Health-related Quality Of Life Metrics Research Articles

Health-related quality of life among patients with multiple myeloma treated with CAR-T therapy.

e20040 Background: The regulatory approvals in myeloma were predominantly based on the safety and efficacy of the antimyeloma therapies. Health-related quality of life (HRQOL) metrics have not routinely been incorporated into these studies, nor were they a requirement for approval, which explains the dearth of HRQOL studies in myeloma. Recent approvals of chimeric antigen receptor T-cell (CAR-T) therapy targeting the B-cell maturation antigen were no different. While improved clinical outcomes in myeloma led to the FDA and EMA approvals, the CAR-T effects on HRQOL are not well described. Methods: We conducted a cross-sectional observational pilot study to evaluate HRQOL among patients that received CAR-T. Inclusion criteria were age >/= 18 years with a diagnosis of myeloma, had been treated with an autologous CAR-T a minimum of 56 days prior to survey date and had not yet experienced progression as defined by the IMWG criteria. HRQOL measurements were obtained using validated tool, self-administered FACT-MM questionnaire post-CAR-T infusion. The primary endpoint measurement was the FACT-MM composite score. Associations between FACT-MM scores and predictors were analyzed using nonparametric tests. FACT-MM and subscores were analyzed as continuous and dichotomous outcomes. Results: Between December 2021 and July 2022, 22 patients were enrolled (male: 54.55%, white: 54.55%). The median age of patients was 64 (range, 43-86) and the median time to enroll on the study from diagnosis is 6.5 years (3.5-17). Median FACT-MM score was 137.5 (IQR: 18.5) out of a maximum possible score of 164. The median trial outcome index (TOI) which is the sum of the physical and functional well-being (PWB and FWB), a predictor for physical and functional outcomes from treatment (FACIT) was 95 (IQR: 17) out of maximum possible 112. Other descriptive variables of interest were shown in the table. Differences in TOI were found between races (White, African American (AA), & Asian p = 0.04). In our sample, AA and Asian subjects had higher median TOI, therefore race should not be considered to have a negative impact on clinical trial success. Subjects with a history of Gilbert’s syndrome (2 vs 20), reported higher overall FACT-MM scores (p = p=0.04), PWB (p=0.03) and pain-related HRQOL (p = 0.04). Interestingly, we did not find that HRQOL differed by patients that had evidence of CRS or ICANS during CAR-T therapy, or by age, R-ISS, CCI, presence of EMD or prior lines of therapy (LOT). Conclusions: Patients treated with CAR-T have reported high HRQOL metrics at least 2 months out from infusion. Age, RISS, CCI, prior LOT did not impact the HRQOL and may not be the sole criteria used for decision making whether or not to offer CAR-T. [Table: see text]

A Hierarchical Approach to Realignment Strategies in Adult Cervical Deformity Surgery.

Retrospective cohort study. Construct an individualized cervical realignment strategy based on patient parameters at the presentation that results in superior 2-year health-related quality of life metrics and decreased rates of junctional failure and reoperation following adult cervical deformity surgery. Research has previously focused on adult cervical deformity realignment thresholds for maximizing clinical outcomes while minimizing complications. However, realignment strategies may differ based on patient presentation and clinical characteristics. We included adult cervical deformity patients with 2-year data. The optimal outcome was defined as meeting good clinical outcomes without distal junctional failure or reoperation. Radiographic parameters assessed included C2 Slope, C2-C7, McGregor's slope, TS-CL, cSVA, T1 slope, and preoperative lowest-instrumented vertebra (LIV) inclination angle. Conditional inference trees were used to establish thresholds for each parameter based on achieving the optimal outcome. Analysis of Covariance and multivariable logistic regression analysis, controlling for age, comorbidities, baseline deformity and disability, and surgical factors, assessed outcome rates for the hierarchical approach within each deformity group. One hundred twenty-seven patients were included. After correction, there was a significant difference in meeting the optimal outcome when correcting the C2 slope below 10 degrees (85% vs. 34%, P <0.001), along with lower rates of distal junctional failure (DJF) (7% vs. 42%, P <0.001). Next, after isolating patients below the C2 slope threshold, the selection of LIV with an inclination between 0 and 40 degrees demonstrated lower rates of distal junctional kyphosis and higher odds of meeting optimal outcome(OR: 4.2, P =0.011). The best third step was the correction of cSVA below 35mm. This hierarchical approach (11% of the cohort) led to significantly lower rates of DJF (0% vs. 15%, P <0.007), reoperation (8% vs. 28%, P <0.001), and higher rates of meeting optimal outcome (93% vs. 36%, P <0.001) when controlling for age, comorbidities, and baseline deformity and disability. Our results indicate that the correction of C2 slope should be prioritized during cervical deformity surgery, with the selection of a stable LIV and correction of cervical SVA below the idealized threshold. Among the numerous radiographic parameters considered during preoperative planning for cervical deformity correction, our determinations help surgeons prioritize those realignment strategies that maximize the health-related quality of life outcomes and minimize complications. Level-III.

