Quality Of Life Metrics Research Articles

271. A biopsychosocial approach in the management of chronic low back pain: 2-year outcomes

BACKGROUND CONTEXT Back pain is a pervasive public health problem with two-thirds of the population experiencing it at some point in their lives and associated with significant costs for both treatment and associated loss of productivity. When pain is persistent, traditional single service approaches to treating back pain may be insufficient, as they do not address the psychosocial factors which frequently impact an individual's pain experience. PURPOSE This study aims to present effect of multidisciplinary program using patient reported outcomes measures in this approach to chronic low back pain (CLBP) management. STUDY DESIGN/SETTING The Cleveland Clinic operates an interdisciplinary pain program to care for patients with CLBP, called Back on TREK (BoT). PATIENT SAMPLE First 168 patients to graduate in BoT over a 2-year period (2016-2018). OUTCOME MEASURES Patient-reported outcomes were systematically collected at the point of care through a patient-entered data collection platform which integrates data into the electronic medical record and is immediately available to care providers. Questionnaires include the STarT Back Screening Tool, Oswestry Disasbility Index (ODI), The Patient Health Questionnaire-9 (PHQ-9) depression screen, and several Patient-Reported Outcome Measurement Information System (PROMIS) v1.0 scales, anxiety, satisfaction with social roles, fatigue, pain intensity, physical function and sleep disturbance. Reduction in ODI of 10 or more points is considered to indicate clinically meaningful improvement. PROMIS is a set of self-report measures that assess an individual physical, mental and social health. A change of 5 or more points in PROMIS scores is considered to reflect a meaningful difference. METHODS This retrospective study reviewed all graduated participants with CLBP enrolled in the BoT. RESULTS Analysis was performed on the outcomes of 168 patients completing the BoT program. At the time of graduation, these patients had significant improvement in pain-related disability as measured by MDQ compared to baseline assessments. Clinically significant changes across multiple functional quality of life metrics were also observed, including fatigue, physical function, pain interference and social role satisfaction. In addition, nearly half of the participants demonstrated clinically significant changes in depression and anxiety. CONCLUSIONS The Back on TREK program demonstrates promising 2-year outcomes and supports the basis for creating a standardized way of providing treatment for patients with chronic back pain based in a biopsychosocial treatment paradigm. The process behind the development of this program further emphasizes the value of multispecialty inputs in program development to ensure thorough assessment, intervention and evaluation protocols. The program has since expanded from a pilot status and holds future goals of reaching more individuals with chronic low back pain. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

173. Defining symptomatic versus radiographic distal junctional kyphosis after cervical deformity-corrective surgery

BACKGROUND CONTEXT Distal junctional kyphosis (DJK) is a relatively new surgical concept often defined in the literature as a change in DJK angle PURPOSE To establish a clinically relevant definition of symptomatic DJK. STUDY DESIGN/SETTING Retrospective review of a prospective CD surgery database. PATIENT SAMPLE One hundred and two patients with cervical deformity. OUTCOME MEASURES Demographics, HRQL metrics. METHODS A prospective database of operative CD patients was analyzed. Inclusion criteria were cervical kyphosis >10˚, cervical scoliosis >10˚, cSVA >4cm or CBVA >25˚. DJK angle (DJKA) was defined >10° change in kyphosis between LIV and LIV-2 in addition to >10° index angle. Pts with DJKA >10° & 1) no reop due to DJK(DJF) & 2) no physician-reported neurological sequelae at any time-point up to 1yr were categorized as “mild DJK.” Those with a DJKA >10° in addition to 1) reop due to DJK(DJF) or 2) >1 new-onset neurological sequelae related to DJK (spinal cord deficit, gait disturbance, hyperreflexia, lower-limb spasticity) were categorized as “Symptomatic DJK.” ANOVA explored differences in PROMs (NDI, mJOA, EQ5D, EQ5DVAS, NRS) at baseline (BL) up to 1yr follow-up. Multivariate logistic regression analyzed predictors of inferior HRQLs associated with DJK groups, specifically scoring beyond one standard deviation (SD) of the mean value of all DJK pts. RESULTS One hundred and two CD patients were analyzed. Sixty-five pts had no DJK, 25 pts had mild DJK and 12 pts had symptomatic DJK. By 1 year, 6/12 pts had DJF, 6/12 pts had >1 DJK-related neurologic sequelae not present before surgery(20% corticospinal tract deficit, 20% spasticity, 20% gait impairment, 20% hyperreflexia) without DJF, and 2 pts had both. Symptomatic DJK pts had higher mean DJKA than mild DJK pts immediately postop (29.8° vs 19.1°, p=0.150). No differences in BL HRQLs were noted between groups, including NDI, mJOA, EQ5D, VAS, and NRS Back (all p>0.05). At 1yr, Symptomatic DJK pts had significantly higher disability (52.3 vs 28.7, p=0.006) and trended lower EQ5D scores (0.75 vs 0.81, p=0.059), higher NRS back pain (5.82 vs 4.06, p=0.119), lower VAS (56.4 vs71.7,p=0.084), and lower mJOA (14.2 vs 15.0,p=0.495) than their mild DJK counterparts. Controlling for age and gender, conditional forward regression analysis revealed symptomatic DJK to a strong predictor of NDI >1 SD of the mean compared to mild DJK pts (OR: 43.4 [2.8 - 668.1], p=0.007); that is, symptoDJK increased the odds of NDI>1SD by at least 2.8x in relation to the mild DJK cohort. CONCLUSIONS DJK associated with reoperation and/or neurologic sequelae was associated with inferior quality of life metrics over long-term follow-up. Our results demonstrate that Symptomatic DJK may not necessarily correlate to a greater measured DJK angle per se (ie, >20°); instead, DJK with concurrent neuro findings or subsequent reop better predicts worsened disability compared to DJK alone. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Abstract 3338: Understanding the effect of racial disparities on patients response to dietary intervention during cancer therapy

