Electronic Healthcare Databases Research Articles

Effectiveness and safety of empagliflozin: final results from the EMPRISE study.

Limited evidence exists on the comparative safety and effectiveness of empagliflozin against alternative glucose-lowering medications in individuals with type 2 diabetes with the broad spectrum of cardiovascular risk. The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) cohort study was designed to monitor the safety and effectiveness of empagliflozin periodically for a period of 5 years with data collection from electronic healthcare databases. We identified individuals ≥18 years old with type 2 diabetes who initiated empagliflozin or dipeptidyl peptidase-4 inhibitors (DPP-4i) from 2014 to 2019 using US Medicare and commercial claims databases. After 1:1 propensity score matching using 143 baseline characteristics, we identified four a priori-defined effectiveness outcomes: (1) myocardial infarction (MI) or stroke; (2) hospitalisation for heart failure (HHF); (3) major adverse cardiovascular events (MACE); and (4) cardiovascular mortality or HHF. Safety outcomes included lower-limb amputations, non-vertebral fractures, diabetic ketoacidosis (DKA), acute kidney injury (AKI), severe hypoglycaemia, retinopathy progression, and short-term kidney and bladder cancers. We estimated HRs and rate differences (RDs) per 1000 person-years, overall and stratified by age, sex, baseline atherosclerotic cardiovascular disease (ASCVD) and heart failure. We identified 115,116 matched pairs. Compared with DPP-4i, empagliflozin was associated with lower risks of MI/stroke (HR 0.88 [95% CI 0.81, 0.96]; RD -2.08 [95% CI (-3.26, -0.90]), HHF (HR 0.50 [0.44, 0.56]; RD -5.35 [-6.22, -4.49]), MACE (HR 0.73 [0.62, 0.86]; RD -6.37 [-8.98, -3.77]) and cardiovascular mortality/HHF (HR 0.57 [0.47, 0.69]; RD -10.36 [-12.63, -8.12]). Absolute benefits were larger in older individuals and in those with ASCVD/heart failure. Empagliflozin was associated with an increased risk of DKA (HR 1.78 [1.44, 2.19]; RD 1.59 [1.08, 2.09]); decreased risks of AKI (HR 0.62 [0.54, 0.72]; RD -2.39 [-3.08, -1.71]), hypoglycaemia (HR 0.75 [0.67, 0.84]; RD -2.46 [-3.32, -1.60]) and retinopathy progression (HR 0.78 [0.63, 0.96)]; RD -9.49 [-16.97, -2.10]); and similar risks of other safety events. Empagliflozin relative to DPP-4i was associated with risk reductions of MI or stroke, HHF, MACE and the composite of cardiovascular mortality or HHF. Absolute risk reductions were larger in older individuals and in those who had history of ASCVD or heart failure. Regarding the safety outcomes, empagliflozin was associated with an increased risk of DKA and lower risks of AKI, hypoglycaemia and progression to proliferative retinopathy, with no difference in the short-term risks of lower-extremity amputation, non-vertebral fractures, kidney and renal pelvis cancer, and bladder cancer.

Safety profile of rivaroxaban in first-time users treated for venous thromboembolism in four European countries.

The European rivaroxaban post-authorization safety study evaluated bleeding risk among patients initiated on rivaroxaban or vitamin K antagonists for the treatment and secondary prevention of venous thromboembolism in routine clinical practice. Cohorts were created using electronic healthcare databases from the UK, the Netherlands, Germany and Sweden. Patients with a first prescription of rivaroxaban or vitamin K antagonist during the period from December 2011 (in the UK, January 2012) to December 2017 (in Germany, December 2016) for venous thromboembolism indication, with no record of atrial fibrillation or recent cancer history, were observed until the occurrence of each safety outcome (hospitalization for intracranial, gastrointestinal, urogenital or other bleeding), death or study end (December 2018; in Germany, December 2017). Crude incidence rates of each outcome per 100 person-years were computed. Overall, 44 737 rivaroxaban and 45 842 vitamin K antagonist patients were enrolled, mean age, 59.9-63.8 years. Incidence rates were similar between rivaroxaban and vitamin K antagonist users with some exceptions, including higher incidence rates for gastrointestinal bleeding in rivaroxaban users than in vitamin K antagonist users. Among rivaroxaban users, mortality and bleeding risk generally increased with age, renal impairment and diabetes. This study provides further data from routine clinical practice that broadly support safety profile of rivaroxaban for VTE indication and complement findings from previous randomized clinical trials.

COVID-19 and pregnancy: A European study on pre- and post-infection medication use.

