PRELIMINARY TESTING OF THE SAGIT TOOL- A TOOL TO HELP ENDOCRINOLOGISTS IN THEIR MANAGEMENT OF PATIENTS WITH ACROMEGALY IN CLINICAL PRACTICE

Author(s)

Giustina A1;Bevan J2;Bronstein M3;Casanueva F4;Chanson P5;Petersenn S6;Truong Thanh XM7;Massien C7;Dias Barbosa C8;Guillemin I8;Arnould B*8, Melmed S9 1Piazzale Spedali Civili, Brescia, Italy, 2Aberdeen Royal Infirmary, Aberdeen, United Kingdom, 3Hospital das Clinicas, Sao Paulo, Brazil, 4Universidad de Santiago de Compostela, Santiago de Compostela, Spain, 5Hôpital Bicêtre, Kremlin-Bicêtre, France, 6ENDOC Center for Endocrine Tumors, Hamburg, Germany, 7Ipsen Pharma, Boulogne Billancourt Cedex, France, 8Mapi, Lyon, France, 9Cedars Sinai Medical Center, Los Angeles, CA, USA

OBJECTIVES: Acromegaly is a rare, chronic, hormonal disorder caused by excessive growth hormone (GH) and insulin-like growth factor 1 (IGF-1) production resulting predominantly from pituitary adenoma. The objective was to test endocrinologist acceptability of the newly developed SAGIT tool in clinical practice. METHODS: SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level – IGF-1 – Tumour) is a Clinician-Reported Outcomes (ClinROs) tool developed with international experts in acromegaly; it allows patient classification and description in a standardised manner. The tool was pre-tested for acceptability, understanding and ease of use with practicing endocrinologists in France, Germany, United Kingdom, Spain, Italy and Brazil (n=2 per country) using the PRAgmatic Content and face validity Test (PRAC-Test). The endocrinologists completed the SAGIT tool prior to and following an intervention (therapeutics or surgery) for three patients each (n=36). Once completed, a one-hour phone interview was conducted with each endocrinologist to collect their feedback on the tool. RESULTS: The tool was well accepted and deemed concise (n=11) and informative (n=10) by the endocrinologists. Several points were raised that illustrate its usefulness in clinical practice, including the removal of the subjectivity when assessing the disease severity, the possibility of rapid evaluation of the control/progression of acromegaly or of a treatment response, and the possibility for standardisation across countries. Key recommendations for improvements were the need to include: 1) instructions to facilitate the understanding and the use of the tool; 2) definitions of rules and recommendations for patient management; and 3) addition of other signs and symptoms and further details about tumour size to better reflect their clinical cases. CONCLUSIONS: SAGIT is a useful tool for endocrinologists to accurately stage and classify acromegaly patients in clinical practice. It is currently being piloted in a cross-sectional study. Validation of scoring rules will confirm the utility of the tool to improve patient management.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PDB92

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Diabetes/Endocrine/Metabolic Disorders

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