Skip to content
DraconiticResearch
Search Sources API
203,234 studies31 sourcesUpdated 32 min ago
Peer-reviewedCC BY 4.0Frontiers in Neurology

Psychometric properties of the novel patient-reported Functional Impacts of Narcolepsy Instrument (FINI) using data from phase 3 clinical trials in narcolepsy type 1

  • Heather Romero1
  • Yulia Savva1
  • Stephen Crawford1
  • Amy Howerter2
  • Shruti Dave2
  • Helen Doll2
  1. 1Takeda Development Center Americas, Inc.
  2. 2Clinical Outcomes Solutions
Read full textPDFDOICite

Abstract

Background: The Functional Impacts of Narcolepsy Instrument (FINI) is a 28-item patient-reported outcome measure developed to evaluate key functional impacts in people with narcolepsy type 1 (NT1) and 2 (NT2) across 6 domains: Tiredness, Cognitive Functioning, Cataplexy, Social Activities, Everyday Activities, Everyday Responsibilities. This study aimed to assess the FINI's psychometric properties and estimate meaningful within-patient change (MWPC) thresholds in NT1 using pooled data from 2 phase 3 clinical trials evaluating oveporexton in NT1 ( N = 167, NCT06470828; N = 105, NCT06505031).

Methodology: FINI scale structure, known-groups validity, convergent/divergent validity, internal consistency reliability, test-retest reliability, and responsiveness were evaluated. MWPC thresholds were estimated using anchor- and distribution-based approaches.

Results: Confirmatory factor analysis supported the FINI 6-domain scale structure. The domains demonstrated good known-groups validity, especially for comparisons between severe and moderate reference measure groups (most P -values < 0.05, standardized effect sizes: 0.3–0.9). Convergent/divergent validity was supported by agreement between observed and expected correlation coefficients between FINI domains and reference measures. Most domains demonstrated good internal consistency (Cronbach's alpha: 0.63–0.90; ≥0.78 for all except Everyday Activities). Excellent test-retest reliability was observed for all domains in a subpopulation of participants with a stable condition based on self-reported Patient Global Impression of Severity scores (ICC ≥0.70). Good responsiveness was demonstrated for all FINI domains, supported by correlations between domain and continuous reference measure change scores >0.35, and with greater improvements in domain scores associated with greater categorical improvements in reference measures (all P -values <0.05, average between-group standardized response mean across domains: 0.69). All prespecified anchors exceeded the a priori threshold correlation with FINI domains (≥0.30) and were used to derive MWPC thresholds (ranges): Tiredness and Everyday Activities, −35 (−30 to −40); Cognitive Functioning and Everyday Responsibilities, −30 (−25 to −35); Social Activities, −25 (−20 to −30); and Cataplexy, −20 (−15 to −25).

Conclusions: The FINI is a robust and valid measure assessing meaningful and important key functional impacts for people with narcolepsy. These findings support use of the instrument in clinical trials to evaluate treatment benefit in NT1. Given the FINI's sensitivity to change, it can potentially facilitate treatment decisions and track longitudinal outcomes in clinical practice.

Related

  1. Abnormal brain functional network dynamics in narcolepsy type 1 patients
    F. Xiao, M. Wang, W. Wang +4
    Sleep MedicinePeer-reviewedLicence not statedNeuroscienceHAL
  2. The effectiveness and value of oveporexton for narcolepsy
    Dmitriy Nikitin, Grace A. Lin, Sol Sanchez +4
    Journal of Managed Care & Specialty PharmacyPeer-reviewedLicence not statedFull textNeurosciencePMC
  3. Therapeutic Prospects of Ketamine for Cataplexy in Narcolepsy Type 1: Evidence from a Human Case and a Murine Model
    Francois Ricordeau, Sebastien Arthaud, Leila Langbour +6
    Annals of NeurologyPeer-reviewedCC BYFull textNeuroscienceEpidemiology & public healthHAL
  4. The role of histamine in narcolepsy type 1: a narrative review.
    Wei Liang, Xue Yan, Yanan Zhao +4
    Frontiers in neurologyPeer-reviewedCC BYFull textNeuroscienceEurope PMCCrossref
  5. Orexin deficiency and cardiometabolic risk in narcolepsy: mechanistic pathways and therapeutic implications
    Anant Shukla, Jacqueline H. Geer, Brandon Nokes +1
    FunctionPeer-reviewedCC BY 4.0Full textNeurosciencePMC

