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Rationale & Objective: Growth failure is a common problem among children with chronic kidney disease (CKD). Reduced height is associated with psychosocial burden, social stigma, and impaired quality of life. This study aimed to describe the aspects of growth impairment that are most impactful from the perspectives of children with CKD, their parents, and health professionals., Study Design: Qualitative study., Settings & Participants: 120 children with CKD (aged 8-21 years), 250 parents, and 445 health professionals from 53 countries participated in 16 focus groups, two consensus workshops, and a Delphi survey., Analytical Approach: A thematic analysis of all qualitative data concerning growth from the Standardized Outcomes in Nephrology - Children and Adolescents (SONG-Kids) initiative., Results: We identified five themes: diminishing psychological wellbeing (compared to and judged by peers, tired of explaining to others, damaging self-esteem), constrained life participation and enjoyment (deprived of normal school experiences, excluded from sports or competing at a disadvantage, impaired quality of life in adulthood); grappling with impacts of symptoms and treatment (difficulty understanding short stature and accessing help, lack of appetite, uncertainty regarding bone pains, medication side effects, burden of growth hormone treatment); facilitating timely interventions and optimizing outcomes (early indicator of disease, assessing management, maximizing transplant outcomes, minimizing morbidity); and keeping growth and health priorities in perspective (quality of life and survival of utmost priority, achieved adequate height)., Limitations: Only English-speaking participants were included., Conclusions: Impaired growth may diminish psychological wellbeing, self-esteem, and participation in daily activities for children with CKD. Balancing different treatments that can affect growth complicates decision-making. These findings may inform the psychosocial support needed by children with CKD and their caregivers to address concerns about growth., (Copyright © 2024. Published by Elsevier Inc.)

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., (© The Author(s) 2024. Published by Oxford University Press on behalf of the ERA.)

Patient navigators enable adult patients to circumnavigate complex health systems, improving access to health care and outcomes. Here, we aimed to evaluate the effects of a patient navigation program in children with chronic kidney disease (CKD). In this multi-center, randomized controlled trial, we randomly assigned children (aged 0-16 years) with CKD stages 1-5 (including children on dialysis or with kidney transplants), from low socioeconomic status backgrounds, and/or residing in remote areas, to receive patient navigation at randomization (immediate) or at six months (waitlist). The primary outcome was self-rated health (SRH) of participating children at six months, using intention to treat analysis. Secondary outcomes included caregivers' SRH and satisfaction with health care, children's quality of life, hospitalizations, and missed school days. Repeated measures of the primary outcome from baseline to six months were analyzed using cumulative logit mixed effects models. Semi-structured interviews were thematically evaluated. Of 398 screened children, 162 were randomized (80 immediate and 82 waitlist); mean age (standard deviation) of 8.8 (4.8) years with 64.8% male. SRH was not significantly different between the immediate and wait-listed groups at six months. There were also no differences across all secondary outcomes between the two groups. Caregivers' perspectives were reflected in seven themes: easing mental strain, facilitating care coordination, strengthening capacity to provide care, reinforcing care collaborations, alleviating family tensions, inability to build rapport and unnecessary support. Thus, in children with CKD, self-rated health may not improve in response to a navigator program, but caregivers gained skills related to providing and accessing care., (Copyright © 2024 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

Objectives: The involvement of consumers (people with lived experience of disease) in guidelines is widely advocated to improve their relevance and uptake. However, the approaches to consumer involvement in guidelines vary and are not well documented. We describe the consumer involvement framework of Caring for Australians and New ZealandeRs with kidney Impairment Guidelines., Study Design and Setting: We used a descriptive document analysis to collate all relevant policies, documents, e-mails, and presentations on consumer involvement in our organizations. We performed a narrative synthesis of collated data to summarize our evolving consumer involvement approach in guidelines., Results: We involve consumers at all levels of Caring for Australians and New ZealandeRs with kidney Impairment guideline development and dissemination according to their capacity, from conducting consumer workshops to inform the scope of guidelines, to including consumers as members of the guideline Working Groups and overseeing operations and governance as members of the Steering Committee and staff. Our approach has resulted in tangible outcomes including high-priority topics on patient education, psychosocial care, and clinical care pathways, and focusing the literature reviews to assess patient-important outcomes. The ongoing partnership with consumers led to the generation of consumer version guidelines to improve guideline dissemination and translation to support shared decision-making., Conclusion: Meaningful consumer involvement can be achieved through a comprehensive approach across the entire lifecycle of guidelines. However, it must be individualized by ensuring that the involvement of consumers is timely and flexible. Future work is needed to assess the impact of consumer involvement in guideline development., Competing Interests: Declaration of competing interest None relevant., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Patient and caregiver involvement can enhance the uptake and impact of research, but the involvement of patients and caregivers who are underserved and marginalized is often limited. A better understanding of how to make involvement in research more broadly accessible, supportive, and inclusive for patients with chronic kidney disease (CKD) and caregivers is needed. We conducted a national workshop involving patients, caregivers, clinicians, and researchers from across Australia to identify strategies to increase the diversity of patients and caregivers involved in CKD research. Six themes were identified. Building trust and a sense of safety was considered pivotal to establishing meaningful relationships to support knowledge exchange. Establishing community and connectedness was expected to generate a sense of belonging to motivate involvement. Balancing stakeholder goals, expectations, and responsibilities involved demonstrating commitment and transparency by researchers. Providing adequate resources and support included strategies to minimize the burden of involvement for patients and caregivers. Making research accessible and relatable was about nurturing patient and caregiver interest by appealing to intrinsic motivators. Adapting to patient and caregiver needs and preferences required tailoring the approach for individuals and the target community. Strategies and actions to support these themes may support more diverse and equitable involvement of patients and caregivers in research in CKD., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Disadvantaged socioeconomic position (SEP) is an important predictor of poor health in children with chronic kidney disease (CKD). The time course over which SEP influences the health of children with CKD and their carers is unknown., Methods: This prospective longitudinal study included 377 children, aged 6-18 years with CKD (stages I-V, dialysis, and transplant), and their primary carers. Mixed effects ordinal regression was performed to assess the association between SEP and carer-rated child health and carer self-rated health over a 4-year follow-up., Results: Adjusted for CKD stage, higher family household income (adjusted odds ratio (OR) (95% CI) 3.3, 1.8-6.0), employed status of primary carers (1.7, 0.9-3.0), higher carer-perceived financial status (2.6, 1.4-4.8), and carer home ownership (2.2, 1.2-4.0) were associated with better carer-rated child health. Household income also had a differential effect on the carer's self-rated health over time (p = 0.005). The predicted probabilities for carers' overall health being 'very good' among lower income groups at 0, 2, and 4 years were 0.43 (0.28-0.60), 0.34 (0.20-0.51), and 0.25 (0.12-0.44), respectively, and 0.81 (0.69-0.88), 0.84 (0.74-0.91), and 0.88 (0.76-0.94) for carers within the higher income group., Conclusions: Carers and their children with CKD in higher SEP report better overall child and carer health compared with those in lower SEP. Carers of children with CKD in low-income households had poorer self-rated health compared with carers in higher-income households at baseline, and this worsened over time. These cumulative effects may contribute to health inequities between higher and lower SEP groups over time. Graphical abstract A higher resolution version of the Graphical abstract is available as Supplementary information., (© 2023. Crown.)

