Mislabeling controlled clinical trials (CCTs) as "randomized clinical trials (RCTs)" in dental specialty journals

Abstract

Objectives: This study aimed to investigate whether studies published in dental journals with the highest impact factor, representing the 5 major dental specialties and titled as randomized clinical trials (RCTs) are truly RCTs. A second objective was to explore the association of journal type and other publication characteristics on correct classification.

Methods: The American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), the British Journal of Oral and Maxillofacial Surgery (BJOMS), the International Journal of Prosthodontics (IJP), the Journal of Clinical Periodontology (JCP), and the Journal of Endodontics (JOE) were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed using descriptive statistics, and univariable and multivariable examination of statistical associations via ordinal logistic regression modeling (proportional odds model).

Results: A total of 222 trials were identified. From the included trials, 88 (39.64%) were considered to be RCTs, 107 (48.20%) were considered to be of unclear status, and 27 (12.16%) were not considered as RCTs. In the multivariable analysis among the included variables, journal type, involvement of statistician, year of publication, multicenter trial, and number of authors were significant predictors of correctly classifying a study as an RCT versus no RCT and of unclear status.

Conclusions: This study indicates the need for clear and accurate reporting of clinical trials and the need for educating investigators on RCT methodology.