Guidelines for Informed Consent - RANZCR

Guidelines for Informed Consent

FACULTY OF RADIATION ONCOLOGY

THE ROYAL AUSTRALIAN AND NEW ZEALAND COLLEGE OF RADIOLOGISTS®

Faculty of Radiation Oncology Guidelines for Informed Consent

Radiation Oncology

Guideline

Name of document and version: Faculty of Radiation Oncology Guidelines for Informed Consent, Version 3.0

Approved by: Faculty of Radiation Oncology

Date of approval: March 2021

ABN 37 000 029 863 Copyright for this publication rests with The Royal Australian and New Zealand College of Radiologists®

The Royal Australian and New Zealand College of Radiologists Level 9, 51 Druitt Street Sydney NSW 2000 Australia

New Zealand Office: Floor 6, 142 Lambton Quay, Wellington 6011, New Zealand

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Email: [email protected] Website: www.ranzcr.edu.au Telephone: +61 2 9268 9777 Facsimile: +61 2 9268 9799

Disclaimer: The information provided in this document is of a general nature only and is not intended as a substitute for medical or legal advice. It is designed to support, not replace, the relationship that exists between a patient and his/her doctor.

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TABLE OF CONTENTS

1. Introduction 5 2. Principles and Elements of consent and Informed Consent 5 3. Communication and Consent 6 4. Reviewing Consent 9 5. Consent to Research 9 6. Special considerations 9 7. Faculty of Radiation Oncology Recommendations 10 8. Informed Financial Consent 11 9. Summary 11 Comments and Review 11 Appendix A – Discussion Briefs 12 Appendix B – Literature Review of Communication Strategies 15 References 17

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About the College

The Royal Australian and New Zealand College of Radiologists (RANZCR) is a not-for-profit association of members who deliver skills, knowledge, insight, time and commitments to promote the science and practice of the medical specialties of clinical radiology (diagnostic and interventional) and radiation oncology in Australia and New Zealand.

The Faculty of Radiation Oncology, RANZCR, is the peak bi-national body advancing patient care and the specialty of radiation oncology through setting of quality standards, producing excellent radiation oncology specialists, and driving research, innovation and collaboration in the treatment of cancer.

Our Vision

RANZCR as the peak group driving best practice in clinical radiology and radiation oncology for the benefit of our patients.

Our Mission

To drive the appropriate, proper and safe use of radiological and radiation oncological medical services for optimum health outcomes by leading, training and sustaining our professionals.

Our Values

Commitment to Best Practice

Exemplified through an evidence-based culture, a focus on patient outcomes and equity of access to high quality care; an attitude of compassion and empathy.

Acting with Integrity

Exemplified through an ethical approach: doing what is right, not what is expedient; a forward thinking and collaborative attitude and patient-centric focus.

Accountability

Exemplified through strong leadership that is accountable to members; patient engagement at professional and organisational levels.

Code of Ethics

The Code defines the values and principles that underpin the best practice of clinical radiology and radiation oncology and makes explicit the standards of ethical conduct the College expects of its members.

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1. INTRODUCTIONThis document is designed to provide guidance to be followed when seeking patients’ consent to receive radiation therapy. It highlights the principles underlying informed and valid consent, and the importance of clear communication between doctors and patients. Further general reference can be made to the NHMRC General guidelines for Medical Practitioners on providing information for patients,(1) the General Medical Council (UK) document on Seeking Patient’s Consent(2) and the Medical Board of Australia’s Good Medical Practice: A Code of Conduct for Doctors in Australia(3)

2. PRINCIPLES AND ELEMENTS OF CONSENT AND INFORMED CONSENTCurrent biomedical ethics rest on the principles of “beneficence, non-maleficence” (“do no harm”) and respect for patient autonomy and self-determination.(4) Successful relationships between doctors and patients depend on communication and trust. A key component is the professional’s respect for patients’ autonomy—their right to decide whether or not to undergo any medical intervention even where a refusal may result in harm to themselves or in their own death.

Informed consent is a person’s voluntary decision about medical care that is made with knowledge and understanding of the benefits and risks involved.(3)

Valid consent implies that the patient has given consent in accordance with legal requirements, resulting in genuine consent being given.

The basic elements of obtaining valid consent for any medical intervention are: 1. It must be voluntary; given without coercion, duress, misrepresentation, manipulation or fraud.2. It must be specific and cover the procedure or treatment performed3. The patient must have the capacity to consent, that is, to be competent and autonomous and to

be able to understand the implications of having treatment.

The guidelines are based on the general principle that patients are entitled to make their own decisions about medical treatments or procedures and should be given adequate information on which to base those decisions. Information should be provided in a form and manner that helps patients to understand the problem and treatment options available, and are appropriate to the patient’s circumstances, personality, expectations, fears, beliefs, values, and cultural background. Doctors should give advice and answer questions openly. The patient is free to accept or reject the advice and should be encouraged to make his or her own decision. In return, patients should be frank and honest in giving information about their health to assist the doctor in offering the correct advice.

