Patient-reported Quality Of Life Scores Research Articles

Late Urinary Toxicity and Quality of Life With Pelvic Radiation Therapy for High-Risk Prostate Cancer: Dose-Effect Relations in the POP-RT Randomized Phase 3 Trial

PurposeThe POP-RT phase III randomized trial showed improved biochemical failure-free survival and metastasis-free survival with whole pelvic radiotherapy (WPRT) versus prostate-only radiotherapy (PORT) for high/very high-risk prostate cancer, albeit with worse RTOG late urinary toxicity. We report updated late urinary adverse effects and bladder dose-effect relations within this trial. Materials/MethodsLate urinary toxicity, and cumulative severity of each symptom over the follow-up period was graded using CTCAE v5.0. Bladder dosimetry in 5-Gy increments (V5, V10, V15...V65Gy, V68Gy) in the approved radiotherapy plans was compared for urinary symptoms and overall grade 2+ toxicity. Potential factors influencing urinary toxicity were tested using multivariable logistic regression analysis. Updated urinary quality of life (QOL) scores were compared between the trial arms. ResultsComplete combined data for late urinary symptoms and dosimetry was available for 193/224 patients. At a median follow-up of 75 months, cumulative late urinary CTCAE grade 3 toxicity was low and similar for WPRT and PORT (5.2% vs 4.1%, p=0.49), while grade 2 toxicity was 31.3% vs 22.7% respectively (p=0.12). Cumulative rates of each urinary symptom were similar between both arms. Multivariable analysis with age at diagnosis, known diabetes, tumor stage, trial arm, prior TURP, grade 2+ acute urinary toxicity, low bladder dose (V10Gy) and moderate bladder dose (V40Gy) did not identify any significant association with late urinary toxicity. Urinary QOL scores was similar between both the arms for all the symptoms. ConclusionOver long term follow up, whole pelvic radiotherapy resulted in low (∼5%) and similar grade 3 cumulative urinary toxicity as prostate-only radiotherapy. The long term patient-reported QOL scores were similar. No causative factors affecting the late urinary toxicity were identified.

Quality of life measures and cost analysis of biologic versus synthetic mesh for ventral hernia repair: The Preventing Recurrence in Clean and Contaminated Hernias randomized clinical trial

BackgroundAlthough the most durable method for ventral hernia repairs involves using mesh, whether to use biologic mesh versus synthetic mesh remains controversial. This study aimed to compare synthetic and biologic meshes with respect to patient-reported quality of life scores and costs after ventral hernia repair surgeries. MethodsThis study is part of the Preventing Recurrence in Clean and Contaminated Hernias (PRICE) pragmatic randomized control trial conducted from March 2014 through October 2018. Patients were randomized 1:1 to undergo ventral hernia repair using either a biologic or synthetic mesh. The coprimary outcomes were 2-year changes in Visual Analog Scale, Activities Assessment Scale, Hernia-Related Quality-of-Life Survey, and Short-Form 36 Health Survey (SF-36) quality-of-life scores from repair. The secondary outcome was the overall cost per patient. ResultsAmong the 165 patients included in the study, 82 were randomized to biologic meshes and 83 to synthetic meshes. There were no significant differences in the performance between the 2 mesh types with regard to quality-of-life measures using a mixed model approach. This result was consistent even when performing subgroup analysis based on wound contamination. However, nonparametric tests comparing the differences in quality-of-life measures from preoperative to 24-month postoperative timepoints revealed that the synthetic mesh group showed a greater reduction in disability than biologic mesh for the SF-36 (median [interquartile range] of 20 [5–30] vs 6 [1–20], P = .025). This difference was due to reductions in the physical role limitations (62 [0–100] vs 0 [0–50], P = .018) and the pain (38 [12–50] vs 12 [0–25], P = .012) domains of the SF-36. Overall cost per patient was greater for biologic meshes (mean [95% confidence interval] of $80,420 [$66,485–$94,355] vs $61,036 [$48,946–$73,125], P = .038), regardless of insurance type. ConclusionIn this randomized clinical trial, there were no differences in changes in quality-of-life scores at the 2-year timepoint except for the SF-36, where the synthetic mesh may be associated with less pain and physical role limitations than the biologic mesh. Overall costs per patient were less for synthetic than biologic mesh.

Ferric derisomaltose and Outcomes in the Recovery of Gynecologic oncology: ERAS (Enhanced Recovery After Surgery) (FORGE) – a protocol for a pilot randomised double-blinded parallel-group placebo-controlled study of the feasibility and efficacy of intravenous ferric derisomaltose to correct preoperative iron-deficiency anaemia in patients undergoing gynaecological oncology surgery

IntroductionIron-deficiency anaemia is common in gynaecological oncology patients. Blood transfusions are immunosuppressive and carry immediate and long-term risks. Oral iron replacement remains the standard of care but requires prolonged treatment...

