Standard Of Care For Patients Research Articles

Revolutionizing Periodontics: The Impact of Digitalization on Diagnosis and Treatment

The objective of this review is to explore the impact of digitalization on periodontics, with a particular focus on its role in enhancing both diagnosis and treatment. Drawing from a range of recent technological advancements, the study reviews the implementation of advanced imaging techniques and artificial intelligence (AI) in clinical practice. Key digital tools such as cone-beam computed tomography (CBCT), digital intraoral scanners, computer-aided design and manufacturing (CAD/CAM), and 3D printing are examined for their contributions to the field. The results indicate that the integration of CBCT and digital intraoral scanners enables precise early detection of periodontal diseases, while AI refines diagnostics through predictive analytics and facilitates personalized treatment plans. Additionally, CAD/CAM and 3D printing technologies support minimally invasive procedures and the creation of custom dental prosthetics, leading to improved patient outcomes. Overall, the review highlights the significant potential of digital tools to optimize clinical workflows and elevate patient care standards, in alignment with contemporary policies aimed at advancing healthcare through technology.

Racial and Ethnic Disparities in Autologous Hematopoietic Cell Transplantation Utilization in Multiple Myeloma Have Persisted Over Time Even After Referral to a Transplant Center

Despite the use of autologous hematopoietic cell transplantation (AHCT) in treatment of multiple myeloma (MM) for almost 40 years and its persistence as standard of care in transplantation-eligible patients with MM even after the advent of novel agents, AHCT remains underutilized, especially in racial and ethnic minority populations. As part of a multipronged effort to quantify disparities in AHCT utilization in MM by race and ethnicity and over time in our own cancer center, we conducted an institutional review of all new patients seen at an academic transplant center for consultation for MM between 2012 and 2022, to calculate AHCT utilization and investigate the factors associated with AHCT utilization. Race and ethnicity were self-reported. Baseline characteristics were analyzed in 3 groups: non-Hispanic White (NHW), non-Hispanic Black (NHB), and Others. Reasons for not undergoing AHCT in the EHR were recorded. Multivariate analyses evaluated the effect of group on AHCT utilization, controlling for covariates related to patients not undergoing AHCT by overall cohort and consult period. Of the 1266 patients, 13.4% were NHB. The median age at consult was 66 (IQR, 23-97) years overall, 66 (IQR, 23-97) years for NHWs, 63 (IQR, 25-85) years for NHBs, and 59.5 (IQR, 31-79) years for Others (P < .01). AHCT utilization was 76% overall, 64.7% in NHBs, 76.8% in Others, and 77.8% in NHWs (P < .01). Age, cytogenetics, stage, comorbidities, and time from diagnosis to consult were associated with receipt of AHCT. From 2012-2017 to 2018-2022, NHB AHCT utilization increased from 57.5% to 69.8% (P = .10). For those who did not receive AHCT, patient preference, older age, comorbidity, early mortality, and lack of caregiver support were the most frequently documented reasons. The NHW group had greater AHCT utilization compared to the NHB group (odds ratio [OR], 3.32; 95% confidence interval [CI], 2.17-5.08; P < .0001). Absent cardiac (OR, 1.88; 95% CI, 1.35-2.62; P = .0002) or renal comorbidity (OR, 3.23; 95% CI, 2.03-5.15; P < .0001) was associated with receipt of AHCT. Older age at consult (OR, .89; 95% CI, .87-.90; P < .0001) and longer time from diagnosis to consult (OR, .97; 95% CI, .95-.98; P < .0001) were associated with lower AHCT utilization. While AHCT utilization increased from 2012-2017 to 2018-2022 in NHBs compared to NHWs, it remained significantly lower. Racial and ethnic AHCT underutilization has improved over time, but disparities persist. Younger age at consult, shorter time from diagnosis to consult, and lack of cardiac and renal comorbidities also are associated with AHCT utilization.

Impact of a 12-week high-intensity interval training intervention on cardiac structure and function after COVID-19 at 12-month follow-up.

