Outcomes for clinical trials involving adults with chronic kidney disease: a multinational Delphi survey involving patients, caregivers and health professionals.

BACKGROUND: Many outcomes of high priority to patients and clinicians are infrequently and inconsistently reported across trials in chronic kidney disease (CKD), which generates research waste and limits evidence-informed decision making. We aimed to generate consensus among patients/caregivers and health professionals on critically important outcomes for trials in CKD prior to kidney failure and the need for kidney replacement therapy, and to describe the reasons for their choices. METHODS: This was an online two-round international Delphi survey. Adult patients with CKD (all stages and diagnoses), caregivers and health professionals who could read English, Spanish or French were eligible. Participants rated the importance of outcomes using a Likert scale (7-9 indicating critical importance) and a Best-Worst Scale. The scores for the two groups were assessed to determine absolute and relative importance. Comments were analysed thematically. RESULTS: In total, 1399 participants from 73 countries completed Round 1 of the Delphi survey, including 628 (45%) patients/caregivers and 771 (55%) health professionals. In Round 2, 790 participants (56% response rate) from 63 countries completed the survey including 383 (48%) patients/caregivers and 407 (52%) health professionals. The overall top five outcomes were: kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death. In the final round, patients/caregivers indicated higher scores for most outcomes (17/22 outcomes), and health professionals gave higher priority to mortality, hospitalization and cardiovascular disease (mean difference >0.3). Consensus was based upon the two groups yielding median scores of ≥7 and mean scores >7, and the proportions of both groups rating the outcome as 'critically important' being >50%. Four themes reflected the reasons for their priorities: imminent threat of a health catastrophe, signifying diminishing capacities, ability to self-manage and cope, and tangible and direct consequences. CONCLUSION: Across trials in CKD, the outcomes of highest priority to patients, caregivers and health professionals were kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death.

Peritoneal Dialysis Care for People with Diabetes, Polycystic Kidney Disease, or Advanced Liver Disease.

People treated with peritoneal dialysis (PD) often have complicating conditions that require careful management. Three such conditions are reviewed in this article-diabetes mellitus, polycystic kidney disease, and chronic liver disease. Each of these conditions requires an understanding of both its effect on the delivery of the PD and the effect of the PD on the condition itself. In diabetes, glucose absorption from the dialysate complicates metabolic control and affects salt and water management and patient outcome. There is particular benefit in clinical care being delivered through a multidisciplinary team that involves both kidney and diabetes experts. In relation to polycystic kidney disease, a key issue is the potential for increased intraperitoneal pressure due to the combined effect of the enlarged polycystic organs and the presence of the dialysis solution, and therefore, the PD prescription requires to be managed with a particular focus on limiting that pressure. For patients with liver disease, key issues include nutritional support because PD can add to protein losses already consequent on the liver disease itself. Considered approaches are required to manage ascites and reduce infection risk and the potential for hernias and leaks to develop. Mortality in this group is unfortunately high-however, PD may present a better management option than hemodialysis in many patients-particularly in those where the liver disease is complicated by low BP, clotting abnormalities, or troublesome ascites. Overall, the choice to use PD in patients with these complicating conditions should be based on shared decision making with the patient and their family members informed by high-quality information in which risks, benefits, and management strategies are clearly presented.

Supporting patient self-management: A cross-sectional and prospective cohort study investigating Patient Activation Measure (PAM) and Clinician Support for PAM scores as part of a multi-centre haemodialysis breakthrough series collaborative.

