Search

BackgroundTo determine the clinical importance of pneumatosis intestinalis (PI) on surgical decision-making and patient outcomes.MethodsA matched cohort observational study was conducted including all clinical encounters for both ambulatory and inpatient care at UCLA Health between February 15, 2006 and January 31, 2023. Patients were initially identified using encounter diagnostic codes for "other specified diseases of intestine." A radiologic diagnosis of PI was then assessed using natural language processing techniques followed by confirmation using manual chart review. Patients who did not have PI served as a control group. Patient comorbidity was assessed using Elixhauser comorbidity scores. Logistic regression and Cox hazard analyses were used to assess associations between PI and mortality. The main outcome was 90-day all-cause mortality. Secondary outcomes were the proportion of patients undergoing surgery and, of those, how many required bowel resections.ResultsOf the 16,728 patients identified by diagnostic coding, 315 were confirmed to have a diagnosis of PI. The 90-day mortality rate for all patients with PI was 29%. Surgery was performed for 62 patients (20%), of whom 46 (72%) underwent bowel resection and 16 (28%) underwent abdominal exploration alone. Most patients underwent surgery for peritonitis (37%), bowel obstruction (31%), and/or pneumoperitoneum (23%) in association with PI; whereas only 8% of patients received surgery exclusively for PI. There was no statistically significant association between PI and mortality with logistic regression conditioned on other risk factors for mortality. In contrast, survival analysis of a matched cohort demonstrated a small effect of PI on mortality (hazard ratio = 1.24: 95% confidence interval = 1.16-1.32, P = 0.021).ConclusionsMost patients with a diagnosis of PI survive without requiring surgery. Of those who undergo surgery, nearly all have indications for laparotomy exclusive of PI. Mortality in patients who have pneumatosis is strongly associated with comorbid disease, with little to no independent association with PI. Our findings suggest that the presence of PI should not be a primary indication for surgical intervention.

BACKGROUND: Previous studies found that documentation of comorbidities differed when Veterans received care within versus outside Veterans Health Administration (VHA). Changes to medical center funding, increased attention to performance reporting, and expansion of Clinical Documentation Improvement programs, however, may have caused coding in VHA to change. METHODS: Using repeated cross-sectional data, we compared Elixhauser-van Walraven scores and Medicare Severity Diagnosis Related Group (DRG) severity levels for Veterans admissions across settings and payers over time, utilizing a linkage of VHA and all-payer discharge data for 2012-2017 in seven US states. To minimize selection bias, we analyzed records for Veterans admitted to both VHA and non-VHA hospitals in the same year. Using generalized linear models, we adjusted for patient and hospital characteristics. RESULTS: Following adjustment, VHA admissions consistently had the lowest predicted mean comorbidity scores (4.44 (95% CI 4.34-4.55)) and lowest probability of using the most severe DRG (22.1% (95% CI 21.4%-22.8%)). In contrast, Medicare-covered admissions had the highest predicted mean comorbidity score (5.71 (95% CI 5.56-5.85)) and highest probability of using the top DRG (35.3% (95% CI 34.2%-36.4%)). CONCLUSIONS: More effective strategies may be needed to improve VHA documentation, and current risk-adjusted comparisons should account for differences in coding intensity.

INTRODUCTION: First pass effect (FPE), achievement of complete recanalization (mTICI 2c/3) with a single pass, is a significant predictor of favorable outcomes for endovascular treatment (EVT) in large vessel occlusion stroke (LVO). However, data concerning the impact on functional outcomes and predictors of FPE in medium vessel occlusions (MeVO) are scarce. PATIENTS AND METHODS: We conducted an international retrospective study on MeVO cases. Multivariable logistic modeling was used to establish independent predictors of FPE. Clinical and safety outcomes were compared between the two study groups (FPE vs non-FPE) using logistic regression models. Good outcome was defined as modified Rankin Scale 0-2 at 3 months. RESULTS: Eight hundred thirty-six patients with a final mTICI ⩾ 2b were included in this analysis. FPE was observed in 302 patients (36.1%). In multivariable analysis, hypertension (aOR 1.55, 95% CI 1.10-2.20) and lower baseline NIHSS score (aOR 0.95, 95% CI 0.93-0.97) were independently associated with an FPE. Good outcomes were more common in the FPE versus non-FPE group (72.8% vs 52.8%), and FPE was independently associated with favorable outcome (aOR 2.20, 95% CI 1.59-3.05). 90-day mortality and intracranial hemorrhage (ICH) were significantly lower in the FPE group, 0.43 (95% CI, 0.25-0.72) and 0.55 (95% CI, 0.39-0.77), respectively. CONCLUSION: Over 2/3 of patients with MeVOs and FPE in our cohort had a favorable outcome at 90 days. FPE is independently associated with favorable outcomes, it may reduce the risk of any intracranial hemorrhage, and 3-month mortality.

Objective: To assess the real‐world effectiveness of ubrogepant by evaluating self‐reported satisfaction with pain relief, ability to think clearly, and return to normal function in individuals who had used ubrogepant to treat a migraine episode within the preceding 14 days. Background: Ubrogepant is an oral calcitonin gene–related peptide receptor antagonist approved for the acute treatment of migraine in adults. Few studies have evaluated the real‐world effectiveness of ubrogepant. Methods: The UNIVERSE study was an observational, cross‐sectional survey conducted between February 2021 and April 2021 in US adult Migraine Buddy application (app) users currently treated with ubrogepant. Individuals who were 18 years of age or older and reported at least one dose of ubrogepant in the previous 14 days completed a 30‐question survey in the app. The survey assessed respondent demographics, migraine history, acute treatment patterns, and treatment satisfaction with ubrogepant. Respondents also reported prior acute medication use and reasons for switching to ubrogepant. Results: Of the 1303 ubrogepant users contacted, 302 (23.2%; 50 mg, 120 participants; 100 mg, 182 participants) were included in this study. The mean (standard deviation) age was 41.9 (11.2) years, and 90.1% (272/302) were female. Satisfaction with migraine relief at 2, 4, and 24 h post‐dose was reported by 75.8% (229/302), 83.4% (252/302), and 78.5% (237/302) of participants, respectively. Satisfaction with the ability to think clearly after taking ubrogepant was reported by 85.1% (257/302) of participants, and 83.8% (253/302) were satisfied with their ability to return to normal function. Furthermore, 90.7% (274/302) of participants reported that they were likely to continue using ubrogepant to treat their migraine. Most participants (n = 264 [87%]) reported switching to ubrogepant due to inadequate treatment response with their previous treatment. In this subgroup, comparable outcomes were observed with respect to satisfaction with migraine relief, ability to think clearly, and return to normal function. Conclusions: Ubrogepant demonstrated real‐world effectiveness in the acute treatment of migraine, as evidenced by high levels of treatment satisfaction and a strong indication of their intent to continue using the medication. Plain Language Summary: Ubrogepant is approved for the acute treatment of migraine in adults. In this study, adults who had used ubrogepant to treat a migraine attack in the previous 14 days responded to survey questions regarding their satisfaction with pain relief, ability to think clearly, and return to normal function. Results indicated that the majority of participants experienced high levels of satisfaction with ubrogepant because most of them said that these areas of their life improved after treatment. [ABSTRACT FROM AUTHOR]

Previous assessments suggest that surgical results of paraesophageal hernia (PEH) repair were negatively impacted by increasing levels of obesity. A better understanding of the association of obesity on outcomes of PEH repair will support surgeons making evidence-based decisions on the surgical candidacy of individual patients. This single institution retrospective cohort study included 884 consecutive patients with giant PEH undergoing surgical repair between 1 January 2000 and 30 June 2020. Preoperative body mass index (BMI) was documented at the time of surgery. Main outcomes included perioperative blood loss, length of hospital stay, major complications, early hernia recurrence, and mortality. The mean (standard deviation [SD]) age at surgery was 68.4 (11.1), and 645 (73.0%) were women. Among the 884 patients, 875 had a documented immediate preoperative BMI and were included in the analysis. Mean (SD) BMI was 29.24 (4.91) kg/m2. Increasing BMI was not associated with increased perioperative blood loss (coefficient, 0.01; 95% confidence interval [CI], −0.01 to 0.02), prolonged length of stay (coefficient, −0.01; 95% CI, −0.02 to 0.01), increased incidence of recurrent hernia (odds ratio [OR], 1.03; 95% CI, 0.95–1.10), or increased major complications (OR, 0.93; 95% CI, 0.82–1.05). The 90-day mortality rate was 0.3%. Furthermore, when compared with the normal weight group, overweight and all levels of obesity were not related to unfavorable outcomes. No association was found between BMI and perioperative outcomes or short-term recurrence in patients undergoing PEH repair. Although preoperative weight loss is advisable, a higher BMI should not preclude or delay surgical management of giant PEH. [ABSTRACT FROM AUTHOR]