In patients previously hospitalised for COVID-19, a 12-week high-intensity interval training (HIIT) intervention has previously been shown to increase left ventricular mass (LVM) immediately after the intervention. In the present study, we examined the effects of the same HIIT scheme on LVM, pulmonary diffusing capacity, symptom severity and functional capacity at 12-month follow-up. In this investigator-blinded, randomised controlled trial, 12weeks of a supervised HIIT scheme (4×4min, three times a week) was compared to standard care (control) in patients recently discharged from hospital due to COVID-19. At inclusion and at 12-month follow-up, LVM was assessed by cardiac magnetic resonance imaging (cMRI, primary outcome), while pulmonary diffusing capacity for carbon monoxide (DLCOc, secondary outcome) was examined by the single-breath method. Symptom severity and functional status were examined by the Post-COVID-19 Functional Scale (PCFS) and King's Brief Interstitial Lung Disease (KBILD) questionnaire score. Of the 28 patients assessed at baseline, 22 completed cMRI at 12-month follow-up (12.4±0.6months after inclusion). LVM was maintained in the HIIT but not the standard care group, with a mean between-group difference of 9.68 [95% CI: 1.72, 17.64] g (P=0.0182). There was no differences in change from baseline to 12-month follow-up between groups in DLCOc % predicted (-2.45 [-11.25, 6.34]%; P=0.578). PCFS and KBILD improved similarly in the two groups. In individuals previously hospitalised for COVID-19, a 12-week supervised HIIT scheme resulted in a preserved LVM at 12-month follow-up but did not affect pulmonary diffusing capacity or symptom severity.

Effects on patient activation of eHealth support in addition to standard care in patients after radical prostatectomy: Analysis of secondary outcome from a randomized controlled trial.

Prostate cancer is often treated with radical prostatectomy, but surgery can leave patients with side effects. Patients who actively take part in their rehabilitation have been shown to achieve better clinical outcomes. eHealth support has the potential to increase patient activation, but has rarely been evaluated in long-term randomized controlled trials. Therefore, we evaluated the effects on patient activation of eHealth support (electronic Patient Activation in Treatment at Home, ePATH) based on motivational theory. The aim was to investigate the effects of eHealth support on patient activation at 6 and 12 months after radical prostatectomy, compared with standard care alone, and associations with baseline patient activation and depression. A multicentre randomized controlled trial with two study arms was conducted. Men planned for radical prostatectomy at three county hospitals in southern Sweden were included and randomized to the intervention or control group. The effects of ePATH on the secondary outcome, patient activation, were evaluated for one year after surgery using the patient activation measure and analysed using a linear mixed model. The study included 170 men during 2018-2019. In the intervention group, 64% (53/83) used ePATH. The linear mixed model showed no significant differences between groups in patient activation [β -2.32, P .39; CI -7.64-3.00]. Baseline patient activation [β 0.65, P < .001; CI 0.40-0.91] and depression [β -0.86, P .03; CI -1.64- -0.07] statistically impacted patient activation scores over one year. ePATH had no impact on patient activation during long-term prostate cancer rehabilitation. However, patient activation at baseline and depression scores significantly influenced patient activation, underlining the need to assess these aspects in prostate cancer surgery rehabilitation. ISRCTN Registry ISRCTN18055968, (07/06/2018); https://www.isrctn.com/ISRCTN18055968; International Registered Report Identifier: RR2-10.2196/11625.

Effect of sodium–glucose co-transporter-2 inhibitors on survival free of organ support in patients hospitalised for COVID-19 (ACTIV-4a): a pragmatic, multicentre, open-label, randomised, controlled, platform trial

Patients hospitalised for COVID-19 are at risk for multiorgan failure and death. Sodium-glucose co-transporter-2 (SGLT2) inhibitors provide cardiovascular and kidney protection in patients with cardiometabolic conditions and could provide organ protection during COVID-19. We aimed to investigate whether SGLT2 inhibitors can reduce the need for organ support in patients hospitalised for COVID-19. This pragmatic, multicentre, open-label, randomised, controlled, platform trial was conducted across 63 sites in the USA, Spain, Brazil, Italy, and Mexico. Patients aged at least 18 years hospitalised for COVID-19 (moderate or severe illness) were randomly assigned (1:1), via an interactive voice system or web-response system, to receive locally available SGLT2 inhibitor (administered orally, once daily) plus standard-of-care or standard-of-care for 30 days. The primary outcome was organ support-free days evaluated through 21 days, assessed using intention-to-treat approach. This trial is registered on ClinicalTrials.gov, NCT04505774. The first patient was randomly assigned to the SGLT2 inhibitor domain on Dec 3, 2021. On March 31, 2023, at the recommendation of the data and safety monitoring board, enrolment in the SGLT2 inhibitor domain for both moderately and severely ill hospitalised patients was stopped prematurely for futility due to a low likelihood of finding a treatment benefit. The final randomised population consisted of 575 patients (mean age 72 years [SD 13], 242 (42%) female and 154 (27%) Hispanic; 504 in the moderate illness group and 71 in the severe illness group). 573 patients had a known 21-day outcome; 215 (75%) of 285 patients in the SGLT2 inhibitor plus standard-of-care group did not require respiratory or cardiovascular organ support versus 231 (80%) of 288 patients in the standard-of-care group. The adjusted odds ratio (OR) for an SGLT2 inhibitor effect on organ support-free days was 0·74 (95% Credible Interval [CrI] 0·48-1·13; where OR higher than 1 indicated treatment benefit, yielding a posterior probability of futility P(OR <1·2) of 99% and a posterior probability of inferiority P(OR<1·0) of 91%). There were 37 deaths (13%) in the SGLT2 inhibitor plus standard-of-care group and 42 deaths (15%) in the standard-of-care group at 90 days (hazard ratio 0·91 [95% CrI 0·58-1·43], probability of hazard ratio <1 of 66%). No safety concerns were observed with SGLT2 inhibitors, including no cases of ketoacidosis. SGLT2 inhibitors did not significantly increase days free of organ support or reduce mortality in patients hospitalised with COVID-19. SGLT2 inhibitors were well tolerated with no observed safety concerns. Overall, these findings do not support the use of SGLT2 inhibitors as standard care in patients hospitalised with COVID-19. National Institutes of Health.

