Quality of Life Research最新文献

Introduction: Multiple sclerosis (MS) results in physical and cognitive impairments that negatively affect health-related quality of life (HRQoL). It is unknown to what extent the impact of MS-related impairments on HRQoL are reflected in the association of Expanded Disability Status Scale (EDSS) Functional Systems (FS) scores and EQ-5D-5L index values.

Methods: This cross-sectional, single-center cohort study recruited people with MS (pwMS) attending an outpatient clinic at a German university hospital. Impairment was assessed via FS scores during routine visits. HRQoL was measured with EQ-5D-5L index values. The association of each FS score with EQ-5D-5L index values and the additive effect of all FS on EQ-5D-5L index values was modeled with multivariate linear regression (MLR).

Results: Analyzing 115 participants, unadjusted MLR of single FS revealed that brainstem, pyramidal, cerebellar, sensory, and cerebral/cognitive dysfunctions were significantly associated with lower HRQoL. In MLR of all FS adjusted for covariates, a one standard deviation decrease in cognitive function was significantly associated with a 6% reduction in HRQoL.

Conclusion: Dysfunctions in FS contribute to a decrease in HRQoL. Cognitive dysfunction was identified to maintain negative association with HRQoL after adjustment for covariates, and routinely assessed FS scores appeared useful indicators to identify pwMS who may benefit from comprehensive cognitive evaluations. This study adds to the growing body of evidence emphasizing the crucial role of cognitive function in HRQoL of pwMS and highlights the need for effective screening and therapeutic strategies.

Purpose: To develop item banks and static short-forms for a patient reported outcome measure of perceived physical, mental, and emotional fatigability-the Michigan Fatigability Index (MIFI).

Methods: Building on earlier qualitative work, this study utilized cognitive interviews in samples representing the general adult population across the lifespan, people with multiple sclerosis (MS), or people with fibromyalgia (FM) to develop initial item pools. A nationwide cross-sectional survey study in MS and FM samples was used to field test items to develop item banks.

Results: Exploratory and confirmatory factors analyses indicated single underlying dimensions for each of the MIFI subdomains, and a graded response model (GRM) supported item fit of 42, 28, and 23 items to the physical, mental, and emotional fatigability items banks, respectively. Differential item functioning was not detected for age, condition (FM vs. MS), education level, ethnicity, race, or sex. Expert review and GRM calibration data was used to inform the selection of three 6-item short forms that assess physical, mental, and emotional fatigability and to program associated computer adaptive tests.

Conclusion: The MIFI shows initial evidence of good psychometric properties. Users can administer the MIFI as a static short form and efforts are underway to provide access to the measure as a computer adaptive test. T-Score scale conversion allows comparison of individual scores to a normative clinical sample with a wide range of fatigability.

Purpose: To characterize the relationship between ethnoracial identity, health-related social needs (HRSNs), and mental health (MH), and to examine the mediating role of HRSNs on the relationship between MH and ethnoracial identity.

Methods: Data from 30,437 adults who were seeking care within Mass General Brigham integrated health system in United States and had completed PROMIS Global Health within three years of their most recent HRSNs screening between March 1, 2018 and January 31, 2023 were included. The presence and magnitude of PROMIS Global MH score differences for six ethnoracial groups (White non-Hispanic, White Hispanic, Black (Hispanic and non-Hispanic), Asian non-Hispanic, Other non-Hispanic and Other Hispanic (includes Asian Hispanic) was assessed. Regression-based mediation analyses were used to examine mediating role of four HRSNs (food insecurity, housing instability, transportation barriers and inability to pay for housing utilities) on relationship between ethnoracial identity and MH.

Results: Compared to White Non-Hispanic patients, ethnoracial minorities had worse MH, after adjusting for age, sex, education, employment, marital status, comorbidities, and insurance type. This relationship remained statistically significant (p < 0.001) for White Hispanic, Asian non-Hispanic and Other non-Hispanic patients, where HRSNs mediated 57%, 88% and 70% of the relationship between ethnoracial identity and MH respectively. For Blacks and Other Hispanic patients, HRSNs fully mediated this relationship.

Conclusion: Disparities in MH may be driven by structural racism and experiences of racism that result in differentials in HRSNs, rather than ethnoracial identity. Efforts directed at measuring and addressing the HRSNs, in addition to structural factors are critical to achieving MH equity.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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.

Purpose: Identifying the underlying factors that contribute to poor wellbeing and developing strategies for early intervention are essential for promoting overall wellbeing. Many important aspects of wellbeing and quality of life are subjective experiences and therefore require self-report. The KIDSCREEN-27 questionnaire is widely used for this purpose. However, the self-report versions have mainly been validated for children aged 12 to 18 years. This study aims to develop a video-assisted format the KIDSCREEN-27 that enable self-report of wellbeing by children aged six to ten years and to test its psychometric properties.

Methods: The Danish-translated version KIDSCREEN-27 was slightly adapted in wording and items (N=12) and a video-format, including audio, illustrations, and smiley-supported scales, was developed, and tested. Next, a psychometric investigation of this version (KIDSCREEN-VIDEO) was conducted on 788 Danish children aged six to ten years (49.8% girls).

Results: Confirmatory factor analysis showed an acceptable to good model-fit: X² = 727.053; df = 242; P <0.001; root mean squared error of approximation=0.05; the comparative fit index = 0.98; and the Tucker-Lewis index = 0.98, and factor loadings ranged from 0.40 to 0.88. Cronbach's alpha values ranged from 0.65 to 0.89, suggesting acceptable to good internal reliability of the scales. Linear mixed model analyses, and Pearson's r correlation coefficients showed positive associations with the global and physical self-worth scales, indicating convergent validity. The test for measurement invariance indicated the model fit for the five-factor model was consistent across sex and age groups.

Conclusion: Based on our results, the KIDSCREEN-VIDEO provides a promising self-reported measure for wellbeing among children aged six to ten.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Purpose: To test the feasibility of a co-designed PROMs collection system for hospitalised older adults.

Methods: A mixed-methods feasibility study was conducted sequentially across one acute and one sub-acute ward, over a 12-week period. Patients aged ≥ 60 years who discharged from hospital were eligible. The EQ-5D-5L with added items on fatigue and cognition was administered on discharge and at 3-6 months post-discharge. Administration was by either a research assistant or volunteer using a variety of modes (tablet computer, phone, SMS). Feasibility was evaluated using a feasibility framework to capture demand, implementation, practicality, and acceptability. Descriptive statistics were applied. Interviews were conducted with volunteers and analysed using deductive content analysis.

Results: Completion rates indicated high demand (discharge = 84%, n = 110/131; follow-up = 81%, n = 90/110). At discharge, most completed PROMs on the tablet (57%) and 9% were administered by a volunteer. Most required assistance using the tablet (67%) and the average time to administer PROMs was longest for the tablet (17.9 min, SD = 3.3), followed by phone (8.8 min, SD = 4.4) and SMS (1.3 min, SD = 0.5). Fewer participants reported acceptability with using the tablet (61%) compared to SMS (100%). At follow-up, most completed PROMs on the phone (82%) and the average time to administer PROMs was less than discharge (4.9 vs. 13.4 min). Volunteers reported administering PROMs to unwell patients was challenging.

Conclusion: A co-designed PROMs collection system demonstrated feasibility in hospitalised older adults with phone and SMS having greatest acceptability. Administration of PROMs by volunteers was not feasible.

Trial registration: ACTRN12623000576628. Registered 25 May 2023.

Few health-related constructs or measures have received a critical evaluation in terms of measurement equivalence, such as self-reported health survey data. Differential item functioning (DIF) analysis is crucial for evaluating measurement equivalence in self-reported health surveys, which are often hierarchical in structure. Traditional single-level DIF methods in this case fall short, making multilevel models a better alternative. We highlight the benefits of multilevel modeling for DIF analysis, when applying a health survey data set to multilevel binary logistic regression (for analyzing binary response data) and multilevel multinominal logistic regression (for analyzing polytomous response data), and comparing them with their single-level counterparts. Our findings show that multilevel models fit better and explain more variance than single-level models. This article is expected to raise awareness of multilevel modeling and help healthcare researchers and practitioners understand the use of multilevel modeling for DIF analysis.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.