Design, development and validation of a system for automatic help to medical text understanding.

OBJECTIVE: The paper presents a web-based application, SIMPLE, that facilitates medical text comprehension by identifying the health-related terms of a medical text and providing the corresponding consumer terms and explanations. BACKGROUND: The comprehension of a medical text is often a difficult task for laypeople because it requires semantic abilities that can differ from a person to another, depending on his/her health-literacy level. Some systems have been developed for facilitating the comprehension of medical texts through text simplification, either syntactical or lexical. The ones dealing with lexical simplification usually replace the original text and do not provide additional information. We have developed a system that provides the consumer terms alongside the original medical terms and also adds consumer explanations. Moreover, differently from other solutions, our system works with multiple languages. METHODS: We have developed the SIMPLE application that is able to automatically: 1) identify medical terms in a medical text by using medical vocabularies; 2) translate the medical terms into consumer terms through medical-consumer thesauri; 3) provide term explanations by using health-consumer dictionaries. SIMPLE can be used as a standalone web application or can it be embedded into common health platforms for real time identification and explanation of medical terms. At present, it works with English and Italian texts but it can be easily extended to other languages. We have run subjective tests with both medical experts and non-experts as well as objective tests to verify the effectiveness of SIMPLE and its simplicity of use. RESULTS: Non-experts found SIMPLE easy to use and responsive. The big majority of respondents confirmed they were helped by SIMPLE in understanding medical texts and declared their willingness to continue using SIMPLE and to recommend it to other people. The subjective tests, conducted with medical experts on a set of Italian radiology reports, showed an agreement between SIMPLE and the experts, on the highlighted medical terms, that ranges between 74.05 % and 81.16 % as well as an agreement of around 60 % on the consumer term translation. The objective tests showed that the consumer terms, provided by SIMPLE, are, on average, eighteen times more familiar than the relative medical terms so proving, once more, the effectiveness of SIMPLE in simplifying the medical terms. CONCLUSIONS: The performed tests demonstrate the effectiveness of SIMPLE, its simplicity of use and the willingness of people in continuing with its use. SIMPLE provides, with a good agreement level, the same information that medical experts would provide. Finally, the consumer terms are 'objectively' more familiar than the related technical terms and as a consequence, much easier to understand.

Service quality benchmarking via a novel approach based on fuzzy ELECTRE III and IPA: an empirical case involving the Italian public healthcare context.

A novel fuzzy-based approach which combines ELECTRE III along with the Importance-Performance Analysis (IPA) is proposed in the present work to comparatively evaluate the service quality in the public healthcare context. Specifically, ELECTRE III is firstly considered to compare the service performance of examined hospitals in a noncompensatory manner. Afterwards, IPA is employed to support the service quality management to point out improvement needs and their priorities. The proposed approach also incorporates features of the Fuzzy Set Theory so as to address the possible uncertainty, subjectivity and vagueness of involved experts in evaluating the service quality. The model is applied to five major Sicilian public hospitals, and strengths and criticalities of the delivered service are finally highlighted and discussed. Although several approaches combining multi-criteria methods have already been proposed in the literature to evaluate the service performance in the healthcare field, to the best of the authors' knowledge the present work represents the first attempt at comparing service performance of alternatives in a noncompensatory manner in the investigated context.

A quality risk management model approach for cell therapy manufacturing.

International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell-based therapies in regenerative medicine. The available risk management guidelines, however, provide little guidance on specific risk analysis approaches and procedures applicable in clinical cell therapy manufacturing. This raises a number of problems. Cell manufacturing is a poorly automated process, prone to operator-introduced variations, and affected by heterogeneity of the processed organs/tissues and lot-dependent variability of reagent (e.g., collagenase) efficiency. In this study, the principal challenges faced in a cell-based product manufacturing context (i.e., high dependence on human intervention and absence of reference standards for acceptable risk levels) are identified and addressed, and a risk management model approach applicable to manufacturing of cells for clinical use is described for the first time. The use of the heuristic and pseudo-quantitative failure mode and effect analysis/failure mode and critical effect analysis risk analysis technique associated with direct estimation of severity, occurrence, and detection is, in this specific context, as effective as, but more efficient than, the analytic hierarchy process. Moreover, a severity/occurrence matrix and Pareto analysis can be successfully adopted to identify priority failure modes on which to act to mitigate risks. The application of this approach to clinical cell therapy manufacturing in regenerative medicine is also discussed.