Informed consent is about ensuring a patient has all necessary information to make a properly informed decision about their health care. It involves disclosing ‘material risks’ to a patient, which are those that—in the circumstances of the particular case—are either such that: 1. a reasonable person in the patient's position, if warned of the risk, would be likely to attach

significance to it; orfor that the particular patient, if the doctor is, or should reasonably be, aware that if that patient was warned of the risk, they would be likely to attach significance to it.

The ‘reasonable person’ standard identifies a level of information that would enable the hypothetical reasonable person to reach a decision. While aimed at accommodating the patient’s requirements rather than the professions’, it is difficult to generalise to all, or to individualise to a particular patient’s needs. The ‘subjective’ standard (i.e. the particular patient) is one that recognises the individual’s requirements, although it may be difficult for a professional to assess those needs.

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3. COMMUNICATION AND CONSENT

THE NEED FOR EFFECTIVE COMMUNICATION

Higher levels of patient satisfaction, compliance, and psychological adjustment in response to the threat of a cancer diagnosis is associated with greater acquisition of information by patients.(5, 6) Lack of information can lead to an exacerbation of fear, diminishing the patient’s belief in the benefits of such treatment, and to misinterpretation of the symptoms and side effects the patient may experience.(7) Patients undergoing radiation therapy have multiple fears, anxieties, stress, and expectations.(8, 9)

Individual patients’ needs during the ‘informing’ process for are highly variable. There is increasing evidence in the literature that providing patients with more individualised information can reduce anxiety and improve satisfaction.(10, 11) Tailoring information to patients’ needs is still a difficult process because patients react differently with regard to anxiety, depression and satisfaction depending on their information needs and personality type. Thomas et al(12) found, perhaps paradoxically, that patients who wanted all available information had significantly higher levels of anxiety than those who preferred to let the doctor decide. In the Swedish study,(10) avoidance was negatively correlated with information satisfaction suggesting that these patients would prefer less information.

Incorporating this increasing body of evidence about a patient’s personality type, their information needs, and their anxiety / satisfaction levels into optimal communication with the patient is complex. The doctor will not necessarily be aware of a patient’s individual information needs at the time at which informed consent is sought. Providing written information about the procedure in clear, plain English (or the patient’s native language) is to be encouraged as a means of reinforcing personal communication between the doctor and the patient. It also addresses the issue of poor patient recall,(13) which is a particular problem with increasing age and with the anxiety of a cancer diagnosis.(14, 15)

Reasonable estimates of risks should be provided as part of the informed consent process and where there is uncertainty or lack of knowledge this must be discussed with the patient. There is enormous variability in risk estimates for radiation therapy and this is influenced by the specific disease and the experience of the radiation oncologist.(16) There can also be a degree of uncertainty about the nature and severity of the potential risks and this should be discussed in an open exchange between the patient and the doctor.

One difficulty encountered may be that of accurately describing all side effects of treatment. To overcome this, the patient may be asked directly if there are any particular concerns or side effects that would make them wish to avoid treatment.

Treatment with radiation therapy has particular facets that require consideration (refer to Appendix A). The types of claims made against radiation oncologists are most commonly related to either to failure to warn about the late effects of radiation therapy, or about potential treatment errors. The patient needs to understand that both early and late side effects may occur, and that late effects may develop months or even years after treatment. Some of these late effects can be severe yet still compatible with survival. The radiation oncologist must ensure as far as possible that all care is taken to minimise such risks.

The process of obtaining consent The following sections provide guidance regarding the process of obtaining consent, what may need to be discussed, and other relevant issues. Topics for discussion specific to radiation therapy are detailed in Appendix A.

The radiation oncologist prescribing treatment has the responsibility of discussing it with the patient and obtaining informed consent, based on comprehensive understanding of the treatment, how it is carried out, and the risks attached to it. Where this is not practicable, the tasks may be delegated provided this person:

• is suitably trained and qualified;

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• has sufficient knowledge of the proposed investigation or treatment, and understands the risks involved.

The prescribing radiation oncologist will remain responsible for ensuring that the patient has been given sufficient time and information to make an informed decision, and has given valid consent to the procedure before any treatment starts.

The way the doctor gives information should help the patient understand the illness, its options for management, and the reasons for any intervention. It may sometimes be helpful to convey information in more than one session. The doctor should: 1. communicate information and opinions in a form the patient can understand; 2. encourage the patient to reflect on opinions, ask more questions, consult with family, friends or

advisor, such as their general practitioner; 3. repeat key information to help the patient understand and remember it; 4. give written information or use diagrams, where appropriate; 5. pay careful attention to the patient’s responses to help identify what has or has not been

understood; 6. involve nursing or other members of the health care team in discussions with the patient, where

appropriate. They may have valuable knowledge of the patient’s background or particular concerns which, for example, would help in identifying the risks to be discussed;

7. ensure that, where treatment is not to start until sometime after consent has been obtained, the patient is given a clear route for reviewing their decision with the person providing the treatment;

8. use a professional interpreter when the patient is not fluent in English.

