Estimation of Mortality Risk in Type 2 Diabetic Patients (ENFORCE): An Inexpensive and Parsimonious Prediction Model

Massimiliano Copetti, Hetal Shah, Andrea Fontana, Maria Giovanna Scarale, Claudia Menzaghi, Salvatore De Cosmo, Monia Garofolo, Maria Rosaria Sorrentino, Olga Lamacchia, Giuseppe Penno, Alessandro Doria, Vincenzo Trischitta

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)4900-4908
Number of pages9
JournalThe Journal of clinical endocrinology and metabolism
Volume104
Issue number10
DOIs
Publication statusPublished - Oct 1 2019

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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