One of the commonly used systems for grading the evidence is:
A. Ia: systematic review or meta-analysis of RCTs; Ib: at least one RCT
B. IIa: at least one well-designed controlled study without randomization; IIb: at least one well-designed quasi-experimental study, such as a cohort study
C. III: well-designed non-experimental descriptive studies (comparative studies, correlation studies, case-control studies, case series, case reports)
D. IV: expert committee reports, opinions formal consensus
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The levels of recommendation are based on the strength of evidence:
A: based on hierarchy I evidence
B: based on hierarchy II evidence or extrapolated from hierarchy I evidence
C: based on hierarchy II evidence or extrapolated from hierarchy I or II evidence
D: directly based on hierarchy IV evidence or extrapolated from hierarchy I, II, or III evidence
Usethefollowingfourquestionstodeterminethedifferencebetweenaclinicalstudyandaclinicaltrial (if the answers to the following 4 questions are yes, your study meets the NIH definition of a clinical trial):
A. Doesthestudyinvolvehumanparticipants?
B. Aretheparticipantsprospectivelyassignedtoanintervention?
C. Isthestudydesignedtoevaluatetheeffectoftheinterventionontheparticipants?
D. Istheeffectbeingevaluatedahealth-relatedbiomedicalorbehavioraloutcome?
Phase 1 studies are designed to:
A. evaluate the pharmacokinetics and pharmacodynamics of new treatments
B. evaluate the risks of the treatment
C. evaluate how the drug influences the human body andhow the human body influences the drug
D. identify an appropriate dose to be used in subsequent phase 2 studies
Analysis of the ethics of clinical research requires evaluation of three related risk-benefit profiles:
A. the risk-benefit profile of the interventions(s) under study
B. the risk-benefit profile of the included research procedures
C. the risk-benefit profile of the study as a whole
D. the risk-benefit profile of the investigator
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