Self- and Caregiver-Reported Participation, Quality of Life, and Related Mood and Behavior Challenges in People Living With Dystrophinopathies

BackgroundPrevious studies of quality of life (QOL), mood, and behavior in muscular dystrophy focus on caregiver perceptions. This cross-sectional study aims to determine the prevalence of clinically significant mood and behavior problems by both patient and caregiver report and assess relationship between mood/behavior and QOL. MethodsForty-one patients with dystrophinopathies (Duchenne muscular dystrophy [DMD] and Becker muscular dystrophy [BMD]) were recruited through the University of Virginia Neuromuscular Clinic. Each patient and caregiver dyad completed questionnaires, including the Behavior Assessment System for Children, 2nd Edition (BASC-2); the Pediatric Quality of Life Inventory for DMD (PedsQL-DMD); Children's Depression Inventory, 2nd Edition; and Screen for Child Anxiety Related Disorders. ResultsPersons with dystrophinopathies rated most of their behavior and adaptive skills similarly to the general population. Sixty-four percent of parent assessments rated clinically significant problems on the BASC-2. Worse BASC-2 scores for self- and parent assessments correlated with lower (worse) scores in the Worry and Communication PedsQL domains. Patient-reported QOL scores were higher than parent-reported scores in each domain except Worry. ConclusionsIndividuals with DMD/BMD rate their adaptive skills, behavioral symptoms, externalizing and internalizing problems, and school problems more positively than parents/caregivers. Obtaining self-report data is a worthwhile endeavor that can add value to intervention planning, with the ultimate goal of optimizing QOL.

Acid exposure time better predicts outcomes following anti-reflux surgery than DeMeester score.

Criteria to diagnose gastroesophageal reflux disease (GERD) vary. The American Gastroenterology Association (AGA) 2022 Expert Review on GERD focuses on acid exposure time (AET) rather than DeMeester score from ambulatory pH testing (BRAVO). We aim to review outcomes following anti-reflux surgery (ARS) at our institution, grouped by differing criteria for the diagnosis of GERD. A retrospective review of a prospective gastroesophageal quality database was performed for all patients undergoing evaluation for ARS with preoperative BRAVO ≥ 48h. Group comparisons were made using two-tailed Wilcoxon rank-sum and Fisher's exact tests and two-tailed statistical significance of p < 0.05. Between 2010 and 2022, 253 patients underwent an evaluation for ARS with BRAVO testing. Most patients (86.9%) met our institution's historical criteria: LA C/D esophagitis, Barrett's, or DeMeester ≥ 14.72 on 1+ days. Fewer patients (67.2%) met new AGA criteria: LA B/C/D esophagitis, Barrett's, or AET ≥ 6% on 2+ days. Sixty-one patients (24%) met historical criteria only, with significantly lower BMI, ASA, less hiatal hernias, and less DeMeester and AET-positive days, a less severe GERD phenotype. There were no differences between groups in perioperative outcomes or % symptom resolution. Objective GERD outcomes (need for dilation, esophagitis, and postop BRAVO) were equivalent between groups. Patient-reported quality of life scores, including GERD-HRQL, RSI, and Dysphagia Score did not differ between groups from preop through 1year postop. Those who met our historical criteria only reported significantly worse RSI scores (p = 0.03) and worse GERD-HRQL scores at 2years postop, though not statistically significant (p = 0.07). Updated AGA GERD guidelines exclude a portion of patients who historically would have been diagnosed with and surgically treated for GERD. This cohort appears to have a less severe GERD phenotype but equivalent outcomes up to 1year, with more atypical GERD symptoms at 2years postop. AET may better define who should be offered ARS than DeMeester score.

Nasal Airflow Dynamics Before and After Septorhinoplasty for Correction of Cleft Lip Nasal Deformity: A Single Patient Case Report

Background: Unilateral cleft lip nasal deformity (uCLND) creates multiple sites of nasal airway obstruction, impacting patients’ quality of life. Surgical restoration of function remains technically challenging and complex. Objectives: This is a single patient case report to determine consistency of patient’s subjective perception of nasal outcomes after septorhinoplasty with objective assessments, and effectiveness of standard surgical techniques in targeting sites of greatest nasal anatomical obstruction. Method: Patient-reported quality of life (QOL) measures were collected. Pre- and post-surgery radiographic images of a patient with uCLND were obtained for computational fluid dynamics (CFD) modeling of patient-specific nasal function. Objective assessments were obtained using rhinomanometry and CFD. CFD-derived localized resistance at multiple cross-sectional segments were determined and used to identify greatest nasal obstructive sites. Results: Patient-reported QOL scores improved by 20 to 73 points. CFD-calculated bilateral resistance decreased from 0.155 to 0.061 Pa.s/ml, cleft-side resistance from 0.407 to 0.091 Pa.s/ml, and non-cleft-side from 0.228 to 0.120 Pa.s/ml. Rhinomanometry showed similar decreases in resistance. On the cleft side, 25 identified sites of greatest obstruction decreased to 15 sites post-surgery; on the non-cleft side, 23 sites of greatest obstruction decreased to 16 sites post-surgery. Conclusion: Results suggest improvement in nasal patency after septorhinoplasty. Additional greatest obstructive sites in the post-surgical airway were mostly around the superior airway.

