Socioemotional Development of Infants and Toddlers During the COVID-19 Pandemic.

Importance: Understanding the impact of the COVID-19 pandemic on children's socioemotional development is critical to plan for ongoing needs in the early intervention and education systems. Objective: To determine if Ages and Stages Questionnaire, Third Edition (ASQ-3) and Ages and Stages Questionnaire Social-Emotional, Second Edition (ASQ:SE-2) scores changed during the COVID-19 pandemic among families served by a nurse-visiting program. Design, Setting, and Participants: This retrospective, cohort study took place from 2015 through 2021 and included 4 cohorts (prepandemic, pandemic 1, pandemic 2, and pandemic 3) with differing pandemic exposure at the time of screening. Analysis was conducted from July 2022 through October 2023. Data from the Nurse-Family Partnership (NFP), a national nurse-visiting program enrolling birthing people during pregnancy and continuing through age 2 years, were used. A total of 60 171 families with a singleton birth at 37 weeks' gestation or longer and at least 1 valid ASQ-3 and/or ASQ:SE-2 screening in the NFP from January 1, 2015, through December 31, 2021, were enrolled. Exposure: COVID-19 pandemic. Main Outcomes and Measures: Outcomes were a positive screening, defined as scores in the refer area on the ASQ-3 at 10 months and 18 months of age and in the ASQ:SE-2 at 12 months and 18 months of age. Multivariable mixed-effects logistic regression models were used to calculate odds ratios (ORs) for positive screening in pandemic cohorts compared with the prepandemic cohort. Covariates included parent age, race and ethnicity, marital status, income, child's biological sex, and multiparity. Results: Of 60 171 families enrolled, pandemic cohorts had fewer teenagers, were more likely to be married, and were multiparous. Compared with the prepandemic cohort, all pandemic cohorts had higher odds of positive screening on the ASQ-SE at 12 months (pandemic 1: OR, 1.35; 95% CI, 1.09-1.66; pandemic 2: OR, 1.60; 95% CI, 1.30-1.96; and pandemic 3: OR, 1.94; 95% CI, 1.61-2.33) and pandemic 2 and 3 had higher odds of a positive screening at 18 months (pandemic 2: OR, 1.61; 95% CI, 1.29-2.00 and pandemic 3: OR, 1.87; 95% CI, 1.50-2.32). On the ASQ-3, pandemic cohorts 2 and 3 were more likely than the prepandemic cohort to screen positive on the communication subscale at 18 months (pandemic 2: OR, 1.39; 95% CI, 1.17-1.64 and pandemic 3: OR, 1.28; 95% CI, 1.07-1.53). Conclusions and Relevance: In this study, exposure to the COVID-19 pandemic, especially during the first year of life, was associated with higher odds of positive ASQ:SE-2 screening, even when adjusting for demographics and family risks. These findings suggest that unmeasured community, family, and child factors that changed as a result of the pandemic contributed to delays in young children's socio-emotional development.

Clinical Inertia Among Outpatients With Heart Failure: Application of Treatment Nonintensification Taxonomy to EPIC-HF Trial.

BACKGROUND: The contribution of clinical inertia to suboptimal guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) remains unclear. OBJECTIVES: This study examined reasons for GDMT nonintensification and characterized clinical inertia. METHODS: In this secondary analysis of EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction), a randomized clinical trial evaluating a patient-activation tool on GDMT utilization, we performed a sequential, explanatory mixed-methods study. Reasons for nonintensification among 4 medication classes were assigned according to an expanded published taxonomy using structured chart reviews. Audio transcripts of clinic encounters were analyzed to further characterize nonintensification reasons. Integration occurred during the interpretation phase. RESULTS: Among 292 HFrEF patients who completed a cardiology visit, 185 (63.4%) experienced no treatment intensification, of whom 90 (48.6%) had at least 1 opportunity for intensification of a medication class with no documented contraindication or barriers (ie, clinical inertia). Nonintensification reasons varied by medication class, and included heightened risk of adverse effects (range 18.2%-31.6%), patient nonadherence (range 0.8%-1.1%), patient preferences and beliefs (range 0.6%-0.9%), comanagement with other providers (range 4.6%-5.6%), prioritization of other issues (range 15.6%-31.8%), multiple categories (range 16.5%-22.7%), and clinical inertia (range 22.7%-31.6%). A qualitative analysis of 32 clinic audio recordings demonstrated common characteristics of clinical inertia: 1) clinician review of medication regimens without education or intensification discussions; 2) patient stability as justification for nonintensification; and 3) shorter encounters for nonintensification vs intensification. CONCLUSIONS: In this comprehensive study exploring HFrEF prescribing, clinical inertia is a main contributor to nonintensification within an updated taxonomy classification for suboptimal GDMT prescribing. This approach should help target strategies overcoming GDMT underuse.

