Analysis of outcomes of robot-assisted laparoscopic pyeloplasty in children from a tertiary pediatric center in South India.

Aim: This study aims to analyze the outcomes of robot-assisted laparoscopic pyeloplasty (RALP) in children with pelvi-ureteric junction obstruction (PUJO) over a 10-year period at a tertiary care center in South India. Methods: This study provides a detailed analysis of prospectively acquired data from 2013 to 2023 of all children who underwent RALP at our institution. Pre- and post-operative renal ultrasound and isotope renography were used to assess outcomes. Detailed information on patient demographics, procedural duration, post-operative pain relief, operation steps, and post-surgical follow-up protocols has been provided. The analysis included all patients who completed a 1-year follow-up. Result: Between 2013 and 2023, 201 children underwent RALP. Of these, 185 children completed at least 1 year of follow-up and were included in the analysis. The mean age of the cohort was 4.9 years (1 month to 17 years), with males comprising the majority (77.3%). Twenty-five children (13.5%) were younger than 1 year of age. Left-sided PUJO was found to be more common. The mean console time was 76.5 min (40-180 min), and the average hospital stay was 2.8 days (2-5). After surgery, the mean reduction in antero-posterior diameter of the renal pelvis was more than 50% of its pre-operative value and statistically significant (3.3 ± 0.3 to 1.9 ± 0.9 cm). At the end of 1 year, the overall reduction in renal size was also significant (9.7 ± 2.3 cm pre-operative to 8.9 ± 1.8 cm post-operative). The pre-operative Society of Fetal Urology (SFU) grade of hydronephrosis was compared to the post-operative SFU grade, and the improvement (resolution/downgrading) was found to be statistically significant. The median split renal function in this series was 39% pre-operative and 43% post-operative, and the overall functional improvement after RALP was significant. A successful outcome was observed in 181 children (97.8%). Four children experienced persistent severe hydronephrosis and underwent redo stenting and/or redo pyeloplasty (2.1% failure rate). Post-operative complications, according to the Clavien-Dindo classification, were classified as type 1 in three children and type 3b in two children. There were no conversions to open surgery in the series. Conclusion: RALP emerges as the minimally invasive procedure of choice for children with PUJO at our institution. It is safe, delivering consistently excellent results and minimal complications. Our outcomes are comparable to those of previously published series. We trust that our experience will serve as a roadmap for those centers (especially in South Asia) embarking on a pediatric robotic program.

Long-term outcomes of adults with FSGS in the German Chronic Kidney Disease cohort.

Background: Focal segmental glomerulosclerosis (FSGS) can lead to kidney failure in adults. This study examines the progression of FSGS in the German Chronic Kidney Disease (GCKD) cohort. Methods: The GCKD study (N = 5217), a prospective cohort, included 159 patients with biopsy-confirmed FSGS recruited from 2010 to 2012. Baseline was defined as the first study visit. Adjudicated endpoints included a composite kidney endpoint (CKE), including an estimated glomerular filtration rate (eGFR) decrease >40%, eGFR <15 ml/min/1.73 m2 or initiation of kidney replacement therapy and combined major adverse cardiovascular events (MACE), including non-fatal myocardial infarction or stroke and all-cause mortality. Associations between baseline demographics, laboratory data, comorbidity and CKE and MACE were analysed using the Cox proportional hazards regression model. Results: The mean age at baseline was 52.1 ± 13.6 years, with a disease duration of 4.72 years (quartile 1: 1; quartile 3: 6) before joining the study. The median urinary albumin:creatinine ratio (UACR) at baseline was 0.7 g/g (IQR 0.1;1.8), while mean eGFR was 55.8 ± 23 ml/min/1.73 m2. Based on clinical and pathological features, 69 (43.4%) patients were categorized as primary FSGS, 55 (34.6%) as secondary FSGS and 35 (22%) as indeterminate. Over a follow-up of 6.5 years, 44 patients reached the composite kidney endpoint and 16 individuals had at least one MACE. UACR ≥0.7 g/g was strongly associated with both the composite kidney endpoint {hazard ratio [HR] 5.27 [95% confidence interval (CI) 2.4-11.5]} and MACE [HR 3.37 (95% CI 1.05-10.82)] compared with <0.7 g/g, whereas a higher eGFR at baseline (per 10 ml/min) was protective for both endpoints [HR 0.8 (95% CI 0.68-0.95) and HR 0.63 (95% CI 0.46-0.88), respectively]. Patients with secondary FSGS experienced a greater rate of eGFR decline than patients with primary FSGS. Conclusions: Lower eGFR and higher albuminuria are key risk factors for kidney disease progression and cardiovascular events in patients with FSGS.

