EQ-5D Visual Analogue Scale Research Articles

Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial.

Parastomal hernias are often repaired with mesh to reduce recurrences, but the presence of an ostomy increases the wound class from clean to clean-contaminated/contaminated and makes the choice of mesh more controversial than in a strictly clean case. We aimed to compare the outcomes of biologic and synthetic mesh for parastomal hernia repair. This is a post hoc analysis of parastomal hernia repairs in a randomized trial comparing biologic and synthetic mesh in contaminated ventral hernia repairs. Outcomes included rates of surgical site occurrences requiring procedural intervention (SSOPI), reoperations, stoma/mesh-related adverse events, parastomal hernia recurrence rates (clinical, patient-reported, and radiographic) at 2 years, quality of life (EQ-5D, EQ-5D Visual Analog Scale, and Hernia-Related Quality of Life Survey), and hospital costs up to 30 days. A total of 108 patients underwent parastomal hernia repair (57 biologic [53%] and 51 synthetic [47%]). Demographic and hernia characteristics were similar between the two groups. No significant differences in SSOPI rates or reoperations were observed between mesh types. Four mesh erosions into an ostomy requiring reoperations (2 biologic vs 2 synthetic) occurred. At 2 years, parastomal hernia recurrence rates were similar for biologic and synthetic mesh (17 [29.8%] vs 13 [25.5%], respectively; p = .77). Overall and hernia-related quality of life improved from baseline and were similar between the two groups at 2 years. Median total hospital cost and median mesh cost were higher for biologic compared with synthetic mesh. Biologic and synthetic mesh have similar wound morbidity, reoperations, 2-year hernia recurrence rates, and quality of life in parastomal hernia repairs. Cost should be considered in mesh choice for parastomal hernia repairs.

Relationship between generic instruments used to measure healthrelated quality of life same or different

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Swedish research Council for Medicine and health - VR Swedish Research Council for health, working life and welfare - FORTE Background Health-related quality of life (HRQoL) is one and possibly the most important follow-up measure that is used to assess outcomes after long term and critical illness, such as heart failure. There is today an abundance of available generic measures relevant for all types of diseases and health states, and therefore suitable in heterogenous patient cohorts. Globally, two of the most common generic measures of HRQoL in use today are the EuroQol-5D (EQ-5D) and the RAND-36/36-item short-form SF-36. Another commonly used instrument is Cantril’s ladder of life. With the purpose to create a valid but not burdensome survey before and after an intervention in a cohort of former critically ill patients after a period of cardiac care, the question was raised what instrument to choose, and if the instruments correlates. If so, not all items have to be used if they measure the same outcome. Purpose To examine the relationship between different generic instruments for HRQoL in patients with heart failure. Methods For EQ-5D the separate five separate dimensions, the index from the combined dimensions, and a visual analog scale (VAS) can be used. For RAND-36 the eight dimensions created from 35 of the 36 questions, and the extern item as a single item called "Health Transition" can be used. Finally, for the Ladder of life the three questions can be used as separate items. The items chosen and measured in a cohort of former critically ill cardiac patients (n=246) were EQ-5D VAS, EQ-index, RAND-36 health transition question, and ladder of life question 1 and 3. Higher scores indicates higher perceived HRQoL on the scales except for RAND-36. The patients had a mean age of 66 years (SD 11.8), 67.3% (n=165) were men. The most common diagnoses in the sample were heart failure 68% (n=148), diabetes 22% (n=31), cancer (17% (n=36), and pulmonary disease 14% (n=31). The Spearman´s rank correlation was used to analyze the strength of association in the nonparametric data. Results Up to moderately strong correlation was seen between the items (see table). The strongest correlation was found between the EQ-5D VAS and RAND-36 Health Transition item (-0,629 (p=0.01)), followed by both RAND-36 and EQ-5D VAS and the ladder of life question "Where on the ladder do you feel you personally stand right now" (0,615 (p=0.01)) and (0.606 (p=0.01)) respectively. The two ladder of life questions correlated moderately (0.689, (p=0.01)). Conclusions Albeit the same focus area, the chosen general instruments, and items for measuring HRQoL was not strongly correlated indicated that they do not measure the exact same concepts and dimension. This is of importance when chosen instruments for HRQoL follow-up. There might be a need to combine more than one generic instrument considering the balance between the burden for the patient and the purpose and depth of the investigation. Further conceptual consideration regarding to these different generic instruments are warranted.

A prospective study on sex differences in functional capacity, quality of life and prognosis in patients with heart failure.

Background:Due to the lack of evidence and inconsistency of sex differences in Heart failure (HF) in the Chinese population, this study aimed to compare sex differences in functional capacity and quality of life (QoL) between women and men after standard HF medications therapies, and analyze whether sex differences were associated with the composite endpoints of all-cause mortality or HF-related hospitalization and cardiac event-free survival rate in Chinese patients with HF.Methods:This was a 1-year longitudinal study. Participants included patients with HF from March 2017 to December 2018. At baseline and followed up at 1, 6, and 12 months later, functional capacity was assessed by 6-minute walk testing (6MWT), QoL was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL five dimensions (EQ-5D). The Cox proportional hazards model and Kaplan-Meier curves were used to determine sex differences in subsequent outcomes. The Cox proportional hazards model was used to identify the risk factors for composite endpoints. Kaplan-Meier curves were used to compare survival.Results:All patients were assigned to either men group (n = 94) or women group (n = 60). Longitudinal follow-ups showed a continuously increasing in 6MWT, Kansas City Cardiomyopathy Questionnaire overall score, EQ-5D visual analogue scale, and EQ-5D Index score in both groups (all P < 0.001); however, women reported a lower level of all parameters at the 1, 6, and 12 months follow-ups (all P < 0.05). In addition, women had a higher risk of all-cause mortality or HF-related hospitalization and a lower cardiac event-free survival rate than men (log-rank test, P = 0.027).Conclusion:Women reported worse functional capacity, QoL, and prognosis than men in a sample of Chinese patients with HF. Our findings highlight the importance of paying attention to sex differences in HF.

P1717: HEALTH-RELATED QUALITY OF LIFE AND TOLERABILITY OF LONCASTUXIMAB TESIRINE IN HIGH-RISK PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA TREATED IN A PHASE 2 CLINICAL TRIAL (LOTIS 2)

Background: Loncastuximab tesirine (loncastuximab tesirine-lpyl; Lonca) has shown antitumor activity with an acceptable toxicity profile and provides stable or improved health-related quality of life (HRQOL) in adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) after ≥ 2 prior therapies. Lonca has also shown promising results for patients who are at high risk of a poor prognosis (i.e., with double/triple hit, primary refractory, or transformed disease). Aims: This analysis evaluates the impact of Lonca on HRQOL and patient tolerability to treatment stratified by high-risk group. Methods: The LOTIS 2 study (NCT03589469) is a single-arm, open-label, phase 2 study of adult patients with R/R DLBCL after ≥ 2 prior treatments. Patients received Lonca as an intravenous infusion on day 1 of each 3-week treatment cycle. The EuroQol EQ-5D visual analog scale (VAS) was used to measure overall health state, and the Functional Assessment of Cancer Treatment–Lymphoma (FACT-Lym) was used to measure HRQOL, including physical, social/family, emotional, and functional well-being, and lymphoma-specific symptoms and concerns. Mean change from baseline scores during the treatment period were summarized by visit and risk group. Analysis of covariance (ANCOVA) models were conducted to adjust for age, sex, race, and baseline score. Treatment tolerability was reported by patients in FACT-Lym item GP5 (“I am bothered by side effects of treatment”). This single item has been used to measure overall side effect impact on patients. All patients provided written informed consent to participate the study. Results: Patients with a baseline score and at least one postbaseline score were included in the analysis. Through cycle 9, the completion rate among patients treated at each cycle was ≥ 92% for EQ-5D and ≥ 88% for FACT-Lym. Of the 127 patients included in analysis, 16% were aged ≥ 75 years, 58% were male, 88% were White, and 39% were high risk. In the high-risk group, both unadjusted and adjusted analyses showed the VAS overall health score was improved after 2 cycles of treatment (figure and table); the FACT-Lym total score was also improved at some visits. In the non–high-risk group, the VAS and FACT-Lym total scores remained stable or improved except later cycles with small sample sizes. When asked how much they were bothered by treatment side effects, a majority of patients reported “a little bit” or “not at all” at most cycles (71%-89% in the high-risk group and 46%-86% in the non–high-risk group). Table. - Adjusted Mean Change From Baseline Scores of EQ-5D VAS and FACT-Lym Total Least Squares Means by Visit C2D1 C3D1 C4D1 C5D1 C6D1 C7D1 C8D1 C9D1 EQ-5D VAS High risk -0.6 6.8* 7.5** 5.8 0.3 8.7 13.0* 9.9 Non-high risk 0.1 2.1 3.3 1.5 2.5 1.6 7.7 8.5 Difference -0.7 4.7 4.2 4.4 -2.2 7.1 5.3 1.4 FACT-Lym total High risk -0.7 6.7 6.8 2.5 14.1** 24.5** 29.1** 20.6** Non-high risk 2.6 4.7 3.9 2 4.2 9.9 8.8 17.9** Difference -3.3 2 2.9 0.6 9.9 14.6* 20.3** 2.7 * 0.05 < P < 0.10; ** P <0.05. Age, sex, race, and baseline score were adjusted in the ANCOVA model. Visits after C9D1 are not displayed due to small sample sizes. A change of 7 points for the EQ VAS or FACT-Lym total is considered a minimally important difference. A positive change indicates improvement. Image:Summary/Conclusion: The overall health state and HRQOL were stable or improved in high-risk patients during the treatment period of Lonca. Patients in the high-risk group tolerated the treatment just as well, if not better, as other patients. The findings further support the clinical use of Lonca for the treatment of R/R DLBCL in patients with high risk.

