How does the elicitation and exploration of parent treatment preferences effect the conduct of primary care trials with children: a secondary qualitative analysis of baseline visits within the Best Emollient for Eczema (BEE) trial.

Problem

Recruitment to randomised controlled trials (RCTs) should only occur when there is ‘equipoise’ – uncertainty over the most effective treatment – and when potential recruits have been given sufficient information to make an informed choice to consent to participation. The BEE trial a pragmatic, individually randomised trial evaluating the effectiveness of four types of emollient (lotion, cream, gel, ointment) for childhood eczema. Currently there is no evidence that one formulation is superior and there are wide variations in which emollient are recommended. The lack of clinical consensus adds to parental confusion and likely results in poor disease control. Parents of children recruited to BEE already have prior experiences of emollients but may not understand that equipoise exists around their relative effectiveness or acceptability and may have their own treatment preferences.

Approach

Overall objective: To explore the role of parent and children’s treatment preferences in a primary care trial of four different types of emollient for children with eczema. Aims: To use audio-recordings of baseline appointments from the BEE trial to: 1. Examine when and how parent preferences are elicited, expressed and responded to 2. Explore how the nature or timing of preference elicitation affects perceived understanding of participant in trial, willingness to give consent and subsequent actions3. Compare how different research nurses communicate clinical equipoise, random allocation to treatment arms and the importance of adherence to treatment. 4. Identify possible reasons for not adhering to allocated treatment or withdrawal from the trialA framework will be used to purposively sample participants across each of the three trial centres, including interviews from each research nurse at various points in the trial timeline, to reflect experience and trial staff turnover. Secondary criteria will also be considered including participant age, eczema severity and ethnicity. The interviews will be transcribed verbatim and analysed thematically, using an adapted framework approach. NVivo will be used to facilitate data management and coding.

Findings

Work in progress.

Consequences

To date, qualitative research within trials undertaken in primary care have not specifically focused on prior treatment preferences and how they influence recruitment, the consent process or engagement in the trial. Ultimately understanding how patient preferences impact trials is essential given that ultimately trials may observe a treatment effect, or absence thereof, as a result of patient preferences rather than as a therapeutic effect.