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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

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          Abstract

          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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          Most cited references 40

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          Qualitative inquire and research design. Choosing among five traductions

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            Literature review: considerations in undertaking focus group research with culturally and linguistically diverse groups.

            This integrated literature review seeks to identify the key considerations in conducting focus groups and discusses the specific considerations for focus group research with culturally and linguistically diverse groups. The focus group method is a technique of group interview that generates data through the opinions expressed by participants. Focus groups have become an increasingly popular method of data collection in health care research. Although focus groups have been used extensively with Western populations, they are a particularly useful tool for engaging culturally and linguistically diverse populations. The success of focus groups in this context is dependent upon the cultural competence of the research team and the research questions. The electronic databases Medline, CINAHL, Embase, Psychlit and the Internet using the Google Scholar search engine were explored using the search terms 'focus group', 'cultural sensitivity', 'transcultural nursing', 'transcultural care', 'cultural diversity' and 'ethnic groups'. Hand searching of reference lists and relevant journals was also undertaken. English language articles were selected for the review if they discussed the following issues: (i) methodological implications of the focus group method; (ii) strengths and limitations of the focus group method; (iii) recommendations for researchers and (iv) use of the focus group in culturally and linguistically diverse groups. Conclusions were drawn from each of the articles and consensus regarding a summary of recommendations was derived from a minimum of two authors. Findings from this review revealed several key issues involving focus group implementation including recruitment, sample size, data collection, data analysis and use within multicultural populations. Strengths and limitations of the focus group method were also identified. Focus groups are a useful tool to expand existing knowledge about service provision and identify consumer needs that will assist in the development of future intervention programmes, particularly within multicultural populations. Careful planning related to methodological and pragmatic issues are critical in deriving effective data and protecting participants. Focus groups can facilitate increased understanding of perspectives of culturally and linguistically diverse groups and thereby shape clinical practice to better meet the needs of these groups.
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              Getting the focus and the group: enhancing analytical rigor in focus group research.

              In the literature on focus groups, far more attention has been devoted to how groups are organized and conducted than to issues of analysis. Although exploitation of group dynamics is touted as a virtue of focus groups, there is very little guidance in the literature with respect to how differences between group and individual discourse impact the analysis and interpretation of focus group data. In this article, the authors describe analytical challenges inherent in the interpretation of focus group data and suggest approaches for enhancing the rigor of analysis and the reliability and validity of focus group findings.
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                Author and article information

                Contributors
                Oliver.Herber@med.uni-duesseldorf.de
                verenamuelders@gmx.de
                schwappach@patientensicherheit.ch
                Petra.Thuermann@uni-wh.de
                Stefan.Wilm@med.uni-duesseldorf.de
                Journal
                BMC Fam Pract
                BMC Fam Pract
                BMC Family Practice
                BioMed Central (London )
                1471-2296
                2 October 2014
                2014
                : 15
                : 1
                Affiliations
                [ ]Institute of General Practice, Medical Faculty of the Heinrich Heine University Düsseldorf, Moorenstr. 5, Building 14.97, 40225 Düsseldorf, Germany
                [ ]School of Nursing & Midwifery, University of Dundee, 11 Airlie Place, Dundee, DD1 4HJ Scotland, UK
                [ ]Department of Clinical Pharmacology, University of Witten/Herdecke, Witten, Germany
                [ ]HELIOS Klinikum Krefeld, Hospital Pharmacy, Krefeld, Germany
                [ ]Swiss Patient Safety Foundation, Zurich, Switzerland
                [ ]Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland
                [ ]Philipp Klee Institute for Clinical Pharmacology, HELIOS Klinikum Wuppertal, Wuppertal, Germany
                Article
                1137
                10.1186/1471-2296-15-163
                4287479
                25277783
                © Herber et al.; licensee BioMed Central Ltd. 2014

                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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                Research Article
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                © The Author(s) 2014

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