Journal of Patient-Reported Outcomes最新文献

{"title":"Psychometric validation of the severity of chronic cough diary, leicester cough questionnaire, and a cough severity visual analogue scale in patients with refractory chronic cough.","authors":"Andrew Trigg, Nathan Clarke, Christoph Gerlinger, Ulrike Krahn, Adam Gater, Claudia Haberland","doi":"10.1186/s41687-025-00888-z","DOIUrl":"10.1186/s41687-025-00888-z","url":null,"abstract":"<p><strong>Background: </strong>Refractory chronic cough (RCC) is commonly reported in primary care and associated with significant morbidity. Patient-reported outcome (PRO) measures are important for evaluating the efficacy of antitussive medications for RCC in clinical trials from the patient-perspective. Psychometric properties of Severity of Chronic Cough Diary (SCCD) Cough Severity and Cough Frequency, Leicester Cough Questionnaire (LCQ) Total and Physical Domain and Cough Severity Visual Analogue Scale (VAS) scores using data from a 12-week Phase 2b trial evaluating the efficacy of eliapixant in patients with RCC (NCT04562155) are reported.</p><p><strong>Results: </strong>Quality of completion for the SCCD, LCQ and Cough Severity VAS across the study was high, no ceiling or floor effects were observed at baseline. Internal consistency for LCQ Total and Physical domain scores was also high (Cronbach's alpha = 0.939 and 0.806, respectively). SCCD Cough Frequency and Cough Severity, LCQ Total and Physical domain, and Cough Severity VAS scores demonstrated strong test-retest reliability (Intraclass correlation coefficient ≥ 0.848) among participants defined as stable between Week 3 and Week 4 according to Patient Global Impression of Severity (PGI-S) ratings and Awake Cough Count readings. Construct validity was supported by known-groups comparisons, with large differences (effect sizes 1.99-4.16) observed between groups categorized according to PGI-S ratings and objective Awake Cough Counts. Ability to detect improvement was supported by large effect sizes (≥0.8) observed for mean changes in SCCD, LCQ and Cough Severity VAS scores from baseline to Week 12 among participants classified as 'improved' according to PGI-S/PGI-C ratings and Awake Cough Counts. Triangulated thresholds (score range) for meaningful within-patient improvement based on anchor-based assessments were -0.82 for SCCD Cough Frequency (0-4), -0.69 for SCCD Cough Severity (0-4), 2.36 for the LCQ Total (3-21), 0.77 for the LCQ Physical (1-7) and -17.73 for the Cough Severity VAS (0-100) scores.</p><p><strong>Conclusion: </strong>Findings support the reliability, validity and responsiveness of the newly developed SCCD Cough Frequency and Severity items as fit-for-purpose PRO measures of cough frequency or severity for use in drug development programs within RCC. The LCQ Total, LCQ Physical Domain and Cough Severity VAS also exhibit acceptable measurement properties for use in this population.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"65"},"PeriodicalIF":2.4,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12158865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267455","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":"Participation and quality of life of Nepalese children with visual impairment in comparison with normally sighted peers: a cross sectional comparative study.","authors":"Srijana Adhikari, Ellen Bernadette Maria Elsman, Ruth Marie Antoinette van Nispen, Fleur Van Rens, Manish Poudel, Gerardus Hermanus Maria Bartholomeus van Rens","doi":"10.1186/s41687-025-00893-2","DOIUrl":"10.1186/s41687-025-00893-2","url":null,"abstract":"<p><strong>Background: </strong>Poor vision compromises quality of life and participation in different daily life activities of children such as, sports, leisure time, interactive play and social interaction. The purpose of this cross - sectional study is to investigate participation and quality of life of children with visual impairment (VI) and blindness compared with normally sighted peers.</p><p><strong>Methodology: </strong>Children aged 7-17 years with blindness (n = 100), moderate to severe VI (n = 100) and normal sight (n = 100) completed Nepalese versions of the Participation and activity inventory children and youth (PAI-CY 7-12 and 13-17), L. V. Prasad functional vision questionnaires (LVP-FVQ II) and Pediatric Eye Questionnaires (PedEyeQ 5-11 and 12-17). The measurement properties of PAI -CY was studied. All (sub) scores were compared between three groups. Associations between the severity of VI and outcomes were assessed with age and sex adjusted linear regression analyses.</p><p><strong>Results: </strong>Children with blindness scored worse than children with VI, who scored worse than normally sighted children on the PAI-CY 7-12, the physical functioning subscale of the PAI-CY 13-17 and the LVP-FVQ II(p = < 0.001).However, for the psychosocial functioning subscale of PAI-CY 13-17, children with blindness scored better than children with VI(p = < 0.01). On the PedEyeQ, young children (5-11) with blindness on all subscales, and older children (12-17 years) with blindness on the functional vision subscale scored worse than children with VI(p = < 0.01).Regression models showed that both moderate/severe VI and blindness were significantly associated with worse PAI-CY, LVP-FVQ II, PedEyeQ 5-11 and PedEyeQ 12-17 functional vision subscale scores(p = < 0.01).</p><p><strong>Conclusion: </strong>Younger children with blindness showed worse participation and quality of life compared to children with VI, whereas results for older children showed a mixed pattern with children with blindness showing better participation in psychosocial domain. Appropriate low vision rehabilitation interventions are needed for children with VI and blindness to increase their participation and quality of life to the level of their normally sighted peers as far as possible. Future studies could include children who do not attend school and may have worse participation and quality of life than children in our study.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"64"},"PeriodicalIF":2.4,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12141697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227014","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":"Stakeholders' perspectives on implementing and integrating patient-reported outcome measures (PROMs) in health systems - insights from Alberta, Canada.","authors":"Fatima Al Sayah, Hilary Short, Arto Ohinmaa, Stafford Dean, Brenda Hubley, Markus Lahtinen, Jeffrey A Johnson","doi":"10.1186/s41687-025-00887-0","DOIUrl":"10.1186/s41687-025-00887-0","url":null,"abstract":"<p><strong>Background: </strong>Patient-reported outcome measures (PROMs) are valuable tools for evaluating outcomes of healthcare interventions and have been increasingly used in health systems around the world. While PROMs adoption has grown globally, variations exist in their use across the health system. This stakeholder engagement and consultation activity aims to understand factors impacting PROMs adoption, implementation, and utilization, and identify strategies for enhancing utilization of PROMs data within the healthcare system in Alberta, Canada.</p><p><strong>Methodology: </strong>Key stakeholders from various roles were interviewed, including PROMs programs, health system improvement, data analytics, clinical practice, evaluation, health economics, and research, from diverse clinical areas, including cancer, primary care, epilepsy, rehabilitation, arthroplasty, cardiovascular surgery, and rheumatology. Interviews were recorded, transcribed and analyzed using thematic analysis. Results were synthesized using the Consolidated Framework for Implementation Research (CFIR) and Diffusion of Innovation Framework (DOI).</p><p><strong>Results: </strong>A total of 25 interviews, lasting between 45 and 60 minutes, were completed. Factors impacting the adoption, implementation and utilization of PROMs within the Alberta healthcare system included: (1) Intervention characteristics: shared understanding of PROMs, challenges in capturing relevant patient outcomes, standardization and integration of PROMs, modalities of data collection, making PROMs actionable at the patient-clinician level, and interpreting PROMs data; (2) Inner setting: Cultural shift towards patient-centered care, change management and clinician mindset, organizational commitment and support, integration into broader measurement frameworks, access to PROMs data, potential for replication and adaptation, and importance of incentives and requirements; (3) Outer setting: Resource constraints, policy and systemic challenges, focus on value-based care, and responsible use of PROMs data; (4) Characteristics of individuals: Expertise and understanding of PROMs, and stakeholder engagement and education; and (5) Process: Balancing bottom-up and top-down approaches, workflow integration, patient engagement, and continuous evaluation and quality improvement.</p><p><strong>Conclusions: </strong>The study highlights factors influencing PROMs adoption in Alberta, including the need for a unified understanding, workflow integration, and electronic data use. Key strategies involve fostering patient-centered care, ensuring organizational support, addressing resource and policy issues, and providing targeted education. Engaging early adopters and offering incentives can improve PROMs integration and patient outcomes.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"63"},"PeriodicalIF":2.4,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12141181/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227015","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":"Cross-cultural adaptation, validity, and reliability of the Danish version of the neurophysiology of pain questionnaire.","authors":"Nikolaj Agger, Thor Andre Brøndberg Stæhr, Michael Skovdal Rathleff, Lene Baad-Hansen, Shellie Boudreau, David Høyrup Christiansen","doi":"10.1186/s41687-025-00899-w","DOIUrl":"10.1186/s41687-025-00899-w","url":null,"abstract":"<p><strong>Background: </strong>Despite advances in medicine and technology, pain remains a significant global burden. Improving pain education for undergraduate healthcare students is considered an important step toward enhancing pain management. The Neurophysiology of Pain Questionnaire (NPQ) is commonly used to assess pain knowledge in healthcare students, but its validity and reliability in this population remain uncertain. This study aimed to translate and cross-culturally adapt the NPQ for Danish-speaking healthcare students and evaluate its measurement properties in Danish physiotherapy, medicine, and odontology students.</p><p><strong>Methods: </strong>The study was conducted in two phases: (1) translation and cross-cultural adaptation of the NPQ following international guidelines, and (2) a cross-sectional study to evaluate its validity and reliability in a sample of 224 Danish undergraduate healthcare students. Structural validity was assessed using exploratory factor analysis. Internal consistency was evaluated using Cronbach's alpha, while test-retest reliability was determined using the intraclass correlation coefficient (ICC). Measurement error was analyzed using the standard error of measurement (SEM) and minimal detectable change (MDC).</p><p><strong>Results: </strong>Factor analysis revealed 11 factors, each with eigenvalues below 1, suggesting poor structural validity. Factor loadings were below the recommended threshold of 0.50, indicating weak item clustering. Internal consistency was low (Cronbach's alpha = 0.37, 95% CI: 0.27 to 0.47), and test-retest reliability was poor (ICC = 0.39, 95% CI: 0.03 to 0.66). Measurement error analysis showed an SEM of 1.94 (95% CI: 1.54 to 2.63) and an MDC of 5.38 (95% CI: 4.27 to 7.28). No floor or ceiling effects were observed.</p><p><strong>Conclusions: </strong>The Danish version of the NPQ demonstrated poor structural validity, internal consistency, and reliability in undergraduate healthcare students. These findings raise concerns about its suitability for assessing pain neurophysiology knowledge in this population. Alternative tools or modifications to the NPQ may be necessary to improve its measurement properties.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"62"},"PeriodicalIF":2.4,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12137856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144217152","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":"Person-centred ostomy care: a qualitative study of patients' experiences with routine use of a clinical feedback system during consultations : Word count.","authors":"Lill Anette Juvik, John Roger Andersen, Kirsten Lerum Indrebø, Anne Marie Sandvoll","doi":"10.1186/s41687-025-00900-6","DOIUrl":"10.1186/s41687-025-00900-6","url":null,"abstract":"<p><strong>Background: </strong>Adapting to life with an ostomy can be challenging due to significant bodily changes. To better meet patients' needs and support their adjustment, a clinical feedback system (CFS) with patient-reported outcomes was developed for routine outpatient follow-up consultations with stoma care nurses (SCNs) in specialist health care services. While results from its use prior to consultations are promising, little is known about patients' perceptions of CFS use in consultations with SCNs. Thus, we aimed to explore how patients experience the routine use of the CFS during follow-up consultations in ostomy care.</p><p><strong>Methods: </strong>An inductive qualitative design was employed, involving semi-structured individual interviews with 27 patients using the CFS as part of routine care. Data were analysed using reflexive thematic analysis.</p><p><strong>Results: </strong>The overarching theme, \"A flexible, engaged, person-centred follow-up,\" was developed, along with four themes: (1) Explicit and implicit use of information in consultations, (2) A springboard for deeper dialogue on sensitive issues, (3) Reassurance that changes in health status will be captured and adequately assessed, and (4) Utility depends on continuity of use. There were variations in how patients experienced their responses being utilised by the SCNs during consultations. Responses were referenced implicitly and explicitly, with a preference for direct communication. Patients found personal value in using the CFS, as it facilitated communication, particularly on sensitive topics. SCNs' use of the CFS and expertise provided a sense of reassurance when health status was assessed. Regular use of the CFS and a clear understanding of its purpose enhanced its utility and enabled patients to take a more active role in their treatment.