1. 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
- Author
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M S van Kessel, Sven Krengel, C. M. A. M. van der Horst, Heather C. Etchevers, W Oei, Albert Wolkerstorfer, A C Fledderus, Ph.I. Spuls, Suzanne G.M.A. Pasmans, I.J. Korfage, C.A.M. Eggen, Jan Kottner, Dermatology, APH - Methodology, APH - Quality of Care, Plastic, Reconstructive and Hand Surgery, ACS - Atherosclerosis & ischemic syndromes, AMS - Musculoskeletal Health, AMS - Rehabilitation & Development, Amsterdam Movement Sciences, ACS - Diabetes & metabolism, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Naevus International Patient Representative Working Group Leader, Dermatological group practice, Lübeck, Marseille medical genetics - Centre de génétique médicale de Marseille (MMG), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Association du Naevus Géant Congénital, Naevus 2000 France-Europe and the Asociación Española de Nevus Gigante Congénito, Gall, Valérie, and Public Health
- Subjects
medicine.medical_specialty ,Consensus ,Delphi Technique ,Best practice ,MEDLINE ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Dermatology ,Outcome (game theory) ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Quality of life (healthcare) ,[SDV.CAN] Life Sciences [q-bio]/Cancer ,melanoma ,Humans ,Medicine ,Patient Reported Outcome Measures ,Set (psychology) ,Nevus, Pigmented ,congenital nevi ,[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology ,business.industry ,outcome domains ,Core outcome set ,Focus group ,3. Good health ,Clinical trial ,Treatment Outcome ,clinical research ,Research Design ,Family medicine ,Quality of Life ,business ,Psychosocial ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
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.
- Published
- 2021