- Was the research question clearly stated?
1.1 Was the specific intervention(s) or procedure (independent variable(s)) identified?
1.2 Was the outcome(s) (dependent variable(s)) clearly indicated?
1.3 Were the target population and setting specified? Yes No Unclear N/A - Was the selection of study subjects/patients free from bias?
2.1 Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?
2.2 Were criteria applied equally to all study groups?
2.3 Were health, demographics, and other characteristics of subjects described?
2.4 Were the subjects/patients a representative sample of the relevant population? Yes No Unclear N/A - Were study groups comparable?
3.1 Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)
3.2 Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?
3.3 Were concurrent controls used? (Concurrent preferred over historical controls.)
3.4 If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?
3.5 If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable. Criterion may not be applicable in some cross-sectional studies.)
3.6 If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., “gold standard”)? Yes No Unclear N/A - Was method of handling withdrawals described?
4.1 Were follow up methods described and the same for all groups?
4.2 Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)
4.3 Were all enrolled subjects/patients (in the original sample) accounted for?
4.4 Were reasons for withdrawals similar across groups?
4.5 If diagnostic test, was decision to perform reference test not dependent on results of test under study? Yes No Unclear N/A
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