Factors influencing support for the implementation of community-based out-of-hospital cardiac arrest interventions in high- and low-performing counties.

Aim of the study: Survival to hospital discharge from out-of-hospital cardiac arrest (OHCA) after receiving treatment from emergency medical services (EMS) is less than 10% in the United States. Community-focused interventions improve survival rates, but there is limited information on how to gain support for new interventions or program activities within these populations. Using data from the RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial, we aimed to identify the factors influencing emergency response agencies' support in implementing an OHCA intervention. Methods: North Carolina counties were stratified into high-performing or low-performing counties based on the county's cardiac arrest volume, percent of bystander-cardiopulmonary resuscitation (CPR) performed, patient survival to hospital discharge, cerebral performance in patients after cardiac arrest, and perceived engagement in the RACE-CARS project. We randomly selected 4 high-performing and 3 low-performing counties and conducted semi-structured qualitative interviews with emergency response stakeholders in each county. Results: From 10/2021 to 02/2022, we completed 29 interviews across the 7 counties (EMS (n = 9), telecommunications (n = 7), fire/first responders (n = 7), and hospital representatives (n = 6)). We identified three themes salient to community support for OHCA intervention: (1) initiating support at emergency response agencies; (2) obtaining support from emergency response agency staff (senior leadership and emergency response teams); and (3) and maintaining support. For each theme, we described similarities and differences by high- and low-performing county. Conclusions: We identified techniques for supporting effective engagement of emergency response agencies in community-based interventions for OHCA improving survival rates. This work may inform future programs and initiatives around implementation of community-based interventions for OHCA.

Improving Guideline-Directed Medical Therapy for Patients With Heart Failure With Reduced Ejection Fraction: A Review of Implementation Strategies.

Despite recent advances in the use of guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF), achievement of target GDMT use and up-titration to goal dosages continue to be modest. In recent years, a number of interventional approaches to improve the usage of GDMT have been published, but many are limited by single-center experiences with small sample sizes. However, strategies including the use of multidisciplinary teams, dedicated GDMT titration algorithms and clinician audits with feedback have shown promise. There remains a critical need for large, rigorous trials to assess the utility of differing interventions to improve the use and titration of GDMT in HFrEF. Here, we review existing literature in GDMT implementation for those with HFrEF and discuss future directions and considerations in the field.

Risk of pre-term birth as a function of sleep quality and obesity: prospective analysis in a large Prematurity Research Cohort.

Study Objective: To investigate whether poor sleep quality is associated with pre-term birth (PTB) risk, overall and independent of sleep apnea and habitual snoring. Methods: We used longitudinal data from the Washington University Prematurity Research Cohort to investigate the association between poor sleep quality (defined as a Pittsburgh Sleep Quality Index > 5) and PTB, overall and independent of sleep apnea and snoring (defined by the Berlin questionnaire and prior sleep clinic attendance). Associations were investigated for sleep quality early and throughout pregnancy. Stratified analyses were performed by factors previously shown to modify associations between sleep and PTB (race, pre-pregnancy obesity). Results: Of the 976 eligible participants, 50.1% experienced poor sleep quality early in pregnancy (<20 completed weeks) and 14.2% delivered pre-term (n = 50 without and 89 with poor sleep quality). In multivariable-adjusted analyses, poor sleep quality early in pregnancy was associated with increased PTB risk (hazard ratio [HR] = 1.48, 95% confidence interval [CI] = 1.02-2.14). This association persisted after further adjustment for sleep apnea and snoring (HR = 1.50, 95% CI = 1.02-2.20) and in analyses stratified by race. It varied, however, by pre-pregnancy obesity. Among individuals without obesity, no association was observed between poor sleep and PTB (HR = 1.08, 95% CI = 0.65-1.79), whereas among those with obesity, a positive association was observed (HR = 2.94, 95% CI = 1.52-5.69, p-interaction = .05). This association was limited to individuals with obesity who experienced poor sleep both earlier and later in pregnancy (HR = 3.94, 95% CI = 1.56-9.99). Conclusion: Our findings suggest that improving sleep quality early in pregnancy may be important for PTB prevention, particularly among individuals with obesity.

Efficacy of Postpartum Pharmacologic Thromboprophylaxis: A Systematic Review and Meta-analysis.

