Patient Related Outcome Measures最新文献

{"title":"Assessment of the psychometrics properties of the Senegalese kidney disease quality of life - 36 (KDQOL-36) in patients with chronic kidney disease.","authors":"Moustapha Faye, Abdou Omorou, Luc Frimat, Jonathan Epstein, Adama Sow, Ramatoulaye Abdoulahi Niang, Abdou Niang, Elhadji Fary Ka, Adama Faye, Francis Guillemin","doi":"10.1080/1179271X.2026.2688843","DOIUrl":"10.1080/1179271X.2026.2688843","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to assess the validity, reliability and responsiveness of the Senegalese kidney disease quality of life (KDQOL-36).</p><p><strong>Methods: </strong>This cross-sectional and multicenter psychometric evaluation was conducted between June and November 2024. The Wolof version of the KDQOL-36 scores was assessed in 575 Senegalese patients aged 18 years or older with stage 3-4 CKD or on dialysis, who had been followed for at least three months and not hospitalized during the previous three months. The factor structure was evaluated using confirmatory factor analysis. We assessed internal consistency and test-retest reliability using α and ω coefficients, the intraclass correlation coefficient (ICC) and Bland-Altman analysis. Construct validity was examined using \"known group analyses\", and responsiveness was evaluated using the paired Wilcoxon test, standardized response means and effect size.</p><p><strong>Results: </strong>A bifactor structure was retained for the generic module, comprising overall, physical and mental health. A three-factor structure was confirmed for the kidney disease targeted scale, including the burden, symptoms/problems and effects. The scale and subscales showed sufficient internal consistency. Test-retest reliability was moderate to good. Known group analyses revealed significant differences in the scale scores between patients who received dialysis and who did not receive dialysis, and between men and women. Overall health, physical health, symptoms/problems and effects demonstrated moderate to high sensitivity to change.</p><p><strong>Conclusions: </strong>This study provides evidence supporting the structural validity, construct validity, reliability, and responsiveness of the Senegalese Wolof version of the KDQOL-36 for assessing health-related quality of life.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"17 1","pages":"49-61"},"PeriodicalIF":2.4,"publicationDate":"2026-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13536964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148888140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinician and Researcher Experiences with Goal Attainment Scaling: A Qualitative Study on Opportunities and Challenges for Personalized Outcome Assessments.","authors":"Gunes Sevinc, Andrea Escoto-Rivera, Katie Crespo, Sue Nesto, Chere A T Chapman, Kenneth Rockwood","doi":"10.2147/PROM.S569608","DOIUrl":"10.2147/PROM.S569608","url":null,"abstract":"<p><strong>Purpose: </strong>Goal Attainment Scaling (GAS) is a personalized outcome measure that evaluates treatment response based on patient- and caregiver-prioritized goals, offering a structured yet flexible framework for assessing meaningful change. Although GAS is increasingly applied in clinical trials, its implementation remains inconsistent, and the perspectives of clinicians and researchers who use it in practice remain poorly understood. This study explored the experiences of clinicians and researchers with GAS to better understand how it is operationalized, the challenges encountered, and opportunities to improve its consistency and utility in patient-centered care and research.</p><p><strong>Participants and methods: </strong>Semi-structured interviews were conducted with 11 clinicians and academics from Canada, the United States, the United Kingdom, and Australia who had experience using GAS in clinical or research settings. Data were analyzed thematically using the Framework Method, with coding conducted inductively and supported by NVivo 12.</p><p><strong>Results: </strong>Participants valued GAS for capturing outcomes most meaningful to patients and demonstrating treatment responsiveness in heterogeneous conditions. However, clinician resistance, time demands, limited familiarity, and variability in implementation across settings were identified as key challenges. Education, peer advocacy, and digital tools were suggested as strategies to improve feasibility and consistency.