Cochrane · systematic review · CD003717

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

Synnot, A, Ryan, R, Prictor, M, et al. · Cochrane Database of Systematic Reviews · 2014 · Cochrane Library

Consumers and CommunicationAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
23
current version
GRADE rated
13
No studies
10
Included studies
NR
No studies 10 · 43.5%Ungraded 0 · 0%Very low 4 · 17.4%Low 9 · 39.1%Moderate 0 · 0%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Summary of findings (Comparison 1)

Population: People with a health condition or nominally 'well' considering real clinical trial participation (across a range of topic areas)
9 questions
OutcomeEffectEvidenceStatus / GRADE
Knowledge (Single intervention) [mean number of correct questionnaire responses, assessed immediately post‐intervention]
no estimate extracted1 study · 155 participantsVery low
Downgraded: risk of bias, imprecision
Knowledge (Multi‐component intervention) [mean number of correct questionnaire responses, assessed immediately post‐intervention]
no estimate extracted1 study · 126 participantsVery low
Downgraded: risk of bias, imprecision
Satisfaction with the information provided (Single and multi‐component intervention)
no estimate extractedNRNo studies
Rate of participation (Single intervention)
no estimate extractedNRNo studies
Rate of participation (Multiple intervention) [questionnaire, measured immediately post‐intervention]
no estimate extracted1 study · 110 participantsVery low
Downgraded: risk of bias, imprecision
Anxiety, or other psychological distress (Single and multi‐component intervention)
no estimate extractedNRNo studies
Retention of knowledge (Single and multi‐component intervention)
no estimate extractedNRNo studies
Satisfaction with the decision‐making process (single intervention)
no estimate extractedNRNo studies
Satisfaction with the decision‐making process (multi‐component intervention) [questionnaire, assessed immediately post‐intervention]
no estimate extracted1 study · 126 participantsVery low
Downgraded: risk of bias, imprecision

Summary of findings (Comparison 2)

Population: people with a health condition (or pregnant) considering real clinical trial participation (across a range of topic areas)
7 questions
OutcomeEffectEvidenceStatus / GRADE
Knowledge ‐ continuous [mean number of correct questionnaire responses, measured immediately post‐intervention]
no estimate extracted2 studies · 143 participantsLow
Downgraded: imprecision, inconsistency
Knowledge ‐ dichotomous [> 80% of knowledge questions correct, measured immediately post‐intervention]
no estimate extracted2 studies · 290 participantsLow
Downgraded: imprecision, inconsistency
Satisfaction with the information provided
no estimate extractedNRNo studies
Rate of participation [case notes or questionnaire, measured immediately or up to four weeks post‐intervention]
no estimate extracted2 studies · 258 participantsLow
Downgraded: imprecision, inconsistency
Anxiety (or other psychological stress) [Spielberger State and Trait Anxiety score, measured immediately post‐intervention]
no estimate extracted1 study · 142 participantsLow
Downgraded: imprecision, inconsistency
Retention of knowledge [> 80% of knowledge questions correct, measured two to four weeks post‐intervention]
RR 1.38 [1.07, 1.77]1 study · 85 participantsLow
Downgraded: imprecision, inconsistency
Satisfaction with the decision‐making process
no estimate extractedNRNo studies

Summary of findings (Comparison 3)

Population: people with a health condition or nominally 'well' considering real or hypothetical clinical trial participation in cancer or psychiatric medication trials
7 questions
OutcomeEffectEvidenceStatus / GRADE
Knowledge [questionnaire (scored out of 80), measured immediately post‐intervention]
no estimate extracted1 study · 93 participantsLow
Downgraded: imprecision
Knowledge [scored correct answer to single question, measured immediately post‐intervention]
RR 1.17 [0.96, 1.43]1 study · 49 participantsLow
Downgraded: imprecision
Satisfaction with the information provided [single question, measured immediately post‐intervention]
RR 3.3 [1.24, 8.78]1 study · 44 participantsLow
Downgraded: imprecision
Rate of participation [case notes, measured immediately post‐intervention]
RR 0.41 [0.13, 1.33]1 study · 49 participantsLow
Downgraded: imprecision
Anxiety, or other psychological distress
no estimate extractedNRNo studies
Retention of knowledge
no estimate extractedNRNo studies
Satisfaction with the decision‐making process
no estimate extractedNRNo studies