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Definitions of Study Quality Categories
Study Quality Category
Study Quality Definition
Criteria for Diagnostic Studies
Criteria for Therapeutic Studies
The study is well-designed and accounts for common biases.
The source has all 8 diagnostic study quality elements present.
The source has 5 or 6 therapeutic study quality elements
The study is moderately well-designed and accounts for most common biases.
The source has 6 or 7 diagnostic study quality elements
The source has 3 or 4 therapeutic study quality elements
There are important study design limitations.
The source has 3, 4, or 5 diagnostic study quality elements
The source has 1 or 2 therapeutic study quality elements
The study is not useful as primary evidence. The article may not be a clinical study or the study design is invalid, or conclusions are based on expert consensus. For example:
The study does not meet the criteria for or is not a hypothesis-based clinical study (e.g., a book chapter or case report or case series description);
The study may synthesize and draw conclusions about several studies such as a literature review article or book chapter but is not primary evidence;
The study is an expert opinion or consensus document.
The source has 0, 1, or 2 diagnostic study quality elements present.
The source has zero (0) therapeutic study quality elements.
Good quality – the study design, methods, analysis, and results are valid and the conclusion is supported.
Inadequate quality – the study design, analysis, and results lack the methodological rigor to be considered a good meta-analysis study.
© 2019. American College of Radiology.
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