Measuring health literacy to inform actions to address health inequities: a cluster analysis approach based on the Australian national health literacy survey.

BACKGROUND: Measuring health literacy can inform interventions to address health inequities. This study used cluster analysis to examine health literacy data to determine if it can provide more insightful information than standard descriptive analysis to better inform intervention development. METHODS: Using data from the Australian National Health Survey (2018), this study compared descriptive analysis and cluster analysis results of two states-New South Wales (NSW) and Victoria-generated from the Health Literacy Questionnaire (HLQ). Based on the nine scale scores of the HLQ, a hierarchical cluster analysis using Ward's method for linkage was undertaken. RESULTS: The number of NSW and Victoria respondents was 1018 and 923, respectively. The nine HLQ scale full sample mean scores from both states were similar. However, the cluster analyses identified 11 clusters for NSW and 12 clusters for Victoria. While six clusters from each state presented similar health literacy patterns, five and six clusters from NSW and Victoria, respectively, displayed unique health literacy patterns. CONCLUSIONS: The results demonstrate that descriptive analysis only provides an overview and may lead to one-size-fits-all interventions. The varying health literacy patterns among subgroups resulting from the cluster analysis pave the way to inform tailored actions to improve health equity.

Outcomes of co-designed communities of practice that support members to address public health issues.

Communities of practice are commonly used to support members in responding to public health issues. This study evaluated the outcomes of five co-designed communities of practice to determine if members' expectations were met, if knowledge sharing between members extended to knowledge translation, and if that supported members in addressing public health issues. Data were collected through an initial needs assessment, observations were made during community of practice sessions over 1 year, and qualitative interviews were conducted at the end of that year. The findings provided evidence that members' expectations were met, knowledge sharing took place within the communities of practice, and personal benefits gained supported members in advancing knowledge sharing with other members to knowledge translation outside their community of practice. Results demonstrate three outcomes of knowledge translation for members: disseminating knowledge to others, applying knowledge to make small-scale changes in practice and leveraging the knowledge to expand its reach beyond members' organizations. While the scale and speed of expanding outcomes were below initial expectations as indicated in the initial needs assessments, members remained optimistic about achieving larger-scale impacts in the future. This study showed that communities of practice achieve gradual progress rather than quick wins. Co-design supports the facilitators in meeting members' needs, which can positively contribute to members sharing knowledge and translating that knowledge to support their practice to address public health issues.

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.

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.

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.

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.

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.

The Health Literacy Questionnaire (HLQ) at the patient-clinician interface: a qualitative study of what patients and clinicians mean by their HLQ scores.

BACKGROUND: The Health Literacy Questionnaire (HLQ) has nine scales that each measure an aspect of the multidimensional construct of health literacy. All scales have good psychometric properties. However, it is the interpretations of data within contexts that must be proven valid, not just the psychometric properties of a measurement instrument. The purpose of this study was to establish the extent of concordance and discordance between individual patient and clinician interpretations of HLQ data in the context of complex case management. METHODS: Sixteen patients with complex needs completed the HLQ and were interviewed to discuss the reasons for their answers. Also, the clinicians of each of these patients completed the HLQ about their patient, and were interviewed to discuss the reasons for their answers. Thematic analysis of HLQ scores and interview data determined the extent of concordance between patient and clinician HLQ responses, and the reasons for discordance. RESULTS: Highest concordance (80%) between patient and clinician item-response pairs was seen in Scale 1 and highest discordance (56%) was seen in Scale 6. Four themes were identified to explain discordance: 1) Technical or literal meaning of specific words; 2) Patients' changing or evolving circumstances; 3) Different expectations and criteria for assigning HLQ scores; and 4) Different perspectives about a patient's reliance on healthcare providers. CONCLUSION: This study shows that the HLQ can act as an adjunct to clinical practice to help clinicians understand a patient's health literacy challenges and strengths early in a clinical encounter. Importantly, clinicians can use the HLQ to detect differences between their own perspectives about a patient's health literacy and the patient's perspective, and to initiate discussion to explore this. Provision of training to better detect these differences may assist clinicians to provide improved care. The outcomes of this study contribute to the growing body of international validation evidence about the use of the HLQ in different contexts. More specifically, this study has shown that the HLQ has measurement veracity at the patient and clinician level and may support clinicians to understand patients' health literacy and enable a deeper engagement with healthcare services.

Distribution of health literacy strengths and weaknesses across socio-demographic groups: a cross-sectional survey using the Health Literacy Questionnaire (HLQ).

