Retrospective Database Analysis Research Articles

Influence of smoking on patient-reported outcome measures (PROMs) in patients undergoing surgery for adult spinal deformity: a propensity score-matched analysis.

The purpose of this study was to determine the isolated influence of smoking in patient-reported outcome measures (PROMs) for adult spinal deformity (ASD) surgery excluding known tobacco-related complications. Retrospective analysis of a prospective multicenter ASD database. Patients operated on ASD with 2year post-operative follow-up were included. Former smokers (non-active smokers) and patients developing mechanical or infectious complications were excluded. Changes of PROMs over time were analyzed using mixed models for repeated measures (MMRM). Propensity score matching (PSM) (1:1 ratio, caliper 0.10) was performed without replacement using optimum algorithm, tolerance ≤ 0.001, and estimated with 95% confidence interval (CI). PROMS in both groups were compared by paired t test or Wilcoxon signed-rank test. 692 out of 1246 surgical patients met our inclusion criteria. 153 smokers were matched with 153 non-smokers according to age, BMI, number of fused levels, and global tilt. After PSM both groups were homogeneous regarding baseline parameters, surgical data, and complications (mechanical complications and infection excluded). Smokers had worse baseline results for SRS-total, SRS-pain COMI-back, and ODI; smokers also showed worse 2-year outcomes for SRS-total, SRS-function, SRS-pain, SRS-self-image, and ODI. However, no differences between the two groups were found in the improvement from baseline to 2-year follow-up or in the timing of this improvement (MMRM). The proportion of patients reaching the minimal clinically important difference (MCID) after surgery was similar in the two groups, but the proportion of patients reaching patient acceptable symptom state (PASS) was significantly lower in smokers for SRS-Subtotal, SRS-function, and SRS-image. Even in the absence of smoking-related complications, smokers had worse PROMs at baseline and 2 years after surgery with less patients achieving PASS, but similar degrees on improvement compared to non-smokers. The proportion achieving MCID was also similar between the two cohorts.

WEIGHT BEAR THEN DISCHARGE: A SAFE MANAGEMENT STRATEGY FOR ISOLATED WEBER B LATERAL MALLEOLUS FRACTURES. OUTCOMES OF 658 PATIENTS

Myriad protocols exist for isolated Weber B lateral malleolus fractures with a congruent tibiotalar joint on initial radiographs. Stress and weight-bearing radiographs, all at various timepoints, may be employed to identify those injuries that develop significant talar shift but consensus is elusive. This study outlines a safe and reproducible protocol for such injuries, utilising a removable orthosis, immediate weight bearing and standard supine radiographs.A retrospective analysis of a prospective trauma database was analysed to identify patients with an isolated Weber B ankle fracture with adequate presentation radiographs demonstrating a congruent mortise. Patient records and radiographs were evaluated a minimum of 5 years after initial presentation to determine ankle stability, complications, and the burden on outpatient services.Between 2014 and 2016, 657 patients were referred to the specialist trauma clinic from the emergency department. Of the 657, 52 patients had inadequate ED radiographs to determine ankle congruity. At the two-week assessment, 11 of the 52 demonstrated talar shift and required intervention. Therefore 646 patients demonstrated ankle congruity at two weeks after weight bearing. No patient demonstrated talar shift at the six-week assessment. Average number of follow up appointments was 2.4 with 3.5 radiographs. Our new treatment protocol advocates discharge after a single orthopaedic assessment after two weeks of weight bearing.This study supports immediate weight-bearing of Weber B ankle fractures with a congruent mortise in an orthosis. Follow up beyond two weeks is unnecessary and our protocol offers a safe means of significantly reducing the outpatient burden.

Risk of potential hepatotoxicity from pirfenidone or nintedanib in patients with idiopathic pulmonary fibrosis: results of a retrospective analysis of a large insurance database in Taiwan.

Background: A growing population of individuals diagnosed with idiopathic pulmonary fibrosis (IPF) are receiving treatment with nintedanib and pirfenidone. The aim of our study was to assess the incidence of drug-induced liver injury (DILI) associated with the use of pirfenidone and nintedanib in patients with IPF in Taiwan. Methods: We collected a cohort of adult patients diagnosed with IPF between 2017 and 2020. The research outcomes involved assessing the incidence of DILI in patients treated with nintedanib or pirfenidone. Poisson regression analysis was employed to estimate incidence rates, with and without adjustments for covariates, to calculate and present both unadjusted and adjusted incidence rate ratios (IRRs). Results: The risk of DILI was greater in patients who received nintedanib than in those who received pirfenidone during the 1-year follow-up. Patients treated with nintedanib exhibited a heightened risk of DILI based on inpatient diagnoses using specific codes after adjusting for variables such as gender, age group, comorbidities and concomitant medications, with an adjusted incidence rate ratio (aIRR) of 3.62 (95% confidence interval (CI) 1.11-11.78). Similarly, the risk of DILI was elevated in patients treated with nintedanib according to a per-protocol Poisson regression analysis of outcomes identified from inpatient diagnoses using specific codes. This was observed after adjusting for variables including gender, age group, comorbidities, and concomitant medications, with an aIRR of 3.60 (95% CI 1.11-11.72). Conclusion: Data from postmarketing surveillance in Taiwan indicate that patients who received nintedanib have a greater risk of DILI than do those who received pirfenidone.

