Strategies to favor comprehension of the consent form by clinical trial participants: an integrative review
DOI:
https://doi.org/10.5216/ree.v25.70441Keywords:
Comprehension, Informed Consent, Clinical TrialAbstract
Objective: to analyze the strategies used to favor the comprehension of clinical trial participants about the informed consent form, as well as the theoretical bases on which these are based. Methods: integrative literature review performed in 2019 and updated in 2021 in six electronic databases, plus a reverse search based on references of the included articles. Results: strategies of changing the content and the form of presentation of the consent form, as well as multimodal strategies were identified in the 21 selected articles. The identified strategies are mostly related to the traditional learning framework and resulted in a better understanding by individuals in the process of obtaining consent to participate in clinical trials, compared to the usual strategies. For the most part, the level of comprehension remained below 60.0%. Conclusions: the strategies resulted in an improvement in general understanding, although with persisting misunderstanding or limited understanding of fundamental concepts inherent to participation in clinical trials, reinforcing that the process of obtaining consent is a complex phenomenon that requires special attention from researchers, in the quest to ensure proper understanding of information, and an actually informed decision-making.
Downloads
References
ClinicalTrials.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine. 2000 [cited 2023 Mar 07]. Available from: https://clinicaltrials.gov
Cordeiro MD, Sampaio HAC. Aplicação dos fundamentos do letramento em saúde no consentimento informado. Rev. Bioét. 2019 July-Sept;27(3):410-8. https://doi.org/10.1590/1983-80422019273324
Cosac DCS. Autonomia, consentimento e vulnerabilidade do participante de pesquisa clínica. Rev. Bioét. 2017 Jan-Apr;25(1):19-29. https://doi.org/10.1590/1983-80422017251162
Jungues JR. Exigências éticas do consentimento informado [Internet]. Rev. Bioét. 2007 [cited 2023 Mar 07];15(1):77-82. Available from: https://revistabioetica.cfm.org.br/index.php/revista_bioetica/article/viewFile/32/35
Beauchamp TL, Childress JF. Princípios de ética biomédica. 4th ed. São Paulo (SP): Edições Loyola; 2001.
Ranjan R, Agarwal NB, Kapur P, Marwah A, Parveen R. Study of Awareness and Practice of Informed. Asia-Pac J Public Health. 2019 Nov 03;31(8):710-8. https://doi.org/10.1177/1010539519883135
Bader M, Zheng L, Rao D, Shiyanbola O, Myers L, Davis T, et al. Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices. Contemp Clin Trials. 2022 May;116:106733. https://doi.org/10.1016/j.cct.2022.106733
Gesualdo F, Daverio M, Palazzani, L, Dimitriou D, Diez-Domingo J, Fons-Martinez J, et al. Digital tools in the informed consent process: a systematic review. BMC Med Ethics. 2021 Feb 27;22:18. https://doi.org/10.1186/s12910-021-00585-8
Gazzinelli MF, Soares AN, Carneiro ACLL, Diemert D. Intercessões entre pesquisa clínica e educação: por uma promoção de conhecimento inventiva. 1st ed. Curitiba (PR): Editora CRV; 2018. https://doi.org/10.24824/978854442031.7
Rothwell E, Wong B, Rose NC, Anderson R, Fedor B, Stark LA, et al. A randomized controlled trial of an electronic informed consent process. J Empir Res Hum Res Ethics. 2014 Oct 02;9(5):1-7. https://doi.org/10.1177/1556264614552627
Quevedo A, Condo C, Valenzuela G, Molina L, Castillo E, Palacio A, et al. Informed consent comprehension among vulnerable populations in Ecuador: video-delivered vs. in-person standard method. Account Res. 2018 May 15;25(5):259-72. https://doi.org/10.1080/08989621.2018.1470931
Dickert NW, Eyal N, Goldkind SF, Grady C, Joffe S, Lo B, et al. Reframing Consent for Clinical Research: A Function-Based Approach. Am J Bioeth. 2017 Nov 17;17(12):3-11. https://doi.org/10.1080/15265161.2017.1388448
Paris A, Deygas B, Cornu C, Thalamas C, Maison P, Duale C, et al. Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings. Br J Clin Pharmacol. 2015 July 03;80(5):1010-20. https://doi.org/10.1111/bcp.12716
Meneguin S, Ayres JA. Percepção do termo de consentimento informado pelos participantes dos ensaios clínicos [Internet]. Invest Educ Enferm. 2014 Jan-Apr;32(1):95-102. https://doi.org/10.17533/udea.iee.v32n1a11
