Table 1. Description of the studies included in the systematic review (full reference information is provided below the table)
Author, year
|
Consent for
|
Population
|
Intervention
|
Continent
|
Bergenmar 20141
|
RCT
|
adult
|
multimedia non interactive
|
Europe
|
Beulen 20162
|
Diagnostic
|
adult
|
multimedia interactive
|
Europe
|
Blake 20153
|
RCT
|
adolescent
|
multimedia interactive
|
North America
|
Gordon 20164
|
Surgery
|
adult
|
multimedia interactive
|
North America
|
Hall 20175
|
RCT
|
adult
|
video
|
North America
|
Krishnamurti 20166
|
RCT
|
adult
|
video
|
North America
|
McCaughey 20167
|
Therapy/vaccine
|
adult
|
multimedia interactive
|
Oceania
|
Mednick 20168
|
Surgery
|
adult
|
video
|
North America
|
Pot 20179
|
Therapy/vaccine
|
adult
|
multimedia non interactive
|
Europe
|
Warriner 201610
|
RCT
|
adult
|
multimedia interactive
|
North America
|
Winter 201611
|
Surgery
|
adult
|
video
|
Oceania
|
Yin 201512
|
Surgery
|
adult
|
multimedia non interactive
|
North America
|
Roberts 201613
|
Surgery
|
adult
|
multimedia interactive
|
North America
|
Rowbotham 201314
|
RCT
|
adult
|
multimedia interactive
|
North America
|
Afolabi 201515
|
RCT
|
adult
|
multimedia non interactive
|
Africa
|
Baenninger P 201816
|
Surgery
|
adult
|
video
|
Europe
|
Bethune 201817
|
Surgery
|
adult
|
multimedia interactive
|
North America
|
Castelnuovo B 201518
|
RCT
|
adult
|
multimedia interactive
|
Africa
|
Ellett 201419
|
Surgery
|
adult
|
multimedia non interactive
|
Oceania
|
Fraval 201520
|
Surgery
|
adult
|
multimedia interactive
|
Oceania
|
Günay 201521
|
Diagnostic
|
adult
|
multimedia non interactive
|
Asia
|
Ham 201622
|
Surgery
|
adult
|
multimedia non interactive
|
Asia
|
Harmell 201223
|
RCT
|
adult
|
multimedia interactive
|
North America
|
Huber 201324
|
Surgery
|
adult
|
multimedia interactive
|
Europe
|
Ohman 201225
|
Diagnostic
|
adult
|
video
|
Europe
|
Prochazka 201426
|
Surgery
|
adult
|
multimedia non interactive
|
North America
|
Siu 201627
|
Surgery
|
adult
|
multimedia interactive
|
North America
|
Tait 201428
|
Surgery
|
adult
|
multimedia interactive
|
North America
|
Tait 201529
|
RCT
|
children
|
multimedia interactive
|
North America
|
Tipotsch-Maca 201630
|
Surgery
|
adult
|
video
|
Europe
|
Vo 201831
|
Diagnostic
|
adult
|
video
|
North America
|
Palmer 201732
|
Therapy/vaccine
|
adult
|
video
|
North America
|
Pawlak 201533
|
Therapy/vaccine
|
adolescent
|
multimedia non interactive
|
North America
|
Rothwell 201434
|
RCT
|
adult
|
video
|
North America
|
Schlechtweg 201435
|
Diagnostic
|
adult
|
multimedia interactive
|
Europe
|
Simon 201536
|
Diagnostic
|
adult
|
multimedia interactive
|
North America
|
Shelton 201537
|
RCT
|
adult
|
multimedia non interactive
|
North America
|
Spencer 201538
|
Therapy/vaccine
|
children
|
multimedia non interactive
|
North America
|
1 Bergenmar M, Johansson H, Wilking N, Hatschek T, Brandberg Y. Audio-recorded information to patients considering participation in cancer clinical trials - A randomized study. Acta Oncol (Madr). 2014;
2 Beulen L, Van Den Berg M, Faas BH, Feenstra I, Hageman M, Van Vugt JM, et al. The effect of a decision aid on informed decision-making in the era of non-invasive prenatal testing: A randomised controlled trial. Eur J Hum Genet. 2016;
3 Blake DR, Lemay CA, Maranda LS, Fortenberry JD, Kearney MH, Mazor KM. Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial. AIDS Care 2015;
4 Gordon EJ, Sohn M-W, Chang C-H, McNatt G, Vera K, Beauvais N, et al. Effect of a Mobile Web App on Kidney Transplant Candidatesʼ Knowledge About Increased Risk Donor Kidneys. Transplantation. 2016;
5 Hall EW, Sanchez TH, Stein AD, Stephenson R, Zlotorzynska M, Sineath RC, et al. Use of videos improves informed consent comprehension in web-based surveys among internet-using men who have sex with men: A randomized controlled trial. J Med Internet Res. 2017;
6 Krishnamurti T, Argo N. A patient-centered approach to informed consent: Results from a survey and randomized trial. Med Decis Mak. 2016;
