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A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging
Melissa S Stockwell1, Colin D Marchant2, A Patrica Wodi3
1Department of Pediatrics, Columbia University, 630 W. 168th St, New York, NY 10032, USA; Mailman School Public Health, Columbia University, 722 W. 168th St, New York, NY 10032, USA; NewYork Presbyterian Hospital, New York, NY 3959 Broadway, New York, NY 10032, USA.
Background:
Using text messaging for vaccine safety monitoring, particularly for non-medically attended events, would be valuable for pandemic influenza and emergency vaccination program preparedness. We assessed the feasibility and acceptability of text messaging to evaluate fever and wheezing post-influenza vaccination in a prospective, observational, multi-site pediatric study.
Methods:
Children aged 2-11 years old, with an emphasis on children with asthma, were recruited during the 2014-2015 influenza season from three community-based clinics in New York City, and during the 2014-2015 and 2015-2016 seasons from a private practice in Fall River, Massachusetts. Parents of enrolled children receiving quadrivalent live attenuated (LAIV4) or inactivated influenza vaccine (IIV4) replied to text messages assessing respiratory symptoms (day 3 and 7, then weekly through day 42), and temperature on the night of vaccination and the next seven nights (day 0-7). Missing data were collected via diary (day 0-7 only) and phone. Phone confirmation was obtained for both presence and absence of respiratory symptoms. Reporting rates, fever (T≥100.4 °F) frequency, proportion of wheezing and/or chest tightness reports captured via text message versus all sources (text, phone, diary, electronic health record) and parental satisfaction were assessed.
Results:
Across both seasons, 266 children were analyzed; 49.2% with asthma. Parental text message response rates were high (>70%) across sites. Overall, fever frequency was low (day 0-2: 4.1% [95% confidence interval (CI) 2.3-7.4%]; d3-7: 6.7% [95% CI 4.1-10.8%]). A third (39.2%) of parents reported a respiratory problem in their child, primarily cough. Most (88.2%) of the 52 wheezing and/or chest tightness reports were by text message. Most (88.1%) participants preferred text messaging over paper reporting.
Conclusions:
Text messaging can provide information about pediatric post-vaccination fever and wheezing and was viewed positively by parents. It could be a helpful tool for rapid vaccine safety monitoring during a pandemic or other emergency vaccination program.
Trial Registration:
clinicaltrials.gov Identifier: NCT02295007.
