Effects of the valsartan recall on heart failure patients: A nationwide analysis.

BACKGROUND: Valsartan is commonly used for cardiac conditions. In 2018, the Food and Drug Administration recalled generic valsartan due to the detection of impurities. Our objective was to determine if heart failure patients receiving valsartan at the recall date had a greater likelihood of unfavorable outcomes than patients using comparable antihypertensives. METHODS: We conducted a cohort study of Optum's de-identified Clinformatics® Datamart (July 2017-January 2019). Heart failure patients with commercial or Medicare Advantage insurance who received valsartan were compared to persons who received non-recalled angiotensin receptor blockers (ARBs) and angiotensin converting enzyme-inhibitors (ACE-Is) for 1 year prior and including the recall date. Outcomes included a composite for all-cause hospitalization, emergency department (ED), and urgent care (UC) use and a measure of cardiac events which included hospitalizations for acute myocardial infarction and hospitalizations/ED/UC visits for stroke/transient ischemic attack, heart failure or hypertension at 6-months post-recall. Cox proportional hazard models with propensity score weighting compared the risk of outcomes between groups. RESULTS: Of the 87 130 adherent patients, 15% were valsartan users and 85% were users of non-recalled ARBs/ACE-Is. Valsartan use was not associated with an increased risk of all-cause hospitalization/ED/UC use six-months post-recall (HR 1.00; 95% CI 0.96-1.03), compared with individuals taking non-recalled ARBs/ACE-Is. Similarly, cardiac events 6-months post-recall did not differ between individuals on valsartan and non-recalled ARBs/ACE-Is (HR 1.04; 95% CI 0.97-1.12). CONCLUSIONS: The valsartan recall did not affect short-term outcomes of heart failure patients. However, the recall potentially disrupted the medication regimens of patients, possibly straining the healthcare system.

Enrollee characteristics and receipt of colorectal cancer testing in Pennsylvania after adoption of the Affordable Care Act Medicaid expansion.

BACKGROUND: Colorectal cancer (CRC) is the fourth most common cancer and the second leading cause of cancer-related death in the U.S. Despite increased CRC screening rates, they remain low among low-income non-older adults, including Medicaid enrollees who are more likely to be diagnosed at advanced stages. OBJECTIVES: Given limited evidence regarding CRC screening service use among Medicaid enrollees, we examined multilevel factors associated with CRC testing among Medicaid enrollees in Pennsylvania after Medicaid expansion in 2015. RESEARCH DESIGN: Using the 2014-2019 Medicaid administrative data, we performed multivariable logistic regression models to assess factors associated with CRC testing, adjusting for enrollment length and primary care services use. SUBJECTS: We identified 15,439 adults aged 50-64 years newly enrolled through Medicaid expansion. MEASURES: Outcome measures include receiving any CRC testing and by modality. RESULTS: About 32% of our study population received any CRC testing. Significant predictors for any CRC testing include being male, being Hispanic, having any chronic conditions, using primary care services ≤4 times annually, and having a higher county-level median household income. Being 60-64 years at enrollment, using primary care services >4 times annually, and having higher county-level unemployment rates were significantly associated with a decreased likelihood of receiving any CRC tests. CONCLUSIONS: CRC testing rates were low among adults newly enrolled in Medicaid under the Medicaid expansion in Pennsylvania relative to adults with high income. We observed different sets of significant factors associated with CRC testing by modality. Our findings underscore the urgency to tailor strategies by patients' racial, geographic, and clinical conditions for CRC screening.

Pediatric intestine transplant cost: Analysis of the Pediatric Health Information System database.

BACKGROUND: We aimed to evaluate costs from transplant to discharge in children who had undergone intestine transplant. METHODS: We performed a cross-sectional observational study of pediatric intestine transplant recipients from 2004 through 2020, utilizing the Pediatric Health Information System database. Standardized costs were applied to all charges and converted to 2021 US dollars. We analyzed the association of cost from transplant to discharge with age, sex, race and ethnicity, length of stay, insurance type, transplant year, short bowel syndrome diagnosis, liver-containing graft, hospitalization status, and immunosuppressive regimen. Predictors with a P value <0.20 in univariable analysis were included in a multivariable model, which was reduced using backwards selection with a P value of 0.05. RESULTS: We identified 376 intestinal transplant recipients across nine centers (median age, 2 years; 44% female). Most patients had short bowel syndrome (294; 78%). The liver was included in 218 transplants (58%). Median posttransplant cost was $263,724 (interquartile range [IQR], $179,564-$384,147), and length of stay was 51.5 days (IQR, 34-77). In the final model, increased cost from transplant to hospital discharge was associated with liver-containing graft (+$31,805; P = 0.028), T-cell-depleting antibody use (+$77,004; P < 0.001), and mycophenolate mofetil use (+$50,514; P = 0.012) while controlling for insurance type and length of stay. A 60-day posttransplant hospital stay would cost an estimated $272,533. CONCLUSIONS: Intestine transplant has high immediate cost and long length of stay that varies by center, graft type, and immunosuppression regimen. Future work will examine the cost-effectiveness of various management strategies before and after transplant.