</p><p><strong>Conclusion: </strong>Clinicians and researchers view GAS as a valuable patient-centered outcome measure but highlight variability in implementation as a barrier to broader adoption. Guidelines for GAS implementation, training, and supportive tools may strengthen the use of GAS in both clinical practice and research, ultimately improving the measurement of outcomes that matter most to patients.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"355-366"},"PeriodicalIF":2.4,"publicationDate":"2026-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13240604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Guide to Understanding and Analysing PROMs Scores in Wales.","authors":"Michal Pruski, Robert I Palmer, Tim Pickles, Kathleen L Withers","doi":"10.2147/PROM.S572978","DOIUrl":"10.2147/PROM.S572978","url":null,"abstract":"<p><p>This perspective article outlines the recommendations for the analysis and presentation of data collected via patient-reported outcome measures (PROMs), to promote good practice across Wales. We do not present detailed instructions or repeat what can be easily found in statistics texts, but rather focus on the overall approach that should be adopted when dealing with such data. Throughout the article, we introduce the importance of patient-reported outcome data within the National Health Service (NHS) Wales. We then briefly describe how PROM questionnaires are validated. We then introduce the different data types and describe how PROM questionnaires are structured. Following this, we highlight how the way that patient-reported outcome data is collected can affect appropriate analysis and what should be kept in mind when comparing different items within a questionnaire. We then provide some recommendations as to how to present such data and how to go about choosing appropriate inferential statistics tests for further analysis. Finally, we go over some of the potential consequences of not analysing the data appropriately. Additionally, we also include a simplified version of these recommendations that can be shared with a wider audience.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"343-353"},"PeriodicalIF":2.4,"publicationDate":"2026-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13240605/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Content validity of the Familial Chylomicronemia Syndrome Symptoms and Impacts Scale (FCS-SIS) for severe hypertriglyceridemia (sHTG).","authors":"Asia Sikora Kessler, Tammy Michelle Brown, Bonita Basnyat, Aaron Yarlas, Jennifer Dine","doi":"10.1080/1179271X.2026.2672471","DOIUrl":"10.1080/1179271X.2026.2672471","url":null,"abstract":"<p><strong>Objective: </strong>Severe hypertriglyceridemia (sHTG) and familial chylomicronemia syndrome (FCS) are metabolic conditions associated with an increased risk of adverse health outcomes. The FCS Symptoms and Impacts Scale (FCS-SIS) was developed to assess the symptoms and impacts of FCS. This study assessed the content validity of the 4 FCS-SIS symptom items in adults with sHTG.</p><p><strong>Methods: </strong>Two iterative rounds of qualitative interviews were conducted with adults (aged ≥ 18 years) who had clinician-confirmed sHTG (triglycerides ≥ 500 mg/dL) and recently experienced ≥ 2 symptoms of sHTG. Participants described their initial experiences and symptoms of sHTG during concept elicitation. Cognitive debriefing of the 4 FCS-SIS symptom items assessed relevance, interpretability, answerability, and meaningful change.</p><p><strong>Results: </strong>Among 20 participants, the most frequently reported, most bothersome, and most important-to-treat sHTG symptoms were difficulty thinking (n = 20), physical fatigue (n = 20), diarrhea (n = 19), and abdominal pain (n = 18), which the 4 FCS-SIS symptom items assess. Participants reported these items to be easy to understand (n = 20) and, for most items, reported that a 1- to 2-point improvement would be meaningful.</p><p><strong>Conclusion: </strong>FCS-SIS symptom items are content-valid items for the assessment of sHTG symptoms in adults with sHTG.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"17 1","pages":"35-48"},"PeriodicalIF":2.4,"publicationDate":"2026-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13536960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148888106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-reported outcome measures (PROMs) capturing therapy adherence of cancer patients: an umbrella review.","authors":"Luise Richter, Sophie Pauge, Wolfgang Greiner","doi":"10.1080/1179271X.2026.2669130","DOIUrl":"10.1080/1179271X.2026.2669130","url":null,"abstract":"<p><strong>Background: </strong>Adherence is a key determinant of treatment success in oncology and, according to the World Health Organization (WHO), describes how closely patients follow the recommendations agreed upon with their healthcare provider, including taking medications, adhering to dietary plans, or making lifestyle changes. Patient-reported outcome measures (PROMs) provide insights into patients' perceptions, barriers, and beliefs. However, a comprehensive overview of adherence-related PROMs in oncology is lacking.