Development and Content Validity of Cervicogenic Headache Patient Questionnaire: New Tool for Assessing Severity and Impact.

BACKGROUND AND AIM: Cervicogenic headache (CGH) is a complicated and common headache disorder that may present itself with cervical spine dysfunction, irritation of the nerves, central sensitization, and muscular tension. Theoretically, this diagnosis should be an exclusionary diagnosis, considering the fact that it requires extended clinical assessment of the cervical spine and an evaluation for other primary headache types. CGH represents a clinical challenge as they habitually present with an array of nonspecific manifestations highly variable among patients. Management of CGHs is properly based on accurate diagnosis and sound understanding of the complaints of the individual. The development of CGH still carries with it a palpable gap in meaningful literature related to really effective assessment tools for the condition. The aim of the current study was to develop and investigate the validity of the content of the Cervicogenic Headache Patient Questionnaire. This questionnaire is designed especially to measure pain intensity, its impact on daily activities, disturbance in sleep, and the overall quality of life in subjects with CGHs. METHODOLOGY AND RESULTS: The content validity ratio (CVR) and Content Validity Index (CVI) have been used to thoroughly examine the content validity. Each item was rated by 10 experts for relevance and clarity. The scale consists of two main parts: demographic information and symptoms. Under the demographic section, the patient is asked for their age, sex, occupation, and any relevant medical history. The Symptom Checklist contains 10 questions concerning headache frequency, intensity, duration, location, and contributing factors, as well as how headaches affect daily activities, sleep, and quality of life. Item-CVI scores ranged from 0.60 to 1.00, and Scale-CVI/Ave was 0.95, which indicates strong overall content validity. The Scale-CVI/Universal Agreement was 0.83, meaning that most items are of high relevance. The clarity assessments resulted in I-CVI ratings of 1.00 for the majority of items. Using CVR analysis, items 1, 2, 5, 6, 7, and 10 all had a CVR of 1.00, whereas all the rest ranged from 0.40 to 0.80, suggesting unanimous agreement among the experts. CONCLUSION: The results underline the strength of the questionnaire in covering all the critical dimensions of cervicogenic headaches, such as pain, daily functioning, sleep, and quality of life. The scores provided by experts for content validity and clarity were high; hence, it is suitable for use as a comprehensive tool both in clinical and research applications.

The Pain Descriptors Used by Individuals with Musculoskeletal Pain from Northern India.

Background: Chronic pain is a common health problem worldwide that results in significant costs to society and has negative impacts on the individuals with chronic pain. In order to study and treat pain, valid and reliable pain assessment is necessary, including assessment of pain quality. However, all of the most commonly used measures of pain quality were developed in Western countries. Evidence has shown that some of these measures are not content valid for use in non-Western countries. Moreover, it remains unclear which pain descriptors are universal across people from different countries who speak different languages, and which are specific to individuals from a particular country or even from a particular region within one country. Aim: The current study sought to: (1) identify the number and frequency of words used by native speakers of Hindi in northern India to describe their pain; (2) compare the rates of descriptor use in these individuals with samples of individuals from Nepal and the USA; and (3) investigate the content validity of the most commonly used pain quality measures for measuring pain in this Hindi-speaking population. Methods: Two hundred and forty individuals with chronic musculoskeletal pain who speak and understand Hindi were asked to describe their pain. Results: The results showed overlap as well as differences in the words used to describe pain with samples of individuals with pain from other countries. Moreover, none of the pain quality measures examined were found to be content valid in the Hindi-speaking sample, suggesting that these measures need to be adapted to assess pain quality in this population. Conclusion: The study findings confirm the conclusion that pain quality measures developed in one country or in one pain population are not necessarily valid for assessing pain quality in a population from another country. The findings also suggest the possibility that a measure could be developed which would allow for more valid assessment of pain quality in individuals with pain from different countries.

The Development and Content Validation of the Sjögren's Related Quality of Life Instrument (SRQoL).

