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Raymond S. Douglas, MD, PhD; Angelo Tsirbas, MD; Mark Gordon, JD, MA; Diana Lee, BA; Nicole Khadavi, BS; Helene Chokron Garneau, BA; Robert A. Goldberg, MD; Kenneth Cahill, MD; Peter J. Dolman, MD, RCSC; Victor Elner, MD, PhD; Steve Feldon, MD; Mark Lucarelli, MD; Jimmy Uddin, MA, FRCOphth; Michael Kazim, MD; Terry J. Smith, MD; Dinesh Khanna, MD, MS; for the International Thyroid Eye Disease Society

Arch Ophthalmol. 2009;127(9):1155-1160.

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.

Author Affiliations: Jules Stein Eye Institute (Drs Douglas, Tsirbas, Goldberg, Smith, and Khanna, Mr Gordon, and Mss Lee, Khadavi, and Garneau) and David Geffen School of Medicine at University of California, Los Angeles (Drs Douglas, Goldberg, and Smith), and Greater Los Angeles Veterans Hospital (Dr Douglas), Los Angeles, and Division of Molecular Medicine, Department of Medicine, Harbor–University of California, Los Angeles, Medical Center, Torrance (Drs Douglas and Smith); Ohio State University, Columbus (Dr Cahill); University of British Columbia, Vancouver, British Columbia, Canada (Dr Dolman); University of Michigan Health Systems, Ann Arbor (Dr Elner); University of Rochester School of Medicine and Dentistry and University of Rochester Eye Institute, Rochester (Dr Feldon), and Columbia University, New York (Dr Kazim), New York; University of Wisconsin–Madison (Dr Lucarelli); and Moorfields Eye Hospital, London, England (Mr Uddin).

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