Esophagram should be performed to diagnose esophageal perforation before inter-hospital transfer.

Background: Early recognition of esophageal perforation may prevent morbidity and mortality, and accurate diagnostic imaging facilitates triage. Stable patients with suspected perforation may be transferred to higher levels of care before appropriate work-up and diagnosis confirmation. We reviewed patients transferred for esophageal perforation to critically analyze the diagnostic workflow. Methods: We performed a retrospective review of patients transferred to our tertiary care institution from 2015-2021 for suspected esophageal perforation. Demographics, referring site characteristics, diagnostic studies, and management were analyzed. Bivariate comparisons were performed using Wilcoxon-Mann-Whitney tests for continuous variables and chi-squared or Fisher's exact tests for categorical variables. Results: Sixty-five patients were included. Etiology of suspected perforation was spontaneous in 53.8% and iatrogenic in 33.8%. Most patients were transferred within 24 hours from time of suspected perforation (66.2%). Transferring sites included seven states and were 101-300 miles (32.3%) or >300 miles (26.2%) away. CT imaging was obtained in 96.9% before transfer, most commonly demonstrating pneumomediastinum (46.2%). Only 21.5% of patients had an esophagram before transfer. Following transfer, 36.9% (n=24) were ultimately not found to have esophageal perforation, demonstrated by negative arrival esophagram in 79.1%. In patients with confirmed perforation (n=41), 58.5% had surgery, 26.8% endoscopic intervention, and 14.6% supportive care. Conclusions: After transfer a proportion of patients were ultimately found to not have esophageal perforation, typically demonstrated by negative esophagram upon arrival. We conclude that a recommendation of performing esophagram at the presenting site, when possible, may prevent unnecessary transfers, and will likely reduce costs, conserve resources, and decrease management delays.

Analysis of Time Between Skin Lesion and Lymph Node Biopsies and Lymph Node Metastasis in Patients With Melanoma.

This cohort study assesses whether increasing time to surgery is associated with sentinel lymph node status in patients with cutaneous melanoma stage T1b or higher.

Long-Term Patient-Reported Symptom Improvement and Quality of Life after Transthoracic Diaphragm Plication in Adults.

BACKGROUND: Open and robotic-assisted transthoracic approaches for diaphragm plication are accepted surgical interventions for diaphragm paralysis and eventration. However, long-term patient-reported symptom improvement and quality of life (QOL) remains unclear. STUDY DESIGN: A telephone-based survey was developed focusing on postoperative symptom improvement and QOL. Patients who underwent open or robotic-assisted transthoracic diaphragm plication (2008-2020) across three institutions were invited to participate. Patients who responded and provided consent were surveyed. Likert responses on symptom severity were dichotomized and rates before and after surgery were compared using McNemar's test. RESULTS: Forty-one percent of patients participated (43 of 105 responded, mean age 61.0 years, 67.4% male, 37.2% robotic-assisted surgery), with an average time between surgery and survey of 4.1 ± 3.2 years. Patients reported significant improvement in dyspnea while lying flat (67.4% pre- vs 27.9% postoperative, p < 0.001), dyspnea at rest (55.8% pre- vs 11.6% postoperative, p < 0.001), dyspnea with activity (90.7% pre- vs 55.8% postoperative, p < 0.001), dyspnea while bending over (79.1% pre- vs 34.9% postoperative, p < 0.001), and fatigue (67.4% pre- vs 41.9% postoperative, p = 0.008). There was no statistical improvement in chronic cough. 86% of patients reported improved overall QOL, 79% had increased exercise capacity, and 86% would recommend surgery to a friend with a similar problem. Analysis comparing open and robotic-assisted approaches found no statistically significant differences in symptom improvement or QOL responses between the groups. CONCLUSIONS: Patients report significantly improved dyspneic and fatigue symptoms after transthoracic diaphragm plication, regardless of open or robotic-assisted approach. The majority of patients report improved QOL and exercise capacity.

