Journal of Patient-Reported Outcomes最新文献

{"title":"Predictors for non-response to PROMs across three areas of inpatient rehabilitation - a nationwide cross-sectional study in Switzerland.","authors":"Frederike Basedow, Gavin Brupbacher, Anke Scheel-Sailer, Thomas Sigrist, Jan Vontobel, Manuela Marquardt, Marie Utsch, Gaia Garuffi, Stephan Tobler, Anika Zembic","doi":"10.1186/s41687-026-01183-1","DOIUrl":"10.1186/s41687-026-01183-1","url":null,"abstract":"<p><strong>Background: </strong>Patient-reported outcome measures (PROMs) are valuable tools to integrate the patient perspective and improve quality of rehabilitation services. However, there is a risk of non-response bias. Identifying characteristics associated with non-response is important to reduce barriers to PROM completion and to ensure quality care for all patients undergoing rehabilitation.</p><p><strong>Methodology: </strong>In this cross-sectional observational study, we used routine data from the Swiss national quality assurance program for inpatient rehabilitation, in which PROMs are employed at admission and discharge for all patients in cardiac, psychosomatic and pulmonary rehabilitation. We included all patients aged 18 years or older, who completed cardiac, pulmonary or psychosomatic rehabilitation between 01.01.2016 and 31.12.2022. We used mixed-effects logistic regression to identify predictors for non-response to PROMs across the three areas of rehabilitation. Non-response was defined as recorded refusal to complete the PROMs (cardiac: MacNew Heart, psychosomatic: Hospital Anxiety and Depression Scale (HADS) and Patient-Health Questionnaire (PHQ)-15, pulmonary: Chronic Respiratory Disease Questionnaire CRQ) at admission and/or discharge. Several socio-demographic and medical characteristics, as well as clinic and year were included as covariates in the regression model.</p><p><strong>Results: </strong>We included 39,630 patients completing the MacNew Heart, 12751 HADS, 13195 PHQ and 16193 completing the CRQ. Non-response rates were highest for the MacNew Heart (28.6%) and CRQ (25.0%) and lower for the HADS (14.4%) and PHQ (17.5%). Across all three PROMs we observed strong significant associations of a nationality-based proxy for being a non-native speaker, admission from or discharge into a nursing home/rehabilitation and discharge into acute care after rehabilitation with non-response. Having no supplementary health insurance increased the odds for non-response on the MacNew Heart, HADS and CRQ. Additionally, higher comorbidity Cumulative Illness Rating Scale (CIRS) score and age were also significantly associated with non-response. Between-clinic differences explained a substantial proportion of variance in non-response, with adjusted ICCs ranging from 0.34 in psychosomatic to 0.62 in cardiac rehabilitation.</p><p><strong>Conclusion and relevance: </strong>Non-response to PROMs in rehabilitation is predicted by impaired health, older age, and a proxy for non-native language skills. This should be addressed by reducing barriers for patients with these characteristics to reduce bias and to ensure health equity.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148876088","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 the DIVAS-Q (Day-to-Day Impact of Vulvovaginal Atrophic Symptoms Questionnaire): a Portuguese patient-reported outcome measure.","authors":"Andreia Antunes, Patrício Costa, Ana Alves, Alexandra Colaço, Maria Guarino, Cristina Nogueira-Silva","doi":"10.1186/s41687-026-01172-4","DOIUrl":"10.1186/s41687-026-01172-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Portuguese is the fifth most spoken language worldwide. However, no validated patient-reported outcome measure (PROM) is available to assess the impact of vulvovaginal atrophy (VVA) symptoms in Portuguese-speaking women. This study aimed to culturally adapt and psychometrically validate the European Portuguese version of the Day-to-Day Impact of Vaginal Ageing questionnaire (DIVA), herein renamed DIVAS-Q (Day-to-Day Impact of Vulvovaginal Atrophy Symptoms Questionnaire), to reflect vulvovaginal atrophy Symptoms across different age groups. Also, deliberately broadened the conceptual scope for symptomatic adult women across reproductive stages in Portugal.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design and methods: &lt;/strong&gt;A multicentre observational study was conducted in Portugal, including pre- and post-menopausal women reporting at least one symptom of vulvovaginal atrophy. Participants were recruited from four clinical settings (public and private hospitals, private practice, and primary health care). Translation followed a standardised, multistep forward-backwards cultural adaptation protocol. Psychometric evaluation comprised descriptive analysis, confirmatory factor analysis (CFA) with WLSMV/DWLS estimation for ordinal indicators, internal consistency (Cronbach's alpha and McDonald's omega), item-total correlations, test-retest reliability using intraclass correlation coefficients (ICCs), convergent