Table 2 Statements where consensus was reached following rounds 1 and 2
‘Consensus in’: over 70% of respondents agreed with the following statements | |
Statement no. | Statement |
2 | Potentially serious harms need to be emphasised, even if they are very rare |
3 | Potential benefits and harms of a clinical trial need to be compared with what happens if the participant does not take part in the trial |
7 | The most likely potential benefits should be described |
8 | Any likely benefits to the participant (including embryos, foetus, nursing infants) should be described |
9 | General potential benefits (such as ‘the medicine may help you and your cancer’) should be described |
10 | Concrete, specific potential benefits (such as ‘this medicine is designed to enable you to walk farther before becoming breathless’) should be described |
15 | The harms should be separated into serious (life-threatening, causing permanent damage) and less serious (like a mild headache that goes away quickly) |
16 | Not all potential harms are known, especially for new treatments that have not been studied extensively. Participants need to know that not all potential harms can be listed |
17 | Sometimes harms are discovered after the trial begins. As soon as they are discovered, participants need to be told about them |
18 | Risks to conceiving/fathering a child, pregnancy or breastfeeding should be emphasised |
21 | Potential trial harms should be described in such a way that they can be compared to what would happen if the participant did not take part in the trial |
‘Consensus out’: over 70% of respondents disagreed with the following statements | |
Statement no. | Statement |
5 | Benefits are never completely certain, so they should not be described |
6 | Potential benefits should be described more fully than potential harms |
12 | Participants should not be told about potential harms |
14 | Only the most common possible harms should be mentioned. This will focus the reader’s attention and minimise overload |
24 | Information about potential benefits or harms should be presented apart by one or more pages |