EQ-5D-5L Research Articles

Quality of Life After Bladder Cancer: A Cross-sectional Survey of Patient-reported Outcomes

BackgroundLittle is known about health-related quality of life (HRQOL) following treatment for bladder cancer (BC). ObjectiveTo determine this, we undertook a cross-sectional survey covering 10% of the English population. Design, setting, and participantsParticipants 1–10 yr from diagnosis were identified through national cancer registration data. InterventionA postal survey was administered containing generic HRQOL and BC-specific outcome measures. Findings were compared with those of the general population and other pelvic cancer patients. Outcome measurements and statistical analysisGeneric HRQOL was measured using five-level EQ-5D (EQ-5D-5L) and European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30. BC-specific outcomes were derived from EORTC QLQ-BLM30 and EORTC QLQ-NMIBC24. Results and limitationsA total of 1796 surveys were completed (response rate 55%), including 868 (48%) patients with non–muscle-invasive BC, 893 (50%) patients who received radiotherapy or radical cystectomy, and 35 (1.9%) patients for whom treatment was unknown. Most (69%) of the participants reported at least one problem in any EQ-5D dimension. Age/sex-adjusted generic HRQOL outcomes were similar across all stages and treatment groups, whilst problems increased with age (problems in one or more EQ-5D dimensions: <65 yr [67% {95% confidence interval or CI: 61–74}] vs 85+ yr [84% {95% CI: 81–89}], p = 0.016) and long-term conditions (no conditions [53% {95% CI: 48–58}] vs more than four conditions [94% {95% CI: 90–97}], p < 0.001). Sexual problems were reported commonly in men, increasing with younger age and radical treatment. Younger participants (under 65 yr) reported more financial difficulties (mean score 20 [95% CI: 16–25]) than those aged 85+ yr (6.8 [4.5–9.2], p < 0.001). HRQOL for BC patients (for comparison, males with problems in one or more EQ-5D dimensions 69% [95% CI: 66–72]) was significantly worse than what has been found after colorectal and prostate cancers and in the general population (51% [95% CI: 48–53], all p < 0.05). ConclusionsHRQOL following BC appears to be relatively independent of disease stage, treatment, and multimodal care. Issues are reported with sexual function and financial toxicity. HRQOL after BC is worse than that after other pelvic cancers. Patient summaryPatients living with bladder cancer often have reduced quality of life, which may be worse than that for other common pelvic cancer patients. Age and other illnesses appear to be more important in determining this quality of life than the treatments received. Many men complain of sexual problems. Younger patients have financial worries.

Comparing patient-reported outcomes across countries: An assessment of methodological challenges.

ObjectivesThere is little published literature on the comparison of patient-reported outcomes between countries. This study aimed to assess pre- and postoperative health among samples of patients undergoing elective groin hernia repair procedures in the National Health Service (NHS), England, and groin hernia patients in Vancouver, Canada.MethodsWe used datasets from two different sources. For the English NHS we used published anonymized patient-level data files which include the EQ-5D(3L) patient-reported outcome measure and a number of demographic and clinical characteristics. For Vancouver, we used data from a sample of Vancouver patients who completed the same instrument during a similar time frame. English patients were matched with Vancouver participant’s characteristics using propensity score methods. A linear regression model was used to measure differences in postoperative visual analogue scale values between countries, adjusting for patient characteristics.ResultsOur study revealed a range of methodological issues concerning the comparability of patient-reported outcomes following hernia repair surgery in the two health systems. These related to differences in approaches to collecting patient-reported outcome measures and the nature of explanatory variables (self-report vs. administrative data), among other challenges. As a consequence, there were differences between the matched samples and the NHS data, indicating a healthy participant bias. Unadjusted results found that Vancouver patients (N = 280) reported more problems in domains of mobility, self care, usual activities and anxiety/depression than the matched cohort of NHS patients (N = 840). Interpreting differences is challenging given different sampling designs.ConclusionsThere are significant hurdles facing comparisons of surgical patients’ outcomes between countries, including adjusting for patient differences, health system factors and approaches to survey administration. While between-country comparisons of surgical outcomes using patient-reported outcomes shows significant promise, much work on standardizing sampling design, variables and analytic methods is needed.

