Tags

Type your tag names separated by a space and hit enter

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.

Links

  • PMC Free PDF
  • PMC Free Full Text
  • FREE Publisher Full Text
  • Authors+Show Affiliations

    ,

    Pfizer Consumer Healthcare, Global Clinical Development, Madison, NJ, United States. emanuel.troullos@pfizer.com.

    ,

    Source

    Journal of medical Internet research 16:6 2014 Jun 19 pg e144

    MeSH

    Child
    Common Cold
    Cough
    Female
    Health Surveys
    Humans
    Internet
    Male
    Pharyngitis
    Population Surveillance
    Prevalence
    Symptom Assessment
    United States

    Pub Type(s)

    Journal Article
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    24945090

    Citation

    Troullos, Emanuel, et al. "Common Cold Symptoms in Children: Results of an Internet-based Surveillance Program." Journal of Medical Internet Research, vol. 16, no. 6, 2014, pp. e144.
    Troullos E, Baird L, Jayawardena S. Common cold symptoms in children: results of an Internet-based surveillance program. J Med Internet Res. 2014;16(6):e144.
    Troullos, E., Baird, L., & Jayawardena, S. (2014). Common cold symptoms in children: results of an Internet-based surveillance program. Journal of Medical Internet Research, 16(6), pp. e144. doi:10.2196/jmir.2868.
    Troullos E, Baird L, Jayawardena S. Common Cold Symptoms in Children: Results of an Internet-based Surveillance Program. J Med Internet Res. 2014 Jun 19;16(6):e144. PubMed PMID: 24945090.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Common cold symptoms in children: results of an Internet-based surveillance program. AU - Troullos,Emanuel, AU - Baird,Lisa, AU - Jayawardena,Shyamalie, Y1 - 2014/06/19/ PY - 2013/09/12/received PY - 2014/04/09/accepted PY - 2014/6/20/entrez PY - 2014/6/20/pubmed PY - 2015/4/22/medline KW - common cold KW - pediatric KW - sleep KW - surveillance KW - symptoms SP - e144 EP - e144 JF - Journal of medical Internet research JO - J. Med. Internet Res. VL - 16 IS - 6 N2 - 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. SN - 1438-8871 UR - https://www.unboundmedicine.com/medline/citation/24945090/Common_cold_symptoms_in_children:_results_of_an_Internet_based_surveillance_program_ L2 - http://www.jmir.org/2014/6/e144/ DB - PRIME DP - Unbound Medicine ER -