Significant Difference In Mean Change Research Articles

The effectiveness of Chinese instrumental music embedded with binaural beats in relieving anxiety related to academic stress among undergraduates: A randomized controlled trial

The study aimed to determine the effectiveness of binaural beat (BB) Chinese music, with dynamic theta- to delta-frequency progression, in relieving anxiety among Singapore undergraduates. It also examined whether the binaural effects differ between students with high and normal trait anxiety. This was a randomized controlled trial with 151 undergraduates assigned to listen to a single 30 min episode of BB Chinese music, Chinese music, or audiobook. The Perceived Stress Scale (PSS) measured stress, while the state subscale of the State-Trait Anxiety Inventory (STAI-S) and root mean square of successive R–R interval differences (RMSSD) were outcome measures for anxiety. Results indicated that mean STAI-S and PSS reductions were not statistically significant between groups. No significant difference in mean change of RMSSD was detected when the BB Chinese music group was compared with the Chinese music or audiobook groups. However, students with high baseline trait anxiety experienced a greater, marginally significant reduction in STAI-S scores and an increase in RMSSD than those with normal trait anxiety after BB exposure. BB Chinese instrumental music may not have anxiolytic effects on healthy undergraduate populations, as evidence for an anxiolytic effect was observed only among students with high baseline trait anxiety, warranting further research on this population.

Bevacizumab vs Ranibizumab in Macular Edema due to Retinal Vein Occlusion: Short-term Outcomes

Introduction & ObjectivesBevacizumab or Ranibizumab was widely used as therapy for macular edema (ME) in retinal veinocclusion (RVO) and diabetic retinopathy. The purpose of this study was to comparing short-termoutcomes for patients who received intravitreal Bevacizumab (IVB) injection or Ranibizumab (IVR)for ME due to RVO
 MethodsThis was observational, cross sectional study comparing patients received IVB or IVR. Primaryoutcomes data (visual acuity and central macular thickness/CMT) and secondary outcomes data(number injection and intra ocular pressure/IOP) were collected at baseline and 3 months afterinjection
 ResultsThere were 4 eyes in each group. There were no significant difference in mean change of visualacuity (-0.275±0.25 vs -0.15±0.5 logMAR; p=0.676) and CMT (-171.50±129.08 vs -98.25±37.67 um;p=0.345) in IVB vs IVR groups. There were also no significant difference in mean change of IOP(2±2.16 vs 2±4.69 mmHg; p=1) and number of injection (2.25±0.50 vs 1.75±0.9; p=0.401 ) in bothgroups.
 ConclusionIn short-term both IVB and IVB have relative similar outcomes on increasing visual acuity anddecreasing CMT in ME due to RVO

The second molar dilemma in orthodontics: to bond or not to bond?

To compare orthodontic treatment (OT) outcome in adolescents undergoing nonextraction fixed OT with or without bonding of second molars using the score of the American Board of Orthodontics Cast Radiograph Evaluation (C-R-Eval). This study included healthy adolescents with skeletal Class I or mild Class II/Class III malocclusion, normal or deep overbite (OB), and mild-to-moderate dental crowding (<5 mm) who underwent nonextraction fixed OT with ("bonded" group) or without ("not-bonded" group) bonding of second molars. Patient treatment records, pre- and posttreatment digital models, lateral cephalograms, and orthopantomograms were assessed. The evaluated outcomes included leveling of the curve of Spee (COS), OB, control of incisor mandibular plane angle (IMPA), number of emergency visits (related to poking wires and/or bracket failure of the terminal molar tubes), treatment duration, and C-R-Eval. Treatment variables were compared across time points and among groups. The sample included 30 patients (mean age 16.07 ± 1.80 years) in the bonded group and 32 patients (mean age 15.69 ± 1.86 years) in the not-bonded group. The mean overall C-R-Eval score was significantly higher (P < .001) in the not-bonded group (25.25 ± 3.98) than in the bonded group (17.70 ± 2.97). There were no significant differences in mean changes of COS, OB, IMPA, or treatment duration among groups. The mean number of emergency visits was significantly higher in the bonded (3.3 ± 0.6) than the not-bonded group (1.9 ± 0.4) (P < .001). Bonding of second molars enhances the outcome of nonextraction fixed OT as demonstrated by the C-R-Eval without increasing treatment duration, irrespective of more emergency visits.

Comparison of virtual vs face-to-face medical nutrition therapy in patients with hyperlipidemia

Since the COVID-19 pandemic, utilization of telemedicine visits has increased. The outcomes of virtual compared to face-to-face (F2F) visits for treating hyperlipidemia are uncharacterized. This observational study compared pre- to post-visit change in lipid markers between 41 virtual and 151 F2F visits with a registered dietitian nutritionist at the University of Michigan Preventive Cardiology program from 3/31/2019–9/31/2022. Total cholesterol (TC), high-density lipoprotein (HDL), and triglycerides (TG) were collected pre- and post-visit with a median 33 days between collections. Low-density lipoprotein (LDL-C) was calculated using the Sampson equation. We used paired T-tests to evaluate mean change in lipid markers for each visit type between pre and post timepoints, and linear regression to compare virtual to F2F visits. There was a significant decrease in TC, LDL-C, and non-HDL-C for both visit types. There was no significant difference in mean change in lipid markers between virtual and F2F visits. Telehealth is a promising strategy for increasing access to medical nutrition therapy.

Effect of the weight-loss program using daily self-weighing combined with personalized counseling led by village health volunteers in adults with obesity in a rural community, Thailand: a randomized controlled trial

BackgroundIn a remote rural community in central Thailand, obesity prevalence among adults significantly rose from 33.9% in 2012 to 44.8% in 2018. Limited information on weight reduction studies in Thai rural communities was available. The present study aims to evaluate the effect of daily self-weighing combined with personalized counseling in order to reduce body weight (BW) and body mass index (BMI) as well as blood pressure (BP).MethodsA randomized controlled trial was carried out in a rural community in central Thailand.One-hundred and seven adults were randomly allocated (1:2) to intervention and control groups. For 20 weeks, participants in the weight-loss program performed self-weighing twice daily and recorded their weight on the calendar. The program also offers weekly counseling visits by village health volunteers (VHV) who make home visits to participants. The primary outcomes were differences in mean change in BW at 20 weeks from baseline between the intervention and control groups.ResultsA total of 107 participants were initially recruited. Of these, 36 participants were allocated to the intervention group and 57 participants to the control group. Significant differences in mean change in BW and BMI at the twelve-, sixteen-, and twenty-week follow-up from baseline between the two groups were observed. At twenty weeks, the mean change in BW was -1.2 kg (95% CI: -2.2, -0.3) and 0.3 kg (95% CI: -0.3, 0.8) in the intervention and control groups, respectively, with p-value = 0.007. Over 20 weeks of the study period, the estimated mean change in BW among the intervention group was 1.0 kg (95% CI -1.7, -0.2) lower than in the control group, with p-value = 0.015. Furthermore, changes in mean BMI and BP over the 20-week follow-up period in intervention participants were recognized.ConclusionsOur study demonstrates that daily self-weighing combined with personalized counseling led by VHV is feasible and can induce weight loss among adults with obesity in a rural community. In addition, the weight-loss program may be a promising additional tool for reducing BP.Trial registrationTrial identification number was TCTR20201020004; first submitted date: 20/10/2020.

Effects of Synbiotic-Containing Bacillus coagulans (GBI-30) on the Cardiovascular Status of Patients With Polycystic Ovary Syndrome: A Triple-blinded, Randomized, Placebo-controlled Study

PurposeDespite the high risk of cardiovascular diseases in women with polycystic ovary syndrome, fewer studies have addressed the improvement of cardiometabolic status of these patients. This study was conducted with the aim of investigating the effects of synbiotic-containing, spore-forming Bacillus coagulans on cardiometabolic indicators, including lipid profile, C-reactive protein, and atherogenic indexes in patients with polycystic ovary syndrome. MethodsIn the present 12-week, triple-blinded, randomized, placebo-controlled clinical trial, 72 women with polycystic ovaries were randomized to receive either 2 g of synbiotic sachet (n = 36) or placebo (n = 36) plus lifestyle modification. Fasting blood samples were taken before and after the intervention. FindingsStatistical analysis was performed in 60 participants with a mean (SD) age of 28.25 (5.98) years who completed the intervention (synbiotic group [n = 34] and placebo group [n = 26]). A significant mean (SD) decrease in C-reactive protein level was observed in the synbiotic group compared with the placebo group (−0.12 [9.57] v. −0.008 [4.69], P = 0.03). No significant differences in mean changes of lipid profile and atherogenic indexes were seen between the 2 groups. Although the estimated mean changes in atherogenic indexes in the synbiotic group indicates a greater reduction than the placebo group, no significant difference was detected. ImplicationsOur 12-week synbiotic intervention improved the inflammatory status in women with polycystic ovaries without affecting lipid profile or atherogenic indexes.

Glucagon-like peptide-1 receptor agonists as a disease-modifying therapy for knee osteoarthritis mediated by weight loss: findings from the Shanghai Osteoarthritis Cohort

ObjectiveObesity is a risk factor for knee osteoarthritis (KOA) development and progression. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are indicated for type 2 diabetes mellitus (T2DM) and obesity. However, whether KOA...

