Journal of Patient-Reported Outcomes最新文献

{"title":"General population normative values for the EORTC QLQ-C30 by age, sex, and health condition for the French general population","authors":"Micha J. Pilz, Fanny L.C. Loth, Sandra Nolte, Anna M.M. Thurner, Eva-Maria Gamper, Amélie Anota, Gregor Liegl, Johannes M. Giesinger","doi":"10.1186/s41687-024-00719-7","DOIUrl":"https://doi.org/10.1186/s41687-024-00719-7","url":null,"abstract":"General population normative values for the widely used health-related quality of life (HRQoL) measure EORTC QLQ-C30 support the interpretation of trial results and HRQoL of patients in clinical practice. Here, we provide sex-, age- and health condition-specific normative values for the EORTC QLQ-C30 in the French general population. French general population data was collected in an international EORTC project. Online panels with quota samples were used to recruit sex and age groups. Number and type of comorbidities were assessed. Descriptive statistics were used to calculate general population values for each QLQ-C30 scale, separately for sex, age, and presence of one- and more chronic health conditions. A multivariate linear regression model has been developed to allow estimating the effect of sex, age, and the presence for one- and more chronic health conditions on EORTC QLQ-C30 scores. Data was weighted according to United Nation statistics adjusting for the proportion of sex and age groups. In total, 1001 French respondents were included in our analyses. The weighted mean age was 47.9 years, 514 (51.3%) participants were women, and 497 (52.2%) participants reported at least one health condition. Men reported statistically significant better scores for Emotional Functioning (+9.6 points, p = 0.006) and Fatigue (−7.8 point; p = 0.04); women reported better profiles for Role Functioning (+8.7 points; p = 0.008) and Financial Difficulty (−7.8 points, p = 0.011). According to the regression model, the sex effect was statistically significant in eight scales; the effect of increasing age had a statistically significant effect on seven of the 15 EORTC QLQ-C30 scales. The sex- and age effect varied in its direction across the various scales. The presence of health conditions showed a strong negative effect on all scales. This is the first publication of detailed French normative values for the EORTC QLQ-C30. It aims to support the interpretation of HRQoL profiles in French cancer populations. The strong impact of health conditions on QLQ-C30 scores highlights the importance of considering the impact of comorbidities in cancer patients when interpreting HRQoL data.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140831763","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}

{"title":"The evaluation of goal-directed activities to promote well-being and health in heart failure: EUROIA scale","authors":"Robert P. Nolan, Fatima Syed, Nicolette Stogios, Robert Maunder, Sanjeev Sockalingam, E. Shyong Tai, Mark Cobain, Rachel G. Peiris, Ella Huszti","doi":"10.1186/s41687-024-00723-x","DOIUrl":"https://doi.org/10.1186/s41687-024-00723-x","url":null,"abstract":"The EvalUation of goal-diRected activities to prOmote well-beIng and heAlth (EUROIA) scale is a novel patient-reported measure that was administered to individuals with chronic heart failure (CHF). It assesses goal-directed activities that are self-reported as being personally meaningful and commonly utilized to optimize health-related quality of life (HRQL). Our aim was to evaluate psychometric properties of the EUROIA, and to determine if it accounted for novel variance in its association with clinical outcomes. This study was a secondary analysis of the CHF-CePPORT trial, which enrolled 231 CHF patients: median age = 59.5 years, 23% women. Baseline assessments included: EUROIA, Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS), Patient Health Questionnaire–9 for depression (PHQ-9), and the Generalized Anxiety Disorder–7 (GAD-7). 12-month outcomes included health status (composite index of incident hospitalization or emergency department, ED, visit) and mental health (PHQ-9 and GAD-7). Exploratory Principal Axis Factoring identified four EUROIA factors with satisfactory internal reliability: i.e., activities promoting eudaimonic well-being (McDondald’s ω = 0.79), social affiliation (⍺=0.69), self-affirmation (⍺=0.73), and fulfillment of social roles/responsibilities (Spearman-Brown coefficient = 0.66). Multivariable logistic regression indicated that not only was the EUROIA inversely associated with incidence of 12-month hospitalization/ED visits independent of the KCCQ-OS (Odds Ratio, OR = 0.95, 95% Confidence Interval, CI, 0.91, 0.98), but it was also associated with 12-month PHQ-9 (OR = 0.91, 95% CI, 0.86, 0.97), and GAD-7 (OR = 0.94, 95% CI, 0.90, 0.99) whereas the KCCQ-OS was not. The EUROIA provides a preliminary taxonomy of goal-directed activities that promote HRQL among CHF patients independently from a current gold standard state-based measure. NCT01864369; https://classic.clinicaltrials.gov/ct2/show/NCT01864369 .","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140808881","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}

