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CHAPTER 7 & 8: Assessing preventive and therapeutic Measures:…
CHAPTER 7 & 8: Assessing preventive and therapeutic Measures: Randomized Trial
IMPORTANT : element
2 aspect
Cross over
planed
unplanned
factorial design
Design issues
Selection of Subject
ALOCATING SUBJECT WITHOUT RANDOMIZATION
studies with out comparison
studi with comparison
historical control
2 Problem : 1. data from medical record is different for the data collection for research purpose
if there are difference in study we not sure that the difference because of the drug or other factor that influence such as living condition and nutrition or lifestyle
stimultaneuos non- randomized controls
assignment system was predictable : the physician to know what assignment of the next patient will be
TB Vaccine : choose the cooperative parent that might be the reaseon why the child is not death because the parent was bring the children to the health care
ALOCATING SUBJECT WITHOUT RANDOMIZATION
Purpose : to prevent any potential biases on the part of the investigator from influencing the assignment of participant to different treatment group.
stratified randomization: to increasing likelihood of comparability of the study group
layer by important variable Ex: age & sex
Data Collection = quality of data
Treatment : Want to get treatment A but in half study does not want to continue with treatment A, or not get treatment A but after that want to get treatment A
Outcome= the desired effect
Prognostic Profile at Entry : the risk factor that can have a big influence to the outcome Ex: Age
Masking
Blinding
Subject not to know which group they are assigned : Physiology factor
Placebo = an inert substance that looks, taste, and smells like the active agent
Studying rates of side effect and reaction
Double Blind
Both of the patent and study personnel (data collector)
Problem posed by non-compliance in randomized trials
Defined : is consider the ideal design for evaluating both the effectiveness and the side effect of new form of intervention
Sampel Size
recrutment and retentin of study participant