The approach used by the doctor will reflect a combination of all those described above, and the judgment on what risks to include and discuss will be influenced by: 1. the seriousness of the patient’s condition. More information is required the greater the risk of

harm (either from disease or treatment) and the more serious the harm is likely to be; 2. the nature of the intervention; for example, whether it is complex or straightforward, and whether

there is likely to be general public understanding of what it entails; 3. the types of questions asked by the patient. Careful attention to the questions will help define

what is important to the patient; 4. the patient’s temperament, attitude and level of understanding. Every patient is entitled to

information, but these factors may provide guidance as to the form it takes; 5. the patient’s circumstances that might influence their reaction to particular risks; 6. current accepted medical practice.

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Responding to questions from patients about treatment You must respond honestly to any questions the patient raises and, as far as possible, answer as fully as the patient wishes. In some cases, a patient may ask about other treatments that are unproven or ineffective. Some patients may want to know whether any of the risks or benefits of treatment are affected by the choice of institution or doctor providing the care. You must answer such questions as fully, accurately and objectively as possible.

Withholding information Information should be withheld in very limited circumstances only: 1. If the doctor judges on reasonable grounds that the patient’s physical or mental health might be

seriously harmed by the information (these situations are rare); 2. If the patient expressly directs the doctor to make the decisions and indicates that he or she does

not want the offered information. In this situation consider the need for an assessment of the patient’s capacity, and seeking advice from experienced colleagues;

3. In an emergency, when immediate intervention is necessary to preserve life (although this is a very unlikely circumstance in the practice of radiation oncology).

Refusal of treatment The patient has a right to refuse treatment. The practitioner must ensure that the patient understands why the treatment is being offered, what it comprises, and the consequences of refusing to undergo

A framework for discussion

The following are suggested areas to include in the discussion in the process of obtaining valid consent:

Diagnosis 1. the type of cancer diagnosis; 2. what the illness means in terms of its severity and its effects on the body; 3. the proposed approach to investigation; 4. other options for investigation; 5. the degree of uncertainty of the diagnosis (if relevant).

Treatment 1. the proposed approach to treatment; 2. the purpose of the treatment (curative or palliative); 3. the expected benefits of treatment, such as the chance of cure or of reducing the risk of

recurrence; 4. common side effects and material risks of treatment, explaining what they mean for the

patient and their incidence; 5. any significant long term physical, emotional, mental, social, sexual, or other outcome

relevant to the patient’s specific needs; 6. the degree of uncertainty about the therapeutic outcome; 7. the likely consequences of not choosing the proposed treatment, or of not having any

treatment at all; 8. other treatment options; 9. whether the treatment is conventional, emerging/unproven or experimental.

Practical issues 1. who will undertake the intervention; 2. the time involved; 3. the planning and treatment processes; 4. whether qualified doctors in training will be involved, and the extent to which students

may be involved; 5. a reminder that patients can change their minds about a decision at any time; 6. a reminder that patients have a right to seek a second opinion; 7. the costs involved, including out of pocket costs.

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the recommended course of treatment. It is recommended that the patient gives a written acknowledgment of refusal of medical treatment, in which the patient acknowledges the potential risks and implications explained to them, witnessed by the practitioner and another individual.

4. REVIEWING CONSENT

A signed consent form is not sufficient evidence that a patient has given, or still gives, informed consent to the proposed treatment in all its aspects. You, or a member of the team, must review the patient’s decision close to the time of treatment, and especially where:

• significant time has elapsed between obtaining consent and the start of treatment; • there have been material changes in the patient’s condition, or in any aspects of the proposed

treatment plan, which might invalidate the patient’s existing consent; • new, potentially relevant information has become available, for example about the risks of the

treatment, or about other treatment options.

5. CONSENT TO RESEARCH

Patients should be informed that their data will be collected and stored and may be used for quality assurance purposes. This is good practice and helps maintain and improve service delivery standards. The data may also be used for research, but all such research requires the approval of an institutional Human Research Ethics Committee.

Research involving clinical trials of drugs or treatments, and into the causes of, or possible treatment for, a particular condition, is important in improving effective care for present and future patients. The benefits of the research may be uncertain and may not be experienced by the person participating in the research. In addition, the risk involved for research participants may be difficult to identify or to assess in advance. If you undertake or participate in research involving patients or volunteers, it is particularly important that you ensure:

• that the protocol has been approved by a properly constituted Human Research Ethics Committee

• as far as you are able, that the research is not contrary to the individual’s interests; • that the participant understands that it is research and that the results are not predictable.

You should seek further advice where your research will involve adults who are not able to make decisions for themselves, or children.

6. SPECIAL CONSIDERATIONS

1. You must declare any potential conflicts of interest (3, 17), for example where you or your organisation benefit financially from use of a particular drug or treatment, or treatment at a particular institution.

2. When a radiation oncology department has a waiting list, an explanation should be given to the patient as to the likely waiting time, the possible effects (if any) on the outcomes of treatment, what measures can be taken to mitigate the effects; and an explanation of how the department manages its waiting times within the available resources.

3. Pressure may be put on patients by employers, insurance companies or others to undergo particular tests or accept treatment. You should do your best to ensure that patients have considered the options and reached their own decision. You should take appropriate action if you believe patients are being offered inappropriate or unlawful financial or other rewards. You can liaise with appropriate colleagues or seek professional advice in these circumstances before deciding on what, if any, action to take.

4. Patients who are detained by the police or immigration services, or are in prison, and those detained under the provisions of any mental health legislation may be particularly vulnerable. Where such patients have a right to decline treatment you should do your best to ensure that they know this and are able to exercise this right.

5. If you are treating a patient who has lost capacity to consent to or refuse treatment, for example through onset or progression of cognitive dysfunction or other disability, you should try to find out whether the patient has previously indicated preferences in an advance statement (i.e. ‘advance

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care directives’ or similar document). You must respect any refusal of treatment given when the patient was competent, provided the decision in the advance statement is clearly applicable to the present circumstances, and there is no reason to believe that the patient has changed his or her mind. Where an advance statement of this kind is not available, the patient’s known wishes should be taken into account.

7. FACULTY OF RADIATION ONCOLOGY RECOMMENDATIONS

• Consent to radiation treatment should ideally be given in writing by the patient and countersigned by the radiation oncologist or their medical delegate, to record the information provided and the agreement made between the two parties. If written consent is not obtained, the justification for not obtaining it should be clearly documented. The shared information and decision-making model is now a well-recognised as a model for this interaction. The patient’s right to high-quality, appropriate information is reflected in the medico-legal framework and patient rights charters in the Western world. Because the most serious unwanted effects of radiation therapy often occur many years after the delivery of the treatment, it is generally insufficient for the patient and radiation oncologist to rely on the memory of consent obtained verbally.

• Radiation oncologists should document the process of obtaining valid consent, including the rationale for treatment, radiation therapy schedule, acute and late toxicities, if the patient had any specific queries or concerns, and if an interpreter was present. The process of obtaining valid consent is different for each patient and the subtleties cannot be fully captured with a signed consent form. Detailed notes of the information provided to the patient should be made in the medical records, and should be included in a letter back to referring doctor, general practitioner, and other significant care providers.

• The patient should be given as a minimum both verbal and written information in plain language, relevant to their needs. Patients are often asked to make choices between different treatment options, and nearly all wish to be involved in decision-making regarding their care. To assist patients in making decisions that are based upon good medical evidence and advice but are compatible with their own values and personal life issues, radiation oncologists should provide relevant information in an easy-to-understand form. Patients being consented for radiation therapy for a frequently treated cancer, for example, breast, prostate, are entitled to generic written information that includes possible unwanted effects of the radiation therapy, together with any other information that is relevant to them and specific to their circumstances.

In accordance with the judgement in Rogers v Whitaker (1992) 175 CLR 479, any complication that could be perceived as of significance to the patient—no matter how rare—must be discussed and documented. More frequent ones should automatically be listed, together with what they mean for the patient in terms they can understand, and the percentage of cases affected. Thus the level of information given is not dissimilar to that provided on a good clinical trial information sheet.(18) The patient and family should be given adequate time for decision-making and obtaining the opinion of others if required.

There is good evidence to show that patients who are rushed or pressured into treatment decisions are more likely to subsequently express dissatisfaction with their treatment and emotional wellbeing.

• All information sheets on the risks of radiation therapy for specific cancers should contain a section on the generic risks of radiation therapy, in particular the risk of second primary malignancy (SPM), and possible effects on reproductive integrity. These generic risks should be provided on a separate sheet when consenting a person with a rare cancer for which there is no disease-specific information sheet. As cancer survival rates improve around the Western world over the last 30 years the problem of second primary malignancies (SPM) has become a concern. Cancer services and individual Departments should aim to standardise the information delivered to patients referred to their

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radiation service for treatment. Regular up-skilling of clinical staff in effective communication may be necessary to achieve uniformly high standards.

For most patients requiring treatment for cancer, the oncologist is the most important source of information. However, it is not uncommon for patients to feel dissatisfied with the information supplied by the oncologist, and the way it was delivered. Frequently patients comment that they were unable to absorb all that was discussed during a consultation.

• Departments should consider strategies of proven value to improve the patient information process. These include; decision aides, audio taping, digitally encoded files, internet resources, peak-advocacy-body sites and other multi-media techniques.

8. INFORMED FINANCIAL CONSENT The College supports the principle that patients should be asked to provide Informed Financial Consent (IFC) prior to commencing medical treatment for possible incurred fees for treatment.

The patient should be given sufficient, clear information regarding his or her likely fees and the associated rebates so that he or she is able to make an informed financial decision prior to the provision of treatment and, where necessary, any alternative ways to access that treatment. Where out-of-pocket expenses are anticipated, information about fees and charges for proposed services should be provided to patients in writing, and a signed acknowledgement of IFC should be sought from the patient prior to treatment commencing.

