Efficacy of m-Health for the detection of adverse events following immunization – The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial. Issue 2 (8th January 2021)

• Record Type: Journal Article
• Authors: Gold, M.S.; Lincoln, G.; Cashman, P.; Braunack-Mayer, A.; Stocks, N.
• Is Part Of: Vaccine. Volume 39:Issue 2(2021)
• Page Start: 332
• Page End: 342
• Publication Date: 2021-01-08
• Subjects: Adverse events following immunisation -- Vaccine safety surveillance -- Pharmacovigilance -- m-Health; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2020.11.056
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Introduction: Passive surveillance is recommended globally for the detection of adverse events following immunisation (AEFI) but this has significant challenges. Use of Mobile health for vaccine safety surveillance enables a consumer-centred approach to reporting. The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) a randomised control trial (RCT) sought to evaluate the efficacy and acceptability of SMS for AEFI surveillance. Methods: Multi-centre RCT, participants were adult vaccinees or parents of children receiving any vaccine at a trial site. At enrolment randomisation occurred to one of two SMS groups or a control group. Prompts on days 2, 7 and 14 post-immunisation, were sent to the SMS group, to ascertain if a medical event following immunisation (MEFI) had occurred. No SMS's were sent to the control participants. Those in the SMS who notified an MEFI were pre-randomised to complete a computer assisted telephone interview or a web based report to determine if an AEFI had occurred whilst an AEFI in the controls was determined by a search for passive reports. The primary outcome was the AEFI detection rate in the SMS group compared to controls. Results: We enrolled 6, 338 participants, who were equally distributed across groups and who received 11, 675 vaccines. The SMS group (4, 225) received 12, 675 surveillance prompts with 9.8% being non-compliant and not responding. In those that responded 90% indicated that no MEFI had been experienced and 184 had a verified AEFI. 6 control subjects had a reported AEFI. The AEFI detection rate was 13 fold greater in the SMS group when compared with controls (4.3 vs 0.3%). Conclusion: We have demonstrated that the STARSS methodology improves AEFI detection. Our findings should inform the wider use of SMS-based surveillance which is particularly relevant since establishing robust and novel pharmacovigilance systems is critical to monitoring novel vaccines which includes potential COVID vaccines.