Comparison of mirabegron and vibegron for clinical efficacy and safety in female patients with overactive bladder: a multicenter prospective randomized crossover trial.

PURPOSE: To compare the efficacy and safety of mirabegron and vibegron in female OAB patients. METHODS: We conducted a multicenter, prospective, randomized crossover study of female patients with OAB. The patients were assigned to Group MV (mirabegron for 8 weeks, followed by vibegron for 8 weeks) or group VM (vibegron for 8 weeks, followed by mirabegron for 8 weeks). The primary endpoint was the change in OABSS from baseline, and the secondary endpoint was the change in FVC parameters. After completion of the study, each patient was asked which drug was preferable. RESULTS: A total of 83 patients were enrolled (40 and 43 in groups MV and VM, respectively). At 8th and 16th week, 33 and 29 in Group MV and 34 and 27 in Group VM continued to receive the treatment. The change in PVR was not significantly different between treatment with mirabegron and vibegron. The changes in OABSS, nighttime frequency, mean, and maximum voided volume were similar between mirabegron and vibegron. The mean change in the daytime frequency was greater in the vibegron than in the mirabegron. Of the 56 patients, 15 (27%) and 30 (53%) preferred mirabegron and vibegron, respectively. The remaining 11 patients (20%) showed no preference. The change in the urgency incontinence score during vibegron was better in patients who preferred vibegron to mirabegron. CONCLUSION: The efficacies of mirabegron and vibegron in female patients was similar. The patients' preference for vibegron could depend on the efficacy of vibegron for urgency incontinence.

Radiotherapy is superior to transarterial chemoembolization as adjuvant therapy after narrow-margin hepatectomy in patients with hepatocellular carcinoma: A single-center prospective randomized study.

BACKGROUND: This study was recruited to compare the efficacy and safety of radiotherapy (RT) and transarterial chemoembolization (TACE) as postoperative adjuvant therapy after narrow-margin hepatectomy in hepatocellular carcinoma (HCC) patients. METHODS: This single-center prospective randomized study was conducted in the Cancer Hospital, Guang Xi Medical University, Nanning. A total of 72 patients who received treatment in this hospital between August 2017 and July 2019 were included and randomly allocated to TACE group (n = 48) and RT group (n = 24). Next, overall survival (OS) and progression-free survival (PFS) rates, recurrence patterns, financial burden, and safety were evaluated. RESULTS: The difference between the RT and TACE groups was not significant in one-, three-, and five-year OS (87.5%, 79.0%, and 62.5% vs. 93.8%, 75.9%, and 63.4%, respectively, P = 0.071) and PFS rates (79.0%, 54.2%, and 22.6% vs. 75.0%, 47.9%, and 32.6%, respectively, P = 0.071). Compared to the TACE group, the RT group had significantly lower intrahepatic recurrence rate (20.8% vs. 52.1%, P = 0.011), higher extrahepatic recurrence rate (37.5% vs. 14.6%, P = 0.034), and no marginal and diffuse recurrences (0% vs. 16.7%, P < 0.05). The mean overall treatment cost was higher (¥62,550.59 ± 4397.27 vs. ¥40,732.56 ± 9210.54, P < 0.01), the hospital stay (15.1 ± 3.7 vs. 11.8 ± 4.1 days, P < 0.01) was longer, and the overall treatment stay (13.3 ± 5.3 vs. 41.29 ± 12.4 days, P < 0.01) was shorter in the TACE group than in the RT group. Besides, both groups did not exhibit significant differences in the frequency and severity of adverse events. CONCLUSION: Both adjuvant TACE and RT can better the OS and PFS of patients with HCC. However, RT has a significantly better performance than TACE in terms of improving intrahepatic recurrence rate, treatment cost and hospital stay.

Causal links between sedentary behavior, physical activity, and psychiatric disorders: a Mendelian randomization study.

