Authors
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James Glasbey
NIHR Global Health Research Unit on Global Surgery, School of Health Sciences, University of Birmingham, United Kingdom
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Aneel Bhangu
NIHR Global Health Research Unit on Global Surgery, School of Health Sciences, University of Birmingham, United Kingdom
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Stephen Tabiri
Department of Surgery, School of Medicine, University for Development Studies and Tamale Teaching Hospital, Tamale, Ghana
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Joana Simoes
NIHR Global Health Research Unit on Global Surgery, School of Health Sciences, University of Birmingham, United Kingdom
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Omar Omar
NIHR Global Health Research Unit on Global Surgery, School of Health Sciences, University of Birmingham, United Kingdom
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Faustin Ntirenganya
Department of Surgery, School of Medicine and Pharmacy, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda
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Antonio Ramos de la Medina
Global Surgery Research Centre. Hospital Español de Veracruz. Veracruz, Mexico
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Bryar kadir
NIHR Global Health Research Unit on Global Surgery, School of Health Sciences, University of Birmingham, United Kingdom
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Dhruva Ghosh
India Hub, National Institute for Health Research Global Health Research Unit on Global Surgery, Christian Medical College, Ludhiana, India
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Sivesh Kamarajah
NIHR Global Health Research Unit on Global Surgery, School of Health Sciences, University of Birmingham, United Kingdom
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Ismail Lawani
Visceral Surgery Unit, Department of Surgery and Surgical Specialties, Faculty of Health Sciences, University of AbomeyCalavi, Cotonou, Republic of Benin
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Parvez Haque
India Hub, National Institute for Health Research Global Health Research Unit on Global Surgery, Christian Medical College, Ludhiana, India
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JC Allen Ingabire
Department of Surgery, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda
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Ewen Harrison
National Institute for Health Research Global Health Research Unit on Global Surgery, Centre for Medical Informatics, Usher Institute, University of Edinburgh, UK
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Adewale Adisa
Department of Surgery, Obafemi Awolowo University, Ile-Ife, 220005, Osun State, Nigeria
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Adesoji Ademuyiwa
Paediatric Surgery Unit, Department of Surgery, Faculty of Clinical Sciences, College of Medicine, University of Lagos, Lagos, Nigeria
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Elizabeth Li
NIHR Global Health Research Unit on Global Surgery, School of Health Sciences, University of Birmingham, United Kingdom
Keywords:
surgical site infection, outcomes, risk of bias
Abstract
Background: Surgical site infections (SSIs) significantly impact patient outcomes, with rates reaching up to 20% after surgery, leading to higher morbidity, prolonged hospital stays, and increased costs. The assessment of randomized controlled trials (RCTs) related to SSIs has been challenging due to the lack of a specialized Risk of Bias (RoB) tool, as existing tools like the RoB-2 are not surgery-specific. To address this gap, we developed an adapted SSI-specific RoB-2 tool.
Methods: This tool was created through a four-stage consensus process involving surgeons, trial statisticians, and methodologists with extensive experience in international SSI trials.
Results: The process identified ten critical domains relevant to assessing RCTs on SSI interventions. Of these, eight domains were prioritized as essential for the final tool, while two were considered desirable but less critical due to the challenges of blinding in surgical contexts.
Conclusion: The adapted RoB-2 tool is tailored to the unique aspects of SSI trials, offering a more focused and practical means of evaluating RCT quality. It not only improves the assessment of existing studies but also guides the design of future RCTs, enhancing the quality of evidence in SSI research. The tool's application in meta-analyses will likely lead to more reliable and generalizable results, informing clinical practice and policy decisions related to SSI prevention and management.
Section
Original research paper
