Psychosocial predictors of health behavior adherence in heart-failure patients with comorbid depression: a secondary analysis of the Hopeful Heart trial.

BACKGROUND: Depression affects 20-30% of individuals with heart failure (HF), and it is associated with worse health outcomes independent of disease severity. One potential explanation is the adverse impact of depression on HF patients' adherence to the health behaviors needed to self-manage their condition. The aim of this study is to identify characteristics associated with lower adherence in this population, which could help to recognize individuals at higher risk and eventually tailor health behavior interventions to their needs. METHODS: Using data from a randomized, controlled, collaborative care treatment trial in 629 patients with HF and comorbid depression, we performed mixed effects logistic regression analyses to examine the cross-sectional and prospective relationships between medical and psychosocial variables and health behavior adherence, including adherence to medications, a low-sodium diet, and physician appointments. RESULTS: In cross-sectional analyses, married marital status and higher physical health-related quality of life (HRQoL) were associated with greater overall adherence (compared to married, single Odds Ratio [OR] = 0.46, 95% Confidence Interval [CI] = 0.26-0.80; other OR = 0.60, CI = 0.38-0.94; p = .012. Physical HRQoL OR = 1.02, CI = 1.00-1.04, p = .047). Prospectively, greater levels of social support were associated with improved overall adherence one year later (OR = 1.04, 95% CI = 1.00-1.08, p = .037). Social support, HF symptom severity, race and ethnicity, and age were predictors of specific types of adherence. Neither depression nor optimism was significantly associated with adherence outcomes. CONCLUSIONS: These results provide important preliminary information about risk factors for poor adherence in patients with both HF and depression, which could, in turn, contribute to the development of interventions to promote adherence in this high-risk population. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02044211 ; registered 1/21/2014.

Active surveillance pharmacovigilance for Clostridioides difficile infection and gastrointestinal bleeding: an analytic framework based on case-control studies.

BACKGROUND: Active surveillance pharmacovigilance is an emerging approach to identify medications with unanticipated effects. We previously developed a framework called pharmacopeia-wide association studies (PharmWAS) that limits false positive medication associations through high-dimensional confounding adjustment and set enrichment. We aimed to assess the transportability and generalizability of the PharmWAS framework by using medical claims data to reproduce known medication associations with Clostridioides difficile infection (CDI) or gastrointestinal bleeding (GIB). METHODS: We conducted case-control studies using Optum's de-identified Clinformatics Data Mart Database of individuals enrolled in large commercial and Medicare Advantage health plans in the United States. Individuals with CDI (from 2010 to 2015) or GIB (from 2010 to 2021) were matched to controls by age and sex. We identified all medications utilized prior to diagnosis and analysed the association of each with CDI or GIB using conditional logistic regression adjusted for risk factors for the outcome and a high-dimensional propensity score. FINDINGS: For the CDI study, we identified 55,137 cases, 220,543 controls, and 290 medications to analyse. Antibiotics with Gram-negative spectrum, including ciprofloxacin (aOR 2.83), ceftriaxone (aOR 2.65), and levofloxacin (aOR 1.60), were strongly associated. For the GIB study, we identified 450,315 cases, 1,801,260 controls, and 354 medications to analyse. Antiplatelets, anticoagulants, and non-steroidal anti-inflammatory drugs, including ticagrelor (aOR 2.81), naproxen (aOR 1.87), and rivaroxaban (aOR 1.31), were strongly associated. INTERPRETATION: These studies demonstrate the generalizability and transportability of the PharmWAS pharmacovigilance framework. With additional validation, PharmWAS could complement traditional passive surveillance systems to identify medications that unexpectedly provoke or prevent high-impact conditions. FUNDING: U.S. National Institute of Diabetes and Digestive and Kidney Diseases.

Access to Specialty Care for Commercially Insured Youths With Type 1 and Type 2 Diabetes.

