Co-design and usability of an interactive web-based fertility decision aid for transgender youth and young adults.

OBJECTIVE: To develop a patient- and family-centered Aid For Fertility-Related Medical Decisions (AFFRMED) interactive website targeted for transgender and nonbinary (TNB) youth/young adults and their parents to facilitate shared decision-making about fertility preservation interventions through user-centered participatory design. METHOD: TNB youth/young adults interested in or currently receiving pubertal suppression or gender-affirming hormone treatment and parents of eligible TNB youth/young adults were recruited to participate in a series of iterative human-centered co-design sessions to develop an initial AFFRMED prototype. Subsequently, TNB youth/young adults and parents of TNB youth/young adults were recruited for usability testing interviews, involving measures of usability (i.e., After Scenario Questionnaire, Net Promotor Score, System Usability Scale). RESULTS: Twenty-seven participants completed 18 iterative co-design sessions and provided feedback on 10 versions of AFFRMED (16 TNB youth/young adults and 11 parents). Nine TNB youth/young adults and six parents completed individual usability testing interviews. Overall, participants rated AFFRMED highly on measures of acceptability, appropriateness, usability, and satisfaction. However, scores varied by treatment cohort, with TNB youth interested in or currently receiving pubertal suppression treatment reporting the lowest usability scores. CONCLUSIONS: We co-created a youth- and family-centered fertility decision aid prototype that provides education and decision support in an online, interactive format. Future directions include testing the efficacy of the decision aid in improving fertility and fertility preservation knowledge, decisional self-efficacy, and decision satisfaction.

Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease : A Randomized Controlled Trial.

BACKGROUND: Older patients with advanced chronic kidney disease (CKD) face difficult decisions about managing kidney failure, frequently experiencing decisional conflict, regret, and treatment misaligned with preferences. OBJECTIVE: To assess whether a decision aid about kidney replacement therapy improved decisional quality compared with usual care. DESIGN: Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT03522740). SETTING: 8 outpatient nephrology clinics associated with 4 U.S. centers. PARTICIPANTS: English-fluent patients, 70 years and older with nondialysis CKD stages 4 to 5 recruited from 2018 to 2020. INTERVENTION: DART (Decision-Aid for Renal Therapy) is an interactive, web-based decision aid for older adults with CKD. Both groups received written education about treatments. MEASUREMENTS: Change in the decisional conflict scale (DCS) score from baseline to 3, 6, 12, and 18 months. Secondary outcomes included change in prognostic and treatment knowledge and change in uncertainty. RESULTS: Among 400 participants, 363 were randomly assigned: 180 to usual care, 183 to DART. Decisional quality improved with DART with mean DCS declining compared with control (mean difference, -8.5 [95% CI, -12.0 to -5.0]; P < 0.001), with similar findings at 6 months, attenuating thereafter. At 3 months, knowledge improved with DART versus usual care (mean difference, 7.2 [CI, 3.7 to 10.7]; P < 0.001); similar findings at 6 months were modestly attenuated at 18 months (mean difference, 5.9 [CI, 1.4 to 10.3]; P = 0.010). Treatment preferences changed from 58% "unsure" at baseline to 28%, 20%, 23%, and 14% at 3, 6, 12, and 18 months, respectively, with DART, versus 51% to 38%, 35%, 32%, and 18% with usual care. LIMITATION: Latinx patients were underrepresented. CONCLUSION: DART improved decision quality and clarified treatment preferences among older adults with advanced CKD for 6 months after the DART intervention. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute (PCORI).

Social work collective leadership in a large urban hospital during an era of unprecedented transformational change.

This Department of Social Work Services (the Department) is one of the largest hospital social work departments in the country, with almost 600 staff, in the largest of eight hospitals and one medical school of a major health system. The Department's senior directors (three current and one former) share its innovative and effective collective leadership model that was initially developed in response to a confluence of unprecedented complex events stemming from the Covid-19 pandemic. The experiences of these co-leaders, an evaluation of the model, future internal considerations as its applicability to other health care settings will be discussed.

