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. 2018 Oct 1;154(10):1137-1144.
doi: 10.1001/jamadermatol.2018.1165.

Identifying a Core Domain Set to Assess Psoriasis in Clinical Trials

Kristina Callis Duffin  1 , Joseph F Merola  2   3 , Robin Christensen  4 , John Latella  5 , Amit Garg  6 , Alice B Gottlieb  7 , April W Armstrong  8   9
Affiliations

Identifying a Core Domain Set to Assess Psoriasis in Clinical Trials

Kristina Callis Duffin et al. JAMA Dermatol. .

Abstract

Importance: There is no consensus on which domains should be measured or which instruments should be used in clinical trials for psoriasis therapies.

Objective: To achieve international consensus among psoriasis stakeholders on a core set of domains that should be measured in all psoriasis clinical trials.

Design, setting, and participants: Literature review, pre-Delphi survey exercises, nominal group discussions, and audience voting at 4 stakeholder meetings were used to develop candidate domains for 2 rounds of a Delphi survey. Stakeholders were patients or advocates of patients with psoriasis and health care professionals (HCPs) with expertise in psoriasis, including physicians, scientists, advocacy organization representatives, and regulators. Delphi surveys were conducted electronically from October through December 2015 and between September and October 2016. Stakeholder discussions with audience response voting were conducted at live meetings in the United States, Canada, and Italy from January 2013 to December 2016 to refine and ratify the core set of domains.

Main outcomes and measures: Two rounds of an electronic Delphi survey were used to determine consensus. A domain was considered "core" (ie, should be measured in all trials) if a threshold consensus of at least 70% was met in both patient and HCP groups. Domains meeting consensus in only 1 group were considered to be important but were not required to be measured in all trials ("middle ring"). These domains were included for rerating in round 2. Domains that did not meet consensus in either of the groups ("outer ring") were considered to be of uncertain importance and were placed in the research agenda.

Results: In round 1 of the Delphi survey, 107 HCPs and 14 patients participated. Most HCPs (72 [67%]) were dermatologists between 46 and 64 years old (71 [66%]), white (78 [73%]), and male (75 [70%]) from North America (60 [57%]) and Europe (34 [32%]).There were 10 pharmaceutical industry clinical or health economic scientists, 3 advocacy organization representatives, 2 regulatory agency representatives, and 5 "other." In the second round, 77 HCPs and 15 patients participated. Of the 20 candidate domains, the following 6 met consensus as core domains: skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global assessment, patient global assessment, and treatment satisfaction. Secondary skin manifestations as well as nail, inverse, genital, and guttate psoriasis were classified as important but not mandatory. Psoriatic arthritis signs, work productivity or participation, economic impact (direct and indirect cost), and cardiovascular disease comprised the research agenda.

Conclusions and relevance: This iterative Delphi process yielded international consensus among professional and patient stakeholders on 6 domains that should be measured in all clinical trials for psoriasis. Future International Dermatology Outcome Measures group efforts will focus on development of a core outcome measurement set for psoriasis trials.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Callis Duffin reported serving as a paid investigator, advisor, or consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly and Company, Novartis, Pfizer, Regeneron, Sienna Biopharmaceuticals, and Stiefel Laboratories. Dr Merola reported serving as a paid consultant for Biogen Inc, AbbVie, Eli Lilly and Company, Novartis, Pfizer, Janssen, UCB, Sumumed, Science 37, Celgene, Sanofi, Regeneron, and GlaxoSmithKline plc; as a paid speaker for AbbVie; as a paid investigator for Biogen Inc, Pfizer, Sanofi, Regeneron, Incyte Corp, and Novartis; and has licensed outcome measures to AbbVie and Eli Lilly and Company. Dr Christensen is employed by The Parker Institute, Bispebjerg and Frederiksberg Hospital, which is supported by a core grant from the Oak Foundation. Dr Garg reported serving as a paid consultant and investigator for AbbVie and as a paid investigator for Merck. Dr Gottlieb reported serving as a paid consultant or advisor for Janssen, Celgene, Bristol-Myers Squibb, Beiersdorf, AbbVie, UCB, Novartis, Incyte Corp, Eli Lilly and Company, Dr Reddy’s Laboratories, Valeant Pharmaceuticals International Inc, Dermira, Allergan, and Sun Pharmaceutical Industries Ltd. She has received research grants from Janssen and Incyte Corp. Dr Armstrong reported serving as a paid investigator and advisor/consultant for AbbVie, Janssen, Novartis, Celgene, Eli Lilly and Company, Pfizer, Regeneron, Sanofi, Modernizing Medicine, and Science 37.

Figures

Figure 1.
Figure 1.. Schematic Depicting the International Dermatology Outcome Measures (IDEOM) Consensus Process for Core Domains in Psoriasis Clinical Trials
A literature review was conducted and meetings were held to determine candidate items, followed by conceptualization of items into domains. Delphi surveys and live meetings were conducted to finalize the core domain set. IDEOM indicates International Dermatology Outcome Measures; OMERACT, Outcome Measures in Rheumatology.
Figure 2.
Figure 2.. Onion Model of Core Domains for Psoriasis Clinical Trials
The inner ring (left) includes the 6 core domains that are considered required to measure in every psoriasis clinical trial. The middle ring includes 1 domain (skin manifestations) with 5 subdomains that are not required but may be important depending on the study objectives. The outer ring (right) includes 4 domains that are considered the “research agenda,” or items that may be important but need further study. BSA indicates body surface area.
See this image and copyright information in PMC

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