Raising the voice of specialist stoma care nurses: a call for a national strategy in stoma care

Specialist stoma care nurses (SSCNs) are highly educated professionals who play a critical role in the care of people living with a stoma. However, they experience some unique challenges. Currently in the UK, stoma care has no national standards, targets or best practice pathway, resulting in significant variation and an undervalued service. As members of an evidence-based profession, SSCNs need to demonstrate their value. Specialist nurses in cancer care and inflammatory bowel disease are supported by nationally, with pathways, targets and standards of care, as well as career and education frameworks. This system could be used for SSCNs. A national approach is needed to develop an evidence-based best-practice pathway, commissioned and implemented across the UK for all stoma patients and with SSCNs at its heart. SSCNs need to demonstrate their value through data and evidence. Working with Getting it Right First Time, a taskforce aims to review the evidence and establish minimum standards of care for all stoma patients. SSCNs should be co-ordinators and drivers of change at the highest level of national innovation, policy and decision-making. The work of SSCNs should be is recognised and valued because what they do matters.

Omission of Axillary Lymph Node Dissection in Patients with Residual Nodal Disease After Neoadjuvant Chemotherapy.

Axillary management after neoadjuvant chemotherapy (NAC) is evolving but axillary lymph node dissection (ALND) remains the standard of care for patients with residual nodal disease. The results of the Alliance A011202 trial evaluating the oncologic safety of ALND omission in this cohort are pending but we hypothesize that ALND omission is already increasing. The National Cancer Database was queried to identify patients diagnosed with cT1-3N1M0 breast cancer who underwent NAC and had residual nodal disease (ypN1mi-2) from 2012 to 2021. Temporal trends in omission of completion ALND were assessed annually. Multivariable logistic and Cox regression models were used to identify factors associated with ALND omission and overall survival (OS), respectively. A total of 6101 patients were included; the majority presented with cT2 disease (57%), with 69% HER2+, 23% triple-negative, and 8% hormone receptor-positive/HER2-. Overall, 34% underwent sentinel lymph node biopsy (SLNB) alone. Rates of ALND were the lowest in the last 4years of observation. After adjustment, treatment at community centers (vs. academic) and lower pathologic nodal burden were associated with omission of ALND. ALND omission was associated with a higher unadjusted OS (5-year OS: 86% SLNB alone vs. 84% ALND; log-rank p=0.03), however this association was not maintained after adjustment. Despite the impending release of the Alliance A011202 results, omission of ALND in patients with residual nodal disease after NAC is increasing. This practice appears more prominent in community centers and in patients with a lower burden of residual nodal disease. No association with OS was noted.

Heterogeneity of Treatment Effects of Laser Epilation on Pilonidal Disease Recurrence: A Randomized Clinical Trial.

To investigate the heterogeneity of treatment effects (HTE) of laser epilation in preventing pilonidal disease recurrence through analysis of prespecified clinical factors. Pilonidal disease is a common, painful disease affecting 1% of the population aged 15 to 30 years with postoperative recurrence rates as high as 30% to 40%. Single-institution randomized controlled trial from September 2017 to September 2022 with 1-year follow-up, including patients aged 11 to 21 years with pilonidal disease undergoing gluteal cleft laser epilation and standard care (improved hygiene and mechanical or chemical depilation) or standard care alone. In total, 302 patients were enrolled with 151 randomized to each intervention. 1-year follow-up was available for 96 patients in the laser group and 134 in the standard care group. There were no significant differences in treatment effects based on sex, body mass index, previous disease, prior surgical excision, or annual household income (all P > 0.05). HTE was identified by race and ethnicity (P = 0.005) and health insurance type (P = 0.001). Recurrence among non-Hispanic white patients was 4% (3/75) with laser treatment and 31.6% (31/98) with standard care versus 38.9% (7/18) with laser treatment and 38.2% (13/34) with standard care among all other racial/ethnic groups. Recurrence rates among privately insured patients were 4.0% (3/75) with laser treatment and 33.3% (29/87) with standard care versus 36.8% (7/19) with laser treatment and 29.7% (11/37) with standard care in patients with public insurance. The effectiveness of laser epilation to reduce pilonidal disease recurrence rates may vary based on race and ethnicity and insurance type. Additional studies are warranted to investigate this potential HTE.

