TY - JOUR
T1 - The reporting of study limitations in randomized controlled trials published in the leading dental journals
T2 - Is it sufficient?
AU - Stöckli, Simone
AU - Koufatzidou, Marianna
AU - Seehra, Jadbinder
AU - Pandis, Nikolaos
N1 - Publisher Copyright:
© 2023 The Author(s)
PY - 2023/9
Y1 - 2023/9
N2 - 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.
AB - 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.
KW - Dentistry
KW - Limitations
KW - Randomised Clinical Trials
KW - speciality journals
UR - http://www.scopus.com/inward/record.url?scp=85164428800&partnerID=8YFLogxK
U2 - 10.1016/j.jdent.2023.104603
DO - 10.1016/j.jdent.2023.104603
M3 - Article
C2 - 37414393
AN - SCOPUS:85164428800
SN - 0300-5712
VL - 136
JO - Journal of dentistry
JF - Journal of dentistry
M1 - 104603
ER -