Changes in Psychological Burden and Quality of Life During In Vivo Diagnostic Evaluation for Immediate Drug Hypersensitivity: A Prospective Stepwise Study

Abstract

Background/Objective: The psychological impact of in vivo diagnostic procedures remains poorly understood. We assessed changes in psychological distress and drug hypersensitivity-related quality of life (QoL) throughout a diagnostic evaluation for suspected immediate drug hypersensitivity reactions (IDHRs) and aimed to identify predictors of persistent psychological burden. Methods: This single-center prospective observational longitudinal study included 100 consecutive adults undergoing evaluation for suspected IDHRs. Psychological distress and QoL were assessed using the Depression Anxiety Stress Scale-21 (DASS-21) and the Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q). Assessments were performed before and after each diagnostic phase, including skin tests (STs), placebo, and drug provocation tests (DPTs). Results: The mean age was 44.2 ± 12.5 years, and women comprised 72% of the cohort. Depression, anxiety, stress, and DrHy-Q scores significantly decreased after ST, placebo, and DPT compared with baseline measurements. Across diagnostic stages, depression, anxiety, stress, and DrHy-Q scores were significantly lower during the DPT phase than during the ST and placebo phase in both pre-test and post-test measurements (p < 0.01 for pairwise comparisons). The number of prior HSRs showed a weak but significant positive correlation with DrHy-Q scores. In multivariable linear regression analysis, the number of prior HSRs was the only independent predictor of post-DPT DrHy-Q scores (β = 3.43, 95% CI 1.36–5.50, p = 0.001). Patients who avoided the provoked drug despite a negative DPT had higher DPT-post depression, anxiety, stress, and DrHy-Q scores. Conclusions: Psychological burden progressively decreased over the course of the stepwise diagnostic evaluation for suspected IDHRs, although patients with repeated reactions may benefit from additional support.

The authors' abstract, as published at the source. Journal of Clinical Medicine, 2026 · DOI ↗