Greater Proportion Of Patients Research Articles

Does Addition of a Longer Acting Local Anesthetic Improve Postoperative Pain After Carpal Tunnel Release? A Randomized Controlled Trial

Carpal tunnel release (CTR) is a simple and effective treatment for carpal tunnel syndrome in patients who have failed nonsurgical management. This surgery is often performed in the ambulatory clinic under local anesthesia, with lidocaine, a short-acting agent. Few studies have investigated the use of longer acting agents, such as bupivacaine, for outpatient CTR. Therefore, the aim of our study was to compare the postoperative pain experience after CTR with the use of either our standard lidocaine solution (control) or a mixture consisting of lidocaine and bupivacaine in equal amounts (intervention). Patients undergoing CTR were randomized into control or intervention groups. Postoperative pain severity and numbness were recorded at several timepoints within the first 72 hours. The timing and quantity of postoperative analgesic use (acetaminophen and/or ibuprofen) was also documented. Both patients and assessor were blinded to allocation. Our study cohort included 139 patients: 67 in the control group and 72 in the intervention group. Postoperative pain scores were significantly lower in the intervention group at 6 hours (2.3 vs 3.2) and 8 hours (2.9 vs 3.9). Additionally, patients in the intervention group reported longer time to first analgesic use than those in the control group (5.2 hours vs 3.7 hours). A greater proportion of patients in the intervention group reported postoperative numbness at nearly all time points, compared to the control group. Our study shows that a mixture of bupivacaine and lidocaine improves early postoperative pain but causes prolonged finger numbness when compared to lidocaine alone. As both medications are effective and feasible for outpatient CTR, surgeon and patient preference should guide local anesthetic choice. Therapeutic Ib.

Comparison of the population covered by the 2024 version of the WHO's hepatitis B prevention and treatment guidelines and the Chinese antiviral treatment guidelines

Objective: This study aims to compare the antiviral treatment similarities and differences in the population covered by the 2024 version of the World Health Organization's (WHO) hepatitis B prevention and treatment guidelines and the current Chinese hepatitis B prevention and treatment guidelines, so as to explore their impact on the indications for antiviral therapy in Chinese patients with chronic hepatitis B (CHB). Methods: The information of patients with chronic hepatitis B virus infection who did not receive antiviral treatment was collected through the registration database of the China Clinical Research Platform for Hepatitis B Elimination. Descriptive statistics were conducted on the demographic, blood, biochemical, and virological levels of patients according to the treatment recommendations of the two versions of the guidelines. The Mann-Whitney U test and χ2 test were used to compare the differences and proportional distribution of the treatment populations covered by the two guidelines. The χ2 test was used to analyze the coverage rate of different antiviral treatment indications. Results: A total of 21,134 CHB patients without antiviral treatment were enrolled. 69.4% of patients met the 2024 versions of the WHO guidelines' recommendations. 85.0% of patients met the current Chinese hepatitis B prevention and treatment guidelines. The WHO guidelines for antiviral therapy indications were met in younger patients with higher levels of ALT, AST, and APRI scores, as well as greater proportion of patients with higher viral loads (P<0.001). The WHO guidelines recommended a cut-off value of APRI>0.5, which raised the proportion of patients on antiviral therapy from 6.6% to 30.9%. 45.7% of patients met the antiviral indications for HBV DNA >2000 IU/ml with abnormal transaminase (ALT>30 U/L for males and ALT>19 U/L for females). The reduced APRI diagnostic cut-off value and ALT treatment threshold had further increased the treatment coverage rate by 91.6% in patients with chronic HBV infection in line with the 2024 versions of WHO guidelines. Conclusion: The reduction of the APRI diagnostic cut-off value and the ALT treatment threshold, based on the current hepatitis B guidelines of China, will further improve the treatment coverage of CHB patients.

Evaluating high-flow oxygen therapy after mechanical thrombectomy under general anesthesia in acute ischemic stroke: A retrospective single-center study

BackgroundThe use of mechanical thrombectomy for acute intracranial vascular occlusion under general anesthesia with endotracheal intubation is well-established as a safe and effective method. However, the process of extubation post-surgery presents challenges for certain patients. This retrospective study assesses the safety and efficacy of combining mechanical ventilation with high-flow oxygen inhalation as an interim strategy, while also examining its impact on long-term clinical outcomes. MethodsThis research enrolled 119 patients with acute intracranial large vessel occlusion who underwent mechanical thrombectomy under general anesthesia with tracheal intubation between January 2020 and November 2023. Participants were categorized into two groups: Group 1 (n=55), which received high-flow oxygen (HFO) post-extubation, and Group 2 (n=64), which was treated with routine oxygen supplementation (RO). The study compared reintubation and tracheotomy rates between these groups to determine safety and effectiveness. Additionally, it analyzed long-term clinical outcomes by comparing NIHSS and mRS scores before treatment and at 90-day follow-up. ResultsThe reintubation rate post-extubation was significantly lower in the HFO group (12.7 %, n=7) compared to the RO group (31.2 %, n=20, p=0.016). The incidence of tracheotomy within 7 days was also reduced in the HFO group compared to the RO group (7.3 %, n=4 vs 20.3 %, n=13, p=0.043). Moreover, a greater proportion of patients in the HFO group achieved mRS scores of 0–2 at 90 days post-stroke than those in the RO group (60 %, n=33 vs 40.6 %, n=26, p=0.035). The median NIHSS score at 90 days was more favorable in the HFO group than in the RO group (6, IQR [1–18] vs 8, IQR [1–20], p=0.005). ConclusionThe study suggests that high-flow oxygen therapy after mechanical thrombectomy under general anesthesia with tracheal intubation may lessen the need for reintubation and tracheotomy, potentially leading to improved long-term prognosis.

