The CKD Bowel Health Study

In patients with chronic kidney disease, we will observe the prevalence and risk factors of gastrointestinal intolerance before and after kidney transplantation. The duration of the observation will be anytime before transplantation, then 4, 12, and 28 weeks post-transplantation. Adults aged 18 years and older. Patients with kidney failure (CKD Stage 4 to 5D: estimated Glomerular Filtration Rate = 0 to 29 mL/min/1.73m2 and albuminuria > 300 mg/g) on dialysis listed on the deceased donor kidney transplant waiting list, or patients with kidney failure with a planned pre-emptive transplant within 12 months. This includes both kidney-only and simultaneous pancreas-kidney transplant candidates. Three sub-studies will be undertaken as follows: Study 1. An observational longitudinal study of the burden and risk factors of GI intolerance in kidney transplant candidates (patients with kidney failure on dialysis and are eligible for transplantation) and in kidney transplant recipients. General patient contact information, demographic characteristics, medical history, and CKD health status will be collected via the Demographics Questionnaire. The baseline assessments, pre-transplant of observational data will be collected via the Observational Questionnaire (Baseline): which will collect transplant status, current medications and supplements, general health via the EQ-5D Questionnaire, faecal characteristics using the Bristol Stool Chart, gastrointestinal symptoms via the Gastrointestinal Symptom Rating Scale (GSRS), quality of life using the Gastrointestinal Quality of Life Scale (GIQLS), personal management strategies of gut health and GI symptoms, dietary patterns using the Food Frequency Questionnaire (FFQ), and safety parameters and adverse events. To repeat the instruments, the Observational Questionnaire (Follow-Up) will be repeated as the same form and administered at 4, 12, and 28 weeks post-transplant (28 weeks being the final follow-up time-points). This questionnaire contains the same instruments without the patient contact information and demographic sections. It will be administered by the study researcher face-to-face in clinic at usual visits, or completed by the patient at home where language and literacy skills are competent. The Observational Questionnaire takes approximately 30-60 minutes to complete. Study 2. A semi-structured qualitative interview study in kidney transplant candidates and kidney transplant recipients. (A subset of the first 20 participants to agree will be selected from the Observational Study 1). A semi-structured face-to-face interview will be conducted with each participant in their choice of either in a clinic room or via video conference. The interviews will be administered by the study research personnel who are research academics with training in qualitative research. Some participants may be known to the interviewers but only from the recruitment process. Neither interviewer will have clinically treated the participants. The Qualitative Interview Guide includes the following sections: Demographics Interview 1: general perspectives and experience of gut health in CKD; perceived causes, impact and management of GI symptoms in CKD; expectations of transplantation; reasons for participating in the study; Interview 2: experience of being in the study; experience of the transplant; experience of GI symptoms post-transplant The guide was developed following a review of the literature and discussion among the research team consisting of nephrologists and public health (qualitative) academics. Schedule: Participants will be interviewed twice: once at baseline (anytime pre-transplant) (Visit 1) and once post-transplant at the 28-week follow-up (Visit 4). These will be approximately 30-45 minutes long. Study 3. A discrete choice experiment of patient preferences regarding the perspectives of the different treatment and intervention strategies for the management of GI symptoms in patients with kidney transplants. All participants from study 1 will be approached to participate. (Options will be based on the outcomes of Study 2. Participant will be selected from the Observational Study 1, but also new recruits of kidney transplant recipients). At either Visit 3 or Visit 4, or anytime within 4 months post-transplant, participants will be administered the electronic Discrete Choice Experiment Survey (NGENE Software) directly after attending their usual medical appointment with their surgeon using a clinic computer. Participants will be identified by their name and participant study ID which will be linked to their baseline information. Demographics will have already been taken in Study 1. The survey will be administered as follows: (1) instructions and introduction of the study aim, (2) explanation of attributes, (3) explanation of choice sets. In the Discrete Choice Experiment Survey, participants will be given 5 to 10 choice sets to answer their most preferred scenario of post-transplant treatment options. The anticipated survey time is approximately 5-10 minutes. The attributes are: mode of taking supplements; average cost per month; access to supplements; dietary changes; post-transplant prescribed immunosuppressive medications. The survey was developed following a review of the literature and discussion among the research team consisting of nephrologists and public health (qualitative) academics.