Consent forms and study questionnaires case report forms will be stored securely and made accessible only to the research team and authorized personnel. Data from case report forms completed on paper by the participant or research team are entered in a study database, which incorporates data validation rules to reduce data entry errors, and management functions to facilitate auditing and data quality assurance.
At the end of the trial, the database will be cleaned and locked. Patient identifiers will be kept in a separate system from the clinical data. The database and randomization system will be designed to protect patient information, in line with the UK Data Protection Act Participants will be identified only by a patient ID number on the case report form.
Participant recruitment and follow-up via each of the two recruitment pathways will be reported using a CONSORT flowchart showing the numbers of people approached, eligible, recruited and randomized with reasons for exclusions. The proportion of children approached who were randomized to a study emollient and used it for the duration of the study the primary outcome measure will be reported.
We will explore how participant recruitment and retention varies by recruitment pathway and practice and participant characteristics. We will report data completeness of daily, weekly and monthly measures, recorded by parents and collected by the research team. In respect of the diary, we will compare data completeness between paper, with or without text reminders, and app versions. The different outcome measures will be presented as summary statistics, to allow sensitivity of each measure to change over time to be compared. The different emollients will be compared in terms of these summary outcome measures, and in terms of parent-completed questionnaires, to identify any early evidence of the inferiority of a particular emollient, which would inform the choice of emollients to be included in the main trial.
Feedback from parents of participants regarding satisfaction with the allocated emollient and trial processes, procedures and paperwork will be presented. Bang blinding index data will be presented to evaluate the success of keeping researchers masked to treatment allocation. We will test the feasibility of using data collected during the trial to carry out a cost-effectiveness study from the perspectives of the NHS, parents, and the value of lost productivity. Data on resource use collected via the patient diary will be used to identify the level of missingness, by item, and which items are important cost drivers.
This information will be used in designing data collection for the economic evaluation in the full trial. NICE recommends the use of quality-adjusted life years as the preferred outcome measure in economic evaluations. However, no validated generic measure of health-related quality of life is psychometrically and conceptually robust enough for young children under the age of 3. We are therefore using a preference-based measure of health in children with atopic dermatitis [ 18 ] in this feasibility study, which will indicate the value of using it to estimate quality-adjusted life years in the full trial.
Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made.
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We will aim for a target sample size of , 40 in each arm. This is sufficiently precise to inform the design of a definitive trial. The University of Bristol will act as sponsor for the trial reference UoB No formal interim statistical analyses are planned: it is expected that the study recruitment will terminate when the intended sample size have been achieved. The committee will be masked to the identity of the treatment arms unless unexpected numbers of adverse events warrant examination of data by treatment allocation.
Expected non-serious for example, upper respiratory tract viral infections, diarrhoea or vomiting and serious for example, lower respiratory tract infections or urinary tract infections adverse events that cannot be causally related to study participation will not be reported. Expected serious adverse events that might be related to study participation will be reported to the sponsor within 24 hours of knowledge of the event.
All relevant information about a suspected unexpected serious adverse reaction will be reported within 7 days to the Medicines and Healthcare Products Regulatory Agency MHRA and the ethics committee. The chief investigator and study sites will allow monitors, persons responsible for the audit, representatives of the ethics committee and of the regulatory authorities to have direct access to source data and documents.
The current protocol version is 1. Version 1. All amendments have been approved by the relevant regulatory bodies and communicated to relevant parties. Following a separate agreed publication policy, we will disseminate findings through local and national networks, including key professional, public stakeholder and educational organizations. Dissemination will also occur via oral presentations and posters to national primary care and dermatological scientific conferences, and by publication in peer-reviewed journals. For promotional and informative purposes, the study website [ 23 ] and on-line social media Twitter [ 24 ] and Facebook [ 25 ] are publically accessible.
A summary of the main findings will be distributed via these routes at the end of the study and specifically for the participants involved. In addition to establishing the feasibility of the definitive study, we are collecting data around the acceptability and effectiveness of four commonly used emollients, which may guide the choice of emollients in any future study.
During the first 7 months of recruitment, children had to be between 1 month and 3 years of age and have their eczema diagnosis confirmed by a doctor. Since the study was originally proposed, the HOME initiative has published welcome guidance on which measures of clinical signs should be included as a core outcome in clinical trials of patients with eczema Eczema Area Severity Index [ 26 ]. When the study was designed, there was uncertainty about which of the more commonly used means of assessing eczema severity should be used, hence the inclusion of three Eczema Area Severity Index, Six Area, Six Sign Atopic Dermatitis severity score, Three Item Severity score outcomes.
Despite this being a feasibility study of four of the emollients most commonly prescribed in the UK, which are also available to buy over the counter, COMET has been classed as a controlled trial of an investigational medicinal product in children. The associated regulation and accompanying paperwork and approval required have increased the set-up time and made study management more complex. All participants are allocated an emollient that is, there is no control group because we believed that clinicians and parents would be reluctant to take part in a study where they might not be prescribed anything specifically to moisturize the skin; and because it would probably be deemed unethical to do so.
It is possible that, depending on the acceptability and preliminary effectiveness findings, the number of emollients in the main trial could be reduced. It is not possible to mask carers and clinicians because the study emollients are very different in their consistency and smell, and because we are asking GP surgeries to prescribe the treatment.
At the end of the study, we will have established the feasibility of the main trial and produced valuable preliminary data on emollient acceptability and effectiveness. As a consequence the treatment of children with eczema should be improved and costs to the NHS and patients reduced through fewer consultations and more efficient prescribing. Williams HC. Atopic dermatitis: the epidemiology, causes and prevention of atopic eczema.
Cambridge: Cambridge University Press; Quality of life and disease severity are correlated in children with atopic dermatitis. Br J Dermatol.
Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. What is the cost of atopic dermatitis in preschool children? Severity distribution of atopic dermatitis in the community and its relationship to secondary referral.
The Eczema Society of Canada
Dermatology Nursing ; Supplement. Use of an emollient as a steroid-sparing agent in the treatment of mild to moderate atopic dermatitis in children. Pediatr Dermatol. Lawton S. Practical issues for emollient therapy in dry and itchy skin. Br J Nurs. Systematic review of treatments for eczema. Health Technol Assess. Atopic eczema in children: management of atopic eczema in children from birth up to the age of 12 years.
Global Resource for Eczema Trials. The use of alternative medicine in pediatric patients with atopic dermatitis. The Eczema Priority Setting Partnership: a collaboration between patients, carers, clinicians and researchers to identify and prioritize important research questions for the treatment of eczema. Paediatric formulary committee. BNF for Children — London: Pharmaceutical Press; Assessment of blinding in clinical trials. Control Clin Trials.
Arch Dermatol. The Dermatitis Family Impact questionnaire: a review of its measurement properties and clinical application. The development of a preference-based measure of health in children with atopic dermatitis. J Eur Acad Dermatol Venereol. Berth-Jones J. Six Area, Six Sign Atopic Dermatitis severity score: a simple system for monitoring disease activity in atopic dermatitis.
Scoring the severity of atopic dermatitis: three item severity score as a rough system for daily practice and as a pre-screening tool for studies. Acta Derm Venereol. EEMCO guidance for the assessment of stratum corneum hydration: electrical methods. Skin Res Technol. COMET study. J Allergy Clin Immunol. Download references. Whitman bristol. The views expressed in the publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.
Correspondence to Matthew J Ridd. She has previously received payment from Leo Pharma in the past for education sessions. None of the other authors has any competing interests. MR proposed the original study idea and its design. A great shave at a fair price. Oral-B Genius X electric toothbrushes Shop now.
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