GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health

Objective: To describe the Grading of Recommendations Assessment, Development and Evaluation (GRADE) interactive Evidence to Decision (EtD) frameworks for tests and test strategies for clinical, public health or coverage decisions. Study Design and Setting: As part of the GRADE Working Group's DECIDE project we conducted workshops, user testing with systematic review authors, guideline developers and other decision makers, and piloted versions of the EtD framework. Results: EtD frameworks for tests share the structure, explicitness, and transparency of other EtD frameworks. They require specifying the purpose of the test, linked or related management and the key outcomes of concern for different test results and subsequent management. The EtD criteria address test accuracy and assessments of the certainty of the additional evidence necessary for decision-making. When there is no direct evidence of test effects on patient important outcomes, formal or informal modeling is needed to estimate effects. We describe the EtD criteria based on examples developed with GRADEpro (www.gradepro.org), GRADE's software that also provides interactive Summary of Findings Tables. Conclusion: EtD frameworks for developing recommendations and making decisions about tests lay out the sequential steps in reviewing and assessing the different types of evidence that need to be linked.