Cite

BibTeXRIS
BibTeX
@article{romero2026psychometric,
  title = {{Psychometric properties of the novel patient-reported Functional Impacts of Narcolepsy Instrument (FINI) using data from phase 3 clinical trials in narcolepsy type 1}},
  author = {Heather Romero and Yulia Savva and Stephen Crawford and Amy Howerter and Shruti Dave and Helen Doll},
  journal = {Frontiers in Neurology},
  year = {2026},
  month = oct,
  doi = {10.3389/fneur.2026.1884901},
  url = {https://www.frontiersin.org/articles/10.3389/fneur.2026.1884901/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Psychometric properties of the novel patient-reported Functional Impacts of Narcolepsy Instrument (FINI) using data from phase 3 clinical trials in narcolepsy type 1
AU  - Heather Romero
AU  - Yulia Savva
AU  - Stephen Crawford
AU  - Amy Howerter
AU  - Shruti Dave
AU  - Helen Doll
PY  - 2026
DA  - 2026/10/15
JO  - Frontiers in Neurology
DO  - 10.3389/fneur.2026.1884901
UR  - https://www.frontiersin.org/articles/10.3389/fneur.2026.1884901/full
AB  - Background: The Functional Impacts of Narcolepsy Instrument (FINI) is a 28-item patient-reported outcome measure developed to evaluate key functional impacts in people with narcolepsy type 1 (NT1) and 2 (NT2) across 6 domains: Tiredness, Cognitive Functioning, Cataplexy, Social Activities, Everyday Activities, Everyday Responsibilities. This study aimed to assess the FINI's psychometric properties and estimate meaningful within-patient change (MWPC) thresholds in NT1 using pooled data from 2 phase 3 clinical trials evaluating oveporexton in NT1 ( N = 167, NCT06470828; N = 105, NCT06505031).  Methodology: FINI scale structure, known-groups validity, convergent/divergent validity, internal consistency reliability, test-retest reliability, and responsiveness were evaluated. MWPC thresholds were estimated using anchor- and distribution-based approaches.  Results: Confirmatory factor analysis supported the FINI 6-domain scale structure. The domains demonstrated good known-groups validity, especially for comparisons between severe and moderate reference measure groups (most P -values < 0.05, standardized effect sizes: 0.3–0.9). Convergent/divergent validity was supported by agreement between observed and expected correlation coefficients between FINI domains and reference measures. Most domains demonstrated good internal consistency (Cronbach's alpha: 0.63–0.90; ≥0.78 for all except Everyday Activities). Excellent test-retest reliability was observed for all domains in a subpopulation of participants with a stable condition based on self-reported Patient Global Impression of Severity scores (ICC ≥0.70). Good responsiveness was demonstrated for all FINI domains, supported by correlations between domain and continuous reference measure change scores >0.35, and with greater improvements in domain scores associated with greater categorical improvements in reference measures (all P -values <0.05, average between-group standardized response mean across domains: 0.69). All prespecified anchors exceeded the a priori threshold correlation with FINI domains (≥0.30) and were used to derive MWPC thresholds (ranges): Tiredness and Everyday Activities, −35 (−30 to −40); Cognitive Functioning and Everyday Responsibilities, −30 (−25 to −35); Social Activities, −25 (−20 to −30); and Cataplexy, −20 (−15 to −25).  Conclusions: The FINI is a robust and valid measure assessing meaningful and important key functional impacts for people with narcolepsy. These findings support use of the instrument in clinical trials to evaluate treatment benefit in NT1. Given the FINI's sensitivity to change, it can potentially facilitate treatment decisions and track longitudinal outcomes in clinical practice.
SN  - 1664-2295
ER  -