S29: Advancing Outcomes Measurement and Data Collection in Integrative Medicine Clinical Research Using NIH PROMIS and Assessment Center Applications

David Victorson1, Melinda Ring2

1Northwestern University's Feinberg School of Medicine, USA; 2Northwestern Integrative Medicine, USA

 

Interest in assessing self-reported outcomes in integrative medicine research and clinical practice has increased dramatically over the last 20 years. Health-related Quality of Life (HRQL) is now an accepted outcome of interest in both federally- and industry-funded clinical research studies, and patient-reported outcomes (PROs) are increasingly used by health care providers and patients to make decisions regarding treatment options. With this explosion of interest have come new challenges to measuring, analyzing and interpreting PROs, and to translating HRQL and other PRO data from research to clinical arenas. The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative designed to develop, validate and standardize PRO tools for clinical research and practice. The goals of PROMIS include developing and testing item banks in five broad domains (fatigue, pain, physical function, emotional distress and social health) as well as domains with special relevance to individual diseases and conditions. These item banks enable computerized adaptive testing (CAT) to derive valid, efficient and tailored PRO assessments that are more precise than those developed using classical approaches, and less burdensome to both patients and staff. This workshop will introduce researchers and clinicians to the PROMIS project and tools. We will provide an overview of the PROMIS initiative and its focus on developing instruments appropriate across a range of integrative medicine therapies and medical conditions and points in the care continuum. Qualitative and quantitative methodologies for instrument development will be described. Next we will provide an overview of Assessment Center, a free, online research management tool that enables tracking item development, administration of PRO instruments including CATs, manages accrual and exports data. Assessment Center allows researchers and clinicians to create study-specific websites to administer PROMIS and other PRO measures to patients. It includes features allowing for complex longitudinal study designs, customized instruments, randomization, and online consenting. Finally, we will put PROMIS and Assessment Center into context by describing our experience using these tools to prospectively and longitudinally monitor clinical acupuncture outcomes among a group of acupuncture practitioners. In conclusion, PROMIS represents an exciting new approach to measuring PROs in integrative medicine clinical research that is more precise and patient-centered, but less burdensome, than currently-used measures.