Evidence map›Paper›PMID 26260973›Full record

Trial reportBMC cardiovascular disorders2015

Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial.

J Martin Bland, Jo C Dumville, Rebecca L Ashby, Rhian Gabe, Nikki Stubbs, Una Adderley, Arthur R Kang'ombe, Nicky A Cullum

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialValidation Study
In one paragraph

Trial report in BMC cardiovascular disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04714749 (Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04714749 nacompletednot on this mapstarted 2021, after this paper: background citation

Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue

TypeinterventionalSponsorClinique PasteurRan2021 to 2024Enrolled38ConditionsVenous Leg UlcerArmsEndovenous treatment, Cyanoacrylate glue
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.

  1. Investigating quality of life instrument measurement properties for adults with active venous leg ulcers: A systematic review.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society · 2022
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. [Diagnosis and treatment of varicose veins].Dermatologie (Heidelberg, Germany) · 2026
    Review
  8. Article
  9. A state-of-the-art review of quality-of-life assessment in venous disease.Journal of vascular surgery. Venous and lymphatic disorders · 2024
    Review
  10. Quality of life in oncological patients with venous thromboembolic disease.Research and practice in thrombosis and haemostasis · 2024
    Review
  11. Observational
  12. Article
  13. Article
  14. Article
  15. S2k guidelines: diagnosis and treatment of varicose veins.Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2022
    Review
  16. Effects of physical activity as an adjunct treatment on healing outcomes and recurrence of venous leg ulcers: A scoping review.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society · 2022
    Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

J Martin BlandDeparment of Health Sciences, University of York, York, YO10 5DD, UK. martin.bland@york.ac.uk.
Jo C DumvilleSchool of Nursing, Midwifery and Social Work, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. jo.dumville@manchester.ac.uk.
Rebecca L AshbyDeparment of Health Sciences, University of York, York, YO10 5DD, UK. rebecca.ashby@york.ac.uk.
Rhian GabeDeparment of Health Sciences, University of York, York, YO10 5DD, UK. rhian.gabe@york.ac.uk.
Nikki StubbsLeeds Community Healthcare NHS Trust St Mary's Hospital, Greenhill Road, Armley, LS12 3QE, UK. nikki.stubbs2@nhs.net.
Una AdderleySchool of Health and Social Care, Baines Wing, University of Leeds, Leeds, LS2 9JT, UK. u.adderley@leeds.ac.uk.
Arthur R Kang'ombeLiverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK. arthur.kangombe@gmail.com.
Nicky A CullumSchool of Nursing, Midwifery and Social Work, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. nicky.cullum@manchester.ac.uk.
University of York · GBUniversity of Manchester · GBLeeds Community Healthcare NHS Trust · GBLiverpool School of Tropical Medicine · GBUniversity of Leeds · GB

Funding

Department of Health 07/60/26
6 · The paper itself

Abstract

backgroundVEINES-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.

methodsFour 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.

resultsNo 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.

conclusionsVEINES-QOL was suitable for use in the study of venous leg ulcers. The intrinsic scoring method should be adopted, to facilitate comparisons between studies.

trial registrationVenUS IV is registered with the ISRCTN register, number ISRCTN49373072 .

Indexed as

Compression BandagesQuality of LifeStockings, CompressionAgedAged, 80 and overFactor Analysis, StatisticalFemaleHumansMaleMiddle AgedPain MeasurementReproducibility of ResultsSurveys and QuestionnairesTreatment OutcomeVaricose Ulcer

Identifiers

PMID26260973
PMCPMC4531536
OpenAlexW2101732233

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.