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Background: The EQ-5D-Y is a generic preference-weighted measure for children and adolescents which was developed within Europe. Two versions exist, the EQ-5D-Y-3L (Y-3L) and EQ-5D-Y-5L (Y-5L). This study aimed to cross-culturally adapt the Y-3L and Y-5L for use in Singapore and to assess the content validity, specifically, the relevance and comprehensiveness of the EQ-5D-Y descriptive system (DS) in Asia. Methods: To culturally adapt the instruments, an expert panel consisting of paediatricians and primary school educators were consulted. Modifications suggested by the expert panel were tested via cognitive debriefing interviews with children aged 8–12 in Singapore. To assess the content validity of the EQ-5D-Y DS, interviews were conducted with both healthy (n = 8) and ill children (n = 6) aged 8–15. In the interviews, children discussed their experience with poor health and commented on the comprehensiveness and relevance of the EQ-5D-Y DS. Results: The cross-cultural adaptation process led to minor modifications to the UK English Y-3L and Y-5L versions, including using phrases familiar to the local children and adding examples to facilitate understanding. The five health dimensions in the EQ-5D-Y DS were spontaneously elicited when children discussed their experience with poor health. All health dimensions related to poor health elicited from the interviews fell into three broad categories: physical health (e.g. Appetite, Mobility, and Sleep), mental well-being (e.g. Annoyed/Frustrated and Scared/Worried), and social relationships (e.g. Family and Friends). The EQ-5D-Y DS was generally found to be relevant and comprehensive, although some health dimensions that may be relevant to the local population (Social relationship and Appetite) were not covered. Conclusions: The UK English EQ-5D-Y instruments were adapted to produce the Singapore English EQ-5D-Y instrument that were comprehensible to local children as young as 8 years old. The EQ-5D-Y DS was generally relevant and comprehensive to measure poor health of local children. Future studies should ascertain the benefits of adding bolt-on items related to social relationships and appetite to the EQ-5D-Y DS. [ABSTRACT FROM AUTHOR]

Background: Patient-Reported Outcomes Measurement Information System (PROMIS®) Dyspnea Activity Motivation & Requirement item pool and sleep related impairments (SRI) item bank are designed in assessing the impact of dyspnea and sleep and guiding patient management. However, to effectively utilize this tool in Arabic-speaking populations, it is essential to perform a thorough translation and cultural adaptation process. Therefore, the aim of the study is to translate and cross-culturally adapt the translated items of the PROMIS® dyspnea activity motivation and requirement and SRI into Arabic. Methods: A universal approach to translation adopted from PROMIS guideline document for translation and cultural adaptation, and the Chronic Illness Therapy translation methodology. The forward translation step followed by back work translation and Harmonization and quality assurance. Cognitive interview and pilot testing was conducted among 30 Arabic respondents across 5 different countries of Arabic speaker to produce a single version for Arab countries. Results: A successful translation and cross-cultural adaptation into Arabic was achieved while maintaining equivalency. The translation was clear and more colloquial sentences were semantically equivalent and easy to understand. Equivalence of meaning of PROMIS® dyspnea activity motivation, requirement and SRI were achieved. All items were appropriate, relevant to culture and it measured the same concept as the original items. In Items 2 of the dyspnea activity motivation related to leisure activity "shopping", the term "catalog and website" was added instead of "catalog only" which makes item in line with the original source but more comprehensive and applicable to current shopping trends. Conclusions: The PROMIS® dyspnea activity motivation, requirement items pool and SRI item bank are culturally and linguistically suitable to be used in Arab country. By extending the accessibility of this measure to Arabic-speaking population, this study contributes significantly to the advancement of management and patient-centered care in the region. Further studies are necessary to evaluate the psychometric properties of these instruments. [ABSTRACT FROM AUTHOR]

