Worse Quality Of Life Outcomes Research Articles

Prospective Assessment of Quality of Life and Patient-Reported Toxicities Over the First Year After Chimeric Antigen Receptor T-Cell Therapy

Chimeric antigen receptor (CAR) T-cell therapy has transformed survival outcomes in patients with relapsed and refractory large B-cell lymphoma (LBCL), but it is associated with a variety of side effects. This study examined changes in patient-reported quality of life (QoL) and toxicities, as well as risk factors for worse QoL and toxicities, in the first year after treatment. Patients with LBCL completed questionnaires assessing QoL and toxicity severity before infusion, and 90, 180, and 360 days after infusion. Mixed models were used to examine changes in QoL and toxicities over time, and clinical moderators of change in QoL and toxicities. Patients reported improvements in physical functioning and fatigue in the year after treatment (P values <.01), but there were no changes in pain, anxiety, or depression over time. Patients with active disease at day 90 reported more physical dysfunction at all postinfusion timepoints (Ps ≤ .01) compared to patients who responded to treatment. Similarly, patients with active disease at day 90 reported worsening depression over time, such that at day 360, depressive symptoms were worse for patients with active disease than patients without active disease (P = .02). Patients treated with 4+ lines of prior therapy reported worsening pain and anxiety over time, such that at day 360, both pain and anxiety were significantly worse for patients previously treated with 4 of more lines of therapy than patients treated with fewer lines of therapy (Ps ≤ .01). Regarding toxicities, patients reported decreasing overall toxicity burden up to day 180, with subsequent worsening at day 360 (P = .02). Most patients reported at least one or two grade 2 toxicities at each timepoint. Patients demonstrated unchanging or improved QoL after treatment with CAR T-cell therapy, but active disease and greater prior lines of therapy were associated with worse QoL outcomes over time. Toxicity severity also improved during the first 6 months post-treatment, but worsened thereafter, particularly among patients with active disease after treatment.

To Operate or Not to Operate? Reconstructive Surgical Burden and Quality of Life of Pediatric Patients with Facial Differences.

The Craniofacial Condition Quality of Life Scale (CFC-QoL) was used to evaluate the relationship between surgical burden and quality of life (QoL). Patient-parent dyads completed the CFC-QoL which queries the following QoL domains: Bullying, Peer Problems, Psychological Impact, Family Support, Appearance Satisfaction, and Desire for Appearance Change. Stepwise multivariate linear regressions were performed for each QoL domain. Urban tertiary care center. Pediatric patients with facial differences, and their parents. Survey study. Demographic, diagnostic, and surgical characteristics were collected. Surgical burden was calculated as the standard deviation from the mean number of surgeries per diagnostic cohort. Patients (N = 168) were majority female (57.1%) and Hispanic (64.3%). Diagnoses were cleft lip and/or palate (CLP,n = 99) or other craniofacial conditions (CFC,n = 69). Average patient age was 2.3 ± 5.6 years at first reconstructive surgery and 12.3 ± 3.4 years at study enrollment. Patients received an average of 4.3 ± 4.1 reconstructive surgeries.Worse Bullying was associated with higher surgical burden. Worse Peer Problems was associated with higher surgical burden, but only for children with non-CLP CFCs. Worse Family Support was associated with CFC diagnosis, female sex, and higher surgical burden. Worse Psychological Impact was associated with higher surgical burden. Worse Appearance Satisfaction was associated with younger age and with lower surgical burden. Greater Desire for Appearance Change was associated with older age, higher surgical burden, CLP diagnosis, female sex, and non-Hispanic ethnicity. Socioeconomic status did not predict QoL per patient self- or parent-proxy report. Higher surgical burden was associated with worse QoL outcomes in multiple domains.

Quality of life outcomes for patients with metastatic castration-resistant prostate cancer and pretreatment prognostic score.

A prognostic risk score (Halabi score) in metastatic castration-resistant prostate cancer (mCRPC) accurately predicts overall survival, but its association with quality of life (QOL) has not been defined. We hypothesize that a higher pretreatment Halabi score is associated with worse QOL outcomes over time in mCRPC patients. Patient-level data from the docetaxel plus prednisone control arm of Mainsail, a Phase 3 clinical trial in mCRPC were accessed via ProjectDataSphere. Pretreatment Halabi score included disease-related factors: metastatic site, opioid use, Eastern Cooperative Oncology Group performance status (ECOG-PS), alkaline phosphatase, albumin, hemoglobin, lactic acid dehydrogenase, and PSA, with higher score indicating worse survival. Three QOL scales were created: Functional Assessment of Cancer Therapy-Prostate (FACT-P, higher score = better QOL), Brief Pain Inventory-Short Form Severity score (BPI-SFSS, higher score = higher pain severity), and BPI-SF Interference score (BPI-SFIS, higher score = greater pain interference). Mixed linear model was used to estimate the associations between Halabi score and QOL scores assessed at different time points (baseline, 2 months, and 6 months). This analysis included 412 mCRPC patients (median age = 68 years, 82% white, 5% Black, median log PSA = 4.4 ng/mL). After multivariable adjustment, Halabi score was significantly associated with QOL scores at all time points. At 6 months, multivariable adjusted FACT-P decreased by 10.0 points (worsening), BPI-SFSS increased by 0.8 points (worsening), and BPI-SFIS increased by 0.9 points (worsening) for each unit increase in Halabi risk score. In multivariable analysis of individual components, ECOG-PS, site of metastasis, and opioid use were significantly associated with worse QOL scores at baseline. Chemotherapy-naïve mCRPC patients with poorer Halabi prognostic risk scores have poorer QOL and greater pain intensity and interference at baseline and during follow-up.

