A cognitive approach for design of a multimedia informed consent video and website in pediatric research

Protection of Human Subjects, Subpart D, 45 Code of Federal Regulations §46.408, 2009. Cuttini, 2000, Proxy informed consent in pediatric research: a review, Early Hum. Dev., 60, 89, 10.1016/S0378-3782(00)00106-7 Rossi, 2003, Child assent and parental permission in pediatric research, Theor. Med. Bioeth., 24, 131, 10.1023/A:1024690712019 Tait, 2003, Do they understand? (Part I): parental consent for children participating in clinical anesthesia and surgery research, Anesthesiology, 98, 603, 10.1097/00000542-200303000-00005 Tait, 2003, Do they understand? (Part II): assent of children participating in clinical anesthesia and surgery research, Anesthesiology, 98, 609, 10.1097/00000542-200303000-00006 Stryker, 2006, Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret, Patient Educ. Couns., 63, 104, 10.1016/j.pec.2005.09.006 Hallinan, 2016, Barriers to change in the informed consent process: a systematic literature review, IRB, 38, 1 Ballard, 2011, Parents' understanding and recall of informed consent information for neonatal research, IRB, 33, 12 Davis, 1998, Informed consent for clinical trials: a comparative study of standard versus simplified forms, J. Natl. Cancer Inst., 90, 668, 10.1093/jnci/90.9.668 Flory, 2004, Interventions to improve research participants' understanding in informed consent for research: a systematic review, JAMA, 292, 1593, 10.1001/jama.292.13.1593 Campbell, 2004, 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 Educ. Couns., 53, 205, 10.1016/S0738-3991(03)00162-9 Palmer, 2012, Effectiveness of multimedia aids to enhance comprehension of research consent information: a systematic review, IRB, 34, 1 Bickmore, 2009, Using computer agents to explain medical documents to patients with low health literacy, Patient Educ. Couns., 75, 315, 10.1016/j.pec.2009.02.007 Shneerson, 2013, Innovating information-delivery for potential clinical trials participants. What do patients want from multi-media resources?, Patient Educ. Couns., 90, 111, 10.1016/j.pec.2012.06.031 Rowbotham, 2013, Interactive informed consent: randomized comparison with paper consents, PLoS ONE, 8, e58603, 10.1371/journal.pone.0058603 Farrell, 2014, Systematic review and meta-analysis of audio-visual information aids for informed consent for invasive healthcare procedures in clinical practice, Patient Educ. Couns., 94, 20, 10.1016/j.pec.2013.08.019 O'Lonergan, 2011, Novel approach to parental permission and child assent for research: improving comprehension, Pediatrics, 127, 917, 10.1542/peds.2010-3283 Nishimura, 2013, Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials, BMC Med. Ethics, 14, 28, 10.1186/1472-6939-14-28 Clark, 2011 Mayer, 2009 Mayer, 2003, Nine ways to reduce cognitive load in multimedia learning, Educ. Psychol., 38, 43, 10.1207/S15326985EP3801_6 Paas, 1992, Training strategies for attaining transfer of problem-solving skill in statistics: a cognitive-load approach, J. Educ. Psychol., 84, 429, 10.1037/0022-0663.84.4.429 Tabbers, 2004, Multimedia instructions and cognitive load theory: effects of modality and cueing, Br. J. Educ. Psychol., 74, 71, 10.1348/000709904322848824 Bandura, 1986 Levine, 1975 Baddeley, 1999, Working memory and vigilance: evidence from normal aging and Alzheimer's disease, Brain Cogn., 41, 87, 10.1006/brcg.1999.1097 Mayer, 2005, The case for coherence in scientific explanations: quantitative details can hurt qualitative understanding, J. Exp. Psychol. Appl., 11, 13, 10.1037/1076-898X.11.1.13 Sanchez, 2006, An examination of the seductive details effect in terms of working memory capacity, Memory Cogn., 34, 344, 10.3758/BF03193412 Mayer, 2002, Fostering understanding of multimedia messages through pre-training: evidence for a two-stage theory of mental model construction, J. Exp. Psychol.: Appl., 8, 147 Mayer, 2005, Principles for reducing extraneous processing in multimedia learning: coherence, signaling, redundancy, spatial contiguity, and temporal contiguity principles, 183 Moreno, 2002, Verbal redundancy in multimedia learning: when reading helps listening, J. Educ. Psychol., 94, 156, 10.1037/0022-0663.94.1.156 