Economic Evaluation of Factorial Trials: Cost-Utility Analysis of the Atorvastatin in Factorial With Omega EE90 Risk Reduction in Diabetes 2 × 2 × 2 Factorial Trial of Atorvastatin, Omega-3 Fish Oil, and Action Planning

Autor: Helen Dakin, Andrew Farmer, Alastair Gray, Rury R. Holman
Rok vydání: 2020
Předmět:
Adult
Male
medicine.medical_specialty
Factorial
Cost-Benefit Analysis
United Kingdom Prospective Diabetes Study
Atorvastatin
Psychological intervention
Drug Costs
law.invention
lipids
03 medical and health sciences
Fish Oils
0302 clinical medicine
Randomized controlled trial
law
Fatty Acids
Omega-3
medicine
Humans
adherence
030212 general & internal medicine
Cost–utility analysis
business.industry
030503 health policy & services
Health Policy
Public Health
Environmental and Occupational Health
Health Care Costs
Factorial experiment
Diabetes Mellitus
Type 2
factorial design
individual patient simulation model
randomized controlled trial
Economic evaluation
Physical therapy
Female
type 2 diabetes
Quality-Adjusted Life Years
Economic Evaluation
0305 other medical science
business
Risk Reduction Behavior
medicine.drug
Zdroj: Value in Health
ISSN: 1098-3015
Popis: Objectives We applied principles for conducting economic evaluations of factorial trials to a trial-based economic evaluation of a cluster-randomized 2 × 2 × 2 factorial trial. We assessed the cost-effectiveness of atorvastatin, omega-3 fish oil, and an action-planning leaflet, alone and in combination, from a UK National Health Service perspective. Methods The Atorvastatin in Factorial With Omega EE90 Risk Reduction in Diabetes (AFORRD) Trial randomized 800 patients with type 2 diabetes to atorvastatin, omega-3, or their respective placebos and randomized general practices to receive a leaflet-based action-planning intervention designed to improve compliance or standard care. The trial was conducted at 59 UK general practices. Sixteen-week outcomes for each trial participant were extrapolated for 70 years using the United Kingdom Prospective Diabetes Study Outcomes Model v2.01. We analyzed the trial as a 2 × 2 factorial trial (ignoring interactions between action-planning leaflet and medication), as a 2 × 2 × 2 factorial trial (considering all interactions), and ignoring all interactions. Results We observed several qualitative interactions for costs and quality-adjusted life-years (QALYs) that changed treatment rankings. However, different approaches to analyzing the factorial design did not change the conclusions. There was a ≥99% chance that atorvastatin is cost-effective and omega-3 is not, at a £20 000/QALY threshold. Conclusions Atorvastatin monotherapy was the most cost-effective combination of the 3 trial interventions at a £20 000/QALY threshold. Omega-3 fish oil was not cost-effective, while there was insufficient evidence to draw firm conclusions about action planning. Recently-developed methods for analyzing factorial trials and combining parameter and sampling uncertainty were extended to estimate cost-effectiveness acceptability curves within a 2x2x2 factorial design with model-based extrapolation.
Highlights • Methods have been developed for conducting economic evaluations on 2 × 2 factorial trials, but the impact of more complex designs and studies with model-based extrapolation has not yet been explored. • Atorvastatin has been shown to be cost-effective for patients with type 2 diabetes, whereas omega-3 is not recommended. • We are not aware of any previous studies exploring interactions between statins, omega-3, and interventions to improve compliance in type 2 diabetes. • We applied methods for analyzing factorial trials to a trial with a 2 × 2 × 2 design and a model-based extrapolation. • We observed large interactions between the 3 interventions, although the methods for analyzing the factorial trial did not change the conclusions about which treatment was the best value for the money. • We extended recent work on combining sampling uncertainty and parameter uncertainty to estimate cost-effectiveness acceptability curves and the value of perfect information. • We confirmed that atorvastatin is cost-effective, but omega-3 is not. • Further research on action-planning interventions to improve compliance is likely to be good value for money.
Databáze: OpenAIRE
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