The COVID-19 pandemic has impacted medication needs and prescribing practices, including those affecting pregnant women. Our goal was to investigate patterns of medication use among pregnant women with COVID-19, focusing on variations by trimester of infection and location. We conducted an observational study using six electronic healthcare databases from six European regions (Aragon/Spain; France; Norway; Tuscany, Italy; Valencia/Spain; and Wales/UK). The prevalence of primary care prescribing or dispensing was compared in the 30-day periods before and after a positive COVID-19 test or diagnosis. The study included 294,126 pregnant women, of whom 8943 (3.0%) tested positive for, or were diagnosed with, COVID-19 during their pregnancy. A significantly higher use of antithrombotic medications was observed particularly after COVID-19 infection in the second and third trimesters. The highest increase was observed in the Valencia region where use of antithrombotic medications in the third trimester increased from 3.8% before COVID-19 to 61.9% after the infection. Increases in other countries were lower; for example, in Norway, the prevalence of antithrombotic medication use changed from around 1-2% before to around 6% after COVID-19 in the third trimester. Smaller and less consistent increases were observed in the use of other drug classes, such as antimicrobials and systemic corticosteroids. Our findings highlight the substantial impact of COVID-19 on primary care medication use among pregnant women, with a marked increase in the use of antithrombotic medications post-COVID-19. These results underscore the need for further research to understand the broader implications of these patterns on maternal and neonatal/fetal health outcomes.

The impact of urgency of umbilical hernia repair on adverse outcomes in patients with cirrhosis: a population-based cohort study from England

IntroductionUmbilical hernia is common in patients with cirrhosis; however, there is a paucity of dedicated studies on postoperative outcomes in this group of patients. This population-based cohort study aimed to determine the outcomes after emergency and elective umbilical hernia repair in patients with cirrhosis.MethodsTwo linked electronic healthcare databases from England were used to identify all patients undergoing umbilical hernia repair between January 2000 and December 2017. Patients were grouped into those with and without cirrhosis and stratified by severity into compensated and decompensated cirrhosis. Length of stay, readmission, 90-day case fatality rate and the odds ratio of 90-day postoperative mortality were defined using logistic regression.ResultsIn total, 22,163 patients who underwent an umbilical hernia repair were included and 297 (1.34%) had cirrhosis. More patients without cirrhosis had an elective procedure, 86% compared with 51% of those with cirrhosis (P < 0.001). In both the elective and emergency settings, patients with cirrhosis had longer hospital length of stay (elective: 0 vs 1 day, emergency: 2 vs 4 days, P < 0.0001) and higher readmission rates (elective: 4.87% vs 11.33%, emergency:11.39% vs 29.25%, P < 0.0001) than those without cirrhosis. The 90-day case fatality rates were 2% and 0.16% in the elective setting, and 19% and 2.96% in the emergency setting in patients with and without cirrhosis respectively.ConclusionEmergency umbilical hernia repair in patients with cirrhosis is associated with poorer outcomes in terms of length of stay, readmissions and mortality at 90 days.

Increased risk of decompensated heart failure, acute coronary syndrome, arrythmias and ischemic stroke following exacerbation of COPD: results from a multi-database cohort study

Abstract Introduction The risk of acute coronary syndrome (ACS), stroke or death is increased following an exacerbation of chronic obstructive pulmonary disease (COPD). However, little is known about the risk of decompensated heart failure (HF) or acute arrhythmias. Purpose To quantify the risk of decompensated HF, ACS, acute arrhythmias and ischemic stroke following an exacerbation of COPD. Methods Individuals living with COPD were identified in electronic healthcare and claims databases between 2014 and 2018 in Canada (n=142,787), Germany (n=126,795), the Netherlands (NL, n=8,020) and Spain (n=24,393) and followed until a first non-fatal severe CV event of interest (defined as a hospitalisation for ACS, decompensated HF, arrythmias and ischemic stroke), death or censoring. For each non-fatal severe CV event, a multivariable time-dependent Cox model compared the risk of outcome in the 12 months following the onset of a COPD exacerbation (exposed period, split into granular sub-periods of time) with the risk of outcome during periods outside an exacerbation (unexposed period), providing adjusted hazard ratios (HR) and 95% confidence intervals. Results Mean age ranged between 65-68 years old and more than 50% of patients were male, in all countries (Table 1). Cardiovascular risk factors and diseases were common, with 47% to 91% of patients prescribed cardiovascular medications. During follow-up a non-fatal severe CV event occurred in 11% of patients in Canada, 23% in Germany, 8% in NL and 24% in Spain. Decompensated HF was the most frequent event of interest and accounted for 35% to 47% of non-fatal CV events, except in Canada where ACS accounted for 37% of events. In the first 7 days following an exacerbation, the HR ranged between 2.59 (95% CI, 2.32 - 2.89) and 72.34 (64.43 - 81.22) for decompensated HF; 5.59 (5.09 - 6.15) and 24.57 (21.70 - 27.83) for ACS; 9.16 (8.36 - 10.03) and 31.18 (26.84 - 36.21) for arrythmia (mainly driven by atrial fibrillation); and between 2.22 (1.88 - 2.63) and 16.12 (13.39 - 19.41) for ischemic stroke (Table 2). The risks remained elevated for 6 months for decompensated HF and 30 days for ACS in all countries except NL. Conclusion The risk of all severe CV events, including decompensated HF and arrhythmias, was increased following an exacerbation of COPD. Despite heterogeneity of findings across countries, our results indicate that an exacerbation of COPD should be considered as an important risk factor for cardiopulmonary events, emphasizing the need for optimized COPD management across specialties.

