Advertisement

In reply: When and how should we cluster and cross over: methodological and ethical issues (letters 1 and 2)

  • Cory E. Goldstein
  • Bruno Giraudeau
  • Charles Weijer
  • Monica Taljaard
Correspondence

Notes

Conflicts of interest

None declared.

Editorial responsibility

This submission was handled by Dr. Gregory L. Bryson, Deputy Editor-in-Chief, Canadian Journal of Anesthesia.

References

  1. 1.
    Spence J, Belley-Côté E, Lee SF, et al. The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial. Can J Anesth 2018; 65: 813-21.CrossRefGoogle Scholar
  2. 2.
    Goldstein CE, Giraudeau B, Weijer C, Taljaard M. When and how should we cluster and cross over: methodological and ethical issues. Can J Anesth 2018; 65: 760-5.CrossRefGoogle Scholar
  3. 3.
    Lee SF, Bangdiwala SI, Spence J, Connolly S. When and how should we cluster and cross over: methodological and ethical issues (letter 2). Can J Anesth 2018; 65: DOI:  https://doi.org/10.1007/s12630-018-1238-4
  4. 4.
    Spence J, Belley-Côté E, Ozchowski S, et al. When and how should we cluster and cross over: methodological and ethical issues (letter 1). Can J Anesth 2018; 65: DOI:  https://doi.org/10.1007/s12630-018-1237-5.
  5. 5.
    Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999; 318: 1407-9.CrossRefGoogle Scholar
  6. 6.
    Medical Research Council. Cluster randomised trials: methodological and ethical considerations. MRC clinical trial series - 2002. Available from URL: https://www.cebma.org/wp-content/uploads/Cluster-randomised-trials-Methodological-and-ethical-considerations.pdf (accessed September 2018).
  7. 7.
    Sim J, Dawson A. Informed consent and cluster-randomized trials. Am J Public Health 2012; 102: 480-5.CrossRefGoogle Scholar
  8. 8.
    Weijer C, Grimshaw JM, Eccles MP, et al. The Ottawa statement on the ethical design and conduct of cluster randomized trials. PLOS Med 2012; 9: e1001346.CrossRefGoogle Scholar
  9. 9.
    Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related research involving humans – Prepared by the Council for International Organizations of Medical Sciences (CIOMS) – In collaboration with the World Health Organization (WHO) – Geneva 2016. Available from URL: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf (accessed September 2018).
  10. 10.
    Canadian Institutes of Health Research; Natural Sciences and Engineering Research Council of Canada; Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans - 2014. Available from URL: http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf (accessed September 2018).
  11. 11.
    Office pour Human Research Protections. Code of Federal Regulations – Title 45 Public Welfare part 46 subpart A: basic HHS policy for protection of human research subjects 2009. Available from URL: https://www.hhs.gov/ohrp/sites/default/files/ohrp/humansubjects/regbook2013.pdf.pdf (accessed September 2018).
  12. 12.
    Gravenstein S, Davidson HE, Taljaard M, et al. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster randomised trial. Lancet Respir Med 2017; 5: 738-46.CrossRefGoogle Scholar

Copyright information

© Canadian Anesthesiologists' Society 2018

Authors and Affiliations

  • Cory E. Goldstein
    • 1
  • Bruno Giraudeau
    • 2
    • 3
  • Charles Weijer
    • 1
  • Monica Taljaard
    • 1
    • 4
    • 5
  1. 1.Rotman Institute of Philosophy, Western UniversityLondonCanada
  2. 2.Université de Tours, Université de Nantes, INSERM SPHEREToursFrance
  3. 3.INSERM CIC, CHRU de ToursToursFrance
  4. 4.Ottawa Hospital Research InstituteOttawaCanada
  5. 5.School of Epidemiology and Public HealthUniversity of OttawaOttawaCanada

Personalised recommendations