EuroQol-5 Dimensions-5 Levels Research Articles

PDB69 - Valuing Health-Related Quality of Life for Inpatients with Diabetes-Related Complications In China

Disease burden of type 2 diabetes (T2DM) is escalating. Quite a few studies have evaluated the health-related quality of life (HRQOL) of overall T2DM patients, but few focused on that of inpatients with specific diabetes-related complications. Reliable estimates of the impact of complications on HRQOL are important to understand the event burden and serve for economic evaluation. This study aims to estimate the utility-based HRQOL of inpatients with diabetes-related complications in China, and explore the influencing factors. This is a cross-sectional study conducted in a tertiary hospital in Shandong, China. T2DM patients (≥18 years) hospitalized during January, April and May 2017 for their complications, including ischemic heart disease (IHD), myocardial infarction (MI), congestive heart failure (CHF), stroke, impaired vision (IV), end-stage renal disease (ESRD), ulcer or amputation were recruited. The EuroQOL 5-dimensions 3-level(EQ-5D-3L) instrument was administered to these inpatients through face-to-face interviews. Clinical and sociodemographic data were collected from the survey. One-way analysis of variance and multiple linear regression analysis were performed. 802 T2DM inpatients (female 43%) provided data. Mean age was 62.67(SE:0.4) years. The most prevalent problems reported were impairments in Usual Activities. Mean EQ-5D index score of the total sample was 0.562(SE:0.007), with EQ-VAS score of 61.72(SE:0.606). HRQOL varied between complications with significant differences. Mean EQ-5D index scores were: IHD 0.620(0.012), MI 0.434(0.020), CHF 0.471(0.019), stroke 0.472(0.018), IV 0.714(0.012), ESRD 0.693(0.012), ulcer 0.431(0.029), and amputation 0.395(0.027). Mean EQ-VAS scores were: IHD 65.26(1.120), MI 58.84(1.722), CHF 56.70(1.800), stroke 58.59(1.565), IV 66.18(1.418), ESRD 63.57(1.568), ulcer 60.86(2.589), and amputation 55.00(5.426). Complication, exercise, confidence in treatment, worry about the disease were reported to influence the HRQOL. HRQOL of T2DM inpatients was largely impaired. Our estimates demonstrate the magnitude of the impact of eight complications on utility-based measures of HRQOL, which may be used for public health and cost-effectiveness modeling.

Development and predictive validity of the cirrhosis-associated ascites symptom scale: A cohort study of 103 patients.

AIMTo develop a scale of domains associated with the health-related quality-of-life (HRQOL) in patients with cirrhosis-related ascites.METHODSWe initially undertook literature searches and a qualitative study in order to design a cirrhosis-associated ascites symptom (CAS) scale describing symptoms with a potential detrimental impact on health related quality of life (HRQL) (the higher the score, the worse the symptoms). Discriminatory validity was assessed in a validation cohort including cirrhotic patients with (1) tense/severe; (2) moderate/mild; or (3) no ascites (controls). Patients also completed chronic liver disease questionnaire (CLDQ) and the EuroQoL 5-Dimensions 5-Level (EQ-5D-5L) questionnaire evaluating HRQL. The relation between scale scores was analysed using Spearman correlations.RESULTSThe final CAS scale included 14 items. The equivalent reliability was high (Chronbach’s alpha 0.88). The validation cohort included 103 patients (72% men, mean age 62.4 years). The mean scores for each question in the CAS scale were higher for patients with severe/tense ascites than for mild/moderate ascites and controls. Compared with controls (mean = 9.9 points), the total CAS scale score was higher for severe/tense ascites (mean = 23.8 points) as well as moderate/mild ascites (mean = 18.6 points) (P < 0.001 both groups). We found a strong correlation between the total CAS and CLDQ score (rho = 0.82, P < 0.001) and a moderate correlation between the CAS and the EQ-5D-5L score (0.67, P < 0.001).CONCLUSIONThe CAS is a valid tool, which reflects HRQOL in patients with ascites.

Prospective utility study of patients with multiple cardiovascular events

Objectives: The effects of acute coronary syndrome (ACS) events on health-related quality-of-life (HRQoL) and the time dependency of these effects are unknown. This study aimed to characterize health utilities in ACS patients to aid development of future economic models estimating the cost per quality-adjusted life-year impact of ACS events and potential treatments.Methods: Multi-center, non-interventional, longitudinal evaluation of health utility in patients experiencing ACS or stroke events. EuroQol-5 dimension 3 level (EQ-5D-3L) surveys were sent to patients (≥18 years) from three UK centers, 1 month after hospital discharge for myocardial infarction (MI), unstable angina (UA), or stroke. Patient demographics, lifestyle, and baseline utility score were collected in the first survey. Follow-up surveys were sent at 6, 12, 18, and 24 months to prospectively capture utility and subsequent health events. Two methods of patient identification were adopted—prospective, where the patient’s qualifying events occurred after the study index date, and retrospective, where the patient’s qualifying event occurred prior to the study index date. General healthy population utility values were assumed for pre-event HRQoL.Results: Between January 2011 and March 2014, 2,103 prospectively (n = 1,350)/retrospectively (n = 753) identified patients (mean age = 68.3 years; 67.9% male) responded: MI = 55.9% (n = 1,176), UA = 42.7% (n = 898), stroke = 1.4% (n = 29); 24% had type 2 diabetes. Post-event utility values were lower than general healthy population values, although significant differences in utility between subsequent 6 (n = 1,031, change = –0.002), 12 (n = 1,096, change = –0.008), 18 (n = 1,246, change = –0.007), and 24 (n = 1,277, change = –0.004) month timepoints were not detected. Through multivariate regression analyses, wheelchair use, current smoking, and secondary mental and joint health events were associated with the greatest statistically significant utility decrements.Conclusions: This study indicates that health utility decreases following a cardiovascular event and, although some improvement occurs over the subsequent 24 months, general healthy population utility is not necessarily attained.

