Randomisation

Randomisation

Randomisation is known as gold standard as a form of clinical research, it is seen as one of the effective and reliable forms of research methods (ref)
The key features will be looked at randomisation this will be looking at random assignment and random concealment. (ref)
Randomised controlled trails is done by comparative study this is done by whereby subjects are randomly assigned to a form of treatment group or a control group. (ref)
One of the main aims is to test and hypothesis, this is to see if there is a cause and effect of the relationship exist between the two interventions.
One of the aims is to eliminate bias which may this may influence the overall outcome of the study so will call into question the validly of the results of the study.
The main four main components to a random controlled study these are randomisation, blinding, experimentation and use of a control group . These four components look at the efficacy of the intervention.
Randomisation is one of the key elements to RCT this is because it
1)is respresentative of the population
2)that participants have equal chance of receiving the intervention
3) that ensure that both groups baseline characteristics which can influce the outcome of the study are equally districted.
4) the most importantly that the investigator to isolate and quantify the effect of the intervention while simultaneously minimising the effect of other variables

 
Random assisgment and allocation concealment are two separate but two interrelated features.
Ramdom assignment is only described briefly in research articles but generating a random number sequence should be clearly stated as ascertain the appropriate of this approach to this treatment or the control group.
This used to be done through either flipping a coin or throwing a dice. Random numbers are done through tables in statistical textbooks or through computer software which can generate a process of numbers which unpredictable.

The main thing is that it is by chance and it is not done in a systematic way such as by using an odd or even number as this is done in a predicable way this could be bring selective basis by influencing the investigator or the subjects.
Using a unrestricted techniques are reliable, cost effective and seen as fool proof.
Simple randomisation using a random number table to generate a sequence is not a new approach and is often cited in the literature however the actual method of obtaining the sequences and assigning the participants to a number corresponding to either the treatment or control groups is frequently excluded in studies. As in this study ——–

Although what ever method is used it is important that the method is kept concealed from the investigators this will stop the any form of undermining of the random assignment. This will stop any form of having influence over the statistical analsys and the overall outcome of the study.

Simple randomiation is not infallible and is open to chance especially when there is small sample. Chance bais can often result in variation in demographic data at baseline between groups which cannot be attributed to either random assignment this may influence the outcome of the study. This can be outline in the treatment group and the control group.

Allocation concealment from both the investigator and the participants. This should be tamper proof cannot be seen by the investigator or the participants. One of the most reliable methods is to have an independent assessor is to undertake remote randomisation this is to conceal the allocation from both the participants and the investigaora proor to starting the study. This involves contracting an independent assessor from a telephone call centre they have no prio knowledge of either the trail or the particpants. Investigators were then told who to put into their groups either the treatment or the control group.
The actual allocation concealment producdure begins on receipt of the participant details including their eligibility and consent to be included in the trail and formually ends once participant have been enrolled and assigned to a groups.
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