Published May 17, 2013

State College, PA, USA – Increasingly, information about the benefits of a treatment is being obtained directly from patients, clinicians, and patients’ observers using clinical outcomes assessments (COAs). Clinical outcomes assessments are used to inform individual medical decisions as well as the drug approval process.  As a result of the growing importance of COAs, their number and diversity have increased exponentially to meet the needs of assessing concepts of health and well-being across a range of therapeutic areas. At the most basic level, COAs include core concepts that are considered to be fundamental elements of broader concepts. Dr. Pennifer Erickson (OLGA) and Dr. Richard Willke (Pfizer) evaluated the syntax and language of these core concepts for their study, “Examining Item Content and Structure in Health Status and Health Outcomes Instruments: Toward the Development of a Grammar for Better Understanding of the Concepts Being Measured,” published in Value in Health.  In the paper, the authors describe how they developed a descriptive grammar that can guide users on how to identify core concepts, understand each concept’s role in evaluating and making a statement of treatment benefit, and demonstrate the variety of ways that a core concept can be evaluated. This systematic approach to evaluating and classifying conceptual concepts in COAs aims to link patients’ reports of treatment benefit directly to health decision making at the clinical practice and macro policy level. Dr. Erickson explains, "The same core health concept can be queried in various ways depending on key wording within an item; we call the rules governing the phrasing within each items its grammar.  A high level of validity and comparability of interpretation across items relies on both the use and understanding of their grammatical structure."

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