethics Office for the purposes of questionnaire recruitment at Liverpool Hospital (Ref: 20202968-4652). Dissemination of the study findings will be the national codesign process and ownership development across the CCA community and through the genuine engagement of clinicians and relevant managers across Australia. The model and process will be directly distributed to international IBD associations and to other NGOs. It will also be disseminated through publication in a peer-reviewed journal, conference presentations and public reports on the CCA and Swinburne University of Technology website.

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.

Questionnaire validation practice within a theoretical framework: a systematic descriptive literature review of health literacy assessments.

OBJECTIVE: Validity refers to the extent to which evidence and theory support the adequacy and appropriateness of inferences based on score interpretations. The health sector is lacking a theoretically-driven framework for the development, testing and use of health assessments. This study used the Standards for Educational and Psychological Testing framework of five sources of validity evidence to assess the types of evidence reported for health literacy assessments, and to identify studies that referred to a theoretical validity testing framework. METHODS: A systematic descriptive literature review investigated methods and results in health literacy assessment development, application and validity testing studies. Electronic searches were conducted in EBSCOhost, Embase, Open Access Theses and Dissertations and ProQuest Dissertations. Data were coded to the Standards' five sources of validity evidence, and for reference to a validity testing framework. RESULTS: Coding on 46 studies resulted in 195 instances of validity evidence across the five sources. Only nine studies directly or indirectly referenced a validity testing framework. Evidence based on relations to other variables is most frequently reported. CONCLUSIONS: The health and health equity of individuals and populations are increasingly dependent on decisions based on data collected through health assessments. An evidence-based theoretical framework provides structure and coherence to existing evidence and stipulates where further evidence is required to evaluate the extent to which data are valid for an intended purpose. This review demonstrates the use of the Standards' theoretical validity testing framework to evaluate sources of evidence reported for health literacy assessments. Findings indicate that theoretical validity testing frameworks are rarely used to collate and evaluate evidence in validation practice for health literacy assessments. Use of the Standards' theoretical validity testing framework would improve evaluation of the evidence for inferences derived from health assessment data on which public health and health equity decisions are based.

Translation method is validity evidence for construct equivalence: analysis of secondary data routinely collected during translations of the Health Literacy Questionnaire (HLQ).

BACKGROUND: Cross-cultural research with patient-reported outcomes measures (PROMs) assumes that the PROM in the target language will measure the same construct in the same way as the PROM in the source language. Yet translation methods are rarely used to qualitatively maximise construct equivalence or to describe the intents of each item to support common understanding within translation teams. This study aimed to systematically investigate the utility of the Translation Integrity Procedure (TIP), in particular the use of item intent descriptions, to maximise construct equivalence during the translation process, and to demonstrate how documented data from the TIP contributes evidence to a validity argument for construct equivalence between translated and source language PROMs. METHODS: Analysis of secondary data was conducted on routinely collected data in TIP Management Grids of translations (n = 9) of the Health Literacy Questionnaire (HLQ) that took place between August 2014 and August 2015: Arabic, Czech, French (Canada), French (France), Hindi, Indonesian, Slovak, Somali and Spanish (Argentina). Two researchers initially independently deductively coded the data to nine common types of translation errors. Round two of coding included an identified 10th code. Coded data were compared for discrepancies, and checked when needed with a third researcher for final code allocation. RESULTS: Across the nine translations, 259 changes were made to provisional forward translations and were coded into 10 types of errors. Most frequently coded errors were Complex word or phrase (n = 99), Semantic (n = 54) and Grammar (n = 27). Errors coded least frequently were Cultural errors (n = 7) and Printed errors (n = 5). CONCLUSIONS: To advance PROM validation practice, this study investigated a documented translation method that includes the careful specification of descriptions of item intents. Assumptions that translated PROMs have construct equivalence between linguistic contexts can be incorrect due to errors in translation. Of particular concern was the use of high level complex words by translators, which, if undetected, could cause flawed interpretation of data from people with low literacy. Item intent descriptions can support translations to maximise construct equivalence, and documented translation data can contribute evidence to justify score interpretation and use of translated PROMS in new linguistic contexts.

Using the Health Literacy Questionnaire (HLQ) with Providers in the Early Intervention Setting: A Qualitative Validity Testing Study.

More than one in four parents in the United States of America (USA) have low health literacy, which is associated with reduced health equity and negatively impacts child health outcomes. Early intervention (EI) programs are optimally placed to build the health literacy capacity of caregivers, which could improve health equity. The health literacy of interdisciplinary EI providers has not previously been measured. This study used the Health Literacy Questionnaire (HLQ) with EI providers (n = 10) to investigate evidence based on response (cognitive) processes. Narratives from cognitive interviews gave reasons for HLQ score choices, and concordance and discordance between HLQ item intent descriptions and narrative data were assessed using thematic analysis. Results found scales with highest concordance for Scales 3, 6, and 9 (each 96%, n = 24). Concordance was lowest on Scale 5 (88%, n = 22), although still strong with only 12% discordance. Three themes reflecting discordance were identified: (1) Differences between Australian and USA culture/health systems; (2) Healthcare provider perspective; and (3) Participants with no health problems to manage. Results show strong concordance between EI providers' narrative responses and item intents. Study results contribute validity evidence for the use of HLQ data to inform interventions that build health literacy capacity of EI providers to then empower and build the health literacy of EI parents.

