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Audio-visual presentation of information for informed consent for participation in clinical trials

  1. Anneliese Synnot1,2,*,
  2. Rebecca Ryan1,2,
  3. Megan Prictor2,
  4. Deirdre Fetherstonhaugh3,
  5. Barbara Parker4

Editorial Group: Cochrane Consumers and Communication Group

Published Online: 9 MAY 2014

Assessed as up-to-date: 13 JUN 2012

DOI: 10.1002/14651858.CD003717.pub3


How to Cite

Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2014, Issue 5. Art. No.: CD003717. DOI: 10.1002/14651858.CD003717.pub3.

Author Information

  1. 1

    La Trobe University, Centre for Health Communication and Participation, School of Public Health and Human Biosciences, Bundoora, Vic, Australia

  2. 2

    School of Public Health and Human Biosciences, La Trobe University, Cochrane Consumers and Communication Review Group, Bundoora, Victoria, Australia

  3. 3

    La Trobe University, Australian Centre for Evidence Based Aged Care (ACEBAC), Bundoora, Victoria, Australia

  4. 4

    La Trobe University, Australian Institute for Primary Care & Ageing, Faculty of Health Sciences, Bundoora, Victoria, Australia

*Anneliese Synnot, Centre for Health Communication and Participation, School of Public Health and Human Biosciences, La Trobe University, Bundoora, Vic, 3086, Australia. a.synnot@latrobe.edu.au.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 9 MAY 2014

