Guidelines for reporting randomized controlled trials in paediatric dentistry based on the CONSORT statement
Abstract
Background: The significance of randomized controlled trials (RCT) depends on how thoroughly the results were reported. Reporting of RCTs should be accurate and transparent and encompasses design, implementation, analysis, and results of the trial. The Consolidated Standards of Reporting Trials (CONSORT) statement and its extension were developed to guide the researchers to report clinical trials in a systematic manner. Despite this recommendation, the overall reporting quality of RCTs still remains suboptimal. Aim: To describe the relevance and importance of CONSORT reporting guidelines and explain the items using examples derived from randomized trials published in Paediatric Dentistry. Methods: This is a narrative review that illustrates the importance of reporting items in the CONSORT guidelines from relevant sources. RCTs published in the International Journal of Paediatric Dentistry between 2017 and 2020 were identified from PubMed and Scopus databases and through handsearching. An explanation has been provided for each of the 37 items in the 2010 CONSORT checklist and 17 items in the CONSORT extension for reporting abstracts. Conclusion: This explanation and elaboration document would enable investigators to report trials in Paediatric Dentistry with accuracy and transparency as well as for reviewers and editors in evaluating the suitability of RCTs for publication.
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The study was performed and reported in accordance with the CONSORT statement.
“This study was performed and reported in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement [30].”
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- Authors
- Jayaraman, J.
- Affiliations
- The University of Texas at San Antonio Health Science Center (US)
- Corresponding author
- Jayaraman, Jayakumar
- ORCID
- Jayaraman, Jayakumar
- Venue
- International Journal of Paediatric Dentistry
- Publisher
- Wiley
- Published
- 2020-10-22
- Volume
- 31
- Issue
- S1
- Pages
- 38-55
- ISSN
- 0960-7439 (ISSN-L)
- 1365-263X
- OpenAlex
- W3088583131
- Cited by
- 26
- References
- 49
- Citations by year
- 2025: 2 · 2024: 8 · 2023: 8 · 2022: 8
- FWCI
- 0.83
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Paediatric Dentistry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- CONSORT statement, reporting guidelines, randomized controlled trials, pediatric dentistry, trial reporting quality
- MeSH terms
- Child, Humans, Pediatric Dentistry, Reference Standards, Randomized Controlled Trials as Topic, Research Report
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