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, 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.

Using co-design to develop the Adolescent Health Literacy Questionnaire for adolescents in Ireland.

Health literacy measurement studies are important for the success of health promotion efforts targeting adolescents. However, the majority of health literacy measurement tools were originally developed for adult populations and may not be reflective of health literacy in the context of adolescence. The present study sought to co-design a health literacy questionnaire and vignettes for adolescents in Ireland aged 12-18 years. This article describes the qualitative phase of the study. In 2019-2021, eight adolescents from the Irish Heart Foundation's Youth Advisory Panel participated in two concept mapping workshops during which they defined healthy living. Results of the thematic analysis indicated that adolescents defined 'healthy living' as a life that was balanced, prioritizing mental health and sleep. According to their definition, healthy living was comprised of six main constructs, namely, knowledge; sources of quality health information; facilitators and barriers; influence of others; self-efficacy, self-management and resilience; and citizenship and communication. These constructs were used to develop vignettes and items for the Adolescent Health Literacy Questionnaire (AHLQ). These were tested on a sample of 80 adolescents to check whether the respondents understood the items and vignettes as intended. Results of the nine cognitive interviews indicated that the adolescents understood the content of the 10 vignettes and 41 items. While the vignettes and AHLQ were developed with Irish adolescents, the approaches taken can be generalized to adolescents living in other countries. This will allow for the development of tailored and relevant solutions for health literacy development and health promotion for this sub-population.

Training healthcare professionals to administer Goal Attainment Scaling as an outcome measure.

BACKGROUND: Goals generated by Goal Attainment Scaling (GAS) can be used as an outcome measure to promote person-centred research and care. There are no training packages which support its use outside of the rehabilitation discipline. This paper describes the development and evaluation of a training package to support the implementation of GAS as an outcome measure in healthcare research. The training package consisted of classroom teaching, a training manual for self-directed learning, one-on-one simulation and hot reviews. It was developed for the GOAL Trial, a randomised controlled trial assessing a Comprehensive Geriatric Assessment's effectiveness in enabling frail older people living with chronic kidney disease to attain their goals. Training participants were invited to complete pre- and post-training online evaluation surveys. RESULTS: Forty-two healthcare professionals attended an initial online classroom teaching, with 27 proceeding to administer GAS to GOAL Trial patients. Response rates for the online pre- and post-training surveys were 95% and 72%, respectively. Prior to training, only 15% of participants reported being able to appropriately scale and troubleshoot GAS goals. Post-training this was 92%. There was 100% participant satisfaction for the training manual, one-on-one simulation, and hot reviews. CONCLUSIONS: This training package helps ensure healthcare professionals administering GAS have adequate knowledge and skills. It has the potential for adoption as a guide to support the implementation of GAS by other researchers seeking to embrace persont-centred principles in their work.

Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol.

BACKGROUND: Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices. METHODS: The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30 days and 180 days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of 2 years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. DISCUSSION: TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections. TRIAL REGISTRATION: ClinicalTrials.gov NCT03816111. Registered on 24 January 2019.

Balanced crystalloid solution versus saline in deceased donor kidney transplantation (BEST-Fluids): a pragmatic, double-blind, randomised, controlled trial.