A comparison of short-term outcomes following robotic-assisted vs. open transthoracic diaphragm plication.

Diaphragm paralysis and eventration are rare conditions in adults. Symptomatic patients may benefit from surgical plication of the elevated hemidiaphragm. The objective of this study was to compare short-term outcomes and length of stay following robotic-assisted vs. open diaphragm plication. A multicenter retrospective study was conducted that identified patients undergoing unilateral hemidiaphragm plication from 5/2008 to 12/2020. The first RATS plication was performed in 11/2018. Electronic medical records were reviewed, and outcomes were compared between RATS and open approach. One hundred patients underwent diaphragm plication, including thirty-nine (39.0%) RATS and sixty-one (61.0%) open cases. Patients undergoing RATS diaphragm plication were older (64 years vs. 55 years, p = 0.01) and carried a higher burden of comorbidities (Charlson Comorbidity Index: 2.0 vs. 1.0, p = 0.02). The RATS group had longer median operative times (146 min vs. 99 min, p < 0.01), but shorter median hospital length of stays (3.0 days vs. 6.0 days, p < 0.01). There was a non-significant trend toward a decreased rate of 30-day postoperative complications (20.5% RATS vs. 32.8% open, p = 0.18) and 30-day unplanned readmissions (7.7% RATS vs. 9.8% open, p > 0.99). RATS is a technically feasible and safe option for performing diaphragm plications. This approach increases the surgical candidacy of older patients with a higher burden of comorbid disease without increasing complication rates, while reducing length of hospital stay.

Patient Pill Organization Strategies and Adherence Measured in a Cross-Sectional Study of Hypertension.

Background: The strategies patients use to organize medications (eg, pill dispenser) may be reflected in adherence measured at follow-up. We studied whether medication organization strategies patients use at home are associated with adherence measured using pharmacy-fills, self-report, and pill counts. Design: Secondary analysis of data from a prospective randomized clinical trial. Setting: Eleven US safety-net and community primary care clinics. Patients: Of the 960 enrolled self-identified non-Hispanic Black and White patients prescribed antihypertensive medications, 731 patients reported pill organization strategies and were included. Variable: Patients were asked if they use any of the following medication organization strategies: finish previous refills first; use a pill dispenser; combine same prescriptions; or combine dissimilar prescriptions. Outcomes: Adherence to antihypertensive medications using pill counts (range, 0.0-1.0% of the days covered), pharmacy-fill (proportion of days covered >90%), and self-report (adherent/non-adherent). Results: Of the 731 participants, 38.3% were men, 51.7% were age ≥65, 52.9% self-identified as Black or African American. Of the strategies studied, 51.7% finished previous refills first, 46.5% used a pill dispenser, 38.2% combined same prescriptions and 6.0% combined dissimilar prescriptions. Median (IQR) pill count adherence was 0.65 (0.40-0.87), pharmacy-fill adherence was 75.7%, and self-reported adherence was 63.2%. Those who combined same prescriptions had significantly lower measured pill count adherence than those who did not (0.56 (0.26-0.82) vs 0.70 (0.46-0.90), p<0.01) with no significant difference in pharmacy-fill (78.1% vs 74%, p=0.22) or self-reported adherence (63.0% vs 63.3%, p=0.93). Conclusion: Self-reported medication organization strategies were common. Combining same prescriptions was associated with lower adherence as measured using pill counts but not pharmacy-fills or self-report. Clinicians and researchers should identify the pill organization strategies used by their patients to understand how these strategies may influence measures of patient adherence. Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).