{"title":"Exploring patients' experience using PROMs within routine post-discharge follow-up assessment after stroke: a mixed methods approach.","authors":"B. M. P. Mourits, S. J. den Hartog, J. D. de Graaf, B. Roozenbeek, M. W. M. Post, J. M. A. Visser-Meily, E. W. Scholten","doi":"10.1186/s41687-024-00724-w","DOIUrl":"https://doi.org/10.1186/s41687-024-00724-w","url":null,"abstract":"","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140652707","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}

{"title":"Qualitative interviews of patients with COPD and muscle weakness enrolled in a clinical trial evaluating a new anabolic treatment: patient perspectives of disease experience, trial participation and outcome assessments","authors":"Maggie Tabberer, Nicola Williamson, Sophi Tatlock, Adam Gater, Rebecca Grimes, Chika Akinseye, David Neil, Aoife Mahon-Smith, Linda Nelsen","doi":"10.1186/s41687-024-00712-0","DOIUrl":"https://doi.org/10.1186/s41687-024-00712-0","url":null,"abstract":"Chronic obstructive pulmonary disease (COPD) and muscle weakness can cause impaired physical function, significantly impacting patients’ health-related quality of life (HRQoL). Loss of muscle strength is usually assessed through clinical and performance outcome (PerfO) assessments, which consists of tasks performed in a standardized manner, providing evidence of a patient’s functional ability. However, evidence documenting the patient experience of COPD and muscle weakness is limited. This two-stage qualitative study used semi-structured interviews in patients aged 45–80 years with COPD (post-bronchodilator forced expiratory volume in 1s [FEV1]/forced vital capacity ratio < 0.70, and FEV1% predicted of 30–80%) and muscle weakness. In Stage 1, 30-minute concept elicitation interviews were conducted with participants recruited across three US sites to explore impacts on physical functioning and activities of daily living. In Stage 2, interviews were performed with participants exiting a Phase IIa trial investigating the efficacy of a selective androgen receptor modulator (GSK2881078) on leg strength, whereby PerfOs were used to evaluate strength and physical functioning endpoints. These participants completed either 60-minute in-depth (n = 32) or 15-minute confirmatory (n = 35) interviews exploring trial experience, completion of outcome measures, disease experience and treatment satisfaction. In Stage 1 (n = 20), most participants described their muscles as weak (83.3%). Difficulties with walking (100%) and lifting heavy objects (90%) were reported. In Stage 2, 60-minute interviews, all participants (n = 32) reported a positive trial experience. Most participants reported that the home exercise program was easy to fit into daily life (77.8%), the PROactive daily diary was easy to complete (100%) and wearable sensors were easy to use (65.6%). However, technical issues were reported (71%), and few participants (19.4%) found physical assessments easy to complete. Improvements in muscle strength and functional limitations were reported by most participants. The shorter 15-minute confirmatory interviews (n = 35) supported the in-depth interview results. The qualitative interviews generated in-depth evidence of key concepts relevant to patients with COPD and muscle weakness and support the assessments of patient strength and physical function as outcome measures in this population in future studies. GSK Stage 1: 206869; Stage 2: 200182, NCT03359473; Registered December 2, 2017, https://clinicaltrials.gov/ct2/show/NCT03359473 .","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140626161","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}

