Skip to main content
SpringerLink
Log in

Design Science with a Focus on User-Centred Evaluation of Written Information

  • Chapter
  • First Online:
Communicating about Risks and Safe Use of Medicines

Abstract

Written information about medicines is commonplace and has been used worldwide for decades to communicate risks and safe use advice for medicines. This chapter describes ways to optimise these important information materials using a design science approach—a structured process that starts with awareness of a problem, continues to development of a proposal/artefact up to its evaluation, and ends with a conclusion, including increased design science knowledge and/or awareness of unresolved or new issues relevant to communication. As illustrated here, creation and optimisation of information about medicines still has much room for improvement, to be enacted considering the totality of issues integral to the quality of information—in particular comprehensibility, usability, typography and layout. In this context, the systematic use of quality criteria is highly recommended. Evaluation is a key step of the design process; therefore, several evaluation methods are presented, with consideration of their advantages and limitations. Crucially, the evaluation should focus on improving the entire information material rather than simply attaining the success criteria of a couple of tested key messages. In addition, this chapter is meant to opens eyes and provide ideas for future perspectives and pathways for user-centred information materials.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 89.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 119.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  • Aberson DHA, Bouwhuis DG (1997) Silent reading as determined by age and visual acuity. J Res Read 20:184–204

    Article  Google Scholar 

  • Aikin KJ, Swasy JL, Braman AC (2004) Patient and physician attitudes and behaviors associated with OTC promotion of prescription drugs, summary of FDA survey results. http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm600276.pdf. Accessed 28 Sept 2019

  • Amstad T (1978) Wie verständlich sind unsere Zeitungen? (How comprehensible are our newspapers?). Universität Zürich, Zurich

    Google Scholar 

  • Andreasen MS, Nielsen HV, Schrøder SO, Stage J (2007) What happened to remote usability testing?: an empirical study of three methods. Proceedings of the SIGCHI conference on Human factors in computing systems ACM DL. https://doi.org/10.1145/1240624.1240838

  • Aslani P, Hamrosi K, Feletto E, Raynor DKT, Knapp P, Huges J, et al. (2010) Investigating Consumer Medicine Information (I-CMI) Project: Australian Government, Department of Health and Ageing; The Pharmacy Guild of Australia. http://6cpa.com.au/resources/fourth-agreement/investigating-consumer-medicine-information-i-cmi-project/. Accessed 27 Sept 2019

  • Australian Government (1990) Therapeutic goods regulations. https://www.legislation.gov.au/Details/F2018C00897. Accessed 27 Sept 2019

  • Australian Government, Department of Health, Therapeutics Goods Administration (2019) Consumer information (CMI). https://www.tga.gov.au/consumer-medicines-information-cmi. Accessed 28 Sept 2019

  • Austrian Federal Office for Safety in Health Care (2013) Wie sollen medizinische Fachbegriffe für die Gebrauchsinformation übersetzt werden?—Empfohlene Übersetzungen. https://www.basg.gv.at/index.php?eID=tx_nawsecuredl&u=0&g=0&t=0&hash=7e5eb47e4c76a9e6064a5e9c87f2625100edec1f&file=fileadmin/redakteure/A/Arzneimittel/FAQ_Arzneimittel/130327_Layterms.pdf. Accessed 27 Sept 2019

  • Azodi K, Himstedt S, Hinrichs A, Krüger M, Schrader S, Schulz M (2002) Testing of the readability of package leaflets as an initial step under the pharmaceutical care initiative towards increasing the safety of medicinal products. Pharm Ind 64:1119–1125

    Google Scholar 

  • Azodi K, Himstedt S, Hinrichs A, Krüger M, Schrader S, Schulz M (2003) Test auf Lesbarkeit läuft in Apotheken. Pharm Ztg 148:3296–3298

    Google Scholar 

  • Bahri P, Castillon Melero M (2018) Listen to the public and fulfil their information interests: translating vaccine communication research findings into guidance for regulators. Br J Clin Pharmacol 84:1696–1705

    Article  PubMed  PubMed Central  Google Scholar 

  • Bauer T, Erdogan B (2012) Communication—different types of communication and channels. In: Bauer T, Erdogan B (eds) An introduction to organizational behavior (v.1.0). Creative commons, pp 347–366. https://www.academia.edu/28038582/An_Introduction_to_Organizational_Behavior_v._1.0. Accessed 27 Sept 2019

    Google Scholar 

  • Beime B (2010) BfArM im Dialog—Aktionsplan AMTS—Arzneimitteltherapiesicherheit durch bessere Lesbarkeit von Packungsbeilagen? http://www.bfarm.de/SharedDocs/Downloads/DE/Service/Termine-und-Veranstaltungen/dialogveranstaltungen/dialog_2010/100414/12_Beime.pdf?__blob=publicationFile&v=2. Accessed 27 Sept 2019

  • Beime B, Menges K (2012) 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. Pharmaceut Reg Affairs 1:1–6

    Article  Google Scholar 

  • Bell RC, Sullivan JL (1981) Student preferences in typography. J Programmed Learning Educ Technology 18:57–61

    Article  Google Scholar 

  • Bernardini C, Ambrogi V, Perioli L, Tiralti MC, Fardella G (2000) Comprehensibility of the package leaflets of all medicinal products for human use: a questionnaire survey about the use of symbols and pictograms. Pharmacol Res 41:679–688

    Article  CAS  PubMed  Google Scholar 

  • Bernardini C, Ambrogi V, Fardella G, Perioli L, Grandolini G (2001) How to improve the readability of the patient package leaflet: a survey on the use of colour, print size and layout. Pharmacol Res 5:437–443

    Article  Google Scholar 

  • Berry DC, Knapp P, Raynor DK (2002) Provision of information about drug side-effects to patients. Lancet 359:853–854