SEARCH

References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. Additional references
  5. References to other published versions of this review
Agre 2003a {published and unpublished data}
  • Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB: Ethics and Human Research 2003;25(6):1-7.
Benson 1988 {published and unpublished data}
Campbell 2004 {published and unpublished data}
  • Campbell FA, Goldman BD, Boccia ML, Skinner M. The effect of format modifications and reading comprehension on recall of informed consent information by low-income parents: a comparison of print, video, and computer-based presentations. Patient Education and Counseling 2004;53:205-16.
Harmell 2012 {published and unpublished data}
  • Harmell AL, Palmer BW, Jeste DV. Preliminary study of a web-based tool for enhancing the informed consent process in schizophrenia research. Schizophrenia Research 2012;141:247-50.
Hoffner 2012 {published data only (unpublished sought but not used)}
  • Hitchcock-Bryan S, Hoffner B, Joffe S, Powell M, Parker C, Wolanski A, et al. Entering a Clinical Trial: Is It Right For You?- A randomized study of the clinical trials video and its impact on the informed consent process [Abstract No. 9072]. Journal of Clinical Oncology : ASCO annual meeting proceedings. 2007; Vol. 18S Part I:510.
  • Hoffner B, Bauer-Wu S, Hitchcock-Bryan S, Powell M, Wolanski A, Joffe S. "Entering a Clinical Trial: Is it Right For You?" A randomized study of the clinical trials video and its impact on the informed consent process. Cancer 2012;118:1877-83.
Hutchison 2007 {published and unpublished data}
Jeste 2009 {published data only}
  • Jeste DV, Palmer BW, Golshan S, Eyler LT, Dunn LB, Meeks T, et al. Multimedia consent for research in people with schizophrenia and normal subjects: a randomized controlled trial. Schizophrenia Bulletin 2009;35:719-29.
Karunaratne 2010 {published and unpublished data}
  • Karunaratne AS, Korenman SG, Thomas SL, Myles PS, Komesaroff PA. Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants. Medical Journal of Australia 2010;192:388-92.
Kass 2009 {published data only (unpublished sought but not used)}
  • Daugherty C, Kass N, Fogarty LA, Sugarman J, Hlubocky F. A randomised trial of a CD-ROM educational intervention for advanced cancer patients enrolling in early phase trials. Proceedings of the American Society for Clinical Oncology 2003;22:521.
  • Hlubocky F, Kass N, Fogarty L. Effects of a CD-ROM educational intervention (CD) on prognosis (prog) understanding among advanced cancer patients (acp) enrolling in early phase clinical trials. Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings 2004;22(14(S)):6054.
  • Kass NE, Sugarman J, Medley AM, Fogarty LA, Taylor HA, Daugherty CK, et al. An intervention to improve cancer patients' understanding of early-phase clinical trials. IRB: Ethics & Human Research 2009;31(3):1-10.
Klein 2012 {published data only (unpublished sought but not used)}
  • Klein DW, Schartz HA. Instructional Strategies to Improve Informed Consent in Healthcare Research: Pilot Study of Interactivity and Multimedia. Paper presented at the American Educational Research Association National Conference Vancouver, Canada. April 2012.
Mittal 2007 {published and unpublished data}
  • Mittal D, Palmer B, Dunn L, Landes R, Ghormley C, Beck C, et al. Comparison of two enhanced consent procedures for patients with mild Alzheimer disease or mild cognitive impairment. American Journal of Geriatric Psychiatry 2007;15(2):163-7.
Norris 1990 {published data only}
  • Norris DR, Phillips MR. Using instructive videotapes to increase patient comprehension of informed consent. Journal of Clinical Research & Pharmacoepidemiology 1990;4(4):263-8.
O'Lonergan 2011 {published data only (unpublished sought but not used)}
  • O'Lonergan TA, Forster-Harwood JE. Novel approach to parental permission and child assent for research: improving comprehension. Pediatrics 2011;127:917-24.
Strevel 2007 {published and unpublished data}
  • Strevel EL, Newman C, Pond GR, MacLean M, Siu LL. The impact of an educational DVD on cancer patients considering participation in a phase I clinical trial. Supportive Care in Cancer 2007;15:829-40.
Weston 1997 {published and unpublished data}
  • Weston J, Downes J, Hannah M. Evaluating the benefits of patient video during the informed consent process. Controlled Clinical Trials. 1995; Vol. 16:73S (abstract).
  • Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Education & Counseling 1997;30(3):239-45.
Wirshing 2005 {published and unpublished data}
  • Mintz J, Wirshing DA, et al. cited in Agre 2003.
  • Wirshing DA, Mintz J, Kern R, Boyd J. A videotape intervention to enhance the informed consent process for patients participating in clinical research trial. Schizophrenia Research 2003;60:306.
  • Wirshing DA, Sergi MJ, Mintz J. A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research. American Journal of Psychiatry 2005;162(1):186-8.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. Additional references
  5. References to other published versions of this review
Barbour 1978 {published data only}
Benitez 2002 {published data only}
Benson 1985 {published data only}
Bickmore 2009 {published data only}
  • Bickmore TW, Pfeifer LM, Paasche-Orlow MK. Using computer agents to explain medical documents to patients with low health literacy. Patient Education and Counseling 2009;75:315-20.
  • National Institute of General Medical Sciences. Informed consent template for genetic repository research. available at: http://ccr.coriell.org/Sections/Support/NIGMS/Model.aspx?PgId=216 n.d. [2009].
Campbell 2008 {published data only}
  • Campbell HM, Raisch DW, Sather MR, Segal AR, Warren AR, Naik R. Impact of a clinical trials information handbook on patient knowledge, perceptions, and likelihood of participation. IRB: Ethics & Human Research 2008;30:6-14.
Curbow 2004 {published data only}
  • Curbow B, Fogarty LA, McDonnell K, Chill J, Scott LB. Can a brief video intervention improve breast cancer clinical trial knowledge and beliefs?. Social Science & Medicine 2004;58(1):193-205.
Dobscha 2005 {published data only}
  • Dobscha SK, Corson K, Solodky J, Gerrity MS. Use of videoconferencing for depression research: enrollment, retention, and patient satisfaction. Telemedicine Journal & E Health 2005;11:84-9.
Du 2008 {published data only}
Dunbar 1989 {published data only}
