Improvements and advances in core outcome set methodology: proceedings of the CS-COUSIN &amp; COMFA Joint Meeting

Dirr, McKenzie A.; Alam, Murad; Apfelbacher, Christian; Drewitz, Karl Philipp; Kang, Bianca Y.; Munblit, Daniel; Nekliudov, Nikita A; Seylanova, Nina

doi:10.1007/s00403-022-02341-3

Cited by 2 publications

(4 citation statements)

References 7 publications

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“…The HECOS steering group discussed whether or not ‘HE control’ was a domain of its own. After seeking advice from the HOME initiative during a session at the 2021 CS‐COUSIN & COMFA Joint Meeting, 12 it was agreed to name the domain ‘HE control over time’ and to specify that it consists of repeated measures of treatment effectiveness/efficacy, which may for instance include other core domains or a patient global assessment (see Table 2).…”

Section: Discussionmentioning

confidence: 99%

“…Forth, the HECOS steering group decided upon the optimal presentation of the items (derived from literature review, patient interviews and additional expert suggestions) for the envisaged eDelphi 9 . This was achieved with a series of online meetings and email correspondence between January and September 2021, followed by a formal voting process at the CS‐COUSIN & COMFA Joint Meeting in September 2021 12 . The process was completed by email correspondence in March 2022.…”

Section: Participants and Methodsmentioning

confidence: 99%

“…9 This was achieved with a series of online meetings and email correspondence between January and September 2021, followed by a formal voting process at the CS-COUSIN & COMFA Joint Meeting in September 2021. 12 The process was completed by email correspondence in March 2022. Finally, one author (HR) transformed the initial codes from patient interviews to the final codes and fully coded all expert suggestions, consulting a second author (AB) when in doubt.…”

Section: Categorization Of 'Long List' Itemsmentioning

confidence: 99%

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Which outcomes should be measured in hand eczema trials? Results from patient interviews and an expert survey

Rönsch

Schiffers

Ofenloch

et al. 2023

Acad Dermatol Venereol

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Background: Hand eczema (HE) is a common skin disease characterized by itch, pain and visible skin changes such as fissures, erythema and vesicles. It is not yet clear which outcome domains are most important for patients. The Hand Eczema Core Outcome Set (HECOS) initiative is developing a consented set of core domains and suitable measurement instruments for the future application in all HE trials. This includes an online Delphi survey about core domains, which requires a 'Long List' of all domains that might be important to measure. Objectives: To compile a 'Long List' of candidate outcome domains for therapeutic HE trials with suggestions from patients and experts. Methods: First, 60 patients with chronic HE were interviewed at seven study sites in Croatia, Denmark, Germany, the Netherlands and Spain. Patients were asked about domains that were important from their perspectives. Second, 185 HE experts were invited by email to complete an online survey. With an open question, they were asked to suggest up to six domains. Results: Suggestions were provided by 58 patients and 82 experts. Most patients and experts suggested to measure the domains 'signs', 'symptoms' and 'HE-related quality of life'. Specifically, >25% of patients said that less itch, pain or fissures indicated a successful treatment. Among experts, >25% suggested 'itch' and 'ability to work' as core sub-domains. Further outcomes from the domains 'HE control over time', 'patient-reported treatment experience' and 'skin barrier function' were mentioned. Conclusion: 'Itch' was rated high among patients with HE and professional HE experts. While patients emphasized fissures as important, experts underlined the ability to work. This investigation allowed us to define a 'Long List' of 7 candidate outcome domains with 58 sub-domains. From this list, a panel of stakeholders will select core domains during an online Delphi survey.

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Section: Discussionmentioning

confidence: 99%

Section: Participants and Methodsmentioning

confidence: 99%

Section: Categorization Of 'Long List' Itemsmentioning

confidence: 99%

See 1 more Smart Citation

Which outcomes should be measured in hand eczema trials? Results from patient interviews and an expert survey

Rönsch

Schiffers

Ofenloch

et al. 2023

Acad Dermatol Venereol

View full text Add to dashboard Cite

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“…To address this issue, the Core Outcome Measures in Effectiveness Trials Initiative (COMET) has further developed the concept of the core outcome set (COS)—a minimum set of outcomes that should be reported in all trials of a particular disease or condition—by providing the methodologic framework for creating core outcome sets and core outcome measures . In dermatology, the Cochrane Skin Core Outcome Set Initiative (CS-COUSIN) has merged with the Consortium for Harmonizing Outcomes Research in Dermatology (CHORD) to initiate the CHORD−COUSIN Collaboration (C3), which aims to facilitate the development of a COS for skin diseases and conditions. C3 is an umbrella organization for approximately 30 disease-specific COS groups, including the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group, which is interested in refining outcomes reporting in clinical trials of rosacea.…”

Section: Introductionmentioning

confidence: 99%

Rosacea Core Domain Set for Clinical Trials and Practice

Dirr,

Ahmed,

Schlessinger

et al. 2024

JAMA Dermatol

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ImportanceInconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea.ObjectiveTo develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice.Evidence ReviewA systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set.FindingsThe Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting.Conclusions and RelevanceThis core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

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Improvements and advances in core outcome set methodology: proceedings of the CS-COUSIN & COMFA Joint Meeting

Cited by 2 publications

References 7 publications

Which outcomes should be measured in hand eczema trials? Results from patient interviews and an expert survey

Which outcomes should be measured in hand eczema trials? Results from patient interviews and an expert survey

Rosacea Core Domain Set for Clinical Trials and Practice

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