Randomized clinical trials provide research results with the highest level of evidence, which may increase the interest for presenting such results. However, not all papers that are published as randomized trials may actually be randomized trials. Koletsi et al. (1) reviewed all papers that had been published as randomized clinical trials in eight orthodontical Journals from 1979 to Jylu 2011 to assess how frequent the phenomenon may be.
Of the 112 reviewed publications only 33 (29.5%) could be methodologically identified as randomized clinical trials, i.e. by reporting of random number generation and concealed allocation. 52 (46.4%) publications had unclear status, and 27 (24.1%) were clearly not randomized clinical trials. The year of publication, number of authors, multi-centre design, and the involvement of a statistician indicated a real randomized trial.
The authors conclude that investigators need to be educated about randomized trial methodology for a clearer and more accurate reporting of clinical trials.
1. Koletsi D, Pandis N, Polychronopoulou A, Eliades T. What’s in a title? An assessment of whether randomized controlled trial in the title means that it is one. Am J Dentofacial Orthop 2012:141:679-685.