Background: School attendance and life participation, particularly sport, is a high priority for children with chronic kidney disease (CKD). This study is aimed at assessing the association between CKD stage, sports participation, and school absences in children with CKD., Methods: Using data from the binational Kids with CKD study (ages 6-18 years, n = 377), we performed multivariable regression to evaluate the association between CKD stage, school absences, and sports participation., Results: Overall, 62% of participants played sport with the most frequent sport activities engaged in being swimming (17%) and soccer (17%). Compared to children with CKD 1-2, the incidence rate ratios (IRR) (95% CI) for sports participation amongst children with CKD 3-5, dialysis, or transplant were 0.84 (0.64-1.09), 0.59 (0.39-0.90), and 0.75 (0.58-0.96), respectively. The median (IQR) days of school absences within a four-week period were 1 day (0-1), with children on dialysis reporting the highest number of school absences (9 days (5-15)), followed by transplant recipients (2 days (1-7)), children with CKD 3-5 (1 day (0-3)), and with CKD 1-2 (1 day (0-3)). Duration of CKD modified the association between CKD stage and school absences, with children with a transplant experiencing a higher number of missed school days with increasing duration of CKD, but not in children with CKD 1-5 or on dialysis (p-interaction < 0.01)., Conclusions: Children receiving dialysis and with a kidney transplant had greater school absences and played fewer sports compared to children with CKD stages 1-2. Innovative strategies to improve school attendance and sport participation are needed to improve life participation of children with CKD., (© 2023. Crown.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Children and adolescents in families of lower socioeconomic position (SEP) experience an inequitable burden of reduced access to healthcare and poorer health. For children living with chronic kidney disease (CKD), disadvantaged SEP may exacerbate their considerable disease burden. Across the life-course, CKD may also compromise the SEP of families and young people, leading to accumulating health and socioeconomic disadvantage. This narrative review summarizes the current evidence on relationships of SEP with kidney care and health among children and adolescents with CKD from a life-course approach, including impacts of family SEP on kidney care and health, and bidirectional impacts of CKD on SEP. It highlights relevant conceptual models from social epidemiology, current evidence, clinical and policy implications, and provides directions for future research. Reflecting the balance of available evidence, we focus primarily on high-income countries (HICs), with an overview of key issues in low- and middle-income countries (LMICs). Overall, a growing body of evidence indicates sobering socioeconomic inequities in health and kidney care among children and adolescents with CKD, and adverse socioeconomic impacts of CKD. Dedicated efforts to tackle inequities are critical to ensuring that all young people with CKD have the opportunity to live long and flourishing lives. To prevent accumulating disadvantage, the global nephrology community must advocate for local government action on upstream social determinants of health; and adopt a life-course approach to kidney care that proactively identifies and addresses unmet social needs, targets intervening factors between SEP and health, and minimizes adverse socioeconomic outcomes across financial, educational and vocational domains., (© 2024 International Society of Nephrology. Published by Elsevier Inc.)

Cancer has been identified by kidney transplant recipients as a critically important outcome. The co-occurrence of cancer and kidney transplantation represents a complex intersection of diseases, symptoms, and competing priorities for treatments. Research that focuses on biochemical parameters and clinical events may not capture the priorities of patients. Patient-centered research can improve the relevance and efficiency of research and is particularly pertinent in the setting of cancer and kidney transplantation to facilitate shared decision-making in complex clinical situations. In addition, patient-reported outcomes can facilitate the assessment of patients' experiences, symptom burden, treatment side effects, and quality of life. This review discusses patient-centered research in the context of kidney transplantation and cancer, including consumer involvement in research and patient-centered outcomes and their measures and inclusion in core outcome sets., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Patient involvement in research can improve the relevance of research, consequently enhancing the recruitment, retention, and uptake of interventions and policies impacting patient outcomes. Despite this, patients are not often involved in the design and conduct of research. The research agenda and innovations are frequently determined by the interest of health and industry professionals rather than proactively aligning with the priorities of patients. It is now being encouraged and recommended to engage patients in research priority setting to ensure interventions and trials report outcomes valuable to patients, moving away from a history of overlooking the outcomes that reflect the feel and function of patients. Involving patients ensures constant innovative research in nephrology, as this broader depth of evidence fortifies reliability and validity through knowledge gained from lived experience. Findings from such research can enhance clinical practice and strengthen decision-making and policy to support better outcomes. We aim to outline principles and strategies for patient involvement in research, including setting research priorities, identifying and designing interventions, selecting outcomes, and disseminating and translating research. Principles and strategies including engagement, education and training, empowerment, and connection and community provide guidance in patient involvement. There are increasing efforts to involve patients across all stages of research including setting research priorities. Efforts are rising to involve patients across all stages of research including priority setting, identifying and designing interventions, selecting outcomes, and dissemination and translation. Patient involvement throughout the research cycle drives innovative investigations ensuring funding, efforts, and resources are directed toward priorities of patients, contributing to catalyst advancements in care and outcomes., (Copyright © 2023 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Clotting of the extracorporeal circuit is a complication in the process of hemodialysis that can result in missed or shortened dialysis sessions, higher nursing workload, and elevated cost of treatment. Repercussions of inadequate dialysis may include patient blood loss, fluid overload, build-up of minerals, higher hospitalization rates, and poor quality of life, contributing to increased patient distress. Preventing clotting through anticoagulation therapy is the key to maintaining patency of the dialysis circuit and supporting dialysis adequacy. Despite the severe consequences of clotting in the extracorporeal circuit patients encounter, their perspectives on decision-making regarding anticoagulation therapy are not well known. In this article, we discuss patients' perspectives and priorities around clotting and anticoagulation therapy and outline ways to support their treatment through shared decision-making. Insights into patients' perspectives on addressing thrombotic complications of the extracorporeal circuit can inform strategies to improve care and outcomes for patients receiving hemodialysis., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Rationale & Objective: COVID-19 disproportionately affects people with comorbidities, including chronic kidney disease (CKD). We describe the impact of COVID-19 on people with CKD and their caregivers., Study Design: A systematic review of qualitative studies., Setting & Study Populations: Primary studies that reported the experiences and perspectives of adults with CKD and/or caregivers were eligible., Search Strategy & Sources: MEDLINE, Embase, PsycINFO, CINAHL searched from database inception to October 2022., Data Extraction: Two authors independently screened the search results. Full texts of potentially relevant studies were assessed for eligibility. Any discrepancies were resolved by discussion with another author., Analytical Approach: A thematic synthesis was used to analyze the data., Results: Thirty-four studies involving 1,962 participants were included. Four themes were identified: exacerbating vulnerability and distress (looming threat of COVID-19 infection, intensifying isolation, aggravating pressure on families); uncertainty in accessing health care (overwhelmed by disruption of care, confused by lack of reliable information, challenged by adapting to telehealth, skeptical about vaccine efficacy and safety); coping with self-management (waning fitness due to decreasing physical activity, diminishing ability to manage diet, difficulty managing fluid restrictions, minimized burden with telehealth, motivating confidence and autonomy); and strengthening sense of safety and support (protection from lockdown restrictions, increasing trust in care, strengthened family connection)., Limitations: Non-English studies were excluded, and inability to delineate themes based on stage of kidney and treatment modality., Conclusions: Uncertainty in accessing health care during the COVID-19 pandemic exacerbated vulnerability, emotional distress, and burden, and led to reduced capacity to self-manage among patients with CKD and their caregivers. Optimizing telehealth and access to educational and psychosocial support may improve self-management and the quality and effectiveness of care during a pandemic, mitigating potentially catastrophic consequences for people with CKD., Plain-Language Summary: During the COVID-19 pandemic, patients with chronic kidney disease (CKD) faced barriers and challenges to accessing care and were at an increased risk of worsened health outcomes. To understand the perspectives about the impact of COVID-19 among patients with CKD and their caregivers, we conducted a systematic review of 34 studies involving 1,962 participants. Our findings demonstrated that uncertainty in accessing care during the COVID-19 pandemic exacerbated the vulnerability, distress, and burden of patients and impaired their abilities for self-management. Optimizing the use of telehealth and providing education and psychosocial services may mitigate the potential consequences for people with CKD during a pandemic., (Copyright © 2023 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: The authors have no conflicts of interest to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the ERA.)

Background: Females account for 60% of all living kidney donors worldwide. We defined the proportion of female to male donors for living donor kidney transplantation stratified by recipient gender, and explored the factors associated with female kidney donation., Methods: Data from the ANZDATA (Australian and New Zealand Dialysis and Transplantation) and ANZOD (Australian and New Zealand Organ Donor) registries (2002-2019) were used to identify the sociodemographic characteristics and their interactions associated with living donation from female donors. We derived the predicted probabilities from adjusted logistic models using marginal means., Results: Of 3523 living donor pairs, 2203 (63%) recipients were male, and 2012 (57%) donors were female. Male recipients were more likely to receive kidneys from female donors than male donors. Donor and recipient sex association was modified by donor-recipient relationship ( P  < 0.01), with sensitivity analysis suggesting that spousal donor-recipient pairs drive this interaction. Older recipients residing in regional or remote areas were more likely to receive kidneys from female donors compared with those from major cities (aged ≥60 years: 0.67 [0.63-0.71] vs. aged <60 years: 0.57 [0.53-0.60])., Conclusions: Factors associated with female donation include recipient sex, with spousal donors contributing to the interaction between recipient gender and donor-recipient relationship. Recipient age and location of residence have interactive effects on the likelihood of living donor transplantation from female donors., (© 2023 International Society of Nephrology. Published by Elsevier Inc.)

Background: Children with chronic kidney disease (CKD) require multidisciplinary care to meet their complex healthcare needs. Patient navigators are trained non-medical personnel who assist patients and caregivers to overcome barriers to accessing health services through care coordination. This trial aims to determine the effectiveness of a patient navigator program in children with CKD., Methods: The NAVKIDS 2 trial is a multi-center, waitlisted, randomized controlled trial of patient navigators in children with CKD conducted at five sites across Australia. Children (0-16 years) with CKD from low socioeconomic status rural or remote areas were randomized to an intervention group or a waitlisted control group (to receive intervention after 6 months). The study primary and secondary endpoints include the self-rated health (SRH) (primary), and utility-based quality of life, progression of kidney dysfunction of the child, SRH, and satisfaction with healthcare of the caregiver at 6 months post-randomization., Results: The trial completed recruitment in October 2021 with expected completion of follow-up by October 2022. There were 162 patients enrolled with 80 and 82 patients randomized to the immediate intervention and waitlisted groups, respectively. Fifty-eight (36%) participants were from regional/remote areas, with a median (IQR) age of 9.5 (5.0, 13.0) years, 46% were of European Australian ethnicity, and 65% were male. A total of 109 children (67%) had CKD stages 1-5, 42 (26%) were transplant recipients, and 11 (7%) were receiving dialysis., Conclusion: The NAVKIDS 2 trial is designed to evaluate the effectiveness of patient navigation in children with CKD from families experiencing socioeconomic disadvantage. A higher resolution version of the Graphical abstract is available as Supplementary information., (© 2022. The Author(s), under exclusive licence to International Pediatric Nephrology Association.)

