Maturitas, alongside many other journals, aims to increase the transparency and trust
in clinical research by promoting accurate and complete reporting of the results of
clinical trials by recommending the use of reporting guidelines, in particular the
CONSORT 2010 Statement for randomised clinical trials [
[1]
]. This enables the critical assessment of methodological quality, examination of possible
biases and comparison of findings both beneficial and harmful across different studies.
However these guidelines only address the transparency and clarity of reporting and
not the actual conduct of the study and there is increasing evidence that clinical
trials results are not being fully and accurately disclosed and that critical information
regarding study methods and outcomes are frequently missing or incomplete [
2
,
3
].To read this article in full you will need to make a payment
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References
- CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials.BMJ. 2010; 340 (PMID: 20332509): c332
- Empirical evidence for selective reporting of outcomes in randomised trials: comparison of protocol to published articles.JAMA. 2004; 291: 2457-2465
- Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols.J Clin Epidemiol. 2012; 65: 602-609
- SPIRIT 2013 Statement: defining standard protocol items for clinical trials.Ann Intern Med. 2013; 158: 200-207
- Developing a guideline for clinical trial protocol content: Dlephi consensus survey.Trials. 2012; 13: 176
- SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.BMJ. 2013; 346: e7586
Article info
Publication history
Published online: February 27, 2014
Identification
Copyright
© 2014 Published by Elsevier Inc.
