Patient and Public Advisory Group (PPIAG) for Guided Instrumentation for Fetal Therapy and Surgery (GIFT-Surg)

PPIAG
The first meeting of the Patient and Public Advisory Meeting for the project, held at University College London.

  • Overview

    At the start of the project a patient and public advisory group was set up. The members are made up of researchers involved in GIFT-Surg, Richard Ashcroft, Professor of Bioethics at Queen Mary University London, and representatives from the five charities GIFT-Surg is involved with:

    • ARC – Antenatal Results and Choices
    • Bliss – for babies born to too soon, too small, too sick
    • CDH UK – the Congenital Diaphragmatic Hernia Support Charity
    • Shine – Spina bifida and Hydrocephalus information, networking and equality
    • TAMBA – Twin and multiple birth association

  • Aims

    The PPIAG meets three times a year to discuss the ethical implications of our research, and to ensure the research is relevant to patients and their families.

    The aim of the group is to:

    • Consider safety, efficacy and parental concerns when developing new equipment and techniques
    • Develop and prioritise outcome measures which are meaningful and important to parents
    • Create an ethical framework for the project considering aspects such as:
      • Does this type of imaging empower women to make choices about their pregnancies or does it makes such decisions more difficult?
      • How far does the technology actually improve things for the women, children and families affected
      • What should be the approach if intervention is recommended for a sick twin, with the potential of endangering the other healthy twin?
      • How should we approach consent for procedures where there is limited evidence at present on effectiveness, and the risks of the procedure?
    • Guide the creation and implementation of patient questionnaires, information material, and consent for inclusion in on-going research, to ensure it is appropriate and in-depth, and to help application for ethical approval
    • Consider the cost-effectiveness of these procedures, and the ethical challenges presented by this

  • PPIAG meeting summaries

    26th January 2015

    Present:

    Clinicians and academics:

    • Dr Anna David, Associate Professor in Obstetrics and Maternal/Fetal Medicine, UCL (Chair)
    • Prof Richard Ashcroft, Professor of Bioethics, Queen Mary University of London
    • Dr Tom Doel, Postgraduate Research Associate, UCL
    • Dr Dzoshkun Shakir, Postgraduate Research Associate, UCL
    • Dr Kevin Cao, Trainee in Paediatric Surgery, North London Deanery
    • Dr Rosalind Pratt, Clinical Research Fellow, UCL

    Representatives from voluntary organisations:

    • Helen Turier, TAMBA (Twins and Multiple Birth Association) www.tamba.org.uk/
    • Zoe Chivers, Bliss www.bliss.org.uk
    • Gill King,
    • Jane Fisher, ARC
    • Beverley Power, CDH UK www.cdhuk.org.uk/
    • James Power, CDH UK
    • Robin Barnatt, Shine charity http://www.shinecharity.org.uk/

    At this meeting the group met Sebastien Ourselin, the Principle Investigator on GIFT-Surg. He explained his background, and his interest in the project. He also provided a summary of the Welcome Trust EPSRC 6 month review visit on 18th December 2014, and the excellent outcome.

    There was then a presentation from Richard Ashcroft, who is working on a paper discussing the ethical issues arising from fetal surgery. Issues that were raised included:

    • That it is likely that outcomes will be different for different pregnancies, and in some cases a fetus that would not survive without intervention might now survive but with complex medical problems and lifelong disabilities.
    • In his experience of discussing decision making with different populations (culturally, religiously, from different backgrounds etc) the decision is very individual.
    • We are transferring a complex situation or diagnosis into a difficult decision for individuals to make.

    Areas that were discussed with the members included those around consent, legal issues, what outcomes really matter to parents, and consideration of cost effectiveness.

    Finally there was then a presentation on the development of software that allows safe transfer of anonymised imaging between institutions, and the development of surgical planning programmes.

    18th May 2015

    Present:

    Clinicians and academics:

    • Dr Anna David, Associate Professor in Obstetrics and Maternal/Fetal Medicine, UCL (Chair)
    • Prof Richard Ashcroft, Professor of Bioethics, Queen Mary University of London
    • Dr Kevin Cao, Trainee in Paediatric Surgery, North London Deanery
    • Dr Rosalind Pratt, Clinical Research Fellow, UCL

    Representatives from voluntary organisations:

    • Helen Turier, TAMBA (Twins and Multiple Birth Association) www.tamba.org.uk/
    • Gill King, ARC, (Antenatal Results and Choices) www.arc-uk.org
    • Beverley Power, CDH UK (The Congenital Diaphragmatic Hernia Charity) www.cdhuk.org.uk/
    • James Power, CDH UK
    • Gillian Yaz, Shine charity (Spina Bifida and Hydrocephalus charity) http://www.shinecharity.org.uk/

    At this meeting the members were shown the new GIFT-Surg website, and they were asked their opinion, especially regarding the charities segment. The decision was made to add additional information on the charities.

    The members were also told about recent dissemination of work, with a presence at the International Fetal Medicine and Surgery Societies Annual Conference, where several members of the group presented work.

