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Multidisciplinary Content Validation of the GiriMok Point-of-Care Protocol for Neonatal Cyanotic Congenital Heart
Girish Gupta1, Syed Moiz Ahmed1, Richa Joshi2
1Neonatology, Graphic Era Institute of Medical Sciences, Dehradun, IND.
Insights
The GiriMok Protocol, a new point-of-care tool for neonatal cyanotic congenital heart disease, achieved unanimous expert validation. This validated protocol is ready for clinical evaluation as a critical decision-support tool.
Area of Science:
- Neonatology
- Pediatric Cardiology
- Emergency Medicine
Background:
- Neonatal cyanotic congenital heart disease presents a time-critical emergency.
- Existing guidelines lack a validated point-of-care (POC) protocol for frontline clinicians.
- The GiriMok Protocol was developed to address this critical need in diverse clinical settings.
Purpose of the Study:
- To develop and establish the content validity of the GiriMok POC Protocol.
- To ensure the protocol is suitable for immediate bedside decision-making by frontline clinicians.
- To create a rigorous, expert-validated decision-support tool for neonatal emergencies.
Main Methods:
- A four-phase iterative, multidisciplinary expert validation process was employed.
- Phase 1 involved 18 experts assessing 33 parameters; Phase 2 involved 5 specialists revalidating a 16-item instrument.
- Content Validity Index (CVI) and modified kappa (k*) were used to measure validity, with subsequent guideline-based enhancements.
Main Results:
- Phase 1 yielded a Scale-CVI/Ave of 0.927, with all items meeting validity thresholds and no safety concerns.
- Phase 2 achieved perfect scores (S-CVI/Ave = k* = 1.000) after integrating expert feedback and revisions.
- 35 expert-informed corrections led to the final GiriMok V4.0, demonstrating unanimous multidisciplinary validation.
Conclusions:
- The GiriMok POC Protocol successfully achieved unanimous multidisciplinary content validation.
- The perfect Phase 2 CVI underscores the protocol's methodological rigor and responsiveness to expert input.
- The validated GiriMok Protocol is poised for prospective clinical evaluation and national dissemination as a neonatal emergency decision-support tool.
Abstract:
Background Neonatal cyanotic congenital heart disease is a time-critical emergency requiring immediate bedside decision-making. Current guidelines lack a validated, comprehensive point-of-care (POC) protocol suitable for frontline clinicians in diverse settings. The GiriMok Protocol was developed to bridge this gap. This study aimed to develop and establish the content validity of the GiriMok POC Protocol through a rigorous four-phase iterative multidisciplinary expert validation process. Methodology This four-phase study comprised two external validation phases and two author-led refinement phases. Phase 1 involved 18 multidisciplinary experts using a 33-parameter mixed-methods instrument. Phase 2 consisted of focused revalidation by five specialists (neonatologists and a pediatric cardiologist) using a 16-item instrument with modified kappa (k*) computation. Phases 3 and 4 involved evidence-referenced enhancements against 2023-2025 guidelines and final quality assurance. Content Validity Index (CVI) was calculated at item (I-CVI) and scale (S-CVI/Ave) levels. Results In total, 18 unique validators participated across 24 episodes. Phase 1 yielded an S-CVI/Ave of 0.927, with all items meeting the I-CVI ≥0.78 threshold and zero safety concerns. Phase 2 achieved perfect scores (S-CVI/Ave = k* = 1.000) following the integration of a 22-item revision agenda. In total, 35 expert-informed corrections resulted in the final publication-ready GiriMok V4.0. Conclusions The GiriMok POC Protocol achieved unanimous multidisciplinary validation. The perfect Phase 2 CVI demonstrates methodological rigor and responsiveness to expert feedback. The protocol is now positioned for prospective clinical evaluation and national dissemination as a neonatal emergency decision-support tool.
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