EuroQol-5 Dimensions-5 Levels Research Articles

Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study

BackgroundSOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data. ObjectiveTo analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation. Design, setting, and participantsTwenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 ± 3.7 mo. Outcome measurements and statistical analysisThe effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test. Results and limitationsAverage daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p < 0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p < 0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4 ± 15.3 mo. ConclusionsThis study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life. Patient summaryOur study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder.This trial is registered at ClinicalTrials.gov as NCT02186041.

Quality of Life Following Urgent LVAD Implantation for ECMO Therapy in Cardiogenic Shock: A Long-Term Follow-Up.

Background and Objectives: Over the past decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has developed into a mainstream treatment for refractory cardiogenic shock (CS) to maximal conservative management. Successful weaning of VA-ECMO may not be possible, and bridging with further mechanical circulatory support (MCS), such as urgent implantation of a left ventricular assist device (LVAD), may represent the only means to sustain the patient haemodynamically. In the recovery phase, many survivors are not suitably prepared physically or psychologically for the novel issues encountered during daily life with an LVAD. Materials and Methods: A retrospective analysis of our institutional database between 2012 and 2019 was performed to identify patients treated with VA-ECMO for CS who underwent urgent LVAD implantation whilst on MCS. Post-cardiotomy cases were excluded. QoL was assessed prospectively during a routine follow-up visit using the EuroQol-5 dimensions-5 level (EQ-5D-5L) and the Patient Health Questionnaire (PHQ-9) surveys. Results: Among 126 in-hospital survivors of VA-ECMO therapy due to cardiogenic shock without prior cardiac surgery, 31 (24.6%) urgent LVAD recipients were identified. In 11 (36.7%) cases, cardiopulmonary resuscitation (CPR) was performed (median 10, range 1–60 min) before initiation of VA-ECMO, and in 5 (16.7%) cases, MCS was established under CPR. Mean age at LVAD implantation was 51.7 (+/−14) years and surgery was performed after a mean 12.1 (+/−8) days of VA-ECMO support. During follow-up of 46.9 (+/−25.5) months, there were 10 deaths after 20.4 (+/−12.1) months of LVAD support. Analysis of QoL questionnaires returned a mean EQ-5D-5L score of 66% (+/−21) of societal valuation for Germany and a mean PHQ-9 score of 5.7 (+/−5) corresponding to mild depression severity. When compared with 49 elective LVAD recipients without prior VA-ECMO therapy, there was no significant difference in QoL results. Conclusions: Patients requiring urgent LVAD implantation under VA-ECMO support due to CS are associated with comparable quality of life without a significant difference from elective LVAD recipients. Close follow-up is required to oversee patient rehabilitation after successful initial treatment.

Patient activation and patient-reported outcomes of men from a community pharmacy lifestyle intervention after prostate cancer treatment

PurposeTo report patient activation, which is the knowledge, skills, and confidence in self-managing health conditions, and patient-reported outcomes of men after prostate cancer treatment from a community pharmacy lifestyle intervention.MethodsThe 3-month lifestyle intervention was delivered to 116 men in nine community pharmacies in the UK. Patient Activation Measure (PAM) was assessed at baseline, 3 and 6 months. Prostate cancer-related function and quality of life were assessed using the European Prostate Cancer Index Composite (EPIC-26) and EuroQOL 5-dimension 5-level (EQ5D-5L) questionnaires at baseline and 6 months. Lifestyle assessments included Mediterranean Diet Adherence Screener (MEDAS) at baseline, 3 and 6 months and Godin Leisure Time Exercise Questionnaire (GLTEQ) at baseline and 3 months.ResultsPAM score increased from 62 [95% CI 59–65] at baseline to 66 [64–69] after the intervention (p = 0.001) and remained higher at 6 months (p = 0.008). Scores for all the EPIC-26 domains (urinary, bowel and hormonal) were high at both assessments, indicating good function (between 74 [70–78] and 89 [86–91]), except sexual domain, where scores were much lower (21 [17–25] at baseline, increasing to 24 [20–28] at 6 months (p = 0.012)). In EQ5D-5L, 3% of men [1–9] reported self-care problems, while 50% [41–60] reported pain and discomfort, and no significant changes over time. Men who received androgen deprivation therapy, compared with those who did not, reported higher (better) urinary incontinence scores (p < 0.001), but lower (worse) scores in the urinary irritative/obstructive (p = 0.003), bowel (p < 0.001) and hormonal (p < 0.001) domains. Poor sexual function was common across all age groups irrespective of prostate cancer treatment.ConclusionsThe intervention led to significant improvements in patient activation, exercise and diet. Community pharmacy could deliver effective services to address sexual dysfunction, pain and discomfort which are common after prostate cancer.

