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

https://doi.org/10.1016/j.ijnurstu.2014.11.008Get rights and content

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.

Section snippets

Background

Randomised controlled trials provide reliable evidence of effectiveness for interventions in clinical practice, but validity is dependent on known design elements being properly performed. A determination on trial validity cannot be obtained if the trial report does not provide sufficient information on these design elements, especially with respect to sequence generation, allocation concealment, and blinding (Guyatt et al., 1994). Modest to moderate effects are usually all that can be expected

Selection of journals and trials

This study was conducted between November 2013 and February 2014. We selected 15 leading nursing journals (Table 1) by ranked 5 year impact factor using ISI Web of Knowledge Journal Citation Reports (Science) and whether they had published any RCTs in the year of interest (2012). To determine the latter, we used Medline to search each journal title with the search restricted to publication type limitation (“randomized controlled trial”) and year (2012). All the nursing journals were listed in

Results

One hundred and fourteen citations were identified from the database search (Fig. 1). Sixteen reports were screened out and 98 citations were obtained. Eighty three reports met the inclusion criteria. Nearly two-thirds of the trials (51) were published in five journals, being the International Journal of Nursing Studies, Journal of Clinical Nursing, Journal of Advanced Nursing, Nursing Research, and Oncology Nursing Forum. The sample sizes of the trials were small with an overall median of 85

Discussion

Half the leading 15 nursing journals did not support the CONSORT statement and 80% did not support trials registration as at January 2014, despite the CONSORT Statement being published since 1996 (Begg et al., 1996) and the ICMJE announcement a decade ago that leading medical journals would not publish trials unless they were prospectively registered (De Angelis et al., 2004). Trial registration was low even in journals that promoted registration. Reporting was inadequate with allocation

Conclusions and implications

Randomised controlled trials published in nursing journals still provide insufficient information to support critical appraisal and risk of bias assessments, especially on sequence generation and allocation concealment. Readers are poorly served by continued non-adherence to the CONSORT Statement and trial registration, and passive promotion of the CONSORT checklist has not delivered the necessary improvements. Active engagement during the editorial process, training for editors and reviewers,

Conflict of interest

Andrew Jull was Handling Editor for the International Journal of Nursing Studies until 31 March 2014 and remains a member of the Editorial Advisory Board. Papers he handled as part of the editorial process may have been included in the trials published by the International Journal of Nursing Studies in 2012.

Contribution of the paper

AJ conceived the idea, both authors contributed to the data collection and analysis, PS drafted the paper, which AJ revised with additional analyses, and redrafted. Both authors have approved the final draft.

Acknowledgements

Phyue Sin Aye was the recipient of a University of Auckland Summer Scholarship awarded in order to conduct this study. The University of Auckland had no role in the design or conduct of this study.

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