A review of preference-based measures for the assessment of quality of life in children and adolescents with cerebral palsy.

To examine the psychometric properties and suitability for use within the context of cerebral palsy research in children and adolescents of generic preference-based outcome measures (PROMs). Nine electronic databases were searched in this systematic review. The consensus-based standards for the selection of health measurement instruments (COSMIN) checklist were used to measure the psychometric properties of the PROMs. A meta-analysis was used to pool correlation coefficients for convergent validity using the Schmidt-Hunter method. Heterogeneity was assessed using the I-squared statistic (I2). Four preference-based PROMs were identified from eight studies: Health Utilities Index-Mark 2 and 3 (HUI-2 and HUI-3, respectively), the Assessment Quality of Life-4 dimension (AQoL-4D) and the EuroQol-5 dimension 3 level (EQ-5D-3L). Only the HUI system was primarily developed for application with children/adolescents though health-state values for scoring the PROM were elicited from adults. The HUI-3 covered the most relevant constructs though it excludes important modules of health-related quality of life (HRQOL) such as activity limitations and participation restrictions. In terms of psychometric properties, evidence was presented for only five of COSMIN measurement properties: reliability (HUI3), measurement error (HUI-3), content validity (HUI-2 and HUI-3), Hypotheses testing (HUI-3 and AQoL-4D) and criterion validity (HUI-3). No papers reported on internal consistency, structural validity, cross-cultural validity or responsiveness of the preference-based measures in children and adolescents with cerebral palsy. This review highlights the dearth in studies using preference-based PROMs to measure HRQOL associated with cerebral palsy in children and adolescents. The HUI-3 demonstrated the strongest psychometric properties, though it does not cover all dimensions relevant to this population.

Quality of life in hemodialysis diabetic patients: a multicenter cross-sectional study from Palestine

BackgroundBoth diabetes and hemodialysis can seriously impair patients’ health related quality of life (HRQOL). This study seeks to obtain data which will help to address the factors associated with impaired HRQOL in hemodialysis patients with diabetes in Palestine.MethodsA cross-sectional study was performed in multiple centers in the period from November 2016 to June 2017. We utilized the Arabic version of EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) scale and EuroQol-visual analogue scale (EQ-VAS) to measure patients’ HRQOL. The study was conducted in six dialysis centers in the North of West Bank, Palestine. Descriptive and comparative statistics were used to describe clinical and socio-demographic features of patients. Multiple linear regression analysis was used to determine the association between clinical and socio-demographic factors and HRQOL score.ResultsOne hundred and forty one diabetic patients undergoing hemodialysis were enrolled in our study. Overall, 52.5% of them (74 patients) were males; the patients had a mean age of 60.32 with 52.5% of them aged below 60. The mean ± standard deviation of EQ-5D-5L index and EQ-VAS score was 0.314 ± 0.4 and 50.85±22.43, respectively. The findings of this study suggest that female patients, uneducated patients, unemployed patients, unmarried patients, and patients with more chronic diseases and comorbidities had a significant poor HRQOL scores (p values <0.05). Variables such as marital status and occupational status were significantly (p < 0.05) associated with the QOL score. More specifically, married status and employed patients positively associated with QOL score (β = 0.22; p = 0.016 and β = 0.27; p = 0.013, respectively).ConclusionsAmong diabetic patients undergoing hemodialysis, married status and being employed were associated with modestly higher scores of QOL. We recommend that healthcare providers give more attention to diabetic dialysis patients who are unemployed and unmarried, as they are at a higher risk of having impaired HRQOL.

The Patient Perspective on the Impact of Tenosynovial Giant Cell Tumors on Daily Living: Crowdsourcing Study on Physical Function and Quality of Life.

