Patient-Reported Outcome Measures for Patients With CKD: The Case for Patient-Reported Outcomes Measurement Information System (PROMIS) Tools.

Chronic kidney disease (CKD), kidney failure, and kidney replacement therapies are associated with high symptom burden and impaired health-related quality of life (HRQOL). Symptoms change with disease progression or transition between treatment modalities and frequently go unreported and unmanaged. Tools that reliably monitor symptoms may improve the management of patients with CKD. Patient-reported outcome measures (PROMs) assess symptom severity; physical, psychological, social, and cognitive functioning; treatment-related side effects; and HRQOL. Systematic use of PROMs can improve patient-provider communication, patient satisfaction, clinical outcomes, and HRQOL. Potential barriers to their use include a lack of engagement, response burden, and limited guidance about PROM collection, score interpretation, and workflow integration. Well-defined, acceptable, and effective clinical response pathways are essential for implementing PROMs. PROMs developed by the Patient-Reported Outcomes Measurement Information System (PROMIS) address some challenges and may be suitable for clinical use among patients with CKD. PROMIS tools assess multiple patient-valued, clinically actionable symptoms and functions. They can be administered as fixed-length, customized short forms or computer adaptive tests, offering precise measurement across a range of symptom severities or function levels, tailored questions to individuals, and reduced question burden. Here we provide an overview of the potential use of PROMs in CKD care, with a focus on PROMIS.

Reliability, validity, and change thresholds of the NCCN/FACT Bladder Symptom Index (NFBlSI-18) in patients with advanced urothelial cancer.

BACKGROUND: The NCCN/FACT Bladder Symptom Index-18 (NFBlSI-18) is a bladder cancer-specific instrument. We aimed to psychometrically evaluate the reliability and validity of NFBlSI-18 and estimate change thresholds for total, disease-related symptoms-physical (DRS-P), DRS-emotional (DRS-E), and function/well-being (F/WB) scales in patients with locally advanced/metastatic urothelial cancer (la/mUC). METHODS: JAVELIN Bladder 100 trial data were analyzed. Anchors to evaluate validity included: 5-level EuroQoL-5D utility index (EQ-5D-5L UI), visual analog scale (VAS), Eastern Cooperative Oncology Group (ECOG) performance status, and number of symptoms. Responsiveness to change was tested by anchoring to time to tumor progression (TTP), best overall response (BOR), and differences in means between ECOG categories to estimate meaningful between-group differences. Meaningful within-group change thresholds were estimated using receiver operating characteristic curve analysis, anchoring to change in EQ-5D-5L UI. Significant within-individual patient change thresholds were estimated with reliable and likely change indexes. RESULTS: Correlations with EQ-5D-5L UI and VAS ranged from 0.53 to 0.73. Standardized effect sizes were >0.20. Compared with patients with TTP of ≥6 months, patients with TTP of >0-2 and 3-5 months had larger declines; results for BOR were similar. Thresholds (points) for meaningful between-group differences were: total, 6-11; DRS-P, 3-6; and DRS-E and F/WB, 1. Thresholds (points) for meaningful within-group worsening were: total, 4; and DRS-P, 3, and for significant individual change they were: total, 3-9; DRS-P, 2-6; DRS-E, 1-3; and F/WB, 2-4. CONCLUSIONS: NFBlSI-18 exhibited evidence of reliability, validity, and responsiveness to assess quality of life in studies of la/mUC, and change thresholds are established for future studies. PLAIN LANGUAGE SUMMARY: The NCCN/FACT Bladder Symptom Index-18 (NFBlSI-18) is a questionnaire used to assess quality of life for people with advanced bladder cancer. People with advanced bladder cancer who took part in the JAVELIN Bladder 100 study completed the NFBlSI-18 when they joined the study and after each treatment with avelumab maintenance or best supportive care. This study showed that NFBlSI-18 is suitable for capturing bladder cancer symptoms and is able to detect important changes in a person's quality of life over time. This study also provides thresholds for changes in NFBlSI-18 scores, which will be useful for future studies.

Adverse COVID-19 experiences and health-related quality of life in cancer survivors: indirect effects of COVID-19-related depression and financial burden.

