AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals. OBJECTIVE: The systematic review outlined in this protocol aims to yield insights into the frequency and severity of AEs while characterizing the events using existing regulatory guidance. METHODS: Publicly accessible AE databases will be searched to identify AE reports for AIaMD. Scoping searches have identified 3 regulatory territories for which public access to AE reports is provided: the United States, the United Kingdom, and Australia. AEs will be included for analysis if an artificial intelligence (AI) medical device is involved. Software as a medical device without AI is not within the scope of this review. Data extraction will be conducted using a data extraction tool designed for this review and will be done independently by AUK and a second reviewer. Descriptive analysis will be conducted to identify the types of AEs being reported, and their frequency, for different types of AIaMD. AEs will be analyzed and characterized according to existing regulatory guidance. RESULTS: Scoping searches are being conducted with screening to begin in April 2024. Data extraction and synthesis will commence in May 2024, with planned completion by August 2024. The review will highlight the types of AEs being reported for different types of AI medical devices and where the gaps are. It is anticipated that there will be particularly low rates of reporting for indirect harms associated with AIaMD. CONCLUSIONS: To our knowledge, this will be the first systematic review of 3 different regulatory sources reporting AEs associated with AIaMD. The review will focus on real-world evidence, which brings certain limitations, compounded by the opacity of regulatory databases generally. The review will outline the characteristics and frequency of AEs reported for AIaMD and help regulators and policy makers to continue developing robust safety monitoring processes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48156.

Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review.

BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report. OBJECTIVE: This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes. METHODS: This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate. RESULTS: The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024. CONCLUSIONS: Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance. TRIAL REGISTRATION: PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51614.

Clinical profile of adult and pediatric patients with hepatic Wilson's disease.

BACKGROUND: The clinical profile varies in patients with Wilson's disease (WD). There is paucity of data regarding adult and pediatric patients with hepatic WD. METHODS: As many as 140 consecutive patients diagnosed with hepatic WD between December 2006 and January 2021 were included in the study. Data was collected regarding the demographic parameters, clinical presentation, extrahepatic organ involvement, liver histology and laboratory investigations. Adult and children (0-14 years) with hepatic WD were compared regarding these features. RESULT: Eighty-eight adults and 52 children were included in the study. The median age of presentation was 17 years (range: 1.1-42 years). Male preponderance was seen (adult 68/88, 69%; children 40/52, 77%). Adults as compared to children presented more commonly as cirrhosis (52/88 vs. 15/52, p = 0.0005) and with hepatic decompensation (35/88 vs. 9/52, p = 0.005). Presentation with acute-on-chronic liver failure (ACLF) was more common in children (10/52 vs. 2/88, p = 0.0005). Twenty-eight-day mortality was 50% (5/10) in children and none in adults presenting with ACLF. Nazer's Prognostic Index (≥ 7) and New Wilson Index were more accurate in predicting mortality among children with ACLF with AUROC 1, while AARC (APASL ACLF Research Consortium) was less accurate with AUROC 0.45. Liver histology findings were similar in adults and children. Extrahepatic involvement was also similar. (8/88 in adults vs. 3/52 children, p value 0.48). CONCLUSION: Most patients with WD present as cirrhosis in adulthood. ACLF is more common in children. Nazer's prognostic index and new Wilson Index score are accurate in predicting mortality in children with ACLF.

Adverse events with endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction-A systematic review and meta-analysis.