OBJECTIVE: To evaluate the effectiveness of pharmacologic venous thromboembolism (VTE) prophylaxis in postpartum patients. DATA SOURCES: On February 21, 2022, a literature search was conducted on Embase.com , Ovid-Medline All, Cochrane Library, Scopus, and ClinicalTrials.gov using terms postpartum period AND thromboprophylaxis AND antithrombin medications including heparin and low molecular weight heparin. METHODS OF STUDY SELECTION: Studies that evaluated the outcome of VTE among postpartum patients exposed to pharmacologic VTE prophylaxis with or without a comparator group were eligible for inclusion. Studies of patients who received antepartum VTE prophylaxis, studies in which this prophylaxis could not be definitively ruled out, and studies of patients who received therapeutic dosing of anticoagulation for specific medical problems or treatment of VTE were excluded. Titles and abstracts were independently screened by two authors. Relevant full-text articles were retrieved and independently reviewed for inclusion or exclusion by two authors. TABULATION, INTEGRATION, AND RESULTS: A total of 944 studies were screened by title and abstract, and 54 full-text studies were retrieved for further evaluation after 890 studies were excluded. Fourteen studies including 11,944 patients were analyzed: eight randomized controlled trials (8,001 patients) and six observational studies (3,943 patients). Among the eight studies with a comparator group, there was no difference in the risk of VTE between patients who were exposed to postpartum pharmacologic VTE prophylaxis and those who were unexposed (pooled relative risk 1.02, 95% CI 0.29-3.51); however, six of eight studies had no events in either the exposed or unexposed group. Among the six studies without a comparator group, the pooled proportion of postpartum VTE events was 0.00, likely due to five of six studies having no events. CONCLUSION: The current literature provided an insufficient sample size to conclude whether postpartum VTE rates differ between those exposed to postpartum pharmacologic prophylaxis and those unexposed, given the rarity of VTE events. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022323841.

Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study.

BACKGROUND: Suboptimal medication adherence is a significant problem for patients with serious mental illness. Measuring medication adherence through subjective and objective measures can be challenging, time-consuming, and inaccurate. OBJECTIVE: The primary purpose of this feasibility and acceptability study was to evaluate the impact of a digital medicine system (DMS) among Veterans (patients) with serious mental illness as compared with treatment as usual (TAU) on medication adherence. METHODS: This open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semistructured interviews with patients and providers were used to examine the feasibility and acceptability of using the DMS. RESULTS: We enrolled 46 patients across 2 Veterans Health Administration sites: 21 (46%) in DMS and 25 (54%) in TAU. There was no difference in the proportion of days covered by medication refill over 3 and 6 months (0.82, SD 0.24 and 0.75, SD 0.26 in DMS vs 0.86, SD 0.19 and 0.82, SD 0.21 in TAU, respectively). The DMS arm had 0.85 (SD 0.20) proportion of days covered during the period they were engaged with the DMS (mean 144, SD 100 days). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient findings described the positive impact of the DMS on medication adherence, challenges with the DMS patch connectivity and skin irritation, and challenges with the DMS app that affected overall use. Providers described an overall interest in using a DMS as an objective measure to support medication adherence in their patients. However, providers described challenges with the DMS dashboard and integrating DMS data into their workflow, which decreased the usability of the DMS for providers. CONCLUSIONS: There was no observed difference in refill rates. Among those who engaged in the DMS arm, the proportion of days covered by refills were relatively high (mean 0.85, SD 0.20). The qualitative analyses highlighted areas for further refinement of the DMS. TRIAL REGISTRATION: ClinicalTrials.gov NCT03881449; https://clinicaltrials.gov/ct2/show/NCT03881449.

Simplifying the prediction of vaginal birth after cesarean delivery: role of the cervical exam.

