Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation:A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals

Background: Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision-making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. Methods: In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During Round 2 and 3, participants re-rated the outcomes after reviewing their own score, the distribution of the respondents’ scores, and comments. We calculated the median, mean, and proportion rating 7-9 (critically important), and analyzed comments thematically. Results: 1018 participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed Round 1, and 779 (77%) completed Round 3. The top eight outcomes that met the consensus criteria in Round 3 (mean ≥7.5, median ≥8 and proportion >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin) and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to six outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified five themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. Conclusions: Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation

Cannulation practices at haemodialysis initiation via an arteriovenous fistula or arteriovenous graft

Introduction: A functioning long-term vascular access is required for haemodialysis therapy; however, establishing this can be challenging in the setting of advanced age and vessels damaged by diabetes. Complications include the inability to insert two needles for the treatment resulting in miscannulation trauma and in some cases insertion of a temporary central venous access device. The broad objective of this review is to define the evidence base regarding cannulation practices in the initiation of haemodialysis via an arteriovenous fistula or an arteriovenous graft. Methods: This review uses the framework recommended by the Joanna Briggs Institute and the process by which papers were included or excluded followed the standard Preferred Reporting Items for Systematic Reviews and Meta-Analyses group approach. A total of 20 primary research studies met the inclusion criteria. Results: Cannulation in the 10- to 15-week period rather than delaying past this time frame is associated with the best outcomes. New vascular access given time to mature through single-needle haemodialysis treatments may improve long-term patency. Duplex ultrasound mapping prior to initiation of cannulation supports the clinical decision-making process on timing of and selection of cannulation sites. Conclusion: Cannulation trauma at the initiation of haemodialysis could potentially be reduced with a strategy of incremental haemodialysis using single-needle treatment supported with duplex ultrasonography assessment to ‘map’ the vascular access as a guide for clinicians prior to cannulation initiation

Development of the Consumer Involvement & Engagement Toolkit: a digital resource to build capacity for undertaking patient-centred clinical trials in Australia

Objective: This manuscript describes the novel approach to developing a toolkit to support meaningful consumer involvement in clinical trials in Australia to help guide others in considering the development of similar resources.The toolkit aims to support greater consumer involvement in shaping how clinical research is prioritised, designed and conducted. Type of program or service: A working group of researchers, research organisations and consumers was established to co-develop the Consumer Involvement and Engagement Toolkit (the ‘Toolkit’), a digital resource to guide researchers and organisations regarding consumer involvement in clinical trials. Findings: A literature review and international scan of best practice revealed numerous resources outlining best practice for consumer involvement in clinical research and clear evidence of its impact and value. Through a novel content-sharing process, we were able to utilise these resources to develop a comprehensive Toolkit for researchers and research organisations that provides world-class guidance. Lessons learnt: There is a growing movement to ensure consumer involvement in healthcare, including in clinical research. We discovered its proponents were willing to share their tools and resources to promote international consumer involvement. Although these international tools and resources needed adaptation to suit the Australian research environment, this was achievable with far less effort than developing them from scratch

Recommendations for culturally safe clinical kidney care for First Nations Australians: a guideline summary

Introduction: First Nations Australians display remarkable strength and resilience despite the intergenerational impacts of ongoing colonisation. The continuing disadvantage is evident in the higher incidence, prevalence, morbidity and mortality of chronic kidney disease (CKD) among First Nations Australians. Nationwide community consultation (Kidney Health Australia, Yarning Kidneys, and Lowitja Institute, Catching Some Air) identified priority issues for guideline development. These guidelines uniquely prioritised the knowledge of the community, alongside relevant evidence using an adapted GRADE Evidence to Decision framework to develop specific recommendations for the management of CKD among First Nations Australians. Main recommendations: These guidelines explicitly state that health systems have to measure, monitor and evaluate institutional racism and link it to cultural safety training, as well as increase community and family involvement in clinical care and equitable transport and accommodation. The guidelines recommend earlier CKD screening criteria (age ≥ 18 years) and referral to specialists services with earlier criteria of kidney function (eg, estimated glomerular filtration rate [eGFR], ≤ 45 mL/min/1.73 m2, and a sustained decrease in eGFR, \u3e 10 mL/min/1.73 m2 per year) compared with the general population. Changes in management as result of the guidelines: Our recommendations prioritise health care service delivery changes to address institutional racism and ensure meaningful cultural safety training. Earlier detection of CKD and referral to nephrologists for First Nations Australians has been recommended to ensure timely implementation to preserve kidney function given the excess burden of disease. Finally, the importance of community with the recognition of involvement in all aspects and stages of treatment together with increased access to care on Country, particularly in rural and remote locations, including dialysis services

