The DECLARATION Project
Research type
Research Study
Full title
The DECLARATION Project: Shared DEcision-making in a cohort of patients with CapilLary mAlfoRmATIONs - A multinational observational study
IRAS ID
295646
Contact name
Nicholas Wilson Jones
Contact email
Sponsor organisation
Swansea Bay University Health Board
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Shared decision-making (SDM) is a modern communicative approach, in which the patient and physician reach a joint decision on a therapeutic option that matches the patients’ preferences and the best available evidence. It has shown to improve quality of care by increasing patient satisfaction and compliance to therapy. It also reduces undesired care and over-treatment.
As a preference-sensitive condition, patients with capillary malformations may specifically benefit from true shared decision-making behaviour. The experienced signs and symptoms of this congenital skin condition may vary, but its disfiguring appearance often affects the patients’ psychosocial well-being. An important reason for treating capillary malformations is therefore to prevent psychological problems and improve quality of life.
However, these skin lesions are difficult to treat as capillary malformations may recur after therapy and the efficacy of current laser therapies has not improved over the last decades. In addition, there is little supportive evidence for alternative treatment options, such as camouflage therapy, surgical excision or medical tattooing. Adequately informing capillary malformation patients about all available treatment options, communicating uncertainty regarding treatment effectiveness and most importantly eliciting patient values and preferences seems inevitable. There is still little evidence regarding the extent to which shared decision-making is applied in capillary malformation care.
With this study, we aim to assess the current level of shared decision-making in capillary malformation care, through evaluation of patients' preferences regarding decision-making and assessment of SDM-behaviour in current capillary malformation care.
REC name
London - Westminster Research Ethics Committee
REC reference
21/PR/0957
Date of REC Opinion
15 Sep 2021
REC opinion
Further Information Favourable Opinion