Figure. The number of patients improving or otherwise their Urticaria Activity Score (UAS7), Dermatology Life Quality Index (DLQI), total Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), and CU-Q2oL domain scores following adjustment of therapy. The total number of patients in each column is 51.
Weller K, Church MK, Kalogeromitros D, Krause K, Magerl M, Metz M, Pisarevskaja D, Siebenhaar F, Maurer M. Chronic Spontaneous Urticaria: How to Assess Quality of Life in Patients Receiving Treatment. Arch Dermatol. 2011;147(10):1221-1223. doi:10.1001/archdermatol.2011.310
Author Affiliations: Department of Dermatology and Allergy, Charit é-Universit ätsmedizin Berlin, Germany (Drs Weller, Church, Kalogeromitros, Krause, Magerl, Metz, Siebenhaar, and Maurer, and Ms Pisarevskaja); and Department of Dermatology, Odense Universitets Hospital, Odense, Denmark (Dr Maurer).
Because of the long duration and fluctuating severity of symptoms of chronic spontaneous urticaria (CSU), strict criteria are necessary to assess disease activity, disease-specific impairment of quality of life (QoL), and the influence of treatment on these.1 Two types of assessment have been developed: clinical scoring systems and QoL questionnaires. Perhaps the most effective clinical scoring system is the Urticaria Activity Score (UAS7), which is based on the daily assessment of the key urticaria symptoms, wheals, and pruritus over 7 days.2 The documentation of symptoms for several days in a row is critical to ensure UAS results that are truly representative for the patients' disease activity because urticaria symptoms can vary considerably from day to day. This study extended the validation of the German version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)3,4 by comparing it with the UAS7 and the Dermatology Life Quality Index (DLQI)5 in assessing the clinical response to change in therapy in CSU.
The study took place at the specialist urticaria clinic at the Department of Dermatology and Allergy, Charit é –Universit ätsmedizin, Berlin, Germany, where 51 patients (12 male and 39 female; age range, 20-80 years) diagnosed as having CSU and having a minimum UAS7 score of 7 out of a possible 42 during the previous week were admitted to the study. The day before the clinic visit, patients completed DLQI and CU-Q2oL questionnaires to assess the effect of their CSU on their QoL. Following a thorough clinical examination, their therapy was adjusted in an attempt to improve symptom control and QoL. All patients were given a second self-assessment package (UAS7, DLQI, CU-Q2oL) for completion before their reassessment visit 4 weeks to 3 months later. While the German version of the CU-Q2oL has been validated previously,4 we are not aware of a validation study for the German version of the DLQI. However, this instrument has been shown its high value in multiple German and international health-related QoL studies, and it has been validated as an outcome measure for urticaria-related QoL. Results are presented as mean (SEM) scores, and groups are compared using the Wilcoxon test. Correlations were calculated using Pearson correlation.
The mean (SEM) scores for the UAS7, DLQI, total CU-Q2oL, and CU-Q2oL domains before and after adjustment of therapy are shown in the Table. The number of patients showing symptomatic improvement, defined as a reduction in their score for individual tests, is shown in the Figure.
The primary comparisons in this study were between the UAS7 and the 2 QoL assessments. The initial mean (SEM) UAS7 score was only 18.7 (2.1) out of a maximum of 42, indicating that the patients' initial treatment was already reasonably effective. Adjustment of therapy was associated with an improvement of 21% in the UAS7 score (P = .02) with 67% of patients showing symptomatic improvement. In contrast, the 14% reduction in the DLQI was not statistically significant (P = .23). Furthermore, following treatment adjustment, only 47% reported improvement with even fewer, 29%, showing an improvement in DLQI score of 2.24 or more points, the suggested minimal important difference required to indicate a clinically significant improvement. Although the improvement in the CU-Q2oL total score of 15% with treatment adjustment was similar to that of the DLQI, the response was less variable and was significant (P = .001). Furthermore, 69% of patients reported improvement in their score. Of the CU-Q2oL domains, “itching/embarrassment, ” “sleep, ” and “mental status ” achieved the highest initial scores and the most significant improvement following therapy adjustment (P ≤ .001). There was no significant improvement in the “functioning ” or “limits and looks ” domains.
The total score of the CU-Q2oL correlated more strongly (r = 0.39; P = .005) with the UAS7 than did the DLQI (r = 0.33; P = .02). Of the individual CU-Q2oL domains, significant correlations with UAS7 were found for functioning (r = 0.31; P = .03), itching/embarrassment (r = 0.54; P < .001), and mental status (r = 0.28; P = .048) domains while those of sleep, swelling/eating, and limits and looks were not.
The CU-Q2oL is the first and currently only instrument to assess disease-specific QoL in patients with CSU. The CU-Q2oL scores detected in this examination are comparable with those of a previous German study4 and further support its usefulness. The relatively small improvement of QoL following treatment adjustment mirrors the fact that the disease in the observed patients was already under reasonable control by their previous therapy. It might be considered as a limitation that a spontaneous rather than a treatment-dependent improvement of the disease cannot be fully excluded in this study. However, this does not affect the results on the instruments sensitivity to change.
In conclusion, this study demonstrates that the German version of the CU-Q2oL is a valid instrument to detect changes in QoL associated with changes in disease activity following changes in therapy and that it is more sensitive in comparison with other, non –disease-specific QoL measures such as the DLQI. Because patient QoL is of paramount importance, we recommend that both the UAS7 and CU-Q2oL should be used routinely for assessing patient responses to therapy.
Correspondence: Dr Maurer, Allergie-Centrum-Charit é, Department of Dermatology and Allergy, Charit é –Universit ätsmedizin Berlin, Charit éplatz 1, D-10117 Berlin, Germany (firstname.lastname@example.org).
Accepted for Publication: June 20, 2011.
Author Contributions: All authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Weller, Church, Kalogeromitros, Metz, Siebenhaar, and Maurer. Acquisition of data: Weller, Krause, Metz, Pisarevskaja, and Siebenhaar. Analysis and interpretation of data: Weller, Church, Kalogeromitros, Magerl, and Maurer. Drafting of the manuscript: Weller, Church, Kalogeromitros, and Maurer. Critical revision of the manuscript for important intellectual content: Weller, Church, Krause, Magerl, Metz, Pisarevskaja, Siebenhaar, and Maurer. Statistical analysis: Church and Pisarevskaja. Obtained funding: Siebenhaar and Maurer. Administrative, technical, and material support: Magerl and Siebenhaar. Study supervision: Weller and Maurer.
Financial Disclosure: None reported.
Funding/Support: This study was funded in part by the European Allergy Research Foundation (ECARF; www.ecarf.org) and supported by GA2LEN, the Global Allergy and Asthma European Network (www.ga2len.net).
Additional Contributions: Nikki Rooks, Hesna Goezl ükaya, and the nurses of the Allergie-Centrum-Charit é provided excellent administrative support.