Abstract Purpose: African American (AA) women have a lower incidence of breast cancer however, their mortality rate is significantly higher compared to Caucasian (C) women. It is postulated that this is in part, due to the increased prevalence of chronic metabolic syndromes such as obesity and diabetes in the AA population. Also, cytotoxic therapies such as radiation, have decreased efficacy in obese and diabetic patients compared to normal weight counterparts. In this study we investigated whether caloric restriction (CR) during radiation, could affect metabolic differences to affect this disparity. We hypothesize that CR may better benefit AA patients via modulation of inflammatory pathway to improve cancer outcomes. Methods: Thirty five patients (16 AA/16C) with Stage 0 or 1 breast cancer were accrued from 2013-2016 and enrolled on an IRB approved study (NCT01819233). Baseline caloric intake was assessed by food diaries for 7-10 days prior to RT simulation and patients were counseled to decrease their total caloric intake by 25% starting after RT simulation. Patients underwent CR for 10 consecutive weeks: 2 weeks of CR alone, 6 weeks of CR and RT to a dose of 60Gy, and 2 weeks of CR alone after RT. Patients were evaluated before and after the 10 weeks for biometric properties, quality of life metrics and serum markers. Results: Compliance with diet between AA and C and cohorts was comparable and while the total cohort lost an average of 9.21 ± 1.27 lbs, the C cohort had a greater decrease in weight of 11.67 ±2.56 lbs compared to the AA patients who lost an average of 7.33 ±1.62 lbs. To determine if the AA patients had a molecular benefit to diet, oncomiR-21, a regulator of inflammation was evaluated. miR-21 increased by 200 fold in control patients treated with RT without diet. The C patients on CR had a dampened upregulation with a miR-21 that only increased 3.2 ± 0.02 fold, while the AA patients had a significant change with an upregulation of 1.9 ± 0.55, p<0.001. A 200 analyte protein array analysis showed AA patients had a unique protein profile with 15.42 % down-regulated analytes compared to 10.45 %. AA patients showed significant reduction in pro-inflammatory markers including IL-1, IL-6, EGFR, bNGF, FGF-4, TGF-b and BMP 5 and BMP-7 (p<0.05). Conclusions: Though AA patients experienced less weight loss compared to their C counterparts, the molecular benefit experienced was significant in terms of the decreased inflammatory response, skin toxicity and decrease in migration/invasion pathways. Further investigation using diet to narrow the breast cancer outcome disparity experienced by our AA patients is warranted. Note: This abstract was not presented at the meeting. Citation Format: Sylvester Jusu, Kaitlyn Dykes, Kevin Ko, Tiziana DeAngelis, Edith Mitchell, Nicole Simone. Understanding the effect of racial disparities on patients response to dietary intervention during cancer therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 3338.

Two-year Functional Outcomes Of Operative Vs. Non-operative Treatment Of Completely Displaced Midshaft Clavicle Fractures In Adolescents: Results From A Prospective, Multicenter, Level 2 Study

