Inclusion Criteria Research Articles

767. INFLUENCE OF NEOADJUVANT IMMUNOTHERAPY-CHEMOTHERAPY ON PERIOPERATIVE OUTCOMES IN LOCALLY ADVANCED ESOPHAGEAL ADENOCARCINOMA

Abstract Background This study evaluates the perioperative outcomes of patients with locally advanced esophageal adenocarcinoma (EAC) who were treated with neoadjuvant immunotherapy (IO) and chemotherapy versus a matched cohort of patients that received neoadjuvant chemotherapy (NAC) alone. Methods A single center non-randomized phase II trial was undertaken in locally advanced (cT3-4 and/or N+) EAC and 49 patients completed neoadjuvant Avelumab + DCF (Docetaxel, Cisplatin, 5FU) and esophagectomy between 2/2018 and 2/2020. These patients were matched to contemporary patients (1/2018-6/2020) who met inclusion criteria but received neoadjuvant chemotherapy alone (NAC) with a comparable Docetaxel based. The postoperative outcomes were then compared between the two groups. Results Ninety-nine patients with locally advanced EAC underwent esophagectomy and meet enrolment criteria for this study. Of these patients, 50 received NAC alone 49 received IO+NAC. Baseline characteristics such as age, gender and clinical stage were comparable between groups. Operative approach and rate of MIE (~60%) was similar in both groups. Overall and major complication rate were similar between groups (50 vs. 51%, p=0.91; 20 vs. 26%, p=0.44 respectively) with concordant rates of anastomotic leak (6 [12%] vs. 6 [12%], p=0.86) and respiratory complications (13 [26%] vs. 11 [22%], p=0.68) in NAC alone and IO+NAC group respectively. There were no significant differences in the LOS and 30- and 90-days mortality rates between the two groups. Conclusion The addition of immunotherapy to neoadjuvant chemotherapy for locally advanced esophageal adenocarcinoma does not appear to significantly alter perioperative short-term outcomes after esophagectomy

The Role of Corticosteroid Injections in the Treatment of Sacroiliitis: A Narrative Review.

Axial spondyloarthritis (axSpA) is a chronic rheumatic, musculoskeletal, inflammatory disease with a propensity to present as sacroiliitis, which manifests as low back, buttock, or thigh pain. Effective primary management of axSpA requires a comprehensive approach specific to each patient and disease severity. Non-pharmacological measures form the cornerstone of treatment. With refractory disease, management also consists of local periarticular and intraarticular injections. The use of sacroiliac joint (SIJ) corticosteroid injections for the treatment of axSpA and localised inflammation, however, is a continuously burgeoning management option. This narrative review aims to present consolidated findings and summarise previously unreferenced or recently available evidence regarding corticosteroid injections to the SIJ for treating sacroiliitis and axSpA. A comprehensive literary review with the following electronic databases was searched: MEDLINE via PubMed, Web of Science, Cochrane Library, and EMBASE. The initial search yielded a total of 126 references. After duplicates were removed and the remainder analysed for inclusion criteria, 7 studies were included. To stratify each study, injection methodology and characteristics were defined. The use of SIJ corticosteroid injections can be an appropriate and effective treatment option for refractory axSpA. The studies presented in this review reported a general trend towards a reduction in pain severity after SIJ corticosteroid injections. Because of the complexity and heterogeneity of the anatomy of the SIJ, image guidance is recommended when performing SIJ injections. Image-guided injections seem to produce better outcomes when compared to anatomic landmark-guided injections.

Prescribing patterns of statins and associated factors among type 2 diabetes mellitus patients in Africa: a systematic review and meta-analysis

