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19/95 Solid organ replacement, transplant and donation commissioning brief

 

Contents

Summary
The National Institute for Health Research (NIHR) is interested in receiving research proposals from the community that will overcome barriers and challenges to organ donation and transplantation, specifically SOLID organ donation and transplantation of those organs that are included on a donor card; heart, lungs, cornea, liver, pancreas, small bowel, tissue, kidneys, and bone.

Applications focused on blood and stem cell studies would be considered out of remit for this particular call and should be submitted to the researcher-led workstreams of the participating programmes. 

Given the scope of this call, we would welcome applications that span the remit of one or more of the participating research programmes and which comprise of co-ordinated teams of investigators spanning different specialties/disciplines and geographical centres.  

We expect to receive applications that are co-produced, demonstrating an equal partnership with service commissioners, providers and service users in order to provide evidence and actionable findings of immediate utility to decision-makers and service users. Applicants may wish to consult the NIHR INVOLVE guidance on co-producing research.


Deadline for proposals:

The deadline for stage 1 applications is 1pm Wednesday 27 November 2019

A webinar to support applicants will be held on Thursday 12 September 2019 at 2:30pm, potential attendees should register their interest at the following email address crossprogramme@nihr.ac.uk. For support developing applications, applicants are also encouraged to contact their local NIHR Research Design Service (RDS) or equivalent in the first instance.  


Supporting Information

An NHS Blood and Transplant report stated that in 2018 there were over 6,000 people on the transplant waiting list and 3,404 people suspended from the waiting list due to ill health. A further 1,166 people died due to a lack of available organs. The report also highlighted further challenges. The donor characteristics are changing over time, with the average donor age and co-morbidities increasing. The report also highlighted that people from black, Asian and ethnic minority communities are more likely to need a kidney transplant. However, the donor consent rate in these communities is very low in comparison to the white population. This means that they wait on average 6 months longer for a kidney transplant and are more likely to suffer complications and graft failure. Whilst solid organ transplantation is expensive, long term it not only saves the NHS money (economic analysis estimates this saving could be as much as £316 million per year), it also improves the length and quality of organ recipient lives. Last year, over 5,000 people received an organ transplant thanks to the generosity of 1,574 deceased donors and a further 1,051 living donors.

Organ donation is the giving of an organ to someone else who needs a transplant. There are different ways in which to donate including;

  • Donation following brain-stem death (DBD). This occurs when a person is diagnosed as dead according to neurological criteria
  • Donation following circulatory death (DCD). This is when a person has had a cardiac arrest and suffered irreversible loss of function of the heart and lungs
  • Living donation, such as a kidney, a part of liver, lung

According to the NIHR Blood and Transplant Research Unit (BTRU) the largest number of transplants that take place are for kidneys, most of which are from living donors. This means that all matching, planning and tissue typing can be done in advance. For deceased organ donation, timescales are tight which means that tissue typing etc. is more time pressured. Successful transplant is therefore more challenging for these organs.

Organ donation after death most commonly occurs following brain-stem death, which happens at a very low rate. This is felt to be due to clinical decisions to withdraw treatments before brain-stem death has occurred, can be diagnosed, or has even been tested. DCD can occur after an unexpected cardiac arrest (this is not generally supported as a source of organ donation in the UK) or after an expected cardiac arrest occurring after the planned withdrawal of treatment that is not deemed to be beneficial to a critically ill patient. There are a high rate of the latter form of DCDs in the UK, though this is often a complex situation as the suitability assessments impose time delays which are often unacceptable to the patient’s family. Consequently, these donors may not always be identified and referred. Living donation is felt to be an innovative and progressive area which contributes to 35% of overall transplants made, and the majority of these are kidney donations (97%).

