Quality Of Life Metrics Research Articles

Long-Term Quality of Life and Audiometric Outcomes Following Noninvasive Stereotactic Radiosurgery for Acoustic Neuromas

Though microsurgery remains the most common method for management of acoustic neuromas (ANs), stereotactic radiosurgery continues to be a promising alternative. This study assesses long-term quality of life (QOL) outcomes and changes in hearing acuity in patents who have undergone single fraction Gamma Knife stereotactic radiosurgery (GKSRS) for AN.Prospective QOL outcomes were collected and analyzed to include Hearing Handicap Inventory (HHI), Dizziness Handicap Inventory (DHI), Tinnitus Handicap Inventory (THI), and 36-Item Short-Form Survey (SF-36) scores. Likewise, audiometric outcomes including speech discrimination (SD) and pure-tone average (PTA) were assessed. These data points were collected prior to and following GKSRS at regular intervals up to 5 years post-treatment. A mixed effects model for repeated measures was employed to assess QOL data for statistical significance.A total of 235 patients underwent GKSRS for AN at our institution from January 2007 to January 2017. Of these, 130 patients had available QOL and audiometric follow-up data and were included in this study. Median age was 60 y and median follow-up time was 36 mo. Median tumor size was 1.6 cm (0.1 - 3.6 cm), with median tumor volume of 0.552 cm3 (0.028 - 11.31 cm3), while median cochlear mean dose was 2.4 Gy (0 - 9.7 Gy). Baseline mean (median) HHI, DHI, THI, and SF-36 scores were 31.7 (28), 19.3 (12), 18.2 (12), and 70.0 (73.4) respectively. For each of these QOL metrics, mixed effects analysis indicated no statistically significant decline at any time point out to 5 years post-treatment. Indeed, 87% of patients had baseline SD and PTA scores available; 70% had follow-up SD and PTA available. Of these, 59% had baseline serviceable hearing (Gardner-Robertson score of I or II). Serviceable hearing was preserved in 71% of patients at 1 month, 79% at 6 months, 79% at 12 months, 62% at 18 months, 67% at 24 months, and 68% at 36 months.GKSRS provides long-term maintenance of QOL in the treatment of AN. HHI, DHI, THI, and SF-36 scores showed no significant decline up to 5 years post-radiosurgery. Patients with baseline serviceable hearing exhibited adequate hearing preservation.J.S. Lee: None. K.C. Lee: Royalty; Regents of the University of Michigan. Patent/License Fees/Copyright; Regents of the University of Michigan. D. Bojrab: None. P.Y. Chen: Stock; Greater Michigan Gamma Knife (GMGK). J. Jacob: None. I.S. Grills: Greater Michigan Gamma Knife.

Rectal Volume and Quality of Life in Prostate Cancer Patients Receiving Pediococcus-Based Probiotics and Radiation Therapy: A Prospective Randomized Trial

Previous research identified Lactobacillus-based probiotic administration significantly reduced median and percent rectal volumes in prostate cancer (PC) patients undergoing daily radiation therapy (RT). However, Lactobacillus is sensitive to the acidic environment in the stomach. Pediococcus-based probiotics are resistant to pH as low as 1.5. We designed a prospective randomized trial to determine if administration of a Pediococcus-based probiotic therapy is feasible in patients undergoing prostate RT. An exploratory aim was to determine if probiotic therapy decreased rectal volumes throughout RT for PC compared to placebo.This was a single-institution prospective randomized study for men with PC undergoing prostate-only RT. Patients were randomized 1:1 to probiotic (2 gelatin capsules containing 4 × 109 colony-forming units of Pediococcus-based probiotics) or placebo. Administration of study agent was initiated 10 days prior to the start of daily RT. Quality of life (QOL) EPIC - Bowel Domain only surveys were completed at baseline, midway during RT, end of RT, and 1-month follow-up. Toxicities were recorded in accordance with CTCAE v5. Rectal volumes were contoured per the Radiation Therapy Oncology Group guidelines on the initial CT simulation, week 2, and week 6 using quality assurance CTs or cone-beam CTs, and compared using an independent samples Mann-Whitney U-test.Thirty patients were enrolled to the study. Two patients withdrew prior to initiating treatment, leaving 28 patients with evaluable data. Seven patients withdrew from the study for a completion rate of 75%. Of the patients that withdrew, 6 of 7 were on the placebo arm. In the placebo arm, one withdrew before starting the pills and five cited inconvenience as the reason for discontinuation. In the probiotic arm, one participant reported "increased blood pressure" which did not resolve with cessation; this was the only protocol-related toxicity. There were no differences in QOL in bowel function or bother scores between the two groups relative to each patient's baseline. The relative rectal volumes at week 2 (RV2) and 6 (RV6) were not significantly different between probiotic and control arms. RV2 averaged across all patients in each of the two trial arms was 9.9% larger in the probiotic arm compared with controls, RV2p/RV2c = 1.099 with 95% significance limits 0.82 and 1.47, P = 0.51. At 6 weeks, RV6p/RV6c = 0.868, 95% CI 0.654 to 1.152, P = 0.31.While feasible and with rare protocol-related toxicity, compliance with daily capsule administration during conventionally fractionated prostate RT proved difficult, with 25% of patients withdrawing before study completion. Within the limitations of this pilot study, Pediococcus-based probiotic administration did not significantly alter QOL metrics or rectal volumes.

