Educational Section

How much do healthcare professionals know about informed consent? A Bristol experience

N. K. Chadha C. Repanos

ENT Department, United Bristol Healthcare Trust, St Michael’s Hospital, Bristol, UK Correspondence to: N. K. Chadha Royal United Hospital Combe Park, Bath BA1 3NG, UK Email: neil.chadha@hotmail.com

Introduction Materials and Methods Results and Discussion Summary References

Background: It is important that healthcare professionals have a thorough knowledge of consent practice. The purpose of this study was to compare understanding against the agreed standards found in consent guidelines and UK case law. Method: Twelve ‘true or false’ questions testing knowledge of the consent process were completed by 118 healthcare professionals from the United Bristol Healthcare NHS Trust. The questions addressed areas of fundamental importance, difficult clinical situations, and common consent dilemmas. The answers were marked against pre-validated answers determined using published guidelines and case law. Results were analysed for differences between pre-determined population sub-groups. Results: A 100% response rate was achieved. Significant areas of weakness were identified including the role of consent forms, Gillick competence and mentally-ill patients. Performance was generally better by medical staff, those in surgical specialties, and more junior doctors. For example, 30.9% of doctors versus 62% of non-doctors (p=0.05) thought, incorrectly, that if an adult is unable to provide consent for an emergency procedure, the patient’s next of kin must sign the consent form. Doctors also demonstrated a greater understanding of Gillick case law and scored significantly higher than non-doctors (68% vs. 48.5%, p=0.027). Conclusions: National guidelines and case law provide the gold standard for ideal consent practice. Many healthcare professionals have either not read these documents or are unable to reliably recall them. Improvements in knowledge and practice could be possible with further education, particularly targeting those most closely involved in the consent process

INTRODUCTION

Patients have an ethical and legal right to determine what happens to their bodies. Obtaining valid consent before treatment, therefore, is fundamental in all forms of healthcare.

The NHS Plan identified the need for changes in the way in which patients are asked to give their consent to treatment, care or research, in order to ensure that the process becomes properly focused on the rights of individual patients and their relatives.¹ The importance of patient-focused consent procedures also emerged as a key theme in the Bristol Royal Infirmary Inquiry Report.² In March 2001, the Department of Health (DoH) published a reference guide to consent for examination or treatment, which summarises the current law.³

In an increasingly litigious era, it is important that all healthcare professionals who are involved in the consent process have a thorough knowledge of current guidelines and difficult issues. Current education on consent practice for healthcare professionals is of variable quality and may lead to significant gaps in understanding. This area of education will become more important as patients’ expectations rise and, therefore, we must strive to improve the consistency and quality of the consent process.

The purpose of this study was to compare the current level of understanding of healthcare professionals against the agreed standards in consent guidelines and UK case law.

MATERIALS AND METHODS

A questionnaire was designed using 12 ‘true or false’ questions testing knowledge on the consent process. The questions were carefully selected to address areas of fundamental importance, difficult clinical situations, and common consent dilemmas. The correct answers to each question were determined using the specified guidelines and the rationale is discussed below. Two independent medico-legal experts also validated questions and answers.

Healthcare professionals of the United Bristol Healthcare NHS Trust (incorporating the Bristol Royal Infirmary and Bristol Children’s Hospital) were asked to participate in the study by completing the ‘true or false’ questions. The questionnaire was provided to the subjects with an explanatory information sheet. The subjects completed the answers under observation by one of the researchers, without a time restriction and allowing no interaction with others.

A total of 118 healthcare professionals were asked to complete the questions between July and October 2003. Those asked to participate in the study were nurses (from theatres and wards), medical technical officers (ODPs), physicians, anaesthetists and surgeons. Their answers were kept confidential and anonymous. Details of profession, speciality and grade were taken to allow analysis of results.

The subjects’ answers were collated and marked against the pre-validated answers. Results were analysed to determine the proportion of overall correct answers and differences between predetermined population sub-groups. Results for the following subgroups were compared: doctors versus nondoctors; senior doctors versus junior doctors; and surgical versus non-surgical healthcare professionals. Statistical significance was tested using the Independent t-test and Fischer’s exact test.

