Practical applications of usability theory to electronic data collection for clinical trials

Jordana K. Schmier, David W. Kane, Michael T. Halpern

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

Pharmaceutical and device companies are more frequently considering and using electronic data collection (EDC) to collect patient-reported outcomes such as satisfaction and quality of life for clinical trials. The transition from paper-and-pencil data collection to EDC is not without risks. The unique context of clinical trials presents challenges that, if not addressed, can lead to expensive mistakes. The advantages inherent to EDC can easily be cancelled out without careful attention to the characteristics of the clinical setting. This paper provides an overview of EDC issues specific to clinical trials and health care settings. In particular, it evaluates usability issues associated with methods of EDC and suggests strategies to minimize potential problems. Lessons learned from usability testing in the unique setting of the clinical trial can be applied to other projects to decrease costs, enhance the quality of the data, and minimize time to analysis.

Original languageEnglish (US)
Pages (from-to)376-385
Number of pages10
JournalContemporary Clinical Trials
Volume26
Issue number3
DOIs
StatePublished - Jun 2005

Keywords

  • Computer interface
  • Computer user training
  • Data collection
  • Medical informatics
  • Outcome assessment (health care)
  • Questionnaires
  • User

ASJC Scopus subject areas

  • Pharmacology (medical)

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