Assessment of BMI and Venous Thromboembolism Rates in Patients on Standard Chemoprophylaxis Regimens After Undergoing Free Tissue Transfer to the Head and Neck.

Importance: Venous thromboembolism (VTE) is a severe complication after free tissue transfer to the head and neck (H&N). Enoxaparin 30 mg twice daily (BID) is a common regimen for chemoprophylaxis. However, differences in enoxaparin metabolism based on body weight may influence its efficacy and safety profile. Objective: To assess the association between BMI and postoperative VTE and hematoma rates in patients treated with prophylactic enoxaparin 30 mg BID. Design, Setting, and Participants: This was a retrospective review of a prospectively collected cohort from 2012 to 2022. Postoperative VTE, hematoma, and free flap pedicle thrombosis were recorded within 30 days of index surgery. The setting was a tertiary academic referral center. Participants included patients undergoing H&N reconstruction with free flaps that received fixed-dose subcutaneous enoxaparin 30 mg BID postoperatively. Statistical analysis was conducted from April to May 2022. Main Outcomes and Measures: Outcomes include incidence of VTE, hematoma, and flap pedicle thrombosis events within 30 days of the surgery. Univariate and multivariable regression models were used to evaluate associations between BMI and other patient factors with these outcomes. Results: Among the 765 patients included, 262 (34.24%) were female; mean (SD) age was 60.85 (12.64) years; and mean (SD) BMI was 26.36 (6.29). The rates of VTE and hematoma in the cohort were 3.92% (30 patients) and 5.09% (39 patients), respectively. After adjusting for patient factors, BMI was the only factor associated with VTE (OR, 1.07; 95% CI, 1.015-1.129). Obesity (BMI >30) was associated with increased odds of VTE (OR, 2.782; 95% CI, 1.197-6.564). Hematoma was not associated with BMI (OR, 0.988; 95% CI, 0.937-1.041). Caprini score of at least 9 was not associated with VTE (OR, 1.259; 95% CI, 0.428-3.701). Conclusions and Relevance: This cohort study found that obesity was associated with an increased risk of VTE in patients after microvascular H&N reconstruction and while on standard postoperative chemoprophylaxis regimens. This association may suggest insufficient VTE prophylaxis in this group and a potential indication for weight-based dosing.

The Effect of Geographic Cohorting of Inpatient Teaching Services on Patient Outcomes and Resident Experience.

BACKGROUND: Geographic cohorting is a hospital admission structure in which every patient on a given physician team is admitted to a dedicated hospital unit. Little is known about the long-term impact of this admission structure on patient outcomes and resident satisfaction. OBJECTIVE: To evaluate the effect of geographic cohorting on patient outcomes and resident satisfaction among inpatient internal medicine teaching services within an academic hospital. DESIGN AND INTERVENTION: We conducted an interrupted time series analysis examining patient outcomes before and after the transition to geographic cohorting of our 3 inpatient teaching services within a 520-bed academic hospital in November 2017. The study observation period spanned from January 2017 to October 2018, allowing for a 2-month run-in period (November-December 2017). PARTICIPANTS: We included patients discharged from the inpatient teaching teams during the study period. We excluded patients admitted to the ICU and observation admissions. MAIN MEASURES: Primary outcome was 6-month mortality adjusted for patient age, sex, race, insurance status, and Charlson Comorbidity Index (CCI) analyzed using a linear mixed effects model. Secondary outcomes included hospital length of stay (LOS), 7-day and 30-day readmission rate, Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores, and resident evaluations of the rotation. KEY RESULTS: During the observation period, 1720 patients (mean age 64, 53% female, 56% white, 62% Medicare-insured, mean CCI 1.57) were eligible for inclusion in the final adjusted model. We did not detect a significant change in 6-month mortality, LOS, and 7-day or 30-day readmission rates. HCAHPS scores remained unchanged (77 to 80% top box, P = 0.19), while resident evaluations of the rotation significantly improved (mean overall score 3.7 to 4.0, P = 0.03). CONCLUSIONS: Geographic cohorting was associated with increased resident satisfaction while achieving comparable patient outcomes to those of traditional hospital admitting models.

Changes in Purchases for Intensive Care Medicines During the COVID-19 Pandemic: A Global Time Series Study.

