ApplyingTrialsandSystematicReviewstoIndividualPat.pptVIP

Applying Trials and Systematic Reviews to Individual Patients Paul Glasziou Centre for Evidence Based Medicine University of Oxford Overview Why is applicability a problem? What are the issues? How can we improve? The “5-step” process Check on the transferability Application to an individual The problem: The “Leaks” between research practice Variation in Guidelines: % of AF patients “needing” warfarin Should Mr RM buy an electric toothbrush? 72 year old pensioner with Parkinson’s Disease Has gingivitis and frequent caries Trials in young healthy folk showing improvements in gingivitis scores but not caries. Would the electric brush “work” for him? What should he do? What did you think? Osteoarthritis N-of-1s Comparison of 1,000mg paracetamol tds 400mg ibuprofen tds Two weeks x 6 Outcome diary of pain and stiffness of target joint N-of-1: overall examples Interventions: Levels of Evidence N-of-1 Trial Systematic review of randomised trials A single randomised trial Controlled, non-randomised Parallel control Historical control Case-control Case-series When n-of-1 not possible:The benefit-harm model (Lubsen, Tijssen*) When does benefit outweigh harm? Assumptions Benefit (rate difference) proportional to event rate Harm constant over event rate Net benefit = benefit - harm Transferability and applicability of results TRANSFERABILITY (across groups) What are the benefits and harms? Is there predictable variation in the effects? How does effect vary with predicted risk? APPLICATION (to individual) What are the predicted absolute risk reductions for individuals? Do the benefits outweigh the harms? Questions so far? 1. What are the benefits and harms? List all important outcomes beneficial and harmful Get best estimate (from meta-analysis) Summarise in a “clinical balance sheet” Antibiotics for Acute Otitis Media For Pain(at 2-7 days)RRR = 28% Clinical Balance Sheet All or some responders? 2. Are there predictable variations in the effects? Does effect var