BackgroundTenosynovial giant cell tumor (TGCT) is a rare, benign lesion affecting the synovial lining of joints, bursae, and tendon sheaths. It is generally characterized as a locally aggressive and often recurring tumor. A distinction is made between localized- and diffuse-type. The impact of TGCT on daily living is currently ill-described.ObjectiveThe aim of this crowdsourcing study was to evaluate the impact of TGCT on physical function, daily activities, societal participation (work, sports, and hobbies), and overall quality of life from a patient perspective. The secondary aim was to define risk factors for deteriorated outcome in TGCT.MethodsMembers of the largest known TGCT Facebook community, PVNS is Pants!!, were invited to an e-survey, partially consisting of validated questionnaires, for 6 months. To confirm disease presence and TGCT-type, patients were requested to share histological or radiological proof of TGCT. Unpaired t tests and chi-square tests were used to compare groups with and without proof and to define risk factors for deteriorated outcome.ResultsThree hundred thirty-seven questionnaires, originating from 30 countries, were completed. Median age at diagnosis was 33 (interquartile range [IQR]=25-42) years, majority was female (79.8% [269/337]), diffuse TGCT (70.3% [237/337]), and affected lower extremities (knee 70.9% [239/337] and hip 9.5% [32/337]). In 299 lower-extremity TGCT patients (32.4% [97/299]) with disease confirmation, recurrence rate was 36% and 69.5% in localized and diffuse type, respectively. For both types, pain and swelling decreased after treatment; in contrast, stiffness and range of motion worsened. Patients were limited in their employment (localized 13% [8/61]; diffuse 11.0% [21/191]) and sport-activities (localized 58% [40/69]; diffuse 63.9% [147/230]). Compared with general US population, all patients showed lower Patient-Reported Outcomes Measurements Information System-Physical Function (PROMIS-PF), Short Form-12 (SF-12), and EuroQoL 5 Dimensions 5 Levels (EQ5D-5L) scores, considered clinically relevant, according to estimated minimal important difference (MID). Diffuse versus localized type scored almost 0.5 standard deviation lower for PROMIS-PF (P<.001) and demonstrated a utility score of 5% lower for EQ-5D-5L (P=.03). In localized TGCT, recurrent disease and ≥2 surgeries negatively influenced scores of Visual Analog Scale (VAS)-pain/stiffness, SF-12, and EQ-5D-5L (P<.05). In diffuse type, recurrence resulted in lower score for VAS, PROMIS-PF, SF-12, and EQ-5D-5L (P<.05). In both types, patients with treatment ≤1year had significantly lower SF-12.ConclusionsTGCT has a major impact on daily living in a relatively young and working population. Patients with diffuse type, recurrent disease, and ≥2 surgeries represent lowest functional and quality of life outcomes. Physicians should be aware that TGCT patients frequently continue to experience declined health-related quality of life and physical function and often remain limited in daily life, even after treatment(s).

Abstract TP276: Health-Related Quality of Life Indices for Patients with Primary Intracerebral Hemorrhage

Introduction: Assessments of health-related quality of life (QoL) are increasingly important for stroke patients; however, such data are lacking for patients with intracerebral hemorrhage (ICH). Using EuroQol-5 Dimension-5 Level (EQ5D), we describe factors associated with QoL, and explore associations between QoL and functional outcomes in ICH patients. Methods: Our study is a multisite prospective cohort aiming to examine comparative effectiveness of treating ICH patients at various levels of care across Texas. Consented patients undergo QoL assessments - including EQ5D - in-hospital and 90 days post-discharge. EQ5D health utility values (HUV) were calculated using published utility weights for US population. HUVs range from -0.11 to 1.00, with 0.00 and 1.00 representing patient-perceived QoL equivalent to death and perfect health, respectively. Median and interquartile range (IQR) are reported. Quantile regression was used to evaluate factors associated with HUVs, and we report difference in median (DIM) and 95% confidence interval (CI) for the difference. Results: Thus far 158 patients have been enrolled in the study. EQ5D HUVs were obtained from 133 patients in-hospital and 62 patients at day 90. Median in-hospital and day-90 HUVs were significantly lower for patients with higher NIHSS and ICH scores. Patients with in-hospital complications, neurosurgical procedures, and longer length of stay also had lower HUVs (Table 1). There was a significant improvement in HUVs during 90-days post-discharge (DIM: 0.37; 95% CI: 0.24-0.51), and high day-90 HUVs were associated with good functional outcome (mRS 0-3) (Figure 1, DIM: 0.65, 95% CI: 0.51-0.78, p&lt;0.001). Enrollment continues; updated analyses to be presented. Conclusion: Our results indicate a correlation between QoL, and inpatient clinical parameters and functional outcomes. Assessment of QoL may be routinely conducted in ICH studies to generate evidence for comparative effectiveness.

Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial

BackgroundPostoperative pain is a major complaint following abdominal surgery for gynecological diseases. Effective postoperative pain control after abdominal surgery is particularly important for patient recovery, mobility, and satisfaction. Acupuncture has been commonly used for pain management. However, its efficacy in postoperative pain control is inconclusive and health economic evaluation is limited.MethodsA randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following abdominal surgery of gynecological diseases. Patients who are eligible for laparotomy with a midline incision for gynecological neoplasia, including ovarian mass, uterine mass, and cervical lesions, will be recruited. Seventy-two participants will be randomly allocated to an acupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 h before operation, upon arrival to the ward and once daily for 5 days. The Pain Numerical Rating Scale (NRS) on the first 5 days during hospitalization will be the primary outcome and will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include frequency of rescue analgesic use during hospital stay, cumulative morphine consumption; quality of recovery as measured by time to recovery variables and the Quality of Recovery-9 (QoR-9); quality of life as measured by the Short Form-6 dimension (SF-6D) and EuroQol-5 Dimension-5 Level (EQ-5D-5 L). The incremental cost-effectiveness ratio of acupuncture vs sham acupuncture will be calculated.DiscussionThis study protocol provides an example of integrative medicine practice in a hospital setting for the management of postoperative pain using acupuncture treatment. The acupuncture treatment protocol, if proven to be effective, can be implemented in routine settings to play a role in postoperative pain management for patients who have undergone abdominal surgery for gynecological diseases.Trial registrationClinicalTrials.gov, ID: NCT02851186. Registered on 19 July 2016.

