Sheila G. Jowsey-Gregoire

Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis: A Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop Report

Fatigue is one of the most highly prioritized outcomes for patients and clinicians, but remains infrequently and inconsistently reported across trials in hemodialysis. We convened an international Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop with stakeholders to discuss the development and implementation of a core outcome measure for fatigue. 15 patients/caregivers and 42 health professionals (clinicians, researchers, policy makers, and industry representatives) from 9 countries participated in breakout discussions. Transcripts were analyzed thematically. 4 themes for a core outcome measure emerged. Drawing attention to a distinct and all-encompassing symptom was explicitly recognizing fatigue as a multifaceted symptom unique to hemodialysis. Emphasizing the pervasive impact of fatigue on life participation justified the focus on how fatigue severely impaired the patients ability to do usual activities. Ensuring relevance and accuracy in measuring fatigue would facilitate shared decision making about treatment. Minimizing burden of administration meant avoiding the cognitive burden, additional time, and resources required to use the measure. A core outcome measure that is simple, is short, and includes a focus on the severity of the impact of fatigue on life participation may facilitate consistent and meaningful measurement of fatigue in all trials to inform decision making and care of patients receiving hemodialysis.

Childhood abuse is associated with worse survival following lung transplantation

Context: Psychosocial factors can impact lung transplant outcomes. However, it is currently unknown whether abuse survivorship influences lung transplant survival. Objective: To characterize the abuse history of adult lung transplant patients and determine whether such history is associated with mortality. Patients and Other Participants: Adult lung transplant recipients evaluated from 2000 to 2004. Main Outcome Measures: The main outcome was post-lung transplantation survival. The secondary outcomes included demographic, transplantation, or psychological assessment differences between those with a history of abuse survivorship and those without. Results: Thirty-three lung transplant recipients (35.5% male, median age: 55 years) were included. A history of abuse survivorship was common (24.2%) and was associated with decreased survival following lung transplantation (P = .003). There was no difference in sex, marital status, or smoking history between abuse survivors and those who denied being the victim of abuse. Abuse survivors had a higher Personality Assessment Screener total score, a measure of maladaptive personality traits (P = .02). Conclusion: Abuse survivorship is common in lung transplant patients and associated with increased posttransplant mortality and increased maladaptive personality traits. This preliminary evidence suggests that lung transplant patients should be screened for abuse history and provided with appropriate treatment of survivorship issues to potentially improve their health outcomes from transplantation.

Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus Workshop Report.

SONG-Tx. Background Graft loss, a critically important outcome for transplant recipients, is variably defined and measured and incompletely reported in trials. We convened a consensus workshop on establishing a core outcome measure for graft loss for all trials in kidney transplantation. Methods Twenty-five kidney transplant recipients/caregivers and 33 health professionals from eight countries participated. Transcripts were analyzed thematically. Results Five themes were identified. “Graft loss as a continuum” conceptualizesgraft loss as a process, but requiring an endpoint defined as a discrete event. In “defining an event with precision and accuracy,” loss of graft function requiring chronic dialysis(minimum 90 days)provided an objective and practical definition; re-transplant would capture pre-emptive transplantation; relisting was readily measured but would overestimate graft loss; and allograft nephrectomy was redundant in being preceded by dialysis. However, the thresholds for renal replacement therapy varied. Conservative management was regarded as too ambiguous and complexto use routinely. “Distinguishing death-censored graft loss” would ensure clarity and meaningfulness in interpreting results. “Consistent reporting for decision-making” by specifying time points and metrics (i.e. time to event) was suggested. “Ease of ascertainment and data collection” of the outcome from registries could support use of registry data to efficiently extend follow-up of trial participants. Conclusions A practical and meaningful core outcome measure for graft loss may be defined as chronic dialysis or re-transplant, and distinguished from loss due to death. Consistent reporting of graft loss using standardized metrics and time points may improve the contribution of trials to decision-making in kidney transplantation.

