Trial Assesses the Effectiveness of an AI-Powered Diagnostic Tool for Early Detection of PTSD

Trialize AG, a clinical trials automation company, in collaboration with Health Level Seven International (HL7) Ukraine, is conducting a study to identify mental health disorder symptoms among Ukrainian citizens affected by the ongoing conflict. The trial assesses the effectiveness of an AI-powered diagnostic tool designed to significantly improve the sensitivity and specificity of existing measures, with the potential to replace them in the future.

The adaptive design study aims to enroll 10,000 Ukrainian citizens, including those displaced by the war. Biometric onboarding technology has been employed to optimize the pre-screening and consenting process for a large number of remote participants. The platform offers tele-visits and e-consent functionality, capturing unstructured data such as voice and video recordings, along with traditional data points via its EDC and EPRO modules. This allows for in-depth analytical insights through the application of advanced data science techniques.

A quota sampling approach was implemented to achieve a representative sample in terms of age, sex, and region of Ukraine before the Russian invasion. Participants were reached using various online platforms, email, and partner NGOs. Each participant received a digital invitation and provided electronic informed consent. The study has been approved by the Institutional Review Boards.

An estimated sample of 9,700 participants is required to detect moderate effect sizes of 0.6, with 99% power and a 1% significance level. So far, 4,167 participants have been recruited and screened.

Preliminary results indicate:
* 18% failed to meet inclusion criteria
* 4.3% dropped out
* 18.3% prevalence of PTSD based on cumulative scores of self-assessment instruments
* 13.5% confirmed PTSD following structured clinical interviews with practitioners

The incorporation of an AI-screening panel into self-assessment tools has yielded promising outcomes: a 27.4% improvement in sensitivity and a 63.2% enhancement in specificity.

HL7 Ukraine is the Ukrainian chapter of Health Level Seven International (HL7 International), a non-profit organization that develops standards for the exchange, integration, sharing, and retrieval of electronic health information.

HL7 Ukraine is responsible for promoting the adoption and implementation of HL7 standards within the Ukrainian healthcare system, as well as providing education, training, and support to local stakeholders. They work with healthcare providers, government agencies, and technology vendors to ensure that healthcare data is accurate, complete, and accessible across different systems and platforms.

Trialize is a software company that provides a automation platform for decentralized, hybrid and virtual clinical trials. Their platform enables the remote and virtual conduct of clinical trials, which can improve patient participation, reduce trial costs, and accelerate the development of new treatments.

The Trialize platform includes modules for patient recruitment and screening, remote and on-site data capture, patient engagement, and more. It also integrates with various wearable devices and sensors, allowing for the collection of real-world data during clinical trials.

Trialize is headquartered in Zug, Switzerland, and was founded in 2020. They work with pharmaceutical and biotech companies, CROs, and academic research institutions, and have experience in a range of therapeutic areas, including oncology, neurology, and rare diseases.


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