Outcome Definitions Research Articles

Comparison of augmented reality with other teaching methods in learning anatomy: A systematic review

AbstractAugmented reality (AR) has been investigated as an engaging educational tool that motivates undergraduate health science students to learn human anatomy. AR technology is developing rapidly, supporting medical education by presenting models of human anatomy as digital objects overlaid in the real world via mobile or head‐mounted display (HMD). The purpose of this systematic review is to provide a post‐pandemic analysis of AR compared with other methods for teaching anatomy and to determine the effects of AR on learning outcomes (LOs). Original research published between January 2020 and April 2024 was obtained from the WOS, Scopus, MEDLINE(Ovid), EMBASE, and PubMed databases, following PRISMA 2020 protocols. Articles included for analysis compared AR with alternative pedagogical methods of teaching undergraduate human anatomy. Studies that described AR as “mixed reality” (MR) were included, while those describing “virtual reality” (VR) were not considered. Risk of bias and limitations in individual studies were assessed using the Quality Assessment with Diverse Studies (QuADS) tool. Data were synthesized using a convergent integrated approach with LOs tabulated for visual analysis. A total of 17 articles were eligible for review: nine studies comparing AR via HMD hardware, and eight comparing mobile AR. The LOs of 12 studies were overwhelmingly reported as non‐significant. Insufficient data precluded an accurate meta‐analysis of LOs, and critical analysis revealed a considerable risk of bias and lack of justified methodology. While AR holds potential for supporting undergraduate students in learning anatomy, definitive outcomes from the current literature are limited by the heterogeneous nature of the studies and inconsistent use of terminology. It is recommended that future research employs professional AR technologies and incorporates the perspectives of university educators to ensure reliable outcomes that can direct the further development of AR technology in medical education.

Abstract 4136654: Urine Output Response to a Furosemide Infusion is Associated with Acute Kidney Injury in Infants Following Cardiac Surgery

Background: Acute kidney injury (AKI) following cardiac surgery in infants is common and associated with longer mechanical ventilation times and length of stay. Prior studies have shown that a lack of responsiveness to bolus dose furosemide has been associated with increased incidence of AKI. However, these studies have excluded patients on continuous furosemide infusions who are often younger, more hemodynamically unstable, and at higher risk for AKI. Hypothesis: Decreased urine output after initiation of a furosemide infusion predicts development of AKI. Methods: A retrospective cohort study of infants (<1 year of age) was conducted who underwent cardiac surgery requiring cardiopulmonary bypass from 2020-2023 and were on a furosemide infusion post-operatively. The primary outcome was post-operative AKI as defined using KDIGO (Kidney Disease: Improving Global Outcomes) guidelines. A furosemide response score (FRS) was calculated using the total urine output divided by the total dose of furosemide administered over a given time. Univariate and multivariate analyses were performed, and receiver operating characteristic curves used to determine the discriminatory ability of the FRS with regards to the primary outcome. Results: A total of 155 infants (median age at surgery 9 days) were included. Overall, 77% of infants met definition for the primary outcome of AKI; 32% stage 1, 30% stage 2, and 15% stage 3. Lower FRS at 4, 10, and 24 hours after infusion initiation were associated with AKI development (p<0.0001). Younger age, smaller weight at surgery, lack of pre-operative feedings, pre-operative inotropic use and higher surgical complexity were also associated with a higher risk of AKI. An FRS (mL/mg/kg) cutoff of <11.3 at 4 hours, <25.5 at 10 hours, and <55.3 at 24 hours had good discriminatory ability (area under the curve 0.7-0.75) in predicting AKI stage 2 or 3 (p<0.001). Controlling for the significant univariate variables listed above, the FRS cutoffs remained an independent risk factor for the development of AKI stage 2 or 3, (p<0.01) and were significantly associated with longer mechanical ventilation days and length of stay. Conclusion: Lack of responsiveness to a furosemide infusion (as measured by urine output corrected for dose of furosemide) is associated with the development of AKI in a high-risk cohort of infants. These novel findings may be helpful to predict those at risk and allow for further investigations for modifiable risk factors.

Risk-Prediction Model of Restenosis after Endovascular Treatment for Peripheral Arterial Disease: A Systematic Review and Meta-analysis.

