Standard Of Care Research Articles

A Pilot Randomised Controlled Trial Involving Financial Incentives to Facilitate Hepatitis C Treatment Uptake Among People Who Inject Drugs: ETHOS Engage Study

The primary aim of this study was to establish the feasibility of implementing a larger RCT designed to evaluate the effect of financial incentives on HCV treatment initiation among persons receiving opioid agonist therapy and/or who have injected drugs in the prior six months. ETHOS Engage is an observational cohort of participants recruited from drug treatment and needle and syringe programs in Australia. Among 11 drug and alcohol clinics, participants who were HCV RNA-positive were randomized (1:1) to receive standard of care or a AUD $60 gift card at treatment initiation. Regarding feasibility, 100% (57/57) of eligible participants enrolled to take part. Twenty-eight participants were randomised to the financial incentive arm (AUD $60 gift card) plus standard of care and 29 participants to the standard of care arm. In this pilot RCT (n = 57), median age was 42 years (IQR 37–49), 63% were male (n = 36), 35% Indigenous (n = 20) and 36% (n = 21) reported injecting drugs daily in the past month. Twelve weeks post-study enrolment, 11 (39%) participants in the financial incentive arm and 17 (59%) participants in the standard of care arm initiated HCV treatment. Findings indicate high feasibility among people who inject drugs to be randomised to receive financial incentives to initiate HCV treatment.

Abstract 4137009: Treating Elderly Cardiogenic Shock Patients with a Microaxial Flow Pump; Is It DANGERous?

Background: The Danish German Cardiogenic Shock trial (DanGer Shock) recently showed a reduction in all-cause mortality when treating selected patients with ST-segment elevation myocardial infarction (STEMI) and cardiogenic shock with a microaxial flow pump (mAFP). Whether there is an age-related differential survival benefit is unknown. Objective: To assess the influence of age on 180-day all-cause mortality in patients with STEMI and cardiogenic shock randomized in DanGer Shock. Methods: In DanGer Shock (an open-label, international, multicenter trial), 355 adult patients (aged ≥18 years with no upper age limit) with STEMI and cardiogenic shock were included and randomized to a mAFP (Impella CP) plus standard care or standard care alone. Patients were stratified in quartiles according to age, and logistic regression analyses were used to assess mortality according to age quartiles, and to evaluate whether age modified the treatment effect of the mAFP. Results: From lowest to highest quartile, patients’ ages ranged from 31-59, 60-69, 70-76, and 77-92, respectively. There were no differences in blood pressure, lactate level, left ventricular ejection fraction and shock severity across age groups. However, the proportion of females (41%) and the prevalence of hypertension (64%) was higher in patients aged ≥77 years (highest quartile), while more patients aged <60 years (lowest quartile) had been resuscitated before randomization. Mortality increased incrementally from the lowest quartile to the highest (31% vs. 47% vs. 61% vs. 73%, p log-rank <0.001), with an adjusted odds ratio for death at 180 days of 5.50 (95%CI 2.65-11.8, p<0.001) in the highest quartile compared to the lowest. Patients in the three lower quartiles had a lower absolute mortality at 180 days if randomized to the mAFP group, whereas patients in the highest quartile had a higher mortality if randomized to the mAFP group, p=0.028 for interaction, Figure. Conclusion: In patients with STEMI-related cardiogenic shock, the overall mortality increased with advancing age, and treatment benefit of the mAFP appeared to diminish in the eldest patients. (DanGer Shock, NCT01633502)

Prepared, Protected, EmPowered (P3): Primary Results of a Randomized Controlled Trial Using a Social Networking, Gamification, and Coaching App to Promote Pre-exposure Prophylaxis (PrEP) Adherence for Sexual and Gender Minority (SGM) Youth Living in the United States.

