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Table 3 shows the answers of the evaluation of the patient informed consent by patients undergoing radiotherapy and randomly selected males not undergoing radiotherapy (non-patients)

From: Feasibility, pitfalls and results of a structured concept-development phase for a randomized controlled phase III trial on radiotherapy in primary prostate cancer patients

  In total Fully agree (1) Partially Agree (2) Neutral (3) Partially disagree (4) Fully disagree No answer
The PIC …   Patients Non-Patients Patients Non-Patients Patients Non-Patients Patients Non-Patients Patients Non-Patients Patients Non-Patients
is comprehensible 10 60% 50% 40% 40% 0% 10% 0% 0% 0% 0% 0% 0%
answers all relevant questions 10 80% 50% 10% 50% 10% 0% 0% 0% 0% 0% 0% 0%
is clearly structuered 10 70% 80% 30% 10% 0% 10% 0% 0% 0% 0% 0% 0%
explains the medical/therapeutic benefit of the trial 10 70% 80% 30% W20% 0% 0% 0% 0% 0% 0% 0% 0%
explains the trial’s procedure 10 90% 70% 10% 20% 0% 10% 0% 0% 0% 0% 0% 0%
explains personal benefits of participating in the trial 10 80% 60% 20% 40% 0% 0% 0% 0% 0% 0% 0% 0%
explains personal risks of participating in the trial 10 90% 40% 10% 60% 0% 0% 0% 0% 0% 0% 0% 0%
explains treatment alternatives if the patient chooses not to participate in the trial 10 70% 40% 10% 50% 0% 0% 10% 0% 10% 10% 0% 0%
explains the legal rights of paticipating in the trial 10 80% 70% 10% 20% 0% 10% 0% 0% 0% 0% 10% 0%
contains comprehensive figures 10 60% 70% 40% 30% 0% 0% 0% 0% 0% 0% 0% 0%
containts figures, which support the presented information 10 50% 80% 50% 20% 0% 0% 0% 0% 0% 0% 0% 0%
leaves the patient without open questions 10 70% 70% 30% 10% 0% 20% 0% 0% 0% 0% 0% 0%