Clinical Superiority Research Articles

Cervical Laminoplasty is Associated With Lower Health Care Costs as Compared With Cervical Fusion Procedures: A Systematic Review and Meta-analysis of Comparative Studies.

Systematic review and meta-analysis. The purpose of this study is to examine the cost of CLP versus CF stratified by approach to guide decision-making. Cervical laminoplasty (CLP) and cervical fusion (CF) are viable alternatives for surgical management of cervical spine myelopathy, with no clear consensus on clinical superiority. However, despite clinical equivalence in patient outcomes, there is limited data on the relative costs between CLP and CF. This study searched PubMed, CINAHL, MEDLINE, and Web of Science databases. Inclusion criteria were articles that examined the cost between CLP and any type of CF (stratified by anterior, posterior, or combined approach). A random-effects continuous model for meta-analysis was performed using standardized mean difference (SMD). Eleven articles were included. Patients (n = 21,033) had an average age of 56.0 ± 3.6 years and underwent either CLP (n = 4364), posterior CF (n = 3529), anterior CF (n = 13,084), or combined CF (n = 56). The mean reported cost among patients who underwent CLP (n=3742) was significantly lower compared with patients who underwent CF (n = 6329), irrespective of the approach for CF (P = 0.028; SMD = -2.965). For subgroup analysis by surgical approach, the mean reported cost among patients treated with CLP was significantly lower as compared with patients treated with posterior CF (P = 0.013; SMD = -1.861) and anterior CF (P < 0.001; SMD = -0.344). Patients who underwent CLP had a significantly lower mean hardware cost than patients who underwent posterior CF (P < 0.001; SMD = -3.275). CLP appears to be associated with statistically significant and clinically relevant lower reported costs than CF, irrespective of the approach based on meta-analysis of low or moderate-quality retrospective studies. CLP may also have lower reported costs than both posterior CF and anterior CF. IV.

Radiomics nomogram combined with clinical factors for predicting pathological complete response in resectable esophageal squamous cell carcinoma

IntroductionPredicting the efficacy of neoadjuvant immunochemotherapy (NICT) for esophageal squamous cell carcinoma (ESSC) prior to surgery can minimize unnecessary surgical interventions and facilitate personalized treatment strategies. Our goal is to develop and validate an image-based radiomic model using preoperative computed tomography (CT) scans and clinical data to predict pathological complete response (pCR) in resectable ESSC following neoadjuvant immunotherapy.MethodsWe retrospectively collected data from patients diagnosed with ESCC at the First Affiliated Hospital of Soochow University between January 2018 and May 2023, who received preoperative neoadjuvant immunochemotherapy. Eligible patients were randomly divided into training and validation sets. Radiomic features extracted from preprocessed CT images were used to develop a radiomic model, incorporating Radiomic score (Rad-score) and clinical factors through multivariate logistic regression analysis. The model’s performance was assessed for calibration, discrimination, and clinical utility in an independent validation cohort.ResultsWe enrolled a total of 105 eligible participants who were randomly divided into two groups: a training set (N=74) and a validation set (N=31). After data dimension reduction and feature selection, we identified 11 radiomic features, which collectively formed the Rad-score. Rad-score had an area under the curve (AUC) of 0.83 (95% CI 0.72-0.93) in the training set and 0.78 (95% CI 0.60-0.95) in the validation set. Multivariate analysis revealed that radiological response and Neutrophil–Lymphocyte Ratio (NLR) were independent predictors of pCR, with p-values of 0.0026 and 0.0414, respectively. We developed and validated a nomogram combining Rad-score and clinical features, achieving AUCs of 0.90 (95% CI 0.82-0.98) in the training set and 0.85 (95% CI 0.70-0.99) in the validation set. The Delong test confirmed the nomogram’s superiority over pure radiomic and clinical models. Decision curve analysis (DCA) and integrated discrimination improvement (IDI) assessment supported the clinical value and superiority of the combined model.ConclusionThe nomogram, which integrates Rad-score and clinical features, offers a precise and reliable method for predicting pCR status in ESCC patients who have undergone neoadjuvant immunochemotherapy. This tool aids in tailoring treatment strategies to individual patients.

