Baseline Quality-of-Life of Caregivers of Patients With Heart Failure Prior to Advanced Therapies: Findings From the Sustaining Quality of Life of the Aged: Transplant or Mechanical Support (SUSTAIN-IT) Study.

BACKGROUND: We compared health-related quality of life (HRQOL), depressive symptoms, anxiety, and burden in caregivers of older patients with heart failure based on the intended therapy goal of the patient: awaiting heart transplantation (HT) with or without mechanical circulatory support (MCS) or prior to long-term MCS; and we identified factors associated with HRQOL. METHODS: Caregivers (n = 281) recruited from 13 HT and MCS programs in the United States completed measures of HRQOL (EQ-5D-3L), depressive symptoms (PHQ-8), anxiety (STAI-state), and burden (Oberst Caregiving Burden Scale). Analyses included ANOVA, Kruskal-Wallis tests, χ2 tests, and linear regression. RESULTS: The majority of caregivers were female, white spouses with ≤ 2 comorbidities, median [Q1,Q3] age = 62 [57.8, 67.0] years. Caregivers (HT with MCS = 87, HT without MCS = 98, long-term MCS = 96) reported similarly high baseline HRQOL (EQ-5D-3L visual analog scale median score = 90; P = 0.67 for all groups) and low levels of depressive symptoms. STAI-state median scores were higher in the long-term MCS group vs the HT groups with and without MCS, (38 vs 32 vs 31; P < 0.001), respectively. Burden (task: time spent/difficulty) differed significantly among groups. Caregiver factors (number of comorbidities, diabetes and higher anxiety levels) were significantly associated with worse caregiver HRQOL, R2 = 26%. CONCLUSIONS: Recognizing caregiver-specific factors, including comorbidities and anxiety, associated with the HRQOL of caregivers of these older patients with advanced HF may guide support strategies.

Trajectories of self-care agency and associated factors in lung transplant recipients over the first 12 months following transplantation.

Self-care agency (SCA), defined as one's ability and willingness to engage in self-care behaviors, can influence actual performance of self-care behaviors in lung transplant recipients (LTRs). Understanding patterns of SCA over time may inform the design of interventions to promote self-care in LTRs. Using group-based trajectory modeling, we sought to identify patterns and correlates of SCA among 94 LTRs over the first 12 months post-transplant. Baseline measures of sociodemographic, clinical, and psychosocial factors, and longitudinally assessed psychological distress were examined for their associations with predicted trajectory group membership. Three distinct stable (ie, zero slope) SCA trajectories were identified as follows: persistently low, persistently moderate, and persistently high. Based on the final multivariate model, requiring a re-intubation after transplant (P=.043), discharged to a facility rather than home (P=.048), and reporting a higher level of baseline anxiety (P=.001) were significantly associated with lower SCA. Linear mixed models revealed that higher levels of anxiety and depression were associated with lower SCA in the persistently moderate and low SCA groups over the 12-month time period (Ps<.05). LTRs who require a re-intubation after transplant and are discharged to a facility other than home, and report high psychological distress, may need additional assistance to engage in post-transplant self-care behaviors.

The Living Donor Collective: A Scientific Registry for Living Donors.

In the setting of an overall decline in living organ donation and new questions about long-term safety, a better understanding of outcomes after living donation has become imperative. Adequate information on outcomes important to donors may take many years to ascertain and may be evident only by comparing large numbers of donors with suitable controls. Previous studies have been unable to fully answer critical questions, primarily due to lack of appropriate controls, inadequate sample size, and/or follow-up duration that is too short to allow detection of important risks attributable to donation. The Organ Procurement and Transplantation Network does not follow donors long term and has no prospective control group with which to compare postdonation outcomes. There is a need to establish a national living donor registry and to prospectively follow donors over their lifetimes. In addition, there is a need to better understand the reasons many potential donors who volunteer to donate do not donate and whether the reasons are justified. Therefore, the US Health Resources and Services Administration asked the Scientific Registry of Transplant Recipients to establish a national registry to address these important questions. Here, we discuss the efforts, challenges, and opportunities inherent in establishing the Living Donor Collective.

