Development and validation of a health literacy scale for family caregivers of older people with chronic illness.

BACKGROUND: Family caregivers (FCs) encounter a variety of health problems in older people with chronic illness, necessitating a certain level of health literacy to access, understand, appraise and apply health information and services. This study aimed to develop and validate a scale for measuring health literacy among FCs of older people with chronic illness. METHODS: Concept mapping was first employed to develop a conceptual model of health literacy of FCs. Scale domains were derived from the conceptual model, and item generation was performed using deductive and inductive methods. Quantitative methods, including merging scale dimensions and items, expert reviews, cognitive interviews, and item reduction analysis, were used to refine the scale. Confirmatory factor analysis was employed to validate the scale's structure. Concurrent validity, internal consistency, and test-retest reliability were also examined. RESULTS: A 20-dimension conceptual model was developed, and 60 items were generated for the scale. Expert review (content validity index > 0.85) and cognitive interview with FCs confirmed the relevance and clarity of the majority of the generated scale items. Confirmatory factor analysis with 451 FCs of older people with chronic illness supported a 5-factor structure (symptom management, daily personal care and household tasks, care coordination, communication and relationship with the care recipient, and self-care of caregivers) with 42 finalized scale items, including four levels of health literacy skills (accessing, understanding, appraising and applying health information). Concurrent validity with the European Health Literacy Questionnaire (HLS-EU-Q47) was satisfactory (r = 0.67, p < 0.01). The Cronbach's α coefficient of the scale was 0.96, with subscales ranging from 0.84 to 0.91. The two-week test-retest reliability was 0.77 (p < 0.01). CONCLUSION: This study developed a conceptual model explaining the concept and factors of health literacy among FCs of older people with chronic illness that could provide the groundwork for future studies in developing relevant evidence-based interventions. A new Health Literacy Scale-Family Caregiver (HLS-FC) with satisfactory psychometric properties was developed in this study, which can be utilized to identify caregivers with insufficient health literacy and facilitate timely interventions by healthcare professionals.

Development and validation of the Communal and Agentic Workplace Climate Scale.

OBJECTIVES: This study aims to define and assess communal and agentic workplace climates (AWC), 2 pivotal dimensions perceived by employees within organizational contexts. Communal workplace climate highlights employees' well-being, while AWC emphasizes productivity-related aspects. MATERIAL AND METHODS: To enhance comprehension, the Communal and Agentic Workplace Climate Scale (CAWCS) was created and validated through a series of studies. The research involved 4008 employees from diverse positions and organizations across Poland. Initially, a pool of 20 items was designed to reflect these dimensions, with exploratory factor analysis identifying a robust set of 12 items. RESULTS: Confirmatory factor analysis substantiated the 2-factor structure of CAWCS. Reliability analyses indicated good internal consistency, supported by correlation analyses linking scale scores with diverse attitudinal and behavioral constructs. CONCLUSIONS: This validation confirms the validity of CAWCS and highlights the significant associations between employees' perceptions of these dimensions and their workplace experiences and behaviors. Int J Occup Med Environ Health. 2024;37(3).

Core items selection and psychometric properties of the adult attention-deficit hyperactivity disorder self-report scale-chinese short version (ASRS-CSV).

OBJECTIVE: This study aimed to develop and validate the Chinese Short Version of the Adult ADHD Self-Report Scale (ASRS-CSV), addressing the need for culturally appropriate diagnostic tools for Attention-Deficit Hyperactivity Disorder (ADHD) in the Chinese adult population. METHODS: Utilizing a combination of intergroup difference analysis, factor analysis, and network analysis, we identified core ADHD symptoms pertinent to the Chinese cultural context. The study involved two samples: a vocational and technical school sample (N=1144) and an internet sample (N=1654), comprising adults aged 16-25 years. Reliability, validity, and diagnostic efficacy of the ASRS-CSV were assessed through psychometric testing. RESULTS: The ASRS-CSV demonstrated high internal consistency (Cronbach's alpha > 0.9) and robust convergent validity (AVE > 0.7). The scale's diagnostic cutoff points were optimized, revealing high sensitivity and specificity for ADHD screening. Cross-cultural analysis highlighted differences in core ADHD symptoms between Chinese and Western populations, underscoring the scale's cultural sensitivity. CONCLUSION: The ASRS-CSV is a reliable, valid, and efficient tool for screening ADHD in Chinese adults, reflecting the socio-cultural nuances of ADHD symptomatology. Its development marks a significant advancement in the field of psychiatry, offering a tailored approach for ADHD assessment in China and contributing to the global discourse on cross-cultural psychiatric diagnosis.

