How are we communicating about clinical trials? An assessment of the content and readability of recruitment resources

Contemporary Clinical Trials

Volumn 38, Issue 2, 2014, Pages 275-283

  Friedman, Daniela B ^a   Kim, Sei Hill ^a   Tanner, Andrea ^a   Bergeron, Caroline D ^a   Foster, Caroline ^b   General, Kevin ^a  

^a UNIVERSITY OF SOUTH CAROLINA   (United States)

^b Department of Teacher Education and Department of Sociology and Anthropology   (United States)

Author keywords

Clinical trials; Education materials; Internet; Print; Reading level; Recruitment

Indexed keywords

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL (TOPIC); CONTENT ANALYSIS; CONTROLLED STUDY; CONVENIENCE SAMPLE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; QUALITY OF LIFE; READING; UNIVERSITY HOSPITAL; CLINICAL TRIAL; COMPREHENSION; INFORMATION LITERACY; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; PATIENT EDUCATION; PATIENT SELECTION; PROCEDURES;

COMMUNICATION; COMPREHENSION; HUMANS; INFORMATION LITERACY; INFORMED CONSENT; PATIENT EDUCATION AS TOPIC; PATIENT SELECTION;

EID: 84902333117     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2014.05.004     Document Type: Article

References (84)

1. Gul R.B., Ali P.A. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs 2010, 19(1-2):227-233. 10.1111/j.1365-2702.2009.03041.x.
2. Hadidi N., Lindquist R., Treat-Jacobson D., Swanson P. Participant withdrawal: challenges and practical solutions for recruitment and retention in clinical trials. Creat Nurs 2013, 19(1):37-41.
3. Tanner A., Kim S.-H., Friedman D.B., Foster C., Bergeron C. Barriers to medical research participation as perceived by clinical trial investigators: Communicating with rural and African American communities. J Health Commun 2014, [in press].
4. Ford J.G., Howerton M.W., Lai G.Y., Gary T.L., Bolen S., Gibbons M.C., Bass E.B. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 2008, 112(2):228-242. 10.1002/cncr.23157.
5. Ford M.E., Siminoff L.A., Pickelsimer E., Mainous A.G., Smith D.W., Diaz V.A., Tilley B.C. Unequal burden of disease, unequal participation in clinical trials: solutions from African American and Latino community members. Health Soc Work 2013, 38(1):29-38.
6. Guadagnolo B.A., Cina K., Helbig P., Molloy K., Reiner M., Cook E.F., Petereit D.G. Medical mistrust and less satisfaction with health care among Native Americans presenting for cancer treatment. J Health Care Poor Underserved 2009, 20(1):210-226. 10.1353/hpu.0.0108.
7. Friedman D.B., Bergeron C.D., Foster C., Tanner A., Kim S.H. What do people really know and think about clinical trials? A comparison of rural and urban communities in the South. J Community Health 2013, 38(4):642-651. 10.1007/s10900-013-9659-z.
8. Guadagnolo B.A., Petereit D.G., Helbig P., Koop D., Kussman P., Fox Dunn E., Patnaik A. Involving American Indians and medically underserved rural populations in cancer clinical trials. Clin Trials 2009, 6(6):610-617. 10.1177/1740774509348526.
9. Kim S.-H., Tanner A., Friedman D.B., Foster C., Bergeron C.D. Barriers to clinical trials participation: A comparison of rural and urban communities in South Carolina. J Community Health 2014, 39(3):562-571.
10. McComas K.A., Yang Z., Gay G.K., Leonard J.P., Dannenberg A.J., Dillon H. Individuals' willingness to talk to their doctors about clinical trial enrollment. J Health Commun 2010, 15(2):189-204. 10.1080/10810730903528058.
11. Owens O.L., Jackson D.D., Thomas T.L., Friedman D.B., Hebert J.R. African-American men's and women's perceptions of clinical trials research: Focusing on prostate cancer among a high risk population in the South. J Health Care Poor Underserved 2013, 24(4):1784-1800.
12. Bergeron C.D., Foster C., Friedman D.B., Tanner A., Kim S.-H. Current state of clinical trials recruitment in rural South Carolina: a comparison of investigators' perceptions and potential participant eligibility. Rural Remote Health 2013, 13(4):2567.
13. Castel P., Negrier S., Boissel J.P. Why don't cancer patients enter clinical trials? A review. Eur J Cancer 2006, 42(12):1744-1748. Plateforme d'Aide à la Recherche Clinique en Cancérologie de la région, & Rhone-Alpes. 10.1016/j.ejca.2005.10.033.
14. Paramasivan S., Huddart R., Hall E., Lewis R., Birtle A., Donovan J.L. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials 2011, 12:78. 10.1186/1745-6215-12-78.
15. Taylor H.E., Bramley D.E. An analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New Zealand. Anaesth Intensive Care 2012, 40(6):995-998.
16. Dickens C., Lambert B.L., Cromwell T., Piano M.R. Nurse overestimation of patients' health literacy. J Health Commun 2013, 18(Suppl. 1):62-69. 10.1080/10810730.2013.825670.
17. Howard T., Jacobson K.L., Kripalani S. Doctor talk: physicians' use of clear verbal communication. J Health Commun 2013, 18(8):991-1001. 10.1080/10810730.2012.757398.
18. Caplan L., Wolfe F., Michaud K., Quinzanos I., Hirsh J.M. Health literacy is strongly associated with functional status among rheumatoid arthritis patients: A cross-sectional study. Arthritis Care Res 2013, 10.1002/acr.22165.
19. Federman A.D., Wolf M.S., Sofianou A., O'Conor R., Martynenko M., Halm E.A., Wisnivesky J.P. Asthma Outcomes Are Poor among Older Adults with Low Health Literacy. J Asthma 2013, 10.3109/02770903.2013.852202.
20. Sentell T., Zhang W., Davis J., Baker K.K., Braun K.L. The influence of community and individual health literacy on self-reported health status. J Gen Intern Med 2013, 10.1007/s11606-013-2638-3.
21. Westlake C., Sethares K., Davidson P. How can health literacy influence outcomes in heart failure patients? Mechanisms and interventions. Curr Heart Fail Rep 2013, 10(3):232-243. 10.1007/s11897-013-0147-7.
22. Willens D.E., Kripalani S., Schildcrout J.S., Cawthon C., Wallston K., Mion L.C., Roumie C.L. Association of brief health literacy screening and blood pressure in primary care. J Health Commun 2013, 18(Suppl. 1):129-142. 10.1080/10810730.2013.825663.
23. Stableford S., Mettger W. Plain language: a strategic response to the health literacy challenge. J Public Health Policy 2007, 28(1):71-93. 10.1057/palgrave.jphp.3200102.
24. Jefford M., Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol 2008, 9(5):485-493. 10.1016/S1470-2045(08)70128-1.
25. Meade C.D., Howser D.M. Consent forms: how to determine and improve their readability. Oncol Nurs Forum 1992, 19(10):1523-1528.
26. Meade C.D., McKinney W.P., Barnas G.P. Educating patients with limited literacy skills: the effectiveness of printed and videotaped materials about colon cancer. Am J Public Health 1994, 84(1):119-121.
27. Paasche-Orlow M.K., Taylor H.A., Brancati F.L. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 2003, 348(8):721-726. 10.1056/NEJMsa021212.
28. Philipson S.J., Doyle M.A., Gabram S.G., Nightingale C., Philipson E.H. Informed consent for research: a study to evaluate readability and processability to effect change. J Invest Med 1995, 43(5):459-467.
29. Raich P.C., Plomer K.D., Coyne C.A. Literacy, comprehension, and informed consent in clinical research. Cancer Invest 2001, 19(4):437-445.
30. Fagerlin A., Royner D., Stableford S., Jentoft C., Wei J.T., Holmes-Rovner M. Patient Education Materials about the Treatment of Early-Stage Prostate Cancer: A Critical Review. Ann Intern Med 2004, 140:721-728.
31. Doab A., Topp L., Day C.A., Dore G.J., Maher L. Clinical trial literacy among injecting drug users in Sydney, Australia: A pilot study. Contemp Clin Trials 2009, 30(5):431-435. 10.1016/j.cct.2009.04.002.
32. Kruse A.Y., Kjaergard L.L., Krogsgaard K., Gluud C., Mortensen E.L., Gottschau A., Bjerg A.M. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. Control Clin Trials 2000, 21(3):223-240.
33. Tait A.R., Voepel-Lewis T., Malviya S., Philipson S.J. Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding. Arch Pediatr Adolesc Med 2005, 159(4):347-352.
34. Winslow E.H. Patient education materials: Can patients read them, or are they ending up in the trash?. Am J Nurs 2001, 101(10):33-38.
35. Harmon B.E., Blake C.E., Thrasher J.F., Hebert J.R. An evaluation of diet and physical activity messaging in African American churches. Health Educ Behav 2013, 10.1177/1090198113507449.
36. Friedman D.B., Laditka J.N., Laditka S.B., Mathews A.E. Cognitive health messages in popular women's and men's magazines, 2006-2007. Prev Chronic Dis 2010, 7(2):A32.
37. Lindley L.L., Friedman D.B., Struble C. Becoming visible: assessing the availability of online sexual health information for lesbians. Health Promot Pract 2012, 13(4):472-480. 10.1177/1524839910390314.