Association of Baseline Health-Related Quality of Life Metrics With Outcome in Localized Prostate Cancer

While health-related quality of life (HR-QoL) outcomes are pivotal in oncology, the prognostic significance of patient-reported HR-QoL metrics is largely undefined in localized prostate cancer (LPCa). In this exploratory analysis, we report the association of baseline HR-QoL metrics with overall survival (OS) and risk of late radiation-induced toxicity in men with LPCa treated with combination of radiotherapy (RT) and androgen deprivation therapy (ADT).This is a secondary analysis of a phase III randomized controlled study conducted in two tertiary cancer centers. LPCa patients with Gleason score ≤7, clinical stage T1b to T3a, and prostate-specific antigen < 30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 months starting 4 months before prostate RT or concurrent and adjuvant ADT for 6 months starting simultaneously with prostate RT. HR-QoL scores were estimated using European Organization for Research and Treatment of Cancer QoL questionnaire. A multi-state Markov model was used to determine the association of baseline HR-QoL metrics with OS and a multilevel multivariable Cox regression to determine the association with incidence of delayed-onset grade ≥3 radiotherapy-related toxicities. To adjust for multiple analyses, P-value < 0.025 was considered as statistically significant. Conditional approach was used to calculate 15-year adjusted OS for patients with and without financial difficulty and patients with and without dyspnea at baseline.Overall, 393 patients with baseline HR-QoL data were included in this analysis - 194 in the neoadjuvant arm and 199 in the adjuvant arm. Baseline financial difficulty (hazard ratio [HR]: 1.020, 95% confidence intervals [CI]:1.010-1.030, P = 0.02), and dyspnea (HR: 1.020, 95% CI:1.003-1.030, P = 0.01) were associated with inferior OS. Adjusted OS for patients with and without financial difficulty at baseline was 15.5% and 45.7%, respectively (P < 0.01). Adjusted OS for patients with and without baseline dyspnea was 21.2% and 46.6%, respectively. Baseline dyspnea was associated with higher incidence of grade ≥3 toxicity (HR: 1.020, 95% CI: 1.010-1.030, P = 0.023).In a cohort of LPCa patients treated with RT and short-term ADT, a 10-point increase in baseline financial difficulty or a 10-point increase in baseline dyspnea was associated with a 20% increased risk of death. With each 10-point increase in baseline dyspnea, we noted an 20% increase in the associated risk of grade ≥3 delayed-onset radiotherapy-related toxicity. These findings underscore the importance of integrating these baseline patient-reported metrics in selecting patients, making informed treatment-decisions, and optimizing overall outcome in men with localized prostate cancer.

Dose and Volume De-Escalation for Elective Nodal Regions in Patients With Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer (OPC) Undergoing Curative-Intent Concurrent Chemoradiation (CCRT)

Several de-escalation strategies for HPV-associated OPC have focused on treatment de-intensification to the gross disease. We propose that by systematically reducing the volume and dose to the elective regions, toxicity can be decreased without compromising tumor control. Here we report our long-term results.Since 2010, we started our systemic de-escalation approach by first reducing the treatment volumes for the node-negative neck. Retropharyngeal, level IB, high level II, and levels IV-V nodal basins were not included in the subclinical target volume. For the node-positive neck, levels IB and V were not covered unless involved. Using this approach, we have observed high control rates. Starting March 2017, we subsequently reduced the dose to all elective regions to 30 Gy in 15 fractions for all patients with HPV-positive OPC undergoing curative CCRT. This is followed by a cone-down to the gross disease with a 3-5 mm margin delivering 40 Gy in 20 fractions. Patients were required to receive concurrent cisplatin or other chemotherapy.From March 2017 to July 2019, 276 consecutive HPV-positive OPC patients underwent CCRT. Median age was 61 (range: 34-87), 90% were male, and 26% had ≥ 15 pack-year of smoking history. Overall, 35% had cT3-4 and 24% had cN2-3 per AJCC 8th Edition. The majority (77%) received high-dose cisplatin and 81% of them had a cumulative dose of 300mg/m2. With a median follow-up of 23 months (range: 1-42), 7 patients (2.5%) developed locoregional recurrence - 6 had disease recurrence in the primary site and/or gross nodes that received 70 Gy and 1 patient had a gross nodal recurrence in the 30 Gy region due to mistargeting. All patients with gross nodal recurrence in the neck were successfully salvaged with surgery. There was no disease recurrence in the subclinical fields receiving 30 Gy or in the omitted radiation fields. Seventeen (6.2%) patients developed distant metastasis. The 2-year locoregional recurrence-free survival was 92.5%, distant metastasis-free survival 90.0%, and overall survival 94.6%. Fifty-six of the 276 patients were also enrolled on an adaptive radiotherapy protocol (NCT03096808) to study modification of the radiation treatment plan during treatment course to account for temporal variations in anatomy, with toxicities and quality-of-life (QoL) metrics evaluated at baseline and follow-up visits. Of the 56 patients on adaptive protocol, 5.8% had feeding tube placement during treatment. No patient had feeding tube dependence at 6 months after radiotherapy. At 2-year follow-up, most of the QoL metrics (pain, social contact, social eating, speech, and swallow) were comparable or superior to baseline measures except for taste and xerostomia.The systematic de-escalation strategy of volume and dose resulted in favorable locoregional control and acute toxicities profile. This regimen can be adapted for treating a wide range of HPV-associated OPC patients undergoing primary CCRT.