BACKGROUND: Drug supply disruptions have increased during the COVID-19 pandemic, especially for medicines used in the ICU. Despite reported shortages in wealthy countries, global analyses of ICU drug purchasing during COVID-19 are limited. RESEARCH QUESTION: Has COVID-19 impacted global drug purchases of first-, second-, and third-choice agents used in intensive care? STUDY DESIGN AND METHODS: We conducted a cross-sectional time series study in a global pharmacy sales dataset comprising approximately 60% of the world's population. We analyzed pandemic-related changes in units purchased per 1,000 population for 69 ICU agents. Interventional autoregressive integrated moving average models tested for significant changes when the pandemic was declared (March 2020) and during its first stage from April through August 2020, globally and by development status. RESULTS: Relative to 2019, ICU drug purchases increased by 23.6% (95% CI, 7.9%-37.9%) in March 2020 (P < .001) and then decreased by 10.3% (95% CI, -16.9% to -3.5%) from April through August (P = .006). Purchases for second-choice medicines changed the most, especially in developing countries (eg, 29.3% increase in March 2020). Despite similar relative changes (P = .88), absolute purchasing rates in developing nations remained low. The observed decrease from April through August 2020 was significant only in developed countries (-13.1%; 95% CI, -17.4% to -4.4%; P < .001). Country-level variation seemed unrelated to expected demand and health care infrastructure. INTERPRETATION: Purchases for intensive care medicines increased globally in the month of the COVID-19 pandemic declaration, but before peak infection rates. These changes were most pronounced for second-choice agents, suggesting that inexpensive, generic medicines may be purchased more easily in anticipation of pandemic-related ICU surges. Nevertheless, disparities in access persisted. Trends seemed unrelated to expected demand, and decreased purchasing from April through August 2020 may suggest overbuying. National and international policies are needed to ensure equitable drug purchasing during future pandemics.

An equivalence analysis of provider education in youth mental health care.

OBJECTIVE: To test for equivalence between providers with and without advanced degrees in multiple domains related to delivery of evidence-based treatment. DATA SOURCE: Provider and client data from an effectiveness trial of Alternatives for Families: A Cognitive Behavioral Therapy (AF-CBT) in a major metropolitan area in the United States. STUDY DESIGN: We tested for equivalence between providers (N = 182) with and without advanced degrees in treatment-related knowledge, practices, and attitudes; job demands and stress; and training engagement and trainer-rated competence in AF-CBT. We also conducted exploratory analyses to test for equivalence in family clinical outcomes. DATA COLLECTION: Providers completed measures prior to randomization and at 6-month follow-up, after completion of training and consultation in AF-CBT. Children and caregivers completed assessments at 0, 6, 12, and 18 months. PRINCIPAL FINDINGS: Providers without advanced degrees were largely non-inferior to those with advanced degrees in treatment-related knowledge, practices, and attitudes, while findings for job demands and stress were mixed. Providers without advanced degrees were non-inferior to providers with advanced degrees in consultation attendance (B = -1.42; confidence interval (CI) = -3.01-0.16; margin of equivalence (Δ) = 2), number of case presentations (B = 0.64; CI = -0.49-1.76; Δ = 2), total training hours (B = -4.57; CI = -10.52-1.37; Δ = 3), and trainer-rated competence in AF-CBT (B = -0.04; CI = -3.04-2.96; Δ = 4), and they were significantly more likely to complete training (odds ratio = 0.66; CI = 0.10-0.96; Δ = 30%). Results for clinical outcomes were largely inconclusive. CONCLUSIONS: Provider-level outcomes for those with and without advanced degrees were generally comparable. Additional research is needed to examine equivalence in clinical outcomes. Expanding evidence-based treatment training to individuals without advanced degrees may help to reduce workforce shortages and improve reach of evidence-based treatments.

Chronotype predicts positive affect rhythms measured by ecological momentary assessment.

Evening chronotype, a correlate of delayed circadian rhythms, is associated with depression. Altered positive affect (PA) rhythms may mediate the association between evening chronotype and depression severity. Consequently, a better understanding of the relationship between chronotype and PA may aid in understanding the etiology of depression. Recent studies have found that individuals with evening chronotype show delayed and blunted PA rhythms, although these studies are relatively limited in sample size, representativeness and number of daily affect measures. Further, published studies have not included how sleep timing changes on workday and non-workdays, or social jet lag (SJL) may contribute to the chronotype-PA rhythm link. Healthy non-depressed adults (n = 408) completed self-report affect and chronotype questionnaires. Subsequently, positive and negative affects were measured hourly while awake for at least two workdays and one non-workday by ecological momentary assessment (EMA). Sleep variables were collected via actigraphy and compared across chronotype groups. A cosinor variant of multilevel modeling was used to model individual and chronotype group rhythms and to calculate two variables: (1) amplitude of PA, or the absolute amount of daily variation from peak to trough during one period of the rhythm and (2) acrophase, or the time at which the peak amplitude of affect rhythms occurred. On workdays, individuals with evening chronotype had significantly lower PA amplitudes and later workday acrophase times than their morning type counterparts. In contrast to predictions, SJL was not found to be a mediator in the relationship between chronotype and PA rhythms. The association of chronotype and PA rhythms in healthy adults may suggest the importance of daily measurement of PA in depressed individuals and would be consistent with the hypothesis that evening chronotype may create vulnerability to depression via delayed and blunted PA rhythms.