Medical Writing Medical Education Patient education in clinical trials and throughout the product lifecycle

Volume 25, Issue 4 - Medical Education

Patient education in clinical trials and throughout the product lifecycle

Abstract

Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold. Patient education can be confusing given the wealth of new technologies in healthcare communications, combined with patients being more involved in decisions about their health, and different national and international guidelines and legislations to be adhered to. Furthermore, writers face complexities of trying to meet the needs of diverse populations of patients and specific individuals. In this article, we discuss the importance of effective patient education activities for specific phases of the product lifecycle (from clinical trial participation through to prescribed medicines) and of the patient journey (from disease awareness and diagnosis through to living with long-term chronic illness). The considerations and constraints of developing educational content for patients, and practical guidance for writing such materials are discussed.

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References

  1. Macquart de Terline D, Hejblum G, Fernandez C, Cohen A, Antignac M. PLoS One. 2016;11(1):e0146927.
  2. Feudtner C. What are the goals of patient education? West J Med. 2001;174:173-4.
  3. Adams RJ. Improving health outcomes with better patient understanding and education. Risk Manag Health Policy. 2010;3:61-72.
  4. Hoving C, Visser A, Mullen PD, van den Borne B. A history of patient education by health professionals in Europe and North America: from authority to shared decision making education. Patient Educ Couns. 2010;78(3):275-81.
  5. Powell J, Inglis N, Ronnie J, Large S. The characteristics and motivations of online health information seekers: cross-sectional survey and qualitative interview study. J Med Internet Res. 2011;13(1):e20.
  6. Anderson CM. Information therapy: a prescription for the digital era. Health Care Manag (Frederick). 2013;32(3):242-5.
  7. Hawkins RP, Kreuter M, Resnicow K, Fishbein M, Dijkstra A. Understanding tailoring in communicating about health. Health Educ Res. 2008;23(3):454-66.
  8. Salita JT. Writing for lay audiences: a challenge for scientists. Medical Writing. 2015;24(4):183-9.
  9. Gul R B, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19 (1-2):227-33.
  10. Kaur G, Smyth RL, Williamson P. Developing a survey of barriers and facilitators to recruitment in randomized controlled trials. Trials. 2012;13:218.
  11. Brandberg Y, Johansson H, Bergenmar M. Patients’ knowledge and perceived understanding – associations with consenting to participated in cancer clinical trials. Contemp Clin Trials Comm. 2016;2:6-11.
  12. The Center for Information and Study on Clinical Research Participation (CISCRP). Perceptions and Insights Study: Report on ineligible participants and those who terminate participation early. 2013. Available from: https://www.ciscrp.org/download/2013-perceptions-insights-study-ineligibleparticipants-and-those-who-drop-out/?wpdmdl=6650
  13. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 Good Clinical Practice: Consolidated guidance. 1996. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073122.pdf
  14. The World Medical Association. Declaration of Helsinki. 2013 [cited 1 Oct 2016]. Available from: http://www.wma.net/en/30publications/10policies/b3/
  15. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. 2002. Available from: http://www.recerca.uab.es/ceeah/docs/cioms.pdf
  16. Council for International Organizations of Medical Sciences (CIOMS). Final draft CIOMS guidelines. Version 10. September 2015. Available from: http://www.cioms.ch/final_draft_CIOMS_guidelines-10_september_2015-with_watermarks.pdf
  17. Cartmell KB, Bonilha HS, Matson T, Bryant DC, Zapka J, Bentz TA, et al. Patient participation in cancer clinical trials: a pilot test of lay navigation. Contemp Clin Trials Comm. 2016;3:86-93.
  18. Siegal G, Bonnie RJ, Appelbaum PS. Personalized disclosure by information-ondemand: attending to patients’ needs in the informed consent process. J Law Med Ethics. 2012;40(2):359-67.
  19. US Food and Drug Administration (FDA). Use of electronic informed consent in clinical investigations. Draft guidance. March 2015. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm436811.pdf
  20. European Parliament. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm436811.pdfhttp://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
  21. Gillow CL. Layperson summaries of clinical trial results: useful resources in the vacuum of regulatory guidance. Medical Writing. 2015;24(4):205-9.
  22. Robben S, van Kempen J, Heinen M, Zuidema S, Olde RIkkert M, Schers H, et al. Preferences for receiving information among frail older adults and their informal caregivers: a qualitative study. Fam Pract. 2012;29(6):742-7.
  23. Hirsch O, Keller H, Krones T, Donner- Banzhoff N. arriba-lib: evaluation of an electronic library of decision aids in primary care physicians. BMC Med Inform Decis Mak. 2012 Jun 6;12:48.
  24. European Patients’ Forum. Patient Empowerment Campaign. 2015 [cited 1 Oct 2016]. Available from: www.eupatient.eu/campaign/PatientsprescribE
  25. European Patients’ Forum. Improving the sustainability of healthcare systems through better adherence to therapies: a multistakeholder approach. Background briefing. 2011 [cited 1 Oct 2016]. Available from: http://www.eu-patient.eu/globalassets/policy/adherence-compliance-concordance/adherence–joint-briefing-paper.pdf
  26. Miller TA. Health literacy and adherence to medical treatment in chronic and acute illness: a meta-analysis. Patient Educ Couns. 2016;99(7):1079-86.
  27. Matsumaya RK, Kuhn LA, Molisani A, Wilson-Genderson MC. Cancer patients’ information needs the first nine months after diagnosis. Patient Educ Couns. 2013;90(1):96-102.
  28. Prochaska JO, DiClemente CC. Stages and processes of self-change in smoking: toward an integrative model of change. J Consult Clin Psychol. 1983;51(3):390–5.
  29. Prochaska JO. Assessing how people change. Cancer. 1991;67(3 Suppl):805-7.
  30. Medicines and Healthcare Products Regulatory Agency (MHRA). Disease Awareness Campaign Guidelines: Appendix 7. 2012 Jul. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/407290/Appendix_7_-_Blue_Guide.pdf
  31. The Association of the British Pharmaceutical Industry (ABPI). Guidance notes for patient safety and pharmacovigilance in patient support programmes. 2011 [cited 1 Oct 2016]. Available from: http://www.abpi.org.uk/our-work/library/guidelines/Pages/patient-safety-pharmacovigilance-.aspx
  32. U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. Simply put – a guide for creating easy to understand materials. 2010. Available from: http://www.cdc.gov/healthliteracy/pdf/Simply_Put.pdf
  33. Dale E. Audiovisual Methods in Teaching. 3rd ed. New York: Holt, Rinehart & Winston; 1969:108.
  34. Giuse NB, Koonce TY, Storrow AB, Kusnoor SV, Ye F. Using health literacy and learning style preferences to optimise the delivery of health information. J Health Commun. 2012;17(Suppl 3): 122-40.
  35. Walsh E, Sheridan A. Factors affecting patient participation in clinical trials in Ireland: a narrative review. Contemp Clin Trials Comm. 2016;3:23-31.
  36. US Food and Drug Administration (FDA). Recruiting Study Subjects – Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators. 2016 [cited 1 Oct 2016]. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm
  37. World Self-Medication Industry (WSMI). Advertising of non-prescription medicines to the public. 2008. Available from: http://www.wsmi.org/wp-content/data/pdf/wsmi_brochureadvertising.pdf

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Articles

Medical Education
President's Message
EMWA News
Writing for mixed-media training programmes
Lessons from building an accredited medical conference: Design and delivery
Medical education in a medcomms agency
Patient education in clinical trials and throughout the product lifecycle
Writing, publishing, and disseminating a medical review
CME in the Deutsches Ärzteblatt and the development of multiple choice questions for medical educational purposes
Covering a medical advisory board meeting and creating the report or publication: The role of the professional medical writer
Peer review fraud
News from the EMA
Journal Watch
In The Bookstores
The Webscout
Good Writing Practice
Medical Communications
Getting Your Foot in the Door
Profile: An Interview with the organisers of the first Internship Forum
Out on Our Own

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