Independent Investigators Research Articles

(026) “Hoping it Will be Better Next Time:” A Qualitative Analysis of Treatment Decision-making with Vulvodynia

Abstract Introduction Vulvodynia symptoms, experiences, and treatment response vary widely, and understanding of patient experiences and decision-making remain limited. Common diagnostic delays, varying responses to treatment, and the compounding nature of physical symptoms with psychosocial and sexual outcomes complicate patient treatment decisions. Understanding the factors that affect patients’ decision-making can help providers counsel on treatment options and build a therapeutic alliance. Objective This study aimed to explore individuals’ experiences with treatments for provoked vulvodynia and factors contributing to their therapeutic decision-making. Methods Through a descriptive, qualitative study design, we conducted six focus groups of 3-5 heterosexual, adult (ages 18-51) women with diagnosed provoked vulvodynia, vestibulodynia, or insertional dyspareunia. The semi-structured interviews addressed topics including 1) living with chronic vulvodynia, 2) the impact of vulvodynia on relationships and sexual function, 3) currently available treatment options and limitations of these treatments for vulvodynia, 4) clinical decision making regarding available treatments with providers, and 5) the introduction of a novel drug delivery system for targeted topical treatment to the vulvar vestibule. Participants also completed demographic questionnaires. Semi-structured focus group discussions were audio-recorded, transcribed verbatim, and coded by two independent investigators. Coding differences were resolved and consensus reached. This study analyzed selected codes and subsets of codes related to treatment decision-making, treatments tried, side effects, healthcare access, and the relationship with treating providers. This study was approved by the Institutional Review Board. Results Twenty women participated in the focus group discussions. The mean age for the participants was 33.3 years. Most participants were educated with at least some college (93%), White (78.6%), married (75%), and had income greater than $100,000 (50%). When discussing their experiences with treatment decision-making, participants relied on information given by providers and others, but exercised autonomy through independent research. Participants discussed balancing multiple factors including treatment cost, characteristics, impact on relationships and sex, and duration of effect. They also indicated the amount of time they had vulvodynia and the severity of their pain impacted their treatment choices. Most participants reported a history of “trial-and-error” approaches to treatment and shared concerns about possible side-effects. Despite many experiencing weariness and fatigue with their conditions and healthcare systems, they felt driven to persevere by their internal optimism and a desire for symptom relief. Conclusions Individuals with vulvodynia weighed a combination of information resources, treatment factors, internal motivations, and obstacles when choosing treatments. Most navigated experiences and decision-making through trial-and-error. Though often facing frustration and fatigue, they voiced hope for future success. Understanding patients’ frustrations with the “trial-and-error” nature of treatment can help providers set expectations and validate patients’ experiences. Addressing patients’ concerns around treatment cost, side-effects, impact on sex, and duration of treatment effects can facilitate individualized treatment planning and therapeutic algorithms for care. Further research into treatment decision-making for patients with vulvodynia would facilitate providers in counseling patients, and the development of targeted treatments indicated for vulvodynia would decrease trial-and-error approaches. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Dr. Erin T. Carey and Dr. S. Rahima Benhabbour have submitted a patent application related to this work filed by the University of North Carolina, Office of Technology Commercialization (UNC OTC) (PCT International Application PCT/US20/55816).

Auditing the safety and efficacy of interventional septal reduction therapies in hypertrophic obstructive cardiomyopathy at a specialized tertiary centre