Importance: Youths with type 2 diabetes are at higher risk for complications compared with peers with type 1 diabetes, though few studies have evaluated differences in access to specialty care. Objective: To compare claims with diabetes specialists for youths with type 1 vs type 2 diabetes and the association between specialist claims with multidisciplinary and acute care utilization. Design, Setting, and Participants: This cross-sectional study used Optum Clinformatics Data Mart commercial claims. Individuals included in the study were youths younger than 19 years with type 1 or 2 diabetes as determined by a validated algorithm and prescription claims. Data were collected for youths with at least 80% enrollment in a commercial health plan from December 1, 2018, to December 31, 2019. Statistical analysis was performed from September 2022 to January 2024. Main Outcomes and Measures: The primary outcome was the number of ambulatory claims from an endocrine and/or diabetes physician or advanced practice clinician associated with a diabetes diagnosis code; secondary outcomes included multidisciplinary and acute care claims. Results: Claims were analyzed for 4772 youths (mean [SD] age, 13.6 [3.7] years; 4300 [90.1%] type 1 diabetes; 472 [9.9%] type 2 diabetes; 2465 [51.7%] male; 128 [2.7%] Asian, 303 [6.4] Black or African American, 429 [9.0%] Hispanic or Latino, 3366 [70.5%] non-Hispanic White, and 546 [11.4%] unknown race and ethnicity). Specialist claims were lower in type 2 compared with type 1 diabetes (incidence rate ratio [IRR], 0.61 [95% CI, 0.52-0.72]; P < .001) in propensity score-weighted analyses. The presence of a comorbidity was associated with increased specialist claims for type 1 diabetes (IRR, 1.07 [95% CI, 1.03-1.10]) and decreased claims for type 2 diabetes (IRR, 0.77 [95% CI, 0.67-0.87]). Pooling diagnosis groups and adjusted for covariates, each additional specialist claim was associated with increased odds of a claim with a diabetes care and education specialist (odds ratio [OR], 1.31 [95% CI, 1.25-1.36]), dietitian (OR, 1.14 [95% CI, 1.09-1.19]), and behavioral health clinician (OR, 1.16 [95% CI, 1.12-1.20]). For acute care claims, each additional specialist claim was associated with increased odds of admission (OR, 1.17 [95% CI, 1.11-1.24]) but not for emergency claims (OR, 1.03 [95% CI, 0.98-1.82]). Conclusions and Relevance: This cross-sectional study found that youths with type 2 diabetes were significantly less likely to have specialist claims despite insurance coverage, indicating other barriers to care, which may include medical complexity. Access to diabetes specialists influences engagement with multidisciplinary services. The association between increasing ambulatory clinician services and admissions suggests high utilization by a subgroup of patients at greater risk for poor outcomes.

Drug Shortages Prior to and During the COVID-19 Pandemic.

Importance: Drug shortages are a chronic and worsening issue that compromises patient safety. Despite the destabilizing impact of the COVID-19 pandemic on pharmaceutical production, it remains unclear whether issues affecting the drug supply chain were more likely to result in meaningful shortages during the pandemic. Objective: To estimate the proportion of supply chain issue reports associated with drug shortages overall and with the COVID-19 pandemic. Design, Setting, and Participants: This longitudinal cross-sectional study used data from the IQVIA Multinational Integrated Data Analysis database, comprising more than 85% of drug purchases by US pharmacies from wholesalers and manufacturers, from 2017 to 2021. Data were analyzed from January to May 2023. Exposure: Presence of a supply chain issue report to the US Food and Drug Administration or the American Society of Health-Systems Pharmacists (ASHP). Main Outcomes and Measures: The main outcome was drug shortage, defined as at least 33% decrease in units purchased within 6 months of a supply chain issue report. Random-effects logistic regression models compared the marginal odds of shortages for drugs with vs without reports. Interaction terms assessed heterogeneity prior to vs during the COVID-19 pandemic and by drug characteristics (formulation, age, essential medicine status, clinician- vs self-administered, sales volume, and number of manufacturers). Results: A total of 571 drugs exposed to 731 supply chain issue reports were matched to 7296 comparison medications with no reports. After adjusting for drug characteristics, 13.7% (95% CI, 10.4%-17.8%) of supply chain issue reports were associated with subsequent drug shortages vs 4.1% (95% CI, 3.6%-4.8%) of comparators (marginal odds ratio [mOR], 3.7 [95% CI, 2.6-5.1]). Shortages increased among both drugs with and without reports in February to April 2020 (34.2% of drugs with supply chain issue reports and 9.5% of comparison drugs; mOR, 4.9 [95% CI, 2.1-11.6]), and then decreased after May 2020 (9.8% of drugs with reports and 3.6% of comparison drugs; mOR, 2.9 [95% CI, 1.6-5.3]). Significant associations were identified by formulation (parenteral mOR, 1.9 [95% CI, 1.1-3.2] vs oral mOR, 5.4 [95% CI, 3.3-8.8]; P for interaction = .008), WHO essential medicine status (essential mOR, 2.2 [95% CI, 1.3-5.2] vs nonessential mOR, 4.6 [95% CI, 3.2-6.7]; P = .02), and for brand-name vs generic status (brand-name mOR, 8.1 [95% CI, 4.0-16.0] vs generic mOR, 2.4 [95% CI, 1.7-3.6]; P = .002). Conclusions and Relevance: In this national cross-sectional study, supply chain issues associated with drug shortages increased at the beginning of the COVID-19 pandemic. Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.

