Medical biomodelling in surgical applications: results of a multicentric European validation of 466 cases.

The study started in September 1999 and ended in April 2002. It is based on a questionnaire [www.phidias.org] assessing case-related questions due to the application of stereolithographic models. Each questionnaire contains over 50 items. These variables take into account diagnosis, indications and benefits of stereolithographic models with view on different steps of the surgical procedures: preoperative planning, intraoperative application and overall outcome after surgical intervervention. These questionnaires were completed by the surgeons who performed operation. Over the time course of our multicentric study (30 months), we evaluated 466 cases. The study population consists of n=231 male and n= 235 female patients. 54 surgeons from 9 European countries were involved. There are main groups of diagnosis that related to the use of a model. Most models were used in maxillofacial surgery. The operative planning may help to determine the resection line of tumor and optimize reconstructive procedures. Correction of large calvarian defects can be simulated and implants can be produced preoperatively. Overall in 58 % of all cases a time- saving effect was reported. The study strongly suggests, that medical modeling has utility in surgical specialities, especially in the craniofacial and maxillofacial area, however increasingly in the orthopedic field. Due to our results, medical modeling optimizes the preoperative surgical planning. Surgeons are enabeled to perform realistic and interactive simulations. The fabrication of implants, its design and fit on the model, allow to reduce operation time and in consequence risk and cost of operation. In addition, the understanging of volumetric data is improved, especially if medical models are combined with standart imaging modalities. Finally, surgeons are able to improve communication between their patientents and colleagues.

Anatomical accuracy in medical 3D modeling.

In complex surgery, medical modeling has become an accepted tool for diagnosis, simulation and the planning of surgical interventions [1]. However, the question concerning the accuracy of the model, i.e. the equivalence between the model itself on the one hand and the original anatomical situation on the other hand, remains unanswererd in the current literature.

[Does budgeting modify quality and efficiency of ambulatory drug therapy? Use of indicators exemplified by the prescribing behavior of established physicians of a North German region with predetermined quality deficits before introduction of the Health Structural Law]. / Beeinflusst eine Budgetierung Qualität und Wirtschaftlichkeit der ambulanten Arzneimitteltherapie? Anwendung von Indikatoren am Beispiel des Verorrdnungsverhaitens niedergelassener Arzte einer norddeutschen Region mit festgestellten Qualitätsdefiziten vor der Einführung des GSG.

Application of indicators exemplified by the prescribing conduct of physicians in a specific region of northern Germany showing deficits before implementation of the new GSG (Health Structure Law). The prescriptions of physicians in a specific region of northern Germany were examined to see whether the quality of drug therapy in this region, which showed deficits before the implementation of the GSG, had been influenced by this law. After encoding the prescription data the 100 most often prescribed drugs were identified as physician-related the resulting costs determined and arranged in order of precedence ("medicine charts"). The indicators were defined as to which "medicine-chart" drug they related, to facilitate a qualitative analysis of the prescriptions. The indicators were: Drugs, whose therapeutic advantage is not proven Drugs based on obsolete therapeutic concepts Drugs with lower-priced and/or therapeutic equal alternatives Standard-Therapeutics.

[Recycling of disposable medical devices (medical device products)]. / Wiederaufbereitung von Einmalartikeln (MD-Produkten).

Modern medicine uses large amounts of one-way-devices. This includes mass articles as well as technically sophisticated ones, all of them in accordance with GMP (Good-manufacturing-practice) guidelines. Recycling of selected one-way devices in technically possible and economically useful. Prerequisite for recycling is the inclusion of legal, economic and ecologic points of view. In addition the validation of processes and agreement on installation of continuous quality control is necessary to minimise risks. We suggest admission of recycling and reuse of one-way devices and suggest to proceed stepwise: 1. Principal decision to permit recycling 2. Appointment of an interdisciplinary Federal Board "Medical Devices" for coordination and channelling of activities 3. Selection of products for recycling 4. Principal decision for the systematics of the process together with: process control, product control during a pre-testing stage, random tests in prospective, multi-centre studies for the control of production and use. 5. Introduction of internal quality control systems to allow internal and external control of routine work.

[Implementation of the psychiatric personnel regulation--an intermediate-term evaluation]. / Die Umsetzung der Psychiatrie-Personalverordnung--eine Zwischenbilanz.

The new German Psychiatry Personnel Regulations were enforced in 1991. The aim was to set a standard for performance-adapted optimised personnel calculation for all professions taking part in stationary care and to initiate structural changes in psychiatric institutions. In general psychiatry, geronto-psychiatry, and addiction diseases, patients are classified in different categories according to the degree of disease and resulting therapeutic effort by the team taking part in therapy. In this manner personnel requirements are calculated prospectively in terms of working minutes. Realisation in Schleswig-Holstein is based on general agreements that allow evaluation, testing, and quality assurance by a graduated instrumentarium basing on valid data. A differentiated interventional management has been agreed upon. It will act in case of conflicts caused by the clinical classifications. Categorisation shows a clear trend towards classifying patients in the mandatory intensive care groups A2, S2 and G2. Correspondingly fewer patients are classified as requiring "standard treatment" and "treatment for severe and multiple sickness". This development is mainly supported by large specialised clinics and institutions with less than 50 beds. The acute-case departments of houses for central care show largely stable categorisation data during the 1 1/2 years of the survey. To evaluate the changes and trends a catalogue of structural points of view serves to verify the structural changes. Thus, criteria of quality are defined that contribute to an evaluation of the realisation of the new Personnel Regulations and support quality planning and management of the clinics.(ABSTRACT TRUNCATED AT 250 WORDS)

[Possibilities of quality assurance in ambulatory rehabilitation]. / Möglichkeiten einer Qualitätssicherung bei ambulanter Rehabilitation.

Formal, structurally determined quality requirements (for medical and non-medical staff, space and equipment, respectively) are supplemented by guidelines that are able to inform about the actual course of rehabilitation. Not only externally controlled medical reports on the treatment are suited for this, but also inquiries of patients comparisons between sickness insurances (for example on duration of inability to work, need for hospital measures of rehabilitation) and the comparison with patients who did not take part in ambulant rehabilitation. A report system has to be built up that pictures the clientele of the "reha"-institution, measures changes and documents results a long-term basis. The proposed periodical tests and final test serve not only for the control of patient progress in each single case with information for the practitioner, but also give financial committees hints on the efficiency of the work of the institutions for rehabilitation. Continuous attendance is proposed with a report system and scientific evaluation, whose results are sent concisely but anonymous by to the contract partners on a quarterly basis. A committee for quality assurance discusses new developments and improves ambulant rehabilitation.

[The tracer concept of quality assurance in the hospital--a critical evaluation]. / Das Tracer-Konzept der Qualitätssicherung im Krankenhaus--eine kritische Uberprüfung.

The "tracer concept", on which the introduction of quality assurance measures in Germany according to section 137 GRG is based, are critically confronted with the general test philosophy. It is shown that this tracer methodology does not come up to expectations and should be abandoned. Development and introduction of indicators are recommended that would be more appropriate to attain the target of quality assurance: quality improvement.