Evidence map›Paper›PMID 28877664›Full record

Observational studyBMC neurology2017

Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® autoinjector: a prospective observational cohort study.

Ingo Kleiter, Michael Lang, Judith Jeske, Christiane Norenberg, Barbara Stollfuß, Markus Schürks

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

Observational study in BMC neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02121444 (BETAEVAL - The New BETACONNECT® Auto-injector), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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.

NCT02121444 completednot on this map

BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®

TypeobservationalSponsorBayerRan2014 to 2016Enrolled151ConditionsMultiple SclerosisArmsInterferon beta-1b (Betaferon, BAY 86-5046), BETACONNECT auto-injector.
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Autoinjector - A smart device for emergency cum personal therapy.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2021
    Review
  5. Article
  6. Article
  7. Article
  8. Observational
  9. Review
  10. Observational
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 at 3 institutions in 1 country.

Ingo KleiterSt. Josef Hospital, University Hospital Bochum, Bochum, Germany.
Michael LangJoint Neurological Practice, Ulm, Germany.
Judith JeskeNeurological Practice, Wuppertal, Germany.
Christiane NorenbergBayer AG, Wuppertal, Germany.
Barbara StollfußBayer Vital GmbH, Leverkusen, Germany.
Markus SchürksBayer Vital GmbH, Leverkusen, Germany. markus.schuerks@bayer.com.ORCID http://orcid.org/0000-0002-0477-8288
Bayer (Germany) · DEUniversity of Wuppertal · DEZentrum Überleben · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaintaining patient adherence to disease modifying drugs in multiple sclerosis is a challenge, which can be improved by autoinjectors. The BETACONNECT® is a fully electronic autoinjector for the injection of interferon beta-1b (IFN beta-1b) automatically recording injections.

methodsThe BETAEVAL study was a prospective, observational, cohort study over 24 weeks among patients with relapsing remitting multiple sclerosis or clinically isolated syndrome treated with IFN beta-1b in Germany using the BETACONNECT®. The primary aim was to investigate treatment adherence, secondary aims included assessing satisfaction and functional health status. Adherence was evaluated from injection data recorded by the device. Patient-related data were obtained from clinical examinations and patient questionnaires.

resultsOf the 151 patients enrolled, 143 were available for analysis. Thirty-four patients discontinued the study prematurely. 107/143 (74.8%) patients still used the BETACONNECT® at the end of the study. Injection data from the device at any visit was available for 107 patients. Among those, the percentage of adherent patients injecting ≥80% of doses and still participating in the study was 57.9% at week 24. 29% of patients prematurely stopped the study, 13.1% injected <80%. Among patients with BETACONNECT® data at the respective visit, the proportion of adherent patients was high over the entire study period (week 4: 81.1% [N = 95], week 12: 86.7% [N = 83], week 24: 80.5% [N = 77]). Participants (N = 143) indicated high satisfaction with the BETACONNECT®. At week 24, 98.0% of patients who completed the corresponding questionnaire (strongly) agreed that it was user-friendly, 81.2% felt confident in using it compared to their previous way and 85.5% preferred it to their previous way of injection. Injection-related pain was rated as mild to moderate at all follow-up visits. Whereas 17.2% of patients with corresponding questionnaire indicated using analgesics prior to injection at week 4, only 9.1% did at week 24. Outcomes from questionnaires assessing functional health status, depression, fatigue and cognitive function were very similar throughout the study course.

conclusionsThe majority of patients continued using the BETACONNECT® for IFN beta-1b treatment during the 24-week study period. Adherence was high among participants still using the BETACONNECT® and patients were highly satisfied with the device. Ongoing studies will evaluate long-term adherence and treatment outcomes in patients using the BETACONNECT®.

trial registrationclinicaltrails.gov NCT02121444 (registered April 22, 2014).

Indexed as

Medication AdherenceAdultAgedCohort StudiesFemaleGermanyHealth StatusHumansInjections, SubcutaneousInterferon beta-1bMaleMiddle AgedMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingPatient SatisfactionProspective StudiesInterferon beta-1bAdherenceAutoinjectorBETACONNECT®ComplianceDisease modifying drugsInterferon beta-1bMultiple sclerosisPersistenceSatisfaction

Identifiers

PMID28877664
PMCPMC5588619
OpenAlexW2751872438

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.