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

Abstract

The value of audio-visual interventions as a tool for helping to enhance the informed consent process for people considering participating in clinical trials remains largely unclear, although trends are emerging with regard to improvements in knowledge and satisfaction. Many relevant outcomes have not been evaluated in randomised trials. Triallists should continue to explore innovative methods of providing information to potential trial participants during the informed consent process, mindful of the range of outcomes that the intervention should be designed to achieve, and balancing the resource implications of intervention development and delivery against the purported benefits of any intervention.More trials, adhering to CONSORT standards, and conducted in settings and populations underserved in this review, i.e. low- and middle-income countries and people with low literacy, would strengthen the results of this review and broaden its applicability. Assessing process measures, such as time taken to administer the intervention and researcher satisfaction, would inform the implementation of audio-visual consent materials.

Educational video while “waiting-to-be-seen” in a cardiology outpatient clinic promotes opt-in self-consent for biobanking of remnant clinical biospecimens: A randomized-controlled trial

“…Our results contrast with two Cochrane reviews that have recently covered or referenced the topic of AV media use when consenting for clinical studies [10,11]. While they concluded that little or no difference to consenting rates occurs from utilizing AV media, we must caution that most of the available evidence was of low to very low quality and rarely tested in randomized control trials where consenting rates were the primary outcome [8][9][10][11]14]. Many other studies in the literature are retrospective analyses, and most of them call for additional prospective trials like the one reported here [10,11].…”

Educational video while “waiting-to-be-seen” in a cardiology outpatient clinic promotes opt-in self-consent for biobanking of remnant clinical biospecimens: A randomized-controlled trial

“…Our results contrast with two Cochrane reviews that have recently covered or referenced the topic of AV media use when consenting for clinical studies [10,11]. While they concluded that little or no difference to consenting rates occurs from utilizing AV media, we must caution that most of the available evidence was of low to very low quality and rarely tested in randomized control trials where consenting rates were the primary outcome [8][9][10][11]14]. Many other studies in the literature are retrospective analyses, and most of them call for additional prospective trials like the one reported here [10,11].…”

Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability

“…This is consistent with findings from our earlier research using paper-based materials with this study population [38]. While high quality evidence is lacking about the impact of audio-visual interventions on the consent process, some hypothesize that it may help individuals reduce anxiety associated with the experience [20]; this may be an indirect benefit associated with increased knowledge, greater appreciation and satisfaction with the information provided. The risk communication literature has shown that visual aids can help people comprehend quantitative efficacy and risk information, but not all visual aids are effective [50].…”

Comparison of Audiovisual and Paper-Based Materials for 1-Time Informed Consent for Research in Prison

“…Although understanding was slightly better with the audiovisual material in the adult prison, no statistically significant difference was found between audiovisual and paper-based material in the juvenile detention center. These results are in line with previous studies 14 , 15 that reported a small positive effect of video on understanding the IC. Of note, the study was not powered enough to detect small effect sizes in the juvenile detention center.…”

“…In the juvenile detention center, PLD were more likely to sign the IC after watching the video than after reading the paper-based material. Adult results were in line with previous findings reporting no effect of video vs paper-based material on acceptance to sign IC forms and enroll in studies in the general population . Adolescents spend more time on digital media than reading, which might explain why there was a preference for the audiovisual material in adolescents compared with adults.…”

Educational video while “waiting-to-be-seen” in a cardiology outpatient clinic promotes opt-in self-consent for biobanking of remnant clinical biospecimens: A randomized-controlled trial

“…Our results contrast with two Cochrane reviews that have recently covered or referenced the topic of AV media use when consenting for clinical studies [10,11]. While they concluded that little or no difference to consenting rates occurs from utilizing AV media, we must caution that most of the available evidence was of low to very low quality and rarely tested in randomized control trials where consenting rates were the primary outcome [8][9][10][11]14]. Many other studies in the literature are retrospective analyses, and most of them call for additional prospective trials like the one reported here [10,11].…”

Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability

“…This is consistent with findings from our earlier research using paper-based materials with this study population [38]. While high quality evidence is lacking about the impact of audio-visual interventions on the consent process, some hypothesize that it may help individuals reduce anxiety associated with the experience [20]; this may be an indirect benefit associated with increased knowledge, greater appreciation and satisfaction with the information provided. The risk communication literature has shown that visual aids can help people comprehend quantitative efficacy and risk information, but not all visual aids are effective [50].…”

Comparison of Audiovisual and Paper-Based Materials for 1-Time Informed Consent for Research in Prison

“…Although understanding was slightly better with the audiovisual material in the adult prison, no statistically significant difference was found between audiovisual and paper-based material in the juvenile detention center. These results are in line with previous studies 14 , 15 that reported a small positive effect of video on understanding the IC. Of note, the study was not powered enough to detect small effect sizes in the juvenile detention center.…”

“…In the juvenile detention center, PLD were more likely to sign the IC after watching the video than after reading the paper-based material. Adult results were in line with previous findings reporting no effect of video vs paper-based material on acceptance to sign IC forms and enroll in studies in the general population . Adolescents spend more time on digital media than reading, which might explain why there was a preference for the audiovisual material in adolescents compared with adults.…”

Educational video while “waiting-to-be-seen” in a cardiology outpatient clinic promotes opt-in self-consent for biobanking of remnant clinical biospecimens: A randomized-controlled trial

“…Our results contrast with two Cochrane reviews that have recently covered or referenced the topic of AV media use when consenting for clinical studies [10,11]. While they concluded that little or no difference to consenting rates occurs from utilizing AV media, we must caution that most of the available evidence was of low to very low quality and rarely tested in randomized control trials where consenting rates were the primary outcome [8][9][10][11]14]. Many other studies in the literature are retrospective analyses, and most of them call for additional prospective trials like the one reported here [10,11].…”

Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability

“…This is consistent with findings from our earlier research using paper-based materials with this study population [38]. While high quality evidence is lacking about the impact of audio-visual interventions on the consent process, some hypothesize that it may help individuals reduce anxiety associated with the experience [20]; this may be an indirect benefit associated with increased knowledge, greater appreciation and satisfaction with the information provided. The risk communication literature has shown that visual aids can help people comprehend quantitative efficacy and risk information, but not all visual aids are effective [50].…”

Comparison of Audiovisual and Paper-Based Materials for 1-Time Informed Consent for Research in Prison

“…Although understanding was slightly better with the audiovisual material in the adult prison, no statistically significant difference was found between audiovisual and paper-based material in the juvenile detention center. These results are in line with previous studies 14 , 15 that reported a small positive effect of video on understanding the IC. Of note, the study was not powered enough to detect small effect sizes in the juvenile detention center.…”

“…In the juvenile detention center, PLD were more likely to sign the IC after watching the video than after reading the paper-based material. Adult results were in line with previous findings reporting no effect of video vs paper-based material on acceptance to sign IC forms and enroll in studies in the general population . Adolescents spend more time on digital media than reading, which might explain why there was a preference for the audiovisual material in adolescents compared with adults.…”