Development and Evidence-Based Validation of a Comprehensive Framework for Neurointerventional Laboratory Certification: The 6P Protocol Systematic Review Comprehensive Framework for Neurointerventional Laboratory Certification: The 6P Protocol

Abstract

Background and Objectives— Neurointerventional laboratory standards vary significantly worldwide, lacking comprehensive evidence-based certification frameworks. We developed and validated a novel 6P Protocol (People, Place, Products, Protocols, Performance, Protection) encompassing 33 evidence-based standards for neurointerventional laboratory certification.

Methods— We developed the 6P Protocol through a modified Delphi process involving 15 international experts. The framework underwent external validation by 7 independent experts. We conducted systematic evidence review of 33 subsections using 142 high-quality studies. Evidence quality was classified using GRADE methodology as HIGH (Grade A), MODERATE (Grade B), or LOW (Grade C). Recommendation strength was categorized as Strong FOR, Conditional FOR, or Conditional AGAINST.

Results— Unanimous expert consensus was achieved on the final framework. Of 33 subsections, 14 (42.4%) received Grade A evidence, 12 (36.4%) Grade B, and 7 (21.2%) Grade C. Fourteen subsections (42.4%) received Strong FOR, 17 (51.5%) Conditional FOR, and 2 (6.1%) Conditional AGAINST recommendations. Protection domain showed highest Grade A evidence proportion (66.7%), followed by Protocols (50.0%).

Conclusions— The 6P Protocol demonstrates robust scientific grounding, with over three-quarters of subsections supported by moderate-to-high quality evidence. Structured implementation is recommended, prioritizing Grade A subsections with immediate safety impact. This provides the first comprehensive evidence-based framework for neurointerventional laboratory certification.