PROTOCOL FOR THE CLINICAL FUNCTIONALITY ASSESSMENT OF A WORKSTATION FOR STEREOTAXIC NEUROSURGERY

The objective of this study is to establish a protocol for the technic al and clinical evaluation of a workstation for the planning of stereo tactic neurosurgical interventions that has been developed in the fram ework of a joint European research project, Although several such work stations have been proposed before, they lacked the final and most imp ortant step, that of clinical validation, They failed to rigorously pr ove that their product was useful, We present a new method that is app licable to the evaluation of a wide range of medical technologies, Our protocol basically assesses the clinical relevance of the user requir ements 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 i s used in a second stage that assesses the clinical usability, A befor e-after study gives a first indication of cost effectiveness and impro vement of health care quality.