Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial).

BACKGROUND: Most patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance. Observational studies suggest that patients with residual kidney function can safely be treated with incremental prescriptions of HD, starting with less frequent sessions and later adjusting to thrice-weekly HD. This trial aims to show objectively that clinically matched incremental HD (CMIHD) is non-inferior to CHD in eligible patients. METHODS: An unblinded, parallel-group, randomized controlled trial will be conducted across diverse healthcare systems and dialysis organizations in the USA. Adult patients initiating chronic hemodialysis (HD) at participating centers will be screened. Eligibility criteria include receipt of fewer than 18 treatments of HD and residual kidney function defined as kidney urea clearance ≥3.5 mL/min/1.73 m2 and urine output ≥500 mL/24 h. The 1:1 randomization, stratified by site and dialysis vascular access type, assigns patients to either CMIHD (intervention group) or CHD (control group). The CMIHD group will be treated with twice-weekly HD and adjuvant pharmacologic therapy (i.e., oral loop diuretics, sodium bicarbonate, and potassium binders). The CHD group will receive thrice-weekly HD according to usual care. Throughout the study, patients undergo timed urine collection and fill out questionnaires. CMIHD will progress to thrice-weekly HD based on clinical manifestations or changes in residual kidney function. Caregivers of enrolled patients are invited to complete semi-annual questionnaires. The primary outcome is a composite of patients' all-cause death, hospitalizations, or emergency department visits at 2 years. Secondary outcomes include patient- and caregiver-reported outcomes. We aim to enroll 350 patients, which provides ≥85% power to detect an incidence rate ratio (IRR) of 0.9 between CMIHD and CHD with an IRR non-inferiority of 1.20 (α = 0.025, one-tailed test, 20% dropout rate, average of 2.06 years of HD per patient participant), and 150 caregiver participants (of enrolled patients). DISCUSSION: Our proposal challenges the status quo of HD care delivery. Our overarching hypothesis posits that CMIHD is non-inferior to CHD. If successful, the results will positively impact one of the highest-burdened patient populations and their caregivers. TRIAL REGISTRATION: Clinicaltrials.gov NCT05828823. Registered on 25 April 2023.

Sex bias in prediction and diagnosis of cardiac surgery associated acute kidney injury.

BACKGROUND: Female sex has been recognized as a risk factor for cardiac surgery associated acute kidney injury (CS-AKI). The current study sought to evaluate whether female sex is a risk factor for CS-AKI, or modifies the association of peri-operative change in serum creatinine with CS-AKI. METHODS: Observational study of adult patients undergoing cardiac surgery between 2000 and 2019 in a single U.S. center. The main variable of interest was registered patient sex, identified from electronic medical records. The main outcome was CS-AKI within 2 weeks of surgery. RESULTS: Of 58526 patients, 19353 (33%) were female; 12934 (22%) incurred AKI based on ≥ 0.3 mg/dL or ≥ 50% rise in serum creatinine (any AKI), 3320 (5.7%) had moderate to severe AKI, and 1018 (1.7%) required dialysis within 2 weeks of surgery. Female sex was associated with higher risk for AKI in models that were based on preoperative serum creatinine (OR, 1.35; 95% CI, 1.29-1.42), and lower risk with the use of estimated glomerular filtration, (OR, 0.90; 95% CI, 0.86-0.95). The risk for moderate to severe CS-AKI for a given immediate peri-operative change in serum creatinine was higher in female compared to male patients (p < .0001 and p < .0001 for non-linearity), and the association was modified by pre-operative kidney function (p < .0001 for interaction). CONCLUSIONS: The association of patient sex with CS-AKI and its direction was dependent on the operational definition of pre-operative kidney function, and differential outcome misclassification due to AKI defined by absolute change in serum creatinine.

Sex Bias in Prediction and Diagnosis of Cardiac Surgery Associated Acute Kidney Injury.