Incidence and risk prediction of post-Covid-19 cardiovascular disease in the general population: a multivariable prediction model development and validation study

Abstract Background Previous studies showed that relative risks of various cardiovascular events are increased after Covid-19, even in non-hospitalized individuals. The global burden of post-Covid-19 cardiovascular disease is large and not (yet) hospitalized Covid-19 infected adults may represent a potential target for prevention strategies to mitigate this burden. However, good estimates of individual absolute risks in the general population and risk stratification models are lacking, yet pivotal to assess its impact and direct health care policy. Purpose This study aimed to assess the absolute risk of post-Covid-19 cardiovascular events in the general population, and subsequently explore individual risk prediction in this domain. Methods Covid-19 diagnosed adults were identified from the United Kingdom’s Clinical Practice Research Datalink Aurum, a primary care electronic healthcare database. We assessed 180-day incidence rates of atherosclerotic events (acute coronary syndrome, stroke and transient ischaemic accident), venous thrombo-embolic events (pulmonary embolism and deep venous thrombosis), and newly diagnosed atrial fibrillation and heart failure. Multivariable logistic regression models using elastic net penalization were developed on a cohort of 220,751 adults with Covid-19 before 1 December 2020 (before the start of national vaccination campaigns). Candidate predictors included age, sex, body mass index, smoking, medical history and medication. Three models were fit for each endpoint, with increasing numbers of predictors. All models were validated in (1) 138,034 vaccinated and (2) 503,404 non-vaccinated adults with a first Covid-19 diagnosis after 1 December 2020. We evaluated discriminative and calibration performance upon internal cross-validation and in both validation cohorts. Results Post-Covid-19 cardiovascular event incidences ranged from 13 (venous thromboembolic events) down to 4 (heart failure de novo) per 1000 person-years. Incidences were relatively increased up to 50 days after Covid-19 infection. However, on an absolute scale, individual risks were very low: only less than one in twenty adults with Covid-19 had a predicted 180-day risk larger than 1% and these mainly included individuals aged 60 years or older. Even though the best models had high discriminative performance (AUC &amp;gt; 0.90), rare outcomes complicated predictive performance and calibration. Conclusions Risks of atherosclerotic events, venous thromboembolic events, and newly diagnosed atrial fibrillation and heart failure are increased after Covid-19 infection in the general population, notably within the first 50 days after infection and in individuals aged 60 years or older. However, individual risks are too low to be predictive or helpful to guide individual risk management. Risk mitigation strategies should therefore be aimed at population-based prevention (such as increasing vaccination uptake) and at individual management of Covid-19 hospitalized patients.Graphical abstractPredicted 180-day risk after Covid-19

Characteristics of patients initiating PCSK9i mAb following myocardial infarction and comparability of treatment groups in the Netherlands

