Article type
Abstract
Background: 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 implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic.
Objectives: Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of randomised placebo-controlled surgical trials. Methods: We focus on issues relating to feasibility, participant safety, and design, as well as unanticipated challenges such as a global pandemic.
Results: The key lessons learned were that researchers must proactively involve main stakeholders early in the trial design phase to ascertain feasibility of recruitment, devise clinically appropriate strategies to minimise risks to participant safety, and ensure the trial can be completed successfully. Researchers should also be aware that additional resources are likely to be required for trials of placebo-controlled surgical interventions that are being investigated for the first time. Careful consideration should be given towards enhancing the precision of the placebo and selecting the optimal timing of randomisation relative to intervention delivery. Finally, extensive efforts should be dedicated towards understanding the nuances of the surgical procedure under investigation in order to pinpoint and mitigate opportunities for accidental unblinding or high rates of treatment crossovers – these issues can lead performance bias and possible underestimation of true treatment effects.
Conclusions: Researchers should be aware that additional resources are likely to be required for trials of placebo-controlled surgical interventions. These issues can lead to performance bias and possible underestimation of true treatment effects. Researchers may consider employing and building from the strategies described when designing future placebo-controlled trials of surgical interventions.
Objectives: Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of randomised placebo-controlled surgical trials. Methods: We focus on issues relating to feasibility, participant safety, and design, as well as unanticipated challenges such as a global pandemic.
Results: The key lessons learned were that researchers must proactively involve main stakeholders early in the trial design phase to ascertain feasibility of recruitment, devise clinically appropriate strategies to minimise risks to participant safety, and ensure the trial can be completed successfully. Researchers should also be aware that additional resources are likely to be required for trials of placebo-controlled surgical interventions that are being investigated for the first time. Careful consideration should be given towards enhancing the precision of the placebo and selecting the optimal timing of randomisation relative to intervention delivery. Finally, extensive efforts should be dedicated towards understanding the nuances of the surgical procedure under investigation in order to pinpoint and mitigate opportunities for accidental unblinding or high rates of treatment crossovers – these issues can lead performance bias and possible underestimation of true treatment effects.
Conclusions: Researchers should be aware that additional resources are likely to be required for trials of placebo-controlled surgical interventions. These issues can lead to performance bias and possible underestimation of true treatment effects. Researchers may consider employing and building from the strategies described when designing future placebo-controlled trials of surgical interventions.