Developing a pathway for remote assessment of surgical wounds with partners in low- and middle-income countries: An approach for efficient trials and resilient perioperative systems

Abstract

Background: Surgical site infection (SSI) is the most common complication of abdominal surgery, and commonly occurs after hospital discharge. When patients in low- and middle-income countries (LMICs) undergo surgery, they are three times more likely to have a SSI than patients in high-income countries. Returning to hospital for routine face-to-face follow-up is the accepted gold standard for diagnosing a SSI but can be challenging in many environments, and resource intensive for healthcare teams. Aims: The overall aim of this thesis was to develop a high-quality pathway for remote surgical wound assessment using telemedicine that can be delivered flexibly across diverse healthcare settings. First, I aimed to evaluate the feasibility and accuracy of telemedicine in the detection of SSI in existing data. Second, I aimed to explore the cross-cultural equivalence of a Wound Healing Questionnaire (WHQ) across several LMICs and make recommendations for its adaptation for use in global surgery research and practice. Third, I aimed to test the feasibility and accuracy of the adapted WHQ in diagnosis of SSI. Methods: The primary outcome of interest in this thesis was SSI reported up to 30-days after surgery using the US Centres for Disease Control criteria. First, I compared the rates of SSI using telemedicine to those with in-person review in two data sources: (A) an international cohort study of adult patients discharged from hospital before 30-days after abdominal surgery; (B) a systematic review with meta-analysis of rates of SSI detection conducted in accordance with PRIMSA guidelines (PROSPERO:192596). Second, to recommend adaptations to the WHQ outcome measure for global implementation, I conducted a mixed-methods study across seven LMICs. Qualitative data were obtained from interviews and focus groups with local researchers with deductive coding aligned to cognitive theory. Quantitative data were collected in a prospective cohort study and Rasch analysis was used to explore measurement properties of the WHQ. I triangulated these data to make recommendations for cross-cultural and cross-language adaptation. Third, I conducted a validation cohort study within a randomised trial (FALCON, NCT03700749) where consecutive patients undergoing abdominal surgery for a range of indications underwent telephone assessment with the WHQ (index test) up to 72-hours before their face-to-face assessment (reference test). I worked with Community Engagement and Involvement (CEI) partners to optimise the measurement pathway. Results: The SSI rate reported using telemedicine in the cohort data was lower than with in-person follow-up (11.1% versus 13.4%, p4 demonstrated sensitivity of 0.701 (0.610-0.792), specificity of 0.911 (0.878-0.9430), positive predictive value of 0.723 (0.633-0.814) and negative predictive value of 0.901 (0.867-0.935). Discussion: Current methods for remote detection of SSI are inadequate, missing 1 in 3 patients with infection. This thesis describes the adaptation and validation of the WHQ, demonstrating that a telephone pathway for wound assessment is feasible and moderately accurate. The adapted WHQ is now ready for global implementation in research and routine postoperative surveillance, using the co-designed toolkit to optimise local measurement processes

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