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Purpose: The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. However, the relationship between domain scores and functional outcomes remains unclear, leading to potential confusion about expectations after treatment. For instance, does a sexual function domain score of 80 mean that a patient can achieve erection sufficient for intercourse? Consequently we sought to determine the relationship between the domain score and the response to obtaining the best possible outcome for each question., Materials and Methods: Using data from the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study, a multicenter, prospective study of men diagnosed with localized prostate cancer, we analyzed 11,464 EPIC-26 questionnaires from a total of 2,563 men at baseline through 60 months of followup who were treated with robotic prostatectomy, radiotherapy or active surveillance. We dichotomized every item into its best possible outcome and assessed the percent of men at each domain score who achieved the best result., Results: For every EPIC-26 item the frequency of the best possible outcome was reported by domain score category. For example, a score of 80 to 100 on sexual function corresponded to 97% of men reporting erections sufficient for intercourse while at a score of 40 to 60 only 28% reported adequate erections. Also, at a score of 80 to 100 on the urinary incontinence domain 93% of men reported rarely or never leaking vs 6% at a score of 61 to 80., Conclusions: Our findings indicate a novel way to interpret EPIC-26 domain scores, demonstrating large variations in the percent of respondents reporting the best possible outcomes over narrow domain score differences. This information may be valuable when counseling men on treatment options.

Background: Single lung transplantation (SLT) and double lung transplantation (DLT) are associated with differences in morbidity and mortality, although the effects of transplant type on patient-reported outcomes are not widely reported and conclusions have differed. Previous studies compared mean health-related quality of life (HRQOL) scores but did not evaluate potentially different temporal trajectories in the context of longitudinal follow-up. To address this uncertainty, this study was designed to evaluate longitudinal HRQOL after SLT and DLT with the hypothesis that temporal trajectories differ between SLT and DLT., Methods: Patients transplanted at a single institution were eligible to be surveyed at 1 month, 3 months, 6 months, and then annually after transplant using the Short Form 36 Health Survey, with longitudinal physical component summary (PCS) and mental component summary (MCS) scores as the primary outcomes. Multivariable mixed-effects models were used to evaluate the effects of transplant type and time posttransplant on longitudinal PCS and MCS after adjusting age, diagnosis, rejection, Lung Allocation Score quartile, and intubation duration. Time by transplant type interaction effects were used to test whether the temporal trajectories of HRQOL differ between SLT and DLT recipients. HRQOL scores were referenced to general population norms (range, 40 to 60; mean, 50 ± 10) using accepted standards for a minimally important difference (½ SD, 5 points)., Results: Postoperative surveys (n = 345) were analyzed for 136 patients (52% male, 23% SLT, age 52 ± 13 years, LAS 42 ± 12, follow-up 37 ± 29 months [range, 0.6 to 133]) who underwent lung transplantation between 2005 and 2016. After adjusting for model covariates, overall posttransplant PCS scores have a significant downward trajectory (p = 0.015) whereas MCS scores remain stable (p = 0.593), with both averaging within general population norms. The time by transplant type interaction effect (p = 0.002), however, indicate that posttransplant PCS scores of SLT recipients decline at a rate of 2.4 points per year over the total observation period compared to DLT. At approximately 60 months, the PCS scores of SLT recipients, but not DLT recipients, fall below general population norms., Conclusions: The trajectory of physical HRQOL in patients receiving SLT declines over time compared with DLT, indicating that, in the longer term, SLT recipients are more likely to have physical HRQOL scores that fall substantively below general population norms. Physical HRQOL after 5 years may be a consideration for lung allocation and patient counseling regarding expectations when recommending SLT or DLT., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Attaining glycemic targets without severe hypoglycemic events (SHEs) is a challenging treatment goal for patients with type 1 diabetes complicated by impaired awareness of hypoglycemia (IAH). The CIT Consortium Protocol 07 (CIT-07) trial showed islet transplantation to be an effective treatment for subjects with IAH and intractable SHEs. We evaluated health-related quality of life (HRQOL), functional health status, and health utility before and after pancreatic islet transplantation in CIT-07 trial participants., Research Design and Methods: Four surveys, the Diabetes Distress Scale (DDS), the Hypoglycemic Fear Survey (HFS), the Short Form 36 Health Survey (SF-36), and the EuroQoL 5 Dimensions (EQ-5D), were administered repeatedly before and after islet transplantation. Summary statistics and longitudinal modeling were used to describe changes in survey scores from baseline and to characterize change in relation to a minimally important difference (MID) threshold of half an SD., Results: Improvements in condition-specific HRQOL met the MID threshold. Reductions from baseline in the DDS total score and its four DDS subscales (all P ≤ 0.0013) and in the HFS total score and its two subscales (all P < 0.0001) were observed across all time points. Improvements were observed after both 1 and 2 years for the EQ-5D visual analog scale (both P < 0.0001)., Conclusions: In CIT-07, 87.5% of the subjects achieved the primary end point of freedom from SHE along with glycemic control (HbA 1c <7% [<53 mmol/mol]) at 1 year post-initial islet transplantation. The same subjects reported consistent, statistically significant, and clinically meaningful improvements in condition-specific HRQOL as well as self-assessments of overall health., (© 2018 by the American Diabetes Association.)