Should patients with lumbar stenosis and grade I spondylolisthesis be treated differently based on spinopelvic alignment? A retrospective, two-year, propensity matched, comparison of patient-reported outcome measures and clinical outcomes from multiple sites within a single health system

BACKGROUNDDegenerative lumbar spondylolisthesis is one of the most common pathologies addressed by surgeons. Recently, data demonstrated improved outcomes with fusion in conjunction with laminectomy compared to laminectomy alone. However, given not all degenerative spondylolistheses are clinically comparable, the best treatment option may depend on multiple parameters. Specifically, the impact of spinopelvic alignment on patient reported and clinical outcomes following fusion versus decompression for grade I spondylolisthesis has yet to be explored. PURPOSEThis study assessed two-year clinical outcomes and one-year patient reported outcomes following laminectomy with concomitant fusion versus laminectomy alone for management of grade I degenerative spondylolisthesis and stenosis. The present study is the first to examine the effect of spinopelvic alignment on patient-reported and clinical outcomes following decompression alone versus decompression with fusion. STUDY DESIGN/SETTINGRetrospective sub-group analysis of observational, prospectively collected cohort study. PATIENT SAMPLE679 patients treated with laminectomy with fusion or laminectomy alone for grade I degenerative spondylolisthesis and comorbid spinal stenosis performed by orthopaedic and neurosurgeons at three medical centers affiliated with a single, tertiary care center. OUTCOME MEASURESThe primary outcome was the change in Patient-Reported Outcome Measurement Information System (PROMIS), Global Physical Health (GPH), and Global Mental Health (GMH) scores at baseline and post-operatively at 4-6 and 10-12 months postoperatively. Secondary outcomes included operative parameters (estimated blood loss and operative time), and two-year clinical outcomes including reoperations, duration of postoperative physical therapy, and discharge disposition. METHODSRadiographs/MRIs assessed stenosis, spondylolisthesis, pelvic incidence, lumbar lordosis, sacral slope, and pelvic tilt; from this data, two cohorts were created based on pelvic incidence minus lumbar lordosis (PILL), denoted as “high” and “low” mismatch. Patients underwent either decompression or decompression with fusion; propensity score matching (PSM) and coarsened exact matching (CEM) were used to create matched cohorts of “cases” (fusion) and “controls” (decompression). Binary comparisons used McNemar test; continuous outcomes used Wilcoxon rank-sum test. Between-group comparisons of changes in PROMIS GPH and GMH scores were analyzed using mixed-effects models; analyses were conducted separately for patients with high and low pelvic incidence-lumbar lordosis (PILL) mismatch. RESULTS49.9% of patients (339) underwent lumbar decompression with fusion, while 50.1% (340) received decompression. In the high PLL mismatch cohort at 10-12 months postoperatively, fusion-treated patients reported improved PROs, including GMH (26.61 vs. 20.75, p<0.0001) and GPH (23.61 vs. 18.13, p<0.0001). They also required fewer months of outpatient physical therapy (1.61 vs. 3.65, p<0.0001) and had lower 2-year reoperation rates (12.63% vs. 17.89%, p=0.0442) compared to decompression-only patients. In contrast, in the low PLL mismatch cohort, fusion-treated patients demonstrated worse endpoint PROs (GMH: 18.67 vs. 21.52, p<0.0001; GPH: 16.08 vs. 20.74, p<0.0001). They were also more likely to require skilled nursing/rehabilitation centers (6.86% vs. 0.98%, p=0.0412) and extended outpatient physical therapy (2.47 vs. 1.34 months, p<0.0001) and had higher 2-year reoperation rates (25.49% vs. 14.71%,p=0.0152). CONCLUSIONSLumbar laminectomy with fusion was superior to laminectomy in health–related quality of life and reoperation rate at two years postoperatively only for patients with sagittal malalignment, represented by high PILL mismatch. In contrast, the addition of fusion for patients with low-grade spondylolisthesis, spinal stenosis, and spinopelvic harmony (low PILL mismatch) resulted in worse quality of life outcomes and reoperation rates.

Analysis of tinnitus severity and associated factors in patients with chronic otitis media in a low- to middle-income country

Objective This study aimed to describe the tinnitus severity in patients with chronic otitis media (COM) and describe the sociodemographic and clinical variables associated with tinnitus severity. Design Cross-sectional study. Two otology-referral centers in Bogotá (Colombia) were included. Sociodemographic, clinical associated factors and quality of life questionnaires were applied. Otoscopic evaluation and audiometric data were collected. Study sample About 231 adults with COM. Results Up to 51.5% of the patients reported severe tinnitus discomfort, 21.7% moderate discomfort, and 26.8% minor discomfort. Factor associated with increased tinnitus severity in patients with COM were older age (aOR: 1.02; 95% CI: 1.01–1.05), higher education (aOR: 2.24; 95% CI: 1.03–4.87), ear discharge during childhood (aOR: 1.88; 95% CI: 1.02–3.45), cholesteatoma in one ear (aOR: 2.26; 95% CI: 1.05–4.88), and pure-tone air average over 15 dB (aOR: 2.08; 95% CI: 1.28–3.36). Differences of 10-points in symptoms severity and 15-points in the total score of the “Chronic Suppurative Otitis Media Questionnaire-12” were found between the tinnitus severity groups. Conclusions Our results highlight the need for further research on the associated factors of tinnitus severity on COM patients. COM patients with higher tinnitus severity presented worse audiometric results and worse quality of life outcomes.