Carpal tunnel release under local anesthesia with or without distal median nerve block: Double-blind randomized clinical trial

Background: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, and its surgical treatment is carpal tunnel release (CTR). It is mostly performed in local anesthesia. There are no clinical randomized controlled trials (RCTs) comparing local infiltration anesthesia with or without a distal median nerve block in CTR. The aim of the PERSONNEL trial (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is to assess whether a distal median nerve block reduces pain during and after the procedure in addition to local anesthesia. Methods: This is a single-center randomized clinical superiority trial comparing local anesthesia alone and local anesthesia with a distal median nerve block for CTR in patients with CTS. Adult patients will be randomized in one university hospital in Finland, and the intended sample size is 118. The primary outcome is the mean pain level after the procedure during 72 h using a visual analogue scale (VAS). The secondary outcomes include expected pain; pain during the injection of the anesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anesthesia; number of experienced needle stings; Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ); pain killer consumption;, patient satisfaction using Net Promoter Score (NPS); and complications. Discussion: Patient satisfaction is a crucial factor in modern healthcare. A distal median nerve block may reduce pain during and after CTR, potentially increasing patient satisfaction with the given treatment. It can also be hypothesized that better postoperative pain control may prevent complications, for example, complex regional pain syndrome. However, we lack adequate evidence to justify the use of distal median nerve block, which can itself predispose patients to complications, for example, median nerve injury. Therefore, there is a need for adequate RCTs to assess its efficacy. The results of this study can be used to optimize anesthesia for carpal tunnel surgery, improve patient satisfaction, and possibly prevent complications. Registration: ClinicalTrials.gov NCT05372393.

Measures of Performance and Clinical Superiority Thresholds for 'Test-and-treat' Predictive Biomarkers.

Predictive biomarkers are intended to predict an individual's expected response to specific treatments. These are an important component of precision medicine. We explore measures of biomarker performance that are based on the expected probability of response to individual treatment conditional on biomarker status. We show how these measures can be used to establish thresholds at which testing strategies will be clinically superior. We used a decision model to compare expected probabilities of response of treat-all and test-and-treat strategies. Based on this, R-Shiny-based apps were developed which produce plots of the threshold positive and negative predictive values or sensitivities and specificities above which a 'test-and-treat' strategy will outperform a 'treat-all' strategy. We present a case study using data on the use of RAS status to predict response to panitumumab in metastatic colorectal cancer. Where a companion diagnostic is predictive of response to one of the treatments being compared, it is possible to estimate threshold sensitivities and specificities above which a testing strategy will outperform a treat-all strategy, based only on the odds ratio of response. Where negative and positive predictive values were used, the threshold depended on the prevalence of the biomarker-positive patients. These intuitive performance measures for predictive biomarkers, based on expected response to individual treatments, can be used to identify promising candidate companion diagnostic tests and indicate the potential magnitude of the net benefit of testing.

Effect of tailoring biliopancreatic limb length based on total small bowel length versus standard limb length in one anastomosis gastric bypass: 1-year outcomes of the TAILOR randomized clinical superiority trial.

Tailoring the biliopancreatic limb length in one anastomosis gastric bypass is proposed as beneficial in retrospective studies, yet randomized trials are lacking. The aim of this double-blind, single-centre RCT was to ascertain whether tailoring biliopancreatic limb length based on total small bowel length (TSBL) results in superior outcomes after one anastomosis gastric bypass compared with a fixed 150 cm biliopancreatic limb length. Eligible patients, meeting International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) criteria for metabolic bariatric surgery, scheduled for primary one anastomosis gastric bypass surgery, and willing to be randomized, underwent TSBL measurement during surgery. When TSBL measurement was feasible, patients were randomly assigned to a standard 150 cm biliopancreatic limb length or a tailored biliopancreatic limb based on TSBL: TSBL less than 500 cm, biliopancreatic limb 150 cm; TSBL 500-700 cm, biliopancreatic limb 180 cm; and TSBL greater than 700 cm, biliopancreatic limb 210 cm. The primary outcome was percentage total weight loss at 5 years. Between September 2020 and August 2022, 212 patients were randomized into the standard biliopancreatic limb group (105 patients) or the tailored biliopancreatic limb group (107 patients). The mean(s.d.) TSBL was 657(128) cm (range 295-1020 cm). In the tailored group, 150, 180, and 210 cm biliopancreatic limb lengths were applied to 8.4%, 53.3%, and 38.3% of patients respectively. The mean(s.d.) 1-year percentage total weight loss was 32.8(6.9)% in the standard group and 33.1(6.2)% in the tailored group (P = 0.787). Nutritional deficiencies and short-term complications showed no significant differences. Tailoring biliopancreatic limb length based on TSBL is safe and feasible. One year after surgery, it is not superior to a standard biliopancreatic limb length of 150 cm in terms of percentage total weight loss. Dutch Trial Register, NL7945.

