Quality of Life Research最新文献

{"title":"Placebo response variability on health-related quality of life outcomes in irritable bowel syndrome: an arm-based network meta-analysis.","authors":"Zhenzhi Wang, Yukun Chen, Xinyu Li, Li Lin, Bozhu Chen, Min Chen, Hui Zheng","doi":"10.1007/s11136-025-03927-w","DOIUrl":"10.1007/s11136-025-03927-w","url":null,"abstract":"<p><strong>Objectives: </strong>The impact of placebo response on health outcomes in various diseases, including IBS, is significant. To better understand the effect of different placebo administration methods on the observed outcomes in IBS studies, this meta-analysis aims to explore research findings on the degree of improvement.</p><p><strong>Methods: </strong>The meta-analysis included 45 randomized, double-blind, placebo-controlled clinical trials involving 5174 patients with confirmed IBS (excluding those with significant comorbidities). The trials were designed to compare the efficacy of different placebo interventions. The primary outcome was the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), and secondary outcomes included the Irritable Bowel Syndrome Quality of Life Instrument (IBS-QoL) and the IBS Symptom Visual Analog Scale (VAS). An arm-based Bayesian network meta-analysis was performed to examine the relative effectiveness of the placebo interventions on the outcomes.</p><p><strong>Results: </strong>The analysis revealed that sham moxibustion exhibited the most significant efficacy in reducing IBS-SSS (MD -260.00, 95% CrIs: -288.00 to -232.00). Additionally, sham FMT resulted in significant improvements in IBS-QOL scores (MD 9.23, 95% CrIs - 3.69 to 22.30). Meanwhile, placebo tablet interventions were found to be the most effective in reducing VAS scores (MD 4.71, 95% CrIs, -1.14 to 11.10). Overall, this synthesis provides detailed insights into the effectiveness of placebos in addressing different outcome measures.</p><p><strong>Conclusions: </strong>Sham moxibustion appears to provide subjective benefits for patients' IBS symptoms. However, the evidence for its efficacy is less robust compared to other interventions, as assessed by GRADE. Understanding the placebo effect in IBS management is crucial for clinical practice and drug development, particularly in placebo comparisons.</p><p><strong>Registration id: </strong>INPLASY2024110111. https://doi.org/10.37766/inplasy2024.11.0111 .</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1553-1568"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations between financial toxicity, health-related quality of life, and well-being in Indonesian patients with breast cancer.","authors":"Stevanus Pangestu, Fredrick Dermawan Purba, Hari Setyowibowo, Clara Mukuria, Fanni Rencz","doi":"10.1007/s11136-025-03925-y","DOIUrl":"10.1007/s11136-025-03925-y","url":null,"abstract":"<p><strong>Objectives: </strong>Financial toxicity (FT) is the impairment of financial well-being experienced by patients with cancer, categorized into subjective (SFT) and objective (OFT) forms. This study aimed to investigate the associations between FT, health-related quality of life, and overall well-being in patients with breast cancer.</p><p><strong>Methods: </strong>We analyzed baseline data from a single-center longitudinal study in Indonesia. Patients completed the EQ-5D-5L, EQ Health and Wellbeing (EQ-HWB), COST: A FACIT Measure of Financial Toxicity (FACIT-COST, for measuring SFT), and OFT-related questions. Ordinal logistic regression was used to examine the associations between FT and selected EQ-5D-5L and EQ-HWB items. Multivariable linear regression was used to assess the associations of FT and EQ-5D-5L and EQ-HWB-S index values. The main regression models were adjusted for socio-demographic and clinical factors such as age, income, metastasis status, and symptoms.</p><p><strong>Results: </strong>The survey included 300 female patients with breast cancer undergoing treatment (mean age = 51). Overall, 21% experienced high SFT (FACIT-COST ≤ 17.5) and 51% reported any OFT (e.g., incurring debt). Adjusted for covariates, higher SFT was associated with more problems in EQ-5D-5L pain/discomfort and anxiety/depression, and in EQ-HWB exhaustion, anxiety, sadness/depression, frustration, pain, and discomfort. OFT was associated with more problems in exhaustion. Higher SFT was associated with lower EQ-5D-5L and EQ-HWB-S index values, with explained variances of 46.3% for EQ-HWB-S and 31.2% for EQ-5D-5L.</p><p><strong>Conclusions: </strong>This study is the first to explore the associations between financial toxicity, EQ-5D-5L, and EQ-HWB outcomes in breast cancer. Our findings provide insight into the cancer burden and its link to health and well-being.