In this multi-center longitudinal cohort study conducted in Australia and New Zealand, we assessed the trajectories of health-related quality of life (HRQoL) in children with chronic kidney disease (CKD) over time. A total of 377 children (aged 6-18 years) with CKD stages 1-5 (pre-dialysis), dialysis, or transplant, were followed biennially for four years. Multi Attribute Utility (MAU) scores of HRQoL were measured at baseline and at two and four years using the McMaster Health Utilities Index Mark 3 tool, a generic multi-attribute, preference-based system. A multivariable linear mixed model was used to assess the trajectories of HRQoL over time in 199 children with CKD stage 1-5, 43 children receiving dialysis and 135 kidney transplant recipients. An interaction between CKD stage at baseline and follow-up time indicated that the slopes of the HRQoL scores differed between children by CKD stage at inception. Over half of the cohort on dialysis at baseline had received a kidney transplant by the end of year four and the MAU scores of these children increased by a meaningful amount averaging 0.05 (95% confidence interval 0.01 to 0.09) per year in comparison to those who were transplant recipients at baseline. The mean difference between baseline and year two MAU scores was 0.09 (95% confidence interval -0.05, 0.23), (Cohen's d effect size 0.31). Thus, improvement in HRQoL over time of children on dialysis at baseline was likely to have been driven by their transition from dialysis to transplantation. Additionally, children with CKD stage 1-5 and transplant recipients at baseline had no changes in their disease stage or treatment modality and experienced stable HRQoL over time., (Copyright © 2022 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

Introduction: eHealth supports the delivery of relevant health information and management of chronic disease. However, little is known about patients' perspectives and the determinants of eHealth use among kidney transplant recipients., Methods: Kidney transplant recipients aged 18 years and older from 3 transplant units in Australia and the Better Evidence and Translation in Chronic Kidney Disease consumer network completed a survey with free-text responses relating to eHealth uptake. Multivariable regression modeling was used to determine the factors associated with eHealth use. Free-text responses were thematically analyzed., Results: Of the 117 participants who were invited in person and who responded to the email, 91 completed the survey. Sixty-three participants (69%) were current eHealth users (active use of eHealth tools), and 91% had access to eHealth devices, including smartphones (81%) and computers (59%). Most (98%) reported that eHealth improves posttransplant care. Factors associated with increased eHealth use (odds ratio [95% confidence interval]) were higher eHealth literacy scale (eHEALS) score (1.21 [1.06-1.38]) and tertiary education (7.78 [2.19-27.7]). We identified the following 3 themes on eHealth determinants: (i) empowering self-management, (ii) enhancing health services, and (iii) technology burden., Conclusions: Transplant recipients believe that eHealth interventions have the potential to improve their posttransplant care. eHealth interventions should meet the needs of all transplant recipients and be accessible to those with lower educational attainment., (© 2023 Published by Elsevier, Inc.)

Background: This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS 2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published., Methods/design: The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018., (© 2022. The Author(s).)

Randomised controlled clinical trials provide the gold standard for evidence underpinning clinical guidelines and patient centred care. However, this is only true when they are robustly designed, conducted and reported and then only if they include outcomes that are important to patients and clinicians. Important outcomes include those that measure impact on patient experience, quality of life, overall well-being, and physical, social, cognitive and emotional functioning, all of which require patient reported outcome measures (PROMs). Patient centred care must be underpinned by objective evidence of the effect of interventions on outcomes that are important to patients. Evidence for patient reported outcomes must be supported by valid and reliable PROMs. Importantly the PROM must reflect patient experience of the impact of the intervention on the outcome and enable quantitative evaluation of that impact. The purpose of this paper is to highlight the critical role of mixed methods research in developing PROMs that are valid (measure what they purport to measure), acceptable to those reporting the outcome and able to reliably detect meaningful differences between individuals with different conditions or severity and with time. This can only be achieved through a structured mixed methods program combining qualitative and quantitative research techniques., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Rationale & Objective: Clinical decision-making priorities may differ among children, their parents, and their clinicians. This study describes clinicians' perspectives on shared decision making in pediatric chronic kidney disease (CKD) and identifies opportunities to improve shared decision making and care for children with CKD and their families., Study Design: Semistructured interviews., Setting & Participants: Fifty clinicians participated, including pediatric nephrologists, nurses, social workers, surgeons, dietitians, and psychologists involved in providing care to children with CKD. They worked at 18 hospitals and 4 university research departments across 11 countries (United States of America, Canada, Australia, People's Republic of China, United Kingdom, Germany, France, Italy, Lithuania, New Zealand, and Singapore)., Analytical Approach: Interview transcripts were analyzed thematically., Results: We identified 4 themes: (1) striving to blend priorities (minimizing treatment burden, emphasizing clinical long-term risks, achieving common goals), (2) focusing on medical responsibilities (carrying decisional burden and pressure of expectations, working within system constraints, ensuring safety is foremost concern), (3) collaborating to achieve better long-term outcomes (individualizing care, creating partnerships, encouraging ownership and participation in shared decision making, sensitive to parental distress), and (4) forming cumulative knowledge (balancing reassurance and realistic expectations, building understanding around treatment, harnessing motivation for long-term goals)., Limitations: Most clinicians were from high-income countries, so the transferability of the findings to other settings is uncertain., Conclusions: Clinicians reported striving to minimize treatment burden and working with children and their families to manage their expectations and support their decision making. However, they are challenged with system constraints and sometimes felt the pressure of being responsible for the child's long-term outcomes. Further studies are needed to test whether support for shared decision making would promote strategies to establish and improve the quality of care for children with CKD., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (© The Author(s) 2021. Published by Oxford University Press on behalf of ERA-EDTA.)