The measurement performance of the EQ-5D-5L versus EQ-5D-3L in patients with hidradenitis suppurativa

PurposeHidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects up to 1% of the population in Europe. The EQ-5D is the most commonly used generic instrument for measuring health-related quality of life among HS patients. This study aims to compare the measurement properties of the two adult versions of EQ-5D (EQ-5D-3L and EQ-5D-5L) in patients with HS.MethodsWe recruited 200 consecutive patients with HS (mean age 37 years, 38% severe or very severe HS) to participate in a multicentre cross-sectional survey. Patients completed the EQ-5D-3L, EQ-5D-5L, Dermatology Life Quality Index (DLQI) and Skindex-16 questionnaires.ResultsMore than twice as many different health state profiles occurred in the EQ-5D-5L compared to the EQ-5D-3L (101 vs. 43). A significant reduction in ceiling effect was found for the mobility, self-care and usual activities dimensions. A good agreement was established between the EQ-5D-3L and EQ-5D-5L with an intraclass correlation coefficient of 0.872 (95% CI 0.830–0.903; p < 0.001) that was confirmed by a Bland-Altman plot. EQ-5D-5L improved both the absolute and relative informativity in all dimensions except for anxiety/depression. EQ-5D-3L and EQ-5D-5L demonstrated similar convergent validity with DLQI and Skindex-16. EQ-5D-5L was able to better discriminate between known groups of patients based on the number of comorbidities and disease severity (HS-Physician's Global Assessment).ConclusionIn patients with HS, the EQ-5D-5L outperformed the EQ-5D-3L in feasibility, ceiling effects, informativity and known-groups validity for many important clinical characteristics. We recommend using the EQ-5D-5L in HS patients across various settings, including clinical care, research and economic evaluations.

The dual presence of frailty and locomotive syndrome is associated with a greater decrease in the EQ-5D-5L index.

ABSTRACTJapan’s aging society is facing an increase in the prevalence of frailty and locomotive syndrome (LS) among older adults. To evaluate the association of these age-related declines on health-related quality of life (QOL) in Japan, we investigated this relationship among Japanese middle-aged and older adults who underwent general checkups and examined whether LS or frailty has a stronger association with the Japanese version of EuroQol’s five-level EQ-5D (EQ-5D-5L) index. Participants were 231 middle-aged and older Japanese adults receiving routine health checkups. The study utilized the 25-item Geriatric Locomotive Function Scale, the Japanese version of the Cardiovascular Health Study, and the Japanese version of the EQ-5D-5L. Univariate and multivariate analyses were performed to examine how frailty and LS are related to the EQ-5D-5L index. Patients with both frailty (p = 0.003) and LS (p < 0.001) had a significantly lower EQ-5D-5L index. After adjusting for age, gender, and body mass index, LS was significantly associated with a decrease in the EQ-5D-5L index (p < 0.001), whereas frailty had no significant association with the EQ-5D-5L index (p = 0.052). Further analysis showed no significant decrease in the EQ-5D-5L index among those with frailty but no LS, and a significant decrease among those with frailty and LS. The results suggest that frailty and LS are associated with a decrease in the EQ-5D-5L index, but LS has a more pronounced effect. In evaluating frailty’s effects on health-related QOL, we determined the importance of separately assessing frailty both with and without LS, even within the same frailty group.

Measuring the impact of delayed access to elective cholecystectomy through patient's cost-utility: an observational cohort study.

BackgroundDeferral of surgeries due to COVID-19 has negatively affected access to elective surgery and may have deleterious consequences for patient’s health. Delays in access to elective surgery are not uniform in their impact on patients with different attributes. The objective of this study is to measure the change in patient’s cost utility due to delayed elective cholecystectomy.MethodsThis study is based on retrospective analysis of a longitudinal sample of participants who have had elective cholecystectomy and completed the EQ-5D(3L) measuring health status preoperatively and postoperatively. Emergent cases were excluded. Patients younger than 19 years of age, unable to communicate in English or residing in a long-term care facility were ineligible. Quality-adjusted life years attributable to cholecystectomy were calculated by comparing health state utility values between the pre- and postoperative time points. The loss in quality-adjusted life years due to delayed access was calculated under four assumed scenarios regarding the length of the delay. The mean cost per quality-adjusted life years are shown for the overall sample and by sex and age categories.ResultsAmong the 646 eligible patients, 30.1% of participants (N = 195) completed their preoperative and postoperative EQ-5D(3L). A delay of 12 months resulted in a mean loss of 6.4%, or 0.117, of the quality-adjusted life years expected without the delay. Among patients older than 70 years of age, a 12-month delay in their surgery corresponded with a 25.1% increase in the cost per quality-adjusted life years, from $10 758 to $13 463.ConclusionsThere is a need to focus on minimizing loss of quality of life for patients affected by delayed surgeries. Faced with equal delayed access to elective surgery, triage may need to prioritize older patients to maximize their health over their remaining life years.