Impact of Thyroid Autoimmunity on the Clinical and Biochemical Characteristics of Type 1 Diabetes Mellitus Patients.

Type 1 diabetes mellitus (T1DM) is frequently associated with other autoimmune disorders that are characterized by the presence of organ-specific autoantibodies. Autoimmune thyroid disease (AIT) is the most frequent autoimmune disorder associated with T1DM. Thyroid peroxidase antibodies (TPOAb) serve as a marker for diagnosing AIT. Prior research indicates that thyroid dysfunction can negatively impact linear growth and glycemic control in subjects with T1DM. The present study was done to determine the impact of thyroid autoimmunity on the clinical and biochemical characteristics of patients with newly diagnosed T1DM. In this single-center, hospital-based, observational cross-sectional study, we enrolled 70 patients with newly diagnosed T1DM ≤18 years of age. Type 1 diabetes mellitus was diagnosed based on the acute onset of osmotic symptoms with or without diabetic ketoacidosis (DKA), severe hyperglycemia (blood glucose >13.9 mmol/l (>250 mg/dl)), and insulin requirement from the onset of diabetes. Secondary diabetes, pancreatic diabetes (Type 3c), and maturity-onset diabetes of the young (MODY) were excluded. Participants were screened for AIT disease using TPOAb testing. Based on the presence or absence of TPOAb, the participants were categorized into two groups: Group A comprised individuals with T1DM who tested positive for TPOAb, while Group B consisted of those who tested negative for TPOAb. Out of 70 patients, 41.4% were girls and 58.6% were boys, with a mean age of 9.8±4.4 years. The prevalence of TPOAb among the cohort was 18.6%. A significant majority of patients (71.4%), presented with DKA. Group A showed significantly lower mean height standard deviation scores (SDS) compared to Group B (-0.3±0.6 vs. -0.8±0.5, p = 0.004), but no differences in weight SDS or BMI SDS. Hemoglobin A1C (HbA1c) levels, C-peptide levels, and frequency of DKA did not differ between groups. Group A had higher mean thyroid-stimulating hormone (TSH) levels (4.8±3.7 µU/ml vs. 2.6±1.5 µU/ml, p = 0.001) and a greater proportion of patients with TSH levels above the upper limit of normal compared to Group B (38.4% vs. 7.1%, p = 0.008). Additionally, Group A exhibited a higher frequency of glutamic acid decarboxylase antibody (GADA) positivity compared to Group B (46.1% vs. 17.5%, p = 0.04). Patients positive for TPOAb exhibited significantly lower height SDS compared to TPOAb-negative patients. Additionally, T1DM patients with TPOAb positivity showed an increased frequency of GADA compared to those without TPOAb. However, no significant differences were found in HbA1c levels, C-peptide levels, or hematological parameters between TPOAb-positive and TPOAb-negative patients. These findings emphasize the impact of TPOAb on growth parameters in T1DM and advocate for routine screening of TPOAb in all T1DM patients, starting at the time of diabetes diagnosis.

Exploring height outcomes with adjuvant aromatase inhibition in growth hormone-deficient male survivors of childhood cancer.

Aromatase inhibitors (AI) may improve height in short stature conditions; however, the effect in childhood cancer survivors (CCS) is unknown. We assessed final adult height (FAH) in CCS treated with AI and GH compared with those treated with GH alone. Retrospective cohort study of GH-deficient male CCS treated between 2007 and 2023. FAH was noted as the height at the fusion of growth plates or 18 years of age. Multivariable linear regression was used to examine treatment association with FAH, adjusting for other risk factors. Ninety-two patients were included; 70 were treated with GH and 22 with combination AI/GH. The mean age at GH initiation did not differ between groups. The mean age at AI initiation was 13.7±1.9 years. A greater proportion of patients in the AI/GH group were treated with stem cell transplantation, abdominal radiation, total body irradiation, and cis-retinoic acid (p<.01). Multivariable linear regression demonstrated no significant treatment association with FAH Z-score (β=0.04, 95% CI: -0.9 to 0.9). History of spinal radiation (β=-0.93, 95% CI: -1.7 to -0.2), lower starting height Z-score (β=-0.8, 95% CI: -1.2 to -0.4), and greater difference between bone age and chronological age (β=-0.3, 95% CI: -0.5 to -0.07) were associated with lower FAH Z-score. Adjuvant AI was not associated with increased FAH in male CCS compared with GH monotherapy. Future work is needed to determine the optimal adjunctive treatment to maximize FAH for this population.

