Chronic Urticaria
Conditions
Keywords
Chronic urticaria, CU-Q2oL
Brief summary
In the majority of patients with the chronic urticaria, the etiology is unclear, leading to difficulties in treatment and high rates of recurrence. According to the International EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management is the key for a better treatment outcome. To translate this questionnaire into Thai is essential in our subject of interest in order to effectively apply it to local patients. The Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.
Detailed description
1. Adaption of the Cu-Q2oL questionnaire into Thai version by using forward-backward translation that is independently performed by two bilingual translators. The original Italian version is translated into Thai by two Thai native speakers, then the study team reviews the Thai-version Cu-Q2oL questionnaire for items comprehensibility and integrates the first consensus version which re-translated into Italian by an Italian native speaker afterwards. The comparison between the backward Italian version Cu-Q2oL questionnaire and the original Cu-Q2oL is carried out to find out whether there are any misconception and mistranslation in the intermediary forward version of questionnaire. After that, the second consensus version will be tested on 15 chronic urticaria patients to detect any misunderstanding points based on patients' comments. Finally, this Thai-version of CU-Q2oL questionnaire will be used to investigate the validity, reliability, interpretability and minimal clinical important difference. 2. To investigate the validity, reliability and interpretability of Thai-version of Chronic Urticaria Quality of Life Questionaire (CU-Q2oL), the severity of chronic urticaria symptoms will be assessed by investigators and patients using the Urticaria Activity Score (UAS7), the DLQI and CU-Q2oL questionnaire.
Interventions
OTHERCU-Q2oL
The patients will be explained how to complete the Urticaria Activity Score (UAS7) form for evaluating their severity of chronic urticaria symptoms at home. At the 2nd visit, collect the 1st UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 1st DLQI and CU-Q2oL questionnaire and get the 2nd UAS7 form and two-week appointment to follow up. At the 3th visit, collect the 2nd UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 2nd DLQI and CU-Q2oL questionnaire.
Sponsors
University of Genua, Italy
Mahidol University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years old or above * Diagnosed as chronic urticaria based on The EAACI/GA(2)LEN/EDF/WAO Guideline * Literate in Thai language and can complete the questionnaire by themselves
Exclusion criteria
* Have other active skin diseases * Have a psychiatric problem * Cannot understand the questionnaire by themselves.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cross-Cultural Validity of Thai-version CU-Q2oL | 4 week | Cross-cultural validity is the degree to which the performance of the Thai CU-Q2oL items can adequately reflect the performance of the original CU-Q2oL items. Exploratory factor analysis was used to determine scales with proper item division of the Thai CU-Q2oL. Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL | baseline | \- The CU-Q2oL Questionnaire is a 23-item HRQoL questionnaire. It measures three dimensions (scales) of HRQoL: domain I (sleep, leisure, concentration), domain II (symptom, eating limits), and domain III (mental status, looks, impact on life activities) The scores of domain I of CUQ2oL range between 0 and 26. The scores of domain II of CUQ2oL range between 0 and 39.The scores of domain III of CUQ2oL between 0 and 35. The minimum possible score is 0 and the maximum possible score is 100 for total scale. -The DLQI scores range from 0-30. Domain I (leisure), Domain II (symptoms and feeling), and Domain III (daily activities, work, school, and personal relationships). Meaning of DLQI Scores: 0-1 = no effect, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, 21-30 = extremely large effect. The higher the score, the more quality of life is impaired for both the CUQ2oL and the DLQI. |
| Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders | baseline and 2 weeks | \- Investigate the smallest reduction in the Thai CU-Q2oL that patients recognized as a meaningful improvement. |
| Area Under the Curve for Thai CUQ2oL Scores in the Responder Group | baseline and 2 weeks | The receiver operating characteristic (ROC) analysis and area under the curve (AUC) are acceptable as the units of measure for assess the ability of a questionnaire to changes in patients' health-related quality of life (HRQoL) impairment over time that represents to responsiveness to change and minimal clinical important difference (MCID). The AUC of the ROC analysis of 1, 0.9, 0.8, 0.7 and 0.5 were considered perfect, excellent, good, fair, and no better than chance, respectively. |
Countries
Thailand
Participant flow
Recruitment details
Patients diagnosed as chronic idiopathic urticaria were invited to participate in the study at the Allergy clinic in the Department of Dermatology, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Participants by arm
| Arm | Count |
|---|---|
| Chronic Idiopathic Urticaria Patients * Evaluation by the Urticaria Activity Score (UAS7)
* Fill the DLQI and CU-Q2oL questionnaire
CU-Q2oL: The patients diagnosed as chronic idiopathic urticaria will be explained how to complete the Urticaria Activity Score (UAS7) form for evaluating their severity of chronic urticaria symptoms at home.
At the 2nd visit, collect the 1st UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 1st DLQI and CU-Q2oL questionnaire and get the 2nd UAS7 form and two-week appointment to follow up.
At the 3th visit, collect the 2nd UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 2nd DLQI and CU-Q2oL questionnaire. | 166 |
| Total | 166 |
Baseline characteristics
| Characteristic | Chronic Idiopathic Urticaria Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 166 Participants |
| CU-Q2OL | 19.91 units on a scale STANDARD_DEVIATION 15.9 |
| Dermatology Life Quality Index | 4.67 Score STANDARD_DEVIATION 5.3 |
| Education | 166 participants |
| Region of Enrollment Thailand | 166 participants |
| Sex: Female, Male Female | 131 Participants |
| Sex: Female, Male Male | 35 Participants |
| Urticaria Activity Score | 8.8 units on a scale STANDARD_DEVIATION 9.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 166 |
| serious Total, serious adverse events | 0 / 166 |
Outcome results
Primary
Cross-Cultural Validity of Thai-version CU-Q2oL
Cross-cultural validity is the degree to which the performance of the Thai CU-Q2oL items can adequately reflect the performance of the original CU-Q2oL items. Exploratory factor analysis was used to determine scales with proper item division of the Thai CU-Q2oL. Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.
Time frame: 4 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extraction Sums of Square Loading (% of Variance) | Cross-Cultural Validity of Thai-version CU-Q2oL | Domain I (item 7,8,11-14 of CUQoL) | 43.71 Percentage |
| Extraction Sums of Square Loading (% of Variance) | Cross-Cultural Validity of Thai-version CU-Q2oL | Domain II( Item 1-6, 9-10, 17 of CUQoL) | 9.41 Percentage |
| Extraction Sums of Square Loading (% of Variance) | Cross-Cultural Validity of Thai-version CU-Q2oL | Domain III (Item 15-16, 18-23 of CUQoL) | 7.33 Percentage |
| Rotation Sums of Squared Loading (% of Variance) | Cross-Cultural Validity of Thai-version CU-Q2oL | Domain I (item 7,8,11-14 of CUQoL) | 22.11 Percentage |
| Rotation Sums of Squared Loading (% of Variance) | Cross-Cultural Validity of Thai-version CU-Q2oL | Domain II( Item 1-6, 9-10, 17 of CUQoL) | 20.21 Percentage |
| Rotation Sums of Squared Loading (% of Variance) | Cross-Cultural Validity of Thai-version CU-Q2oL | Domain III (Item 15-16, 18-23 of CUQoL) | 18.13 Percentage |
Comparison: Exploratory factor analysisp-value: <0.01exploratory factor analysis
Secondary
Area Under the Curve for Thai CUQ2oL Scores in the Responder Group
The receiver operating characteristic (ROC) analysis and area under the curve (AUC) are acceptable as the units of measure for assess the ability of a questionnaire to changes in patients' health-related quality of life (HRQoL) impairment over time that represents to responsiveness to change and minimal clinical important difference (MCID). The AUC of the ROC analysis of 1, 0.9, 0.8, 0.7 and 0.5 were considered perfect, excellent, good, fair, and no better than chance, respectively.
Time frame: baseline and 2 weeks
Population: Responder group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Extraction Sums of Square Loading (% of Variance) | Area Under the Curve for Thai CUQ2oL Scores in the Responder Group | 0.90 probability |
Secondary
Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders
\- Investigate the smallest reduction in the Thai CU-Q2oL that patients recognized as a meaningful improvement.
Time frame: baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extraction Sums of Square Loading (% of Variance) | Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders | 7.3 score | Standard Deviation 9.4 |
| Rotation Sums of Squared Loading (% of Variance) | Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders | 28.4 score | Standard Deviation 15.3 |
Secondary
Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL
\- The CU-Q2oL Questionnaire is a 23-item HRQoL questionnaire. It measures three dimensions (scales) of HRQoL: domain I (sleep, leisure, concentration), domain II (symptom, eating limits), and domain III (mental status, looks, impact on life activities) The scores of domain I of CUQ2oL range between 0 and 26. The scores of domain II of CUQ2oL range between 0 and 39.The scores of domain III of CUQ2oL between 0 and 35. The minimum possible score is 0 and the maximum possible score is 100 for total scale. -The DLQI scores range from 0-30. Domain I (leisure), Domain II (symptoms and feeling), and Domain III (daily activities, work, school, and personal relationships). Meaning of DLQI Scores: 0-1 = no effect, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, 21-30 = extremely large effect. The higher the score, the more quality of life is impaired for both the CUQ2oL and the DLQI.
Time frame: baseline
Population: Mean score of domain I, II, III of Thai CU-Q2oL were correlated to mean score domain I, II, III of Thai DLQI, respectively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extraction Sums of Square Loading (% of Variance) | Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL | Domain I | 23.19 units on a scale | Standard Deviation 21.7 |
| Extraction Sums of Square Loading (% of Variance) | Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL | Domain II | 19.09 units on a scale | Standard Deviation 16.6 |
| Extraction Sums of Square Loading (% of Variance) | Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL | Domain III | 18.37 units on a scale | Standard Deviation 17.5 |
| Rotation Sums of Squared Loading (% of Variance) | Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL | Domain I | 1.86 units on a scale | Standard Deviation 1.4 |
| Rotation Sums of Squared Loading (% of Variance) | Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL | Domain II | 1.79 units on a scale | Standard Deviation 1.5 |
| Rotation Sums of Squared Loading (% of Variance) | Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL | Domain III | 1.85 units on a scale | Standard Deviation 2.5 |
p-value: <0.05Crohbach's alpha