The minimally important difference of the Gastrointestinal Quality of Life Index for symptomatic gallstone surgery

IntroductionThe Gastrointestinal Quality of Life Index (GQLI) is used to measure domains of health and symptoms among people with gastrointestinal disorders. The objective of this study is to calculate the smallest change in the GQLI that is perceived by patients as meaningful among a sample of English-speaking adult patients undergoing elective laparoscopic cholecystectomy for treatment of symptomatic gallbladder disease.Materials and methodsThe study is based on retrospective analyses of a sample of participants completing the GQLI and the EQ-5D(3L) preoperatively and six months postoperatively in Vancouver, Canada. Patients are excluded if they are less than 19 years of age, cannot communicate in English, or reside in a long-term care facility. The MID is calculated for the GQLI’s domains using distribution and anchor-based methods.ResultsAmong eligible patients, the participation rate was 51%. The estimated MID for the overall GQLI value ranged between 4.32 and 11.44. There were no statistically significant differences in the GQLI’s MID values between sexes or age subgroups. There were statistically significant differences in the GQLI’s MID values by baseline health status.DiscussionThis study should provide some comfort that the MID values used in discussing change in health and symptoms with elective cholecystectomy patients are robust to sex. Although the sample size may have been inadequate for age-based analyses, the study found large differences in MID values between age subgroups. Statistically significant differences in MID values based on preoperative health supports reporting MID values separately by baseline value. Further research should explore whether age-based differences in MID values exist using larger samples.

Health Economic Evaluation of Patients with Colorectal Liver Metastases Randomized to ALPPS or TSH - Analysis from the LIGRO Trial

Introduction: Two-staged hepatectomy (TSH), is an established method in advanced colorectal liver metastases (CRLM). Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) has emerged providing improved resection rate and survival. The health care costs and health outcomes, combining health related quality of life (HRQoL) and survival into quality-adjusted life years (QALYs), of ALPPS and TSH have not previously been evaluated and compared. Methods: This is a pre-planned, health economic evaluation from the LIGRO trial. One hundred patients with CRLM and standardized FLR < 30 % were randomized to ALPPS or TSH. Costs and QALYs were compared from treatment start up to 2 years. Costs are estimated from resource use, including all surgical interventions, length of stay after interventions, diagnostic procedures and chemotherapy and applying Swedish unit costs. QALYs were estimated by combining survival and HRQoL data, the latter being assessed with EQ-5D 3L. Estimated costs and QALYs for each treatment strategy were combined into an incremental cost-effectiveness ratio (ICER). Non-parametric bootstrapping was used to assess the joint distribution of incremental costs and QALYs. Results: The mean cost difference between ALPPS and TSH was 12662€, (95% CI -10728-36051, p=0.283). Corresponding mean difference in life years and QALYs was 0.1296 (95% CI -0.12-0.38, p=0.314) and 0.1285 (95% CI -0.11-0.36, p=0.28), respectively. The ICER was 93186 and 92414 for QALYs and life-years as outcomes, respectively. Conclusion: Based on the two-year data, the cost-effectiveness of ALPPS is uncertain. Further research, exploring cost and health outcomes beyond 2 year is needed.

Generic and Respiratory-Specific Quality of Life in Non-Hospitalized Patients with COVID-19.

The impact of coronavirus disease 2019 (COVID-19) on quality of life appears to be highly underestimated, especially in patients who have not been admitted to the hospital. Therefore, our aim was to assess respiratory-specific quality of life in addition to generic quality of life in former patients with confirmed/suspected COVID-19 who have never been admitted to the hospital. Members of an online Belgian social support group for patients with confirmed/suspected COVID-19 with persistent complaints, completed an online survey. The five-level EQ-5D (EQ-5D-5L) and the Clinical COPD Questionnaire (CCQ) were used to assess generic and respiratory-specific quality of life, respectively. Data of 210 non-hospitalized patients (88% women, 45 ± 11 years, 79 ± 17 days after symptom onset) were included in the analyses. Mean EQ-5D index and visual analogue scale (EQ-VAS) score was 0.62 ± 0.19 and 50.71 ± 18.87, respectively, with 40% of the patients demonstrating an EQ-5D index that was below the fifth percentile of normative values, indicating poor generic quality of life. The mean CCQ score was 2.01 ± 0.98 points, while 123 respondents (59%) had a total score ≥1.9 points, indicating poor respiratory-specific quality of life. The correlation between EQ-5D index score/EQ-VAS score and CCQ total score was moderate (r = −0.524 and r = −0.374; both p < 0.001). In conclusion, both generic and respiratory-specific quality of life are affected in non-hospitalized patients with COVID-19, approximately three months after the onset of symptoms. The combined use of the EQ-5D and the CCQ could identify the broad impact of COVID-19 on quality of life.