OBJECTIVE: Predicting likelihood of vaginal birth after cesarean (VBAC) is a cornerstone in counseling patients considering a trial of labor after cesarean (TOLAC). Yet, the simplified Bishop score (SBS), a score comprised cervical dilation, station, and effacement assessment used to predict successful vaginal delivery, has not been applied to the TOLAC population. We evaluated the relationship between admission SBS and likelihood of successful VBAC. We also determined the predictive characteristics of SBS, compared to cervical dilation alone, for successful VBAC. METHODS: This is a secondary analysis of a prospective cohort study of patients with a singleton gestation, ≥37 0/7 weeks gestation, and prior cesarean admitted to Labor & Delivery between 2010 and 2014. The primary outcome of successful VBAC was compared between those with a favorable (score >5) and unfavorable (score ≤5) admission SBS. Secondary outcomes were select maternal and neonatal outcomes. Adjusted risk ratios were estimated using multivariable logistic regression analyses. Receiver-operating characteristic curves compared predictive capabilities of cervical dilation alone to SBS for successful VBAC. RESULTS: Of the 656 patients who underwent a TOLAC during the study period, 421 (64%) had a successful VBAC. 203 (31%) and 453 (69%) had a favorable and an unfavorable admission SBS, respectively. After adjusting for body mass index and prior vaginal delivery, patients with a favorable admission SBS had a 30% greater likelihood of successful VBAC compared to those with an unfavorable SBS (aRR 1.30, 95% CI 1.16-1.40). Admission cervical dilation alone performed similarly to SBS as a predictor of successful VBAC, with a receiver-operator characteristic curve area under the curve (AUC) of 0.68 (95% CI 0.64-0.72) versus an AUC 0.66 (95% CI 0.62-0.70), respectively (p = .07). There were no differences in adverse maternal or neonatal outcomes between those with an unfavorable and favorable SBS. CONCLUSIONS: A favorable admission SBS is associated with an increased likelihood of VBAC. Although both admission SBS and cervical dilation alone are only modest predictors of VBAC, admission cervical dilation performs overall similarly to current models for VBAC prediction and is an objective, reproducible, and generalizable measure. Our study highlights the value of waiting until end of pregnancy (rather than the first prenatal visit) to conclude patient counseling on the decision to TOLAC in order to consider admission cervical assessment, particularly cervical dilation.

Factors Related to Biologic Adherence and Outcomes Among Moderate-to-Severe Asthma Patients.

BACKGROUND: Adherence barriers to asthma biologics may not be uniform across administration settings for patients with moderate-to-severe asthma. OBJECTIVE: To examine differences in asthma biologic adherence and associated factors, as well as association with a 1-year all-cause emergency department (ED) visit, across administration settings. METHODS: A retrospective study of biologic naïve moderate-to-severe asthma patients with initial biologic therapy between January 1, 2016, and April 30, 2020, in the Optum Clinformatics Data Mart was performed. Three administration settings were identified: Clinic-only (outpatient office/infusion center), Home (self-administration), and Hybrid setting (mixture of clinic and self-administration). Asthma biologic adherence was the proportion of observed over expected biologic dose administrations received within 6 months from initial therapy. Factors associated with adherence were identified by administration setting, using Poisson regression analyses. A relationship between a 1-year all-cause ED visit and adherence was assessed for each administration setting using Cox regression analyses. RESULTS: The study cohort was 3932 patients. Biologics adherence was 0.75 [0.5, 1] in Clinic setting, the most common administration setting, and 0.83 [0.5, 1] in both Home and Hybrid settings. Specialist access was consistently associated with better biologic adherence, whereas Black race, Hispanic ethnicity, lower education, Medicare only insurance, and higher patient out-of-pocket cost were associated with worse biologic adherence in some settings. In the Hybrid setting, hazard for a 1-year all-cause ED visit decreased with biologic adherence. CONCLUSIONS: Asthma biologic adherence varied by administration setting. Efforts to improve asthma biologic adherence should consider promoting self-administration when beneficial, improving prior specialist access, and targeting patients with higher risk of suboptimal adherence particularly Black and Hispanic patients.

Patients' Experiences With Staphylococcus aureus and Gram-Negative Bacterial Bloodstream Infections: Results From Cognitive Interviews to Inform Assessment of Health-Related Quality of Life.