Peripheral artery disease (PAD) patients after endovascular treatment (EVT) have a relatively high restenosis rate. However, this risk can be mitigated through precise risk assessment and individualized self-management intervention plans. Moreover, the number of predictive models for restenosis risk in PAD patients after EVT is gradually increasing, yet these results of study exhibit certain discrepancies, raising uncertainties regarding the quality and applicability in clinical practice and future research. The objective of this study was to systematically evaluate risk-predictive models for restenosis in patients with PAD after EVT. A systematic review and meta-analysis of predictive model construction and validation using observational studies was undertaken. The China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Database, SinoMed, PubMed, Web of Science, Embase, and the Cochrane Library were searched from inception to January 1, 2024. Two researchers independently conducted literature screening and data extraction, encompassing study design, data sources, outcome definition, sample size, predictive factors, model development, and performance. The Prediction Model Risk of Bias Assessment Tool (PROBAST) was used for risk of bias and applicability assessment of the models. A total of 4275 studies were retrieved, ultimately resulting in the inclusion of 7 articles comprising 7 predictive models for restenosis in PAD patients after EVT, with a restenosis incidence ranging from 21.8% to 39.7%. The total sample size of the included models ranged from 137 to 1578 cases, with logistic regression analysis being the most commonly used modeling method. All models were built using R software. Only 2 models underwent external validation, and the reported area under the curve ranged from 0.728 to 0.864. The summary area-under-the-curve statistic was 0.80 (95% confidence interval [CI], 0.74-0.86), with an approximate prediction interval of 0.80 (95% CI, 0.62-0.91) . The number of included predictive factors ranged from 3 to 10, with the most common factors being age, Trans-Atlantic Inter-Society Consensus Ⅱ classification, hypertension, diabetes, high-sensitivity C-reactive protein, and surgical approach. All studies exhibited high risk of bias, primarily attributed to inappropriate sources of data and poor reporting of the analysis domain. Predictive models for restenosis after EVT in PAD patients demonstrate overall good predictive performance but are still in the developmental stage with higher risk of bias. Future studies should follow the TRIPOD statement, focusing on the development of new models with larger samples, rigorous study designs, and multicenter external validation. This systematic review adheres to the PRISMA 2020 statement, offering the most recent systematic assessment of risk prediction models for restenosis following endovascular treatment in peripheral arterial disease.The newly developed PROBAST tool was employed to assess the risk of bias and the applicability of the existing evidence.This review emphasizes the practical utility, limitations of the current evidence, and recommendations for future research, with the goal of providing valuable information for clinicians and patients in their decision-making process, while also supporting the advancement of future research endeavors.

Harmonizing data across the accelerating colorectal cancer screening and follow-up through implementation science (ACCSIS) program to enhance data quality and promote data sharing

BackgroundThe purpose of the Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) Program, a Cancer Moonshot℠ Initiative, is to support research to build the evidence base on multilevel interventions that increase rates of colorectal cancer screening, follow-up, and referral to care to address disparities in colorectal cancer screening. The National Cancer Institute funded eight Research Projects to implement multilevel interventions to improve colorectal cancer screening among communities who traditionally have been medically underserved. To analyze the impact of ACCSIS across Research Projects, the consortium developed a set of common data elements. The purpose of this paper is to describe the process of developing the common data elements to facilitate analysis of ACCSIS data as well as support and inform implementation science research studies.MethodsThe ACCSIS Data, Design, and Analysis Work Group was tasked with designing common data elements through a review of existing data collection instruments, examination of data elements proposed by the ACCSIS Research Projects, and deliberations on the data required to compare across the Research Projects. ACCSIS Consortium members drafted, revised, and finalized a common data elements document consisting of variables to collect and surveys to administer to evaluate ACCSIS implementation activities and outcomes in a standardized manner across the Research Projects.ResultsThe ACCSIS Consortium decided to collect the following categories of common data elements: characteristics across multiple levels of the multicomponent interventions, implementation climate, and determinants; interventions and strategies; implementation outcome constructs and definitions; colorectal cancer screening episodes (screening, diagnostic testing follow-up, cancer detection, and cancer treatment); and cost measures. To assess implementation climate, the consortium prioritized constructs from five domains of the Consolidated Framework for Implementation Research.ConclusionsThe ACCSIS common data elements offer a set of harmonization data for future implementation efforts. The consortium is conducting a systematic assessment using both quantitative and qualitative approaches to assess data quality and approaches to improve and sustain data collection. Lessons learned from these ongoing activities will offer additional insights to tailor the ACCSIS common data elements and support efforts to increase colorectal cancer screening for populations experiencing disparities.

Association between tumour somatic mutations and venous thromboembolism in the 100,000 Genomes Project cancer cohort: a study protocol

Venous thromboembolism (VTE) is a common cause of morbidity and mortality in patients with cancer. There is evidence that specific aberrations in tumour biology contribute to the pathophysiology of this condition. We plan to examine the association between tumour somatic mutations and VTE in an existing cohort of patients with cancer, who were enrolled to the flagship Genomics England 100,000 Genomes Project. Here, we outline an a-priori analysis plan to address this objective, including details on study cohort selection, exposure and outcome definitions, annotation of genetic variants and planned statistical analyses. We will assess the effect of 1) deleterious somatic DNA variants in each gene; 2) tumour mutational burden and 3) tumour mutational signatures on the rate of VTE (outcome) in a pan-cancer cohort. Sensitivity analyses will be performed to examine the robustness of any associations, including adjustment for potentially correlated co-variates: tumour type, stage and systemic anti-cancer therapy. We hope that results from this study may help to identify key genes which are implicated in the development of cancer associated thrombosis, which may shed light on related mechanistic pathways and/or provide data which can be integrated into genetic risk prediction models for these patients.

Recent advances in chronic rhinosinusitis: pathophysiology, treatments, and outcome measures.

This review discusses major developments in chronic rhinosinusitis. The latest papers on prevalence of the disease, the burden for patients and society, the lack of awareness, the development of patient classifications and the consequences for the management of the disease. Our discussion includes major developments in the treatment of the disease with biologics but also their limitations. Recent developments also include evolution in the goals of care, where until recently we were content with control of disease but now start to aim for remission and maybe even cure. To reach that aim we need better definitions of disease, outcomes and biomarkers to predict the optimal moment of intervention in the development of the disease. Time will tell whether earlier intervention can prevent development of the disease and later sequelae.

Association between perioperative platelet distribution width changes and postoperative acute kidney injury in patients with renal insufficiency: a retrospective study

BackgroundAcute kidney injury (AKI) is a major complication following cardiac surgery with a high incidence in those with existing kidney dysfunction. Platelet distribution width (PDW) reflects variability in platelet size and serves as an indicator of platelet activation. Recent investigations linked PDW changes to kidney pathology, suggesting its utility in identifying individuals at risk for AKI, thus necessitating exploration of its predictive value.MethodsPatients with preoperative renal dysfunction [15 ≤ estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2] who underwent cardiac surgery from January 2018 to December 2021 were retrospectively enrolled. PDW values were measured preoperatively and again upon admission to the ICU immediately after cardiac surgery, with the change in PDW (dPDW) defined as the difference between these two measurements. The primary outcome was postoperative AKI, defined base on the Kidney Disease: Improving Global Outcomes (KDIGO) definition and staging criteria. Multivariate regression models were performed to identify the association between dPDW and AKI and its potential trend. Restricted cubic spline analysis assessed non-linear associations between dPDW and AKI. The Youden index identified an optimal dPDW cut-off for AKI prediction. Subgroup analysis was performed to elucidate the consistency of these associations across the various subgroups.ResultsAKI occurred in 53.10% (513/966) of patients, accompanied by significant PDW increases in cases of AKI (P < 0.001). After adjusting confounders, dPDW was identified as a significant risk factor for AKI [odds ratio (OR) = 1.09, 95% confidence interval (CI): (1.02 ~ 1.16), P = 0.012]. Patients in the highest dPDW quartile (Q4) had a 195% higher AKI risk compared to those in the lowest quartile (Q1) (OR = 2.95, 95% CI:1.78 ∼ 4.90, P < 0.001). Trend analysis indicates that the risk of AKI increased with higher dPDW quartiles (P for trend < 0.001). Youden index showed that dRDW = 1.1 was identified as the optimal diagnostic cut-off value for AKI. Subgroup analyses and interaction tests showed a robust association between dPDW and AKI in all subgroups (P for interaction > 0.05).ConclusionsThis study underscored perioperative PDW changes as a significant predictor of postoperative AKI in patients with renal insufficiency, highlighting its potential in refining risk stratification and management strategies.Clinical trial numberNot applicable for this observational retrospective study.

