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How to deal with the complexities of patient consent

As patients' needs and expectations change, what constitutes 'informed consent'? Dr Robert Thomas considers the up-to-the-minute issues

The consent process is becoming more complex and litigation-oriented in response to the changing expectations and needs of our society. The ground rules of providing information for consent are shifting from paternalism to partnership and choice. Providing individualised information relevant to patients' educational, cultural and psychological needs is now fundamental to every consultation. A wide variety of tools and resources are available to aid the consent process but require organisation, time, personnel and financial resources.

Support for doctors

The spectrum of opinion on the level and style of information required for informed consent still ranges from the 'ignorance is bliss' to the 'knowledge is power' protagonists. Doctors walk a daily tightrope between giving too much information and appearing callous and insensitive, or withholding sensitive information and being accused of paternalism.

Doctors frequently rely on their medical and communicational skills and depth of experience to individualise the level and style of information each patient receives to ensure informed consent. Despite this, a number of large retrospective surveys have demonstrated high levels of dissatisfaction among patients and their relatives with the information they received following a major illness, particularly within the emotive area of cancer1.

This was not solely due to the paucity of quality-controlled information strategies within hospital clinics but reflects the lag in clinical attitudes in line with the patients' ever-increasing expectations2.

Although the NHS executive 2001 patient survey showed some significant improvements, NICE aims to plug this gap with the Supportive and Palliative Care guidance document due to be published early in 20043.

This summarises the available published literature and offers

practical advice to working clinicians. Although it has a cancer bias, its recommendation could be universally helpful to all health professionals who communicate with patients at any stage in the information and consent process.

Consent is a patient choice

Despite its two weighty volumes the discerning reader will quickly realise the fundamental premise is patient choice ­ choice, not only on the level of information patient should receive, but choice of the educational format and cultural, scientific and literal style.

Many health professionals, will have to devote a great deal of time and resources to meet the new needs of patients and their carers but the NHS executive is certainly serious about their development.

Using your judgment

The skill for us, as clinicians, is to determine the level of information the patient desires. A good bet, however, is that it's more than we think, as previous studies have repeatedly demonstrated that health professionals tend to overestimate patients' understanding of their treatment options and underestimate the level of information they require4.

Furthermore, in a UK study, an information needs questionnaire was used to estimate the level of information patients wanted after their diagnosis of cancer5. Nearly 80 per cent indicated they wanted as much information as possible.

Only 20 per cent wished to have only positive information or wanted to let the doctor make decisions for them without informed input. Interestingly, in this latter group anxiety levels were lowest so the 'ignorance is bliss' dogma is apt for a minority, and therefore it is unwise to force information on this small but significant group of patients.

For example, Franz Ingelfinger, formerly editor of the New England Journal of Medicine, who himself died of carcinoma of the oesophagus, sensed 'immediate and immense relief' when he abrogated responsibility to his doctor6.

Even a signed form doesn't remove your responsibility

How can we therefore obtain consent from this small group of patients who may not have a full understanding of their treatment options? In practice of course we slide a consent form across the treatment couch and they promptly sign it without reading it. In the vast majority of patients this is the only sensible option.

Unfortunately, the law on consent guidelines issued by the Department of Health state that written consent alone does not prove the patient was fully informed. Consequently, this puts the doctor in a more vulnerable position. If the outcome is less than the patient's expectations the blame is placed firmly on the doctor's shoulders, often by a relative who may have even not been in the original consultation.

It is not enough just to obtain written consent alone, but clear documentation is necessary demonstrating that in-depth information was also offered.

Ongoing consent

As consent is not regarded as a one-off process, but a continual dialogue throughout the patient's management, evidence that further information was offered is required at regular intervals. The NICE recommendations even suggest clinicians write a separate letter to the patient and tape the consultations.

The wording of a separate letter has to be considered carefully by the clinician requiring extra time, not to mention secretarial and postal expense for the NHS which has to be adequately funded before the idea is universally accepted.

The benefits of taping the consultation are less clear. Although 94 per cent of patients in a study said tapes helped them remember facts they had forgotten in the interview, there was no difference in psychological distress7.

A similar benefit was found in other prospective trials but a significant minority also found the procedure interfered with the consultation. This perceived interference might be even higher outside the context of a clinical trial.

Since the publication of these papers, taping the consultation has not been universally adopted, but evidence suggests doctors should have no objection if patients take the initiative to record the session.

Empowerment

The majority of patients want enough reliable information to empower them enough to have a stake in their own management decisions. Unfortunately, time pressures and patient numbers mean consultations are short.

Combined with a lack of clear information strategies within many medical departments this means patients frequently report they are uninformed2. It is well-established that this leads on to confusion, frustration and eventually psychological morbidity.

Patients who feel disempowered with their own management decisions have lower compliance, have a higher incidents of complaint and one of the most common causes of litigation within the NHS8.

