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IntroductionPeritoneal dialysis (PD)-related peritonitis is one of the leading causes of discontinuation of PD and is considered a critically important outcome for patients on PD. However, there is no universally accepted method of measuring this outcome in clinical trials.MethodsWe convened an online consensus workshop to establish a core outcome measure for PD-related peritonitis in clinical trials.ResultsA total of 53 participants, including 18 patients and caregivers, from 12 countries engaged in breakout discussions in this workshop. Transcripts were analyzed thematically. We identified the following 3 themes: (i) feasibility and applicability across diverse settings, which reflected the difficulty with implementing laboratory-based measures in resource-limited environments; (ii) ensuring validity, which included minimizing false positives and considering the specificity of symptoms; and (iii) being meaningful and tangible to patients, which meant that the measure should be easy to interpret, reflect the impact that symptoms have on patients, and promote transparency by standardizing the reporting of peritonitis among dialysis units.ConclusionA core outcome measure for PD-related peritonitis should include both symptom-based and laboratory-based criteria. Thus, the International Society for Peritoneal Dialysis (ISPD) definition of peritonitis is acceptable. However, there should be consideration of reporting suspected peritonitis in cases where laboratory confirmation is not possible. The measure should include all infections from the time of catheter insertion and capture both the rate of infection and the number of patients who remain peritonitis free. A core outcome measure with these features would increase the impact of clinical trials on the care and decision-making of patients receiving PD.

Patient and caregiver involvement broadens the scope of new knowledge generated from research and can enhance the relevance, quality and impact of research on clinical practice and health outcomes. Incorporating the perspectives of people with lived experience of chronic kidney disease (CKD) affords new insights into the design of interventions, study methodology, data analysis and implementation and has value for patients, healthcare professionals and researchers alike. However, patient involvement in CKD research has been limited and data on which to inform best practice is scarce. A number of frameworks have been developed for involving patients and caregivers in research in CKD and in health research more broadly. These frameworks provide an overall conceptual structure to guide the planning and implementation of research partnerships and describe values that are essential and strategies considered best practice when working with diverse stakeholder groups. This article aims to provide a summary of the strategies most widely used to support multistakeholder partnerships, the different ways patients and caregivers can be involved in research and the methods used to amalgamate diverse and at times conflicting points of view. [ABSTRACT FROM AUTHOR]

Background More than 50% of children with chronic kidney disease (CKD) have uncontrolled hypertension, increasing their long-term risk of cardiovascular disease and progression to kidney failure. Children receiving medications or dialysis may also experience acute blood pressure fluctuations accompanied by debilitating symptoms. We aimed to describe the perspectives of children with CKD and their parental caregivers on blood pressure to inform patient-centered care. Methods Secondary thematic analysis was conducted on qualitative data from the Standardized Outcomes in Nephrology—Children and Adolescents initiative, encompassing 16 focus groups, an international Delphi survey and two consensus workshops. We analyzed responses from children with CKD (ages 8–21 years) and caregivers (of children ages 0–21 years) pertaining to blood pressure. Results Overall, 120 patients and 250 caregivers from 22 countries participated. We identified five themes: invisibility and normalization (reassured by apparent normotension, absence of symptoms and expected links with CKD), confused by ambiguity (hypertension indistinguishable from cardiovascular disease, questioning the need for prophylactic intervention, frustrated by inconsistent messages and struggling with technical skills in measurement), enabling monitoring and maintaining health (gaging well-being and preventing vascular complications), debilitating and constraining daily living (provoking anxiety and agitation, helpless and powerless and limiting life activities) and burden of medications (overwhelmed by the quantity of tablets and distress from unexpected side effects). Conclusions For children with CKD and their caregivers, blood pressure was an important heath indicator, but uncertainty around its implications and treatment hampered management. Providing educational resources to track blood pressure and minimizing symptoms and treatment burden may improve outcomes in children with CKD. [ABSTRACT FROM AUTHOR]

Background: Globally, over 1.2 million people die from chronic kidney disease (CKD) every year. Patients with CKD are up to 10 times more likely to die prematurely than progress to kidney failure requiring kidney replacement therapy. The burden of symptoms and impaired quality of life in CKD may be compounded by comorbidities and treatment side effects. However, patient-important outcomes remain inconsistently and infrequently reported in trials in patients with CKD, which can limit evidence-informed decision-making. The Standardised Outcomes in Nephrology - Chronic Kidney Disease (SONG-CKD) aims to establish a consensus-based core outcome set for trials in patients with CKD not yet requiring kidney replacement therapy to ensure outcomes of relevance to patients, caregivers and health professionals are consistently reported in trials.Methods: SONG-CKD involves four phases: a systematic review to identify outcomes (domains and measures) that have been reported in randomised controlled trials involving adults with CKD who do not require kidney replacement therapy; stakeholder key informant interviews with health professionals involved in the care of adults with CKD to ascertain their views on establishing core outcomes in CKD; an international two-round online Delphi survey with patients, caregivers, clinicians, researchers, policy makers and industry representatives to obtain consensus on critically important outcome domains; and stakeholder consensus workshops to review and finalise the set of core outcome domains for trials in CKD.Discussion: Establishing a core outcome set to be reported in trials in patients with CKD will enhance the relevance, transparency and impact of research to improve the lives of people with CKD.Trial Registration: Not applicable. This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/Studies/Details/1653 . [ABSTRACT FROM AUTHOR]