Kidney Failure Events, Cardiovascular Disease Events, and All-Cause Mortality in Patients with IgA Nephropathy in a Real-World Database.

IgA nephropathy (IgAN) associated glomerular injury leads to proteinuria, hematuria, and progressive loss of glomerular filtration rate, with progression to kidney failure (KF). This retrospective study evaluated the prognostic effects of proteinuria and progression to KF on cardiovascular disease (CVD)/mortality events and KF/mortality events in the United States. We conducted a non-interventional, retrospective cohort study in adult IgAN patients using Optum's de-identified Market Clarity Data (01/01/2007 to 03/31/2021). Adult (≥18 years old) patients with at least two signs, disease, symptoms natural language processing term entries for IgAN, within 180 days and ≥30 days apart within the identification period were included. Outcomes were assessed by time-dependent proteinuria (≥1 g/day vs. <1 g/day) and KF status (pre vs. post). Descriptive statistics were used for categorical and continuous variables. Multivariable Cox proportional hazard models with time-dependent predictors were used to estimate differences across groups. Pre-KF patients with proteinuria ≥1 g/day were more likely to have a CVD/mortality event during follow-up (adjusted hazard ratio [HR; 95% CI]: 1.80 [1.12-2.89]; p<0.001) or a KF/mortality event (adjusted HR [95% CI]: 2.10 [1.73-2.56]; p<0.001). Post-KF patients were more likely to have a CVD/mortality event during follow-up (adjusted HR [95% CI]: 3.28 [2.82-3.81]; p<0.001). Elevated proteinuria and progression to KF was associated with higher risk of CVD/mortality events. Elevated pre-KF proteinuria was also associated with progression to KF/mortality events. Based on our real-world retrospective database analysis, we hypothesize that novel IgAN therapies that reduce proteinuria and slow the rate of progression to KF have the potential to reduce CVD risk, improve kidney outcomes and prolong/increase overall survival.

First generation antipsychotic-associated serious adverse events in women: a retrospective analysis of a pharmacovigilance database.

Women have been under-represented in trials of antipsychotic medications. Our primary objective was toevaluate five adverse events (AE) associated with first-generation antipsychotics (FGAs) among women relative to menthrough an analysis of the FDA Adverse Event Reporting System (FAERS). We queried 24.6 million AE reports from 2000 to 2023 involving FGAs. The study cohort consisted of chlorpromazine (n = 3317), fluphenazine (n = 1124), haloperidol (n = 16,709), loxapine (n = 3151), perphenazine (n = 816), thioridazine (n = 665), thiothixene (n = 244), and trifluoperazine (n = 360). Cases of neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), Torsades de Pointes (TdP), agranulocytosis (AG), and cerebrovascular adverse events (CVAE) were identified. Reporting odds ratios (ROR) and associated 95% confidence intervals (CI) were calculated with logistic regression for each AE among women relative to men. A total of 2,857 serious AEs were evaluated in the study cohort (NMS = 1810, TD = 434, TdP = 260, AG = 149, CVAE = 204). The ROR for women compared to men was 0.79 (95% CI, 0.71-0.87) for NMS, 0.83 (0.68-1.01) for TD, 1.21 (0.94-1.53) for TdP, 0.71 (0.51-0.98) for AG, and 0.91 (0.68-1.19) for CVAE. A secondary analysis revealed a higher odds in women compared to men of hospitalization associated with reports of TD (ROR = 1.95, 1.29-2.94) and death associated with reports of AG (ROR = 2.46, 1.15-5.24). A subgroup analysis of haloperidol revealed an ROR = 1.67 (1.26-2.21) for women relative to men for TdP. The subgroup analysis of haloperidol AEs revealed a significantly higher reporting odds ratio for TdP. Additionally, the secondary study findings suggest that women were more vulnerable to worse outcomes associated with certain AEs of FGAs.

Haemodynamic response to pre-hospital emergency anaesthesia in trauma patients within an urban helicopter emergency medical service.

