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IntroductionWe elicited Vietnamese Americans' perspectives on culturally appropriate recruitment into a new research registry: Collaborative Approach for Asian Americans, Native Hawaiians, and Pacific Islanders (AANHPIs) Research and Education (CARE).MethodsThree focus groups were conducted with 21 Vietnamese Americans. Topics included knowledge about and experiences with research, outreach and recruitment methods for research participation and registry enrollment, and views about research incentives. Focus group transcripts were analyzed thematically.ResultsMean age of participants was 41 years (range 18-73), 57% were male, 86% were non-US born, and 81% had never participated in a research study. Themes that emerged included (1) motivations to participate in research to gain knowledge: for oneself, for family's benefit, and for the Vietnamese American community as a whole; (2) necessity of trustworthy and credible individuals/spokespersons to promote the research initiative; (3) recruitment strategies that are age-specific and culturally appropriate, and (4) importance of monetary incentives.ConclusionFindings from this study will be used to guide recruitment into and engagement with CARE among Vietnamese Americans but are also relevant for other registries aiming to diversify their participants.

PURPOSE: Clinical trials are valuable evidence for managing urologic malignancies. Early termination of clinical trials is associated with a waste of resources and may substantially affect patient care. We sought to study the termination rate of urologic cancer clinical trials and identify factors associated with trial termination. METHODS: A cross-sectional search of ClinicalTrials.gov identified completed and terminated kidney, prostate, and bladder cancer clinical trials started. Trials were assessed for reasons for termination. Multivariable analyses were conducted to determine the significant factors associated with the termination. RESULTS: Between 2000 and 2020, 9,145 oncology clinical trials were conducted, of which 11.30% (n = 1,033) were urologic cancer clinical trials. Of the urologic cancer clinical trials, 25.38% (n = 265) were terminated, with low patient accrual being the most common reason for termination, 52.9% (n = 127). Multivariable analysis showed that only the university funding source odds ratio (OR) of 2.20 (95% CI, 1.45 to 3.32), single-center studies OR of 2.11 (95% CI, 1.59 to 2.81), and sample size of

Background: Children with inflammatory bowel disease (IBD) experience extraintestinal side effects including altered body composition, impaired muscle strength, and aerobic capacity. Exercise training may remedy these issues. Purpose: To assess the feasibility, safety, participant satisfaction, and efficacy of a training program for youth with IBD. Methods: Children with IBD completed 16 weeks of training (2 supervised + 1 home sessions per week). Feasibility was assessed by tracking recruitment, adherence, and compliance rates. Safety was assessed by tracking symptoms and adverse events. Posttraining interviews gauged satisfaction. Circulating inflammatory markers, body composition, muscle strength, aerobic fitness, and habitual physical activity were measured at baseline, midtraining (8 wk), and posttraining. Results: Eleven youth were recruited and 10 completed the study. Participants adhered to 28 (1) of 32 prescribed supervised sessions and 8 (4) of 16 prescribed home sessions. There were no adverse events, and overall feedback on training was positive. Posttraining, we observed an increase in lean mass (+2.4 [1.1] kg), bone density (+0.0124 [0.015] g·cm−2), aerobic fitness (+2.8 [5.7] mL·kg LM−1· min−1), and vigorous physical activity levels (+13.09 [8.95] min·h−1) but no change in inflammation or muscle strength. Conclusion: Supervised exercise training is feasible, safe, and effective for youth with IBD and should be encouraged. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Remote, internet-based methods for recruitment, screening, and longitudinally assessing older adults have the potential to facilitate Alzheimers disease (AD) clinical trials and observational studies. METHODS: The Brain Health Registry (BHR) is an online registry that includes longitudinal assessments including self- and study partner-report questionnaires and neuropsychological tests. New initiatives aim to increase inclusion and engagement of commonly underincluded communities using digital, community-engaged research strategies. New features include multilingual support and biofluid collection capabilities. RESULTS: BHR includes > 100,000 participants. BHR has made over 259,000 referrals resulting in 25,997 participants enrolled in 30 aging and AD studies. In addition, 28,278 participants are coenrolled in BHR and other studies with data linkage among studies. Data have been shared with 28 investigators. Recent efforts have facilitated the enrollment and engagement of underincluded ethnocultural communities. DISCUSSION: The major advantages of the BHR approach are scalability and accessibility. Challenges include compliance, retention, cohort diversity, and generalizability. HIGHLIGHTS: Brain Health Registry (BHR) is an online, longitudinal platform of > 100,000 members. BHR made > 259,000 referrals, which enrolled 25,997 participants in 32 studies. New efforts increased enrollment and engagement of underincluded communities in BHR. The major advantages of the BHR approach are scalability and accessibility. BHR provides a unique adjunct for clinical neuroscience research.

ObjectiveSignificant regional variation is known with multiple surgical procedures. This study describes regional variation in carotid revascularization within the Vascular Quality Initiative (VQI).MethodsData from the VQI carotid endarterectomy (CEA) and carotid artery stenting (CAS) databases from 2016 to 2021 were used. Nineteen geographic VQI regions were divided into three tertiles based on the average annual volume of carotid procedures performed per region (low-volume: 956 cases [range, 144-1382]; medium-volume: 1533 cases [range, 1432-1589]; and high-volume: 1845 cases [range, 1642-2059]). Patients' characteristics, indications for carotid revascularization, practice patterns, and outcomes (perioperative and 1-year stroke/death) of different revascularization techniques were compared between these regional groups. Regression models that adjust for known risk factors and allow for random effects at the center level were used.ResultsCEA was the most common revascularization procedure (>60%) across all regional groups. Significant regional variation was observed in the practice of CEA such as variability in the use of shunting, drain placement, stump pressure and electroencephalogram monitoring, intraoperative protamine, and patch angioplasty. For transfemoral CAS, high-volume regions had a higher proportion of asymptomatic patients with

As genetic code expansion advances beyond L-α-amino acids to backbone modifications and new polymerization chemistries, delineating what substrates the ribosome can accommodate remains a challenge. The Escherichia coli ribosome tolerates non-L-α-amino acids in vitro, but few structural insights that explain how are available, and the boundary conditions for efficient bond formation are so far unknown. Here we determine a high-resolution cryogenic electron microscopy structure of the E. coli ribosome containing α-amino acid monomers and use metadynamics simulations to define energy surface minima and understand incorporation efficiencies. Reactive monomers across diverse structural classes favour a conformational space where the aminoacyl-tRNA nucleophile is

Abstract Objective This systematic review aims to outline the use of population and disease registries for clinical trial pre-screening. Materials and methods The search was conducted in the time period of January 2014 to December 2022 in three databases: MEDLINE, Embase, and Web of Science Core Collection. References were screened using the Rayyan software, firstly based on titles and abstracts only, and secondly through full text review. Quality of the included studies was assessed using the List of Included Studies and quality Assurance in Review tool, enabling inclusion of publications of only moderate to high quality. Results The search originally identified 1430 citations, but only 24 studies were included, reporting the use of population and/or disease registries for trial pre-screening. Nine disease domains were represented, with 54% of studies using registries based in the USA, and 62.5% of the studies using national registries. Half of the studies reported usage for drug trials, and over 478,679 patients were identified through registries in this review. Main advantages of the pre-screening methodology were reduced financial burden and time reduction. Discussion and conclusion The use of registries for trial pre-screening increases reproducibility of the pre-screening process across trials and sites, allowing for implementation and improvement of a quality assurance process. Pre-screening strategies seem under-reported, and we encourage more trials to use and describe their pre-screening processes, as there is a need for standardized methodological guidelines.

Abstract This scoping review aimed to determine whether the COVID‐19 pandemic influenced any modifications to patient selection methods or prioritisation and services provided by proton therapy (PT) centres. This review was conducted based on the PRISMA methodology and Joanna Briggs Institute scoping review guidelines. A literature search was performed in Medline, Embase, Web of Science and Scopus, as well as grey literature. Keywords such as “COVID‐19” and “Proton Therapy” were used. Articles published from 1 January 2020 in English were included. In total, 138 studies were identified of which 11 articles met the inclusion criteria. A scoping review design was chosen to capture the full extent of information published relating to the aim. Six of 11 articles included statements regarding treatment of COVID‐19 patients. Three publications recommended deferred or alternative treatment, two indicated to treat urgent/emergency patients and one reported continuous treatment for infectious patients. Recurring impacts on PT provision included more frequent use of unconventional therapies, reduced referrals, delayed treatment starts and CT simulation, change in treatment target volumes and staffing limitations due to pandemic restrictions. Consequently, telehealth consults, remote work, reduction in patient visitors, screening procedures and rigorous cleaning protocols were recommended. Few publications detailed changes to patient selection or workflow methods during the pandemic. Further research is needed to obtain more detailed information regarding current global patient selection methods in PT, collecting this data could aid in future planning for PT in Australia.

Background/Aim The aim of this study was to compare the therapeutic efficacy of ablation and surgery in solitary hepatocellular carcinoma (HCC) measuring ≤5 cm with a large HCC cohort database. Methods The study included consecutive 2,067 patients with solitary HCC who were treated with either ablation (n=1,248) or surgery (n=819). Th e patients were divided into three groups based on the tumor size and compared the outcomes of the two therapies using propensity score matching. Results No significant difference in recurrence-free survival (RFS) or overall survival (OS) was found between surgery and ablation groups for tumors measuring ≤2 cm or >2 cm but ≤3 cm. For tumors measuring >3 cm but ≤5 cm, RFS was significantly better with surgery than with ablation (3.6 and 2.0 years, respectively, P=0.0297). However, no significant difference in OS was found between surgery and ablation in this group (6.7 and 6.0 years, respectively, P=0.668). Conclusion The study suggests that surgery and ablation can be equally used as a treatment for solitary HCC no more than 3 cm in diameter. For HCCs measuring 3-5 cm, the OS was not different between therapies; thus, ablation and less invasive therapy can be considered a treatment option; however, special caution should be taken to prevent recurrence.

Background: "Disulfide death," a form of cellular demise, is triggered by the abnormal accumulation of intracellular disulfides under conditions of glucose deprivation. However, its role in the prognosis of glioma remains undetermined. Therefore, the main objective of this study is to establish prognostic signature based on disulfide death-related genes (DDRGs) and to provide new solutions in choosing the effective treatment of glioma. Methods: The RNA transcriptome, clinical information, and mutation data of glioma samples were sourced from The Cancer Genome Atlas (TCGA) and the Chinese Glioma Genome Atlas (CGGA), while normal samples were obtained from the Genotype-Tissue Expression (GTEx). DDRGs were compiled from previous studies and selected through differential analysis and univariate Cox regression analysis. The molecular subtypes were determined through consensus clustering analysis. Further, LASSO analysis was employed to select characteristic genes, and subsequently, a risk model comprising seven DDRGs was constructed based on multivariable Cox analysis. Kaplan-Meier survival curves were employed to assess survival differences between high and low-risk groups. Additionally, functional analyses (GO, KEGG, GSEA) were conducted to explore the potential biological functions and signaling pathways of genes associated with the model. The study also explored immune checkpoint (ICP) genes, immune cell infiltration levels, and immune stromal scores. Finally, the effect of Importin-4(IPO4) on glioma has been further confirmed through RT-qPCR, Western blot, and cell functional experiments. Results: 7 genes associated with disulfide death were obtained and two subgroups of patients with different prognosis and clinical characteristics were identified. Risk signature was subsequently developed and proved to serve as an prognostic predictor. Notably, the high-risk group exhibited an immunosuppressive microenvironment characterized by a high concentration of M2 macrophages and regulatory T cells (Tregs). In contrast, the low-risk group showed lower half-maximal inhibitory concentration (IC50) values. Therefore, patients in the high-risk group may benefit more from immunotherapy, while patients in the low-risk group may benefit more from chemotherapy. In addition, in vitro experiments have shown that inhibition of the expression of IPO4 leads to a significant reduction in the proliferation, migration, and invasion of glioma cells. Conclusion: This study identified two glioma subtypes and constructed a prognostic signature based on DDRGs. The signature has the potential to optimize the selection of patients for immune- and chemotherapy and provided a potential therapeutic target for glioma. [ABSTRACT FROM AUTHOR]

Purpose: We searched for perioperative renal function deterioration risk factors in patients that underwent bilateral flexible ureteroscopy (fURS) for kidney stones. Methods: From August 2016 to February 2020, symptomatic patients > 18 years old with bilateral kidney stones up to 20 mm in each side were prospectively studied. Serum creatinine samples were collected on admission to surgery, immediate postoperative (IPO), on POD 3, 10, and 30. Estimated glomerular filtration rate (eGFR) was calculated using Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) without a race coefficient. Results: Thirty patients underwent bilateral fURS. Comparing to preoperative eGFR, median IPO and POD3 eGFR (p < 0.001) were significantly lower, and POD10 (p = 0.092) and POD30 (p = 0.648) were similar to preoperative eGFR. During follow-up, 22/30 (73.3%), 14/30 (46.7%), and 7/30 (23.3%) of the patients presented a decrease > 10% eGFR, > 20% eGFR, and > 30% eGFR, respectively. Multivariate analysis demonstrated that lower preoperative eGFR is a risk factor for eGFR < 60 mL/min/1.73 m2, p = 0.019 [1.021–1.263; 1.136]; ASA > 1 is a risk factor for decrease of eGFR > 10%, p = 0.028 [1.25–51.13; 8.00]; longer operative time is a risk factor for decrease of eGFR > 20%, p = 0.042 [1.00–1.05; 1.028]; and operative time ≥ 120 min is a risk factor for decrease of eGFR > 30%, p = 0.026 [0.016–0.773; 0.113]. Conclusions: Renal function suffers a reversible decrease after bilateral fURS. Our study suggests that adequate selection of patients and maintaining operative time < 120 min are relevant factors in preventing acute renal function deterioration following bilateral fURS. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To curb rising trend of cesarean births: Implementing C-section audit at facility level is one of the effective non clinical interventions to curb the rising trend of cesarean births and forms an integral part of LaQshya initiative. Operationalization of C Section audit and implementing corrective & preventive actions for ensuring that C' Sections arc undertaken judiciously in those cases having robust clinical indications forms one of the key process interventions under LaQshya AIM To audit cesarean sections using robsons ten group classification system. METHODOLOGY: This retrospective study was conducted for 5months from January to June 2023, in Department of OBG, King George Hospital, Visakhapatnam. Data of patients who delivered by CS during this period were recorded and categorized in the 10 groups of TGCS. The size of each group, CS rate, and contribution of each group toward overall CS were calculated. RESULT Total number of deliveries were 2185 during the study period, of which c section was done in 1350 deliveries with a caesarean rate of 61.78% in our institute. In our study group 5 was the major contributor to the overall caesarean section rate followed by group 2 and 1. Primary CS rate is higher than the repeat CS rate. Increasing trend in caesarean section rate is observed in group 1, 2 and 5. In order to reduce CS rate among group 2 better patient selection for induction of labor based on Bishop Score. To reduce CS rate among group 5 more TOLACs has to be encouraged. [ABSTRACT FROM AUTHOR]