Living uterus donors' perceptions of decision-making and informed consent: a qualitative study of the Dallas Uterus Transplant Study participants.

Uterus transplantation is a growing field, but little is known about living uterus donors' perceptions of informed consent or their decision-making processes. This study used semistructured interviews to collect information regarding uterus donors' experiences with uterus donation, perceptions of the informed consent process, and information on how they decided to pursue uterus donation. Interviews were coded for thematic analysis. Three major themes emerged in this study. First, the decision-making process was based on individuals' motivations, rationale, and considerations of alternative contributions to help other women with infertility. Second, participants described how they felt about the process of informed consent, their decision-making processes, and how their experiences compared with their expectations. Third, participants discussed how uterus donation was a valuable experience. This study found that living uterus donors are motivated to give another woman the opportunity to experience pregnancy and childbirth. They were satisfied with the informed consent process, their experiences were in line with their expectations, and the value of uterus donation was associated with the act of donation itself. Our findings suggest that living donor uterus programs should develop robust informed consent processes that provide detailed information about uterus donation and encourage shared decision-making with potential uterus donors.

Development and Validation of the Rating of CKD Knowledge Among Older Adults (Know-CKD) With Kidney Failure.

RATIONALE & OBJECTIVE: Few older adults with kidney failure engage in shared decision making (SDM) for kidney replacement therapy. The lack of instruments to assess SDM-relevant knowledge domains may contribute to this. We assessed the reliability and validity of a new instrument, the Rating of CKD Knowledge Older Adults (Know-CKD). STUDY DESIGN: Multistage process, including a stakeholder-engaged development phase, pilot testing, and validation of a knowledge instrument using a cross-sectional survey of older adults with CKD. SETTING & PARTICIPANTS: 363 patients aged 70+years with nondialysis advanced chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR]<30mL/min/1.73m2) in Boston, Chicago, Portland, ME, and San Diego from June 2018 and January 2020. EXPOSURE: Educational level, higher literacy (Single Item Literacy Screener [SILS]) and numeracy (Subjective Numeracy Scale [SNS]), having participated in clinic-sponsored dialysis education, and self-reported "feeling informed" about options for treatment. OUTCOME: Validity and reliability of the Know-CKD instrument. ANALYTICAL APPROACH: Reliability was assessed with the Kuder-Richardson-20 coefficient. Construct validity was demonstrated by testing a priori hypotheses using t test, analysis of variance (ANOVA) tests, and linear regression analyses. RESULTS: The mean (± SD) participant age was 77.6±5.9 years, and mean eGFR was 22.7±7.2mL/min/1.73m2; 281 participants (78%) self-reported as White. The 12-item Know-CKD assessment had good reliability (Kuder-Richardson-20 reliability coefficient=0.75), and a mean score of 58.2% ± 22.3 SD. The subscales did not attain acceptable reliability. The proportion answering correctly on each item ranged from 20.1% to 91.7%. In examining construct validity, the hypothesized associations held; Know-CKD significantly associated with higher education (ß=6.98 [95% CI, 1.34-12.61], P=0.02), health literacy (ß = -12.67 [95% CI, -19.49 to-5.86], P≤0.001), numeracy per 10% higher (ß=1.85 [95% CI, 1.02-2.69], P≤0.001), and attendance at dialysis class (ß=18.28 [95% CI, 13.30-23.27], P≤0.001). These associations were also observed for the subscales except for prognosis (not associated with literacy or numeracy). LIMITATIONS: Know-CKD is only available in English and has been used only in research settings. CONCLUSIONS: For older adults facing dialysis initiation decisions, Know-CKD is a valid, reliable, and easy to administer measure of knowledge. Further research should examine the relationship of kidney disease knowledge and SDM, patient satisfaction, and clinical outcomes. PLAIN-LANGUAGE SUMMARY: The Rating of CKD Knowledge Among Older Adults (Know-CKD) study measures knowledge of chronic kidney disease (CKD) and is designed for older adults. Most existing knowledge measures for CKD focus on people of all ages and all CKD stages. This measure is useful because it will allow researchers to assess how well patient education efforts are working. Patient education is a way to help patients make decisions about their care. We describe how the measure was developed by a team of doctors, researchers, and patients, and how the measure performed among persons with advanced CKD aged 70 years and older. Know-CKD can inform efforts to improve shared decision-making research and practice for older patients with kidney disease.

