Home/Validation Roadmap
2
Phases Complete
1
In Progress
10
Total Phases

What’s Happening Now

Phase 3 — In Progress

Content Validity

Expert panel review confirms items adequately represent the constructs they claim to measure. This is the single most important measurement property according to COSMIN.

Expert panel review: 8–12 clinicians independently rate each item for relevance, clarity, and comprehensiveness
Patient cognitive interviews: 15–25 post-craniotomy patients complete the instrument while thinking aloud
Item-level CVI scores: Each item needs I-CVI ≥ 0.78; Scale-CVI/Average ≥ 0.90
Documentation of all revisions with rationale

What Comes Next

Phase 4

Pilot Testing

Instrument administered to a sample of the target population to assess feasibility, item performance, and preliminary psychometric properties.

Phase 5

Structural Validity

Statistical analysis confirms that items group into the domains claimed by the instrument.

Full Validation Timeline

Pre-CERS: Parallel Validation Track

New Instrument — Phase 1

Pre-Craniotomy Emotional Readiness Screen (Pre-CERS)

The Pre-CERS is a 15-item preoperative screening tool that captures baseline emotional state and flags risk factors before surgery. It uses flag-based interpretation rather than a total score.

When paired with postoperative PCRES data, the Pre-CERS enables predictive validation — testing whether preoperative emotional flags predict postoperative recovery trajectories. This longitudinal design strengthens the evidence base for both instruments.

Our Methodology

The PCRES validation follows standards defined by COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) and the FDA PRO Guidance for Patient-Reported Outcome measures.

Domain Generation

The seven PCRES domains were derived through: (1) systematic review of post-craniotomy patient qualitative research identifying themes not captured by existing instruments; (2) direct patient interviews conducted in the outpatient neurosurgical setting; and (3) iterative item review by the instrument author. Domain structure is being evaluated through confirmatory factor analysis in the Phase 3 validation study.

What makes this validation effort different:

Digital-First

All data collection happens online, reducing cost and geographic barriers. Every assessment completed on pcres.org contributes to the validation dataset.

AI-Assisted Analysis

Automated scoring, workflow support, and structured data analysis reduce the manual overhead of running the validation program. Public-facing clinical language, validation status, and major content revisions are reviewed by Dr. Eric Whitney, DO before publication.

Community-Driven

Clinicians and patients participate directly through the website. Every administration is a data point. Every expert review strengthens content validity.

Fully Transparent

Every step of the validation process is visible and documented publicly on this page. No black boxes.

Public-facing clinical language, validation status, and major content revisions are reviewed by Dr. Eric Whitney, DO before publication.

Following the PHQ-9 Playbook

The PHQ-9 became the standard depression screener because Pfizer funded its development, Spitzer and Kroenke validated it across nearly 10,000 patients between 1999 and 2009, and then they made it free and public domain. Over 560 publications followed.

We are following the same principles — free, brief, validated, actionable — but with advantages they did not have: digital-first data collection, AI-driven analysis, transparent validation, and community-driven participation. The process that took a decade can move faster with modern tools.

Help Us Get There

Every assessment, every expert review, and every research collaboration brings us closer to giving post-craniotomy patients the recovery measure they deserve.