Development and validation of the Urticaria Control Test: A patient-reported outcome instrument for assessing urticaria control Karsten Weller, MD,a Adriane Groffik, MD,b Martin K. Church, PhD, DSc,a Tomasz Hawro, MD,a Karoline Krause, MD,a Martin Metz, MD,a Peter Martus, PhD,c Thomas B. Casale, MD,d Petra Staubach, MD,b and Marcus Maurer, MDa Berlin, Mainz, and T€ ubingen, Germany, and Omaha, Neb Background: Chronic urticaria is a frequent and debilitating skin disease. Its symptoms commonly fluctuate considerably from day to day. As of yet, the only reliable tool to assess disease activity is the Urticaria Activity Score, which prospectively documents the signs and symptoms of urticaria for several days. Objective: We sought to develop and validate a novel patientreported outcome instrument to retrospectively assess urticaria control, the Urticaria Control Test (UCT). Methods: Potential UCT items were developed by using established methods (literature research and expert and patient involvement). Subsequently, item reduction was performed by using a combined approach, applying impact and regression analysis. The resulting UCT instrument was then tested for its validity, reliability, and screening accuracy. Results: A 4-item UCT with a recall period of 4 weeks was developed based on 25 potential UCT items tested in 508 patients with chronic urticaria. A subsequent validation study with the 4-item UCT in 120 patients with chronic urticaria demonstrated that this new tool exhibits good convergent and known-groups validity, as well as excellent test-retest reliability. In addition, the screening accuracy to identify patients with urticaria with insufficiently controlled disease was found to be high. Conclusions: The UCT is the first valid and reliable tool to assess disease control in patients with chronic urticaria (spontaneous and inducible). Its retrospective approach and simple scoring system make it an ideal instrument for the management of patients with chronic urticaria in clinical practice. (J Allergy Clin Immunol 2014;nnn:nnn-nnn.) Key words: Disease control, disease activity, urticaria, development, validation
From athe Department of Dermatology and Allergy, Allergie-Centrum-Charite, Charite–Universit€atsmedizin Berlin; bthe Department of Dermatology, University Medical Center Mainz; cthe Institute for Clinical Epidemiology and Applied Biometry, Eberhard-Karls-University T€ubingen; and dthe Division of Allergy and Immunology, Creighton University, Omaha. Supported in part by the Urtikaria Network e.V. (UNEV) and Novartis Germany. Disclosure of potential conflict of interest: M. Maurer has received consultancy fees from Almirall, Bayer, Biofrontera, FAES, Genentech, GlaxoSmithKline, Recordati, Novartis, Sanofi Aventis, MSD, Moxie, UCB, and Uriach; is employed by Charite– Universit€atsmedizin Berlin; and has received research support from FAES, Genentech, Novartis, MSD, Moxie, UCB, and Uriach. The rest of the authors declare that they have no relevant conflicts of interest. Received for publication September 11, 2013; revised December 2, 2013; accepted for publication December 18, 2013. Corresponding author: Marcus Maurer, MD, Allergie-Centrum-Charite, Department of Dermatology and Allergy, Charite–Universit€atsmedizin Berlin, Chariteplatz 1, D-10117 Berlin, Germany. E-mail: [email protected]. 0091-6749/$36.00 Ó 2014 American Academy of Allergy, Asthma & Immunology http://dx.doi.org/10.1016/j.jaci.2013.12.1076
Abbreviations used AE: American English CIndU: Chronic inducible urticaria CSU: Chronic spontaneous urticaria CU-Q2oL: Chronic Urticaria Quality of Life Questionnaire ICC: Intraclass correlation coefficient LS: Likert scale PatGA: Patient’s global assessment PhyGA: Physician’s global assessment PRO: Patient-reported outcome ROC: Receiver operating characteristic UAS: Urticaria Activity Score UAS28: Urticaria Activity Score assessed for 28 days UCT: Urticaria Control Test VAS: Visual analog scale
