Nursing Home Characteristics Associated with Antipsychotic Prescribing After Implementation of the National Antipsychotic Reduction Initiative (ARI).

OBJECTIVES: To describe nursing home (NH) characteristics associated with antipsychotic use and test whether associations changed after implementation of the National Partnership to Improve Dementia Care's antipsychotic reduction initiative (ARI). METHODS: Longitudinal quasi-experimental design using data from multiple sources and piecewise linear mixed models were used for statistical analyses. RESULTS: There was a significant decrease in monthly antipsychotic use across the study period (pre-ARI b = -0.0003, p <.001; post-ARI b = -0.0012, p <.001), which held after adjusting for NH characteristics. Registered nurse hours (b = -0.0026, p <.001), licensed practical nurse hours (b = -0.0019, p <.001), facility chain membership (b = -0.0013, p <.01), and health inspection ratings (b = -0.0003, p >.01) were associated with decreased antipsychotic use. Post-ARI changes in associations between NH characteristics and antipsychotic use were small and not statistically significant. CONCLUSIONS: Decreases in antipsychotic use were associated with most NH characteristics, and associations persisted post-ARI. Further research is warranted to examine the interactions between ARI policy and NH characteristics on antipsychotic prescribing, as well as other NH factors, such as facility prescribing cultures and clinical specialty of staff. CLINICAL IMPLICATIONS: Decreases in monthly antipsychotic use were observed following the ARI. The decreases in monthly antipsychotic use were associated with most NH characteristics, and these associations persisted during the post-ARI period.

The effect of tablet computer-based telemonitoring added to an established telephone disease management program on heart failure hospitalizations: The Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) III Randomized Controlled Trial.

BACKGROUND: Mobile health applications are becoming increasingly common. Prior work has demonstrated reduced heart failure (HF) hospitalizations with HF disease management programs; however, few of these programs have used tablet computer-based technology. METHODS: Participants with a diagnosis of HF and at least 1 high risk feature for hospitalization were randomized to either an established telephone-based disease management program or the same disease management program with the addition of remote monitoring of weight, blood pressure, heart rate and symptoms via a tablet computer for 90 days. The primary endpoint was the number of days hospitalized for HF assessed at 90 days. RESULTS: From August 2014 to April 2019, 212 participants from 3 hospitals in Massachusetts were randomized 3:1 to telemonitoring-based HF disease management (n = 159) or telephone-based HF disease management (n = 53) with 98% of individuals in both study groups completing the 90 days of follow-up. There was no significant difference in the number of days hospitalized for HF between the telemonitoring disease management group (0.88 ± 3.28 days per patient-90 days) and the telephone-based disease management group (1.00 ± 2.97 days per patient-90 days); incidence rate ratio 0.82 (95% confidence interval, 0.43-1.58; P = .442). CONCLUSIONS: The addition of tablet-based telemonitoring to an established HF telephone-based disease management program did not reduce HF hospitalizations; however, study power was limited.

Patient Outcomes After Delirium Screening and Incident Alzheimer's Disease or Related Dementias in Skilled Nursing Facilities.