Does preprocedural ultrasound prior to lumbar neuraxial anesthesia or analgesia increase first-pass success in adults with obesity? A systematic review.

Preprocedural ultrasound (PPU) reduces the risk of technical failure in non-obese patients and when technical difficulty is predicted. We conducted this review to determine if PPU improves first-pass needle insertion success for neuraxial anesthesia in patients with obesity. We conducted a systematic review without meta-analysis, due to the small number of included studies. The study protocol was registered (PROSPERO: CRD42022368271). We conducted searches in MEDLINE, Embase, PubMed, and Cochrane Library from January 1, 1980 to October 1, 2022 for peer-reviewed randomized controlled or observational studies comparing PPU versus landmark techniques in patients with body mass index >30 kg/m2. The quality of evidence was assessed using the revised Cochrane risk-of-bias tool for randomized trials and Grading of Recommendations Assessment, Development, and Evaluation approach. There were nine randomized controlled studies, comprising 866 patients having lumbo-sacral neuraxial techniques. Three studies utilized a small handheld ultrasound device called Accuro™ and six utilized non-handheld ultrasound devices. Certainty of evidence was low for improving the first-pass success rate. There was evidence (moderate certainty) that PPU decreased number of passes, increased first insertion attempt success, and reduced number of insertion attempts. There was no evidence that PPU affected identifying time, needling time, or overall procedural time. There was no evidence that PPU influenced procedural failure rate (very low certainty evidence) and insufficient evidence to suggest that artificial intelligence-supported handheld devices were superior to conventional ultrasound devices. In patients with obesity, there is evidence of very-low to moderate certainty that PPU improves markers of insertion success, with no indication of increased adverse effects. PPU should be used to reduce attempts. Further studies adhering to standardized outcome definitions are required for definitive recommendations. The study protocol was registered on the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022368271).

High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in crohn disease: literature review

The literature review presents the current status of the method of high-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in the treatment of Crohn’s disease.In recent decades, there has been an increase in Crohn’s disease. The frequency of CD the response rate to biopreparations ranges from 20 to 50%, up to 80% of patients need surgical treatment. Due to the insufficient effectiveness of therapy, an active research is underway for new therapeutic opportunities, one of which is the method of HDIT-AHSCT. In the Russian Federation, there are data on the use of mesenchymal stem cells for the treatment of CD, there are no studies on the use of HDIT-AHSCT in IBD. According to the EBMT register in the period from 1994 to 2023. more than 4000 HDIT-AHSCT were performed in patients with autoimmune diseases, the proportion of CD was 6.13% of all protocols. The HDIT-AHSCT procedure consists of the following stages: mobilization of autologous HSCs, apheresis and cryopreservation of HSCs, immunoablative conditioning and infusion of HSCs. Most of the publications on the use of HDIT-AHSCT in CD were not universal in the selection and management of patients. Currently, there is the only one completed RCT on the use of HDIT-AHSCT in CD, the results of which have not received a definite outcome. However, for a cohort of patients with refractory CD, it is necessary to consider the possibility of using this method. The review presents the indications and selection criteria for the HDIT-AHSCT protocol. Further studies of the HDIT-AHSCT in CD will help expand the therapeutic opportunities of treating patients with refractory CD to standard and biological therapy.

Efficacy and safety of higher dose rifampicin in adults with presumed drug-susceptible tuberculosis: an updated systematic review and meta-analysis

