Faculty Bibliography

IMPORTANCE/UNASSIGNED:Classification of persons with long COVID (LC) or post-COVID-19 condition must encompass the complexity and heterogeneity of the condition. Iterative refinement of the classification index for research is needed to incorporate newly available data as the field rapidly evolves. OBJECTIVE/UNASSIGNED:To update the 2023 research index for adults with LC using additional participant data from the Researching COVID to Enhance Recovery (RECOVER-Adult) study and an expanded symptom list based on input from patient communities. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Prospective, observational cohort study including adults 18 years or older with or without known prior SARS-CoV-2 infection who were enrolled at 83 sites in the US and Puerto Rico. Included participants had at least 1 study visit taking place 4.5 months after first SARS-CoV-2 infection or later, and not within 30 days of a reinfection. The study visits took place between October 2021 and March 2024. EXPOSURE/UNASSIGNED:SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Presence of LC and participant-reported symptoms. RESULTS/UNASSIGNED:A total of 13 647 participants (11 743 with known SARS-CoV-2 infection and 1904 without known prior SARS-CoV-2 infection; median age, 45 years [IQR, 34-69 years]; and 73% were female) were included. Using the least absolute shrinkage and selection operator analysis regression approach from the 2023 model, symptoms contributing to the updated 2024 index included postexertional malaise, fatigue, brain fog, dizziness, palpitations, change in smell or taste, thirst, chronic cough, chest pain, shortness of breath, and sleep apnea. For the 2024 LC research index, the optimal threshold to identify participants with highly symptomatic LC was a score of 11 or greater. The 2024 index classified 20% of participants with known prior SARS-CoV-2 infection and 4% of those without known prior SARS-CoV-2 infection as having likely LC (vs 21% and 5%, respectively, using the 2023 index) and 39% of participants with known prior SARS-CoV-2 infection as having possible LC, which is a new category for the 2024 model. Cluster analysis identified 5 LC subtypes that tracked quality-of-life measures. CONCLUSIONS AND RELEVANCE/UNASSIGNED:The 2024 LC research index for adults builds on the 2023 index with additional data and symptoms to help researchers classify symptomatic LC and its symptom subtypes. Continued future refinement of the index will be needed as the understanding of LC evolves.

BACKGROUND:Despite heightened risk of chronic health conditions, <20 % of childhood cancer survivors (CCS) receive guideline-recommended surveillance for late effects. Barriers include avoidance of reminders, lack of knowledge, and costs. The goal of the BRIDGES Study is to evaluate the effects of a multi-level, remote intervention on adherence to guideline-recommended surveillance among CCS by partnering with primary care providers (PCPs). METHODS:This ongoing study is a multi-site, two-arm, prospective, parallel design, 1:1 randomized controlled non-inferiority trial (N = 240; n = 120/group). Eligibility criteria are: cancer diagnosis at age < 21 years, 2.0-4.0 years post-cancer therapy, and no previous specialty survivorship clinic care. The intervention includes: 1) patient survivorship education via telehealth with a cancer center nurse, including discussion of patient's individualized survivorship care plan (SCP), 2) ongoing patient-tailored health education within the electronic health record's patient portal, 3) a structured interactive phone call between the cancer center nurse and PCP, including discussion of patient's SCP, and 4) an in-person PCP visit for survivorship care. Patients randomized to the comparison group are contacted to schedule an in-person visit at their cancer center-based survivorship clinic. Adherence to guideline-recommended surveillance tests (primary outcome) is assessed at 1-year post-randomization (primary follow-up time point) and 2-years post-randomization (for durability). Patient knowledge, self-efficacy, and activation; PCP knowledge and self-efficacy; and process outcomes are also assessed. CONCLUSION/CONCLUSIONS:Models of survivorship care that overcome existing barriers are needed. If efficacious, this scalable, remote intervention would be a valuable strategy to address barriers and bridge gaps in care to reach more CCS. CLINICAL TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov Identifier: NCT05448560.

