Structured Abstract

Contents

• Acknowledgments
• Executive Summary
• Introduction
  • Background and Objectives for the Systematic Review
  • Key Questions and Population, Intervention, Comparator, Outcome, Timing, and Setting (PICOTS)
  • PICOTS
• Methods
  • Literature Search Strategies
  • Study Eligibility Criteria
  • Data Management
  • Data Abstraction
  • Quality Assessment
  • Data Synthesis
• Results
  • Study Identification and Characteristics
  • Key Question 1 What genetic or molecular tissue of origin (TOO) tests are available for clinical use in the United States and what are their characteristics?
  • Key Question 2 What is the evidence on the analytic validity of the TOO tests?
  • Key Question 3a What is the evidence on the accuracy of the TOO test in classifying the origin and type of the tumor? Did the statistical methods adhere to the guidelines published by Simon et al. (2003)?
  • Key Question 3b What is the evidence on the accuracy of the TOO test in classifying the origin and type of the tumor?
  • Key Question 4 How successful are TOO tests in identifying the TOO in CUP patients?
  • Key Question 4a What is the evidence that genetic TOO tests change treatment decisions?
  • Key Question 4b What is the evidence that genetic TOO tests change outcomes?
  • Key Question 5 Is the TOO test relevant to the Medicare population?
• Discussion
  • Summary of Evidence
  • Key Question 1 TOO Tests
  • Key Question 2 Analytic Validity
  • Key Question 3a Statistical Validity
  • Key Question 3b Accuracy of the TOO Test in Classifying the Origin and Tissue of the Tumor
  • Key Question 4 Diagnosis
  • Key Question 4a Treatment
  • Key Question 4b Outcomes
  • Key Question 5 Applicability
• References
• Appendix A Inclusion and Exclusion Criteria
• Appendix B Search Strategies
• Appendix C Evidence Tables
• Appendix D Quality Assessment Ratings of Studies
• Appendix E Excluded Articles
• Appendix F Strength of Evidence Assessment Table
• Appendix G Genetic Testing in the Diagnosis of Ewing Sarcoma

This report is based on research conducted by the RTI Inernational-University of North Carolina at Chapel Hill (RTI-UNC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (HHSA290200710056I #8). 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 the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.

The information in this report is intended to help with health care decision-makers; patients and clinicians, health system leaders and policy makers, make well-informed decisions and thereby improve the quality of health care services. This report is not intended to substitute for the application of clinical judgement. Decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjuction 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 has any affiliations or financial involvement related to the material presented in this report.