Abstract Funding Acknowledgements Type of funding sources: None. Background Hypertrophic cardiomyopathy (HCM) is a recognized cause of sudden cardiac death and dysrhythmias. Patients with HCM and marked left ventricular outflow tract obstruction (LVOTO) may benefit from invasive therapies such as septal myectomy or alcohol septal ablation (ASA) (1). This study aimed to compare patient outcomes post-ASA and post-septal myectomy within a specialized tertiary centre. Purpose To establish the efficacy and safety outcomes of septal reduction therapies. Postoperative conduction abnormalities are the most common long-term postoperative complications in this population (2); however, specific patient outcomes at our tertiary heart centre were previously unknown. Methods This retrospective analysis included patients who underwent ASA (n= 66) or septal myectomy (n=151) between 2015 and 2021. Ethical approval was obtained before commencing the study. Two independent investigators extracted the preoperative and postoperative data from echocardiograms, electrocardiograms, clinic letters, and discharge forms. Normally distributed variables were reported as mean and standard deviation and analysed using an unpaired T-test with Welch's correction. Non-normally distributed variables were reported as median and interquartile range and analysed using the Mann-Whitney U test. Results The mean follow-up time was 2.69 ±1.37 years in the ASA cohort and 1.38 ±1.18 years in the myectomy cohort. There were no differences in gender or ethnic composition; however, on average, patients in the ASA cohort were 10.40 ± 1.82 years older than those in the myectomy cohort (95% CI: 13.99 to 6.81, p< 0.0001). Significant improvements in New York Heart Association (NYHA) class occurred across both cohorts (p< 0.0001). Post-ASA resting LVOT gradients decreased from 54.00 to 13.00 mmHg (95% CI: -45.00 to -21.00, p< 0.0001). Post-myectomy resting LVOT gradients decreased from 60.00 to 4.90 mmHg (95% CI: -57.00 to -41.00, p< 0.0001) and were significantly lower than post-ASA (p= 0.0007). In addition, re-intervention rates were higher post-ASA compared to post-myectomy 40% vs 1.32% respectively, (p< 0.0001). ASA also carried a greater risk of permanent pacemaker implantation 18% vs. 8% (p=0.0270), complete heart block 22% vs. 6% (p= 0.0016), and right bundle branch block 28% vs 0% (p< 0.0001) compared to septal myectomy. In contrast, septal myectomy had a greater risk of postoperative atrial fibrillation 20% vs 1.5% (p= 0.0004), and left bundle branch block 60% vs 7% (p< 0.0001) compared to ASA. Perioperative mortality was 0 (0%) in both cohorts. Conclusion In conclusion, both interventions were safe and provided significant symptomatic relief and effective gradient reduction. However, conduction abnormalities remain a considerable risk of septal reduction therapies and may contribute to patient morbidity. More research is needed to minimize intervention risks and further improve patient outcomes.

Reacting, Sharing, and Commenting: How Many Facebook Users Are Engaging with Posts Related to Dental Caries That Contain Misinformation?

Recent studies have been concerned about the vast amount of misinformation detected on social media that directly hampers the prevention and control of chronic diseases. Based on these facts, the aim of this study was to identify and characterize misinformation about dental caries-related content found on Facebook, regarding the predictive factors of user interaction with posts. Then, CrowdTangle retrieved 2,436 posts published in English, ordered by the total interaction of the highest users. A total of 1,936 posts were selected for inclusion and exclusion criteria to select a sample of 500 posts. Subsequently, two independent investigators characterized the posts by their time of publication, author’s profile, motivation, the aim of content, content facticity, and sentiment. The statistical analysis was performed using Mann-Whitney U and χ² tests and multiple logistic regression models to determine differences and associations between dichotomized characteristics. p values <0.05 were considered significant. In general, posts were predominantly originated from the USA (74.8%), related to business profiles (89%), presented preventive content (58.6%), and noncommercial motivation (91.6%). Furthermore, misinformation was detected in 40.8% of the posts and was positively associated with positive sentiment (OR = 3.43), business profile (OR = 2.22), and treatment of dental caries (OR = 1.60). While the total interaction was only positively associated with misinformation (OR = 1.44), the overperforming score was associated with posts from the business profile (OR = 5.67), older publications (OR = 1.57), and positive sentiment (OR = 0.66). In conclusion, misinformation was the unique predictive factor of increased user interaction with dental caries-related posts on Facebook. However, it did not predict the performance of the diffusion of posts such as business profiles, older publications, and negative/neutral sentiment. Therefore, it is essential to promote the development of specific policies toward good quality information on social media, which includes the production of adequate materials, the increase of the critical sense of consuming health content, and information filtering mediated by digital solutions.

