Mean EQ-5D Visual Analogue Scale Research Articles

Stereotactic Body Radiotherapy for Oligoprogression in Castration-Resistant Prostate Cancer: Early Toxicity Analysis of the TRAP Trial

AimsTo assess toxicity and patient quality of life after stereotactic body radiotherapy (SBRT) to oligoprogressive disease (OPD) in patients with metastatic castrate-resistant prostate cancer (CRPC) on androgen receptor targeted agents (ARTA). Material and methodsThis phase II trial enrolled patients with metastatic CRPC with ≤ 2 oligoprogressive lesions in bone, lymph node, lung, or prostate. All patients were receiving systemic treatment with abiraterone or enzalutamide at the time of oligoprogression. All patients received SBRT to the OPD site(s) and continued the current ARTA. Patients received 30 Gy in 5 fractions (alternate days) to the OPD site. The primary endpoint of the trial is to assess if SBRT to OPD sites results in progression free survival of >6 months. The primary endpoint for this toxicity analysis is the rate of grade 3 or higher adverse events at any timepoint up to 6 months after SBRT. Secondary endpoints included comparing pre- and post-SBRT patient-related outcomes reported using visual analogue scale scores and EQ-5D health questionnaire. ResultsForty enrolled patients had at least 6 months of follow-up at the time of analysis. Grade 3 or higher toxicity from any cause recorded using common terminology criteria for adverse events and radiation therapy oncology group was found in 8/40 (20%) of patients, but only 1/40 (2.5%) was deemed possibly related to SBRT. There was no significant difference in mean EQ5D visual analogue scale score from baseline to each timepoint after SBRT (p = 0.449). ConclusionIn this prospective phase II clinical trial for OPD whilst on ARTA in the CRPC setting, we report low grade ≥ 3 toxicity after SBRT. There is no discernible change in patient-reported quality of life due to SBRT treatment. The final results of progression-free survival and toxicity of SBRT treatment will be reported once further follow-up is complete.

Shoulder problems after percutaneous antegrade intramedullary nailing in humeral diaphyseal fractures using contemporary straight third-generation nail.

Antegrade intramedullary nailing in humeral shaft fracture has been abandoned by certain orthopedic surgeons because of rotator cuff injury caused by first- and second-generation intramedullary nails (IMNs). However, only a few studies have specifically addressed the results of antegrade nailing for the treatment of humeral shaft fractures with a straight third-generation IMN; thus, complications need to be re-evaluated. We hypothesized that fixation of displaced humeral shaft fractures with a straight third-generation antegrade IMN with the percutaneous technique avoid shoulder problems (stiffness and pain) incurred by first- and second-generation IMNs. This was a retrospective, single-center, nonrandomized study of 110 patients with a displaced humeral shaft fracture between 2012 and 2019 treated surgically with a long third-generation straight IMN. Mean follow-up was 35.6 months (range, 15-44 months). There were 73 women and 37 men with a mean age of 64.7±19 years. All fractures were closed (37.3% 12A1, 13.6% 12B2, and 13.6% 12B3 AO/OTA classification). Mean Constant score was 82±19, Mayo Elbow Performance Score 96±11 and the mean EQ-5D visual analog scale score was 69.7±21.5. Mean forward elevation 150°±40°, abduction 148°±45°, and external rotation 38°±15°. Symptoms associated with rotator cuff disease were present in 6.4%. Evidence of radiographic fracture healing was detected in all but 1 case. One postoperative nerve injury and 1 adhesive capsulitis were present. Overall, 6.3% underwent second surgeries (4.5% were minor surgeries like hardware removal). Percutaneous antegrade intramedullary nailing of humeral shaft fractures with a straight third-generation nail considerably reduced complications related to shoulder problems and achieved good functional results.

The Burden of Migraine on Quality of Life in Chronic Rhinosinusitis.

To determine the impact of comorbid migraine on quality of life (QOL) in chronic rhinosinusitis (CRS). A total of 213 adult patients with CRS were recruited. All participants completed the 22-item Sinonasal Outcome Test (SNOT-22), from which total and validated nasal, ear/facial pain, sleep, and emotional subdomain scores were calculated, and the 5-dimension EuroQol general health questionnaire (EQ-5D), from which the visual analogue scale (VAS) and health utility value (HUV) were calculated. The presence of comorbid migraine was determined by a score of ≥4 on the 5-item Migraine Screen Questionnaire (MS-Q). Of the participants, 36.2% were screened positive for having comorbid migraine. The mean SNOT-22 score was 64.9 (SD: 18.7) in participants with migraine and 41.5 (SD: 21.1) in participants without migraine (p < 0.001). The mean EQ-5D VAS and HUV were 60.2 (SD: 21.9) and 0.69 (SD: 0.18), respectively, in participants with migraine and 71.4 (SD: 19.4) and 0.84 (SD: 0.13), respectively, in participants without migraine (p < 0.001 for both). Higher ear/facial pain (OR=1.22, 95% CI: 1.10-1.36, p < 0.001) and sleep (OR=1.11, 95% CI: 1.04-1.18, p=0.002) SNOT-22 subdomain scores were positively associated with migraine. The SNOT-22 item scores related to dizziness, reduced concentration, and facial pain, in descending order, were most associated with migraine. The presence of nasal polyps (OR = 0.24, 95% CI: 0.07 - 0.80, p = 0.020) was negatively associated with migraine. Comorbid migraine may be relatively common amongst CRS patients, and its presence is associated with significantly worse QOL. Dizziness as a symptom in CRS patients may be particularly indicative of migraine. 3 Laryngoscope, 133:3279-3284, 2023.