The efficacy of simple oral nutritional supplements versus usual care in postoperative patients with gastric cancer: study protocol for a multicenter, open-label, parallel, randomized controlled trial.

BACKGROUND: Body weight loss (BWL) after gastrectomy impact on the short- and long-term outcomes. Oral nutritional supplement (ONS) has potential to prevent BWL in patients after gastrectomy. However, there is no consistent evidence supporting the beneficial effects of ONS on BWL, muscle strength and health-related quality of life (HRQoL). This study aimed to evaluate the effects of ONS formulated primarily with carbohydrate and protein on BWL, muscle strength, and HRQoL. METHODS: This will be a multicenter, open-label, parallel, randomized controlled trial in patients with gastric cancer who will undergo gastrectomy. A total of 120 patients who will undergo gastrectomy will be randomly assigned to the ONS group or usual care (control) group in a 1:1 ratio. The stratification factors will be the clinical stage (I or ≥ II) and surgical procedures (total gastrectomy or other procedure). In the ONS group, the patients will receive 400 kcal (400 ml)/day of ONS from postoperative day 5 to 7, and the intervention will continue postoperatively for 8 weeks. The control group patients will be given a regular diet. The primary outcome will be the percentage of BWL (%BWL) from baseline to 8 weeks postoperatively. The secondary outcomes will be muscle strength (handgrip strength), HRQoL (EORTC QLQ-C30, QLQ-OG25, EQ-5D-5L), nutritional status (hemoglobin, lymphocyte count, albumin), and dietary intake. All analyses will be performed on an intention-to-treat basis. DISCUSSION: This study will provide evidence showing whether or not ONS with simple nutritional ingredients can improve patient adherence and HRQoL by reducing BWL after gastrectomy. If supported by the study results, nutritional support with simple nutrients will be recommended to patients after gastrectomy for gastric cancer. TRIAL REGISTRATION: jRCTs051230012; Japan Registry of Clinical Trails. Registered on Apr. 13, 2023.

Pregnancy Outcomes Among Teenagers at a National Referral Hospital in Uganda.

Introduction: Teenage pregnancy is a global public health challenge, and it is a major contributor to the high maternal and neonatal morbidity and mortality rates reported in sub-Saharan Africa and Uganda. However, there is a paucity of data regarding pregnancy outcomes and their associated factors among teenagers in Uganda. The purpose of this study was to determine the prevalence and factors associated with pregnancy outcomes among teenagers who delivered at a National Referral Hospital in Kampala, Uganda. Materials and Methods: This cross-sectional study was conducted among teenage mothers who delivered at a National Referral Hospital in Kampala, Uganda. Consecutive participant recruitment was done for those who fulfilled the eligibility criteria. The outcomes of interest included adverse maternal outcome with obstructed labor being used as a proxy and adverse fetal outcomes with birth asphyxia used as a proxy. Logistic regression analysis was used to determine the association between independent and dependent variables with a 5% level of statistical significance (α = 0.05). Results: Teenage pregnancy was associated with adverse maternal outcomes which included obstructed labor (18%) and preterm labor (5.5%). There were no maternal deaths during the study period. Adverse fetal outcomes observed in this study population included low birth weight (83%), birth asphyxia (18%), and stillbirth (4%). The only factor associated with adverse maternal outcome was gestational age where teenage mothers had 4 times likelihood of delivering before 37 weeks. Relatedly, teenage mothers had an 81% chance of having a preterm birth. Conclusion: Teenage pregnancy was generally not associated with adverse maternal or fetal outcomes except for preterm birth. The reasons for adverse pregnancy outcomes may reflect a combination of gynecological and biological immaturity, as well as adverse socioeconomic pressures.

Successful Preoperative Transjugular Intrahepatic Portosystemic Shunt for Portal Decompression in Patients With Inflammatory Bowel Disease and Cirrhosis Requiring Surgical Intervention.

Background: Colorectal surgery in patients with inflammatory bowel disease (IBD) and cirrhosis has increased morbidity, which may preclude surgery. Preoperative transjugular intrahepatic portosystemic shunt (TIPS) is postulated to reduce surgical risk. In this retrospective single-center study, we characterized perioperative outcomes in patients with IBD and cirrhosis who underwent preoperative TIPS. Methods: We identified patients with IBD and cirrhosis who had undergone preoperative TIPS for portal decompression between 2010 and 2023. All other indications for TIPS led to patient exclusion. Demographic and medical data were collected, including portal pressure measurements. Primary outcome of interest was perioperative outcomes. Results: Ten patients met the inclusion criteria. The most common surgical indications were dysplasia (50%) and refractory IBD (50%). TIPS was performed at a median of 47 days (IQR 34-80) before surgery, with reduction in portal pressures (22.5 vs. 18.5 mmHg, P < .01) and portosystemic gradient (12.5 vs. 5.5 mmHg, P < .01). Perioperative complications occurred in 80% of patients, including surgical site bleeding (30%), wound dehiscence (10%), systemic infection (30%), liver function elevation (50%), and coagulopathy (50%). No patients required re-operation, with median length of stay being 7 days (IQR 5.5-9.3). The 30-day readmission rate was 40%, most commonly for infection (75%), with 2 patients having intra-abdominal abscesses and 1 patient with concern for bowel ischemia. Ninety-day and one-year survival was 100% and 90%, respectively. Patients with primary sclerosing cholangitis (PSC)-cirrhosis were noted to have higher perioperative morbidity and a 30-day readmission rate. Conclusions: In patients with IBD and cirrhosis, preoperative TIPS facilitated successful surgical intervention despite heightened risk. Nevertheless, significant complications were noted, in particular for patients with PSC-cirrhosis.

Healthcare Encounters and Outcomes of Filipino Patients with Systemic Lupus Erythematosus Managed at a Tertiary COVID-19 Referral Center.

Objective: The coronavirus disease 2019 (COVID-19) pandemic has limited healthcare delivery for patients with chronic diseases, including Systemic Lupus Erythematosus (SLE). This study aims to describe the outcomes of patients with SLE in a national COVID-19 referral center in the Philippines. Methods: A review of records of all adult patients with SLE seen in the University of the Philippines-Philippine General Hospital (UP-PGH) from March 2020 to December 2021 was done. Data about patient characteristics, health encounters, and outcomes before and after the first visit during the study period were extracted. Descriptive statistics were employed. Results: Our population of 403 patients was predominantly young (mean age 34.53 ± 11.14 years), female, and unemployed. This consisted of 370 known cases of SLE, 92 were diagnosed in institutions outside UP-PGH, and 33 new patients. Over the 22-month study period, there were 2,093 medical encounters, most of which were teleconsultations (81.70%). During an average gap of 53.6 ± 26.7 weeks between the last consultation and the first visit within the pandemic study period, 84 patients (22.70%) discontinued at least one of their SLE control medications, 68 (18.38%) patients developed a lupus flare, and 79 (21.35%) were hospitalized for various reasons. On their return to the rheumatology clinic during the pandemic, 37.47% were in lupus flare, 28.29% needed to be hospitalized, and 20 died. However, 86.75% of flares were controlled. During subsequent health encounters, 48 patients had a new flare (43 of these were controlled) and 20 died. The most common reason for hospitalization (n=160) was lupus disease flare and the most common cause of death (n=40) was pneumonia. Sixty patients acquired COVID-19 infection from which most recovered and four died. Conclusion: Audio teleconsultation was the most common method used by our lupus cohort to interact with their doctors during the pandemic. There was an average of a year-long interruption in medical care for 62.70%. More than a third developed a disease flare and 15% acquired COVID-19 but outcomes were good in more than 85%. Despite the challenges posed by the pandemic, the majority of our lupus cohort who were able to continue their treatment had favorable outcomes.

Alliance for Scientific Autism Intervention: System Components and Outcome Data from High-Quality Service Delivery Organizations.

Promoting excellence in autism intervention is arguably more urgent than ever for the field of applied behavior analysis. To fulfill this objective, autism agencies must operate from validated program systems and do so with fidelity. Program components include, but are not limited to, staff training and evaluation of clinical skills, functional personnel roles designed to promote positive outcomes for those served, and professional staff-communication-skill repertoires. Data on client outcomes must be tied to implementation of core program variables; and, contingencies between the data on client outcomes and staff performance must exist. Furthermore, these contingencies must be yoked across members of the organization to ensure a sustainable and effective program model. Finally, data on consumer satisfaction must be collected and used to evaluate program components and agency practices. Members of the Alliance for Scientific Autism Intervention have implemented key program-wide systems based upon the work of McClannahan and Krantz Journal of Applied Behavior Analysis, 26, 589-596 (1993) for decades and across various agency cultures. Data collected by six independent educational agencies on client outcomes, program implementation, and consumer feedback for a 10-year time span demonstrate the sustainability of the model and support the importance of key organizational systems and the relationship between implementation of the model and high-quality outcomes for individuals with autism.