Development of a new radiographic score for the follow-up of calcific tendinopathy of the rotator cuff.

The aim of this study was to evaluate the psychometric properties of a new x-ray scoring system for calcific tendinopathy of the rotator cuff (CTRC). This is a post-hoc analysis of the CALCECHO trial. All patients received an ultrasound-guided puncture and lavage of their calcification. Clinical data and x-rays from baseline and follow-up visits at 7 days (D7), 3 months (M3) and 12 months (M12) were used. The scoring system was based on the reduction in size and density of the calcification compared to the initial x-ray (0 = no change; 1 = decrease of less than 50%; 2 = decrease of between 50 and 90%; 3 = decrease of more than 90%; 4 = complete disappearance). Inter-observer and intra-observer reliability were established between 3 independent investigators (2 experts and one junior) using weighted Kappa calculation. Construct validity was assessed as well as predictive validity and sensitivity to change. Between the two experts, inter-reader reliability was at 0.677, 0.744 and 0.656 at D7, M3 and M12 respectively. Intra-reader reliability was between 0.577 and 0.836 for the two expert readers and between 0.519 and 0.697 for the junior reader. Our score was correlated with shoulder pain and function at M3 and M12 and the score at M3 was predictive of the clinical outcome at M12. Finally, sensitivity to change was 0.8. Our new score presented good psychometric properties and was correlated with clinical data. It could be useful in the follow-up of patients treated for CTRC.

GLP-1 analogs and regional adiposity: A systematic review and meta-analysis.

Glucagon-like peptide 1 (GLP-1) analogs regulate body weight and liver steatosis. Different body adipose tissue (AT) depots exhibit biological variability. Accordingly, GLP-1 analog effects on AT distribution are unclear. To investigate GLP1-analog effects on adiposity distribution. PubMed, Cochrane, and Scopus databases were screened for eligible randomized human trials. Pre-defined endpoints included visceral AT (VAT), subcutaneous AT (SAT), total AT (TAT), epicardial AT (EAT), liver AT (LAT), and waist-to-hip ratio (W:H). Search was conducted until May 17, 2022. Data extraction and bias assessment were performed by two independent investigators. Treatment effects were estimated using random effects models. Analyses were performed on Review Manager v5.3. Out of the 367 screened studies, 45 were included in the systematic review and 35 were used in the meta-analysis. GLP-1 analogs reduced VAT, SAT, TAT, LAT, and EAT, with non-significant effects on W:H. Overall bias risk was low. GLP-1 analog treatment reduces TAT, affecting most studied AT depots, including the pathogenic VAT, EAT, and LAT. GLP-1 analogs may have significant roles in combating metabolic, obesity-associated diseases via reductions of key AT depot volumes.

Scientific evidence of sodium-glucose cotransporter-2 inhibitors for heart failure with preserved ejection fraction: an umbrella review of systematic reviews and meta-analyses.

It remains controversial whether sodium-glucose cotransporter-2 inhibitors (SGLT-2is) are effective in treating heart failure with preserved ejection fraction (HFpEF). The objective of this umbrella review is to provide a summary of the available evidence regarding the efficacy and safety of SGLT-2is for the treatment of HFpEF. We extracted pertinent systematic reviews and meta-analyses (SRs/MAs) from PubMed, EMBASE, and the Cochrane Library that were published between the inception of the database and December 31, 2022. Two independent investigators assessed the methodological quality, risk of bias, report quality, and evidence quality of the included SRs/MAs in randomized controlled trials (RCTs). We further evaluated the overlap of the included RCTs by calculating the corrected covered area (CCA) and assessed the reliability of the effect size by performing excess significance tests. Additionally, the effect sizes of the outcomes were repooled to obtain objective and updated conclusions. Egger's test and sensitivity analysis were used to clarify the stability and reliability of the updated conclusion. This umbrella review included 15 SRs/MAs, and their methodological quality, risk of bias, report quality, and evidence quality were unsatisfactory. The total CCA for 15 SRs/MAs was 23.53%, indicating a very high level of overlap. The excess significance tests did not reveal any significant results. Our updated MA demonstrated that the incidence of the composite of hospitalization for heart failure (HHF) or cardiovascular death (CVD), first HHF, total HHF, and adverse events as well as the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and 6 min-walk distance (6MWD) were all substantially improved in the SGLT-2i intervention group compared to the control group. However, there was limited evidence that SGLT-2is could improve CVD, all-cause death, plasma B-type natriuretic peptide (BNP) level, or plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level. Egger's test and sensitivity analysis proved that the conclusion was stable and reliable. SGLT-2 is a potential treatment for HFpEF with favourable safety. Given the dubious methodological quality, reporting quality, evidence quality, and high risk of bias for certain included SRs/MAs, this conclusion must be drawn with caution. https://inplasy.com/, doi: 10.37766/inplasy2022.12.0083, identifier INPLASY2022120083.