Urticaria is a frequent skin disorder characterized by recurrent, transient, pruritic wheal and flare–type skin reactions, angioedema, or both.1 Every fifth person experiences at least 1 episode of any type of urticaria during his or her life.1 A recent study confirmed that office-based dermatologists, general practitioners, and pediatricians treat between 12 and 25 patients with urticaria every month.2 In addition, many patients (31%)2 are referred to and are treated by tertiary care centers.3 Accordingly, urticaria is of high relevance in real-life medical care. Assessing disease activity of patients with urticaria is a major problem because urticaria symptoms commonly fluctuate considerably from day to day. Therefore the clinical picture of a patient at the time of presentation to his or her treating physician is only rarely representative of the actual current disease status. As of yet, the only reliable way to assess current disease activity is the prospective determination of symptoms over several consecutive days with the Urticaria Activity Score (UAS).4 The UAS works as a daily diary quantifying wheals and itching. Although it proved to be a useful tool and became the gold standard for measuring disease activity in patients with chronic spontaneous urticaria (CSU),5 it has some major limitations. First, it works only as a prospective instrument and therefore cannot be used during a first patient contact. Second, its evaluation becomes problematic if patients forget its completion on single days. Third, it does not cover angioedema, which commonly occurs in patients with CSU or even as the only disease symptom of CSU. Fourth, it is designed only for patients with CSU and not other subtypes of chronic urticaria, such as chronic inducible urticaria (CIndU; eg, symptomatic dermographism, cholinergic urticaria, delayed pressure urticaria, and cold contact urticaria), although many patients have a combination of CSU and 1
2 WELLER ET AL
CIndU or CIndU alone. Finally, it has not been primarily developed to assess disease control. These limitations prompted us to develop a new, brief, and simple tool for quantifying disease control in all patients with all types of chronic urticaria and to aid treatment decisions. Additional properties of this new instrument should be that (1) it is a patient-based (patient-reported outcome [PRO]) instrument, (2) it is a retrospective tool that is independent of any previous patient presentations, (3) it is easy to administer and fast to complete, and (4) it is easy to score and interpret for the treating physicians. Here we report the development of such a tool, the Urticaria Control Test (UCT; Fig 1).
J ALLERGY CLIN IMMUNOL nnn 2014
A
Urtikariakontrolltest
Name: __________________________
Anleitung: Sie leiden unter einer Nesselsucht (Urtikaria). Mit den folgenden Fragen soll ihre aktuelle Krankheitssituation erfasst werden. Bitte lesen Sie sich jede Frage sorgfältig durch und wählen Sie aus den fünf Antworten diejenige aus, die für Sie am besten zutrifft. Bitte beziehen Sie sich dabei auf die vergangenen 4 Wochen. Überlegen Sie bitte nicht lange und denken Sie daran, alle Fragen zu beantworten und für jede Frage nur eine Antwort auszuwählen. 1. Wie sehr haben Sie in den vergangenen 4 Wochen unter den körperlichen Beschwerden der Urtikaria (Juckreiz, Quaddelbildung und/oder Schwellungen) gelitten? O sehr stark
The development of the UCT consisted of 3 main phases: (1) item generation, (2) item reduction, and (3) UCT validation. The development process of the well-established Asthma Control Test6 served as a model for our approach.
Item generation UCT item generation was performed by following current recommendations for PRO development.7 An expert working group was convened and helped to specify fields of urticaria control that should be assessed by the UCT, to guide the generation of specific survey questions, to define criterion measures of urticaria control (anchors) to be used for the evaluation of the survey’s performance, and to design and conduct the item-selection and validation studies. In addition, the literature was searched for existing PRO instruments in chronic urticaria and published information on how to best measure disease control. This was complemented by exploratory semistructured interviews with 10 patients with CSU and 5 patients with CIndU.