Long-Term Follow-up of a Randomized Controlled Trial Evaluating a Mobile Health Intervention for Self-Management in Lung Transplant Recipients.

Mobile health interventions may help transplant recipients follow their complex medical regimens. Pocket Personal Assistant for Tracking Health (Pocket PATH) is one such intervention tailored for lung transplant recipients. A randomized controlled trial showed Pocket PATH's superiority to usual care for promoting the self-management behaviors of adherence, self-monitoring and communication with clinicians during posttransplant year 1. Its long-term impact was unknown. In this study, we examined associations between Pocket PATH exposure during year 1 and longer term clinical outcomes-mortality and bronchiolitis obliterans syndrome (BOS)-among 182 recipients who survived the original trial. Cox regression assessed whether (a) original group assignment and (b) performance of self-management behaviors during year 1 predicted time to outcomes. Median follow-up was 5.7 years after transplant (range 4.2-7.2 years). Pocket PATH exposure had no direct effect on outcomes (p-values >0.05). Self-monitoring was associated with reduced mortality risk (hazard ratio [HR] 0.45; 95% confidence interval [CI] 0.22-0.91; p = 0.027), and reporting abnormal health indicators to clinicians was associated with reduced risks of mortality (HR 0.15; 95% CI 0.04-0.65; p = 0.011) and BOS (HR 0.27; 95% CI 0.08-0.86; p = 0.026), regardless of intervention group assignment. Although Pocket PATH did not have a direct impact on long-term outcomes, early improvements in self-management facilitated by Pocket PATH may be associated with long-term clinical benefit.

Social and Financial Outcomes of Living Liver Donation: A Prospective Investigation Within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2).

Because results from single-center (mostly kidney) donor studies demonstrate interpersonal relationship and financial strains for some donors, we conducted a liver donor study involving nine centers within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2) consortium. Among other initiatives, A2ALL-2 examined the nature of these outcomes following donation. Using validated measures, donors were prospectively surveyed before donation and at 3, 6, 12, and 24 mo after donation. Repeated-measures regression models were used to examine social relationship and financial outcomes over time and to identify relevant predictors. Of 297 eligible donors, 271 (91%) consented and were interviewed at least once. Relationship changes were positive overall across postdonation time points, with nearly one-third reporting improved donor family and spousal or partner relationships and >50% reporting improved recipient relationships. The majority of donors, however, reported cumulative out-of-pocket medical and nonmedical expenses, which were judged burdensome by 44% of donors. Lower income predicted burdensome donation costs. Those who anticipated financial concerns and who held nonprofessional positions before donation were more likely to experience adverse financial outcomes. These data support the need for initiatives to reduce financial burden.

Long-Term Medical and Psychosocial Outcomes in Living Liver Donors.

Due to the enduring organ shortage, living donor liver transplantation has been a valuable treatment strategy for advanced liver disease patients for over 20 years. A variety of reviews have summarized the extensive data now available on medical and psychosocial risks to living donors in the aftermath of donation. However, evidence on donor medical and psychosocial outcomes beyond the first year postdonation has not been synthesized in any previous review. The evidence base on such "long-term" outcomes has been growing in recent years. A review of this evidence would therefore be timely and could serve as an important resource to assist transplant centers in their efforts to fully educate prospective donors and gain informed consent, as well as develop appropriate postdonation clinical care and surveillance plans. We reviewed recent literature on long-term donor outcomes, considering (a) medical outcomes, including mortality risk, rates of complications, abnormalities detected in laboratory testing, and the progress of liver regeneration; and (b) donor-reported psychosocial outcomes reflecting physical, emotional, and interpersonal/socioeconomic well-being, as well as overall health-related quality of life. We summarize limitations and gaps in available evidence, and we provide recommendations for future research and clinical care activities focused on long-term outcomes in liver donors.

Psychological Outcomes of Living Liver Donors From a Multicenter Prospective Study: Results From the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2).