The College acknowledges that it is important to advise the patient that the fees and charges discussed are an estimate only and that due to unforeseen circumstances the treatment and costs may need to be varied, and hence the fees may change. The patient should be advised of any change in writing.

The College recommends that, in addition to providing specific information on fees and charges, general information regarding billing policies should be provided to all patients including when payment will be required, any discounts available for early payment (or charges for late payment), acceptable forms of payment; and contacts for discussion of payment issues and problems.

9. SUMMARY

Accurate, comprehensive and understandable information must be given to the patient to obtain consent prior to radiation therapy. Guidelines are provided to facilitate the process of communication. Information on the diagnosis, types of treatment available, the procedures and outcomes must be explained. The details of the information discussed should be clearly documented in the record or on the written consent form.

COMMENTS AND REVIEW The Faculty of Radiation Oncology aims to review professional documents within three years of the date of approval. If you have any comments or feedback to be considered at the next review, please email [email protected]

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APPENDIX A – DISCUSSION BRIEFS 1. Dose response in tumours and normal tissues

The rationale underlying the dose fractionation schedules in radiation therapy may be difficult to understand for the lay person, but it is helpful to explain to the patient why a particular schedule has been prescribed. In curative treatments, there is an obvious trade-off between using a radiation dose that is high enough to eliminate the cancer and trying to avoid any significant dose to normal tissues that would result in side effects. Fractionation is undertaken to protect the normal tissues, allowing recovery between treatments, thus helping to reduce side effects. This allows a higher dose to be given to the tumour, as it does not recover as well as the normal tissues, and increases the chances of cure.

The radiation dose prescribed for a patient having curative treatment is usually based on the tolerance of the normal tissues irradiated. In a group of patients with the same type of cancer, some will require higher doses of radiation therapy to control the cancer than others. In some people this dose would be higher than the normal tissues can cope with, although it is not possible to know this in advance. Therefore, patients are treated with a standard schedule that should not cause significant damage in the majority of patients, but in some people this dose will not be curative. Prescribing higher doses in an attempt to control all the cancers would result in major and unacceptable damage to the normal tissues.

2. Acute and late reactions Side effects from medical treatments are usually closely related in time to the delivery of the treatment. By contrast, radiation therapy produces not only acute or early reactions, but also reactions that may persist for months or years after treatment, or indeed only emerge several years later. The concept of late injury needs clear explanation to the patient.

Acute reactions are generally predictable and depend on dose and dose intensity, the site and volume treated and individual sensitivity. Within these parameters it is usually straight-forward to describe exactly what the patient should expect in term of type of reaction, the time course of appearance and healing, the severity and what can be done to treat the symptoms.

Radiation fractionation schedules are essentially designed to minimise the risk of late morbidity, based on dose limitations that observe the tolerance of the key normal tissues. It should be recognised that these tolerances are applicable to the vast majority of patients, but that a small proportion of patients will suffer significant late effects even when treated within generally tolerated dose limits. Although co-morbidities such as diabetes may be implicated in some cases, it is generally not possible to predict who will fall into this small group. It is essential when obtaining consent to explain that some side-effects may not occur for months or years after treatment, that they are hard to predict, and to discuss any risk that might have significant implications for the patient even if the risk of occurrence is small. Some patients may wish to understand why late reactions occur.

The concept of consequential late effects may be easier to understand for the patient as the severity of the late reaction is influenced by the severity of the acute reaction, and one may merge into the other. The possibility of consequential effects should be discussed where relevant.

3. Radiation therapy and second cancers Radiation therapy kills cells by damaging the genetic code or DNA so that the cells cannot grow and reproduce. In some cells, the DNA damage does not cause cell death but makes a mutation or change in the code the DNA carries. If the mutation affects cell growth it may cause that cell to proliferate more than it should, which is the fundamental process leading to cancer development. Generally, a cancer arising as a result of radiation therapy occurs years after the original treatment.

Patients having radiation therapy to treat cancer may develop a second cancer as a direct result of the radiation. This is a small risk, which generally is greatly outweighed by the benefit of having the first cancer cured. The younger the person is at the time of radiation therapy, the more vulnerable the body is. Therefore, this is a particularly relevant issue when considering the use of

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radiation therapy in children undergoing treatment for cancer in whom the tissues may be especially vulnerable, and for all those with a long life expectancy after treatment.

Many treatment protocols for childhood cancer have been modified over recent decades to reflect the need to minimise treatment-related carcinogenesis. When radiation therapy is recommended it is generally accepted that the potential benefits greatly outweigh the risk of second malignancy. It should also be noted that childhood cancer may arise in individuals with a particular genetic susceptibility to malignancy, who may develop second malignancies whether or not they receive radiation therapy. In adults the risk of developing another malignancy unrelated to the radiation therapy is significantly higher than the risk of developing a radiation-induced cancer.