The population-level reductions in HIV incidence attributed to pre-exposure prophylaxis (PrEP) have not been fully realized among sexual, gender, and racial/ethnic minority youth. P3 (Prepared, Protected, emPowered) is a comprehensive mobile application (app) intervention developed to support PrEP adherence through gamification, medication tracking, and social engagement. A randomized controlled trial was conducted with 246 young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWMSM) currently on or planning to begin PrEP. Participants were randomized in a 1:1:1 ratio to: standard of care (SOC), P3 app (P3), or P3 app plus in-app adherence coaching (P3+). Adherence was measured at 3- and 6- months post enrollment by emtricitabine-triphosphate (FTC-TP) and tenofovir-diphosphate (TFV-DP) levels in dried blood spots consistent with PrEP use > 4 days/week. The primary outcome was the difference in the proportion adherent comparing P3/P3+ to SOC. P3/P3+ was associated with a higher proportion adherent compared to SOC for both outcome measures. At 3 months, the estimated increase in the proportion adherent was 0.13 (95% CI: 0.00, 0.27, p: 0.05) and 0.12 (95% CI: -0.03, 0.26, p: 0.11) for TFV-DP and FTC-TP, respectively. Estimated adherence was higher, but not statistically different, in P3+ compared to P3, for both TFV-DP and FTC-TP. Receipt of P3 (P3 or P3+) is associated with an increase in PrEP adherence among YMSM and YTWSM at 3 months. Additional analyses to discern the role of app usage and sociodemographic and behavioral factors on intervention effects are warranted.

A Randomized Pilot Trial of Virtual Reality Surgical Planning for Head and Neck Oncologic Resection.

Application of virtual reality (VR) for surgical planning may improve clinical outcomes for head and neck cancer (HNC) resection. There is a lack of randomized trials and meaningful metrics to assess such technological applications. Our objective was to evaluate the feasibility of a VR protocol for oncologic surgical planning and assess the impact on surgical outcomes. A randomized controlled trial utilizing a VR Case Enhancement Protocol (VRCEP) versus standard of care (SOC) surgical planning was conducted. The primary endpoint was feasibility, defined as >80% successful VRCEPs. Metrics included surgeon task-load burden (TLB) using the NASA Task-Load Index and "margin events," defined as "the need for defect-driven margins, positive frozen margins, and/or positive final margins." Margin events were used to calculate a margin event score (MES) per case and margin event rate (MER) per cohort. Thirty-four patients were included in the final analysis (17 VRCEP, 17 SOC) with 94.4% of eligible VRCEP cases completed (17/18). Surgeon TLB was unchanged with VRCEP. Cases undergoing VRCEP were associated with a lower mean MES (0.27 vs. 0.94, p = 0.014) and MER (11.6% vs. 35.6%, p = 0.0041). VRCEP was associated with decreased defect-driven margins (10% vs. 53.3%, p = 0.032). Although not statistically significant, positive frozen and final margin rates were lower in VRCEP. Completion of the VRCEP was feasible with no significantincrease in surgeon TLB appreciated. VRCEP yielded fewer MEs. Further investigation into the benefit of VR in HNC resection is warranted. Margin events may represent useful metrics for assessing novel surgical technologies. 2 Laryngoscope, 2024.

Abstract 4135497: Model-informed dosing recommendations for digoxin in interstage single ventricle heart disease

Digoxin is commonly used in infants with single ventricle heart disease (SVD) and may decrease mortality in the interstage period. While labeled for the treatment of heart failure in infants, dosing recommendations do not account for alterations in drug disposition in SVD. We aimed to characterize digoxin pharmacokinetics (PK) in interstage infants with SVD. Infants <3 months with SVD who received enteral digoxin per standard of care after stage 1 and prior to stage 2 palliation were included in this prospective, multicenter, open-label PK study. Preterm infants and those with creatinine >2mg/dL or on extracorporeal support at enrollment were excluded. PK samples were prospectively collected and digoxin plasma concentrations quantitated by HPLC/MS/MS assay validated per FDA guidance. Population PK analysis was performed in NONMEM. Effects of covariates on PK parameters were evaluated. Dosing simulations were conducted in a virtual cohort of infants with SVD that optimized dosing to achieve trough concentrations of 0.5-2 ng/mL, the label-endorsed reference range for heart failure. Across 10 sites, 50 infants contributed 207 PK samples. Table 1 shows cohort characteristics. A 2-compartment model with transit compartment absorption and linear elimination best described the data. Renal function and weight were significant covariates. Infants with SVD had lower apparent clearance than previously reported in infants without SVD. Current labeled dosing resulted in simulated exposures above the reference range ( Figure 1 ). A new dosing regimen for infants with SVD is proposed. Digoxin PK is altered in infants with SVD. Dosing should account for renal function, age, and weight.

Abstract 4119470: ST-Elevation Myocardial Infarction as a Complication of Granulomatosis with Polyangiitis

Description of Case: A 19-year-old female with history of granulomatosis with polyangiitis (GPA) presented to the emergency department after a syncopal episode at a concert. She reported a prodrome of feeling hot and dizzy prior to the event, followed by epigastric discomfort, nausea, and vomiting after regaining consciousness. She had been diagnosed with GPA one year prior to presentation based on serology and biopsy results. Because her disease was felt to be well-controlled on azathioprine, she had been tapered off of prednisone one month prior to presentation. Initial vitals included blood pressure of 90/60 mmHg, and heart rate of 94 bpm. A 12-lead EKG revealed ST segment elevation in leads I, II and aVF with T wave inversions in the lateral leads ( Figure 1 ). Initial bloodwork was notable for troponin I of 0.11ng/mL (upper limit of normal 0.034 ng/mL). A diagnosis of inferior ST-elevation myocardial infarction was made. She was treated with oral aspirin and prasugrel load as well as intravenous heparin and taken urgently to the catheterization laboratory. Diagnostic coronary angiography was significant for single vessel coronary artery disease (CAD) of the right coronary artery (RCA), with acute complete occlusion of the mid-RCA ( Figure 2A-B ). She was treated successfully with primary percutaneous coronary intervention and implant of two overlapping drug eluting stents in the mid-RCA ( Figure 2C ). Discussion: GPA is a systemic necrotizing vasculitis associated with antineutrophil cytoplasmic antibodies (ANCA) that predominantly affects small to medium sized vessels in the respiratory tract and kidneys. Cardiovascular manifestations in GPA are uncommon, but include pericarditis, myocarditis, and coronary arteritis. GPA can affect the coronary arteries either primarily through inflammatory changes in the arterial wall or via systemic inflammation leading to accelerated atherosclerosis. No standardized criteria exist to establish the diagnosis of coronary arteritis and to differentiate it from accelerated atherosclerosis. Long-term treatment of vasculitis patients with coronary involvement is also poorly supported by evidence. Optimization of cardiovascular risk factors is advocated as per standard of care, and vasculitis control may slow disease progression. This case not only raises awareness of cardiac complications in GPA, but highlights the current lack of evidence surrounding secondary prevention in young patients with vasculitis and cardiac complications.

The effects of remdesivir on long-term symptoms in patients hospitalised for COVID-19: a pre-specified exploratory analysis.

There is an unmet need for treatment of long-term symptoms following COVID-19. Remdesivir is currently the only antiviral approved by the European Medicines Agency for hospitalised patients. Here, we report on the effect of remdesivir in addition to standard of care on long-term symptoms and quality of life in hospitalised patients with COVID-19 as part of the open-label randomised NOR-Solidarity trial (NCT04321616). A total of 185 patients were included in the main trial, of which 118 (60%) were randomised to either remdesivir (n = 42; 36%) or a post-hoc defined control group composed of patients who received standard of care alone or standard of care with hydroxychloroquine (n = 76; 64%). Participants were given quality of life surveys to fill out to gauge their self-reported health over time (the COPD assessment test, the EQ-5D-5L and the RAND SF-36). Here we show that after three months, patients treated with remdesivir do not show significant improvements in stated health compared to those who were not. There are self-reported symptoms of fatigue [mean remdesivir group 2.6 (standard deviation 1.5) v control 2.1 (1.6), 95% confidence interval(CI) -1.17 to 0.15, p = 0.129], shortness of breath [3.0 (1.7) v 2.1 (1.8), 95% CI -1.53 to 0.16, p = 0.110] and coughing [1.8 (1.6) v 1.2 (1.5), 95% CI -1.3 to 0.33, p = 0.237] 3 months after randomisation assessed via the COPD Assessment Test. Our findings indicate that treatment with remdesivir during hospitalisation does not provide any clinically relevant long-term benefit.

Plaque characterization and individualized risk assessment

Risk assessment and accurate plaque characterization are key to individual prognosis in coronary artery disease (CAD). The standard of care is cardiac computed tomography (CT), including calcium scoring and coronary CT angiography (CCTA). Diagnosis is based on the CAD-RADS (Coronary Artery Disease-Reporting and Data System) classification. New developments include CT-based fractional flow reserve (CT-FFR) and plaque quantification ("virtual histology"). Acalcium score of0 indicates an event risk of less than 1% over 10years [7, 17]. CAD-RADS classes1 to5 allow risk assessment compared to patients without coronary plaques [2]. CT-FFR has high accuracy (area under the curve [AUC] 0.90; 95% confidence interval 0.87-0.94) in assessing the hemodynamic significance of stenoses compared with invasive coronary angiography [25]. Plaque quantification has shown that anecrotic core greater than 4% is associated with an almost fivefold increase in 5‑year event risk [29]. The presence of obstructive CAD (stenosis > 50%) is astrong prognostic factor. The evaluation of the hemodynamic relevance of 40-90% stenoses by CT-FFR or other functional tests is already guideline-compliant in the USA, but not yet in Germany. Quantitative approaches to measure plaque volume and composition are gaining importance in research and are expected to become relevant in clinical practice. The CAD-RADS 2.0 classification, which also provides therapy recommendations, should be used to assess the extent of CAD.