PCN295 Health State Utility Values By Time to Death in Recurrent or Metastatic Squamous-Cell Carcinoma of the Head and Neck

Cost-utility analysis is the preferred form of economic evaluation for the majority of reimbursement agencies. This analysis aimed to estimate utilities based on time-to-death (TTD) periods associated with recurrent or metastatic squamous-cell carcinoma of the head and neck (SCCHN). Utilities were generated using patient-level data of the CheckMate 141 trial (NCT02105636; December 2015 data cut) of nivolumab versus investigator’s choice using the three-level EQ-5D (EQ-5D-3L) and UK value set. TTD periods were defined in line with prior approaches to TTD-based utility values and modified based on data availability (Model 1: ≥183 days, 92-182 days, 0-91 days; Model 2: 57-91 days, 29-56 days, 0-28 days). Utility values were estimated using linear mixed models with a fixed effect of TTD period and random intercept for each patient. Treatment-independent and treatment-specific (incorporating fixed effects of treatment and its interaction with TTD period) utilities were estimated. 502 observations from 273 patients could be assigned to a TTD period. Estimated treatment-independent utilities were: ≥183 days (n=135, 0.694 [95% CI 0.652, 0.736]), 92-182 days (n=81, 0.651 [95% CI 0.594, 0.707]), 0-91 days (n=118, 0.510 [95% CI 0.461, 0.560]). Splitting the final 3 months prior to death yielded the following utilities: 57-91 days (n=63, 0.569 [95% CI 0.484, 0.655]), 29-56 days (n=40, 0.487 [95% CI 0.378, 0.596]), 0-28 days (n=33, 0.422 [95% CI 0.302, 0.541]). Treatment-specific utilities showed a similar trend of decreasing utilities closer to death in a near-linear fashion; however, sample sizes became small for the final TTD periods. This study estimated TTD-based utility values in SCCHN. Utility values decreased in a monotonic trend in accordance with closer TTD, especially in the final 3 months prior to death. These values can support cost-utility analyses as a supplementary alternative to the more commonly applied progression-based models.

The Effect of Minimally Invasive Surgery and Sternotomy on Physical Activity and Quality of Life

The aim of this study was to compare minimally invasive surgery (MI) and median sternotomy (MS) in terms of post-procedure health-related quality of life (HRQoL) and functional outcome. We conducted a multicentre prospective cohort study that enrolled patients from January 2015 until February 2017. Combined cardiac procedures were performed with MS and isolated valve procedures with either MS or MI, depending on patient preference and surgeon experience. HRQoL was measured using the five-level version of the EQ-5D (EQ-5D-5L) and physical activity before and after surgery was evaluated using a wearable accelerometer. Activity patterns and intensity recorded by the accelerometer in each period were classified as "sedentary", "light physical activity", "moderate physical activity", and "vigorous physical activity" for each patient. We also conducted a sub-analysis of frail patients in each group, as identified by the Reported Edmonton Frail Scale (>10 points). Patients were followed for 1 year. The study included 100 consecutive patients who underwent MI (n=50) or MS (n=50) during the study period. Patients in the MI group showed a faster recovery of physical activity in the immediate postoperative period and superior HRQoL in the first 3 months (both p<0.001) versus the MS group. Differences between the MI and MS group were indistinguishable over a longer follow-up. A similar correlation was observed in the frailty subanalysis. Overall, the MS group had a higher cumulative incidence of events than the MI group (p<0.001). Compared to conventional MS, MI was associated with better HRQoL and early functional outcome, even in frail patients.

Health utility of type 2 diabetes patients using basal insulin in China: results from the BEYOND II study.

To derive the health utility scores of type 2 diabetes (T2D) patients using basal insulin (BI) with diverse characteristics in China. The study used the data of insulin-using T2D patients on BI treatment enrolled in the BEYOND II study, which is a multi-center, observational study from 78 hospitals nationwide. The 3-level EQ-5D (EQ-5D-3L) questionnaire was administered to each patient to derive their health utility scores using the EQ-5D-3L value set for China. Patients' clinical and sociodemographic information were retrieved from their electronic case report form (eCRF). Ordinary least-square models with different specifications were explored to identify the best-fitting model to predict the utility scores. The sample (n = 12,583) achieved a mean (standard deviation) EQ-5D-3L utility score of 0.936 (0.120). According to the model, a Chinese male who was younger than 59years, not underweight, diagnosed with T2D shorter than 10years, with controlled plasma glucose and free of diabetes complications/comorbidities, would have a mean utility of 0.993. Being female, older age, underweight, and higher plasma glucose, longer diabetes duration was negatively related to EQ-5D-3L scores. Comorbidities and seven of eleven complications were associated with utility decrement. Interactions between some complications were also discovered. The derived health utility scores for diabetes complications could facilitate the assessment of the cost-effectiveness of health interventions for Chinese insulin-using T2D patients.

