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

From: Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials

Instrument Year Population Theoretical/conceptual framework Constructs assessed Items Timing Sample questions
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)
  1. aRCT, Randomised controlled trial.