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Table 1 Timetable of study assessments

From: A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

  RCT Observational period
Outcomes collected 0 months 2 months 4 months 6 months 8 months
Informed consent for main study     
Informed consent for genetic study (optional)     
Eligibility checks     
Eczema severity (NESS)     
Supply garments √ intervention    √ control  
Demographics     
Collect saliva sample (optional)     
Issue diary  
EASI and TIS  
Investigator and Patient Global Assessment (IGA and PGA)  
Topical treatment usage   
Medication for skin infection  
Use of wet and dry wraps  
On-line questionnaire (weekly) including POEM, topical treatment use and use of wet and dry wraps   
Final on-line questionnaire     
DFI    
EQ-5D-3 L of parent    
Child utility scales (ADQoL, CHU-9D)    
Number of infections  
Serious adverse events   
NHS and family resource use √ & Diary √ & Diary √ & Diary
Adherence   Ques Ques Ques Ques
Durability of clothing    
Acceptability (parent and child)    
Replace garments if required (intervention group only)    
  1. CHU-9D – The Child Health Utility, nine dimensions, DFI Dermatitis Family Impact questionnaire, EASI Eczema Area and Severity Index, EQ-5D-3 L – EuroQol Five Dimension, Three Levels questionnaire, NESS Nottingham Eczema Severity Scale, POEM Patient Oriented Eczema Measure, Ques = weekly on-line/postal questionnaire, TIS Three Item Severity scale