Tobacco smoking and nicotine dependence among patients with respiratory diseases in Vietnam: Status and correlated factors

IntroductionUnderstanding nicotine dependence can support clinicians in enhancing the effectiveness of treatments for respiratory patients. Our research aimed to assess the severity of nicotine dependence among patients with respiratory diseases in Vietnam and accordingly suggest potential interventions for tobacco cessation. MethodsA cross-sectional study was conducted at the Respiratory center of Bach Mai Hospital, Hanoi, for two months of 2016 (October and November). A total of 508 respondents participated in the study Data on socio-economic characteristics and smoking patterns were collected. The Euroqol-5 dimensions-5 levels (EQ-5D-5L) and Fagerström test for nicotine dependence (FTND) were used to evaluate patient's quality of life and the nicotine dependence level, respectively. Kruskal-Wallis and Chi-square tests were used to assess the differences between variables. We applied the multivariate logistic regression and Tobit regression to categorize the association between nicotine dependence level and other factors. ResultsA total of 508 patients enrolled in our study. Former smokers and current smokers accounted for 8.1% and 38.6% of the sample, respectively. Current smokers were more likely to be male, work as free lancers, and report anxiety/depression. Higher level of nicotine dependence among current smokers was associated with the employment status of the patient. The mean number of cigarettes per day was 15.7 (SD = 11.1). The mean score of the FTND was 5.1 (SD = 2.0). Freelancers were more likely to be a current smoker (OR = 2.65, 95% CI = 2.21; 5.79). People who experienced anxiety/depression had a higher likelihood of smoking (OR = 2.21, 95% CI = 1.04; 4.72). ConclusionsCurrent smokers demonstrated a moderate level of nicotine dependence, which predict a difficult quitting and suggest the development of specialized programs to support smoking cessation counseling. Furthermore, the capabilities of physicians in supporting and counseling patients in quitting smoking should be strengthened.

Prospective observational study to examine health-related quality of life and develop models to predict long-term patient-reported outcomes 6 months after hospital discharge with blunt thoracic injuries

ObjectiveThis study aimed to examine the long-term outcomes and health-related quality of life in patients with blunt thoracic injuries over 6 months from hospital discharge and develop models to predict...

Preservation of quality of life in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial)

AimsIn HER2CLIMB, tucatinib significantly improved progression-free and overall survival in patients with human epidermal growth factor receptor 2–positive (HER2+) metastatic breast cancer. We evaluated the impact of tucatinib on health-related quality of life (HR-QoL) in HER2CLIMB. MethodsPatients were randomised 2:1 to tucatinib or placebo combined with trastuzumab and capecitabine. Starting with protocol version 7, the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS) were administered at day 1 of cycle 1, every two cycles during cycles 3–9, every three cycles during cycle 12 and thereafter and at each patient's 30-day follow-up visit. ResultsAmong 364 patients eligible for HR-QoL assessment, 331 (91%) completed ≥1 assessment. EQ-VAS scores were similar for both arms at baseline and maintained throughout treatment. EQ-5D-5L scores were similar between the treatment arms, stable throughout therapy and worsened after discontinuing treatment. Risk of meaningful deterioration (≥7 points) on EQ-VAS was reduced 19% in the tucatinib vs. placebo arm (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.55, 1.18); the median (95% CI) time to deterioration was not reached in the tucatinib arm and was 5.8 months (4.3, -) in the placebo arm. Among patients with brain metastases (n = 164), risk of meaningful deterioration on EQ-VAS was reduced 49% in the tucatinib arm (HR: 0.51; 95% CI: 0.28, 0.93); the median (95% CI) time to deterioration was not reached in the tucatinib arm and was 5.5 months (4.2, -) in the placebo arm. ConclusionsHR-QoL was preserved for patients with HER2+ metastatic breast cancer who were treated with tucatinib added to trastuzumab and capecitabine and maintained longer with tucatinib therapy than without it among those with brain metastases. Clinical Trial RegistrationNCT02614794

The effect of emicizumab prophylaxis on long-term, self-reported physical health in persons with haemophilia A without factor VIII inhibitors in the HAVEN 3 and HAVEN 4 studies.