Understanding the socioeconomic costs of dystrophic epidermolysis bullosa in Europe: a costing and health-related quality of life study

BackgroundDystrophic epidermolysis bullosa (EB) is a family of rare genetic dermatological conditions. Recent evidence indicated that in addition to its detrimental implications on patient health-related quality of life (HRQoL), there are substantial socioeconomic cost implications, especially regarding direct non-medical costs. This study aims to understand the burden of dystrophic EB (DEB) in Europe, using a primary EB patient-level dataset.MethodsA bottom-up, cross-sectional, study design was adopted for non-institutionalised patients diagnosed with EB who received outpatient care across EU5 countries: France, Germany, Italy, Spain, and the United Kingdom. A prevalence-based approach was used to estimate resource utilisation from a societal perspective, including direct (medical and non-medical) and indirect costs for patients and caregivers. Patient and caregiver outcomes were obtained using the EQ-5D questionnaire.ResultsA sample of 91 DEB patients was analysed. Overall, average EU5 annual cost per patient was estimated at €53,359, ranging from €18,783 (France) to €79,405 (Germany). Average EU5 annual direct medical costs were estimated at €8357 (15.7% of total), ranging from €5658 (France) to €12,576 (Germany); average direct non-medical costs were estimated at €41,353 (77.5% of total), ranging from €11,961 (France) to €57,000 (Germany); and average indirect costs were estimated at €3649 (6.8% of total), ranging from €1025 (Italy) to €9930 (United Kingdom). Costs varied across patients with different disability but also between children and adults. The mean EQ-5D index score for adult DEB patients ranged between 0.304 (United Kingdom) and 0.541 (Germany), with an EU5 average of 0.456, whereas the mean EQ-5D visual analogue scale score ranged between 47.5 (Germany) and 70.0 (France), with an EU5 average of 61.9. Limitations included potential patient selection bias, recall bias, and exclusion of bandaging and related costs.ConclusionsThe study revealed a substantial socioeconomic burden for DEB in Europe, attributable mostly to high direct non-medical costs, with the majority of patients requiring support from caregivers at home. Compared to the average economic burden of the overall EB patient population, costs for DEB patients are higher across all components of direct medical, direct non-medical and indirect costs.

Treatment of Periprosthetic Joint Infection and Fracture-Related Infection With a Temporary Arthrodesis Made by PMMA-Coated Intramedullary Nails - Evaluation of Technique and Quality of Life in Implant-Free Interval.

BackgroundAntimicrobial coating of intramedullary nails with polymethyl methacrylate (PMMA) bone cement promises infection control and stabilization for subsequent bone healing. However, when removing the implant, bone cement can debond and remain in the medullary cavity of the long bones, representing a nidus for reinfection. This work presents a technique comprising reinforcement of PMMA-coated intramedullary nails with cerclage wire to prevent such problems in patients treated for fracture-related infection (FRI) or knee periprosthetic joint infection (PJI) with a static spacer as temporary arthrodesis allowing weight-bearing in the implant-free interval. Outcomes of this surgical treatment were evaluated in terms of (i) associated complications and (ii) patient-reported quality of life.MethodsIn this retrospective case series, 20 patients with PJI (n = 14, 70%) and FRI (n = 6, 30%) treated with PMMA-coated intramedullary nails reinforced with cerclage wire between January 2021 and July 2021 were included. Quality of life during the implant-free interval was evaluated with the EQ-5D, SF-36, and an ICD-10 based psychological symptom rating and compared with previously analyzed cohorts of successfully treated PJI and FRI patients in whom eradication of infection and stable bone consolidation was achieved.ResultsComplications during the implant-free interval comprised a broken nail in one case (5.0%) and a reinfection in one case (5.0%). Coating-specific side effects and cement debonding during removal did not occur. The mean physical health component score of SF-36 was 26.1 ± 7.6, and the mean mental health component score reached a value of 47.1 ± 18.6. The mean EQ-5D index value was 0.36 ± 0.32 and the mean EQ-5D visual analogue scale rating was 47.4 ± 19.4. The scores were significantly lower than those in the successfully treated FRI cohort but not in the PJI cohort. The mean ICD-10-based symptom rating scores revealed psychological symptom burden on the depression scale and enhanced levels of anxiety in comparison with healed FRI and PJI patients.ConclusionReinforcement of PMMA bone cement-coated implants seems to be a reasonable treatment option to create a temporary arthrodesis, preventing detachment of the bone cement when the implant was removed.Level of Evidence: IV.