Psychometric Features of the Arabic Version of the Children's Communication Checklist (CCC2).

Background: The Children's Communication Checklist-Second Edition (CCC-2) uniquely assesses overlooked communication elements such as pragmatics and context use, which are rarely addressed by conventional language assessments. This study focuses on the psychometric assessment of the CCC-2's Arabic version, tailored to evaluate communication challenges in Arabic-speaking children. Aim: This study aims to validate the Arabic version of CCC-2 by testing its reliability and validity specifically for three higher-order constructs: Specific Language Impairment (SLI), Social Communication Disorder (SCD), and Impaired Behaviour within the Arabic-speaking population. Methods: A total of 121 participants in Saudi Arabia, showcasing diverse age and gender distributions, participated in the validation process. The study employed a Reflective-Reflective Higher-Order Construct (R-R HOC) model using partial least squares-structural equation modeling (PLS-SEM) to ensure content validity and cross-cultural adaptation of the translated items. Metrics such as Cronbach's alpha for reliability and Average Variance Extracted (AVE) for convergent validity were specifically examined. Results: The study confirmed the reliability and validity of the Arabic CCC-2, demonstrating robust psychometric properties, with Cronbach's alpha and AVE scores indicating satisfactory reliability and convergent validity across constructs. Structural model evaluation further supported the strong interrelations among the constructs of SLI, SCD, and Impaired Behaviour. Conclusion: The results substantiate the Arabic CCC-2 as a reliable and valid tool for assessing communication challenges in Arabic-speaking children, particularly for diagnosing SLI, SCD, and Impaired Behaviour. Implications: The validated Arabic CCC-2 has significant potential for application in clinical and educational settings and suggests directions for future research to explore its utility further in diverse clinical populations.

Evaluation of chronic stress status and quality of life in cats suffering from chronic kidney disease and suspected feline infectious peritonitis based on hair cortisol concentration analysis and a questionnaire.

Hair cortisol concentration (HCC) and a questionnaire were used as indicators of chronic stress status and quality of life (QoL), respectively, in cats. To date, there has been limited research on the simultaneous application of both indicators in unwell cats. Our aim was to evaluate HCC and questionnaire data obtained from a healthy cat cohort (n = 61) and cat cohorts with either chronic kidney disease (CKD) (n = 78) or suspected feline infectious peritonitis (FIP) (n = 24). Furthermore, we also investigated the correlation between HCC and clinical pathological data. For this study, hair from the abdomen of cats was collected and analyzed for HCC using a commercial ELISA kit. Owners also completed a questionnaire, from which average-item-weighted-impact-scores (AWISs) were calculated. Cats with late-stage-CKD (median, HCC = 330.15 pg/mg, AWIS = -0.43) presented with a significantly higher HCC (p < 0.01) and a significantly lower AWIS (p < 0.01) than cats with early-stage-CKD (HCC = 183.56 pg/mg, AWIS = 1.08). Similarly, there were significant differences in both HCC (p < 0.001) and AWIS (p < 0.001) between cats with suspected FIP (HCC = 896.27 pg/mg, AWIS = -1.97) and healthy cats (HCC = 181.24 pg/mg, AWIS = 1.24). The degree of consistency between the HCC results and the questionnaire results reminds us that the severity of a chronic disease or the presence of a life-threatening disease can significantly increase stress and thus can affect the QoL of cats.

Translation, cross-cultural adaptation, and psychometric validation of the Malay version of the Assessment of Quality of Life-6 Dimensions (Malay-AQoL-6D) instrument among Malaysians living with chronic heart failure.

BACKGROUND: This study aimed to translate and culturally adapt the Assessment of Quality of Life (AQoL)-6D into Malay (Malay-AQoL-6D), and assesses the instrument's acceptability, reliability, and validity among Malaysians living with chronic heart failure (HF). METHODS: The translation and cross-cultural adaptation process adhered to international guidelines. The Malay-AQoL-6D underwent content and face validity assessments via expert review, and pretesting among healthy individuals and patients with chronic conditions. Subsequent psychometric validation utilised clinico-sociodemographic data and paired AQoL-6D and EQ-5D-5L data from a health-related quality-of-life (HRQoL) survey involving Malay-speaking patients with HF, which encompassed assessments of Malay-AQoL-6D acceptability, internal consistency and test-retest reliability, as well as its construct, concurrent, convergent and divergent, and known-group validity. RESULTS: The Malay-AQoL-6D was deemed acceptable among clinicians and local patients, achieving a 90.8% completion rate among 314 patients surveyed. The instrument demonstrated strong content validity (item-level content validity index [CVI]: 0.83-1.00, average CVI: 0.98), internal consistency (Cronbach's alpha: 0.72-0.89; MacDonald's omega: 0.82-0.90, excluding the Senses dimension), and test-retest reliability (average intraclass correlation coefficients: 0.79-0.95). Confirmatory factor analysis confirmed the instrument's two-level, six-factor structure (Satorra-Bentler [SB]-scaled χ2(df: 164): 283.67, p-value < 0.001; root mean square error of approximation [RMSEA]: 0.051; comparative fix index [CFI]: 0.945, Tucker-Lewis index [TLI]: 0.937; standardised root mean-squared error [SRMR]: 0.058). The Malay-AQoL-6D's concurrent validity was evident through its good agreement with EQ-5D-5L. Multiple hypothesis tests further affirmed its construct and known-group validity. The Malay-AQoL-6D's psychometric properties remained consistent across different missing data techniques. CONCLUSION: The findings suggest that Malay-AQoL-6D could be a culturally acceptable, reliable, and valid HRQoL measure for quantifying HRQoL among the local HF population. Future studies are necessary to further validate the instrument against other measures and confirm the instrument's test-retest reliability and responsiveness, which are possible with the availability of the Malay-AQoL-6D.

Psychometric validation of the Persian version of the ethical awareness scale for nurses working in Iranian intensive care units.

AIM: The purpose of this study was to translate and validate the ethical awareness scale for nurses working in Iranian intensive care units. DESIGN: A cross-sectional psychometric study. METHODS: The study was conducted in Oct 2020 to Sep 2021, involving the participation of 200 ICU nurses. The process included translation of the original version of the ethical awareness scale into Persian, following the World Health Organization guideline, for use in Iran. The translated version was then evaluated for reliability, face validity, content validity ratio, content validity index, convergent validity and construct validity. RESULTS: The initial reliability of the scale was established. In qualitative face validity, a few items changed slightly and all items were retained in the quantitative face validity assessment. Based on Lawshe's values, three items were removed from the scale during CVR assessment. All items exhibited acceptable CVI scores. Convergent validity was established with an average variance extracted greater than 0.5. The fit indices, such as CFI = 0.94, GFI = 0.94, RMSEA = 0.01, AGFI = 0.97 and CMIN/DF = 2.99, supported the structural model of the scale. The fit indices for the structural model of the scale were all within acceptable ranges, suggesting that the model fit the data well. Its reliability was confirmed through the test-retest method, with Cronbach's alpha = 0.84 and McDonald's omega coefficient >0.8. CONCLUSION: The findings of this study indicate the Persian version of the ethical awareness scale for Iran (EAS-IR) is comparable in content to the original version, demonstrating its validity and reliability for assessing ethical awareness among Iranian nurses in ICUs. The scale can be a valuable resource for measuring ethical awareness in the Iranian healthcare context and may contribute to improving ethical practices and decision-making in ICU settings. PATIENT OR PUBLIC CONTRIBUTION: In this project, no patient or public contribution was necessary, because it was not applied to our work.

Cross-cultural adaptation and psychometric validation of the french version of the "defense and veterans pain rating scale" for acute and chronic pain: A prospective clinical study.