There is an abundance of outcomes research for clinical hypnosis showing promising results. Nonetheless, hypnosis is still underutilized in clinical care. For a behavioral intervention to enter mainstream clinical care, efficacy needs to be demonstrated with exceptionally high quality of evidence, and its reporting needs to be complete and sufficiently clear to enable replication and clinical use. The present article provides best practice guidelines formulated by the Task Force for Establishing Efficacy Standards for Clinical Hypnosis for conducting and reporting clinical hypnosis research.The recommendations are presented in two tiers. Tier I recommendations include essential best practices, such as a call for the use of detailed research and intervention manuals, plans for and reporting of participant-education about hypnosis, the use of hypnotizability scales with good psychometric properties, and clear reporting of the hypnotizability measurement. Tier I also includes the sharing of intervention manuals, the reporting of the induction procedure, the labeling of the intervention for participants, and the definition of hypnosis used. Tier II includes preferred recommendations, calling for measurement of adherence to home practice, measurement of hypnotizability using scales with both subjective and behavioral measures of responsiveness, and the involvement of participants from the full hypnotizability spectrum. Tier II also includes the assessment of variables related to proposed mechanisms of action, the reporting of participants prior hypnosis experiences, and the relationship of expectancies and treatment outcomes.This list of recommendations will be useful for researchers, reviewers, and journal editors alike when conducting, reporting, or evaluating studies involving clinical hypnosis. [ABSTRACT FROM AUTHOR]

Background There is emerging evidence to suggest the role of induction chemotherapy (IC) in definitive management of locoregionally advanced sinonasal squamous cell carcinoma (SNSCC). We evaluated the influence of IC on survival and predictors of its use in SNSCC patients. Methods The 2004 to 2017 National Cancer Database was queried for patients with locoregionally advanced SNSCC (T4/M0). Treatments were stratified into seven groups: definitive chemoradiation (CRT), IC with definitive CRT (IC + CRT), IC + CRT with salvage surgery (IC + CRT + Sx), definitive surgery (Sx), IC with definitive surgery (IC + Sx), definitive surgery with adjuvant radiation or CRT (Sx + ATx), or IC + Sx + ATx. Cox proportional-hazards regression assessed overall survival (OS) and logistic regression identified predictors of IC. Results Of 3,162 patients, 1,088 (34.4%) were female with a mean age of 63.4 ± 13.4 years. The 2- and 5-year OS rates were 58.6 and 42.0%, respectively. Compared with CRT, Sx + ATx (hazard ratio [HR]: 0.663; p < 0.001), IC + Sx (HR: 0.606; p = 0.005), or IC + Sx + ATx (HR: 0.468; p = 0.001) exhibited reduced mortality. Among patients who were treated with definitive surgery, those receiving IC had additional OS benefit (all p s < 0.05). Older age (odds ratio [OR]: 0.607; p < 0.001), female sex (OR: 0.759; p = 0.028), Black race (OR: 1.650; p < 0.001, T4b stage (OR: 1.674; p < 0.001), and higher N stage (OR: 1.395; p < 0.001) were predictors of IC. Conclusion IC prior to definitive surgery with or without adjuvant therapy exhibited the highest OS for locoregionally advanced SNSCC. Age, sex, race, and T/N staging were predictors of IC. Multimodal treatment regimens involving surgery as the primary modality may, therefore, provide the greatest therapeutic response. [ABSTRACT FROM AUTHOR]

Background The University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center has developed a novel data resource, the Cancer Information and Population Health Resource (CIPHR), for conducting catchment area evaluation and cancer population health research that links the North Carolina Central Cancer Registry (NCCCR) to medical and pharmacy claims data from Medicare, Medicaid, and private plans operating within North Carolina. This study's aim was to describe the CIPHR data and provide examples of potential cohorts available in those data. Methods We present the underlying populations included in the NCCCR and claims data before linkage and demonstrate estimated sample sizes when these data are linked and commonly used insurance enrollment criteria are applied. Results Data for the years 2003-2020 are present in CIPHR and include 947 977 cancer cases from the NCCCR and 21.6 million enrollees in public and private health insurance (cancer and noncancer cases). When limited to first or only cancers (n = 672 377), 86% could be linked to insurance enrollment for at least 1 month during 2003-2020 (n = 582 638), with 62% of individuals linking to enrollment during the month of cancer diagnosis. Among all registry cancer cases, 47% (n = 317 898) had continuous insurance enrollment for at least 12 months before and after cancer diagnosis. Conclusion CIPHR illustrates the utility of establishing and maintaining a statewide, comprehensive cancer population health database. This resource serves to characterize the cancer center catchment area and aids in tracking cancer outcomes and trends in care delivery as well as identifying disparities that require intervention and policy focus. [ABSTRACT FROM AUTHOR]

This paper is derived from a presentation given by the first author at the 2024 Symposium for the Calvin Schwabe Award, presented to Dr. Jan Sargeant for Lifetime Achievement in Veterinary Epidemiology and Preventive Medicine. Researchers must work toward ensuring validity throughout the research process, but we also should ensure that our resulting outcomes are specified to appropriately inform and enable decision-making by the end-users. Given the scope and diversity of topics addressed by veterinary researchers, the potential beneficiaries or stakeholders of our research also varies. Stakeholders or endusers may include veterinary practitioners, other researchers, livestock owners, "pet parents," government officials, corporate entities, or the general public in the case of public health or food security and safety issues. Current research in animal agriculture provides an opportunity to consider research outcomes in a sustainability framework which concurrently values social, economic, and environment impacts of animal health and management decisions. In companion animals, contemporary issues of affordability and access to care, quality of life, or compliance effects on efficacy, also extend the spectrum of relevant research outcomes. In these cases, traditional measures of animal health, such as morbidity, mortality, or weight gain, may not be the most relevant for the end-users. Furthermore, if studies are not designed and analyzed with well-defined primary outcomes that are informed by stakeholders' values, but rather post-hoc considerations of these values are made based on indirect or surrogate measures, there is the potential to incorporate error and bias into our conclusions and the end-users' decision-making processes. [ABSTRACT FROM AUTHOR]

Opioids are commonly used to provide analgesia during and after congenital heart surgery. The effects of exposure to opioids on neurodevelopment in neonates and infants are not well understood. This study sought to evaluate the associations between cumulative opioid exposure (measured in morphine mg equivalent) over the first year of life and 2-year neurodevelopmental outcomes (Bayley Scales of Infant and Toddler Development-Third/Fourth Edition [Bayley-III/IV] cognitive, language, and motor scores). A single-center retrospective cohort study of infants undergoing congenital heart surgery was performed. Adjustment for measurable confounders was performed through multivariable linear regression. A total of 526 subjects were studied, of whom 32% underwent Society for Thoracic Surgeons-European Association for Cardio-Thoracic Surgery category 4 or 5 operations. In unadjusted analyses, higher total exposure to opioids was associated with worse scores across all 3 Bayley-III/IV domain scores (all P < 0.05). After adjustment for measured confounders, greater opioid exposure was associated with lower Bayley-III/IV scores (cognitive: β = −1.0 per log-transformed morphine mg equivalents, P = 0.04; language: β = −1.2, P = 0.04; and motor: β = −1.1, P = 0.02). Total hospital length of stay, prematurity, genetic syndromes, and worse neighborhood socioeconomic status (represented either by Social Vulnerability Index or Childhood Opportunity Index) were all associated with worse Bayley-III/IV scores across all domains (all P < 0.05). Greater postnatal exposure to opioids was associated with worse neurodevelopmental outcomes across cognitive, language, and motor domains, independent of other less modifiable factors. This finding should motivate research and efforts to explore reduction in opioid exposure while preserving quality cardiac intensive care. [ABSTRACT FROM AUTHOR]

This article explores the significance of outcomes research in measuring the effectiveness of medical treatments and interventions for better patient outcomes and healthcare delivery. It discusses the different types of outcomes research and how it supports fairness, evidence-based healthcare, and personalized medicine. The article also addresses the current trends and challenges in outcomes research, including the evaluation of treatment outcomes in vulnerable patient groups and addressing socioeconomic and cultural differences. It emphasizes the importance of patient-centered research initiatives and adaptable policy development in addressing healthcare inequalities and public health emergencies. Additionally, the article discusses the challenges in developing pharmaceutical policies and the need for ethical principles and transparency in clinical outcomes research, particularly in low- and middle-income countries. It introduces Frontiers in Pharmacology - Drugs Outcomes Research and Policies as a platform for sharing research and policies with the scientific community. The author acknowledges the assistance of Colin Pillai in preparing the manuscript and declares no financial conflicts of interest. [Extracted from the article]