BACKGROUND: The extent to which a positive delirium screening and new diagnosis of Alzheimer's disease or related dementias (ADRD) increases the risk for re-hospitalization, long-term nursing home placement, and death remains unknown. OBJECTIVE: To compare long-term outcomes among newly admitted skilled nursing facility (SNF) patients with delirium, incident ADRD, and both conditions. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study of Medicare beneficiaries who entered a SNF from hospital with a minimum 14-day stay (n = 100,832) from 2015 to 2016. MAIN MEASURES: Return to home, hospital readmission, admission to a long-term care facility, or death. KEY RESULTS: Patients with delirium were as likely to be discharged home as patients diagnosed with ADRD (HR: 0.63, 95% CI: 0.59, 0.67; HR: 0.65, 95% CI: 0.64, 0.67). Patients with both delirium and ADRD were less likely to be discharged home (HR: 0.49, 95% CI: 0.47, 0.52) and showed increased risk of death (HR: 1.30, 95% CI: 1.17, 1.45). Patients with ADRD, regardless of delirium screening status, had increased risk for long-term nursing home care transfer (HR: 1.66, 95% CI: 1.63, 1.70; HR: 1.76, 95% CI: 1.69, 1.82). Patients with delirium and no ADRD showed increased risk of transfer to long-term nursing home care (HR: 1.25, 95% CI: 1.18, 1.33). The rate of deaths was higher among patients who screened positive for delirium without ADRD compared to the no delirium and no ADRD groups (HR: 2.35, 95% CI: 2.11, 2.61). CONCLUSION: A positive delirium screening increased risk of death and transfer to long-term care in the first 100 days after admission regardless of incident ADRD diagnosis. Patients with delirium and/or ADRD also are less likely to be discharged home. Our study builds on the evidence base that delirium is important to address in older adults as it is associated with negative outcomes.

Cycle threshold values and SARS-CoV-2: Relationship to demographic characteristics and disease severity.

Cycle threshold (Ct), or the number of cycles required to amplify viral RNA to a detectable level, provides an estimate of viral load. Previous studies have demonstrated mixed results in regard to the association between SARS-CoV-2 Ct from real-time reverse transcriptase PCR (rRT-PCR) testing to patient outcomes, and there is less data on the relationship between Ct and patient characteristics. This was a retrospective study of 256 patients tested at a tertiary care emergency department from March to July 2020 via nasopharyngeal rRT-PCR testing utilizing the Abbott M2000 SARS-CoV-2 assay. Kruskal-Wallis, univariable, and multivariable logistic regression were used where appropriate for analysis. There were no significant differences in Ct value by demographic characteristics including age, sex, race, or ethnicity. Ct increased with time since symptom onset (p < 0.001), and increasing Ct was associated with increased odds of severe disease (odds ratio: 1.05, 95% confidence interval: 1.0-1.11). Ct was not found to be associated with patient demographic characteristics and increasing Ct was found to be associated with increased odds of severe disease. Continued study will allow us to better comprehend the complex factors that contribute to the risk for severe outcomes due to SARS-CoV-2 infection.

Effect of the 2012 US Preventive Services Task Force Recommendations on Prostate-Specific Antigen Screening in a Medicare Advantage Population.

BACKGROUND: In 2012, the US Preventive Service Task Force revised its recommendations for prostate-specific antigen (PSA) screening from "insufficient evidence" to "do not recommend" for men aged 70-74 while maintaining "do not recommend" for men aged 75+. METHODS: Using the difference-in-difference approach, we evaluated whether the rate of change in the use of low-value PSA screening differed between the control group (men aged 75+, N=7,856,204 person-years) and the intervention group (men aged 70-74, N=5,329,192 person-years) enrolling in the Medicare Advantage plan without a history of prostate cancer within the OptumLabs Data Warehouse claims data (2009-2019). A generalized estimating equation logistic model was specified with independent variables: an intervention group indicator, a pre- and post-period (after 2012 Q2) indicator, index time, and interaction terms. We assumed a 12-month dissemination period. RESULTS: Before the revised recommendation in 2012, the trends did not significantly differ between the 2 age groups with the odds of receiving PSA screening decreasing by 1.2% (95% confidence interval [1.0, 1.4%]) per quarter. However, the odds of receiving PSA screening increased by 3.0% [2.8, 3.2%] per quarter across both groups since the revision. There was no significant additional change in the trend for those aged 70-74 (0.1% [-0.2, 0.5%]). CONCLUSIONS: Although the 2012 US Preventive Service Task Force's recommendations were expected to only change behaviors among men aged 70-74, our analysis found that men aged 70-74 and aged 75+ exhibited similar trends from 2009 to 2019, including the increased use of low-value PSA screening since 2016. Multifaceted efforts to discourage low-value PSA screening would be important for a sustained impact.

Comparative effects of latanoprost and latanoprostene bunod on intraocular pressure and pupil size in ophthalmologically normal Beagle dogs.

