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.
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.
| Original language | English |
|---|---|
| Article number | 471 |
| Number of pages | 11 |
| Journal | Trials |
| Volume | 22 |
| Issue number | 1 |
| Early online date | 21 Jul 2021 |
| DOIs | |
| Publication status | Published - Dec 2021 |
Bibliographical note
Funding Information:TALON is funded through a doctoral research fellowship from the NIHR Academy (NIHR300175). The FALCON trial is funded by a National Institute for Health Research (NIHR) Global Health Research Unit Grant (NIHR 16.136.79). The funder and sponsor had no role in the study design or writing of this report. The funder has approved the submission of this report for publication. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, or the UK Department of Health and Social Care.
Publisher Copyright:
© 2021, The Author(s).
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
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)