BACKGROUND: Pain assessment and proper evaluation of pain is a prerequisite for treatment of acute and chronic pain. Until now, most evaluations use only resting pain intensity and a unidimensional scale, although multidimensional pain assessment and especially assessment of functional pain impact on activities is recommended. The "Defense and Veterans Pain Rating Scale" (DVPRS) permits this multidimensional assessment, but no validated French translation exists. OBJECTIVES: To validate the French translation of the multidimensional DVPRS, called Functional Pain Scale (FPS) in multiple settings of acute and chronic pain. STUDY DESIGN: Prospective observational study. SETTING: Two large hospitals in the French-speaking region of Switzerland. METHODS: We recruited 232 patients from February 2022 to January 2023. Patients with acute or chronic pain in different settings received a paper questionnaire with both the NRS and the Functional Pain Scale and a customized evaluation questionnaire. Correlation of FPS and NRS, psychometric properties and patient preferences were analysed. RESULTS: For the whole group of 232 patients, correlation of FPS and NRS was high, as well for all subgroups. The multi-item FPS scale showed excellent internal consistency. A large majority of patients, even those >75 years old, preferred FPS over NRS and stated that the FPS was easy to use. CONCLUSIONS: The study confirms that the French translation of the DVPRS (= Functional Pain Scale) is a valid measurement instrument for acute and chronic pain evaluation in a wide range of patient groups, and easy to use by patients.

Psychometric evaluation of the patient-reported experience of cognitive impairment in schizophrenia (PRECIS) scale.

BACKGROUND: Cognitive impairment associated with schizophrenia (CIAS) represents a distinct, persistent, and core group of schizophrenia symptoms. Cognitive symptoms have been shown to have an impact on quality of life. There are several published CIAS measures, but none based on direct patient self-report. It is important to capture the patient's perspective to supplement performancebased outcome measures of cognition to provide a complete picture of the patient's experience. This paper describes additional validation work on the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument. METHODS: Data from two large, international, pharmaceutical clinical trials in medically and psychiatrically stable English-speaking patients with schizophrenia and 88 healthy controls were analyzed. An exploratory factor analysis (EFA) was conducted in one trial (n = 215), using the original 35-item PRECIS. The factor structure suggested by EFA was further evaluated using item response theory (IRT; Samejima's graded response model), and tested using confirmatory factor analysis (CFA). Both EFA and CFA results were tested in a second trial with similar inclusion/exclusion characteristics (n = 410). Additional statistical properties were evaluated in healthy controls. RESULTS: EFA suggested that the best solution after item reduction suggested a factor structure of 6 factors based on 26 items (memory, communication, self-control, executive function, attention, sharpness of thought), supporting a total score, with an additional 2-item bother score (28 items in all). IRT analysis indicated the items were well-ordered within each domain. The CFA demonstrated excellent model fit, accounting for 69% of the variance. The statistical properties of the 28-item version of the PRECIS were confirmed in the second trial. Evidence for internal consistency and test-retest reliability was robust. Known-groups validity was supported by comparison of healthy controls with patients with schizophrenia. Correlations indicated moderate associations between PRECIS and functioning instruments like the Schizophrenia Cognition Rating Scale (SCoRS), but weak correlations with performance-based outcomes like MATRICS Consensus Cognitive Battery (MCCB). DISCUSSION: Using two clinical trial samples, we identified a robust factor structure for the PRECIS and were able to replicate it in the second sample. Evaluation of the meaningful score difference (MSD) should be repeated in future studies, as these samples did not show enough change for it to be evaluated. CONCLUSIONS: This analysis provides strong evidence for the reliability and validity of the PRECIS, a 28-item, patient-reported instrument to assess cognitive impairment associated with schizophrenia. The correlation with functioning and the weak correlation with performance on cognitive tasks suggests that patient reports of cognitive impairment measure a unique aspect of patient experience.

Translation, cultural adaptation, and validation of Numerical Pain Rating Scale and Global Rating of Change in Tibetan musculoskeletal trauma patients.