Pharmaceutical care and asthma: Protocol of an umbrella review of systematic reviews

IntroductionRecent systematic reviews and meta-analyses suggest that pharmacists' interventions in asthma patients have a positive impact on health-related outcomes. Nevertheless, the association is not well established and the role of clinical pharmacists is poorly represented, as well as severe asthma patients.The aim of this overview of systematic reviews is to identify published systematic reviews assessing the impact of pharmacists' interventions on health-related outcomes measured in asthma patients, as well as to describe key components of the interventions, the outcomes assessed and any associations between pharmacists' interventions and health-related outcomes. MethodsPubMed, Embase, Scopus and the Cochrane Library will be searched from inception to December 2022. Systematic reviews of all study designs, severity of asthma and level of care that measured health-related outcomes will be considered. Methodological quality will be assessed using A Measurement Tool to Assess Systematic Reviews 2. Two independent investigators will perform the study selection, quality assessment and data collection, any discrepancy will be solved by a third investigator. Both narrative findings and meta-analysis of primary study data included in the systematic reviews will be synthesised. If data are appropriate for quantitative synthesis, the measures of association will be expressed as the risk ratio and difference in means. DiscussionThe first results on the establishment of a multidisciplinary network for the management of asthmatic patients have shown the benefits of integrating different levels of care in disease control and morbidity reduction. Further studies showed benefits in hospital admissions, patients' basal oral corticosteroid dose, exacerbations and quality of life of asthma patients.A systematic review is the most appropriate design in order to summarise the literature and identify the evidence of the benefits of interventions performed by clinical pharmacists in asthma patients, especially those with severe uncontrolled asthma, and encourage future studies to stablish the role of clinical pharmacists in asthma units. Registration detailsSystematic review registration number: CRD42022372100.

A systematic review of digital interventions for smoking cessation in patients with serious mental illness.

Tobacco smoking is highly prevalent among patients with serious mental illness (SMI), with known deleterious consequences. Smoking cessation is therefore a prioritary public health challenge in SMI. In recent years, several smoking cessation digital interventions have been developed for non-clinical populations. However, their impact in patients with SMI remains uncertain. We conducted a systematic review to describe and evaluate effectiveness, acceptability, adherence, usability and safety of digital interventions for smoking cessation in patients with SMI. PubMed/MEDLINE, EMBASE, CINAHL, Web of Science, PsychINFO and the Cochrane Tobacco Addiction Group Specialized Register were searched. Studies matching inclusion criteria were included and their information systematically extracted by independent investigators. Thirteen articles were included, which reported data on nine different digital interventions. Intervention theoretical approaches ranged from mobile contingency management to mindfulness. Outcome measures varied widely between studies. The highest abstinence rates were found for mSMART MIND (7-day point-prevalent abstinence: 16-40%). Let's Talk About Quitting Smoking reported greater acceptability ratings, although this was not evaluated with standardized measures. Regarding usability, Learn to Quit showed the highest System Usability Scale scores [mean (s.d.) 85.2 (15.5)]. Adverse events were rare and not systematically reported. Overall, the quality of the studies was fair to good. Digitally delivered health interventions for smoking cessation show promise for improving outcomes for patients with SMI, but lack of availability remains a concern. Larger trials with harmonized assessment measures are needed to generate more definitive evidence and specific recommendations.

