The Work Disability Functional Assessment Battery (WD-FAB) was developed based on the International Classification of Functioning, Disability and Health (ICF) framework and administered using a computer adaptive test (CAT) to assess individuals’ functional status. The framework and assessment of functional status is especially pertinent in Germany as one factor in determining work disability. This paper reports on the translation and cultural adaptation of the WD-FAB from English (USA) to German (Germany). A combination of forward-backward and dual-panel approaches was used to translate the WD-FAB into German. During the reconciliation process after forward and backward translations, a selection of items was discussed with the forward/backward certified translators, discussed with developers of the WD-FAB and selected for dual-panel discussion. A field test with rehabilitation patients was conducted to finalize the adaptation. 401 unique items from the original WD-FAB and version 3.0 (the majority of the items were the same across versions) were translated into German. After forward translation, the majority of the items were easily reconciled. Some items (identified by YF and TK) could not be easily reconciled and required additional examination. Based on the reasons for difficulties in forward translation, items were selected for the translation panel discussions (n = 69), discussed with developers (n = 49) and/or further discussed with the two forward translators (n = 18). After the first reconciliation and backward translation, 31 items were discussed with all translators again and 4 were again discussed with developers. 77 rehabilitation patients participated in the field test, 29 of whom provided feedback suggesting further revisions. Through the entire adaptation process, the items that were problematic involved those dealing with “anger” and “stress”. Furthermore, environmental differences between Germany and the USA limited the adaptation of some physical functioning items. Despite some differences in the cultural and structural context, we successfully adapted the WD-FAB item banks to German. Future validation of the measure is necessary to understand whether the items have similar psychometric measurement properties to those of the original WD-FAB.
The aim of this study was to conduct a comprehensive analysis of the item-level psychometric properties of the Spanish EQ-5D-5L questionnaire in patients with hip or knee osteoarthritis (OA) using item response theory. The study included 758 patients with hip or knee OA who completed the EQ-5D-5L questionnaire. The EQ-5D-5L contains five questions (mobility (MOB), self-care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD)) from which a utility index is derived. A complete validation was performed, including graded response modelling to study item functioning and the assessment of differential item functioning considering sex and affected joint. The graded response model results showed that all items were good at discriminating the latent trait. Items on MOB and UA had the greatest discriminating power, also covering the widest range of the trait. AD item had the least discriminating power and was the one that covered the narrowest range of the trait. PD item was more apparent at lower levels of severity and SC item at higher levels. Some degree of sex-related differential item functioning was detected in AD item, being somewhat more apparent at higher levels of severity in males than females. The graded response model results support the adequate functioning of all the items on the EQ-5D-5L in these patients, providing more evidence of its validity in OA. Therefore, the EQ-5D-5L could be of interest in clinical research and routine practice in the orthopaedic community for measuring health-related quality of life.
Postpartum sleep is a unique construct, and existing sleep patient-reported outcome measures (PROMs) do not adequately address some of its fundamental domains. We aimed to develop postpartum-specific extension items to the PROMIS Sleep Disturbance (SD) and Sleep Related Impairment (SRI) item banks. The postpartum-specific SD and SRI items were developed to add to the existing PROMIS SD and SRI item banks. Postpartum-specific PROMIS items were generated based on findings from literature characterizing postpartum sleep, including systematic reviews and qualitative interviews with patients and experts from diverse specialties. The candidate items were subsequently iteratively adapted and selected through a modified Delphi process involving a panel of 21 stakeholders including experts in obstetrics, sleep, psychiatry, patients and partner representatives. Items achieving consensus with ≥ 70
This study presents the development of a glossary designed to harmonize terminology, foster consensus and support the successful implementation of the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) guidelines. SISAQOL-IMI consortium representatives from 41 international organisations were invited to participate in the development of the glossary. From 2021 to 2024, the glossary was developed through iterative processes, guided by consortium members input and formally updated twice yearly. A template with categories for term, acronym, topic, scientific definition, plain language definition, examples and references/sources was applied and were accessible for input throughout the process. As project documents such as draft guideline recommendations were updated, new terms for the glossary were identified. Definition of terms were primarily sought from a predefined hierarchical list of references and acknowledged resources, such as existing glossaries, prior to seeking other references. Patient representatives and patient advocates from The Workgroup of European Cancer Patient Advocacy Networks contributed to plain language definitions. The glossary development resulted in 227 terms with scientific and plain language definitions, which are integrated into the online SISAQOL-IMI guidelines. During the initial development phase, of 205 terms, the project’s work package teams agreed on 166 (81