    Article  CAS  PubMed  Google Scholar 

  • Beuth Verlag (2008) ISO2471:2008–12 paper and board—determination of opacity (paper backing)—diffuse reflectance method. https://www.beuth.de/en/standard/iso-2471/115477155. Accessed 27 Sept 2019

  • Bock J (1998) Bestimmung des Stichprobenumfangs. R. Oldenbourg Verlag, München, Wien

    Google Scholar 

  • Breland K, Breland MK (1944) Legibility of newspaper headlines printed in capitals and in lower case. J Appl Psychol 28:117–120

    Article  Google Scholar 

  • Bringhurst R (2005) The elements of typographic style, 4.0 ed. Hartley & Marks, Vancouver

    Google Scholar 

  • Brunetti L, Santell JP, Hicks RW (2007) The impact of abbreviations on patient safety. Jt Comm J Qual Patient Saf 33:576–583

    PubMed  Google Scholar 

  • Burtt HE, Basch C (1923) Legibility of bodoni, baskerville roman and Cheltenham type faces. J Appl Psychol 7:237–245

    Article  Google Scholar 

  • Calamusa A, Di Marzio A, Cristofani R, Arrighetti P, Santaniello V, Alfani S et al (2012) Factors that influence Italian consumers’ understanding of over-the-counter medicines and risk perception. Patient Educ Counsel. 87:395–401

    Google Scholar 

  • Caldeira TR, Neves ERZ, Perini E (2008) Historical evolution of package inserts in Brazil. Cad Saúde Pública 24:737–743

    Article  PubMed  Google Scholar 

  • Claxton AJ, Cramer J, Pierce C (2001) A systematic review of the associations between dose regimens and medication compliance. Clin Ther 23:1296–1310

    Article  CAS  PubMed  Google Scholar 

  • Connolly GK (1998) Legibility and readability of small print: effects of font, observer age and spatial vision. Thesis, Department of Psychology, University of Calgary, Calgary

    Google Scholar 

  • Co-ordination Group for Mutual Recognition and Decentralised Procedures—Human (CMD(h)) (2016). Position paper on user testing of package leaflet—consultation with target patient groups (Compliance with article 59(3) of Council Directive 2001/83/EC); Doc. Ref: CMDh/234/2011, Rev. 01. http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Consulation_PatientsGroups/CMDh_234_2011_Rev01_2016_12_clean.pdf. Accessed 27 Sept 2019

  • Dawoodi I, Bhosale UA (2016) Evaluation of knowledge and awareness of patients about prescribed drugs and their package inserts: a cross-sectional study. Asian J Pharm 10:S96–S99

    CAS  Google Scholar 

  • Dayani MH (2000) A criteria for assessing the Persian texts’ readability. J Soc Sci Hum 10:35–48

    Google Scholar 

  • Deutsches Institut für Normung (German Institute for Standardisation) (2011) Packaging—ease of opening—criteria and test methods for evaluating consumer packaging; German version DIN CEN/TS 15945:2011. https://www.beuth.de/en/technical-rule/din-cen-ts-15945/133884093. Accessed 27 Sept 2019

  • Deutsches Institut für Normung (German Institute for Standardisation) (2013) DIN 1450: lettering—legibility. https://www.beuth.de/de/norm/din-1450/170093157. Accessed 27 Sept 2019

  • Dickinson RJ (2014) The inclusion of a headline section and information about the benefits of medicines in written medicines information. The University of Leeds, School of Healthcare, Leeds

    Google Scholar 

  • Dickinson D, Raynor DK, Duman M (2001) Patient information leaflets for medicines: using consumer testing to determine the most effective design. Patient Educ Counsel 43:147–159

    Article  CAS  Google Scholar 

  • Dickinson RJ, Raynor DK, Knapp P, MacDonald J (2016) Do patients use a headline section in a leaflet to find key information about their medicines? Findings from a user-test study. Ther Innov Regul Sci 50:581–591

    Article  PubMed  Google Scholar 

  • DiSantostefano RL, Beck M, Yeakey AM, Raphiou I, Stempel DA (2014) Patient comprehension of medication guides for asthma and chronic obstructive pulmonary disease medications. Ther Innov Regul Sci 48:574–582

    Article  PubMed  Google Scholar 

  • Dolk S, Knapp P, Maat HP, Lentz L, Raynor T (2011) Headline section in patient information leaflets: does it improve reading performance and perception? Information Design Journal 19:46–57

    Article  Google Scholar 

  • Dowse R, Ehlers M (2004) Pictograms for conveying medicine instructions: comprehension in various south African language groups. S Afr J Sci 100:687–693

    Google Scholar 

  • East African Community Secretariat (2014) The Compendium of medicine evaluation and registration for medicine regulation harmonization in the East African Community—Document no: EAC/TF-MED/MER/FD/COM/N1R0. https://apps.who.int/medicinedocs/documents/s22312en/s22312en.pdf. Accessed 29 Sept 2019

  • Ekstrom I (1993) Printed materials for an aging population: design considerations. J Biocommun 20:25–30

    CAS  PubMed  Google Scholar 

  • Ellliot AJ, Covington MV (2001) Approach and avoidance motivation. Educ Psychol Rev 13:73–92

    Article  Google Scholar 

  • Eurasian Economic Commission Council (2016) On the rules of marketing authorization and assessment of medicinal products for medical use, Resolution No. 78. http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Documents/EEC%20Decision%2078_Rules%20of%20authorization%20and%20assessment%20of%20medicinal%20products%20for%20human%20use_eng.pdf. Accessed 27 Sept 2019

  • European Commission (1998) A guideline on the readability of the label and package leaflet of medicinal products for human use, Brussels. http://www.pharma-eu.com/pdfs/Guideline%20on%20Readbaility%20EMEA.pdf. Accessed 27 Sept 2019

  • European Commission (2009) Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Brussels, Rev. 1. http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf. Accessed 27 Sept 2019

