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When To Select Observational Studies as Evidence for Comparative Effectiveness Reviews Prepared for: The Agency for Healthcare Research and Quality (AHRQ) Training Modules for Systematic Reviews Methods Guide www.ahrq.gov
Systematic Review Process Overview
[object Object],[object Object],[object Object],Learning Objectives
[object Object],[object Object],Current Perspective
[object Object],Comparative Effectiveness Reviews
[object Object],[object Object],[object Object],[object Object],[object Object],Danger of Overreliance on Randomized Controlled Trials
[object Object],[object Object],[object Object],[object Object],Observational Studies
[object Object],[object Object],[object Object],Using Observational Studies To Assess Benefits (I)
Using Observational Studies To Assess Benefits (II) OS = observational study; PICOTS = population, intervention, comparator, outcome, timing, and setting. Consider OSs Always consider: Controlled trials Will OSs provide valid and useful information? Assess whether OSs address the review question  Are there gaps in trial evidence? Systematic review question   ( including PICOTS) Yes Refocus the review  question on gaps Assess the suitability of OSs:   Natural history of the disease  or exposure Potential biases Confine review to  controlled trials No
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Gaps in Trial Evidence: PICOTS
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Are Trial Data Sufficient? (I)
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Are Trial Data Sufficient? (II)
[object Object],[object Object],[object Object],[object Object],[object Object],When To Identify Gaps in Trial Evidence
Iterative Process for Identifying Gaps in Evidence ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Extract Data from Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Report Systematic Review
[object Object],[object Object],Gaps in Trial Evidence
Using Observational Studies To Assess Benefits OS = observational study; PICOTS = population, intervention, comparator, outcome, timing, and setting. Systematic review question   ( including PICOTS) OS = observational study; PICOTS = population, intervention, comparator,  outcome, timing, and setting Consider OSs Always consider: Controlled trials Will OSs provide valid and useful information? Assess whether OSs address the review question  Are there gaps in trial evidence? Yes Refocus the review  question on gaps Assess the suitability of OSs:   Natural history of the disease  or exposure Potential biases Confine review to  controlled trials No
[object Object],[object Object],[object Object],[object Object],Will Observational Studies Provide Valid and Useful Information?
[object Object],[object Object],[object Object],Assessing the Suitability of Observational Studies To Answer the Review Questions
[object Object],[object Object],[object Object],Clinical Context
[object Object],[object Object],[object Object],[object Object],Potential Biases That May Limit the Suitability of Including Observational Studies
[object Object],[object Object],[object Object],[object Object],Confounding by Indication
[object Object],[object Object],[object Object],Using Observational Studies To Assess Benefits
[object Object],[object Object],[object Object],[object Object],Harms Assessments
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Using Randomized Controlled Trials To Assess Harms (I)
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Using Randomized Controlled Trials To Assess Harms (II)
[object Object],[object Object],[object Object],[object Object],Using Randomized Controlled Trials To Assess Harms (III)
[object Object],[object Object],[object Object],[object Object],Using Data From Unpublished Trials To Assess Harms
[object Object],[object Object],[object Object],[object Object],[object Object],Using Observational Studies To Assess Harms
[object Object],[object Object],[object Object],Hypothesis Testing Versus Hypothesis Generating Chou R, et al.  J Clin Epidemiol  2010;63:502-12.
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Types of Observational Studies That Can Be Used To Assess Harms
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Screening Observational Studies for Inclusion in Harms Assessments
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Key Messages
[object Object],[object Object],References
[object Object],[object Object],Authors

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When to Select Observational Studies as Evidence for Comparative Effectiveness Reviews

  • 1. When To Select Observational Studies as Evidence for Comparative Effectiveness Reviews Prepared for: The Agency for Healthcare Research and Quality (AHRQ) Training Modules for Systematic Reviews Methods Guide www.ahrq.gov
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  • 9. Using Observational Studies To Assess Benefits (II) OS = observational study; PICOTS = population, intervention, comparator, outcome, timing, and setting. Consider OSs Always consider: Controlled trials Will OSs provide valid and useful information? Assess whether OSs address the review question Are there gaps in trial evidence? Systematic review question ( including PICOTS) Yes Refocus the review question on gaps Assess the suitability of OSs: Natural history of the disease or exposure Potential biases Confine review to controlled trials No
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  • 16. Using Observational Studies To Assess Benefits OS = observational study; PICOTS = population, intervention, comparator, outcome, timing, and setting. Systematic review question ( including PICOTS) OS = observational study; PICOTS = population, intervention, comparator, outcome, timing, and setting Consider OSs Always consider: Controlled trials Will OSs provide valid and useful information? Assess whether OSs address the review question Are there gaps in trial evidence? Yes Refocus the review question on gaps Assess the suitability of OSs: Natural history of the disease or exposure Potential biases Confine review to controlled trials No
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