3.4.1 EIDO patient information leaflets

NHS Ayrshire & Arran has purchased access to EIDO patient information leaflets. These are available for most common procedures at http://dc.eidohealthcare.com/library/eido_english and are the standard form of information used. Login details are available under Policies and patient information on the intranet. The leaflets have version numbers and dates, and it is essential that this information is recorded on the consent form. The leaflets are automatically updated from a central database, and are reviewed at least annually by the producer.

Feedback on the quality of information in the leaflets, and any desired changes should be discussed at the relevant department’s clinical governance meeting and fed back to the Surgical Division Clinical Governance Group, who will be responsible for communicating with EIDO.

3.4.2 Other patient information

Some departments may wish to use alternative information leaflets, either from other reputable sources such as specialist societies, or developed in-house. Prior to using such leaflets, it is essential that the department discusses and agrees on the standard leaflets to be used, at their minuted clinical governance meeting. It will be the department’s responsibility to ensure that the most up to date leaflet is used, and shared with all relevant parties, such as the pre-operative assessment team. The department will be required to maintain version control, and to review and revise the leaflet at least every three years.

Videos, audio and web-based resources should all be developed to the same standard as leaflets. Version control and regular review must also be maintained.

3.4.3 Quality of information provided

In light of the Supreme Court’s decision (Montgomery v Lanarkshire Health Board), information leaflets should contain comprehensive information on the procedure, its indications, benefits and risks and any alternatives (including no therapy).

Patients and health professionals find it difficult to understand probabilities. Although terms such as ‘common’ and ‘rare’ have technical definitions, different individual patients may interpret them very differently. Comparisons with other rare events (lightning strikes, lottery wins) are rarely helpful. Quantitative information is useful, but is not a substitute for thorough discussion and ensuring that patients understand the information.

Table of risks using standard international definitions for adverse drug reactions

Very common ≥1/10 ≥10%
Common (frequent) ≥1/100 and <1/10 1-9.9%
Uncommon (infrequent) ≥1/1,000 and <1/100 0.1-0.9%
Rare ≥1/10,000 and <1/1000 0.01-0.09%
Very rare <1/10,000 <0.01%

Visual presentation, such as risk matrices, may be helpful. In this example of a 10x10 matrix, the green squares represent patients who benefit from the procedure (14%). Patients in red suffer a severe side effect (1%), and patients in pink a moderate side effect (6%). Patients in gray neither benefit from, nor are harmed by the intervention (79%).