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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
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    • Technical Review
    • Clinical Review
      • 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
              • referral-optimisation
                • Armstrong 2018 — Online vs in-person care for psoriasis: equivalency RCT
                • Chuchu 2018 — Cochrane review: teledermatology for diagnosing skin cancer in adults
                • Eminović 2009 — Cluster RCT: teledermatology reduces dermatology referrals
                • Finnane 2017 — Teledermatology for the diagnosis and management of skin cancer: systematic review
                • Giavina-Bianchi 2020 — Teledermatology reduces referrals and waiting times (São Paulo, 30,976 patients)
                • Jain 2021 — AI tool for skin-condition diagnosis by PCPs and NPs in teledermatology
                • Moreno-Ramirez 2007 — Store-and-forward teledermatology in skin-cancer triage (Seville, 2,009 teleconsultations)
                • Snoswell 2016 — Cost-effectiveness of store-and-forward teledermatology: systematic review
                • Whited 2013 — Clinical-course outcomes: store-and-forward teledermatology vs. conventional consultation RCT
              • 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
  • referral-optimisation
  • Chuchu 2018 — Cochrane review: teledermatology for diagnosing skin cancer in adults

Chuchu 2018 — Cochrane review: teledermatology for diagnosing skin cancer in adults

Citation​

Chuchu N, Dinnes J, Takwoingi Y, Matin RN, Bayliss SE, Davenport C, et al. Teledermatology for diagnosing skin cancer in adults. Cochrane Database Syst Rev. 2018 Dec 4;12(12):CD013193. DOI: 10.1002/14651858.CD013193.

Study design and population​

Cochrane-grade systematic review of diagnostic-accuracy studies; 22 studies included; QUADAS-2 risk-of-bias assessment. Adults with skin lesions assessed for skin cancer via teledermatology vs. in-person dermatologist or histopathology reference.

Reported metrics​

  • Pooled summary sensitivity for correct malignant classification via photographic images: 94.9 % (95 % CI 90.1–97.4); specificity 84.3 % (95 % CI 48.5–96.8)
  • Referral-accuracy analyses: teledermatology correctly triaged > 90 % of lesions that face-to-face specialists considered to require action
  • 7 studies reported diagnostic accuracy for any skin cancer; 9 for invasive melanoma; 4 for BCC; 6 reported only referral accuracy

Surrogate-to-outcome linkage​

Cochrane-grade evidence linking teledermatology triage to the patient-relevant outcome of appropriate referral for suspected skin cancer. Formally confirms referral accuracy as a clinically accepted endpoint for teledermatology and, by analogy, for AI-triage CDS devices operating in the same workflow.

CRIT1–7 appraisal​

CriterionScoreJustification
CRIT1 Relevance3Direct — teledermatology skin-cancer triage.
CRIT2 Methodology3Cochrane methodology; QUADAS-2; formal diagnostic-test-accuracy review.
CRIT3 Reporting3Pooled sensitivity / specificity with 95 % CIs reported.
CRIT4 Applicability3Directly applicable; Cochrane-grade authority for HTA / regulator.
CRIT5 Evidence weight3Cochrane systematic review — highest tier.
CRIT6 Risk of bias2Heterogeneity precluded full pooling; many constituent studies observational.
CRIT7 Contribution3Core aggregate anchor — highest evidence-quality endorsement of referral-accuracy metrics.

Aggregate: very strong.

Limitations and notes​

Heterogeneity constrained meta-analytic pooling; specificity CI very wide (48.5–96.8) reflecting that heterogeneity.

Strength as anchor​

Very strong — Cochrane-grade anchor for the accepted-surrogate claim. Regulator-facing weight maximal. Pairs with Finnane 2017 and Bourkas 2023 as the systematic-review core of Domain 3.

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Eminović 2009 — Cluster RCT: teledermatology reduces dermatology referrals
  • Citation
  • Study design and population
  • Reported metrics
  • Surrogate-to-outcome linkage
  • CRIT1–7 appraisal
  • Limitations and notes
  • Strength as anchor
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