Background: Health-related quality of life (HRQOL) measurement has become an important health care outcome even in oncological pediatric scenario. During radiation therapy care path, pediatric patients and their relatives may suffer from emotional and psychosocial distress not only related to cancer diagnosis, but also due to the procedure and the required daily routine. Despite the high prevalence of psychosocial consequences in this setting, instruments that inquire pediatric HRQOL and healthcare satisfaction have rarely been studied in Italy. Purpose of this study was to investigate reliability and linguistic validation of the PedsQL™ healthcare satisfaction Hematology/Oncology module from its original English version to Italian language. Methods: Three phases standard procedure of cross-culture adaptation were used to create Italian version of PedsQL™ healthcare satisfaction Hematology/Oncology module. Forward translations and backward translations were performed. Finally, a pilot-testing for understandability of the 'pre-final' version was conducted with parents of children attending our Radiotherapy Center using two methodologies of Cognitive Interviewing ("Think-aloud Interviews" and "Respondent Debriefing"), in order to obtain the final Italian version of the PedsQL™ healthcare satisfaction Hematology/Oncology module. Results: Twenty-five parents (2 father, 23 mothers) were recruited during their children's radiotherapy treatment and the grammatically and conceptually acceptable pre-final version of the PedsQL™ Healthcare Satisfaction Hematology/Oncology Module was administered. The questionnaire was well understood reflecting its linguistic adaptation. Compliance with questionnaire administration was optimal. All subjects stated that the questions were interesting to express their opinion, most of them reported that all the questions of each section were clearly comprehensible and easy to understand, suggesting minimal changes that were double-checked with back translation. Furthermore, six of them spontaneously asked to complete the questionnaire in order to review the assistance received during radiotherapy. Conclusion: Our Italian version of the PedsQL™ 3.0 Healthcare Satisfaction Hematology/Oncology Module seems to be a valid and functional instrument to indagate Healthcare Satisfaction. [ABSTRACT FROM AUTHOR]

Background: Patients with multiple long-term conditions often face a variety of challenges arising from the requirements of their health care. Knowledge of perceived treatment burden is crucial for optimizing treatment. In this study, we aimed to create a German version of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and to evaluate its validity.Methods: The steps to translate the MTBQ included forward/back translation, cognitive interviews (n = 6) and a pilot test (n = 7). Psychometric properties of the scale were assessed in a cross-sectional survey with primary care patients aged 65 and older with at least 3 long-term conditions (n = 344). We examined the distribution of responses, dimensionality, internal reliability and construct validity.Results: Cognitive interviewing and piloting led to minor modifications and showed overall good face validity and acceptability. As expected, we observed a positively skewed response distribution for all items. Reliability was acceptable with McDonald's omega = 0.71. Factor analysis suggested one common factor while model fit indices were inconclusive. Predefined hypotheses regarding the construct validity were supported by negative associations between treatment burden and health-related quality of life, self-rated health, social support, patient activation and medication adherence, and positive associations between treatment burden and number of comorbidities. Treatment burden was found to be higher in female participants (Mdn1 = 6.82, Mdn2 = 4.55; U = 11,729, p = 0.001) and participants with mental health diagnoses (Mdn1 = 9.10, Mdn2 = 4.55; U = 3172, p = 0.024).Conclusions: The German MTBQ exhibited good psychometric properties and can be used to assess the perceived treatment burden of patients with multimorbidity. [ABSTRACT FROM AUTHOR]

Background: End-of-life care decision-making has become important to support dignity and quality of life for patients who are facing death in Korea, along with the enactment of the Life-Sustaining Treatment Act in 2018. However, it seems that the concepts and policies related to the law are not yet familiar to health care providers or the general public. This unfamiliarity can hinder efficient end-of-life care discussions. Therefore, the purpose of this study was to propose a valid and reliable tool to explore the level of understanding of concepts and attributes related to end-of-life care decisions.Methods: This is a mixed-methods study design. A relevant law and literature analysis, expert consultation, cognitive interviews of 10 adults, and cross-sectional survey for psychometric tests using data from 238 clinical nurses were performed to update a tool developed before the life-sustaining treatment Act was enacted in Korea.Results: 29 items of the draft version were polished in terms of literacy, total length, and scoring method via cognitive interviews and finalized into 21 items through psychometric tests and expert consultations. The 21 items conformed to the Rasch unidimensional paramenters.Conclusion: A tool to identify the level of understanding of concepts related to end-of-life care decisions was proposed through a rather rigorous process to ensure feasibility and validity/reliability. We recommend the proposed tool to apply to the adult population and nurses for evaluation and educational purposes. [ABSTRACT FROM AUTHOR]

