Patient and caregiver perspectives on blood pressure in children with chronic kidney disease.

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.

Perspectives of patients, family members, health professionals and the public on the impact of COVID-19 on mental health.

BACKGROUND: The coronavirus (COVID-19) pandemic has seen a global surge in anxiety, depression, post-traumatic stress disorder (PTSD), and stress. AIMS: This study aimed to describe the perspectives of patients with COVID-19, their family, health professionals, and the general public on the impact of COVID-19 on mental health. METHODS: A secondary thematic analysis was conducted using data from the COVID-19 COS project. We extracted data on the perceived causes and impact of COVID-19 on mental health from an international survey and seven online consensus workshops. RESULTS: We identified four themes (with subthemes in parenthesis): anxiety amidst uncertainty (always on high alert, ebb and flow of recovery); anguish of a threatened future (intense frustration of a changed normality, facing loss of livelihood, trauma of ventilation, a troubling prognosis, confronting death); bearing responsibility for transmission (fear of spreading COVID-19 in public; overwhelming guilt of infecting a loved one); and suffering in isolation (severe solitude of quarantine, sick and alone, separation exacerbating grief). CONCLUSION: We found that the unpredictability of COVID-19, the fear of long-term health consequences, burden of guilt, and suffering in isolation profoundly impacted mental health. Clinical and public health interventions are needed to manage the psychological consequences arising from this pandemic.

Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery.

OBJECTIVES: Respiratory failure, multiple organ failure, shortness of breath, recovery, and mortality have been identified as critically important core outcomes by more than 9300 patients, health professionals, and the public from 111 countries in the global coronavirus disease 2019 core outcome set initiative. The aim of this project was to establish the core outcome measures for these domains for trials in coronavirus disease 2019. DESIGN: Three online consensus workshops were convened to establish outcome measures for the four core domains of respiratory failure, multiple organ failure, shortness of breath, and recovery. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Respiratory failure, assessed by the need for respiratory support based on the World Health Organization Clinical Progression Scale, was considered pragmatic, objective, and with broad applicability to various clinical scenarios. The Sequential Organ Failure Assessment was recommended for multiple organ failure, because it was routinely used in trials and clinical care, well validated, and feasible. The Modified Medical Research Council measure for shortness of breath, with minor adaptations (recall period of 24 hr to capture daily fluctuations and inclusion of activities to ensure relevance and to capture the extreme severity of shortness of breath in people with coronavirus disease 2019), was regarded as fit for purpose for this indication. The recovery measure was developed de novo and defined as the absence of symptoms, resumption of usual daily activities, and return to the previous state of health prior to the illness, using a 5-point Likert scale, and was endorsed. CONCLUSIONS: The coronavirus disease 2019 core outcome set recommended core outcome measures have content validity and are considered the most feasible and acceptable among existing measures. Implementation of the core outcome measures in trials in coronavirus disease 2019 will ensure consistency and relevance of the evidence to inform decision-making and care of patients with coronavirus disease 2019.

Patient-reported outcome measures for life participation in peritoneal dialysis: a systematic review.

BACKGROUND: Patients receiving peritoneal dialysis (PD) endure an ongoing regimen of daily fluid exchanges and are at risk of potentially life-threatening complications and debilitating symptoms that can limit their ability to participate in life activities. The aim of the study was to identify the characteristics, content and psychometric properties of measures for life participation used in research in PD. METHODS: We searched MEDLINE, Embase, PsychInfo, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Cochrane Central Register of Controlled Trials from inception to May 2020 for all studies that reported life participation in patients on PD. The characteristics, dimensions of life participation and psychometric properties of these measures were extracted and analyzed. RESULTS: Of the 301 studies included, 17 (6%) were randomized studies and 284 (94%) were nonrandomized studies. Forty-two different measures were used to assess life participation. Of these, 23 (55%) were used in only one study. Fifteen (36%) measures were specifically designed to assess life participation, while 27 (64%) measures assessed broader constructs, such as quality of life, but included questions on life participation. The 36-Item Short Form Health Survey and Kidney Disease Quality of Life Short Form were the most frequently used measures [122 (41%) and 86 (29%) studies, respectively]. Eight (19%) measures had validation data to support their use in patients on PD. CONCLUSIONS: The many measures currently used to assess life participation in patients receiving PD vary in their characteristics, content and validation. Further work to pilot and validate potential measures is required to establish a core patient-reported outcome measure to assess life participation in patients receiving PD.

