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Chronic inflammation is highly prevalent among patients receiving maintenance hemodialysis and is associated with morbidity and mortality. Inhibiting inflammation with anti-cytokine therapy has been proposed but not well studied in this population. Therefore, we conducted the ACTION trial, a pilot, multicenter, randomized, placebo-controlled trial of an IL-1 receptor antagonist, anakinra, to evaluate safety, tolerability, and feasibility, and explore efficacy. Eighty hemodialysis patients with plasma concentrations of high sensitivity C-reactive protein (hsCRP) 2 mg/L and above were randomized 1:1 to placebo or anakinra 100 mg, three times per week via the hemodialysis circuit for 24 weeks, with an additional 24 weeks of post-treatment safety monitoring. Efficacy outcomes included changes in hsCRP (primary), cytokines, and patient-reported outcomes. Rates of serious adverse events and deaths were similar with anakinra and placebo (serious adverse events: 2.71 vs 2.74 events/patient-year; deaths: 0.12 vs 0.22 events/patient-year). The rate of adverse events of interest (including infections and cytopenias) was significantly lower with anakinra than placebo (0.48 vs 1.40 events/patient-year). Feasibility was demonstrated by attaining the enrollment target, a retention rate of 80%, and administration of 72% of doses. The median decrease in hsCRP from baseline to Week 24 was 41% in the anakinra group and 6% in the placebo group, a between-group difference that was not statistically significant. For IL-6, the median decreases were significant: 25% and 0% in the anakinra and placebo groups, respectively. An effect of anakinra on patient-reported outcomes was not evident. Thus, anakinra was well tolerated and did not increase infections or cytopenias. The promising safety data and potential efficacy on CRP and IL-6 provide support for conducting definitive trials of IL-1 inhibition to improve outcomes in hemodialysis patients.

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.

To compare risk-adjusted 1-year mortality between Medicare Advantage (MA) and traditional Medicare (TM) enrollees with kidney failure who initiated dialysis.Longitudinal analysis of mortality and enrollment data for Medicare beneficiaries.The study compared mortality between MA and TM enrollees with kidney failure who initiated dialysis in 2016, accounting for their enrollment switches between MA and TM during 12 months prior to dialysis initiation. Analyses were adjusted for risk scores and fixed effects for the month of dialysis initiation and county of residence.The difference in risk-adjusted 1-year mortality between MA stayers (Medicare beneficiaries who were continuously enrolled in MA prior to dialysis initiation) and TM stayers (those who were continuously enrolled in TM prior to initiating dialysis) was -0.1 percentage points (95% CI, -1.0 to 0.8); however, the difference increased to -1.0 percentage points (95% CI, -3.2 to 1.2) when comparing TM-to-MA switchers (those who switched from TM to MA before initiation) with TM stayers, a comparison more prone to favorable selection bias given our finding that TM-to-MA switchers were healthier than MA stayers.Among Medicare beneficiaries with kidney failure who initiated dialysis, risk-adjusted 1-year mortality rate is not different between MA and TM stayers. If there is remaining favorable selection in MA due to unobserved health status, our finding provides a lower-bound estimate of the MA impact on mortality among beneficiaries with kidney failure.

Peritoneal dialysis (PD)-associated peritonitis is a serious complication of PD and prevention and treatment of such is important in reducing patient morbidity and mortality. The ISPD 2022 updated recommendations have revised and clarified definitions for refractory peritonitis, relapsing peritonitis, peritonitis-associated catheter removal, PD-associated haemodialysis transfer, peritonitis-associated death and peritonitis-associated hospitalisation. New peritonitis categories and outcomes including pre-PD peritonitis, enteric peritonitis, catheter-related peritonitis and medical cure are defined. The new targets recommended for overall peritonitis rate should be no more than 0.40 episodes per year at risk and the percentage of patients free of peritonitis per unit time should be targeted at >80% per year. Revised recommendations regarding management of contamination of PD systems, antibiotic prophylaxis for invasive procedures and PD training and reassessment are included. New recommendations regarding management of modifiable peritonitis risk factors like domestic pets, hypokalaemia and histamine-2 receptor antagonists are highlighted. Updated recommendations regarding empirical antibiotic selection and dosage of antibiotics and also treatment of peritonitis due to specific microorganisms are made with new recommendation regarding adjunctive oral N-acetylcysteine therapy for mitigating aminoglycoside ototoxicity. Areas for future research in prevention and treatment of PD-related peritonitis are suggested.

Introduction: Chronic kidney disease-mineral and bone disorders (CKD-MBD) are prevalent in patients undergoing maintenance dialysis. Yet, there are limited and mixed evidence on the effects of different dialysis modalities involving longer treatment times or higher frequencies on CKD-MBD markers. Methods: This cohort study used data from 132,523 incident dialysis patients treated with any of the following modalities: conventional thrice-weekly in-center hemodialysis, nocturnal in-center hemodialysis (NICHD), home hemodialysis (HHD), or peritoneal dialysis (PD) from 2007 to 2011. We used marginal structural models fitted with inverse probability weights to adjust for fixed and time-varying confounding and informative censoring. We estimated the average effects of treatments with different dialysis modalities on time-varying serum concentrations of CKD-MBD markers: albumin-corrected calcium, phosphate, parathyroid hormone (PTH), and alkaline phosphatase (ALP) using pooled linear regression. Results: Most of the cohort were exclusively treated with conventional in-center hemodialysis, while few were ever treated with NICHD or HHD. At the baseline, PD patients had the lowest mean and median values of PTH, while NICHD patients had the highest median values. During follow-up, compared to hemodialysis patients, patients treated with NICHD had lower mean serum PTH (19.8 pg/mL [95% confidence interval: 2.8, 36.8] lower), whereas PD and HHD patients had higher mean PTH (39.7 pg/mL [31.6, 47.8] and 51.2 pg/mL [33.0, 69.3] higher, respectively). Compared to hemodialysis patients, phosphate levels were lower for patients treated with NICHD (0.44 mg/dL [0.37, 0.52] lower), PD (0.15 mg/dL [0.12, 0.19] lower), or HHD (0.33 mg/dL [0.27, 0.40] lower). There were no clinically meaningful associations between dialysis modalities and concentrations of calcium or ALP. Conclusion: In incident dialysis patients, compared to treatment with conventional in-center hemodialysis, treatments with other dialysis modalities with longer treatment times or higher frequency were associated with different patterns of serum phosphate and PTH. Given the recent growth in the use of dialysis modalities other than hemodialysis, the associations between the treatment and the CKD-MBD markers warrant additional study.