</p><p><strong>Methods: </strong>We conducted a systematic umbrella review in PubMed and Embase up to October 2024 in adult cancer patients. A qualitative synthesis was performed to classify adherence dimensions according to the WHO framework and to evaluate the validation status.</p><p><strong>Results: </strong>Of 6,073 records screened, 89 systematic literature reviews (SLR) were included, encompassing 599 PROM applications. Most PROMs assessed medication adherence (41.1%). 4.8% of PROMs measured multiple adherence dimensions. 49.7% of PROMs were validated, while for 39.7% of PROMs validation status was not reported.</p><p><strong>Conclusion: </strong>Adherence-related PROMs in oncology predominantly focus on medication, while lifestyle and multidimensional aspects remain underrepresented. Validation status is frequently unclear. Standardized and validated modular PROMs are needed to inform the choice of PROMs for monitoring patient adherence in clinical practice and to enhance health outcomes.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"17 1","pages":"25-34"},"PeriodicalIF":2.4,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13536962/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148888260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Translation and Cross-Cultural Adaptation into French of the Birth Satisfaction Scale - Revised (BSS-R).","authors":"Anthony Pernoud, Nicole Jastrow, Caroline J Hollins Martin, Colin R Martin, Hugo Bothorel","doi":"10.2147/PROM.S555834","DOIUrl":"10.2147/PROM.S555834","url":null,"abstract":"<p><strong>Purpose: </strong>The Birth Satisfaction Scale - Revised (BSS-R) is a widely used patient-reported outcome measure (PROM) for assessing childbirth experience. However, no French translation and adaption currently exists, limiting its use in French-speaking populations. The objective of this study was to translate and adapt the BSS-R into French (Fr-BSS-R).</p><p><strong>Patients and methods: </strong>The questionnaire was translated and culturally adapted using a structured 10-step procedure in line with the guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). During the cognitive debriefing stage, 15 mothers evaluated each item, scoring their level of comprehension on a scale from 1 to 10.</p><p><strong>Results: </strong>The French version was very well understood by the 15 mothers, with a mean comprehension score of 9.5 ± 1.1 out of 10. Both forward and backward translations were very consistent and considered accurate by the original developer. Five ratings out of 150 (3%) were < 7 and concerned items 1, 3, 8 and 9. Comments prompted the authors to slightly modify the French translation produced to improve semantic equivalence.</p><p><strong>Conclusion: </strong>This work presents the creation of a French adaptation of the BSS-R (Fr-BSS-R), developed in accordance with ISPOR guidelines for translation and cross-cultural adaptation, thereby enabling its application in French-speaking populations. Future research should investigate the psychometric properties of the Fr-BSS-R to support its broader use in French-speaking populations.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"555834"},"PeriodicalIF":2.4,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13179515/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147964364","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality of life, depression and sexual function in men living with HIV under effective antiretroviral therapy compared with healthy controls.","authors":"Özlem Güler, Demir Akhan, Gamze Kara Sözen, Sıla Akhan","doi":"10.1080/1179271X.2026.2664443","DOIUrl":"10.1080/1179271X.2026.2664443","url":null,"abstract":"<p><strong>Purpose: </strong>Combination antiretroviral therapy (cART) has improved outcomes in individuals living with HIV. This study investigated quality of life, mental health, and sexual function in virologically suppressed men.</p><p><strong>Patients and methods: </strong>This case-control study compared quality of life, depression, and sexual function of 39 heterosexual men on cART with viral suppression and 60 healthy male controls. Participants completed the EUROHIS-QOL 8, Beck Depression Inventory (BDI), and Arizona Sexual Experience Scale (ASEX) questionnaires.