A multistage process leading to the development of a structured consent form and patient information leaflet for complex abdominal wall reconstruction (CAWR).

Purpose: Informed consent is vital in surgery. The General Medical Council, UK and Royal College of Surgeons of England provide clear guidance on what constitutes the process of informed patient consent. Despite this, evidence suggests that the consent process may not be performed well in surgery. We utilised a staged patient-centred approach and rigorous methodology to develop a standardised patient information leaflet (PIL) and pre-written structured consent form for complex abdominal wall reconstruction (CAWR).

Methods: We utilised the principles of Deming's Plan-Do-Study-Act (PDSA) cycles to approach the process. Buzan's mind maps were used to identify the stakeholders and deficiencies in the consent process ('Plan' phase). The content of the PIL and pre-written consent form was then developed in collaboration with stakeholders ('Do' phase). Multidisciplinary and multidepartmental feedback was obtained on the proposed content and amendments were made ('Study' and 'Act' phases).

Results: We successfully produced a clear, focused PIL and structured consent form, in Plain English, presenting accurate, relevant and detailed information in a highly understandable way. The PIL had a Flesch Reading Ease score of > 80, demonstrating a high level of readability and comprehensibility, with positive implications for informed patient decision making and preparedness for surgery.

Conclusion: Through sharing the process that we undertook, we aim to support other abdominal wall units who wish to develop and improve their own consent process.