Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression.
Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression.
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DOI：
10.1186/s13063-023-07772-5
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发表时间：
2023-12-06
期刊：
影响因子：
2.5
通讯作者：
Ferreira, Manuela Loureiro
中科院分区：
文献类型：
--
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
虽然安慰剂对照试验被认为是评估医疗干预措施疗效的金标准，但对于手术治疗而言，这些试验可能存在争议和挑战。SUcceSS试验是第一项关于腰椎减压手术治疗症状性腰椎管狭窄症的安慰剂对照试验。SUcceSS试验经历了影响随机安慰剂对照手术试验实施的常见问题，并因COVID-19大流行而加剧。以SUcceSS试验为例，我们讨论了进行随机安慰剂对照手术试验的关键挑战和缓解策略。总的来说，所吸取的关键经验教训是（i）在试验设计阶段的早期和整个过程中让关键利益相关者参与可能会增加临床医生和患者参与安慰剂对照手术干预试验的意愿，（ii）额外的资源（例如预算、工作人员时间）可能需要成功实施这种性质的试验，（iii）安慰剂的保真度水平，应仔细考虑相对于干预实施的随机化时间以及研究中外科手术的细微差别。研究结果是基于一个安慰剂对照手术试验的例子;然而，研究人员可能会受益于使用或建设所描述的策略和经验教训时，设计或实施这种性质的未来试验。
Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature.
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DOI：
10.1136/bmj.g3253
发表时间：
2014-05-21
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Wartolowska K;Judge A;Hopewell S;Collins GS;Dean BJ;Rombach I;Brindley D;Savulescu J;Beard DJ;Carr AJ
通讯作者：
Carr AJ
影响因子：
3
作者：
Lurie JD;Tosteson TD;Tosteson AN;Zhao W;Morgan TS;Abdu WA;Herkowitz H;Weinstein JN
通讯作者：
Weinstein JN
影响因子：
2
作者：
Wong, Albert P.;Shih, Patrick;Fessler, Richard G.
通讯作者：
Fessler, Richard G.
影响因子：
5.3
作者：
Deyo, Richard A.;Martin, Brook I.;Mirza, Sohail K.
通讯作者：
Mirza, Sohail K.
影响因子：
--
作者：
Staley, Kristina
通讯作者：
Staley, Kristina