Can e-Health improve post-marketing surveillance of drugs and vaccines? The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised controlled trial.

In the current practice of adverse event reporting following immunisation, individuals can report any untoward symptoms to healthcare professionals (GP, hospital ED), Healthcare Direct phone helpline or the TGA. In the STARSS study, consenting subjects receiving routine immunisations will be randomised to the 3 arms of the trial after the immunisation encounter, according to a double-blind protocol. Two arms of the trial will evaluate two different SMS survey approaches to the follow-up of any medical events for up to 17 days following an immunisation. The third group will be the active control group, where the subjects will use the current usual practice of passive (voluntary) reporting of adverse events. The SMS survey is interactive, with the subjects receiving a response SMS to their notification of a medical event. Such response will contain two different texts depending on the intervention arm the subject is enrolled into. In the first intervention group, the SMS responders (eg the subjects reporting a medical event by return SMS) can report any untoward symptoms by visiting a healthcare professional, a hospital emergency department or by calling the Healthcare Direct helpline or the TGA for a health concern. In this intervention group, SMS responders confirming any contacts with a healthcare provider will be called by a nurse or a trained member of the study team within 24 hrs. These subjects will be administered a set questionnaire over the phone (CATI- "computer assisted telephone interview" group) to follow-up any medical events following the vaccination. Such follow-up will ascertain whether the symptoms for which medical attention was sought may be consistent with an adverse event. In the second intervention group, the SMS follow-up of medical events will use the same set questionnaire, but rather than receiving a follow-up telephone call, the subjects will receive a return SMS containing a link to the survey. In this modality, the questionnaire is web-based (WBR- "web based report" group), and the reporting of the medical event will be carried out by the subjects themselves. In this scenario, the answers to the questionnaire will be scanned automatically and in real-time against a set of pre-determined keywords and conditions to generate "flags" for follow-up. In both CATI and WBR groups, causality of any potential adverse events will be ascertained according the current WHO adverse event causality guidelines and reported as per common practice to the manufacturer, the TGA and the lead HREC . Typologies of SMS: In the intervention groups, an enrolment SMS will be sent out on day 1 (when vaccination is received) to all the subjects enrolled in both the “CATI” and the “WBR” groups. Such SMS will thank participants for entering the study and remind them to answer ‘yes’ if they seek any medical attention at any time thereafter. Following the enrolment SMS, 3 further identical reminder SMS are sent for post-vaccination surveillance on days 2, 7 and 14 reminding the intervention subjects to answer ‘yes’ if they seek any medical attention. A final SMS to mark the close of survey will be sent on day 17. 20% of all subjects enrolled will also be administered an acceptability questionnaire 1 month post-vaccination to evaluate public perception, assess large-scale feasibility and estimate the health economics aspects of the STARSS e-health based reporting processes.