Trial Outcomes & Findings for The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire (NCT NCT02285023)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

166 participants

Primary outcome timeframe

4 week

Results posted on

2019-02-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	CU-Q2oL * Evaluation by the Urticaria Activity Score (UAS7) * Fill the DLQI and CU-Q2oL questionnaire CU-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.
Overall Study STARTED	166
Overall Study COMPLETED	166
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Idiopathic Urticaria Patients n=166 Participants * 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	166 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	131 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment Thailand	166 participants n=5 Participants
Urticaria Activity Score	8.8 units on a scale STANDARD_DEVIATION 9.6 • n=5 Participants
Dermatology Life Quality Index	4.67 Score STANDARD_DEVIATION 5.3 • n=5 Participants
CU-Q2OL	19.91 units on a scale STANDARD_DEVIATION 15.9 • n=5 Participants
Education	166 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Extraction Sums of Square Loading (% of Variance) n=166 Participants % of Variance - This column contains the percent of total variance accounted for by each factor.	Rotation Sums of Squared Loading (% of Variance) n=166 Participants The "% of variance" column tells you how much of the total variability (in all of the variables together) can be accounted for by each of these summary scales or factors.
Cross-Cultural Validity of Thai-version CU-Q2oL Domain I (item 7,8,11-14 of CUQoL)	43.71 Percentage	22.11 Percentage
Cross-Cultural Validity of Thai-version CU-Q2oL Domain II( Item 1-6, 9-10, 17 of CUQoL)	9.41 Percentage	20.21 Percentage
Cross-Cultural Validity of Thai-version CU-Q2oL Domain III (Item 15-16, 18-23 of CUQoL)	7.33 Percentage	18.13 Percentage

SECONDARY outcome

Timeframe: 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

\- 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.

Outcome measures

Outcome measures
Measure	Extraction Sums of Square Loading (% of Variance) n=166 Participants % of Variance - This column contains the percent of total variance accounted for by each factor.	Rotation Sums of Squared Loading (% of Variance) n=166 Participants The "% of variance" column tells you how much of the total variability (in all of the variables together) can be accounted for by each of these summary scales or factors.
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	1.86 units on a scale Standard Deviation 1.4
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	1.79 units on a scale Standard Deviation 1.5
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	1.85 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: baseline and 2 weeks

\- Investigate the smallest reduction in the Thai CU-Q2oL that patients recognized as a meaningful improvement.

Outcome measures

Outcome measures
Measure	Extraction Sums of Square Loading (% of Variance) n=17 Participants % of Variance - This column contains the percent of total variance accounted for by each factor.	Rotation Sums of Squared Loading (% of Variance) n=54 Participants The "% of variance" column tells you how much of the total variability (in all of the variables together) can be accounted for by each of these summary scales or factors.
Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders	7.3 score Standard Deviation 9.4	28.4 score Standard Deviation 15.3

SECONDARY outcome

Timeframe: baseline and 2 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Extraction Sums of Square Loading (% of Variance) n=17 Participants % of Variance - This column contains the percent of total variance accounted for by each factor.	Rotation Sums of Squared Loading (% of Variance) The "% of variance" column tells you how much of the total variability (in all of the variables together) can be accounted for by each of these summary scales or factors.
Area Under the Curve for Thai CUQ2oL Scores in the Responder Group	0.90 probability Interval 0.84 to 0.97	—

Adverse Events

Chronic Idiopathic Urticaria

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Kanokvalai Kulthanan

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Phone: (662)419-4333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place