More and more entities, including regulators (FDA and EMA), biopharma companies, clinicians, policymakers, payors, and researchers, recognize the value and importance of patient reported outcomes (PRO) as an essential ingredient in developing treatments and interventions that improve people’s lives. Assessments of the usefulness of a therapy and whether it should be reimbursed requires capturing the lived experience of individuals and families. It is critical that this be done in a rigorous and evidence-based manner.

Genetic Alliance is launching a burden of disease study by the people and for the people. We seek to give advocacy organizations and communities the data they need to assure all interested parties that the disease burden in their community can be measured and communicated.

We will be using the SF-36v2® questionnaire . It is a short-form health survey that measures each of the following eight health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each health domain score contributes to the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. This will be administered via Luna, the platform Genetic Alliance uses so that each person can decide how and with whom to share their data.

Each community can use the results of this study as they wish. In addition, we will analyze that data across conditions to offer it to policy makers across the globe as a testimony to the immense burden of disease.

Join us for a webinar on this study and the SF-36v2 instrument on Wednesday, March 29th, 12 PM ET (9 AM PT/6 PM CT). Our speaker will be Mark Kosinski, the Chief Commercial Science Officer at QualityMetric.

Mark Kosinski, MA

Mark has more than 30 years of experience in developing and analyzing patient-reported outcome (PRO) measures. He was involved with the development and validation of the SF-36®, SF-12® and the SF-8™ Health Surveys, the Asthma Control Test™ (ACT™), the Headache Impact Test™ (HIT-6™), and other industry-sponsored PRO measures, as well as the development and analysis of item banks for computerized adaptive health assessments. Mark has co-authored more than 300 peer-reviewed journal articles related to the development and analysis of PRO measures used in clinical research, randomized controlled trials, and population health initiatives. He has also contributed to the development of 10 manuals and interpretation guides for various PRO measures including the SF-36, SF-12, and SF-8. Over the past 25 years, he has been actively involved in working with the pharmaceutical industry in the analysis of clinical trial data with PRO measures as secondary indicators of treatment efficacy. Mark earned his bachelor’s degree in psychology from the University of Connecticut and his master’s in psychology from Bridgewater State University.