Introduction: The importance of identifying how patients choose their healthcare providers has grown with the prevalence of consumer-centric health insurance plans. There is currently a lack of studies exploring the factors associated with how patients select their hip and knee joint arthroplasty surgeons. The purpose of this study was to determine how patients find their arthroplasty providers and the relative importance of various arthroplasty surgeon characteristics. Methods: An electronic mail survey was sent to 3522 patients who had visited our institution for an arthroplasty surgeon office visit between August 2022 and January 2023. The survey consisted of multiple-choice questions, which aimed to inquire about the patients' referral sources for their current arthroplasty surgeon. In addition, patients were requested to rate the significance of 22 surgeon-related factors, on a scale of 1 (Not Important At All) to 5 (Very Important), in choosing their arthroplasty surgeon. Results: Of the 3522 patients that received the survey, 538 patients responded (15.3%). The most common referral sources were physician referral (50.2%), family/friend referral (27.7%), and self-guided research (24.5%). Of those that were referred by a physician, 54.4% of respondents were referred by another orthopaedic provider. Patients rated board certification (4.72 ± 0.65), in-network insurance status (4.66 ± 0.71), fellowship training (4.50 ± 0.81), bedside manner/personality (4.32 ± 0.86), and facility appearance (4.26 ± 0.81) as the five most important factors in picking an arthroplasty surgeon. Television (1.42 ± 0.83), print (1.50 ± 0.88), and online (1.58 ± 0.93) advertisements, along with social media presence (1.83 ± 1.08), and practice group size (2.97 ± 1.13) were rated as the five least important factors. Conclusion: Patients are most likely to select an arthroplasty surgeon based on referral from other physicians, namely orthopedic surgeons, in addition to board certification status, in-network insurance, and fellowship training. Overall, these findings highlight the importance of physician credentials and reputation within the orthopaedic community in order to attract and retain patients. [ABSTRACT FROM AUTHOR]

Background: Patients undergoing total hip arthroplasty (THA) with the direct anterior approach (DAA) may experience faster recovery but may also have better baseline health than those who undergo THA with the posterior approach (PA). This study aimed to compare patient-reported outcome measures (PROMs) between the DAA and PA while controlling for baseline factors. Methods: This is a secondary data analysis from a prospective cohort study of patients utilizing a smartphone-based care management platform following THA. The primary outcomes were HOOS JR and EQ-5D-5L through 1 year and change from baseline. Longitudinal regression models were created to control for baseline characteristics and investigate the impact of surgical approach on PROMs. Results: Of 1364 THAs evaluated, 731 (53.6%) were female, and 840 (61.6%) used the PA. Patients in the PA group were of similar age but had higher body mass index and comorbidity scores. Pre-operative HOOS JR and EQ-5D-5L were comparable, but higher post-operatively in the DAA group through 6 months (p = 0.03 and p = 0.005). At 1 year post-operatively, HOOS JR and EQ-5D-5L did not vary between groups (p = 0.48 and p = 0.56), nor did changes from baseline (p = 0.47 and p = 0.11). After controlling baseline characteristics, DAA was significantly associated with higher average HOOS JR through 6 months (p = 0.03) and EQ-5D-5L through 3 months (p = 0.005), but not at 12 months (p = 0.89 and p = 0.56). Conclusion: THA patients undergoing DAA demonstrate earlier improvements in HOOS JR and EQ-5D-5L. However, these differences may not be clinically significant and are not evident at 1-year post-operative. Patient selection and surgeon training may continue to affect outcomes by surgical approach. [ABSTRACT FROM AUTHOR]

Simple Summary: Breast cancer is known to be associated with the race and ethnicity of patients regarding the tumor characteristics and patient survival. However, in worldwide clinical trials, the participation of Black and Hispanic patients is lower than expected based on the frequency of breast cancer in these populations. This article aims to assess race reporting and representation trends in European trials. Ninety-seven such trials conducted exclusively in Europe between 2010 and 2022 were identified in the PubMed and ClinicalTrials.gov databases. Race was reported in 10.31% of these, and mostly in trials carried out across multiple European countries. They featured a White-predominant population, with 1.08% Asian and 0.88% Black patients included. Race reporting trends in European trials are much lower than in worldwide or American-based trials on the same subject. Systematic race reporting among other patient demographics and adequate minority inclusion will ameliorate the quality of European clinical trials and promote equality in healthcare access. Breast cancer is the most prevalent female cancer worldwide with known correlations between the race and tumor characteristics of the patients and prognosis. International and US-based studies, however, have reported a disproportionate representation of Black and Hispanic patients in clinical trials. This is the first study assessing race and ethnicity reporting trends and inclusion in European breast cancer trials. The PubMed and ClinicalTrials.gov databases were systematically searched for trials on breast cancer treatment conducted exclusively in Europe between 2010 and 2022. Of the 97 identified trials, race was reported in 10.31%. Multinational participation, but not the study size or trial phase, was significantly associated with higher race reporting trends. These 10 trials featured a White-predominant population, with 1.08% Asian and 0.88% Black patients included. The acquisition of the race and ethnicity data of patients in European trials is lower compared to the U.S. or worldwide studies and does not permit extensive analysis of minority participation. In a limited analysis, the low rates of minority participation are concerning, based on population-based data on minorities in select European countries. These observations should encourage race reporting practices in European breast cancer trials and adequate minority participation to support the generalizability of the results of the studies and promote healthcare equity. [ABSTRACT FROM AUTHOR]

Simple Summary: Pancreatic cancer presents a challenge due to its high mortality rates and limited treatment options. In an effort to improve patient outcomes, neoadjuvant treatment (NAT) has emerged as a promising approach for both resectable and borderline resectable pancreatic cancer. This scoping review provides a comprehensive overview of evidence from published (n = 14) and ongoing (n = 12) randomized Phase II and III trials, shedding light on the current status of NAT. The efficacy of NAT in terms of survival benefits for patients with resectable pancreatic cancer has been still controversial. However, the efficacy of NAT has been affirmed in cases of borderline resectable pancreatic cancer, although the ideal treatment regimens remain subject to debate. Ongoing trials are actively exploring novel approaches, including immunotherapy, underscoring the dynamic nature of pancreatic cancer treatment. Future efforts aim to refine treatment strategies by integrating systemic chemotherapy with immunotherapy, guided by molecular-based biomarkers to achieve precision oncology. Pancreatic cancer (PC) is a lethal disease that requires innovative therapeutic approaches to enhance the survival outcomes. Neoadjuvant treatment (NAT) has gained attention for resectable and borderline resectable PC, offering improved resection rates and enabling early intervention and patient selection. Several retrospective studies have validated its efficacy. However, previous studies have lacked intention-to-treat analyses and appropriate resectability classifications. Randomized comparative trials may help to enhance the clinical applicability of evidence. Therefore, after searching the MEDLINE database, this scoping review presents a comprehensive summary of the evidence from published (n = 14) and ongoing (n = 12) randomized Phase II and III trials. Diverse regimens and their outcomes were explored for both resectable and borderline resectable PC. While some trials have supported the efficacy of NAT, others have demonstrated no clear survival benefits for patients with resectable PC. The utility of NAT has been confirmed in patients with borderline resectable PC, but the optimal regimens remain debatable. Ongoing trials are investigating novel regimens, including immunotherapy, thereby highlighting the dynamic landscape of PC treatment. Studies should focus on biomarker identification, which may enable precision in oncology. Future endeavors aim to refine treatment strategies, guided by precision oncology. [ABSTRACT FROM AUTHOR]

This article explores the relationship between red blood cell (RBC) senescence and vascular function in patients with hereditary spherocytosis (HS), a condition characterized by abnormal RBC structure. The study compares HS patients with and without splenectomy to a control group, examining vascular function, RBC rheology, and RBC senescence markers. The findings suggest that splenectomy may be associated with an increased risk of vascular events in HS patients. The study provides valuable insights into the pathophysiology of HS and its impact on vascular health. [Extracted from the article]