139 Reducing Physical Therapy Consults for Patients with High Functional Mobility in the Acute Medical Inpatient Setting: A Difference-in-Differences Analysis

OBJECTIVES/GOALS: Physical therapy (PT) is key for treating functional decline that inpatients experience but is a constrained resource in hospital settings. The Activity Measure Post-Acute Care (AM-PAC) score is a mobility measurement tool that has been used to define misallocation of PT. We aim to optimize PT referrals using AM-PAC-based clinical decision support . METHODS/STUDY POPULATION: We conducted a prospective study of patients admitted to University of Chicago Medical Center. AM-PAC scores were assessed by nursing staff every 12 hours. Clinical decision support was designed using validated AM-PAC cutoffs (&gt; 18, a predictor of discharge to home). The tool was embedded in hospital medicine note templates, requiring providers to indicate PT referral status based on current AM-PAC scores. The primary outcome, unskilled consult , was defined as PT referral for patients with AM-PAC &gt; 18. Data were collected for one year prior to implementation and one year after implementation for intervention (hospital medicine) and control (general internal medicine) services. Difference in differences analysis was used to assess the association between the intervention and unskilled consults. RESULTS/ANTICIPATED RESULTS: Between October 2018 and March 2021, 18,241 admissions were eligible for the study. Compared to preintervention, there was a lower rate of referral to PT for patients with high AM-PAC mobility scores in the post-intervention period [18.5% vs 16.6%; X2(1) = 7.02; p &lt; 0.01]. In the postintervention time period, the control group experienced a 2.6% increase in unskilled consults while the intervention group experienced a 2.3% decrease, a difference in differences of 4.9% (95% CI -0.07–-0.03 for difference in differences) controlling for age sex, race, LOS, and change in mobility. Compared to preintervention, there was no statistically significant difference in mean change in mobility score post-intervention for either group. DISCUSSION/SIGNIFICANCE: Our results suggest that clinical decision support can decrease unskilled PT consults. Many functionally independent patients can mobilize with nursing or other mobilization staff. Hospitals should consider mobility score-based decision support to prioritize PT for impaired and at-risk patients.

MP51-13 FOUR-YEAR REZUM OUTCOMES IN RELATIONSHIP TO THE NUMBER OF INJECTIONS: IS THE “LESS IS MORE” TREATMENT APPROACH DURABLE?

You have accessJournal of UrologyCME1 Apr 2023MP51-13 FOUR-YEAR REZUM OUTCOMES IN RELATIONSHIP TO THE NUMBER OF INJECTIONS: IS THE “LESS IS MORE” TREATMENT APPROACH DURABLE? Mustufa Babar, Umair Azhar, Justin Loloi, Rahman Sayed, Kevin Labagnara, Michael Zhu, Kevin Tang, Azizou Salami, Sandeep Singh, Matthew Ines, Nazifa Iqbal, and Michael Ciatto Mustufa BabarMustufa Babar More articles by this author , Umair AzharUmair Azhar More articles by this author , Justin LoloiJustin Loloi More articles by this author , Rahman SayedRahman Sayed More articles by this author , Kevin LabagnaraKevin Labagnara More articles by this author , Michael ZhuMichael Zhu More articles by this author , Kevin TangKevin Tang More articles by this author , Azizou SalamiAzizou Salami More articles by this author , Sandeep SinghSandeep Singh More articles by this author , Matthew InesMatthew Ines More articles by this author , Nazifa IqbalNazifa Iqbal More articles by this author , and Michael CiattoMichael Ciatto More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003299.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Traditional treatment approach for Rezum utilizes injections based on prostate volume. Recent literature with short-term follow-up has shown that improvements in lower urinary tract symptoms (LUTS) can be achieved with less injections. We assessed the long-term durability of Rezum outcomes in relationship to the number of injections utilized during treatment. METHODS: A single office, retrospective study was conducted on men with moderate to severe LUTS who were treated with Rezum. Men were stratified into four cohorts based on the number of injections received per lateral prostatic lobe: 1, 2, 3, or 4 injections. International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), and adverse events (AEs) were collected at baseline, 1-, 3-, 6-, 12- and/or 48-months postoperatively. The impact of the number of injections on urinary outcomes and AEs were assessed using multivariate linear regression and logistic regression models, respectively, after adjusting for confounders at baseline. RESULTS: A total of 179 men were included: 58, 91, 22, and 8 men in the 1, 2, 3, and 4 injections cohorts, respectively. Compared to baseline, at 3-months, all cohorts saw significant mean changes in IPSS (-9.7±7.9, p<0.001) and QoL (-1.9±1.9, p<0.001), and improvements remained durable to 48-months (IPSS -10.8±9.0, p<0.001; QoL -2.7±1.9, p<0.001). The 2 injections cohort saw a significantly greater mean change in Qmax at 6-months (10.2±10.1 ml/s) when compared to the 1 injection cohort (0.6±4.6 ml/s, p=0.02). There were no significant differences in mean changes in IPSS, QoL, and PVR between the cohorts at any follow-up (p>0.05). The most common AE was gross hematuria (69.8%), followed by penile burning (65.8%). By 48-months, reoperation rate was 9.2%, with no significant difference in reoperation rates between the cohorts (p>0.05). Multivariate logistic regression showed that for each additional injection, the odds of gross hematuria, penile burning, penile pain, and dysuria increased by 3.8 (95% CI 1.7, 9.1), 2.6 (95% CI 1.2, 5.9), 2.2 (95% CI 1.1, 4.9), and 3.0 (95% CI 1.3, 7.5), respectively. Multivariate linear regression showed that the number of injections was not significantly associated with changes in IPSS, QoL, and PVR at any follow-up (p>0.05) but significantly associated with change in Qmax at 3-months (β=5.7, p=0.02). CONCLUSIONS: Utilizing less lateral lobe injections during Rezum treatment is a safer treatment approach that can still achieve long-term durable relief in LUTS. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e698 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mustufa Babar More articles by this author Umair Azhar More articles by this author Justin Loloi More articles by this author Rahman Sayed More articles by this author Kevin Labagnara More articles by this author Michael Zhu More articles by this author Kevin Tang More articles by this author Azizou Salami More articles by this author Sandeep Singh More articles by this author Matthew Ines More articles by this author Nazifa Iqbal More articles by this author Michael Ciatto More articles by this author Expand All Advertisement PDF downloadLoading ...