Quality of Life Outcomes Over Time in Patients With Unruptured Intracranial Aneurysms With and Without Preventive Occlusion: A Prospective Cohort Study.

In counseling patients with an unruptured intracranial aneurysm (UIA), quality of life (QoL) outcomes are important for informed decision making. We evaluated QoL outcomes in patients with and without preventive aneurysm occlusion at multiple time points during the first year after UIA diagnosis and studied predictors of QoL outcomes. We performed a prospective cohort study in patients aged ≥18 years with a newly diagnosed UIA in 2 tertiary referral centers in the Netherlands between 2017 and 2019. Patients were sent QoL questionnaires at 7 (aneurysm occlusion) or 5 (no occlusion) moments during the first year after diagnosis. We collected baseline data on patient and aneurysm characteristics, passive coping style (Utrecht Coping List), occlusion modality, and neurologic complications. We assessed health-related QoL (HRQoL) with the EuroQol 5 dimensions (EQ-5D), emotional functioning with the Hospital Anxiety and Depression Scale (HADS), and restrictions in daily activities with the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P). We used a linear mixed-effects model to assess the course of QoL over time and to explore predictors of QoL outcomes. Of 153 eligible patients, 99 (65%) participated, of whom 30/99 (30%) underwent preventive occlusion. Patients undergoing occlusion reported higher baseline levels of passive coping, anxiety and depression, and restrictions than patients without occlusion. During recovery after occlusion, patients reported more restrictions compared with baseline (adjusted USER-P decrease 1 month post occlusion: -12.8 [95% CI -23.8 to -1.9]). HRQoL and emotional functioning gradually improved after occlusion (EQ-5D increase at 1 year: 8.6 [95% CI 0.1-17.0] and HADS decrease at 1 year: -5.4 [95% CI -9.4 to -1.5]). In patients without occlusion, the largest HRQoL improvement occurred directly after visiting the outpatient aneurysm clinic (EQ-5D increase: 9.2 [95% CI 5.5-12.8]). At 1 year, QoL outcomes were comparable in patients with and without occlusion. Factors associated with worse QoL outcomes were a passive coping style in all patients, complications in patients with occlusion, and higher rupture risks in patients without occlusion. After UIA diagnosis, QoL improves gradually after preventive occlusion and directly after counseling at the outpatient clinic in patients without occlusion, resulting in comparable 1-year QoL outcomes. A passive coping style is an important predictor of poor QoL outcomes in all patients with UIA.

OP0028 EARLY ACHIEVEMENT OF MINIMAL DISEASE ACTIVITY IN PSORIATIC ARTHRITIS IS ASSOCIATED WITH LONG-TERM IMPROVEMENTS IN QUALITY OF LIFE

BackgroundMinimal disease activity (MDA) is a treatment target in psoriatic arthritis (PsA) that takes both clinical manifestations (joints, skin and enthesis) and the patient perspective into account (1). In a previous study we have shown that achieving MDA in the first year is associated with better quality of life (QoL) regardless whether this was achieved early or late in the first year (2). However, the impact of achieving MDA within the first year on the long-term is lacking.ObjectivesTo compare quality of life at 1, 2 and 3 years between PsA patients who achieve MDA in the first year and those who do not.MethodsNewly diagnosed, DMARD naïve PsA patients with oligo- or polyarthritis and at least 3 years of follow-up, participating in the Dutch southwest Early PsA cohoRt (DEPAR) were included. In short the DEPAR is an observational cohort of newly diagnosed PsA (3). Study visits took place at 3, 6, 9, 12, 18, 24 and 36 months after diagnosis. Patients were categorized in three groups by achievement of MDA in the first year:Sustained MDA, includes patients who were in MDA at both their 9- and 12-month visit;Non-sustained MDA, includes patients who achieved MDA in the first year but did not sustain it at both 9- and 12-months;No MDA, includes patients who did not achieve MDA in the first year.To measure QoL at 1, 2 and 3 years the Short form-36 (SF-36) questionnaire was used. Descriptive statistics were used to compare QoL.ResultsWe included 243 patients (51% male) of whom 113 (47%) were classified as sustained MDA, 64 (26%) as non-sustained MDA and 66 (27%) as no MDA. At baseline, patients had a mean age of 52.7 years and median symptom duration of 9.3 months. Patients in the no MDA group seemed to be older, were more often female and had a longer symptom duration (Table 1). QoL of sustained MDA patients was comparable to the general Dutch population (4) after 1, 2 and 3 years of follow-up. However, patients who did not achieve MDA in the first year had a lower QoL compared to the sustained MDA group and these differences persist in the years thereafter (Figure 1). The physical as well as the mental QoL domains were worse in the no MDA group compared to the other groups.Table 1.Baseline characteristics of patients categorized by MDA groupSustained MDA (n=113)Non-sustained MDA (n=64)No MDA(n=66)Demographics Age (years)51.8 ± 1351.8 ± 1455.3 ± 13 Sex (male)69 (61)33 (52)21 (32) Symptom duration (months)8.5 (4-24)8.1 (3-28)12.9 (5-51)Disease activity Swollen joint count (66)3 (2-5)4 (1-6)4 (2-8) Tender joint count (68)3 (1-6)4 (2-8)8 (4-13) Psoriasis95 (84)58 (91)56 (85) BSA in case of psoriasis (%)3 (2-4)3.3 (1-6.5)3 (1.5-6) Enthesitis29 (26)28 (44)38 (58) LEI in case of enthesitis1 (1-2)2 (1-2)2 (1-4)HAQ0.38 (0.13-0.75)0.75 (0.5-1)1 (0.75-1.38)VAS global31 (15-56)46 (23-65)59 (50-77)VAS pain28 (12-52)50 (26-66)69 (53-80)Results are shown as mean ± standard deviation, n (%) or median (interquartile range). BSA: Body Surface Area; LEI: Leeds Enthesitis Index; HAQ: Health Assessment Questionnaire; VAS: visual analogue scale.Figure 1.(A) 1 year, (B) 2 year and (C) 3 year quality of life scores, measured with the SF-36 domains, for MDA groups and compared with the general Dutch population norms (4), (D) percentage of patients who use biologicals over time per MDA group.Over the years, treatment was intensified in all groups, with biologicals use after three years at 18%, 25% and 31% in the sustained MDA, non-sustained MDA and no MDA group, respectively.ConclusionFailure to achieve MDA in the first year after PsA diagnosis is associated with worse quality of life outcomes that persist over the years despite more intensified treatment.