Background and aims Creatinine-based MDRD and CKD-EPI equations include a race correction factor, which results in higher eGFR in Black patients. We evaluated the impact on our patient population upon adoption of the CKD-EPI equation and the removal of the race correction factor from the equation. Materials and methods Retrospective analysis of blood creatinine results and respective eGFR values calculated by the MDRD or CKD-EPI equation without the race correction factor (CKD-EPINoRace) in a large academic medical system over a 20.5-month period. Results In our population, when changing from MDRD to CKD-EPINoRace, we observed that 3.5% of all patients were reclassified to categorically have worse kidney function. However, we also observed fewer patients overall with eGFR below 60 mL/min/1.73 m2. Around 60 and 20 mL/min/1.73 m2, 2.96% and 0.16% of all patients > 65 years of age were reclassified, as were 4.29% and 0.03% of all Black patients, respectively. When calculated with CKD-EPINoRace, median eGFR was not meaningfully different between Black and non-Black patients (p = 0.02). Conclusions Changing from MDRD to CKD-EPINoRace could lead to a lower referral rate to nephrology. The distributions of creatinine and eGFR calculated with CKD-EPINoRace were not meaningfully different in Black and non-Black patients.

ImportanceOn September 20, 2017, one of the most destructive hurricanes in US history made landfall in Puerto Rico. Anecdotal reports suggest that many persons with kidney failure left Puerto Rico after Hurricane Maria; however, empirical estimates of migration and health outcomes for this population are scarce.ObjectiveTo assess the changes in migration and mortality among patients with kidney failure in need of dialysis treatment in Puerto Rico after Hurricane Maria.Design, Setting, and ParticipantsThis cross-sectional study used an interrupted time-series design of 6-month mortality rates and migration of 11 652 patients who received hemodialysis or peritoneal dialysis care in Puerto Rico before Hurricane Maria (before October 1, 2017) and/or during and after Hurricane Maria (on/after October 1, 2017). Data analyses were performed from February 12, 2019, to June 16, 2022..Main Outcomes and MeasuresNumber of unique persons dialyzed in Puerto Rico per quarter; receipt of dialysis treatment outside Puerto Rico per quarter; and 6-month mortality rate per person-quarter for all persons undergoing dialysis.ExposuresHurricane Maria.ResultsThe entire study sample comprised 11 652 unique persons (mean [SD] age, 59 [14.7] years; 7157 [61.6%] men and 4465 [38.4%] women; 10 675 [91.9%] Hispanic individuals). There were 9022 patients with kidney failure and dialysis treatment before and 5397 patients after Hurricane Maria. Before the hurricane, the mean quarterly number of unique persons dialyzed in Puerto Rico was 2834 per quarter (95% CI, 2771-2897); afterwards it dropped to 261 (95% CI, −348 to −175; relative change, 9.2%). The percentage of persons who had 1 or more dialysis sessions outside of Puerto Rico in the next quarter following a previous dialysis in Puerto Rico was 7.1% before Hurricane Maria (95% CI, 4.8 to 9.3). There was a significant increase of 5.8 percentage points immediately after the hurricane (95% CI, 2.7 to 9.0). The 6-month mortality rate per person-quarter was 0.08 (95% CI, 0.08 to 0.09), and there was a nonsignificant increase in level of mortality rates and a nonsignificant decreasing trend in mortality rates.Conclusions and RelevanceThe findings of this cross-sectional study suggest there was a significant increase in the number of people receiving dialysis outside of Puerto Rico after Hurricane Maria. However, no significant differences in mortality rates before and after the hurricane were found, which may reflect disaster emergency preparedness among dialysis facilities and the population with kidney failure, as well as efforts from other stakeholders.

Background and objectives The population of patients with kidney failure in the United States using home dialysis modalities is growing rapidly. Unlike for in-center hemodialysis, there is no patient-reported experience measure for assessment of patient experience of care for peritoneal dialysis or home hemodialysis. We sought to develop and establish content validity of a patient-reported experience measure for patients undergoing home dialysis using a mixed methods multiple stakeholder approach. Design, setting, participants, & measurements We conducted a structured literature review, followed by concept elicitation focus groups and interviews among 65 participants, including 21 patients on home dialysis, 33 home dialysis nurses, three patient care partners, and eight nephrologists. We generated a list of candidate items for possible measure inclusion and conducted a national prioritization exercise among 91 patients on home dialysis and 39 providers using a web-based platform. We drafted the Home Dialysis Care Experience instrument and conducted cognitive debriefing interviews to evaluate item interpretability, order, and structure. We iteratively refined the measure on the basis of interview findings. Results The literature review and concept elicitation phases supported 15 domains of home dialysis care experience in six areas: communication and education of patients, concern and helpfulness of the care team, proficiency of the care team, patient-centered care, care coordination, and amenities and environment. Focus groups results showed that domains of highest importance for measure inclusion were patient education and communication, care coordination, and personalization of care. Prioritization exercise results confirmed focus group findings. Cognitive debriefing indicated that the final measure was easily understood and supported content validity. Conclusions The Home Dialysis Care Experience instrument is a 26-item patient-reported experience measure for use in peritoneal dialysis and home hemodialysis. The Home Dialysis Care Experience instrument represents the first rigorously developed and content-valid English-language instrument for assessment of patient-reported experience of care in home dialysis.

