The CKD bowel health study: understanding the bowel health and gastrointestinal symptom management in patients with chronic kidney disease: a mixed-methods observational longitudinal study (protocol)

Abstract

Background Gastro-intestinal (GI) intolerance is a frequently reported outcome in patients with kidney failure receiving maintenance dialysis and those who have received kidney transplants. Symptoms of GI intolerance (diarrhoea, constipation, bloating, abdominal pain, heart burn, and reflux) are associated with significant reduction in quality of life, morbidity, and increased used of healthcare resources. Having chronic kidney disease (CKD), together with related changes in diet and medication, may alter the gut microbiota and the microbial-derived uraemic metabolites that accumulate in kidney failure, and contribute to various complications including chronic diarrhoea, opportunistic infections, and drug-related colitis. Despite the high disease burden among patients with kidney replacement therapies, GI symptoms are often under-recognised and, consequently limited resources and strategies are devoted to the management of gastrointestinal complications in patients with CKD. Methods The CKD Bowel Health Study is a multi-centre mixed-methods observational longitudinal study to better understand the bowel health and GI symptom management in patients with CKD. The program comprises of a longitudinal study that will assess the burden and risk factors of GI intolerance in patients treated with maintenance dialysis; a semi-structured interview study that will describe experiences of GI intolerance (including symptoms, treatment, self-management) in transplant candidates and recipients; and a discrete choice experience to elicit patient preferences regarding their experiences and perspectives of various intervention strategies for the management of GI symptoms after kidney transplantation. Discussion This proposed program of work aims to define the burden the GI intolerance in patients with kidney failure and generate evidence on the patients’ experiences of GI intolerance and their perspectives on their clinical and own management strategies of these symptoms, ensuring a patient-centred approach to guide clinical decision making and to inform the best study design for intervention trials. Trial registration This study is registered on the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000548831. This study has been approved by the Western Sydney Local Health District Human Research Ethics Committee of New South Wales Health (HREC ETH03007). This study is supported by a National Health and Medical Research Council (NHMRC) Australia Investigator Grant (APP1195414), and an NHMRC Australia Postgraduate Scholarship (APP2005244).

Prevalence and Severity of Lower Gastrointestinal Symptoms amongst Non-Dialysis Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis

“…This will include broader search methods to include areas not fully covered in this review and will take advantage of emerging methods for meta-analyses. We anticipate the results of a study currently occurring in Uganda [ 90 ], and also one in Australia [ 91 ], and a full-text article detailing data for non-dialysis CKD patients from a study conducted in Malaysia [ 92 ]. Moreover, we will update the meta-analytical methods to provide results that are as reliable as possible.…”

Patient Preferences for the Management of Gastrointestinal Symptoms in Kidney Transplantation: a Discrete Choice Experiment

“…This study is registered on the Australian New Zealand Clinical Trials Registry: ACTRN12621000548831, published in our protocol, 8 and has been approved by the Western Sydney Local Health District Human Research Ethics Committee of New South Wales Health (HREC ETH03007). This study is developed and reported in accordance with the reporting checklist for observational studies (STROBE) 9 ( Supplementary Table S1 ).…”

“…The survey was developed following a review of the literature, in-depth collaboration with consumer partners, discussion among the research team (consisting of clinicians and researchers), and preliminary qualitative interviews (semistructured in-depth qualitative interviews 8 ) with patients and consumers to ensure the inclusion of a broad range of relevant, clinically important and patient-important outcomes, symptoms and management characteristics of cost, formulation, diet changes, GI symptoms, and medications. 14 , 15 , 16 , 17 , 18 After the survey was developed, it was piloted with our consumer partners to ensure face and content validity.…”

“…The a priori published protocol has undergone full external peer review was part of the funding application process. 8 The funding body plays no role in the design of the study, collection, analysis, and interpretation of the data, or in writing the manuscript.…”