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Translating Evidence into Practice
Professor John R Zalcberg
Head of Cancer Research Program
School of Public Health and Preventive Medicine
DEFINE
2014 2015 2016 2017 2018 2019 2020
USA TRIAL
TRIAL ANALYSED ABSTRACT PUBLISHED
GUIDELINES
AUSTRALIAN PRACTICE
EVIDENCERADAR CHANGE
Why do trials here?
DEFINE
2014 2015 2016 2017 2018
AUSTRALIAN TRIAL
TRIAL ANALYSED ABSTRACT PUBLISHED
AUSTRALIAN PRACTICE
CHANGERESULTS
Why do trials here?
DEFINE TRIAL
Topgear trial
ECC x3
ECC x2
Sx
Chemo/XRT
ECC x3
ECC x3Sx
Randomise
XRT = radiation therapy
Sx = surgery
Chemo
Chemo
Chemo
Chemo
Hypothesis
• Participation and conduct of a clinical trial
changes clinical practice independently of any
new finding that may result from the trial.
Osteoporotic vertebral fractures
• 1 in 4 women and 1 in 5 men > 50 yrs
• 50,000 new cases/year in Australia (700,000 US)
• ⅓ to ½ will result in severe pain & disability
• generally heal within a few weeks or months
• no effective treatments currently available
• high risk of further vertebral fracture within a year
– untreated osteoporosis, single VF ~ 20% risk (1 in 5)*
– treated with bisphosphonates ~ 10% risk (1 in 10)
*Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA 2001;285:320-3.
Vertebroplasty
Bone cement (e.g. poly methylmethacrylate) injected into fracture under radiological guidance
Dramatic increase in vertebroplasties
Gray D, Hollingworth W, Onwudiwe N, Deyo R, Jarvik J. Thoracic and lumbar vertebroplasties performed in US Medicare enrollees, 2001-2005. JAMA. 2007;298(15):1760-2.
Lad S, Patil C, Lad E, Hayden M, Boakye M. National trends in vertebral augmentation procedures for the treatment of vertebral compression fractures. Surgical Neurology. 2008
Gray et al Spine 2008. Nation-wide and State-specific primary vertebroplastyrates per 100,000 Part B fee-for-service
PUBLISHED : 14 OCTOBER 2004 | THE
AUSTRALIAN FINANCIAL REVIEW | JILL MARGO
“Every now and then a treatment comes along that delivers almost miraculous results in properly selected patients. This is now happening with a treatment for a particular form of back pain that is caused by osteoporosis…”
Pre- and post-Vertebroplasty pain scores (30 uncontrolled studies, 7 prospective)
Hochmuth K, et al. Eur Rad 2006;16: 998-1004.
Pre: Mean 8.1 (6.4 to 9.7)
Post: Mean 2.6 (1.7 to 3.9)
Amount injected not describedSerious complications < 1% (23 studies)
Bone cement leakage 41.2%
(7 to 81%) (20 studies) but >98% asymptomatic
One or more possible explanations
OR
• Natural history
• Biased assessment of outcome (e.g., high
by doc. and patient)
• Placebo response
• Vertebroplasty is highly effective
Randomised, stratified by• centre (x 4)• gender • duration of symptoms (< or ≥ 6 weeks)
Either vertebroplasty or sham procedure
Participants, outcome assessors, investigators (except treating radiologist) all blinded to treatment allocation
Design
Results
No important baseline differences between groups
Participants in both groups improved to amodest degree
No evidence of a beneficial effect of vertebroplasty over sham treatment for painful vertebral fractures at 1 week, 1, 3 or 6 months
“….How do these morons get this published? Buchbinder is a socialist charlatan.
She is better suited to practice medicine in China or Cuba - unfortunately they
probably wouldn't give her a license in either of those countries….”
“I can only hope that one or both of them actually will suffer from a fracture of this
type and are denied this valuable tool to relieve the pain and prevent further
deformity. It appears that would be the only event that would stop them on their
highly focused mission of eliminating these procedures altogether.”
An example of the types of emails I receive
Some changes…
• Withdrawal of reimbursement– Blue Cross Blue Shield, USA – Ontario HTAC, Canada– Australia MSAC, Nov 1, 2011
• Guidelines– American Academy Orthopaedic Surgeons
(AAOS) strong recommendation against its use, Sept 2010
Recommendation 8We recommend against vertebroplasty for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.Strength of Recommendation: Strong
PRESS RELEASE“By making a strong recommendation against the use of vertebroplasty, the group is expressing its confidence that future evidence is unlikely to overturn the results of these trials [i.e., the sham controlled trials].”
When experience clashes with evidence
PUBLISHED : 13 MAY 2010 | THE AUSTRALIAN FINANCIAL REVIEW | JILL MARGO
Many treatments are introduced into medical practice prematurely, before they
have been scientifically evaluated.
Two studies have turned vertebroplasty (VP) on its head.
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