Article thumbnail

Redesigning a large school-based clinical trial in response to changes in community practice

By Lynn B Gerald, Joe K Gerald, Leslie A McClure, Kathy Harrington, Sue Erwin and William C Bailey


Background Asthma exacerbations are seasonal with the greatest risk in elementary-age students occurring shortly after returning to school following summer break. Recent research suggests that this seasonality in children is primarily related to viral respiratory tract infections. Regular hand washing is the most effective method to prevent the spread of viral respiratory infections; unfortunately, achieving hand washing recommendations in schools is difficult. Therefore, we designed a study to evaluate the effect of hand sanitizer use in elementary schools on exacerbations among children with asthma

Topics: Design
Publisher: SAGE Publications
OAI identifier:
Provided by: PubMed Central

To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.

Suggested articles


  1. (2005). A randomized, controlled trial of a multifaceted intervention including alcohol-based hand sanitizer and hand-hygiene education to reduce illness transmission in the home. Pediatrics
  2. (2004). A systematic review of the effectiveness of antimicrobial rinse-free hand sanitizers for prevention of illness-related absenteeism in elementary school children. BMC Public Health
  3. (2002). Achieving guideline-based asthma control: does the patient benefit? Eur Respir J
  4. (2000). Alcohol-free instant hand sanitizer reduces elementary school illness absenteeism. Fam Med
  5. (2005). An unusual complication of hand hygiene. Anaesthesia
  6. (2007). Benzalkonium chloride (BAC) and dimethyldioctadecyl-ammonium bromide (DDAB), two common quaternary ammonium compounds, cause genotoxic effects in mammalian and plant cells at environmentally relevant concentrations. Mutagenesis
  7. (1995). Community study of role of viral infections in exacerbations of asthma in 9-11 year old children. BMJ
  8. (2007). Comparing hand washing to hand sanitizers in reducing elementary school students’ absenteeism. Pediatr Nurs
  9. (1999). Detection of viral, Chlamydia pneumoniae and Mycoplasma pneumoniae infections in exacerbations of asthma in children.
  10. (2010). Disease Control and Prevention. Clean Hands Saves Lives!;
  11. (2002). Disease Control and Prevention. Guideline for hand hygiene in health-care settings: recommendations of the healthcare infection control practices advisory committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR
  12. (2007). Effect of chlorhexidine and benzalkonium chloride on bacterial biofilm formation. Lett Appl Microbiol
  13. (2000). Effect of hand sanitizer use on elementary school absenteeism.
  14. (1998). Effect of several interventions on the frequency of handwashing among elementary public school children.
  15. (2001). Effectiveness of a nonrinse, alcohol-free antiseptic hand wash.
  16. (1986). Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. Prev Med.
  17. (2002). Flash fire associated with the use of alcohol-based antiseptic agent.
  18. (2007). Flexural allergic contact dermatitis to benzalkonium chloride in antiseptic bath oil.
  19. (1994). Health and Human Services Food and Drug Administration. Tentative final monograph for health-care antiseptic drug products: proposed rule. Fed Regist
  20. (2004). Healthy hands: use of alcohol gel as an adjunct to handwashing in elementary school children.
  21. (2007). Human skin in organ culture and human skin cells (keratinocytes and fibroblasts) in monolayer culture for assessment of chemically induced skin damage. Toxicol Pathol
  22. (2005). Illness transmission in the home: a possible role for alcoholbased hand gels. Pediatrics
  23. (2009). Increasing adherence to inhaled steroid therapy among schoolchildren: randomized, controlled trial of school-based supervised asthma therapy. Pediatrics
  24. (2010). Inspections of hand washing supplies and hand sanitizer in public schools.
  25. (2009). Physical interventions to interrupt or reduce the spread of respiratory viruses: systematic review. BMJ
  26. (2001). Reduction of illness absenteeism in elementary schools using an alcohol-free instant hand sanitizer.
  27. (1985). Relapse Prevention: Maintenance Strategies in the Treatment of Addictive Behaviors.
  28. (1996). Respiratory infections and the autumn increase in asthma morbidity.
  29. (1998). Review of community-based research: assessing partnership approaches to improve public health. Ann Rev Pub Health
  30. (1999). Rhinovirus and respiratory syncytial virus in wheezing children requiring emergency care. IgE and eosinophil analyses. Am J Respir Crit Care Med
  31. (2003). Role of viruses and atypical bacteria in exacerbations of asthma in hospitalized children: a prospective study in 318 LB Gerald et al. Clinical Trials 2011; 8: 311–319 http://ctj.sagepub.comthe Nord-Pas de Calais region (France). Pediatr Pulmonol
  32. (1998). Testing a new alcohol-free hand sanitizer to combat infection.
  33. (1998). The action of three antiseptics/ disinfectants against enveloped and non-enveloped viruses.
  34. (2002). The changing role of the school nurse: a partner in infection control and disease prevention.
  35. (2002). The effect of a comprehensive handwashing program on absenteeism in elementary schools.
  36. (2003). The effect of hand hygiene on illness rate among students in university residence halls.
  37. (2001). The effectiveness of interventions aimed at increasing handwashing in healthcare workers – a systematic review. J Hosp Infect
  38. (2007). The impact of inadequately controlled asthma in urban children on quality of life and productivity. Ann Allergy Asthma Immunol
  39. (2005). The relationship of fall school opening and emergency department asthma visits in a large metropolitan area. Arch Pediatr Adolesc Med
  40. (2002). The seasonality of rhinovirus infections and its implications for clinical recognition. Clin Ther
  41. (2005). The September epidemic of asthma exacerbations in children: a search for etiology.
  42. (1980). The state of childhood asthma, United States,
  43. (2002). Trends in childhood asthma: prevalence, health care utilization, and mortality. Pediatrics
  44. (2002). Using seasonal variations in asthma hospitalizations in children to predict hospitalization frequency.