Estimates of the risk of a second cancer caused by radiation therapy vary with age at treatment. Examples for adults treated later in life would range from 1 in 300 to 1 in 70, depending on how long the patient survives after the original diagnosis. Estimates of second malignancies in children cured of their first malignancy are in the order of 5% or more.

Treatment of radiation-induced malignancies is based on the same considerations as treatment for other cancers, with the obvious proviso that those occurring in-field cannot be re-irradiated.

4. Fertility Providing accurate and sensitive information regarding issues of fertility is essential when obtaining consent for a procedure that may have an impact on fertility. Discussions should take place in plenty of time before commencing treatment that might reduce fertility, to give the patient enough time to consider the impact, whether they wish to proceed with treatment, and whether they would be suitable for sperm or ovarian tissue preservation prior to therapy. Discussions with the partner are also important.

In women, depending on age, fractionated doses as low as 10 Gy may induce ovarian failure, with resulting sterility and induction of menopause. The patient should be advised of the likely outcome, but cautioned that sterility is not guaranteed even at higher doses of radiation therapy, so that appropriate precautions can be taken if required to prevent an unwanted pregnancy. Advice should also be given about management of premature menopause.

For men, pelvic radiation therapy results in scattered radiation that may be sufficient to reduce the sperm count and motility temporarily, and may have some effect on Leydig cell function and semen quality. Use of external testicular shielding will reduce the dose, but much of the scatter is internal. Advice should include a recommendation to prevent conception for at least six months following the end of treatment (allowing a period of more than two cycles of spermatogenesis to occur). It should be emphasised that conception only requires one motile and intact sperm. This is also relevant for men who have a low sperm count prior to treatment (e.g. those with testis cancer), in that in vitro fertilisation (IVF) is possible for those with low counts.

There is no evidence to suggest that a fetus conceived during or immediately after the delivery of radiation therapy to either partner has a greater risk than the general population of suffering a germ-line or somatic mutation or congenital abnormality. It should be explained that if a child is born with an abnormality, it is unlikely (but not impossible) to be related to the radiation therapy, as gametes exposed to radiation are generally destroyed. It is for the patients to make their choices and take responsibility for using contraception if they have been given this advice. It is essential to document the advice given.

5. Combined chemoradiation and other combined modalities Contemporary practice increasingly incorporates the use of combined modality therapies, particularly chemoradiation, but combinations of radiation therapy with surgery and triple modality approaches are now also commonplace. As the biological moieties become more established the complexity of multi-modal approaches will increase further. Combination treatments may be delivered concurrently or sequentially: as new agents are introduced, the investigation of how best to schedule them in relation to radiation therapy is critical to the development of our practice.

The combined approaches have the potential to increase morbidity overall through the toxicities associated with the second modality in its own right as well as those arising from combining the

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various agents. Detailed explanation of the specific morbidities arising from chemotherapy or surgical treatment should be undertaken by the particular specialist concerned, with the radiation oncologist providing information about the potential effects of combined treatment on the patient’s experiences. These should also be discussed in the context of the potential gains the patient has from undergoing combined modality treatment rather than radiation therapy alone.

6. Specific effects Understanding and discussing particular side effects that have the potential to be devastating to an individual patient is critical to obtaining valid consent to proceed with treatment. Very rarely would these be early and self-limiting side effects, so the emphasis should be placed on those that the patient would potentially live with long term. The level of risk should be described qualitatively: uncommon, very uncommon, rare and extremely rare, and it should be explained that the precise risk is difficult to predict and may change with time. In general terms these categories would equate to 5-10%, a few per cent, less than 1% and much less than 1%.

Specific examples include, but are not limited to:

• Ocular damage • Other central neurological damage – particularly relevant for a potential long-term survivor • Spinal cord damage • Peripheral neurological damage such as neurovascular-mediated impotence in prostate

cancer patients, brachial plexus in breast cancer patients • Incontinence • Lymphoedema • Lung damage: athlete • Laryngeal toxicity: opera singer • Pelvis: women of child-bearing age—either infertility or risk of continued fertility, premature

menopause; men—risk of infertility and fertility.

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APPENDIX B – LITERATURE REVIEW OF COMMUNICATION STRATEGIES PRINCIPLES AND STRATEGIES FOR MAKING RADIATION THERAPY PATIENTS BETTER INFORMED

Introduction This appendix summarises some of the recent literature in terms of potential methodologies for improving the patient experience, better meeting information needs and making the process of informed consent more realistic and appropriate for patients and their families. The Faculty of Radiation Oncology informed consent document covers the broad principles related to informed consent. This appendix does not represent a definitive solution or set of recommendations in relation to doctor patient communication but represent a brief summary of recent literature in terms of potential options open to departments and the team of health professionals caring for cancer patients. Most literature relates to brief prospective surveys, qualitative research, opinions and review articles. No one solution is appropriate for anyone patient, department, region or clinical scenario. Different departments will have different resources and be potentially able to adopt and / or adapt some of the methodologies mentioned in these articles. Four major themes emerge from the literature.

