Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol).

Clinical Protocols Delphi Technique Humans Leg Ulcer / physiopathology Surveys and Questionnaires Treatment Outcome
Consensus Core outcome set Delphi Scoping review Venous leg ulceration

Journal

Journal of tissue viability
ISSN: 0965-206X
Titre abrégé: J Tissue Viability
Pays: England
ID NLM: 9306822

Informations de publication

Date de publication:
Aug 2021
Historique:
received: 15 10 2019
revised: 13 02 2021
accepted: 22 03 2021
pubmed: 14 4 2021
medline: 28 10 2021
entrez: 13 4 2021
Statut: ppublish

Résumé

A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.

Sections du résumé

BACKGROUND BACKGROUND
A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.
AIM OBJECTIVE
The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.
METHODS METHODS
Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.

Identifiants

DOI: 10.1016/j.jtv.2021.03.005 PMID: 33846059
pubmed: 33846059
pii: S0965-206X(21)00036-X
doi: 10.1016/j.jtv.2021.03.005
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Pagination

317-323

Informations de copyright

Copyright © 2021 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.

Auteurs

Sarah Hallas (S)

Academic Unit of Ageing and Stroke Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK. Electronic address: sarah.hallas@bthft.nhs.uk.

Andrea Nelson (A)

School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.

Susan O'Meara (S)

Kleijnen Systematic Reviews Ltd, York, UK.

Una Adderley (U)

School of Healthcare, University of Leeds, Leeds, UK.

Pauline Meskell (P)

Department of Nursing & Midwifery, Faculty of Education & Health Sciences, University of Limerick, Limerick, Ireland.

Jane Nixon (J)

Leeds Institute Health Sciences, School of Medicine, University of Leeds, UK.

Aonghus O'Loughlin (A)

Alliance for Research and Innovation in Wounds, National University of Ireland Galway, Galway, Ireland; Saolta University Health Care Group, University Hospital Galway, Galway, Ireland; School of Medicine, National University of Ireland Galway, Galway, Ireland; Bon Secours Hospital, Galway, Ireland.

Sebastian Probst (S)

HES-SO University of Applied Sciences and Arts Western Switzerland, School of Health Sciences, Geneva, Switzerland; University Hospital Geneva, Geneva, Switzerland.

Wael Tawfick (W)

Alliance for Research and Innovation in Wounds, National University of Ireland Galway, Galway, Ireland; Saolta University Health Care Group, University Hospital Galway, Galway, Ireland; School of Medicine, National University of Ireland Galway, Galway, Ireland.

Thomas Wild (T)

University Medical Center Hamburg-Eppendorf, Germany; University of Applied Science Anhalt, Institute of Applied Bioscience and Process Management, Germany; Clinic of Plastic, Hand and Aesthetic Surgery, Medical Center Dessau, University of Applied Science Anhalt, Germany; Clinic of Dermatology, Immunology and Allergology, Medical Center Dessau, Medical University Brandenburg, Theodor Fontane, Medical Center Dessau, Germany.

Georgina Gethin (G)

Alliance for Research and Innovation in Wounds, National University of Ireland Galway, Galway, Ireland; School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female

Evaluation of Low-Value Services Across Major Medicare Advantage Insurers and Traditional Medicare.

Ciara Duggan, Adam L Beckman, Ishani Ganguli et al.
1.00
Humans United States Aged Cross-Sectional Studies Medicare Part C

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

Hallie Tankha, Devyn Gaskins, Amanda Shallcross et al.
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH

questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Protocoles cliniques › Development of a core outcome set for venous...
questionsmedicales.fr › Sciences de l'information › Analyse des systèmes › Méthode Delphi › Development of a core outcome set for venous...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Development of a core outcome set for venous...
questionsmedicales.fr › Maladies de la peau et du tissu conjonctif › Maladies de la peau › Ulcère cutané › Ulcère de la jambe › Development of a core outcome set for venous...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Development of a core outcome set for venous...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Development of a core outcome set for venous...