Patient-Reported Outcomes Following Anterior and Posterior Surgical Approaches for Multilevel Cervical Myelopathy.

Retrospective cohort. To compare health-related quality of life (HRQoL) outcomes between approach techniques for the treatment of multilevel degenerative cervical myelopathy (DCM). Both anterior and posterior approaches for the surgical treatment of cervical myelopathy are successful techniques in the treatment of myelopathy. However, the optimal treatment has yet to be determined, especially for multilevel disease, as the different approaches have separate complication profiles and potentially different impacts on HRQoL metrics. Retrospective review of a prospectively managed single institution database of patient-reported outcome measures after 3 and 4-level anterior cervical discectomy and fusion (ACDF) and posterior cervical decompression and fusion (PCDF) for DCM. The electronic medical record was reviewed for patient baseline characteristics and surgical outcomes whereas preoperative radiographs were analyzed for baseline cervical lordosis and sagittal balance. Bivariate and multivariate statistical analyses were performed to compare the two groups. We identified 153 patients treated by ACDF and 43 patients treated by PCDF. Patients in the ACDF cohort were younger (60.1 ± 9.8 vs . 65.8 ± 6.9 yr; P < 0.001), had a lower overall comorbidity burden (Charlson Comorbidity Index: 2.25 ± 1.61 vs . 3.07 ± 1.64; P = 0.002), and were more likely to have a 3-level fusion (79.7% vs . 30.2%; P < 0.001), myeloradiculopathy (42.5% vs . 23.3%; P = 0.034), and cervical kyphosis (25.7% vs . 7.69%; P = 0.027). Patients undergoing an ACDF had significantly more improvement in their neck disability index after surgery (-14.28 vs . -3.02; P = 0.001), and this relationship was maintained on multivariate analysis with PCDF being independently associated with a worse neck disability index (+8.83; P = 0.025). Patients undergoing an ACDF also experienced more improvement in visual analog score neck pain after surgery (-2.94 vs . -1.47; P = 0.025) by bivariate analysis. Our data suggest that patients undergoing an ACDF or PCDF for multilevel DCM have similar outcomes after surgery.

Comorbidity and health-related quality of life in people with a chronic medical condition in randomised clinical trials: An individual participant data meta-analysis.

Health-related quality of life metrics evaluate treatments in ways that matter to patients, so are often included in randomised clinical trials (hereafter trials). Multimorbidity, where individuals have 2 or more conditions, is negatively associated with quality of life. However, whether multimorbidity predicts change over time or modifies treatment effects for quality of life is unknown. Therefore, clinicians and guideline developers are uncertain about the applicability of trial findings to people with multimorbidity. We examined whether comorbidity count (higher counts indicating greater multimorbidity) (i) is associated with quality of life at baseline; (ii) predicts change in quality of life over time; and/or (iii) modifies treatment effects on quality of life. Included trials were registered on the United States trials registry for selected index medical conditions and drug classes, phase 2/3, 3 or 4, had ≥300 participants, a nonrestrictive upper age limit, and were available on 1 of 2 trial repositories on 21 November 2016 and 18 May 2018, respectively. Of 124 meeting these criteria, 56 trials (33,421 participants, 16 index conditions, and 23 drug classes) collected a generic quality of life outcome measure (35 EuroQol-5 dimension (EQ-5D), 31 36-item short form survey (SF-36) with 10 collecting both). Blinding and completeness of follow up were examined for each trial. Using trials where individual participant data (IPD) was available from 2 repositories, a comorbidity count was calculated from medical history and/or prescriptions data. Linear regressions were fitted for the association between comorbidity count and (i) quality of life at baseline; (ii) change in quality of life during trial follow up; and (iii) treatment effects on quality of life. These results were then combined in Bayesian linear models. Posterior samples were summarised via the mean, 2.5th and 97.5th percentiles as credible intervals (95% CI) and via the proportion with values less than 0 as the probability (PBayes) of a negative association. All results are in standardised units (obtained by dividing the EQ-5D/SF-36 estimates by published population standard deviations). Per additional comorbidity, adjusting for age and sex, across all index conditions and treatment comparisons, comorbidity count was associated with lower quality of life at baseline and with a decline in quality of life over time (EQ-5D -0.02 [95% CI -0.03 to -0.01], PBayes > 0.999). Associations were similar, but with wider 95% CIs crossing the null for SF-36-PCS and SF-36-MCS (-0.05 [-0.10 to 0.01], PBayes = 0.956 and -0.05 [-0.10 to 0.01], PBayes = 0.966, respectively). Importantly, there was no evidence of any interaction between comorbidity count and treatment efficacy for either EQ-5D or SF-36 (EQ-5D -0.0035 [95% CI -0.0153 to -0.0065], PBayes = 0.746; SF-36-MCS (-0.0111 [95% CI -0.0647 to 0.0416], PBayes = 0.70 and SF-36-PCS -0.0092 [95% CI -0.0758 to 0.0476], PBayes = 0.631. Treatment effects on quality of life did not differ by multimorbidity (measured via a comorbidity count) at baseline-for the medical conditions studied, types and severity of comorbidities and level of quality of life at baseline, suggesting that evidence from clinical trials is likely to be applicable to settings with (at least modestly) higher levels of comorbidity. A prespecified protocol was registered on PROSPERO (CRD42018048202).