Descriptive Analysis of Health Disparities Between Black and White People With Multiple Sclerosis in the Deep South.

BACKGROUND: Black people with multiple sclerosis (MS) have a worse disease course and higher rates of progression than White people with MS. Contributing factors to health disparities are understudied. METHODS: Data were collected retrospectively from the electronic medical records of 500 people with MS treated between 2013 and 2022 at a university comprehensive MS center in a southern state. Multiple logistic regression analyses were used to determine the associations between 2 disability outcomes (ie, low vs high Expanded Disability Status Score [EDSS] and ambulatory assistance [AMB] requirements) and age, sex, body mass index (BMI), MS type, disease duration, hypertension status, diabetes status, smoking status, adjusted gross income, and health insurance type for Black people with MS and White people with MS. RESULTS: Of the cohort, 39.2% identified as Black people with MS and the rest were White people with MS. Approximately 80% of White people with MS had relapsing MS (RMS) vs almost 90% of Black people with MS. Black people with MS were more likely to have a higher EDSS (OR 5.0, CI 3.0-8.4) and AMB (OR, 2.8; 95% CI, 1.6-4.8) than White people with MS. Among White people with MS, women (OR, 0.5; 95% CI, 0.3-0.9) and people with RMS (OR, 0.13; 95% CI 0.06-0.3) were less likely to have higher EDSS scores. Among Black people with MS, neither female sex nor RMS status was associated with a lower risk of having a higher EDSS (OR, 0.685; P = .43 and OR, 0.394; P = .29, respectively). CONCLUSIONS: The disparity in disability outcomes between Black people with MS and White people with MS may be driven by more disabling courses for Black people with RMS and by female sex, though further study is needed to determine causes for this outcome.

Mediterranean diet improves blastocyst formation in women previously infected COVID-19: a prospective cohort study.

Objectives: Our study tries to investigate the effect of the Mediterranean diet (MeDiet) on assisted reproductive treatment outcomes in women after COVID-19 infection. Design: A prospective observational cohort study in the Reproductive and Genetic Hospital of CITIC-Xiangya from February 2023 to August 2023.Subjects: A total of 605 participants previously infected with COVID-19 were enrolled. Exposure: None. Main outcome measurement: The primary outcomes are oocyte and embryo quality. The secondary outcomes are pregnancy outcomes. Results: A majority of participants (n = 517) followed low to moderate MeDiet, and only a small group of them (n = 88) followed high MeDiet. The blastocyst formation rate is significantly higher in MeDiet scored 8-14 points women (46.08%), compared to the other two groups (which is 41.75% in the low adherence population and 40.07% in the moderate adherence population respectively) (p = 0.044). However, the follicle number on hCG day, yield oocytes, normal fertilized zygotes, fertilization rate, day three embryos (cleavage embryos), and embryo quality are comparable among the three groups. For those who received embryo transfer, we noticed an obvious trend that with the higher MeDiet score, the higher clinical pregnancy rate (62.37% vs. 76.09% vs. 81.25%, p = 0.197), implantation rate (55.84% vs. 66.44% vs. 69.23%, p = 0.240) and ongoing pregnancy rate (61.22% vs. 75.00% vs. 81.25%, p = 0.152) even though the p values are not significant. An enlarging sample size study, especially in a high adherence population should be designed to further verify the effects of MeDiet's role in improving IVF performance. Conclusion: High adherence to MeDiet is associated with improved blastocyst formation in women after COVID-19 infection. There is also a trend that high adherence to MeDiet might be beneficial to clinical pregnancy, embryo implantation as well as ongoing pregnancy in these women.

Effect of Elevated Neutrophil-to-Lymphocyte Ratio on Adverse Outcomes in Patients With Myocardial Infarction: A Systematic Review and Meta-Analysis.