BACKGROUND: We previously conducted a concept elicitation study on the impact of Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) on health-related quality of life (HRQoL) from the patient's perspective and found significant impacts on HRQoL, particularly in the physical and functional domains. Using this information and following guidance on the development of patient-reported outcome (PRO) measures, we determined which combination of measures and items (ie, specific questions) would be most appropriate in a survey assessing HRQoL in bloodstream infections. METHODS: We selected a variety of measures/items from the Patient-Reported Outcomes Measurement Information System (PROMIS) representing different domains. We purposefully sampled patients ~6-12 weeks post-SAB/GNB and conducted 2 rounds of cognitive interviews to refine the survey by exploring patients' understanding of items and answer selection as well as relevance for capturing HRQoL. RESULTS: We interviewed 17 SAB/GNB patients. Based on the first round of cognitive interviews (n = 10), we revised the survey. After round 2 of cognitive interviewing (n = 7), we finalized the survey to include 10 different PROMIS short forms/measures of the most salient HRQoL domains and 2 adapted questions (41 items total) that were found to adequately capture HRQoL. CONCLUSIONS: We developed a survey from well-established PRO measures that captures what matters most to SAB/GNB patients as they recover. This survey, uniquely tailored to bloodstream infections, can be used to assess these meaningful, important HRQoL outcomes in clinical trials and in patient care. Engaging patients is crucial to developing treatments for bloodstream infections.

Race, Income, and Medical Care Spending Patterns in High-Risk Primary Care Patients: Results From the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) Study.

RATIONALE & OBJECTIVE: Little is known about how socioeconomic status (SES) relates to the prioritization of medical care spending over personal expenditures in individuals with multiple comorbid conditions, and whether this relationship differs between Blacks and non-Blacks. We aimed to explore the relationship between SES, race, and medical spending among individuals with multiple comorbid conditions. STUDY DESIGN: Cross-sectional evaluation of baseline data from a randomized controlled trial. SETTING & PARTICIPANTS: The STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) study is a completed randomized controlled trial of Duke University primary care patients with diabetes, hypertension, and chronic kidney disease. Participants underwent survey assessments inclusive of measures of socio-demographics and medication adherence. PREDICTORS: Race (Black or non-Black) and socioeconomic status (income, education, and employment). OUTCOMES: The primary outcomes were based on 4 questions related to spending, asking about reduced spending on basic/leisure needs or using savings to pay for medical care. Participants were also asked if they skipped medications to make them last longer. ANALYTICAL APPROACH: Multivariable logistic regression stratified by race and adjusted for age, sex, and household chaos was used to determine the independent effects of SES components on spending. RESULTS: Of 263 STOP-DKD participants, 144 (55%) were Black. Compared with non-Blacks, Black participants had lower incomes with similar levels of education and employment but were more likely to reduce spending on basic needs (29.2% vs 13.5%), leisure activities (35.4% vs 20.2%), and to skip medications (31.3% vs 15.1%), all P < 0.05. After multivariable adjustment, Black race was associated with increased odds of reduced basic spending (OR, 2.29; 95% CI, 1.14-4.60), reduced leisure spending (OR, 1.94; 95% CI, 1.05-3.58), and skipping medications (OR, 2.12; 95% CI, 1.12-4.04). LIMITATIONS: This study was conducted at a single site in Durham, North Carolina, and nearly exclusively included insured patients. Further, the impact of the number of comorbid conditions, medication costs, or copayments was not assessed. CONCLUSIONS: In primary care patients with multiple chronic diseases, Black patients are more likely to reduce spending on basic needs and leisure activities to afford their medical care than non-Black patients of equivalent SES. CLINICALTRIALSGOV IDENTIFIER: NCT01829256.

Performance of middle cerebral artery doppler for prediction of recurrent fetal anemia.

OBJECTIVE: To assess the predictive value of middle cerebral artery Doppler peak systolic velocity (MCA-PSV) for moderate-severe fetal anemia following one intrauterine transfusion (IUT) and test the performance of alternate cutoffs to the recommended threshold ≥1.69 multiples of the median (MoM). METHODS: This was a retrospective cohort study of patients with pregnancies affected by alloimmunization who underwent percutaneous umbilical blood sampling (PUBS) procedures from 2000 to 2020. An MCA-PSV ≥1.69 MoM was the indication for the second IUT. The primary outcome was recurrent moderate-severe fetal anemia. Receiver-operating characteristic (ROC) curves assessed the predictive ability of MCA-PSV for the primary outcome and the Youden index identified the "optimal" cutoff value. Predictive characteristics of MCA-PSV ≥1.69 MoM and the "optimal" cutoff were compared. RESULTS: Of the 58 patients who underwent IUT during the study period, 36 (62%) did not meet inclusion criteria. Of the remaining 22 patients who underwent a second PUBS, 12 (54.6%) fetuses had moderate or severe anemia. Following one IUT, the AUC for MCA-PSV was 0.86 (95% CI 0.70-1.00) for the primary outcome. The "optimal" cutoff MCA-PSV value was 1.74 MoM, which had a greater specificity than ≥1.69 MoM (90 vs. 50%, p = .05), but was not statistically significant. The sensitivity was similar between the two cutoff values of ≥1.69 and ≥1.74 MoM (83.3 vs. 75.0%, p = .65) (Table 2). CONCLUSION: Raising the recommended MCA-PSV cutoff to ≥1.74 MoM for recurrent moderate-severe fetal anemia after one IUT would decrease the number of unnecessary procedures without significantly changing the sensitivity of this screening test.