BACKGROUND: The technical and clinical effectiveness of endoscopic ultrasonography (EUS)-guided gastroenterostomy (GE) has been reported by several meta-analyses, but few of them have addressed the adverse events (AE). The goal of the current meta-analysis was to analyze the AEs associated with various types of EUS-GE. METHODS: All relevant studies reporting the AEs with EUS-GE were searched from 2000 to 31st March 2023 in MEDLINE, Embase, and Scopus. The event rates were pooled using a random effects model. RESULTS: A total of 36 studies (n = 1846) were included in the meta-analysis. The present meta-analysis reports a pooled technical success rate of 96.9% (95.9-98.0; I2 = 29.3%) with a pooled clinical success rate of 90.6% (88.5-92.7; I2 = 60.9%). The pooled incidence of overall AEs with EUS-GE was 13.0% (10.3-15.7; I2 = 69.7%), with the commonest being maldeployment of the stent, seen in 4.6% (3.2-6.0; I2 = 50.6%). The pooled incidences of serious AE and procedure-related mortality were 1.2% (0.7-1.8; I2 = 1.9%) and 0.3% (0.0-0.7; I2 = 0.0%), respectively. Subgroup analysis of studies using only the free-hand technique showed a significantly lower overall AE and maldeployment but not serious AE and other individual AEs. The pooled incidences of delayed stent migration and stent occlusion were 0.5% (0.0-1.1; I2 = 0.0%) and 0.8% (0.2-1.3; I2 = 0.0%), respectively. CONCLUSION: Despite a technical and clinical success rate of >90%, AEs are seen in around one-seventh of the cases of EUS-GE, maldeployment being the commonest. However, the pooled incidence of serious AE and mortality remains low, which is reassuring.

Outcome of individuals with alcoholic cirrhosis hospitalized with first decompensation and their predictors.

BACKGROUND OBJECTIVES: Alcohol is one of most common aetiologies of cirrhosis and decompensated cirrhosis is linked to higher morbidity and death rates. This study looked at the outcomes and mortality associated risk variables of individuals with alcoholic cirrhosis who had hospitalization with their first episode of decompensation. METHODS: Individuals with alcoholic cirrhosis who were hospitalized with the first episode of decompensation [acute decompensation (AD) or acute-on-chronic liver failure (ACLF)] were included in the study and were prospectively followed up until death or 90 days, whichever was earlier. RESULTS: Of the 227 study participants analyzed, 167 (73.56%) and 60 (26.43%) participants presented as AD and ACLF, respectively. In the ACLF group, the mortality rate at 90 days was higher than in the AD group (48.3 vs 32.3%, P=0.02). In the AD group, participants who initially presented with ascites as opposed to variceal haemorrhage had a greater mortality rate at 90 days (36.4 vs 17.1%, P=0.041). The chronic liver failure-consortium AD score and the lactate-free Asian Pacific Association for the study of the Liver-ACLF research consortium score best-predicted mortality in individuals with AD and ACLF. INTERPRETATION CONCLUSIONS: There is significant heterogeneity in the type of decompensation in individuals with alcoholic cirrhosis. We observed significantly high mortality rate among alcoholic participants hospitalized with initial decompensation; deaths occurring in more than one-third of study participants within 90 days.

AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices.

BACKGROUND: Artificial intelligence as a medical device (AIaMD) has the potential to transform many aspects of ophthalmic care, such as improving accuracy and speed of diagnosis, addressing capacity issues in high-volume areas such as screening, and detecting novel biomarkers of systemic disease in the eye (oculomics). In order to ensure that such tools are safe for the target population and achieve their intended purpose, it is important that these AIaMD have adequate clinical evaluation to support any regulatory decision. Currently, the evidential requirements for regulatory approval are less clear for AIaMD compared to more established interventions such as drugs or medical devices. There is therefore value in understanding the level of evidence that underpins AIaMD currently on the market, as a step toward identifying what the best practices might be in this area. In this systematic scoping review, we will focus on AIaMD that contributes to clinical decision-making (relating to screening, diagnosis, prognosis, and treatment) in the context of ophthalmic imaging. OBJECTIVE: This study aims to identify regulator-approved AIaMD for ophthalmic imaging in Europe, Australia, and the United States; report the characteristics of these devices and their regulatory approvals; and report the available evidence underpinning these AIaMD. METHODS: The Food and Drug Administration (United States), the Australian Register of Therapeutic Goods (Australia), the Medicines and Healthcare products Regulatory Agency (United Kingdom), and the European Database on Medical Devices (European Union) regulatory databases will be searched for ophthalmic imaging AIaMD through a snowballing approach. PubMed and clinical trial registries will be systematically searched, and manufacturers will be directly contacted for studies investigating the effectiveness of eligible AIaMD. Preliminary regulatory database searches, evidence searches, screening, data extraction, and methodological quality assessment will be undertaken by 2 independent review authors and arbitrated by a third at each stage of the process. RESULTS: Preliminary searches were conducted in February 2023. Data extraction, data synthesis, and assessment of methodological quality commenced in October 2023. The review is on track to be completed and submitted for peer review by April 2024. CONCLUSIONS: This systematic review will provide greater clarity on ophthalmic imaging AIaMD that have achieved regulatory approval as well as the evidence that underpins them. This should help adopters understand the range of tools available and whether they can be safely incorporated into their clinical workflow, and it should also support developers in navigating regulatory approval more efficiently. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52602.