OBJECTIVE: To compare effects of latanoprost, a topical prostaglandin analogue (PGA) commonly used to treat glaucoma and lens instability in dogs, and latanoprostene bunod, a novel PGA with a nitric oxide-donating moiety, on intraocular pressure (IOP) and pupil diameter (PD). ANIMALS STUDIED: Ten ophthalmologically normal Beagle dogs. PROCEDURES: Dogs were treated twice a day for 5 days in a randomly selected eye with either latanoprost or latanoprostene bunod. After a 6-week washout period, dogs were treated with the opposite drug. IOP and PD were measured at treatment times, at midday on days 1 and 5, and for 6 days post-treatment. RESULTS: Both drugs significantly decreased IOP and PD. At midday on day 5 of treatment, mean IOP in eyes treated with latanoprost was 4.5 mmHg lower than the fellow eye and 3.0 mmHg lower than the same eye at baseline, while mean IOP in eyes treated with latanoprostene bunod was 5.5 mmHg lower than the fellow eye and 3.6 mmHg lower than baseline. Mean PD was 0.94 mm in eyes treated with latanoprost and 0.76 mmHg in eyes treated with latanoprostene bunod. There was no significant difference between the two drugs for either parameter at that time point (p = .372 and .619, respectively, for IOP relative to control and to baseline; p = .076 for PD) or when analyzed longitudinally. Significant diurnal variation in PD was noted and may have implications for treatment of lens' instability. CONCLUSIONS: Latanoprost and latanoprostene bunod produce similar IOP reduction and miosis in normal canine eyes.

Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke.

Importance: Patent foramen ovale (PFO)-associated strokes comprise approximately 10% of ischemic strokes in adults aged 18 to 60 years. While device closure decreases stroke recurrence risk overall, the best treatment for any individual is often unclear. Objective: To evaluate heterogeneity of treatment effect of PFO closure on stroke recurrence based on previously developed scoring systems. Design, Setting, and Participants: Investigators for the Systematic, Collaborative, PFO Closure Evaluation (SCOPE) Consortium pooled individual patient data from all 6 randomized clinical trials that compared PFO closure plus medical therapy vs medical therapy alone in patients with PFO-associated stroke, and included a total of 3740 participants. The trials were conducted worldwide from 2000 to 2017. Exposures: PFO closure plus medical therapy vs medical therapy alone. Subgroup analyses used the Risk of Paradoxical Embolism (RoPE) Score (a 10-point scoring system in which higher scores reflect younger age and the absence of vascular risk factors) and the PFO-Associated Stroke Causal Likelihood (PASCAL) Classification System, which combines the RoPE Score with high-risk PFO features (either an atrial septal aneurysm or a large-sized shunt) to classify patients into 3 categories of causal relatedness: unlikely, possible, and probable. Main Outcomes and Measures: Ischemic stroke. Results: Over a median follow-up of 57 months (IQR, 24-64), 121 outcomes occurred in 3740 patients. The annualized incidence of stroke with medical therapy was 1.09% (95% CI, 0.88%-1.36%) and with device closure was 0.47% (95% CI, 0.35%-0.65%) (adjusted hazard ratio [HR], 0.41 [95% CI, 0.28-0.60]). The subgroup analyses showed statistically significant interaction effects. Patients with low vs high RoPE Score had HRs of 0.61 (95% CI, 0.37-1.00) and 0.21 (95% CI, 0.11-0.42), respectively (P for interaction = .02). Patients classified as unlikely, possible, and probable using the PASCAL Classification System had HRs of 1.14 (95% CI, 0.53-2.46), 0.38 (95% CI, 0.22-0.65), and 0.10 (95% CI, 0.03-0.35), respectively (P for interaction = .003). The 2-year absolute risk reduction was -0.7% (95% CI, -4.0% to 2.6%), 2.1% (95% CI, 0.6%-3.6%), and 2.1% (95% CI, 0.9%-3.4%) in the unlikely, possible, and probable PASCAL categories, respectively. Device-associated adverse events were generally higher among patients classified as unlikely; the absolute risk increases in atrial fibrillation beyond day 45 after randomization with a device were 4.41% (95% CI, 1.02% to 7.80%), 1.53% (95% CI, 0.33% to 2.72%), and 0.65% (95% CI, -0.41% to 1.71%) in the unlikely, possible, and probable PASCAL categories, respectively. Conclusions and Relevance: Among patients aged 18 to 60 years with PFO-associated stroke, risk reduction for recurrent stroke with device closure varied across groups classified by their probabilities that the stroke was causally related to the PFO. Application of this classification system has the potential to guide individualized decision-making.

