Test-guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST).

BACKGROUND: Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain. OBJECTIVE: To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible. METHODS: Children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185. RESULTS: From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4-6 weeks) - with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%-100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission. CONCLUSIONS: It is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds.

Engaging with diverse audiences to raise awareness about childhood eczema: reflections from two community events.

BACKGROUND: Eczema is a common childhood condition, causing dry and itchy skin which can be difficult to manage. We have been undertaking eczema and food allergy research to address previously prioritised research questions. We obtained funding to trial novel approaches to reach diverse audiences to raise awareness of childhood eczema, research, and public involvement in research. METHODS: This paper reflects on two public engagement events held in collaboration with stakeholders in two settings of ethnic diversity in East Bristol, UK. We invited parents and children to attend the events by public display of posters. We created novel activities related to the research and involved artists to engage parents/carers and children about eczema and the research we are doing into its management. RESULTS: Attendance at the first event was lower than expected. Lessons learned were incorporated into the second event, to use a more structured approach and attract greater numbers of parents/carers from more diverse backgrounds. Creative approaches such as using artists at both events made the subject more accessible for diverse audiences, including children. CONCLUSION: We successfully delivered two public engagement events. The success of the events has generated individual interest in PPI and enquiries about future events from neighbouring community groups. Reflections from the events have also been fed back to inform the research.

Parents and GPs' understandings and beliefs about food allergy testing in children with eczema: qualitative interview study within the Trial of Eczema allergy Screening Tests (TEST) feasibility trial.

AIM: To explore parent and general practitioner (GP) understanding and beliefs about food allergy testing for children with eczema. DESIGN AND SETTING: Qualitative interview study in UK primary care within the Trial of Eczema allergy Screening Tests feasibility trial. PARTICIPANTS: Semi-structured interviews with parents of children with eczema taking part in the feasibility study and GPs at practices hosting the study. RESULTS: 21 parents and 11 GPs were interviewed. Parents discussed a range of potential causes for eczema, including a role for food allergy. They believed allergy testing to be beneficial as it could potentially identify a cure or help reduce symptoms and they found negative tests reassuring, suggesting to them that no dietary changes were needed. GPs reported limited experience and uncertainty regarding food allergy in children with eczema. While some GPs believed referral for allergy testing could be appropriate, most were unclear about its utility. They thought it should be reserved for children with severe eczema or complex problems but wanted more information to advise parents and help guide decision making. CONCLUSIONS: Parents' motivations for allergy testing are driven by the desire to improve their child's condition and exclude food allergy as a possible cause of symptoms. GPs are uncertain about the role of allergy testing and want more information about its usefulness to support parents and help inform decision making. TRIAL REGISTRATION NUMBER: ISRCTN15397185.

Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough.

OBJECTIVE: To investigate recruitment and retention, data collection methods and the acceptability of a 'within-consultation' complex intervention designed to reduce antibiotic prescribing. DESIGN: Primary care feasibility cluster randomised controlled trial. SETTING: 32 general practices in South West England recruiting children from October 2014 to April 2015. PARTICIPANTS: Children (aged 3 months to <12 years) with acute cough and respiratory tract infection (RTI). INTERVENTION: A web-based clinician-focussed clinical rule to predict risk of future hospitalisation and a printed leaflet with individualised child health information for carers, safety-netting advice and a treatment decision record. CONTROLS: Usual practice, with clinicians recording data on symptoms, signs and treatment decisions. RESULTS: Of 542 children invited, 501 (92.4%) consented to participate, a month ahead of schedule. Antibiotic prescribing data were collected for all children, follow-up data for 495 (98.8%) and the National Health Service resource use data for 494 (98.6%). The overall antibiotic prescribing rates for children's RTIs were 25% and 15.8% (p=0.018) in intervention and control groups, respectively. We found evidence of postrandomisation differential recruitment: the number of children recruited to the intervention arm was higher (292 vs 209); over half were recruited by prescribing nurses compared with less than a third in the control arm; children in the intervention arm were younger (median age 2 vs 3 years controls, p=0.03) and appeared to be more unwell than those in the control arm with higher respiratory rates (p<0.0001), wheeze prevalence (p=0.007) and global illness severity scores assessed by carers (p=0.045) and clinicians (p=0.01). Interviews with clinicians confirmed preferential recruitment of less unwell children to the trial, more so in the control arm. CONCLUSION: Differential recruitment may explain the paradoxical antibiotic prescribing rates. Future cluster level studies should consider designs which remove the need for individual consent postrandomisation and embed the intervention within electronic primary care records. TRIAL REGISTRATION NUMBER: ISRCTN 23547970 UKCRN STUDY ID: 16891.