Ethical challenges of innovative surgery: a response to the IDEAL recommendations

Johnson, Jane; Rogers, Wendy; Lotz, Mianna; Townley, Cynthia; Meyerson, Denise; Tomossy, George F.

doi:10.1016/s0140-6736(10)61116-6

Cited by 21 publications

(23 citation statements)

References 6 publications

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“…Therefore, it is important to encourage surgical innovation and to disseminate its results so that the maximum number of patients can reap its benefits. However, along with these potential benefits, surgical innovation brings with it many risks of harm 1. These risks arise partly because much innovation occurs without the kind of oversight that applies to research 4.…”

Section: Introductionmentioning

confidence: 99%

“…Progress in the field of surgery, in fact, relies on innovations ranging from continuous incremental improvement to revolutionary techniques or technologies. [1][2][3] Therefore, it is important to encourage surgical innovation and to disseminate its results so that the maximum number of patients can reap its benefits. However, along with these potential benefits, surgical innovation brings with it many risks of harm.…”

Section: Introductionmentioning

confidence: 99%

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Macquarie Surgical Innovation Identification Tool (MSIIT): a study protocol for a usability and pilot test

et al. 2016

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IntroductionMedicine relies on innovation to continually improve. However, innovation is potentially risky, and not all innovations are successful. Therefore, it is important to identify innovations prospectively and provide support, to make innovation as safe and effective as possible. The Macquarie Surgical Innovation Identification Tool (MSIIT) is a simple checklist designed as a practical tool for hospitals to identify planned surgical innovations. This project aims to test the usability and pilot the use of the MSIIT in a surgical setting.Methods and analysisThe project will run in two phases at two Australian hospitals, one public and one private. Phase I will involve interviews, focus groups and a survey of hospital administrators and surgical teams to assess the usability and system requirements for the use of the MSIIT. Current practice regarding surgical innovation within participating hospitals will be mapped, and the best implementation strategy for MSIIT completion will be established. Phase II will involve trialling the MSIIT for each surgery within the trial period by various surgical personnel. Follow-up interviews, focus groups and a survey will be conducted with trial participants to collect feedback on their experience of using the MSIIT during the trial period. Comparative data on rates of surgical innovation during the trial period will also be gathered from existing hospital systems and compared to the rates identified by the MSIIT.Ethics and disseminationEthical approval has been obtained. The results of this study will be presented to interested health services and other stakeholders, presented at conferences and published in a peer-reviewed MEDLINE-indexed journal.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Macquarie Surgical Innovation Identification Tool (MSIIT): a study protocol for a usability and pilot test

et al. 2016

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“…Support for this capability is particularly important for continually evolving trans-institutional care processes that involve more than one treatment alternative. Such support could alleviate the challenge of individual development of new surgical skills while also maintaining existing skills in standard treatment, provide effective dissemination of data to substantiate the new procedure's effectiveness and reduce competency-related risks for patients 25 26. In order to support the generation and dissemination of knowledge, the system should provide the following:

Feedback on process and outcome parameters for the patient group to all clinicians involved.

…”

Section: Discussionmentioning

confidence: 99%

Process support for risk mitigation: a case study of variability and resilience in vascular surgery

Brattheim¹,

Faxvaag

Seim

2011

BMJ Quality & Safety

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ObjectiveTo inform the design of IT support, the authors explored the characteristics and sources of process variability in a surgical care process that transcends multiple institutions and professional boundaries.SettingA case study of the care process in the Abdominal Aortic Aneurysm surveillance programme of three hospitals in Norway.DesignObservational study of encounters between patients and surgeons accompanied by semistructured interviews of patients and key health personnel.ResultsFour process variety dimensions were identified. The captured process variations were further classified into intended and unintended variations according to the cause of the variations. Our main findings, however, suggest that the care process is best understood as systematised analysis and mitigation of risk. Even if major variations accommodated for the flexibility needed to achieve particular clinical aims and/or to satisfy patient preferences, other variations reflected healthcare actors' responses to risks arising from a lack of resilience in the existing system. On this basis, the authors outlined suggestions for a resilience-based approach by including awareness in workflow as well as feedback loops for adaptive learning. The authors suggest that IT process support should be designed to prevent process breakdowns with patient dropouts as well as to sustain risk-mitigating performance.ConclusionProcess variation was in part induced by systemised risk mitigation. IT-based process support for monitoring processes such as that studied here should aim to ensure resilience and further mitigate risk to enhance patient safety.

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“…There will always be a first in human, and always first in human with what turns out to be problematic feature x . Recently, models have been proposed for addressing the evidence gap,7–9 but as has been argued, these models do not deal with all of the ethical challenges 10…”

Section: Addressing the Ethical Issuesmentioning

confidence: 99%

Innovative surgery: the ethical challenges

Johnson

Rogers

2011

J Med Ethics

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Innovative surgery raises four kinds of ethical challenges: potential harms to patients; compromised informed consent; unfair allocation of healthcare resources; and conflicts of interest. Lack of adequate data on innovations and lack of regulatory oversight contribute to these ethical challenges. In this paper these issues and the extent to which problems may be resolved by better evidence-gathering and more comprehensive regulation are explored. It is suggested that some ethical issues will be more resistant to resolution than others, owing to special features of both surgery and innovation.

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Ethical challenges of innovative surgery: a response to the IDEAL recommendations

Cited by 21 publications

References 6 publications

Macquarie Surgical Innovation Identification Tool (MSIIT): a study protocol for a usability and pilot test

Macquarie Surgical Innovation Identification Tool (MSIIT): a study protocol for a usability and pilot test

Process support for risk mitigation: a case study of variability and resilience in vascular surgery

Innovative surgery: the ethical challenges

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