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

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

Characteristics differentiating problem representation synthesis between novices and experts.

BACKGROUND: Formulating a thoughtful problem representation (PR) is fundamental to sound clinical reasoning and an essential component of medical education. Aside from basic structural recommendations, little consensus exists on what characterizes high-quality PRs. OBJECTIVES: To elucidate characteristics that distinguish PRs created by experts and novices. METHODS: Early internal medicine residents (novices) and inpatient teaching faculty (experts) from two academic medical centers were given two written clinical vignettes and were instructed to write a PR and three-item differential diagnosis for each. Deductive content analysis described the characteristics comprising PRs. An initial codebook of characteristics was refined iteratively. The primary outcome was differences in characteristic frequencies between groups. The secondary outcome was characteristics correlating with diagnostic accuracy. Mixed-effects regression with random effects modeling compared case-level outcomes by group. RESULTS: Overall, 167 PRs were analyzed from 30 novices and 54 experts. Experts included 0.8 fewer comorbidities (p < .01) and 0.6 more examination findings (p = .01) than novices on average. Experts were less likely to include irrelevant comorbidities (odds ratio [OR] = 0.4, 95% confidence interval [CI] = 0.2-0.8) or a diagnosis (OR = 0.3, 95% CI = 0.1-0.8) compared with novices. Experts encapsulated clinical data into higher-order terms (e.g., sepsis) than novices (p < .01) while including similar numbers of semantic qualifiers (SQs). Regardless of expertise level, PRs following a three-part structure (e.g., demographics, temporal course, and clinical syndrome) and including temporal SQs were associated with diagnostic accuracy (p < .01). CONCLUSIONS: Compared with novices, expert PRs include less irrelevant data and synthesize information into higher-order concepts. Future studies should determine whether targeted educational interventions for PRs improve diagnostic accuracy.

Internal Medicine Residents' Perceptions of Their Continuity Clinic Training.

OBJECTIVES: Internal Medicine (IM) residents have reported dissatisfaction with continuity clinic (CC) training, which may contribute to the increasing shortage of primary care physicians. Studies show balancing inpatient and outpatient duties as a driver of dissatisfaction, but few studies have compared CC with inpatient (IP) training, following transition to an X + Y model, or assessed the impact of show rates, continuity, and telemedicine use on resident perceptions. The aim of this study was to adapt a validated survey to compare residents' perceptions of their CC with their inpatient medicine training and examine the impact of objective clinic measures on training. METHODS: This quantitative cross-sectional study included a survey that was sent to 152 residents at an academic IM program in May-June 2021. Clinic measures such as show versus no-show rates, continuity with the residents' own patients, and visit modality were obtained through the electronic health records at Veterans Affairs and non-Veterans Affairs CCs. RESULTS: The survey response rate was 78% (118/152). Residents were more satisfied with inpatient general medicine rotations than their CC experience (4.5 vs 3.3 on a 5-point scale, P < 0.001). Residents were more likely to pursue a profession in inpatient IM than in primary care (3.7 vs 2.3, P < 0.001). No correlation was found between higher show rates, continuity with patients, or proportion of visits conducted through telemedicine and resident satisfaction with CC. CONCLUSIONS: This study aligns with previous findings of IM resident dissatisfaction with CC training while adding a side-by-side comparison to inpatient training and including objective CC data. We identified new areas for improvement of CC training, including residents' medical knowledge through review of quality metrics, making CC representative of real-world practice, and mentorship from faculty.

Obesity-Specific Considerations for Assessing Gait with Inertial Measurement Unit-Based vs. Optokinetic Motion Capture.

