Recent developments in measurement technology can allow researchers and clinicians to assess patient reported outcomes (PROs) with greater validity, precision, and convenience. The goal of the Patient-Reported Outcomes Measurement Information System (PROMIS) network is to develop a unified approach for assessing PROs using computerized adaptive testing (CAT). The success of the network's efforts will depend in part on the ability to incorporate the technological achievements into multicenter clinical trials. To date, little work has addressed when and how these new assessment technologies should be incorporated into multicenter trials. These new methods bring potential for greater precision and less patient burden, but also for greater logistic complexity and cost.
The role of Duke University in the PROMIS network will be to identify and address challenges for using IRT-based assessments in multicenter clinical trials. We will accomplish these goals by pursuing five specific aims:
AIM 1: To develop options for integrating CAT into current and future data capture systems used in multicenter clinical trials. To address this aim, we will convene a task force involving experts in CAT, IRT, clinical trials operation management, data management/security, clinical trials network investigation, and regulatory affairs, as well as members of the PROMIS Steering Committee.
AIM 2: To assess the readiness of sites in multicenter clinical trials to collect PRO data using CAT. To address this aim, we will conduct a survey of 400 sites drawn from the 13 clinical trials networks located at Duke.
AIM 3: To conduct simulations to explore the costs and benefits of implementing different PRO data collection models in multicenter clinical trials. To address this aim, we will design a simulation that relates attributes of the measures (e.g., precision) and of the clinical trial (e.g., true effect size) to determine sample size, total cost, and satisfaction associated with different data collection models. This aim has particular relevance for Federal and commercial sponsors of clinical trials who must weigh the tradeoffs of different data collection models.
AIM 4: To develop recommendations for incorporating CAT into current and future data capture systems used in multicenter clinical trials. To address this aim, we will convene a broad expert panel that will include the PROMIS Steering Committee, trials operations experts, and Federal and commercial sponsors of clinical trials.
AIM 5: To anticipate how the PROMIS tool could be used in the context of daily electronic data collection methods. To address this aim, we will evaluate recent ePRO research describing greater precision of data, reductions in recall bias, and more rapid availability of data for analysis against current standards at Duke.
Thus, Duke's contribution to the PROMIS network will help inform industry when this advanced assessment framework will be beneficial and how best to incorporate it into multicenter trial operations. The proposed independent study directly addresses the specific objectives of the PROMIS network by maximizing acceptance of the PROMIS tool in the clinical research community and using feasibility study results to enhance the PROMIS network. We also propose two concepts for network-wide study relating to the assessment of pain and the definition of a standard process for determining minimally important differences in PROs.
For questions concerning Duke's role in the PROMIS network, please contact Kevin Weinfurt, PhD, by telephone at 919-668-8019 or by e-mail at kevin.weinfurt@duke.edu. For more information about the PROMIS network, go to http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-011.html or http://www.nihpromis.org.