title: The effect of patients' preference on outcome in the EVerT cryotherapy versus salicylic acid for the treatment of plantar warts (verruca) trial.
abstract: BACKGROUND
  Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias. One such bias is the effect of patient's preference on outcome measures. The aims of this study were to examine whether patients' treatment preference affected clearance of plantar warts and explore whether there were any associations between patients' treatment preference and baseline variables in the EverT trial.
  
  
  METHODS
  Two hundred and forty patients were recruited from University podiatry schools, NHS podiatry clinics and primary care. Patients were aged 12 years and over and had at least one plantar wart which was suitable for treatment with salicylic acid and cryotherapy. Patients were asked their treatment preference prior to randomisation. The Kruskal-Wallis test was performed to test the association between preference group and continuous baseline variables. The Fisher's exact test was performed to test the association between preference group and categorical baseline variables. A logistic regression analysis was undertaken with verruca clearance (yes or no) as the dependent variable and treatment, age, type of verruca, previous treatment, treatment preference as independent variables. Two analyses were undertaken, one using the health professional reported outcome and one using the patient's self reported outcomes. Data on whether the patient found it necessary to stop the treatment to which they had been allocated and whether they started another treatment were summarised by treatment group.
  
  
  RESULTS
  Pre-randomisation preferences were: 10% for salicylic acid; 42% for cryotherapy and 48% no treatment preference. There was no evidence of an association between treatment preference group and either patient (p=0.95) or healthcare professional (p=0.46) reported verruca clearance rates. There was no evidence of an association between preference group and any of the baseline variables except gender, with more females expressing a preference for salicylic acid (p=0.004). There was no evidence that the number of times salicylic acid was applied was different between the preference groups at one week (p=0.89) or at three weeks (p=0.24). Similarly, for the number of clinic visits for cryotherapy (p=0.71) CONCLUSIONS: This secondary analysis showed no evidence to suggest that patients' baseline preferences affected verruca clearance rates or adherence with the treatment.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN18994246 and National Research Register N0484189151.
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK. Kim.Thomas@nottingham.ac.uk.
authors.forename: Sarah
authors.initials: S
authors.lastname: Cockayne
authors.forename: Kate
authors.initials: K
authors.lastname: Hicks
authors.forename: Arthur R
authors.initials: AR
authors.lastname: Kangombe
authors.forename: Catherine
authors.initials: C
authors.lastname: Hewitt
authors.forename: Michael
authors.initials: M
authors.lastname: Concannon
authors.forename: Kim
authors.initials: K
authors.lastname: Thomas
authors.forename: Farina
authors.initials: F
authors.lastname: Hashmi
authors.forename: Caroline
authors.initials: C
authors.lastname: McIntosh
authors.forename: Gwen
authors.initials: G
authors.lastname: Brierley
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
authors.forename: Ian
authors.initials: I
authors.lastname: Watt