The landscape analysis, technical/market analysis, key informant interviews, and PSAG workshop generated insights into how PGHD captured via mHealth for SSI surveillance is currently applied in clinical, research, and public health settings. They also contributed to the HTA process by highlighting areas of importance for a range of stakeholders, open issues that require further evidence generation, and by outlining an agenda for future work in this area.
Literature Review
The literature review represented a high-level analysis of the current use of PGHD for SSI monitoring and surveillance. This reflects the current state of the evidence in a relatively young field of study. A significant proportion of the research included in the review was at the pilot/feasibility stage (12 of 34 manuscripts), and only a small number of papers report on randomized controlled trials (2 of 34 manuscripts). Surgical specialties represented in the review included general, vascular, orthopedic, pediatric, reconstructive, cardio/thoracic, colorectal, OB/GYN, otolaryngology, and urology. Two papers did not indicate surgical specialty. Primary and secondary outcomes measured were clinical, cost, design, knowledge extraction, patient/provider satisfaction, utilization, and workflow outcomes. SSI was a specified outcome in 12 of 34 manuscripts. Fifteen manuscripts reported findings from real-world use of an mHealth application; 18 reported on theoretical use (such as application mock-up testing); and one manuscript did not report app use. Thirty manuscripts reported on patients or their care partners as the population of study, and three reported on healthcare providers.
Salient findings of the literature review include:
Patient-submitted photos aid in identification of post-op complications, reduce ER visits/hospital readmissions, and alter courses of care.
Inter-rater agreement is moderate to high in assessment of wound photos and subsequent clinical recommendations.
Patients and clinicians give high satisfaction and usability ratings for mHealth applications that leverage PGHD for post-operative care.
Patient success in using mHealth apps (e.g., taking/submitting wound photos) is moderate to high.
The quality of digital photos is generally sufficient for clinical use.
Technical and Market Review
The search identified 11 apps for review. These were How2Trak, imito, mHeals, mPOWEr, QoC Health, SeamlessMD, Synced Care, Theia, WoundCheck, WoundSmart, and a Vanderbilt University app deployed through REDCap, an academic survey and database tool also developed at Vanderbilt. Products were reviewed and compared based on available knowledge pulled from the published literature and product websites. Parameters examined included: functionality and workflow, deployment settings, technical features and analytic capabilities, data types and specified measures related to PGHD/SSI, and user features. An overview of the apps reviewed is in Table 3. Additional details are available in the PSAG Report, included in Appendix C.
Key Informant Interviews
Twenty-one individuals were interviewed, representing six perspective groups, seven medical specialties, and four international perspectives (see Table 4). Interviews utilized a semi-structured interview guide specific to each key informant’s area of expertise (see Appendix C: PSAG Report for sample interview guide). Interviews were recorded and transcribed. Written summaries were created to articulate key concepts that emerged from each conversation. Cross-cutting topics including insights into provider user experience, provider perspectives on the patient user experience, data integration, the definition of SSI informed by PGHD, and methods of knowledge extraction (see Table 5 for details).
PGHD Stakeholder Advisory Group Workshop
Stakeholder groups represented at the PSAG workshop included scholars, researchers, clinicians, infection preventionists, quality improvement (QI) directors, policy specialists, and technology experts. Individuals represented institutions and organizations across the US, including Washington, California, Georgia, Virginia, Michigan, Tennessee, Minnesota, South Carolina, Massachusetts, Wisconsin, and Missouri, as well as Ontario and Nova Scotia, Canada.
Twenty-three individuals attended the meeting in person, and five attended remotely via teleconference. For those unable to attend the workshop in person, remote participation was facilitated via interactive teleconference platforms. The platforms used enabled both remote and in-person attendees to participate throughout the workshop by posting comments, asking questions, and posting related links. This enhanced participant engagement, and helped to ensure all attendees were able to participate fully in discussions.
Deliverables derived from the workshop included the morning slide presentations, draft proceedings documents based on delivered remarks, and summary content analysis performed on stakeholder discussion sessions. A full report of the workshop was prepared by the project team and Scientific Board, and is included here as Appendix C. Workshop participants were invited to review and provide feedback on a draft of this report, and their contributions were incorporated into the final version.
Feedback at the PSAG workshop highlighted the need for additional input from patients. PSAG attendees recommended patient engagement and patient co-design as important aspects of developing sustainable programs for leveraging PGHD to monitor for SSI. Important elements of the patient experience discussed by stakeholders included the necessity for sufficient patient training on app use prior to hospital discharge, the use of caretakers to support app utilization in elderly populations, and design features that make app use streamlined and easy to understand. It was recommended that the project team carry out additional interviews with patient key informants in order to broaden what is known about patient experience, and the value propositions held by this stakeholder group. Following the PSAG workshop the project team worked with Scientific Board members to identify patients who were willing to participate as key informants, and to carry out a second round of forthcoming interviews.