Kidney transplant recipient perspectives on telehealth during the COVID-19 pandemic.

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.

International Survey to Establish Prioritized Outcomes for Trials in People With Coronavirus Disease 2019.

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.

Core Outcomes Set for Trials in People With Coronavirus Disease 2019.

OBJECTIVES: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019. DESIGN: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set. 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, researchers). INTERVENTIONS: None. MEASUREMENTS: None. MAIN RESULTS: Six themes were identified. "Responding to the critical and acute health crisis" reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. "Capturing different settings of care" highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. "Encompassing the full trajectory and severity of disease" was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). "Distinguishing overlap, correlation and collinearity" meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). "Recognizing adverse events" refers to the potential harms of new and evolving interventions. "Being cognizant of family and psychosocial wellbeing" reflected the pervasive impacts of coronavirus disease 2019. CONCLUSIONS: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials.

Perspectives on mental health among patients receiving dialysis.

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.

Patient- and parent proxy-reported outcome measures for life participation in children with chronic kidney disease: a systematic review.

BACKGROUND: The burden of chronic kidney disease (CKD) and its treatment may severely limit the ability of children with CKD to do daily tasks and participate in family, school, sporting and recreational activities. Life participation is critically important to affected children and their families; however, the appropriateness and validity of available measures used to assess this outcome are uncertain. The aim of this study was to identify the characteristics, content and psychometric properties of existing measures for life participation used in children with CKD. METHODS: We searched MEDLINE, Embase, PsychINFO, Cumulative Index to Nursing and Allied Health Literature and the Cochrane Kidney and Transplant register to August 2019 for all studies that used a measure to report life participation in children with CKD. For each measure, we extracted and analyzed the characteristics, dimensions of life participation and psychometric properties. RESULTS: From 128 studies, we identified 63 different measures used to assess life participation in children with CKD. Twenty-five (40%) of the measures were patient reported, 7 (11%) were parent proxy reported and 31 (49%) had both self and parent proxy reports available. Twenty-two were used in one study only. The Pediatric Quality of Life Inventory version 4.0 generic module was used most frequently in 62 (48%) studies. Seven (11%) were designed to assess ability to participate in life, with 56 (89%) designed to assess other constructs (e.g. quality of life) with a subscale or selected questions on life participation. Across all measures, the three most frequent activities specified were social activities with friends and/or family, leisure activities and self-care activities. Validation data in the pediatric CKD population were available for only 19 (30%) measures. CONCLUSIONS: Life participation is inconsistently measured in children with CKD and the measures used vary in their characteristics, content and validity. Validation data supporting these measures in this population are often incomplete and are sparse. A meaningful and validated measure for life participation in children with CKD is needed.

Meaning of empowerment in peritoneal dialysis: focus groups with patients and caregivers.

BACKGROUND: While peritoneal dialysis (PD) can offer patients more independence and flexibility compared with in-center hemodialysis, managing the ongoing and technically demanding regimen can impose a burden on patients and caregivers. Patient empowerment can strengthen capacity for self-management and improve treatment outcomes. We aimed to describe patients' and caregivers' perspectives on the meaning and role of patient empowerment in PD. METHODS: Adult patients receiving PD (n = 81) and their caregivers (n = 45), purposively sampled from nine dialysis units in Australia, Hong Kong and the USA, participated in 14 focus groups. Transcripts were thematically analyzed. RESULTS: We identified six themes: lacking clarity for self-management (limited understanding of rationale behind necessary restrictions, muddled by conflicting information); PD regimen restricting flexibility and freedom (burden in budgeting time, confined to be close to home); strength with supportive relationships (gaining reassurance with practical assistance, comforted by considerate health professionals, supported by family and friends); defying constraints (reclaiming the day, undeterred by treatment, refusing to be defined by illness); regaining lost vitality (enabling physical functioning, restoring energy for life participation); and personal growth through adjustment (building resilience and enabling positive outlook, accepting the dialysis regimen). CONCLUSIONS: Understanding the rationale behind lifestyle restrictions, practical assistance and family support in managing PD promoted patient empowerment, whereas being constrained in time and capacity for life participation outside the home undermined it. Education, counseling and strategies to minimize the disruption and burden of PD may enhance satisfaction and outcomes in patients requiring PD.