Changes in the Antenatal Utilization of High-Risk Obstetric Services and Stillbirth Rate during the COVID-19 Pandemic.

OBJECTIVE: The primary objective of this study was to evaluate coronavirus 2019 (COVID-19) pandemic-related changes in the antenatal utilization of high-risk obstetric services. Our secondary objective was to characterize change in stillbirth rate during the pandemic. STUDY DESIGN: This is a retrospective, observational study performed at a single, tertiary care center. Maternal-Fetal Medicine (MFM) visits, ultrasounds, and antenatal tests of fetal well-being during the pandemic epoch (2020), which spans the first 12 weeks of the year to include pandemic onset and implementation of mitigation efforts, were compared with the same epoch of the three preceding years visually and using general linear models to account for week and year effect. An analysis of stillbirth rate comparing the pandemic time period to prepandemic was also performed. RESULTS: While there were decreased MFM visits and antenatal tests of fetal well-being during the pandemic epoch compared with prepandemic epochs, only the decrease in MFM visits by year was statistically significant (p < 0.001). The stillbirth rate during the pandemic epoch was not significantly different when compared with the prepandemic period and accounting for both week (p = 0.286) and year (p = 0.643) effect. CONCLUSION: The COVID-19 pandemic resulted in a significant decrease in MFM visits, whereas obstetric ultrasounds and antenatal tests of fetal well-being remained unchanged. While we observed no change in the stillbirth rate compared with the prepandemic epoch, our study design and sample size preclude us from making assumptions of association. Our findings may support future work investigating how changes in prenatal care for high-risk obstetric patients influence perinatal outcomes. KEY POINTS: · MFM visits significantly decreased during the COVID-19 pandemic epoch.. · The overall stillbirth rate during the COVID-19 pandemic epoch was not significantly changed.. · Larger studies are needed to capitalize on these changes to evaluate rare outcomes such as stillbirth..

Complicated placenta accreta spectrum: identifying a high-risk cohort.

OBJECTIVE: To assess differences in the perioperative complication rate between patients with placenta accreta spectrum (PAS) with and without complicating factors. METHODS: This retrospective cohort study included subjects who underwent cesarean hysterectomy with histology-proven PAS between 23 0/7 and 42 0/7 weeks gestational age (GA) from 1 July 2008 to 11 April 2017. Perioperative outcomes were compared between those with uncomplicated PAS and "complicated PAS," defined as PAS subjects who experienced ≥2 bleeding episodes, preterm premature rupture of membranes (PPROM), or premature contractions requiring tocolysis. RESULTS: Overall, 26 complicated PAS and 27 uncomplicated PAS cases were compared; no difference in the rate of perioperative complications was identified. An increased proportion of complicated PAS cases required blood product transfusion before delivery: 2 (40%), 3 (27.3%), and 2 patients (20%) for those with PPROM, preterm contractions, and ≥2 bleeding episodes respectively, compared to patients with uncomplicated PAS, having no transfusions (p = .001). Time of delivery was earlier for patients with complicated compared to uncomplicated PAS (median GA 30.9 [Q1 = 27.9; Q3 = 31.9] and 34.9 [Q1 = 32.1; Q3 = 35.7], p < .001). Median birthweights were lower (p < .0144) and maternal length of stay longer (p < .0012) for complicated PAS. CONCLUSION: Patients with complicated PAS were not at higher risk for perioperative complications but were associated with earlier delivery, required more antenatal blood transfusions, and had a longer LOS.

Offering onsite COVID-19 vaccination to high-risk obstetrical patients: initial findings.

