The inclusion of a headline section and information about the benefits of medicines in written medicines information.

Introduction: Criticisms of the mandated patient information leaflets (PILs) supplied with all medicines include being difficult to read and overly negative. Two adaptations suggested to address this are: 1) Inclusion of headline section 2) Inclusion of additional information about potential benefits of the medicine. Aims: To explore the impact of a headline section and benefit information in PILs on patients’ satisfaction, understanding and medicine-taking behaviour. Methods: Two scoping literature reviews informed the nature of exemplar PILs with a headline section and benefit information to be presented to medicine users. These PILs were used first in focus groups to explore opinions of the adaptions, and then the headline section was user-tested. A survey assessed the nature and availability of benefit information in current PILs. Finally an interview study explored the thoughts of actual medicine users about the inclusion of benefit information. Findings: The reviews found a small body of literature about a headline section. In contrast, there was a large body of heterogeneous research on benefit information -used to develop exemplar PILs. Focus group participants viewed headline sections positively and, when user-tested, was used about a third of the time to locate key information. Benefit information was more controversial; many struggled to understand it, with an emotional response in some, who appear to over-estimate medicine benefits. The emotional response was less pronounced in the actual-user group, although some surprise and disappointment remained at the perceived low level of benefits. Conclusions: A headline section was viewed positively, and in user testing it was used to find key information. However, perceived low level of benefit proved a significant barrier to benefit information, with some unwilling to engage with it. More research is needed to allow informing patients about both the potential benefits and harms of medicines – allowing them to make informed decisions.