Objectives:To investigate the two-year functional outcomes and complications following operative versus non-operative treatment of completely displaced midshaft clavicle fractures in adolescents.Methods:All patients 10-18 years-old treated for a midshaft clavicle fracture between August, 2013 and August, 2018 at one of 8 geographically diverse, high-volume, tertiary-care pediatric centers were enrolled, with independent treatment decisions determined by individual providers. The sub-population of patients with completely displaced fractures was prospectively followed for over 2 years. Clinical course, complications, validated patient-reported outcome measures (PROs), quality of life metrics, and satisfaction scores were analyzed. To address the ceiling effect of the PRO/satisfaction data following clavicle injuries, a priori thresholds for ‘suboptimal’ scores were established (ASES scores <90, QuickDASH scores >10, EQ-5D <0.80). According to ‘intention to treat’ statistical principles, one post-operative complication (and a subsequent secondary operation) was analyzed within the non-operative cohort, given that the patient represented a ‘crossover’ from the non-operative to the operative treatment group.Results:Of the 909 patients enrolled in the prospective study, 417 patients (45.9%) demonstrated completely displaced fractures and maintained enrollment over the study period, 277 (66%) of whom had reached two year follow up, and 151 of whom provided adequate PRO data, representing a 55% response rate. Of these patients, 55 (36%) underwent operative treatment, while 96 (64%) were treated non-operatively. Those treated surgically showed no difference in gender distribution (76% males,p=0.43), athletic participation (p=0.76), or fracture pattern (p=0.18), but were older (mean age 15.3 vs. 13.5 years, p<0.001) and had greater shortening (p<0.001) than those treated non-operatively. Within the subset with adequate complication data, listed in Figure 1, complications were less common in non-surgical than surgical patients (p=0.0003), but this difference did not reach significance when sensory deficits were excluded (p=0.17). There was no difference in secondary surgeries (p=0.43). While greater percentages of operative than non-operative patients reported suboptimal PRO/satisfaction scores (ASES: 15% vs. 5%, QuickDASH 11% vs 5%, satisfaction 11% vs. 5%), these differences did not reach significance (p=0.07, 0.20, 0.06, respectively).Conclusion:At eight large pediatric centers with many surgeons making independent treatment decisions, non-operative treatment of adolescent clavicle fractures demonstrated lower complication rates and similar satisfaction and functional outcomes.These data establish a comprehensive functional assessment of adolescents treated for clavicle fractures, which represents the epidemiological sub-population most affected by this condition. Unlike several adult studies demonstrating superiority in operative treatment, this adolescent study demonstrates equivalent function and fewer complications associated with non-operative treatment.Complications of Completely Displaced Midshaft Clavicle Fractures with 2-Year Follow-UpComplicationSurgical (N=53)Clinical OutcomeNon-Surgical (N=87)Clinical Outcome p-value n (%)n (%)Hardware pain/irritation5 (9.4%)2 out of 5 (40%;3.8% overall): ROH surgery (mean 21.5 months post-op)$1 (1.1%)‘Crossover’ patient: ORIF 2 months post-injury → ROH surgery 10 months post-op0.03Sensory symptoms13 (24.5%)Numbness distal to incision (resolution reported in 5 out of 13, 38%, mean 6 months post-op)1 (1.1%)Occasional paresthesias (6mo post-op) → spontaneous resolution<0.0001Superficial Infection0 (0.0%)0 (0.0%)n/aDeep Infection0 (0.0%)0 (0.0%)n/aDelayed Union2 (3.8%)Patient 1: bone stimulator (6 months post-op) → healing Patient 2: Revision ORIF → healed2 (2.3%)Both patients: non-operative treatment → healedn/aNon-union0 (0.0%)0 (0.0%)n/aSymptomatic Malunion0 (0.0%)2 (2.3%)Patient 1: PT → improvement Patient 2: operative exostosis for bony prominence → resolutionn/aRefracture1 (1.9%)2 wks following ROH → healed w/ non-operative tx2 (2.3%)Both patients: non-operative treatment → healedn/aOther described below)3 (5.7%)0 (0.0%)n/aAtlanto-axial rotatory subluxation (immediately postoperative)1 (1.9%)Unresponsive to halo traction → C1-2 fusion0 (0.0%)n/aIntra-operative blood loss (1 liter) —* urgent vascular surgery consultation1 (1.9%)Ligation of cephalic vein branch0 (0.0%)n/aDevelopment of acromioclavicular (AC) joint ganglion cyst (4 mo post-op)1 (1.9%)US-guided AC joint aspiration, injection (7 mo post-op)#0 (0.0%)n/aAny secondary operation4 (7.5%)3 (3.4%)0.43Any Complication19 (35.8%)8 (9.2%)0.0003Any Complication (excluding ‘Sensory’)9 (17.0%)7 (8.0%)0.17$ ROH = removal of hardware*PT = physical therapy#US = ultrasound

State of the art: open mesh-based inguinal hernia repair.

Open inguinal hernia repair remains the most universal, ubiquitous, reliable, and cost-effective method of addressing the global burden of groin hernias. Advances in anatomic understanding and technique have refined a few well-established techniques that can address the majority of the burden of disease with low rates of morbidity, recurrence, and chronic pain. Prosthetic reinforcement has become routine because of the clear reduction in recurrence rates in general practice conferred by mesh and the less-appreciated consideration of simplification of the repair whereby operator variability, hernia type, anatomic variation, patient habitus, tissue deficiencies, and surgical technique are homogenized by reproducible standard techniques. While minimally invasive laparoscopic and robotic approaches have increased in popularity, availability, and reliability, open inguinal-repair techniques continue to provide durability, low risk, minimal cost, ease of training and dissemination, and excellent outcomes and remain a fundamental foundation for the practice and art of hernia surgery. Additionally, as chronic pain and quality of life metrics supersede recurrence as the primary clinical outcome of inguinal hernia repair, the ability to offer a "tailored approach" with several options ranging from tissue- and mesh-based open repairs to minimally invasive prosthetic reinforcement has become an important consideration in providing each patient with different options and the best possibility of a favorable outcome. Paramount to this is a solid understanding of the anatomy and standardization of proper technique for each operation to minimize complications and maximize patient outcomes.

A phase II randomized trial for early-stage squamous cell carcinoma of the oropharynx: Radiotherapy versus trans-oral robotic surgery (ORATOR).