Tuberculosis (TB) remains a significant cause of mortality globally, yet first-line treatment has hardly changed for fifty years. The dose of rifampicin, the most important drug in this regimen, has been historically based on pragmatic cost- and risk-benefit considerations. Evidence suggests the current recommended dose (8-12mg/kg) may not maximise the potential benefits of this drug. We sought to evaluate the efficacy and safety of higher doses of rifampicin in adults with presumed drug-susceptible TB. In this systematic review we searched MEDLINE, EMBASE, CENTRAL and Global Health databases for randomised controlled trials up to 31 July 2024 of adults with presumed drug-susceptible TB receiving first-line treatment with an intervention of rifampicin doses higher than currently recommended. Meta-analyses were performed using random effects models where background regimens were the same. Risk ratio was used as the measure for treatment effect. Outcomes of interest related to efficacy and safety. Of the 5441 total records identified by our searches, nineteen studies (6332 patients, 31.0% female) were eligible for the systematic review and twelve (3763 patients, 31.0% female) for meta-analysis. Rifampicin doses varied from 8 to 35mg/kg and implementation of the intervention varied between trials. There was no evidence for increased efficacy with higher doses of rifampicin, however the majority of trials investigated minimally increased doses (up to 20mg/kg). At higher doses (>20mg/kg), there may be evidence of increased risk of drug-induced liver injury, albeit with no consistent dose-response relationship. Evidence on the efficacy of higher doses of rifampicin in the first-line regimen for TB remains incomplete. While higher doses appear generally safe, the risk of drug-induced liver injury may be increased above doses of 20mg/kg. Larger clinical trials reporting definitive outcomes are needed to determine whether dosing up to 40mg/kg could safely improve treatment outcomes or reduce duration of first-line therapy. WHO, Wellcome Trust.

Investigation the Role of Calcium and Vitamin D3 And Some Biochemical Parameters in Patients with Renal Failure of Renal Failure

Coronavirus Disease 2019 is a primarily respiratory illness that can cause thrombotic disorders. Elevation of D-dimer is a potential biomarker for poor prognosis in COVID-19, though optimal cutoff value for D-dimer to predict mortality has not yet been established. This study aims to assess the accuracy of admission D-dimer in the prognosis of COVID-19 and to establish the optimal cutoff D-dimer value to predict hospital mortality. Clinical and laboratory parameters and outcomes of confirmed COVID-19 cases admitted to four hospitals in Kathmandu were retrospectively analyzed. Admitted COVID-19 cases with recorded D-dimer and definitive outcomes were included consecutively. D-dimer was measured using immunofluorescence assay and reported in Fibrinogen Equivalent Unit (μg/ml). The receiver operating characteristic curve was used to determine the accuracy of D-dimer in predicting mortality, and to calculate the optimal cutoff value, based on which patients were divided into two groups and predictive value of D-dimer for mortality was measured. D-dimer levels were higher in COVID-19 patients and were related with markers of inflammation, and after treatments, D-dimer levels decreased which was synchronous with hsCRP levels in patients with good clinical prognosis. Also, the low correlation between Padua VTE score and D-dimer levels weakened the role of D-dimer in the prediction of thrombosis.The abnormal changes of D-dimer and inflammatory factors suggest that aggressive anticoagulant therapy might be needed.

Chronic subdural hematoma: Management, sequelae with its predictive factors, and health-related quality of life of survivors

Objectives: The objective of the study is to identify the risk factors associated with chronic subdural hematoma (CSDH) in the Pakistani population, to compare various surgical techniques commonly used in its management, and to analyze the outcomes of patients, including early, that is, at the time of discharge, and late, that is, the disability status of patients on follow-up after ≥6 weeks. Materials and Methods: This retrospective study was carried out at a tertiary care hospital in Pakistan between March 2023 and October 2023 and included 100 patients with CSDH. All patients underwent surgical procedures, and outcomes were assessed at six weeks. Results: The mean age of the patients diagnosed with CSDH in this study was 53.81 ± 11.54 years. The most commonly reported symptom was an altered level of consciousness (30%), but most patients presented with more than one symptom (50%). Mortality was associated with only 10% of cases, and 90% reported no complications or significant morbidity. The most commonly used surgical technique was two burr-hole drainage (67%). The risk of recurrence was increased with the presence of comorbidities (P = 0.001) and remarkably reduced with intraoperative subdural drain placement (P = 0.000). Conclusion: The choice of surgical technique had no influence on the length of stay in the hospital or functional status post-discharge but surgery with intraoperative subdural drain placement proved to yield definitive favorable outcomes.

Spontaneous space closure after extraction of young first permanent molar. Retrospective cohort study.