and discriminant validity, and known-groups validity based on the Vulvovaginal Symptom Questionnaire (VSQ) symptom-burden groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 291 women completed the short version (19 items), and 243 sexually active women completed the long version (23 items) of the DIVAS-Q. CFA with WLSMV/DWLS estimation supported the original four-factor structure (daily activities, emotional well-being, sexual function, and self-concept/body image) for both versions, with good model fit (scaled CFI/TLI = 0.981/0.978 and RMSEA = 0.027 for the short version; scaled CFI/TLI = 0.973/0.970 and RMSEA = 0.033 for the long version; SRMR = 0.035-0.040). Internal consistency was excellent across all domains (Cronbach's alpha = 0.856-0.960), with strong item-total correlations and average variance extracted values above recommended thresholds. Test-retest reliability was excellent (ICC = 0.982-0.994; 95% CIs consistently above 0.95). Known-groups validity was supported by significantly higher DIVAS-Q scores among women with higher VSQ symptom burden, with large effect sizes across domains.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The European Portuguese DIVAS-Q demonstrated good psychometric properties for assessing the day-to-day impact of vulvovaginal atrophy-related symptoms among symptomatic adult women in Portugal. The findings support its use in clinical and research contexts in Portugal, but further studies are needed before extending its use to other Portuguese-speaking populations or using it to monitor clinically meaningful ","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13486427/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148798965","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":"Development of the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19©) in immunocompromised and non-immunocompromised individuals and its validation in the EAGLE Study.","authors":"James C Marcus, Tiago Maia, Paul Williams, Renata T C Yokota, Sofie Arnetorp, Timothy A Herring, Sudhir Venkatesan, Philip A Powell, Johan L Hans Severens, James W Varni, Sylvia Taylor, Marieke Krol, John E Ware","doi":"10.1186/s41687-026-01150-w","DOIUrl":"10.1186/s41687-026-01150-w","url":null,"abstract":"<p><strong>Background: </strong>Many immunocompromised individuals continue to practice physical distancing behaviors to avoid severe COVID-19 outcomes. To measure the intensity of these physical distancing behaviors, we aimed to develop and validate a standardized metric across age groups: the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19©).</p><p><strong>Methodology: </strong>PDS-C19 development involved content scoping, initial draft PDS-C19 design phase, and exploratory testing (via asynchronous online forums). Psychometric properties (structural validity, reliability, and construct validity) of the PDS-C19 were evaluated using a random sample of immunocompromised and non-immunocompromised participants (n = 1059) of the EAGLE Study, including adults and children aged 0.5-17 years from the US and UK. Adult caregivers of children aged ≤ 12 years completed a proxy version of the PDS-C19 on their behalf, in addition to providing self-reported responses.</p><p><strong>Results: </strong>Findings from the two asynchronous forums (n = 23 and n = 22) indicated that the items identified in the scoping phase were relevant and well-understood. As part of the structural validity analysis, item-response distributions, inter-item correlations, and exploratory factor analyses supported a nine-item unidimensional intensity scale. Confirmatory factor analyses reduced the PDS-C19 to seven items (two items were dropped due to high residual correlations or differential item functioning by age). Internal consistency was high (ω = 0.97); convergent validity was good, with high correlations (r_max=0.74) with clinical outcome assessments of the ability to participate in activities and with worry. The PDS-C19 had good known-groups validity, with scores distinguishable by types of activities, level of worry, and number of close contacts.</p><p><strong>Conclusion: </strong>The PDS-C19 had acceptable structural and construct validity and high internal consistency, demonstrating its value as a measure of physical distancing to avoid COVID-19 in immunocompromised and non-immunocompromised individuals.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13525139/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148850859","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":"Self-reported perspective in rare genetic diseases: a systematic review of patient-reported outcome measures classified using the international classification of functioning, disability and health framework.","authors":"Rachele Simeon, Marina Usai, Alice Tramonti, Renata Canova, Daniela Frigerio, Anna Berardi, Elisa Pelosin, Carola Cosentino","doi":"10.1186/s41687-026-01155-5","DOIUrl":"10.1186/s41687-026-01155-5","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Rare and ultra-rare genetic diseases (GDs) involve complex, multidimensional burdens not fully captured by clinical endpoints, highlighting uncertainties in the availability, scope, and quality of Health-Related Quality-of-life patient-reported outcome measures (HRQoL-PROMs).