Format

Send to

Choose Destination
Int J Nurs Stud. 2015 Jun;52(6):1071-9. doi: 10.1016/j.ijnurstu.2014.11.008. Epub 2014 Nov 18.

Endorsement of the CONSORT guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: A cross-sectional analysis.

Author information

1
School of Nursing, University of Auckland, Auckland, New Zealand; National Institute for Health Innovation, University of Auckland, Auckland, New Zealand. Electronic address: a.jull@auckland.ac.nz.
2
School of Nursing, University of Auckland, Auckland, New Zealand; School of Population Health, University of Auckland, Auckland, New Zealand.

Abstract

OBJECTIVE:

To establish the reporting quality of trials published in leading nursing journals and investigate associations between CONSORT Statement or trial registration endorsment and reporting of design elements.

METHODS:

The top 15 nursing journals were searched using Medline for randomised controlled trials published in 2012. Journals were categorised as CONSORT and trial registration promoting based on requirements of submitting authors or the journal's webpage as at January 2014. Data on sequence generation, allocation concealment, follow up, blinding, baseline equivalence and sample size calculation were extracted by one author and independently verified by the second author against source data.

RESULTS:

Seven journals were CONSORT promoting and three of these journals were also trial registration promoting. 114 citations were identified and 83 were randomised controlled trials. Eighteen trials (21.7%) were registered and those published in trial registration promoting journals were more likely to be registered (RR 2.64 95%CI 1.14-6.09). We assessed 68.7% of trials to be low risk of bias for sequence generation, 20.5% for allocation concealment, 38.6% for blinding, 55.4% for completeness of follow up and 79.5% for baseline equivalence. Trials published in CONSORT promoting journals were more likely to be at low risk of bias for blinding (RR 2.33, 95%CI 1.01-5.34) and completeness of follow up (RR 1.77, 95%CI 1.02-3.10), but journal endorsement of the CONSORT Statement or trial registration otherwise had no significant effect. Trials published in CONSORT and trial registration promoting journals were more likely to have high quality sample size calculations (RR 2.91, 95%CI 1.18-7.19 and RR 1.69, 95%CI 1.08-2.64, respectively).

CONCLUSION:

Simple endorsement of the CONSORT Statement and trials registration is insufficient action to encourage improvement of the quality of trial reporting across the most important of trial design elements.

KEYWORDS:

CONSORT Statement; Randomised controlled trials; Reporting quality; Sample size calculation; Trial registration

PMID:
25540865
DOI:
10.1016/j.ijnurstu.2014.11.008
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center