BACKGROUND: Cancer survivors are at greater risk for poor health outcomes due to COVID-19. However, the pandemic's impact on patients' health-related quality of life (HRQoL) is not well known. This study hypothesized that cancer survivors' adverse COVID-19 experiences would be associated with worse HRQoL. Further, this association would be moderated by psychosocial resiliency factors (perceived social support, benefits, and ability to manage stress) and mediated by psychosocial risk factors (anxiety, depression; health, financial and social concerns). METHODS: 1,043 cancer survivors receiving care at Northwestern Medicine completed a cross-sectional survey on COVID-19 practical and psychosocial concerns from 6/2021 to 3/2022. Participants reported on 21 adverse COVID-19 experiences (e.g., COVID-19 hospitalization, death of family/friends, loss of income, medical delays). The survey assessed 9 psychosocial factors related to COVID-19: anxiety, depression; health care, financial, and social disruptions; health care satisfaction; social support, perceived benefits, and stress management skills. The FACT-G7 assessed HRQoL. Hypotheses were tested in a structural equation model. The number of reported adverse COVID-19 experiences was the primary (observed) independent variable. The dependent variable of HRQoL, and the proposed mediating and moderating factors, were entered as latent variables indicated by their respective survey items. Latent interaction terms between the independent variable and each resiliency factor tested moderation effects. Analyses were adjusted for demographic and COVID-specific variables. RESULTS: Participants were, on average, aged 58 years and diagnosed with cancer 4.9 years prior. They were majority female (73.3%), White (89.6%), non-Hispanic/Latino (94.5%), college-educated (81.7%), and vaccinated for COVID-19 (95.5%). An average of 3.8 adverse COVID-19 experiences were reported. Results of structural equation modeling demonstrated that the association between adverse COVID-19 experiences and HRQoL was explained by indirect effects through COVID-19-related depression (ß = - 0.10, percentile bootstrap 95% CI - 0.15 to - 0.07) and financial concerns (ß = - 0.04, percentile bootstrap 95% CI - 0.07 to - 0.01). Hypotheses testing moderation by resiliency factors were not significant. CONCLUSIONS: Adverse COVID-19 experiences were associated with higher depression symptoms and financial concerns about COVID-19, and in turn, worse HRQoL. Oncology clinics should be cognizant of the experience of adverse COVID-19 events when allocating depression and financial support resources.

We conducted an online survey of cancer survivors receiving treatment at Northwestern Medicine in Chicago, Illinois. Participants responded to a list of 21 adverse experiences related to the pandemic, such as COVID-19 hospitalization, death of family/friends, loss of income, and medical delays. They also responded to questionnaires measuring their degree of anxiety, depression, daily disruptions, health disruptions, financial disruptions, social support, perceived benefits, and ability to manage stress during the pandemic. Lastly, they responded to a questionnaire on health-related quality of life, capturing their physical symptoms, emotional symptoms, and satisfaction with life. Our survey found that people who had a greater number of adverse COVID-19 experiences had higher levels of depression and financial burden, which in turn was associated with worse health-related quality of life.

Identifying meaningful change on PROMIS short forms in cancer patients: a comparison of item response theory and classic test theory frameworks.

BACKGROUND: This study compares classical test theory and item response theory frameworks to determine reliable change. Reliable change followed by anchoring to the change in categorically distinct responses on a criterion measure is a useful method to detect meaningful change on a target measure. METHODS: Adult cancer patients were recruited from five cancer centers. Baseline and follow-up assessments at 6 weeks were administered. We investigated short forms derived from PROMIS® item banks on anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance. We detected reliable change using reliable change index (RCI). We derived the T-scores corresponding to the RCI calculated under IRT and CTT frameworks using PROMIS® short forms. For changes that were reliable, meaningful change was identified using patient-reported change in PRO-CTCAE by at least one level. For both CTT and IRT approaches, we applied one-sided tests to detect reliable improvement or worsening using RCI. We compared the percentages of patients with reliable change and reliable/meaningful change. RESULTS: The amount of change in T score corresponding to RCICTT of 1.65 ranged from 5.1 to 9.2 depending on domains. The amount of change corresponding to RCIIRT of 1.65 varied across the score range, and the minimum change ranged from 3.0 to 8.2 depending on domains. Across domains, the RCICTT and RCIIRT classified 80% to 98% of the patients consistently. When there was disagreement, the RCIIRT tended to identify more patients as having reliably changed compared to RCICTT if scores at both timepoints were in the range of 43 to 78 in anxiety, 45 to 70 in depression, 38 to 80 in fatigue, 35 to 78 in sleep disturbance, and 48 to 74 in pain interference, due to smaller standard errors in these ranges using the IRT method. The CTT method found more changes compared to IRT for the pain intensity domain that was shorter in length. Using RCICTT, 22% to 66% had reliable change in either direction depending on domains, and among these patients, 62% to 83% had meaningful change. Using RCIIRT, 37% to 68% had reliable change in either direction, and among these patients, 62% to 81% had meaningful change. CONCLUSION: Applying the two-step criteria demonstrated in this study, we determined how much change is needed to declare reliable change at different levels of baseline scores. We offer reference values for percentage of patients who meaningfully change for investigators using the PROMIS instruments in oncology.