{"title":"Development and validation of a Context-sensitive Positive Health Questionnaire (CPHQ): A factor analysis and multivariate regression study","authors":"Brian M. Doornenbal, Tim van Zutphen, Lise F. E. Beumeler, Rimke C. Vos, Mark Derks, Hinke Haisma, M. Elske van den Akker-van Marle, Jessica C. Kiefte-de Jong","doi":"10.1186/s41687-024-00718-8","DOIUrl":"https://doi.org/10.1186/s41687-024-00718-8","url":null,"abstract":"The concept of Positive Health (PH) has gained increasing attention as a way of measuring individuals’ ability to adapt in the face of contextual challenges. However, a suitable measurement instrument for PH that encompasses contextual factors has not yet been developed. This paper responds to this need by developing a Context-specific Positive Health (CPH) measurement instrument that aligns with the Capability Approach (CA). The measurement instrument was developed and tested among a representative sample of 1002 Dutch internet survey panel members with diverse sociodemographic backgrounds. The instrument was developed in two stages: a preparation phase consisting of focus groups and expert consultations, and a validation among a representative panel of Dutch citizens. The goal of the preparation phase, was to pilot test and refine previously proposed Positive Health questionnaires into an initial version of the CPHQ. The validation phase aimed to examine the initial CPHQ’s factorial validity using Factor Analysis, and its concurrent validity using Multivariate Regression Analysis. The developed questionnaire demonstrated adequate factorial and concurrent validity. Furthermore, it explicitly includes an assessment of resilience, this being a key component of PH. The introduced measurement tool, the CPHQ, comprises 11 dimensions that we have labeled as follows: relaxation, autonomy, fitness, perceived environmental safety, exclusion, social support, financial resources, political representation, health literacy, resilience, and enjoyment. In this article, we present four major contributions. Firstly, we embedded the measurement in a theoretical framework. Secondly, we focused the questionnaire on a key concept of Positive Health - the “ability to adapt.” Thirdly, we addressed issues of health inequality by considering contextual factors. Finally, we facilitated the development of more understandable measurement items.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140562609","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}

{"title":"Health system implementation of the PROMIS Cognitive Function Screener in the Medicare Annual Wellness Visit: framing as abilities versus concerns","authors":"Jordan M. Harrison, Natalie C. Ernecoff, Jin-Shei Lai, Janel Hanmer, Rebecca Weir, Anthony Rodriguez, Michelle M. Langer, Maria O. Edelen","doi":"10.1186/s41687-024-00699-8","DOIUrl":"https://doi.org/10.1186/s41687-024-00699-8","url":null,"abstract":"Cognitive assessment is a required component of the Medicare Annual Wellness Visit (AWV). In this prospective study, we evaluated acceptability and usefulness of a patient-reported outcome measure (the PROMIS® Cognitive Function Screener, or PRO-CS) to screen for cognitive impairment during the AWV. We compared two versions of the PRO-CS: Abilities and Concerns. We developed PRO-CS Abilities and PRO-CS Concerns using items from the PROMIS Cognitive Function item banks. We partnered with a large health system in Pennsylvania to implement an electronic health record (EHR)-integrated version of the 4-item PRO-CS into their AWV workflow. PRO-CS Abilities was implemented in June 2022 and then replaced with PRO-CS Concerns in October 2022. We used EHR data to evaluate scores on Abilities versus Concerns and their association with patient characteristics. We gathered feedback from providers on experiences with the PRO-CS and conducted cognitive interviews with patients to evaluate their preferences for Abilities versus Concerns. Between June 2022 and January 2023, 3,088 patients completed PRO-CS Abilities and 2,614 patients completed PRO-CS Concerns. Mean T-scores for Abilities (54.8) were slightly higher (indicating better cognition) than for Concerns (52.6). 10% of scores on Abilities and 13% of scores on Concerns indicated concern for cognitive impairment (T-score < 45). Both Abilities and Concerns were associated with clinical characteristics as hypothesized, with lower scores for patients with cognitive impairment diagnoses and those requiring assistance with instrumental activities of daily living. Abilities and Concerns had similar negative correlations with depression (r= -0.31 versus r= -0.33) and anxiety (r= -0.28 for both), while Abilities had a slightly stronger positive correlation with self-rated health (r = 0.34 versus r = 0.28). In interviews, providers commented that the PRO-CS could be useful to facilitate conversations about cognition, though several providers noted potential limitations of patient self-report. Feedback from patients indicated a preference for PRO-CS Concerns. Our findings suggest potential utility of the PRO-CS for cognitive screening in the Medicare AWV. PRO-CS Abilities and Concerns had similar associations with patient clinical characteristics, but the Concerns version was more acceptable to patients.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140562594","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}

