Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study
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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.
KeywordsClinical trial Data collection Information systems Outcomes assessment
Computer adaptive test
Duke Clinical Research Institute
Electronic data capture
US Food and Drug Administration
Item Response Theory
Interactive Voice Response system
Medical Research Council
National Institutes of Health
Patient Reported Outcome Management Information System
First translational roadblock
Second translational roadblock
Work breakdown structure
The authors thank Allyn Meredith, MA for her expert work in editing this manuscript. We are also indebted to this study’s focus group participants from the DCRI and to other members of the PROMIS network for their efforts in developing the initial set of process diagrams. This study, including author funding and manuscript preparation, was supported by The National Institutes of Health’s Patient Reported Outcomes RFA: Dynamic Outcome Assessment (5U01 AR052186-04)—a Roadmap Initiative, Kevin Weinfurt Principal Investigator. The funding body did not participate in the study design, in the collection analysis, and interpretation of data, in the writing of the manuscript, or in the decision to submit the manuscript for publication.
The authors declare that they have no competing interests.
ELE and LWD participated in the conception and design of the study, analyzed and interpreted data, and drafted the manuscript. MN and KPW participated in the conception and design of the study, analyzed and interpreted data, and critically revised it for intellectual content. All authors read and approved the final manuscript.
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