Feasibility and diagnostic accuracy of Telephone Administration of an adapted wound heaLing QuestiONnaire for assessment for surgical site infection following abdominal surgery in low and middle-income countries (TALON): protocol for a study within a trial (SWAT)

Abstract

Background Surgical site infection is the most common complication of abdominal surgery, with a global impact on patients and health systems. There are no tools to identify wound infection that are validated for use in the global setting. The overall aim of the study described in this protocol is to evaluate the feasibility and validity of a remote, digital pathway for wound assessment after hospital discharge for patients in low- and middle-income countries (LMICs). Methods A multi-centre, international, mixed-methods study within a trial, conducted in two stages (TALON-1 and TALON-2). TALON-1 will adapt and translate a universal reporter outcome measurement tool (Bluebelle Wound Healing Questionnaire, WHQ) for use in global surgical research (SWAT store registration: 126) that can be delivered over the telephone. TALON-2 will evaluate a remote wound assessment pathway (including trial retention) and validate the diagnostic accuracy of this adapted WHQ through a prospective cohort study embedded within two global surgery trials. Embedded community engagement and involvement activities will be used to optimise delivery and ensure culturally attuned conduct. TALON-1 and TALON-2 are designed and will be reported in accordance with best practice guidelines for adaptation and validation of outcome measures, and diagnostic test accuracy studies. Discussion Methods to identify surgical site infection after surgery for patients after hospital discharge have the potential to improve patient safety, trial retention, and research efficiency. TALON represents a large, pragmatic, international study co-designed and delivered with LMIC researchers and patients to address an important research gap in global surgery trial methodology.

Use of Telemedicine for Postdischarge Assessment of the Surgical Wound

“…A universal outcome reporter “Bluebelle” Wound Healing Questionnaire has demonstrated promise as tool for remote detection of SSI, demonstrating excellent discrimination and reliability 45 , 46 ; however, this has only undergone evaluation in a single language in one country, and cultural and linguistic adaptation and validation to support international application. 47 No included studies used videography to help identify SSI; this may prove a useful adjunct to future development in this area.…”

“…Seventh, we were unable to differentiate here between different methods of remote wound assessment (ie, telephone vs video), although from ongoing work across our network it is likely that a majority of assessment would have been telephone-based. 47 Eight, the cohort study used a pragmatic observation methodology and did not standardize training or delivery of telemedicine. This should therefore be interpreted as the real-world effectiveness of telemedicine, rather than the potential efficacy of telemedicine in an optimized system.…”