Question

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Discussion Topic 2: Controlled Trials When would the use of a randomised controlled trial be inappropriate? Give a public health example and outline the reasons why conclusion randomised control trial would not be appropriate in this context.

Answer 1

ANSWER :

Randomised controlled trail ( RCT ) is a scientific experiment, aims to reduce source of errors when testing the effectiveness of new treatments. Here randomly allocating subjects to two or more groups. One group is experimental group in which intervention being assessed. Other group called control group, giving placebo or no intervention. These groups are followed for a certain period of time to see how effective the intervention was. The trial may be done blinded ( in which information which may influence the participients is withheld until the experiment is completed ) good blinding may reduce some sources of bias or error.

As it is are most reliable form of scientific evidence in the hierarchy of evidence that influences helth care policy and practice.

EXAMPLE OF RCT WHICH CONTRIBUTED SOME CHANGES IN CLINICAL PRACTICE

  After the FDA ( food and drug administration )approval, the antiarrythmic agent flecained and encainid came to market in 1986 and 1987 respectively their sales increasd to a combined total of around 165000 prescriptions per month in 1989. In that year, a preliminary report of an RCT concluded that the two drugs increased morality. Sales of these drugs then decreased.

THE USE OF RCT INAPPROPRIATE, if the interventions to prevent events thet occur only infrequently ( eg. sudden in infant death syndrome ) and uncommon adverse outcomes ( eg. rare side effect of drugs) would requir RCTs with extremely large sample size and therefore best assessed  by observational studies.

Due to the cost of running RCTs, they usually inspect one or very few variables, rarely reflecting the full picture of a complicatedmedical situation. So RCTs are not recommended in complicated medical situation.

RCT also inappropriate, if a disruptive innovation in medical technology is developed. In these type of study getting ethical approval and patient agreement is very difficult.

RCTs are also inappropriate if RCTs are fully or partially funded by the health care industry ( pharmaceuitical industry) as opposed to government soures. A systematic review published in 2003, found four 1986 to 2002 articles comparing industry sponsored and non-industry sponsored RCTs, in all this articles there was a co-relation of industry sponsorship and positive study outcome.