ImportanceBefore 2021, most Medicare beneficiaries with end-stage renal disease (ESRD) were unable to enroll in private Medicare Advantage (MA) plans. The 21st Century Cures Act permitted these beneficiaries to enroll in MA plans effective January 2021.ObjectiveTo examine changes in MA enrollment among Medicare beneficiaries with ESRD after enactment of the 21st Century Cures Act overall and by race or ethnicity and dual-eligible status.Design, Setting, and ParticipantsThis cross-sectional time-trend study used data from Medicare beneficiaries with ESRD (both kidney transplant recipients and those undergoing dialysis) between January 2019 and December 2021. Data were analyzed between June and October 2022.Exposures21st Century Cures Act.Main Outcomes and MeasuresPrimary outcomes were the proportion of Medicare beneficiaries with prevalent ESRD who switched from traditional Medicare to MA between 2020 and 2021 and those with incident ESRD who newly enrolled in MA in 2021. Individuals who stayed in traditional Medicare were enrolled in 2020 and 2021 and those who switched to MA were enrolled in traditional Medicare in 2020 and MA in 2021.ResultsAmong 575 797 beneficiaries with ESRD in 2020 or 2021 (mean [SD] age, 64.7 [14.2] years, 42.2% female, 34.0% Black, and 7.7% Hispanic or Latino), the proportion of beneficiaries enrolled in MA increased from 24.8% (December 2020) to 37.4% (December 2021), a relative change of 50.8%. The largest relative increases in MA enrollment were among Black (72.8% relative increase), Hispanic (44.8%), and dual-eligible beneficiaries with ESRD (73.6%). Among 359 617 beneficiaries with TM and prevalent ESRD in 2020, 17.6% switched to MA in 2021. Compared with individuals who stayed in traditional Medicare, those who switched to MA had modestly more chronic conditions (6.3 vs 6.1; difference, 0.12 conditions [95% CI, 0.10-0.16]) and similar nondrug spending in 2020 (difference, $509 [95% CI, −$58 to $1075]) but were more likely to be Black (difference, 19.5 percentage points [95% CI, 19.1-19.9]) and have dual Medicare-Medicaid eligibility (difference, 20.8 percentage points [95% CI, 20.4-21.2]). Among beneficiaries who were newly eligible for Medicare ESRD benefits in 2021, 35.2% enrolled in MA.Conclusions and RelevanceResults suggest that increases in MA enrollment among Medicare beneficiaries with ESRD were substantial the first year after the 21st Century Cures Act, particularly among Black, Hispanic, and dual-eligible individuals. Policy makers and MA plans may need to assess network adequacy, disenrollment, and equity of care for beneficiaries who enrolled in MA.

