Journal of Medical Systems

, Volume 35, Issue 6, pp 1521–1530 | Cite as

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

  • Eric L. Eisenstein
  • Lawrence W. Diener
  • Meredith Nahm
  • Kevin P. Weinfurt
Original Paper

Abstract

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.

Keywords

Clinical trial Data collection Information systems Outcomes assessment 

Abbreviations

CAT

Computer adaptive test

DCRI

Duke Clinical Research Institute

EDC

Electronic data capture

FDA

US Food and Drug Administration

IRT

Item Response Theory

IVRS

Interactive Voice Response system

MRC

Medical Research Council

NIH

National Institutes of Health

PRO

Patient-reported outcome

PROMIS

Patient Reported Outcome Management Information System

T1

First translational roadblock

T2

Second translational roadblock

WBS

Work breakdown structure

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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Eric L. Eisenstein
    • 1
  • Lawrence W. Diener
    • 1
  • Meredith Nahm
    • 2
  • Kevin P. Weinfurt
    • 1
  1. 1.Duke Clinical Research InstituteDuke University Medical CenterDurhamUSA
  2. 2.Duke Translational Medicine InstituteDuke University Medical CenterDurhamUSA

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