How well do orthodontic RCTs comply with CONSORT guidelines?

OBJECTIVES: To assess the changes in compliance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomized controlled trials (RCTs) in four orthodontic journals. To assess whether reporting of randomization, concealment, and blinding has improved. METHODS: Electronic hand searching was undertaken to identify orthodontic RCTs published in four orthodontic journals from January 2016 to June 2017 (T1) and from January 2019 to June 2020 (T2). The journals were the American Journal of Orthodontics and Dentofacial Orthopaedics (AJO-DO), Angle Orthodontist (AO), European Journal of Orthodontics (EJO), and Journal of Orthodontics (JO). Each item on the CONSORT checklist was scored as either reported, not reported, or not applicable for each paper reporting an RCT. RESULTS: The study included 69 papers reporting an RCT published in T1 and 64 RCTs published in T2. The median CONSORT score in T1 was 48.7% (interquartile range [IQR] 27.6%, 68.6%) and 67% in T2 (IQR 43.9%, 79.5%). This increase was statistically significant (P = 0.001) and largely attributable to improved reporting in AO (P = 0.016) and EJO (P = 0.023). Reporting did not change significantly in AJO-DO (P = 0.13) or in JO (P = 1.0). Reporting of random allocation sequence generation (OR 2.09; 95% CI 1.01, 4.29) and concealment of allocation (OR 2.27%, 95% CI 1.12, 4.57) were significantly higher in T2 compared with T1. Reporting of blinding did not change significantly. CONCLUSION: Overall reporting of CONSORT items in reports of orthodontic RCTs published in the AJO-DO, AO, EJO, and JO, improved significantly from 2016-17 to 2019-20. This could be improved further by authors, journal referees, and editors adhering to the guidelines.

A retrospective cohort study on the aetiology and characteristics of maxillofacial fractures presenting to a tertiary centre in the UK.

Introduction: Approximately 3 million facial injuries occur annually, some of which result in maxillofacial fractures. The aim of our study was to evaluate the aetiology and characteristics of maxillofacial fractures presenting to the Queen Elizabeth Hospital in Birmingham. Methods: The medical records for 809 patients treated for maxillofacial fractures were retrospectively reviewed between the dates of 01/01/2016 to 30/06/2017. Results: A total of 1381 maxillofacial fractures were recorded. The majority of patients were males (n = 682, 84.3%) with a male:female ratio of 5.59:1. The age group with the highest number of admissions was the 26-50 years age group (n = 395, 48.8%). Assaults was found to be most frequent aetiological factor for maxillofacial fractures in the male cohort and falls was the leading cause of maxillofacial fractures in the female cohort. The most common fractured site in our study was the mandible (n = 599, 43.3%) with the angle and symphysis/parasymphysis regions of the mandible being the most susceptible to injury. Teams that were more frequently involved in the care of these patients included ophthalmology (n = 86) trauma and orthopaedics (n = 53), neurosurgery/neurology (n = 95) teams. Conclusion: Socioeconomic status plays a significant role in the aetiology of facial fractures. Furthermore, assaults and falls were found to be the leading aetiological factors for maxillofacial fractures in the male and female cohorts respectively. There is a need to develop strategies in preventing falls in care homes, and addressing violence in young people through public awareness campaigns via the public health sector to reduce the incidence of such fractures.

Assessing the Compliance of Randomized Controlled Trials Published in Craniofacial Surgery Journals With the CONSORT Statement.

BACKGROUND: Randomized controlled trials (RCTs) are gold standard assessments for healthcare interventions. The Consolidated Standards of Reporting Trials (CONSORT) statement was published to maximize RCT reporting transparency. The authors conducted a systematic review to assess current compliance of RCTs published within craniofacial surgery with the CONSORT statement. METHODS: The Thomson Reuters Impact Factor Report 2016 was consulted to identify craniofacial surgery journals. PubMed was used to search for recent RCTs published within the 5 journals identified. Two independent researchers assessed each study for inclusion and performed data extraction. The primary outcome was compliance of each RCT with the CONSORT statement. Secondary outcomes were the pathology and interventions examined, impact factor, multi-versus-single center, number of authors, and publication date. RESULTS: Eighty-six studies met the inclusion criteria, across which a median of 56% (range 33%-94%) applicable CONSORT items were reported. The 5 least reported items were: trial design (3a); registration number and name of trial registry (23); who generated random allocation sequences, enrolled participants, and assigned participants to interventions (10); sample size determination (7a); mentioning "randomized trial" in the title (1a). CONCLUSION: The compliance of craniofacial surgery RCTs with the CONSORT statement requires improvement. Areas in need are identified, and methods to improve reporting transparency, are discussed.