Evidence map›Paper›PMID 29222625›Full record

ArticleAdvances in therapy2018

Using Patient Feedback to Optimize the Design of a Certolizumab Pegol Electromechanical Self-Injection Device: Insights from Human Factors Studies.

Barbara Domańska, Oliver Stumpp, Steven Poon, Serkan Oray, Irina Mountian, Clovis Pichon

Abstract read
In one paragraph

Article in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

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

  1. Pooled it
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  5. Design Development of the SMARTCLICAdvances in therapy · 2023
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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

6 authors.

Barbara DomańskaUCB Pharma, Slough, UK. barbara.domanska@ucb.com.
Oliver StumppUCB Pharma, Bulle, Switzerland.
Steven PoonUCB Pharma, Slough, UK.
Serkan OrayUCB Pharma, Braine-l'Alleud, Belgium.
Irina MountianUCB Pharma, Brussels, Belgium.
Clovis PichonUCB Pharma, Bulle, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava

methodsHealthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections. Formative participant questionnaire feedback was collected following e-Device prototype handling. Validation HFS (one EU study and one US study) assessed the safe and effective setup and use of the e-Device using 22 predefined critical tasks. Task outcomes were categorized as "failures" if participants did not succeed within three attempts.

resultsTwo hundred eighty-three participants entered formative (163) and validation (120) HFS; 260 participants performed one or more simulated e-Device self-injections. Design changes following formative HFS included alterations to buttons and the graphical user interface screen. All validation HFS participants completed critical tasks necessary for CZP dose delivery, with minimal critical task failures (12 of 572 critical tasks, 2.1%, in the EU study, and 2 of 5310 critical tasks, less than 0.1%, in the US study).

conclusionCZP e-Device development was guided by intended user feedback through HFS, ensuring the final design addressed patients' needs. In both validation studies, participants successfully performed all critical tasks, demonstrating safe and effective e-Device self-injections.

fundingUCB Pharma. Plain language summary available on the journal website.

Indexed as

AdultAgedAntirheumatic AgentsArthritisArthritis, PsoriaticArthritis, RheumatoidCertolizumab PegolCrohn DiseaseEquipment DesignFemaleHumansInjections, SubcutaneousMaleMiddle AgedSpondylitis, AnkylosingTumor Necrosis Factor-alphaAntirheumatic AgentsCertolizumab PegolTumor Necrosis Factor-alphaAnti-tumor necrosis factorBiological disease-modifying antirheumatic drugCertolizumab pegole-DeviceElectromechanical injection deviceHuman factors studiesSelf-injection

Identifiers

PMID29222625
PMCPMC5778191

What OpenQuestion holds

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LicenceCC BY-NC
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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.