The HTA process encompassed four primary activities: a landscape analysis that synthesized current evidence from the published literature; a technical/market analysis that reviewed mHealth products available for use in SSI surveillance; key informant interviews with targeted experts and leaders in the field; and a PSAG workshop designed to generate feedback from a wide range of stakeholders. These activities are summarized here.
Landscape Analysis
The topics identified by the Scientific Board guided the project team to retrieve and assemble available evidence. This evidence appraisal started with a review of the published and gray literature. As technology and implementation efforts typically move faster than publications, we augmented the landscape analysis with technical and market scans of available post-operative apps. We identified commercial and other mobile apps that are offered or have been used to allow patients to collect postoperative images or other data, and developed briefs on the technology, extent of usage, and notable characteristics of those systems. We also sought evidence from expert judgement and experience through key informant interviews. Initial synthesis of the evidence was performed by the project team and reviewed by the Scientific Board.
Literature Review
The topics identified by the Scientific Board guided the project team to retrieve and assemble available evidence. This evidence appraisal started with a review of the published and gray literature. The purpose of the evidence review was to gain an understanding of the current application of mHealth and PGHD in post-operative wound management. The literature search was conducted by a University of Washington biomedical and translational sciences librarian. The initial search yielded more than 4,000 references, 129 of which were included for the next phase of review. Additional searches of the literature were conducted on a weekly basis throughout the review period to capture additional potentially relevant articles as they became available. This process yielded an additional four manuscripts, bringing the total number of references to 133. Seven of these were ineligible for inclusion because they did not meet initial screening criteria (e.g., availability in English language), and following their removal, 126 references remained. These 126 were included in the review of abstracts. We performed the initial review of abstracts to screen for inclusion in the final literature review. Inclusion criteria stipulated that the manuscript 1) address the use of PGHD in post-operative care following hospital discharge, and 2) focus on a use-case specific to monitoring for or diagnosing SSI. In total, 74 manuscripts were excluded from the final review because they did not meet these criteria (for full exclusion criteria see Appendix B). In addition to the 74 excluded manuscripts, 18 manuscripts were tagged for use for background purposes. These papers, though not included in the final literature review, were important for understanding the broader context within which use of PGHD for SSI monitoring and surveillance is situated. In total, 34 manuscripts, including 26 peer-reviewed manuscripts and 8 research briefs and conference abstracts, were included in the literature review (see Appendix C: PSAG Report for bibliography).
Technical and Market Review
As technology and implementation efforts typically move faster than publications, we augmented the literature review with technical and market scans of available post-operative apps. We identified commercial and other mobile apps that are offered or have been used to allow patients to collect postoperative wound images or other data, and developed briefs on the technology, extent of usage, and notable characteristics of those systems. Apps used directly by patients or caregivers in the post-discharge setting for tracking surgical wounds were included for review. Apps were identified through the published literature, colleagues of the ASSIST team and Scientific Board, at the Health Information and Management Systems Society (HIMSS) annual meeting, and through online searches for relevant mHealth products. Excluded from the review were apps intended only for provider use, apps used primarily for chronic wound tracking, and apps intended primarily for care coordination.
Key Informant Interviews
Our team conducted interviews with key stakeholders in the field of mHealth and PGHD for SSI detection and monitoring to elicit information on their experience with, and perspectives on PGHD use in post-operative SSI diagnosis and surveillance. Areas of inquiry were informed by the project team’s experience, and input from the Scientific Board. Interviews gave our team a more comprehensive picture of how PGHD is captured and implemented across the health system and identified evidence gaps in the use of PGHD for healthcare systems and industry partners to address.
The interviews were conducted to uncover the minority view that might not make it to publication, but that likely influences practice patterns, data reporting, and interpretation in the field. Key informants included a variety of expert perspectives, including clinicians, researchers, infection preventionists, design and ethics experts, and data scientists, including a high school student with an extraordinarily high level of experience in coding and mHealth development. The initial sample of key informants was drawn from experts known by the project team and Scientific Board. Additional key informants were identified through contacts suggested by first round interviewees, authors of published studies identified in the evidence review, and creators of apps identified by the mHealth apps review.
PGHD Stakeholder Advisory Group Workshop
The purpose of the PSAG workshop was to create insights into how stakeholders approach the design, assessment and adoption of new technology, to highlight gaps in current knowledge about PGHD integration into SSI diagnosis and surveillance efforts, and to elicit stakeholder feedback on draft practice guidelines and areas that need further study. Participants included the project team, the Scientific Board, and representative members of the PSAG. This full-day workshop included a morning session where Scientific Board members delivered the preliminary results of the landscape analysis, and findings from key informant interviews, through topic-based presentations to summarize the scope of the HTA. The afternoon session included Scientific Board member led topic-based breakout discussion sessions with PSAG to refine evidence based guidelines, identify evidence gaps and establish priority areas for future research. The workshop was audio recorded to enable transcripts to be produced of the proceedings.
The workshop was planned to directly follow the Surgical Infection Society 2018 annual meeting in Westlake Village, California, in order to facilitate participation by those attending the meeting. In addition to the project team and Scientific Board members, attendees included key informants, Surgical Infection Society members and other meeting attendees, and other key leaders in the intersecting areas of PGHD, SSI, and infection prevention.