Item response theory analysis of daytime sleepiness as a symptom of obstructive sleep apnea.


Journal

CPT: pharmacometrics & systems pharmacology
ISSN: 2163-8306
Titre abrégé: CPT Pharmacometrics Syst Pharmacol
Pays: United States
ID NLM: 101580011

Informations de publication

Date de publication:
12 Mar 2024
Historique:
revised: 18 02 2024
received: 08 11 2023
accepted: 22 02 2024
medline: 12 3 2024
pubmed: 12 3 2024
entrez: 12 3 2024
Statut: aheadofprint

Résumé

Obstructive sleep apnea (OSA) is a sleep disorder which is linked to many health risks. The gold standard to evaluate OSA in clinical trials is the Apnea-Hypopnea Index (AHI). However, it is time-consuming, costly, and disregards aspects such as quality of life. Therefore, it is of interest to use patient-reported outcomes like the Epworth Sleepiness Scale (ESS), which measures daytime sleepiness, as surrogate end points. We investigate the link between AHI and ESS, via item response theory (IRT) modeling. Through the developed IRT model it was identified that AHI and ESS are not correlated to any high degree and probably not measuring the same sleepiness construct. No covariate relationships of clinical relevance were found. This suggests that ESS is a poor choice as an end point for clinical development if treatment is targeted at improving AHI, and especially so in a mild OSA patient group.

Identifiants

pubmed: 38468601
doi: 10.1002/psp4.13125
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

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Auteurs

Gustaf J Wellhagen (GJ)

Department of Pharmacy, Uppsala University, Uppsala, Sweden.

Mats O Karlsson (MO)

Department of Pharmacy, Uppsala University, Uppsala, Sweden.

Maria C Kjellsson (MC)

Department of Pharmacy, Uppsala University, Uppsala, Sweden.

Dirk Garmann (D)

Bayer AG, Wuppertal, Germany.

Astrid Bröker (A)

Bayer AG, Wuppertal, Germany.

Yang Zhang (Y)

Bayer AG, Wuppertal, Germany.

Mika Nokela (M)

Bayer AG, Wuppertal, Germany.

Gerrit Weimann (G)

Bayer AG, Wuppertal, Germany.
Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.

Ashraf Yassen (A)

Bayer AG, Wuppertal, Germany.

Classifications MeSH