Preparing for the unexpected: Recommendations for returning secondary findings in late-stage cancer care.

PURPOSE: We conducted qualitative interviews with patients with cancer and providers to identify gaps in clinical care and highlight care delivery solutions for the return of secondary germline findings. METHODS: Twelve patients and 19 cancer providers from the United States were interviewed between January 2019 and May 2021. Interviews elicited feedback about patient information needs, emotional responses to secondary findings, and recommendations for improving pre-test education. RESULTS: Patients' responses ranged from gratitude to regret, depending on how much pre-test counseling they received before tumor testing. Providers cited insufficient clinic time as a major barrier to pretest education, favoring online support tools and standardized pre-test education models. Providers had differing perspectives on how pre-test education should be integrated into clinical workflows but agreed that it should include the differences between somatic and germline testing, the likelihood of medically actionable findings, and the possibility of being referred to a genetics provider. CONCLUSION: The spectrum of participants' responses to their secondary findings underscores the importance of adequate pre-test discussions before somatic sequencing. Although educational interventions could address patients' information needs and augment traditional pre-test counseling, health care systems, labs, and genetic providers may be called on to play greater roles in pre-test education.

Barriers to home dialysis and kidney transplantation for socially disadvantaged individuals.

PURPOSE OF REVIEW: People with kidney disease facing social disadvantage have multiple barriers to quality kidney care. The aim of this review is to summarize the patient, clinician, and system wide factors that impact access to quality kidney care and discuss potential solutions to improve outcomes for socially disadvantaged people with kidney disease. RECENT FINDINGS: Patient level factors such as poverty, insurance, and employment affect access to care, and low health literacy and kidney disease awareness can affect engagement with care. Clinician level factors include lack of early nephrology referral, limited education of clinicians in home dialysis and transplantation, and poor patient-physician communication. System-level factors such as lack of predialysis care and adequate health insurance can affect timely access to care. Neighborhood level socioeconomic factors, and lack of inclusion of these factors into public policy payment models, can affect ability to access care. Moreover, the effects of structural racism and discrimination nay negatively affect the kidney care experience for racially and ethnically minoritized individuals. SUMMARY: Patient, clinician, and system level factors affect access to and engagement in quality kidney care. Multilevel solutions are critical to achieving equitable care for all affected by kidney disease.

Impact of Prior Abdominal Procedures on Peritoneal Dialysis Catheter Outcomes: Findings From the North American Peritoneal Dialysis Catheter Registry.

RATIONALE & OBJECTIVE: A history of prior abdominal procedures may influence the likelihood of referral for peritoneal dialysis (PD) catheter insertion. To guide clinical decision making in this population, this study examined the association between prior abdominal procedures and outcomes in patients undergoing PD catheter insertion. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Adults undergoing their first PD catheter insertion between November 1, 2011, and November 1, 2020, at 11 institutions in Canada and the United States participating in the International Society for Peritoneal Dialysis North American Catheter Registry. EXPOSURE: Prior abdominal procedure(s) defined as any procedure that enters the peritoneal cavity. OUTCOMES: The primary outcome was time to the first of (1) abandonment of the PD catheter or (2) interruption/termination of PD. Secondary outcomes were rates of emergency room visits, hospitalizations, and procedures. ANALYTICAL APPROACH: Cumulative incidence curves were used to describe the risk over time, and an adjusted Cox proportional hazards model was used to estimate the association between the exposure and primary outcome. Models for count data were used to estimate the associations between the exposure and secondary outcomes. RESULTS: Of 855 patients who met the inclusion criteria, 31% had a history of a prior abdominal procedure and 20% experienced at least 1 PD catheter-related complication that led to the primary outcome. Prior abdominal procedures were not associated with an increased risk of the primary outcome (adjusted HR, 1.12; 95% CI, 0.68-1.84). Upper-abdominal procedures were associated with a higher adjusted hazard of the primary outcome, but there was no dose-response relationship concerning the number of procedures. There was no association between prior abdominal procedures and other secondary outcomes. LIMITATIONS: Observational study and cohort limited to a sample of patients believed to be potential candidates for PD catheter insertion. CONCLUSION: A history of prior abdominal procedure(s) does not appear to influence catheter outcomes following PD catheter insertion. Such a history should not be a contraindication to PD. PLAIN-LANGUAGE SUMMARY: Peritoneal dialysis (PD) is a life-saving therapy for individuals with kidney failure that can be done at home. PD requires the placement of a tube, or catheter, into the abdomen to allow the exchange of dialysis fluid during treatment. There is concern that individuals who have undergone prior abdominal procedures and are referred for a catheter might have scarring that could affect catheter function. In some institutions, they might not even be offered PD therapy as an option. In this study, we found that a history of prior abdominal procedures did not increase the risk of PD catheter complications and should not dissuade patients from choosing PD or providers from recommending it.

