Evidence map›Paper›PMID 26082667›Full record

ArticleMedical devices (Auckland, N.Z.)2015

Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population.

Jakob Lange, Philipp Richard, Nick Bradley

Abstract read
In one paragraph

Article in Medical devices (Auckland, N.Z.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Autoinjector - A smart device for emergency cum personal therapy.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2021
    Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. 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

3 authors.

Jakob LangeYpsomed AG, Burgdorf, Switzerland.
Philipp RichardYpsomed AG, Burgdorf, Switzerland.
Nick BradleyBERGO UK, Bearsden, Glasgow, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This article presents a late-stage formative usability study of an autoinjector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. Previous usability work on autoinjectors reported in the literature has been specific to single indications. This study was instead conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to evaluate whether users could use the devices safely and effectively, and could understand the instructions for use (IFU) as well as the accompanying training. Further objectives were to capture any usability issues and to obtain participants' subjective ratings on the IFU and training as well as the confidence and comfort in using the device. A total of 43 participants in 5 groups received training and performed simulated injections either into an injection pad or a mannequin. All participants were able to successfully use the device. The device was well appreciated by all users, with a reported degree of confidence in using the device of 98%, of user comfort of 93%, and of comprehensibility of IFU and training of 98%. These values are higher than other comparable results reported in the literature. The presence of both audible and visible feedback during injection was seen to be a significant factor contributing to injection success. The observation that the device can be safely and efficiently used by all tested user groups provides confidence that the device and IFU in their current form will pass future summative testing in specific applications.

Indexed as

autoinjectorhandling studyhuman factors engineeringinstructions for useuse errorYpsoMate™

Identifiers

PMID26082667
PMCPMC4461121

What OpenQuestion holds

Textmetadata
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.