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1709-1722"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Valuing health-related quality of life: an EQ-5D-5L value set for Morocco.","authors":"Asmaa Azizi, Amal Boutib, Doha Achak, Fredrick Dermawan Purba, Fanni Rencz, Elmadani Saad, Abderraouf Hilali, Samir Ahid, Chakib Nejjari, Elly A Stolk, Bram Roudijk, Ibtissam Youlyouz-Marfak, Abdelghafour Marfak","doi":"10.1007/s11136-025-03930-1","DOIUrl":"10.1007/s11136-025-03930-1","url":null,"abstract":"<p><strong>Purpose: </strong>There is a growing interest in Health Technology Assessment (HTA) in Morocco. A national EQ-5D-5L value set would allow for the computation of Quality Adjusted Life Years (QALYs) in economic evaluations of healthcare interventions to support decision-making. This study aimed to develop a Moroccan EQ-5D-5L value set based on data from a representative sample of the Moroccan adult general population.</p><p><strong>Methods: </strong>A Moroccan representative sample of adults was recruited using stratified quota sampling based on gender, age category, and place of residence. Data were collected between November 2022 and December 2023 using the international EuroQol valuation protocol, EQ-VT version 2.6.1. This protocol includes two elicitation techniques: the composite time trade-off (cTTO) and the discrete choice experiment (DCE). cTTO and DCE data were modeled using a heteroskedastic Tobit model and a conditional logit model, respectively. In addition, these models were combined using a hybrid model.</p><p><strong>Results: </strong>A total of 976 respondents were included in the final analysis. The hybrid heteroskedastic model was considered the preferred model. The predicted utility values ranged from -1.492 for the worst health state (55555) to 1 for full health (11111), where the two mildest impaired states (11211 and 21111) had a utility value of 0.979. Pain/discomfort had the largest effect on health utility values, followed by anxiety/depression, mobility, self-care and usual activities.</p><p><strong>Conclusion: </strong>Morocco is the third country in the Middle East and North Africa (MENA) region with an EQ-5D-5L value set. This study supports the use of EQ-5D-5L data for healthcare decision-making in the Moroccan context.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1783-1796"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143524213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding the health-related quality of life impacts of caring for children and adolescents with rare progressive life-limiting conditions: key challenges and future research priorities.","authors":"Philip A Powell, Jill Carlton, Tessa Peasgood, Fleur Chandler, Josie Godfrey, Emily Reuben","doi":"10.1007/s11136-025-03937-8","DOIUrl":"10.1007/s11136-025-03937-8","url":null,"abstract":"<p><p>The inclusion of health-related quality of life (HRQoL) impacts on informal carers in health technology assessments (HTAs) is lacking due, primarily, to a deficiency in evidence and methodological issues on how informal carer HRQoL is captured and incorporated into economic models. These issues are magnified in areas of significant burden, such as caring for children and adolescents with rare, progressive, life-limiting conditions. In this commentary we outline key challenges in measuring, and incorporating in HTA submissions, informal carer HRQoL data in rare, progressive, paediatric, life-limiting conditions and identify future research priorities in this space. We argue that: (i) a generic model of carer HRQoL is likely inadequate to characterise the HRQoL impacts in this population; (ii) the underlying evidence-base is underdeveloped, including understanding commonalities across conditions, impact beyond the primary carer, and differences over time; and (iii) methodological challenges in modelling informal carer HRQoL in cost-effectiveness analysis are inhibiting progress. A research agenda is proposed that addresses these challenges by focusing first on in-depth qualitative research to develop an appropriate, content valid 'disease-group-specific' model for understanding informal carer HRQoL in rare, progressive, paediatric, life-limiting conditions. This model can be used to inform the appropriate measurement of carer HRQoL in this population, which, alongside methodological research on addressing modelling challenges, can help to facilitate the recommended inclusion of informal carer HRQoL data in HTA submissions for children and adolescents living with rare, progressive, life-limiting conditions.