Background: Female sex has been recognized as a risk factor for cardiac surgery associated acute kidney injury (CS-AKI). The current study sought to evaluate whether female sex is a risk factor for CS-AKI, or modifies the association of peri-operative change in serum creatinine with CS-AKI. Methods: Observational study of adult patients undergoing cardiac surgery between 2000 and 2019 in a single U.S. center. The main variable of interest was registered patient sex, identified from electronic medical records. The main outcome was CS-AKI within 2 weeks of surgery. Results: Of 58526 patients, 19353 (33%) were female; 12934 (22%) incurred AKI based on ≥ 0.3 mg/dL or ≥ 50% rise in serum creatinine (any AKI), 3320 (5.7%) had moderate to severe AKI, and 1018 (1.7%) required dialysis within 2 weeks of surgery. Female sex was associated with higher risk for AKI in models that were based on preoperative serum creatinine (OR, 1.35; 95% CI, 1.29-1.42), and lower risk with the use of estimated glomerular filtration, (OR, 0.90; 95% CI, 0.86-0.95). The risk for moderate to severe CS-AKI for a given immediate peri-operative change in serum creatinine was higher in female compared to male patients (p < .0001 and p < .0001 for non-linearity), and the association was modified by pre-operative kidney function (p < .0001 for interaction). Conclusions: The association of patient sex with CS-AKI and its direction was dependent on the operational definition of pre-operative kidney function, and differential outcome misclassification due to AKI defined by absolute change in serum creatinine.

Hemodynamic Determinants of Cardiac Surgery-Associated Acute Kidney Injury.

OBJECTIVES: Examine the: 1) relative role of hemodynamic determinants of acute kidney injury (AKI) obtained in the immediate postcardiac surgery setting compared with established risk factors, 2) their predictive value, and 3) extent mediation via central venous pressure (CVP) and mean arterial pressure (MAP). DESIGN: Retrospective observational study. The main outcome of the study was moderate to severe AKI, per kidney disease: improving global outcomes, within 14 days of surgery. SETTING: U.S. academic medical center. PATIENTS: Adult patients undergoing cardiac surgery between January 2000 and December 2019 (n = 40,426) in a single U.S.-based medical center. Pulmonary artery catheter measurements were performed at a median of 102 minutes (11, 132) following cardiopulmonary bypass discontinuation. INTERVENTIONS: None. MEASUREMENTS AND RESULTS: The median age of the cohort was 67 years (58, 75), and 33% were female; 70% had chronic hypertension, 29% had congestive heart failure, and 3% had chronic kidney disease. In a multivariable model, which included comorbidities and traditional intraoperative risk factors, CVP (p < 0.0001), heart rate (p < 0.0001), cardiac index (p < 0.0001), and MAP (p < 0.0001), were strong predictors of AKI, and superseded factors such as surgery type and cardiopulmonary bypass duration. The cardiac index had a significant interaction with heart rate (p = 0.026); a faster heart rate had a differentiating effect on the relationship of cardiac index with AKI, where a higher heart rate heightened the risk of AKI primarily in patients with low cardiac output. There was also significant interaction observed between CVP and MAP (p = 0.009); where the combination of elevated CVP and low MAP had a synergistic effect on AKI incidence. CONCLUSIONS: Hemodynamic factors measured within a few hours of surgery showed a strong association with AKI. Furthermore, determinants of kidney perfusion, namely CVP and arterial pressure are interdependent; as are constituents of stroke volume, that is, cardiac output and heart rate.

Psychosocial characteristics of potential and actual living kidney donors.