OBJECTIVE: The COVID-19 pandemic has had a disproportionate effect on pregnant women, with higher rates of viral infection and disease severity.1 The development of highly effective vaccines has significantly reduced SARS-CoV-2 transmission and clinical disease.2 However, vaccine uptake has been low in the pregnant population.3 The Centers for Disease Control and Prevention guidance suggests that limited vaccine access, not vaccine hesitancy, has driven the lower uptake rates in at-risk populations.4 We describe our experience with vaccination uptake rates among high-risk obstetrical patients before and after onsite BNT162b2 messenger RNA vaccination availability in outpatient clinics as part of a pilot program to improve vaccine access among pregnant patients. STUDY DESIGN: This was a quality improvement project at a single academic medical center. Onsite vaccination was available once a week at 2 high-risk obstetrical clinics staffed by obstetrical residents, maternal-fetal medicine (MFM) fellows, and MFM attendings were selected for our vaccine pilot program. Onsite vaccinations were immediately available for use in the clinic starting May 11, 2021. Data were collected over a 4-week period (April 27, 2021, to May 20, 2021), which included 4 clinic days before onsite vaccine availability (April 27, 2021 to May 10, 2021) and 4 days with onsite vaccine availability (May 11, 2021, to May 20, 2021). Patients were considered exposed to onsite vaccination if they had any clinic visits during the latter 2 weeks of the study period. All patients were counseled by providers at each visit using our institution's standardized COVID-19 vaccination discussion tool designed for pregnant and breastfeeding patients.5 Counseling was documented in each patient's chart per the American College of Obstetricians and Gynecologists. Before and throughout the study period, pregnancy was listed as a qualifying condition for priority vaccination in Missouri and Illinois. At this time, vaccinations were readily available in the local area surrounding our clinical space. Data on vaccine administration were collected via the Missouri and Illinois state databases over a period of 1 month after the pilot program was closed, allowing for the collection of data on patients who pursued vaccination offsite for scheduling or personal reasons. This project was deemed exempt by the Office for Human Research Protections. RESULTS: We reviewed data from 124 clinic visits, where a total of 93 individual patients were seen in the 4-week period; 6 had previously been vaccinated at external sites and the remaining 87 were eligible (Figure). The majority of our patient population was non-Hispanic Black women with public or no insurance (Table). Of the 32 eligible patients seen and counseled before onsite vaccination availability, 1 (3%) proceeded to receive the vaccination offsite. Of the 55 eligible patients seen and counseled after onsite vaccination availability, 2 (3%) proceeded with onsite vaccination and an additional 4 (7%) proceeded with vaccination offsite. Onsite vaccination availability did not significantly increase the vaccination rates (3% vs 11%; P=.22). Of the 55 eligible patients counseled during onsite vaccination availability, 25 were seen and counseled exclusively during the onsite vaccination pilot period and none of these patients accepted onsite vaccination or pursued vaccination offsite. CONCLUSION: Because only 3% of eligible, high-risk obstetrical patients proceeded with onsite vaccination, our experience suggests that vaccine hesitancy, not availability, is a critical driver of the low vaccination rates in this population. Although a larger sample size may have demonstrated statistical difference, the overall low vaccination uptake rate forced the closure of our pilot program over concerns for wasted vaccination doses. In a population at high risk for progression to severe COVID-19, only 14% of our study population was vaccinated, whereas Missouri reported a 41% vaccination rate during this time.6 These findings suggest that increased access alone may not improve vaccination rates in obstetrical patients even after counseling by expert clinicians. These findings are limited by the pre/post nature of the comparison, exposing the sample to bias as vaccination recommendations and population sentiment was rapidly evolving during this time period. However, the consistency of counseling and patient population provided by a single clinical setting limited other sources of bias during the study period. Vaccine hesitancy is multifactorial and complex and urgently requires more evaluation in this high-risk population. Vaccine hesitancy in pregnancy is well documented, but early reports suggest that the COVID-19 vaccination uptake rate is markedly lower than that of other vaccines during pregnancy. Our finding that none of the women who were seen exclusively during the onsite vaccination period accepted vaccination may suggest that repeat clinic visits and the associated establishment of rapport and trust is a vital part of vaccine decision making. Earlier intervention, before patient views on novel therapeutics such as vaccinations can be formulated and fixed, may aid in uptake. Further qualitative work and inclusion of pregnant women in vaccine trials is an initial step.

Impact of financial medication assistance on medication adherence: a systematic review.