Branched-chain amino acids plus vitamin D supplementation promote increased muscle strength following lumbar surgery for lumbar spinal stenosis: a randomized trial

BACKGROUND CONTEXTAdequate nutrition is essential to address the surgical stress response and mitigate loss of muscle mass, strength, and functionality in older adults with lumbar spinal stenosis (LSS). However, it is unknown whether amino acids and/or vitamin D are beneficial in older adults following lumbar surgery for LSS. PURPOSETo evaluate whether branched-chain amino acids (BCAA) plus vitamin D supplementation could attenuate the loss of muscle mass and strength, accelerate the return of functional mobility, and improve clinical outcomes following lumbar surgery for LSS. STUDY DESIGN/SETTINGA single-center, single-blind randomized controlled trial. PATIENT SAMPLEEighty patients who received lumbar surgery for LSS. OUTCOME MEASURESThe primary outcome was the Zurich claudication questionnaire (ZCQ), and secondary outcomes included knee muscle strength, muscle mass measured by bioelectrical impedance analysis, gait speed and a timed up-and-go test (TUG) at 12 weeks postoperatively. Follow-up assessment was performed for the ZCQ at 52 weeks postoperatively. METHODSPatients ingested the supplementation (BCAA group: BCAA plus vitamin D, Nonamino acid group: nonamino acid) twice daily for 3 weeks from the day after surgery, and received two hours of postoperative inpatient rehabilitation 5 times a week. RESULTSNo significant differences were observed in the mean changes on the ZCQ between the two groups at 12 weeks and 52 weeks. At 2 weeks postoperatively, the nonamino acid group showed significant deterioration compared with the BCAA group for strengths of knee extensor and knee flexor (p < .01). At 12 weeks, the BCAA group showed significant improvements in knee extensor strength and knee flexor strength compared with the nonamino acid group (p <.01). There were no significant differences in mean changes of muscle mass, maximum gait speed, and TUG at 12 weeks between two groups. CONCLUSIONSBCAA plus vitamin D supplementation did not improve LSS-related clinical outcomes after lumbar surgery for LSS, even though muscle strength increased. Future studies should focus on long-term outcomes for muscle mass and physical function, including development of sarcopenia and frailty.

Effectiveness of Ultrasound-Guided Platelet-Rich Plasma Injection in Comparison with Standard Conservative Treatment on Improving Pain and Function Among the Athletes with Partial Tear of Anterior Talofibular Ligament of Ankle: A Randomized Controlled Trial

Background: Ankle sprain is the most common injury in the world of sports and anterior talofibular ligament (ATFL) is most commonly affected. It is often underestimated, mismanaged and often result in delayed treatment, prolonged recovery times and long-term sequela. PRP may have enhancing effect on healing of partial tear of ATFL. Thus, the purpose of this study is to determine the role of PRP on partial tear of ATFL. Methods: A randomized controlled trail was done among athletes with partial tear of ATFL who visited Department of Sports Medicine, RIMS, Imphal during January 2021 – June 2022. Patients with MRI diagnosed partial tear of ATFL (N=48) randomized into PRP injection plus rehabilitation, (n=24) and rehabilitation alone, (n=24) groups. The outcomes were compared using Foot and Ankle Disability Index (FADI) score for function and Visual analogue scale for pain at baseline, 2nd, 6th, 12th and 24th weeks respectively. Results: Baseline characteristics were not statistically significant. There was statistically significant improvement seen in within the group comparison from baseline to 2nd, 6th, 12th and 24th weeks in both FADI and VAS in both the groups. There were statistically significant difference in mean changes of VAS and FADI score between the two groups from baseline to 2nd (p=0.007);(p=0.012), 6th (p=0.018);(p=0.009) and 12th (p=0.004); (p=0.001) follow-ups respectively with PRP group having more improvement however no significant difference at 24th weeks. Conclusion: Ultrasound guided PRP injection along with standard rehabilitation program might be a treatment of choice for partial ATFL tear. Keywords: ATFL tear, PRP, FADI, VAS, USG-guided.

