International Multicenter Validation Study of the SAGIT® Instrument in Acromegaly

Context: The SAGIT (R) instrument (SAGIT) has been developed to enable accurate characterization of acromegaly disease activity.Objective: We evaluated the ability of SAGIT to discriminate acromegaly disease control status.Methods: This multicenter, noninterventional, prospective and retrospective, longitudinal study, conducted at academic and private clinical practice sites, included patients aged >= 18 years with a diagnosis of controlled (n = 109) or non-controlled (n = 105) acromegaly, assessed by clinical global evaluation of disease control (CGE-DC) questionnaire, investigator therapeutic decision, and international guidelines. Control status was not determined at baseline for 13 patients. Since 9 patients were enrolled retrospectively, all presented analyses are based on the prospective population (N = 227). Patients were assessed over a 2-year follow-up period. Classification and regression tree (CART) analyses were performed to investigate how SAGIT components at baseline (signs/symptoms [S], associated comorbidities [A], growth hormone levels [G], insulin-like growth factor 1 levels [II, tumor features [T]) discriminate between controlled and non-controlled acromegaly.Results: Baseline mean subscores S, G, I, andT were significantly lower in patients with CGE-DC controlled vs CGE-DC non-controlled acromegaly. SAGIT components I and G for CGE-DC and S, A, G, I, andT for the clinician's therapeutic decision were retained by CART analyses. For international guidelines, only SAGIT component I was retained.The risk for undergoing >= 1 treatment change during the study was 3.44 times greater for CGE-DC non-controlled acromegaly relative to CGE-DC controlled acromegaly.Conclusion: The SAGIT instrument is a valid and sensitive tool to comprehensively and accurately assess acromegaly severity.