Background: The United Network for Organ Sharing system allocates deceased donor kidneys based on the kidney donor profile index (KDPI), stratified as sequences (A ≤ 20%, B > 20-<35%, C ≥ 35-≤85%, and D > 85%), with increasing KDPI associated with decreased graft survival. While health-related quality of life (HRQOL) may improve after transplantation, the effect of donor kidney quality, reflected by KDPI sequence, on post-transplant HRQOL has not been reported., Methods: Health-related quality of life was measured using the eight scales and physical and mental component summaries (PCS, MCS) of the SF-36 ® Health Survey. Multivariable mixed effects models that adjusted for age, gender, rejection, and previous transplant and analysis of variance methods tested the effects of time and KDPI sequence on post-transplant HRQOL., Results: A total of 141 waitlisted adults and 505 recipients (>1700 observations) were included. Pretransplant PCS and MCS averaged, respectively, slightly below and within general population norms (GPN; 40-60). At 31 ± 26 months post-transplant, average PCS (41 ± 11) and MCS (51 ± 11), overall and within each KDPI sequence, were within GPN. KDPI sequence was not related to post-transplant HRQOL (P > .134) or its trajectory (interaction P > .163)., Conclusion: Increasing KDPI does not adversely affect the medium-term values and trajectories of HRQOL after kidney transplantation. This may reassure patients and centers when considering using high KDPI kidneys., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: The reported effects of biliary injury on health-related quality of life (HRQOL) have varied widely. Meta-analysis methodology was applied to examine the collective findings of the long-term effect of bile duct injury (BDI) on HRQOL., Methods: A comprehensive literature search was conducted in March, 2012. Because the HRQOL surveys differed among reports, BDI and uncomplicated laparoscopic cholecystectomy (LC) groups' HRQOL scores were expressed as effect sizes (ES) in relation to a common, general population, standard. A negative ES indicated a reduced HRQOL, with a substantive reduction defined as an ES ≤ -0.50. Weighted logistic regression tested the effects of BDI (versus LC) and follow-up time on whether physical and mental HRQOL were substantively reduced., Results: Data were abstracted from six publications, which encompass all reports of HRQOL after BDI in the current, peer-reviewed literature. The analytic database comprised 90 ES computations representing 831 patients and 11 unique study groups (six BDI and five LC). After controlling for follow-up time (P ≤ 0.001), BDI patients were more likely to have reduced long-term mental [odds ratio (OR) = 38.42, 95% confidence interval (CI) = 19.14-77.10; P < 0.001] but not physical (P = 0.993) HRQOL compared with LC patients., Discussion: This meta-analysis of findings from six peer-review reports indicates that, in comparison to LC, there is a long-term detrimental effect of BDI on mental HRQOL., (© 2012 International Hepato-Pancreato-Biliary Association.)

Background: Although current national data show improved graft and patient survival following lung transplant, the effects of several modifiable preexisting comorbid conditions on health-related quality of life after transplant have not been evaluated. This study examines the effects of 3 comorbid conditions present before lung transplant (reduced bone density, diabetes mellitus, and elevated body mass index) on health-related quality of life after lung transplant., Methods: The Short Form 36 Health Survey was completed by 92 adult recipients at various times after lung transplant (mean, 41 months; range, 1-127 months). Multiple linear regression models that controlled for underlying disease, chronic rejection, and time after transplant tested the independent effects of the 3 pretransplant conditions on posttransplant health-related quality of life., Results: The effects of pretransplant reduced bone density and diabetes mellitus were not statistically significant in these models. However, pretransplant body mass index had a significant negative effect (β = -.29, P = .007) on posttransplant physical health-related quality of life. Additionally, overweight status and obesity exerted comparable independent negative effects (P = .01 and P = .03, respectively) on the physical function scale of the Short-Form 36 Health Survey compared with persons who were underweight or normal weight before transplant., Conclusions: Reevaluation of elevated body mass index before transplant as a risk for reduced physical quality of life after lung transplant should be considered.

