Evidence map›Paper›PMID 30143019›Full record

Observational studyBMC neurology2018

Sleep quality, daytime sleepiness, fatigue, and quality of life in patients with multiple sclerosis treated with interferon beta-1b: results from a prospective observational cohort study.

Sylvia Kotterba, Thomas Neusser, Christiane Norenberg, Patrick Bussfeld, Thomas Glaser, Martin Dörner, Markus Schürks

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01766063 (BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% of its field
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.

NCT01766063 completednot on this map

BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients

TypeobservationalSponsorBayerRan2012 to 2017Enrolled138ConditionsMultiple SclerosisArmsInterferon beta-1b (Betaferon, BAY 86-5046)
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
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  6. Article
  7. Review
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  12. The multidimensional sleep health of individuals with multiple sclerosis and Huntington's disease and healthy controls.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
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  16. Review
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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

7 authors at 2 institutions in 2 countries.

Sylvia KotterbaKlinik für Geriatrie, Klinikum Leer gemeinnützige GmbH, Leer, Germany.
Thomas NeusserBayer Vital GmbH, Leverkusen, Germany.
Christiane NorenbergBayer AG, Wuppertal, Germany.
Patrick BussfeldBayer Consumer Care AG, Basel, Switzerland.
Thomas GlaserBayer Vital GmbH, Leverkusen, Germany.
Martin DörnerBayer Vital GmbH, Leverkusen, Germany.
Markus SchürksBayer Vital GmbH, Leverkusen, Germany. markus.schuerks@bayer.com.ORCID http://orcid.org/0000-0002-0477-8288
Bayer (Germany) · DEBayer (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSleep disorders and fatigue are common in multiple sclerosis (MS). The underlying causes are not fully understood, and prospective studies are lacking. Therefore, we conducted a prospective, observational cohort study investigating sleep quality, fatigue, quality of life, and comorbidities in patients with MS.

methodsPatients with relapsing-remitting MS or clinically isolated syndrome treated with interferon beta-1b were followed over two years. The primary objective was to investigate correlations between sleep quality (PSQI), fatigue (MFIS), and functional health status (SF-36). Secondary objectives were to investigate correlations of sleep quality and daytime sleepiness (ESS), depression (HADS-D), anxiety (HADS-A), pain (HSAL), and restless legs syndrome (RLS). We applied descriptive statistics, correlation and regression analyses.

results139 patients were enrolled, 128 were available for full analysis. The proportion of poor sleepers (PSQI≥5) was 55.47% at the beginning and 37.70% by the end of the study (106 and 41 evaluable questionnaires, respectively). Poor sleepers performed worse in MFIS, SF-36, ESS, HADS-D, and HADS-A scores. The prevalence of patients with RLS was low (4.5%) and all were poor sleepers. Poor sleep quality was positively correlated with fatigue and low functional health status. These relationships were corroborated by multivariable-adjusted regression analyses. ESS values and poor sleep quality at baseline seem to predict sleep quality at the one-year follow-up. No variable predicted sleep quality at the two-year follow-up.

conclusionsOur results confirm the high prevalence of poor sleep quality among patients with MS and its persistent correlation with fatigue and reduced quality of life over time. They highlight the importance of interventions to improve sleep quality.

trial registrationThe study was registered at clinicaltrials.gov: NCT01766063 (registered December 7, 2012). Registered retrospectively (first patient enrolled December 6, 2012).

Indexed as

Adjuvants, ImmunologicAdultAgedCohort StudiesFatigueFemaleHumansInterferon beta-1bMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingPrevalenceProspective StudiesQuality of LifeRetrospective StudiesSleepAdjuvants, ImmunologicInterferon beta-1bFatigueFunctional health statusInterferon beta-1bMultiple sclerosisReal worldSleep quality

Identifiers

PMID30143019
PMCPMC6107945
OpenAlexW2888355898

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.