Patient-Reported Outcome Dashboards Within the Electronic Health Record to Support Shared Decision-making: Protocol for Co-design and Clinical Evaluation With Patients With Advanced Cancer and Chronic Kidney Disease.

BACKGROUND: Patient-reported outcomes-symptoms, treatment side effects, and health-related quality of life-are important to consider in chronic illness care. The increasing availability of health IT to collect patient-reported outcomes and integrate results within the electronic health record provides an unprecedented opportunity to support patients' symptom monitoring, shared decision-making, and effective use of the health care system. OBJECTIVE: The objectives of this study are to co-design a dashboard that displays patient-reported outcomes along with other clinical data (eg, laboratory tests, medications, and appointments) within an electronic health record and conduct a longitudinal demonstration trial to evaluate whether the dashboard is associated with improved shared decision-making and disease management outcomes. METHODS: Co-design teams comprising study investigators, patients with advanced cancer or chronic kidney disease, their care partners, and their clinicians will collaborate to develop the dashboard. Investigators will work with clinic staff to implement the co-designed dashboard for clinical testing during a demonstration trial. The primary outcome of the demonstration trial is whether the quality of shared decision-making increases from baseline to the 3-month follow-up. Secondary outcomes include longitudinal changes in satisfaction with care, self-efficacy in managing treatments and symptoms, health-related quality of life, and use of costly and potentially avoidable health care services. Implementation outcomes (ie, fidelity, appropriateness, acceptability, feasibility, reach, adoption, and sustainability) during the co-design process and demonstration trial will also be collected and summarized. RESULTS: The dashboard co-design process was completed in May 2020, and data collection for the demonstration trial is anticipated to be completed by the end of July 2022. The results will be disseminated in at least one manuscript per study objective. CONCLUSIONS: This protocol combines stakeholder engagement, health care coproduction frameworks, and health IT to develop a clinically feasible model of person-centered care delivery. The results will inform our current understanding of how best to integrate patient-reported outcome measures into clinical workflows to improve outcomes and reduce the burden of chronic disease on patients and health care systems. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38461.

A systematic review of pharmacologic treatment efficacy for depression in older patients with cancer.

Background: Older adults ≥65 years of age represent the majority of new cancer diagnoses and are vulnerable to developing depression-like symptoms. Evaluation and management of depression in older cancer patients is underappreciated despite its high prevalence and impact on health-related quality of life. Although antidepressants are the primary pharmacologics used to treat depressive-like symptoms, the efficacy and overall benefit(s) are not well-characterized in older adult patients with cancer. The objective of this investigation was to review what is known about the efficacy of pharmacologic treatment for older adults with depression and cancer. Methods: PubMed (Medline) and EMBASE (Elsevier) databases were analyzed for relevant literature in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: 1,919 unique studies were identified for title and abstract screening. Forty-eight publications were retrieved for full review. None of the identified studies evaluated the potential for benefit after pharmacological treatment among older adults with cancer and depression. Twenty-seven publications met all study criteria except for an analysis focused on older patients. Conclusion: We discovered a universal absence of literature with a relevance to pharmacologic antidepressant treatment effects in older adult patients with cancer. This included a lack of evaluation in patients with brain tumors who have an unusually high predilection for developing depression. Our findings suggest that new research is critically needed for understanding optimal clinical management strategies in older adults with cancer and depression who are treated with antidepressants.

Validation of the PROMIS sleep disturbance item bank computer adaptive test (CAT) in patients on renal replacement therapy.

