ASSIST aims to evaluate and define the current uses and possible roles of PGHD and mobile devices in post-operative surgical care and SSI surveillance, provide a set of recommendations for PGHD that incorporates input from experts and other key stakeholders, and identify open issues on post-operative use of PGHD for which additional evidence and experience are needed to optimize application of those data for clinical and public health purposes.
This Health Technology Assessment (HTA) was carried out in order to address the need for systematic study of current uses of PGHD and to better define how PGHD should be leveraged for SSI monitoring and surveillance across clinical, research, and public health settings. To conduct the HTA, we used an adapted framework that closely paralleled the National Institutes of Health “HTA 101” framework and the Center for Medical Technology Policy process for developing Effectiveness Guidance Documents (see Appendix A).9-11 This stakeholder-driven approach incorporated methods for engaging expertise, refining topic areas by available evidence and expert judgement, gathering and organizing evidence, developing recommendations, reaching agreement on guidance, incorporating public comment, and disseminating findings (see Table 1). This methodology encompassed the formation of a Scientific Board, refining of relevant topics, gathering evidence and expert judgement through a landscape analysis (including a literature review, key informant interviews, and a technology/market review), and stakeholder engagement activities designed to elicit additional expertise and feedback. The process was iterative, incorporating guidance from the Scientific Board and other stakeholders at each step. As the work progressed, the project team synthesized the learnings, drafted work products (e.g., evidence summaries, presentations, and workshop reports), and relayed these items to the Scientific Board for feedback and refinement. The project team and Scientific Board met monthly via teleconference, and in-person at critical junctures in the project. These in-person meetings were integral to the HTA process, and allowed the Scientific Board and project team to move the HTA process forward by refining the scope and topic of the HTA (initial meeting), reviewing and providing feedback on initial findings (PSAG workshop), and refining recommendations and prioritizing future work (end of year 1 meeting on 10/21).