BACKGROUND: Studies suggest a correlation between excessive sedentary behavior, insufficient physical activity, and an elevated likelihood of experiencing psychiatric disorder. Nonetheless, the precise influence of sedentary behavior and physical activity on psychiatric disorder remains uncertain. Hence, the objective of this research was to investigate the possible causal relationship between sedentary behavior, physical activity, and the susceptibility to psychiatric disorder (depression, schizophrenia and bipolar disorder), utilizing a two-sample Mendelian randomization (MR) approach. METHODS: Potential genetic instruments related to sedentary leisure behaviors were identified from the UK Biobank database, specifically a summary-level genome-wide association study (GWAS) involving 422,218 individuals of European descent. The UK Biobank database also provided the GWAS data for physical activity. Primary analysis was performed using inverse variance weighting (IVW) to assess the causal relationship between sedentary behavior, physical activity, and the risk of psychiatric disorder (depression, schizophrenia and bipolar disorder). Sensitivity analysis was conducted using Cochran's Q test, the MR-Egger intercept test, the MR-pleiotropy RESidual sum and outlier test, leave-one-out analysis, and funnel plot analysis. RESULTS: According to the IVW analysis, there was a significant association between genetically predicted leisure television watching and an increased risk of depression (odds ratio [OR] = 1.027, 95% confidence interval [CI]: 1.001-1.053; P = 0.04). The IVW analysis also indicated that there was a decreased risk of depression associated with fraction accelerations of > 425 milligravities, as measured by accelerometers (OR = 0.951, 95%CI: 0.914-0.989; P = 0.013). The other MR methods obtained consistent but non-significant results in the same direction. However, there was no evidence of a causal association between genetic liability for moderate-to-vigorous physical activity, accelerometer-assessed physical activity, computer use, or driving and the risk of depression. Furthermore, IVW analysis has also found that driving has a slight effect in reducing the risk of schizophrenia (OR = 0.092, 95%CI: 0.010-0.827; P = 0.033), while leisure television viewing has a significant protective effect against the onset of bipolar disorder (OR = 0.719, 95%CI: 0.567-0.912; P = 0.006). CONCLUSION: The study provides compelling evidence of a link between depression, bipolar disorder, and excessive TV watching. Furthermore, it suggests that higher accelerometer-assessed fraction accelerations of > 425 milligravities can serve as a genetic protective factor against depression. To mitigate the risk of developing depression, it is advisable to reduce sedentary activities, particularly television watching, and prioritize engaging in vigorous physical exercise.

Comparable bone penetration between antibiotic-loaded and plain bone cement in total knee arthroplasty.

INTRODUCTION: One of the main concerns around the use of antibiotic-loaded bone cement (ALBC) is the potential reduction in the mechanical properties of the cement when antibiotics are admixed. The purpose of this study was to determine whether there is a difference between plain cement and ALBC in terms of radiological intrusion into the bone in total knee arthroplasties (TKAs). METHODS: Prospective randomized study of 80 consecutive patients who underwent TKA. Depending on the cement used, patients were divided into two groups by a computer-generated randomization programme: the cement without antibiotic (Group 1) or the ALBC (Group 2). Cement intrusion was measured in postoperative radiographs in eight different regions in the tibial component and six regions in the femoral component. RESULTS: The average cement intrusion was similar in both groups (p = nonsignificance [n.s.]). Group 1 (plain cement) had an average cement intrusion in the femur of 1.4 mm (±0.4) and 2.4 mm (±0.4) in the tibia. In Group 2 (ALBC), the average cement intrusion in the femur came to 1.6 (±0.5) and 2.4 mm (±0.5) in the tibia. In 80% of the patients, the cement intrusion in the tibia averaged a minimum of 2 mm, being similar in both groups (p = n.s.). CONCLUSION: There are no differences in bone intrusion when comparing plain cement to ALBC. Therefore, the use of ALBC in primary TKA may be indicated, achieving optimal bone penetration. LEVEL OF EVIDENCE: Level I.

Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design.

