Misha Sidapra is an NIHR Academic Clinical Fellow and surgical trainee at Hull University Teaching Hospitals NHS Trust.

She is currently researching methods for improving clinical trial design in patients with surgical wounds, in association with Hull York Medical School.

Poster Presentation (Research category) at The Society of Tissue Viability 2023 Conference

Development of a Core Outcomes Set (COS) for Surgical Wounds Healing by Secondary Intention (SWHSI)

Abstract

Background – Living with a surgical wound healing by secondary intention (SWHSI) can have a huge impact on a patient’s life. Research to improve treatments in this patient population has been hindered by the lack of a standardised approach to clinical trials. We aim to tackle this issue is by developing a core outcomes set (COS) for trials in SWHSI.
A COS is a consensually agreed minimum set of outcomes to be reported in all clinical trials completed in a given population. High-quality COS development requires the representation and input of all stakeholder groups involved in the care of the patient population, including patients themselves, healthcare experts, researchers and other parties. Using a pre-determined set of clinically relevant and meaningful outcomes in clinical trial design allows for easy comparison and meta-analysis of results, making each individual study more efficient and cost-effective as part of the whole body of research.

Methods – Development of the COS will be completed according to guidance set out by COMET (Core Outcome Measures in Effectiveness Trials) Initiative guidance, and has been registered with their global database of COS development projects.

• Stage 1: Conduction of a systematic review to identify all currently used outcomes. We will also complete patient interviews and clinical expert surveys to identify any additional outcomes for inclusion.
• Stage 2: A three-round Delphi survey process to rank the identified outcomes into critically important and unimportant categories.
• Stage 3: A consensus-building meeting to finalise the list of outcomes to be included in the COS.
  We will be looking to recruit a minimum of 160 participants across stakeholder groups for this study.

Results – Results will be presented at relevant conferences and published in scientific journals to ensure maximal uptake of the COS in future trial designs.

Discussion – This study will allow researchers to develop future clinical trials with the confidence that their outcomes are clinically pertinent, important to patients and conform to a consensually decided professional standard. It will allow for easier comparison and better combination of results for meta-analysis, thereby increasing the utility of any individual study.