Table 2.

Examples from training materials for recruiters to the MACRO trial (informed by training materials for recruitment to trials developed by the QuinteT Team [19])

The MACRO Guidance for recruiters was structured under the following headings: ‘Starting the appointment’, ‘Explaining the study design’, ‘Explaining timing for the study and follow up’ and ‘Closing the appointment’.

Two examples from the training notes are given below.

‘Explaining the study design’: examples of guidance

• ‘Ask patients to keep an open mind until you have presented all the information

• Present balanced information about all treatment options. It is best to call the arms ‘treatment option 1’, ‘treatment option 2’ and ‘treatment option 3’. Try to avoid the use of standard or experimental treatment

• When explaining the study design, you may find it useful to draw the treatment options on a piece of paper or use a simple pre-prepared diagram like that found in the MACRO Patient Information Sheet (training materials replicate suitable diagram here).

•Gently explore any patient preferences to uncover and challenge any misunderstandings’

Explaining treatment allocation/randomisation: examples of guidance

• ‘Explain to patients that they will be allocated to a treatment option by a process called randomisation

• Explain that they will have an equal chance of receiving each of the three treatment options, but neither the patient nor the doctor can choose the treatment option

• Explain that randomisation is used to ensure the groups can be compared fairly by making sure that each group is similar-

• Avoid using terms such a ‘toss of a coin’ or ‘decided by computer’. You may want to say something like this:

‘If you agree to take part in the MACRO study you will be allocated to one of three treatment options through a process called randomisation. This means that you will be assigned to one of the options by chance and neither you nor your doctor can choose. This is so that the options can be compared fairly-each group will contain similar numbers and be similar in all other ways. You will have an equal chance of getting each of the treatment options.’