Importance of Pilot Testing: Identifying Unique Challenges in DSM-5 Field Trials Design

• Activity Number: 109
• Type: Invited
• Date/Time: Monday, August 1, 2016 : 8:30 AM to 10:20 AM
• Sponsor: Mental Health Statistics Section
• Author(s): Diana E. Clarke* and Holly C. Wilcox and Bernadette A. M. Cullen
• Companies: American Psychiatric Association and Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine
• Keywords: Pilot testing ; Clinical Utility ; Mental Disorders ; DSM-5 Diagnoses ; Clinical samples

Abstract

The Fifth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) contains criteria changes for psychiatric diagnoses that reflect advances in the basic and clinical science and conceptualization of mental disorders. Also, it recommends research on dimensional measures of cross-cutting symptoms, disability and diagnostic severity, which are expected to better capture patients' experiences. Prior to DSM-5 release May 2013, the American Psychiatric Association (APA) conducted field trials to assess the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The field trials methods and measures were pilot tested in adult and pediatric clinical samples, in order to identify and correct any design and procedural problems prior to the expenditure of resources for the larger studies. Results from these pilot studies allowed for the refinement of the field trials protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the larger trials. These results highlight the benefits of pilot studies in planning large multisite studies.