Table 4 Recommended core set of site performance metrics (n = 8) retained following the consensus meeting
Domain | Metric: original wording | Definition: original wording | Metric: amended wording | Definition: amended wording |
|---|---|---|---|---|
Recruitment and retention | 1. Total actual recruitment versus total target recruitment (%) | The actual number of participants recruited into the trial by the site, versus the target number that was contractually agreed with the site prior to the trial commencing | Current actual recruitment versus target recruitment (%) | The actual number of participants recruited into the trial by the site, at the time of monitoring, versus the target number that was contractually agreed with the site prior to the trial commencing |
7. Percentage of potential participants eligible who have consented | The percentage of potential participants who were eligible to participate in the trial and who consented to participate | Percentage of eligible individuals who have consented | The percentage of individuals who were eligible to participate in the trial and who consented to participate | |
9. Percentage of randomised participants who have withdrawn consent to continue | The percentage of randomised participants who have withdrawn their consent to any further participation in the trial at the site. Collection of any further follow up data is therefore not attempted | |||
Data quality | 18. Percentage of randomised participants with a query for primary outcome data | The percentage of randomised participants at the site for whom the central trial team has sent one or more queries relating to the primary outcome data back to the site staff | ||
21. Percentage of randomised participants with complete data for primary and important secondary outcomes | The percentage of randomised participants at the site with outcome data complete for both the primary outcome and all the agreed important secondary outcomes | Percentage of expected participants with complete data for primary and important secondary outcomes | ||
26. Number of adverse events reported per number of randomised participants | Number of Adverse Events reported per number of randomised participants at the site | Percentage of randomised participants with at least one adverse event reported | The percentage of randomised participants at the site who have reported at least one adverse event | |
Protocol compliance | 27. Percentage of randomised participants with at least one protocol violation | The percentage of randomised participants at the site with any protocol violation/s, as defined by the protocol | ||
28. Percentage of randomised participants receiving allocated intervention as intended per protocol | The percentage of randomised participants at the site who started the allocated intervention, as specified in the protocol | Percentage of randomised participants who started allocated intervention |