BACKGROUND: Recent advances in the measurement of health literacy allow description of a broad range of personal and social dimensions of the concept. Identifying differences in patterns of health literacy between population sub-groups will increase understanding of how health literacy contributes to health inequities and inform intervention development. The aim of this study was to use a multi-dimensional measurement tool to describe the health literacy of adults in urban and rural Victoria, Australia. METHODS: Data were collected from clients (n = 813) of 8 health and community care organisations, using the Health Literacy Questionnaire (HLQ). Demographic and health service data were also collected. Data were analysed using descriptive statistics. Effect sizes (ES) for standardised differences in means were used to describe the magnitude of difference between demographic sub-groups. RESULTS: Mean age of respondents was 72.1 (range 19-99) years. Females comprised 63% of the sample, 48% had not completed secondary education, and 96% reported at least one existing health condition. Small to large ES were seen for mean differences in HLQ scales between most demographic groups. Compared with participants who spoke English at home, those not speaking English at home had much lower scores for most HLQ scales including the scales 'Understanding health information well enough to know what to do' (ES -1.09 [95% confidence interval (CI) -1.33 to -0.84]), 'Ability to actively engage with healthcare providers' (ES -1.00 [95% CI -1.24, -0.75]), and 'Navigating the healthcare system' (ES -0.72 [95% CI -0.97, -0.48]). Similar patterns and ES were seen for participants born overseas compared with those born in Australia. Smaller ES were seen for sex, age group, private health insurance status, number of chronic conditions, and living alone. CONCLUSIONS: This study has revealed some large health literacy differences across nine domains of health literacy in adults using health services in Victoria. These findings provide insights into the relationship between health literacy and socioeconomic position in vulnerable groups and, given the focus of the HLQ, provide guidance for the development of equitable interventions.

The grounded psychometric development and initial validation of the Health Literacy Questionnaire (HLQ).

BACKGROUND: Health literacy has become an increasingly important concept in public health. We sought to develop a comprehensive measure of health literacy capable of diagnosing health literacy needs across individuals and organisations by utilizing perspectives from the general population, patients, practitioners and policymakers. METHODS: Using a validity-driven approach we undertook grounded consultations (workshops and interviews) to identify broad conceptually distinct domains. Questionnaire items were developed directly from the consultation data following a strict process aiming to capture the full range of experiences of people currently engaged in healthcare through to people in the general population. Psychometric analyses included confirmatory factor analysis (CFA) and item response theory. Cognitive interviews were used to ensure questions were understood as intended. Items were initially tested in a calibration sample from community health, home care and hospital settings (N=634) and then in a replication sample (N=405) comprising recent emergency department attendees. RESULTS: Initially 91 items were generated across 6 scales with agree/disagree response options and 5 scales with difficulty in undertaking tasks response options. Cognitive testing revealed that most items were well understood and only some minor re-wording was required. Psychometric testing of the calibration sample identified 34 poorly performing or conceptually redundant items and they were removed resulting in 10 scales. These were then tested in a replication sample and refined to yield 9 final scales comprising 44 items. A 9-factor CFA model was fitted to these items with no cross-loadings or correlated residuals allowed. Given the very restricted nature of the model, the fit was quite satisfactory: χ²WLSMV(866 d.f.) = 2927, p<0.000, CFI = 0.936, TLI = 0.930, RMSEA = 0.076, and WRMR = 1.698. Final scales included: Feeling understood and supported by healthcare providers; Having sufficient information to manage my health; Actively managing my health; Social support for health; Appraisal of health information; Ability to actively engage with healthcare providers; Navigating the healthcare system; Ability to find good health information; and Understand health information well enough to know what to do. CONCLUSIONS: The HLQ covers 9 conceptually distinct areas of health literacy to assess the needs and challenges of a wide range of people and organisations. Given the validity-driven approach, the HLQ is likely to be useful in surveys, intervention evaluation, and studies of the needs and capabilities of individuals.

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 [...].

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.

Presenting evidence-based health information for people with multiple sclerosis: the IN-DEEP project protocol.

BACKGROUND: Increasingly, evidence-based health information, in particular evidence from systematic reviews, is being made available to lay audiences, in addition to health professionals. Research efforts have focused on different formats for the lay presentation of health information. However, there is a paucity of data on how patients integrate evidence-based health information with other factors such as their preferences for information and experiences with information-seeking. The aim of this project is to explore how people with multiple sclerosis (MS) integrate health information with their needs, experiences, preferences and values and how these factors can be incorporated into an online resource of evidence-based health information provision for people with MS and their families. METHODS: This project is an Australian-Italian collaboration between researchers, MS societies and people with MS. Using a four-stage mixed methods design, a model will be developed for presenting evidence-based health information on the Internet for people with MS and their families. This evidence-based health information will draw upon systematic reviews of MS interventions from The Cochrane Library. Each stage of the project will build on the last. After conducting focus groups with people with MS and their family members (Stage 1), we will develop a model for summarising and presenting Cochrane MS reviews that is integrated with supporting information to aid understanding and decision making. This will be reviewed and finalised with people with MS, family members, health professionals and MS Society staff (Stage 2), before being uploaded to the Internet and evaluated (Stages 3 and 4). DISCUSSION: This project aims to produce accessible and meaningful evidence-based health information about MS for use in the varied decision making and management situations people encounter in everyday life. It is expected that the findings will be relevant to broader efforts to provide evidence-based health information for patients and the general public. The international collaboration also permits exploration of cultural differences that could inform international practice.

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 [...].

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.

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.

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.

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.