The evidence required to establish a sufficient effect on health outcomes typically includes:
- Consistent results from well-designed, well-conducted studies in clearly-defined populations.
- Well designed and conducted studies generally controlled for bias through random allocation of participants; blinded assessment of outcomes; minimizing loss to follow-up; and complete reporting of results. Study populations are representative of the population of clinical interest. Study size is adequate to test the hypothesis and assumptions for calculating study power are clearly reported.
- Studies assessing the effects of the technology on health outcomes, including both the beneficial and harmful effects on length of life, quality of life and ability to function.
- Evidence from effectiveness studies or post-marketing studies that confirm that the observed effects of the intervention are generalizable outside the research setting.
- Evidence from effectiveness studies or post-marketing studies to assess long term effects of the technology on health outcomes.
- Clinical study data available through a curated open data access source.
The Blue Cross and Blue Shield Association is a national federation of 36 independent, community-based and locally-operated Blue Cross and Blue Shield companies that collectively provide healthcare coverage for more than 106 million members across all 50 states, the District of Columbia and Puerto Rico.
Daniel Cher, M.D., vice president of clinical affairs at SI-BONE commented, "there is abundant evidence showing that the sacroiliac joint is a significant contributor to lower back pain and that common types of SI joint dysfunction can be effectively treated with a minimally invasive surgical procedure using the triangular iFuse Implant, which we brought to market in 2009. That said, the SI joint has been under-diagnosed and under-treated for decades and our philosophy has been to take a high level scientific approach, including well-designed and well-executed clinical studies so that the data from these studies could stand on their own for educational, clinical and patient purposes."