Estimation of Mortality Risk in Type 2 Diabetic Patients (ENFORCE): An Inexpensive and Parsimonious Prediction Model
- 14 May 2019
- journal article
- research article
- Published by The Endocrine Society in Journal of Clinical Endocrinology & Metabolism
- Vol. 104 (10), 4900-4908
- https://doi.org/10.1210/jc.2019-00215
Abstract
Context We previously developed and validated an inexpensive and parsimonious prediction model of 2-year all-cause mortality in real-life patients with type 2 diabetes. Objective This model, now named ENFORCE (EstimatioN oF mORtality risk in type 2 diabetiC patiEnts), was investigated in terms of (i) prediction performance at 6 years, a more clinically useful time-horizon; (ii) further validation in an independent sample; and (iii) performance comparison in a real-life vs a clinical trial setting. Design Observational prospective randomized clinical trial. Setting White patients with type 2 diabetes. Patients Gargano Mortality Study (GMS; n = 1019), Foggia Mortality Study (FMS; n = 1045), and Pisa Mortality Study (PMS; n = 972) as real-life samples and the standard glycemic arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) clinical trial (n = 3150). Main Outcome Measure The endpoint was all-cause mortality. Prediction accuracy and calibration were estimated to assess the model's performances. Results ENFORCE yielded 6-year mortality C-statistics of 0.79, 0.78, and 0.75 in GMS, FMS, and PMS, respectively (P heterogeneity = 0.71). Pooling the three cohorts showed a 6-year mortality C-statistic of 0.80. In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value significantly lower than that obtained in the pooled real-life samples (P < 0.0001). This difference resembles that observed with other models comparing real-life vs clinical trial settings, thus suggesting it is a true, replicable phenomenon. Conclusions The time horizon of ENFORCE has been extended to 6 years and validated in three independent samples. ENFORCE is a free and user-friendly risk calculator of all-cause mortality in white patients with type 2 diabetes from a real-life setting.Keywords
Funding Information
- Ministero della Salute (RC2016, RC2017, RF-2013-02356459)
- Ministero dell’Istruzione, dell’Università e della Ricerca (PRIN2012 grant 31)
- National Heart, Lung, and Blood Institute (N01-HC-95178, N01-HC-95179, N01-HC-95180, N01-HC-95181, N01-HC-95182, N01-HC-95183, N01-HC-95184, IAA-Y1-HC-9035, IAA-Y1-HC-1010)
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