Objective: Radical cystectomy (RC) for bladder cancer can be associated with significant morbidity and alterations in health-related quality of life (HRQOL). The Functional Assessment of Cancer Therapy--Vanderbilt Cystectomy Index (FACT-VCI) is a condition-specific HRQOL survey for patients undergoing RC and urinary diversion (UD) for bladder cancer. This study evaluates the reliability, validity, and responsiveness of the Vanderbilt cystectomy index (VCI)., Methods: The FACT-VCI was administered to patients with bladder cancer undergoing RC and UD (n = 190) at 2 major cancer centers. Statistical methods included principal components analysis, Cronbach's coefficient alpha, and nonparametric correlation coefficients. The Functional Assessment of Cancer Therapy--General (FACT-G) was used to test criterion-related validity and a linear mixed model tested the effects of time and diversion type on longitudinal VCI scores., Results: A single summary score of 15 gender-neutral items (VCI-15) represented the optimum solution for postoperative data, which was internally consistent (α = 0.85), had strong retest reliability (ρ = 0.891), and was associated with all FACT-G scales and total score (ρ ≥ 0.38, P <.001). Preoperatively, the VCI-15 was internally consistent (α = 0.77) and was associated with the FACT-G physical and functional scales and total score (ρ ≥ 0.41, P <.001). Although VCI-15 scores at postoperative year 1 did not differ from preoperative values overall (P = .145), they did differ by diversion type (P = .027), with no substantive change after orthotopic neobladder (40 ± 9 vs 39 ± 10) but with a clinically significant improvement after an ileal conduit (39 ± 11 vs 44 ± 11)., Conclusion: The VCI-15 is a reliable and valid condition-specific HRQOL survey for patients with bladder cancer undergoing RC and UD. Future studies of RC patients should measure HRQOL using validated, condition-specific forms, such as the FACT-VCI., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Corticosteroid use during post-transplant immunosuppression contributes to documented long-term complications in liver transplant recipients. However, the effects of steroids on post-transplant physical and mental health-related quality of life (HRQOL) have not been established. We aimed to test the association between steroid-based immunosuppression and post-transplant HRQOL in liver transplant recipients., Study Design: We performed a retrospective analysis of prospective, longitudinal HRQOL measured using the Short Form 36 Health Survey physical and mental component summary scores, Beck Anxiety Inventory, and Center for Epidemiologic Studies Depression Scale. Steroid use (none, low [<10 mg/d], high [≥10 mg/d]) and temporally associated acute rejection (within previous 6 weeks, previous 7 to 12 weeks, and never or >12 weeks before HRQOL measurement) were determined at every post-transplant HRQOL data point. Linear mixed-effects models tested the effects of contemporaneous steroid use and dosing on post-transplant HRQOL., Results: The sample included 186 adult liver transplant recipients (mean age 54 ± 8 years, 70% male) with pre- and at least 1 post-transplant HRQOL data point. Individual follow-up post-transplant averaged 21 ± 18 months (range 1 to 74 months). After controlling for pre-transplant HRQOL, time post-transplant, pre-transplant diagnosis group, and temporally associated episodes of rejection, post-transplant high-dose steroid use (≥10 mg/d) was associated with lower physical component summary (p < 0.001) and mental component summary (p = 0.049) scores and increased Beck Anxiety Inventory (p = 0.015) scores. Low-dose steroid use (<10 mg/d) was not associated with post-transplant HRQOL in any model (all p ≥ 0.28)., Conclusions: High-dose steroid use for post-transplant immunosuppression in liver transplant recipients was associated with reduced physical and mental HRQOL, and increased symptoms of anxiety. There was an association between better HRQOL and steroid reduction to <10 mg/d in liver transplant recipients during a broad follow-up period., (Copyright © 2012 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Recent studies demonstrate that obesity does not affect survival after kidney transplantation. However, overweight and obesity impair health-related quality of life (HRQOL) in patients with chronic illnesses. We wished to examine the effects of pre-transplant overweight and obesity on post-transplant physical HRQOL in kidney transplant recipients., Study Design: Patient-reported HRQOL data were systematically collected in kidney transplant recipients receiving post-transplant follow-up at Vanderbilt Transplant Center. Patients who received kidney transplants between 1998 and 2008, had at least 1 post-transplant physical component summary (PCS) measurement, and did not receive other solid organ transplants were included in this retrospective cohort study. Pre-transplant body mass index was stratified as normal, overweight, obese class I, and obese class II/extremely obese. HRQOL was measured primarily with the PCS scale of the Medical Outcomes Study Short Form 36 Health Survey. Multivariate linear and logistic regression models were used to test the effects of body mass index and demographic and clinical covariates on post-transplant HRQOL., Results: The study cohort included 464 adults (mean body mass index 27.5 +/- 5.1; range 18.5 to 47.4). After controlling for gender (p = 0.148), pre-transplant dialysis (p = 0.003), previous kidney transplantation (p = 0.255), donor type (p = 0.455), steroid avoidance immunosuppression (p = 0.070), and follow-up time (p = 0.352), there was no effect of pre-transplant overweight or obesity on post-transplant PCS (all p > or = 0.112). Kidney transplant recipients who did not require dialysis pre-transplant and those who were managed with steroid avoidance after transplantation were more likely to achieve post-transplant PCS scores at or above the general population average (both p < or = 0.011)., Conclusions: Pre-transplant overweight and obesity do not affect physical quality of life after kidney transplantation., (Copyright 2010 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Aim: This paper is a report of a study investigating the effects of clinical factors (side effects of immunosuppressive medications, transplant-related hospitalizations, donor type, duration of dialysis before transplantation and time post-transplant) on cognitive appraisal of health, perceived self-efficacy, perceived social support, coping and health-related quality of life after renal transplantation., Background: Some clinical factors such as hospitalizations, side effects of medications, donor type and dialysis, which influence the health-related quality of life of renal transplant recipients, have been investigated. However, the effects of these clinical factors on psychosocial variables after renal transplantation have not been well documented. Method. Using a descriptive cross-sectional design, a convenience sample of 160 renal transplant recipients was recruited (N = 55 < 1 year post-transplant; N = 105 1-3 years post-transplant) from May, 2005 to January, 2006. Standardized instruments were used to measure the key constructs. Multivariate analysis of variance was used to examine the effects of clinical factors on the psychosocial outcome measures., Results: Participants reporting more (>17) immunosuppressive medication-associated side effects appraised their health more negatively, used more disengagement coping, had lower degrees of perceived self-efficacy, and reported lower physical and mental health-related quality of life than those with fewer symptoms (

Background: Recent studies suggest that obesity does not affect survival after liver transplantation. Overweight and obesity, however, impair health-related quality of life (HRQOL) in patients with chronic illnesses. We tested the effect of pretransplant body weight on HRQOL in liver transplant recipients., Methods: Prospective, longitudinal HRQOL data were collected using the SF-36 health survey. Pretransplant body weight was stratified based on body mass index (BMI), as follows: normal (18.5-24.9), overweight (25.0-29.9), and obese (> or =30.0). Linear mixed-effects models were used to test the effects pretransplant BMI category on the trajectory of HRQOL after liver transplantation., Results: The sample included 154 adults who underwent liver transplantation. Thirty-one percent had normal BMI, 41% were overweight, and 28% were obese pretransplant. The mean pretransplant physical HRQOL did not differ by BMI group (P > or = .697). Physical and mental HRQOL improved (P < .001) in all groups after transplantation, but the rate of improvement in physical HRQOL was significantly greater during the first year posttransplant in the normal BMI compared with the overweight and obese patients (P < or = .032). There was no effect of BMI on the rate of improvement in mental HRQOL., Conclusion: Excess pretransplant body weight hinders the rate of improvement in physical quality of life during the first year after liver transplantation.