Adequacy of Prescription Drug Coverage in Long-term Care.

RESEARCH OBJECTIVE: Affordable access to medications is important to Medicare enrollees in long-term care (LTC), yet, it is unknown if prescription drug coverage is universal and adequate to meet their high medication needs. STUDY DESIGN: We assessed enrollment in prescription drug coverage, out-of-pocket (OOP) payments and medication use in a nationwide LTC database of prescription-level, resident-level, and facility-level data for the period 2011-2013. Inadequate drug coverage was defined as ≥50% medications paid for OOP. Risk-adjusted generalized estimation equations models were estimated to identify predictors of inadequate drug coverage and total prescription fills. POPULATION STUDIED: A nationwide sample of 332,087 Medicare enrollees observed >100 days in LTC. PRINCIPAL FINDINGS: We found Medicare Part D was the main source of drug coverage (82.4%), followed by private insurance (8.5%), and Veterans Administration (0.2%). No drug coverage could be detected for 8.9% (n=29,378) who paid for all of their medications OOP or received only temporary drug payment assistance. Inadequate drug coverage was identified in another 2721 persons. LTC Medicare enrollees without drug coverage or who had private insurance received significantly fewer prescriptions than if they had been enrolled in Medicare Part D. CONCLUSION: A substantial proportion of Medicare enrollees in LTC have inadequate or no drug coverage and are receiving less medication than indicated by their health needs. POLICY IMPLICATIONS: Medicare Part D is an important policy for ensuring affordable access to medications in LTC. However, expansions are needed to increase enrollment and decrease inadequate drug coverage.

Nursing homes underreport antipsychotic prescribing.

Objective: Determine the accuracy of nursing home self-reported antipsychotic prescribing before and after implementation of a Medicare campaign to reduce use.Methods: Quasi-experimental study comparing trends in self-reported antipsychotic prescribing relative to claims-based prescribing. Setting is a nationwide sample of 11,912 facilities, 2011-2013. Participants are long-stay nursing home residents (n = 586,281) with prescribing data in Medicare Minimum Data Set 3.0 and Medicare Part D claims database. Verified with a pharmacy dispensing database. Main outcomes are the discrepancies in quarterly prevalence of antipsychotic prescribing between nursing home self-reports and claims data and the characteristics of facilities and residents where discrepancies were identified.Results: Nursing homes underreport their antipsychotic prescribing levels, on average, by 1 percentage point per quarter relative to Medicare Part D claims (0.013, 95% confidence interval (CI), 0.012-0.015; p<.001). After the Medicare campaign, the underreporting gap increased by another half a percentage point (0.004, 95% CI .003-.005; p = .012). Nursing home residents with dementia, Alzheimer's disease or bipolar disorders were at the highest risk for underreported antipsychotic prescribing before the campaign (Adjusted Odds ratio (AOR) 1.385, 95% CI: 1.330-1.444; AOR 1.234, 95% CI: 1.172-1.300; AOR 1.574, 95% CI: 1.444-1.716, respectively) and afterwards. After the launch of the Medicare campaign, underreported antipsychotic prescribing occurred most in for-profit nursing homes (AOR 1.088, 95% CI: 1.005-1.178) and facilities in the US South (AOR 1.262, 95% CI: 1.145-1.391). Agreement was high between claims and dispensing data (99.7%).Conclusion: Nursing homes did not identify up to 6,000 residents per calendar quarter as having received antipsychotics despite these prescriptions being paid by Medicare and dispensed by a pharmacy. Nursing home rates of antipsychotic prescribing from self-reported data may be biased.

