Temporal Validation of the UKPDS Outcomes Model Using 10-Year Posttrial Monitoring Data

Abstract

OBJECTIVE To evaluate the accuracy of the UK Prospective Diabetes Study Outcomes Model (UKPDS-OM) in predicting clinical outcomes during the UKPDS posttrial monitoring (PTM) period. RESEARCH DESIGN AND METHODS At trial end in 1997, the 4,031 surviving UKPDS patients, of the 5,102 originally enrolled in the study, returned to their usual care providers, with no attempts made to maintain them in their randomized therapy groups. PTM risk factor data were collected for 5 years and clinical outcome data for 10 years. The UKPDS-OM was used firstly to forecast likely progression of HbA_1c, systolic blood pressure, total-to-HDL cholesterol ratio, and smoking status and secondly to estimate the likely first occurrence of seven major diabetes-related complications or death from any cause. Model predictions were compared against observed PTM data for risk factor time paths and survival probabilities for major diabetes complications. RESULTS UKPDS-OM–forecasted risk factor time paths were similar to those observed for HbA_1c (up to 3 years) and total-to-HDL cholesterol ratio but underestimated for systolic blood pressure and smoking status. Predicted 10-year event probabilities were similar to those observed for blindness, ischemic heart disease, myocardial infarction, and renal failure but were higher for heart failure and death from any cause and lower for stroke and amputation. CONCLUSIONS The UKPDS-OM has good predictive accuracy for two of four risk factor time paths and for 10-year clinical outcome probabilities with the exception of stroke, amputation, heart failure, and death from any cause. An updated version of the model incorporating PTM data is being developed.