Malignant pleural mesothelioma: treatment patterns and humanistic burden of disease in Europe

BackgroundMalignant pleural mesothelioma (MPM) is an aggressive and rare tumour with poor prognosis. Most patients are diagnosed with advanced disease and there is a paucity of data on the humanistic burden of MPM in terms of impact on health-related quality of life (HRQoL) and activity. This study examined real-world treatment patterns and humanistic disease burden of MPM in Europe.MethodsPhysicians abstracted demographic/clinical characteristics and treatment data from MPM-patient medical records; MPM patients self-completed a questionnaire including symptoms, 3-level-EQ-5D questionnaire and Visual Analogue Scale (VAS), Lung Cancer Symptom Scale for Mesothelioma (LCSS-Meso), and Work Productivity and Activity Impairment (WPAI) questionnaire.ResultsPhysicians (n = 171) abstracted data of 1390 patients; 767/1390 patients self-completed questionnaires. Patients were elderly with advanced, unresectable MPM. Treatment patterns followed guidelines with most (81%) patients receiving platinum+antifolate chemotherapy at first line (1 L). Maintenance treatment use was high (51.1%) despite no recommended maintenance therapies. Symptom burden was high and health states and HRQoL were poor at 1; declining further with progression. Overall mean (SD): LCSS-Average Symptom Burden Index score was 48.8 (19.3; n = 758); EQ-5D Utility Index score was 0.510 (0.349; n = 763); EQ-5D VAS score was 54.2 (20.3;n = 766); LCSS-3-Item Global Index score was 143.2 (64.5; n = 762); LCSS-normal activities score was 51.9 (24.6;n = 765); WPAI-activity impairment was 56.0% (23.2%; n = 737).ConclusionThe humanistic burden of MPM is high, despite treatments being prescribed as per available guidance. Treatments that delay progression and provide palliation of symptoms are most likely to improve/maintain HRQoL.

Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1

BackgroundTalazoparib has shown antitumor activity with a manageable safety profile in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA damage response (DDR)/homologous recombination repair (HRR) alterations. ObjectiveTo evaluate patient-reported health-related quality of life (HRQoL) and pain in patients who received talazoparib in the TALAPRO-1 study, with a special interest in patients harboring breast cancer susceptibility gene 1 or 2 (BRCA1/2) mutations. Design, setting, and participantsTALAPRO-1 is a single-arm, phase 2 study in men with mCRPC DDR alterations either directly or indirectly involved in HRR, who previously received one to two taxane-based chemotherapy regimens for advanced prostate cancer and whose mCRPC progressed on one or more novel hormonal agents. Outcome measurements and statistical analysisMen completed the European Quality-of-life Five-dimension Five-level scale (EQ-5D-5L), EQ-5D visual analog scale (VAS), and Brief Pain Inventory—Short Form at predefined time points during the study. The patient-reported outcome (PRO) population included men who completed a baseline and one or more postbaseline assessments before study end. Longitudinal mixed-effect models assuming an unstructured covariance matrix were used to estimate the mean (95% confidence interval [CI]) change from baseline for pain and general health status measurements among all patients and patients with BRCA1/2 mutations. Results and limitationsIn the 97 men in the PRO population treated with talazoparib (BRCA1/2, n = 56), the mean (95% CI) EQ-5D-5L Index improved (all patients, 0.05 [0.01, 0.08]; BRCA1/2 subset, 0.07 [0.03, 0.10]), as did the EQ-5D VAS scores (all patients, 5.42 [2.65, 8.18]; BRCA1/2 subset, 4.74 [1.07, 8.41]). Improvements in the estimated overall change from baseline (95% CI) in the mean worst pain were observed in all patients (–1.08 [–1.52, –0.65]) and the BRCA1/2 subset (–1.15 [–1.67, –0.62]). The probability of not having had experienced deterioration of worst pain by month 12 was 84% for all patients and 83% for the BRCA1/2 subset. ConclusionsIn heavily pretreated men with mCRPC and DDR/HRR alterations, talazoparib was associated with improved HRQoL in all patients and the BRCA1/2 subset. In both patient groups, worst pain improved from baseline and the probability of not experiencing a deterioration in worst pain with talazoparib was high. Patient summaryWe show that talazoparib was associated at least with no change or improvements in health-related quality of life (HRQoL) and pain burden in men with metastatic castration-resistant prostate cancer and DNA damage response/homologous recombination repair gene alterations in the TALAPRO-1 study. These findings in patient-reported HRQoL and pain complement the antitumor activity and tolerability profile of talazoparib.

Health-related quality of life (HRQoL) for patients with advanced/metastatic urothelial carcinoma (UC) enrolled in KEYNOTE-052 who are potentially platinum ineligible.