Measuring job satisfaction among healthcare staff in the United States: a confirmatory factor analysis of the Satisfaction of Employees in Health Care (SEHC) survey.

OBJECTIVE: To validate the Satisfaction of Employees in Health Care (SEHC) survey with multidisciplinary, healthcare staff in the United States (U.S.). DESIGN: A cross-sectional psychometric study using confirmatory factor analysis. The original three-factor model was tested and modified using half-samples. Models were assessed using goodness-of-fit measures. Scale reliability and validity were tested with Cronbach's α coefficient and correlation of total SEHC score with two global satisfaction items, respectively. SETTING: We administered a web-based survey from January to May 2015 to healthcare staff participating in initiatives aimed at delivering better care and reducing costs. PARTICIPANTS: The overall response rate was 38% (N = 1089), and respondents were from 86 healthcare projects. A total of 928 respondents completed the SEHC survey in full and were used in this study. MAIN OUTCOME MEASURES: Model fit of 18 SEHC items and total SEHC score. RESULTS: The mean SEHC score was 77.6 (SD: 19.0). A one-factor model of job satisfaction had high loadings on all items, and demonstrated adequate model fit (second half-sample RMSEA: 0.069). The scale demonstrated high reliability (Cronbach's alpha = 0.942) and validity (r = 0.77 and 0.76, both P < 0.05). CONCLUSIONS: The SEHC appears to measure a single general job satisfaction construct. The scale has adequate reliability and validity to recommend its use to assess satisfaction among multidisciplinary, U.S. healthcare staff. Our findings suggest that this survey is a good candidate for reduction to a short-form, and future research should validate this survey in other healthcare populations.

Can Surgeons Reliably Identify Non-cirrhotic Liver Disease During Laparoscopic Bariatric Surgery?

INTRODUCTION: Identification of liver disease during bariatric operations is an important task given the patients risk for occult fatty liver disease. Surgeon's accuracy of assessing for liver disease during an operation is poorly understood. The objective was to measure surgeons' performance on intra-operative visual assessment of the liver in a simulated environment. METHODS: Liver images from 100 patients who underwent laparoscopic bariatric surgery and pre-operative ultrasound elastography between July 2020 and July 2021 were retrospectively evaluated. The perception of 15 surgeons regarding the degree of hepatic steatosis and fibrosis was collected in a simulated clinical environment by survey and compared to results determined by ultrasonographic exam. RESULTS: The surgeons' ability to correctly identify the class of steatosis and fibrosis was poor (accuracy 61% and 59%, respectively) with a very weak correlation between the surgeon's predicted class and its true class (r = 0.17 and r = 0.12, respectively). When liver disease was present, surgeons completely missed its presence in 26% and 51% of steatosis and fibrosis, respectively. Digital image processing demonstrated that surgeons subjectively classified steatosis based on the "yellowness" of the liver and fibrosis based on texture of the liver, despite neither correlating with the true degree of liver disease. CONCLUSION: Laparoscopic visual assessment of the liver surface for identification of non-cirrhotic liver disease was found to be an inaccurate method during laparoscopic bariatric surgery. While validation studies are needed, the results suggest the clinical need for alternative approaches.

Atherosclerotic Cardiovascular Disease Risk and Longitudinal Risk Factor Management Among Patients With Breast Cancer.