BackgroundIn sub-Saharan African nations, there's a documented shortfall in the utilization of statins, despite established clinical guidelines advocating their use for reducing cardiovascular risks and overall mortality among Type 2 diabetes patients aged 40 to 75 years old. Most clinical guidelines recommend prescribing statins to individuals with Type 2 Diabetes to reduce the chances of cardiovascular disease. There is currently a lack of extensive research on statin utilization specifically for primary prevention of cardiovascular disease in Africa. Thus, this study aimed to assess the prescription patterns of statins for preventing cardiovascular disease in Type 2 diabetes patients. MethodsThe findings of the review were presented following the guidelines outlined in the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA-2020) checklist. We conducted searches on electronic databases including PubMed, EMBASE, Cochrane Library, Science Direct, African Journal Online, and Google Scholar. This systematic review and meta-analysis included articles that met specific inclusion criteria: observational studies such as cross-sectional, cohort, and case-control studies focusing on determinants, risk factors, or correlates associated with statin prescription within Africa. Only published articles up to June 2, 2024, published in English, and conducted in either community or healthcare facility settings were considered. Data import was initially conducted using Microsoft Excel, and statistical analysis was performed using STATA software. Cochran's Q test was employed to assess whether there was a significant variance in prevalence among the studies. Additionally, the I2 statistic was utilized to quantify the extent of heterogeneity. A funnel plot, a visual tool, was utilized to evaluate publication bias. ResultsThe search strategy resulted in 7695 published original articles. The full texts of the 89 papers were assessed for eligibility and quality. Moreover, some articles were rejected due to inaccuracies in the outcome variable. Ultimately, only ten studies focusing on the prevalence of statin prescription were examined. The research suggests that the pooled prevalence of statin prescription among Type 2 diabetic individuals in Africa is found to be 48.82% (95% CI: 35.41-63.24). Age greater than 65 years (AOR = 3.56, 95% CI: 1.70– 7.45; I2 = 54.7%), comorbidity (AOR= 1.13, 95% CI: 0.27 – 4.63, I2=96.4%), dyslipidemia (AOR= 3.15, 95% CI: 1.54 – 6.44, I2=61.7%), DM duration greater than ten years (AOR= 1.36, 95% CI: 0.81 – 2.28, I2=77.3%), and government insurance (AOR= 8.85, 95% CI: 2.72 – 28.76, I2=81.5%) were factors associated with statin prescription among type 2 diabetic patients. ConclusionsIn general, the extent of statin prescriptions for individuals with type 2 diabetes who are eligible for statin therapy was below the target outlined by clinical practice guidelines. Being over 65 years old, having comorbidities, experiencing dyslipidemia, having type 2 diabetes for more than ten years, and having government insurance were all identified as independent factors predicting the prescription of statins. This finding is concerning and underscores the urgent need to enhance adherence to clinical practice guidelines for the well-being of this vulnerable population at high risk.

537. ASSESSING THE EFFECT OF HIATAL HERNIA SIZE ON PERIOPERATIVE OUTCOMES AND HOSPITAL READMISSION RATES AFTER PRIMARY REPAIR

Abstract Background Minimally invasive hiatal hernia (HH) repair remains the gold standard for correcting mechanical defects due to its safety and favorable clinical outcomes (i.e., relief of patient symptoms). However, several operative factors, including the HH size, may negatively impact the postoperative course. We aimed to determine if an increase in HH size was related to an increased risk of perioperative complications or hospital readmissions. Methods After IRB approval, we performed a retrospective analysis using a prospectively maintained database containing demographic, perioperative, and clinical data from all patients who underwent HH repair by a single experienced foregut surgeon between September 2016 and July 2023. Four groups were defined based on the proportion of stomach at the thoracic cavity determined during the surgery: A (small HH: <25%), B (moderate HH: 25-49%), C (large HH: 50-74%), and D (intrathoracic stomach [ITS]: ≥75%). Non-parametric tests were used to assess differences between the groups, and logistic regressions were used to determine the relevant odds ratios (OR). Results A total of 391 patients who underwent primary HH repair met the inclusion criteria (73.7% women; mean age 64.4±12.5 years; mean BMI 28.9±4.9 kg/m2). The distribution of groups was: A (n=160, 40.9%), B (n=63, 16.1%), C (n=64, 16.4%), and D (n=104, 26.6%). Patients presenting with ITS (group D) were older, had longer operative duration, greater blood loss (p<.001), and a significantly increased risk of presenting with early postoperative complications (OR 2.78 [CI95: 1.52-5.06]) and being admitted to the ICU (OR 12.35 [CI95: 3.41-44.71]). Conclusion The HH size, defined by the proportion of the stomach at the thoracic cavity, is associated with an increased risk of early postoperative complications and ICU admission; moreover, a trend toward higher 30- and 90-day hospital readmission rates was noted. This factor may be a consequence of the progressive nature of the disease; hence, it should be considered when choosing between continued medical observation and surgical treatment of patients presenting with asymptomatic HH. An early intervention may reduce the risk of postoperative comorbidity.