Identifying the Value of an eHealth Intervention Aimed at Cognitive Impairments: Observational Study in Different Contexts and Service Models.

BackgroundValue is one of the central concepts in health care, but it is vague within the field of summative eHealth evaluations. Moreover, the role of context in explaining the value is underexplored, and there is no explicit framework guiding the evaluation of the value of eHealth interventions. Hence, different studies conceptualize and operationalize value in different ways, ranging from measuring outcomes such as clinical efficacy or behavior change of patients or professionals to measuring the perceptions of various stakeholders or in economic terms.ObjectiveThe objective of our study is to identify contextual factors that determine similarities and differences in the value of an eHealth intervention between two contexts. We also aim to reflect on and contribute to the discussion about the specification, assessment, and relativity of the “value” concept in the evaluation of eHealth interventions.MethodsThe study concerned a 6-month eHealth intervention targeted at elderly patients (n=107) diagnosed with cognitive impairment in Italy and Sweden. The intervention introduced a case manager role and an eHealth platform to provide remote monitoring and coaching services to the patients. A model for evaluating the value of eHealth interventions was designed as monetary and nonmonetary benefits and sacrifices, based on the value conceptualizations in eHealth and marketing literature. The data was collected using the Mini–Mental State Examination (MMSE), the clock drawing test, and the 5-level EQ-5D (EQ-5D-5L). Semistructured interviews were conducted with patients and health care professionals. Monetary data was collected from the health care and technology providers.ResultsThe value of an eHealth intervention applied to similar types of populations but differed in different contexts. In Sweden, patients improved cognitive performance (MMSE mean 0.85, SD 1.62, P<.001), reduced anxiety (EQ-5D-5L mean 0.16, SD 0.54, P=.046), perceived their health better (EQ-5D-5L VAS scale mean 2.6, SD 9.7, P=.035), and both patients and health care professionals were satisfied with the care. However, the Swedish service model demonstrated an increased cost, higher workload for health care professionals, and the intervention was not cost-efficient. In Italy, the patients were satisfied with the care received, and the health care professionals felt empowered and had an acceptable workload. Moreover, the intervention was cost-effective. However, clinical efficacy and quality of life improvements have not been observed. We identified 6 factors that influence the value of eHealth intervention in a particular context: (1) service delivery design of the intervention (process of delivery), (2) organizational setup of the intervention (ie, organizational structure and professionals involved), (3) cost of different treatments, (4) hourly rates of staff for delivering the intervention, (5) lifestyle habits of the population (eg, how physically active they were in their daily life and if they were living alone or with family), and (6) local preferences on the quality of patient care.ConclusionsValue in the assessments of eHealth interventions need to be considered beyond economic terms, perceptions, or behavior changes. To obtain a holistic view of the value created, it needs to be operationalized into monetary and nonmonetary outcomes, categorizing these into benefits and sacrifices.

Primary versus recurrent surgery for glioblastoma\u2014a prospective cohort study

BackgroundThere is currently limited evidence for surgery in recurrent glioblastoma (GBM). Our aim was to compare primary and recurrent surgeries, regarding changes in perioperative, generic health-related quality of life (HRQoL), complications, extents of resection and survival.MethodsBetween 2007 and 2018, 65 recurrent and 160 primary GBM resections were prospectively enrolled. HRQoL was recorded with EQ-5D 3L preoperatively and at 1 month postoperatively. Median perioperative change in HRQoL and change greater than the minimal clinically important difference (MCID) were assessed. Tumour volume and extent of resection were obtained from pre- and postoperative MRI scans. Survival was assessed from date of surgery.ResultsComparing recurrent surgeries and primary resections, most variables were balanced at baseline, but median age (59 vs. 62, p = 0.005) and median preoperative tumour volume (14.9 vs. 25.3 ml, p = 0.001) were lower in recurrent surgeries. There were no statistically significant differences regarding complication rates, neurological deficits, extents of resection or EQ-5D 3L index values at baseline and at follow-up. Twenty (36.4%) recurrent resections vs. 39 (27.5%) primary resections reported clinically significant deterioration in HRQoL at follow-up. Stratified by clinically significant change in EQ-5D 3L, the survival distributions were not statistically significantly different in either group. Survival was associated with extent of resection (p = 0.015) in recurrent surgeries only.ConclusionsOutcomes after primary and recurrent surgeries were quite similar in our practice. As surgery may prolong life in patients where gross total resection is obtainable with reasonable risk, the indication for surgery in GBM should perhaps not differ that much in primary and recurrent resections.

A Home Based Telerehabilitation Exercise Program For Heart Failure Patients - Changes In Quality Of Life

Heart failure (HF) patients are strongly recommended to participate in cardiac rehabilitation programs. Due to frailty and rural living, many HF patients refuse to do so. A home based telerehabilitation program was designed to enable heart failure patients to exercise via video-conferencing in their homes. Video-conferencing allowed for two-way communication and for patients to exercise together. PURPOSE: This project aims to study the changes in quality of life in HF patients undertaking a telerehabilitation intervention, compared to controls. METHODS: 67 patients were randomized into an exercise or control group if they had stable HF, were medically optimized, and refused to participate in standard outpatient rehabilitation. The exercise group received telerehabilitation for 3 months. Both groups participated in a 2-day “Living with HF” course. The EQ-5D (5L), and the Minnesota living with heart failure Questionnaire (MLHFQ) were administered to all participants before and after the intervention period. Patients were included in this analysis if they completed the EQ-5D and MLHFQ at baseline (BL) and at 3-month follow-up. RESULTS: Mean age was 68 (65.6-71.1) years (82 % male). There was a significant decrease in EQ-5D score for the exercise group from BL to 3md follow-up (-1.23), p=0.015. The decrease was not significant for the control group (-0.59), p=0.077. Still, there was no significant difference between groups regarding changes in EQ-5D score for the exercise (-1.23, SD 2.41) and control groups (-0.59, SD 1.67), p=0.27, or between groups regarding change in the EQ-5D VAS-score for exercise (5.18, SD 13.64) and control groups (5.48, SD 16.35), p=0.95. We found a significant decrease in MLHFQ score for the exercise group from BL to 3md follow-up (-13.8), p=0.003, and for the control group (-12.56), p=0.002. Still, there was no significant difference between groups regarding change in MLHFQ score for the exercise group (-13.8, SD 21.23) and the controls (-12.56, SD 19.08), p=0.83. CONCLUSIONS: Both groups seem to increase the quality of life by participating in this study. This might be due to the attention by attending a study, coming to regular follow-ups, or information and motivation gained during the 2-day “living with HF” course.

A study on the quality of life of patients awaiting knee replacement in the population of central Poland

Introduction. Quality of life is a multidimensional and subjectively perceived concept. One of the main reasons for its decrease is osteoarthritis. Aim. The aim of this study was to analyze factors affecting the quality of life in the group of patients with knee osteoarthritis while waiting for TKA surgery. Material and methods. The study was conducted on 66 patients living in central Poland with diagnosed osteoarthritis of the knee (M17.0). The quality of life was assessed with the use of EQ-5D 5L instrument, EQ-VAS and the author’s questionnaire. The research was carried out at the Department of Trauma and Orthopaedic Surgery in Belchatow. The following variables were statistically analyzed: body weight (BMI), the need for orthopaedic aids (elbow crutches or a walker), condition of the other knee (healthy, after endoprosthesis, degenerated). Results. All patients with knee osteoarthritis have lower assessment of their own health. Body mass index (BMI) and the need for orthopaedic aids do not affect the quality of life. Statistically significant differences were found in the condition of the other knee- in patients with healthy joint or after knee arthroplasty quality of life was higher mainly in terms of self-care, mobility and general health assessment than in the case of a joint with osteoarthritis. Conclusions. The quality of life in population awaiting for TKA due to osteoarthritis is markedly reduced and correlates with the condition of the other knee joint, whereas it shows no relationship with body weight or the need for orthopedic aids.

Safety profile of ripretinib, including impact of alopecia, and Palmar-Plantar Erythrodysesthesia Syndrome (PPES) on patient-reported outcomes (PROs), in ≥ fourth-line advanced gastrointestinal stromal tumors (GIST): Analyses from INVICTUS.