Patients with NSTEMI have fewer symptoms and higher quality of life three months after admission for acute chest pain

Abstract Background A substantial proportion of patients admitted for possible non-ST elevation acute coronary syndrome (NSTE-ACS) who are not diagnosed with non-ST elevation myocardial infarction (NSTEMI) suffer from conditions (e.g. chronic myocardial injury [CMI]) that may imply serious cardiac risk and impaired quality of life. It is unknown what predicts quality of life and recurrence of symptoms in chest pain patients. Purpose To investigate which demographic and clinical characteristics, including discharge diagnosis, that predict recurrent symptoms and quality of life three months after hospitalization for acute chest pain. Methods A total of 1506 patients ≥18 years admitted with suspected NSTE-ACS at Haukeland University Hospital, Bergen, Norway, were included in the WESTCOR study. The final diagnosis was adjudicated by two independent cardiologists based on all clinical data including routine cTnT (5th gen, Roche Diagnostics). Three months after discharge patients received questionnaires assessing general health (SF-12v1), angina-related health (SAQ-7) and dyspnea (Rose Dyspnea Scale). In all, 774 (51.3%) patients responded and were included in the analyses. Univariable and multivariable regression models were applied to identify predictors of symptoms and quality of life scores after adjusting for a subset of candidate predictors. A subgroup analysis was undertaken in patients with stable troponin concentrations (N=658). Results Based on the discharge diagnosis the patients were grouped as NSTEMI (14.2%), unstable angina pectoris (UAP) (16.9%), non-coronary cardiac disease (6.6%), non-cardiac disease (6.3%) and non-cardiac chest pain (NCCP) (56.0%). After three months the NSTEMI patients had the highest quality of life scores and the lowest prevalence of symptoms (angina and dyspnea), while the inverse was true for the UAP patients (Fig 1). Revascularized patients had a better quality of life compared to those treated conservatively (P&amp;lt;0.001). Adjusted multivariable analysis also demonstrated that revascularization (β=0.19, P=0.002) and a diagnosis of UAP (β=−0.18, P=0.007) succeeded to predict angina frequency. Additionally, current smoking and hypertension were also associated with worse quality of life outcomes (Table 1). NCCP patients had high median prevalence of symptoms after three months, with 50% of the group reporting chest pain in the last four weeks, and 33% reporting dyspnea. In the subgroup analysis, current smoking predicted worse quality of life in all domains (all P&amp;lt;0.05) except SAQ7-Angina frequency. Conclusions Three months after hospitalization for chest pain revascularized patients had better quality of life and less symptoms compared to other patient groups. A diagnosis of UAP predicted recurrent symptoms and impaired quality of life in patients, suggesting that closer monitoring should be considered in order to minimize re-hospitalization. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): The study is funded by grants from the Western Norway Regional Health Authority, Haukeland and Stavanger University hospitals. Figure 1Table 1

Post-Stroke Quality of Life Outcomes After Instituting New Stroke Care Quality Indicators