Pre-hospital emergency anaesthesia is routinely used in the care of severely injured patients by pre-hospital critical care services. Anaesthesia, intubation, and positive pressure ventilation may lead to haemodynamic instability. The aim of this study was to identify the frequency of new-onset haemodynamic instability after induction in trauma patients with a standardised drug regime. A retrospective database analysis was undertaken of all adult patients treated by a physician-led urban pre-hospital care service over a 6-year period. The primary outcome measure was the frequency of new haemodynamic instability following pre-hospital emergency anaesthesia. The association of patient characteristics and drug regimes with new haemodynamic instability was also analysed. A total of 1624 patients were included. New haemodynamic instability occurred in 231 patients (17.4%). Patients where a full-dose regime was administered were less likely to experience new haemodynamic instability than those who received a modified dose regime (9.7% vs 24.8%, p < 0.001). The use of modified drug regimes became more common over the study period (p < 0.001) but there was no change in the rates of pre-existing (p = 0.22), peri-/post-anaesthetic (p = 0.36), or new haemodynamic instability (p = 0.32). New haemodynamic instability within the first 30min following pre-hospital emergency anaesthesia in trauma patients is common despite reduction of sedative drug doses to minimise their haemodynamic impact. It is important to identify non-drug factors that may improve cardiovascular stability in this group to optimise the care received by these patients.

International trends in pulmonary hypertension mortality between 2001 and 2019: Retrospective analysis of the WHO mortality database

BackgroundThere are limited published data on mortality trends in pulmonary hypertension (PH) worldwide. The objective of this study was to assess the PH-related mortality and time trends in the general population over the past 20 years. Material and methodsWe used country-level PH mortality data from the World Health Organization (WHO) mortality database (2000–19), using the International Classification of Diseases, tenth revision (ICD-10) codes (I27.0, I27.2, I27.8, or I27.9). The average annual percentage changes (AAPCs) were calculated to describe mortality trends. ResultsFifty-four countries were included in this study. Between 2017 and 2019, the average age-standardized death rates (per 100,000) were 0.80 and 0.87 for males and females, respectively. Joinpoint analyses revealed a decreasing PH mortality trend for the overall population from 2000 to 2019 (AAPC -3.2 [95% confidence interval (CI) −4.1 to −2.4]), which was consistent between males and females (males: AAPC -5.3 [95% CI –6.2 to −4.4], females: AAPC -1.7 [95% CI –2.4 to −0.9]). When the estimates were stratified by etiology, we found that the mortality rates from idiopathic pulmonary arterial hypertension (I27.0) and pulmonary heart disease (unspecified, I27.9) had decreased significantly, while the mortality rates in other secondary PH (I27.2) and other specified pulmonary heart diseases (I27.8) had significantly increased. In addition, there were substantial differences in mortality rates and time trends across countries. ConclusionAlthough an overall decrease in PH mortality trends over the past two decades, there were substantial differences across countries. For countries with high or rising mortality rates, more efforts are needed to reduce the mortality.

Abstract WP204: Impact of Reperfusion Grade and First Pass Effect in Large vs Small Core Patients Undergoing Mechanical Thrombectomy

Introduction: While patients with small core stroke (SCS) and large core stroke(LCS) benefit from Mechanical Thrombectomy(MT), the impact of reperfusion (Thrombolysis in Cerebral Infarction (eTICI) grade and the first pass effect (FPE)) on clinical outcomes remains poorly understood. We aim to study the interplay between these factors in LCS and SCS patients. Methodology: Retrospective analysis of a comprehensive stroke center prospective database for patients with MCA-M1 or ICA-T occlusions who underwent MT between November 2010-March 2023. Logistic regression models assessed ASPECTS and eTICI score relationships and their impact on outcomes, adjusted for age, NIHSS, tPA, hypertension, general anesthesia and clot location. Results: Of 1548 included patients (mean age 65±16 years, 50.0% males)Table 1, 9.1%(141/1548) were categorized as a LCS (ASPECTS 0-5: 3.5% ASPECTS 0-2 and 96.0% 3-5) while 90.9%(1407/1548) as a SMC (53.0% ASPECTS 6-8 and 47.0% ASPECTS 9-10)(Table1). Lower rates of FPE were achieved in the LCS cohort (26%) compared to the SCS cohort (36%). First pass effect had comparable relative impact on independence rates on LCS and SCS (Figure1A; p&gt;0.05). Final reperfusion rates were comparable LCS and SCS cohorts; In LCS, 5%, 11%, 26%, and 49% achieved eTICI grades 0-2a, 2b50, 2b67, and 2c-3, while in SCS, the percentages were 5.3%, 11%, 18%, and 66%. The relative benefit of final eTICI2c-3 vs 2b50 was comparable between LCS and SCS (p&gt;0.05;Figure1B) Conclusion: The magnitude of benefit of achieving FPE as well as final full reperfusion (eTICI2c-3 vs eTICI2b) is comparable in large and smaller core strokes.

