Hematopoietic stem cell transplantation in Switzerland: a comprehensive quality control report on centre effect

QUESTIONS UNDER STUDY / PRINCIPLES: Interest groups advocate centre-specific outcome data as a useful tool for patients in choosing a hospital for their treatment and for decision-making by politicians and the insurance industry. Haematopoietic stem cell transplantation (HSCT) requires significant infrastructure and represents a cost-intensive procedure. It therefore qualifies as a prime target for such a policy. METHODS: We made use of the comprehensive database of the Swiss Blood Stem Cells Transplant Group (SBST) to evaluate potential use of mortality rates. Nine institutions reported a total of 4717 HSCT - 1427 allogeneic (30.3%), 3290 autologous (69.7%) - in 3808 patients between the years 1997 and 2008. Data were analysed for survival- and transplantation-related mortality (TRM) at day 100 and at 5 years. RESULTS: The data showed marked and significant differences between centres in unadjusted analyses. These differences were absent or marginal when the results were adjusted for disease, year of transplant and the EBMT risk score (a score incorporating patient age, disease stage, time interval between diagnosis and transplantation, and, for allogeneic transplants, donor type and donor-recipient gender combination) in a multivariable analysis. CONCLUSIONS: These data indicate comparable quality among centres in Switzerland. They show that comparison of crude centre-specific outcome data without adjustment for the patient mix may be misleading. Mandatory data collection and systematic review of all cases within a comprehensive quality management system might, in contrast, serve as a model to ascertain the quality of other cost-intensive therapies in Switzerland.

Personalized therapy in pain management: where do we stand?

Genomic variations influencing response to pharmacotherapy of pain are currently under investigation. Drug-metabolizing enzymes represent a major target of ongoing research in order to identify associations between an individual's drug response and genetic profile. Polymorphisms of the cytochrome P450 enzymes (CYP2D6) influence metabolism of codeine, tramadol, hydrocodone, oxycodone and tricyclic antidepressants. Blood concentrations of some NSAIDs depend on CYP2C9 and/or CYP2C8 activity. Genomic variants of these genes associate well with NSAIDs' side effect profile. Other candidate genes, such as those encoding (opioid) receptors, transporters and other molecules important for pharmacotherapy in pain management, are discussed; however, study results are often equivocal. Besides genetic variants, further variables, for example, age, disease, comorbidity, concomitant medication, organ function as well as patients' compliance, may have an impact on pharmacotherapy and need to be addressed when pain therapists prescribe medication. Although pharmacogenetics as a diagnostic tool has the potential to improve patient therapy, well-designed studies are needed to demonstrate superiority to conventional dosing regimes.

The role of choline positron emission tomography/computed tomography in the management of patients with prostate-specific antigen progression after radical treatment of prostate cancer

Choline positron emission tomography (PET)/computed tomography (CT) is a currently used diagnostic tool in restaging prostate cancer (PCa) patients with increasing prostate-specific antigen (PSA) after either radical prostatectomy (RP) or external-beam radiation therapy (EBRT). However, no final recommendations have been made on the use of this modality for patient management.

Randomized trial of a computerized coronary heart disease risk assessment tool in HIV-infected patients receiving combination antiretroviral therapy

Exposure to combination antiretroviral therapy (cART) can lead to important metabolic changes and increased risk of coronary heart disease (CHD). Computerized clinical decision support systems have been advocated to improve the management of patients at risk for CHD but it is unclear whether such systems reduce patients' risk for CHD.

