Cognitive Debriefing Research Articles

Development of novel patient-reported outcome instruments to assess atopic dermatitis-associated dyspigmentation and xerosis in patients with skin of colour.

The prevalence and burden of atopic dermatitis (AD) are disproportionately high in individuals with skin of colour (SOC). Previous research shows that risk for xerosis and/or dyspigmentation is heightened in this population and may be more bothersome. However, there are no patient-reported instruments developed specifically for these disease sequelae in patients with SOC. To develop and perform content validation of patient-reported outcome (PRO) questionnaires to assess AD-related xerosis and dyspigmentation in patients with SOC. A targeted literature review was conducted to understand and identify AD-related disease sequelae and quality-of-life impacts relevant to patients with SOC and any instruments used to assess AD in the target population. Two draft PRO questionnaires assessing xerosis (X-AD) and dyspigmentation (D-AD) were developed and refined following advice meetings with clinical experts (N = 3). Questionnaire content validity was explored during hybrid concept elicitation (CE) and cognitive-debriefing (CD) interviews with adult and adolescent patients with SOC who have moderate-to-severe AD (N = 15). Ten concept-focused articles, three websites, 17 labels, one United States Food and Drug Administration compendium and one clinical trial confirmed xerosis and dyspigmentation were important AD-related disease sequelae. Patients with SOC (46.7% female; age range 12.2-76.1 years) reported that each questionnaire was relevant to their AD experience in an appropriate recall timeframe, were readily understood and meaningful responses were easy to select. The final X-AD consisted of one 11-point numeric rating scale (NRS) assessing xerosis severity and two items assessing the level of bother associated with xerosis appearance and feeling over the past week (0-4 verbal rating scale). The final D-AD consisted of two 11-point NRS items assessing dyspigmentation severity and two items assessing the level of bother associated with how dyspigmentation looked over the past week. The X-AD/D-AD questionnaires were well understood and effective in capturing the experiences of xerosis and dyspigmentation in the target population in an appropriate and comprehensive way. The study supports the initial development of the questionnaires in accordance with regulatory guidelines and best practices, however psychometric validation is required to evaluate the properties of each questionnaire and develop score interpretation guidelines.

COping with Rheumatic Stressors (CORS) questionnaire: validated German translation and cross-cultural adaptation for patients with axSpA

BackgroundPatients with Rheumatic and Musculoskeletal Diseases, including axial spondyloarthritis (axSpA), may suffer from stressors like pain and functional impairments leading to limitations in their self-perceived health status. The COping with Rheumatic Stressors (CORS) questionnaire was developed to analyze how patients cope with these stressors. The CORS is currently not available in German.ObjectiveFirst, to translate, cross-culturally adapt and to linguistically validate the original Dutch CORS into German. Second, to test the pre-final German translation through cognitive debriefing in patients with axSpA.MethodologyThe original Dutch CORS underwent a multistep cross-cultural adaptation process, as described by Beaton. It was first independently translated into German by bilingual Dutch-German lay and expert translators. Subsequently, it was translated back from the German version into Dutch. Remaining discrepancies were resolved by a scientific committee, resulting in a pre-final German version. This version was then tested through cognitive debriefing by 10 patients with axSpA across a broad spectrum of sociodemographic backgrounds.ResultsForward and backward translations of the CORS revealed minor discrepancies, mainly based on the degree of formal versus informal language usage, minor semantic errors or unusual syntax, which led to minor modifications in the wording. Reviewed by the scientific committee, the pre-final consensus German version was linguistically validated by cognitive debriefing by 10 patients with axSpA. Cognitive debriefing confirmed and ensured closest linguistic validity for German in Germany and highest equivalence to the Dutch original version.ConclusionThe German CORS was shown to have high cross-cultural and face validity for the assessment of coping with rheumatic stressors.

Translation, Reliability and Validity of the Chinese Version of the Confidence in Dementia Scale for Clinical Nursing: A Cross-Sectional Study.