Abstract PO4-02-11: Optimizing Taxane-based Chemotherapy in Breast Cancer: Retrospective study comparing 4 cycles of TC to 6 cycles of TC

Abstract Breast cancer remains one of the most prevalent cancers among women worldwide. First-line chemotherapy options include anthracycline (AC-T) and Taxane (TC) based regimens. While anthracycline-based chemotherapy is most commonly used, the use of anthracycline-sparing regimens is also approved. The US Oncology 9735 trial conducted in the mid 2000s showed that four cycles of docetaxel and cyclophosphamide (TC4) were superior to four cycles of Doxorubicin and cyclophosphamide (AC). The follow-up ABC trials compared six cycles of TC(TC6) to AC-T. This trial showed that while AC-T was superior to TC, the difference was modest. AC-T has remained the standard of care, but TC is an acceptable option. One retrospective analysis involving 143 patients showed TC4 was non-inferior to TC6, and suggested that TC4 had fewer adverse events; however, statistical significance was not reached. The question remains whether six cycles of TC is required, or if four cycles is adequate. Methods: Patient information was retrieved from the EMR of a large private oncology group. The EMR was screened for all breast cancer patients who began treatment with TC between 1/1/2011 and 12/31/2021. Patients were required to have continuous follow-up, documented up to at least 6/30/2022. Only patients receiving TC as the first-line setting were included, while patients with metastatic disease were excluded. Adjusted Kaplan Meier curves for overall survival (OS) and disease-free survival (DFS) were generated. A log-rank test was used to determine the statistical difference between the two curves. OS was defined from the date of the last chemotherapy given to death. DFS is defined from the date of the last chemotherapy given to disease recurrence. The Chi-square analysis test of homogeneity was conducted to evaluate the differences in reported symptoms. Statistical analysis was completed with IBM SPSS version 29. Ethical approval was obtained from The Brooklyn Hospital Center Institutional Review Board. Results: A total of 376 charts were reviewed, out of which 224 met the criteria for inclusion. Of these 191 patients received TC4 and 33 received TC6. TC4 patients were noted to be older than TC6 patients. There were a higher percentage of hormone-positive cancers in the TC4 group while the TC6 group had a larger proportion of triple-negative breast cancers. There was a larger proportion of stage III patients that received TC6 than in TC4. TC6 patients were also noted to receive neo-adjuvant chemotherapy at a substantially higher rate. A greater proportion of patients in the TC4 group received breast-conserving surgery, with radiation than the TC6 group. TC6 had a completion rate of 76 % (Table 1). There was a significant difference in DFS noted between TC4 and TC6 (p = 0.016) with TC6 patients having a higher rate of relapse. No difference was noted in the overall survival. No differences were seen in side effects between TC4 and TC6, however, there was a trend toward high rates of neutropenia, anemia, and neuropathy seen in the TC6 group (Table 2). Conclusions: This real-world retrospective study reviewed patients who received TC in a large community oncology practice. The study reaffirms conclusions seen in previous retrospective studies conducted in the academic setting that there is no difference in overall survival when using six cycles of TC compared to four cycles of TC. Slight detriment was seen in the DFS setting when using TC6 however the small sample size along with the larger proportion of patients with stage III disease make it challenging to interpret this finding. There was a trend towards higher toxicities with TC6 that did not reach significance. Until a prospective randomized study comparing four vs six cycles of TC is conducted no definitive conclusions can be drawn, however, this study contributes to the current body of evidence that four cycles of TC is adequate and could potentially improve the quality of life of patients with early breast cancer. Table. Patient characteristics Patient characteristics including age, hormone status, stage, type of surgery, radiation, and treatment setting. Table. Adverse effects Adverse effect information obtained from physician documentation, and CBC reports documented at time of treatment with TC. Citation Format: Amith Ahluwalia, Michelle Koifman, Jaspreet Nannar, Bhavya Vachhani, Kanwal Ashraf, Maxim Shulimovich. Optimizing Taxane-based Chemotherapy in Breast Cancer: Retrospective study comparing 4 cycles of TC to 6 cycles of TC [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-02-11.

ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial

IntroductionThe evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in...

A Standardized Post-gastrostomy Feeding Protocol for Pediatric Patients Reduces Time to Postoperative Goal Feeding Volume.

Gastrostomy creation is a common pediatric surgical procedure, but the time to initiation of feeds and to goal feeding volumes postoperatively varies greatly. Delays in reaching goal feeding volumes promote malnutrition and may prolong hospital length of stay. We hypothesized that implementing an accelerated, standardized post-gastrostomy feeding protocol would allow patients to reach goal feeding volumes sooner, without increasing postoperative complications. We conducted a retrospective cohort study of children who underwent gastrostomy tube placement between 1/1/2022 and 11/30/2023. The feeding protocol was implemented on 11/16/2022, with patients separated into pre- and post-protocol cohorts. Abstracted data included comorbidities, time to initiation of enteral feeds, time to goal feeding volume, and postoperative complications. 322 patients were included: 166 pre-protocol and 156 post-protocol. The post-protocol cohort had a greater proportion of patients with gastrointestinal and/or cardiac comorbidities (P < .001). Through the protocol, postoperative enteral feeds were initiated significantly faster (5.4hrs [IQR 43-7.7] vs 7.0hrs [IQR 5.6-14.3]; P < .001). The post-protocol cohort also achieved goal feeding volumes sooner (12.8hrs [IQR 9.1-25.3] vs 26.3hrs [IQR 21.6-38.9]; P < .001). Postoperative complication rates did not differ between cohorts. Sub-analysis of children with complex cardiac conditions also demonstrated faster time to goal nutrition without an associated increase in postoperative events. These findings demonstrate that our accelerated post-gastrostomy feeding protocol was effective in achieving goal enteral nutrition earlier without increasing postoperative adverse outcomes. This protocol may be used by other centers to safely expedite time to goal enteral feeds in children postoperatively.

