Transcript A Multi-Center Randomized Controlled Study Comparing

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
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
Cumulative Enrolment
35
30
25
20
15
10
5
0
Dec Jan Feb Mar Apr May Jun
'12 '13
Jul
Aug Sept Oct
PARITY sites actively enrolling
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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
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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 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*
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
Secondary Papers
We will credit authorship to the individual coinvestigators who write the secondary and substudy 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*
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 Hospital
Toronto, Ontario
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‘Wine and Dine’ your pharmacists
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Communication with residents and inpatient nursing staff
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The vagaries of tumor surgery
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*
Minimum Important Differences
Greater than MID
Equivalent to MID
Statistically significant
Not statistically significant
Zero
MID
Large
Effect Size
Functional Outcomes
Validity
Reliability
MID
MSTS 1993
Yes
Yes
??
TESS
Yes
Yes
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SMFA*
Yes
Yes
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Protocol Amendments (pending)
MSTS – 1993
MSTS – 1987
TESS
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Baseline
(6 weeks)
3 months
6 months
12 months
MSTS – 1993
TESS
SMFA
GRC
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Baseline
6 weeks
3 months
6 months
12 months
MID Substudy
Why?
• Patient-important outcomes
• Rational outcome reporting
• Sample size calculations
Status?
• Steering committee-approved
• Independent funding received
Website
Launch
www.paritytrial.com