Clinical Diagnosis Superiority in Appendicitis Cases: An Integrative Analysis with Ultrasound Findings and Complete Hemogram

Aim: This study aims to evaluate the diagnostic effectiveness of clinical diagnosis compared to ultrasound findings and elevated total count in identifying acute appendicitis.  Methods: A cross-sectional study was conducted over three months with 30 patients aged 10-60 years presenting to the General Surgery OPD/ER. The patients were evaluated using clinical diagnosis, ultrasound, and complete hemogram. Clinical findings included McBurney’s tenderness, Blumberg sign, and lateral wall tenderness on Digital Rectal Examination. Data on ultrasound findings and total leukocyte count were collected and analyzed.  Results: Clinical diagnosis accurately identified acute appendicitis in all 30 cases. Ultrasound confirmed appendicitis in 18 cases (60%), while elevated total leukocyte count was observed in 20 cases (66.6%). When combining clinical evaluation, ultrasound, and hemogram data, a comprehensive diagnosis was achieved in 13 cases (43.4%).  Conclusion: Clinical diagnosis remains the superior method for identifying acute appendicitis. Ultrasound and hemogram serve as valuable adjuncts, refining diagnostic accuracy. The integrative approach ensures optimal patient management. This study advocates for the continued development of clinical expertise alongside auxiliary

P-162 Embryo transfer impact: a comprehensive national cohort analysis comparing maternal outcomes across varied embryo stages in fresh and frozen transfers

Abstract Study question What is the ideal choice between fresh and frozen embryos transfer, and should the transfer be done at the cleavage or blastocyst stage? Summary answer This study highlights the clinical pregnancy and live birth superiority of frozen embryo transfer in blastocysts but not in cleavage stage embryos. What is known already Frozen embryo transfer not only improves reproductive outcomes by increasing the chances of live birth and clinical pregnancy but also enhances safety by reducing the risks of OHSS and multiple pregnancies. Due to the consistent findings, there has been a growing discussion in recent years about whether it is advisable to adopt elective frozen embryo transfer as the standard practice. Study design, size, duration In this retrospective cohort study conducted in Taiwan, a comprehensive dataset from the national assisted reproductive technology (ART) database was utilized, covering the period from January 1st, 2013, to December 31st, 2017. The final cohort study encompassed eligible 51762 female participants who had undergone ART and embryo transfer. Pregnancy outcomes and maternal complications during the follow-up were assessed using the population registry dataset from January 1st, 2013, to December 31st, 2018. Participants/materials, setting, methods The study categorizes cases into groups based on whether they underwent fresh or frozen embryo transfers, with additional subgroups based on cleavage stage and blastocyst stage transfers. Exposure variables include clinical pregnancy rate, live birth rate, ovarian hyperstimulation syndrome (OHSS), pregnancy-induced hypertension, gestational diabetes mellitus (DM), placenta previa, placental abruption, and preterm premature rupture of membranes (PPROM). Main results and the role of chance For pregnancy outcomes, frozen blastocyst transfers exhibited higher rates of clinical pregnancy (OR 1.33, 95%CI 1.25-1.42) and live births (OR 1.27, 95%CI 1.19-1.36) when compared to fresh blastocyst transfers. However, frozen cleavage stage transfers had lower rates of clinical pregnancy (OR 0.73, 95%CI 0.69-0.77) and live births (OR 0.79, 95%CI 0.74-0.84) compared to fresh cleavage stage transfers. For maternal complications, frozen embryo transfers were associated with reduced risks of OHSS (OR 0.02, 95%CI 0.02-0.03 for blastocyst and OR 0.05, 95%CI 0.03-0.09 for cleavage stage) compared to fresh embryo transfers, but were linked to a higher risk of pregnancy-induced hypertension (OR 1.43, 95%CI 1.19-1.73 for blastocyst and OR 1.23, 95%CI 1.29-1.82 for cleavage stage). No significant differences were observed in the incidence of gestational DM and PPROM among the various transfer groups. Limitations, reasons for caution Our retrospective study design may not offer the same level of rigor as a randomized controlled trial. Furthermore, the reproductive database did not provide detailed information on specific endometrial preparation methods (such as hormone replacement therapy or natural cycle), which could potentially influence implantation outcomes. Wider implications of the findings The freeze-all strategy may not be suitable for universal application. When embryos can develop to the blastocyst stage, frozen embryo transfer is a favorable choice, but embryos can only develop to the cleavage stage, fresh embryo transfer becomes a more reasonable option. Trial registration number KMUHIRB-E(I)-20210222

POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II—study protocol of a randomized clinical trial

BackgroundOne single-center randomized clinical trial showed that INTELLiVENT-adaptive support ventilation (ASV) is superior to conventional ventilation with respect to the quality of ventilation in post-cardiac surgery patients. Other studies showed that this automated ventilation mode reduces the number of manual interventions at the ventilator in various types of critically ill patients. In this multicenter study in patients post-cardiac surgery, we test the hypothesis that INTELLiVENT-ASV is superior to conventional ventilation with respect to the quality of ventilation.Methods“POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II)” is an international, multicenter, two-group randomized clinical superiority trial. In total, 328 cardiac surgery patients will be randomized. Investigators screen patients aged > 18 years of age, scheduled for elective cardiac surgery, and expected to receive postoperative ventilation in the ICU for longer than 2 h. Patients either receive automated ventilation by means of INTELLiVENT-ASV or ventilation that is not automated by means of a conventional ventilation mode. The primary endpoint is quality of ventilation, defined as the proportion of postoperative ventilation time characterized by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first two postoperative hours. One major secondary endpoint is ICU team staff workload, captured by the ventilator software collecting manual settings on alarms. Patient-centered endpoints include duration of postoperative ventilation and length of stay in ICU.DiscussionPOSITiVE II is the first international, multicenter, randomized clinical trial designed to confirm that POStoperative INTELLiVENT-ASV is superior to non-automated conventional ventilation and secondary to determine if this closed-loop ventilation mode reduces ICU team staff workload. The results of POSITiVE II will support intensive care teams in their choices regarding the use of automated ventilation in postoperative care of uncomplicated cardiac surgery patients.Trial registrationClinicaltrials.gov NCT06178510. Registered on December 4, 2023.

Video mirror feedback induces more extensive brain activation compared to the mirror box: an fNIRS study in healthy adults

BackgroundMirror therapy (MT) has been shown to be effective for motor recovery of the upper limb after a stroke. The cerebral mechanisms of mirror therapy involve the precuneus, premotor cortex and primary motor cortex. Activation of the precuneus could be a marker of this effectiveness. MT has some limitations and video therapy (VT) tools are being developed to optimise MT. While the clinical superiority of these new tools remains to be demonstrated, comparing the cerebral mechanisms of these different modalities will provide a better understanding of the related neuroplasticity mechanisms.MethodsThirty-three right-handed healthy individuals were included in this study. Participants were equipped with a near-infrared spectroscopy headset covering the precuneus, the premotor cortex and the primary motor cortex of each hemisphere. Each participant performed 3 tasks: a MT task (right hand movement and left visual feedback), a VT task (left visual feedback only) and a control task (right hand movement only). Perception of illusion was rated for MT and VT by asking participants to rate the intensity using a visual analogue scale. The aim of this study was to compare brain activation during MT and VT. We also evaluated the correlation between the precuneus activation and the illusion quality of the visual mirrored feedback.ResultsWe found a greater activation of the precuneus contralateral to the visual feedback during VT than during MT. We also showed that activation of primary motor cortex and premotor cortex contralateral to visual feedback was more extensive in VT than in MT. Illusion perception was not correlated with precuneus activation.ConclusionVT led to greater activation of a parieto-frontal network than MT. This could result from a greater focus on visual feedback and a reduction in interhemispheric inhibition in VT because of the absence of an associated motor task. These results suggest that VT could promote neuroplasticity mechanisms in people with brain lesions more efficiently than MT.Clinical trial registrationNCT04738851.