  • European Commission (2017) Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. http://ec.europa.eu/health/sites/health/files/files/documents/2017_03_report_smpc-pl_en.pdf. Accessed 28 Sept 2019

  • European Medicines Agency (2007) Minutes of the fourth meeting of the EMEA human scientific committees’ working party with patients’ and consumers’ organisations (PCWP). https://www.paint-consult.com/fileadmin/editorial/downloads/z_textverlinkungen/guideline-einfluss/haeufigkeitsangaben_nebenwirkungen/EMEA_new_wording_for_section_4.pdf. Accessed 27 Sept 2019

  • European Medicines Agency (2017) EMA action plan related to the European Commission’s recommendations on product information. https://www.ema.europa.eu/documents/other/european-medicines-agency-action-plan-related-european-commissions-recommendations-product_en.pdf. Accessed 12 Oct 2019

  • European Medicines Agency (2019) Product information templates: centralised procedures—version 10.1; MR/DC/Referral procedures—version 4.1, 2020. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59. Accessed 6 Mar 2020

  • European Medicines Agency, Heads of Medicines Agencies (2019) Guideline on good pharmacovigilance practices (EU-GVP). EMA, Amsterdam

    Google Scholar 

  • European Medicines Agency, Heads of Medicines Agencies, European Commission (2019a) Electronic product information for human medicines in the EU—draft key principles; A joint EMA-HMA-EC collaboration; EMA/849614/2018. https://www.ema.europa.eu/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-draft-key-principles_en.pdf. Accessed 28 Sept 2019

  • European Medicines Agency, Heads of Medicines Agencies, European Commission. (2019b) Electronic product information for medicines in the EU—report from an EMA-HMA-EC workshop held on 28 November 2018. https://www.ema.europa.eu/documents/report/report-european-medicines-agency-ema/heads-medicines-agencies-hma/european-commission-ec-workshop-electronic-product-information-epi_en.pdf. Accessed 28 Sept 2019

  • European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (2020) The European Union electronic Register of Post-Authorisation Studies (EU PAS register). http://www.encepp.eu/encepp/studiesDatabase.jsp. Accessed 28 Sept 2019

  • Federal Institute for Drugs and Medical Devices (2013) FAQ Packungsbeilagenprüfung—Welche Methoden sind vom BfArM für die Durchführung einer solchen Untersuchung akzeptiert? https://www.bfarm.de/DE/Service/FAQ/_functions/Arzneimittelzulassung/pal/_node.html. Accessed 27 Sept 2019

  • Feinstein Institute for Medical Research (2013) Human research protection program guidance document—glossary of lay terminology. http://www.feinsteininstitute.org/wp-content/uploads/2013/02/Glossary-of-Lay-Terminology_12-15-14.pdf. Accessed 29 Dec 2018

  • Feldmüller T, Wesch M, Kutscha M, Die EU (2011) Readability guideline: Auswirkungen auf die Packungsbeilage. Pharm Ind 73:441–446

    Google Scholar 

  • Felsch C (2004) Frequentielle Lesbarkeitsanalyse—Studienarbeit (frequential readability analysis—student research project). Grin Verlag für akademische Texte, Jena

    Google Scholar 

  • Flesch R (1948) A new readability yardstick. J Appl Psychol 32:221–233

    Article  CAS  PubMed  Google Scholar 

  • Foster CS (2013) An analysis of volunteer age and level of education on performance in ‘Readability’ testing for patient information leaflet. J Health Med Inform 4:2–4

    Google Scholar 

  • Franck MCJ, Foulon V, Van Vaerenbergh L (2011) ABOP, the automatic patient information leaflet optimizer: evaluation of a tool in development. Patient Educ Counsel 83:411–416

    Article  Google Scholar 

  • Friedmann CP, Romeo D, Hinton SS (1997) Healthcare decisions and product labeling: results of a consumer comprehension study of prototype labeling for proposed over-the-counter cholestyramine. Am J Med 102:50–56

    Article  Google Scholar 

  • Fuchs J (2005) Die Packungsbeilagen als ein Mittel zur gezielten information und Handlungsanleitung für Patienten—Entwicklung und Testung eines Instrumentes zur Beurteilung und Optimierung der Packungsbeilagen von Arzneimitteln [package inserts as medium to convey targeted information and directions for use to patients: developing and testing a tool to rate and optimise pharmaceutical product package inserts. Dissertation, Humboldt University, Berlin

    Google Scholar 

  • Fuchs J (2010a) The way forward in package insert user tests from a CROs perspective. Drug Inf J 44:119–129

    Article  Google Scholar 

  • Fuchs J (2010b) Patient information via package inserts within the European Union—results of the PAINT3 study. http://www.paint-consult.com/fileadmin/editorial/downloads/vortraege/PAINT-Consult_Presentation_chin_Deligation_Bonn_2010_engl.pdf. Accessed 27 Sept 2019

  • Fuchs J, Finke A (2008) Hippius M. Wie genau lassen sich Tabletten teilen? (How exact can tablets be divided?). Arzneimittel-Therapie-Kritik & Medizin und Umwelt 48:147–159

    Google Scholar 

  • Fuchs J, Hippius M (2007) Inappropriate dosage instructions in package leaflets. Patient Educ Counsel. 67:157–168

    Article  Google Scholar 

  • Fuchs J, Kutscha M (2015) How best to assess paper quality for package leaflets – weight or opacity? Pharm Ind 77:1380–1383

    Google Scholar 

  • Fuchs J, Hippius M, Schaefer M (2005) A survey of package inserts use by patients. Hosp Pharm Eur 21:29–31

    Google Scholar 

  • Fuchs J, Hippius M, Schaefer M (2006) Analysis of German package inserts. Int J Clin Pharmacol Ther 44:8–13

    Article  CAS  PubMed  Google Scholar 

  • Fuchs J, Banow S, Görbert N, Hippius M (2007) The importance of package insert information in the European Union. Pharm Ind 69:165–172

