Medical Writing Writing for Lay Audiences Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations
mew-150pxjpg

Volume 24, Issue 4 - Writing for Lay Audiences

Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations

Abstract

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced significant challenges for medical writers, who are now tasked with translating and explaining complex concepts for the lay audience. This article explains some of the challenges faced by medical writers in this new era.

Download the full article

References

  1. Liberating the NHS: No decision about me without me. 2012 December [cited 2015 July 24]. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216980/Liberating-the-NHS-No-decision-about-me-without-me-Government-response.pdf
  2. Health Online 2013. 2013 January 15 [cited 2015 July 24]. Available from: http://www.pewinternet.org/2013/01/15/health-online-2013
  3. Chamberlain James L, Creuwels LAJM, Davies M. Risk management plans–New challenges for a new era. Reg Rapp 2014;11(6):4–7.
  4. Prechtel K, Rechtsteiner S. Medical writing for two audiences–The RMP public summary. Med Writing 2015;24(4):xx–xx.
  5. Presentation from Dr Juan Garcia Burgos, DIA 2015.
  6. Williams J. The Skills for Life survey: A national needs and impact survey of literacy, numeracy and ICT skills. No. 490. The Stationery Office; 2003.
  7. Gallow CL. Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance. Med Writing 2015;24(4):xx–xx.
  8. Sroka-Saidi K, Boggetti B, Schindler TM. Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results. EMWA. 2015;24(1):24–27.
  9. Reya VF, Nelson WL, Han PK, Pignone MP. Decision making and cancer. Am Psychol 2015;70(2):105–118.
  10. Wilson DK, Purdon SE, Wallston KA. Compliance to health recommendations: A theoretical overview of message framing. Health Ed Res 1988;3:161–171.
  11. McNeil BJ, Pauker SG, Sox HC, Tversky A. On the elicidation of preferences for alternative therapies. NEJM 1982;306:1259–1262.
  12. Edwards A, Elwyn G, Covey J, Matthews E, Pill R. Presenting Risk Information—A Review of the Effects of ‘‘Framing’’ and other Manipulations on Patient Outcomes. J Health Comm 2001;6:61–82.
  13. Covey J. A meta-analysis of the effects of presenting treatment benefits in different formats. Medical Decision Making 2007;27:638–54.
  14. Fraenkel L, Peters E, Charpentier P, Olsen B, Errante L, Schoen RT, et al.. Decision tool to improve the quality of care in rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64(7):977–85.
  15. Camerer C, Weber M. Recent developments in modeling preferences: Uncertainty and ambiguity. J Risk and Uncertainty 1992;5(4):325–370.
  16. Han PKJ, Klein WMP, Arora NK. Varieties of uncertainty in health care: a conceptual taxonomy. Med Decis Making. 2011;31(6):828–838.
  17. Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. Helping doctors and patients make sense of health statistics. Psychol Sci Public Interest 2007;8:53–96.
  18. Akl EA, Oxman AD, Herrin J, Vist GE, Terrenato I, Sperati F, et al.. Using alternative statistical formats for presenting risks and risk reductions. Cochrane Database of Systematic Reviews 2011, Issue 3. Art. No.: CD006776.
  19. Hoffrage U, Lindsey S, Hertwig R, Gigerenzer G. Medicine. Communicating statistical information. Science 2000;290(5500):2261–2.
  20. Zikmund-Fisher BJ. The Right Tool Is What They Need, Not What We Have. A Taxonomy of Appropriate Levels of Precision in Patient Risk Communication. Med Care Res Rev 2013;70(1):37S–49S.

Search

Articles

Writing for lay audiences
President's Message
Writing for lay audiences: A challenge for scientists
Patient education accessibility
Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations
Medical writing for two audiences – The RMP public summary
Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance
Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?
What do writers need to know about user testing?
Medical journalism: Another way to write about science
Elements of storytelling in medical journalism
A stroll through the medical blogosphere
Writing narrative style literature reviews
News from the EMA
Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations
The Webscout
In the Bookstores
Regulatory Writing
Lingua Franca and Beyond
Gained in Translation
English Grammar and Style
Out On Our Own

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief:

Co-Editor:

Editorial Manager

  • Victoria White (Tampa, Florida, USA)
show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: