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Table 2 Percentage of participants by QuIC Part A score: an objective 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 items QuIC scores No
1 2 3 reply
A1. Nature of research When I signed the consent form for J-START, I knew that I was agreeing to participate in a clinical trial 0.3 5.6 92.6* 1.6
A2. Purpose of research The main goal of J-START is improving breast cancer screening for future generations 0.0 2.7 95.7* 1.6
A3. Duration of procedures I have been informed about the duration of J-START 4.8 30.3 63.3* 1.6
A4. Experimental nature of study All tests in J-START are standardized 14.6* 26.1 57.5 1.9
A5. Purpose of research The major purpose of J-START is to assess the effectiveness of ultrasound screening for breast cancer among Japanese women aged 40–49 years 1.1 10.6 86.7* 1.6
A6. Purpose of research Neither the mammography screening nor the combined use of mammography and ultrasound screening have been proven as the best screening method for Japanese women aged 40–49 years 0.8 25.3 72.3* 1.6
A7. Procedures to be followed After I agreed to participate in J-START, my examination was chosen randomly between mammography screening or combined use of mammography and ultrasound screening 1.9 11.4 85.1* 1.6
A8. Potential risks or discomforts Compared with standard breast cancer screening, J-START does not carry any additional risks or discomforts 14.1* 35.6 48.7 1.6
A9. Benefits to self I might not receive any direct medical benefits from my participation in J-START 25.5 38.3 34.6* 1.6
A10. Benefits to others By participating in J-START, I am helping the researchers gather information that might benefit future breast cancer screening procedures 0.3 10.4 87.8* 1.6
A11. Confidentiality Because I am participating in a clinical trial, it is possible that the study sponsor, various government agencies, or others who are not directly involved in my care will review my medical records 3.7 33.2 61.4* 1.6
A12. Alternatives to participation My doctors did not offer me any alternative breast cancer screening procedures beyond J-START. 87.8* 9.3 1.3 1.6
A13. Compensation The consent form I signed indicates who will pay for treatment if I am injured or become ill as a result of participation in this clinical trial 14.9 50.3 33.0* 1.9
A14. Study contacts The informed consent form listed study contact persons 4.8 19.7 73.7* 1.9
A15. Voluntary nature of participation If I had not wanted to participate in this clinical trial, I could have declined to sign the consent form 1.1 11.4 85.6* 1.9
A16. Voluntary nature of participation I must remain in the clinical trial, even if I decide that I would like to withdraw someday 60.1* 30.1 8.2 1.6
  1. Quality of Informed Consent (QuIC) is a scale for assessing participants’ understanding of clinical trials. Part A assesses objective understanding and Part B assesses subjective understanding. QuIC Part A possible responses are 1 (quite disagree), 2 (unsure) and 3 (totally agree) [6]. *Correct answer. J-START, Japan STrategic Anti-cancer Randomized controlled Trial.