</p><p><strong>Conclusion: </strong>The use of the CFS in ostomy care appears promising. It can improve SCNs' ability to tailor care to patients' needs. However, the tool should be applied consistently to realise its full potential in clinical practice.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"61"},"PeriodicalIF":2.4,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12126391/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144192364","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 properties of the EQ-5D-5L in diabetes mellitus patients in Spain.","authors":"Amaia Bilbao-González, Marta González-Sáenz de Tejada, Montse Ferrer, Yolanda Ramallo-Fariña, Miguel Paja-Fano, Carlos García-Forero, Daniela Mestre, Iñigo Gorostiza-Hormaetxe","doi":"10.1186/s41687-025-00874-5","DOIUrl":"10.1186/s41687-025-00874-5","url":null,"abstract":"<p><strong>Background: </strong>The EQ-5D-5L five-dimensional instrument, is one of the most widely used generic preference-based questionnaires to measure health-related quality of life and to estimate utility indices for use in economic evaluation. This study aimed to assess the psychometric properties of the Spanish EQ-5D-5L questionnaire in patients with Diabetes Mellitus (DM) assessing reliability, validity, and item-level properties such as item functioning.</p><p><strong>Methodology: </strong>We included 133 patients with DM who completed the EQ-5D-5L, the Audit on Diabetes-Dependent Quality of Life (ADDQoL), the Hospital Anxiety and Depression Scale (HADS), one question about general health and sociodemographic, and clinical data. The reliability was assessed by Cronbach's alpha, and the item functioning by the item response theory (IRT). Convergent validity was tested using the Spearman correlation coefficient between EQ-5D-5L, ADDQoL, HADS and the general health question. We examined known-groups validity by comparing the EQ-5D-5L scores between subgroups defined by age, gender, BMI, regular physical activity, disease duration, glycemic control by glycosylated blood hemoglobin (HbA1c) (%), type of DM, general health and anxiety and depression level using t-test, ANOVA, Wilcoxon or Kruskal-Wallis tests.</p><p><strong>Results: </strong>The reliability was supported with a Cronbach's alpha of 0.78. The IRT results supported the unidimensionality and showed adequate item functioning, except for the anxiety/depression dimension. The item with highest discriminatory power was usual activities dimension, followed by self-care and mobility dimensions. The EQ-5D-5L showed adequate convergent validity, with high correlation with the ADDQoL, HADS and general health. Older age, women, obese, no regular physical activity, ≥ 10 years of disease duration, poor glycemic control, poorer general health and higher anxiety and depression level linked with lower EQ-5D-5L scores.</p><p><strong>Conclusions: </strong>These findings support the adequate psychometric properties of the EQ-5D-5L in patients with DM, supporting its use for clinicians and researchers as an outcome measure and for use in economic evaluation studies.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"60"},"PeriodicalIF":2.4,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12122406/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175148","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":"Structural validity and test-retest reliability of the Patient Reported Inventory of Self-Management of Chronic Conditions (PRISM-CC) in a Swedish population of seventy-year-olds with long-term health conditions.","authors":"Ingrid Olsson, George Kephart, Tanya Packer, Sabine Björk, Ulf Isaksson, Yu-Ting Chen, Anna Nordström, Åsa Audulv","doi":"10.1186/s41687-025-00892-3","DOIUrl":"10.1186/s41687-025-00892-3","url":null,"abstract":"<p><strong>Background: </strong>Self-management is internationally recognized as important to maintain independence, quality of life and to minimize the risk of poor health outcomes, especially among persons with multi-morbidity. Self-management can be especially challenging for older adults, who have higher rates of multi-morbidity and experience diverse impacts of long-term health conditions on everyday life. Good measures of self-management are currently lacking. The Patient Reported Inventory of Self-Management of Chronic Conditions (PRISM-CC) is a new, generic, multidimensional measure of self-perceived ease or difficulty with self-management, that overcomes many of the limitations of existing measures.</p><p><strong>Objectives: </strong>To test the structural validity and test-retest reliability of the Swedish version of the PRISM-CC among seventy-year-olds with long-term health conditions.