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About PROMIS
Position on NIH Roadmap

About the NIH Roadmap

In May 2002, the Director of the National Institutes of Health (NIH) convened a series of meetings to chart a "roadmap" for medical research in the 21st century. The purpose of the NIH Roadmap is to identify major opportunities and gaps in biomedical research that no single Institute could tackle alone but that NIH as a whole must address to make the biggest impact on the progress of medical research. The ultimate goal of the Roadmap is to catalyze changes that are necessary for transforming new scientific knowledge into tangible benefits for people. Developed with input from meetings with more than 300 leaders in academia, industry, Government, and the public, the Roadmap provides a framework of priorities for optimizing the NIH research portfolio. It lays out a vision for a more efficient and productive system of medical research and identifies the most compelling opportunities in three areas: New Pathways to Discovery, Research Teams of the Future, and Re-engineering the Clinical Research Enterprise.

The theme of New Pathways of Discovery addresses the need to advance our understanding of complex biological systems and to build a better "toolbox" for medical research in the 21st century by providing wide access to technologies, databases, and other scientific resources that are more sensitive, robust, and easily adaptable to researchers' individual needs. The Research Teams of the Future seeks to encourage scientists to test alternative models for conducting research, including taking on unexplored avenues of research that carry a high potential for failure but also a greater chance for groundbreaking discoveries; stimulating new ways of combining skills and disciplines in the physical and biological sciences; and encouraging novel partnerships, such as those between the public and private sectors, to accelerate the movement of scientific discoveries from bench to bedside. Re-engineering the Clinical Research Enterprise is designed to accelerate and strengthen the clinical research process by adopting a systematic infrastructure to serve the field of scientific discovery better and more efficiently.

One of the programs within the Re-engineering the Clinical Research Enterprise initiative involves the Dynamic Assessment of Patient-Reported Chronic Disease Outcomes. In support of this initiative, in September 2004, the NIH initiated a multicenter cooperative group, referred to as the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS network of clinicians, clinical researchers, and measurement experts is organized around six primary research sites—Duke University, Stanford University, Stony Brook University, University of North Carolina at Chapel Hill, University of Pittsburgh, and University of Washington—and a Statistical Coordinating Center (CORE, Evanston Northwestern Healthcare and Northwestern University). PROMIS will contribute to that reengineering by building and validating common, accessible item banks to measure key symptoms and health concepts applicable to a range of chronic conditions, enabling efficient and interpretable clinical trial research and clinical practice application of patient-reported outcomes.

For more information about the NIH Roadmap, please visit the Web site at http://www.nihroadmap.nih.gov.

Overview of PROMIS Goals

 

The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative

established a collaborative relationship between NIH and individual research teams

through a cooperative agreement (U01) mechanism. The broad objectives of the

PROMIS Network were to:

       * Develop and test a large bank of items measuring patient-reported outcomes

       * Create a computerized adaptive testing system that allows for efficient, psychometrically

          robust assessment of patient-reported outcomes in clinical trial research involving a wide

          range of chronic diseases

       * Create a publicly available system that can be added to and modified periodically and that

          allows clinical researchers to access a common repository of items and computerized

          adaptive tests.

The network collaborated on the collection of self-reported data from diverse populations of individuals with a variety of chronic diseases, using agreed-upon methods, modes, and questionnaires.

Specific Research Objectives 

 

* Develop a core set of questions

- Primarily from existing items

- Most common dimensions of patient-reported outcomes

   relevant to the widest range of chronic diseases

- Large diverse sample

- Special interest in pain and fatigue

* Develop common metrics

* Create item banks using modern measurement theory

* Develop computer-adapted tests

* Create a Web-based, user-friendly repository

* Plan to maximize acceptance

* Conduct feasibility studies

* Plan for a public-private partnership

 

All PROMIS network members will participate in the planning and implementation of collaborative activities designed to address these research objectives. Within this framework, the grantees and NIH science officers will have primary responsibility for the project as a whole, including research design and protocol development.

                                     Where is PROMIS in the NIH Roadmap?

Primary Goals of PROMIS

* Build item pools and develop core questionnaires that measure key health outcome domains that are manifested in a variety of chronic diseases. The item pools will consist of existing items from established questionnaires and new items written by experts and tested in patient populations. All items considered for inclusion in the PROMIS item banks will undergo rigorous qualitative and cognitive review and quantitative review when possible.

* Establish and administer the PROMIS core questionnaire in paper and electronic forms to a large sample of individuals suffering from a variety of chronic diseases. Analyze and use collected data to calibrate the item sets to build the PROMIS item banks.

* Build an electronic Web-based resource for administering computerized adaptive tests, collecting self-report data, and reporting instant health assessments.

* Conduct feasibility studies to evaluate the utility of PROMIS and promote widespread use of the instrument for clinical research and clinical care.

* Support both independent and network-wide research projects that will benefit PROMIS.

* Develop a plan to establish a public-private partnership to sustain the repository, ensure scientific excellence, improve future data collection activities, add new domains and items to the system, test and adapt the system for new populations, maintain the system in the public domain, and extend the application of the system for clinical research and practice.

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