Prospective associations of health literacy with clinical outcomes in adults with CKD: findings from the CRIC study.

BACKGROUND: Limited health literacy is associated with significant morbidity and mortality in the general population but the relation of health literacy with long-term clinical outcomes among adults with chronic kidney disease (CKD) is less clear. METHODS: Prospective data from the Chronic Renal Insufficiency Cohort (CRIC) Study (n = 3715) were used. Health literacy was assessed with the Short Test of Functional Health Literacy in Adults (dichotomized as limited/adequate). Cox proportional hazards models were used to separately examine the relations of health literacy with CKD progression, cardiovascular event (any of the following: myocardial infarction, congestive heart failure, stroke or peripheral artery disease), and all-cause, cardiovascular and non-cardiovascular mortality. Poisson regression was used to assess the health literacy-hospitalization association. Models were sequentially adjusted: Model 1 adjusted for potential confounders (sociodemographic factors), while Model 2 additionally adjusted for potential mediators (clinical and lifestyle factors) of the associations of interest. RESULTS: In confounder-adjusted models, participants with limited (vs adequate) health literacy [555 (15%)] had an increased risk of CKD progression [hazard ratio (HR) 1.34; 95% confidence interval (CI) 1.06-1.71], cardiovascular event (HR 1.67; 95% CI 1.39-2.00), hospitalization (rate ratio 1.33; 95% CI 1.26-1.40), and all-cause (HR 1.54; 95% CI 1.27-1.86), cardiovascular (HR 2.39; 95% CI 1.69-3.38) and non-cardiovascular (HR 1.27; 95% CI 1.01-1.60) mortality. Additional adjustments for potential mediators (Model 2) showed similar results except that the relations of health literacy with CKD progression and non-cardiovascular mortality were no longer statistically significant. CONCLUSIONS: In the CRIC Study, adults with limited (vs adequate) health literacy had a higher risk for CKD progression, cardiovascular event, hospitalization and mortality-regardless of adjustment for potential confounders.

A viewpoint describing the American Society of Transplantation rationale to conduct a comprehensive patient survey assessing unmet immunosuppressive therapy needs.

This viewpoint aims to "set the stage" and provide the rationale for the proposed development of a large-scale, comprehensive survey assessing transplant patients' perceived unmet immunosuppressive therapy needs. Research in organ transplantation has historically focused on reducing the incidence and impact of rejection on allograft survival and minimizing or eliminating the need for chronic immunosuppressive therapies. There has been less emphasis and investment in therapies to improve patient-reported outcomes including health-related quality of life and side-effects. Patient-focused drug development (PFDD) is a new and important emphasis of the Food and Drug Administration (FDA) that provides a guiding philosophy for incorporating the patient experience into drug development and evaluation. The American Society of Transplantation (AST) Board of Directors commissioned this working group to prepare for the conduct of a comprehensive patient survey assessing unmet immunosuppressive therapy needs. This paper aims to describe the basis for why it is important to conduct this survey and briefly outline the plan for broad stakeholder engagement to ensure the information gained is diverse, inclusive, and relevant for advancing PFDD in organ transplant recipients.

Financial, policy, and ethical barriers to the expansion of living donor liver transplant: Meeting report from a living donor liver transplant consensus conference.

