Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this paper is to provide a summary of current knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group and, although powerful, presents many challenges in a surgical setting. This review outlines what a placebosurgical control entails and our understanding of the placebo phenomenon in the context of surgery. It considers when placebo-surgical controls are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo-surgical control should be designed, how to identify and mitigate risk for participants in placebo surgical trials, how such trials should be conducted and interpreted. Use of placebo control is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos may be most appropriate where there is poor evidence on the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly due to the placebo effect. Feasibility work is recommended to optimise RCT design and conduct. This review forms an outline for best practice and provides guidance, in the form of the ASPIRE (Applying Surgical Placebo in Randomised Evaluations) checklist, for those considering the use of a placebo-control in a surgical randomised controlled trial.

Background

Despite increasing attention given to dementia by international governments and policy makers, the focus of end of life care has been on the dying trajectory of malignant disease. People with severe dementia have complex physical and psychological needs, yet the disease is not always recognised as terminal. Advance Care Planning involving people with dementia and their families can provide opportunities to discuss and later, initiate timely palliative care.We conducted a scoping review of studies exploring decisions associated with the EoLC of people with dementia. Eligible studies had to report on decision making at the end of life and by whom (the dying person, clinician/health professional or relative/family member).Twenty-five eligible studies reported on Advance Care Planning and end of life care decisions for individuals with dementia. The papers highlight several challenges that need to be addressed in order to provide adequate and effective care for people with dementia as they near the end of their life.

BackgroundThis paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds.MethodsThe consensus process used a modified Delphi approach.ResultsConsensus was reached on 15 standards of practice, organised into 6 domains of research practice (Aims, Questions, Integration, Conduct of Empirical Work, Conduct of Normative Work; Training & Expertise).ConclusionsThrough articulating these standards we outline a position that encourages responses, and through those responses we will be able to identify points of agreement and contestation that will drive the conversation forward. In that vein, we would encourage researchers, funders and journals to engage with what we have proposed, and respond to us, so that our community of practice of empirical bioethics research can develop and evolve further.

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