BACKGROUND: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. METHODS: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke--defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument--a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score--based comparison using overlap weighting as a secondary analysis. RESULTS: The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73--1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70--0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). CONCLUSIONS: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR. GRAPHIC ABSTRACT: A graphic abstract is available for this article. [ABSTRACT FROM AUTHOR]

Objective: To assess perioperative and readmission outcomes of patients undergoing head and neck cancer (HNCA) surgery at safety‐net hospitals (SNHs) in a modern cohort. Study Design: Retrospective cohort study. Setting: Nationwide Readmissions Database (NRD), 2010 to 2019. Methods: All elective adult (≥18 years) admissions involving HNCA resection were identified from the NRD. To calculate safety‐net burden, the proportion of Medicaid or uninsured patients admitted to each hospital for any indication was tabulated annually, with centers in the highest quartile defined as SNHs. To perform risk adjustment in assessing perioperative and readmission outcomes, multivariable regression models were developed. Results: Of an estimated 133,018 head and neck surgical patients, 26.5% (n = 35,268) received treatment at a SNH. Utilization of SNHs increased over the decade‐long study period, with 29.8% of individuals treated at these sites in 2019. After multivariable adjustment, several patient factors were noted to be associated with SNHs, including younger age, lower comorbidity burden, and income within the lowest quartile. Although incidence of adverse events decreased at both SNHs and non‐SNHs during the study period, treatment at SNHs remained associated with these events after risk adjustment (adjusted odds ratio: 1.17, 95% confidence interval: 1.08‐1.28, P <.001). Conclusion: SNHs continue to provide valuable specialty care to underserved populations, often with limited financial resources. Despite promising results from prior decades demonstrating comparable perioperative outcomes, the present study noted increased adverse events following HNCA surgery at these sites. Such findings underscore the need for continued advocacy to secure necessary funding for these centers. [ABSTRACT FROM AUTHOR]

Abstract Purpose: Estrogen receptor-positive (ER+), progesterone receptor-negative (PR-) and human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) often developed resistance to endocrine treatment (ET). We aimed to explore (1) the different clinicopathological features between ER+/PR+/HER2- and ER+/PR-/HER2- BC, and (2) whether ER+/PR-/HER2- early BC patients could benefit from adjuvant ET. Methods: All patients treated for ER+/HER2- early BC who underwent surgery between 2010 and 2021 from a BC database in China were retrospectively examined. The cases followed up for less than six months were excluded. Results: The records of ER+/PR+/HER2- (n = 10843) and ER+/PR-/HER2- BC (n = 1193) cases were reviewed, with median follow-up times of 35.8 and 47.0 months, respectively. Compared with ER+/PR+/HER2- cases, ER+/PR-/HER2- BC occurred more in postmenopausal women (73.1% vs. 52.9%, p = 0.000) and were more likely to be T > 2 cm (40.6% vs. 37.6%, p = 0.048) and Ki67 > 20%+ (48.1% vs. 36.9%, p = 0.000). However, ER+/PR-/HER2- cases had fewer nodal involvement (32.9% vs. 36.9%, p = 0.000). Approximately 82.2% (981/1193) of ER+/PR-/HER2- patients received ET, while approximately 17.8% (212/1193) did not. Compared to patients did not receive adjuvant ET, the ET group had similar disease-free survival (DFS) (HR = 1.33, 95% confidence interval (CI): 0.68–2.59, p = 0.444) and overall survival (OS) (HR = 1.17, 95%CI: 0.37–3.68, p = 0.799). 65.7% of recurrent ER+/PR-/HER2- patients experienced distant relapse (65.7% vs. 48.2% (for ER+/PR + cases), p = 0.011). By comparison, recurrent ER+/PR+/HER2- patients were more likely to experience only local relapse (31.6% vs. 14.9% (for ER+/PR- cases), p = 0.007). Conclusions: ER+/PR-/HER2- BC was a special subtype with aggressive clinicopathological features and more tend to have distant metastasis rather than nodal involvement or local relapse. ER+/PR-/HER2- early BC did not seem to benefit from adjuvant ET.

Abstract Background The potential association of long‐term oral corticosteroid (OCS) use with adverse events (AEs) in patients with bullous pemphigoid (BP) is not well characterized in a real‐world setting. Objectives To evaluate the effect of OCS use and treatment duration on the incident AEs in patients with BP. Methods This retrospective cohort study used medical and pharmacy claims and patient enrollment data from IQVIA PharMetrics® Plus from 2006−2021. Eligible patients had a diagnosis of BP between 1 January 2006 and 30 June 2020 (≥2 claims for BP ≥ 30 days apart). Patients in the OCS cohort also had a claim for OCS use, ≥7.5 mg daily dose of prednisone or equivalent, and no claims for a nonoral systemic corticosteroid (CS) at any time during the study period. A control cohort of patients with BP not using OCS was also selected. Relative risk ratios were estimated between the incidence of AEs in OCS users with different exposure durations (short‐term, 90 days) and nonusers by Poisson regression, after adjusting for age, sex, prior drug use, and baseline Charlson Comorbidity Index score within the follow‐up period. Results At the 1‐year follow‐up, long‐term OCS users had a higher incidence of infections, cataract, osteoporosis, heart failure, depression or anxiety, and diabetes compared with OCS nonusers (p

Background: Optimal anesthetic strategy for the endovascular treatment of stroke is still under debate. Despite scarce data concerning anesthetic management for medium and distal vessel occlusions (MeVOs) some centers empirically support a general anesthesia (GA) strategy in these patients. Methods: We conducted an international retrospective study of MeVO cases. A propensity score matching algorithm was used to mitigate potential differences across patients undergoing GA and conscious sedation (CS). Comparisons in clinical and safety outcomes were performed between the two study groups GA and CS. The favourable outcome was defined as a modified Rankin Scale (mRS) 0–2 at 90 days. Safety outcomes were 90-days mortality and symptomatic intracranial hemorrhage (sICH). Predictors of a favourable outcome and sICH were evaluated with backward logistic regression. Results: After propensity score matching 668 patients were included in the CS and 264 patients in the GA group. In the matched cohort, either strategy CS or GA resulted in similar rates of good functional outcomes (50.1% vs. 48.4%), and successful recanalization (89.4% vs. 90.2%). The GA group had higher rates of 90-day mortality (22.6% vs. 16.5%, p < 0.041) and sICH (4.2% vs. 0.9%, p = 0.001) compared to the CS group. Backward logistic regression did not identify GA vs CS as a predictor of good functional outcome (OR for GA vs CS = 0.95 (0.67–1.35)), but GA remained a significant predictor of sICH (OR = 5.32, 95% CI 1.92–14.72). Conclusion: Anaesthetic strategy in MeVOs does not influence favorable outcomes or final successful recanalization rates, however, GA may be associated with an increased risk of sICH and mortality. [ABSTRACT FROM AUTHOR]

Balance is an important component of daily function and impairments can lead to injury and quality-of-life limitations. Balance is not well studied in the burn population. This study examines the frequency of long-term balance impairments and associated factors after a burn injury. The Burn Model System National Database was analyzed. Trouble with balance was self-reported at discharge, 6, 12, 24, and 60 months after injury. Regression analyses examined the associations between demographic and clinical characteristics and balance impairments at 12 months. Of 572 participants, balance impairments were most reported at discharge (40.3%), continuing over 60 months (26.8–36.0%). Those reporting balance impairments (n = 153) were more likely to be older, unemployed, have Medicaid or Medicare, receive inpatient rehabilitation, receive outpatient physical or occupational therapy, have vision problems, have leg or feet burns and swelling, and have foot numbness compared to those without (p ≤ 0.001). Regression analysis demonstrated a 4% increased odds of balance impairment for every increase in year of age (p < 0.001), 71% lower odds if employed at time of injury (p < 0.001), and 140% higher odds if receiving outpatient physical or occupational therapy at 12 months (p = 0.008). Common reports of balance impairments highlight the need for routine screenings to identify burn survivors that may benefit from targeted interventions.

