W Oei1, A C Fledderus2, I Korfage3, C A M Eggen1, C M A M van der Horst2, P I Spuls4, S J H Brinkmann2, A Wolkerstorfer4, M van Kessel5, S Pasmans1. 1. Department of Dermatology, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands. 2. Department of Plastic, Reconstructive and Hand Surgery, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 3. Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. 4. Department of Dermatology, Amsterdam Public Health, Amsterdam University Medical Center, Amsterdam, The Netherlands. 5. Leader of Patient Representatives of Naevus International, Utrecht, The Netherlands.
Abstract
BACKGROUND: Having large congenital melanocytic naevi (CMN) is associated with a psychosocial burden on patients and their parents because of its remarkable appearance and the extra care it may require. Large CMN also pose an increased risk of malignant melanoma or neurocutaneous melanosis. There is a lack of international consensus on what important outcome domains to measure in relation to treatment. This makes it difficult to compare options, to properly inform patients and their parents, and to set up treatment policy for CMN. Therefore, we aim to develop a core outcome set (COS), i.e. the minimum set of outcomes that are recommended to be measured and reported in all clinical trials of a specific health condition. This COS can be used in the follow-up of CMN patients with or without treatment, in clinical research and practice. METHODS: In the Outcomes for Congenital Melanocytic Nevi (OCOMEN) projects, we follow the recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Core Outcomes Set Initiative (CS-COUSIN). This project entails the following: (i) a systematic review to identify the previous reported outcomes in literature; (ii) focus groups with national and international patients and parents to identify patient-important outcomes; (iii) classification of outcomes into outcome domains; (iv) e-Delphi surveys in which stakeholders (patients/parents and professionals) can rate the importance of domains and outcomes; and (v) an online consensus meeting to finalize the core outcome domains of the COS. RESULTS: The results will be disseminated by means of publication in a leading journal and presentations in international meetings or conferences. We engage international experts in CMN, both patients and professionals, to ensure the international utility and applicability of the COS.
BACKGROUND: Having large congenital melanocytic naevi (CMN) is associated with a psychosocial burden on patients and their parents because of its remarkable appearance and the extra care it may require. Large CMN also pose an increased risk of malignant melanoma or neurocutaneous melanosis. There is a lack of international consensus on what important outcome domains to measure in relation to treatment. This makes it difficult to compare options, to properly inform patients and their parents, and to set up treatment policy for CMN. Therefore, we aim to develop a core outcome set (COS), i.e. the minimum set of outcomes that are recommended to be measured and reported in all clinical trials of a specific health condition. This COS can be used in the follow-up of CMN patients with or without treatment, in clinical research and practice. METHODS: In the Outcomes for Congenital Melanocytic Nevi (OCOMEN) projects, we follow the recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Core Outcomes Set Initiative (CS-COUSIN). This project entails the following: (i) a systematic review to identify the previous reported outcomes in literature; (ii) focus groups with national and international patients and parents to identify patient-important outcomes; (iii) classification of outcomes into outcome domains; (iv) e-Delphi surveys in which stakeholders (patients/parents and professionals) can rate the importance of domains and outcomes; and (v) an online consensus meeting to finalize the core outcome domains of the COS. RESULTS: The results will be disseminated by means of publication in a leading journal and presentations in international meetings or conferences. We engage international experts in CMN, both patients and professionals, to ensure the international utility and applicability of the COS.
Authors: A C Fledderus; S G M A Pasmans; A Wolkerstorfer; W Oei; H C Etchevers; M S van Kessel; C M A M van der Horst; P I Spuls Journal: Br J Dermatol Date: 2021-07-14 Impact factor: 11.113
Authors: Anne C Fledderus; Anna Linn Widdershoven; Oren Lapid; Corstiaan C Breugem; Suzanne G M A Pasmans; Chantal M A M van der Horst; Marc M Engelen; Phyllis I Spuls Journal: Orphanet J Rare Dis Date: 2022-03-02 Impact factor: 4.123
Authors: G B Langbroek; A Wolkerstorfer; S E R Horbach; P I Spuls; K M Kelly; S J Robertson; M I van Raath; F Al-Niaimi; T Kono; P Boixeda; H J Laubach; A M Badawi; A Troilius Rubin; M Haedersdal; W Manuskiatti; C M A M van der Horst; D T Ubbink Journal: J Eur Acad Dermatol Venereol Date: 2021-06-16 Impact factor: 6.166