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

Abstract

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.

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Data availability

Not applicable.

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Acknowledgements

We would like to acknowledge the support of all the general surgeons at York and Scarborough, as well as the Medical Illustration Team at York. We would also like to acknowledge and thank the support and input of our patients, to whom our work is dedicated.

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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by OS, PC, TM, PL and SC. The first draft of the manuscript was written by MA and all authors commented on the previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to S. Chintapatla.

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Conflict of interest

All authors (Mariam Asarbakhsh, Olivia Smith, Praminthra Chitsabesan, Tom MacLeod, Philip Lim and Srinivas Chintapatla) declare that they have no conflict of interest.

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No Human and animal rights issues were invovled in the production of this manuscript.

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Asarbakhsh, M., Smith, O., Chitsabesan, P. et al. A multistage process leading to the development of a structured consent form and patient information leaflet for complex abdominal wall reconstruction (CAWR). Hernia 25, 277–285 (2021). https://doi.org/10.1007/s10029-020-02260-0

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Keywords

  • CAWR
  • PIL
  • Consent form
  • PDSA cycle