IMPORTANCE/UNASSIGNED:The emergency department (ED) offers an opportunity to initiate palliative care for older adults with serious, life-limiting illness. OBJECTIVE/UNASSIGNED:To assess the effect of a multicomponent intervention to initiate palliative care in the ED on hospital admission, subsequent health care use, and survival in older adults with serious, life-limiting illness. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Cluster randomized, stepped-wedge, clinical trial including patients aged 66 years or older who visited 1 of 29 EDs across the US between May 1, 2018, and December 31, 2022, had 12 months of prior Medicare enrollment, and a Gagne comorbidity score greater than 6, representing a risk of short-term mortality greater than 30%. Nursing home patients were excluded. INTERVENTION/UNASSIGNED:A multicomponent intervention (the Primary Palliative Care for Emergency Medicine intervention) included (1) evidence-based multidisciplinary education; (2) simulation-based workshops on serious illness communication; (3) clinical decision support; and (4) audit and feedback for ED clinical staff. MAIN OUTCOME AND MEASURES/UNASSIGNED:The primary outcome was hospital admission. The secondary outcomes included subsequent health care use and survival at 6 months. RESULTS/UNASSIGNED:There were 98 922 initial ED visits during the study period (median age, 77 years [IQR, 71-84 years]; 50% were female; 13% were Black and 78% were White; and the median Gagne comorbidity score was 8 [IQR, 7-10]). The rate of hospital admission was 64.4% during the preintervention period vs 61.3% during the postintervention period (absolute difference, -3.1% [95% CI, -3.7% to -2.5%]; adjusted odds ratio [OR], 1.03 [95% CI, 0.93 to 1.14]). There was no difference in the secondary outcomes before vs after the intervention. The rate of admission to an intensive care unit was 7.8% during the preintervention period vs 6.7% during the postintervention period (adjusted OR, 0.98 [95% CI, 0.83 to 1.15]). The rate of at least 1 revisit to the ED was 34.2% during the preintervention period vs 32.2% during the postintervention period (adjusted OR, 1.00 [95% CI, 0.91 to 1.09]). The rate of hospice use was 17.7% during the preintervention period vs 17.2% during the postintervention period (adjusted OR, 1.04 [95% CI, 0.93 to 1.16]). The rate of home health use was 42.0% during the preintervention period vs 38.1% during the postintervention period (adjusted OR, 1.01 [95% CI, 0.92 to 1.10]). The rate of at least 1 hospital readmission was 41.0% during the preintervention period vs 36.6% during the postintervention period (adjusted OR, 1.01 [95% CI, 0.92 to 1.10]). The rate of death was 28.1% during the preintervention period vs 28.7% during the postintervention period (adjusted OR, 1.07 [95% CI, 0.98 to 1.18]). CONCLUSIONS AND RELEVANCE/UNASSIGNED:This multicomponent intervention to initiate palliative care in the ED did not have an effect on hospital admission, subsequent health care use, or short-term mortality in older adults with serious, life-limiting illness. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03424109.

PURPOSE/UNASSIGNED:We aimed to determine whether implementation of clinical decision support (CDS) tool integrated into the electronic health record of a multisite academic medical center increased the proportion of patients with AUA "high-risk" microscopic hematuria (MH) who receive guideline concordant evaluations. MATERIALS AND METHODS/UNASSIGNED:We conducted a two-arm cluster randomized quality improvement project in which 202 ambulatory sites from a large health system were randomized to either have their physicians receive at time of test results an automated CDS alert for patients with "high-risk" MH with associated recommendations for imaging and cystoscopy (intervention) or usual care (control). Primary outcome was met if a patient underwent both imaging and cystoscopy within 180 days from MH result. Secondary outcomes assessed individual completion of imaging, cystoscopy, or placement of imaging orders. RESULTS/UNASSIGNED:= .09). CONCLUSIONS/UNASSIGNED:Implementing an electronic health record-integrated CDS tool to promote evaluation of patients with high-risk MH did not lead to improvements in patient completion of a full guideline-concordant evaluation. The development of an algorithm to trigger a CDS alert was demonstrated to be feasible and effective. Further multilevel assessment of barriers to evaluation is necessary to continue to improve the approach to evaluating high-risk patients with MH.