Abstract WMP96: When to Change? Altering Strategies in Mechanical Thrombectomy May Impact Reperfusion Rates

Introduction: Earlier and greater reperfusion in mechanical thrombectomy (MT) leads to better clinical outcomes. The timing and potential benefit of switching thrombectomy techniques after failed device passes remains unclear. Methods: Retrospective analysis of a prospective comprehensive stroke center database including patients with intracranial ICA, MCA M1/M2, or Basilar occlusions undergoing MT with either Stent-Retriever (SR), Contact Aspiration (CA) or Combined technique (CT) from 2015 to 2023. Our primary endpoint was complete/near-complete reperfusion (eTICI 2c-3) at pass #2 (after pass #1 failure). Secondary endpoints included 1) eTICI2b-3 at pass#2, and 2) eTICI2c-3 with pass #3 (following failure in two consecutive passes with the same technique). We used logistic or Firth regression to compare reperfusion rates and Kaplan-Meier analysis for cumulative rates. Results: Among 3130 MTs in the study period, 1810 met inclusion criteria. Median age [IQR] was 65 [55 - 76] years and 51.5% were male. Following a failed first pass, switching from CA to either CT or SR was associated with higher eTICI 2c-3 (aOR [95%CI] 2.8 [1.3 - 6.5] and 7.4 [1.4-54.8], respectively). Changing from CT or SR to any other technique was not associated with higher reperfusion. Secondary endpoint analysis for eTICI2b-3 yielded comparable results. For the third pass, switching to CT after two repeated failed SR or two repeated failed CA attempts was associated with higher eTICI 2c-3 as compared to repeating the original strategy (SR aOR 5.8 [1.4 - 33.3]; AC aOR 5.6 [1.1 - 41.2]). We did not observe benefit in switching to alternative technique following one or two consecutive passes with CT. After three repeated attempts with the same technique, CT led to greater eTICI 2c-3 as compared to SR and CA (83% vs. 72% vs. 64%, p &lt; 0.001). Conclusions: While limited by small subgroup sample sizes, our study strengthens the hypothesis that early changes in MT technique may have an impact on reperfusion. Our data indicates that if CA fails on first pass, transition to SR or CT should be considered. After two failed consecutive SR or CA passes, transition to CT should be contemplated.

Self-harm by single- and multi-agent medication poisoning in a retrospective analysis of a Poison Control Center database from January 2018 to December 2022.

Medication poisoning is the most common method of self-harm. Longitudinal studies incorporating pre- and post-COVID-19 pandemic data are required to describe the phenomenon and to evaluate the long-term impact on mental health. Calls to the Poison Control Center of Policlinico Umberto I Hospital - Sapienza University of Rome, Italy, were analyzed retrospectively for characteristics and clinical presentation of cases of interest from January 2018 to December 2022. A total of 756 cases of self-harm by medication poisonings were recorded in the study period. A reduction in rate of cases in 2020 was followed by a return to pre-pandemic levels by 2021. When separately analyzing single- and multi-agent cases, occurrence of cases involving just one medication increased since early 2021, with a peak in 2022 (7.8% of total calls, 95% CI 6.2-9.5, from 4.9%, 95% CI 4.1-5.8 in 2018). This increase in the rate of cases, mostly of none or mild severity, was driven by youth aged 12-21, in which the relative proportion of single- versus multi-agent cases showed an increasing trend since 2020 (from 42.6% in 2018 to 78.6% in 2022). Acetaminophen was the medication most frequently involved and benzodiazepines the largest class. A psychiatric background was increasingly seen in 2022, especially in age group 12-21. Single-agent medication self-harm may be an increasingly prevailing phenomenon. Young adolescents with a psychiatric background might be most vulnerable to this behavior in the COVID-19 pandemic aftermath. Healthcare professionals should expect favorable clinical outcome and improve both counseling and psychotherapy supervision in individuals at risk.

Association of socioeconomic status with the management outcome of unruptured intracranial arteriovenous malformation.

The longitudinal management of unruptured brain arteriovenous malformation (bAVM) is crucial. To date, no study in the United States has evaluated the impact of socioeconomic status (SES) on bAVM outcome. Herein, the authors aimed to clarify the impact of SES, as indicated by the area deprivation index (ADI), on bAVM outcome. A retrospective analysis of an institutional bAVM database was conducted. Non-hereditary hemorrhagic telangiectasia patients with a single unruptured bAVM in the period from 1990 to 2021 were included in the analysis. The ADI was categorized as low (ADI ≤ 15th percentile), mid (15th percentile < ADI < 85th percentile), and high (ADI ≥ 85th percentile), with a low ADI indicating the most advantaged group. Patient baseline and follow-up data were analyzed. The primary outcome of interest was nonindependence (modified Rankin Scale [mRS] score > 2) at the last follow-up. A multivariable logistic regression model was performed. A total of 589 patients with unruptured bAVMs were included in the study. The mean patient age at diagnosis was 37.2 years, and 283 patients (48.0%) were male. Of the bAVMs, 238 (40.4%) had a low Spetzler-Martin grade (SMG < III), 194 (32.9%) had a moderate grade (SMG III), and 157 (26.7%) had a high grade (SMG > III). Sixty-nine patients (11.7%) were in the low-ADI group, 476 (80.8%) in the mid-ADI group, and 44 (7.5%) in high-ADI group. Increasing age (OR 1.02, 95% CI 1.01-1.04, p < 0.001), poor baseline mRS score (OR 3.27, 95% CI 1.32-7.88, p = 0.008), treatment with surgery plus radiosurgery with or without embolization (OR 3.21, 95% CI 1.03-9.81, p = 0.041), mid SMG (OR 1.94, 95% CI 1.11-3.44, p = 0.021), high SMG (OR 2.08, 95% CI 1.13-3.88, p = 0.020), longer follow-up (OR 1.05, 95% CI 1.03-1.08, p < 0.001), and mid ADI (OR 3.08, 95% CI 1.34-8.39, p = 0.015) were significantly associated with a poor outcome. A high ADI tended toward a poor outcome (OR 2.93, 95% CI 0.92-9.88, p = 0.071). Eventual obliteration of a bAVM was the only protective predictor of poor outcome (OR 0.55, 95% CI 0.30-0.98, p = 0.046). This study revealed that relatively disadvantaged patients with unruptured bAVMs are more likely to experience nonindependent outcomes at the last follow-up, after adjusting for confounding variables. An emphasis on social support may be beneficial for patients with a lower SES.

Hospital consumption of direct oral anticoagulants in regions of the Russian Federation in 2017–2022

The aim of the study was to investigate the dynamics of inpatient consumption of direct oral anticoagulants in different regions of the Russian Federation for the period from 2017 to 2022.Materials and methods. This study is a non-interventional, retrospective analysis of the electronic database records of Cursor Marketing LLC (Russia) about the announced by medical organizations and executed contracts for the purchase of direct oral anticoagulants (DOACs). The сonsumption was calculated on the basis of a DDD (defined-daily-dose) and estimated DDDTID (defined-daily-dose/1000-inhabitants/day) for each DOACs: rivaroxaban, dabigatran and apixaban. The Rosstat database available on its official website were used as a source of inhabitants data for the Russian regions.Results. A total of 57 866 records were entered into the analyzed databases of Cursor Marketing LLC (Russia) from 2017 to 2022, 47.38% of which indicated rivaroxaban as the drug being procured, 26.51% indicated dabigatran, and 26.11% indicated apixaban. Edoxaban was not procured by healthcare organizations. During the period investigated, there was an increase in the consumption of all DOACs studied, with a higher increase for apixaban (by an average of 284.6% per year), then rivaroxaban (by 144.8% per year) and, to a lesser extent, dabigatran (by 92.5% per year). The analysis of DOACs consumption in general showed that compared to 2017, the need for these drugs in medical organizations in 2022 increased by 18 times. The Urals Federal District consistently exceeds the national average in terms of DDTID consumption. Noteworthy is the consumption dynamics of the regions of the Central Federal District and the North-Western Federal District, which made it possible to achieve DDDTID values above the national average for 5 out of 6 observation years. The lowest rates of DOACs consumption were observed in the Volga Federal District, which, despite positive growth dynamics, failed to reach the national average values. A high level of consumption (&gt;10 DDDTID) of rivaroxaban was noted for the Arkhangelsk region (2018) and the Nenets Autonomous District (in 2021), dabigatran – only for the Arkhangelsk region (in 2018). Many more regions reached high levels of the apixaban consumption, especially in 2021.Conclusion. Despite a number of limitations, the data on the volume of DOACs procurement can be used in the analysis of the consumption at both regional and national levels. When analyzing the DOACs consumption, the impact of COVID-19 pandemic and pharmacogenetic features of patients in different regions should be taken into account. During the studied period of time, a significant part of the Russian regions achieved a consumption level of rivaroxaban and apixaban, but not dabigatran, exceeding 1 DDDTID.

Impact of direct ICU admission of pneumococcal meningitis in France: a retrospective analysis of a French medico-administrative (PMSI) database

BackgroundCurrent guidelines for adult patients with pneumococcal meningitis (PM) recommend initial management in intermediate or intensive care units (ICU), but evidence to support these recommendations is limited. We aimed to describe ICU admission practices of patients with PM.MethodsWe conducted a retrospective analysis of the French medico administrative database of consecutive adult patients with PM and sepsis criteria hospitalized between 2011 and 2020. We defined two groups, “Direct ICU” corresponding to a direct ICU admission and “Delayed ICU” corresponding to a secondary ICU admission.ResultsWe identified 4052 patients hospitalized for a first episode of PM, including 2006 “Direct ICU” patients (50%) and 2046 “delayed ICU” patients (50%). The patients were mainly males [n = 2260 (56%)] with median age of 61 years [IQR 50–71] and a median Charlson index of 1 [0–3]. Among them, median SAPS II on admission was 46 [33–62], 2173 (54%) had a neurological failure on admission with 2133 (53%) in coma, 654 (16%) with brainstem failure, 488 (12%) with seizures and 779 (19%) with focal signs without coma. PM was frequently associated with pneumonia [n = 1411 (35%)], and less frequently with endocarditis [n = 317 (8%)]. The median ICU length of stay and hospital length of stay were 6 days [2–14] and 21 days [13–38], respectively. In-hospital mortality was 27% (n = 1100) and 640 (16%) patients were secondarily transferred to rehabilitation care unit. Direct ICU group was significantly more severe but after adjustment for age, sex, comorbidities, organ failures on admission and admission from home, direct ICU admission was significantly associated with a lower mortality (Odds ratio 0.67 [0.56–0.80], p < 0.01). This corresponded to one death avoided for 11 PM directly admitted in ICU.ConclusionsAmong patients with PM and sepsis, direct ICU admission was associated with lower mortality rates when compared to delayed admission.

P986 Effectiveness of the adjuvanted recombinant zoster vaccine (RZV) in preventing herpes zoster (HZ) among patients ≥50 years of age with Inflammatory Bowel Disease in the United States: A retrospective real-world database analysis from 2018 to 2021

Abstract Background Patients with inflammatory bowel disease (IBD) are at higher risk of developing HZ compared to general population.1 The US Food and Drug Administration (FDA) approved RZV for adults ≥50 years of age (YOA) in Oct 2017 and for adults ≥18 YOA who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression, as patients with IBD, in Jul 2021. This study addresses an information gap for RZV vaccine effectiveness (VE) in preventing HZ among IBD patients ≥50 YOA. Methods We conducted a retrospective matched cohort study using the Optum Clinformatics Data Mart healthcare administrative claims database from Jan 2018 to Dec 2021. Patients ≥50 YOA with IBD who received 2 RZV doses with dose interval ≥28 days (RZV [2-dose] cohort) were 1:3 matched to their unvaccinated counterparts (non-RZV cohort) by age, medication category, and other confounders (propensity score). The index date for RZV cohort was the date of the second dose and for non-RZV cohort was the same index date as their vaccinated match. Follow-up started from index date +30 days until earliest date of HZ occurrence, end of enrolment, death, receipt of HZ vaccine, or study end. The first HZ episode during follow-up was identified using an algorithm that included ICD-10 diagnosis code, inpatient or outpatient claims and/or HZ antiviral medication used within 7 days pre/post-HZ diagnosis. Incidence rates (IRs) of HZ were calculated overall, stratified by condition (ulcerative colitis [UC], Crohn’s disease [CD]) and age. Cox hazards models were used to estimate overall and stratified hazard ratios (HRs). VE (%) was calculated as (1−HR) × 100. A similar approach was used to evaluate VE for patients who received 1 RZV dose. Results We identified 6501 RZV vaccinated and 19962 matched unvaccinated IBD patients who were included in the 2-dose analysis (Table). The IR of HZ was 2.92/1000 person-years (PY) in the RZV cohort and 10.96/1000 PY in the non-RZV cohort, resulting in a VE of 73.4% (95% confidence intervals [CIs]: 60.8-82.0) for IBD patients (Figure). VE against HZ was 63.5% (95%CIs: 43.0-76.6) and 85.7% (95%CIs: 69.5-93.3) in UC and CD 2-dose cohorts. IRs and VE stratified by condition and age are presented in Figure. Adjusted VE for IBD patients who received 1 RZV dose was 63.4% (95%CIs: 24.9-82.2). Conclusion Our analysis provides real-world evidence that RZV vaccination is effective in preventing HZ in IBD patients ≥50 YOA and reduce the burden in this population with increased risk of HZ. These findings are consistent with the available literature on RZV effectiveness in patients with IBD, suggesting that this population could greatly benefit from RZV vaccination. 1. Yun H et al, Arthritis Rheumatol 2016;68:2328-37 Funding GSK

Identification of four latent classes of acute respiratory distress syndrome using PaO2/FIO2 ratio: an observational cohort study

Biological phenotypes in patients with the acute respiratory distress syndrome (ARDS) have previously been described. We hypothesized that the trajectory of PaO2/FIO2 ratio could be used to identify phenotypes of ARDS. We used a retrospective cohort analysis of an ARDS database to identify latent classes in the trajectory of PaO2/FIO2 ratio over time. We included all adult patients admitted to an intensive care unit who met the Berlin criteria for ARDS over a 4-year period in tertiary adult intensive care units in Manitoba, Canada. Baseline demographics were collected along with the daily PaO2/FIO2 ratio collected on admission and on days 1–7, 14 and 28. We used joint growth mixture modeling to test whether ARDS patients exhibit distinct phenotypes with respect to both longitudinal PaO2/FIO2 ratio and survival. The resulting latent classes were compared on several demographic variables. In our study group of 209 patients, we found that four latent trajectory classes of PaO2/FIO2 ratio was optimal. These four classes differed in their baseline PaO2/FIO2 ratio and their trajectory of improvement during the 28 days of the study. Despite similar baseline characteristics the hazard for death for the classes differed over time. This difference was largely driven by withdrawal of life sustaining therapy in one of the classes. Latent classes were identified in the trajectory of the PaO2/FIO2 ratio over time, suggesting the presence of different ARDS phenotypes. Future studies should confirm the existence of this finding and determine the cause of mortality differences between classes.

Group-Based Trajectory Modeling to Identify Patterns of Antipsychotic-Associated Weight Gain Among Children and Adolescents.

Antipsychotic-associated weight gain (AAWG) is a common adverse effect of second-generation antipsychotic (SGA) medications among children and adolescents. This study applied group-based trajectory modeling to identify latent trajectories of AAWG among children and adolescents and associated risk factors. This was a retrospective analysis of the IQVIA Ambulatory EMR-US database from 2016 to 2021. The cohort consisted of patients aged 6 to 19 years who were SGA naive and received at least 90 days of continuous SGA prescriptions. Group-based trajectory modeling was used to identify latent trajectories of AAWG development during a 24-month period since SGA initiation, and multinomial logistic regression analysis was conducted to examine the risk factors associated with the identified AAWG trajectories. A total of 16,262 patients were included. Group-based trajectory modeling identified the following 4 distinctive AAWG trajectories: persistent severe weight gain (4.2%), persistent moderate weight gain (20.1%), minor weight change (69.6%), and gradual weight loss (6.1%). Compared with the minor weight change group, younger age (12-17 vs 5-11: odds ratio [OR], 0.634; 95% confidence interval [CI], 0.521-0.771), lower baseline body mass index z -score (OR, 0.216; 95% CI, 0.198-0.236), and receiving olanzapine as the initial SGA (olanzapine vs aripiprazole: OR, 1.686; 95% CI, 1.673-1.699) were more likely to follow severe weight gain trajectories. The area under the receiver operating characteristic curves for comparing severe weight gain versus minor weight change groups and moderate weight vs minor weight change groups in the multinomial regression model were 0.91 and 0.8, respectively. A quarter of pediatric SGA recipients experienced persistent weight gain during the SGA treatment. The risk of having persistent AAWG can be predicted using patient characteristics collected before SGA initiation and the initial SGA agent.

Surgeon Experience Is the Most Important Predictor of Case Failure Rate for Anterior Odontoid Screw Fixation: A Large Database Study.

Retrospective database analysis. Determine risk factors and failure rate of anterior odontoid screw fixation surgery. Anterior odontoid screw fixation (AOSF) stabilizes type II dens fractures while preserving cervical motion. Despite having potential advantages, AOSF's failure rate and factors contributing to failure remain unknown. We identified AOSF patients in the national claims database Pearldiver using CPT code 22318. Failure was defined as the requirement of supplementary posterior fusion surgery in the C1-C2 or occiput-C2 region after the AOSF. We considered potential predictors of failure including age, sex, Charlson Comorbidity Index (CCI), surgeon experience, history of osteoporosis, obesity, and tobacco use. Univariate comparison analysis and logistic regression were conducted to identify factors associated with the need for additional posterior surgery. For 2008 identified cases of AOSF, 249 cases (12.4%) required additional posterior fusion. Seventy-one of the 249 cases (28.5%) underwent revision surgery on the same day as the AOSF. Over 86% of revisions (215 cases) occurred within 200 days of the initial procedure. Posterior fusion rates are inversely correlated with surgeon experience, with the most experienced surgeons having a rate of 10.0%, followed by 11.5% for moderately experienced surgeons, and 15.0% for the least experienced surgeons. When comparing moderate and inexperienced surgeons to experienced surgeons, the odds ratios for posterior fusion were 1.18 ( P >0.05) and 1.61 ( P <0.006), respectively. Logistic regression revealed that both lesser experience (odds ratio=1.50) and osteoporosis (odds ratio=1.44) were the only factors significantly associated with failure ( P <0.05). Our findings indicate a correlation between AOSF success and surgeon experience. While currently published results suggest higher success rates, most of this data originates from experienced surgeons and specialized centers, therefore, they may not accurately reflect the failure rate encountered in a more general practice setting. Level III.