BACKGROUND: The prevalence of financial medication assistance (FMA), including patient assistance programs, coupons/copayment cards, vouchers, discount cards, and programs/pharmacy services that help patients apply for such programs, has increased. The impact of FMA on medication adherence and persistence has not been synthesized. OBJECTIVE: The primary objective of this study was to review published studies evaluating the impact of FMA on the three phases of medication adherence (initiation [or primary adherence], implementation [or secondary adherence], and discontinuation) and persistence. Among these studies, the secondary objective was to report the impact of FMA on patient out-of-pocket costs and clinical outcomes. METHODS: A systematic review was performed using MEDLINE and Web of Science. RESULTS: Of 656 articles identified, eight studies met all inclusion criteria. Seven studies examined FMA for medications treating cardiovascular diseases, while one study assessed FMA for cancer medications. Among included studies, FMA had a positive impact on medication adherence or persistence, and most measured this impact over one year or less. Of the three phases of medication adherence, implementation (5 of 8) was most commonly reported, followed by discontinuation (3 of 8), and then initiation (1 of 8). Regarding implementation, users of FMA had a higher mean medication possession ratio (MPR) than nonusers, ranging from 7 to 18 percentage points higher. The percentage of patients who discontinued medication was 7 percentage points lower in users of FMA versus nonusers for cardiovascular disease states. In one cancer study, FMA had a larger impact on initiation than discontinuation, ie, compared to nonusers, users of FMA were less likely to abandon an initial prescription (risk ratio= 0.12, 95% confidence interval [CI]: 0.08-0.18), and this effect was larger than the decreased likelihood of discontinuing the medication (hazard ratio = 0.76, 95% CI: 0.66-0.88). In 3 of 8 studies reporting on medication persistence, FMA increased the odds of medication persistence for one year ranged from 11% to 47%, depending on the study. In addition to adherence, half of the studies reported on FMA impacts on patient out-of-pocket costs and 3 of 8 studies reported on clinical outcomes. Impacts on patient out-of-pocket costs were mixed; two studies reported that out-of-pocket costs were higher for users of a coupon or a voucher versus nonusers, one study reported the opposite, and one study reported null effects. Impacts on clinical outcomes were either positive or null. CONCLUSIONS: We found that FMA has positive impacts on all phases of medication adherence as well as medication persistence over one year. Future studies should assess whether FMA has differential impacts based on phase of medication adherence and report on its longer-term (ie, beyond one year) impacts on medication adherence. DISCLOSURES: This work was sponsored by a grant from Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Hung reports past employment by Blue Cross Blue Shield Association and CVS Health and a grant from PhRMA outside of the submitted work. Zullig reports research funding from Proteus Digital Health and the PhRMA Foundation. consulting fees from Novartis. Reed reports receiving research support from Abbott Vascular, AstraZeneca, Janssen Research & Development, Monteris, PhRMA Foundation, and TESARO and consulting fees from Sanofi/Regeneron, NovoNordisk, SVC Systems, and Minomic International, Inc. Bosworth reports research grants from the PhRMA Foundation, Proteus Digital Health, Otsuka, Novo Nordisk, Sanofi, Improved Patient Outcomes, Boehinger Ingelheim, NIH, and VA, as well as consulting fees from Sanofi, Novartis, Otsuka, Abbott, Xcenda, Preventric Diagnostics, and the Medicines Company. The other authors have nothing to report. This work was presented as a poster presentation at the ESPACOMP Annual Meeting in November 2020.

Pregnancy as a risk factor for severe coronavirus disease 2019 using standardized clinical criteria.

