Sensitivity of clinician‐assessed efficacy outcome measurement instruments in trials of topical therapies for atopic dermatitis: a systematic review and meta‐analysis
Bibliographic record
Abstract
The rising prevalence of atopic dermatitis (AD) in developing countries and its substantial socioeconomic impact have furthered research over the last two decades giving way to advances in its aetiopathogenesis and treatment. Topical therapies targeting newly identified AD signalling pathways are being developed. Numerous clinician-assessed disease severity outcome measurement instruments (OMIs) are available to evaluate the efficacy of investigational treatments in proof-of-concept (POC) trials for AD. However, little is known about the comparative sensitivity of these efficacy OMIs. We performed a systematic review and meta-analysis to compare the sensitivity of different OMIs in controlled trials of topical therapies for AD published between January 1, 2000 and April 7, 2020. Treatment effect size of OMIs reported at Week 4 was calculated with 95% Confidence Interval (CI). The sensitivity of OMIs was compared by pooling the standardized difference between means (Cohen's d and Cohen's h) for any two OMI-parameter combinations that were reported in ≥3 studies identified in our systematic review. Assessed parameters were difference between active and vehicle at Week 4 and change from baseline [CFB] and percentage change from baseline [%CFB] at Week 4. We identified a total of 15 studies with 3313 subjects examining 14 different OMIs were included in this quantitative meta-analysis. Continuous OMIs had a significantly higher treatment effect size vs. dichotomous OMIs (P = 0.006). Comparisons of Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), body surface area (BSA) and SCORing Atopic Dermatitis (SCORAD) for available parameters were performed and generally had a similar sensitivity, with BSA showing smaller overall effect size estimates. In conclusion, continuous OMIs used in topical clinical trials for AD had significantly higher treatment effect sizes when compared to dichotomous OMIs. Continuous OMIs could provide more power for POC trials with a small sample size in atopic dermatitis with topical therapies.
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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 | 0.129 | 0.238 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.030 | 0.074 |
| Bibliometrics | 0.009 | 0.010 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.007 | 0.004 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".