INTRODUCTION: In October 2021, the American Society of Transplantation (AST) hosted a virtual consensus conference aimed at identifying and addressing barriers to the broader, safe expansion of living donor liver transplantation (LDLT) throughout the United States (US). METHODS: A multidisciplinary group of LDLT experts convened to address issues related to financial implications on the donor, transplant center crisis management, regulatory and oversight policies, and ethical considerations by assessing the relative significance of issues in preventing LDLT growth, with proposed strategies to overcome barriers. RESULTS: Living liver donors endure multiple obstacles including financial instability, loss of job security, and potential morbidity. These concerns, along with other center, state, and federal specific policies can be perceived as significant barriers to expanding LDLT. Donor safety is of paramount importance to the transplant community; however, regulatory and oversight policies aimed at ensuring donor safety can be viewed as ambiguous and complicated leading to time-consuming evaluations that may deter donor motivation and program expansion. CONCLUSION: Transplant programs need to establish appropriate crisis management plans to mitigate potential negative donor outcomes and ensure program viability and stability. Finally, ethical aspects, including informed consent for high-risk recipients and use of non-directed donors, can be perceived as additional barriers to expanding LDLT.

Ethical analysis examining the prioritisation of living donor transplantation in times of healthcare rationing.

The transplant community has faced unprecedented challenges balancing risks of performing living donor transplants during the COVID-19 pandemic with harms of temporarily suspending these procedures. Decisions regarding postponement of living donation stem from its designation as an elective procedure, this despite that the Centers for Medicare and Medicaid Services categorise transplant procedures as tier 3b (high medical urgency-do not postpone). In times of severe resource constraints, health systems may be operating under crisis or contingency standards of care. In this manuscript, the United Network for Organ Sharing Ethics Workgroup explores prioritisation of living donation where health systems operate under contingency standards of care and provide a framework with recommendations to the transplant community on how to approach living donation in these circumstances.To guide the transplant community in future decisions, this analysis suggests that: (1) living donor transplants represent an important option for individuals with end-stage liver and kidney disease and should not be suspended uniformly under contingency standards, (2) exposure risk to SARS-CoV-2 should be balanced with other risks, such as exposure risks at dialysis centres. Because many of these risks are not quantifiable, donors and recipients should be included in discussions on what constitutes acceptable risk, (3) transplant hospitals should strive to maintain a critical transplant workforce and avoid diverting expertise, which could negatively impact patient preparedness for transplant, (4) transplant hospitals should consider implementing protocols to ensure early detection of SARS-CoV-2 infections and discuss these measures with donors and recipients in a process of shared decision-making.

Direct and Indirect Effects of a Web-Based Educational and Communication Skills Intervention "Promotoras de Donación" to Increase Donor Designation in Latinx Communities: Evaluation Study.

BACKGROUND: Latinx populations are severely underrepresented among organ donors compared with the non-Hispanic White population. The Promotoras de Donación e-learning module was developed to train Latinx lay health educators (ie, promotoras) to discuss deceased organ donation and promote donor designation within their communities. OBJECTIVE: This paper described the results of 2 studies designed to assess the direct and indirect effects of the module on promotoras' and mature Latinas' organ donation and donor designation knowledge, attitudes, and behaviors. METHODS: In partnership with 4 community-based promotoras organizations, we designed 2 nonrandomized, quasiexperimental pragmatic studies to evaluate the Promotoras de Donación e-learning module, with participating promotoras and mature Latinas serving as their own controls. Brief surveys were administered to participating promotoras before and after module completion to assess changes in organ donation knowledge and support and communication confidence (study 1). Promotoras participating in the first study were asked to hold at least 2 group conversations about organ donation and donor designation with mature Latinas (study 2); paper-pencil surveys were completed by all participants before and after the group conversations. Descriptive statistics, means and SDs, and counts and percentages were used as appropriate to categorize the samples. Paired sample 2-tailed t test was used to assess changes in knowledge of and support for organ donation and confidence in discussing donation and promoting donor designation from pre- to posttest. RESULTS: Overall, 40 promotoras completed this module (study 1). Increases in organ donation knowledge (mean 6.0, SD 1.9 to mean 6.2, SD 2.9) and support (mean 3.4, SD 0.9 to mean 3.6, SD 0.9) were observed from pre- to posttest; however, these changes did not reach statistical significance. A statistically significant increase in communication confidence was found (mean 692.1, SD 232.4 to mean 852.3, SD 139.7; P=.01). The module was well received, with most participants deeming it well organized, presenting new information, and providing realistic and helpful portrayals of donation conversations. A total of 52 group discussions with 375 attendees were led by 25 promotoras (study 2). The trained promotora-led group discussions about organ donation resulted in increased support for organ donation in promotoras and mature Latinas from pre- to posttest. Knowledge of the steps to become an organ donor and belief that the process is easy to perform increased in mature Latinas from pre- to posttest by 30.7% and 15.2%, respectively. In total, 5.6% (21/375) of attendees submitted completed organ donation registration forms. CONCLUSIONS: This evaluation provides preliminary support for the module's direct and indirect effects on organ donation knowledge, attitudes, and behaviors. The need for additional modifications to and future evaluations of the module are discussed.