Background: Coronary bifurcation lesions are commonly encountered during coronary angiography. The management of bifurcation lesions remains challenging, with various bifurcation techniques being available and outcomes varying depending on the Medina classification and operator experience. Methods: We present a short case series and the outcomes of a new bifurcation technique for the management of simple Medina '0,0,1' and '0,0,1' bifurcation lesions using the kissing balloon-stent technique (kissing BS). Results: We retrospectively identified 8 patients who underwent bifurcation stenting using the kissing Balloon-Stent technique, along with their clinical and angiographic follow-up outcomes. We also describe the benefits and limitations of the technique, delineate the potential mechanisms of target lesion failure, and outline appropriate patient selection. Conclusions: Kissing Balloon-Stent technique is a simple single stent technique that is safe and feasible in select patients with Medina '0,0,1' and '0,0,1' bifurcation lesions. [ABSTRACT FROM AUTHOR]

Background: In the era of modern medicine, where high‐throughput sequencing techniques are readily available, it is desirable to elucidate the role of genetic background in patients with Parkinson's Disease (PD) undergoing Deep Brain Stimulation (DBS). Genetic stratification of PD patients undergoing DBS may assist in patient selection and prediction of clinical outcomes and complement existing selection procedures such as levodopa challenge testing. Objective: To capture a broad spectrum of motor and non‐motor DBS outcomes in genetic PD patients with data from the recently updated literature. Methods: A multi‐scale meta‐analysis with 380 genetic PD cases was conducted using the Cochrane Review Manager, JASP software and R. Results: This meta‐analysis revealed that overall, patients with genetic PD are good candidates for DBS but the outcomes might differ depending on the presence of specific mutations. PRKN carriers benefited the most regarding motor function, daily dose medication and motor complications. However, GBA carriers appeared to be more prone to cognitive decline after subthalamic nucleus DBS accompanied by a low quality of life with variable severity depending on genetic variants and concomitant alterations in other genes. Apart from GBA, cognitive worsening was also observed in SNCA carriers. Pre‐operative levodopa responsiveness and a younger age of onset are associated with a favorable motor outcome. Conclusion: A personalized approach with a variant‐based risk stratification within the emerging field of surgicogenomics is needed. Integration of polygenic risk scores in clinical‐decision making should be encouraged. [ABSTRACT FROM AUTHOR]

Chimeric antigen receptor T cell (CAR-T) therapy, an innovative immune cell therapy, has revolutionized the treatment landscape of haematological malignancies. The past 2 years has witnessed the successful application of CD19-targeting CAR constructs in refractory cases of autoimmune rheumatic diseases, including systemic lupus erythematosus, systemic sclerosis and anti-synthetase syndrome. In comparison with existing B cell depletion therapies, targeting CD19 has demonstrated a more rapid and profound therapeutic effect, enabling drug-free remission with manageable adverse events. These promising results necessitate validation through long-term, large-sample randomized controlled studies. Corroborating the role of CAR-T therapy in refractory rheumatological disorders and affirming safety, efficacy and durability of responses are the aims of future clinical studies. Optimizing the engineering strategies and better patient selection are also critical to further refining the successful clinical implementation of CAR-T therapy. [ABSTRACT FROM AUTHOR]

Background: Distressing symptoms are common in advanced cancer. Medicinal cannabinoids are commonly prescribed for a variety of symptoms. There is little evidence to support their use for most indications in palliative care. This study aims to assess a 1:20 delta-9-tetrahydrocannabinol/cannabidiol (THC/CBD) cannabinoid preparation in the management of symptom distress in patients with advanced cancer undergoing palliative care. Methods and design: One hundred and fifty participants will be recruited across multiple sites in Queensland, Australia. A teletrial model will facilitate the recruitment of patients outside of major metropolitan areas. The study is a pragmatic, multicenter, randomised, placebo-controlled, two-arm trial of escalating doses of an oral 1:20 THC/CBD medicinal cannabinoid preparation (10 mg THC:200 mg CBD/mL). It will compare the efficacy and safety outcomes of a titrated dose range of 2.5 mg THC/50mgCBD to 30 mg THC/600 mg CBD per day against a placebo. There is a 2-week patient-determined titration phase, to reach a dose that achieves symptom relief or intolerable side effects, with a further 2 weeks of assessment on the final dose. The primary objective is to assess the effect of escalating doses of a 1:20 THC/CBD medicinal cannabinoid preparation against placebo on change in total symptom distress score, with secondary objectives including establishing a patient-determined effective dose, the effect on sleep quality and overall quality of life. Some patients will be enrolled in a sub-study which will more rigorously evaluate the effect on sleep. Discussion: MedCan-3 is a high-quality, adequately powered, placebo-controlled trial which will help demonstrate the utility of a THC:CBD 1:20 oral medicinal cannabis product in reducing total symptom distress in this population. Secondary outcomes may lead to new hypotheses regarding medicinal cannabis' role in particular symptoms or in particular cancers. The sleep sub-study will test the feasibility of using actigraphy and the Insomnia Severity Index (ISI) in this cohort. This will be the first large-scale palliative care randomised clinical trial to utilise the teletrial model in Australia. If successful, this will have significant implications for trial access for rural and remote patients in Australia and internationally. Trial registration: ANZCTR ACTRN12622000083796. Protocol number 001/20. Registered on 21 January 2022. Recruitment started on 8 August 2022. [ABSTRACT FROM AUTHOR]

This qualitative study was informed by critical race feminism and sought to examine Canadian Black women's motivations for participating in the research study that explored their experiences with the police in the context of intimate partner violence (IPV), and the key factors that complicated their decisions. Semistructured interviews were conducted with 25 self-identified women over the age of 18. Findings indicated that Black women's experiences of anti-Black racism and various forms of systemic barriers influenced their decisions to disclose their experiences of IPV. Key themes included the invisibility of Black women's narratives, fostering political change, and the impact of racialized and gendered insider positionality. Given these findings, positioning Black women's narratives at the centre of IPV research creates opportunities for Black women to share their experiences of IPV, recognizes them as experts of their own experiences, identifies their differential experiences accessing services and supports and the barriers that impact their participation in research studies. The study provides strategies on how to increase Black women's participation and engagement in IPV research. [ABSTRACT FROM AUTHOR]

Purpose: To review our experience with >100 patients with primary obstructive megaureter (POM) undergoing endoscopic balloon dilatation (EBD) and a follow-up of up to 12 years and determine potential risk factors for failure. Our hypothesis is that EBD allows for long-term treatment in >80% of patients, and its effectiveness decreases in more severe cases. Methods: This is a retrospective study of 123 consecutive patients (131 ureters) undergoing EBD from 2009 to 2021. Indications for EBD included symptoms, worsening dilatation, and/or renal function impairment. Clinical characteristics, complications, and outcomes, including those in the patients with >5-year follow-up, were described. Preoperative and intraoperative markers of severity chosen a priori were tested as risk factors for failure. Failure was defined as the need for ureteral reimplantation after EBD. Results: EBD was feasible in 121 of 123 (98%) patients, regardless of age. After a median follow-up of 38 (9–143) months, EBD was effective in 84.5% of cases. Failures generally occurred in the 1st year after EBD and were seldom associated with permanent loss of renal function. Of the 66 patients with follow-up >5 years, EBD was effective in 56 patients. No preoperative characteristic proved to be a risk factor for failure. The intraoperative absence of a ring was the only significant risk factor for failure, odd ratio 117.86 (95% confidence interval 6.27–2215.84). Conclusions: EBD was feasible and definitive treatment in 85% of our cases, regardless of age. Since this study did not identify preoperative factors to help the clinicians in patient selection, we consider EBD a viable initial procedure in all patients with POM who require surgical intervention, especially in infants. [ABSTRACT FROM AUTHOR]

