Format

Send to

Choose Destination
Pituitary. 2016 Feb;19(1):39-49. doi: 10.1007/s11102-015-0681-2.

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

Author information

1
Chair of Endocrinology, University of Brescia, Brescia, Italy. a.giustina@libero.it.
2
Aberdeen Royal Infirmary, Aberdeen, UK.
3
Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.
4
Department of Medicine, Santiago de Compostela University - CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto Salud Carlos III, Santiago de Compostela, Spain.
5
Hôpital Bicêtre, Kremlin-Bicêtre, France.
6
ENDOC Centre for Endocrine Tumours, Hamburg, Germany.
7
Ipsen, Boulogne-Billancourt Cedex, France.
8
Mapi, Lyon, France.
9
Cedars-Sinai Medical Center, Los Angeles, CA, USA.

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

PMID:
26377024
PMCID:
PMC4710645
DOI:
10.1007/s11102-015-0681-2
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Springer Icon for PubMed Central
Loading ...
Support Center