Adults with obesity experience high rates of disability and rapid functional decline. Identifying movement dysfunction early can direct intervention and disrupt disability development; however, subtle changes in movement are difficult to detect with the naked eye. This study evaluated how a portable, inertial measurement unit (IMU)-based motion capture system compares to a laboratory-based optokinetic motion capture (OMC) system for evaluating gait kinematics in adults with obesity. Ten adults with obesity performed overground walking while equipped with the OMC and IMU systems. Fifteen gait cycles for each participant were extracted for the 150 total cycles analyzed. Kinematics were compared between OMC and IMU across the gait cycles (coefficient of multiple correlations), at clinically significant time points (interclass correlations), and over clinically relevant ranges (Bland-Altman plots). Sagittal plane kinematics were most similar between systems, especially at the knee. Sagittal plane joint angles at clinically meaningful timepoints were poorly associated except for ankle dorsiflexion at heel strike (ρ = 0.38) and minimum angle (ρ = 0.83). All motions except for ankle dorsiflexion and hip abduction had >5° difference between systems across the range of angles measured. While IMU-based motion capture shows promise for detecting subtle gait changes in adults with obesity, more work is needed before this method can replace traditional OMC. Future work should explore standardization procedures to improve consistency of IMU motion capture performance.

Predictors of Use and Drop Out From a Web-Based Cognitive Behavioral Therapy Program and Health Community for Depression and Anxiety in Primary Care Patients: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: A previously reported study examined the treatment of primary care patients with at least moderate severity depressive or anxiety symptoms via an evidence-based computerized cognitive behavioral therapy (CCBT) program (Beating the Blues) and an online health community (OHC) that included a moderated internet support group. The 2 treatment arms proved to be equally successful at 6-month follow-up. OBJECTIVE: Although highly promising, e-mental health treatment programs have encountered high rates of noninitiation, poor adherence, and discontinuation. Identifying ways to counter these tendencies is critical for their success. To further explore these issues, this study identified the primary care patient characteristics that increased the chances patients would not initiate the use of an intervention, (ie, not try it even once), initiate use, and go on to discontinue or continue to use an intervention. METHODS: The study had 3 arms: one received access to CCBT (n=301); another received CCBT plus OHC (n=302), which included a moderated internet support group; and the third received usual care (n=101). Participants in the 2 active intervention arms of the study were grouped together for analyses of CCBT use (n=603) because both arms had access to CCBT, and there were no differences in outcomes between the 2 arms. Analyses of OHC use were based on 302 participants who were randomized to that arm. RESULTS: Several baseline patient characteristics were associated with failure to initiate the use of CCBT, including having worse physical health (measured by the Short Form Health Survey Physical Components Score, P=.01), more interference from pain (by the Patient-Reported Outcomes Measurement Information System Pain Interference score, P=.048), less formal education (P=.02), and being African American or another US minority group (P=.006). Characteristics associated with failure to initiate use of the OHC were better mental health (by the Short Form Health Survey Mental Components Score, P=.04), lower use of the internet (P=.005), and less formal education (P=.001). Those who initiated the use of the CCBT program but went on to complete less of the program had less formal education (P=.01) and lower severity of anxiety symptoms (P=.03). CONCLUSIONS: This study found that several patient characteristics predicted whether a patient was likely to not initiate use or discontinue the use of CCBT or OHC. These findings have clear implications for actionable areas that can be targeted during initial and ongoing engagement activities designed to increase patient buy-in, as well as increase subsequent use and the resulting success of eHealth programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01482806; https://clinicaltrials.gov/study/NCT01482806.

Development and Pilot Testing of a Longitudinal Skills-Based Feedback and Conflict Resolution Curriculum for Internal Medicine Residents.