    Google Scholar 

  • Fuchs J, Heyer T, Langenhan D, Hippius M (2010a) New font size requirements in package inserts of medicines. Pharm Ind 72:2032–2036

    Google Scholar 

  • Fuchs J, Finke A, Hippius M (2010b) Ambivalent dosage instructions for children. Pharm Ind 72:606–610

    Google Scholar 

  • Fuchs J, Werner S, Scheunpflug C, Götze EA, Elsterman K, Scheffel K et al (2010c) Excessive medical information increase in package inserts. Int J Clin Pharmacol Ther 48:781–790

    Article  CAS  PubMed  Google Scholar 

  • Fuchs J, Scheunpflug C, Götze EA (2012) The influence of the European Union’s template on the use of package inserts compared with a shorter model template. PharmInd 74:126–136

    Google Scholar 

  • Fuchs J, Götze EA, Voigt C (2016) Landscape versus portrait format in package leaflets—which format is more suitable according to readability test results from the PAINT3 study? Pharm Ind 78:1174–1184

    Google Scholar 

  • Fuchs J, Kraft S, Vettermann A, Reiche M (2017) Typographic changes in package leaflets of the European Union based on the example of German versions between 2005 and 2015. Ther Innov Regul Sci 51:431–438

    Article  PubMed  Google Scholar 

  • Fuchs J, Götze EA, Voigt C (2018) Should package leaflets be coloured in the future? Pharm Ind 80:1428–1435

    Google Scholar 

  • Fuchs J, Scheunpflug C, Götze EA PAINT-consult medical term, abbreviation and symbol test results. Unpublished information

    Google Scholar 

  • Fujita PL, Machado CJS, de Olivera Teixeira M (2014) The medicine package leaflet and the regulation of its configurations in terms of form and content in Brazil. Saúde e Sociedade 23:166–180

    Article  Google Scholar 

  • Fullmann K, Blackburn DF, Fenton ME, Mansell H (2017) Readability and suitability of COPD consumer information. Can Respir J. https://doi.org/10.1155/2017/2945282

  • Garner M, Zhenye N, Francis J (2011) A framework for the evaluation of patient information leaflets. Health Expect 15:283–294

    Article  PubMed  PubMed Central  Google Scholar 

  • Gregg DG, Kulkarni UR, Vinze AS (2001) Understanding the philosphical underpinnings of software engineering research in information systems. Inform Syst Front 3:169–183

    Article  Google Scholar 

  • Gregory M, Poulten EC (1970) Even versus uneven right-hand margins and the rate of comprehension in reading. Ergonomics 13:427–434

    Article  CAS  PubMed  Google Scholar 

  • Gunning R (1952) The technique of clear writing. McGraw-Hill, New York

    Google Scholar 

  • Halliday MAK, Webster J (2006) On language and linguistics, 3rd edn. Continuum International Publishing Group, London

    Google Scholar 

  • Hamrosi KK, Raynor DK, Aslani P (2014) Enhancing provision of written medicine information in Australia: pharmacist, general practitioner and consumer perceptions of the barriers and facilitators. BMC Health Serv Res 14:1–10

    Article  Google Scholar 

  • Hartley J, Johnson M (2000) Portrait or landscape? Typographical layouts for patient information leaflets. Visible Lang 34:296–309

    Google Scholar 

  • Hartley J, Kenely J, Owen G, Truemann M (1980) The effect of headings on children’s recall from prose text. Br J Educ Psychol 50:304–307

    Article  Google Scholar 

  • Haug O, Box G, Kohn M, Streiftau N, Haseloff A (2011) Prüfung der Verständlichkeit und Lesbarkeit von Arzneimittelinformationen anhand aktuell am Markt befindlicher Packungsbeilagen. http://www.langcor.de/PDF/Packungsbeilagen-Studie-OTC-2010.pdf. Accessed 27 Sept 2019

  • Health Products Regulatory Authority (2018) Guide to labels and leaflets of human medicines. http://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0034-guide-to-labels-and-leaflets-of-human-medicines-v18.pdf?Status=Master&sfvrsn=39. Accessed 27 Sept 2019

  • Hemphill MA (1996) Note an adults’ color-emotion associations. J Genet Psychol 157:275–280

    Article  CAS  PubMed  Google Scholar 

  • Hevner AR, March ST, Park J, Ram S (2004) Design science in information systems research. Manag Inf Syst Q 28:75–105

    Article  Google Scholar 

  • Hieber C (2008) Lesbarkeitstest—Methoden, Bridging, Ausnahmen. https://www.paint-consult.com/fileadmin/editorial/downloads/z_textverlinkungen/lesbarkeitstest/AGES-Empfehlung_Lesbarkeitstest_Methoden.pdf. Accessed 27 Sept 2019

  • Hohgräwe U (1988) Verständlichkeit von Instruktionstexten und das Informationsverhalten von Arzneimittel-Verbrauchern. Wuppertal: Fachbereich 1—Gesellschaftswissenschaften der Bergischen Universität—Gesamthochschule Wuppertal

    Google Scholar 

  • Holmes G (1931) The relative legibility of black print and white print. J Appl Psychol 15:248–251

    Article  Google Scholar 

  • Humphris GM, Field EA (2003) The immediate effect on knowledge, attitudes and intentions in primary care attenders of a patient information leaflet: a randomized control trial replication and extension. Br Dent J 194:683–688

    Article  CAS  PubMed  Google Scholar 

  • IGT Testing Systems (2006) IGT Information leaflet W43, printing through (85 Shore A), IGT AIC2-5T2000, Global Standard Tester 2/3/3H. https://www.igt.nl/wp-content/uploads/W43.pdf. Accessed 27 Sept 2019

  • Institute for Safe Medication Practices (2015) ISMP’s list of error-prone abbreviations, symbols and dose designations. https://www.ismp.org/sites/default/files/attachments/2017-11/Error%20Prone%20Abbreviations%202015.pdf. Accessed 27 Sept 2019