Effects of Preoperative Intravenous Versus Subcutaneous Tranexamic Acid on Postoperative Periorbital Ecchymosis and Edema Following Upper Eyelid Blepharoplasty: A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Comparative Study.

To compare the effects of preoperative tranexamic acid (TXA) administered intravenously (IV) versus subcutaneously on postoperative ecchymosis and edema in patients undergoing bilateral upper eyelid blepharoplasty. A prospective, double-blinded, placebo-controlled study of patients undergoing bilateral upper eyelid blepharoplasty at a single-center. Eligible participants were randomized to preoperatively receive either (1) 1 g of TXA in 100 ml normal saline IV, (2) 50 µl/ml of TXA in local anesthesia, or (3) no TXA. Primary outcomes included ecchymosis and edema at postoperative day 1 (POD1) and 7 (POD7). Secondary outcomes included operative time, pain, time until resuming activities of daily living, patient satisfaction, and adverse events. By comparison (IV TXA vs. local subcutaneous TXA vs. no TXA), ecchymosis scores were significantly lower on POD1 (1.31 vs. 1.56 vs. 2.09, p = 0.02) and on POD7 (0.51 vs. 0.66 vs. 0.98, p = 0.04) among those that received TXA. By comparison (IV TXA vs. local subcutaneous TXA vs. no TXA), significant reductions in edema scores occurred in those that received TXA on POD1 (1.59 vs. 1.43 vs. 1.91, p = 0.005) and on POD7 (0.85 vs. 0.60 vs. 0.99, p = 0.04). By comparison (IV TXA vs. local subcutaneous TXA vs. no TXA) patients treated with intravenous and local subcutaneous TXA preoperatively were more likely to experience shorter operative times (10.8 vs. 11.8 vs. 12.9 minutes, p = 0.01), reduced time to resuming activities of daily livings (1.6 vs. 1.6 vs. 2.3 days, p < 0.0001), and higher satisfaction scores at POD1 (8.8 vs. 8.7 vs. 7.9, p = 0.0002). No adverse events occurred were reported. In an analysis of 106 patients, preoperative TXA administered either IV or subcutaneously safely reduced postoperative ecchymosis and edema in patients undergoing upper eyelid blepharoplasty. While statistical superiority between intravenous versus local subcutaneous TXA treatment was not definitively identified, our results suggest clinical superiority with IV dosing.

The Practice of Prolonging Meropenem Infusion: A Narrative Review of Literatures Over the Last Decade

Background: The emergence of Antimicrobial Resistance (AMR) has forced clinicians and medical professionals to implement a strict Antimicrobial Stewardship policy. One of the pillar of Antimicrobial Stewardship is by optimizing the use of antibiotic agents. Beta-lactams demonstrate a time-dependent effect in combating bacteria. Since it is pharmacodynamically supported, a prolonged exposure via intravenous administration could be a feasible strategy to maximize the bactericidal effect. Meropenem, a beta-lactam antibiotic of carbapenems sub-class, also falls into the category above. However, there are questions to be answered regarding its stability, compatibility, safety, and clinical outcomes superiority compared to the standard intermittent infusion, before we can determine its effectiveness to be delivered as prolonged or extended infusion. Aims: This article would like to review literatures regarding the rationale behind the practice of prolonging meropenem infusion from the last decade. Method: For this narrative review we utilized articles extracted from Cochrane Library, ScienceDirect, and SageJournals databases from the last ten years. We also added complementary related articles from UpToDate®. Selected articles were limited to those published in english. Inclusion criteria specifically only including related articles to the practice of prolonging meropenem infusion on adult patients. A total of 18 articles were reviewed for the synthesis of this narrative review. Conclusion: Meropenem is eligible for prolonged infusion protocol since it is theoretically supported, adequate in stability, less concern for incompatibility, and potentially can provide better clinical outcomes compared to standard intermittent infusion.

