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document
Design of a cost-effectiveness study within a randomized trial : the LIPID Trial for Secondary Prevention of IHD . Long-term Intervention with Pravastatin in Ischemic Heart disease . The Long-term Intervention with Pravastatin in Ischemic Heart Disease ( LIPID ) trial is a double-blind , randomized , placebo-controlled trial evaluating the long-term effect of pravastatin on coronary mortality in patients with a previous myocardial infarction or unstable angina-ischemic heart disease ( IHD ) . It is planned to run for at least five years with 9014 patients from 85 centers in Australia and New Zealand . The trial will monitor cause-specific mortality and major clinical events associated with each treatment . Running in parallel with the main study is a prospective economic analysis , the objectives of which are ( 1 ) to estimate the effectiveness of pravastatin compared with placebo in terms of survival , quality of life ( QOL ) , and quality-adjusted life-years ( QALY ) ; ( 2 ) to estimate the resource usage associated with pravastatin compared with placebo-in particular , to study whether it alters resource usage through prevention of disease progression ; and ( 3 ) to use this information for a cost-utility analysis with cost per quality-adjusted life-year as the unit of analysis . A novel aspect of the design is the use of a preliminary cost-effectiveness analysis , based on " best-guess " values , and a sensitivity analysis over plausible ranges to guide the choice of subsample size . Some data , such a mortality , days spent in hospital , major clinical events , and drug use , are being collected within the main LIPID trial . However , additional subsamples for the cost-effectiveness study will include information on quality of life , time off work , and resources used , such as time in hospital , procedures , and medications taken . The methods and sample sizes for these substudies have been a crucial issue in validity and feasibility .
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Intervention_Pharmacological
Pravastatin
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Intervention_Pharmacological
Pravastatin
90487
Intervention_Control
placebo-controlled
90488
Intervention_Control
pravastatin
90489
Intervention_Pharmacological
pravastatin
90490
Intervention_Pharmacological
pravastatin
90491
Intervention_Control
placebo-in
90492
Outcome_Mortality
survival
90493
Outcome_Other
quality of life ( QOL )
90494
Outcome_Other
quality-adjusted life-years ( QALY )
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Outcome_Mortality
mortality
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Outcome_Other
days spent in hospital
90497
Outcome_Physical
major clinical events
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Outcome_Mental
drug use
90499
Outcome_Other
cost-effectiveness
90500
Outcome_Other
quality of life
90501
Outcome_Other
time off work
90502
Outcome_Other
resources used
90503
Outcome_Other
time in hospital
90504
Outcome_Other
procedures
90505
Outcome_Other
medications taken
90506
Participant_Condition
IHD .