Cost-effectiveness analyses are required for therapies within Canada’s universal healthcare system, leading to delays relative to U.S. healthcare. Patients with Hodgkin lymphoma (HL) generally have an excellent prognosis, but those who relapse after or are ineligible for transplant benefit from novel therapies, including brentuximab vedotin (BV). BV was FDA-approved in 2011 but not Canadian-funded until 2014. To assess the impact of access delays, we compared changes in survival for U.S. (by insurer) and Canadian patients in periods pre/post-U.S. approval. Patients were 16–64 years, diagnosed with HL in 2007–2010 (Period 1) and 2011–2014 (Period 2) from the U.S. SEER and Canadian Cancer Registries. Approval date (surrogate) was utilized as therapy was unavailable in registries. Kaplan-Meier survival curves and adjusted Cox regression models compared survival between periods by insurance category. Among 12,003 U.S. and 4210 Canadian patients, survival was better in U.S. patients (adjusted hazard ratio (aHR) 0.87 (95%CI 0.77–0.98)) between periods; improvement in Canadian patients (aHR 0.84 (95%CI 0.69–1.03) was similar but non-significant. Comparisons between insurers showed survival was significantly worse for U.S. uninsured and Medicaid vs. U.S. privately insured and Canadian patients. Given the increasingly complex nature of oncologic funding, this merits further investigation to ensure equity in access to therapy developments.

Background: Poison centers develop triage threshold guidelines for pediatric metformin ingestions. Our network uses 1700 mg, or 85 mg/kg. Objective: To describe the dose, clinical course, and outcomes for inadvertent metformin ingestions in children 5 years old and younger reported to our statewide poison center network. Methods: We searched the poison center database 2011 to 2021 for metformin ingestions in patients 5 years and younger. Variables included age, sex, weight, dose, symptoms, outcome, and more. We used descriptive statistics with medians and interquartile ranges (IQR) for continuous variables. Results: Of 669 cases, exposures by age were 208 (31.1%) 1 to 2 years, and 275 (41.1%) 2 years. Weight was recorded in 342 (51.1%) (median 13.5 kg; IQR: 3.7 kg), and dose in 149 (22.3%) (median 500 mg; IQR: 500 mg). Milligram/kilogram values were available for 103 (15.4%) with median 42.4 mg/kg, IQR: 39 mg/kg. Most (647, 98.5%) exposures were unintentional. Most (445/669, 66.5%) were managed at a non-healthcare facility, while 204 (30.7%) were already at or referred to a healthcare facility. Of these 204 patients, 169 (82.8%) were evaluated and treated at the emergency department and discharged. Four (2%) were admitted to critical care, and 7 (3.4%) to the ward. Medical outcomes by effect were 5 (0.7%) minor, 2 (0.3%) moderate, 253 (37.8%) none, 292 (43.6%) not followed (minimal effects possible), and no major effects or deaths. Of 20 clinical occurrences reported, vomiting was most common (8, 1.2%). Conclusion: Despite little recorded dosage information, pediatric metformin ingestions under 85 mg/kg had predominantly uneventful medical outcomes. [ABSTRACT FROM AUTHOR]

Background: Neoadjuvant therapy improves survival benefits in patients with locally advanced non-small cell lung cancer but increases tissue density, presenting challenges for surgeons. Objectives: To compare the differences in surgical complexity and short-term prognostic outcomes between neoadjuvant targeted therapy (NTT) and neoadjuvant chemoimmunotherapy (NCI). Design/methods: This study enrolled 106 patients underwent curative surgery after neoadjuvant therapy between January 2020 and December 2023 at the National Cancer Center of China. Differences in surgical complexity and short-term prognostic outcomes between the two neoadjuvant therapy cohorts were evaluated. The pathological indicators such as pathological response rate and lymph node upstaging/downstaging were then analyzed. Results: In total, 33 patients underwent NTT and 73 underwent NCI preoperatively. Patients who received NTT showed a higher minimally invasive surgery rate (84.8% versus 53.4%, p < 0.01), shorter operative time (144 versus 184 min, p < 0.01), lower conversion rate (3.3% versus 17.8%, p = 0.03), less postoperative drainage (day 3: 140 versus 200 mL, p = 0.03), and lower incidence of postoperative complications including arrhythmias (6.1% versus 26%, p = 0.02). The pathological response rate in the NTT and NCI groups was 70% and 75%, respectively, with the latter group showing a higher complete pathological response rate. The two groups had no significant differences in major pathological response and lymph node pathological response rate. Conclusion: Patients who received NTT presented fewer surgical challenges for surgeons and had better surgical outcomes than those who received NCI therapy, with comparable pathological response rates between the two cohorts. Accordingly, NTT is the preferred induction regimen for patients harboring mutation status. [ABSTRACT FROM AUTHOR]

Cost-effectiveness analyses are required for therapies within Canada's universal healthcare system, leading to delays relative to U.S. healthcare. Patients with Hodgkin lymphoma (HL) generally have an excellent prognosis, but those who relapse after or are ineligible for transplant benefit from novel therapies, including brentuximab vedotin (BV). BV was FDA-approved in 2011 but not Canadian-funded until 2014. To assess the impact of access delays, we compared changes in survival for U.S. (by insurer) and Canadian patients in periods pre/post-U.S. approval. Patients were 16–64 years, diagnosed with HL in 2007–2010 (Period 1) and 2011–2014 (Period 2) from the U.S. SEER and Canadian Cancer Registries. Approval date (surrogate) was utilized as therapy was unavailable in registries. Kaplan-Meier survival curves and adjusted Cox regression models compared survival between periods by insurance category. Among 12,003 U.S. and 4210 Canadian patients, survival was better in U.S. patients (adjusted hazard ratio (aHR) 0.87 (95%CI 0.77–0.98)) between periods; improvement in Canadian patients (aHR 0.84 (95%CI 0.69–1.03) was similar but non-significant. Comparisons between insurers showed survival was significantly worse for U.S. uninsured and Medicaid vs. U.S. privately insured and Canadian patients. Given the increasingly complex nature of oncologic funding, this merits further investigation to ensure equity in access to therapy developments. [ABSTRACT FROM AUTHOR]

Delirium is prevalent in elderly patients, linked to elevated mortality rates, heightened healthcare resource use, and caregiver burden. Inflammatory bowel disease (IBD) poses various delirium risk factors, yet the impact on geriatric IBD patient outcomes remains unexplored. Using 2016–2019 National Inpatient Sample data, we identified ≥65-year-old patients admitted for IBD (Crohn's, ulcerative colitis) management stratified by delirium presence as a secondary diagnosis. The study aimed to assess delirium's impact on geriatric IBD patient outcomes. Among 67,534 elderly IBD admissions, 0.7% (470) developed delirium. The delirium group had a 4.8-fold increase in in-hospital mortality risk (odds ratio 4.80, P < 0.001, 95% confidence interval [CI] 1.94–11.8). IBD patients with delirium experienced prolonged length of stay (adjusted mean difference 5.15 days, 95% CI 3.24–7.06, P < 0.001) and increased care costs (adjusted mean difference $48,328, 95% CI $26,485–$70,171, P < 0.001) compared to those without delirium. Elderly IBD patients with delirium face higher mortality risk, prolonged hospitalization, and increased healthcare costs. Clinicians should recognize delirium's detrimental effects in this vulnerable group and adhere to preventive protocols for improved care. [ABSTRACT FROM AUTHOR]

Providing timely and effective care for patients with sepsis is challenging due to delays in recognition and intervention. The Surviving Sepsis Campaign has developed bundles that have been shown to reduce sepsis mortality. However, hospitals have not consistently adhered to these bundles, resulting in suboptimal outcomes. To address this, a multimodal quality improvement sepsis program was implemented from 2017 to 2022 in a large urban tertiary hospital. The aim of this program was to enhance the Severe Sepsis and Septic Shock Management Bundle compliance and reduce sepsis mortality. At baseline, the Severe Sepsis and Septic Shock Management Bundle compliance rates were low, at 25%, with a sepsis observed/expected mortality ratio of 1.14. Our interventions included the formation of a multidisciplinary committee, the appointment of sepsis champions, the implementation of sepsis alerts and order sets, the formation of a Code Sepsis team, real-time audits, and peer-to-peer education. By 2022, compliance rose to 62%, and the observed/expected mortality ratio decreased to 0.73. Our approach led to improved outcomes and hospital rankings. These findings underscore the efficacy of a comprehensive sepsis care initiative, emphasizing the importance of interdisciplinary collaboration. A multimodal hospital-wide sepsis performance program is feasible and can contribute to improved outcomes. However, further research is necessary to determine the specific impact of individual strategies on sepsis outcomes. [ABSTRACT FROM AUTHOR]