SMARTDIAB: a communication and information technology approach for the intelligent monitoring, management and follow-up of type 1 diabetes patients

SMARTDIAB is a platform designed to support the monitoring, management, and treatment of patients with type 1 diabetes mellitus (T1DM), by combining state-of-the-art approaches in the fields of database (DB) technologies, communications, simulation algorithms, and data mining. SMARTDIAB consists mainly of two units: 1) the patient unit (PU); and 2) the patient management unit (PMU), which communicate with each other for data exchange. The PMU can be accessed by the PU through the internet using devices, such as PCs/laptops with direct internet access or mobile phones via a Wi-Fi/General Packet Radio Service access network. The PU consists of an insulin pump for subcutaneous insulin infusion to the patient and a continuous glucose measurement system. The aforementioned devices running a user-friendly application gather patient's related information and transmit it to the PMU. The PMU consists of a diabetes data management system (DDMS), a decision support system (DSS) that provides risk assessment for long-term diabetes complications, and an insulin infusion advisory system (IIAS), which reside on a Web server. The DDMS can be accessed from both medical personnel and patients, with appropriate security access rights and front-end interfaces. The DDMS, apart from being used for data storage/retrieval, provides also advanced tools for the intelligent processing of the patient's data, supporting the physician in decision making, regarding the patient's treatment. The IIAS is used to close the loop between the insulin pump and the continuous glucose monitoring system, by providing the pump with the appropriate insulin infusion rate in order to keep the patient's glucose levels within predefined limits. The pilot version of the SMARTDIAB has already been implemented, while the platform's evaluation in clinical environment is being in progress.

Experiences in Monitoring and Assessment of Sustainable Land Management

Although sustainable land management (SLM) is widely promoted to prevent and mitigate land degradation and desertification, its monitoring and assessment (M&A) has received much less attention. This paper compiles methodological approaches which to date have been little reported in the literature. It draws lessons from these experiences and identifies common elements and future pathways as a basis for a global approach. The paper starts with local level methods where the World Overview of Conservation Approaches and Technologies (WOCAT) framework catalogues SLM case studies. This tool has been included in the local level assessment of Land Degradation Assessment in Drylands (LADA) and in the EU-DESIRE project. Complementary site-based approaches can enhance an ecological process-based understanding of SLM variation. At national and sub-national levels, a joint WOCAT/LADA/DESIRE spatial assessment based on land use systems identifies the status and trends of degradation and SLM, including causes, drivers and impacts on ecosystem services. Expert consultation is combined with scientific evidence and enhanced where necessary with secondary data and indicator databases. At the global level, the Global Environment Facility (GEF) knowledge from the land (KM:Land) initiative uses indicators to demonstrate impacts of SLM investments. Key lessons learnt include the need for a multi-scale approach, making use of common indicators and a variety of information sources, including scientific data and local knowledge through participatory methods. Methodological consistencies allow cross-scale analyses, and findings are analysed and documented for use by decision-makers at various levels. Effective M&A of SLM [e.g. for United Nations Convention to Combat Desertification (UNCCD)] requires a comprehensive methodological framework agreed by the major players.

Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. LAY ABSTRACT: Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here explains how a biopharmaceutical process FMEA can be conducted. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. With the help of this guideline, different details of the manufacturing process can be ranked according to their potential risks, and this can help pharmaceutical companies to identify aspects with high potential risks and to react accordingly to improve the safety of medicines.

INTEGRATION D’UN OBSERVATOIRE URBAIN SUR GOOGLE MAPS : Cas des infrastructures de la santé de la ville de Douala Cameroun

The spectacular advances computer science applied to geographic information systems (GIS) in recent times has favored the emergence of several technological solutions. These developments have given rise to enormous opportunities for digital management of the territory. Among the technological solutions, the most famous Google Maps offers free online mapping dynamic exhaustive of the Maps. In addition to meet the enormous needs of urban indicators geotagged information, we did work on this project “Integration of an urban observatory on Google Maps.” The problem of geolocation in the urban observatory is particularly relevant in the sense that there is currently no data (descriptive and geographical) reliable on the urban sector; we must stick to extrapolate from data old and obsolete. This helps to curb the effectiveness of urban management to make difficult investment programming and to prevent the acquisition of knowledge to make cities engines of growth. The use of a geolocation tool coupled to the data would allow better monitoring of indicators Our project's objective is to develop an interactive map server (WebMapping) which map layer is formed from the resources of the Google Maps servers and match information from the field to produce maps of urban equipment and infrastructure of a city data to the client's request To achieve this goal, we will participate in a study of a GPS location of strategic sites in our core sector (health facilities), on the other hand, using information from the field, we will build a postgresql database that will link the information from the field to map from Google Maps via KML scripts and PHP appropriate. We will limit ourselves in our work to the city of Douala Cameroon with the sectors of health facilities with the possibility of extension to other areas and other cities. Keywords: Geographic Information System (GIS), Thematic Mapping, Web Mapping, data mining, Google API.

