Marketplace Readiness of a Novel Transdiagnostic Assessment for Clinical Research and Practice

ABSTRACT In this SBIR Phase 1 proposal, we aim to develop and automate the workflow for a comprehensive transdiagnostic mental health assessment tool for increased precision in the screening of mental health. The majority of instruments presently in use have been designed based on DSM criteria, which has been critiqued for being theoretically defined and ignoring the heterogeneity of symptoms across patients. Furthermore, individual tools are incomplete and heterogeneous in their assessment of symptoms for the same disorder. Thus, individuals are placed into pre-defined categories that do not reflect their overall symptom experience and life factors, and diagnosis can vary based on the choice of tool. This makes it difficult and time consuming to understand individual patients to determine treatment trajectories, effectively recruit patients into research trials, and understand outcomes based on complete symptom phenotypes. In order to address these challenges, a novel assessment tool, the cMHQ, has been developed by our partner non-profit research organization, Sapien Labs, and provides a comprehensive patient symptom profile that maps across 10 DSM-based mental health disorders, as well as dimensional scores across six functional areas, thereby forming a bridge between the current diagnostic environment and the more research oriented RDoC framework. The proposed research focuses on transitioning the cMHQ and its outcomes from lab to marketplace to enable deeper clinical research insights and provide more informed treatment and referral regimens. In aim 1, we will build the cMHQ’s input assessment and diagnostic analysis by developing a responsive front-end assessment application and coding analysis scripts to generate data scoring metrics and diagnostic criteria. In aim 2, we will develop multiple data- output formats for the cMHQ that are tested for usability and acceptability, including an automatically generated cMHQ clinician report that provides a clear and comprehensive analysis of the patient’s mental health profile across multiple dimensions and disorders, as well as an API to enable tabular data outputs for integration into research systems. As part of this aim, we will also integrate all of the elements into a scalable architecture for testing and ensure HIPAA-compliance of the data-flow. If this project is successful, a further Phase 2 project will be warranted to pilot test its application in clinical research and practice domains to demonstrate the benefits to outcomes in both research and treatment.NARRATIVE Existing mental health screening tools provide an incomplete view of patient symptom profiles, are inconsistent within disorders, and force patients with heterogeneous symptom profiles into predefined labels that are misleading, thereby compromising effective choice of treatment and clinical research outcomes. The cMHQ is a screening instrument developed by Sapien Labs, our affiliate nonprofit research organization, and is designed to overcome these limitations by providing a comprehensive view of patient symptoms mapped to ten DSM- based disorders along with relevant life circumstance elements and scores across functional domains more relevant for research. Sapien Health will develop this tool for use in commercial settings of clinical research and practice, delivering multiple outputs in a HIPAA-compliant workflow that is expected to surpass existing tools in diagnostic validity and clinical utility within research and clinical domains.