Background: Late-life experiences such as protracted and indisposing medical disorders can negatively impact older adults' psychological and mental health, making them vulnerable to depression. Majority of the assessment tools for depression were developed for use in western countries. There is therefore the need for availability of culture- and environment-specific tools for assessment of depression in low-and-middle-income countries. This study was designed to cross-culturally adapt and validate the Geriatric Depression Scale-15 (GDS-15) into Igbo language and culture.Methods: The English version of the GDS-15 was translated into Igbo language; synthesized, back-translated, and underwent expert panel review, pretesting and cognitive debriefing interview, according to the American Academy of Orthopedic Surgeons' guidelines. The Igbo version of the GDS-15 was tested for concurrent and structural validities, and internal consistency among consecutively recruited 140 consenting older adults (62.9% females) in Enugu North Senatorial District at 0.05 level of significance.Results: The English version of the GDS-15 was successfully cross-culturally adapted to Igbo with all the 15 items still retained on the Igbo version of the GDS-15. The Igbo version of the GDS-15 exhibited the same structure as the English version, and displayed a Cronbach's alpha value of 0.53 with no significant ceiling (0%) and floor (0%) effects. The correlation between the participants' total scores on the Igbo and the English versions of the GDS-15 (ρ = 0.86) was adequate. There was no significant difference between corresponding scores in the English and Igbo versions of the GDS-15 (p = 0.89).Conclusions: The Igbo version of the GDS-15 is a valid and culturally specific instrument, and can be used for assessing depression among Igbo older adults in Nigeria. [ABSTRACT FROM AUTHOR]

Background: To develop a priority-based patient/parent reported outcome measure for children with lower-limb differences (LD) by adapting the Gait Outcomes Assessment List (GOAL) questionnaire.Methods: Guided by a conceptual framework of patient priorities, the GOAL questionnaire was iteratively modified and its sensibility evaluated by field-testing it on children with LD, and their parents. Cognitive interviews were conducted with a subgroup of these children, and an e-survey administered to a multidisciplinary group of health care professionals with expertise in paediatric LD. Findings were integrated to create the final version of the GOAL-LD.Results: Twenty-five children (9-18 years), 20 parents, and 31 healthcare professionals evaluated the content and sensibility of the GOAL, with an emphasis on the relevance and importance of the items to patients' health related quality of life (HRQL). This resulted in the retention of 26 of the original 50 items, elimination of 12, modification of 12, and addition of seven new items. The new 45-item GOAL-LD questionnaire was shown to be sensible, and its content deemed important.Conclusions: The GOAL-LD questionnaire has a high level of face and content validity, and sensibility. It comprehensively captures the HRQL goals and outcomes that matter to children with LD and their parents. Following further psychometric evaluation, the GOAL-LD may serve as a much needed patient and parent reported outcome measure for this population. [ABSTRACT FROM AUTHOR]

Purpose: The Autism Behavior Inventory (ABI) is an observer-reported outcome scale measuring core and associated features of autism spectrum disorder (ASD). Extensive scale development (reported elsewhere) took place, in alignment with the Food and Drug Administration's patient-reported outcome guidance, to address the need for instruments to measure change and severity of ASD symptoms.Methods: Cognitive interviewing was used to confirm understanding and content validity of the scale prior to its use in clinical trials. Respondents were caregivers of individuals with ASD (N = 50). Interviews used a hybrid of the "think-aloud" and verbal probing approach to assess ABI's content validity and participant understanding of the instrument, including: item clarity and relevance; item interpretation; appropriateness of response scales; and clarity of instructions. Audio-recordings of the interviews were transcribed for qualitative data analysis. The scale was revised based on participant feedback and tested in a second round of interviews (round 1 N = 38, round 2 N = 12).Results: In total, 67/70 items reached ≥ 90% understandability across participants. Caregivers were able to select an appropriate response from the options available and reported finding the examples helpful. Based on participant feedback, instructions were simplified, 8 items were removed, and 10 items were reworded. The final revised 62-item scale was presented in round 2, where caregivers reported readily understanding the instructions, response options, and 61/62 items reached ≥ 90% understandability.Conclusions: Cognitive interviews with caregivers of a diverse sample of individuals with ASD confirm the content validity and relevance of the ABI to assess core and associated symptoms of ASD. [ABSTRACT FROM AUTHOR]