360. RECURRENCE PATTERNS AFTER PRIMARY SURGERY AND NEOADJUVANT CHEMORADIOTHERAPY FOR ESOPHAGEAL ADENOCARCINOMA: ACROSS THE CROSS RECURRENCES

Abstract Background Our publication Across the CROSS in daily practice challenged the routine use of neoadjuvant chemoradiotherapy for locally advanced esophageal adenocarcinoma, showing a comparable 5-year overall and disease-free survival after primary surgery. This current study reevaluated overall and disease-free survival on long term and aimed to differentiate recurrence patterns and its final impact on overall survival. Methods This retrospective cohort study with propensity score-matched analysis included all surgically treated patients between 2000 and 2018 with locally advanced adenocarcinoma (cT1/2N+ or cT3/4N0/+). Exclusion criteria of the CROSS trial were applied. Patients were matched on age, Charlson comorbidity score, clinical tumor length, and lymph node status. The primary end point was time to recurrence. Results 149 propensity score-matched cases were defined in each group. There was still no significant difference after 10 years in median overall survival (33.6 vs 34.9 months, p=0.52) and median disease-free survival (14.1 vs 14.0 months, p=0.13) between both groups. Furthermore, nCRT resulted in a shorter time to overall recurrence (6.3 vs 11.5 months, p=0.004) and locoregional recurrence (6.3 vs 13.6 months, p=0.005). Additionally, overall survival after diagnosis of recurrence was also significantly shorter for nCRT patients than for primary surgery patients (6.9 vs 9.6 months, p=0.032). Conclusion Our propensity score-matched results indicate that primary surgery can offer a comparable long-term overall and disease-free survival as nCRT followed by surgery. Both overall and locoregional recurrences occur earlier in nCRT patients and overall survival after recurrence is significantly longer after primary surgery.

Minimum number of lymph nodes to maximize survival in non-metastatic appendiceal adenocarcinoma

IntroductionIn non-metastatic appendiceal adenocarcinoma, the relationship between the number of lymph nodes harvested and overall survival is unknown. The objective of this study was to determine whether the number of lymph nodes harvested impacts survival in patients with mucinous and non-mucinous appendiceal cancer. MethodsRetrospective cohort analysis was conducted in patients who underwent surgery for appendiceal adenocarcinoma in the SEER database from 2000–2019. Exclusion criteria included patients without the number of regional nodes harvested/node positivity, missing survival data, stage IV disease, and certain subtypes of appendiceal tumors. The primary outcome was 10-year overall survival. ResultsA total of 1651 patients were identified, 1101 with mucinous and 550 with non-mucinous cancer. The majority of patients were male (54 %) and between the ages of 50–74 (52 %). Mean ± SD number of lymph nodes harvested was 17.04 ± 10.41. The ten-year survival rates for patients with mucinous appendiceal cancer were 43–74 % and 25–68 % for non-mucinous cancer, depending on AJCC stage. Multivariate Cox-regression analysis displayed that the number of lymph nodes harvested was an independent predictor of survival (p < 0.0001). The optimal threshold predicted by Cox-regression for maximal survival benefit was harvest of a minimum of 15 nodes for mucinous and 12 for non-mucinous cancer. Additionally, for mucinous cancer, per each additional 3 nodes harvested past 15, the 10-year risk of mortality decreased by 7 % (HR 0.93 (0.88 to 0.98), p < 0.001). ConclusionsThe number of lymph nodes harvested is an independent predictor of survival for patients with appendiceal adenocarcinoma. To maximize this survival benefit, a minimum of 15 regional lymph nodes must be harvested for mucinous and 12 for non-mucinous cancer.

