The reporting of blinding in orthodontic randomized controlled trials: where do we stand?

Salem Abdulraheem · Lars Bondemark

8 citations0/0 files storedEuropean Journal of Orthodontics

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Meta-analysis and systematic reviews Orthodontics and Dentofacial Orthopedics Statistical Methods in Clinical Trials

Abstract

Objective: To analyse in 10 orthodontic journals how many randomized controlled trials (RCTs) performed 'single-', 'double-', 'triple-', or 'outcome assessors blinding' and to evaluate, from the number of RCTs that did not conduct blinding, how many could actually have achieved it. Material and methods: Randomized controlled trials published in 10 orthodontic journals between 1 September 2012 and 28 February 2018 were included. A search was performed in PubMed and conducted for publication type 'randomized controlled trial' for each journal. Two reviewers independently analysed each RCT and registered that blinding was performed and included which specific type. It was also evaluated whether misclassifications of blinding items occurred and whether it was possible to achieve blinding among the RCTs that did not perform blinding. Results: After applying the inclusion criteria, 203 RCTs were assessed, and 61.6 per cent of them had used blinding, with the main type being 'outcome assessors blinding' (40.4%) followed by 'single-blinding' (15.3%), 'double-blinding' (2.5%), and 'triple-blinding' (3.4%). In 38.4 per cent of the trials, no blinding was performed; however, 79.4 per cent of them could have achieved blinding. Fifteen RCTs (7.3%) misclassified the blinding in relation to single-, double-, or triple-blinding. Journals followed the CONSORT (AJODO, EJO, JO, OCR) published together significantly more RCTs that performed blinding than journals not following the CONSORT. Conclusions: Blinding of outcome assessors was the most frequent type, as orthodontic trials are often of intervention design and thereby difficult to mask for patients and trial staff. The misclassifications of blinding items may indicate suboptimal knowledge among researchers and peer-reviewers regarding the definitions for diverse blinding types.

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References

1995Empirical Evidence of Bias 1995Empirical Evidence of Bias 2001Assessing the quality of controlled clinical trials 2001Use of the CONSORT Statement and Quality of Reports of Randomized Trials 2012Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors 2001Physician Interpretations and Textbook Definitions of Blinding Terminology in Randomized Controlled Trials 2017Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study 2002In the dark The reporting of blinding status in randomized controlled trials

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