Lay summary Peritoneal dialysis (PD) uses the peritoneal membrane for dialysis. The peritoneal membrane is a thin layer of tissue that lines the abdomen. The lining is used as a filter to help remove extra fluid and poisonous waste from the blood. Everybody is unique. What is normal for one person’s membrane may be very different from another person’s. The kidney care team wants to provide each person with the best dialysis prescription for them and to do this they must evaluate the person’s peritoneal lining. Sometimes dialysis treatment itself can cause the membrane to change after some years. This means more assessments (evaluations) will be needed to determine whether the person’s peritoneal membrane has changed. Changes in the membrane may require changes to the dialysis prescription. This is needed to achieve the best dialysis outcomes. A key tool for these assessments is the peritoneal equilibration test (PET). It is a simple, standardized and reproducible tool. This tool is used to measure the peritoneal function soon after the start of dialysis. The goal is to understand how well the peritoneal membrane works at the start of dialysis. Later on in treatment, the PET helps to monitor changes in peritoneal function. If there are changes between assessments causing problems, the PET data may explain the cause of the dysfunction. This may be used to change the dialysis prescription to achieve the best outcomes. The most common problem with the peritoneal membrane occurs when fluid is not removed as well as it should be. This happens when toxins (poisons) in the blood cross the membrane more quickly than they should. This is referred to as a fast peritoneal solute transfer rate (PSTR). Since more efficient fluid removal is associated with better outcomes, developing a personal PD prescription based on the person’s PSTR is critically important. A less common problem happens when the membrane fails to work properly (also called membrane dysfunction) because the peritoneal membrane is less efficient, either at the start of treatment or developing after some years. If membrane dysfunction gets worse over time, then this is associated with progressive damage, scarring and thickening of the membrane. This problem can be identified through another change of the PET. It is called reduced ‘sodium dip’. Membrane dysfunction of this type is more difficult to treat and has many implications for the individual. If the damage is major, the person may need to stop PD. They would need to begin haemodialysis treatment (also spelled hemodialysis). This is a very important and emotional decision for individuals with kidney failure. Any decision that involves stopping PD therapy or transitioning to haemodialysis therapy should be made jointly between the clinical team, the person on dialysis and a caregiver, if requested. Although evidence is lacking about how often tests should be performed to determine peritoneal function, it seems reasonable to repeat them whenever there is difficulty in removing the amount of fluid necessary for maintaining the health and well-being of the individual. Whether routine evaluation of membrane function is associated with better outcomes has not been studied. Further research is needed to answer this important question as national policies in many parts of the world and the COVID-19 has placed a greater emphasis and new incentives encouraging the greater adoption of home dialysis therapies, especially PD. For Chinese and Spanish Translation of the Lay Summary, see Online Supplement Appendix 1. Key recommendations Guideline 1: A pathophysiological taxonomy: A pathophysiological classification of membrane dysfunction, which provides mechanistic links to functional characteristics, should be used when prescribing individualized dialysis or when planning modality transfer (e.g. to automated peritoneal dialysis (PD) or haemodialysis) in the context of shared and informed decision-making with the person on PD, taking individual circumstances and treatment goals into account. (practice point) Guideline 2a: Identification of fast peritoneal solute transfer rate (PSTR): It is recommended that the PSTR is determined from a 4-h peritoneal equilibration test (PET), using either 2.5%/2.27% or 4.25%/3.86% dextrose/glucose concentration and creatinine as the index solute. (practice point) This should be done early in the course dialysis treatment (between 6 weeks and 12 weeks) (GRADE 1A) and subsequently when clinically indicated. (practice point) Guideline 2b: Clinical implications and mitigation of fast solute transfer: A faster PSTR is associated with lower survival on PD. (GRADE 1A) This risk is in part due to the lower ultrafiltration (UF) and increased net fluid reabsorption that occurs when the PSTR is above the average value. The resulting lower net UF can be avoided by shortening glucose-based exchanges, using a polyglucose solution (icodextrin), and/or prescribing higher glucose concentrations. (GRADE 1A) Compared to glucose, use of icodextrin can translate into improved fluid status and fewer episodes of fluid overload. (GRADE 1A) Use of automated PD and icodextrin may mitigate the mortality risk associated with fast PSTR. (practice point) Guideline 3: Recognizing low UF capacity: This is easy to measure and a valuable screening test. Insufficient UF should be suspected when either (a) the net UF from a 4-h PET is Guideline 4a: Diagnosing intrinsic membrane dysfunction (manifesting as low osmotic conductance to glucose) as a cause of UF insufficiency: When insufficient UF is suspected, the 4-h PET should be supplemented by measurement of the sodium dip at 1 h using a 3.86% glucose/4.25% dextrose exchange for diagnostic purposes. A sodium dip ≤5 mmol/L and/or a sodium sieving ratio ≤0.03 at 1 h indicates UF insufficiency. (GRADE 2B) Guideline 4b: Clinical implications of intrinsic membrane dysfunction (de novo or acquired): in the absence of residual kidney function, this is likely to necessitate the use of hypertonic glucose exchanges and possible transfer to haemodialysis. Acquired membrane injury, especially in the context of prolonged time on treatment, should prompt discussions about the risk of encapsulating peritoneal sclerosis. (practice point) Guideline 5: Additional membrane function tests: measures of peritoneal protein loss, intraperitoneal pressure and more complex tests that estimate osmotic conductance and ‘lymphatic’ reabsorption are not recommended for routine clinical practice but remain valuable research methods. (practice point) Guideline 6: Socioeconomic considerations: When resource constraints prevent the use of routine tests, consideration of membrane function should still be part of the clinical management and may be inferred from the daily UF in response to the prescription. (practice point)

The recently published 2020 International Society for Peritoneal Dialysis (ISPD) practice recommendations regarding prescription of high-quality goal-directed peritoneal dialysis differ fundamentally from previous guidelines that focused on "adequacy" of dialysis. The new ISPD publication emphasizes the need for a person-centered approach with shared decision making between the individual performing peritoneal dialysis and the clinical care team while taking a broader view of the various issues faced by that individual. Cognizant of the lack of strong evidence for the recommendations made, they are labeled as "practice points" rather than being graded numerically. This commentary presents the views of a work group convened by the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) to assess these recommendations and assist clinical providers in the United States in interpreting and implementing them. This will require changes to the current clinical paradigm, including greater resource allocation to allow for enhanced services that provide a more holistic and person-centered assessment of the quality of dialysis delivered.

Rationale & objectiveObservational studies have reported a U-shaped association between blood pressure (BP) before a hemodialysis session and death. In contrast, because a linear association between out-of-dialysis-unit BP and death has been reported, home BP may be a better target for treatment. To test the feasibility of this approach, we conducted a pilot trial of treating home versus predialysis BP in hemodialysis patients.Study designA 4-month, parallel, randomized, controlled trial.Settings & participants50 prevalent hemodialysis patients in San Francisco and Seattle. Participants were randomly assigned using 1:1 block randomization, stratified by site.InterventionsTo target home systolic BP (SBP)of 100-200mm Hg; 0.2% vs 0%) or low (defined as

Background Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (PD). Methods We searched the Cochrane Kidney and Transplant Specialized Register for randomized trials in PD. We extracted all reported outcome domains and measurements and analyzed their frequency and characteristics. Results From 128 reports of 120 included trials, 80 different outcome domains were reported. Overall, 39 (49%) domains were surrogate, 23 (29%) patient-reported and 18 (22%) clinical. The five most commonly reported domains were PD-related infection [59 (49%) trials], dialysis solute clearance [51 (42%)], kidney function [45 (38%)], protein metabolism [44 (37%)] and inflammatory markers/oxidative stress [42 (35%)]. Quality of life was reported infrequently (4% of trials). Only 14 (12%) trials included a patient-reported outcome as a primary outcome. The median number of outcome measures (defined as a different measurement, aggregation and metric) was 22 (interquartile range 13–37) per trial. PD-related infection was the most frequently reported clinical outcome as well as the most frequently stated primary outcome. A total of 383 different measures for infection were used, with 66 used more than once. Conclusions Trials in PD include important clinical outcomes such as infection, but these are measured and reported inconsistently. Patient-reported outcomes are infrequently reported and nearly half of the domains were surrogate. Standardized outcomes for PD trials are required to improve efficiency and relevance.