  • Institutsrat des Schweizerischen Heilmittelinstituts (2019). Verordnung des Schweizerischen Heilmittelinstituts über die Anforderungen an die Zulassung von Arzneimitteln (Arzneimittel-Zulassungsverordnung, AMZV), 9 Nov 2001 (last update 1 Jan 2019). http://www.admin.ch/ch/d/sr/8/812.212.22.de.pdf. Accessed 27 Sept 2019

  • Jarernsiripornkul N, Phueanpinit P, Pongwecharak J, Krska J (2019) Development and evaluation of user-tested Thai patient information leaflets for nonsteroidal anti-inflammatory drugs: effect on patients’ knowledge. PLoS One 14:1–15

    Article  CAS  Google Scholar 

  • Kincaid JP, Fishburn RP, Rogers RL, Chissom BS (1975) Derivation of new readability formulas (automated readability index, fog count, and flesch reading ease formula) for navy enlisted personnel. University of Central Florida, Institute for Simulation and Training. https://stars.library.ucf.edu/cgi/viewcontent.cgi?article=1055&context=istlibrary. Assessed 18 Oct 2019

  • Knapp P, Raynor DK, Berry DC (2004) Comparison of two methods of presenting risk information to patients about the side effects of medicines. BMJ 13:176–180

    CAS  Google Scholar 

  • Knapp P, Raynor DK, Woolf L, Gardner P, McMillan B (2009) Evaluating the effects on side-effect risk estimates by people when given single- versus double-ended frequency expressions. Int J Pharm Pract 17(2):B32–B33

    Google Scholar 

  • Koo M, Krass I, Aslani P (2005) Consumer use of consumer medicine information. J Pharm Pract Res 35:94–98

    Article  Google Scholar 

  • Kopyto N, Braun-Münker M, Ecker F (2018) Importance of opening advices with novel packaging concepts. Pharm Ind 80:1123–1127

    Google Scholar 

  • Lebanese American University (2011) Medical to lay terminology. http://gsr.lau.edu.lb/irb/forms/medical_lay_terms.pdf. Accessed 27 Sept 2019

  • Lerner EB, Jehle DVK, Janicke DM, Moscati RM (2000) Medical communication: do our patients understand? Am J Emerg Med 18:764–766

    Article  CAS  PubMed  Google Scholar 

  • Lewis C, Rieman, J (1994) Task-centered user interface design: a practical introduction. http://hcibib.org/tcuid/tcuid.pdf. Accessed 18 Oct 2019

  • Mansoor L, Dowse R (2007) Written medicines information for south African HIV/AIDS patients: does it enhance understanding of co-trimoxazole therapy? Health Educ Res 22:37–48

    Article  PubMed  Google Scholar 

  • March ST, Smith GF (1995) Design and natural science research on information technology. Decis Support Syst 15:251–266

    Article  Google Scholar 

  • Martinet A, Palmer E (1967) Elements of general linguistics, 3nd edn. University of Chicago Press, Chicago

    Google Scholar 

  • Mazzullo JM, Lasagna L, Girner PF (1974) Variations in interpretation of prescription instructions—the need for improved prescribing habits. JAMA 227:929–931

    Article  PubMed  Google Scholar 

  • McAvoy DR, Pitts PJ, Holdsworth SM, Elsner MW, Dowsett SA, Rotelli MD et al (2007) A new model for communicating risk information in direct-to-consumer print advertisements. Drug Inf J 41:111–127

    Article  Google Scholar 

  • McLaughlin HG (1969) SMOG grading: a new readability formula. J Read 12:639–646

    Google Scholar 

  • Medicines and Healthcare Products Regulatory Agency (2005) Always read the leaflet—getting the best information with every medicine. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/391090/Always_Read_the_Leaflet___getting_the_best_information_with_every_medicine.pdf. Accessed 27 Sept 2019

  • Medicines and Healthcare Products Regulatory Agency (2008) Questions and answers on PLPI PIL user testing. http://webarchive.nationalarchives.gov.uk/20141205150130/http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON014586&RevisionSelectionMethod=Latest. Accessed 27 Sept 2019

  • Medicines and Healthcare Products Regulatory Agency (2012) Best practised guidance on patient information leaflets. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/328405/Best_practice_guidance_on_patient_information_leaflets.pdf. Accessed 27 Sept 2019

  • Medicines and Healthcare Products Regulatory Agency (2017) Human factors and usability engineering—Guidance for medical devices including drug-device combination products, version 1.0. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/645862/HumanFactors_Medical-Devices_v1.0.pdf. Accessed 27 Sept 2019

  • Medicines Evaluation Board (2019) Patiëntvriendelijke termen. https://www.cbg-meb.nl/binaries/college-ter-beoordeling-van-geneesmiddelen/documenten/beleidsdocumenten/2019/01/01/patientvriendelijke-termen/190628+Lijst+met+pati%C3%ABntvriendelijke+termen+voor+bijsluiter.pdf. Accessed 27 Sept 2019

  • Morrow D, von Leirer O, Altieri P, Tanke E (1991) Elder’s schema for taking medication: implications for instruction design. J Gerontol 46:378–385

    Article  Google Scholar 

  • Morrow DG, von Leirer O, Andrassy JM, Decker Tanke E, Stine-Morrow EAL (1996) Medical instruction design: younger and older adult schemas for taking medication. Hum Factors 38:556–573

    Article  CAS  PubMed  Google Scholar 

  • Moudgil T, Arora R, Kaur K (2016) Prevalance of color blindness in children. Int J Med Dental Sci 5:1252–1258

