title: SAGIT®: clinician-reported outcome instrument for managing acromegaly in clinical practice--development and results from a pilot study.
abstract: OBJECTIVE
  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.affiliation: Chair of Endocrinology, University of Brescia, Brescia, Italy. a.giustina@libero.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Giustina
authors.affiliation: Aberdeen Royal Infirmary, Aberdeen, UK.
authors.forename: John S
authors.initials: JS
authors.lastname: Bevan
authors.affiliation: Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Marcello D
authors.initials: MD
authors.lastname: Bronstein
authors.affiliation: Department of Medicine, Santiago de Compostela University - CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto Salud Carlos III, Santiago de Compostela, Spain.
authors.forename: Felipe F
authors.initials: FF
authors.lastname: Casanueva
authors.affiliation: Hôpital Bicêtre, Kremlin-Bicêtre, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Chanson
authors.affiliation: ENDOC Centre for Endocrine Tumours, Hamburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Petersenn
authors.affiliation: Ipsen, Boulogne-Billancourt Cedex, France.
authors.forename: Xuan-Mai Truong
authors.initials: XM
authors.lastname: Thanh
authors.affiliation: Ipsen, Boulogne-Billancourt Cedex, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Sert
authors.affiliation: Ipsen, Boulogne-Billancourt Cedex, France.
authors.forename: Aude
authors.initials: A
authors.lastname: Houchard
authors.affiliation: Mapi, Lyon, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Guillemin
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Shlomo
authors.initials: S
authors.lastname: Melmed
mesh_terms: D000172:Acromegaly / Q000175:diagnosis*; D003955:Diagnostic Tests, Routine / Q000295:instrumentation*; D005260:Female; D006282:Health Personnel; D006801:Humans; D008297:Male; D010865:Pilot Projects
keywords: Acromegaly; Clinician-reported outcomes; Instrument; Pilot study