The psychosocial assessment is an essential component of the living kidney donor (LKD) evaluation. However, it remains uncertain how specific psychosocial factors impact LKD eligibility. We performed a retrospective chart review of LKD candidates who initiated the evaluation process and who had completed a required, in-person licensed social work (LSW) visit. LSW notes were reviewed for frequency of psychosocial factors that may impact the success of LKD candidate approval by the selection committee. 325 LKD candidates were included in the study: 104 not-approved and 221 approved. Not-approved LKD candidates were more likely to receive a negative family reaction to wanting to donate than approved LKD candidates (8.7% vs 1.4%, p < 0.01). On multivariate analysis, Black race, history of psychiatric illness, highest level of education being high school, and high psychosocial risk score assignment were all associated with a lower odds ratio of being approved. The majority of not-approved LKD candidates were disqualified for medical reasons (N = 76, 73.1%). In conclusion, psychosocial factors impact donation even after LKD candidates make it to an in-person evaluation.

Relationship of Social Deprivation Among Living Kidney Donor-Recipient Pairs.

Background: Living kidney transplant is the most effective renal replacement therapy for patients with end-stage kidney disease. Community-level factors contribute to pervasive socioeconomic and racial disparities in access to living donor kidney transplantation. Little is known about social and environmental conditions between living donors and recipients. Further understanding of these relationships may enhance opportunities for transplantation. Methods: From 2010 to 2020, 59 575 living kidney donor-recipient pairs (≥18 y old) were identified using the Scientific Registry of Transplant Recipients. Living donors and recipients were geocoded to area-level social deprivation index (SDI). The primary outcome was difference between recipient and donor SDI. We used multivariable logistic regression to examine recipient and donor characteristics association with residence in different SDI communities. Results: Living kidney donation occurs across all strata of social deprivation; including when donors, recipients or both reside in more disadvantaged communities. Donor-recipient race combination and biological relationship are associated with differences in SDI. When compared with White recipients of White donors, Black and Hispanic recipients were more likely to reside in more disadvantaged areas (odds ratio = 2.41 [2.19-2.66] and 1.97 [1.78-2.19]). Recipients in anonymous and paired donations were more likely to reside in areas of more disadvantage than their donors (odds ratio = 1.27 [1.15-1.40] and 1.32 [1.23-1.41] compared with biological); attenuating socioeconomic disparities in access to living donor transplantation. Conclusions: Findings illustrate the social and environmental relationships between living kidney donor-recipient pairs that are important to develop targeted approaches and address barriers to living kidney transplantation. Best practices from areas of high deprivation with successful living kidney transplantation can be shared.

Discrepant Outcomes between National Kidney Transplant Data Registries in the United States.

SIGNIFICANCE STATEMENT: Effects of reduced access to external data by transplant registries to improve accuracy and completeness of the collected data are compounded by different data management processes at three US organizations that maintain kidney transplant-related datasets. This analysis suggests that the datasets have large differences in reported outcomes that vary across different subsets of patients. These differences, along with recent disclosure of previously missing outcomes data, raise important questions about completeness of the outcome measures. Differences in recorded deaths seem to be increasing in recent years, reflecting the adverse effects of restricted access to external data sources. Although these registries are invaluable sources for the transplant community, discrepancies and incomplete reporting risk undermining their value for future analyses, particularly when used for developing national transplant policy or regulatory measures. BACKGROUND: Central to a transplant registry's quality are accuracy and completeness of the clinical information being captured, especially for important outcomes, such as graft failure or death. Effects of more limited access to external sources of death data for transplant registries are compounded by different data management processes at the United Network for Organ Sharing (UNOS), the Scientific Registry of Transplant Recipients (SRTR), and the United States Renal Data System (USRDS). METHODS: This cross-sectional registry study examined differences in reported deaths among kidney transplant candidates and recipients of kidneys from deceased and living donors in 2000 through 2019 in three transplant datasets on the basis of data current as of 2020. We assessed annual death rates and survival estimates to visualize trends in reported deaths between sources. RESULTS: The UNOS dataset included 77,605 deaths among 315,346 recipients and 61,249 deaths among 275,000 nonpreemptively waitlisted candidates who were never transplanted. The SRTR dataset included 87,149 deaths among 315,152 recipients and 60,042 deaths among 259,584 waitlisted candidates. The USRDS dataset included 89,515 deaths among 311,955 candidates and 63,577 deaths among 238,167 waitlisted candidates. Annual death rates among the prevalent transplant population show accumulating differences across datasets-2.31%, 4.00%, and 4.03% by 2019 from UNOS, SRTR, and USRDS, respectively. Long-term survival outcomes were similar among nonpreemptively waitlisted candidates but showed more than 10% discordance between USRDS and UNOS among transplanted patients. CONCLUSIONS: Large differences in reported patient outcomes across datasets seem to be increasing, raising questions about their completeness. Understanding the differences between these datasets is essential for accurate, reliable interpretation of analyses that use these data for policy development, regulatory oversight, and research. PODCAST: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/JASN/2023_10_24_JASN0000000000000194.mp3.

