Outcome reporting discrepancies between trial entries and published final reports of orthodontic randomized controlled trials
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BORIS DOI
Publisher DOI
PubMed ID
29992332
Description
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.
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.
Date of Publication
2019-05-24
Publication Type
Article
Subject(s)
Language(s)
en
Contributor(s)
Koufatzidou, Marianna | |
Koletsi, Despina | |
Fleming, Padhraig S. | |
Polychronopoulou, Argy |
Additional Credits
Series
European journal of orthodontics
Publisher
Oxford University Press
ISSN
0141-5387
Access(Rights)
open.access