OBJECTIVE: To examine the validity and reliability of the PROMIS Sleep Disturbance Item Bank Computer Adaptive Test (PROMIS-SD CAT) in patients on renal replacement therapy, using the Insomnia Severity Index as the primary legacy instrument. METHODS: Cross-sectional sample of adults on renal replacement therapy completed PROMIS-SD CAT, Insomnia Severity Index, General Anxiety Disorder-7, Edmonton Symptom Assessment System-revised Renal, SF-12 questionnaires. Construct validity was confirmed by associations with legacy instrument scores and measures of emotional wellbeing. Test-retest and scale reliability were assessed using intraclass correlation coefficient and standard errors of measurement, respectively. Discrimination was assessed using receiver-operating characteristic curve analysis. RESULTS: Among 217 participants (133 kidney transplant recipients, 84 on dialysis), 15% had moderate/severe sleep disturbance (Insomnia Severity Index ≥15). PROMIS-SD CAT exhibited good test-retest (intraclass correlation coefficient = 0.89, 95% confidence interval (0.83-0.93)) and scale (>0.9 for T-scores 34-73) reliability. PROMIS-SD CAT T-scores were strongly correlated with Insomnia Severity Index (rho = 0.85, 95% confidence interval (0.81-0.88)), Edmonton Symptom Assessment System-revised Renal Sleep Item (rho = 0.75, 95% confidence interval (0.69-0.81)) and moderately with General Anxiety Disorder-7 scores and SF-12 Mental Component Summary scores (p < 0.001 for all). PROMIS-SD CAT demonstrated outstanding discrimination for moderate/severe insomnia (defined as Insomnia Severity Index ≥15) (AUROC 0.93, 95% confidence interval (0.88, 0.98)). PROMIS-SD CAT and Insomnia Severity Index measurement characteristics were qualitatively similar between patients on dialysis and kidney transplant recipients. CONCLUSIONS: These results support PROMIS-SD CAT's validity and reliability for research and as potential screening tool among patients on renal replacement therapy.

Tolerability of bevacizumab and chemotherapy in a phase 3 clinical trial with human epidermal growth factor receptor 2-negative breast cancer: A trajectory analysis of adverse events.

BACKGROUND: E5103 was a study designed to evaluate the efficacy and safety of bevacizumab. It was a negative trial for the end points of invasive disease-free survival and overall survival. The current work examines the tolerability of bevacizumab and other medication exposures with respect to clinical outcomes and patient-reported outcomes (PROs). METHODS: Adverse events (AEs) collected from the Common Terminology Criteria for Adverse Events were summarized to form an AE profile at each treatment cycle. All-grade and high-grade events were separately analyzed. The change in the AE profile over the treatment cycle was delineated as distinct AE trajectory clusters. AE-related and any-reason early treatment discontinuations were treated as clinical outcome measures. PROs were measured with the Functional Assessment of Cancer Therapy-Breast + Lymphedema. The relationships between the AE trajectory and early treatment discontinuation as well as PROs were analyzed. RESULTS: More than half of all AEs (57.5%) were low-grade. A cluster of patients with broad and mixed AE (all-grade) trajectory grades was significantly associated with any-reason early treatment discontinuation (odds ratio [OR], 2.87; P = .01) as well as AE-related discontinuation (OR, 4.14; P = .001). This cluster had the highest count of all-grade AEs per cycle in comparison with other clusters. Another cluster of patients with primary neuropathic AEs in their trajectories had poorer physical well-being in comparison with a trajectory of no or few AEs (P < .01). A high-grade AE trajectory did not predict discontinuations. CONCLUSIONS: A sustained and cumulative burden of across-the-board toxicities, which were not necessarily all recognized as high-grade AEs, contributed to early treatment discontinuation. Patients with neuropathic all-grade AEs may require additional attention for preventing deterioration in their physical well-being.

A Low Literacy, Multimedia Health Information Technology Intervention to Enhance Patient-Centered Cancer Care in Safety Net Settings Increased Cancer Knowledge in a Randomized Controlled Trial.

