Table 1.
Information finding and understanding results from the trial phase
| Original version (n = 55) | Revised version (n = 61) | |||
|---|---|---|---|---|
| Found | If found, understood | Found | If found, understood | |
| 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 | ||