{"title":"Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items","authors":"Joel Sims, Brigitte Sloesen, Sarah Bentley, Christel Naujoks, Rob Arbuckle, Sima Chiva-Razavi, Ben Pascoe, Jan Stochl, Amy Findley, Paul O’Brien, James S. Wolffsohn","doi":"10.1186/s41687-024-00717-9","DOIUrl":"https://doi.org/10.1186/s41687-024-00717-9","url":null,"abstract":"The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0–42) was recommended, including a more specific responder definition of 10-point improvement. The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140562595","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}

{"title":"Exploring the effects of fitbit incentive on treatment outcomes in veterans undergoing intensive pain rehabilitation program","authors":"Tiffany Toor, Sarah Palyo, Kathryn Schopmeyer, Alan N. Simmons, Irina A. Strigo","doi":"10.1186/s41687-024-00721-z","DOIUrl":"https://doi.org/10.1186/s41687-024-00721-z","url":null,"abstract":"This study compares clinical pain outcomes between patients in a pain treatment program that received a Fitbit, to patients that did not. We also explored: (1) cognitive, emotional, and psychological factors that may have impacted the decision to opt in to receiving a Fitbit; and (2) whether the choice to receive a Fitbit impacted changes in cognitive, emotional, and psychological factors following treatment. Among 58 patients in a multidisciplinary pain treatment program at a Veterans Affairs Healthcare System hospital, 31 patients opted to receive a Fitbit as adjunct treatment, while 27 did not. This study utilized patient-reported and practitioner-collected data from the pain treatment program. Compared to the non-Fitbit group, the Fitbit group displayed a significant decrease in average pain intensity, however showed no correlation between Fitbit activity and average pain intensity. Additionally, treatment satisfaction was the only predictor of treatment group, when modeling pre- and post-treatment outcomes changes. The implementation of a Fitbit may lead to improved pain intensity. Initial evidence suggests that opting to receive a Fitbit during a pain treatment program indicates treatment engagement leading to greater treatment satisfaction. Future work is needed to verify and expand upon this potential mechanism.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140562440","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}