6006 Background: The incidence of OPSCC has risen rapidly, due to an epidemic of human papillomavirus (HPV) infection. Radiation therapy (RT) has historically been the standard treatment, but transoral robotic surgery (TORS) has surpassed RT in the US as the most common approach, based on assumptions of reduced toxicity or improved quality of life (QOL). No randomized trials have previously compared these treatments. Methods: The ORATOR trial (NCT01590355) enrolled patients with T1-T2 N0-2(≤4 cm) OPSCC amenable to TORS. We randomly assigned patients, stratified by p16 status, to RT (70 Gy/35 fractions, with chemotherapy if N1-2) vs. TORS (± adjuvant [chemo]RT based on pathology). The primary endpoint was a definitive comparison of swallowing QOL at 1-year using the MD Anderson Dysphagia Inventory (MDADI), powered to detect a 10-point improvement (a clinically-meaningful change [CMC]) in the TORS arm. Secondary endpoints included adverse events (AEs), other QOL outcomes [including EORTC scales, the Voice Handicap Index-10, Neck Dissection Impairment Index, and Patient Neurotoxicity Questionnaire], overall- and progression-free survival (OS, PFS). All analyses were pre-specified and intention-to-treat. Results: Between 2012 and 2017, 68 patients were randomized (n = 34 in each arm), in Canada and Australia. Median age was 59 years; 87% were male. Primary tumor sites were palatine tonsil (74%) or base of tongue (26%). Arms were well-balanced for baseline factors, including p16 status (88% in each arm). Median follow-up was 27 months. MDADI scores at 1-year were statistically superior in the RT arm (mean ± SD: 86.9 ± 11.4 vs. 80.1 ± 13.0 in the TORS arm; p = 0.042), but not meeting the definition of a CMC. For the other QOL metrics, outcomes were similar at 1-year. Feeding tube rates at 1-year were 3% (n = 1) vs. 0% respectively. Rates of treatment-related grade ≥2 AEs were similar (91% vs. 100%, p = 0.24), with more neutropenia, constipation and tinnitus in the RT arm and more trismus in the TORS arm (all p &lt; 0.05). There was one TORS bleeding-related death. OS and PFS were similar. Conclusions: RT had superior swallowing QOL scores at 1 year compared to TORS, but the difference was not a CMC. Toxicities differed between the arms. This study provides the first level 1 evidence to inform patients of the QOL impact of both approaches. Clinical trial information: NCT01590355.

Intrauterine closure of myelomeningocele is associated with superior long-term quality of life than postnatal closure: a single-center study.

The Management of Myelomeningocele Study (MOMS) established several important benefits of myelomeningocele fetal closure, including decreased need for shunting at 30 months. However, the effects of fetal closure on long-term quality of life (QOL) have not been studied. In this study, the authors aimed to analyze the differences in long-term QOL between children treated with intrauterine repair and those treated with postnatal repair. Caregivers of children treated with either intrauterine or postnatal closure at a tertiary acute care hospital between 1997 and 2003 were contacted to participate. The Pediatric Quality of Life Inventory (PedsQL 4.0) and a surgical history questionnaire were administered over the phone. Responses to the QOL survey were reverse scored and linearly transformed to a 0-100 scale, with a higher score indicating better QOL. The Mann-Whitney U-test was used to analyze differences in means. Seventy-four children had MMC repair between 1997 and 2003. Twenty-three (31%) of the patients' families responded to the PedsQL 4.0 questionnaire. Of these 23 children, 11 had intrauterine closure and 12 had postnatal closure. The intrauterine group did not differ in age (median [IQR] 17 years [14-17 years] vs 15 years [14-19 years], p = 0.926), sex (27.3% vs 41.7% male, p = 0.469), or lesion level (p = 0.199) from the postnatal group. Fewer patients in the intrauterine group underwent neurosurgical procedures than those in the postnatal group (55.6% vs 100%, p = 0.018). However, of the children receiving neurosurgical procedures, there was no difference in the number of procedures between the intrauterine and postnatal groups (median [IQR] 4 [2-10.5] vs 2.5 [1.75-6.25], p = 0.458). There was no difference in the percentage of children receiving nonneurosurgical procedures between the two groups (100% vs 100%, p > 0.99). Children who underwent intrauterine closure had significantly higher psychosocial health (median [IQR] 70.0 [56.7-83.3] vs 55.0 [42.1-60.0], p = 0.015) as well as total QOL (median [IQR] 56.5 [55.4-81.5] vs 49.5 [32.9-59.0], p = 0.019) than children with postnatal closure. Physical health was not significantly different between the two groups (median [IQR] 62.5 [37.5-78.1] vs 39.1 [18.8-59.4], p = 0.108). Relative to postnatal closure, children who underwent intrauterine closure of MMC demonstrated better long-term QOL as measured by psychosocial and overall QOL metrics. Given that not all medical and socioeconomic confounders were adjusted for due to the low sample size, validation of these results in a larger population and across multiple centers is needed.

Business ethics in the broiler industry

AbstractThe chicken meat, or broiler, business in the United States is a vertically integrated industry in which integrator corporations control all aspects of the business. Primarily through a series of business acquisitions, an industry duopoly has evolved. The two dominant integrator corporations, Pilgrim's Pride and Tyson Foods, are profitable, and their officers and stockholders benefit from the corporations’ financial success. The multitude of local growers who nurture the chickens to maturity for the integrators, however, benefit minimally from the financial success of the integrators, as the growers face a myriad of financial, environmental, community, and health problems. Many growers have difficulty in extracting themselves from an occupation that requires their initial, personal expenditure, or debt of hundreds of thousands of dollars. Additionally, many who live in regions or states of broiler growing facilities suffer from gases emitted by these facilities and correspondingly lower property values. Several demographic, economic, education, health, and quality of life metrics were analyzed for the 50 U.S. states to provide insights regarding the ethics of the broiler industry and why some states produce significantly more broilers than others.