The ethics of donation after circulatory death organ recovery: an overview of new considerations arising from procurement practice and policy changes.

PURPOSE OF REVIEW: The aim of this study is to examine ethical issues raised by organ recovery from donors after circulatory death (DCD). RECENT FINDINGS: Recent technological developments and policy modifications have implications for evolving ethical issues related to DCD organ procurement and donation. We identify four such changes and discuss the most significant ethical issues raised by each: the use of cardiac perfusion machines and the need to develop criteria to allow prioritization for organ preservation in joint thoracic-abdominal procurements, normothermic regional perfusion and the irreversibility criterion in the definition of death, practice variability in DCD withdrawal of care and death declarations, and equitable access to donation, and changes in organ procurement organization evaluation metrics and transplant system resource utilization. SUMMARY: The evolution of DCD donation raises new ethical concerns that require further analysis to ensure that deceased donors, donor families and transplant recipients are treated respectfully and equitably.

Impact of having potential living donors on ethnic/racial disparities in access to kidney transplantation.

Racial/ethnic disparities persist in patients' access to living donor kidney transplantation (LDKT). This study assessed the impact of having available potential living donors (PLDs) on candidates' receipt of a kidney transplant (KT) and LDKT at two KT programs. Using data from our clinical trial of waitlisted candidates (January 1, 2014-December 31, 2019), we evaluated Hispanic and Non-Hispanic White (NHW) KT candidates' number of PLDs. Multivariable logistic regression assessed the impact of PLDs on transplantation (KT vs. no KT; for KT recipients, LDKT vs. deceased donor KT). A total of 847 candidates were included, identifying as Hispanic (45.8%) or NHW (54.2%). For Site A, both Hispanic (adjusted OR = 2.26 [95% CI 1.13-4.53]) and NHW (OR = 2.42 [1.10-5.33]) candidates with PLDs completing the questionnaire were more likely to receive a KT. For Site B, candidates with PLDs were not significantly more likely to receive KT. Among KT recipients at both sites, Hispanic (Site A: OR = 21.22 [2.44-184.88]; Site B: OR = 25.54 [7.52-101.54]), and NHW (Site A: OR = 37.70 [6.59-215.67]; Site B: OR = 15.18 [5.64-40.85]) recipients with PLD(s) were significantly more likely to receive a LDKT. Our findings suggest that PLDs increased candidates' likelihood of KT receipt, particularly LDKT. Transplant programs should help candidates identify PLDs early in transplant evaluation.

Effectiveness of a culturally competent care intervention in reducing disparities in Hispanic live donor kidney transplantation: A hybrid trial.

Hispanic patients receive disproportionately fewer living donor kidney transplants (LDKTs) than non-Hispanic Whites (NHWs). The Northwestern Medicine Hispanic Kidney Transplant Program (HKTP), designed to increase Hispanic LDKTs, was evaluated as a nonrandomized, implementation-effectiveness hybrid trial of patients initiating transplant evaluation at two intervention and two similar control sites. Using a mixed method, observational design, we evaluated the fidelity of the HKTP implementation at the two intervention sites. We tested the impact of the HKTP intervention by evaluating the likelihood of receiving LDKT comparing pre-intervention (January 2011-December 2016) and postintervention (January 2017-March 2020), across ethnicity and centers. The HKTP study included 2063 recipients. Intervention Site A exhibited greater implementation fidelity than intervention Site B. For Hispanic recipients at Site A, the likelihood of receiving LDKTs was significantly higher at postintervention compared with pre-intervention (odds ratio [OR] = 3.17 95% confidence interval [1.04, 9.63]), but not at the paired control Site C (OR = 1.02 [0.61, 1.71]). For Hispanic recipients at Site B, the likelihood of receiving an LDKT did not differ between pre- and postintervention (OR = 0.88 [0.40, 1.94]). The LDKT rate was significantly lower for Hispanics at paired control Site D (OR = 0.45 [0.28, 0.90]). The intervention significantly improved LDKT rates for Hispanic patients at the intervention site that implemented the intervention with greater fidelity. Registration: ClinicalTrials.gov registered (retrospectively) on September 7, 2017 (NCT03276390).