O stark
O mittelmäßig
O wenig
O gar nicht
2. Wie sehr war Ihre Lebensqualität in den vergangenen 4 Wochen wegen der Urtikaria beeinträchtigt? O sehr stark
METHODS
Datum: ____ . ____ . ________
Geburtsdatum: ____ . ____ . ________
O stark
O mittelmäßig
O wenig
O gar nicht
3. Wie oft hat die Therapie für Ihre Urtikaria in den vergangenen 4 Wochen nicht ausgereicht, um die Urtikariabeschwerden zu kontrollieren? O sehr oft
O oft
O gelegentlich
O selten
O gar nicht
4. Wie gut hatten Sie Ihre Urtikaria in den vergangenen 4 Wochen insgesamt unter Kontrolle? O gar nicht
O kaum
B
O mittelmäßig
O gut
O vollständig
Urticaria Control Test
Patient name: ___________________________
Date: (dd mmm yyyy): ___ ____ _____
Date of birth (dd mmm yyyy): ___ ____ _____
Instructions: You have urticaria. The following questions should help us understand your current health situation. Please read through each question carefully and choose an answer from the five options that best fits your situation. Please limit yourself to the last four weeks. Please don’t think about the questions for a long time, and do remember to answer all questions and to provide only one answer to each question. 1. How much have you suffered from the physical symptoms of the urticaria (itch, hives (welts) and/or swelling) in the last four weeks? O very much
O much
O somewhat
O a little
O not at all
2. How much was your quality of life affected by the urticaria in the last 4 weeks? O very much
Data collection during UCT item-selection and UCT validation phase Patients with chronic urticaria at 2 urticaria specialist centers (Berlin and Mainz, Germany) were recruited into the UCT item-selection (ClinicalTrials. gov identifier: NCT01610128) and UCT validation (ClinicalTrials.gov identifier: NCT01614834) phases. Participation in the item-selection phase was also possible online (recruitment through the Web page of the Urticaria Network e.V.: www.urtikaria.net). Each site’s local ethics committee approved the study, and all participants had to provide informed consent. The physician-based diagnosis of CSU, CIndU, or both was a prerequisite for inclusion. In the item-selection phase patients had to complete an evaluation form of all potential UCT items. On this form, they scored the frequency and importance, as well as the understandability, comprehensibility, and completeness, of the items. In addition, they provided information on their current level of disease control. In the UCT validation phase patients completed a survey twice (on days 0 and 28). The survey consisted of all final UCT items (items selected in the UCT item-selection phase, see below), global assessments of disease severity, disease control, and treatment sufficiency during the previous 4 weeks measured by using a visual analog scale (VAS) or a Likert scale (LS), the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), and questions on disease duration and sociodemographic characteristics. In addition, the patients were asked to complete the UAS for 4 weeks before each survey.
Item selection Impact analysis. The aim of the impact analysis was to exclude all potential UCT items with a low relevance for the patients. To this end, the participants in the item-selection phase specified in their evaluation forms which of the potential UCT items they had experienced during the last year (response options: yes or no) and rated the importance of each item
O much
O somewhat
O a little
O not at all
3. How often was the treatment for your urticaria in the last 4 weeks not enough to control your urticaria symptoms? O very often
O often
O sometimes
O seldom
O not at all
4. Overall, how well have you had your urticaria under control in the last 4 weeks? O not at all
O a little
O somewhat
O well
O very well
FIG 1. A, UCT: validated German version. B, UCT: linguistically validated AE version.
(response options: 1 5 not important to 5 5 extremely important). The item’s ‘‘frequency’’ was then computed as the proportion of respondents who had experienced the problem indicated in the respective item, whereas the item’s ‘‘importance’’ was computed as the mean of the response values for each item. Subsequently, the ‘‘impact’’ of each item was calculated by multiplication of ‘‘frequency’’ and ‘‘importance.’’ We considered an item to be of low relevance if the item impact score was 80 Unknown Disease duration (y)à 0-2 2-10 >10 Unknown§ Diagnosis CSU CSU plus CIndU CIndU Origin of data Paper-based survey Internet survey
UCT validation phase
No.