A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia

BackgroundBenign Prostrate Hyperplasia (BPH) is a progressive disease of ageing men that may be associated with enlargement of the prostate and lower urinary tract symptoms (LUTS). Herbal/Nutraceutical formulations in addition to standard of care (SOC) could alleviate the symptoms, and thus improve the quality of life of patients. ObjectivesTo evaluate safety & efficacy of nutraceutical tablet as an adjuvant with SOC. Materials and MethodsThis was a prospective, randomized two-arm study aimed to assess the safety and efficacy of Herbal/Nutraceutical Formulation (IP) + SOC versus only SOC, in BPH patients. The primary efficacy endpoint was the change in international prostate symptom score (IPSS) within and between two arms. The safety was evaluated in terms of adverse events and change in prostate specific antigen (PSA) levels. Results140 eligible patients (70 / arm) were evaluated for efficacy and safety endpoints. The baseline characteristics of patients in two arms differed nonsignificantly. The change in IPSS-storage, voiding and QoL scores, from day 1 to 90 were statistically significant in both the arms (p < 0.0001). However, by day 90, the change in these scores in SOC+IP arm were significantly higher than that of SOC arm. Further, the change in International Index of Erectile Function (IIEF) scores was significant in SOC+IP arm (p < 0.05), while non-significant in SOC arm. The adverse events non-significantly differed between two arms. ConclusionThe herbal/nutraceutical formulation combined with SOC are safe and effective for the treatment of BPH. The combination therapy was effective in reducing urine-related symptoms and improving the QoL of BPH patients.

Low dose lenalidomide versus placebo in non-transfusion dependent patients with low risk, del(5q) myelodysplastic syndromes (SintraREV): a randomised, double-blind, phase 3 trial

Lenalidomide is the standard of care for patients who are transfusion dependent with chromosome 5q deletion (del[5q]) myelodysplastic syndromes. In the SintraREV trial, we aimed to investigate whether an early intervention of low lenalidomide doses for 2 years could delay transfusion dependency in patients with anaemia who were not transfusion dependent. This randomised, double-blind, phase 3 trial, was conducted at 22 sites (University Hospitals) in Spain, France, and Germany. Eligible patients were aged 18 years or older diagnosed with low-risk or intermediate-1-risk del(5q) myelodysplastic syndromes with non-transfusion-dependent anaemia (according to the IPSS), were erythropoietin-stimulating agents naive, and had an ECOG performance status of 2 or less. Patients were randomly assigned (2:1) by means of a telephone system to receive lenalidomide 5 mg daily in 28-day cycles versus placebo for 2 years. The primary endpoint was time to transfusion dependency based on blinded independent central review. Analysis were by intent-to-treat (ITT) and evaluable population. Safety analyses included all participants who received at least one dose of treatment. This trial is registered with ClinicalTrials.gov (NCT01243476) and EudraCT (2009-013619-36) and is complete. Between Feb 15, 2010, and Feb 21, 2018, 61 patients were randomly assigned to receive lenalidomide (n=40; two did not receive treatment) or placebo (n=21). The median age was 72·2 (IQR 65·4-81·9) years, 50 (82%) patients were female, and 11 (18%) were male. The median follow-up time was 60·6 (IQR 32·1-73·9) months. Regarding primary endpoint, median time to transfusion dependency was not reached (95% CI not applicable) in the lenalidomide group versus 11·6 months (95% CI 0·00-30·11) in the placebo group (p=0·0027). Lenalidomide significantly reduced the risk of transfusion dependency by 69·8% (hazard ratio 0·302, 95% CI 0·132-0·692; p=0·0046). The most frequent treatment-related adverse event was neutropenia, occurring in 24 (63%) of 38 patients in the lenalidomide group (grade 3 and 4 in 17 [45%] patients and one [3%], respectively) and in four (19%) of 21 patients in the placebo group (grade 3 in one [5%] patient). Thrombocytopenia was detected in seven (18%) of 38 patients receiving lenalidomide (grade 3 in two [5%] patients). Regarding the non-haematological toxicity, skin disorders (rash nine [23%] of 38 patients) were the most frequently described toxicities among patients receiving lenalidomide, being grade 3 in one (3%) of 38 patients. 19 serious adverse events were reported in 13 patients, 18 in the lenalidomide group and one in the placebo group, five of which were potentially related to the study drug. No treatment-related deaths were identified. An early approach with low doses of lenalidomide across two years delays the time to transfusion dependency and improves the rate and quality of the responses, with a manageable safety profile in patients who are non-transfusion dependent with del(5q) low-risk myelodysplastic syndromes. Bristol Myers Squibb.

