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      Survey of healthcare professionals’ practices, expectations, and attitudes towards provision of patient information leaflets in Thailand

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          Patient information leaflets: informing or frightening? A focus group study exploring patients’ emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices

          Background The purpose of patient information leaflets (PILs) is to inform patients about the administration, precautions and potential side effects of their prescribed medication. Despite European Commission guidelines aiming at increasing readability and comprehension of PILs little is known about the potential risk information has on patients. This article explores patients’ reactions and subsequent behavior towards risk information conveyed in PILs of commonly prescribed drugs by general practitioners (GPs) for the treatment of Type 2 diabetes, hypertension or hypercholesterolemia; the most frequent cause for consultations in family practices in Germany. Methods We conducted six focus groups comprising 35 patients which were recruited in GP practices. Transcripts were read and coded for themes; categories were created by abstracting data and further refined into a coding framework. Results Three interrelated categories are presented: (i) The vast amount of side effects and drug interactions commonly described in PILs provoke various emotional reactions in patients which (ii) lead to specific patient behavior of which (iii) consulting the GP for assistance is among the most common. Findings show that current description of potential risk information caused feelings of fear and anxiety in the reader resulting in undesirable behavioral reactions. Conclusions Future PILs need to convey potential risk information in a language that is less frightening while retaining the information content required to make informed decisions about the prescribed medication. Thus, during the production process greater emphasis needs to be placed on testing the degree of emotional arousal provoked in patients when reading risk information to allow them to undertake a benefit-risk-assessment of their medication that is based on rational rather than emotional (fearful) reactions.
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            Patient information leaflets for medicines: using consumer testing to determine the most effective design.

            Comprehensive medicine information leaflets for patients are now mandatory across the European Union. In 1997, the European Commission (EC) proposed a prescriptive 'model' for the leaflets and a method for consumer testing. This exploratory study compared consumers' ability to use a leaflet based on the EC model leaflet and an alternative leaflet based on best practice in information design (Mark II). The leaflets were tested in two matched groups of 20 consumers, who were required to find, and understand, 15 pieces of information in the leaflets. The target that each question should be answered correctly by 16 out of 20 consumers, was achieved for three of the 15 points in the EC leaflet, compared with eight in the Mark II leaflet. Open questioning confirmed the problems with the EC leaflet, including a failure to understand key concepts about medicine interactions and contraindications. This research demonstrates the benefits of consumer testing, ensuring that leaflets are patient-orientated. A rigid model leaflet would prevent these benefits from being utilised.
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              How best to use and evaluate Patient Information Leaflets given during a consultation: a systematic review of literature reviews

              Abstract Background In the past, several authors have attempted to review randomized clinical trials (RCT) evaluating the impact of Patient Information Leaflets (PILs) used during a consultation and draw some general conclusions. However, this proved difficult because the clinical situations, size and quality of RCTs were too heterogeneous to pool relevant data. Objective To overcome this 30‐year stalemate, we performed a review of reviews and propose general recommendations and suggestions for improving the quality of PILs, how to use them and methods for evaluating them. Methodology We searched five databases for reviews, systematic reviews and meta‐analyses describing PILs. We drew general and condition‐linked conclusions concerning the impact of PILs. Checklists summarize criteria for quality PILs, and ways of using and evaluating them. Results Of 986 articles found, 24 reviews were pertinent; the five oldest considered the impact of PILs irrespective of the condition the patient consulted for; the 19 more recent ones mostly addressed precise clinical situations. Discussion Whatever the clinical situation, PILs improve patients' knowledge and satisfaction. For acute conditions, in the short‐term PILs also improve adherence to treatment. For chronic diseases, invasive procedures or screening situations, their impact on adherence varies depending on the context, how the PILs are given and the invasiveness of the intervention. Conclusion PILs are considered to be very useful, especially for acute conditions where the patient is the first to suffer from lack of information. We propose checklists for writing, designing, using and evaluating PILs in RCTs to enable comparisons between different studies.
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                Author and article information

                Contributors
                (View ORCID Profile)
                Journal
                International Journal of Clinical Pharmacy
                Int J Clin Pharm
                Springer Science and Business Media LLC
                2210-7703
                2210-7711
                April 2020
                January 18 2020
                April 2020
                : 42
                : 2
                : 539-548
                Article
                10.1007/s11096-020-00965-x
                © 2020

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