Retrospective database analysis for clinical diagnoses commonly associated with pneumococcal diseases in the Malaysian healthcare system over a 3-year period (2013–2015)

BackgroundPneumococcal disease caused by Streptococcus pneumoniae is an important cause of morbidity and mortality across all ages, particularly in younger children and older adults. Here, we describe pneumococcal disease hospitalizations at Ministry of Health (MoH) facilities in Malaysia between 2013 and 2015.MethodsThis was a retrospective databases analysis. Tabular data from the Malaysian Health Data Warehouse (MyHDW) were used to identify microbiologically confirmed, pneumococcal disease hospitalizations and deaths during hospitalization, using hospital-assigned ICD-10 codes (i.e., classified as meningitis, pneumonia, or non-meningitis non-pneumonia). Case counts, mortality counts, and case fatality rates were reported by patient age group and by Malaysian geographic region.ResultsA total of 683 pneumococcal disease hospitalizations were identified from the analysis: 53 pneumococcal meningitis hospitalizations (5 deaths and 48 discharges), 413 pneumococcal pneumonia hospitalizations (24 deaths and 389 discharges), and 205 non-meningitis non-pneumonia pneumococcal disease hospitalizations (58 deaths and 147 discharges). Most hospitalizations occurred in children aged < 2 years. Crude mortality was highest among children aged < 2 years (for all three disease categories), among adults aged ≥ 65 years (for pneumococcal pneumonia), or among adults aged 65–85 years (for non-meningitis non-pneumonia pneumococcal disease). The case fatality rate, all ages included, was 5.8% for pneumococcal pneumonia, 9.1% for pneumococcal meningitis, and 28.3% for non-meningitis non-pneumonia pneumococcal disease.ConclusionsOur study is the first to document pneumococcal disease hospitalizations and deaths during hospitalization in Malaysia. Although this database analysis likely underestimated case counts, and the true disease burden could be even greater, the study demonstrates a substantial burden of pneumococcal disease. Public health measures, including vaccination, would significantly contribute to the prevention of hospitalizations and deaths associated with pneumococcal disease in Malaysia.

Supplementary value and diagnostic performance of computed tomography scout view in the detection of thoracolumbar spine injuries.

Assessing the diagnostic performance and supplementary value of whole-body computed tomography scout view (SV) images in the detection of thoracolumbar spine injuries in early resuscitation phase and identifying frequent image quality confounders. In this retrospective database analysis at a tertiary emergency center, three blinded senior experts independently assessed SV to detect thoracolumbar spine injuries. The findings were categorized according to the AO Spine classification system. Confounders impacting SV image quality were identified. The suspected injury level and severity, along with the confidence level, were indicated. Diagnostic performance was estimated using the caret package in R programming language. We assessed images of 199patients, encompassing 1592 vertebrae (T10-L5), and identified 56 spinal injuries (3.5%). Among the 199 cases, 39 (19.6%) exhibited at least one injury in the thoracolumbar spine, with 12 (6.0%) of them displaying multiple spinal injuries. The pooled sensitivity, specificity, and accuracy were 47%, 99%, and 97%, respectively. All experts correctly identified the most severe injury of AO type C. The most common image confounders were medical equipment (44.6%), hand position (37.6%), and bowel gas (37.5%). SV examination holds potential as a valuable supplementary tool for thoracolumbar spinal injury detection when CT reconstructions are not yet available. Our data show high specificity and accuracy but moderate sensitivity. While not sufficient for standalone screening, reviewing SV images expedites spinal screening in mass casualty incidents. Addressing modifiable factors like medical equipment or hand positioning can enhance SV image quality and assessment.

Deoxycholic Acid for Submental Convexity: A MAUDE Database Analysis

Study Design The study was a retrospective cross-sectional database analysis. Objective Deoxycholic acid (DOC) injections are a novel, in-office procedural alternative to submental liposuction or submentoplasty to address excess submental fat. Post-market safety data regarding this treatment is currently limited. The objective of this study is to analyze adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database. Methods The MAUDE database was queried for all reports related to adverse events involving deoxycholic acid using the search terms “KYBELLA” and “deoxycholic acid.” Reports were individually reviewed by 2 reviewers and categorized with special attention to adverse events. Results A total of 34 medical device reports were identified from the database query. Thirteen of these reports (21 total events) were included in the analysis after excluding duplicates, unrelated adverse events, or events associated with the off-label use of DOC. Reported adverse events include excessive swelling (n = 5, 24%), marginal mandibular nerve weakness (n = 4, 19%), unsatisfactory aesthetic outcome (n = 4, 19%), numbness (n = 3, 14%), dysphagia (n = 1, 5%), infection (n = 1, 5%), and skin necrosis (n = 3, 14%). Two patients required hospitalization for skin necrosis management; both had underlying systemic diseases. Conclusions Adverse events following DOC injections included excessive swelling, dysphagia, numbness, infection, unsatisfactory aesthetic outcome, facial nerve weakness, and skin necrosis requiring hospitalization and/or surgery. Patient counseling regarding these adverse events should be discussed when offering DOC injections for submental convexity.