Synopsis

Research summary

Eczema is very common and can cause substantial impact on quality of life for many reasons including sleep disturbance and itch.1,2 Families of children with eczema express frustration that they receive insufficient or conflicting information about how to manage the condition,3 as do adults with eczema.4 People with eczema have highlighted the need for tailored information that explains underlying principles in order to motivate treatment adherence.5,6 Reasons for non-adherence include:2

• Therapy being time-intensive.7,8
• Poor understanding of treatments and how to use them.7
• Underuse of topical corticosteroids (TCSs) related to fear of side effects.9
• Conflicting advice from different health professionals regarding how to use TCSs.10
• Child refusal.8

Self-care includes all the health behaviours that people take to look after their condition, including treatment adherence. Non-adherence is related to people’s understanding of their condition and its treatment, as well as perceived need for treatments and concerns about adverse consequences of treatments.11 Self-care is particularly complex in eczema as it involves regular application of topical treatments (mainly emollients for maintenance and TCSs for inflamed eczema) and avoidance of triggers (e.g. dust). Presently, many people with eczema or their parents/carers receive little advice on how to manage their condition or obtain advice of variable quality from the internet.12 There is a need for high-quality interventions accessible for all, as well as evidence of whether they work so that clinicians can signpost towards these as an essential part of routine care.2

Importance and relevance of the Eczema Care Online programme

Childhood eczema is very common, affecting over 20% of children aged 5 or less13,14 and 10% of adults.15 Research among children with eczema in secondary care suggests that the impact on quality of life from severe eczema is second only to cerebral palsy, with greater impact than for asthma or diabetes16 and adults with eczema can also suffer severe impact.17 Although the majority of eczema is ‘mild’, this can still cause substantial impact on quality of life.18 Although there is a common perception that eczema mainly affects young children, approximately 40% continue to experience symptoms into adulthood. Teenagers and adults often experience more severe disease and a substantial impact on quality of life, healthcare costs and work/school absence.19

Qualitative research has illustrated the impact on both children and adults:

She hardly got any sleep, she scratched herself, and she was at a point where she couldn’t keep up at school, she was totally exhausted.3

For some families of children with eczema, regularly applying topical treatments can become distressing:

She’s kicking and going and screaming, people must think that we are really sort of hurting her …10

Eczema has considerable socioeconomic impact,20 and, on the basis of trial data (Softened Water Eczema Trial21 and CLOTHES22), we estimate the current annual cost of eczema to the NHS to be between £3.48B and £4.43B. Previous research has demonstrated the potential value of education-based interventions for eczema. One trial has demonstrated improved eczema outcomes following 12-hour group training for eczema,23 but international data suggest that availability of eczema education is limited in most countries.24

This programme of work addressed priority areas for eczema research as identified by a James Lind Alliance Eczema Priority Setting Partnership:25

• What is the best way of delivering eczema care and support?
• What is the long-term safety of TCSs?

These priorities are linked, as uncertainty about TCS safety appears to lead to inconsistent advice from health professionals and is a barrier to self-care among people with eczema or their parents/carers.

Original aims and objectives

The programme of work set out to improve the lives of people with eczema by developing and testing online behavioural interventions (websites) that will support self-care and address common barriers to eczema self-care, including concerns around TCSs.

The objectives of the programme are shown in Figure 1. These are:

1. To understand facilitators and barriers to effective eczema management for patients and parents/carers.
2. To update and combine existing evidence around the safety of TCSs and develop knowledge tools for patients and healthcare professionals.
3. to Develop online behavioural interventions to support eczema self-care for patients and parents/carers (informed by findings from workstreams 1 and 2).
4. To determine the clinical and cost-effectiveness of online behavioural self-care interventions compared to standard clinical care.
5. To formulate and initiate an implementation plan for integrating interventions into clinical practice and facilitating their uptake (if clinically and cost-effective), informed by process evaluation.

FIGURE 1 Overview of ECO workstreams. (Figure not reproduced here; see the original article.)

Modifications to original aims

Changes to workstream 2

We originally planned to conduct two systematic reviews on the safety of TCSs: one of randomised controlled trial (RCT) data and one of observational study data. Feedback from patients and carers challenged that it is not sufficient to look at the safety of TCSs in isolation, as safety is closely linked to the concept of ‘appropriate use’ of TCSs. In response, we enlarged the scope of our planned review of RCTs to include effectiveness outcomes as well as safety outcomes, and to explicitly examine different strategies for using TCSs (e.g. once daily vs. twice daily, reactive vs. proactive therapy). We delivered three systematic reviews as part of workstream 2:

1. Umbrella review of published systematic reviews on the safety of TCSs in eczema.
2. Cochrane systematic review of the best and safest ways of using TCSs in eczema (RCT evidence only).
3. Systematic review of the longer-term safety of TCSs (RCT and observational studies with more than 1 year of follow-up).