7 McCaughey T, Liang HH, Chen C, Fenwick E, Rees G, Wong RCB, et al. An Interactive Multimedia Approach to Improving Informed Consent for Induced Pluripotent Stem Cell Research. Cell Stem Cell. 2016;
8 Mednick Z, Irrcher I, Hopman WM, Sharma S. Assessing a narrated white board animation as part of the consent process for intravenous fluorescein angiography: a randomized educational study. Can J Ophthalmol. 2016;
9 Pot M, Paulussen TGWM, Ruiter RAC, Eekhout I, De Melker HE, Spoelstra MEA, et al. Effectiveness of a web-based tailored intervention with virtual assistants promoting the acceptability of hpv vaccination among mothers of invited girls: Randomized controlled trial. J Med Internet Res. 2017;
10 Warriner AH, Foster PJ, Mudano A, Wright NC, Melton ME, Sattui SE, et al. A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study. Contemp Clin Trials Commun. 2016;
11 Winter M, Kam J, Nalavenkata S, Hardy E, Handmer M, Ainsworth H, Lee WG, Louie-Johnsun M. The use of portable video media vs standard verbal communication in the urological consent process: a multicenter, randomized controlled, crossover trial. BJU Int. 2016;
12 Yin B, Goldsmith L, Gambardella R. Web-based education prior to knee arthroscopy enhances informed consent and patient knowledge recall: A prospective, randomized controlled study. J Bone Jt Surg - Am Vol. 2015;
13 Roberts KJ, Revenson TA, Urken ML, Fleszar S, Cipollina R, Rowe ME, et al. Testing with feedback improves recall of information in informed consent: A proof of concept study. Patient Educ Couns. 2016;
14 Rowbotham MC, Astin J, Greene K, Cummings SR. Interactive Informed Consent: Randomized Comparison with Paper Consents. PLoS One. 2013;
15 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;
16 Baenninger PB, Faes L, Kaufmann C, Reichmuth V, Bachmann LM, Thiel MA. Efficiency of video-presented information about eximer laser treatment on ametropic patients’ knowledge and satisfaction with the informed consent process. J Cataract refract Surg 2018;
17 Bethune A, Davila-Foyo M, Valli M, Da Costa L. E-Consent: Approaching surgical consent with mobile technology. Can J Surg. 2018;
18 Castelnuovo B. Multi-media Educational Tool Increases Knowledge of Clinical Trials in Uganda. J Clin Res Bioeth. 2014;
19 Ellett L, Villegas R, Beischer A, Ong N, Maher P. Use of a Multimedia Module to Aid the Informed Consent Process in Patients Undergoing Gynecologic Laparoscopy for Pelvic Pain: Randomized Controlled Trial. J Minim Invasive Gynecol. 2014;
20 Fraval A, Chandrananth J, Chong YM, Tran P, Coventry LS. Internet based patient education improves informed consent for elective orthopaedic surgery: A randomized controlled trial. BMC Musculoskelet Disord. 2015;
21 Gunay E, Baki ED, Kokulu S, Ulasli SS, Oz G, Akar O, et al. Impact of multimedia information on bronchoscopy procedure: is it really helpful? Ann Thorac Med. 2015;
22 Ham DY, Choi WS, Song SH, Ahn Y-J, Park HK, Kim HG, et al. Prospective Randomized Controlled Study on the Efficacy of Multimedia Informed Consent for Patients Scheduled to Undergo Green-Light High-Performance System Photoselective Vaporization of the Prostate. World J Mens Health. 2016;
23 Harmell AL, Palmer BW, Jeste D V. Preliminary study of a web-based tool for enhancing the informed consent process in schizophrenia research. Schizophr Res. 2012;
24 Huber J, Ihrig A, Yass M, Bruckner T, Peters T, Huber CG, et al. Multimedia support for improving preoperative patient education: A randomized controlled trial using the example of radical prostatectomy. Ann Surg Oncol. 2013;
25 Öhman SG, Björklund U, Marsk A. Does an informational film increase women’s possibility to make an informed choice about second trimester ultrasound? Prenat Diagn. 2012;
26 Prochazka A V, Fink AS, Bartenfeld D, Henderson WG, Nyirenda C, Webb A, et al. Patient Perceptions of Surgical Informed Consent: Is Repeat Back Helpful or Harmful? J Patient Saf. 2014;
27 Siu JM, Rotenberg BW, Franklin JH, Sowerby LJ. Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial. In: Laryngoscope. 2016.
28 Tait AR, Voepel-Lewis T, Chetcuti SJ, Brennan-Martinez C, Levine R. Enhancing patient understanding of medical procedures: Evaluation of an interactive multimedia program with in-line exercises. Int J Med Inform. 2014;
29 Tait AR, Voepel-Lewis T, Levine R. Using digital multimedia to improve parents’ and children’s understanding of clinical trials. Archives of Disease in Childhood. 2015.
30 Tipotsch-Maca SM, Varsits RM, Ginzel C, Vecsei-Marlovits P V. Effect of a multimedia-assisted informed consent procedure on the information gain, satisfaction, and anxiety of cataract surgery patients. J Cataract Refract Surg. 2016;
31 Vo TA, Ngai P, Tao JP. A randomized trial of multimedia-facilitated informed consent for cataract surgery. Clinical Ophthalmology 2018.
32 Palmer BW, Harmell AL, Dunn LB, Kim SY, Pinto LL, Golshan S, et al. Multimedia Aided Consent for Alzheimer’s Disease Research. Clin Gerontol. 2017;
33 Pawlak CE, Fields HW, Beck FM, Firestone AR. Orthodontic informed consent considering information load and serial position effect. Am J Orthod Dentofac Orthop. 2015;
34 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;
35 Schlechtweg PM, Hammon M, Giese D, Heberlein C, Uder M, Schwab SA. IPad-based patient briefing for radiological examinations - A clinical trial. J Digit Imaging. 2014;
36 Simon CM, Klein DW, Schartz HA. Interactive multimedia consent for biobanking: A randomized trial. Genet Med. 2016;
37 Shelton AK, Freeman BD, Fish AF, Bachman JA, Richardson LI. A computer-based education intervention to enhance surrogates’ informed consent for genomics research. Am J Crit Care 2015;
38 Spencer SP, Stoner MJ, Kelleher K, Cohen DM. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department. Pediatr Emerg Care. 2015;
Table 2. Number of studies in which digital interventions had a positive effect by outcome (articles explored more than one outcome).
|
Outcome
|
Comprehension
|
Knowledge
|
Acceptance
|
Anxiety
|
Satisfaction
|
Participation
|
Type of study:
|
RCT
|
C/S*
|
RCT
|
C/S*
|
RCT
|
C/S*
|
RCTs
|
C/S*
|
RCT
|
C/S*
|
RCT
|
C/S*
|
Video
|
1/3
|
2/4
|
0/1
|
1/3
|
0/0
|
0/2
|
0/0
|
1/2
|
0/0
|
2/5
|
0/1
|
0/1
|
Multimedia non interactive
|
2/3
|
1/3
|
0/1
|
3/4
|
0/0
|
1/1
|
0/0
|
1/2
|
0/0
|
3/5
|
0/0
|
1/1
|
Multimedia interactive
|
5/6
|
4/4
|
1/1
|
5/6
|
0/0
|
0/0
|
0/0
|
0/1
|
2/3
|
3/3
|
1/2
|
1/2
|
Total studies by outcome and study type
|
12
|
11
|
3
|
13
|
0
|
3
|
0
|
5
|
3
|
13
|
3
|
4
|
Total studies by outcome
|
23
|
16
|
3
|
5
|
16
|
7
|
*C/S = clinical or surgical