Motivations behind end-of-life care: a qualitative study of Iranian nurses' experiences.

Providing high-quality end-of-life care is currently a paramount health priority. Given that the standard of care is intrinsically linked to nurses' motivations, it is becoming too imperative to explore the contributing factors Consequently, this study was undertaken to elucidate the experiences of Iranian nurses regarding their motivation for delivering end-of-life care. This research is a qualitative, descriptive inquiry employing conventional content analysis, carried out at two governmental hospitals in Gorgan, northern Iran, from February to July 2023. 12 nurses were purposefully selected to participate in the study, ensuring maximal diversity. The data were collected through semi structured interviews and analyzed using Graneheim and Lundman's five-step method. The coding process was facilitated by the useof MAXQDA version 10 software. To establish rigor, the four criteria outlined by Guba and Lincoln were applied. the participants included eight women and four men with an average age of 39.6 ± 6.31 years. The data analysis yielded five main categories and fifteen subcategories. The main categories were: "The Foundations of professional care in nursing", "Core Drivers in Optimal End-of-Life Care", "Family Involvement in End-of-Life Care", "Incorporating Spiritualism in Care" and "Dominant motivational Issues Within the Caregiving Atmosphere". This study delineates the experiences that influence the provision of end-of-life care from the perspective of Iranian nurses. Innate traits such as empathy and a passion for nursing, in addition to nurses' moral compass and spiritual beliefs, serve as pivotal motivational stimuli. Leveraging these findings can be instrumental in shaping healthcare practices and policies to enhance the quality of end-of-life care.

Abstract 4124370: DAPT for 1-Month Followed by P2Y12 Inhibitor Monotherapy Versus DAPT for 12-Months After Percutaneous Coronary Intervention: A Systematic Review and Meta Analysis of Randomized Controlled Trials

Background: Dual antiplatelet therapy (DAPT) is well established as standard of care following percutaneous coronary intervention (PCI). Recent trials have shown a potential benefit in the reduction of hemorrhagic events with a shorter course of DAPT. However, the optimal duration of DAPT following PCI remains unclear. Question: Is 1 month of DAPT followed by P2Y12 inhibitor monotherapy superior to the standard 12-month DAPT regimen in terms of cardiovascular outcomes in patients post-PCI? Methods: Medline, PubMed, and Cochrane Central Register of Controlled Trials databases were searched for randomized clinical trials (RCTs) comparing 1-month vs. 12-months of DAPT followed by P2Y12 inhibitor monotherapy post-PCI. The outcomes of interest were cardiovascular death, myocardial infarction, and major bleeding. We used R version 4.1.2 (The R Foundation, 2021) to pool the data using a random-effects model. Heterogeneity was assessed with I2. Results: We included three RCTs reporting data from 22,413 patients, of whom 11,180 (49.8%) were treated with 1-month of DAPT, followed by P2Y12 inhibitor monotherapy. Follow-up ranged from 12 months to 24 months. The incidence of all-cause death (RR 1.20; 95% CI 0.95-1.51; p=0.12) and myocardial infarction (RR 0.86; 95% CI 0.71-1.05; p=0.14) were not significantly different between the groups. However, major bleeding (RR 0.51; 95% CI 0.26-0.99; p=0.048) was significantly reduced with a short course of DAPT followed by P2Y12 inhibitor monotherapy, as compared with standard 12 months of DAPT. Conclusion: Following PCI, a transition from DAPT to P2Y12 inhibitor monotherapy at 1-month is associated with a significant reduction in major bleeding as compared with standard DAPT for 12-months, with no significant change in the incidence of all-cause mortality or myocardial infarction.

