Etiology | Content pertains directly to determining if there is an association between an exposure and a disease or condition | i. Observations concerned with the relationship between exposures and putative clinical outcomes; |
| | ii. Data collection is prospective; |
| | iii. Clearly identified comparison group(s); |
| | iv. Blinding of observers of outcome to exposure. |
Prognosis | Content pertains directly to the prediction of the clinical course or natural history of a disease or condition | i. Inception cohort initially free of the outcome of interest; |
| | ii. Follow-up of 80% or more patients until the occurrence of a major study end point or to the end of the study; |
| | iii. Analysis consistent with study design. |
Diagnosis | Content pertains directly to using a tool to arrive at a diagnosis of a disease or condition | i. Inclusion of a spectrum of participants; |
| | ii. Objective diagnostic (“gold”) standard or current clinical standard for diagnosis; |
| | iii. Participants received both the new test and some form of the diagnostic standard; |
| | iv. Interpretation of diagnostic standard without knowledge of test result and visa versa; |
| | v. Analysis consistent with study design. |
Treatment | Content pertains directly to an intervention for therapy (including adverse effects studies), prevention, rehabilitation, quality improvement or continuing medical education. | i. Random allocation of participants to comparison groups; |
| | ii. Outcome assessment of at least 80% of those entering the investigation accounted for in one major analysis at any given follow-up assessment; |
| | iii. Analysis consistent with study design. |
Economics | Content pertains directly to the economics of a health care issue. | i. The research question is a comparison of alternatives; |
| | ii. Alternative services or activities compared on outcomes produced (effectiveness) and resources consumed (costs); |
| | iii. Evidence of effectiveness must be from a study of real patients that meets the above-noted criteria for diagnosis, treatment, quality improvement, or a systematic review article; |
| | iv. Effectiveness and cost estimates based on individual patient data (micro-economics); |
| | v. Results presented in terms of the incremental or additional costs and outcomes of one intervention over another; |
| | vi. Sensitivity analysis if there is uncertainty. |
Clinical prediction guide | Content pertains directly to the prediction of some aspect of a disease or condition. | i. Guide is generated in one or more sets of real patients (training set); |
| | ii. Guide is validated in another set of real patients (test set). |
Review articles | Any full text bannered “review, overview, or meta-analysis” in the title or section heading, or indicated in the test that the intention was to review, summarize or highlight the literature on a particular topic | i. Statement of the clinical topic; |
| | ii. Explicit statement of the inclusion and exclusion criteria; |
| | iii. Description of the methods; |
| | iv. One or more article in the review must meet the above-noted criteria. |
Qualitative | Content relates to how people feel or experience certain situations. | Excluded from methodological rigor assessment |
Other | Content of the study does not fit into any of the other definitions | Excluded from methodological rigor assessment |