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After Bristol: the importance of informed consent

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VOL: 97, ISSUE: 49, PAGE NO: 32

Ann Gallagher, MA, RGN, RMN, PGCEA, is a PhD student at the University of Central Lancashire

Jean McHale, MPhil, LLB, is professor of law at the University of Leicester

The final report of the Bristol Royal Infirmary Inquiry (Kennedy et al, 2001), which was published in July this year, is arguably the most extensive and comprehensive critical review of clinical practice undertaken in England. It provides a thorough critique of the conduct of paediatric cardiac practices at Bristol Royal Infirmary between 1984 and 1995.

In an article by Dinsdale (2001), Rebecca Howard, a nurse and member of the inquiry team, is reported to have said: ‘We heard some very good things about nursing at Bristol, but what came through clearly is that there were big gaps in what people were communicating with each other.’

The report sets out a wide-ranging series of recommendations under a number of headings:

- Respect and honesty;

- A health service that is well led;

- Competent health care professionals;

- The safety of care;

- Care of an appropriate standard;

- Public involvement through empowerment;

- The care of children.

The first category, ‘respect and honesty’, focuses on partnership, keeping patients informed on treatment and care, communicating with them, support services for patients, consent to treatment and responding to the patient when things go wrong. This article focuses on the implications of the inquiry’s recommendations for nursing practice in relation to consent to treatment.

Keeping patients informed

In the past doctors took responsibility for providing information to patients/clients and gaining their consent, while nurses played a subsidiary role. Today the situation is quite different.

Given the ever-expanding scope of professional practice and increasing professional autonomy, nurses may be the sole or main clinical practitioners dealing with a particular patient. Patients may also turn to nurses for advice and clarification after a consultation with a doctor or another health professional. It is therefore vital that nurses are aware of their professional and legal obligations regarding consent to treatment.

As treatment choices/options increase, so does the range of methods of conveying information to patients. The NHS promotes the greater availability of patient information through initiatives such as NHS Direct. In the future there is also the prospect of new bodies, such as the Patient Advocacy and Liaison Service, playing a role (Department of Health, 2000).

Health care professionals cannot be regarded as simply imparters of information, while patients are not simply passive recipients. The internet and the media have contributed to patients being far more aware of the choices available to them and more fearful of the risks that may arise from clinical procedures.

The Bristol inquiry report and its recommendations need to be seen in the context of these developments. The report makes a number of specific recommendations in relation to patient information. It states, for example:

’4. Information about treatment and care should be given in a variety of forms, be given in stages and be reinforced over time.

’5. Information should be tailored to the needs, circumstances and wishes of the individual.

’6. Information should be based on the current available evidence and include a summary of the evidence and data in a form which is comprehensible to patients.

‘7. Various modes of conveying information, whether leaflets, tapes, videos or CDs, should be regularly updated, and developed and piloted with the help of patients.’

What then are the implications of these recommendations for nurses in practice?

The legal and professional context

In English law there is no right to full disclosure of all information concerning the nature and risks of treatment. To avoid liability in battery (non-consensual touching, which amounts to trespass to the person), health professionals must disclose the broad nature of the procedure to be undertaken (Chatterson v Gerson, 1981).

They are also obliged to disclose certain consequent risks of clinical procedures, and failure to do so may result in liability in negligence. However, English law has never recognised an obligation of informed consent as is recognised in other jurisdictions, such as the USA and Canada (Reibl v Hughes, 1980; Canterbury v Spence, 1972).

In Sidaway v Bethlem Royal Hospital Governors (1985), Lord Diplock stated that the level of information disclosed should follow the Bolam standard or test, which is used to determine whether clinical practice is negligent. The standard was defined in a famous case (Bolam v Friern Hospital Management Committee, 1957), which held that a doctor is not in breach of a duty of care if he or she acted in accordance with a practice accepted as proper by a responsible body of medical opinion. The standard also applies to other health care professionals. While the other members of the majority of law lords in Sidaway v Bethlem Royal Hospital Governors (1985) took slightly differing approaches, Lord Diplock’s approach was followed in Gold v Haringey Health Authority (1987).