Magnitude of troponin elevation in patients with biomarker evidence of myocardial injury: relative frequency and outcomes in a cohort study across a large healthcare system.

BACKGROUND: Serum troponin levels correlate with the extent of myocyte necrosis in acute myocardial infarction (AMI) and predict adverse outcomes. However, thresholds of cardiac troponin elevation that could portend to poor outcomes have not been established. METHODS: In this cohort study, we characterized all cardiac troponin elevations > 0.04 ng/mL (upper limit of normal [ULN]) from patients hospitalized with an ICD-9/10 diagnosis of AMI across our health system from 2012-2019. We grouped events into exponential categories of peak cardiac troponin and evaluated the association of these troponin categories with all-cause mortality, heart transplants, or durable left ventricular assist devices (LVAD). Patients with cardiac troponin > 10,000 × ULN were manually chart reviewed and described. RESULTS: There were 18,194 AMI hospitalizations with elevated cardiac troponin. Peak troponin was 1-10 × ULN in 21.1%, 10-100 × ULN in 34.8%, 100-1,000 × ULN in 30.1%, 1,000-10,000 × ULN in 13.1%, and > 10,000 × ULN in 0.9% of patients. One-year mortality was 17-21% across groups, except in > 10,000 × ULN group where it was 33% (adjusted hazard ratio (99%CI) for > 10,000 × ULN group compared to all others: 1.86 (1.21, 2.86)). Hazards of one-year transplant and MCS were also significantly elevated in the > 10,000 × ULN group. CONCLUSIONS: Elevation in cardiac troponin levels post AMI that are > 10,000 × ULN was rare but identified patients at particularly high risk of adverse events. These patients may benefit from clarification of goals of care and early referral for advanced heart failure therapies. These data have implications for conversion to newer high-sensitivity cardiac troponin assays whose maximum assay limit is often lower than traditional assays.

Reflux and Barrett's esophagus after sleeve gastrectomy: analysis of a statewide database.

BACKGROUND: Recent studies have suggested that sleeve gastrectomy (SG) is associated with the development of Barrett esophagus (BE) even in the absence of gastroesophageal reflux disease (GERD) symptoms. OBJECTIVE: The aim of this study was to assess the rates of upper endoscopy and incidence of new BE diagnoses in patients undergoing SG. SETTING: This was a claims-data study of patients who underwent SG between 2012 and 2017 while enrolled in a U.S. statewide database. METHODS: Diagnostic claims data were used to identify pre- and postoperative rates of upper endoscopy, GERD, reflux esophagitis, and BE. Time-to-event analysis using a Kaplan-Meier approach was performed to estimate the cumulative postoperative incidence of these conditions. RESULTS: We identified 5562 patients who underwent SG between 2012 and 2017. Of these, 1972 patients (35.5%) had at least 1 diagnostic record of upper endoscopy. The preoperative incidences of a diagnosis of GERD, esophagitis, and BE were 54.9%, 14.6%, and .9%, respectively. The predicted postoperative incidences of GERD, esophagitis, and BE, respectively, were 18%, 25.4%, and 1.6% at 2 years and 32.1%, 85.0%, and 6.4% at 5 years. CONCLUSIONS: In this large statewide database, rates of esophagogastroduodenoscopy remained low after SG, but the incidence of a new postoperative esophagitis or BE diagnosis in patients who underwent esophagogastroduodenoscopy was higher than in the general population. Patients undergoing SG may have a disproportionately high risk of developing reflux complications including BE after surgery.

Relationship Between Social Vulnerability Indicators and Trial Participant Attrition: Findings From the HYVALUE Trial.

BACKGROUND: Social vulnerability indicators are associated with health care inequities and may similarly impede ongoing participation in research studies. We evaluated the association of social vulnerability indicators and research participant attrition in a trial focused on reducing health disparities. METHODS: Self-identified White or Black adults enrolled in the HYVALUE trial (Hypertension and VALUEs), a randomized trial testing a values-affirmation intervention on medication adherence, from February 2017 to September 2019 were included. The self-reported measures of social vulnerability indicators included: (1) Black race; (2) female gender; (3) no health insurance; (4) unemployment; (5) a high school diploma or less; and (6) financial-resource strain. Full attrition was defined as not completing at least one 3- or 6-month follow-up study visit. Log-binomial regression models adjusted for age, gender, race, medical comorbidities, and the other social vulnerability indicators to estimate the relative risk of each social vulnerability indicator with study attrition. RESULTS: Among 825 participants, the mean age was 63.3 years (±11.7 years), 60% were women, 54% were Black, and 97% reported at least one social vulnerability. Overall, 21% participants had full attrition after study enrollment. After adjustment for all other social vulnerabilities, only financial-resource strain remained consistently associated with full attrition (relative risk, 1.71 [95% CI, 1.28-2.29]). In a secondary analysis of partial attrition (completed only one follow-up visit), financial-resource strain (relative risk, 1.40 [95% CI, 1.09-1.81]) and being uninsured (relative risk, 1.54 [95% CI, 1.01-2.34]) were associated with partial attrition. CONCLUSIONS: In a trial aimed at reducing disparities in medication adherence, participants who reported financial-resource strain had a higher risk of participant attrition independent of race or gender. Our findings suggest that efforts to retain diverse populations in clinical trials should extend beyond race and gender to consider other social vulnerability indicators. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03028597.

Effect of Values Affirmation on Reducing Racial Differences in Adherence to Hypertension Medication: The HYVALUE Randomized Clinical Trial.

Importance: Stereotype threat, or the fear of confirming a negative stereotype about one's social group, may contribute to racial differences in adherence to medications by decreasing patient activation to manage chronic conditions. Objective: To examine whether a values affirmation writing exercise improves medication adherence and whether the effect differs by patient race. Design, Setting, and Participants: The Hypertension and Values trial, a patient-level, blinded randomized clinical trial, compared an intervention and a control writing exercise delivered immediately prior to a clinic appointment. Of 20 777 eligible, self-identified non-Hispanic Black and White patients with uncontrolled hypertension who were taking blood pressure (BP) medications, 3891 were approached and 960 enrolled. Block randomization by self-identified race ensured balanced randomization. Patients enrolled between February 1, 2017, and December 31, 2019, at 11 US safety-net and community primary care clinics, with outcomes assessed at 3 and 6 months. Analysis was performed on an intention-to-treat basis. Interventions: From a list of 11 values, intervention patients wrote about their most important values and control patients wrote about their least important values. Main Outcomes and Measures: The primary outcome of adherence to BP medications was measured using pharmacy fill data (proportion of days covered >90%) at baseline, 3 months, and 6 months. The secondary outcome was systolic and diastolic BP. Patient activation to manage their health was also measured. Results: Of 960 patients, 474 (286 women [60.3%]; 256 Black patients [54.0%]; mean [SD] age, 63.4 [11.9] years) were randomly assigned to the intervention group and 486 (288 women [59.3%]; 272 Black patients [56.0%]; mean [SD] age, 62.8 [12.0] years) to the control group. Baseline medication adherence was lower (318 of 482 [66.0%] vs 331 of 412 [80.3%]) and mean (SE) BP higher among Black patients compared with White patients (systolic BP, 140.6 [18.5] vs 137.3 [17.8] mm Hg; diastolic BP, 83.9 [12.6] vs 79.7 [11.3] mm Hg). Compared with baseline, pharmacy fill adherence did not differ between intervention and control groups at 3 months (odds ratio [OR], 0.91 [95% CI, 0.57-1.43]) or at 6 months (OR, 0.86 [95% CI, 0.53-1.38]). There were also no treatment effect differences in pharmacy fill adherence by patient race (Black patients at 3 months: OR, 1.08 [95% CI, 0.61-1.92]; at 6 months: OR, 1.04 [95% CI, 0.58-1.87]; White patients at 3 months: OR, 0.68 [95% CI, 0.33-1.44]; at 6 months: OR, 0.55 [95% CI, 0.24-1.27]). Immediately after the intervention, the median patient activation was higher in intervention patients than in control patients, but this difference was not statistically significant in an unadjusted comparison (75.0 [IQR, 65.5-84.8] vs 72.5 [IQR, 63.1-80.9]; P = .06). In adjusted models, the Patient Activation Measure score immediately after the intervention was significantly higher in the intervention patients than in control patients (mean difference, 2.3 [95% CI, 0.1-4.5]). Conclusions and Relevance: A values affirmation intervention was associated with higher patient activation overall but did not improve adherence or blood pressure among Black and White patients with hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03028597.

