脊髓刺激治疗疼痛的随机对照试验设计方案：IMMPACT联盟/神经调制应用研究协会/国际神经调制学会推荐意见共识（摘要）
英语晨读 ·
山东省立医院疼痛科英语晨读已经坚持10余年的时间了，每天交班前15分钟都会精选一篇英文文献进行阅读和翻译。一是可以保持工作后的英语阅读习惯，二是可以学习前沿的疼痛相关知识。我们会将晨读内容与大家分享，助力疼痛学习。
本次文献选自Nathaniel Katz, Robert H Dworkin, Richard North, et al. Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations. Pain,2021;162(7):1935-1956。本次学习由谢珺田副主任医师主讲。
Abstract
Spinal cord stimulation (SCS) is an interventional nonpharmacologic treatment used for chronic pain and other indications. Methods for evaluating the safety and efficacy of SCS have evolved from uncontrolled and retrospective studies to prospective randomized controlled trials (RCTs). Although randomization overcomes certain types of bias, additional challenges to the validity of RCTs of SCS include blinding, choice of control groups, nonspecific effects of treatment variables (eg, paresthesia, device programming and recharging, psychological support, and rehabilitative techniques), and safety considerations. To address these challenges, 3 professional societies (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials, Institute of Neuromodulation, and International Neuromodulation Society) convened a meeting to develop consensus recommendations on the design, conduct, analysis, and interpretation of RCTs of SCS for chronic pain. This article summarizes the results of this meeting. Highlights of our recommendations include disclosing all funding source and potential conflicts; incorporating mechanistic objectives when possible; avoiding noninferiority designs without internal demonstration of assay sensitivity; achieving and documenting double-blinding whenever possible; documenting investigator and site experience; keeping all information provided to patients balanced with respect to expectation of benefit; disclosing all information provided to patients, including verbal scripts; using placebo/sham controls when possible; capturing a complete set of outcome assessments; accounting for ancillary pharmacologic and nonpharmacologic treatments in a clear manner; providing a complete description of intended and actual programming interactions; making a prospective ascertainment of SCS-specific safety outcomes; training patients and researchers on appropriate expectations, outcome assessments, and other key aspects of study performance; and providing transparent and complete reporting of results according to applicable reporting guidelines.
Keywords: Spinal cord stimulation, Medical devices, Randomized controlled trials, Clinical trials, Clinical research methods
摘要
脊髓电刺激（SCS）是一种可用于慢性疼痛和其它适应证的介入性非药物治疗方法。评价SCS安全性和有效性的方法已从非对照和回顾性研究发展为前瞻性随机对照试验（RCT）。尽管随机化能克服某些类型的偏差，但SCS-RCT有效性的影响因素还包括盲法、对照组的选择、治疗参数的非特异性效应（如感觉异常、装置编程和充电、心理支持和康复技术）以及安全性。为了消除这些混杂因素的影响，3个研究机构（临床试验方案设计与治疗参数测定及疼痛评估研究联盟、神经调制应用研究协会和国际神经调制学会）共同召开了一次会议，就SCS慢性疼痛随机对照试验的设计、实施、数据分析和结果解释提出了共识推荐意见。本文总结了这次会议的结果。推荐意见的要点包括披露所有资金来源和潜在利益争议冲突；尽可能采用客观指标；避免未经灵敏度验证分析的非劣效性设计；尽可能实现双盲法并详细记录；记录调查者及其现场体验；保持向患者提供的所有信息与预期收益保持一致；披露向患者提供的所有信息，包括口语版本；尽可能采用安慰剂/假手术对照；获取记录完整的评估结果；明确说明辅助治疗药物和非药物治疗方法；提供预期和实际编程互动的完整描述；对SCS具体化的安全性进行前瞻性评估；就适宜的治疗预期、结果评估和研究完成度的其他关键影响因素对患者和研究人员进行教育培训；并根据适用的报告指南提供透明和完整的结果报告。
关键词：脊髓电刺激，医疗器械，随机对照试验，临床试验，临床研究方法