Early compromised first-permanent-molar (FPM) extraction can adversely affect occlusion. However, the current literature does not provide sufficient support for definitive early extraction outcome. This cohort study aimed to evaluate the pattern of post-FPM extraction spontaneous space closure and its pre-extraction indicators. Patients of 7-13 years, with compromised FPM at three-tertiary-centers between 2015 and 2019 were retrospectively screened. Pre-extraction indicators were evaluated (extraction location, direction of the second permanent molar (SPM) long-axis, and SPM Demirjian development stage). Spontaneous space closure pattern was evaluated clinically and radiographically using the American Board of Orthodontics (ABO) grading system. In total, 112 FPMs (73-patients) were identified and five (4.5%) of the extraction sites showed favorable combined-ABO-scores. Distal direction of the SPM long-axis in the maxillary arch significantly decreased the relative risk (RR) of having a SPM rotation/alignment ABO score-1 (P = 0.002; RR = 0.64). For the mandibular arch, Demirjian stage D and E significantly decreased the RR of having ABO score-1 for spacing between the SPMs and second premolars (P = 0.029; RR:0.57, P = 0.004; RR:0.53, respectively) and vertical dimension (P = 0.02; RR = 0.53). The direction of the SPM long-axis and its developmental stage are key indicators of the favorable outcome pattern of spontaneous space closure after FPM early extraction.

Transforming respiratory diseases management: a CMO-based hospital pharmaceutical care model.

Respiratory diseases encompass a diverse range of conditions that significantly impact global morbidity and mortality. While common diseases like asthma and COPD exhibit moderate symptoms, less prevalent conditions such as pulmonary hypertension and cystic fibrosis profoundly affect quality of life and mortality. The prevalence of these diseases has surged by approximately 40% over the past 3decades. Despite advancements in pharmacotherapy, challenges in drug administration, adherence, and adverse effects persist. This study aimed to develop and perform an interim validation of a Capacity-Motivation-Opportunity (CMO) model tailored for respiratory outpatients to enhance pharmaceutical care, which is the direct, responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient's quality of life, and overall wellbeing. This cross-sectional, multicenter study was conducted from March 2022 to March 2023. It comprised four phases: 1) forming an expert panel of 15 hospital pharmacists, 2) selecting respiratory pathologies based on prevalence and severity, 3) developing the CMO model's pillars, and 4) integrating and conducting an interim validation of the model. The Capacity pillar focused on patient stratification and personalized care; the Motivation pillar aligned therapeutic goals through motivational interviewing; and the Opportunity pillar promoted the use of information and communication technologies (ICTs) for telemedicine. The model included eight respiratory diseases based on expert assessment. For the Capacity pillar, 22 variables were defined for patient stratification, leading to three priority levels for personalized pharmaceutical care. In a preliminary test involving 201 patients across six hospitals, the stratification tool effectively classified patients according to their needs. The Motivation pillar adapted motivational interviewing techniques to support patient adherence and behavior change. The Opportunity pillar established teleconsultation protocols and ICT tools to enhance patient monitoring and care coordination. The CMO model, tailored for respiratory patients, provides a comprehensive framework for improving pharmaceutical care. By focusing on patient-centered care, aligning therapeutic goals, and leveraging technology, this model addresses the multifaceted needs of individuals with respiratory conditions. Future studies are necessary to validate this model in other healthcare systems and ensure its broad applicability.

IPNA consensus definitions for clinical trial outcomes in steroid-resistant nephrotic syndrome.

Assessment of the true impact of therapeutic interventions is a challenge in the absence of universal, standardized definitions for clinical trial endpoints in children with kidney diseases. Steroid-resistant nephrotic syndrome (SRNS) is a difficult kidney disease to treat, with unremitting disease progressing to kidney failure. Currently, available therapies result in suboptimal cure rates. Clinical trials with innovative, targeted treatments will likely be conducted for this disease in the foreseeable future. An international consortium of the IPNA Best Practices and Standards Committee and the Pediatric Nephrology Expert Group of the conect4children (c4c) network developed through consensus, standardized, internationally acceptable definitions for trial outcomes for SRNS. The endpoint definitions were formulated for use with urine protein to creatinine ratios and estimated glomerular filtration rates. Definitions of complete remission, partial remission, non-remission of disease, reduction in proteinuria, kidney disease progression, kidney failure, and composite kidney outcome were refined using an iterative process until a consensus was achieved.

Systematic review on oral antibacterial relay therapy for acute staphylococcal prosthetic joint infections treated with debridement, antibiotics and implant retention (DAIR).

