The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is considered the gold standard for PTSD clinical trial assessments. It’s typically administered using a pencil-and-paper clinical interview. However, this approach can introduce errors and variability that compromise data integrity and the efficacy of signal detection in trials and increase the likelihood of trial failure.
To address these challenges, a group of expert clinicians developed an eCOA version of the CAPS-5. It was designed to streamline administration and scoring by offering guidance throughout the assessment process and automating the calculation of severity scores at various levels, tasks that have proven challenging with the traditional paper form.
This eCOA version does represent a significant improvement compared to the paper-based version, according to research presented at the 2024 International Society for CNS Clinical Trials and Methodology Scientific Meeting.
About the Study
To assess the effectiveness of this new electronic format, researchers compared traditional paper-based CAPS-5 administrations (n=195) against those conducted using eCOA (n=356) among clinical trial participants.
A team of calibrated reviewers analyzed these assessments for quality issues such as scoring and administration errors. To negate the influence of disease severity on the outcomes, the study also explored the relationship between CAPS-5 severity scores and the presence of quality issues in assessments.
Both rater groups received identical training that included a comprehensive tutorial on CAPS-5’s development, principles, interview techniques, and scoring methods.
What They Found
The findings were clear: Paper-based administrations of CAPS-5 had significantly more quality issues than eCOA administrations. The statistically significant difference highlights the potential for error with traditional pencil-and-paper methods.
Interestingly, the researchers found no significant correlation between the severity of a patient’s condition and the likelihood of an assessment having quality issues. This suggests that the method of administration plays a more critical role in ensuring the accuracy of CAPS-5 assessments.
Why It Matters
By substantially reducing the variability introduced by rater error, the eCOA version of CAPS-5 not only enhances the reliability of clinical trial outcomes but also minimizes the risk of trial failure due to inaccuracies in assessment. , The authors concluded, “The use of an electronic platform, with real-time guidance, automated scoring, and other features, can help standardize scale administration and scoring, substantially reducing error variance and improving signal detection.”
References
- Conrad E, Chinn N, Blattner N, Negash S, Poppe C, Opler M. Improving Administration and Scoring in CAPS-5. Poster presented at the International Society for CNS Clinical Trials and Methodology meeting (2024)
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