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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]

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. [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]

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. [ABSTRACT FROM AUTHOR]

• To be relevant clinical trials must report outcomes that are critically important to patients and clinicians including patient reported outcomes. • Patient reported outcomes must be supported by valid and reliable measures. • Validity and reliability requires the application of research methods that include quantitative and qualitative techniques. • Patient reported outcome measures are critical to providing evidence to support clinical guidelines and patient centred care. 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. [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]

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: 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.)