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  • Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients

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EBM analysis
General medicine
Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients
  1. William Clark1,
  2. Paul Bird2,
  3. Terrence Diamond2,
  4. Peter Gonski3,
  5. Val Gebski4
  1. 1 Department of Interventional Radiology, St George Private Hospital, Sydney, New South Wales, Australia
  2. 2 Department of Medicine, St George and Sutherland Clinical school, Univsersity of New South Wales, Kogarah, New South Wales, Australia
  3. 3 Department of Aged Care, School of Public Health and Community Medicine, University of New South Wales, Randwick Campus, Randwick, New South Wales, Australia
  4. 4 Department of Biostatistics, Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to Dr William Clark, Interventional Radiology, St George Private Hospital, Sydney NSW2217, Australia; williamxrayclark{at}bigpond.com

Abstract

The Cochrane vertebroplasty review of April 2018 was replaced with an updated version in November 2018 to address complaints of errors in analysis. The updated version continues to misrepresent the evidence supporting early intervention with vertebroplasty for patients with uncontrolled, severe pain and fracture duration <6 weeks. The VAPOUR trial is the only blinded trial of vertebroplasty restricted to this patient group. It showed the benefit of vertebroplasty over placebo, particularly when the intervention occurred within 3 weeks of fracture. The Cochrane vertebroplasty review has ignored the positive outcomes in the VAPOUR trial. Open randomised trials of fractures <6-week duration support the positive findings of the VAPOUR trial. This is not described in the Cochrane review. The VAPOUR trial is clinically heterogeneous from other blinded trials. Cochrane protocol stipulates that clinically heterogeneous trials be described separately, as independent evidence, and not combined in analysis with dissimilar trials. Failure to observe this represents a serious protocol breach in the Cochrane review.

  • geriatric medicine
  • rheumatology
  • neurosurgery
  • back pain
  • interventional radiology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjebm-2019-111171

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    Footnotes

    • Contributors WC: wrote the first draft. PB: wrote the second draft. WC, PB, TD, PG and VG: contributed to the conception, drafting, critical revision and the final approval of the article.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. The VAPOUR trial, previously conducted by authors of this article, was funded by an unrestricted educational grant from CareFusion Corporation (San Diego, CA, USA). CareFusion Corporation had no role in the study design, data collection, data analysis, data interpretation, or writing of the report of the VAPOUR trial.

    • Competing interests WAC, PB, THD, PG and VG are authors of the VAPOUR trial. WAC was an investigator in Kallmes2009 and VERTOS4 trials. THD was an author in Kallmes 2009 trial. WAC, THD and PG were expert advisers to the Medicare Services Advisory Committee in application 1466 for Medicare funding of vertebroplasty in Australia.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.