Quality of Life Research最新文献

Patient reported outcome measures (PROMs) now play a significant role in randomized control trials (RCTs) providing the basis for efficacy or safety endpoints. Most PROM data is quantitative and is summarized at the group level. Whilst PROM data is informative in providing the aggregated patient perspective on disease and interventions, it provides little information about the patients' individual experiences. For this, qualitative 'case study' research is needed. However, qualitative case-study research has traditionally not been considered as robust for establishing causal inference due to its singular nature and lack of quantifiable findings. The focus of this paper was to advance a proposal as to how to produce a single mixed-methods case analysis of an individual's experiences with treatment from PROM and narrative data that can be used in causal inference research; so-called "Causal singularism".

Purpose: This study aimed to identify trajectories of BMI, obesity-specific health-related quality of life (HR-QoL), and depression trajectories from pre-surgery to 24 months post-bariatric metabolic surgery (BMS), and explore their associations, addressing subgroup differences often hidden in group-level analyses.

Method: Patients with severe obesity (n = 529) reported their HR-QoL and depression before undergoing BMS, and at 12 and 24 months post-operation. Latent Class Growth Analysis was used to identify trajectories of BMI, HR-QoL and depression.

Results: BMI and HR-QoL improved significantly for all patients from pre-surgery to 24 months post-operation, though some patients deteriorated in their outcomes after 12 months. Three distinct trajectories of BMI were identified: Low (35.4%), Medium (45.5%), and High (19.2%), and of HR-QoL: High (38.4%), Medium (43.4%), and Poor (18.1%). Three trajectories of depression were extracted: Low/none (32.4%), Medium-low (45.3%), and Worsening (22.3%). The association between the trajectories of BMI and depression was significant, but not between the BMI and HR-QoL trajectories. Specifically, the Low BMI trajectory patients were more likely to follow the Worsening depression trajectory and reported poorer preoperative psychological health than the other two BMI trajectories.

Conclusion: Patients following the most favourable weight loss trajectory may not manifest psychologically favourable outcomes (i.e., Worsening depression), and preoperative characteristics do not consistently describe post-surgical BMI trajectories. Clinicians should tend to patients' mental wellbeing besides weight loss post-BMS. The study findings emphasize the significance of incorporating psychological health as an essential component of surgical outcomes.

Purpose: Health literacy is a key aspect of healthy living and is widely recognized as a crucial determinant of health outcomes and disparities. Health literacy enables individuals to make informed decisions by accessing, understanding, and utilizing health-related information effectively. Access to and use of health information are essential for optimal health outcomes. This study explores whether different health information sources, such as active, interpersonal, and passive sources, moderate the relationship between health literacy and health-related quality of life (HRQoL).

Methods: This study analyzed data from the 2021 Korea Health Panel (Version 2.1) including 4164 eligible samples. Health literacy was assessed using the Korean version of the European Health Literacy Survey Questionnaire. Complex sample analysis was used to compute descriptive statistics of the study variables. To determine the moderating effects of health information sources, this study used Hayes's PROCESS macro (Model 1).

Results: Among the weighted sample of 16,351,227 participants, 76.1% used active sources to obtain health information, whereas 13.5% and 10.5%, respectively, used interpersonal and passive sources. Regression analysis showed that the moderating effects of health information sources were positively significant. The associations between health literacy and HRQoL were stronger in the interpersonal source group compared to the active or passive source groups.

Conclusion: This study highlights the moderating role of interpersonal health information sources in enhancing the relationship between health literacy and health-related quality of life. Interventions targeting interpersonal communication channels may be effective in improving health outcomes, particularly among populations with limited health literacy.

Purpose: Sleep (SL), physical activity (PA), and wellbeing (WB) are three factors linked to positive development in adolescence. Despite theoretical support and some empirical evidence of developmental associations between these factors, few studies have rigorously investigated reciprocal associations over time separating between-person and within-person effects, and none have investigated all three in concert. Thus, it remains unclear how the interplay between SL, PA and WB unfolds across time within individuals. This study examines this question in the crucial early-to-mid-adolescence developmental transition.

Method: Separating between- and within-person effects, a random-intercept cross-lagged panel model was fitted to a dataset of N = 27,949 adolescents (age 12/13 at first timepoint) from Greater Manchester, England, using a three-by-three design (three annual timepoints: T1, T2, T3; three variables: SL, PA, WB).

Results: Analyses revealed gender-specific developmental cascade pathways. Specifically, we found positive reciprocal associations between SL and WB for girls (at T1→T2), whereas for boys, SL positively predicted WB (at both T1→T2 and T2→Τ3) but WB did not predict SL. We also found that WB predicted PA for boys (at T2→T3) but this finding was sensitive to model specification and yielded a smaller effect than other cross-lagged pathways.

