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Methods for Comparative Evidence Reviews September 2005. Oregon Evidence-based Practice Center for the Drug Effectiveness Review Project Marian McDonagh, Pharm D, Project Director Mark Helfand, MD, MPH, EPC Director. Apply Systematic Review Methods to Comparative Questions
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Methods for Comparative Evidence ReviewsSeptember 2005 Oregon Evidence-based Practice Center for the Drug Effectiveness Review Project Marian McDonagh, Pharm D, Project Director Mark Helfand, MD, MPH, EPC Director
Apply Systematic Review Methods to Comparative Questions Drug vs Drug within class Ensure that reviews are: Methodologically Consistent Methodologically Transparent Reports are User Friendly Lowest risk of bias in methods and researchers Health Resources Commission Remit to Oregon Evidence-based Practice Center
Question 1:Effectiveness and/or Efficacy Health Outcomes preferred over intermediate outcomes Question 2: Harms and Tolerability Short-term adverse events Long-term safety Question 3: Sub-populations Age Race/ethnicity Gender Co-morbidities Inclusion Criteria based on key questions Key Question Development
Each study included in review is assessed for internal validity (quality) and external validity (generalizability / applicability) Quality rated using predefined criteria Good: meets all criteria Fair: meets most criteria Poor: “fatal flaw”, combinations of criteria are not met that indicate significant risk of bias Not used in analysis Quality Assessment
Study data abstracted into tables for cross-study comparison Qualitative synthesis of data Quantitative synthesis of data Meta-analysis when appropriate Overall grade allocated for the body of evidence for each key question Data Collection and Analysis
Reports written with user in mind Draft reports undergo: Peer Review Public Comment AHRQ review for methods Every report includes a summary table that provides summary of evidence by Key Question Every report has a slide show Researchers make presentations to committees Available for questions relating to the evidence (only) Reports
Every report is updated 6-month or yearly basis Determined by committees with input from researchers Update process starts with revisiting the Key Questions Modifications needed? New drugs? New populations/indications to consider? Update process identical to original review Updates
Oregon Evidence-based Practice Center Oregon Health & Science University 3181 SW Sam Jackson Park Road Portland, OR 97239 Drug Effectiveness Review Project www.ohsu.edu/drugeffectiveness