Deceased donor kidneys from higher distressed communities are significantly less likely to be utilized for transplantation.

The proportion of kidneys procured for transplantation but not utilized exceeds 20% in the United States. Factors associated with nonutilization are complex, and further understanding of novel causes are critically important. We used the national Scientific Registry of Transplant Recipients data (2010-2022) to evaluate associations of Distressed Community Index (DCI) of deceased donor residence and likelihood of kidney nonutilization (n = 209 413). Deceased donors from higher distressed communities were younger, had an increased history of hypertension and diabetes, were CDC high-risk, and had higher terminal creatinine and donation after brain death. Mechanisms and circumstances of death varied significantly by DCI. The proportion of kidney nonutilization was 19.9%, which increased by DCI quintile (Q1 = 18.1% to Q5 = 21.6%). The adjusted odds ratio of nonutilization from the highest quintile DCI communities was 1.22 (95% CI = 1.16-1.28; reference = lowest DCI), which persisted stratified by donor race. Donors from highly distressed communities were highly variable by the donor service area (range: 1%-51%; median = 21%). There was no increased risk for delayed graft function or death-censored graft loss by donor DCI but modest increased adjusted hazard for overall graft loss (high DCI = 1.05; 95% CI = 1.01-1.10; reference = lowest DCI). Results indicate that donor residential distress is associated with significantly higher rates of donor kidney nonutilization with notable regional variation and minimal impact on recipient outcomes.

Characteristics of Potential and Actual Living Kidney Donors: A Single-center Experience.

BACKGROUND: There are limited data and no national capture of barriers associated with initiating and completing the donation process for potential living kidney donors (LKDs). METHODS: We performed a retrospective analysis of 3001 intake forms completed by prospective LKDs from 2016 to 2019 at a single transplant center. We analyzed data from all potential donors who completed the intake until they became ineligible or withdrew or donation was complete. We used univariate and multivariate models to evaluate independent factors associated with donation at various stages in the donation process. RESULTS: The donation process was deconstructed into 5 steps: intake form, immunologic compatibility testing, clinic evaluation, selection committee review, and donation. The highest percentage of potential donors dropped out after completing the intake form, primarily because of not responding to the follow-up phone call (22.6%). Of 455 potential LKDs that completed immunologic compatibility testing, 36% were ABO or crossmatch incompatible. One-hundred eighty-eight (7.5%) of all LKD applicants reached donation, the majority of whom were White (91.0%) and female (63.8%). CONCLUSIONS: A minority of LKD applicants make it to donation. Our ability to track all potential LKDs from the initial touch point to the transplant center will help us develop interventions to address barriers to a successful donation.

Community Members as Reviewers of Medical Journal Manuscripts: a Randomized Controlled Trial.