We tested whether a low-literacy-friendly, multimedia information and assessment system used in daily clinical practice enhanced patient-centered care and improved patient outcomes. This was a prospective, parallel-group, randomized controlled trial with 2 arms, CancerHelp-Talking Touchscreen (CancerHelp-TT) versus control, among adults with Stage I-III breast or colorectal cancer receiving chemotherapy and/or radiation therapy in safety net settings. Each patient was assessed for outcomes at 4 timepoints: after starting treatment (baseline), during treatment, immediately after treatment, and at follow-up assessment. The primary outcomes were health beliefs, cancer knowledge, self-efficacy, and satisfaction with communication about cancer and its treatments. Health-related quality of life (HRQOL) was a secondary outcome. A total of 129 patients participated in the study (65 intervention and 64 control), and approximately 50% of these completed the study. Patients randomized to receive the CancerHelp-TT program had a significantly larger increase in their cancer knowledge in comparison to those randomized to the control arm (effect size = .48, P = .05). While effect sizes for differences between randomized groups in self-efficacy, health beliefs, HRQOL, and satisfaction with communication were small (.10-.48), there was a consistent trend that participants in the intervention group showed larger increases over time in all outcomes compared to the control group. The CancerHelp-TT software was favorably rated by intervention participants. The CancerHelp-TT program showed promise to increase vulnerable cancer patients' cancer knowledge and adaptive health beliefs and attitudes. However, vulnerable patients may need additional interventional support in settings outside cancer clinics.

Your Path to Transplant: A randomized controlled trial of a tailored expert system intervention to increase knowledge, attitudes, and pursuit of kidney transplant.

Individually tailoring education over time may help more patients, especially racial/ethnic minorities, get waitlisted and pursue deceased and living donor kidney transplant (DDKT and LDKT, respectively). We enrolled 802 patients pursuing transplant evaluation at the University of California, Los Angeles Transplant Program into a randomized education trial. We compared the effectiveness of Your Path to Transplant (YPT), an individually tailored coaching and education program delivered at 4 time points, with standard of care (SOC) education on improving readiness to pursue DDKT and LDKT, transplant knowledge, taking 15 small transplant-related actions, and pursuing transplant (waitlisting or LDKT rates) over 8 months. Survey outcomes were collected prior to evaluation and at 4 and 8 months. Time to waitlisting or LDKT was assessed with at least 18 months of follow-up. At 8 months, compared to SOC, the YPT group demonstrated increased LDKT readiness (47% vs 33%, P = .003) and transplant knowledge (effect size [ES] = 0.41, P < .001). Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002). A focused, coordinated education effort can improve transplant-seeking behaviors and waitlisting rates. ClinicalTrials.gov registration: NCT02181114.

Validation of a Brief Multi-Dimensional Assessment of Dementia Severity.

BACKGROUND/OBJECTIVES: Briefer measures of symptoms and functional limitations may reduce assessment burden and facilitate monitoring populations of persons with dementia (PWD). DESIGN: Prospective follow-up study. SETTING: University-based dementia care management program. PARTICIPANTS: 1,091 PWD. MEASUREMENTS: We assessed cognition (Mini Mental State Examination (MMSE)-11 tasks), neuropsychiatric symptom severity (Neuropsychiatric Inventory Questionnaire Severity Scale (NPIQ-S)-12 items), and functional ability (Activities of Daily Living (ADL)-6 items; Functional Activities Questionnaire (FAQ)-10 items). Item response theory was used to select subsets of items by identifying low item discrimination (<1.50), poor item fit (χ2 ), local dependence (LD), and with difficulty similar to other items. We estimated correlations between original and shorter scales and compared their associations with mortality. We added two symptoms (trouble swallowing, coughing when eating) reflecting late-stage dementia complications, created a multi-dimensional dementia assessment composite, and examined its association with mortality. RESULTS: Five MMSE tasks were eliminated: two with low discrimination, two with difficulty similar to other items, and one with poor fit. The remaining tasks were correlated with the full MMSE at r = 0.82. We retained three ADLs that were correlated with the total ADL set at r = 0.95 and kept five FAQ items that were not LD (correlation with full FAQ, r = 0.97). Associations with mortality were similar between the longer and shorter scales. A higher score on the composite (range 0-100) indicates worse dementia impact and was associated with mortality (hazard ratio (HR) per scale point: 1.03 (1.02-1.04)). CONCLUSION: These brief assessments and dementia composite may reduce administration time while preserving validity.