IntroductionSevere haemophilia A (HA) has a major impact on health‐related quality of life (HRQoL).AimAssess the impact of emicizumab on HRQoL in persons with severe HA (PwHA) without factor VIII (FVIII) inhibitors in the phase 3 HAVEN 3 and 4 studies.MethodsThis pooled analysis examines the HRQoL of PwHA aged ≥ 18 years treated with emicizumab prophylaxis via Haemophilia‐Specific Quality of Life Questionnaire for Adults (Haem‐A‐QoL) and EuroQoL 5‐Dimensions 5‐levels (EQ‐5D‐5L). In particular, changes from baseline in Haem‐A‐QoL ‘Physical Health’ (PH) domain and ‘Total Score’ (TS) are evaluated.ResultsAmong 176 evaluable participants, 96 (55%) had received prior episodic treatment and 80 (45%) prophylaxis; 70% had ≥ 1 target joint and 51% had experienced ≥ 9 bleeds in the previous 24 weeks. Mean Haem‐A‐QoL PH and TS improved after emicizumab initiation. Mean (standard deviation) –12.0 (21.26)‐ and –8.6 (12.57)‐point improvements were observed in PH and TS from baseline to Week 73; Week 73 scores were 27.9 (24.54) and 22.0 (14.38), respectively. Fifty‐four percent of participants reported a clinically meaningful improvement in PH scores (≥ 10 points) by Week 73. Subgroups with poorer HRQoL prior to starting emicizumab (i.e. receiving episodic treatment, ≥ 9 bleeds, target joints) had the greatest improvements in PH scores, and corresponding reductions in missed workdays; change was not detected among those previously taking prophylaxis. No change over time was detected by the EQ‐5D‐5L questionnaire.ConclusionsEmicizumab prophylaxis in PwHA without FVIII inhibitors resulted in persistent and meaningful improvements in Haem‐A‐QoL PH and less work disruption than previous treatment.

Bullying experience in urban adolescents: Prevalence and correlations with health-related quality of life and psychological issues.

This study examined the 3-month rate of bullying experience, associated factors, and measure the relationships between bullying experience with health-related quality of life and different mental disorders among secondary school students. We performed a cross-sectional study in four secondary schools in Hanoi, Vietnam. Bullying experience was evaluated by using questions about eighteen specific-bullying behaviors. EuroQol-5 dimensions-5 levels (EQ-5D-5L) and Depression, Anxiety, and Stress Scale– 21 items (DASS-21) were used to measure health-related quality of life (HRQOL) and mental health of participants, respectively. Among 712 secondary school students, the 3-month prevalence of physical, social aggression, verbal, and sexual bullying experience were 8.4%; 31.2%; 11.9%, and 2.7%, respectively. Being bullied were negatively associated with levels of classmates and family support, as well as levels of school security. Being overweight or obese was related to a higher likelihood of suffering social aggression compared to normal BMI. Being bullied was significantly associated with the decrement of HRQOL, and the increased risk of depression, anxiety, and stress among adolescents. Findings of this study suggested that holistic approaches involving family, peers, and schools, along with enhancing school security, are potential approaches to reduce the impact of bullying on adolescents’ life and well-being.

Fear of Falling, Recurrence of Falls, and Quality of Life in Patients with a Low Energy Fracture-Part II of an Observational Study.

Background and objective: Falls in elderly cause injury, mortality, and loss of independence, making Fear of Falling (FoF) a common health problem. FoF relates to activity restriction and increased fall risk. A voluntary intervention including fall risk assessment and prevention strategies was implemented to reduce falls in elderly patients with low energy fractures (LEF). The primary purpose of this study was to evaluate FoF and the number of subsequent falls in trauma patients one year after a LEF. The secondary aim was to examine how FoF affects patients’ lives in terms of Quality of Life (QoL), mobility, and activity levels. Finally, participation in the voluntary fall prevention program (FPP) was evaluated. Materials and Methods: Observational cohort study in one Swiss trauma center. LEF patients, treated between 2012 and 2015, were analyzed one year after injury. Primary outcomes were Falls-Efficacy Score-International (FES-I) and number of subsequent falls. Secondary outcomes were EuroQoL-5-Dimensions-3-Levels (EQ5D-3L), mobility, activity levels, and participation in the FPP. Subgroup analysis was performed for different age categories. Results: 411 patients were included for analysis. Mean age was 72 ± 9.3, mean FES-I was 21.1 ± 7.7. Forty percent experienced FoF. A significant negative correlation between FoF and QoL (R = 0.64; p < 0.001) was found. High FoF correlated with lower activity levels (R= −0.288; p < 0.001). Six percent visited the FPP. Conclusions: At follow-up, 40% suffered from FoF which seems to negatively affect patients’ QoL. Nevertheless, participation in the FPP was low. Simply informing patients about their susceptibility to falls and recommending participation in FPPs seems insufficient to motivate and recruit patients into FPPs. We suggest implementing repeated fall risk- and FoF screenings as standard procedures in the follow-up of LEF, especially in patients aged over 75 years.

