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.

Keywords: Acromegaly; Clinician-reported outcomes; Instrument; Pilot study.

Fig. 1

Versions of the SAGIT instrument a used in Step 1 pre-testing (original version) and b following completion of Step 1 pre-testing and Step 2 pilot study

Fig. 1

Versions of the SAGIT instrument a used in Step 1 pre-testing (original version) and b following completion of Step 1 pre-testing and Step 2 pilot study

Fig. 2

Utility of the SAGIT instrument: results of PRAC-Test^® questionnaire during Step 1 pre-testing and Step 2 pilot study. Note that multiple responses were possible

Fig. 3

Practical aspects of the SAGIT instrument: results of the PRAC-Test^® questionnaire during Step 1 pre-testing and Step 2 pilot study. Note that multiple responses were possible

Fig. 4

Distribution of endocrinologists’ scores according to patients’ profiles (Step 2 pilot study; n = 26 patients)