Conclusion: Our results highlight the importance of sleep as a driver of adolescent wellbeing, and the role of gender in developmental cascade processes. Study strengths, limitations, and implications are discussed.

Purpose: To assess the relationship between quality of life (QoL) and ocular surface health within a Finnish population-based cohort.

Methods: A cross-sectional study involved 601 individuals born between the years 1933-1956. Ocular surface health and dry eye disease (DED) were clinically evaluated using several diagnostic tests. Participants completed the Ocular Surface Disease Index (OSDI), QoL assessment with the 15D and Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), and the Beck's Depression Inventory (BDI-II) questionnaires. Various statistical methods were employed to explore the associations between QoL, ocular surface health, and sex disparities.

Results: DED had negative impact on QoL in all participants, and especially in women. Adjusted for comorbidities, DED doubled the odds of worse health-related QoL (15D: OR = 2.31 [95% CI: 1.24-4.31, p < 0.01]) and mental health (SF-36 MCS and BDI-II: OR = 2.08 [95% CI: 1.04-4.16, p < 0.05]). Noninvasive tear break-up time (NIBUT) correlated with all QoL scores. In women, the most significant clinical signs correlating with low QoL were NIBUT (15D: r = 0.20, p = 0.002; SF-36 MCS: r = 0.18, p = 0.026), and conjunctival staining (15D: r=-0.19, p = 0.004; BDI-II: r = 0.27, p < 0.001), whereas in men, blepharitis correlated with depression score (BDI-II: r = 0.20, p = 0.036). High OSDI was associated with worse QoL in women, but not in men.

Conclusion: This first population-based study assessing general QoL data with objective clinical measures of DED indicated that among elderly population, both symptoms and signs of DED independently impacted different aspects of QoL. In addition, significant sex-differences in these associations were observed and should be considered both in research settings and when assessing and treating people with DED.

Purpose: Involving patients in developing patient-reported outcome measures (PROMs) is essential for accurately capturing their perspectives. However, understanding how patients were involved in developing PROMs used after hip or knee arthroplasty is limited. This scoping review aimed to evaluate whether patients were involved in the development of these PROMs and how they were involved.

Methods: Two independent reviewers documented patient involvement in item development and comprehensibility testing for 50 PROMs used after hip or knee arthroplasty. Trends in patient involvement over time were analyzed using binary logistic regression.

Results: There was no documentation of patient involvement in a collaborative role during the PROM development processes. Regarding the consultative role, of these 26 PROMs, they contributed to item development in 13 PROMs (26%) and comprehensibility testing in four PROMs (8%) and both item development and comprehensibility testing in nine PROMs (18%). Patients who underwent arthroplasty were involved in one or both phases in ten PROMs (20%), while patients with other lower extremity conditions were involved in 16 PROMs (32%). Patients who underwent arthroplasty contributed to both phases in five PROMs: Oxford Knee Score-Activity and Participation Questionnaire, Patient's Knee Implant Performance Questionnaire, Patient-Reported Outcomes Measurement Information System R-Plus-Osteoarthritis of the Knee, Oxford Arthroplasty Early Recovery Score and Oxford Arthroplasty Early Change Score. In addition, our analysis revealed no significant change in patient involvement in a consultative role during either item development or comprehensibility evaluation over time since 1982, when the first PROM included in this review was developed (p = 0.21).

Conclusions: Almost half of PROMs used after arthroplasty did not involve patients in their development, highlighting the need to address this gap in development of PROMs. There is also a need to analyze PROMs to ensure they accurately reflect the outcomes that matter to patients.

Purpose: Outcome-based pricing models which consider domains of value not previously considered in healthcare, such as societal outcomes, are of increasing interest for healthcare systems. Societal outcomes can include family-reported outcome measures (FROMs), which measure the impact of disease upon the patient's family members. The FROM-16 is a generic and easy-to-use family quality of life tool, but it has never been used in the context of patients undergoing advanced therapy medicinal product (ATMP) treatment. The use of potentially curative ATMPs is limited due their high cost and the low number of eligible patients. Using the FROM-16 to collect the impact on family of disease and treatment in ATMP patients may demonstrate additional value created by an ATMP intervention and strengthen the case for its use.

Methods: This feasibility study aimed to test the validity of the FROM-16 in family members of ATMP patients as a prelude for its use in ATMP value estimation. Patients and family members (n = 24) were recruited from ATMP treatment centres in England and Wales. Family members completed the FROM-16 and were invited to a short debriefing interview.

Results: The FROM-16 showed high validity demonstrated by strong internal consistency (Cronbach's alpha = 0.917) and intraclass correlation (0.803, 95%). Interviews identified that whilst the FROM-16 covered most areas of quality-of-life impact experienced by the participants, some explained that they also experienced other impacts upon their personal health and future outlook.