Background: Accurate diagnosis of carpal tunnel syndrome (CTS) is essential for directing appropriate treatment; and for making decisions about work injury claims. The Kamath and Stothard Questionnaire (KSQ) is a self-reported tool used for the diagnosis of CTS. Comprehensibility and comprehensiveness of this questionnaire are critical to diagnostic performance and need to be established. The purpose of the study was to describe how potential respondents, clinicians, and measurement researchers interpret KSQ questions in order to identify and resolve potential sources of misclassification.Methods: Hand therapists, measurement researchers, participants with CTS, and a control group were interviewed using cognitive interviewing techniques (talk aloud, semi-structured interview probes) in Hamilton, Canada. All interviews were recorded and transcribed verbatim. A directed content analysis was done to analyze the interviews using a previously established framework.Findings: Eighteen participants were interviewed. Areas, where questions were unclear to some participants, were recorded and categorized into five themes: Clarity and Comprehension (52%), Relativeness (38%), Inadequate Response Definition (4%), Perspective Modifiers (4%), and Reference Point (2%). Respondents also identified several symptoms of CTS that are not covered by the KSQ that might be of diagnostic value, e.g., weakness and dropping items.Conclusion: The content validity of the current iteration of the KSQ was not established. The problematic questions identified in the study have been reported to have low specificity and negative predictive values in a previous quantitative study. The content validity issues identified may explain the poor performance. Recommendations were made to modify the wording of the KSQ and the potential addition of three new questions. Future studies should determine whether the modified questionnaire can provide better diagnostic accuracy and psychometric properties. The results of this study may assist in ruling in or out CTS diagnosis to a wide variety of target audience, such as hand specialists, physical and occupational therapists, as well as family doctors. [ABSTRACT FROM AUTHOR]

Background: The shortened version of the Western Ontario Rotator Cuff Index (Short-WORC) is a patient reported outcome measure that evaluates quality of life (QoL) of patients with rotator cuff pathology. However, formal content validation of the full or Short-WORC has not been reported. This study aims to understand how 1) people interpret and calibrate responses to items on the Short-WORC and 2) compensatory strategies that might enhance function and thereby affect responses.Methods: This study uses cognitive interviewing, a qualitative methodology that focuses on the interpretation of questionnaire items. Patients with rotator cuff disorders (n = 10), clinicians (n = 6) and measurement researchers (n = 10) were interviewed using a talk aloud structured interview that evaluated each of the 7 items of the Short-WORC. All interviews were recorded and transcribed verbatim by one researcher (R.F). Analysis was done through an open coding scheme using a previously established framework.Results: Overall, the items on the Short-WORC were well received by participants. Through the interviews, the 6 themes of: Comprehension, Inadequate response definition, Reference Point, Relevance, Perspective Modifiers and Calibration Across Items emerged. The items of working above the shoulder (90%), compensating with the unaffected arm (88%) and lifting heavy objects (92%) were the most relevant to participants. Participants calibrated their scores on the items of sleeping and styling (19%) the most. Perspective modifiers of gender, influenced the calibrations of items of styling your hair (30%) and dressing or undressing (19%). Compensatory strategies of task-re allocation and using assistive devices/resources were frequently mentioned by participants. Overall, participants had minor comprehension issues, but found the 7- items of the Short-WORC to be relevant to QoL.Conclusions: Therefore, the findings demonstrate that the Short-WORC is not cognitively complex, but varies with patient perspectives. Overall, the Short-WORC provides evidence of demonstrating strong content validity when used for rotator cuff disorder patients. [ABSTRACT FROM AUTHOR]