Objective: To determine whether a correlation exists between the Model for End-Stage Liver Disease (MELD) score and health-related quality of life (HRQOL) after liver transplant (LT)., Design: Prospective cohort., Setting: University hospital., Patients: Adult LT recipients (N = 209)., Main Outcome Measures: Postoperative HRQOL over a 1-year period after LT as measured via multiple regression-based path analysis testing the effects of the MELD score, preoperative variables, and postoperative variables on scores on the physical component summary and mental component summary scales of the 36-Item Short Form Health Survey and on composite physical and mental HRQOL scores derived from multiple scales., Results: The MELD score (beta = .16), cholestatic cirrhosis (beta = .12), autoimmune/metabolic disease (beta = .18), neoplasm (beta = .23), time after LT (beta = .16), and the Karnofsky score (beta = .49) had significant effects on the physical component summary scale score. Autoimmune/metabolic disease (beta = .16) and the Karnofsky score (beta = .25) had significant effects on the mental component summary scale score. The MELD score (beta = .15), high school education (beta = .15), college education (beta = .17), autoimmune/metabolic disease (beta = .15), neoplasm (beta = .23), time after LT (beta = .11), and the Karnofsky score (beta = .51) had significant effects on the composite physical HRQOL score. Autoimmune/metabolic disease (beta = .23), neoplasm (beta = .15), and the Karnofsky score (beta = .42) had significant effects on the composite mental HRQOL score., Conclusions: An increasing MELD score, when computed without any diagnosis-based exception points, was associated with improved physical HRQOL in the first year after LT. The MELD score did not affect mental HRQOL.

Health utility instruments assess patients' valuation of specific health states, which can be converted to quality-adjusted life years for cost-utility analysis. Data from the EQ-5D, a generic health-related quality of life questionnaire from EuroQoL, can be reported as 5 health status scores or as a single health preference weight (HPW). US population-based HPWs were published by Shaw and colleagues in 2005 (Med Care 2005;43:203-220). Our aim was to test the validity of US EQ-5D HPWs and health status scores in liver transplant patients. EQ-5D scores were converted to HPWs with Shaw et al.'s model. Data were stratified by measurement period: pretransplant period, early posttransplant period (< or =12 months), intermediate posttransplant period (13-36 months), and late posttransplant period (>36 months). EQ-5D scores were compared to specific, hypothesized Short Form 36 Health Survey, Center for Epidemiologic Studies Depression Scale, and Beck Anxiety Inventory scores that were identified a priori on the basis of construct similarity. Criterion-related and construct validity were tested with nonparametric methods. Two hundred eighty-five adults participated (113 in the pretransplant period, 60 in the early posttransplant period, 47 in the intermediate posttransplant period, and 65 in the late posttransplant period), and follow-up averaged 36 +/- 36 months. Eighty-one percent of the hypothesized relationships between EQ-5D and gold-standard scales were strong (r > or = |0.5|, P < 0.001), and the remainder were moderate (r > |0.3|, P < 0.001). Differences between pretransplant and posttransplant EQ-5D HPWs were statistically significant. In conclusion, EQ-5D dimensions and the health utility index generated from Shaw's US population preference weights demonstrated criterion-related and construct validity in liver transplant patients. It is a valid instrument for cost-utility analysis in this setting., (Copyright 2008 AASLD.)

Aims and Objectives: To evaluate whether gender, age and their interaction affect health-related quality of life and overall health status following kidney transplantation., Background: Some investigators have examined the main effects of gender and/or age on health-related quality of life following kidney transplantation, but the potential interaction effect of these measures on this outcome has not been reported., Design: This was a cross-sectional, single-centre study, based in one US geographic area., Methods: Self-report survey data were provided by adult kidney transplant recipients using the SF-36 Health Survey (SF-36) and a visual analogue scale of overall health. SF-36 physical and mental component summary and individual scales and overall health were measured prospectively at one time point post-transplant. All adult patients were eligible to participate and rolling enrolment was employed. Statistical effects were tested using analysis of covariance (controlling for time post-transplant)., Results: Subjects (n = 138) included 66 women and 72 men. There were no effects of gender, age group, or their interaction on MCS or overall health scores (all p >or= 0.12). Physical component summary scale data demonstrated: (i) a significant effect of gender (p = 0.025); (ii) a statistically marginal effect of age group (p = 0.068); and (iii) a statistically marginal gender by age group interaction effect (p = 0.066). Women reported poorer scores on the SF-36 physical functioning (p = 0.049), role physical (p = 0.014) and bodily pain scales (p = 0.028). There was an effect of age group on physical functioning (p = 0.005), with younger patients reporting higher scores., Conclusions: Women report lower scores on several physical measures and may experience a greater reduction with age in physical health-related quality of life than men. Physical functioning declines with age following kidney transplantation., Relevance to Clinical Practice: Findings may help healthcare professionals to develop gender- and age-specific interventions to optimize health-related quality of life of kidney transplant patients.