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1579-1585"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A systematic review of outcome measurement instruments used in pouch anal and vaginal fistulae: a COSMIN-based analysis.","authors":"Easan Anand, Shivani Joshi, Lillian Reza, Kapil Sahnan, Phillip Lung, Ailsa Hart, Phil Tozer","doi":"10.1007/s11136-025-03911-4","DOIUrl":"10.1007/s11136-025-03911-4","url":null,"abstract":"<p><strong>Purpose: </strong>Pouch-related fistulae are devastating complications of ileoanal pouch surgery, which is performed to improve the quality of life (QoL) for patients who have had a proctocolectomy. Their management is limited by inconsistent evidence, including using poorly and heterogeneously defined outcomes. This study aims to identify all Outcome Measurement Instruments (OMIs) used in pouch fistula research, including Patient-Reported Outcome Measures (PROMs) and Clinician-Reported Outcome Measures (ClinROMs) and evaluate their quality using COSMIN guidelines to help select the best tool for a standardised core outcome measurement set in a future consensus study.</p><p><strong>Methods: </strong>A systematic review was conducted to identify all OMIs used in ileo-anal pouch fistulae studies, from MEDLINE, Embase, and the Cochrane Library. We evaluated existing OMIs based on COSMIN guidelines and used the GRADE approach to assess evidence quality. Results were synthesized narratively.</p><p><strong>Results: </strong>Among 91 studies, 13 OMIs were reviewed. Pouch-specific instruments performed poorly in key domains of reliability, validity, and responsiveness. Only 17.6% of studies assessed QoL using PROMs. The best-performing instruments were the SF-36 and IBDQ. The Ileoanal Pouch Syndrome Severity Score was the only pouch-specific instrument that involved patients in its development and although useful for pouch dysfunction, it lacks specific QoL assessment and was not validated in pouch-fistulae patients.</p><p><strong>Conclusion: </strong>Existing OMIs for pouch-related fistulae lack adequate measurement properties, with no PROMs specifically validated for QoL in this population and very few instruments involving patients in their development. There is an unmet need for a validated PROM specifically for QoL in pouch-related fistulae.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1521-1539"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Family functioning and health-related quality of life in children and young adults with Marfan syndrome.","authors":"Lauren S Crafts, Lynn A Sleeper, Karen Uzark, Andrew M Atz, Timothy J Bradley, Elizabeth Cappella, Veronica Fettig, Georgeann Keh Teng Groh, Michelle S Hamstra, Christina Hartje-Dunn, Jami C Levine, Ian Lindsay, Aaron K Olson, Gretchen MacCarrick, Larry W Markham, Tonia Morrison, Reed E Pyeritz, Seda Tierney, Ronald V Lacro","doi":"10.1007/s11136-025-03944-9","DOIUrl":"10.1007/s11136-025-03944-9","url":null,"abstract":"<p><strong>Purpose: </strong>Evaluate family functioning (FF) and associations with quality of life (QOL) in a large, multicenter cohort of children and young adults with Marfan syndrome (MFS) who participated in the Pediatric Heart Network (PHN) Marfan Trial.</p><p><strong>Methods: </strong>Of the 608 patients enrolled in the PHN Marfan Trial, 359 families completed one or more of the following: the General Functioning subscale of the Family Assessment Device (FAD), the Condition Management Ability module of the Family Management Measure (FaMM), and the Pediatric Quality of Life Inventory (PedsQL) at the final trial visit at three years. The correlations between FAD and FaMM scores and patient-related factors were examined. Linear regression was used to determine the relationship between FAD, FaMM, patient-related factors, and PedsQL.</p><p><strong>Results: </strong>25% of families by self-report and 9% of families by parent-report had impaired functioning (FAD score > 2). FAD and FaMM were inversely correlated (R=-0.41, p < 0.001). Higher (worse) FAD scores were correlated with more patient-reported symptoms (R = 0.17, p = 0.003) and with lower QOL (R=-0.28, p < 0.001), independent of other factors typically related to QOL.</p><p><strong>Conclusions: </strong>In patients with MFS, family dysfunction and more symptoms were independently associated with worse QOL. This suggests that interventions addressing family dysfunction and symptoms may positively impact QOL for patients and families living with MFS.