Peer Support in Rheumatic Diseases: A Narrative Literature Review.

Rheumatic diseases are a group of chronic conditions that are associated with significant morbidity, impaired physical function, psychosocial stress, and cost to the healthcare system. Peer support interventions have been shown to have a positive impact on health outcomes in several chronic conditions, but no review has specifically assessed the impact of peer support on rheumatic conditions. The aim of this narrative literature review was to understand how peer support has been applied in the field of rheumatology, with a specific focus on the impact of observational and randomized studies of direct peer support interventions on various outcome measures across rheumatic conditions. We also examined studies exploring patient attitudes and preferences toward peer support. The majority of studies included focused on peer support in rheumatoid arthritis and systemic lupus erythematosus. Generally, patients across the spectrum of rheumatic disease perceive peer support as a useful tool. Peer support interventions, while highly variable, were generally associated with positive impacts on health-related quality of life metrics (both perceived and measured), although these differences were not always statistically significant. Important limitations include variability in study design, selection bias among study participants, and short follow-up periods across most peer support interventions.

Clinical Improvements in Myelopathy Result in Improved Patient-Reported Outcomes Following Anterior Cervical Discectomy and Fusion.

Retrospective cohort study. To determine if myelopathy severity predicted the magnitude of improvement in health-related quality of life metrics following anterior cervical discectomy and fusion (ACDF). Surgery for myelopathy is primarily performed to halt disease progression. However, it is still controversial if these patients can expect significant health-related quality-of life improvements following ACDF. We explore the relationship between modified Japanese Orthopaedic Association (mJOA) improvements and its effect on other health-related quality-of life metrics. Patients undergoing ACDF for myelopathy were grouped based on preoperative mJOA scores into mild (15-17), moderate (12-14), and severe (<12) groups. Patients were subsequently categorized based on if they attained the minimum clinically detectable improvement (MCID) threshold for mJOA. Multivariate linear regression was performed to determine the magnitude of improvement in ∆patient-reported outcome measures. A total of 374 patients were identified for inclusion. Of those, 169 (45.2%) had mild myelopathy, 125 (33.4%) had moderate, and 80 (21.4%) had severe myelopathy. Only the moderate and severe groups had significant improvements in mJOA following surgery (mild: P =0.073, moderate: P <0.001, severe: P <0.001). There were no significant differences in the magnitude of improvement for any patient-reported outcome measure based on myelopathy severity, except for mJOA (mild: 0.27, moderate: 1.88, severe: 3.91; P <0.001). Patients meeting the MCID for mJOA had better ∆Short-Form 12 Mental Component Score (3.29 vs. -0.21, P =0.007), ∆Short-Form 12 Physical Component Score (6.82 vs. 1.96, P <0.001), ∆Visual Analog Scale Neck (-3.11 vs. -2.17, P =0.001), ∆Visual Analog Scale Arm (-2.92 vs. -1.48, P <0.001), ∆Neck Disability Index (-18.35 vs. -7.86, P <0.001), and ∆mJOA (3.38 vs. -0.56, P <0.001) compared with patients who did not. Worse baseline myelopathy severity predicts worse postoperative outcomes. However, baseline myelopathy severity is not predictive of the magnitude of postoperative improvement with the exception of mJOA. Patients who attain MCID improvement in mJOA had greater postoperative improvement for other health-related quality of life metrics.

Influence of psychiatric co-morbidity on health-related quality of life among major trauma patients.

The purpose of this study was to compare 1-year post-discharge health-related quality of life (HRQL) between trauma patients with and without psychiatric co-comorbidity. A retrospective single-center cohort study identified all severely injured adult trauma patients admitted to a Level 1 trauma center between 2018 and 2019. Bivariate analysis compared patients with and without psychiatric co-morbidity, which was defined as prior diagnosis by a healthcare provider or acute psychiatric consultation for new or chronic mental illness. HRQL metrics included the EuroQol-5D-5L (EQ-5D) questionnaire, visual analogue scale (EQ-VAS), and overall index score. A multiple linear regression model was utilized to identify predictors of EQ-5D index scores. Analysis of baseline characteristics revealed significantly greater rates of substance abuse, severe extremity injuries, inpatient morbidity, and hospital length-of-stay among patients with psychiatric illness. At 1-year follow-up, patients with psychiatric co-morbidity had lower median EQ-5D index scores compared to the control group (0.71, interquartile range [IQR] 0.32 vs. 0.79, IQR 0.22, p = 0.03). There were no differences between groups in individual EQ-5D dimensions, nor in EQ-VAS scores. Presence of psychiatric co-morbidity was not found to independently predict EQ-5D index scores in the linear regression model. Instead, Injury Severity Score (standardized regression coefficient [SRC] - 0.15, 95% confidence interval [CI] - 0.010 to - 0.001) and American Society of Anesthesiologists Physical Status score (SRC - 0.13, 95% CI - 0.08 to - 0.004) predicted poor HRQL 1-year after injury. Psychiatric co-morbidity does not independently predict low HRQL 1year after injury. Instead, lower HRQL scores among patients with psychiatric co-morbidity appear to be mediated by baseline health status and injury severity.