Conclusion: This feasibility study provides evidence that the FROM-16 could be used as part of a structured systematic approach to measure family quality of life impact in ATMP patients.

Purpose: Meaningful change thresholds are important to help interpret patient-reported outcome scores. To date, meaningful within-patient change (MWPC) thresholds have only been proposed for NSCLC-SAQ total score. This study proposed clinically MWPC thresholds, and group-level minimal important change/difference (MIC/MID) thresholds for both improvement and worsening for the Non-Small Cell Lung Cancer- Symptom Assessment Questionnaire (NSCLC-SAQ) total and symptom scores.

Methods: Blinded patient data (N = 246) from the Phase 3 LIBRETTO-431 clinical trial were used in a pre-specified meaningful change analysis. A combination of anchor- and supportive distribution-based methods were used to estimate the MWPC, MIC, and MID thresholds. Triangulation across anchor estimates was then performed using a correlation-weighted average to provide a single MWPC, MIC, and MID estimate for improvement and worsening.

Results: NSCLC-SAQ total score and symptom scores showed moderate to high correlations with various anchors (ranging from 0.306 to 0.890), with threshold estimates being provided from multiple anchors (except for cough). Triangulation suggested MWPC, MIC, and MID thresholds for improved total score were - 2.5, -3.5, and - 2.0, respectively. For worsening, the proposed thresholds were 2.0, 0.5, and 2.0, respectively. The MWPC, MIC, and MID thresholds for improved symptom scores ranged from - 0.5 to -1.5, and the worsening thresholds for symptom scores ranged from 0.5 to 1.0.

Conclusion: This study provides the first worsening and improvement estimates of MWPC, MIC, and MID for NSCLC-SAQ total and symptom scores. The thresholds proposed in this study can be used to inform interpretation of NSCLC-SAQ scores in clinical trials.

Purpose: To systematically review qualitative studies on outcomes, needs, experiences, preferences, concerns and health-related quality of life (HRQoL) of people surviving cancer in Europe in the last decade.

Methods: Protocol registered ( https://www.crd.york.ac.uk/PROSPERO , ID575065).

Inclusion criteria: studies with qualitative methods, constructs related to HRQoL, and adults surviving cancer in Europe. The search was conducted in PubMed and Scopus since 2013. Abstracts and full text were revised, data extracted and study risk of bias assessed independently by two researchers. The primary outcomes were the themes arising from each study. A thematic analysis stratified according to the study objective was undertaken by grouping themes into categories.

Results: Of 18,256 articles identified, 43 fulfilled the inclusion criteria: 16 studies with a generic objective and 27 with specific objectives. Seven categories (57 themes) emerged from the studies with a generic focus: Clinical Management (n = 16), Symptoms and Physical Function (n = 5), Psychological Function (n = 21), Social Function (n = 18), HRQoL (n = 3), Life Disruption (n = 6), and Individual Factors (n = 1). The 12 studies focused on treatment and care experiences stand out among those with specific objectives, with most themes fitting into the same seven categories.

Conclusions: Results clearly showed the predominance of the social and psychological function domains over physical domains among people surviving cancer, additionally identifying specific needs in clinical management, such as information and communication, and relationship with and support from professionals. Therefore, these aspects should be incorporated into the evaluation of patient-centred initiatives for people surviving cancer.

Limitations: only two databases were searched, and most European countries were not represented.

Purpose: MMQ1 is a Danish-language patient-reported outcome measure (PROM) for quality of life (QOL) in people with multiple long-term conditions (MLTC). It measures needs-based QOL across six scales: Physical ability, Concerns and worries, Limitations in daily life, Social life, Personal finances and Self-image. There is currently no such measure available in English. This study aimed to translate and validate MMQ1 for use in the United Kingdom.

Methods: Translation used a two-panel method (expert panel: n = 5; and lay panel: n = 6). Content validity was assessed via cognitive interviews (n = 6). A postal survey of 2,753 patients with MLTC recruited through eight GP practices in Scotland included EQ-5D-5L and ICE-CAP as comparator measures alongside MMQ1. Classical test theory psychometric analysis of survey responses followed the International Society for Quality of Life Research minimum reporting standards.

Results: Translation resulted in an English-language MMQ1 with good face validity. Cognitive interviews established good content validity. 597 survey responses were received (response rate 22%). Good internal consistency reliability and concurrent validity were demonstrated. Confirmatory factor analysis showed acceptable fit to the six-scales of MMQ1. Five of the six scales also demonstrated good discriminative ability for detecting clinically meaningful differences in QOL. However, inter-item and inter-scale correlations suggested item redundancy and scale overlap.

Conclusion: The English-language MMQ1 demonstrated adequate psychometric properties using classical test theory. Further validation using Rasch analysis is planned, and may help optimise and abbreviate the measure. This PROM has the potential to improve the measurement of QOL in MLTC research, including trials.