Self-reported quality of life as a predictor of mortality in renal cell carcinoma.

This study evaluated the utility of self-reported quality of life (QOL) metrics in predicting mortality among all-comers with renal cell carcinoma (RCC) and externally tested the findings in a registry of patients with small renal masses. The Surveillance, Epidemiology, and End Results-Medicare Health Outcomes Survey (SEER-MHOS) captured QOL metrics composed of mental component summary (MCS) and physical component summary (PCS) scores. Regression models assessed associations of MCS and PCS with all-cause, RCC-specific, and non-RCC-specific mortality. Harrell's concordance statistic (the C-index) and the Akaike information criterion (AIC) determined predictive accuracy and parsimony, respectively. Findings were tested in the prospective Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) registry. In SEER-MHOS, 1494 patients had a median age of 73.4 years and a median follow-up time of 5.6 years. Each additional MCS and PCS point reduced the hazard of all-cause mortality by 1.3% (95% CI, 0.981-0.993; P < .001) and 2.3% (95% CI, 0.971-0.984; P < .001), respectively. Models with QOL metrics demonstrated higher predictive accuracy (C-index, 72.3% vs 70.1%) and parsimony (AIC, 9376.5 vs 9454.5) than models without QOL metrics. QOL metrics exerted a greater effect on non-RCC-specific mortality than RCC-specific mortality. External testing in the DISSRM registry confirmed these findings with similar results for all-cause mortality. Models with self-reported QOL metrics predicted all-cause mortality in patients with RCC with higher accuracy and parsimony than those without QOL metrics. Physical health was a stronger predictor of mortality than mental health. The findings support the incorporation of QOL metrics into prognostic models and patient counseling for RCC.

STERNUM-SPARING LEFT VENTRICULAR ASSIST DEVICE INSERTION REDUCES BLOOD LOSS AND PERIOPERATIVE TRANSFUSIONS: INITIAL CANADIAN EXPERIENCE

<h3>BACKGROUND</h3> In end-stage heart failure, left ventricular assist devices (LVADs) improve survival and quality of life as destination therapy or bridge to transplantation. This sternum-sparing approach avoids the complications of sternotomy and the risk of sternal re-entry for transplantation. There may also be benefits associated with less blood loss and transfusion. Though less-invasive hemisternotomy approaches are well studied, there is a paucity of data in the literature for sternum-sparing BMT. Our center has one of Canada's largest experiences with the BMT approach. Herein, we compared LVAD implantation via BMT with patients who received full median sternotomy or hemisternotomy. <h3>METHODS AND RESULTS</h3> LVAD implantation via bilateral minthoracotomy (image) uses a left anterolateral minithoracotomy for device implantation and right anterior minithoracotomy for aortic anastomosis of the outflow graft. Pericardial tunnelling of the outflow graft retains the pericardium as a barrier between the sternum and heart. A single centre retrospective review was performed at the Foothills Medical Centre (Calgary, Canada) for patients undergoing LVAD insertion from 2012 to 2019. Data was collected from chart review and the Metavision Database. Patients received either BMT (n=11) or sternotomy (full median sternotomy or upper hemisternotomy with left thoracotomy; FS/HS; n=41). Continuous and categorical variables were analyzed by Wilcoxon Rank Sum and Chi-Squared tests respectively. The accompanying table shows patient demographics and perioperative outcomes. Patients receiving BMT were younger and there were no other significant differences in group characteristics related to INTERMACS classification, etiology of heart failure and cardiovascular risk factors. BMT had similar cardiopulmonary bypass times and cross-clamp times to the FS/HS group. There were no differences in stroke or mortality. BMT reduced total intraoperative and CVICU transfusions of packed red blood cells (PRBC), fresh frozen plasma (FFP) and platelets when compared to the full/hemisternotomy group. Additionally, BMT had reduced chest tube outputs in the first 12 hours after LVAD implantation. <h3>CONCLUSION</h3> Outcomes suggest sternum-sparing LVAD implantation is a safe alternative to sternotomy with less post-operative blood loss and transfusion in the early Postoperative period. Less transfusion is particularly valuable in this patient population to reduce antigen-related sensitization prior to transplantation. Additional study is needed to assess potential benefits of this approach for post-operative mobility and patient-reported quality of life metrics.

