Evidence map›Paper›PMID 29808422›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2018

Patient-reported outcome: results of the multicenter German post-market study.

Katrin Hasselbacher, B Hofauer, J T Maurer, C Heiser, A Steffen, J U Sommer

Abstract readClinical Trial, Phase IVMulticenter Study
PubMed Publisher
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Large variability in definitions of sleep apnea indices used in clinical studies.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Pooled it
  2. Referral of adults with obstructive sleep apnea for surgical consultation: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021
    Pooled it
  3. Trial
  4. Article
  5. Use of Hypoglossal Nerve Stimulation for Treating OSA in Military Patient Populations.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2024
    Review
  6. International Consensus Statement on Obstructive Sleep Apnea.International forum of allergy & rhinology · 2023
    Review
  7. Article
  8. Home sleep apnea testing with peripheral arterial tonometry to assess outcome in upper airway stimulation.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Article
  9. Article
  10. Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in Spain: Implementation Strategy and Early Results in a Tertiary Care Center.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2022
    Article
  11. Hypoglossal nerve stimulation for obstructive sleep apnea: updated position paper of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022
    Review
  12. 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

6 authors.

Katrin HasselbacherDepartment of Otorhinolaryngology, University of Lübeck, Ratzeburger Allee, 23538, Lübeck, Germany. Katrin.Hasselbacher@uksh.de.ORCID http://orcid.org/0000-0001-6086-436X
B HofauerDepartment of Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Munich, Germany.
J T MaurerDepartment of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany.
C HeiserDepartment of Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Munich, Germany.
A SteffenDepartment of Otorhinolaryngology, University of Lübeck, Ratzeburger Allee, 23538, Lübeck, Germany.
J U SommerDepartment of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeUpper airway stimulation (UAS) is an alternative second-line treatment option for patients with obstructive sleep apnea (OSA). In our substudy of a previous multicentre study of patients implanted with UAS, we focused on patient-related outcomes like Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), snoring and personal satisfaction 6 and 12 months after the implantation.

methods60 patients, who were initially non-adherent to CPAP and implanted with UAS, were included in a prospective multicentre study. Data were collected preoperative, 6 and 12 months after implantation regarding FOSQ, ESS, snoring, and their experience with the UAS device.

resultsBesides relevant Apnoea-Hypopnea Index (AHI) reduction, we saw significant improvements in ESS (p < 0.001), FOSQ (p < 0.001) and snoring under UAS therapy. A strong correlation between AHI results postoperative and the personal satisfaction of the patients after implantation was found as well as between usage results and AHI compared to the preoperative results.

conclusionThe more the patients benefit from UAS according to their self-reported outcome, the higher is the therapy use.

Indexed as

AdultElectric Stimulation TherapyFemaleGermanyHumansLarynxMaleMiddle AgedPatient Reported Outcome MeasuresPatient SatisfactionProduct Surveillance, PostmarketingProspective StudiesSelf ReportSleep Apnea, ObstructiveSnoringSurveys and QuestionnairesCPAP failureObstructive sleep apnea (OSA)Upper airway stimulation (UAS)

Identifiers

What OpenQuestion holds

Textmetadata
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.