Tata Memorial Centre Evidence Based Management of Colorectal cancer.

ABSTRACT: This review article examines the evidence-based management of colorectal cancers, focusing on topics characterized by ongoing debates and evolving evidence. To contribute to the scientific discourse, we intentionally exclude subjects with established guidelines, concentrating instead on areas where the current understanding is dynamic. Our analysis encompasses a thorough exploration of critical themes, including the evidence surrounding complete mesocolic excision and D3 lymphadenectomy in colon cancers. Additionally, we delve into the evolving landscape of perioperative chemotherapy in both colon and rectal cancers, considering its nuanced role in the context of contemporary treatment strategies. Advancements in surgical techniques are a pivotal aspect of our discussion, with an emphasis on the utilization of minimally invasive approaches such as laparoscopy and robotic surgery in both colon and rectal cancers, including advanced rectal cases. Moving beyond conventional radical procedures, we scrutinize the feasibility and implications of endoscopic resections for small tumors, explore the paradigm of organ preservation in locally advanced rectal cancers, and assess the utility of total neoadjuvant therapy in the current treatment landscape. Our final segment reviews pivotal trials that have significantly influenced the management of colorectal liver and peritoneal metastasis.

Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines.

The Consolidated Standards of Reporting Trials extension for Artificial Intelligence interventions (CONSORT-AI) was published in September 2020. Since its publication, several randomised controlled trials (RCTs) of AI interventions have been published but their completeness and transparency of reporting is unknown. This systematic review assesses the completeness of reporting of AI RCTs following publication of CONSORT-AI and provides a comprehensive summary of RCTs published in recent years. 65 RCTs were identified, mostly conducted in China (37%) and USA (18%). Median concordance with CONSORT-AI reporting was 90% (IQR 77-94%), although only 10 RCTs explicitly reported its use. Several items were consistently under-reported, including algorithm version, accessibility of the AI intervention or code, and references to a study protocol. Only 3 of 52 included journals explicitly endorsed or mandated CONSORT-AI. Despite a generally high concordance amongst recent AI RCTs, some AI-specific considerations remain systematically poorly reported. Further encouragement of CONSORT-AI adoption by journals and funders may enable more complete adoption of the full CONSORT-AI guidelines.

Risk of tuberculosis with anti-TNF therapy in Indian patients with inflammatory bowel disease despite negative screening.

BACKGROUND AND STUDY AIMS: Tuberculosis (TB) is a well-recognized adverse effect associated with using biological therapy to manage various autoimmune conditions. There is a dearth of information about the development of TB after using anti-TNF agents in patients with inflammatory bowel disease (IBD) from TB-endemic countries like India. This study aimed to estimate the risk of TB and its predictors after treatment with anti-TNF agents in patients with IBD. PATIENTS AND METHODS: The present study is a retrospective analysis of data of patients with IBD from two tertiary care centers in India receiving anti-TNF therapy. Patients who had undergone chest X-ray, high-resolution computed tomography of the chest, and tuberculin skin test, with a follow-up duration of at least 6 months, were included in the analysis. RESULTS: In this multi-center study, 95 patients on anti-TNF agents for IBD (Median age of onset: 27 years, 62.1 % males) were followed up for a median duration of 9 (6-142) months. Among patients with IBD, 79 (83.2 %) had Crohn's disease, and 16 (16.8 %) had ulcerative colitis. Infliximab was the commonest biological, used in 82.1 % of cases, followed by adalimumab (17.9 %). On follow-up, 8.4 % (8/95) of the patients developed TB, among which the majority had extrapulmonary tuberculosis (5/8). On multivariate analysis, the duration of biological (Odds ratio: 1.047, 95 % confidence interval 1.020-1.075; p = 0.001) use was the only independent predictor of the development of TB with biologicals. CONCLUSION: Among Indian patients with IBD, there is a high risk of TB with anti-TNF agents, which increases with the duration of therapy. The current methods for latent TB screening in Indians are ineffective, and predicting TB after initiating biological therapy is difficult.

