title: Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial.
abstract: BACKGROUND
  VEINES-QOL/Sym is a disease-specific quality of life instrument for use in venous diseases of the leg. Its relative scoring system precludes comparisons between studies. There were very few venous leg ulcer patients in the validation samples. We report a validation study for venous leg ulcers and develop a scoring system which enables comparison between studies.
  
  
  METHODS
  Four hundred fifty-one participants in the VenUS IV trial of the management of venous leg ulcers were asked to complete a VEINES-QOL questionnaire at recruitment, along with SF-12, pain, and other aspects of quality of life. VEINES-QOL was repeated after two weeks and after 4 months. Healing of ulcers was confirmed by blind assessment of digital photographs. Three scoring systems for VEINES-QOL were compared.
  
  
  RESULTS
  No floor or ceiling effects were observed for VEINES-QOL items, item-item correlations were weak to moderate, item-score correlations were moderate. Internal reliability was good. The VEINES-Sym subscale was confirmed by factor analysis. Test-retest reliability was satisfactory for the scale scores; individual items showed moderate to good agreement. Relationships with SF-12, pain, and the quality items confirmed construct validity. Participants whose ulcers had healed showed greater mean increase in scores than did those yet to heal, though they continued to report leg problems. An intrinsic scoring method appeared superior to the original relative method.
  
  
  CONCLUSIONS
  VEINES-QOL was suitable for use in the study of venous leg ulcers. The intrinsic scoring method should be adopted, to facilitate comparisons between studies.
  
  
  BACKGROUND
  VenUS IV is registered with the ISRCTN register, number ISRCTN49373072 .
authors.affiliation: Deparment of Health Sciences, University of York, York, YO10 5DD, UK. martin.bland@york.ac.uk.
authors.forename: J Martin
authors.initials: JM
authors.lastname: Bland
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. jo.dumville@manchester.ac.uk.
authors.forename: Jo C
authors.initials: JC
authors.lastname: Dumville
authors.affiliation: Deparment of Health Sciences, University of York, York, YO10 5DD, UK. rebecca.ashby@york.ac.uk.
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Ashby
authors.affiliation: Deparment of Health Sciences, University of York, York, YO10 5DD, UK. rhian.gabe@york.ac.uk.
authors.forename: Rhian
authors.initials: R
authors.lastname: Gabe
authors.affiliation: Leeds Community Healthcare NHS Trust St Mary's Hospital, Greenhill Road, Armley, LS12 3QE, UK. nikki.stubbs2@nhs.net.
authors.forename: Nikki
authors.initials: N
authors.lastname: Stubbs
authors.affiliation: School of Health and Social Care, Baines Wing, University of Leeds, Leeds, LS2 9JT, UK. u.adderley@leeds.ac.uk.
authors.forename: Una
authors.initials: U
authors.lastname: Adderley
authors.affiliation: Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK. arthur.kangombe@gmail.com.
authors.forename: Arthur R
authors.initials: AR
authors.lastname: Kang'ombe
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. nicky.cullum@manchester.ac.uk.
authors.forename: Nicky A
authors.initials: NA
authors.lastname: Cullum
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D058128:Compression Bandages; D005163:Factor Analysis, Statistical; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011788:Quality of Life; D015203:Reproducibility of Results; D053828:Stockings, Compression; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000628:therapy*