The 2010–14 Strategy for Living Donor Kidney Transplantation (LDKT) aimed to promote increases in living donation by improving the safety and sustainability of the UK LDKT programme. The new report ‘Living Donor Kidney Transplantation 2020: A UK Strategy’ aims to further this work by matching world class performance in this area; 26 LDKTs per million population. They plan to do this by increasing LDKT activity, maximising patient benefit, and also maximising the opportunities for donors and recipients to contribute and receive. Increasing the rate of LKDTs will benefit not only the patients and families, but also the NHS as more people will be transplanted before needing kidney dialysis.

In order to improve deceased donor rates, there has been a push by NHS Blood and Transplant (NHSBT) to make amendments to improve organ donation rates, particularly where the individual has stated their wish to be an organ donor. The Organ Donation Taskforce report (Organs for Transplant, January 2008) reviewed end-of-life care practices in the UK, made recommendations to improve organ donation and resulted in some positive changes that have increased the transplant rate. In the new report, ‘Taking Organ Transplantation to 2020: A detailed strategy’ they state that ‘despite these improvements, there are still not enough donated organs to meet the current need.’ 


Specific areas of interest for research
For the purposes of this call, seven broad themes have been described below with examples of particular areas of interest for research. However, these are examples and do not represent an exhaustive list.

Applicants should also consider the following:

  • The ethical and consent issues involved and how these will be addressed.
  • Equity of access to both donation of organs and transplantation of organs across different patient groups, including for example ethnicity, gender, cultural beliefs and geographical distribution of disease burden.
  • The potential impact on health inequalities.
  1. Donor and organ assessment:
    This would include objective and quantitative biomarkers that improve the assessment of donor and organ quality and are likely to improve transplantation success and recipient outcomes, as well as alternative service delivery models for such assessments.
  2. Donor management:
    Interventions / technologies in donors which are initiated prior to organ retrieval to optimise organ quality and transplant recipient outcomes are of interest, as are alternative service models for delivering donor management, including for example (but not exclusively) the role of donor assessment centres.
  3. Organ and donor perfusion 
    These include perfusion technologies applied either to donors or individual organs during organ retrieval to optimise organ quality and hence transplant recipient outcomes.
  4. Transplantation
    Technologies or interventions employed during the surgical transplantation of solid organs likely to enhance the surgical success of the transplant and with improved recipient outcomes. 
  5. Post-transplant care
    Technologies or interventions designed to optimise the longevity and function of transplanted organs and hence organ recipient quality of life, including alternative service models for delivery, are of interest.
  6. “Next wave” of transplantation  
    This could include technologies which may impact upon transplantation in the longer-term, for example (but not exclusively) cellular therapies for reducing rejection, xeno-transplantation and 3D-printing of organs, as well as alternative service delivery models.  


How to apply & supporting information:

The Programmes involved in this call are:

Applicants should note that:

  • Proposals must be within the remit of at least one participating NIHR Programme. However, we expect to receive applications which span the remit of one or more programme. To enable applications to be written without concern for individual programme remits or boundaries, applications will be submitted to one cross programme team, rather than to individual programmes.
  • Patient and public involvement must be included within the application and study design to ensure the research is relevant and appropriate to patients and the public.
  • Ambitious applications consisting of more than one clearly linked work package as well as applications for individual studies will be welcomed. We would also encourage the building of research capacity through the research process. 
  • The participating NIHR programmes fund rigorous, problem-focused research to assess the impact of existing health technologies. Applicants must demonstrate that the proposed methodology is appropriate and robust, with consideration given to methodological limitations. 
  • Applicants should clearly state how their proposed research addresses an explicit evidence gap and how the research adds value to the existing NIHR research portfolio.
  • This call represents an ongoing area of interest for the NIHR and following this opportunity, the NIHR research programmes would still be interested in receiving applications in this area to their researcher-led workstreams. 

Contact Information
General questions about the call should be addressed to your local RDS in the first instance or further guidance may be obtained by sending a short summary (max 1 A4 page) of their research proposal, in a structured format including rationale, research question, proposed methodology and outcome/evaluation methods to the following address: crossprogramme@nihr.ac.uk.