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Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Editors: Priscilla Velentgas, PhD, Nancy A Dreyer, MPH, PhD, Parivash Nourjah, PhD, Scott R Smith, PhD, and Marion M Torchia, PhD.

Rockville (MD): Agency for Healthcare Research and Quality (US); .
Publication No.: 12(13)-EHC099

The Observational CER User's Guide serves as a resource for investigators and stakeholders when designing observational comparative effectiveness research (CER) studies, particularly those with findings that are intended to translate into decisions or actions. The User's Guide provides principles for designing research that will inform health care decisions of patients and other stakeholders. Furthermore, it serves as a reference for increasing the transparency of the methods used in a study and standardizing the review of protocols through checklists provided in every chapter.

Contents

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2005-0016-I and 290-2005-0035-I. Prepared by: Quintiles Outcome, Cambridge, MA

Suggested citation:

Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM, eds. Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide. AHRQ Publication No. 12(13)-EHC099. Rockville, MD: Agency for Healthcare Research and Quality; January 2013. www.effectivehealthcare.ahrq.gov/Methods-OCER.cfm.

The Agency for Healthcare Research and Quality’s (AHRQ) Effective Health Care Program conducts and supports research focused on the outcomes, effectiveness, comparative clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services. More information on the Effective Health Care Program and electronic copies of this report can be found at www.effectivehealthcare.ahrq.gov.

This report was produced under contract to AHRQ by the Brigham and Women's Hospital DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Methods Center and Quintiles Outcomes under Contract No. 290-2005-0016-I and 290-2005-0035-1. The AHRQ Task Order Officer for this project was Parivash Nourjah, Ph.D. The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ or the U.S. Department of Health and Human Services. Therefore, no statement in this report should be construed as an official position of AHRQ or the U.S. Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

1

540 Gaither Road, Rockville, MD 20850; www​.ahrq.gov

Copyright © 2013, Agency for Healthcare Research and Quality.

Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide is copyrighted by the Agency for Healthcare Research and Quality (AHRQ). The product and its contents may be used and incorporated into other materials on the following three conditions: (1) the contents are not changed in any way (including covers and front matter), (2) no fee is charged by the reproducer of the product or its contents for its use, and (3) the user obtains permission from the copyright holders identified therein for materials noted as copyrighted by others. The product may not be sold for profit or incorporated into any profitmaking venture without the expressed written permission of AHRQ.

Bookshelf ID: NBK126190PMID: 23469377

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