96: Association of Baseline Health-Related Quality of Life Metrics with Outcome in Localized Prostate Cancer

96: Association of Baseline Health-Related Quality of Life Metrics with Outcome in Localized Prostate Cancer

MP38-18 SELF-REPORTED QUALITY OF LIFE AS A PREDICTOR OF MORTALITY IN BLADDER AND UPPER TRACT MALIGNANCIES

You have accessJournal of UrologyBladder Cancer: Epidemiology & Evaluation I (MP38)1 Sep 2021MP38-18 SELF-REPORTED QUALITY OF LIFE AS A PREDICTOR OF MORTALITY IN BLADDER AND UPPER TRACT MALIGNANCIES Ridwan Alam, Sunil Patel, Max Kates, Nirmish Singla, Trinity Bivalacqua, and Phillip Pierorazio Ridwan AlamRidwan Alam More articles by this author , Sunil PatelSunil Patel More articles by this author , Max KatesMax Kates More articles by this author , Nirmish SinglaNirmish Singla More articles by this author , Trinity BivalacquaTrinity Bivalacqua More articles by this author , and Phillip PierorazioPhillip Pierorazio More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002053.18AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Quality of life (QOL) metrics in cancer patients may provide prognostic value not captured by traditional demographic and disease parameters. We evaluate the utility of self-reported QOL to predict mortality in patients with bladder cancer (BCa) or upper tract urothelial carcinoma (UTUC). METHODS: Using the Surveillance, Epidemiology, and End Results – Medicare Health Outcomes Survey database, patients who completed a QOL questionnaire after the diagnosis of BCa or UTUC were identified. Multivariable regression models assessed associations of mental component summary (MCS) and physical component summary (PCS) scores with all-cause, cancer-specific, and non-cancer-specific mortality. For the competing risks regression, MCS and PCS scores were classified as high (≥50; +) or low (<50; –) based on a population mean score of 50 points. Harrell’s concordance statistic (C-index) and Akaike Information Criteria (AIC) determined predictive accuracy and parsimony, respectively. RESULTS: A total of 1251 patients (1157 BCa, 94 UTUC) with a median follow-up time of 2.3 years (IQR 1.1-4.3) were included. There were 576 deaths, of which 92 were cancer-specific mortalities. There were no significant differences in mortality between the BCa and UTUC groups. Regression analysis demonstrated that each additional MCS and PCS point reduced the hazard of all-cause mortality by 1.2% (95% CI 0.982-0.995, p=0.001) and 2.6% (0.967-0.982, p<0.001), respectively. Models with QOL metrics demonstrated improved predictive accuracy (C-index 71.1% vs 67.6%) and parsimony (AIC 7357.5 vs 7420.8) than models without QOL metrics. On competing risks analysis, patients with low PCS scores were at higher risk of non-cancer-specific mortality compared to their counterparts with high PCS scores (Figure). There was no association between QOL metrics, both mental and physical, and cancer-specific mortality. CONCLUSIONS: Self-reported QOL metrics can be used to predict mortality in BCa and UTUC patients with improved accuracy and parsimony. The incorporation of QOL metrics should be considered in prognostic models and patient counseling for these disease processes. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e701-e702 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ridwan Alam More articles by this author Sunil Patel More articles by this author Max Kates More articles by this author Nirmish Singla More articles by this author Trinity Bivalacqua More articles by this author Phillip Pierorazio More articles by this author Expand All Advertisement Loading ...

Findings from a feasibility study of estradiol for hypogonadal women with cystic fibrosis-related bone disease

