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Table 1 Information finding and understanding results from the trial phase

From: Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

  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