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Table 2 Quality assessment of trials meeting inclusion criteria

From: A systematic review of the effectiveness of antimicrobial rinse-free hand sanitizers for prevention of illness-related absenteeism in elementary school children

Author(s), Year, and Country Quality Assessment Allocation Concealment Additional Comments
Cluster RCT
White 41 2001 United States Study was described as randomized however did not explain method of randomization; participants and study-coordinators were blinded; description of withdrawals and dropouts provided: of the 72 initial classes (1626 students), 32 classes (16 target and 16 control; 769 students) participated (remainder dropped from analysis) Unclear Sample size calculation not defined; statistical methods unclear; parents required to sign detailed informed consent form; study reviewed and approved by the two school boards; soap and handwashing not monitored; clustering not accounted for
Crossover
Dyer 27 2000 United States Study was not formally randomized; neither participants or study-coordinators were blinded; description of withdrawals and dropouts provided: no exclusions from the population were necessary Not Relevant Sample size calculation not defined; statistical methods unclear; no parental consent form; study not approved by a formal university institutional review board (approved by school board of education); limited SES diversity; soap and handwashing not monitored; clustering not accounted for
Morton 16 2004 United States Study was described as randomized however did not explain method of randomization; neither participants or study-coordinators were blinded; description of withdrawals and dropouts provided: of the 17 initial classes (285 students), 17 classes ((253 students, 120 girls and 133 boys), non-consent = 22 children, adverse-events = 10 children) Unclear Sample size calculation not defined; data not in a format which could be easily extracted; study approved by Board of Education, and the Institutional Review Board at the state's largest hospital; a consent form was sent to all parents and guardians; clustering not accounted for
Cluster NRCTs
Hammond 31 2000 United States Study was not formally randomized; neither participants or study-coordinators were blinded; description withdrawals and dropouts provided: 1 school district did not comply with protocol; 25/3080 students did not participate or complete the protocol (in each case, data was not used for results) Not Relevant Sample size calculation not defined; no parental consent form; formal review not mentioned; clustering not accounted for
Guinan 10 2002 United States Study was not formally randomized; participants and study-coordinators were not blinded; description withdrawals and dropouts not provided Not Relevant Sample size calculation not defined; statistical methods unclear; no parental consent form; formal review not mentioned (approved by each school); limited SES diversity (high SES); performed in peak absenteeism season; clustering not accounted for