Bikes for Life: Measuring the effects of a bicycle distribution program on 6 to 12-year-old children's BMI and health behaviors.

Treating pediatric obesity is challenging. The objective was to evaluate effect of receiving a bicycle on (a) physical activity, (b) sedentary activity, (c) Body Mass Index (BMI), and (d) eating habits. A stepped-wedge randomized controlled trial of 6- to 12-year-old patients with overweight/obesity was conducted April 2012-2018. Participants were randomized to wait 0, 2, 4, or 6 months for a bicycle. Outcomes on activity, BMI and eating were collected at 3, 6, 9- and 12-months after children received a bicycle. A total of 525 participants with 387 (74%) completed 3-month follow-up questionnaire, and 346 (66%) completed 12-month follow-up visit. Participants were mostly Latino/a (71%) and low income (58%), and 31% had never ridden a bicycle. Median baseline BMI was 98th percentile. At 3 months, 62% reported bicycle use last week, on average 3.6 days. Time spent on sedentary activities decreased by 48 min/day (p = 0.04), and time spent playing sports increased by 1.7 h/week (p < 0.01). No reduction in BMI was seen. Consumption of sugary drinks decreased (by 0.59 servings/week, p < 0.01), and consumption of vegetables increased (0.71 servings/week, p = 0.04). At 12 months, sedentary time, sugary drink and vegetable consumption remained significantly more favorable than at enrollment (p < 0.01, p < 0.01, p = 0.04 respectively), but not significantly different (p = 0.47 for sedentary, p = 0.73 for sugary drink) and significantly less favorable (p < 0.01 for vegetables) than at the time of intervention. Participants reported riding bicycle, improved activity and dietary habits, though reversion towards baseline behavior was seen by one year and no change in BMI from enrollment.

Determining the incidence of postbariatric surgery emergency department utilization: an analysis of a statewide insurance database.

BACKGROUND: Prior studies have found rates of emergency department (ED) visits after bariatric surgery approach 15% with the majority (>60%) not requiring admission. The timeframe for which ED utilization remains elevated postoperatively remains unknown. We hypothesize that ED utilization following bariatric surgery remains elevated for months after surgery with the majority of visits not requiring admission. OBJECTIVE: No study has determined the impact bariatric surgery has on health care resource utilization in the two years following surgery. The aim of this study is to determine the frequency of ED visitation in the 2 years following bariatric surgery. SETTINGS: Database study, single state-wide insurance database. METHODS: We queried the Colorado All Payers Claim Database. Patients with data 1 year before and 2 years after surgery were included. Primary outcomes of interest were ED visits or readmissions during the 2-year period. Bariatric surgeries were identified using CPT codes. Diagnoses for an ED visit or readmission were determined by ICD codes. RESULTS: A total of 5399 patients underwent bariatric surgery from January 2013-November 2017. Of these, 59% underwent sleeve gastrectomy, 38% Roux-en-Y, 2% gastric band, and 1% another surgery. Median age was 44 (IQR 35-54) years, and 82% were female. Overall, 3103 patients (57%) visited the ED at least once with a total of 12,988 visits, 1267 of which (9.8%) resulted in admission. ED use was highest in the 30 days following surgery (17%) but remained above presurgery baseline for 8 months (7.4% at 8 mo compared with baseline mean 6.4% [95% CI 6.0%-6.8%]). CONCLUSIONS: ED visits remain elevated for 8 months post bariatric surgery with over 90% of visits not requiring an admission. Interventions that prevent emergency department utilization should be key focus of quality improvement projects to limit health care resource utilization following bariatric surgery.

