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Differences in methodological quality between positive and negative published clinical trials

Authors

  • Noelle M. Chiavetta EdM,

    Research Coordinator
    1. Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Boston, Massachusetts, USA
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  • Ana R.S. Martins RN,

    Research Program Coordinator
    1. Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Boston, Massachusetts, USA
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  • Inês C.R. Henriques RN,

    Study Nurse
    1. Faculty of Medicine of the University of Coimbra, Coimbra, Portugal
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  • Felipe Fregni MD PhD MPH

    Associate Professor, Corresponding author
    1. Harvard Medical School Director, Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital Director, Principles and Practice of Clinical Research, Harvard Medical School, Boston, Massachusetts, USA
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  • Equally contributing authors.

Abstract

Aim

Comparison of methodological quality differences in nursing clinical trials with positive and negative findings.

Background

The growth of nursing publications and increased reliance on data to guide clinical care make publication quality assessment imperative. One major concern is the tendency for more studies with positive findings to be published, potentially resulting in the publication of lower quality trials.

Design

Secondary analysis of published trials to compare studies with positive and negative findings in terms of clinical trial quality and sample size calculation methodology.

Data Sources

Twenty articles each from three major nursing journals (Journal of Clinical Nursing, Journal of Advanced Nursing and International Journal of Nursing Studies) for the years 2010–2012. We assessed article quality in terms of Jadad scores, methods and total sample size.

Implications for Nursing

This article underscores the importance of nurses and nursing students having the ability to assess the quality of published trials, so that they can make appropriate judgments on the implementation of care for patients as the use of evidence-based practice increases.

Conclusion

Potential differences in methodological quality between positive and negative trials may lead to positive trials with biased results, or discrimination against negative trials. The CONSORT is recommended, but use is still limited. Therefore, it is important to reinforce the use of these guidelines to supply readers with information on the quality of the published trials. The combination of authors publishing higher quality trials and deeper reader knowledge of quality assessment can have important clinical consequences.

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