</p><p><strong>Methods: </strong>Translation of PRISM-CC items into Swedish followed the Patient-Reported Outcome (PRO) Consortium process. Survey data (n = 516 Swedish seventy-year-olds with ≥1 long-term health condition) was used to assess structural validity of the 36-item PRISM-CC using multidimensional item response theory (IRT) models. Test-retest reliability was assessed on a subsample of 58 individuals using intra-class correlation coefficient (ICC) and Bland-Altman Plots.</p><p><strong>Results: </strong>The Swedish PRISM-CC demonstrated good internal consistency with Cronbach's alpha >0.8 for all domains, and good fit to a graded response IRT model (RMSEA 0.034, SRMSR 0.050, CFI 0.952 and TLI 0.945). All 36 items had standardized loadings >0.7. ICC showed moderate to good test-retest reliability for all seven domains. The Bland-Altman plots showed minimal bias and good test-retest agreement for all domains.</p><p><strong>Conclusion: </strong>The Swedish PRISM-CC showed good structural validity and test-retest reliability in this sample of relatively healthy seventy-year-olds with long-term health condition(s). Further validation in a population with more severe health issues is needed.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"59"},"PeriodicalIF":2.4,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12119446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144162802","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":"Health Related Quality of Life (HRQoL) after transcatheter aortic valve implantation in aortic stenosis patients: exploring a novel threshold for clinically significant improvement after 12 months.","authors":"Marte Sævik, Marit Helen Andersen, Jan Otto Beitnes, Lars Aaberge, Per Steinar Halvorsen","doi":"10.1186/s41687-025-00894-1","DOIUrl":"10.1186/s41687-025-00894-1","url":null,"abstract":"<p><strong>Aim: </strong>The study aimed to determine the proportion of patients with significant improvements in Health-Related Quality of Life (HRQoL) 12 months after Transcatheter Aortic Valve Implantation (TAVI), using a threshold for physical function (PF) and physical role (RP) domains of the SF-36 questionnaire. Additionally, we explored shared baseline characteristics of patients reporting these improvements.</p><p><strong>Methodology: </strong>In this prospective observational study, 88 patients with symptomatic, severe aortic stenosis (AS) and preserved ejection fraction were enrolled between April 2017 and February 2020. Exclusion criteria were clinical instability, pacemaker, chronic AF, comorbidities with life expectancy < 1 year. HRQoL was evaluated before and 12 months after transfemoral TAVI using the Norwegian version 2.0 of SF-36, and presented as mean (95% confidence interval). Other outcome measures were 6-minute walking test and NYHA- classification. Independent samples t-test or Mann-Whitney U test was used for between-group comparisons as appropriate. Logistic regression or Chi2-test were used to explore associations between changes in PF and RP and clinical parameters. Statistical significance was set at p ≤ 0.05, and clinically significant changes in HRQoL were defined as increase of ≥ 15 points in the PF and RP categories.</p><p><strong>Results: </strong>Mean age of the cohort was 80 ± 6 years. 44 (50%) patients reported clinically significant improvement in PF, and 46 (52%) in the RP domain. Baseline scores were significantly lower in patients reporting clinical improvement after TAVI, with PF scores pre intervention 43.07 (37.37-48.78) vs. 65.34 (59.01-71.68), p < 0.001, and RP 36.01 (29.56-42.46) vs. 59.92 (50.91-68.92), p < 0.001. No significant associations were found between improvement in domain scores and parameters from the routine baseline examination, but having ≥ 15-point improvement correlated to baseline PF and RP scores.</p><p><strong>Conclusion: </strong>Our study highlights the importance of defining a uniform threshold for clinically significant improvement in the SF-36 HRQoL questionnaire for patients undergoing TAVI. Half of the patients reported favorable long-term outcome for PF and RP aspects of SF-36. This emphasizes the importance of HRQoL assessment in the preoperative work up for patients undergoing TAVI.</p><p><strong>Trial registration: </strong>https://www.</p><p><strong>Clinicaltrials: </strong>gov/ 05.04.2017 with ID NCT03107923.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"58"},"PeriodicalIF":2.4,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12106267/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143867","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, cross-cultural adaptation, and validation of the Norwegian version of the Keratoconus Outcomes Research Questionnaire.","authors":"Eilin Lundanes, Svein Magne Roten, Helle Kristine Falkenberg, Lena Leren, Vibeke Sundling","doi":"10.1186/s41687-025-00896-z","DOIUrl":"10.1186/s41687-025-00896-z","url":null,"abstract":"<p><strong>Purpose: </strong>To translate and adapt the Keratoconus Outcomes Research questionnaire (KORQ) to Norwegian language, culture, and environment, and to validate the translated version in a Norwegian population with keratoconus.