Tibetan-speaking patients seeking care in predominantly Mandarin-speaking healthcare settings frequently face communication barriers, leading to potential disparities and difficulties in accessing care. To address this issue, we translated, culturally adapted, and validated the Numerical Pain Rating Scale (NPRS) and the Global Rating of Change (GRoC) into Tibetan (NPRS-Tib and GRoC-Tib), aiming to facilitate cross-linguistic and cross-cultural interactions while examining potential challenges in the adaptation process. Using standard translation-backward translation methods, expert review, pilot testing, and validation through a cross-sectional study with a short-term longitudinal component, we engaged 100 Tibetan patients with musculoskeletal trauma for psychometric validation, including 37 women (aged 22-60 years, mean age 39.1 years). The NPRS-Tib and GRoC-Tib exhibited outstanding psychometric properties, with an Intraclass Correlation Coefficient (ICC) of 0.983 for NPRS-Tib indicating superb test-retest reliability, and expert review confirming good content validity for both instruments. A Spearman's correlation coefficient (Rho) of -0.261 (P = 0.0087) revealed a significant, albeit weak, correlation between changes in NPRS-Tib scores and GRoC-Tib scores. The adaptation process also presented notable challenges, including translation discrepancies from translators' diverse backgrounds and levels of expertise, ambiguity in scale options, and the lack of established tools for criterion validity assessment in Tibetan.

Systematic review of memory assessment in virtual reality: evaluating convergent and divergent validity with traditional neuropsychological measures.

Introduction: The evaluation of memory is a crucial aspect of both cognitive research and clinical applications, as it offers valuable insights into an individual's cognitive wellbeing and performance. Conventional neuropsychological assessments represent the established method for assessing different aspects of memory. Recent technological advancements, specifically in the field of virtual reality (VR), have introduced novel methods for evaluating memory. Objective: This systematic review aims to examine the current state of memory assessment using VR technologies, assessing the degree of convergence and divergence between VR-based memory assessments and conventional neuropsychological tests. Method: A systematic review of the literature was conducted searching PubMed, PsycINFO, Web of Science databases, leading to the incorporation of 24 studies. Studies were grouped according to the examined memory domain (episodic, prospective, spatial domain). Convergence and divergence validity were examined for each, and information on software and hardware features was collected. Results: This review demonstrates a notable alignment between VR-based memory assessments and conventional neuropsychological tests. Moreover, VR tasks have shown to exhibit associations with executive functions and overall cognitive performance. The inclusion of various ecological contexts, such as residential environments, commercial establishments, and simulated scenarios, serves to augment the ecological validity of memory evaluations conducted in VR. Discussion: The findings indicate that VR assessments demonstrate a functional perspective by effectively capturing the dynamic relationship between memory, executive functions, and overall cognitive performance. Nevertheless, it is imperative to acknowledge and tackle certain constraints that may hinder the widespread adoption and utilization of VR tasks. These limitations encompass factors such as restricted accessibility to VR tasks and the presence of heterogeneity in VR hardware and software. The dynamic and ever-changing nature of VR technology presents a range of potential avenues for future investigation and utilization in the domain of memory evaluation.

Development and Empirical Test of the Research-Informed South African Relationship Functioning Assessment (SARFA).

Intimate partners play an important role in chronic diseases. Despite the chronic disease burden increase in sub-Saharan Africa, very few culturally-relevant quantitative measures of intimate relationship functioning are available. We conducted an empirical investigation evaluating the psychometric properties of the South African Relationship Functioning Assessment (SARFA) assessing healthy relationship functioning in N = 150 community members (50% women; M age = 27.2 years) living in the Vulindlela area of KwaZulu-Natal, South Africa. Item development was based on prior qualitative research from two South African communities. All assessments were conducted in isiZulu, participants' primary language. An exploratory factor analysis was conducted on the initial 39-item measure. The best-fitting model consisted of one factor with 22 items. The SARFA's internal consistency was α = .94. Convergent validity was observed via significant positive associations (all rs ≥ .38, p < .001) between the SARFA's total score and measures of trust, emotional intimacy, constructive communication, sexual satisfaction, and relationship control (women only). Divergent validity was observed for women only. Encouraging initial psychometric properties of a culturally-relevant measure of relationship functioning in KwaZulu-Natal may have relevance to other communities and potential to be used in research involving couples and health in chronic disease-burdened communities.

Development and psychometric properties of a self-medication behavior inventory.

