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              • diagnostic-accuracy
              • referral-optimisation
              • severity-assessment
                • EMA 2004 — Guideline on clinical investigation of medicinal products for psoriasis (CHMP/EWP/2454/02)
                • Fink 2018 — Inter- and intra-observer variability of image-based PASI
                • Huang 2023 — AI-based PASI severity assessment: real-world study (SkinTeller)
                • King 2022 — Baricitinib BRAVE-AA1 / BRAVE-AA2 (SALT as FDA / EMA primary endpoint)
                • Mattei 2014 — PASI ↔ DLQI correlation in biologic RCTs (r² = 0.80)
                • Mrowietz 2011 — European treat-to-target consensus for moderate-to-severe psoriasis
                • Olsen 2004 — Alopecia areata investigational assessment guidelines (SALT definition, NAAF)
                • Schaap 2022 — CNN-based automated PASI scoring
                • Schmitt 2014 — HOME IV: EASI as core instrument for clinical signs of atopic eczema
                • Simpson 2016 — Dupilumab SOLO 1 and SOLO 2 (EASI / IGA as regulatory primary endpoints)
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            • Surrogate-Endpoint Validity in Dermatology AI — Structured Literature Review
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  • severity-assessment
  • Schaap 2022 — CNN-based automated PASI scoring

Schaap 2022 — CNN-based automated PASI scoring

Citation​

Schaap MJ, Cardozo NJ, Patel A, de Jong EMGJ, van Ginneken B, Seyger MMB. Image-based automated Psoriasis Area Severity Index scoring by Convolutional Neural Networks. J Eur Acad Dermatol Venereol. 2022 Jan;36(1):68–75. DOI: 10.1111/jdv.17711. PMID 34653265.

Study design and population​

Retrospective deep-learning validation of CNNs for automated PASI sub-scoring. 5,844 anonymised images from the Child-CAPTURE registry (Netherlands). Region-specific networks trained on 576 trunk, 614 arm and 541 leg image series; compared vs. real-life PASI sub-scores and 5 PASI-trained physicians.

Reported metrics​

  • Trunk ICCs (CNN vs. real-life physician): erythema 0.616; desquamation 0.580; induration 0.580; area 0.793
  • Physician inter-rater ICCs (image-based): 0.706–0.793
  • CNN matched or outperformed image-based physician scoring on area (0.793 vs. 0.694)
  • Similar performance for arms and legs

Surrogate-to-outcome linkage​

Demonstrates that CNN-based automated PASI achieves inter-rater agreement in the trained-physician range — the analytic-validity evidence that an AI severity-scoring device can substitute for or complement manual PASI. Anchors the claim that CDS-generated PASI outputs are valid for PASI-75 / PASI-90 treatment-response classification.

CRIT1–7 appraisal​

CriterionScoreJustification
CRIT1 Relevance3Direct — AI PASI, same technical modality as the intended device output.
CRIT2 Methodology2Retrospective, multi-region CNN design with physician comparators.
CRIT3 Reporting2Point-estimate ICCs per region per sub-score; no 95 % CIs.
CRIT4 Applicability3Image-based, matches CDS-device modality.
CRIT5 Evidence weight1Retrospective validation.
CRIT6 Risk of bias2Single-centre registry; head region excluded; single treating-physician reference for sub-scores; skin-type homogeneity.
CRIT7 Contribution3Central anchor — most rigorous published demonstration that AI PASI concordance matches expert panels.

Aggregate: strong.

Limitations and notes​

Head region excluded; single-centre; possible skin-type homogeneity; sub-score ICCs moderate (0.58–0.62 for erythema/desquamation/induration) though area scoring excellent.

Strength as anchor​

Strong — the primary modern reference demonstrating AI-PASI analytic validity. Paired with Meienberger 2020 (U-Net area segmentation) and Huang 2023 (AI PASI outperforms 43 dermatologists at sub-score level) to span the automated-scoring evidence base.

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Schmitt 2014 — HOME IV: EASI as core instrument for clinical signs of atopic eczema
  • Citation
  • Study design and population
  • Reported metrics
  • Surrogate-to-outcome linkage
  • CRIT1–7 appraisal
  • Limitations and notes
  • Strength as anchor
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