Do Generic Preference-Based Measures Accurately Capture Areas of Health-Related Quality of Life Important to Individuals with Amyotrophic Lateral Sclerosis: A Content Validation Study.

ObjectiveThe objectives of this study were to 1) assess the content validity of generic preference-based measures (GPBMs), and (2) examine the convergent validity of the EuroQol 5 Dimension 5 Level (EQ-5D-5L), against the Patient Generated Index (PGI) in Amyotrophic Lateral Sclerosis (ALS).MethodsParticipants were recruited from 3 clinical sites across Canada. The PGI, EQ-5D-5L and Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) were administered through an online or hardcopy survey and scores compared for convergent validation. Domains nominated by participants as important to their health-related quality of life were generated using the PGI, classified using the International Classification of Functioning, Disability and Health (ICF) and mapped onto GPBMs to determine content coverage.ResultsFifty-two participants (N=28 female; 61.3 ± 11.6 mean age ± standard deviation (SD); 3.5 ± 2.9 mean ± SD years since diagnosis) completed this study. The top three ICF domains identified by participants were recreation and leisure, lower limb mobility, and interpersonal relationships. The Quality of Well-Being Self-Administered (QWB-SA) scale had the highest content coverage (87%) and the Health Utilities Index 3 (HUI3) had the lowest (33%). Two domains were covered by all GPBMs and no GPBM included all domains identified as important by participants. A moderate correlation coefficient of 0.52 between the PGI and EQ-5D-5L was found.ConclusionThe majority of GPBMs covered only approximately half of the domains important to individuals with ALS suggesting the need for an ALS specific preference-based measure to better reflect the health-related quality of life of this population.

Wait times, resource use and health-related quality of life across the continuum of care for patients referred for total knee replacement surgery.

Background:The escalating socioeconomic burden of knee osteoarthritis (OA) underscores the need for innovative strategies to reduce wait times for total knee arthroplasty (TKA). The purpose of this study was to evaluate resource use, costs and health-related quality of life (HRQoL) across the continuum of care for patients with knee OA.Methods:This was a prospective study of 383 patients recruited from a high-volume teaching hospital at different stages of care (referral, consultation and presurgery). Outcomes included health care resource use; costs captured from the health care payer, private sector and societal perspectives; HRQoL measured using the Western Ontario and McMaster Universities Osteoarthritis Index, the 12-Item Short Form Health Survey, and EuroQoL 5-Dimension 5-Level tool; wait times; and the proportion of referrals deemed suitable candidates for surgery.Results:The most commonly used conservative treatments were pharmacotherapy, exercise and lifestyle modification. Forty percent of patients referred for TKA were deemed not to be suitable candidates for surgery. The greatest proportion of costs was borne by the patient or private insurer; a small proportion was borne by the public payer. Across all stages of care, more than 60% of the total costs was attributed to productivity losses. HRQoL remained relatively stable throughout the waiting period (mean wait time from referral to TKA 13.2 mo) but improved postoperatively.Conclusion:The suboptimal primary care management of knee OA calls for the development of innovative models of care. This study may provide valuable guidance on the design and implementation of a new online educational platform to improve referral efficiency and expedite wait times for TKA.

P301 Ustekinumab improves health-related quality of life in patients with moderate-to-severe Crohn’s disease: results up to Week 48 of the STARDUST trial

Abstract Background A treat-to-target (T2T) strategy may optimize inflammatory bowel disease management. The STARDUST trial compared a T2T maintenance strategy against standard of care (SoC) in Crohn’s disease (CD) patients treated with ustekinumab (UST). The primary endpoint, safety, and efficacy data of STARDUST have been published previously.1 Here we present results for health-related quality of life (HRQoL) measures and impact of UST on work and activities at Week (W)48 of UST maintenance, comparing T2T and SoC. Methods Adult patients with moderate–severely active CD received iv, weight-based UST ~6 mg/kg at W0 (baseline [BL]); then SC UST 90 mg at W8. At W16, CD activity index (CDAI) 70 responders were randomized (1:1) to either T2T (maintenance dosing, q12w or q8w, assigned based on endoscopic activity and further dose escalations up to q4w if clinical and biomarker-directed targets were not met) or SoC (maintenance based on EU SmPC; q12w or q8w based on clinical judgement). In this analysis we assessed changes from BL in the following HRQoL measures at W48: Inflammatory Bowel Disease Questionnaire (IBDQ), EuroQoL 5 Dimension 5 Level (EQ-5D-5L), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) tools, and Hospital Anxiety and Depression Scale – anxiety and depression subscales (HADS-A and -D) alongside the Work Productivity and Activity Impairment (WPAI) questionnaire; time lost from work was also recorded. Percentage of patients with IBDQ response (16 point improvement from BL) and remission (IBDQ score ≥170) at W48 were also analysed. Results Of 500 patients enrolled, 441 were randomized to T2T (n=220) or SoC (n=221); 79.1% and 87.3%, respectively, completed W48. At W48, the percentage of patients in T2T and SoC arms with IBDQ response (58.2% and 67.0%, respectively) and remission (45.0% and 53.4%, respectively) were similar (both p=ns). Similar changes from BL at W48 in IBDQ, EQ-5D-5L (visual analogue scale and index score), FACIT-F, HADS-A and -D and WPAI were noted in both treatment arms (Table 1). WPAI 7-Point Improvement from BL per domain at W48 are presented in Table 2. During the last 4 weeks preceding the visit at W48, patients in T2T and SoC arms on average lost 1.7 and 2.2 fewer days from work due to CD, respectively, compared to BL (p=ns). At W48, 62.3% and 72.3% were in employment in T2T and SoC arms, respectively (p=ns), compared to 61.8% and 63.5%, respectively at BL. Conclusion UST treatment improved HRQoL and work productivity and helped decrease time lost from work in patients with moderate-to-severe CD, regardless of T2T or SoC strategy. Improvements were generally maintained up to W48. Reference