Introduction: Self-medication is a prevalent behavior with significant health implications. Understanding its psychosocial determinants can inform preventative strategies and interventions. Methods: We evaluated the psychometric properties of the Self-Medication Behavior Inventory (SMBI-9) in a binational study with 779 Colombian and Mexican participants. Concurrent validity was assessed through correlations with related inventories, and confirmatory factor analysis tested the proposed four-factor model. Results: The SMBI-9 demonstrated high model fit (CFI = 0.995, TLI = 0.991) and invariance across countries. The factors-Social Influence, Attitude toward Medicine, Avoidance, and Prevention-varied significantly with knowledge of medicine, schooling, health insurance status and gender, underscoring the role of social and personal beliefs in self-medication practices. Discussion: SMBI-9 emerged as a reliable tool for capturing the multifaceted nature of self-medication behaviors. Findings highlight the influence of social norms and personal attitudes, suggesting targeted approaches for behavioral interventions.

Italian adaptation of the Multidimensional Iowa Suggestibility Scale (MISS).

Background: Suggestibility is a personality trait that reflects a general tendency to accept messages. The Multidimensional Iowa Suggestibility Scale (MISS) is a self-report scale developed to measure the degree of individuals' perceptions of their suggestibility. This study aimed to adapt the MISS in an Italian sample. Methods: We conducted two studies. In the first study, 345 subjects (270 females (78%), mean age = 36.21 years ± 14.06 SD) completed the translated Italian version of the MISS, composed of five subscales (consumer suggestibility; persuadability; sensation contagion; physiological reactivity; peer conformity). We investigated the structural validity of the scale through confirmatory factor analysis (CFA) testing four measurement models (unidimensional, four-factor, hierarchical four factors, and bifactor) and explored reliability in terms of internal consistency through the McDonald's omega. In the second study, we cross-validated the MISS on a new independent sample. We enrolled 277 participants (196 females (71%), mean age 30.56, SD = 12.58) who underwent the new version of the scale. We performed factor analyses to test structural validity and compared four measurement models. Then, we investigated reliability and conducted a latent variable analysis to explore divergent validity. Results: The CFA in the first study revealed a bifactor solution of the MISS. This structure was interpretable and provided an adequate fit for the data. The final version of the scale was reduced to forty-six items with globally good indices of adaptation. The scale also demonstrated acceptable reliability in terms of internal consistency through the McDonald's Hierarchical Omega. In the second study, we found that the bifactor structure was confirmed. Factor loadings inspection revealed that there was no justification to report only the separate scores for the subscales. We also found that the scale showed good internal consistency, but mixed evidence for divergent validity. Conclusions: In the end, the Italian version of the MISS demonstrated good psychometric properties which will be discussed in detail below.

Design and validation of a diagnostic suspicion checklist to differentiate epileptic from psychogenic nonepileptic seizures (PNES-DSC).

OBJECTIVE: Psychogenic non-epileptic seizures (PNES) are complex clinical manifestations and misdiagnosis as status epilepticus remains high, entailing deleterious consequences for patients. Video-electroencephalography (vEEG) remains the gold-standard method for diagnosing PNES. However, time and economic constraints limit access to vEEG, and clinicians lack fast and reliable screening tools to assist in the differential diagnosis with epileptic seizures (ES). This study aimed to design and validate the PNES-DSC, a clinically based PNES diagnostic suspicion checklist with adequate sensitivity (Se) and specificity (Sp) to discriminate PNES from ES. METHODS: A cross-sectional study with 125 patients (n = 104 drug-resistant epilepsy; n = 21 PNES) admitted for a vEEG protocolised study of seizures. A preliminary PNES-DSC (16-item) was designed and used by expert raters blinded to the definitive diagnosis to evaluate the seizure video recordings for each patient. Cohen's kappa coefficient, leave-one-out cross-validation (LOOCV) and balance accuracy (BAC) comprised the main validation analysis. RESULTS: The final PNES-DSC is a 6-item checklist that requires only two to be present to confirm the suspicion of PNES. The LOOCV showed 71.4% BAC (Se = 45.2%; Sp = 97.6%) when the expert rater watched one seizure video recording and 83.4% BAC (Se = 69.6%; Sp = 97.2%) when the expert rater watched two seizure video recordings. CONCLUSION: The PNES-DSC is a straightforward checklist with adequate psychometric properties. With an integrative approach and appropriate patient history, the PNES-DSC can assist clinicians in expediting the final diagnosis of PNES when vEEG is limited. The PNES-DSC can also be used in the absence of patients, allowing clinicians to assess seizure recordings from smartphones.

Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items.

BACKGROUND: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). METHODS: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. RESULTS: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement. CONCLUSIONS: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.

Development and Psychometric Validation of a Patient-Reported Outcome Measure to Assess the Signs and Symptoms of Chronic Hand Eczema: The Hand Eczema Symptom Diary (HESD).

INTRODUCTION: Chronic Hand Eczema (CHE) is an inflammatory skin disease of the hands. The Hand Eczema Symptom Diary (HESD) is a new patient-reported outcome measure of worst severity of core CHE signs/symptoms. This study aimed to evaluate content and psychometric validity of the HESD. METHODS: The HESD was developed based on the literature and concept elicitation interviews. Qualitative cognitive debriefing interviews were conducted with CHE patients to assess relevance and understanding of items, response options and recall period. Psychometric properties of the HESD (item performance, dimensionality, reliability, validity, responsiveness and estimation of meaningful change thresholds) were then assessed, first using data from a phase 2b trial (NCT03683719), and confirmed using data from the first 280 participants completing the 16-week treatment phase of a phase 3 trial (NCT04871711). RESULTS: Cognitive debriefing supported item refinement and removal of items and confirmed all items were well understood and relevant to patients. Item properties and dimensionality analyses in the phase 2b data supported removal of additional items, resulting in the 6-item HESD included in the phase 3 trial. Unidimensionality was supported by inter-item correlations (all > 0.70) and Rasch analysis. Internal consistency (Cronbach's alpha = 0.96) and test-retest reliability (Intraclass Correlation Coefficient > 0.89) results were very strong. Construct validity was supported by moderate correlations with concurrent measures (0.53-0.64) and significant differences between severity groups (p < 0.001). Large effect sizes for mean change scores in participants that improved and significant differences between change groups indicated the ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 4-points for improvements in 7-day average HESD scores. CONCLUSION: The HESD is the first CHE-specific, patient-reported outcome measure of CHE signs/symptoms developed and validated in line with regulatory guidance. This article provides evidence of strong content validity and psychometric validity and shows improvements of ≥ 4 points on 7-day average HESD scores represent clinically meaningful, important changes. TRIAL REGISTRATION: NCT03683719, NCT04871711.

Psychometric validation of the Danish version of the Major Depression Inventory using data from the Lolland-Falster health study (LOFUS).

PURPOSE: The Major Depression Inventory (MDI) is a widely used self-rating depression scale commonly in primary care in Denmark. It has not been subject to robust psychometric validation in a general population setting. The aim of this study was to evaluate the psychometric measurement properties of the MDI when applied in the general population. METHODS: We evaluated statistical psychometric validity using modern test theory (confirmatory factor analysis, item response theory models and Rasch measurement theory) testing local independence and differential item function across groups defined by gender, age, education, and chronic disease status. Separate analyses across different strata and across different statistical models were employed. RESULTS: Regarding structural validity we consistently identified local dependence for the item two pairs (MDI2,MDI3) and (MDI4,MDI5) across strata. This result was confirmed by bifactor CFA models and item screening. We further identified substantial differential item functioning with respect to age group and with respect to chronic disease. We identified quantified the magnitude of this lack of measurement invariance. CONCLUSION: The MDI is psychometrically valid in homogenous sub populations, but the disclosed evidence of local dependence means that published estimates of its reliability cannot be trusted. The lack of measurement invariance means that the instrument cannot be used to compare individuals or groups unless they are similar in terms of age group and chronic disease status.

The transcultural adaptation and validation of the Chinese version of the Oral Health Literacy Scale for Diabetic Patients.