Background: In 2013 the Israel Ministry of Health identified the care and treatment of acute cerebral ischemic stroke as failing to achieve expected standards. The Ministry decided to raise standards by defining and instituting, nationwide, a battery of linked care quality indicators to be applied across all relevant facilities and contexts. Five indicators were selected for five key junctures in the AIS care process.&#x0D; Methods: This paper presents and analyses the effects of the implementation of these new care quality indicators on the post-discharge quality of life outcomes of Israeli stroke sufferers. The patient sample comprises patients from Israel’s Central region, where stroke care provision and access is relatively high, and from the peripheral North region, where provision and access are limited.&#x0D; Results: Those who were not treated with thrombolytic treatment and/or cerebral blood vessel catheterization, those who suffered severer strokes, women, the older age groups, non-Jews and North region residents display significantly worse physical functioning outcomes and worse quality of life outcomes on all indicators.&#x0D; Conclusions: Stroke care access and provision disparities translate into significantly higher rates of post-discharge disability, impaired physical and social functioning, and a lower quality of life.&#x0D; The effectiveness of healthcare improvement by the deployment of care indicators is closely associated with the lifestyle, socio-demographic and socioeconomic status of different population groups. The effective implementation of quality care indicators also relies heavily on closing the access and provision gaps between the populations living in central and peripheral areas. Two obvious directions for action are to expand and improve the rehabilitation care network and to combat the age discrimination in hospital stroke treatment.

Impact of Non–guideline-directed Care on Quality of Life in Testicular Cancer Survivors

BackgroundNon–guideline-directed care (NGDC) is seen in ∼30% of testicular cancer patients and has been identified as a significant predictor of relapse. However, the potential impact of mismanagement on patient quality of life (QoL) is yet to be established. ObjectiveTo explore the impact of NGDC on long-term QoL in testicular cancer survivors (TCSs). Design, setting, and participantsA retrospective review of TCSs, who completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in person or via mail ≥6 mo after completion of treatment, was conducted. Outcome measurements and statistical analysisThe validated questionnaire evaluates global health status (GHS); cognitive, social, physical, emotional, and role functioning; financial burden; and treatment-specific side effects. Results and limitationsA total of 120 men with a median age of 31.5 (interquartile range: 24–42) yr completed the questionnaire. Thirty-four (28%) men received NGDC: overtreatment (44%), improper imaging (32%), and undertreatment (29%). Men with NGDC presented with a more advanced clinical stage (≥IIA: 64% vs 32%, p = 0.007) and were less likely to undergo surveillance (19% vs 37%, p = 0.016). Patients receiving guideline-directed care reported higher GHS (84.1 vs 77.5, p = 0.015), higher physical function scores (98.5 vs 91.2, p = 0.013), and fewer financial difficulties (5.8 vs 18.6, p = 0.006) than those receiving NGDC. Multivariable linear regression showed a significant association between NGDC and poorer GHS (p = 0.002). Limitations of the study include its retrospective nature, modest sample size due to a 21% response rate, and quality-of-life assessment at a single time point rather than serially over time. ConclusionsIn addition to treatment delay, avoidable morbidity, and higher rates of relapse, NGDC leads to inferior global QoL, worse physical functioning, and more financial stress. Patient summaryWe have previously shown how mismanagement of testicular cancer results in a higher rate of disease relapse. In this study, we emphasize how the lack of adherence to standard treatment guidelines can lead to worse quality of life outcomes and financial stress in testicular cancer survivors.

Baseline Predictors of Longitudinal Changes in Symptom Severity and Quality of Life in Patients With Suspected Gastroparesis

Whether gastric emptying tests predict longitudinal outcomes in patients with symptoms of gastroparesis is unclear. We aimed to determine whether baseline gastric emptying tests and gut motility parameters could impact longitudinal symptom(s) and quality of life (QOL) in a prospective, observational cohort study of patients with symptoms of gastroparesis. One hundred fifty patients with gastroparesis symptoms underwent simultaneous scintigraphy (GES) and wireless motility capsule (WMC) measurement of gastric emptying and other motility parameters. Patient Assessment of Upper Gastrointestinal Symptoms and Quality of Life were administered at baseline, and 3 and 6 months after testing. Multivariable generalized linear marginal models were fit to determine which baseline parameters predict longitudinal changes in symptoms and QOL. Overall upper GI symptoms and QOL scores were moderate in severity at baseline and significantly improved over 6 months. Clinical variables, including female gender, harder stools by Bristol stool form score, and presence of functional dyspepsia (FD) by Rome III criteria, were predictive of more severe upper GI symptoms. Even after controlling for these clinical factors, delayed gastric emptying by GES or WMC was associated with worse symptom severity and QOL scores. Low gastric and elevated small bowel contractile parameters by WMC were also independently associated with more severe upper GI symptoms and worse QOL scores. Baseline features, including demographic and clinical variables, delayed gastric emptying and abnormal gastrointestinal contractility, were independent predictors of more severe longitudinal symptoms and worse quality of life outcomes. These factors may help to risk stratify patients and guide treatment decisions. ClinicalTrials.gov no: NCT02022826.