BACKGROUND: Patient self-management, measured by the Patient Activation Measure (PAM), is associated with reduced healthcare utilisation and better health-related quality of life. Self-management in haemodialysis (HD) is challenging and may require support from clinicians with positive attitudes towards self-management, measured by the Clinician Support for PAM (CSPAM). OBJECTIVES: To assess whether kidney staff CSPAM scores are: 1) associated with their centre's patient PAM scores and 2) modifiable through staff coaching. METHODS: Baseline PAM and CSPAM and six-month CSPAM were collected from HD patients and kidney staff respectively in seven UK kidney centres as part of a six-month breakthrough series collaborative (BTSC), which trained kidney staff in supporting patient independence with HD tasks. Firstly, multivariable linear regression analyses adjusted for patient characteristics were used to test the baseline association between centre-level staff CSPAM scores and patient PAM scores. Secondly, paired univariate and unpaired multivariable linear regression analyses were conducted to compare staff CSPAM scores at baseline and six months. RESULTS: 236 PAM questionnaires (mean score = 55.5) and 89 CSPAM questionnaires (median score = 72.6) were analysed at baseline. There was no significant association between centre-level mean CSPAM scores and PAM scores in univariate analyses (P = 0.321). After adjusting for patient-level characteristics, increasing centre-level mean CSPAM score by 1 point resulted in a non-significant 0.3-point increase in PAM score (0.328 (95% CI: -0.157 to 0.812; P = 0.184). Paired (n = 37) and unpaired (n = 174) staff analyses showed a non-significant change in CSPAM scores following the BTSC intervention (mean change in CSPAM score in unpaired analysis = 1.339 (95% CI: -1.945 to 4.623; P = 0.422). CONCLUSIONS: Lack of a significant: 1) association between CSPAM and PAM scores and 2) change in CSPAM scores suggest that modifying staff beliefs alone is less likely to influence patient self-management, requiring co-production between patients and staff.

Getting the most out of remote care: Co-developing a Toolkit to improve the delivery of remote kidney care appointments for underserved groups.

BACKGROUND: Telephone and video appointments are still common post-pandemic, with an estimated 25%-50% of kidney appointments in the United Kingdom still conducted remotely. This is important as remote consultations may exacerbate pre-existing inequalities in those from underserved groups. Those from underserved groups are often not represented in health research and include those with learning disability, mental health needs, hearing/sight problems, young/older people, those from ethnic minority groups. OBJECTIVES: The aim was to develop a Toolkit to improve the quality of remote kidney care appointments for people from different underserved groups. DESIGN: A parallel mixed methods approach with semistructured interviews/focus groups and survey. We also conducted workshops to develop and validate the Toolkit. PARTICIPANTS: Seventy-five renal staff members completed the survey and 21 patients participated in the interviews and focus groups. Patients (n = 11) and staff (n = 10) took part in the Toolkit development workshop, and patients (n = 13) took part in the Toolkit validation workshop. RESULTS: Four themes from interviews/focus groups suggested areas in which remote appointments could be improved. Themes were quality of appointment, patient empowerment, patient-practitioner relationship and unique needs for underserved groups. Staff reported difficulty building rapport, confidentiality issues, confidence about diagnosis/advice given, technical difficulties and shared decision making. CONCLUSION: This study is the first to explore experiences of remote appointments among both staff and those from underserved groups living with kidney disease in the United Kingdom. While remote appointments can be beneficial, our findings indicate that remote consultations need optimisation to meet the needs of patients. The project findings informed the development of a Toolkit which will be widely promoted and accessible in the United Kingdom during 2024.

Nephrologists' perspectives on communication and decision-making regarding technique survival in peritoneal dialysis: an international qualitative interview study.