Pediatric heart transplant (HT) candidates experience high waitlist mortality due to a limited donor pool that is constrained in part by anti-HLA sensitization. We evaluated the impact of CDC and Flow donor-specific crossmatch (XM) results on pediatric HT outcomes. All pediatric HTs between 1999 and 2019 in the OPTN database were included. Donor-specific XM results were sub-categorized based on CDC and Flow results. Primary outcomes were treated rejection in the first year and time to death or allograft loss. Propensity scores were utilized to adjust for differences in baseline characteristics. A total of 4,695 pediatric HT patients with T-cell XM data were included. After propensity score adjustment, a positive T-cell CDC-XM was associated with 2 times higher odds of treated rejection (OR 2.29 (1.56, 3.37)) and shorter time to death/allograft loss (HR 1.50 (1.19, 1.88)) compared to a negative Flow-XM. HT recipients who were Flow-XM positive with negative/unknown CDC-XM did not have higher odds of rejection or shorter time to death/allograft loss. An isolated positive B-cell XM was also not associated with worse outcomes. Over the study period XM testing shifted from CDC- to Flow-based assays. A positive donor-specific T-cell CDC-XM was associated with rejection and death/allograft loss following pediatric HT. This association was not observed with a positive T-cell Flow-XM or B-cell XM result alone. The shift away from performing the CDC-XM may result in loss of important prognostic information unless the clinical relevance of quantitative Flow-XM results on heart transplant outcomes is systematically studied. [ABSTRACT FROM AUTHOR]

Background: Volume overload (VO) is common in the intensive care unit (ICU) and associated with negative outcomes. Approaches have been investigated to curtail VO; however, none specifically focused on medication diluent volume optimization. Objective: Investigate the impact of a pharmacist-driven medication diluent volume optimization protocol on fluid balance in critically ill patients. Methods: A prospective, pilot study was conducted in a medical ICU during October 2021 to December 2021 (pre) and February 2022 to April 2022 (post). A pharmacist-driven medication diluent volume optimization protocol focusing on vasopressor and antimicrobial diluent volumes was implemented. Demographics and clinical data were collected during ICU admission up to 7 days. The primary outcome was net fluid balance on day 3. Secondary outcomes were medication volumes administered, net fluid balance, ICU length of stay, and mortality. Results: Supply chain shortages caused the study to stop at the end of February 2022. Overall, 152 patients were included (123 pre group, 29 post group). The most common admission diagnosis was acute respiratory failure (35%). Vasopressors and antimicrobials were utilized in 47% and 66% of patients, respectively. Net fluid balance on day 3 was greater but not significant in the post group (227.1 mL [−1840.3 to 3483.7] vs 2012.3 mL [−2686.0 to 4846.0]; P =.584). Antimicrobial diluent volumes were significantly less in the post group. No differences were seen in other secondary outcomes. Protocol group assignment was not associated with net fluid balance on day 3. Conclusion: Despite decreasing antimicrobial volume contributions, optimizing diluent volumes alone did not significantly impact overall volume status. Future studies should focus on comprehensive approaches to medication diluent optimization and fluid stewardship. [ABSTRACT FROM AUTHOR]

Background: Infectious diseases (ID) pharmacists are pivotal members of antimicrobial stewardship teams. Prospective audit and feedback is a strong recommendation by The Infectious Diseases Society of America Guidelines for Antimicrobial Stewardship Programs (ASP). Utilizing customized ASP intervention documentation tools known as "ivents" in Epic, we aimed to assess the impact of interventions by measuring outcomes that were accepted compared to those that were rejected in a multihospital health system over 5 years. Methods: A multicenter, retrospective cohort study was conducted to compare clinical outcomes among intensive care unit (ICU) and non-ICU patients with accepted and rejected ASP interventions over 5 years from October 2015 to December 2020. Outcomes measured included antibiotic days of therapy per 1000 patient days (DOT/1000 PD), antibiotic doses per 1000 patient days (doses/1000 PD), hospital length of stay (LOS), in-hospital mortality, hospital-acquired Clostridioides difficile infection (HA-CDI), community-onset C. difficile infection (CO-CDI) within 30 days, and hospital readmission within 30 days. Coarsened exact matching (CEM) was used as a non-parametric matching method to balance covariates between groups and to control for confounding. Results: ASP recommendations by ID pharmacists were well-received by providers in a multihospital system over 5 years as evidenced by an overall acceptance rate of 92%. Acceptance of ASP interventions was associated with substantial reductions in antibiotic utilization without adversely affecting mortality or hospital readmissions. While high-risk C. difficile antibiotic use increased significantly due to frequent de-escalation to ceftriaxone among non-ICU patients with accepted interventions, rates of HA-CDI and CO-CDI within 30 days did not worsen. Furthermore, hospital LOS was notably shorter by an average of 1 day for non-ICU patients with accepted interventions, which resulted in substantial cost avoidance of $7 631 400. Conclusion: Collaboration with ID pharmacists to optimize antimicrobial stewardship was associated with significant reductions in antibiotic utilization, costs, and hospital LOS without worsening patient outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Previous social prescribing work highlights a range in the types and number of outcomes used in published studies. We aimed to describe social prescribing outcome core areas and instruments to build capacity for future research and program evaluation. Methods: This was a modified umbrella review following standard guidelines. We registered the study and searched multiple databases (all languages and years); inclusion criteria were peer-reviewed publications containing outcomes for self-described social prescribing for adults aged 18 years and older. The last search date was 9 July 2023. From the included systematic reviews, we identified primary studies using the same inclusion criteria. For primary studies, we sorted extracted outcomes and instruments into six core areas using a published taxonomy. We located information on instruments' description and measurement properties and conducted two rating rounds for (1) the quality of systematic reviews and (2) reporting of instruments in primary studies. We conducted a narrative synthesis of reviews, primary studies and outcomes (PROSPERO 2023 CRD42023434061). Results: We identified 10 systematic reviews and 33 primary studies for inclusion in our review. Outcomes covered most core taxonomy areas, with an emphasis on psychosocial factors (e.g. well-being) and less emphasis on cognition, physical activity, and caregivers and volunteers. We noted few studies provided detailed information on demographic data of participants or measurement properties of instruments. Conclusion: This synthesis provides an overview and identifies knowledge gaps for outcomes and instruments used in social prescribing interventions. This work forms the basis of our next step of identifying social prescribing-related outcomes that matter most across interested parties, such as individuals providers and decision makers. [ABSTRACT FROM AUTHOR]

Background The COVID-19 lockdowns had negative effects on children’s and adults’ mental and physical health. There is, however, a paucity of research that explores differences in health-related quality of life (HRQL) and well-being over time after the COVID-19 lockdowns had been lifted. Furlough during lockdowns, increases in unemployment, and the emerging cost-of-living crisis all put pressure on family finances, which could have a detrimental effect on HRQL and well-being. This study, part of the wider Active-6 study, explored how HRQL, capability well-being and family financial strain changed after the lockdowns, the relationship between these outcomes, and whether physical activity had any mediating effect on differences in HRQL and capability well-being. Methods Cross-sectional data were collected in May–December 2021 (Wave 1) and January–July 2022 (Wave 2). Children (aged 10–11) and their parent/carer were recruited from 23 to 27 schools in each wave, respectively, and completed validated questionnaires measuring HRQL (adults – EQ-5D-5L, children – CHU9D), capability well-being (adults – ICECAP-A) and family financial strain (adults – Family Economic Strain Scale, FESS). Children also completed questions on capability well-being. Weekday minutes of moderate-to-vigorous physical activity (MVPA) were measured using accelerometers. Mixed-effects regression models, adjusted for gender, age group (adults only), IMD and highest household education, were used to explore differences in HRQL and capability well-being between waves. In addition, the moderating effect of financial strain and the mediating effect of MVPA on HRQL and capability well-being were explored. Results Active-6 recruited 393 parent-child pairs in Wave 1 and 436 in Wave 2. There were no differences in HRQL (EQ-5D, CHU9D) and capability well-being (ICECAP-A) scores between waves, but financial strain was worse in Wave 2 compared to Wave 1 (FESS score difference 1.14 adjusted 95% CI 0.15 to 2.12). Increased financial strain was associated with lower (worse) EQ-5D-5L, CHU9D and ICECAP-A scores. There was no evidence of a mediating effect of MVPA. Limitations and future work Pre-COVID-19 data on HRQL were not collected, so analysis was limited to post-lockdown only. Participating parents were predominantly female and participation was lower among lower socio-economic groups, limiting our ability to explore inequalities. Intervention planning to increase physical activity and health and well-being during the COVID-19 recovery should consider the financial strain families are experiencing and the negative implications of financial strain on HRQL. Conclusions There were no differences in HRQL and capability well-being in children and adults after lockdowns lifted in 2021 and a year later in 2022. The results indicate increasing financial strain, which could reflect the UK’s ‘cost of living crisis’. Funding This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131847. Plain language summary Why did we do this study? We know that the COVID-19 pandemic negatively affected people’s mental and physical health. But we don’t know how quality of life, well-being and pressure on family finances changed for people after the lockdowns were lifted and society reopened. We also wanted to know if these changes were related to how physically active people were. What did we do? Children and a parent/carer answered questions about their quality of life, well-being and family budget pressures. Physical activity data were also collected using devices worn on their waists. We did this in 2021, when society started to reopen after lockdowns, and a year later in 2022 when all restrictions were gone. We explored differences in quality of life, well-being and pressure on family finances between 2021 and 2022. We then looked at whether any of these differences were because of changes in physical activity, and if financial strain was related to quality of life. What did we find? We did not find any differences in quality of life or well-being between 2021 and 2022. Financial strain increased slightly. As financial strain increased, quality of life and well-being decreased. This was worse for those experiencing most financial difficulties. Physical activity did not seem to explain differences in quality of life. What does this mean? If family finances are stretched, it might be difficult for families to pay for activities that will help their children be more active. We have also found that family financial difficulties are related to quality of life and well-being.