INTRODUCTION: Pulmonary vein isolation (PVI) is effective at treating 50% of unselected patients with persistent atrial fibrillation (AF). Alternatively, PVI combined with a new ablation strategy entitled the Marshall-PLAN ensures a 78% 1-year sinus rhythm (SR) maintenance rate in the same population. However, a substantial subset of patients could undergo the Marshall-PLAN unnecessarily. It is therefore essential to identify those patients who can be treated with PVI alone versus those who may truly benefit from the Marshall-PLAN before ablation is performed. In this context, we hypothesized that electrical cardioversion (EC) could help to select the most appropriate strategy for each patient. METHODS: In this multicentre, prospective, randomized study, patients with AF recurrence within 4 weeks after EC will be randomized 1:1 to PVI alone or the Marshall-PLAN. Conversely, patients in whom SR is maintained for ≥4 weeks after EC will be treated with PVI only and included in a prospective registry. The primary endpoint will be the 1-year SR maintenance rate after a single ablation procedure. RESULTS AND CONCLUSION: The Marshall-PLAN might be necessary in patients with an advanced degree of persistent AF (i.e., where SR is not maintained for ≥4 uninterrupted weeks after EC). Conversely, in patients with mild or moderate persistent AF (i.e., where SR is maintained for ≥4 weeks after EC), PVI alone might be a sufficient ablation strategy. The PACIFIC trial is the first study designed to assess whether rhythm monitoring after EC could help to identify patients who should undergo adjunctive ablation strategies beyond PVI.

A randomized phase II study of full dose gemcitabine versus reduced dose gemcitabine and nab-paclitaxel in vulnerable patients with non-resectable pancreatic cancer (DPCG-01).

BACKGROUND: According to current evidence, the best treatment for fit patients with non-resectable pancreatic cancer (PC) is combination chemotherapy, whereas frail patients are recommended gemcitabine (Gem) monotherapy. Randomized controlled trials in colorectal cancer and a post-hoc analysis of gemcitabine and nab-paclitaxel (GemNab) in PC suggest, however, that reduced dose of combination chemotherapy may be feasible and more efficient compared to monotherapy in frail patients. The aim of this study is to investigate whether reduced dose GemNab is superior to full dose Gem in patients with resectable PC, who are not candidates for full dose combination chemotherapy in first line. METHODS: The Danish Pancreas Cancer Group (DPCG)-01 trial is a national multicenter prospective randomized phase II trial. A total of 100 patients in ECOG performance status 0-2 with non-resectable PC, not candidate for full dose combination chemotherapy in first line, but eligible for full dose Gem, will be included. Patients are randomized 1:1 to either full dose Gem or GemNab in 80% of recommended dose. The primary endpoint is progression-free survival. Secondary endpoints are overall survival, overall response rate, quality of life, toxicity and rate of hospitalizations during treatment. The correlation between blood inflammatory markers, including YKL-40 and IL-6, circulating tumor DNA, and tissue biomarkers of resistance to chemotherapy and outcome will be explored. Finally, the study will include measures of frailty (G8, modified G8, and chair-stand-test) to assess whether scoring would enable a personalized allocation to different treatments or indicates a possibility for interventions. DISCUSSION: Single-drug treatment with Gem has for frail patients with non-resectable PC been the main treatment option for more than thirty years, but the impact on outcome is modest. If improved results and sustained tolerability with reduced dose combination chemotherapy can be shown, this could change the future practice for this increasing group of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05841420. Secondary Identifying No: N-20210068. EudraCT No: 2021-005067-52. PROTOCOL VERSION: 1.5, 16-MAY-2023.

Effects on long-term survival of psychosocial group intervention in early-stage breast cancer: follow-up of a randomized controlled trial.

BACKGROUND: The promise of prolonged survival after psychosocial interventions has long been studied, but not convincingly demonstrated. This study aims to investigate whether a psychosocial group intervention improved long-term survival in women with early-stage breast cancer and investigate differences in baseline characteristics and survival between study participants and non-participants. METHODS: A total of 201 patients were randomized to two six-hour psychoeducation sessions and eight weekly sessions of group psychotherapy or care as usual. Additionally, 151 eligible patients declined to participate. Eligible patients were diagnosed and treated at Herlev Hospital, Denmark, and followed for vital status up to 18 years after their primary surgical treatment. Cox's proportional hazard regressions were used to estimate hazard ratios (HRs) for survival. RESULTS: The intervention did not significantly improve survival in the intervention group compared with the control group (HR, 0.68; 95% confidence interval (CI), 0.41-1.14). Participants and non-participants differed significantly in age, cancer stage, adjuvant chemotherapy, and crude survival. When adjusted, no significant survival difference between participants and non-participants remained (HR, 0.77; 95% CI, 0.53-1.11). CONCLUSIONS: We could not show improved long-term survival after the psychosocial intervention. Participants survived longer than nonparticipants, but clinical and demographic characteristics, rather than study participation, seem accountable for this difference.

