Table 2.
Data collection activities, the Pregnancy and Influenza Multinational Epidemiologic Study
| Data collection activity | Enrollment | Pregnancy | Delivery/end of Pregnancy | Postpartum (6–8 weeks after end of pregnancy) | At any time point |
|---|---|---|---|---|---|
| Enrollment interviewa | X | ||||
| Designation of proxyb | X | ||||
| Orientation to illness reporting activitiesc | X | ||||
| How to report ILS episodes | |||||
| Symptom diary card | |||||
| Digital thermometer use | |||||
| Self swabbing (Thailand only) | |||||
| Knowledge, attitudes and practices survey | X | ||||
| Ultrasound data collection formd | X | ||||
| Whole blood collection (serology sub-study participants)e | (X) | (X) | |||
| Twice weekly surveillance contacts to identify ILS and delivery/end of pregnancyf | X | ||||
| If ILS identified: | |||||
| Symptom screening logg | (X) | ||||
| Illness follow-up interviewh | (X) | ||||
| Respiratory specimen collectioni | (X) | ||||
| Delivery/end of pregnacy interviewj | X | ||||
| Birth weight data collection formk | X | ||||
| Postpartum interviewl | X | ||||
| Influenza vaccination verificationm | (X) | ||||
| End of pregnancy/delivery chart abstractionn | X | ||||
| Acute hospitalization chart abstractiono | (X) | ||||
| Death reporting form | (X) | ||||
| Withdrawal form | (X) |
ILS: Influenza like symptoms defined as new onset or sudden worsening of one or more of the following symptoms: myalgia, cough, runny nose or nasal congestion, sore throat, or difficulty breathing
Parentheses indicate activities that only occur for certain participants
a The enrollment interview collects information on socio-demographic characteristics, past medical and pregnancy history, and prenatal care for the current pregnancy
b During the enrollment process, each participant is asked to designate one or more proxies who may provide certain information about the participant’s health and pregnancy if she is not reachable by study staff. Study staff contact the participants’ proxy(ies) in the following situations: 1) if they are unable to reach the participants for twice weekly surveillance contacts after three attempts, 2) if they are unable to reach the participants for the end-of-pregnancy interview or post-partum interview, or 3) in the event of participant death reported by other sources (e.g. hospital staff)
c All participants receive a study orientation that emphasizes that the study aims to capture all potential respiratory illness episodes during participants’ pregnancies, accurately measure body temperature during illness episodes, and capture pregnancy outcomes such as infants’ birth weights as close to delivery as possible. They are given information about how to contact study staff with questions or notify them of an ILS episode, digital thermometers and symptom diary cards with instruction on using these items during ILS episodes. At the Bangkok site, instruction and demonstration on preforming self-collection of a mid-turbinate nasal swab (i.e., “self-swab”) and “swabbing kits” are also provided
d All participants have an ultrasound data collection form completed close to the time of enrollment. The form collects information on the parameters used for gestational age dating and the estimated gestational age in weeks and days
e Sites in Lima and Bangkok participate in a serology sub-study in which the sites aim to enroll 700 women per year to have whole blood collected at enrollment and within 7 days after the end of pregnancy to assess seroconversion to circulating strains during pregnancy
f Study staff contact participants twice weekly throughout their pregnancies to ascertain whether women have experienced ILS or end of pregnancy. Contacts are made by telephone call, messaging application or home visit
g If a participant reports an illness potentially meeting ILS criteria, staff conduct a symptom screening log to confirm illness symptoms and time since symptom onset
h Participants with confirmed ILS episodes are contacted starting seven days after illness onset (and every other day up through 13 days after illness onset) to determine when the ILS has ended. Once they report that their ILS has ended or it is 13 days after symptom onset, they complete an illness follow-up interview in person or by telephone that collects information on symptoms and subjective severity, duration of fever and height of highest measured temperature, missed work and/or absence from daily activities, receipt of medical care, and use of antiviral or antibiotic prescriptions
i Participants whose ILS episodes began within the past 7 days have a mid-turbinate nasal swab collected for influenza virus testing within 24 h of illness report. Participants at the Bangkok site self-collect their swabs
j Study staff administer a questionnaire within 7 days after delivery or end of pregnancy to collect information on prenatal course and delivery outcomes
k If participants deliver in a study hospital or clinic, infants are weighed on the day of delivery with study-approved digital scales. If participants deliver at a non-study hospital or at home, study staff attempt to visit the woman on the day of delivery (but no later than 48 h after delivery), when feasible, to measure the infant’s birth weight using study digital scales. In the minority of instances when a particpiant delivers at a non-study hospital and study staff cannot visit the woman, weights are abstracted from available medical records. All weights are recorded to the nearest gram
l The postpartum interview is conducted at 6–8 weeks after end of pregnancy and collects information on postpartum and neonatal course
m For participants who report receiving influenza vaccination, study staff attempt to verify vaccination status against medical records or vaccine registries
n Study staff abstract information from any available medical records on prenatal care, pregnancy course, and delivery/perinatal outcomes
o If a woman is hopitalized during her pregnancy for reasons other than delivery, study staff attempt to abstract information on the acute hospitalization from available medical records