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
| Â | Rounds 1 & 2: Original sheets (n = 20) | Â | Rounds 3 & 4: Revised sheets (n = 20) | Â |
|---|---|---|---|---|
| Â | Found (of which, found with difficulty) | Understood | Found (of which, found with difficulty) | Understood |
Nature and purpose of the trial | Â | Â | Â | Â |
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 | Â | Â | Â | Â |
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 | Â | Â | Â | Â |
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 | Â | Â | Â | Â |
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 | Â | 5(8)/420 | Â |
Total items NOT understood | Â | 30/420 | Â | 17/420 |