OBJECTIVES: Peritoneal dialysis (PD) allows patients increased autonomy and flexibility; however, both infectious and non-infectious complications may lead to technique failure, which shortens treatment longevity. Maintaining patients on PD remains a major challenge for nephrologists. This study aims to describe nephrologists' perspectives on technique survival in PD. DESIGN: Qualitative semistructured interview study. Transcripts were thematically analysed. SETTING AND PARTICIPANTS: 30 nephrologists across 11 countries including Australia, the USA, the UK, Hong Kong, Canada, Singapore, Japan, New Zealand, Thailand, Colombia and Uruguay were interviewed from April 2017 to November 2019. RESULTS: We identified four themes: defining patient suitability (confidence in capacity for self-management, ensuring clinical stability and expected resilience), building endurance (facilitating access to practical support, improving mental well-being, optimising quality of care and training to reduce risk of complications), establishing rapport through effective communications (managing expectations to enhance trust, individualising care and harnessing a multidisciplinary approach) and confronting fear and acknowledging barriers to haemodialysis (preventing crash landing to haemodialysis, facing concerns of losing independence and positive framing of haemodialysis). CONCLUSION: Nephrologists reported that technique survival in PD is influenced by patients' medical circumstances, psychological motivation and positively influenced by the education and support provided by treating clinicians and families. Strategies to enhance patients' knowledge on PD and communication with patients about technique survival in PD are needed to build trust, set patient expectations of treatment and improve the process of transition off PD.

Novel Colorimetric and Light Scatter Methods to Identify and Manage Peritoneal Dialysis-Associated Peritonitis at the Point-of-Care.

Introduction: Peritoneal dialysis (PD)-related peritonitis (PDRP) is a common cause of transfer to hemodialysis, patient morbidity, and is a risk factor for mortality. Associated patient anxiety can deter selection of PD for renal replacement therapy. Diagnosis relies on hospital laboratory tests; however, this might be achieved earlier if such information was available at the point-of-care (POC), thereby significantly improving outcomes. The presence of culturable microbes and the concentration of leukocytes in effluent both aid peritonitis diagnosis, as specified in the International Society for Peritoneal Dialysis (ISPD) diagnostic guidelines. Here, we report the development of 2 new methods providing such information in simple POC tests. Methods: One approach uses a tetrazolium-based chemical reporting system, primarily focused on detecting bacterial contamination and associated vancomycin-sensitivity. The second approach uses a novel forward light-scatter device (QuickCheck) to provide an instant quantitative cell count directly from PD patient effluent. Results: The tetrazolium approach detected and correctly distinguished laboratory isolates, taking 10 hours to provide non-quantitative results. We compared the technical performance of the light scatter leukocyte counting approach with spectrophotometry, hemocytometer counting and flow cytometry (Sysmex) using patient effluent samples. QuickCheck had high accuracy (94%) and was the most precise (coefficient of variation <4%), showing minimal bias, overall performing similarly to flow cytometry. Conclusion: These complementary new approaches provide a simple means to obtain information to assist diagnosis at the POC. The first provides antibiotic sensitivity following 10 hours incubation, whereas the second optical approach (QuickCheck), provides instant accurate total leukocyte count.

Catheter Event Rates in Medical Compared to Surgical Peritoneal Dialysis Catheter Insertion.

Introduction: How patient, center, and insertion technique factors interact needs to be understood when designing peritoneal dialysis (PD) catheter insertion pathways. Methods: We undertook a prospective cohort study in 44 UK centers enrolling participants planned for first catheter insertion. Sequences of regressions were used to describe the associations linking patient and dialysis unit-level characteristics with catheter insertion technique and their impact on the occurrence of catheter-related events in the first year (catheter-related infection, hospitalization, and removal). Factors associated with catheter events were incorporated into a multistate model comparing the rates of catheter events between medical and surgical insertion alongside treatment modality transitions and mortality. Results: Of 784 first catheter insertions, 466 (59%) had a catheter event in the first year and 61.2% of transitions onto hemodialysis (HD) were immediately preceded by a catheter event. Catheter malfunction was less but infection was more common with surgical compared with medical insertions. Participants at centers with fewer late presenters and more new dialysis patients starting PD, had a lower probability of a catheter event. Adjusting for these factors, the hazard ratio for a catheter event following insertion (medical vs. surgical) was 0.70 (95% confidence interval [CI] 0.43 to 1.13), and once established on PD 0.77 (0.62 to 0.96). Conclusion: Offering both medical and surgical techniques is associated with lower catheter event rates and keeps people on PD for longer.