1. Defining in Detail and Establishing Consensus on DSM-5 Autism Spectrum Disorder (ASD) Criteria for Case Review CE Rice 1, LA Carpenter 2, AD Boan 2, MJ Morrier 1, C Skowyra 3, SL Bishop 4, N Hobson 5, A Thurm 6, W Zahorodny 7, C Lord 8 1 Emory University School of Medicine, Atlanta, GA; 2 Medical University of South Carolina, Charleston, SC; 3 Washington University in St. Louis, St. Louis, MO; 4 University of California San Francisco, San Francisco, CA; 5 Independent Consultant, TX; 6 National Institute of Mental Health, Bethesda, MD; 7 New Jersey Medical School, Westfield, NJ; 8 Weill Cornell Medical College, White Plains, NY Background Autism spectrum disorder (ASD) is diagnosed by professional evaluation of a person`s past and current behaviors in light of specified diagnostic criteria. Most research into ASD and Pervasive Developmental Disorder (PDD) diagnostic criteria has been on the agreement of overall diagnosis, the validity of subtypes, or on factor analysis of the primary domains and specific criteria representing those domains. Diagnostic criteria are updated periodically based on clinical and empirical findings. Within a given diagnostic taxonomy, little research has been done to specify the concepts and exemplars that serve as evidence for each individual criterion. Objective. To describe an iterative process used to define the spectrum of exemplars for each of the 7 core DSM-5 ASD criterion, and to evaluate interrater reliability of clinician reviewers applying these exemplars to determine ASD case status. Methods The methods followed a format developed for determining case status for U.S. population-based estimation of ASD prevalence (Yeargin-Allsopp et al., 2003; Rice et al., 2007; CDC, 2007, 2009, 2012, 2014, 2016). An initial criterion level mapping was utilized for a study comparing DSM-IV-TR and DSM-5 ASD prevalence estimates (Maenner et al., 2014). A team of clinicians completed an iterative process to identify specific exemplars for each of the 7 core DSM-5 behavioral diagnostic criterion and associated features. This included mapping exemplars to the DSM-5 ASD criteria from the following sources: DSM-IV-TR PDD criteria mapping (CDC’s ADDM Network); the DSM-5 text (APA, 2013); ADOS-2 and ADI-R scoring items. After each phase of mapping, consensus discussions were completed to clarify discrepancies. Use of the detailed criteria was piloted the South Carolina ADDM Network site as part of a supplemental study to compare DSM-IV-TR and DSM-5 record review and direct screening with clinical evaluation on a population-based cohort of children. Results For the initial reliability sample, composite records detailing developmental evaluations (n=79) of 10 children were independently reviewed by 2 clinician reviewers (CR, LC) to determine whether the individual behavioral exemplars could be reliably coded according to DSM-5 criterion mapping. For the initial sample, interrater reliability agreement averaged 93% agreement on the DSM-5 criteria (range 80-100%), 92% on early developmental concerns, 87% on associated features, 90% on earlier PDD diagnosis, 90% on final ASD case status, Severity levels were less consistent. Mapping was updated following discussion. For the full reliability sample, a 10% blinded reliability review sample from 240 children was completed on 173 evaluations for 23 children: 92% agreement on the DSM-5 criteria (ķappa =.73) See table 92% on early developmental concerns (ķ =.84) 86% on associated features (ķ =.69) 91% on earlier PDD diagnosis (ķ =.70) 91% on final ASD case status (ķ =.75) Final reviews and analyses of other ratings in progress. Summary and Conclusions Application of the DSM-5 ASD criteria is not well-specified in clinical practice, and both researchers and clinicians may be inconsistent in the specifics of how they arrive at a classification of ASD. Clinicians can reliably apply more detailed exemplars within criterion and across domains to characterize final ASD case status, associated features, and other overall diagnostic specifiers. This framework has been adapted for use in the CDC ADDM Network and is being evaluated for clinical use to improve consistency of ASD diagnoses. Acknowledgements: Other collaborators on this project include Monica Dirienzo and Lisa Wiggins of CDC, and Arline Fusco and Audrey Mars from NJ Medical School. The ADDM Network is supported through the Centers for Disease Control and Prevention (CDC) with funding for this specific study to SC-ADDM from Autism Speaks. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC, Autism Speaks, or affiliated institutions. For more information: Cathy Rice, cerice@emory.edu or Laura Carpenter, carpentl@musc.educerice@emory.educarpentl@musc.edu The process resulted in a case review manual detailing concepts and specific behavioral examples (over 300 exemplars) within each of the 7 Social and Behavioral criterion. A. Persistent deficits in social communication and interactions, as manifest by ALL of the following deficits in: 1. Social-emotional reciprocity; 2. Nonverbal communication behaviors used for social interaction; 3. Developing and maintaining relationships appropriate to developmental level (beyond caregivers) B. Restricted, repetitive patterns of behavior, interests, and activities, as manifested by at least TWO of the following: 1. Stereotyped or repetitive speech, motor movements, or use of objects 2. Excessive adherence to routines, ritualized patterns of verbal or nonverbal behavior, or excessive resistance to change 3. Highly restricted, fixated interests 4. Hyper- or hypo-reactivity to sensory input or unusual interest in sensory aspects of environment C. Symptoms must be present in early childhood (but may not become fully manifest until social demands exceed limited capacities) D. Symptoms cause clinically significant impairment in social, occupational, or other important areas of current functioning E. Disturbances are not better explained by intellectual disability or global developmental delay. Individuals with a well-established DSM-IV-TR diagnosis of autistic disorder, Asperger’s disorder, or PDD-NOS meet ASD diagnosis DSM-5 Criteria for ASD American Psychiatric Association (APA, 2013) Mapping Behavior Exemplars DSM-IV Autistic Disorder DSM-5 ASD Limited responsiveness to socially directed smiles1aA1 Impairment in initiating joint attention1cA1 Impairment in the pragmatics and/or semantics of language2bA1 Lack of directing eye contact, facial expressions, or gestures1aA2 Overfocus on parts of objects (e.g., buttons)3dB3 DSM-5% agreeKappa A196%.78 A287%.33 A391%.62 B196%.86 B287%.64 B387%.68 B3100%1.0 Social Initiations Social Responses A1 Social emotional reciprocity Awareness Interest Insight A3 Social relationships