  • Dunbar J, Cleary PA, Siebert C, Baker L, Brink S, Nathan DM. Implementation of a multicomponent process to obtain informed consent in the Diabetes Control and Complications Trial. Controlled Clinical Trials 1989;10(1):83-96.
Dunlop 2011 {published data only}
  • Dunlop AL, Leroy ZC, Logue KM, Glanz K, Dunlop BW. Preconsent education about research processes improved African Americans' willingness to participate in clinical research. Journal of Clinical Epidemiology 2011;64:872-7.
Dunn 2001 {published and unpublished data}
  • Dunn LB, Lindamer LA, Palmer BW, Golshan S, Schneiderman LJ, Jeste DV. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. American Journal of Geriatric Psychiatry 2002;10(2):142-50.
  • Dunn LB, Lindamer LA, Palmer BW, Schneidermann LJ, Jeste DV. Enhancing comprehension of consent for research in older patients with psychosis: a randomised study of a novel consent procedure. American Journal of Psychiatry 2001;158(11):1911-3.
Flory 2004 {published data only}
Fureman 1997 {published data only}
  • Fureman I, Meyers K, McLellan AT, Metzger D, Woody G. Evaluation of a video-supplement to informed consent: injection drug users and preventive HIV vaccine efficacy trials. AIDS Education & Prevention 1997;9(4):330-41.
Gesualdo 2012 {published data only}
  • Gesualdo P, Ide L, Rewers M, Baxter J. Effectiveness of an informational video method to improve enrollment and retention of a pediatric cohort. Contemporary Clinical Trials 2012;33:273-8.
Goldberger 2011 {published data only}
  • Goldberger JJ, Kruse J, Kadish AH, Passman R, Bergner DW. Effect of informed consent format on patient anxiety, knowledge, and satisfaction. American Heart Journal 2011;162:780-5.
Hack 2007 {published data only}
Harzstark 2001 {published data only}
  • Harzstark AL, Schurman CR, Luce J, Carlson RW. Studying the effectiveness of videos in conveying medical information regarding breast cancer risks and the Study of Tamoxifen and Raloxifene (STAR) trial. Breast Cancer Research & Treatment 2001;69:268.
Hazen 2010 {published data only}
  • Hazen RA, Eder M, Drotar D, Zyzanski S, Reynolds AE, Reynolds CP, et al. Multi-Site Intervention Study to Improve Consent Research Team. A feasibility trial of a video intervention to improve informed consent for parents of children with leukemia. Pediatric Blood & Cancer 2010;55:113-8.
Hendrikson 2007 {published data only}
Henry 2009 {published data only}
  • Henry J, Palmer BW, Palinkas L, Glorioso DK Caligiuri MP, Jeste DV. Reformed consent: adapting to new media and research participant preferences. IRB: Ethics & Human Research 2009;31:1-8.
Hougham 2003a {published data only}
  • Hougham GW, Sachs GA, Danner D, Mintz J, Patterson M, Roberts LW, et al. Empirical research on informed consent with the cognitively impaired. IRB: Human Ethics and Research (Supplement) 2003;25:1-7.
Hultgren 2009 {published data only}
  • Hultgren B,  Zaghi S,  Carvas M,  Nascimento B,  Kwiatkowski J,  Fregni F. Challenges in consenting subjects for studies with brain stimulation: feasibility of multimedia video use during the informed consent process. Brain Stimulation 2009;2:174–8.
Ishii 2007 {published data only}
  • Ishii M, Ohashi Y. Influence of an educational videotape on attitudes toward participating in cohort studies--results of a randomized controlled trial. Japanese journal of public health 2007;54:419-26.
Jacobsen 2012 {published data only}
  • Jacobsen PB, Wells KJ, Meade CD, Quinn GP, Lee J, Fulp WJ, et al. Effects of a brief multimedia psychoeducational intervention on the attitudes and interest of patients with cancer regarding clinical trial participation: a multicenter randomized controlled trial. Journal of Clinical Oncology 2012;30:2516-21.
Jimison 1998 {published data only}
  • Jimison HB, Sher PP, Appleyard R, LeVernois Y. The use of multimedia in the informed consent process. Journal of the American Medical Informatics Association 1998;5(3):245-56.
Joseph 2006 {published data only}
  • Joseph P, Schakman BR, Horwitz R, Nerette S, Verdier RI, Dorsainvil D, et al. The use of an educational video during informed consent in an HIV clinical trial in Haiti. Journal of Acquired Immune Deficiency Syndromes 2006;42(5):588-91.
Kim 2008 {published data only}
  • Kim L, Young AJ, Neimeyer RA, Baker JN, Barfield R. Keeping users at the center: developing a multimedia interface for informed consent. Technical Communication Quarterly 2008;17:335-57.
Llewellyn-Thomas 1995 {published data only}
McGraw 2012 {published data only}
  • McGraw SA. Wood-Nutter CA, Solomon MZ, Maschke KJ, Benspm JT, Irwin DE. Clarity and appeal of a multimedia informed consent tool for biobanking. IRB: Ethics & Human Research 2012;34:9-19.
Moseley 2006 {published data only}
Moser 2006 {published data only}
  • Moser DJ, Reese RL, Hay CT, Schultz SK, Arndt S, Beglinger LJ, et al. Using a brief intervention to improve decisional capacity in schizophrenia research. Schizophrenia Bulletin 2006;32:116-20.
Palmer 2012 {published data only}
  • Palmer BW, Lanquette NM, Jeste DV. Effectiveness of multimedia aids to enhance comprehension of research consent information: a systematic review. IRB: Ethics & Human Research 2012 (Nov/Dec);34(6):1-15.
Quinn 2011 {published and unpublished data}
  • Quinn G, Wells K, Antonia T, Antolino P, Lopez N, Gonzalez L, et al. Abstract A30: Evaluating Spanish audiovisual materials about cancer clinical trials: improving awareness among Hispanic patients and families. Cancer Epidemiology Biomarkers and Prevention. 2011; Vol. 20:np. [DOI: 10.1158/1055-9965.DISP-11-A30]
Sahai 2007 {published data only}
Simes 1986 {published data only}
  • Simes J, Tattersall MHN, Coate AS, Raghavan D, Solomon HJ, Smartt H. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. BMJ 1986;293:1065-8.
Tindall 1994 {published data only}
  • Tindall B, Forde S, Ross MW, Goldstein D, Barker S, Cooper DA. Effects of two formats of informed consent on knowledge among persons with advanced HIV disease in a clinical trial of didanosine. Patient Education and Counseling 1994;24:261-6.
Varnhagen 2005 {published data only}
Wells 2012 {published data only}
  • Wells KJ, Quinn JP, Meade CD, Fletcher M, Martinez Tyson D, Jim H, et al. Development of a cancer clinical trials multi-media intervention: Clinical trials: Are they right for you?. Patient Education and Counseling 2012;88:232-40.
Wragg 2000 {published data only}
  • Wragg JA, Robinson EJ, Lilford RJ. Information presentation and decisions to enter clinical trials: a hypothetical trial of hormone replacement therapy. Social Science & Medicine 2000;51(3):453-62.