Trials in children with chronic kidney disease do not consistently report outcomes that are critically important to patients and caregivers. This can diminish the relevance and reliability of evidence for decision making, limiting the implementation of results into practice and policy. As part of the Standardized Outcomes in Nephrology—Children and Adolescents (SONG-Kids) initiative, we convened 2 consensus workshops in San Diego, California (7 patients, 24 caregivers, 43 health professionals) and Melbourne, Australia (7 patients, 23 caregivers, 49 health professionals). This report summarizes the discussions on the identification and implementation of the SONG-Kids core outcomes set. Four themes were identified; survival and life participation are common high priority goals, capturing the whole child and family, ensuring broad relevance across the patient journey, and requiring feasible and valid measures. Stakeholders supported the inclusion of mortality, infection, life participation, and kidney function as the core outcomes domains for children with chronic kidney disease.

The development of dialysis by early pioneers such as Willem Kolff and Belding Scribner set in motion several dramatic changes in the epidemiology, economics and ethical frameworks for the treatment of kidney failure. However, despite a rapid expansion in the provision of dialysis — particularly haemodialysis and most notably in high-income countries (HICs) — the rate of true patient-centred innovation has slowed. Current trends are particularly concerning from a global perspective: current costs are not sustainable, even for HICs, and globally, most people who develop kidney failure forego treatment, resulting in millions of deaths every year. Thus, there is an urgent need to develop new approaches and dialysis modalities that are cost-effective, accessible and offer improved patient outcomes. Nephrology researchers are increasingly engaging with patients to determine their priorities for meaningful outcomes that should be used to measure progress. The overarching message from this engagement is that while patients value longevity, reducing symptom burden and achieving maximal functional and social rehabilitation are prioritized more highly. In response, patients, payors, regulators and health-care systems are increasingly demanding improved value, which can only come about through true patient-centred innovation that supports high-quality, high-value care. Substantial efforts are now underway to support requisite transformative changes. These efforts need to be catalysed, promoted and fostered through international collaboration and harmonization., Dialysis is a life-saving therapy; however, costs of dialysis are high, access is inequitable and outcomes are inadequate. This Review describes the current landscape of dialysis therapy from an epidemiological, economic, ethical and patient-centred framework, and describes initiatives that are aimed at stimulating innovations in the field to one that supports high-quality, high-value care., Key points The global dialysis population is growing rapidly, especially in low-income and middle-income countries; however, worldwide, a substantial number of people lack access to kidney replacement therapy, and millions of people die of kidney failure each year, often without supportive care.The costs of dialysis care are high and will likely continue to rise as a result of increased life expectancy and improved therapies for causes of kidney failure such as diabetes mellitus and cardiovascular disease.Patients on dialysis continue to bear a high burden of disease, shortened life expectancy and report a high symptom burden and a low health-related quality of life.Patient-focused research has identified fatigue, insomnia, cramps, depression, anxiety and frustration as key symptoms contributing to unsatisfactory outcomes for patients on dialysis.Initiatives to transform dialysis outcomes for patients require both top-down efforts (that is, efforts that promote incentives based on systems level policy, regulations, macroeconomic and organizational changes) and bottom-up efforts (that is, patient-led and patient-centred advocacy efforts as well as efforts led by individual teams of innovators).Patients, payors, regulators and health-care systems increasingly demand improved value in dialysis care, which can only come about through true patient-centred innovation that supports high-quality, high-value care.

The worldwide burden of kidney disease is rising, but public awareness remains limited, underscoring the need for more effective communication by stakeholders in the kidney health community. Despite this need for clarity, the nomenclature for describing kidney function and disease lacks uniformity. In June 2019, Kidney Disease: Improving Global Outcomes (KDIGO) convened a Consensus Conference with the goal of standardizing and refining the nomenclature used in the English language to describe kidney function and disease, and of developing a glossary that could be used in scientific publications. Guiding principles of the conference were that the revised nomenclature should be patient-centered, precise, and consistent with nomenclature used in the KDIGO guidelines. Conference attendees reached general consensus on the following recommendations: (i) to use "kidney" rather than "renal" or "nephro-" when referring to kidney disease and kidney function; (ii) to use "kidney failure" with appropriate descriptions of presence or absence of symptoms, signs, and treatment, rather than "end-stage kidney disease"; (iii) to use the KDIGO definition and classification of acute kidney diseases and disorders (AKD) and acute kidney injury (AKI), rather than alternative descriptions, to define and classify severity of AKD and AKI; (iv) to use the KDIGO definition and classification of chronic kidney disease (CKD) rather than alternative descriptions to define and classify severity of CKD; and (v) to use specific kidney measures, such as albuminuria or decreased glomerular filtration rate (GFR), rather than "abnormal" or "reduced" kidney function to describe alterations in kidney structure and function. A proposed 5-part glossary contains specific items for which there was general agreement. Conference attendees acknowledged limitations of the recommendations and glossary, but they considered standardization of scientific nomenclature to be essential for improving communication.

International audience; Blood pressure (BP) and volume control are critical components of dialysis care and have substantial impacts on patient symptoms, quality of life, and cardiovascular complications. Yet, developing consensus best practices for BP and volume control have been challenging, given the absence of objective measures of extracellular volume status and the lack of high-quality evidence for many therapeutic interventions. In February of 2019, Kidney Disease: Improving Global Outcomes (KDIGO) held a Controversies Conference titled Blood Pressure and Volume Management in Dialysis to assess the current state of knowledge related to BP and volume management and identify opportunities to improve clinical and patient-reported outcomes among individuals receiving maintenance dialysis. Four major topics were addressed: BP measurement, BP targets, and pharmacologic management of suboptimal BP; dialysis prescriptions as they relate to BP and volume; extracellular volume assessment and management with a focus on technology-based solutions; and volume-related patient symptoms and experiences. The overarching theme resulting from presentations and discussions was that managing BP and volume in dialysis involves weighing multiple clinical factors and risk considerations as well as patient lifestyle and preferences, all within a narrow therapeutic window for avoiding acute or chronic volume-related complications. Striking this challenging balance requires individualizing the dialysis prescription by incorporating comorbid health conditions, treatment hemodynamic patterns, clinical judgment, and patient preferences into decision-making, all within local resource constraints.