This paper is derived from a presentation given by the first author at the 2024 Symposium for the Calvin Schwabe Award, presented to Dr. Jan Sargeant for Lifetime Achievement in Veterinary Epidemiology and Preventive Medicine. Researchers must work toward ensuring validity throughout the research process, but we also should ensure that our resulting outcomes are specified to appropriately inform and enable decision-making by the end-users. Given the scope and diversity of topics addressed by veterinary researchers, the potential beneficiaries or stakeholders of our research also varies. Stakeholders or end-users may include veterinary practitioners, other researchers, livestock owners, “pet parents,” government officials, corporate entities, or the general public in the case of public health or food security and safety issues. Current research in animal agriculture provides an opportunity to consider research outcomes in a sustainability framework which concurrently values social, economic, and environment impacts of animal health and management decisions. In companion animals, contemporary issues of affordability and access to care, quality of life, or compliance effects on efficacy, also extend the spectrum of relevant research outcomes. In these cases, traditional measures of animal health, such as morbidity, mortality, or weight gain, may not be the most relevant for the end-users. Furthermore, if studies are not designed and analyzed with well-defined primary outcomes that are informed by stakeholders’ values, but rather post-hoc considerations of these values are made based on indirect or surrogate measures, there is the potential to incorporate error and bias into our conclusions and the end-users’ decision-making processes.

Abstract Background Previous studies found that documentation of comorbidities differed when Veterans received care within versus outside Veterans Health Administration (VHA). Changes to medical center funding, increased attention to performance reporting, and expansion of Clinical Documentation Improvement programs, however, may have caused coding in VHA to change. Methods Using repeated cross-sectional data, we compared Elixhauser-van Walraven scores and Medicare Severity Diagnosis Related Group (DRG) severity levels for Veterans’ admissions across settings and payers over time, utilizing a linkage of VHA and all-payer discharge data for 2012–2017 in seven US states. To minimize selection bias, we analyzed records for Veterans admitted to both VHA and non-VHA hospitals in the same year. Using generalized linear models, we adjusted for patient and hospital characteristics. Results Following adjustment, VHA admissions consistently had the lowest predicted mean comorbidity scores (4.44 (95% CI 4.34–4.55)) and lowest probability of using the most severe DRG (22.1% (95% CI 21.4%-22.8%)). In contrast, Medicare-covered admissions had the highest predicted mean comorbidity score (5.71 (95% CI 5.56–5.85)) and highest probability of using the top DRG (35.3% (95% CI 34.2%-36.4%)). Conclusions More effective strategies may be needed to improve VHA documentation, and current risk-adjusted comparisons should account for differences in coding intensity.

Maryia Zhdanava,1 Sumesh Kachroo,2 Aditi Shah,1 Zhijie Ding,2 Patrick Lefebvre,1 Ruizhi Zhao,2 Caroline Kerner,2 Dominic Pilon1 1Analysis Group, Inc, Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Horsham, PA, USACorrespondence: Maryia Zhdanava, Analysis Group, Inc, 1190 avenue des Canadiens-de-Montréal, Suite 1500, Montréal, QC, H3B 0G7, Canada, Tel +1-514-394-4469, Fax +1-514-394-4461, Email Masha.Zhdanava@analysisgroup.comPurpose: To describe real-world persistence in bio-naïve and bio-experienced adults with ulcerative colitis (UC) treated with ustekinumab, a recently approved anti-interleukin 12/23 antibody, or adalimumab, an anti-TNF biologic.Methods: This is a descriptive, retrospective cohort study. Patients initiating ustekinumab or adalimumab (index date, between 10/21/2019 and 08/13/2021) were selected from the Komodo Health comprehensive dataset and stratified into bio-naïve and bio-experienced subgroups based on biologic use 12 months pre-index date. Endpoints evaluated at 12-months after maintenance phase start using Kaplan–Meier analysis included 1) persistence; 2) persistence while being corticosteroid-free (< 14 consecutive days of corticosteroid supply after day 90 post-index); and, 3) persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies).Results: Ustekinumab cohort included 778 patients (236 bio-naïve, 542 bio-experienced) and adalimumab cohort included 1693 patients (1517 bio-naive, 176 bio-experienced). At 12 months after maintenance phase start, 75.5% and 50.5% of bio-naïve patients persisted on ustekinumab and adalimumab and 72.3% and 56.9% of bio-experienced patients persisted on ustekinumab and adalimumab, respectively. Further, 55.1% and 38.2% of bio-naïve patients were persistent and corticosteroid-free with ustekinumab and adalimumab; 43.7% and 33.4% of bio-experienced patients were persistent and corticosteroid-free with ustekinumab and adalimumab, respectively. Moreover, 68.1% and 44.5% of bio-naïve patients were persistent and on monotherapy with ustekinumab and adalimumab; 61.6% and 47.9% of bio-experienced patients were persistent and on monotherapy with ustekinumab and adalimumab, respectively.Conclusion: At 12 months after maintenance phase start, patients with UC treated with ustekinumab had numerically higher persistence, including persistence while corticosteroid-free and persistence while on monotherapy, than patients treated with adalimumab.Keywords: biologics, inflammatory bowel disease, outcomes research

BACKGROUND: The COVID-19 pandemic has posed tremendous stress on the health care system. Its effects on pediatric/congenital catheterization program practice and performance have not been described. OBJECTIVES: The purpose of this study was to evaluate how case volumes, risk-profile, and outcomes of pediatric/congenital catheterization procedures changed in response to the first wave of COVID-19 and after that wave. METHODS: A multicenter retrospective observational study was performed using Congenital Cardiac Catheterization Project on Outcomes Registry (C3PO) data to study changes in volume, case mix, and outcomes (high-severity adverse events [HSAEs]) during the first wave of COVID (March 1, 2020, to May 31, 2020) in comparison to the period prior to (January 1, 2019, to February 28, 2020) and after (June 1, 2020, to December 31, 2020) the first wave. Multivariable analyses adjusting for case type, hemodynamic vulnerability, and age group were performed. Hospital responses to the first wave were captured with an electronic study instrument. RESULTS: During the study period, 12,557 cases were performed at 14 C3PO hospitals (with 8% performed during the first wave of COVID and 32% in the postperiod). Center case volumes decreased from a median 32.1 cases/month (IQR: 20.7-49.0 cases/month) before COVID to 22 cases/month (IQR: 13-31 cases/month) during the first wave (P = 0.001). The proportion of cases with risk factors for HSAE increased during the first wave, specifically proportions of infants and neonates (P

BackgroundThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a Patient-Reported Outcome Measure (PROM) used to evaluate the health status of patients with heart failure (HF) but has predominantly been tested in settings serving predominately white, male, and economically well-resourced populations. We sought to examine the acceptability of the shorter version of the KCCQ (KCCQ-12) among racially and ethnically diverse patients receiving care in an urban, safety-net setting.MethodsWe conducted cognitive interviews with a diverse population of patients with heart failure in a safety net system to assess their perceptions of the KCCQ-12. We conducted a thematic analysis of the qualitative data then mapped themes to the Capability, Opportunity, Motivation Model of Behavior framework.ResultsWe interviewed 18 patients with heart failure and found that patients broadly endorsed the concepts of the KCCQ-12 with minor suggestions to improve the instrument's content and appearance. Although patients accepted the KCCQ-12, we found that the instrument did not adequately measure aspects of health care and quality of life that patients identified as being important components of managing their heart failure. Patient-important factors of heart failure management coalesced into three main themes: social support, health care environment, and mental health.ConclusionsPatients from this diverse, low-income, majority non-white population experience unique challenges and circumstances that impact their ability to manage disease. In this study, patients were receptive to the KCCQ-12 as a tool but perceived that it did not adequately capture key health components such as mental health and social relationships that deeply impact their ability to manage HF. Further study on the incorporation of social determinants of health into PROMs could make them more useful tools in evaluating and managing HF in diverse, underserved populations.