Research on Asylum-Seeking Preschool Children In Turkey: A Systematic Review

This study was conducted with the systematic review method to determine the studies conducted on children who are asylum-seekers in preschool period in Turkey and their results. Systematic reviews are important research projects that should be conducted by examining all studies conducted on a certain subject within a certain protocol. For this reason, the current study was carried out with the studies searched in Google Scholar and YÖKTEZ database by using the keywords "asylum-seeking children", "asylum-seeking child", "refugee children", "refugee child" without any date restriction in the research process. While the inclusion criteria for the systematic review were determined as studies conducted with children in the 0-6 age group, the exclusion criteria were determined as studies on children over the age of 6. Because of the keywords determined, a total of 2039 studies were reached and all of them were analyzed one by one. From these studies, 43 studies that were suitable for the study were identified. After removing duplicate studies, 29 studies that met the inclusion and exclusion criteria were included. When the studies were analyzed, it was seen that the problem of asylum-seekers is not limited to adults. Children are most affected by this situation.

Spontaneous pneumomediastinum: A comprehensive review of diagnosis and management.

Pneumomediastinum is a rare condition defined by the presence of air in the mediastinum. In the absence of traumatic injury, iatrogenic injury, or clear etiology, it is called spontaneous pneumomediastinum (SPM). Spontaneous pneumomediastinum most commonly occurs in younger individuals and has a self-limiting course with a good outcome. The purpose of the present manuscript is to systematically review the existing literature on SPM evaluation and management for updated clinical understanding of this condition. A literature search was conducted of publications about SPM on MEDLINE/PubMed and Google Scholar by identifying all the articles with key search terms "pneumomediastinum" and "spontaneous pneumomediastinum". Inclusion criteria were case series published in English between 1980 and 2023. In total, 24 case series were selected and reviewed to determine presenting symptoms, clinical signs and predisposing factors associated with spontaneous pneumomediastinum. Most patients were male; the average age at diagnosis was 26.3 years. The most common presenting symptoms were chest pain and dyspnea. The most common exam finding was subcutaneous emphysema, in 35.4% of patients. Only 5.9% had the classic Hamman's sign. Risk factors include history of asthma, history of smoking, and recent physical activity. This manuscript presents an extensive review of relevant literature highlighting the diagnosis and essential management of spontaneous pneumomediastinum.

Effect of Micro-Credit on Micro Business Development among Women Entrepreneurs

Women have been recognized as key contributors toward livelihood and poverty eradication, especially in developing countries. Hence, entrepreneurs planning to start their own businesses rely on microfinance as a source of resources for their micro businesses. Therefore, the study examines the effect of micro-credit on micro business development among women entrepreneurs. However, the methodology of the study is based on the results of the previous studies, hence, inclusive criteria were used; therefore, the paper is conceptual in nature. Moreover, the study found that there is a significant positive effect of micro-credit on microbusiness development among women entrepreneurs. The implication of the result is therefore positive on the micro business development, the more women businesses are using micro-credit the more their development and vice versa. The study concluded that a positive relationship between micro-credit and business development among women entrepreneurs. Based on the findings, the study recommends that women micro businesses should introduce the use of microcredit to expand their businesses while employing different phases of accountability as well as treating the business as a separate entity with the owner in order to protect the loan liability that the business is entitled to pay as at when due.

Validation of the Japanese version of the scales of the attitudes toward people with epilepsy (SAPE-J).