International audience; Outcomes reported in randomized controlled trials in peritoneal dialysis (PD) are diverse, are measured inconsistently, and may not be important to patients, families, and clinicians. The Standardized Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD) initiative aims to establish a core outcome set for trials in PD based on the shared priorities of all stakeholders. We convened an international SONG-PD stakeholder consensus workshop in May 2018 in Vancouver, Canada. Nineteen patients/caregivers and 51 health professionals attended. Participants discussed core outcome domains and implementation in trials in PD. Four themes relating to the formation of core outcome domains were identified: life participation as a main goal of PD, impact of fatigue, empowerment for preparation and planning, and separation of contributing factors from core factors. Considerations for implementation were identified: standardizing patient-reported outcomes, requiring a validated and feasible measure, simplicity of binary outcomes, responsiveness to interventions, and using positive terminology. All stakeholders supported inclusion of PD-related infection, cardiovascular disease, mortality, technique survival, and life participation as the core outcome domains for PD.

ImportanceAlthough Medicare provides health insurance coverage for most patients with kidney failure in the US, Medicare beneficiaries who initiate dialysis without supplemental coverage are exposed to substantial out-of-pocket costs. The availability of expanded Medicaid coverage under the Patient Protection and Affordable Care Act (ACA) for adults with kidney failure may improve access to care and reduce Medicare-financed hospitalizations after dialysis initiation.ObjectiveTo examine the implications of the ACA’s Medicaid expansion for Medicare-financed hospitalizations, health insurance coverage, and predialysis nephrology care among Medicare-covered adults aged 19 to 64 years with incident kidney failure in the first year after initiating dialysis.Design, Setting, and ParticipantsThis cross-sectional study used a difference-in-differences approach to assess Medicare-financed hospitalizations among adults aged 19 to 64 years who initiated dialysis between January 1, 2010, and December 31, 2018, while covered by Medicare Part A (up to 5 years postexpansion). Data on patients were obtained from the Renal Management Information System’s End Stage Renal Disease Medical Evidence Report, which includes data for all patients initiating outpatient maintenance dialysis regardless of health insurance coverage, treatment modality, or citizenship status, and these data were linked with claims data from the Medicare Provider Analysis and Review. Data were analyzed from January to August 2022.ExposureLiving in a Medicaid expansion state.Main Outcomes and MeasuresPrimary outcomes were number of Medicare-financed hospitalizations and hospital days in the first 3 months, 6 months, and 12 months after dialysis initiation. Secondary outcomes included dual Medicare and Medicaid coverage at 91 days after dialysis initiation and the presence of an arteriovenous fistula or graft at dialysis initiation for patients undergoing hemodialysis.ResultsThe study population included 188 671 adults, with 97 071 living in Medicaid expansion states (mean [SD] age, 53.4 [9.4] years; 58 329 men [60.1%]) and 91 600 living in nonexpansion states (mean [SD] age, 53.0 [9.6] years; 52 677 men [57.5%]). In the first 3 months after dialysis initiation, Medicaid expansion was associated with a significant decrease in Medicare-financed hospitalizations (−4.24 [95% CI, −6.70 to −1.78] admissions per 100 patient-years; P = .001) and hospital days (−0.73 [95% CI, −1.08 to −0.39] days per patient-year; P P = .004) increase in dual Medicare and Medicaid coverage at 91 days after dialysis initiation and a 1.65–percentage point (95% CI, 0.31-3.00 percentage points; P = .02) increase in arteriovenous fistula or graft at initiation.Conclusions and RelevanceIn this cross-sectional study with a difference-in-differences analysis, the ACA’s Medicaid expansion was associated with decreases in Medicare-financed hospitalizations and hospital days and increases in dual Medicare and Medicaid coverage. These findings suggest favorable spillover outcomes of Medicaid expansion to Medicare-financed care, which is the primary payer for patients with kidney failure.

International audience; 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.

Infection is a significant driver of morbidity and mortality in patients with end-stage renal disease undergoing maintenance dialysis. In the United States, septicemia and other infections account for 8% deaths in patients undergoing dialysis. In patients undergoing peritoneal dialysis (PD), PD-related peritonitis remains the most frequent treatment-related infection and is the greatest contributor to infection-related morbidity, including risk for hospitalization, and temporary or permanent transfer to hemodialysis. In the 4 decades since the introduction of ambulatory PD in clinical practice, a large number of treatment innovations have been shown to be effective in reducing the risk for exit site infection and PD-related peritonitis. Notwithstanding the evidence for efficacy of these innovations and the numerous adverse health consequences with PD-related peritonitis, the uptake of these interventions in clinical practice around the world remains inconsistent. This article reviews current knowledge with regards to prevention of PD-associated infections, and the diagnosis and management of exit site infections and peritonitis.

