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FACIT.org History OVER 25 YEARS OF IMPROVING PATIENT HEALTH STATUS MEASUREMENT 1990’s 1997 Late 90’s Mid-2000’s 2018 TODAY 1980’s FACIT.org is the licensing entity for the well-known FACIT measurement system. Because of its strong development and validation processes plus its exceptional measurement characteristics, the FACIT System is widely used in clinical and academic research, as well as in clinical trials to capture the patient's perspective of their disease, treatment or condition. 1980s 1980’s The patient's perspective in focus Renowned health outcomes researcher David Cella, Ph.D., develops the Functional Assessment of Cancer Therapy (FACT) questionnaire while completing his post-doctoral studies at Memorial Sloan Cancer Center in New York. (Cella et al, 1993) The results of his work formed the cornerstone of the Functional Assessment of Chronic Illness Therapy, a compilation of over 100 distinct self-report questionnaires that assess a wide variety of symptoms, functional abilities, general perceptions of health and well-being, and other aspects of health-related quality of life. Some of these questionnaires are disease-specific (e.g., cancer, multiple sclerosis, HIV disease), some are related to specific treatment-related toxicities (e.g., central or peripheral neurotoxicity, gastrointestinal toxicity), some are symptom focused (e.g., pain, fatigue), others address physical, mental and social function, and still others assess mood and well-being. All were developed and created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages in which each item has been translated. ​ Cella D.F., Tulsky D.S., Gray G., Sarafian B., Lloyd S., Linn E., Bonomi A., Silberman M., Yellen S.B., Winicour P., Brannon J., Eckberg K., Purl S., Blendowski C., Goodman M., Barnicle M., Stewart I., McHale M., Bonomi P., Kaplan E., Taylor S., Thomas C., Harris J. The Functional Assessment of Cancer Therapy (FACT) Scale: Development and validation of the general measure. Journal of Clinical Oncology 1993; 11(3): 570-579. 1990 1997 Late 90s Mid-2000s 2018 Today 1990’s The FACT goes global As globalization evolves, the demand for valid, translated versions of the FACT measures rises. The FACT Translation Project begins, and the FACT-G (General), FACT-B (Breast), FACT-Br (Brain), FACT-BMT (Bone Marrow Transplant), FACT-C (Colorectal), FACT-CNS (Central Nervous System), FACT-Cx (Cervical), FACT-E (Esophageal), FACT-H&N (Head & Neck), FACT-L (Lung), FACT-P (Prostate), FACT-O (Ovarian), and FAHI (HIV) become the first measures translated and linguistically validated into 7 languages following a newly-developed FACIT translation methodology ensuring equivalence across translations. Today, over 100 measures are available in over 80 languages. 1997 FACT becomes FACIT Functional Assessment of Chronic Illness Therapy (FACIT) is adopted as the formal name to reflect the FACT’s growth and evolution into a system that also includes content to measure diseases, treatments and conditions outside oncology. Late 90’s Item Response Theory and FACIT Advanced methods in statistical and psychometric approaches including item response theory (IRT) provide increasingly robust analytic methods permitting analysis on a per-item basis. Use of IRT to examine an item’s measurement characteristics gives investigators a way to lower patient response burden by only administering items most relevant to patients. Mid-2000’s Dr. Cella launches PROMIS The National Institute of Health supports this science via an initiative known as PROMIS (Patient Reported Outcomes Measurement Information System), in which Dr. Cella is the Principal Investigator of the Statistical Coordinating Center. A second federally-funded item-banking project specific to neurological conditions, Neuro-QOL, follows; Dr. Cella grants permission for FACIT items to be used in both these initiatives so that these FACIT items can be scored on a national metric. Dr. Cella remains a central resource to the PROMIS Health Organization to this day. 2018 ​ FACIT Searchable Item Library In 2018, the FACIT Searchable Item Library is released. Users may now search FACIT’s 700+ items and develop a custom measure targeted to their specific patients using the Build-a-PRO function. Today Looking ahead FACIT continues to evolve with increasing focus on individual item measurement, the use of Clinical Outcomes Assessments (COA’s) in routine clinical practice and new items and measures for use with immune checkpoint modulator (ICM) treatments for chronic illness. Meet the Team David Cella, PhD President, Chief Scientific Officer Jason Bredle, MFA Director Shannon Romo Licensing and Financial Administrator MEET THE WHOLE TEAM

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