    Richard Ashcroft then presented work on Issues in Fetal Intervention. Consent was explored in depth, discussing the difficulties in decision-making in pregnancy, where parents may have opposing opinions. Also as the majority of fetal surgery is experimental, all the risks and benefits may not be known, and definite statistics cannot be quoted. The legal and ethical aspects of consent were discussed at length. Richard Ashcroft will use this discussion to help guide his further research and paper, and it was decided future meetings should look at the role of charities within research.

    Finally the members helped the GIFT-Surg team in developing a public engagement questionnaire, and in developing patient information and consent documents for an ethics application to perform additional fetal MRI.

    9th November 2015

    Present:

    Clinicians, academics and GIFT-Surg members:

    • Prof Jan Deprest, Professor of Obstetrics and Gynaecology, KUL, Consultant Obstetrician and Gynaecologist, UZ Leuven
    • Dr Tom Vercauteren, Senior Lecturer in Interventional Imaging, UCL
    • Dr Rosalind Pratt, Clinical Research Fellow, UCL
    • Katie Konyn, Communications Officers, UCL
    • Beth Dowsett – Marketing Officer, UCL

    Representatives from voluntary organisations:

    • Helen Turier, TAMBA (Twins and Multiple Birth Association) www.tamba.org.uk/
    • Gill King, ARC, (Antenatal Results and Choices) www.arc-uk.org
    • Beverley Power, CDH UK (The Congenital Diaphragmatic Hernia Charity) www.cdhuk.org.uk/
    • James Power, CDH UK
    • Gillian Yaz, Shine charity (Spina Bifida and Hydrocephalus charity) http://www.shinecharity.org.uk/

    At this meeting Prof Jan Deprest gave a presentation discussing considerations in implementation of innovative fetal surgery. He discussed how surgical procedures have been developed in the lab, using animal models of disease, and then how these have been transferred into clinical practice in humans. He also discussed the concepts, which are seen as mandatory in fetal therapy:

    • Prenatal diagnosis must be possible and the natural history of the condition in question must be known
    • Treatment cannot wait until after birth
    • Surgery should be performed on an experimental basis – so as to improve our understanding of the disease and the outcomes of surgery
    • Multidisciplinary team must be familiar with the disease and therapy e.g., the obstetric doctors, the midwives, the paediatricians etc

    He used congenital diaphragmatic hernia as a case study, explaining the disease, the development of treatment in animal models then humans, and finally the on-going clinical trail (http://www.totaltrial.eu/?id=9) which is designed to evaluate the procedures effectiveness at treating the condition.

    Prof Deprest also discussed the considerations involved in creating a website for the trial, and how this was done to maximise the information available to patients, and attempt to minimise biased or pressure on parents to accept treatment.

    The group discussed issues on consent, and how difficult it is to give parents reliable information when fetal therapy is so new, and there remain many uncertainties on outcome. The group discussed how this could be improved.

    The group then had a tour of the lab, and were shown some of the technology being developed.

    18th April 2016

    Present: 

    Clinicians and academics 

    • Dr Anna David, Associate Professor in Obstetrics and Maternal/Fetal Medicine, UCL (Chair)
    • Prof Jan Deprest, Professor of Obstetrics and Gynaecology, KUL, Consultant Obstetrician and Gynaecologist, UZ Leuven
    • Prof Richard Ashcroft, Professor of Bioethics, Queen Mary University of London
    • Caspar Gruikthuijsen, Research Associate, KUL
    • Dr Emmanuel Vander Poorten, Technical Manager, KUL
    • Dr Rosalind Pratt, Clinical Research Fellow, UCL
    • Katie Konyn, Communication Officer, UCL
    • Niamh Ryan, Marketing Officer, UCL

    Representatives from voluntary organisations: 

    • Helen Turier, TAMBA (Twins and Multiple Birth Association) www.tamba.org.uk/
    • Mehali Patel, Bliss, www.bliss.org.uk
    • Jane Fisher, ARC, (Antenatal Results and Choices) www.arc-uk.org

    At this meeting Katie Konyn and Jan Deprest discussed the development of promotional material for GIFT-Surg. The discussion focused on producing informative pictures and text to explain the main conditions GIFT-Surg is working on, both for the general public, and for people affected by the conditions that might be invited to join research. The group discussed how the charities could help in their development, and help to get feedback from people who have been affected by the condition, so we can maximize their usefulness. The group came up with a time frame and plan for doing this.

    Dr Emmanuel Vander Poorten and Casper Gruijthuijsen then gave a presentation and demonstration of the technology they are developing to help fetal surgeons perform complex surgeries. They explained that the advantages of robotic surgery include shorter learning curve for the surgeon, overcoming limitations of minimally invasive surgery, and improving human capabilities. The group discussed how the public might react to robotic surgery, with the general consensus being that people would be happy with the technological development as long as it was explained clearly, and the surgeon was confident about the technology. Dr Emmanuel Vander Poorten talked about risk analysis, as an important step in any technological development, to ensure their systems will be safe to translate into clinical use.