Although single-center and cross-sectional studies have suggested a modest impact of liver donation on donor psychological well-being, few studies have assessed these outcomes prospectively among a large cohort. We conducted one of the largest, prospective, multicenter studies of psychological outcomes in living liver donors within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2) consortium. In total, 271 (91%) of 297 eligible donors were interviewed at least once before donation and at 3, 6, 12, and 24 mo after donation using validated measures. We found that living liver donors reported low rates of major depressive (0-3%), alcohol abuse (2-5%), and anxiety syndromes (2-3%) at any given assessment in their first 2 years after donation. Between 4.7% and 9.6% of donors reported impaired mental well-being at various time points. We identified significant predictors for donors' perceptions of being better people and experiencing psychological growth following donation, including age, sex, relationship to recipient, ambivalence and motivation regarding donation, and feeling that donation would make life more worthwhile. Our results highlight the need for close psychosocial monitoring for those donors whose recipients died (n=27); some of those donors experienced guilt and concerns about responsibility. Careful screening and targeted, data-driven follow-up hold promise for optimizing psychological outcomes following this procedure for potentially vulnerable donors.

Pattern and Predictors of Hospital Readmission During the First Year After Lung Transplantation.

Hospital readmission after lung transplantation negatively affects quality of life and resource utilization. A secondary analysis of data collected prospectively was conducted to identify the pattern of (incidence, count, cumulative duration), reasons for and predictors of readmission for 201 lung transplant recipients (LTRs) assessed at 2, 6, and 12 mo after discharge. The majority of LTRs (83.6%) were readmitted, and 64.2% had multiple readmissions. The median cumulative readmission duration was 19 days. The main reasons for readmission were other than infection or rejection (55.5%), infection only (25.4%), rejection only (9.9%), and infection and rejection (0.7%). LTRs who required reintubation (odds ratio [OR] 1.92; p = 0.008) or were discharged to care facilities (OR 2.78; p = 0.008) were at higher risk for readmission, with a 95.7% cumulative incidence of readmission at 12 mo. Thirty-day readmission (40.8%) was not significantly predicted by baseline characteristics. Predictors of higher readmission count were lower capacity to engage in self-care (incidence rate ratio [IRR] 0.99; p = 0.03) and discharge to care facilities (IRR 1.45; p = 0.01). Predictors of longer cumulative readmission duration were older age (arithmetic mean ratio [AMR] 1.02; p = 0.009), return to the intensive care unit (AMR 2.00; p = 0.01) and lower capacity to engage in self-care (AMR 0.99; p = 0.03). Identifying LTRs at risk may assist in optimizing predischarge care, discharge planning and long-term follow-up.

A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation.

Lung transplant recipients are encouraged to perform self-management behaviors, including (i) monitoring health indicators, (ii) adhering to their regimen, and (iii) reporting abnormal health indicators to the transplant coordinator, yet performance is suboptimal. When hospital discharge was imminent, this two-group trial randomized 201 recipients to use either the mobile health (mHealth) intervention (n = 99) or usual care (n = 102), to compare efficacy for promoting self-management behaviors (primary outcomes) and self-care agency, rehospitalization, and mortality (secondary outcomes) at home during the first year after transplantation. The mHealth intervention group performed self-monitoring (odds ratio [OR] 5.11, 95% confidence interval [CI] 2.95-8.87, p < 0.001), adhered to medical regimen (OR 1.64, 95% CI 1.01-2.66, p = 0.046), and reported abnormal health indicators (OR 8.9, 95% CI 3.60-21.99, p < 0.001) more frequently than the usual care group. However, the two groups did not differ in rehospitalization (OR 0.78, 95% CI 0.36-1.66, p = 0.51) or mortality (hazard ratio 1.71, 0.68-4.28, p = 0.25). The positive impact of the mHealth intervention on self-management behaviors suggests that the intervention holds promise and warrants further testing.

Consensus conference on best practices in live kidney donation: recommendations to optimize education, access, and care.