Myocardial infarction (MI), a leading cause of morbidity and mortality globally, is characterized by an underlying inflammatory process driven by atherosclerosis. The neutrophil-to-lymphocyte ratio (NLR), a readily available and cost-effective marker of systemic inflammation, has emerged as a potential predictor of adverse outcomes in patients with MI. This meta-analysis aimed to evaluate the association between elevated NLR and the risk of major adverse cardiovascular events (MACE) and all-cause mortality in patients with MI. A comprehensive literature search was conducted across multiple databases, including Embase, Web of Science, PubMed, and OVID Medicine, to identify relevant studies published from January 1, 2011, onward. Studies reporting the effect of NLR values on MACE and mortality in adult patients with MI, including both ST-elevation (STEMI) and non-ST-elevation (NSTEMI) subtypes, were included. Data extraction and quality assessment were performed independently by multiple authors. The meta-analysis included 37 studies, comprising a total of 18 studies evaluating the risk of MACE and 30 studies assessing all-cause mortality. The pooled analysis revealed a significantly increased risk of MACE (odds ratio [OR] 1.86, 95% confidence interval [CI] 1.53-2.28, P < 0.01) and all-cause mortality (OR 2.29, 95% CI 1.94-2.70, P < 0.01) in patients with elevated NLR compared to those without elevated NLR. Subgroup analyses stratified by follow-up duration and study design further supported the consistent association between elevated NLR and adverse outcomes. In conclusion, this meta-analysis demonstrates a significant association between elevated NLR and an increased risk of MACE and all-cause mortality in patients with MI. These findings highlight the potential clinical utility of NLR as a prognostic marker and underscore the importance of further research to validate its predictive value and establish optimal cutoff values for risk stratification in this patient population.

Postoperative Infection Following Hip Arthroscopy in Patients Receiving Preoperative Intra-articular Injections: A Systematic Review and Meta-Analysis.

Intra-articular injections prior to hip arthroscopy are often used to diagnose and conservatively manage hip pathologies, such as femoroacetabular impingement, labral tears, and chondral lesions. As a diagnostic tool, the relief of hip pain following an intra-articular injection helps pinpoint the primary source of pain and assists surgeons in recommending arthroscopic intervention for underlying intra-articular pathologies. However, when injections are not sufficiently spaced apart in time prior to hip arthroscopy, there is an elevated risk of postoperative infection. This systematic review aims to assess whether preoperative intra-articular injections prior to hip arthroscopy are associated with an increased risk of postoperative infection and to determine the safety timeframe for administering such injections prior to the procedure. A comprehensive search was conducted in the PubMed, Embase, and Cochrane Library databases to identify studies examining the relationship between preoperative intra-articular injections and postoperative infection following hip arthroscopy. A meta-analysis was conducted to compare the risk of infection between patients who received injections prior to hip arthroscopy at varying intervals and those who did not receive any preoperative injections. Five studies were included (four level III and one level IV), which consisted of 58,576 patients (58.4% female). Injections administered anytime prior to hip arthroscopy posed a significantly higher risk of infection compared to no history of prior injections (risk ratio: 1.45, 95% confidence interval: 1.14-1.85, P = 0.003). However, upon subanalysis, the risk of infection was significantly higher among patients who received injections within three months prior to hip arthroscopy compared to those who did not receive injections (risk ratio: 1.55, 95% confidence interval: 1.19-2.01, P = 0.001). Additionally, no significant difference in infection risk was observed when injections were administered more than three months before hip arthroscopy compared to no injections (risk ratio: 1.05, 95% confidence interval: 0.56-1.99, P = 0.87). The findings suggest that patients undergoing hip arthroscopy who have previously received intra-articular injections may face a statistically higher risk of postoperative infection, particularly when the injection is administered within three months prior to hip arthroscopy. Consequently, surgeons should exercise caution and avoid administering intra-articular injections to patients scheduled for hip arthroscopy within the subsequent three months to mitigate the increased risk of infection.

Outcomes of Laparoscopic Suture Rectopexy Versus Laparoscopic Mesh Rectopexy: A Systematic Review and Meta-Analysis.

The contemporary literature provides conflicting evidence regarding the precedence of laparoscopic mesh rectopexy over laparoscopic suture rectopexy for full-thickness rectal prolapse. This study aimed to compare the clinical outcomes of mesh and suture rectopexy to improve the surgical management of complete rectal prolapse. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed to extract studies based on mesh versus suture rectopexy and published from 2001 to 2023. The articles of interest were obtained from PubMed Central, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Journal Storage (JSTOR), Web of Science, Embase, Scopus, and the Cochrane Library. The primary outcomes included rectal prolapse recurrence, constipation improvement, and operative time. The secondary endpoints included the Cleveland Clinic Constipation Score, Cleveland Clinic Incontinence Score, intraoperative bleeding, hospital stay duration, mortality, overall postoperative complications, and surgical site infection. A statistically significant low recurrence of rectal prolapse (odds ratio: 0.41, 95% confidence interval (CI) 0.21-0.80; p=0.009) and longer mean operative duration (mean difference: 27.05, 95% CI 18.86-35.24; p<0.00001) were observed in patients with mesh rectopexy versus suture rectopexy. Both study groups, however, had no significant differences in constipation improvement and all secondary endpoints (all p>0.05). The laparoscopic mesh rectopexy was associated with a low postoperative rectal prolapse recurrence and a longer operative duration compared to laparoscopic suture rectopexy. Prospective randomized controlled trials should further evaluate mesh and suture rectopexy approaches for postoperative outcomes to inform the surgical management of complete rectal prolapse.