Suspension and resumption of kidney transplant programmes during the COVID-19 pandemic: perspectives from patients, caregivers and potential living donors - a qualitative study.

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.

Patient Perspectives on the Meaning and Impact of Fatigue in Hemodialysis: A Systematic Review and Thematic Analysis of Qualitative Studies.

RATIONALE & OBJECTIVE: Fatigue is a highly prevalent and debilitating symptom in patients on hemodialysis therapy due to the uremic milieu, the hemodialysis treatment itself, and other comorbid conditions. However, fatigue remains underrecognized and the consequences are underappreciated because it may not be visible in clinical settings. This study aims to describe the experience that patients undergoing maintenance hemodialysis have with fatigue. STUDY DESIGN: Systematic review and thematic synthesis of qualitative studies. SETTING & STUDY POPULATIONS: Patients undergoing hemodialysis. SEARCH STRATEGY & SOURCES: MEDLINE, Embase, PsycINFO, CINAHL, reference lists, and PhD dissertations were searched from inception to October 2018. DATA EXTRACTION: All text from the results/conclusion of the primary studies. ANALYTICAL APPROACH: Thematic synthesis. RESULTS: 65 studies involving 1,713 participants undergoing hemodialysis were included. We identified 4 themes related to fatigue: debilitating and exhausting burden of dialysis (bodily depletion, trapped in a vicious cycle of postdialysis exhaustion, vigilance and worry inhibiting rest, tiresome and agonizing regimen, and without remedy and relief), restricted life participation (deprived of time, managing energy reserves, frustrating need to rest, and joys foregone), diminishing capacities to fulfil relationship roles (losing ability to work and provide for family, failing as a parent, lacking stamina for sexual intimacy, and relying on others), and vulnerable to misunderstanding (being criticized for the need to rest and failing to meet expectations). LIMITATIONS: Non-English articles were excluded and most studies were conducted in high-income countries. CONCLUSIONS: For patients undergoing hemodialysis who experience fatigue, fatigue is a profound and relentless exhaustion that pervades the entire body and encompasses weakness. The fatigue drains vitality in patients and constrains their ability to do usual activities and fulfill their roles and meet personal aspirations. Explicit recognition of the impact of fatigue and establishing additional effective interventions to improve fatigue are needed.

Reporting guideline for priority setting of health research (REPRISE).

BACKGROUND: Research priority setting with stakeholders can help direct the limited resources for health research toward priority areas of need. Ensuring transparency of the priority setting process can strengthen legitimacy and credibility for influencing the research agenda. This study aims to develop a reporting guideline for priority setting of health research. METHODS: We searched electronic databases and relevant websites for sources (frameworks, guidelines, or models for conducting, appraising, reporting or evaluating health research priority setting, and reviews (including systematic reviews)), and primary studies of research priority setting to July 2019. We inductively developed a list of reporting items and piloted the preliminary guideline with a diverse range of 30 priority setting studies from the records retrieved. RESULTS: From 21,556 records, we included 26 sources for the candidate REPRISE framework and 455 primary research studies. The REporting guideline for PRIority SEtting of health research (REPRISE) has 31 reporting items that cover 10 domains: context and scope, governance and team, framework for priority setting, stakeholders/participants, identification and collection of priorities, prioritization of research topics, output, evaluation and feedback, translation and implementation, and funding and conflict of interest. Each reporting item includes a descriptor and examples. CONCLUSIONS: The REPRISE guideline can facilitate comprehensive reporting of studies of research priority setting. Improved transparency in research priority setting may strengthen the acceptability and implementation of the research priorities identified, so that efforts and funding are invested in generating evidence that is of importance to all stakeholders. TRIAL REGISTRATION: Not applicable.