To translate the 9-item Confidence in Dementia (CODE) scale into Chinese (Confidence in Dementia-Chinese, CODE-C) and evaluate its psychometric properties among clinical nurses. With the rapidly ageing population, an increasing number of patients with dementia will be cared for in hospitals. Clinical nurses' confidence in dementia care is crucial to provide quality care. A reliable and valid assessment tool is urgently needed to measure confidence in dementia and identify educational needs in hospitals. The CODE applies to other societies, and this study aims to standardise this scale for China. This was a cross-sectional study. Following the principles of Brislin bidirectional translation, literal translation, back-translation, expert consultation, cognitive debriefing and preliminary testing were performed, and the CODE-C was preliminarily revised. Internal consistency and test-retest reliabilities with a 2-week interval were tested, and an item analysis was conducted using the Pearson correlation coefficient method. Validity was evaluated, including content, construct, convergent, discriminant and criterion validity. A total of 452 Chinese-speaking nurses from three hospitals in Jinan, China, completed the survey. The scores of each item and the total score of the CODE-C were positively correlated (r = 0.626-0.802, p < 0.05). The difference between the high-score group and the low-score group for each item of the CODE-C was significant (p < 0.05). The Cronbach's α coefficient, Spearman-Brown coefficient and Guttman split-half coefficient of the CODE-C were 0.894, 0.842 and 0.838, respectively, and the test-retest reliability was 0.892. The scale- and item-level content validity indices were both 1.00. The confirmatory factor analysis model only marginally supported the three-factor structure. Positive correlations were noted between the CODE-C and the General Self-Efficacy Scale (r = 0.476, p < 0.01), suggesting acceptable concurrent validity. The CODE-C showed acceptable reliability and validity and can be applied to measure the level of confidence in dementia and the outcome of educational interventions aimed at enhancing dementia care among Chinese clinical nurses. The CODE-C can be used as a valid scale to assess the level of confidence in dementia among clinical nurses and help them recognise and improve their level of dementia care.

Qualitative evaluation of survey questions to assess treatment preference for daily oral or long‑acting injectable antiretroviral therapy among people living with HIV.

Treatment of HIV has historically required taking daily oral antiretroviral therapy (ART). A recent alternative to daily oral ART is long-acting injectable ART with cabotegravir plus rilpivirine, administered monthly or every 2 months. The purpose of this qualitative study was to evaluate the concept relevance and interpretability of five previously developed questions: one treatment preference question and four questions designed to assess how the emotional burden associated with HIV treatment impacts treatment preferences. Thirty adults in the United States currently receiving HIV treatment were enrolled in a cross-sectional study involving one-on-one concept confirmation and cognitive debriefing interviews. Concept confirmation interviews included topics, questions, and probes designed to elicit information about the emotional burden of HIV and current perceptions of a participant's treatment regimen. Cognitive debriefing assessed the relevance and clarity of instructions, questions, response options, and recall periods. Transcripts were analyzed with MAXQDA. Mean age of participants was 49 years (range: 29-68), with 60% being male and 40% female. Racial demographics included Blacks (40%), Whites (40%), and other (20%). During concept confirmation, participants endorsed concepts relevant to HIV treatment preference: fear of disclosure of HIV status (47%), forgetting to take daily oral medication (40%), and current treatment regimen as a bothersome daily reminder of HIV status (40%). During cognitive debriefing, participants interpreted the instructions, question, response options, and recall periods as intended for the treatment preference question. Additionally, participants confirmed that the preference question's response options were appropriate and relevant to the experiences of people living with HIV. Participants also consistently interpreted the questions related to fear of disclosure of HIV status, anxiety associated with forgetting to take HIV medication, and HIV medication being an uncomfortable reminder of HIV status; however, participants provided variable responses to the question designed to assess treatment ease of use. These results support the concept relevance and interpretability of the single treatment preference question and three of the four emotional well-being questions among adults living with HIV.

Assessing ambulance staff attitudes toward mental health conditions: translation and psychometric evaluation of the medical condition regard scale among ambulance staff

IntroductionAmbulance staff play a crucial role in responding to mental health crises. However, negative regard toward patients with mental health conditions can hinder care. The Medical Condition Regard Scale (MCRS) assesses regards or attitudes but has not previously been validated for educated ambulance staff and has never been translated into Norwegian. This study aims to translate the instrument into Norwegian, test it on a population of ambulance staff, explore the psychometric properties of the Norwegian version, and measure regard for patients with psychosis.MethodThe MCRS is an 11-item instrument with a Likert scale of 1–6. Possible sum scores range from 11 to 66 (higher score = more positive regards). We chose “psychosis” as the condition to investigate. Translation followed eight steps: (1) preparation, (2) forward translation, (3) backward translation, (4) first expert panel review, (5) harmonisation, (6) cognitive debriefing, (7) second expert panel review, and (8) writing of the final version. The instrument was tested and re-tested regarding the condition “psychosis” on a representative sample of 114 Norwegian ambulance staff in 2023, with a temporal gap of one month. We explored item scores and distribution, as well as floor and ceiling effects. We tested the internal consistency of the items using Cronbach’s Alpha and consistency in answers over time (test and re-test) using the Paired Sample-T test. We used factor analyses to explore the inter-item relationships of the items.ResultsThe 114 participants had a mean sum score of 47, which is mid-range. The scale has a ceiling effect on five items, which was not described in detail earlier. Two items regarding the monetary spending on patients with the given condition had the largest ceiling effects. However, the Norwegian translation showed adequate internal consistency (Cronbach’s Alpha = 0.82) and is reliable over time. Test and re-test showed no significant differences in the scale’s total score (Paired sample T-test, p > 0.05). Exploratory and confirmatory factor analyses indicate that the scale should be used as a one-dimensional instrument in a Norwegian setting in ambulance staff populations.ConclusionThe Norwegian translation of the MCRS is a reliable instrument for ambulance staff measuring medical condition regards. However, the ceiling effect limits the ability to discern differences among high-scoring individuals. Ambulance staff’s regard for patients with psychosis is medium positive (mid-range level), but slightly more positive than what is reported in the international literature regarding patients with mental health issues.

Cross‐Cultural Translation of the Adolescent Menstrual Bleeding Questionnaire (AMBQ)

ABSTRACTAimHeavy menstrual bleeding (HMB) affects up to 37% of adolescents. Given the paucity of available tools to assess health‐related quality of life (HRQoL) in adolescents with HMB, we developed the adolescent menstrual bleeding questionnaire (aMBQ), a valid and reliable measure of bleeding‐related quality of life. The aim of this study was cross‐cultural translation and adaptation of the English aMBQ into French to ensure accessibility for more Canadian adolescents who menstruate.MethodsA five‐step process was followed: (1) forward translation from English to Canadian French; (2) backward translation from French to English; (3) review of source and translated aMBQ to create a reconciled version; (4) cognitive debriefing to ensure linguistic and clinical equivalence and (5) review of cognitive debriefings to produce the final version of the French aMBQ. Results of cognitive debriefings were reviewed after every three participants; items were revised if presented as an issue by ≥2 participants. These changes were implemented and tested in cognitive debriefings until saturation was reached.ResultsLinguistic changes were made to nine (33%) of the questions and one (3.7%) answer options. Major changes were made to four of the 27 questions (15%), and minor changes were made to five of the 27 questions (19%).ConclusionProfessional translators, clinical experts and patient input through cognitive debriefing are pivotal to successful cross‐cultural translation. Results of cognitive debriefing interviews suggest the French aMBQ is easily understood and confirms its face validity.

Chronic rhinosinusitis with nasal polyps (CRSwNP) symptom verbal response scales: content validity testing for use in adults with CRSwNP

BackgroundPRO measures of symptoms in clinical trials have historically utilized visual and numerical scales but verbal descriptors may make it easier for patients to clearly differentiate between response options. This study assessed content validity and meaningful change in five verbal response scales (VRSs) used to assess chronic rhinosinusitis with nasal polyp (CRSwNP) symptom severity.MethodologyThis qualitative, semi-structured interview study recruited adults from the US, Germany, and China with confirmed moderate-to-severe CRSwNP. Interviews included a concept elicitation section, where participants were asked about their experience of living with CRSwNP including symptoms and health-related quality-of-life impacts, and a cognitive debriefing section, where participants were debriefed and participant understanding and real-life relevance of the CRSwNP symptom VRS content were assessed. Interview transcripts were qualitatively analyzed using thematic analysis methods.ResultsAmong the 24 participants interviewed, the most frequently reported CRSwNP symptoms were nasal obstruction, runny nose, mucus in the throat, loss of smell and facial pain/pressure. Participants demonstrated good understanding of the CRSwNP symptom VRS instructions, items, recall period, and response options. The five CRSwNP symptom VRS items were relevant to the majority of participants’ experience of CRSwNP. At the item level, a one-category within-person improvement was the level most frequently reported by participants to be a meaningful change.ConclusionThe CRSwNP symptom VRSs assess relevant and bothersome symptoms experienced by patients with moderate-to-severe CRSwNP, supporting content validity of this measure. The findings of this study provided preliminary insights into meaningful change in the VRS. Further quantitative assessment of meaningful change is needed, and psychometric evaluation of the CRSwNP symptom VRSs will be required to evaluate their appropriateness for assessment of clinical trial endpoints in patients with CRSwNP.

Exploring mHealth app utilization for diabetes self-management: survey insights from a northern district in Malaysia