1. Many cancer patients feel information needs have not been met. 2. Information needs are variable according to the individual patient. 3. A variety of information aides have been shown to be useful. 4. Postgraduate training to develop communication skills may be required.

Reviews Several authors have reviewed the evidence that good quality communication with the cancer patient and family is crucial in achieving good outcomes of cancer care, quality of life and patient satisfaction. Although it is now increasingly rare to limit disclosure of the cancer diagnosis and appropriate prognostic information, many cancer patients still feel dissatisfied with the amount and quality of information they receive. Additionally, many feel that they are unable to participate to the extent that they would like to, regarding decisions about their own care.(19-24)

Barnett et al conducted a prospective study of 82 adults prior to radiotherapy assessing their information needs.(25) They concluded that information needs very widely and that prediction of how much information patients felt they needed before giving informed consent was difficult. They recommended a tailored patient-centred approach.

Other patient surveys demonstrated similar variation in information needs with few specific recommendations emerging.(26-28)

Fallowfield et al reported on 2231 patients in the UK and found that 87% preferred to have as much information as possible, whether good or bad.(29) Greater than 90% of patients said that they would like to have information about all possible treatments, all possible side-effects, and how their treatments worked.

Jefford and Tattersall have summarised the consequences of under-informing, the benefits of good information and discussed many available strategies in an excellent review of the literature.(21)

Improving communication skills There is now a broad evidence base and understanding that Communication Skills Training (CST) can be taught, both an undergraduate and postgraduate level. A number of published models have sought to address this issue. The Memorial Sloan Kettering Cancer Centre has published on its Comskil model, which exactly defines the important components of the consultation and interaction.(30-33)

Coulter, Entwistle and Gilbert have developed a simple and practical checklist of components to follow to provide appropriate communication and content for cancer patients.(34)

Fallowfield et al reported on a randomised trial involving 160 UK oncologists given structured feedback, videotape review, role play, interactive group demonstrations and facilitated discussions. They demonstrated that relatively short training courses can improve several measures of key communication skills.(29)

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Improvements in communication content have also been identified by Shakespeare et al in relation to risk estimates of late effects.(16)

Timmermans et al reported on a group of eight radiation oncologists and 160 patients in an interventional survey where radiation oncologists were trained to use specific communication behaviours.(35) The Roter Interaction Analysis System demonstrated that communication training and feedback did improve (RIAS) scores.

Content communication methodology Gysels and Higginson undertook a comprehensive review of nine randomised trials investigating the use of videotapes and available computer technologies in North America, the UK and Australia.(36) Not all studies showed benefit with patient satisfaction; however, there was a trend to improve knowledge and satisfaction. Whilst some authors recommend the use of computer-based information and decision aids, others recommend the use of consultation audio recording as a means of increasing factual content, improving recall, and allowing verbal information dissemination beyond the confines of the consultation room. Provided technology barriers, privacy aspects, and appropriateness of content is assured, offering patients and their families the latter option would seem reasonable.(37)

A low tech decision board for assisting patients in deciding on breast cancer treatment options was reported in the context of randomised trial by Whelan et al demonstrating high knowledge scores and less decisional conflict.(38)

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REFERENCES 1. NHMRC. General guidelines for medical practitioners on providing information for patients.

1993. 2. General Medical Council. Seeking patients' consent: The ethical considerations 1998 [cited

2009 June 24]. Available from: http://www.gmc-uk.org/standards/consent.htm. 3 Medical Board of Australia’s Good Medical Practice: A Code of Conduct for Doctors in Australia

MBA 2014 4. Trotti A, Chin L. Adverse effects: A Pandora's box for oncology. Int J Radiat Oncol Bio Phys.

2002;54(3):642-6. 5. Rainey L. Effects of preparatory patient education for radiation oncology patients. Cancer.

1985;56:1056-61. 6. McDaniel R, Rhodes V. Development of a preparatory sensory information videotape for

women receiving chemotherapy for breast cancer. Cancer Nursing. 1998;21:143-8. 7. D'haese S, Vinh-hung V, Bijdekerke P, Spinnoy M, De Beukeleer M, Lochie N, et al. The effect

of timing of the provision of information on anxiety and satisfaction of cancer patients receiving radiotherapy. J Cancer Educ. 2000;15(4):223-7.

8. Anderson B, Karlsson J, Andersson B, Tewfik H. Anxiety and cancer treatment: Response to stressful radiotherapy. Health Psychol. 1984;3:535-51.

9. Frith B. Giving information to radiotherapy patients. Nurs Stand. 1991;34:33-5. 10. Häggmark C, Bohman L, Ilmoni-Brandt K, Näslund I, Sjödén P-O, Nilsson B. Effects of

information supply on satisfaction with information and quality of life in cancer patients receiving curative radiation therapy. Patient Educ Couns. 2001;45(3):173-9.