Background: Patients receiving dialysis have low employment rates, which compounds poorer health and socioeconomic outcomes. Reasons for under- and unemployment remain underexplored. We aimed to describe the perspectives of patients receiving hemodialysis (HD) or peritoneal dialysis (PD) and their caregivers on ability to work., Methods: Data was derived from adult patients' and caregivers' responses from 26 focus groups, two international Delphi surveys and two consensus workshops conducted through the Standardized Outcomes in Nephrology (SONG-HD) and SONG-PD programs. Our secondary thematic analysis identified concepts around ability to work., Results: Five hundred four patients and 146 caregivers from 86 countries were included. We identified five themes: financial pressures and instability (with subthemes of rationing the budget with increased expenditure, losing financial independence and threatened job security); struggling to meet expectations (burdened by sociocultural norms and striving to protect independence); contending with upheaval of roles and responsibilities (forced to establish a new routine to accommodate work, symptoms disrupting work, prioritizing work and other duties, and adjusting to altered capacity to work); enabling flexibility and control (employment driving decisions about dialysis modality and schedule, workplace providing occupational safety and adaptability, requiring organizational support and planning for a future career); and finding purpose and value (accepting and redefining identity, pride and fulfillment, and protecting mental well-being)., Conclusions: Employment enabled patients to maintain their identity, independence, financial security and mental health. Symptom burden, workplace inflexibility and juggling roles are major challenges. Interventions addressing motivation, workplace flexibility and safety, and establishing goals and routines could support patients' capacities to work, thereby improving overall well-being and productivity., (© 2021. Italian Society of Nephrology.)

Importance: Transgender and nonbinary youths have a higher incidence of a range of health conditions and may paradoxically face limited access to health care., Objective: To describe the perspectives and needs of transgender youths in accessing health care., Evidence Review: MEDLINE, Embase, PsycInfo, and the Cumulative Index to Nursing and Allied Health Literature were searched from inception to January 2021. Qualitative studies of transgender youths' perspectives on accessing health care were selected. Results from primary studies were extracted. Data were analyzed using thematic synthesis., Findings: Ninety-one studies involving 884 participants aged 9 to 24 years across 17 countries were included. We identified 6 themes: experiencing pervasive stigma and discrimination in health care, feeling vulnerable and uncertain in decision-making, traversing risks to overcome systemic barriers to transitioning, internalizing intense fear of consequences, experiencing prejudice undermining help-seeking efforts, and experiencing strengthened gender identity and finding allies. Each theme encapsulated multiple subthemes., Conclusions and Relevance: This review found that transgender youths contend with feelings of gender incongruence, fear, and vulnerability in accessing health care, which are compounded by legal, economic, and social barriers. This can lead to disengagement from care and resorting to high-risk and unsafe interventions. Improving access to gender-affirming care services with a cultural humility lens and addressing sociolegal stressors may improve outcomes in transgender and nonbinary youths.

Chronic kidney disease is associated with an increased risk of mortality, comorbidities and life-threatening complications. Invasive treatments including dialysis or transplantation, complex pharmacological therapies, dietary restrictions and the ongoing need to attend follow-up appointments can place a substantial treatment burden on patients and carers and impair quality of life. This highlights the need for care that is responsive to the needs of patients and involves them in decision-making to achieve the most appropriate healthcare outcomes. Shared decision-making and collaborative approaches to care require a deep awareness of the lived experiences and goals of patients. Qualitative research methods can provide insights into patients' experiences, values and priorities and inform practice and policy by uncovering their preferences for care. Qualitative methods are increasingly being used in standalone projects or in mixed methods studies (complementing quantitative studies) to make valuable contributions to patient-centred research. Patient-centred care, collaborations between patient and care provider, and shared decision-making that integrates with the patient's goals are central to quality healthcare. The efficacy of qualitative research lies in its ability to elicit patients' perspectives, values, priorities and goals that underpin shared decision making and care. This article discusses examples of how qualitative research has informed practice and policy in nephrology, provides a summary of qualitative research methods and outlines a guide on how to appraise, interpret and apply qualitative data., (© 2021 Asian Pacific Society of Nephrology.)

Medicine-taking among transplant recipients is a complex and ubiquitous task with significant impacts on outcomes. This study aimed to describe the perspectives and experiences of medicine-taking in adult solid organ transplant recipients. Electronic databases were searched to July 2020, and thematic synthesis was used to analyze the data. From 119 studies (n = 2901), we identified six themes: threats to identity and ambitions (impaired self-image, restricting goals and roles, loss of financial independence); navigating through uncertainty and distrust (lacking tangible/perceptible benefits, unprepared for side effects, isolation in decision-making); alleviating treatment burdens (establishing and mastering routines, counteracting side effects, preparing for the unexpected); gaining and seeking confidence (clarity with knowledge, reassurance through collective experiences, focusing on the future outlook); recalibrating to a new normal posttransplant (adjusting to ongoing dependence on medications, in both states of illness and health, unfulfilled expectations); and preserving graft survival (maintaining the ability to participate in life, avoiding rejection, enacting a social responsibility of giving back). Transplant recipients take medications to preserve graft function, but dependence on medications jeopardizes their sense of normality. Interventions supporting the adaptation to medicine-taking and addressing treatment burdens may improve patient satisfaction and capacities to take medications for improved outcomes., (© 2021 The American Society of Transplantation and the American Society of Transplant Surgeons.)

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 ., (© 2021. The Author(s).)

Sleep disturbances are common among patients receiving dialysis and are associated with an increased risk of mortality and morbidity, and impaired quality of life. Despite being highly prioritised by patients, sleep problems remain under-diagnosed and inadequately managed. The aim of the present study was to describe the perspectives of patients receiving dialysis and their caregivers on sleep. We extracted qualitative data on sleep from 26 focus groups, two international Delphi surveys, and two consensus workshops involving 644 patients and caregivers from 86 countries as part of the Standardised Outcomes in Nephrology-Haemodialysis and -Peritoneal Dialysis (SONG-HD/SONG-PD) initiatives. The responses were from patients aged ≥18 years receiving haemodialysis or peritoneal dialysis, and their caregivers. We analysed the data using thematic analysis with five themes identified: constraining daily living (with subthemes of: battling intrusive tiredness, exacerbating debilitating conditions, broken and incapacitated); roadblocks in relationships (unable to meet family needs, antipathy due to misunderstanding, wreaking emotional havoc); burden on caregivers (stress on support persons, remaining alert to help); losing enjoyment (limiting social contact, disempowerment in life); and undermining mental resilience (aggravating low mood, diminishing coping skills, reducing functional ability). Sleep disturbances are exhausting for patients on dialysis and pervade all aspects of their lives including the ability to do daily tasks, and maintaining relationships, mental and emotional well-being. Better assessment and management of sleep problems in dialysis is needed, which may lead to improvements in overall health and quality of life., (© 2020 European Sleep Research Society.)

Objective: To describe how the Australian Government Department of Health policies address equity in the management of chronic kidney disease (CKD)., Methods: We searched the websites of the Australian Government Department of Health, Kidney Health Australia, Australian Indigenous HealthInfoNet and the National Rural Health Alliance for policies using the search terms: kidney, renal and chronic., Results: We included 24 policies that addressed groups of people that experience health inequities: 23 addressed Aboriginal and Torres Strait Islander peoples, 18 rural/remote communities, 12 low socioeconomic status groups, six culturally and linguistically diverse communities and four addressed gender disparities. The scope of the policies ranged from broad national frameworks to subsidised access to health services and medicines. Only two policies explicitly addressed equity for patients with CKD., Conclusion: CKD outcomes are highly variable across population groups yet Australian Government policies that address access to and the experience of care are limited in both number and their attention to equity issues. Implications for public health: In Australia, some groups of people with CKD have a substantially higher risk of mortality and morbidity than the general CKD population. We advocate for the development and implementation of policies to attain equity for people with CKD., (© 2021 The Authors.)

The COVID-19 pandemic has challenged the delivery of health services. Telehealth allows delivery of care without in-person contacts and minimizes the risk of vial transmission. We aimed to describe the perspectives of kidney transplant recipients on the benefits, challenges, and risks of telehealth. We conducted five online focus groups with 34 kidney transplant recipients who had experienced a telehealth appointment. Transcripts were thematically analyzed. We identified five themes: minimizing burden (convenient and easy, efficiency of appointments, reducing exposure to risk, limiting work disruptions, and alleviating financial burden); attuning to individual context (depending on stability of health, respect patient choice of care, and ensuring a conducive environment); protecting personal connection and trust (requires established rapport with clinicians, hampering honest conversations, diminished attentiveness without incidental interactions, reassurance of follow-up, and missed opportunity to share lived experience); empowerment and readiness (increased responsibility for self-management, confidence in physical assessment, mental preparedness, and forced independence); navigating technical challenges (interrupted communication, new and daunting technologies, and cognizant of patient digital literacy). Telehealth is convenient and minimizes time, financial, and overall treatment burden. Telehealth should ideally be available after the pandemic, be provided by a trusted nephrologist and supported with resources to help patients prepare for appointments., (© 2021 The Authors. Transplant International published by John Wiley & Sons Ltd on behalf of Steunstichting ESOT.)

Background: Pain is the highest prioritized patient-reported outcome in people with autosomal dominant polycystic kidney disease (ADPKD) but remains infrequently and inconsistently measured in clinical trials and poorly managed in clinical settings. A recently completed systematic review of pain in ADPKD identified 26 different outcome measures. None of these measures were considered appropriate as a core outcome measure due to the lack of patient-important dimensions, inadequate content, relatively long duration of completion time and limited evidence to support psychometric robustness., Methods: We convened an international Standardized Outcomes in Nephrology-Polycystic Kidney Disease consensus workshop involving 21 patients/caregivers and 40 health professionals (clinicians, nurses, researchers, policy makers and industry representatives) from 18 countries to discuss the identification or development of a core outcome measure for pain., Results: Four themes were identified highlighting fundamental issues for the measurement of pain in ADPKD: distressing and disrupting life participation; variability and ambiguity in defining pain; stigma, frustration and adaptation to pain; and ensuring validity and feasibility of pain measures., Conclusions: Existing measures were found to be insufficient in capturing pain as a core outcome and there was consensus on the need for a new validated measure that is simple, succinct and addresses the impact of pain on life participation. This measure will facilitate the appropriate prioritization of pain in all trials and guide clinical decision making in people with ADPKD., (© The Author(s) 2021. Published by Oxford University Press on behalf of the ERA.)

Objective: To describe patient perspectives on recruitment and retention in clinical trials., Study Design and Setting: Systematic review of qualitative studies that reported the perspective of adult patients with any health condition who accepted or declined to participate in clinical trials., Results: Sixty-three articles involving 1681 adult patients were included. Six themes were identified. Four themes reflected barriers: ambiguity of context and benefit - patients were unaware of the research question and felt pressured in making decisions; lacking awareness of opportunities - some believed health professionals obscured trials opportunities, or felt confused because of language barriers; wary of added burden - patients were without capacity because of sickness or competing priorities; and skepticism, fear and mistrust - patients feared loss of privacy, were suspicious of doctor's motivation, afraid of being a guinea pig, and disengaged from not knowing outcomes. Two themes captured facilitators: building confidence - patients hoped for better treatment, were supported from family members and trusted medical staff; and social gains and belonging to the community - altruism, a sense of belonging and peer encouragement motivated participation in trials., Conclusion: Improving the visibility and transparency of trials, supporting informed decision making, minimizing burden, and ensuring confidence and trust may improve patient participation in trials., (Copyright © 2021. Published by Elsevier Inc.)