The aims of this study were to translate the SAPE questionnaire (Scales of the Attitudes toward People with Epilepsy) questionnaire developed in Germany that assesses attitudes toward people with epilepsy (PWE) into Japanese and to examine its reliability and validity. We crafted the Japanese version of SAPE (SAPE-J) by drawing upon the original German version. On May 22nd and 23rd, 2023, we surveyed the general public registered with an online research survey service (Cross Marketing Group Inc., Tokyo, Japan) using an online questionnaire. Inclusion criteria were an age of ≥18 years, sufficient reading and speaking skills in Japanese, and the ability to comprehend the Japanese questionnaires. In addition to the translated SAPE-J, we asked about knowledge of epilepsy, personal experience with epilepsy, and gathered information about age, gender, employment status, education level, marital status, and household income in accordance with the validation of the German version of the SAPE. 400 adults from the general public who had heard or read about epilepsy were asked to participate, granted informed consent, and completed the study questionnaire. The SAPE-J questionnaire has 6 scales: 1. Social Distance; 2. Stereotypes; 3. Concerns when encountering a person with epilepsy (PWE) and emotional reactions differentiated by 4.1 Fear, 4.2. Anger, and 4.3 Pity; with a total of 26 items. The reliability of these scales ranged between acceptable to high (Cronbach's alpha 0.74-0.92) and confirmatory factor analyses (CFA) confirmed the presumed six-factor structure of the SAPE (factorial validity). Multivariate generalized linear models (GLM) were used to investigate the construct validity and showed that, depending on subscale, different variables such as age, gender, education level, personal contact to PWE, and epilepsy specific knowledge were significant predictors of attitudes. The Japanese version of the SAPE proved reliable and valid for assessing attitudes toward PWE in the Japanese public. Increasing understanding about how to deal with and accept persons with epilepsy may help reduce negative attitudes and fears about the condition. The study translated the German SAPE questionnaire, which measures attitudes toward people with epilepsy (PWE), into Japanese and tested its reliability and validity. The Japanese version (SAPE-J) was created and surveyed online among 400 adults in Japan. The SAPE-J has 6 scales covering social distance, stereotypes, and emotional reactions like fear, anger, and pity. Reliability was high (Cronbach's alpha 0.74-0.92), and factor analyses confirmed its structure. The study found age, gender, education, and personal contact with PWE influenced attitudes. The SAPE-J is reliable and valid for assessing attitudes toward PWE in Japan, potentially reducing negative views and fears about epilepsy.

PERCEPTION OF FEMALE COLLEGE STUDENTS ABOUT MENSTRUAL HYGIENE IN JHAJJAR, HARYANA: A SURVEY STUDY

Background: In Indian society, menstruation is often considered impure and there is a lack of knowledge about it among adolescent girls. Proper menstrual hygiene practices, such as using sanitary pads and washing the genital area, are essential. However, due to social stigma and lack of access to affordable products and facilities, many girls miss school or work during their periods. It is crucial to break the taboo surrounding menstruation and educate both girls and boys about it. This will lead to improved physical health and greater participation in daily life, resulting in a more inclusive and equal society. Objectives:The objective of this study is to understand the perception and awareness of menstrual hygiene among female college students in Jhajjar, Haryana. Design: Questionnaire based survey study. Method: The study sample consisted of 300 subjects. The subjects were selected as per the inclusive criteria and information was provided to the subjects. Consent form was obtained from the subjects. Questionnaire was given to subjects and filled questionnaire was collected. After collecting the necessary data through the questionnaire, it was compiled and analyzed using suitable statistical methods. Result: According to the result obtained most of the females have proper knowledge regarding sanitary material. A majority of females re-change their sanitary material more than twice. Whereas washing hands and cleanliness practices were found to be unsatisfactory. Conclusion: From the result of this study we have concluded that females have proper knowledge about sanitary material but they dont have enough knowledge about washing and cleaning habits due to which they can be vulnerable toward many infections and diseases.

Investigating precise control pathway for haemostatic clip usage in laparoscopic cholecystectomy based on patient clinical variations: an exploratory retrospective observational study

ObjectivesTo explore a precise control pathway based on patient clinical variations for haemostatic clip usage in laparoscopic cholecystectomy (LC) through on-site research data from a teaching hospital. Specifically, the study...

