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Table 3 Percentage of participants by QuIC Part B score: a subjective understanding of J-START

From: Participants’ understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START

   QuIC questions QuIC scores No
    1 2 3 4 5 reply
B1. Nature of research This breast cancer screening involves a research component 1.1 2.1 3.7 39.6 51.6 1.9
B2. Purpose of research What the researchers are trying to understand in J-START 0.3 1.1 1.6 36.7 59.0 1.3
B3. Duration of procedures How long you will be in J-START 1.9 7.2 9.0 33.8 46.8 1.3
B4. Procedures to be followed The tests and procedures you will undergo 1.1 0.8 2.7 30.6 62.2 2.7
B5. Experimental nature of study Which of these tests and procedures are experimental 1.1 4.3 7.5 38.6 39.4 9.3
B6. Potential risks or discomforts The potential risks or discomforts associated with participating in J-START 1.9 4.5 13.8 34.8 43.4 1.6
B7. Benefits to self The potential benefit to you for participating in J-START 2.1 1.9 14.4 42.0 37.8 1.9
B8. Benefits to others How your participation in this clinical trial might benefit future patients 0.3 0.3 2.4 31.4 64.1 1.6
B9. Alternatives to participation The alternative to participation in the clinical trial 0.8 1.3 6.4 28.5 61.4 1.6
B10. Confidentiality The effect of clinical trial participation on the confidentiality of your medical records 0.5 0.0 3.2 30.1 64.9 1.3
B11. Compensation Who will pay for treatment if you are injured or become ill due to participation in J-START 14.9 19.4 18.4 21.8 22.9 2.7
B12. Study contacts Whom you should contact if you have questions or concerns regarding J-START 4.5 6.4 11.7 31.9 43.9 1.6
B13. Voluntary nature of participation The fact that participation in J-START is voluntary 0.5 0.3 0.3 17.8 79.8 1.3
B14. Overall Overall, how well did you understand your specified clinical trial when you signed the consent form? 0.8 2.4 4.5 65.7 25.3 1.3
  1. Quality of Informed Consent (QuIC) is a scale for assessing participants’ understanding of clinical trial procedures. Part A assesses objective understanding and Part B assesses subjective understanding [6]. QuIC Part B responses were as follows: 1 for “did not understand”, 2 for “almost did not understand”, 3 for “neither understood nor didn’t understand”, 4 for “generally understood”, and 5 for “understood very well”. J-START, Japan STrategic Anti-cancer Randomized controlled Trial.