Quality of life and health status of hospitalized adults with congenital heart disease in Vietnam: a cross-sectional study

BackgroundLittle is known about the quality of life (QOL) and health status of adults with congenital heart disease (CHD) in developing countries. Therefore, this study aimed to describe the QOL and health status of hospitalized adults with CHD in Vietnam and investigate the association between QOL and their biological-social characteristics.MethodsA cross-sectional study was conducted with 109 adults with CHD, hospitalized in the Vietnam National Heart Institute, between June and December 2019. Validated instruments to assess QOL and health status describing patient-reported outcomes were used, including the EuroQOL-5 Dimensions-5 Level, Satisfaction with Life Scale, and Hospital Anxiety and Depression Scale.ResultsThe mean scores on the EuroQOL-descriptive system (EQ-DS) and EuroQOL visual analogue scale (EQ-VAS) were 0.792 (SD = 0.122, 95% confidence interval [CI] 0.769–0.815) and 66.3 (SD = 12.5, 95% CI 63.9–68.7), respectively. A total of 9.2% (n = 9) patients experienced life dissatisfaction. The prevalence of anxiety and depression were 18.7% (n = 20) and 11% (n = 12), respectively. Scores of QOL in patients aged > 30 years were lower than in those aged ≤ 30 years. Stratified multivariate logistic regression revealed that poor QOL related to being unemployed/unstable employment (OR 4.43, 95% CI 1.71–11.47, p = 0.002), life dissatisfaction associated with unmarried status (OR 4.63, 95% CI 1.2–17.86, p = 0.026), anxiety regarding unemployment/unstable employment (OR 3.88, 95% CI 1.27–11.84, p = 0.017) and complex CHD/PAH (OR 4.84, 95% CI 1.33–17.54, p = 0.016), and depression regarding unemployment/unstable employment (OR 4.63, 95% CI 1.22–17.59, p = 0.003).ConclusionsReduced QOL and elevated psychological problems were common experiences among hospitalized adults with CHD in Vietnam. Biological-social characteristics such as unmarried status, unemployment/unstable employment, and complex CHD/PAH related to poor QOL, life dissatisfaction, anxiety, and depression.

Translation and adaptation of the German version of the Veterans Rand\u201436/12 Item Health Survey

