Study | Country | Design | Target clinical group | Population | Sample size | Intervention | Comparator | Outcome | Method outcome assessment | |
---|---|---|---|---|---|---|---|---|---|---|
Type | Mode | |||||||||
Afolabi-2015 [39] | Gambia | Clinical Trial | Malaria | Adults with asymptomatic malaria, < 50 years, more than 50% women with no formal education | 311 | Video | In person | Paper consent | Comprehension | Comprehension questionnaire administered using laptop computers by trained interviewers who entered participants’ responses to each question |
Barrera-2016 [40] | Worldwide | Observational | Pregnant women | Pregnant women, mean age 27.6 years, 81.5% university level education | 1179 | Online informed consent | In person | None | Comprehension | Four multiple-choice items |
Ditai-2018 [41] | Uganda | Observational | Pregnant women | Pregnant women, no mean age reported, 50% with no formal education | 30 | Slide show using illustrated text on a flip chart or video | In person | Standard researcher read IC | Comprehension and recalling | Modified Quality of Informed Consent form (QuIC) and semi-structured interview |
Haussen-2017 [42] | United States | Observational | Stroke | Adults, mean age 73 years | 4 | DAWN trial: All 3 components of IC electronic. ARISE-II method presumed the same | Remote | Paper consent | Description of first experience with electronic consent | Research Electronic Data Capture |
Mattock-2020 [43] | United Kingdom | Clinical Trial | Behavioural problems in young children | Parents mean age 33.59 years, 93% biological mothers, 47% educated to postgraduate level. Mean child age 21.9 months | 107 | Video as an aid to paper consent | Remote | Paper consent | Recruitment rate | Number of subjects consented in main trial and brief structured interviews |
Rothwell-2014 [44] | United States | Clinical Trial | Women, prenatal education | Female participants, 61% had given birth before, 41.94% were educated at a bachelor’s degree | 62 | Video on iPad as an aid to paper consent | In person | Paper consent | Comprehension | 14-item survey and telephone interview |
Bobb-2016 [45] | United States | Clinical Trial | Pneumonia | Adults, mean age 55, 49% subjects were male | 131 | Telemedicine as an aid to paper consent | In person | Paper consent | Comprehension | Quality of informed consent (QuIC) instrument |
Dobscha-2005 [46] | United States | Observational | Depression | Adults, 87–93% male. Mean age varied from 57 to 59 | 31 | Videoconferencing—all 3 components electronic | Remote | Paper consent | Description of first experience with electronic consent—Patient satisfaction | 12-item mail survey |
Dobscha-2005 [46] | United States | Observational | Depression | Adults, 87–93% male. Mean age varied from 57 to 59 | 31 | Videoconferencing—all 3 components electronic | Remote | Paper consent | Description of first experience with electronic consent—Patient satisfaction | 12-item mail survey |
Jolly-2019 [47] | United Kingdom | Clinical Trial | COPD | Adults, mostly male, mean age 70 years, limited educational qualifications | 4214 | Standard printed materials with access to a multimedia information resource | Remote | Paper consent | Recruitment rate | Number of patients recruited to host trial and responding invitation |
Lurie-2011 [48] | United States | Observational | Spine Surgery | Adults with IDH or SPS—with or without DS. IDH mean age 41.2–42 years, SPS mean age 65.1–67.1 years, IDH female gender 38–46%, SPS female gender 42–52%) | 2505 | Video decision aid as part of their informed consent process | In person | Before and after viewing video | Changes in treatment preference | Answer to question “What is your current preference for how to treat your spine-related problem?” on a 5-point scale |
Swain-2017 [49] | United States | Observational | Breast cancer | Adults with breast cancer, mean age 59 years, 29% attended college or technical school | 200 | Video | In person | None | Recruitment rate | Patients who signed consent regardless they enrolled in a trial. AIET questionnaire |
Weston-1997 [50] | Canada | Clinical Trial | Pregnant women | Pregnant women, median maternal age 31.4–31.8 years, median gestation in weeks 25–27.3, 40–42% college degree or higher | 90 | Video | In person | Paper consent | Willigness for future participation in a trial |