The Association of Health Literacy with Health-Related Quality of Life in Youth and Young Adults with Spina Bifida: A Cross-Sectional Study.

OBJECTIVE: The objective of the study was to determine if health literacy is associated with health-related quality of life (HRQOL) in adolescents and young adults (AYAs) with spina bifida. STUDY DESIGN: Between June 2019 and March 2020, the Patient-Reported Outcome Measurement Information System Pediatric Global Health-7 (PGH-7), a measure of HRQOL, and the Brief Health Literacy Screening Tool (BRIEF) were administered to patients ≥12 years old with a diagnosis of spina bifida seen in our multidisciplinary spina bifida center. Questionnaires were completed at scheduled clinic visits. The primary outcome was the PGH-7 normalized T-score. The primary exposure was the BRIEF score. Demographic and clinical characteristics were obtained from the medical record. Nested, multivariable linear regression models assessed the association between health literacy and the PGH-7 score. RESULTS: Of 232 eligible patients who presented to clinic, 226 (97.4%) met inclusion criteria for this study. The median age was 17.0 years (range: 12-31). Most individuals were female (54.0%) and had myelomeningocele (61.5%). Inadequate, marginal, and adequate health literacy levels were reported by 35.0%, 28.3%, and 36.7% of individuals. In univariable analysis, higher health literacy levels were associated with higher PGH-7 scores. In nested, sequentially adjusted multivariable linear regression models, a higher health literacy level was associated with a stepwise increase in the PGH-7 score. In the fully adjusted model, adequate health literacy and marginal health literacy, compared with inadequate health literacy, were associated with increases in a PGH-7 score of 3.3 (95% CI: 0.2-6.3) and 1.1 (95% CI: -2.0 to 4.2), respectively. CONCLUSIONS: Health literacy was associated with HRQOL after adjusting for demographic and clinical factors. Strategies incorporating health literacy are needed to improve HRQOL in AYAs with spina bifida.

Shared Decision Making Among Older Adults With Advanced CKD.

RATIONALE & OBJECTIVE: Older adults with advanced chronic kidney disease (CKD) face difficult decisions about dialysis initiation. Although shared decision making (SDM) can help align patient preferences and values with treatment options, the extent to which older patients with CKD experience SDM remains unknown. STUDY DESIGN: A cross-sectional analysis of patient surveys examining decisional readiness, treatment options education, care partner support, and SDM. SETTING & PARTICIPANTS: Adults aged 70 years or older from Boston, Chicago, San Diego, or Portland (Maine) with nondialysis advanced CKD. PREDICTORS: Decisional readiness factors, treatment options education, and care partner support. OUTCOMES: Primary: SDM measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9) instrument, with higher scores reflecting greater SDM. Exploratory: Factors associated with SDM. ANALYTICAL APPROACH: We used multivariable linear regression models to examine the associations between SDM and predictors, controlling for demographic and health factors. RESULTS: Among 350 participants, mean age was 78 ± 6 years, 58% were male, 13% identified as Black, and 48% had diabetes. Mean SDM-Q-9 score was 52 ± 28. SDM item agreement ranged from 41% of participants agreeing that "my doctor and I selected a treatment option together" to 73% agreeing that "my doctor told me that there are different options for treating my medical condition." In multivariable analysis adjusted for demographic characteristics, lower estimated glomerular filtration rate, and diabetes, being "well informed" and "very well informed" about kidney treatment options, having higher decisional certainty, and attendance at a kidney treatment options class were independently associated with higher SDM-Q-9 scores. LIMITATIONS: The cross-sectional study design limits the ability to make temporal associations between SDM and the predictors. CONCLUSIONS: Many older patients with CKD do not experience SDM when making dialysis decisions, emphasizing the need for greater access to and delivery of education for individuals with advanced CKD.

