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Common cold symptoms in children: results of an Internet-based surveillance program
Emanuel Troullos1, Lisa Baird, Shyamalie Jayawardena
1Pfizer Consumer Healthcare, Global Clinical Development, Madison, NJ, United States. emanuel.troullos@pfizer.com.
Insights
Internet-based surveillance effectively recruited children for clinical studies on common cold symptoms. This method shows promise for pediatric research, though careful study design is needed to manage potential participant dropout.
Area of Science:
- Pediatric Clinical Trials
- Digital Health Surveillance
- Respiratory Illness Research
Background:
- Clinical studies for pediatric cough and cold medications face recruitment challenges due to symptom variability.
- Internet-based surveillance offers a novel approach for identifying and enrolling pediatric subjects in clinical studies.
- Assessing the safety and efficacy of cough and cold ingredients in children aged 6-11 years necessitates effective recruitment strategies.
Purpose of the Study:
- To develop an Internet-based surveillance system for pediatric clinical studies.
- To evaluate the feasibility of using this system for recruiting children with common cold symptoms.
- To record the natural history of cold symptoms and assess parental willingness for clinical study participation.
Main Methods:
- Recruited healthy pediatric subjects (6-11 years) via online parental contact.
- Utilized daily online surveys for parents to report child's cold symptoms over a 6-week period.
- Tracked symptom progression for 10 days if a cold developed and assessed parental willingness for study participation.
Main Results:
- Achieved enrollment target of 248 children within one week, recruiting from four US regions.
- Identified 134 children who developed colds, with prevalent symptoms including runny nose, nasal congestion, and sneezing.
- Found that 54% of parents were willing to enroll their sick child in a clinical study; surveys were reported as easy to complete.
Conclusions:
- Internet-based surveillance and recruitment are viable tools for pediatric cold studies.
- This approach can effectively track illness and enroll participants for clinical trials.
- Future study designs must address potential high dropout rates and adherence challenges.
Background:
Conducting and analyzing clinical studies of cough and cold medications is challenging due to the rapid onset and short duration of the symptoms. The use of Internet-based surveillance tools is a new approach in clinical studies that is gradually becoming popular and may become a useful method of recruitment. As part of an initiative to assess the safety and efficacy of cough and cold ingredients in children 6-11 years of age, a surveillance program was proposed as a means to identify and recruit pediatric subjects for clinical studies.
Objective:
The objective of the study was to develop an Internet-based surveillance system and to assess the feasibility of using such a system to recruit children for common cold clinical studies, record the natural history of their cold symptoms, and determine the willingness of parents to have their children participate in clinical studies.
Methods:
Healthy potential subjects were recruited via parental contact online. During the 6-week surveillance period, parents completed daily surveys to record details of any cold symptoms in their children. If a child developed a cold, symptoms were followed via survey for 10 days. Additional questions evaluated the willingness of parents to have their children participate in a clinical study shortly after onset of symptoms.
Results:
The enrollment target of 248 children was reached in approximately 1 week. Children from 4 distinct geographic regions of the United States were recruited. Parents reported cold symptoms in 163 children, and 134 went on to develop colds. The most prevalent symptoms were runny nose, stuffed-up nose, and sneezing. The most severe symptoms were runny nose, stuffed-up nose, and sore/scratchy throat. The severity of most symptoms peaked 1-2 days after onset. Up to 54% of parents expressed willingness to bring a sick child to a clinical center shortly after the onset of symptoms. Parents found the Internet-based surveys easy to complete.
Conclusions:
Internet-based surveillance and recruitment can be useful tools to follow colds in children and enroll subjects in clinical studies. However, study designs should account for a potentially high dropout rate and low rate of adherence to study procedures.
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