4561 Background: Frontline cisplatin-based chemotherapy improves survival in patients (pts) with UC, but ̃50% are cisplatin-ineligible owing to poor performance status or comorbidity. The definition of platinum ineligibility is not standardized; hence, treatment decisions are almost solely made by clinical judgment. Pembrolizumab (pembro) showed antitumor activity and manageable toxicity as frontline therapy in 370 cisplatin-ineligible pts in the single arm, phase 2 KEYNOTE-052 trial (NCT02335424). We present effects of pembro on HRQoL of pts in KEYNOTE-052 who were potentially platinum ineligible in this exploratory analysis. Methods: Eligible pts for KEYNOTE-052 were adults with no prior systemic chemotherapy for advanced/metastatic UC, ECOG PS ≤2, and measurable disease per RECIST v1.1 by blinded independent central review. Pembro 200 mg IV was administered Q3W for up to 2 y. Clinical characteristics of frail pts (platinum ineligible) were identified by extensive review of real-world treatment patterns and relevant literature. Consequently, platinum ineligibility was defined as having an ECOG PS ≥2 plus ≥1 of the following: visceral disease, creatinine clearance &lt; 60 mL/min, or age ≥80 y. HRQoL was assessed using the EORTC QLQ-C30 and EQ-5D-3L during the first 4 cycles, then every 2 cycles for 1 year or until treatment discontinuation (whichever occurred first), and at least 30 days after treatment discontinuation. Key end points were change from baseline per the QLQ-C30 global health status (GHS)/QoL score, QLQ-C30 physical functioning subscale, and EQ-5D visual analog scale (VAS). The minimum important difference (MID) was 10 for QLQ-C30 score change (improved: ≥10; stable: –10 to 10; deteriorated: –10 or less); MID for VAS score change was 7 (improved: ≥7; stable: –7 to 7; deteriorated: –7 or less). Results: Median age for 143 pts was 75 y (range, 34-91); 129 pts (90.2%) had visceral disease; 142 (99.3%) had ECOG PS 2; 1 had ECOG PS 3 (enrolled in error). Compliance rate for HRQoL questionnaires was 93.7% at baseline. At the prespecified analysis time of week 9, 77.6% of pts had improved (n = 51) or stable (n = 60) QLQ-C30 GHS/QoL scores, 64.3% had improved (n = 35) or stable (n = 57) QLQ-C30 physical functioning scores, and 62.2% had improved (n = 56) or stable (n = 33) EQ-5D VAS scores. These scores were stable throughout the HRQoL assessment period for pts who continued pembro. Conclusions: In this exploratory analysis, pembro maintained HRQoL for pts with advanced/metastatic UC in KEYNOTE-052 who were potentially platinum-ineligible per the above criteria. Together with the efficacy and safety data from KEYNOTE-052, these data suggest that pembro monotherapy is a valuable treatment option for select pts with advanced UC who are more senior and/or deemed medically frail. Clinical trial information: NCT02335424.

Ferric Carboxymaltose Improves the Quality of Life of Patients with Inflammatory Bowel Disease and Iron Deficiency without Anaemia.

Background: Iron deficiency (ID) without anaemia is a common comorbidity associated with inflammatory bowel disease (IBD) that has a negative impact on health-related quality of life (HRQoL). Methods: This multicentre, prospective, observational study examined the response to, safety of and impact on HRQoL of a single 500 mg dose of intravenous ferric carboxymaltose (FCM) in patients with IBD and ID without anaemia. The diagnostic criteria for ID were low serum ferritin (<30 µg/L in the absence of inflammatory activity or <100 µg/L with inflammation) and transferrin saturation index (TSAT) < 16%. The effect on iron levels and HRQoL, according to the health status questionnaires SF-12v2 and EQ-5D, was evaluated 1 month after FCM infusion in an outpatient setting. Results: Of the 105 patients who received FCM, 98 patients completed the study. After 1 month, a single dose of FCM significantly increased serum ferritin, serum iron and TSAT. Importantly, patients reported fewer ID symptoms and problems on all EQ-5D dimensions. They also had higher EQ-5D visual analogue scale and SF-12v2 scores after treatment. FCM had similar clinical effects on men and women and on patients with Crohn’s disease (n = 66) and ulcerative colitis (n = 32). Conclusion: A single dose of FCM rapidly restored iron parameters and significantly improved patients’ symptoms and HRQoL at 1 month after treatment.

