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
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1. Information search
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10 items
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Measured before consent to participate in trial
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I understand the option, of participating in the trial or not, is available to me
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2. Knowledge gain
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3. Appraisal of knowledge sufficiency
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4. Imagining counterfactuals
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I know how I feel about participating in the trial or not
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5. Affective forecasting
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6. Preference construction
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Quality of Informed Consent (QuIC) [6]
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2001
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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
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1. Objective understanding (part A)
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Total = 34 items
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After consent
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I have been informed how long my participation in this clinical trial is likely to last (part A)
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Part A: Objective understanding (n = 20)
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2. Subjective understanding (part B)
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Based on 13 domains identified in regulatory documents on informed consent
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Part B: Subjective understanding (n = 14)
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The fact that your treatment involves research (part B)
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Informed Consent Assessment Instrument (ICAI) [9]
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2013
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Set within an open-drug RCT for tuberculosis
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No explicit theory reported
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Content informed by the four principles of research ethics: autonomy, beneficence nonmaleficence and justice
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Total = 10 items
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Measured right after time of consent, then remeasured 8 to 10 weeks after consent
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Are you participating in a clinical trial?
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Authors state informed by principles of research ethics
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Are the risks and benefits of taking part in the study clear?
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Format informed by QuIC
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Brief Informed Consent Evaluation protocol (BICEP) [10]
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2005
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Set within eight different parent RCTs
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No explicit theory reported; conceptual dimensions: therapeutic misunderstanding, voluntariness and understanding
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Autonomous authorisation
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Total = 15 items
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Measured immediately after consent process
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What is the primary purpose of [parent study]?
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Informed consent aggregate score (ICAS) (n = 10)
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What are the benefits to you of participating in the [parent study]?
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Therapeutic misconception aggregate score (TMAS) (n = 5)
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