7-day Urticaria Control Test scores correlate with results from 4-week version

Key takeaways:

• The shorter window is designed to mitigate recall bias among patients.
• The UCT7’s internal consistency reliability had a Cronbach alpha value of 0.91.
• A UCT7 score of 12 points identifies well-controlled disease.

The UCT7 reduces the Urticaria Control Test’s 4-week recall period to 7 days to assess disease control at short intervals in clinical studies and practice, according to a study published in The Journal of Allergy and Clinical Immunology.

Researchers validated the UCT7 against results from a variety of other patient-reported outcome measures and tools, Thomas Buttgereit, MD, of the Institute for Allergology, Charité University of Medicine in Berlin, and colleagues wrote.

The researchers noted that the 4-week recall period in the Urticaria Control Test (UCT) is subject to recall bias, prompting the development of the UCT7 and its shorter recall period. Still, the UCT7 uses the same four questions as the UCT, with an adjustment for time:

• “How much have you suffered from the physical symptoms of the urticaria (itch, hives [welts] and/or swelling) in the last 7 days?
• How much was your quality of life affected by the urticaria in the last 7 days?
• How often was the treatment for your urticaria in the last 7 days not enough to control your urticaria symptoms?
• Overall, how well have you had your urticaria under control in the last 7 days?”

Patients select one of five responses for each question, ranging from not at all to very much, very often or very well, depending on the question. Each response is worth 0 to 4 points. The maximum score, 16 points, indicates complete disease control.

The researchers validated the UCT7 with 152 patients (mean age, 42.1 ± 16.7 years; 64.5% female) with physician-diagnosed chronic urticaria, including 10 patients who were aged 12 to 17 years.

Diagnoses included 101 patients with chronic spontaneous urticaria (CSU) and 51 with chronic inducible urticaria (CIndU). Fifteen 15 patients had comorbid CSU and CIndU, with 10 reporting symptomatic dermographism. Also, the patients with CIndU included 18 with cold urticaria and 17 with symptomatic dermographism.

Overall, 40 patients had recurrent wheals but no angioedema, 44 had both wheals and angioedema and 17 exclusively had recurrent angioedema.

Patients completed surveys at baseline and at day 28. They also completed the UCT and UCT7 at baseline and at days 7, 14, 21 and 28 in addition to other measurements and assessments.

The UCT7 had a Cronbach alpha value of 0.91, which the researchers said indicated excellent internal consistency reliability. Subanalyses found Cronbach alpha values of 0.93 for patients with predominant CSU, 0.91 for patients with CSU and CIndU, and 0.88 for patients with CIndU.

The researchers also called the internal consistency reliability excellent based on Cronbach alpha values of 0.89 for patients with CSU and wheals without angioedema, 0.97 for patients with wheals and angioedema, and 0.92 for patients with angioedema exclusively.

Further, the researchers said the UCT7 had strong and highly significant correlations with 7-day Urticaria Activity Scores (UAS7), urticaria-specific quality-of-life impairment (CU-Q2oL) and anchors for disease activity and control among the total patient population and in subgroups based on diagnosis.

Subanalyses based on patients with wheals only, wheals and angioedema, and angioedema only had high levels of convergent validity as well, the researchers continued.

Correlations were particularly strong between the UCT7 and the Angioedema Activity Score 7-day summary (AAS7) for angioedema activity and the Angioedema Quality of Life Questionnaire (AE-QoL) for angioedema impact, the researchers said.

The UCT7 yielded different results in patients who had different disease activity and levels of urticaria control compared with patient global assessments of activity and control that used a Likert scale, different UAS7 categories and different treatment responses, the researchers said.

Specifically, the researchers said, patients with higher disease activity based on UAS7 and patient global assessments of activity using a Likert scale and insufficient response to treatment had lower UCT7 scores, indicating lower disease control.

The researchers additionally said that the UCT7 demonstrated its high accuracy in identifying patients with poorly controlled urticaria compared with those with well controlled urticaria via its 0.86 (95% CI, 0.792-0.919) area under the receiver operating characteristic curve.

When cutoff values for separating patients with poorly controlled and well controlled urticaria were considered, UCT7 scores of 10 and higher had 85% sensitivity and 73% specificity. Scores of 11 and higher had 82% sensitivity and 77% specificity. Scores of 12 and higher had 72% sensitivity and 83% specificity.

A cutoff value of 13 and higher had greater than 90% specificity, the researchers continued, with cutoff values of 11 and 12 points both resulting in the highest proportion of correctly classified patients at greater than 78%.

The researchers also noted that of patients with UCT7 scores of 10 or lower, 85% said their treatment was “not sufficient,” and of patients with UCT7 scores of 11 or lower, 80% said the same.

Between baseline and day 28, 79 patients did not report any changes in their patient global assessment of control Likert scale (PatGA-Control-LS) scores, whereas their mean UCT7 scores fell from 10.9 ± 4.4 to 10.8 ± 4.4, which the researchers did not consider a change. The 0.9 (95% CI, 0.84-0.93) interclass correlation coefficient indicated excellent test-retest reliability, the researchers said.

Strong correlations between changes in UCT7 scores and in UAS7, CU-Q2oL, patient global assessment of control using visual analog scale, and physician global assessment of control using the visual analog scale at baseline and day 28, in addition to other patient-reported and physician-reported measures, indicated that the UCT7 was sensitive enough to detect changes in disease control as well, the researchers said.

However, the researchers noted, correlations were weak or did not exist for changes in UCT7 scores and changes in the results of patient-reported outcome measurements such as the AAS7 and AE-QoL.

Yet the correlation between changes in UCT7 and PatGA-Control-LS scores was strong at –0.8 (P < .001), the researchers continued. Patients with improvements in disease control had a mean change in UCT7 score of 2.3 ± 3.6 (median, 1 point; interquartile range [IQR], 6 points) with PatGA-Control-LS as an anchor.

Also compared with PatGA-Control-LS scores, mean changes in UCT7 included –0.1 ± 2.7 (median, 0 points; IQR, 3 points) for patients with stable disease and –2.1 ± 2.0 (median, –1 point; IQR, 4 points) for patients with reduced control.

Based on these findings, the researchers said that all patients with chronic urticaria can use the UCT7 before every physician visit, although those with angioedema but no wheels should use the Angioedema Control Test.

The researchers also noted that 12 points would be the cutoff value for well-controlled disease with the UCT7, as it is with the UCT, with an increase of 2 points reflecting clinically meaningful improvement for easy implementation in clinical trials and routine care.