Postal consent for upper gastrointestinal endoscopy

• consent
• endoscopy
• gastroscopy

When referred by their general practitioner to an open access endoscopy service, patients will not have been seen by a gastroenterologist prior to their investigation. The information given to patients about the procedure by their own doctors is likely therefore to be varied in depth and content. Furthermore, some patients will sign consent forms without asking for additional information, especially when they have already gone to the trouble of attending the hospital. The busy clinical environment may well inhibit questions and certainly does not permit much time for deliberation. Consent given in these circumstances has been questioned by senior legal opinion and may be defective if it is not based on sufficient information.

The National Health Service Litigation Authority, through the Clinical Negligence Scheme for Trusts (CNST), seeks to raise standards in the areas of communication with patients, and in gaining informed consent to treatment. The CNST has recently published a manual of 11 principal standards which member Trusts are exhorted to meet in order to achieve a reduction in subscriptions.1

Standard 7 states that “appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought”. The rationale for this flows from the observation that “complaint or litigation is less likely to follow if patients understand to what they are consenting”. The Standard then goes on to demand that:

• consent forms conform to National Health Service Executive Guidelines on content and design;

• there is patient information available showing the risks and benefits of proposed procedures; and

• there is a policy guideline stating that consent for elective procedures is to be obtained by a person capable of performing the procedure.

English case law relating to informed consent to treatment provides that there must be prior consultation or discussion. Where this does not take place, the patient, as a matter of law, may be held as not to have consented to treatment.2 In practice, however, recent cases which have come to trial have dealt with alleged failure to disclose risks inherent in the treatment, rather than failure to consult the patient. Medical practitioners may be held negligent if they fall below the standard of care practised by a responsible body of medical opinion in drawing their patient's attention to the risks inherent in a given procedure. This is the application of the so called Bolam test to the counselling of patients.3

This approach is a pragmatic one which distinguishes English practice from other countries such as the United States. Judges here have tended to uphold a standard of care based on a responsible body of medical practice over the right of the individual patient to know of all risks.2

As a result, there is no clear guidance as to the level of risk which requires specific mention to patients. Indeed, clinical judgement may indicate that a risk discussed with one patient, may properly be considered inappropriate to mention with another in the same circumstances. For this reason judges in the landmark Sidaway case avoided laying down any specific quantification of risk, relying instead on the professional judgement of doctors and the capabilities of the particular patient concerned.4

Taking the CNST standard together with the legal principles into account, it might be suggested that all patients coming for endoscopy should have a prior consultation with a fully trained endoscopist 24 hours before being scheduled for investigation.5 This, however, is extremely expensive in terms of skilled resource, and would have the undesirable effect of reducing the availability of a heavily used service, thereby disadvantaging other patients with an urgent need. The British Society of Gastroenterology has stated that such a standard is impossible to achieve.

The use of a postal consent form coupled with an information booklet was therefore investigated as a way of reconciling the individual patient's need to be informed and to consent without being exposed to undue pressure, with the need to investigate as many patients as possible within the shortest time.