The comparison of endoscopic septoplasty and conventional septoplasty: A PRISMA analysis

ObjectiveSeptoplasty is a surgical procedure to correct the deviated nasal septum (DNS). There are two main approaches to address septoplasty – conventional (CS) and endoscopic septoplasty (ES). This study is aimed to compare the perioperative complications following the two techniques, compare postoperative nasal obstruction between the two approaches, and assess the quality of the available evidence. MethodsA systematic literature search was carried out across multiple databases by independent investigators. We extracted relevant articles that compared conventional septoplasty to endoscopic septoplasty. Cochrane risk of bias tool (RoB2) and Newcastle Ottawa Scale (NOS) was used for the quality assessment of randomized and non-randomized studies, respectively. The objectives comprised immediate surgical complications, surgical length, postoperative nasal obstruction, and quality of life. We incorporated follow-up periods into the univariate meta-regression analyses. ResultsA total of 2055 patients from 28 studies were included in this study. The endoscopic technique showed significantly lower risks of surgical complications. No difference was found in surgical length (3 studies MD 6minutes [95%CI –25–14], P=0.57). Postoperative nasal obstruction was lower in ES but varies with the follow-up periods. Functional assessment scores using NOSE and quality of life were similar between the two approaches. Risk of bias assessment of the included studies showed an overall moderate- to high-risk of bias. ConclusionEndoscopic septoplasty demonstrates a lower risk of complications. Long-term benefits of nasal obstruction were likely similar in the two techniques. Further high quality of studies is still warranted, and conclusions should be taken with discretion given the low quality of the included studies in this present meta-analysis.

Effects of citrulline on endurance performance in young healthy adults: a systematic review and meta-analysis.

Citrulline is a popular dietary supplement, primarily thought to exert ergogenic effects on exercise performance through the enhancement of nitric oxide (NO) synthesis and ammonia buffering. However, recent findings surrounding citrulline's effect on endurance performance have been inconsistent. A systematic review and meta-analysis of the relevant literature have yet to be undertaken. To determine if acute ingestion of citrulline has an ergogenic effect on endurance performance in young healthy adults. A systematic search of three databases was undertaken to find peer-reviewed randomized controlled trials (RCTs) published in English investigating the effects of citrulline supplementation on endurance performance in young healthy adults. Two independent investigators completed a three-phased screening procedure against pre-determined eligibility criteria. Included studies evaluated loading or bolus dosage regimes of citrulline in participants aged 18 or over that were at least recreationally active. Outcome measures focused on time-to-completion (TTC) or time-to-exhaustion (TTE) in continuous submaximal intensity exercise. Cochrane's Risk of Bias 2 (RoB 2) tool was used to assess the risk of bias in individual studies. Meta-analysis was conducted using a fixed-effects model to pool the weighted estimate of standardized mean differences (SMD) across studies. A chi-squared test assessed heterogeneity between studies. This review was conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Nine studies (n = 158 participants) met the eligibility criteria; five reported TTE outcomes (I2 = 0%, χ2 = 0.37, df = 4, P = 0.99) and four reported TTC outcomes (I2 = 0%, χ2 = 0.46, df = 3, P = 0.93), both with a low between-study heterogeneity. The results of the meta-analyses showed no significant difference in the endurance performance measures, TTE (pooled SMD = 0.03 [-0.27, 0.33]) and TTC (pooled SMD = -0.07 [-0.50, 0.15]), after acute ingestion of citrulline supplementation or a control in young healthy adults. The current evidence suggests no significant benefit of citrulline supplementation for endurance performance. However, the small evidence base requires further research to fully evaluate this topic. Recommendations include a focus on female populations; higher continuous doses of citrulline over seven days; and TTC outcome measures over longer distances to simulate competition.

