Evidence map›Paper›PMID 34862297›Full record

ArticleBMJ open2021

TELEmedicine for EPIlepsy Care (TELE-EPIC): protocol of a randomised, open controlled non-inferiority clinical trial.

Laura Licchetta, Marina Trivisano, Elisa Baldin, Susan Mohamed, Emanuel Raschi, Barbara Mostacci, Corrado Zenesini, Manuela Contin, Federico Vigevano, Francesca Bisulli and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04496310 (Telemedicine With Mobile Internet Devices for Innovative Care of Patients With Epilepsy), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

NCT04496310 naunknown statusnot on this map

Telemedicine With Mobile Internet Devices for Innovative Care of Patients With Epilepsy

TypeinterventionalSponsorAzienda Usl di BolognaRan2020 to 2023Enrolled600ConditionsEpilepsy, Epileptic Encephalopathy, Refractory EpilepsyArmsTelemedicine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
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

12 authors at 3 institutions in 1 country.

Laura LicchettaIRCCS, Instituto delle Scienze Neurologiche di Bologna, Full Member of European Reference Network EpiCARE, Bologna, Italy laura.licchetta@ausl.bo.it.ORCID 0000-0001-7979-9895
Marina TrivisanoDepartment of Neuroscience, Rare and Complex Epilepsies Unit, Bambino Gesù Children's Hospital, IRCCS, Full Member of European Reference Network EpiCARE, Rome, Italy.
Elisa BaldinEpidemiology and Statistics Unit, IRCCS, Instituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Susan MohamedIRCCS, Instituto delle Scienze Neurologiche di Bologna, Full Member of European Reference Network EpiCARE, Bologna, Italy.
Emanuel RaschiDepartment of Medical and Surgical Sciences, Pharmacology Unit, University of Bologna, Bologna, Italy.ORCID 0000-0003-0487-7996
Barbara MostacciIRCCS, Instituto delle Scienze Neurologiche di Bologna, Full Member of European Reference Network EpiCARE, Bologna, Italy.
Corrado ZenesiniEpidemiology and Statistics Unit, IRCCS, Instituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Manuela ContinIRCCS, Instituto delle Scienze Neurologiche di Bologna, Full Member of European Reference Network EpiCARE, Bologna, Italy.
Federico VigevanoDepartment of Neuroscience, Rare and Complex Epilepsies Unit, Bambino Gesù Children's Hospital, IRCCS, Full Member of European Reference Network EpiCARE, Rome, Italy.
Francesca BisulliIRCCS, Instituto delle Scienze Neurologiche di Bologna, Full Member of European Reference Network EpiCARE, Bologna, Italy.
Paolo TinuperIRCCS, Instituto delle Scienze Neurologiche di Bologna, Full Member of European Reference Network EpiCARE, Bologna, Italy.
Luca VignatelliEpidemiology and Statistics Unit, IRCCS, Instituto delle Scienze Neurologiche di Bologna, Bologna, Italy.ORCID 0000-0002-9051-7091
Istituto delle Scienze Neurologiche di Bologna · ITBambino Gesù Children's Hospital · ITUniversity of Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEpilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS). METHODS AND ANALYSIS: TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device. ETHICS AND DISSEMINATION: The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project's webpage on ClinicalTrials.gov. The project's results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts. TRIAL REGISTRATION NUMBER: NCT04496310.

Indexed as

EpilepsyTelemedicineAdultChildEquivalence Trials as TopicHumansMulticenter Studies as TopicOutpatientsPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicSeizuresCOVID-19epilepsytelemedicine

Identifiers

PMID34862297
PMCPMC8646970
OpenAlexW3216969251

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.