Outcome reporting discrepancies between trial entries and published final reports of orthodontic randomized controlled trials

Marianna Koufatzidou · Despina Koletsi · Padhraig S. Fleming · Argy Polychronopoulou · Nikolaos Pandis

44 citations0/0 files storedEuropean Journal of Orthodontics

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Meta-analysis and systematic reviews Academic Publishing and Open Access Pharmaceutical industry and healthcare

Abstract

BACKGROUND/OBJECTIVES: The aim of this study was to identify outcome-related discrepancies between registry trial entries and final published reports in orthodontic randomized controlled trials (RCTs). The percentage of registered orthodontic RCTs was also recorded. MATERIALS/METHOD: Five trial registries, ClinicalTrials.gov (https://clinicaltrials.gov/), International Standard Randomised Controlled Trial Number registry (http://www.isrctn.com/), European Union Clinical Trials Register (https://www.clinicaltrialsregister.eu/), Australia New Zealand Clinical Trials Registry (http://www.anzctr.org.au/) and Clinical Trials Registry of India (www.ctri.nic.in/) were searched up to April 2018 in order to identify completed orthodontic RCTs. The unique trial identifier, the title and authors name were used to search for publications based on entries within Google (https://www.google.com), Google Scholar (https://scholar.google.gr/) and MEDLINE via PubMed (https://www.ncbi.nlm.nih.gov/pubmed/). Outcome reporting discrepancies and a number of other entry/publication characteristics were recorded including timing of registration, type of journal/publication, significance of the primary outcome in the final report. The number of trials registered among the total number of published RCTs in orthodontics was recorded within the time span assessed. RESULTS: One hundred and twenty-four entries were identified for completed orthodontic RCTs, whereas 53 of those were related to published final reports. Outcome reporting discrepancies were ascertained for 47 per cent of publications (n = 2 5); discrepancies were more prevalent for non-primary outcomes (n = 21, 40 per cent). Only 16 per cent of the published orthodontic RCTs had been registered. LIMITATIONS: Only a subset of trial entries were assessed as these were related to publication records. CONCLUSIONS/IMPLICATIONS: Registration of clinical trials in orthodontics remains far from universal. A significant level of outcome reporting discrepancy was observed within this subset of registered trials.

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References

2010Cochrane Handbook for Systematic Reviews of Interventions 2008Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias 2009Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials 2015Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration 2013Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals 2018Promoting public access to clinical trial protocols: challenges and recommendations 2015Outcome Discrepancies and Selective Reporting: Impacting the Leading Journals?2014The Reporting Quality of Randomized Controlled Trials in Orthodontics

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