Percentage
No.
Percentage
390 115 3
76.8 22.6 0.6
78 42 —
65.0 35.0 —
25 215 211 52 3 2
4.9 42.3 41.5 10.2 0.6 0.4
10 37 51 22 — —
8.3 30.8 42.5 18.3 — —
— — — —
— — — —
47 65 7 1
39.2 54.2 5.8 0.8
253 159 96
49.8 31.3 18.9
72 28 20
60.0 23.3 16.7
175 333
34.4 65.6
—
—
*Three patients who completed the Internet survey provided no information on their sex. Two patients who completed the Internet survey provided no information on their age. àDisease duration was not obtained during the UCT item-selection phase. §One patient provided no information on disease duration.
of all patients for whom (1) 2 UCT scores were available and (2) both corresponding patient’s global ratings of disease severity (PatGA-LS) showed identical results by using the paired Student t test, as well as by computing the intraclass correlation coefficient (ICC). An ICC of 0.5 to 0.7 was considered to indicate moderate-to-good reproducibility, and an ICC of greater than 0.7 was considered to demonstrate excellent reproducibility.11
Linguistic validation of an American English version Two independent forward translations to American English (AE) were performed by native AE speakers bilingual in the source language (German) to obtain an AE version of the UCT. The 2 translations were then reconciled by a national American expert (Thomas B. Casale) and back-translated by a German native speaker. The backward translation was then compared with the original German UCT, and a final AE consensus version was agreed on by the national German and American experts. This version was then tested in 11 American patients who completed the UCT and were subjected to cognitive debriefing interviews.
Statistical analysis All statistical analyses were performed with SPSS software (IBM SPSS Statistics, version 19; IBM, Armonk, NY). The statistical methods applied are described at the respective Methods and Results sections of this article. A P value of .05 or less was considered statistically significant.
RESULTS This work resulted in a 4-question instrument (UCT), which is shown in Fig 1. In the following the results of the development process, including item generation, item reduction, and UCT validation, are described.
4 WELLER ET AL
J ALLERGY CLIN IMMUNOL nnn 2014
TABLE II. Item impact analysis (all patients, n 5 508) Item
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Item content (item category)
Frequency (%)
Importance (mean)
Impact
Severity of urticaria symptoms (pruritus and wheals) Frequency of urticaria symptoms (pruritus and wheals) Severity of pruritus Frequency of pruritus Severity of wheals Frequency of wheals Severity of impairment of work, spare time, and sports activities Frequency of impairment of work, spare time, and sports activities Severity of impairment of daily activities Frequency of impairment of daily activities Severity of sleep impairment Frequency of sleep impairment Severity of adverse effect on appearance Frequency of adverse effect on appearance Severity of embarrassment caused by urticaria symptoms Frequency of embarrassment caused by urticaria symptoms Severity of quality-of-life impairment Frequency of quality-of-life impairment Necessity of having to avoid physical triggers Frequency of having to avoid physical triggers Frequency of treatment being not sufficient Frequency of requirement for additional treatment Severity of unwanted drug side effects Frequency of unwanted drug side effects Rate of overall disease control
0.88 0.90 0.83 0.86 0.82 0.84 0.64 0.61 0.51 0.53 0.57 0.58 0.70 0.69 0.54 0.53 0.76 0.77 0.56 0.56 0.70 0.57 0.35 0.36 0.76
4.04 4.03 3.92 3.95 3.86 3.94 3.76 3.73 3.72 3.68 3.82 3.79 3.55 3.47 3.25 3.20 4.06 4.02 3.60 3.57 4.11 4.06 3.84 3.81 4.20
