J. Med. Internet Res. - Common cold symptoms in children: results of an Internet-based surveillance program.

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Resumo

CKGROUND: 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.

Resumo Limpo

ckground conduct analyz clinic studi cough cold medic challeng due rapid onset short durat symptom use internetbas surveil tool new approach clinic studi gradual becom popular may becom use method recruit part initi assess safeti efficaci cough cold ingredi children year age surveil program propos mean identifi recruit pediatr subject clinic studiesobject object studi develop internetbas surveil system assess feasibl use system recruit children common cold clinic studi record natur histori cold symptom determin willing parent children particip clinic studiesmethod healthi potenti subject recruit via parent contact onlin week surveil period parent complet daili survey record detail cold symptom children child develop cold symptom follow via survey day addit question evalu willing parent children particip clinic studi short onset symptomsresult enrol target children reach approxim week children distinct geograph region unit state recruit parent report cold symptom children went develop cold preval symptom runni nose stuffedup nose sneez sever symptom runni nose stuffedup nose sorescratchi throat sever symptom peak day onset parent express willing bring sick child clinic center short onset symptom parent found internetbas survey easi completeconclus internetbas surveil recruit can use tool follow cold children enrol subject clinic studi howev studi design account potenti high dropout rate low rate adher studi procedur

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