Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

Journal Article

New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

Full Text

Duke Authors

Cited Authors

  • Eisenstein, EL; Diener, LW; Nahm, M; Weinfurt, KP

Published Date

  • December 2011

Published In

Volume / Issue

  • 35 / 6

Start / End Page

  • 1521 - 1530

PubMed ID

  • 20703765

International Standard Serial Number (ISSN)

  • 0148-5598

Digital Object Identifier (DOI)

  • 10.1007/s10916-010-9429-8

Language

  • eng

Conference Location

  • United States