Valid to: 14/10/13. Superseded version number and date (if applicable): 1: 26 Nov 2009

Transcription

1 Document Number: SOP/23/V2 Title: Assessment of Atopic Dermatitis in children using SCORAD Author: Susan MacFarlane Version 2 Date created: 5 Jan 2010 Effective from: 14/10/10 Superseded version number and date (if applicable): 1: 26 Nov Purpose 1.1 This Standard Operating Procedure (SOP) describes the correct procedure for the assessment of Atopic Dermatitis (AD) in children and young people using the SCORAD scale. 1.2 SCORAD ("SCORing Atopic Dermatitis") is a clinical tool for assessing the severity (i.e. extent, intensity) of Atopic Dermatitis as objectively as possible (Appendix 1). 1.3 SCORAD is used in clinical trials to evaluate disease improvement during and after treatment. 1.4 The European Task Force on Atopic Dermatitis (ETFAD) developed SCORAD to create a consensus on assessment methods for AD, so that study results can be compared. 1.5 To measure the extent of AD, the Rule of Nines is applied on a front/back drawing of the child s inflammatory regions. The rule of nines is a method used when calculating body surface area, originally used for burns where values of 9 or 18% of surface area are assigned to specific regions (Appendix 2). This rule accounts for inequities in size, weight and shape to calculate a percentage of total body area. For partially affected areas the percentage is approximated. 1.6 The SCORAD identifies the intensity of six items: erythema, oedema/population, excoriations, lichenification, oozing/crusts and dryness. 1.7 The SCORAD identifies subjective items using visual analogue scales for daily pruritis and sleep disturbance. 2.0 Scope This SOP applies to the correct procedure to be followed by the Principal Investigator, medical staff and research staff when assessing a child or young person s skin for the severity and extent of Atopic Dermatitis as a component of a research study. Page 1 of 5

2 3.0 Responsibilities 3.1 Staff must ensure they have received the appropriate training on the SCORAD tool and be familiar with completion instructions and calculations. All items must be completed to ensure an accurate score. 3.2 SCORAD assessment will only be carried out to assess the skin of children with diagnosed Atopic Dermatitis. 3.3 Staff completing the SCORAD must have a basic knowledge of Atopic Dermatitis scope, severity, and treatment. 4.0 Procedures 4.1 Introduce self to parent and child 4.2 Ensure child and parent are in a quiet, private, warm area 4.3 Ensure consent from parent and assent from child remain valid. 4.4 Discuss with parent and child the process of using the SCORAD tool. 4.5 Ask parent to assist child to remove clothing (leaving only underwear) to allow close observation of all of the skin, including front and back aspects of body. 4.6 If the child is uncomfortable, expose only affected skin areas as tolerated. 4.7 Ensure research staff member is using an age appropriate SCORAD tool. 4.8 Wash hands prior to touching, with permission from the child and parent, the child s skin to assess dryness and lichenification. 4.9 Complete SCORAD tool using the Rule of Nines shading the affected areas on the SCORAD diagram to provide an interpretation of the percentage of affected area. If only partial area is affected, only partial score is recorded. For example, if the diagram shows optimum score for the frontal aspect of the whole leg is 9 and only the lower half of the child s leg is affected then the score would be interpreted as 4.5 (Appendix 1, section A) Record the severity of symptoms using the identified scales (Appendix 1, section B) Discuss with parent and child where appropriate sleep loss and presentation of itch using the analogue scales found on SCORAD tool section C (Appendix 1) Using the identified equation calculate the SCORAD score and record on tool in the appropriate section (Appendix 1). Page 2 of 5

3 Additionally record the SCORAD score in participant s medical notes and in Case Report Form. Recheck calculation to ensure accuracy (Appendix 1) If two professionals are using SCORAD tool, discuss the results and record in the appropriate documentation The professional completing the SCORAD tool must sign and date in the appropriate section for identification and accountability as good clinical practice (Appendix 1) Ask parent to replace child s clothing Inform parent and child of the result of the SCORAD assessment and discuss with them any improvement or deterioration in extent of Atopic Dermatitis If SCORAD assessment meets the study inclusion criteria and/or study visit criteria arrange future study visit within identified time frames If SCORAD assessment does not meet study inclusion criteria and/or study visit criteria and indicates withdrawal from the study discuss with parent and child procedure to be followed in accordance with study protocol. If SCORAD has been completed by one person only ask a suitably qualified colleague to complete an assessment for comparison. Inform Principal Investigator (PI) of SCORAD assessment and protocol requirements and where possible PI should attend to recheck assessment. If PI and study personnel determine SCORAD assessment does not meet the protocol criteria complete end of study visit/early termination visit as identified in protocol and ensure routine dermatological clinical care has been arranged. 5.0 Related Documents Rule of Nine (Appendix 1). SCORAD Tool (Appendix 2). Case Report Form Study Specific Training 6.0 References ICH/GCP Directive/guidelines EU Clinical Trials Directive ORANIE, A et al Practical Issues on interpretation of scoring Atopic Dermatitis: the SCORAD index, objective SCORAD and the three-item severity score. British Journal of Dermatology. 157(4): Online SCORAD Training Page 3 of 5

4 Approval: Name: Prof Peter Helms Position: Network Director Signature: Date: 14/10/10 APPENDIX 1 SCORAD Tool Page 4 of 5

5 APPENDIX 2 Rule of Nine for Children <2 years of age. Rule of Nine for Older Children and Adults Images reproduced for reference from; Page 5 of 5