INTRODUCTION: Several clinical outcome assessment (COA) instruments assess Sjögren's disease (Sjögren's) symptoms, but do not provide comprehensive assessment of the health-related quality of life (HRQoL) impact of Sjögren's. This study aimed to develop a patient-reported outcome (PRO) instrument for the assessment of HRQoL, intended for use in clinical trials and clinical practice in the assessment of treatment benefit. METHODS: Review of study sponsor proprietary data and qualitative interviews informed the development of a conceptual model, the Sjögren's Related Quality of Life (SRQoL) and patient global impression of severity (PGI-S) and change (PGI-C) items. Combined concept elicitation and cognitive debriefing interviews with patients with Sjögren's explored their HRQoL impact experience and content validity of the SRQoL and PGI items. RESULTS: Twenty participants were interviewed about their Sjögren's experience. Following inductive analysis of interviews, concepts were categorized into eight domains: emotional well-being (e.g., worry and stress; n = 20/20; 100%), sleep (e.g., daytime sleepiness and waking up during the night; n = 20/20; 100%), activities of daily living (e.g., difficulty looking at screens and difficulty driving; n = 20/20; 100%), cognition (e.g., concentration difficulties and word finding difficulties; n = 19/20; 95.0%), physical functioning (e.g., difficulty walking and difficulty exercising; n = 19/20; 95.0%), social and family functioning (e.g., dependent on others and relationship difficulties; n = 17/20; 85.0%), work (n = 15/20; 75.0%), and sexual functioning (n = 12/20; 60.0%). SRQoL and PGI items, instructions, response options, and recall period were well understood and relevant to participants. CONCLUSIONS: The SRQoL is a new PRO instrument to assess Sjögren's impact on HRQoL, developed in accordance with regulatory guidance. This study provides considerable insight into the patient experience of Sjögren's and evidence to support the content validity of the SRQoL. Future research should evaluate the psychometric properties of the SRQoL to support its use in clinical trials and clinical practice and further validate its use as an assessment of treatment benefit.

Patient and physician completed questionnaires used in clinical trials and clinical practice have previously focused on symptoms. These questionnaires do not cover the full experience of living with Sjögren's, such as differences in symptoms between individual patients, and their use has also been known to result in inaccurate reports. Another way of thinking about patients' experiences is to use a questionnaire to ask about the impact Sjögren's has on patients' health-related quality of life, meaning how Sjögren's might affect their life in different ways including physically, emotionally, and socially. The goal of this study was to develop a new questionnaire (named the Sjögren's-Related Quality of Life [SRQoL] questionnaire) to measure the impact that Sjögren's has on patients' lives. Interviews were conducted with people with Sjögren's to explore their understanding of the new questionnaire and how relevant the content is to their experience of the condition. The results of this study suggest that the SRQoL includes relevant and easy-to-understand questions, suitable for use in future clinical trials and clinical practice, to measure if patients' HRQoL improves with treatment. Future research is needed to confirm that the questionnaire accurately measures the impact of Sjögren's on HRQoL for use with patients with Sjögren's.

Adapting and Validating a Patient Prompt List to Assist Localized Prostate Cancer Patients with Treatment Decision Making.

BACKGROUND/OBJECTIVES: Effective communication between patients and healthcare providers is essential for informed decision making in cancer care. Communication aids that can help prostate cancer patients optimize their involvement in treatment care planning are not widely used in the U.S. This research details the adaptation and validation process of a patient prompt list for localized prostate cancer patients undergoing treatment decisions. METHODS: This process occurred in three steps: Step 1 involved gathering usable questions from the literature; in Step 2, we evaluated the tool's content via expert (N = 6) feedback; and in Step 3, we assessed the usefulness of the prompt list with patients (N = 30). RESULTS: Sixty percent of candidate questions (20/33) were retained for inclusion after achieving acceptable item-level content validity index (range: 0.83-1.00) and scale-level content validity index (S-CVI = 0.96) scores. The final 20 questions were classified into 5 domains (1: Treatment Options and Information, 2: Side Effects, Risks, and Recovery, 3: Emotional and Social Support, 4: Logistical and Practical Concerns, and 5: Future Health Considerations) through a card sorting exercise with a subset of patients (N = 3) and providers (N = 2). Most patients rated the prompt list as "useful or very useful" both to themselves (80%, N = 24) and to other men presenting with prostate cancer (83%, N = 25). CONCLUSIONS: The participatory process used to develop and validate the prompt list offers insights for the development of similar tools.

Cultural translation of the ethical dimension: a study on the reliability and validity of the Chinese nurses' professional ethical dilemma scale.

