Electronic data capture for registries and clinical trials in orthopaedic surgery: open source versus commercial systems.

Published

Journal Article (Review)

BACKGROUND: Collection and analysis of clinical data can help orthopaedic surgeons to practice evidence based medicine. Spreadsheets and offline relational databases are prevalent, but not flexible, secure, workflow friendly and do not support the generation of standardized and interoperable data. Additionally these data collection applications usually do not follow a structured and planned approach which may result in failure to achieve the intended goal. QUESTIONS/PURPOSES: Our purposes are (1) to provide a brief overview of EDC systems, their types, and related pros and cons as well as to describe commonly used EDC platforms and their features; and (2) describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system. WHERE ARE WE NOW?: Electronic data capture systems aimed at addressing these issues are widely being adopted at an institutional/national/international level but are lacking at an individual level. A wide array of features, relative pros and cons and different business models cause confusion and indecision among orthopaedic surgeons interested in implementing EDC systems. WHERE DO WE NEED TO GO?: To answer clinical questions and actively participate in clinical studies, orthopaedic surgeons should collect data in parallel to their clinical activities. Adopting a simple, user-friendly, and robust EDC system can facilitate the data collection process. HOW DO WE GET THERE?: Conducting a balanced evaluation of available options and comparing them with intended goals and requirements can help orthopaedic surgeons to make an informed choice.

Full Text

Cited Authors

  • Shah, J; Rajgor, D; Pradhan, S; McCready, M; Zaveri, A; Pietrobon, R

Published Date

  • October 2010

Published In

Volume / Issue

  • 468 / 10

Start / End Page

  • 2664 - 2671

PubMed ID

  • 20635174

Pubmed Central ID

  • 20635174

Electronic International Standard Serial Number (EISSN)

  • 1528-1132

International Standard Serial Number (ISSN)

  • 0009-921X

Digital Object Identifier (DOI)

  • 10.1007/s11999-010-1469-3

Language

  • eng