BACKGROUND: Delayed graft function (DGF) is a major adverse complication of deceased donor kidney transplantation. Intravenous fluids are routinely given to patients receiving a transplant to maintain intravascular volume and optimise graft function. Saline (0·9% sodium chloride) is widely used but might increase the risk of DGF due to its high chloride content. We aimed to test our hypothesis that using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline would reduce the incidence of DGF. METHODS: BEST-Fluids was a pragmatic, registry-embedded, multicentre, double-blind, randomised, controlled trial at 16 hospitals in Australia and New Zealand. Adults and children of any age receiving a deceased donor kidney transplant were eligible; those receiving a multi-organ transplant or weighing less than 20 kg were excluded. Participants were randomly assigned (1:1) using an adaptive minimisation algorithm to intravenous balanced crystalloid solution (Plasma-Lyte 148) or saline during surgery and up until 48 h after transplantation. Trial fluids were supplied in identical bags and clinicians determined the fluid volume, rate, and time of discontinuation. The primary outcome was DGF, defined as receiving dialysis within 7 days after transplantation. All participants who consented and received a transplant were included in the intention-to-treat analysis of the primary outcome. Safety was analysed in all randomly assigned eligible participants who commenced surgery and received trial fluids, whether or not they received a transplant. This study is registered with Australian New Zealand Clinical Trials Registry, (ACTRN12617000358347), and ClinicalTrials.gov (NCT03829488). FINDINGS: Between Jan 26, 2018, and Aug 10, 2020, 808 participants were randomly assigned to balanced crystalloid (n=404) or saline (n=404) and received a transplant (512 [63%] were male and 296 [37%] were female). One participant in the saline group withdrew before 7 days and was excluded, leaving 404 participants in the balanced crystalloid group and 403 in the saline group that were included in the primary analysis. DGF occurred in 121 (30%) of 404 participants in the balanced crystalloid group versus 160 (40%) of 403 in the saline group (adjusted relative risk 0·74 [95% CI 0·66 to 0·84; p<0·0001]; adjusted risk difference 10·1% [95% CI 3·5 to 16·6]). In the safety analysis, numbers of investigator-reported serious adverse events were similar in both groups, being reported in three (<1%) of 406 participants in the balanced crystalloid group versus five (1%) of 409 participants in the saline group (adjusted risk difference -0·5%, 95% CI -1·8 to 0·9; p=0·48). INTERPRETATION: Among patients receiving a deceased donor kidney transplant, intravenous fluid therapy with balanced crystalloid solution reduced the incidence of DGF compared with saline. Balanced crystalloid solution should be the standard-of-care intravenous fluid used in deceased donor kidney transplantation. FUNDING: Medical Research Future Fund and National Health and Medical Research Council (Australia), Health Research Council (New Zealand), Royal Australasian College of Physicians, and Baxter.

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.

Baseline Characteristics and Representativeness of Participants in the BEST-Fluids Trial: A Randomized Trial of Balanced Crystalloid Solution Versus Saline in Deceased Donor Kidney Transplantation.

Delayed graft function (DGF) is a major complication of deceased donor kidney transplantation. Saline (0.9% sodium chloride) is a commonly used intravenous fluid in transplantation but may increase the risk of DGF because of its high chloride content. Better Evidence for Selecting Transplant Fluids (BEST-Fluids), a pragmatic, registry-based, double-blind, randomized trial, sought to determine whether using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline would reduce DGF. We sought to evaluate the generalizability of the trial cohort by reporting the baseline characteristics and representativeness of the trial participants in detail. Methods: We compared the characteristics of BEST-Fluids participants with those of a contemporary cohort of deceased donor kidney transplant recipients in Australia and New Zealand using data from the Australia and New Zealand Dialysis and Transplant Registry. To explore potential international differences, we compared trial participants with a cohort of transplant recipients in the United States using data from the Scientific Registry of Transplant Recipients. Results: During the trial recruitment period, 2373 deceased donor kidney transplants were performed in Australia and New Zealand; 2178 were eligible' and 808 were enrolled in BEST-Fluids. Overall, trial participants and nonparticipants were similar at baseline. Trial participants had more coronary artery disease (standardized difference [d] = 0.09; P = 0.03), longer dialysis duration (d = 0.18, P < 0.001), and fewer hypertensive (d = -0.11, P = 0.03) and circulatory death (d = -0.14, P < 0.01) donors than nonparticipants. Most key characteristics were similar between trial participants and US recipients, with moderate differences (|d| ≥ 0.2; all P < 0.001) in kidney failure cause, diabetes, dialysis duration, ischemic time, and several donor risk predictors, likely reflecting underlying population differences. Conclusions: BEST-Fluids participants had more comorbidities and received slightly fewer high-risk deceased donor kidneys but were otherwise representative of Australian and New Zealand transplant recipients and were generally similar to US recipients. The trial results should be broadly applicable to deceased donor kidney transplantation practice worldwide.

Mechanistically-grounded pathways connect remotely sensed canopy structure to soil respiration.

Variation in the soil-to-atmosphere C flux, or soil respiration (Rs), is influenced by a suite of biotic and abiotic factors, including soil temperature, soil moisture, and root biomass. However, whether light detection and ranging (lidar)-derived canopy structure is tied to soil respiration through its simultaneous influence over these drivers is not known. We assessed relationships between measures of above- and belowground vegetation density and complexity, and evaluated whether Rs is linked to remotely sensed canopy structure through pathways mediated by established biotic and abiotic mechanisms. Our results revealed that, at the stand-scale, canopy rugosity-a measure of complexity-and vegetation area index were coupled to soil respiration through their effects on light interception, soil microclimate, and fine root mass density, but this connection was stronger for complexity. Canopy and root complexity were not spatially coupled at the stand-scale, with canopy but not root complexity increasing through stand development. Our findings suggest that remotely sensed canopy complexity could be used to infer spatial variation in Rs, and that this relationship is grounded in known mechanistic pathways. The broad spatial inference of soil respiration via remotely sensed canopy complexity requires multi-site observations of canopy structure and Rs, which is possible given burgeoning open data from ecological networks and satellite remote sensing platforms.

