Table 6 Comparison of DelibeRATE tool with existing measures of informed consent ^a

DelibeRATE

2012

Set within three different parent RCTs: two surgical and one drug, all phase III pragmatic RCTs of direct head-to-head comparisons

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

Conceptual framework considered: existing theoretical work on therapeutic misconception, regulations governing research, recommendations of National Cancer Institute working group

1. Objective understanding (part A)

Total = 34 items

After consent

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

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)