PROBLEM: Physicians in training are responsible for leading clinical teams, coordinating interdisciplinary management, navigating conflict, and supervising and giving feedback to junior learners. Giving feedback and resolving conflict are key leadership skills for internal medicine (IM) residents, many of whom desire additional training. Although these skills are integral to successful leadership for physicians in training, residents receive little explicit education and existing curricula have not established best practices for skill acquisition. APPROACH: Study authors designed a pilot longitudinal, skills-based curriculum to teach first- through third-year IM residents at the University of Pittsburgh how to give formative feedback and engage in conflict resolution. From February to May 2021, authors delivered a series of interactive lectures utilizing frameworks, workplace-based scenarios, skills practice, and discussion. Skills transfer was evaluated with novel pre- and postcurriculum objective structured clinical examinations (OSCEs) wherein participants played the role of senior resident. Each OSCE involved 2 feedback and 2 conflict resolution stations. OSCE performances were evaluated using an author-created checklist with a 1-4 rating scale. The exposure group comprised post-OSCE participants who attended the curriculum. Data were analyzed using a mixed effects regression model. OUTCOMES: Thirty-six residents participated in curriculum evaluation, and 23 were included in postcurriculum data analysis. Within feedback, the skill "explores feedback content" significantly improved for exposure group participants (precurriculum median, 2.64; postcurriculum, 3.24; P < .05). For conflict resolution, among the exposure group, the skill "identifies a common goal, value, or purpose" significantly improved (pre, 3.10; post, 3.62; P < .05). NEXT STEPS: This curriculum and evaluation can serve as a stepping stone for further evidence-based leadership frameworks, curricula, and evaluations developed specifically for physicians within their unique leadership roles. The feedback and conflict resolution frameworks used in this curriculum can be applied to various medical specialties, with specialty-relevant scenario adaptations for interactive skills practice.

Team Functioning and Performance in Child Advocacy Center Multidisciplinary Teams.

The quality of teamwork in Child Advocacy Center (CAC) multidisciplinary teams is likely to affect the extent to which the CAC model improves outcomes for children and families. This study examines associations between team functioning and performance in a statewide sample of CAC teams. Multidisciplinary team members (N = 433) from 21 CACs completed measures of affective, behavioral, and cognitive team functioning. Team performance was assessed with three measures: team member ratings of overall performance, ratings of mental health screening/referral frequency, and caregiver satisfaction surveys. Linear mixed models and regression analyses tested associations between team functioning and performance. Affective team functioning (i.e., liking, trust, and respect; psychological safety) and cognitive team functioning (i.e., clear direction) were significantly associated with team members' ratings of overall performance. Behavioral team functioning (i.e., coordination) and cognitive team functioning were significantly associated with mental health screening/referral frequency. Team functioning was not associated with caregiver satisfaction with CAC services. Aspects of team functioning were associated with team members' perceptions of overall performance and mental health screening/referral frequency, but not caregiver satisfaction. Understanding associations between team functioning and performance in multidisciplinary teams can inform efforts to improve service quality in CACs and other team-based service settings.

A Retrospective Cohort Study of the 2018 Angiotensin Receptor Blocker Recalls and Subsequent Drug Shortages in Patients With Hypertension.

BACKGROUND: Valsartan was recalled by the US Food and Drug Administration in July 2018 for carcinogenic impurities, resulting in a drug shortage and management challenges for valsartan users. The influence of the valsartan recall on clinical outcomes is unknown. We compared the risk of adverse events between hypertensive patients using valsartan and a propensity score-matched group using nonrecalled angiotensin receptor blockers and angiotensin-converting enzyme inhibitors. METHODS AND RESULTS: We used Optum's deidentified Clinformatics Datamart (July 2017-January 2019). Hypertensive patients who received valsartan or nonrecalled angiotensin receptor blockers/angiotensin-converting enzyme inhibitors for 1 year before and on the recall date were compared. Primary outcomes were measured in the 6 months following the recall and included: (1) a composite measure of all-cause hospitalization, all-cause emergency department visit, and all-cause urgent care visit, and (2) a composite cardiac event measure of hospitalizations for acute myocardial infarction and hospitalizations/emergency department visits/urgent care visits for stroke/transient ischemic attack, heart failure, or hypertension. We compared the risk of outcomes between treatment groups using Cox proportional hazard models. Of the hypertensive patients, 76 934 received valsartan, and 509 472 received a nonrecalled angiotensin receptor blocker/angiotensin-converting enzyme inhibitor. Valsartan use at the time of recall was associated with a higher risk of all-cause hospitalization, emergency department use, or urgent care use (hazard ratio [HR], 1.02 [95% CI, 1.00-1.04]) and the composite of cardiac events (HR, 1.22 [95% CI, 1.15-1.29]) within 6 months after the recall. CONCLUSIONS: The valsartan recall and shortage affected hypertensive patients. Local- and national-level systems need to be enhanced to protect patients from drug shortages by providing safe and reliable medication alternatives.

Socioeconomic status and healthcare utilization disparities among children with epilepsy in the United States: Results from a nationally representative sample.

