Publications by authors named "M I van Raath"
Background: There is limited evidence on the best available treatment options for capillary malformations (CMs), mainly due to the absence of uniform outcome measures in trials on therapies. A core outcome set (COS) enables standard reporting of trial outcomes, which facilitates comparison of treatment results.
Objectives: To develop a core outcome domain set (CDS), as part of a core outcome set (COS), for clinical research on CMs.
Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project).
J Eur Acad Dermatol Venereol
September 2021
Background: Due to a large variety in treatment outcomes reported in therapeutic trials and lacking patient-relevant outcomes, it is hard to adequately compare and improve current therapies for patients with capillary malformations (CMs). The Core Outcome Set for Capillary Malformations (COSCAM) project aims to develop a core outcome set (COS) for use in future CM trials, in which we will first develop a core outcome (sub)domain set (CDS). Here, we describe the methods for the development of a CDS and present the results of the first development stage.
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- A systematic review evaluated the validity and measurement properties of outcome measurement instruments (OMIs) used in port wine stain (PWS) treatment, uncovering significant concerns about their reliability and effectiveness.
- The review included 8 studies but found that most OMIs had inadequate development and lacked thorough evaluations of their content validity and other important metrics.
- Overall, the evidence suggested that the available OMIs have varying degrees of quality, with many lacking essential studies on responsiveness and inter-rater reliability.
Antifibrinolytic site-specific pharmaco-laser therapy (SSPLT) is an experimental treatment modality for refractory port wine stains (PWS). Conceptually, antifibrinolytic drugs encapsulated in thermosensitive liposomes are delivered to thrombi that form in semi-photocoagulated PWS blood vessels after conventional laser treatment. Local release of antifibrinolytics is induced by mild hyperthermia, resulting in hyperthrombosis and complete occlusion of the target blood vessel (clinical endpoint).
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- - The study investigated the variety of outcome measures used in port wine stain (PWS) research to identify inconsistencies that hinder treatment comparisons and meta-analyses.
- - A total of 85 studies with over 3,300 patients were reviewed, revealing 46 different clinical efficacy scoring systems, with only 44% of studies being comparable due to this variability.
- - The authors concluded that creating a consensus-based core outcome set is essential for improving future PWS research and clinical practices, especially given the limited number of high-quality trials.