Duarte Rui V, Bresnahan Rebecca, Copley Sue, Eldabe Sam, Thomson Simon, North Richard B, Baranidharan Ganesan, Levy Robert M, Collins Gary S, Taylor Rod S
Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK.
Saluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia.
EClinicalMedicine. 2024 Nov 12;78:102932. doi: 10.1016/j.eclinm.2024.102932. eCollection 2024 Dec.
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.
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).
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.
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.
Abbott, Boston Scientific Corp., Mainstay Medical, Medtronic Ltd, Nevro Corp. and Saluda Medical.
《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，以解决试验报告的特定问题，包括与特定类型干预措施相关的问题。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扩展是一项用于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是使用EQUATOR方法框架制定的，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，在一次国际共识会议（42名利益相关者，包括来自美国、英国、荷兰和其他国家的医疗保健专业人员、方法学家、期刊编辑和行业代表）上进行讨论，并通过清单试点（18名利益相关者）进行完善。
初始扩展项目列表包括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，在第二轮中收到了99份回复。参与者在第一轮调查中为CONSORT-iNeurostim提出了另外20个候选项目，在共识会议上讨论了那些达成初步共识的项目。CONSORT-iNeurostim扩展包括7个新的清单项目，其中一个项目用于报告神经刺激干预措施，包括一个单独的14项清单。
CONSORT-iNeurostim扩展将促进植入式神经刺激设备试验报告的透明度、清晰度和完整性的提高。它将帮助期刊编辑、同行评审人员和读者更好地解释所使用方法的适当性和普遍性以及报告的结果。
雅培、波士顿科学公司、Mainstay Medical、美敦力有限公司、Nevro公司和Saluda Medical。