Hopia H, Latvala E, Liimatainen L. Reviewing the methodology of an integrative review. Scand J Caring Sci. 2016 Apr 14;30(4):662-9. https://doi.org/10.1111/scs.12327
Mendes KDS, Silveira RCCP, Galvão CM. Revisão integrativa: método de pesquisa para a incorporação de evidências na saúde e na enfermagem. Texto contexto – enferm. 2008 Oct-Dez;17(4):758-64. https://doi.org/10.1590/S0104-07072008000400018
Santos CMC, Pimenta CAM, Nobre MRC. A estratégia PICO para a construção da pergunta de pesquisa e busca de evidências. Rev. Latino-Am. Enfermagem. 2007 June;15(3):508-11. https://doi.org/10.1590/S0104-11692007000300023
Libâneo JC. As Teorias Pedagógicas Modernas Revisitadas pelo Debate Contemporâneo na Educação. In: Libâneo JC, Santos A. A Educação na Era do Conhecimento em Rede e Transdisciplinaridade. 2nd ed. Campinas: Alínea; 2009. p. 1-37
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021 Mar 29;372:n71. https://doi.org/10.1136/bmj.n71
Tindall B, Forde S, Ross MW, Goldstein D, Barker S, Cooper DA. Effects of two formats of informed consent on knowledge amongst persons with advanced HIV disease in a clinical trial of didanosine. Patient Educ Couns. 1994 Dec;24(3):261-6. https://doi.org/10.1016/0738-3991(94)90069-8
Benatar JR, Mortimer J, Stretton M, Stewart RA. A booklet on participants’ rights to improve consent for clinical research: a randomized trial. PLoS One. 2012 Oct 19;7(10):e47023. https://doi.org/10.1371/journal.pone.0047023
Koonrungsesomboon N, Teekachunhatean S, Hanprasertpong N, Laothavorn J. Improved participants’ understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study. Eur J Clin Pharmacol. 2016 Apr;72(4):413-21. https://doi.org/10.1007/s00228-015-2000-2
Koonrungsesomboon N, Tharavanij T, Phiphatpatthamaamphan K, Vilaichone RK, Manuwong S, Curry P, et al. Improved participants’ understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials. Eur J Clin Pharmacol. 2017 Feb;73(2):141-9. https://doi.org/10.1007/s00228-016-2159-1
Koonrungsesomboon N, Traivaree C, Tiyapsane C, Karbwang J. Improved parental understanding by an enhanced informed consent form: A randomized controlled study nested in a paediatric drug trial. BMJ Open. 2019 Nov 26;9(11):e029530. https://doi.org/10.1136/bmjopen-2019-029530
Aaronson NK, Visser-Pol E, Leenhouts GH, Muller MJ, Van der Schot AC, Van Dam FS, et al. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol. 1996 Mar 01;14(3):984-96. https://doi.org/10.1200/JCO.1996.14.3.984
Hutchison C, Cowan C, McMahon T, Paul J. A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. Br J Cancer. 2007 Sept 11;97(6):705-11. https://doi.org/10.1038/sj.bjc.6603943
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. Support Care Cancer. 2007;15(7):829-40. https://doi.org/10.1007/s00520-006-0199-2
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 [Internet]. 2009 May-June [cited 2023 Mar 07];31(3):1-10. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2872090/pdf/nihms196466.pdf
Sengupta S, Lo B, Strauss RP, Eron J, Gifford AL. Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials. AIDS Care. 2011 Nov;23(11):1382-91. https://doi.org./10.1080/09540121.2011.565031
Jeong IS, Hong JH, Jung SK, Cho J. The effect of feedback with photo-novella information sheets on subjects’ understanding in informed consent for research. Ther Innov Regul Sci. 2012;46(6)661-8. https://doi.org/10.1177/0092861512456837
Lobato L, Souza VD, Caçador B, Soares AN, Wingester ELC, Gazzinelli MF. Efeitos de intervenção educativa na qualidade ética do consentimento livre e esclarecido. Rev. Bioét. 2012 [cited 2023 Mar 07];20(3):479-89. Available from: https://revistabioetica.cfm.org.br/index.php/revista_bioetica/article/view/769/821
Ndebele PM, Wassenaar D, Munalula E, Masiye F. Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi. BMC Med Ethics. 2012 Nov 08;13:29. https://doi.org/10.1186/1472-6939-13-29
Festinger DS, Dugosh K, Marlowe DB, Clements NT. Achieving new levels of recall in consent to research by combining remedial and motivational techniques. J Med Ethics. 2014 Mar 18;40(4):264-8. https://doi.org/10.1136/medethics-2012-101124
Kass NE, Taylor HA, Ali J, Hallez K. A pilot study of simple interventions to improve informed consent in clinical research: Feasibility, approach, and results. Clin Trials. 2015 Feb;12(1):54-66. https://doi.org/10.1177/1740774514560831