BACKGROUND: Community members may provide useful perspectives on manuscripts submitted to medical journals. OBJECTIVE: To determine the impact of community members reviewing medical journal manuscripts. DESIGN: Randomized controlled trial involving 578 original research manuscripts submitted to two medical journals from June 2018 to November 2021. PARTICIPANTS: Twenty-eight community members who were trained, supervised, and compensated. INTERVENTIONS: A total of 289 randomly selected control manuscripts were reviewed by scientific reviewers only. And 289 randomly selected intervention manuscripts were reviewed by scientific reviewers and one community member. Journal editorial teams used all reviews to make decisions about acceptance, revision, or rejection of manuscripts. MAIN MEASURES: Usefulness of reviews to editors, content of community reviews, and changes made to published articles in response to community reviewer comments. KEY RESULTS: Editor ratings of community and scientific reviews averaged 3.1 and 3.3, respectively (difference 0.2, 95% confidence interval [CI] 0.1 to 0.3), on a 5-point scale where a higher score indicates a more useful review. Qualitative analysis of the content of community reviews identified two taxonomies of themes: study attributes and viewpoints. Study attributes are the sections, topics, and components of manuscripts commented on by reviewers. Viewpoints are reviewer perceptions and perspectives on the research described in manuscripts and consisted of four major themes: (1) diversity of study participants, (2) relevance to patients and communities, (3) cultural considerations and social context, and (4) implementation of research by patients and communities. A total of 186 community reviewer comments were integrated into 64 published intervention group articles. Viewpoint themes were present more often in 66 published intervention articles compared to 54 published control articles (2.8 vs. 1.7 themes/article, difference 1.1, 95% CI 0.4 to 1.8). CONCLUSIONS: With training, supervision, and compensation, community members are able to review manuscripts submitted to medical journals. Their comments are useful to editors, address topics relevant to patients and communities, and are reflected in published articles. TRIAL REGISTRATION: ClinicalTrials.gov NCT03432143.

Geographic hot spots of kidney transplant candidates wait-listed post-dialysis.

INTRODUCTION: Preemptive wait-listing of deceased donor kidney transplant (DDKT) candidates before maintenance dialysis increases the likelihood of transplantation and improves outcomes among transplant patients. Previous studies have identified substantial disparities in rates of preemptive listing, but a gap exists in examining geographic sources of disparities, particularly for sub-regional units. Identifying small area hot spots where delayed listing is particularly prevalent may more effectively inform both health policy and regionally appropriate interventions. METHODS: We conducted a retrospective cohort study utilizing 2010-2020 Scientific Registry of Transplant Recipients (SRTR) data for all DDKT candidates to examine overall and race-stratified geospatial hot spots of post-dialysis wait-listing in U.S. zip code tabulation areas (ZCTA). Three geographic clustering methods were utilized to identify robust statistically significant hot spots of post-dialysis wait-listing. RESULTS: Novel sub-regional hot spots were identified in the southeast, southwest, Appalachia, and California, with a majority existing in the southeast. Race-stratified results were more nuanced, but broadly reflected similar patterns. Comparing transplant candidates in hot spots to candidates in non-clusters indicated a strong association between residence in hot spots and high area deprivation (OR: 6.76, 95%CI: 6.52-7.02), indicating that improving access healthcare in these areas may be particularly beneficial. CONCLUSION: Our study identified overall and race-stratified hot spots with low rates of preemptive wait list placement in the U.S., which may be useful for prospective healthcare policy and interventions via targeting of these narrowly defined geographical areas.

Sources of Variation in the Carbon Footprint of Hemodialysis Treatment.

