Health and Quality of Life Outcomes最新文献

Background: To assess fatigue in cancer patients, several patient-reported outcome measures (PROMs) are available that differ in content. To support the selection of suitable measures for specific applications and to evaluate possibilities of quantitative linking, the present study provides a content comparison of common fatigue measures, scales, and item banks. We included the EORTC CAT Core, EORTC QLQ-FA12, EORTC QLQ-C30, FACIT-F, PROMIS Fatigue (Cancer item bank v1.0), Brief Fatigue Inventory (BFI), Multidimensional Fatigue Inventory (MFI-20), Piper Fatigue Scale (PFS-12), and PRO-CTCAE.

Methods: All items of the included measures were linked to the International Classification of Functioning, Disability and Health (ICF). Additionally, they were categorized as assessing general, physical, emotional, or cognitive fatigue. Descriptive statistics were used to display the contents covered in each measure and to allow for a qualitative comparison.

Results: The measures consist of 160 items in total and covered primarily contents of the ICF components 'Body functions', 'Activities and participation', and 'Environmental Factors'. Most ICF codings refer to 'b1300 Energy level' (9-67% of the codings per instrument; 47% of all coded content). Within the broad categorization of types of fatigue, most items were classified as general fatigue (33-100% of the codings per instrument; 49% of the overall item pool). While the EORTC CAT Core focuses exclusively on physical and general fatigue, FACIT and BFI additionally assess emotional fatigue. The EORTC QLQ-FA12, PROMIS, MFI-20, and PFS-12 cover all fatigue components, including cognitive fatigue.

Discussion: The review provides an in-depth content comparison of PROMs assessing cancer-related fatigue. This can inform the selection of suitable measures in different clinical contexts. Furthermore, it will inform quantitative analyses to facilitate comparison of scores obtained with different PROMs.

Background: The use of EQ-5D instruments in clinical, policy and economic applications continues to grow internationally. Population norms studies provide baseline values against which demographic and patient groups are compared and inequality is assessed. This study presents updated EQ-5D-5L population norms for 2022-2023, evaluates inequality and compares the results with those of 2012.

Methods: Demographic and EQ-5D-5L data were obtained from mutually exclusive, representative samples of adults in three studies conducted from July 2022 through May 2023. EQ-5D-5L index values, EQ VAS scores, and ceilings (all dimensions at level 1) were calculated for age-sex groups and stratifiers including education, income, ethnicity, marital status, and employment status. For inequality, the Kakwani index was calculated for the EQ VAS scores and index values, and ordered logit models were used to obtain odds ratios for reporting higher levels of problems on each dimension for demographic groups. The results were compared with those from 2012 which included applying the value set that had been used for the 2022-2023 population norms to the 2012 states.

Results: Data were obtained form 2,989 respondents. The mean index value was 0.921, EQ VAS was 79.6 and the ceiling was 31.5%. The dimensions with the highest rates of reported problems at any level (2-5) were pain/discomfort (43%) and anxiety/depression (39%). The Kakwani index was 0.113 for EQ VAS and 0.058 for index values, with sex accounting for the largest relative contribution. Mean index values, EQ VAS scores, and ceilings were lower across all demographic groups in 2022-2023 compared to 2012.

Conclusions: This is the first study to investigate how EQ-5D-5L population norms have changed within a country over time. Significant changes were observed in the EQ-5D-5L measures and the relative frequencies of reported problems on the dimensions. Inequality increased, and there were changes in the levels of reported problems on the dimensions for demographic groups. Such changes suggest that national population norms should be updated periodically to capture changes in health status, perceptions of health, and health inequality.

Objective: This study aims to establish EQ-5D-Y-3L population norms in Jiangsu, China by conducting a large-scale cross-sectional survey.

Methods: Children and adolescents aged 9-17 from three cities of Jiangsu Province were selected by multistage stratified random sampling to complete the EQ-5D-Y-3L instrument independently. Population norms for Jiangsu, China were determined by calculating statistics based on age and gender. Logistic and Tobit regression models were employed to explain the relationship between HRQoL and factors such as sociodemographic characteristics/recent acute symptoms (experienced fever/cough/sore throat/diarrhea in the past two weeks).

