SAGIT®: clinician-reported outcome instrument for managing acromegaly in clinical practice--development and results from a pilot study.

Abstract

PURPOSE:

The SAGIT instrument is a comprehensive clinician-reported outcome instrument assessing key features of acromegaly: signs and symptoms, associated comorbidities; growth hormone levels; insulin-like growth factor-1 levels; and tumor profile. The SAGIT instrument has been designed to assist endocrinologists managing acromegaly in practice. Here, we report on pre-testing (to assess ease of understanding and acceptability) and a pilot study (to assess relevance, ease of use, and utility in real-life conditions) (NCT02231593).

METHODS:

For pre-testing, 11 endocrinologists completed the SAGIT instrument using patient medical records and were also interviewed. They subsequently completed a PRAgmatic Content and face validity Test (PRAC-Test(©)) to report their experiences using SAGIT, and feedback was used to revise the instrument. In the pilot study, nine endocrinologists completed the SAGIT instrument in real-time with patients belonging to three different categories (stable/controlled, active/uncontrolled acromegaly, treatment-naïve), while four completed the instrument based on medical-record review. All participants then completed the PRAC-Test(©) and their feedback was used to update the instrument.

RESULTS:

The SAGIT instrument was well accepted by endocrinologists, with most indicating that it was concise, practical, easy to understand, useful for assessing treatment response, and valuable as a component of the patient's medical record. The pilot study confirmed the instrument's acceptability, utility, and ease of use, and indicated its potential for distinguishing acromegaly clinical stages.

CONCLUSIONS:

The SAGIT instrument is promising as a tool for use by endocrinologists in everyday practice to assess the status and evolution of disease in patients with acromegaly and to guide treatment decision-making.

• Authors: Andrea Giustina, John S Bevan, Marcello D Bronstein, Felipe F Casanueva, Philippe Chanson, Stephan Petersenn, Xuan-Mai Truong Thanh, Caroline Sert, Aude Houchard, Isabelle Guillemin, Shlomo Melmed, SAGIT Investigator Group
• Journal: Pituitary (Pituitary) Vol. 19 Issue 1 Pg. 39-49 (Feb 2016) ISSN: 1573-7403 [Electronic] United States
• PMID: 26377024 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Topics

• Acromegaly (diagnosis)
• Diagnostic Tests, Routine (instrumentation)
• Female
• Health Personnel
• Humans
• Male
• Pilot Projects