Twitter promotion is associated with higher citation rates of cardiovascular articles: the ESC Journals Randomized Study.

The association between the dissemination of scientific articles on Twitter and online visibility (as assessed by the Altmetric Score) is still controversial, and the impact on citation rates has never been rigorously addressed for cardiovascular medicine journals using a randomized design. The ESC Journals Study randomized 695 papers published in the ESC Journal Family (March 2018-May 2019) for promotion on Twitter or to a control arm (with no active tweeting from ESC channels) and aimed to assess whether Twitter promotion was associated with an increase in citation rates (primary endpoint) and of the Altmetric Score. This is the final analysis including 694 articles (one paper excluded due to retraction). After a median follow-up of 994 days (interquartile range: 936-1063 days), Twitter promotion of articles was associated with a 1.12 (95% confidence interval: 1.08-1.15) higher rate of citations, and this effect was independent of the type of article. Altmetric Attention Score and number of users tweeting were positive predictors for the number of citations. A social media strategy of Twitter promotion for cardiovascular medicine papers seems to be associated with increased online visibility and higher numbers of citations.

Outcomes of COVID-19 patients undergoing extracorporeal membrane oxygenation: A systematic review and meta-Analysis.

BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic has been ongoing for over 3 years, during which numerous clinical and experimental studies have been conducted. The objective of this systematic review and meta-analysis was to assess the survival probability and complications of COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO). METHODS: We searched the databases by using Population-Intervention-Comparison-Outcome-Study Design (PICOS). We conducted a search of the PubMed, Web of Science, and EMBASE databases to retrieve studies published until December 10, 2022. A random-effects meta-analysis, subgroup analysis, and assessed the studies using the Newcastle-Ottawa Scale score. The results were presented as pooled morbidity with 95% confidence intervals. RESULTS: The study was conducted on 19 studies that enrolled a total of 1494 patients, and the results showed a pooled survival probability of 66.0%. The pooled morbidity for intracranial hemorrhage was 8.7%, intracranial thrombosis 7.0%, pneumothorax 9.0%, pulmonary embolism 11.0%, pulmonary hemorrhage 9.0%, heart failure 14.0%, liver failure 13.0%, renal injury 44.0%, gastrointestinal hemorrhage 6.0%, gastrointestinal ischemia 6.0% and venous thrombosis 31.0%. CONCLUSION: This systematic review and meta-analysis of observational studies focused on the survival probability and complications of COVID-19 patients undergoing ECMO, which are significant in evaluating the use of ECMO in COVID-19 patients and provide a basis for further research. TRIAL REGISTRATION: Our study was registered on PROSPERO with registration number CRD42022382555.

Role of Nebulized Heparin in Clinical Outcome of COVID-19 Patients with Respiratory Symptoms: A Systematic Review.

Coronavirus disease-2019 (COVID-19) is an extremely contagious illness caused by the SARS-CoV-2 virus and has been declared a pandemic by the World Health Organization (WHO). There are currently no particular treatments, however, nebulized heparin has been offered as a viable therapy. The purpose of this systematic review is to assess the efficacy of nebulized heparin in COVID-19 patients with respiratory symptoms. Methods: Relevant studies were identified through a systematic search of the PubMed, Medline, Embase, Cochrane Library and Web of Science, and Scopus databases. The search terms included "nebulized heparin," "COVID-19," and "SARS-CoV-2." Studies that evaluated the use of nebulized heparin in COVID-19 patients with respiratory symptoms were included. The rest of the studies along with those that were not published in English were excluded. The systematic review was registered under PROSPERO-CRD42023413927. Observations: Five studies have been included in this systematic review. Case reports, case series, observational studies, and randomized controlled trial (RCT) comprised the studies. The patient sample sizes ranged from 2 to 98. The studies assessed the efficacy of nebulized heparin in COVID-19 patients with variable disease severity. The evaluated outcomes included mortality, hospital stay duration, oxygen requirements, and laboratory parameters. Conclusion: Based on the clinical studies included in this systematic review, nebulized heparin may be useful in the management of COVID-19. Oxygen saturation was greater, inflammatory indicators were lower, and hospital stays were shorter in these patients. However, the studies had limitations, including inconsistent sample sizes, varying dosages of nebulized heparin, and no control groups. Nebulized heparin in patients with COVID-19 needs to be studied further to determine its safety and effectiveness. How to cite this article: Gupta B, Ahluwalia P, Gupta N, Gupta A. Role of Nebulized Heparin in Clinical Outcome of COVID-19 Patients with Respiratory Symptoms: A Systematic Review. Indian J Crit Care Med 2023;27(8):572-579.

