DEVELOPMENT OF A CONCEPTUAL DISEASE MODEL TO INFORM STRATEGY TO EVALUATE TREATMENT IMPACT IN ADOLESCENTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Author(s)

Pokrzywinski R1;Setyawan J*2;Khan S3;Erder MH2;Hodgkins P2, Hareendran A4 1United BioSource Corporation, Murrysville, PA, USA, 2Shire Development LLC, Wayne, PA, USA, 3Neuroscience Inc., Herndon, VA, USA, 4United BioSource Corporation, London, United Kingdom

OBJECTIVES: To build a conceptual model describing disease experience in adolescent ADHD (aged 13–17) and impact of treatment, in order to inform the development of a measurement strategy to evaluate interventions. Conceptual models that summarize key concepts in describing disease experience are useful for developing strategies to measure meaningful treatment outcomes.  Adolescents are increasingly participating in making decisions about their healthcare. Hence, it is important to evaluate outcomes that are meaningful to them. METHODS: In preparation for patient interviews, focused searches of databases, clinical and regulatory guidelines, ADHD specific tools and conference abstracts were conducted as part of the literature review to identify concepts to understand the experiences of adolescents with ADHD from various perspectives.  In addition, concept elicitation interviews with 10 clinicians, 3 teachers, 10 peers and 10 siblings of adolescents with ADHD were conducted using semi-structured guides. Results from this preliminary stage were analyzed systematically; transcripts from the peer and sibling interviews were analyzed using a pre-defined coding dictionary, to identify concepts for the model. RESULTS: Disease-defining concepts in ADHD included core ADHD symptoms, problems with cognitive functions and problems with emotional dysregulation. ADHD was seen to impact everyday activities, social interactions and emotional functioning. These impacts had implications for the achievements at school; self-esteem and indulgence in risky behavior. Variables that moderate these impacts were also identified. The interrelationships among variables will be presented. The model was used to inform a strategy to evaluate outcomes of pharmacological treatments in adolescents with ADHD. The plausibility of the model was confirmed based on discussions with clinicians and drug development experts. CONCLUSIONS: An ADHD disease conceptual model was developed based on information from literature and stakeholders interviews, to describe ADHD in adolescents.  It will be used to develop a strategy for PRO development in adolescent ADHD and identify new outcomes.

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PMH53

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Mental Health

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