International scientific consensus on medical plantar pressure measurement devices: technical requirements and performance

Abstract

Abstract.Background. Since 2006, the Italian National Institute of Health (ISS) has been conducting independent scientific activities to standardize the technical assessment of plantar pressure measurement devices (PMDs). Material and methods. On the basis of the ISS results, in 2010 the Pedobarographic Group of the International Foot and Ankle Biomechanics community (i-FAB-PG) promoted a consensus activity about the main technical requirements for the appropriate use of PMDs. The activity relied on a moodlebased on-line forum, documents exchange, discussions, reviews, meetings and a final survey. Results. The participation of clinical and technical researchers, users, and manufacturers, contributed to the delivery of the hereby reported recommendations which specifically regard Medical PMDs in the form of platforms. Conclusions. The i-FAB-PG community reached overall agreement on the recommendations, with a few minor objections which are reported and commented in the document. Relevance. The present document, the highest result achievable within a small scientific community, will hopefully represent the starting point of the wider process of establishing official international guidelines or standards, within scientific communities and standardization organizations.Key words: baropodometry, pressure measurement devices, technical assessment, accuracy, cOP estimation.Riassunto (Consenso scientifico internazionale sui dispositivi medici per la misura delle pressioni plantari: requisiti tecnici e prestazioni). Background. A partire dal 2006, l'Istituto Superiore di Sanità (ISS) ha condotto attività scientifiche indipendenti mirate alla standardizzazione della valutazione tecnica di dispositivi per la misura della pressione plantare (PMDs). Materiali e metodi. A partire dai risultati dell'ISS, nel 2010 il Gruppo Pedobarografico della International Foot and Ankle Biomechanics community (i-FAB-PG) ha lanciato un'attività di consensus relativa ai requisiti tecnici essenziali per un uso appropriato dei PMD. L'attività si è basata su; un forum su piattaforma moodle; scambio, discussione e revisione di documenti; incontri finalizzati; verifica finale di agreement. Risultati. La partecipazione di ricercatori, utilizzatori clinici e tecnici, e produttori, ha contribuito alla definizione delle raccomandazioni qui di seguito riportate, che si riferiscono nello specifico a PMD utilizzati in ambito clinico, in forma di piattaforme. Conclusioni. La comunità i-FAB-PG ha raggiunto un accordo generale sul documento, con solo qualche residua minore obiezione, riportata e commentata nel documento. Rilevanza. È auspicabile che il documento, che costituisce il massimo risultato raggiungibile all'interno di una piccola comunità scientifica, possa rappresentare il punto di partenza di un più ampio processo per la definizione di linee guida ufficiali e di standard, nell'ambito di società scientifiche e di enti normatori.Parole chiave: baropodometria, dispositivi di misura di pressione, valutazione tecnica, accuratezza, stima centro di pre...

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