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Patient involvement...or not? Analysis of 'Patient Involvement' statements in clinical trial publications in The BMJ

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posted on 12.06.2018, 15:22 by Anne Clare Wadsworth, Lauri ArnsteinLauri Arnstein, Thomas Gegeny, Rachel JonesRachel Jones, Arabella Sargent, Antonio Ciaglia, Richard Stephens, Beverley Yamamoto, Karen L. Woolley


In 2014, The BMJ introduced a mandatory ‘Patient Involvement’statement in the Methods section of research articles. We investigated the extent of patient involvement described in clinical trial research publications in The BMJ. Our primary objective was to quantify patient authorship.

Research design and methods

We searched PubMed (journal: The BMJ; publication type: clinical trial; dates: 2015/01/01-2016/12/31) and electronically exported all retrieved articles. Non-research articles were removed. Two authors categorised patient involvement based on the verbatim ‘Patient Involvement’ and Acknowledgements sections in each publication. Results were cross-checked.


Of the 62 articles retrieved, 10 were non-research articles. Reported patient involvement was generally low. Involvement was lowest for authorship (1.9%; 1/52) and highest for thanking patients for their participation (57.7%; 30/52).


Despite The BMJ’s requirement, reported patient involvement in clinical trial publications remains low. Patient authorship is being encouraged, but remains rare. Advocacy efforts for meaningful patient involvement during research, including publication planning and preparation, must continue.


Envision Pharma Group provided limited financial support for administrative expenses.