A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resect

1. A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements Investigators’ Meeting New York City November 01/2013

2. Trial Update

3. Current Funding • Orthopaedic Research & Education Foundation: • OREF/MSTS Clinical Research Grant in Orthopaedic Oncology • Physicians’ Services Incorporated Foundation (Ontario, Canada) • Canadian Cancer Society Research Institute (CCSRI) • Private Donation: We would like to thank the Dacol-Manherz family for their generous donation to the PARITY study

4. International PARITY Sites

6. PARITY sites actively enrolling • Juravinski Hospital and Cancer Center, Hamilton, ON, Canada • Mt. Sinai Hospital, Toronto, ON, Canada • McGill University Health Centre, Montreal QC, Canada • Montreal Maisonneuve Rosemont, Montreal QC, Canada • Vancouver General Hospital, Vancouver, BC, Canada • Ottawa General Hospital, Ottawa, ON, Canada • Vanderbilt Medical Center, Nashville, TN, USA • Huntsman Cancer Institute, Salt Lake City, UT, USA • Boston Children’s Hospital, Boston, MA, USA • Beth Israel Deaconess Medical Center, Boston, MA, USA

7. PARITY sites in active start-up • *Saint-Francois d’Assisse et L’Hotel Dieu de Quebec City, QC, Canada* • *Hospital Universitario Austral, Bueons Aires, Argentina* • *Memorial Sloan-Kettering Cancer Center, New York, NY, USA* • University of Minnesota, Minneapolis, MN, USA • Holden Comprehensive Cancer Center, Iowa City, IO, USA • Wexner Medical Center, Columbus, OH, USA • Rothman Institute, Philadelphia, PA, USA • University of Connecticut Health Center, Farmington, CT, USA • Emery University, Atlanta, GA, USA • Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK • All India Institute of Medical Sciences, New Delhi, India • Royal Adelaide Hospital, Adelaide, Australia • Sinai Hospital of Baltimore, University of Maryland, Baltimore, MD, USA • University of Southern California, Los Angeles, CA, USA • Loyola University Medical Center, Chicago, IL, USA • Oregon Health and Science University, Portland, OR, USA • University Hospital of Tampere, Tampere, Finland

8. PARITY sites with expressed interest • University of Calgary, Calgary, AB, Canada • Albany Medical Center, Albany, NY, USA • Marshall University, Huntington, WV, USA • University of Washington, Seattle, WA, USA • Menorah Medical Center and Mid-American Sarcoma Institute, University of Kansas, KS, USA • University of Colorado School of Medicine, Denver, CO, USA • University of Pittsburgh, Pittsburgh, PA, USA • Maimonides Medical Center, Brooklyn, NY, USA • University of Rochester, Rochester NY, USA • Medical College of Wisconsin, WI, USA • SUNY Upstate University Hospital, Syracuse, NY, USA

9. PARITY sites with expressed interest • Royal National Orthopaedic Hospital Trust, Stanmore, England • The Robert Jones Agnes Hospital NHS Foundation Trust, Oswestry, Wales • Oxford University Hospital NHS Trust, Oxford, England • The Newcastle Upon Tyne Hospital NHS Foundation Trust • Royal lnfirmary of Edinburgh, Edinburgh, Scotland • Nuffield Health Glasgow Hospital, Glasgow, Scotland • Middlemore Hospital, Papatoetoe, NZ • Tel Aviv Medical Center, Tel Aviv, Israel • University of Sao Paulo, Sao Paulo, Brazil • Grey’s Hospital, University of KwZulu-Natal, Durban, South Africa • Hospital Universtario del Valle, Cali, Columbia • University Hospital Copenhagen, Copenhagen, Denmark

10. Why We Collaborate?

11. Authorship Policy

12. Primary Paper We will use group authorship for the primary publication: Prophylactic Antibiotic Regimens In Tumor SurgerY (PARITY): A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements The PARITY Investigators*

13. Primary Paper The authorship appendix will acknowledge the: • Writing Committee Members • Methods Centre Personnel • Steering Committee Members • Central Adjudication Committee Members • Data Safety and Monitoring Board Members • Clinical Site Personnel • Site Principal Investigator • Site Co-Investigators • Participating Surgeons • Site Coordinators

14. Secondary Papers We will credit authorship to the individual co- investigators who write the secondary and sub- study manuscripts, with acknowledgement to the rest of the group i.e., on behalf of the PARITY Investigators: Minimal Important Differences of Functional Outcome Instruments in Orthopaedic Oncology Evaniew N, Ghert M, Bhandari M, and Guyatt G on behalf of The PARITY Investigators*

16. Successful Site Strategies

17. Hospital Maisonneuve Rosemont Montreal, Quebec • Patient’s Consent • Nursing collaboration • Bumps along the road with pharmacy • Anecdotes

18. The Royal Orthopaedic NHS Foundation Trust, Birmingham, UK • Issue with Antibiotic • Sourcing Antibiotic for the trial using aseptic conditions • Amending the protocol • Cefuroxime info • Inclusion/Exclusion criteria • Dosages for pediatric patients

19. Mount Sinai HospitalToronto, Ontario • ‘Wine and Dine’ your pharmacists • Communication with residents and in- patient nursing staff • The vagaries of tumor surgery

20. MID Substudy Minimal Important Differences of Functional Outcome Instruments in Orthopaedic Oncology Nathan Evaniew, Michelle Ghert, Mohit Bhandari, Gordon Guyatt, on behalf of The PARITY Investigators*

21. Minimum Important Differences Greater than MID Equivalent to MID Statistically significant Not statistically significant Zero MID Large Effect Size

22. Functional Outcomes

23. Protocol Amendments (pending) MSTS – 1993 MSTS – 1987 TESS _____________ Baseline (6 weeks) 3 months 6 months 12 months MSTS – 1993 TESS SMFA GRC _____________ Baseline 6 weeks 3 months 6 months 12 months

24. MID Substudy • Why? • Patient-important outcomes • Rational outcome reporting • Sample size calculations • Status? • Steering committee-approved • Independent funding received

25. Website Launch • www.paritytrial.com