Improving outcomes of type 2 diabetes mellitus patients in primary care with Chronic Care Model: A narrative review.

Designed and implemented over two decades ago, the Chronic Care Model is a well-established chronic disease management framework that has steered several healthcare systems in successfully improving the clinical outcomes of patients with type 2 diabetes mellitus. Research evidence cements the role of the Chronic Care Model (with its six key elements of organization of healthcare delivery system, self-management support, decision support, delivery system design, clinical information systems, and community resources and policies) as an integrated framework to revamp the type 2 diabetes mellitus-related clinical practice and care that betters the patient care and clinical outcomes. The current review is an evidence-lit summary of importance of use of Chronic Care Model in primary care and their impact on clinical outcomes for patients afflicted with one of the most debilitating metabolic diseases, type 2 diabetes mellitus.

Causative Activities and Prognostic Factors of Open-Globe Injury: A Registry-Based City-Wide Multicentre Study.

PURPOSE: Traumatic globe injury is classified into closed-globe and open-globe injury (OGI); OGI leads to a worse prognosis. We aimed to identify causative activities and prognostic factors of OGI in a metropolitan city in South Korea. METHODS: This retrospective observational study used a prospective eye-injury registry conducted in Daegu, South Korea, between 1 August 2016 and 31 July 2021. We identified epidemiology and visual outcomes of OGI at four tertiary hospitals. Those with the best visual acuity lower than counting fingers at the 6-month follow-up were considered to have poor visual outcome. RESULTS: Of 9,208 patients with eye injuries, 282 had OGI. Most OGI patients were male (261, 92.6%), with the largest proportion in their 50s (76, 27.0%). The most frequent causative activity was mowing (59, 20.9%), and poor visual outcome was most seen in assault (7, 87.5%) and sports activity (9, 81.8%). Hammering, metal work, and sports activity were prevalent in those under 30, and mowing was most prevalent in those in their 50s (16, 21.1%) and 60s (29, 40.3%). In the multivariable logistic regression analysis, OGI related to traffic accident and sports activity were presented poor prognosis (adjusted odds ratio [aOR] 13.259, 95% confidence interval [CI] 1.202-146.205 for traffic accident; aOR 6.801, 95% CI 1.064-43.487 for sports activity). CONCLUSION: We need to develop advanced vehicle safety equipment, implement public education promoting seat belt usage and hazards of OGI, establish eye protection standards for key causal activities, and provide eye protection equipment for sports activities and mowing.

Comparing ventriculoatrial and ventriculopleural shunts in pediatric hydrocephalus: a Hydrocephalus Clinical Research Network study.

OBJECTIVE: When the peritoneal cavity cannot serve as the distal shunt terminus, nonperitoneal shunts, typically terminating in the atrium or pleural space, are used. The comparative effectiveness of these two terminus options has not been evaluated. The authors directly compared shunt survival and complication rates for ventriculoatrial (VA) and ventriculopleural (VPl) shunts in a pediatric cohort. METHODS: The Hydrocephalus Clinical Research Network Core Data Project was used to identify children ≤ 18 years of age who underwent either VA or VPl shunt insertion. The primary outcome was time to shunt failure. Secondary outcomes included distal site complications and frequency of shunt failure at 6, 12, and 24 months. RESULTS: The search criteria yielded 416 children from 14 centers with either a VA (n = 318) or VPl (n = 98) shunt, including those converted from ventriculoperitoneal shunts. Children with VA shunts had a lower median age at insertion (6.1 years vs 12.4 years, p < 0.001). Among those children with VA shunts, a hydrocephalus etiology of intraventricular hemorrhage (IVH) secondary to prematurity comprised a higher proportion (47.0% vs 31.2%) and myelomeningocele comprised a lower proportion (17.8% vs 27.3%) (p = 0.024) compared with those with VPl shunts. At 24 months, there was a higher cumulative number of revisions for VA shunts (48.6% vs 38.9%, p = 0.038). When stratified by patient age at shunt insertion, VA shunts in children < 6 years had the lowest shunt survival rate (p < 0.001, log-rank test). After controlling for age and etiology, multivariable analysis did not find that shunt type (VA vs VPl) was predictive of time to shunt failure. No differences were found in the cumulative frequency of complications (VA 6.0% vs VPl 9.2%, p = 0.257), but there was a higher rate of pneumothorax in the VPl cohort (3.1% vs 0%, p = 0.013). CONCLUSIONS: Shunt survival was similar between VA and VPl shunts, although VA shunts are used more often, particularly in younger patients. Children < 6 years with VA shunts appeared to have the shortest shunt survival, which may be a result of the VA group having more cases of IVH secondary to prematurity; however, when age and etiology were included in a multivariable model, shunt location (atrium vs pleural space) was not associated with time to failure. The baseline differences between children treated with a VA versus a VPl shunt likely explain current practice patterns.

