Novel in-home COVID-19 vaccination program for vulnerable populations using public-private collaboration.

Background: The continued emergence of new COVID-19 variants highlights the importance of vaccination in the effort to reduce disease transmission and burden. The objective of this study is to evaluate the processes and outcomes associated with a novel in-home COVID-19 vaccination program aimed at vaccinating high-risk populations in New York, USA. Methods: To evaluate program processes, we described the program itself and reflected on some key lessons learned. To evaluate program outcomes, we analyzed data reported by vaccine recipients. These outcomes included the percentage of vaccine recipients that successfully received the full course of vaccinations, and the demographic and health characteristics of vaccine recipients. We additionally assessed demographic differences in motivations for receiving in-home care, using chi-squared tests to assess statistical significance. Data were collected and reported via dynamic online intake forms. Results: The median age of vaccine recipients was 79 ± SD 9.0 years. The oldest vaccine recipient was 107 years old. Of those with non-missing data, more than half of vaccine recipients were female (63%), identified as part of a racial/ethnic minority (66%), reported an annual income of < $25,000 (58%), and received a high school degree or less (68%). Most vaccine recipients reported having one or more health conditions associated with increased risk of severe COVID-19 disease (72%). Vaccine recipients were most likely to report receiving in-home vaccination because they were home-bound due to disability. Motivations for receiving in-home vaccination differed by demographic subgroup. Conclusion: The population receiving vaccinations from this in-home care delivery program comprised seniors who were mostly female and non-white, indicated socioeconomic vulnerability, and reported one or more COVID-related health conditions; this signified that the program met its goal of vaccinating those most at risk for severe COVID-19 disease.

Correction: Evaluating the Quality of Asynchronous Versus Synchronous Virtual Care in Patients With Erectile Dysfunction: Retrospective Cohort Study.

[This corrects the article DOI: 10.2196/32126.].

Evaluating the Quality of Asynchronous Versus Synchronous Virtual Care in Patients With Erectile Dysfunction: Retrospective Cohort Study.

BACKGROUND: Asynchronous health care encounters are becoming an increasingly mainstream form of telehealth. While synchronous phone or video visits have become more widely accepted, US policymakers and other key health care stakeholders have been hesitant to fully embrace asynchronous diagnosis and treatment. This is particularly true in the context of direct-to-consumer (DTC) platforms, where encounters are patient-initiated and there is no preestablished relationship with a provider. This hesitation is compounded by limited research comparing outcomes between asynchronous and synchronous care, especially in the DTC context. OBJECTIVE: The purpose of this study was to explore whether asynchronous care leads to different patient outcomes in the form of medication-related adverse events when compared to synchronous virtual care. METHODS: Using 10,000 randomly sampled patient records from a prominent US-based DTC platform, we analyzed the rates of patient-reported side effects from commonly prescribed erectile dysfunction medications and compared these rates across modalities of treatment. RESULTS: Asynchronous care resulted in lower but nonsignificant differences in the rates of the reported drug-related side effects compared to synchronous treatment. CONCLUSIONS: In some circumstances, such as treatment for erectile dysfunction, asynchronous care can offer the same level of safety in prescribing when compared to synchronous care. More research is needed to evaluate the safety of asynchronous care across a wider set of conditions and measures.

Pregnancy rates and outcomes in women with and without MS in the United States.

OBJECTIVE: To compare pregnancy prevalence and complications in women with and without multiple sclerosis (MS). METHODS: This retrospective US administrative claims study used data from January 1, 2006, to June 30, 2015. All data for women with MS were included. A nationally representative 5% random sample from approximately 58 million women without MS was used to compute the dataset. Annual pregnancy rates, identified via diagnosis/procedure codes and adjusted for covariates, were estimated via logistic regression. Claims for pregnancy and labor/delivery complications were compared using propensity score matching. RESULTS: From 2006 to 2014, the adjusted proportion of women with MS and pregnancy increased from 7.91% to 9.47%; the adjusted proportion without MS and with pregnancy decreased from 8.83% to 7.75%. The difference in linear trend (0.17% increase and 0.15% decrease in per-annum pregnancy rates) was significant (t statistic = 7.8; p < 0.0001). After matching (n = 2,115 per group), a higher proportion of women with MS than without had claims for premature labor (31.4% vs 27.4%; p = 0.005), infection (13.3% vs 10.9%; p = 0.016), cardiovascular disease (3.0% vs 1.9%; p = 0.028), anemia/acquired coagulation disorders (2.5% vs 1.3%; p = 0.007), neurologic complications (1.6% vs 0.6%; p = 0.005), sexually transmitted diseases (0.4% vs 0.1%; p = 0.045), acquired fetal damage (27.8% vs 23.5%; p = 0.002), and congenital fetal malformations (13.2% vs 10.3%; p = 0.004). CONCLUSIONS: Pregnancy rates in this population of women with MS have been increasing. High rates of claims for several peripartum complications were observed in women with and those without MS. Claims data provide knowledge of interactions patients have with the health care system and are valuable initial exploratory analyses.