Rationale and Objective: Sleep problems affect more than half of patients receiving dialysis and are associated with increased risk of mortality, cardiovascular events, depression and impaired functioning and quality of life. Symptoms such as fatigue and exhaustion may be attributed to sleep problems or sleep disorders, as well as the burden of kidney disease and treatment. This study aims to describe the patient perspectives on the reasons, impact and management of sleep problems in dialysis., Study Design: Systematic review and thematic synthesis of qualitative studies that report patient experience and perspectives on sleep in dialysis., Setting and Population: Patients receiving dialysis., Search Strategy and Sources: MEDLINE, Embase, PsycINFO, CINAHL, reference lists and PhD dissertations were searched from inception to August 2019., Data Extraction: All text from the results/conclusion of the primary studies., Analytical Approach: Thematic synthesis., Results: We included 48 studies involving 1156 participants from 16 countries. We identified six themes: dominating demands of treatment (with subthemes of: demanding and relentless schedule, regret for wasted time); scheduling and control (managing sleep routines, napping and nocturnal sleep disruption, meditative aids); disruptions due to dialysis (unsettled sleep, hypervigilance and worry); symptoms depriving sleep (difficulty falling asleep, constant waking); overwhelmed and without choice (futility of sleep, uncontrollable exhaustion, restlessness is irrepressible); and as a coping mechanism (avoiding anxiety, alleviating symptoms, combating boredom)., Limitations: Most studies were conducted in high-income, English-speaking countries., Conclusion: The treatment and symptom burden of dialysis disrupts and deprives patients of sleep, which leads to overwhelming and uncontrollable exhaustion. Better management of symptoms and effective strategies to manage sleep routines may improve sleep quality for better overall health in patients receiving dialysis., (Crown Copyright © 2021. Published by Elsevier B.V. All rights reserved.)

While patient-centered care is widely advocated in the management of rheumatic diseases, it can be challenging to implement, particularly for patients with complex systemic conditions. Patient-centered care involves identifying and integrating the patient's experiences, attitudes, and preferences in decision-making. Qualitative research is used to describe patient perspectives and priorities that may not always be expressed in clinical settings. Systematic reviews of qualitative studies can provide new and more comprehensive evidence of patients' beliefs and priorities across different populations and healthcare settings and are increasingly being reported across medical specialties, including rheumatology. In rheumatology, they have been used to examine topics including medication-taking and adherence, coping with systemic sclerosis and conservative management and exercise in osteoarthritis. By referencing recent examples of systematic qualitative reviews in the rheumatology literature, this article will outline the methodology and methods used, and provide an approach to guide the appraisal of reviews. We aim to give the reader a practical understanding of systematic reviews of qualitative literature and elucidate how knowledge gained from such reviews can be applied to improve the care of patients with rheumatic conditions., (© 2020 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.)

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.)

Background and Objective: Patients with early chronic kidney disease (CKD) face challenges in accessing healthcare, including delays in diagnosis, fragmented speciality care and lack of tailored education and psychosocial support. Patient navigator programmes have the potential to improve the process of care and outcomes. The objective of this study is to describe the experiences of patients on communication, access of care and self-management and their perspectives on patient navigator programmes in early CKD., Design, Setting and Participants: We convened a workshop in Australia with 19 patients with CKD (all stages including CKD Stage 1 to 5 not on dialysis, 5D (dialysis), and 5T (transplant)) and five caregivers. All of them were over 18 years and English-speaking. Transcripts from the workshop were analysed thematically., Results: Four themes that captured discussions were: lost in the ambiguity of symptoms and management, battling roadblocks while accessing care, emotionally isolated after diagnosis and re-establishing lifestyle and forward planning. Five themes that focussed on patient navigator programmes were: trust and credibility, respecting patient choices and readiness to accept the programme, using accessible language to promote the programme, offering multiple ways to engage and communicate and maintaining confidentiality and privacy. Of the 17 features identified as important for a patient navigator programme, the top five were delivery of education, psychosocial support, lifestyle modification, communication and decision-making support and facilitating care., Conclusion: Patient navigator services can address gaps in services around health literacy, communication, psychosocial support and coordination across multiple healthcare settings. In comparison to the existing navigator programmes, and other services that are aimed at addressing these gaps, credible, accessible and flexible patient navigator programmes for patients with early CKD, that support education, decision-making, access to care and self-management designed in partnership with patients, may be more acceptable to patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Many countries have suspended kidney transplantation programmes during the COVID-19 pandemic because of concerns for patient safety and the shortage of healthcare resources. This study aimed to describe patient, family member and potential donor perspectives on the suspension and resumption of kidney transplant programmes due to COVID-19. We conducted seven online focus groups involving 31 adult kidney transplant candidates (n = 22), caregivers (n = 4) and potential donors (n = 5). Transcripts were analysed thematically. We identified five themes: cascading disappointments and devastation (with subthemes of shattering hope, succumbing to defeat, regret and guilt); helplessness and vulnerability (fear of declining health, confronted by the threat of and change in dialysis, disconnected from health care, susceptibility to infective complications); stress from uncertainty (confusion from conflicting information, unable to forward plan), exacerbating burdens (incurring extra financial costs, intensifying caregiver responsibilities), and sustaining health through the delay (protecting eligibility, relying on social support, adapting to emerging modalities of care). During the suspension of kidney transplantation programmes, patients felt medically vulnerable because of declining health, susceptibility to infection and reduced access to care. There is a need to address health vulnerabilities, disappointment, uncertainty and additional burdens arising from the suspension of kidney transplantation programmes., (© 2020 Steunstichting ESOT. Published by John Wiley & Sons Ltd.)

Objectives: There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials., Design: In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically., Setting: International., Subjects: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public, and health professionals (including clinicians, policy makers, regulators, funders, and researchers)., Interventions: None., Measurements: None., Main Results: In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median ≥ 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes., Conclusions: Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals.