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1647-1655"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143658387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient experience of alpha-1 antitrypsin deficiency-associated liver disease: a qualitative study.","authors":"Virginia C Clark, Suna Park, Robert Krupnick, Nicole Sparling, Jason Ritchie, Chitra Karki, Justin A Reynolds","doi":"10.1007/s11136-025-03926-x","DOIUrl":"10.1007/s11136-025-03926-x","url":null,"abstract":"<p><strong>Purpose: </strong>To elicit the signs and/or symptoms, and impacts on daily living experienced by patients with alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD).</p><p><strong>Methods: </strong>A preliminary \"concept list\" of signs and/or symptoms, and impacts was developed from a targeted literature review, patient blog posts, and clinician interviews. Subsequently, one-to-one concept elicitation interviews involving English-speaking, US adults with AATD-LD and a protease inhibitor (Pi) ZZ or MZ genotype were conducted by trained interviewers following a central Institutional Review Board-approved discussion guide. An AATD-LD conceptual model was developed based on these findings. Concepts were \"most salient\" if reported by ≥ 8 patients with a mean bothersomeness/disturbance rating of ≥ 5, or \"highly salient\" if reported by > 5- < 8 patients with a mean bothersomeness/disturbance rating of ≥ 5 (scale: 0-10, 0: not at all bothersome/disturbing; 10: extremely bothersome/disturbing).</p><p><strong>Results: </strong>Fifteen patients were interviewed (median [range] age: 57 [28-78] years; Pi*ZZ, n = 12; Pi*MZ, n = 3). Of 41 signs and/or symptoms, the most salient were fatigue/tiredness, respiratory infections, shortness of breath, confusion/difficulty concentrating, and edema. Highly salient signs and/or symptoms were abdominal swelling, acid reflux, sleep disturbance, vomiting, abdominal pain/tenderness, itchiness, and back pain. Of 16 impacts, the most salient were on work and employment, leisure activities, and relationships. Impacts on mobility were highly salient.</p><p><strong>Conclusion: </strong>Several concepts were frequently reported as moderately/highly bothersome/disturbing. Further investigation of the experience of patients with AATD-LD in a large, diverse population across all fibrosis stages and genotypes is warranted. Clinical outcome assessments that capture salient concepts are needed.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1823-1832"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143625689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relationship between core symptoms, function, and quality of life in colorectal cancer patients: a network analysis.","authors":"Wenqian Qi, Ruzhen Zhou, Qun Qiu, Jing Cui","doi":"10.1007/s11136-025-03946-7","DOIUrl":"10.1007/s11136-025-03946-7","url":null,"abstract":"<p><strong>Purpose: </strong>To identify core symptoms in patients with colorectal cancer and investigate how these symptoms correlate with functional status and quality of life (QoL).</p><p><strong>Methods: </strong>This study included patients over 18 years of age who underwent therapeutic surgery for colorectal cancer with or without a stoma. The European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire Core 30 (EORTC-QLQ C30) and Colorectal Cancer Module (EORTC-QLQ CR29) were used. Data analysis involved constructing networks using the qgraph package in R, identifying core symptoms based on strength centrality, and assessing centrality stability using the bootnet package.</p><p><strong>Results: </strong>The study included 511 patients: 321 without a stoma and 190 with a stoma. The QoL score for both groups were 55.06 and 55.09, showing no significant difference (p= 0.991). Fatigue and pain are common core symptoms in colorectal cancer surgery patients, whereas appetite loss (r_s = 0.37) is specific to those without a stoma and body image concerns (r_s = 1.06) are central issues for stoma patients. Notably, despite its prevalence and severity, anxiety was not a core symptom in either group of patients. In the QoL network, emotional functioning served as an intermediary link between QoL and core symptoms in patients without a stoma, whereas QoL was directly associated with core symptoms in patients with a stoma.</p><p><strong>Conclusion: </strong>Improving quality of life requires distinct clinical pathways depending on whether the patient has a stoma, necessitating individualized symptom management strategies in the early postoperative period.