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. 2021 Jul 21;22(1):471.
doi: 10.1186/s13063-021-05398-z.

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)

NIHR Global Health Research Unit on Global Surgery
Collaborators

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)

NIHR Global Health Research Unit on Global Surgery. Trials. .

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.

Keywords: Abdominal surgery; Digital follow-up; Global surgery; Outcome assessment; Patient-reported outcome measure; Surgery; Surgical site infection; Telephone follow-up; Trial methodology; Trial retention.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Map of participating countries. Participating countries marked in red
Fig. 2
Fig. 2
TALON-2 study with a trial patient pathway. WHQ=Bluebelle Wound Healing Questionnaire, SWAT=study within a trial, D30 postoperative day 30 with day 0 as date of surgery
See this image and copyright information in PMC

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