We investigated the readability of informed consent documents linguistically and compared old and new ICDs. Twenty ICDs (ten from 1987–1992 and ten from 2006–2007) were included. The Evaluative Linguistic Framework (ELF) was used to analyze the texts. The ELF evaluates the following items: Main themes, order of themes, rhetorical functions, the relationship between reader and writer, meta-discourse, headings, expert terminology, and visual aspects. An ICD is considered readable if it achieves the goal of inviting the reader to participate and explaining the implication of participation. The new ICDs were more readable than the old ones, as they were more oriented towards research, contained instructions about how to consent, and provided clear contact information. Aspects that reduced the readability of the new ICDs were the large number of topics, details, and actors presented. The readability of the old ICDs was enhanced by fewer topics, a clear presentation of the involved actors, and brevity. However, their readability was reduced by the inclusion of a vast amount of information about the reader's diagnosis and treatment.
BakerM. T. & TaubH. A. (1983). Readability of informed consent forms for research in a Veterans Administration medical center. Journal of the American Medical Association, 250(19), 2646–2648.
2.
BergerO.GrønbergB. H.SandK.KaasaS., & LogeJ. H. (2009). The length of consent documents in oncological trials is doubled in twenty years. Annals of Oncology, 20(2), 379–385.
3.
ClerehanR. & BuchbinderR. (2006). Toward a more valid account of functional text quality: The case of the patient information leaflet. Text & Talk, 26(1), 39–68.
4.
ClerehanR.BuchbinderR., & MoodieJ. (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.
5.
ClerehanR.HirshD., & BuchbinderR. (2009). Medication information leaflets for patients: The further validation of an analytic linguistic framework. Communication and Medicine, 6(2), 117–127.
6.
CriscioneL. G.SugarmanJ.SandersL.PisetskyD. S., & St. ClairE. W. (2003). Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis and Rheumatism, 49(3), 361–367.
7.
ErlenJ. A. (2010). Informed consent: Revisiting the issues. Orthopaedic Nursing, 29(4), 276–280.
8.
FinnieR. K.FelderT. M.LinderS. K., & MullenP. D. (2010). Beyond reading level: A systematic review of the suitability of cancer education print and Web-based materials. Journal of Cancer Education, 25(4), 497–505.
9.
FleschR. (1948). A new readability yardstick. Journal of Applied Psychology, 32(3), 221–223.
10.
FryE. (1968). A readability formula that saves time. Journal of Reading, 11(7), 513–516, 575–578.
11.
GoldsteinA. O.FrasierP.CurtisP.ReidA., & KreherN. E. (1996). Consent form readability in university-sponsored research. Journal of Family Practice, 42(6), 606–611.
12.
GrossmanS. A.PiantadosiS., & CovaheyC. (1994). Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?Journal of Clinical Oncology, 12(10), 2211–2215.
13.
GunningR. (1952). The technique of clear writing. New York: McGraw-Hill.
14.
HirshD.ClerehanR.StaplesM.OsborneR. H., & BuchbinderR. (2009). Patient assessment of medication information leaflets and validation of the Evaluative Linguistic Framework (ELF). Patient Education and Counseling, 77(2), 248–254.
15.
JeffordM. & MooreR. (2008). Improvement of informed consent and the quality of consent documents. Lancet Oncology, 9(5), 485–493.
16.
JoffeS.CookE. F.ClearyP. D.ClarkJ. W., & WeeksJ. C. (2001). Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet, 358(9295), 1772–1777.
17.
KnappP.RaynorD. K.SilcockJ., & ParkinsonB. (2011). Can user testing of a clinical trial patient information sheet make it fit-for-purpose? A randomized controlled trial. BMC Medicine, 9, 89.
18.
LoverdeM. E.ProchazkaA. V., & ByynyR. L. (1989). Research consent forms: Continued unreadability and increasing length. Journal of General Internal Medicine, 4(5), 410–412.
19.
LynoeN.SandlundM.DahlqvistG., & JacobssonL. (1991). Informed consent: Study of quality of information given to participants in a clinical trial. British Medical Journal, 303(6803), 610–613.
20.
MeadeC. D. & HowserD. M. (1992). Consent forms: How to determine and improve their readability. Oncology Nursing Forum, 19(10), 1523–1528.
21.
MeadeC. D. & SmithC. F. (1991). Readability formulas: Cautions and critera. Patient Education and Counseling, 17(2), 153–158.
22.
MurphyJ.GambleG., & SharpeN. (1994). Readability of subject information leaflets for medical research. New Zealand Medical Journal, 107(991), 509–510.
23.
NystrandM. (1986). The structure of written communication: Studies in reciprocity between writers and readers. Orlando: Academic.
24.
OgloffJ. R. & OttoR. K. (1991). Are research participants truly informed? Readability of informed consent forms used in research. Ethics and Behavior, 1(4), 239–252.
25.
PetersonB. T.ClancyS. J.ChampionK., & McLartyJ. W. (1992). Improving readability of consent forms: What the computers may not tell you. IRB, 14(6), 6–8.
26.
PhilipsonS. J.DoyleM. A.GabramS. G.NightingaleC., & PhilipsonE. H. (1995). Informed consent for research: A study to evaluate readability and processability to effect change. Journal of Investigative Medicine, 43(5), 459–467.
27.
PichertJ. & ElamP. (1985). Readability formulas may mislead you. Patient Education and Counseling, 7(2), 181–191.
28.
RiveraR.ReedJ. S., & MeniusD. (1992). Evaluating the readability of informed consent forms used in contraceptive clinical trials. International Journal of Gynaecology and Obstetrics, 38(3), 227–230.
29.
SandK.BergerO.LogeJ.GrønbergB., & KaasaS. (2008). Lung cancer patients' perceptions of informed consent documents. Patient Education and Counseling, 73(2), 313–317.
30.
SchriverK. A. (1997). Dynamics in document design. New York: Wiley Computer.
31.
SchultzA. L.PardeeG., & EnsinckJ. W. (1975). Are research subjects really informed?Western Journal of Medicine, 123(1), 76–80.
32.
SharpS. M. (2004). Consent documents for oncology trials: Does anybody read these things?American Journal of Clinical Oncology, 27(6), 570–575.
33.
TarnowskiK. J.AllenD. M.MayhallC., & KellyP. A. (1990). Readability of pediatric biomedical research informed consent forms. Pediatrics, 85(1), 58–62.
