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The U.S. Food and Drug Administration (FDA) has awarded a grant to Northwestern University to develop standard core sets of clinical outcome assessments that focus on physical function as they apply to a range of common and rare disorders. Northwestern University Clinical Outcome Assessment Team (NUCOAT) to develop and validate these standard core sets of clinical outcome assessments in collaboration with the National Organization for Rare Disorders (NORD), Alliance in Aging Research (AAR) and University of Maryland. These core outcome sets will leverage an extensive array of validated, publicly available HealthMeasures assessments, including content from PROMIS, NIH Toolbox, and Neuro-QoL measurement systems.

NUCOAT’s goal is to capture the broad range of physical function impacts that individuals with both common (e.g., sarcopenia) and rare conditions experience.

  • Physical function is defined as “the functioning of one’s upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living” (healthmeasures.net).
  • Physical function is a significant and highly-relevant common impact for many diseases, disorders, and treatments. Most chronic diseases, and their treatments, produce unwanted physical and mental symptoms. In turn, these symptoms often limit the ability of people to live fully functional lives.
  • Sarcopenia is the decline in skeletal muscle mass accompanied with decreased strength and/or function. This commonly occurs as a result of age, reduced muscle activity or certain comorbid conditions (for more info, click here). This can negatively impact physical function in a variety of ways.
  • Rare disorders are those that affect less than 1% of the population. Some rare disorders can have large impacts on physical function due to the disorder and/or treatment.

For more information on how we are preparing, see the Planning Phase. For more information on how we will proceed with data collection, see the Research Phase.

Team Members