Medical Resource Consumption and Quality of Life in Peripheral Arterial Disease in Korea: PAD Outcomes (PADO) Research.

Background and ObjectivesWe aimed to investigate the history of medical resource consumption and quality of life (QoL) in peripheral arterial disease (PAD) patients in Korea.MethodsThis was a prospective, multi-center (23 tertiary-hospitals, division of cardiology), non-interventional study. Adult patients (age ≥20 years) suffering from PAD for the last 12-month were enrolled in the study if they met with any of following; 1) ankle-brachial index (ABI) ≤0.9, 2) lower-extremity artery stenosis on computed tomography angiography ≥50%, or 3) peak-systolic-velocity-ratio (PSVR) on ultrasound ≥2.0. Medical chart review was used to assess patient characteristics/treatment patterns while the history of medical resource consumption and QoL data were collected using a patient survey. QoL was measured using EuroQoL-5-dimensions-3-level (EQ-5D-3L) score system, and the factors associated with QoL were analyzed using multiple linear regression analysis.ResultsThis study included 1,260 patients (age: 69.8 years, male: 77.0%). The most prevalent comorbidities were hypertension (74.8%), hyperlipidemia (51.0%) and diabetes-mellitus (50.2%). The 94.1% of the patients took pharmacotherapy including aspirin (76.2%), clopidogrel (53.3%), and cilostazol (33.6%). The 12.6% of the patients were receiving smoking cessation education/pharmacotherapy. A considerable number of patients (500 patients, 40.0%) had visit history to another hospital before diagnosis/treatment at the current hospital, with visits to orthopedic units (50.4%) being the most common. At the time, 29% (or higher) of the patients were already experiencing symptoms of critical limb ischemia. Baseline EQ-5D index and EQ VAS were 0.64±0.24 and 67.49±18.29. Factors significantly associated with QoL were pharmacotherapy (B=0.05053; p=0.044) compared to no pharmacotherapy, and Fontaine stage improvement/maintain stage I (B=0.04448; p<0.001) compared to deterioration/maintain stage II–IV.ConclusionsIncrease in disease awareness for earlier diagnosis and provision of adequate pharmacotherapy is essential to reduce disease burden and improve QoL of Korean PAD patients.

Improved health-related quality of life, participation, and autonomy in patients with treatment-resistant chronic pain after an intensive social cognitive intervention with the participation of support partners.

Despite the availability of various specific treatments, most patients with chronic pain (CP) consider their pain problem as undertreated. Recently, multiple sclerosis (MS) patients who were given an intensive 3-day social cognitive treatment with the participation of support partners experienced lasting improvements in health-related quality of life (HRQoL) and self-efficacy. In this study, a similar intervention was given to treatment-resistant CP patients with stressors, relational problems with support partner, and distress, anxiety or depression. Before and 1, 3, and 6 months after the intervention, patients completed the Euro-Qol 5 Dimensions 5 Levels (EQ-5D-5L) and Impact on Participation and Autonomy (IPA) questionnaires (primary outcomes), and the Survey Of Pain Attitudes (SOPA), the Four-Dimensional Symptom Questionnaire (4DSQ) (distress, depression, anxiety, and somatization), and Visual Analog Scale for pain intensity, whereas the support partners completed the Caregiver Strain Index (CSI) questionnaire. Differences between baseline and post-treatment were tested via paired t-tests (significance level 0.05). Of the 39 patients who were included, 34 (87.2%) completed the 3-day treatment. At 1, 3, and 6 months, improvements were seen in EQ-5D-5L-Index (+40.6%; +22.4%; +31.7%), Health Today (+61.8%; +36.3%; +46.8%), Control attitude (+45.8%; not significant [NS]; +55.0%) and decreases in IPA-Problems (−14.8%; NS; −20.4%), Harm attitude (−18.9%; −15.0%; −17.7%), Distress (−17.7%; −31.8%; −37.1%), and Depression (−37.4%; −31.4%; −35.7%) scores. The CSI score had decreased by −29.0%, −21.4%, and −25.9%, respectively. In conclusion, after an intensive 3-day social cognitive intervention, treatment-resistant CP patients experienced substantial and lasting improvements in HRQoL and in problematic limitations to participation and autonomy, in association with improvements in pain attitudes, depression, and distress. To assess whether this innovative approach may be an effective treatment for this subgroup of CP patients, future randomized controlled studies are needed.

Alcohol and tobacco use among methadone maintenance patients in Vietnamese rural mountainside areas