Hemolysis events in the phase 3 PEGASUS study of pegcetacoplan in patients with paroxysmal nocturnal hemoglobinuria

AbstractPatients with paroxysmal nocturnal hemoglobinuria (PNH) experience complement-mediated intravascular hemolysis leading to anemia, fatigue, and potentially life-threatening thrombotic complications. Pegcetacoplan, a C3 inhibitor, demonstrated sustained improvements in hematologic and clinical parameters in the phase 3 PEGASUS trial in patients with PNH who remained anemic despite C5 inhibitor therapy. The present post hoc analysis describes 26 hemolysis adverse events (AEs) experienced in 19 patients during pegcetacoplan therapy in PEGASUS and baseline patient characteristics potentially associated with increased hemolysis risk. Lactate dehydrogenase (LDH) ≥2× the upper limit of normal (ULN) was observed in 19 events, including 2 with LDH ≥10× ULN. All patients experienced decreased hemoglobin during hemolysis (mean decrease, 3.0 g/dL). In 16 events (62%), a potential complement-amplifying condition underlying the event could be identified. Hemolysis AEs led to study discontinuation in 5 patients. However, of 26 hemolysis AEs, 17 (65%) were manageable without pegcetacoplan discontinuation. A greater proportion of patients with hemolysis AEs (n = 19) had key characteristics of higher disease activity at baseline compared to patients without hemolysis AEs (n = 61), namely higher-than-label eculizumab dose (53% vs 23%), detectable CH50 (total complement function; 74% vs 54%), and ≥4 transfusions in the previous 12 months (68% vs 51%). These characteristics may be useful predictors of potential future hemolysis events. This trial was registered at www.ClinicalTrials.gov as #NCT03500549.

Predictors of post stroke cognitive impairment: VITATOPS cognition substudy

IntroductionPost stroke cognitive impairment (PSCI) is a common complication of ischemic stroke. PSCI can involve different depending on clinical and stroke related characteristics. The aim of this study is to determine the factors associated with impairments in specific cognitive domains. MethodsThe Vitamins to Prevent Stroke (VITATOPS) trial is a large, multinational randomised controlled trial. In this substudy, consecutive patients admitted for ischaemic stroke or transient ischaemic attack (TIA) at a tertiary hospital in Singapore were included. PSCI was defined as impairment of any of the six cognitive subgroups – visuoconstruction, attention, verbal memory, language, visual memory and visuomotor function – that were assessed annually for up to five years. Univariate and multivariate Cox proportional hazard models were used to determine factors associated with impairments in each of these cognitive domains. ResultsA total of 736 patients were included in this study, of which 173 (23.5 %) developed cognitive impairment. Out of the six cognitive domains, the greatest proportion of patients had an impairment in visuoconstruction (26.4 %) followed by attention (19.8 %), verbal memory (18.3 %), language (17.5 %), visual memory (17.3 %) and visuomotor function (14.8 %). Patients with posterior circulation cerebral infarction (POCI) as the index stroke subtype had higher rates of cognitive impairment. Further subgroup analyses show that Indian race and advanced age were predictive of language impairment, whilst fewer years of education and POCI were predictive of verbal memory impairment. POCI was predictive of visual memory impairment, and advanced age and POCI were predictive of visuomotor function impairment. ConclusionWe identified visuoconstruction and attention domains to be the most affected in our Asian cohort of PSCI. Advanced age, lower levels of education, posterior circulation strokes and concomitant comorbidities such as peripheral artery disease are independent predictors of PSCI.

370 Is There an Optimal Surgical Approach in Degenerative Cervical Myelopathy?: An Individual Participant Data Meta-Analysis

