Stratified Assessment and Warning Regimen for Comprehensive Risk Management and Improved Iodinated Contrast Media Safety

Abstract

Objectives: To determine the relationship between stratified assessment and warning (SAW) regimen for risk factors to iodinated contrast media (ICM) and adverse drug reactions (ADR) occurrence.Methods: This retrospective study included patients who underwent enhanced CT examinations in our hospital between January 2014 and March 2016 (conventional assessment group) and between April 2017 and December 2019 (SAW group). Initial risk assessment was performed by clinicians when ordering examinations in both periods. The risk re-assessment was performed by simple question-and-answer onsite just before examination in the conventional assessment period, according to the risk factors that deserve special attention in ICM guidelines. In the SAW period, the re-assessment process prior to examination was moved forward as early as possible post-appointment, and a whole-process comprehensive management integrating risk identification, stratification, early warning and prevention was performed according different risk levels. Chi-square test was performed for comparisons of rates.Results: A total of 120822 cases in the conventional assessment group and 150343 cases in the SAW group were enrolled. The total ADR incidence in the SAW period (414/150343, 0.275%) was lower than that in the conventional assessment period (506/120822, 0.419%, P<0.001), in which the proportion of patients who developed ADR decreased by about 34%. It mainly presented as decrease in mild/moderate reactions (P<0.001) and increase in the proportion of mild ADR patients (P=0.001) in the SAW period. Subgroup analysis showed lower mild/moderate ADR incidence in patients with different risk levels and with different ICM injection parameters (P<0.05) following SAW regimen.Conclusions: SAW regimen was associated with lower mild/moderate ADR incidence and alleviated ADR severity in at-risk patients, which held potential for improved risk management and ICM safety.