Consensus on core domains for hand eczema trials: Signs, symptoms, control and quality of life
Bibliographic record
Abstract
BACKGROUND: Hand eczema (HE) is a common and complex skin disease. A uniform set of core outcomes and related measures for use in clinical trials is lacking, making it difficult to compare results across HE studies. OBJECTIVE: To reach consensus on a set of core domains and subdomains that should be measured in future therapeutic HE trials. METHODS: In 2024, we conducted a two-round online Delphi (eDelphi) survey among international HE experts, including physicians, patients and their relatives, researchers and industry representatives. A domain/subdomain was included in the core set when ≥80% of participants rated is as 'critically important'; 50% agreement or less resulted in its exclusion. Results from 50% to 80% were deemed controversial and subject for further discussion. During a hybrid consensus meeting, the stakeholders reviewed, completed and, if necessary, revised the preliminary eDelphi consensus. RESULTS: In the first and second round of the eDelphi, 208 and 134 persons, respectively, participated. Forty participants from 18 countries attended the consensus meeting. Consensus was reached to include the core domains 'signs of HE' (with five core subdomains), 'symptoms of HE' (two subdomains), 'HE-related quality of life' (four subdomains) and 'HE control over time' (four subdomains). The subdomains 'desquamation/scaling' and 'emotional impact/mental health' remained controversial. Consensus was reached that the domains 'skin barrier function' and 'patient-reported treatment experience' and 28 subdomains should not be part of the core outcome set. CONCLUSIONS: To produce comparable and meaningful results, future trials evaluating the effectiveness of HE treatments should measure signs and symptoms of HE, HE-related quality of life and HE control over time as core outcome domains. The next step of the HE core outcome set initiative (HECOS) is to identify appropriate measurement instruments.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.478 | 0.444 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.004 | 0.006 |
| Bibliometrics | 0.009 | 0.005 |
| Science and technology studies | 0.005 | 0.006 |
| Scholarly communication | 0.007 | 0.008 |
| Open science | 0.008 | 0.018 |
| Research integrity | 0.011 | 0.011 |
| Insufficient payload (model declined to judge) | 0.008 | 0.004 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".