11539 Background: Ripretinib is a novel switch-control TKI that broadly inhibits KIT and PDGFRA kinase signaling. In INVICTUS (NCT03353753), a randomized, double-blind, placebo (PBO)-controlled trial of ripretinib in ≥4th-line advanced GIST, ripretinib reduced the risk of disease progression or death by 85% vs PBO with a favorable overall safety profile. Common ( &gt; 20%) adverse events (AEs) included, but were not limited to, alopecia and PPES. Exploratory analyses evaluated the impact of alopecia and PPES on quality of life (QoL). Methods: Patients (pts) with advanced GIST previously treated with at least imatinib, sunitinib, and regorafenib were randomized (2:1) to ripretinib 150 mg QD or PBO. AEs were graded using CTCAE v4 and PROs collected using EQ-5D-5L (EQ5D) and EORTC QLQ-C30 (C30). Repeated measures (RM) models assessed the impact of alopecia and PPES on 5 PROs (EQ5D visual analogue scale; and C30 physical functioning, role functioning, and the overall health and overall QoL questions) within the ripretinib arm. Fixed effects were sex, alopecia/PPES, and ECOG scores at baseline. Results: 128/129 randomized pts received treatment (85 ripretinib 150 mg QD; 43 PBO). Alopecia, regardless of causality, occurred in 44 (51.8%) on ripretinib (34 [40.0%] grade 1; 10 [11.8%] grade 2) and 2 (4.7%) on PBO (both grade 1). PPES occurred in 18 (21.2%) on ripretinib (11 [12.9%] grade 1; 7 [8.2%] grade 2); none on PBO. The median times in days to first occurrence and worst severity grade with ripretinib were 57.0 and 62.5 for alopecia; 56.5 and 57.0 for PPES. The RM models showed a slight trend towards improvement in PRO score over time for pts with alopecia; the only association reaching a P-value of &lt; 0.05 was between alopecia and increased overall QoL. None of the associations between PPES and PRO scores reach P &lt; 0.05. All PRO p-values are nominal, and no statistical significance is being claimed. Conclusions: Ripretinib had a favorable overall safety and tolerability profile. When stratified by alopecia and PPES, patient-reported assessments of function, overall health, and overall QoL were maintained over time. For both alopecia and PPES, onset and maximum severity occurred almost simultaneously, indicating that these events generally did not progressively worsen. These results suggest that alopecia and PPES are manageable and do not have a negative effect on function, overall health, and QoL. Clinical trial information: NCT03353753 .

Quality of life (QoL) and self-reported function with ripretinib in ≥4th-line therapy for patients with gastrointestinal stromal tumors (GIST): Analyses from INVICTUS.

11535 Background: Ripretinib is a novel switch-control tyrosine kinase inhibitor (TKI) that broadly inhibits KIT and PDGFRA kinase signaling through a dual mechanism of action. In INVICTUS (NCT03353753), a randomized, double-blind, placebo-controlled trial of ripretinib in ≥4th-line advanced GIST, ripretinib reduced the risk of disease progression or death by 85% vs placebo and had a favorable overall safety profile in patients previously treated with ≥3 prior TKIs. Methods: As part of the INVICTUS trial, patient reported outcome (PRO) measures were collected using EQ-5D-5L (EQ5D) and EORTC QLQ-C30 (C30). In prespecified and additional analyses, ANCOVA models were built to compare changes from baseline to cycle 2 day 1 (C2D1) for PRO measures within the ripretinib and placebo arms and determine the difference between treatment arms. PRO measures included the EQ5D visual analogue scale (VAS) and the C30 physical functioning (PF) and role functioning (RF) scales (all scores range from 0–100; higher scores are better). The C30 overall health and overall QoL questions were also assessed (scores range from 1–7; higher scores are better). Fixed effects included treatment arm, number of previous anticancer treatments (3 vs ≥4), and ECOG score at baseline (0 vs 1/2). Results: Overall, 129 patients were randomized and 128 received treatment (85 to ripretinib 150 mg QD; 43 to placebo). All PRO p-values are nominal, and no statistical significance is being claimed. VAS scores improved an average 3.7 points from baseline to C2D1 with ripretinib vs an average decline of 8.9 with placebo (P = 0.004; improvement or no change, 67% vs 41% of patients, respectively). Similarly, the average PF score improved 1.6 points with ripretinib and decreased 8.9 with placebo (P = 0.004; improvement or no change, 68% vs 44%). RF scores also improved an average of 3.5 points with ripretinib vs a decrease of 17.1 with placebo (P = 0.001; improvement or no change, 77% vs 50%). For the overall health and overall QoL questions, scores increased with ripretinib an average of 0.20 and 0.28, respectively, and decreased 0.78 and 0.76 with placebo (both P = 0.001; improvement or no change, 74% vs 47% and 79% vs 59%, respectively). Conclusions: Based on the 5 PRO measures assessed, when compared with placebo and best supportive care, ripretinib provided patient-benefit in advanced GIST with PRO measures of role and physical function, VAS, overall health, and overall QoL remaining stable. Clinical trial information: NCT03353753 .

Mapping the Chinese Version of the EORTC QLQ-BR53 Onto the EQ-5D-5L and SF-6D Utility Scores.