11. Poroch D. The effect of preparatory patient education on the anxiety and satisfaction of cancer patients receiving radiation therapy. Cancer Nursing. 1995;18:206-14.

12. Thomas R, Brown C, Dalton L, Welton S, Stockton D. Anxiety and depression--effect on patients' preferences for information following a diagnosis of cancer. Annals of Oncology. 1998;9((Suppl 4)):141.

13. White C, Mason A, Feehan M, Templeton P. Informed consent for percutaneous lung biopsy: comparison of two consent protocols based on patient recall after the procedure. Am J Roentgenol. 1995;196(5):1139-42.

14. Kessels R. Patients’ memory for medical information. Journal of the Royal Society of Medicine. 2003;96(5):219-22.

15. Sherlock A, Brownie S. Patients’ recollection and understanding of informed consent: a literature review. ANZ J Surg. 2014;84(4):207-10.

16. Shakespeare T, Dwyer M, Mukherjee R, Yeghianian-Alvandi R, Gebski V. Estimating risks of radiotherapy complications as part of informed consent: The high degree of variability between radiation oncologists may be related to experience. Int J Radiat Oncol Bio Phys. 2002;54(3):647-53.

17. Australian Medical Association, Guidelines for Doctors on Managing Conflicts of Interest in Medicine AMA 2018

18 Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008;9(5):485-93.

19. Baile W, Aaron J. Patient-physician communication in oncology: Past, present and future. Curr Opin Oncol. 2005;17(4):331-5.

20. Brédart A, Boulec C, Dolbeault S. Doctor-patient communication and satisfaction with care in oncology. Curr Opin Oncol. 2005;17(4):351-4.

21. Jefford M, Tattersall M. Informing and involving cancer patients in their own care. Lancet Oncol. 2002;3(10):629-37.

22. Salminen E, Vire J, Poussa T, Knifsund S. Unmet needs in information flow between breast cancer patients and their spouses, and physicians. Support Care Cancer. 2004;12(9):663-8.

23. Schäfer C, Herbst M. Ethical aspects of patient information in radiation oncology. An introduction and a review of the literature. Strahlenther Onkol. 2003;179(7):431-40.

24. Simes R, Tattersall M, Coates A, Raghavan D, Solomon H, Smartt H. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. Br Med J (Clin Res Ed). 1986;293(6554):1065-8.

25. Barnett G, Charman S, Sizer B, Murray P. Information given to patients about adverse effects of radiotherapy: A survey of patients' views. Clin Onocol. 2004;16(7):479-84.

26. Pour-Haring H, Volleritsch C, Roth R. [Patient information in radiooncology: Information seeking behaviour and patient characteristics]. Wien Med Wochenschr. 2009;159(5-6):148-55.

http://www.gmc-uk.org/standards/consent.htm

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27. Schäfer C, Dieti B, Putnik K, Altmann D, Marienhagen J, Herbst M. Patient information in radiooncology: Results of a patient survey. Strahlenther Onkol. 2002;178(10):562-71.

28. Foote R, Brown P, Garces Y, Okuno S, Miller R, Strome S. Informed consent in advanced laryngeal cancer. Head Neck. 2007;29(3):230-5.

29. Fallowfield L, Jenkins V, Farewell V, Saul J, Duffy A, Eves R. Efficacy of a Cancer Research UK communication skills training model for oncologists: A randomised control trial. Lancet. 2002;359(9307):650-6.

30. Brown R, Byland C. Communication skills training: Describing a new conceptual model. Acad Med. 2008;83(1):37-44.

31. Brown R, Byland C, Eddington J, Gueguen J, Kissane D. Discussing prognosis in an oncology setting: Initial evaluation of a communication skills training module. Psycho-oncology. 2010;19:408-14.

32. Byland C, Brown R, Gueguen J, Diamond C, Bianculli J, Kissane D. The implementation and assessment of a comprehensive communication skills training curriculum for oncologists. Psycho-oncology. 2010;19:583-93.

33. Schofield N, Green C, Creed F. Communication skills of health-care professionals working in oncology--can they be improved? Eur J Oncol Nurs. 2008;12(1):4-13.

34. Coulter A, Entwistle V, Gilbert D. Sharing decisions with patients: Is the information good enough? BMJ. 1999;318(7179):318-22.

35. Timmermans L, van der Maazen R, van Spaendonck K, Leer J, Kraaimaat F. Enhancing patient participation by training radiation oncologists. Patient Educ Couns. 2006;63(1):55-63.

36. Gysels M, Higginson I. Interactive technologies and videotapes for patient education in cancer care: Systematic review and meta-analysis of randomised trials. Support Care Cancer. 2007;15(1):7-20.

37. Tattersall M, Butow P. Consultation audio tapes: An underused cancer patient information aid and clinical research tool. Lancet Oncol. 2002;3(7):431-7.

38. Whelan T, Levine M, Willan A, Gafni A, Sanders K, Mirsky D, et al. Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: A randomized trial. JAMA. 2004;292(4):435-41.

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Guidelines for Informed Consent - RANZCR

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