Survey of Clinician Opinions on Kidney Transplantation from Hepatitis C Virus Positive Donors: Identifying and Overcoming Barriers.

BACKGROUND: Transplant practices related to use of organs from Hepatitis C virus infected donors (DHCV+) is evolving rapidly. METHODS: We surveyed U.S. kidney transplant programs by email and professional society listserv postings between 7/19-1/20 to assess attitudes, management strategies, and barriers related to use of viremic (nucleic acid testing (NAT)+) donor organs in HCV uninfected recipients. RESULTS: Staff at 112 unique programs responded, representing 54% of U.S. adult kidney transplant programs and 69% of adult deceased donor kidney transplant volume in 2019. Most survey respondents were transplant nephrologists (46%) or surgeons (43%). Among responding programs, 67% currently transplant DHCV antibody+/NAT- organs under a clinical protocol or as standard of care. By comparison, only 58% offer DHCV NAT+ kidney transplant to HCV- recipients, including 35% under clinical protocols, 14% as standard of care, and 9% under research protocols. Following transplant of DHCV NAT+ organs to uninfected recipients, 53% start direct acting antiviral agent (DAA) therapy after discharge and documented viremia. Viral monitoring protocols after DHCV NAT+ to HCV uninfected recipient kidney transplantation varied substantially. 56% of programs performing these transplants report having an institutional plan to provide DAA treatment if declined by the recipient's insurance. Respondents felt a mean decrease in waiting time of ≥18 months (range 0-60) justifies the practice. Program concerns related to use of DHCV NAT+ kidneys include insurance coverage concerns (72%), cost (60%), and perceived risk of transmitting resistant infection (44%). CONCLUSIONS: Addressing knowledge about safety and logistical/financial barriers related to use of DHCV NAT+ kidney transplantation for HCV uninfected recipients may help reduced discards and expand the organ supply.

Amplifying the Patient Voice: Key Priorities and Opportunities for Improved Transplant and Living Donor Advocacy and Outcomes During COVID-19 and Beyond.

PURPOSE OF REVIEW: To define patient advocacy and engagement for modern transplant and living donation care, particularly in light of the COVID-19 pandemic, describe the patient experience when transplant advocacy and engagement are optimized, and recommend opportunities for advocacy within three key areas: (1) including the patient voice in healthcare decisions and drug development, (2) access to the best evidence-based treatments and informed decision-making, and (3) present and future care innovations and policies. RECENT FINDINGS: There are many avenues for transplant and living donation advocacy and engagement at the patient, provider, family, system, community, and policy levels. Key recommendations include the following: (1) simplifying education to be health literate, written at the appropriate reading level, culturally sensitive, and available in multiple languages and across many delivery platforms, (2) inviting transplant patients and donors to the conversation through advisory panels, consensus conferences, and new mediums like digital storytelling and patient-reported outcomes (PROs), (3) training all members of the health team to understand their role as advocates, and (4) advancing policies and programs that support the financial neutrality of living donation, and support recipients with the cost of immunosuppressive drugs. Key recommendations specific to the COVID-19 pandemic include providing up-to-date, health literate, concise information about preventing COVID-19 and accessing care including telehealth. SUMMARY: Enhancing advocacy and engagement for transplant patients and donors along the pre-to-post transplant/donation continuum can improve clinical outcomes and quality of life generally, and more so, in light of the COVID-19 pandemic.

Correction to: Trends and predictors of multidimensional health-related quality of life after living donor kidney transplantation.

In its original publication, an erroneous version of Fig. 2d was included in the manuscript. The corrected figure has now been added.

Trends and predictors of multidimensional health-related quality of life after living donor kidney transplantation.

