Structured Abstract

Contents

• Preface
• Acknowledgments
• Key Informants
• Technical Expert Panel
• Peer Reviewers
• Executive Summary
• Introduction
  • Background
  • Key Questions
  • Analytic Frameworks
  • Scope of the Review
• Methods
  • Topic Development and Refinement
  • Literature Search Strategy
  • Data Extraction and Management
  • Data Elements
  • Evidence Tables
  • Individual Study Quality Assessment
  • Measuring Outcomes of Interest
  • Data Synthesis
  • Grading the Body of Evidence
  • Assessment of Applicability
  • Peer Review and Public Commentary
• Results
  • Literature Search
  • Potential Biases in Included Studies
  • Analyses Relating to KQs 1 and 2
• Discussion
  • KQ 1 and KQ 2: Findings and Strength of Evidence
  • Potential To Combine Studies Addressing KQs 1 and 2
  • KQ 3: Findings and Strength of Evidence
  • Findings in Relationship to What Is Already Known
  • Applicability
  • Implications for Clinical and Policy Decisionmaking
  • Limitations of the Comparative Effectiveness Review Process
  • Limitations of the Evidence Base
  • Research Gaps
• References
• Abbreviations and Acronyms
• Appendix A Search Strategies for PCA3 Testing for the Diagnosis and Management of Prostate Cancer
• Appendix B Data Elements
• Appendix C Search Strategy for Grey Literature
• Appendix D Articles Excluded at Full-Text Level
• Appendix E Quality Assessment Criteria and Category Definitions for Nonrandomized Comparative Intervention Studies,
• Appendix F Quality Assessment of Studies Addressing KQ 1/KQ 2 and KQ 3
• Appendix G DistillerSR Abstract and Title Screening Form
• Appendix H DistillerSR Full-Text Article Screening Form
• Appendix I DistillerSR Data Extraction Forms
• Appendix J Detailed Description of PCA3 and Total PSA Interpretive Analysis
• Appendix K Summary of the Remaining Combined Analyses for KQ 1 and KQ 2

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services¹, Contract No. 290-2007-10058-I Prepared by: Blue Cross and Blue Shield Association Technology Evaluation Center, Evidence-based Practice Center, Chicago, IL

Suggested citation:

Bradley LA, Palomaki G, Gutman S, Samson DJ, Aronson N. PCA3 Testing for the Diagnosis and Management of Prostate Cancer. Comparative Effectiveness Review No. 98. (Prepared by the Blue Cross and Blue Shield Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-2007-10058-I). AHRQ Publication No. 13-EHC030-EF. Rockville, MD: Agency for Healthcare Research and Quality; April 2013. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

This report is based on research conducted by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10058-I). 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. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

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

1

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