Do the newly proposed realignment targets for C2 and T1 slope bridge the gap between radiographic and clinical success in corrective surgery for adult cervical deformity?

Surgical correction of cervical deformity (CD) has been associated with superior alignment and functional outcomes. It has not yet been determined whether baseline or postoperative T1 slope (T1S) and C2 slope (C2S) correlate with health-related quality-of-life (HRQoL) metrics and radiographic complications, such as distal junctional kyphosis (DJK) and distal junctional failure (DJF). The objective of this study was to determine the impact of T1S and C2S deformity severity on HRQoL metrics and DJF development in patients with CD who underwent a cervical fusion procedure. All operative CD patients with upper instrumented vertebra above C7 and preoperative (baseline) and up to 2-year postoperative radiographic and HRQoL data were included. CD was defined as meeting at least one of the following radiographic parameters: C2-7 lordosis < -15°, TS1-cervical lordosis mismatch > 35°, segmental cervical kyphosis > 15° across any 3 vertebrae between C2 and T1, C2-7 sagittal vertical axis > 4 cm, McGregor's slope > 20°, or chin-brow vertical angle > 25°. Spearman's rank-order correlation and linear regression analysis assessed the impact of T1S and C2S on HRQoL metrics (Neck Disability Index [NDI], modified Japanese Orthopaedic Association [mJOA] scale, EuroQOL 5-Dimension Questionnaire [EQ-5D] visual analog scale [VAS] score, and numeric rating scale [NRS]-neck) and complications (DJK, DJF, reoperation). Logistic regression and a conditional inference tree (CIT) were used to determine radiographic thresholds for achieving optimal clinical outcome, defined as meeting good clinical outcome criteria (≥ 2 of the following: NDI < 20 or meeting minimal clinically important difference, mild myelopathy [mJOA score ≥ 14], and NRS-neck ≤ 5 or improved by ≥ 2 points), not undergoing reoperation, or developing DJF or mechanical complication by 2 years. One hundred five patients with CD met inclusion criteria. By surgical approach, 14.7% underwent an anterior-only approach, 46.1% a posterior-only approach, and 39.2% combined anterior and posterior approaches. The mean baseline radiographic parameters were T1S 28.3° ± 14.5° and C2S 25.9° ± 17.5°. Significant associations were found between 3-month C2S and mJOA score (r = -0.248, p = 0.034), NDI (r = 0.399, p = 0.001), EQ-5D VAS (r = -0.532, p < 0.001), NRS-neck (r = 0.239, p = 0.040), and NRS-back (r = 0.264, p = 0.021), while significant correlation was also found between 3-month T1S and mJOA score (r = -0.314, p = 0.026), NDI (r = 0.445, p = 0.001), EQ-5D VAS (r = -0.347, p = 0.018), and NRS-neck (r = 0.269, p = 0.049). A significant correlation was also found between development of DJF and 3-month C2S (odds ratio [OR] 1.1, 95% confidence interval [CI] 1.01-1.1, p = 0.015) as well as for T1S (OR 1.1, 95% CI 1.01-1.1, p = 0.023). Logistic regression with CIT identified thresholds for optimal outcome by 2 years: optimal 3-month T1S < 26° (OR 5.6) and C2S < 10° (OR 10.4), severe 3-month T1S < 45.5° (OR 0.2) and C2S < 38.0° (no patient above this threshold achieved optimal outcome; all p < 0.05). Patients below both optimal thresholds achieved rates of 0% for DJK and DJF, and 100% met optimal outcome. The severity of CD, defined by T1S and C2S at baseline and especially at 3 months, can be predictive of postoperative functional improvement and occurrence of worrisome complications in patients with CD, necessitating the use of thresholds in surgical planning to achieve optimal outcomes.

Determining the relationship between preoperative mental health scores and postoperative outcomes in adult spinal deformity surgeries.

The objective of this study was to examine the relationship between the mental health domain of the refined 22-item Scoliosis Research Society Outcome Questionnaire (SRS) and various postoperative outcome measures in the adult spinal deformity (ASD) population. Given the scale and involved nature of deformity surgery, some surgeons have proposed that preoperative mental health scores (MHSs) may assist in screening out poor surgical candidates. In this study, the authors aimed to further assess the SRS MHS as a preoperative metric and its association with postoperative outcomes and to comment on its potential use in patient selection and optimization for ASD surgery. The authors conducted a retrospective study of 100 consecutive patients who had undergone primary or revision ASD surgery at a single academic institution between 2015 and 2019. Each patient had a minimum 2-year follow-up. Patients were categorized on the basis of their baseline mental health per the SRS mental health domain, with a score < 4 indicating low baseline mental health (LMH) and a score ≥ 4 indicating high baseline mental health (HMH). Baseline and follow-up SRS and Oswestry Disability Index scores, surgical procedures, lengths of stay, discharge locations, intraoperative or postoperative complications, and other outcome metrics were then compared between the HMH and LMH groups, as well as these groups stratified by an age ≤ 45 and > 45 years. Among patients aged ≤ 45 and those aged > 45, the LMH group had significantly worse baseline health-related quality-of-life (HRQOL) metrics in nearly all domains. The LMH group also had an increased median estimated blood loss (EBL; 1200 vs 800 ml, p = 0.0026) and longer average surgical duration (8.3 ± 2.8 vs 6.9 ± 2.6 hours, p = 0.014). Both LMH and HMH groups had significant improvements in nearly all HRQOL measures postoperatively. Despite their worse preoperative HRQOL baseline, patients in the LMH group actually improved the most and reached the same HRQOL endpoints as those in the HMH group. While patients with lower baseline MHSs may require slightly longer hospital courses or more frequent discharges to rehabilitation facilities, these patients actually attain greater absolute improvements from their preoperative baseline and surprisingly have the same postoperative HRQOL metrics as the patients with high MHSs, despite their poorer starting point. This finding suggests that patients with LMH may be uniquely positioned to substantially benefit from surgical intervention and improve their HRQOL scores and thus should be considered for ASD surgery to an extent similar to patients with HMH.

Impacts of Financial Assistance on Quality of Life Among People Living With Burn Injury: Matched Cohort Analysis of the National Institute on Disability, Independent Living and Rehabilitation Research Burn Model System Database.

Disparities in socioeconomic status and minority status affect the risk of burn injury and the severity of that injury, thus affecting the subsequent cost of care. We aimed to characterize the demographic details surrounding receipt of financial assistance due to burn injury and its relationship with health-related quality of life scores. Participants ≥18 from Burn Model System National Longitudinal Database (BMS) with complete demographic data were included (n = 4330). Nonresponders to financial assistance questions were analyzed separately. The remaining sample (n = 1255) was divided into participants who received financial assistance because of burn injury, those who received no financial assistance, and those who received financial assistance before injury and as a result of injury. A demographic and injury-characteristic comparison was conducted. Health-related quality of life metrics (Satisfaction with Life, Short Form-12/Veterans RAND 12-Item Health Survey, Community Integration Questionnaire Social Component, and the Post-Traumatic Growth Inventory) were analyzed preinjury, then 6-months, 1-year, and 2-years postinjury. A matched cohort analysis compared these scores. When compared to their no financial assistance counterparts, participants receiving financial assistance due to burns were more likely to be minorities (19% vs 14%), have more severe injuries (%TBSA burn 21% vs 10%), and receive workers' compensation (24% vs 9%). They also had lower health-related quality of life scores on all metrics except the post-traumatic growth inventory. Financial assistance may aid in combating disparities in posttraumatic growth scores for participants at the greatest risk of financial toxicity but does not improve other health-related quality of life metrics.

Health-related quality of life in patients with resectable undifferentiated pleomorphic sarcoma treated with neoadjuvant checkpoint blockade in a single institution randomized phase II clinical trial.

11544 Background: In SARC028, patients with undifferentiated pleomorphic sarcoma (UPS) had a 40% overall response rate to pembrolizumab. Based on this, we conducted a randomized, phase II, non-comparative trial of combination nivolumab (nivo/RT) and ipilimumab (ipi/nivo/RT) and demonstrated an 89% major pathologic response. Here, we report the health-related quality of life (HRQoL) metrics. Methods: In this study (NCT03307616), patients with resectable UPS were randomized (1:1) to receive one dose of nivo (3mg/kg) or one dose of combination nivo (3 mg/kg) and ipi (1 mg/kg), followed by combination of nivo (3 doses, 3mg/kg every 2 weeks) plus 50 Gy in 25 fractions (both arms). HRQoL was assessed using the MD Anderson Symptom Inventory (MDASI), European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30, and the Functional Assessment of Cancer Therapy – General (FACT-G) questionnaires. Questionnaire completion rates were calculated using the number of patients with at least one baseline and post-baseline assessment. Analyses included mean change from baseline scores to week 11 (preoperative) and week 54 (postoperative). Results: Ten patients were randomized from October 2017 to February 2020. HRQoL were collected at baseline (n = 10) and at week 11 for five (83%) nivo/RT and three (60%) ipi/nivo/RT patients. Three (60%) nivo/RT and three (100%) ipi/nivo/RT patients had week 54 assessments. MDASI scores indicative of symptom severity and interference of daily life both decreased for patients undergoing ipi/nivo/RT (0.8→0.67 and 0.9→0.46, respectively) while both increased in the nivo/RT group (1.6→2.22 and 1.9→3.33, respectively). Both arms had similar increases at 54 weeks. Patients undergoing ipi/nivo/RT experienced a greater decline in EORTC-QLC global health status at 54 weeks than those undergoing single agent therapy (-22.92 vs -8.33). The mean change in total FACT-G score did not differ between the two arms at 11 weeks (-4.0 vs -4.5), however, there was a significant decline for patients undergoing ipi/nivo/RT at 54 weeks (-20.3 vs -5.7). Conclusions: For patients with resectable UPS, combination immune checkpoint blockade with ipi/nivo/RT is associated with an improvement in short term HRQoL compared to single-agent nivo/RT. This finding warrants further study with more patients, controlling for baseline symptom scores. Combination therapy was associated with a slower recovery to baseline function, with ongoing decline in HRQoL at 54 weeks post treatment. Our study demonstrates the feasibility of collecting HRQoL metrics, which can be key factors in guiding patient management decisions. Clinical trial information: NCT03307616.