The Role of Electrophysiological Study in the Risk Stratification of Brugada Syndrome.

Brugada syndrome (BrS) is a complex arrhythmogenic disease associated with an increased risk of sudden cardiac death (SCD). The role of electrophysiological study (EPS) for risk stratification purposes of asymptomatic BrS patients remains still controversial. This study aims to summarize the existing data about the role of electrophysiological study for arrhythmic risk stratification of BrS patients without a prior history of aborted SCD or fatal arrhythmic event. Two independent investigators (G.B. and G.T.) performed a systematic search in the MedLine database and Cochrane library from their inception until April 2022 without any limitations. The reference lists of the relevant research studies as well as the relevant review studies and meta-analyses were manually searched. Nineteen studies were included in the final analysis. The included studies enrolled 6218 BrS patients (mean age: 46.9 years old, males: 76%) while 4265 (68.6%) patients underwent an EPS. The quantitative synthesis showed that a positive EPS study was significantly associated with arrhythmic events in BrS patients (RR, 1.74 [1.23-2.45]; P = 0.002; I2 = 63%]. By including the studies that provided data on the association of EPS with arrhythmic events during follow-up in patients without a prior history of aborted SCD or fatal arrhythmic event, the association between positive EPS study and future arrhythmic events remained significant (RR, 1.60 [1.08-2.36]; P = 0.02; I2 = 19%). In conclusion, EPS is a useful invasive tool for the risk stratification of BrS patients and can be used to identify the population of BrS patients who may be candidates for primary prevention of SCD with implantable cardioverter-defibrillator (ICD) implantation.

Turnover intention among healthcare workers in Ethiopia: a systematic review and meta-analysis

ObjectiveTo determine the pooled prevalence of turnover intention among healthcare workers in Ethiopia.DesignA systematic review and meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and...

Association between bilirubin levels and risk of stroke: a systematic review and meta-analysis

ObjectiveTo evaluate the association between bilirubin levels and stroke risk.DesignSystematic review and meta-analysis, reported in accordance with Meta-analysis Of Observational Studies in Epidemiology guidelines.Data sourcesThe PubMed, Embase, Cochrane Central Register...

An evaluation of quantitative percussion diagnostics for determining the probability of a microgap defect in restored and unrestored teeth: A prospective clinical study

Statement of problemCurrent dental diagnostics are image based and cannot detect a structural microgap defect such as a crack in a tooth. Whether percussion diagnostics can effectively diagnose a microgap defect is unclear. PurposeThe purpose of the present study was to determine from a large multicenter prospective clinical study whether quantitative percussion diagnostics (QPD) could detect structural damage in teeth and whether a probability of its presence could be provided. Material and methodsA nonrandomized prospective and multicenter clinical validation study with 224 participants was performed in 5 centers with 6 independent investigators. The study used QPD and the normal fit error to determine whether a microgap defect was present in a natural tooth. Teams 1 and 2 were blinded. Team 1 tested teeth scheduled for restoration with QPD, and Team 2 disassembled the teeth aided by a clinical microscope, transillumination, and a penetrant dye. Microgap defects were documented in written and video formats. Controls were participants without damaged teeth. The percussion response from each tooth was stored on a computer and analyzed. A total of 243 teeth were tested to provide approximately 95% power to test the performance goal of 70%, based on an assumed population overall agreement of 80%. ResultsRegardless of the collection method, tooth geometry, restoration material used, or restoration type, the data on detecting a microgap defect in a tooth were accurate. The data also reflected good sensitivity and specificity consistent with previously published clinical studies. The combined study data showed an overall agreement of 87.5% with a 95% confidence interval (84.2 to 90.3), beyond the 70% predetermined performance goal. The combined study data determined whether it was possible to predict the probability of a microgap defect. ConclusionsThe results showed that the data on detecting microgap defects in a tooth site were consistently accurate and confirmed that QPD provided information to aid the clinician in treatment planning and early preventative treatment. QPD can also alert the clinician of probable diagnosed and undiagnosed structural problems via the use of a probability curve.

