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This paper describes a protocol for the technical and clinical evaluation of a workstation for the planning of stereotactic neurosurgical interventions that is being developed in the framework of a joint European research project (COVIRA). Although several such workstations have been proposed before, the final and most important step, that of clinical validation, often lacked. The developers failed to rigorously prove that their product was useful.
The method presented here basically assesses the clinical relevance of the user requirements that are at the root of the development of the new technology. The evaluation consists of two stages. During functional specification iterative prototyping is used to establish the clinical requirements and to assure the quality of the final product. A case study design is used in a second stage that assesses the clinical acceptability. A before-after study during a 6~month period gives a first indication of cost effectiveness and improvement of health care quality.
The workstation will be evaluated in an academic hospital. The neurosurgeons have actively participated in the development process.
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