title: Practical applications of usability theory to electronic data collection for clinical trials.
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.
authors.affiliation: Exponent, 1800 Diagonal Road, Suite 300, Alexandria, VA 22314, United States. jschmier@exponent.com
authors.forename: Jordana K
authors.initials: JK
authors.lastname: Schmier
authors.forename: David W
authors.initials: DW
authors.lastname: Kane
authors.forename: Michael T
authors.initials: MT
authors.lastname: Halpern
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003197:Computer Literacy; D003362:Cost-Benefit Analysis; D003625:Data Collection / Q000379:methods; D003628:Database Management Systems; D001330:Electronic Data Processing; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D012108:Research Personnel / Q000193:education; D011795:Surveys and Questionnaires; D018511:Systems Integration; D014584:User-Computer Interface