Differences in Outcomes by Place of Origin among Hispanic Patients with Kidney Failure.

SIGNIFICANCE STATEMENT: Hispanic patients are known to have a higher risk of kidney failure and lower rates of home dialysis use and kidney transplantation than non-Hispanic White patients. However, it is unknown whether these outcomes differ within the Hispanic community, which is heterogeneous in its members' places of origins. Using United States Renal Data System data, the authors found similar adjusted rates of home dialysis use for patients originating from places outside the United States and US-born Hispanic patients, whereas the adjusted risk of mortality and likelihood of transplantation differed depending on place (country or territory) of origin. Understanding the heterogeneity in kidney disease outcomes and treatment within the Hispanic community is crucial in designing interventions and implementation strategies to ensure that Hispanic individuals with kidney failure have equitable access to care. BACKGROUND: Compared with non-Hispanic White groups, Hispanic individuals have a higher risk of kidney failure yet lower rates of living donor transplantation and home dialysis. However, how home dialysis, mortality, and transplantation vary within the Hispanic community depending on patients' place of origin is unclear. METHODS: We identified adult Hispanic patients from the United States Renal Data System who initiated dialysis in 2009-2017. Primary exposure was country or territory of origin (the United States, Mexico, US-Puerto Rico, and other countries). We used logistic regression to estimate differences in odds of initiating home dialysis and competing risk models to estimate subdistribution hazard ratios (SHR) of mortality and kidney transplantation. RESULTS: Of 137,039 patients, 44.4% were US-born, 30.9% were from Mexico, 12.9% were from US-Puerto Rico, and 11.8% were from other countries. Home dialysis rates were higher among US-born patients, but not significantly different after adjusting for demographic, medical, socioeconomic, and facility-level factors. Adjusted mortality risk was higher for individuals from US-Puerto Rico (SHR, 1.04; 95% confidence interval [CI], 1.01 to 1.08) and lower for Mexico (SHR, 0.80; 95% CI, 0.78 to 0.81) and other countries (SHR, 0.83; 95% CI, 0.81 to 0.86) compared with US-born patients. The adjusted rate of transplantation for Mexican or US-Puerto Rican patients was similar to that of US-born patients but higher for those from other countries (SHR, 1.22; 95% CI, 1.15 to 1.30). CONCLUSIONS: Hispanic people from different places of origin have similar adjusted rates of home dialysis but different adjusted rates of mortality and kidney transplantation. Further research is needed to understand the mechanisms underlying these observed differences in outcomes.

Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology.

ABSTRACT: Latinx populations face a higher burden of kidney failure and associated negative outcomes compared with non-Latinx White populations, despite sharing a similar prevalence of CKD. Community health worker (CHW) interventions have been shown to improve outcomes for Latinx individuals, but they are largely underutilized in kidney disease. We convened a workshop of four ongoing kidney disease CHW programs to identify successes, challenges, potential solutions, and needed research to promote CHW programs for Latinx individuals with kidney disease. Key points from the workshop and recommendations for intervention and research are highlighted. Facilitators of program success included prioritizing trust-building with participants, enabling participants to determine what aspects of the intervention were needed, providing participants with tools to help themselves and others after the intervention, and taking a trauma-informed approach to relationships. Challenges included persistent systemic barriers despite successful care navigation and low recruitment and retention. Research is needed to capture the effect of CHW interventions on outcomes and to determine how to implement CHW interventions for people with kidney disease nationwide.

Peritoneal Dialysis-Associated Peritonitis Trends Using Medicare Claims Data, 2013-2017.

