Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension
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Le résumé fourni par la source
Background: The Consolidated Standards of Reporting Trials (CONSORT) statement has improved the quality of reporting of randomised trials. Extensions to the CONSORT statement are often needed to address specific issues of trial reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in clinical trials of implantable neurostimulation devices are common. The CONSORT-iNeurostim extension is a new reporting guideline for randomised controlled trials evaluating implantable neurostimulation devices. Methods: CONSORT-iNeurostim was developed using the EQUATOR methodological framework including a literature review and expert consultation to generate an initial list of candidate items. The candidate items were included in a two-round Delphi survey, discussed at an international consensus meeting (42 stakeholders including healthcare professionals, methodologists, journal editors and industry representatives from the United States, United Kingdom, Netherlands and other countries), and refined through a checklist pilot (18 stakeholders). Findings: The initial extension item list included 49 candidate items relevant to CONSORT-iNeurostim. We received 132 responses in the first round of the Delphi survey and 99 responses in the second round. Participants suggested an additional 20 candidate items for CONSORT-iNeurostim during the first round of the survey, and those achieving initial consensus were discussed at the consensus meeting. The CONSORT-iNeurostim extension includes 7 new checklist items, including one item for reporting the neurostimulation intervention comprising a separate checklist of 14 items. Interpretation: The CONSORT-iNeurostim extension will promote increased transparency, clarity, and completeness of trial reports of implantable neurostimulation devices. It will assist journal editors, peer-reviewers, and readers to better interpret the appropriateness and generalisability of the methods used and reported outcomes. Funding: Abbott, Boston Scientific Corp., Mainstay Medical, Medtronic Ltd, Nevro Corp. and Saluda Medical.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension
- Date Crossref
- 01/12/2024
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Liverpool Liverpool Reviews and Implementation Group pays non établi dans la noticeUniversité ou école supérieure
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Saluda Medical (Australia) pays non établi dans la noticeEntreprise
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James Cook University Hospital Department of Pain Medicine pays non établi dans la noticeÉtablissement de santé
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Essex Cardiothoracic Centre pays non établi dans la noticeÉtablissement de santé
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Basildon Hospital pays non établi dans la noticeÉtablissement de santé
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Johns Hopkins University Anesthesiology and Critical Care Medicine (ret.) pays non établi dans la noticeUniversité ou école supérieure
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Johns Hopkins Medicine pays non établi dans la noticeÉtablissement de santé
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Leeds Teaching Hospitals NHS Trust Leeds Neuromodulation Centre pays non établi dans la noticeÉtablissement de santé
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International Neuromodulation Society pays non établi dans la noticeOrganisation à but non lucratif
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University of Oxford Centre for Statistics in Medicine pays non établi dans la noticeUniversité ou école supérieure
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MRC/CSO Social and Public Health Sciences Unit pays non établi dans la noticeStructure de recherche
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University of Glasgow Institute of Health and Well Being pays non établi dans la noticeUniversité ou école supérieure
Liverpool Reviews and Implementation Group — University of Liverpool, Saluda Medical (Australia) et Department of Pain Medicine — James Cook University Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.