Previous research demonstrated that physical health-related quality of life (HRQOL) improves after liver transplantation, but improvements in mental HRQOL are less dramatic. The aim of this study was to test the effects of physical HRQOL, time post-transplant, and gender on pre- to post-transplant change in anxiety and depression. Longitudinal HRQOL data were prospectively collected at specific times before and after liver transplantation using the SF-36(R) Health Survey (SF-36), Center for Epidemiologic Studies Depression Scale (CES-D), and Beck Anxiety Inventory (BAI). Within-subject change scores were computed to represent the longest follow-up interval for each patient. Multiple regression was used to test the effects of baseline score, time post-transplant, gender, and SF-36 physical component summary scores (PCS) on change in BAI and CES-D scores. About 107 patients (74% male, age=54+/-8 years) were included in the analysis. Time post-transplant ranged 1 to 39 months (mean=9+/-8). Improvement in symptoms of anxiety and depression was greatest in those patients with the most severe pre-transplant symptoms. Significant improvement in symptoms of depression occurred after liver transplant, but the magnitude of improvement was smaller with time suggesting possible relapse of symptoms. Better post-transplant physical HRQOL was associated with a greater reduction in symptoms of anxiety and depression after liver transplantation. This demonstrates clear improvements in post-transplant mental HRQOL and the significant relationships between physical and mental HRQOL.

Objective: To present an overview of methods for incorporating the measurement of health-related quality of life and patient satisfaction into a comprehensive outcomes assessment program in the organ transplantation setting. An introduction to basic psychometric concepts as they relate to survey instrument selection is presented, and the complementary nature of health status instruments and preference-based utility measures is discussed. The role of these concepts and measures in a transplant outcomes assessment and research program and the psychometric evidence for selected instruments are described., Data Sources: Descriptions of specific survey instruments were abstracted from published reports or manuals. Data describing the Vanderbilt Transplant Center Patient Satisfaction Inventory were derived from a single institution transplant outcomes research database., Study Selection and Data Extraction: Previously reported research was selected from the literature to provide brief examples of basic concepts, which are not intended to be a comprehensive review of these topics. Illustrative data from the Vanderbilt program were extracted from a longitudinal database., Data Synthesis: Data and published reports were synthesized for descriptive and illustrative purposes., Conclusions: This review describes various types of health-related quality of life and patient satisfaction outcomes assessment tools and measurement methods; introduces considerations relevant to survey instrument selection and development; and outlines the evolution of and psychometric support for a transplant center-wide outcomes assessment and research program.

Hypothesis: Donor, technical, and recipient risk factors cumulatively impact survival and health-related quality of life after liver transplantation., Design: Retrospective study., Setting: Tertiary care center., Patients: A total of 483 adults undergoing primary orthotopic liver transplantation between January 1, 1991, and July 31, 2003., Main Outcome Measures: Graft and patient survival, Karnofsky functional performance scores, Medical Outcomes Study Short Form 36 Health Survey scores, and Psychosocial Adjustment to Illness Scale scores as influenced by potential risk factors including donor age, weight, warm ischemia time, cold ischemia time (CIT), sex, United Network for Organ Sharing (UNOS) status (1 or 2A vs 2B or 3), recipient age and disease, bilirubin level, and creatinine level., Results: Five-year graft survival was 72% for recipients of donors younger than 60 years and 35% for recipients of donors 60 years and older (P<.001). A CIT of 12 hours or more was associated with shorter 5-year graft survival (71% vs 58%; P = .004). Five-year graft survival for UNOS status 2B or 3 was 71% vs 60% for status 1 or 2A (P = .02). A comparable pattern was seen for patient survival in relation to donor age (P = .003), CIT (P = .005), and urgency status (P = .03). Urgent UNOS status, advanced donor age, and prolonged CIT were independently associated with shorter graft and patient survival (P<.05). Functional performance and health-related quality of life were not affected by donor, recipient, or technical characteristics., Conclusions: Combining advanced donor age, urgent status, and prolonged CIT adversely affects graft and patient survival, and the cumulative effects of these risk factors can be modeled to predict posttransplant survival.

Background: We sought to determine if disparities in survival and health-related quality of life (HRQOL) occurred after solid organ transplantation at our institution., Methods: Data were extracted from a database including information regarding transplants that took place from 1990 to 2002. The HRQOL was assessed in patients by using the Karnofsky functional performance (FP) index and the Medical Outcomes Study Short Form 36 (SF-36) questionnaire., Results: Data were collected on recipients of liver (n = 413), heart (n = 299), kidney (n = 892), and lung (n = 156). Blacks represented a minority of recipients: liver 7%, heart 8%, kidney 23%, and lung 6%. There were no statistically significant differences in patient survival between blacks and whites. Graft survival differed in kidney only with a 5-year survival: 72% for blacks versus 79% for whites (P <0.001). The FP and HRQOL improved (P <0.05) after transplantation in both groups. There were no differences on measures of the FP or HRQOL., Conclusions: Blacks had comparable survival and improvement in FP and HRQOL in comparison with whites.

Retrospective studies suggest that resection improves 5-year survival for patients with hepatic carcinoid metastasis (HCM). The purpose of our study was to describe clinical outcomes following resection for HCM, including survival and longitudinal functional quality of life (QOL). We reviewed the records of patients undergoing resection for HCM from 1980 to 2001 at our institution. Outcome measures included tumor symptoms, biochemical tumor markers, functional QOL through Karnofsky functional scores, and survival. Thirteen patients underwent a total of 17 resections. Overall 5-year survival was 85%. Eleven patients were symptomatic, including eight with classic carcinoid syndrome. Nine experienced complete relief of symptoms and two had incomplete relief for 30 +/- 12 months. Eight patients had elevated tumor markers, and 50% of these had postoperative normalization of all tumor markers that persisted to the close of the study. For the 10 patients with longitudinal follow-up available to 54 months, significant improvement in functional QOL was observed at all follow-up time points compared to preresection functional QOL (P < 0.05). Resection of >/=90% tumor volume was significantly associated with more favorable survival and tumor marker normalization compared to resection of <90% tumor volume (P < 0.01 and P < 0.05, respectively), but trajectory of functional QOL improvement did not differ between these two groups (P=0.24). We conclude that resection for HCM is associated with significantly improved and sustained functional QOL and prolonged survival. Resection of >/=90% tumor volume is significantly associated with extended survival and normalization of tumor markers, but is not required for symptomatic or functional QOL improvement.