Safety and efficacy of endoscopic retrograde cholangiopancreatography in pediatric pancreatic and biliary disorders.

INTRODUCTION: There is sparse data from India on indications, technical success, safety and outcomes of endoscopic retrograde cholangiopancreatography (ERCP) using standard adult duodenoscope in the pediatric population. METHODS: Retrospective analysis of prospectively maintained electronic endoscopy and clinical database was performed to identify pediatric patients (age ≤ 18 years) who underwent ERCP between January 2017 and December 2022. Demographics and procedural details including indications, cholangio-pancreatogram findings, endotherapy type performed, technical and clinical success and complications were noted. RESULTS: As many as 150 pediatric patients were included of whom 88 had pancreatic (mean age-13.7 years) and 62 had biliary disease (mean age- 14.9 years). Common pancreatic ERCP indications were chronic pancreatitis (n = 45 [51.1%]), pancreatic duct disruption fistula (n = 21 [23.9%]) and recurrent acute pancreatitis (n = 16 [18.2%]). Among biliary indications were choledocholithiasis (n = 29 [46.8%]), benign bile duct strictures (n = 13 [21%]), bile duct injury/leak and biliary stent removal (n = 7 [11.3%]) , choledochal cyst (n = 5  [8.1%]) and pancreatic mass causing biliary compression (n = 1 [1.6%]). Technical success in pancreatic and biliary ERCP was 94.3% and 95.2%, respectively, and clinical success was 84.1% and 93.5%, respectively. Most common complications following pancreatic ERCPs were acute pancreatitis (n = 9 [10.2%]) (mild = 5, moderate = 4) patients and post sphincterotomy bleed in one (1.1%). Among biliary ERCPs, post ERCP pancreatitis was seen in (n = 3 [4.8%]) (mild = 2, moderate = 1). CONCLUSION: ERCP can be safely and effectively performed in children using standard duodenoscope. Chronic pancreatitis, choledocholithiasis and pancreatic divisum are common pediatric ERCP indications.

Current paradigm of endoscopic ultrasound in biliary and pancreatic duct drainage: an update.

Endoscopic retrograde cholangiopancreatography (ERCP) is the workhorse for biliary and pancreatic ductal interventions. Despite advances in both endoscopes and accessories for ERCP, it still has limitations in the presence of altered anatomy, luminal obstruction hindering access to the papilla, and proximal duct obstructions by tight stricture, calculi or intraductal growth. Endoscopic ultrasound-guided biliary drainage (EUS-BD) and EUS-guided pancreatic duct drainage (EUS-PDD) have expanded the rescue procedures after failed ERCP. This review discusses the techniques and results of various EUS-BD procedures, as well as EUS-PDD.

Upfront tofacitinib in patients with biological-naïve ulcerative colitis - An Indian multicentric experience.

OBJECTIVES: Tofacitinib is a Janus Kinase inhibitor used for treating moderate to severe ulcerative colitis (UC), mainly after the failure of biological therapy. There is a paucity of data on the outcome of tofacitinib in biological-naïve UC patients. The present study was aimed at analyzing the safety and efficacy of tofacitinib in biological-naïve Indian patients with UC. METHODS: The present study retrospectively evaluated consecutive patients with biological-naïve moderate-to-severe active UC from six tertiary care centers in India receiving tofacitinib from September 2020 to September 2022. Clinical remission or response assessment was based on partial Mayo score (PMS) calculated at baseline and weeks eight, 16 and 24. RESULTS: Total 47 cases (57.4% male, median age: 32 years) were included. After eight weeks of therapy, 33 (70.2%) achieved clinical remission and eight (17.0%) had a primary failure. The baseline serum albumin at treatment initiation was the only independent predictor of remission at eight weeks (Odds ratio: 11.560, 95% CI: 1.478 - 90.404), but not at 16 weeks. By 24 weeks, 59.6% (28/47) of the patients were in remission and 29.8% (14/47) had stopped tofacitinib either due to failure (27.6%) or adverse events (AEs) (2.1%). Among the 47 patients, 10 (21.2%) cases developed AEs during follow-up, including two tuberculosis (4.2%), one cytomegalovirus (CMV) colitis (2.1%) and one herpes zoster (2.1%). Four patients with infection required temporary drug discontinuations. One required permanent discontinuation (mania). CONCLUSION: Upfront tofacitinib is effective in biologic-naïve Indian patients with moderate-severe UC. Further randomized studies are required to validate the study findings.

