Abstract

Context

The SAGIT ^® instrument (SAGIT) has been developed to enable accurate characterization of acromegaly disease activity.

Objective

Evaluate the ability of SAGIT to discriminate between acromegaly disease control status.

Design

Multicenter, non-interventional, prospective and retrospective, longitudinal study.

Settings and Patients

Academic and private clinical practice sites; patients aged ≥18 years with diagnosis of controlled (n=109) or non-controlled (n=105) acromegaly, assessed by clinical global evaluation of disease control (CGE-DC) questionnaire, investigator therapeutic decision and international guidelines. Control status was not determined at baseline for 13 patients. As a limited number of patients were enrolled retrospectively (N=9), all presented analyses are based on the prospective population (N=227).

Methods

Patients were assessed over a two-year follow-up period. Classification and regression tree (CART) analyses were performed to investigate how the SAGIT components at baseline (signs/symptoms [S], associated comorbidities [A], GH levels [G], IGF-1 levels [I], tumor features [T]) discriminate between controlled and non-controlled acromegaly.

Results

Baseline mean subscores S, G, I and T, were significantly lower in patients with CGE-DC controlled acromegaly compared with CGE-DC non-controlled acromegaly. SAGIT components I and G for CGE-DC and S, A, G, I and T for the clinician’s therapeutic decision were retained by CART analyses. For international guidelines, only SAGIT component I was retained. The risk for undergoing at least one treatment change during the study for patients with CGE-DC non-controlled acromegaly relative to CGEDC controlled acromegaly was 3.44 times greater.

Conclusion

The SAGIT instrument is a valid and sensitive tool to comprehensively and accurately assess acromegaly severity.

中文翻译：

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SAGIT ® 仪器治疗肢端肥大症的国际多中心验证研究

摘要

语境

SAGIT ^®仪器 (SAGIT) 已开发用于准确表征肢端肥大症疾病活动。

客观的

评估 SAGIT 区分肢端肥大症疾病控制状态的能力。

设计

多中心、非介入性、前瞻性和回顾性纵向研究。

设置和患者

学术和私人临床实践场所；年龄≥18 岁且诊断为受控 (n=109) 或未受控 (n=105) 肢端肥大症的患者，通过临床疾病控制全球评估 (CGE-DC) 问卷、研究者治疗决定和国际指南进行评估。13 名患者在基线时未确定控制状态。由于回顾性招募的患者数量有限（N=9），所有呈现的分析均基于前瞻性人群（N=227）。

方法

在两年的随访期内对患者进行了评估。进行分类和回归树 (CART) 分析以研究基线时的 SAGIT 成分（体征/症状 [S]、相关合并症 [A]、GH 水平 [G]、IGF-1 水平 [I]、肿瘤特征 [T] ]) 区分控制性和非控制性肢端肥大症。

结果

与 CGE-DC 未控制的肢端肥大症相比，CGE-DC 控制的肢端肥大症患者的基线平均子评分 S、G、I 和 T 显着较低。用于 CGE-DC 的 SAGIT 组件 I 和 G 以及用于临床医生治疗决策的 S、A、G、I 和 T 由 CART 分析保留。对于国际指南，仅保留了 SAGIT 组件 I。与 CGEDC 控制的肢端肥大症相比，CGE-DC 未控制的肢端肥大症患者在研究期间接受至少一种治疗改变的风险高 3.44 倍。

结论

SAGIT 仪器是一种有效且灵敏的工具，可以全面准确地评估肢端肥大症的严重程度。