The DISCLOSE study

  • Research type

    Research Study

  • Full title

    The DISCLOSE study: Development and pIloting Core discLosure for infOrmed conSent for surgEry

  • IRAS ID

    171156

  • Contact name

    Angus McNair

  • Contact email

    angus.mcnair@bristol.ac.uk

  • Sponsor organisation

    University of Bristol

  • Duration of Study in the UK

    1 years, 0 months, 2 days

  • Research summary

    Patients’ have an ethical right to give permission before surgeons operate through a process called informed consent. This important concept underpins the four million surgical operations that are performed each year in the United Kingdom. There are challenges, however, in ensuring that patients receive the right information in an understandable way. Evidence suggests that this process often falls short of best practice because clinicians may underestimate patients’ information needs, overestimate the amount of information they give or lack communication skills. Consequently, patients may feel pressured to consent for a procedure that they have not adequately discussed.

    The concept of “core disclosure” is a proposed solution to this problem. Essential baseline information, as determined by patients and experts, is initially communicated to stimulate individualised discussions. "Core disclosure" is not novel information - it includes only issues that are commonly covered in consultations such as the benefits and risks of surgery - but it represents a way of introducing consistency. “Core disclosure” has been defined for bowel and gullet cancer surgery but it is not known how to use this information could be used in clinical practice.

    This study aims to develop a way of using core disclosure in clinical practice. This will be done using methods recommended by the Medical Research Council. Surgeons will be interviewed to explore their views on using core disclosure in their practice. Core disclosure will then be communicated in consultations with patients with bowel and gullet cancer, and discussions between surgeons and patients audio recorded. Follow-up interviews will explore ways that information can be improved then, after refinement, the process is repeated. The study will conclude when patients recommend no further improvements to the information.

  • REC name

    London - Bromley Research Ethics Committee

  • REC reference

    15/LO/0617

  • Date of REC Opinion

    31 Mar 2015

  • REC opinion

    Favourable Opinion