IntroductionThe expansion of methadone maintenance treatment (MMT) program requires more data about the factors affecting the effectiveness of treatment, especially behavioral data such as smoking and alcohol use among patients. This study aimed to examine the prevalence of tobacco and alcohol consumption and identify related factors among MMT patients in the Vietnamese rural mountainside. MethodsWe interviewed 241 MMT patients in two clinics in Tuyen Quang, a mountainous province in Vietnam. Patients were asked to report the smoking status (current smoker or not), nicotine dependence (by Fagerström test for nicotine dependence - FTND) and alcohol use (by using the Alcohol Use Disorders Identification Test – AUDIT-C). EuroQol-5 dimensions-5 levels (EQ-5D-5L) and EQ-Visual analogue scale (EQ-VAS) were employed to measure health-related quality of life. Multivariate logistic and Tobit regressions were used to identify the associated factors. ResultsThe majority of respondents were current smokers (75.7%) and a low proportion were hazardous drinkers (18.3%). People receiving treatment in a rural clinic (OR=0.45; 95%CI=0.22–0.92) and had problems in usual activities (OR=0.20; 95%CI=0.06–0.70) were less likely to be smokers. Q-VAS score (Coef.=0.03; 95%CI=0.02–0.05) and having problems in mobility (Coef.=0.72; 95%CI=0.03–1.42) was found to be associated with the increase of nicotine dependence. In terms of alcohol drinking, people with other jobs were more likely to drink hazardously compared to unemployed patients (OR=2.86; 95%CI=1.20–6.82). Similarly, patients having higher duration of MMT had higher likelihood of being hazardous drinkers (OR=1.07; 95%CI=1.01–1.13). ConclusionsThis study highlights the low rate of alcohol abusers but a considerably high proportion of current smokers among MMT patients in the rural mountainside area. Alcohol and tobacco counseling programs combined with social and family support also play an essential role in alcohol and tobacco control. In addition, implementing mass community-based behavioral change campaigns to reduce drug addiction-related stigmatization should also be prioritized.

Quality of life profile of general Vietnamese population using EQ-5D-5L

BackgroundHealth-related quality of life (HRQOL) is a vital benchmark to assess the effects of health interventions and policies. Measuring HRQOL of the general population is essential to establish a reference for health outcomes evaluations. However, evidence on HRQOL of general populations in low and middle income countries is very limited. This study aimed to measure HRQOL of the Vietnamese population by using the EuroQol-5 dimensions-5 levels (EQ-5D-5L) instrument and determine its associated factors.MethodsA cross-sectional study was performed in Hanoi with 1571 residences in Hanoi, the capital city of Vietnam. EQ-5D-5L and EQ- visual analogue scale (EQ-VAS) were used to assess HRQOL. Potential covariates included socio-demographic characteristics, having acute symptoms in the last four weeks, chronic diseases in the last three months, having multiple health issues, and health service utilisation in the last twelve months. A generalized linear model was employed to identify the association between HRQOL and covariates.ResultsOverall, the mean EQ-5D utility index was 0.91 (SD = 0.15), and the mean EQ-VAS score was 87.4 (SD = 14.3). The highest proportion of respondents reporting any problems was in Usual activities (24.3%), followed by Anxiety/Depression (15.2%) and Pain/Discomfort (10.0%), while the lowest percentage was in Self-care (2.5%). Lower HRQOL composite scores were related to unemployment, lower income, higher education, living in urban areas, having chronic diseases, having multiple health issues and using health service. For any health problem self-reported by respondents, the health utility reduced by 0.02 (respiratory diseases) to 0.15 (musculoskeletal diseases).ConclusionsHealth utility of the general population and reductions for self-reported health problems in this study are useful for future population health evaluations and comparisons. It also informs the development of interventions to reduce health problems of the general population.

Nab-paclitaxel/carboplatin induction in squamous NSCLC: longitudinal quality of life while on chemotherapy.

BackgroundLongitudinal data on the impact of treatment on quality of life (QoL) in advanced non-small cell lung cancer (NSCLC) are limited. In this palliative setting, treatment that does not deteriorate QoL is key. Here we report longitudinal QoL in patients with squamous NSCLC, receiving ≤4 cycles of nab-paclitaxel/carboplatin combination chemotherapy.MethodsPatients received nab-paclitaxel 100 mg/m2 days 1, 8, 15 + carboplatin area under the curve 6 mg•min/mL day 1 (q3w) for four cycles. QoL was assessed by the Lung Cancer Symptom Scale (LCSS) and Euro-QoL-5 Dimensions-5 Levels (EQ-5D-5L) at baseline and each cycle (day 1).ResultsTwo-hundred and six lesion-response-evaluable patients completed baseline + ≥1 postbaseline QoL assessment and were QoL evaluable. LCSS average total score and symptom burden index improved from baseline throughout four cycles. In the LCSS pulmonary symptoms score, 46% of patients reported clinically meaningful improvement (≥10 mm visual analog scale) from baseline. Individual EQ-5D-5L dimensions remained stable/improved in ≥83% of patients; ≈33% reported complete resolution of baseline problems at least once during four cycles. Generally, responders (unconfirmed complete/partial response) had higher scores vs nonresponders.ConclusionIn patients with squamous NSCLC, four cycles of nab-paclitaxel/carboplatin demonstrated clinically meaningful QoL improvements, with greater benefits in responders vs nonresponders.