Clinical and Quality of Life Outcomes After Lung Volume Reduction Surgery

Lung volume reduction surgery (LVRS) is the definitive treatment for patients with severe emphysema. There is still a need for long-term data concerning the outcomes of this procedure. This study presents long-term longitudinal data on LVRS including correlation of quality of life (QOL) with pulmonary function testing metrics and includes additional analysis of patients with heterogeneous and homogeneous emphysema. Retrospective analysis of data collected from patients undergoing LVRS over a 9-year period at a single center was performed (N= 93). Pulmonary function and 6-minute walk tests as well as QOL questionnaires were administered before and 1 year after surgery. Descriptive statistics were reported for clinical outcomes and QOL indices. Wilcoxon signed-rank tests were used to examine changes from baseline to end of 1-year follow-up. Spearman correlation coefficients were used to evaluate relationships between clinical and QOL outcomes. At 1-year post surgery, mean forced vital capacity (46%, P ≤ .0001), forced expiratory volume (43%, P ≤ .0001), diffusing capacity of the lungs for carbon monoxide (16%, P ≤ .0001), and 6-minute walk distance (20%, P ≤ .0001) were increased from baseline, while residual volume decreased (23%, P ≤ .0001). There was a positive correlation between changes in QOL and forced expiratory volume, forced vital capacity, and, 6-minute walk distance. Patients having heterogeneous disease had greater improvements in forced expiratory volume, forced vital capacity, residual volume, and diffusing capacity of the lungs for carbon monoxide, and greater QOL compared with patients with homogeneous disease. LVRS continues to be a valuable treatment option for patients with advanced emphysema with reproducible improvements in clinical and QOL metrics. Careful patient selection and optimization prior to surgery are crucial to successful outcomes.

A Systematic Review of Patient-Reported Outcomes for Cosmetic Indications of Botulinum Toxin Treatment.

Botulinum toxin (BTX) injection is the most popular cosmetic procedure in the United States. Although facial rejuvenation is considered cosmetic, physical appearance has meaningful impact on quality of life (QOL), best measured by patient-reported outcomes (PROs). Patient-reported outcomes are now often required for Food and Drug Administration approval of new pharmaceuticals. This review summarizes the PRO instruments and outcomes in evaluating patient QOL after aesthetic BTX administration. PubMed, MEDLINE, Embase, Cochrane Library, CINAHL Plus, and PsycINFO databases were searched for prospective studies using PRO instruments to directly evaluate the success of cosmetic BTX intervention. Five psychometrically validated, facial rhytid-specific PRO tools are currently used in clinical research. Most studies addressing PROs after cosmetic BTX treatment use 1-item Likert scales evaluating overall satisfaction. BTX treatment generally resulted in improved satisfaction and QOL metrics, such as perception of youthfulness, attractiveness, restedness, affect, mood, and self-confidence. Combination treatments, whether of multiple facial areas or with multiple treatment modalities, may improve PROs even further. Validated, specific PRO instruments can be used to better understand patient expectations in regards to cosmetic treatment, thus helping aesthetic dermatologists maximize patient satisfaction and retention.

Identifying predictive cytokine biomarkers in asthma and chronic obstructive pulmonary disease using the Invitrogen ProQuantum high-sensitivity immunoassay platform

Abstract Asthma and chronic obstructive pulmonary disease (COPD) affect hundreds of millions of people worldwide and are a significant cause of morbidity and mortality. These heterogenous and complex inflammatory diseases have few good biomarkers for disease etiology, diagnosis, and monitoring of treatment efficacy. Characterization has previously been performed at genomic and proteomic levels, as well as airway histology, lung function, and quality of life metrics. Since inflammation typically involves one or more cytokine cascades, or pathways responsible for triggering and maintaining such inflammation, cytokine profiles are critical to advancing our understanding of the disease. However, a powerful immunoassay platform with a simplified workflow that is capable of early cytokine detection and minimum sample consumption is lacking in the asthma/COPD research space. The goal of the following study was to determine whether the Invitrogen ProQuantum high-sensitivity immunoassay platform (www.thermofisher.com/proquantum) could prove useful in uncovering biomarker profiles in asthmatic populations. Additional benefits included running the proteomic assay on ubiquitous qPCR instrumentation and the small 2 μL sample requirement. In this study, 168 human serum samples were analyzed (IL-5, IL-6, IL-8, IL-13, IFN-γ and eotaxin-1) across wheezing and asthmatic phenotypes, as well as healthy age-matched controls among both cohorts. Data presented include group-wise analyses that indicate that the ProQuantum high-sensitivity immunoassay has helped uncover predictive biomarkers in samples from wheezing and asthmatic children, that were not previously distinguishable using more traditional immunoassay testing platforms.

Understanding quality of life and treatment history of patients with Bertolotti syndrome compared with lumbosacral radiculopathy.