Background: Cone beam computed tomography (CBCT) enables intraoperative cross-sectional and three-dimensional imaging of the urinary tract. CBCT in a hybrid operating room can be used for intraoperative detection of residual stones and potential additional stone extraction at the end of percutaneous nephrolithotomy (PCNL). This study describes our initial experience with intraoperative CBCT during PCNL and analyzes its role in potentially improving its outcomes. Methods: We conducted a single-center retrospective cohort study at a tertiary referral hospital between 2018 and 2021. The study aimed to evaluate the outcome of patients who underwent intraoperative noncontrast CBCT scan during PCNL. The CBCT scan was performed when the urologist determined the kidney to be endoscopically stone-free. In case any residual fragments were imaged, an additional effort was made to extract them. Patients were divided into three groups based on treatment outcome: stone-free upon CBCT, not stone-free with additional stone extraction after CBCT, and not stone-free without additional stone extraction. Procedure and patient characteristics were recorded to identify factors associated with additional stone extraction during CBCT-assisted PCNL. Results: A total of 102 procedures were included in this study. Intraoperative CBCT scans showed residual calcifications in 58 (57%) cases. In 39 cases, which is 38% of the total population and 61% of the cases with residual calcifications, one or more residual fragments imaged on the intraoperative CBCT-scan were extracted additionally within the same procedure. A higher Guy's Stone Score was associated with a higher likelihood of additionally extracting stones as a result of the CBCT. Conclusions: CBCT-assisted PCNL in a hybrid operating room can lead to additional stone extraction in the same procedure in 37% of all cases and in over 60% of the cases in which residual fragments are imaged. The value of CBCT-assisted PCNL appears to increase in the case of more complex stone surgery cases. [ABSTRACT FROM AUTHOR]

Editor's note: This is the 21st article in a series on clinical research by nurses. The series is designed to be used as a resource for nurses to understand the concepts and principles essential to research. Each column will present the concepts that underpin evidence-based practice—from research design to data interpretation. To see all the articles in the series, go to https://links.lww.com/AJN/A204. This article, one in a series on clinical research by nurses, focuses on study implementation: gathering essential resources such as space, funding, and personnel; managing the budget process; and finalizing protocols and standard operating procedures. [ABSTRACT FROM AUTHOR]

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee that includes multiple cycles but offers a partial or complete refund if treatment fails. This opinion of the American Society for Reproductive Medicine Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient-informed consent. This document replaces the document of the same name, last published in 2016. [ABSTRACT FROM AUTHOR]

The article presents the discussion on contemplating the first whole eye transplant (WET) procedure in humans. Topics include implications of such a procedure on the physical, social, and psychological well-being of the patient, and focus on the need for transparency, information-sharing; and authors acknowledge the tension between the medical and social models of disability.

As innovations in the field of vascular composite allotransplantation (VCA) progress, whole-eye transplantation (WET) is poised to transition from non-human mammalian models to living human recipients. Present treatment options for vision loss are generally considered suboptimal, and attendant concerns ranging from aesthetics and prosthesis maintenance to social stigma may be mitigated by WET. Potential benefits to WET recipients may also include partial vision restoration, psychosocial benefits related to identity and social integration, improvements in physical comfort and function, and reduced surgical risk associated with a biologic eye compared to a prosthesis. Perioperative and postoperative risks of WET are expected to be comparable to those of facial transplantation (FT), and may be similarly mitigated by immunosuppressive protocols, adequate psychosocial support, and a thorough selection process for both the recipient and donor. To minimize the risks associated with immunosuppressive medications, the first attempts in human recipients will likely be performed in conjunction with a FT. If first-in-human attempts at combined FT-WET prove successful and the biologic eye survives, this opens the door for further advancement in the field of vision restoration by means of a viable surgical option. This analysis integrates recent innovations in WET research with the existing discourse on the ethics of surgical innovation and offers preliminary guidance to VCA programs considering undertaking WET in human recipients. [ABSTRACT FROM AUTHOR]

Background: Adolescents with mild‐to‐borderline intellectual disability face peer resistance challenges, risking harmful or dangerous situations. Method: We designed a peer resistance group intervention at school for adolescents with mild‐to‐borderline intellectual disability, tested its feasibility (N = 4, Mage = 14.1, MIQ = 78.8), adapted it, and tested it again (N = 6, Mage = 15.0, MIQ = 72.8). Results: Study 1 demonstrated feasibility in recruitment, resources, and potential benefits on the distal outcome risk taking. However, attendance, obtained knowledge, and potential benefits on peer resistance, peer problems, and prosocial behaviour were suboptimal. Consequently, study 2 contained more learning by doing and individual lessons, resulting in higher attendance and greater personalization. While potential benefits on improved peer resistance measures were not observed, risk taking improved. Conclusions: Despite finding no potential benefits on peer resistance, running a peer resistance intervention for adolescents with mild‐to‐borderline intellectual disability at school is considered feasible. [ABSTRACT FROM AUTHOR]

The more than 600 Area Agencies on Aging (AAAs) throughout the U.S. are as diverse as the communities they serve, making it challenging to establish indicators of success that are not simply compliance-focused. This study builds agreement among AAAs to identify impactful, feasible, and measurable indicators of success. A mixed methods study was conducted with two surveys of AAA experts to identify indicators of success; assessments of those indicators' impact, feasibility, and measurability; and virtual focus groups to interpret findings. Most indicators that had the potential for high impact received low feasibility and measurability scores. AAAs want more technical assistance, funding, and staffing resources from their states and the Administration on Aging to make data collection and analysis less burdensome and more outcome-oriented. State Units on Aging and the Administration on Aging can use the study findings to improve assessments of AAAs without placing undue burdens on staff attempting to demonstrate their impact. This study can help to identify future priorities regarding AAA assessments and innovations. [ABSTRACT FROM AUTHOR]

Purpose: The prevalence of metastatic epidural spinal cord compression (MESCC) is increasing globally due to advancements in cancer diagnosis and treatment. Whilst surgery can benefit specific patients, the complication rate can reach up to 34%, with limited reporting on their impact in the literature. This study aims to analyse the influence of major complications on the survival of surgically treated MESCC patients. Methods: Consecutive MESCC patients undergoing surgery and meeting inclusion criteria were selected. Survival duration from decompressive surgery to death was recorded. Perioperative factors influencing survival were documented and analysed. Kaplan–Meier survival analysis at one year compared these factors. Univariate and multivariate Cox proportional hazard regression analyses were performed. Additionally, univariate analysis compared complicated and uncomplicated groups. Results: Seventy-five patients were analysed. Median survival for this cohort was 229 days (95% CI 174–365). Surgical complications, low patient performance, and rapid primary tumour growth were significant perioperative variables for survival in multivariate analyses (p < 0.001, p = 0.003, and p = 0.02, respectively) with a hazard ratio of 3.2, 3.6, and 2.1, respectively. Univariate analysis showed no variables associated with complication occurrence. Conclusion: In this cohort, major surgical complications, patient performance, and primary tumour growth rate were found to be independent factors affecting one year survival. Thus, prioritizing complication prevention and appropriate patient selection is crucial for optimizing survival in this population. [ABSTRACT FROM AUTHOR]

Transitional age youth experiencing homelessness (TAY-EH) represent an underserved and understudied population. While an increasing number of empirical interventions have sought to address the high burden of psychopathology in this population, findings remain mixed regarding intervention effectiveness. In this systematic review of behavioral health interventions for TAY-EH, we sought to examine the structural framework in which these interventions take place and how these structures include or exclude certain populations of youth. We also examined implementation practices to identify how interventions involving youth and community stakeholders effectively engage these populations. Based on PRISMA guidelines, searches of Medline, PsycInfo, Embase, Cochrane Central, Web of Science, and ClinicalTrials.gov databases were conducted, including English language literature published before October 2022. Eligible studies reported on interventions for adolescent or young adult populations ages 13–25 years experiencing homelessness. The initial search yielded 3850 citations; 353 underwent full text review and 48 met inclusion criteria, of which there were 33 unique studies. Studies revealed a need for greater geographic distribution of empirically based interventions, as well as interventions targeting TAY-EH in rural settings. Studies varied greatly regarding their operationalizations of homelessness and their method of intervention implementation, but generally indicated a need for increased direct-street outreach in participant recruitment and improved incorporation of youth feedback into intervention design. To our knowledge, this is the first systematic review to examine the representation of various groups of TAY-EH in the literature on substance use and mental health interventions. Further intervention research engaging youth from various geographic locations and youth experiencing different forms of homelessness is needed to better address the behavioral health needs of a variety of TAY-EH. [ABSTRACT FROM AUTHOR]

General population studies find that rates of child maltreatment are higher than those identified in the child welfare system. Some modes of administration may result in higher disclosure rates of child maltreatment by respondents. This study assesses differences in characteristics of parents who are recruited using telephone sampling techniques or via the internet and whether the survey was administered by telephone or the web. We have 1599 parent respondents recruited from listed samples and Craigslist advertisements. Surveys were administered via the telephone or online. Survey included measures of parenting behaviours, psychosocial characteristics and demographics for the parent, child and family. Data were analysed using logit multilevel models. We found no differences between mode of administration and our child maltreatment and parenting measures, including physical abuse, corporal punishment and supervisory neglect. Recruitment strategy was not related to leaving a child home alone and corporal punishment. However, we did find that parents recruited by Craigslist use physical abuse more frequently. That we found no difference in use of punitive and neglectful parenting practices by survey mode of administration and recruitment method provides some degree of confidence that survey methods other than random‐digit‐dialling telephone surveys may result in generalizable samples in this age of declining landline use. [ABSTRACT FROM AUTHOR]

Objective: The relative merits of inpatient or day‐treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non‐inferiority of a stepped‐care day patient treatment (DPT) approach versus inpatient treatment as usual (IP‐TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure. Method: Fifteen patients with AN (of 53 approached) participated and were followed‐up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis. Results: At baseline, participants in both trial arms rated stepped‐care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (n = 12/38). Conclusions: No conclusions can be drawn concerning the effectiveness of IP‐TAU and stepped‐care DPT, but the latter was perceived more positively. Patient‐related, service‐related and systemic factors (COVID‐19) contributed to the trial's failure. Lessons learnt can inform future studies. Highlights: Patient‐related (e.g., treatment preferences) and service‐related (e.g., reduced service capacity) alongside wider systemic (e.g., increased emergency admissions due to COVID‐19) factors seem to have contributed to the failure of the DAISIES trial.Patients and carers identified valued aspects for both inpatient (e.g., weight gain) and day‐patient (e.g., greater link to home environment) treatment settings, but day‐patient treatment was perceived as a more holistic and collaborative approach, and thus as more positive.Although randomised controlled studies investigating intensive treatments for severe anorexia nervosa are important and necessary, alternative study designs should be explored to overcome implementation challenges. [ABSTRACT FROM AUTHOR]

Background: Outcomes of trauma "walk-in" patients (using private vehicles or on foot) are understudied. We compared outcomes of ground ambulance vs walk-ins, hypothesizing that delayed resuscitation and uncoordinated care may worsen walk-in outcomes. Methods: A retrospective analysis 2020 American College of Surgeons Trauma Quality Programs (ACS-TQP) databases compared outcomes between ambulance vs "walk-ins." The primary outcome was in-hospital mortality, excluding external facility transfers and air transports. Data was analyzed with descriptive statistics, bivariate, multivariable logistic regression, including an Inverse Probability Weighted Regression Adjustment with adjustments for injury severity and vital signs. The primary outcome for the 2019 (pre-COVID-19 pandemic) data was similarly analyzed. Results: In 2020, 707,899 patients were analyzed, 556,361 (78.59%) used ambulance, and 151,538 (21.41%) were walk-ins. We observed differences in demographics, hospital attributes, medical comorbidities, and injury mechanism. Ambulance patients had more chronic conditions and severe injuries. Walk-ins had lower in-hospital mortality (850 (.56%) vs 23,131 (4.16%)) and arrived with better vital signs. Multivariable logistic regression models (inverse probability weighting for regression adjustment), adjusting for injury severity, demographics, injury mechanism, and vital signs, confirmed that walk-in status had lower odds of mortality. For the 2019 (pre-COVID-19 pandemic) database, walk-ins also had lower in-hospital mortality. Discussion: Our results demonstrate better survival rates for walk-ins before and during COVID-19 pandemic. Despite limitations of patient selection bias, this study highlights the need for further research into transportation modes, geographic and socioeconomic factors affecting patient transport, and tailoring management strategies based on their mode of arrival. [ABSTRACT FROM AUTHOR]

Background: Post‐operative diarrhoea is a common adverse event after pancreatic surgery. While the risk factors for this condition have been identified, the increasing trend of administering chemotherapy before surgery might change these factors. This study aimed to identify the risk factors of post‐operative diarrhoea in patients with pancreatic ductal adenocarcinoma (PDAC) who underwent neoadjuvant chemotherapy. Design: A retrospective cohort study. Methods: Patients who underwent neoadjuvant chemotherapy and pancreatectomy because of PDAC between 2021 and 2023 were included. The preoperative characteristics of, operative details of and post‐operative outcomes in patients with and without post‐operative diarrhoea were collected and compared. The independent risk factors of post‐operative diarrhoea were identified using logistic regression analysis. STROBE checklist was used. Results: Post‐operative diarrhoea occurred in 65 out of 145 (44.8%) patients during hospitalization. Elevated white blood cell count, advanced tumour stage, and late abdominal drain removal were independent risk factors for post‐operative diarrhoea (p <.001, p =.006 and p =.009, respectively). Conclusions: Some perioperative factors influence post‐operative diarrhoea in patients who undergo neoadjuvant chemotherapy. More attention should be paid to patients at a higher risk of post‐operative diarrhoea, with an emphasis on high‐quality management for these patients. [ABSTRACT FROM AUTHOR]

Background: Imaging-based assessment of sarcopenia is a well-validated prognostic tool for patients with chronic liver disease. However, little is known about its value in patients with primary sclerosing cholangitis (PSC). This cross-sectional study aimed to investigate the predictive value of the cross-sectional imaging-based skeletal muscle index (SMI) for transplant-free survival (TFS) in patients with PSC. Methods: A total of 95 patients with PSC who underwent abdominal cross-sectional imaging between 2008 and 2022 were included in this retrospective study. SMI was measured at the third lumbar vertebra level (L3-SMI). The cut-off values to define sarcopenia were < 50 cm²/m² in male patients and < 39 cm²/m² in female patients. The primary outcome of this study was TFS, which was defined as survival without liver transplantation or death from any cause. Results: Our study indicates that L3-SMI sarcopenia impairs TFS in patients with PSC (5-year TFS: 33.9% vs. 83.3%, p = 0.001, log-rank test). L3-SMI sarcopenia was independently associated with reduced TFS via multivariate Cox regression analysis (HR = 2.749; p = 0.028). Body mass index reduction > 10% at 12 months, which is used as MELD standard exception (SE) criterion in Eurotransplant (in Germany only until September 2023), was not significantly associated with TFS in the multivariate Cox regression analysis (HR = 1.417; p = 0.330). Substitution of BMI reduction with L3-SMI in the German SE criteria improved the predictive accuracy of TFS compared to the established SE criteria (multivariable Cox regression analysis: HR = 4.007, p < 0.001 vs. HR = 1.691, p = 0.141). Conclusion: Imaging-based diagnosis of sarcopenia via L3-SMI is associated with a low TFS in patients with PSC and may provide additional benefits as a prognostic factor in patient selection for liver transplantation. [ABSTRACT FROM AUTHOR]

Background: Immunotherapy has emerged as a potent clinical approach for cancer treatment, but only subsets of cancer patients can benefit from it. Targeting lactate metabolism (LM) in tumor cells as a method to potentiate anti-tumor immune responses represents a promising therapeutic strategy. Methods: Public single-cell RNA-Seq (scRNA-seq) cohorts collected from patients who received immunotherapy were systematically gathered and scrutinized to delineate the association between LM and the immunotherapy response. A novel LM-related signature (LM.SIG) was formulated through an extensive examination of 40 pan-cancer scRNA-seq cohorts. Then, multiple machine learning (ML) algorithms were employed to validate the capacity of LM.SIG for immunotherapy response prediction and survival prognostication based on 8 immunotherapy transcriptomic cohorts and 30 The Cancer Genome Atlas (TCGA) pan-cancer datasets. Moreover, potential targets for immunotherapy were identified based on 17 CRISPR datasets and validated via in vivo and in vitro experiments. Results: The assessment of LM was confirmed to possess a substantial relationship with immunotherapy resistance in 2 immunotherapy scRNA-seq cohorts. Based on large-scale pan-cancer data, there exists a notably adverse correlation between LM.SIG and anti-tumor immunity as well as imbalance infiltration of immune cells, whereas a positive association was observed between LM.SIG and pro-tumorigenic signaling. Utilizing this signature, the ML model predicted immunotherapy response and prognosis with an AUC of 0.73/0.80 in validation sets and 0.70/0.87 in testing sets respectively. Notably, LM.SIG exhibited superior predictive performance across various cancers compared to published signatures. Subsequently, CRISPR screening identified LDHA as a pan-cancer biomarker for estimating immunotherapy response and survival probability which was further validated using immunohistochemistry (IHC) and spatial transcriptomics (ST) datasets. Furthermore, experiments demonstrated that LDHA deficiency in pancreatic cancer elevated the CD8+ T cell antitumor immunity and improved macrophage antitumoral polarization, which in turn enhanced the efficacy of immunotherapy. Conclusions: We unveiled the tight correlation between LM and resistance to immunotherapy and further established the pan-cancer LM.SIG, holds the potential to emerge as a competitive instrument for the selection of patients suitable for immunotherapy. [ABSTRACT FROM AUTHOR]

Objective: This systematic review aims to outline the use of population and disease registries for clinical trial pre-screening. Materials and methods: The search was conducted in the time period of January 2014 to December 2022 in three databases: MEDLINE, Embase, and Web of Science Core Collection. References were screened using the Rayyan software, firstly based on titles and abstracts only, and secondly through full text review. Quality of the included studies was assessed using the List of Included Studies and quality Assurance in Review tool, enabling inclusion of publications of only moderate to high quality. Results: The search originally identified 1430 citations, but only 24 studies were included, reporting the use of population and/or disease registries for trial pre-screening. Nine disease domains were represented, with 54% of studies using registries based in the USA, and 62.5% of the studies using national registries. Half of the studies reported usage for drug trials, and over 478,679 patients were identified through registries in this review. Main advantages of the pre-screening methodology were reduced financial burden and time reduction. Discussion and conclusion: The use of registries for trial pre-screening increases reproducibility of the pre-screening process across trials and sites, allowing for implementation and improvement of a quality assurance process. Pre-screening strategies seem under-reported, and we encourage more trials to use and describe their pre-screening processes, as there is a need for standardized methodological guidelines. [ABSTRACT FROM AUTHOR]

Objective: Endovascular repair is the preferred treatment for aortoiliac aneurysm, with preservation of at least one internal iliac artery recommended. This study aimed to assess pre-endovascular repair anatomical characteristics of aortoiliac aneurysm in patients from the Global Iliac Branch Study (GIBS, NCT05607277) to enhance selection criteria for iliac branch devices (IBD) and improve long-term outcomes. Methods: Pre-treatment CT scans of 297 GIBS patients undergoing endovascular aneurysm repair were analyzed. Measurements included total iliac artery length, common iliac artery length, tortuosity index, common iliac artery splay angle, internal iliac artery stenosis, calcification score, and diameters in the device's landing zone. Statistical tests assessed differences in anatomical measurements and IBD-mediated internal iliac artery preservation. Results: Left total iliac artery length was shorter than right (6.7 mm, P =.0019); right common iliac artery less tortuous (P =.0145). Males exhibited greater tortuosity in the left total iliac artery (P =.0475) and larger diameter in left internal iliac artery's landing zone (P =.0453). Preservation was more common on right (158 unilateral, 34 bilateral) than left (105 unilateral, 34 bilateral). There were 192 right-sided and 139 left-sided IBDs, with 318 IBDs in males and 13 in females. Conclusion: This study provides comprehensive pre-treatment iliac anatomy analysis in patients undergoing endovascular repair with IBDs, highlighting differences between sides and sexes. These findings could refine patient selection for IBD placement, potentially enhancing outcomes in aortoiliac aneurysm treatment. However, the limited number of females in the study underscores the need for further research to generalize findings across genders. [ABSTRACT FROM AUTHOR]

Aims: Embolic stroke of undetermined source (ESUS) accounts for up to 20% of ischemic strokes annually. Undetected atrial fibrillation (AF) is one important potential underlying cause. For AF, oral anticoagulation has evolved as the most preferable means of secondary stroke prevention. To detect unrecognized paroxysmal AF, long-term ECG monitoring is required, and implantable cardiac monitors (ICM) appear most suitable. Yet, ICMs are particularly costly, implantation is invasive, and remote monitoring places a personnel burden on health care providers. Here, we use data from a large cohort of ESUS patients to systematically analyze the effort of ICM remote monitoring for AF diagnosis and the strain on health care providers. Methods and results: From a prospective, single-center, observational ESUS registry, we analyzed all ICM-equipped patients post-ESUS (n = 172) between January 1st, 2018, and December 31st, 2019. Through January 2nd, 2023, 48 patients (27.9%) were diagnosed with AF by ICM remote monitoring. During follow-up, a total of 29,180 remote monitoring episodes were transmitted, of which 17,742 were alarms for AF. A systematic estimation of workload revealed that on average, 20.3 trained physician workhours are required to diagnose one patient with AF. Conclusion: ICM remote monitoring is useful to diagnose AF in cohort of post-ESUS patients. However, the number of ICM alarms is high, even in a cohort at known high risk of AF and in whom AF detection is therapeutically consequential. Improved automated event classification, clear recommendations for ICM interrogation after AF diagnosis, and a careful patient selection for ICM monitoring are warranted. [ABSTRACT FROM AUTHOR]

The introduction of minimally invasive surgery ushered in a new era of spine surgery by minimizing the undue iatrogenic injury, recovery time, and blood loss, among other complications, of traditional open procedures. Over time, technological advancements have further refined the care of the operative minimally invasive spine patient. Moreover, pre-, and postoperative care have also undergone significant change by way of artificial intelligence risk stratification, advanced imaging for surgical planning and patient selection, postoperative recovery pathways, and digital health solutions. Despite these advancements, challenges persist necessitating ongoing research and collaboration to further optimize patient care in minimally invasive spine surgery. [ABSTRACT FROM AUTHOR]