Health Literacy is Associated with Health Behaviors in Students from Vocational Education and Training Schools: A Danish Population-Based Survey.

Health literacy has been identified as an important and changeable intermediary determinant of health equity. Vocational education and training (VET) schools are a relevant setting for health behavior interventions seeking to diminish health inequities because many VET students come from low socio-economic status backgrounds. This study examines VET students' health literacy and its association with health behavior based on a cross-sectional survey among 6119 students from 58 VET schools in Denmark in 2019. Two scales from the Health Literacy Questionnaire was used to assess domains of health literacy. Data were analyzed using Anova and logistic regression. The study population consisted of 43.4% female, and mean age was 24.2 years (range 15.8-64.0). The health literacy domain 'Actively managing my health' mean was 2.51, SD 0.66, and 'Appraisal of health information' mean was 2.37, SD 0.65. For both domains, being female, older age, attending the VET educational program Care-health-pedagogy, and higher self-rated health were associated with higher scale scores. In the adjusted analyses, lower scale scores were associated with less frequent breakfast, daily smoking, high-risk alcohol behavior and moderate-to-low physical activity. Our results show that low health literacy is associated with unhealthy behaviors in this population. Our results support and inform health literacy research and practice in educational institutions and services.

Questionnaire validation practice: a protocol for a systematic descriptive literature review of health literacy assessments.

INTRODUCTION: Contemporary validity testing theory holds that validity lies in the extent to which a proposed interpretation and use of test scores is justified, the evidence for which is dependent on both quantitative and qualitative research methods. Despite this, we hypothesise that development and validation studies for assessments in the field of health primarily report a limited range of statistical properties, and that a systematic theoretical framework for validity testing is rarely applied. Using health literacy assessments as an exemplar, this paper outlines a protocol for a systematic descriptive literature review about types of validity evidence being reported and if the evidence is reported within a theoretical framework. METHODS AND ANALYSIS: A systematic descriptive literature review of qualitative and quantitative research will be used to investigate the scope of validation practice in the rapidly growing field of health literacy assessment. This review method employs a frequency analysis to reveal potentially interpretable patterns of phenomena in a research area; in this study, patterns in types of validity evidence reported, as assessed against the criteria of the 2014 Standards for Educational and Psychological Testing, and in the number of studies using a theoretical validity testing framework. The search process will be consistent with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Outcomes of the review will describe patterns in reported validity evidence, methods used to generate the evidence and theoretical frameworks underpinning validation practice and claims. This review will inform a theoretical basis for future development and validity testing of health assessments in general. ETHICS AND DISSEMINATION: Ethics approval is not required for this systematic review because only published research will be examined. Dissemination of the review findings will be through publication in a peer-reviewed journal, at conference presentations and in the lead author's doctoral thesis.

Barriers to Breast Cancer Screening among Diverse Cultural Groups in Melbourne, Australia.

This study explored the association between health literacy, barriers to breast cancer screening, and breast screening participation for women from culturally and linguistically diverse (CALD) backgrounds. English-, Arabic- and Italian-speaking women (n = 317) between the ages of 50 to 74 in North West Melbourne, Australia were recruited to complete a survey exploring health literacy, barriers to breast cancer screening, and self-reported screening participation. A total of 219 women (69%) reported having a breast screen within the past two years. Results revealed that health literacy was not associated with screening participation. Instead, emotional barriers were a significant factor in the self-reported uptake of screening. Three health literacy domains were related to lower emotional breast screening barriers, feeling understood and supported by healthcare providers, social support for health and understanding health information well enough to know what to do. Compared with English- and Italian-speaking women, Arabic-speaking women reported more emotional barriers to screening and greater challenges in understanding health information well enough to know what to do. Interventions that can improve breast screening participation rates should aim to reduce emotional barriers to breast screening, particularly for Arabic-speaking women.

Conceptualisation and development of the Conversational Health Literacy Assessment Tool (CHAT).

BACKGROUND: The aim of this study was to develop a tool to support health workers' ability to identify patients' multidimensional health literacy strengths and challenges. The tool was intended to be suitable for administration in healthcare settings where health workers must identify health literacy priorities as the basis for person-centred care. METHODS: Development was based on a qualitative co-design process that used the Health Literacy Questionnaire (HLQ) as a framework to generate questions. Health workers were recruited to participate in an online consultation, a workshop, and two rounds of pilot testing. RESULTS: Participating health workers identified and refined ten questions that target five areas of assessment: supportive professional relationships, supportive personal relationships, health information access and comprehension, current health behaviours, and health promotion barriers and support. CONCLUSIONS: Preliminary evidence suggests that application of the Conversational Health Literacy Assessment Tool (CHAT) can support health workers to better understand the health literacy challenges and supportive resources of their patients. As an integrated clinical process, the CHAT can supplement existing intake and assessment procedures across healthcare settings to give insight into patients' circumstances so that decisions about care can be tailored to be more appropriate and effective.

Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity.

BACKGROUND: Data 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. OBJECTIVE: This 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.