International audience; BACKGROUND AND OBJECTIVES: The absence of accepted patient-centered outcomes in research can limit shared decision-making in peritoneal dialysis (PD), particularly because PD-related treatments can be associated with mortality, technique failure, and complications that can impair quality of life. We aimed to identify patient and caregiver priorities for outcomes in PD, and to describe the reasons for their choices. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patients on PD and their caregivers were purposively sampled from nine dialysis units across Australia, the United States, and Hong Kong. Using nominal group technique, participants identified and ranked outcomes, and discussed the reasons for their choices. An importance score (scale 0-1) was calculated for each outcome. Qualitative data were analyzed thematically. RESULTS: Across 14 groups, 126 participants (81 patients, 45 caregivers), aged 18-84 (mean 54, SD 15) years, identified 56 outcomes. The ten highest ranked outcomes were PD infection (importance score, 0.27), mortality (0.25), fatigue (0.25), flexibility with time (0.18), BP (0.17), PD failure (0.16), ability to travel (0.15), sleep (0.14), ability to work (0.14), and effect on family (0.12). Mortality was ranked first in Australia, second in Hong Kong, and 15th in the United States. The five themes were serious and cascading consequences on health, current and impending relevance, maintaining role and social functioning, requiring constant vigilance, and beyond control and responsibility. CONCLUSIONS: For patients on PD and their caregivers, PD-related infection, mortality, and fatigue were of highest priority, and were focused on health, maintaining lifestyle, and self-management. Reporting these patient-centered outcomes may enhance the relevance of research to inform shared decision-making.

Background and Aims Icodextrin is designed to maintain ultrafiltration during the long dwell, especially when there is a risk of increased fluid reabsorption (fast peritoneal solute transfer rate, PSTR), without the need for excessive use of high glucose. Randomized trials have demonstrated these benefits but are insufficiently powered to investigate a clear impact on survival. We aimed to establish international prescription practices and their relationship to clinical outcomes. Method The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is an international prospective cohort study in collaboration with the International Society for Peritoneal Dialysis. The current analysis was drawn from A/NZ, Canada, Japan, UK, and US in PDOPPS phases 1-2 (2014-2019). Patient demographics, comorbidities, lab measurements, clinic blood pressure, membrane function (both solute transport rate and ultrafiltration capacity), dialysis prescription details, urine and 24-hour ultrafiltration volumes were captured at study enrollment. Mortality and permanent transfer to HD (HDT) events were collected during study follow-up [median (IQR) = 1.1 yrs (0.6, 1.7)]. Linear and logistic models were used to analyze the association between icodextrin and blood pressure. Cox regression, stratified by country, was used to analyze the association of icodextrin with time from study enrollment to (a) death and (b) HDT, and adjusted for demographics, 13 comorbidities, transplant waitlisting, serum albumin, urine volume, facility size and % APD use, study phase, while accounting for facility clustering. Results Icodextrin was prescribed in 1,929 (35%) of 5,432 patients studied, but this proportion differed by country, being >44% in all except the US, where it was 17%, and by facility within countries. Patients on icodextrin were more likely to have coronary artery disease and diabetes, have lower residual 24-hour urine volume and function, use less high glucose, have faster PSTR and reduced ultrafiltration capacity, and have been on PD longer (PD vintage: median 1.19, IQR 0.50-2.76). Despite this, patients using icodextrin achieved equivalent ultrafiltration to those using glucose at every level of residual urine volume (see figure). The low use of icodextrin in the US was more than compensated for by much greater use of high glucose and overall higher ultrafiltration volumes at each level of urine volume. Icodextrin use was not associated with blood pressure (effects: 0.90 mmHg, 95% CI: -0.68, 2.47), mortality (Hazard ratio [HR] 1.01, 95% CI: 0.83, 1.23) and HDT (HR 1.05, 95% CI: 0.90, 1.23). Conclusion There are important national and facility differences in the prescription of icodextrin, with the US a clear outlier, with less icodextrin and more high glucose use, resulting in higher ultrafiltration volumes. These practices and the targeting of patients with less efficient membranes for fluid removal may mask any potential survival advantage associated with icodextrin.

The Patient Activation Measure (PAM) is a newly adopted metric by CMS to describe an individual’s knowledge, ability, skills, and confidence in self-managing chronic conditions. The extent to which the PAM is relevant, comprehensive, and associated with clinical, behavioral, and psychosocial outcomes in people with dialysis-dependent kidney failure is, as of yet, unclear. The data we present are the first estimates of association of patient activation with health literacy, mental health, and adherence in patients with dialysis-dependent kidney failure in the United States.

BACKGROUND: The intestinal microbiome is an appealing target for interventions in ESKD because of its likely contribution to uremic toxicity. Before conducting clinical trials of microbiome-altering treatments, it is necessary to understand the within-person and between-person variability in the composition and function of the gut microbiome in patients with ESKD. METHODS: We conducted a multicenter, nonrandomized, crossover feasibility study of patients on maintenance hemodialysis consisting of three phases: pretreatment (8 weeks); treatment, during which the prebiotic, p-inulin, was administered at a dosage of 8 g twice daily (12 weeks); and post-treatment (8 weeks). Stool samples were collected 1–2 times per week and blood was collected weekly for 28 weeks. The gut microbiome was characterized using 16S ribosomal-RNA sequencing and metabolomic profiling. RESULTS: A total of 11 of the 13 participants completed the 28-week study. Interparticipant variability was greater than intraparticipant variability for microbiome composition (P

Movement of solutes across the peritoneum allows for the use of peritoneal dialysis to treat kidney failure. However, there is a large inter-individual variability in the peritoneal solute transfer rate (PSTR). Here, we tested the hypothesis that common genetic variants are associated with variability in PSTR. Of the 3561 participants from 69 centers in six countries, 2850 with complete data were included in a genome-wide association study. PSTR was defined as the four-hour dialysate/plasma creatinine ratio from the first peritoneal equilibration test after starting PD. Heritability of PSTR was estimated using genomic-restricted maximum-likelihood analysis, and the association of PSTR with a genome-wide polygenic risk score was also tested. The mean four-hour dialysate/plasma creatinine ratio in participants was 0.70. In 2212 participants of European ancestry, no signal reached genome-wide significance but 23 single nucleotide variants at four loci demonstrated suggestive associations with PSTR. Meta-analysis of ancestry-stratified regressions in 2850 participants revealed five single-nucleotide variants at four loci with suggestive correlations with PSTR. Association across ancestry strata was consistent for rs28644184 at the KDM2B locus. The estimated heritability of PSTR was 19%, and a permuted model polygenic risk score was significantly associated with PSTR. Thus, this genome-wide association study of patients receiving peritoneal dialysis bolsters evidence for a genetic contribution to inter-individual variability in PSTR.

