Constructive Technology Assessment (CTA) to assess the potential value of new technologies: The allocation and application to Sagittal Balance and spino-pelvic parameters in the clinical pathway of degenerative spine diseases.

Summary Objectives: Constructive Technology Assessment (CTA) is proven to be a valuable concept for medical technologies that are still under development. This study applies CTA to assess the potential value of an innovative measurement concept in spine surgery, Sagittal Balance (SB). Prior research suggests improved clinical outcomes resulting from the SB application; however, it is not widely used due to various, still unidentified reasons. In this case, CTA was particularly utilized to identify these reasons and therewith SB’s most efficient pathway allocation. Methods: Data were collected using semi-structured interviews among European surgical spine experts with different experience-levels regarding SB. The interviews were structured according to the CTA domains: clinical, economic, patient-related and organizational. Subsequently, feedback from the interviewees was clustered according to specific clinical pathway stages. Results: Nine semi-structured interviews were conducted. All CTA domains bared implementation barriers hampering adequate technology application (e.g. imaging and calculation difficulties), result interpretation (e.g. recognising different spine morphologies) and subsequent surgical interventions (e.g. comprehensive surgeries). CTA further assists to seek optimal allocation of SB in the clinical pathway by identifying implementation barriers in the diagnosis, treatment, post-treatment and follow-up stage. Conclusion: SB was found to be a valuable concept by interviewees as diagnostic tool and outcome measure in the investigated clinical environments although its feasibility for the post-treatment and follow-up phase was limited and warrants further research. CTA has shown to be a useful framework to assess the potential value of innovative technologies and additionally can contribute to its ideal allocation among clinical pathway stages.