Quality of life metrics in LVAD patients after hemocompatibility-related adverse events.

Hemocompatibility-related adverse events (HRAE) negatively influence survival. However, no study has examined the impact of these events on health-related quality of life (HRQOL) and functional outcomes following continuous-flow left ventricular assist device implantation (CF-LVAD). We assessed the impact of HRAE events on HRQOL and hypothesized that HRAE's adversely impact HRQOL and functional outcomes. INTERMACS database identified patients undergoing primary CF-LVAD implantation from 2008 to 2017. HRAEs included stroke, non-surgical bleeding, hemolysis, and pump thrombosis and were identified as defined in the literature. HRAEs were further stratified as Tier 1-2 and disabling stroke events. Time-series analysis was executed for HRAE patients with values pre-HRAE, post-HRAE, and closest to 12 months follow up. Local polynomial regression curves modeling individual patients were superimposed into "spaghetti" plots. All HRQOL and functional metrics improved in patients over time, despite HRAE complications. However, these patient metrics were significantly reduced compared to the non-HRAE cohort. Advanced data visualization techniques noted a decline after experiencing an HRAE with a subsequent recovery to baseline levels or higher. Six-minute walk test (6MWT) was noted to be most affected in the post-HRAE period but recovered similar to other metrics. The burden of HRAE following CF-LVAD implantation did not negatively impact the quality of life. However, the 6MWT did not increase in the post-HRAE period in all HRAE patients. Improvement of heart failure symptoms after CF-LVAD coupled with optimal management following the HRAE act to preserve the enhanced quality of life.

Association of Baseline Patient-reported Health-related Quality of Life Metrics with Outcome in Localised Prostate Cancer

AimsAlthough 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 localised prostate cancer. We report the association of baseline HR-QoL metrics with overall survival and toxicity in localised prostate cancer. Materials and methodsThis was a secondary analysis of a phase III randomised controlled study conducted in a single-payer health system. Patients with Gleason score ≤7, clinical stage T1b–T3a and prostate-specific antigen <30 ng/ml were randomised to neoadjuvant and concurrent androgen deprivation therapy (ADT) for 6 months starting 4 months before prostate radiotherapy or concurrent and adjuvant ADT for 6 months starting simultaneously with prostate radiotherapy. HR-QoL scores were estimated using the European Organisation for Research and Treatment of Cancer QoL questionnaire. A multistate Markov model was used to determine the association of baseline HR-QoL metrics with overall survival and a multilevel multivariable Cox regression was used to determine the association with the incidence of delayed-onset grade ≥3 radiotherapy-related toxicities. To adjust for multiple analyses, P < 0.025 was considered as statistically significant. ResultsOverall, 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 1.020, 95% confidence interval 1.010–1.030, P = 0.02) and dyspnoea (hazard ratio 1.020, 95% confidence interval 1.003–1.030, P = 0.01) were associated with inferior overall survival. Baseline dyspnoea was associated with a higher incidence of grade ≥3 toxicity (hazard ratio 1.020, 95% confidence interval 1.010–1.030, P = 0.023). ConclusionIn a cohort of localised prostate cancer patients treated with radiotherapy and short-term ADT, a 10-point higher baseline financial difficulty or dyspnoea was associated with a 20% increased risk of death. With each 10-point increase in baseline dyspnoea, we noted a 20% increase in the associated risk of grade ≥3 delayed-onset radiotherapy-related toxicity.

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.

Comorbidity Prevalence and Impact on Quality of Life in Gay and Bisexual Men Following Prostate Cancer Treatment.

IntroductionStudies have demonstrated worse health related quality of life (HRQOL) outcomes in gay and bisexual men (GBM) following prostate cancer treatment compared to heterosexual men potentially due to differences in comorbidity burden.AimTo establish the prevalence of comorbidities and their association with HRQOL metrics in GBM following prostate cancer treatment.MethodsWe evaluated HRQOL and prevalence of comorbidities in 193 GBM from the United States and Canada in a cross-sectional, online survey: the Masked for Review. HRQOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) and the 12-Item Short Form Health Survey (SF-12).Main Outcome MeasuresOur outcomes included comorbidity prevalence, mean differences for HRQOL scores by comorbidity status, and mean differences for HRQOL by comorbidity count.ResultsGBM were found to have a higher prevalence of blood vessel disease and mental health disorders but lower prevalence of obesity and type 2 diabetes when compared to published data in general prostate cancer populations. Statistically significant reductions in HRQOL metrics were associated with mental health diagnoses, diabetes, and obesity. Increased number of comorbidities was also associated with reductions in HRQOL metrics in nearly all categories.ConclusionThese results suggest that the worse QOL outcomes in GBM following prostate cancer treatment may be due to differences in comorbidity burden. This study is the first to evaluate the relationship between comorbidities and HRQOL outcomes in GBM. Limitations of this study include a small sample size and cross-sectional study design. If confirmed in larger, longitudinal, clinically confirmed studies, these findings indicate a need to intervene on and consider comorbidities in GBM diagnosed with prostate cancer.Haggart R, Polter E, Ross M, et al. Comorbidity Prevalence and Impact on Quality of Life in Gay and Bisexual Men Following Prostate Cancer Treatment. Sex Med 2021;9:100439.

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

Donor quality of life after living donor liver transplantation: a review of the literature.

Living donor liver transplantation (LDLT) provides a source for transplant in the setting of the deceased donor organ shortage. Seeing as living donors do not derive any medical benefit from the procedure, fully understanding the impact of donation on donor health-related quality of life (HRQOL) is essential. A systematic search of the MEDLINE database was performed from 2008–2020, using relevant Medical Subject Headings. Articles were evaluated for study design, cohort size and follow-up time and excluded if they contained significant methodological flaws. A total of 43 articles were included: 20 (47%) were cross-sectional and 23 (53%) were longitudinal. The mean number of donors per study was 142 (range:8–578) with follow-up ranging from 12–132 months. Forty-two unique HRQOL metrics were implemented across the 43 studies, the majority of which were questionnaires. Of the 31 studies that used the Medical Outcomes Study Short Form 36 questionnaire, 9.1% of donors reported physical QOL did not return to pre-LDLT levels for at least 2 years after donation. Mental QOL remained stable or improved after LDLT, with mean mental composite scores increasing from 50 to 52 at 3 months post-LDLT in one study. The predicted probability of poor sexual desire decreased at 1-year post-LDLT (male: 0.08, female: 0.26) relative to pre-LDLT (male: 0.44, female: 0.76; P<0.001) and three months post-LDLT (male: 0.35, female 0.69; P=0.001). Forty percent of donors found LDLT to be financially burdensome at 3 months and 19% at 2 years post-LDLT. Female gender and obesity were consistent predictors of worse HRQOL. Laparoscopy-assisted donor hepatectomy was associated with shorter hospitalizations than open donor hepatectomy (10.3 vs. 18.3 days, P=0.02). No studies used the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) measures of HRQOL. Our review demonstrates that LDLT can have a long-lasting negative impact on physical QOL in 9.1% of donors and can cause both sexual dysfunction and significant financial strain. Future studies should consider using standardized and extensively validated patient reported outcomes measures, such as PROMIS, in order to directly compare outcomes across studies and gain further insight into the impact of LDLT on D-HRQOL.

P104. Identifying C2 slope and T1 slope thresholds for optimal functional and clinical outcomes in cervical deformity correction