Abstract Background The clinical benefits of lipid lowering treatment (LLT) for reducing risk of atherosclerotic cardiovascular disease (ASCVD) are well established. Recent findings support early initiation of proprotein convertase subtilisin/kexin type 9 inhibitors monoclonal antibodies (PCSK9i mAb) to maximize clinical benefit. However, when comparing treatment effects in a real-world setting, it is important to establish comparability of treatment groups and assess and adjust for confounding. Purpose To compare clinical characteristics and LLT use in patients initiating and not initiating PCSK9i mAb within 365 days following a myocardial infarction (MI). Methods MI events occurring in patients ≥18 years between 1 April 2016 and 31 December 2020 were identified in PHARMO Database Network, a population-based network of electronic healthcare databases linking data from general practitioners, out-patient and in-patient pharmacies and hospitals in the Netherlands. The database has about 3.3 million patients, representative of the Dutch population with respect to age and sex albeit with slight over-representation of those &amp;gt;80 years old. Characteristics of patients were presented by treatment groups: initiating PCSK9i mAb and not initiating PCSK9i mAb within 365 days post-MI. Characteristics and LLT use in the two treatment groups was evaluated. Results Of the 28,975 MI events, 157 (0.5%) initiated a PCSK9i mAb within 365 days. Patients who initiated a PCSK9i mAb within 365 days post-MI were younger than those who did not (median age of 63 versus 69 years), more likely to have a history of ASCVD prior to the MI event (56% versus 39%) and dyslipidaemia (55% versus. 28%), while non-initiators were more likely to have diabetes mellitus, chronic kidney disease and atrial fibrillation (Table). Patients who initiated PCSK9i mAb within 365 days post-MI had higher low-density lipoprotein cholesterol levels (3.7 versus 2.9 mmol/L), higher use of ezetimibe (25% versus 4%) and high-intensity statins (15% vs 11%, Figure). Conclusions In the Netherlands, despite being at very high risk of recurrent ASCVD, based on this dataset excluding Patient Support Programs, fewer than 1% of patients initiated a PCSK9i mAb within 365 days post-MI. Further analyses are needed to reveal if these treatment groups are comparable to assess differences and uncontrolled confounders in cardiovascular outcomes in the real world.

Prediction models for in-hospital deaths of patients with COVID-19 using electronic healthcare data

Objective Many models for predicting various disease prognoses have achieved high performance without laboratory test results. However, whether laboratory test results can improve performance remains unclear. This study aimed to investigate whether laboratory test results improve the model performance for coronavirus disease 2019 (COVID-19). Methods Prediction models were developed using data from the electronic healthcare record database in Japan. Patients aged ≥18 years hospitalized for COVID-19 after February 11, 2020, were included. Their age, sex, comorbidities, laboratory test results, and number of days from February 11, 2020, were collected. We developed a logistic regression, XGBOOST, random forest, and neural network analysis and compared the performance with and without laboratory test results. The performance of predicting in-hospital death was evaluated using the area under the curve (AUC). Results Data from 8,288 hospitalized patients (females, 46.5%) were analyzed. The median patient age was 71 years. A total of 6,630 patients were included in the training dataset, and 312 (4.7%) died. In the logistic regression model, the area under the curve was 0.88 (95% confidence interval [CI] = 0.83–0.93) and 0.75 (95% CI = 0.68–0.81) with and without laboratory test results, respectively. The performance was not fundamentally different between the model types, and the laboratory test results improved the performance in all cases. The variables useful for prediction were blood urea nitrogen, albumin, and lactate dehydrogenase. Conclusions Laboratory test results, such as blood urea nitrogen, albumin, and lactate dehydrogenase levels, along with background information, helped estimate the prognosis of patients hospitalized for COVID-19.

The role of oestrogen therapy in reducing risk of Alzheimer's disease: systematic review.

Studies have shown a relationship between oestrogen and Alzheimer's disease. However, there is neither clear nor strong evidence on the use of oestrogen-only therapy in reducing the risk of Alzheimer's disease. To assess the effects of oestrogen-only therapy on reducing the risk of Alzheimer's disease. Inclusion criteria was determined with the PICO framework. Outcome was cognitive function measured by neuropsychological tests and strict protocols. Exclusion criteria included non-Alzheimer's dementia, progesterone-only therapy and pre-menopausal women. Searches were conducted in nine electronic healthcare databases, last searched in July 2022. Quality assessments conducted on randomised controlled trials (RCTs) were performed with the GRADE assessment, and cohort studies and case-control studies were assessed with the Newcastle-Ottawa Scale. Extracted data were used to analyse participants, interventions and outcomes. Twenty-four studies satisfied the search criteria (four RCTs, nine cohort studies, 11 case-control studies). Fifteen studies showed positive associations for oestrogen-only therapy reducing the risk of Alzheimer's disease, and the remaining nine found no evidence of association. Fifteen studies showed that oestrogen-only therapy effectively reduced the risk of Alzheimer's disease, whereas nine showed no correlation. Studies also investigated oestrogen-related variables such as length of oestrogen exposure, being an apolipoprotein E ε4 carrier and concomitant use of non-steroidal anti-inflammatory drugs, and their role in neuroprotection. This review was limited by the limited ranges of duration of oestrogen treatment and type of oestrogen-only therapy used. In conclusion, oestrogen-only therapy has potential for use in preventing Alzheimer's disease, although current evidence is inconclusive and requires further study.

