Aims of the STARSS Study
STARSS is the acronym for "Stimulated Telephone-Assisted Rapid Safety Surveillance".
This Study is the first large-scale randomised controlled trial in Australia evaluating real-time vaccine safety surveillance of patients of all ages receiving any vaccination.
In Australia, adverse events are reported to the Therapeutics Goods Administration (TGA) by the patient or on behalf of the patient by a healthcare professional. This way of reporting adverse events is called “passive” reporting.
The primary objective of the Study is to rigorously evaluate a real-time stimulated reporting system using e-health technology to contact patients after a vaccination. The STARSS system is able to detect adverse events in a more effective and timely manner than with the current practice of passive reporting. The Study will also evaluate the feasibility and public response to the use of the system.
After the vaccination, STARSS sends SMS reminder texts to 2 out of 3 participants, asking if they have requested health advice such as visiting a GP, nurse or hospital emergency department or calling Healthdirect after their vaccination. When participants who received such SMS texts reply "Yes" to confirm they asked for health advice, they will be subsequently followed up by either a nurse phone call or they may be asked to complete a web survey over the phone.
The Novel Approach of STARSS
Making sense of vaccine safety data is challenging because the systems used to collect it are not always connected to one another and are scattered across the country.
A number of studies to date have demonstrated the usefulness of SMS technology for vaccine safety monitoring. However, the lack of inter-connectivity between GP practices and state health surveillance systems, compounded by the lack of an automated and real-time data extraction solution applicable to all available vaccinations have hampered the systematic collection of vaccine safety surveillance data across Australia.
STARSS overcomes these problems by using a new system where the vaccination data is automatically extracted and then automatically brought together for analysis at the University of Adelaide.
STARSS is the first advanced e-health platform which combines the most advanced health data extraction technology to perform automated vaccination data extraction of any type of licensed vaccination combined with powerful surveying capabilities able to detect when and which type of health advice was sought after vaccination.
The STARSS system can detect a report very quickly: if a participant reports seeking health advice after vaccination by speaking to a GP/nurse, visiting the hospital emergency department or by calling Healthdirect, the STARSS system is able to record the details of the event and elaborate a response to the participant within the next hour.
The STARSS system is also capable of dealing with the follow-up of reports which are subsequently reviewed by a state health nurse.
The other advantage of the STARSS system is that the vaccine safety surveillance data travels encrypted to a single repository, achieving the model of streamlined connectivity which could be adopted Australia-wide in the future for the safety surveillance of vaccines.
Potential Future Applications
The innovative aspects of the STARSS system don't just stop at the safety surveillance of vaccines. The technology can be customised for the safety surveillance of drugs in general and can revolutionise the way we monitor new interventions, therapies and devices across Australia.