This chapter provides an overview of the many challenges experienced in trying to conduct psychosocial research in patients with renal disease. In this context, psychosocial research is meant to include both research on treatments for comorbid psychiatric illnesses and behavioral interventions targeting symptoms experienced by patients with advanced renal disease, regardless of the symptoms’ psychiatric or medical etiology. The chapter highlights 10 challenges in conducting these types of research: 1. Buy-in from the nephrology research community 2. Complexity of clinical trials 3. Identifying patients of interest 4. Stigma associated with some psychiatric diagnoses 5. Accessibility of mental health treatments 6. Reluctance regarding medications 7. Significance of outcome measures 8. Lack of validation of PROs 9. Challenges to completion of research assessments 10. Response bias A discussion of each of these challenges is followed by suggestions regarding how to best effectively address, avoid, or mitigate them. While there is extra complexity in designing and executing psychosocial clinical trials in nephrology, the need for high-quality studies is urgent, and the effect of these trials on clinical care can be paradigm shifting.

BACKGROUND: Low-income individuals without health insurance have limited access to health care. Medicaid expansions may reduce kidney failure incidence by improving access to chronic disease care. METHODS: Using a difference-in-differences analysis, we examined the association between Medicaid expansion status under the Affordable Care Act (ACA) and the kidney failure incidence rate among all nonelderly adults, aged 19–64 years, in the United States, from 2012 through 2018. We compared changes in kidney failure incidence in states that implemented Medicaid expansions with concurrent changes in nonexpansion states during pre-expansion, early postexpansion (years 2 and 3 postexpansion), and later postexpansion (years 4 and 5 postexpansion). RESULTS: The unadjusted kidney failure incidence rate increased in the early years of the study period in both expansion and nonexpansion states before stabilizing. After adjustment for population sociodemographic characteristics, Medicaid expansion status was associated with 2.20 fewer incident cases of kidney failure per million adults per quarter in the early postexpansion period (95% CI, −3.89 to −0.51) compared with nonexpansion status, a 3.07% relative reduction (95% CI, −5.43% to −0.72%). In the later postexpansion period, Medicaid expansion status was not associated with a statistically significant change in kidney failure incidence (−0.56 cases per million per quarter; 95% CI, −2.71 to 1.58) compared with nonexpansion status and the pre-expansion time period. CONCLUSIONS: The ACA Medicaid expansion was associated with an initial reduction in kidney failure incidence among the entire, nonelderly, adult population in the United States; but the changes did not persist in the later postexpansion period. Further study is needed to determine the long-term association between Medicaid expansion and changes in kidney failure incidence.

BackgroundPatients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD.MethodsThis trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy.DiscussionThis clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD.Trial registrationNCT03534284May 23, 2018.SLEEP-HD Protocol Version:1.3.4 (7/22/2020).

Background Combination therapy with isosorbide dinitrate (ISD) and hydralazine (HY) reduces heart failure mortality. The safety and tolerability in individuals requiring maintenance hemodialysis (HD) is unknown. Methods Single-center, randomized, placebo-controlled, double-blind pilot trial to explore safety and tolerability of ISD/HY in maintenance HD. Participants were randomized to placebo or combination ISD/HY. Dose was escalated over 3 weeks from ISD 10 mg/HY 10 mg to ISD 40 mg/HY 75 mg three times per day with the maximum tolerated dose maintained for the subsequent 21 weeks. Primary endpoints included adverse events, adverse events precluding further treatment with study medication, serious hypotension (i.e., requiring hospitalization or emergency room visit), and recurrent intra-dialytic hypotension. Efficacy signals included change in mitral annular E’ velocity by tissue Doppler echocardiography and change in left ventricular coronary flow reserve on positron emission tomography. Results A total of 17 individuals were randomized to ISD/HY (N=7) or placebo (N=10). All participants assigned to ISD/HY completed dose escalation to 40/75 mg, but dose reductions were required in two participants. No participants discontinued therapy. There were no serious hypotension events. Recurrent intradialytic hypotension was less frequent with ISD/HY (0.47 events/patient-year) than placebo (1.83 events/patient-year, P=0.04). In contrast, nausea (ISD/HY, 1.90 events/patient-year; placebo, 0.50 events/patient-year, P=0.03) was significantly more frequent, and headache and diarrhea were numerically but not significantly more frequent with ISD/HY. Adverse events were more frequent with ISD/HY (11.4 events/patient-year) than placebo (6.31 events/patient-year). We did not detect between-group differences in the change in E’ (P=0.34); ISD/HY showed a mean increase of 0.6 cm/s (SD 1.1), and placebo showed a mean decrease of 0.04 cm/s (SD 0.9). Changes in coronary flow reserve were minimal, −0.3 (0.2) with ISD/HY and −0.03 (0.5) in the placebo group, P=0.19. Conclusions ISD/HY appears to be well tolerated in patients being treated with maintenance HD, but headache and gastrointestinal side effects occur more frequently with ISD/HY compared with placebo.

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.