Evidence map›Paper›PMID 42380700›Full record

Trial reportAdvances in therapy2026

Usability and Acceptance of Autoinjector and Prefilled Syringe Devices by Patients with Generalized Myasthenia Gravis in a Human Factors Study.

Kelly G Gwathmey, Panru Jing, Scott Laorr, Joe Koo, Sanjay Rakhade, Emmett Alton Sartor, J T Tibung, Jason Murray, Christina Laskar

Abstract readRandomized Controlled TrialValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Kelly G GwathmeyVCU Health, Virginia Commonwealth University, 1101 East Marshall Street, Richmond, VA, 23298, USA. kgg2125@cumc.columbia.edu.ORCID http://orcid.org/0000-0002-7589-8826
Panru JingInsight by Nemera, Chicago, IL, USA.
Scott LaorrInsight by Nemera, Chicago, IL, USA.
Joe KooAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
Sanjay RakhadeAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
Emmett Alton SartorAstraZeneca, Boston, MA, USA.ORCID http://orcid.org/0000-0001-7058-7490
J T TibungAlexion, AstraZeneca Rare Disease, Zurich, Switzerland.
Jason MurrayAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
Christina LaskarAlexion, AstraZeneca Rare Disease, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGeneralized myasthenia gravis (gMG) is a chronic autoimmune disorder that causes muscle weakness. This human factors (HF) validation study aimed to demonstrate that use of a prefilled syringe with needle safety device (PFS-SD) or autoinjector (AI) is safe and effective for patients with gMG, caregivers, and healthcare professionals (HCPs) to administer injectable medication in the intended use environments without preventable use errors.

methodsPatients with gMG, caregivers, and HCPs were randomized to the PFS-SD or AI. No training on either device use was provided. The safety and usability of both devices were assessed using simulated use scenarios, knowledge-based questions, and participant feedback.

resultsThe simulated use scenario was successfully completed by 94% and 96% of participants using the PFS-SD and AI, respectively, while 90% and 87% of participants, respectively, successfully administered their assigned dose. Device acceptability was reported by 93% and 100% of patient participants for the PFS-SD and AI, respectively.

conclusionThis HF validation study demonstrated that the PFS-SD and AI are safe and effective for use by patients with gMG, caregivers, and HCPs in the intended use environments.

Indexed as

Myasthenia GravisSyringesAdultAgedCaregiversFemaleHumansMaleMiddle AgedDrug delivery systemsGeneralized myasthenia gravis, injections, subcutaneousPatient preference

Identifiers

PMID42380700
PMCPMC13499743

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Registered trials

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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.