In: Nursing
- Name and describe the gold standard of research design and what makes it the gold standard.
THE GOLD STANDARD OF RESEARCH DESIGN IS :
RANDOMISED CONTROLLED TRIALS (RCT): It is an experiment or study conducted in such a way that as many sources of bias are removed from the process .
For new programmes or new therapies the RCT is No-1 method of evaluation
The basic steps in conducting a RCT include the following :
1.Drawing up a protocol
2.Selecting reference and experimental population
3.Randomisation
4.Manipulation or intervention
5.Follow up
6.Assessment of outcome
RANDOMIZATION:
Randomisation is a statistical procedure by which the participants are allocated into groups usually called "study" and "control" groups
Randomisation is an attempt to eliminate " bias " and allow for comparability .Therotically it is possible to assure comparability by matching
Randomisation is the heart of the control trial .It ensures that investigator has no control over allocation of participants to either study or control group thus eliminating what is known as SELECTION BIAS .
By random allocation every individual gets an equal chance of being allocated into either group or any of the trail groups.
Randomisation is done only after the participant has entered the study that is after having been qualified for the trail and has given his informed consent to participate in the study .
Randomisation is best done by using a table of random numbers
RCT IS GOLD STANDARD BECAUSE:
They deliver highest level of evidence ,due to there potential to limit all sort of bias with the help of blinding technique.
Bias may arise from errors of
assessment of the outcome due to human element.
BIAS ARE FROM THREE SOURCES
1.Subject variation
2.observer bias
3.bias in evaluation
randomisation cannot guard against these sorts of bias nor the size of the sample .In order to reduce this problems a technique known as BLINDING is adopted, which will ensure that outcome is assessed objectively
Blinding can be done in 3 ways :
1.SINGLE BLIND TRAIL
2.DOUBLE BLIND TRAIL
3.TRIPLE BLIND TRAIL
DOUBLE BLINDING is most frequently used