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Surgery
Protocol
Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study
  1. Michael H McGillion1,2,
  2. Shaunattonie Henry1,2,
  3. Jason W Busse3,4,
  4. Carley Ouellette1,2,
  5. Joel Katz5,
  6. Manon Choinière6,
  7. Andre Lamy2,4,
  8. Richard Whitlock2,4,
  9. Shirley Pettit2,
  10. Jacqueline Hare2,
  11. Krysten Gregus2,
  12. Katheryn Brady2,
  13. Nazari Dvirnik2,4,
  14. Stephen Su Yang2,4,
  15. Joel Parlow7,
  16. Deborah Dumerton-Shore8,
  17. Ian Gilron7,
  18. D Norman Buckley3,
  19. Harsha Shanthanna3,
  20. Sandra L Carroll1,
  21. Peter C Coyte9,
  22. Shanil Ebrahim4,
  23. Wanrudee Isaranuwatchai9,
  24. Denise N Guerriere9,
  25. Jeffrey Hoch10,
  26. James Khan3,
  27. Joy MacDermid11,
  28. Geraldine Martorella12,
  29. J Charles Victor9,
  30. Judy Watt-Watson13,
  31. Kimberly Howard-Quijano14,
  32. Aman Mahajan14,
  33. Matthew T V Chan15,
  34. Hance Clarke16,
  35. P J Devereaux2,4
  1. 1 School of Nursing, McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada
  2. 2 Anesthesiology, Perioperative Medicine and Surgical Research Unit, Population Health Research Institute, Hamilton, Ontario, Canada
  3. 3 Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
  4. 4 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
  5. 5 Department of Psychology, York University, Toronto, Ontario, Canada
  6. 6 Centre de recherche de Centre hospitalier de l’Université de Montreal, Montreal, Quebec, Canada
  7. 7 Department of Anesthesiology and Perioperative Medicine, Queen’s University, Kingston, Ontario, Canada
  8. 8 Department of Anesthesiology, Kingston General Hospital, Kingston, Ontario, Canada
  9. 9 Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
  10. 10 Department of Public Health Sciences, University of California, Davis, Davis, California, USA
  11. 11 School of Physical Therapy, Western University, London, Ontario, Canada
  12. 12 College of Nursing, Florida State University, Tallahassee, Florida, USA
  13. 13 Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada
  14. 14 Department of Anesthesiology, David Geffen School of Medicine at University of California, Los Angeles, California, USA
  15. 15 Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, Hong Kong
  16. 16 Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Dr Michael H McGillion; mmcgill{at}mcmaster.ca

Abstract

Introduction Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not.

Methods and analyses In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score.

Ethics and dissemination This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals.

Trial registration number NCT01842568.

  • pain management
  • cardiac surgery
  • health economics

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/.

https://doi.org/10.1136/bmjopen-2018-022995

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    Footnotes

    • Contributors MHM, PJD, JWB, JCV, JKa, AL, RW, SP, HC, SLC, ND, HS and DNB contributed to the conception and design of the study. KB, JH, KG, DD-S and SH contribute to the acquisition of data; data analyses and interpretation will be conducted by MHM, JWB, PJD, SH, CO, PCC, SE, DNG, JH, WI, JKa, SI, JM, HC, GM, JCV, SSY, JP, IG, MTVC, MC, JW-W, KH-Q, AM. MHM, JB, JKh and PJD wrote the first draft of the protocol. JCV, JKa, AL, MC, RW, SP, KB, HS and JW-W revised the protocol critically for important intellectual content. All authors have read and approved the final version of the manuscript to be published. The authors wish to thank our patient advisors for their testimonials, which served to establish the need for this study.

    • Funding This work is supported with funding from the Canadian Institutes of Health Research, #MOP–133714, The Hamilton Academic Health Sciences Organization, and the General Research Fund 14101414, Research Grant Council, Hong Kong SAR.

    • Competing interests M­­­­HM and PJD are members of a research group with a policy of not accepting honorariums or other payments from industry for their own personal financial gain. They do accept honorariums/payments from industry to support research endeavours and costs to participate in meetings. Based on study questions, PJD has originated and grants he has written, he has received grants from Abbott Diagnostics, Boehringer Ingelheim, Covidien, Octapharma, Philips Healthcare, Roche Diagnostics and Stryker. PJD has participated in an consultancy advisory board meeting for Boehringer Ingelheim.

    • Patient consent Obtained.

    • Ethics approval This protocol has been approved by the responsible bodies at each of the hospital sites. Hamilton Integrated Research Ethics Board.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.