JBJS: U.K. NICE Guidelines Have "Little Impact" on Surgeons' Product Selection
BY LAUREN UZDIENSKI, SEPTEMBER 10, 2007
The July U.K. edition of JBJS reported results of a study evaluating the impact of the U.K.'s National Institute for Health and Clinical Excellence (NICE) guidelines for hip replacements. NICE publishes guidelines to promote "good health and the prevention and treatment of ill health," and physicians are expected to take their recommendations into account. Additionally, NICE issues coverage recommendations, and health commissioners are expected to consider the guidelines in negotiating contracts.
In April 2000, NICE published guidelines for primary total hip replacements, including the recommendation that cemented prostheses be used in THRs due to more evidence of their "long-term viability" when compared to uncemented or hybrid prostheses. The guidelines added that that there was "no cost-effective data . . . to support the use of generally more costly uncemented and hybrid hip prostheses" and that there was "no reliable evidence to support the proposition that the potential ease of revision [for uncemented or hybrid devices] would outweigh its poorer revision rate." Hybrid devices are defined as having an uncemented acetabular compontent and a cemented stem.
Based on a survey of all primary total hip replacements (THRs) in the Trent region from 1990 to 2005, the researchers found that the NICE guidelines had little effect on clinical trends in THRs. The use of uncemented devices rose dramatically between 1999 and 2005, with 19.2% of THR patients receiving an uncemented device in 2005 (up from 6.7% in 1999, the year before the NICE guidelines were released.) Similarly, hybrid devices were gaining in popularity from the early 1990s onward, and when the NICE guidelines were published in 2000, those rates dipped for two years. However, from 2003 onward, use of hybrid devices made significant gains. In 2004, 25.9% of all THRs in the region were hybrid.
The data show that despite the NICE recommendation that surgeons use cemented hips in THRs, cemented hips have declined from representing 84.5% of the THR population in 1999 to 58.8% in 2005. The researchers raise a number of possibilities for the lack of adherence to NICE guidelines, among them that surgeons make individual decisions for their patients; surgeons may disagree with the guidelines; the emergence of new data to support uncemented and hybrid devices that were not available when the NICE guidelines were being prepared; the patient may select their own device, or the device may be otherwise operation-dependent; and surgeons may feel that younger patients would benefit from a device that preserves more bone.
Many of the reasons above allude to surgeons seeking to make the most appropriate choice for their patients, independent of guidelines. While these results are encouraging for device companies, implying that surgeons will use what they believe to be the best technology at their disposal, this trend may be limited by more prescriptive clinical programs: the JBJS paper mentions a U.K. pay-for-performance program that ties clinical choices to reimbursement, which could place increased pressure on surgeons to choose a specific product.