The journey from infertility to uterus transplantation: A qualitative study of the perspectives of participants in the Dallas Uterus Transplant Study.

OBJECTIVE: To assess how absolute uterine factor infertility affects women who undergo uterus transplantation, how uterus transplantation impacts women with absolute uterine factor infertility and how uterus transplant recipients view uterus transplantation in terms of their reproductive autonomy. DESIGN: Qualitative semi-structured interview study. SETTING: Uterus transplant programme in a large academic medical centre in the USA. POPULATION/SAMPLE: Twenty one uterus transplant recipients. METHODS: A medical chart review was conducted to collect patient demographic information and clinical outcomes. Semi-structured interviews collected information regarding participants' experience. MAIN OUTCOME MEASURE(S): The outcomes of interest were participants' experience of infertility, experience with uterus transplantation and general perceptions of uterus transplantation. RESULTS: Six participants were pregnant (one with a second child), six had experienced early graft failure and removal, five had delivered a healthy baby, and four had a viable graft and were awaiting embryo transfer. The primary themes identified were: the negative impact of absolute uterine factor infertility diagnosis on psychological wellbeing, relationships and female identity; the positive impact of uterus transplantation on healing the emotional scars of absolute uterine factor infertility, female identity and value of research trial participation and the perception of uterus transplantation as an expansion of reproductive autonomy. All participants reported that uterus transplantation was worthwhile, regardless of individual outcome. CONCLUSION: Absolute uterine factor infertility has a negative impact on women from a young age, affects multiple relationships and challenges female identity. Uterus transplantation helps to reverse this impact, transforming women's life narrative of infertility and enhancing female identity. TWEETABLE ABSTRACT: Absolute uterine factor infertility (AUFI) adversely affects women. Uterus transplantation helps mitigate the negative impact of AUFI, by transforming women's life narratives of infertility and enhancing female identity.

Public Perceptions and Information Needs of VCA Transplantation and Donation: A Mixed Methods Study.

Vascularized Composite Allotransplantation (VCA) involves transplantation of multiple tissues from a donor to a recipient (e.g., skin, muscle, bone). Little is known about the US public's perceptions of and attitudes toward VCA organ donation. This multi-site, cross-sectional, mixed methods study involved focus groups and surveys to assess members of the general public's attitudes about VCA, and willingness and barriers to donate VCA organs. Qualitative data were analyzed by thematic analysis; quantitative data were analyzed by descriptive statistics. In focus groups (n = 6, 42 participants), most participants were female (57%) and Black (62%) with mean age of 42.6 years. Three main themes emerged: 1) awareness and perceptions of VCA, 2) purpose of VCA donation, 3) and barriers to VCA donation. Participants had heard little about VCA and sought information about VCA donation. Participants perceived VCA as challenging their concepts of "normality" and voiced concerns that VCA would create "Frankenstein[s]." Barriers to VCA donation included disruptions to end-of-life arrangements and information gaps regarding the donation process. Participants reported moderate to high willingness to donate their hands (69%) and face (50%) Public education efforts should address the specific needs and concerns of the public to facilitate VCA donation and family authorization.

Defining the ethical considerations surrounding kidney transplantation for frail and cognitively impaired patients: a Delphi study of geriatric transplant experts.

