Development and validation of a patient symptom questionnaire to facilitate early diagnosis of thyroid-associated orbitopathy in graves' disease.

BACKGROUND: To construct a patient-based symptom questionnaire to facilitate early referral of thyroid-associated orbitopathy (TAO) in Graves' hyperthyroidism (GH).

METHODS: Phase I of our study involved developing a symptomatology-based questionnaire for the self-reporting of TAO symptoms in patients recently diagnosed with GH. Phase II involved administering the questionnaire along with a standard ophthalmic examination to a screening cohort of patients newly diagnosed with GH. Symptoms highly associated with the clinical diagnosis of TAO were used to construct a tool with the highest possible sensitivity. Phase III involved validation of this tool in a new cohort of patients recently diagnosed with GH. For each patient, the diagnosis of TAO was made by both a standardized orbital ophthalmic exam and the questionnaire. Results from the questionnaire were then compared to the clinical examination.

RESULTS: The questionnaire was compared to the standardized examination and found to have a sensitivity of 0.76 and a specificity of 0.82 in the validation phase of the study.

INTERPRETATION: This questionnaire may be a useful tool in clinical practice to allow identification of patients with TAO secondary to GH. Future studies using this questionnaire are needed to determine whether earlier identification and management of these patients is associated with reduced morbidity from TAO.