RESULTS AND DISCUSSION

One hundred and eighteen healthcare professionals were invited to complete the questionnaire and a 100% participation rate was achieved. The sampled population consisted of 50 doctors, 61 nurses and seven ODPs.

The questions were answered poorly, given that this topic is within the remit of most healthcare professionals’ working day. The overall percentage answered correctly was 50.9%, which would be expected by chance for ‘true or false’ questions. The only sub-group to attain statistically significantly higher scores overall were doctors when compared with nondoctors (53.7% versus 47.8%, p=0.05).

The questions and answers, with explanations based on case law and published national guidelines, are as follows:

1. A signed consent form is essential before non-emergency surgery. (FALSE)³

Consent can be written or oral. It is a patient’s agreement for a health professional to provide care. A signature on a consent form does not itself prove the consent is valid. The point of the form is to record the patient’s decision, and the discussions that have taken place.3 For the consent to be valid, the patient must have received and understood sufficient information to make the particular decision.3 If consent has been validly given, the lack of a completed form is no bar to treatment.4 Therefore, a consent form is not a legal requirement before surgery, but valid consent is.

Overall, this was poorly answered with only 21.2% of respondents correct overall. However, it seems that doctors have a greater understanding than non-doctors that the consent process requires more than a signature to be valid, scoring significantly higher (30% versus 14.7%, p=0.038) (Table 2).

2. According to current DoH guidelines, all complications occurring with an incidence of at least 1% should be discussed with a patient pre-operatively. (FALSE)³

Case law determining what information is adequate is evolving. It is advisable to inform the patient of any “material” or “significant” risks in the treatment, the alternatives, and the risks incurred by doing nothing. A recent Court of Appeal judgement stated that the doctor should inform a patient of “a significant risk, which would affect the judgement of a reasonable patient”.⁴ Overall only 8.5% knew that this question was false and has no basis in case law, or published guidelines.

In the Sidaway case in 1985, the House of Lords decided that the legal standard, when deciding whether adequate information had been given to a patient, should be the same as when judging whether a doctor had been negligent in their treatment of a patient.⁵ A doctor would not be considered negligent if their practice conformed to the medical opinion of a responsible body of practitioners skilled in the field in question (known as the “Bolam test”). Whether the duty of care had been satisfied was, therefore, primarily a matter of medical opinion.⁴

Significantly, since Sidaway (1985), a number of judgements relating both to the provision of information and the standard of treatment given, have resulted in the courts in fact disagreeing with a “responsible body” of medical opinion. The courts are now the final arbiters of what constitutes responsible practice.⁴

One study attempted to quantify the incidence of complications patients wish to know as any risk greater than 1 in 1000.⁶ A case in Australia led to a successful claim against the medical practitioners when a risk of 1 in 14,000 of sympathetic ophthalmic damage was not disclosed.7 Clearly the figure of 1% has become deep-rooted in health professionals’ belief of consent law but this seems to have no legal basis.

3. A child below the age of 16 may give consent for elective surgical treatment. (TRUE)⁸

Young people aged 16 and 17 are presumed to have competence to give consent. Younger children who understand fully what is involved in the proposed procedure may also give consent (although their parents would ideally be involved). If a competent child consents to treatment, a parent cannot override that consent. Legally, however, a parent can consent if a competent child refuses.³

In English law, children are those who are under 18 years of age. However, for the purposes of giving consent, children are treated differently in law according to their age. The Family Reform Act (1969) states that the consent to treatment of a 16- or 17-year-old is to be treated like the consent of an adult.⁹ Gillick case law states that if a minor has sufficient intelligence and understanding to enable him/her to understand the treatment and implications of treatment then he/she is “Gillick competent” and may consent to treatment. A refusal to treatment may be treated differently (see question 5).

This question was answered reasonably well (56.8% correct). Doctors demonstrated greater understanding of this case law and scored significantly higher than non-doctors (68% versus 48.5%, p=0.027) (Table 2). This is in keeping with their increased responsibility in the consent process.

4. According to current DoH guidelines, the anaesthetist (not the surgeon) is responsible for seeking and documenting consent for anaesthesia, having discussed the risks and benefits. (TRUE)³

Patients should ideally receive a general leaflet and have the opportunity to discuss anaesthesia in a pre-assessment clinic or outpatients with an explanation of the choice of technique and the advantages and disadvantages of each.^3,10

If an anaesthetist is involved in a patient’s care, it is their responsibility having discussed the benefits and risks (not that of a surgeon) to seek consent for anaesthesia.3 There is a significant overlap in what constitutes an anaesthetic risk and a medical complication resulting from a combination of the surgical procedure and anaesthesia. The guidelines indicate that it is the responsibility of the anaesthetist to inform the patient of those risks directly attributable to the method and duration of anaesthesia.

Overall, this was well answered (72% correct) with anaesthetists scoring particularly well (89% correct, n=9).

5. If a competent child below the age of 16 refuses elective surgery it must not be performed. (FALSE)⁴

Where a Gillick competent child under 16 refuses treatment, such a refusal can be over-ruled either by a person with parental responsibility for the child or by the court.⁴ This is an interesting paradox in consent law, and effectively means that a Gillick competent child is able to consent to surgery against their parent’s wishes, but is unable to refuse surgery that their parent wants them to have.

Overall, less than half of participants answered this correctly. This question represents a subtlety in “Gillick” case law, and it seems this issue is less well known than the case described in question three. Doctors scored significantly higher than non-doctors (50% versus 29.4%, p=0.019) (Table 2) Junior doctors scored significantly higher than senior doctors (63% versus 30%, p=0.021).

6. According to current DoH guidelines, if a patient has signed a consent form more than six months prior to a procedure, the patient must re-sign the form for validity. (FALSE)³

If a patient gives valid consent, that consent remains valid for an indefinite duration unless the patient withdraws it. If new information regarding the proposed procedure, or a significant change in the patient’s condition become apparent then the consent procedure should be reconfirmed.⁴

A health professional involved on the day should re-sign the form to confirm that the patient still wishes to go ahead and has had any further questions answered. It is appropriate for any member of the healthcare team (for example a nurse admitting the patient for an elective procedure) to provide the second signature, as long as they have access to appropriate colleagues to answer questions they cannot handle themselves.³

This question was very poorly answered (11.9% correct). Some surgical departments have adopted a policy of formally reconsenting elective patients who have signed their consent form greater than six months previously. This policy has resulted from long waiting times between clinics and operation date, but has no basis in national guidelines or case law. Misunderstandings of the difference between local policy and national guidelines may account for the high proportion of incorrect responses.

7. If emergency surgery is needed on a child below 16 and the parents are unavailable, necessary surgery can proceed without consent being obtained. (TRUE)^7,8

Only people with ‘parental responsibility’ are entitled to give consent on behalf of their children.³ If those with parental responsibility are unavailable, no consent can be obtained, so the decision to perform surgery in an emergency is left to the responsible surgeon.

The Children Act (1989)¹¹ states that people with parental responsibility include:

• The child’s parents if married to each other at the time of conception or birth.

• The child’s mother, but not father if they were not married, unless the father has acquired parental responsibility via a court order or a parental responsibility agreement or the couple subsequently marries.

• The child’s legally appointed guardian.

• A person or local authority that the court has designated in a care order.⁴

This question was well answered (89.8% correct), which suggests a good understanding of a doctor’s duty in an emergency situation.

8. A pregnant woman has the right to refuse treatment where the treatment is intended to benefit the unborn child. (TRUE)¹²

Competent adult patients are entitled to refuse treatment, even if it would clearly benefit their health. The only exception is where treatment is for a mental disorder and the patient is detained under the Mental Health Act 1983. A competent pregnant woman may refuse any treatment, even if refusing the treatment would be detrimental to the foetus, whatever the stage of pregnancy.³

This question was well answered (83.9% correct), showing understanding of a pregnant woman’s autonomy in decisions affecting her body, and those of her unborn child.

9. Against the will of a competent mentally ill patient, you may only carry out an investigation or treatment if it is aimed at the mental condition, not at other medical problems, even if it is deemed in their best interests. (TRUE)¹³

If a competent adult makes a voluntary and informed decision to refuse treatment this decision must be respected, except in circumstances defined by the Mental Health Act 1983.^3,4

The law is clear that a mentally disordered patient is not, just by virtue of this disorder, incompetent to make treatment decisions. A patient will be competent if he or she can comprehend information presented to them in a clear way, believe it, retain it long enough to weigh it up, and make a decision.¹⁴

This question was answered correctly by only 48.3% overall. This indicates some confusion as to whether a patient with a mental illness may give, or withhold consent even if they are deemed competent to do so.

10. If an adult is unable to provide consent for an emergency procedure, the patient’s next of kin must sign the consent form, if this is possible. (FALSE)¹⁵

No one is able to sign a consent form on behalf of an adult who cannot give consent for themselves (either temporarily or permanently).^3,4

There was a large disparity between different groups’ answers to this question. This may be due to the belief that every patient requires a signature (any signature) on a consent form. However, doctors scored significantly better than non-doctors (62% versus 30.9%, p=0.05) (Table 2).

11. According to the Royal College of Surgeons (RCS) of England “Code of practice for the surgical management of Jehovah’s Witnesses” in the management of an unconscious patient who requires blood transfusion, if the patient’s relatives produce evidence of the patient’s status as a Jehovah’s Witness, a blood transfusion would be unlawful. (TRUE)¹⁶

Most Jehovah’s Witnesses carry a signed and witnessed advance directive card refusing blood and releasing clinicians from any liability arising from this refusal. Some have a more detailed directive with their general practitioner, friends or relatives.

If an adult patient can give an informed, rational opinion refusing transfusion, this should be acted upon. If they cannot, the clinical judgement of a doctor takes precedence over the opinion of relatives or associates. However, if they can produce evidence of the patient’s Jehovah’s Witnesses status, then this must be acted upon.¹⁶

Children of Jehovah’s Witnesses requiring blood transfusion present the most difficult management problem. The child’s wellbeing is paramount, and if after consultation the parents refuse blood, the doctor must use the law to protect the child’s interests, or be vulnerable to criminal prosecution. Therefore, if a child needs blood in an emergency it should be given.¹⁶

It is encouraging that this was answered reasonably well overall (62.7% correct), as this is a common dilemma encountered by healthcare professionals dealing with Jehovah’s Witnesses. However, it is a matter of concern that doctors scored significantly worse than non-doctors (48% versus 73.5%, p=0.01) (Table 2).

12. According to General Medical Council (GMC) guidelines, the responsibility for taking valid consent could be delegated to a junior doctor, provided they fully understand the procedure and the risks involved, even if they could not actually perform it. (TRUE)¹⁷

It is best for the person treating the patient to seek consent. However, it is permissible to seek consent on behalf of a colleague if the doctor can either perform, or has received training in consenting for that procedure.3 They must have sufficient knowledge of the proposed investigation or treatment, understand the risks involved, and be able to provide any information the patient may require. The consultant responsible for the patient’s care will remain ultimately responsible.¹⁷

Routine consent-taking was performed by Senior House Officers in 95% of the surveyed UK ENT departments in a recent study.¹⁸ Another study revealed that 45% of patients thought that the doctor who signed the form would be performing the surgery and 37% of juniors admitted to obtaining consent for procedures of which they had little understanding.¹⁹

This question was answered reasonably well (64.4% correct). Seniors scored significantly better than juniors (90% versus 46%, p=0.02). Therefore, many junior doctors who are responsible for taking consent do not appreciate that this aspect of their work may be medico-legally sound.

SUMMARY

Consent is incompletely understood by most healthcare professionals and yet is practiced in every patient encounter. Guidelines still provide our gold standard of ideal consent practice. A proportion of healthcare professionals have either not read these documents, or are unable to recall the main guidance given to help in difficult consent issues.

The DoH, GMC, and RCS guidelines provide a very thorough reference aid, however some reinforcement of the principles within these documents is needed.^1,3,4,17,20 Improvements in practice and knowledge should be possible with targeted educational sessions aimed at those involved in the consent process.

