drug lit

  1. observational studies
    • used to gain and understand of disease prevalence and treatment effectiveness
    • NOT efficacy!!!!
    • real world studies 
    • more representative of populations 
    • allow inclusions that are usually excluded 
    • short time frame 
  2. effectiveness vs efficacy
    effectiveness: does the drug work and do what it is supposed to in the real world (look at compliance, side effects, cost, dosing schedule)

    efficacy: does the drug mechanism work in an ideal population 
  3. 5 observational studies
    • case report
    • case series
    • case- control
    • cross sectional
    • cohort 
  4. Case Report
    aka descriptive
    • describes some newsworthy clinical occurrence 
    • can alert others to look out for the same occurrence
    • hypothesis generating 
    • clinical narrative

    not primary literature 
  5. Case Series
    aka descriptive but with a few people
    • certain characteristics of a group of pt are described and published 
    • short period of time
    • no controls
    • hypothesis generating 
  6. Case Series
    Advantages and Disadvantage
    easy to write and the observations may be useful to investigators designing a study to evaluate causes or explinations

    good after a  product launch

    very bias= not conclusive 
  7. analytic studies
    studies that are undertaken to test 1 or more specific hypothesis about an exposure and disease risk

  8. Case Control 
    asks what happened- retrospective

    bengin with absence or presence of an outcome and look back in time to see possible risk factors

    select case based off disease

    select controls based off no disease
  9. case control
    select cases and controls from same population

    good for hypothesis generating and testing!

    matching is often used to associate controles with cases on age and gender 
  10. confounding
    dont want to make wrong associations or conclusions 
  11. Case Control Advantages
    good for rare diseases or events, examing conditions that develop over a long period of time and for primary hypothesis

    quick and least evepsive for preliminary data
  12. Case Control Disadvantages
    depend completely on high quality existing records

    require compromises between what rresearch wantes to study

    selection of control group hard

    largest number biases 
  13. Cross Sectional Study
    • asks whats happening (a survey)
    • not based on a period of time, one point in time analysis
    • exposure and outcome are taken at the same point in time
    • can address questions that come about from case series 
  14. Cross section advantages and disadvantages
    quick and cheap

    good for determining the status quo of a disease or condition or diagnostic procedures

    only a snapshot in time- could be misleading information 
  15. cohort study
    • asks what will happen= prospective
    • group of people who have something in common and who reain part of a group over an extended period of time

    • select by some defining characteristics that is thought to be a precursor 
    • examine what happens to the disease over time 
  16. Cohort Study
    2 groups of people (1 has exposure and other does not have exposure)

    investigator follows each group to measure disease incidence 
  17. historical cohort study
    cohort study where information is collected in the past and kept in records

    aka retrospective cohort study
  18. cohort study advantages and disadvantages
    design of choice for studying the cause of a condition, course of the disease or the risk factors

    cause cannot be proven because only observatins and no intervention

    many years needed- can loose patients
Card Set
drug lit
lassila observational