BackgroundMobile health applications (mHealth apps) offer potential benefits for improving diabetes management, such as better glucose monitoring and patient engagement, but their widespread adoption faces challenges, including privacy concerns and user adherence. This research investigates mHealth app usage among patients living with diabetes in Kinta District, Perak, exploring experiences, challenges and patient perceptions regarding diabetes management using mHealth apps.MethodologyA cross-sectional community survey was conducted in September till November 2020 across nine government health clinics focusing on diabetes mellitus (Type 1 or Type 2) patients, aged 18 years and older, receiving Diabetes Medication Adherence Counseling (DMTAC) services and able to use smart devices. A self-developed questionnaire with four sections was used to gather demographic information, explore mHealth apps usage and understand both users and non-users’ experiences and perceptions. The questionnaire was tested through cognitive debriefing, translated into Malay, pre-tested and finalized by the expert committee. The questionnaire was digitally implemented using Google® Form and QR code. After obtaining informed consent, data collection was performed by the trained DMTAC pharmacists. Statistical analyses involved descriptive and inferential analyses.ResultsThe study analyzed the engagement of 295 patients living with diabetes with mHealth apps. Females (54.9%), of Malay ethnicity (58.3%) and with a mean age of 53.8 years (SD: 12.38) constituted the majority. Diabetes duration had a median of 6 years (IQR: 3.0, 10.0) with prevalent comorbidities like hypertension (58.0%) and dyslipidemia (42.7%). Most patients were employed (44.7%) and their primary source of diabetes management information was through healthcare providers (92.5%). Despite the high app use for social interaction, only 13.6% used mHealth apps for disease management. Users were influenced by social media (65.0%) and favored for wellness apps and disease monitoring. Users perceived the mHealth app as useful (97.5%), yet faced challenges over the app initiation, charges and data security. Non-users cited lack of awareness (70.2%), struggled with app startup (22.4%) and preference for conventional healthcare visits (22.0%). In multivariable analysis, longer diabetes duration reduced mHealth app usage (p = 0.046), while multimorbidity increased the likelihood (p = 0.001). Awareness of the availability of health apps significantly influenced the usage of mHealth apps (p < 0.001).ConclusionThe findings highlight the underutilization of mHealth apps for diabetes management despite their perceived usefulness. Challenges faced by users and non-users underscore the need for more awareness, thus encourage widespread acceptance and usage of mHealth apps in diabetes care.

Medication refills do not guarantee medication intake: translation and validation of the adherence to refills and medications scale in traditional Chinese among individuals with type 2 diabetes in Taiwan

ABSTRACT Objective This study aimed to translate and validate the Adherence to Refills and Medications Scale into Traditional Chinese (ChARMS-T) and to investigate common barriers to medication adherence among patients with type 2 diabetes (T2D) in Taiwan. Methods The ChARMS-T was developed through translation and application phases. During the translation phase, the scale underwent forward translation, backward translation, and cognitive debriefing. In the application phase, the finalized ChARMS-T was administered to patients with T2D at five Taiwan community pharmacies over nine months starting in September 2023. Psychometric properties were assessed using criterion validity, construct validity through confirmatory factor analysis, and reliability through McDonald’s omega. Results A total of 343 participants completed surveys. Factor analysis of the 12-item ChARMS-T revealed two dimensions: medication-taking (8 items) and medication refill (4 items). The instrument demonstrated acceptable internal consistency, with McDonald’s omega scores of 0.841 for medication-taking and 0.647 for medication refill. The medication refill subscale showed strong agreement with the objective refill measure, proportion of days covered, with a coefficient of 0.84, suggesting that these measures evaluate similar constructs. Evidence of known-groups validity was demonstrated by a significant difference between ChARMS-T scores and glycemic control (p = 0.047). Patients with good glycemic control had a significantly higher adherence rate to both refills and medication-taking compared to those with poor glycemic control. The most frequently reported barriers to medication-taking were carelessness (55.7%), forgetfulness (54.8%), and frequent dosing intervals (43.1%). For medication refills, 9.6% of the participants identified a lack of planning as the main reason for not refilling their diabetes medications on time, followed by forgetfulness (7.6%). Conclusions The ChARMS-T identified a broader range of non-adherence reasons and demonstrated good psychometric properties. It can be integrated into practice settings for screening and follow-up to enhance medication adherence through effective communication between healthcare professionals and patients, ultimately improving long-term patient health outcomes.

The Portuguese version of the social activities checklist

ABSTRACT Introduction Social participation of people with aphasia (PWA) is a growing concern in healthcare. The impacts of aphasia in social participation are well known, but in Portugal, the number of assessment instruments that evaluate these difficulties is scarce. Objectives To translate and adapt the Social Activities Checklist (SOCACT) to European Portuguese (SOCACT-EP), analyse its validity (content and concurrent) and reliability (internal consistency and testretest) in a group of PWA and a group of neurologically healthy people (NHP). Methodology Cognitive debriefing of the translation process and content validation of SOCACT-EP were conducted by an expert panel of 5 PWA, both individually and in a focus group; SOCACT-EP was analysed qualitatively and quantitatively (Content Validity Index – CVI). The concurrent validity and reliability study involved a group of 15 PWA and 30 NHP. Results The SOCACT- EP version was considered by PWA as easy to understand and fill-in, and with an adequate length. Most questions obtained a maximum value of CVI. For PWA, Cronbach’s α in the Social Activities section was 0.660, and for NHP, it was 0.773. The test-retest results revealed good reliability. For the concurrent validity, significant correlations were found between SOCACT-EP and the Communication Disability Profile participation items. Some social activities differed significantly between the groups. No differences could be found for the “formal” dimension. Conclusions SOCACT-EP content is of great importance to PWA, and its psychometric characteristics are very similar to those of the original version in English. Revisions and adaptations are still needed to ensure that the instrument accurately assesses social participation of individuals with varying degrees of aphasia.

