Bresnahan Rebecca, Copley Sue, Eldabe Sam, Thomson Simon, North Richard B, Baranidharan Ganesan, Levy Robert M, Collins Gary S, Taylor Rod S, Duarte Rui V
Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK.
Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.
EClinicalMedicine. 2024 Nov 12;78:102933. doi: 10.1016/j.eclinm.2024.102933. eCollection 2024 Dec.
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.
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).
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.
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.
Abbott, Boston Scientific Corp., Mainstay Medical, Medtronic Ltd, Nevro Corp., and Saluda Medical.
《标准方案条目：干预性试验推荐规范》（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。植入式神经刺激装置临床试验方案中的方法学和报告缺陷很常见。SPIRIT-iNeurostim扩展是一项用于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。
SPIRIT-iNeurostim是使用EQUATOR方法框架制定的，包括文献综述和专家咨询，以生成候选条目的初始列表。候选条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。
初始扩展条目列表包括42个与SPIRIT-iNeurostim相关的候选条目。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SPIRIT-iNeurostim提出了另外14个候选条目，在共识会议上讨论了那些达成初步共识 的条目。SPIRIT-iNeurostim扩展包括5个新的清单条目，其中一个条目用于报告神经刺激干预，包括一个由14个条目组成的单独清单。
SPIRIT-iNeurostim扩展将有助于提高评估植入式神经刺激装置的试验方案报告的透明度、清晰度和完整性。它将帮助期刊编辑、同行评审人员和读者更好地解释用于计划中的临床试验的方法的适当性和普遍性。
雅培公司、波士顿科学公司、Mainstay Medical公司、美敦力有限公司、Nevro公司和Saluda Medical公司。