Age-Related Differences in Quality of Life After 5 Years From Endovascular and Open Repair of Abdominal Aortic Aneurysms

Abdominal aortic aneurysms are increasingly treated by endovascular aneurysm repair (EVAR), with results comparable to open repair (OR) in the short term and midterm for quality of life (QoL). Data on long-term results are scarce, however, particularly when considering age-related differences. The aim of this study was therefore to highlight the long-term QoL differences between EVAR and OR, with particular attention to the impact of age. To achieve a 5-year follow-up, all standard EVARs and infrarenal ORs, performed electively from January to December 2013, were analyzed and divided into two subgroups: younger patients (YPs), aged <70 years at intervention; and older patients (OPs). QoL was evaluated through a 36-Item Short Form Health Survey (SF-36) questionnaire and a disease-specific questionnaire (DSQ), with attention to sexual activity, surgical access complications, leg weakness/claudication, fatigue, and insomnia. The correlations between age group, type of procedure, and clinical outcomes were analyzed. Of a total of 141 patients submitted to abdominal aortic aneurysm repair (31 deaths, 19 lost), 91 were available for 5-year follow-up analysis (42%-46% YPs, 64 ± 5 years; 49%-54% OPs, 77 ± 3 years). Mean follow-up was 60 ± 10 months. OPs underwent OR in 22% and EVAR in 78%, YPs in 64% and 36%, respectively. Analyzing OPs, OR compared with EVAR showed worsening of QoL in both SF-36 (physical limitations, P = .005; perception of general health, P = .015; mental health, P = .000) and DSQ (sex impairment, 46% vs 5% [P = .004]; leg weakness/claudication, 72% vs 21% [P = .003]; and fatigue, 72% vs 10% [P = .000]). In YPs, QoL was overall comparable between the two techniques, with sexual activity as the unique worsened aspect after OR vs EVAR by DSQ (52% vs 13%; P = .014). Reintervention rate was higher after OR in OPs (36% vs 5%; P = .018) with no difference in YPs (OR, 18%; EVAR, 27%; P = NS). Need for follow-up did not represent an issue for any patient in either group. This study highlights the role of patient age on long-term QoL after OR and EVAR, with worse QoL outcomes after OR in OPs both in SF-36 and DSQ. YPs did not show this differences; however, sexual activity was significantly worsened after OR. In terms of QoL, EVAR should be proposed as a preferential option in OPs. YPs have similar QoL after either procedure; however, the risk of long-term sexual impairment should be considered in the decision-making process.

Sinonasal Quality of Life Outcomes After Extended Endonasal Approaches to the Skull Base.

Introduction Endoscopic endonasal skull base surgery (EESBS) leads to significant alterations in sinonasal anatomy and physiology. However, there is limited data available on quality of life (QOL) outcomes following EESBS. Methods A retrospective review of patients undergoing EESBS from January 2014 to April 2017 was performed. Records were reviewed for clinical history, operative details, and 22-item Sinonasal Outcomes Test (SNOT-22) scores. Unadjusted and adjusted linear regression models were utilized to compare change in SNOT-22 scores from baseline in patients who underwent a simple sella approach (SA) or an extended beyond sella approach (BSA). Results A total of 108 patients were in the SA group, while 61 patients were in the BSA group. SNOT-22 scores were available at baseline and 3 months for 84 patients, while 6-month scores were available for 49 patients. SNOT-22 scores for all patients were not significantly different at 3 months ( p = 0.40) or at 6 months ( p = 0.58). Unadjusted linear regression model did not show an association between the type of approach and change in SNOT-22 score at 3 months ( p = 0.07) and 6 months ( p = 0.28). Adjusted regression model showed a significant decrease in SNOT-22 scores at 3 months ( p = 0.04) for the BSA group, but there was no significant change in SNOT-22 score at 6 months ( p = 0.22). Conclusion Patients undergoing EESBS had no significant change in outcomes at 3 and 6 months. A more extensive BSA was not associated with worse QOL outcomes as measured by SNOT-22.

Patient-reported outcomes in relapsed/refractory multiple myeloma: a systematic review.

We performed a systematic review to quantify the amount of evidence-based data available on patient-reported outcomes (PRO) in Relapsed/Refractory Multiple Myeloma (RRMM) patients and to examine the added value of such studies in supporting clinical decision-making. We conducted a search in PubMed/Medline and the Cochrane Library to identify studies published between January 1990 and May 2017. All studies, regardless of the design, including patients with RRMM and also evaluating PRO were considered. For each study, we collected both PRO and traditional clinical outcomes, such as survival and toxicity information, based on a predefined data extraction form. After having screened 1680 records, 11 studies were identified and these included six randomized controlled trials (RCT). Overall, there were five studies focusing on proteasome inhibitors (PIs), four on immunomodulatory drugs (IMiDs), one on both PIs and IMiDs, and one on monoclonal antibodies. Considering only RCTs, it was found that primary clinical efficacy endpoints frequently favored experimental arms, while (physician-reported) toxicity data did not. However, inspection of PRO data revealed novel information that often contrasted with standard toxicity, for example, by not indicating worse quality of life outcomes or symptom severity for patients enrolled in the experimental arms. There is paucity of evidence-based data regarding the impact of therapies on quality of life and symptom burden of patients with RRMM. Inclusion of PRO in future studies of patients with RRMM is needed to better inform clinical decision-making.

Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases.