Burden and Quality of Life Among Female and Male Patients with Heart Failure in Europe: A Real-World Cross-Sectional Study.

PurposeTo characterize symptoms, clinical burden, and health-related quality of life (HRQoL) among women and men with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≤60% in Europe.Patients and MethodsA real-world cross-sectional study was conducted in France, Germany, Italy, Spain, and United Kingdom from June to November 2019. Patient record forms were completed by 257 cardiologists and 158 general practitioners for consecutive patients with HF. The same patients were invited to complete a questionnaire comprising patient-reported outcomes: the Minnesota Living with Heart Failure Questionnaire (MLHFQ), five-level five-dimension EuroQol questionnaire (EQ-5D-5L), Visual Analogue Scale (VAS), and Work Productivity and Activity Impairment questionnaire.ResultsThe mean age of 804 patients (men, n=517; women, n=287) was 68.6 years (men, 67.8 years; women, 70.2 years; p=0.0022). The mean LVEF was 44.7% (men, 43.6%; women, 46.8%; p<0.0001). Patients reported dyspnoea when active (overall, 55.7%; men, 56.0%; women, 55.3%), fatigue/weakness/faintness (34.5%; men, 32.9%; women, 37.2%), and oedema (20.3%; men, 18.7%; women, 23.1%) as the most troublesome HF symptoms. Overall, 54.1% of patients reported low mood/depression (men, 50.8%; women, 60.1%). The overall MLHFQ mean score was higher (ie, poorer HRQoL) among women vs men (37.9 vs 34.6; p=0.0481). MLHFQ was consistently higher (ie, poorer HRQoL) for women vs men across the physical (18.6 vs 16.6; p=0.0041) and emotional (9.4 vs 7.9; p=0.0021) scoring domains. Mean EQ-5D utility (0.69 vs 0.75; p=0.0046) and VAS scores (55.4 vs 61.3; p<0.0001) were lower among women compared with men. Overall, 23.4% of patients were hospitalized owing to HF in the previous year (men, 22.7%; women, 24.6%). Patients reported 43.2% activity impairment due to HF (men, 41.6%; women, 46.4%; p=0.01).ConclusionHF causes a substantial burden on patients, with a greater burden among women vs men. This gender-related difference is consistent with other HF studies, warranting further research to understand the underlying reasons.

Long-term patient-related quality of life after fracture-related infections of the long bones

AimsWe aimed to evaluate the long-term impact of fracture-related infection (FRI) on patients’ physical health and psychological wellbeing. For this purpose, quality of life after successful surgical treatment of FRIs of long bones was assessed.MethodsA total of 37 patients treated between November 2009 and March 2019, with achieved eradication of infection and stable bone consolidation after long bone FRI, were included. Quality of life was evaluated with the EuroQol five-dimension questionnaire (EQ-5D) and German Short-Form 36 (SF-36) outcome instruments as well as with an International Classification of Diseases of the World Health Organization (ICD)-10 based symptom rating (ISR) and compared to normative data.ResultsWith a mean follow-up of 4.19 years (SD 2.7) after the last surgery, the mean SF-36 score was 40.1 (SD 14.6) regarding the physical health component and 48.7 (SD 5.1) regarding the mental health component, compared to German normative values of 48.4 (SD 9.2) (p < 0.001) and 50.9 (SD 8.8) (p = 0.143). The mean EQ-5D index reached 0.76 (SD 0.27) with a mean EQ-5D visual analogue scale (VAS) rating of 65.7 (SD 22.7) compared to reference scores of 0.88 (p < 0.001) and 72.9 (p < 0.001). Mean scores of the ISR did not reveal significant psychological symptom burden, while an individual analysis showed moderate to severe impairments in 21.6% (n = 8) of the patients.ConclusionEven a mean 4.2 years (SD 2.7) after surgically successful treatment of FRI of long bones, patients report significantly lower quality of life in comparison to normative data. Future clinical studies on FRIs should focus on patient-related outcome measures enabling best possible shared treatment decision-making. Prevention methods and interdisciplinary approaches should be implemented to improve the overall quality of life of FRI patients.Cite this article: Bone Joint Res 2021;10(5):321–327.

Social and Economic Costs and Health-Related Quality of Life in Patients With Acute Coronary Syndrome

ObjectivesHealth-related quality of life (HRQOL) evaluation is an important measure of the impact of certain inerventions, epecially coronary artery diseases treatments. As more patients with acute coronary syndrome (ACS) live longer, doctors and researchers want to know how they manage in day-to-day life. The aim of this study was to compare costs and HRQOL of patients who underwent percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and medical therapy (MT) and to assess its main determinants in the whole sample of patients with ACS for a period of 12 months. MethodsThe study was carried out to estimate costs and HRQOL evaluation of 310 patients who underwent coronary revascularization (PCI, n = 139; CABG, n = 128; and MT, n = 43). We estimated direct costs (medical costs and nonmedical costs) and indirect costs (productivity losses owing to morbidity and mortality) based on a societal perspective, and HRQOL was assessed using the EQ-5D-3L (5 dimensions and 3 levels) and visual analog scale (VAS). We applied costs and HRQOL 1 month before treatment and 12 months after treatment in 3 groups, and scores were compared. Data entry and analysis were performed with SPSS. ResultsTotal EQ-5D index scores in PCI, CABG, and MT groups 1 month before treatment were 0.54 ± 0.26, 0.52 ± 0.25, and 0.56 ± 0.25, respectively. After 12 months, the HRQOL mean changed to 0.67 ± 0.20, 0.74 ± 0.15, and 0.65 ± 0.19, respectively, in PCI, CABG, and MT groups. The mean EQ-5D VAS score 1 month before treatment was 63 ± 15.4 for the PCI group, 62 ± 16.4 for the CABG group, and 64 ± 18.4 for the MT group; the mean EQ-5D VAS score 12 months after treatment was 74.8 ± 19.5 for the PCI group, 78.8 ± 18 for the CABG group, and 74 ± 19.7 for the MT group. All the 3 therapeutic strategies presented significant improvement in all dimensions of the follow-up. However, the CABG group was the one that had significantly greater improvement compared with PCI and MT. The mean (95% confidence interval) annual total cost for the overall sample was found to be $4940/patient. This cost was significantly higher among patients with CABG ($7327/patient) compared with PCI ($5225/patient) and MT ($2278/patient). Direct costs accounted for 87.7% and indirect costs for 12.3% of the total costs. ConclusionThe quality of life was better in both CABG and PCI groups compared with MT after 1 year of follow-up. However, treatment with CABG is more difficult and expensive than PCI and MT, but it provides a better quality of life. The findings of the present study indicate the high economic burden of ACS in Iran.

Impact of Hemophilia a Inhibitor on Joint Health and Health-Related Quality of Life from the Hemophilia Utilization Group Studies Part VIII in the U.S

Introduction: Persons with hemophilia A (PwHA) and Factor VIII inhibitors experience significant economic burden associated with high treatment costs and compromised physical and psychosocial health. Few studies have compared burden of illness for PwHA with active inhibitors to those with tolerized or no inhibitor. We describe clinical and treatment outcomes, and health-related quality of life (HRQoL) in PwHA with and without inhibitors using the Hemophilia Utilization Group Studies Part VIII (HUGS VIII) baseline cross-sectional data. Methods: HUGS VIII prospectively examines the cost and burden of hemophilia care, including HRQoL, arthropathy, and psychosocial impact in PwHA aged ≥2 years. The study enrolled PwHA with inhibitors and without inhibitor at a 1:2 ratio. Participants were classified to three groups: 1) active inhibitor (FVIII≥1.0 Bethesda Units within six months of data extraction), 2) presumably tolerized inhibitor (history of immune tolerance induction, ITI, and using factor VIII for prophylaxis), and 3) no inhibitor. Parents/adult participants completed a standardized interview at enrollment (baseline) to collect sociodemographic and clinical data, self-reported pain, joint health, and HRQoL measured by the EQ-5D-3L. Clinical chart review documented hemophilic severity, inhibitor level and treatment regimen. Associations between participants' characteristics and inhibitor status were assessed using Chi-square tests. Results: Data from 73 participants with complete baseline information were analyzed. Mean age was 24.8 (standard deviation (SD)=14.1) years, 65.8% were adults, 87.7% had severe hemophilia A, and 87.1% self-reported receiving prophylactic treatment. The three groups of participants were: non-inhibitor (n=42, 57.5%); tolerized inhibitor (n=23, 31.5%); and active inhibitor (n=8, 11.0%). Mean age among the tolerized inhibitor group was significantly younger (17.3, SD=9.3 years) than active inhibitor (22.6, SD=20.4) or non-inhibitor groups (29.3, SD=13.3), p=0.02. Among individuals with inhibitors, 78.6% had undergone ITI which was successful in 72.2%. Adult participants/parents in the active inhibitor group reported a lower rate of full-time employment (42.9%) compared to the non-inhibitor (58.5%) or tolerized inhibitor (55.7%) groups, p=0.03. Compared to those without inhibitors or tolerized inhibitors, those with active inhibitors showed lower HRQoL with lower covariates adjusted mean EQ-5D Visual Analogue Scale (73.1 vs. 83.6, 80.2, P=0.21) or index score (0.80 vs. 0.87, 0.88, P=0.57). Participants with active inhibitors and those without inhibitors were more likely to report having joint pain (85.7%, 75.6% non-inhibitors, vs. 59.1% tolerized inhibitors, p=0.26), or very stiff joints upon arising (71.4%, 73.2%, vs. 27.3%, p=0.002) or during the day (71.4%, 63.4% vs. 27.3%, p=0.01) than those with a tolerized inhibitor, likely due to younger age and earlier institution of long-term effective prophylaxis after ITI. Conclusions: While the study is limited to a small sample with a skew to younger age in persons with tolerized inhibitors, preliminary analyses indicate that individuals with active inhibitors experienced greater negative impacts on employment and HRQoL than PwHA with no or tolerized inhibitors. Younger persons with tolerized inhibitors showed better joint health (less pain, stiffness) than older persons with active or no inhibitor. Future research using longitudinal data on these participants will examine whether individuals in the tolerized inhibitor group with successful ITI continue with long-term prophylaxis and achieve positive joint health outcomes. Disclosures Roberts: uniQure: Consultancy; Takeda: Consultancy, Research Funding, Speakers Bureau; Pfizer: Consultancy; Novo Nordisk: Consultancy, Speakers Bureau; Sanofi: Consultancy, Speakers Bureau; Octapharma: Consultancy, Speakers Bureau. Khairnar:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company; F Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Wu:Baxalta US Inc., Bannockburn, IL (a Takeda Company), CSL Behring L.L.C., and Octapharma USA, Inc.: Research Funding. Carrasco:Baxalta US Inc., Bannockburn, IL (a Takeda Company), CSL Behring L.L.C., and Octapharma USA, Inc.: Research Funding. Curtis:Bayer: Consultancy; USC Hemophilia Utilization Group Study (HUGS): Consultancy; Novo Nordisk: Consultancy; Patient Reported Outcomes, Burdens and Experiences: Consultancy. Tran:Bioverativ: Consultancy; Novo Nordisk: Consultancy; Bayer: Consultancy; Takeda: Consultancy. Nichol:Pfizer: Research Funding; Octapharma: Research Funding; CSL Behring: Research Funding; Global Blood Therapeutics: Research Funding; Baxalta US Inc., Bannockburn, IL (a Takeda Company): Research Funding; Genentech Inc.: Research Funding.

Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA

BackgroundWe evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study.MethodsIn this exploratory trial, subjects (N = 155; 18–80 years of age) with upper- and lower-limb spasticity due to cerebral causes who were deemed to require total body doses of up to 800 U incobotulinumtoxinA received three consecutive injection cycles of incobotulinumtoxinA (400, 600, and up to 800 U), each with 12 to 16 weeks’ follow-up. QoL was assessed using the EuroQol 5-dimensions questionnaire, three-level (EQ-5D), before and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3.ResultsThe mean EQ-5D visual analog scale scores of 155 participants continuously improved from study baseline to 4 weeks post-injection in all injection cycles (mean [standard deviation] change 6.7 [14.1], 9.6 [16.3], and 8.6 [17.0] for injection cycles 1, 2, and 3, respectively; p < 0.0001 for all, paired sample t-test). In general, among those with a change in the EQ-5D rating of their condition, the proportion of subjects with ‘improvement’ was greater than that with ‘worsening’ for individual EQ-5D dimensions across all injection cycles. At the end of injection cycle 3, the proportion of subjects rating their condition as ‘normal’ increased from study baseline for all dimensions, and there was a ≥ 46% reduction in the proportion of subjects with a rating of ‘severe impairment’.ConclusionThese preliminary results suggest that escalating incobotulinumtoxinA doses up to 800 U are associated with improvement in quality of life ratings in subjects with multifocal upper- and lower-limb spasticity, and form a basis for future comparator studies.Trial registrationClinicalTrials.gov, NCT01603459. Date of registration: May 22, 2012.

A real-world, cross-sectional, community survey of symptoms and health-related quality of life of adults with acute myeloid leukemia.

Aim: We used Adelphi Real World Disease-Specific Programme data to characterize adults with newly diagnosed or relapsed/refractory de novo acute myeloid leukemia (AML). Materials & methods: Community-practice hematologists/oncologists completed patient record forms for their regular AML patients. Patients were invited to complete patient self-completion forms including 3-Level EuroQol 5-Dimensions (EQ-5D-3L) and Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaires. Results: Physicians provided patient record forms for 389 patients (339 newly diagnosed, 50 relapsed/refractory); 68 patients completed patient self-completion forms. Mean EQ-5D visual-analog scale and index and FACT-General scores were significantly lower than US population norms (p<0.0001); health-related quality of life (HRQoL) scores were generally lower than 11 other cancers. Conclusion: HRQoL impairment is grave in AML. Efforts are needed to improve HRQoL in affected patients.

Impact of Transcatheter Aortic Valve Implantation on Symptoms and Quality of Life in Australian Patients: Insights from the ACOR TAVI Registry

