Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study.

INTRODUCTION: Post-licensure surveillance of adverse events following immunisation (AEFI) is critical for detecting rare but severe AEFI. SmartVax software, using smartphone technology, actively solicits reports of AEFI via automated, opt-out SMS surveys to vaccine recipients in the days following immunisation. We report on a pilot study to test the feasibility and acceptance of SmartVax in Switzerland. METHODS: Between February and September 2020, consecutive subjects immunised at an adult immunisation clinic and the employee health service at the University Hospital of Basel were screened. Participants included three subgroups: healthcare workers (HCW), subjects with immune-mediated inflammatory diseases (IMID) and clients of the regular adult immunisation clinic. Three days after vaccination, participants received an SMS inquiring if they had any AEFI. In the case of an AEFI, subjects received an automated SMS with a link to an online survey assessing the type and temporal evolution of the AEFI. Descriptive statistics of response rate, time-to-response, frequency and type of AEFI by vaccine and clinical subgroup were performed. RESULTS: Of 293 subjects screened, 276 were included (46.6% routine vaccination check-up visits, 33.3% HCW, 20.1% IMID patients) receiving 625 vaccinations during 360 immunisation visits. The SMS response rate was high (90.3%), with a median time-to-respond of 47 minutes (interquartile range11-205). After 29.8% of immunisation visits at least one AEFI was reported. There were no differences in frequency or type of AEFI between the three clinical subgroups. The recombinant, adjuvanted zoster vaccine Shingrix® was associated with the highest rate of local and systemic reactions. CONCLUSION: Monitoring post-licensure vaccine safety using the active SMS-based surveillance system SmartVax is feasible in Switzerland. We observed a high acceptance in the diverse study population, including healthcare workers and IMID patients. High response rates in the elderly and reliable monitoring almost in real-time make SmartVax a promising tool for COVID-19 vaccine safety monitoring.

Symptom profile of patients receiving antibiotics for upper respiratory tract infections in general practice: an observational study using smartphone technology.

BACKGROUND: Upper respiratory tract infections (URTIs) are a common presentation in general practice and are linked to high rates of inappropriate antibiotic prescription. There is limited information about the trajectory of patients with this condition who have been prescribed antibiotics. OBJECTIVE: To document the symptom profile of patients receiving antibiotics for URTIs in Australian general practice using smartphone technology and online surveys. METHODS: In total, 8218 patients received antibiotics after attending one of the 32 general practice clinics in Australia from June to October 2017: 4089 were identified as URTI presentations and were the cohort studied. Patients completed the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) 3 and 7 days after visiting their general practitioner (GP). RESULTS: Six hundred fourteen URTI-specific patients responded to at least one symptom survey (RR 15%). The majority of patients reported moderate to mild symptoms at 72 hours [median global symptom severity score 37 (IQR 19, 59)] post-GP visit which reduced to very mild symptoms or not sick by day 7 [11 (IQR 4, 27)]. Patients receiving antibiotics for URTI reported the same level of symptom severity as patients in previous studies receiving no treatment. CONCLUSIONS: The recovery of most patients within days of receiving antibiotics for URTI mimics the trajectory of patients with viral URTIs without treatment. Antibiotics did not appear to hasten recovery. Monitoring of patients in this context using smart phone technology is feasible but limited by modest response rates.

Using automated text messages to monitor adverse events following immunisation in general practice.

OBJECTIVE: To assess the performance of SmartVax, a prototypic active monitoring system for adverse events following immunisation (AEFI) using short message service (SMS) text messages and clinical data extracted from commercially available medical practice management software. DESIGN, SETTING AND PARTICIPANTS: Between 11 November 2011 and 10 June 2013, adult patients and parents of paediatric patients receiving routine vaccinations in general practice were sent an SMS by SmartVax enquiring if they had experienced any AEFI and requesting a reply by SMS. Attempts were made to telephone patients who did not reply by SMS. MAIN OUTCOME MEASURES: The proportion of patients sent an SMS who replied by SMS, and the proportion of respondents indicating possible AEFI. RESULTS: Of 3281 vaccinated patients, 3226 (98.3%) had a mobile telephone number on record and were sent an SMS. Of 2342 patients (72.6%; 95% CI, 70.0%-75.1%) who responded by SMS, 264 (11.3%; 95 CI, 9.9%-12.7%) reported possible AEFI. The response rate was ≥ 70% for both paediatric and adult patients. Eighty-per cent of SMS replies were received within 2 hours of transmission of the query SMS. There was no significant difference in the proportion reporting possible AEFI between patients who replied by SMS and those who did not respond by SMS but were subsequently contacted by a telephone call (P = 0.99). CONCLUSIONS: More than 70% of patients responded by SMS to an SMS query about whether they had any vaccine reactions, with the data received in near real-time. Active surveillance of AEFI using SMS has the capacity to complement existing passive reporting systems, potentially permitting more rapid identification of emerging safety signals.