Comparison of two different techniques of reperfusion in adult orthotopic liver transplantation.

UNLABELLED: The aim of this study was to determine the impact of two reperfusion techniques on the peri-operative hemodynamic changes and early post-operative graft function of adult patients undergoing orthotopic liver transplantation. MATERIAL AND METHODS: From June 2003 to May 2004, 50 consecutive liver transplants were performed and divided into two groups: group A, 25 patients, portal vein flush with 500 cm(3) of Ringer's lactate without vena caval venting. Group B, 25 patients, vena caval venting with no portal vein flush. Donor and recipient characteristics were similar in both groups. Sixty-four different parameters were analyzed, and Pearson's chi(2) test and t-test were used for statistical analysis, p

Significance of the effective remnant liver volume in major hepatectomies.

The aim of this study is to identify the minimum safe amount of effective remnant liver volume (ERLV) in patients undergoing a major hepatectomy. Thirty-eight consecutive major hepatectomies (resection of > or = 3 Couinaud segments) performed between July 1999 and March 2004 in which a frozen section liver biopsy was obtained were included. No patient had chronic viral hepatitis, cirrhosis, or cholestasis. The total liver volume (TLV) was calculated using the Vauthey formula, and the postsurgical liver volume (PSLV) was derived by subtracting the estimated volume of liver resected from the TLV. The PSLV minus the percentage of macrovesicular steatosis as nonfunctional liver was defined as the effective remnant liver volume (ERLV). Three groups of ERLV/TLV ratios (<30%, between 30% and 60%, and >60%) were correlated with liver resection type, mortality, complications, intraoperative blood transfusions, operative time, length of hospitalization, and mean value of liver function tests in the first 5 postoperative days. Comparisons between clinical parameters were performed by Pearson chi2 test. There was significant correlation between ERLV/TLV ratios and surgical resection type (P < 0.001), early postoperative mortality (P < 0.01), and complications (P < 0.003). The ERLV/TLV ratio may be a useful predictor of surgical outcome after major hepatectomy.

Efficacy and safety of basiliximab with a tacrolimus-based regimen in liver transplant recipients.

BACKGROUND: Induction with monoclonal antibodies for prevention of acute cellular rejection (ACR) may avoid many of the adverse events associated with polyclonal antibodies. Basiliximab, a chimeric monoclonal antibody directed against the alpha-chain of the interleukin 2 receptor (CD25), has been extensively evaluated as an induction therapy for kidney transplant recipients, more frequently in combination with a cyclosporine-based regimen. In this study, we assessed the efficacy and safety of basiliximab in combination with a tacrolimus-based regimen after liver transplantation. METHODS: Fifty consecutive liver transplants (47 cadaveric donors; 3 living donors) were analyzed. All patients received two 20-mg doses of basiliximab (days 0 and 4 after transplantation) followed by tacrolimus (0.15 mg/kg/day; 10-15 ng/mL target trough levels) and a tapered dose regimen of steroids. Follow-up ranged from 404 to 1,364 days after transplantation (mean 799.89 days, SD+/-257.37; median 796 days). RESULTS: A total of 88% of patients remained rejection-free during follow-up with an actuarial rejection-free probability of 75% within 3 months. The actuarial patient survival rate at 3 years was 88%, and the graft survival rate was 75%. Twelve (24%) patients experienced one episode of sepsis, requiring temporary reduction of immunosuppressive therapy. There were no immediate side effects associated with basiliximab and no evidence of cytomegalovirus infection or posttransplant lymphoproliferative disorder. CONCLUSIONS: Basiliximab in combination with a tacrolimus-based immunosuppressive regimen is effective in reducing episodes of ACR and increasing ACR-free survival after liver transplantation. In addition, basiliximab does not increase the incidence of adverse effects or infections.