Bertolotti syndrome is a rare spinal condition that causes low-back pain due to a lumbosacral transitional vertebra (LSTV), which is a pseudoarticulation between the fifth lumbar transverse process and the sacral ala. Bertolotti syndrome patients are rarely studied, particularly with regard to their quality of life. This study aimed to examine the quality of life and prior treatments in patients with Bertolotti syndrome at first presentation to the authors' center in comparison with those with lumbosacral radiculopathy. This study was a retrospective cohort analysis of patients with Bertolotti syndrome and lumbosacral radiculopathy due to disc herniation seen at the authors' institution's spine center from 2005 through 2018. Diagnoses were confirmed with provider notes and imaging. Variables collected included demographics, diagnostic history, prior treatment, patient-reported quality of life metrics, and whether or not they underwent surgery at the authors' institution. Propensity score matching by age and sex was used to match lumbosacral radiculopathy patients to Bertolotti syndrome patients. Group comparisons were made using t-tests, Fisher's exact test, Mann-Whitney U-tests, Cox proportional hazards models, and linear regression models where variables found to be different at the univariate level were included as covariates. The final cohort included 22 patients with Bertolotti syndrome who had patient-reported outcomes data available and 46 propensity score-matched patients who had confirmed radiculopathy due to disc herniation. The authors found that Bertolotti syndrome patients had significantly more prior epidural steroid injections (ESIs) and a longer time from symptom onset to their first visit. Univariate analysis showed that Bertolotti syndrome patients had significantly worse Patient-Reported Outcomes Measurement Information System (PROMIS) mental health T-scores. Adjustment for prior ESIs and time from symptom onset revealed that Bertolotti syndrome patients also had significantly worse PROMIS physical health T-scores. Time to surgery and other quality of life metrics did not differ between groups. Patients with Bertolotti syndrome undergo significantly longer workup and more ESIs and have worse physical and mental health scores than age- and sex-matched patients with lumbosacral radiculopathy. However, both groups of patients had mild depression and clinically meaningful reduction in their quality of life according to all instruments. This study shows that Bertolotti syndrome patients have a condition that affects them potentially more significantly than those with lumbosacral radiculopathy, and increased attention should be paid to these patients to improve their workup, diagnosis, and treatment.

Abstract No. 600 Clinical and technical success of 1% polidocanol chemical microfoam ablation for axial reflux

Evaluate clinical success in patient-reported quality of life metrics and technical success of closure in axial saphenous vein(s) using 1% polidocanol chemical microfoam for ablation of reflux in patients with C2-C6 disease. Retrospective database review of patients with symptomatic C2-C6 disease who had GSV, AAGSV, and/or SSV ± varicosities treated with Varithena from 2016-2018 by two IR staff at a single institution. Clinical success at 3-6 months, measured via VEINES-QOL/Sym, visual analogue scale, Venous Clinical Severity Score, CEAP classification, and Villalta scale. Technical success at 48 hours and 3-6 months measured with US. Pre-procedure evaluation included physical exam, US via accredited vascular lab, and documentation of patient’s baseline. Patients appropriate for treatment had SFJ and/or SPJ and/or axial vein reflux of >0.5 seconds who failed conservative treatment. Presence of deep system reflux, prior DVT, and/or prior venous intervention was recorded. Patients underwent Varithena ablation of 1 or > vessels in one limb or both, in tandem or at a later session. Volume administered per vessel was recorded. Limb(s) were placed into 2 weeks of compression per manufacturer’s guidelines. Technical success defined as complete or partial closure versus failure with non-closure of treated vessels. Clinical success defined as improvement in VEINES-QOL/Sym, VCSS, VAS, or Villalta. Data suggests positive effect of Varithena on both clinical and technical success outcomes. Average pain score decreased (5.03 to 3.31), Villalta score decreased (8.71 to 3.71), QOL increased (45.41 to 54.49), Sym component increased (45.29 to 53.98), and VCSS decreased (7.93 to 3.68); all showing statistical significance (p <.0001-.0003). Technical success at 48-hours was 89.5% and 92.6% at 3-6 months. Varithena yielded statistically significant improvement in patient-reported quality of life and physician-reported exam scores at 3-6 months and technical success at 48-hours and 3-6 months. GSV and SSV had high technical success with least technical success seen in the AAGSV. Clinical success does not appear to depend on technical success, but a high correlation is suggested.Tabled 1Patient DemographicsTotal patients55Total treated limbs75Age, mean (SD)51.3 (12.3)Range: 27-76GenderF: 37; 67.3%M: 18; 32.7%BMI, (mean) range31 (19.2-55)Deep reflux on 1st US (limbs)23 (30.7%)Prior venous intervention (limbs)13 (17.3%)Initial CEAP (limbs)2: 34 (45.3%)3: 19 (25.3%)4: 10 (13.3%)5: 2 (2.7%)6: 10 (13.3%)Volume of Varithena (ml)Mean (SD): 14.2 (6.9)Range: 5-33 Open table in a new tab

Contraceptive Methods and the Impact of Menstruation on Daily Functioning in Women with Sickle Cell Disease.

Women with sickle cell disease (SCD) are living longer as a result of advances in the care of their underlying disease. With the population growing of women living with SCD, reproductive health issues in this population have become an emphasized area of medical care. We sought to describe current patterns of contraception use, menstruation, and quality-of-life (QOL) measures in women with SCD. Using a cross-sectional study design, we administered paper surveys at two academic medical centers to women aged 10 to 55 years with SCD to capture current contraceptive use, characteristics of menstrual cycles, and QOL metrics. Of the 103 women who participated, 12.7% (13/102) experienced a duration of menses >7 days (defined here as prolonged menstrual bleeding). Approximately half of women (51.5%, 53/103) used some form of contraception, with depot medroxyprogesterone acetate injections and condoms being the most common. During their last menstrual periods, women with both dysmenorrhea and prolonged menstrual bleeding (6.9%, 7/102) were more likely to experience more days of poor QOL, with more nights with sleep disturbance (P = 0.001) and more days with trouble taking care of themselves (P = 0.003), as well as being unable to do things they previously enjoyed (P = 0.001), compared with those with neither phenomenon (28.2%, 29/103). Dysmenorrhea and prolonged menstrual bleeding negatively affect the QOL of women with SCD. Menstrual histories and preventive measures for menstruation-related morbidity should be incorporated into routine evaluations of women with SCD.