Epilepsy affects 1% of the US population. Healthcare disparities are well-studied among adults with epilepsy but less so among children. We examined whether children with epilepsy (1) have lower income than or (2) utilize the emergency department (ED) differently from children without epilepsy, and (3) if income moderates ED utilization. Data from the 2016-2019 National Survey of Children's Health were used to identify children with active "epilepsy or seizure disorder". Children with versus without epilepsy were compared. Income and ED visits were modeled with logistic and Poisson regressions. This analysis included 131,326 children; 835 were diagnosed with epilepsy. Estimated population prevalence of epilepsy was 0.6%. Children from higher-income-households were less likely to have epilepsy (aOR: 0.7). Children with epilepsy were more likely to visit EDs (aOR = 10.2), see healthcare professionals (aOR: 2.7), and receive care from specialists (aOR: 10.3). Income moderated the relationship between having epilepsy and ED visits. 7.7% of children with epilepsy did not receive needed healthcare. Some barriers were acquiring appointments (aOR: 3.9) and transportation (aOR: 4.7). In conclusion, children with epilepsy were more likely than children without epilepsy to live in lower-income-households, visit EDs, see healthcare professionals, and not receive needed healthcare. Barrier-specific policy interventions may improve medical access for children with epilepsy.

Patterns of Telemedicine Use and Glycemic Outcomes of Endocrinology Care for Patients With Type 2 Diabetes.

Importance: Telemedicine can increase access to endocrinology care for people with type 2 diabetes (T2D), but patterns of use and outcomes of telemedicine specialty care for adults with T2D beyond initial uptake in 2020 are not known. Objective: To evaluate patterns of telemedicine use and their association with glycemic control among adults with varying clinical complexity receiving endocrinology care for T2D. Design, Setting, and Participants: Retrospective cohort study in a single large integrated US health system. Participants were adults who had a telemedicine endocrinology visit for T2D from May to October 2020. Data were analyzed from June 2022 to October 2023. Exposure: Patients were followed up through May 2022 and assigned to telemedicine-only, in-person, or mixed care (both telemedicine and in-person) cohorts according to visit modality. Main Outcomes and Measures: Multivariable regression models were used to estimate hemoglobin A1c (HbA1c) change at 12 months within each cohort and the association of factors indicating clinical complexity (insulin regimen and cardiovascular and psychological comorbidities) with HbA1c change across cohorts. Subgroup analysis was performed for patients with baseline HbA1c of 8% or higher. Results: Of 11 498 potentially eligible patients, 3778 were included in the final cohort (81 Asian participants [2%], 300 Black participants [8%], and 3332 White participants [88%]); 1182 used telemedicine only (mean [SD] age 57.4 [12.9] years; 743 female participants [63%]), 1049 used in-person care (mean [SD] age 63.0 [12.2] years; 577 female participants [55%]), and 1547 used mixed care (mean [SD] age 60.7 [12.5] years; 881 female participants [57%]). Among telemedicine-only patients, there was no significant change in adjusted HbA1c at 12 months (-0.06%; 95% CI, -0.26% to 0.14%; P = .55) while in-person and mixed cohorts had improvements of 0.37% (95% CI, 0.15% to 0.59%; P < .001) and 0.22% (95% CI, 0.07% to 0.38%; P = .004), respectively. Patients with a baseline HbA1c of 8% or higher had a similar pattern of glycemic outcomes. For patients prescribed multiple daily injections vs no insulin, the 12-month estimated change in HbA1c was 0.25% higher (95% CI, 0.02% to 0.47%; P = .03) for telemedicine vs in-person care. Comorbidities were not associated with HbA1c change in any cohort. Conclusions and Relevance: In this cohort study of adults with T2D receiving endocrinology care, patients using telemedicine alone had inferior glycemic outcomes compared with patients who used in-person or mixed care. Additional strategies may be needed to support adults with T2D who rely on telemedicine alone to access endocrinology care, especially for those with complex treatment or elevated HbA1c.

Comparisons of school-day glycemia in different settings for children with type 1 diabetes using continuous glucose monitoring.

