Translating Evidence into Practice

Transcription

1 Translating Evidence into Practice Professor John R Zalcberg Head of Cancer Research Program School of Public Health and Preventive Medicine

2 USA TRIAL Why do trials here? DEFINE TRIAL ANALYSED ABSTRACT PUBLISHED RADAR EVIDENCE GUIDELINES CHANGE AUSTRALIAN PRACTICE AUSTRALIAN TRIAL Why do trials here? DEFINE TRIAL ANALYSED ABSTRACT PUBLISHED DEFINE TRIAL RESULTS CHANGE AUSTRALIAN PRACTICE

3 Topgear trial R a n d o m i s e Chemo ECC x3 Chemo ECC x2 Chemo/XRT Sx Sx Chemo ECC x3 Chemo ECC x3 XRT = radiation therapy Sx= surgery

4 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.

5 Vertebroplasty Bone cement (e.g. poly methylmethacrylate) injected into fracture under radiological guidance Dramatic increase in vertebroplasties Gray et al Spine Nation-wide and State-specific primary vertebroplasty rates per 100,000 Part B fee-for-service Gray D, Hollingworth W, Onwudiwe N, Deyo R, Jarvik J. Thoracic and lumbar vertebroplasties performed in US Medicare enrollees, JAMA. 2007;298(15): 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

6 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) Amount injected not described Serious complications < 1% (23 studies) Bone cement leakage 41.2% (7 to 81%) (20 studies) but >98% asymptomatic Pre: Mean 8.1 (6.4 to 9.7) Post: Mean 2.6 (1.7 to 3.9) Hochmuth K, et al. Eur Rad 2006;16:

7 One or more possible explanations Vertebroplasty is highly effective OR Natural history Biased assessment of outcome (e.g., high by doc. and patient) Placebo response Design 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

8 Results No important baseline differences between groups Participants in both groups improved to a modest degree No evidence of a beneficial effect of vertebroplasty over sham treatment for painful vertebral fractures at 1 week, 1, 3 or 6 months

9 An example of the types of s I receive.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.

10 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

11 Recommendation 8 We 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.