b) Transport form (a) at trial entry – completed by Glenfield Hospital transport team to record transfer of trial participants to ECMO centre or conventional treatment centres.
Common reasons for a delayed trial entry included awaiting trial cohorts to open (n = 31; 44%), waiting for trial work-up (n = 18; 26%), needing time to consider (n = 10; 14%), being on another treatment (n = 8; 11%) and patient preference (n = 8; 11%).
Practitioners commented on how parents were highly variable in their willingness to engage in a recruitment discussion and make a decision about trial entry when children are critically ill.
The eligibility criteria were integrated into the quitline clinical information system such that counsellors were prompted to complete a template recording an offer of trial entry to all callers that met the three criteria.
Cases were all participants who did not have a tumour at trial entry, but who subsequently developed Kaposi's sarcoma (n=189) or non-Hodgkin's lymphoma (n=67).
A delay in trial entry was arbitrarily defined as greater than 1 month from the date of the initial clinic visit to the date of starting study drug(s).
Seventy of 197 patients (35.5%) experienced a delay in entering a trial, with a median time to trial entry of 7.1 weeks.
In addition, a post hoc Poisson regression was conducted for the primary outcome adjusting for gestation at birth, whether the mother had an anticonvulsant before trial entry, PNM in country, route of maintenance therapy, sex of the baby, multiple pregnancy and whether admitted to a special care baby unit.
In our sample, patients who reported a high level of symptoms at trial entry had a poor prognosis, but tended to report better outcomes over time (either through concomitant care, habituation or statistical regression to the mean).
This was a greater concern than trial entry itself.