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To identify PROMs developed or validated to assess HRQoL in rare and ultra-rare GDs, map their content using the International Classification of Functioning, Disability and Health (ICF), and evaluate their measurement properties according to COSMIN methodology.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Original studies reporting PROM development or measurement properties in rare or ultra-rare GDs were included. PubMed, Embase, PsycINFO, Web of Science, registries, outcome-measure repositories, reference lists, and citation tracking were searched from inception to March 26, 2026, without language restrictions. Study selection, data extraction, and risk-of-bias (RoB) assessment were performed independently. Methodological quality was evaluated using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) RoB checklist. Measurement properties were rated as sufficient, insufficient, indeterminate, or inconsistent, and certainty of evidence was assessed using a modified GRADE approach. PROM content was mapped to ICF components and synthesized narratively; no meta-analysis was conducted due to heterogeneity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Fifty-nine studies were included, covering 45 PROMs across 29 rare or ultra-rare GDs. Instruments were predominantly disease-specific, although generic and adapted measures were also identified. PROMs mainly addressed body functions and activities/participation, while environmental factors, social participation, stigma, and access-to-care domains were consistently underrepresented. Internal consistency and construct validity were most frequently assessed, whereas responsiveness, measurement error, and cross-cultural validity were rarely evaluated. Only three PROMs (HAE-QoL, NF1-AdQoL, EPP-QoL) were classified as COSMIN category A and recommended; most were category B, and five were category C.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;The evidence is limited and methodologically weak, and many QoL-PROMs fail to capture key multidimensional aspects of QoL; more rigorous, patient-centered, disease-specific development and validation are needed. This review examined questionnaires used to assess health related quality of life in people with rare and ultra-rare genetic diseases. Although 45 PROMs were identified, only three had enough evidence to be recommended. Many questionnaires focused mainly on symptoms and physical functioning, while important aspects such as social participation, stigma, care access, and environmental support were often missing. Future PROMs should be developed with strong patient involvement and validated across age groups, languages, and di","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13462012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148713799","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":"Identifying and understanding the health-related quality of life outcomes experienced by solid organ transplant recipients: a systematic review of qualitative research.","authors":"Ben Rimmer, Sarah Dickson, Siân Russell, Rebeka Jenkins, Dawn Craig, Linda Sharp, Catherine Exley","doi":"10.1186/s41687-026-01158-2","DOIUrl":"10.1186/s41687-026-01158-2","url":null,"abstract":"<p><strong>Purpose: </strong>This review aimed to identify and understand the health-related quality of life (HRQoL) outcomes experienced post-transplant by solid organ transplant recipients.</p><p><strong>Methods: </strong>We systematically searched MEDLINE, Embase, CINAHL, PsycINFO, and Scopus from inception to 17th May 2024. Search hits were independently screened, then study and sample characteristics were extracted from eligible papers, and transparency of reporting was appraised. A best fit framework synthesis was conducted to identify and map HRQoL outcomes to nine pre-defined HRQoL dimensions, and synthesise cross-cutting patterns in peoples' HRQoL experiences across studies.</p><p><strong>Results: </strong>We identified 40 papers reporting 39 qualitative studies of HRQoL in transplant recipients (kidney n = 14 studies, liver n = 10, heart n = 8, lung n = 3, mixed organs n = 4). Sample diversity (e.g. ethnicity, rurality) was lacking, or poorly reported, within and across included studies. Transparency of reporting was adequate. We identified 93 HRQoL outcomes; these could all be mapped to the nine HRQoL dimensions. The most commonly reported dimensions were emotional (n = 40 papers), social (n = 37), and role functioning (n = 35). Across solid organs, there were many common outcomes, encompassing positive and negative emotional impact, complex social and role challenges, and wide-ranging symptom distress.