CONSORT endorsement improves the quality of reports of randomized clinical trials in dentistry

Sarkis‐Onofre, Rafael; Poletto-Neto, Victório; Cenci, Maximiliano Sérgio; Moher, David; Pereira‐Cenci, Tatiana

doi:10.1016/j.jclinepi.2020.01.020

Cited by 31 publications

(19 citation statements)

References 25 publications

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“…To improve the reporting quality of RCTs, the CONsolidated Standards Of Reporting Trials (CONSORT) Statement was developed (Begg et al 1996), with subsequent revision and update (Moher et al 2001; Moher et al 2010). Extensive research has shown that the endorsement of the CONSORT statement can improve the reporting of RCTs (Turner et al 2012; Sarkis-Onofre et al 2017; Sarkis-Onofre et al 2020). However, the CONSORT 2010 is mainly focused on RCTs using a 2-arm parallel-group design (Moher et al 2010).…”

Section: Introductionmentioning

confidence: 99%

Quality of Split-Mouth Trials in Dentistry: 1998, 2008, and 2018

Qin

Hua

et al. 2020

J Dent Res

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The objectives of this study were to assess the reporting quality and methodological quality of split-mouth trials (SMTs) published during the past 2 decades and to determine whether there has been an improvement in their quality over time. We searched the MEDLINE database via PubMed to identify SMTs published in 1998, 2008, and 2018. For each included SMT, we used the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 guideline, CONSORT for within-person trial (WPT) extension, and a new 3-item checklist to assess its trial reporting quality (TRQ), WPT-specific reporting quality (WRQ), and SMT-specific methodological quality (SMQ), respectively. Multivariable generalized linear models were performed to analyze the quality of SMTs over time, adjusting for potential confounding factors. A total of 119 SMTs were included. The mean overall score for the TRQ (score range, 0 to 32), WRQ (0 to 15), and SMQ (0 to 3) was 15.77 (SD 4.51), 6.06 (2.06), and 1.12 (0.70), respectively. The primary outcome was clearly defined in only 28 SMTs (23.5%), and only 27 (22.7%) presented a replicable sample size calculation. Only 45 SMTs (37.8%) provided the rationale for using a split-mouth design. The correlation between body sites was reported in only 5 studies (4.2%) for sample size calculation and 4 studies (3.4%) for statistical results. Only 2 studies (1.7%) performed an appropriate sample size calculation, and 46 (38.7%) chose appropriate statistical methods, both accounting for the correlation among treatment groups and the clustering/multiplicity of measurements within an individual. Results of regression analyses suggested that the TRQ of SMTs improved significantly with time ( P < 0.001), while there was no evidence of improvement in WRQ or SMQ. Both the reporting quality and methodological quality of SMTs still have much room for improvement. Concerted efforts are needed to improve the execution and reporting of SMTs.

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Section: Introductionmentioning

confidence: 99%

Quality of Split-Mouth Trials in Dentistry: 1998, 2008, and 2018

Qin

Hua

et al. 2020

J Dent Res

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“…Recent study has assessed the impact of the CONSORT endorsement by dental journals regarding CT reporting completeness. The findings demonstrated a benefit of the CONSORT endorsement; however, the authors highlighted that there are still serious problems in reporting CT methodological aspects in dentistry 31 . Thus, CONSORT is useful to improve the report, but it is essential to remind that it has a limited effect on the methodology quality.…”

Section: Clinical Trial Factors That Could Affect Systematic Review Cmentioning

confidence: 92%

Knowledge synthesis: How to improve the use of evidence from clinical trials?

Sarkis‐Onofre

Agostini

2020

Int J Paed Dentistry

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Background The value of systematic reviews (SRs) is determined by methodology and reporting quality of primary studies and how the SR is conducted and reported. Aim This study discusses key aspects of clinical trials (CTs) that might affect the value of SRs. Design Narrative review. Results We highlighted the following CT factors that could affect SR value: Defining the purpose of CTs is important because it could directly impact whether an SR question is appropriately answered and formulated; choose the most appropriate intervention to answer a proposed SR question is critical because we can exclude or include different studies, directly influencing selection bias; when conducting SRs, the study's search must be restricted to equal or highly similar comparison groups, allowing suitable comparisons of the outcomes’ estimates; in SRs, it may be interesting to explore the effect of the most common definition of the disease used in clinical practice, being useful in evidence‐based dentistry and easily translated to daily practitioners; and deficiencies in CT reporting can lead to unusable reports, biased results, and conclusions. Conclusion All aspects discussed were found to be important for improving the use of evidence from CTs.

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“…The Consolidated Standards of Reporting Trials (CONSORT) 30 is an evidence‐based set of recommendations that comprise a checklist with 25 essential items, and a flow diagram, that must be reported by a well‐designed and conducted randomised clinical trial. The efficacy of CONSORT has been recognised worldwide: it is currently known to be endorsed by over 600 biomedical journals, and the improvement in the report of randomised clinical trials with its use has been proven in several studies 6,7 . Several CONSORT extensions exist, such as for orthodontic trials 31 and can be found on the EQUATOR Network library website (https://www.equator-network.org/library/).…”

Section: Use Of Reporting Guidelinesmentioning

confidence: 99%

“…Therefore, there is a considerable need to advance these discussions about transparency, integrity and especially about reducing waste in dental research, following the movement started some years ago in the medical sciences 38 . This overall lack of transparency and good reporting was already reported in dental literature 6,7,39 …”

Section: Case Study—the Status Of Rcts On Paediatric Dentistrymentioning

confidence: 99%

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Transparency in clinical trials: Adding value to paediatric dental research

Cenci

Franco

Raggio

et al. 2020

Int J Paed Dentistry

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Background Even though considered as studies with high methodological power, many RCTs in paediatric dentistry do not have essential quality items in their design, development, and report, making results’ reliability questionable, replication challenging to conduct, wasting time, money, and efforts, and even exposing the participants to research for no benefit. Aim We addressed the main topics related to transparency in clinical research, with an emphasis in paediatric dentistry. Design We searched for all controlled clinical trials published from January 2019 up to July 2020 in the three paediatric dentistry journals with high journal Impact Factor, indexed on Medline. These papers were assessed for transparency according to Open Science practices and regarding reporting accuracy using some items required by CONSORT. Results 53.6% of the studies declared registration, 75% had sample size calculation, 98.2% reported randomisation, and from those, 65.4% explained the randomisation method. Besides that, no study shared their data, and 6.8% were published in open access format. Conclusions Unfortunately, a large proportion of RCTs in paediatric dental research show a lack of transparency and reproducibility.

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CONSORT endorsement improves the quality of reports of randomized clinical trials in dentistry

Cited by 31 publications

References 25 publications

Quality of Split-Mouth Trials in Dentistry: 1998, 2008, and 2018

Quality of Split-Mouth Trials in Dentistry: 1998, 2008, and 2018

Knowledge synthesis: How to improve the use of evidence from clinical trials?

Transparency in clinical trials: Adding value to paediatric dental research

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