Clarebout, 2002, Animated pedagogical agents: an opportunity to be grasped?, J. Educ. Multimedia Hypermedia, 11, 267+ Mayer, 2005, Principles of multimedia learning based on social cues: personalization, voice, and image principles, 201 Moreno, 2005, Multimedia learning with animated pedagogical agents, 507 Schroeder, 2012, Case for the use of Pedagogical Agents in Online Learning Environments, J. Teach. Learn. Technol., 1, 43 Protection of Human Subjects, Subpart A, Code of Federal Regulations, 2009. Electronic Records, Electronic Signatures, Code of Federal Regulations, 1997. Wysocki, 2016, Consideration of insulin pumps or continuous glucose monitors by adolescents with type 1 diabetes and their parents: stakeholder engagement in the design of web-based decision aids, Diab. Educ., 42, 395, 10.1177/0145721716647492 Sudore, 2006, Use of a modified informed consent process among vulnerable patients: a descriptive study, J. Gen. Intern. Med., 21, 867, 10.1111/j.1525-1497.2006.00535.x Harris, 2009, Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support, J. Biomed. Inform., 42, 377, 10.1016/j.jbi.2008.08.010 Pfizer, Inc., The Newest Vital Sign: A New Health Literacy Assessment Tool for Health Care Providers. Weiss, 2005, Quick assessment of literacy in primary care: the newest vital sign, Ann. Fam. Med., 3, 514, 10.1370/afm.405 Shah, 2010, Health literacy instrument in family medicine: the “newest vital sign” ease of use and correlates, J. Am. Board Fam. Med., 23, 195, 10.3122/jabfm.2010.02.070278 Driessnack, 2014, Using the “Newest Vital Sign” to assess health literacy in children, J. Pediatr. Health Care, 28, 165, 10.1016/j.pedhc.2013.05.005 Warsh, 2014, Can the Newest Vital Sign be used to assess health literacy in children and adolescents?, Clin. Pediatr. (Phila), 53, 141, 10.1177/0009922813504025 Morrison, 2014, Measuring health literacy in caregivers of children: a comparison of the newest vital sign and S-TOFHLA, Clin. Pediatr. (Phila), 53, 1264, 10.1177/0009922814541674 Blake, 2015, Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: study design and rationale, Contemp. Clin. Trials, 42, 105, 10.1016/j.cct.2015.03.012 McGraw, 2012, Clarity and appeal of a multimedia informed consent tool for biobanking, IRB, 34, 9 Nehme, 2013, The use of multimedia consent programs for surgical procedures: a systematic review, Surg. Innov., 20, 13, 10.1177/1553350612446352 Schnellinger, 2010, Animated video vs pamphlet: comparing the success of educating parents about proper antibiotic use, Pediatrics, 125, 990, 10.1542/peds.2009-2916 Spencer, 2015, Using a multimedia presentation to enhance informed consent in a pediatric emergency department, Pediatr. Emerg. Care, 31, 572, 10.1097/PEC.0000000000000513 Tait, 2014, Enhancing patient understanding of medical procedures: evaluation of an interactive multimedia program with in-line exercises, Int. J. Med. Inform., 83, 376, 10.1016/j.ijmedinf.2014.01.011 Tait, 2015, Using digital multimedia to improve parents' and children's understanding of clinical trials, Arch. Dis. Child., 100, 589, 10.1136/archdischild-2014-308021 Tamariz, 2013, Improving the informed consent process for research subjects with low literacy: a systematic review, J. Gen. Intern. Med., 28, 121, 10.1007/s11606-012-2133-2 Jeste, 2009, Multimedia consent for research in people with schizophrenia and normal subjects: a randomized controlled trial, Schizophr. Bull., 35, 719, 10.1093/schbul/sbm148 Americans’ Internet Access: 2000–2015, Pew Research Center, Washington, DC, 2015. Lorell, 2015, Informed consent in clinical research: consensus recommendations for reform identified by an expert interview panel, Clin. Trials, 12, 692, 10.1177/1740774515594362 Hein, 2014, Accuracy of the MacArthur competence assessment tool for clinical research (MacCAT-CR) for measuring children's competence to consent to clinical research, JAMA Pediatr., 168, 1147, 10.1001/jamapediatrics.2014.1694 Ellaway, 2011, Reflecting on multimedia design principles in medical education, Med. Educ., 45, 766, 10.1111/j.1365-2923.2011.04064.x Issa, 2011, Applying multimedia design principles enhances learning in medical education, Med. Educ., 45, 818, 10.1111/j.1365-2923.2011.03988.x