</p><p><strong>Conclusions: </strong>Solid organ transplant recipients experience extensive positive and negative HRQoL outcomes across every aspect of life, indicating where support may be required following transplantation. These findings inform a comprehensive and consolidated framework of the HRQoL outcomes experienced by transplant recipients. This provides valuable insights for the future development of transplant-specific patient-reported outcome measures, to ensure they comprehensively capture the HRQoL outcomes that are relevant to transplant recipients.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064902","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":"Higher severity of infant RSV infections is associated with lower parental quality of life - a European observational study.","authors":"Ilona Trautmannsberger, Sabina Bösl, Ina Adamek, Christian Apfelbacher, Philippe Beutels, Brigitte Essers, Ulrike Ravens-Sieberer, Catherine Weil-Olivier, Raffaella Nenna, Martin Wetzke, Silke Mader, Christina Tischer, Luc J I Zimmermann","doi":"10.1186/s41687-026-01157-3","DOIUrl":"10.1186/s41687-026-01157-3","url":null,"abstract":"<p><strong>Background: </strong>RSV infections in children affect the entire family. Nevertheless, evidence on the overall impact is scarce. This multi-country observational study aims to investigate the association between disease severity and health-related quality of life (HRQoL) in affected families and to explore the role of factors related to mental well-being.</p><p><strong>Methodology: </strong>Data were collected during the 2022-2023 RSV season in Germany, France, Italy and Sweden via an online questionnaire from parents of children (24 months) hospitalised for RSV. Parental HRQoL was assessed using the validated caregiver-reported PedsQL Family Impact Module. Exploratory analyses and multivariate linear regression models were performed focusing on potential key determinants.</p><p><strong>Results: </strong>A total set of 138 participants was assembled. Parents of children with a severe RSV infection had on average - 12.1 [95% CI: -21.2 to - 3.03; P = 0.010] lower HRQoL Summary Score than parents of children with low severity index scores. Subsequent stratified analyses revealed a stronger association among parents who had not been offered (adequate) mental health support.</p><p><strong>Conclusion: </strong>Higher RSV disease severity was associated with lower parental HRQoL. These findings highlight the importance of preventing severe RSV infection and the need for further research to identify and evaluate appropriate (psychosocial) support for affected families.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, identifier, NCT05550545. Registered 12 September 2022.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148593896","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":"Using intersectionality to inform fit-for-purpose patient-reported outcome measure development: a qualitative interview study.","authors":"Tilly Stott, Debbie Cavers, Kayla Ostrishko, Julia Lawton","doi":"10.1186/s41687-026-01132-y","DOIUrl":"10.1186/s41687-026-01132-y","url":null,"abstract":"<p><strong>Background: </strong>Patient-reported outcome measures (PROMs), often self-report questionnaires, capture a patient's health status as reported directly by the patient. PROMs are increasingly being used to collect patients' perspectives regarding health outcomes influencing their treatment and broader decisions about intervention efficacy, reimbursement, and service provision. Concerns are growing about how fit-for-purpose many PROMs are, with implications for health inequity. Health researchers are starting to explore how intersectionality can be used to understand health inequity, but intersectionality is rarely discussed in PROM development literature. This study sought to understand and explore PROM researchers' views about using intersectional approaches to develop fit-for-purpose PROMs.</p><p><strong>Methodology: </strong>Semi-structured interviews were conducted online with PROM researchers (n = 8) who both had and had not previously engaged with intersectionality. Interviews focused on perceived barriers to using intersectionality to inform PROM development and how such barriers could be overcome. With consent, interviews were recorded, transcribed and analysed using a reflexive thematic approach.</p><p><strong>Results: </strong>Participants reported limited understanding about intersectionality in the health outcomes field and how it can inform more fit-for-purpose PROM development. Concerns about methodological rigour in PROM development were also cited with participants noting that if existing shortcomings in how PROMs are developed are not recognised, it would be challenging to persuade researchers to change practices. Another challenge raised was reaching certain groups to participate in research, partly due to mistrust of medical research and healthcare professionals. Participants also expressed concerns about financial costs, noting that intersectional approaches may entail bigger budgets and longer study timelines. Participants likewise highlighted the role of the socio-political context in influencing what researchers could feasibly achieve. Interviewees from both groups proposed approaches to address barriers. These included garnering more diverse perspectives from research participants through community-based participatory research and establishing more diverse PROM development teams. They emphasised the value of clearly defining responsibility for instigating change. Participants finally outlined key arguments to help encourage stakeholders to support more intersectional approaches.