Development of the Angioedema Control Test—A patient‐reported outcome measure that assesses disease control in patients with recurrent angioedema

Abstract

Background: Recurrent angioedema (AE) is an important clinical problem in the context of chronic urticaria (mast cell mediator-induced), ACE-inhibitor intake and hereditary angioedema (both bradykinin-mediated). To help patients obtain control of their recurrent AE is a major treatment goal. However, a tool to assess control of recurrent AE is not yet available. This prompted us to develop such a tool, the Angioedema Control Test (AECT).Methods: After a conceptional framework was developed for the AECT, a list of potential AECT items was generated by a combined approach of patient interviews, literature review and expert input. Subsequent item reduction was based on impact analysis, inter-item correlation, additional predefined criteria for item performance, and a review of the item selection process for content validity. Finally, an instruction section was generated, and an US-American-English version was developed by a structured translation process. Results:A 4-item AECT with recall periods of 4 weeks and 3 months was developed based on 106 potential items tested in 97 patients with mast cell mediator-induced (n = 49) or bradykinin-mediated recurrent AE (n = 48). Eighty-four items were excluded based on impact analysis. The remaining 22 items could be further reduced by a method-mix of inter-item correlation, additional predefined criteria for item performance and review for content validity. Conclusions:The AECT is the first tool to assess disease control in recurrent AE patients. Its retrospective approach, its brevity and its simple scoring make the AECT ideally suited for clinical practice and trials. Its validity and reliability need to be determined in future independent studies. K E Y W O R D SAECT, angioedema, development, disease control, impact analysis, item selection

The global burden of chronic urticaria for the patient and society*

“…In addition to HRQoL, disease control can be captured in patients with CSU and CIndU with the Urticaria Control Test 96 and the Angioedema Control Test, 97,98 which measure the level of control over signs and symptoms, as well as the impact achieved by the current treatment strategy. Accordingly, the concepts of HRQoL and disease control are linked, where a low level of disease control goes along with high HRQoL impairment and vice versa 96–100 …”

“…Accordingly, the concepts of HRQoL and disease control are linked, where a low level of disease control goes along with high HRQoL impairment and vice versa. [96][97][98][99][100] Impact on sleep, family life and partners, sexual functioning and joie de vivre Pruritus and the severity of hives, as well as the fear of angiooedema attacks, are mainly responsible for sleep difficulties, such as difficulty staying asleep or waking up too early, with resulting fatigue and diminished physical and emotional wellbeing during the day. 73 CSU also affects the families and partners of patients and significantly impairs sexual functioning.…”

Urticaria: Collegium Internationale Allergologicum (CIA) Update 2020

“…The AECT is a novel tool that quantifies disease control in CSU patients with angioedema as well as in patients with other forms of recurrent angioedema [77,78]. The AECT is a retrospective PROM.…”

Differences and Similarities in the Mechanisms and Clinical Expression of Bradykinin-Mediated vs. Mast Cell–Mediated Angioedema

“…Studies are available on MCM-AE and BK-AE and its association with other comorbidities, burden of disease, impact on sleep, and social, mental, and sexual health. More studies are required to compare these entities, controlling patients for age, gender, genetic background, and other important confounders, by using tools that are suitable for all AE patients such as the angioedema activity score (AAS) or the angioedema control test (AECT) [83,84]). Ideally, such studies should be performed in a global setting and by professional networks, such as that of angioedema centers of reference and excellence (ACARE, [85]).…”