Abstract 4118641: Trend, Survival, and Disparity Analysis of Heart Transplantation in a Single Large Transplant Center

Background: In the landscape of organ transplantation, heart transplantation stands as a life-saving procedure for patients with end-stage heart failure. Comprehensive analyses of transplant programs are imperative to optimize outcomes and understand the complexities. Hypothesis: This study hypothesizes that an increasing trend of heart transplant service and short-term mechanical circulatory support (STMCS) is the bridge to transplant; the UNOS (United Network for Organ Sharing) guideline positively impacts STMCS utilization. Even with the standard of care, there might be a disparity in receiving care in terms of gender and race. Goal/ Aims: By examining this center's collective experience, this research provides valuable insights into the evolving landscape of heart transplantation, ultimately contributing to advancements in patient care and transplant policy. Methods: This retrospective cohort study includes heart transplant patients in a single large transplant center. For statistical analysis, Cox regression, Mann-Whitney test, Kruskal Wallis, and Chi-Square test were used in IBM SPSS 25. Result: Trends: This retrospective study covering 2010 to 2022 comprehensively analyzed 1513 heart transplant patients. The cohort consisted of 1071 (70.78%) males and 442 (29.21%) females, 31.9% were bridged through STMCS. 76.7% of Caucasian and 16.1% were African American.The mean utilization of STMCS was 20.08% before the UNOS policy change, increasing to 53.81% after that (p < 0.001). Disparity Analysis: There was a statistically significant difference in STMCS utilization between white and black patients (p= 0.008) but no difference in between obese and non-obese cohorts (P=0.362).Wait time was similar among the genders (p=0.161) and different races (p=0.302). Survival Analysis: There is a significant survival discrepancy between patients bridged through MCS and those without STMCS(p< 0.001). However, yearly trend analysis showed an evolving survival trajectory favoring STMCS users. There are statistically significant survival differences among whites and blacks (P =0.008) but similar among the genders (p=0.589). Summary: The study reveals significant changes in the trend of transplants regarding STMCS utilization since the UNOS guideline. There are substantial differences in survival between STMCS vs. non-STMCS groups and among the races.There was a significant difference in STMCS utilization among the races.

Abstract Sa1105: The Effect of a Combination of Neuroprotective Medications on Post-Cardiac Arrest Survival

Introduction: Reperfusion injury after cardiac arrest (CA) leads to poor survival and neurological outcomes. We hypothesized that a combination of pharmacologic neuroprotection therapies administered 24-72 hours post-CA [“combination therapy”] that target key steps in reperfusion injury; 1) excitotoxicity (Magnesium, Memantine, Perampanel, Minocycline), 2) mitochondrial dysfunction (Thiamine, Coenzyme Q10), 3) oxidative stress (Vitamin C, Vitamin E), and 4) inflammation (Hydrocortisone), would improve survival. AIMS: We compared survival between subjects with combination therapy and those without. Methods: A retrospective analysis of post-CA patients (01/01/2019 - 06/01/2023) was conducted as part of a quality improvement project. Inclusion: in-hospital CA, age ≥ 18 years, non-COVID, ≥ 5 min CPR, sustained ROSC (≥ 20 min). Exclusion: out-of-hospital CA. Combination therapy was at the discretion of the provider and given in addition to current post-CA standard critical care: targeted temperature management (TTM) (32-36°C), glucose (target 140 mg/dL), PaO2 (target 100 mmHg), PaCO2 (target 40 mmHg), and MAP (target 80 - 100 mmHg). Survival was assessed at hospital discharge. Results: Among 196 subjects, 146 received combination therapy (study group) and 50 did not (control group). Demographic variables (age, race, ethnicity) and intra-cardiac arrest variables (initial rhythm, CPR duration, and hospital site) were not statistically different between groups. Post-CA variables (mean PaCO2, PaO2, and glucose) were not statistically different between groups. MAP was 76 (69, 83) for study group and 65 (46, 72) for control group ( P = <0.001). Lowest temperature in study group was 34.8°C vs. 35.9°C in control group ( P = 0.034). Survival at hospital discharge was 33% for study group and 14% for control group ( P = 0.01). There were no known safety concerns or adverse events. Conclusions: The administration of a combination of neuroprotective medications that target key pathways in reperfusion injury appears to be feasible and safe, and may improve survival beyond current post-CA standard critical care. A future randomized controlled trial that includes the assessment of neurological outcomes is warranted.