Dynamic relationship among immediate release fentanyl use and cancer incidence: A multivariate time-series analysis using vector autoregressive models

Background: A substantial increase in the incidence of immediate release fentanyl (IRF) use was reported in Spain from 2012 to 2017. Purpose: This study aimed to investigate the relationship dynamically with cancer incidence in order to provide empirical evidence of inappropriate use of IRF with respect to the pathology. Research design: A vector autoregresive (VAR) model was constructed using data from a nationwide electronic healthcare record database in primary care in Spain (BIFAP) according to the following step procedure: (1) split data into training data for modelling and test for validation (2) assessing for time series stationarity; (3) selecting lag-length; (4) building the VAR model; (5) assessing residual autocorrelation; (6) checking stability of the VAR system; (7) evaluating Granger causality; (8) impulse response analysis and forecast error variance decomposition (9) prediction performance with validation data. Results: The analysis showed a strong and linear correlation between IRF and cancer (Pearson correlation coefficient: 0.594 (95% CI: 0.420–0.726). Two VAR models, VAR (2) and VAR (11) were selected and compared. All tests performed for both models satisfied assumptions for stability, predictability and accuracy. Granger causality revealed cancer incidence is a good predictor for IRF use. VAR (2) seemed to be slightly more accurate, according to the RMSE of the test data. Conclusions: This study demonstrates that using a robust and structured VAR modelling approach, is able to estimate dynamics associations, involving IRF use and cancer incidence.

Outcomes after emergency appendicectomy in patients with liver cirrhosis: a population-based cohort study from England

IntroductionThe mortality risk after appendicectomy in patients with liver cirrhosis is predicted to be higher than in the general population given the associated risk of perioperative bleeding, infections and liver decompensation. This population-based cohort study aimed to determine the 90-day mortality risk following emergency appendicectomy in patients with cirrhosis.MethodsAdult patients undergoing emergency appendicectomy in England between January 2001 and December 2018 were identified from two linked primary and secondary electronic healthcare databases, the clinical practice research datalink and hospital episode statistics data. Length of stay, re-admission, case fatality and the odds ratio of 90-day mortality were calculated for patients with and without cirrhosis, adjusting for age, sex and co-morbidity using logistic regression.ResultsA total of 40,353 patients underwent appendicectomy and of these 75 (0.19%) had cirrhosis. Patients with cirrhosis were more likely to be older (p < 0.0001) and have comorbidities (p < 0.0001). Proportionally, more patients with cirrhosis underwent an open appendicectomy (76%) compared with 64% of those without cirrhosis (p = 0.03). The 90-day case fatality rate was 6.67% in patients with cirrhosis compared with 0.56% in patients without cirrhosis. Patients with cirrhosis had longer hospital length of stay (4 (IQR 3–9) days versus 3 (IQR 2–4) days and higher readmission rates at 90 days (20% vs 11%, p = 0.019). Most importantly, their odds of death at 90 days were 3 times higher than patients without cirrhosis, adjusted odds ratio 3.75 (95% CI 1.35–10.49).ConclusionPatients with cirrhosis have a threefold increased odds of 90-day mortality after emergency appendicectomy compared to those without cirrhosis.

Application of machine learning approaches in predicting clinical outcomes in older adults – a systematic review and meta-analysis

BackgroundMachine learning-based prediction models have the potential to have a considerable positive impact on geriatric care.DesignSystematic review and meta-analyses.ParticipantsOlder adults (≥ 65 years) in any setting.InterventionMachine learning models for predicting clinical outcomes in older adults were evaluated. A random-effects meta-analysis was conducted in two grouped cohorts, where the predictive models were compared based on their performance in predicting mortality i) under and including 6 months ii) over 6 months.Outcome measuresStudies were grouped into two groups by the clinical outcome, and the models were compared based on the area under the receiver operating characteristic curve metric.ResultsThirty-seven studies that satisfied the systematic review criteria were appraised, and eight studies predicting a mortality outcome were included in the meta-analyses. We could only pool studies by mortality as there were inconsistent definitions and sparse data to pool studies for other clinical outcomes. The area under the receiver operating characteristic curve from the meta-analysis yielded a summary estimate of 0.80 (95% CI: 0.76 – 0.84) for mortality within 6 months and 0.81 (95% CI: 0.76 – 0.86) for mortality over 6 months, signifying good discriminatory power.ConclusionThe meta-analysis indicates that machine learning models display good discriminatory power in predicting mortality. However, more large-scale validation studies are necessary. As electronic healthcare databases grow larger and more comprehensive, the available computational power increases and machine learning models become more sophisticated; there should be an effort to integrate these models into a larger research setting to predict various clinical outcomes.

Diagnostic and prognostic performance of the SAFE score in non-alcoholic fatty liver disease.

The steatosis-associated fibrosis estimator (SAFE) score was developed to detect clinically significant liver fibrosis in patients with NAFLD in the United States. We compare the performance of the SAFE score and other non-invasive tests to diagnose liver fibrosis and to correlate the scores with liver-related outcomes in patients with NAFLD in Hong Kong. This was a retrospective cohort study involving two data sets. The first cohort was a biopsy cohort of NAFLD patients (n = 279), and the second was a territory-wide cohort of NAFLD patients (n = 4603) retrieved from a territory-wide electronic healthcare database in Hong Kong. In detecting significant fibrosis, liver stiffness measured by transient elastography had the highest area under the receiver operating characteristic curve (AUROC) (.844), followed by SAFE score (.773). SAFE score had the highest AUROC among blood-based algorithms (.773 vs. .746 for FIB-4, .697 for APRI). Based on cut-off values of SAFE score (0 and 100 points), 854 (18.6%), 1596 (34.6%) and 2153 (46.8%) were in the low-, intermediate- and high-risk groups, respectively, in the territory-wide cohort. Six (.7%), 15 (.9%) and 59 (2.7%) developed liver-related events in those three groups respectively. Among patients who had liver-related events at 5 years, using the high cut-off, SAFE score could predict 84.9% of patients accurately, compared to 40.9% for FIB-4 and 27.2% for APRI. The SAFE score performed well and better than other blood-based markers in diagnosing significant fibrosis and predicting liver-related events in Asian patients with NAFLD.

Artificial intelligence in foot and ankle surgery: current concepts.

The twenty-first century has proven that data are the new gold. Artificial intelligence (AI) driven technologies might potentially change the clinical practice in all medical specialities, including orthopedic surgery. AI has a broad spectrum of subcomponents, including machine learning, which consists of a subdivision called deep learning. AI has the potential to increase healthcare delivery, improve indications and interventions, and minimize errors. In orthopedic surgery. AI supports the surgeon in the evaluation of radiological images, training of surgical residents, and excellent performance of machine-assisted surgery. The AI algorithms improve the administrative and management processes of hospitals and clinics, electronic healthcare databases, monitoring the outcomes, and safety controls. AI models are being developed in nearly all orthopedic subspecialties, including arthroscopy, arthroplasty, tumor, spinal and pediatric surgery. The present study discusses current applications, limitations, and future prospective of AI in foot and ankle surgery.

Trends in Secondary Intraocular Lens Surgery among Vitreoretinal Surgeons

To identify changes in secondary lens techniques over time and to determine common complications of each technique. Retrospective cohort study. All patients in the database from January 2015-December 2021 who underwent secondary lens placement (anterior chamber IOL, scleral fixated IOL, or scleral sutured IOL). Rates of secondary IOL surgery technique were analyzed in 3597 participants in a nationwide aggregated electronic health care database using 2 sample independent T-tests. Rates of post-operative rhegmatogenous retinal detachment (RRD) following secondary IOL surgery were assessed using chi square test of proportion. Post-operative visual acuity was assessed using 2 sample independent T-tests. The primary outcome was change in IOL technique over time. Secondary datapoints examined were the development of post-operative rhegmatogenous retinal detachment (RRD) following secondary IOL surgery, visual acuity changes, the development of endophthalmitis, suture erosion, haptic erosion, or corneal edema following IOL surgery. ACIOL use decreased over the 7-year period from 93% of cases to 36% of cases (p<0.0001), while SFIOL use increased from 3% to 34% (p<0.0001), and SSIOL use increased from 4% to 30% (p<0.0001). Visual acuity increased for each surgical technique (ACIOL: 44.1 vs. 49.2 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, p<0.001; SFIOL: 48.7 vs. 57.6 letters, p<0.001; SSIOL: 51.5 vs. 61.2 letters, p<0.001), with larger visual acuity gains seen in SFIOL and SSIOL use (ACIOL vs. SFIOL, p=0.004; ACIOL vs. SSIOL, p=0.002; SFIOL vs. SSIOL, p=0.64). Average RRD rates did not significantly differ between techniques. Rates of endophthalmitis, haptic erosion, and suture erosion were low and did not significantly differ between techniques. Rates of corneal edema were significantly higher in ACIOL cases (vs. SFIOL, p<0.0001; vs. SSIOL, p<0.0001). Rates of ACIOL implantation performed by vitreoretinal surgeons have decreased over time with more vitreoretinal surgeons electing to place either a SFIOL or SSIOL towards the end of the study period; complication profiles among the three techniques may be similar.

Drug safety signal detection in a regional healthcare database using the tree-based scan statistic and comparison to 3 other mining methods.

To evaluate and compare the relative performance of the tree-based scan statistic (TreeScan) with the crude cohort study, Bayesian confidence propagation neural network (BCPNN) and Gamma Poisson Shrinker (GPS) in detecting statin-related adverse events (AEs) in an electronic healthcare database. Data from a Chinese healthcare database from 2010 to 2016 were evaluated. We identified statin users based on prescription information in their out-/in-patient records, and AEs were defined according to the ICD-10 codes in patients' diagnosis records. TreeScan was applied to detect AE signals related to statin use and was compared with 3 other methods based on sensitivity, specificity, positive predictive value, negative predictive value, accuracy, the Youden index, area under the precision-recall curve and the area under the receiver operating characteristic curve. A total of 224 187 patients were enrolled and divided into 85 758 statin users and 138 429 nonusers. TreeScan generated 29 positive signals, of which 9 were known AEs. The sensitivities of TreeScan, BCPNN and GPS were all 69.2%, which was higher than that of the crude cohort study (46%). The specificity (82.3%), positive predictive value (31.0%), negative predictive value (95.9%), accuracy (81.0%), Youden index (51.5%) and area under the receiver operating characteristic curve (75.8%) of TreeScan were the highest among the 4 methods. TreeScan outperformed the crude cohort, BCPNN and GPS in detecting statin-related AEs in an electronic healthcare database. Therefore, it can be used as a complementary tool for other signal detection methods in drug safety surveillance.

Healthcare-associated Stenotrophomonas maltophilia infections in the United States, 2018–2022

Background:Stenotrophomonas maltophilia is an important cause of opportunistic healthcare-associated infections (HAIs) in critically ill patients and is difficult to treat due to intrinsic resistance to multiple antibiotic classes. During the COVID-19 pandemic, the CDC received anecdotal reports of increases in S. maltophilia respiratory infections. To further investigate these reports, we used a national electronic healthcare database to evaluate changes in S. maltophilia during the pandemic. Methods: Using the PINC-AI healthcare data (Premier Inc, Charlotte, NC) we identified all potential HAIs by calculating the total number of unique patients hospitalized during January 1, 2018, through December 31, 2021, who had any organism isolated on clinical culture obtained &gt;3 days after admission. We calculated the proportion of patients with S. maltophilia detected in culture and stratified them by specimen source. To determine whether COVID-19 diagnosis influenced the proportion of patients diagnosed with S. maltophilia respiratory infections during the pandemic (January 1, 2020–December 31, 2021), we calculated the proportion of patients with S. maltophilia detected among those with any bacterial pathogen isolated from a respiratory culture &gt;3 days after hospitalization. We stratified these results by presence or absence of concurrent COVID-19 diagnosis. Pearson χ2 test was used to test for differences where appropriate. Results: Among hospitalized patients with any organism isolated from a clinical culture, the proportion with S. maltophilia detected was higher in 2021 (n = 2,554 of 118,029, 2.2%) than in 2018 (n = 2,063 of 155,624, 1.3%) p 3 days after hospital admission from 2018 to 2021. Most patient isolates were from respiratory specimens. A concurrent diagnosis of COVID-19 did not appear to increase the likelihood of respiratory S. maltophilia detection. The increases in S. maltophilia during the pandemic might be explained by challenges inherent to caring for increased numbers of higher-acuity patients during this time, including staffing shortages and changes to infection prevention practices. Additional exploration of these data, as well as data from other sources and from additional years, may help to elucidate this issue more fully.Disclosures: None

Risk of hospitalization for upper gastrointestinal bleeding in Helicobacter pylori eradicated patients newly started on warfarin or direct oral anticoagulants: A population-based cohort study.