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1723-1734"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Young children (6-7 years) can meaningfully participate in cognitive interviews assessing comprehensibility in health-related quality of life domains: a qualitative study.","authors":"Victoria Gale, Philip A Powell, Jill Carlton","doi":"10.1007/s11136-025-03940-z","DOIUrl":"10.1007/s11136-025-03940-z","url":null,"abstract":"<p><strong>Purpose: </strong>Establishing the comprehensibility of patient reported outcome measures (PROMs) in quality of life research is essential. Cognitive interviews are recommended as a 'gold standard' for evaluating comprehensibility among adult populations but are not routinely used with young children (≤ 7 years). The current study therefore aimed to evaluate the feasibility of cognitive interviewing using traditional and adapted methods with children aged 6-7 years to evaluate PROM item comprehensibility.</p><p><strong>Methods: </strong>Fourteen children (6-7 years) with a range of diagnosed health conditions participated in individual cognitive interviews. Each child answered six mock PROM items (physical, psychological, and social health-related quality of life domains) and concurrent verbal probes were used to evaluate item comprehensibility. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed using a novel Comprehensibility Continuum which coded the extent of alignment between children's explanations of items and intended meanings.</p><p><strong>Results: </strong>Cognitive interviews were successful; extent of comprehensibility could be determined for 83/84 (99%) item discussions. Most items were comprehensible, with children describing the intended item meaning for 74/84 (88%) items evidenced by contextual examples and/or de-contextual definitions in children's responses to verbal probes. Three items ('walk', 'sad', and 'made fun of') were identified as requiring further testing and/or refinement, where a lower percentage of discussions contained evidence of intended item meaning.</p><p><strong>Conclusion: </strong>Despite previous uncertainty, this study demonstrates how methodological challenges can be addressed to enable young children's participation in cognitive interviews evaluating item comprehensibility, ultimately contributing to the accurate measurement of young children's health outcomes in healthcare and research.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1633-1646"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determining minimal clinically important differences in ecological momentary assessment measures of fatigue in people with multiple sclerosis.","authors":"Sonia Sharma, Tiffany J Braley, Kevin N Alschuler, Dawn M Ehde, Anna L Kratz","doi":"10.1007/s11136-025-03948-5","DOIUrl":"10.1007/s11136-025-03948-5","url":null,"abstract":"<p><strong>Purpose: </strong>Fatigue is a common debilitating symptom of multiple sclerosis (MS). Ecological momentary assessment (EMA) provides a more reliable and sensitive assessment of fatigue outcomes relative to traditional recall surveys; however, the minimal clinically important difference (MCID) for EMA fatigue outcomes has not been established.</p><p><strong>Methods: </strong>MCIDs for EMA fatigue intensity and fatigue interference (0-10 numerical rating scale) that were assessed as outcomes in a pragmatic randomized clinical trial of three fatigue interventions were determined using two statistical approaches. The Patient Global Impression of Change (PGIC) and the Modified Fatigue Impact Scale (MFIS) were used within the anchor-based approach, and standard deviations (SD) and standard error of measurements (SEM) were examined within the distribution-based approach.</p><p><strong>Results: </strong>Pre- and post-treatment EMA data from 336 individuals with MS (76.2% female, 71.1% relapsing-remitting MS, mean age 48.8 (± 11.7) years, mean duration of MS 12.2 (± 9.8) years) were included in the analysis. Percent complete EMA data (4 EMAs/day) for 7 days were comparable pre- and post-treatment for fatigue intensity and for fatigue interference. Using the PGIC and MFIS anchors, change in EMA scores averaged 0.94 and 1.04 for fatigue intensity and 0.62 and 1.04 for fatigue interference, respectively. The SD and SEM for EMA fatigue intensity were 0.75 and 1.19 and for EMA fatigue interference were 0.83 and 1.30, respectively.</p><p><strong>Conclusion: </strong>Combining two approaches, our study contributes foundational information regarding meaningful change on EMA measures of fatigue, enabling effective use of EMA to assess fatigue treatment outcomes in a person-centered manner.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":"1749-1760"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143693123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}