Recognizing Neuropathic Pain as a Symptom of Charcot-Marie-Tooth Disease that impacts Quality of Life (P14-8.005)

<h3>Objective:</h3> This study utilizes patient-reported data to explore under-recognized contributors to disease burden in Charcot-Marie Tooth (CMT) disease. The goal of this study is to evaluate the psychosocial impact of pain on patients with CMT. <h3>Background:</h3> CMT is the most commonly inherited neurological disorder, with a prevalence of 1/2,500. With no definitive cure or approved pharmacologic options, treatment focuses on rehabilitation and psychosocial support. <h3>Design/Methods:</h3> Adults with CMT (n=224) participated in a mobile survey consisting of questions assessing pain quality and psychosocial factors. Validated PROMIS scales generated T-scores describing the degree of neuropathic pain, life satisfaction, and social isolation. Statistical analysis included Pearson’s product-moment correlation and Wilcoxon rank sum tests. <h3>Results:</h3> A majority of respondents (81.6%) reported pain in the past 7 days, with a mean (SD) severity of 4.2±2.5 out of 10. Females aged &lt;65 scored highest on the pain scale (5.01±2.45) and males aged &gt;65 scored lowest (3.22±2.56). The majority of respondents experienced neuropathic-type pain (63.95%). Life satisfaction and social isolation scores among this population did not significantly differ from the general public, but pain significantly impacted patient-reported quality of life scores. Life satisfaction scores decreased with increasing pain severity (r=−0.253, p=0.00059). Social isolation was correlated with pain severity (r=0.167, p=0.02597). Compared to patients with non-neuropathic pain, patients with neuropathic pain reported increased social isolation (p=0.005967) and decreased life satisfaction (p=0.03558). <h3>Conclusions:</h3> These patient-reported data reveal neuropathic pain as a contributor to disease burden in patients with CMT. Our findings suggesting that patients with severe, neuropathic-type pain experience heightened social isolation and diminished life satisfaction indicate that pain may be an unmet target in improving quality of life in patients with CMT. <b>Disclosure:</b> Miss Chang has nothing to disclose. Ms. Imossi has nothing to disclose. Dr. Gelman has nothing to disclose. Mrs. Moore has nothing to disclose. Mr. Moore has received personal compensation for serving as an employee of Hereditary Neuropathy Foundation . Mrs. Aldrich has received personal compensation for serving as an employee of Hereditary Neuropathy Foundation. Dr. Thomas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pharnext. Dr. Thomas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acceleron. Dr. Thomas has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Spinal Cord Medicine. Dr. Thomas has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Gravel &amp; Shae. Dr. Thomas has a non-compensated relationship as a Board Member, Metro New Jersey with National MS Society that is relevant to AAN interests or activities. Dr. Thomas has a non-compensated relationship as a Board Member with American Paraplegia Society that is relevant to AAN interests or activities.

Palbociclib plus letrozole as treatment for postmenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate: An expanded access study in Australia and India.

Palbociclib was approved in the United States in 2015 to treat estrogen receptor-positive/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). This study evaluated outcomes and safety in patients treated with palbociclib in Australia and India with hormone receptor-positive (HR+)/HER2- ABC before palbociclib became commercially available. Postmenopausal women (≥18 years) with HR+/HER2- ABC who were appropriate candidates for letrozole therapy received palbociclib 125mg once daily for 21 days followed by 7 days off, and letrozole 2.5mg once daily (continuous). Safety, tumor response, and patient-reported outcomes (Australian cohort) were evaluated. In total, 252 patients received palbociclib plus letrozole (Australia, n=152; India, n=100). More patients in the Australian versus Indian cohort had received prior chemotherapy (advanced/metastatic setting: 45.9%vs. 32.0%), endocrine therapy (advanced/metastatic setting: 63.2%vs. 54.3%), and advanced/metastatic therapies (61.8%vs. 31.0%). The most frequently reported all-grade palbociclib-related treatment-emergent adverse events were neutropenia (66.7%), fatigue (35.3%), and stomatitis (26.6%); grade 3/4 neutropenia was reported as palbociclib-related in 62.7% of patients. Febrile neutropenia was reported in six patients (2.4%). Eight patients (3.2%) discontinued because of an adverse event. The objective response rate was 19.4% (95% CI, 14.7%-24.9%) overall and 2.3% in Australian patients with ≥2 lines of prior therapy for metastatic disease. Patient-reported quality of life scores were maintained throughout the study. In an expanded access setting in Australia and India, palbociclib plus letrozole was well tolerated in patients with HR+/HER2- ABC, with a safety profile consistent with previous reports.

Conventional vs. Hypofractionation Radiation for High-Risk Prostate Cancer Patients (CHIRP): 24 Months Patient-Reported Quality of Life Outcomes of the Randomized Phase II CHIRP Trial

