Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT 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

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Health Resources Commission Remit to Oregon Evidence-based Practice Center 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

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Key Question Development 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

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Search for Literature Search electronic databases of published literature: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO Pharmaceutical company submissions Reference lists Experts

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Application of Inclusion Criteria Assessment of studies based on key questions –Populations / Indications –Interventions (drugs) –Outcome measures –Study designs Dual Assessment reduces risk, increases reliability

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Quality Assessment 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

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Data Collection and Analysis 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

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Reports 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)

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Updates 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

Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Oregon Evidence-based Practice Center Oregon Health & Science University 3181 SW Sam Jackson Park Road Portland, OR Drug Effectiveness Review Project