| 1. |
- Beard, David J., et al.
(författare)
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Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)
- 2020
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Ingår i: The Lancet. - 0140-6736. ; 395:10226, s. 828-838
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Forskningsöversikt (refereegranskat)abstract
- Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.
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| 2. |
- Beard, David J., et al.
(författare)
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Placebo comparator group selection and use in surgical trials : The aspire project including expert workshop
- 2021
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Ingår i: Health Technology Assessment. - 1366-5278. ; 25:53
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Tidskriftsartikel (refereegranskat)abstract
- Background: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. Conclusions: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space.
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| 3. |
- Bernstein, Michael H, et al.
(författare)
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How do US orthopaedic surgeons view placebo-controlled surgical trials? : A pilot online survey study
- 2022
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Ingår i: Journal of Medical Ethics. - : BMJ Publishing Group Ltd. - 0306-6800 .- 1473-4257.
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Tidskriftsartikel (refereegranskat)abstract
- Randomised placebo-controlled trials (RPCTs) are the gold standard for evaluating novel treatments. However, this design is rarely used in the context of orthopaedic interventions where participants are assigned to a real or placebo surgery. The present study examines attitudes towards RPCTs for orthopaedic surgery among 687 orthopaedic surgeons across the USA. When presented with a vignette describing an RPCT for orthopaedic surgery, 52.3% of participants viewed it as 'completely' or 'mostly' unethical. Participants were also asked to rank-order the value of five different types of evidence supporting the efficacy of a surgery, ranging from RPCT to an anecdotal report. Responses regarding RPCTs were polarised with 26.4% viewing it as the least valuable (even less valuable than an anecdote) and 35.7 .% viewing it as the most valuable. Where equipoise exists, if we want to subject orthopaedic surgeries to the highest standard of evidence (RPCTs) before they are implemented in clinical practice, it will be necessary to educate physicians on the value and ethics of placebo surgery control conditions. Otherwise, invasive procedures may be performed without any benefits beyond possible placebo effects.
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| 4. |
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| 5. |
- Persson, Ingmar, 1951, et al.
(författare)
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Actualizable Potential, Reproduction, and Embryo Research: Bringing Embryos into Existence for Different Purposes or Not at All
- 2010
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Ingår i: CAMBRIDGE QUARTERLY OF HEALTHCARE ETHICS. - 0963-1801. ; 19:1, s. 51-60
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Tidskriftsartikel (refereegranskat)abstract
- It is morally permissible to engage in reproduction, whether natural or artificial, despite knowledge that a large number of embryos will fail to implant and quickly die, thenii) it is morally permissible to produce embryos for other purposes that involve killing them, for instance, to harvest stem cells that may be used to save lives.
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| 6. |
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| 7. |
- Persson, Ingmar, 1951, et al.
(författare)
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Autonomy and the Ethics of Biological Behaviour
- 2014
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Ingår i: The future of Bioethics : international dialogues / edited by Akira Akabayashi. - Oxford : Oxford University Press. - 9780199682676 ; , s. 91-112
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Bokkapitel (refereegranskat)
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| 8. |
- Persson, Ingmar, 1951, et al.
(författare)
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Getting moral enhancement right: the desirability of moral bioenhancement
- 2013
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Ingår i: Bioethics. - : Wiley. - 0269-9702 .- 1467-8519. ; 27:3, s. 124-31
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Tidskriftsartikel (refereegranskat)abstract
- We respond to a number of objections raised by John Harris in this journal to our argument that we should pursue genetic and other biological means of morally enhancing human beings (moral bioenhancement). We claim that human beings now have at their disposal means of wiping out life on Earth and that traditional methods of moral education are probably insufficient to achieve the moral enhancement required to ensure that this will not happen. Hence, we argue, moral bioenhancement should be sought and applied. We argue that cognitive enhancement and technological progress raise acute problems because it is easier to harm than to benefit. We address objections to this argument. We also respond to objections that moral bioenhancement: (1) interferes with freedom; (2) cannot be made to target immoral dispositions precisely; (3) is redundant, since cognitive enhancement by itself suffices.
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| 9. |
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| 10. |
- Persson, Ingmar, 1951, et al.
(författare)
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'Moral Transhumanism'
- 2010
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Ingår i: Journal of Medicine and Philosophy. ; 35, s. 656-669
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Tidskriftsartikel (refereegranskat)
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