3.56 3.63 3.25 3.40 3.17 3.31 2.41 2.28 1.90 1.95 2.18 2.20 2.49 2.39 1.76 1.70 3.09 3.10 2.02 2.00 2.88 2.31 1.34 1.37 3.19
Patient sample characteristics Five hundred eight patients with chronic urticaria were included in the UCT item-selection phase (mean 6 SD age, 41.6 6 14.3 years) and 120 in the UCT validation phase (mean 6 SD age, 44.6 6 15.8 years; Table I). In total, 571 patients were recruited for the item-selection phase, but 63 data sets had to be excluded because their diagnosis was not confirmed by a physician (n 5 49) or because the patient had acute spontaneous urticaria (n 5 14). Of 123 patients who participated in the UCT validation phase, 2 had to be excluded from the analysis because of highly incomplete data sets and 1 patient because he had urticarial vasculitis but not chronic urticaria. UCT item selection During the item-generation phase, 25 items possibly relevant to assess disease control in patients with CSU and CIndU were identified. Each item asked the respondent to consider the previous 4 weeks. The impact analysis suggested to exclude items 9, 10, 15, 16, 23, and 24 (all impact
From athe Department of Dermatology and Allergy, Allergie-Centrum-Charite, Charite–Universit€atsmedizin Berlin; bthe Department of Dermatology, University Medical Center Mainz; cthe Institute for Clinical Epidemiology and Applied Biometry, Eberhard-Karls-University T€ubingen; and dthe Division of Allergy and Immunology, Creighton University, Omaha. Supported in part by the Urtikaria Network e.V. (UNEV) and Novartis Germany. Disclosure of potential conflict of interest: M. Maurer has received consultancy fees from Almirall, Bayer, Biofrontera, FAES, Genentech, GlaxoSmithKline, Recordati, Novartis, Sanofi Aventis, MSD, Moxie, UCB, and Uriach; is employed by Charite– Universit€atsmedizin Berlin; and has received research support from FAES, Genentech, Novartis, MSD, Moxie, UCB, and Uriach. The rest of the authors declare that they have no relevant conflicts of interest. Received for publication September 11, 2013; revised December 2, 2013; accepted for publication December 18, 2013. Corresponding author: Marcus Maurer, MD, Allergie-Centrum-Charite, Department of Dermatology and Allergy, Charite–Universit€atsmedizin Berlin, Chariteplatz 1, D-10117 Berlin, Germany. E-mail: [email protected]. 0091-6749/$36.00 Ó 2014 American Academy of Allergy, Asthma & Immunology http://dx.doi.org/10.1016/j.jaci.2013.12.1076
Abbreviations used AE: American English CIndU: Chronic inducible urticaria CSU: Chronic spontaneous urticaria CU-Q2oL: Chronic Urticaria Quality of Life Questionnaire ICC: Intraclass correlation coefficient LS: Likert scale PatGA: Patient’s global assessment PhyGA: Physician’s global assessment PRO: Patient-reported outcome ROC: Receiver operating characteristic UAS: Urticaria Activity Score UAS28: Urticaria Activity Score assessed for 28 days UCT: Urticaria Control Test VAS: Visual analog scale
Urticaria is a frequent skin disorder characterized by recurrent, transient, pruritic wheal and flare–type skin reactions, angioedema, or both.1 Every fifth person experiences at least 1 episode of any type of urticaria during his or her life.1 A recent study confirmed that office-based dermatologists, general practitioners, and pediatricians treat between 12 and 25 patients with urticaria every month.2 In addition, many patients (31%)2 are referred to and are treated by tertiary care centers.3 Accordingly, urticaria is of high relevance in real-life medical care. Assessing disease activity of patients with urticaria is a major problem because urticaria symptoms commonly fluctuate