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

Abstract

PurposeThe 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).MethodsFor 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.ResultsThe 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.ConclusionsThe 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.Electronic supplementary materialThe online version of this article (doi:10.1007/s11102-015-0681-2) contains supplementary material, which is available to authorized users.

A Consensus Statement on acromegaly therapeutic outcomes

“…When GH and/or IGF1 levels are controlled, regular 6-month follow-up is prudent. Clinician-reported outcome instruments such as SAGIT (Signs and symptoms, Associated comorbidities, GH levels, IGF1 levels and Tumour profile) and ACRODAT (Acromegaly Disease Activity Tool) provide objective measurements of acromegaly signs and symptoms, comorbidities, tumour profile, GH levels and IGF1 levels (VLQ), and we recommend that they can be used to assess and monitor indicators of disease activity 52,53 (DR). Patient-reported health-related quality of life should also be considered.…”

Diagnostics and treatment of acromegaly — updated recommendations of the Polish Society of Endocrinology

“…Detailed propositions for the monitoring of acromegaly complications are presented in Table III [1]. In patient monitoring, in addition to normalisation of hormone levels, increasing importance is attached to the assessment of the quality of life (AcroQoL questionnaire) [43] and the disease course on the basis of two questionnaires: SAGIT (Signs and symptoms, Associated co-morbidities, GH levels, IGF-1 levels, Tumour profile) [44] and ACRODAT (Acromegaly Disease Activity Tool) [45].…”

“…W monitorowaniu pacjentów coraz większe znaczenie, poza wyrównaniem hormonalnym, przypisuje się ocenie jakości życia (kwestionariusz AcroQoL) [43], ocenie przebiegu choroby na podstawie kwestionariuszy SAGIT (Signs and symptoms, Associated comorbidities, GH levels, IGF-1 levels, Tumour profile) [44] i ACRODAT (Acromegaly Disease Activity Tool) [45].…”

Treatment of acromegaly patients at the Federal University of Triângulo Mineiro (UFTM): Experience Report

“…In addition, multidisciplinary care of patients with chronic complications and the systematic search for data in pre-defined protocols 32 will improve the quality of life and reduce the cardiometabolic risk factors and mortality of patients with acromegaly.…”