Improving Diverse and Equitable Involvement of Patients and Caregivers in Research in CKD: Report of a Better Evidence and Translation - Chronic Kidney Disease (BEAT-CKD) Workshop.

Patient and caregiver involvement can enhance the uptake and impact of research, however, 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 CKD and caregivers is needed. We conducted a national workshop involving patients, caregivers, clinicians and researchers 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 andsupport 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.

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

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

Supporting Physical Activity Maintenance in Older Adults Following Supervised Group Exercise: A Mixed-Methods Study Among Culturally Diverse Older Adults.

Physical activity (PA) is important for prevention of falls and chronic disease in older adults. We aimed to examine the interrelated influences upon PA in culturally diverse older adults who completed a short-term exercise program, to inform maintenance strategies, using a mixed-methods design. Eighty-two past participants from the "Stepping On"© program were surveyed examining ongoing participation, social and cognitive determinants of PA, mental and physical functioning, and fear of falls. Semi-structured interviews were undertaken with 34 respondents regarding enablers and barriers, cultural factors, and preferences for PA. Data were collected in English, Chinese, Arabic, Punjabi, or Hindi. Cultural factors minimally affected PA participation. There was low perceived availability of PA opportunities. Health difficulties not only discouraged but also motivated participation. Social connection was a facilitator and could be used to support maintenance. Older adults may benefit from assistance in accessing PA opportunities and clinical guidance about the benefits of ongoing PA.

The Burden of Home Dialysis: An Overlooked Challenge.

Home dialysis offers several clinical and quality-of-life benefits for patients with kidney failure. However, it is important to recognize that home dialysis may place an increased burden on patients and their care partners. Sources of burden may include concerns about the ability to adequately and safely perform dialysis at home, physical symptoms, impairment of life participation, psychosocial challenges, and care partner burnout. Overlooking or failing to address these issues may lead to adverse events that negatively affect health and quality of life and reduce longevity of home dialysis. This study will explore aspects of home dialysis associated with burden, emphasize the need for increased awareness of potential challenges, and elaborate on strategies to overcome sources of burden. Future research should actively involve patients and care partners to better understand their motivation, experiences, and needs to better inform support strategies.

Sport Participation for Academic Success: Evidence From the Longitudinal Study of Australian Children.

BACKGROUND: We aimed to identify long-term patterns of sport participation (overall, team, and individual sport) from childhood into adolescence, and to examine the association between these patterns and academic outcomes. METHODS: This cohort study used data from the Longitudinal Study of Australian Children in wave 3 (4-5 y) to wave 9 (20-21 y). The participants were a nationally representative sample of 4241 children. We conducted latent class analyses to identify sport participation trajectories and assessed the association between these trajectories and academic outcomes. RESULTS: Continued sport participation was associated with lower odds of being absent from school (OR = 0.44; 95% confidence intervals [CIs], 0.26 to 0.74), better performance on attention (B = -0.010; 95% CIs, -0.019 to -0.002) and working memory (B = -0.013; 95% CIs, -0.023 to -0.003), higher numeracy (B = 20.21; 95% CIs, 14.56 to 25.86) and literacy scores (B = 9.42; 95% CIs, 2.82 to 16.02), higher end of school academic performance (B = 3.28; 95% CIs, 1.47 to 5.09), and higher odds of studying at university (OR = 1.78; 95% CIs, 1.32 to 2.40). Team sport participation was associated with reduced absenteeism, better performance on attention and working memory, and being awarded the Higher School Certificate. Whereas individual sport participation was associated with higher literacy scores and end of school academic performance. CONCLUSIONS: Team and individual sport participation both benefit academic outcomes, but differently. Given the decline in sport participation during adolescence, these findings highlight the need to develop educational policies to establish an environment that promotes sport participation, which in turn could improve academic outcomes.

Effects of customer relationship management (CRM) strategies and socio-cognitive constructs on the physical activity of individuals with arthritis over time.