Comparative Study on the Efficacy of Pregabalin Versus Limaprost in Patients With Lumbar Spinal Stenosis: A Prospective, Randomized Controlled Trial

BackgroundPatients with Lumbar Spinal Stenosis (LSS) typically complain of back pain and leg pain. These symptoms reduce the quality of life and also cause sleep disturbances. This study compares pregabalin and limaprost's efficacy in LSS for pain, disability, quality of life, and sleep, aiming to offer insights for medication selection. MethodsThis study was designed as a prospective, randomized, single-center, single-blinded, clinical superiority trial targeting patients with LSS. For 6 weeks, 111 patients per group were administered medication following a standard regimen, after which patient-reported outcomes were measured. The primary outcome was the Visual Analogue Scale (VAS) for back and leg pain, and the secondary outcomes included the Oswestry Disability Index (ODI), European Quality of Life 5 Dimensions (EQ-5D), and sleep quality. ResultsAfter 6 weeks of medication, there were significant improvements over time in the primary outcome, VAS for back pain and leg pain, in both groups, but no significant difference between the two groups. Similarly, for the secondary outcomes, ODI and EQ-5D, both groups showed significant improvements, yet there was no significant difference between them. In the subgroup analysis targeting poor sleepers (Pittsburgh sleep quality index, PSQI > 5), both groups also exhibited significant improvements in sleep quality, but again, there was no significant difference between the groups. ConclusionsEfficacy of pregabalin, limaprost in back and leg pain, ODI, EQ-5D, and sleep quality, but there was no significant difference between the two groups. Thus, it is advisable to prescribe based on individual drug responses and potential complications.

Noninvasive Monitoring of Early Cardiac Fibrosis in Diabetic Mice by [68Ga]Ga-DOTA-FAPI-04 PET/CT Imaging.

Cardiac fibrosis represents one of the representative pathological characteristics in the diabetic heart. Active fibroblasts play an essential role in the progression of cardiac fibrosis. The technologies for noninvasive monitoring of activated fibroblasts still have to be investigated. The purpose of this study was to evaluate the feasibility of targeted fibroblast activation protein (FAP) molecular imaging in the early evaluation of diabetic cardiac fibrosis using [68Ga]Ga-DOTA-FAPI-04 PET/CT. PET/CT imaging was conducted in db/db mice and db/m mice at weeks 12 and 24. Diabetic heart injury was determined using echocardiography and serum biomarkers. Additionally, the levels of cardiac fibrosis were also assessed. In our study, conventional diagnostic modalities, including echocardiography and serum biomarkers, failed to monitor early-stage cardiac dysfunction and fibrosis in diabetic mice. Conversely, the results of [68Ga]Ga-DOTA-FAPI-04 PET/CT imaging demonstrated that diabetic mice had increased myocardial uptake of radioactive tracers in both early-stage and late-stage diabetes, consistent with the elevated FAP expression and increased cardiac fibrosis level. Notably, cardiac PET signals exhibited significant correlations with left ventricular ejection fractions, the E/A ratio, and the level of serum TGF-β1, PIIINP, and sST2. The results demonstrated the potential of [68Ga]Ga-DOTA-FAPI-04 PET/CT imaging for visualizing activated fibroblasts and detecting early-stage diabetic heart injury and fibrosis noninvasively. They also demonstrated the clinical superiority of [68Ga]Ga-DOTA-FAPI-04 PET/CT imaging over echocardiography and serum biomarkers in the early monitoring of diabetes-related cardiac dysfunction and fibrosis.

Revolutionising conservative dentistry: Exploring the impact and evolution of digital impression techniques in contemporary dental practice

Digital dental impression technology has emerged as a transformative innovation in conservative dentistry, revolutionizing the process of obtaining accurate replicas of dental structures. This review explores the evolution, advantages, and implications of digital impression techniques in contemporary dental practice. From intraoral scanners to CAD/CAM technology and 3D printing, digital systems offer enhanced accuracy, efficiency, and patient comfort compared to conventional methods. Studies demonstrate the clinical acceptability and superiority of digital impressions for fabricating dental restorations and prosthetics, with reduced operation time and improved patient experience. The widespread adoption of digital technology heralds a new era in dentistry, promising streamlined workflows, superior restoration quality, and enhanced patient satisfaction. Embracing digital impression technology is essential for dental practitioners to remain at the forefront of modern dentistry and deliver optimal patient care.

