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DelibeRATE
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2012
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Set within three different parent RCTs: two surgical and one drug, all phase III pragmatic RCTs of direct head-to-head comparisons
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Structured around a conceptual framework informed by theories of decision-making which separates decision-making process into deliberation and determination
|
1. Information search
|
10 items
|
Measured before consent to participate in trial
|
I understand the option, of participating in the trial or not, is available to me
|
|
2. Knowledge gain
|
|
3. Appraisal of knowledge sufficiency
|
|
4. Imagining counterfactuals
|
|
I know how I feel about participating in the trial or not
|
|
5. Affective forecasting
|
|
6. Preference construction
|
|
Quality of Informed Consent (QuIC) [6]
|
2001
|
Patients and parents of paediatric patients enrolled in phase I, II or III clinical trial; tool developed with intention to be used across clinical areas
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Conceptual framework considered: existing theoretical work on therapeutic misconception, regulations governing research, recommendations of National Cancer Institute working group
|
1. Objective understanding (part A)
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Total = 34 items
|
After consent
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I have been informed how long my participation in this clinical trial is likely to last (part A)
|
|
Part A: Objective understanding (n = 20)
|
|
2. Subjective understanding (part B)
|
|
Based on 13 domains identified in regulatory documents on informed consent
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Part B: Subjective understanding (n = 14)
|
|
The fact that your treatment involves research (part B)
|
|
Informed Consent Assessment Instrument (ICAI) [9]
|
2013
|
Set within an open-drug RCT for tuberculosis
|
No explicit theory reported
|
Content informed by the four principles of research ethics: autonomy, beneficence nonmaleficence and justice
|
Total = 10 items
|
Measured right after time of consent, then remeasured 8 to 10 weeks after consent
|
Are you participating in a clinical trial?
|
|
Authors state informed by principles of research ethics
|
|
Are the risks and benefits of taking part in the study clear?
|
|
Format informed by QuIC
|
|
Brief Informed Consent Evaluation protocol (BICEP) [10]
|
2005
|
Set within eight different parent RCTs
|
No explicit theory reported; conceptual dimensions: therapeutic misunderstanding, voluntariness and understanding
|
Autonomous authorisation
|
Total = 15 items
|
Measured immediately after consent process
|
What is the primary purpose of [parent study]?
|
|
Informed consent aggregate score (ICAS) (n = 10)
|
|
What are the benefits to you of participating in the [parent study]?
|
|
Therapeutic misconception aggregate score (TMAS) (n = 5)
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