Impact of creative art therapy on fatigue and quality of life in patients treated for localized breast cancer: A randomized study.

BACKGROUND: Art therapy (AT) as supportive care may help patients cope with cancer treatments. This non-blinded randomized trial assessed the impact of creative AT on severe fatigue and quality of life (QoL) in localized breast cancer patients undergoing irradiation. MATERIAL AND METHODS: 320 patients were randomized to an AT group (ATG; 8 weekly sessions starting during irradiation) or to a standard group (SG). The primary endpoint was severe global fatigue (Functional Assessment of Chronic Therapy Fatigue subscale score <37) at 1 month post-irradiation. Quality of life (Fact-B), anxiety/depression (Hospital Anxiety and Depression Scale (HADS)) and different dimensions of fatigue 20-item Multidimensional Fatigue Inventory (MFI-20) were assessed at 1, 6 and 12 months post-irradiation. The secondary endpoints, fatigue among patients treated with chemotherapy, QoL (Fact-B), anxiety/depression (HADS) and different dimensions of fatigue (MFI-20) at 1, 6 and 12 months post-irradiation (with post hoc analysis in patients with treated with chemotherapy) were also assessed. RESULTS: 82% of patients completed ≥8 sessions. Severe initial global fatigue was observed in 43% of patients in each group, and among in 64% of patients whose treatment protocol contained chemotherapy. At 1 month post-irradiation, 45% in the ATG and 57% of patients in the SG reported severe global fatigue (p = 0.37); among patients with initial severe mental fatigue (MFF), 79% and 44% had improved MFF (p = 0.007) respectively; similarly 79% and 44% with initial poor motivation had better mental motivation (p = 0.03). At 6 and 12 months, social well-being scores in the ATG were higher (21.3 and 21.4 vs. 19.8 and 19.2, p = 0.05 and p < 0.01) with a significant improvement for patients who had chemotherapy (41% vs. 18%, p = 0.017). A positive association was observed between the number of AT sessions, fatigue and QoL (p < 0.01). CONCLUSION: AT did not significantly improve global severe fatigue among all cancer participants 1 month after radiation therapy, however it had a positive impact on social well-being and may improve MFF and motivation.

Individualized or fixed approach to pulmonary vein isolation utilizing the fourth-generation cryoballoon in patients with paroxysmal atrial fibrillation: the randomized INDI-FREEZE trial.

AIMS: Cryoballoon (CB) based pulmonary vein isolation (PVI) is a widely used technique for treatment of atrial fibrillation (AF); however the ideal energy dosing has not yet been standardized. This was a single-centre randomized clinical trial aiming at assessing the safety, acute efficacy, and clinical outcome of an individualized vs. a fixed CB ablation protocol using the fourth-generation CB (CB4) guided by pulmonary vein (PV) potential recordings and CB temperature. METHODS AND RESULTS: Patients were randomized in a 1:1 fashion to two different dosing protocols: INDI-FREEZE group (individualized protocol): freeze-cycle duration of time to effect plus 90 s or interruption of the freeze-cycle and repositioning CB if a CB temperature of -30°C was not within 40 s. Control group (fixed protocol): freeze-cycle duration of 180 s. No-bonus freeze-cycle was applied in either patient group. The primary endpoint was freedom from atrial tachyarrhythmia at 12 months. Secondary end points included procedural parameters and complications. A total of 100 patients with paroxysmal AF were prospectively enrolled. No difference was seen in the primary endpoint [INDI-FREEZE group: 38/47 (81%) vs. control group: 40/47, (85%), P = 0.583]. The total freezing time was significantly shorter in the INDI-FREEZE group (157 ± 56 s vs. 212 ± 83 s, P < 0.001), while procedure duration (57.9 ± 17.9 min vs. 63.2 ± 20.2 min, P = 0.172) was similar. No differences were seen in the minimum CB and oesophageal temperatures as well as in periprocedural complications. CONCLUSION: Compared to the fixed protocol, the individualized approach provides a similar safety profile and clinical outcome, while reducing the total freezing time.