Over time, however, the professional practice standard itself has begun to alter and the trend today is towards enhanced disclosure of information to patients (General Medical Council, 1998).

At the same time the judiciary is increasingly willing to scrutinise the responsible body of professional practice and the information that body of practice provides (see, for example, Bolitho v City and Hackney Health Authority, 1997; Smith v Tunbridge Wells Health Authority, 1994).

Recently Lord Woolf stated that where there is a significant risk which would affect the judgement of a reasonable patient then it is normally the doctor’s responsibility to inform the patient of that risk (Pearce v United Bristol Healthcare NHS Trust, 1999). This is an important statement towards enhanced disclosure.

Consent can be regarded positively as facilitating a partnership between the practitioner and the patient. But providing large quantities of information in itself does not necessarily mean that a patient can give truly informed consent to treatment. There is a difference between making information available and communicating it effectively to the patient. The Bristol inquiry’s recommendations address this issue.

Consent as a process

The Bristol inquiry report emphasises that consent can be best regarded as a process. It states that:

’24. The process of informing the patient, and obtaining consent on a course of a treatment, should be regarded as a process and not a one-off event consisting of obtaining a patient’s signature on a form.

’25. The process of consent should apply not only to surgical procedures but all clinical procedures and examinations which involve any form of touching. This must not mean more forms: it means more communication.

‘26. As part of the process of obtaining consent, except when they have indicated otherwise, patients should be given sufficient information about what is to take place, the risks, uncertainties, and possible negative consequences of the proposed treatment, about any alternatives and about the likely outcome, to enable them to make a choice about how to proceed.’

The recommendations can be regarded as enhancing and reinforcing good practice. Section 3 of the UKCC draft of an updated code of professional conduct (UKCC, 2001), which is currently under consideration, emphasises the principles of consent and adds the helpful directive that ‘patients’ treatment decisions must be recorded and communicated to all members of the team’. It also states that ‘patients have a right to make informed choices about their care’ and to receive ‘information about their condition’.

The Bristol recommendations remind us that consent is not just applicable to surgical procedures, but relates to all activities that involve ‘touching’. This includes many nursing procedures, such as assisting with washing and dressing, taking blood pressure and applying dressings.

Providing quality information and responding to questions

Recommendations 4-7 of the Bristol inquiry report suggest that information given to patients should be based on evidence. It should also be presented in different ways, at the appropriate time and with supporting materials designed in partnership with patients. Providing evidence-based information in ‘a form comprehensible to patients’ (Recommendation 6) requires a high level of competence on the part of the nurse.

It was suggested in the House of Lords in Sidaway v Bethlem Royal Hospital Governors (1985) that while there was no doctrine of informed consent in English law, patients who ask questions about their treatment should be provided with information in response to their queries. But subsequently, in Blyth v Bloomsbury Health Authority (decided in 1987, reported in 1993), the Court of Appeal took the view that a patient - ironically herself a nurse - who had asked questions about the risks of an injectable progesterone-only form of contraception was not required to be given full information in response to her queries. It was simply the case that she should be given information in accordance with the approach that a responsible body of professional practice would take in such a situation.

The Bristol inquiry report states that ‘patients should be given the opportunity to ask questions’ (Recommendation 11). The corollary of this approach is surely that they should be provided with answers. It would appear to be difficult for professionals to justify withholding information in the future.

This potential movement towards greater transparency has implications for nurses. Are they best placed to provide information and answer questions, and what skills do they require to do so? This clearly depends on the context and the particular nurse’s knowledge and experience. For example, specialist nurses are likely to have a particularly high level of knowledge and expertise in their own area of practice. As with any other area of practice, nurses should consider carefully before undertaking an expanded role. In this context, clause 6.1 of the UKCC draft code (UKCC, 2001) states: ‘To practise competently you must possess the skills and abilities required for lawful, safe and effective practice without supervision. You must acknowledge the limits of your professional competence and only undertake practice and accept responsibilities for which you are suitably skilled and experienced.’

