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8. Further considerations for placebo controls in surgical trials.

Author

Campbell, Marion K., Beard, David J., Blazeby, Jane M., Cousins, Sian, Ahmed, Ahmed, Al-Lamee, Rasha, Anderson, David B., Blencowe, Natalie, Cook, Jonathan, Cuthbertson, Brian H., Ferreira, Manuela, Gardiner, Matt, Gillies, Katie, Miola, José, Norrie, John, Pinkney, Tom, Pugh, Jonathan, Rovers, Maroeska, Stocken, Deborah, and Westmore, Matt

Subjects
PLACEBOS, DECISION making, ADVICE
Abstract

The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making. [ABSTRACT FROM AUTHOR]

Published
2023
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15. Editorial

Author

Fovargue, Sara, primary, Miola, José, additional, Clough, Beverley, additional, and Heywood, Rob, additional

Published
2021
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21. The far-reaching implications of Montgomery for risk disclosure in practice

Author

Devaney, Sarah, Purshouse, Craig, Cave, Emma, Heywood, Rob, Miola, José, and Reinach, Nina

Subjects
professional guidance, Negligence, Montgomery, ComputingMilieux_COMPUTERSANDSOCIETY, ComputingMilieux_LEGALASPECTSOFCOMPUTING, risk disclosure, Informed consent, humanities
Abstract

The UK Supreme Court held in Montgomery v Lanarkshire HB (2015) that practitioners must take reasonable care to ensure patients are aware of any material risks involved in treatment. We reviewed all court decisions since Montgomery which deal with the case, to establish how this judgment is being interpreted by the courts and the implications of this for risk disclosure in practice. We found that Montgomery’s application has been expanded in a number of ways: information about reasonable alternatives includes the provision of information about their risks and benefits; Montgomery applies to post- as well as pre-operative disclosure; and the timing of discussion with patients about risks is important. Conversely, there is evidence that the parameters of Montgomery are being curtailed, giving rise to questions about judicial commitment to patient autonomy. In some cases there is focus on the objective risks of procedures as opposed to patients’ subjective concerns; in others, causation of injury is sometimes a factor that will defeat claims. There are also further questions about whether patients now should accept more responsibility for the outcome of decisions they make. We conclude that practitioners engaged in discussions about the risks of proposed treatments and their alternatives have been left in a position of uncertainty by the courts in relation to the obtaining of informed consent in practice. It is now critical that updated guidance is provided by the UK General Medical Council to give practitioners and service providers confidence that they are adhering to the law.

Published
2019

23. Putting the Morals Back into Medicine - Emphasizing the 'We' over the 'Me'.

Author

MIOLA, JOSÉ

Subjects
CORONAVIRUS diseases, HEALTH care industry, SOLIDARITY
Abstract

The author comments on an article on macromedical regulation in the U.S. by professors Barak D. Richman and Steven L. Schwarcz. Topics include the author's view about the importance of macromedical regulation in the wake of a public health emergency such as the COVID-19 pandemic, his arguments on the use of the concept of solidarity and the key role of reciprocity, a principle proposed to support the notion of macromedical regulation, and the problem with autonomy.

Published
2021

24. Corrigendum to: Cohort profile: Extended Cohort for E-health, Environment and DNA (EXCEED)

Author

John, Catherine, primary, Reeve, Nicola F, additional, Free, Robert C, additional, Williams, Alexander T, additional, Ntalla, Ioanna, additional, Farmaki, Aliki-Eleni, additional, Bethea, Jane, additional, Barton, Linda M, additional, Shrine, Nick, additional, Batini, Chiara, additional, Packer, Richard, additional, Terry, Sarah, additional, Hargadon, Beverley, additional, Wang, Qingning, additional, Melbourne, Carl A, additional, Adams, Emma L, additional, Bee, Catherine E, additional, Harrington, Kyla, additional, Miola, José, additional, Brunskill, Nigel J, additional, Brightling, Christopher E, additional, Barwell, Julian, additional, Wallace, Susan E, additional, Hsu, Ron, additional, Shepherd, David J, additional, Hollox, Edward J, additional, Wain, Louise V, additional, and Tobin, Martin D, additional

Published
2019
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25. Cohort Profile: Extended Cohort for E-health, Environment and DNA (EXCEED)

