ObjectiveLocomotor training (LT) as a therapeutic intervention following spinal cord injury (SCI) is an effective rehabilitation strategy for improving motor outcomes, but its impact on non-locomotor functions is unknown. Given recent results of our labs’ pre-clinical animal SCI LT studies and existing overlap of lumbosacral spinal circuitries controlling pelvic-visceral and locomotor functions, we addressed whether LT can improve bladder, bowel and sexual function in humans at chronic SCI time-points (> two years post-injury).Study designProspective cohort study; pilot trial with small sample size.MethodsEight SCI research participants who were undergoing 80 daily one-hour sessions of LT on a treadmill using body-weight support, or one-hour of LT and stand training on alternate days, as part of another research study conducted at the Kentucky Spinal Cord Injury Research Center, University of Louisville, were enrolled in this pilot trial. Urodynamic assessments were performed and International Data Set questionnaire forms completed for bladder, bowel and sexual functions at pre-and post-training time points. Four usual care (non-trained; regular at-home routine) research participants were also enrolled in this study and had the same assessments collected twice, at least 3 months apart.ResultsFilling cystometry documented significant increases in bladder capacity, voiding efficiency and detrusor contraction time as well as significant decreases in voiding pressure post-training relative to baseline. Questionnaires revealed a decrease in the frequency of nocturia and urinary incontinence for several research participants as well as a significant decrease in time required for defecation and a significant increase in sexual desire post-training. No significant differences were found for usual care research participants.ConclusionsThese results suggest that an appropriate level of sensory information provided to the spinal cord, generated through task-specific stepping and/or loading, can positively benefit the neural circuitries controlling urogenital and bowel functions.Trial registrationClinicalTrials.gov NCT03036527
Deficits in urologic function after spinal cord injury (SCI) manifest both as a failure to store and empty, greatly impacting daily life. While current management strategies are necessary for urological maintenance, they oftentimes are associated with life-long side effects. Our objective was to investigate the efficacy of spinal cord epidural stimulation (scES) as a promising therapy to improve bladder control after SCI. A bladder mapping study was undertaken for sixteen sessions over the course of four months in an individual with chronic, motor complete SCI. Varying combinations of stimulating cathode electrodes were initially tested during filling cystometry resulting in the identification of an effective configuration for reflexive bladder emptying at the caudal end of the electrode array. Subsequent systematic testing of different frequencies at a fixed stimulus intensity and pulse width yielded lowest post-void residual volumes at 30 Hz. These stimulation parameters were then tested in four additional research participants and found to also improve reflexive voiding efficiency. Taken together with SCI studies on step, stand, voluntary motor control and cardiovascular regulation, these findings further corroborate that scES has an all-encompassing potential to increase the central state of excitability, allowing for the control of multiple body functions, including the urological system.
This cross-sectional study examines trends in costs of brand-name medications for treatment of non–small cell lung cancer and within-class price differences between these medications in the US from 2015 to 2020.
Carfilzomib and dexamethasone (Kd) has significant activity in relapsed and refractory multiple myeloma. Kd has not previously been evaluated in newly diagnosed multiple myeloma (NDMM). We report a single-arm phase 2 study of 72 patients with NDMM to evaluate the efficacy and tolerability of Kd induction.Carfilzomib was administered in two dosing cohorts with dosing of 20/45 mg/m 2 in the first 25 patients and 20/56 mg/m 2 in the subsequent 47 patients. Carfilzomib was administered on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle, dexamethasone 20 mg was administered orally on days 1, 2, 8,9,15,16, 22 and 23. Treatment was continued to maximum response, progression of disease, or regimen intolerability. Endpoints included overall response rate (ORR), regimen toxicity and impact of carfilzomib on CD34+ stem cell collection yield. Sixty-five pts achieved at least a partial response (PR) for an ORR of 90%. The maximum response achieved was complete response or better in 5 (7%), very good partial response (VGPR) in 42 (58%), PR in 18 (25%) and stable disease in 7 pts (10%). Toxicities were predominantly low grade with 547 grade 1/2 adverse events and 44 grade ≥3 events. The rate of grade ≥3 cardiovascular adverse events was 11.1% with eight observed events. The activity of Kd described represents the highest rate of overall response and ≥VGPR for any 2-agent combination in NDMM reported to date. Kd demonstrated a safety profile consistent with previously reported carfilzomib studies.
Introduction COVID-19 particularly impacted patients with co-morbid conditions, including cancer. Patients with melanoma have not been specifically studied in large numbers. Here, we sought to identify factors that associated with COVID-19 severity among patients with melanoma, particularly assessing outcomes of patients on active targeted or immune therapy. Methods Using the COVID-19 and Cancer Consortium (CCC19) registry, we identified 307 patients with melanoma diagnosed with COVID-19. We used multivariable models to assess demographic, cancer-related, and treatment-related factors associated with COVID-19 severity on a 6-level ordinal severity scale. We assessed whether treatment was associated with increased cardiac or pulmonary dysfunction among hospitalized patients and assessed mortality among patients with a history of melanoma compared with other cancer survivors. Results Of 307 patients, 52 received immunotherapy (17%), and 32 targeted therapy (10%) in the previous 3 months. Using multivariable analyses, these treatments were not associated with COVID-19 severity (immunotherapy OR 0.51, 95% CI 0.19 – 1.39; targeted therapy OR 1.89, 95% CI 0.64 – 5.55). Among hospitalized patients, no signals of increased cardiac or pulmonary organ dysfunction, as measured by troponin, brain natriuretic peptide, and oxygenation were noted. Patients with a history of melanoma had similar 90-day mortality compared with other cancer survivors (OR 1.21, 95% CI 0.62 – 2.35). Conclusions Melanoma therapies did not appear to be associated with increased severity of COVID-19 or worsening organ dysfunction. Patients with history of melanoma had similar 90-day survival following COVID-19 compared with other cancer survivors.
11016 Background: Stress Management and Resiliency Training (SMART) is a validated resilience training program designed to reduce stress, improve emotional resilience, and decrease burnout. The prevalence of burnout among practicing oncologists is as high as 40%, but unknown among oncology trainees. We implemented a virtual format of the SMART program to the Hematology/Oncology fellowship at Mayo Clinic to assess the feasibility of such a delivery, measure baseline rates of burnout in this group, and to investigate if a virtual method of delivery is as effective as in-person delivery as described in the literature. Methods: The SMART project was a mixed-methods, prospective, single arm clinical trial. Hematology/Oncology Fellows at Mayo Clinic were invited to participate. Four one-hour training sessions were conducted virtually. Fellows were given access to SMART online video modules and a book which supported the content covered during virtual training, a companion resilience mobile app, and a paperback mindfulness journal. Stress, burnout, and emotional resilience were measured at baseline and three months post-intervention using the Perceived Stress Scale (PSS), Maslach Burnout Inventory (MBI), and Connor-Davidson Resilience Scale (CD-RISC2). Changes in mean scores on the PSS, MBI, and CD-RISC2 were assessed using the Wilcoxon signed-rank test. Program feedback and feasibility data were obtained during a virtual focus group. Audio transcripts from the focus group were codified for thematic analysis and verified by intercoder triangulation. A 6-month assessment will be due in March 2022. Results: 26 of 50 fellows invited participated in our study. At baseline, 24% of participants had measurable burnout and 92% had moderate to high stress. At 3-months, the number of participants with moderate to high stress decreased to 71%, while rates of burnout remained unchanged. The PSS demonstrated a decrease in mean stress (-10.9%, p = 0.005), while the MBI demonstrated decreased emotional exhaustion (MBI-EE -6.01%, p = 0.04), an improved sense of personal achievement (MBI-PA 28.1%, p < 0.001), but slightly worse feelings of depersonalization (MBI-DP 16.46%, p = 0.05). The CD-RISC2 suggested no change in global emotional resilience (-0.71%, p = 0.82). Thematic analysis of the focus group data revealed that participants overwhelmingly found the program beneficial (83% of all responses), 20% indicated improved stress, and 15% indicated improved work performance. Conclusions: Oncology fellows in this study had lower rates of burnout compared to practicing oncologists. Virtual implementation of the SMART program is feasible and resulted in improvements in stress and prevented worsened burnout. Outcomes were comparable to previously published studies conducted in-person. Focus group participants found the training beneficial, reported lower stress, and improved work performance.
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