</p><p><strong>Results: </strong>HIV group's mean age was 39 years, controls 41.5 years, with similar demographics. Median EUROHIS-QOL8 and BDI scores were similar between groups. While ASEX scores were higher in HIV patients (<i>p</i> = .032), this difference did not result in a higher prevalence of sexual dysfunction based on established ASEX criteria. BDI scores strongly negatively correlated with EUROHIS-QOL8 in the HIV group (<i>r</i> = -.731, <i>p</i> < .001) and moderately in controls (<i>r</i> = -.475, <i>p</i> < .001). Quality of life decreased with depressive symptoms in both groups.</p><p><strong>Conclusion: </strong>Among men with HIV who achieved viral suppression, no significant differences were found versus healthy controls in quality of life, depression, or sexual dysfunction. These findings support individual evaluation rather than HIV status-based assumptions.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"17 1","pages":"16-24"},"PeriodicalIF":2.4,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13536959/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148888280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of a respiratory symptom score from the Quality of Life-Bronchiectasis Questionnaire in adults with <i>Mycobacterium avium</i> complex lung disease.","authors":"Daniel Serrano, Mariam Hassan, Marie-Laure Nevoret, Dayton W Yuen, Shauna McManus, Lauren Podger, Sam Parsons, Bryant Barnes, Charles L Daley, Kevin C Mange","doi":"10.1080/1179271X.2026.2655469","DOIUrl":"10.1080/1179271X.2026.2655469","url":null,"abstract":"<p><strong>Objective: </strong>To assess the psychometric properties of a respiratory symptom score from the Quality of Life-Bronchiectasis Questionnaire in adults with <i>Mycobacterium avium</i> complex (MAC) lung disease.</p><p><strong>Methods: </strong>Structural validity, internal consistency, test-retest reliability, and known-groups validity were assessed using data from the ARISE (NCT04677543) and ENCORE (NCT04677569) phase 3 trials. Convergent validity was assessed using Exacerbations of Chronic Pulmonary Disease Tool (EXACT), EXACT Respiratory Symptoms (E-RS), St. George Respiratory Questionnaire (SGRQ), and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. Anchor-based meaningful within-patient change (MWPC) thresholds were estimated using the Patient Global Impression of Severity Respiratory scale.</p><p><strong>Results: </strong>In total, 362 patients were included for cross-sectional (ARISE: 97, ENCORE: 265) and longitudinal (ARISE: 99) validation analyses. Modern psychometric methods supported item relevance and an essentially unidimensional mean score. The respiratory symptom score demonstrated adequate internal consistency (McDonald's omega: 0.86, Cronbach's alpha: 0.81), test-retest reliability (intraclass correlation coefficient: 0.73), convergent validity (EXACT: -0.72, E-RS: -0.72, SGRQ: -0.77, FACIT-Fatigue: 0.51), and known-groups validity. The estimated MWPC threshold was a 16.67-point median change from baseline (95% CI: 8.33-16.83 points).</p><p><strong>Conclusions: </strong>The respiratory symptom score is a robust, sensitive, and responsive measure of respiratory symptoms in adults with a new or recurrent MAC lung disease diagnosis.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"17 1","pages":"4-15"},"PeriodicalIF":2.4,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13536775/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148888222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deriving Health Utilities from the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF) Using Mapping and Discrete Choice Experiments.","authors":"Adam B Smith, Tom Bromilow, Stuart Mealing, Charlotte Graham, Damian Lewis, Frederic Girard, Audrey DunnGalvin","doi":"10.2147/PROM.S571549","DOIUrl":"10.2147/PROM.S571549","url":null,"abstract":"<p><strong>Purpose: </strong>Health-related quality of life (HRQoL) measures in the form of health utilities are valuable for economic evaluations of the effectiveness of food allergy interventions. However, traditional HRQoL instruments lack the sensitivity to generate health utilities that capture the impact that food allergies, such as peanut allergies, may have on children's mental health and daily activities. This study used mapping and discrete choice experiment (DCE) methods to generate health utilities from the Food Allergy Quality of life Questionnaire-Parent Form (FAQLQ-PF), which were then applied to clinical trial data.</p><p><strong>Patients and methods: </strong>Health utilities (HU) were generated using two methods: mapping and DCE. Parents of children with peanut allergies (N=159) completed the FAQLQ-PF and EQ-5D-Y-Proxy-1 questionnaires. Mapping algorithms were developed once the FAQLQ-PF responses were mapped onto the EQ-5D-3L utilities. A composite DCE with time trade-off and a vignette was conducted among parents without peanut allergic children (N=767). The utilities derived from the mapping and DCE methods were applied to clinical trial data (PEPITES and PEOPLE) for an epicutaneous peanut patch (DBV712).</p><p><strong>Results: </strong>The mapping algorithm showed an association of 0.199 between FAQLQ-PF and EQ-5D-3L utilities. The DCE disutilities were highest for severe food-related anxiety, emotional distress, and social limitations. Once applied to the clinical trial data, the HU derived from the mapping algorithm demonstrated statistically significant HRQoL improvements for the intervention group at 36 months. Using the DCE-derived utilities, statistically significant HRQoL improvements for the intervention group were demonstrated at both 24- and 36-months. The effect size analysis demonstrated that the DCE-derived utilities were more responsive than mapped utilities.</p><p><strong>Conclusion: </strong>DCE-derived utilities demonstrated greater responsiveness to changes in HRQoL compared with mapped utilities, suggesting their potential use in economic evaluations and HTA submissions for peanut allergy interventions. The DCE-derived health utilities showed greater sensitivity to changes in HRQoL. These utilities can be used in health technology assessments to better capture the impact of peanut allergy treatments on children's quality of life.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"571549"},"PeriodicalIF":2.4,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13118655/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Psychometric Validation of the Speed of Change in Feeling of Health (SCFH) Questionnaire: Findings from the NEWTON Sub-Study in Italian Asthma Patients.","authors":"Ilaria Baiardini, Cristiano Caruso, Walter Castellani, Alberto Ricci, Lucio Michieletto, Cecilia Calabrese, Eleonora Ingrassia, Alessio Piraino, Lucia Simoni, Alessandra Ori, Fulvio Braido","doi":"10.2147/PROM.S543501","DOIUrl":"10.2147/PROM.S543501","url":null,"abstract":"<p><strong>Purpose: </strong>Speed of clinical response to a new therapeutic intervention is a critical determinant of the overall treatment outcomes, but tools focused on asthma response speed are currently unavailable. This study aimed to validate the psychometric properties of a new questionnaire initially written in Italian, the Speed of Change in Feeling of Health (SCFH), in patients with asthma.</p><p><strong>Patients and methods: </strong>Two hundred and seventy subjects with not-well- or poorly controlled asthma, enrolled in the Italian sites of the NEWTON real-world study, were asked to complete the provisional version of SCFH and three validated questionnaires, the Stanford Expectation of Treatment Scale (SETS), the 5-item version of the Asthma Control Questionnaire (ACQ-5), and the Global Rating Scale (GRS). Internal consistency and validity were determined. Moreover, we assessed the minimal clinically important difference (MCID) using anchor-based method.</p><p><strong>Results: </strong>One hundred and ninety-six patients completed the questionnaire at least once at 7 (±1), 14 (±2), or 30 (±3) days after starting BDP/FF NEXThaler^® 100/6 μg treatment. We started from SCFH provisional questionnaire of 30 items, the internal consistency of which revealed a high redundancy (Cronbach's alpha of 0.98), prompting its reduction to an 8-item questionnaire (SCFH-8; Cronbach's alpha = 0.90). Known-group validity indicated significant differences in SCFH-8 scores (p = 0.0003) at 30 (±3) days after enrollment between improved and non-improved subjects, as defined by changes in ACQ-5 scores. The study confirmed the convergent validity through comparisons with the SETS and the ACQ-5 questionnaires. A clinically relevant change in feeling of health was observed in 43.3% of participants at 7 days, while the cumulative frequency of patients reporting a clinically relevant change in their feeling of health at 30 days after enrollment was 70.4%.</p><p><strong>Conclusion: </strong>The Italian version of SCFH-8 is a valid, short tool with good psychometric properties for determining the speed of change in health perception after starting treatment.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"543501"},"PeriodicalIF":2.4,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13118647/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147777962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}