Sensitivity to change and minimal clinically important difference of the angioedema control test

Abstract

BackgroundThe Angioedema Control Test (AECT) is a patient‐reported outcome measure developed and validated for the assessment of disease control in patients with recurrent angioedema. Its sensitivity to change and minimal clinically important difference (MCID) have hitherto not been established.MethodsPatients with recurrent angioedema due to chronic spontaneous urticaria, hereditary angioedema, or acquired C1‐inhibitor deficiency were repeatedly asked to complete the AECT along with the Angioedema Quality of Life Questionnaire (AE‐QoL), Dermatology Life Quality Index (DLQI), and anchors for disease control and whether treatment was sufficient during routine care visits. The sensitivity to the change of the AECT was determined by correlating changes in its scores over time with changes in the applied anchors. The MCID was determined using anchor‐based and distributional criterion‐based approaches.ResultsEighty‐six cases were used for this analysis. Changes in AECT scores correlated well with AE‐QoL changes (but less with changes in the DLQI) as well as other applied anchors, demonstrating its sensitivity to change. The MCID was found to be three points for improvement of angioedema control. The available number of cases with meaningful deterioration in our dataset was too low to reach a definite conclusion on the MCID for deterioration of angioedema control.ConclusionThe AECT is a valuable tool to assess changes in disease control in patients with recurrent angioedema over time. The lowest AECT score change that reflects a meaningful improvement of disease control to patients (MCID) is three points.

Monitoring recurrent angioedema: Findings from the Turkish angioedema control test validation study

“…reported that the strength of sensitivity to change of AECT‐4wk to detect the change in disease control determined by physicians, angioedema related QoL and patient rated treatment sufficiency was high while it was lower in the detection of change in patients‐self assessment of disease control. However, they did not analyze the correlation between change in AECT‐4wk and change in disease activity and sensitivity to change in AECT‐3mth 11 . We found that changes in AECT‐4wk were sensitive to detect the changes in disease activity, disease control assessed by patients and treatment sufficiency, while less sensitive to detect the changes in AE‐related QoL.…”

“…Fijen et al. reported that 3‐point change in AECT‐4wk can detect the minimal clinically important improvement in the disease control level of patients with RAE with a sensitivity of 86% and a specificity of 91% 11 . We found that at least 2‐point increase in AECT over 4 weeks could detect a meaningful improvement in disease control with 78.1% sensitivity and 77.6% specificity and at least 3‐3‐point increase with lower sensitivity (68.8%) but better specificity (83.7%).…”

“…10 Recently, the minimal clinically important difference (MCID) of AECT-4wk was determined to be three points; however, it has not been assessed for the AECT-3mth yet. 11 The AECT is easy to perform and score, valid, and reliable, and it has become the gold standard for assessing disease control and guiding treatment decisions in RAE. It is widely available, in 47 languages including Turkish, but the Turkish AECT versions remain to be assessed for their validity, reliability, screening accuracy, sensitivity to change, and MCID.…”

“…A total score <10 points and equal or ≥10 points indicates poorly‐controlled and well‐controlled disease, respectively, with 76% sensitivity and 84% specificity 10 . Recently, the minimal clinically important difference (MCID) of AECT‐4wk was determined to be three points; however, it has not been assessed for the AECT‐3mth yet 11 …”

“… 10 Recently, the minimal clinically important difference (MCID) of AECT‐4wk was determined to be three points; however, it has not been assessed for the AECT‐3mth yet. 11 …”