Hypothesis: Long-term quality of life (QOL) in patients undergoing laparoscopic cholecystectomy (LC) incurring bile duct injury (BDI) and repair is comparable to that of patients undergoing uncomplicated LC., Design: Case comparison study., Setting: Secondary and tertiary care centers., Patients: Eighty-six patients incurring BDI during LC between January 1, 1991, and July 31, 2003, were surveyed. Comparison subjects underwent uncomplicated LC during the same period., Main Outcome Measures: Health-related QOL as assessed by the Karnofsky Performance Scale, Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), and Psychosocial Adjustment to Illness Scale., Results: Fifty patients with BDI (39 [78%] female; mean +/- SEM age, 55 +/- 2 years) and 74 patients with uncomplicated LC (51 [69%] female, mean +/- SEM age, 52 +/- 2 years) responded. Of the 50 BDI patients, 48 (96%) had no stricture and normal liver function at QOL assessment. The mean +/- SEM follow-up period to QOL assessment for the BDI and uncomplicated LC groups was 62 +/- 6 and 47 +/- 3 months, respectively. The mean +/- SD Karnofsky Performance Scale scores were 77 +/- 9 vs 93 +/- 8 for the 2 groups, respectively (P <.001). The mean +/- SD SF-36 physical component scale scores after BDI vs uncomplicated LC were 36 +/- 11 vs 47 +/- 12, respectively (P <.001), compared with 50 +/- 10 for the normal population (P <.001). The mean +/- SD SF-36 mental component scale scores were 43 +/- 14 vs 49 +/- 11 for the 2 groups, respectively (P =.02), compared with 50 +/- 10 for the normal population (P =.01). Patients with BDI scored poorer on the Psychosocial Adjustment to Illness Scale health care orientation and domestic environment scales (P=.01)., Conclusion: After BDI and repair, there are long-term detrimental effects of BDI on health-related QOL.

Background: The current study was undertaken to identify factors specific to kidney transplantation that are associated with posttransplant functional performance (FP) and health-related quality of life (HRQOL)., Methods: Karnofsky FP status was assessed longitudinally in 86 adult kidney transplant recipients. Patients reported HRQOL using the Short Form-36 (SF-36) health survey and the Psychosocial Adjustment to Illness Scale (PAIS)., Results: FP improved (P <0.001) after kidney transplantation (from 75 +/- 1 to 77 +/- 1, 81 +/- 1, and 82 +/- 1 at 0, 3, 6, and 12 months, respectively). Patients receiving organs from living donors showed continued improvement through posttransplant year 1 while those receiving cadaveric organs stabilized at month 6 (simple interaction contrast, year 1 versus pretransplant; P <0.05). Patients receiving dialysis therapy for 6 months or more prior to transplantation demonstrated lower SF-36 posttransplant physical component scores in comparison with patients who were transplanted preemptively (38 +/- 1 versus 45 +/- 2, P <0.05). Path analysis demonstrated the positive direct effect of time on FP with kidney transplantation (beta = 0.23, P <0.05), and the negative direct effects on FP of diabetes (beta = -0.22) and cadaveric organs (beta = -0.22, both P <0.05). In turn, FP had a positive direct effect on HRQOL (beta = 0.40, P <0.001)., Conclusions: Overall improvement in FP is attenuated 1 year after kidney transplantation in recipients of organs from cadaveric donors. The positive effect of time after transplantation, and the negative effects of cadaveric organs and diabetes on posttransplant HRQOL, are indirect and are mediated by the direct effects of these variables on posttransplant FP.

Background: Health-related quality of life and functional performance are important outcome measures following heart transplantation. This study investigates the impact of pre-transplant functional performance and post-transplant rejection episodes, obesity and osteopenia on post-transplant health-related quality of life and functional performance., Methods: Functional performance and health-related quality of life were measured in 70 adult heart transplant recipients. A composite health-related quality of life outcome measure was computed via principal component analysis. Iterative, multiple regression-based path analysis was used to develop an integrated model of variables that affect post-transplant functional performance and health-related quality of life., Results: Functional performance, as measured by the Karnofsky scale, improved markedly during the first 6 months post-transplant and was then sustained for up to 3 years. Rejection Grade > or =2 was negatively associated with health-related quality of life, measured by Short Form-36 and reversed Psychosocial Adjustment to Illness Scale scores. Patients with osteopenia had lower Short Form-36 physical scores and obese patients had lower functional performance. Path analysis demonstrated a negative direct effect of obesity (beta = - 0.28, p < 0.05) on post-transplant functional performance. Post-transplant functional performance had a positive direct effect on the health-related quality of life composite score (beta = 0.48, p < 0.001), and prior rejection episodes grade > or =2 had a negative direct effect on this measure (beta = -0.29, p < 0.05). Either directly or through effects mediated by functional performance, moderate-to-severe rejection, obesity and osteopenia negatively impact health-related quality of life. These findings indicate that efforts should be made to devise immunosuppressive regimens that reduce the incidence of acute rejection, weight gain and osteopenia after heart transplantation.