RATIONALE & OBJECTIVE: The occurrence and consequences of peritoneal dialysis (PD)-associated peritonitis limit its use in populations with kidney failure. Studies of large clinical populations may enhance our understanding of peritonitis. To facilitate these studies we developed an approach to measuring peritonitis rates using Medicare claims data to characterize peritonitis trends and identify its clinical risk factors. STUDY DESIGN: Retrospective cohort study of PD-associated peritonitis. SETTING & PARTICIPANTS: US Renal Data System standard analysis files were used for claims, eligibility, modality, and demographic information. The sample consisted of patients receiving PD treated at some time between 2013 and 2017 who were covered by Medicare fee-for-service (FFS) insurance with paid claims for dialysis or hospital services. EXPOSURES/PREDICTORS: Peritonitis risk was characterized by year, age, sex, race, ethnicity, vintage of kidney replacement therapy, cause of kidney failure, and prior peritonitis episodes. OUTCOME: The major outcome was peritonitis, identified using ICD-9 and ICD-10 diagnosis codes. Closely spaced peritonitis claims (30 days) were aggregated into 1 peritonitis episode. ANALYTICAL APPROACH: Patient-level risk factors for peritonitis were modeled using Poisson regression. RESULTS: We identified 70,271 peritonitis episodes from 396,289 peritonitis claims. Although various codes were used to record an episode of peritonitis, none was used predominantly. Peritonitis episodes were often identified by multiple aggregated claims, with the mean and median claims per episode being 5.6 and 2, respectively. We found 40% of episodes were exclusively outpatient, 9% exclusively inpatient, and 16% were exclusively based on codes that do not clearly distinguish peritonitis from catheter infections/inflammation ("catheter codes"). The overall peritonitis rate was 0.54 episodes per patient-year (EPPY). The rate was 0.45 EPPY after excluding catheter codes and 0.35 EPPY when limited to episodes that only included claims from nephrologists or dialysis providers. The peritonitis rate declined by 5%/year and varied by patient factors including age (lower rates at higher ages), race (Black > White>Asian), and prior peritonitis episodes (higher rate with each prior episode). LIMITATIONS: Coding heterogeneity indicates a lack of standardization. Episodes based exclusively on catheter codes could represent false positives. Peritonitis episodes were not validated against symptoms or microbiologic data. CONCLUSIONS: PD-associated peritonitis rates decline over time and were lower among older patients. A claims-based approach offers a promising framework for the study of PD-associated peritonitis.

Estimation and evaluation of individualized treatment rules following multiple imputation.

An individualized treatment rule (ITR) is a function that inputs patient-level information and outputs a recommended treatment. An important focus of precision medicine is to develop optimal ITRs that maximize a population-level distributional summary. However, guidance for estimating and evaluating optimal ITRs in the presence of missing data is limited. Our work is motivated by the Social Incentives to Encourage Physical Activity and Understand Predictors (STEP UP) study. Participants were randomized to a control or one of three interventions designed to increase physical activity and were given wearable devices to record daily steps as a measure of physical activity. Many participants were missing at least one daily step count during the study period. In the primary analysis of the STEP UP trial, multiple imputation (MI) was used to address missingness in daily step counts. Despite ubiquitous use of MI in practice, it has been given relatively little attention in the context of personalized medicine. We fill this gap by describing two frameworks for estimation and evaluation of an optimal ITR following MI and assessing their performance using simulated data. One framework relies on splitting the data into independent training and testing sets for estimation and evaluation, respectively. The other framework estimates an optimal ITR using the full data and constructs an m $$ m $$ -out-of- n $$ n $$ bootstrap confidence interval to evaluate its performance. Finally, we provide an illustrative analysis to estimate and evaluate an optimal ITR from the STEP UP data with a focus on practical considerations such as choosing the number of imputations.

Ecological-Systems Contributors to Internalizing Symptoms in a US Sample of Adolescents During the COVID-19 Pandemic.

OBJECTIVE: Internalizing problems are common in adolescence and increased substantially during the COVID-19 pandemic. Although rates of anxiety and depression have since improved, the general increase in the prevalence of mental health problems and disruptions to mental health services during the COVID-19 pandemic has resulted in huge gaps in care. Although research has primarily focused on proximal correlates of internalizing problems, a growing literature suggests that factors outside youths' immediate microsystems are equally crucial for their mental well-being. Thus, it is important to investigate multisystemic correlates of internalizing problems to inform individual and community-based interventions to address the current mental health burden. METHOD: Leveraging secondary data from a nationally diverse U.S. sample of 2,954 adolescents (ages 13-16), we examined the associations between factors at multiple levels of youths' ecologies - spanning indicators of threat and deprivation - and their depression and anxiety symptoms during the COVID-19 pandemic. Furthermore, in follow-up exploratory analyses, we examined if these associations differed by adolescents' racial/ethnic groups. RESULTS: Consistent with socioecological models, we found that indicators of threat and deprivation in the adolescents' immediate home and more distal neighborhood environments were associated with depression and anxiety symptoms. The patterns of associations were similar across racial/ethnic groups in multigroup structural equation models. Additionally, we found that mean levels of internalizing symptoms and socioecological predictors significantly differed across racial/ethnic groups. CONCLUSION: These findings have important implications for understanding multi-level contributors to adolescent mental health, which may inform research, practice, and policy.