References to studies awaiting assessment

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. Additional references
  5. References to other published versions of this review
Hougham 2003b {published data only}
  • Hougham GW, Sachs GA, Danner D, Mintz J, Patterson M, Roberts L, et al. University of California at Los Angeles study. Cited in Hougham 2003: study not cited by name, authors, only by affiliation.
Rowbotham 2013 {published data only}
  • Rowbotham MC, Astin J, Greene K, Cummings SR. Interactive informed consent: randomized comparison with paper consents. PLoS ONE 2013;8:e58603.
Sonne 2013 {published data only}
  • Sonne SC, Andrews JO, Gentilin SM, Oppenheimer S, Obeid J, Brady K, et al. Development and pilot testing of a video-assisted informed consent process. Contemporary Clinical Trials 2013;36:25-31.

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. Additional references
  5. References to other published versions of this review
Agre 2003b
  • Agre P, Campbell FA, Goldman BD, Boccia ML, Kass N, McCullough LB, et al. Improving informed consent: the medium is not the message. IRB: Ethics and Human Research (Supplement) 2003;25(5):S11-19.
Appelbaum 2010
Ballard 2004
  • Ballard HO, Shook LA, Desai NS, Anand KJ. Neonatal research and the validity of informed consent obtained in the perinatal period. Journal of Perinatology 2004;24(7):409-15.
Breese 2007
  • Breese PE, Burman WJ, Goldberg S, Weis SE. Education level, primary language, and comprehension of the informed consent process. Journal of Empirical Research on Human Research Ethics 2007;2:69-79.
Brennan 2009
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Chan 2011
Chappuy 2006
Chuppay 2010
  • Chappuy H, Baruchel A, Leverger G, Oudot C, Brethon B, Haouy S, et al. Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia. Archives of Disease in Childhood 2010;95:800-4.
Cohn 2007
Dunn 2001a
  • Dunn LB, Lindamer LA, Schneiderman LJ, Jeste DV. A novel, computer-based enhancement of informed consent in older patients with psychotic disorders. 14th Annual Meeting of the American Association for Geriatric Psychiatry. San Francisco, CA, USA, 2001 23rd-26th February.
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References to other published versions of this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. Additional references
  5. References to other published versions of this review
McLaughlin 2002
  • McLaughlin KJ, Brindley AF, Crowther CA. Informational video for potential participants of clinical studies used in the process of seeking informed consent. Cochrane Database of Systematic Reviews 2002, Issue 3. [DOI: 10.1002/14651858.CD003717]
Ryan 2008