Strong |
Studies with broad generalizability to most patients suspected of having the disease; include prospective, blinded comparison of a diagnostic test with a well-defined final diagnosis in an unbiased sample when assessing diagnostic accuracy or blinded randomized control trials when assessing therapeutic impact or patient outcomes; also included are well-designed meta-analyses |
Moderate |
Prospective or retrospective studies with narrower spectrum of generalizability, with only a few flaws that are well-described so that their impact can be assessed but still include a blinded study of diagnostic accuracy on an unbiased sample (well-designed cohort or case-control studies) and randomized trials for therapeutic effects or patient outcomes |
Limited |
Diagnostic accuracy studies with several flaws in research methods, small sample sizes, incomplete reporting, or nonrandomized comparisons for therapeutic impact or patient outcomes |
Insufficient |
Studies with multiple flaws in research methods, case series, descriptive studies, or expert opinions without substantiating data |