Objectives: To develop separate item banks for three health domains of health-related quality of life (HRQOL) ranked as important by Singaporeans - physical functioning, social relationships, and positive mindset.Methods: We adapted the Patient Reported Outcomes Measurement Information System Qualitative Item Review protocol, with input and endorsement from laymen and experts from various relevant fields. Items were generated from 3 sources: 1) thematic analysis of focus groups and in-depth interviews for framework (n = 134 participants) and item(n = 52 participants) development, 2) instruments identified from a literature search (PubMed) of studies that developed or validated a HRQOL instrument among adults in Singapore, 3) a priori identified instruments of particular relevance. Items from these three sources were "binned" and "winnowed" by two independent reviewers, blinded to the source of the items, who harmonized their selections to generate a list of candidate items (each item representing a subdomain). Panels with lay and expert representation, convened separately for each domain, reviewed the face and content validity of these candidate items and provided inputs for item revision. The revised items were further refined in cognitive interviews.Results: Items from our qualitative studies (51 physical functioning, 44 social relationships, and 38 positive mindset), the literature review (36 instruments from 161 citations), and three a priori identified instruments, underwent binning, winnowing, expert panel review, and cognitive interview. This resulted in 160 candidate items (61 physical functioning, 51 social relationships, and 48 positive mindset).Conclusions: We developed item banks for three important health domains in Singapore using inputs from potential end-users and the published literature. The next steps are to calibrate the item banks, develop computerized adaptive tests (CATs) using the calibrated items, and evaluate the validity of test scores when these item banks are administered adaptively. [ABSTRACT FROM AUTHOR]

Background: Social care-related quality of life is a key outcome indicator used in the evaluation of social care interventions and policy. It is not, however, always possible to collect quality of life data by self-report even with adaptations for people with cognitive or communication impairments. A new proxy-report version of the Adult Social Care Outcomes Toolkit (ASCOT) measure of social care-related quality of life was developed to address the issues of wider inclusion of people with cognitive or communication difficulties who may otherwise be systematically excluded. The development of the proxy-report ASCOT questionnaire was informed by literature review and earlier work that identified the key issues and challenges associated with proxy-reported outcomes.Methods: To evaluate the acceptability and content validity of the ASCOT-Proxy, qualitative cognitive interviews were conducted with unpaid carers or care workers of people with cognitive or communication impairments. The proxy respondents were invited to 'think aloud' while completing the questionnaire. Follow-up probes were asked to elicit further detail of the respondent's comprehension of the format, layout and content of each item and also how they weighed up the options to formulate a response.Results: A total of 25 unpaid carers and care workers participated in three iterative rounds of cognitive interviews. The findings indicate that the items were well-understood and the concepts were consistent with the item definitions for the standard self-completion version of ASCOT with minor modifications to the draft ASCOT-Proxy. The ASCOT-Proxy allows respondents to rate the proxy-proxy and proxy-patient perspectives, which improved the acceptability of proxy report.Conclusions: A new proxy-report version of ASCOT was developed with evidence of its qualitative content validity and acceptability. The ASCOT-Proxy is ready for empirical testing of its suitability for data collection as a self-completion and/or interview questionnaire, and also evaluation of its psychometric properties. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process. Methods: Concept elicitation focus groups and individual interviews were conducted with patients with HF to identify concepts for the instrument. Cognitive interviews with HF patients were used to confirm that no essential concepts were missing and to assess patient comprehension of the instrument and items. Results: During concept elicitation, the most frequently reported HF symptoms were shortness of breath, tiredness, fluid retention, fatigue, dizziness/light-headedness, swelling, weight fluctuation, and trouble sleeping. Two measures were developed based on the concepts: the Heart Failure Symptom Diary (HF-SD) and the Heart Failure Impact Scale (HFIS). Findings from cognitive interviews suggested that the items in the HF-SD and HFIS were relevant and well understood by patients. Multiple iterations of concept elicitation and cognitive interviews were needed based on FDA request for a broader patient population in the qualitative study. Lessons learned from the omecamtiv mecarbil PRO/clinical development program are discussed, including challenges of qualitative studies, patient recruitment, expected and actual timelines, cost, and engagement with various stakeholders. Conclusion: Development of a new PRO measure to support a label claim requires significant investment and early planning, as demonstrated by the omecamtiv mecarbil program. [ABSTRACT FROM AUTHOR]