BACKGROUND: Greenhouse gas emissions from hemodialysis treatment in the United States have not been quantified. In addition, no previous studies have examined how much emissions vary across facilities, treatments, and emission contributors. METHODS: To estimate the magnitude and sources of variation in the carbon footprint of hemodialysis treatment, we estimated life-cycle greenhouse gas emissions in carbon dioxide equivalents (CO2-eq) associated with 209,481 hemodialysis treatments in 2020 at 15 Ohio hemodialysis facilities belonging to the same organization. We considered emissions from electricity, natural gas, water, and supply use; patient and staff travel distance; and biohazard and landfill waste. RESULTS: Annual emissions per facility averaged 769,374 kg CO2-eq (95% CI, 709,388 to 848,180 kg CO2-eq). The three largest contributors to total emissions were patient and staff transportation (28.3%), electricity (27.4%), and natural gas (15.2%). Emissions per treatment were 58.9 kg CO2-eq, with a three-fold variation across facilities. The contributors with the largest variation in emissions per treatment were transportation, natural gas, and water (coefficients of variation, 62.5%, 42.4%, and 37.7%, respectively). The annual emissions per hemodialysis facility are equivalent to emissions from the annual energy use in 93 homes; emissions per treatment are equivalent to driving an average automobile for 238 km (149 miles). CONCLUSIONS: Similar medical treatments provided in a single geographic region by facilities that are part of the same organization may be expected to have small variations in the determinants of greenhouse gas emissions. However, we found substantial variation in carbon footprints across facilities, treatments, and emission contributors. Understanding the magnitude and variation in greenhouse gas emissions may help identify measures to reduce the environmental effect of hemodialysis treatment.

A tool for decision-making in kidney transplant candidates with poor prognosis to receive deceased donor transplantation in the United States.

The primary outcomes for kidney transplant candidates are receipt of deceased or living donor transplant, death or removal from the waiting list. Here, we conducted a retrospective analysis of national Scientific Registry of Transplant Recipients data to evaluate outcomes for 208,717 adult kidney transplant candidates following the 2014 Kidney Allocation System in the United States. Competing risks models were utilized to evaluate Time to Equivalent Risk (TiTER) of deceased donor transplantation (DDTX) and death versus waitlist removal. We also evaluated TiTER based on kidney donor profile index (KDPI) and donor age. For all groups, the cumulative incidence of DDTX was initially higher from time of listing than death or waitlist removal. However, following accrued time on the waiting list, the cumulative incidence of death or waitlist removal exceeded DDTX for certain patient groups, particularly older, diabetic, blood type B and O and shorter pre-listing dialysis time. TiTER for all candidates aged 65-69 averaged 41 months and for 70 and older patients 28 months. Overall, 39.6% of candidates were in risk groups with TiTER under 72 months and 18.5% in groups with TiTER under 24 months. Particularly for older candidates, TiTER for kidneys was substantially shorter for younger donors or lower KDPI. Thus, our findings reveal that a large proportion of wait-listed patients in the United States have poor prognoses to ever undergo DDTX and our data may improve shared decision-making for candidates at time of waitlist placement. Hence, for specific patient groups, TiTER may be a useful tool to disseminate and quantify benefits of accepting relatively high risk donor organs.

Self-reported marijuana use and its effects on overall approval in potential living kidney donors.

BACKGROUND: Past and present substance use is an important part of the psychosocial evaluation of potential living kidney donors (LKDs). Increasing state legalizations and social acceptance of marijuana (MJ) use can create challenges for transplant centers. METHODS: We investigated the frequency of reporting MJ use, and its effect on the LKD evaluation. A retrospective chart review was performed on all living donor candidates from December 2016 to December 2019 for reports of MJ use, both on an electronic intake form and during clinical evaluation with a licensed social worker (SW). Active MJ use was defined as current use or use within 1 year of evaluation. Baseline characteristics between MJ users and non-users were compared at each step of donor evaluation. We explored variables associated with MJ use including additional consults and testing during the donor evaluation. Overall approval and donation rates for living donors with active MJ use were compared to non-users. Additionally, 1-year donor follow-up was compared between the two groups. Results of 1818 living donor candidates who completed the intake form, 132 admitted to active MJ use. Compared to non-users, MJ users were more likely to be younger, male, single, renting a home, and with a lower level of education. Thirty three out of 338 candidates who completed a social work evaluation reported MJ use. Compared to non-users, MJ users were more frequently classified as moderate or high risk on SW evaluation, and often required a toxicology screen or psychiatry visit for clearance to donate. Altogether 24.2% of MJ users versus 9.5% of non-users discontinued their evaluation (p < .01). Altogether 42.4% of MJ users versus 56.1% of non-users donated their kidney (p = .13). For those who donated, MJ users were less likely than non-users to follow up at 1 year (57.1% vs. 83.0, p-value .02). CONCLUSION: MJ users were often asked to complete additional steps in their evaluation before an approval decision was made, which may have led to the higher rate of donor drop out observed in this group. Further research is needed to assess the effects of MJ use on living donor candidacy, as well as any effects of MJ use on long-term donor outcomes.