Live donor kidney transplantation is the best treatment option for most patients with late-stage chronic kidney disease; however, the rate of living kidney donation has declined in the United States. A consensus conference was held June 5-6, 2014 to identify best practices and knowledge gaps pertaining to live donor kidney transplantation and living kidney donation. Transplant professionals, patients, and other key stakeholders discussed processes for educating transplant candidates and potential living donors about living kidney donation; efficiencies in the living donor evaluation process; disparities in living donation; and financial and systemic barriers to living donation. We summarize the consensus recommendations for best practices in these educational and clinical domains, future research priorities, and possible public policy initiatives to remove barriers to living kidney donation.

The independent living donor advocate: a guidance document from the American Society of Transplantation's Living Donor Community of Practice (AST LDCOP).

The independent living donor advocate (ILDA) serves a mandated and supportive role in the care of the living organ donor, yet qualifications and role requirements are not clearly defined. Guidance comes from Centers for Medicare and Medicaid Services (CMS) Conditions for Transplant Center Participation and interpretive guidelines, Organ Procurement and Transplantation Network (OPTN) Policy and CMS and OPTN site surveys, yet interpretation of regulations varies. Herein, the AST Living Donor Community of Practice (LDCOP) offers seven recommendations to clarify and optimize the ILDA role: (a) the ILDA must have a certain skill set rather than a specific profession, (b) the ILDA must be educated and demonstrate competence in core knowledge components, (c) the ILDA's primary role is to assess components of informed consent, (d) centers must develop a transparent system to define ILDA independence, (e) the ILDA should have a reporting structure outside the transplant center, (f) the ILDA's role should be integrated throughout the donor care continuum, (g) the ILDA role should include a narrow "veto power." We address controversies in ILDA implementation, and offer pathways to maximize benefits and minimize limitations of approaches that may each meet regulatory requirements but confer different practice benefits. We propose a research agenda to explore the impact of the ILDA.

Associations between adjuvant endocrine therapy and onset of physical and emotional concerns among breast cancer survivors.

BACKGROUND: Breast cancer survivors often receive long-term adjuvant endocrine therapy (AET) to reduce recurrence risk. Adherence to AET is suboptimal, which may be due to the experience of symptoms and/or concerns. Few studies have comprehensively assessed self-reported concerns between those who currently, previously or have never received AET. The study objective is to describe self-reported physical and emotional concerns of breast cancer survivors who are current, prior, or never-recipients of AET. METHODS: Secondary analysis was performed on a subset of survey data collected in the 2010 LIVESTRONG Survey. Breast cancer survivors (n = 1,013, mean 5.4 years post-diagnosis) reported on 14 physical and eight emotional concerns that began after diagnosis and were experienced within 6 months of participation in the survey. Bivariate analyses examined the prevalence of each concern by AET status. The relationships between AET and burden of physical or emotional concerns were modeled with logistic regression. RESULTS: More than 50% of the participants reported currently experiencing cognitive issues, fatigue, fear of recurrence, emotional distress, and identity/grief issues. Thyroid dysfunction and stigma concerns were more common among participants with prior AET (p < 0.01), while fear of recurrence, emotional distress, and concern about appearance were more common among those currently receiving AET (p < 0.01). Fatigue, sexual dysfunction, and pain were more common among prior and current AET recipients (p < 0.01). In adjusted models, receipt of AET was associated with a higher number of physical, but not emotional concerns. A higher number of concerns was associated with younger age, having children, receipt of chemotherapy, longer duration of cancer treatment, and shorter time since diagnosis (p < 0.01). CONCLUSIONS: Breast cancer survivors who received AET were at risk of developing a variety of physical and emotional concerns, many of which persisted after treatment. These findings suggest the importance of developing individualized, supportive resources for breast cancer survivors.

Preventive intervention for living donor psychosocial outcomes: feasibility and efficacy in a randomized controlled trial.

