Nature and purpose of the trial |
|
|
|
|
Q4 What sort of patient is being offered 'non-intensive' treatment? |
45 |
45 |
58 |
58 |
Q14 What is this trial trying to find out? |
24 |
18 |
54 |
49 |
Q15 How will it be decided which patients in the trial receive which treatment? |
52 |
52 |
61 |
61 |
Q20 A patient could get 1 of 4 different treatments within the trial. What are the 4 different treatments? |
55 |
52 |
60 |
59 |
Process and meaning of consent |
|
|
|
|
Q2 Suppose you decided to take part in the trial but later changed your mind. Would you have to give a reason? |
55 |
55 |
59 |
59 |
Q8 Suppose you take part and are harmed by the trial. What can you do? |
54 |
54 |
60 |
60 |
Q16 What happens to the information collected about you as part of the trial? |
55 |
54 |
61 |
60 |
Q17 Suppose you decide not to take part in the trial and receive the standard treatment. What medicines would you be given? |
37 |
36 |
58 |
58 |
Trial procedures |
|
|
|
|
Q1 If you need to contact the Haematology Unit at the hospital, what number should you use? |
49 |
47 |
61 |
61 |
Q3 Suppose you receive the drug Trisenox in the trial. How and when would it be given to you? |
55 |
55 |
61 |
61 |
Q7 What does the sheet say about the blood tests you would need to have if you took part in the trial? |
35 |
34 |
58 |
57 |
Q10 During the trial you may need to receive transfusions. Of what? |
55 |
54 |
61 |
61 |
Q12 When you receive any of the treatments in this trial, how far apart are the courses of treatment? |
54 |
53 |
61 |
61 |
Q21 If you don't take part in the trial and receive low dose Cytarabine as the 'standard treatment'. How is it given to you and how often? |
53 |
49 |
61 |
60 |
Safety and efficacy of the medicine |
|
|
|
|
Q5 What should you do to try to stop yourself getting a cold or infection while in this trial? |
53 |
52 |
60 |
60 |
Q6 Which parts of the body are most likely to be affected by side effects of the medicines in this trial? |
54 |
54 |
61 |
60 |
Q9 The medicine Mylotarg can cause jaundice. What does the information say about jaundice and what you should do? |
54 |
54 |
60 |
60 |
Q11 What does the sheet say about contraception while taking part in this trial? |
55 |
55 |
58 |
58 |
Q13 What does the information say about driving to and from the hospital for treatment? |
55 |
55 |
60 |
60 |
Q18 After each course of treatment the doctor may want to examine your bone marrow. Why? |
45 |
41 |
60 |
59 |
Q19 Imagine you are taking part in the trial and you get an infection. What should you do? |
52 |
51 |
60 |
60 |
Total items NOT found |
109/1155 |
|
28/1281 |
|
Total items found but NOT understood |
|
26 |
|
11 |