Two new studies calling into question the effectiveness of a common surgical procedure highlight the value of comparative effectiveness research, writes James N. Weinstein, DO, MS, in the 6 August edition of the New England Journal of Medicine.
Vertebroplasty is a surgical procedure in which bone cement is injected into a fractured vertebra to stabilise the spine and reduce pain from the fracture. Rates of the procedure have doubled from 4.3 to 8.9 per 1,000 persons in the past six years. Direct costs related to treating the fractures, which are most commonly associated with osteoporosis, were estimated to range from US$12 to 18 billion in 2002. Yet two new studies, also appearing in NEJM, conclude that there is no significant benefit from the surgery, when compared to sham treatment.
In his editorial,"Balancing Science and Informed Choice in Decisions About Vertebroplasty", Weinstein writes that these findings "may change vertebroplasty from a procedure that is virtually always considered to be successful to one that is considered no better than placebo."
Weinstein is Director of the Dartmouth Institute for Health Policy and Clinical Practice and Chairman of the Departments of Orthopaedic Surgery at Dartmouth-Hitchcock Medical Center (DHMC) and Dartmouth Medical School (DMS). He said the new findings make a powerful case for comparative effectiveness research of the kind that has been recommended as part of comprehensive health reform.
"Approximately 40,000 of these procedures are performed each year," said Weinstein. "Until now, we had no evidence showing whether they worked. With the publication of these two studies, we can see that in fact, the procedure is not effective for our patients."
Although reducing the number of vertebroplasties performed would have a significant impact on health care costs, Weinstein said that is not the most important result of the study. "Human cost is always the most critical factor. This shows us those patients may be having surgical interventions that are no better than placebo," he said. "Any operation carries with it risks, including infection, unintended injury, and adverse reaction to associated medications. It’s important in each case to ask if the benefits outweigh the risks. In this case, I believe we can say that they do not."
Weinstein leads the national SPORT study, now in its 11th year. It is the largest and most comprehensive to compare the effectiveness of the three most common conditions for which back surgery is performed. Weinstein said the NIH-funded SPORT and clinical trials such as
those reported in NEJM, show the importance of continuing to fund major comparative effectiveness studies, to provide best evidence to patients and physicians so they can weigh the risks and benefits of a treatment or intervention.
"Americans prize advances in technology. However if in major medical challenges … the alternative is to pay the cost of perpetual uncertainty, we need to support the research necessary to provide sufficient efficacy and safety information for patients to make truly informed choices," said Weinstein.
(Source: Dartmouth-Hitchcock Medical Center: New England Journal of Medicine: August 2009)