Abstract

BackgroundA systematic review of the evidence should be undertaken to support the justification for undertaking a clinical trial. The aim of this study was to examine whether reports of orthodontic Randomised Clinical Trials (RCTs) cite prior systematic reviews (SR) to explain the rationale or justification of the trial. Study characteristics that predicated the citation of SR in the RCT report were also explored.Material and methodsOrthodontic RCTs published between 1st January 2010 to 31st December 2020 in seven orthodontic journals were identified. All titles and abstracts were screened independently by two authors. Descriptive statistics and associations were assessed for the study characteristics. Logistic regression was used to identify predicators of SR inclusion in the trial report.Results301 RCTs fulfilling the eligibility criteria were assessed. 220 SRs were available of which 74.5% (N = 164) were cited, and 24.5% (N = 56) were not included but were available in the literature within 12 months of trial commencement. When a SR was not included in the introduction or no SR was available within 12 months of trial commencement, interventional studies were commonly cited. The continent of the corresponding author predicated the possibility of inclusion of a SR in the introduction (OR 0.36; 95% CI 0.18–0.71; p = 0.003).ConclusionsA quarter of orthodontic RCTs (24.5%) included in this study did not cite a SR in the introduction section to justify the rationale of the trial when a relevant SR was available. To reduce research waste and optimal usage of resources, researchers should identify or conduct a systematic review of the evidence to support the rationale and justification of the trial.

Highlights

  • With a wealth of trials being published in orthodontics, it is incumbent on researchers to ensure transparent reporting of interventional studies

  • A quarter of orthodontic Randomised Clinical Trials (RCTs) (24.5%) included in this study did not cite a systematic review (SR) in the introduction section to justify the rationale of the trial when a relevant SR was available

  • Within this sub-group, SRs were more likely to be included if the RCT was published in 2020 (75.6%), published in the European Journal of Orthodontics (EJO) (76.1%), and had a corresponding author based in Europe (80.0%)

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Summary

Introduction

With a wealth of trials being published in orthodontics, it is incumbent on researchers to ensure transparent reporting of interventional studies. Meta-epidemiological studies aiming to ascertain the proportion of interventional trials having cited an appropriate SR have indicated that many trials still do not cite a relevant SR in their introduction as a justification for its undertaking [6,7,8]. Neither has this improved with successive reporting, highlighting the need for trial contextualisation [7, 9, 10]. The aim of this study was to examine whether reports of orthodontic Randomised Clinical Trials (RCTs) cite prior systematic reviews (SR) to explain the rationale or justification of the trial. Study characteristics that predicated the citation of SR in the RCT report were explored

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