Ezetimibe Use and LDL-C Goal Achievement: A Retrospective Database Analysis of Patients with Clinical Atherosclerotic Cardiovascular Disease or Probable Heterozygous Familial Hypercholesterolemia.

BACKGROUND: Ezetimibe is recommended by clinical practice guidelines as a second-line therapy for lowering low-density lipoprotein cholesterol (LDL-C) levels, but little is known about its use and effectiveness in real-world populations. OBJECTIVE: To understand the real-world impact of adding or switching to ezetimibe on LDL-C goal achievement in patients with clinical atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH). METHODS: Patients aged ≥ 18 years with an LDL-C measurement available between January 1, 2013, and June 30, 2014, were identified using the Inovalon MORE 2 database; this included commercial, health insurance exchange, Medicare Advantage, and managed Medicaid patients. The index date was the date of the first LDL-C measurement. Patients were required to have evidence of clinical ASCVD or probable HeFH based on ICD-9-CM codes and ≥ 1 outpatient pharmacy claim for a statin in the 1-year pre-index period, as well as continuous medical and pharmacy coverage for 1 year pre- and post-index. Patients who added ezetimibe to existing statin therapy or switched to ezetimibe within 90 days post-index LDL-C measurement were identified in order to replicate the typical time a clinician takes to assess the use of ezetimibe. The primary outcome was the proportion of patients who met the LDL-C goal of < 70 mg/dL within the follow-up period. LDL-C goal achievement was evaluated by baseline LDL-C level groupings: < 70 mg/dL, 70-99 mg/dL, 100-129 mg/dL, or ≥ 130 mg/dL; and across 4 patient diagnosis categories: all patients, ASCVD only, probable HeFH only, and ASCVD and probable HeFH. Descriptive analyses were reported. Categorical variables were summarized as the number of and corresponding percentage of patients. Continuous variables were presented as the mean and SD of the number of observations and median and range where appropriate. RESULTS: Of 125,330 patients who met selection criteria, mean age was 70.1 (SD = 9.9) years and mean LDL-C baseline was 90.7 (SD = 34.0) mg/dL. Over one half of patients (70%) were receiving statin therapy. Within the post-index time frame, 1.05% (n = 1,309) of patients added or switched to ezetimibe. Of these, 26% achieved LDL-C goal during the 90-day follow-up (59.5% did not achieve goal and 14.4% did not have a follow-up lab value). Therapeutic targets were reached by 30% of patients with baseline LDL-C levels of 70-99 mg/dL; 14% of those with baseline LDL-C of 100-129 mg/dL; and 7% of those with baseline LDL-C of ≥ 130 mg/dL. Achievement of LDL-C goals also varied by baseline diagnosis category. CONCLUSIONS: The addition of or switch to ezetimibe therapy was associated with a relatively small percentage of LDL-C goal achievement (< 70 mg/dL) in patients with clinical ASCVD and/or HeFH, even among patients with baseline LDL-C between 70 and 99 mg/dL. To provide superior individualized care for patients with hyperlipidemia, there is a potential role for newer therapies in lipid lowering, such as PCSK9 inhibitors, in appropriate high-risk populations. DISCLOSURES: This study was sponsored by Amgen. Menzin, Yu, and Stern are employees of Boston Health Economics, which was contracted by Amgen to perform this study. Aggarwal is a former employee of Boston Health Economics. Boatman, Patel, and Harrison are employees and stockholders of Amgen. Study concept and design were contributed by Menzin, Aggarwal, Harrison, and Patel. Aggarwal, Stern, and Yu collected the data. Data interpretation was performed by Aggarwal, Harrison, Patel, and Boatman. The manuscript was written and revised primarily by Aggarwal, with assistance from the other authors.