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  • Welcome to your QMS
  • Quality Manual
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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
              • 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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  • Round 1
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  • task-3b6-surrogate-endpoint-literature-review
  • references
  • referral-optimisation
  • Whited 2013 — Clinical-course outcomes: store-and-forward teledermatology vs. conventional consultation RCT

Whited 2013 — Clinical-course outcomes: store-and-forward teledermatology vs. conventional consultation RCT

Citation​

Whited JD, Warshaw EM, Kapur K, Edison KE, Thottapurathu L, Raju S, et al. Clinical course outcomes for store and forward teledermatology versus conventional consultation: a randomized trial. J Telemed Telecare. 2013 Jun;19(4):197–204. DOI: 10.1177/1357633X13487116. PMID 23666440.

Study design and population​

Two-site, parallel-group, superiority RCT. 392 randomised / 261 analysed. US Department of Veterans Affairs primary-care-to-dermatology referrals; 9-month clinical-course rating by blinded dermatologist panel on a 5-point scale.

Reported metrics​

  • No significant difference in clinical-course ratings between teledermatology and conventional consultation at 9 months (p = 0.88)
  • No significant difference at first clinic visit (p = 0.65)
  • Waiting time to intervention substantially shorter in teledermatology arm
  • Among teledermatology referrals, subsequent in-person visit correlated with clinical course (p = 0.023) — suggests appropriate triage

Surrogate-to-outcome linkage​

RCT-level evidence that store-and-forward teledermatology-based referral produces the same 9-month clinical-course outcome as conventional consultation — validating the referral pathway metric as a genuine proxy for clinical benefit rather than a pure process measure. Supports the non-inferiority leg of the Pillar-1 argument for AI-triage pathway redesign.

CRIT1–7 appraisal​

CriterionScoreJustification
CRIT1 Relevance3Direct — SAF teledermatology pathway RCT with clinical-course outcome.
CRIT2 Methodology3Multi-site RCT; blinded outcome adjudication.
CRIT3 Reporting2Descriptive comparison; no 95 % CI for primary endpoint reported.
CRIT4 Applicability2VA predominantly male older population — EU-transferability requires care.
CRIT5 Evidence weight2RCT.
CRIT6 Risk of bias2Attrition (392 → 261 analysed); 5-point clinical-course rating is itself a surrogate.
CRIT7 Contribution3Core anchor — RCT-level outcome equivalence for skin-cancer referral pathway.

Aggregate: strong.

Limitations and notes​

VA population; attrition introduces selection bias; 9-month window may be insufficient for slow-evolving conditions.

Strength as anchor​

Strong. Together with Eminović 2009 (EU cluster RCT on referral reduction) and Armstrong 2018 (chronic-disease equivalence RCT), provides the RCT-level evidence backbone for the referral-optimisation argument.

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Snoswell 2016 — Cost-effectiveness of store-and-forward teledermatology: systematic review
Next
EMA 2004 — Guideline on clinical investigation of medicinal products for psoriasis (CHMP/EWP/2454/02)
  • Citation
  • Study design and population
  • Reported metrics
  • Surrogate-to-outcome linkage
  • CRIT1–7 appraisal
  • Limitations and notes
  • Strength as anchor
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