Adequacy of patient consent for radiation therapy

Patients have a fundamental legal and ethical right to determine what happens to their own bodies. Valid consent to treatment is absolutely central in patient management.

The Department of Health have issued a range of guidance documents on consent and on the basis of these each trust should have a consent policy in place. This should outline the legal and practical requirements for ensuring that patients have an adequate understanding of all the treatment options, the benefits and risks of each and have been supplied with appropriate verbal and written information. A high proportion of patient complaints focus on the communication of information around treatments and there is evidence that their subsequent compliance is affected by the completeness of this process.

The standard: 

All patients undergoing interventional procedures, radiotherapy, chemotherapy or other treatment modalities should be given “sufficient information in a way they can understand to allow them to exercise their genuine right to make informed decisions about their care”. For radiotherapy, signed written consent is required and there must both be a copy of this in the patient record and a copy that the patient retains for their own records.

Target: 

100%

Indicators: 

The number of patients undergoing radiotherapy who are able to answer yes to every question on the Patient Questionnaire (see Resources).

Data items to be collected: 

1) Patient demographics including age, gender, ethnic origin, 1st language etc.

2) Signed consent form available in patient record.

3) Completeness of signed consent form and indication that copy has been given to patient.

4) Patient questionnaire (see Resources)

Suggested number: 

20 patients undergoing any particular form of radiotherapy to a specified site in a particular clinical unit, e.g. adjuvant breast radiotherapy.

• Presentation of audit findings to clinical team involved and discussion regarding:

(i) issues on missing or inadequate documentation

(ii) issues on patient questionnaire

• Ensure that new medical team members, or others who are involved in the consenting process, are fully aware of the required procedures and the importance of the process for patient satisfaction and care.

• Arrange for training in the medico-legal aspects of consent, consenting technique and the possible consequences resulting from inadequate arrangements.

• Repeat date for commencing the next audit but as the changes required are usually around training and work process, repeat after short time intervals of for example 3 or 6 months.

• Identify staff member responsible for implementing the required changes.

• Indicate date for reporting on the repeat audit.

Personnel: Departmental staff member to distribute and collect the questionnaires; staff member to extract from patient record demographic details; audit assistance to collate the results.

Estimated Time: 10 minutes per patient to extract data1 hour to collate the results

1. Coldicott Y et al. The ethics of private examinations – teaching tomorrow’s doctors. BMJ 2003; 326: 97–101.

2. Department of Health. Supporting Doctors, Protecting Patients. London: The Stationery Office, 1999.Department of Health. Consent for examination or treatment (ref 25751). Leeds: DoH, 2001.

3. Department of Health. Reference guide to consent for examination or treatment. Leeds: DoH, 2001.

4. Doyal L, Tobias JS (Eds). Informed Consent in Medical Research. London: BMJ Books, 2001.

5. General Medical Council. Good Medical Practice. London: General Medical Council, 1998.General Medical Council. Seeking Patients’ Consent: the Ethical Considerations. London: GMC, 1998.

6. Harrison A. Choice is a gift from the patient to the doctor, not the other way round. BMJ 2000; 320: 874.

7. Kravitz RL, Melnikow J. Engaging patients in medical decision making. BMJ 2001; 323: 584–585.Medical Defence Union. Consent to treatment. London: MDU, 1999.

8. Royal College of Radiologists, College of Radiographers, Royal College of Nursing and the Institute of Physics and Engineering in Medicine. Breaking the mould: roles, responsibilities and skills mix in departments of clinical oncology. BFCO(02)6. London: RCR, 2002.

9. Smith R. Informed consent: The intricacies. BMJ 1997; 314: 1059–60. See also BMJ 1997; 314: 1477–1483 and BMJ 1997; 315: 247–254.

10. Westberg K, Lynoe N, Lalos A et al. Getting informed consent from patients to take part in the clinical training of students. BMJ 2001; 323: 488.

11. Willison DJ et al. Patients’ consent preferences for research uses of information in electronic medical records: interview and survey data.BMJ 2003; 326: 373.

12. Department of Health – Good practice in consent: Achieving the NHS plan commitment to patient-centred consent practice 22.11.2001. Crown Copyright HSC 2001/023

Dr Diana Tait