CLINICIAN GLOBAL IMPRESSION OF SEVERITY AND CHANGE SCALES FOR CUTANEOUS LUPUS ERYTHEMATOSUS: COGNITIVE DEBRIEFING EVIDENCE SUPPORTING CLINICAL UTILITY
Author(s)
Tina O'Donnell, PhD1, Josephine Park, MPH, MBA2, Patricia Koochaki, PhD1, Ufuk Z Coskun, PhD3, Denise Bury, MPH, PhD4, Paul Kamudoni, PhD5.
1ICON PLC, Dublin, Ireland, 2EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany, 3Sprout Health Solutions, Los Angeles, CA, USA, 4Independent COA Consultant under contract with Merck Healthcare KGaA, Darmstadt, Germany, 5Merck Healthcare KGaA, Darmstadt, Germany.
1ICON PLC, Dublin, Ireland, 2EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany, 3Sprout Health Solutions, Los Angeles, CA, USA, 4Independent COA Consultant under contract with Merck Healthcare KGaA, Darmstadt, Germany, 5Merck Healthcare KGaA, Darmstadt, Germany.
OBJECTIVES: Two novel clinician-reported global scales—the Cutaneous Lupus Disease Activity Physician Global Impression of Severity (CDA-PGIS) and the Physician Global Impression of Change (CDA-PGIC) were developed to support interpretation of meaningful within-person change in clinical outcome assessment (COA) scores in cutaneous lupus trials. The CDA-PGIS is a single-item, 4-point, verbal rating scale (VRS) assessing overall current disease severity ranging from 1 (None) to 4 (Severe). The CDA-PGIC, also a single-item, 7-point VRS assesses overall change in disease activity since study start ranging from 0 (Much better) to 6 (Much worse). Both scales define cutaneous lupus disease activity as erythema, scale or hypertrophy, mucosal membrane lesions, hair loss, and alopecia.
METHODS: Clinician cognitive debriefing interviews were conducted to evaluate content validity, comprehension, item clarity and relevance, recall period appropriateness and ease of completion of both scales. Clinicians also provided estimates of meaningful within-person change score thresholds for the CDA-PGIS.
RESULTS: Eighteen clinicians (9 dermatologists, 8 rheumatologists, and 1 dual specialist from the US (61%) and (Europe) participated in the cognitive debriefing interviews. Most clinician participants reported the measures easy to complete (88.9% and 92.9%) for CDA-PGIS and CDA-PGIC respectively. The CDA-PGIS recall period was considered appropriate by 83.3% of clinician participants. Response options were deemed suitable by 92.3% and 86.7% of clinician participants for the CDA-PGIS and the CDA-PGIC respectively. Most (78.6%) clinician participants viewed a 1-point improvement on the CDA-PGIS as a clinically meaningful change.
CONCLUSIONS: Cognitive debriefing supports the content validity, clarity and usability of both the CDA-PGIS and the CDA-PGIC. Most clinician participants reported the response options for both measures suitable, and easy to complete. The recall period for the CDA-PGIS was considered appropriate, with a 1-point change on the CDA-PGIS serving as an empirically grounded threshold for future anchor-based COA analyses in lupus clinical trials.
METHODS: Clinician cognitive debriefing interviews were conducted to evaluate content validity, comprehension, item clarity and relevance, recall period appropriateness and ease of completion of both scales. Clinicians also provided estimates of meaningful within-person change score thresholds for the CDA-PGIS.
RESULTS: Eighteen clinicians (9 dermatologists, 8 rheumatologists, and 1 dual specialist from the US (61%) and (Europe) participated in the cognitive debriefing interviews. Most clinician participants reported the measures easy to complete (88.9% and 92.9%) for CDA-PGIS and CDA-PGIC respectively. The CDA-PGIS recall period was considered appropriate by 83.3% of clinician participants. Response options were deemed suitable by 92.3% and 86.7% of clinician participants for the CDA-PGIS and the CDA-PGIC respectively. Most (78.6%) clinician participants viewed a 1-point improvement on the CDA-PGIS as a clinically meaningful change.
CONCLUSIONS: Cognitive debriefing supports the content validity, clarity and usability of both the CDA-PGIS and the CDA-PGIC. Most clinician participants reported the response options for both measures suitable, and easy to complete. The recall period for the CDA-PGIS was considered appropriate, with a 1-point change on the CDA-PGIS serving as an empirically grounded threshold for future anchor-based COA analyses in lupus clinical trials.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO231
Topic
Clinical Outcomes
Topic Subcategory
Clinician Reported Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas