Recruitment
Item 14a - Dates defining the periods of recruitment and follow-up
Example
“Age-eligible participants were recruited … from February 1993 to September 1994 … Participants attended clinic visits at the time of randomisation (baseline) and at 6-month intervals for 3 years.”(199)
Explanation
Knowing when a study took place and over what period participants were recruited places the study in historical context. Medical and surgical therapies, including concurrent therapies, evolve continuously and may affect the routine care given to participants during a trial. Knowing the rate at which participants were recruited may also be useful, especially to other investigators.
The length of follow-up is not always a fixed period after randomisation. In many RCTs in which the outcome is time to an event, follow-up of all participants is ended on a specific date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200) (201)
A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearly 80% (104 of 132 reports) included the starting and ending dates for accrual of patients, but only 24% (32 of 132 reports) also reported the date on which follow-up ended.
Page last edited: 24 March 2010
