The reporting quality of split-mouth trials in orthodontics according to CONSORT guidelines: 2015–19

Abstract

Summary Objectives To assess the reporting quality of split-mouth trials (SMTs) in orthodontic journals, and to identify factors associated with better reporting. Materials and methods Seven leading orthodontic journals were hand searched for SMTs published during 2015–19. The CONSORT 2010 guideline and CONSORT for within-person trial (WPT) extension were used to assess the trial reporting quality (TRQ) and WPT-specific reporting quality (WRQ) of included SMTs, respectively. A binary score (0 or 1) was given to each item of the guidelines, and total scores were calculated for TRQ (score range, 0–32) and WRQ (score range, 0–15). Univariable and multivariable linear regression analyses were performed to identify factors associated with TRQ and WRQ. Results A total of 42 SMTs were included. The mean overall scores for TRQ and WRQ were 16.8 [standard deviation (SD) 7.1] and 5.6 (SD 2.3), respectively. Only 11 SMTs (26.2%) presented the rationale for using a split-mouth design. Key methodological items including random sequence generation (22/42, 52.4%), allocation concealment (9/42, 21.4%), and blinding (20/42, 47.6%) were poorly reported. Only six SMTs (14.3%) used a paired method for sample size calculation, and half (21/42, 50.0%) considered the dependent nature of data in statistical analysis. In multivariable analyses, higher TRQ and WRQ were both significantly associated with journal, reported use of CONSORT and funding status. Conclusions The reporting quality of SMTs in orthodontics has much room for improvement. Joint efforts from relevant stakeholders are needed to improve the reporting quality of SMTs and reduce relevant avoidable research waste.

The reporting and methodological quality of split‐mouth trials in oral implantology: A methodological study

“…However, only 13% of the included studies considered this dependency in sample size calculation. In addition, we found that the ignorance of dependency in statistical analysis was still common in oral implantology, which is similar to previous studies on SMTs in dentistry (Lesaffre et al, 2007; Qin et al, 2020) and orthodontic journals (Qin et al, 2021). Although clustering of data can occur in all trial designs where multiple measurements are recorded within a participant, it is a common phenomenon in dental research (Fleming et al, 2013).…”

“…This limitation has been reported in several dental fields (Hujoel & DeRouen, 1992;Qin et al, 2021). In oral implantology, carryacross effects may not be much of a problem as most interventions are localized.…”

“…independently and in duplicate, using the CONSORT 2010 guideline (Moher et al, 2010) and its extension for WPT (Pandis et al, 2017). We used a dichotomous scoring approach to score each item as in our previous similar studies (Qin et al, 2020(Qin et al, , 2021): an item was scored "1" if it was adequately reported, and "0" if inadequately reported or not reported. All discrepancies were resolved through discussion with the other authors.…”

Abstracts of randomized controlled trials in the field of dentofacial trauma: Reporting quality and spin

“…However, according to empirical studies, only a few SCIE‐indexed dental journals have endorsed the CONSORT for Abstracts guideline 9 . Sub‐optimal reporting of RCT abstracts has been found in general medical journals, 10 general dental journals, 11 endodontics, 12 prosthodontics 13 and orthodontics 14,15 . In the field of dentofacial trauma, the reporting quality of RCT abstracts remains unknown.…”

“…9 Sub-optimal reporting of RCT abstracts has been found in general medical journals, 10 general dental journals, 11 endodontics, 12 prosthodontics 13 and orthodontics. 14,15 In the field of dentofacial trauma, the reporting quality of RCT abstracts remains unknown.…”