U-PRO-CRM: designing patient-centred dose-finding trials with patient-reported outcomes.

BACKGROUND: Determining the maximum tolerated dose (MTD) remains the primary objective for the majority of dose-finding oncology trials. Whilst MTD determination often relies upon clinicians to identify dose-limiting toxicities (DLTs) experienced by patients during the trial, research suggests that clinicians may underreport patient's adverse events. Therefore, contemporary practice may be exposed to recommending intolerable doses to patients for further investigation in subsequent trials. There is increasing interest in patients self-assessing their own symptoms using patient-reported outcomes (PROs) in dose-finding trials. DESIGN: We present Utility-PRO-Continual Reassessment Method (U-PRO-CRM), a novel trial design which simultaneously uses clinician-rated and patient-rated DLTs (Clinician-DLTs and Patient-DLTs, respectively) to make dose (de-)escalation decisions and to recommend an MTD. U-PRO-CRM contains the published PRO-CRM as a special case and provides greater flexibility to trade-off the rate of Patient-DLTs and Clinician-DLTs to find an optimal dose. We present simulation results for U-PRO-CRM. RESULTS: For specified trade-offs between Clinician-DLT and Patient-DLT rate, U-PRO-CRM outperforms the PRO-CRM design by identifying the true MTD more often. In the special case where U-PRO-CRM generalises to PRO-CRM, U-PRO-CRM performs as well as its published counterpart. U-PRO-CRM minimises the number of patients overdosed whilst maintaining a similar proportion of patients allocated to the true MTD. CONCLUSIONS: By using a utility-based dose selection approach, U-PRO-CRM offers the flexibility to define a trade-off between the risk of patient-rated and clinician-rated DLTs for an optimal dose. Patient-centric dose-finding strategies, which integrate PROs, are poised to assume an ever more pivotal role in significantly advancing our understanding of treatment tolerability. This bears significant implications in shaping the future landscape of early-phase trials.

Short- and long-term effects of imatinib in hospitalised COVID-19 patients: A randomised trial.

OBJECTIVES: We studied the short- and long-term effects of imatinib in hospitalised COVID-19 patients. METHODS: Participants were randomised to receive standard of care (SoC) or SoC with imatinib. Imatinib dosage was 400mg daily until discharge (max 14 days). Primary outcomes were mortality at 30 days and 1 year. Secondary outcomes included recovery, quality of life and long COVID symptoms at 1 year. We also performed a systematic review and meta-analysis of randomised trials studying imatinib for 30-day mortality in hospitalised COVID-19 patients. RESULTS: We randomised 156 patients (73 in SoC and 83 in imatinib). Among patients on imatinib, 7.2% had died at 30 days and 13.3% at 1 year and in SoC 4.1% and 8.2% (adjusted HR 1.35, 95% CI 0.47-3.90). At 1-year, self-reported recovery occurred in 79.0% in imatinib and in 88.5% in SoC (RR 0.91, 0.78-1.06). We found no convincing difference in quality of life or symptoms. Fatigue (24%) and sleep issues (20%) frequently bothered patients at one year. In the meta-analysis, imatinib was associated with a mortality risk ratio of 0.73 (0.32-1.63; low certainty evidence). CONCLUSIONS: The evidence raises doubts regarding benefit of imatinib in reducing mortality, improving recovery and preventing long COVID symptoms in hospitalised COVID-19 patients.

Linking Patient-Reported Outcome Measure (PROM) Scores to Adverse Event Data to Gain Insight in Overestimation of Postoperative PROM Improvement after Total Hip Arthroplasty and Total Knee Arthroplasty Due to Selective Non-Response.

