Informatics and evidence-based medicine: prescription for success.

This article reports on the experience of one organization between 2004 and 2009 to develop an effective people-process-technology system to better manage the quality of health care. The creation of this system started with creating a strategic plan for quality and then establishing a structure to implement the plan. The next phase consisted of establishing a number of simultaneous steps that ranged from identifying and leveraging the appropriate informatics tools to the oversight process, and from the implementation team to strategies for working with clinical groups. The outcome as of 2009 is a well established evidence-based quality process and team in place. There are over 450 evidence-based medicine quality sets. More than 52% of all patients are admitted on quality evidence-based medicine pathways and protocols. This article reflects a successful prescription for combining informatics and evidence-based medicine to improve the quality of health care.

The negative effect of pretransplant overweight and obesity on the rate of improvement in physical quality of life after liver transplantation.

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.

The effects of gender and age on health-related quality of life following kidney transplantation.

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.

Biliary reconstruction using non-penetrating, tissue everting clips versus conventional sewn biliary anastomosis in liver transplantation.

BACKGROUND: Biliary complications occur following approximately 25% of liver transplantations. Efforts to decrease biliary complications include methods designed to diminish tissue ischemia. Previously, we reported excellent short-term results and decreased biliary anastomosis time in a porcine liver transplant model using non-penetrating, tissue everting clips (NTEC), specifically VCS clips. METHODS: We examined the incidence of biliary anastomotic complications in a group of patients in whom orthotopic liver transplantation was performed with biliary reconstruction using NTEC and compared that group to a matched group treated with biliary reconstruction via conventional end-to-end sewn choledochocholedochostomy. Patients were matched in a 1:2 fashion by age at transplantation, disease etiology, Child-Turcot-Pugh scores, MELD score or UNOS status (prior to 1998), cold and warm ischemia times, organ donor age, and date of transplantation. RESULTS: Seventeen patients had clipped anastomosis and 34 comparison patients had conventional sewn anastomosis. There were no differences between groups in terms of baseline clinical or demographic data. The median time from completion of the hepatic artery anastomosis to completion of clipped versus conventional sewn biliary anastomosis was 45 (interquartile range = 20 min) versus 47 min (interquartile range = 23 min), respectively (p=0.12). Patients were followed for a mean of 29 months. Biliary anastomotic complications, including leak or anastomotic stricture, were observed in 18% of the clipped group and 24% of the conventional sewn group. CONCLUSIONS: Biliary reconstruction can be performed clinically using NTEC as an alternative to conventional sewn biliary anastomoses with good results.

Survival and functional quality of life after resection for hepatic carcinoid metastasis.

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.

Fluorescence spectroscopy accurately detects irreversible cell damage during hepatic radiofrequency ablation.

BACKGROUND: A current limitation of hepatic radiofrequency ablation (RFA) is an inability to detect ablation margins in real time. Thermal injury from RFA alters the biochemical properties governing tissue fluorescence. We hypothesized that the changes in hepatic fluorescence measured during hepatic RFA could be used to detect irreversible hepatocyte damage accurately and to determine ablation margins in real time. METHODS: RFA was performed on healthy pig livers and monitored in vivo simultaneously for fluorescence and temperature by a fiberoptic micro-interrogation probe connected to a spectroscopy system. Ablations were stopped based on previously established real-time fluorescence spectral data, not based on temperature or time. To determine where in the ablated tissue cell death occurred, biopsies for transmission electron microscopy were taken from 4 areas of 3 specimens: (1) nonablated liver, (2) hemorrhagic zone/normal liver interface, (3) hemorrhagic zone/coagulated zone interface, and (4) coagulated zone. In vitro fluorescence emission intensity was determined at each biopsy site. RESULTS: Peak hepatic fluorescence intensity occurred at 470 nm and decreased as RFA progressed. Transmission electron microscopy evidence of irreversible hepatocyte damage occurred at the interface of the coagulation zone and the hemorrhagic zone and correlated with a 87.5% +/- 9% decrease in fluorescence emission intensity. Tissue fluorescent changes from thermal injury were unaffected by tissue cooling. CONCLUSION: Fluorescence spectroscopy accurately detected hepatocellular thermal injury from RFA in real time and can detect irreversible cell damage during tissue thermal therapy.