Quality of Life in Hypoparathyroidism Improves With rhPTH(1-84) Throughout 8 Years of Therapy.

Calcium and vitamin D treatment does not improve reduced quality of life (QOL) in hypoparathyroidism. Recombinant human (rh) PTH(1-84) therapy improves QOL metrics for up to 5 years. Data on QOL beyond this time point are not available. To evaluate the effects of 8 years of rhPTH(1-84) therapy on QOL and factors associated with long-term benefit. Prospective, open-label trial. Referral center. Twenty patients with hypoparathyoidism. RAND 36-Item Short Form Health Survey (SF-36). rhPTH therapy led to substantial improvement in five of the eight SF-36 domains [vitality, social functioning (SF), mental health (MH), bodily pain (BP) and general health] and three of these domains (SF, MH, BP) were no longer lower than the reference population. The improvement in the mental component summary (MCS) score was sustained through 8 years, while the physical component summary (PCS) score improved through 6 years. A lower baseline QOL score was associated with greater improvement. A threshold value <238 (MCS) and <245 (PCS) predicted long-term improvement in 90% and 100% of the cohort, respectively. In patients whose calcium supplementation was reduced, MCS and PCS scores improved more than those whose supplementation did not decline to the same extent. Improvement in PCS was greater in patients whose calcitriol dosage was reduced and duration of disease was shorter. rhPTH(1-84) improves long-term well-being in hypoparathyroidism. The improvements are most prominent in those with impaired SF-36 at baseline and those whose requirements for conventional therapy decreased substantially.

Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy

Malignant airway obstruction (MAO) occurs in 30%of patients with advanced-stage lung cancer, leading to debilitating dyspnea, cough, and hemoptysis. Other than recanalization of the airways, these patients lack long-lasting palliative therapy. The goal of this study was to determine the safety and feasibility of local injection of paclitaxel into the airway wall with a novel microinjection catheter. In this multicentered prospective trial, 23 patients with non-small cell lung cancer and MAO were enrolled from July 2014 through June 2016 to undergo rigid bronchoscopy with recanalization, followed by injection of 1.5mg of paclitaxel with a novel injection catheter. Primary end points consisted of safety (adverse events, severe adverse events, and unanticipated adverse device effects) as well as feasibility (number of injections, injection success). Secondary end points consisted of airway patency improvement, quality of life metrics, and need for further interventions and/or stenting. Nineteen patients underwent rigid bronchoscopy with successful recanalization and paclitaxel injection. There were no adverse events, severe adverse events, or unanticipated adverse device effects. There was an average of 3.4 injections given for a total dose of 1.5mg of paclitaxel in all patients. There was significantly less stenosis postprocedure vspreprocedure (25%-50%vs75%-90%; P< .001), which was unchanged at 6weeks (25%-50%). None of the participants required further interventions or airway stenting. The injection of paclitaxel after recanalization of MAO in patients with non-small cell lung cancer is safe and feasible, using a novel airway injection device. ClinicalTrials.gov; No.: NCT02066103; URL: www.clinicaltrials.gov.

Limitation in Patient-Reported Function Is Associated with Inferior Survival in Older Adults Undergoing Autologous Hematopoietic Cell Transplantation.

Although the use of geriatric assessment (GA) in the allogeneic hematopoietic cell transplantation (HCT) setting has been reported, few studies have evaluated the impact of patient-reported function on autologous HCT (autoHCT) outcomes. In this study, GA, including the administration of Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) quality of life tool, was performed in 184 patients age ≥50 years (median age, 61 years; range, 50 to 75 years) before autoHCT. Associations among GA findings, quality of life metrics, and post-transplantation outcomes were evaluated using Cox regression. Indications for autoHCT included multiple myeloma (73%), non-Hodgkin lymphoma (20%), and other disorders (7%). The median progression-free survival (PFS) was 28 months, whereas the median overall survival (OS) was not reached. In unadjusted analysis, both PFS and OS were significantly associated with 5 GA components: limitation in instrumental activities of daily living, patient-reported Karnofsky Performance Status (KPS), and the Physical, Functional, and BMT subscale scores of the FACT-BMT. In multivariate analysis, 3 components-limitation in instrumental activities of daily living, patient-reported KPS, and FACT-BMT Physical subscale-remained predictive of both PFS and OS when adjusted for age, provider-reported KPS, disease status, and HCT comorbidity index. In older adults undergoing autoHCT, limitation in any 1 of 3 patient-reported measures of functional status was independently associated with inferior PFS and OS, even after adjusting for known prognostic factors.

An analysis of results in a single-blinded, prospective randomized controlled trial comparing non-fixating versus self-fixating mesh for laparoscopic inguinal hernia repair.