A validated modification of the vaccine hesitancy scale for childhood, influenza and HPV vaccines.

INTRODUCTION: Vaccine hesitancy contributes to outbreaks of preventable disease worldwide. The Vaccine Hesitancy Scale (VHS), developed by the international WHO SAGE Working Group, has been validated previously for measuring hesitancy towards childhood vaccines; some psychometric properties were suboptimal. METHODS: We collected data using large, nationally-representative samples of parents in the U.S. We adapted the VHS items, and additional hesitancy items, to assess hesitancy towards influenza and HPV vaccines in addition to routine childhood vaccines. We then used exploratory and confirmatory factor analysis to identify latent constructs and create modified scales for childhood (VHS-child), influenza (VHS-flu) and HPV (VHS-HPV) vaccines with improved psychometric properties. Finally, we compared hesitancy scores on the VHS-child, VHS-flu, and VHS-HPV, to self-reported receipt of each vaccine category, and compared subscale scores to assess whether drivers of hesitancy differed by vaccine category. RESULTS: 2052 parents of children <18 years old completed the VHS-child and VHS-flu while 2020 parents of adolescents completed the VHS-HPV. A two-factor structure of 'risks' and a 'lack of confidence' was found for each vaccine category. Slight modifications to the VHS improved psychometric properties. Hesitancy was strongly associated with vaccine receipt: e.g., 76% of parents not hesitant towards influenza vaccine had vaccinated their child the past season, versus 9% of hesitant parents (p < 0.0001). Subscale scores also differed significantly between vaccines: lack of confidence was greater towards influenza (Median (IQR): 2.0 (1.2, 3.3)) and HPV (2.0 (1.3, 3.0)) vaccines than childhood (1.2 (1.0, 1.8), p < 0.0001 for both) vaccines; perceived risks of HPV vaccines (2.7 (1.7, 3.7)) were greater than for childhood vaccines (2.0 (1.3, 3.0), p < 0.0001). CONCLUSIONS: Our modified VHS scales perform well psychometrically and allow for consistent measurement of the extent and reasons for hesitancy between vaccine categories. We suggest that future work use these scales to examine hesitancy towards other vaccines and to monitor hesitancy over time.

Outcomes After Converted Minimally Invasive to Open Esophagectomy in Patients With Esophageal Cancer.

BACKGROUND: The objective of this study was to evaluate the impact of unplanned conversion to open esophagectomy during minimally invasive esophagectomy (MIE) on postoperative morbidity and mortality for patients with esophageal cancer, as well as to evaluate the variables that influence the need for conversion. METHODS: This study was a retrospective analysis of patients with esophageal cancer who underwent open esophagectomy or MIE by either a laparothoracoscopic approach or a robotic approach from 2016 to 2018 by using the esophagectomy-specific American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database. Poisson regression models were used to analyze 30-day outcomes and risk factors for conversion to open esophagectomy during attempted MIE. RESULTS: A total of 2616 patients were identified. The overall conversion rate for MIE was 6.3%. Compared with completed MIE, patients requiring conversion to open esophagectomy had a significantly increased risk of 30-day mortality (risk ratio, 2.63; 95% confidence interval, 1.03 to 6.69) and experienced a variety of other postoperative complications. Patients requiring conversion to open esophagectomy during MIE also experienced worse perioperative outcomes when compared to patients who underwent planned open esophagectomy. Estimated surgical risk on the basis of the ACS NSQIP Surgical Risk Calculator was the only variable found to be independently associated with conversion from minimally invasive to open esophagectomy (risk ratio, 1.03; 95% confidence interval, 1.01 to 1.04, for each 10% increase in risk score). CONCLUSIONS: Unplanned conversion to open esophagectomy during MIE is associated with significantly greater morbidity and a 2.6-fold increased risk of death when compared with both completed MIE and planned open esophagectomy. The ACS NSQIP Surgical Risk Calculator may help identify patients preoperatively who are at higher risk for conversion to open esophagectomy during MIE.