</p><p><strong>Conclusions: </strong>Findings from this exploratory study suggest that despite considerable barriers, some PROM developers view intersectionality as a valuable framework for addressing existing PROM shortcomings. We provide tentative recommendations for encouraging PROM developers to use intersectionality to inform PROM development and measure health outcomes that are more meaningful to patients.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13612776/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149040932","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":"Cultural adaptation and preliminary psychometric assessment of the IMEVID questionnaire for assessing lifestyle in adults with type 2 diabetes in Peru.","authors":"Eduardo José Carcausto Huamaní, Angie Yajaira Nieto Olivera, Nelson Fidel Diaz Reyes","doi":"10.1186/s41687-026-01162-6","DOIUrl":"https://doi.org/10.1186/s41687-026-01162-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Multidomain patient-reported and self-reported instruments are often summarized using total scores, even when their domains represent conceptually distinct aspects of health behavior, emotional functioning, or self-management. Such scoring practices may obscure clinically meaningful domain-specific information if the instrument has not been shown to behave as a unidimensional reflective scale. This study culturally adapted the IMEVID questionnaire for use in Peru and evaluated its psychometric properties and score interpretation in adults with type 2 diabetes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a cross-sectional methodological study in 180 adults with self-reported type 2 diabetes in Peru. IMEVID underwent cross-cultural adaptation and expert-based content validity assessment. Psychometric evaluation included expert agreement for content validity, item and domain descriptive statistics, floor and ceiling effects, internal consistency estimates, Kaiser-Meyer-Olkin measures and Bartlett's tests based on Pearson and polychoric correlation matrices, exploratory factor analysis, confirmatory factor analysis, and hypothesis-driven Spearman correlations among domains. Cronbach's alpha was used for domains with three or more items, while inter-item Spearman correlations were used for two-item domains.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The adapted IMEVID showed high expert-based content validity agreement across clarity, coherence, relevance, and sufficiency criteria, with an overall mean agreement of 0.96 and acceptable overall internal consistency (α = 0.82). Domain-level internal consistency varied across the instrument, with Cronbach's alpha ranging from 0.43 to 0.78 and two-item domain correlations ranging from 0.26 to 0.74. Factorability assessment differed according to the correlation matrix: the Pearson matrix showed acceptable sampling adequacy (KMO = 0.757), whereas the polychoric matrix yielded a very low KMO value (KMO = 0.14), likely influenced by sparse response patterns and marked ceiling effects in selected domains. Exploratory factor analysis was more consistent with a seven-factor solution aligned with the original IMEVID domains. Confirmatory factor analysis showed poor fit for the one-factor model (CFI = 0.677; TLI = 0.648; RMSEA = 0.104; SRMR = 0.151) and substantially better fit for the seven-domain model (CFI = 0.946; TLI = 0.936; RMSEA = 0.044; SRMR = 0.093). All standardized factor loadings in the seven-domain model were statistically significant.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The Peruvian adaptation of IMEVID showed high content validity agreement, acceptable overall reliability, and preliminary structural support for the original seven-domain organization. The findings were more consistent with a multidomain lifestyle assessment tool than with a strictly unidimensional reflective scale. Domain scores may provide complementary information about distinct aspects of lifestyle and self-m","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13631132/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149115941","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":"Impact of translation availability on the patient voice in clinical trials: commentary.","authors":"Dagmara Kuliś, Sonya Eremenco, Lindsay Hedderly, Diane E Leek, Ana A Popielnicki, Emily Potz","doi":"10.1186/s41687-026-01156-4","DOIUrl":"10.1186/s41687-026-01156-4","url":null,"abstract":"<p><p>For clinical