Table 1.
Patient-reported outcomes
| PRO | Format (time span) | Domain | Scoring systema | Scoring range | Correlating response | MCID |
|---|---|---|---|---|---|---|
| Disease activity | ||||||
| UAS7 [23, 43] | Diary (based on the last 7 days) | Pruritus intensity and number of hives | 0–3 | 0–42b |
0 = Itch and hive free 1–6 = Well-controlled 7–15 = Mild activity 16–27 = Moderate activity 28–42 = Severe activity |
9.5–10.5 |
| AAS7 [53, 54] | Diary (based on the last 7 days) | Severity of physical discomfort, ability to perform daily activities, cosmetic impact, and global assessment of severity | 0–3 | 0–105b | – | 8 |
| Disease control | ||||||
| UCT [44, 45] | 4-item questionnaire (based on the last 4 weeks) | Physical symptoms, impact on QoL, treatment effectiveness, symptom control | 0–4 | 0–16 |
16 = Completely controlled 12–15 = Well-controlled < 12 = Uncontrolled |
3 |
| AECT [55] | 4-item questionnaire (based on the last 4 weeks) | Frequency of angioedema, angioedema-related QoL impairment, the unpredictability of angioedema attacks, and angioedema control by current treatment | 0–4 | 0–16 |
0–9 = Poorly controlled 10–16 = Controlled disease |
– |
| QoL impairments | ||||||
| CU-Q2oL [56, 57] | 23-item questionnaire (based on the last 2 weeks) | Pruritus, swelling, daily life activities, sleep, appearance, and limitations | 1–5 | 0–100 | – | 15 |
| AE-QoL [58, 59] | 17-item questionnaire (based on the last 4 weeks) | Functioning, fatigue/mood, fear/shame, and food | 1–5 | 0–100 | – | 6 |
| DLQI [60, 61] | 10-item questionnaire (based on the last 7 days) | Symptoms/feelings, daily activities, leisure, work or school, personal relationships, and treatment side effects | 0–3 | 0–30b |
0–1 = No impact 2–5 = Little impact 6–10 = Moderate impact 11–20 = Very high impact 21–30 = Extremely high impact |
4 |
Validated PROs to measure CSU symptom severity, disease control, and impact on QoL
AAS7 weekly Angioedema Activity Score, AECT Angioedema Control Test, AE-QoL Angioedema Quality of Life Questionnaire, CSU chronic spontaneous urticaria, CU-Q2oL Chronic Urticaria Quality of Life Questionnaire, DLQI Dermatology Life Quality Index, QoL health-related quality of life, HSS7 weekly Hives Severity Score, ISS7 weekly Itch Severity Score, MCID minimal clinically important difference, PRO patient-reported outcome, QoL quality of life, UAS7 weekly Urticaria Activity Score, UCT Urticaria Control Test
aEach question is scored between the range
bHigher scores for the PRO indicate a worse outcome