Carbon dioxide rises beyond acceptable safety levels in children under nose and mouth covering: Results of an experimental measurement study in healthy children.

Nose and mouth covering (NMC) has been made compulsory for children in many countries during the Covid-19 pandemic. We wanted to determine the average CO2 levels in inhaled air with NMC in children between age 6 and 17. We used short term measurements under surgical masks and FFP2 masks according to European norm EN 149, compared to baseline in an experimental, intra-individually controlled study over 25 min. CO2 content was measured every 15 s using an automated dual-wavelength infrared CO2 measurement device (G100, Geotech, Leamington Spa, UK) over 25 min in a short-term experimental setting, with children seated. After baseline measurement children were provided with two types of commonly worn NMC: surgical masks and FFP2--masks in randomized sequence for 3 min each. We kept ambient CO2-levels below 1000 parts per million (ppm) through frequent ventilation. We measured breathing frequency and pulse as potential physiological moderator variables. Forty-five children, 25 boys, 20 girls, with a mean age of 10.7 years (standard deviation 2.6) were measured. We measured 13,100 ppm (SD 380) under surgical mask and 13,900 ppm (SD 370) under FFP2 mask in inhaled air. A linear model with age as a covariate showed a highly significant effect of the condition (p < 1*10-9). We measured 2,700 ppm (SD 100) CO2 at pre-baseline and 2,800 ppm (SD 100) at post-baseline, a non-significant small difference. Appropriate contrasts revealed that the change was due to the masks only and the difference between the two types of masks was small and not significant. Wearing of NMC (surgical masks or FFP2- -masks) raises CO2 content in inhaled air quickly to a very high level in healthy children in a seated resting position that might be hazardous to children's health.

The causal relationship between sleep traits and the risk of schizophrenia: a two-sample bidirectional Mendelian randomization study.

BACKGROUND: Observational studies suggest that sleep disturbances are commonly associated with schizophrenia. However, it is uncertain whether this relationship is causal. To investigate the bidirectional causal relation between sleep traits and schizophrenia, we performed a two-sample bidirectional Mendelian randomization (MR) study with the fixed effects inverse-variance weighted (IVW) method. METHODS: As genetic variants for sleep traits, we selected variants from each meta-analysis of genome-wide association studies (GWASs) conducted using data from the UK Biobank (UKB). RESULTS: We found that morning diurnal preference was associated with a lower risk of schizophrenia, while long sleep duration and daytime napping were associated with a higher risk of schizophrenia. Multivariable MR analysis also showed that sleep duration was associated with a higher risk of schizophrenia after adjusting for other sleep traits. Furthermore, genetically predicted schizophrenia was negatively associated with morning diurnal preference and short sleep duration and was positively associated with daytime napping and long sleep duration. CONCLUSIONS: Therefore, sleep traits were identified as a potential treatment target for patients with schizophrenia.

Examining the impact perceptual learning artificial-intelligence-based on the incidence of paresthesia when performing the ultrasound-guided popliteal sciatic block: simulation-based randomized study.

OBJECTIVE: To explore the impact of artificial-intelligence perceptual learning when performing the ultrasound-guided popliteal sciatic block. METHODS: This simulation-based randomized study enrolled residents who underwent ultrasound-guided sciatic nerve block training at the Department of Anesthesiology of Beijing Jishuitan Hospital between January 2022 and February 2022. Residents were randomly divided into a traditional teaching group and an AI teaching group. All residents attended the same nerve block theory courses, while those in the AI teaching group participated in training course using an AI-assisted nerve identification system based on a convolutional neural network instead of traditional training. RESULTS: A total of 40 residents were included. The complication rates of paresthesia during puncture in the first month of clinical sciatic nerve block practice after training were significantly lower in the AI teaching group than in the traditional teaching group [11 (4.12%) vs. 36 (14.06%), P = 0.000093]. The rates of paresthesia/pain during injection were significantly lower in the AI teaching group than in the traditional teaching group [6 (2.25%) vs. 17 (6.64%), P = 0.025]. The Assessment Checklist for Ultrasound-Guided Regional Anesthesia (32 ± 3.8 vs. 29.4 ± 3.9, P = 0.001) and nerve block self-rating scores (7.53 ± 1.62 vs. 6.49 ± 1.85, P < 0.001) were significantly higher in the AI teaching group than in the traditional teaching group. There were no significant differences in the remaining indicators. CONCLUSION: The inclusion of an AI-assisted nerve identification system based on convolutional neural network as part of the training program for ultrasound-guided sciatic nerve block via the popliteal approach may reduce the incidence of nerve paresthesia and this might be related to improved perceptual learning. CLINICAL TRIAL: CHiCTR2200055115 , registered on 1/ January /2022.