The spanish and catalan versions of the kidney patient reported experience measure (PREM) for chronic kidney disease (CKD): cultural adaptation and face validity

BackgroundChronic kidney disease (CKD) is a progressive condition affecting more than 800 million individuals worldwide. Patient Reported Experience Measures (PREMs) are questionnaires aimed at evaluating patients’ experiences with healthcare received. Given that CKD management often involves continuous treatments, capturing patient experiences can guide improvements in care that align with patients’ preferences, making PREMS a relevant tool in CKD management. The Kidney PREM questionnaire was developed in the United Kingdom to measure patient experience across entire service provisions in patients with chronic kidney disease (CKD). This study aimed to adapt the English version to Spanish and Catalan and assess the face validity of the new language versions.MethodsThe translation process was guided by the International Society of Pharmacoeconomics and Outcome Research (ISPOR) Principles of Good Practice for the Translation and Cultural Adaptation of Patient‑Reported Outcomes Measures and included forward and back translation, cognitive debriefing, and harmonisation between the Spanish and Catalan versions. Face validity was assessed in a sample of Spanish- and Catalan-speaking health professionals.ResultsIn the cognitive debriefing, 9 patients with CKD (4 in Catalan and 5 in Spanish) participated. Fourteen healthcare professionals (2 nurses and 12 nephrologists) assessed the face validity of the Catalan and Spanish versions. Overall, the language used in the original version of the questionnaire did not cause substantial problems for translation into Catalan or Spanish. Patients generally found the questionnaire to be relevant and relatively easy to complete but reported some difficulties with questionnaire design, including the use of ‘skip’ questions. Clinicians and nurses highly rated the questionnaire in terms of relevance (mean score of 8.7 on a 0–10 scale) and acceptability, indicating good face validity, but considered some elements to be lacking, such as the absence of an open-ended question or any queries regarding lifestyle.ConclusionsIt was feasible to produce culturally adapted Spanish and Catalan versions of the Kidney PREM questionnaire, and they showed acceptable face validity. They will be useful tools for furthering research and clinical practice in CKD patients in Spain.

Relevance of patient-centered actigraphy measures in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: a qualitative interview study

BackgroundPulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are severe, progressive diseases characterized by key symptoms such as dyspnea and fatigue. These symptoms impair physical functioning, with patients struggling to perform their daily activities. One traditional measure of physical functioning and exercise capacity is the 6-minute walk test (6MWT). Actigraphy represents a promising tool to complement the 6MWT and provide a holistic picture of physical performance in patients with PAH or CTEPH. However, the current literature holds limited evidence on content validity of actigraphy in these populations, as reported by patients themselves. The primary objective of this study was to understand which physical functioning concepts are most meaningful to patients with PAH or CTEPH and identify relevant actigraphy variables and appropriate timeframes for their measurement.MethodsThis was a cross-sectional, qualitative study in adults with a confirmed diagnosis of PAH or CTEPH. Participants from the UK and USA were interviewed one-on-one via a web-based platform, with interviewers using a semi-structured discussion guide that included concept elicitation and cognitive debriefing sections. Data within the anonymized interview transcripts were coded and thematically analyzed.ResultsConcept elicitation identified the physical functioning concepts most meaningful to patients with PAH or CTEPH and generated a combined conceptual model of physical functioning, which strongly aligned with previous literature. During cognitive debriefing, of the four actigraphy variables debriefed in relation to these physical functioning concepts, study participants highly valued time spent in non-sedentary physical activity and time spent in moderate to vigorous activity, while step count and walking speed emerged as less relevant. Participants indicated four alternative variables as relevant: walking distance, walking up hills or inclines, duration of continuous walking bouts, and time spent walking. Regardless of the variable, participants suggested a timeframe of approximately 10 or 12 h/day over a minimum of 14 days for measuring physical functioning.ConclusionsBy demonstrating the content validity of actigraphy measures of physical functioning, this qualitative study begins to address the evidence gaps identified by the regulatory requirements for using actigraphy endpoints in future PAH and CTEPH clinical trials.