Evaluation of health utility in trial-based cost–utility analyses for major cardiovascular disease: protocol for a systematic review

IntroductionThe global incidence of cardiovascular disease (CVD) is high, and the medical costs associated with its management have been increasing. Cost–utility analyses (CUAs) are essential for understanding the value of...

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Factors Impacting Outcomes in Brainstem Hemorrhage: A Single-center Experience Investigating Functional Outcome (P6-5.026)

<h3>Objective:</h3> To describe the functional outcomes and determine favorable prognostic factors in patients with brainstem hemorrhage. <h3>Background:</h3> Brainstem hemorrhage comprises 5–10% of intracranial hemorrhages (ICH) and is historically known to be associated with significant disability and high-mortality. Studies investigating functional outcome are limited and this presumption of poor prognosis can lead to premature withdrawal of care and self-fulfilling prophecy. <h3>Design/Methods:</h3> We retrospectively reviewed all ICH patients admitted to our center from 2017–2021 and identified CT-proven brainstem hemorrhage patients. We gathered demographic information, clinical and radiological parameters, outcome measures during and after hospitalization. The Modified Rankin scale (mRS) at 3–6 months was adjudicated by three independent investigators. Univariate analysis was performed to identify possible associations between outcome and potential prognostic factors using Mann-Whitney, Chi-square, and t-tests. <h3>Results:</h3> Among 569 ICH patients admitted, 29 (5%) brainstem hemorrhages were identified. 15 (52%) were male and 14 (48%) were female, with ages ranging from 20–91 (mean 61.9). The mortality rate was 52%, while 10 patients (34.5%) had good recovery (mRS 0–2). Age, gender, race, and hemorrhage location didn’t differ between groups. Our analysis demonstrated that the Glasgow coma scale (GCS) at admission, hemorrhage volume (ABC/2), ICH score, functional outcome in patients with primary ICH (FUNC) score, and early withdrawal of care were all significantly associated with both functional outcome and mortality. <h3>Conclusions:</h3> In our center, the percentage of brainstem hemorrhages and mortality was consistent with previous studies however there was a higher percentage of patients with good outcomes than previously reported in the literature. Despite sample size and study design limitations, our study suggests GCS at admission, lower hemorrhage volume, and favorable ICH severity scales were potential factors associated with good prognosis, while early withdrawal of care was associated with higher mortality. Identification of reliable prognostic factors is important to guide clinical management and prevent premature withdrawal of care. <b>Disclosure:</b> Dr. Gunduz has nothing to disclose. Miss Fleming has nothing to disclose. Dr. Sivakumar has nothing to disclose. Dr. Shaikh has nothing to disclose. Dr. Carandang has nothing to disclose.

Effect of Intracoronal Sealing Biomaterials on the Histological Outcome of Endodontic Revitalisation in Immature Sheep Teeth—A Pilot Study

The influence of intracoronal sealing biomaterials on the newly formed regenerative tissue after endodontic revitalisation therapy remains unexplored. The objective of this study was to compare the gene expression profiles of two different tricalcium silicate-based biomaterials alongside the histological outcomes of endodontic revitalisation therapy in immature sheep teeth. The messenger RNA expression of TGF-β, BMP2, BGLAP, VEGFA, WNT5A, MMP1, TNF-α and SMAD6 was evaluated after 1 day with qRT-PCR. For evaluation of histological outcomes, revitalisation therapy was performed using Biodentine (n = 4) or ProRoot white mineral trioxide aggregate (WMTA) (n = 4) in immature sheep according to the European Society of Endodontology position statement. After 6 months' follow-up, one tooth in the Biodentine group was lost to avulsion. Histologically, extent of inflammation, presence or absence of tissue with cellularity and vascularity inside the pulp space, area of tissue with cellularity and vascularity, length of odontoblast lining attached to the dentinal wall, number and area of blood vessels and area of empty root canal space were measured by two independent investigators. All continuous data were subjected to statistical analysis using Wilcoxon matched-pairs signed rank test at a significance level of p < 0.05. Biodentine and ProRoot WMTA upregulated the genes responsible for odontoblast differentiation, mineralisation and angiogenesis. Biodentine induced the formation of a significantly larger area of neoformed tissue with cellularity, vascularity and increased length of odontoblast lining attached to the dentinal walls compared to ProRoot WMTA (p < 0.05), but future studies with larger sample size and adequate power as estimated by the results of this pilot study would confirm the effect of intracoronal sealing biomaterials on the histological outcome of endodontic revitalisation.

