NDD-HI 0+ & NDD-HI 2+: The Neurodevelopmental Disorders - Health Index

• Type of Clinical Outcome Assessment (COA): Caregiver or observer-reported outcome measure (CRO/ObsRO)
• Administration Mode: Self-administered
• Therapeutic Area: Neurodevelopmental Disorders
• Approximate Completion Time: NDD-HI 0+ <2 minutes; NDD-HI 2+ <7 minutes 
• Required Supervision: None
• Recall Period: Immediate point in time

Instrument Variations

For ages 0 and older:

• The Neurodevelopmental Disorders - Health Index (NDD-HI) 0+
  • Completion Time: <2 minutes (completed by a caregiver on behalf of a patient)
• The Neurodevelopmental Disorders - Health Index Short Form (NDD-HI-SF) 0+ 
  • Completion Times: <1 minute (completed by a caregiver on behalf of a patient)

For ages 2 and older:

• The Neurodevelopmental Disorders - Health Index (NDD-HI) 2+
  • Completion Times: <7 minutes (completed by a caregiver on behalf of a patient)
• The Neurodevelopmental Disorders - Health Index Short Form (NDD-HI-SF) 2+
  • Completion Times: <1 minute (completed by a caregiver on behalf of a patient)

Symptom Subscales

• NDD-HI 0+ Number of Independently Validated Symptom Subscales:12
  • Behavioral Issues; Muscle Weakness; Problems Using their Hands, Fingers, or Arms; Emotional Issues; Trouble Sleeping or Daytime Sleepiness; Appearing Drained or Tired; Pain; Choking or Swallowing Issues; Gastrointestinal (Stomach) Issues; Breathing Difficulties; Seizures; Abnormal Movements
• NDD-HI 2+ Number of Independently Validated Symptom Subscales:17
  • Behavioral Issues; Muscle Weakness; Problems Using their Hands, Fingers, or Arms; Emotional Issues; Difficulty Thinking; Trouble Sleeping or Daytime Sleepiness; Inability to do Activities; Appearing Drained or Tired; Pain; Choking or Swallowing Issues; Gastrointestinal (Stomach) Issues; Difficulty Communicating; Breathing Difficulties; Seizures; Abnormal Movements; Impaired Social Interactions; Hip, Thigh, or Knee Weakness

Instrument Attributes

• The NDD-HI 0+ and NDD-HI 2+ are caregiver-reported outcome (CRO/ObsRO) measures designed to assess symptoms and health-related quality-of-life from the perspective of caregivers of individuals with neurodevelopmental disorders ages 0 and older, and ages 2 and older respectively.
• Designed and validated to fully satisfy regulatory and published FDA guidance for use in drug-labeling claims and measuring changes in how a patient feels and functions.
• The NDD-HI 0+ and NDD-HI 2+ were developed using extensive caregiver input, including an analysis of 16,021 caregiver quotes and a large cross-sectional study involving 404 caregivers.
• The NDD-HI 0+ and NDD-HI 2+ are highly relevant to patients, has low participant burden, and correlates with markers of disease severity.
• Utilized in industry sponsored clinical trials.
• eCOA Implementation Guide available.

Instrument Scoring

The NDD-HI 0+ and NDD-HI 2+ symptom questions within each subscale are weighted based on participant-reported prevalence and average impact as identified through the cross-sectional study. In addition to scoring utilizing aggregate NDD-HI reported prevalence and average impact, the NDD-HI may alternatively be scored using data specific to Fragile X, SHANK3, SYNGAP1, SCN2A, or SMS populations. All subscales are scored on a scale of 0 to 100 with 0 representing no disease burden and 100 representing the maximum level of disease burden. Subscale scores are also weighted to generate a total NDD-HI score (0-100) representing overall disease burden.