New Questionnaire Measures Patients’ View of Disease Control in Recurrent Angioedema

Researchers developed a questionnaire, called the Angioedema Control Test (AECT), that may be helpful in monitoring disease control and patient-reported outcomes among people with recurrent angioedema.

The tool is described in the journal Allergy, in the study, “Development of the Angioedema Control Test (AECT) – A Patient Reported Outcome Measure That Assesses Disease Control in Patients With Recurrent Angioedema.” The study was funded by Shire.

Recurrent angioedema refers to any condition involving multiple bouts of swelling, regardless of their root cause: it may be a consequence of chronic urticaria or the absence of C1-INH, as happens in hereditary and acquired angioedema.

Given its significant impact on quality of life — it “often results in patients being controlled by their disease,” according to the researchers — it is necessary to track disease status in people with recurrent angioedema, whether as part of a clinical trial or patient monitoring as part of routine care.

However, disease status tracking in recurrent angioedema is difficult, since swelling attacks occur with unpredictable frequency and severity. Currently, two tools are used to assess disease status in recurrent angioedema: the Angioedema Activity Score (AAS) and the Angioedema Quality of Life Questionnaire (AE-QoL).

Although these two assessments are both useful, that study noted that each has its flaws: the AAS requires patients to essentially keep a diary, so it only works if patients are able to continually make entries. The AE-QoL requires expertise to interpret, such that the results typically cannot be given until some time after the assessment itself is taken — a delay that may also delay important treatment decisions.

To address these shortcomings, researchers set out to create a new tool aimed particularly at measuring disease control for people with recurrent angioedema. Both measure how in control of their disease patients feel, and the extent to which they may feel the disease is controlling them.

Generating this questionnaire involved collaborations between experts and patients. Broadly, panels created questionnaires with many questions, and these were reviewed by 97 people with recurrent angioedema (mean age, 49.5). The researchers then used their responses to remove unnecessary questions: the goal was to create a tool that would provide as much possible relevant data with as few possible questions.

Ultimately, the questionnaire consisted of four questions asking about the frequency and severity of angioedema experienced in the last three months.  Each question has five response choices.

For example, the question “In the last three months, how well has your angioedema been controlled by your therapy?” has response options ranging from “not at all” to “very well.”

The researchers emphasized that the simplicity of the AECT could allow it to be easily integrated into routine use.  The AECT’s “retrospective approach, its brevity and its simple scoring,” they wrote, “ensure a low administrator and patient burden and allow for its application in daily patient care and clinical trials.”

However, they noted, more research is needed before the data generated by the AECT will be meaningful: “Validation studies are needed to further characterize the AECTs validity, the AECTs reliability and to define relevant cut off-values.”