BACKGROUND: Quantifying the professional ethical challenges that nurses encounter is crucial for both theoretical insights and practical outcomes. The objective of this research is to assess the psychometric properties of the Chinese adaptation of the Moral Distress Scale for Healthcare Professionals (MD-APPS). METHODS: In 2024, a survey approach was utilized to engage with several tertiary-level healthcare institutions throughout China. A cohort of 448 nursing professionals who satisfied the specified selection benchmarks was consequently incorporated into the study. To evaluate the scale's reliability and validity, methods including the Content Validity Index (CVI), Factor Analysis-both Exploratory (EFA) and Confirmatory (CFA)-alongside assessments of internal consistency and test-retest reliability were employed. RESULTS: Expert evaluations yielded an I-CVI of 0.90, suggesting good content validity for the MD-APPS's Chinese adaptation. Exploratory Factor Analysis (EFA) revealed a bi-dimensional framework with 7 components, explaining 56.34% of the cumulative variance. Confirmatory Factor Analysis (CFA) outcomes displayed a χ-square/df ratio of 1.542. The estimate for Robust RMSEA was 0.054, and the SRMR was ascertained to be 0.041. Indices for both Robust TLI and Robust CFI surpassed the 0.9 threshold, indicating an acceptable fit; this aspect was supported by a P-value (Chi-square) of 0.094. The internal consistency, measured by Cronbach's α, was found to be 0.74, while the test-retest reliability over a two-week period reached 0.964. These findings provide initial evidence for the psychometric properties of the Chinese MD-APPS. CONCLUSION: The Chinese adaptation of the MD-APPS demonstrates promising initial psychometric properties, suggesting its potential suitability for exploring nurses' professional ethical challenges within the Chinese cultural context. This scale may facilitate the identification of diverse elements influencing nurses' professional ethics and the assessment of the ethical climate in nursing practices. However, further validation studies are needed to fully establish its psychometric robustness across various healthcare settings in China.

Impact of rehabilitation with dental implants on the quality of life of patients undergoing maxillofacial reconstruction: a systematic review.

PURPOSE: Maxillofacial reconstruction with dental implants in microvascular tissue flaps aims to improve mastication. However, the quality of life (QoL) impact of this intervention is yet to be determined. This systematic review assessed the QoL impact of maxillofacial reconstruction with implant-supported teeth compared to no dental rehabilitation, removable dentures, and obturator (modified denture). Additionally, we examined instruments applied to measure QoL in maxillofacial reconstruction. METHODS: Databases Ovid Medline and Embase, Scopus, Web of Science and Handle on QoL were searched. Cohort, case-control and randomized controlled trials (RCT) were narratively synthesized for QoL captured through validated instruments. Study methodological quality was assessed using Cochrane Risk of Bias 2 and Risk of Bias in Non-randomized studies of Exposure. Instruments underwent COSMIN content validity analysis. RESULTS: Of a total of 2735 studies screened, the three included studies (two cohort and one RCT) showed improved QoL with maxillofacial reconstruction compared to obturator and no dental rehabilitation. However, these studies have high risk of bias due to confounding. None of the instruments achieved a sufficient relevance rating for maxillofacial reconstruction, having been designed for other target populations and there is no evidence on their content validity for this population, but the EORTC QLQ30 H&N35 satisfied more COSMIN criteria than the UW-QOL and OHIP-14. CONCLUSION: Although studies showed favourable QoL with maxillofacial reconstruction involving dental implants, these have high risk of bias and further studies are needed to establish the impact. Existing QoL instruments lack content validity and tailored instruments are needed for QoL evaluation in maxillofacial reconstruction.

The Evaluation of Content Relevance and Representativeness of the New Stroke Risk Screening Scales.

Stroke is a leading cause of death and disability worldwide. Early and comprehensive risk identification is essential for identifying individuals at high risk for stroke. This study aimed to evaluate each question in the new Stroke Risk Screening Scales (SRSS) and assess the domains for content relevance and representativeness. Initially, six stroke experts were invited to evaluate the SRSS questions. The content validity index (CVI), including the item-CVI (I-CVI) and the average-CVI (Ave-CVI), was then calculated. In our study, the acceptable standards for I-CVI and Ave-CVI were ≥0.78 and ≥0.9, respectively. The results showed that all invited experts accepted the invitation and evaluated the SRSS questions. The previous version of the SRSS consisted of 33 questions. Of these, 30 questions reached an I-CVI of ≥0.78, indicating good content validity. Three questions had an I-CVI of 0.67 and were considered invalid; thus, they were deleted. The overall instrument achieved an Ave-CVI of 0.95. Comprehensive SRSS are essential for effective stroke prevention planning. By facilitating the early identification of individuals at high risk for stroke, these scales help reduce the incidence and impact of stroke. The high content validity found in this study supports the reliability of the SRSS as a screening tool. In the future, implementing such validated scales in clinical practice can improve early intervention strategies, ultimately enhancing health outcomes and optimizing the use of healthcare resources.

Development and Validation of an Interprofessional Community-Based Teaching-Learning Module for a Family Adoption Programme for Indian Medical Undergraduates.