The Mastocytosis Control Test: A Patient-Reported Outcome Measure Assessing Disease Control

BACKGROUNDMastocytosis is characterized by expanding neoplastic mast cells in organs such as the skin, bone marrow, and gastrointestinal tract. The release of mast cell mediators triggers cutaneous, gastrointestinal, and other symptoms. Currently, no validated mastocytosis-specific patient-reported outcome measure (PROM) exists to assess disease control. OBJECTIVEHere, we developed a disease-specific instrument, the Mastocytosis Control Test (MCT), for evaluating and monitoring disease control in patients with non-advanced disease. METHODSSix potential MCT items were generated using a combined approach consisting of a literature review, patient interviews, and expert input. Item selection and reduction were performed by impact analysis and inter-item correlation, followed by expert reviews and cognitive debriefings. In a validation study, the resulting MCT was tested for validity and reliability by assessing internal consistency, test-retest reliability, convergent validity, known-groups validity, and receiver operating characteristics (ROC) analysis. RESULTSTen patients participated in the item generation phase and 101 in the item reduction and validation phase. The final MCT consisted of five items. Our methods showed a valid total score, high internal consistency, and test-retest reliability. Convergent and known-groups validity demonstrated a strong correlation with related anchors. The ROC curve analysis suggested a cutoff value of ≥13 points to identify patients with good disease control. CONCLUSIONSThe MCT is a disease-specific, valid, and reliable PROM for adult patients with non-advanced disease. It may measure and monitor disease control in routine daily practice and clinical trials.

Development of a questionnaire to measure patient-relevant needs and benefits in the treatment of epilepsy (PBI-Epilepsy)

ObjectiveTherapeutic goals in epilepsy treatment may be highly individual. The aim of the present study was to develop a questionnaire assessing patients’ needs and benefits of epilepsy treatment, the Patient Benefit Index on Epilepsy (PBI-Epilepsy). MethodsWe recruited adult patients during their stay at a university based epilepsy centre. Patients completed a survey asking about their burden and treatment goals. Data were categorised using qualitative content analysis. The final category system was discussed in an expert panel. The questionnaire was pre-tested using cognitive debriefing and adapted until no changes were required anymore. ResultsIn the open survey, 25 people with epilepsy participated (60.0 % female, 33.2 years, 1–55 years epilepsy). The final category system included nine main categories (namely psyche, working life, seizures, therapy, leisure activities, social relationships, mobility, body, everyday life activities). From this, the expert panel developed a first draft of the PBI-Epilepsy. The questionnaire went through five rounds of cognitive debriefing with 29 patients (51.7 % female, 34.6 years, 2–37 years epilepsy). We decided to develop two versions of the questionnaire depending on the patient’s treatment (medical or surgical). A bipolar response scale was used in the part asking about treatment benefits, as epilepsy treatment can lead to both improvement and deterioration. The final questionnaire consists of two parts (patient needs and treatment benefits) each encompassing 21 items. ConclusionWe aimed to reflect the wide range of issues that are relevant for people with epilepsy while developing a questionnaire that is short and easy for patients to understand.

Nutrition Knowledge and Food Literacy Among Persons with Multiple Sclerosis-Development and Validation of Patient-Reported Outcome Measures.

Persons with MS (pwMSs) are often confronted with contradictory dietary advice, which is not always based on sound scientific evidence. This may lead to poor MS-specific nutrition knowledge (MSNK) and food literacy (MSFL). To date, no studies have assessed MSNK and MSFL among pwMSs. Moreover, no validated tools to measure the effects of educational interventions are available. The aim of this study was to develop and validate MS-specific instruments to measure MSNK and MSFL among pwMSs. Based on a validated food literacy (FL) screener for the general population and prior research about the information needs of pwMSs, we developed 14 MSFL items and 11 MS-specific nutrition knowledge questions. Cognitive debriefing was conducted with 10 pwMSs and resulted in a 12-item MS food literacy questionnaire (MSFLQ) and an 11-item MS nutrition knowledge questionnaire (MSNKQ). After refinement, both questionnaires were pilot tested in an online survey to explore their comprehensibility. The MSNKQ was analyzed descriptively (mean and percentage of correctly answered questions). For MSFLQ item difficulty, the discriminatory power of the items, internal consistency and convergent/divergent validity were assessed. In total, 148 pwMSs (age: 47.1 years (SD = 12.5); 102 women (69%)) completed the online survey. On average, participants answered 3.51/11 MSNK questions correctly (31.9%). The MSFLQ showed good internal consistency (Cronbach's alpha = 0.85), item difficulty was good and the discriminatory power of the items was satisfactory. Correlations between the MSFLQ and a general food literacy questionnaire was high (r = 0.626, p < 0.001), but only small with the MSNKQ (r = 0.180; p = 0.029), underlining the different constructs. MSNK among pwMSs in Germany is low. The MSNKQ and MSFLQ appear to be suitable instruments to assess MSNK and MSFL and might serve as outcome measures for educational interventions.