Cost Barriers to More Widespread Use of Peritoneal Dialysis in the United States.

The United States Department of Health and Human Services launched the Advancing American Kidney Health Initiative in 2019, which included a goal of transforming dialysis care from an in-center to a largely home-based dialysis program. A substantial motivator for this transition is the potential to reduce costs of ESKD care with peritoneal dialysis. Studies demonstrating that peritoneal dialysis is less costly than in-center hemodialysis have often focused on the perspective of the payer, whereas less consideration has been given to the costs of those who are more directly involved in treatment decision making, including patients, caregivers, physicians, and dialysis facilities. We review comparisons of peritoneal dialysis and in-center hemodialysis costs, focusing on costs incurred by the people and organizations making decisions about dialysis modality, to highlight the financial barriers toward increased adoption of peritoneal dialysis. We specifically address misaligned economic incentives, underappreciated costs for key stakeholders involved in peritoneal dialysis delivery, differences in provider costs, and transition costs. We conclude by offering policy suggestions that include improving data collection to better understand costs in peritoneal dialysis, and sharing potential savings among all stakeholders, to incentivize a transition to peritoneal dialysis.

Implementation considerations of deprescribing interventions: A scoping review.

Over half of older adults experience polypharmacy, including medications that may be inappropriate or unnecessary. Deprescribing, which is the process of discontinuing or reducing inappropriate and/or unnecessary medications, is an effective way to reduce polypharmacy. This review summarizes (1) the process of deprescribing and conceptual models and tools that have been developed to facilitate deprescribing, (2) barriers, enablers, and factors associated with deprescribing, and (3) characteristics of deprescribing interventions in completed trials, as well as (4) implementation considerations for deprescribing in routine practice. In conceptual models of deprescribing, multilevel factors of the patient, clinician, and health-care system are all related to the efficacy of deprescribing. Numerous tools have been developed for clinicians to facilitate deprescribing, yet most require substantial time and, thus, may be difficult to implement during routine health-care encounters. Multiple deprescribing interventions have been evaluated, which mostly include one or more of the following components: patient education, medication review, identification of deprescribing targets, and patient and/or provider communication about high-risk medications. Yet, there has been limited consideration of implementation factors in prior deprescribing interventions, especially with regard to the personnel and resources in existing health-care systems and the feasibility of incorporating components of deprescribing interventions into the routine care processes of clinicians. Future trials require a more balanced consideration of both effectiveness and implementation when designing deprescribing interventions.

Spiritual well-being and its relationship with patient characteristics and other patient-reported outcomes in peritoneal dialysis patients: Findings from the PDOPPS.

BACKGROUND: Spiritual well-being (SWB), an individual's understanding of the meaning and purpose of life, may help patients with chronic or terminal illnesses cope with their diseases. This study aimed to assess SWB in patients on peritoneal dialysis (PD), as well as its relationship with patient characteristics and patient-reported outcomes (PRO). METHODS: The data were obtained from questionnaires that formed part of the PD Outcomes and Practice Patterns Study (PDOPPS). Measures used in this study were SWB scores derived from the WHO quality of life, spirituality, religiousness and personal beliefs (WHOQOL-SRPB) tool including 32 items from eight facets; physical (PCS) and mental component summary (MCS) scores of the 12-Item Short-Form Health Survey (SF-12), Center of Epidemiologic Studies Depression Scale-10 (CES-D-10) scores, burden of kidney disease scores and functional status scores. RESULTS: Overall, 529 out of 848 participants (62%) completely responded to the questionnaires and were included in the analysis. Over two-thirds of PD patients (70%) had moderate or higher SWB scores. The SWB scores were significantly lower in patients with age >65 years and unemployed status. SWB scores positively correlated with higher PCS, MCS, burden of kidney disease scores and functional status scores, while negatively correlated with depression scores by CES-D-10 scale. Patients who reported significant depressive symptoms (CES-D-10 score ≥ 10) had significantly lower SWB scores. CONCLUSION: Better SWB was significantly associated with better health-related QOL (HRQOL) and the absence of depressive symptoms. SWB may be an essential consideration in the delivery of high-quality PD.