Health-Related Quality-Of-Life And Utility Measures Impact In A Randomized Controlled Study Of Fine Needle Aspiration Cytology (FNAC) Versus Watchful Observation In Patients With Incidental Symptomatic Thyroid Nodules

To present the impact of treatment on health-related quality-of-life (HRQOL) and health utility measures from the randomized controlled trial (ClinicalTrials.gov Identifier: NCT02398721) that investigated the FNAC versus watchful observation in patients with symptomatic benign thyroid nodules. Health utility and HRQOL were evaluated using the EuroQoL 5-dimension 5-level (EQ-5D-5L), 6-item Short Form Health Survey (SF-6D), cancer-specific Functional Assessment of Cancer Therapy-general (FACT-G) and generic 12-item Short Form Health Survey (SF-12v2) at baseline, 3-month, 6-month and 12-month assessments. A repeated measure analysis of variance (ANOVA) evaluated differences in HRQOL scores between treatment groups over time. Multiple imputation was used to impute missing data at each time point. HRQOL data completion rates were 99.7% at baseline, 92.7% at 3-month, 93.9% at 6-month and 92.7% at 12-month after baseline. There were significant mean differences in SF-6D, EQ-5D-5L, FACT-G and SF-12v2 over time except PWB, EWB of FACT-G and mental health of SF-12v2. Mean change of utility scores from baseline between groups did not exceed minimal important difference. No significant treatment group by time interactions were found in all HRQOL and utility scores except in the vitality domain and PCS of SF-12v2 (p-value = 0.033; 0.024). When compared to watchful observation, FNAC intervention was associated with better vitality and physical-related HRQOL scores but did not provide better preservation of utility score improvement over the 12-month period.

Mapping health-related quality of life scores from FACT-G, FAACT, and FACIT-F onto preference-based EQ-5D-5L utilities in non-small cell lung cancer cachexia

BackgroundHealth-related quality of life (HRQoL) measurements from disease-specific tools cannot be directly used in economic evaluations. This study aimed to develop and validate mapping algorithms that predicted EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) utilities from Functional Assessment of Anorexia-Cachexia Therapy (FAACT) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and their common component (Functional Assessment of Cancer Therapy-General—FACT-G) in patients with non-small cell lung cancer cachexia.MethodsData were collected on five occasions over a 12-week period in two multicenter placebo-controlled trials. EQ-5D-5L utilities were calculated using both English and Dutch value sets. The study sample was divided into development and validation datasets according to patients’ geographical residence. Generalized estimating equations were applied to five different sets of independent variables including overall, Trial Outcome Index (TOI), and individual subscales results. The best performing models were selected based on mean absolute error (MAE) and root-mean square error (RMSE).ResultsEQ-5D-5L and FAACT/FACIT-F results were available for 96 patients. The developed algorithms showed a good predictive performance, with acceptable MAE/RMSE and small differences between mean observed and predicted EQ-5D-5L utilities. In FACT-G models, Physical Well-Being had the highest explanatory value, while Emotional Well-Being did not significantly affect the EQ-5D-5L score; Anorexia-Cachexia and Fatigue subscales were highly statistically significant in FAACT and FACIT-F models, respectively, as well as the TOI scores. The Eastern Cooperative Oncology Group status was included as covariate in all models.ConclusionThe developed algorithms enable the estimation of EQ-5D-5L utilities from three cancer-specific instruments when preference-based HRQoL data are missing.

A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication

BackgroundIntermittent claudication is the most common symptom of peripheral arterial disease. Previous research has suggested that extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue. The objective of this feasibility pilot trial was to assess the safety, tolerability, and efficacy of ESWT as a novel treatment. MethodsPatients with unilateral claudication were randomized to receive ESWT or sham treatment to the calf muscle three times per week for 3 weeks. Primary outcomes were pain-free walking distance (PFWD) and maximum walking distance (MWD). Secondary outcomes included safety and tolerability of ESWT treatment, ankle-brachial index before and after exercise, and quality of life assessed using generic (36-Item Short Form Health Survey, EuroQol-5 Dimension 3-Level) and disease-specific (Vascular Quality of Life) instruments. Participants were assessed at baseline and 4, 8, and 12 weeks after treatment. Feasibility outcomes included recruitment and attendance rates for treatment and follow-up. ResultsThirty patients were recruited in total. Statistically significant (P < .05) improvements at all time points were observed in the active treatment group for both MWD and PFWD compared with the sham treatment group. PFWD improved by 276% in the active group and MWD improved by 167% in the active group at 12 weeks after treatment. There were no immediate or delayed treatment safety concerns or documented adverse effects of treatment with ESWT in this trial. ConclusionsESWT is safe and well tolerated when it is applied to the calf and demonstrated significant improvements in walking distances. Current conservative management of intermittent claudication includes supervised exercise. The early results with ESWT as an alternative, noninvasive treatment option show great potential. The mechanism of action, durability of the clinical effect, and cost-effectiveness of ESWT for claudication require further investigation.

Epilepsy, headache, and abdominal pain after shunt surgery for idiopathic normal pressure hydrocephalus: the INPH-CRasH study.

OBJECTIVE Adverse events related to shunt surgery are common and might have a negative effect on outcome in patients with idiopathic normal pressure hydrocephalus (INPH). The authors' objectives were to establish the frequencies of epilepsy, headache, and abdominal pain and determine their impact on patient quality of life (QOL), in long-term follow-up after shunt surgery for INPH. METHODS One hundred seventy-six shunt-treated patients with INPH (mean age 74 years) and 368 age- and sex-matched controls from the population were included. The mean follow-up time after surgery was 21 months (range 6-45 months). Each participant answered a questionnaire regarding present frequency and severity of headache and abdominal pain. Confirmed diagnoses of epilepsy and all prescriptions for antiepileptic drugs (AEDs) before and after shunt surgery for INPH were gathered from national registries. Equivalent presurgical and postsurgical time periods were constructed for the controls based on the date of surgery (the division date for controls is referred to as virtual surgery). All registry data covered a mean period of 6 years (range 3-8 years) before surgery/virtual surgery and 4 years (range 2-6 years) after surgery/virtual surgery. Provoked epileptic seizures were excluded. Patient QOL was assessed with the EuroQoL 5-dimension 5-level instrument. RESULTS Epilepsy was more common in shunt-treated patients with INPH than in controls (4.5% vs 1.1%, respectively; p = 0.023), as was treatment with AEDs (14.8% vs 7.3%, respectively; p = 0.010). No difference was found between the populations before surgery/virtual surgery (epilepsy, 2.3% [INPH] vs 1.1% [control], p = 0.280; AED treatment, 8.5% [INPH] vs 5.4% [control], p = 0.235). New-onset epilepsy and new AED treatment after surgery/virtual surgery were more common in INPH (epilepsy, 2.3% [INPH] vs 0.0% [control], p = 0.011; AED, 8.5% [INPH] vs 3.3% [control], p = 0.015). At follow-up, more patients with INPH than controls experienced headache several times per month or more often (36.1% vs 11.6%, respectively; p < 0.001). Patients with INPH and unilateral headache had more right-sided headaches than controls (p = 0.038). Postural headache was experienced by 16% (n = 27 of 169) of the patients with INPH. Twenty percent (n = 35) of the patients with INPH had persistent abdominal pain. Headache was not correlated to lower QOL. The study was underpowered to draw conclusions regarding QOL in patients with INPH who had epilepsy and abdominal pain, but the finding of no net difference in mean QOL indicates that no correlation between them existed. CONCLUSIONS Epilepsy, headache, and abdominal pain are common in long-term follow-up in patients after shunt surgery for INPH and are more common among patients with INPH than in the general population. All adverse events, including mild and moderate ones, should be considered during postoperative follow-ups and in the development of new methods for shunt placement.

1366P - Effect of nab-paclitaxel/carboplatin (nab-P/C) induction therapy on quality of life (QoL) of patients with squamous (SCC) non-small cell lung cancer (NSCLC) (ABOUND.sqm)

Background: Patients with advanced NSCLC experience a high symptom burden; therefore, identifying a treatment that maintains or improves QoL is important. QoL outcomes in patients with SCC NSCLC receiving nab-P/C in the induction part of the ABOUND.sqm study are reported. Methods: Patients with stage IIIB/IV SCC NSCLC and no prior chemotherapy for metastatic disease received 4 cycles of induction therapy with nab-P 100 mg/m2 days 1, 8, and 15 + C area under the curve 6 on day 1 (21-day cycles). Patients not progressing after induction received (2:1) maintenance nab-P 100 mg/m2 days 1 and 8 (21-day cycles) + best supportive care (BSC) or BSC alone until progression/unacceptable toxicity. The primary endpoint is progression-free survival (randomization to maintenance). Patient-reported QoL (exploratory endpoint) was assessed on day 1 of each cycle using the Lung Cancer Symptom Scale (LCSS) and EuroQoL 5 Dimensions-5 Levels (EQ-5D-5L). Results: In 343 patients receiving treatment in the induction phase were evaluated. Median age was 68 years; 90% were white, 68% male, and 67% had ECOG PS 1. Of 332 patients treated for ≥ 2 cycles, 298 (90%) completed baseline + ≥ 1 postbaseline QoL assessment. During induction, the mean change from baseline in LCSS symptom burden index and total score ranged from 5.5%-7.8% and 5.5%-7.7%, respectively. Clinically meaningful improvements (≥ 10 mm [visual analog scale]) from baseline were observed in composite LCSS pulmonary symptom items of cough, shortness of breath, and hemoptysis in 44% of patients. Each individual dimension of the EQ-5D-5L was maintained/improved from baseline in the majority of patients (82%-91%), and ≥ 32% reported complete resolution at least once during treatment. Conclusions: QoL was improved/maintained in patients with advanced SCC NSCLC treated with nab-P/C induction therapy. These results continue to support nab-P/C as a treatment option in patients with SCC NSCLC, as was initially demonstrated in a subset analysis of the phase III registration trial. NCT02027428. Clinical trial identification: NCT02027428 Legal entity responsible for the study: Celgene Corporation Funding: Celgene Corporation Disclosure: V. Villaflor: Research funding from Celgene and Novartis paid directly to University of Chicago. J. Knoble: Consulting or advisory role for Cardinal Health, Speakers' bureau for Novartis, Alexion and Celgene. M. Thomas: Received honoraria for an advisory/speaker role from: Celgene, Astrazeneca, Roche, BMS, Lilly, Novartis, Boehringer. P. Staib: Honoraria, consulting or advisory role, speaker's bureau and research funding: Celgene. T. Chen, N. Trunova: Employment and Stock Ownership: Celgene. D.R. Spigel: Research funding, consulting or advisory role, and travel, accommodations, expenses: Celgene. All other authors have declared no conflicts of interest.