Results: Three cities yielded 37,574 valid samples (a sample validity rate of 95.4%). The EQ-5D-Y-3L utility values (mean ± SD) were 0.964 ± 0.085 for males and 0.958 ± 0.077 for females. Males scored 85.94 ± 19.62 and females scored 84.83 ± 18.45 on the VAS (mean ± SD), while the percentages of respondents reporting full health ranged from 58.3 to 78.8%. The dimension in which most respondents reported having no problems was "feeling worried, sad, or unhappy" (23.0%). And the lowest HRQoL was shown in the 14-year-old age group. Gender, age, board at school, and BMI were found to have an association with HRQoL. In addition, recent acute symptoms also correlate with some aspects of HRQoL.

Conclusions: This study established EQ-5D-Y-3L population norms in Jiangsu, China for the first time. These norms will support resource allocation decision-making and be used as a reference for health evaluation studies.

Background: Patient-reported outcome measures (PROMs) provide invaluable information on patients' health outcomes and can be used to improve patient-related outcomes at the individual, organizational and policy levels. This systematic review aimed to a) identify contemporary applications and synthesize all evidence on the use of PROMs in these contexts and b) to determine characteristics of interventions associated with increased effectiveness.

Methods: Five databases were searched for studies providing quantitative evidence of the impact of PROM interventions. Any study design was permitted. An overall benefit (worsening) in outcome was defined as a statistically significant improvement (deterioration) in either a PROM, patient-reported experience measure or clinical outcome. Study quality was assessed using the Effective Public Healthcare Panacea Project's Quality Assessment Tool for Quantitative Studies. A narrative synthesis was conducted.

Results: Seventy-six studies of the 11,121 articles identified met the inclusion criteria. At the individual level, 10 (43%) of 23 studies that fed back PROMs to the patient or healthcare provider showed an improvement in outcome. This percentage increased in studies which used PROMs to monitor disease symptoms and linked these to care-pathways: 17 (68%) of 25 studies using this mechanism showed an improvement. Ten (71%) of 14 studies using PROMs to screen for disease found a benefit. The monitoring and screening approach was most effective using PROMs covering cancer-related, depression and gastro-intestinal symptoms. Three studies found that the mere collection of PROMs resulted in improved outcomes. Another three studies used PROMs in decision aids and found improved decision quality. At the organizational/policy level, none of the 4 studies that used PROMs for benchmarking found a benefit. The three studies that used PROMs for in-depth performance analyses and 1 study in a plan-do-study-act (PDCA) cycle found an improvement in outcome. Studies employing disease-specific PROMs tended to observe improved outcomes more often. There are concerns regarding the validity of findings, as studies varied from weak to moderate quality.

Conclusions: The use of PROMs at the individual level has matured considerably. Monitoring/screening applications seem promising particularly for diseases for which treatment algorithms rely on the experienced symptom burden by patients. Organizational/policy-level application is in its infancy, and performance evaluation via in-depth analyses and PDCA-cycles may be useful. The findings of this review may aid stakeholders in the development and implementation of PROM-interventions which truly impact patient outcomes.

Purpose: This study aims to investigate the potential impact of positive mental well-being on responses of patient-reported outcome measures (PROMs), such as EQ-5D-5L.

Methods: This study utilized the data collected in a cross-sectional study in a sample consisted of individuals with different health conditions. Spearman's rank correlations were employed to investigate the relationship between the responses to the dimensions of EQ-5D-5L and the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). A binary logistic regression analysis and ordered logistic multivariable regression were utilized to examine how SWEMWBS scores could impact the responses to EQ-5D-5L dimensions, while controlling for variables such as age, gender, education level, health conditions, caring experience, and data collection methods. The effects of SWEMWBS on EQ-VAS and utility values were also examined.

Results: One thousand nine individuals participated in the survey. Spearman's rank correlation revealed that all dimensions of EQ-5D-5L, except for the anxiety/depression dimension, exhibited weak correlations with all dimensions of SWEMWBS. Binary logistic regression and ordered logistic multivariable regression indicated that age, SWEMWBS scores, gender, health conditions, data collection methods, and caring experience significantly influenced the likelihood of reporting problems in EQ-5D-5L responses. Notably, better SWEMWBS outcomes increased the likelihood of reporting no or fewer problems across all EQ-5D-5L dimensions. Spearman's rank correlation suggested a moderate or strong positive correlation between SWEMWBS scores and EQ-5D-5L utility values and EQ-VAS. The results of multiple linear regression analysis revealed that SWEMWBS scores, health conditions, caring experience, and data collection methods were significantly associated with EQ-5D utility values and EQ-VAS.