IEPA, a novel radiation countermeasure, alleviates acute radiation syndrome in rodents

Repurposing therapeutic agents with existing clinical data is a common strategy for developing radiation countermeasures. IEPA (imidazolyl ethanamide pentandioic acid) is an orally bioavailable small molecule pseudopeptide with myeloprotective properties, a good clinical safety profile, and stable chemical characteristics facilitating stockpiling. Here, we evaluated IEPA’s radiomitigative efficacy in the hematopoietic subsyndrome of acute radiation syndrome (H-ARS) using total-body irradiation (TBI) models in C57BL/6J mice and WAG/RijCmcr rats, applying various posology schemes and introducing syringe feeding of the IEPA formulation in the pudding. Additionally, we assessed IEPA in the delayed effects of acute radiation exposure (DEARE) model after partial-body irradiation (PBI) in WAG/RijCmcr rats. Endpoints included survival, body weight, hematology, and pulmonary parameters, depending on the model. Results from mouse and rat TBI models demonstrated survival improvements with repeated IEPA dosing at 10 mg/kg, with the largest benefits observed in the bi-daily (BID) treatment over the 30-day ARS phase in female rats. Survival across PBI-DEARE subsyndromes was comparable between IEPA and vehicle groups, though IEPA improved pulmonary parameters in female rats during the lung-DEARE phase. Sex-related differences in response to irradiation and IEPA were noted, with females showing a survival advantage. IEPA treatment is compatible with Neulasta® (Pegfilgrastim; PEG-G-CSF); adequately powered studies are needed to confirm the trend toward improved survival over standard care alone. IEPA is a promising development candidate as a medical countermeasure against the effects of acute radiation syndrome. Further confirmatory studies in small and large animal models should validate the robustness and translatability of preliminary rodent data on IEPA’s radiomitigative efficacy.

PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial.

With over 65,000 new cases per year in Germany, prostate cancer (PC) is the most common cancer in men in Germany. Localized PC is often treated by radical prostatectomy and has a very good prognosis. Postoperative quality of life (QoL) is significantly influenced by the side effects of surgery. One possible approach to improve QoL is postoperative symptom monitoring using ePROMs (electronic patient-reported outcome measures) to accurately identify any need for support. The PRO-P ("Influence of ePROMS in surgical therapy of PC on the postoperative course") study is a randomized controlled trial employing 1:1 randomization at 6weeks postoperatively, involving 260 patients with incontinence (≥ 1 pad/day) at six participating centers. Recruitment is planned for 1year with subsequent 1-year follow-up. PRO-monitoring using domains of EPIC-26, psychological burden, and QoL are assessed 6, 12, 18, 24, 36, and 52weeks postoperatively. Exceeding predefined PRO-score cutoffs triggers an alert at the center, prompting patient contact, medical consultation, and potential interventions. The primary endpoint is urinary continence. Secondary endpoints refer to EPIC-26 domains, psychological distress, and QoL. Aspects of feasibility, effect, and implementation of the intervention will be investigated within the framework of a qualitative process evaluation. PRO-P investigates the effect on postoperative symptom monitoring of a structured follow-up using ePROMs in the first year after prostatectomy. It is one of the first studies in cancer surgery investigating PRO-monitoring and its putative applicability to routine care. Patient experiences with intensified monitoring of postoperative symptoms and reflective counseling will be examined in order to improve primarily urinary continence, and secondly other burdens of physical and psychological symptoms, quality-of-life, and patient competence. The potential applicability of the intervention in clinical practice is facilitated by IT adaption to the certification standards of the German Cancer Society and the integration of the ePROMs survey via a joint patient portal. Positive outcomes could readily translate this complex intervention into routine clinical care. PRO-P might improve urinary incontinence and QoL in patients with radical prostatectomy through the structured use of ePROMs. ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.

Abstract 4114994: Nursing Management Practice Variations related to Externalized Ventricular and Lumbar Drains

Introduction/Background: Nursing management of neurologic patients may include placement of externalized ventricular drains (EVDs) or lumbar drains (LDs) to monitor/drain cerebrospinal fluid (CSF), but knowledge and practice related to EVD management varies widely, despite a high potential for life-threatening complications. Limited data exists relative to the relationship between intracranial pressure (ICP) and CSF drainage. These gaps may undermine patient safety. Research Question: What are the nursing practices and perspectives regarding management of EVDs and LDs? Methods/Approach: A 16-question multiple-choice/text entry survey was distributed electronically to nurses and advanced practice nurses who were members of the American Association of Neuroscience Nurses. Data analysis included chi-square test for multiple choice responses, and qualitative data was analyzed using a six-step thematic analysis and an inductive approach. Results/Data: Of 219 participants, 42.8% reported roles as Neuroscience ICU nurses, and 39.2% managed an EVD at least 75% of the time. Neuro ICU nurses were most likely to have a patient with an EVD ( p =.002). Approximately 63% of respondents reported consulting with colleagues about EVDs nearly every time they cared for a patient with an EVD. Nurses reported a very high care burden, including re-leveling the transducer 4 or more times per shift (n=76), and re-zeroing every 8 hours (n=72) to assure accurate calibration. Of these 82.2% reported that they re-zeroed the EVD more often to obtain an accurate reading. Approximately 25% reported accidental over-drainage, some with negative outcomes. Many (79.3%) reported caring for patients with LDs, 47.4% to diagnose normal pressure hydrocephalus. The nursing care workload was described as 30-120 minutes each shift. Conclusion: A wide heterogeneity of nursing practices was revealed in EVD and LD management. No standardized nursing care practices have been adopted by nurses for the management of CSF. The complications of these practice variations have been shown to result in untoward patient outcomes. Increased patient morbidity and mortality are linked to catheter infection and over/under drainage of CSF and may be directly related nursing practice. This reveals critical need for improved, standardized care nursing practices in the management of EVDs and LDs, and an empiric understanding of the relationship between intracranial pressure and the volume and rate of CSF drainage.

