Intelligent Suicide Risk Assessment in Clinical Research

AVERT™ is ERT’s electronic suicide risk assessment system that provides simple audio (phone) or visual (web or tablet) solutions that are efficiently and effectively implemented in any clinical study.   When utilizing AVERT, patients or clinicians complete the suicide risk assessment directly in an electronic format. By doing so, investigative sites can count on systematic, comprehensive, and consistent assessments that reduce both patient and site staff burden when compared to traditional paper methods. AVERT electronically deploys scientifically proven suicide risk assessments, which includes the application the Columbia-Suicide Severity Rating Scale (C-SSRS) and the patient self-reported version of the Columbia (eC-SSRS), which are cited in the draft FDA SIB guidance as acceptable methods for assessing suicide risk.  

The Patient-Reported eC-SSRS

By working closely with Dr. Kelly Posner, the lead author of the C-SSRS, ERT developed an electronic fully-structured, patient-reported version of the C-SSRS called the eC-SSRS. The eC-SSRS is available in tablet, IVR and web versions and provides considerable benefits over the traditional C-SSRS. Although very simple and low burden to the patient, the eC-SSRS implements a complex systematic structure of questions that logically branch to appropriate follow-up questions based on patient responses. This self-reported approach increases patient candor and ensures consist deployment across all patients, at all sites, in all languages.  

By implementing the eC-SSRS in AVERT, sponsors benefit from:

  • Increased patient candor, resulting in greater clarity of patient risk
  • Elimination of clinician variability across sites, studies and languages
  • Reduced time and effort for site staff, allowing them to better focus their resources
  • Increased efficiency as a result of complete and immediate data capture, reporting, and alerting
  • Automatic assessment scoring eliminates potential clinician errors
  • Elimination of legibility issues and transcription errors
  • Elimination of costs for paper printing and shipping
  • Programmed error checking eliminates missing data problems, and ensures in-range responses
  • Web reports offers sponsors real-time insight into trial progress
  • Immediate alerts for at-risk patients facilitates proper and swift follow up
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  eC-SSRS Metrics (as of August 2014)

  • Implemented across multiple CNS and psychiatry indications including: Anxiety, Chronic Inflammatory Demyelinating Polyneuropathy, COPD, Depression, Epilepsy, Fibromyalgia, Hepatitis C, HIV, Insomnia, Migraine, Multiple Sclerosis, Pain, Oncology, Parkinson’s, PTSD, Restless Leg Syndrome
  • 200,000+ assessments
  • 45,000+ patients
  • 7,500+ patient care sites
  • 99%+ assessment completion rate
  • 75+ languages available
  • <1% “positive” findings in repeat assessments

The eC-SSRS is cited in the FDA Draft Guidance as an acceptable means of collecting Suicidal Ideation and Behavior (SIB) data. The first 35,000 and 75,000 eC-SSRS assessments were analyzed, published and cited in the guidance. You can access both these publications here: 35,000 eC-SSRS assessments 75,000 eC-SSRS assessments

Benefit from eliminating issues inherent in the collection of traditional paper-based assessments

The Clinician-Rated Digital C-SSRS

ERT has faithfully migrated the paper version of this instrument into an electronic format deployed on the AVERT platform. This digital implementation of the C-SSRS guides clinicians through the C-SSRS in an interview format and allows them to record the responses in an electronic format.  When capturing these data electronically, sponsors benefit from eliminating issues inherent in the collection of traditional paper-based assessments.

These benefits include:

  • Automatic assessment calculations eliminate clinician scoring errors
  • Elimination of legibility issues and transcription errors
  • Elimination of costs for paper printing, shipping and double data entry
  • Programmed error checking eliminates missing data and ensures in-range responses
  • Automatic assessment scoring eliminates potential clinician errors
  • On-screen help text assists personnel
  • Web reports offer sponsors real-time insight into trial progress
  • Immediate alerts for at-risk patients facilitates proper and immediate follow up