Objective: To evaluate the health status outcomes of TAVI patients using two standardised and validated patient-reported outcome measures (PROMs). Methods: From April to October 2018, TAVI Registry patients were requested via phone, email, mail or direct contact to complete the PROMs at two timepoints: pre-procedure (416 patients) and 30-day follow-up (273 eligible patients). The PROMs include: a generic quality of life questionnaire, the EQ-5D and a disease specific instrument, the Kansas City Cardiomyopathy Questionnaire (KCCQ). Results: The cohort mean age was 83 years (range 59-87) and 57% male. For both PROMs there was a high completion rate: the pre-procedure timepoint (KCCQ n = 384 (92%), EQ5D n = 390 (94%)) was lower than at 30-days (KCCQ n = 262 (96%) EQ5D n = 264 (97%)). The mean KCCQ-overall score increased from 49.7 ± 22.7 pre-procedure to 76.0 ± 21.2 at 30-days (p value < 0.0001). All KCCQ domains increased when comparing pre-procedure and 30-day follow-up. The overall mean EQ5D visual analogue scale (score 0-100) increased from 59.8 ± 18.9 to 72.9 ± 17.0 at 30-days (p value < 0.001). A comparison of pre-procedure and 30-day follow-up data using EQ5D showed a significant increase in all five domains. Conclusion: A dramatic improvement at 30-days is being reported by patients supporting the clinical benefits of the TAVI procedure. This significance was demonstrated throughout all domain variables and as an overall score in both PROMs. As the TAVI Registry reaches its 1-year timepoint, it is expected the outcomes will continue to improve which aligns with the PROMs data reported from other international registries.

P3.01-109 Real-World Patient-Reported Outcome Assessment of Patients with Metastatic Non-Small Cell Lung Cancer

Patient-Reported Outcomes (PROs) provide information on patient treatment experience. We have established a real-world Advanced Non-Small Cell Lung Holistic Registry (ANCHoR) to understand how the advent of immunotherapy impacts treatment choice, clinical outcomes, and PROs of metastatic non-small cell lung cancer (mNSCLC). The aim of this analysis is to report early results of baseline symptom status and quality of life among mNSCLC patients using the MD Anderson Symptom Inventory lung cancer module (MDASI-LC) and EuroQol-5D 5-level version (EQ-5D-5L). During 2017, patients with mNSCLC at a single institution were enrolled in ANCHoR and completed the PRO questionnaires at clinic visits. MDASI-LC consists of thirteen core and three lung cancer-specific symptom severity questions, and six interference items rated on 0-10 scales (0 = no symptom or interference, 10 = worst imaginable symptom or complete interference). EQ-5D-5L captures five health state dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression rated on a five-level scale (1= no problems, 5= extreme problems). A single visual analogue scale (VAS) on EQ-5D-5L records patient self-rated health between ”best imaginable” (100) and “worst imaginable” (0) health state. Descriptive statistics for PRO scores at baseline are summarized. Forty-two patients completed baseline PROs before the start of therapy. Mean patient age was 63 years and 45% were males. For MDASI-LC, the mean scores for the core symptom, lung cancer-specific symptom, and interference subscales at baseline were 2.2 (standard deviation [SD] = 2.80), 2.1 (SD = 2.80), and 2.8 (SD = 3.10), respectively. Fatigue was the most severe symptom reported at baseline (mean = 4.1, SD = 3.01), followed by shortness of breath (mean = 3.2, SD = 2.81) and pain (mean = 3.19, SD = 3.00). The highest percentages of patients reporting moderate to severe symptom levels (score of ≥5) were 38% for fatigue, 33% for pain, 31% for drowsiness, 29% for shortness of breath and disturbed sleep, and 26% coughing. For EQ-5D-5L, 91% of patient reported problems with self-care, 81% with mobility, 48% with usual activity and anxiety, and 33% with pain. Mean EQ-5D VAS was 73.9 (SD = 18.2). Prior to the start of treatment, fatigue, pain, drowsiness, disturbed sleep, and coughing were the most common symptoms with fatigue, shortness of breath, and pain being the most severe. Additional follow up will confirm and expand these findings and will also allow us to examine change in PROs after first-line treatment is administered.

Quality of life in patients with primary and secondary lymphedema in the community.

Lymphedema is a complex and burdensome medical problem and requires continuous specific therapy. The aim of this cross-sectional study of community lymphedema care in the metropolitan area of Hamburg, Germany, was to evaluate health-related quality of life (QoL) in lymphedema patients. Generic as well as disease-specific health-related QoL was assessed using EQ-5D and FLQA-LK, respectively. Pain was assessed using a visual analogue scale (VAS). About 301 patients (median age of 60.5 years, 90.8% female) with lymphedema of any origin were included. About 66.4% had lymphedema, 24.1% combined lipolymphedema, and 9.5% lipoedema. Mean disease-specific QoL (FLQA-LK) was 2.4 (range 0 = no to 4 = maximum burden). The highest impairment values were observed in subscales for physical complaints, everyday life, and emotional well-being. Mean EQ-5D VAS was 70.4, mean EQ-5D score 63.3. Lymphedema was associated with major impairments in QoL, which differed for subgroups of pain, clinical severity, and comorbidity. Pain as a common problem for lymphedema patients seemed to be underestimated and undertreated. Early diagnosis and structured treatment strategies are urgently needed.

Self-reported prevalence, description and management of pain in adults with haemophilia: methods, demographics and results from the Pain, Functional Impairment, and Quality of life (P-FiQ) study.

