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. 2012 Sep 12;2012(9):CD001781. doi: 10.1002/14651858.CD001781.pub3

Focht 2002.

Study characteristics
Methods This study was carried out in a secondary care setting.
This study was blinded.
Intention‐to‐treat analysis was not carried out.
This study was conducted in the USA.
Participants 61 participants were recruited: 10 dropped out.
Inclusion criteria of the trial
  • Adults and children

  • Ordinary warts

  • Warts on the hands or feet

Interventions
  • Duct tape occlusion for 6 days then replaced with new tape for up to 2 months versus

  • 2‐ to 3‐weekly cryotherapy (maximum of 6 sessions)

Outcomes Outcomes of the trial
  1. Cure at 2 months

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was computer‐generated.
Quote (page 972): "Patients were then randomised, using a computer‐generated code, to 1 of 2 treatment arms: cryotherapy or duct tape."
Comment: This was adequate.
Allocation concealment (selection bias) Unclear risk No method of allocation concealment was described. However, nurses had access to the data sheet (which may be the allocation sequence), which suggests it was not adequately concealed. (page 972)
Blinding of participants and personnel (performance bias)
All outcomes High risk It is unclear if participants were blinded, but because of the nature of the intervention, this was unlikely. 
Quote (page 972): "Study physicians and nursing personnel were blinded to the therapy being used." "Patients in the duct tape arm were instructed to remove all tape prior to making a return clinic visit. This was effective in keeping nursing personnel blinded to which treatment arm a patient was in until after they measured the study wart. Nursing personnel then checked the data sheet to see which arm the patient was in for further therapy."
Comment: Although some attempt at blinding was made, the nursing personnel had knowledge of the treatment group. Therefore, blinding was probably not adequate.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome assessors were blinded.
Quote (page 972): "Study physicians and nursing personnel were blinded to the therapy being used. Patients in the duct tape arm were instructed to remove all tape prior to making a return clinic visit. This was effective in keeping nursing personnel blinded to which treatment arm a patient was in until after they measured the study wart."
Comment: There were multiple follow‐up visits, so it was possible that nursing personnel knew which treatment arm a participant was in.
Incomplete outcome data (attrition bias)
All outcomes High risk 10/61 participants were not available for follow up, and they were not included in the investigators' analyses: 3 from the duct tape group and 6 from the cryotherapy group; no reasons were given. 1 wart was lost in an accident. There was discrepancy between the 2 groups.
Quote (page 973): "...had to rely on parental report of resolution over the telephone."
Comment: This may have introduced detection bias by relying on parent reports (parent not blinded), and parents may not have had the incentive to return for a follow‐up appointment.
Selective reporting (reporting bias) High risk The outcomes included complete resolution of the study wart and time to resolution of the warts.
Time to resolution of the wart was not accurately recorded because of variability in when the contact or follow‐up appointments were made. (see page 974)