BACKGROUND: Cardiovascular disease is the leading cause of noncancer mortality for breast cancer survivors. Data are limited regarding patient-level atherosclerotic cardiovascular disease (ASCVD) risk estimation and preventive medication use. This study aimed to characterize ASCVD risk and longitudinal preventive medication use for a cohort of patients with nonmetastatic breast cancer. PATIENTS AND METHODS: This retrospective cohort study included 326 patients at an academic medical center in Boston, Massachusetts diagnosed with nonmetastatic breast cancer or ductal carcinoma in situ from January 2009 through December 2015. Patient demographics, clinical characteristics, laboratory studies, medication exposure, and incident cardiovascular outcomes were collected. Estimated 10-year ASCVD risk was calculated for all patients from nonlaboratory clinical parameters. RESULTS: Median follow up time was 6.5 years (IQR 5.0, 8.1). At cancer diagnosis, 23 patients (7.1%) had established ASCVD. Among those without ASCVD, 10-year estimated ASCVD risk was ≥20% for 77 patients (25.4%) and 7.5% to <20% for 114 patients (37.6%). Two-hundred and sixteen patients (66.3%) had an indication for lipid-lowering therapy at cancer diagnosis, 123 of whom (57.0%) received a statin during the study. Among 100 patients with ASCVD or estimated 10-year ASCVD risk ≥20%, 92 (92.0%) received an antihypertensive medication during the study. Clinic blood pressure >140/90 mmHg was observed in 33.0% to 55.6% of these patients at each follow up assessment. CONCLUSION: A majority of patients in this breast cancer cohort had an elevated risk of ASCVD at the time of cancer diagnosis. Modifiable ASCVD risk factors were frequently untreated or uncontrolled in the years following cancer treatment.

Relationship Between Genotype Status and Clinical Outcome in Hypertrophic Cardiomyopathy.

BACKGROUND: The genetic basis of hypertrophic cardiomyopathy (HCM) is complex, and the relationship between genotype status and clinical outcome is incompletely resolved. METHODS AND RESULTS: We assessed a large international HCM cohort to define in contemporary terms natural history and clinical consequences of genotype. Consecutive patients (n=1468) with established HCM diagnosis underwent genetic testing. Patients with pathogenic (or likely pathogenic) variants were considered genotype positive (G+; n=312; 21%); those without definite disease-causing mutations (n=651; 44%) or variants of uncertain significance (n=505; 35%) were considered genotype negative (G-). Patients were followed up for a median of 7.8 years (interquartile range, 3.5-13.4 years); HCM end points were examined by cumulative event incidence. Over follow-up, 135 (9%) patients died, 33 from a variety of HCM-related causes. After adjusting for age, all-cause and HCM-related mortality did not differ between G- versus G+ patients (hazard ratio [HR], 0.78 [95% CI, 0.46-1.31]; P=0.37; HR, 0.93 [95% CI, 0.38-2.30]; P=0.87, respectively). Adverse event rates, including heart failure progression to class III/IV, heart transplant, or heart failure death, did not differ (G- versus G+) when adjusted for age (HR, 1.20 [95% CI, 0.63-2.26]; P=0.58), nor was genotype independently associated with sudden death event risk (HR, 1.39 [95% CI, 0.88-2.21]; P=0.16). In multivariable analysis, age was the only independent predictor of all-cause and HCM-related mortality, heart failure progression, and sudden death events. CONCLUSIONS: In this large consecutive cohort of patients with HCM, genotype (G+ or G-) was not a predictor of clinical course, including all-cause and HCM-related mortality and risk for heart failure progression or sudden death. G+ status should not be used to dictate clinical management or predict outcome in HCM.

Patent Foramen Ovale Closure in Older Patients With Stroke: Patient Selection for Trial Feasibility.