<h3>Purpose/Objective(s)</h3> The CHIRP study is a randomized phase II clinical trial that compared clinical outcomes between standard fractionation (78Gy in 39 fractions) and hypofractionation (68Gy in 25 fractions) in the treatment of high-risk prostate cancer. We performed a quality of life (QoL) sub-study to assess patient-reported outcomes up to 24 months post therapy. <h3>Materials/Methods</h3> Men with high-risk prostate cancer (stage T3/T4 and/or PSA ≥20 ng/ml and/or Gleason score 8 to 10) without clinical or radiological evidence of nodal or distant metastases were included in the CHIRP trial. QoL data was collected through the Expanded Prostate Cancer Index Composite (EPIC) and the Short Form 12 (SF12) health-related QoL questionnaire at baseline, 3 months, 6 months, 12 months, 18 months and 24 months post treatment. We assessed change from baseline (follow-up score minus bassline score) to account for differences in baseline comorbidities. Analysis of Variance (ANOVA), using a significance level of 0.05, was used to identify differences between the two groups. <h3>Results</h3> A total of 96 participants were included in the QoL sub-study, with 49 patients in the hypofractionation arm and 47 patients in the standard fractionation arm. Baseline urinary function favored patients in the standard arm (<i>P</i> = 0.04). All other baseline QoL parameters were balanced. At 3 months (<i>P</i> = 0.155), 6 months (<i>P</i> = 0.197), 12 months (<i>P</i> = 0.016) and 18 months (<i>P</i> = 0.120) post treatment, the bowel bother scores trended to favor the standard fractionation arm, and was statistically significant at 12 months (<i>P</i> = 0.016). At 6 months (<i>P</i> = 0.187), 12 months (<i>P</i> = 0.063) and 18 months (<i>P</i> = 0.017) post treatment, the SF12 physical component score (PCS) trended to favor the hypofractionation arm, and was statistically significant at 18 months (<i>P</i> = 0.017). At 24 months, there were no differences in QoL scores between the 2 groups. <h3>Conclusion</h3> The patient-reported QoL scores were similar between the standard fractionation arm (78Gy in 39 fractions) and the hypofractionation arm (68Gy in 25 fractions) up to 24 months after radiotherapy. Early statistically significant differences in bowel bother and physical component score were no longer present at 24 months.

Ultrasound screening for abdominal aortic aneurysm in high-risk women

BackgroundPopulation-wide ultrasound screening programmes for abdominal aortic aneurysm (AAA) for men have already been established in some countries. Women account for one third of aneurysm-related mortality and are four times more likely to experience an AAA rupture than men. Whole-population screening for AAA in women is unlikely to be clinically or economically effective. The aim of this study was to determine the outcomes of a targeted AAA screening programme for women at high risk of AAA.MethodWomen aged 65–74 years deemed at high risk of having an AAA (current smokers, ex-smokers, or with a history of coronary artery disease) were invited to attend ultrasound screening (July 2016 to March 2019) for AAA in the Female Aneurysm screening STudy (FAST). Primary outcomes were attendance for screening and prevalence of AAA. Biometric data, medical history, quality of life (QoL) and aortic diameter on ultrasound imaging were recorded prospectively.ResultsSome 6037 women were invited and 5200 attended screening (86.7 per cent). Fifteen AAAs larger than 29 mm were detected (prevalence 0.29 (95 per cent c.i. 0.18 to 0.48) per cent). Current smokers had the highest prevalence (0.83 (95 per cent c.i. 0.34 to 1.89) per cent) but lowest attendance (75.2 per cent). Three AAAs greater than 5.5 cm were identified and referred for consideration of surgical repair; one woman underwent repair. There was a significant reduction in patient-reported QoL scores following screening.ConclusionA low prevalence of AAA was detected in high-risk women, with lowest screening uptake in those at highest risk. Screening for AAA in high-risk women may not be beneficial.

Is There a Disadvantage to Early Physical Therapy After Multiligament Surgery for Knee Dislocation? A Pilot Randomized Clinical Trial.

Multiligament knee injuries, though rare, can be profoundly disabling. Surgeons disagree about when to initiate rehabilitation after surgical reconstruction due to the conflicting priorities of postoperative stability and motion. (1) Does early or late initiation of physical therapy after multiligament knee surgery result in fewer postoperative manipulations? (2) Does early versus late physical therapy compromise stability postoperatively? (3) Does early initiation of physical therapy result in improved patient-reported outcomes, as measured by the Multi-ligament Quality of Life (ML-QOL) score? Between 2011 and 2016, 36 adults undergoing multiligament repair or reconstruction were prospectively enrolled in a randomized controlled trial and randomized 1:1 to either early rehabilitation or late rehabilitation after surgery. Eligibility included those with an injury to the posterior cruciate ligament (PCL) and at least one other ligament, as well as the ability to participate in early rehabilitation. Patients who were obtunded or unable to adhere to the protocols for other reasons were excluded. Early rehabilitation consisted of initiating a standardized physical therapy protocol on postoperative day 1 involving removal of the extension splint for quadriceps activation and ROM exercises. Late rehabilitation consisted of full-time immobilization in an extension splint for 3 weeks. Following this 3-week period, both groups engaged in the same standardized physical therapy protocol. All surgical reconstructions were performed at a single center by one of two fellowship-trained sports orthopaedic surgeons, and all involved allograft Achilles tendon PCL reconstruction. When possible, hamstring autograft was used for ACL and medial collateral ligament reconstructions, whereas lateral collateral ligament and posterolateral reconstruction was performed primarily with allograft. The primary outcome was the number of patients undergoing manipulation during the first 6 months. Additional outcomes added after trial registration were patient-reported quality of life scores (ML-QOL) at 1 year and an objective assessment of laxity through a physical examination and stress radiographs at 1 year. One patient from each group was not assessed for laxity or ROM at 1 year, and one patient from each group did not complete the ML-QOL questionnaires. No patient crossover was observed. With the numbers available, there was no difference in the use of knee manipulation during the first 6 months between the rehabilitation groups: 1 of 18 patients in the early group and 4 of 18 patients in the late group (p = 0.34). Similarly, there were no differences in knee ROM, stability, or patient-reported quality of life (ML-QOL) between the groups at 1 year. With the numbers available in this study, we were unable to demonstrate a difference between early and late knee rehabilitation with regard to knee stiffness, laxity, or patient-reported quality of life outcomes. The results of this small, randomized pilot study suggest a potential role for early rehabilitation after multiligament reconstruction for knee dislocation, which should be further explored in larger multi-institutional studies. Level II, therapeutic study.