Simple Summary: Non-melanomatous cutaneous spindle cell neoplasms comprise a rare group of tumours, and in the advanced disease setting, a consensus on treatment approaches is lacking. These tumours are more common with age and have a propensity to develop in chronic ultraviolet (UV)-exposed sites. High response rates have been seen with immune-checkpoint inhibitors (ICI) in other UV-driven tumours such as cutaneous squamous cell carcinoma, yet these tumours have historically been excluded from the key clinical trials of immunotherapy. Patients with advanced non-melanomatous cutaneous spindle cell neoplasms have traditionally been offered chemotherapy for which response rates are variable and short-lived. Due to the impressive and durable response rates seen in our cohort of patients, clinicians should consider the use of ICIs in this heterogenous group of tumours. UV signatures and tumour mutational burden, if available, could serve as important biomarkers in the selection of patients for treatment with ICIs. Non-melanomatous cutaneous spindle cell neoplasms are a rare group of malignancies that present a diagnostic challenge, and for which there is a lack of consensus on how to best manage patients with advanced disease and only limited reports of immune-checkpoint inhibitor (ICI) responses. In this study, we performed a single-center retrospective review of treatment outcomes for all advanced non-melanomatous cutaneous spindle cell neoplasms treated with ICIs. Blinded histopathology reviews occurred to confirm each diagnosis. Comprehensive tumour profiling included whole exome sequencing for tumour mutational burden (TMB) and ultraviolet(UV) signatures, and immunohistochemistry for immune-cell infiltration (CD4/CD3/CD8/CD103/CD20) and immune-checkpoint expression (PD-L1/LAG3/TIGIT). Seven patients were identified. The objective response rate was 86% (6/7) with five complete responses (CR). Responses were durable with two patients in CR > 30 months after ICI commencement. All patients had high TMB and UV signatures. One patient had PD-L1 100% (combined positive score) with abundant immune-cell infiltration and LAG3 expression. In advanced non-melanomatous cutaneous spindle cell neoplasms, excellent responses to ICIs with durable disease control were observed. ICIs are worthy of further exploration in these patients. UV signatures and high TMB could be used to help select patients for treatment. [ABSTRACT FROM AUTHOR]

A robust workforce of locum tenens (LT) physicians is imperative for health service stability. A systematic review was conducted to synthesize current evidence on the strategies used to facilitate the recruitment and retention of LT physicians. English articles up to October 2023 across five databases were sourced. Original studies focusing on recruitment and retention of LT's were included. An inductive content analysis was performed to identify strategies used to facilitate LT recruitment and retention. A separate grey literature review was conducted from June–July 2023. 12 studies were retained. Over half (58%) of studies were conducted in North America. Main strategies for facilitating LT recruitment and retention included financial incentives (83%), education and career factors (67%), personal facilitators (67%), clinical support and mentorship (33%), and familial considerations (25%). Identified subthemes were desire for flexible contracts (58%), increased income (33%), practice scouting (33%), and transitional employment needs (33%). Most (67%) studies reported deterrents to locum work, with professional isolation (42%) as the primary deterrent-related subtheme. Grey literature suggested national physician licensure could enhance license portability, thereby increasing the mobility of physicians across regions. Organizations employ five main LT recruitment facilitators and operationalize these in a variety of ways. Though these may be incumbent on local resources, the effectiveness of these approaches has not been evaluated. Consequently, future research should assess LT the efficacy of recruitment and retention facilitators. Notably, the majority of identified LT deterrents may be mitigated by modifying contextual factors such as improved onboarding practices. [ABSTRACT FROM AUTHOR]

This document discusses the impact of carbon emissions on clinical trials and explores the carbon-relevant factors that influence participants' decisions to join and remain in trials. The study found that factors such as trial supplies and equipment, CTU emissions, trial-specific patient assessments, meetings and travel, and trial setup were the most frequently identified carbon-relevant factors. However, there was limited data on the influence of carbon on trial retention. The authors suggest that future studies should directly ask participants about the influence of carbon-relevant factors and involve patient partners in trial design discussions. [Extracted from the article]

Background Aims Methods Results Conclusions Lung cancer is the leading cause of cancer death in Australia. Immunotherapy has improved outcomes in patients with metastatic non‐small cell lung cancer (NSCLC). Pembrolizumab is approved in first‐line treatment as single‐agent immunotherapy (SAI) or combination chemoimmunotherapy (CIT). In metastatic NSCLC programmed death‐ligand 1 (PD‐L1) ≥50% either regimen may be used.We aim to identify patient and tumour characteristics that influence treatment selection.This is a retrospective observational study. Pharmacy records identified patients with metastatic/recurrent NSCLC receiving pembrolizumab at two metropolitan centres in Victoria, Australia, since 2018. Demographics, tumour characteristics, Charlson Comorbidity Index (CCI) and treatment data were collected. Descriptive and multivariate analyses were performed.Sixty‐one patients had metastatic NSCLC PD‐L1 ≥50% and received pembrolizumab with median age of 65.6 years, Eastern Cooperative Oncology Group 0–1 in 82%. CIT was administered to 23% (14) with no difference in rate of delivery between centres (P = 0.808). CCI mean score differed (3.38 SAI vs 2.36 CIT, P = 0.042). Patients with high CCI score (≥2) were less likely to receive CIT (OR = 0.15, P = 0.003, 95% confidence interval (CI) 0.04–0.57). Primary tumours over 5 cm were more likely to receive CIT (OR = 3.74, P = 0.043, 95% CI = 1.04–13.42). Site‐specific metastases of liver, brain and pericardial effusion were not associated with CIT.Patients with higher comorbidity score were less likely to receive CIT, suggesting chemotherapy avoidance in comorbid patients. Larger tumours are associated with CIT use, indicating that oncologists may use tumour size as a surrogate of disease burden. Limitations include small sample size and data cut‐off. Future prospective studies could incorporate comorbid status and a validated disease burden score to stratify patients. [ABSTRACT FROM AUTHOR]

Evaluating 100 adult coronavirus disease 2019 (COVID-19) patients at a Madrid hospital, we identified a mismatch between current clinical trial designs and the evolving profile of hospitalized patients. Most patients were ineligible due to design constraints, suggesting a need to rethink trial criteria for a more accurate representation of the hospitalized COVID-19 cohort. [ABSTRACT FROM AUTHOR]

Chronic hepatitis B, a major cause of liver disease and cancer, affects >250 million people worldwide. Currently there is no cure, only suppressive therapies. Efforts to develop finite curative hepatitis B virus (HBV) therapies are underway, consisting of combinations of multiple novel agents with or without nucleos(t)ide reverse-transcriptase inhibitors. The HBV Forum convened a webinar in July 2021, along with subsequent working group discussions to address how and when to stop finite therapy for demonstration of sustained off-treatment efficacy and safety responses. Participants included leading experts in academia, clinical practice, pharmaceutical companies, patient representatives, and regulatory agencies. This Viewpoints article outlines areas of consensus within our multistakeholder group for stopping finite therapies in chronic hepatitis B investigational studies, including trial design, patient selection, outcomes, biomarkers, predefined stopping criteria, predefined retreatment criteria, duration of investigational therapies, and follow-up after stopping therapy. Future research of unmet needs are discussed. [ABSTRACT FROM AUTHOR]

Balloon pulmonary angioplasty continues to gain traction as a treatment option for patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. Recent European Society of Cardiology guidelines on pulmonary hypertension now give balloon pulmonary angioplasty a Class 1 recommendation for inoperable and residual chronic thromboembolic pulmonary hypertension. Not surprisingly, chronic thromboembolic pulmonary hypertension centers are rapidly initiating balloon pulmonary angioplasty programs. However, we need a comprehensive, expert consensus document outlining critical concepts, including identifying necessary personnel and expertise, criteria for patient selection, and a standardized approach to preprocedural planning and establishing criteria for evaluating procedural efficacy and safety. Given this lack of standards, the balloon pulmonary angioplasty skill set is learned through peer-to-peer contact and training. This document is a state-of-the-art, comprehensive statement from key thought leaders to address this gap in the current clinical practice of balloon pulmonary angioplasty. We summarize the current status of the procedure and provide a consensus opinion on the role of balloon pulmonary angioplasty in the overall care of patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. We also identify knowledge gaps, provide guidance for new centers interested in initiating balloon pulmonary angioplasty programs, and highlight future directions and research needs for this emerging therapy. [ABSTRACT FROM AUTHOR]