This study aimed to develop mapping algorithms from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BR53, including EORTC QLQ-C30 and QLQ-BR23) onto the 5-level EQ-5D (EQ-5D-5L) and Short Form 6D (SF-6D) utility scores. The data were taken from 607 breast cancer patients in mainland China. The EQ-5D-5L and SF-6D instruments were scored using Chinese-specific tariffs. Three model specifications and seven statistical techniques were used to derive mapping algorithms, including ordinary least squares (OLS), Tobit, censored least absolute deviation (CLAD) model, generalized linear model (GLM), robust MM-estimator, finite mixtures of beta regression model for directly estimating health utility, and using ordered logit regression (OLOGIT) to predict response levels. A five-fold cross-validation approach was conducted to test the generalizability of each model. Two key goodness-of-fit statistics (mean absolute error and mean squared error) and three secondary statistics were employed to choose the optimal models. Participants had a mean ± standard deviation (SD) age of 49.0 ± 9.8years. The mean ± SD health state utility scores were 0.828 ± 0.184 (EQ-5D-5L) and 0.646 ± 0.125 (SF-6D). Mapping performance was better when both the QLQ-C30 and QLQ-BR23 dimensions were considered rather than when either of these dimensions were used alone. The mapping functions from the optimal direct mapping and indirect mapping approaches were reported. The algorithms reported in this paper enable EORTC QLQ-BR53 breast cancer data to be mapped into utilities predicted from the EQ-5D-5L and SF-6D. The algorithms allow for the calculation of quality-adjusted life years for use in breast cancer cost-effectiveness analyses studies.

PCN317 ASSOCIATIONS BETWEEN THE EQ-5D-3L AND QLU-C10D DESCRIPTIVE SYSTEMS: USE OF CORRELATION NETWORKS TO EXPLORE PREFERENCE DIFFERENCES IN SOLID TUMOR TRIALS

Previous work on pooled data from five phase 3 nivolumab trials highlighted that use of the cancer-specific Quality of Life Utility Measure-Core 10 Dimensions (EORTC QLU-C10D) UK index yielded smaller quality-adjusted life year (QALY) differences between treatments than the generic 3-level EQ-5D (EQ-5D-3L) UK index on average. Since a cancer-specific utility measure might be expected to be more sensitive, this study aimed to explore the drivers of these differences.

HASTA GÜÇLENDİRME VE YAŞAM KALİTESİ İLİŞKİSİ

Amaç: Bu çalışmada hasta güçlendirme ve yaşam kalitesi arasındaki ilişkinin ve hastaların yaşam kalitesini etkileyen faktörlerin belirlenmesi amaçlanmıştır.Yöntem: Araştırmaya bir üniversite hastanesinde 5 Şubat-25 Mayıs 2018 tarihleri arasında dâhiliye, göğüs hastalıkları, kardiyoloji ve genel cerrahi birimlerinde poliklinik başvurusu yapan kronik hastalar dâhil edilmiştir. Astım, diyabet, kronik obstrüktif akciğer hastalığı (koah), tiroid ve kalp rahatsızlığı bulunan hastaların dâhil edildiği bu çalışmada Small (2012) tarafından geliştirilen, Kaya ve Işık (2018) tarafından Türkçe geçerlilik ve güvenilirliği yapılan hasta güçlendirme ölçeği kullanılmıştır. Hastaların yaşam kalitesi ise The Euro Qol Group tarafından geliştirilmiş olan EQ-5D 5L ölçeğinin Hollanda ağırlıkları ile uygulanması ile değerlendirilmiştir. Rastgele örnekleme yöntemi kullanılmıştır ve 515 hasta araştırmaya dâhil edilmiştir. Araştırmanın verileri SPSS 23 programı ile analiz edilmiştir. Bulgular: Uygulanan hasta güçlendirme ölçeğine ilişkin ortalama skor 130,18 olarak gerçekleşmiştir. Hasta güçlendirme ile yaşam kalitesi arasında orta düzeye yakın pozitif yönlü bir ilişki bulunmuştur. Ayrıca yaş grubu ve kronik hastalık türünün hasta güçlendirme ve yaşam kalitesi skoru üzerinde değişikliğe yol açtığı belirlenmiştir.Sonuç: Bu çalışmada hasta güçlendirme ile yaşam kalitesi arasında ilişki olduğu ve hasta güçlendirmenin yaşam kalitesini artırdığı sonucuna ulaşılmıştır. Bu yüzden hastaların güçlendirilmesine yönelik uygulamalara önem verilmesi, hastanın tedavisine aktif katılımının sağlanması ve uygulanacak politikaların bu doğrultuda planlanması önerilmektedir.