Rationale & Objectives:To test a new patient-reported outcome measure that assesses end-stage kidney disease (ESKD) maintenance dialysis patients' experience with life goals discussions with their dialysis facility care team. Study Design:Observational cross-sectional study. Survey data collected via REDCap, paper form or telephone in a convenience sample of patients with ESKD receiving maintenance dialysis in the United States. Settings & Participants:People aged 18 years or older with ESKD receiving maintenance hemodialysis or peritoneal dialysis in US dialysis facilities between the June and December 2020 study period. Exposures:Testing of 6 items providing the core quality assessment and 1 item measuring whether 1 or more members of the treatment team discussed life goals with the patient. Outcomes:Preliminary reliability and validity of the Discussion of Patient Life Goals survey (D-PaLS). Analytic Approach:Exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and item response theory methods, including the graded response model (GRM) and differential item functioning (DIF). Results:Of 517 participants, 479 completed the survey via REDCap; 38 completed the survey via paper or telephone. EFA and CFA supported the unidimensionality of the 6 core items. GRM overall and item fit analyses and DIF analyses supported retention of all core items. Preliminary reliability data indicated very good internal consistency (Cronbach's alpha = 0.84). Known-groups validity was supported whereby individuals receiving home dialysis had more positive responses, than those receiving in-center hemodialysis. Limitations:Study participants were not fully representative of the US ESKD dialysis population. Conclusions:Preliminary analyses indicate the D-PaLS has excellent psychometric properties. The measure provides 2 important quality metrics: facilities' level of engagement talking with patients about their life goals and the percentage of patients reporting who on the treatment team talks with them about their life goals. Additional work is needed to establish comprehensive reliability and validity to support the clinical utility of this measure in patient care.

Rationale & Objectives:To report on the qualitative study supporting concept elicitation and item development for a new survey assessing discussion of patient life goals (D-PaLS) for people with kidney failure (KF) on maintenance dialysis. Study Design:Three-stage qualitative data collection using a semi-structured group discussion format with an expert panel (stage 1); 2 focus groups (stage 2); and cognitive debriefing interviews (stage 3). Setting & Participants:All participants were recruited nationally in the United States to obtain a diverse convenience sample of KF patients with maintenance dialysis experience, nephrologists, and dialysis clinic staff. Analytic Approach:Qualitative analysis of major themes to support life goals concept elicitation and survey item development and revision. Results:There was strong consensus for the development of a patient life goals patient-reported outcome measure to support the alignment of patient life goals with treatment planning. Themes from stage 1 included "quality gap-life goals discussions are not happening," "how life goals inform treatment planning," and "starting the life goals conversation." In stages 2 and 3, focus group feedback related to item interpretability; mix of item type; limiting survey burden; and preserving patient anonymity. The final survey contained 8 items (6 core items and 2 check-list items). Limitations:People that volunteered for participation may reflect self-selection. Conclusions:The new D-PaLS is a brief survey that was based on extensive input from patient and clinical provider stakeholders that supported elicitation of the measure concept and item development. The D-PaLS has the potential to support shared decision-making in treatment planning for people with KF. Stakeholder support is necessary throughout patient-reported outcome measure measure development to ensure content is meaningful and captures experiences and outcomes that are important to the patients.

Providing high-quality patient-centered care is the central mission of dialysis facilities. Assessing quality and patient-centeredness of dialysis care is necessary for continuous dialysis facility improvement. Based predominantly on readily measured items, current quality measures in dialysis care emphasize biochemical and utilization outcomes, with very few patient-reported items. Additionally, current metrics often do not account for patient preferences and may compromise patient-centered care by limiting the ability of providers to individualize care targets, such as dialysis adequacy, based on patient priorities rather than a fixed numerical target. Developing, implementing, and maintaining a quality program using readily quantifiable data while also allowing for individualization of care targets that emphasize the goals of patients and their care partners provided the motivation for a September 2022 Kidney Disease Outcomes Quality Initiative (KDOQI) Workshop on Patient-Centered Quality Measures for Dialysis Care. Workshop participants focused on 4 questions: (1) What are the outcomes that are most important to patients and their care partners? (2) How can social determinants of health be accounted for in quality measures? (3) How can individualized care be effectively addressed in population-level quality programs? (4) What are the optimal means for collecting valid and robust patient-reported outcome data? Workshop participants identified numerous gaps within the current quality system and favored a conceptually broader, but not larger, quality system that stresses highly meaningful and adaptive measures that incorporate patient-centered principles, individual life goals, and social risk factors. Workshop participants also identified a need for new, low-burden tools to assess patient goals and priorities.