Expert Opinion for Defining a Severe Bleeding Phenotype to Guide Prophylaxis in Patients with Nonsevere Hemophilia.

Prophylaxis is the standard of care for patients with severe hemophilia, patients with moderate hemophilia, or those with another congenital bleeding disorder that is associated with a severe bleeding phenotype and/or a high risk of spontaneous life-threatening bleeding. Patients with nonsevere hemophilia (factor VIII [FVIII] ≥ 1%) may also have a bleeding phenotype that requires prophylaxis. To date, however, there are no clear criteria as to when prophylaxis is indicated in these patients. Also, the term "severe bleeding phenotype (SBPT)" is neither included in the definitions of the International Society on Thrombosis and Haemostasis (ISTH) nor specified in the World Federation of Hemophilia (WFH) guidelines. Based on our personal experience and available evidence, we propose the criteria we use to define an SBPT and when we consider offering prophylaxis in patients with nonsevere hemophilia. Our proposals can be the basis for discussions in the community about the assessment of SBPT and the initiation of prophylaxis in patients with nonsevere hemophilia without inhibitors.

JCCG ALL-B12: Evaluation of Intensified Therapies With Vincristine/Dexamethasone Pulses and Asparaginase and Augmented High-Dose Methotrexate for Pediatric B-ALL.

The JCCG ALL-B12 clinical trial aimed to evaluate the effectiveness of unvalidated treatment phases for pediatric ALL and develop a safety-focused treatment framework. Patients age 1-19 years with newly diagnosed B-ALL were enrolled in this study. These patients were stratified into standard-risk (SR), intermediate-risk (IR), and high-risk (HR) groups. Randomized comparisons assessed the effectiveness of vincristine (VCR)/dexamethasone pulses in the SR group, evaluated the effects of L-asparaginase (ASP) intensification in the IR group, and compared standard consolidation including block-type treatment with experimental consolidation with high-dose methotrexate (HD-MTX) intensified with VCR and ASP in the HR group. Of 1,936 patients enrolled, 1,804 were eligible for the experimental treatment. The overall 5-year event-free survival and overall survival rates were 85.2% (95% CI, 83.5 to 86.8) and 94.3% (95% CI, 93.1 to 95.3), respectively. The cumulative incidence of relapse and postremission nonrelapse mortality was 13.2% (95% CI, 11.6 to 14.8) and 0.6% (95% CI, 0.3 to 1.0), respectively. Random assignment in the SR group showed no significant benefit from pulse therapy. In the IR group, ASP intensification had limited effects. In the HR group, standard block therapy and HD-MTX yielded equivalent outcomes. The ALL-B12 trial achieved favorable outcomes in a nationwide cohort by stratifying treatment on the basis of risk and balancing treatment intensity. This study not only demonstrated that existing standard of care can be further refined but also indicated that improvement in outcomes with intensified chemotherapy has reached a plateau.

Satisfactory outcomes following a second autologous hematopoietic cell transplantation for multiple myeloma in poor stem cell mobilizers: a retrospective study on behalf of the Chronic Malignancies Working Party of the EBMT.