Systematic review of outcomes for endoscopic sinus surgery and subsequent aspirin desensitization in aspirin-exacerbated respiratory disease.

ObjectiveTo review and evaluate outcomes of patients with aspirin-exacerbated respiratory disease (AERD) following endoscopic sinus surgery and subsequent aspirin desensitization.MethodsElectronic searches of OVID MEDLINE (1948 to September 10, 2019), EMBASE (1980 to September 10, 2019), and PubMed were performed on September 10, 2019. A systematic review of the literature was performed using the 2009 PRISMA guidelines. Studies with both preoperative and postoperative data for patients with AERD who underwent sinus surgery and aspirin desensitization were considered appropriate for inclusion. Publications were written in English and included patients aged 18 years or older.ResultsSix studies met inclusion criteria for this systematic review. The primary outcome measure was change in symptom profile measured by patient-reported quality of life scores. The results demonstrate statistically significant improvement in symptoms following endoscopic sinus surgery, with sustained improvement following aspirin desensitization. Revision surgery rates were significantly lower in patients maintained on aspirin therapy.ConclusionThis review suggests that surgery followed by aspirin desensitization results in improvement in both subjective and objective outcome measures. The adjunctive use of aspirin desensitization allows for long-term stability in symptom scores. Recurrence of polyps and worsening symptoms requiring revision surgery occurs when aspirin maintenance therapy is interrupted.

Dosimetric Predictive Models for Urinary and Rectal Toxicities after Prostate Stereotactic Body Radiotherapy Assessed from the Expanded Prostate Cancer Index Composite Patient-reported Quality of Life

The underlying correlations between treatment planning parameters and treatment toxicities are greatly needed for prostate SBRT. We aimed to assess dosimetric quantities and their associations with patient-reported quality of life (QOL) using advanced machine learning techniques. One hundred one prostate SBRT patients were pooled and analyzed. Patients received 40 Gy in 5 fractions on a LINAC using an IMRT arc therapy delivery technique. Patient-specific differential dose-volume histograms (dDVHs, in 1 Gy dose bins from 0 to maximum doses) for rectum and bladder were extracted from the treatment planning system. Other pre-selected quantities, such as planning target volume (PTV) /rectal/bladder volumes and maximum doses, conformality index, etc. were also considered as potential predictors. Patient-reported QOL scores from the Expanded Prostate Cancer Index Composite (EPIC-26) were collected at consultation (baseline) and at 3- and 12- months post-SBRT. Patients were grouped by their score changes (decrement/no change/increment) according to minimally important difference score thresholds of 4, 5, and 6 in bowel, urinary irritative and urinary incontinence domains, respectively. Ensemble machine learning methods including Gradient Boosting Decision Tree (GBDT) were applied to interrogate each dose bin of the dDVHs and the other potential predictors to evaluate their relationships with QOL changes. The most plausible dosimetric features and their importance were derived from the reduction of square loss after tree node splitting using the GBDT. The Pearson correlation tests were performed on final selected dosimetric features. Multivariable linear logistic regression models were then constructed using the selected top features. The performance of predictive models was evaluated using area under the curve (AUC) using 5-fold cross validation. An independent cohort of 15 patients were used to validate the predictive models. At 12 months, bladder dosimetry demonstrated predictive ability for urinary irritation and incontinence symptoms with AUCs of 0.72 and 0.81, respectively. AUC = 0.65 was observed for rectal toxicities. Predictive models, constructed using top 5, 10 and 20 most plausible dosimetric parameters, yielded AUCs of 0.72, 0.76, 0.75; 0.62, 0.8 and 0.8; and 0.73, 0.76, 0.73 for urinary irritation, incontinence and bowel toxicity, respectively. We demonstrated the correlations between dosimetric quantities and patient-reported outcomes for bladder toxicities, dosimetric metrics had less predictive ability for rectal toxicity at 12 months after prostate SBRT. The linear models built on top 10 dosimetric parameters achieved great performances to predict toxicities. The identified dosimetric metrics and the multivariable linear models can be used to refine planning guidelines towards personalized treatment.

