Assessing the effect of clinical trial evidence and anecdote on caregivers' willingness to use corticosteroids: a randomized controlled trial: a critical appraisal.

AIM

Johnson et al. aimed to assess caregivers' willingness to treat childhood atopic dermatitis (AD) with a corticosteroid when presented with clinical trial evidence, anecdote, or both.

SETTING AND DESIGN

This prospective parallel group (1: 1; eight groups) randomized control trial (RCT) was carried out with caregivers recruited from a tertiary care dermatology clinic in the USA and an online crowdsourcing platform using caregivers who may not have had a child with AD.

STUDY EXPOSURE

Caregivers were randomized to eight groups. The three main groups were given clinical trial evidence, anecdote, or a combination of both. Each of these three groups was further divided and presented with either the term 'medication' or 'topical steroid'. These were compared with the two remaining groups, which included a group told that they would not be informed of a medication's efficacy or safety profile, and a group informed that the medication was recommended by the doctor.

OUTCOME

Caregivers were asked about their willingness to treat based on the information they had received using a 10-point Likert scale where 1 was 'not willing' and 10 'completely willing'.

RESULTS

A total of 476 caregivers were recruited (80 clinic, 396 online), 48% of whom had a history of a child with AD. Caregivers' willingness to treat was higher in all information assignment groups compared with those not provided with safety information: clinical trial evidence of a 'medication' (P = 0·003; Cohen's d = 0·83) or 'topical steroid' (P = 0·030; d = 0·55), anecdote of a 'medication' (P < 0·0001; d = 1·37) or 'topical steroid' (P < 0·0001; d = 0·85), both clinical trial evidence and anecdote of a 'medication' (P < 0·0001; d = 1·00) or 'topical steroid' (P = 0·000; d = 0·89), and simply the doctor's recommendation (P < 0·0001; d = 0·92).

CONCLUSION

Johnson et al. conclude that the provision of anecdotal reassurance may be an effective strategy to improve caregivers' willingness to use topical steroids.

COMMENT

Exploring factors that affect caregivers' willingness to adhere to topical corticosteroids is an important area of research. This study was a potentially efficient way of conducting a rapid RCT to explore such factors. The study conclusions are significantly undermined by lack of a registered trial protocol, poor trial reporting, the use of caregivers who did not have experience of AD, the multiplicity and complexity of treatment arms, and the use of an unvalidated primary outcome.