Our aim was to examine the effects of hepatitis C virus (HCV) infection, a leading cause of end-stage liver disease, and its recurrence after liver transplantation on functional performance and health-related quality of life. Functional performance, liver function, and HCV recurrence were assessed longitudinally in 75 adult transplant recipients (28 with HCV). Quality of life was reported once after transplantation. Functional performance improved through year 2 (P < 0.001) and then declined in those with HCV, whereas the others remained stable (P = 0.05). Time had a positive effect (beta = 0.22, P = 0.05) and HCV infection had a negative effect (beta = -0.28, P = 0.01) on post-transplant functional performance. Educational level (beta = 0.24, P < 0.05) and recent functional performance (beta = 0.31, P = 0.01) had positive effects on quality of life. HCV recurrence was associated with relatively poorer pretransplant functional performance, a greater rate of improvement through month 3 (P < 0.05), and abnormal transaminase values between years 1 and 2 (P < 0.001). Rehospitalization for recurrent HCV was associated with reduced functional performance (P < 0.05). Functional performance improves with time following liver transplantation, but HCV infection exerts an opposing and comparably strong effect. Post-transplant functional performance, in turn, directly affects post-transplant quality of life. Severe, recurrent HCV illness is associated with reduced functional performance.

PurposeThe EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. However, the relationship between domain scores and functional outcomes remains unclear, leading to potential confusion about expectations after treatment. For instance, does a sexual function domain score of 80 mean that a patient can achieve erection sufficient for intercourse? Consequently we sought to determine the relationship between the domain score and the response to obtaining the best possible outcome for each question.Materials and methodsUsing data from the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study, a multicenter, prospective study of men diagnosed with localized prostate cancer, we analyzed 11,464 EPIC-26 questionnaires from a total of 2,563 men at baseline through 60 months of followup who were treated with robotic prostatectomy, radiotherapy or active surveillance. We dichotomized every item into its best possible outcome and assessed the percent of men at each domain score who achieved the best result.ResultsFor every EPIC-26 item the frequency of the best possible outcome was reported by domain score category. For example, a score of 80 to 100 on sexual function corresponded to 97% of men reporting erections sufficient for intercourse while at a score of 40 to 60 only 28% reported adequate erections. Also, at a score of 80 to 100 on the urinary incontinence domain 93% of men reported rarely or never leaking vs 6% at a score of 61 to 80.ConclusionsOur findings indicate a novel way to interpret EPIC-26 domain scores, demonstrating large variations in the percent of respondents reporting the best possible outcomes over narrow domain score differences. This information may be valuable when counseling men on treatment options.

Introduction The United States Department of Veterans Affairs (VA) National Transplant Program has made efforts to improve access by introducing Web-based referrals and telehealth. The aims of this study were to describe the programmatic implementation and evaluate the effectiveness of new technology on the timeliness to kidney transplant evaluation at a VA medical centre. Methods Between 1 January 2009 and 31 May 2016, 835 patients were approved for evaluation. Monthly data were summarized as: number of applications, median days to evaluation, and median percentage of evaluations that occurred within 30 days. Temporal trends were analysed using non-parametric comparisons of medians between three eras: Pre Web-based submission, Web-based submission, and Web-based submission with videoconference (VC) telehealth. Results The number of applications did not vary between eras ( p = 0.353). The median time to evaluation and the median percentage of patients with appointments within 30 days improved significantly in the Web-based submission with VC era when compared with the Web-based and Pre Web-based eras (37 vs. 260 and 116 days, respectively, p < 0.001; 100% vs. 8% and 0%, respectively, p < 0.001). Discussion We have been able to markedly improve the timeliness to kidney transplant waitlist evaluation with the addition of telehealth. [ABSTRACT FROM AUTHOR]

Background The effect of awarding MELD exception points for hepatocellular carcinoma ( HCC) on patient-reported outcomes ( PROs) is unknown. We evaluated the physical and mental health-related quality of life ( HRQOL) and symptoms of anxiety and depression in liver transplant recipients with HCC compared to patients without HCC. Methods The single-center sample measured PROs before and after transplant, which included 1521 multisurvey measurement points among 502 adults (67% male, 28% HCC, follow-up time: <1-131 months). Data were analyzed using multivariable mixed-effects models. Results Longitudinal PRO values did not differ between persons who received HCC exception points and those who did not have HCC. Patients with HCC who did not receive exception points had reduced physical HRQOL ( P=.016), a late decline in mental HRQOL, and delayed reduction in anxiety (time-by-outcome interaction P<.050) compared to patients with HCC who received exception points. Conclusion Transplant recipients who received HCC exception points had PROs that were comparable to those of patients without HCC, and reported better physical HRQOL and reduced symptoms of anxiety compared to patients with HCC who did not receive exception points. These analyses demonstrate the impact of HCC exception points on PROs, and may help inform policy regarding HCC exception point allocation. [ABSTRACT FROM AUTHOR]

Aims and objectives. To evaluate whether gender, age and their interaction affect health-related quality of life and overall health status following kidney transplantation. Background. Some investigators have examined the main effects of gender and/or age on health-related quality of life following kidney transplantation, but the potential interaction effect of these measures on this outcome has not been reported. Design. This was a cross-sectional, single-centre study, based in one US geographic area. Methods. Self-report survey data were provided by adult kidney transplant recipients using the SF-36 Health Survey (SF-36) and a visual analogue scale of overall health. SF-36 physical and mental component summary and individual scales and overall health were measured prospectively at one time point post-transplant. All adult patients were eligible to participate and rolling enrolment was employed. Statistical effects were tested using analysis of covariance (controlling for time post-transplant). Results. Subjects ( n = 138) included 66 women and 72 men. There were no effects of gender, age group, or their interaction on MCS or overall health scores (all p ≥ 0·12). Physical component summary scale data demonstrated: (i) a significant effect of gender ( p = 0·025); (ii) a statistically marginal effect of age group ( p = 0·068); and (iii) a statistically marginal gender by age group interaction effect ( p = 0·066). Women reported poorer scores on the SF-36 physical functioning ( p = 0·049), role physical ( p = 0·014) and bodily pain scales ( p = 0·028). There was an effect of age group on physical functioning ( p = 0·005), with younger patients reporting higher scores. Conclusions. Women report lower scores on several physical measures and may experience a greater reduction with age in physical health-related quality of life than men. Physical functioning declines with age following kidney transplantation. Relevance to clinical practice. Findings may help healthcare professionals to develop gender- and age-specific interventions to optimize health-related quality of life of kidney transplant patients. [ABSTRACT FROM AUTHOR]

