Table 1 Core concepts identified for inclusion in the recruitment appointments

• Consultation purpose

• Relevant history, diagnosis and/or management to date

• Current management options (independent of study)

• Clinical Equipoise regarding trial treatments

• Research study purpose or question

• Trial arm 1 processes, disadvantages/risks, advantages/benefits

• Trial arm 2 processes, disadvantages/risks, advantages/benefits

• (3 arm trial only) Trial arm 3 processes, disadvantages/risks, advantages/benefits

• Reason for trial or trial purpose

• Randomisation

 ◦ Reason for randomisation

 ◦ Process of randomisation

• Detail on trial treatment options

 ◦ Processes, potential risks and benefit

• Detail on trial procedures

 ◦ Potential risks/costs/burden & benefits of taking part,

 ◦ Options to refuse or withdraw,

 ◦ Options for further support in decision making about participation,

 ◦ Benefits to professional or organisation of P taking part.

 ◦ Confidentiality of data

 ◦ Explanation re compensation arrangements