Patient-reported outcomes of CKD and diabetes treatments (version 1.1)
Research type
Research Study
Full title
Patient-reported outcomes of chronic kidney disease and diabetes treatments, including transplantation.
IRAS ID
240896
Contact name
Clare Bradley
Contact email
Sponsor organisation
Royal Holloway, University of London
Duration of Study in the UK
2 years, 4 months, 4 days
Research summary
Summary of Research
Simultaneous pancreas and kidney (SPK) transplantation is commonly considered by transplant surgeons to be the best treatment for patients with insulin-dependent diabetes and stage 5 chronic kidney disease (CKD). However, there is little research on patient-reported outcomes (PROs), such as quality of life (QoL), with this group of patients. A previous study called ‘Access to Transplantation and Transplant Outcome Measures’ (ATTOM) investigated PROs of patients receiving a range of treatments for renal failure. PRO data was collected from a small number of patients pre- and post-SPK transplantation as well as from those who remained on the waiting list over a 12 month period. There were some important differences at recruitment in those who went on to have a transplant and those who remained wait-listed, showing that it is important to follow-up patients over time rather than compare different pre- and post-transplant groups.
The current research aims to collect prospective PROs data from a larger new patient cohort to provide further insight into how SPK transplantation affects outcomes such as QoL. Patients wait-listed for an SPK transplant will be recruited from 3 UK transplant units (Cambridge, London and Edinburgh) over a 12-15 month period. Clinic staff will provide interested patients with an information sheet, consent form and a set of questionnaires. After completion, patients will return the questionnaire pack to the researchers at Royal Holloway, University of London. Further questionnaires will be sent 6 and 12 months later to patients remaining on the waiting list and 12 months after transplantation. A subset of patients and some patients’ partners will be interviewed about their experiences of wait-listing and SPK transplantation.
The findings from the study will help in advising patients on how transplantation affects QoL and other outcomes, and which patients are likely to gain most or least from transplantation.
Summary of Results
Thirty-four people on the waiting list for a simultaneous pancreas and kidney transplant (SPKT) were recruited and 20 participants completed follow-up questionnaires 12-months post-recruitment (n = 9) or post-transplant (n = 11). Telephone interviews with 12 participants were also conducted to explore responses given on the measures of quality of life and their experiences with diabetes, CKD, and transplantation. Telephone interviews were also carried out with five partners of SPKT recipients to gain an understanding of their personal experiences and the wider impact of SPK transplantation on patients’ families.
The study results suggest that SPK transplantation was beneficial. Patients were less negatively impacted by diabetes post-transplant compared to pre-transplant. Quality of life, treatment satisfaction, perceived health status, and well-being all improved from pre- to post-transplant. SPKT recipients had greater treatment satisfaction than people who were still waiting for a transplant.
The interviews found that diabetes management was often a struggle and/or invasive, and the combination of CKD and diabetes was restrictive. SPKT recipients were very positive about transplantation and indicated they had more freedom. However, some still experienced issues post-transplant. For example, some continued to be impacted by health issues, such as eyesight problems, and/or new issues post-transplant. In particular, restrictions of the Covid-19 pandemic impacted patients’ quality of life. This could also help to explain why significant improvements in renal-dependent quality of life were not found.
The interviews with partners found that they often felt a responsibility to take care of the person with diabetes and CKD. Partners reported considerable worry prior to their partner’s transplant, but a great sense of relief post-transplant. Partners also felt that they had more freedom post-transplant (or were hopeful that they would experience a greater sense of freedom once pandemic restrictions were lifted).
The research highlights the wider benefit of transplantation, to both patients and their partners. The findings illustrate that although SPK transplantation is beneficial, some patients and partners may need more support throughout the transplantation process. Patients and their families need to be well informed on how to access support and encouraged to use available support.
We would like to thank the participants for giving up their time to take part in the research. We would also like to thank the renal unit staff members who helped with recruitment to the study.
REC name
London - Queen Square Research Ethics Committee
REC reference
18/LO/0134
Date of REC Opinion
20 Mar 2018
REC opinion
Further Information Favourable Opinion