New Horizons in artificial intelligence in the healthcare of older people.

Artificial intelligence (AI) in healthcare describes algorithm-based computational techniques which manage and analyse large datasets to make inferences and predictions. There are many potential applications of AI in the care of older people, from clinical decision support systems that can support identification of delirium from clinical records to wearable devices that can predict the risk of a fall. We held four meetings of older people, clinicians and AI researchers. Three priority areas were identified for AI application in the care of older people. These included: monitoring and early diagnosis of disease, stratified care and care coordination between healthcare providers. However, the meetings also highlighted concerns that AI may exacerbate health inequity for older people through bias within AI models, lack of external validation amongst older people, infringements on privacy and autonomy, insufficient transparency of AI models and lack of safeguarding for errors. Creating effective interventions for older people requires a person-centred approach to account for the needs of older people, as well as sufficient clinical and technological governance to meet standards of generalisability, transparency and effectiveness. Education of clinicians and patients is also needed to ensure appropriate use of AI technologies, with investment in technological infrastructure required to ensure equity of access.

Predictors of proximal migration of straight biliary plastic stents.

BACKGROUND/AIMS: Proximal biliary plastic stent migration (PSM) remains a challenging complication. The study aims at determining the PSM rate, retrieval outcomes and factors associated with PSM. METHODS: Endoscopy database was analyzed from January 2016 to January 2021 to identify 1137 patients, who underwent stent removal or repeat endoscopic retrograde cholangiopancreatography (ERCP). Demography, methods of stent retrieval, outcomes and complications were noted. Logistic regression was performed to determine risk factors for PSM. Propensity score matching was done in a 1:1 manner using age, sex, comorbidities and indication to assess endoscopy-related factors. Clinical trial registration done (CTRI/2022/02/040516). RESULTS: PSM was noted in 74 (6.5%) cases. Stent retrieval was successful in 94.59% (70/74) of cases. A balloon catheter (46/74) was commonly used. Technical failure was due to an impacted stent (2) and stent above the stricture (2). Complications were seen in 2.7% of cases. On multi-variate regression, sphincteroplasty at index ERCP (Odds ratio [OR] = 5.68, 95% confidence interval [CI] = 2.7-11.89), stent length < 10 cm (OR = 8.53, 95% CI = 3.2-22.47), 7-Fr stent (OR = 18.25, 95% CI = 6.5-50.64), dilated bile duct (mean diameter- 9.2 ± 3.94 mm) (OR = 0.384, 95% CI = 0.18-0.72) and delayed ERCP by > 3 months from index ERCP (OR = 15.28, 95% CI = 8.1-28.49). After performing propensity score matching for age, sex, comorbidities and indication to determine endoscopy-related factors, 7-Fr stent size (OR 3.495; 95% CI-1.23-9.93) and duration of indwelling stent for more than three months (OR-3.37; 95% CI-1.646-6.76) were significantly associated with proximal stent migration. CONCLUSION: Proximally migrated straight stents can be successfully retrieved using standard accessories. The use of 7-Fr size stent, stents indwelling for more than three months, sphincteroplasty at index ERCP, stent length < 10 cm and dilated bile duct were associated with increased risk of proximal migration of straight biliary plastic stents. After propensity score matching, the use of 7-Fr size stents and stent indwelling for over three months were endoscopy-related factors associated with proximal migration.

IgG4-related disorders of the gastrointestinal tract: Experience from a tertiary care centre with systematic review of Indian literature.

