EMB and Study Design Flashcards
Randomisation
Different from random sampling as both groups are the same in all ways
Breaks confounding
Eg random numbers, block allocation, stat softwear
Randomised controlled trials
Evaluate safety and effectiveness of an intervention by comparison with a control group
Randomisation-> breaks confounding
Eg random numbers, block randomisation, stat softwear
Allocation concealment
Blinding
Allocation concealment
Masking randomisation process before a patient is entered into the study
Study team don’t know which group next patient will be in
Avoids selection bias
Blinding
Concealment after allocation Reduces ascertainment bias Single-> patient Double-> doctor and patient Triple-> outcome assessor as well Means causation can be assessed
Dealing with withdrawal
Causes attrition bias as sample no longer random
Intention to treat or per protocol
Intention to treat analysis
Analysed based on initial treatment allocation and not treatment eventually received
Avoids attrition bias and cross over
Doesn’t require observation of compliance status
Includes those who drop out in results
Provides information about the potential effects of treatment policy rather than specific treatment
Missing data-> make assumptions or last value carried forwards
Per protocol analysis
Only take results from patients who completed the trial
Effected by attrition bias
Cohort study
To measure incidence of disease
Traditionally prospective-> study pop is disease free at beginning of study -> asses temporal relationship
Exposure variables tend to be common
Risk is compared
Multiple diseases and/or exposures can be examined
Time consuming and expensive
Vulnerable to attrition bias, selection bias and confounding
Real world-> causality
Inefficient for rare diseases
Sample then separate in to exposure/non exposure
Case control studies
Asses risk factors for rare diseases
Source pop-> cases and controls-> sample of each-> exposure
Select participants based on presence or absence of disease, ideally incidence cases
Odds ratio
Retrospective
Less people need to be studied as you can be sure to recruit enough
Investigation of multiple exposures
Can’t calculate prevalence as not a random sample
Only 1 disease
Vulnerable to selection and recall bias, confounding
Real world
Bias
Systematic distortion from the true value
Avoid by-> randomisation, matching, post hoc adjustment
Error
Non random variation around the true value
Not all the data
Avoid by large sample and lowering significance level
Minimised not corrected
Meta analysis
A systematic review with quanta give evidence synthesis
Examine distribution of evidence
Improve generalisability
Best study design to answer question
Therapy/prevention-> rct
Diagnosis-> case control
Cause/risk-> cohort/case control
Prognosis-> cohort
Qualitative research
Any research that uses data that do not indicate ordinal values
Focuses on people and processes-> understand human beliefs and interactions
Searching for participants meanings
Detailed description
Explores real world detail
Flexible designs
Inductive reasoning
Useful when little is known or few potential participants
Support quantitative research-> triangulation
Discourse analysis
Discourse is central
Not interview bases
Transcript captures all features of interaction
Language explained in terms of construction and function
Analyse written, vocal or sign language or any semiotic event