MP21-06 IMPACT OF SEXUAL DYSFUNCTION ON QUALITY OF LIFE IN WOMEN AFTER PELVIC FRACTURE

You have accessJournal of UrologyCME1 May 2022MP21-06 IMPACT OF SEXUAL DYSFUNCTION ON QUALITY OF LIFE IN WOMEN AFTER PELVIC FRACTURE Helen Gambrah, and Niels Vass Johnsen Helen GambrahHelen Gambrah More articles by this author , and Niels Vass JohnsenNiels Vass Johnsen More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002554.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Pelvic neurovascular damage accounts for the well-known association between pelvic fracture and sexual dysfunction. The impact of sexual dysfunction on quality of life has been well-documented but has historically focused on patients with lower urinary tract injuries. These injuries have been shown to be associated with higher rates of SD and therefore are more likely to influence patient-reported quality of life. We hypothesized that the presence of SD following pelvic fracture negatively impacts health-related quality of life (HrQOL) even for patients with no lower urinary tract injuries. METHODS: Women treated for pelvic fracture at a level 1 trauma center between 2012 and 2017 were invited to complete an online survey. Patients with spinal cord injuries, associated lower urinary tract injuries, and isolated acetabular fractures were excluded. Sexual function was assessed using the Female Sexual Function Index (FSFI). HrQOL was evaluated using the visual analog scale (VAS) component of the EuroQol 5 Dimensions Questionnaire (EQ-5D). Inverse probability weighting was utilized to adjust for subject nonresponse. Multivariate regression was performed to evaluate the impact of sexual function on HrQOL. RESULTS: 98 of the 780 potential subjects completed the survey (12.6%). Responders had a mean age at time of injury of 42.2 years (SD 22.4) and median time since injury of 45 months (IQR 30.0, 57.4). After weighting, median FSFI score was 19.1 (IQR 5.5, 27.7), and median EQ-5D VAS score was 71 (IQR 60, 85). Bivariate linear analysis showed that FSFI scores and time since injury were significantly associated with patient-reported HrQOL. A decrease in FSFI scores correlated to a decline in EQ-5D VAS score (β = 0.62, 95% CI 0.30–0.95, p <0.001). Additionally, after adjustment for potential confounders, FSFI, time from injury, and age were all independently associated with HrQOL, with FSFI having the largest effect size (Table 1). CONCLUSIONS: Younger age, increased time since injury, and higher FSFI scores were all independently associated with improved HrQOL scores among women with a history of traumatic pelvic fracture, with FSFI scores as the strongest independent predictor for decreased HrQOL in this patient population. These data highlight the importance of addressing sexual health issues in female pelvic trauma survivors in the post-injury setting. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e329 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Helen Gambrah More articles by this author Niels Vass Johnsen More articles by this author Expand All Advertisement PDF DownloadLoading ...

Impact of Adverse Events on Health-Related Quality of Life After Left Ventricular Assist Device Implantation - An STS INTERMACS Analysis

<h3>Purpose</h3> Our aim was to quantify the impact of pre- and post-operative variables on health-related quality of life (HRQOL) after left ventricular assist device (LVAD) implantation. <h3>Methods</h3> Primary continuous flow durable LVAD implants, with or without concomitant valve surgery, between 2012-2019 in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) were identified. Multivariable modeling using general linear models assessed the impact of baseline patient characteristics, operative factors including device type, and post-implant adverse events (AEs) on HRQOL as assessed by the EQ-5D Visual Analog Scale [(VAS, 0 (worst) to 100 (best health state)] at 6 months and 3 years post-LVAD. Recent AEs were defined as occurring within 60 days prior to follow-up. <h3>Results</h3> Of 22,230 primary LVAD implants, 9,888 patients were alive with complete VAS data at 6 months, and 2,170 were alive with complete VAS data at 3 years follow-up. Median VAS improved from 40 [IQR 10-60] pre-implant to 75 [IQR 60-85] at 6 months and 75 [IQR 60-85] at 3 years (p<0.001). Pre-implant variables, including baseline VAS, were weakly associated with HRQOL, while post-implant AEs had a large negative association. Lower NYHA class at follow-up had a large positive association with HRQOL both at 6 months and 3 years. Recent stroke, recent respiratory failure, and recent renal dysfunction were most strongly associated with impaired HRQOL at 6 months, while recent renal dysfunction, recent respiratory failure, and recent infection were most strongly associated at 3 years (<b>Figure</b>). <h3>Conclusion</h3> AEs following LVAD implantation are most strongly associated with impaired HRQOL in both the early and late follow-up periods. Understanding the impact of AEs on HRQOL may assist clinicians and patients in shared decision making regarding LVAD therapy eligibility and timing of implant. Continued efforts to reduce post-LVAD AE burden are warranted to not only improve survival but also HRQOL.

Missingness of Quality of Life Assessments Before Left Ventricular Assist Device Implant: A Novel Hospital Quality Metric

<h3>Purpose</h3> While improved health-related quality of life (HRQOL) is an important durable left ventricular assist device (LVAD) implant outcome, 50% of HRQOL data are missing in the STS-Intermacs registry. Pre-implant HRQOL missingness may reflect patient and hospital characteristics and thus serve as a novel hospital quality metric. We hypothesized that hospital pre-implant HRQOL missingness independently predicts 90-day outcomes. <h3>Methods</h3> The study cohort included 14,063 patients receiving a primary LVAD (4/2012 - 8/2017) with or without RVAD at 169 hospitals. Patient risk factors of pre-implant HRQOL (using the EQ-5D visual analog scale) missingness were examined by a stepwise logistic model. Direct standardization method was used to calculate hospital adjusted missing rates using a mixed effects logistic model. Hospitals were dichotomized as low/high based on median adjusted missing rates. Cox models, adjusting for patient risk, were used to associate a hospital's pre-implant HRQOL adjusted missing rate with 90-day infection, renal dysfunction and mortality. <h3>Results</h3> Patients with missing pre-implant EQ-5D (47.1% of patients) were younger (mean age: 56.2 vs. 57.9), more often non-White (36.3% vs. 32.0%), with an Intermacs Profile 1 (25.1% vs. 7.3%), compared to those with complete EQ-5D (all p<.0001). Probability of 90-day composite outcome differed by high and low adjusted missing rate hospitals (p<.0001, Figure). A 10% increase in hospital EQ-5D adjusted missingness was significantly associated with 90-day infection (HR: 1.05; 95%CI: 1.03-1.07), infection mortality (HR: 1.09; 95%CI, 1.01-1.18), renal dysfunction (HR: 1.03; 95%CI: 1.004-1.05) but not all-cause mortality (adjusted HR: 1.01; 95%CI, 0.98-1.04). <h3>Conclusion</h3> Higher hospital adjusted pre-implant HRQOL missingness was predictive of higher 90-day infection, infection mortality and renal dysfunction. Hospital pre-implant HRQOL missingness may serve as a novel LVAD quality metric.

