Comparison of text-messaging to voice telephone interviews for active surveillance of adverse events following immunisation

Regan, Annette K.; Blyth, Christopher C; Tracey, Lauren; Mak, Donna B; Richmond, Peter; Effler, Paul V.

doi:10.1016/j.vaccine.2015.06.022

Cited by 20 publications

(36 citation statements)

References 21 publications

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“…Response rate (84.6%) was consistent with literature data: in a recent study published by Regan A.K. et al, response rate to text messaging and oral voice telephone interviews for AEFIs detection ranged between 63.9% and 90.1%, depending on the age and sociodemographic characteristics of the enrolled people [36,37].…”

Section: Discussionsupporting

confidence: 87%

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017–2018

et al. 2019

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Since 2012, the Italian Ministry of Health has recommended to improve the surveillance of adverse events following the measles-mumps-rubella-varicella (MMRV) tetravalent vaccine that was provided in the official immunization schedule of some Italian regions for children during the second year of life. This recommendation was based on data from some surveys that showed an additional risk of seizure following the administration of this vaccine. Responding to the Ministry commitment, the Puglia Region launched, from May 2017 to November 2018, a post-marketing active surveillance program of adverse events following MMRV immunization (AEFIs). Immunized children (second year of life) were enrolled on a voluntary basis, AEFIs diaries were used, and their parents were interviewed 25 days after the immunization. There were 2540 children enrolled; 2149/2540 (84.6%) completed the post-vaccination follow-up. Of these, 992 AEFIs were registered with a reporting rate of 46.2 × 100 doses: 883/992 (89.0%) AEFIs were not serious, while 109/992 (11.0%) were serious. For serious AEFIs, the evaluation of causality assessment was performed using the algorithm proposed by the World Health Organisation (WHO): 82/109 consistent causal associations to MMRV immunization were detected (reporting rate of consistent AEFIs: 3.8 × 100 follow-up). All serious AEFIs consistently associated with immunization resulted completely resolved at the follow-up. The reporting rate of seizure consistently associated with immunization was 0.05 × 100, lower than data previous published in the literature that did not report the causality assessment. Because no emerging signals were detected, our data from the active surveillance program confirmed the safety profile of the MMRV vaccine.

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Section: Discussionsupporting

confidence: 87%

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017–2018

et al. 2019

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“…In Australia, the AusVaxSafety surveillance system that uses integrated software to identify and issue automated surveys via text messaging provides active near real-time surveillance capable of rapid data collection on a national level. 41 The FAST-Mum program has monitored the trivalent influenza vaccine safety in pregnant women in Western Australia since 2012, 42 while Vaxtracker (also web-based) monitors inactivated influenza vaccine in children in New South Wales. 43 In Canada, text messaging has been introduced in the CANVAS network as an alternative to conventional telephone interviews.…”

Section: Changes To Ema Guidancementioning

confidence: 99%

“…41 Australia Text messaging Text messaging was introduced in the active surveillance FAST-Mum programme in pregnant women in 2013 as an alternative to telephone interview In one survey, more women responded to text messaging (90%) than to telephone interview (67%). 42 Timeliness of data collection was improved with text messaging. Despite the higher response rate with text messaging, women surveyed by this method were less likely to report an AEFI than women surveyed by telephone, with the greatest discrepancies being for injection site reactions and unsolicited events.…”

Section: Countrymentioning

confidence: 99%

Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives

Santos¹

2019

Human Vaccines & Immunotherapeutics

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Seasonal influenza vaccines are frequently reformulated, leading to specific challenges for continuous benefit/risk monitoring. In 2014, the European Medicines Agency started requiring annual enhanced safety surveillance (ESS). This article provides a perspective on ESS studies conducted ever since and aims to map existing initiatives used to monitor adverse events following influenza immunization. Of 11 ESS studies, reporting surveillance data of at least five different vaccine brands during four seasons, all were able to rapidly capture vaccine-specific adverse events of interest reports. However, challenges have been identified during study implementation, including recruitment of sufficient participants, enrolling younger age groups, collecting data of vaccine batch numbers, comparing observed with expected rates and achieving adequate return of reported events. Harmonizing safety monitoring standards across countries, and bridging between routine pharmacovigilance and ESS, is likely to allow more comprehensive assessments of influenza vaccine safety, requiring close collaboration between regulators, public health, and manufacturers.

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“…Researchers may prompt participants to submit repeated measures data by texting a direct response, linking to a survey, or logging into another platform to enter the data [1,5,6]. Direct response eliminates a step and may yield better response rates.…”

Section: The Text Messagementioning

confidence: 99%

“…A participant who cannot ensure they are the only users of a cell phone, especially when sensitive data will be requested, may not be the best candidate to report data via text messages. Suggestions for minimizing security breaches include providing minimal identifying information to the text message vendor, allowing participants to create an alias if messages will address the recipient by name [5], encouraging participants to password-protect access to their phone [5,17], and recommending participants delete the text messages after responding [17].…”

Section: The Phonementioning

confidence: 99%

Best practices for collecting repeated measures data using text messages

Shimoni

Nippita

Castaño

2020

BMC Med Res Methodol

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Background: Researchers and clinicians use text messages to collect data with the advantage of real time capture when compared with standard data collection methods. This article reviews project setup and management for successfully collecting patient-reported data through text messages. Methods: We review our experience enrolling over 2600 participants in six clinical trials that used text messages to relay information or collect data. We also reviewed the literature on text messages used for repeated data collection. We classify recommendations according to common themes: the text message, the data submitted and the phone used. Results: We present lessons learned and discuss how to create text message content, select a data collection platform with practical features, manage the data thoughtfully and consistently, and work with patients, participants and their phones to protect privacy. Researchers and clinicians should design text messages to include short, simple prompts and answer choices. They should decide whether and when to send reminders if participants do not respond and set parameters regarding when and how often to contact patients for missing data. Data collection platforms send, receive, and store messages. They can validate responses and send error messages. Researchers should develop a protocol to append and correct data in order to improve consistency with data handling. At the time of enrollment, researchers should ensure that participants can receive and respond to messages. Researchers should address privacy concerns and plan for service interruptions by obtaining alternate participant contact information and providing participants with a backup data collection method. Conclusions: Careful planning and execution can reward clinicians and investigators with complete, timely and accurate data sets.

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Comparison of text-messaging to voice telephone interviews for active surveillance of adverse events following immunisation

Cited by 20 publications

References 21 publications

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017–2018

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017–2018

Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives

Best practices for collecting repeated measures data using text messages

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