INTRODUCTION: Medical education aims to prepare graduates to address society's health requirements effectively. The majority of assessments are summative and provide a minimal chance for feedback. The evaluation techniques and teaching-learning activities place a greater emphasis on knowledge than on attitude and abilities. They might also lack soft skills, including professionalism, ethics, doctor-patient relationships, and communication, as they are a hidden part of the traditional curriculum. Learning activities that take place in a specific setting, like a community, are referred to as community-based education. OBJECTIVES: To develop and validate the Interprofessional Teaching-Learning Module for the Family Adoption Program for medical undergraduates.  Method: This was an educational observational study to develop a module for a family adoption program for Bachelor of Medicine and Bachelor of Surgery (MBBS) students, which began from the first professional year and extended to the second and third professional years. Experts from different health professions were identified, and a preliminary meeting was called to discuss the purpose of the module and the role and responsibilities of each. Institutional Ethics Committee clearance was obtained after the submission of the synopsis. RESULTS: An interprofessional team was formed and communicated regarding the purpose of the module, and the initial draft was prepared with their contribution. The panel of experts for relevancy validated the module, and the content validity index derived, which was 0.92, was considered good and relevant. CONCLUSION: The Interprofessional Teaching-Learning Module for the Family Adoption Program is a comprehensive and collaborative approach for equipping students' necessary knowledge and skills to facilitate successful adoption and support families effectively.

Cross-cultural adaptation of the empowerment scale of pregnant women in China context: An integrative method of translation and linguistic validation.

AIM: To translate the Empowerment Scale for Pregnant Women (ESPW) into Chinese and to assess its linguistic validity. METHODS: The integrative method of the translation process, the Delphi technique, and cognitive interviews were used to implement cross-cultural adaptation and enhance comprehensibility and linguistic validation. This study recruited 14 experts in the expert review and cognitively reviewed 15 pregnant women. RESULTS: The two-round Delphi method created agreement on cultural applicability. The results of content validity achieved good levels: The item-level content validity index (CVI) ranged from 0.78 to 1.00, and the scale-level content validity index, calculated using two different formulas, were 0.97 and 0.81, respectively. Kappa values ranged from 0.74 to 1.00. Pregnant women could understand most of the items and response options in the cognitive interview. The revisions to the wording were made based on suggestions from experts and pregnant women. CONCLUSION: The prefinal simplified Chinese ESPW was semantically and conceptually equivalent to the English version, which was well prepared for further psychometric tests in the next stage of cross-cultural adaptation. PATIENT OR PUBLIC CONTRIBUTION: This comprehensive method successfully developed a Chinese tool to measure the empowerment of pregnant women, indicating the international applicability of this tool and the methodological scientific nature. The simplified Chinese ESPW has the potential to support the identification of empowerment levels of pregnant women and the evaluation of the effectiveness of health education and promotion programmes.

Content validity of the Leicester Cough Questionnaire in adults with refractory or unexplained chronic cough: a qualitative interview study.

BACKGROUND: Chronic cough, a cough lasting >8 weeks, includes refractory chronic cough (RCC) and unexplained chronic cough (UCC). Patient-reported outcome (PRO) measures are needed to better understand chronic cough impacts that matter most to patients. The 19-item Leicester Cough Questionnaire (LCQ), an existing PRO measure of chronic cough, assesses impacts of cough across physical, psychological, and social domains. However, the content validity of the LCQ evaluating these concepts in patients with RCC/UCC had not been established. OBJECTIVES: To evaluate the content validity of the LCQ in patients with RCC/UCC. DESIGN: A cross-sectional, qualitative interview study. METHODS: First, previously completed qualitative interview results in adults with RCC/UCC (N = 30) were evaluated and mapped to LCQ concepts. Next, a clinical cough expert reviewed each LCQ item and assessed the salience of its concepts for patients with RCC/UCC. Finally, semistructured interviews-including both concept elicitation and cognitive debriefing-were conducted in adults with RCC/UCC (N = 20) to elicit a comprehensive set of participant experiences and to assess the appropriateness of using the LCQ in this population. RESULTS: Concepts reported in the past and present qualitative interviews were included across all LCQ items, and most impacts reported to be the "most bothersome" were assessed in the LCQ. In the current study, all participants indicated that reduced cough frequency would be an important treatment target. During cognitive debriefing, each LCQ item was endorsed by ⩾70% of participants. Additionally, participants were generally able to understand, recall, and select a response for each LCQ item. All participants and the clinical expert indicated that the LCQ was appropriate and assessed the impacts most relevant to patients with RCC/UCC. CONCLUSION: Our findings support the content validity of the LCQ and demonstrate that this measure is fit-for-purpose and includes important cough impacts in adults with RCC/UCC.

Development of self-administered questionnaire on barriers, prescription practices, and guideline adherence of osteoporosis management among tertiary care clinicians: content validity and reliability analysis.