BACKGROUND: As of November 18, 2020, more than 11 million people have been infected with coronavirus disease 2019 and almost 250,000 people have died from the disease in the United States, less than 1 year since its discovery. Although literature is beginning to emerge on pregnancy as a risk factor for severe coronavirus disease 2019, these studies are heterogeneous and use primary outcomes such as intensive care unit admission or hospitalization as surrogate markers that may subject analyses to misclassification bias in pregnant patients. OBJECTIVE: This study aimed to determine the risk of severe coronavirus disease 2019 among pregnant women with symptomatic coronavirus disease 2019 compared with nonpregnant women using nonadmission-based, standardized clinical criteria for severe disease. STUDY DESIGN: This is a retrospective cohort study of women aged 13 to 45 years and diagnosed as having symptomatic coronavirus disease 2019 between May 28, 2020, and July 22, 2020. The primary outcome was severe coronavirus disease 2019 as defined by 2 sets of nonadmission-based, clinical criteria: the World Health Organization Ordinal Scale for Clinical Improvement and the Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. Adjusted risk ratios were estimated using multivariable logistic regression analyses. RESULTS: Of 262 women aged 13 to 45 years with symptomatic coronavirus disease 2019, 22 (8.4%) were pregnant and 240 (91.6%) were nonpregnant. After adjusting for covariates potentially associated with the primary outcome, symptomatic pregnant women were at a significantly increased risk of severe coronavirus disease 2019 compared with nonpregnant women using both the World Health Organization Ordinal Scale for Clinical Improvement (adjusted relative risk, 3.59; 95% confidence interval, 1.49-7.01) and Novel Coronavirus Pneumonia Emergency Response Epidemiology Team (adjusted relative risk, 5.65; 95% confidence interval, 1.36-17.31) criteria. CONCLUSION: Pregnancy significantly increases the risk of severe coronavirus disease 2019 as defined by nonadmission-based, clinical criteria.

Patients' Experiences With Staphylococcus aureus and Gram-negative Bacterial Bloodstream Infections: A Qualitative Descriptive Study and Concept Elicitation Phase To Inform Measurement of Patient-reported Quality of Life.

BACKGROUND: Although Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) cause substantial morbidity, little is known regarding patient perceptions' of their impact on quality of life (QOL). Guidance for assessing QOL and disease-specific measures are lacking. We conducted a descriptive qualitative study to gain an in-depth understanding of patients' experiences with SAB/GNB and concept elicitation phase to inform a patient-reported QOL outcome measure. METHODS: We conducted prospective one-time, in-depth, semi-structured, individual, qualitative telephone interviews 6- 8 weeks following bloodstream infection with either SAB or GNB. Patients were enrolled in an institutional registry (tertiary academic medical center) for SAB or GNB. Interviews were audio-recorded, transcribed, and coded. Directed content analysis identified a priori and emergent themes. Theme matrix techniques were used to facilitate analysis and presentation. RESULTS: Interviews were completed with 30 patients with SAB and 31 patients with GNB. Most patients were at or near the end of intravenous antibiotic treatment when interviewed. We identified 3 primary high-level concepts: impact on QOL domains, time as a critical index, and sources of variability across patients. Across both types of bloodstream infection, the QOL domains most impacted were physical and functional, which was particularly evident among patients with SAB. CONCLUSIONS: SAB/GNB impact QOL among survivors. In particular, SAB had major impacts on multiple QOL domains. A combination of existing, generic measures that are purposefully selected and disease-specific items, if necessary, could best capture these impacts. Engaging patients as stakeholders and obtaining their feedback is crucial to conducting patient-centered clinical trials and providing patient-centered care.

Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.

BACKGROUND: African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline. OBJECTIVE: The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline. RESEARCH DESIGN: Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control. MEASURES: The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm. RESULTS: Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02). CONCLUSION: A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.

Lessons learned from two randomized controlled trials: CITIES and STOP-DKD.

BACKGROUND: Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings. OBJECTIVES: Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials. METHODS: These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina. CONCLUSIONS: We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens. TRIAL REGISTRATION: Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.

Use of a human-centered design approach to adapt a nurse-led cardiovascular disease prevention intervention in HIV clinics.

Stakeholder-informed strategies addressing cardiovascular disease (CVD) burden among people living with HIV (PWH) are needed within healthcare settings. This study provides an assessment of how human-centered design (HCD) guided the adaptation of a nurse-led intervention to reduce CVD risk among PWH. Using a HCD approach, research staff guided two multidisciplinary "design teams" in Ohio and North Carolina, with each having five HCD meetings. We conducted acceptability and feasibility testing. Six core recommendations were produced by two design teams of key stakeholders and further developed after the acceptability and feasibility testing to produce a final list of 14 actionable areas of adaptation. Acceptability and feasibility testing revealed areas for adaptation, e.g. patient preferences for communication and the benefit of additional staff to support patient follow-up. In conclusion, along with acceptability and feasibility testing, HCD led to the production of 14 key recommendations to enhance the effectiveness and scalability of an integrated HIV/CVD intervention.