There are no evidence-based interventions to prevent adverse psychosocial consequences after living donation. We conducted a single-site randomized controlled trial to examine the postdonation impact of a preventive intervention utilizing motivational interviewing (MI) to target a major risk factor for poor psychosocial outcomes, residual ambivalence (i.e. lingering hesitation and uncertainty) about donating. Of 184 prospective kidney or liver donors, 131 screened positive for ambivalence; 113 were randomized to (a) the MI intervention, (b) an active comparison condition (health education) or (c) standard care only before donation. Ambivalence was reassessed postintervention (before donation). Primary trial outcomes-psychosocial variables in somatic, psychological and family interpersonal relationship domains-were assessed at 6 weeks and 3 months postdonation. MI subjects showed the greatest decline in ambivalence (p = 0.050). On somatic outcomes, by 3 months postdonation MI subjects reported fewer physical symptoms (p = 0.038), lower rates of fatigue (p = 0.021) and pain (p = 0.016), shorter recovery times (p = 0.041) and fewer unexpected medical problems (p = 0.023). Among psychological and interpersonal outcomes, they had a lower rate of anxiety symptoms (p = 0.046) and fewer unexpected family-related problems (p = 0.045). They did not differ on depression, feelings about donation or family relationship quality. The findings suggest that the intervention merits testing in a larger, multisite trial.

Early treatment of depressive symptoms and long-term survival after liver transplantation.

While depression after liver transplantation (LTX) is associated with decreased survival, the effects of treating depression remain unknown. We assessed a previously described, prospective cohort of 167 patients transplanted for alcohol-related liver disease from 1998 to 2003. Depressive symptoms were measured with the Beck Depression Inventory serially throughout the first posttransplant year. Adequacy of antidepressant treatment was measured with the Antidepressant Treatment History Form. Using Cox-proportional Hazards modeling, survival times were assessed for recipients with no depression versus depression with adequate medications versus depression with inadequate medications. Seventy-two recipients had depressive symptoms in the first posttransplant year. Of these, 43% (n=31) received adequate pharmacotherapy and 57% (n=41) received inadequate (n=7) or no pharmacotherapy (n=34). After a median follow-up time of 9.5 years, 32% of the inadequately treated depressed group survived versus 52% of the adequately treated group and 56% of the nondepressed group (p=0.006). Compared to the nondepressed group, those with adequately treated depression had no significant difference in survival. However, recipients with depression and inadequate pharmacotherapy had decreased survival times compared to nondepressed recipients (HR for death=2.44, 95% CI=1.45, 4.11), controlling for other known confounders. The factor most strongly linked to long-term mortality after liver transplantation in this cohort was untreated depression.

Predictors and outcomes of health-related quality of life in caregivers of cardiothoracic transplant recipients.

Cardiothoracic transplant programs generally require that transplant recipients have family caregivers to assist them posttransplant. The burden of caregiving on the family members remains poorly understood. If caregivers' well-being is compromised by caregiving, it may bode poorly for transplant recipients' own health in the long-term posttransplant. We examined caregiver health-related quality of life (HRQOL) during the first year after their family member's transplant, its predictors and its relationship to subsequent patient survival. Adult (aged 18+) caregivers of 242 cardiothoracic transplant recipients (lung = 134; heart = 108) completed assessments of demographics, psychosocial characteristics and caregiver burden at 2 months posttransplant, and HRQOL at 2, 7 and 12 months posttransplant. Recipients' survival time was obtained from medical records. Caregiver HRQOL was generally high across the first-year posttransplant in emotional and social functioning; caregiver physical functioning significantly worsened. There were no differences by type of recipient transplant. Greater caregiver burden predicted poorer caregiver HRQOL in several physical domains at 12 months posttransplant. Transplant recipients whose caregivers had lower perceived general health at 12 months posttransplant showed poorer survival rates during the subsequent 7 years of follow up. Transplant teams should identify those caregivers at risk for poorer general health posttransplant to maximize positive outcomes for the entire family.

Solid-organ transplantation in older adults: current status and future research.