Tocilizumab in combination with standard of care in patients with severe COVID-19 pneumonia: Efficacy and safety from a phase 3 clinical trial in Japan

BackgroundCoronavirus disease 2019 (COVID-19) is characterized by high interleukin-6 levels. Clinical data supporting tocilizumab, a monoclonal antibody that targets interleukin-6 receptor-alpha, for treating Japanese patients with severe COVID-19 pneumonia are needed. MethodsThis single-arm phase 3 study investigated tocilizumab (8 mg/kg) plus standard of care (SOC) in Japanese patients hospitalized with severe COVID-19 pneumonia. Clinical status was assessed using a 7-category ordinal scale on day 28 (primary endpoint) and day 14 (secondary endpoint). Other secondary endpoints were time to improvement (≥2 category improvement) and time to hospital discharge. Safety was assessed as the incidence of adverse events (AEs). ResultsAmong 48 patients enrolled, 44 (91.7 %) scored ≥3 on the 7-category ordinal scale at baseline. At day 28, 35 patients (72.9 %) scored 1 and 5 (10.4 %) scored 7 on the 7-category ordinal scale; 36 (75.0 %, 95 % confidence interval [CI]: 60.40 %–86.36 %) and 39 (81.3 %, 95 % CI: 67.37 %–91.05 %) patients achieved ≥2- and ≥1-category improvement, respectively; 6 patients (12.5 %, 95 % CI: 4.73 %–25.25 %) demonstrated ≥1-category worsening. At day 14, 25 (52.1 %, 95 % CI: 37.19 %–66.71 %) and 33 patients (68.8 %, 95 % CI: 53.75 %–81.34 %) achieved ≥2- and ≥1-category improvement, respectively; 5 patients (10.4 %, 95 % CI: 3.47 %–22.66 %) demonstrated ≥1-category worsening. Median times (95 % CI) to improvement and hospital discharge were 11 (9–15) and 15 (11–18) days, respectively. Forty patients (83.3 %) experienced AEs; the incidence of ≥grade 3 AEs was 25 %. ConclusionTocilizumab plus SOC may provide improved clinical status in Japanese patients with severe COVID-19 pneumonia; no new safety signals were identified.

854MO Avelumab-cetuximab-radiotherapy (RT) versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Final analysis of randomized phase III GORTEC 2017-01 REACH trial

854MO Avelumab-cetuximab-radiotherapy (RT) versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Final analysis of randomized phase III GORTEC 2017-01 REACH trial

249. OVERALL SURVIVAL OF PATIENTS WITH ESOPHAGEAL CANCER TREATED WITH DEFINITIVE CHEMORADIOTHERAPY: INSIGHTS FROM A RETROSPECTIVE STUDY

Abstract Background Neoadjuvant chemoradiotherapy followed by esophagectomy is the standard of care for patients with locally advanced esophageal cancer. However, definitive chemoradiotherapy (dCRT) may be considered as an alternative for those with unresectable disease, cervical location of the tumor or if a non-surgical approach is preferred based on the patient's condition. Heterogeneity in indications for dCRT makes it challenging to draw generalized conclusions regarding outcomes and survival. The aim of this study was to evaluate overall survival (OS) and recurrence patterns in patients with specified homogeneous indications for dCRT. Methods Patients with esophageal cancer treated with dCRT (50.4 Gy radiotherapy concomitant with 6 cycles of carboplatin/paclitaxel) between 2012-2022 in a tertiary referral center were identified from our institutional database. Primary endpoint was OS calculated from date of diagnosis until date of death or last day of follow-up, using the Kaplan Meier method. Secondary endpoints included the proportion of patients that completed the dCRT regimen, 30- and 90-day mortality following dCRT and disease recurrence. Results 162 patients were included, median follow-up was 74.6 months (IQR 46.2-99.3). The full dCRT regimen was completed by 116 (73.9%) patients. The 30- and 90-day mortality were 2.5% and 8.3%, respectively. The median OS was 23.7 months (95% CI 6.65-40.66) for cervical location of the tumor, 13.7 months (95% CI 7.92-29.8) for irresectable disease, 28.2 months (95% CI 12.10-44.22) for patients unfit for surgery and 20.6 months (95% CI 14.14-27.13) for those with preference for dCRT (p=0.15). Disease recurrence was observed in 74 patients (46%), located locoregional (46%), distant (19%) or both locoregional and distant (35%). Conclusion(s) Treatment with dCRT resulted in a 5-year OS of 35% and is associated with a high 90-day mortality. Disease recurrence was mostly locoregional located and was observed in 46% of patients. This emphasizes the critical necessity for enhanced treatment strategies centered on improving locoregional disease control.