IMPORTANCE/UNASSIGNED:A substantial number of individuals worldwide experience long COVID, or post-COVID condition. Other postviral and autoimmune conditions have a female predominance, but whether the same is true for long COVID, especially within different subgroups, is uncertain. OBJECTIVE/UNASSIGNED:To evaluate sex differences in the risk of developing long COVID among adults with SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This cohort study used data from the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER)-Adult cohort, which consists of individuals enrolled in and prospectively followed up at 83 sites in 33 US states plus Washington, DC, and Puerto Rico. Data were examined from all participants enrolled between October 29, 2021, and July 5, 2024, who had a qualifying study visit 6 months or more after their initial SARS-CoV-2 infection. EXPOSURE/UNASSIGNED:Self-reported sex (male, female) assigned at birth. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Development of long COVID, measured using a self-reported symptom-based questionnaire and scoring guideline at the first study visit that occurred at least 6 months after infection. Propensity score matching was used to estimate risk ratios (RRs) and risk differences (95% CIs). The full model included demographic and clinical characteristics and social determinants of health, and the reduced model included only age, race, and ethnicity. RESULTS/UNASSIGNED:Among 12 276 participants who had experienced SARS-CoV-2 infection (8969 [73%] female; mean [SD] age at infection, 46 [15] years), female sex was associated with higher risk of long COVID in the primary full (RR, 1.31; 95% CI, 1.06-1.62) and reduced (RR, 1.44; 95% CI, 1.17-1.77) models. This finding was observed across all age groups except 18 to 39 years (RR, 1.04; 95% CI, 0.72-1.49). Female sex was associated with significantly higher overall long COVID risk when the analysis was restricted to nonpregnant participants (RR, 1.50; 95%: CI, 1.27-1.77). Among participants aged 40 to 54 years, the risk ratio was 1.42 (95% CI, 0.99-2.03) in menopausal female participants and 1.45 (95% CI, 1.15-1.83) in nonmenopausal female participants compared with male participants. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this prospective cohort study of the NIH RECOVER-Adult cohort, female sex was associated with an increased risk of long COVID compared with male sex, and this association was age, pregnancy, and menopausal status dependent. These findings highlight the need to identify biological mechanisms contributing to sex specificity to facilitate risk stratification, targeted drug development, and improved management of long COVID.

In 2001, the Centers for Medicare and Medicaid Services established the New Technology Add-On Payment (NTAP) program to incentivize access to costly new technologies for Medicare beneficiaries. These technologies, authorized by the Food and Drug Administration (FDA), must demonstrate "substantial clinical improvement" when compared to existing technologies. However, in FY2021, the FDA introduced two expedited authorization pathways, allowing technologies with either designation to bypass the "substantial clinical improvement" criterion. We describe the services and payments associated with NTAPs following this policy change.

BACKGROUND:Patients hospitalized with COVID-19 can clinically deteriorate after a period of initial stability, making optimal timing of discharge a clinical and operational challenge. OBJECTIVE:To determine risks for post-discharge readmission and death among patients hospitalized with COVID-19. DESIGN/METHODS:Multicenter retrospective observational cohort study, 2020-2021, with 30-day follow-up. PARTICIPANTS/METHODS:Adults admitted for care of COVID-19 respiratory disease between March 2, 2020, and February 11, 2021, to one of 180 US hospitals affiliated with the HCA Healthcare system. MAIN MEASURES/METHODS:Readmission to or death at an HCA hospital within 30 days of discharge was assessed. The area under the receiver operating characteristic curve (AUC) was calculated using an internal validation set (33% of the HCA cohort), and external validation was performed using similar data from six academic centers associated with a hospital medicine research network (HOMERuN). KEY RESULTS/RESULTS:The final HCA cohort included 62,195 patients (mean age 61.9 years, 51.9% male), of whom 4704 (7.6%) were readmitted or died within 30 days of discharge. Independent risk factors for death or readmission included fever within 72 h of discharge; tachypnea, tachycardia, or lack of improvement in oxygen requirement in the last 24 h; lymphopenia or thrombocytopenia at the time of discharge; being ≤ 7 days since first positive test for SARS-CoV-2; HOSPITAL readmission risk score ≥ 5; and several comorbidities. Inpatient treatment with remdesivir or anticoagulation were associated with lower odds. The model's AUC for the internal validation set was 0.73 (95% CI 0.71-0.74) and 0.66 (95% CI 0.64 to 0.67) for the external validation set. CONCLUSIONS:This large retrospective study identified several factors associated with post-discharge readmission or death in models which performed with good discrimination. Patients 7 or fewer days since test positivity and who demonstrate potentially reversible risk factors may benefit from delaying discharge until those risk factors resolve.

Electronic health record (EHR)-embedded tools are known to improve prescribing of guideline-directed medical therapy (GDMT) for patients with heart failure. However, physicians may perceive EHR tools to be unhelpful, and may be therefore hesitant to implement these in their practice. We surveyed cardiologists about two effective EHR-tools to improve heart failure care, and they perceived the EHR tools to be easy to use, helpful, and improve the overall management of their patients with heart failure.