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Review
. 2024 Nov 12:78:102932.
doi: 10.1016/j.eclinm.2024.102932. eCollection 2024 Dec.

Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension

Rui V Duarte  1   2 , Rebecca Bresnahan  1 , Sue Copley  3 , Sam Eldabe  3 , Simon Thomson  4 , Richard B North  5 , Ganesan Baranidharan  6 , Robert M Levy  7 , Gary S Collins  8   9 , Rod S Taylor  10
Affiliations
Review

Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension

Rui V Duarte et al. EClinicalMedicine. .

Abstract

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.

Keywords: Clinical trials; Consensus statement; Delphi survey; Neurostimulation; Reporting guidelines.

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Conflict of interest statement

RVD reports consultancy fees from Mainstay Medical, Medtronic Ltd and Saluda Medical outside the submitted work. He is an employee of Saluda Medical; the employer had no role in the submitted work besides its contribution as a stakeholder. SE reports consultancy fees from Mainstay Medical, Medtronic Ltd, and Saluda Medical outside the submitted work. He has received Department Research funding from Saluda Medical, and Boston Scientific. ST reports consultancy fees from Boston Scientific Corp, Mainstay Medical and Saluda Medical outside the submitted work. He has received department research funding from the National Institute of Health Research. RBN serves as an unpaid officer of the nonprofit Neuromodulation Foundation, Inc., to which grants and support have been provided by Abbott, Boston Scientific Corp, Medtronic Ltd, Nevro Corp, Nuvectra, and Stimwave Inc outside the submitted work. He receives royalties from Abbott. GB has a consulting agreement with Nevro Corp, Mainstay Medical, Boston Scientific and Abbott. He has received department research funding from Mainstay Medical and Saluda Medical. RML is an uncompensated consultant for Biotronik, Abbott, Nalu, and Saluda Medical, and has stock options from Nalu and Saluda Medical. RST reports consultancy fees from Medtronic Ltd, Nevro Corp and Saluda Medical outside the submitted work. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT 2010 flow diagram—adapted for clinical trials that compare two different implantable neurostimulation interventions (a CONSORT 2010 flow diagram—adapted for clinical trials that compare an implantable neurostimulation intervention to an alternative non-neurostimulation intervention is presented in Supplementary Material 6). IQR, interquartile range; max, maximum; min, minimum.
See this image and copyright information in PMC

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