Objective: Using continuous glucose monitoring (CGM), we examined patterns in glycemia during school hours for children with type 1 diabetes, exploring differences between school and non-school time. Methods: We conducted a retrospective analysis of CGM metrics in children 7-12 years (n=217, diabetes duration 3.5±2.5 years, hemoglobin A1c 7.5±0.8%). Metrics were obtained for weekday school hours (8 AM to 3 PM) during four weeks in fall 2019. Two comparison settings included weekend (fall 2019) and weekday (spring 2020) data when children had transitioned to virtual school due to COVID-19. We used multilevel mixed models to examine factors associated with time in range (TIR) and compare glycemia between in-school, weekends, and virtual school. Results: Though CGM metrics were clinically similar across settings, TIR was statistically higher, and time above range (TAR), mean glucose, and standard deviation (SD) lower, for weekends and virtual school (p<0.001). Hour and setting exhibited a significant interaction for several metrics (p<0.001). TIR in-school improved from a mean of 40.9% at the start of the school day to 58.0% later in school, with a corresponding decrease in TAR. TIR decreased on weekends (60.8 to 50.7%) and virtual school (62.2 to 47.8%) during the same interval. Mean glucose exhibited a similar pattern, though there was little change in SD. Younger age (p=0.006), lower hemoglobin A1c (p<0.001), and insulin pump use (p=0.02) were associated with higher TIR in-school. Conclusion: Although TIR was higher for weekends and virtual school, glycemic metrics improve while in-school, possibly related to beneficial school day routines.

Predictors of 1-year enteral autonomy in children with intestinal failure: A descriptive retrospective cohort study.

INTRODUCTION: The International Intestinal Failure Registry (IIFR) is an international consortium to study intestinal failure (IF) outcomes in a large contemporary pediatric cohort. We aimed to identify predictors of early (1-year) enteral autonomy. METHODS: We included IIFR pilot phase patients. IF was defined by a parenteral nutrition need for at least 60 days due to a primary gastrointestinal etiology. The primary outcome was time to enteral autonomy achievement. We built a mixed-effects Weibull accelerated failure time model with random effects by center to analyze variables associated with enteral autonomy achievement with a primary outcome of time ratio (TR). RESULTS: We included 189 patients (82% with short bowel syndrome) representing 11 international centers. Cumulative incidence of early enteral autonomy was 51.6%, and death was 6.5%. In multivariable analysis, ostomy presence (TR, 2.63; 95% CI, 1.41-4.90) was associated with increased time to enteral autonomy achievement, and Asian/Indian (TR, 0.28; 95% CI, 0.10-0.81) and Pacific Islander race (TR, 0.34; 95% CI, 0.13-0.90) were associated with decreased time to enteral autonomy achievement. In a second model in the subset with measured percentage of bowel length remaining, ostomy presence (TR, 4.21; 95% CI, 1.90-9.33) was associated with increased time to enteral autonomy achievement, whereas greater percentage of bowel remaining (TR, 0.96; 95% CI, 0.94-0.98) was associated with decreased time to enteral autonomy achievement. CONCLUSIONS: Minimizing bowel resection at initial surgery and establishing bowel continuity by ostomy reversal can effectively decrease the time to early enteral autonomy achievement in children with IF.

Recombinant von Willebrand factor and tranexamic acid for heavy menstrual bleeding in patients with mild and moderate von Willebrand disease in the USA (VWDMin): a phase 3, open-label, randomised, crossover trial.

