Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small to detect treatment effects of a magnitude that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled "Challenges in the Conduct of Clinical Trials in Nephrology" to identify the key barriers to conducting trials in patients with kidney disease. The conference began with plenary talks focusing on the key areas of discussion that included appropriate trial design (covering identification and evaluation of kidney and nonkidney disease outcomes) and sensible trial execution (with particular emphasis on streamlining both design and conduct). Break out group discussions followed in which the key areas of agreement and remaining controversy were identified. Here we summarize the main findings from the conference and set out a range of potential solutions. If followed, these solutions could ensure future trials among people with kidney disease are sufficiently robust to provide reliable answers and are not constrained by inappropriate complexities in design or conduct.

BackgroundIt has been suggested that the research priorities of those funding and performing research in transplantation may differ from those of end service users such as patients, carers and healthcare professionals involved in day-to-day care. The Kidney Transplant Priority Setting Partnership (PSP) was established with the aim of involving all stakeholders in prioritising future research in the field.MethodsThe PSP methodology is as outlined by the James Lind Alliance. An initial survey collected unanswered research questions from patients, carers and clinicians. Duplicate and out-of-scope topics were excluded and the existing literature searched to identify topics answered by current evidence. An interim prioritisation survey asked patients and professionals to score the importance of the remaining questions to create a ranked long-list. These were considered at a final consensus workshop using a modified nominal group technique to agree a final top ten.ResultsThe initial survey identified 497 questions from 183 respondents, covering all aspects of transplantation from assessment through to long-term follow-up. These were grouped into 90 unanswered “indicative” questions. The interim prioritisation survey received 256 responses (34.8% patients/carers, 10.9% donors and 54.3% professionals), resulting in a ranked list of 25 questions that were considered during the final workshop. Participants agreed a top ten priorities for future research that included optimisation of immunosuppression (improved monitoring, choice of regimen, personalisation), prevention of sensitisation and transplanting the sensitised patient, management of antibody-mediated rejection, long-term risks to live donors, methods of organ preservation, induction of tolerance and bioengineering of organs. There was evidence that patient and carer involvement had a significant impact on shaping the final priorities.ConclusionsThe final list of priorities relates to all stages of the transplant process, including access to transplantation, living donation, organ preservation, post-transplant care and management of the failing transplant. This list of priorities will provide an invaluable resource for researchers and funders to direct future activity.

BackgroundConservative kidney management (CKM) is recognised as an alternative to dialysis for a significant number of older adults with multimorbid stage 5 chronic kidney disease (CKD5). However, little is known about the way CKM is delivered or how it is perceived.AimTo determine the practice patterns for the CKM of older patients with CKD5, to inform service development and future research.Objectives(1) To describe the differences between renal units in the extent and nature of CKM, (2) to explore how decisions are made about treatment options for older patients with CKD5, (3) to explore clinicians’ willingness to randomise patients with CKD5 to CKM versus dialysis, (4) to describe the interface between renal units and primary care in managing CKD5 and (5) to identify the resources involved and potential costs of CKM.MethodsMixed-methods study. Interviews with 42 patients aged > 75 years with CKD5 and 60 renal unit staff in a purposive sample of nine UK renal units. Interviews informed the design of a survey to assess CKM practice, sent to all 71 UK units. Nineteen general practitioners (GPs) were interviewed concerning the referral of CKD patients to secondary care. We sought laboratory data on new CKD5 patients aged > 75 years to link with the nine renal units’ records to assess referral patterns.ResultsSixty-seven of 71 renal units completed the survey. Although terminology varied, there was general acceptance of the role of CKM. Only 52% of units were able to quantify the number of CKM patients. A wide range reflected varied interpretation of the designation ‘CKM’ by both staff and patients. It is used to characterise a future treatment option as well as non-dialysis care for end-stage kidney failure (i.e. a disease state equivalent to being on dialysis). The number of patients in the latter group on CKM was relatively small (median 8, interquartile range 4.5–22). Patients’ expectations of CKM and dialysis were strongly influenced by renal staff. In a minority of units, CKM was not discussed. When discussed, often only limited information about illness progression was provided. Staff wanted more research into the relative benefits of CKM versus dialysis. There was almost universal support for an observational methodology and a quarter would definitely be willing to participate in a randomised clinical trial, indicating that clinicians placed value on high-quality evidence to inform decision-making. Linked data indicated that most CKD5 patients were known to renal units. GPs expressed a need for guidance on when to refer older multimorbid patients with CKD5 to nephrology care. There was large variation in the scale and model of CKM delivery. In most, the CKM service was integrated within the service for all non-renal replacement therapy CKD5 patients. A few units provided dedicated CKM clinics and some had dedicated, modest funding for CKM.ConclusionsConservative kidney management is accepted across UK renal units but there is much variation in the way it is described and delivered. For best practice, and for CKM to be developed and systematised across all renal units in the UK, we recommend (1) a standard definition and terminology for CKM, (2) research to measure the relative benefits of CKM and dialysis and (3) development of evidence-based staff training and patient education interventions.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

Background and objectives Conservative kidney management (CKM) has been developed in the United Kingdom (UK) as an alternative to dialysis for older patients with stage 5 CKD (CKD5) and multiple comorbidities. This national survey sought to describe the current scale and pattern of delivery of conservative care in UK renal units and identify their priorities for its future development.Design, setting, participants, & measurements A survey on practice patterns of CKM for patients age 75 and older with CKD5 was sent to clinical directors of all 71 adult renal units in the UK in March 2013.Results Sixty-seven units (94%) responded. All but one unit reported providing CKM for some patients. Terminology varied, although "conservative management" was the most frequently used term (46%). Lack of an agreed-upon definition of when a patient is receiving CKM made it difficult to obtain meaningful data on the numbers of such patients. Fifty-two percent provided the number of CKM patients age $75 years in 2012; the median was 45 per unit (interquartile range [IQR], 20-83). The median number of symptomatic CKM patients who would otherwise have started dialysis was eight (IQR,. CKM practice patterns varied: 35% had a written guideline, 23% had dedicated CKM clinics, 45% had dedicated staff, and 50% provided staff training on CKM. Most units (88%) provided primary care clinicians with information/advice regarding CKM. Eighty percent identified a need for better evidence comparing outcomes on CKM versus dialysis, and 65% considered it appropriate to enter patients into a randomized trial.Conclusions CKM is provided in almost all UK renal units, but scale and organization vary widely. Lack of common terminology and definitions hinders the development and assessment of CKM. Many survey respondents expressed support for further research comparing outcomes with conservative care versus dialysis.

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