A randomised controlled trial (RCT) is widely held as the gold standard for clinical trials. This is due primarily to the keyword ‘randomised’. To ensure a measure of fairness and to eradicate as many avenues of bias as possible, researches will, in an RCT, randomly assign to a group of participants both the new treatment they have been toiling away with and either a placebo drug or the standard treatment. This is done to maintain a level of balance and equity in those who receive the new treatment and those receiving the sugar pill or standard treatment.
Randomisation, when carried out properly, is seen by many researchers to be an effective pathway for avoiding bias and confounding. If a group of researchers were to give the new treatment to a group of very healthy, athletic men in their twenties and provide the placebo or standard treatment to a control group consisting of elderly, profuse smokers, the cause-and-effect relationship of the new treatment on patients becomes exceedingly nebulous. One can point to this stark juxtaposition between the two groups and credibly claim that it has affected the results of the trial.
Now smoking is something that can be reliably measured but there are indeed variables that cannot be measured and thus through randomisation, researchers can safeguard their trial against such unknown biases. By making sure the chances of any and each individual to receive the new treatment are equal, researchers improve the reliability of their results and thus, as the great French novelist Marcel Proust once wrote, ‘Chance seems to us then a good and useful thing, for we discern in it as it were rudiments of organisation’.
The primary objective of randomisation is to minimise bias and to create a level of equivalence in the distribution of patients’ characteristics between the new treatment and the standard treatment or placebo. The methodological rigour of RCTs makes them highly rewarding endeavours for both researchers and readers. It is for this reason we ask all clinical researchers to submit their RCTs to either one of ACAMH’s journals – Child and Adolescent Mental Health (CAMH) and the Journal of Child Psychology and Psychiatry (JCPP). We publish RCTs, such as this one published in CAMH in September 2014, which focuses on selective mutism (SM). As an organisation at the forefront of child psychology and mental health, we are always searching for more randomised trials to publish in our journals in the continued pursuit to broaden our collective scientific knowledge and understanding.
Both of our journals require authors to conform to CONSORT 2010 (details can be found in CONSORT Statement) in relation to the reporting of randomised controlled clinical trials, ensuring readers can understand the design and method of a trial along with its analysis and interpretation; also recommended is the Extensions of the CONSORT Statement with regard to cluster randomised controlled trials. In particular, authors must include in their paper a flow chart illustrating the progress of subjects through the trial (CONSORT diagram) and the CONSORT checklist. Additionally, we recommend the Equator Network as a resource on these guidelines for which all methodologies are expected to follow.
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