Objective: This study outlined the development of the barriers, prescribing practices, and guideline adherence for osteoporosis management according to the Clinicians' Osteoporosis Questionnaire (COQ) followed by an assessment of the content validity index and reliability test. Methods: The development of the COQ was performed in two stages. Stage I involved the development of the COQ, and stage II involved judgmental evidence and quantification of the questionnaire. Five panel experts related to the study area and five clinicians participated in the validity of the COQ assessment. Fifty clinicians took part in the reliability test evaluation by filling out the questionnaire twice at 2-week intervals. The content validity index (CVI) and content validity ratio (CVR) were analyzed using Microsoft Excel, while Cohen's kappa statistic was used to determine the test-retest reliability using SPSS version 29. Results: Forty items and three domains, namely, barriers, prescribing practices, and guideline adherence for osteoporosis management, were identified in the COQ (version 4.0). The scale-level CVI (S-CVI/Ave) for every domain was above 0.9, which is considered acceptable. The CVRs for all the items were above 0.7, except for two items in the barrier domain and two items in the guideline adherence domain. Two items were revised to improve the clarity of the item, and other items were retained based on consensus among the expert panel. Between the test and retest, the reliability of individual items ranged from moderate to almost perfect for the barrier domain (k = 0.42-0.86), prescribing practice domain (k = 0.79-0.87), and guideline adherence domain (k = 0.46-1). None of the items had "fair" or "poor" agreement. Thus, the 40-item COQ (version 4.0) was finalized following the content and face validity analysis. Conclusions: Through an iterative process, the development and assessment of the COQ showed a high degree of content validity and reliability in measuring the barriers, prescribing practices, and guideline adherence among clinicians managing osteoporosis. Future studies should aim to further validate this instrument across different populations and settings, as well as explore methods to enhance its reliability and validity.

Cognitive interviewing validation of the Chinese version of the neurogenic bladder symptom score.

Background: The neurogenic bladder symptom score (NBSS) has been widely used to specifically measure symptoms and consequences of neurogenic bladder (NB). The cognitive interviewing (CI) is effective in assessing item clarity and identifying key issues related to the comprehension of the instrument. We aim to translate the NBSS into Chinese and use the CI approach to explore the thought processes of patients with NB in responding the Chinese Version of the NBSS, identify and modify the factors hinder the thought processes to enhance the face validity of the NBSS. Methods: The translation of the NBSS into Chinese was conducted with the guidance of the recommended frameworks. Patients with NB were recruited by purpose sampling. CI with the combination of thinking aloud and verbal probing techniques were used to explore thought processes. The interviews were transcribed and analyzed based on Tourangeau four-stage response model. Results: Two rounds of CI were carried out. The problems of comprehension, judgement and response mapping were identified in 8 items. Four items were revised based on the results of the interview. The revised items were verified and eventually integrated into the final version. Conclusion: The Chinese Version of the NBSS was easy to comprehend and use. The use of CI methodologies can increase the comprehensibility and cultural applicability of the NBSS, providing the evidence for the development of a clearer and more appropriate questionnaire.

Evaluating depression in Indonesian adolescents with epilepsy: Comprehensive validation and reliability assessment of the neurological disorders depression inventory-epilepsy for youth Indonesian version (NDDI-E-Y[ID]).

OBJECTIVES: Epilepsy is a common chronic neurological disorder in pediatrics. Depression is an often underdetected comorbidity in childhood epilepsy. This study aimed to adapt the Neurological Disorders Depression Inventory-Epilepsy for Youth (NDDI-E-Y) to the Indonesian language and population, as well as to validate the Indonesian version of NDDI-E-Y (NDDI-E-Y[ID]). METHODS: This three-stage study comprised instrument translation, cultural verification, and content validity testing (first stage), pilot testing (second stage), followed by concurrent validity and reliability testing (third stage) of the NDDI-E-Y(ID). Validation was done against the Centre for Epidemiologic Studies Depression Scale - Revised (CESD-R). Content validity, assessed by six experts, was quantified using the content validity index for items (I-CVI) and scale (S-CVI). Participants were adolescents aged 12-17 years diagnosed with any type of epilepsy who completed both instruments. Concurrent validity was evaluated using Spearman's correlation and reliability was measured using Cronbach's alpha. RESULTS: The first stage produced a culturally appropriate NDDI-E-Y(ID). Thirty healthy adolescents and 10 adolescents with epilepsy participated in the second stage. In the third stage, another group of 30 adolescents with epilepsy took part. We obtained I-CVI and S-CVI values averaging 1. The NDDI-E-Y(ID) showed a positive and significant correlation with CESD-R (Spearman's rho = 0.671, p < 0.001). A Cronbach's alpha of 0.928 reflected a high internal consistency. SIGNIFICANCE: Based on the results, the NDDI-E-Y(ID) was found to be a valid and reliable screening instrument for detecting depression in youth with epilepsy. PLAIN LANGUAGE SUMMARY: Depression is an under-recognized problem in youth with epilepsy. Currently available depression screening tools are in English, making it less suitable for detection purposes in Indonesia. This study developed and validated the Indonesian version of the NDDI-E-Y, a depression screening tool for youth with epilepsy.

Patient-reported outcome measures for lupus nephritis: content validity of LupusQoL and FACIT-Fatigue.

BACKGROUND: Lupus nephritis (LN), a severe organ manifestation of systemic lupus erythematosus (SLE), significantly impacts health-related quality of life (HRQoL). Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and Lupus Quality of Life (LupusQoL) have been validated to measure HRQoL in SLE, but not specifically in LN. Patient-reported symptoms of LN are not well-reported. We assessed the content validity and relevance of these measures in evaluating patients with LN and their LN-related experiences. METHODS: This qualitative, interview-based study enrolled patients with LN from three US sites from a larger, retrospective survey study. The interview comprised an open-ended concept elicitation part and a more structured cognitive part. Concept elicitation was used to identify relevant themes describing the patients' experiences. Patients were asked to describe their LN-related symptoms, the severity and impact of those symptoms and their satisfaction with treatment. A cognitive interview approach evaluated the appropriate understanding of the items, instructions, and response options and asked patients about their understanding of the FACIT-Fatigue or LupusQoL measures, their relevance to the condition, and any aspects of confusion or need for better clarity of the questionnaires. All interviews were recorded and transcribed. The concept elicitation data were coded, while the cognitive interview data were tabulated to present the participants' responses next to the interview questions to support the evaluation of their understanding of the questionnaire items. RESULTS: Overall, 10 patients participated in FACIT-Fatigue and another 10 in LupusQoL interviews; 18 patients were female, 10 were Black (self-reported) and 17 were receiving maintenance treatment for LN with stable disease activity. When patients recalled their symptoms, 670 expressions of varying symptoms were reported. All patients described pain, discomfort, and energy-related symptoms. Urinary frequency and non-joint swelling were most frequently attributed to LN rather than SLE. Patients felt the questions asked in the FACIT-Fatigue and LupusQoL surveys were relevant to their LN experience. CONCLUSIONS: The symptoms reported by patients with LN were consistent with symptoms reported by the overall SLE population. However, patients indicated that some symptoms of LN were more profound than symptoms of SLE alone, affecting a broad range of areas of daily life activity and resulting in a higher burden on their HRQoL. FACIT-Fatigue and LupusQoL demonstrated content relevance as meaningful tools for patients with LN. However, further quantitative data collection is needed to ensure that these patient-reported outcome tools demonstrate good measurement properties in an LN population.

Living with Pompe disease: results from a qualitative interview study with children and adolescents and their caregivers.

BACKGROUND: Children and adolescents with Pompe disease (PD) face chronic and progressive myopathy requiring time-intensive enzyme replacement therapy (ERT). Little is known about their perspectives on the disease and its treatment. This study explored their perceptions of disease symptoms and functioning status, and more subjective feelings about the impacts on their lives as part of developing a disease-specific questionnaire. METHODS: Eleven pediatric patients aged 8-18 years and 26 caregivers from six children's hospitals in Germany, Austria, and Switzerland underwent semi-structured interviews. Data were recorded, transcribed using MAXQDA software, and analyzed using qualitative content analysis. A system of meaningful categories was developed. RESULTS: Sixteen main categories were derived across four major thematic areas: perceptions of symptoms and limitations, experiences to do with the biopsychosocial impact of PD, treatment experiences, and general emotional well-being/burden. Participants demonstrated broad heterogeneity in symptom perceptions such as muscle weakness, breathing difficulties, pain, and fatigue. Emotional appraisals of limitations were not directly proportional to their severity, and even comparatively minor impairments were often experienced as highly frustrating, particularly for social reasons. The main psychosocial topics were social exclusion vs. inclusion and experiences to do with having a disease. The main finding regarding treatment was that switching ERT from hospital to home was widely viewed as a huge relief, reducing the impact on daily life and the burden of infusions. Emotional well-being ranged from not burdened to very happy in most children and adolescents, including the most severely affected. CONCLUSION: This study provided qualitative insights into the perceptions and experiences of pediatric PD patients. Interestingly, biopsychosocial burden was not directly related to disease severity, and tailored psychosocial support could improve health-related quality of life. The present findings ensure the content validity of a novel questionnaire to be tested as a screening tool to identify patients in need of such support.