INTRODUCTION: Contradictions exist about impact of anterior vs. posterior surgical approach on outcomes of degenerative cervical myelopathy (DCM). METHODS: Individual patient data of subjects who underwent surgery for DCM was identified from a pooled dataset of the AO Spine CSM-North America, CSM-International, and CSM-Protect clinical studies. Primary outcomes were changes in short form 36 Physical Component Summary score (SF36-PCS) and mJOA score at 12 months. Secondary outcomes were change in total Neck Disability Index (NDI) score and SF36 Mental Component Summary score (SF36-MCS). Two comparison cohorts were created: i) anterior surgery and ii) posterior surgery. One-stage mixed-effects meta-analysis with study and treatment exposure as random effects was performed and reported with mean differences and 95% confidence intervals. A subgroup analysis planned a priori in mild DCM patients (mJOA 15-17) was performed. RESULTS: A total of 979 patients met eligibility criteria. Patients who had anterior decompressive surgery experienced greater improvements at 1yr of follow-up than those who underwent posterior decompressive surgery in SF36-PCS score (adjusted MD 1.57 [95% CI 0.11 to 3.03], p = 0.0348) and NDI score (adjusted MD 3.32 [95% CI 0.58 to 6.05], p = 0.0172). A greater proportion of patients that underwent anterior surgery achieved clinically important recovery of their NDI (OR 1.49 [95% CI 1.15 to 1.93], p = 0.002; aOR 1.46 [95% CI 1.08 to 1.96], p = 0.013) and SF36-PCS scores at 1yr (OR 1.45 [95% CI 1.12 to 1.88], p = 0.004, aOR 1.34 [95% CI 1.00 to 1.80], p = 0.052). In patients with mild DCM (n = 186), patients who underwent anterior decompressive surgery experienced greater improvements in SF36-PCS score, mJOA score, and Neck Disability Index score than posterior surgical patients. CONCLUSIONS: Anterior surgical decompression for DCM is associated with greater improvements in 1yr patient-reported outcomes than posterior surgical decompression.

The association between previous use of anti-obesity medication and semaglutide weight loss outcomes.

To compare weight loss outcomes between patients starting semaglutide who had previously been on another anti-obesity medication (AOM) compared to those who were AOM-naïve. We performed a retrospective study in patients with overweight or obesity taking semaglutide for weight loss for a duration of 3 to 12 months. Our primary endpoint was assessment of percentage of total body weight loss (TBWL) in patients who started semaglutide as their first AOM (AOM-naïve) compared to those who started semaglutide and had previously taken another AOM (non-AOM-naïve). The secondary outcome was a comparison of the proportions of patients achieving ≥5%, ≥10%, ≥15% and ≥20% TBWL between the groups. Our endpoints were analysed using independent t-tests and ANOVA/ANCOVA for continuous variables and Pearson's test for categorical variables. This study included 305 patients. Outcomes of semaglutide treatment were superior in AOM-naïve patients (n = 231) compared to non-AOM-naïve patients (n = 74) at 3 (6.3% vs. 3.8%), 6 (10.6% vs. 6.7%), 9 (14.0% vs. 9.1%) and 12 months (14.3% vs. 10.6%; p < 0.0001 at 3, 6 and 9 months, and p = 0.01 at 12 months). A greater proportion of patients in the AOM-naïve group achieved a TBWL ≥ 15% (48% vs 21%; p = 0.02) and ≥20% (27% vs 4% p < 0.01) at 12 months. The use of semaglutide in patients with previous intake of other AOMs was associated with inferior weight loss outcomes in comparison to patients who were AOM-naïve.

Impact of early integrated rehabilitation on fatigue in 600 patients with breast cancer - a prospective study.

Fatigue after breast cancer treatment is a common burden that is challenging to treat. The aim of this study was to explore if such integrated rehabilitation program reduces the prevalence of chronic fatigue compared to simple, non-integrated rehabilitation. The subjects of our prospective study were 600 female breast cancer patients (29-65 [mean 52 years] of age), who participated in the pilot study on the individualized integrated rehabilitation of breast cancer patients in 2019-2021 and were monitored for one year. The control group included 301 patients and the intervention group numbered 299 patients. The patients completed three questionnaires (EORTC QLQ-C30, -BR23 and NCCN): before cancer treatment, and then six and twelve months after the beginning of cancer treatment. The control group obtained the standard rehabilitation program, while the intervention group was part of the early, individualized multidisciplinary and integrated approach of rehabilitation. The rehabilitation coordinator referred patients for additional interventions (e.g., psychologist, gynecologist, pain management team, physiotherapy, clinical nutrition team, kinesiologist-guided online training, vocational rehabilitation, general practitioner). Data on the patients' demographics, disease extent, cancer treatment and complaints reported in questionnaires were collected and analyzed. There were no differences between the control and the intervention group of patients in terms of age, education, disease extent, surgical procedures, systemic cancer treatment, or radiotherapy, and also no differences in the fatigue before the beginning of treatment. However, patients from the control group had a greater level of constant fatigue than patients from the intervention group half a year (p = 0.018) and a year (p = 0.001) after the beginning of treatment. Furthermore, a greater proportion of patients from the control group experienced significant interference with their usual activities from fatigue than from the intervention group, half a year (p = 0.042) and a year (p = 0.001) after the beginning of treatment. A multivariate logistic regression showed that one year after the beginning of treatment, the only independent factor correlated to fatigue was inclusion into the intervention group (p = 0.044). Inclusion in the intervention group was beneficial-patients from the control group were 1.5 times more likely to be fatigued. Early individualized integrated rehabilitation is associated with a lower prevalence of chronic fatigue or fatigue interfering with usual activities in breast cancer patients in comparison to the control group of patients.

Is percutaneous tibial nerve stimulation (PTNS) effective for fecal incontinence (FI) in adults compared with sham electrical stimulation? A meta-analysis.

Sacral nerve neuromodulation (SNM) has been considered the optimal second-line treatment for fecal incontinence (FI). However, SNM involves high cost and requires highly skilled operators. Percutaneous tibial nerve stimulation (PTNS) has emerged as an alternative treatment modality for FI, yielding varying clinical outcomes. We conducted this meta-analysis to evaluate the effectiveness and safety of PTNS compared to sham electrical stimulation for FI. PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies from May12, 2012 to May12, 2022. Four randomized controlled studies were included in this review, involving a total of 439 adult patients with FI (300 in the PTNS group and 194 in the sham electrical stimulation group). Our meta-analysis revealed that PTNS demonstrated superior efficacy in reducing weekly episodes of FI compared to the control groups (MD - 1.6, 95%CI - 2.94 to - 0.26, p = 0.02, I2 = 30%). Furthermore, a greater proportion of patients in the PTNS group reported more than a 50% reduction in FI episodes per week (RR 0.73, 95%CI 0.57-0.94, p = 0.02, I2 = 6%). However, no significant differences were observed in any domains of the FI Quality of Life (QoL) and St Mark's incontinence scores (MD -2.41, 95%CI -5.1 to 0.27, p = 0.08, I2 = 67%). Importantly, no severe adverse events related to PTNS were reported in any of the participants. Our meta-analysis revealed that PTNS was more effective than sham stimulation in reducing FI episodes and led to a higher proportion of patients reporting more than a 50% reduction in weekly FI episodes.

Interventions for Optimization of Guideline-Directed Medical Therapy

Implementation of guideline-directed medical therapy (GDMT) in real-world practice remains suboptimal. It is unclear which interventions are most effective at addressing current barriers to GDMT in patients with heart failure with reduced ejection fraction (HFrEF). To perform a systematic review to identify which types of system-level initiatives are most effective at improving GDMT use among patients with HFrEF. PubMed, Embase, Cochrane, CINAHL, and Web of Science databases were queried from January 2010 to November 2023 for randomized clinical trials that implemented a quality improvement intervention with GDMT use as a primary or secondary outcome. References from related review articles were also included for screening. Quality of studies and bias assessment were graded based on the Cochrane Risk of Bias tool and Oxford Centre for Evidence-Based Medicine. Twenty-eight randomized clinical trials were included with an aggregate sample size of 19 840 patients. Studies were broadly categorized as interdisciplinary interventions (n = 15), clinician education (n = 5), electronic health record initiatives (n = 6), or patient education (n = 2). Overall, interdisciplinary titration clinics were associated with significant increases in the proportion of patients on target doses of GDMT with a 10% to 60% and 2% to 53% greater proportion of patients on target doses of β-blockers and renin-angiotensin-aldosterone system inhibitors, respectively, in intervention groups compared with usual care. Other interventions, such as audits, clinician and patient education, or electronic health record alerts, were also associated with some improvements in GDMT utilization, though these findings were inconsistent across studies. This review summarizes interventions aimed at optimization of GDMT in clinical practice. Initiatives that used interdisciplinary teams, largely comprised of nurses and pharmacists, most consistently led to improvements in GDMT. Additional large, randomized studies are necessary to better understand other types of interventions, as well as their long-term efficacy and sustainability.

(401) Treatment Utilization and Temporal Trends in Peyronie’s Disease: A Retrospective Analysis of an Insurance Claims Database

Abstract Introduction The current treatment algorithm for Peyronie’s Disease (PD) was updated in 2015 to exclude oral therapies. Non-surgical pharmacological management is now limited to intralesional therapy with Collagenase Clostridium Histolyticum (CCh), Interferon, or Verapamil. Surgical options include tunical plication, plaque incision/excision with or without grafting, and penile prosthesis surgery with or without adjunctive procedures. An understanding of trends in management of PD since the updated guidelines is limited. Objective Our objective is to assess treatment utilization and temporal trends in PD with the change in guidelines. Methods We conducted a retrospective review of men with PD using data in the IBM MarketScan insurance claims database. Patients were identified using ICD 9/10 codes and treatments were identified using J and CPT codes. Only patients aged ≥18 years with at least 1 year before and after a PD diagnosis were included in the analysis. Descriptive statistics were used to describe non-surgical and surgical treatment groups. Linear regressions were also performed to assess the trends of each year based on initial PD treatment. Results Between 2011-2019, we identified a total of 45,114 patients with a diagnosis of PD. Overall, while the majority (91.9%) chose conservative management with no intervention, 1,041 (2.3%) pursued intralesional therapy and 2,594 (5.8%) pursued surgical intervention as an initial treatment option. Among the patients who initially opted for intralesional therapy, 67 (6.4%) sought subsequent surgical treatment whereas 974 (93.6%) did not pursue additional treatment. In comparison, 116 (4.5%) patients who initially underwent surgical intervention sought subsequent treatment with the remaining 2,478 (95.5%) not pursuing additional treatment. Annual overall treatment rates increased from 7.2% to 8.1%. There was a statistically significant increase in the utilization of intralesional therapies from 0.3% in 2011 to 4.1% in 2019 (p=0). Surgical interventions significantly declined from 6.8% to 3.9% over the same time period (p=0.004). Conclusions The present study demonstrates that PD treatment trends have changed over time. With overall low secondary treatment rates for patients initially pursuing either non-surgical or surgical treatment options, a greater proportion of patients are initially pursuing less invasive, non-surgical treatment options with intralesional therapy over time. These findings emphasize the dynamic nature of treatment decisions and contribute to a deeper understanding of the treatment landscape that can be incorporated into patient counseling. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Paterna bio, Firmtech, Turtle health, Maximus, Carrot, Contraline, endo pharmaceuticals, inherent biosciences, techfields inc, macro trials, alto neurosciences, curebase, vivify medical.

