Article published In:
Information Design JournalVol. 21:3 (2014) ► pp.225–243
An evidence-based template proposal for patient information leaflets
References
Ben-Shahar, O. Schneider, C.E
(2011) The failure of mandatory disclosure. University of Pennsylvania Law Review, 1591, 647–749.
Bergus, G. R., Levin, I. P., & Elstein, A. S
(2002) Presenting risks and benefits to patients, Journal of General Internal Medicine, 17(8), 612–617. 
Berry, D.C., Knapp, P.R, & Raynor, D.K
(2002) Is 15% very common? Informing people about the risks of medication side effects. International Journal of Pharmacy Practice, 101, 145–151.
Berry, D. C., Raynor, D. K., & Knapp, P
(2003) Communicating risk of medication side effects: An empirical evaluation of EU recommended terminology. Psychology, Health and Medicine, 8(3), 251–263.
Berry, D., Raynor, T., Knapp, P., & Bersellini, E
(2004) Over the counter medicines and the need for immediate action: A further evaluation of European commission recommended wordings for communicating risk. Patient Education and Counseling, 53(2), 129–134.
Clerehan, R., Buchbinder, R., & Moodie, J
(2005) A linguistic framework for assessing the quality of written patient information: its use in assessing methotrexate information for rheumatoid arthritis. Health Education Research, 20(3): 334–344.
Dickinson, R., Hamrosi, K., Knapp, P., Aslani, P., Sowter, J., Krass, I., & Raynor, D. K
(2013) Suits you? A qualitative study exploring preferences regarding the tailoring of consumer medicines information. International Journal of Pharmacy Practice, 21(4), 207–215.
Dost, D
(2014) Lees voor gebruik de bijsluiter. De invloed van kopjes en structuur op de begrijpelijkheid van de geneesmiddelenbijsluiter. (Bachelor Thesis). Retrieved from [URL]
European Commission
(2009) Guideline on the readability of the labelling and package leaflet of medicinal products for human use. (ENTR/F/2/SF/jr (2009)D/869). Brussels.
European Medicines Agency—EMA
(2013) Quality Review of Documents human product-information annotated template (English) version 9.
Hirsh, D., Clerehan, R., Staples, M., Osborne, R. H., & Buchbinder, R
(2009) Patient assessment of medication information leaflets and validation of the evaluative linguistic framework (ELF). Patient Education and Counseling, 77(2), 248–254.
Isaacson, J.J., Altman Klein, H., & Muldoon, R.V
(1999) Prescription medication information: improving usability through human factors design.
Proceedings of the Human Factors and Ergonomics Society Annual Meeting
, 431, 873–877.
Kiesler, D. J., & Auerbach, S. M
(2006) Optimal matches of patient preferences for information, decision-making and interpersonal behavior: evidence, models and interventions. Patient education and counseling, 61(3), 319–341.
Knapp, P., Berry, D.C., & Raynor, D.K
(2001) Testing two methods of presenting side effect risk information about common medicines. International Journal of Pharmacy Practice, 9 (suppl.), R6.
Knapp, P., Raynor, D. K., & Berry, D. C
(2004) Comparison of two methods of presenting risk information to patients about the side effects of medicines. Quality and Safety in Health Care, 13(3), 176–180.
Lentz, L.R. & Pander Maat, H.L.W
(1994) Patient information leaflets: a functional content analysis and an evaluation study. In P. van den Hoven, E. Woudstra & L. van Waes (Eds.), Functional Communication Quality (pp. 137–148). Amsterdam, Rodopi.
Meijer, A., Grimmelikhuijsen, S., Nell, M.L., & Lentz, L
(2014) Organizational arrangements for targeted transparency. Legal or communicative enactment of disclosure requirements. Information Polity, 19(1–2), 115–127.
Morrow, D.G., Leirer, V.O., Andrassy, J.M., Tanke, E.D., & Stine-Morrow, E.A.L
(1996) Medication instruction design: Younger and older adult schemas for taking medication. Human Factors, 38(4), 556–573.
Morrow, D.G., Leirer, V.O., Andrassy, J.M., Hier, C.M., & Menard, W.E
(1998) The influence of list format and category headers on age differences in understanding medication instructions. Experimental Aging Research, 24(3), 231–256.
Nink, K. & Schröder, H
(2005) Zu Risiken und Nebenwirkungen: Lesen Sie die Packungsbeilage? Bonn: Wissenschaftliches Institut der AOK (WIdO).
Pander Maat, H., & Lentz, L
(2010) Improving the usability of patient information leaflets. Patient Education and Counseling, 801, 113–119.
(2011) Using sorting data to evaluate text structure: an evidence-based proposal for restructuring patient information leaflets. Technical Communication, 58(3), 218–237.
Pander Maat, H., Lentz, L., & Raynor, D.K
(2015) Testing templates for texts: the case of European patient information leaflets for medicines. Manuscript submitted for publication.
Papay, J.I., Fritz, D., Cantu, T., Ellis, M., & Debussey, S
(2010) Assessment of a simplified format of written patient prescription drug information. Drug Information Journal, 44(4), 375–391.
Raynor, D.K., & Dickinson, D
(2009) Key principles to guide development of consumer medicine information – Content analysis of information design texts. The Annals of Pharmacotherapy, 43(4), 700–706.
Schommer, J.C., Doucette, W.C., & Worley, M.M
(2001) Processing prescription drug information under different conditions of presentation. Patient Education and Counseling, 431, 49–59.
Sless, D. & Shrensky, R
(2006) Writing about medicines for people. Usability guidelines for consumer medication information. Communication Research Institute. Canberra. Third edition.
Sweller, J
(1994) Cognitive load theory, learning difficulty, and instructional design. Learning and Instruction, 41, 295–312.
Wilson, E.A.H., & Wolf, M.S
(2009) Working memory and the design of health materials: A cognitive factors perspective. Patient Education and Counseling, 74(3), 318–322.
Wolf, A., Fuchs, J., & Schweim, H.J
(2012) QRD Template Texts Intended for Package Inserts. Development from the first QRD template up to the new draft of July 2012. Die Pharmazeutische Industrie, 74(9), 1540–1549.
Wright, P
(1999) Writing and information design of healthcare materials. In: Candlin, C. & Hyland, K. (Eds.). Writing: Texts, Processes and Practices. Longman, London, 85–95.
Cited by
Cited by 4 other publications
Meloncon, Lisa K.
2017. Patient experience design. Communication Design Quarterly 5:2 ► pp. 19 ff. 
Pander Maat, Henk, Leo Lentz, David K. Raynor & Francesco Pappalardo
2015. How to Test Mandatory Text Templates: The European Patient Information Leaflet. PLOS ONE 10:10 ► pp. e0139250 ff.
Carla Galvão Spinillo, Amanda Rutiquewiski Gomes & Larissa Yumi Asami
2017. Blucher Design Proceedings, ► pp. 1997 ff.
Walker, Sue, Manjula Halai, Rachel Warner & Josefina Bravo
This list is based on CrossRef data as of 22 may 2023. Please note that it may not be complete. Sources presented here have been supplied by the respective publishers. Any errors therein should be reported to them.