Author

John, Catherine, primary, Reeve, Nicola F, additional, Free, Robert C, additional, Williams, Alexander T, additional, Ntalla, Ioanna, additional, Farmaki, Aliki-Eleni, additional, Bethea, Jane, additional, Barton, Linda M, additional, Shrine, Nick, additional, Batini, Chiara, additional, Packer, Richard, additional, Terry, Sarah, additional, Hargadon, Beverley, additional, Wang, Qingning, additional, Melbourne, Carl A, additional, Adams, Emma L, additional, Bee, Catherine E, additional, Harrington, Kyla, additional, Miola, José, additional, Brunskill, Nigel J, additional, Brightling, Christopher E, additional, Barwell, Julian, additional, Wallace, Susan E, additional, Hsu, Ron, additional, Shepherd, David J, additional, Hollox, Edward J, additional, Wain, Louise V, additional, and Tobin, Martin D, additional

Published
2019
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28. WOULD WE BE RIGHT TO TRY "RIGHT TO TRY"?

Author

Miola, José and Richards, Bernadette J.

Subjects
*EXPERIMENTAL medicine laws, *RIGHT to health, *DRUG accessibility, *MEDICAL laws, *DRUG laws
Abstract

In both the United Kingdom and United States of America legislation has been proposed or enacted which claims to provide patients with a 'right' of access to experimental drugs and treatments where there is no other hope. In this paper we will explore this narrative and consider the steps taken in the United States to shift to a more rights driven legal framework. The paper will critically assess the United States model and the similarly framed 'Saatchi' model in the United Kingdom; demonstrating that, despite the rights-based narrative, these laws do not represent a significant change in access to treatment for patients. Rather, the reality is that this 'right to try' paradigm represents a patient advocate narrative that is deeply flawed. It fails to implement any meaningful change, exposes vulnerable patients to risk of harm and, potentially, delays safe development of potentially life-saving treatment regimes. [ABSTRACT FROM AUTHOR]

Published
2021

29. Cohort Profile: Extended Cohort for E-health, Environment and DNA (EXCEED)

Author

John, Catherine, primary, Reeve, Nicola F, additional, Free, Robert C, additional, Williams, Alexander T, additional, Farmaki, Aliki-Eleni, additional, Bethea, Jane, additional, Barton, Linda M, additional, Shrine, Nick, additional, Batini, Chiara, additional, Packer, Richard, additional, Terry, Sarah, additional, Hargadon, Beverley, additional, Wang, Qingning, additional, Melbourne, Carl A, additional, Adams, Emma L, additional, Bee, Catherine E, additional, Harrington, Kyla, additional, Miola, José, additional, Brunskill, Nigel J, additional, Brightling, Christopher E, additional, Barwell, Julian, additional, Wallace, Susan E, additional, Hsu, Ron, additional, Shepherd, David J, additional, Hollox, Edward J, additional, Wain, Louise V, additional, and Tobin, Martin D, additional

Published
2018
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33. Leaf area and intermittent misting on hop plants propagation by stem cuttings.

Author

NUNES GOMES, ERIK, PEREIRA MACHADO, MARÍLIA, MIOLA, JOSÉ, and DESCHAMPS, CÍCERO

Subjects
HOPS, BREWING, LEAF area, ROOTING of plant cuttings, GREENHOUSE gardening
Abstract

Copyright of Revista Colombiana de Ciencias Hortícolas is the property of Revista Colombiana de Ciencias Horticolas and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2018
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36. Innovation in medicine through degeneration in law? A critical perspective on the Medical Innovation Bill

Author

Hoppe, Nils, Miola, José, Hoppe, Nils, and Miola, José

Abstract

The current debate surrounding the Medical Innovation Bill purports to be aimed at improving the normative framework to the extent that innovation is more likely. A closer look at the mechanisms of the proposed legislation and a more detailed assessment of the reasons given for initiating the legislative process in this instance reveal that the Bill seem to rest on a significant misunderstanding of the current law of medical negligence. This article analyses the provisions of the Bill, puts them into the wider context of medical negligence and critically reviews the utility of the proposed legislation. © The Author(s) 2014.

Published
2014

41. Shifting the focus

Author

Fovargue, Sara, Miola, José, Fovargue, Sara, and Miola, José

Published
2010

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