A Retrospective Analysis of Urethroplasty and Medical Malpractice

ObjectivesTo review malpractice suits stemming from urethroplasty intervention, which is the standard of care for patients suffering from urethral strictures. MethodsThis retrospective study analyzed the LexisNexis and Westlaw databases between 1980 and 2024. Each database was queried with “urethroplasty” which yielded 48 cases and 20 jury verdicts/settlements in the LexisNexis database and 46 cases and 14 jury verdicts in the Westlaw database. Selected cases were reviewed variables including chief allegation, litigation location, plaintiff demand, plaintiff award, and verdict. Exclusion criteria included but were not limited to lawsuits regarding non-urologic surgery necessitating urethroplasty and litigation based on traumatic injury necessitating urethroplasty. ResultsAfter manual review of 128 cases in the LexisNexis and Westlaw databases, 12 met inclusion criteria. 5 (42%) cases sued for deformation of the genitalia after urethroplasty, 2 (17%) sued for failure of informed consent, 2 (17%) sued for erectile dysfunction, 1 (8%) sued for a post-operative venous thrombosis, 1 (8%) sued for post-operative infection, and 1 (8%) sued for failure to treat. 6 (50%) cases resulted in plaintiff awards; 3 of these were settled before a final verdict. Plaintiff awards varied from $72,500 - $810,000. Of the twelve cases, 2 (17%) occurred in California and 2 (17%) occurred in Illinois; the remaining locations were isolated. ConclusionsThe most common cause of litigation following urethroplasty was centered on the perceived deformation of the genitalia after urethroplasty, which underscores the significance of urologists setting realistic expectations for patients with thorough pre-operative counseling.

Best Medical Therapy for Asymptomatic Carotid Stenosis: Imminent or Ineffective?

Carotid artery disease accounts for approximately 20% of all ischemic strokes, a major cause of morbidity, and the fifth leading cause of death in United States. Landmark trials in the 1990s such as Asymptomatic Carotid Atherosclerosis Study (ACAS) and Asymptomatic Carotid Surgery Trial (ACST) establish carotid endarterectomy (CEA) plus best medical therapy (BMT) as the standard of care for patients with asymptomatic carotid stenosis over 60%. However, advances in medical therapy and the emergence of carotid artery stenting (CAS) have prompted a reevaluation of treatment efficacy. Recent studies have questioned the superiority of CEA over BMT alone in reducing stroke risk, suggesting no significant difference in outcomes with contemporary medical management. Additionally, analysis from the US Department of Veterans Affairs indicated minimal net benefit of CEA over BMT when accounting for all-cause mortality. Comparative studies have found no significant difference in long-term stroke free survival between CEA and CAS. However, procedural risks vary, with higher myocardial infarction rates associated with CEA and higher stroke rates with CAS. Identifying high-risk plaques and patient-specific risk factors remains crucial. Meta-analyses have highlighted features such as neovascularization and lipid rich cores as predictors of stenosis progression and ischemic events. Ongoing research, particularly the CREST-2 trial, aims to provide clear guidance on the optimal treatment of asymptomatic carotid stenosis. This trial emphasizes stringent adherence to modern BMT protocols and includes comprehensive lifestyle modification programs. The evolving landscape of medical and surgical interventions necessitates continuous evaluation to optimize treatment strategies for asymptomatic carotid stenosis, which is the impetus for this review. Future findings from ongoing trials are expected to refine current guidelines and improve patient outcomes.

The UK resuscitative endovascular balloon occlusion of the aorta in trauma patients with life-threatening torso haemorrhage: the (UK-REBOA) multicentre RCT.