Autologous hematopoietic cell transplants (auto-HCTs) remain the standard of care for transplant-eligible MM patients. The general practice has been to undergo upfront apheresis following induction to collect sufficient number of CD34+ cells to facilitate two auto-HCTs. However, 5-30% of MM patients do not initially mobilise a sufficient number of hematopoietic stem cells and are classified as poor mobilizers (PM). We compared the baseline characteristics and outcomes of 61 PMs and 816 non-PM patients who underwent a second auto-HCT and who were enrolled in the non-interventional CALM study (NCT01362972). Only patients who collected CD34+ prior to auto-HCT1 were included. Auto-HCT2 comprised both tandem and salvage transplants. PMs were re-mobilized with plerixafor (n = 24, 39.3%) or non-plerixafor-based regimens (n = 37, 60.7%). There were no significant differences in engraftment, progression-free survival (PFS) or overall survival (OS) after the second auto-HCT between PM and non-PM patients. There was a trend to shorter PFS in PM patients undergoing salvage auto-HCT (median 9.6 vs. 12.9 months; p = 0.08) but no significant difference in OS. The median OS was 41.1 months for PM and 41.2 months for non-PM patients (p = 0.86). These data suggest that salvage mobilization is effective and does not affect overall outcomes after a second auto-HCT.

Abstract 4122590: Sex Differences in the Prescription of P2Y12 Inhibitor Agents Following Percutaneous Coronary Intervention

Background: There remain significant gender inequalities in the delivery of healthcare. Third generation P2Y12 inhibitors (P2Y12i), Prasugrel and Ticagrelor, are the standard of care for dual antiplatelet therapy (DAPT), especially in the setting of acute coronary syndrome (ACS). We hypothesized that women are less likely to be prescribed 3 rd generation P2Y12i than clopidogrel, due to concealed gender inequalities. Methods: We examined gender differences in post percutaneous coronary intervention (PCI) care in a cohort of 12,354 PCI cases from all 14 hospitals within the Steward Health Care system in the United States of America (USA). After removal of duplicates, 10,415 patients were included in the final analysis, with 7,191 males (69.04%) and 3,224 (30.96%) females. We conducted statistical analyses using the Chi-Square test of independence to explore associations between categorical variables, and logistic regression analysis to model the probability of clopidogrel prescription based on patient characteristics, adjusting for confounders. Results: We found that women were less likely than men to be prescribed 3 rd generation P2Y12i compared to clopidogrel with an odds ratio (OR) of 0.74 (CI 0.69-0.80, p<0.001). We adjusted for the following variables: age, weight, insurance type, number of stents, and relevant co-morbidities. The association remained significant with an OR of 0.83 (CI 0.76-0.90, p<0.001). In a subgroup of ACS patients, the association was also statistically significant with an OR of 0.77 (CI 0.67-0.88, p<0.001). Conclusions: Our study reveals that significant gender disparities exist in the prescription of P2Y12i after PCI, with women having a greater likelihood of being prescribed clopidogrel compared to more effective and guideline directed, 3 rd generation agents. This association held true after accounting for confounding variables including older age and an increased prevalence of co-morbidities in the female group. Our conclusions are likely to have been influenced by unmeasured socioeconomic factors, such as household income and medication costs. Therefore, further research ought to be conducted to better understand the reasons behind the association observed.

The effects of free dance versus hatha yoga on quality of life and motor and non-motor symptoms in people with Parkinson's disease: protocol study for a randomized clinical trial

Objective: To describe a protocol comparing the effects of free dance, hatha yoga, and a control group on quality of life, motor and non-motor symptoms in people with Parkinson's disease (PwP). Methods: This is a randomized three-arm study. Inclusion criteria will be people with clinically diagnosed Parkinson's disease (PD), ≥ 45 years old, and in stages I to IV of the Hoehn and Yahr Disability Scale (HY). Who do not reach the cut-off point of the Montreal Cognitive Assessment (MoCA) and classified in stage V of the HY will be excluded. The interventions will last 60 minutes, twice a week, progressing from light to vigorous intensity. The primary outcome will be quality of life assessed by the Parkinson's Disease Questionnaire (PDQ39). Secondary outcomes will include the Unified Parkinson's Disease Rating Scale (UPDRS), the evaluation of motor and physical function such as shoulder and hip range of motion (goniometer), cardiorespiratory fitness (six-minute walk test), balance (MiniBESTest), as well as non-motor aspects such as anxiety (Beck Anxiety Inventory), self-esteem (Rosenberg Self-Esteem Scale), cognition (MoCA), hope (Herth Hope Scale), fecal incontinence (Fecal Incontinence Quality of life), urinary incontinence (International Consultation on Incontinence Questionnaire - Short Form), and depressive symptoms (Beck Depression Inventory). Data will be collected at baseline and post-intervention. Discussion: If study interventions are deemed effective compared to standard of care (i.e. control group), the present study will advance current knowledge on non-pharmacological therapeutic strategies for People with Parkinson. Study registered RBR-54s92mh on 02/29/24.