title: Common cold symptoms in children: results of an Internet-based surveillance program.
abstract: 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.
authors.affiliation: Pfizer Consumer Healthcare, Global Clinical Development, Madison, NJ, United States. emanuel.troullos@pfizer.com.
authors.forename: Emanuel
authors.initials: E
authors.lastname: Troullos
authors.forename: Lisa
authors.initials: L
authors.lastname: Baird
authors.forename: Shyamalie
authors.initials: S
authors.lastname: Jayawardena
mesh_terms: D002648:Child; D003139:Common Cold / Q000150:complications / Q000175:diagnosis / Q000453:epidemiology*; D003371:Cough / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006306:Health Surveys; D006801:Humans; D020407:Internet; D008297:Male; D010612:Pharyngitis / Q000453:epidemiology / Q000209:etiology; D011159:Population Surveillance / Q000379:methods*; D015995:Prevalence; D063189:Symptom Assessment; D014481:United States / Q000453:epidemiology
keywords: common cold; pediatric; sleep; surveillance; symptoms