considerably from day to day. Therefore the clinical picture of a patient at the time of presentation to his or her treating physician is only rarely representative of the actual current disease status. As of yet, the only reliable way to assess current disease activity is the prospective determination of symptoms over several consecutive days with the Urticaria Activity Score (UAS).4 The UAS works as a daily diary quantifying wheals and itching. Although it proved to be a useful tool and became the gold standard for measuring disease activity in patients with chronic spontaneous urticaria (CSU),5 it has some major limitations. First, it works only as a prospective instrument and therefore cannot be used during a first patient contact. Second, its evaluation becomes problematic if patients forget its completion on single days. Third, it does not cover angioedema, which commonly occurs in patients with CSU or even as the only disease symptom of CSU. Fourth, it is designed only for patients with CSU and not other subtypes of chronic urticaria, such as chronic inducible urticaria (CIndU; eg, symptomatic dermographism, cholinergic urticaria, delayed pressure urticaria, and cold contact urticaria), although many patients have a combination of CSU and 1
2 WELLER ET AL
CIndU or CIndU alone. Finally, it has not been primarily developed to assess disease control. These limitations prompted us to develop a new, brief, and simple tool for quantifying disease control in all patients with all types of chronic urticaria and to aid treatment decisions. Additional properties of this new instrument should be that (1) it is a patient-based (patient-reported outcome [PRO]) instrument, (2) it is a retrospective tool that is independent of any previous patient presentations, (3) it is easy to administer and fast to complete, and (4) it is easy to score and interpret for the treating physicians. Here we report the development of such a tool, the Urticaria Control Test (UCT; Fig 1).
J ALLERGY CLIN IMMUNOL nnn 2014
A
Urtikariakontrolltest
Name: __________________________
Anleitung: Sie leiden unter einer Nesselsucht (Urtikaria). Mit den folgenden Fragen soll ihre aktuelle Krankheitssituation erfasst werden. Bitte lesen Sie sich jede Frage sorgfältig durch und wählen Sie aus den fünf Antworten diejenige aus, die für Sie am besten zutrifft. Bitte beziehen Sie sich dabei auf die vergangenen 4 Wochen. Überlegen Sie bitte nicht lange und denken Sie daran, alle Fragen zu beantworten und für jede Frage nur eine Antwort auszuwählen. 1. Wie sehr haben Sie in den vergangenen 4 Wochen unter den körperlichen Beschwerden der Urtikaria (Juckreiz, Quaddelbildung und/oder Schwellungen) gelitten? O sehr stark
The development of the UCT consisted of 3 main phases: (1) item generation, (2) item reduction, and (3) UCT validation. The development process of the well-established Asthma Control Test6 served as a model for our approach.
Item generation UCT item generation was performed by following current recommendations for PRO development.7 An expert working group was convened and helped to specify fields of urticaria control that should be assessed by the UCT, to guide the generation of specific survey questions, to define criterion measures of urticaria control (anchors) to be used for the evaluation of the survey’s performance, and to design and conduct the item-selection and validation studies. In addition, the literature was searched for existing PRO instruments in chronic urticaria and published information on how to best measure disease control. This was complemented by exploratory semistructured interviews with 10 patients with CSU and 5 patients with CIndU.
O stark
O mittelmäßig
O wenig
O gar nicht
2. Wie sehr war Ihre Lebensqualität in den vergangenen 4 Wochen wegen der Urtikaria beeinträchtigt? O sehr stark
METHODS
Datum: ____ . ____ . ________
Geburtsdatum: ____ . ____ . ________
O stark
O mittelmäßig
O wenig
O gar nicht
3. Wie oft hat die Therapie für Ihre Urtikaria in den vergangenen 4 Wochen nicht ausgereicht, um die Urtikariabeschwerden zu kontrollieren? O sehr oft
O oft
O gelegentlich
O selten
O gar nicht
4. Wie gut hatten Sie Ihre Urtikaria in den vergangenen 4 Wochen insgesamt unter Kontrolle? O gar nicht
O kaum
B
O mittelmäßig
O gut
O vollständig
Urticaria Control Test
Patient name: ___________________________
Date: (dd mmm yyyy): ___ ____ _____
Date of birth (dd mmm yyyy): ___ ____ _____
Instructions: You have urticaria. The following questions should help us understand your current health situation. Please read through each question carefully and choose an answer from the five options that best fits your situation. Please limit yourself to the last four weeks. Please don’t think about the questions for a long time, and do remember to answer all questions and to provide only one answer to each question. 1. How much have you suffered from the physical symptoms of the urticaria (itch, hives (welts) and/or swelling) in the last four weeks? O very much
O much
O somewhat
O a little
O not at all
2. How much was your quality of life affected by the urticaria in the last 4 weeks? O very much
Data collection during UCT item-selection and UCT validation phase Patients with chronic urticaria at 2 urticaria specialist centers (Berlin and Mainz, Germany) were recruited into the UCT item-selection (ClinicalTrials. gov identifier: NCT01610128) and UCT validation (ClinicalTrials.gov identifier: NCT01614834) phases. Participation in the item-selection phase was also possible online (recruitment through the Web page of the Urticaria Network e.V.: www.urtikaria.net). Each site’s local ethics committee approved the study, and all participants had to provide informed consent. The physician-based diagnosis of CSU, CIndU, or both was a prerequisite for inclusion. In the item-selection phase patients had to complete an evaluation form of all potential UCT items. On this form, they scored the frequency and importance, as well as the understandability, comprehensibility, and completeness, of the items. In addition, they provided information on their current level of disease control. In the UCT validation phase patients completed a survey twice (on days 0 and 28). The survey consisted of all final UCT items (items selected in the UCT item-selection phase, see below), global assessments of disease severity, disease control, and treatment sufficiency during the previous 4 weeks measured by using a visual analog scale (VAS) or a Likert scale (LS), the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), and questions on disease duration and sociodemographic characteristics. In addition, the patients were asked to complete the UAS for 4 weeks before each survey.
Item selection Impact analysis. The aim of the impact analysis was to exclude all potential UCT items with a low relevance for the patients. To this end, the participants in the item-selection phase specified in their evaluation forms which of the potential UCT items they had experienced during the last year (response options: yes or no) and rated the importance of each item
O much
O somewhat
O a little
O not at all
3. How often was the treatment for your urticaria in the last 4 weeks not enough to control your urticaria symptoms? O very often
O often
O sometimes
O seldom
O not at all
4. Overall, how well have you had your urticaria under control in the last 4 weeks? O not at all
O a little
O somewhat
O well
O very well
FIG 1. A, UCT: validated German version. B, UCT: linguistically validated AE version.
(response options: 1 5 not important to 5 5 extremely important). The item’s ‘‘frequency’’ was then computed as the proportion of respondents who had experienced the problem indicated in the respective item, whereas the item’s ‘‘importance’’ was computed as the mean of the response values for each item. Subsequently, the ‘‘impact’’ of each item was calculated by multiplication of ‘‘frequency’’ and ‘‘importance.’’ We considered an item to be of low relevance if the item impact score was 80 Unknown Disease duration (y)à 0-2 2-10 >10 Unknown§ Diagnosis CSU CSU plus CIndU CIndU Origin of data Paper-based survey Internet survey
UCT validation phase
No.
Percentage
No.
Percentage
390 115 3
76.8 22.6 0.6
78 42 —
65.0 35.0 —
25 215 211 52 3 2
4.9 42.3 41.5 10.2 0.6 0.4
10 37 51 22 — —
8.3 30.8 42.5 18.3 — —
— — — —
— — — —
47 65 7 1
39.2 54.2 5.8 0.8
253 159 96
49.8 31.3 18.9
72 28 20
60.0 23.3 16.7
175 333
34.4 65.6
—
—
*Three patients who completed the Internet survey provided no information on their sex. Two patients who completed the Internet survey provided no information on their age. àDisease duration was not obtained during the UCT item-selection phase. §One patient provided no information on disease duration.