    Google Scholar 

  • National Agency for Medicines and Medical Devices of Romania (2010) HOTÃRÂREA Nr. 6/23.03.2010 referitoare la aprobarea Ghidului privind modalitatea de efectuare a consultãrii cu grupurile þintã de pacienþi în vederea elaborãrii prospectului. http://www.anm.ro/_/HCS/HCS_6_2010.rar. Accessed 16 Oct 2019

  • National Center for Education Statistics, US Department of Education, Office of Educational Research and Improvement (2002) Adult literacy in America, a first look at the findings of the National Adult Literacy Survey (NALS). https://nces.ed.gov/pubs93/93275.pdf. Accessed 18 Oct 2019

  • Nielsen J (1994) Usability inspection methods. Wiley, New York

    Book  Google Scholar 

  • Paech T, Ihnken B, Menges K, Dobmeyer T (2011) Readability of package leaflets according to age and level of education. Pharm Ind 73:1387–1398

    Google Scholar 

  • Pander Maat H, Lentz L (2010) Improving the usability of patient information leaflets. Patient Educ Counsel. 80:113–119

    Article  Google Scholar 

  • Pander Maat H, Lentz L, Raynor D (2015) How to test mandatory text templates: the European patient information leaflet. PLoS One. https://doi.org/10.1371/journal.pone.01392501-17

  • Papay J, Fritz D, Contu T, Ellis M, Debussey S (2010) Assessment of a simplified format of written patient prescription drug information. Drug Inf J 44:375–391

    Article  Google Scholar 

  • Patel VL, Branch T, Arocha JF (2002) Errors in interpreting quantities as procedures: the case of pharmaceutical labels. Int J Med Inform 65:193–211

    Article  PubMed  Google Scholar 

  • Paterson DG, Tinker MA (1929) Studies of typographical factors influencing speed of reading; II. Size of type. J Appl Psychol 13:120–130

    Article  Google Scholar 

  • Paterson DG, Tinker MA (1931) Studies of typographical factors influencing speed of reading, VI. Black type versus white type. J Appl Psychol 13:241–247

    Article  Google Scholar 

  • Paterson DG, Tinker MA (1940) How to make type readable. Harper, Oxford

    Google Scholar 

  • Paterson DG, Tinker MA (1942) Influence of size of type on eye movements. J Appl Psychol 26:227–230

    Article  Google Scholar 

  • Perry DK (1952) Speed of accuracy of reading Arabic and Roman numerals. J Appl Psychol 36:346–347

    Article  Google Scholar 

  • Pfeffers K, Tuunanen T, Rothenberger M, Chatterjee S (2008) A design science research methodology for information systems research. J Manag Inf Syst 24:45–77

    Article  Google Scholar 

  • Pickford RW (1963) Natural selection and colour blindness. Eugen Rev 55:97–101

    CAS  PubMed  PubMed Central  Google Scholar 

  • Pinero-Lopez MA, Figueiredo-Escriba C, Modamio P, Lastra CF, Marino EL (2019) Readability assessment of package leaflets of biosimilars. BMJopen 9:e024837. https://doi.org/10.1136/bmjopen-2018-024837

    Article  Google Scholar 

  • Pires C, Vigário M, Cavaco A (2015a) Graphical content of medicinal package inserts: an exploratory study to evaluate potential legibility issues. Health Inf Libr J 33:121–129

    Article  Google Scholar 

  • Pires C, Vigário M, Martins F, Cavaco A (2015b) Abbreviations and symbols in a large sample of medicinal package leaflets: automatic detection and comprehension assessment. Procedia Computer Sci 64:683–690

    Article  Google Scholar 

  • Pires C, Vigário M, Cavaco A (2015c) Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study. Sao Paulo Med J 133:91–100

    Article  PubMed  Google Scholar 

  • Pires C, Martins F, Cavaco A, Vigário M (2017a) Automatic quantification of abbreviations in medicine package leaflets and their comprehension assessment. Int J E-Health Medical Commun 8:47–64

    Article  Google Scholar 

  • Pires C, Cavaco A, Vigário M (2017b) How sociodemographic features impact subjects’ opinion on packages leaflets of medicines? Australasian Medical J 10:774–784

    Article  Google Scholar 

  • PizzolI TSD, Moraes CG, Arrais PSD, Bertoldi AD, Ramos LR, Farias MR et al (2019) Medicine package inserts from the users’ perspective: are they read and understood? Rev Bras Epidemiol 22:1–12

    Google Scholar 

  • Poulton EC (1965) Letter differentiation and rate of comprehension in reading. J Appl Psychol 49:358–362

    Article  CAS  PubMed  Google Scholar 

  • Poulton EC (1967a) Skimming (scanning) news items printed in 8-point and 9-point letters. Ergonomics 10:713–716

    Article  CAS  PubMed  Google Scholar 

  • Poulton EC (1967b) Searching for newspaper headlines printed in capitals or lower-case letters. J Appl Psychol 51:417–425

    Article  CAS  PubMed  Google Scholar 

  • Poulton EC (1969) Skimming lists of food ingredients printed in different sizes. J Appl Psychol 53:55–58

    Article  Google Scholar 

  • Poulton EC, Brown CH (1968) Rate of comprehension of an existing teleprinter output and of possible alternatives. J Appl Psychol 52:16–21

    Article  CAS  PubMed  Google Scholar 

  • Purao S (2002) Design research in the technology of information systems: truth or dare. Working paper. GSU Department of CIS, Georgia State University, Atlanta. http://www3.cis.gsu.edu/vvaishnavi/9220Sp07/Documents/truth-dare-Purao%202002.pdf. Accessed 28 Sept 2019

  • Ramadas D, Chakrabordy A, Swaroop HS, Syed F, Praveen KV (2013) Spinivas BN. A study of package inserts in southern India. J Clin Diagn Res 7:2475–2477

    Google Scholar 

  • Ramanayake BS, Liyanagoda NE, Dahanayake PK, Hemachandra MAD (2014) Do patients understand medical communication? Patients’ knowledge on anatomical location of organs in human body. Sci Res J 2:12–15

