Abstract
BackgroundRandomised 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.MethodsTwo 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.ResultsPre-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)ConclusionsThis secondary analysis showed no evidence to suggest that patients’ baseline preferences affected verruca clearance rates or adherence with the treatment.Trial registrationCurrent Controlled Trials ISRCTN18994246 and National Research Register N0484189151
Highlights
Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias
One hundred and seventeen patients were allocated to the cryotherapy group and 123 to the salicylic acid group
One hundred and fourteen (47.5%) patients expressed a treatment preference at baseline; of those 114 patients, twenty-eight (12.8%) expressed a preference for salicylic acid and 86 (39.5%) patients expressed a preference for cryotherapy
Summary
Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias. The external validity of a trial may be affected if large numbers of patients, who have a strong preference for a particular treatment, refuse to take part in the study as they are not guaranteed to receive their treatment of choice [5]. In this case, the generalisabilty of the study’s findings may be limited. The internal validity of a study can be affected depending on whether or not patients who agree to be randomised receive their preferred treatment Patients who receive their preferred treatment may be more motivated and comply better with the treatment and report better outcomes compared to those who do not receive their preferred treatment. Those patients who do not receive their preferred treatment may experience resentful demoralisation and may be more likely to drop out of the study, resulting in differential loss to follow-up [6]
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