A core outcome domain set for clinical research on capillary malformations (the COSCAM project): an e-Delphi process and consensus meeting

Langbroek, Ginger Beau; Wolkerstorfer, Albert; Horbach, Sophie E.R.; Spuls, Phyllis I.; Kelly, Kristen M.; Robertson, Susan J.; Raath, M Ingmar van; Al‐Niaimi, Firas; Kono, Taro; Boixeda, P.; Laubach, Hans; Badawi, Ashraf; Rubin, Agneta Troilius; Hædersdal, Merete; Manuskiatti, Woraphong; Horst, Chantal M. A. M. van der; Ubbink, Dirk T.

doi:10.1111/bjd.21723

Cited by 3 publications

(6 citation statements)

References 42 publications

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“…20 Implementing an online Delphi study may overcome some limitations found with decision-making processes in face-to-face committee meetings, with the advantage of less cost and feedback being provided in a controlled form. 21 It is commonly chosen as a way to achieve a consensus for clinical standards and the construction of scales. 22 This study utilized a two-round online Delphi method to formulate a behavioral assessment scale of consciousness for NHPs, incorporating the consciousness and behavior characteristics of NHPs and the clinical conscious behavior assessment scales used for patients with disorders of consciousness (DOC).…”

Section: Introductionmentioning

confidence: 99%

Behavioral assessment scale of consciousness for nonhuman primates: A Delphi study

Sun,

Dong,

et al. 2023

Science Progress

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Objective Nonhuman primates (NHPs) are suitable for being model animals in the study of consciousness and loss of consciousness (LoC) with a similar brain structure and function to humans. However, there is no effective consciousness assessment scale for them. This study aimed to develop a behavioral assessment scale of consciousness for NHPs. Methods We constructed an initial indicator framework based on the clinical consciousness disorder assessment scales and the physiological characteristics, consciousness, and arousal behavior of NHPs. A two-round online Delphi method was conducted by a multidisciplinary expert panel to construct a behavioral assessment scale of consciousness for NHPs. The indicators and descriptions were revised according to the experts’ feedback and then sent out for repeated consultations along with a summary of the results of the previous round of consultations. The accepted competencies of indicators were established with mean scores in two scoring criteria (importance and feasibility) ≥4.0, agreement rate with a rating of importance or essential ≥70.0%, and a coefficient of variation ≤0.25, as well as discussions of the research group. Results Consensus was achieved after the second round of consultations, which was completed by 28 experts who specialized in rehabilitation, neuroscience, psychology, neurosurgery, and neurology. A new behavioral assessment scale of consciousness for NHPs, including 37 items organized hierarchically within seven dimensions including visual function, auditory function, motor function, orofacial movements, arousal, brainstem reflexes, and respiration, was developed in this study. Conclusions This study has successfully developed a behavioral assessment scale for measuring the conscious state of NHPs or NHP models with LoC. This tool is expected to facilitate future research into the underlying mechanisms of consciousness by providing a detailed and comprehensive means of measurement.

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Section: Introductionmentioning

confidence: 99%

Behavioral assessment scale of consciousness for nonhuman primates: A Delphi study

Sun,

Dong,

et al. 2023

Science Progress

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“…Of the challenges Langbroek et al . have faced and mastered, 2 we find three particularly interesting for other groups who aim to develop COS in dermatology. Firstly, it is widely accepted that a COS needs to address the ‘what’ (domains) and the ‘how’ (instruments) to measure.…”

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confidence: 99%

“…The Core Outcome Set (COS) for clinical research on CApillary Malformations (COSCAM) initiative has now made a substantial contribution in this issue of the BJD 2 . Following state‐of‐the‐art methods 3–5 including reviews, patient input and a formal international consensus process, 11 core outcome domains were identified.…”

mentioning

confidence: 99%

“…Highly granular domains may be more difficult to develop and lead to longer lists, which may reduce participation in Delphi studies, while broad domains give shorter lists but may be too vague and therefore may be understood differently by participants. Langbroek et al 2 . focused on narrow and specific outcome domains such as ‘colour/redness’ or ‘thickness’, which is probably very useful for identifying instruments in a next step.…”

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confidence: 99%

“…Secondly, COSCAM is not the first COS group to discuss whether repeated measurements such as ‘recurrence’ 2 or ‘long‐term control’ 10 are domains, subdomains or even outcome measurement instruments. Langbroek et al 2 . have solved this issue by vote.…”

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confidence: 99%

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Core outcome domains for capillary malformations and current methodological challenges

Rönsch

Kottner

2022

British Journal of Dermatology

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Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement

Simpson

Kirtschig

Selk

et al. 2023

British Journal of Dermatology

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Background Lichen sclerosus (LS) is a chronic inflammatory condition mainly affecting genital skin. It causes distressing symptoms that impact daily quality of life (QoL). It causes progressive anatomical changes and a potential risk of cancer. Published randomised controlled trials are of varying methodological quality and difficult to combine in meta-analyses. This is partly due to lack of agreed outcome measures to assess treatment response. Identification of core outcome sets (COSs), which standardise key outcomes to be measured in all future trials, is a solution to this problem. Objectives To obtain international agreement on which outcome domains should be measured in interventional trials of genital LS. Methods Recommended best practice for COS domain development was followed: 1) Identification of potential outcome domains: a long-list was generated through up-to-date LSliterature search, including information collected during the LS Priority Setting Partnership. 2) Provisional agreement of outcome domains: A 3-stage multi-stakeholder international electronic-Delphi consensus study; 3) Final agreement of outcome domains: Online consensus meeting with international stakeholders including anonymised voting. Results In total, 123 participants (77 patients, 44 health professionals, 2 researchers) from 20 countries completed 3 rounds of the electronic-Delphi study. 11 outcome domains were rated as ‘critical’ and were discussed at the online consensus meetings. The first set of consensus meetings involved 42 participants from 13 countries. Consensus was met for ‘symptoms’ (100% agreed) and ‘quality of lif –LS specific’ (92% agreed). After set two of meetings, involving 29 participants from 12 countries, ‘Clinical (visible) signs’ also met consensus (97% agreed). Conclusions The international community have agreed upon 3 key outcome domains to measure in all future LS clinical trials. We recommend that trialists and systematic reviewers incorporate these domains into study protocols with immediate effect. CORALS will now work with stakeholders to select an outcome measurement instrument per prioritised core domain.

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A core outcome domain set for clinical research on capillary malformations (the COSCAM project): an e-Delphi process and consensus meeting

Cited by 3 publications

References 42 publications

Behavioral assessment scale of consciousness for nonhuman primates: A Delphi study

Behavioral assessment scale of consciousness for nonhuman primates: A Delphi study

Core outcome domains for capillary malformations and current methodological challenges

Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement

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