References

Below is a list of some references that relation information design with the visual design of information about medicines. This list is subdivided into Books, Articles, and Academic Theses.

Books about Information Design

Baer, K. 2008. Information Design Workbook. Beverley (MA): Rockport.

Black, A., Luna, P. Lund, O., Walker, S. 2017. Information Design. Research and practice. London: Routledge. [This volume contains three articles about ‘information for patients’.]

Coates, K., Ellison, A. 2014. An introduction into Information Design. London: Lawrence King.

Jacobson, R. 1999. Information Design. Cambridge (MA): MIT.

Katz, J. 2012. Designing Information. Human factors and common sense in information design. Hoboken (NJ): John Wiley & Sons.

Lipton, R. 2007. The practical guide to information design. Hoboken (NJ): John Wiley & Sons.

Pettersson, R. 2002. Information Design: An Introduction. Amsterdam: John Benjamins Publishing Company.

Visocky O’Grady, K., Visocky O’Grady, J. 2008. The Information Design Handbook. Mies: Rotovision.

Articles about information design of patient information.

[All publications question the quality of contents and/or design of package leaflets. There are no publications that are positive about the contents or design, and there no publications that show that package inserts have any influence on the behaviour of people.]

Beime, B., Lawrence, M., Rieke, C. 2007. User testing. The practical application of readability user tests in national and international marketing authorisation procedures. Regulatory Rapporteur (TOPRA), May 2007, pp 8 – 13.

Beime B, Menges K. Does the Requirement of Readability Testing Improve Package Leaflets? Evaluation of the 100 Most Frequently Prescribed Drugs in Germany Marketed before 2005 and First Time in 2007 or After. 2012. Pharmaceut Reg Affairs. 1: 102.

Dickinson D, Raynor DK. 2003. Ask the patients – they may want to know more than you think. British Medical Journal. 327. p 861.

Dickinson D, Raynor DK, Duman M. 2001. Patient information leaflets for medicines: using consumer testing to 530 determine the most effective design. Pat Edu Couns. 43. pp 147-159.

Dickinson, D., Teather, J., Gallina, S., Newsom-Davis, E. 2010. ‘Medicine package leaflets – does good design matter?’ Information Design Journal 18(3), pp 225-240.

Dickinson R, Raynor DK, Knapp P, MacDonald J. 2016. Providing additional information about the benefits of statins in a leaflet for patients with coronary heart disease: a qualitative study of the impact on attitudes and beliefs. BMJ Open 2016; 6: e01202000.

Dickinson R, Raynor DK, Knapp P, MacDonald J. 2017. ‘How much information about the benefits of medicines is included in patient leaflets in the european union? – a survey.’ Int J Pharm Pract. 25(2): 147-58

Dickinson R, Hamrosi K, Knapp P, Aslani P, Sowter J, Krass I, et al. 2013. ‘Suits you? A qualitative study exploring preferences regarding the tailoring of consumer medicines information.’ Int J Pharm Pract. 21(4): 207-15

Dijk L. van, Patrício Monteiro S, Vervloet M, de Bie J, Raynor DK. 2014. Study on the package leaflets and the summaries of product characteristics of medicinal products for human use – PIL-S study. European Union.

Fuchs J. 2010. The way forward in package insert user tests from a
CRO’s perspective. Drug Inform Journal. 44(2). pp 119-129.

Fuchs J, Banow S, Görbert N, Hippius M. 2007. Importance of package
insert information in the European Union. Pharm Ind. 69(2), pp 165-172.

Fuchs J, Hippius M. 2007. Inappropriate dosage instructions in package
inserts. Patient Educ Counsel. 67(1-2). pp 157-168.

Fuchs J, Scheunpflug C, Götze E. 2012. The influence of the European
Union’s QRD template on the use of package inserts compared
with a shorter model template. Pharm Ind. 74(1). pp 126-136.

Fuchs J, Werner S, Scheunpflug C, et al. 2010. Excessive medical information
increase in package inserts. Int J Clin Pharmacol Ther. 48(12). pp 781-790.

