Rapid ACCE: Experience with a rapid and structured approach for evaluating gene-based testing

Abstract

PURPOSE: To present the rapid-ACCE model and report our early experience of using the ACCE structure to guide systematic reviews for the rapid evaluation of emerging genetic tests. METHODS: A rapid-ACCE review uses the same 44 questions that were developed for the full-ACCE model to guide the conduct of systematic review. We combined published literature with unpublished data to estimate test performance and input from experts to help clarify qualitative issues. As questions were answered, gaps in knowledge were identified and articulated. The draft review was then sent to outside reviewers whose comments were incorporated into the final document. RESULTS: We conducted two reviews, both of which were completed in 6 months or less (averaging about 100 hours of primary analyst time), within modest budgets. In addition to defining the current state of knowledge about the tests, the identified gaps are expected to help define the research agendas. Both collaborating experts and study sponsors valued both the process and outcomes from the reviews. CONCLUSIONS: Based on our early experiences, it is possible to conduct rapid systematic reviews within the ACCE structure of some emerging genetic tests to produce summaries of available evidence and identification of gaps. ©2007The American College of Medical Genetics.