An Electronically Delivered Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure With Reduced Ejection Fraction: The EPIC-HF Trial.

BACKGROUND: Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction. Without novel approaches to improve prescribing, the cumulative benefits of heart failure with reduced ejection fraction treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. METHODS: The EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction) trial randomized patients with heart failure with reduced ejection fraction from a diverse health system to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered electronically 1 week before, 3 days before, and 24 hours before a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to "make one positive change" in heart failure with reduced ejection fraction prescribing. The primary endpoint was the percentage of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days after, compared with usual care during the same period. RESULTS: EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient activation tools and 145 were controls. The median age of patients was 65 years; 29% were female, 11% were Black, 7% were Hispanic, and the median ejection fraction was 32%. Preclinic data revealed significant GDMT opportunities, with no patients on target doses of ß-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days after, 49.0% in the intervention and 29.7% in the control experienced an initiation or intensification of their GDMT (P=0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths and no significant differences in hospitalization or emergency department visits at 30 days between groups. CONCLUSIONS: A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03334188.

An Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial.

BACKGROUND: Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. HYPOTHESIS: Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies. DESIGN: The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with <1% of patients on optimal HFrEF medical therapy. SUMMARY: The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.

Prevalence and characteristics of HPV vaccine hesitancy among parents of adolescents across the US.

BACKGROUND: While many clinicians encounter parents or adolescents who refuse HPV vaccine, little is known about the prevalence of hesitancy for HPV vaccine nationally or its association with vaccination. METHODS: In April 2019, we surveyed families with adolescents 11-17 years using a national online panel (Knowledge Panel®) as the sampling frame. We assessed the prevalence of HPV vaccine hesitancy with the validated 9-item Vaccine Hesitancy Scale (VHS). We used multivariate analyses to assess demographic factors associated with HPV vaccine hesitancy. We also assessed practical barriers to receipt of HPV vaccine and the relationship between barriers and hesitancy. Finally, we evaluated the association between both HPV vaccine hesitancy and practical barriers on HPV vaccine receipt or refusal. RESULTS: 2,177 parents out of 4,185 sampled (52%) completed the survey, 2,020 qualified (lived with adolescent). Using a VHS cut-off score > 3 out of 5 points, 23% of US parents were hesitant about HPV vaccine. Hesitancy was lower among those with Hispanic ethnicity. At least one out of five parents disagreed that the HPV vaccine is beneficial for their adolescent, that the vaccine is effective, protects against HPV-related cancers, or that they followed their adolescent's health-care provider's recommendation about the vaccine. Many were concerned about vaccine side effects and the novelty of the vaccine. Adolescents living with vaccine-hesitant parents were less than one-third as likely to have received the vaccine (RR = 0.29, 95% CI 0.24, 0.35) or completed the vaccine series (RR = 0.29, 95% CI 0.23, 0.36), and were 6-fold more likely to have refused the vaccine because of parental vaccine-related concerns (RR = 6.09, 95% CI = 5.26, 7.04). Most practical barriers were independently associated with vaccine receipt but not with vaccine refusal. CONCLUSIONS: HPV vaccine hesitancy is common nationally and strongly related to both under-vaccination and vaccine refusal.

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.