Cross-cultural adaptation and content validation of the Singapore English version of EQ-5D-Y: a qualitative study.

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.

The Autism Program Environment Rating Scale in Swedish Primary School: Cultural Adaptation and Content Validation.

There is a recognized need to improve inclusive learning environments for autistic children in primary school settings in Sweden. This study aimed to translate, cross-culturally adapt, and assess the content validity of the Swedish primary school version of the Autism Program Environment Scale (APERS), originally developed to evaluate autism program quality in educational settings in the United States. Following the translation into Swedish and the first cultural adaptation of the APERS, a content panel group of 14 professionals rated its content validity. Four of the content panel members also participated in individual interviews that provided a qualitative evaluation of the instrument's content validity. Finally, the authors piloted the APERS in 10 Swedish primary school classrooms to assess its feasibility. The ratings and qualitative information from the content panel members indicated a substantial need for the Swedish APERS in primary school, resulting in the culturally adapted APERS-Primary-Sweden (SE). The instrument demonstrated a high level of cross-cultural content validity for assessing the quality of the learning environment for students with autism in Swedish primary school settings. The pilot testing of the instrument resulted in further cultural adaptations. In conclusion, APERS-Primary-SE is a comprehensive scale that can be used to assess the quality of primary school learning environments for children with autism in Sweden. Further research is needed to evaluate the adapted instrument's effectiveness in improving the learning environment in Swedish primary school classrooms.

Design and validation of a simulated multitasking environment for assessing the cognitive load on the infantry squad leader.

The increasing cognitive load on infantry squad leaders is a common challenge in modern military operations. As this can increase health and safety risks, there is a need to study the factors responsible for the increase in cognitive load. Ecological situations inherently lack strong experimental controls; therefore, microworlds that simulate real tasks are the usual alternative to field studies. However, to the best of our knowledge, there are currently no microworlds that reproduce the main tasks of the squad leader during operations. This article adresses this gap by describing the design and validation of a new microworld: the Simulated Multitasking Environment for the Squad leader (SMES). Qualitative research was firstly conducted to highlight several squad leader's generic tasks (i.e., common to many situations in the field) that guided the design of the SMES. Psychometric validation of the SMES was then based on two experiments: (i) the first evaluated the microworld's psychometric qualities when tasks were performed individually; and (ii) the second explored concurrent tasks, reflecting real-world complexity. The results showed that the parameters manipulated for each task were relevant for inducing cognitive load, measured using a secondary detection response task and the NASA-TLX questionnaire. The SMES demonstrated satisfactory convergent and content validity in multitasking but not in single-task conditions. Performance in multitasking situations therefore does not seem to depend on task-specific skills, suggesting the existence of an independent factor-multitasking ability. Theoretical and practical implications of the SMES validation are discussed.

Psychometric properties of instruments for measuring abuse of older people in community and institutional settings: A systematic review.