No difference in clinical outcome at 2-year follow-up in patients with type III and V acromioclavicular joint dislocation treated with hook plate or physiotherapy: a randomized controlled trial.

BACKGROUND: The need for operative treatment of acute acromioclavicular (AC) joint dislocation is unclear. The purpose of this randomized controlled trial was to compare the outcomes after operative treatment with a hook plate with the outcomes after nonoperative treatment of acute Rockwood type III and type V AC joint dislocations separately. METHODS: The inclusion criteria were patients aged 18-65 years with an acute type III or type V AC joint dislocation with the availability to start treatment within 3 weeks after trauma. All patients received the same standardized outpatient rehabilitation protocol and were followed up for 24 months. Assessments were based on radiographs, clinical examination findings, and questionnaires. The primary outcome was the Constant score (CS). The secondary outcomes were as follows: Subjective Shoulder Value (SSV), QuickDASH score (abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire), shoulder pain at rest and during movement rated using a visual analog scale, EQ-5D (European Quality of Life 5 Dimensions) score, patient satisfaction, cosmesis, complications, and adverse events. The 4 groups were compared using 1-way analysis of variance and intention to treat. RESULTS: The included patients (N = 124) (mean age, 40 years [range, 18-64 years]; 91% male patients) were randomized, stratified by type, to nonoperative treatment (type III, n = 33; type V, n = 30) or operative treatment with a hook plate (type III, n = 30; type V, n = 31) at a single center. Three patients randomized to physiotherapy dropped out before any follow-up measures, leaving 121 patients in the study. Complete clinical follow-up data were obtained from 118 patients at 24 months. At 3 months, patients in both nonoperatively treated groups had a significantly better mean CS, SSV, and QuickDASH score and had less pain at rest and during movement compared with patients treated operatively. At 6, 12, and 24 months, there were no significant differences in the CS, SSV, QuickDASH score, pain, or EQ-5D score between the groups regardless of intervention. At 24 months, the mean CS was 88 for nonoperatively treated type III patients vs. 91 for operatively treated type III patients and was 90 vs. 91 for type V patients (P = .477). At final follow-up, patients had regained 97% of the mean CS comparing the uninjured and injured shoulders and 86% of the patients rated the result as excellent or good. Eleven patients assigned to nonoperative treatment (18%, 6 type III and 5 type V) underwent surgery within 19 months. CONCLUSIONS: Both the nonoperative and operative treatment groups had very good restoration of shoulder function and patient satisfaction at 24 months, and operative treatment did not lead to better outcomes compared with nonoperative treatment. In conclusion, our study does not support surgery with a hook plate in patients with acute Rockwood type III or type V AC joint dislocations.

A Randomized Study to Assess the Effect of Including the Graduate Record Examinations Results on Reviewer Scores for Underrepresented Minorities.

Whether requiring Graduate Record Examinations (GRE) results for doctoral applicants affects the diversity of admitted cohorts remains uncertain. This study randomized applications to 2 population-health doctoral programs at the University of California San Francisco to assess whether masking reviewers to applicant GRE results differentially affects reviewers' scores for underrepresented minority (URM) applicants from 2018-2020. Applications with GRE results and those without were randomly assigned to reviewers to designate scores for each copy (1-10, 1 being best). URM was defined as self-identification as African American/Black, Filipino, Hmong, Vietnamese, Hispanic/Latinx, Native American/Alaska Native, or Native Hawaiian/Other Pacific Islander. We used linear mixed models with random effects for the applicant and fixed effects for each reviewer to evaluate the effect of masking the GRE results on the overall application score and whether this effect differed by URM status. Reviewer scores did not significantly differ for unmasked versus masked applications among non-URM applicants (ß = 0.15; 95% CI: -0.03, 0.33) or URM applicants (ß = 0.02, 95% CI: -0.49, 0.54). We did not find evidence that removing GREs differentially affected URM compared with non-URM students (ß for interaction = -0.13, 95% CI: -0.55, 0.29). Within these doctoral programs, results indicate that GRE scores neither harm nor help URM applicants.