    Google Scholar 

  • Rayner K (1998) Eye movements in reading and information processing: 20 years of research. Psychol Bull 124:372–422

    Article  CAS  PubMed  Google Scholar 

  • Raynor DK (1992) Writing patient information—a pharmacist’s guide. Pharm J 254:180–182

    Google Scholar 

  • Raynor DKT, Svarstad B, Knapp P, Aslani P, Rogers MB, Koo M et al (2007) Consumer medication information in the United States, Europe and Australia: a comparative evaluation. J Am Pharm Assoc 47:717–724

    Article  Google Scholar 

  • Roethlein BE (1912) The relative legibility of different faces of printing types. Am J Psychol 23:1–36

    Article  Google Scholar 

  • Sass SM, Legge GE, Lee H-W (2006) Low-vision reading speed: influences of linguistic inference and aging. Optom Vis Sci 83:166–177

    Article  PubMed  Google Scholar 

  • Sawalha AF, Sweileh WM, Zyoud SH, Jabi SW (2008) Comparative analysis of patient package inserts of local and imported anti-infective agents in Palestine. Libyan J Med 34(4):181–185

    Article  Google Scholar 

  • Scheunpflug C (2008) Entwicklung eines Testsystems, um pharmazeutische und medizinische Fachbegriffe patientenverständlich zu erklären (development of a test system for explaining pharmaceutical and medical terms to patients). Thesis, Friedrich Schiller University, Jena

    Google Scholar 

  • Shiyanbola OO, Smith PD, Huang YM, Mansukhani SG (2017) Pharmacists and patients feedback on empirically designed prescription warning labels: a qualitative study. Int J Clin Pharm 39:187–195

    Article  PubMed  Google Scholar 

  • Shruti DA, Sarala NS, Bhuvana K (2016) Analysis of package inserts of drugs utilized in a tertiary care hospital. J Young Pharm 8:275

    Article  Google Scholar 

  • Sillo HB, Masota NE, Kisoma S, Rago L, Mgoyela V, Kaale EA (2018) Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the east African market. PLoS One 13:1–13

    Article  CAS  Google Scholar 

  • Sless D (2007) PIL testing: misapplied and out of context. Regulatory Rapporteur J 11:14–15

    Google Scholar 

  • Sless D, Shrensky R (2006) Writing about medicines for people. Communication Research Institute, Canberra

    Google Scholar 

  • Sless D, Wiseman R (1997) Writing about medicines for people: usability guidelines for consumer medicine information, 2nd edn. Department of Health and Family Services, Canberra

    Google Scholar 

  • Sojourner RJ, Wogalter MS (1997) The influence of pictorials on evaluations of prescription medication instructions. Drug Inf J 31:963–972

    Article  Google Scholar 

  • Soleimani H, Mohammadi E (2012) The effect of text typographical features on legibility, comprehension, and retrieval of EFL learners. Engl Lang Teach 5:207–216

    Google Scholar 

  • Spencer H, Reynolds L, Coe B (1974) Typographic coding in lists and bibliographies. Appl Ergonomics 5:136–141

    Article  CAS  Google Scholar 

  • Taylor WL (1953) Cloze procedure: a new tool for measuring readability. Journalism Mass Commun Q 30:415–433

    Google Scholar 

  • Tayyem MM, Takrouri MSM (2009) Patient’s safety information available on drug package inserts used in neuroanesthesia. Internet J Anesthesiol 19:1–7

    Google Scholar 

  • The European Parliament and the Council of the European Union (2004) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. OJ; L136:34–57

    Google Scholar 

  • The European Parliament and the Council of the European Union (2012) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolidated version: 16 Nov 2012). https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf. Accessed 27 Sep 2019

  • Tillmann D (2014) Metaanalyse von Lesestudien (meta-analysis of reading studies). Thesis, Faculty of Media, HTWK/Leipzig University of Applied Sciences, Leipzig

    Google Scholar 

  • Tinker MA (1963) Legibility of print. The Iowa State University Press, Iowa

    Google Scholar 

  • Tinker MA, Paterson DG (1928) Influence of type form on speed of reading. J Appl Psychol 12:359–368

    Article  Google Scholar 

  • Tinker MA, Paterson DG (1929) Studies of typographical factors influencing speed of reading, III. Length of line. J Appl Psychol 13:205–219

    Article  Google Scholar 

  • Tinker MA, Paterson DG (1931a) Studies of typographical factors influencing speed of reading, VII. Variations in colour of print and background. J Appl Psychol 15:471–479

    Article  Google Scholar 

  • Tinker MA, Paterson DG (1931b) Studies of typographical factors influencing speed of reading, V. Simultaneous variation of type size and line length. J Appl Psychol 15:72–78

    Article  Google Scholar 

  • Tinker MA, Paterson DG (1944) Eye movements in reading black print on white background and red print on dark green background. Am J Psychol 1:93–94

    Article  Google Scholar 

  • Tinker MA, Paterson DG (1949) Speed of reading nine point type in relation to line width and leading. J Appl Psychol 33:81–82

    Article  Google Scholar 

  • Tong V, Raynor DK, Aslani P (2014) Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review. Int J Clin Pharm 36:865–872

    Article  PubMed  Google Scholar 

  • Tong V, Raynor DK, Aslani P (2018) Comparative user testing of Australian and UK over-the-counter labels and leaflets for Diclofenac. Ther Innov Regul Sci 52:38–48

    Article  PubMed  Google Scholar 

  • University of Hohenheim (2010) Der Hohenheimer Verständlichkeitsindex (The Hohenheimer Comprehensibility index). https://www.uni-hohenheim.de/politmonitor/methode.php. Accessed 23 Dec 2018

  • US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health (2001) Guidance on medical device patient labeling; final guidance for industry and FDA reviewers. https://www.fda.gov/media/71030/download. Accessed 27 Sept 2019

  • US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation (2016) Applying human factors and usability engineering to medical device—guidance for industry and food and drug administration staff. https://www.fda.gov/media/80481/download. Accessed 27 Sept 2019

  • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) (2009) Guidance for industry—label comprehension studies for non-prescription drug products—draft guidance. https://www.fda.gov/media/75626/download. Accessed 27 Sept 2019

  • US Food and Drug Administration (2018) 21CFR280.20 content and format of a medication guide. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=208.20. Accessed 28 Sept 2019

  • Vaishnavi V, Kuechler W, Petter S, De Leoz G (2019) Design science research in information systems. http://desrist.org/design-research-in-information-systems. Accessed 28 Sept 2019

  • Van Aken JE (2005) Management research as a design science: articulating the research products of mode 2 knowledge production in management. Br J Manage 16:19–36

    Article  Google Scholar 

  • Van Beusekom M, Bos M, Wolterbeek R, Guchelaar H-J, van den Broek J (2015) Patients’ preferences for visuals: differences in the preferred level of detail, type of background and type of frame of icons depicting organs between literate and low-literate people. Patient Educ Counsel. 98:226–233

    Article  Google Scholar 

  • Van Beusekom MM, Grootens-Wiegers P, Bos MJW, Guchelaar HJ, van den Broek JM (2016) Low literacy and written drug information: information-seeking, leaflet evaluation and preferences, and roles for images. Int J Clin Pharm 38:1372–1379

    Article  PubMed  PubMed Central  Google Scholar 

  • Van Beusekom MM, Kerkhoven AH, Bos MJW, Guchelaar HJ, van den Broek JM (2018) The extent and effects of patient involvement in pictogram design for written drug information: a short systematic review. Drug Discov Today 23:1312–1318

    Article  PubMed  Google Scholar 

  • Van Dijk L, Monteiro SP, Vervloet M, de Bie J, Raynor DKT (2014a) Study on the package leaflets and the summary of product characteristics of medicinal products for human use—PIL-S study. http://ec.europa.eu/health/files/committee/75meeting/pil_s.pdf. Accessed 27 Sept 2019

  • Van Dijk L, Vervloet M, Monteiro SP, van der Burgt S, Raynor DKT (2014b) Feasibility and value of a possible “key information section” in patient information leaflets and summaries of product characteristics of medicinal products for human use—the PILS-BOX study. http://ec.europa.eu/health/files/committee/75meeting/pilbx.pdf. Accessed 27 Sept 2019

  • Vander Stichele RH, Van Haecht CH, Braem MD, Bogaert MG (1991) Attitude of the public toward technical package inserts for medication information in Belgium. Ann Pharmacother 25:1002–1006

    CAS  Google Scholar 

  • Vander Stichele RH, De Potter B, Vyncke P, Bogaert MG (1996) Attitude of physicians toward patient package inserts for medication information in Belgium. Patient Educ Counsel. 28:5–13

    Article  Google Scholar 

  • Vinker S, Eliyahu V, Yaphe J (2007) The effect of drug information leaflets on patient behaviour. Isr Med Assoc J 9:383–386

    PubMed  Google Scholar 

  • Weitbrecht WU, Voßkämper C (2002) Influence of the drug package information paper on compliance of neurological and psychiatric outpatients. Fortschr Neurol Psychiatr 70:178–184

    Article  PubMed  Google Scholar 

  • Wolf A (2015) An analysis and evaluation of the development of the QRD human product information template used in package leaflets—theses. University of Bonn, Bonn

    Google Scholar 

  • Wolf MS, King J, Wilson EAH, Curtis LM, Bailey SC, Duhig J et al (2012) Usability of FDA-approved medication guides. J Gen Intern Med 27:1714–1720

    Article  PubMed  PubMed Central  Google Scholar 

  • Wolf A, Fuchs J, Schweim HG (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 76:1312–1322

    Google Scholar 

  • Wolf A, Fuchs J, Schweim HG (2016) Implementation of the European QRD template in package leaflets of centralized approved medicines. Ther Innov Regul Sci 50:106–114

    Article  PubMed  Google Scholar 

  • Wolff JS, Wogalter MS (1993) Test and development of pharmaceutical pictorials. In: Monica S (ed) Human factors and ergonomics society, interface 93—humanizing technology proceedings, pp 187–192

    Google Scholar 

  • Wolka A, Simpson K, Lockwood K, Neuhauser L (2015) Focus on health literacy: recommendations to improve European Union risk management plan public summaries. Ther Innov Regul Sci 49:369–376

    Article  PubMed  Google Scholar 

  • Yu D, Park H, Gerold D, Legge GE (2010) Comparing reading speed for horizontal and vertical English text. J Vis 10:1–17

    Article  PubMed  Google Scholar 

  • Zachrisson B (1965) Studies in the legibility of printed text. Almqvist & Wiksell, Stockholm, Göteborg, Uppsala

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Drug Regulatory Affairs, Institute of Pharmacy, University of Bonn, Bonn, Germany

    Jörg Fuchs

Authors
  1. Jörg Fuchs
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jörg Fuchs .

Editor information

Editors and Affiliations

  1. European Medicines Agency (EMA), Amsterdam, Noord-Holland, The Netherlands

    Priya Bahri

Rights and permissions

Reprints and permissions

Copyright information

© 2020 Springer Nature Singapore Pte Ltd.

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Fuchs, J. (2020). Design Science with a Focus on User-Centred Evaluation of Written Information. In: Bahri, P. (eds) Communicating about Risks and Safe Use of Medicines. Adis, Singapore. https://doi.org/10.1007/978-981-15-3013-5_12

Download citation

  • DOI: https://doi.org/10.1007/978-981-15-3013-5_12

  • Published:

  • Publisher Name: Adis, Singapore

  • Print ISBN: 978-981-15-3012-8

  • Online ISBN: 978-981-15-3013-5

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation