Evidence map›Paper›PMID 34823566›Full record

ArticleTrials2021

Design, implementation, and management of an international medical device registry.

Herbert Mauch, Jasmin Kaur, Colin Irwin, Josie Wyss

Registry-linked trialAbstract read
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02004353 (Cochlear-Implanted Recipient Observational Study), 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
–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.

NCT02004353 terminatednot on this map

Cochlear-Implanted Recipient Observational Study

Typeobservational_patient_registrySponsorCochlearRan2011 to 2020Enrolled1,518ConditionsHearing LossArmsCochlear® Hearing Implants
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

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

4 authors.

Herbert MauchCochlear AG, Basel, Switzerland. hmauch@cochlear.com.ORCID http://orcid.org/0000-0002-0186-7859
Jasmin KaurCochlear AG, Basel, Switzerland.
Colin IrwinCochlear France SAS, Toulouse, France.
Josie WyssCochlear Ltd., Sydney, Australia.

Funding

cochlear N/A
6 · The paper itself

Abstract

backgroundRegistries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success.

methodsWe summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants.

resultsWe enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in design and implementation and make recommendations for future registries.

conclusionsData collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine.

trial registrationClinicalTrials.gov NCT02004353. 9

Indexed as

Data AccuracyHearing LossHumansProstheses and ImplantsRegistriesSurveys and QuestionnairesCochlear implantInternational registryIROSMedical deviceQuality of lifeSSQ

Identifiers

PMID34823566
PMCPMC8613936

What OpenQuestion holds

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LicenceCC BY
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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.