BACKGROUND: Heavy menstrual bleeding occurs in 80% of women with von Willebrand disease and is associated with iron deficiency and poor response to current therapies. International guidelines indicate low certainty regarding effectiveness of hormonal therapy and tranexamic acid. Although von Willebrand factor (VWF) concentrate is approved for bleeds, no prospective trials guide its use in heavy menstrual bleeding. We aimed to compare recombinant VWF with tranexamic acid for reducing heavy menstrual bleeding in patients with von Willebrand disease. METHODS: VWDMin, a phase 3, open-label, randomised crossover trial, was done in 13 haemophilia treatment centres in the USA. Female patients aged 13-45 years with mild or moderate von Willebrand disease, defined as VWF ristocetin cofactor less than 0·50 IU/mL, and heavy menstrual bleeding, defined as a pictorial blood assessment chart (PBAC) score more than 100 in one of the past two cycles were eligible for enrolment. Participants were randomly assigned (1:1) to two consecutive cycles each of intravenous recombinant VWF, 40 IU/kg over 5-10 min on day 1, and oral tranexamic acid 1300 mg three times daily on days 1-5, the order determined by randomisation. The primary outcome was a 40-point reduction in PBAC score by day 5 after two cycles of treatment. Efficacy and safety were analysed in all patients with any post-baseline PBAC scores. The trial was stopped early due to slow recruitment on Feb 15, 2022, by a data safety monitoring board request, and was registered at ClinicalTrials.gov, NCT02606045. FINDINGS: Between Feb 12, 2019, and Nov 16, 2021, 39 patients were enrolled, 36 of whom completed the trial (17 received recombinant VWF then tranexamic acid and 19 received tranexamic acid then recombinant VWF). At the time of this unplanned interim analysis (data cutoff Jan 27, 2022), median follow-up was 23·97 weeks (IQR 21·81-28·14). The primary endpoint was not met, neither treatment corrected PBAC score to the normal range. Median PBAC score was significantly lower after two cycles with tranexamic acid than with recombinant VWF (146 [95% CI 117-199] vs 213 [152-298]; adjusted mean treatment difference 46 [95% CI 2-90]; p=0·039). There were no serious adverse events or treatment-related deaths and no grade 3-4 adverse events. The most common grade 1-2 adverse events were mucosal bleeding (four [6%] patients during tranexamic acid treatment vs zero during recombinant VWF treatment) and other bleeding (four [6%] vs two [3%]). INTERPRETATION: These interim data suggest that recombinant VWF is not superior to tranexamic acid in reducing heavy menstrual bleeding in patients with mild or moderate von Willebrand disease. These findings support discussion of treatment options for heavy menstrual bleeding with patients based on their preferences and lived experience. FUNDING: National Heart Lung Blood Institute (National Institutes of Health).

Evaluation of Out-of-Pocket Costs and Treatment Intensification With an SGLT2 Inhibitor or GLP-1 RA in Patients With Type 2 Diabetes and Cardiovascular Disease.

Importance: The latest guidelines continue to recommend sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for patients with type 2 diabetes (T2D) and established cardiovascular disease (CVD). Despite this, overall use of these 2 drug classes has been suboptimal. Objective: To assess the association of high out-of-pocket (OOP) costs and the initiation of an SGLT2 inhibitor or GLP-1 RA among adults with T2D and established CVD who are treated with metformin-treated. Design, Setting, and Participants: This retrospective cohort study used 2017 to 2021 data from the Optum deidentified Clinformatics Data Mart Database. Each individual in the cohort was categorized into quartiles of OOP costs for a 1-month supply of SGLT2 inhibitor and GLP-1 RA based on their health plan assignment. Data were analyzed from April 2021 to October 2022. Exposures: OOP cost for SGLT2 inhibitors and GLP-1 RA. Main Outcomes and Measures: The primary outcome was treatment intensification, defined as a new dispensing (ie, initiation) of either an SGLT2 inhibitor or GLP-1 RA, among patients with T2D previously treated with metformin monotherapy. For each drug class separately, Cox proportional hazards models were used to adjust for demographic, clinical, plan, clinician, and laboratory characteristics to estimate the hazard ratios of treatment intensification comparing the highest vs the lowest quartile of OOP costs. Results: Our cohort included 80 807 adult patients (mean [SD] age, 72 [9.5] years, 45 129 [55.8%] male; 71 128 [88%] were insured with Medicare Advantage) with T2D and established CVD on metformin monotherapy. Patients were followed for a median (IQR) of 1080 days (528 to 1337). The mean (SD) of OOP costs in the highest vs lowest quartile was $118 [32] vs $25 [12] for GLP-1 RA, and $91 [25] vs $23 [9] for SGLT2 inhibitors. Compared with patients in plans with the lowest quartile (Q1) of OOP costs, patients in plans with the highest quartile (Q4) of costs were less likely to initiate a GLP-1 RA (adjusted HR, 0.87 [95% CI, 0.78 to 0.97]) or an SGLT2 inhibitor (adjusted HR, 0.80 [95% CI, 0.73 to 0.88]). The median (IQR) number of days to initiating a GLP-1 RA was 481 (207-820) days in Q1 and 556 (237-917) days in Q4 of OOP costs and 520 (193-876) days in Q1 vs 685 (309-1017) days in Q4 for SGLT2 inhibitors. Conclusions and Relevance: In this cohort study of more than 80 000 older adults with T2D and established CVD covered by Medicare Advantage and commercial plans, those in the highest quartile of OOP cost were 13% and 20% less likely to initiate a GLP-1 RA or SGLT2 inhibitor, respectively, when compared with those in the lowest quartile of OOP costs.

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

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