Conclusions: Individuals with better positive mental well-being results are more likely to report better results in PROMs like EQ-5D-5L. Future study is needed to understand the thought process and to explore strategies to cope with the response heterogeneity that led by the status of mental well-being.

Objective: Ginkgo diterpene lactone meglumine (GDLM) could improve the functional outcome after acute ischemic stroke (AIS). This study aimed to investigate the efficacy of GDLM on the quality of life in patients with AIS in China.

Methods: This is a post hoc analysis of Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke trial. The quality of life was measured using the EuroQoL questionnaire, including EQ-5D and EQ visual analogue scale (EQ-VAS). The primary outcomes were changes in EQ-5D and EQ-VAS from baseline to day 14 and day 90 after randomization.

Results: A total of 3219 patients with completed data on outcomes were enrolled, with median age of 63 years (interquartile range, 55-70) and 2,067 (64.2%) men. GDLM was associated with a significant decrease in scores of ED-5Q components (from 0 [no problem] to 3[extreme problem]), the mean difference between GDLM and placebo group was -0.14 for mobility, -0.11 for usual activities and self-care, -0.09 for pain/discomfort, and -0.34 for anxiety/depression on day 14, respectively. Similar results were observed on day 90. Additionally, there was statistically significant difference of changes in EQ-VAS between the GDLM group and the placebo group from baseline to day 14 (mean difference, 1.70; 95% confidence interval [CI], 0.78-2.62; P = 0.0003) and to day 90 after randomization (mean difference, 3.29; 95% CI, 2.37-4.22; P < 0.001).

Conclusions: In this analysis of Chinese patients with AIS, GDLM could improve the 14-day and 90-day quality of life compared with the placebo.

Trial registration: URL: https://www.

Clinicaltrials: gov . Unique identifier: NCT02526225. Registration Date: 2016-02-01.

Background: Despite being a widely used generic measure of health-related quality of life worldwide, there is limited evidence on the psychometric properties of the EuroQoL Five-dimensions five level (EQ-5D) among cervical cancer patients in Ethiopia.

Objective: To evaluate psychometric properties of the Amharic version of EQ-5D among Ethiopian cervical cancer patients.

Methods: A longitudinal survey of cervical cancer patients receiving treatment at two Ethiopian tertiary care facilities was conducted from March 2022 to July 2023. Participants completed the EQ-5D and the European Organization for Research and Therapy of Cancer (EORTC QLQ-C30) at baseline and after three months on treatment. Effect size and standardized response mean were used to assess responsiveness. Anchor-based and distribution-based methods were used to calculate the minimal clinically important difference (MCID). Minimal detectable change (MDC) ratios were computed at the individual and group levels. Statistical significance was determined at p < 0.05.

Results: Three hundred seventy-one patients completed the survey at baseline and follow-up with a mean age of 49.72 (10.80) years. The majority (268,73%) of the patients had early-stage cancer. The EQ-5D index and EQ VAS scores respectively improved by 0.04 and 7.0 post-treatment.The physical domains of EORTC QLQ-C30 had showed high correlation with physical dimensions of EQ-5D (r > 0.6) and the instrument showed good discriminate validity between patients with different health states. The effect size ranged between - 0.12 and 0.60 for the EQ-5D index value and - 0.12 to 1.16 for the EQ VAS, indicating small to large responsiveness. The average (range) MCID value of the EQ-5D index was 0.10-0.15. The findings showed that MCID to MDC ratios at the group level were more clinically meaningful than the individual level.

Conclusion: The EQ-5D effectively detected changes and discriminate patients with different levels of health. While group-level MCIDs were established in this study, further studies are recommended to prove its usefulness at the individual-level.

Introduction: Haemophilia is a rare bleeding disorder caused by a deficient or absent clotting factor, leading to frequent bleeding. Multiple intravenous (IV) infusions have been the standard prophylactic treatment; however, newer treatment options involve less frequent subcutaneous (SC) injections. To inform future health economic evaluations, this study applied the time trade-off (TTO) method for estimation of utilities associated with haemophilia treatment for both people with the disease and potential caregivers.

Methods: Using the TTO method, utilities were estimated through two online surveys distributed in the UK, Canada and the US. In survey 1 (S1), adults from the general population aged 18 years and above evaluated health states as if they were living with haemophilia themselves and were receiving treatment for the condition. In survey 2 (S2), adults from the general population with a child under the age of 15 years evaluated health states as if they were treating their child for haemophilia. The surveys assessed the following treatment aspects: frequency of treatment, treatment device and injection site reactions.