Background: The EQ-5D is frequently used to derive utilities for patients with type 2 diabetes (T2D). Despite widely available quantitative psychometric data on the EQ-5D, little is known about content validity in this population. Thus, the purpose of this qualitative study was to examine content validity of the EQ-5D in patients with T2D.Methods: Patients with T2D in the UK completed concept elicitation interviews, followed by administration of the EQ-5D-5L and cognitive interviewing focused on the instrument's relevance, clarity, and comprehensiveness.Results: A total of 25 participants completed interviews (52.0 % male; mean age = 53.5 years). Approximately half (52 %) reported that the EQ-5D-5L was relevant to their experience with T2D. When asked if each individual item was relevant to their experience with T2D, responses varied widely (24.0 % said the self-care item was relevant; 68.0 % said the anxiety/depression item was relevant). Participants frequently said items were not relevant to themselves, but could be relevant to patients with more severe diabetes. Most participants (92.0 %) reported that T2D and/or its treatment/monitoring requirements had an impact on their quality of life that was not captured by the EQ-5D-5L. Common missing concepts included food awareness/restriction (n = 13, 52.0 %); activities (n = 11, 44.0 %); emotional functioning other than depression/anxiety (n = 8, 32.0 %); and social/relationship functioning (n = 8, 32.0 %).Conclusions: The results highlight strengths and potential limitations of the EQ-5D-5L, including missing content that could be important for some patients with T2D. Suggestions for addressing limitations are provided. [ABSTRACT FROM AUTHOR]

Background: Engaging adolescents in decisions about their health may enhance their compliance with treatment and result in better health outcomes. Treatment outcomes in attention-deficit/hyperactivity disorder (ADHD) are rarely evaluated from the adolescents' point of view. There is also concern that adolescents with ADHD may not have insight about the impacts of their disease. This article describes research conducted to understand the experiences of adolescents with ADHD and how the research was used to develop an adolescent self-report instrument. Methods: This research involved an iterative process to ensure content validity and was conducted in the following stages: concept identification from literature reviews and interviews with teachers and clinicians; concept elicitation interviews with adolescents with ADHD and their caregivers, review of existing instruments; development of a new instrument and cognitive interviews. Experts in instrument development and translation and clinical practitioners in ADHD also participated. Results: A conceptual framework to measure the impact of ADHD on adolescent functioning identified from concept identification research informed concept elicitation interviews with 60 adolescents with ADHD and their primary caregivers. In the interviews, adolescents discussed difficulties with performing activities in various contexts: school, home, leisure activities and social interactions. Caregivers provided additional insights. The instrument review revealed that none of the existing instruments were suitable to collect data on the elicited concepts; therefore, a new instrument was developed. Revisions were made to the format and content of the instrument (a daily diary) based on feedback received from cognitive testing with 15 adolescents. Conclusions: Our research helped to obtain a comprehensive understanding of the impacts of ADHD on adolescent functioning, to inform the development of a new instrument for measuring outcomes. Adolescents were able to discuss the impact of ADHD on their lives in concept elicitation interviews and report the impacts of ADHD on a self-report instrument. The new instrument developed to reflect the perspective of adolescents with ADHD can be used to supplement outcome assessments in clinic and research settings. Scientific advocacy for the use of such measures can be valuable to measure outcomes meaningful to adolescents with ADHD and the clinical community. [ABSTRACT FROM AUTHOR]