An increasing number of patients older than 65 years are referred for and have access to organ transplantation, and an increasing number of older adults are donating organs. Although short-term outcomes are similar in older versus younger transplant recipients, older donor or recipient age is associated with inferior long-term outcomes. However, age is often a proxy for other factors that might predict poor outcomes more strongly and better identify patients at risk for adverse events. Approaches to transplantation in older adults vary across programs, but despite recent gains in access and the increased use of marginal organs, older patients remain less likely than other groups to receive a transplant, and those who do are highly selected. Moreover, few studies have addressed geriatric issues in transplant patient selection or management, or the implications on health span and disability when patients age to late life with a transplanted organ. This paper summarizes a recent trans-disciplinary workshop held by ASP, in collaboration with NHLBI, NIA, NIAID, NIDDK and AGS, to address issues related to kidney, liver, lung, or heart transplantation in older adults and to propose a research agenda in these areas.

Motives and decision making of potential living liver donors: comparisons between gender, relationships and ambivalence.

The motives and decision making of potential living liver donors are critical areas for transplant clinicians evaluating these candidates to understand, yet these topics remain relatively unstudied. Thus, we surveyed 77 prospective living liver donors at the point of donation evaluation using structured instruments to gather more information on their approach to and concerns about donation. We collected information on donation decision making, motives for donation and anticipated social and physical concerns about postdonation outcomes. We examined three additional characteristics of donors: gender, the relationship of the donor to the intended recipient and the presence of ambivalence about donation. Women had more concerns about their family/social responsibilities. Those donating to nonimmediate family were more likely to have been asked to donate but less likely to feel they had to donate. However, ambivalent donors were the most distinct having difficulties and concerns across most areas from their motivations for donating, to deciding to be tested and to donate, to concerns about the postdonation outcomes. We discuss the clinical relevance of these findings to donor evaluation and preparation.

Early trajectories of depressive symptoms after liver transplantation for alcoholic liver disease predicts long-term survival.

Although it is well known that depression is associated with poorer medical outcomes, the association between depression- and liver transplant (LTX)-specific outcomes has not been investigated. We identified three trajectories of depressive symptoms evolving within the first post-LTX year in a cohort of 167 patients transplanted for alcoholic cirrhosis: a group with consistently low depression levels at all time points (group 1, n = 95), a group with initially low depression levels that rose over time (group 2, n = 41), and a group with consistently high depression levels (group 3, n = 31). Controlling for medical factors associated with poorer survival, recipients with increasing depression or persisting depression were more than twice as likely to die (all cause mortality) within the subsequent years. At 10 years post-LTX the survival rate was 66% for the low depression group, but only 46% and 43%, respectively, for the increasing depression and high depression groups. Except for a paradoxically higher percentage of malignancies in the low depression group, the causes of death and other specific LTX outcomes were not different between groups. Whether treatment of depression will improve survival rates is an area for research.

The long-term quality of life of living kidney donors: a multicenter cohort study.

Previous studies that described the long-term quality of life of living kidney donors were conducted in single centers, and lacked data on a healthy nondonor comparison group. We conducted a retrospective cohort study to compare the quality of life of 203 kidney donors with 104 healthy nondonor controls using validated scales (including the SF36, 15D and feeling thermometer) and author-developed questions. Participants were recruited from nine transplant centers in Canada, Scotland and Australia. Outcomes were assessed a median of 5.5 years after the time of transplantation (lower and upper quartiles of 3.8 and 8.4 years, respectively). 15D scores (scale of 0 to 1) were high and similar between donors and nondonors (mean 0.93 (standard deviation (SD) 0.09) and 0.94 (SD 0.06), p = 0.55), and were not different when results were adjusted for several prognostic characteristics (p = 0.55). On other scales and author-developed questions, groups performed similarly. Donors to recipients who had an adverse outcome (death, graft failure) had similar quality of life scores as those donors where the recipient did well. Our findings are reassuring for the practice of living transplantation. Those who donate a kidney in centers that use routine pretransplant donor evaluation have good long-term quality of life.