Hollnagel, Fauzia

Objective: Patients with inflammatory bowel disease (IBD) are commonly treated with immunosuppressive therapies that increase the risk for infections, including hepatitis B (HepB) virus. Adult patients with IBD have suboptimal seroprotection rates after vaccination with a 3-dose recombinant recombinant HepB vaccine. Heplisav-B is an adjuvanted 2-dose HepB series that is more immunogenic in the general adult population. Herein, we evaluated the immunogenicity of Heplisav-B in adult patients with IBD. Patients and Methods: We conducted a prospective observational study of adult patients with IBD who were not seroprotected to HepB virus and received a Heplisav-B series with postimmunization HepB surface antibody (anti-HBs) serologic testing. Postimmunization anti-HBs ≥10 IU/mL was considered seroprotection. The primary outcome was the rate of seroprotection. Secondary outcomes were rates of seroprotection in different age groups, those on immunosuppressive therapy, and previous HepB vaccine nonresponders using a univariate analysis. Results: Eighty-five patients met the inclusion criteria with the majority (72%) achieving seroprotection with a median anti-HBs level of 48.7 IU/mL and 28 patients (33%) having an anti-HBs level >100 IU/mL. Those on immunosuppressive therapy [49 (58%), 18 nonresponders, odds ratio: 0.34, 95% CI: 0.12-0.99] and primary nonresponders to a previous HepB series [22 (26%), 11 nonresponders, odds ratio: 0.26, 95% CI: 0.09-0.73] were less likely to achieve seroprotection. Seven patients who did not respond received a third dose of Heplisav-B, and 2 achieved seroprotection. Conclusions: Heplisav-B achieved higher rates of seroprotection than those seen with 3-dose recombinant HepB vaccines in patients with IBD and may be the preferred option.

11128 Background: To improve documentation quality in Medical Onc outpatient clinics, a standardized template was created. In this template we embedded: 1. An Epic SmartForm to collect structured data (SD) about patient, disease, and response status at each encounter. Minimal Common Oncology Data Elements (mCODE) compatible SD elements were used to enhance interoperability. 2. Several clinically impactful quality metrics (QM) selected based on the Quality Onc Practice Initiative (QOPI) guidelines. In this analysis, we aim to assess how template use impacted documentation quality. Methods: 113,376 outpatient encounters occurred between 01/2018 – 12/2022 (41 providers: 35 physicians, 6 APPs). The template go live was 3/19/2019. 2,520 randomly selected encounters were manually reviewed. Distinct documentation of 8 items served as QMs (Table). Of note, using the template was voluntary and data entry in the embedded form is not mandated. Documentation of each QM was compared between notes authored with/without template. For each note, a completeness score was calculated based on total number of QMs present/note. Categorical comparisons were made using chi-squared or Fisher’s exact tests. Numerical/continuous values were summarized using means and standard deviations. A template “user” was defined as a provider using the template in >10% of encounters after go live. This QI project was exempted by IRB. Results: 154/2520 encounters were excluded after manual review (visits not for solid tumor malignancy). The template was used in 38.7% (917/2366) of the reviewed notes. Cancer diagnosis was documented in >99.8% of notes regardless of template use. Template use was associated with increased documentation of 7 QMs (Table). Documentation overall completeness improved from 62% to 90% with a very large effect size (Table). Template use positively correlated with female gender and fewer years since last training (p<0.001). In the subgroup of notes written by “users” (21 physicians, 4 APPs), individual QM and overall completeness scores improved with template use (p<0.001). Conclusions: Template use profoundly improved QM documentation (statistically significant and clinically meaningful) by Onc clinic providers. This strategy enhances mCODE compatible structured data collection and semantic interoperability between systems, strengthening the available real-world data (RWD) in EHR. [Table: see text]