Aim: Preliminary content validity testing of a UK Patient Reported Outcome Measure (PROM) for use in cardiac arrhythmia patients undergoing ablation treatment. Methods: Twenty five patients diagnosed with symptomatic cardiac arrhythmias participated in qualitative interviews to obtain their perspective of a draft PROM. As part of the process to establish preliminary content validity, patients were asked to complete the questionnaires and to identify missing and redundant items within the PROM, while also reviewing the instructions and formatting. The questionnaires were updated iteratively to reflect patient feedback. Results: Recurring themes were identified during qualitative interviews leading to improvements to the tool. Following modification of the PROM, based on patient feedback, subjects reported that the tool was fully inclusive and easy to comprehend. Patients found the instructions and layout of the tool acceptable and easy to use. Conclusion: Qualitative patient interviews are an important part of PROM tool development. In the case of this cardiac ablation PROM, it enabled end users to assess the tool for inclusivity and accessibility, and to ensure that it addressed concerns important to the patient. Cognitive interviews were able to obtain patients' perspectives to establish face validity and content validity of the PROM. This is part of a process which will ensure that this disease-specific PROM measures cardiac arrhythmia patient symptoms and impact on patients' lives accurately and sensitively. The next study will use the PROM prospectively in over 450 arrhythmia patients to prospectively validate the tool. Condensed abstract: Patients diagnosed with symptomatic cardiac arrhythmias provided feedback through cognitive interviews to facilitate improvements in a new disease specific PROM establishing preliminary face and content validity. [ABSTRACT FROM AUTHOR]

Background: There has been considerable interest in using the Adult Social Care Outcomes Toolkit (ASCOT), developed in England, to measure quality-of-life outcomes of long-term care (LTC-QoL) service provision in national and cross-national studies.Objectives: The aim of this study was to translate and culturally adapt the original ASCOT service user measure into German and to evaluate its content and construct validity in Austrian home care service users.Methods: The translation and cultural adaptation process followed the ISPOR TCA guidelines. We used qualitative data from six cognitive debriefing interviews with Austrian recipients of home care services to assess linguistic and content validity. In addition, cross-sectional survey data (n = 633) were used to evaluate construct validity by testing hypothesized associations established in a previous study for the original English ASCOT service user instrument.Results: Cognitive debriefing interviews confirmed that the German adaptation of the ASCOT service user instrument was understood as intended, although two domains ('Control over daily life' and 'Dignity') and selected phrases of the response options were challenging to translate into German. All ASCOT domains were statistically significantly associated with related constructs and sensitive to service user sub-group differences.Conclusions: We found good evidence for a valid cross-cultural adaptation of the German version of ASCOT for service users. The analysis also supports the construct validity of the translated instrument and its use in evaluations of QoL-effects of LTC service provision in German-speaking countries. Further research on the reliability and feasibility in different care settings is encouraged. [ABSTRACT FROM AUTHOR]

Background: The Mental Health Continuum-Short Form (MHC-SF) is a measure of positive mental health and flourishing, which is widely used in several countries but has not yet been validated in Denmark. This study aimed to examine its qualitative and quantitative properties in a Danish population sample and compare scores with Canada and the Netherlands.Methods: Three thousand five hundred eight participants aged 16-95 filled out an electronic survey. Both the unidimensional and multidimensional aspects of the Danish MHC-SF were studied through bifactor modelling. Cognitive interviews examined face validity and usability.Results: The general score of the Danish MHC-SF was reliable for computing unit-weighted composite scores, as well as using a bifactor model to compute general factor scores or measurement models in an SEM context. Nonetheless, subscale scores were unreliable, explaining very low variance beyond that explained by the general factor. The participants of the qualitative interviews observed problems with wording and content of the items, especially from the social subscale. The general score correlated with other scales as expected. We found substantial variation in flourishing prevalence rates between the three cultural settings.Conclusions: The Danish MHC-SF produced reliable general scores of well-being. Most of the issues observed regarding the subscale scores have been shown in previous research in other contexts. The further analysis of indices of the bifactor model and the inclusion of qualitative interviews allowed for a better understanding of the possible sources of problems with the questionnaire's subscales. The use of subscales, the substantive understanding of the general score, as well as the operationalization of the state of flourishing, require further study. [ABSTRACT FROM AUTHOR]