CDISC Public Webinar- Post Traumatic Stress Disorder Therapeutic Area User Guide 26 September 2017 Allyson Gage Cohen Veterans Biosciences Amy Palmer CDISC Kathleen Mellars CDISC Dana Booth - CDISC 1
AGENDA Project Background Introduction to PTSD PTSD TAUG Overview TAUG Organization Examples Technical Specification details Public Review Information Q&A 2
Background Development of the PTSD therapeutic area user guide (TAUG-PTSD) is being conducted under the umbrella of CFAST, a collaboration between CDISC and C-Path, with participation of NCI-EVS, FDA, and TransCelerate BioPharma, Inc CFAST: Coalition for Accelerating Standards and Therapies NCI-EVS: National Cancer Institute- Enterprise Vocabulary Service 3
Sources of Conceptual Input PhenX Toolkit for PTSD (https://www.phenxtoolkit.org/) Discussions with subject-matter experts Medical literature 4
Overview of TAUG Content Section 1, Introduction, provides an overall introduction to the purpose and goals of the Therapeutic Area Data Standards User Guide for PTSD. Section 2, Subject and Disease Characteristics, provides some general information on PTSD and representation of PTSD Diagnosis in SDTM and CDASH. Section 3, Disease Assessments, discusses relevant QRS for PTSD, skin conductance, startle response, and sleep study assessments in PTSD. Section 4, Routine Data, provides information collected on PTSD treatments. Section 5, Analysis Data, illustrates the use of the Analysis Data Model (ADaM) to create a dataset to support the analysis of skin conductance. 5
Introduction to Post-Traumatic Stress Disorder What is Post-traumatic Stress Disorder (PTSD)? A mental health problem that some people develop after experiencing or witnessing a life-threatening event Eg, combat, a natural disaster, a car accident, domestic violence, or sexual assault. PTSD is unusual Requires an interaction with the external environment Only a small percentage (8-20%) of people who have that interaction develop the disorder Symptoms can start right after the interaction or months later and the symptoms may come and go. Can only be diagnosed after one month. 6
Introduction to Post-Traumatic Stress Disorder PTSD is highly prevalent 80-90% of people will suffer a trauma in their lifetime 8% of the US population (8.6 million) suffers from PTSD during their lifetime 20% of OEF/OIF service members have PTSD (1 in every 5) 30% of Vietnam veterans suffered PTSD at some point after the war PTSD is a significant health burden Depression, anxiety disorders, and substance abuse, frequently co-occur PTSD affects not only those directly injured, but also caregivers and family members, as well as society as a whole US department of Veterans Affairs 7
Diagnosis No objective laboratory tests; clinical diagnosis DSM-V requires experienced/witnessed a traumatic event + symptoms across 4 criteria Re-experiencing the event (eg, flashbacks) Avoidance Negative thoughts/feelings Hyperarousal/reactivity (eg, heightened startle reflex, difficulty sleeping) + Symptoms last >1 month + Distress or functional impairment Clinician-Administered PTSD Scale (CAPS) interview Current version is CAPS-V, but many still use CAPS-IV or use CAPS-V with CAPS-IV scoring rules. 8
Treatment Options Currently available treatments Trauma-focused psychotherapy Cognitive Processing Therapy (CPT) Prolonged Exposure (PE) ~50% respond, not widely available, low completion rate Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline (Zoloft) Paroxetine (Paxil) ~40% respond 9
TAUG-PTSD Examples PTSD Diagnosis (CDASH and SDTM) PTSD Treatments (SDTM) Skin Conductance (SDTM and ADaM) Sleep Data (SDTM) Startle Data (SDTM) 10
CRF Layout Annotated CDASH CRFs CRF Metadata Indicates an expandable section to few metadata table
PTSD Symptoms and Medical History CDASH Example 12
Skin Conductance Patients with PTSD often exhibit stronger skin conductance when asked questions regarding a traumatic event or asked to imagine a traumatic event they have experienced. It is also known as galvanic skin response, electrodermal response, psychogalvanic reflex, skin conductance response, or skin conductance level, is a method of measuring the electrical conductance of the skin. used as an indication of psychological or physiological arousal normally measured with electrodes positioned on the index and middle fingers 13
Skin Conductance Concept Map 14
Skin Conductance SDTM Example The following slides provide an example on how to represent the Baseline and Trauma Challenge psychophysiological test which consists of a Baseline phase and a Trauma Challenge (includes Trauma Interview and Trauma Imagery) phase. The sponsor represented each of the Skin Conductance measurements during each phase of interest: Baseline, Trauma Interview, and Trauma Imagery. The measurements were obtained approximately five times per second. 15
Skin Conductance SDTM Example 16
Skin Conductance SDTM Example 17
Skin Conductance AdAM 18
QRS Instruments of Interest for TAUG-PTSD v1.0 Full Name and Abbreviation Deployment Risk and Resilience Inventory (DRRI-2) Copyright Permission Status Public domain Supplement Status In progress Life Events Checklist for DSM-5 (LEC-5) Public domain In progress PTSD Checklist for DSM-5 (PCL-5) Public domain In progress Impact of Event Scale Revised (IES- R) Modified PTSD Symptom Scale (MPSS- SR) Clinician-Administered PTSD Scale (CAPS) for DSM-5 with DSM-IV Clinician-Administered PTSD Scale for DSM-5 Child/Adolescent Version (CAPS-CA-5) Traumatic Events Screening Inventory for Children (TESI-C) Child Report Traumatic Events Screening Inventory for Children (TESI-C) Parent Report Requested Requested Granted Requested Public domain Public domain In progress In progress In progress Child PTSD Symptom Scale (CPSS) Public domain In progress Trauma Symptom Checklist for Children (TSCC) Granted In progress 19
QRS Instruments Continued Full Name and Abbreviation Trauma Symptom Checklist for Young Children (TSCYC) UCLA Child/Adolescent PTSD Reaction Index for DSM-5 Child Version UCLA Child/Adolescent PTSD Reaction Index for DSM-5 Parent Version Copyright Permission Status Granted Requested Requested Supplement Status In progress PSQI Pittsburgh Sleep Quality Index Blast Questionnaire Abbreviated Requested To be requested Combat Exposure Scale (CES) Public domain In progress Dot Probe Task Public domain In progress Emory Treatment Resistance Interview for PTSD (E-TRIP) RAND Social Support Survey Instrument Granted Public domain In progress In progress Instruments are published and maintained as standalone supplements; they do not appear in the TAUG itself All published instruments are available at https://www.cdisc.org/foundational/qrs 20
TA Specification- selected details 21
Domains No new domains were requested for this version of the TAUG The following Domains are used TAUG: Datasets CM MH NV PR RELREC RS DO DU DI DR Description Concomitant Medications Medical History Nervous System Findings Procedures Related Records Disease Response Device Properties Device In-Use Device Identifiers Device-Subject Relationships 22
Known Issues in TAUG-PTSD: --TESTCD/--TEST: precoordination vs. postcoordination Representation of derived data created from the output from a device: examples of derived data that was calculated by the external vendor represented in SDTM-based domains Representation of Device properties in DU: multiple testing sites are using the same device with different device set-up parameters, the set-up parameters must be provided for each subject. This may create a duplicate information when all subject at that test site are evaluated using the same set-up parameters. 23
Non-Standard Variables Parent Domain Variable Label CM TXAIND Treatment Augmentation Indicator CM WKCMP Weekly Compliance CM,PR TRLADQ Trial Adequacy CM,PR IMPLV Improvement Level CM,PR ETRIPS E-TRIP Score NV CUETYP Type of Cue PR TOTSES Total Number of Sessions 24
Public Review: 15 Sep 13 Nov CDISC and the TAUG-PTSD development team are seeking comment through Monday, November 13 th. 25
Public Review Information Review package available only on the CDISC WIKI Links/Instructions were provided in the Public Review announcement email https://wiki.cdisc.org/display/ptsdtaug/therapeutic+a rea+user+guide+for+post+traumatic+stress+disorder Reviewers are requested to make any comments directly via JIRA Detailed instructions are provided on the TAUG-PTSD WIKI page Wiki and JIRA use the same credentials, so if you can access the TAUG in the WIKI, then you can use JIRA. 26
Accessing and Reviewing the TAUG 27
Public Review Information cont. We recommend reading the TAUG-PTSD in its entirety at least once before jumping to specific sections or examples Keep the JIRA-PTSD page and the WIKI PTSD Therapeutic User guide open in separate windows Comments can be entered without navigating back and forth between the Wiki and JIRA. Always check to make sure the project selected in JIRA is PTSD. 28
Public Review Information cont. You can also make scope suggestions for future versions If you have no edits or comments on a page, click 'Like' at the bottom of the page. This will help us determine who has read each page. 29
Q&A 30
Any more questions? Thank you for attending this webinar. CDISC s vision is to: Inform Patient Care & Safety Through Higher Quality Medical Research 31