Randomized Controlled Trial

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Randomized Controlled Trials (RCT)



Description

Randomized Controlled Trial is a type of an experiment in which all subjects of the experiment are randomly assigned to groups to receive or not to receive a substance or intervention that is being studied. The result of the experiment is derived from the comparison of the control group results with results from the variable group.



History

Earliest mention of the idea of a controlled study can be found in the Book of Daniel 1:11-16 where Daniel has proposed and participated in the study that compared a group who ate “vegetables and water” for ten days with a group that ate “royal food and wine” from the table of Nebuchadnezzar the king of Babylon. The time frame puts this at around 600 B.C. The result of the experiment reviled that group who had vegetarian diet were better nourished than group who consumed royal food.



Principal use

According to Wikipedia, randomized control trials are mostly used by healthcare services and health technologies such as pharmaceuticals, medical devices or surgery. RCTs are mostly used for clinical studies. Educational social and judicial sectors of science also take advantage of RTCs



Advantages:

The main advantage of this method is in its name – randomization. Randomization, if done properly, eliminates bias from the study, it ensures that characteristics of participants will be evenly distributed across all groups that participate in the experiment.


Disadvantages:

According to Harald O. Stolberg et al: “During the past 10 years, randomized controlled trials have been the subject rather than the tool of important, albeit isolated, research efforts usually designed to generate empiric evidence to improve the design, reporting, dissemination, and use of randomized controlled trials in health care. Such studies have shown that randomized controlled trials are vulnerable to multiple types of bias at all stages of their work span.” Another disadvantage is the cost of the study. For the study to have more power its population has to be as large as possible which can be very costly.


Examples in medical informatics:

There are many different studies in Biomedical informatics that take advantage of Randomized Control Trials these are just a few of them:
• BL Rotman, AN Sullivan, TW McDonald, BW Brown, P DeSmedt, D Goodnature, MC Higgins, HJ Suermondt, C Young and DK Owens A randomized controlled trial of a computer-based physician workstation in an outpatient setting: implementation barriers to outcome evaluation .

• Ida Sim, , Ben Olasov and Simona Carini Department of Medicine, Program in Biological and Medical Informatics, University of California, 3333 California St., Suite 435 Q, San Francisco, CA 94143-1211, USA . Available online 8 April 2004. An ontology of randomized controlled trials for evidence-based practice: content specification and evaluation using the competency decomposition method.

• William T. Lester, MD, MS, Richard W. Grant, MD, MPH, G. Octo Barnett, MD, Henry C. Chueh, MD, MS Massachusetts General Hospital, and Harvard Medical School, Boston, Mass, USA. Randomized Controlled Trial of an Informatics-based Intervention to Increase Statin Prescription for Secondary Prevention of Coronary Disease.


References:

• Canadian Institute of Health Research. Randomized Controlled Trials (2006-2007) (Archived)
• Wikipedia. Randomized controlled trial.
• Harald O. Stolberg, Geoffrey Norman and Isabelle Trop. Randomized Controlled Trials