AttachmentJ6_inclusioncriteriav4.pdf

Attachment J.6 CIREN Phase 4 Inclusion Criteria

CIREN Inclusion Criteria – Motor Vehicle Occupants 2016-2021 Version 4.0

Adult (13 years and older)

Preferred Extended (same as Preferred except where noted)

Vehicle criteria

Restraint criteria Occupant position Injury severity*

Vehicle criteria

Restraint criteria

Occupant position

Injury severity

Notes

Frontal Crashes – generally 10 o’clock to 2 o’clock impact angle with front plane damage CY-6 (+SC) 3pt belt NGM + deployed frontal bag

Row 1 outboard AC + Brain Deployed frontal bag (unbelted)

MY1998+ 3pt belt NGM Rows 2+ AC + Brain MY1998+ 3pt belt NGM + deployed frontal bag

Row 1 outboard TLS

Side Crashes – generally 8 o’clock to 10 o’clock or 2 o’clock to 4 o’clock impact angle with side plane damage CY-6 (+SC) Any Near-side any row AC + Brain MY2005+ Side torso and head bag deployment

MY2005+ 3pt belt NGM Far-side any row AC + Brain Rollover Crashes

CY-6

(+SC)

3pt belt Any AC

Success Cases – high-energy crashes with minor or no injury to case occupant while other properly-restrained occupants seriously injured

CY-6

(+SC)

3pt belt Any Any Requires NHTSA pre-approval CY=calendar year, MY=model year, SC=sisters and clones, NGM=no gross misuse (lap and shoulder belt positioned over occupant as designed)

* See injury severity descriptions on following page. AC=adult conventional, TLS=thoracolumbar spine

Vehicle criteria descriptions

CIREN is focused on injury causation in newer vehicles, and has typically based its inclusion criteria on the model year of the case vehicle being six or fewer years older than the calendar year at the time of enrollment (CY-6). For example, in calendar year 2017, a 2011 model year vehicle would qualify based on CY-6. Child cases may be enrolled based on an eight year age limit (CY-8).

As an extension to the six year age limit for the CY-6 criterion, NHTSA allows older vehicles to be enrolled if no major chassis and safety technology changes have taken place within a generation of a vehicle make/model that is eligible in its newer model years. NHTSA references the sisters and clones database maintained by Scalia Safety Engineering to make this determination. For example, a 2008 Honda Accord would qualify as a sister/clone (SC) if enrolled in 2017 since that generation runs from 2008 through 2012 model years (cutoff for CY-6 is 2011 model year). NHTSA approval is required for all SC enrollments.

Additionally, some conditions are eligible for even broader vehicle model year inclusion. These are noted with MY1998+ of MY2005+ for circumstances that allow 1998 and newer or 2005 and newer vehicles to be enrolled.

Injury severity descriptions (using AIS 2005/08)

Adult Conventional (AC) – One AIS 3+ injury, 2 AIS 2+ injuries (with medical significance) in two different AIS body regions, AIS 2 lower extremity fracture with significant articular involvement (e.g. pilon, talus, calcaneus, Lisfranc, Chopart’s), AIS 2 brain lesion, AIS 2 rib fracture, AIS 2 spinal column fracture (excluding process), AIS 2 upper extremity fracture requiring invasive treatment or with significant comminution/displacement, AIS 2 acetabulum fracture requiring invasive treatment, AIS 2 pelvic ring disruption, AIS 2 external soft tissue trauma (avulsion/burn/complex laceration) requiring reconstruction and/or complex closure

Brain – Isolated AIS 2+ anatomical brain injury or combination of AIS 2+ concussive injury and MAIS 1 for all other injury (concussive injury requires well-documented LOC at time of crash, no anatomical brain injury diagnosed during CIREN center admission, CT or MRI performed within 24 hours of admission, GCS decreased or occupant is amnestic to event, no illicit drugs or alcohol at time of crash)

Thoracolumbar Spine (TLS) – AIS 2+ vertebral body fracture in T10-L5 region (case occupant’s seat must be properly documented)

Child Conventional (CC) – AIS 2+ injury anywhere without restriction

Children (12 years and younger)

Preferred

Vehicle criteria

Restraint criteria Occupant position Injury severity* Notes

Frontal Crashes – generally 10 o’clock to 2 o’clock impact angle with front plane damage CY-8 (+SC) 3pt belt or CRS used NGM Any CC MY1998+ 3pt belt NGM Rows 2+ CC

Side Crashes – generally 8 o’clock to 10 o’clock or 2 o’clock to 4 o’clock impact angle with side plane damage CY-8 (+SC) Any Near-side any row CC MY2005+ 3pt belt NGM Far-side any row CC

