A majority of healthcare studies are conducted using a randomized control trial (RCT). These trials randomly assign participants into groups who either receive or do not receive treatment. However, until the mid-1990s, some of these studies were falling victim to inadequate reporting, thereby causing confusing and potentially biased results. Reviewing the quality of RCTs in various surgical specialties by using standardized methods is becoming a common practice.

In an effort to test the validity of trial results pertaining to cleft lip and palate (CL/P), the researchers of a study published in the current issue of The Cleft Palate-Craniofacial Journal analyzed 65 articles that were written based on RCTs. The articles reviewed spanned a 10-year period from January 1, 2004, to December 31, 2013, and the authors used two tools to assess the articles: the Consolidated Standard of Reporting Trials (CONSORT) checklist and the Jadad Scale.

The CONSORT was launched as a 25-point checklist to assist in the development and reporting of RCTs. The Jadad Scale is a process used to independently assess the methodological quality of a trial.

The researchers were able to substantiate the legitimacy of clinical trials in relation to CL/P by combining the CONSORT checklist to focus on design and reporting and the Jadad Scale to test the quality and methodology of the RCTs. They were specifically focused on the RCT randomization, blinding, and exclusion criteria.

The data suggested that there was a correlation between increasing the number of authors and the positive scores given by the CONSORT checklist and Jadad Scale. It is believed that by including more authors and researchers in the RCT, there will be more checks and balances during publishing, as well as a stronger study design in an effort to coordinate a larger collaboration.

Aside from a large collaboration between authors, the outcome of this study did find deficiencies in the reporting of RCTs, such as implementing randomization, trial blinding, and participant flow. There was strength found in the trial intervention, the outcomes, and the overall interpretation of the data and results. The researchers believe that if studies adhere to the CONSORT checklist, the development of more reliable, concise and unbiased RCTs will be published in all areas of study, including CL/P.

Full text of the article, “Reporting of Randomized Controlled Trials in Cleft Lip and Palate: A 10-Year Review,” The Cleft Palate–Craniofacial Journal, Vol. 54, No. 2, 2017, is available at http://www.cpcjournal.org/doi/full/10.1597/14-267

The Cleft Palate–Craniofacial Journal is an international, interdisciplinary journal reporting on clinical and research activities in cleft lip/palate and other craniofacial anomalies, together with research in related laboratory sciences. It is the official publication of the American Cleft Palate–Craniofacial Association (ACPA).