INTRODUCTION: IgG4-related disease (IgG4-RD) is a rare disease entity in India. We aimed at studying the clinical profile of IgG4-RD of gastrointestinal tract (GIT) from our centre, while systematically reviewing data from India. METHODS: Retrospective review of IgG4-RD of GIT was done using electronic medical records between January 2013 and July 2022. Literature search was done for studies of IgG4-RD of the GIT reported from India from 2000 till January 2023. Case series, case reports of IgG4-RD of GIT and case reports describing GIT with multi-organ involvement were included in the review. Primary outcome measure was response to treatment. Secondary outcome measure was relapse after remission. RESULTS: Thirty-one patients were included with 71% (22/31) having autoimmune pancreatitis. The diagnosis was achieved on surgical specimen in 35% (11/31) patients. Steroid was given to 64% (20/31) patients with remission achieved in 70% (14/20) patients. Four patients exhibitted response to prolonged course of steroids with maintenance azathioprine. Relapse was seen in four (20%) patients who achieved remission. Of 731 articles screened, 48 studies (four case series and 44 case reports) were included in the literature review. Of 95 patients described, steroids were given to 65.2% (62/95), while surgery was done in 33.6% (32/95). Remission was seen in 96.6% (85/88) with relapse occurring in 11.4% (10/88) patients on follow-up. CONCLUSION: One-third patients of IgG4-RD of GIT are diagnosed after surgery. Response to steroids is good with relapse occurring in up to 12% patients.

Drug-Resistant Helicobacter pylori: Diagnosis and Evidence-Based Approach.

Helicobacter pylori (H. pylori) is the most common chronic bacterial infection, affecting approximately half of the world's population. H. pylori is a Class I carcinogen according to the World Health Organization, and the International Agency for Research on Cancer (IARC) has linked it to 90% of stomach cancer cases worldwide. The overall pattern points to a yearly reduction in eradication rates of H. pylori with the likelihood of success further decreasing after each unsuccessful therapeutic effort. Antimicrobial resistance in Helicobacter pylori is a major public health concern and is a predominant cause attributed to eradication failure. As a result, determining H. pylori's antibiotic susceptibility prior to the administration of eradication regimens becomes increasingly critical. Detecting H. pylori and its antimicrobial resistance has traditionally been accomplished by time-consuming culture and phenotypic drug susceptibility testing. The resistance of H. pylori to different antibiotics is caused by various molecular mechanisms, and advances in sequencing technology have greatly facilitated the testing of antibiotic susceptibility to H. pylori. This review will summarize H. pylori antibiotic resistance patterns, mechanisms, and clinical implications. We will also review the pros and cons of current antibiotic susceptibility testing methods. Along with a comparison of tailored susceptibility-guided regimens and empirical therapy based on the latest evidence, an evidence-based approach to such situations will be explored.

Efficacy of lumen-apposing metal stents for the management of benign gastrointestinal stricture: a systematic review and meta-analysis.

Background: Lumen-apposing metal stents (LAMS) are an evolving option for the management of benign gastrointestinal (GI) strictures. Multiple studies have reported on the efficacy and safety of LAMS for benign GI strictures, but were limited by their small sample size. Hence, we conducted this meta-analysis to assess the critical role of LAMS for the management of benign GI strictures. Methods: A literature search of various databases from inception until October 2022 was conducted for studies evaluating the outcome of LAMS in patients with benign GI strictures. The outcomes assessed included technical and clinical success, adverse events including stent migration, and reintervention. Pooled event rates across studies were expressed with summative statistics. Results: A total of 18 studies (527 patients) were included in the present analysis. The pooled event rates for technical, short-term and long-term clinical success were 99.9% (95% confidence interval [CI] 99.1-100.0), 93.9% (95%CI 90.7-100.0), and 72.8% (95%CI 55.7-90.0), respectively. The pooled incidence of adverse events and stent migration with LAMS for benign GI strictures was 13.5% (95%CI 8.6-18.5) and 10.6% (95%CI 6.0-15.2), respectively. The pooled event rate for reintervention with LAMS for GI strictures was 23.0% (95%CI 15.7-30.3). In a subgroup analysis focusing only on anastomotic strictures there was no significant difference in the pooled event rates for various outcomes. Conclusions: LAMS have a high technical and short-term clinical success rate, with an acceptable safety profile for the management of benign GI strictures. Further studies are needed to determine the appropriate duration of stent therapy and long-term outcomes.

