Building Consensus for a Shared Definition of Adverse Events: A Case Study in the Profession of Dentistry

BACKGROUND: To achieve high-quality health care, adverse events (AEs) must be proactively recognized and mitigated. However, there is often ambiguity in applying guidelines and definitions. We describe the iterative calibration process needed to achieve a shared definition of AEs in dentistry. Our alignment process includes both independent and consensus building approaches. OBJECTIVE: We explore the process of defining dental AEs and the steps necessary to achieve alignment across different care providers. METHODS: Teams from 4 dental institutions across the United States iteratively reviewed patient records after identification of charts using an automated trigger tool. Calibration across teams was supported through negotiated definition of AEs and standardization of evidence provided in review. Interrater reliability was assessed using descriptive and κ statistics. RESULTS: After 5 iterative cycles of calibration, the teams (n = 8 raters) identified 118 cases. The average percent agreement for AE determination was 82.2%. Furthermore, the average, pairwise prevalence and bias-adjusted κ (PABAK) was 57.5% (κ = 0.575) for determining AE presence. The average percent agreement for categorization of the AE type was 78.5%, whereas the PABAK was 48.8%. Lastly, the average percent agreement for categorization of AE severity was 82.2% and the corresponding PABAK was 71.7%. CONCLUSIONS: Successful calibration across reviewers is possible after consensus building procedures. Higher levels of agreement were found when categorizing severity (of identified events) rather than the events themselves. Our results demonstrate the need for collaborative procedures as well as training for the identification and severity rating of AEs

Hybrid immunity and SARS-CoV-2 antibodies: results of the HEROES-RECOVER prospective cohort study

There are limited data on whether hybrid immunity differs by count and order of immunity-conferring events (SARS-CoV-2 infection or COVID-19 vaccination). From a cohort of health care personnel, first responders, and other frontline workers in six US states, we examined heterogeneity of the effect of hybrid immunity on SARS-CoV-2 antibody levels. Exposures included event-count (sum of infections and vaccine doses) and event-order, categorized into seven permutations of vaccination and/or infection. Outcome was level of serum binding antibodies against receptor binding domain (RBD) of the ancestral SARS-CoV-2 spike protein (total RBD-binding Ig), measured by enzyme-linked immunosorbent assay. Mean antibody levels were examined up to 365 days after each of the 1st-7th events. Analysis included 5,793 participants measured from August 7, 2020 to April 15, 2023. Hybrid immunity from infection before one or two vaccine doses elicited modestly superior antibody responses after the 2nd and 3rd events (compared to infections or vaccine-doses alone). This superiority was not evident after the 4th and 5th events (additional doses). Among adults infected before vaccination, adjusted geometric mean ratios (95% CI) of anti-RBD early response (versus vaccinated-only) were 1.23 (1.14-1.33), 1.09 (1.03-1.14), 0.87 (0.81-0.94), and 0.99 (0.85-1.15) after the 2nd-5th events, respectively. Post-vaccination infections elicited superior responses: adjusted geometric mean ratios (95% CI) of anti-RBD early response (versus vaccinated-only) were: 0.93 (0.75-1.17), 1.11 (1.06-1.16), 1.17 (1.11-1.24), and 1.20 (1.07-1.34) after the 2nd-5th events, respectively. Findings reflecting heterogeneity in antibody levels by permutations of infection and vaccination history could inform COVID-19 vaccination policy