Objective To analyse patients with RA for inflammatory activity by physician estimate of global assessment (DOCGL) vs an estimate of inflammatory activity (DOCINF) to explain variation in the swollen joint count (SJC). Methods Patients with RA were studied at routine care visits. Patients completed a multidimensional health assessment questionnaire (MDHAQ) and the physician completed a 28-joint count for swollen (SJC), tender (TJC) and deformed (DJC) joints and a RheuMetric checklist with a 0–10 DOCGL visual numeric scale (VNS) and 0–10 VNS estimates of inflammation (DOCINF), damage (DOCDAM) and patient distress (DOCSTR). The disease activity score in 28 joints with ESR (DAS28-ESR), Clinical Disease Activity Index (CDAI) and Routine Assessment of Patient Index Data 3 (RAPID3) were calculated. Individual scores and RA indices were compared according to Spearman correlation coefficients and regression analyses. Results A total of 104 unselected patients were included, with a median age and disease duration of 54.5 and 5 years, respectively. The median DAS28-ESR was 2.9 (Q1–Q3: 2.0–3.7), indicating low activity. DOCINF was correlated significantly with DOCGL (ρ = 0.775). Both DOCGL and DOCINF were correlated significantly with most other measures; correlations with DOCGL were generally higher than with DOCINF other than for SJC. In regression analyses, DOCINF was more explanatory of variation in SJC than DOCGL and other DAS28-ESR components. Conclusions Variation in SJC is explained more by a 0–10 DOCINF VNS than the traditional DOCGL or any other measure in RA patients seen in routine care. DOCINF on a RheuMetric checklist can provide informative quantitative scores concerning inflammatory activity in RA patients monitored over long periods. [ABSTRACT FROM AUTHOR]

We examined the association of socioeconomic status as defined by median household income quartile (MHIQ) with mortality and readmission patterns following open repair of acute type A aortic dissection (ATAAD) in a nationally representative registry. Adults who underwent open repair of ATAAD were selected using the US Nationwide Readmissions Database and stratified by MHIQ. Patients were selected based on diagnostic and procedural codes. The primary endpoint was 30-d readmission. Between 2016 and 2019, 10,288 individuals (65% male) underwent open repair for ATAAD. Individuals in the lowest income quartile were younger (median: 60 versus 64, P < 0.05) but had greater Elixhauser comorbidity burden (5.9 versus 5.7, P < 0.05). Across all groups, in-hospital mortality was approximately 15% (P = 0.35). On multivariable analysis adjusting for baseline comorbidity burden, low socioeconomic status was associated with increased readmission at 90 d, but not at 30 d. Concomitant renal disease (odds ratio [OR], 1.68; P < 0.001), pulmonary disease (OR, 1.26; P < 0.001), liver failure (OR 1.2, P = 0.04), and heart failure (OR, 1.17; P < 0.001) were all associated with readmission at 90 d. The primary indication for readmission was most commonly cardiac (33%), infectious (16.5%), and respiratory (9%). In patients who undergo surgery for ATAAD, lower MHIQ was associated with higher odds of readmission following open repair. While early readmission for individuals living in the lowest income communities is likely attributable to greater baseline comorbidity burden, we observed that 90-d readmission rates are associated with lower MHIQ regardless of comorbidity burden. Further investigation is required to determine which patient-level and system-level interventions are needed to reduce readmissions in the immediate postoperative period for resource poor areas. [ABSTRACT FROM AUTHOR]

Background: The American Heart Association has a call to action to reduce hospital acquired venous thromboembolism (HA-VTE) by 20% by the year 2030. There is increasing recognition that quality improvement initiatives for VTE reduction should focus on reducing potentially preventable HA-VTE. The objective of our study was to determine what proportion of HA-VTE events are potentially preventable. Methods: This was a retrospective, single center pilot study of 50 patients with HA-VTE. Seven preventability factors were identified with a focus on VTE prescription and administration. Data were extracted through chart review using a systematic data collection form. The primary endpoint was the proportion of patients with potentially preventable HA-VTE. Descriptive statistics were used. Results: The median age was 66 years with an admission VTE risk level of moderate-high in 94%. Potentially preventable HA-VTE was found in 40% of cases. Missed doses occurred in 29.8% with a median of 2 missed doses and a range of 1 to 20. Patient refusal was the most common reason for missed doses in 71%. Delays in initiation occurred in 12.7%. Sixty percent of those on mechanical prophylaxis only had nonadherence. Conclusion: Forty percent of HA-VTE cases were potentially preventable. Missed doses was the most common preventability factor identified with patient refusal accounting for most missed doses. [ABSTRACT FROM AUTHOR]

• As of August 18th, 2022, the COVID-19 pandemic has claimed over 6,400,000 lives worldwide and over 1,000,000 lives in the United States. • Prior retrospective studies exist in the literature, documenting that statins have a mortality benefit in patients hospitalized with COVID-19. These studies have focused on populations with a high proportion of Caucasians. • This retrospective study examines a population that is majority African American and found no benefit of statins in patients hospitalized with COVID-19 in mortality, survival time, need for ICU care, length of ICU stay, need for ventilator, duration of intubation, or need for dialysis. • Further research should be done examining the interplay between COVID-19, statins, and race/ethnicity to better elucidate whether statins have any beneficial effect in decreasing mortality caused by COVID-19. The COVID-19 pandemic has claimed over 6.4 million lives globally. Finding effective medications to reduce mortality in hospitalized COVID-19 patients remains critical. No previous study has been published on the effects of statin use in a majority African American COVID-19 patient population. This study aims to assess the relationship between in-hospital statin use and mortality in this population. A retrospective chart review of patients diagnosed with COVID-19 from March 2020 to June 2020 admitted to the Phoebe Putney Health System in Albany, Georgia, an early epicenter of the COVID-19 pandemic, was conducted. The outcomes of 735 hospitalized COVID-19 positive patients from over 40 counties in Georgia were analyzed. The primary outcome of interest was all-cause mortality, with secondary outcomes of interest of ICU care, length of ICU stay, need for mechanical ventilator, duration of intubation, and need for dialysis. Multivariate logistic regression and Cox proportional hazards analysis were conducted to examine the effect of in-hospital statin use and mortality. 186 of 735 total patients were prescribed statins in-hospital. 83.8% were African American. Multivariate logistic regression found in-hospital statin use was not significantly associated with the primary outcome – all-cause mortality (p=0.23). Similar findings were seen in need for ICU care, length of ICU stay, need for mechanical ventilator, duration of intubation, and need for dialysis (p>0.05). Additionally, results from a Cox proportional hazards model found in-hospital statin use was not associated with survival time. Sensitivity analysis conducted on only African American patients validated that in-hospital statin use was not associated with all-cause mortality in these patients. Of note, immunosuppression and severe disease presentation were associated with a six-fold increase in risk of mortality and the largest decreases in survival time. It is possible statins have no mortality benefit for this patient population, but further research beyond this association study would need to be conducted to determine this conclusively. From this study, the best clinical recommendation would be to continue statins for COVID-19 patients with pre-hospital statin use and to launch a randomized clinical trial to definitively determine the efficacy of statins in the treatment of hospitalized COVID-19 patients. [ABSTRACT FROM AUTHOR]

The Wound‐QoL assesses the impact of chronic wounds on patients' health‐related quality of life (HRQoL). A 17‐item and a shortened 14‐item version are available. The Wound‐QoL‐17 has been validated for multiple languages. For the Wound‐QoL‐14, psychometric properties beyond internal consistency were lacking. We aimed to validate both Wound‐QoL versions for international samples representing a broad range of European countries, including countries for which validation data had yet been pending. Patients with chronic wounds of any aetiology or location were recruited in Austria, Lithuania, the Netherlands, Poland, Slovakia, Spain, Switzerland and Ukraine. Psychometric properties were determined for both Wound‐QoL versions for the overall sample and, if feasible, country‐wise. We included 305 patients (age 68.5 years; 52.8% males). Internal consistency was high in both Wound‐QoL‐17 (Cronbach's α: 0.820–0.933) and Wound‐QoL‐14 (0.779–0.925). Test–retest reliability was moderate to good (intraclass correlation coefficient: 0.618–0.808). For Wound‐QoL‐17 and Wound‐QoL‐14, convergent validity analyses showed highest correlations with global HRQoL rating (r = 0.765; r = 0.751) and DLQI total score (r = 0.684; r = 0.681). Regarding clinical data, correlations were largest with odour (r = −0.371; r = −0.388) and wound size (r = 0.381; r = 0.383). Country‐wise results were similar. Both Wound‐QoL versions are valid to assess HRQoL of patients with chronic wounds. Due to its psychometric properties and brevity, the Wound‐QoL‐14 might be preferrable in clinical practice where time is rare. The availability of various language versions allows for the use of this questionnaire in international studies and in clinical practice when foreign language patients are being treated. [ABSTRACT FROM AUTHOR]