This is an update to the review published in the Cochrane Library (2012, Issue 4).It is estimated that 20% to 40% of people with cancer will develop brain metastases during the course of their illness. The burden of brain metastases impacts quality and length of survival. To assess the effectiveness and adverse effects of whole brain radiotherapy (WBRT) given alone or in combination with other therapies to adults with newly diagnosed multiple brain metastases. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase to May 2017 and the National Cancer Institute Physicians Data Query for ongoing trials. We included phase III randomised controlled trials (RCTs) comparing WBRT versus other treatments for adults with newly diagnosed multiple brain metastases. Two review authors independently assessed trial quality and abstracted information in accordance with Cochrane methods. We added 10 RCTs to this updated review. The review now includes 54 published trials (45 fully published reports, four abstracts, and five subsets of data from previously published RCTs) involving 11,898 participants.Lower biological WBRT doses versus controlThe hazard ratio (HR) for overall survival (OS) with lower biological WBRT doses as compared with control (3000 cGy in 10 daily fractions) was 1.21 (95% confidence interval (CI) 1.04 to 1.40; P = 0.01; moderate-certainty evidence) in favour of control. The HR for neurological function improvement (NFI) was 1.74 (95% CI 1.06 to 2.84; P = 0.03; moderate-certainty evidence) in favour of control fractionation.Higher biological WBRT doses versus controlThe HR for OS with higher biological WBRT doses as compared with control (3000 cGy in 10 daily fractions) was 0.97 (95% CI 0.83 to 1.12; P = 0.65; moderate-certainty evidence). The HR for NFI was 1.14 (95% CI 0.92 to 1.42; P = 0.23; moderate-certainty evidence).WBRT and radiosensitisersThe addition of radiosensitisers to WBRT did not confer additional benefit for OS (HR 1.05, 95% CI 0.99 to 1.12; P = 0.12; moderate-certainty evidence) or for brain tumour response rates (odds ratio (OR) 0.84, 95% CI 0.63 to 1.11; P = 0.22; high-certainty evidence).Radiosurgery and WBRT versus WBRT aloneThe HR for OS with use of WBRT and radiosurgery boost as compared with WBRT alone for selected participants was 0.61 (95% CI 0.27 to 1.39; P = 0.24; moderate-certainty evidence). For overall brain control at one year, the HR was 0.39 (95% CI 0.25 to 0.60; P < 0.0001; high-certainty evidence) favouring the WBRT and radiosurgery boost group.Radiosurgery alone versus radiosurgery and WBRTThe HR for local brain control was 2.73 (95% CI 1.87 to 3.99; P < 0.00001; high-certainty evidence)favouring the addition of WBRT to radiosurgery. The HR for distant brain control was 2.34 (95% CI 1.73 to 3.18; P < 0.00001; high-certainty evidence) favouring WBRT and radiosurgery. The HR for OS was 1.00 (95% CI 0.80 to 1.25; P = 0.99; moderate-certainty evidence). Two trials reported worse neurocognitive outcomes and one trial reported worse quality of life outcomes when WBRT was added to radiosurgery.We could not pool data from trials related to chemotherapy, optimal supportive care (OSC), molecular targeted agents, neurocognitive protective agents, and hippocampal sparing WBRT. However, one trial reported no differences in quality-adjusted life-years for selected participants with brain metastases from non-small-cell lung cancer randomised to OSC and WBRT versus OSC alone. None of the trials with altered higher biological WBRT dose-fractionation schemes reported benefit for OS, NFI, or symptom control compared with standard care. However, OS and NFI were worse for lower biological WBRT dose-fractionation schemes than for standard dose schedules.The addition of WBRT to radiosurgery improved local and distant brain control in selected people with brain metastases, but data show worse neurocognitive outcomes and no differences in OS.Selected people with multiple brain metastases from non-small-cell lung cancer may show no difference in OS when OSC is given and WBRT is omitted.Use of radiosensitisers, chemotherapy, or molecular targeted agents in conjunction with WBRT remains experimental.Further trials are needed to evaluate the use of neurocognitive protective agents and hippocampal sparing with WBRT. As well, future trials should examine homogeneous participants with brain metastases with focus on prognostic features and molecular markers.

Central Sensitization Inventory as a Predictor of Worse Quality of Life Measures and Increased Length of Stay Following Spinal Fusion.

Central sensitization is abnormal and intense enhancement of pain mechanism by the central nervous system. Patients with central sensitization may be at higher risk of poor outcomes after spinal fusion. The Central Sensitivity Inventory (CSI) was developed to identify and quantify key symptoms related to central sensitization. In 664 patients who underwent thoracic and/or lumbar fusion, we evaluated retrospectively pretreatment CSI as a predictor of postoperative quality of life measures, length of stay, and discharge status. Preoperative Pain Disability Questionnaire scores, Patient Health Questionnaire-9 scores, and EuroQol-5 Dimensions index scores were significantly worse in patients with preoperative CSI ≥40 compared with patients with preoperative CSI <40 (P < 0.0001 for all). After adjusting for demographic variables, operation duration, and preoperative health status, preoperative CSI was significantly associated with higher postoperative Pain Disability Questionnaire total score (unadjusted P<0.001, adjusted P= 0.009), higher postoperative Patient Health Questionnaire-9 score (unadjusted P < 0.001, adjusted P= 0.001), and lower postoperative EuroQol-5 Dimensions index (unadjusted P < 0.001, adjusted P= 0.001). For each 10-unit increase in CSI, average length of stay increased by 6.4% (95% confidence interval 0.4%-12.6%, P= 0.035). The odds of being discharged home after adjusting for confounders was not statistically related to preoperative CSI (P= 0.0709). Preoperative CSI was associated with worse quality of life outcomes and increased length of stay after spinal fusions. CSI may be an additional measure in evaluating patients preoperatively to better predict successful spinal fusion outcomes.

