Table 5

Amendments to the protocol

DateChangeRationale
29 January 2021Removed ‘Life expectancy/ total survival’ from the list of outcomesAfter discussion within the team, we decided this outcome does not align well with the other included outcomes. The other outcomes give an indication of how well people self-manage their condition, whereas life expectancy/survival is a wider measure that gives less insight into self-management specifically. Moreover, there are unlikely to be many studies with sufficiently long follow-up to provide any meaningful assessment of survival in this context, and even if there was a study with very long follow-up, we would then be relying on an assumption that the patient activation exposures measured at baseline do not change over time.