Informed consent guidelines for ionising radiation examinations: A Delphi study.

INTRODUCTION: Informed consent for ionising radiation medical imaging examinations is currently undertaken inconsistently in Australian radiographic practice. There is no uniform informed consent process, and opinions vary about how it should be undertaken, and by whom, if indeed it needs to be undertaken at all. To ensure that patients' rights are maintained, the informed consent process must be consistent, proactive in the provision of information, and must empower the patient to formulate and ask questions about their care, and to make voluntary decisions. METHODS: The Delphi technique utilises a group of experts whose individual responses are used to create a collective consensus on a process. This ten-expert (five radiographer, five radiologist) Delphi study examined a basic modelling of the process of informed consent for ionising radiation medical imaging examinations and made recommendations for an ideal process. RESULTS: A series of consensus statements were developed, seeking to rectify areas of the process that were inconsistent, unclear, or ethically unsound. These statements were then considered alongside current codes of professional practice, and Australian law on the duty of disclosure. A model of the ideal process was then developed using these consensus statements and adhering to codes of practice. CONCLUSION: The final process model has a continuity of care and a continuity of information provision. The model eliminates the radiographer as a delegatee, and emphasises physician involvement. The referrer and the radiologist have a shared responsibility of providing risk disclosure information. IMPLICATIONS FOR PRACTICE: For a non-pregnant adult, the ionising radiation dose from conventional radiography is considered insignificant, and does not require risk disclosure, ameliorating the time commitment needed for the process.

Barriers and pathways to informed consent for ionising radiation imaging examinations: A qualitative study.

INTRODUCTION: Informed consent for ionising radiation medical imaging examinations represents a recent change to medical imaging practice. This practice has not had a definitive and authoritative integration into clinical practice, and lack of direction has caused many health care professionals to be unsure of an appropriate consent methodology. Consent practices have been undertaken inconsistently and sometimes poorly. This research sought to investigate what barriers exist to meaningful informed consent, and what pathways are suggested to overcome these barriers. These views are then discussed in the context of practical health care consent practices. METHODS: A semi-structured interview explored the views of radiographers and radiologists on the practice of disclosing the ionising radiation risk of a clinical medical imaging examination. Qualitative data was analysed using a nominal method of quantitative transformation. Responses were reviewed, and a set of definitive themes constructed. Participants considered the influences, logistics and barriers to the informed consent process. Participants were then asked what pathways might be developed that would improve the process. RESULTS: Twenty-one (21) radiographer participants and nine (9) radiologists were interviewed. The barriers to consent identified issues of time constraints, lack of a unified message, and patient presentations. Pathways suggested included limiting the scope of the consent practice, sharing the consent responsibility, and formulation of definitive consent guidelines. CONCLUSION: A unified, definitive series of guidelines for informed consent for ionising radiation examinations would alleviate many of the identified barriers. Having the consent process consistently begin with the referring doctor would facilitate more meaningful consent.

Describing ionising radiation risk in the clinical setting: A systematic review.

INTRODUCTION: Meaningfully explaining the risk of an ionising radiation examination is a challenging undertaking. Patients must contextualise the risk against the expected benefit of the imaging examination, often in a situation of heightened emotion. This systematic review seeks to explore the literature to identify what techniques are advocated for disclosing the risk to patients of ionising radiation from clinical medical imaging examinations. METHODS: A systematic review of peer-reviewed literature was undertaken. Electronic databases were searched to identify peer-reviewed, full-text articles published in English from 1990. Original articles discussing techniques for disclosing ionising radiation risks in the clinical setting were included. The reference lists of the included articles were searched for unpublished articles and reports of use. RESULTS: Sixteen papers out of 5959 unique titles met the inclusion criteria. The data was extracted independently by two researchers and assessed for quality using the Joanna Briggs Institute critical appraisal tools. CONCLUSION: The two most commonly cited techniques for disclosing ionising radiation risk is to compare risk to the risk of common life events, and to describe risk as an additive risk to the baseline risk of cancer. The most commonly cited communication strategy was a graphical representation of the data, but simple language is also advocated. The use of a pictograph represents a technique which satisfied the advocated techniques of most articles.

Medical imaging and informed consent - Can radiographers and patients agree upon a realistic best practice?

INTRODUCTION: For radiographers, gaining informed consent with our patients represents a challenging undertaking. Reconciling the need to gain meaningful consent with time pressures represents one challenge, as does differing expectations of how risk communication should be undertaken. Different methods and thresholds of risk disclosure are considered, with the aim of finding a realistic best practice. METHODS: A cross-sectional study of radiographers and members of the public was undertaken. Participants were asked their preferences for how they would like to receive ionising radiation risk information. This included the health care professional(s) most suited to provide the information, the media through which the information was delivered, and the technique for delivering the information. In addition, participants were asked to consider hypothetical scenarios in which they were a patient receiving an ionising radiation examination, and to give the threshold of ionising radiation cancer risk which they would consider material. These scenarios considered variations in the cancer-onset time, and the accuracy of the test. RESULTS: One hundred and twenty-one (121) radiographer participants and one hundred and seventy two (172) members of the public met the inclusion criteria and completed the survey. There was strong agreement in the most appropriate media, and person, to disclose risk, as well as what represents a significant risk. There was considerable agreement in risk delivery technique. However, some of the agreed-upon strategies may be challenging to achieve in clinical practice. CONCLUSION: Radiographers and patients fundamentally agree upon risk communication strategies, but implementing some strategies may prove clinically challenging.

Ionising radiation risk disclosure: When should radiographers assume a duty to inform?

INTRODUCTION: Autonomy is a fundamental patient right for ethical practice, and informed consent is the mechanism by which health care professionals ensure this right has been respected. The ethical notion of informed consent has evolved alongside legal developments. Under Australian law, a provider who fails to disclose risk may be found to be in breach of a duty of disclosure, potentially facing legal consequences if the patient experiences harm that is attributable to an undisclosed risk. These consequences may include the common law tort of negligence. Ionising radiation, in the form of a medical imaging examination, has the potential to cause harm. However, stochastic effects cannot be attributable to a specific ionising radiation event. What then is the role of the Australian medical imaging service provider in disclosing ionising radiation risk? METHODS: The ethical and legal principles of informed consent, and the duty of information provision to the patient are investigated. These general principles are then applied to the specific and unusual case of ionising radiation, and what responsibilities apply to the medical imaging provider. Finally, the legal, professional and ethical duties of the radiographer to disclose information to their patients are investigated. RESULTS: Australian law is unclear as to whether a radiographer has a common law responsibility to disclose radiation risk. There is ambiguity as to whether stochastic ionising radiation risk could be considered a legal disclosure responsibility. CONCLUSION: While it is unlikely that not disclosing risk will have medicolegal consequences, doing so represents sound ethical practice.