Lentz L, Pander Maat H, Dost D. 2014. An evidence-based template proposal for patient information leaflets. Inform Design Journal. 21. pp 225-243.

Notenboom K, Beers E, van Riet-Nales DA, Egberts TC, Leufkens HG, Jansen PA, et al. 2014. Practical problems with medication use that older people experience: A qualitative study. J Am Geriatr Soc. 62(12), pp 2339-44

Pander Maat H, Lentz L. 2010. Improving the usability of patient information leaflets. Pat Edu Couns. 80. pp 113-119.

Pander Maat, Lentz L, Raynor DK. 2015. How to test mandatory text templates: The European patient information leaflet. PLoS ONE 2015; 10: e0139250.

Raynor DK. 1998. The influence of written information on patient knowledge and adherence to treatment. pp 83–111 in: Myers L, Midence K (eds) Adherence to Treatment in Medical Conditions. London: Harwood Academic.

Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, et al. 2007. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 11(5):iii, pp 1-160

Raynor DK, Dickinson D. 2009. Key principles to guide development of consumer medicine information – content analysis of information design texts. Ann Pharmacother. 43. pp 700-706.

Shrank W. H. and Avorn J. 2007. Educating Patients About Their Medications: The Potential And Limitations Of Written Drug Information. Health Affairs. 26(3). pp 731-740

Sless D, Shrensky, R. 2006. Writing about Medicines for People. 3rd ed. Australian Self-Medication Industry.

Tyers A. 2008. Performance based design. Information Design Journal. 16. pp  202-215.

Wolf A, Fuchs J, Schweim H. 2012. QRD template texts intended for
package inserts: Development from the first QRD template up
to the new draft of July 2012. Pharm Ind. 74(9). pp 1540-1549.

Wolf A, Fuchs J, Schweim H. 2014. Readability of the European QRD
Template – The European QRD template version 8 in comparison
to its predecessor and a shorter model template. Pharm Ind. 76(8). pp 1312-1322.

Wolf, A., Fuchs, J., Schweim, H.G. 2016 . Implementation of the European QRD Template in Package Leaflets of Centralized Approved Medicine. Therapeutic Innovation & Regulatory Science. 50(1). pp 106-114.

 

Academic theses about package leaflets.

Gibbs, S. 1990. Informing patients about medicines: An evaluation
of prescription information leaflets in general practice. [Ph.D.
thesis] University of Southampton, Faculty of medicine.

Lenihan, Anne. 2012. Does the current way Information on medicines is provided in the “Patient Information Leaflet” format meet the needs of the patients in the United Kingdom and Germany? A thesis submitted in partial fulfillment of the requirements for the degree of TOPRA MSc in Regulatory Affairs.

Kim Notenboom. 2017. The pursuit of user-friendly medicines: Older people in the hot seat. PhD thesis. Utrecht University.

Rupf, R.E. 1991. Evaluation of patient-oriented drug information:
package leaflets as viewed by the patient and their impact on
outpatients’ behaviour during treatment. [PhD thesis] Faculty
of Philosophy and Natural Sciences, Basel.

Schickel, Ursula. 2007. The impact of the revised EU-legislation concerning particular needs of blind and partially sighted patients and user testing – a challenge for pharmaceutical companies with focus on Germany. MA-thesis. Bonn: der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn.

Vander Stichele, R. 2004. Impact of written drug information in patient package inserts: Acceptance and impact on benefit/risk. PhD thesis. Ghent University.

Waarde, K. van der. 1993. An investigation into the suitability of the graphic presentation of patient package inserts. PhD thesis. Reading University: Department of Typography & Grapic Communication.

Wolf A. 2015. An analysis and evaluation of the development of the
QRD human product information template used in package leaflets
[dissertation]. Faculty of Mathematics and Natural Sciences at the Rheinischen Friedrich-Wilhelms-University Bonn, 2015.