Evidence map›Paper›PMID 38468601›Full record

ArticleCPT: pharmacometrics & systems pharmacology2024

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

Gustaf J Wellhagen, Mats O Karlsson, Maria C Kjellsson, Dirk Garmann, Astrid Bröker, Yang Zhang, Mika Nokela, Gerrit Weimann, Ashraf Yassen

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Gustaf J WellhagenDepartment of Pharmacy, Uppsala University, Uppsala, Sweden.ORCID 0000-0002-7228-0422
Mats O KarlssonDepartment of Pharmacy, Uppsala University, Uppsala, Sweden.ORCID 0000-0003-1258-8297
Maria C KjellssonDepartment of Pharmacy, Uppsala University, Uppsala, Sweden.ORCID 0000-0003-3531-9452
Dirk GarmannBayer AG, Wuppertal, Germany.
Astrid BrökerBayer AG, Wuppertal, Germany.
Yang ZhangBayer AG, Wuppertal, Germany.
Mika NokelaBayer AG, Wuppertal, Germany.ORCID 0000-0001-6955-6339
Gerrit WeimannBayer AG, Wuppertal, Germany.ORCID 0000-0002-1191-5236
Ashraf YassenBayer AG, Wuppertal, Germany.

Funding

National Sleep Research Resource (NSRR)R24HL114473 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI REDLINE, SUSAN S., ZHANG, GUO-QIANG · 2013 to 2017
$7.5M
DATA COORDINATING CENTER FOR SLEEP HEART STUDYU01HL064360 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI DIENER-WEST, MARIE · 1999 to 2007
$4.4M
THE SLEEP HEART HEALTH STUDY: READING CENTER APPLICATIONU01HL063463 · NHLBI · CASE WESTERN RESERVE UNIVERSITY · PI REDLINE, SUSAN S. · 1999 to 2007
$2.8M
The Sleep Heart Health Study (SHHS)U01HL053938 · NHLBI · UNIVERSITY OF ARIZONA · PI QUAN, STUART F. · 1994 to 2007
$2.0M
SLEEP HEART HEALTH STUDYU01HL053931 · NHLBI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI RAPOPORT, DAVID M. · 1994 to 2003
$1.9M
THE SLEEP HEART HEALTH STUDYU01HL053937 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI PUNJABI, NARESH · 1994 to 2007
$1.6M
SLEEP HEART HEALTH STUDYU01HL053916 · NHLBI · UNIVERSITY OF CALIFORNIA DAVIS · PI ROBBINS, JOHN A · 1994 to 2007
$1.5M
THE SLEEP HEART HEALTH STUDYU01HL053934 · NHLBI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI SHAHAR, EYAL · 1994 to 2007
$1.4M
SLEEP HEART HEALTH STUDYU01HL053941 · NHLBI · BOSTON UNIVERSITY MEDICAL CAMPUS · PI O'CONNOR, GEORGE T · 1994 to 2007
$1.4M
NHLBI NIH HHS R24 HL114473NHLBI NIH HHS U01 HL053916NHLBI NIH HHS U01 HL053931NHLBI NIH HHS U01 HL053934NHLBI NIH HHS U01 HL053937NHLBI NIH HHS U01 HL053938NHLBI NIH HHS U01 HL053941NHLBI NIH HHS U01 HL063463NHLBI NIH HHS U01 HL064360
6 · The paper itself

Abstract

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.

Indexed as

Sleep Apnea, ObstructiveAdultAgedDisorders of Excessive SomnolenceFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresQuality of LifeSeverity of Illness IndexSleepiness

Identifiers

PMID38468601
PMCPMC11098155

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.