outcome assessments (COAs) to be used in global clinical trials, they must be developed in the native language of participants through the process of linguistic validation (LV). This commentary discusses why ensuring linguistic coverage might be difficult for sponsors and what consequences a lack of translated COAs might have on study data. Access to translations might be challenging due to issues with the licensing of available translations, incorporating translation development processes into study timelines, or not foreseeing language needs of each study during the planning phase. In consequence, poor quality translations might be used, or certain countries or regions might not be included at all, leading to missing data and limitations to the results of the study. To prevent these negative consequences to study data, COAs should be included in the study planning as early as possible, giving all stakeholders adequate time to fulfill any licensing requirements as well as to properly develop measures in other languages to ensure conceptual equivalence and data comparability to support pooling of data across countries. By improving communication and expectations across stakeholders involved in the licensing and translation of COAs for clinical trials, translations will be more widely available for the participants who need them, increasing the presence of the patient voice in clinical trials.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"10 1","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13388571/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148537331","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":"Using electronic patient reported outcomes (ePROs) to improve supportive care in ambulatory oncology care: a CFIR-guided pre-implementation formative evaluation.","authors":"Eden R Brauer, Roshan Bastani, Eric Cheng, Stephanie Lazaro, Deborah J Wong, Maie A St John, Patricia A Ganz","doi":"10.1186/s41687-026-01144-8","DOIUrl":"10.1186/s41687-026-01144-8","url":null,"abstract":"<p><strong>Background: </strong>Systematic collection of patient-reported outcomes via electronic health records can improve symptom assessment and supportive care delivery in oncology, yet implementation is often hindered by inadequate attention to end-user needs and organizational context. Guided by an implementation science framework, we conducted a formative evaluation to inform design and implementation planning of an electronic patient-reported outcome supportive care screening system in ambulatory oncology care, using head and neck cancer as a use case.</p><p><strong>Methods: </strong>A prospective mixed-methods observational study was conducted using semi-structured interviews as part of a pre-implementation formative evaluation. Eligible participants were target users of the proposed supportive care screening system, including (1) clinical staff and (2) patients with head and neck cancer from a single health care system. Using the Consolidated Framework for Implementation Research as a guiding framework, we elicited user feedback through interview and prototype engagement. Quantitative measures included patient symptom burden and validated pre-implementation measures of acceptability, appropriateness, feasibility, and usability. For data analyses, we used directed content analysis and matrix analysis for qualitative data, and descriptive and comparative statistics for quantitative assessments.</p><p><strong>Results: </strong>Forty-six target users (20 clinical staff, 26 patients) participated. Both groups expressed strong tension for change, recognizing many inadequacies of the current approach to symptom assessment. Clinical staff described current practices as \"haphazard,\" while patients recounted missed opportunities for support and preventable harm. Electronic health record integration enhanced perceived compatibility, though time constraints and alert fatigue emerged as potential barriers. Clinical staff emphasized the need for clear symptom thresholds and actionable referral criteria; patients emphasized that their sustained engagement depended on evidence of clinicians using the data in their care. Pre-implementation scores indicated strong readiness across both groups: acceptability (clinical staff 4.47/5, patients 4.21/5), appropriateness (4.46/5, 4.24/5), feasibility (4.41/5, 4.35/5), and usability (82.2/100, 85.6/100). Findings informed key design priorities and implementation strategies.</p><p><strong>Conclusions: </strong>Systematic pre-implementation formative evaluation revealed important barriers, facilitators, and contextual insights that shaped both intervention design and implementation approach. High scores on leading indicators suggest strong organizational readiness and perceived value. This user-informed development process provides a replicable model for optimizing electronic patient-reported outcome systems before deployment.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148537291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}