title: Measurement properties of quality of life measurement instruments for infants, children and adolescents with eczema: protocol for a systematic review.
abstract: BACKGROUND
  Eczema is a common chronic or chronically relapsing, inflammatory skin disease that exerts a substantial negative impact on quality of life (QoL). The Harmonising Outcome Measures for Eczema (HOME) initiative has used a consensus-based process which identified QoL as one of the four core outcome domains to be assessed in all eczema clinical trials. A number of measurement instruments exist to measure QoL in infants, children, and adolescents with eczema, and there is a great variability in both content and quality of the instruments used. Therefore, the objective of the proposed research is to comprehensively and systematically assess the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in infants, children, and adolescents with eczema.
  
  
  METHODS
  This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for infants, children, and adolescents with eczema. A systematic literature search will be carried out in MEDLINE via PubMed and EMBASE using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for infants, children, and adolescents with eczema. Two reviewers will independently perform eligibility assessment and data abstraction. Evidence tables will be used to record study characteristics, instrument characteristics, measurement properties, and interpretability. The adequacy of the measurement properties will be assessed using predefined criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist will be used to evaluate the methodological quality of included studies. A best evidence synthesis will be undertaken if more than one study has examined a particular measurement property.
  
  
  CONCLUSIONS
  The proposed systematic review will yield a comprehensive assessment of measurement properties of existing QoL instruments in infants, children, and adolescents with eczema. The results will serve as a basis to recommend a QoL measurement instrument for infants, one for children, and one for adolescents for use in future clinical trials.
  
  
  BACKGROUND
  PROSPERO CRD42015023483.
authors: Medical Sociology, Department of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany. daniel.heinl@stud.uni-regensburg.de.
authors: Daniel
authors: D
authors: Heinl
authors: Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands. c.prinsen@vumc.nl.
authors: Cecilia A C
authors: CA
authors: Prinsen
authors: Department of Dermatology, The Warren Alpert Medical School of Brown University, Providence, RI, USA. amdrucker@gmail.com.
authors: Aaron M
authors: AM
authors: Drucker
authors: Department of Clinical Social Medicine, University Hospital Heidelberg, Heidelberg, Germany. Robert.Ofenloch@med.uni-heidelberg.de.
authors: Robert
authors: R
authors: Ofenloch
authors: , Budleigh Salterton, Devon, UK. RNHumphreys@aol.com.
authors: Rosemary
authors: R
authors: Humphreys
authors: Norwich Medical School, University of East Anglia, Norwich, UK. t.sach@uea.ac.uk.
authors: Tracey
authors: T
authors: Sach
authors: St John's Institute of Dermatology, King's College London, London, UK. carsten.flohr@kcl.ac.uk.
authors: Carsten
authors: C
authors: Flohr
authors: Medical Sociology, Department of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany. christian.apfelbacher@klinik.uni-regensburg.de.|Division of Public Health and Primary Care, Brighton and Sussex Medical School, Falmer, UK. christian.apfelbacher@klinik.uni-regensburg.de.
authors: Christian
authors: C
authors: Apfelbacher
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic; D004485:Eczema; D006304:Health Status; D006801:Humans; D007223:Infant; D017063:Outcome Assessment, Health Care; D019727:Proxy; D011788:Quality of Life; D015203:Reproducibility of Results; D057566:Self Report; D011795:Surveys and Questionnaires; D000078202:Systematic Reviews as Topic