Use of Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Agents for Anemia in Non-Dialysis-Dependent Chronic Kidney Disease: A Systematic Review and Meta-Analysis

Background: Anemia is a common complication associated with chronic kidney disease (CKD), driven by decreased erythropoietin (EPO) production and dysregulated iron metabolism. Anemia is associated with decreased quality of life, as well as increased cardiovascular events, dialysis requirements, and mortality. Treatment classically consists of iron repletion and erythropoietin stimulating agents (ESA). However, use of these agents can be associated with hyporesponsiveness, a need for close monitoring to avoid adverse cardiovascular events, and patient inconvenience due to subcutaneous or intravenous administration. Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are novel oral therapeutic agents that promote accumulation of HIF transcription factors and expression of HIF-responsive genes, leading to increased synthesis of EPO and proteins involved in iron metabolism. Multiple large randomized controlled trials (RCTs) investigating the safety and efficacy of HIF-PHIs in the treatment of anemia of non-dialysis dependent CKD (NDD-CKD) have been completed. However, to the best of our knowledge, there have been no recent comprehensive systematic reviews synthesizing this evidence. Aim: The objective of this systematic review is to assess the safety and efficacy of HIF-PHIs in the treatment of anemia caused by NDD-CKD. Methods: A comprehensive search of MEDLINE, Embase, Cochrane (CENTRAL), and the grey literature was done from inception to April 2022. Studies were screened at abstract and full-text level independently and in duplicate. English-language phase three RCTs investigating the use of HIF-PHIs versus placebo or ESAs in anemia of NDD-CKD were included. Baseline characteristics, intervention details, comparator details, and outcome measurement timing were collected. Our primary efficacy outcome measures were mean change in hemoglobin from baseline and proportion of patients achieving a hemoglobin response. Our primary safety outcome was major adverse cardiac events (MACE) defined as a composite of nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. Meta-analysis was done using DerSimonian and Laird random effects model and reported as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CI). Results: 14 studies with a total of 12,681 patients were included in the analysis. HIF-PHIs were associated with increased hemoglobin response rate compared to placebo (RR 9.02, 95%CI 6.85,11.86, p<0.005; I2=56%, N=5). There was no significant difference in hemoglobin response rate for HIF-PHIs versus ESAs (RR 0.97, 95%CI 0.9,1.04, p=0.36; I2=76%, N=9). HIF-PHIs were associated with an increased change in hemoglobin from baseline compared to placebo (MD=1.57, 95%CI 1.29,1.85, p<0.05; I2=93%, N=4). There was no significant difference in mean change in hemoglobin from baseline between HIF-PHIs and ESAs (MD -0.06, 95%CI -0.19,0.07, p=0.38; I2=0, N=2). There was no statistically significant difference in MACE between HIF-PHI and placebo (RR 1.14, 95%CI 0.93,1.40, p=0.2; I2=11%, N=4) or ESA (RR 1.03, 95%CI 0.89, 1.19, p=0.70; I2=23%, N=9). Conclusion: HIF-PHIs are associated with increased mean change in hemoglobin and hemoglobin response rate compared to placebo. HIF-PHIs are non-inferior to ESAs for these outcomes. When used to current hemoglobin targets, MACE outcomes are similar to those seen with ESAs.

Impact Of Traditional Blood Flow Restriction Versus Band Tissue Flossing On Metabolism And Performance

Blood flow restriction during resistance exercise (BFR + RE) increases metabolic stress and muscle fiber recruitment, elevating fatigue even at low resistance loads. Band tissue flossing (BTF) is a method for BFR in which an elastic band wraps around the limb. PURPOSE: The purpose of this study was to compare the effects of BTF to BFR during RE on changes in glucose, lactate, and total work performed. METHODS: Fifteen apparently healthy subjects (25 ± 1.2 yrs) visited the lab for three sessions separated by at least 72 hours. Each session involved 3 sets of 20 max-effort seated leg extensions and flexions on an isokinetic dynamometer with one of three randomized conditions: control (CON), BFR, or BTF. During BFR and BTF sessions, occlusion was applied immediately before exercise and removed immediately after collecting post- blood. Glucose and lactate measurements were collected pre- and immediately post-exercise. Total work performed was recorded during each extension and analyzed for between-condition differences. RESULTS: Only CON and BTF conditions resulted in significantly lower glucose immediately post-exercise compared to pre- (mean change: CON = -11.0 ± 13.5 and BTF = -10.31 ± 10.9 mg/dL). However, no significant differences in mean change in glucose were found between any conditions. In all conditions, blood lactate post-exercise was significantly greater than pre- (mean change: CON = 3.5 ± 0.6, BFR = 3.4 ± 0.5, BTF = 3.4 ± 0.6 mmol/L), again with no between-condition differences in mean change. Total work performed during set 1 was not significantly different between conditions. During set 2, significantly less work was performed in BFR (p = 0.046; 1024.9 ± 96.9 ft-lbs) and BTF (p = 0.004; 865.1 ± 118.2 ft-lbs) when compared to CON (1182.0 ± 115.6 ft-lbs). During set 3, significantly less work was again performed in the BTF condition (p < 0.001; 663.1 ± 333.7 ft-lbs) when compared to CON (1050.7 ± 325.8 ft-lbs). CONCLUSIONS: Application of an occluding device, whether BFR or BTF, results in significantly less work done than without occlusion. Despite the decrease in work, BFR and BTF + RE result in similar increases in lactate and uptake of glucose than CON. This suggests both BTF and BFR are effective for achieving significant metabolite production during RE via lesser amounts of work.