BackgroundThe translated and culturally adapted German version of the Veterans Rand 36 Items Health Survey (VR-36), and its short form, the VR-12 counterpart, were validated in a German sample of orthopedic (n = 399) and psychosomatic (n = 292) inpatient rehabilitation patients.MethodsThe instruments were analyzed regarding their acceptance, distributional properties, validity, responsiveness and ability to discriminate between groups by age, sex and clinically specific groups. Eligible study participants completed the VR-36 (n = 169) and the VR-12 (n = 177). They also completed validated patient-reported outcome measures (PROs) including the Euroqol-5 Dimensions 5 Level (EQ-5D-5L); Depression, Anxiety and Stress Scale (DASS); Hannover Functional Abilities Questionnaire (HFAQ); and CDC Healthy Days. The VR-12 and the VR-36 were compared to the reference instruments MOS Short Form-12 Items Health Survey (SF-12) version 1.0 and MOS Short Form-36 Items Health Survey (SF-36) version 1.0, using percent of completed items, distributional properties, correlation patterns, distribution measures of known groups validity, and effect size measures.ResultsItem non-response varied between 1.8%/1.1% (SFVR-36/RESF-36) and 6.5%/8.6% (GHVR-36/GHSF-36). PCS was normally distributed (Kolmogorov–Smirnov tests: p > 0.05) with means, standard deviations and ranges very similar between SF-36 (37.5 ± 11.7 [13.8–66.1]) and VR-36 (38.5 ± 10.1 [11.7–67.8]), SF-12 (36.9 ± 10.9 [15.5–61.6]) and VR-12 (36.2 ± 11.5 [12.7–59.3]). MCS was not normally distributed with slightly differing means and ranges between the instruments (MCSVR-36: 36.2 ± 14.2 [12.9–66.6], MCSSF-36: 39.0 ± 15.6 [2.0–73.2], MCSVR-12: 37.2 ± 13.8 [8.4–70.2], MCSSF-12: 39.0 ± 12.3 [17.6–65.4]). Construct validity was established by comparing correlation patterns of the MCSVR and PCSVR with measures of physical and mental health. For both PCSVR and MCSVR there were moderate (≥ 0.3) to high (≥ 0.5) correlations with convergent (PCSVR: 0.55–0.76, MCSVR: 0.60–0.78) and small correlations (< 0.1) with divergent (PCSVR: < 0.12, MCSVR: < 0.16) self-report measures. Known-groups validity was demonstrated for both VR-12 and VR-36 (MCS and PCS) via comparisons of distribution parameters with significant higher mean PCS and MCS scores in both VR instruments found in younger patients with fewer sick days in the last year and a shorter duration of rehabilitation.ConclusionsThe psychometric analysis confirmed that the German VR is a valid and reliable instrument for use in orthopedic and psychosomatic rehabilitation. Yet further research is needed to evaluate its usefulness in other populations.

Estimating Utility Values for Health States of DFU Patients Using EQ-5D-5L and cTTO.

Health-state utility values of diabetic foot ulcer (DFU) patients are necessary for clinical praxis and economic modeling. The purpose of this study was to estimate utility values in DFU patients using the EuroQol-5-dimension-5-level (EQ-5D-5L) and composite time trade-off (cTTO). The EQ-5D-5L and cTTO were used for estimating utility values. Data were collected from 228 patients referred to the largest governmental diabetes center in the South of Iran, Yazd province. When appropriate, independent sample t-test or analysis of variance test was used to test the difference in the utility values in each of the demographic and clinical characteristics of the patients. Finally, the BetaMix was used to identify predictors of the utility values. The means of EQ-5D-5L and cTTO values were 0.55(SD 0.21) and 0.67(SD 0.23), respectively. Anxiety and pain were the most common problems reported by the patients. The difference between the mean EQ-5D-5L values was significant for age, grade of ulcer, number of comorbidities, and having complications. In addition, variables of gender, age, grade of ulcer, and having complications were significant predictors of the EQ-5D-5L. The difference between the mean cTTO values was significant for age, employment status, grade of ulcer, number of comorbidities, and having complications. Moreover, variables of gender, age, grade of ulcer, number of comorbidities, and developing complications were significant predictors of cTTO. The current study provided estimates of utility values for DFU patients for clinical praxis and economic modeling. These estimates, similar to utilities reported in other studies, were low. Identifying strategies to decrease anxiety/depression and pain in patients is important to improve the utility values.

Effect of lisocabtagene maraleucel on HRQoL and symptom severity in relapsed/refractory large B-cell lymphoma

AbstractCD19-directed chimeric antigen receptor (CAR) T-cell therapy has shown efficacy as a third-line or later treatment in patients with relapsed/refractory large B-cell lymphoma (LBCL). Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, we evaluated the impact of CAR T-cell treatment with lisocabtagene maraleucel (liso-cel) on health-related quality of life (HRQoL) and symptoms in patients with relapsed/refractory LBCL in the ongoing, open-label, nonrandomized TRANSCEND NHL 001 trial. Clinically meaningful improvement was observed in EORTC QLQ-C30 scores for global health status/QoL, based on a minimally important difference of 10 points at 2 to 18 months after liso-cel infusion. There were no clinically meaningful changes in physical functioning and pain, whereas clinically meaningful improvements were observed in fatigue at 2, 12, and 18 months. The proportion of patients with clinically meaningful improvement in global health status/QoL was generally higher for treatment responders than for nonresponders. A trend toward decreased mean EQ-5D-5L index scores was observed at 1 month after liso-cel infusion, followed by subsequent increases through 18 months. Mean EQ-5D-5L visual analog scale scores increased from 2 through 18 months. In summary, patients with relapsed/refractory LBCL treated with liso-cel had early, sustained, and clinically meaningful improvements in HRQoL and symptoms that correlated with antitumor activity. This study was registered at www.clinicaltrials.gov as #NCT02631044.

