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The effect of patients’ preference on outcome in the EVerT cryotherapy versus salicylic acid for the treatment of plantar warts (verruca) trial

Sarah Cockayne1, Kate Hicks1, Arthur R Kangombe1, Catherine Hewitt1, Michael Concannon2, Kim Thomas3*, Farina Hashmi4, Caroline McIntosh5, Gwen Brierley1, David Torgerson1, Ian Watt16 and On behalf of the EVerT team

Author Affiliations

1 Department of Health Sciences, York Trials Unit, University of York, York, UK

2 Division of Podiatry, University of Huddersfield, The School of Human & Health Sciences, Huddersfield, UK

3 Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK

4 University of Brighton, School of Health Professions, Brighton, UK

5 The National University of Ireland, Galway, Discipline of Podiatry, Galway, Ireland

6 Department of Health Sciences, Hull York Medical School, University of York, York, UK

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Journal of Foot and Ankle Research 2012, 5:28  doi:10.1186/1757-1146-5-28

Published: 12 November 2012

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.

Trial registration

Current Controlled Trials ISRCTN18994246 and National Research Register N0484189151

Keywords:
Randomised controlled trial; Patients’ preference; Plantar warts; Verrucae