Factors Associated with Change in Health-Related Quality of Life from Before to 24 Months After Surgery

<h3>Purpose</h3> We sought to identify factors associated with long-term changes in health-related quality of life (HRQOL) among 3 groups of older patients (pts) with advanced heart failure (HF) undergoing heart transplantation (HT), with or without pre-transplant mechanical circulatory support (MCS), or long-term MCS, if ineligible for HT. <h3>Methods</h3> From 10/1/15-12/31/18, 393 pts (60-80 years) were enrolled from 13 U.S. sites, including 239 pts awaiting HT (118 with and 121 without MCS) and 154 long-term MCS pts. Of these, 151 pts (95 HT pts [34 with MCS and 61 without MCS before HT] and 56 long-term MCS pts) had 24-month follow-up data. The EQ-5D Visual Analog Scale (VAS; 0-100 [worst-best health state]) and KCCQ-12 overall summary score (OSS; 0-100 [poor-excellent health status]) were collected at baseline (closest to surgery) and 24-months. Analyses included ANOVA, paired t-tests, and multivariable linear regression. <h3>Results</h3> Average age at HT or long-term MCS implant (n=151) was 66.8 ±4.5 years, 80% were male, and 81% were white. At baseline, long-term MCS pts, compared with HT pts awaiting HT with MCS and those awaiting HT on medical therapy, had the lowest VAS scores (48.7±20.8 vs 65.9±21.0 vs 51.6±25.4, p=0.002) and KCCQ-12 OSS (37.1±20.9 vs 56.5±25.6 vs 46.4±20.5, p<0.001). HRQOL improved significantly in all 3 groups by 24 months (p<0.001); however, long-term MCS pts, compared with HT pts awaiting HT with MCS and those awaiting HT on medical therapy, still had the lowest VAS scores (70.9±19.7 vs 81.8±14.6 vs 86.2±12.1, p<0.001) and KCCQ-12 OSS (63.3±24.1 vs 85.3±16.0 vs 90.0±14.3, p<0.001). Multivariable models (Table) indicate that baseline HRQOL and undergoing HT, with or without MCS, are the strongest predictors of improvement in HRQOL. <h3>Conclusion</h3> Among pts with advanced HF requiring HT or MCS, improvement in HRQOL was greatest in those undergoing HT with or without MCS pre-HT and those with worse baseline HRQOL. These findings may inform advanced HF pts of anticipated HRQOL outcomes with alternative therapies.

Association of post-stroke-depression and health-related quality of life three months after the stroke event. Results from the Stroke Cohort Augsburg (SCHANA) study

ABSTRACT Approximately one-third of patients with stroke show depressive symptoms. The so-called post-stroke depression (PSD) has a negative influence on mortality as well as physical and mental conditions. The aim of this study was to analyse the association between PSD and health-related quality of life (HRQOL) in patients with stroke. The analysis was based on data of 326 patients from the Stroke Cohort Augsburg (SCHANA Study) collected after the stroke event by interview and three months later using a postal survey. Depressive symptoms were measured with the Patient-Health Questionnaire (PHQ-9), subjective health status with the EuroQol 5D visual analogue scale (EQ-5D VAS), and HRQOL with the Stroke Impact Scale (SIS). Patients with depressive symptoms were compared to those without depressive symptoms in terms of sociodemographic characteristics and scores of the SIS and the EQ-5D VAS. Multiple linear regression models were calculated to investigate the association between PSD and subjective health status and HRQOL. Three months after the stroke, 17.8% of patients had depressive symptoms. Patients with PSD showed significantly worse SIS and EQ-5D VAS scores. In addition, an independent negative linear association between PSD and subjective health status and between PSD and all domains of SIS could be found. The study confirmed that PSD is common in patients with mild stroke and negatively related to all stroke-specific HRQOL domains. The results underline the importance of early screening for PSD in stroke patients since it may hinder a successful rehabilitation.

Factors Associated With Early and Late Post-stroke Fatigue in Patients With Mild Impairment. Results From the Stroke Cohort Study Augsburg.

BackgroundPost-stroke fatigue is a common symptom after stroke. However, studies on the factors associated with early and late fatigue are scarce. The objective of this study was to identify variables associated with early and late fatigue.MethodsIn the German Stroke Cohort Augsburg (SCHANA) study, participants were interviewed during their hospital stay and completed a postal questionnaire 3 and 12 months post-stroke. Fatigue was assessed using the Fatigue Assessement Scale (FAS). In addition, depression was measured by the Patient Health Questionnaire (PHQ-9), general health status by the EQ-5D visual analog scale, and physical activity by the International Physical Activity Questionnaire (IPAQ). Multivariable regression models were used to determine the associations between FAS scores at 3 and 12 months post-stroke and demographic, psychosocial and health-related covariables.ResultsAmong 505 participants, the frequency of fatigue was 31.1% 3 months and 29.1% 12 months post-stroke. Prior stroke (ß = 2.37, p = 0.0076), prior diagnosis of depression (ß = 5.04, p = 0.0001), higher NIHSS (ß = 0.25, p = 0.0360) and higher PHQ-9 scores (ß = 0.55, p < 0.0001) were significantly associated with higher fatigue levels 3 months post-stroke. Additionally, younger age (ß = −0.07, p = 0.0219), a worse rating of general health at baseline (ß = −0.04, p = 0.0287) and low pre-stroke physical activity (ß = −0.0004, p = 0.0089) were significantly associated with higher fatigue levels 12 months after stroke.ConclusionsFatigue is a common and persisting symptom even in patients with mild impairment. Prior depressive disorder and early depressive symptoms were the most relevant predictors of both early and late fatigue.

Surgical and Patient-Reported Outcomes of Delayed Anastomotic Urethroplasty for Male Pelvic Fracture Urethral Injury at a Japanese Referral Center.

We aimed to assess the surgical and patient-reported outcomes of delayed anastomotic urethroplasty (DAU) for pelvic fracture urethral injury (PFUI). We included 211 male patients who underwent DAU for PFUI. DAU success was considered when the urethral lumen was sufficiently large for the passage of a flexible cystoscope, without additional treatment required. The patients completed the lower urinary tract symptoms (LUTS)-related quality of life (QOL) questionnaire (scores: 0, not at all; 1, a little; 2, somewhat; 3, a lot), EuroQol-5 dimensions (EQ-5D), and EQ-5D visual analog scale (EQ-VAS). Postoperative overall satisfaction was evaluated using the following responses: “very satisfied,” “satisfied,” “unsatisfied,” or “very unsatisfied.” DAU was successful in 95.3% cases, with a median postoperative follow-up duration of 48 months. Multivariate logistic regression analysis revealed that “greater blood loss” was an independent predictor of failed urethroplasty. Questionnaire responses were obtained from 80.1% patients. The mean LUTS-related QOL, EQ-5D score and EQ-VAS improved significantly from 2.8, 0.63 and 54.4 at baseline to 0.9, 0.81 and 76.6 postoperatively (p < 0.0001 for all parameters). Moreover, 35.5% and 59.2% of the patients responded being “satisfied” and “very satisfied,” respectively, with their DAU outcomes. DAU not only had a high surgical success rate, but also a significant beneficial effect on both LUTS-related QOL and overall health-related QOL.

Use of perioperative treatment (tx) among patients (pts) undergoing radical resection (RR) for muscle-invasive urothelial cancer (MIUC) in France, Germany, Italy, Spain, the United Kingdom, the United States, Canada, China, and Japan.

467 Background: Cisplatin-based neoadjuvant chemotherapy (NAC) followed by RR is the standard of care in cisplatin-eligible pts with MIUC. Adjuvant chemotherapy (AC) with cisplatin-based tx may be offered to those not given NAC. The unmet need this survey tried to evaluate is the post-RR burden of disease, quality of life (QoL) and perioperative tx patterns among MIUC pts. Methods: Real-world descriptive data were drawn from Adelphi’s MIUC Disease-Specific Programme: A point-in-time survey conducted with clinical/medical oncologists/urologists and their pts in 9 countries between January and June 2021. Physicians completed a survey on their pts’ clinical characteristics and tx patterns, while pts voluntarily completed a series of patient-reported outcome measures. Results: Of 2178 pts (data provided by 320 physicians), 30% received NAC only, 26% received AC only, 38% received no NAC or AC tx, and 6% received both. 1744 pts had initial tumour in the bladder; 35% received NAC only, 24% AC only, 35% no NAC or AC tx, and 6% received both. Of 387 pts with upper-tract urothelial carcinoma (UTUC), 51% received no NAC/AC tx, 35% received AC only, and 12% NAC only. More pts with T3 disease received no NAC/AC tx (36%) or NAC (35%) than AC (24%). Of 734 pts with nodal disease, 36% received NAC only. Of all pts, 60% experienced symptoms at data abstraction: 50% in pts who received NAC only, 71% in pts who received AC only and 82% in pts of those who received both. Pts reported similar EQ-5D-5L utility index scores (mean = 0.86; range: 0.84 [AC only] to 0.89 [NAC only]). Overall, feeling pain (40%) and stress (39%) were the EQ-5D domains with the worst scores. Pts who received AC only reported nominally lower EQ-5D visual analogue scale scores (71.11) compared with pts who received no NAC/AC (73.17) or pts who received NAC only (75.05). EORTC QLQ-C30 Global Health Status scores were 60.0 in pts who received AC only, 64.1 in pts who received NAC only or no NAC/AC, and 66.7 for pts who received both NAC and AC. Conclusions: Nearly 40% of pts remain untreated in either NAC or AC setting in 9 countries. A higher proportion of pts with UTUC go untreated. AC was more frequently used in UTUC vs BC pts; and in pts with Tis. NAC was implemented more frequently in pts T3 disease and in those with N+ disease. Pts who received AC appear to have nominally worse QOL and more symptoms, further demonstrating the need for efficacious adjuvant tx that does not decrease post-RR QoL.[Table: see text]

Rural residence and adherence to continuous positive airway pressure therapy: have we overcome a barrier?

Rural residence and adherence to continuous positive airway pressure therapy: have we overcome a barrier?

Proxy responses regarding quality of life of patients with terminal lung cancer: preliminary results from a prospective observational study

ObjectiveThis prospective study used the EQ-5D utility and Visual Analogue Scale (VAS) scores to analyse the potential usefulness of proxy responses in quality of life assessments of Japanese patients with...

Quality of Life (QoL) Assessment in the Patients Operated with Either Laparoscopic or an Open Aortobifemoral Bypass for Aortoiliac Occlusive Disease (AIOD): 2 Years Results of a Randomized Controlled Trial.

BackgroundQoL assessment within surgical treatment is seldom investigated and sparsely reported in the medical literature. This study aimed to compare QoL in a randomized fashion in the patients treated with either a laparoscopic aortobifemoral bypass (LABFB) or an open aortobifemoral bypass (OABFB) for the treatment of AIOD.Patients and MethodsSeventy-one consecutive patients with AIOD, Trans-Atlantic Inter-Society Consensus II Type D lesions (TASC II, Type D) were randomized to LABFB or OABFB. Thirty-five patients in the LABFB and thirty-six in the OABFB groups were compared for the changes in the QoL, with the short-form health survey (SF-36), EuroQol 5 dimensions (EQ-5D), and EQ-5D visual analog scale (VAS) preoperatively, and postoperatively at 1, 3, 6, 12 and 24 months. Mann–Whitney U-Test and Wilcoxon sign-rank test were used for group comparison. Mixed model analysis was performed to examine the effect of different variables on the QoL.ResultsIn the patients treated with LABFB, physical component score (PCS) and mental component score (MCS) in SF-36 were significantly higher than OABFB, at 1 and 3 months postoperatively. PCS was also significantly higher in the LABFB group than OABFB at 24 months postoperatively. The preoperative QoL scores for both the laparoscopy and the open group were significantly lower than the age-matched general Norwegian population. EQ-5D median scores were significantly higher in the LABFB at all postoperative follow-up time points up to 12 months. The patients in the LABFB group also had a statistically significant increase in EQ-5D VAS compared to OABFB, at 1 and 12 months postoperatively (p = 0.005, and p = 0.037, respectively).ConclusionQoL seems better in patients treated with LABFB than OABFB, particularly during the early months after surgery.

An Updated Analysis of Clinical Outcome Measures Across Patients From the UK Medical Cannabis Registry.

Introduction: There is a growing body of literature supporting the efficacy of cannabis-based medicinal products (CBMPs). Despite an increase in prescribing globally, there is a paucity of high-quality clinical data on the efficacy of CBMPs for many conditions. This study aims to detail the changes in health-related quality of life (HRQoL) and associated clinical safety in patients prescribed CBMPs for any clinical indication from the UK Medical Cannabis Registry (UKMCR). Methods: An uncontrolled prospective case series of the UKMCR was analyzed. Primary outcomes included change from baseline in patient-reported outcome measures collected across all patients (the Generalized Anxiety Disorder Scale [GAD-7], EQ-5D-5L, and Sleep Quality Scale [SQS]) at 1, 3, and 6 months. Secondary outcomes included the self-reported incidence and severity of adverse events. Statistical significance was defined as p<0.050. Results: Three hundred twelve patients were included in the final analysis, with a mean age of 44.8. The most common primary diagnoses were chronic pain of undefined etiology (n=102, 32.7%), neuropathic pain (n=43, 13.8%), and fibromyalgia (n=31, 9.9%). Before enrolment, 112 (35.9%) patients consumed cannabis daily. The median cannabidiol and (-)-trans-Δ9-tetrahydrocannabinol doses prescribed at baseline were 20.0 mg (0.0-510.0 mg) and 3.0 mg (0.0-660.0 mg), respectively. Statistically significant improvements were observed in GAD-7, EQ-5D-5L Index, EQ-5D Visual Analog Scale and SQS scores at 1, 3, and 6 months (p<0.050). There were 94 (30.1%) reported adverse events, of which nausea (n=12, 3.8%), dry mouth (n=10, 3.2%), dizziness (n=7, 2.2%), and somnolence (n=7, 2.2%) were the most common. Conclusion: This study demonstrated CBMP treatment to be associated with a relatively low incidence of severe adverse events in the medium-term. Positive changes following treatment were observed in general, as well as anxiety and sleep-specific, HRQoL outcomes. Randomized controlled trials are still awaited to assess causation; however, real-world evidence can help inform current clinical practice, future trials, and is an important component of pharmacovigilance.