Table 2.
Checklist for quality Patient Information Leaflets (PILs) according to the current literature
| Contents of PILs |
| Based on the latest evidence‐based medicine14, 15, 16 |
| Declares the objectives of the PILs (writer's intention)35 |
| Explains causes, consequences, the usual course of the condition/disease14, 15 |
| Explains the benefit/risks of a treatment, if any4, 9, 41 |
| Gives advice on what to do if a dose is missed: conduct to take30 |
| Advice on who, when and where to reconsult2, 15, 22 |
| Advice on “what to do”: lifestyle recommendations, surveillance4, 46, 49 |
| Takes into account the patient's needs according to the literature18, 19 |
| Written so that it personally addresses the reader, targeted, culturally appropriate35, 41, 50 |
| Contains easy‐to‐understand illustrations, diagrams or photographs20, 30, 41, 49 |
| Names the person who wrote the leaflet and their position |
| States date of writing and/or last update14, 15, 41 |
| Gives references to sources of the information with dates14, 41 |
| Avoids advertising or pharmaceutical brand names, uses generic names41 |
| Design of PILs |
| Favours patient interaction through questions19, 50 |
| Short format14, 15, 51 |
| Layout of information structured, presented in a logical order (paragraphs and titles)14, 19, 41 |
| Not too compact, simple presentation, avoiding colour overload in drawings and boxes15 |
| Simple vocabulary (words or group of words)14, 35, 41 |
| Simple syntax (i.e. short sentences and active tense, active sentences)14, 29, 41, 52 |
| Standard font (Arial, Times) avoiding small size (10 minimum)14, 15 |
| Use of % to express frequencies, especially for risk perception19, 52 |
| Contains a space to make notes41 |
| Other properties |
| Readability verified using a standard test14, 15, 35 |
| Critically read by at least two physicians in the discipline14, 15, 50, 53 |
| Critically read by at least two potential users to test comprehension14, 15, 35 |
| Available in electronic format to facilitate storage, update and traceability of use15, 16 |
| Freely available online15, 16 |
| Mechanism for regular update of the information and installation of literature monitoring14, 15 |
| Planned evaluation of PILs in quality RCT12, 14, 15 |