DT-1: Specify clinical context and key elements of the diagnostic test
A comparative evaluation of diagnostic tests should specify each of the following items and provide rationale in support of the particular choices:
- the intended use of the test and the corresponding clinical context, including referral for additional testing, referral for additional treatments, and modification of current treatment and target populations;
- the goal of the comparison;
- the technical specifications of the tests as implemented in the study;
- the approach to test interpretation;
- the sources and process for obtaining reference standard information, when applicable;
- the procedures for obtaining follow-up information and determining patient outcomes, when applicable; and
- the clinical pathways involving the tests and the anticipated implications of test use on downstream processes of care and patient outcomes.
These items ought to be specified for all designs, including observational designs (e.g., those using medical records or registries). If these items are not available directly, validated approaches to approximating these study elements from available data should be used.
Public comments
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10: Standards for Studies of Diagnostic Tests
DT-1: Specify clinical context and key elements of the diagnostic test
A comparative evaluation of diagnostic tests should specify each of the following items and provide rationale in support of the particular choices:
- the intended use of the test and the corresponding clinical context, including referral for additional testing, referral for additional treatments, and modification of current treatment and target populations;
- the goal of the comparison;
- the technical specifications of the tests as implemented in the study;
- the approach to test interpretation;
- the sources and process for obtaining reference standard information, when applicable;
- the procedures for obtaining follow-up information and determining patient outcomes, when applicable; and
- the clinical pathways involving the tests and the anticipated implications of test use on downstream processes of care and patient outcomes.
These items ought to be specified for all designs, including observational designs (e.g., those using medical records or registries). If these items are not available directly, validated approaches to approximating these study elements from available data should be used.Public comments