The Prime Diabetes Model: Novel Methods for Estimating Long-Term Clinical and Cost Outcomes in Type 1 Diabetes Mellitus.
|Abstract||Recent publications describing long-term follow-up from landmark trials and diabetes registries represent an opportunity to revisit modeling options in type 1 diabetes mellitus (T1DM).|
The CORE Diabetes Model: Projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making.
|Journal Title||value in health : the journal of the international society for pharmacoeconomics and outcomes research|
|Publication Year Start||2017-01-01|
PMID- 28712629 OWN - NLM STAT- MEDLINE DA - 20170717 DCOM- 20170724 LR - 20170724 IS - 1524-4733 (Electronic) IS - 1098-3015 (Linking) VI - 20 IP - 7 DP - 2017 Jul - Aug TI - The Prime Diabetes Model: Novel Methods for Estimating Long-Term Clinical and Cost Outcomes in Type 1 Diabetes Mellitus. PG - 985-991 LID - S1098-3015(16)30089-4 [pii] LID - 10.1016/j.jval.2016.12.001 [doi] AB - BACKGROUND: Recent publications describing long-term follow-up from landmark trials and diabetes registries represent an opportunity to revisit modeling options in type 1 diabetes mellitus (T1DM). OBJECTIVES: To develop a new product-independent model capable of predicting long-term clinical and cost outcomes. METHODS: After a systematic literature review to identify clinical trial and registry data, a model was developed (the PRIME Diabetes Model) to simulate T1DM progression and complication onset. The model runs as a patient-level simulation, making use of covariance matrices for cohort generation and risk factor progression, and simulating myocardial infarction, stroke, angina, heart failure, nephropathy, retinopathy, macular edema, neuropathy, amputation, hypoglycemia, ketoacidosis, mortality, and risk factor evolution. Several approaches novel to T1DM modeling were used, including patient characteristics and risk factor covariance, a glycated hemoglobin progression model derived from patient-level data, and model averaging approaches to evaluate complication risk. RESULTS: Validation analyses comparing modeled outcomes with published studies demonstrated that the PRIME Diabetes Model projects long-term patient outcomes consistent with those reported for a number of long-term studies. Macrovascular end points were reliably reproduced across five different populations and microvascular complication risk was accurately predicted on the basis of comparisons with landmark studies and published registry data. CONCLUSIONS: The PRIME Diabetes Model is product-independent, available online, and has been developed in line with good practice guidelines. Validation has indicated that outcomes from long-term studies can be reliably reproduced. The model offers new approaches to long-standing challenges in diabetes modeling and may become a valuable tool for informing health care policy. CI - Copyright (c) 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved. FAU - Valentine, William J AU - Valentine WJ AD - Ossian Health Economics and Communications, Basel, Switzerland. Electronic address: [email protected] FAU - Pollock, Richard F AU - Pollock RF AD - Ossian Health Economics and Communications, Basel, Switzerland. FAU - Saunders, Rhodri AU - Saunders R AD - Ossian Health Economics and Communications, Basel, Switzerland. FAU - Bae, Jay AU - Bae J AD - Eli Lilly and Company, Indianapolis, IN, USA. FAU - Norrbacka, Kirsi AU - Norrbacka K AD - Eli Lilly and Company, Helsinki, Finland. FAU - Boye, Kristina AU - Boye K AD - Eli Lilly and Company, Indianapolis, IN, USA. LA - eng PT - Journal Article PT - Validation Studies DEP - 20170504 PL - United States TA - Value Health JT - Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research JID - 100883818 SB - IM MH - Diabetes Mellitus, Type 1/economics/physiopathology/*therapy MH - Disease Progression MH - Female MH - Health Policy MH - Humans MH - Male MH - *Models, Economic MH - *Models, Theoretical MH - Outcome Assessment (Health Care)/*methods MH - Reproducibility of Results MH - Risk Factors MH - Time Factors OTO - NOTNLM OT - cost-effectiveness OT - model OT - risk prediction OT - type 1 diabetes mellitus EDAT- 2017/07/18 06:00 MHDA- 2017/07/25 06:00 CRDT- 2017/07/18 06:00 PHST- 2016/02/12 [received] PHST- 2016/12/01 [accepted] AID - S1098-3015(16)30089-4 [pii] AID - 10.1016/j.jval.2016.12.001 [doi] PST - ppublish SO - Value Health. 2017 Jul - Aug;20(7):985-991. doi: 10.1016/j.jval.2016.12.001. Epub 2017 May 4.