Article thumbnail

Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

By Peter Knapp, David K Raynor, Jonathan Silcock and Brian Parkinson
Topics: Research Article
Publisher: BioMed Central
OAI identifier:
Provided by: PubMed Central

To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.

Suggested articles


  1. (1948). A new readability yardstick.
  2. (2004). Assessing patient comprehension of informed consent forms. Control Clin Trials
  3. (2008). C: Recall of informed consent information by healthy volunteers in clinical trials.
  4. (1975). Chissom BS: Derivation of new readability formulas (Automated Readability Index, Fog Count and Knapp et al.
  5. (2006). Communication and informed consent in phase 1 trials: a review of the literature. Support Care Cancer
  6. (2009). Draft Guideline on the readability of the label and package leaflet of medicinal products for human use. Revision
  7. (2010). Examining the readability of patient-informed consent forms.
  8. (2006). Expert Scientific Group on Phase One Clinical Trials: Final Report London: Her Majesty’s Stationery Office;
  9. (2011). Fallowfield L: What oncologists believe they said and what patients believe they heard: an analysis of Phase 1 trial discussions.
  10. (2003). FL: Readability standards for informed-consent forms as compared with actual readability.
  11. (2006). HE: Long term clinical trials: how much information do participants retain from the informed consent process? Contemp Clin Trials
  12. (1999). How do doctors explain randomised clinical trials to their patients?
  13. (1998). Hubal RC: Getting meaningful informed consent from older adults: a structured literature review of empirical research.
  14. (2008). Improvement of informed consent and the quality of consent documents. Lancet Oncol
  15. (1991). Informed consent: study of quality of information given to participants in a clinical trial. Br Med J
  16. (1998). JL: Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial. BMJ
  17. (2009). Key principles to guide development of consumer medicines information - content analysis of information design texts. Ann Pharmacother
  18. (2009). Performance-based readability testing of participant materials for a Phase 1 trial: TGN1412. J Med Ethics
  19. (2009). Performance-based readability testing of participant materials for a Phase 3 IVF trial. Trials
  20. (2007). Research Ethics Service: Information sheets and consent forms: guidance for researchers and reviewers
  21. Six taken ill after drug trials. [
  22. (1969). SMOG Grading - a new readability formula.
  23. (2007). Society: Report of the Working Party on Statistical Issues in First-in-Man studies London: Royal Statistical Society;
  24. (2007). The Association of the British Pharmaceutical Industry: Guidelines for Phase 1 Clinical Trials
  25. (2011). The NHS Operating Framework for England 2010/11. [http://www. operatingframework2010-2011.pdf], (accessed 17
  26. (2009). User testing of a participant information sheet for a Phase 3 trial of cholesterol-lowering therapy [abstract].