The Relationship between Anxiety Level and Cognitive Function of Students Class of 2022 Medical Faculty of Universitas Palangka Raya in Dealing with OSCE

Anxiety is a feeling that is often felt in dealing with various life situations that occur to a person. This can also happen to new students taking the Objective Structured Clinical Examination (OSCE). Anxiety that is continuously experienced by students will disrupt their sleep patterns, and lack of sleep results in poor sleep quality which can affect the cognitive and psychomotor aspects of medical students. This study aims to determine the relationship between anxiety levels and students' cognitive function in dealing with OSCE. This research is a cross-sectional study, where the research subjects are students from the class of 2022 who meet the exclusion and inclusion criteria. The research was conducted in June 2023 at the Faculty of Medicine, University of Palangka Raya. This research was conducted on 135 subjects consisting of 41 men and 94 women with an average age of 19(17-21) years. The highest anxiety level before the OSCE exam in the study was a moderate anxiety level of 75.5%. There is no significant relationship between anxiety level (ZSAS score) and cognitive function (Moca-Ina) with p=0.680. In conclusion, there is no relationship between anxiety level and students' cognitive function in dealing with OSCE.

PENGARUH MEDIA EDUKASI VIDEO TERHADAP PENGETAHUAN IBU TENTANG DIARE DI DUSUN JUMENENG KIDUL DESA SUMBERADI WILAYAH KERJA PUSKESMAS MLATI II

In the world, diarrhea is one of the main causes of death, recorded at 5-10 million/year. Lack of knowledge is one of the factors causing diarrhea. The study aimed to evaluate the effectiveness of videos as a health promotion medium regarding maternal knowledge about diarrhea. Quantitative research was conducted on 40 mothers according to inclusion and exclusion criteria with a pre-experimental design, one group pre-test and post-test, through accidental sampling. Intervention with video media about diarrhea in children, with measuring instruments in the form of questionnaires. Analysis uses the Wilcoxon test. Mothers' knowledge about diarrhea before the intervention had a median value of 31, while after the intervention it was 34. There was an influence of health education with videos on respondents' knowledge about diarrhea with p value = 0.000 &lt; 0.05). Video media optimizes mothers' knowledge about diarrhea.

Influence of digital technologies on adolescents: a literature review

Objectives: To identify factors in digital information and communication devices that affect adolescents. Methods: A literature review was conducted involving research and analysis in a scientific database. Using inclusion and exclusion criteria, 8 articles were selected, providing significant insights into the topic. Results: The research, reading, and analysis of the obtained results highlighted four main themes: "Side effects of digital technology in adolescence"; "Adolescence shaped by digital technology"; "Digital adolescence: a call for further research"; and "Digital technology: not all thorns". Bardin's recommendations guided the systematic approach of this research. Final considerations: The study reveals various factors influencing behavior and potential risks to the mental health of adolescents as users of digital information and communication Technologies

Effect of Long-Term Debt on Financial Performance of Cement Manufacturing Companies

Due to its critical role in overall economic development, the cement industry is identified as one of the areas of the first and second Growth and Transformation Plan (GTP) as a sector of special consideration. However, the main objective of this study is to examine the effect of long-term debt on financial performance in cement manufacturing companies. Moreover, the specific objectives include; examining the effect of long-term debt on return on assets in cement manufacturing companies, also, to examine the effect of long-term debt on return on equity in cement manufacturing companies, in addition, the study identifies two financial performance measures which include; return on assets and return on equity, and directly considered with the relationship of long-term debt. The methodology of this study is exclusive criteria; because the study reviewed only recent studies from 2019-2023 that reported on long-term debt and financial performance. The data is gathered through the means of review and analyzed through identifying the outcome of the reviewed studies. Therefore, based on the majority, the study found a significant negative influence of long-term debt (LTD) on financial performance measured by return on assets (ROA) of cement manufacturing companies and also, a negative effect was found with the financial performance measured by return on equity (ROE) of cement manufacturing companies. In line with the findings, the study concludes that there is a negative effect of long-term debt on financial performance measured by both the (ROA and ROE) of cement manufacturing companies. Similarly, the study recommends that cement manufacturing companies avoid the use of debt in financing their assets; also, the cement manufacturing companies should also focus much on internal financing so as to improve shareholder returns.

Opportunities for nurses aspiring to or undertaking clinical academic development globally: protocol for a scoping review

IntroductionNurse researchers often lack awareness of how to start a clinical academic research career and often lack clear entry routes. This scoping review aims to identify the range and nature...

Natural History and Longitudinal Outcomes of Patients with Mild-to-Moderate Ulcerative Proctitis or Ulcerative Proctosigmoiditis: A Single-Center, Retrospective Study.

Ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS) are special forms of ulcerative colitis. The disease burdens of UP and UPS are increasing. However, the natural history and prognosis of patients with mild-to-moderate UP or UPS have been poorly studied. The aim of this study is to evaluate the characteristics, short-term and long-term outcomes of patients with mild-to-moderate UP or UPS followed at a single center over a period of 3years. A retrospective study of patients with UP and UPS followed at a single center from 2021 to 2023 was performed. After scanning for inclusion and exclusion criteria, patient demographics and clinical data were collected. Disease severity was accessed by Myao endoscopy scores and ulcerative colitis endoscopic index of severity. Endoscopic improvement was defined as decreased scores at the last follow-up. Disease extension was defined as endoscopic evidence of a greater extent of disease at the last follow-up. A total of 414 patients were included for evaluation, of which 292 patients (70.53%) were at mild disease stage, and 122 patients (29.47%) had moderate diseases. At the last follow-up, 315 patients (76.09%) showed endoscopic improvement, and 247 patients (59.66%) showed endoscopic remission. An overall extension rate of 11.11% was observed at the last follow-up. Subgroup analysis revealed a better prognosis in younger patients. The disease extension rate was higher in moderate group and symptomatic patients. Promising outcomes were observed in patients with mild-to-moderate ulcerative proctitis or ulcerative proctosigmoiditis. Disease severity and symptoms are correlated with the risk of extension.

Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data.

Safety analyses play a pivotal role in drug development, ensuring the protection of patients while advancing innovative pharmaceuticals to market. A single study generally does not have sufficient sample size to evaluate all important safety events with reasonable precision and may not cover the full target population for the investigational treatment. Integrated analyses (pooled or meta-analysis) over several studies may be helpful in that regard. But without a structured conscious workflow accompanied with appropriate statistical methods for the integrated analysis, this can easily take a route compromising the interpretation. In this article we apply the ICH estimand framework to clinical trial integration and summarize respective critical statistical assumptions to ensure the integrated analyses are interpretable. The estimand framework is valuable for developing principles for a deeper understanding of the critical statistical aspects of planning an integrated safety analysis. Our principles address the clinical question of interest, estimand and estimation. Special focus was given to the criteria for inclusion and exclusion of the component studies in the integrated analysis, and to integration of estimates pertaining to signal detection. Performing an integrated analysis and its preparatory steps calls for a good understanding of the clinical question of interest and its estimand, care and sound practice, to enable interpretation and avoid introducing unnecessary bias. It is valuable to use the estimand framework not only for efficacy evaluations, but also for safety evaluations in clinical trials and for integrated safety analyses.

Dissecting and fusiform aneurysms of the superior cerebellar artery: anatomy, clinical presentation, and treatment outcomes.

The management of superior cerebellar aneurysms is still controversial. Although several techniques are available, the deep localization of the lesion and the limited number of cases increase the complexity of decision-making for optimal treatment. Only a few cases of dissecting and fusiform aneurysms of the superior cerebellar artery (SCA) are described in the literature, many of which are without long follow-ups. The study aims to offer an exhaustive retrospective analysis of patients affected by SCA fusiform and dissecting aneurysms treated at our institution from 2008 to 2023, highlighting outcomes and complications. Moreover, a comprehensive narrative review was performed. A total of seven patients were treated at our institution. After a title and abstract screen, fifty-five papers met the criteria for inclusion in the review. In our case series, conservative treatment was proposed as the first therapeutic option in four cases (57.1%), while endovascular treatment (EVT) was in three cases (42.9%). A good recovery was observed in 66% of patients presenting with subarachnoid hemorrhage (SAH), while every patient without SAH achieved a good clinical outcome. A poor outcome was observed only in one patient with a dissecting aneurysm causing SAH, who also suffered a pontine infarction. In the literature review, conservative treatment was proposed as a first therapeutic option in eleven cases (16.6%), open microsurgical techniques in 19 patients (28.8%), and EVT in 31 patients (46.9%). Fatal outcome was documented in five patients (7.5%), all characterized by the rupture of the vascular lesion, while 6.1% of cases had non-fatal poor outcomes.