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Functional equality of coordinating centers in a multicenter clinical trial. Experience of the International Mexiletine and Placebo Antiarrhythmic Coronary Trial (IMPACT).

The International Mexiletine and Placebo Antiarrhythmic Coronary Trial (IMPACT) included clinical centers in both Europe and North America. The clinics were monitored by two Regional Coordinating Centers: one located in Baltimore, Maryland, for North American clinics; the other in Lyon, France, for European clinics. These coordinating Centers were in turn monitored by an independent Data Audit Center located in Chicago, Illinois. This article describes how computer systems and operational procedures were developed to allow the three IMPACT centers to exchange processed files for a common analysis by the two Regional Coordinating Centers. The problems encountered and the advantages of this organization are described and discussed.

Arrhythmias, Cardiac↗

To die with dignity.

This paper examines the conundrum facing an individual with a terminal disease who wishes to end his or her life in a manner that maintains a minimum of dignity. The State's interest versus the individual's right to live or die is examined in its various aspects. The interference by the State supplanting the Church as the authority that interprets the boundaries between life and death, with the individual losing his voice as well as his body to the impersonality of maintaining a life not worth living, is studied, as well as the implicit dangers when the freedom to decide when and who should die is measured against the present international economic situation. The need to listen to the language of the dying as well as to their need for a 'closure' is approached with a view to future study.

Advance Directives↗

Differential expression of cytochrome c oxidase subunit III gene in castes of the termite Reticulitermes santonensis.

Social insects such as termites live in colonies in which cooperation is assumed by all individuals developing into castes to which specific tasks are allocated. Little has been reported about molecular aspects underlying termite caste-specific gene expression. Genetic regulation has recently been hypothesized to govern caste-specific traits and physiology in social insects. Cytochrome c oxidase (COX) has been shown to be an interesting candidate for expression study in insects. We used the cytochrome c oxidase subunit III gene (COXIII) that was cloned from mRNA in a lower termite, Reticulitermes santonensis De Feytaud (Isoptera; Rhinotermitidae). The full-length cDNA encodes a protein of 262 amino acids that shows high degree of homology with other insects COXIIIs. Reverse transcriptase-PCR and real-time PCR were performed to compare gene expression between larvae, workers, nymphs and soldiers. Analyses performed on head cDNAs revealed that COXIII is differentially expressed between castes. The level of COXIII is caste-regulated with an increase in workers (approximately 1.9-fold) and nymphs (approximately 2.8-fold) and a decrease in soldiers (0.8-fold) compared to the expression level in larvae (1.0-fold). These results may emphasize the physiological importance of COX in the termite brain at different developmental stages.

Amino Acid Sequence↗

Tissue banking programmes in Europe.

In Europe, organ centres such as Bio Implant Services (BIS) in cooperation with Eurotransplant, play an intermediary role from donation of tissue and organs to allocation and transplantation. They take responsibility for donor medical/safety screening and organize procurement. Tissue banks are autonomous and are responsible for tissue processing and preservation. Allocation of scarce tissues is performed according to rules set by committees of renowned experts in the field. Most frequently donated types of tissues are corneas, heart valves, bone and soft tissue and skin. In this article, optimal serological screening of the donor, and the banking of these tissues in Europe is reviewed in relation to clinical need and volume of transplantable tissues available, number of banks and their organisational level, methods of explantation, processing and preservation, quality standards and new developments.

Bone Banks↗

Ethical aspects of human germ-line gene therapy.

This presentation remains limited to a survey of the current debate on germ-line gene therapy. Most of the official, often national, reports show great restraint. On the other hand more and more ethicists have taken a positive stance in the matter. Both these viewpoints will be reflected in the overview.

Advisory Committees↗

The promise--and peril--of integrated cost systems.

Recent advances in managerial accounting have helped executives get the information they need to make good strategic decisions. But today's enterprise resource planning systems promise even greater benefits--the chance to integrate activity-based costing, operational-control, and financial reporting systems. But managers need to approach integration very thoughtfully, or they could end up with a system that drives decision making in the wrong direction. Operational-control and ABC systems have fundamentally different purposes. Their requirements for accuracy, timeliness, and aggregation are so different that no single, fully integrated approach can be adequate for both purposes. If an integrated system used real-time cost data instead of standard rates in its ABC subsystem, for example, the result would be dangerously distorted messages about individual product profitability--and that's precisely the problem ABC systems were originally designed to address. Proper linkage and feedback between the two systems is possible, however. Through activity-based budgeting, the ABC system is linked directly to operations control: managers can determine the supply and practical capacity of resources in forthcoming periods. Linking operational control to ABC is also possible. The activity-based portion of an operational control system collects information that, while it mustn't be fed directly into the activity-based strategic cost system, can be extremely useful once it's been properly analyzed. Finally, ABC and operational control can be linked to financial reporting to generate cost of goods sold and inventory valuations--but again, with precautions.

Budgets↗

Achilles' helix.

Explore the source record for details and available documents.

Attitude↗

From financial analysis to policy development in mental health care: the need for broader conceptual models and partnerships.

International mental health economics is emerging as a significant field in the increasingly intricate and interactive world in which we live. In line with this, the conceptualisation and gathering of pertinent data for international studies such as WHO's Atlas Project pose considerable methodological challenges. This paper outlines the need for broader conceptual models and partnerships and discusses some promising endeavours.

Global Health↗

[Isomeride and treatment of overweight].

Controlled European studies of 1 315 patients in medium (3 month) and long term (6 month, 1 year) trials have shown the efficacy and safety of Isomeride in the treatment of overweight. Three month studies of Isomeride plus diet versus placebo plus diet have shown an average weight loss of 3 kilograms in the first month and 7 kilograms after 3 months treatment in the Isomeride group. The difference with placebo was significant in the first month and increased in the following months. Drop out was similar in both groups. The safety of Isomeride made possible long term treatment of particularly severe refractory cases of overweight. A 6 month English trial confirmed these results and a research programme is underway to assess the value of 1 year and more therapy with Isomeride.

Double-Blind Method↗

[Phase III study of carboplatin in ovarian cancer].

A phase III study of carboplatin vs cisplatin in CAP regimen for ovarian cancer was conducted by a cooperative study group consisting of 22 institutions nationwide. The response rate for 23 cases allocated to carboplatin regimen group was 34.8% and 42.1% for 19 cases allocated to cisplatin regimen group. No significant difference was observed between these two regimens in response rates, and no significant differences were noted between the two regimens in each of the clinical toxicities and abnormalities in laboratory findings. Since the carboplatin regimen group did not require hydration, or the use diuretics or antiemetics, these results suggested that carboplatin is more useful in the treatment of ovarian cancer than cisplatin.

Adult↗