C. Wright Pinson

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 definitive therapy for end-stage liver disease is hepatic transplant. In 2006, 6650 hepatic transplants were performed in the United States, which is an almost 4-fold increase since 1988.¹ Improvements in surgical technique, preoperative and postoperative care, immunosuppression regimens, antibiotics, organ preservation and allocation, and increasing demand have contributed to its rise. Improved survival has led to the increased importance of incorporating health-related quality of life (HRQOL) measures into a comprehensive outcomes assessment strategy as it may influence decisions involving organ transplant.

Objectives To determine whether patients with a complete or near-complete response to neoadjuvant radiation therapy (XRT) have improved survival compared with those with less of a response and to compare survival between patients with disease downstaged after neoadjuvant XRT and patients with stage I disease undergoing resection alone. Design, Setting, and Patients Retrospective cohort of 10 971 patients (3760 patients with neoadjuvant XRT; 7211 with stage I disease with resection alone) from the Surveillance, Epidemiology, and End Results registry using data from January 1, 1994, through December 31, 2003. Main Outcome Measures Overall survival and disease-specific survival (DSS) of patients undergoing resection for nonmetastatic rectal adenocarcinoma receiving neoadjuvant XRT and patients with stage I disease undergoing surgical resection alone. Results The 5-year DSS and overall survival were 94% and 82%, respectively, for responders to neoadjuvant XRT, 78% and 60%, respectively, for nonresponders, and 97% and 79%, respectively, for patients with stage I disease undergoing resection alone. Responders had improved DSS (P < .001) and overall survival (P < .001) compared with nonresponders by Cox regression. Patients with stage I disease undergoing resection alone had improved DSS (P = .01) but not overall survival (P = .89) compared with XRT responders. Conclusions Patients with rectal adenocarcinoma downstaged after neoadjuvant XRT have improved survival compared with nonresponders. While DSS is excellent for responders to neoadjuvant XRT, it did not equal the DSS of patients with stage I disease undergoing resection alone.

The impact of blood loss during liver transection and the need for perioperative blood transfusions have previously been shown to negatively impact perioperative morbidity and mortality as well as long-term outcomes [ 1 x [1] Kooby, D.A., Stockman, J., Ben-Porat, L., Gonen, M., Jarnagin, W.R., and Dematteo, R.P. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg. 2003; 237: 860–869 PubMed | Google Scholar See all References , 2 x [2] Sitzmann, J.V. and Greene, P.S. Perioperative predictors of morbidity following hepatic resection for neoplasm. A multivariate analysis of a single surgeon experience with 105 patients. Ann Surg. 1994; 219: 13–17 Crossref | PubMed | Scopus (155) | Google Scholar See all References , 3 x [3] Yamamoto, J., Kosuge, T., Takayama, T., Shimada, K., Yamasaki, S., and Ozaki, H. Perioperative blood transfusion promotes recurrence of hepatocellular carcinoma after hepatectomy. Surg. 1994; 115: 303–309 PubMed | Google Scholar See all References ]. Therefore, several “technological” advances over the past decades have focused on ways of decreasing blood loss during parenchymal transection [ 4 x [4] Cherqui, D., Husson, E., Hammoud, R., Melassagne, B., Stephan, F., and Bensaid, S. Laparoscopic liver resections: a feasibility study in 30 patients. Ann Surg. 2000; 232: 753–762 Crossref | PubMed | Scopus (407) | Google Scholar See all References , 5 x [5] Horgan, P.G. A novel technique for parenchymal division during hepatectomy. Am J Surg. 2001; 181: 236–237 Abstract | Full Text | Full Text PDF | PubMed | Scopus (81) | Google Scholar See all References , 6 x [6] Kaneko, H., Otsuka, Y., Takagi, S., Tsuchiya, M., Tamura, A., and Shiba, T. Hepatic resection using stapling devices. Am J Surg. 2004; 187: 280–284 Abstract | Full Text | Full Text PDF | PubMed | Scopus (46) | Google Scholar See all References , 7 x [7] Nagano, Y., Matsuo, K., Kunisaki, C., Ike, H., Imada, T., and Tanaka, K. Practical usefulness of ultrasonic surgical aspirator with argon beam coagulation for hepatic parenchymal transection. World J Surg. 2005; 29: 899–902 Crossref | PubMed | Scopus (22) | Google Scholar See all References , 8 x [8] Romano, F., Franciosi, C., Caprotti, R., Uggeri, F., and Uggeri, F. Hepatic surgery using the Ligasure vessel sealing system. World J Surg. 2005; 29: 110–112 Crossref | PubMed | Scopus (84) | Google Scholar See all References , 9 x [9] Weber, J.C., Navarra, G., Jiao, L.R., Nicholls, J.P., Jensen, S.L., and Habib, N.A. New technique for liver resection using heat coagulative necrosis. Ann Surg. 2002; 236: 560–563 Crossref | PubMed | Scopus (226) | Google Scholar See all References ]. These techniques share the same objectives: rapid division of hepatic parenchyma, minimization of blood loss, sealing of bile ducts to prevent postoperative biliary leaks, and avoidance of unintended damage to adjacent structures. Each of these techniques used for the division of hepatic parenchyma comes with unique sets of advantages and disadvantages.

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. 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. 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 and published reports were synthesized for descriptive and illustrative purposes. 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.

Liver transplantation (LT) has become an effective and widely accepted treatment for hepatocellular carcinoma (HCC), providing good long-term disease-free and overall survival as appropriate criteria evolved to select patients. The indications for LT have also developed for less common hepatic tumors, achieving acceptable results, perhaps surrounded by more controversy and evolving later. These other malignancies including cholangiocarcinoma, hepatoblastoma, hepatic epithelioid hemangioendothelioma, angiosarcoma, and metastasis from neuroendocrine tumors, all of which are the topic of this article, occur more frequently in non-cirrhotic liver than HCC. This fact sometimes makes obtaining a graft at an appropriate time from an oncologic point of view more difficult than for HCC. Understanding treatment options, the pathology of various tumors, the tumor stage, size, number and location, the patient's underlying condition, and the resources available are keys to selecting the optimal treatment choice for each patient. This article focuses on the transplantation option.

Liver transplantation remains a complex procedure with potential for significant patient morbidity, not only in the perioperative period, but also over the life of the graft. Biliary complications occur in 10–30% of recipients after liver transplantation ¹ x [1] Wise, P.E. and Pinson, C.W. Biliary complications of liver transplantation. in: Clavien P.A., Baillie J. (Eds.) Diseases of the gallbladder and bile ducts: diagnosis and treatment. Blackwell Science, ; 2001: 245–257 Google Scholar See all References ^{, 2} x [2] Fleck, A., Zanotelli, M.L., Meine, M., Brandao, A., Leipnitz, I., Schlindwein, E. et al. Biliary tract complications after orthotopic liver transplantation in adult patients. Transplant Proc. 2002; 34: 519–520 Abstract | Full Text | Full Text PDF | PubMed | Scopus (18) | Google Scholar See all References ^{, 3} x [3] Krawczyk, M., Nyckowski, P., Zieniewicz, K., Pawlak, J., Michalowicz, B., Malkowski, P. et al. Biliary complications following liver transplantation. Transplant Proc. 2000; 32: 1429–1431 Abstract | Full Text | Full Text PDF | PubMed | Scopus (11) | Google Scholar See all References ^{, 4} x [4] Hernandez, Q., Ramirez, P., Munitiz, V., Pinero, A., Robles, R., Sanchez‐Bueno, F. et al. Incidence and management of biliary tract complications following 300 consecutive orthotopic liver transplants. Transplant Proc. 1999; 31: 2407–2408 Abstract | Full Text | Full Text PDF | PubMed | Scopus (27) | Google Scholar See all References . Prevention of biliary complications has focused on efforts to diminish tissue ischemia. Techniques such as the cholecystocholedochostomy, side‐to‐side choledochocholedochostomy popularized by Neuhaus ⁵ x [5] Neuhaus, P., Blumhardt, G., Bechstein, W.O., Steffen, R., Platz, K.P., and Keck, H. Technique and results of biliary reconstruction using side‐to‐side choledochocholedochostomy in 300 orthotopic liver transplants. Ann Surg. 1994; 219: 426–434 Crossref | PubMed | Scopus (158) | Google Scholar See all References , and end‐to‐end choledochocholedochostomy with shortened ducts have been used to ameliorate the risk of biliary ischemia and resultant complications such as leak or stricture.

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.