Stöckli, Simone; Koufatzidou, Marianna; Seehra, Jadbinder; Pandis, Nikolaos (2023). The reporting of study limitations in randomized controlled trials published in the leading dental journals: Is it sufficient? Journal of dentistry, 136, p. 104603. Elsevier 10.1016/j.jdent.2023.104603
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OBJECTIVES
Adequate reporting of limitations is crucial to enable clinicians to accurately interpret the clinical trial findings. This meta-epidemiological study aimed to evaluate whether study limitations are reported in full-text articles of randomized controlled trials (RCTs) published in the leading dental journals. Associations between the trial characteristics and the reporting of limitations were also explored.
METHODS
RCTs published between 1st January and 31st December in the years 2011, 2016 and 2021 were identified from the 12 high impact factor dental journals (general and specialty). RCT characteristics were extracted, and reporting of limitations was recorded for the selected studies. Descriptive statistics were calculated for trial and limitations related characteristics. Univariable ordinal logistic regression models were fit to explore univariable associations between trial characteristics and reporting of limitations.
RESULTS
Two hundred and sixty-seven trials were included and analyzed. Most RCTs were published in 2021 (40.8%), had authors based in Europe (50.2%), did not have a statistician involved (88.8%) and assessed a procedure/method intervention type (40.5%). The reporting of trial limitations was generally sub-optimal. More recent trials and studies with a published protocol were associated with better reporting of limitations. The type of journal was a significant predictor for limitation reporting.
CONCLUSIONS
Within this study, the clear reporting of study limitations in the manuscripts of dental RCTs is sub-optimal and requires improvement.
CLINICAL SIGNIFICANCE
The reporting of limitations should not be viewed as a weakness of a trial but due diligence, so clinicians can fully interpret the impact of these limitations on both the validity and generalisability of the results.
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > School of Dental Medicine > Department of Orthodontics |
UniBE Contributor: |
Stöckli, Simone, Pandis, Nikolaos |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1879-176X |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
10 Jul 2023 12:32 |
Last Modified: |
22 Aug 2023 00:15 |
Publisher DOI: |
10.1016/j.jdent.2023.104603 |
PubMed ID: |
37414393 |
Uncontrolled Keywords: |
Dentistry Limitations Randomised Clinical Trials speciality journals |
BORIS DOI: |
10.48350/184567 |
URI: |
https://boris.unibe.ch/id/eprint/184567 |
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