The most common cause of preventable death after injury is haemorrhage. Resuscitative endovascular balloon occlusion of the aorta is intended to provide earlier, temporary haemorrhage control, to facilitate transfer to an operating theatre or interventional radiology suite for definitive haemostasis. To compare standard care plus resuscitative endovascular balloon occlusion of the aorta versus standard care in patients with exsanguinating haemorrhage in the emergency department. Pragmatic, multicentre, Bayesian, group-sequential, registry-enabled, open-label, parallel-group randomised controlled trial to determine the clinical and cost-effectiveness of standard care plus resuscitative endovascular balloon occlusion of the aorta, compared to standard care alone. United Kingdom Major Trauma Centres. Trauma patients aged 16 years or older with confirmed or suspected life-threatening torso haemorrhage deemed amenable to adjunctive treatment with resuscitative endovascular balloon occlusion of the aorta. Participants were randomly assigned 1 : 1 to: standard care, as expected in a major trauma centre standard care plus resuscitative endovascular balloon occlusion of the aorta. Primary: Mortality at 90 days. Secondary: Mortality at 6 months, while in hospital, and within 24, 6 and 3 hours; need for haemorrhage control procedures, time to commencement of haemorrhage procedure, complications, length of stay (hospital and intensive care unit-free days), blood product use. Health economic: Expected United Kingdom National Health Service perspective costs, life-years and quality-adjusted life-years, modelled over a lifetime horizon. Case report forms, Trauma Audit and Research Network registry, NHS Digital (Hospital Episode Statistics and Office of National Statistics data). Ninety patients were enrolled: 46 were randomised to standard care plus resuscitative endovascular balloon occlusion of the aorta and 44 to standard care. Mortality at 90 days was higher in the standard care plus resuscitative endovascular balloon occlusion of the aorta group (54%) compared to the standard care group (42%). The odds ratio was 1.58 (95% credible interval 0.72 to 3.52). The posterior probability of an odds ratio > 1 (indicating increased odds of death with resuscitative endovascular balloon occlusion of the aorta) was 86.9%. The overall effect did not change when an enthusiastic prior was used or when the estimate was adjusted for baseline characteristics. For the secondary outcomes (3, 6 and 24 hours mortality), the posterior probability that standard care plus resuscitative endovascular balloon occlusion of the aorta was harmful was higher than for the primary outcome. Additional analyses to account for intercurrent events did not change the direction of the estimate for mortality at any time point. Death due to haemorrhage was more common in the standard care plus resuscitative endovascular balloon occlusion of the aorta group than in the standard care group. There were no serious adverse device effects. Resuscitative endovascular balloon occlusion of the aorta is less costly (probability 99%), due to the competing mortality risk but also substantially less effective in terms of lifetime quality-adjusted life-years (probability 91%). The size of the study reflects the relative infrequency of exsanguinating traumatic haemorrhage in the United Kingdom. There were some baseline imbalances between groups, but adjusted analyses had little effect on the estimates. This is the first randomised trial of the addition of resuscitative endovascular balloon occlusion of the aorta to standard care in the management of exsanguinating haemorrhage. All the analyses suggest that a strategy of standard care plus resuscitative endovascular balloon occlusion of the aorta is potentially harmful. The role (if any) of resuscitative endovascular balloon occlusion of the aorta in the pre-hospital setting remains unclear. Further research to clarify its potential (or not) may be required. This trial is registered as ISRCTN16184981. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/199/09) and is published in full in Health Technology Assessment; Vol. 28, No. 54. See the NIHR Funding and Awards website for further award information.

PE104 A retrospective study assessing the use of Naloxegol vs. standard care in patients undergoing robot-assisted radical cystectomy

PE104 A retrospective study assessing the use of Naloxegol vs. standard care in patients undergoing robot-assisted radical cystectomy

Individualized responses to acupuncture in premature ovarian insufficiency: A study protocol for a nested case-control trial with transcriptome analysis

