Patient information leaflets (PILs) for UK randomised controlled trials: A feasibility study exploring whether they contain information to support decision making about trial participation

Trials

Volumn 15, Issue 1, 2014, Pages

  Gillies, Katie ^a   Huang, Wan ^a   Skea, Zoë ^a   Brehaut, Jamie ^b   Cotton, Seonaidh ^a  

^a UNIVERSITY OF ABERDEEN   (United Kingdom)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

Author keywords

Decision support; Informed consent; Patient information leaflets; Randomised controlled trials

Indexed keywords

ADULT; ARTICLE; CONTROLLED STUDY; DECISION MAKING; DECISION SUPPORT SYSTEM; FEASIBILITY STUDY; FEMALE; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MAJOR CLINICAL STUDY; MALE; MEDICAL INFORMATION; PATIENT INFORMATION; PATIENT INFORMATION LEAFLETS; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; UNITED KINGDOM;

ACCESS TO INFORMATION; CHOICE BEHAVIOR; COMPREHENSION; FEASIBILITY STUDIES; GREAT BRITAIN; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HEALTH INFORMATION SYSTEMS; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HEALTH LITERACY; HUMANS; INFORMED CONSENT; PAMPHLETS; PATIENT EDUCATION AS TOPIC; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH SUBJECTS; WRITING;

EID: 84896726814     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-62     Document Type: Article

References (39)

