Blinded Review Research Articles

A Scholarly Review and Case Study of Scrotal Abscess Resulting from Perforated Appendicitis

A Scholarly Review and Case Study of Scrotal Abscess Resulting from Perforated Appendicitis

Posterior Tibial Slope Measured on Plain Radiograph Versus MRI and Its Association With Revision Anterior Cruciate Ligament Reconstruction: A Matched Case-Control Study.

Posterior tibial slope (PTS) has been identified as a possible modifiable risk factor for anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) failure. However, the findings in the literature are inconsistent. This may be explained by several different reasons, including different measurement methods, differing definitions of ACLR failure, and possible inclusion of suboptimal films. To compare PTS values obtained using plain radiographs (XR-PTS) in a young (≤21 years of age), skeletally mature patient population with those obtained using magnetic resonance imaging (MRI), as well as to quantify the number of suboptimal lateral knee radiographs obtained across an integrated health care system and determine the potential effect of including these radiographs on summary statistics of XR-PTS. Case-control study; Level of evidence, 3. Skeletally mature adolescent and young adult patients ≤21 years of age were identified from the ACLR registry of Kaiser Permanente. The cases of concern were patients requiring revision ACLR. The controls were patients who had an ACLR and did not require a revision procedure. The XR-PTS measurements were made on plain radiographs by a single blinded reviewer. These results were compared with measurements obtained using MRI. The quality of each plain radiograph was evaluated by measuring posterior/distal femoral condylar overlap and length of tibial diaphysis captured on the radiograph. Summary statistics with and without inclusion of measurements made on suboptimal radiographs were calculated. Of the initial 634 patients with ACLR (317 case-control pairs), 561 (88.5%) had radiographs available and were included for the analysis comparing radiograph to MRI slope measurements. For the evaluation of slope between case and control pairs with radiograph information available, there were 257 case-control pairs; there were 124 pairs when those with suboptimal radiographs were excluded. There was no difference in MRI-measured lateral tibial posterior slope or medial tibial posterior slope for the 257 case-control pairs with XR-PTS information and for the 124 pairs with optimal radiographs. XR-PTS in the revision cohort was significantly steeper than in the control group when suboptimal radiographs were included in the analysis. There was no difference when patients with suboptimal radiographs were excluded. PTS measurements made on plain radiographs were larger than those made on MRI. There was a poor correlation between measurements made using these 2 modalities (r = 0.22 for radiograph and medial PTS). This study did not find a significantly steeper XR-PTS in patients who had to undergo revision ACLR when suboptimal radiographs were not included in the analysis. The present study's results confirmed the findings from a previous study of the same patient population that used MRI. However, there was poor correlation between PTS measurements made using plain radiograph and MRI.

Upscaling cargo bike sharing in cities: A comparative case study

Urban mobility transitions are essential to mitigate climate change and improve the quality of life in cities. Cargo bikes (CBs) show promise in replacing motorised vehicles due to their lower carbon intensity, space efficiency, and ability to reduce air and noise pollution. CB sharing relieves users from purchase and maintenance costs. However, it is mainly adopted by individuals with high environmental awareness. Barriers to CB sharing stem from the urban infrastructure, individual mobility choices, and the design of CB sharing organisations (CBSOs). This article analyses upscaling pathways for CB sharing, i.e., increasing their use by a broader audience and reshaping the urban mobility regime. It delivers a comparative case study analysis of two CBSOs: Grätzlrad, Vienna, and LastenVelo e.V., Freiburg. Data was collected through academic and grey literature review and 15 semi-structured interviews with CB sharing stakeholders and experts. The analytical framework is informed by strategic niche management, viewing CB sharing as a niche innovation in the urban mobility regime. The article enhances understanding of CB sharing, the interaction of CBSOs with key actors, and their scalability. CBSOs should increase the availability of shared CBs while reducing the organisational effort required from users. New ways of CB sharing, e.g., integration in shared mobility hubs, should be explored. Municipal actors play a crucial role in upscaling and ensuring that CB sharing reaches a diverse user base. The findings are useful for academia, practitioners and policymakers working with CB sharing and other sustainable urban mobility solutions.

Analyzing the Performance Trends in Licensure Examination for Teachers (LET) Among Bachelor of Elementary Education (BEEd) Graduates: A Quantitative Approach

The study analyzes the performance trends in the Licensure Examination for Teachers (LET) among Bachelor of Elementary Education (BEEd) graduates from Sultan Kudarat State University – Kalamansig Campus from 2018 to 2023. A descriptive-comparative research design was employed to statistically measure the objectives of the study. Data were obtained from the Professional Regulation Commission (PRC). The study’s respondents are 73 first-timers and 112 repeaters. A total of 185 BEEd examinees were the respondents of the study. Also, the study utilized frequency and percentage counts, z-scores, and p-values to compare the performance and test for significant differences. The results revealed that the performance trends among the BEEd graduates was fluctuating. Performance of first-timers are higher than repeaters in most periods, with institutional passing rates below national passing rates. Notably, exceptional performances were recorded during the March 2019, June 2022, and October 2022 examination periods, where institutional passing rates surpassed national passing rates. The study identifies several factors influencing LET performance, including academic preparation, review sessions, and external disruptions such as the COVID-19 pandemic, which impacted the consistency and preparation of examinees. The data suggest that while first-timers showed relatively strong performance, repeaters faced significant challenges, underscoring the need for targeted support systems to enhance their preparedness and outcomes. The findings highlight the critical importance of continuous monitoring and strategic interventions to improve LET performance. Implementing effective support mechanisms for repeaters, improving academic and review processes, and addressing external factors are essential steps toward enhancing the quality of teacher education.

The 2910-nm Fiber Laser Is Safe and Effective for Improving Acne Scarring.

Acne scarring results from the inflammation associated with acne papules, which alters dermal collagen, typically producing depressed scars. Lasers have been used to remodel skin improving the texture and appearance of acne scars. Herein, we investigate a new 2910 nm, erbium-doped, fluoride glass, fiber laser for improving acne scars. This novel laser delivers up to 5000 Hz low-energy pulses, providing a unique treatment modality. Fourteen subjects with rolling and/or boxcar acne scars were enrolled in this study. Thirteen subjects completed the final visit and received three treatments with the 2910 nm fiber laser at 6-8-week intervals. Eight subjects were Fitzpatrick type II and five were Fitzpatrick type III. Digital images were taken pre- and 1- and 3-months posttreatment and evaluated by two blinded reviewers in a randomized fashion for improvement. Subjects and the treating physician completed a Global Aesthetic Improvement Scale (GAIS) before treatment and at each visit to subjectively evaluate treatment effect. Histological analysis was performed on ex vivo lower eyelid skin samples. Side effects were evaluated by the treating physician and included erythema, edema, and pinpoint bleeding. Evaluation of blinded digital images revealed a mean improvement of 47.3% ± 14.2% (mean ± SEM) 3 months following the final treatment. GAIS scores demonstrated improvement as evaluated by both the subjects and the treating physician. Side effects averaged trace-to-mild erythema, edema, and pinpoint bleeding. This study shows that the 2910 nm, erbium-doped, fluoride glass, fiber laser is safe and effective for improving the appearance of acne scars.

Appropriate antimicrobial prescribing for bacteriuria before urological procedures: A room for improvement

In the presence of a positive preoperative urine culture, the prescription of a preoperative antibiotic therapy is recommended. The choice of antibiotic therapy and prescription are usually made by the urologist or the general practitioner (GP). The objective of the treatment is urinary sterilization rather than parenchymal treatment, and the treatment choice is key to reduce selective pressure and antimicrobial resistance. The objective of this study was to evaluate prescription patterns made by urologists and GPs, then to compare the antibiotics chosen by urologists or GPs to the “ideal” treatment defined by infectious diseases specialists. We retrospectively reviewed all positive preoperative urine cultures obtained between November 2022 and July 2023. Data pertaining to antibiotic prescriptions, including the duration of treatment, antibiotic class, and prescriber were collected. An infectious disease specialist conducted a blind review of each urine culture, providing recommendations for the most appropriate antibiotic based on their assessment. In cases of disagreement, a second infectious disease specialist conducted a similar evaluation. Out of 196 preoperative antibiotic prescriptions, 40 (20%) differed from the recommendations provided by the infectious disease specialist, with 39 involving the use of overly broad-spectrum antibiotics. Both infectious disease specialists yielded congruent recommendations in all cases. Notably, in 50% of these instances, the preoperative antibiotic treatment duration unduly exceeded 48hours. A statistically significant increase (4.84days vs. 2.99days) in preoperative treatment duration was observed when a GP was the prescriber (P<0.001). There is room for improvement of urologists’ antibiotic prescription practices to reduce the ecological impact on the patient's microbiota and on a global scale. The delegation to GPs resulted in unjustified longer treatment durations and should be avoided without dedicated training. Level of evidence4.

Performance of Publicly Available Large Language Models on Internal Medicine Board-style Questions.

Ongoing research attempts to benchmark large language models (LLM) against physicians' fund of knowledge by assessing LLM performance on medical examinations. No prior study has assessed LLM performance on internal medicine (IM) board examination questions. Limited data exists on how knowledge supplied to the models, derived from medical texts improves LLM performance. The performance of GPT-3.5, GPT-4.0, LaMDA and Llama 2, with and without additional model input augmentation, was assessed on 240 randomly selected IM board-style questions. Questions were sourced from the Medical Knowledge Self-Assessment Program released by the American College of Physicians with each question serving as part of the LLM prompt. When available, LLMs were accessed both through their application programming interface (API) and their corresponding chatbot. Mode inputs were augmented with Harrison's Principles of Internal Medicine using the method of Retrieval Augmented Generation. LLM-generated explanations to 25 correctly answered questions were presented in a blinded fashion alongside the MKSAP explanation to an IM board-certified physician tasked with selecting the human generated response. GPT-4.0, accessed either through Bing Chat or its API, scored 77.5-80.7% outperforming GPT-3.5, human respondents, LaMDA and Llama 2 in that order. GPT-4.0 outperformed human MKSAP users on every tested IM subject with its highest and lowest percentile scores in Infectious Disease (80th) and Rheumatology (99.7th), respectively. There is a 3.2-5.3% decrease in performance of both GPT-3.5 and GPT-4.0 when accessing the LLM through its API instead of its online chatbot. There is 4.5-7.5% increase in performance of both GPT-3.5 and GPT-4.0 accessed through their APIs after additional input augmentation. The blinded reviewer correctly identified the human generated MKSAP response in 72% of the 25-question sample set. GPT-4.0 performed best on IM board-style questions outperforming human respondents. Augmenting with domain-specific information improved performance rendering Retrieval Augmented Generation a possible technique for improving accuracy in medical examination LLM responses.

Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study

Distant metastases in non-small-cell lung cancer (NSCLC) are a poor prognostic factor that negatively impact quality of life. The central nervous system (CNS) is a common site of distant progression in epidermal growth factor receptor-mutated (EGFRm) NSCLC. Osimertinib is a third-generation EGFR-tyrosine kinase inhibitor recommended for advanced EGFRm NSCLC and as adjuvant treatment for resected EGFRm NSCLC. In LAURA (NCT03521154), osimertinib demonstrated statistically significant improvement in progression-free survival (PFS) versus placebo in unresectable stage III EGFRm NSCLC without progression during/following chemoradiotherapy (CRT). CNS efficacy and time to death or distant metastases (TTDM) analyses are reported here. Patients without progression during/following definitive platinum-based CRT were randomised 2 : 1 to receive osimertinib (80 mg daily) or placebo until progression [by blinded independent central review (BICR)] or discontinuation. The primary endpoint was PFS by BICR. CNS PFS by neuroradiologist BICR and TTDM by BICR were secondary endpoints. Overall, 216 patients were randomised (143 osimertinib, 73 placebo). Median CNS PFS by neuroradiologist BICR was not reached [95% confidence interval (CI) not calculable (NC)-NC] with osimertinib versus 14.9 months (95% CI 7.4 months-NC) with placebo; hazard ratio (HR) for CNS PFS: 0.17 (95% CI 0.09-0.32). CNS PFS analysis by investigator assessment was consistent with BICR assessment. The cumulative incidence of CNS progression at 12 months was 9% (95% CI 5% to 14%) with osimertinib and 36% (95% CI 24% to 47%) with placebo. There was clinically meaningful improvement in TTDM with osimertinib versus placebo; HR for TTDM: 0.21 (95% CI 0.11-0.38). The cumulative incidence of distant metastases at 12 months was 11% (95% CI 6% to 17%) with osimertinib and 37% (95% CI 26% to 48%) with placebo. Osimertinib demonstrated clinically meaningful improvements in CNS PFS and TTDM versus placebo, supporting osimertinib post-CRT as the standard of care in unresectable stage III EGFRm NSCLC.

Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors.

Treatment options for patients with advanced neuroendocrine tumors are limited. The efficacy of cabozantinib in the treatment of previously treated, progressive extrapancreatic or pancreatic neuroendocrine tumors is unclear. We enrolled two independent cohorts of patients - those with extrapancreatic neuroendocrine tumors and those with pancreatic neuroendocrine tumors - who had received peptide receptor radionuclide therapy or targeted therapy or both. Patients were randomly assigned in a 2:1 ratio to receive cabozantinib at a dose of 60 mg daily or placebo. The primary end point was progression-free survival as assessed by blinded independent central review. Key secondary end points included objective response, overall survival, and safety. In the cohort of 203 patients with extrapancreatic neuroendocrine tumors, the median progression-free survival with cabozantinib was 8.4 months, as compared with 3.9 months with placebo (stratified hazard ratio for progression or death, 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001). In the cohort of 95 patients with pancreatic neuroendocrine tumors, the median progression-free survival with cabozantinib was 13.8 months, as compared with 4.4 months with placebo (stratified hazard ratio, 0.23; 95% CI, 0.12 to 0.42; P<0.001). The incidence of confirmed objective response with cabozantinib was 5% and 19% among patients with extrapancreatic and pancreatic neuroendocrine tumors, respectively, as compared with 0% with placebo. Grade 3 or higher adverse events were noted in 62 to 65% of the patients treated with cabozantinib, as compared with 23 to 27% of the patients who received placebo. Common treatment-related adverse events of grade 3 or higher included hypertension, fatigue, diarrhea, and thromboembolic events. Cabozantinib, as compared with placebo, significantly improved progression-free survival in patients with previously treated, progressive advanced extrapancreatic or pancreatic neuroendocrine tumors. Adverse events were consistent with the known safety profile of cabozantinib. (Funded by the National Cancer Institute and others; CABINET ClinicalTrials.gov number, NCT03375320.).

The Multifaceted Therapeutic Profile of Madecassoside: A Scholarly Review

Medicinal plants are indispensable in both modern and traditional healthcare, offering a diverse array of bioactive compounds with therapeutic properties, including anti-inflammatory, antimicrobial, and anticancer effects. They provide accessible and affordable treatment options and play a crucial role in drug discovery, enhancing holistic health and promoting biodiversity conservation. Ongoing scientific research continues to validate and expand their applications in contemporary medicine, underscoring their enduring significance. Centella asiatica, a medicinal plant known for its therapeutic properties in traditional medicine and increasingly recognized in modern pharmacology for various health benefits. Madecassoside, stands out as a phytoactive constituent of Centella asiatica, renowned for its wide-ranging pharmacological properties, encompassing anti-inflammatory, antioxidant, wound-healing, and skin-protective effects. The present review illuminates madecassoside's pharmacological properties and its mechanistic roles, as documented by various researchers. Keywords: Madecassoside, Centella asiatica, anti-inflammatory, antioxidant, wound-healing

How to review a submitted dermatology manuscript.

Although much has been written about peer review science, practical advice on HOW to peer review articles is lacking, especially for Dermatology. This article aims to provide a practical, stepwise framework to support new reviewers. Step 1 involves a rapid read of the manuscript to get a feel of the topic and to clarify the study question and design. Step 2 is a thorough slower read, using an appropriate EQUATOR checklist. Step 3 is to organise your comments to authors into major and minor points in a constructive way, focusing on clarity of question, internal validity, external validity and whether interpretation fits with the results. Finally, make a recommendation to the editor, indicating whether the study is publishable with suitable revision or whether it contains some fatal flaws. We hope that this practical guide will encourage and help new reviewers to take on this rewarding and important scientific task for patient benefit.

Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer.

Outcomes in patients with hormone receptor-positive metastatic breast cancer worsen after one or more lines of endocrine-based therapy. Trastuzumab deruxtecan has shown efficacy in patients with metastatic breast cancer with low expression of human epidermal growth factor receptor 2 (HER2) after previous chemotherapy. We conducted a phase 3, multicenter, open-label trial involving patients with hormone receptor-positive metastatic breast cancer with low HER2 expression (a score of 1+ or 2+ on immunohistochemical [IHC] analysis and negative results on in situ hybridization) or ultralow HER2 expression (IHC 0 with membrane staining) who had received one or more lines of endocrine-based therapy and no previous chemotherapy for metastatic breast cancer. Patients were randomly assigned in a 1:1 ratio to receive trastuzumab deruxtecan or the physician's choice of chemotherapy. The primary end point was progression-free survival (according to blinded independent central review) among the patients with HER2-low disease. Secondary end points included progression-free survival among all the patients who had undergone randomization, overall survival, and safety. Of the 866 patients who underwent randomization, 713 had HER2-low disease, and 153 had HER2-ultralow disease. Among the patients with HER2-low disease, the median progression-free survival was 13.2 months (95% confidence interval [CI], 11.4 to 15.2) in the trastuzumab deruxtecan group and 8.1 months (95% CI, 7.0 to 9.0) in the chemotherapy group (hazard ratio for disease progression or death, 0.62; 95% CI, 0.51 to 0.74; P<0.001); the results were consistent in the exploratory HER2-ultralow population. Data for overall survival were immature. Adverse events of grade 3 or higher occurred in 52.8% of the patients in the trastuzumab deruxtecan group and in 44.4% of those in the chemotherapy group. Adjudicated interstitial lung disease or pneumonitis occurred in 49 patients (11.3%; three events were grade 5 in severity) and in 1 patient (0.2%; grade 2), respectively. Among patients with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer who had received one or more lines of endocrine-based therapy, treatment with trastuzumab deruxtecan resulted in longer progression-free survival than chemotherapy. No new safety signals were identified. (Funded by AstraZeneca and Daiichi Sankyo; DESTINY-Breast06 ClinicalTrials.gov number, NCT04494425.).

Acalabrutinib in Chinese patients with relapsed/refractory chronic lymphocytic leukemia: Primary analysis from an open-label, multicenter phase 1/2 trial.

Acalabrutinib is a highly selective Bruton tyrosine kinase inhibitor approved in the United States and Europe for chronic lymphocytic leukemia (CLL) based on phase 3 trials with limited representation of Asian populations. This phase 1/2 trial evaluates acalabrutinib in Chinese adults with relapsed/refractory (R/R) CLL receiving acalabrutinib 100mg twice daily in 28-day cycles until disease progression or treatment discontinuation due to adverse events (AEs) presenting substantial clinical risk. The primary endpoint was blinded independent central review (BICR)-assessed overall response rate (ORR). A total of 60 patients from 20 sites in China received acalabrutinib (median age 62years; median 1 prior therapy line; 21.7% with del(17p) and/or TP53 mutation; 51.7% with unmutated IGHV). Median total treatment duration was 19.4months (range 0.6-28.2) with 53 patients (88.3%) receiving acalabrutinib at data cutoff; median study follow-up was 20.2months. BICR-assessed ORR was 85.0% (95% CI, 73.4-92.9). Median duration of response, progression-free survival (PFS), and overall survival (OS) were not reached. Estimated 12-month and 18-month PFS rates were 91.5% (95% CI, 80.9-96.4) and 78.8% (95% CI, 60.9-89.2); OS rates were both 96.7% (95% CI, 87.3-99.2). AEs of grade ≥ 3 occurred in 25 patients (41.7%), most commonly decreased neutrophil count (13.3%, n = 8), pneumonia (6.7%, n = 4), and upper respiratory tract infection (6.7%, n = 4). AEs led to treatment discontinuation in 2 patients (paraneoplastic pemphigus; rectal neoplasm). This study demonstrated high ORR in acalabrutinib-treated Chinese patients with R/R CLL with no unexpected safety concerns. This trial is registered on ClinicalTrials.gov (NCT03932331).

Publisher Correction: Deciphering the world of NFTs: a scholarly review of trends, challenges, and opportunities

Publisher Correction: Deciphering the world of NFTs: a scholarly review of trends, challenges, and opportunities

Mixed martial arts athletes demonstrate different brain vital sign profiles compared to matched controls at baseline.

We investigated objective brain vital signs derived from event-related potentials (ERPs) for mixed martial arts (MMA) athletes and matched controls (N = 24). Brain vital sign scans were acquired from 9 MMA athletes and 15 age-and sex-matched controls. Our analysis specifically compared differences in brain vital signs between MMA athletes and controls at baseline. We predicted that MMA athletes would show significant differences relative to controls due to their ongoing exposure to repetitive head impacts. Participants were scanned to extract three well-established ERPs: N100 for auditory sensation; P300 for basic attention; and N400 for cognitive processing. Scans were verified using automated reports, with N100, P300, and N400 amplitudes and latencies manually identified by a blinded reviewer. Brain vital signs were compared across groups with a Kruskal-Wallis H-test for independent samples, with FDR correction for multiple comparisons. We identified significant differences between MMA athletes and controls. Specifically, there were significant N400 amplitude reductions, indicating that exposure to repetitive head impacts in MMA may be associated with changes in brain function.

Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: Primary Results From TROPION-Breast01.

The global, phase 3, open-label, randomized TROPION-Breast01 study assessed the trophoblast cell surface antigen 2-directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) versus investigator's choice of chemotherapy (ICC) in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. Adult patients with inoperable/metastatic HR+/HER2‒ breast cancer, who had disease progression on endocrine therapy, for whom endocrine therapy was unsuitable, and had received one to two previous lines of chemotherapy in the inoperable/metastatic setting, were randomly assigned 1:1 to Dato-DXd (6 mg/kg once every 3 weeks) or ICC (eribulin/vinorelbine/capecitabine/gemcitabine). Dual primary end points were progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS). Patients were randomly assigned to Dato-DXd (n = 365) or ICC (n = 367). Dato-DXd significantly reduced the risk of progression or death versus ICC (PFS by BICR hazard ratio [HR], 0.63 [95% CI, 0.52 to 0.76]; P < .0001). Consistent PFS benefit was observed across subgroups. Although OS data were not mature, a trend favoring Dato-DXd was observed (HR, 0.84 [95% CI, 0.62 to 1.14]). The rate of grade ≥3 treatment-related adverse events (TRAEs) with Dato-DXd was lower than ICC (20.8% v 44.7%). The most common TRAEs (any grade; grade ≥3) were nausea (51.1%; 1.4%) and stomatitis (50%; 6.4%) with Dato-DXd and neutropenia (grouped term, 42.5%; 30.8%) with ICC. Patients receiving Dato-DXd had statistically significant and clinically meaningful improvement in PFS and a favorable and manageable safety profile, compared with ICC. Results support Dato-DXd as a novel treatment option for patients with inoperable/metastatic HR+/HER2‒ breast cancer who have received one to two previous lines of chemotherapy in this setting.

Brief Cognitive Behavioral Therapy for Suicidal Inpatients

Suicide risk is elevated after discharge from inpatient level of care. Empirically supported inpatient suicide prevention treatments are needed. To determine whether adding an inpatient version of brief cognitive behavioral therapy for suicide prevention to treatment as usual reduces postdischarge suicide attempts, suicidal ideation, and psychiatric readmissions and to determine whether substance use disorder moderates treatment effects. This randomized clinical trial compared treatment as usual (n = 106) to treatment as usual plus brief cognitive behavioral therapy for inpatients (n = 94) at a private psychiatric hospital in Connecticut. Follow-up assessments were completed monthly for 6 months postdischarge. Participants were enrolled from January 2020 through February 2023. Inpatients admitted following a suicidal crisis (past-week suicide attempt or ideation with plan on admission and attempt within previous 2 years) were included. Medical records of consecutive admissions (n = 4137) were screened, 213 were study eligible and randomized, and 200 were analyzed. A total of 114 participants (57.0%) completed 6-month follow-up assessments. Data from medical records were also obtained through 6-month follow-up. Up to 4 individual sessions of brief cognitive behavioral therapy for suicide prevention designed for inpatients. Suicide attempts and readmissions were assessed via blind interviews and medical record review. Suicidal ideation was assessed via self-report. The mean (SD) age among 200 analyzed participants was 32.8 (12.6) years; 117 participants were female and 83 were male. Brief cognitive behavioral therapy-inpatient reduced the occurrence of suicide attempt over 6 months postdischarge by 60% (odds ratio, 0.40; 95% CI, 0.20-0.80; number needed to treat, 7) in the entire patient group, and the rate of psychiatric readmissions by 71% (rate ratio, 0.29; 95% CI, 0.09-0.90) in those without a substance use disorder. The effect of treatment condition on suicidal ideation was less clear, although post hoc analyses indicated less severe suicidal ideation following brief cognitive behavioral therapy-inpatient vs treatment as usual at 1 and 2 months postdischarge. Brief cognitive behavioral therapy-inpatient reduced 6-month postdischarge suicide reattempts and rate of readmissions when added to treatment as usual. Substance use disorder moderated the treatment's effect on readmission rates. Treatment effects on suicidal ideation were less clear. Implementation research is needed to facilitate dissemination. Additional research is also needed to optimize outcomes for individuals with substance use disorders. ClinicalTrials.gov Identifier: NCT04168645.

[89Zr]Zr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial

With limitations of conventional imaging and biopsy, accurate, non-invasive techniques to detect clear-cell renal cell carcinoma in patients with renal masses remain an unmet need. 89Zr-labelled monoclonal antibody ([89Zr]Zr-girentuximab) has high affinity for carbonic anhydrase 9, a tumour antigen highly expressed in clear-cell renal cell carcinoma. We aimed to evaluate [89Zr]Zr-girentuximab PET-CT imaging for detection and characterisation of clear-cell renal cell carcinoma. ZIRCON was a prospective, open-label, multicentre, phase 3 trial conducted at 36 research hospitals and practices across nine countries (the USA, Australia, Canada, the UK, Türkiye, Belgium, the Netherlands, Spain, and France). Patients aged 18 years or older with an indeterminate renal mass 7 cm or smaller (cT1) suspicious for clear-cell renal cell carcinoma and scheduled for nephrectomy received a single dose of [89Zr]Zr-girentuximab (37 MBq ±10%; 10 mg girentuximab) intravenously followed by abdominal PET-CT imaging 5 days (±2 days) later. Surgery was performed no later than 90 days after administration of [89Zr]Zr-girentuximab. Blinded central review, conducted by three independent readers, determined the histology from surgical samples. The coprimary endpoints, determined for each individual reader, were the sensitivity and specificity of [89Zr]Zr-girentuximab PET-CT imaging to detect clear-cell renal cell carcinoma, with histopathological confirmation as standard of truth. Analyses were on the full analysis set of patients, defined as patients who had evaluable PET-CT imaging and a confirmed histopathological diagnosis. The trial is registered with ClinicalTrials.gov, NCT03849118, and EUDRA Clinical Trials Register, 2018-002773-21, and is closed to enrolment. Between Aug 14, 2019, and July 8, 2022, 371 patients were screened for eligibility, 332 of whom were enrolled. 300 patients received [89Zr]Zr-girentuximab (214 [71%] male and 86 [29%] female). 284 (95%) evaluable patients were included in the primary analysis. The mean sensitivity was 85·5% (95% CI 81·5-89·6) and mean specificity was 87·0% (81·0-93·1). No safety signals were observed. Most adverse events were not or were unlikely to be related to [89Zr]Zr-girentuximab, with most (193 [74%] of 261 events) occurring during or after surgery. The most common grade 3 or worse adverse events were post-procedural haemorrhage (in six [2%] of 261 patients), urinary retention (three [1%]), and hypertension (three [1%]). In 25 (8%) of 300 patients, 52 serious adverse events were reported, of which 51 (98%) occurred after surgery. There were no treatment-related deaths. Our results suggest that [89Zr]Zr-girentuximab PET-CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of clear-cell renal cell carcinoma, which has the potential to be practice changing. Telix Pharmaceuticals.

Minimally Invasive Surgery: A Paradigm Shift in Surgical Procedures

Minimally Invasive Surgery (MIS) and microsurgery have significantly transformed periodontal treatment by reducing tissue trauma and improving patient outcomes. MIS focuses on minimizing flap reflection and tissue manipulation, preserving blood supply, and ensuring the stability of blood clots at the wound site, which collectively reduce postoperative complications such as shrinkage and discomfort. Microsurgery, enabled by advancements in surgical microscopes, enhances visual acuity and allows for precise surgical interventions. In periodontology, the integration of MIS and microsurgery has led to refined surgical techniques that prioritize minimal tissue disruption, passive wound closure, and the use of specialized microsurgical instruments. These approaches offer significant advantages over conventional flap surgeries, which were often associated with extensive tissue damage, prolonged healing times, and aesthetic compromises. The evolution of MIS in periodontology represents a shift from resection-based procedures to those focused on regeneration, emphasizing the importance of skill enhancement and the adoption of advanced technologies. As MIS techniques continue to develop, they hold the potential to become the standard of care, providing patients with effective, less invasive treatment options that result in better clinical and aesthetic outcomes. The current article's goal was to gather and record different minimally invasive periodontology techniques. Peer-reviewed materials from journals, Medline/PubMed, Google Scholar, and other reviews served as the foundation for the research.

Roadmap for Linking Registry Data with Health Services Data to Support Evidence-Informed Decision-Making.

ApproachAs part of a learning period to optimize the use of RWE for decision-making for drugs for rare diseases, the [organization name removed to allow for blind review] conducted an environmental scan to map real-world data in patient registries. Over 400 patient registries were identified, signaling the potential wealth of untapped information to support decision-making by linking registry data with health services data. To better understand the challenges faced by registry holders hoping to link registry data with health services data sources available in Canada, a series of interviews were conducted with several Canadian rare disease registries. In addition, a literature review was completed, and Canadian experts in epidemiology, privacy, record linkage, registry science, and health services research were consulted to inform the development of a roadmap to meet various stakeholder needs. ResultsThe resulting roadmap consists of 8 specific steps covering topics related to registry purpose, informed consent, ethical approval, participant privacy, governance, data linkability, participant identifiability and jurisdictional requirements. ConclusionThe roadmap is currently undergoing pilot testing by a pan-Canadian rare disease registry. A final [organization name] report and an accompanying roadmap in a checklist format to facilitate implementation will be finalized, disseminated across key stakeholders, and made publicly available. ImplicationsWhile developed for registries, the roadmap applies to the linkage of clinical trial or cohort study data, or other systematically gathered patient-level data to health services data.