Virtopsy - the concept of a centralized database in forensic medicine for analysis and comparison of radiological and autopsy data

Recent developments in clinical radiology have resulted in additional developments in the field of forensic radiology. After implementation of cross-sectional radiology and optical surface documentation in forensic medicine, difficulties in the validation and analysis of the acquired data was experienced. To address this problem and for the comparison of autopsy and radiological data a centralized database with internet technology for forensic cases was created. The main goals of the database are (1) creation of a digital and standardized documentation tool for forensic-radiological and pathological findings; (2) establishing a basis for validation of forensic cross-sectional radiology as a non-invasive examination method in forensic medicine that means comparing and evaluating the radiological and autopsy data and analyzing the accuracy of such data; and (3) providing a conduit for continuing research and education in forensic medicine. Considering the infrequent availability of CT or MRI for forensic institutions and the heterogeneous nature of case material in forensic medicine an evaluation of benefits and limitations of cross-sectional imaging concerning certain forensic features by a single institution may be of limited value. A centralized database permitting international forensic and cross disciplinary collaborations may provide important support for forensic-radiological casework and research.

Respiratory syncytial virus infection in 406 hospitalized premature infants: results from a prospective German multicentre database

Premature birth, chronic lung disease of prematurity (CLD), congenital heart disease and immunodeficiency predispose to a higher morbidity and mortality in respiratory syncytial virus (RSV) infection. This study describes the preterms hospitalised with RSV infection from the prospective German DSM RSV Paed database. The DMS RSV Paed database was designed for the prospective multicentre documentation and analysis of clinically relevant aspects of the management of inpatients with RSV infection. This study covers six consecutive RSV seasons (1999-2005); the surveillance took place in 14 paediatric hospitals in Germany. Of the 1,568 prospectively documented RSV infections, 26% (n=406) were observed in preterms [vs. 1,162 children born at term (74%)] and 3% (n=50) had CLD, of which 49 had received treatment in the last 6 months ('CLDplus'). A significantly higher proportion in the preterm group had congenital heart disease, nosocomial infection, and neuromuscular impairment. There were significantly more children older than 24 months in the preterm group. The attributable mortality was 0.2% (n=2) in children born at term vs. 1.2% (n=5) in the preterm group (p=0.015) [preterm plus CLD 8.0% (n=4 of 50); McIntosh grade 1, 8.6% (n=3 of 35) and McIntosh Grade 4, 15% (n=3 of 20)]. Eight patients were categorized as 'palivizumab failures'. In the multivariate analysis, premature birth, CLD(plus), and nosocomial infection were significantly and independently associated with the combined outcome 'complicated course of disease'. In conclusion, this is the first prospective multicentre study from Germany that confirms the increased risk for severe RSV disease in preterms, in particular in those with CLD treated in the last 6 months before the onset of the infection. From the perspective of our results, the statements of the German Society of Paediatric Infectious Diseases considering the use of passive immunisation (2003) seem reasonable.

Information integration and management through the design and construction phases of a project life cycle

Information management is a key aspect of successful construction projects. Having inaccurate measurements and conflicting data can lead to costly mistakes, and vague quantities can ruin estimates and schedules. Building information modeling (BIM) augments a 3D model with a wide variety of information, which reduces many sources of error and can detect conflicts before they occur. Because new technology is often more complex, it can be difficult to effectively integrate it with existing business practices. In this paper, we will answer two questions: How can BIM add value to construction projects? and What lessons can be learned from other companies that use BIM or other similar technology? Previous research focused on the technology as if it were simply a tool, observing problems that occurred while integrating new technology into existing practices. Our research instead looks at the flow of information through a company and its network, seeing all the actors as part of an ecosystem. Building upon this idea, we proposed the metaphor of an information supply chain to illustrate how BIM can add value to a construction project. This paper then concludes with two case studies. The first case study illustrates a failure in the flow of information that could have prevented by using BIM. The second case study profiles a leading design firm that has used BIM products for many years and shows the real benefits of using this program.

Community managed rural water supply systems in the Dominican Republic : assessment of sustainability of systems built by the National Institute of Potable Water and Peace Corps, Dominican Republic

In the Dominican Republic economic growth in the past twenty years has not yielded sufficient improvement in access to drinking water services, especially in rural areas where 1.5 million people do not have access to an improved water source (WHO, 2006). Worldwide, strategic development planning in the rural water sector has focused on participatory processes and the use of demand filters to ensure that service levels match community commitment to post-project operation and maintenance. However studies have concluded that an alarmingly high percentage of drinking water systems (20-50%) do not provide service at the design levels and/or fail altogether (up to 90%): BNWP (2009), Annis (2006), and Reents (2003). World Bank, USAID, NGOs, and private consultants have invested significant resources in an effort to determine what components make up an “enabling environment” for sustainable community management of rural water systems (RWS). Research has identified an array of critical factors, internal and external to the community, which affect long term sustainability of water services. Different frameworks have been proposed in order to better understand the linkages between individual factors and sustainability of service. This research proposes a Sustainability Analysis Tool to evaluate the sustainability of RWS, adapted from previous relevant work in the field to reflect the realities in the Dominican Republic. It can be used as a diagnostic tool for government entities and development organizations to characterize the needs of specific communities and identify weaknesses in existing training regimes or support mechanisms. The framework utilizes eight indicators in three categories (Organization/Management, Financial Administration, and Technical Service). Nineteen independent variables are measured resulting in a score of sustainability likely (SL), possible (SP), or unlikely (SU) for each of the eight indicators. Thresholds are based upon benchmarks from the DR and around the world, primary data collected during the research, and the author’s 32 months of field experience. A final sustainability score is calculated using weighting factors for each indicator, derived from Lockwood (2003). The framework was tested using a statistically representative geographically stratified random sample of 61 water systems built in the DR by initiatives of the National Institute of Potable Water (INAPA) and Peace Corps. The results concluded that 23% of sample systems are likely to be sustainable in the long term, 59% are possibly sustainable, and for 18% it is unlikely that the community will be able to overcome any significant challenge. Communities that were scored as unlikely sustainable perform poorly in participation, financial durability, and governance while the highest scores were for system function and repair service. The Sustainability Analysis Tool results are verified by INAPA and PC reports, evaluations, and database information, as well as, field observations and primary data collected during the surveys. Future research will analyze the nature and magnitude of relationships between key factors and the sustainability score defined by the tool. Factors include: gender participation, legal status of water committees, plumber/operator remuneration, demand responsiveness, post construction support methodologies, and project design criteria.

Revenue Management in Make-To-Order Manufacturing: Case Study of Capacity Control at ThyssenKrupp VDM

While revenue management (RM) is traditionally considered a tool of service operations, RM shows considerable potential for application in manufacturing operations. The typical challenges in make-to-order manufacturing are fixed manufacturing capacities and a great variety in offered products, going along with pronounced fluctuations in demand and profitability. Since Harris and Pinder in the mid-90s, numerous papers have furthered the understanding of RM theory in this environment. Nevertheless, results to be expected from applying the developed methods to a practical industry setting have yet to be reported. To this end, this paper investigates a possible application of RM at ThyssenKrupp VDM, leading to considerable improvements in several areas.