Wolastoqiyik adaptation of the Aaniish Naa Gegii: the Children's Health and Well-Being Measure.

Indigenous children in Canada represent one of the fastest-growing pediatric populations and experience severe health inequities. There is an ongoing need for new research on relevant methods to measure the health and wellbeing of Indigenous children that considers the cultural differences between communities. The Aaniish Naa Gegii: the Children's Health and Well-Being Measure (ACHWM) is a self-reported questionnaire that was developed to meet this need and to include the voices of Indigenous children. The purpose of this study was to assess the cultural relevance of the ACHWM for Wolastoqiyik children and to determine what revisions may be needed to ensure that the questions are well understood and culturally appropriate. We recruited a community-based sample of nine Wolastoqiyik children (ages 8 to 16 years), two caregivers, and a community Elder within the Madawaska Maliseet First Nation community in New Brunswick. Through a process of cognitive debriefing, we probed children's comprehension of the 62 questions of the First Nation French version of the ACHWM. We analyzed the information reported to determine the participants' understandings relative to the other participants and to the original intent of the ACHWM content. Each of the nine children identified at least one item they recommended for revision during the interview. We observed similarities in the suggestions offered by several respondents. A total of 23 questions were considered, and 14 questions (22.6%) were modified, taking into consideration all participants' suggestions. While measures like the ACHWM offer useful information, relying solely on a 'one size fits all' Indigenous questionnaire is insufficient. Our findings underline the importance of having methods that are easily accessible, adaptable, and culturally appropriate for assessing and addressing Indigenous children's unique health and wellbeing. Such information allows clinicians to develop interventions that are culturally relevant, addressing children's individual needs within the context of their distinct cultural identity.

Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS).

Chronic Hand Eczema (CHE) is an inflammatory skin disease that causes significant impact on health-related quality of life (HRQoL). The Hand Eczema Impact Scale (HEIS) is a new patient-reported outcome(PRO) measure designed to assess the impact of CHE on key domains of HRQoL. This study aimed to develop and evaluate content and psychometric validity of the HEIS. The HEIS was initially developed on the basis of a literature review and concept elicitation interviews. Qualitative cognitive debriefing interviews (n = 20) were conducted with patients with CHE to assess relevance and understanding of items, response options, and recall period. Psychometric properties (item performance, dimensionality, reliability, validity, responsiveness, and estimation of meaningful change thresholds) were then assessed using data (n = 258) from a phase 2b trial (NCT03683719). Cognitive debriefing confirmed all items were understood and relevant to patients. Inter-item correlations (all > 0.50) and confirmatory factor analysis (factor loadings ≥ 0.80) supported unidimensionality of the HEIS score, and mostly provided support for the HEIS Proximal Daily Activity Limitations (PDAL) score, with only one item loading below the prespecified threshold. Item properties and previous qualitative work supported retaining this item in the total score but removed from the HEIS PDAL domain. Internal consistency (Cronbach's alpha ≥ 0.89) and test-retest reliability (intra-class correlation coefficient ≥ 0.79) results were very strong. Strong correlations with concurrent measures (0.66-0.87) and significant differences between severity groups (p < 0.001) supported construct validity. Large effect sizes for mean change scores in participants that improved and significant differences between groups indicated ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 1.3 points for improvements in both HEIS score and HEIS PDAL score (covering three items) and of ≥ 1.5 points for HEIS embarrassment with the appearance of hands (Emb) score (covering two items). The 9-item HEIS is the first CHE-specific PROmeasure developed and validated according to regulatory guidance for assessment of the impact of CHE on key domains of HRQoL. This article provides evidence of strong content and psychometric validity and shows improvements of ≥ 1.3 points in HEIS score and HEIS PDAL score, and improvements of ≥ 1.5 points in HEIS Emb score represent clinically meaningful, important changes. NCT03683719.

Linguistic Validation of the Functional Assessment of Chronic Illness Therapy-Spiritual-Well-being-Expanded Version 4 Tool into Malayalam Language and its Feasibility in Advanced Cancer Patients Receiving Palliative Care.