Feurer ID, Moore DE, Speroff T, Liu H, Payne J, Harrison C, Pinson CW. Refining a health-related quality of life assessment strategy for solid organ transplant patients. Clin Transplant 2004: 18 (Suppl. 12): 39–45. © Blackwell Munksgaard, 2004 The psychometric properties of generic health-related quality of life (HRQOL) assessment instruments were evaluated to identify a reliable, valid, and non-redundant battery to measure longitudinal outcomes in organ transplant patients. Objective functional performance and subjective HRQOL were assessed in 371 solid organ (liver, heart, kidney, lung) transplant patients using the Karnofsky scale, the SF-36® Health Survey (SF-36®), and Psychosocial Adjustment to Illness Scale (PAIS). The surveys' internal-consistency reliability, criterion-related validity, and redundancy were tested. The SF-36® mental (MCS) and physical components (PCS), and PAIS summary scales were internally consistent (all α ≥ 0.83). Four out of seven PAIS scales (vocational, domestic, sexual, social) were collectively associated with the PCS ( R = 0.65, P < 0.001), as was functional performance ( r = 0.52, P < 0.001). Three PAIS scales (family, social, psychological distress) were associated with the MCS ( R = 0.72, P < 0.001). Only the PAIS healthcare orientation (satisfaction) scale was not associated with the SF-36®. The relationship between functional performance and the PCS is stronger ( r = 0.52, P < 0.001) than with the MCS ( r = 0.25, P < 0.001) and the PAIS global score ( r = 0.37, P < 0.001). The SF-36® and PAIS are internally consistent and exhibit divergent criterion-related validity but, with the exception of the PAIS healthcare orientation scale, are statistically redundant. The advantages of the SF-36® include wider use, more norms, and a lesser response burden. A transplant-specific patient satisfaction inventory was indicated and was developed. [ABSTRACT FROM AUTHOR]

Our aim was to examine the effects of hepatitis C virus (HCV) infection, a leading cause of end-stage liver disease, and its recurrence after liver transplantation on functional performance and health-related quality of life. Functional performance, liver function, and HCV recurrence were assessed longitudinally in 75 adult transplant recipients (28 with HCV). Quality of life was reported once after transplantation. Functional performance improved through year 2 (P < 0.001) and then declined in those with HCV, whereas the others remained stable (P = 0.05). Time had a positive effect (β = 0.22, P = 0.05) and HCV infection had a negative effect (β = −0.28, P = 0.01) on post-transplant functional performance. Educational level (β = 0.24, P < 0.05) and recent functional performance (β = 0.31, P = 0.01) had positive effects on quality of life. HCV recurrence was associated with relatively poorer pretransplant functional performance, a greater rate of improvement through month 3 (P < 0.05), and abnormal transaminase values between years 1 and 2 (P < 0.001). Rehospitalization for recurrent HCV was associated with reduced functional performance (P < 0.05). Functional performance improves with time following liver transplantation, but HCV infection exerts an opposing and comparably strong effect. Post-transplant functional performance, in turn, directly affects post-transplant quality of life. Severe, recurrent HCV illness is associated with reduced functional performance. ( J Gastrointest Surg 2002;6:108–115.) [Copyright &y& Elsevier]

Background: Controversy exists regarding the optimal timing of repair after iatrogenic bile duct injuries (BDI). Several studies advocate late repair (≥6 weeks after injury) with mandatory drainage and resolution of inflammation. Others indicate that early repair (<6 weeks after injury) produces comparable or superior clinical outcomes. Additionally, although most studies have reported inferior outcomes with primary surgeon repair, this practice continues. With disparate published recommendations and rising health care costs, decision analysis was used to examine the cost-effectiveness of BDI repair. Study Design: A Markov model was developed to evaluate primary surgeon repair (PSR), late repair by a hepatobiliary surgeon (LHBS), and early repair by a hepatobiliary surgeon (EHBS). Baseline values and ranges were collected from the literature. Sensitivity analsyses were conducted to test the strength of the model and variability of parameters. Results: The model demonstrated that EHBS was associated with lower costs, earlier return to normal activity, and better quality of life. Specifically, 1 year after repair, PSR yielded 0.53 quality adjusted life years (QALYs) ($120,000/QALY) and LHBS yielded 0.74 QALYs ($74,000/QALY); EHBS yielded 0.82 QALYs ($48,000/QALY). Sensitivity analyses supported these findings at clinically meaningful probabilities. Conclusions: This cost-effectiveness model demonstrates that early repair by a hepatobiliary surgeon is the superior strategy for the treatment of BDI in properly selected patients. Although there is little clinical difference between early and late repair, there is a great difference in cost and quality of life. Ideally, costs and quality of life should be considered in decisions regarding strategies of repair of injured bile ducts. [ABSTRACT FROM AUTHOR]