{"title":"Measuring refugees' capabilities: translation, adaptation, and valuation of the OxCAP-MH into Juba Arabic for use among South Sudanese male refugees in Uganda.","authors":"C F van der Boor, D Taban, K Ismail, J Simon, B Roberts, D Fuhr, W A Tol, G Greco","doi":"10.1186/s41687-024-00720-0","DOIUrl":"10.1186/s41687-024-00720-0","url":null,"abstract":"<p><strong>Background: </strong>Forcibly displaced populations are highly vulnerable to psychosocial distress and mental disorders, including alcohol misuse. In an ongoing trial that seeks to develop a transdiagnostic intervention addressing psychological distress and alcohol use disorders among conflict-affected populations, we will carry out a cost-effectiveness evaluation using a capability-based Oxford Capabilities Mental Health (OxCAP-MH) measure. The OxCAP-MH is a 16-item questionnaire developed from the Capability Approach, that covers multiple domains of functioning and welfare. The aim of the current paper is to present the results of the translation, cultural adaptation and valuation of the OxCAP-MH into Juba Arabic for South Sudanese refugees living in Uganda. We adhered to the official Translation and Linguistic Validation process of the OxCAP-MH. To carry out the translation, the Concept Elaboration document, official English version of the OxCAP-MH, and the Back-Translation Review Template were used. Four independent translators were used for forward and back translations. The reconciled translated version was then piloted in two focus group discussions (N = 16) in Rhino refugee settlement. A most important to least important valuation of the sixteen capability domains covered in the OxCAP-MH was also done.</p><p><strong>Results: </strong>The Juba Arabic version of the OxCAP-MH was finalized following a systematic iterative process. The content of the Juba Arabic version remained unchanged, but key concepts were adapted to ensure cultural acceptability, feasibility, and comprehension of the measure in the local context of Rhino refugee settlement. Most participants had low levels of literacy and required support with filling in the tool. Participants suggested an additional capability that is currently not reflected in the OxCAP-MH, namely access to food. Furthermore, discussions around the valuation exercise of the sixteen domains led to two separate importance scales, which showed relevant differences.</p><p><strong>Conclusions: </strong>In this context, the OxCAP-MH was considered culturally acceptable. The valuation exercise proved cognitively demanding. Participants voiced confusion over how to answer the questions on the OxCAP-MH instrument due to low levels of literacy. These concerns invite consideration for future research to consider how measures such as the OxCAP-MH can be made more accessible to individuals with low literacy rates in resource poor settings.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10987405/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140337093","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":"Construct validity of EQ-5D-5L among patients with inflammatory bowel disease-a study based on real-world data from the Swedish Inflammatory Bowel Disease Registry.","authors":"Jack Latteur, Olivia Ernstsson, Evalill Nilsson, Susanna Jäghult, Emelie Heintz","doi":"10.1186/s41687-024-00709-9","DOIUrl":"10.1186/s41687-024-00709-9","url":null,"abstract":"<p><strong>Objectives: </strong>The Swedish Inflammatory Bowel Disease Registry (SWIBREG) includes approximately 84% of all patients with inflammatory bowel disease (IBD) treated with immunomodulators, biologics or surgery in Sweden. Data on health-related quality of life (HRQoL) have been collected using EQ-5D-5L in the registry since 2012. Nevertheless, there are few studies assessing the validity of EQ-5D-5L in this patient population. Thus, the aim of this study was to assess the construct validity of EQ-5D-5L amongst patients with IBD (ulcerative colitis and Crohn's disease).</p><p><strong>Methods: </strong>Individual-level data on EQ-5D-5L and other disease-specific measures were extracted from SWIBREG. Known-groups validity was assessed by analysing whether the EQ-5D-5L captured expected differences between patient groups with different activity levels of the disease. Convergent validity was assessed by analysing whether the reported problems in the dimensions of EQ-5D-5L, EQ VAS, and the EQ-5D-5L index value correlated, as hypothesized, with the four dimensions in the Short Health Scale, a symptom index question, and the Physician Global Assessment (PGA) score.</p><p><strong>Results: </strong>In total, 9769 patients with IBD were included in the study. Patients with active IBD reported more health problems in the EQ-5D-5L descriptive system than patients being in remission. The effect sizes for the differences in reported problems between patients with active and inactive disease were at least small (≥0.1) or medium (≥0.3) in all dimensions except self-care. Differences in the mean EQ-5D-5L index and EQ-VAS score between patients with active and inactive disease were statistically significant (p < 0.001) and larger than pre-defined cut-offs for minimally important differences (>0.08 for the index and >11.0 for EQ-VAS). The analysis of convergent validity showed that EQ-5D-5L results correlated as expected with the disease-specific measures in 16 of the 21 analyses. In total, 22 (79%) of the 28 hypotheses were supported.</p><p><strong>Conclusion: </strong>The findings support the construct validity of EQ-5D-5L amongst patients with IBD and contribute to the scarce literature on the validity of the five-level version of EQ-5D in this patient population. These findings have important implications for the choice of HRQoL measure in routine health care registries like SWIBREG as well as for future clinical or health economic studies considering using EQ-5D-5L as a measure of HRQoL.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10973303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140307243","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}