Dr. Hu recommended using the “IDEAL” methodology and provided an example using robotic surgery. IDEAL stands for idea, development, assessment, and long-term study and provides a framework for assessing comparative effectiveness studies. This framework can be applied to robotic urology surgery. Namely, the idea (stage 1) is reported as a “first in man” study. Development can be described in early (stage 2a) and intermediate (stage 2b) phases. Stage 2a for the robotic surgery example would be single institution case studies (e.g. first 100 cases). Stage 2b is rapid adoptions and allows for secondary data analysis of large numbers of cases (e.g. by using Medicare). The Medicare analyses, however, are not without flaws, and they have been criticized for being based on administrative codes rather than patient-reported outcomes. Moreover, Medicare data specifically consider older men (65-years or older) and include lower volume, less experienced surgeons. Randomized trials may account for this and such a trial was recently reported by Yaxley and colleagues. Surgery times were shorter for robotic surgery and there was less blood loss and narcotic pain medication use using the robotic approach.
The final stage represents long-term monitoring (IDEAL stage 4). SEER-Medicare linked analyses have demonstrated that overall survival factors robotic prostatectomy over open prostatectomy (HR. 0.79, 95% CI 0.67-0.93, p = 0.003). However, no benefit in prostate cancer specific mortality (HR 0.73, 95% 0.46-1.15, p = 0.171).
In conclusion, comparative effectiveness research is relevant to multiple stakeholders. The IDEAL framework can be used as a model for evaluating dissemination of technology or devices. Lastly, these outcome measures enable us to measure the learning curve for a surgeon and maturation of technique.
Presented By: Jim Hu, MD, MPH
Written By: Benjamin T. Ristau, MD, Fox Chase Cancer Center, Philadelphia, PA
at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA