Feasibility data outcomes included the success of screening and recruitment strategies; data collection and entry processes; confirmation of Research Nurse time and cost, and produced further estimates of ventilation times and medication dosing, which can be used to finalise sample size requirements for the larger trial, and inform funding applications for same.
Only mothers that had full set of records were included in the study, which finalised the sample of 5,125 mother-children dyads.
Although we have had many indications of willingness to participate in such a trial, we are unable to finalise the sample size calculations without reliable data of the spectrum of disease severity which clinicians are prepared to recruit.
Risk-adjusted p charts lack the power to detect small changes in performance, do not accumulate evidence over time, are vulnerable to the effects of multiple testing, and have an obligate delay to finalise a sample period (that is, a month of data) before an alert can be recognised, irrespective of the magnitude of the difference between observed and predicted outcomes.
It was decided to finalise the sampling strategy following a three-week pilot phase, during which all consenting callers would be included.
CF co-ordinated the study, arranged sample acquisition, revised and finalised the manuscript.
The content of the questionnaire was discussed with the Society's Review Board and with a panel of pediatricians, and finalised after a pilot test in a sample of 10 pediatricians.
The study is exploratory in its current form and specific plans to use the bio-repository samples are expected to be finalised at a later date.
A final version of the scale was agreed and analyses re-run using the online survey data and data from an independent sample to report the psychometric properties of the finalised scale.
Using a random sample of included studies, the initial categories were tested, revised as necessary, and then finalised by the two reviewers (LL and SK).
