HL7 Version 3 Domain Analysis Model: Major Depressive Disorder, Release 1

DESCRIPTION

These data elements were developed from data submitted to the U.S. Food and Drug Administration in marketing applications for drugs to treat Major Depressive Disorder (MDD). They are meant to support the collection of data during a patient encounter within a clinical research study. The data elements include concepts for DSM IV and 5 diagnoses and their specifiers as well as mental health specific patient characteristics, symptomatology, and history.

ALTERNATIVE NAMES

HL7 Version 3 Domain Analysis Model: Major Depressive Disorder, Release 1 may also go by the following names or acronyms:

TARGETS

• Quality Reporting Agencies
• Regulatory Agency
• Standards Development Organizations (SDOs)
• Pharmaceutical Vendors
• EHR, PHR Vendors
• Health Care IT Vendors
• Clinical Decision Support Systems Vendors
• Healthcare Institutions (hospitals, long term care, home care, mental health)

BENEFITS

• Enables standardization of data elements for the clinical data necessary for evaluating marketing applications for drugs to treat Major Depressive Disorder

IMPLEMENTATIONS/CASE STUDIES

• Clinical Data Interchange Consortium (CDISC) will use this standard as a foundation for their Study Data Tabulation Model (SDTM) Therapeutic Area User Guide (TAUG) to support the evaluation of marketing applications submitted to the U.S. Food and Drug Administration (FDA) for drugs to treat Major Depressive Disorder.

DEVELOPMENT BACKGROUND

The U.S. Food and Drug Administration (FDA) has a stated goal of standardizing disease-specific data elements in multiple therapeutic areas. Under this program and funded by grant number 1R24FD004271-01, data elements for Major Depressive Disorder (MDD) have been drafted.

The data elements were developed from a review of data collection forms from recent marketing applications submitted to the FDA for drugs to treat MDD as well as from forms for NIMH-funded studies.  MDD specific concepts were synthesized to form a set of distinct data elements, and definitions were drafted based on form context and existing standards, e.g., DSM-IV-TR, DSM 5. The data elements and their definitions were then carefully reviewed by a group of clinical thought leaders in MDD from academia and industry, and their feedback was incorporated. In addition, during balloting, feedback was sought from relevant clinical professional societies, with significant input received from the American Psychiatric Association (APA) and the International Society for CNS Clinical Trials and Methodology (ISCTM).

RELATED DOCUMENTS

HL7 Version 3 Domain Analysis Model: Major Depressive Disorder, Release 1

(Download)

TOPICS

• Care Provision
• Decision Support
• Patient Care
• Public Health
• Regulated Studies

STATUS DATE

2014-10-12

RESPONSIBLE WORK GROUP

PRODUCT TYPE

• Domain Analysis Model

STAKEHOLDERS

• Clinical Decision Support Systems Vendors
• EHR, PHR Vendors
• Health Care IT Vendors
• Healthcare Institutions
• Pharmaceutical Vendors
• Quality Reporting Agencies
• Regulatory Agency
• Standards Development Organizations (SDOs)

FAMILY

• V3

CURRENT STATE

• Stable

REALM

• Universal