Assessing capacity | Evidence that the individual had been given information relevant to the trial and their understanding was assessed directly by the trial team | 2 |
Researchers applied an instrument to measure the level of cognitive impairment (eg, mini-mental state examination) to each individual and based their assessment of capacity to consent on this | 1 |
A carer (eg, nursing home staff and general practitioner) was shown the study information sheet and asked to give an opinion whether the individual would be able to understand the information in order to give informed consent | 1 |
Researchers based their consent process on the level of cognitive impairment as perceived by the carers without specific reference to the information needed to understand the trial | 0 |
Use of proxies | For participants who were deemed to lack capacity, consent/agreement was obtained from next of kin/legal representative/carer | 1 |
Consent/agreement was not obtained from next of kin/legal representative/carer | 0 |
Assent procedure (if consent was obtained via proxy) | Verbal assent was obtained from the participants when receiving the intervention treatment or at the time of data collection ORIf neither treatment nor data collection involved the participant directly (eg, data collected from medical records), assent was not required | 1 |
No assent was obtained | 0 |