Skip to main content

Table 1 Summary of the main characteristics

From: Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials

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