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

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, Felipe Henning Gaia Duarte, Raquel S Jallad, Cesar Luiz Boguszewski, Antonio Ribeiro de Oliveira, Philippe Chanson, Christine Cortet, Françoise Galland, Sylvie Salenave, Jens Aberle, Sylvere Störmann, Rita Berardelli, Silvia Grottoli, Gherardo Mazziotti, Teresa Porcelli, Ignacio Bernabeu, Fernando Cordido, Silvia Maraver, Isabel Salinas, Prakash Abraham, Daniel Flanagan, Robert Murray, Sam Philip, 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, Felipe Henning Gaia Duarte, Raquel S Jallad, Cesar Luiz Boguszewski, Antonio Ribeiro de Oliveira, Philippe Chanson, Christine Cortet, Françoise Galland, Sylvie Salenave, Jens Aberle, Sylvere Störmann, Rita Berardelli, Silvia Grottoli, Gherardo Mazziotti, Teresa Porcelli, Ignacio Bernabeu, Fernando Cordido, Silvia Maraver, Isabel Salinas, Prakash Abraham, Daniel Flanagan, Robert Murray, Sam Philip

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.

Figures

Fig. 1
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
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
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
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
Fig. 4
Distribution of endocrinologists’ scores according to patients’ profiles (Step 2 pilot study; n = 26 patients)

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