Differentiation of Clinical Patterns Associated With Rhinologic Disease

Common rhinologic diagnoses have similar presentations with a varying degree of overlap. Patterns may exist within clinical data that can be useful for early diagnosis and predicting outcomes. To explore the feasibility of artificial intelligence to differentiate patterns in patient data in order to develop clinically-meaningful diagnostic groups. A cross-sectional study of prospectively-acquired patient data at a tertiary rhinology clinic was performed. Data extracted included objective findings on nasal endoscopy, patient reported quality of life (PRQOL) instrument ratings, peripheral eosinophil fraction, and past medical history. Unsupervised non-hierarchical cluster analysis was performed to discover patterns in the data using 22 input variables. A total of 545 patients were analyzed after application of inclusion and exclusion criteria yielding 7 unique patient clusters, highly dependent on PRQOL scores and demographics. The clusters were clinically-relevant with distinct characteristics. Chronic rhinosinusitis without nasal polyposis (CRSsNP) was associated with two clusters having low frequencies of asthma and low eosinophil fractions. Chronic rhinosinusitis with nasal polyposis (CRSwNP) was associated with high frequency of asthma, mean (standard deviation [SD]) NOSE scores of 66 (19) and SNOT-22 scores of 41 (15), and high eosinophil fractions. AR was present in multiple clusters. RARS was associated with the youngest population with mean (SD) NOSE score of 54 (23) and SNOT-22 score of 41 (19). Broader consideration of initially available clinical data may improve diagnostic efficiency for rhinologic conditions without ancillary studies, using computer-driven algorithms. PRQOL scores and demographic information appeared to be useful adjuncts, with associations to diagnoses in this pilot study.

Evaluation for Racial Disparities in Patients Presenting for Sports Medicine Knee Surgery

Objectives:Several clinical studies have outlined differences in clinical outcomes and access to care when controlling for race. No published clinical study has ever investigated healthcare disparities between Black and White patients presenting for sports medicine knee surgery. The purpose of this study is to determine if the racial disparities described in the literature for total joint arthroplasty and spine surgery are also preset in patients presenting for sports medicine knee surgery. Our first hypothesis is that Black patients presenting for sports medicine knee surgery have worse baseline patient-reported quality of life scores, pain, and function compared to White patients. Our second hypothesis is that Black patients have more disease severity at the time of surgery compared to their White counterparts.Methods:We prospectively collected patient-reported outcomes (PROs), disease severity, and treatment utilizing the [BLINDED DATABASE]. Patient race, body mass index (BMI) and insurance were retrospectively collected from the electronic medical record (EMR). We included consecutive patients undergoing both knee arthroscopy (partial meniscectomy) and anterior cruciate ligament (ACL) reconstruction surgery. We excluded patients undergoing other chondral replacement or complex ligamentous procedures (e.g. MPFL reconstruction, multiligamentous knee surgery, etc). Univariate ("unadjusted") analysis was utilized to compare differences between groups with ANOVA, Kruskal Wallis Testing and Pearson’s Chi-square testing. Subsequently, a multivariate analysis model was constructed to control for confounding variables within Black patients vs White patients in order to evaluate for racial disparities in baseline PROs and disease severity. All testing was considered significant at the 5% level.Results:We enrolled a total of 4,557 patients for this study. In the arthroscopy group (APM) we enrolled 3086 total patients. In this group there were 2593 White patients and 408 Black patients. Eighty-five patients identified as “Other”. In the ACL reconstruction (ACLR) group there were 1471 patients. In this group 1197 patients identified as White, 202 patients identified as Black and 72 patients identified as “Other”. Univariate analysis in the APM group demonstrated racial disparities in certain key metrics. BMI was worse in Black patients (32.4) compared to White patients (30.3) (p < 0.001). Both KOOS pain (41.7 versus 47.2; p < 0.001) and KOOS function (51.5 versus 58.0; p < 0.001) were worse in Black patients compared to White patients. A larger portion of Black patients were current smokers compared to White patients (16.% versus 10%; p < 0.001). Baseline VR12 scores were also lower in Black versus White patients (48.4 versus 55.9, p 0.001). Multivariate analysis revealed no racial disparities for any baseline patient-reported outcome measure (pain, function, or quality of life). This is a result of Black patients being more likely to present with higher BMI, current smoker status, fewer years of formal education, and Medicaid insurance. No significant differences between Black and White patients were noted with respect to disease severity (intraoperative pathology; i.e. worse chondral grade, compartments involved, meniscus tear severity). Our ACLR group demonstrated similar findings on univariate analysis with Black patients more likely to have Medicare/Medicaid than commercial insurance, a higher BMI, smoking history and a lower VR12 score compared to White patients. Linear regression analysis demonstrates that age, gender (female worse), BMI, years of education, smoking status and insurance are all significant drivers of outcome for KOOS pain. With respect to additional intra-articular pathology at the time of ACL tear, female sex and increasing years of education were at an increased odds of having a complete meniscal tear. Neither race or insurance status were significant drivers of concomitant intra-articular findings in ACL tear patients.Conclusions:There is no statistically significant racial disparity in baseline patient reported outcomes with respect to patients presenting for sports medicine knee surgery when controlling for important covariates. Black patients did present with worse subjective KOOS knee pain and functional scores, however, when possible confounding variables were controlled for in a multivariable analysis, there was no difference between the White and Black cohorts. The results of this study show that there may be modifiable risk factors that affect outcomes of patients irrespective of racial background. Addressing factors such as BMI, smoking status and healthcare literacy may help to improve outcomes for patients. Further research into interventions to correct these risk factors is needed.