Rear – generally 5 o’clock to 7 o’clock impact angle with rear plane damage MY1998+ CRS used NGM Row 2+ CC

Rollover Crashes CY-8 (+SC) 3pt belt or CRS used NGM Any CC

Success Cases – high-energy crashes with minor or no injury to case occupant while other properly-restrained occupants seriously injured

CY-8 (+SC) 3pt belt or CRS used NGM Any Any CY=calendar year, MY=model year, SC=sisters and clones, NGM=no gross misuse (appropriate belt/harness positioning and/or CRS installation)

* See injury severity descriptions on previous page. CC=child conventional

Exclusions (ineligible for all case and occupant types)

• Case vehicles experiencing catastrophic impacts with substantial reduction in occupant survival space – NHTSA shall make the final determination of case eligibility

• Non-admitted fatal occupants lacking a complete CT or MRI injury record or complete internal autopsy documentation

• Case vehicles experiencing fire damage to the relevant portion of the occupant compartment

• Child Restraint System (if used) not available for inspection

Case Equivalent Values – Motor Vehicle Occupants

CIREN entails three different levels of cases that contribute differently to the overall effective case count. This allows flexibility in dealing with availability of suitable cases and encourages centers to perform more thorough data collection efforts. The three types of cases are Basic, Standard, and Enhanced. The three types of cases will have different Case Equivalent Values (CEV), and those values can be increased or decreased based on modifiers. The effective case count, to be determined on an annual basis, is calculated as the sum of each case CEV.

𝑛𝑛𝑒𝑒𝑒𝑒𝑒𝑒 = �𝐶𝐶𝐶𝐶𝐶𝐶𝑖𝑖

𝑛𝑛 𝑖𝑖=1

Basic: Basic CIREN cases shall meet the Extended inclusion criteria and include digital radiology. The CEV for a Basic case is 0.5.

Standard: Standard CIREN cases shall meet the Preferred inclusion criteria and include digital radiology and an EDR report acquired from the case vehicle (if supported by latest Bosch CDR software). The CEV for a Standard case is 1.0.

Enhanced: Enhanced CIREN cases shall meet the requirements for a Standard case and include patient photos (of external injuries – clinical or autopsy), details about crash avoidance technology in the case vehicle (presence and activation in crash), photos and damage measures from the opposing vehicle(s) (if applicable) to support reconstruction, include no more than one crash event for the case vehicle, and include high-resolution (maximum 1 mm slice thickness) DICOM data to support reconstructions. The CEV for an Enhanced case is 1.5.

In addition to the above three categories, the following modifying factors can increase or decrease the CEV for a given case:

• Photos and measurements of exemplar vehicle with similarly-sized occupant (±5% weight and ±2% height) in appropriate seating position (+0.1 for any case)

• EDR report (+0.1 for Basic cases, -0.1 if not available for an Enhanced case regardless of available support)

• Patient photos showing external injuries (+0.1 for Basic or Standard cases)

• Details about crash avoidance technology in case vehicle (+0.1 for Basic or Standard cases)

• Photos and damage measures from the opposing vehicle(s) (+0.1 for Basic or Standard cases)

• Single event crash (+0.1 for Basic or Standard cases)

• Enrollment of qualifying seriously injured occupant in a same vehicle as a Success case (+0.1 for Success case)

• Occupant seating position equipped with deployed knee bolster air bag, seat pan air bag, or inflatable belt (+0.1 for any case)

• Case vehicles experiencing off-road terrain vertical change of more than 240 cm in the event sequence (-0.2 for Basic or Standard cases, ineligible as Enhanced)

• Case vehicles experiencing off-road terrain gradient change of more than 30 degrees in the event sequence (-0.2 for Basic or Standard cases, ineligible as Enhanced)

• Case vehicles experiencing two or more severe impacts (-0.2 for Basic cases, -0.4 for Standard cases, ineligible as Enhanced), where severe impact is classified as:

o Front plane impact with CDC extent zone greater than 2 o Side plane impact with more than 15 cm of occupant compartment intrusion o Side plane impact with CDC extent zone greater than 2 in front or rear side planes (SHL=F or B; if no occupant compartment involvement) o Swiping impact with more than 15 cm of occupant compartment intrusion o Rollover top plane impact with CDC extent zone greater than 3 at case occupant position o Override or underride where hood/trunk and/or top of fenders are involved with more than 25 cm of occupant compartment intrusion o Undercarriage impact with crush or bending of vehicle structural components o Consult with NHTSA in the event of uncertainty – NHTSA shall make the final determination of case eligibility and resultant CEV in the event of unusual multi-event crashes