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Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Methods for Comparative Evidence Reviews September 2005 Oregon Evidence-based Practice Center for the Drug.

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Presentation on theme: "Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT Methods for Comparative Evidence Reviews September 2005 Oregon Evidence-based Practice Center for the Drug."— Presentation transcript:

1 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

2 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

3 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

4 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

5 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

6 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

7 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

8 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)

9 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

10 Oregon EPC DRUG EFFECTIVENESS REVIEW PROJECT 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


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