BackgroundAdvancements in therapies for patients with cystic fibrosis (CF) have decreased mortality, leading to increased prevalence of chronic complications including bone disease. CF-related bone disease (CFBD) is characterized by low bone mineral density (BMD) and fragility fractures. Estrogen deficiency increases bone resorption, resulting in decreased BMD that can be restored with estrogen replacement. Current CF guidelines recommend treating female hypogonadal patients with CFBD with estrogen replacement, but no prospective study has investigated the effects of estrogen supplementation on CFBD. Estrogen is known to modulate inflammatory markers and autoimmune diseases.We proposed to test the hypothesis that estrogen status plays a critical role in optimizing bone health, modulating inflammation, preserving lung function, and maximizing quality of life in premenopausal women with CF.MethodsWe planned a randomized, placebo-controlled, investigator- and patient-blinded, pilot trial with two parallel arms. Eligible subjects were women with CF 18–50 years old with hypogonadism and low BMD who were not taking systemic glucocorticoids, had not had a prior transplant, and did not have contraindications to oral estradiol. Subjects would be block randomized to receive oral estradiol or placebo for 6 months. The primary outcome was feasibility metrics. Secondary outcomes included relative changes in estradiol, bone turnover markers, lung function, inflammatory markers, and quality of life metrics. The study was funded through departmental funds.ResultsOf 233 subjects screened, 86 subjects were women with CF 18–50 years old and none were eligible for participation. Most subjects were excluded due to absent DXA report (24%), normal BMD (22%), or use of systemic estrogen (16%). Due to difficulty recruiting the planned 52 subjects, the trial was closed for recruitment and no subjects were randomized.ConclusionThis study was designed to investigate the feasibility of a safety and efficacy trial of estrogen therapy for women with CF. Unfortunately, due to eligibility criteria, the study was unable to recruit subjects. This feasibility study highlights the need for improved BMD screening in young women with CF. Future study designs may require the incorporation of a screening DXA as part of subject recruitment.Trial registrationThe study was registered on ClinicalTrials.gov (NCT03724955).

Anemia in Cardiovascular Disease: Marker of Disease Severity or Disease-modifying Therapeutic Target?

In this review paper, we examine the latest evidence regarding the use of iron supplementation, erythropoiesis-stimulating agents (ESAs), and blood transfusions as therapeutic targets for anemia to mitigate morbidity and mortality in patients with cardiovascular disease. Intravenous ferric carboxymaltose (FC) injections in heart failure (HF) have resulted in improved self-reported patient symptoms; higher exercise capacity, as measured by 6-min walk test distance in anemic patients; and lower re-hospitalization rates in iron deficient patients. Darbepoetin alfa has shown evidence of improved Kansas City Cardiomyopathy Questionnaire scores. No mortality benefits have been noted thus far with FC injections or darbepoetin in HF, with an increase in adverse events with darbepoetin. Aggressive transfusions (Hg < 10g/dL) are not associated with improved outcomes in cardiovascular disease. Quality of life metrics, rather than mortality, appear to improve with IV FC and ESA use in HF. More studies are required to see if these treatments have a role in coronary artery disease. Current evidence suggests that anemia is a marker of underlying disease severity, with a limited role in disease modification. Further studies are required to solidify our understanding of this topic.

Glasgow Benefit Inventory in Cochlear Implantation: A Reliable Though Ancillary Quality of Life Metric.

The Glasgow Benefit Inventory (GBI) is a health-related quality of life instrument used to detect changes in health status following otolaryngologic interventions. Despite its use in cochlear implant literature, assessment of utility, reliability, and validity of GBI in an adult cochlear implants (CI) patient population has yet to be performed. Retrospective case series. Academic, tertiary referral center. Postlingually deafened, adult CI patients with at least 1 year of device use. Five hundred fifty-two patients were administered GBI questionnaires at least 1 year following CI activation during follow-up visits. GBI total and subscale scoring were compared to either the Hearing Handicap Inventory for Adults or Hearing Handicap Inventory for the Elderly. Moreover, a factor analysis and Cronbach's alpha were performed to determine GBI validity and internal reliability, respectively. The average overall GBI score was 38.6 ± 21.7. This was weakly correlated to the reduction in Hearing Handicap Inventory for Adults/Hearing Handicap Inventory for the Elderly (τb = 0.282, p < 0.05). High factor loading with minimal cross-loading was noted on a three-factor solution, which emulated the original GBI development. Internal reliability was acceptable for the general benefit (α = 0.913) and social support subclasses (α = 0.706), whereas physical health's was low (α = 0.643). Although GBI possesses adequate convergent and discriminant validity with acceptable reliability, its routine use to capture CI-specific health-related changes should not supersede validated CI-specific QoL instruments.

Operative Versus Nonoperative Treatment of Z-Type Comminuted Clavicle Fractures in Adolescents: A Substratified Cohort Analysis