The management of acute prosthetic joint infections (PJIs) often involves a debridement, antibiotics and implant retention (DAIR) strategy. Our objective was to conduct a systematic review and a network meta-analysis (NMA) to assess the comparative effectiveness of available oral antimicrobial regimens for the treatment of acute staphylococcal PJIs treated with DAIR. We conducted a systematic review searching articles from databases creation until 31 December 2023. We included articles on acute staphylococcal PJIs managed with DAIR with an oral antibiotic regimen relaying the initial management. The primary outcome was the remission rate. Out of the 2421 studies screened, six studies completed the systematic review criteria: one randomized controlled trial and five observational studies. There was heterogeneity in patients' populations, duration and posology of treatments, definition of outcome and length of follow-up. Studies revealed 10 antibiotic regimens and most data focusing on five combinations recommended by the IDSA's guidelines: rifampicin associated to fluoroquinolone, clindamycin, cycline, linezolid or trimethoprim-sulfamethoxazole. Treatment comparisons were often secondary, without adjustment for confounding factors, resulting in a high risk of bias. Owing to inconsistencies a complete analysis, including an NMA was not possible. The available data highlight five companions to rifampicin, however, there is insufficient evidence to compare them. The literature does not provide a basis for rationalizing alternatives when rifampicin cannot be used.

Association of computed tomography-derived body composition and complications after colorectal cancer surgery: A systematic review and meta-analysis.

The prediction of the risk of developing complications after colorectal surgery for colorectal carcinoma remains imprecise. Body composition measurements on a computed tomography (CT) scan can potentially contribute to a better preoperative risk assessment. The aim of this systematic review is to evaluate the evidence for the use of body composition measurements on CT scans to predict short-term complications after colorectal cancer surgery. A literature search (in PubMed, Embase and Web of Science) was performed up to 1 August 2022. Two researchers independently screened the articles, extracted data and assessed the quality of the studies using the Quality in Prognosis Studies tool. The primary outcome measure was the occurrence of complications within 30days after surgery. Meta-analysis was conducted using a random-effects model to synthesize a pooled odds ratio (OR). The study protocol was registered in PROSPERO (CRD42021281010). Forty-five articles with a total of 16537 patients were included. In total, 26 body composition measures were investigated: 8 muscle-related measures, 11 adipose tissue measures, 4 combined muscle and adipose tissue measures, and 3 other measures. These were investigated as potential predictors for more than 50 differently defined postoperative complications. Meta-analysis was only possible for two measurements and showed that higher amounts of visceral fat increase the risk of developing overall complications (OR: 2.52 [1.58-4.00], P<0.0001) and anastomotic leakage (OR: 1.76 [1.17-2.65], P=0.006). A wide variety of body composition measurements on preoperative CT scans have been investigated as a predictive factor for postoperative complications. Visceral fat appeared to be associated with overall complications and anastomotic leakage; however, the association is weak, and its clinical relevance or applicability is questionable. The current evidence is limited by methodological heterogeneity and the risk of bias. To improve comparability of results across studies and improve decision-making, future studies should use standardized methods for measuring body composition on CT scans, outcome definitions and statistical analyses.

Network Meta-Analysis: Histologic and Histo-Endoscopic Improvement and Remission With Advanced Therapy in Ulcerative Colitis.

Histology has prognostic value in ulcerative colitis (UC). However, direct comparisons of histological endpoints are lacking. To perform a network meta-analysis (NMA) to compare histological endpoints with biologics and small molecules. We searched four databases up until July 2024 for randomised controlled trials (RCTs) on advanced therapies for moderate-to-severe UC reporting histological endpoints. Outcomes included histological improvement or remission, and histo-endoscopic improvement after induction or during maintenance. We used a random-effects frequentist model and have reported outcomes as relative risk and 95% confidence interval. We estimated relative drug efficacy with the P-score. We conducted subgroup analysis by trial phase and evaluated risk of bias and evidence certainty. We included 24 RCTs (15 therapies, 8874 patients). Nineteen provided data on induction and 10 on maintenance; outcome definitions were similar. Etrasimod 2 mg/day ranked highest in achieving histologic improvement (P-score 0.98) and remission (P-score 0.90) following induction. Globally, guselkumab 200-400 mg ranked first for histo-endoscopic improvement, while etrasimod 2 mg/day and upadacitinib 45 mg/day were superior in the subgroup analysis. During maintenance, upadacitinib 30 mg/day was superior in achieving histologic improvement and remission (P-score 0.88 for both) and histo-endoscopic improvement (P-score 0.94). Etrasimod 2 mg/day ranked second for histologic remission (P-score 0.70) and histo-endoscopic improvement (P-score 0.73), while mirikizumab 200 mg/month ranked second for histologic improvement. These results support the ability of small molecules to achieve stringent endpoints in moderate-to-severe UC. Histological outcome data for biologics was sparser, particularly during maintenance. Head-to-head RCTs are imperative to better inform clinical practice.

Long-term efficacy (at and beyond 1 year) of gastric peroral endoscopic myotomy for refractory gastroparesis: A systematic review and meta-analysis.

Although gastric peroral endoscopic myotomy (G-POEM) has shown substantial efficacy in patients with medically refractory gastroparesis (GP), comprehensive long-term data on its effectiveness are lacking. We conducted a systematic review and meta-analysis including observational studies assessing long-term efficacy after G-POEM in patients with refractory GP. Our primary outcome was the pooled rate of clinical success 1-year after G-POEM. Secondary outcomes included clinical success at 2 and 3 years and the rate of adverse events according to the American Society for Gastrointestinal Endoscopy classification. Thirteen studies, involving 952 patients with refractory GP undergoing G-POEM, were eligible. The pooled 1 year-clinical success was 0.72 (95% confidence interval [CI]: 0.56, 0.85, I2 = 94.9%). The clinical success was 0.67 (95% CI: 0.47, 0.97, I2 = 95.8%) when considering only studies defining success as 1 point decrease in Gastroparesis Cardinal Symptoms Index score and at least 25% decrease in two subscales. For patients who had 1-year success, the pooled clinical success at 2 and 3 years were 0.71 (95% CI: 0.45, 0.92, I2 = 94.9%) and 0.58 (95% CI: 0.19, 0.92, I2 = 97.1%), respectively. The pooled rate of adverse events was 0.08 (95% CI: 0.06, 0.10, I2 = 0%). G-POEM is associated with successful outcomes in about 70% of treated cases after 1 year, with durable long-term effects lasting up to 3 years. In the future, new uniform outcome definitions and strict patient selection criteria are warranted to delineate G-POEM outcomes more accurately.

Placebo rates in Crohn’s disease randomized clinical trials: An individual patient data meta-analysis

Understanding placebo rates is critical for efficient clinical trial design. We assessed placebo rates and associated factors using individual patient data (IPD) from Crohn's disease (CD) trials. We conducted a meta-analysis of phase 2/3 placebo-controlled trials evaluating advanced therapies in moderate-to-severe CD (2010-2021). Deidentified IPD were obtained through Vivli Inc. and Yale University Open Data Access Project. Primary outcomes were clinical response and remission. Pooled placebo rates and 95% confidence intervals (CIs) were estimated using one- and two-stage meta-analytical approaches. Regression analyses identified patient-level factors associated with placebo rates. Using IPD from eight induction (n=1147) and four maintenance (n=524) trials, overall placebo clinical response and remission rates for induction were 27% (95%CI=23-32%) and 10% (95%CI=8-14%) respectively, and 32% (95%CI=23-42%) and 22% (95%CI=14-33%) for maintenance, respectively. Among bio-naïve patients, placebo response and remission rates during induction were 29% (95%CI=24-35%) and 11% (95%CI=8-15%) respectively, and 26% (95% CI=20-33%) and 10% (95% CI=8-14%) for bio-exposed, respectively. During maintenance, bio-naïve response and remission rates were 41% (95%CI=34-48%) and 32% (95%CI=24-40%), respectively, and 29% (95%CI=24-34%) and 16% (95%CI=13-21%) for bio-exposed, respectively. Higher baseline C-reactive protein concentration predicted lower placebo rates, while higher baseline albumin levels and body mass index increased the odds of placebo outcomes. Increased baseline Crohn's Disease Activity Index and 2-item patient-reported outcome scores predicted higher response rates in induction, lower response rates in maintenance, and lower remission rates in induction and maintenance. Patient- and trial-level characteristics influence placebo rates in CD trials. Careful implementation of eligibility criteria, outcome definitions, and patient stratification may reduce placebo rates.