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

IF 9.6 1区医学 Q1 MEDICINE, GENERAL & INTERNAL EClinicalMedicine Pub Date : 2024-11-12 eCollection Date: 2024-12-01 DOI:10.1016/j.eclinm.2024.102932

Rui V Duarte, Rebecca Bresnahan, Sue Copley, Sam Eldabe, Simon Thomson, Richard B North, Ganesan Baranidharan, Robert M Levy, Gary S Collins, Rod S Taylor

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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.

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植入式神经刺激装置随机对照试验报告指南：CONSORT-iNeurostim 扩展版。

背景：试验报告统一标准（CONSORT）声明提高了随机试验报告的质量。通常需要对 CONSORT 声明进行扩展，以解决试验报告中的具体问题，包括与特定类型干预相关的问题。在植入式神经刺激设备的临床试验中，方法学和报告方面的缺陷很常见。CONSORT-iNeurostim 扩展版是评估植入式神经刺激设备的随机对照试验的新报告指南：CONSORT-iNeurostim 采用 EQUATOR 方法框架开发，包括文献综述和专家咨询，以生成候选项目的初始列表。候选项目被纳入两轮德尔菲调查，在国际共识会议上进行讨论（42 位利益相关者，包括来自美国、英国、荷兰和其他国家的医疗保健专业人士、方法论专家、期刊编辑和行业代表），并通过核对表试点（18 位利益相关者）进行完善：最初的扩展项目清单包括 49 个与 CONSORT-iNeurostim 相关的候选项目。我们在第一轮德尔菲调查中收到了 132 份回复，在第二轮调查中收到了 99 份回复。在第一轮调查中，参与者又为 CONSORT-iNeurostim 提出了 20 个候选条目，并在共识会议上对达成初步共识的条目进行了讨论。CONSORT-iNeurostim 扩展版包括 7 个新的核对表条目，其中一个条目用于报告神经刺激干预，由 14 个条目组成一个单独的核对表：CONSORT-iNeurostim 扩展版将提高植入式神经刺激设备试验报告的透明度、清晰度和完整性。它将帮助期刊编辑、同行评审员和读者更好地解释所用方法和报告结果的适当性和可推广性：雅培、波士顿科学公司、Mainstay Medical、美敦力有限公司、Nevro Corp.

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来源期刊

EClinicalMedicine Medicine-Medicine (all)

CiteScore

18.90

自引率

1.30%

发文量

506

审稿时长

22 days

期刊介绍： eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.