The British journal of surgery
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As COVID-19 outbreak enters its second phase of lockdown ease, healthcare plans involve elective surgery re-establishment to provide essential life-saving care. Patients are increasingly requesting information about their facility's readiness for safely performing surgery. This information should be open and transparent including patient's education with objective data regarding the state of the pandemic in the country and the control measures undertaken by the facility.
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Placebo-controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In-depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs. ⋯ DITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.