BACKGROUND AND OBJECTIVES: Whether patent foramen ovale (PFO) closure benefits older patients with PFO and cryptogenic stroke is unknown because randomized controlled trials (RCTs) have predominantly enrolled patients younger than 60 years of age. Our objective was to estimate anticipated effects of PFO closure in older patients to predict the numbers needed to plan an RCT. METHODS: Effectiveness estimates are derived from major observational studies (Risk of Paradoxical Embolism [RoPE] Study and Oxford Vascular Study, together referred to as the "RoPE-Ox" database) and all 6 major RCTs (Systematic, Collaborative, PFO Closure Evaluation [SCOPE] Consortium). To estimate stroke recurrence risk, observed outcomes were calculated for patients older than 60 years in the age-inclusive observational databases (n = 549). To estimate the reduction in the rate of recurrent stroke associated with PFO closure vs medical therapy based on the RoPE score and the presence of high-risk PFO features, a Cox proportional hazards regression model was developed on the RCT data in the SCOPE database (n = 3,740). These estimates were used to calculate sample sizes required for a future RCT. RESULTS: Five-year risk of stroke recurrence using Kaplan-Meier estimates was 13.7 (95% CI 10.5-17.9) overall, 14.9% (95% CI 10.2-21.6) in those with high-risk PFO features. Predicted relative reduction in the event rate with PFO closure was 12.9% overall, 48.8% in those with a high-risk PFO feature. Using these estimates, enrolling all older patients with cryptogenic stroke and PFO would require much larger samples than those used for prior PFO closure trials, but selectively enrolling patients with high-risk PFO features would require totals of 630 patients for 90% power and 471 patients for 80% power, with an average of 5 years of follow-up. DISCUSSION: Based on our projections, anticipated effect sizes in older patients with high-risk features make a trial in these subjects feasible. With lengthening life expectancy in almost all regions of the world, the utility of PFO closure in older adults is increasingly important to explore.

The impact of external reference pricing on pharmaceutical costs and market dynamics.

Growth in the cost of prescription drugs in the US has generated significant interest in the use of external reference pricing (ERP) to tie prices paid for drugs to those in other countries. We used data from the Pricentric ONE™ database, an international drug pricing database, to examine product launch timing, launch price, and price changes from January 2010 - October 2021 in both ERP and non-ERP settings, with a focus on 100 high-priced drugs of interest to Medicare and Medicaid. We found that ERP policies were associated with a 73% reduction in the likelihood of drug launch within 9 months of regulatory approval relative to non-ERP settings. In addition, while ERP was associated with statistically significant reductions in annual drug price changes, such policies did not impact launch price. In addition, no single ERP feature (e.g., number of countries referenced, ERP calculation) was materially associated with the outcomes of interest. We conclude that ERP policies do not appear to impact drug launch price and may delay access to new therapies, raising questions about the utility of such policies in the US and potential consequences abroad.

Rapid resolution of hyperfibrinolysis in dogs with spontaneous hemoperitoneum following surgical control of hemorrhage.

OBJECTIVE: To estimate the point prevalence and duration of hyperfibrinolysis (HF) in dogs undergoing surgical control of spontaneous hemoperitoneum (SHP). DESIGN: Prospective observational study. SETTING: Single veterinary teaching hospital. ANIMALS: Forty-five client-owned dogs with SHP were screened for HF. Eighteen HF dogs treated surgically were studied. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Dogs with SHP and evidence of shock admitted for surgical control of hemorrhage were screened for HF. Blood samples were collected for PCV, total plasma protein, platelet count, and thromboelastography with 50 U/mL of tissue plasminogen activator at presentation and every 8 hours postoperatively until 72 hours, discharge, or death. HF was defined as a tissue plasminogen activator-activated thromboelastography lysis percentage measured 30 minutes after maximum amplitude (LY30) of ≥20%. LY30 values were compared to a cohort of samples obtained from healthy dogs (n = 22). The point prevalence of HF in all dogs screened was 40% (18/45 dogs), and the mean LY30 at baseline for HF dogs was 48.9% (±24.2%), which was significantly higher than that of control dogs (4.8% ± 7.1%, P < 0.001) and non-HF dogs (1.9% ± 5.7%, P < 0.001). In HF dogs, there was a significant decrease in LY30 between baseline and 8 hours (P < 0.0001) and between 8 and 16 hours (P = 0.035) but no significant change thereafter. LY30 at 8 hours (4%, range: 0%-23.4%) was not statistically different from control dogs (6.5%, range: 1.2%-32.8%, P = 0.664) suggesting early resolution of HF in this population. Only 2 of 18 dogs were persistently hyperfibrinolytic at 24 hours. Malignancy was diagnosed in 12 of 18 dogs (66.6%), while a benign etiology occurred in 6 of 18 dogs (33.3%). All HF dogs survived to discharge. CONCLUSIONS: HF occurs in some dogs with hypovolemic shock due to hemoperitoneum but resolves rapidly following surgical control of bleeding without antifibrinolytic medications. Routine postoperative use of antifibrinolytics in dogs with hemoperitoneum in dogs undergoing surgical control of bleeding may not be warranted.

