Ethics Approval and Consent to Participate
This study received ethics approval vis Clinical Trials Ontario (CTO)(#2029) with the Hamilton Integrated Research Ethics Board (HiREB) as the Research Ethics Board (REB) of Record. Written, informed consent to participate will be obtained from all participants.
Consent for Publication
Not Applicable.
Availability of Data and Materials
The Principal Investigators and research personnel from the McMaster Methods Centre will have access to the final trial dataset. This data may also be used for secondary publications, with permission from the Principal Investigators.
Competing Interests
JWB is funded, in part, by a CIHR Canada Research Chair in the prevention and development of chronic pain.
Funding
The COPE trial is funded by the Canadian Institutes of Health Research (CIHR) (Project Grant: 156730), and the Orthopaedic Trauma Association (OTA). The Michael G. DeGroote Institute for Pain Research & Care at McMaster University funded start-up activities at the Methods Centre. The funding sources did not influence the design or conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Authors’ Contributions
JWB and SS are the co-Principal Investigators, who conceived the study and led protocol development. GD, PM, REM, MN, and MB contributed to the design and development of the protocol and manuscript. LT is the lead trial statistician. All authors read, revised, and approved the final manuscript.
Acknowledgements
*The COPE Investigators
Writing Committee: The following are responsible for the development, writing, and review of the COPE protocol: Jason W. Busse (Co-Chair, McMaster University, Hamilton, ON), Sheila Sprague (Co-Chair, McMaster University, Hamilton, ON), Gina Del Fabbro (McMaster University, Hamilton, ON), Paula McKay (McMaster University, Hamilton, ON), Lehana Thabane (McMaster University, Hamilton, ON), Randi E. McCabe (McMaster University, Hamilton, ON), Matilda Nowakowski (McMaster University, Hamilton, ON), Christy Shibu (McMaster University, Hamilton, ON), Natalie Fleming (McMaster University, Hamilton, ON), Herman Johal (McMaster University, Hamilton, ON), Gerard Slobogean (University of Maryland School of Medicine, Baltimore, MD), Roman M. Natoli (Indiana University, Indianapolis, IL) I. Leah Gitajn (Dartmouth-Hitchcock Medical Center, Lebanon, NH) Prism Schneider (University of Calgary, Calgary, AB), PJ Devereaux (McMaster University, Hamilton, ON), Emil H. Schemitsch (University of Western Ontario, London, ON), Mohit Bhandari (McMaster University, Hamilton, ON).
Steering Committee: Jason W. Busse (Principal Investigator, McMaster University, Hamilton, ON), Sheila Sprague (Principal Investigator, McMaster University, Hamilton, ON), Mohit Bhandari (McMaster University, Hamilton, ON), Gerard Slobogean (University of Maryland School of Medicine, Baltimore, MD), Lehana Thabane (McMaster University, Hamilton, ON), Randi E. McCabe (McMaster University, Hamilton, ON), Emil H. Schemitsch (University of Western Ontario, London, ON).
Research Methodology Advisory Core: Gordon H. Guyatt (McMaster University, Hamilton, ON), PJ Devereaux (McMaster University, Hamilton, ON), Lehana Thabane (McMaster University, Hamilton, ON), Mohit Bhandari (McMaster University, Hamilton, ON).
Orthopaedic Surgery Advisory Core: I. Leah Gitajn (Dartmouth University, Hanover, NH), Gerard Slobogean (University of Maryland School of Medicine, Baltimore, MD), Emil H. Schemitsch (University of Western Ontario, London, ON).
Psychology Advisory Core: Randi E. McCabe (McMaster University, Hamilton, ON), Matilda Nowakowski (St. Joseph’s Healthcare, Hamilton, ON), Eleni Hapidou (McMaster University, Hamilton, ON), Delia Chiaramonte (Greater Baltimore Medical Center, Baltimore, MD).
Medical/Pain Advisory Core: Henrick Kehlet (Copenhagen University, Denmark), James Khan (University of Toronto, Toronto, ON).
Adjudication Committee: Matilda Nowakowski (St. Joseph’s Healthcare, Hamilton, ON), Aaron Johnson (University of Maryland, Baltimore, MD).
Methods Centre, McMaster University, Hamilton, ON: Paula McKay, Gina Del Fabbro, Natalie Fleming, Christy Shibu, Diane Heels-Ansdell, Sofia Bzovsky.
Participating Centres:
Hamilton Health Sciences - General Site, Hamilton, ON: Brad A. Petrisor, Dale Williams, Bill Ristevski, Jamal Al-Asiri, Herman Johal, Matthew Denkers, Kris Rajaratnam, Jodi L. Gallant, Sarah MacRae, Kaitlyn Pusztai, Sara Renaud, Nicki Johal.
The Ottawa Hospital, Ottawa, ON: Steven Papp, Karl-Andre Lalonde, Bradley Meulenkamp, Allan Liew, Manisha Mistry, Braden Gammon, Wade Gofton, Geoffrey Wilkin, Melanie Dodd-Moher.
Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON: David Puskas, Travis Marion, Tina Lefrancois, Jubin Payandeh, Claude Cullinan, Tracy Wilson, Kurt Droll, Michael Riediger, Rabail Siddiqui, Shalyn Littlefield, Simrun Chahal, Paige Wagar.
Foothills Medical Centre, University of Calgary, Calgary, AB: Prism S. Schneider, Tosin Ogunleye, Tanya Cherppukaran, Karin Lienhard.
Memorial University, St. John’s, NFLD: Nicholas Smith, Sarah Anthony, Krista Butt.
University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore, MD: Gerard Slobogean, LaShann Selby, Murali Kovvur, Joshua Lawrence, Skyler Sampson, Kristin Turner.
University of Maryland Capital Region Health, Baltimore, MD: Todd Jaeblon, Haley K. Demyanovich, Sneh Talwar, Caroline Benzel.
Dartmouth-Hitchcock Medical Center, Lebanon, NH: I. Leah Gitajn, Theresa Chockbengboun, Devin Mullin, Logan Bateman, Melanie Christian, Peter DePalo.
Beth Israel Deaconess Medical Center, Boston, MA: Paul J. Appleton, John J. Wixted, Edward K. Rodriguez, Michael F. McTague, Katiri Wagner, Kristina Brackpool, Kate Hegermiller, Nhi Nguyen.
Indiana University School of Medicine, Indianapolis, IN: Roman M. Natoli, Courteney Fentz, Maricela Diaz, Jill Niceley.
Prisma Health – Upstate, Greenville, SC: Kyle J. Jeray, Thomas M. Schaller, Michael S. Sridhar, John D. Adams, Richard W. Gurich Jr., Stephanie L. Tanner, Kyle Adams, Michelle Donohue, Emily Bray, Calleigh Brignull, Harper Sprouse.