RT Journal Article
SR Electronic
T1 Sequential co-enrolment in randomised trials in neonatal intensive care medicine
JF Archives of Disease in Childhood - Fetal and Neonatal Edition
JO Arch Dis Child Fetal Neonatal Ed
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP 128
OP 131
DO 10.1136/archdischild-2019-316818
VO 105
IS 2
A1 Whitney Yoder
A1 Floris Groenendaal
A1 Wes Onland
A1 Anna van Oploo
A1 Charlotte Rietbergen
A1 Rolf Groenwold
YR 2020
UL http://fn.bmj.com/content/105/2/128.abstract
AB In many medical research settings, such as the neonatal intensive care unit, the number of patients who are eligible for a randomised clinical trial is relatively small and recruiting a sufficient number of patients into trials is often difficult. Furthermore, some infants may have already been enrolled into a trial as a fetus. Sequential co-enrolment of patients into more than one trial may offer a solution, yet runs the risk of contaminated results. We consider the situation of two sequential trials and describe requirements for different possible treatments effects (‘estimands’) to be estimated in such situations. These estimands differ regarding the extent to which participation status and treatment status in the previous trial is accounted for. Because of differences in available information about previous trials, analyses may result in estimated effects which differ in terms of interpretation and generalisability, except when in the absence of an interaction between the studied treatments. If co-enrolment cannot be ruled out, researchers should collect information about co-enrolment and treatment status in a previous or concurrent trial and mitigate the trial analysis plan in order to estimate meaningful effects.