1367P - Quality of life (QoL) in elderly NSCLC patients (pts) treated with nab-paclitaxel/carboplatin (nab-P/C) in the ABOUND.70+ trial

Background: Treatment of elderly pts with advanced NSCLC remains challenging, and the impact of therapies on QoL can be an important factor in clinical decisions. nab-P/C demonstrated efficacy in a subset of pts ≥ 70 yrs with NSCLC in a phase 3 trial. ABOUND.70+ was designed to determine whether a 1-wk break can further improve tolerability of nab-P/C in these patients. QoL outcomes are reported here. Methods: Pts ≥ 70 yrs with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-P 100 mg/m2 on d 1, 8, and 15 + C AUC 6 on d 1 of a 21-day cycle (Arm A) or the same regimen with a 1-week break between cycles (Arm B). Primary endpoint: percentage of pts with grade ≥ 2 peripheral neuropathy or grade ≥ 3 myelosuppression. Key secondary endpoints: PFS, ORR, OS for which statistical analyses do not control for type I error (P values unadjusted). QoL (exploratory endpoint) was assessed using Lung Cancer Symptom Scale (LCSS) and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) at d 1 of each cycle. Results: At interim evaluation, primary endpoint was similar across arms, resulting in early closure of enrollment. In Arms A and B, 78% and 79% completed a baseline and ≥ 1 postbaseline QoL assessment. LCSS item of cough improved with each cycle; at the end of cycle 6, mean change from baseline in Arms A and B was 25.4 and 13.8 mm (visual analog scale). For cough, median time to deterioration (TTD) was 4.4 and 4.7 mos (P = 0.7003). For the composite LCSS pulmonary symptom items of cough, shortness of breath, and hemoptysis, the median TTD was 4.4 and 6.0 mos (P = 0.3347). Mean maximum improvement (at any point during treatment) in EQ-5D-5L visual analog scale was 10.1 and 12.8 points. Table lists key safety, efficacy and QoL data.Table1367PArm A n = 71Arm B n = 72SafetyPrimary endpoint, n (%)52/68 (76)54/70 (77)P value0.9258Grade ≥ 2 peripheral neuropathy25/68 (37)25/70 (36)Grade ≥ 3 myelosuppression48/68 (71)45/70 (64)Neutropenia39/68 (57)39/70 (56)Anemia14/68 (21)17/70 (24)Thrombocytopenia17/68 (25)12/70 (17)EfficacyConfirmed ORR, %2440P value0.0376PFS, median, months3.67.0P value0.0019HR (95% CI)0.48 (0.30 - 0.76)OS, median, months15.216.2P value0.1966HR (95% CI)0.72 (0.44 - 1.19)QoLMean maximum improvement from baseline, mmLCSS Total score5.811.7LCSS Pulmonary symptom9.214.9 Open table in a new tab Conclusions: These results support nab-P/C as a treatment option in elderly pts with NSCLC. Safety (primary endpoint) and OS were similar across the two arms, while there was a signal of improvement in ORR, PFS, and QoL with a 1-wk break. NCT02151149. Clinical trial identification: NCT02151149 Legal entity responsible for the study: Celgene Corporation Funding: Celgene Corporation Disclosure: C.J. Langer: Consultant/Advisor Role: Celgene. J. Goldman, E. Kim: Research funding: Celgene. K. Konduri: Consultant/Advisory Role: Celgene, Boehringer Ingelheim, DAVA – Pharmaceuticals. A. Sanford, K. Amiri: Employment and stock ownership: Celgene. J. Weiss: Astellas: CME & company sponsored trials (CST); AZ, Biodesix, Clovis, Oncoples: consulting; Celgene: IIT support, CST support, SC; EMD Serono: DSMB member; GSK: IIT support; Medimmune, Pfizer: CST support, IIT support; Merck: CS Tsupport, IIT support. All other authors have declared no conflicts of interest.

Health-related quality of life in relation to disease activity in adults with hereditary angioedema in Sweden.

Health-related quality of life (HR-QoL) is impaired in patients with hereditary angioedema (HAE) but has not yet been satisfactorily described. To study HR-QoL in patients with HAE by combining different HR-QoL instruments with disease activity assessment. All adults in the Swedish HAE registry were invited to take part in this questionnaire study, which used the generic HR-QoL instruments, EuroQol 5 Dimensions 5 Level (EQ-5D-5L) and the RAND Corporation Short Form 36 (RAND-36), the disease-specific Angioedema Quality of Life instrument (AE-QoL), the recently introduced Angioedema Activity Score (AAS) form, and questionnaires on sick leave and prophylactic medication. Sixty-four of 133 adults (26 men, 38 women) between 18 and 91 years old responded. The most affected HR-QoL dimensions in the EQ-5D-5L were pain/discomfort and anxiety/depression; in the RAND-36, energy/fatigue, general health, pain; and, in the AE-QoL, fears/shame and fatigue/mood. Women had lower HR-QoL in the RAND-36 for general health and energy/fatigue (p < 0.05). Patients who reported any AAS of >0 had significantly impaired HR-QoL. There were significant associations (p < 0.05) between the AAS and EQ-5D-5L, between the AAS and all dimensions of the RAND-36 except physical function, and between the AAS and AE-QoL in all dimensions. Nine of 36 patients who reported sick leave during the previous 4 weeks had significantly impaired HR-QoL in all the instruments (p < 0.05). There was no significant difference in HR-QoL in the patients with and the patients without prophylactic medication, except for the nutrition dimension of the AE-QoL (p < 0.05). Comprehensive information is obtained by combining different HR-QoL instruments. Pain, anxiety/depression, and fatigue/mood are important aspects of HAE but the AE-QoL disregards pain. HR-QoL was not significantly affected by prophylaxis. Increased disease activity was associated with impaired HR-QoL, which justifies more active disease management.