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Electronic Case-Report Forms of Symptoms and Impairments of Peripheral Neuropathy

  • Peter J. Dyck (a1), David W. Turner (a2), Jenny L. Davies (a1), Peter C. O’Brien (a3), P. James B. Dyck (a1), Cynthia A. Rask (a4) and the rhNGF group...

Abstract

Background and objective:

For the conduct of controlled clinical trials, epidemiologic surveys or even of medical practice of varieties of peripheral neuropathy, the usefulness, error rate and cost-effectiveness of scannable case-report forms has not been studied. Materials and

Methods:

The overall performance, the frequency of the problems identified and corrected, and the time saved from use of a standard paper case report form was evaluated in multicenter treatment trials, single center epidemiologic surveys and in our neurologic practice. The paper case report form (Clinical Neuropathy Assessment [CNA]) for pen entry at study medical centers for patient, disease and demographic information (Lower Limb Function [LLF] and Neuropathy Impairment Score [NIS]) can be faxed to a core Reading and Quality Assurance Center where the form and data is electronically and interactively evaluated and corrected, if needed, by participating medical centers before electronic entry into database.

Observations and conclusions:

1) The approach provides a standard, scannable paper case report form for pen entry of neuropathy symptoms, impairments and disability at the bedside or in the office which is retained as a source document at the participating medical center but a facsimile can be transferred instantaneously, its data can be programmed, interactively evaluated, modified and stored while maintaining an audit trail; 2) it allowed efficient and accurate reading, transfer, analysis, and storage of data of more than 15,000 forms used in multicenter trials; 3) in 500 consecutive CNA evaluations, software programs identified and facilitated interactive corrections of omissions, discrepancies, and disease and study inconsistencies, introducing only a few readily identified and corrected entry errors; and 4) use of programmed, as compared to non-programmed assessment, was more accurate than double keyboard entry of data and was approximately five times faster.

RÉSUMÉ: Introduction et Objectif:

Pour la conduite d’essais thérapeutiques, d’enquêtes épidémiologiques ou même en pratique médicale portant sur différentes neuropathies périphériques, l’utilité, le taux d’erreur et le coût/bénéfice des formulaires d’exposé de cas (FEC) n’ont pas été étudiés.

Matériels et Méthodes:

La performance globale, la fréquence de problèmes identifiés et corrigés, et le temps épargné par l’utilisation de FEC papier standards ont été évalués dans des essais multicentres, des enquêtes épidémiologiques réalisées dans un centre et dans notre pratique neurologique. Le FEC papier (Évaluation Clinique de la neuropathie [ÉCN]) rempli à la main au site de l’étude et contenant l’information sur le patient, la maladie et les données démographiques (Lower Limb Function – LLF et Neuropathy Impairment Score – NIS) peut être transmis par télécopieur à un centre de lecture et de contrôle de qualité où le formulaire et les données sont évalués et corrigés électroniquement et interactivement au besoin par les centres médicaux participants avant la saisie électronique dans une base de données.

Observations et Conclusions:

1) Cette approche fournit un FEC papier standard, complété à la main au lit du malade ou au bureau, pour saisie électronique sur les symptômes de neuropathie, les déficits et l’invalidité qui est conservé comme document source au site participant. Un fac-similé peut être transféré instantanément, ses données peuvent être programmées et évaluées interactivement, modifiées et conservées tout en maintenant un document source pour vérification; 2) elle permet la lecture, le transfert, l’analyse et la conservation efficace et précise de données de plus de 15 000 formulaires utilisés dans des essais multicentres; 3) dans 500 ÉCNs consécutives, des programmes informatiques ont identifié et facilité la correction interactive d’omissions, de divergences et de contradictions quant à la maladie et à l’étude, introduisant seulement un petit nombre d’erreurs d’entrée de données facilement identifiées et corrigées; et 4) l’utilisation d’une évaluation programmée comparée à une évaluation non programmée était plus exacte qu’une double entrée de données au clavier et était approximativement cinq fois plus rapide.

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