Patient-reported outcomes from STARTRK-2: a global phase II basket study of entrectinib for ROS1 fusion-positive non-small-cell lung cancer and NTRK fusion-positive solid tumours

BackgroundPatient-reported outcomes (PROs) are increasingly relevant endpoints in clinical trials, contributing to our understanding of risk–benefit profiles, in addition to efficacy and safety data. We investigated the impact of entrectinib on patient-reported symptoms, functioning, and health-related quality of life.Patients and methodsSTARTRK-2 is a phase II basket study in patients with locally advanced/metastatic neurotrophic receptor tyrosine kinase 1/2/3 (NTRK1/2/3) and ROS proto-oncogene 1 (ROS1) fusion-positive solid tumours. PROs (prespecified secondary endpoint) were evaluated using the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (QLQ-C30), lung cancer module (QLQ-LC13), and colorectal cancer module (QLQ-CR29), and the EuroQoL 5-Dimension 3-Level instruments, completed before cycle 1 day 1 and each subsequent 4-week cycle of entrectinib dosing, and the end of treatment. Adverse events and treatment-related symptoms were assessed in the safety analysis (SA)-PRO population. Tumour-related symptoms, functioning, and global health status were assessed in the efficacy analysis (EA)-PRO population. Data cut-offs: 31 October 2018 NTRK cohort; 01 May 2019 ROS1 cohort.ResultsSA-PRO populations comprised patients with NTRK fusion-positive solid tumours (N = 88) or ROS1 fusion-positive non-small-cell lung cancer (N = 180) who received one or more doses of entrectinib, completed PRO questionnaires on cycle 1 day 1 and answered one or more questions on-study. EA-PRO populations (N = 71) and (N = 145), respectively, comprised SA-PRO patients with measurable baseline disease. Moderate-to-high baseline global health status scores were maintained in EA-PRO populations during treatment. Role and physical functioning scores were moderate-to-high at baseline, with trends towards clinical improvement during treatment. Both cohorts reported low-to-moderate symptom burden at baseline, which was maintained or trended towards clinically meaningful improvement. Symptoms commonly associated with cancer treatment (e.g. nausea, fatigue) remained stable or improved during treatment. All SA-PRO patients experienced one or more adverse events, most frequently constipation or diarrhoea.ConclusionsPRO findings were consistent with the favourable safety profile of entrectinib, and further reinforce the positive benefit–risk profile of this treatment, indicating minimal overall treatment burden.

A Pilot Study on the Quality of Sexual Life of Patients Receiving Home Palliative Care in Poland

Background: Quality of life, physical, psychic, and social functioning assessments in patients suffering from chronic, progressive, and incurable diseases are one of the most significant aims of the palliative care home teams. Sexuality and intimacy can be one of the most important elements of a person’s life, even at the end of it. Unfortunately, there is very little interest in this topic among medical staff of palliative care units. The objective of the study: The aim of this study was to assess the health status, the quality of life, the quality of sexual life, and the recognition and resolution of sexual problems by the palliative care team in adult patients in the advanced stage of terminal illness, who were receiving home palliative care. Research methods: The study involved 342 adult patients in the advanced stage of incurable, progressive disease, covered by home palliative care in 15 facilities in Poland. A generic EuroQoL 5-Dimension 3-Level health and quality of life assessment questionnaire and a questionnaire developed by the researchers, including questions about sexual problems, were used in this prospective study. Results: The presented results are the part of the more extensive study. The assessment of health status and quality of life of the study patients showed that the evaluation was the lowest for performing ordinary daily activities. The quality of sexual life after diagnosis in more than half of the study patients has worsened. Almost half of the respondents felt that the palliative care team did not recognize or address their sexual concerns. Patients indicated nurses and physicians as the members of the palliative care team most helpful in identifying and addressing sexual concerns. Conclusions: Members of the palliative care team should receive training in communication with patients concerning their sexual life, their needs and expectations and have knowledge about options for obtaining specialized sexological care. It is necessary to prepare and validate simple tools that will facilitate the initiation of appropriate communication between patients and members of the medical staff. It will be important to conduct more detailed and targeted research on sexuality and intimacy in the Polish palliative care patient population.

Health-related Quality of Life Outcomes of Adalimumab for Patients With Rheumatoid Arthritis in Korea.

Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disorder that impairs patients' overall health-related quality of life (HRQOL) In this study, we evaluated the effect of adalimumab in Korean patients with active RA on HRQOL. Patients included in the study had moderate to severe active RA that did not respond to conventional drugs with a Disease Activity Score of 28 joints >32 and were biologics-naïve All patients received adalimumab 40 mg subcutaneously every other week and were followed for 24 weeks The primary endpoint was the change in baseline Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 24 Secondary endpoints were changes in the EuroQol 5-dimension 3-Level (EQ-5D-3L) baseline score and Short Form 36-Item Health Survey (SF-36) domain scores at weeks 12 and 24 and change in baseline HAQ-DI score at week 12. In total, 91 Korean patients were included Ninety-three percent of patients were in high disease activity with a baseline mean DAS28 value of 61 within all patients The mean change from baseline in HAQ-DI scores were -046 at week 12 and∼067 at week 24 (p<00001) Additionally, EQ-5D-3L score at weeks 12 and 24 had significantly improved (p<00001) compared to baseline SF-36 at weeks 12 and 24 had significantly improved (p<00001, p=00001) compared to baseline. Treatment with adalimumab resulted in significant improvement in HAQ-DI, EQ-5D-3L, and SF-36 scores at 12 and 24 weeks in Korean RA patient.

Health-related quality of life in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer treated with first-line pembrolizumab versus chemotherapy (KEYNOTE-177): an open-label, randomised, phase 3 trial

In the KEYNOTE-177 study, pembrolizumab monotherapy provided statistically significant and clinically meaningful improvements in progression-free survival versus chemotherapy as first-line treatment in patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. To further support the efficacy and safety findings of the KEYNOTE-177 study, results of the health-related quality of life (HRQOL) analyses are reported here. KEYNOTE-177 is an open-label, randomised, phase 3 trial being done at 192 cancer centres in 23 countries, in patients aged 18 years and older with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and who had not received previous systemic therapy for metastatic disease. Eligible patients were randomly assigned (1:1) centrally by use of interactive voice response or integrated web response technology to receive pembrolizumab 200 mg intravenously every 3 weeks or investigator's choice chemotherapy (mFOLFOX6 [leucovorin, fluorouracil, and oxaliplatin] or FOLFIRI [leucovorin, fluorouracil, and irinotecan] intravenously every 2 weeks with or without intravenous bevacizumab or cetuximab). Patients and investigators were not masked to treatment assignment. The primary endpoints were progression-free survival (previously reported) and overall survival (data to be reported at the time of the final analysis). HRQOL outcomes were evaluated as prespecified exploratory endpoints. The analysis population comprised all randomly assigned patients who received at least one dose of study treatment and completed at least one HRQOL assessment. HRQOL outcomes were mean change from baseline to prespecified week 18 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scale and item scores, and in the EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) visual analogue scale and health utility scores; the proportion of patients with improved, stable, or deteriorated scores from baseline to prespecified week 18 in EORTC QLQ-C30 scales and items; and time to deterioration in EORTC QLQ-C30 global health status/quality of life (GHS/QOL), physical functioning, social functioning, and fatigue scores and EORTC QLQ-CR29 urinary incontinence scores. The threshold for a small and clinically meaningful mean difference in EORTC QLQ-C30 score was 5-8 points. This study is registered with ClinicalTrials.gov, NCT02563002 and is ongoing; recruitment is closed. Between Feb 11, 2016, and Feb 19, 2018, 307 patients were enrolled and randomly assigned to receive pembrolizumab (n=153) or chemotherapy (n=154). The HRQOL analysis population comprised 294 patients (152 receiving pembrolizumab and 142 receiving chemotherapy). As of Feb 19, 2020, median time from randomisation to data cutoff was 32·4 months (IQR 27·7-37·8). Least squares mean (LSM) change from baseline to prespecified week 18 showed a clinically meaningful improvement in EORTC QLQ-C30 GHS/QOL scores with pembrolizumab versus chemotherapy (between-group LSM difference 8·96 [95% CI 4·24-13·69]; two-sided nominal p=0·0002). Median time to deterioration was longer with pembrolizumab versus chemotherapy for GHS/QOL (hazard ratio 0·61 [95% CI 0·38-0·98]; one-sided nominal p=0·019), physical functioning (0·50 [95% CI 0·32-0·81]; one-sided nominal p=0·0016), social functioning (0·53 [95% CI 0·32-0·87]; one-sided nominal p=0·0050), and fatigue scores (0·48 [95% CI 0·33-0·69]; one-sided nominal p<0·0001). Pembrolizumab monotherapy led to clinically meaningful improvements in HRQOL compared with chemotherapy in patients with previously untreated microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. These data, along with the previously reported clinical benefits, support pembrolizumab as a first-line treatment option for this population. Merck Sharp & Dohme, a subsidiary of Merck & Co, Kenilworth, NJ, USA.