Risk versus benefit: putting outcomes first
Surgical technique is continually evolving, enabled through pioneering surgeons and novel technologies, but what should be the drivers for such progress? Clinical outcome? Speed of recovery? Procedural time?
The trite answer is all of the above, but what happens when there are trade-offs? The picture is far more commonly complicated by a need to balance improvement in some endpoints with drawbacks elsewhere. Improved cosmesis is laudable, but not when the procedural cost is substantially higher. Faster operating times help manage cost and treat more patients, but would not be tolerated if they pushed up the risk of complications.
It is beholden upon innovators to consider risk vs benefit in the round and to keep clinical outcome foremost in mind.
A meta-analysis was recently published in CMAJ Open [DOI: 10.9778/cmajo.20140048] concluding that minimally invasive discectomy surgery did not improve long-term function or reduce long-term extremity pain compared with open surgery. At the same time, the evidence suggested overall higher rates of nerve-root injury, incidental durotomy, and reoperation. In some respects, this may not be surprising since a minimally invasive approach is typically associated with higher procedural complexity. What is interesting about this study though is how it highlights that evidence such as this is rarely if ever available at the early stages of adoption, making systematic review - as part of new device comparative effectiveness studies - challenging.
In the absence of this, it is beholden upon innovators to consider risk vs benefit in the round and to keep clinical outcome foremost in mind. This need not hamper innovation but may lead to development of new training materials or optimized usability alongside the core device program. It may put greater emphasis on post-market surveillance, and it should also help us identify the right products to develop for the right reasons and avoid the trap of introducing new technology or change for their own sake.