</p><p><strong>Methods: </strong>KORQ was translated to Norwegian using a multi-step methodology. Persons with keratoconus submitted responses to KORQ-NO and NEI VFQ-25 through a digital platform, and a retest of KORQ-NO was performed over the telephone. Additional data from a clinical intervention study was included. The psychometric properties of KORQ-NO were assessed by Rasch analysis. Test-retest reliability, construct validity, and responsiveness were explored by Intraclass Correlation Coefficients, Spearman correlations and Wilcoxon Signed-rank test.</p><p><strong>Results: </strong>KORQ-NO and NEI VFQ-25 were completed by 165 participants with keratoconus. With few adjustments, the \"Activity limitations\" (AL) and \"Symptoms\" (S) subscales of KORQ-NO exhibit acceptable psychometric properties with good model fit, high internal reliability, and well-targeted items to the population. Deletion of four items (AL3, AL3b, AL12, AL15) improved dimensionality of the \"Activity limitations\" subscale. Differential item functioning was present in two items (AL4 and AL6). Participants and optometrists confirmed content validity, and KORQ-NO exhibited good test-retest reliability (AL ICC = 0.90 and S ICC = 0.81), construct validity, and responsiveness.</p><p><strong>Conclusions: </strong>Successful translation and adaptation of KORQ to Norwegian language, culture and environment was confirmed by acceptable psychometric properties, with good validity, reliability, and responsiveness. The authors support the use of KORQ-NO in research, clinical practice, and as documentation for national insurance benefit applications.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"57"},"PeriodicalIF":2.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12098238/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144120319","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 EORTC QLQ-OES18 in patients with advanced or metastatic esophageal squamous cell carcinoma.","authors":"Lauren Podger, Daniel Serrano, Liyun Li, Lin Zhan, Boxiong Tang, Gisoo Barnes","doi":"10.1186/s41687-025-00891-4","DOIUrl":"10.1186/s41687-025-00891-4","url":null,"abstract":"<p><strong>Background: </strong>The EORTC QLQ-OES18 has previously demonstrated clinical validity; however, there are limited published psychometric data for patients with advanced esophageal squamous cell carcinoma (ESCC). We evaluated the measurement properties of the QLQ-OES18 in a clinical trial population of patients with advanced or metastatic ESCC.</p><p><strong>Methodology: </strong>Analyses used data from RATIONALE 302 (NCT03430843), a randomized phase 3 study of tislelizumab versus investigator-chosen chemotherapy as second-line treatment for patients with advanced or metastatic ESCC. Psychometric validation of the QLQ-OES18 included tests of reliability, construct validity, ability to detect change, and estimation of anchor-based meaningful within-patient change (MWPC) thresholds-the latter two being exploratory given that the trial was not powered to detect efficacy in patient-reported outcome endpoints.</p><p><strong>Results: </strong>In total, 512 patients were randomized to either tislelizumab or chemotherapy; the average age was 61.5 years, and 84.4% were male. Three of the 4 QLQ-OES18 multi-item scales (dysphagia, eating, and pain) and the index scale met the prespecified criterion for acceptable internal consistency as well as acceptable test-retest reliability. Associations between baseline QLQ-OES18 scores and convergent/discriminant validators were generally as expected (i.e., the QLQ-OES18 pain score had a strong positive correlation with the QLQ-C30 pain score). For known-groups validity, 88.6% of analyses demonstrated the hypothesized direction of effect, suggesting that the expected differences in baseline QLQ-OES18 scores between prespecified groups were observed. Ability to detect change analyses indicated that several QLQ-OES18 domain scores demonstrated sensitivity in detecting possible treatment effects, although many patients reported minimal symptoms at baseline, which limited the ability to detect significant improvement.</p><p><strong>Conclusion: </strong>Overall, a collection of psychometric evidence indicated that the EORTC QLQ-OES18 reliably and validly measured symptom severity in the RATIONALE 302 population. Specifically, the dysphagia domain consistently demonstrated robust psychometric properties. Limitations in data reduced the interpretability of MWPC thresholds and are discussed in detail.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"56"},"PeriodicalIF":2.4,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12095746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144111248","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}