Target motion mitigation promotes high-precision treatment planning and delivery of extreme hypofractionated prostate cancer radiotherapy: Results from a phase II study

Background and purposeWhile favourable long-term outcomes have been reported in organ-confined prostate cancer treated with 5 × 7–8 Gy extreme hypofractionation, dose escalation to 5 × 9–10 Gy improved local control but was associated with unacceptable rates of late rectal and urinary toxicities. The purpose of this study was to explore the feasibility of intra-fractional prostate immobilization in reducing toxicity, to promote dose escalation with extreme hypofractionated radiotherapy in prostate cancer. Material and methods207 patients received 5 consecutive fractions of 9 Gy. An air-inflated (150 cm3) endorectal balloon and an intraurethral Foley catheter with 3 beacon transponders were used to immobilize the prostate and monitor intra-fractional target motion. VMAT-IGRT with inverse dose-painting was employed in delivering the PTV dose and in sculpting exposure of normal organs at risk to fulfil dose-volume constraints. ResultsIntroduction of air-filled balloon induced repeatable rectum/prostate complex migration from its resting position to a specific retropubic niche, affording the same 3D anatomical configuration daily. Intra-fractional target deviations ≤1 mm occurred in 95% of sessions, while target realignment in ≥2 mm deviations enabled treatment completion as scheduled. Nadir PSA at median 54 months follow-up was 0.19 ng/mL, and bRFS was 100%, 92.4% and 71.4% in low-, intermediate- and high-risk categories, respectively. Late Grade 2 GU and GI toxicities were 2.9% and 2.4%, respectively. No adverse changes in patient-reported quality of life scores were observed. ConclusionThe unique spatial configuration of this prostate motion mitigation protocol enabled precise treatment planning and delivery that optimized outcomes of ultra-high 5 × 9 Gy hypofractionated radiotherapy of organ-confined prostate cancer.

Clinical and genetic determinants of toxicity and quality-of-life (QOL) outcomes for SBRT in Asian prostate cancer.

95 Background: There is limited data on clinical and patient-reported quality of life (PRO-QOL) outcomes after stereotactic body radiotherapy (SBRT) in Asian men with localised prostate cancer. Demographic differences with regard to PRO-QOL outcomes may be due to variation in germline genetics. We therefore conduct a single-institution prospective phase II trial of prostate SBRT in Asian men with intermediate-risk prostate cancers (IR-PCa). Additionally, we investigated association of dosimetric and genetic factors with outcomes. Methods: Patients with biopsy-proven NCCN-defined IR-PCa were recruited. SBRT was delivered at 36.25 Gy/5fr using a Linac-based RapidArc technique. Adverse events (AEs) were assessed with CTCAEv4.0 and IPSS; PRO-QOL assessed using the EPIC instrument at baseline, 1 and 2-year post-SBRT. Germline genetics were profiled by whole exome sequencing (30X). Results: 65 patients were recruited over the period of 2014-2016 (median follow-up = 30 mo). We observed 4 acute ≥G2 gastrointestinal (GI) events (3 fecal urgency, 1 diarrhea). Longitudinal assessment of acute genitourinary (GU) events by IPSS showed worsened symptoms that peaked at 1 wk post-SBRT (44.6% vs 6.2% at 1 mo for men reporting scale upgrade). There was no significant association between acute GU effects (by IPSS) and dosimetric parameters of the irradiated urethra and bladder. PRO-QOL scores demonstrated minimal change over time across all domains; however, sexual bother in the top 50th percentile subgroup at baseline indicated ≥20% worsening of scores for 10/32 (31%) at 12 mo and 5/12 (42%) at 24 mo; which was not associated with Dosemax to the penile bulb (P = 0.1). We observed a high frequency of germline mutations in DNA repair genes (N = 10; 15.4%), including two BRCA2 stop-gain and frameshift mutations. In particular, BRCA2 mutations were detected in 2 of 4 cases with ≥G2 GI effects, independent of rectal dose. Conclusions: While prostate SBRT is well tolerated in our Asian cohort, there appears to be demographic differences in sexual bother compared to Caucasian cohorts. Interestingly, we observed a higher than expected prevalence for germline mutations in DNA repair genes, which may predict treatment response. Clinical trial information: NCT02313298.

Racial disparity in oncologic and quality‐of‐life outcomes in patients with locally advanced head and neck squamous cell carcinomas enrolled in a randomized phase 2 trial

To better understand patient-reported quality of life (PRQOL) for patients with head and neck cancer, PRQOL scores were collected in a clinical trial. Patients were randomized to arm A (70 Gy of radiation with cisplatin) or arm B (70 Gy of radiation with cisplatin plus erlotinib at 150 mg daily). PRQOL scores were measured on days -7 (arm B only), 0, 30, and 180 with the University of Washington Quality of Life Questionnaire. Associations with clinical factors and outcomes were explored with linear mixed, logistic, and Cox regression models. One hundred eighty-nine patients (97 in arm A and 92 in arm B) consented to PRQOL collection. Patients were balanced apart from more females in arm A (20 [21%] vs 8 [9%]; P = .02). There were 17 black patients (18%) in arm A and 12 (13%) in arm B (P = .39). There was no change in the mean scores in arm B from day -7 to day 0 (P = .36). Scores were lower in both arms at day 30 (P for both < .0001), with no difference by arm (P = .10). Scores on day 180 remained lower for arm A (-6.79; 95% confidence interval [CI], -12.6 to -1.0; P = .02). In arm B, this difference was not significant, and this suggested that the scores had returned to the baseline by day 180 (P = .73). After adjustments for potential confounders, black race was an independent predictor for inferior scores (-11.4; 95% CI, -16.84 to -5.94; P < .0001), complete response rates (odds ratio, 0.34; 95% CI, 0.12-0.91; P = .03), and overall survival (hazard ratio, 3.71; 95% CI, 1.63-8.47; P < .01). PRQOL scores predictably worsened during and improved after chemoradiation. Black patients had inferior PRQOL and overall survival. Cancer 2018;124:2841-2849. © 2018 American Cancer Society.

Dosimetric Predictors for Quality of Life After Prostate Stereotactic Body Radiation Therapy via Deep Learning Network

Potential correlation between the dosimetric quantities and the clinical outcome may exist, and remains a challenging task in clinical outcome assessment. To account for complex linear/non-linear relationships, we developed a Deep Neural Network (DNN) model that transforms the patient geometry and treatment parameters into corresponding quality metrics. The purpose of this work is to predict clinical outcome, i.e., patient-reported quality-of-life (QOL) in urinary and bowel domains, via novel DNN for prostate stereotactic body radiotherapy (SBRT). The DNN model was developed to predict clinical QOL scores assessed from the Expanded Prostate Cancer Index Composite (EPIC-26) at the time between consultation and initial treatment (baseline) and at the completion of treatment and every 3 months up to 30 months. Patient geometry and dose-volume histogram parameters were extracted from Eclipse treatment plans for a group of 86 patients. The evaluated dosimetric parameters included: prostate/bladder/rectal volumes; V100 (volume receiving 100% prescription dose), V50, V80, V90; maximum/mean doses to prostate/bladder/rectum. The data was annotated with each patient’s subjective quality metrics documented at 3-month intervals. The annotated data was then split between training and test cohorts as 75% and 25%, respectively. This corresponded to a group of 60 patients used for training purposes, while the remaining 26 patients were used for evaluation purposes. The training data was fed to the DNN, where a series of weights and biases applied to the plan parameters were optimized through stochastic gradient descent (SGD), using an adaptive sub-gradient method with dynamic learning rates. The number of neurons in the hidden layers was optimized for the best result, ultimately settling at 200. This learning process minimized a loss function between network-predicted clinical outcomes and the patient-reported ground-truth, by iterating over randomly sampled sets of training data. The DNN successfully predicts QOL scores. Training on the dosimetric metrics: V50, V80 and V90 values of the rectum, 90.8% accuracy were observed in predicting the QOL in rectal domain. The same metrics in urinary domain yielded 87.3% accuracy for urinary functions. Large prostate volume predicted QOL decrements in urinary functions at 92% accuracy. When QOL scores at 1-year follow-up time were included in network training along with rectum values (V50, V80, and V90), the accuracy of the neural network-predicted QOL values at 3, 6, and 9 months follow-up were 94%, 92.5%, and 89.2%, respectively. The deep learning network was adapted to predict the patient-reported QOL scores versus dosimetric parameters for prostate SBRT. Our results showed that neural network was able to predict the QOL scores for each of the patients with +/- 5 points, which supports the model’s usage in radiotherapy.

Chordee and Penile Shortening Rather Than Voiding Function Are Associated With Patient Dissatisfaction After Urethroplasty

To identify factors that predict patient satisfaction after urethroplasty by prospectively examining patient-reported quality of life scores using 3 validated instruments. A 3-part prospective survey consisting of the International Prostate Symptom Score (IPSS), the International Index of Erectile Function (IIEF) score, and a urethroplasty quality of life survey was completed by patients who underwent urethroplasty preoperatively and at 6 months postoperatively. The quality of life score included questions on genitourinary pain, urinary tract infection (UTI), postvoid dribbling, chordee, shortening, overall satisfaction, and overall health. Data were analyzed using descriptive statistics, paired t test, univariate and multivariate logistic regression analyses, and Wilcoxon signed-rank analysis. Patients were enrolled in the study from February 2011 to December 2014, and a total of 94 patients who underwent a total of 102 urethroplasties completed the study. Patients reported statistically significant improvements in IPSS (P < .001). Ordinal linear regression analysis revealed no association between age, IPSS, or IIEF score and patient satisfaction. Wilcoxon signed-rank analysis revealed significant improvements in pain scores (P = .02), UTI (P < .001), perceived overall health (P = .01), and satisfaction (P < .001). Univariate logistic regression identified a length >4 cm and the absence of UTI, pain, shortening, and chordee as predictors of patient satisfaction. Multivariate analysis of quality of life domain scores identified absence of shortening and absence of chordee as independent predictors of patient satisfaction following urethroplasty (P < .01). Patient voiding function and quality of life improve significantly following urethroplasty, but improvement in voiding function is not associated with patient satisfaction. Chordee status and perceived penile shortening impact patient satisfaction, and should be included in patient-reported outcome measures.