Abstract
ObjectivesTo examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time.MethodsWe included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics.ResultsSequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955–2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias.ConclusionsThe risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed.
Highlights
Randomized clinical trials are the ideal type of clinical research to examine the effectiveness of treatment interventions in health sciences [1]
The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed
The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement [2], the Consolidated Standards of Reporting Trials (CONSORT) Statement [3], and recent initiatives such as the International Committee of Medical Journal Editors (ICMJE) statement on clinical trial registration [4], have led to improvements in both the methodological and reporting quality of medical randomized clinical trials [5,6,7]. Adhering to these initiatives is critical to oral health research and practice, as high quality randomized clinical trials contribute largely to the body of evidence measured in systematic reviews and meta-analyses, especially when assessing therapeutic interventions
Summary
Randomized clinical trials are the ideal type of clinical research to examine the effectiveness of treatment interventions in health sciences [1]. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement [2], the Consolidated Standards of Reporting Trials (CONSORT) Statement [3], and recent initiatives such as the International Committee of Medical Journal Editors (ICMJE) statement on clinical trial registration [4], have led to improvements in both the methodological and reporting quality of medical randomized clinical trials [5,6,7] Adhering to these initiatives is critical to oral health research and practice, as high quality randomized clinical trials contribute largely to the body of evidence measured in systematic reviews and meta-analyses, especially when assessing therapeutic interventions. There is evidence that some trials are biased and, due to weaknesses in their methodological characteristics, they tend to exaggerate the magnitude of the treatment effect [15] This emerging evidence raises questions about the validity of trial results for oral health interventions, which dental practitioners use when making day-to-day clinical decisions in dental practice, and which policy makers use more generally when developing clinical practice guidelines
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