Australian Workshops on Patients' Perspectives on Hemodialysis and Incremental Start.

Introduction: Most patients with kidney failure commence and continue hemodialysis (HD) thrice weekly. Incremental initiation (defined as HD less than thrice weekly) is increasingly considered to be safe and less burdensome, but little is known about patients' perspectives. We aimed to describe patients' priorities and concerns regarding incremental HD. Methods: Patients currently, previously, or soon to be receiving HD in Australia participated in two 90-minute online workshops to discuss views about HD focusing on incremental start and priorities for trial outcomes. Transcripts were analyzed using thematic analysis. Outcomes were ranked on the basis of the sum of participants' priority scores (i.e., single allocation of 3 points for most important, 2 for second, and 1 for third most important outcome). Results: All 26 participants (1 caregiver and 25 patients) preferred an incremental HD approach. The top prioritized outcomes were quality of life (QOL) (56 points), residual kidney function (RKF) (27 points), and mortality (16 points). The following 4 themes underpinning outcome priorities, experience, and safety concerns were identified: (i) unpreparedness and pressure to adapt, (ii) disruption to daily living, (iii) threats to safety, and (iv) hope and future planning. Conclusion: Patients with kidney failure preferred an incremental start to HD to minimize disruption to daily living and reduce the negative impacts on their education, ability to work, and family life. QOL was the most critically important outcome, followed by RKF and survival.

Nephrologists' Perspectives on Gender Disparities in CKD and Dialysis.

Introduction: Globally, there are more women with chronic kidney disease (CKD), yet they comprise only 40% of patients receiving kidney replacement therapy by dialysis. We aimed to describe the perspectives of nephrologists on gender disparities in access to care and outcomes in CKD and dialysis. Methods: We conducted semistructured interviews with 51 nephrologists (28, 55% women) from 22 countries from October 2019 to April 2020. Transcripts were analyzed thematically. Results: We identified 6 themes. Related to women were primary commitment to caregiving (with subthemes of coordinating care, taking charge of health management, deprioritizing own health, centrality of family in decision-making); vigilance and self-reliance (diligence and conscientiousness, stoicism and tolerating symptoms, avoiding burden on family, isolation and coping alone); and stereotyping, stigma, and judgment (body image, dismissed as anxiety, shame and embarrassment, weakness and frailty). Related to men was protecting masculinity (safeguarding the provider role, clinging to control, self-regard, and entitled). Decisional power and ownership included men's dominance in decision-making and women's analytical approach in treatment decisions. Inequities compounded by social disadvantage (financial and transport barriers, without social security, limited literacy, entrenched discrimination, vulnerability) were barriers to care for women, particularly in socioeconomically disadvantaged communities. Conclusion: Nephrologists perceived that women with CKD faced many challenges in accessing care related to social norms and roles of caregiving responsibilities, disempowerment, lack of support, stereotyping by clinicians, and entrenched social and economic disadvantage. Addressing power differences, challenging systemic patriarchy, and managing unconscious bias may help to improve equitable care and outcomes for all people with CKD.

