Development of criteria for evaluating clinical response in thyroid eye disease using a modified Delphi technique.
OBJECTIVE
To identify components of a provisional clinical response index for thyroid eye disease using a modified Delphi technique.


METHODS
The International Thyroid Eye Disease Society conducted a structured, 3-round Delphi exercise establishing consensus for a core set of measures for clinical trials in thyroid eye disease. The steering committee discussed the results in a face-to-face meeting (nominal group technique) and evaluated each criterion with respect to its feasibility, reliability, redundancy, and validity. Redundant measures were consolidated or excluded.


RESULTS
Criteria were parsed into 11 domains for the Delphi surveys. Eighty-four respondents participated in the Delphi 1 survey, providing 220 unique items. Ninety-two members (100% of the respondents from Delphi 1 plus 8 new participants) responded in Delphi 2 and rated the same 220 items. Sixty-four members (76% of participants) rated 153 criteria in Delphi 3 (67 criteria were excluded because of redundancy). Criteria with a mean greater than 6 (1 = least appropriate to 9 = most appropriate) were further evaluated by the nominal group technique and provisional core measures were chosen.


CONCLUSIONS
Using a Delphi exercise, we developed provisional core measures for assessing disease activity and severity in clinical trials of therapies for thyroid eye disease. These measures will be iteratively refined for use in multicenter clinical trials.
Douglas
Raymond S
RS
Department of Ophthalmology, Jules Stein Eye Institute and David Geffen School of Medicine at University of California, Los Angeles, CA 90095, USA.
Tsirbas
Angelo
A
Gordon
Mark
M
Lee
Diana
D
Khadavi
Nicole
N
Garneau
Helene Chokron
HC
Goldberg
Robert A
RA
Cahill
Kenneth
K
Dolman
Peter J
PJ
Elner
Victor
V
Feldon
Steve
S
Lucarelli
Mark
M
Uddin
Jimmy
J
Kazim
Michael
M
Smith
Terry J
TJ
Khanna
Dinesh
D
D002986:Clinical Trials as Topic; D032921:Consensus; D003697:Delphi Technique; D004704:Endocrinology / Q000458:organization & administration; D023381:Endpoint Determination; D049970:Graves Ophthalmopathy / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D009885:Ophthalmology / Q000458:organization & administration; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D012955:Societies, Medical / Q000592:standards; D016896:Treatment Outcome