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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

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.

Introduction: This study evaluates the financial impact on healthcare payers when chronic pain patients initiate peripheral nerve stimulation (PNS) with a 60-day percutaneous PNS (60-Day PNS) treatment versus a conventional brief PNS trial (PNS-BT) with possible follow-on of a permanently implanted PNS system (PNS-PI). Methods: Centers for Medicare & Medicaid Services (CMS) fee-for-service (FFS) data were analyzed to identify patients with at least 12 months of follow-up (median 26.4 months) who initiated PNS treatment with: (1) 60-Day PNS or (2) PNS-BT. An economic decision tree model assessed the cost to payers in each cohort. Clinical response to 60-Day PNS was estimated by retrospectively reviewing anonymized outcomes from a national real-world database, focusing on patients ≥ 65 years of age who were implanted with a 60-day percutaneous PNS system. For the economic model, a Monte Carlo simulation with 10,000 iterations was used to generate 95% confidence intervals, considering variability in treatment outcome probability and costs. Results: Based on CMS data, among 60-Day PNS patients, 18% (229/1265) proceeded to a permanently implanted PNS system with a 4% explant rate (10/229). Among PNS-BT patients, 41% (1140/2811) received a permanent implant with a 7% rate of explant (77/1140). Estimated PNS-related weighted average costs for the 60-Day PNS cohort [US$17,344; 95% confidence interval (CI): $16,168–$18,527] were lower than the PNS-BT cohort ($24,392; 95% CI $22,865–$25,941) when considering the percent of patients who advanced to a permanently implanted PNS system. The total cost per successful outcome also favored 60-Day PNS ($25,228 per success for the 60-Day PNS cohort vs. $64,502 per success for the PNS-BT cohort) as a first-line approach in PNS treatment. Conclusions: The findings suggest that, when PNS for chronic pain is warranted, initiating PNS with a 60-day treatment is more cost-effective than utilizing a brief conventional trial. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to define clinically meaningful phenotypes of intracerebral hemorrhage (ICH) using machine learning. Methods: We used patient data from two US medical centers and the Antihypertensive Treatment of Acute Cerebral Hemorrhage-II clinical trial. We used k-prototypes to partition patient admission data. We then used silhouette method calculations and elbow method heuristics to optimize the clusters. Associations between phenotypes, complications (e.g., seizures), and functional outcomes were assessed using the Kruskal–Wallis H-test or χ2 test. Results: There were 916 patients; the mean age was 63.8 ± 14.1 years, and 426 patients were female (46.5%). Three distinct clinical phenotypes emerged: patients with small hematomas, elevated blood pressure, and Glasgow Coma Scale scores > 12 (n = 141, 26.6%); patients with hematoma expansion and elevated international normalized ratio (n = 204, 38.4%); and patients with median hematoma volumes of 24 (interquartile range 8.2–59.5) mL, who were more frequently Black or African American, and who were likely to have intraventricular hemorrhage (n = 186, 35.0%). There were associations between clinical phenotype and seizure (P = 0.024), length of stay (P = 0.001), discharge disposition (P < 0.001), and death or disability (modified Rankin Scale scores 4–6) at 3-months' follow-up (P < 0.001). We reproduced these three clinical phenotypes of ICH in an independent cohort (n = 385) for external validation. Conclusions: Machine learning identified three phenotypes of ICH that are clinically significant, associated with patient complications, and associated with functional outcomes. Cerebellar hematomas are an additional phenotype underrepresented in our data sources. [ABSTRACT FROM AUTHOR]

The article describes the purpose and promise of health system-based research networks with a focus on the medication-use process (MUP). Topics include the pathway for the development of and participation in one such consortium, challenges critical for this initiative to overcome, and an approach that can be taken to conduct research in all domains of the MUP.

Patients with genitourinary (GU) malignancies have seen the development of multiple life-prolonging treatments in the past decade. As patients and clinicians consider their treatment options along the cancer journey, time spent with healthcare contact, or "time toxicity," has emerged as a new outcome measure that comprehensively considers time receiving cancer care, including planned visits for evaluation and treatment as well as unplanned urgent care addressing complications. Despite its rising study across cancer populations, there has been a surprising lack of work evaluating time toxicity in patients with GU cancers. This narrative review aims to summarize the available studies on time toxicity in cancer, with a deeper dive into the methodology, strengths and limitations, and future directions of the field. A dedicated section focused on scenarios and best practices to measure and collect data on time toxicity can serve to spark interest in evaluating this novel health outcome on GU cancer survivors. Ultimately, time toxicity is a relevant patient-centered metric that can be incorporated into clinical trial design and routine clinical care to influence clinical decision-making. [ABSTRACT FROM AUTHOR]

