PRO endpoints: 2°

‘If, when reviewing the completed EQ-5D-5L questionnaire, the research nurse becomes concerned for the well-being of the participant, they should discuss their concerns with the participant directly, working in partnership to determine the best course of action. With the participant’s permission, the research nurse may need to consult with the PI and/or treating clinician to address these concerns. In exceptional circumstances, the research nurse may consult with the PI and/or treating clinician without the permission of the participant if they are concerned for the participant’s safety’.

‘If the study research nurse becomes concerned for your well-being during a study review, they will discuss their concerns with you, to determine the best course of action. With your permission, the research nurse may need to consult with a senior member of the study and/or your treating clinician to address these concerns. In exceptional circumstances, the research nurse may need to do this without your prior permission if they are concerned for your safety’.

‘I understand that if the study research nurse becomes concerned for my well-being during a study review, they will discuss their concerns with me to determine the best course of action. With my permission, the research nurse may need to consult with a senior member of the study and/or my treating clinician to address these concerns. In exceptional circumstances, the research nurse may need to do this without my prior permission if they are concerned for my safety.’¹¹⁴