What appears most challenging is the statement in the Bristol inquiry report that ‘information should be tailored to the needs, circumstances and wishes of the individual’ (Recommendation 5). This approach confirms the move towards greater openness and has further ramifications. It implies that nurses have a good knowledge of the patient, perhaps knowing what she or he does and does not want and/or need to know.

This is aspirational, and in principle should be applauded, but what of the practice? Nurses generally spend more time with patients than any other health care professionals and are more likely to get to know them. However, when the time available to spend with patients is limited by shorter hospital stays and staff shortages, an approach that is tailored to the individual patient may be difficult to achieve. Also, although nurses receive theoretical and practical input on developing effective communication skills in the preregistration curriculum, is this enough to satisfy the demands of the Bristol recommendations?

The report also recommends other methods to promote improved communication, such as tape-recording ‘when a diagnosis, course of treatment or prognosis is being discussed’ (Recommendation 10). While tape-recording will provide the patient with a record of what has been said, will it lead to more self-conscious and inhibited practice on the part of nurses? Tape-recording will also require the provision of ‘quiet rooms’.

There are also particular challenges in areas of health care where the information on treatments is uncertain. This has been discussed elsewhere (for example, Logan and Scott, 1996).

The Bristol inquiry report acknowledges the sometimes burdensome nature of information. Recommendation 14 states: ‘Patients should be supported in dealing with the additional anxiety sometimes created by greater knowledge.’ And recommendation 15 states: ‘Patients should be told that they may have another person of their choosing present when receiving information about a diagnosis or a procedure.’ This will require careful application.

It is undoubtedly true that certain information (for example, about a life-threatening diagnosis) may distress patients, and some may benefit from having a friend or family member present for support. However, we need to be wary of treating patients as less than autonomous individuals. What may be seen as supportive and respectful in one circumstance may be seen as patronising in another.

Conclusion

This article provides only a brief overview of some of the implications of the recommendations of the Bristol inquiry on consent to treatment. Clearly, other aspects of the law and professional guidelines also impact on this area. The most significant is the Human Rights Act 1998. This does not make health care rights explicit, but a number of articles are relevant to consent, such as the right to privacy in relation to information (Article 8) and to freedom of thought and expression (Article 10).

The practical ramifications of the Bristol inquiry can already be seen in government and professional guidelines. In a statement to the House of Commons in response to the Bristol inquiry, health secretary Alan Milburn commented that ‘informed consent must be a cornerstone of a modern health service’ (Department of Health, 2001a).

The recent ‘Good practice in consent’ guidelines from the Department of Health (2001b) provide additional general and specific advice on the practical implications of consent. The RCN’s (2001) response to the Bristol inquiry also contains examples of good practice in relation to consent and information-giving in health care. There are further issues associated with imparting information to, and gaining consent from, children and those who have diminished capacity. However, these are beyond the scope of this article.

The provision of information to patients is a cornerstone of good practice in health care. Professor Ian Kennedy has said (Donnelly, 2001): ‘It doesn’t take any say-so from Whitehall for a nurse or doctor to treat a patient with courtesy and dignity. It doesn’t take Alan Milburn to do that.’

Nurses need to ensure that they have the necessary knowledge, skills and attitudes to do this competently. They also need to be able to refer patients to the most appropriate source of further information.

Enhanced and additional training is undoubtedly necessary to ensure that the inquiry’s aims with regard to the provision of information to patients are taken forward. The Bristol recommendations are to be welcomed as an important statement reminding us how crucial it is that we effectively communicate with patients.n

- The Bristol inquiry report is available on the internet at: www.bristol-inquiry.org.uk

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