Most screening tools for prescription analgesic misuse were developed in high-opioid prescribing contexts. This study evaluated the measurement properties and screening utility of the Japanese version of the PROMIS Prescription Pain Medication Misuse–Short Form 7a (PROMIS Rx Misuse 7a) in a strictly regulated, low-opioid prescribing environment. A cross-sectional web-based survey was conducted among 500 Japanese adults with chronic pain who were currently prescribed analgesics. The sample was randomly divided into an exploratory subsample (n = 250) and an independent confirmatory subsample (n = 250). Structural validity was evaluated using exploratory factor analysis (EFA), parallel analysis, confirmatory factor analysis (CFA), and item response theory (IRT). Reliability was assessed using internal consistency and test–retest methods. Construct validity was examined through correlations and structural equation modeling using hypothesis testing based on expected patterns of association. Screening performance was evaluated using receiver operating characteristic analysis, with the Severity of Dependence Scale (SDS) as an external reference criterion for elevated psychological dependence risk. Independent-sample EFA, parallel analysis, and CFA supported a predominantly unidimensional structure, although RMSEA remained elevated. Internal consistency was acceptable to good (Cronbach’s α = 0.79; McDonald’s ω = 0.80), whereas test–retest reliability was moderate (ICC = 0.61; 95
Interpreting meaningful change in patient-reported outcome measures (PROMs) is essential for assessing hip replacement outcomes. The Oxford Hip Score (OHS) is widely used, yet statistically detectable change may not align with patient-perceived improvement. To compare Rasch-based classifications of OHS change, following Hobart’s effect size methodology, with anchor-based interpretations derived from patient Global Impression of Change (GIC). OHS data from a large hip replacement cohort (N = 184,509) were analysed using two complementary approaches. Rasch analysis transformed ordinal scores into interval-level person measures, and effect sizes with confidence intervals classified patients as significantly improved, non-significantly improved, unchanged, or worse. MIC was estimated using a five-point patient GIC. Median pre-operative, post-operative, and change scores were summarised per category. Both methods demonstrated graded outcome patterns. Concordance was strongest for large improvements, with statistically significant change closely matching reports of being “much better.” Divergence occurred for modest improvement and worsening: patients often reported little or no benefit despite measurable OHS improvement. Rasch-based and anchor-based approaches capture overlapping but distinct constructs. Integrating both provides a nuanced interpretation of PROM change after hip replacement.
The howRwe questionnaire is a brief measure of patient experience that has not been adapted for Persian-speaking populations. This study aimed to translate, culturally adapt, and psychometrically validate the Persian version of the howRwe questionnaire (P-howRwe). This single-center cross-sectional study was conducted in two phases: translation/cultural adaptation and psychometric validation. Following forward and backward translation, an expert committee reviewed the translated version and produced a pre-final Persian version, which was refined through pilot testing. Psychometric properties were evaluated in 200 inpatients in Tehran, Iran. Test-retest reliability was assessed in 50 patients over a 5- to 7-day interval. Internal consistency was assessed using Cronbach’s alpha, content validity using the content validity ratio (CVR) and content validity index (CVI), and concurrent validity using the Persian SERVQUAL questionnaire. Construct validity was assessed by exploratory factor analysis and mirror exploratory factor analysis in two random subsamples. The Persian version showed good acceptability, with no reported comprehension difficulties during pre-final testing. The mean total P-howRwe score was 10.62 ± 1.32 (range 1–12). It demonstrated satisfactory reliability (Cronbach’s α = 0.84; McDonald’s ω = 0.86; ICC = 0.80, 95
The balloon guide catheter may improve technical aspects of endovascular thrombectomy (EVT) for acute ischemic stroke (AIS) with large vessel occlusion, but the parent PROTECT-MT trial did not show better clinical outcomes with balloon guide catheter use. Whether these clinical findings are reflected in patient-reported health-related quality of life (HRQoL) remains uncertain. In this multicenter, open-label, blinded-endpoint trial across 28 hospitals in China, 329 patients with anterior circulation large vessel occlusion were randomized 1:1 to EVT with a balloon guide catheter or a conventional guide catheter. HRQoL was assessed cross-sectionally at 90 days using the EuroQol 5-dimension 5-level (EQ-5D-5L) descriptive system and the Chinese value set to derive EQ-5D-5L index values; disability was assessed using the modified Rankin Scale (mRS). Quantile regression and logistic regression models examined treatment effects on the EQ-5D-5L index and its five domains, with prespecified interactions by age and gender. Sensitivity analyses excluded deaths and imputed missing values using truncated regression. HRQoL at 90 days was lower with balloon guide catheter versus conventional guide catheter use (median EQ-5D-5L index, 0.27 vs. 0.73), with the clearest adjusted contrast observed among patients aged 60–79 years (adjusted difference − 0.27; 95