Left ventricular stroke volume index following transcatheter aortic valve replacement is an early predictor of 1-year survival.

BACKGROUND: Adverse cardiac events are common following transcatheter aortic valve replacement (TAVR). Our aim was to investigate the low left ventricular stroke volume index (LVSVI) 30 days after TAVR as an early echocardiographic marker of survival. HYPOTHESIS: Steady-state (30-day) LVSVI after TAVR is associated with 1-year mortality. METHODS: A single-center retrospective analysis of all patients undergoing TAVR from 2017 to 2019. Baseline and 30-day post-TAVR echocardiographic LVSVI were calculated. Patients were stratified by pre-TAVR transaortic gradient, surgical risk, and change in transvalvular flow following TAVR. RESULTS: This analysis focuses on 238 patients treated with TAVR. The 1-year mortality rate was 9% and 124 (52%) patients had normal flow post-TAVR. Of those with pre-TAVR low flow, 67% of patients did not normalize LVSVI at 30 days. The 30-day normal flow was associated with lower 1-year mortality when compared to low flow (4% vs. 14%, p = .007). This association remained significant after adjusting for known predictors of risk (adjusted odds ratio [OR] of 3.45, 95% confidence interval: 1.02-11.63 [per 1 ml/m2 decrease], p = .046). Normalized transvalvular flow following TAVR was associated with reduced mortality (8%) when compared to those with persistent (15%) or new-onset low flow (12%) (p = .01). CONCLUSIONS: LVSVI at 30 days following TAVR is an early echocardiographic predictor of 1-year mortality and identifies patients with worse intermediate outcomes. More work is needed to understand if this short-term imaging marker might represent a novel therapeutic target.

Preventing lost-to-follow up diagnostic imaging in ambulatory care: evaluation of an electronic notification tool.

OBJECTIVE: Missed or cancelled imaging tests may be invisible to the ordering clinician and result in diagnostic delay. We developed an outpatient results notification tool (ORNT) to alert physicians of patients' missed radiology studies. DESIGN: Randomised controlled evaluation of a quality improvement intervention. SETTING: 23 primary care and subspecialty ambulatory clinics at an urban academic medical centre. PARTICIPANTS: 276 physicians randomised to intervention or usual care. MAIN OUTCOME MEASURE: 90-day test completion of missed imaging tests. RESULTS: We included 3675 radiology tests in our analysis: 1769 ordered in the intervention group and 1906 in the usual care group. A higher per cent of studies were completed for intervention compared with usual care groups in CT (20.7% vs 15.3%, p=0.06), general radiology (19.6% vs 12.0%, p=0.02) and, in aggregate, across all modalities (18.1% vs 16.1%, p=0.03). In the multivariable regression model adjusting for sex, age and insurance type and accounting for clustering with random effects at the level of the physician, the intervention group had a 36% greater odds of test completion than the usual care group (OR: 1.36 (1.097-1.682), p=0.005). In the Cox regression model, patients in the intervention group were 1.32 times more likely to complete their test in a timely fashion (HR: 1.32 (1.10-1.58), p=0.003). CONCLUSIONS: An electronic alert that notified the responsible clinician of a missed imaging test ordered in an ambulatory clinic reduced the number of incomplete tests at 90 days. Further study of the obstacles to completing recommended diagnostic testing may allow for the development of better tools to support busy clinicians and their patients and reduce the risk of diagnostic delays.