- Title
- Informed consent for clinical examinations involving ionising radiation
- Creator
- Younger, Cameron
- Relation
- University of Newcastle Research Higher Degree Thesis
- Resource Type
- thesis
- Date
- 2020
- Description
- Research Doctorate - Doctor of Philosophy (PhD)
- Description
- Background: Ionising radiation can cause biological effects, including the induction of a cancer. In Australia, the legal standard is that a patient, prior to a medical procedure, should be warned of the ‘significant’ or ‘material’ risks of that procedure. However, the threshold at which a risk of ionising radiation should be considered ‘significant’ is unexplored. In addition, there are currently no defined processes to undertake this process. Aim: The aim of this research was to investigate the question of how and when stochastic radiation risk is communicated to patients, and whether this meets the expectations of all the stakeholders (patients, referrers, radiologists and radiographers) from a legal and ethical perspective. In seeking opinions from the stakeholders a proposed process of informed consent for clinical medical imaging examinations that use ionising radiation was developed. The focus in this research is the disclosure of risk. Key research questions written to focus the research aim included: What is a significant risk? Is there a threshold of when ionising radiation risk should be disclosed? What are the ethical influences for risk disclosure? What are the legal requirements for risk disclosure? What ionising radiation risk disclosure techniques are advocated? Who should be disclosing risk? What is the best risk disclosure method? What barriers exist to ideal risk disclosure practice? What pathways are available for improving the risk disclosure practice? What is the ideal risk disclosure process? Method: A sequential explanatory mixed method, multiphase study was chosen to address the research questions and included four phases: Phase One involved a comprehensive examination of the legal and ethical influences of the informed consent process, and the guidelines of the professional groups of stakeholders. A systematic review was then undertaken which investigated the advocated risk disclosure methodology. A total of seventeen journal articles were assessed, and the findings synthesised into an advocated methodology. Phase Two utilised a cross-sectional questionnaire survey to assess the preferences of hypothetical patients for receiving risk disclosure information. The participants included radiographers (n=121), and members of the public (n=172), in the hypothetical role of a patient. Respondents were asked to identify the most appropriate method and medium to receive ionising radiation risk information, and whom they felt were appropriate professionals to undertake this role. The respondents were also asked to identify the threshold at which an ionising radiation risk became significant. Phase Three involved a series of semi-structured interviews with professional stakeholders, including radiographers (n=21) and radiologists (n=9), to investigate barriers to the risk disclosure process, and pathways to improve the process. Participants were asked questions about the practice of disclosing ionising radiation risk in the clinical environment. The resultant data was reviewed, and using a nominal method of quantitative transformation, and a set of themes constructed. Phase Four focussed on process development. A group of expert participants, including radiographers (n=5) and radiologists (n=5), took part in an e-Delphi study to define an ideal risk disclosure process. This three-round, online investigation started with thirty-one statements, which were accepted if an 80% consensus was reached. Future rounds utilised questions that were redeveloped from those that did not reach consensus, or generated from feedback from earlier responses. After three rounds, a series of statements reached consensus or were considered irreconcilable. The resultant consensus statements were synthesised into a process for disclosing ionising radiation risk in clinical examinations. The resultant theoretical process was then considered against a legal, ethical, practical and professional framework. Results: The results from each of these studies were reported in five publications. In line with a mixed methods design, a meta-synthesis was undertaken to integrate the key results. The research uncovered a number of noteworthy conclusions. Phase One of the research identified that the Australian legal framework requires disclosure of a significant risk, but there are no guidelines of what constitutes a significant ionising radiation risk. Risk disclosure is currently undertaken infrequently, poorly, and without process. There is very little research into this area, and even less documented examples of clinically-integrated practices. In the Australian legal context, it has been advised that the duty to inform to only be legislated for medical practitioners. This phase also found that when the most-advocated techniques of risk disclosure are synthesised, the result is a pictographic representation of risk. Phase Two of the research found that there is considerable agreement between radiographers and members of the public on many aspects of risk disclosure. Both groups agreed that human interaction was the preferred communication pathway (but that information in the form of pamphlets was useful). Both groups agreed that risk should be expressed as odds, preferably in a visual format (such as a pictogram). Both groups identified that radiologists and radiographers were trusted sources to discuss ionising radiation risk, but that members of the public also had trust in the referring physician. Respondents felt that the threshold of what constitutes a significant risk was very low. Phase Three identified that professional stakeholders supported the notion that the process of risk disclosure was done poorly. Respondents indicated that the process was poorly defined, and that a low threshold was prohibitively impractical, in contrast to the members of the public. A threshold of dose equating to fluoroscopic examinations, and CT examinations, was advocated; with plain radiographic examinations not requiring risk disclosure for non-radiosensitive patients. Phase Four resulted in a proposed risk disclosure process of informed consent that must begin with the referring physician, and conclude (where necessary) with the radiologist, with the radiographer supporting the process. The resultant process (potentially including the pictographic method) was found to meet all legal and professional guidelines. Conclusion: The resultant risk disclosure process represents a legal, professionally supported framework. The process meets risk thresholds advocated in previous research, but does not meet the impractical standards of members of the public, as this would be extremely prohibitive for clinical application. The described process could, after clinical testing and assessment, form the basis of a clinical practice guideline. This would, in turn, ensure that Australian patients exposed to significant ionising radiation risk would have the risks disclosed meaningfully and ethically.
- Subject
- medical imaging; ethics; ionising radiation; thesis by publication
- Identifier
- http://hdl.handle.net/1959.13/1428884
- Identifier
- uon:38665
- Rights
- Copyright 2020 Cameron Younger
- Language
- eng
- Full Text
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| View Details Download | ATTACHMENT01 | Thesis | 10 MB | Adobe Acrobat PDF | View Details Download | ||
| View Details Download | ATTACHMENT02 | Abstract | 581 KB | Adobe Acrobat PDF | View Details Download |