Evaluating Performance of Circular Staplers Using Comparative Test Methods for Evidence-Based Surgery.

Circular stapler anastomosis is a common surgical procedure. Despite technological advancements, anastomotic leak remains a postoperative concern. Assessment of new technologies is impeded by variations in test methods and analysis, precluding outcome reproducibility and direct comparisons of results across studies. The development of robust and reproducible preclinical test methods is critical to accelerating stapling technology advancements. Leak pressure, staple line perfusion and security, and device removal force were quantified for triple-row (Tri-staple EEA, TriEEA) and double-row staplers (Echelon Circular Powered, ECP). Leak and perfusion testing were performed in vivo. Device removal force and staple line security testing were performed with synthetic medium using an Instron. Data were analyzed using unpaired student's t-test or Kruskal-Wallis test, with statistical significance defined as P < .05. Leak pressure was 73% higher in TriEEA vs ECP (P = .016). TriEEA staple line failure force was lower than ECP at 40 and 50mmHg (P = .001 and P = .023, respectively). Perfusion to the staple line was higher (148%) for TriEEA than for ECP (P = .003) and the force required to remove the device from its stapled anastomosis was 78% lower for TriEEA than for ECP (P < .001). This report addresses a primary limitation in stapling research by presenting novel methodologies which enhance clinical relevance and provide sufficient detail for reproduction by independent investigators. These methods are applied to a comparison between triple-row and double-row staplers to demonstrate utility of new test methods in assessing key technology design features.

Peripheral location of lung cancer is associated with higher local disease recurrence.

Our goal was to evaluate the association between the distance of the tumour to the visceral pleura and the rate of local recurrence in patients surgically treated for stage pI lung cancer. We conducted a single-centre retrospective review of 578 consecutive patients with clinical stage IA lung cancer who underwent a lobectomy or segmentectomy from January 2010 to December 2019. We excluded 107 patients with positive margins, previous lung cancer, neoadjuvant treatment and pathological stage II or higher status or for whom preoperative computed tomography (CT) scans were not available at the time of the study. The distance between the tumour and the closest visceral pleura area (fissure/mediastinum/lateral) was assessed by 2 independent investigators who used preoperative CT scans and multiplanar 3-dimensional reconstructions. An area under the receiver operating characteristic curve analysis was performed to determine the best threshold for the tumour/pleura distance. Then multivariable survival analyses were used to assess the relationship between local recurrence and this threshold in relation to other variables. Local recurrence occurred in 27/471 patients (5.8%). A cut-off value of 5 mm between the tumour and the pleura was determined statistically. In the multivariable analysis, the local recurrence rate was significantly higher in patients with a tumour-to-pleura distance ≤5 mm compared to patients with a tumour-to-pleura distance >5 mm (8.5% vs 2.7%, hazard ratio 3.36, 95% confidence interval: 1.31-8.59, P = 0.012). Subgroup analyses of patients with pIA and tumour size ≤2 cm identified local recurrences in 4/78 patients treated with segmentectomy (5.1%), with a significantly higher occurrence with tumour-to-pleura distances ≤5 mm (11.4% vs 0%, P = 0.037), and in 16/292 patients treated with lobectomy (5.5%) without significant higher occurrence in tumour-to-pleura distances of ≤5 mm (7.7% vs 3.4%, P = 0.13). The peripheral location of a lung tumour is associated with a higher rate of local recurrence and should be taken into account during preoperative planning when considering segmental versus lobar resection.