BACKGROUND: Among adult kidney transplant (KT) candidates, 21% are frail and 55% have cognitive impairment, increasing the risk of pre- and post-KT mortality. Centers often assess frailty status and cognitive function during transplant evaluation to help identify appropriate candidate. Yet, there are no ethical guidelines regarding the use of frailty and cognitive function during this evaluation. We seek to develop a clinical consensus on balancing utility and justice in access to KT for frail and cognitively impaired patients. METHODS: Twenty-seven experts caring for ESRD patients completed a two-round Delphi panel designed to facilitate consensus (> 80% agreement). RESULTS: Experts believed that denying patients transplantation based solely on expected patient survival was inequitable to frail or cognitively impaired candidates; 100% agreed that frailty and cognitive impairment are important factors to consider during KT evaluation. There was consensus that health related quality of life and social support are important to consider before waitlisting frail or cognitively impaired patients. Experts identified important factors to consider before waitlisting frail (likely to benefit from KT, frailty reversibility, age, and medical contraindications) and cognitively impaired (degree of impairment and medication adherence) patients. CONCLUSIONS: Clinical experts believed it was ethically unacceptable to allocate organs solely based on patients' expected survival; frailty and cognitive impairment should be measured at evaluation when weighed against other clinical factors. Ethical guidelines regarding the use of frailty and cognitive function during KT evaluation ought to be developed.

Advance Care Planning in Older Adults with CKD: Patient, Care Partner, and Clinician Perspectives.

BACKGROUND: Older patients with advanced CKD are at high risk for serious complications and death, yet few discuss advance care planning (ACP) with their kidney clinicians. Examining barriers and facilitators to ACP among such patients might help identify patient-centered opportunities for improvement. METHODS: In semistructured interviews in March through August 2019 with purposively sampled patients (aged ≥70 years, CKD stages 4-5, nondialysis), care partners, and clinicians at clinics in across the United States, participants described discussions, factors contributing to ACP completion or avoidance, and perceived value of ACP. We used thematic analysis to analyze data. RESULTS: We conducted 68 semistructured interviews with 23 patients, 19 care partners, and 26 clinicians. Only seven of 26 (27%) clinicians routinely discussed ACP. About half of the patients had documented ACP, mostly outside the health care system. We found divergent ACP definitions and perspectives; kidney clinicians largely defined ACP as completion of formal documentation, whereas patients viewed it more holistically, wanting discussions about goals, prognosis, and disease trajectory. Clinicians avoided ACP with patients from minority groups, perceiving cultural or religious barriers. Four themes and subthemes informing variation in decisions to discuss ACP and approaches emerged: (1) role ambiguity and responsibility for ACP, (2) questioning the value of ACP, (3) confronting institutional barriers (time, training, reimbursement, and the electronic medical record, EMR), and (4) consequences of avoiding ACP (disparities in ACP access and overconfidence that patients' wishes are known). CONCLUSIONS: Patients, care partners, and clinicians hold discordant views about the responsibility for discussing ACP and the scope for it. This presents critical barriers to the process, leaving ACP insufficiently discussed with older adults with advanced CKD.

The limits of refusal: An ethical review of solid organ transplantation and vaccine hesitancy.

Patients pursuing solid organ transplantation are encouraged to receive many vaccines on an accelerated timeline. Vaccination prior to transplantation offers the best chance of developing immunity and may expand the pool of donor organs that candidates can accept without needing posttransplant therapy. Furthermore, transplant recipients are at greater risk for acquiring vaccine-preventable illnesses or succumbing to severe sequelae of such illnesses. However, a rising rate of vaccine refusal has challenged transplant centers to address the phenomenon of vaccine hesitancy. Transplant centers may need to consider adopting a policy of denial of solid organ transplantation on the basis of vaccine refusal for non-medical reasons (i.e., philosophical or religious objections or personal beliefs that vaccines are unnecessary or unsafe). Arguments supporting such a policy are motivated by utility, stewardship, and beneficence. Arguments opposing such a policy emphasize justice and respect for persons, and seek to avoid worsening inequities or medical coercion. This paper examines these arguments and situates them within the special cases of pediatric transplantation, emergent transplantation, and living donation. Ultimately, a uniform national policy addressing vaccine refusal among transplant candidates is needed to resolve this ethical dilemma and establish a consistent, fair, and standard approach to vaccine refusal in transplantation.