Recall of Genomic Testing Results Among Patients with Cancer.

BACKGROUND: Genomic testing of somatic and germline DNA has transformed cancer care. However, low genetic knowledge among patients may compromise care and health outcomes. Given the rise in genomic testing, we sought to understand patients' knowledge of their genetic test results. MATERIALS AND METHODS: We conducted a survey-based study with 85 patients at a comprehensive cancer center. We compared self-reported recall of (a) having had somatic/germline testing and (b) their specific somatic/germline results to the genomic test results documented in the medical record. RESULTS: Approximately 30% of patients did not recall having had testing. Of those who recalled having testing, 44% of patients with pathogenic/likely pathogenic germline mutations and 57% of patients with reported somatic alterations did not accurately recall their specific gene or variant-level results. CONCLUSION: Given significant knowledge gaps in patients' recall of genomic testing, there is a critical need to improve patient-directed education and return-of-results strategies.

KDOQI US Commentary on the 2020 ISPD Practice Recommendations for Prescribing High-Quality Goal-Directed Peritoneal Dialysis.

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.

Burden of Kidney Disease, Health-Related Quality of Life, and Employment Among Patients Receiving Peritoneal Dialysis and In-Center Hemodialysis: Findings From the DOPPS Program.

RATIONALE & OBJECTIVE: Individuals faced with decisions regarding kidney replacement therapy options need information on how dialysis treatments might affect daily activities and quality of life, and what factors might influence the evolution over time of the impact of dialysis on daily activities and quality of life. STUDY DESIGN: Observational cohort study. SETTING & PARTICIPANTS: 7,771 hemodialysis (HD) and peritoneal dialysis (PD) participants from 6 countries participating in the Peritoneal and Dialysis Outcomes and Practice Patterns Studies (PDOPPS/DOPPS). PREDICTORS: Patient-reported functional status (based on daily living activities), country, demographic and clinical characteristics, and comorbidities. OUTCOME: Employment status and patient-reported outcomes (PROs) including Kidney Disease Quality of Life (KDQOL) instrument physical and mental component summary scores (PCS, MCS), kidney disease burden score, and depression symptoms (Center for Epidemiologic Studies Depression Scale [CES-D] score > 10). ANALYTICAL APPROACH: Linear regression (PCS, MCS, kidney disease burden score), logistic regression (depression symptoms), adjusted for predictors plus 12 additional comorbidities. RESULTS: In both dialysis modalities, patients in Japan had the highest PCS and employment (55% for HD and 68% for PD), whereas those in the United States had the highest MCS score, lowest kidney disease burden, and lowest employment (20% in HD and 42% in PD). After covariate adjustment, the association of age, sex, dialysis vintage, diabetes, and functional status with PROs was similar in both modalities, with women having lower PCS and kidney disease burden scores. Lower functional status (score <11) was strongly associated with lower PCS and MCS scores, a much greater burden of kidney disease, and greater likelihood of depression symptoms (CES-D, >10). The median change in KDQOL-based PROs was negligible over 1 year in participants who completed at least 2 annual questionnaires. LIMITATIONS: Selection bias due to incomplete survey responses. Generalizability was limited to the dialysis populations of the included countries. CONCLUSIONS: Variation exists in quality of life, burden of kidney disease, and depression across countries but did not appreciably change over time. Functional status remained one of the strongest predictors of all PROs. Routine assessment of functional status may provide valuable insights for patients and providers in anticipating outcomes and support needs for patients receiving either PD or HD.

Establishing a Core Outcome Set for Autosomal Dominant Polycystic Kidney Disease: Report of the Standardized Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) Consensus Workshop.

The omission of outcomes that are of relevance to patients, clinicians, and regulators across trials in autosomal dominant polycystic kidney disease (ADPKD) limits shared decision making. The Standardized Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) Initiative convened an international consensus workshop on October 25, 2018, to discuss the identification and implementation of a potential core outcome set for all ADPKD trials. This article summarizes the discussion from the workshops and the SONG-PKD core outcome set. Key stakeholders including 11 patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, and researchers) attended the workshop. Four themes emerged: "Relevance of trajectory and impact of kidney function" included concerns about a patient's prognosis and uncertainty of when they may need to commence kidney replacement therapy and the lack of an early prognostic marker to inform long-term decisions; "Discerning and defining pain specific to ADPKD" highlighted the challenges in determining the origin of pain, adapting to the chronicity and repeated episodes of pain, the need to place emphasis on pain management, and to have a validated measure for pain; "Highlighting ADPKD consequences" encompassed cyst-related complications and reflected patient's knowledge because of family history and the hereditary nature of ADPKD; and "Risk for life-threatening but rare consequences" such as cerebral aneurysm meant considering both frequency and severity of the outcome. Kidney function, mortality, cardiovascular disease, and pain were established as the core outcomes for ADPKD.