PURPOSE: Living donor kidney transplant (LDKT) imparts the best graft and patient survival for most end-stage kidney disease (ESKD) patients. Yet, there remains variation in post-LDKT health-related quality of life (HRQOL). Improved understanding of post-LDKT HRQOL can help identify patients for interventions to maximize the benefit of LDKT. METHODS: For 477 LDKT recipients transplanted between 11/2007 and 08/2016, we assessed physical, mental, social, and kidney-targeted HRQOL pre-LDKT, as well as 3 and 12 months post-operatively using the SF-36, Kidney Disease Quality of Life-Short Form (KDQOL-SF), and the Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 item version (FKSI-19). We then examined trajectories of each HRQOL domain using latent growth curve models (LGCMs). We also examined associations between decline in HRQOL from 3 months to 12 months post-LDKT and death censored graft failure (DCGF) using Cox regression. RESULTS: Large magnitude effects (d > 0.80) were observed from pre- to post-LDKT change on the SF-36 Vitality scale (d = 0.81) and the KDQOL-SF Burden of Kidney Disease (d = 1.05). Older age and smaller pre- to post-LDKT decreases in serum creatinine were associated with smaller improvements on many HRQOL scales across all domains in LGCMs. Higher DCGF rates were associated with worse physical [e.g., SF-36 PCSoblique hazard ratio (HR) 1.18; 95% CI 1.01-1.38], mental (KDQOL-SF Cognitive Function HR 1.27; 95% CI 1.00-1.62), and kidney-targeted (FKSI-19 HR: 1.18; 95% CI 1.00-1.38) HRQOL domains. CONCLUSION: Clinical HRQOL monitoring may help identify patients who are most likely to have failing grafts and who would benefit from post-LDKT intervention.

Education Strategies in Dialysis Centers Associated With Increased Transplant Wait-listing Rates.

BACKGROUND: Transplant education in dialysis centers can increase access to kidney transplant; however, dialysis center transplant barriers are common, and limited research identifies the most effective transplant education approaches. METHODS: We surveyed transplant educators in 1694 US dialysis centers about their transplant knowledge, use of 12 education practices, and 8 identified education barriers. Transplant wait-listing rates were calculated using US Renal Data System data. RESULTS: Fifty-two percent of educators orally recommended transplant to patients, 31% had in-center transplant discussions with patients, 17% distributed print educational resources, and 3% used intensive education approaches. Distribution of print education (incident rate ratio: 1.021.151.30) and using >1 intensive education practice (1.001.111.23) within dialysis centers were associated with increased wait-listing rates. Several dialysis center characteristics were associated with reduced odds of using education strategies leading to increased wait-listing. Centers with greater percentages of uninsured patients (odds ratio [OR]: 0.960.970.99), in rural locations (OR: 0.660.790.95), with for-profit ownership (OR: 0.640.770.91), and with more patients older than 65 years (OR: 0.050.110.23) had lower odds of recommending transplant, while centers with a higher patient-to-staff ratio were more likely to do so (OR: 1.011.031.04). Language barriers (OR: 0.480.640.86) and having competing work priorities (OR: 0.400.530.70) reduced the odds of distributing print education. Providers with greater transplant knowledge were more likely to use >1 intensive educational strategy (OR: 1.011.271.60) while providers who reported competing work priorities (OR: 0.510.660.84) and poor communication with transplant centers (OR: 0.580.760.98) were less likely to do so. CONCLUSIONS: Educators should prioritize transplant education strategies shown to be associated with increasing wait-listing rates.

Problems with analyses and interpretation of data in "use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States".

A recent article in the journal reported analyses of KDQOL-36™ survey data collected from 240,343 adults (330,412 surveys) dialyzed at a large dialysis organization in the United States during 2014-2016. The authors concluded that the KDQOL-36™ Symptoms and Problems of Kidney Disease scale had the highest mean score of the KDQOL-36™ scales. We note that this inference was erroneous because the scales are not scored on the same numeric scale. In addition, the authors found that responses to a general health perceptions item ("In general, would you say your health is excellent, very good, good, fair, or poor") was not significantly associated with any of the 5 KDQOL-36 scale scores. In contrast, we find significant and noteworthy correlations in two other datasets. These analytic issues call into question the accuracy and validity of the conclusions of this paper.

Development and Validation of a Socioeconomic Kidney Transplant Derailers Index.