Haemophilia is characterized by frequent haemarthrosis, leading to acute/chronic joint pain. To assess self-reported prevalence, description and management of pain in adult males with mild-to-severe haemophilia and history of joint pain/bleeding. Participants completed a pain survey and five patient-reported outcome instruments assessing pain, functional impairment and health-related quality of life (HRQoL). Of 381 participants enrolled, median age was 34 years; 77% had haemophilia A, 71% had severe disease and 65% were overweight/obese. Many (56%) were not receiving routine infusions; 30% never received routine infusions. During the prior 6 months, 20% experienced acute pain, 34% chronic pain and 32% both acute/chronic pain. Subjects with both acute/chronic pain (vs. none, acute or chronic) were more likely to be depressed (30% vs. 0-15%), obese (35% vs. 20-29%) and have lower HRQoL (mean EQ-5D visual analog scale, 69 vs. 83-86) and function (median overall Hemophilia Activities List, 60 vs. 88-99). Most common analgesics used for acute/chronic pain during the prior 6 months were acetaminophen (62%/55%) and non-steroidal anti-inflammatory drugs (34%/49%); most common non-pharmacologic strategies were ice (65%/33%) and rest (51%/33%). Hydrocodone-acetaminophen was the most common opioid for both acute/chronic pain (30%); other long-acting opioids were infrequently used specifically for chronic but not acute pain (morphine, 7%; methadone, 6%; fentanyl patch, 2%). Patients with chronic pain, particularly those with both acute/chronic pain, frequently experience psychological issues, functional disability and reduced HRQoL. Treatment strategies for acute pain (e.g. routine infusions to prevent bleeding) and for chronic pain (e.g. long-acting opioids) may be underused.

Factors associated with the quality of life of Korean COPD patients as measured by the EQ-5D.

This study evaluated the health-related quality of life measured using the EuroQol five-dimension questionnaire (EQ-5D) and the degree of airway obstruction in a Korean population using Korea National Health and Nutritional Examination Survey (KNHANES IV-V, 2007-2010) data. A cross-sectional analysis examined 2356 subjects (1178 COPD patients, 1178 control subjects) aged ≥40 years and performed reliable spirometry as part of KNHANES IV-V. Baseline EQ-5D visual analog scale (VAS) and EQ-5D utility scores were obtained. A Tobit censored regression model was used to evaluate factors affecting EQ-5D in COPD patients. The EQ-5D VAS and EQ-5D utility scores were significantly different among the COPD severity groups (P < 0.05). The mean EQ-5D VAS scores for patients with mild, moderate, and severe COPD were 73.0 (SD 18.6), 70.8 (19.1), and 60.9 (23.4), respectively. The mean utility scores were 0.90 (0.14) for patients with mild COPD, 0.89 (0.14) for patients with moderate COPD, and 0.84 (0.15) for patients with severe COPD. Factors influencing the EQ-5D utility score in patients with COPD were age, gender, household income, education level, severe airflow obstruction, and comorbidities. The EQ-5D score could be a useful instrument for evaluating the quality of life of COPD patients in Korea. In Korean COPD patients, the main determinants of EQ-5D scores include older age, female gender, lower household income, lower education level, severe airflow obstruction, and many comorbid diseases.

After critical care: Patient support after critical care. A mixed method longitudinal study using email interviews and questionnaires

To explore experiences and needs over time, of patients discharged from ICU using the Intensive Care Experience (ICE-q) questionnaire, Hospital Anxiety and Depression Scale (HADS) and EuroQoL (EQ-5D), associated clinical predictors (APACHE II, TISS, Length of stay, RIKER scores) and in-depth email interviewing. A mixed-method, longitudinal study of patients with >48hour ICU stays at 2 weeks, 6 months, 12 months using the ICE-q, HADS, EQ-5D triangulated with clinical predictors, including age, gender, length of stay (ICU and hospital), APACHE II and TISS. In-depth qualitative email interviews were completed at 1 month and 6 months. Grounded Theory analysis was applied to interview data and data were triangulated with questionnaire and clinical data. Data was collected from January 2010 to March 2012 from 77 participants. Both mean EQ-5D visual analogue scale, utility scores and HADS scores improved from 2 weeks to 6 months, (p=<0.001; p=<0.001), but between 6 and 12 months, no change was found in data from either questionnaire, suggesting improvements level off. These variations were reflected in qualitative data themes: rehabilitation/recovery in the context of chronic illness; impact of critical care; emotional and psychological needs (including sub-themes of: information needs and relocation anxiety). The overarching, core theme related to adjustment of normality. Patient recovery in this population appears to be shaped by ongoing illness and treatment. Email interviews offer a convenient method of gaining in-depth interview data and could be used as part of ICU follow-up.

Decline in self-reported health (EQ-5D) over time after surgical reconstruction of the right ventricular outflow tract: a longitudinal cohort study of 103 patients.

