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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.0
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    • Technical Review
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      • Round 1
        • Item 0: Background & Action Plan
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
        • Item 7: Risk
        • completed-tasks
          • task-3b10-legacy-pms-document-hierarchy-refactor
          • task-3b11-sme-coverage-subspecialty-documentation
          • task-3b12-phase-1-exploratory-per-bucket-c-feature
          • task-3b13-man-2025-cep-cip-completeness
          • task-3b14-ifu-integration-requirements-verification
          • task-3b4-mrmc-dark-phototypes
          • task-3b6-surrogate-endpoint-literature-review
            • Appraisal log — CRIT1–7 rolling table
            • Do we need this task?
            • Integration map — propagation of the surrogate-endpoint validity review
            • references
              • diagnostic-accuracy
                • Conic 2018 — Impact of melanoma surgical timing on survival (NCDB)
                • Daneshjou 2022 — Disparities in dermatology AI performance on a diverse clinical image set (DDI) [BALANCING]
                • Dick 2019 — Accuracy of computer-aided diagnosis of melanoma: a meta-analysis
                • Esteva 2017 — Dermatologist-level classification of skin cancer with deep neural networks
                • Freeman 2020 — Algorithm-based smartphone apps for skin cancer risk: BMJ systematic review [BALANCING]
                • Gershenwald 2017 — AJCC 8th edition: melanoma staging and survival gradient
                • Haenssle 2018 — Man against machine: CNN vs 58 dermatologists for melanoma recognition
                • Haenssle 2020 — Man against machine reloaded: market-approved CNN (Moleanalyzer Pro) vs 96 dermatologists
                • Han 2018 — Clinical-image classification for benign and malignant tumours (cross-ethnicity) [BALANCING]
                • Liu 2020 — A deep learning system for differential diagnosis of skin diseases
                • Salinas 2024 — Systematic review and meta-analysis of AI vs. clinicians for skin cancer diagnosis
                • Tschandl 2020 — Human–computer collaboration for skin cancer recognition
                • Winkler 2023 — Dermatologists cooperating with a CNN: prospective clinical study
              • referral-optimisation
              • severity-assessment
            • Research prompts — external deep-research tools
            • Surrogate-Endpoint Validity in Dermatology AI — Structured Literature Review
          • task-3b7-icd-per-epidemiological-group-vv
          • task-3b8-safety-confirmation-column-definition
          • task-3b9-legacy-pms-conclusions-into-plus-pms-plan
        • Coverage matrix
        • resources
        • Task 3b-5: Autoimmune and Genodermatoses Triangulated-Evidence Package
      • Evidence rank & phases
      • Pre-submission review of R-TF-015-001 CEP and R-TF-015-003 CER
  • Pricing
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  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • completed-tasks
  • task-3b6-surrogate-endpoint-literature-review
  • references
  • diagnostic-accuracy
  • Conic 2018 — Impact of melanoma surgical timing on survival (NCDB)

Conic 2018 — Impact of melanoma surgical timing on survival (NCDB)

Citation​

Conic RZ, Cabrera CI, Khorana AA, Gastman BR. Determination of the impact of melanoma surgical timing on survival using the National Cancer Database. J Am Acad Dermatol. 2018 Jan;78(1):40–46.e7. DOI: 10.1016/j.jaad.2017.08.039. PMID 29054718.

Study design and population​

Retrospective population-based cohort from the US National Cancer Database (NCDB); 153,218 patients with stage I–III cutaneous melanoma. Primary analysis: time from biopsy to definitive surgical excision vs. overall survival.

Reported metrics​

Adjusted mortality hazard by time-to-surgery interval:

  • 30–59 days: +5 % worse OS
  • 60–89 days: +16 % worse OS
  • 90–119 days: +29 % worse OS
  • > 119 days: +41 % worse OS

Gradient statistically significant across all stages; full 95 % CIs in supplementary tables.

Surrogate-to-outcome linkage​

Provides the patient-outcome anchor that converts care-pathway waiting-time surrogates (teledermatology and AI triage studies — Domain 3) into a mortality linkage. The causal chain is: faster accurate triage → shorter time-to-definitive-surgery → improved overall survival. This is the numerical conversion factor from the waiting-time surrogate to the mortality outcome.

CRIT1–7 appraisal​

CriterionScoreJustification
CRIT1 Relevance3Direct — time-to-surgery in melanoma is the outcome bridge for the referral-pathway surrogate.
CRIT2 Methodology2Very large retrospective cohort; multivariable Cox regression; NCDB standard covariates.
CRIT3 Reporting2Adjusted HRs reported; 95 % CIs in supplementary tables; thorough.
CRIT4 Applicability3US registry — translatable to EU care-pathway arguments.
CRIT5 Evidence weight1Retrospective registry cohort (highest-quality available given randomisation infeasible for this question).
CRIT6 Risk of bias2Observational; residual confounding by comorbidity and staging work-up delays; overall survival (not melanoma-specific mortality) endpoint.
CRIT7 Contribution3Central anchor — without this, the waiting-time reduction surrogate lacks a quantitative outcome linkage.

Aggregate: strong.

Limitations and notes​

OS rather than melanoma-specific mortality; observational with residual confounding; US registry (EU transferability requires care).

Strength as anchor​

Strong — the key bridging reference between diagnostic-accuracy / referral-optimisation surrogates and the downstream melanoma mortality outcome. Also relevant to Domain 3 (cross-referenced in the referral-optimisation synthesis).

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Integration map — propagation of the surrogate-endpoint validity review
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Daneshjou 2022 — Disparities in dermatology AI performance on a diverse clinical image set (DDI) [BALANCING]
  • Citation
  • Study design and population
  • Reported metrics
  • Surrogate-to-outcome linkage
  • CRIT1–7 appraisal
  • Limitations and notes
  • Strength as anchor
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