Providing the information

So how can we improve our information provision? Well, good workers need good tools. Although information materials are no substitute for good verbal discussions in conveying treatment, there is a great deal of evidence that practical information tools can facilitate the consent process.

Educational materials allow the learning process to continue after the medical consultation, away from the sterile and alien environment, in the comfort of patients' own home with family and friends. A number of large randomised trials have confirmed that educational materials improve patient understanding and improve psychological well-being.

For example, the randomised trial evaluating the CancerBacup Chemotherapy and Radiotherapy preparatory information video reported that there was a highly statistically significant improvement in treatment-associated anxiety and depression in the video group compared with controls9.

Within the 220 patients, evaluated satisfaction was greatly increased in the group that received more information. Video tapes have the ability to combine the written word with vision and sound and hence can potentially provide good-quality information in a short period of time, in a format patients enjoy.

The challenge for health professionals is to ensure there are sufficient quantities to give to all patients at the appropriate stage in their management.

Evidence of benefit has also been found for written materials: in two other prospective trials a preparatory booklet significantly reduced anxiety in patients about to undergo surgical procedures including colonoscopy and inguinal hernia repair10.

A number of useful guidelines are now available to help to produce written materials relevant to patients' needs in a clear, readable and helpful manner. The most noticeable of these is produced by the Centre for Health Information Quality which provides 12 points within a quality tool called DISCERN11.

Thorny issues in consent

Adults without capacity

No one is able to give consent to examination or treatment for an adult unable to give consent for themselves, except in particular circumstances (ie, the mental health Act 1983). However, the doctor can act in the patient's 'best interests', which consists of more than just their medical best interests. The High Court can give a ruling when there is doubt about capacity or best interests.

Adults with temporary incapacity or fluctuating capacity

The law permits necessary interventions to be made in a patient's best interests, where they have become temporarily incapable ­ for example under general anaesthetic or sedation or following a road accident. If an intervention is in the patient's interests but can be delayed until the patient recovers capacity, it must be delayed until that time. In the case of fluctuating capacity it is good practice to establish while the patient has capacity their views on any clinical intervention that may be necessary during incapacity.

Self harm

Unconscious patients should be given emergency treatment if there is any doubt as to their intentions or mental state. If a patient is able to communicate, an assessment of their mental capacity is an urgent requirement. If judged incompetent, they may be treated on the basis of temporary incapacity. Competent patients have the right to refuse life-sustaining treatment in advance. Their choice must be respected if the use of the mental health Act is inappropriate.

Gillick competence

Children under 16 who have proved a capacity to understand what is proposed in an investigation or treatment are described as 'Gillick competent'. If a patient is Gillick competent their consent is valid and parental responsibility is not required. If the decision has long-term consequences ­ as in the case of contraception ­ it is good practice to encourage the patient to inform their parents unless it is not in their best interests.

Withdrawing or withholding life-prolonging treatment

Doctors must comply if an adult with capacity refuses treatment or requests it is withdrawn (except under the terms of the mental health Act). Valid advance directives to refuse a treatment are legally binding.

Withdrawal of consent

A patient may withdraw consent at any time. This creates difficulties if this happens during the performance of an examination or treatment. In this case, the doctor will need to establish whether pain, panic or shock may have affected the patient's capacity for consent.

References

1 National Cancer Alliance.

Patient-centred cancer services? What patients say. National Cancer Alliance, 1996

2 Thomas R et al. Patient Information Materials in Oncology: Are they needed and do they work? Clin Oncol. 1999;11:225-31

3 National Institute for Clinical Excellence, www.nice.org.uk/cat.asp?c=20102

4 Lloyd A et al. Patients' ability to recall risk associated with treatment options. The Lancet, 1999;353:645

5 Meredith C et al. Information needs of cancer patients in the west of Scotland views. BMJ, 1996;313:724-6

6 Ingelfinger F. Arrogance. N Engl J Med. 1980;303:1507-11

7 McHugh P et al. The efficacy of audiotapes in promoting psychological well-being in cancer patients: a randomised controlled trial. Br J Cancer, 1995;71:388-92

8 Ombudsman. Report of the health service ombudsman. HMSO: London, 1995

9 Thomas R et al. Forewarned is forearmed ­ randomised evaluation of a preparatory information film for cancer patients. Eur J Cancer, 2000,36:52-3

10 Marteau T et al. Reducing anxiety in women referred for colposcopy using an information booklet.

Br J Health Psychol, 1996;1:181-9

11 DISCERN. An instrument for judging the quality of written consumer health information on treatment choices. Oxford: Radcliffe Medical Press, 1997

Websites for patients

www.cancerbacup.org.uk/Treatments/

Chemotherapy/Chemotherapy/Givingconsent

What patients should think about before giving their consent to chemotherapy

www.cancernet.co.uk

Information on techniques and

side-effects of cancer therapies

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