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Table 1 Testing results of the original and revised versions of the participant information sheets

From: Performance-based readability testing of participant information for a Phase 3 IVF trial

  Rounds 1 & 2: Original sheets (n = 20)   Rounds 3 & 4: Revised sheets (n = 20)  
  Found (of which, found with difficulty) Understood Found (of which, found with difficulty) Understood
Nature and purpose of the trial     
Q1 Who is funding this trial? 20 (0) 20 20 (0) 20
Q2 What is the purpose of this trial? 20 (2) 18 20 (1) 17
Process and meaning of consent     
Q4 What would happen to any information collected from you as part of the trial? 20 (4) 17 20 (2) 18
Q6 How is it decided which participants receive which treatments in the trial? 20 (1) 20 20 (0) 19
Q11 Suppose you joined the trial and then decided to drop out. What do the sheets tell you about that? 20 (0) 20 20 (0) 20
Q12 What does it say about who might benefit from you taking part in this study? 20 (1) 20 20 (0) 18
Q14 Would you have to pay for any of the medicines used? 20 (0) 20 20 (0) 20
Q15 Suppose you are harmed by taking part in the trial. What does the sheet say about compensation? 20 (0) 14 20 (0) 18
Q19 What does the information sheet say about how the doctors identify which patients should take part in the trial? 20 (1) 19 17 (0) 17
Trial procedures     
Q3 If you took part in the study, would you have to make any additional visits to the hospital? 19 (1) 19 19 (0) 19
Q7 Suppose you took part in the trial and you needed to speak to a doctor urgently one evening. What number should you ring? 20 (1) 20 20 (0) 20
Q9 Suppose you took part in the trial and were in the Nafarelin short treatment group. When would you start to use the nasal spray? 20 (0) 20 20 (0) 19
Q10 What do the sheets say about taking Progesterone during the trial? 20 (0) 20 19 (1) 19
Q13 Suppose you are allocated to be in the Cetrorelix treatment group in the trial. What does it say about how and when Cetrorelix would be given to you? 20 (1) 15 20 (0) 19
Q16 Imagine you are in the Nafarelin long treatment group. How much time is there likely to be between starting the nafarelin and having a pregnancy test? 20 (0) 20 20 (0) 20
Q20 When taking part in the trial, on each occasion when you have taken your medicine, what would you then need to do? 20 (1) 20 20 (1) 20
Q21 Suppose you were taking part and had a concern about the study. How should you contact the doctors in charge? 20 (0) 20 20 (0) 20
Safety and efficacy of the medicine     
Q5 Please name the two drugs used in the trial that affect the pituitary or reproductive hormones. 20 (0) 20 20 (0) 19
Q8 What does the sheet tell you about Follicle Stimulating Hormone or FSH? 20 (0) 9 20 (2) 20
Q17 What does the information tell you about getting the side effects of hot flushes and night sweats? 20 (0) 19 20 (0) 20
Q18 How does the medicine Cetrorelix work on the body? 20 (0) 20 20 (1) 20
Total items NOT found (found with difficulty) 1(13)/420   5(8)/420  
Total items NOT understood   30/420   17/420