External validation of two MRI-based risk calculators in prostate cancer diagnosis.

BACKGROUND: The diagnosis of (significant) prostate cancer ((s)PC) is impeded by overdiagnosis and unnecessary biopsy. Risk calculators (RC) have been developed to mitigate these issues. Contemporary RCs integrate clinical characteristics with mpMRI findings. OBJECTIVE: To validate two of these models-the MRI-ERSPC-RC-3/4 and the risk model of van Leeuwen. METHODS: 265 men with clinical suspicion of PC were enrolled. Every patient received a prebiopsy mpMRI, which was reported according to PI-RADS v2.1, followed by MRI/TRUS fusion-biopsy. Cancers with ISUP grade ≥ 2 were classified as sPC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Statistical analysis was performed by comparing discrimination, calibration, and clinical utility RESULTS: There was no significant difference in discrimination between the RCs. The MRI-ERSPC-RC-3/4-RC showed a nearly ideal calibration-slope (0.94; 95% CI 0.68-1.20) than the van Leeuwen model (0.70; 95% CI 0.52-0.88). Within a threshold range up to 9% for a sPC, the MRI-ERSPC-RC-3/4-RC shows a greater net benefit than the van Leeuwen model. From 10 to 15%, the van Leeuwen model showed a higher net benefit compared to the MRI-ERSP-3/4-RC. For a risk threshold of 15%, the van Leeuwen model would avoid 24% vs. 14% compared to the MRI-ERSPC-RC-3/4 model; 6% vs. 5% sPC would be overlooked, respectively. CONCLUSION: Both risk models supply accurate results and reduce the number of biopsies and basically no sPC were overlooked. The van Leeuwen model suggests a better balance between unnecessary biopsies and overlooked sPC at thresholds range of 10-15%. The MRI-ERSPC-RC-3/4 risk model provides better overall calibration.

Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation.

AIMS: Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). METHODS AND RESULTS: A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001). CONCLUSIONS: Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.

First-line pembrolizumab with or without platinum doublet chemotherapy in non-small-cell lung cancer patients with PD-L1 expression ≥50.

Pembrolizumab plus chemotherapy is currently used in the first-line treatment of advanced non-small-cell lung cancer without EGFR mutations or ALK rearrangements, regardless of PD-L1 expression status. A study comparing chemotherapy plus pembrolizumab versus pembrolizumab alone has never been performed in patients with PD-L1 ≥50%. The aim of this trial is to perform such a comparison as first-line treatment in patients not eligible for locally advanced treatment who have expression of PD-L1 on ≥50% of tumor cells. The expected results are a reduction in the risk of early progression. A higher objective tumor response is also expected with the combination of chemotherapy and pembrolizumab compared with pembrolizumab alone. The study will allow a direct comparison of the proportion of patients who derive long-term benefit from the treatment. Clinical trial number: EudraCT (2020-002626-86); ClinicalTrials.gov (NCT04547504).

Lay abstract Non-small-cell lung cancer (NSCLC) is the most frequent type of lung cancer. Most NSCLC patients are diagnosed with advanced disease and only 10­15% of them are alive after 5 years. In the absence of specific tumor mutations, the currently recommended treatment is a combination of chemotherapy and immunotherapy with the monoclonal antibody pembrolizumab. The goal of immunotherapy is to prevent cancer from evading the immune system by interacting with molecules expressed at the surface of tumor cells (PD-L1) or immune cells (PD-1). A study comparing chemotherapy plus pembrolizumab versus pembrolizumab alone has never been performed in patients with a high level of PD-L1 expression on tumor cells. Therefore we designed the PERSEE study to compare these treatments in advanced-stage NSCLC patients with PD-L1 expression on ≥50% of tumor cells.