Using Co-Design to Develop a Health Literacy Intervention with Socially Disadvantaged Adolescents.

The aim of this study was to initiate a co-design process with adolescents to inform the development of a targeted health literacy intervention for implementation in designated socioeconomically disadvantaged post-primary schools in Ireland. Purposely developed vignettes were explored in a series of eight workshops that were conducted separately with staff (n = 26) and students (n = 33) across four schools. Data was analysed using content analysis. A number of key health topics were identified as important and influential for the participants in this context: food choices, mental health and wellbeing, physical activity and sedentary behaviour, sleep and substance misuse. Participants also suggested many health-related capacity building actions. Participants recognized that many of these health topics and capacity building actions were intertwined and also highlighted that some of these actions may be more feasible and/or impactful than others. For example, students and school staff both indicated the need to use relevant, applied and engaging approaches to improve health literacy and subsequent health behaviour. The co-design process adopted empowered stakeholders to actively engage in the design and development of future intervention strategies, which may increase the likelihood of acceptability, effectiveness and sustainability of the resulting intervention.

Food-related inhibitory control training reduces food liking but not snacking frequency or weight in a large healthy adult sample.

Inhibitory control training has recently been used as an intervention to aid healthy eating and encourage weight loss. The aim of this pre-registered study was to explore the effects of training on food liking, food consumption and weight loss in a large (n = 366), predominantly healthy-weight sample. Participants received four training sessions within a week, in which they had to inhibit their responses to either energy-dense foods (active group) or non-food images (control group). Subjective food ratings, food consumption frequency and weight were measured pre- and post-training. At two-weeks post-training, the active group reported a greater reduction in liking for energy-dense foods, compared to the control group. Active participants also reported a significantly greater increase in healthy food liking, immediately post-training, relative to the control group. There was no statistically significant difference between groups for the change in consumption of trained foods or for weight loss. These findings are partially consistent with previous research conducted in smaller, more overweight samples. Exploratory analyses suggest that some effects of training may be driven by awareness effects. Methodological differences across findings and avenues for future investigation are discussed.

Understanding disadvantaged adolescents' perception of health literacy through a systematic development of peer vignettes.

BACKGROUND: Adolescence represents a crucial phase of life where health behaviours, attitudes and social determinants can have lasting impacts on health quality across the life course. Unhealthy behaviour in young people is generally more common in low socioeconomic groups. Nevertheless, all adolescents should have a fair opportunity to attain their full health potential. Health literacy is positioned as a potential mediating factor to improve health, but research regarding health literacy in adolescents and socially disadvantaged populations is limited. As part of Phase one of the Ophelia (OPtimising HEalth LIterAcy) framework, The purpose of this study was to explore the perceptions of socially disadvantaged Irish adolescents in relation to health literacy and related behaviours, and utilise this data to develop relevant vignettes. METHODS: A convergent mixed method design was used to co-create the vignettes. Questionnaires were completed by 962 adolescents (males n = 553, females n = 409, Mean age = 13.97 ± 0.96 years) from five participating disadvantaged schools in Leinster, Ireland. Focus groups were also conducted in each school (n = 31). Results were synthesised using cluster and thematic analysis, to develop nine vignettes that represented typical male and female subgroups across the schools with varying health literacy profiles. These vignettes were then validated through triangular consensus with students, teachers, and researchers. DISCUSSION: The co-creation process was a participatory methodology which promoted the engagement and autonomy of the young people involved in the project. The vignettes themselves provide an authentic and tangible description of the health issues and health literacy profiles of adolescents in this context. Application of these vignettes in workshops involving students and teachers, will enable meaningful engagement in the discussion of health literacy and health-related behaviours in Irish young people, and the potential co-designing of strategies to address health literacy in youth. CONCLUSION: As guided by the Ophelia framework, the use of authentic, interactive and participatory research methods, such as the co-creation of vignettes, is particularly important in groups that are underserved by traditional research methods. The approach used in this study could be adapted to other contexts to represent and understand stakeholders' perceptions of health, with a view to explore, and ultimately improve, health literacy.