BACKGROUND: Diabetic patients' oral health concerns are a reality for every diabetic patient in China. The attitudes of diabetic patients toward early identification of oral literacy influence oral literacy in diabetes patients. Diabetes patients' oral health literacy is critical for providing focused education and therapies. However, no instrument exists to measure oral health literacy in Chinese diabetic patients. In this study, the English version of the oral health literacy among people living with diabetes (OHLD) scale was cross-culturally validated to provide a reliable tool for assessing the oral health literacy of diabetic patients in China. OBJECTIVE: The oral literacy among people living with diabetes (OHLD) scale was Chineseized and its reliability and validity tested, and the OHLD scale was revised to test the reliability and validity of the Chinese version of the OHLD scale and to provide a tool for assessing the oral health literacy of diabetic patients in China. METHODS: A modified version of the Brislin translation model was used, cross-cultural adaptation was performed through expert consultation and pre-survey, and expert opinion was used to assess content validity to form the Chinese version of the Oral Health Literacy Scale for Diabetic Patients, which was administered to 420 diabetic patients in two tertiary hospitals in Liaoning Province from March to August 2023. The reliability of the scale was tested. SPSS 25.0 and AMOS 23.0 were used to analyze the data. RESULTS: The Chinese version of the OHLD scale consisted of three dimensions and 10 entries. Structure of the validity analysis: three factors were extracted from the exploratory factors with a cumulative variance contribution of 79.794%; Content validity results:An item's content validity index (I-CVI) was 0.857 to 1 at the entry level, and the content validity index of the scale (S-CVI) was 0.928 at the scale level. The results of the reliability analyses were: the Cronbach's alpha coefficient for the total scale was 0.908; the Cronbach's alpha coefficients for the factors and dimensions were 0.853 to 0.922; the split-half reliability was 0.827; and the test-retest reliability was 0.848. The results of the validation factor analysis showed that (χ2/df) was 1.430, the root mean square of the error of approximation (RMSEA) was 0.045, the comparative fit index (CFI) was 0.989, and the Tucker Lewis index (TLI) was 0.985, which showed that the model had an overall good fit. CONCLUSION: The Chinese version of the OHLD scale has good reliability and validity and can be used as a valid tool for assessing diabetes mellitus patients in China.

Translation and validation into Spanish of the oral health self-efficacy scale in Chilean older adults.

BACKGROUND: Population ageing poses a challenge to improving the well-being of older adults, particularly in terms of oral health. Promoting self-efficacy in oral health behaviours is crucial for maintaining this population's health and quality of life. The Oral Health Self-Efficacy Scale (OHSES) has been widely used to assess dental self-efficacy and is considered comprehensive and reliable. However, there is a need to validate OHSES for Spanish-speaking older adults. This study aimed to assess the reliability and validity of the translated questionnaire for use in the older Chilean population. METHODS: A sample of 188 older adults, aged 60 years and above residing independently in the community, were recruited by accessing databases from the National Senior Citizen Service and various community organisations within the region of La Araucanía. The participants underwent comprehensive oral examinations and oral health interviews, focusing on variables such as OHSES, Oral health-related quality of life (OHIP-14Sp), assessment of remaining teeth, knowledge and attitudes toward oral health, and sociodemographic characteristics. The validity of the translated questionnaire was assessed through translation and cross-cultural adaptation, cognitive debriefing, and face and content validation. The psychometric properties of the questionnaire were evaluated through measures of internal consistency (Cronbach's alpha), content validity (Content validity index), construct validity (factor analysis and Pearson correlation analysis), and test-retest reliability (intraclass correlation). RESULTS: The Spanish version of OHSES demonstrated adequate face and content validity. The confirmatory factor analysis confirmed a two-factor scale with 7 items for a better fit. The scale demonstrated high internal consistency (Cronbach's alpha = 0.821) and acceptable test-retest reliability (ICC = 0.411). Correlations were found between the OHSES score, the number of remaining teeth, knowledge and attitudes towards oral health, and the OHIP-14Sp (p < 0.01). CONCLUSIONS: This study confirms the validity of the Spanish version of the Oral Health Self-Efficacy Scale for older adults in Chile. The scale is expected to be helpful in assessing self-efficacy in dental interventions and collecting data for international comparisons. This research opens new dimensions in patient-reported assessment of oral health.