of all patients for whom (1) 2 UCT scores were available and (2) both corresponding patient’s global ratings of disease severity (PatGA-LS) showed identical results by using the paired Student t test, as well as by computing the intraclass correlation coefficient (ICC). An ICC of 0.5 to 0.7 was considered to indicate moderate-to-good reproducibility, and an ICC of greater than 0.7 was considered to demonstrate excellent reproducibility.11
Linguistic validation of an American English version Two independent forward translations to American English (AE) were performed by native AE speakers bilingual in the source language (German) to obtain an AE version of the UCT. The 2 translations were then reconciled by a national American expert (Thomas B. Casale) and back-translated by a German native speaker. The backward translation was then compared with the original German UCT, and a final AE consensus version was agreed on by the national German and American experts. This version was then tested in 11 American patients who completed the UCT and were subjected to cognitive debriefing interviews.
Statistical analysis All statistical analyses were performed with SPSS software (IBM SPSS Statistics, version 19; IBM, Armonk, NY). The statistical methods applied are described at the respective Methods and Results sections of this article. A P value of .05 or less was considered statistically significant.
RESULTS This work resulted in a 4-question instrument (UCT), which is shown in Fig 1. In the following the results of the development process, including item generation, item reduction, and UCT validation, are described.
4 WELLER ET AL
J ALLERGY CLIN IMMUNOL nnn 2014
TABLE II. Item impact analysis (all patients, n 5 508) Item
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Item content (item category)
Frequency (%)
Importance (mean)
Impact
Severity of urticaria symptoms (pruritus and wheals) Frequency of urticaria symptoms (pruritus and wheals) Severity of pruritus Frequency of pruritus Severity of wheals Frequency of wheals Severity of impairment of work, spare time, and sports activities Frequency of impairment of work, spare time, and sports activities Severity of impairment of daily activities Frequency of impairment of daily activities Severity of sleep impairment Frequency of sleep impairment Severity of adverse effect on appearance Frequency of adverse effect on appearance Severity of embarrassment caused by urticaria symptoms Frequency of embarrassment caused by urticaria symptoms Severity of quality-of-life impairment Frequency of quality-of-life impairment Necessity of having to avoid physical triggers Frequency of having to avoid physical triggers Frequency of treatment being not sufficient Frequency of requirement for additional treatment Severity of unwanted drug side effects Frequency of unwanted drug side effects Rate of overall disease control
0.88 0.90 0.83 0.86 0.82 0.84 0.64 0.61 0.51 0.53 0.57 0.58 0.70 0.69 0.54 0.53 0.76 0.77 0.56 0.56 0.70 0.57 0.35 0.36 0.76
4.04 4.03 3.92 3.95 3.86 3.94 3.76 3.73 3.72 3.68 3.82 3.79 3.55 3.47 3.25 3.20 4.06 4.02 3.60 3.57 4.11 4.06 3.84 3.81 4.20
3.56 3.63 3.25 3.40 3.17 3.31 2.41 2.28 1.90 1.95 2.18 2.20 2.49 2.39 1.76 1.70 3.09 3.10 2.02 2.00 2.88 2.31 1.34 1.37 3.19
Patient sample characteristics Five hundred eight patients with chronic urticaria were included in the UCT item-selection phase (mean 6 SD age, 41.6 6 14.3 years) and 120 in the UCT validation phase (mean 6 SD age, 44.6 6 15.8 years; Table I). In total, 571 patients were recruited for the item-selection phase, but 63 data sets had to be excluded because their diagnosis was not confirmed by a physician (n 5 49) or because the patient had acute spontaneous urticaria (n 5 14). Of 123 patients who participated in the UCT validation phase, 2 had to be excluded from the analysis because of highly incomplete data sets and 1 patient because he had urticarial vasculitis but not chronic urticaria. UCT item selection During the item-generation phase, 25 items possibly relevant to assess disease control in patients with CSU and CIndU were identified. Each item asked the respondent to consider the previous 4 weeks. The impact analysis suggested to exclude items 9, 10, 15, 16, 23, and 24 (all impact
