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Protocol for a systematic scoping review of reasons given to justify the performance of randomised controlled trials
  1. Brian Dewar1,
  2. Mark Fedyk2,
  3. Lucas Jurkovic1,
  4. Stephanie Chevrier1,
  5. Rosendo Rodriguez3,
  6. Simon C Kitto4,
  7. Raphael Saginur1,
  8. Michel Shamy1
  1. 1Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  2. 2Philosophy, Faculty of Arts, Mount Allison University, Sackville, New Brunswick, Canada
  3. 3Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  4. 4Innovation in Medical Education, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  1. Correspondence to Dr Michel Shamy; mshamy{at}toh.ca

Abstract

Introduction Randomised controlled trials (RCTs) are widely viewed to generate the most reliable medical knowledge. However, RCTs are not always scientifically necessary and therefore not always ethical. Unfortunately, it is not clear when an RCT is not necessary or how this should be established. This study seeks to systematically catalogue justifications offered throughout the medical and ethics literature for performing randomisation within clinical trials.

Methods and analysis We will systematically search electronic databases of the medical literature including MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov; databases of philosophical literature including Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE, National Reference Centre for Bioethics; the library catalogue at the University of Ottawa; bibliographies of retrieved papers; and the grey literature. We will also pursue suggestions from experts in the fields of medical ethics, philosophy and clinical trial methodology. Article screening, selection and data extraction will be performed by two independent reviewers based on prespecified inclusion/exclusion criteria. A third reviewer will be consulted to resolve any discrepancies. We will then extract the reasons given to justify randomisation using methodology established to extract data in a defensible, systematic manner. We will track the reasons given, their frequency of use and changes over time. Finally, using grounded theory, we will combine the reasons into broader themes. These themes will form the foundation of our subsequent analysis from qualitative and quantitative perspectives. This review will map existing arguments that clinicians, ethicists and philosophers use to ethically justify randomisation in clinical trials.

Ethics and dissemination No research ethics board approval is necessary because we are not examining patient-level data. This protocol complies with the reported guidance for conducting systematic scoping reviews. The findings of this paper will be disseminated via presentations and academic publication. In a subsequent phase of this research, we hope to engage with stakeholders and translate any recommendations derived from our findings into operational guidelines.

  • medical ethics
  • clinical trials
  • ethics (see medical ethics)
  • systematic scoping review

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors MS is the guarantor of the review. MS conceived of the presented idea. MS, BD, MF, LJ and SC assisted in research design. RR, SK and RS assisted in verifying analytical methods. MS provided supervision of the design process.

  • Funding This work was supported by the Canadian Institutes for Health Research Catalyst Grant in Ethics, grant number 385778. It was also supported by a grant from the University Medical Research Fund, Department of Medicine, University of Ottawa.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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