BACKGROUND:Renal dialysis is a lifesaving but demanding therapy, requiring 3 weekly treatments of multiple-hour durations. Though travel times and quality of care vary across facilities, the extent to which patients are willing and able to engage in weighing tradeoffs is not known. Since 2015, Medicare has summarized and reported quality data for dialysis facilities using a star rating system. We estimate choice models to assess the relative roles of travel distance and quality of care in explaining patient choice of facility.RESEARCH DESIGN:Using national data on 2 million patient-years from 7198 dialysis facilities and 4-star rating releases, we estimated travel distance to patients' closest facilities, incremental travel distance to the next closest facility with a higher star rating, and the difference in ratings between these 2 facilities. We fit mixed effects logistic regression models predicting whether patients dialyzed at their closest facilities.RESULTS:Median travel distance was 4 times that in rural (10.9 miles) versus urban areas (2.6 miles). Higher differences in rating [odds ratios (OR): 0.56; 95% confidence interval (CI): 0.50-0.62] and greater area deprivation (OR: 0.50; 95% CI: 0.48-0.53) were associated with lower odds of attending one's closest facility. Stratified models were also fit based on urbanicity. For rural patients, excess travel was associated with higher odds of attending the closer facility (per 10 miles; OR: 1.05; 95% CI: 1.04-1.06). Star rating differences were associated with lower odds of receiving care from the closest facility among urban (OR: 0.57; 95% CI: 0.51-0.63) and rural patients (OR: 0.18; 95% CI: 0.08-0.44).CONCLUSIONS:Most dialysis patients have higher rated facilities located not much further than their closest facility, suggesting many patients could evaluate tradeoffs between distance and quality of care in where they receive dialysis. Our results show that such tradeoffs likely occur. Therefore, quality ratings such as the Dialysis Facility Compare (DFC) Star Rating may provide actionable information to patients and caregivers. However, we were not able to assess whether these associations reflect a causal effect of the Star Ratings on patient choice, as the Star Ratings served only as a marker of quality of care.

This article describes an estimated 6953–10 316 excess deaths among individuals with end-stage renal disease during the early months of the COVID-19 pandemic in February 2020–August 2020 (compared to death rates prior to the pandemic). Notably, the estimated number of excess deaths was reported as 10.8–16.6 per 1000 individuals on dialysis and 2.6–5.5 per 1000 individuals with a prior kidney transplantation. Although not adjusted for confounders, these data suggest that the immunosuppression associated with kidney transplantation is not a dominant determinant of outcomes associated with COVID-19 in this population.

IMPORTANCE There is a need for studies to evaluate the risk factors for COVID-19 and mortality among the entire Medicare long-term dialysis population using Medicare claims data. Objective To identify risk factors associated with COVID-19 and mortality in Medicare patients undergoing long-term dialysis. DESIGN, SETTING, AND PARTICIPANTS This retrospective, claims-based cohort study compared mortality trends of patients receiving long-term dialysis in 2020 with previous years (2013-2019) and fit Cox regression models to identify risk factors for contracting COVID-19 and postdiagnosis mortality. The cohort included the national population of Medicare patients receiving long-term dialysis in 2020, derived from clinical and administrative databases. COVID-19 was identified through Medicare claims sources. Data were analyzed on May 17, 2021. MAIN OUTCOMES AND MEASURES The 2 main outcomes were COVID-19 and all-cause mortality. Associations of claims-based risk factors with COVID-19 and mortality were investigated prediagnosis and postdiagnosis. RESULTS Among a total of 498 169 Medicare patients undergoing dialysis (median [IQR] age, 66 [56-74] years; 215 935 [43.1%] women and 283 227 [56.9%] men), 60 090 (12.1%) had COVID-19, among whom 15 612 patients (26.0%) died. COVID-19 rates were significantly higher among Black (21 787 of 165 830 patients [13.1%]) and Hispanic (13 530 of 86 871 patients [15.6%]) patients compared with non-Black patients (38 303 of 332 339 [11.5%]), as well as patients with short (ie, 1-89 days; 7738 of 55 184 patients [14.0%]) and extended (ie, >= 90 days; 10 737 of 30 196 patients [35.6%]) nursing home stays in the prior year. Adjusting for all other risk factors, residing in a nursing home 1 to 89 days in the prior year was associated with a higher hazard for COVID-19 (hazard ratio [HR] vs 0 days, 1.60; 95% CI 1.56-1.65) and for postdiagnosis mortality (HR, 1.31; 95% CI, 1.25-1.37), as was residing in a nursing home for an extended stay (COVID-19: HR, 4.48; 95% CI, 4.37-4.59; mortality: HR, 1.12; 95% CI, 1.07-1.16). Black race (HR vs non-Black: HR, 1.25; 95% CI, 1.23-1.28) and Hispanic ethnicity (HR vs non-Hispanic: HR, 1.68; 95% CI, 1.64-1.72) were associated with significantly higher hazards of COVID-19. Although home dialysis was associated with lower COVID-19 rates (HR, 0.77; 95% CI, 0.75-0.80), it was associated with higher mortality (HR, 1.18; 95% CI, 1.11-1.25). CONCLUSIONS AND RELEVANCE These results shed light on COVID-19 risk factors and outcomes among Medicare patients receiving long-term chronic dialysis and could inform policy decisions to mitigate the significant extra burden of COVID-19 and death in this population.

Objective To examine which factors are driving improvement in the Dialysis Facility Compare (DFC) star ratings and to test whether nonclinical facility characteristics are associated with observed longitudinal changes in the star ratings. Data Sources Data were collected from eligible patients in over 6,000 Medicare-certified dialysis facilities from three annual star rating and individual measure updates, publicly released on DFC in October 2015, October 2016, and April 2018. Study Design Changes in the star rating and individual quality measures were investigated across three public data releases. Year-to-year changes in the star ratings were linked to facility characteristics, adjusting for baseline differences in quality measure performance. Data Collection Data from publicly reported quality measures, including standardized mortality, hospitalization, and transfusion ratios, dialysis adequacy, type of vascular access for dialysis, and management of mineral and bone disease, were extracted from annual DFC data releases. Principal Findings The proportion of four- and five-star facilities increased from 30.0% to 53.4% between October 2015 and April 2018. Quality improvement was driven by the domain of care containing the dialysis adequacy and hypercalcemia measures. Additionally, independently owned facilities and facilities belonging to smaller dialysis organizations had significantly lower odds of year-to-year improvement than facilities belonging to either of the two large dialysis organizations (Odds Ratio [OR]: 0.736, 95% Confidence Interval [CI]: 0.631-0.856 and OR: 0.797, 95% CI: 0.723-0.879, respectively). Conclusions The percentage of four- and five-star facilities has increased markedly over a three-year time period. These changes were driven by improvement in the specific quality measures that may be most directly under the control of the dialysis facility.

In this month’s issue, Wright, et al. examine the ethical issues involved in the solicitation of grateful patient philanthropy.1 The physicians surveyed in their study identified a number of potential concerns with patient philanthropy, including the possibility of exploiting vulnerable patients and providing differential care based on patients’ level of giving. While the article does a good job of identifying the issues, we believe these issues should be considered in greater depth. Before we go into this discussion, however, we need a common understanding of what a gift is. According to Merriam-Webster, it is “something voluntarily transferred by one person to another without compensation.”2 In order to understand the ethics of gifts, it is important to understand why they are given in the first place. Richard Titmuss describes his extensive study of gifts in The Gift Relationship: From Human Blood To Social Policy.3 In this book, he looked specifically at blood donation but used this information to extrapolate towards gift giving as a whole. He did extensive surveys of the personal motivations and found that for a large majority of people, the act of gift giving stemmed from altruistic reasons, such as desire to help or express gratitude.4 In fact, the root of the word philanthropy translates to “love of humanity.” While there are definitely some individual benefits to giving, most individuals choose to give as a means of improving some aspect of society. Despite the potential upside of gifts in the form of philanthropy by grateful patients, patient vulnerability and the possibility of exploitation are perhaps the biggest ethical problems with this type of gift. Alan Wertheimer states, “an exploitative transaction is one in which A takes unfair advantage of B.”5 But is this the case in philanthropy? Philanthropy assumes that one party gives freely to another so that both can achieve a mutually beneficial goal. It assumes fairness and an equal amount of power. The donor has money, and the hospital can put it to good use.6 Certainly, there are some instances in which this is not the case. Someone who is demented or mentally ill cannot enter into a philanthropic relationship. In fact, some medical schools have deemed psychiatry departments as inappropriate for fundraising for this very reason.6 But for someone who is competent, philanthropy can be beneficial. It allows them to show gratitude for care they have received, it allows the patient to use his or her resources to help the physician combat illness, and it allows the patient to help others in a similar situation to his own. This is a consensual relationship, not unfair and the opposite of exploitation. It should be made clear that the decision to donate will not affect a patient’s care. Requests should be made outside of the clinical setting. But if these conditions are met, then philanthropy can be empowering to a patient and should be an available option. One of the other major concerns brought up by the physicians surveyed in the article was the worry that they were treating patients who had donated differently from their other patients and that they were introducing inequality into their care. Indeed, a central ethical issue in medical philanthropy is the concern that donors will get preferential treatment. Presumably, this is an expectation of some donors, and in many hospital settings, this is indeed the case. Some hospitals have developed special pavilions or medical concierge programs for donors. A survey of Connecticut emergency departments showed that more than half offered speedier service to “influential people,” including high dollar donors.7 Is this necessarily unethical, however? Most of the services offered to donors are amenities, and not crucial to the patient’s outcome. Examples of these include nicer rooms or a concierge who will attend a patient’s needs. As long as everyone receives the same basic level of medical care, there should be no ethical issues with these extra amenities. In fact, it has been argued that special treatment of “VIP’s” is beneficial to all patients.8 Diekema argued that preferential treatment for influential patients usually benefits the hospital, whether that be in terms of increased donations, political favor or good public relations. This in turn allows the hospital to improve care for all patients.8 Giving extra perks to these patients increases the utility for everyone. As long as the patient realizes that his actual medical care will stay the same, there should be little ethical problem with this. It is interesting that a majority of respondents in Wright’s study were able to identify potential ethical problems with soliciting money from patients, but did not have a problem themselves asking for gifts, similar to the belief by many physicians that gifts and inducements from pharmaceutical companies altered the prescribing behaviors of other physicians, but not themselves.9 When people realize there is a potential for unethical behavior, but don’t believe it applies to them personally, there may be a need for increased training, scrutiny, and regulation. One solution is to teach the guidelines that already exist for the appropriate time, place and manner in which to solicit gifts; they do a good job of outlining how physicians can avoid these potentially sticky issues. For example, the American Medical Association’s (AMA) Council on Ethical and Judicial Affairs (CEJA), recommends that physicians should avoid soliciting donations from their own patients, and if they do, the “ask” should be clearly separated from the clinical encounter. The AMA also indicates that the health care facility should make it clear to the patient that their welfare is the primary concern. Ideally, according to the AMA, solicitation should come from other doctors (i.e. those not directly involved in the patient’s care) or fundraising personnel.10 These limitations can decrease the potential for a conflict of interest and should be common practice. The guidelines prevent solicitations when the patient is most vulnerable and should minimize effects on the doctor–patient relationship. While care must be taken to avoid pressuring the patient or taking advantage of a patient’s illness, not all of the issues raised in the article are necessarily unethical or problematic. There should be a continuing discussion of these ethical issues as philanthropy becomes a more important source of funding for medical institutions.

BACKGROUND:Racial disparities in health care are widespread in the United States. Identifying contributing factors may improve care for underserved minorities. To the extent that differential utilization of services, based on need or biological effect, contributes to outcome disparities, prospective payment systems may require inclusion of race to minimize these adverse effects. This research determines whether costs associated with end-stage renal disease (ESRD) care varied by race and whether this variance affected payments to dialysis facilities.STUDY DESIGN:We compared the classification of race across Medicare databases and investigated differences in cost of care for long-term dialysis patients by race.SETTING & PARTICIPANTS:Medicare ESRD database including 890,776 patient-years in 2004-2006.PREDICTORS:Patient race and ethnicity.OUTCOMES:Costs associated with ESRD care and estimated payments to dialysis facilities under a prospective payment system.RESULTS:There were inconsistencies in race and ethnicity classification; however, there was significant agreement for classification of black and nonblack race across databases. In predictive models evaluating the cost of outpatient dialysis care for Medicare patients, race is a significant predictor of cost, particularly for cost of separately billed injectable medications used in dialysis. Overall, black patients had 9% higher costs than nonblack patients. In a model that did not adjust for race, other patient characteristics accounted for only 31% of this difference.LIMITATIONS:Lack of information about biological causes of the link between race and cost.CONCLUSIONS:There is a significant racial difference in the cost of providing dialysis care that is not accounted for by other factors that may be used to adjust payments. This difference has the potential to affect the delivery of care to certain populations. Of note, inclusion of race into a prospective payment system will require better understanding of biological differences in bone and anemia outcomes, as well as effects of inclusion on self-reported race.