It remains unclear whether use of self-fixating mesh during laparoscopic inguinal hernia repair (LIHR) impacts postoperative quality of life (QoL). We hypothesize patients receiving self-fixating mesh during totally extraperitoneal (TEP) LIHR will report less pain and improved QoL compared to those receiving non-fixating mesh. An IRB-approved, single-blinded randomized controlled trial was conducted. Patients with primary, unilateral inguinal hernias were randomized to receive either non-fixating (control) or self-fixating mesh. Clinical visits were conducted 3weeks and 1year after LIHR. A validated Surgical Outcomes Measurement System (SOMS) instrument was used to assess patients' QoL preoperatively and postoperatively along with Carolinas Comfort Scale (CCS) at 3 weeks and 1year after surgery. Comparisons between self-fixating and non-fixating mesh groups were made using Chi-square, Wilcoxon rank-sum or independent samples t tests. Two hundred and seventy patients were enrolled (137 non-fixating vs 133 self-fixating). Preoperatively, there was no difference in mean age, BMI, or median hernia duration between groups (57.9 vs 56.6years, p = 0.550; 26.1 vs 26.8, p = 0.534; 3.0 vs 3.0months, p = 0.846). Median operative times (34 vs 34min, p = 0.545) and LOS were similar. More patients in the non-fixating group received tacks (43 vs 19, p = 0.001). Patients receiving non-fixating mesh recorded better mean SOMS scores for the first 3days following surgery (Day 1: p = 0.005; Day 2: p = 0.002; Day 3: p = 0.024, Table1) indicating less pain. No differences in pain were seen 3weeks or 1year postoperatively. There were zero recurrences found during clinical follow-up in either of the groups. Patients receiving self-fixating mesh report worse postoperative pain in the first 2-3days than those receiving non-fixating mesh. The groups showed no differences across QoL metrics (SOMS and CCS) at 3weeks or 1year postoperatively. Self-fixating mesh does not appear to positively impact QoL after TEP LIHR.

Tibial Nerve and Sacral Neuromodulation in the Multiple Sclerosis Patient with Voiding Dysfunction

Storage and voiding dysfunction are highly prevalent in patients with multiple sclerosis (MS). Many MS patients fail behavioral modifications and oral medications. Neuromodulation in the form of posterior tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM) is a potential treatment for this group of patients. We review contemporary and impactful literature regarding neuromodulation in the MS patient with lower urinary tract dysfunction. Large-scale randomized trials regarding the use of neuromodulation in the treatment neurogenic lower urinary tract dysfunction are limited. Despite this, several small prospective studies demonstrate durable responses to neuromodulation in the MS patient. Posterior tibial nerve trials reveal improvements in urodynamic parameters, incontinence episodes, post-void residual volumes, and quality of life metrics. Additionally, SNM in the MS patient results in improvements in daytime and nighttime frequency, urgency symptom, and quality of life. Currently, the frequent need for routine spinal MRI scans precludes the use of SNM. Limited research suggests that some MRI use may be safe, but investigation in this area is ongoing. Tibial and sacral neuromodulation appear safe and offer significant improvements in lower urinary tract symptoms and quality of life in MS patients who have failed oral medications and behavioral modifications. Though randomized controlled trials are limited in this area, neuromodulation offers great promise to this often refractory and complex patient population. Future studies are warranted and necessary to better evaluate the efficacy of these treatment options.

Decisional Satisfaction, Regret, and Cosmetic Outcomes in Women Treated with Accelerated Partial Breast Radiation

In light of perceived concerns about cosmetic outcomes from accelerated partial breast irradiation (APBI), this analysis provides long-term patient reported metrics in women treated with APBI at one institution. Records of 164 women treated with APBI using balloon catheter high dose rate brachytherapy (BCHDRB) in 34 Gy in 10 fractions from 2005 to 2013 were reviewed after institutional review board approval. Women with ipsilateral or distant recurrence, poor prognosis, second primary, or known dates of death were excluded; women with contralateral recurrence were included if mastectomy was not performed. The Decisional Regret and Satisfaction Scales, quality of life, and cosmesis were captured using questions adapted from NSABP B39. Instruments were administered via mail, telephone, or email to eligible women. Of 141 women who met inclusion criteria, 74 participated, 9 declined, and 58 have yet to be reached. Median age at diagnosis was 62 years(SD=9), and median time from RT completion to surveys was 95 months(SD=8). Histology was pure DCIS(25%), invasive ductal carcinoma(51%), and mixed(24%). The majority had estrogen/progesterone receptor positive disease. Decisional satisfaction was high, and regret was low; 94% felt satisfied with their decision, and 92% would make the same choice again. Factors that were important in decision making included convenience, physician recommendation, financial considerations, novelty of treatment, desire to avoid mastectomy, and recovery time; 46% reported convenience to be the most important factor. Prior to radiation 74% of women were totally satisfied with their breast size, and 96% continued to be totally/somewhat satisfied after APBI. Women were neutral, somewhat/completely dissatisfied in the appearance of their breast before and after APBI in 18% and 19% respectively. After ABPI, 32% reported moderate/large changes in breast size, while 68% reported slight/no changes. Seroma or needle aspiration of seroma were reported in 14% of women, and 89% of those reported this as little/somewhat/very much bothersome. Other side effects reported, were moderate or large hardening of breast(29%), thickening of breast skin(22%), swelling of breast(11%), skin reddening(7%) or darkening(8%). Despite these cosmetic changes, a majority of women(85%) reported total satisfaction with therapy. Overall breast appearance was reported as good/excellent in 70% of women, while 21% and 8% reported fair and poor overall appearance, respectively. Decisional satisfaction remains high 9 years after APBI, even in women with treatment sequela. This study highlights the importance of patient reported cosmesis and quality of life metrics as an adjunct to provider assessment of treatment outcomes.