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              • diagnostic-accuracy
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              • 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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  • Mrowietz 2011 — European treat-to-target consensus for moderate-to-severe psoriasis

Mrowietz 2011 — European treat-to-target consensus for moderate-to-severe psoriasis

Citation​

Mrowietz U, Kragballe K, Reich K, Spuls P, Griffiths CEM, Nast A, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan;303(1):1–10. DOI: 10.1007/s00403-010-1080-1. PMID 20857129.

Study design and population​

European expert consensus. 4-round Delphi + face-to-face meeting; 19 dermatologists from 19 European countries. Defines treatment goals for adult moderate-to-severe plaque psoriasis on systemic therapy.

Reported outcomes​

  • Post-induction rule: ΔPASI ≥ 75 % → continue
  • ΔPASI 50–< 75 % with DLQI ≤ 5 → continue; otherwise modify
  • ΔPASI < 50 % → modify therapy
  • DLQI ≤ 5 as the patient-relevant QoL anchor

Surrogate-to-outcome linkage​

Explicitly couples PASI severity-score change with DLQI-defined QoL improvement as the joint trigger for treatment continuation vs. escalation. Canonical codification of the severity-score → treatment-optimisation → PRO benefit chain. Directly underpins the clinical-utility argument that tighter severity tracking (e.g., AI-assisted) drives better treatment titration and downstream outcomes.

CRIT1–7 appraisal​

CriterionScoreJustification
CRIT1 Relevance3Direct — defines the operational severity → treatment-decision → PRO rule.
CRIT2 Methodology2Structured 4-round Delphi; European multi-national expert panel.
CRIT3 Reporting3Decision thresholds explicitly stated.
CRIT4 Applicability3EU context, directly applicable.
CRIT5 Evidence weight2European consensus guideline (not RCT, not meta-analysis).
CRIT6 Risk of bias2Consensus rather than primary data; industry relationships disclosed.
CRIT7 Contribution3Core anchor for the treatment-titration channel of the severity-scoring argument.

Aggregate: strong.

Limitations and notes​

Pre-dates IL-17 / IL-23 biologic era where PASI-90 / PASI-100 thresholds now predominate.

Strength as anchor​

Strong — the operational link between severity score and treatment decision, explicitly coupled to HRQoL. Without Mrowietz 2011, the "tighter severity tracking improves outcomes" claim relies on inference rather than a codified rule.

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Olsen 2004 — Alopecia areata investigational assessment guidelines (SALT definition, NAAF)
  • Citation
  • Study design and population
  • Reported outcomes
  • Surrogate-to-outcome linkage
  • CRIT1–7 appraisal
  • Limitations and notes
  • Strength as anchor
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