Afolabi MO, McGrath N, D’Alessandro U, Kampmann B, Imoukhuede EB, Ravinetto RM, et al. A multimedia consent tool for research participants in the Gambia: a randomized controlled trial. Bull World Health Organ. 2015 Mar 23;93(5):320-8A. https://doi.org/10.2471/BLT.14.146159
Tait AR, Voepel-Lewis T, Levine R. Using digital multimedia to improve parents’ and children’s understanding of clinical trials. Arch Dis Child. 2015 May 18;100(6):589-93. https://doi.org/10.1136/archdischild-2014-308021
Simon CM, Klein DW, Schartz HA. Interactive multimedia consent for biobanking: a randomized trial. Genet Med. 2016 Jan;18(1):57-64. https://doi.org/10.1038/gim.2015.33
Annett RD, Brody JL, Scherer DG, Turner CW, Dalen J, Raissy H. A randomized study of a method for optimizing adolescent assent to biomedical research. AJOB Empir Bioeth. 2017;8(3):189-97. https://doi.org/10.1080/23294515.2016.1251507
Chalela P, Muñoz E, Gallion KJ, Kaklamani V, Ramirez AG. Empowering Latina breast cancer patients to make informed decisions about clinical trials: a pilot study. Transl Behav Med. 2018 June;8(3):439-49. https://doi.org/10.1093/tbm/ibx083
Palmeirim MS, Ross A, Obrist B, Mohammed UA, Ame SM, Ali SM, et al. Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers’ knowledge?. BMC Med Ethics. 2020 Jan 06;21(1):1-9. https://doi.org/10.1186/s12910-019-0441-3
Associação da Indústria Farmacêutica de Pesquisa (Interfarma). A importância da pesquisa clínica para o Brasil [Internet]. São Paulo: Interfarma; 2021 [cited 2023 Mar 07]. Available from: https://www.interfarma.org.br/wp-content/uploads/2021/12/Interfarma_Estudo-Pesquisa-clinica-2021-1.pdf
Gomes ATL, Salvador PTCO, Goulart CF, Cecilio SG, Bethony MFG. Innovative Methodologies to Teach Patient Safety in Undergraduate Nursing: Scoping Review. Aquichan. 2020 Jan-Mar;20(1):e2018. https://doi.org/10.5294/aqui.2020.20.1.8
Carvalho ICN, Nascimento MOF, Pinto ACS, Melo ERF, Carvalho GRN, Santos MCT. Educational technology: Nursing and educational games in health education. RSD. 2021 June 15;18;10(7):e18710716471. https://doi.org/10.33448/rsd-v10i7.16471
Sanchez K, Eghaneyan BH, Killian MO, Calabassa LJ, Trivedi MH. Depression education fotonovela for engagement of Hispanic patients in treatment: a randomized clinical trial. BMC Psychiatry. 2021 Dec 23;21:635. https://doi.org/10.1186/s12888-021-03641-0
Bhupathi PA, Ravi GR. Comprehensive Format of Informed Consent in Research and Practice: A Tool to uphold the Ethical and Moral Standards. Int J Clin Pediatr Dent. 2017 Jan-Mar;10(1):73-81. https://doi.org/10.5005/jp-journals-10005-1411
Nascimento TG. Avaliação do processo de consentimento de pesquisa clínica [Tese na Internet]. [Ribeirão Preto]: Universidade de São Paulo; 2017 [cited 2023 Mar 07]. Available from: https://doi.org/10.11606/T.22.2018.tde-28112017-162459
Kadam RA. Informed consent process: A step further towards making it meaningful!. Perspect Clin Res. 2017 July-Sept [cited 2023 Mar 07];8(3):107-12. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543760
Rodrigues E Filho, Prado MM, Prudente COM. Compreensão e legibilidade do termo de consentimento livre e esclarecido em pesquisas clínicas. Rev. Bioét. 2014 Aug;22(2):325-36. https://doi.org/10.1590/1983-80422014222014
Almeida CH, Marques RC, Reis DC, Melo JMC, Diemert D, Gazzinelli MF. A pesquisa científica na saúde: uma análise sobre a participação de populações vulneráveis. Texto contexto - enferm. 2010 Mar;19(1):104-11. https://doi.org/10.1590/S0104-07072010000100012
Zagaja A. Quality of informed consent in clinical trials. J Pre Clin Res. 2020;14(1):22-4. https://doi.org/10.26444/jpccr/119621
Amorim KPC, Garrafa V, Melo AD, Costa AVB, Oliveira GCL, Lopes HG, et al. Participantes de ensaios clínicos em oncologia: perfil e aspectos envolvidos nas suas decisões. Trab. educ. saúde. 2018 Sept-Dec;16(3):1381-402. https://doi.org/10.1590/1981-7746-sol00139
Lobato L, Gazzinelli MF, Gazzinelli A, Soares AN. Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico. Cad. Saúde Pública. 2014 June;30(6):1305-14. https://doi.org/10.1590/0102-311X00127813
Simonds VW, Garroutte EM, Buchwald D. Health Literacy and Informed Consent Materials: Designed for Documentation, Not Comprehension of Health Research. J Health Commun. 2017 July 31;22(8):682-91. https://doi.org/10.1080/10810730.2017.1341565
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2023 Revista Eletrônica de Enfermagem
This work is licensed under a Creative Commons Attribution 4.0 International License.
