Four "lessons learned" while implementing a multi-site caries prevention trial.
As the number of dental-related randomized clinical trials (RCTs) increases, there is a need for literature to help investigators inexperienced in conducting RCTs design and implement studies. This commentary describes four "lessons learned" or considerations important in the planning and initial implementation of RCTs in dentistry that, to our knowledge, have not been discussed in the general dental literature describing trial techniques. These considerations are a) preparing or securing a thorough systematic review; b) developing a comprehensive set of study documents; c) designing and testing multiple recruitment strategies; and d) employing a run-in period prior to enrollment. Attention to these considerations in the planning phases of a dental RCT can help ensure that the trial is clinically relevant while also maximizing the likelihood that its implementation will be successful.
Bader
James D
JD
University of North Carolina at Chapel Hill, School of Dentistry, NC 27599-7450, USA. jim_bader@unc.edu
Robinson
Debbie S
DS
Gilbert
Gregg H
GH
Ritter
Andre V
AV
Makhija
Sonia K
SK
Funkhouser
Kimberly A
KA
Amaechi
Bennett T
BT
Shugars
Daniel A
DA
Laws
Reesa
R
D002985:Clinical Protocols; D003625:Data Collection; D003731:Dental Caries / Q000517:prevention & control*; D018865:Dental Research / Q000592:standards; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards; D018579:Patient Selection; D010934:Planning Techniques; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012107:Research Design; D012196:Review Literature as Topic
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