Ribociclib + adjuvant hormone therapy in early breast cancer: prevention of recurrence. New opportunities. A review

Breast cancer (BC) occupies a leading position among all malignant neoplasms in women worldwide and is the 4th deadliest. Most cases are diagnosed in stages I–III. Among the molecular biological variants, luminal HER2 negative (HER2-) prevails, accounting for 70–75%. Currently, therapies combining surgery with chemotherapy and, more rarely, radiation therapy, followed by adjuvant hormone therapy for up to 10 years, are a standard of care in BC. The goal of these regimens is the prevention of early recurrence in patients in the high-risk group with a primary hormone-resistant tumor. However, at the end of treatment, it occurs in 27–57% of patients with stage II–III breast cancer. For its prevention in early HR-positive (HR+) HER2- BC, an innovative class of drugs, cyclin-dependent kinase 4/6 inhibitors, is used combined with hormone therapy (aromatase inhibitors, anti-estrogens, gonadotropin-releasing hormone agonists), which is the subject of a randomized phase III NATALEE study evaluating the efficacy and safety of ribociclib in combination with endocrine therapy in early non-metastatic BC. The study enrolled patients with stage II–III breast cancer, including those with N0. Patients of the study group received ribociclib at a dose of 400 mg/day for 21 days in combination with aromatase inhibitors, and in the control group, only aromatase inhibitors. The median follow-up was 34 months. Three-year survival without invasive disease was 90.7% in the ribociclib group and 87.6% in controls. The risk of distant metastasis and invasive diseases was reduced by 25.1% in the ribociclib group. Therefore, ribociclib tended to improve overall survival. The initial dose of 400 mg/day reduced the incidence of adverse events; the most common were neutropenia (62.5%), arthralgia (37.3%) and hepatic toxicity (26.4%). The most common reasons for discontinuing ribociclib were hepatic toxicity (8.9%) and arthralgia (1.3%). The results demonstrate a statistical and clinical superiority of ribociclib in combination with hormone therapy in the treatment of early HR+ HER2- breast cancer with a high risk of recurrence.

Zero Self-Harm app: a mobile phone application to reduce non-suicidal self-injury—study protocol for a randomized controlled trial

BackgroundNon-suicidal self-injury (NSSI) is a growing healthcare problem. Individuals with NSSI have an increased risk of suicidality. Due to stigma, they may self-injure in secret, which means they might not seek help until events have escalated to include suicidal ideation or a mental disorder. Interventions delivered via mobile phone applications (apps) have been linked to reductions in self-injury. This protocol outlines a trial, which examines whether the Zero Self-Harm intervention, consisting of an app for people with NSSI, can reduce the number of NSSI episodes, suicide ideation, and depressive symptoms.MethodsThe trial will be conducted as a 6-month 2-arm, parallel-group, multicentre, pragmatic, randomized clinical superiority trial. The intervention group will receive the app and instructions on how to use it, while the control group will be allocated to a waitlist and allowed to download the app after 6 months. After inclusion, participants will be asked to complete questionnaires at baseline, 3 months, and 6 months. The primary outcome is the number of NSSI episodes during the preceding month, as measured at the 6 months follow-up with the Deliberate Self-Harm Inventory. A total of 280 participants, 140 in each arm, will be included.DiscussionThis trial will assess the effectiveness of the Zero Self-Harm intervention to reduce the number of NSSI episodes. If effective, the app will have the potential to support a large group of people with NSSI. Considering the stigma related to NSSI, the fact that the app may be used in private and anonymously might make it an appealing and acceptable option for support. The app was developed in collaboration with people with lived experiences related to current and/or previous NSSI. As a result of this, the app focuses on minimizing harm, rather than stopping NSSI. This might enhance its utilization.Trial registrationClinicalTrials.gov NCT04463654. Registered on 7 June 2020.

Glycemic Management Around Postprandial Exercise in People With Type 1 Diabetes: Challenge Accepted.

