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level: Level 6

Questions and Answers List

level questions: Level 6

Question	Answer
(Different Study Designs for Different Questions) 1 Prevalence of a disease/disorder/trait? 2 Identification of risk factors for a disease/disorder/adverse event?	. 1 Random sample survey of relevant population 2 Case control study (for rare outcome) or cohort study (for more common outcome)
(Different Study Designs for Different Questions) 1 Prognosis? 2 Accuracy and reliability of a diagnostic test?	. 1 Patient cohort studies with follow-up at uniform points in clinical course of disease/disorder 2 Cross-over study of index test (new test) vs. Reference method (“gold standard”) in cohort of patients at risk of having disease/disorder
(Different Study Designs for Different Questions) 1 Accuracy and reliability of a screening test?	. 1 Crossover study of index test vs. reference method (“gold standard”) in representative cross-section of asymptomatic population at-risk for trait/disorder/preclinical disease
(Different Study Designs for Different Questions) 1 Efficacy/effectiveness (for health outcomes) of screening or diagnostic tests?	. 1 RCT if time and resources allow; observational studies and RCTs rigorously linked for analytic validity, clinical validity, and clinical utility
(Different Study Designs for Different Questions) 1Efficacy/effectiveness (for health outcomes) of most therapies and preventive interventions? 2 Efficacy/effectiveness of interventions for otherwise fatal conditions?	. 1 RCT 2 Nonrandomized trials, case series
(Different Study Designs for Different Questions) 1 Safety, effectiveness of incrementally modified technologies posing no known additional risk?	. 1 Registries
(Different Study Designs for Different Questions) 1 Safety, effectiveness of interventions in diverse populations in real-world settings? 2 Rates of recall or procedures precipitated by false positive screening results?	. 1 Registries, especially to complement findings of available RCTs, PCTs 2 Cohort studies
(Different Study Designs for Different Questions) 1 Complication rates from surgery, other procedures? 2 Identification of a cause of a suspected iatrogenic (caused by a physician or therapy) disorder?	. 1 Registries, case series 2 Case control studies
(Different Study Designs for Different Questions) 1 Incidence of common adverse events potentially due to an intervention? 2 Incidence of rare or delayed adverse events potentially due to an intervention?	. 1 RCTs, nested case-control studies, nof-1 trial for particular patients, surveillance, registries 2 Surveillance; registries; n-of-1 trial for particular patients; large, long-term RCT if feasible