Solid Organ Transplant Recipients Exhibit More TET2-Mutant Clonal Hematopoiesis of Indeterminate Potential Not Driven by Increased Transplantation Risk.

PURPOSE: Solid organ transplant recipients comprise a unique population of immunosuppressed patients with increased risk of malignancy, including hematologic neoplasms. Clonal hematopoiesis of indeterminate potential (CHIP) represents a known risk factor for hematologic malignancy and this study describes the prevalence and patterns of CHIP mutations across several types of solid organ transplants. EXPERIMENTAL DESIGN: We use two national biobank cohorts comprised of >650,000 participants with linked genomic and longitudinal phenotypic data to describe the features of CHIP across 2,610 individuals who received kidney, liver, heart, or lung allografts. RESULTS: We find individuals with an allograft before their biobank enrollment had an increased prevalence of TET2 mutations (OR, 1.90; P = 4.0e-4), but individuals who received transplants post-enrollment had a CHIP mutation spectrum similar to that of the general population, without enrichment of TET2. In addition, we do not observe an association between CHIP and risk of incident transplantation among the overall population (HR, 1.02; P = 0.91). And in an exploratory analysis, we do not find evidence for a strong association between CHIP and rates of transplant complications such as rejection or graft failure. CONCLUSIONS: These results demonstrate that recipients of solid organ transplants display a unique pattern of clonal hematopoiesis with enrichment of TET2 driver mutations, the causes of which remain unclear and are deserving of further study.

Developing an Implementation Strategy for Systematic Measurement of Patient-Reported Outcomes at an Academic Health Center.

EXECUTIVE SUMMARY: Patient-reported outcome measures (PROMs) are used in research and have the potential to improve clinical care. We sought to develop a strategy for integrating PROMs into routine clinical care at an academic health center. The implementation strategy consisted of three phases. The first, exploratory phase, focused on engaging leadership and conducting an inventory of current efforts to collect PROMs. The inventory revealed 87 patient-reported outcome efforts, 47 of which used validated PROMs (62% for research, 21% for clinical care, 17% for quality). In the second, preparatory phase, we identified three pilot implementation sites chosen with facilitators determined in the exploratory phase. Using data from local needs assessments at the pilot sites, we constructed a timeline for inclusion of PROM efforts across the clinical enterprise. In the third phase, we adapted a technology platform for capturing PROMs using the electronic health record and began implementing this platform at the pilot sites. We found that integrating PROMs into routine clinical practice is highly complex. This complexity necessitates change management at the enterprise level.

Long-Term Physical HRQOL Decreases After Single Lung as Compared With Double Lung Transplantation.

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.

Increasing kidney donor profile index sequence does not adversely affect medium-term health-related quality of life after kidney transplantation.

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.

Patient-reported outcomes in liver transplant recipients with hepatocellular carcinoma.

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.

Validation of the Written Administration of the Short Literacy Survey.

Most health literacy assessments are time consuming and administered verbally. Written self-administration of measures may facilitate more widespread assessment of health literacy. This study aimed to determine the intermethod reliability and concurrent validity of the written administration of the 3 subjective health literacy questions of the Short Literacy Survey (SLS). The Rapid Estimate of Adult Literacy in Medicine (REALM) and the shortened test of Functional Health Literacy in Adults (S-TOFHLA) were the reference measures of health literacy. Two hundred ninety-nine participants completed the written and verbal administrations of the SLS from June to December 2012. Intermethod reliability was demonstrated when (a) the written and verbal SLS score did not differ and (b) written and verbal scores were highly correlated. The written items were internally consistent (Cronbach's α = .733). The written total score successfully identified persons with sixth-grade equivalency or less for literacy on the REALM (AUROC = 0.753) and inadequate literacy on the S-TOFHLA (AUROC = 0. 869). The written administration of the SLS is reliable, valid, and is effective in identifying persons with limited health literacy.

The long-term effect of bile duct injuries on health-related quality of life: a meta-analysis.

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.

Is liver transplantation using organs donated after cardiac death cost-effective or does it decrease waitlist death by increasing recipient death?

OBJECTIVES: The aim of this study was to evaluate the cost-effectiveness in liver transplantation (LT) of utilizing organs donated after cardiac death (DCD) compared with organs donated after brain death (DBD). METHODS: A Markov-based decision analytic model was created to compare two LT waitlist strategies distinguished by organ type: (i) DBD organs only, and (ii) DBD and DCD organs. The model simulated outcomes for patients over 10 years with annual cycles through one of four health states: survival; ischaemic cholangiopathy; retransplantation, and death. Baseline values and ranges were determined from an extensive literature review. Sensitivity analyses tested model strength and parameter variability. RESULTS: Overall survival is decreased, and biliary complications and retransplantation are increased in recipients of DCD livers. Recipients of DBD livers gained 5.6 quality-adjusted life years (QALYs) at a cost of US$69 000/QALY, whereas recipients on the DBD + DCD LT waitlist gained 6.0 QALYs at a cost of US$61 000/QALY. The DBD + DCD organ strategy was superior to the DBD organ-only strategy. CONCLUSIONS: The extension of life and quality of life provided by DCD LT to patients on the waiting list who might otherwise not receive a liver transplant makes the continued use of DCD livers cost-effective.

