Table 3.
Points to consider when evaluating Patient Information Leaflets (PILs)
| Type of PILs | PILs written and designed according to a defined methodology and/or complying with the guidelines (see Table 2)12, 14, 15 |
| Way of using PILs | Hand delivered at the same time as verbal information (or, if sent prior to a consultation, by post or email, at least read together with the physician during the consultation)15, 16, 46 |
| Tailored/customized according to the patient's profile by the physician during the consultation (e.g. by underscoring certain items)10, 11, 12, 17, 18 | |
| Given at an opportune moment during the consultation9, 18 | |
| Given only if the patient wants PILs18 | |
| Study design | Randomized allocation of patients (or cluster randomization) to PILs or a control group14, 15, 29 |
| Single blind because the physician has to go through the PILs with the patient | |
| Control group without PILs (oral information alone) | |
| Outcomes | Primary outcome using one previously validated score or measure |
| Acute conditions | |
| Impact on patient | Outcomes using one or more of the main outcome measures commonly used in RCT |
| Psychic and cognitive impact | Test of comprehension/knowledge of condition |
| Satisfaction | |
| Behavioural impact | Behaviour/adherence to treatment and to advice according to the objectives of the PILs (writer's intention) |
| Reconsultation rates | |
| Therapeutic outcomes | Pain |
| Depression | |
| Anxiety | |
| Impact on physician | Number of drugs prescribed |
| Number of examinations or laboratory tests prescribed | |
| Impact on both patient and physician | Doctor Patient Communication effectiveness |
| Chronic conditions | Quality of life |
| Relapse | |
| Clinical criteria (e.g. blood pressure) | |
| Laboratory criteria (e.g. blood glucose) | |
| Appropriate timeline of measurement(s) | For an acute pathology/screening/surgery: 0 and 7–10 days after consultation |
| For a chronic disease or long‐term prescription (except cancer); D0; D7–10; M1; M3; M6; (±M12 or M24) | |
| Questionnaires | Use validated questionnaires |
| By phone or patient self‐assessment if possible, with well‐posed questions aimed at honest replies | |
| Investigator | Assessment of outcome by blinded doctor or CRA |