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

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

Safety-Net Care for Maintenance Dialysis in the United States.

BACKGROUND: Although most American patients with ESKD become eligible for Medicare by their fourth month of dialysis, some never do. Information about where patients with limited health insurance receive maintenance dialysis has been lacking. METHODS: We identified patients initiating maintenance dialysis (2008-2015) from the US Renal Data System, defining patients as "safety-net reliant" if they were uninsured or had only Medicaid coverage at dialysis onset and had not qualified for Medicare by the fourth dialysis month. We examined four dialysis facility ownership categories according to for-profit/nonprofit status and ownership (chain versus independent). We assessed whether patients who were safety-net reliant were more likely to initiate dialysis at certain facility types. We also examined hospital-based affiliation. RESULTS: The proportion of patients <65 years initiating dialysis who were safety-net reliant increased significantly over time, from 11% to 14%; 73% of such patients started dialysis at for-profit/chain-owned facilities compared to 76% of all patients starting dialysis. Patients who were safety-net reliant had a 30% higher relative risk of initiating dialysis at nonprofit/independently owned versus for-profit/independently owned facilities (odds ratio, 1.30; 95% CI, 1.24 to 1.36); they had slightly lower relative risks of initiating dialysis at for-profit and non-profit chain-owned facilities, and were more likely to receive dialysis at hospital-based facilities. These findings primarily reflect increased likelihood of dialysis among patients without insurance at certain facility types. CONCLUSIONS: Although most patients who were safety-net reliant received care at for-profit/chain-owned facilities, they were disproportionately cared for at nonprofit/independently owned and hospital-based facilities. Ongoing loss of market share of nonprofit/independently owned outpatient dialysis facilities may affect safety net-reliant populations.

Establishing core outcome domains in pediatric kidney disease: report of the Standardized Outcomes in Nephrology-Children and Adolescents (SONG-KIDS) consensus workshops.

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.

Establishing a Core Outcome Set for Peritoneal Dialysis: Report of the SONG-PD (Standardized Outcomes in Nephrology-Peritoneal Dialysis) Consensus Workshop.

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.

Patient and Caregiver Priorities for Outcomes in CKD: A Multinational Nominal Group Technique Study.

RATIONALE & OBJECTIVE: Patients with chronic kidney disease (CKD) are at an increased risk for premature death, cardiovascular disease, and burdensome symptoms that impair quality of life. We aimed to identify patient and caregiver priorities for outcomes in CKD. STUDY DESIGN: Focus groups with nominal group technique. SETTING & PARTICIPANTS: Adult patients with CKD (all stages) and caregivers in the United States, Australia, and United Kingdom. ANALYTICAL APPROACH: Participants identified, ranked, and discussed outcomes that were important during the stages of CKD before kidney replacement therapy. For each outcome, we calculated a mean importance score (scale, 0-1). Qualitative data were analyzed using thematic analysis. RESULTS: 67 (54 patients, 13 caregivers) participated in 10 groups and identified 36 outcomes. The 5 top-ranked outcomes for patients were kidney function (importance score, 0.42), end-stage kidney disease (0.29), fatigue (0.26), mortality (0.25), and life participation (0.20); and for caregivers, the top 5 outcomes were life participation (importance score, 0.38), kidney function (0.37), mortality (0.23), fatigue (0.21), and anxiety (0.20). Blood pressure, cognition, and depression were consistently ranked in the top 10 outcomes across role (patient/caregiver), country, and treatment stage. Five themes were identified: re-evaluating and reframing life, intensified kidney consciousness, battling unrelenting and debilitating burdens, dreading upheaval and constraints, and taboo and unspoken concerns. LIMITATIONS: Only English-speaking participants were included. CONCLUSIONS: Patients and caregivers gave highest priority to kidney function, mortality, fatigue, life participation, anxiety, and depression. Consistent reporting of these outcomes in research may inform shared decision making based on patient and caregiver priorities in CKD.