<h3>BACKGROUND CONTEXT</h3> Surgical correction of cervical deformity (CD) has been associated with superior alignment and functional outcomes. It has not yet been determined whether baseline and postoperative T1 slope and C2 slope correlate with health-related quality of life (HRQL) metrics and radiographic complication. <h3>PURPOSE</h3> To determine the impact of T1S and C2S deformity severity on HRQL metrics and DJK development in operative cervical deformity patients. <h3>STUDY DESIGN/SETTING</h3> Retrospective cohort study. <h3>PATIENT SAMPLE</h3> A total of 119 CD patients. <h3>OUTCOME MEASURES</h3> Radiographic parameters; HRQLs. <h3>METHODS</h3> Included: Operative CD patients with UIV above C7 and with pre-(BL) and up to 2-year (2Y) postop radiographic/HRQL data. Cervical deformity was defined as meeting at least one of the following radiographic parameters: C2-C7 lordosis < -15°, TS-CL >35°, segmental cervical kyphosis >15° across any 3 vertebra between C2-T1, C2-C7 SVA >4cm, McGregor's slope >20°, or CBVA > 25°. Spearman's rank-order correlation and linear regression analysis assessed the impact of baseline T1 slope (T1S) and C2 slope (C2S) on baseline HRQL metrics (NDI, mJOA, EQ5D, NRS Neck, NRS Back), and the impact of postoperative T1S and C2S on follow-up HRQLs. Logistic regression and conditional inference tree (CIT) machine learning were used to determine baseline radiographic thresholds for improving in ≥2 HRQL metrics from BL to 2Y, and 2Y radiographic thresholds for developing DJK or DJF by 2Y postop. <h3>RESULTS</h3> A total of 119 CD patients met inclusion criteria (61.2±10.5years, 63%F, BMI 29.0±7.5kg/m2, CCI: 1.00±1.31) and underwent surgery (levels fused 7.5±3.7, EBL 990mL, op time 547min). By approach, 19.3% anterior-only, 44.5% posterior-only, and 36.1% combined. Mean BL radiographic parameters: PT 19.6°, PI-LL 1.4°, SVA 1.9mm, T2-T12 kyphosis -46.8°, C2-C7 lordosis -9.0°, T1S 29.0°, TS-CL 38.2°, C2S 37.7°, cSVA 44.0mm, and C2-T3 -18.0°. Mean BL HRQLs were as follows: NRS back 5.0, NRS neck 6.7, NDI 47.9, mJOA 13.5, and EQ5D 0.74. Spearman correlation and linear regression identified no association between baseline T1S or C2S and HRQL metrics, or between 2Y postop T1S and HRQLs (all p>0.05). Correlation and linear regression found significant associations of higher C2S with higher NDI (p=0.042), lower mJOA (p=0.011), and lower EQ5D (p=0.009), all indicating higher degree of disability at 2Y postop. Logistic regression with CIT identified thresholds for improving in 2 or more HRQL metrics by 2Y postop: baseline T1S < 32.8° (OR: 2.47) and C2S <46.7° (OR: 2.40); both p<0.05. Regression and CIT also identified postoperative radiographic thresholds for developing DJK or DJF by 2Y: T1S >45.3° (OR: 16.0) and C2S >32.5° (OR: 6.07); both p<0.05. <h3>CONCLUSIONS</h3> Baseline deformity severity in terms of T1 slope and C2 slope can be predictive of postoperative functional outcomes in cervical deformity patients, while postoperative deformity in T1S and C2S can be predictive of DJK and DJF occurrence. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Cardiorespiratory Fitness After Open Repair for Acute Type A Aortic Dissection – A Prospective Study

Cardiorespiratory fitness (as measured by peak oxygen consumption [VO2peak]) is an independent predictor of cardiovascular disease and all-cause mortality. Limited data exist on VO2peak following repair for an acute type A aortic dissection (ATAAD) or proximal thoracic aortic aneurysm (pTAA). This study prospectively evaluated VO2peak, functional capacity, and health-related quality of life (HR-QOL) following open repair. Participants with a history of an ATAAD (n=21) or pTAA (n=43) performed cardiopulmonary exercise testing (CPX), 6-minute walk testing, and HR-QOL at 3 (early) and 15 (late) months following open repair. The median age at time of surgery was 55-years-old and 60-years-old in the ATAAD and pTAA groups, respectively. Body mass index significantly increased between early and late timepoints for both ATAAD (p=0.0245, 56% obese) and pTAA groups (p = 0.0045, 54% obese). VO2peak modestly increased by 0.8 mLO2·kg-1·min-1 within the ATAAD group (p=0.2312) while VO2peak significantly increased by 2.2 mLO2·kg-1·min-1 within the pTAA group (p=0.0003). Anxiety significantly decreased in the ATAAD group whereas functional capacity and HR-QOL metrics (social roles and activities, physical function) significantly improved in the pTAA group (p values < 0.05). There were no serious adverse events during CPX. Cardiorespiratory fitness among the ATAAD group remained 36% below predicted normative values >1 year after repair. CPX should be considered post-operatively to evaluate exercise tolerance and blood pressure response to determine whether mild-to-moderate aerobic exercise should be recommended to reduce future risk of morbidity and mortality.

Measuring Quality of Life Following Robot-Assisted Radical Prostatectomy.

BackgroundProstate cancer (PCa) represents the most common solid organ malignancy in men. Fortunately, at the time of diagnosis, the majority of cases are staged as localized or regional disease, conferring excellent 5- and 10-year cure rates. There are several first line treatment options including surgical approaches such as robot-assisted radical prostatectomy (RARP) and radiation therapy (RT) available to patients with localized disease that offer similar PCa oncologic outcomes but are associated with potentially significant side effects which may impact health-related quality of life (HRQOL) domains. Recently, clinicians and investigators have sought to better understand these changes in HRQOL metrics with the utilization of patient-reported outcomes (PRO). Given that RARP represents the most common surgical treatment for PCa in the United States, there has been a particular interest in assessing these outcomes derived by patient perspectives to more fully appreciate treatment-related impact on quality of life following RARP.ObjectiveThis narrative review sought to explore the instruments available to measure quality of life after RARP, a review of the PRO data after RARP, and future directions for assessing and improving quality of life outcomes following this surgery.Clinical UseThere are several treatment options for men diagnosed with local and regional prostate cancer with similar oncologic outcomes but differing patterns of side effects affecting post-treatment quality of life. Understanding data reported directly by patients following RARP about their side effects and quality of life gives providers additional information for appropriate preoperative counseling for patients choosing between treatment options for their prostate cancer.