Concurrent chemoradiotherapy degrades the quality of life of patients with stage II nasopharyngeal carcinoma as compared to radiotherapy

The purpose of this study was to compare the quality of life (QoL) of stage II nasopharyngeal carcinoma (NPC) patients treated with radiotherapy (RT) versus concurrent chemoradiotherapy (CCRT). In a cross-sectional study, these patients were treated with RT (n = 55) or CCRT (n = 51) between June 2008 and June 2013. For all subjects, disease-free survival was more than 3 years. QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questions and the Head and Neck 35 (EORTC QLQ-H&N35) questions. RT had better outcomes than CCRT for global QoL, functional scales, symptom scales of fatigue and insomnia, financial problems, and weight gain. Survivors receiving 1 cycle of concurrent chemotherapy had worse QoL outcomes than survivors receiving 2 cycles of concurrent chemotherapy. Patients receiving 3 cycles of concurrent chemotherapy had the best QoL outcomes. Thus, CCRT adversely affects the QoL of patients with stage II NPC as compared to radiotherapy.

Quality-of-life improvement after endoscopic sinus surgery in patients with obstructive sleep apnea.

Background:There is preliminary evidence that patients with chronic rhinosinusitis (CRS) and comorbid obstructive sleep apnea (OSA) have reduced quality-of-life (QOL) improvements after functional endoscopic sinus surgery (FESS) compared with patients without OSA. The effect of OSA severity on QOL improvement after FESS is unknown.Objectives:To better characterize the QOL improvement after FESS for patients with comorbid OSA and to assess whether QOL improvement is dependent on OSA severity.Methods:This multi-institution, retrospective cohort study evaluated adult patients with CRS who underwent FESS between 2007 and 2015. Preoperative, 1-month, 3-month, 6-month, and 1-year postoperative 22-Item Sino-Nasal Outcome Test scores were used to evaluate QOL. We compared patients without OSA with patients with stratified OSA based on the preoperative apnea-hypopnea index. A multilevel, mixed-effects linear regression model was used for the analysis.Results:Of 480 participants, 83 (17%) had OSA, and 47 of these patients had polysomnography results available for review. Both patients with OSA and patients without OSA reported significant QOL improvement after surgery (p < 0.0001) relative to baseline. In the unadjusted model, the subjects with OSA demonstrated a statistically worse outcome in 22-Item Sino-Nasal Outcome Test scores at each time point (2.4 points higher per time point, p = 0.006). When controlling for covariates, the adjusted model showed no difference in QOL outcome based on OSA status (p = 0.114). When stratified by OSA disease severity, the adjusted model showed no difference in the QOL outcome.Conclusions:Patients with CRS and comorbid OSA had worse QOL outcomes after FESS; however, when controlling for patient factors, there was no difference in QOL outcome. OSA disease severity did not seem to predict QOL improvement after FESS.

Outcomes by area of residence deprivation in a cohort of oral cancer patients: Survival, health-related quality of life, and place of death

Oral cancer patients from lower socio-economic backgrounds have worse outcomes of survival and health related quality of life. The mechanism of cause is not fully understood. The purpose of the paper is to report treatment selection, survival, health related quality of life, cause and place of death in relation to deprivation status. 553 patients treated for oral cancer between 2008 and 2012 were identified from records at University hospital. Mortality was tracked via the Office of National Statistics (ONS) and health-related quality of life was measured using the University Washington quality of life questionnaire (UW-QoLv4). Postcodes of residence at diagnosis were used to obtain index of multiple deprivation (IMD) 2010 scores. Nearly half of the sample (47%) lived in the 'most deprived' IMD 2010 quartile of residential areas in England and such patients when treated with curative intent using surgery with or without adjuvant radiotherapy had worse survival than patients living elsewhere, p=0.01 after adjusting for pathological staging and age group. There were no notable differences by IMD group in cancer being mentioned anywhere in part 1 or part 2 of the death certificate or in place of death. After adjustment for patient and clinical factors patients residing in more deprived areas had worse quality of life outcomes in regard to social-emotional functioning and overall quality of life but not in regard to physical oral function. Addressing inequalities in health care related to deprivation is a priority for patients with oral cancer.

Ovarian function suppression, symptom burden, and quality of life in young women with breast cancer: A prospective study.

515 Background: Recent clinical trial data have demonstrated that ovarian function suppression (OS) in addition to tamoxifen (T) or aromatase inhibitors (AI) can improve breast cancer free survival in young women with hormone positive (HR+) breast cancer. We evaluated the impact of OS on quality of life (QOL) in young women, a population at risk for worse QOL outcomes and survival. Methods: Patient reported symptom and QOL data were collected 1 year after dx as part a cohort study enrolling women newly dx’d with breast cancer age ≤40. Severity of symptoms (Breast Cancer Prevention Trial checklist) was compared between women on OS+T vs. T alone by Fisher’s exact test. For QOL (Cancer Rehabilitation Evaluation System (CARES) physical, psychosocial, sexual subscales), differences in mean scores between groups were compared with t-tests. All were stratified by receipt of chemotherapy. Due to small numbers, women on AIs were excluded. Results: Of444 women with Stage 0-III, HR+ disease on T, 106 (24%) reported ...