The precise glycemic impact and clinical relevance of postprandial exercise in type 1 diabetes (T1D) has not been clarified yet. This work aimed to examine acute, subacute, and late effects of postprandial exercise on blood glucose (BG). A randomized, controlled trial comprised 4 laboratory visits, with 24-hour follow-up at home. Participants included adults with T1D (n = 8), aged 44 ± 13 years, with body mass index of 24 ± 2.1. Intervention included 30 minutes of rest (CONTROL), walking (WALK), moderate-intensity (MOD), or intermittent high-intensity (IHE) exercise performed 60 minutes after a standardized meal. Main outcome measures included BG change during exercise/control (acute), and secondary outcomes included the subacute (≤2 h after) and late glycemic effects (≤24 h after). Exercise reduced postprandial glucose (PPG) excursion compared to CONTROL, with a consistent BG decline in all patients for all modalities (mean declines -45 ± 24, -71 ± 39, and -35 ± 21 mg/dL, during WALK, MOD, and IHE, respectively (P < .001). For this decline, clinical superiority was demonstrated separately for each exercise modality vs CONTROL. Noninferiority of WALK vs MOD was not demonstrated, noninferiority of WALK vs IHE was demonstrated, and equivalence of IHE vs MOD was not demonstrated. Hypoglycemia did not occur during exercise. BG increased in the hour after exercise (more than after CONTROL; P < .001). More than half of participants showed hyperglycemia after exercise necessitating insulin correction. There were more nocturnal hypoglycemic events after exercise vs CONTROL (P < .05). Postprandial exercise of all modalities is effective, safe, and feasible if necessary precautions are taken (ie, prandial insulin reductions), as exercise lowered maximal PPG excursion and caused a consistent and clinically relevant BG decline during exercise while there was no hypoglycemia during or shortly after exercise. However, there seem to be 2 remaining challenges: subacute postexercise hyperglycemia and nocturnal hypoglycemia.

Robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: a randomized controlled study (RObese)

BackgroundNearly 65% of patients with endometrial cancer who undergo primary hysterectomy have concurrent obesity. Retrospective data show advantages in using robotic surgery in these patients compared with conventional laparoscopy, namely...

Effect of intranasal sufentanil on acute post-traumatic pain in the emergency department: a randomised controlled trial

BackgroundIntranasal sufentanil is a potent opioid which can be used in patients with traumatic injuries presenting to the ED. Although previous studies have demonstrated the superiority of intranasal sufentanil over...

Multi-failure psoriasis patients: characterization of the patients and response to biological therapy in a multicenter Italian cohort.

Patients with psoriasis who have failed multiple biologic drugs have been defined as "multi-failure," although there are no clear data on the characteristics, comorbidities, and best treatment strategies for this population. Nowadays, given the next generation and the number of biologics available, patients are considered multi-failure when ≥4 biologics fail to achieve a good response. Demographic characteristics and efficacy of anti-interleukin drugs in multi-failure patients were compared to a cohort of general psoriatic patients treated with IL-23 or IL-17 inhibitors. In total 97 multi-failure patients (≥4 lines of biologics) were compared with 1,057 patients in the general cohort. The current drugs in the multi-failure group were risankizumab (34), ixekizumab (23), guselkumab (21), brodalumab (7), tildrakizumab (5), ustekinumab (4), secukinumab (2), and certolizumab pegol (1). A significant difference was found in the multi-failure cohort for age of psoriasis onset (mean 29.7 vs. 35.1, P < 0.001), concurrent psoriatic arthritis (45.4 vs. 26.9%, P < 0.001), diabetes mellitus (30.9 vs. 10.9%, P < 0.001), and cardiovascular comorbidity (54.6 vs. 39.8%, P = 0.005). In multi-failure patients, current biological therapy showed a good initial response (PASI 90 and 100 of 41.24 and 27.84%, respectively, at 16 weeks); the response tended to decline after 40 weeks. Anti-IL-17 agents showed clinical superiority over IL-23 agents in terms of achieving PASI90 at 28 weeks (P < 0.001) and 40 weeks (P = 0.007), after which they reached a plateau. In contrast, IL-23 agents showed a slower but progressive improvement that was maintained for up to 52 weeks. A similar trend was also seen for PASI100 (28 weeks P = 0.032; 40 weeks P = 0.121). The multi-failure patient is characterized by many comorbidities and longstanding inflammatory disease that frequently precedes the introduction of systemic biologic therapy. Further studies are needed to identify more specific criteria that could be applied as a guideline by clinicians.