Protocol for the development of core set of domains of the core outcome set for patients with congenital melanocytic naevi (OCOMEN project)

Oei, Welling; Fledderus, Anne C.; Korfage, Ida J.; Eggen, C.A.M.; Horst, Chantal M.A.M. van der; Spuls, Phyllis I.; Brinkmann, Saskia J. H.; Wolkerstorfer, Albert; Kessel, M van; Pasmans, Suzanne G.M.A.

doi:10.1111/jdv.15874

Cited by 10 publications

(37 citation statements)

References 20 publications

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“…Furthermore, the domain ‘histopathology’ was renamed as ‘pathology’ because ‘pathology’ describes not only histological findings but also molecular findings. The selection of the top five domains for the CDS and the opportunity to alter the classification of domains were an additional step to promote future uptake, and had not been specified in the initial protocol 24 …”

Section: Resultsmentioning

confidence: 99%

Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research*

Oei

Fledderus

Spuls³

et al. 2021

Br J Dermatol

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Summary Background Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN. Objectives Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the ‘what to measure’ aspect, the so‐called core domain set (CDS), following the COMET and CS‐COUSIN guidelines. Methods We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient‐reported outcomes. All these outcomes were classified into domains. Through e‐Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS. Results We reached consensus on six domains, four of which were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research. Conclusions We have developed a CDS for medium‐to‐giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.

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Section: Resultsmentioning

confidence: 99%

Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research*

Oei

Fledderus

Spuls³

et al. 2021

Br J Dermatol

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“…The design and number of study rounds of this three‐round e‐Delphi study are based on common methods used in previously published COS studies. 16 , 17 , 24 , 25 , 26 …”

Section: Methodsmentioning

confidence: 99%

“…We aim to include at least 100 participants in total (CM patients, parents/caregivers and CM experts). 17 Since a 30% response rate among the invited participants is commonly expected, we aim to invite a total of approximately 300 participants.…”

Section: Methodsmentioning

confidence: 99%

“… 15 Developing a COS has become a prerequisite to conduct meaningful research in the field of dermatology. 16 , 17 , 18 , 19 , 20 Delphi studies in particular have proven essential in the development of COSs, e.g. for atopic dermatitis and congenital melanocytic nevi.…”

Section: Introductionmentioning

confidence: 99%

“…for atopic dermatitis and congenital melanocytic nevi. 17 , 20 Concerning vascular malformations, such a set of outcomes was recently developed for peripheral lymphatic, venous and arteriovenous malformations in the OVAMA‐project. 16 Yet, no COS exists for CMs.…”

Section: Introductionmentioning

confidence: 99%

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Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project)

Langbroek

Wolkerstorfer

Horbach

et al. 2021

Acad Dermatol Venereol

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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. MethodsThe COSCAM project is carried out according to the recommendations of the Cochrane Skin Core OUtcomes Set INitiative (CS-COUSIN) and the Core Outcome Measures in Effectiveness Trials (COMET) initiative. During the first stage, we identified all potentially relevant outcome subdomains based on a systematic review, two focus group sessions and input from patient representatives of Dutch patient organizations and the COSCAM-founding group. In stage two, we will present the subdomains in a three-round e-Delphi study and online consensus meeting, in which CM patients, parents/caregivers and CM experts worldwide rate the importance of the proposed subdomains, hereby finalizing the core outcome (sub)domains of the CDS.Results A total of 67 potential outcome subdomains were included; sixteen were previously used in the literature, 20 were proposed by Dutch patients and their parents/caregivers (n = 13) in focus group sessions and 38 were suggested by the experts of the COSCAM-founding group. Seven were excluded because of overlap. ConclusionThe final CDS may serve as a minimum standard in future CM trials, thereby facilitating adequate comparison of treatment outcomes. After this CDS development, we will select appropriate outcome measurement instruments to measure the core outcome subdomains.

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Safety and effectiveness of surgical excision of medium, large, and giant congenital melanocytic nevi: A systematic review and meta-analysis

Gout

Fledderus²,

Lokhorst³

et al. 2023

Journal of Plastic, Reconstructive & Aesthetic Surgery

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Protocol for the development of core set of domains of the core outcome set for patients with congenital melanocytic naevi (OCOMEN project)

Cited by 10 publications

References 20 publications

Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research*

Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research*

Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project)

Safety and effectiveness of surgical excision of medium, large, and giant congenital melanocytic nevi: A systematic review and meta-analysis

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