Results: In total, 812, 739 and 703 respondents completed S1 and 712, 594 and 527 completed S2 in the UK, Canada and the US, respectively. In both surveys, the treatment device was associated with the largest impact on utilities for both people with haemophilia and caregivers. Monthly SC injections with a prefilled pen-device were associated with a significant utility gain compared with SC injections with a syringe and IV infusions. In S1, a lower treatment frequency was preferred in all three countries, while in S2, a lower treatment frequency was preferred only in the UK. Avoiding injection site reactions was associated with a significant utility gain in both surveys, but only in the UK and Canada.

Conclusions: The study suggests that the administration of haemophilia treatment in particular has an impact on utilities for both people and caregivers living with the disease. Thus, less complex and time-consuming treatment devices are expected to improve health-related quality of life. This can be further modified additively by less frequent administration. These results can inform future health economic analyses of haemophilia and haemophilia treatment.

Purpose: To evaluate measurement properties of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) instrument among Chinese overweight and obese populations.

Methods: A representative sample of Chinese overweight and obese populations was recruited stratified by age, sex, residence and body mass index (BMI). Social-demographic characteristics, self-reported EQ-5D-5 L and IWQOL-Lite responses were collected through the online survey. Test-retest reliability was assessed using intraclass correlation coefficient (ICC) among a subgroup of the total sample. Structural validity was evaluated by confirmatory factor analysis (CFA). Convergent validity and known-group validity were examined using Spearman's rank correlation and effect sizes, respectively.

Results: A total of 1000 respondents (48% female; mean age: 51.7 years; mean BMI: 27.4) were included in this study. Ceiling and floor effects of the IWQOL-Lite were 5.4% and 0.67%, respectively. The ICC between the two tests was 0.992 for IWQOL-Lite among the subgroup (N = 150). The results of the CFA suggested that the five-factor model had an acceptable structural validity (GFI = 0.894, CFI = 0.960, TLI = 0.957, RMSEA = 0.054 and SRMR = 0.033). The Spearman's rank correlation (range: 0.413-0.611) indicated a satisfactory convergent validity. The effect sizes values of IWQOL-Lite total score and different dimensions were moderate.

Conclusions: The IWQOL-Lite has been demonstrated to have satisfactory validity and reliability in measuring the HRQoL of Chinese overweight and obese populations. Further research is needed to confirm the sensitivity and responsiveness.

Background: Health-related quality of life (HRQoL) is a crucial patient-centred outcome for developing policy. However, there is a lack of appropriate HRQoL measures for young children (0-5-years), who are particularly vulnerable to respiratory illnesses like pulmonary tuberculosis (PTB) and other respiratory infections, especially in low- and middle-income countries (LMICs). We aimed to develop a disease-specific HRQoL item bank for young children with acute and chronic respiratory illnesses.

Methods: An exploratory sequential design with three phases was used to develop a HRQoL item bank. The content validity of the item bank was evaluated by local and international experts specialising in HRQoL and child health. The group included paediatric pulmonologists, researchers with expertise in respiratory illnesses, and experts in scale development. Cognitive interviews with 37 caregivers of children with TB, pneumonia, adenovirus respiratory infection, other lower respiratory tract infections, reactive airway disease, and protracted bronchitis in Cape Town, South Africa, and consultations with 22 stakeholders were conducted for final revisions. The item bank was progressively refined at each phase of the study.

Findings: The Delphi experts recommended dividing the item bank into two age groups (0-2-years and 3-5-years) and using a 5-point Likert scale. Overall, 41 items (42%) met the predetermined > 70% threshold for inclusion in the item bank. Cognitive interviews confirmed that the domains were relevant. Minor modifications were made to five items in cohort 1 (0-2-years) and seven in cohort 2 (3-5-years), with 8 items (13%) and 14 items (22%) excluded. Phase 3 consultations emphasised the importance of including all seven domains and expanding the items to cover early childhood development, play, social interactions, and care routines. The final item bank includes versions for both age groups and incorporates these refinements.

Conclusion: An item bank was developed as a first step to develop a comprehensive disease-specific HRQoL tool for young children with respiratory illnesses in an LMIC. Input from caregivers and content experts was crucial in creating two HRQoL item banks tailored to the developmental differences between 0 and 2 and 3-5-year age groups. Their contributions ensured the tool effectively captures age-appropriate aspects of HRQoL. Future studies should focus on assessing the validity and reliability of these item banks.