Abstract
BackgroundPlacebo‐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.MethodsA preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions; and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics.ResultsThe resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co‐interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel.ConclusionDITTO 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.
Highlights
Randomized controlled trials (RCTs) involving placebo comparators have an important role in the evaluation of healthcare interventions
Development of the framework was informed by the following steps: expanding the scope of the typology[10] to facilitate deconstruction of invasive treatment interventions where access to the body is made via incision, natural orifice and percutaneous puncture; identification of placebo optimization strategies from the published literature; review of a preliminary framework by key stakeholders attending an international expert meeting; and refinement of the framework in light of stakeholder feedback
The DITTO framework can be used in the design and delivery of placebo-controlled trials of invasive interventions, including surgery, to support the generation of the ‘gold standard’ evidence that is needed to underpin delivery of these common healthcare interventions[29]
Summary
Randomized controlled trials (RCTs) involving placebo comparators have an important role in the evaluation of healthcare interventions. Placebo-controlled RCTs provide the methodological ideal in terms of blinding of patients, trial personnel and healthcare professionals to trial group allocation, thereby minimizing the potential for bias. Placebo-controlled trials play an important role in the evaluation of healthcare interventions They can be challenging to design and deliver for invasive interventions, including surgery. Results: The resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co-interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel. Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions
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