Résumé :
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Many techniques and methods exist to evaluate the functional capacity of patients suffering from neuromuscular disorders. Because each evaluator/physiotherapist (PT) has different skills and because each trial centre has different tools and practices, it is essential to standardize techniques and methods for the functional assessment of patients, particularly for multicentric studies, in order to improve the reproducibility and consistency of results. At the Institute of Myology, the Neuromuscular Physiology and Evaluation Lab, composed of 6 persons including 3 Physiotherapists, is developing a quality system based on the international standard ISO/CEI 17025 General requirements concerning the competence of the laboratories of calibrations and tests. The aim of this process is: - to guarantee the reproducibility and robustness of the results delivered - to reinforce our credibility with investigators, industrial partners and drug companies The first section concerns the management of the laboratory. Main requirements are: - to understand study objectives fully and adapt functional evaluations in consultation with investigators - to manage all the documents linked to a clinical trial according to formal procedures - to improve communication and follow-up with investigators by meetings, contracts and questionnaires - to detect all variations from correct procedures in order to improve the system The second section concerns measurement and metrology to ensure: - competence of the personnel by training and checking the reproducibility within- and between-PTs - proper control of equipment (functioning and calibration) - respect of evaluation procedures - metrological quality of equipment (compliance with national standards) - development and validation of new methods ISO 17025 is an industrial standard which needs some adaptations to be transferred to clinical settings. We plan to be accredited at the end of the year 2008 by the COFRAC (French Committee of accreditation). For scientific, ethical and financial reasons, it is fundamental to apply formal and rigorous methodology to ensure the quality of measurements. Quality assurance and metrology standards help towards reaching this goal.
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