Directly Observed Weekly Fluoxetine for Major Depressive Disorder Among Hemodialysis Patients: A Single-Arm Feasibility Trial.

Rationale & Objective: Major depressive disorder (MDD) is common among hemodialysis patients, but treatment can add to their pill burden and may be limited by nonadherence. We sought to investigate the value of directly observed, once-weekly fluoxetine dosing in MDD. Study Design: Feasibility trial of adult hemodialysis patients with untreated MDD. The diagnosis of MDD was determined using the Mini International Neuropsychiatric Interview. Setting & Participants: 16 patients at 15 hemodialysis facilities in Northeast Ohio. Intervention: Patients were initially prescribed 20 mg of fluoxetine once daily for 2 weeks to assess their tolerance. The patients took this daily fluoxetine unobserved at home. They were then transitioned to 90 mg of fluoxetine once weekly for 10 weeks. The patients took this weekly fluoxetine during hemodialysis treatment and were observed by the study staff. The dose was increased to 180 mg once weekly among patients with an inadequate response based on the judgment of the prescribing clinician. Outcomes: Mini International Neuropsychiatric Interview diagnosis of MDD at the end of the trial and changes in the Patient Health Questionnaire (PHQ-9) scores over 12 weeks. Results: One patient withdrew from active treatment after 2 daily doses of 20 mg of fluoxetine because of side effects of stomach cramping, vomiting, dizziness, and lightheadedness but completed the baseline and final assessments. The remaining 15 patients received all scheduled weekly fluoxetine doses during the trial. At 12 weeks, 14 of 16 patients (87.5%) no longer met the criteria for MDD (P < 0.001). Among all participants, the mean PHQ-9 scores decreased from 11.3 to 6.6 (P = 0.002). Limitations: Small sample size, modestly elevated baseline PHQ-9 scores, no comparison group, and short treatment duration. Conclusions: Directly observed, once-weekly fluoxetine may be an effective and well-tolerated treatment option for hemodialysis patients. Future research should investigate longer-term health outcomes of weekly fluoxetine in this population and explore the feasibility of implementing this depression treatment model in routine clinical practice. Trial Registration: This trial was registered at clinicaltrials.gov as NCT03390933.

A Population Health Approach to Transplant Access: Challenging the Status Quo.

Transplant referral and evaluation are critical steps to waitlisting yet remain an elusive part of the transplant process. Despite calls for more data collection on pre-waitlisting steps, there are currently no national surveillance data to aid in understanding the causes and potential solutions for the extreme variation in access to transplantation. As population health scientists, epidemiologists, clinicians, and ethicists we submit that the transplant community has an obligation to better understand disparities in transplant access as a first necessary step to effectively mitigating these inequities. Our position is grounded in a population health approach, consistent with several new overarching national policy and quality initiatives. The purpose of this Perspective is to (1) provide an overview of how a population health approach should inform current multisystem policies impacting kidney transplantation and demonstrate how these efforts could be enhanced with national data collection on pre-waitlisting steps; (2) demonstrate the feasibility and concrete next steps for pre-waitlisting data collection; and (3) identify potential opportunities to use these data to implement effective population-level interventions, policies, and quality measures to improve equity in access to kidney transplantation.