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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]

As pediatric and adult operative mortality improves, longitudinal outcomes beyond survival become increasingly important. "Days alive and out of hospital" is well-studied as a longitudinal, patient-centered outcome in adult populations. However, it has yet to be validated for children, whose health care use and survival differ from that of adults. This study sought to evaluate days alive and out of health care/hospital as outcomes for neonatal and infant cardiac surgery. Using linked, locally held, clinical registry data, the National Death Index, and Medicaid claims from the CHS-COLOUR (New York Congenital Heart Surgery Collaborative for Longitudinal Outcomes and Utilization of Resources), we describe and compare the distribution of days alive and out of health care/hospital (730 days or date of death minus date of birth, minus the sum of days in health care) over 2 years for New York State Medicaid-enrolled children who underwent initial neonatal or infant cardiac surgery during 2006 to 2018. We assess relative contributions of mortality, inpatient, and outpatient days, test impacts of alternate outpatient day weightings, and assess associations with patient characteristics known to be associated with other, established congenital heart surgical outcomes. In total, 2,519 Medicaid-enrolled neonates/infants underwent initial cardiac surgery in the first year of life across New York state during 2006 to 2018. Days alive and out of health care (DAoH) (0-730 days) was bimodally distributed, with 10.4% (n = 261) spending <100 days and 21.6% (n = 545) spending >700 DAoH. We found that 5.9% (n = 149) of children died during their birth admission (0 DAoH). Cardiac disease complexity, weight at surgery, noncardiac preoperative comorbidities, and other preoperative risk factors were all significantly associated with the outcomes (P <0.001). When considering only inpatient days, the distribution was more left-skewed, because 40% of health care days in the second year of life was attributable to outpatient days. Our findings were otherwise largely insensitive to health care type weightings. In this data set of children with Medicaid coverage, total DAoH is an easily reproducible, patient-centered outcome that should be considered for assessment of longitudinal outcomes for neonates and infants undergoing cardiac surgery. Where outpatient data are not available, days alive and out of hospital might serve as a reasonable alternative. [Display omitted] [ABSTRACT FROM AUTHOR]

Despite the numerous recent trials, systematic reviews and meta-analyses have not conclusively shown superiority of videolaryngoscopy over other techniques for tracheal intubation of children. Clinical trials have shown significant differences using various outcome measures, but the overall clinical evidence remains weak. An international group of experts is currently working on developing good clinical research practice guidelines for paediatric airway management research, with the ultimate aim of identifying a core set of outcomes to be applied to develop future robust and comparable trials. [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

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]

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]

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 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]

Racial/ethnic minorities have demonstrated worse survival after allogeneic hematopoietic cell transplantation (HCT) compared to whites. Whether the racial disparity in HCT outcomes persists in long-term survivors and possibly may be even exacerbated in this population, which frequently transitions back from the transplant center to their local healthcare providers, is unknown. In the current study, we compared long-term outcomes among 1-year allogeneic HCT survivors by race/ethnicity and socioeconomic status (SES). The Center for International Blood and Marrow Transplant Research database was used to identify 5473 patients with acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, or myelodysplastic syndromes who underwent their first allogeneic HCT between 2007 and 2017 and were alive and in remission for at least 1 year after transplantation. The study was restricted to patients who underwent HCT in the United States. SES was defined using patient neighborhood poverty level estimated from the recipients ZIP code of residence; a ZIP code with ≥20% of persons below the federal poverty level was considered a high poverty area. The primary outcome was to evaluate the associations of race/ethnicity and neighborhood poverty level with overall survival (OS), relapse, and nonrelapse mortality (NRM). Cox regression models were used to determine associations of ethnicity/race and SES with OS, relapse, and NRM. Standardized mortality ratios were calculated to compare mortality rates of the study patients and their general population peers matched on race/ethnicity, age, and sex. The study cohort was predominately non-Hispanic white (n = 4385) and also included non-Hispanic black (n = 338), Hispanic (n = 516), and Asian (n = 234) patients. Overall, 729 patients (13%) resided in high-poverty areas. Significantly larger proportions of non-Hispanic black (37%) and Hispanic (26%) patients lived in high-poverty areas compared to non-Hispanic whites (10%) and Asians (10%) (P < .01). Multivariable analysis revealed no significant associations between OS, PFS, relapse, or NRM and race/ethnicity or poverty level when adjusted for patient-, disease- and transplantation-related covariates. Our retrospective cohort registry study shows that among adult allogeneic HCT recipients who survived at least 1 year in remission, there were no associations between race/ethnicity, neighborhood poverty level, and long-term outcomes.

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.

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.

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]

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]

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]

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]

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]

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]

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.

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.

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.