38. Rose I.D., Friedman D.B., Marquez D.X., Fernandez K. What are older Latinos told about physical activity and cognition? A content analysis of a top-circulating magazine. J Aging Health 2013, 25(7):1143-1158. 10.1177/0898264313494803.
39. Tanner A., Friedman D.B., Koskan A., Barr D. Disaster communication on the internet: a focus on mobilizing information. J Health Commun 2009, 14(8):741-755. 10.1080/10810730903295542.
40. Vandenberg A.E., Price A.E., Friedman D.B., Marchman G., Anderson L.A. How do top cable news websites portray cognition as an aging issue?. Gerontologist 2012, 52(3):367-382. 10.1093/geront/gnr100.
41. Friedman D.B., Foster C., Bergeron C.D., Tanner A., Kim S.-H. A qualitative study of recruitment barriers, motivators, and community-based strategies for increasing clinical trials participation among rural and urban populations. Am J Health Promot 2014 Mar 26, [Epub].
42. Vanderknyff J., Friedman D.B., Tanner A. Framing life and death on YouTube: The strategic communication of organ donation messages by organ procurement organizations. J Health Commun 2014, [in press].
43. Friedman D.B., Hoffman-Goetz L. A systematic review of readability and comprehension instruments used for print and web-based cancer information. Health Educ Behav 2006, 33(3):352-373. 10.1177/1090198105277329.
44. Friedman D.B., Tanner A. Reading difficulty level of medical resources on television Web sites: Recommendations for a social practices approach to consumer health literacy. J Consum Health Internet 2007, 11(4):43-60.
45. Luk A., Aslani P. Tools used to evaluate written medicine and health information: document and user perspectives. Health Educ Behav 2011, 38(4):389-403. 10.1177/1090198110379576.
46. McLaughlin G.H. SMOG grading - a new readability formula. J Read 1969, 12:639-646.
47. Tanner A., Friedman D.B. Authorship and information sourcing for health news on local TV news Web sites: An exploratory analysis. Sci Commun 2011, 33(1):3-27.
48. Houts P.S., Doak C.C., Doak L.G., Loscalzo M.J. The role of pictures in improving health communication: a review of research on attention, comprehension, recall, and adherence. Patient Educ Couns 2006, 61(2):173-190. 10.1016/j.pec.2005.05.004.
49. Kreuter M.W., Lukwago S.N., Bucholtz D.C., Clark E.M., Sanders-Thompson V. Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav 2003, 30(2):133-146.
50. Steele M., Dow L., Baxter G. Promoting public awareness of the links between lifestyle and cancer: A controlled study of the usability of health information leaflets. Int J Med Inform 2011, 80(12):e214-e229.
51. Entman R.M. Framing: Toward clarification of a fractured paradigm. J Commun 1993, 43(4):51-58.
52. O'Keefe D.J., Jensen J.D. The relative persuasiveness of gain-framed and loss-framed messages for encouraging disease detection behaviors: A meta-analytic review. J Commun 2009, 59(2):296-316.
53. Rothman A.J., Salovey P. Shaping perceptions to motivate healthy behavior: the role of message framing. Psychol Bull 1997, 121(1):3-19.
54. Bower P., King M., Nazareth I., Lampe F., Sibbald B. Patient preferences in randomised controlled trials: conceptual framework and implications for research. Soc Sci Med 2005, 61(3):685-695.
55. Edwards S.J., Lilford R.J., Thornton J., Hewison J. Informed consent for clinical trials: in search of the "best" method. Soc Sci Med 1998, 47(11):1825-1840.
56. Llewellyn-Thomas H.A., McGreal M.J., Thiel E.C. Cancer patients' decision making and trial-entry preferences: the effects of" framing" information about short-term toxicity and long-term survival. Med Decis Making 1995, 15(1):4-12.
57. Badarudeen S., Sabharwal S. Assessing readability of patient education materials: current role in orthopaedics. Clin Orthop Relat Res 2010, 468(10):2572-2580.
58. Friedman D.B., Hoffman-Goetz L., Arocha J.F. Health literacy and the World Wide Web: comparing the readability of leading incident cancers on the Internet. Med Inform Internet Med 2006, 31(1):67-87. 10.1080/14639230600628427.
59. Friedman D.B., Laditka S.B., Laditka J.N., Price A.E. A content analysis of cognitive health promotion in popular magazines. Int J Aging Hum Dev 2011, 73(3):253-281.
60. Landis J.R., Koch G.G. The measurement of observer agreement for categorical data. Biometrics 1977, 33:159-174.
61. Rounder D., Slater M., Domenech-Rodriguez M. Adolescent evaluation of gender role and sexual imagery in television advertisements. J Broadcast Electron Media 2003, 47:435-454.
62. Szklo M., Nieto F.J. Epidemiology: Beyond the basics 2004, Jones and Bartlett, Boston, MA.
63. Friedman D.B., Hoffman-Goetz L., Arocha J.F. Readability of cancer information on the internet. J Cancer Educ 2004, 19(2):117-122. 10.1207/s15430154jce1902_13.
64. Friedman D.B., Kao E.K. A comprehensive assessment of the difficulty level and cultural sensitivity of online cancer prevention resources for older minority men. Prev Chronic Dis 2008, 5(1):A07.
65. Friedman D.B., Tanwar M., Richter J.V. Evaluation of online disaster and emergency preparedness resources. Prehosp Disaster Med 2008, 23(5):438-446.
66. Pandiya A. Readability and comprehensibility of informed consent forms for clinical trials. Perspect Clin Res 2010, 1(3):98-100.
67. Friedman D.B., Hoffman-Goetz L. Assessment of cultural sensitivity of cancer information in ethnic print media. J Health Commun 2006, 11(4):425-447. 10.1080/10810730600671920.
68. Hoffman-Goetz L., Friedman D.B. A systematic review of culturally sensitive cancer prevention resources for ethnic minorities. Ethn Dis 2006, 16(4):971-977.
69. Kreuter M.W., Wray R.J. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav 2003, 27(Suppl. 3):S227-S232.
70. Resnicow K., Baranowski T., Ahluwalia J.S., Braithwaite R.L. Cultural sensitivity in public health: defined and demystified. Ethn Dis 1999, 9(1):10-21.
71. Branson R.D., Davis K., Butler K.L. African Americans' participation in clinical research: importance, barriers, and solutions. Am J Surg 2007, 193(1):32-39. [discussion 40]. 10.1016/j.amjsurg.2005.11.007.
72. Gross C.P., Filardo G., Mayne S.T., Krumholz H.M. The impact of socioeconomic status and race on trial participation for older women with breast cancer. Cancer 2005, 103(3):483-491. 10.1002/cncr.20792.
73. Heiney S.P., Arp Adams S., Drake B.F., Bryant L.H., Bridges L., Hebert J.R. Successful subject recruitment for a prostate cancer behavioral intervention trial. Clin Trials (Lond Engl) 2010, 7(4):411-417. 10.1177/1740774510373491.
74. Rivers D., August E.M., Sehovic I., Lee Green B., Quinn G.P. A systematic review of the factors influencing African Americans' participation in cancer clinical trials. Contemp Clin Trials 2013, 35(2):13-32. 10.1016/j.cct.2013.03.007.
75. Waters L.A., Galichet B., Owen N., Eakin E. Who participates in physical activity intervention trials?. J Phys Act Health 2011, 8(1):85-103.
76. Andriole G.L., Crawford E.D., Grubb R.L., Buys S.S., Chia D., Church T.R., Team P.P. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009, 360(13):1310-1319. 10.1056/NEJMoa0810696.
77. Tanner A., Friedman D.B. Health on the Web: An examination of health content and mobilizing information on local TV Web sites. Inform Health Soc Care 2011, 36(1):50-61.
78. Gargoum F.S., O'Keeffe S.T. Readability and content of patient information leaflets for endoscopic procedures. Ir J Med Sci 2013, 10.1007/s11845-013-1033-8.
79. Wilson F.L., Williams B.N. Assessing the readability of skin care and pressure ulcer patient education materials. J Wound Ostomy Continence Nurs 2003, 30(4):224-230. 10.1067/mjw.2003.137.
80. Doak C., Doak L., Root J. Teaching patients with low literacy skills 1996, Lippincott, Philadelphia, PA.
81. Dominick G.M., Friedman D.B., Saunders R.P., Hussey J., Watkins K.K. Factors associated with physical activity literacy among foster parents. Am J Health Behav 2012, 36(2):179-192.
82. Friedman D.B., Hoffman-Goetz L. An exploratory study of older adults' comprehension of printed cancer information: is readability a key factor?. J Health Commun 2007, 12(5):423-437. 10.1080/10810730701438658.
83. Hall A.E., Sanson-Fisher R.W., Lynagh M.C., Threlfall T., D'Este C.A. Format and readability of an enhanced invitation letter did not affect participation rates in a cancer registry-based study: a randomized controlled trial. J Clin Epidemiol 2013, 66(1):85-94. 10.1016/j.jclinepi.2012.07.016.
84. Tamariz L., Palacio A., Robert M., Marcus E.N. Improving the informed consent process for research subjects with low literacy: a systematic review. J Gen Intern Med 2013, 28(1):121-126. 10.1007/s11606-012-2133-2.