Dyspnea is a prominent symptom in patients with warm autoimmune hemolytic anemia (wAIHA), yet its lived experience remain under-researched. Although clinically relevant, dyspnea is not routinely assessed in wAIHA trials, and no validated patient-reported outcome (PRO) measures exist for this population. This study explored patients’ experience of wAIHA-related dyspnea, identified its most bothersome impacts on daily life, and evaluated the content validity of the FACIT-Dyspnea 10-item Short Form (SF) in wAIHA. Hybrid concept elicitation and cognitive debriefing interviews were conducted with 15 adults diagnosed with wAIHA in the US. Patients were recruited via recruitment vendors and a patient advocacy group. Interviews were conducted online, transcribed verbatim, and analyzed using inductive and deductive coding. All fifteen patients (aged 35–74; 80
Heart failure is a chronic and progressive cardiovascular condition that substantially impairs physical, emotional, and social functioning, resulting in reduced health-related quality of life (HRQoL). In Ethiopia, individual studies report a high burden of poor HRQoL among heart failure patients; however, there has been no comprehensive synthesis quantifying its overall magnitude or identifying consistent associated factors. To estimate the pooled prevalence of poor HRQoL and identify associated factors among patients with heart failure in Ethiopia. A systematic review and meta-analysis was conducted following PRISMA 2020 guidelines and registered in PROSPERO (CRD420261323503). Electronic databases including PubMed/MEDLINE, Scopus, Embase, Web of Science, African Journals Online, and Google Scholar were searched. Observational studies conducted in Ethiopia reporting HRQoL using validated tools were included. Data were analyzed using STATA version 17.0. A random-effects model was applied. Heterogeneity was assessed using Cochran’s Q and I² statistics. Publication bias was evaluated using funnel plot and Egger’s test. Seven studies involving 2,396 patients were included. The pooled prevalence of poor HRQoL was 47.82
Abstract Introduction 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. Design and methods 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. Results 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. Conclusions 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 change over time.
To systematically compare pain outcomes associated with labial and lingual fixed orthodontic appliances in patients undergoing active orthodontic treatment. A systematic review was conducted following PRISMA guidelines. Randomized clinical trials, prospective clinical controlled trials and retrospective observational studies reporting patient-reported pain were included. Databases searched included PubMed, Scopus, Web of Science, Cochrane Library, and EBSCO. Pain intensity, localization, and functional impact were extracted, and methodological quality was assessed using the Cochrane Risk of Bias 2.0 tool and Newcastle–Ottawa Scale. Due to heterogeneity in pain instruments, timing, and appliance design, meta-analysis could not be performed, and evidence certainty was evaluated using GRADE. Thirteen studies involving 775 participants, of whom 554 underwent direct comparison between labial and lingual orthodontic treatment, were included. Pain peaked within 24–48 h post-appliance placement and declined within 7–14 days. Lingual appliances were associated with tongue pain in 94.4
Although patient-reported data are increasingly available and their usefulness is recognized, these measures are not well integrated at the clinical levels of primary care. Also, the processes through which these data are translated into actionable insights for quality improvement remain insufficiently described and theorized. This study aimed to assess the feasibility and acceptability of a two-component intervention to support primary care clinics in meaningful quality improvement. We developed an intervention designed for primary care clinics, utilizing dashboards that present practice-level data on PROMs and PREMs collected during the Patient-Reported Indicators Survey (PaRIS) study in the province of Quebec, Canada, combined with reflective sessions. The intervention combined clinic-specific PROMs/PREMs dashboards with facilitated reflective sessions to support data interpretation and quality improvement planning. We conducted a convergent mixed-methods study combining multiple sources of data (questionnaires, logbooks, and summary reports) to explore the seven components of Acceptability of the intervention, as defined by Sekhon et al. (Affective Attitude, Burden, Ethicality, Intervention Coherence, Opportunity Costs, Perceived Effectiveness, and Self-Efficacy). Between September 2024 and April 2025, we conducted the intervention in ten clinics, and 152 participants attended one of the reflective sessions. A high proportion of participants provided positive feedback to the Affective Attitude- and Intervention Coherence-related measured items. Participants reported that the intervention had a good fit with their individual value system and was useful. The average scores for intention and confidence in making a change in their practice post-intervention were high (respectively, 7.82/10 (SD = 1.43) and 8.13/10 (SD = 1.42)). Most participants indicated that the intervention improved their understanding of PROMs and PREMs and supported their use, helped identify clinic strengths and areas for improvement, and facilitated the prioritization of improvement targets. Participants proposed concrete strategies for planning practice changes related to chronic pain management, financial precarity, service utilization, training and mentorship, among other areas. The burden was judged acceptable, despite some participants raising concerns, such as technological issues. This study demonstrates the feasibility of translating aggregated group-level patient-reported data into actionable tools that support quality improvement and service reorganization in primary care. Returning these data to practices contributes to the core goals of value-based care by aligning professional practice, organizational processes, patient priorities, and system objectives.
Systemic sclerosis (SSc) is a chronic autoimmune disease characterized by fibrosis and visible skin changes that often result in body image dissatisfaction and impaired quality of life. Despite this, appearance-related concerns remain under-investigated in SSc. The Brief Satisfaction with Appearance Scale (Brief-SWAP) is a concise, validated instrument designed to assess body image dissatisfaction and social discomfort in individuals with visible disfigurement due to SSc. To adapt and validate the Brief-SWAP scale into Hungarian using internationally accepted methodology. Sixty patients with systemic sclerosis (53 women, 7 men; mean age 57.7 ± 13.5 years; 51.7
Parkinson’s disease (PD) substantially affects health-related quality of life (HRQoL). The EQ-5D-5 L is a preference-based patient-reported outcome measure that supports cross-condition comparison and health-economic evaluation, but its measurement properties have not been established in people with PD in Italy. This study evaluated short-term reproducibility and construct validity through a priori hypothesis testing; score distributions and inter-dimensional associations were also described. This cross-sectional psychometric study included a 48-hour retest component. Participants completed the EQ-5D-5 L, the Parkinson’s Disease Questionnaire-39 (PDQ-39), and the 12-item Short Form Health Survey (SF-12). Short-term reproducibility was assessed using quadratic-weighted Cohen’s kappa and exact agreement for the five dimensions and single-measures, two-way random-effects, absolute-agreement intraclass correlation coefficients for the EQ-Index and EQ-VAS. Construct validity was examined using prespecified directional and magnitude hypotheses tested with Spearman correlations; Pearson correlations were used as sensitivity analyses. Post hoc analyses examined routine-care clinical measures and ordered motor-severity categories. Eighty participants completed the questionnaires, and 60 underwent retesting. Fifty-nine distinct health states were observed, with one participant reporting full health. Agreement was high for the EQ-Index (ICC = 0.901, 95
Oral symptoms are common among patients with different types of cancer and cancer sites. Patient report is the gold-standard in symptom management, and no multi-oral symptom assessment instrument is yet available for the Portuguese patients with advanced cancer. This study aimed to translate the Oral Symptom Assessment Scale (OSAS) into Portuguese, evaluate the structural validity of the Portuguese version and its psychometric properties. A methodological, quantitative, descriptive, multicentred, cross-sectional study was conducted. The translation, cross-cultural adaptation and structural validity procedures followed COSMIN guidelines. The original instrument was translated to Portuguese, and the final translated version was pre-tested in a sample of 30 patients with advanced (locally or metastatically) and incurable cancer, and an estimated survival of months. The final translated version was then administered to a sample of 101 patients with advanced (locally or metastatically) and incurable cancer, and an estimated survival of months, attending oncology outpatient consultations or receiving hospital-based palliative care. Three hypothesised factor structures were analysed using confirmatory factor analysis, in accordance with COSMIN guidelines. The Portuguese version of the OSAS was well understood, accepted, and considered relevant and feasible by the participants. A three-factor model with 17 items was retained, demonstrating good overall fit ( scaled CFI=0.979 ; SRMR=0.067 ; RMSEA=0.060 , CI 95% [0.033, 0.082] p = .244 ). No inadmissible parameter estimates were identified in the three-factor model. All factor loadings were statistically significant and within acceptable ranges (0.57 to 0.98). Evidence supports a three-factor structure model, as the most appropriate representation of the instrument’s latent structure in this population, consisting of changes in oral functions, changes in oral mucosa, and dental changes. The Portuguese version of the OSAS demonstrated good structural validity and reliability and appears suitable for research and clinical use in Portuguese patients with advanced cancer.
This longitudinal designed study evaluated the impact of systemic isotretinoin use on oral health-related quality of life (OHRQoL) through its effects on clinical periodontal parameters, salivary flow rate, and patient-reported oral symptoms. Twenty-four periodontally healthy patients who prescribed systemic isotretinoin for acne vulgaris treatment were enrolled. Sociodemographic data, patient-reported oral symptoms and periodontal parameters were recorded, salivary flow rate (SFR) calculated and oral health-related quality of life assessed through OHIP14-TR scales at 4 different timepoints: before (T0), at the 6th week (T1), at the 5th month (T2), and after the completion (T3) of isotretinoin treatment. Friedman test was used to compare data between each follow up and Generalized Estimating Equations (GEE) were utilized to identify the associations between clinical parameters and OHRQoL scores. P-values of < 0.05 was considered statistically significant. Isotretinoin use led to a transient increase in self-reported salivary dryness (T1:66.7
Protective parental behavior is crucial for children’s safety and emotional well-being, but excessive protection may hinder their autonomy. This issue is particularly relevant for caregivers of children with chronic or rare diseases, who may adopt heightened protective behaviors. The Parent Protection Scale (PPS) is a validated patient-reported tool for assessing parental overprotection. Given Korea’s unique cultural context, which emphasizes close family ties, this study aimed to translate and validate PPS for Korean populations. A total of 179 caregivers of pediatric patients aged 5–10 years with cancer or rare diseases were recruited from eight hospitals across Korea between August 2023 and December 2024. The PPS was translated into Korean through a forward-backward translation process. Exploratory factor analysis (EFA) with principal axis factoring and direct oblimin rotation was performed to examine the factor structure. Internal consistency was assessed by Cronbach’s alpha, and concurrent validity was evaluated using Pearson correlation with questionnaires for anxiety, depression, and social support measures. EFA revealed a four-factor structure, which differed from that of the original PPS subscales—strict behavioral control, emotional intrusiveness, anxious ambivalence, and autonomy restriction—accounting for 44.85
Patient-Reported Experience Measures (PREMs) are validated self-reported perceptions of how patients experience care in a given context. Despite their recognized value, their integration in clinical settings is limited by conceptual heterogeneity and measurement inconsistency. To enhance comparability and operational clarity, this study aimed to develop a consensus-based core set of constructs representing the essential dimensions of patient experience in primary care. We conducted a three-round Delphi study in accordance with the COS-STAD and ACCORD methodological standards. We purposively recruited experts into three groups: patients, clinicians/decision-makers, and researchers. Sixteen constructs derived from a prior scoping review of validated PREMs were rated for inclusion in a core measurement set. Consensus thresholds were defined a priori as a positive median, interquartile range < 1, and < 5
Quality of life measures are important for understanding child well-being, particularly in low- and middle-income countries where linguistic and cultural differences can limit the use of standardized tools. Although the PedsQL 4.0 Generic Core Scales (GCS) for Infants is widely used, no Kiswahili translation exists for infants in Kenya. This study aimed to culturally adapt the PedsQL 4.0 GCS for use in western Kenya. Cultural adaptation followed Mapi Research Institute guidelines. Two bilingual translators independently completed forward translations, which were reconciled into a Kiswahili version. A third translator conducted backward translation, with discrepancies resolved by a multidisciplinary committee. Cognitive interviews were conducted with nine bilingual caregivers using the adapted 13–24 month scale to assess comprehension and cultural relevance. Feedback was used to revise wording and ensure conceptual equivalence. Identical changes were applied to the 1–12 month scale. Nine caregivers (89