Patients with congenital heart disease may be operated with surgical reconstruction of the right ventricular outflow tract (RVOT). Reintervention is common in this group of patients. The aim of this study was to examine longitudinal self-reported health measured by the EQ-5D questionnaire. Data were collected from the Swedish Registry of Congenital Heart Disease. EQ-5D, which measures health outcome, was introduced into the registry in 2005. All adult patients with previous surgical reconstruction of the RVOT who had EQ-5D data from their first and latest visit were analyzed. Among 103 patients (65 male and 38 female), mean age 31 (range 19-78 years), the diagnoses were: tetralogy of Fallot (n = 66); truncus, transpositions, and double outlet right ventricle (n = 23); and Ross-operated congenital aortic valve disease (n = 14). Time from first to latest visit was 3 years (range 1-7 years). Eighteen patients underwent 26 reinterventions in the observational period from the first to latest visit, including operations, percutaneous interventions, pacemaker implantations, and ablations. Health perception, mean EQ-5D visual analog scale, VAS, declined from 84.4 (standard deviation (SD) = 14.6) to 78.6 (SD = 18.3) at the latest visit, P = .001. The decline is almost exclusively seen in patients without reinterventions. Low EQ-VAS was associated with symptoms and New York Heart Association class II-IV. Patient-reported problems in the EQ-5D dimension usual activities were more common in the patients having reinterventions (25%) than those without reintervention (7%), P = .04. In this longitudinal cohort study of patients with previous surgical reconstruction of the RVOT, health perception declined over time. The decline was not observed in patients undergoing any additional interventions.

Ethnic differences in health related quality of life for patients with type 2 diabetes.

BackgroundThe objective of this study was to investigate the association between ethnicity and health related quality of life (HRQoL) in patients with type 2 diabetes.MethodsThe EuroQol EQ-5D measure was administered to 1,978 patients with type 2 diabetes in the UK Asian Diabetes Study (UKADS): 1,486 of south Asian origin (Indian, Pakistani, Bangladeshi or other south Asian) and 492 of white European origin. Multivariate regression using ordinary least square (OLS), Tobit, fractional logit and Censored Least Absolutes Deviations estimators was used to estimate the impact of ethnicity on both visual analogue scale (VAS) and utility scores for the EuroQol EQ-5D.ResultsMean EQ-5D VAS and utility scores were lower among south Asians with diabetes compared to the white European population; the unadjusted effect on the mean EQ-5D VAS score was −7.82 (Standard error [SE] = 1.06, p < 0.01) and on the EQ-5D utility score was −0.06 (SE = 0.02, p < 0.01) (OLS estimator). After controlling for socio-demographic and clinical confounders, the adjusted effect on the EQ-5D VAS score was −9.35 (SE = 2.46, p < 0.01) and on the EQ-5D utility score was 0.06 (SE = 0.04), although the latter was not statistically significant.ConclusionsThere was a large and statistically significant association between south Asian ethnicity and lower EQ-5D VAS scores. In contrast, there was no significant difference in EQ-5D utility scores between the south Asian and white European sub-groups. Further research is needed to explain the differences in effects on subjective EQ-5D VAS scores and population-weighted EQ-5D utility scores in this context.

Patient-Reported Knee Function, Quality of Life, and Activity Level After Bilateral Anterior Cruciate Ligament Injuries

Background: About 12% of patients who have undergone primary anterior cruciate ligament (ACL) reconstruction sustain a contralateral ACL injury within 5 years. Purpose: To investigate patient-reported knee function, quality of life, and activity level in patients with bilateral ACL injuries. Study Design: Cohort study; Level of evidence, 3. Methods: A search of hospital records identified 147 patients, aged 18 to 45 years, with bilateral ACL injuries. Of these, 83 met the inclusion criteria, having had their first ACL injury up to 12 years ago with no other major injuries to the knee joint. Sixty-six of these patients (80% of total; 47% female; mean age, 29.1 ± 7.2 years) answered a questionnaire packet. Patients who had undergone unilateral ACL reconstruction (n = 182) were used for comparison. Results: Patients with bilateral ACL injuries had a median Lysholm knee score of 82 (range, 34-100). The mean EuroQol index (EQ-5D) score of the overall health status was 0.77 ± 0.22, and the mean EQ-5D visual analog scale score was 75.5 ± 17.6. The median Tegner activity level was 9 (range, 1-9) before any injuries, 7 (range, 1-9) before the second ACL injury, and 4 (range, 1-9) at the time of follow-up. The activity level before the second injury was higher compared with the follow-up for patients who had undergone unilateral ACL reconstruction. At follow-up, 23% of the patients with bilateral ACL injuries returned to their previous activity, and 12% of patients returned to the same level as before their injuries compared with 43% (P = .004) and 28% (P = .01) in patients who had undergone unilateral ACL reconstruction, respectively. Patients with bilateral ACL injuries had significantly lower values in the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales for pain, function in sports and recreation, and knee-related quality of life as well as the ACL Deficiency Quality of Life (ACL-QOL) score compared with patients who had undergone unilateral ACL reconstruction. Conclusion: Patients with bilateral ACL injuries reported poorer knee function and quality of life compared with those who had undergone unilateral ACL reconstruction. Their activities had changed, and they were dissatisfied with their current activity level. They had a high activity level before their first and second ACL injuries but an impaired activity level after their contralateral injury at follow-up.