Objective: To describe the perspectives on life participation by young adults with childhood-onset chronic kidney disease (CKD)., Design: Semi-structured interviews; thematic analysis., Setting: Multiple centres across six countries (Australia, Canada, India, UK, USA and New Zealand)., Participants: Thirty young adults aged 18 to 35 years diagnosed with CKD during childhood., Results: We identified six themes: struggling with daily restrictions (debilitating symptoms and side effects, giving up valued activities, impossible to attend school and work, trapped in a medicalised life, overprotected by adults and cautious to avoid health risks); lagging and falling behind (delayed independence, failing to keep up with peers and socially inept); defeated and hopeless (incapacitated by worry, an uncertain and bleak future, unworthy of relationships and low self-esteem and shame); reorienting plans and goals (focussing on the day-to-day, planning parenthood and forward and flexible planning); immersing oneself in normal activities (refusing to miss out, finding enjoyment, determined to do what peers do and being present at social events); and striving to reach potential and seizing opportunities (encouragement from others, motivated by the illness, establishing new career goals and grateful for opportunities)., Conclusions: Young adults encounter lifestyle limitations and missed school and social opportunities as a consequence of developing CKD during childhood and as a consequence lack confidence and social skills, are uncertain of the future, and feel vulnerable. Some re-adjust their goals and become more determined to participate in 'normal' activities to avoid missing out. Strategies are needed to improve life participation in young adult 'graduates' of childhood CKD and thereby strengthen their mental and social well-being and enhance their overall health., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Rationale & Objective: The inconsistency in outcomes reported and lack of patient-reported outcomes across trials in children with chronic kidney disease (CKD) limits shared decision making. As part of the Standardized Outcomes in Nephrology (SONG)-Kids initiative, we aimed to generate a consensus-based prioritized list of critically important outcomes to be reported in all trials in children with CKD., Study Design: An online 2-round Delphi survey in English, French, and Hindi languages., Settings & Participants: Patients (aged 8-21 years), caregivers/family, and health care professionals (HCPs) rated the importance of outcomes using a 9-point Likert scale (7-9 indicating critical importance) and completed a Best-Worst Scale., Analytical Approach: We assessed the absolute and relative importance of outcomes. Comments were analyzed thematically., Results: 557 participants (72 [13%] patients, 132 [24%] caregivers, and 353 [63%] HCPs) from 48 countries completed round 1 and 312 (56%) participants (28 [40%] patients, 64 [46%] caregivers, and 220 [56%] HCPs) completed round 2. Five outcomes were common in the top 10 for each group: mortality, kidney function, life participation, blood pressure, and infection. Caregivers and HCPs rated cardiovascular disease higher than patients. Patients gave lower ratings to all outcomes compared with caregivers/HCPs except they rated life participation (round 2 mean difference, 0.1), academic performance (0.1), mobility (0.4), and ability to travel (0.4) higher than caregivers and rated ability to travel (0.4) higher than HCPs. We identified 3 themes: alleviating disease and treatment burden, focusing on the whole child, and resolving fluctuating and conflicting goals., Limitations: Most participants completed the survey in English., Conclusions: Mortality, life participation, kidney function, and blood pressure were consistently highly prioritized by patients, caregivers, and HCPs. Patients gave higher priority to some lifestyle-related outcomes compared with caregivers/HCPs. Establishing critically important outcomes for all trials in children with CKD may improve consistent reporting of survival, kidney health, and clinical and life impact outcomes that are meaningful for decision making., (Copyright © 2020 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Abstract: Pain is a severe and common symptom in patients receiving dialysis but remains inadequately managed in clinical practice. Understanding patient experiences of pain can inform strategies to address this patient-important symptom. We aimed to describe patients' perspectives on causes, experiences, and impacts of dialysis-associated pain. MEDLINE, Embase, PsycINFO, and CINAHL were searched to August 2019 for all qualitative studies that described the perspectives of pain in adults aged 18 years or older receiving dialysis. Findings from the primary studies were analyzed using thematic synthesis. We included 60 studies across 14 countries involving 1343 participants (1215 receiving hemodialysis and 128 receiving peritoneal dialysis), and identified 6 themes: gripped by an all-consuming agony (draining cognitive capacity, exacerbating other symptoms); suffering in silence (surrendering to the inevitable, ignored or dismissed, hiding symptoms to protect others); provoking fear of treatment (resistance to cannulation, avoiding dialysis, anxious from witnessing other patients in pain); preventing life participation (preventing fulfilment of valued roles, depleting the will to live); coping aided by connection with others (shared understanding among patients, comforted and supported by others); and developing awareness, assertiveness, and self-reliance (procedural vigilance, finding strategies to minimize pain, bodily understanding and knowing thresholds, positive thinking). Struggling with pain in dialysis involved a progression of agony, fear, avoidance, and despair. However, support from others and self-management strategies were used to cope with pain. Strategies to empower patients to report and minimize pain and its consequences in dialysis are needed., (Copyright © 2020 International Association for the Study of Pain.)

Trials in children with chronic kidney disease do not consistently report outcomes that are critically important to patients and caregivers. This can diminish the relevance and reliability of evidence for decision making, limiting the implementation of results into practice and policy. As part of the Standardized Outcomes in Nephrology-Children and Adolescents (SONG-Kids) initiative, we convened 2 consensus workshops in San Diego, California (7 patients, 24 caregivers, 43 health professionals) and Melbourne, Australia (7 patients, 23 caregivers, 49 health professionals). This report summarizes the discussions on the identification and implementation of the SONG-Kids core outcomes set. Four themes were identified; survival and life participation are common high priority goals, capturing the whole child and family, ensuring broad relevance across the patient journey, and requiring feasible and valid measures. Stakeholders supported the inclusion of mortality, infection, life participation, and kidney function as the core outcomes domains for children with chronic kidney disease., (Copyright © 2020. Published by Elsevier Inc.)

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-KIDS 2 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 ).