Background: Troponin is a biomarker of myocardial injury and death but has not been well studied after pediatric heart transplants. The objective of this analysis is to describe the distribution and clinical determinants of serum troponin measured in the first week after pediatric heart transplantation. Methods: We included all patients who underwent heart transplantation at Seattle Children’s Hospital between 2012 and 2016. Serum Troponin-I (TnI) was measured daily in the first week after transplant. We described the distribution of serum TnI, and examined the relationship between peak TnI with known pre- peri-operative risk factors for myocardial injury including etiology of heart failure, ischemia time, and donor to recipient characteristics. Logistic regression models were used to test the association between peak TnI with incidence of death or rejection and formation of donor-specific antibodies (DSA) within 1 year. Adjusted models included age, HF etiology, crossmatch status, and panel reactive antibodies. Results: During the study period, 86 transplants were performed on 83 unique individuals. Serum TnI peaked at a median of 0.9 days after transplantation. In adjusted models, higher peak TnI was associated with death and/or rejection within 1-year post-transplant (odds ratio [95% confidence interval]: 1.10 [1.02, 1.19]). Peak TnI was not associated with de-novo DSA formation in adjusted models (OR [95%CI]: 1.01 [0.94, 1.09]). Post-transplant length of stay in the intensive care unit was positively correlated with peak TnI (r = 0.36, p

Objective: Knee osteoarthritis (OA) is a disease of the whole joint involving multiple tissue types. MRI-based semi-quantitative (SQ) scoring of knee OA is a method to perform multi-tissue joint assessment and has been shown to be a valid and reliable way to measure structural multi-tissue involvement and progression of the disease. While recent work has described how SQ scoring may be used for clinical trial enrichment and disease phenotyping in OA, less guidance is available for how these parameters may be used to assess study outcomes. Design: Here we present recommendations for summarizing disease progression within specific tissue types. We illustrate how various methods may be used to quantify longitudinal change using SQ scoring and review examples from the literature. Results: Approaches to quantify longitudinal change across subregions include the count of number of subregions, delta-subregion, delta-sum, and maximum grade changes. Careful attention should be paid to features that may fluctuate, such as bone marrow lesions, or with certain interventions, for example pharmacologic interventions with anticipated cartilage anabolic effects. The statistical approach must align with the nature of the outcome. Conclusions: SQ scoring presents a way to understand disease progression across the whole joint. As OA is increasingly recognized as a heterogeneous disease with different phenotypes a better understanding of longitudinal progression across tissue types may present an opportunity to match study outcome to patient phenotype or to treatment mechanism of action.

Abstract Background Microbiome restitution therapies are being developed to prevent gut pathogen colonization among patients in the intensive care unit (ICU) and in other select populations. If preventive therapies are to be effective, they must be administered prior to pathogen acquisition. The timing and risk factors for early acquisition of gut pathogen colonization (within 72 h) are currently unknown and could be helpful to guide ICU trial design. Methods This was a prospective cohort study. Patients in the ICU had deep rectal swabs performed within 4 h of ICU admission and exactly 72 h later. Early gut pathogen colonization was classified as the new presence (based on culture of rectal swabs) of one or more of the following organisms of interest: methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant (VRE), and Gram-negative bacteria that showed multidrug resistance (MDR) or third generation Cephalosporin resistance (Ceph-R). Clinical risk factors for early acquisition of gut pathogen colonization were captured using the Acute Physiology and Chronic Health Evaluation IV (APACHE IV) scoring system. Findings Among 131 patients who were swabbed at ICU admission and 72 h later, the rates of gut pathogen colonization at ICU admission were 11.4%, 10.6%, 38.6%, and 8.3% for MRSA, VRE, MDR and Ceph-R Gram-negatives respectively. Among the patients who were negative for a given pathogen at ICU admission, the rates of early acquisition of gut pathogen colonization were 7.8% for MRSA (95% CI 3.6 to 14.2%), 7.7% for VRE (95% CI 3.6 to 14.1%), 11.3% for MDR Gram-negatives (95% CI 4.4 to 18.8%), and 4.2% for Ceph-R Gram-negatives (95% CI 1.4 to 9.5%). There were no clinical risk factors which independently predicted early acquisition of gut pathogen colonization. Interpretation Early gut pathogen colonization was common in the ICU, but our single-center study could not identify any clinical risk factors which were significantly associated with acquisition of gut pathogens.

BackgroundContemporary data on national trends and outcomes in cardiac resynchronization therapy with defibrillator (CRT-D) recipients following the 2012 updated guidelines has not been studied.ObjectivesThis study assessed the trends in long-term outcomes among CRT-D Medicare-aged recipients implanted in 2011-2015.MethodsPatients aged ≥65 years undergoing de novo CRT-D implantation in the National Cardiovascular Data Implantable Cardiac Defibrillator Registry from 2011-2015 with follow-up through 2017 using Medicare data were included and stratified by year of implant. Patient characteristics, in-hospital outcomes, and outcomes up to 2 years following implant were evaluated.ResultsAmong 53,174 patients (aged 75.6-6.4 years, 29.7% women) implanted with CRT-D from 2011 to 2015, there was an increase in implantations based on guideline-concordant recommendations (81.0% to 84.7%, P < .001). Compared to 2011, in-hospital procedural complications decreased in 2015 (3.9% vs 2.9%; adjusted odds ratio, 0.76, 95% confidence interval, 0.66-0.88, P < .001), driven in part by decreased lead dislodgement (1.4% vs 1.0%). After multivariable adjustment, there was a lower risk of all-cause hospitalization, cardiovascular hospitalization, and mortality at 2-year follow-up in 2015 as compared to 2011, while there were no differences in heart failure hospitalizations at follow-up.ConclusionAmong Medicare beneficiaries receiving CRT-D from 2011 to 2015, there was an increase in implantations based on guideline-concordant recommendations. Furthermore, there has been a reduction in in-hospital complications and long-term outcomes, including cardiovascular hospitalization, all-cause hospitalization, and mortality; however, there has been no difference in the risk of heart failure hospitalization after adjustment.

Background Despite improved outcomes associated with ticagrelor compared with clopidogrel in acute coronary syndrome (ACS), many studies have demonstrated slow adoption of ticagrelor in the United States because of its increased cost. Less is known about how ticagrelor is adopted when there is no added cost consideration. Our objectives were to determine patterns of use of ticagrelor, hospital-level adoption of ticagrelor use, and factors associated with its use after ACS in a publicly funded health care system. Methods and Results We conducted a population-based cohort study including patients (≥65 years) hospitalized with their first ACS from April 2014 to March 2018 in Ontario, Canada. We determined temporal trends in ticagrelor use and hospital-level adoption of its use post-ACS discharge. Using hierarchical regression models, we identified significant predictors of ticagrelor use. There were 23 962 patients with ACS (mean age 76.3 years, 59.7% men) hospitalized in 156 hospitals. Overall ticagrelor use increased from 32.6% in 2014/2015 to 51.8% in 2017/2018. There was substantial variation in ticagrelor use post-ACS across hospitals, with hospital-specific prescribing rates ranging from 0% to 83.6%. Lower odds of ticagrelor use was associated with advanced age and the presence of comorbidities. Besides patient factors, being admitted to a rurally located hospital more than halved the odds of being prescribed ticagrelor (odds ratio [OR], 0.49; 95% CI, 0.32-0.77). Being managed by a cardiologist during the index ACS hospitalization was associated with higher odds of having a ticagrelor prescription after ACS (OR, 2.80; 95% CI, 2.36-3.33). Conclusions Ticagrelor use rates varied substantially across hospitals and were strongly associated with physician and hospital factors independent of patient characteristics.

BackgroundThe interaction between cancer diagnoses and COVID-19 infection and outcomes is unclear. We leveraged a state-wide, multi-institutional database to assess cancer-related risk factors for poor COVID-19 outcomes.MethodsWe conducted a retrospective cohort study using the University of California Health COVID Research Dataset, which includes electronic health data of patients tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at 17 California medical centers. We identified adults tested for SARS-CoV-2 from 2/1/2020-12/31/2020 and selected a cohort of patients with cancer. We obtained demographic, clinical, cancer type, and antineoplastic therapy data. The primary outcome was hospitalization within 30d after the first positive SARS-CoV-2 test. Secondary outcomes were SARS-CoV-2 positivity and severe COVID-19 (intensive care, mechanical ventilation, or death within 30d after the first positive test). We used multivariable logistic regression to identify cancer-related factors associated with outcomes.ResultsWe identified 409,462 patients undergoing SARS-CoV-2 testing. Of 49,918 patients with cancer, 1781 (3.6%) tested positive. Patients with cancer were less likely to test positive (RR 0.70, 95% CI: 0.67-0.74, p