Changes to workstream 4

Minor modifications were made to the designs of the two RCTs to improve their efficiency and in response to the COVID-19 pandemic. We originally planned to conduct two feasibility RCTs, but through our robust intervention development work, and iterative feedback from users, we were able to establish that changes to the intervention would be very unlikely between feasibility and main trial and we decided to change the feasibility trials to internal pilot trials, retaining the stop/go criteria originally planned before commencing the main trials. This enabled the pilot trial data to be used in the main trials, increasing programme efficiency. We also changed our recruitment strategy to recruit through primary care only, rather than primary and secondary care as originally planned. This was partly in response to our experience in workstream 1 where we encountered challenges with secondary care recruitment, but we also found that we were recruiting sufficient numbers of people with moderate to severe eczema through primary care. Recruiting through primary care only for the RCTs enabled us to conduct medical notes review for all participants, which was important for collection of secondary outcomes.

Changes were made to the secondary outcome measures of the RCTs following the final meeting of the Harmonising Outcome Measures for Eczema initiative (www.homeforeczema.org) in 2019. The finalised Core Outcome Set includes long-term control measured by recap for atopic eczema patients (RECAP) and itch intensity single item for adults. These were added and did not substantially add to questionnaire burden. Following discussion with our independent programme steering group and funder, we decided not to include Eczema Area and Severity Index (EASI) as a secondary outcome, which was originally included only at follow-up so as not to ‘dilute’ the online-only intervention at baseline. EASI is not recommended to be used at follow-up only. Excluding EASI as an outcome measure meant the trial could be delivered fully online and therefore in more geographical regions which boosted the diversity of our study population and reduced our carbon footprint as people did not have to travel for in-person assessment.

Further changes were made to the RCT design in response to the COVID-19 pandemic. We made minor changes to ensure all trial processes were online. We also increased the trial sample size from 200 to 303 participants per trial to detect a smaller minimal clinically important difference (MCID) in our primary outcome patient-oriented eczema measure (POEM) of 2.5 instead of 3 as new evidence emerged suggesting this is meaningful in certain contexts. Finally, we published an additional qualitative study of the impact the pandemic had on people’s management of eczema which emerged from our process evaluation interviews.

Changes to workstream 5

Changes to the trial design and successful recruitment through primary care meant that the programme had a significant underspend and was ahead of schedule. Following discussion with the programme management group, the independent programme steering group and funder, we were given permission to repurpose funds to redevelop the trial version of the interventions into a marketable product in English and Welsh ready for dissemination. This product is freely available at www.eczemacareonline.org.uk.

Patients and public involvement throughout the programme

Patient and public involvement (PPI) co-applicants Amanda Roberts and Amina Ahmed have been actively involved in all aspects of programme planning, project management, intervention development, systematic reviewing, protocol development, trial management and implementation work. Wider patient and public engagement were gained through stakeholder workshops and work with the Centre of Evidence Based dermatology patient panel. Eczema Outreach Support (EOS) and the National Eczema Society (NES) worked closely with the Eczema Care Online (ECO) team throughout this programme. EOS and NES representatives were members of our Programme Steering Committee and attended various ECO stakeholder events. More detail on the PPI approach can be found in Patient, public and practitioner involvement in the programme.

Programme achievements

The ECO programme has achieved its intended objectives to develop and evaluate two interventions to support young people and families with eczema (workstreams 3 and 4). In addition, we have improved understanding of the experiences, barriers and facilitators of eczema management in children, young people and parents/carers (workstreams 1 and 5), and an understanding of how the intervention could be implemented in practice (workstream 5). We have also produced a comprehensive synthesis of the evidence on the safety and effectiveness of TCSs for eczema (workstream 2).

The work has been disseminated via academic, professional and public involvement routes, including publication in academic journals, presentations and public engagement events. Highlights include:

• Twenty-three peer-reviewed journal publications.
• Lay summaries and/or blogs to accompany publications.
• Twenty peer-reviewed conference presentations.
• Eight stakeholder engagement workshops.
• Two effective and cost-effective interventions to support management among people and families with eczema ready for implementation.