1. World Medical Association (WMA) WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects 2008, Ferney-Voltaire: WMA, http://www.wma.net/en/30publications/10policies/b3/index.html, World Medical Association (WMA).
2. Beauchamp TL, Childress JF. Principles of Biomedical Ethics 1994, Oxford: Oxford University Press.
3. International Conference on Harmonisation (ICH) ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1) 1996, Geneva: ICH, Step 4 version, International Conference on Harmonisation (ICH).
4. National Research Ethics Service (NRES) Information Sheet and Consent Forms: Guidance for Researchers and Reviewers 2009, London: National Health Service, National Patient Safety Agency, National Research Ethics Service (NRES).
5. Wade J, Donovan JL, Lane JA, Neal DE, Hamdy FC. It's not just what you say, it's also how you say it: opening the 'black box' of informed consent appointments in randomised controlled trials. Soc Sci Med 2009, 68:2018-2028. 10.1016/j.socscimed.2009.02.023, 19364625.
6. Antoniou EE, Draper H, Reed K, Buris A, Southwood TR, Zeegers MP. An empirical study on the preferred size of the participant information sheet in research. J Med Ethics 2011, 37:557-562. 10.1136/jme.2010.041871, 21478421.
7. Brown RF, Shuk E, Butow P, Edgerson S, Tattersall MH, Ostroff JS. Identifying patient information needs about cancer clinical trials using a Question Prompt List. Patient Educ Couns 2011, 84:69-77. 10.1016/j.pec.2010.07.005, 2978253, 20675095.
8. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 2000, 6(292):1593-1601.
9. Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, Cothart IR, Ross S, Shepherd SM, Russell D. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess 1999, 3:1-143.
10. Sand K, Loge JH, Berger O, Gronberg BH, Kaasa S. Lung cancer patients' perceptions of informed consent documents. Patient Educ Couns 2008, 73:313-317. 10.1016/j.pec.2008.06.011, 18691845.
11. Canvin K, Jacoby A. Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial. Trials 2006, 7:32. 10.1186/1745-6215-7-32, 1770934, 17163988.
12. Estey A, Musseau A, Keehn L. Patient's understanding of health information: a multihospital comparison. Patient Educ Couns 1994, 24:73-78. 10.1016/0738-3991(94)90027-2, 7862597.
13. Griffin JM, Struve JK, Collins D, Liu D, Nelson DB, Bloomfield HE. Long term clinical trials: how much information do participants retain from the informed consent process?. Contemp Clin Trials 2006, 27:441-448. 10.1016/j.cct.2006.04.006, 16798101.
14. Itoh K, Sasaki Y, Fujii H, Ohtsu T, Wakita H, Igarashi T, Abe K. Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations. Br J Cancer 1997, 76:107-113. 10.1038/bjc.1997.344, 2223787, 9218741.
15. Kruse AY, Kjaergard LL, Krogsgaard K, Gluud C, Mortensen EL, Gottschau A, Bjerg AM. A randomised trial assessing the impact of written information on outpatients' knowledge about attitude toward randomised clinical trials. The INFO trial group. Control Clin Trials 2000, 21:223-240. 10.1016/S0197-2456(00)00048-9, 10822120.
16. Murphy DA, O'Keefe ZH, Kaufman AH. Improving comprehension and recall of information for an HIV vaccine trial among women at risk for HIV: reading level simplification and inclusion of pictures to illustrate key concepts. AIDS Educ Prev 1999, 11:389-399.
17. Coyne CA, Xu R, Raich P, Plomer K, Dignan M, Wenzel L, Fairclough D, Habermann T, Schnell L, Quella S, Cella D, Eastern Cooperative Oncology Group Randomised, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 2003, 21:836-842. 10.1200/JCO.2003.07.022, 12610182, Eastern Cooperative Oncology Group.
18. Wray RJ, Stryker JE, Winer E, Demetri G, Emmons KM. Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations. J Cancer Educ 2007, 22:21-24. 10.1007/BF03174370, 17570804.
19. Ives NJ, Troop M, Waters A, Davies S, Higgs S, Esterbrook PJ. Does an HIV clinical trial information booklet improve patient knowledge and understanding of HIV clinical trials?. HIV Med 2001, 2:241-249. 10.1046/j.1464-2662.2001.00084.x, 11737404.
20. Bjorn E, Rossel P, Holm S. Can the written information to research subjects be improved? An empirical study. J Med Ethics 1999, 25:263-267. 10.1136/jme.25.3.263, 479221, 10390684.
21. Guarino P, Lamping DL, Elbourne D, Carpenter J, Peduzzi P. A brief measure of perceived understanding of informed consent in a clinical trial was validated. J Clin Epidemiol 2006, 59:608-614. 10.1016/j.jclinepi.2005.11.009, 16713523.
22. Ryan RE, Prictor MJ, McLuaghlin KJ, Hill SJ. Audio-visual presentation of information for informed consent for participation in clinical trial. Cochrane Database Syt Rev 2008, 23:CD003717.
23. Dunn LB, Lindamer LA, Palmer BW, Schneiderman LJ, Jeste DV. Enhancing comprehension of consent for research in older patients with psychosis: a randomised study of novel consent procedure. Am J Psychiatry 2001, 158:1911-1913. 10.1176/appi.ajp.158.11.1911, 11691700.
24. Knapp P, Raynor DK, Silcock J, Parkinson B. Can user-testing of a clinical trial information sheet make it fit-for-purpose? - a randomised controlled trial. BMC Med 2011, 9:89. 10.1186/1741-7015-9-89, 3152894, 21777435.
25. Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Homes Rovner M, Llewellyn Thomas H, Lyddiatt A, Legare F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2011, 10:CD001431.
26. Abhyankar P. Decision making about cancer treatment and clinical trial participation. PhD thesis 2008, Leeds: University of Leeds.
27. McCann S, Campbell MK, Entwistle VE. Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials 2010, 11:31. 10.1186/1745-6215-11-31, 2848220, 20307273.
28. Juraskova I, Butow P, Lopez A, Secombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF. Improving informed consent: a pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect 2008, 11:252-262. 10.1111/j.1369-7625.2008.00498.x, 18816321.
29. Sundaresan P, Turner S, Kneebone A, Pearse M, Butow P. Evaluating the utility of a patient decision aid for potential participants of a prostate cancer trial (RAVES-ROG 08.03). Radiother Oncol 2011, 101(3):521-524. 10.1016/j.radonc.2011.07.016, 21985948.
30. Abhyankar P, Bekker HL, Summers BA, Velikova G. Why values elicitation techniques enable people to make informed decisions about cancer trial participation. Health Expect 2011, 14:20-32.
31. Brehaut JC, Lott A, Fergusson DA, Shojania KG, Kimmelman J, Saginur R. Can patient decision aids help people make good decisions about participating in clinical trials? A study protocol. Implement Sci 2008, 23:38.
32. Gillies K, Entwistle V. Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision. J Med Ethics 2012, 38(12):751-756. 10.1136/medethics-2011-100059, 22875981.
33. Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barrat A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moujmid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T. International Patient Decision Aid Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ 2006, 333:417. 10.1136/bmj.38926.629329.AE, 1553508, 16908462.
34. Brehaut JC, Carroll K, Elwyn G, Saginur R, Kimmelman J, Shojania K, Syrowatka A, Nguyen T, Hoe E, Fergusson D. Informed consent documents do not encourage good-quality decision making. J Clin Epidemiol 2012, 65:708-724. 10.1016/j.jclinepi.2012.01.004, 22537428.
35. Tait AR, Voepel-Lewis T, Zikmund-Fisher BJ, Fagerlin A. The effect of format on parents' understanding of the risks and benefits of clinical research: a comparison between text, tables and graphics. J Health Commun 2010, 15:487-501. 10.1080/10810730.2010.492560, 2915576, 20677054.
36. The European Parliament and the Council of the European Union Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001. OJEC 2001, 121:34-44. The European Parliament and the Council of the European Union.
37. Flesch-Kincaid readability calculator. http://www.standards-schmandards.com/exhibits/rix/.
38. Boulos MN. British internet-derived patient information on diabetes mellitus: is it readable?. Diabetes Technol Ther 2005, 7(3):528-535. 10.1089/dia.2005.7.528, 15929685.
39. Beardsley E, Jefford M, Mileshkin L. Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening?. J Clin Oncol 2007, 25:e13-e14. 10.1200/JCO.2006.10.3341, 17369564.