Evaluating the Implementation of a Digital Diabetes Prevention Program in an Integrated Health Care Delivery System Among Older Adults: Results of a Natural Experiment.

The purpose of this natural experiment study was to assess the effectiveness of a 12-month digital Diabetes Prevention Program (DPP) for adults aged 65-75 years with prediabetes and obesity within a large, integrated health care system. Adjusting for propensity scores and covariates, patients who enrolled and participated in the digital DPP had a mean weight loss of 8.6 lb over 12 months and 5.7 lb by 24 months, compared with a steady, minimal weight loss of 1.3 lb over 12 months and 2.8 lb by 24 months among patients not enrolled. There was a significant difference in mean change in A1C between enrolled and nonenrolled patients over 12 months (-0.10%), but not by 24 months (-0.06%). Digital DPP appears to be an effective weight loss option and potential diabetes prevention intervention for older adults at high risk for type 2 diabetes.

Effect of Micro Acupotomy and Stellate Ganglion Stimulation on Patients with Cervical Vertigo

This article aims to evaluate the treatment effect of micro acupotomy and stellate ganglion stimulation on cervical vertigo. 90 patients with cervical vertigo were randomly divided into two groups, observation group and control group, with 45 cases in each group. The observation group was given micro acupotomy and stellate ganglion stimulation and the control group was given regular acupuncture treatment. The two groups were treated for 2 w. The therapeutic effect and evaluation of symptoms and functions of cervical vertigo score of the two groups of patients after treatment were observed. The mean blood flow levels of vertebrobasilar artery, right vertebral artery and left vertebral artery before and after treatment were observed. The results show that there were significant differences in mean changes of vertigo symptoms and functional scores between the two groups of patients (p<0.01) and the improvement of the observation group was larger than that of the control group (p<0.05); there was significant difference in the speeds of the blood flow of the vertebral-basal artery between the two groups before and after treatment (p<0.05) and the improvement of the observation group was larger than that of the control group (p<0.05). By comparison, the clinical effects of the two groups were statistically different (p<0.05), no side effects occurred in the two groups of patients. Micro acupotomy combined with stellate ganglion stimulation is effective in treating cervical vertigo.

Creme de dexpantenol à base de lanolina, hidrocortisona tópica ou observação na prevenção da síndrome mão-pé induzida por capecitabina: um estudo de fase III

INTRODUCTION: The use of capecitabine is associated with hand-foot syndrome (HFS). Since there is anecdotal evidence that lanolin-based creams and topical steroids are useful for the treatment of HFS, we conducted a three- arm phase III trial to compare observation, lanolin-based cream with dexpanthenol (L-D), and topical hydrocortisone in the prevention of HFS. MATERIAL AND METHODS: Patients with breast or colorectal cancer with indication to use capecitabine as a single agent or in combination were randomized in an open-label fashion to one of the three arms. The initial capecitabine dose was 1,000 or 1,250mg/m2, according to the physicians discretion and clinical practice, and dose adjustments followed the local label. The primary endpoint was the frequency of HFS of any grade in the intent-to-treat population, whereas quality of life (QoL), change from baseline in performance status and adverse events were secondary endpoints. RESULTS: Mean age among the 595 patients randomized was 58 years, and 69% were women. 37% of patients had advanced breast cancer and 63% of patients had colorectal cancer. Capecitabine was used as a single agent in 67% of patients; among the remaining 33% of patients, 82% were treated with oxaliplatin-based combinations. HFS of any grade was seen in 35.6% of patients in the observation group, 24.9% with L-D, and 34.3% with hydrocortisone (p=0.039). The unadjusted odds ratio for the frequency of HFS in the arm treated with L-D was 0.60 (95%CI, 0.39 to 0.92). Only between 2.6% and 9.4% of patients had grade 3 HFS. There were no statistically significant differences in mean change from baseline in any of the QoL scores, the distribution of performance status, or the frequency of adverse events among the three arms. CONCLUSION: L-D could be considered a standard strategy in the attempt to prevent capecitabine-induced HFS.

Extended Follow-up of Local Steroid Injection for Carpal Tunnel Syndrome

Local steroid injection is commonly used in treating patients with idiopathic carpal tunnel syndrome, but evidence regarding long-term efficacy is lacking. To assess the long-term treatment effects of local steroid injection for carpal tunnel syndrome. This exploratory 5-year extended follow-up of a double-blind, placebo-controlled randomized clinical trial was conducted from November 2008 to March 2012 at a university hospital orthopedic department. Participants included patients aged 22 to 69 years with primary idiopathic carpal tunnel syndrome and no prior treatment with local steroid injections. Data were analyzed from May 2018 to August 2018. Patients were randomized to injection of 80 mg methylprednisolone, 40 mg methylprednisolone, or saline. The coprimary outcomes were the symptom severity score and rate of subsequent carpal tunnel release surgery on the study hand at 5 years. Secondary outcomes were time from injection to surgical treatment, SF-36 bodily pain score, and score on the 11-item disabilities of the arm, shoulder, and hand scale. A total of 111 participants (mean [SD] age at follow-up, 52.9 [11.6] years; 81 [73.0%] women and 30 [27.0%] men) were randomized, with 37 in the 80 mg methylprednisolone group, 37 in the 40 mg methylprednisolone group, and 37 in the saline placebo group. Complete 5-year follow-up data were obtained from all 111 participants with no dropouts (100% follow-up). At baseline, mean (SD) symptom severity scores were 2.93 (0.85) in the 80 mg methylprednisolone group, 3.13 (0.70) in the 40 mg methylprednisolone group, and 3.18 (0.75) in the placebo group, and at the 5-year follow up, mean (SD) symptom severity scores were 1.51 (0.66) in the 80 mg methylprednisolone group, 1.59 (0.63) in the 40 mg methylprednisolone group, and 1.67 (0.74) in the placebo group. Compared with placebo, there was no significant difference in mean change in symptom severity score from baseline to 5 years for the 80 mg methylprednisolone group (0.14 [95%CI, -0.17 to 0.45]) or the 40 mg methylprednisolone group (0.12 [95%CI, -0.19 to 0.43]). After injection, subsequent surgical treatment on the study hand was performed in 31 participants (83.8%) in the 80 mg methylprednisolone group, 34 participants (91.9%) in the 40 mg methylprednisolone group, and 36 participants (97.3%) in the placebo group; the number of participants who underwent surgical treatment between the 1-year and 5-year follow-ups was 4 participants (10.8%) in the 80 mg methylprednisolone group, 4 participants (10.8%) in the 40 mg methylprednisolone group, and 2 participants (5.4%) in the placebo group. All surgical procedures were conducted while participants and investigators were blinded to type of injection received. The mean (SD) time from injection to surgery was 180 (121) days in the 80 mg methylprednisolone group, 185 (125) days in the 40 mg methylprednisolone group, and 121 (88) days in the placebo group. Kaplan-Meier survival curves showed statistically significant difference in time to surgical treatment (log-rank test: 80 mg methylprednisolone vs placebo, P = .002 ; 40 mg methylprednisolone vs placebo, P = .02; methylprednisolone 80 mg vs 40 mg, P = .37). These findings suggest that in idiopathic carpal tunnel syndrome, local methylprednisolone injection resulted in statistically significant reduction in surgery rates and delay in need for surgery. ClinicalTrials.gov Identifiers: NCT00806871 and NCT02652390.

1439 A Change in The Use of Post-Operative Drains in Total Knee Arthroplasty (TKA)

Abstract Aim Closed suction drains (CSD) are routinely used to reduce the risk of haematoma formation and wound infections in TKA. Our study aims to determine if the use of drains has any impact on estimated blood loss, transfusion rates and length of stay in hospital. Method Elective TKA cases performed under a single consultant between February 2018-March 2020 were identified. Electronic medical records were reviewed, and data collected on relevant variables. Estimated blood loss was calculated using Ward’s formula. Mann-Whitney U test was applied to assess for statistical significance. Results A total of 86 elective TKA cases were included in the study. In 41 cases patients had a CSD insitu post-operatively (group 1), in the other 45 cases a drain was not used (group 2). Both groups had similar distributions of age, BMI, and sex. We found no statistically significant differences in mean change (+/-SD) in haemoglobin post-operatively between group 1 (21.3 (+/- 9.4)) and group 2 (19 (+/- 10)), (p = 0.34). Mean estimated blood loss was 915mls (+/-365) for group 1 and 871mls (+/-455) for group 2, (p = 0.45). Group 1 had a higher rate of transfusion (4.8% vs 2.2%); however, this was not statistically significant (p = 0.51). After accounting for unrelated medical complications or social barriers to discharge, the length of hospital stay was 4.7 (+/- 2.27) and 4.9 (+/- 3.14) for group 1 and 2 respectively, (p = 0.84). There were no reported cases of wound infection in both groups. Conclusions We found the use of drains in TKA confers no benefits in the outcomes evaluated.

Feminization Laryngoplasty: 17-Year Review on Long-Term Outcomes, Safety, and Technique.

Transfeminine patients can experience significant gender dysphoria in vocal communication. Feminization laryngoplasty (FL) is a gender-affirming surgery developed to elevate speaking vocal range, as well as alter vocal resonance and laryngeal cosmesis. The purpose here was to appraise FL's long-term voice outcomes across a 17-year review period. Level III, retrospective study and description of technique. A single-institution transfeminine voice clinic. Voice data (speaking fundamental frequency [F0], lowest F0, highest F0, F0 range in both Hertz and semitones, and maximum phonation time [MPT]) were collected and assessed. Self-assessment of voice femininity and complications were documented. The 162 patients, all transfeminine women, had a mean age of 40 years with 36-month mean follow-up. There were significant increases in mean speaking F0 (Δ = 50 ± 30 Hz, Δ = 6 ± 3 semitones; P < .001) and mean change in lowest F0 (Δ = 58 ± 31 Hz, Δ = 8 ± 4 semitones; P < .001). There was no significant difference in mean change in highest F0 or MPT. There was significant improvement (Δ = 60% ± 39%; P < .001) in perceptual self-assessment of vocal femininity. There was a 1.2% rate of major postoperative complications requiring inpatient admission or operative intervention. There were no differences in vocal outcomes between those patients who had less than 1-year follow-up and those who had 5-year follow-up. FL in this cohort was a safe and effective technique for increasing mean speaking F0, mean lowest F0, and voice gender perception over a prolonged follow-up period. These findings add to the possible treatments aimed at addressing the morbid dysphoria related to voice and communication for our transfeminine patients.

Growth Disturbances in Pediatric Patients Receiving Long-Term Tyrosine Kinase Inhibitor Therapy

Background:Since their approval in 2003, Tyrosine Kinase Inhibitors (TKIs) targeting bcr-abl1 kinase activity have changed the treatment paradigm for children with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). However, off-target inhibition of kinases, such as src and c-kit, can result in impaired osteoblast function, cause an imbalance in calcium and phosphate metabolism, and result in growth impairment in children. The aim of our study was to examine growth over time in pediatric patients receiving TKIs for CML or Ph+ ALL.Description: This is a single institutional retrospective longitudinal cohort study of patients (≤ 21 years of age) diagnosed with CML or Ph+ ALL between January 2000 and December 2015 who received a TKI and had ≥ 1 year of growth data available as of May 31, 2016. Patient demographics, treatment details including the type and duration of TKI therapy and details of concomitant conventional therapy (chemotherapy and radiation) were abstracted. Growth data was abstracted from the start of TKI at yearly intervals up to a maximum of five years or age 20 and from their last available appointment. Specific variables for growth included height, height percentile, height-SDS (height - standard deviation score or z score) and BMI-SDS (body mass index - standard deviation score). Height-SDS and BMI-SDS were determined using the CDC growth chart by age and gender. Age at diagnosis was used as a surrogate for expected pubertal status: pre-pubertal (3 - 8.9 years), pubertal/peri-pubertal (9 - 15.9 years), post-pubertal (16+ years). Overall change in height-SDS / BMI-SDS from baseline to 1-year and last follow-up were compared by diagnosis, gender, and pubertal age using ANOVA. Statistical analysis was performed using SAS® v9.3 (Cary, NC). For all analyses, a p-value of <0.05 was considered to be statistically significant.Results: Our cohort included 48 patients who received a TKI (n=29 CML, n=19 Ph+ ALL) - 46% were male and 38% were non-Hispanic white. The mean age at diagnosis was 12.1 ± 3.7 years for CML and 9.0 ± 4.6 years for Ph+ ALL patients (p=0.01). As expected, mean duration of TKI treatment was longer in CML (4.3 ± 2.8 years) versus Ph+ ALL (2.7 ± 1.7 years). The average duration of follow-up was similar in both groups (CML 4.6 ± 3.54 years vs Ph+ ALL 4.1 ± 2.9 years, p=0.60). At time of diagnosis, the mean Height-SDS for the entire cohort was 0.13 ± 1.28 with no difference between patients by diagnosis (p=0.92). At one year following treatment with TKI a decrease in mean height-SDS was noted, with a more significant difference in Ph+ ALL patients (-0.54 ± 0.21) compared to CML patients (-0.18 ± 0.39) (p=0.002). This difference remained significant at last follow-up (Ph+ ALL -0.96 ± 0.70, CML -0.52 ± 0.74, p=0.05) (Figure 1). There was no significant difference in mean change in height-SDS at 1 year or last follow-up by gender. Overall, the decrease in height-SDS at 1 year was most significant in the pre-pubertal age group (-0.51 ± 0.27) as compared to pubertal/peri-pubertal and post-pubertal groups (-0.26 ± 0.46 and -0.10 ± 0.24 respectively; p=0.04). BMI-SDS at baseline did not differ by diagnosis but did show a significant decrease at one year in Ph+ ALL versus CML patients (-0.18 ± 0.65 and 0.39 ± 0.54 respectively, p=0.003); this stabilized at the time of last follow up (-0.01 ± 0.75 and 0.38 ± 0.80 respectively, p=0.11).Conclusions: Our data underscores the concern of growth disturbances following prolonged TKI exposure in children, the role of exposure relative to pubertal change in bone growth, and the need for understanding off-target mechanisms in childhood survivors. Stabilization of BMI-SDS at the end of follow up with accompanying drop in mean height-SDS points to a mechanism of growth disturbance beyond nutritional deficiencies. This large pediatric cohort treated with TKIs is the first to include Ph+ ALL patients who were younger at onset of TKI treatment, and more likely to be pre/peripubertal at the start TKI exposure. Future directions will focus on a prospective study of musculoskeletal and other organ toxicities in patients treated with TKIs in childhood. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.