To investigate risks of hospitalization for upper gastrointestinal bleeding (UGIB) in H. pylori-eradicated patients newly started on warfarin or direct oral anti-coagulants (DOACs). We identified all patients who had previously received H. pylori eradication therapy or were found to have no H. pylori on endoscopy and were then newly started on warfarin or DOACs from a population-based electronic healthcare database. Primary analysis was the risk of UGIB between warfarin and DOACsusers in H. pylori-eradicated patients. Secondary analysis included the UGIB risk between H. pylori-eradicated and H. pylori-negative patients who were newly started on warfarin or DOACs. The hazard ratio (HR) of UGIB was approximated by pooled logistic regression model incorporating the inverse propensity of treatment weightings with time-varying covariables. Among H. pylori-eradicated patients, DOACs had a significantly lower risk of UGIB (HR: 0.26, 95% CI 0.09-0.71) compared with warfarin. In particular, lower UGIB risks with DOACs were observed among older (≥65 years) patients, female, those without a history of UGIB or peptic ulcer, or ischemic heart disease, and non-users of acid-suppressive agents or aspirin. Secondary analysis showed no significant difference in UGIB risk between H. pylori-eradicated and H. pylori-negative patients newly started on warfarin (HR: 0.63,95% CI 0.33-1.19) or DOACs (HR: 1.37, 95% CI 0.45-4.22). In H. pylori-eradicated patients, new users of DOACs had a significantly lower risk of UGIB than new warfarin users. Furthermore, the risk of UGIB in new warfarin or DOACs users was comparable between H. pylori-eradicated and H. pylori-negative patients.

Brief Report: Use and Side Effects of Sodium-Glucose Transporter 2 Inhibitors Among US People With HIV With Clinical Indications.

Sodium-glucose transporter 2 (SGLT2) inhibitors have been approved for treatment of diabetes mellitus (DM), chronic kidney disease, and heart failure, but little is known about prescription levels and safety profiles among people with HIV (PWH). We leveraged data from the US Mass General Brigham electronic healthcare database to determine the use/uptake of SGLT2 inhibitors among PWH with type II diabetes (DM2) (with or without chronic kidney disease, proteinuria, or heart failure) and to assess rates of adverse events among PWH with DM2 taking SGLT2 inhibitors. Among eligible PWH with DM2 receiving care at US Mass General Brigham (N = 907), SGLT2 inhibitors were prescribed to 8.8%. SGLT2 inhibitors were prescribed to a fraction of eligible PWH with DM2 and a concomitant diagnosis of chronic kidney disease (3.8%), proteinuria (13.2%), or heart failure (8.2%). PWH with DM2 on SGLT2 inhibitors experienced side effects (urinary tract infection, diabetic ketoacidosis, and acute kidney injury) at rates comparable with PWH with DM2 prescribed glucagon-like peptide-1 agonists. Rates of mycotic genitourinary infections were higher among those prescribed SGLT2 inhibitors (5% vs. 1%, P = 0.17), but no cases of necrotizing fasciitis ensued. Additional studies are needed to characterize population-specific salutary and adverse effects of SGLT2 inhibitors among PWH and potentially augment prescription rates when guideline indicated.

O151 A comparison of pathological TNM 7 with TNM 8 staging for pancreatic ductal adenocarcinoma and distal cholangiocarcinoma

Abstract Background The 8th edition of the TNM (tumour, nodes and metastasis) staging system was introduced in 2016 to improve the prognostic prediction of pancreatic ductal adenocarcinoma (PDAC). However, its superiority over the previous edition remains uncertain. This study evaluated the prognostic impact of TNM 7 with TNM 8 staging in patients with PDAC and distal cholangiocarcinoma. Methods A retrospective cohort study was conducted using electronic healthcare databases at a tertiary hepatobiliary centre in the UK. Kaplan-Meier survival curves were used to evaluate the prognostic prediction of TNM 7 and TNM 8 staging. The concordance index was calculated to assess the discriminatory power of both systems. Crosstabulation of T, N and overall staging was performed to determine which staging system stratified patients more effectively. Results The study identified 194 patients and found the overall median survival after resection to be 1.86 years. The concordance index for TNM 7 [0.634; 95% confidence intervall(CI) 0.586-0.682)], was similar to TNM 8 (0.633; 95% CI 0.584-0.683). TNM 8 showed improved stratification of patients for the T (p=0.001), N (p=0.001) classifications and overall staging system (p=0.001). However, in TNM 8, the new N2 stage had a similar survival prediction to N1. Conclusion There was no significant difference in the prognostic prediction between the TNM 7 and TNM 8 systems for PDAC and distal cholangiocarcinoma. While TNM 8 improved patient stratification across T staging, our findings found the introduction of the N2 staging to be unnecessary as its survival prediction was comparable to N1.