Reporting guidelines for protocols of randomised controlled trials of implantable neurostimulation devices: the SPIRIT-iNeurostim extension.

IF 10 1区医学 Q1 MEDICINE, GENERAL & INTERNAL EClinicalMedicine Pub Date : 2024-11-12 eCollection Date: 2024-12-01 DOI:10.1016/j.eclinm.2024.102933

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

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Abstract

Background: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement has improved the quality of reporting of randomised trial protocols. Extensions to the SPIRIT statement are needed to address specific issues of trial protocol reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in protocols of clinical trials of implantable neurostimulation devices are common. The SPIRIT-iNeurostim extension is a new reporting guideline for randomised controlled trial protocols evaluating implantable neurostimulation devices.

Methods: SPIRIT-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 42 candidate items relevant to SPIRIT-iNeurostim. We received 132 responses in the first round of the Delphi survey and 99 responses in the second round. Participants suggested an additional 14 candidate items for SPIRIT-iNeurostim during the first round of the survey, and those achieving initial consensus were discussed at the consensus meeting. The SPIRIT-iNeurostim extension includes 5 new checklist items, including one item for reporting the neurostimulation intervention comprising a separate checklist of 14 items.

Interpretation: The SPIRIT-iNeurostim extension will help to promote increased transparency, clarity, and completeness of reporting trial protocols evaluating implantable neurostimulation devices. It will assist journal editors, peer-reviewers, and readers to better interpret the appropriateness and generalisability of the methods used for a planned clinical trial.

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的随机对照试验方案报告指南：SPIRIT-iNeurostim扩展。

背景：标准方案项目：介入性试验建议（SPIRIT）声明提高了随机试验方案报告的质量。需要对SPIRIT声明进行扩展，以解决试验方案报告的具体问题，包括与特定类型干预措施有关的问题。植入式神经刺激装置临床试验的方法学和报告缺陷是常见的。SPIRIT-iNeurostim扩展是评估植入式神经刺激装置的随机对照试验方案的新报告指南。方法：采用EQUATOR方法框架开发SPIRIT-iNeurostim，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（来自美国、英国、荷兰和其他国家的42名利益相关者，包括卫生保健专业人员、方法学家、期刊编辑和行业代表），并通过清单试点（18名利益相关者）进行完善。结果：最初的扩展项目列表包括42个与SPIRIT-iNeurostim相关的候选项目。我们在第一轮德尔菲调查中收到132份回复，在第二轮中收到99份回复。在第一轮调查中，与会者建议增加14个“SPIRIT-iNeurostim”候选项目，并在协商一致会议上讨论达成初步共识的项目。SPIRIT-iNeurostim扩展包括5个新的检查表项目，其中一个项目用于报告神经刺激干预，包括一个单独的14个项目的检查表。解释：SPIRIT-iNeurostim扩展将有助于提高评估植入式神经刺激装置的报告试验方案的透明度、清晰度和完整性。它将帮助期刊编辑、同行审稿人和读者更好地解释用于计划临床试验的方法的适当性和普遍性。资金来源：雅培、波士顿科学公司、中流医疗、美敦力有限公司、nevo公司和Saluda医疗。

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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.