The objective of this study was to validate the 'Functional Assessment of Chronic Illness Therapy-Spiritual-Well-being-Expanded(FACIT-SpEx) Version 4' tool in Malayalam and assess its feasibility among advanced cancer patients receiving palliative care. The study was carried out at the outpatient Department of Cancer Palliative Medicine of Malabar Cancer Centre between November 2022 and June 2023. Initially, the FACIT-Sp-Ex version 4 tool with 23 items was translated into the Malayalam language with a forward-backward translation procedure. This was followed by pilot testing in 10 advanced adult cancer patients receiving palliative care who could read and comprehend the Malayalam language. After answering the draft version of the validated tool, patients responded to questions from a Malayalam-translated cognitive debriefing script. The process of translation and cross-cultural adaptation went on smoothly with very few hurdles. The Malayalam terms used in three items Sp7, Sp9 and Sp23 when back translated were found to be different from the source. These issues were resolved with the use of the most suitable translations and closest equivalents available in Malayalam. In the pilot testing, the majority (70%) of the patients were female. The mean age of patients was 45.90 (standard deviation [SD] = 7.62) years. Carcinoma breast (50%) was the most common type of cancer. All the patients knew their diagnosis, while only 80% knew the prognosis. Almost 90% of the patients were receiving some form of palliative anticancer treatment. All patients completed the draft version of the validated tool. The mean spiritual well-being score measured using this validated tool was 71.20 (SD = 15.10). Analysis of the debriefing interviews revealed that the Malayalam version was easy to complete, relevant, and appropriate. Linguistic validation and cognitive debriefing produced the Malayalam translated FACIT-Sp-Ex version 4 tool conceptually equivalent to the original FACIT-Sp-Ex version 4 tool, and it is feasible for its use.

The Arabic medication-related burden quality of life (MRB-QoL) tool: Cross-cultural adaptation and content validation

BackgroundThe Medication-Related Burden Quality of Life (MRB-QoL) is a 31-item valid and reliable patient-reported measure of medicine burden on functioning and well-being in people with long-term conditions (LTC). ObjectivesTo translate, culturally adapt, and content validate the MRB-QoL into Arabic. MethodsA rigorous approach to cross-cultural adaptation proposed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guideline was followed. After 3 forward translations and 2 backward translations, a multidisciplinary expert panel assessed the content validity (CV) of the items through a 2-round e-modified Delphi method followed by two-step cognitive debriefings with patients with LTC using think-aloud and probing techniques. An item-content validity index (I-CVI) score of ≥0.78 was considered acceptable. The original questionnaire developers and other researchers, as members of the review committee, reviewed and approved the Arabic version. ResultsFive semantic and 3 cultural translation discrepancies were identified and resolved by rewording the items. The 2 backward translations did not reveal significant problems, and equivalence to the original tool was confirmed following committee review. The Arabic version showed acceptable CV parameters. E-modified Delphi involved 9 experts in round one and 7 in round 2. The I-CVI scores ranged from 0.67 to 1.0, and agreement was reached after 2 rounds. The CVI for the final version of the MRB-QoL was 0.96. Expert panel review showed that the MRB-QoL-Arabic version is relevant (CVI = 0.92), important (CVI = 0.97), clear (CVI = 0.98), and comprehensive in measuring the burden of medicines. Data from 5 cognitive interviews showed that items and concepts included in the Arabic version of the MRB-QoL are relevant to the targeted sample, clear, and easy to understand. ConclusionThe MRB-QoL Arabic version was developed and content validated. However, further evaluation of its other psychometric properties is necessary before it can be utilized in clinical and research settings. Using this tool will enable a more accurate understanding of the effects of treatment burden on patient well-being, thereby guiding care toward minimally disruptive medicine.

Development and validation of the Child Hemophilia Treatment Experience Measure: A new observer-reported outcome measure.

The Child Hemophilia Treatment Experience Measure (Child Hemo-TEM) was developed to capture the treatment burden experience of children with haemophilia (CwH). Describe the development of this novel haemophilia-specific measure. Interviews were conducted with clinical experts, CwH and CwH's caregivers. Interviews were analysed according to adapted grounded theory principles. Based on the analysis, a preliminary measure was developed and debriefed. Psychometric analyses were performed according to an a priori analysis plan using data collected in a cross-sectional web survey and a final measure was generated. Interviews with four clinical experts, 25 CwH ages 8 to <12 years, and 25 caregivers of CwH <12 years were conducted. Concepts endorsed by ≥10% of CwH and caregivers were: adherence, ease of use, emotional impacts, physical impacts, treatment concerns, and interference with daily life. Cognitive debriefing assessments were conducted to ensure participant understanding and item relevance. Caregivers found the measure to be understandable, comprehensive, and relevant. However, several issues with CwH completing the measure were identified and it was decided to only develop an observer-reported outcome version. Data for psychometric validation was collected in a web survey (N=187). Item reduction dropped 12 items. Factor analysis generated a single, 7-item, internally consistent (α =.855) factor, which consisted of items covering all relevant a priori concepts. The majority of a priori convergent and all known groups validity hypotheses were confirmed. The study findings provide evidence that the Child Hemo-TEM is a brief, well-designed, and valid and reliable measure of haemophilia treatment burden.