BackgroundPremature ovarian insufficiency (POI), a modifiable cause of infertility with substantial implications for women's well-being, prompts the exploration of efficacious adjunctive treatments. Acupuncture emerges as a promising therapeutic avenue; however, the nuanced effects of acupuncture in POI warrant more comprehensive investigation. The intricate mechanisms dictating individualized responses remain elusive. This trial seeks to assess the effectiveness of acupuncture as an adjunctive treatment for POI, concurrently delving into the impact of transcriptome analysis on peripheral blood to unravel the underpinnings of these individual variations. The overarching objective is to enrich our comprehension of acupuncture's therapeutic potential in the context of POI, with a view to advancing holistic patient care. Methods/designConstituting an open-label, nested case-control study, this research endeavors to enroll 108 women diagnosed with POI. Participants will be randomly assigned in a 1:1 ratio to either the study group or the control group, each comprising 54 subjects. Ten patients from each group meeting specific criteria will partake in transcriptome analysis. An additional 10 subjects meeting the study criteria will form a healthy control group. The study group will exclusively undergo acupuncture treatment, while the control group will solely receive Fenmutong. Acupuncture sessions, administered thrice weekly across three menstrual cycles from the fifth day of menstruation, constitute the intervention. Primary outcome measurement rests on Follicle-Stimulating Hormone (FSH) levels, supplemented by secondary assessments encompassing biometric features, hormone biomarkers, anxiety and depression scores, and transcriptome analysis. Baseline measurements precede intervention, with post-intervention evaluations following. The study endeavors to discern specific genes linked to individualized responses to acupuncture. Data analysis, employing SPSS 25.0 software, incorporates a meticulous examination of peripheral blood samples for transcriptome analysis. The investigation aspires to shed light on genetic determinants influencing the effects of acupuncture on women with POI, thereby fostering elevated standards in patient care and management. DiscussionThis study pivots on the principal objective of scrutinizing the efficacy of acupuncture as an adjunctive treatment for POI. Beyond effectiveness, it undertakes an exploration of the intricate mechanisms underlying the diverse responses exhibited by individuals in the context of acupuncture, augmenting the depth of understanding in this therapeutic domain.

Hypofractionated Dose Escalation Radiotherapy for High-Risk Prostate Cancer: the survival analysis of the Prostate Cancer Study-5 (PCS-5), a GROUQ-led phase III trial

Background and objectiveProstate Cancer Study 5 (PCS5) compared conventional fractionated radiotherapy (CFRT) with hypofractionated radiotherapy (HFRT) in high-risk prostate cancer (PCa) patients, hypothesizing similar toxicity and survival outcomes. This report presents the efficacy analysis. MethodsPCS5 is a Canadian multicenter, open-label, phase 3 randomized control trial. Men with histologically proven, clinically localized PCa with one or more high-risk features (T3/T4, Gleason score ≥8, and prostate-specific antigen >20) were eligible. Patients were randomized 1:1 to CFRT (76 Gy/38 fractions [Fx] to the prostate and 46 Gy/23 Fx to the pelvic lymph nodes [PLNs]) or HFRT (68 Gy/25 Fx to the prostate and 45 Gy/25 Fx to the PLNs) and 28 mo of androgen suppression. The primary endpoint was toxicity; secondary endpoints included survival outcomes. Key findings and limitationsOf 329 patients, 164 were randomized to HFRT and 165 to CFRT, with 159 in the HFRT arm and 160 in the CFRT arm included in survival analyses. At the 5-yr median follow-up, there were no significant differences in overall survival (OS; 90.3% vs 89.7%; risk ratio [RR]: 1.01; 95% confidence interval [CI]: 0.93–1.09), PCa-specific survival (PCSS; 97.4% vs 97.5%; RR: 1.00; 95% CI: 0.93–1.07), biochemical recurrence–free survival (BCRFS; 85.2% vs 85.2%; RR: 1.00; 95% CI: 0.91–1.10), or distant metastasis–free survival (DMFS; 87.1% vs 87.1%; RR: 1.00; 95% CI: 0.92–1.09). Hazard ratios were 0.92 (95% CI: 0.56–1.53) for OS, 1.31 (95% CI: 0.46–3.78) for PCSS, 0.85 (95% CI: 0.56–1.30) for BCRFS, and 0.90 (95% CI: 0.56–1.43) for DMFS. Sample size was a limiting factor. Conclusions and clinical implicationsThere were no differences in survival outcomes between HFRT (68 Gy/25 Fx) and CFRT (76 Gy/38 Fx). HFRT, including PLN radiotherapy and long-term androgen deprivation therapy, should be considered a new standard of care for high-risk PCa patients undergoing external beam radiotherapy.

A comparative review of Aphexda and Mozobil for mobilization prior to stem cell collection.

High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation is the standard of care for eligible patients with newly diagnosed multiple myeloma leading to prolonged progression free and overall survival. Successful engraftment following hematopoietic stem cell infusion requires adequate stem cell doses. Current mobilization regimens include granulocyte colony-stimulating factor (G-CSF) with or without plerixafor. Motixafortide is a recently approved agent that can be used in combination with G-CSF for mobilization. In the absence of any head-to-head trials comparing the two products, this article aims to outline the similarities and differences of these two agents. Though moxitafortide has a more favorable pharmacokinetic profile in comparison to plerixafor, in clinical trials, the agents demonstrated similar efficacy. In addition, the use of motixafortide in clinical practice may be limited by product cost as well as administration and monitoring requirements.