BACKGROUND: Regular physical activity is important for arthritis self-management and could be promoted through tailoring community leisure and fitness centers' customer-relationship management (CRM) strategies. OBJECTIVES: This study investigates the influence of two CRM strategies on individuals with arthritis reaching or maintaining two moderate-to-vigorous physical activity (MVPA) thresholds (≥150 and ≥45 minutes/week) from baseline-to-12 months and 12-to-24 months as well as mean changes in total minutes/week of MVPA. It also explores time-dependent variations in the influence of socio-cognitive variables on MVPA outcomes. METHODS: Survey data from 374 participants with arthritis in a two-year randomized controlled trial (control versus two CRM strategies: IncentiveOnly and Incentive+Support) were used. Participants reported measures of physical activity participation, socio-cognitive decision-making, mental and physical wellbeing, friendship, community connectedness, sense of trust in others, and demographics. FINDINGS/DISCUSSION: Receiving the Incentive+Support CRM strategy (versus control) increased participants' likelihood of reaching/maintaining both physical activity thresholds from 12-to-24 months (≥150 MVPA minutes/week, p < .001; ≥45 MVPA minutes/week, p < .032) but not from baseline-to-12 months. However, receiving the IncentiveOnly CRM strategy (versus control) did not predict reaching/maintaining these thresholds. Importantly, socio-cognitive decision-making variables' influence on reaching/maintaining these MVPA thresholds varied over time, suggesting CRM strategies may require further tailoring based on time-specific profiles. Perhaps because of new facility induced excitement, the mean change in total MVPA minutes/week for the control group significantly increased (26.8 minute/week, p = .014, 95% CI [5.5, 48.0]) from baseline-to-12 months, but subsequently declined by 11.4 minute/week from 12-to-24 months (p = .296, 95% CI [-32.7, 9.9]). Mean changes in total MVPA minutes/week were non-significant for those receiving IncentiveOnly content but significant for those receiving Incentive+Support content: baseline-to-12 months (38.2 minute/week increase, p = .023, 95% CI [4.9, 71.4]) and baseline-to-24-months (45.9 minute/week increase, p = .007, 95% CI [12.7, 79.1]).

The prevalence of chronic and episodic loneliness and social isolation from a longitudinal survey.

Loneliness and social isolation, experienced more long-term, has been shown to increase mortality and lead to poorer health outcomes in specific cohorts. However, it is unclear what the prevalence of chronic loneliness and social isolation is, and which demographic groups are most at risk of reporting more chronic forms. A psychometrically validated classification system was used to identify people who met criteria for episodic and chronic loneliness and social isolation using the Household Income and Labour Dynamics in Australia (HILDA) survey waves 14-18. The prevalence of loneliness (overall 34%; 21% episodic, 13% chronic) far exceeded that of social isolation (overall 17%; 13% episodic, 4% chronic). There was consistency in the demographic characteristics (from age, sex, household type, income) of those who experienced loneliness and social isolation. However, people with a long-term health condition had an elevated risk of episodic loneliness (AOR 1.24, 95% CI 1.11-1.39) and a markedly higher risk of chronic loneliness (AOR 2.01, 95% CI 1.76-2.29), compared with those without a long-term health condition. Loneliness, both episodic and chronic subtypes, is more prevalent than social isolation. However, both chronic loneliness and social isolation remains neglected and poorly targeted within current practice and policy.

Range and consistency of gastrointestinal outcomes reported in peritoneal dialysis trials: A systematic review.

BACKGROUND: Gastrointestinal (GI) health is considered vital to the success of peritoneal dialysis (PD) and is critically important to patients, caregivers and clinicians. However, the multiplicity of GI outcome measures in trials undermines the ability to evaluate the frequency, impact and treatment of GI symptoms in patients receiving PD. Therefore, this study aimed to assess the range and consistency of GI outcomes reported in contemporary PD trials. STUDY DESIGN: Systematic review. SETTING AND POPULATION: Individuals with kidney failure requiring PD. SELECTION CRITERIA: All randomised controlled trials involving patients on PD, identified from the PUBMED, EMBASE and COCHRANE Central Registry of controlled Trials (CENTRAL) database, from January 2010 to July 2022. INTERVENTIONS: Any PD-related intervention. OUTCOMES: The frequency and characteristics of GI outcome measures were analysed and classified. RESULTS: Of the 324 eligible PD trials, GI outcomes were only reported in 61 (19%) trials, mostly as patient-reported outcomes (45 trials; 74%). The most frequently reported outcomes were nausea in 27 (43%), diarrhoea in 26 (43%), vomiting in 22 (36%), constipation in 21 (34%) and abdominal pain in 19 (31%) of trials. PD peritonitis was the primary non-GI outcome reported in 24 (40%) trials, followed by death in 13 (21%) trials) and exit-site infection in 9 (15%) trials). Across all trials, 172 GI outcome measures were extracted and grouped into 29 different outcomes. Nausea and diarrhoea contributed to 16% and 15% of GI outcomes, respectively, while vomiting, constipation and abdominal pain contributed to 13%, 12% and 12%, respectively. Most (90%) GI outcomes were patient-reported adverse effects with no defined metrics. Faecal microbiome was reported as the primary study outcome in 3 (100%) trials using the subjective global assessment score, GI symptom rating scale and faecal microbiological and biochemical analysis. Two trials reported nausea as a primary study outcome using symptom assessment score (SAS) and kidney disease quality of life-short-form-36. One trial each reported anorexia and abdominal pain as the primary study outcome using SAS. Bowel habits, constipation and stool type were also reported as the primary study outcome in one trial each using the Bristol stool form scale. GI bleeding was reported as the secondary outcome in three (37%) out of eight trials reporting it. LIMITATIONS: Restricted sampling frame to focus on contemporary trials. CONCLUSIONS: Despite the clinical importance of GI outcomes among patients on PD, they are reported in only 19% of PD trials, using inconsistent metrics, often as patient-reported adverse events. Efforts to standardise GI outcome reporting are critical to optimising comparability, reliability and value of trial evidence to improve outcomes for patients receiving PD.

