Fitz9. Ch3: Epidermiology Flashcards
Provide the highest proof of an effect by minimizing bias but does not generalize well to all members of the population
Most commonly used and recognized of the experimental studies
Clinical trials
How patients interact with their health care and disease
Patient oriented research
How an individual receives health care
Health services research
Course of the disease
Natural history of disease
How an individual is affected by an illness
Burden of disease
Observation of primary interest
Outcome
Strongest association between a risk factor or intervention and an outcome
Causal association
Likelihood of developing a disease
Risk factor
Measure efficacy
Explanatory studies
How well an intervention works in the real world
Effectiveness
Study repeated using the same study design would find the same results
Internally valid
Study was repeated using many other study designs will represent reproducible results
Externally valid
Disease status or having a risk factor of interest
Prospective study
Follows a Group of patients over time and monitors the effect of a risk factor or exposure on the development of an outcome
Cohort
Retrospective
Case-control study
Experimental Phase studies 1 2 3 4
- Normal Humans; evaluate drug’s safety, dose, tolerability, PK, PD
- With disease; INITIAL efficacy studies
- / pivotal studies: COMPARATIVE efficacy studies (treatment versus placebo)
- / post marketing studies/ effectiveness: general population; FDA approval for marketing
Large sample studies or Peto studies that focus on understanding how an intervention works in the routine clinical settin
Pragmatic trials
Scale for grading quality of evidence and strength of recommendation
GRADE scale (Grading of Recommendations, Assessment, Development and Evaluation)
Scale for grading the evidence for diagnostic Tests, prognostic markers. And harm
OCEBM Scale (Oxford Centre for evidence-based medicine)
Frequency of disease relevant for chronic diseases
Prevalence
New cases
Incidence
Difference between EFFICACY and effectiveness
Patient selection, Motivated patients and adherence to research protocol, Investigators, Clinical response determined at, Maximize validity
EFFICACY in an ideal setting
Patient selection is stringent
Highly motivated patients and strict adherence to research protocol,
Highly trained Investigators,
Clinical response determined at short term time,
Maximize internal validity