Background: The examination of psychometric properties in instruments measuring abuse of older people (AOP) is a crucial area of study that has, unfortunately, received relatively little attention. Poor psychometric properties in AOP measurement instruments can significantly contribute to inconsistencies in prevalence estimates, casting a shadow of uncertainty over the magnitude of the problem at national, regional, and global levels. Objectives: This review rigorously employed the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guideline on the quality of outcome measures. It was designed to identify and review the instruments used to measure AOP, assess the instruments' measurement properties, and identify the definitions of AOP and abuse subtypes measured by these instruments, ensuring the reliability and validity of the findings. Search Methods: A comprehensive search was conducted up to May 2023 across various online databases, including AgeLine via EBSCOhost, ASSIA via ProQuest, CINAHL via EBSCOhost, EMBASE, LILACS, ProQuest Dissertation & Theses Global, PsycINFO via EBSCOhost, PubMed, SciELO, Scopus, Sociological Abstract via ProQuest, Chinese National Knowledge Infrastructure (CNKI), Google Scholar and WHO Global Index Medicus. Additionally, relevant studies were identified by thoroughly searching the grey literature from resources such as Campbell Collaboration, OpenAIRE, and GRAFT. Selection Criteria: All quantitative, qualitative (addressing face and content validity), and mixed-method empirical studies published in peer-reviewed journals or grey literature were included in this review. The included studies were primary studies that (1) evaluated one or more psychometric properties, (2) contained information on instrument development, or (3) examined the content validity of the instruments designed to measure AOP in community or institutional settings. The selected studies describe at least one psychometric property: reliability, validity, and responsiveness. Study participants represent the population of interest, including males and females aged 60 or older in community or institutional settings. Data Collection and Analysis: Two reviewers evaluated the screening of the selected studies' titles, abstracts, and full texts based on the preset selection criteria. Two reviewers assessed the quality of each study using the COSMIN Risk of Bias checklist and the overall quality of evidence for each psychometric property of the instrument against the updated COSMIN criteria of good measurement properties. Disagreements were resolved through consensus discussion or with assistance from a third reviewer. The overall quality of the measurement instrument was graded using a modified GRADE approach. Data extraction was performed using data extraction forms adapted from the COSMIN Guideline for Systematic Reviews of Outcome Measurement Instruments. The extracted data included information on the characteristics of included instruments (name, adaptation, language used, translation and country of origin), characteristics of the tested population, instrument development, psychometric properties listed in the COSMIN criteria, including details on content validity, structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, responsiveness, and interoperability. All data were synthesised and summarised qualitatively, and no meta-analysis was performed. Main Results: We found 15,200 potentially relevant records, of which 382 were screened in full text. A total of 114 studies that met the inclusion criteria were included. Four studies reported on more than one instrument. The primary reasons for excluding studies were their focus on instruments used solely for screening and diagnostic purposes, those conducted in hospital settings, or those without evaluating psychometric properties. Eighty-seven studies reported on 46 original instruments and 29 studies on 22 modified versions of an original instrument. The majority of the studies were conducted in community settings (97 studies) from the perspective of older adults (90 studies) and were conducted in high-income countries (69 studies). Ninety-five studies assessed multiple forms of abuse, ranging from 2 to 13 different subscales; four studies measured overall abuse and neglect among older adults, and 14 studies measured one specific type of abuse. Approximately one-quarter of the included studies reported on the psychometric properties of the most frequently used measurement instruments: HS-EAST (assessed in 11 studies), VASS-12 items (in 9 studies), and CASE (in 9 studies). The instruments with the most evidence available in studies reporting on instrument development and content validity in all domains (relevance, comprehensiveness and comprehensibility) were the DEAQ, OAPAM, *RAAL-31 items, *ICNH (Norwegian) and OAFEM. For other psychometric properties, instruments with the most evidence available in terms of the number of studies were the HS-EAST (11 studies across 5 of 9 psychometric properties), CASE (9 studies across 6 of 9 psychometric properties), VASS-12 items (9 studies across 5 of 9 psychometric properties) and GMS (5 studies across 4 of 9 psychometric properties). Based on the overall rating and quality of evidence, the psychometric properties of the AOP measurement instruments used for prevalence measurement in community and institutional settings were insufficient and of low quality. Authors' Conclusions: This review aimed to assess the overall rating and quality of evidence for instruments measuring AOP in the community and institutional settings. Our findings revealed various measurement instruments, with ratings and evidence quality predominantly indicating insufficiency and low quality. In summary, the psychometric properties of AOP measurement instruments have not been comprehensively investigated, and existing instruments lack sufficient evidence to support their validity and reliability.

Validation of a Questionnaire to Assess Patient Satisfaction with an Automated Drug Dispensing System.

BACKGROUND AND OBJECTIVES: Automated drug dispensing systems (ADDs) have been introduced to improve the efficiency of dispensing and patient safety. The available questionnaires measure patient satisfaction with particular aspects of ADDs. Also, the level of patient satisfaction with ADDs is not widely established. This study aimed to develop and validate a novel questionnaire to assess patient satisfaction with ADDs. METHODS: Content and construct validity procedures were used to validate the 20-item questionnaire with four domains, including pharmacy administration, dispensing practice, patient education, and the dispensing system. Two hundred consenting participants took part in this study, from those who visited the outpatient pharmacy in a government hospital. RESULTS: The internal consistency of all four scale items shows acceptable reliability (>0.7). In the exploratory factor analysis, three items were removed due to poor factor loading and cross-loading. In the confirmatory factor analysis, the model has acceptable fit indices, including the comparative fit index (0.937), Tucker-Lewis's index (0.924), standardized root mean square residual (0.051), root mean square error of approximation (0.057), and χ2/df (1.67). The convergent and discriminant validity were established, since the average variance extracted (AVE) was ≥0.5 and the squared correlation (SC) values of one construct with other constructs were less than the AVE of the specific construct. CONCLUSION: This study offered a reliable and valid 17-item questionnaire incorporating a multi-dimensional four-factor model to evaluate patient satisfaction with ADDs. The validated questionnaire can be utilized to explore patients' perspectives on ADDs.