Purpose: There has been a recent shift towards operative management of mid-shaft clavicle fractures in adults and adolescents. This has been largely based on studies in the adult population that showed reduced rates of nonunion, symptomatic malunion and better short-term functional outcomes. For injuries with a comminuted “Z-type” fracture pattern, characterized by vertical positioning of a segmental fragment, it is commonly accepted to treat surgically due to concerns about healing and bony prominence. The purpose of this study was to assess the clinical, radiographic, and patient-reported outcome measures (PROs) in adolescents with comminuted Z-type mid-shaft clavicle fractures by comparing an operative and nonoperative cohort.&#x0D; Methods: Patients aged 10 to 18 years treated for a diaphyseal clavicle fracture between August 2013 and February 2016 at one of eight geographically diverse pediatric centers were screened and enrolled at the time of injury. Inclusion criteria were a comminuted Z-type fragment ≥1cm in size, with &gt;35 degrees of angulation relative to the long axis of the clavicle, and &gt;100% fracture displacement at time of presentation. Clinical course, complications, validated PROs, quality of life metrics, and satisfaction scores were analyzed and compared between the operative (Op) and nonoperative (NonOp) cohorts.&#x0D; Results: Eighty-two patients (37 NonOp, 45 Op) were included, 60 (73%) of whom provided 2-year PROs with similar response rates between treatment cohorts. There were no significant differences in demographics or fracture characteristics in the two cohorts other than fracture shortening being greater in the operative cohort (mean 29mm) compared to the nonoperative cohort (mean 23mm, p=0.01). This confounder was controlled for in both regression analysis and propensity score matching. There was no statistically significant difference in the rates of nonunion (none), delayed union (Op 2%, NonOp 0%, p=1.0), symptomatic malunion (Op 0%, NonOp 3%, p=0.4), refracture (Op 4%, NonOp 3%, p=1.0), unexpected surgery (Op 11% vs. NonOp 5%, p=0.45), or clinically significant complications (Op 16%, NonOp 5%, p=0.17) between cohorts. There were no differences in PROs (Table 1), even when controlling for fracture shortening.&#x0D; Conclusions: Z-type mid-shaft clavicle fractures are one of the most severe fracture patterns seen in adolescent shoulders. Yet, in this comparative investigation of 2-year PROs and complications, surgery appears to offer no benefit over nonoperative management. &#x0D; Significance: The comparable natural histories between this study’s operative and nonoperative cohorts are critical for surgeons and their adolescent patients to understand when deciding appropriate management, particularly when reviewing what are often very concerning appearing initial radiographs.

Clinical impact of MultiPoint pacing in responders to cardiac resynchronization therapy.

Cardiac resynchronization therapy demonstrated benefits in heart failure. However, only 60-70% are responders and only 22% are super-responders. MultiPoint pacing (MPP) improves structural remodeling, but data in responder patients is scarce. A prospective, randomized study of the efficacy of MPP was conducted in patients who were CRT responders after 6 months of bi-ventricular (BiV) therapy. At 6 months, responder patients (LV end-systolic volume [LVESV] reduction ≥15%) were randomized to either continued BiV therapy or to MPP programmed with wide anatomical separation ≥30mm, and followed until 12 months. Efficacy was determined by 6-12 month changes in LVESV and LV ejection fraction (LVEF). Evaluations of super-responder rate (LVESV reduction ≥30%) and quality of life (NYHA, EQ-5D, MLHFQ) were also performed. From February 2017 to February 2019, 73 CRTs with Quartet LV leads were implanted (42.9% female, 65.7 ± 10.8 years old, 79.5% dilated cardiomyopathy). At 6 months, 74.2% responded to BiV and were randomized to BiV (n=25) or MPP (n=24). MPP versus BiV delivered greater LVESV improvement (8.3% decrease in MPP vs. 10.3% increase in BiV patients, p=.047), greater increase in LVEF (7.7%vs. 1.8%, p=.008), and higher 0-12 month super-responder rate (86.4%vs. 56.0%, p=.027). More MPP vs. BiV patients experienced an improvement in NYHA (84.6%vs. 50.0%, p=.047) and EQ-5D (94.4%vs. 54.0%, p=.006). MPP with wide anatomical spacing in CRT responder patients resulted in improved LV reverse remodeling with higher rates of super-responders, and better quality of life metrics.

The impact of cognitive rehabilitation on quality of life in multiple sclerosis: A pilot study.

BackgroundCognitive impairment in people with multiple sclerosis (pwMS) negatively impacts daily function and quality of life (QoL). Prior studies of cognitive rehabilitation in pwMS have shown limited benefit but many focused on cognitive function scores rather than QoL measures. Studies using QoL metrics primarily evaluated group cognitive rehabilitation, which may be less appropriate due to variable cognitive profiles in pwMS. This study assesses the impact of an individualized cognitive rehabilitation approach on QoL in MS.MethodsWe performed a retrospective chart review of NeuroQoL assessments done by pwMS (n = 12, mean age 47.9 ± 4.0 years, 75% female, 100% White, 75% RRMS) before and after participation in an individualized compensatory cognitive program. We used a comparison group of pwMS who were candidates for the program but did not participate (n = 9, mean age 48.9 ± 4.4 years, 88.9% female, 100% White, 66.7% RRMS)ResultsPwMS who participated in the rehabilitation program saw improvements in Sleep Disturbance (50.5 from 55.5, p = 0.005), Fatigue (52.5 from 57.0, p = 0.024), Anxiety (49.8 from 55.4, p = 0.011), and Cognitive Function (39.3 from 36.7, p = 0.049).ConclusionsIndividualized compensatory cognitive rehabilitation appears effective for improving QoL measures in pwMS with cognitive complaints, supporting the need for further randomized controlled prospective analysis of this intervention.

PCN208 Association of Quality of Life with Oncology Medication Adherence in Cancer Patients on the Service of a Specialty Pharmacy

Specialty pharmacy drugs (SP-D) are high-cost and for the treatment of complex conditions, e.g., cancer (O). High medication adherence and quality of life (QoL) contribute to desired treatment outcomes. SP Medication Therapy Management (SPMTM) contributes to optimal QoL and adherence; therefore, the objective is to compare adherence to oral O-SP-D with QoL metrics reported by O patients who participated in SPMTM before and after Start of Care (SOC).

PROSPER: Phase III RandOmized Study Comparing PERioperative nivolumab versus observation in patients with renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN EA8143).

TPS4596 Background: There is no standard adjuvant systemic therapy that increases overall survival (OS) over surgery alone for non-metastatic RCC. Anti-PD-1 nivolumab (nivo) improves OS in metastatic RCC and is well tolerated. In mouse models, priming the immune system prior to surgery with anti-PD-1 results in superior OS compared to adjuvant dosing. Remarkable pathologic responses have been seen with neoadjuvant PD-1 in multiple ph 2 studies in bladder, lung and breast cancers. Phase 2 neoadjuvant RCC trials of nivo show preliminary feasibility and safety with no surgical delays. PROSPER RCC seeks to improve clinical outcomes by priming the immune system with neoadjuvant nivo prior to nephrectomy followed by continued immune system engagement with adjuvant blockade in patients (pts) with high risk RCC compared to standard of care surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is accruing pts with clinical stage ≥T2 or TanyN+ RCC of any histology planned for radical or partial nephrectomy. Select oligometastatic disease is permitted if the pt can be rendered ‘no evidence of disease’ within 12 weeks of nephrectomy (≤3 metastases; no brain, bone or liver). In the investigational arm, nivo is administered 480mg IV q4 weeks with 1 dose prior to surgery followed by 9 adjuvant doses. The control arm is nephrectomy followed by standard of care surveillance. There is no placebo. Baseline tumor biopsy is required only in the nivo arm but encouraged in both. Randomized pts are stratified by clinical T stage, node positivity, and M stage. 805 pts provide 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival at 5 years assuming the ASSURE historical control of ̃56% to 70% (HR = 0.70). The study is powered to evaluate a significant increase in OS (HR 0.67). Critical perioperative therapy considerations such as safety, feasibility, and quality of life metrics are integrated. PROSPER RCC embeds a wealth of translational studies to examine the contribution of the baseline immune milieu and neoadjuvant priming with anti-PD-1 on clinical outcomes. As of February 10, 2021, 704 patients have been enrolled (N = 805). Clinical trial information: NCT03055013.

Cancer-related outcomes in oncology patients admitted to physical rehabilitation facilities.

e18643 Background: Admission to a physical rehabilitation facility (RF) can improve mobility and quality of life metrics in cancer patients, however, limited data exist on how these admissions impact cancer-related outcomes. We hypothesized that admissions to a RF following hospitalization delays cancer-directed treatment and increases mortality compared to those who are discharged home. Methods: A retrospective chart review identified oncology patients who were being treated with either intravenous or subcutaneous cancer-directed therapy between 2010-2020 and admitted to either a RF or home following hospitalization. Exclusion criteria were patients not on active cancer-directed treatment or going to hospice. Comparisons of RF vs. home were made using a chi-square test or Fisher’s exact test for categorical outcomes. Median days to next chemotherapy for each group were assessed with Kaplan-Meier/Product-Limit Estimates with a corresponding 95% confidence interval. Results: Of 189 patients, 24 were admitted to a RF and 165 went home. The median age of the study population was 65.6 years, with more males (66.7%) admitted to a RF vs. discharged home (49.7%), and both groups having &gt;50% advanced stage cancer; primarily GI malignancies (25.9%) (Table). There was a statistically significant increase in the percent of patients who experienced delays in the time to their next anticipated chemotherapy date in the RF group vs. home (70.8% vs. 30.3%, P&lt;0.0001), as well as median days to next chemotherapy (38.5 vs. 22, P&lt;0.007). 30-day readmission rates were higher in patients at a RF vs. home (50% vs 29%, P&lt;0.04). There were no significant differences in mortality comparing RF vs. home at 3, 6, or 12 months from the index inpatient hospitalization. Conclusions: Hospitalized oncology patients who were admitted to a RF had significant delays in cancer-directed therapy. Despite the smaller sample size of patients in a RF, their 30-day readmission rates were higher, suggesting a need to carefully select patients who can afford delays in cancer treatment.[Table: see text]

Patient-reported Quality of Life following Stereotactic Body Radiation Therapy for Primary Kidney Cancer – Results from a Prospective Cohort Study

AimsWe report on the first prospective series of patient-reported quality of life (QoL) following stereotactic body radiation therapy (SBRT) for primary kidney cancer. Materials and methodsPatients were treated on a multi-institutional prospective cohort study with 30–42 Gy SBRT in three or five fractions. QoL assessments were carried out using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-15 Palliative (EORTC-QLQ-C15-PAL), the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FACT FKSI-19) and the EuroQol-5D-3L tools at baseline, 1 week, and 1, 3 and 6 months post-treatment. QoL over time was analysed using linear mixed modelling, pairwise and anchor-based analyses. ResultsTwenty-eight patients were included. No significant reduction in any QoL metric was observed on repeated measures. However, a trend to reduced EORTC global QoL and fatigue was observed at 1 week, with improvement over time in other symptom scores such as pain, appetite and nausea. On pairwise analysis, there were statistically significant reductions in global QoL at 1 week (with subsequent recovery) and dyspnoea at 6 months post-SBRT. Trends to improved pain, appetite and nausea were observed following SBRT. Less than half of patients reported stable or better EORTC global QoL at 1 week. For all other QoL and symptom scales, most patients had reported stable or better scores at all times, with a slight proportional improvement in emotional functioning, nausea, fatigue, pain and appetite, and a slight worsening of physical functioning and dyspnoea over time. ConclusionsSBRT results in well-preserved QoL in the weeks to months following treatment for primary kidney cancer.

P05.13 Central vs Peripheral Thoracic Malignancies Treated with SBRT: Early Outcomes of a Prospective Quality of Life Study

Thoracic malignancies in close proximity to central mediastinal structures are known to have a higher rate of treatment-related toxicity following stereotactic body radiation therapy (SBRT). Intrinsic damage secondary to tumor invasion may contribute to this increased toxicity and could be identified by pretreatment quality of life metrics. The appropriate dose fractionation schedule as well as daily treatment schedule that may mitigate the aforementioned central toxicity remains nebulous. We reviewed patients on a prospective trial assessing quality of life before and after SBRT and stratified based on central versus peripheral anatomical location. In this single institutional study, patients were enrolled on a prospective quality of life trial approved by the local Institutional Review Board. All patients were evaluated by a multidisciplinary thoracic oncology team and were diagnosed with thoracic malignancy amenable to stereotactic body radiation therapy delivered in 5 or fewer treatment fractions on an every other day schedule. Central tumors were defined as those within 2 cm of central mediastinal structures including the proximal bronchial tree. Patients underwent pre-and post-treatment quality of life questionnaires including the prospectively validated EORTC Quality of Life Core questionnaire (QLQ-C30 version 3) and Supplemental Lung Cancer module questionnaire (QLQ-LC13). Baseline differences between groups were analyzed using the Mann-Whitney U and Chi-squared tests. Score comparisons for EORTC questionnaires pre- and post- SBRT were conducted using the Wilcoxon signed-rank test. All statistics were performed in SPSS, version 24. A total of 31 patients from February 2018 to February 2020 were enrolled with a median age of 70 (59-90) years. The majority of patients had an ECOG of 1 (n = 15) and the most common histology was adenocarcinoma (n = 17). A total of 13 patients were found to have central lung tumors. There were no significant pretreatment differences in age, performance status, gender or the predefined EORTC questionnaire-specific subcategorized functional, quality of life, or symptom domains between patients diagnosed with central versus peripheral tumors. Following SBRT, there were notable, statistically significant improvements in the Emotional functioning (EF) domain (pre- and post- treatment median: 61.5 and 91.7, respectively, z=-2.01, p=.044) and the Cognitive functioning (CF) domain (pre- and post- treatment median: 75.0 and 91.7, respectively z=-2.06, p=.039) in patients treated for central lung tumors. Similar improvements were not observed in patients treated for peripheral lung tumors. There were no significant changes in any other functional, symptom, or quality of life domain following treatment for either group. Pretreatment EORTC quality of life metrics did not demonstrate significant differences in patients diagnosed with central versus peripheral thoracic malignancies in our prospective cohort. However, patients with central lung tumors experienced significant improvements in their EF and CF domains following SBRT. These findings suggest patients with central lung tumors may experience greater psychological distress from their disease independent of self-reported physical symptom burden.

The effect of adherence on antihypertensive therapy plans in patients with diabetes

Patient adherence to a medication plan may significantly impact the benefits received by therapy. Thus, considering patient adherence to antihypertensive medication therapy in patients with diabetes, we investigate the impacts of adherence levels on patient health outcomes using a finite horizon, discounted Markov decision process. Health states are based on varying systolic blood pressure levels, cardiovascular complications, adherence levels, and the patient’s current hypertension medications. We model patient transitions through these health states by combining various models from the literature. The model maximizes the expected quality-adjusted life years (QALY). Experimentation on varying levels of patient adherence to medication plans emphasizes the importance of adherence to medication plans with respect to a quality of life metric. Furthermore, sensitivity analysis of model factors finds that smoking as an internal factor, and model parameters as external factors highly influence health outcomes. Furthermore, when patients maintain a higher than average adherence level, they will be able to noticeably increase their expected QALYs.