Internal hemipelvectomy: A single institution's learning curve and longitudinal experience.

Wide margin resection for pelvic tumors via internal hemipelvectomy is among the most technically challenging procedures in orthopedic oncology. As such, surgeon experience and technique invariably affect patient outcomes. The aim of this clinical study was to assess how an individual surgeon's experiences and advancements in technology and techniques in the treatment of internal hemipelvectomy have impacted patient outcomes at our institution. This study retrospectively examined a single tertiary academic institution's consecutive longitudinal experience with internal hemipelvectomy for primary sarcoma or pelvic metastases over a 26-year period between the years 1994 and 2020. Outcomes were assessed using two separate techniques. The first stratified patients into cohorts based on the date of surgery with three distinct "eras" ("early," "middle," and "modern"), which reflect the implementation of new techniques, including three-dimensional (3D) computer navigation and cutting guide technology into our clinical practice. The second method of cohort selection grouped patients based on each surgeon's case experience with internal hemipelvectomy ("inexperienced," "developing," and "experienced"). Primary endpoints included margin status, complication profiles, and long-term oncologic outcomes. Whole group multivariate analysis was used to evaluate variables predicting blood loss, operative time, tumor-free survival, and mortality. A total of 72 patients who underwent internal hemipelvectomy were identified. Of these patients, 24 had surgery between 1994 and 2007 (early), 28 between 2007 and 2015 (middle), and 20 between 2016 and 2020 (modern). Twenty-eight patients had surgery while the surgeon was still inexperienced, 24 while developing, and 20 when experienced. Evaluation by era demonstrated that a greater proportion of patients were indicated for surgery for oligometastatic disease in the modern era (0% vs. 14.3% vs. 35%, p = 0.022). Fewer modern cases utilized freehand resection (100% vs. 75% vs. 55%, p = 0.012), while instead opting for more frequent utilization of computer navigation (0% vs. 25% vs. 20%, p = 0.012), and customized 3D-printed cutting guides (0% vs. 0% vs. 25%, p = 0.002). Similarly, there was a decline in the rate of massive blood loss observed (72.2% vs. 30.8% vs. 35%, p = 0.016), and interdisciplinary collaboration with a general surgeon for pelvic dissection became more common (4.2% vs. 32.1% vs. 85%, p < 0.001). Local recurrence was less prevalent in patients treated in middle and modern eras (50% vs. 15.4% vs. 25%, p = 0.045). When stratifying by case experience, surgeries performed by experienced surgeons were less frequently complicated by massive blood loss (66.7% vs. 40% vs. 20%, p = 0.007) and more often involved a general surgeon for pelvic dissection (17.9% vs. 37.5% vs. 65%, p = 0.004). Whole group multivariate analysis demonstrated that the use of patient-specific instrumentation (PSI) predicted lower intraoperative blood loss (p = 0.040). However, surgeon experience had no significant effect on operative time (p = 0.125), tumor-free survival (p = 0.501), or overall patient survival (p = 0.735). While our institution continues to utilize neoadjuvant and adjuvant therapies following current guideline-based care, we have noticed changing trends from early to modern periods. With the advent of new technologies, we have seen a decline in freehand resections for hemipelvectomy procedures, and a transition to utilizing more 3D navigation and customized 3D cutting guides. Furthermore, we have employed the use of an interdisciplinary team approach more regularly for these complicated cases. Although our results do not demonstrate a significant change in perioperative outcomes over the years, our institution's willingness to treat more complex cases likely obscures the benefits of surgeon experience and recent technological advances for patient outcomes.

Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1).

A3 adenosine receptor (A3AR) is overexpressed in the skin and peripheral blood mononuclear cells of psoriasis patients. We investigated the efficacy/safety of piclidenoson (CF101), an orally bioavailable A3AR agonist that inhibits IL-17 and IL-23 production in keratinocytes, in moderate-to-severe plaque psoriasis. The randomized, placebo- and active-controlled, double-blind phase 3 COMFORT-1 trial randomized patients (3:3:3:2) to piclidenoson 2 mg BID, piclidenoson 3 mg BID, apremilast 30 mg BID or placebo. At Week 16, patients in the placebo arm were re-randomized (1:1:1) to piclidenoson 2 mg BID, piclidenoson 3 mg BID or apremilast 30 mg BID. The primary end point was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI-75) at Week 16 versus placebo. A total of 529 patients were randomized and received ≥1 dose of study medication (safety population). The efficacy analysis population for the primary end point included 426 patients (piclidenoson 2 mg BID, 127; piclidenoson 3 mg BID, 103; apremilast, 118; placebo, 78). Piclidenoson at 2 and 3 mg BID exhibited similar efficacy. The primary end point was met with the 3 mg BID dose: PASI 75 rate of 9.7% versus 2.6% for piclidenoson versus placebo, p = 0.037. The PASI responses with piclidenoson continued to increase throughout the study period in a linear manner. At week 32, analysis in the per-protocol population showed that a greater proportion of patients in the piclidenoson 3 mg BID arm (51/88, 58.0%) achieved improvement from baseline in Psoriasis Disability Index (PDI) compared to apremilast (59/108, 55.1%), and the test for noninferiority trended towards significance (p = 0.072). The safety/tolerability profile of piclidenoson was excellent and superior to apremilast. Piclidenoson demonstrated efficacy responses that increased over time alongside a favourable safety profile. These findings support its continued clinical development as a psoriasis treatment (ClinicalTrials.gov identifier: NCT03168256).

Virtual Cancer Care Beyond the COVID-19 Pandemic: Patient and Staff Perspectives and Recommendations.

COVID-19 catalyzed rapid implementation of virtual cancer care (VC); however, work is needed to inform long-term adoption. We evaluated patient and staff experiences with VC at a large urban, tertiary cancer center to inform recommendations for postpandemic sustainment. All physicians who had provided VC during the pandemic and all patients who had a valid e-mail address on file and at least one visit to the Princess Margaret Cancer Centre in Toronto, Canada, in the preceding year were invited to complete a survey. Interviews and focus groups with patients and staff across the cancer center were analyzed using qualitative descriptive analysis and triangulated with survey findings. Response rates for patients and physicians were 15% (2,343 of 15,169) and 41% (100 of 246), respectively. A greater proportion of patients than physicians were satisfied with VC (80.1 v 53.4%; P < .01). In addition, fewer patients than physicians felt that virtual visits were worse than those conducted in person (28.0 v 43.4%; P < .01) and that telephone and video visits negatively affected the human interaction that they valued (59.8% v 82.0%; P < .01). Major barriers to VC for patients were respect for care preferences and personal boundaries, accessibility, and equitable access. For staff, major barriers included a lack of role clarity, dedicated resources (space and technology), integration of nursing and allied health, support (administrative, clinical, and technical), and guidance on appropriateness of use. Patient and staff perceptions and barriers to virtual care are different. Moving forward, we need to pay attention to both staff and patient experiences with virtual care since this will have major implications for long-term adoption into clinical practice.

P702 Long term outcomes following de-escalation of dose-intensified ustekinumab in patients with Crohn’s disease

Abstract Background Data on outcomes following de-escalation of dose-intensified ustekinumab (UST) in Crohn’s disease (CD) have not been reported. This retrospective cohort study aimed to evaluate the failure rates 6, 12, and 24 months after de-escalation from dose-intensified UST to standard dose UST and identify predictors of failure. Methods Single centre, retrospective study of consecutive CD patients undergoing de-escalation of dose-intensified UST (90mg 4-weekly) to standard dosing (90mg 8-weekly). De-escalation and post de-escalation decisions were informed by protocolised 6-monthly assessment using Harvey-Bradshaw Index, C-reactive protein (CRP), faecal calprotectin (FCP), drug level and intestinal ultrasound. Failure was defined by re-escalation of UST, corticosteroids, switch out of class, or IBD-related hospitalisation or surgery. Success was defined by continued standard UST dosing. Categorical variables were compared using Fisher-exact and continuous variables using Mann-Whitney U tests between groups. Results 14 patients underwent de-escalation from April 2020 to March 2023. The median age was 41 years, disease duration 15 years, and duration on dose-intensified UST 34 months. 43% received IV reinduction at time of escalation, 86% had previous exposure to advanced therapies, of which 43% were dose-intensified. 36% were on an immunomodulator (IMM) at de-escalation. In the 6 months prior to de-escalation, the median CRP was 3.5mg/L, FCP 96mg/g, and 91% were in sonographic remission. 5/14 (36%) failed de-escalation at 6 months and 9/14 (64%) failed by 12 months. Of those with 24 months follow up, 9/12 (75%) failed de-escalation. Median time to failure was 8 months (IQR 4.5-13). All patients who failed underwent re-escalation and 2 required surgery. UST drug levels reduced from 3.6 to 1.9mg/mL 6 months post de-escalation. Re-escalation successfully recaptured response in 7/9 (78%). A greater proportion of patients with successful de-escalation at 12 months received concomitant IMM compared to those that failed (80% vs. 11%, respectively; p = 0.02). There were no other significant differences in clinical or disease characteristics between those with failure vs. success at 6, 12, or 24 months, although numbers were small (Table 1). Conclusion One-third of patients failed de-escalation of dose-intensified UST at 6 months, two-thirds failed at 12 months and three-quarters by 24 months. Patients considered for a trial of de-escalation need close, objective monitoring as most failure occurs early, and re-escalation is successful in the majority. Concomitant IMM may reduce failure rates and should be considered. Further studies are required to confirm these findings and identify additional predictors of de-escalation failure.