Negative effects of pretransplant body mass index on physical health-related quality of life after lung transplant.

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 (ß = -.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.

Comparison of open live donor nephrectomy, laparoscopic live donor nephrectomy, and hand-assisted live donor nephrectomy: a cost-minimization analysis.

BACKGROUND: Live donor kidney transplantation is the treatment of choice for end-stage renal disease. Open donor nephrectomy (ODN) was the standard until the introduction of the laparoscopic donor nephrectomy (LDN) in 1995. Hand-assisted laparoscopic donor nephrectomy (HALDN) was added shortly thereafter. The laparoscopic techniques are associated with increased operating room times and equipment costs; however, these techniques speed patient return to normal activity. The aim of this study is to evaluate the cost of these techniques. MATERIALS AND METHODS: A decision analysis model was developed to simulate outcomes for donors undergoing ODN, LDN, and HALDN. Outcomes were simulated from both the institutional perspective (IP) and the societal perspective (SP). Baseline values and ranges were determined from a systematic review of the literature. Sensitivity analyses were conducted to test model strength. RESULTS: From the IP, ODN is the least costly strategy with a cost of $11,000, while the cost is $15,200 for HALDN and $15,800 for LDN. From the SP, HALDN is the least costly strategy costing $27,800, while the cost for LDN is $29,000 and for ODN is $41,000. In sensitivity analysis, ODN only became the dominant strategy if the days till return to work exceeded 58 in the HALDN strategy. LDN and HALDN were nearly equivalent as the rate of open conversion of LDN approached zero. CONCLUSIONS: HALDN is the least costly donor nephrectomy strategy, especially from the SP. The primary determinants of cost in this model are conversion to open and days till return to work.

A cost-effectiveness analysis of early vs late reconstruction of iatrogenic bile duct injuries.

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.

An urban-rural blight? Choledocholithiasis presentation and treatment.

BACKGROUND: Exploration of urban-rural (UR) and regional differences is critical to developing effective healthcare delivery systems. Choledocholithiasis (CDL) remains a common problem with a range of therapeutic options and potentially severe complications. This study evaluated UR and regional differences of CDL presentation and treatment. We hypothesized that UR status contributes to differences in treatment of CDL. METHODS: This study examined patients from the 2007 Healthcare Cost and Utilization Project dataset. Inpatient discharges and interventions for CDL patients were identified. UR and regional designations were determined from National Center for Health Statistics guidelines. Patients with pancreatitis or cholangitis were designated as complicated CDL (cCDL) patients. Interventions for CDL were classified as endoscopic, surgical, or percutaneous. Complex-sample proportion analyses were performed. RESULTS: A total of 111,021 patients with CDL were identified; 81% of these patients lived in urban areas compared with 19% in rural areas; 61% had uncomplicated choledocholithiasis (uCDL) and 39% had cCDL. The overall distribution of uCDL and cCDL did not differ by UR status or region. A higher proportion of rural patients did not receive an intervention 45.1% (95%CI 41.8%-48.4%) versus urban patients 30.5% (28.8%-32.2%), P < 0.05. Interventions for urban patients were more likely endoscopic 87.7% (86.8%-88.6%) compared with rural 82.0% (79.3%-84.7%), P < 0.05. Rural patients were more likely to undergo surgery 10.5% (8.6%-12.4%) than urban patients 4.9% (4.4%-5.4%), P < 0.05. Regional variations did not impact the type of intervention received. CONCLUSION: Rural patients received CDL interventions less often and had a higher proportion of surgical interventions regardless of severity of presentation.

Reduction in corticosteroids is associated with better health-related quality of life after liver transplantation.

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.

Which is more cost-effective under the MELD system: primary liver transplantation, or salvage transplantation after hepatic resection or after loco-regional therapy for hepatocellular carcinoma within Milan criteria?

OBJECTIVE: The optimal strategy for treating hepatocellular carcinoma (HCC), a disease with increasing incidence, in patients with Child-Pugh class A cirrhosis has long been debated. This study evaluated the cost-effectiveness of hepatic resection (HR) or locoregional therapy (LRT) followed by salvage orthotopic liver transplantation (SOLT) vs. that of primary orthotopic liver transplantation (POLT) for HCC within the Milan Criteria. METHODS: A Markov-based decision analytic model simulated outcomes, expressed in costs and quality-adjusted life years (QALYs), for the three treatment strategies. Baseline parameters were determined from a literature review. Sensitivity analyses tested model strength and parameter variability. RESULTS: Both HR and LRT followed by SOLT were associated with earlier recurrence, decreased survival, increased costs and decreased quality of life (QoL), whereas POLT resulted in decreased recurrence, increased survival, decreased costs and increased QoL. Specifically, HR/SOLT yielded 3.1 QALYs (at US$96 000/QALY) and LRT/SOLT yielded 3.9 QALYs (at US$74 000/QALY), whereas POLT yielded 5.5 QALYs (at US$52 000/QALY). Sensitivity analyses supported these findings at clinically meaningful probabilities. CONCLUSIONS: Under the Model for End-stage Liver Disease (MELD) system, in patients with HCC within the Milan Criteria, POLT increases survival and QoL at decreased costs compared with HR or LRT followed by SOLT. Therefore, POLT is the most cost-effective strategy for the treatment of HCC.