Socioeconomic barriers can prevent successful kidney transplant (KT) but are difficult to measure efficiently in clinical settings. We created and validated an individual-level, single score Kidney Transplant Derailers Index (KTDI) and assessed its association with waitlisting and living donor KT (LDKT) rates. METHODS: The dataset included 733 patients presenting for KT evaluation in a transplant center in California. Exploratory factor analysis was used to identify socioeconomic barriers to KT (derailers) to include in the index. Potential KT derailers included health insurance, employment, financial insecurity, educational attainment, perception of neighborhood safety, access to a vehicle, having a washer/dryer, and quality of social support. Validity was tested with associations between KTDI scores and the following: (1) the Area Deprivation Index (ADI) and (2) time to KT waitlisting and LDKT. RESULTS: Nine derailers were retained, omitting only social support level from the original set. The KTDI was scored by summing the number of derailers endorsed (mean: 3.0; range: 0-9). Black patients had higher estimated KTDI scores than other patient groups (versus White patients, 3.8 versus 2.1; P < 0.001, effect size = 0.81). In addition, the KTDI was associated with the ADI (γ = 0.70, SE = 0.07; P < 0.001). Finally, in comparison to the lower tertile, patients in the upper and middle KTDI tertiles had lower hazard of waitlisting (upper tertile hazard ratio [HR]: 0.34, 95% confidence interval [CI]: 0.25-0.45; middle tertile HR: 0.54, 95% CI: 0.40-0.72) and receiving an LDKT (upper tertile HR: 0.15, 95% CI: 0.08-0.30; middle tertile HR: 0.35, 95% CI: 0.20-0.62). These associations remained significant when adjusting for the ADI and other patient characteristics. CONCLUSIONS: The KTDI is a valid indicator of socioeconomic barriers to KT for individual patients that can be used to identify patients at risk for not receiving a KT.

Impaired cognition predicts the risk of hospitalization and death in cirrhosis.

OBJECTIVE: Cognitive impairment, detected in up to 80% of patients with liver cirrhosis, is associated with negative health outcomes but is underdiagnosed in the clinical setting due to the lack of practical testing method. This single-center prospective observational study aimed to test the feasibility and prognostic utility of in-clinic cognitive assessment of patients with liver cirrhosis using the NIH Toolbox cognition battery (NIHTB). METHODS: Patients recruited from a hepatology/transplant clinic underwent cognitive assessments using West-Haven Grade (WHG) and NIHTB between November 2016 and August 2018 and were prospectively followed until December 2018. The primary outcome was a composite end point of hospitalization related to overt hepatic encephalopathy (OHE) and all-cause mortality during follow-up, evaluated by a Cox proportional hazards regression model that adjusted for a priori covariates (age and MELD-Na). RESULTS: Among 127 patients (median age 60 years, 48 [38%] women) assessed, cognitive performance was significantly impaired in 82 [78%] patients with WHG 0 and 22 [100%] patients with WHG 1 and 2. Over a median of 347 days follow-up, 18 OHE and 8 deaths were observed. Lower cognitive performance was associated with an increased risk of OHE/death adjusting for age and MELD-Na. Subclinical cognitive impairment detected by NIH Toolbox in WHG 0 patients was significantly associated with greater mortality. Median time to complete the two prognostically informative NIH Toolbox tests was 9.4 min. INTERPRETATION: NIH Toolbox may enable a rapid cognitive screening in the outpatient setting and identify patients at high risk for death and hospitalization for severe encephalopathy.

Differential item functioning of the CAHPS® In-Center Hemodialysis Survey.

PURPOSE: End-stage renal disease patients' experience of care is an integral part of the assessment of the quality of the care provided at hemodialysis centers and is needed to promote patient choice, quality improvement, and accountability. The purpose of this study is to evaluate the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH-CAHPS®) survey and its equivalence in different age, gender, race, and education subgroups. METHODS: The ICH-CAHPS survey was administered to 1454 patients from 32 dialysis facilities. For the characteristics compared, the sample had 756 participants younger than 65 years old, 739 men, 516 Black, 567 White, and 970 with less than high school diploma. Three different patient experience constructs were studied including nephrologist's communication and caring, quality of care and operations, and providing information to patients. We used item response theory analysis to examine the possibility of differential item functioning (DIF) by patient age, gender, race, and education separately after controlling for the other DIF characteristics and additional confounding variables including survey mode, mental, and general health status as well as duration on dialysis. RESULTS: The three constructs studied were unidimensional and no major DIF was observed on the composites. Some non-equivalences were observed when confounders were not controlled for, suggesting that such covariates can be important factors in understanding the possibility of disparity in patients' experience. CONCLUSIONS: The ICH-CAHPS is a promising survey to elicit hemodialysis patients' experience that has good psychometric properties and provides a standardized tool for assessing age, gender, race, or education disparity.