A Multi-Center Randomized Controlled Study Comparing Alternative

Antibiotic Regimens in Patients Undergoing Tumor Resections with

Endoprosthetic Replacements

November 01/2013

Investigators’ Meeting New York City

Trial Update

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

International PARITY Sites

Dec '12

Jan '13

Feb Mar Apr May Jun Jul Aug Sept Oct0

5

10

15

20

25

30

35

Cumulative Enrolment

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

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

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

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

Why We Collaborate?

Authorship Policy

Primary PaperWe will use group authorship for the

primarypublication:

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*

Primary PaperThe 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

Secondary PapersWe 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

PARITYInvestigators:

Minimal Important Differences of Functional Outcome Instruments in

Orthopaedic OncologyEvaniew N, Ghert M, Bhandari M, and Guyatt G

on behalf of The PARITY Investigators*

Successful Site Strategies

Hospital Maisonneuve Rosemont Montreal, Quebec

• Patient’s Consent

• Nursing collaboration

• Bumps along the road with pharmacy

• Anecdotes

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

Mount Sinai HospitalToronto, Ontario

• ‘Wine and Dine’ your pharmacists

• Communication with residents and in- patient nursing staff

• The vagaries of tumor surgery

MID SubstudyMinimal Important Differences of

Functional Outcome Instruments in Orthopaedic Oncology

Nathan Evaniew, Michelle Ghert, Mohit Bhandari, Gordon Guyatt, on behalf of The PARITY Investigators*

Effect Size Zero MID Large

Greater than MID

Equivalent to MID

Statistically significant

Not statistically significant

Minimum Important Differences

Validity Reliability MID

MSTS 1993 Yes Yes ??

TESS Yes Yes ??

SMFA* Yes Yes ??

Functional Outcomes

MSTS – 1993MSTS – 1987

TESS

_____________Baseline(6 weeks)3 months6 months

12 months

MSTS – 1993

TESSSMFAGRC

_____________Baseline6 weeks3 months6 months

12 months

Protocol Amendments (pending)

MID SubstudyWhy?

• Patient-important outcomes

• Rational outcome reporting

• Sample size calculations

Status?• Steering committee-

approved • Independent funding

received

Website Launch

www.paritytrial.com