Evidence map›Paper›PMID 39324505›Full record

SynthesisEpilepsia open2024

User involvement in the design and development of medical devices in epilepsy: A systematic review.

João Ferreira, Ricardo Peixoto, Lígia Lopes, Sándor Beniczky, Philippe Ryvlin, Carlos Conde, João Claro

Abstract readSystematic Review
In one paragraph

Synthesis in Epilepsia open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

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

  1. Pooled it
  2. 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

7 authors.

João FerreiraFaculty of Engineering, University of Porto, Porto, Portugal.ORCID https://orcid.org/0000-0002-5827-0623
Ricardo PeixotoFaculty of Engineering, University of Porto, Porto, Portugal.
Lígia LopesFaculty of Engineering, University of Porto, Porto, Portugal.
Sándor BeniczkyDepartment of Clinical Neurophysiology, Aarhus University Hospital, Aarhus, Denmark.ORCID https://orcid.org/0000-0002-6035-6581
Philippe RyvlinDepartment of Clinical Neurosciences, Lausanne University Hospital, Lausanne, Switzerland.ORCID https://orcid.org/0000-0001-7775-6576
Carlos Condei3S, Instituto de Investigação e Inovação Em Saúde, University of Porto, Porto, Portugal.ORCID https://orcid.org/0000-0002-4177-8519
João ClaroFaculty of Engineering, University of Porto, Porto, Portugal.ORCID https://orcid.org/0000-0001-5936-1036

Funding

European Innovation Council and Small and Medium-sized Enterprises Executive Agency 101047131
6 · The paper itself

Abstract

objectiveThis systematic review aims to describe the involvement of persons with epilepsy (PWE), healthcare professionals (HP) and caregivers (CG) in the design and development of medical devices is epilepsy.

methodsA systematic review was conducted, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligibility criteria included peer-reviewed research focusing on medical devices for epilepsy management, involving users (PWE, CG, and HP) during the MDD process. Searches were performed on PubMed, Web of Science, and Scopus, and a total of 55 relevant articles were identified and reviewed.

resultsFrom 1999 to 2023, there was a gradual increase in the number of publications related to user involvement in epilepsy medical device development (MDD), highlighting the growing interest in this field. The medical devices involved in these studies encompassed a range of seizure detection tools, healthcare information systems, vagus nerve stimulation (VNS) and electroencephalogram (EEG) technologies reflecting the emphasis on seizure detection, prediction, and prevention. PWE and CG were the primary users involved, underscoring the importance of their perspectives. Surveys, usability testing, interviews, and focus groups were the methods used for capturing user perspectives. User involvement occurs in four out of the five stages of MDD, with production being the exception. SIGNIFICANCE: User involvement in the MDD process for epilepsy management is an emerging area of interest holding a significant promise for improving device quality and patient outcomes. This review highlights the need for broader and more effective user involvement, as it currently lags in the development of commercially available medical devices for epilepsy management. Future research should explore the benefits and barriers of user involvement to enhance medical device technologies for epilepsy. PLAIN LANGUAGE SUMMARY: This review covers studies that have involved users in the development process of medical devices for epilepsy. The studies reported here have focused on getting input from people with epilepsy, their caregivers, and healthcare providers. These devices include tools for detecting seizures, stimulating nerves, and tracking brain activity. Most user feedback was gathered through surveys, usability tests, interviews, and focus groups. Users were involved in nearly every stage of device development except production. The review highlights that involving users can improve device quality and patient outcomes, but more effective involvement is needed in commercial device development. Future research should focus on the benefits and challenges of user involvement.

Indexed as

EpilepsyCaregiversElectroencephalographyEquipment and SuppliesEquipment DesignHealth PersonnelHumansPatient ParticipationVagus Nerve Stimulationepilepsymedical device designmedical devicesuser involvement

Identifiers

PMID39324505
PMCPMC11633715

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.