Background Diminished mental health is associated with increased morbidity and mortality and may contribute to loss of independence and motivation in patients receiving dialysis and their caregivers. Increased understanding of the patient perspective on triggers, impacts and strategies for managing mental health may inform ways to address mental health conditions in this population. Methods A secondary thematic analysis was undertaken using data from the Standardized Outcomes in Nephrology (SONG)-Hemodialysis and SONG-Peritoneal Dialysis projects. We extracted and analysed data on the perceived causes, meaning, impact and management of mental health in patients receiving dialysis from 26 focus groups (in six countries), multinational Delphi surveys and consensus workshops. Results A total of 644 patients and caregivers participated. We identified five themes: bound to dialysis (forced into isolation, enslaved to a machine, stress of relentless planning and grieving the loss of a normal life), underrecognized and ignored (missed by health practitioners, need for mental health support), an uncertain future (dreading complications, coming to terms with mortality), developing self-reliance (vulnerability in being solely responsible for dialysis, sustaining motivation for dialysis, necessity for self-vigilance and taking charge to regulate emotions) and responding to a lifestyle overhaul (guilt of burdening family, controlling symptoms for overall mental wellness, protecting independence and trying to feel grateful). Conclusions Patients receiving dialysis and their caregivers endure mental and emotional distress attributed to the burden of dialysis, lifestyle restrictions, the constant threat of death and symptom burden, which can impair motivation for self-management. Increased attention to monitoring and management of mental health in this population is needed. [ABSTRACT FROM AUTHOR]

Background: Chronic kidney disease (CKD) is a devastating illness associated with increased mortality, reduced quality of life, impaired growth, neurocognitive impairment and psychosocial maladjustment in children. There is growing evidence of socioeconomic disparities in health outcomes among children with CKD. Patient navigators are trained non-medical personnel who assist patients with chronic conditions journey through the continuum of care and transit across different care settings. They help vulnerable and underserved populations to better understand their diagnosis, treatment options, and available resources, guide them through complex medical systems, and help them to overcome barriers to health care access. Given the complexity and chronicity of the disease process and concerns that current models of care may not adequately support the provision of high-level care in children with CKD from socioeconomically disadvantaged backgrounds, a patient navigator program may improve the provision of care and overall health of children with CKD.Methods: The NAV-KIDS2 trial is a multi-centre, staggered entry, waitlisted randomised controlled trial assessing the health benefits and costs of a patient navigator program in children with CKD (stages 3-5, on dialysis, and with kidney transplants), who are of low socioeconomic backgrounds. Across 5 sites, 210 patients aged from 3 to 17 years will be randomised to immediate receipt of a patient navigator intervention for 24 weeks or waitlisting with standard care until receipt of a patient navigator at 24 weeks. The primary outcome is child self-rated health (SRH) 6-months after completion of the intervention. Other outcomes include utility-based quality of life, caregiver SRH, satisfaction with healthcare, progression of kidney dysfunction, other biomarkers, missed school days, hospitalisations and mortality. The trial also includes an economic evaluation and process evaluation, which will assess the cost-effectiveness, fidelity and barriers and enablers of implementing a patient navigator program in this setting.Discussion: This study will provide clear evidence on the effectiveness and cost-effectiveness of a new intervention aiming to improve overall health and well-being for children with CKD from socioeconomically disadvantaged backgrounds, through a high quality, well-powered clinical trial.Trial Registration: Prospectively registered (12/07/2018) on the Australian New Zealand Clinical Trials Registry ( ACTRN12618001152213 ). [ABSTRACT FROM AUTHOR]

Background: Diminished mental health is associated with increased morbidity and mortality and may contribute to loss of independence and motivation in patients receiving dialysis and their caregivers. Increased understanding of the patient perspective on triggers, impacts and strategies for managing mental health may inform ways to address mental health conditions in this population., Methods: A secondary thematic analysis was undertaken using data from the Standardized Outcomes in Nephrology (SONG)-Hemodialysis and SONG-Peritoneal Dialysis projects. We extracted and analysed data on the perceived causes, meaning, impact and management of mental health in patients receiving dialysis from 26 focus groups (in six countries), multinational Delphi surveys and consensus workshops., Results: A total of 644 patients and caregivers participated. We identified five themes: bound to dialysis (forced into isolation, enslaved to a machine, stress of relentless planning and grieving the loss of a normal life), underrecognized and ignored (missed by health practitioners, need for mental health support), an uncertain future (dreading complications, coming to terms with mortality), developing self-reliance (vulnerability in being solely responsible for dialysis, sustaining motivation for dialysis, necessity for self-vigilance and taking charge to regulate emotions) and responding to a lifestyle overhaul (guilt of burdening family, controlling symptoms for overall mental wellness, protecting independence and trying to feel grateful)., Conclusions: Patients receiving dialysis and their caregivers endure mental and emotional distress attributed to the burden of dialysis, lifestyle restrictions, the constant threat of death and symptom burden, which can impair motivation for self-management. Increased attention to monitoring and management of mental health in this population is needed., (© The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.)