A Web-Based Alcohol and Other Drug Prevention Program (Strong & Deadly Futures) for Aboriginal and Torres Strait Islander School Students: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: There are no available school-based alcohol and drug prevention programs with evidence of effectiveness among Aboriginal and Torres Strait Islander youth. To address this, we codeveloped the Strong & Deadly Futures well-being and alcohol and drug prevention program in partnership with an Indigenous creative design agency and 4 Australian schools. OBJECTIVE: This paper presents the protocol to evaluate the effectiveness of Strong & Deadly Futures in reducing alcohol and other drug use and improving well-being among Aboriginal and Torres Strait Islander youth. METHODS: The target sample will be 960 year 7 and 8 students from 24 secondary schools in Australia, of which approximately 40% (384/960) will identify as Aboriginal or Torres Strait Islander. The study design is a 2-group, parallel cluster randomized controlled trial with allocation concealment. Recruited schools will be block randomized (ratio 1:1), stratified by geographical remoteness, by an independent statistician. Schools will be randomized to receive Strong & Deadly Futures, a web-based alcohol and drug prevention and social and emotional well-being program that delivers curriculum-aligned content over 6 lessons via an illustrated story, or health education as usual (control). Control schools will be supported to implement Strong & Deadly Futures following trial completion. Surveys will be administered at baseline, 6 weeks, 12 months, and 24 months (primary end point) post baseline. Primary outcomes are alcohol use (adapted from the National Drug Strategy Household Survey), tobacco use (Standard High School Youth Risk Behavior Survey), and psychological distress (Kessler-5 Psychological Distress Scale). Secondary outcomes are alcohol and drug knowledge and intentions, alcohol-related harms, binge drinking, cannabis use, well-being, empowerment, appreciation of cultural diversity, and truancy. RESULTS: The trial was funded by the National Health and Medical Research Council in January 2019, approved by the Human Research Ethics Committee of the University of Sydney (2020/039, April 2020), the Aboriginal Health and Medical Research Council of New South Wales (1620/19, February 2020), the Western Australian Aboriginal Health Ethics Committee (998, October 2021), and the ethics committees of each participating school, including the New South Wales Department of Education (2020170, June 2020), Catholic Education Western Australia (RP2020/39, November 2020), and the Queensland Department of Education (550/27/2390, August 2021). Projected dates of data collection are 2022-2024, and we expect to publish the results in 2025. A total of 24 schools have been recruited as of submission of the manuscript. CONCLUSIONS: This will be the first cluster randomized controlled trial of a culturally inclusive, school-based alcohol and drug prevention program for Aboriginal and Torres Strait Islander youth; therefore, it has significant potential to address alcohol and other drug harms among Aboriginal and Torres Strait Islander youth. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001038987; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380038&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/34530.

Perspectives on ability to work from patients' receiving dialysis and caregivers: analysis of data from the global SONG initiative.

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.

Establishing a core outcome measure for life participation in patients receiving peritoneal dialysis: A Standardised Outcomes in Nephrology-Peritoneal Dialysis consensus workshop report.

BACKGROUND: Life participation is an outcome of critical importance to patients receiving peritoneal dialysis (PD). However, there is no widely accepted or validated tool for measuring life participation in patients receiving PD. METHODS: Online consensus workshop to identify the essential characteristics of life participation as a core outcome, with the goal of establishing a patient-reported outcome measure for use in all trials in patients receiving PD. Thematic analysis of transcripts was performed. RESULTS: Fifty-six participants, including 17 patients and caregivers, from 15 countries convened via online videoconference. Four themes were identified: reconfiguring expectations of daily living (accepting day-to-day fluctuation as the norm, shifting thresholds of acceptability, preserving gains in flexibility and freedom), ensuring broad applicability and interpretability (establishing cross-cultural relevance, incorporating valued activities, distinguishing unmodifiable barriers to life participation), capturing transitions between modalities and how they affect life participation (responsive to trajectory towards stable, reflecting changes with dialysis transitions) and maximising feasibility of implementation (reducing completion burden, administrable with ease and flexibility). CONCLUSIONS: There is a need for a validated, generalisable outcome measure for life participation in patients receiving PD. Feasibility, including length of time to complete and flexible mode of delivery, are important to allow implementation in all trials that include patients receiving PD.

Establishing a Core Outcome Measure for Peritoneal Dialysis-related Peritonitis: A Standardized Outcomes in Nephrology-Peritoneal Dialysis Consensus Workshop Report.

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