Health-related quality of life before and after solid organ transplantation. Measurement consideration, reported outcomes, and future directions.

The initial focus in organ transplantation clinical research was demonstrating acceptable technical and survival outcomes. Both patient and graft survival have reached well-documented, laudable levels, and solid organ (liver, heart, kidney, lung) transplantation procedures are now relatively common. As with any complex medical procedure that entails relatively high risk, financial costs, and life-long follow-up care, reliable and valid assessments of the "quality" of the extended life years are of interest to patients, their families, policy makers, and payers. This review focuses on health-related quality of life (HRQOL) and functional performance in adults following solid organ transplantation, with an emphasis on: 1) instruments and methods; 2) outcomes in liver, heart, kidney, and lung transplant recipients; and 3) future research directions. Practical considerations for developing longitudinal HRQOL assessment strategies are reviewed. The current emphasis on modeling demographic and clinical factors that promote or limit optimal HRQOL is illustrated. These lines of research will help identify potential interventions designed to promote better HRQOL in organ transplant recipients.

Hepatic cryoablation, but not radiofrequency ablation, results in lung inflammation.

OBJECTIVE: To compare the effects of 35% hepatic cryoablation with a similar degree of radiofrequency ablation (RFA) on lung inflammation, nuclear factor kappaB (NF-kappaB) activation, and production of NF-kappaB dependent cytokines. SUMMARY BACKGROUND DATA: Multisystem injury, including acute lung injury, is a severe complication associated with hepatic cryoablation of 30% to 35% or more of liver parenchyma, but this complication has not been reported with RFA. METHODS: Sprague-Dawley rats underwent 35% hepatic cryoablation or RFA and were killed at 1, 2, and 6 hours. Liver and lung tissue were freeze-clamped for measurement of NF-kappaB activation, which was detected by electrophoretic mobility shift assay. Serum concentrations of tumor necrosis factor alpha and macrophage inflammatory protein 2 were measured by enzyme-linked immunosorbent assay. Histologic studies of pulmonary tissue and electron microscopy of ablated liver tissue were compared among treatment groups. RESULTS: Histologic lung sections after cryoablation showed multiple foci of perivenular inflammation, with activated lymphocytes, foamy macrophages, and neutrophils. In animals undergoing RFA, inflammatory foci were not present. NF-kappaB activation was detected at 1 hour in both liver and lung tissue samples of animals undergoing cryoablation but not after RFA, and serum cytokine levels were significantly elevated in cryoablation versus RFA animals. Electron microscopy of cryoablation-treated liver tissue demonstrated disruption of the hepatocyte plasma membrane with extension of intact hepatocyte organelles into the space of Disse; RFA-treated liver tissue demonstrated coagulative destruction of hepatocyte organelles within an intact plasma membrane. To determine the stimulus for systemic inflammation, rats treated with cryoablation had either immediate resection of the ablated segment or delayed resection after a 15-minute thawing interval. Immediate resection of the cryoablated liver tissue prevented NF-kappaB activation and lung injury; however, pulmonary inflammatory changes were present when as little as a 15-minute thaw interval preceded hepatic resection. CONCLUSIONS: Hepatic cryoablation, but not RFA, induces NF-kappaB activation in the nonablated liver and lung and is associated with acute lung injury. Lung inflammation is associated with the thawing phase of cryoablation and may be related to soluble mediator(s) released from the cryoablated tissue. These findings correlate the clinical observation of an increased incidence of multisystem injury, including adult respiratory distress syndrome (ARDS), after cryoablation but not RFA.