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Techniques and Methods

Mind your methods: obesity trials and the consort guidelines

International Journal of Obesity volume 43, pages 1493–1496 (2019)Cite this article

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Last year, a nutrition scientist at a prestigious American university was charged with academic misconduct owing to the use of flawed research methods [1]. One of the methods that led to the misconduct charge was “P-hacking”, defined by Simonsohn et al. [2] as conducting multiple analyses but only revealing the results with P values < 0.05. Thus, P-hacking is “data dredging” or a “fishing expedition” followed by selective reporting, with P values singled out as the driver of the selection process. Selective reporting can lead to a type of publication bias that can result in false-positive findings that are unable to be replicated.

In an effort to reduce this and other types of bias, in 1996 a group of experts that included medical journal editors, clinical trialists, epidemiologists, and statisticians published the Consolidated Standards of Reporting Trials (CONSORT) statement [3] with the goal of encouraging complete and transparent reporting of trial data. The original statement was followed by revisions with checklists [4, 5] and two publications that more fully explained the rationale behind the guidance [6, 7]. Since then, > 20 extension papers have been published that address specific types of trials. In 2018 over 600 journals endorsed the CONSORT guidelines, typically in the form of a supportive statement in the Instructions to Authors [8]. Some journals require submission of the CONSORT checklist [4] prior to publication. This checklist explicitly queries 37 points (numbered as 25 items), and the authors must list the page of the manuscript where each point is addressed. Thus, the checklist provides a detailed, concrete tool to guide the reporting of randomized trials. Nevertheless, a gap remains between theoretical guidelines and actual practice.

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Acknowledgements

I thank Charles Poole, Kimberly P. Truesdale, Madison N. LeCroy, and Joana Araújo for helpful comments and suggestions. This work was supported by awards U01 HL103561 and U01 HD 068890 from the National Heart, Lung, And Blood Institute, the Eunice Kennedy Shriver National Institute of Child Health and Development, and the Office of Behavioral and Social Sciences Research. The content expressed in this paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, And Blood Institute, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, or the US Department of Health and Human Services.

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  1. Departments of Nutrition and Epidemiology, CB 7400, University of North Carolina, Chapel Hill, NC, USA

    June Stevens

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Correspondence to June Stevens.

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Dr. Stevens has been funded by an NIH grant HL103561 from the Office of Behavioral and Social Sciences Research, National Institutes of Health. Dr. Stevens receives funding as a co-investigator for a study funded by WW (formerly known as Weight Watchers).

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Stevens, J. Mind your methods: obesity trials and the consort guidelines. Int J Obes 43, 1493–1496 (2019). https://doi.org/10.1038/s41366-019-0369-1

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