Psychosocial Risk Impacts Mortality in Women After Liver Transplantation

BACKGROUND Liver transplant candidates undergo psychosocial assessment as a component of their pretransplant evaluation. Global psychosocial assessment scales, including the Psychosocial Assessment of Candidates for Transplantation (PACT), capture and quantify these psychiatric and social variables. OBJECTIVE Our primary aim was to assess for an association between global PACT score and survival in liver transplant recipients. METHODS This retrospective cohort study examined records of all liver recipients at one U.S. Transplant Center from 2000 to 2012 with outcomes monitoring until 07/01/2016. We investigated for associations between the following variables and mortality: PACT score, age, gender, marital status, race, alcoholic liver disease (ALD), and body mass index (BMI). Statistical methods included Students t-test, Wilcoxon rank sum test, chi-square, Fishers exact test, Kaplan-Meier curve, and Cox proportional hazard models. RESULTS Of 1040 liver recipients, 538 had a documented PACT score. Among these, PACT score was not associated with mortality. In women, a lower PACT score was associated with mortality (p = 0.003) even after adjustments for age, marital status, and BMI. Women with ALD had a 2-fold increased hazard of death (p = 0.012). Increasing age was associated with increased risk of death for the cohort as a whole (p = 0.019) and for men (p = 0.014). In men, being married and BMI were marginally protective (p = 0.10 and p = 0.13, respectively). CONCLUSIONS Transplant psychosocial screening scales, specifically the PACT, identify psychosocial burden and may predict post-transplant outcomes in certain populations. In female liver recipients, lower PACT scores and ALD were associated with a greater risk of post-transplant mortality.

Younger Adults Initiating Hemodialysis: Antidepressant Use for Depression Associated With Higher Health Care Utilization

Objective: To examine associations between antidepressant use and health care utilization in young adults beginning maintenance hemodialysis (HD) therapy. Patients and Methods: Antidepressant use, hospitalizations, and emergency department (ED) visits were examined in young adults (N=130; age, 18‐44 years) initiating HD (from January 1, 2001, through December 31, 2013) at a midwestern US institution. Primary outcomes included hospitalizations and ED visits during the first year. Results: Depression diagnosis was common (47; 36.2%) at HD initiation, yet only 28 patients (21.5%) in the cohort were receiving antidepressant therapy. The antidepressant use group was more likely to have diabetes mellitus (18 [64.3%] vs 33 [32.4%]), coronary artery disease (8 [28.6%] vs 12 [11.8%]), and heart failure (9 [32.1%] vs 15 [14.7%]) (P<.05 for all) than the untreated group. Overall, 68 (52.3%) had 1 or more hospitalizations and 33 (25.4%) had 1 or more ED visits in the first year. The risk of hospitalization during the first year was higher in the antidepressant use group (hazard ratio, 2.35; 95% CI, 1.39‐3.96; P=.001), which persisted after adjustment for diabetes, coronary artery disease, and heart failure (hazard ratio, 1.94; 95% CI, 1.22‐3.10; P=.006). Emergency department visit rates were similar between the groups. Conclusion: Depression and antidepressant use for mood indication are common in young adult incident patients initiating HD and and are associated with higher hospitalization rates during the first year. Further research should determine whether antidepressants are a marker for other comorbidities or whether treated depression affects the increased health care use in these individuals.

Impact of psychiatric comorbidities on outcomes of elderly liver transplant recipients

OBJECTIVES This study evaluated the impact of psychiatric comorbidities in liver transplant (LT) recipients aged ≥65 years (elderly) on length of hospital-stay (LOS), death, and a composite outcome of graft loss or death. METHODS This retrospective study assessed impact of psychiatric comorbidities in 122 elderly LT recipients and a matched group of 122 LT recipients aged <65 years (younger). Associations were assessed using adjusted multivariable regression models. RESULTS Among elderly, median age at LT was 68 years, most were males (62%), white (85%) and 61.7% had a history of any psychiatric diagnosis. Among younger, median age was 55, most were males (67.2%), white (77.5%) and 61.5% had any psychiatric diagnosis. Median LOS was 8 days for both groups. Among elderly, after a median follow-up of 5 years, 25.4% died and 29.5% experienced graft loss or death. History of adjustment disorder, history of depression, past psychiatric medication use, and pain prior to LT were associated with an increased risk of death or the composite graft loss or death. Perioperative use of SSRIs and lack of sleeping medication use were associated with longer LOS. Among aged <65, after median follow-up of 4.7 years, 21 patients (17%) died and 25 (20%) experienced graft loss or death; history of depression, perioperative SSRIs or sleeping medications use was associated with increased mortality and graft-loss or death. CONCLUSION Six out of 10 patients among both elderly and younger cohorts had pre-LT psychiatric comorbidities, some of which adversely affected outcomes after LT.