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Interpreting Negative Results From an Underpowered Clinical TrialWarts and All
Jeanne Van Cleave, MD;
Alex R. Kemper, MD, MPH, MS;
Matthew M. Davis, MD, MAPP
Arch Pediatr Adolesc Med. 2006;160(11):1126-1129.
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In the randomized, placebo-controlled trial by de Haen et al1 that appears in this issue of the ARCHIVES, the application of duct tape is compared with placebo as a treatment for common warts. The investigators recruited 103 children in the Netherlands from primary schools and assessed them for warts. Those with warts were randomized to 1 of 2 groups. One group received duct tape to apply to a designated wart, and the other group received a placebo in the form of a corn pad to apply around the wart. The primary outcome of the study was resolution of the designated wart 6 weeks after initiation of therapy. Other outcomes included change in the size of the designated wart and resolution of surrounding warts. Differences in complete resolution of the designated wart were not . . . [Full Text of this Article]WERE THE STUDY PATIENTS SIMILAR TO ACTUAL PATIENTS?
WERE PATIENTS RANDOMIZED? WERE THE PATIENTS IN THE TREATMENT AND CONTROL GROUPS SIMILAR WITH RESPECT TO KNOWN PROGNOSTIC FACTORS?
WERE PATIENTS AWARE OF GROUP ALLOCATION? WAS THE OBSERVER AWARE OF GROUP ALLOCATION?
WAS FOLLOW-UP COMPLETE? WERE PATIENTS ANALYZED IN THE GROUPS TO WHICH THEY WERE RANDOMIZED?
STATISTICAL POWER AND TYPE II ERROR
HOW PRECISE WAS THE ESTIMATE OF THE TREATMENT EFFECT?
WERE ALL CLINICALLY IMPORTANT OUTCOMES CONSIDERED?
CONCLUSIONS
AUTHOR INFORMATION
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RELATED ARTICLE
Efficacy of Duct Tape vs Placebo in the Treatment of Verruca Vulgaris (Warts) in Primary School Children
Marloes de Haen, Marcus G. Spigt, Caro J. T. van Uden, Pierre van Neer, Frans J. M. Feron, and André Knottnerus
Arch Pediatr Adolesc Med. 2006;160(11):1121-1125.
ABSTRACT
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Studies Should Report Estimates of Treatment Effects With Confidence Intervals
Cummings
Arch Pediatr Adolesc Med 2007;161:518-519.
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