BACKGROUND: To gain insight into how clinically relevant improvement in Patient-Reported Outcome Measure (PROM) scores after Total Hip (THA) and Total Knee Arthroplasty (TKA) may be under- or overestimated, we compared PROM respondents and non-respondents on their adverse event rates and assessed whether adverse event occurrence was associated with clinically relevant PROM improvement from those without adverse events. METHODS: All primary THAs and TKAs performed in 19 Dutch hospitals between January 2017 and December 2019 were included. The Hip disability and Osteoarthritis Outcome Score-Physical function Short form (HOOS-PS) and Knee injury and Osteoarthritis Outcome Score-Physical function Short form (KOOS-PS) were used to assess the physical function after THA and TKA, respectively. Adverse events included 1-year revision, 30-day readmission, 30-day complications, and long (i.e., > 75th percentile) length-of-stay (LOS). A clinically relevant improvement was defined as at least a 10-point decrease in HOOS-PS and 9 points in KOOS-PS scores. Associations between adverse events and clinically relevant HOOS-PS and KOOS-PS improvement were assessed using binary logistic regression models adjusted for patient characteristics and clustering of patients within hospitals. RESULTS: There were 20,338 THA and 18,082 TKA procedures included. Adverse events mostly occurred more frequently in HOOS-PS and KOOS-PS non-respondents than in respondents. The THA patients experiencing revision, complications, or long LOS were less likely to experience clinically relevant HOOS-PS improvements (odds ratios of 0.11 [0.06 to 0.20], 0.44 [0.30 to 0.63], and 0.66 [0.50 to 0.88], respectively). The TKA patients experiencing revision or long LOS were less likely to experience clinically relevant KOOS-PS improvements (odds ratios of 0.26 [0.12 to 0.55] and 0.63 [0.50 to 0.80], respectively). CONCLUSION: Clinically-relevant HOOS-PS and KOOS-PS improvements are likely overestimated, as non-respondents had higher adverse event rates which were associated with lower likelihood to achieve clinically-relevant HOOS-PS and KOOS-PS improvements.

Evaluating learning outcomes of Christian religious education learners: A comparison of constructive simulation and conventional method.

Learning outcomes in Christian Religious Education (CRE) are attributed to the teaching and learning approaches utilized by teachers. In Kenya, conventional methods of teaching are prevalent in classrooms, as teachers often prefer methods that alleviate their workload. Nevertheless, the implementation of learner-centred methods such as constructive simulation enhances learning outcomes. Therefore, this research evaluated the dissimilarity in learning outcomes of CRE learners instructed by constructive simulation, and those instructed with a conventional approach. The research employed a quasi-experimental study with groups under treatment and control, incorporating a pre-test and post-test approach. In total, 90 form two CRE learners from two sub-county secondary schools were purposively selected for the research. Data were collected using the Learner Attainment test in CRE as the assessment tool. The research utilized correlation analysis to establish the similarity scores between the pre-test and post-test assessments. Additionally, the t-test statistical model was employed to test the effectiveness of the two teaching methods. Results revealed a strong positive connection between the two assessment tests of learners taught using constructive simulation (r = 00.0510, p < 0.01) and conventional method (r ═ 0.673, p < 0.01). Notably, constructive simulation (t (49) = - 9.76, n = 50, p < 0.05) significantly outperformed the conventional method of teaching (t (39) = 2.700, n = 40, p < 0.324). These findings implied that constructive simulation was more effective in enhancing learning outcomes as opposed to the conventional method of teaching. The results suggest that when designing curricula and formulating educational policies, educators and policymakers should incorporate constructive simulation as a learner-centred method.

Predictive factors for seizure freedom after epilepsy surgery for pediatric low-grade tumors and focal cortical dysplasia.

Epilepsy may be drug-resistant in a third of patients necessitating alternative treatments, such as surgery. Among refractory epilepsy patients, the most common etiologies are tumors and focal cortical dysplasia (FCD). Surgical management of tumor-related epilepsy has one of the highest rates of seizure freedom, whereas FCD represents some of the lowest success rates in epilepsy treatment. This study investigates the pre-operative characteristics associated with differences in postsurgical seizure outcomes in patients with FCD and tumors. We completed a retrospective cross-sectional review of epilepsy surgery patients with tumors (n = 29) or FCD (n = 44). Participants had a minimum medical follow-up at least 6 months after surgery (FCD M = 2.1 years; Tumors M = 2.0 years). Patients with FCD trended toward an earlier age of onset (t = -4.19, p = 0.058) and longer epilepsy duration (t = 3.75, p < 0.001). Epilepsy surgery is highly effective in reducing seizures in patients with FCD or tumors with over 70 % of all patients achieving seizure freedom. We found a higher rate of seizure freedom in patients with tumors than FCD, but this difference did not reach significance (79 vs. 66 %). Predictive factors of outcomes for FCD and tumors differ. Findings indicate that diagnostic tests may be differentially sensitive to patients with tumors, and future research is needed.