Health insurance status affects staging and influences treatment strategies in patients with hepatocellular carcinoma.

BACKGROUND: Lack of health insurance is associated with poorer outcomes for patients with cancers amenable to early detection. The effect of insurance status on hepatocellular carcinoma (HCC) presentation stage and treatment outcomes has not been examined. We examined the effect of health insurance status on stage of presentation, treatment strategies, and survival in patients with HCC. METHODS: The Tennessee Cancer Registry was queried for patients treated for HCC between January 2004 and December 2006. Patients were stratified by insurance status: (1) private insurance; (2) government insurance (non-Medicaid); (3) Medicaid; (4) uninsured. Logistic, Kaplan-Meier, and Cox models tested the effects of demographic and clinical covariates on the likelihood of having surgical or chemotherapeutic treatments and survival. RESULTS: We identified 680 patients (208 private, 356 government, 75 Medicaid, 41 uninsured). Uninsured patients were more likely to be men, African American, and reside in an urban area (all P < 0.05). The uninsured were more likely to present with stage IV disease (P = 0.005). After adjusting for demographics and tumor stage, Medicaid and uninsured patients were less likely to receive surgical treatment (both P < 0.01) but were just as likely to be treated with chemotherapy (P ≥ 0.243). Survival was significantly better in privately insured patients and in those treated with surgery or chemotherapy (all P < 0.01). Demographic adjusted risk of death was doubled in the uninsured (P = 0.005). CONCLUSIONS: Uninsured patients with HCC are more likely to present with late-stage disease. Although insurance status did not affect chemotherapy utilization, Medicaid and uninsured patients were less likely to receive surgical treatment.

Pre-transplant overweight and obesity do not affect physical quality of life after kidney transplantation.

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.

Ciliated hepatic foregut cysts in children.

Ciliated hepatic foregut cyst (CHFC) is a rare foregut developmental malformation usually diagnosed in adulthood; however, rare cases have been reported in the pediatric population. CHFC can transform into a squamous cell carcinoma resulting in death despite surgical resection of the isolated malignancy. We report the presentation, evaluation, and surgical management of a symptomatic 17-year-old girl found to have a 6.5 x 4.5 cm CHFC and suggest that all patients with suspected CHFC undergo prompt evaluation and complete cyst excision.

Exsanguination protocol improves survival after major hepatic trauma.

BACKGROUND: Hepatic injury remains an important cause of exsanguination after major trauma. Recent studies have noted a dramatic reduction in mortality amongst severely injured patients when trauma exsanguinations protocols (TEP) are employed. We hypothesised that utilisation of our institution's TEP at the initiation of hospital resuscitation would improve survival in patients with significant hepatic trauma. PATIENTS AND METHODS: All patients who (1) sustained intra-abdominal haemorrhage with Grades III-V hepatic injury and (2) underwent immediate operative intervention between February 2004 and January 2008 were included in the study. TEP was instituted in February 2006, and all subsequent patients who met inclusion criteria and were treated with TEP constituted the study group. Patients who met inclusion criteria, were treated before introduction of TEP, and received at least 10 units packed red blood cells in the first 24h constituted pre-TEP comparison group. Univariate and multivariate analyses evaluated the effects of TEP on the study population. RESULTS: Seventy-five patients were included in the study: 39 in the pre-TEP cohort (31% 30-day survival) and 36 in the TEP cohort (53% 30-day survival). There were no differences in demographics, extent of hepatic injury, or operative approach between the patient groups (all p > or = 0.27). Injury Severity Scores were significantly higher in the TEP group (41+/-18 vs. 28+/-15, p<0.01). TEP patients received more plasma and platelets during operative intervention and significantly less crystalloid (all p<0.01). Occurrence of cardiac dysfunction and abdominal compartment syndrome was significantly lower in TEP patients who survived 24-h post-injury (both p < or = 0.04). After adjusting for the significant negative effects of Grade V injury and involvement of major hepatic vasculature (both p < or = 0.02), TEP significantly improved 30-day survival: OR=0.22, 95% CI: 0.06-0.81, p=0.02. CONCLUSIONS: TEP allows for an effective use of plasma and platelets during intra-operative management of severe hepatic injury. Utilisation of TEP is associated with significant reductions of cardiac dysfunction and development of abdominal compartment syndrome, as well as, significant improvement in 30-day survival.

Effects of clinical factors on psychosocial variables in renal transplant recipients.

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 (