An international Delphi survey helped develop consensus-based core outcome domains for trials in peritoneal dialysis

Shared decision-making about clinical care options in end-stage kidney disease is limited by inconsistencies in the reporting of outcomes and the omission of patient-important outcomes in trials. Here we generated a consensus-based prioritized list of outcomes to be reported during trials in peritoneal dialysis (PD). In an international, online, three-round Delphi survey, patients/caregivers and health professionals rated the importance of outcomes using a 9-point Likert scale (with 7-9 indicating critical importance) and provided comments. Using a Best-Worst Scale (BWS), the relative importance of outcomes was estimated. Comments were analyzed thematically. In total, 873 participants (207 patients/caregivers and 666 health professionals) from 68 countries completed round one, 629 completed round two and 530 completed round three. The top outcomes were PD-related infection, membrane function, peritoneal dialysis failure, cardiovascular disease, death, catheter complications, and the ability to do usual activities. Compared with health professionals, patients/caregivers gave higher priority to six outcomes: blood pressure (mean difference, 0.4), fatigue (0.3), membrane function (0.3), impact on family/friends (0.1), peritoneal thickening (0.1) and usual activities (0.1). Four themes were identified that underpinned the reasons for ratings: contributing to treatment longevity, preserving quality of life, escalating morbidity, and irrelevant and futile information and treatment. Patients/caregivers and health professionals gave highest priority to clinical outcomes. In contrast to health professionals, patients/caregivers gave higher priority to lifestyle-related outcomes including the impact on family/friends and usual activities. Thus, prioritization will inform a core outcome set to improve the consistency and relevance of outcomes for trials in PD

“Can I go to Glasgow?” Learnings from patient involvement at the 17th Congress of the International Society for Peritoneal Dialysis (ISPD)

Background: Recognition of the discrepancy between the research priorities of patients and health professionals has prompted efforts to involve patients as active contributors in research activities, including scientific conferences. However, there is limited evidence about the experience, challenges, and impacts of patient involvement to inform best practice. This study aims to describe patient and health professional perspectives on patient involvement at the Congress of the International Society for Peritoneal Dialysis (ISPD). Methods: Semi-structured interviews were conducted with 14 patients/caregivers and 15 health professionals from six countries who attended ISPD. Interviews were recorded and transcribed verbatim, and transcripts were analyzed thematically. Results: We identified four themes: protecting and enhancing scientific learning (grounding science in stories, sharing and inspiring new perspectives, distilling the key messages of research presentations, striking a balance between accommodating patients and presenting the science); democratizing access to research (redistributing power, challenging the traditional ownership of knowledge, cultivating self-management through demystifying research); inadequate support for patient/caregiver delegates (lacking purposeful inclusion, challenges in interpreting research findings, soliciting medical advice, difficulty negotiating venue and program, limited financial assistance in attending); and amplifying impact beyond the room (sparking innovation in practice, giving patients and families hope for the future). Conclusions: Patient involvement at the ISPD Congress clarified the applicability of research to patient care and self-management, democratized science, and strengthened the potential impact of research. More structured support for patients to help them purposefully articulate their experience in relation to session objectives may enhance their contribution and their own learning experience

Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation

BackgroundInconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals.MethodsIn a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically.ResultsOne thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, ≥7.5; median, ≥8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps.ConclusionsGraft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation