State-of-the-art workshop: Methods for placebo comparator group selection and use in surgical trials

最先进的研讨会：手术试验中安慰剂对照组选择和使用的方法

• 批准号: MC_PC_17155
• 负责人: David Beard
• 金额: $ 3.15万
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Intramural
• 财政年份: 2018
• 资助国家: 英国
• 起止时间: 2018 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MC_PC_17155
• 关键词: State; art; workshop; Methods; placebo

A workshop will develop guidance to inform the future design of surgical trials, specifically the optimal use of placebos.Using a placebo control or comparator is often thought as the “best” trial design to investigate healthcare interventions. A placebo reduces several biases which otherwise undermine a comparative study’s validity. Placebo controlled trials in surgery are highly controversial for ethical and design reasons. The construction of a placebo surgical intervention, the achievement of satisfactory participation/acceptance by surgeons and other key personnel (e.g. anaesthetists) and interpretation of the trial can all be challenging.It is crucial that trialists, patients and surgeons understand the circumstances in which a surgical placebo control a) could or should be used and b) if so, what type of placebo control would be appropriate. There is a need for clear guidance to aid trialists, funders, patients, journal editors and regulators. We will address this knowledge gap.We propose to bring together leading national and international experts to produce state of the art thinking and knowledge on placebo control in surgical evaluation.

研讨会将制定指导，为未来的手术试验设计提供信息，特别是安慰剂的最佳使用。使用安慰剂对照或比较通常被认为是研究医疗干预措施的“最佳”试验设计。安慰剂减少了一些偏差，否则这些偏差会破坏比较研究的有效性。由于伦理和设计原因，手术中的安慰剂对照试验极具争议。安慰剂手术干预的构建、外科医生和其他关键人员（例如麻醉师）的满意参与/接受以及对试验的解释都可能具有挑战性。至关重要的是，试验者、患者和外科医生了解a）可以或应该使用手术安慰剂对照的情况，以及B）如果是，什么类型的安慰剂对照是合适的。需要明确的指导来帮助试验者、资助者、患者、期刊编辑和监管机构。我们将解决这一知识缺口，我们建议汇集国内和国际领先的专家，以产生关于手术评价中安慰剂对照的最新思想和知识。

项目成果

Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression.

• DOI: 10.1186/s13063-023-07772-5
• 发表时间: 2023-12-06
• 期刊: TRIALS
• 影响因子: 2.5
• 作者: Ho, Emma Kwan-Yee;Mobbs, Ralph Jasper;van Gelder, James Montague;Harris, Ian Andrew;Davis, Gavin;Stanford, Ralph;Beard, David John;Maher, Christopher Gerard;Prior, Joanna;Knox, Michael;Anderson, David Barrett;Buchbinder, Rachelle;Ferreira, Manuela Loureiro
• 通讯作者: Ferreira, Manuela Loureiro

Further considerations for placebo controls in surgical trials.

• DOI: 10.1186/s13063-023-07417-7
• 发表时间: 2023-06-10
• 期刊: Trials
• 影响因子: 2.5