An increase in an already cramped medical or nursing students’ syllabus may not yield a substantial improvement in clinical consent performance. It should be expanded on as a postgraduate subject, with extra focus on special situations such as consent in children or Jehovah’s Witnesses.

This study highlights specific issues that consent education should target.

ACKNOWLEDGEMENTS

We would like to thank Rosemary Greenwood for her advice and statistical help, and also Caroline Saunders and Maria Repanos for their advice in creating the questions and researching the answers.

Copyright 27 October 2004

REFERENCES

1. Department of Health. NHS Plan. A plan for investment. A plan for reform. The Command Paper 4818 - 1. London: Department of Health, Jul. 2000. http://www.nhs.uk/ nationalplan /nhsplan.htm

2. Learning from Bristol: the report of the public inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984 -1995. Command Paper: CM 5207. Presented to Parliament by the Secretary of State for Health by Command of Her Majesty, July 2001.

3. Department of Health.Good practice in consent implementation guide: consent to examination or treatment. London: Department of Health, Nov. 2001.

4. Department of Health.Reference guide to consent for examination or treatment. London: Department of Health, Feb. 2002.

5. Sidaway v Board of Governors of the Bethlem Royal and the Maudsley Hospital (1985) 1 All ER 643.

6. Newton-Howes PA, Bedford ND, Dobbs BR, Frizelle FA. Informed consent: what do patients want to know? N Z Med J 1998; 111: 340-42.

7. McIlwain JC. Clinical risk management: principles of consent and patient information. Clin Otolaryngol 1999; 24: 255-61.

8. Gillick v West Norfolk and Wisbech Area Health Authority (1985), 3 AER 402.

9. The family Law Reform Act, Section 8(1).

10. Pre-operative assessment - the role of the anaesthetist 2001.The Association of Anaesthetists of Great Britain and Ireland. Guidelines and Publications.

11. The Children Act 1989 Section 2. 

12. St. George’s healthcare NHS Trust vs. S Fam Law (1998) 526 and 662, and MB (an adult: medical treatment) (1997) 2 FCR 541, CA.

13. Code of practice Dec 1998 Pursuant to S118 of the Mental Health Act 1983 and Regina vs. Bournewood Community and Mental Health NHS Trust ex parte L (1998) 3 All ER, 289 HL.

14. Adult: Refusal of medical treatment (1994) 1 All ER 819.

15. F (1989) WLR 1025;(1989) 2 All ER 545.

16. Code of Practice for the surgical management of Jehovah’s Witnesses. The Royal College of Surgeons of England. 1996.

17. General Medical council. Seeking patients’ consent: The ethical considerations. November 1998.

18. Chadha NK, Pratap R, Narula AA. Consent processes in common nose and throat procedures. J Laryngol Otol 2003; 117(7):536-39.

19. Houghton DJ, Williams S, Bennett JD, Back G, Jones AS. Informed consent: patients’ and junior doctors’ perceptions of the consent procedure. Clin Otolaryngol 1997; 22(6):515-18.

20. Royal College of Surgeons of England. Good Surgical Practice. September 2002.

TRUE OR FALSE QUESTIONS (Answers at end of issue)

A “Gillick-competent” child aged 12:

• is defined as a child who has sufficient intelligence to understand the potential complications of a treatment

• cannot have their consent to treatment overidden by a parent

• can have elective surgery against their own will if the parents want it

• should only be operated on in an emergency situation with parental consent

• cannot be operated on without a signed consent form

Regarding the law on Jehovah’s Witnesses and blood transfusion:

• If the relative of an unconscious adult produces evidence of a patient’s belief and wish not to receive blood, then it must not be given by law

• A surgeon may not give a transfusion to a child of Jehovah’s

Witnesses in an emergency if the parents do not consent

• If a Jehovah’s Witness adult makes an informed decision not to receive blood, this must be adhered to

• If an adult who is not a Jehovah’s Witness makes an informed decision to refuse a blood transfusion, then this does not have to be acted upon

• An adult Jehovah’s Witness may make an advanced statement stating their intent not to receive blood in an emergency in the event that they are unable to communicate. This statement must be honoured