Leveraging eC-SSRS for Suicide Risk Assessment

Discover how eC-SSRS is redefining suicide risk assessments with unprecedented accuracy and reliability in oncology trials and beyond

Libby Thomas – Scientific advisor, eCOA Science and Consulting at Clario 

Editor’s note: The following article is adapted from the recent webinar “Accurate Suicide Risk Detection With eC-SSRS Helps Ensure Safety of Trial Participants and Treatments in Oncology and Beyond.” Responses have been edited for clarity. You can watch the full webinar recording here. 

The Columbia-Suicide Severity Rating Scale (C-SSRS) and its electronic counterpart eC-SSRS are pivotal tools for understanding the nuanced emotions of trial participants, receiving endorsements from organizations like the Epilepsy Consortium as beacons of scientific rigor. Following in the footsteps of the first computer-automated assessment of suicidality introduced in 1973, the eC-SSRS delivers reliable data while helping patients feel more comfortable reporting the sensitive topic of suicide. The approach has even been recognized in regulatory arenas, establishing a reasonable standard that enables comfortable discussions around suicide without any fear of repercussion. 

Harnessing the eC-SSRS to encourage candor and reduce risks 

In clinical trials, ensuring inter- and intra-rater reliability and respondents’ honesty are vital elements in obtaining accurate clinical outcome assessment data. Maintaining high-quality data is notoriously difficult with various challenges ranging from logistics to biases, placebo effect and time pressures. 

Understandably, suicidal thoughts and behaviors are very sensitive topics to many patients, who may find a person-to-person interview with a rater to be uncomfortable or invasive. How a patient explains their thoughts and behavior to others versus their actual thoughts and behavior can often be inconsistent. Patients tend to conform to social norms when they are speaking with someone, like a rater, during a clinical study. They also demonstrate the social desirability bias, telling the rater what they think the rater wants to hear even if they are experiencing thoughts of suicide. 

By allowing patients to report their experience directly using an electronic device, the eC-SSRS reduces the frequency of interactions which may induce discomfort and social desirability-driven behavior. Patient responses are scored using the same algorithm each time, improving the quality and reliability of collected data by eliminating rater variance. 

In 2019, the Clario eCOA science team surveyed 73 patients with Alzheimer’s Disease, Mild Cognitive Impairment, and other dementias about their comfort and honesty reporting suicidal ideation and behavior during an in-person interview versus via electronic self-report. 92% of patients said they would be honest with an in-person healthcare provider, while 95% reported they would be honest in completing an electronic self-report.¹ The results suggest patients with a variety of cognitive conditions, while likely to report truthful answers regardless of interview modality, may be more likely to honestly self-report symptoms than when asked during a face-to-face interview. 

The reliability and power of eC-SSRS in oncology and beyond 

The eC-SSRS has demonstrated strength and reliability in detecting clear signals of patient suicide risk.² A robust measure, the eC-SSRS ensures safety for treatments under study, providing a sense of security and clarity for both patients and healthcare providers. The recommendations and acceptance from the FDA further echo its legitimacy, underscoring it as a recommended and acceptable tool in suicidality assessments. 

The eC-SSRS has proven to be a significant player for numerous medical issues ranging from heart ailments to weight loss drugs and –most notably–to anti-depressants. In the sphere of epilepsy, where the risk of suicide is heightened, eC-SSRS acts as a reliable bellwether, shielding patients while offering much-needed assistance to site staff. For instance, the Epilepsy Consortium has found the use of eC-SSRS to have reduced investigator burden and lowered the exclusion rate in studies from 20% to under 5%.³ 

More than a binary outcome of “yes or no” risk of suicide, the eC-SSRS has been designed to capture the nuanced spectrum of suicide and provide insight into the mindset of patients beyond the traditional therapeutic areas of neuroscience and dermatology. For example, cancer often has profound impacts on a patient’s mental health, impacting their quality of life and well-being. Through statistical analysis, one can untangle a relationship between suicide risk and domains such as quality of life, symptom severity, pain, and more. Ultimately, investigators have the potential to expand upon their findings by examining how the effects of the study medication are associated with risk of suicide.  

The eC-SSRS is more than just a system; it embodies a revolution in oncology trials and beyond, promising an age where the delicate topic of suicide is handled with the sensitivity and precision it demands, where patients find themselves supported and understood with scientifically backed care. 

Written by

Libby Thomas

Scientific advisor, eCOA Science and Consulting at Clario

Sources: 

¹ https://www.ijclinicaltrials.com/index.php/ijct/article/view/336 

² J.C. Mundt, J.H. Greist, A,J. Gelenberg, DJ Katzelnick, J.W. Jefferson, Jack G. Modell  

³ Hesdorffer, D. C., French, J. A., Posner, K., DiVentura, B., Pollard, J. R., Sperling, M. R., Harden, C. L., Krauss, G. L., & Kanner, A. M. (2013). Suicidal ideation and behavior screening in intractable focal epilepsy eligible for drug trials. Epilepsia, 54(5), 879–887. https://doi.org/10.1111/epi.12128