Reliability of Optical Coherence Tomography Angiography Retinal Blood Flow Analyses.

Purpose: Investigate the association between the optical coherence tomography angiography (OCTA) metrics derived from different analysis programs to understand the comparability of studies using these different approaches. Methods: Secondary analysis of a prospective observational study (March 2018-September 2021). Forty-four right eyes and 42 left eyes from 44 patients were included. Patients were either undergoing upper gastrointestinal surgery with a critical care stay planned or were already in the critical care unit with sepsis. OCTA scans were obtained in an ophthalmology department or critical care setting. Fourteen OCTA metrics were compared within and between the programs, and agreement was measured by Pearson's R coefficient and intraclass correlation coefficient. Results: Correlation was highest between all Heidelberg metrics and Fractalyse (all >0.84), and lowest between Matlab skeletonized or foveal avascular zone metrics and all other measures (e.g., skeletal fractal dimension and vessel density at -0.02). Agreement between eyes was moderate to excellent in all metrics (0.60-0.90). Conclusions: The significant variability between metrics and programs used for OCTA analysis demonstrates that they are not interchangeable and supports a recommendation for perfusion density metrics to be reported as standard. Translational Relevance: Agreement between different OCTA analyses is variable and not interchangeable. The high agreement between non-skeletonized vessel density metrics suggests that these should be routinely reported.

Adverse events with EUS-guided biliary drainage: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Multiple meta-analyses have evaluated the technical and clinical success of EUS-guided biliary drainage (BD), but meta-analyses concerning adverse events (AEs) are limited. The present meta-analysis analyzed AEs associated with various types of EUS-BD. METHODS: A literature search of MEDLINE, Embase, and Scopus was conducted from 2005 to September 2022 for studies analyzing the outcome of EUS-BD. The primary outcomes were incidence of overall AEs, major AEs, procedure-related mortality, and reintervention. The event rates were pooled using a random-effects model. RESULTS: One hundred fifty-five studies (7887 patients) were included in the final analysis. The pooled clinical success rates and incidence of AEs with EUS-BD were 95% (95% confidence interval [CI], 94.1-95.9) and 13.7% (95% CI, 12.3-15.0), respectively. Among early AEs, bile leak was the most common followed by cholangitis with pooled incidences of 2.2% (95% CI, 1.8-2.7) and 1.0% (95% CI, .8-1.3), respectively. The pooled incidences of major AEs and procedure-related mortality with EUS-BD were .6% (95% CI, .3-.9) and .1% (95% CI, .0-.4), respectively. The pooled incidences of delayed migration and stent occlusion were 1.7% (95% CI, 1.1-2.3) and 11.0% (95% CI, 9.3-12.8), respectively. The pooled event rate for reintervention (for stent migration or occlusion) after EUS-BD was 16.2% (95% CI, 14.0-18.3; I2 = 77.5%). CONCLUSIONS: Despite a high clinical success rate, EUS-BD may be associated with AEs in one-seventh of the cases. However, major AEs and mortality incidence remain less than 1%, which is reassuring.

The impact of artificial intelligence on retinal disease management: Vision Academy retinal expert consensus.

PURPOSE OF REVIEW: The aim of this review is to define the "state-of-the-art" in artificial intelligence (AI)-enabled devices that support the management of retinal conditions and to provide Vision Academy recommendations on the topic. RECENT FINDINGS: Most of the AI models described in the literature have not been approved for disease management purposes by regulatory authorities. These new technologies are promising as they may be able to provide personalized treatments as well as a personalized risk score for various retinal diseases. However, several issues still need to be addressed, such as the lack of a common regulatory pathway and a lack of clarity regarding the applicability of AI-enabled medical devices in different populations. SUMMARY: It is likely that current clinical practice will need to change following the application of AI-enabled medical devices. These devices are likely to have an impact on the management of retinal disease. However, a consensus needs to be reached to ensure they are safe and effective for the overall population.