EBM revision Flashcards
What do you need to consider when you want to treat a patient with a drug?
- benefits vs harms
- costs
- patient preference
- ethics
- can you use the drug in your patient population?
What is the need for randomisation?
Both the known and unknown characteristics of the study population that might affect the outcome of trial are distributed by chance. This reduces allocation bias as well.
What do these levels of measurement mean?
- Nominal
- Ordinal
- Interval
Nominal- categorical
Ordinal- rank-ordered
Interval- presented as ranges
What are the main biases associated with RCT?
- Allocation bias
- Performance bias
- Detection bias
- Performance bias
- Reporting
What is allocation bias?
Systematic difference that exists in the baseline characteristics between the groups in the trial.
How to reduce allocation bias?
Randomisation using a random sequence generator, allocator concealment
What is performance bias?
Systematic difference in the care given and external factors that may affect outcome that are not the intervention of interest.
How to reduce performance bias?
Blinding the participants and personnel
What is detection bias?
Systematic difference in how outcomes are measured/
How to reduce detection bias?
Blind the outcome assessor
What is attrition bias?
Systematic differences in the groups that have withdrew from the study compared to those who stayed on
What should you be looking for in terms of attrition bias?
incomplete outcome data
What is reporting bias?
Systematic differences between reported and unreported findings
What should you be looking for in terms of reporting bias?
Proof of something that was measured but not reported
What factors may lead to allocation bias if not blinded?
Not wanting to disadvantage patients who are old/young, poor health, vulnerable patients
What are the ethical issues that could be raised from an RCT?
Could we possibly giving patients a drug that could cause a lot of s/e compared to standard treatment and one that may not be as effective?
Are we disadvantaging the control group if this drug is actually more effective
How do we reduce cross-over?
Cluster randomisation
2 Methods of analysis of outcome:
- intention to treat: based on the initial allocation of treatment.
- according to treatment received: treatment received coherent with the protocol of the trial which they were originally allocated to.
Where can you look for study population?
List/register- GP lists, cancer and professional registers, hospital and clinic registers
What are the 3 modes of randomisation?
- Simple
- Cluster
- Stratification
How is simple randomisation conducted?
using random number generator
How is cluster randomisation conducted?
perform in schools, hospitals, gp practices
What is the downside of cluster randomisation?
Special analytical tests need to be conducted to account for the similarities within the groups.
How is stratification randomisation conducted?
Greater proportion of minority groups are recruited to increase power and sample size
What are the non-random methods?
- Systematic
- Convenience
- Snowball
- Street survey
What is the systematic method?
every nth selected
What is the convenience method? and the problem with this?
volunteers recruited –>volunteer bias
What is snowball?
recommendation of a friend from a pre-set requisite
What is street survey?
Open polls and market research
What is bias?
Systematic error in the study design, conduct or analysis that results in deviation from the truth
What is a random error?
All measurements deviate from the centre of target in different directions due to unknown and unpredictable changes in the experiment
What is sampling bias?
Systematic difference in the characteristics of those selected into the study compared to those who weren’t.
What is spectrum bias? Which study is it seen in?
Specific groups inappropriately excluded. DTA
What is interviewer bias?
Error due to interviewer’s subconscious/conscious gathering of data that differs systematically between cases and controls
What is recall bias? When can it be avoided?
incompleteness/inaccuracy recall of prior exposure of interest between cases and controls. Avoided in cohort study
What is recording bias?
Cases have a more detailed recording of data compared to controls.
What is verification bias? what study is it seen in?
Systematic error in DTA where not all participants received both the index and reference standard.