Joint associations of social health and movement behaviours with mortality and cardiovascular disease: an analysis of 497,544 UK biobank participants.

BACKGROUND: Poor physical activity and excessive sedentary behaviour are well-established risk factors for morbidity and mortality. In the presence of emerging social problems, including loneliness and social isolation, these risks may be even greater. We aimed to investigate the joint effects of social health and movement behaviours on mortality and cardiovascular disease (CVD). METHODS: 497,544 UK Biobank participants were followed for an average of 11 years. Loneliness and social isolation were measured via self-report. Physical activity was categorised around current World Health Organisation (WHO) guidelines as low (< 600 metabolic equivalent of task [MET]-mins/week), moderate (600 < 1200) and high (≥ 1200). Sedentary behaviour was classified as low (≤ 3.5 h/day), moderate (3.5 ≤ 5) and high (> 5.5). We derived 24 social health-movement behaviour combinations, accordingly. Mortality and hospitalisations were ascertained to May 2020 for all-cause and CVD mortality, and non-fatal cardiovascular events. RESULTS: Social isolation amplified the risk of both all-cause and CVD death across all physical activity and sedentary levels (hazard ratio, 95% confidence interval [HR, 95% CIs] for all-cause mortality; 1.58 [1.49 to 1.68] for low active-isolated vs. 1.26 [1.22 to 1.30] for low active-not isolated). Loneliness was only found to amplify the risk of death from cardiovascular disease among the high active and low sedentary participants. Loneliness and social isolation did not add to the risk of non-fatal cardiovascular events across most activity levels. CONCLUSION: The detrimental associations of poor physical activity and sedentary behaviour with mortality were consistently amplified by social isolation. Our study supports the need to target the socially isolated as a priority group in preventive public health strategies.

Perspectives of a proposed patient navigator programme for people with chronic kidney disease in rural communities: Report from national workshops.

AIMS: People who live in rural areas have reduced access to appropriate and timely healthcare, leading to poorer health outcomes than their metropolitan-based counterparts. The aims of the workshops were to ascertain participants' perspectives on barriers to access to dialysis and transplantation, to identify and prioritize the roles of a rural patient navigator, to discuss the acceptability and feasibility of implementing this role and identify possible outcomes that could be used to measure the success of the programme in a clinical trial. METHODS: Rural patients (n = 19), their caregivers (n = 5) and health professionals (n = 18) from Australia participated in three workshops. We analysed the data using thematic analysis. RESULTS: We identified four themes related to access to dialysis and transplantation: overwhelmed by separate and disconnected health systems, unprepared for emotional toll and isolation, lack of practical support and inability to develop trust and rapport. Four themes related to the role of the patient navigator programme: valuing lived experience, offering cultural expertise, requiring a conduit, and flexibility of the job description. The key roles prioritized by participants were psychological support and networking, provision/consolidation of education, and provision of practical support. CONCLUSION: Rural patients, caregivers and health professionals believed that programmes that include navigators with lived experience of dialysis and kidney transplantation and cultural expertise, especially for Aboriginal Australians, may have the potential to improve patient experiences in accessing healthcare.

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.

The critical role of mixed methods research in developing valid and reliable patient-reported outcome measures.

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.

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.

Psychometric assessment of scales for measuring loneliness and social isolation: an analysis of the household, income and labour dynamics in Australia (HILDA) survey.

BACKGROUND: Loneliness and social isolation are increasingly recognised as global public health threats, meaning that reliable and valid measures are needed to monitor these conditions at a population level. We aimed to determine if robust and practical scales could be derived for conditions such as loneliness and social isolation using items from a national survey. METHODS: We conducted psychometric analyses of ten items in two waves of the Household, Income and Labour Dynamics in Australia Survey, which included over 15,000 participants. We used the Hull method, exploratory structural equation modelling, and multidimensional item response theory analysis in a calibration sample to determine the number of factors and items within each factor. We cross-validated the factor structure using confirmatory factor analysis in a validation sample. We assessed construct validity by comparing the resulting sub-scales with measures for psychological distress and mental well-being. RESULTS: Calibration and cross-validation consistently revealed a three-factor model, with sub-scales reflecting constructs of loneliness and social isolation. Sub-scales showed high reliability and measurement invariance across waves, gender, and age. Construct validity was supported by significant correlations between the sub-scales and measures of psychological distress and mental health. Individuals who met threshold criteria for loneliness and social isolation had consistently greater odds of being psychologically distressed and having poor mental health than those who did not. CONCLUSIONS: These derived scales provide robust and practical measures of loneliness and social isolation for population-based research.