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Data Collection, Analysis Plan, Role of DMEC Elizabeth Allen Diana Elbourne.

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Presentation on theme: "Data Collection, Analysis Plan, Role of DMEC Elizabeth Allen Diana Elbourne."— Presentation transcript:

1 Data Collection, Analysis Plan, Role of DMEC Elizabeth Allen Diana Elbourne

2 Data collection Two main drivers: 1.Collect everything that’s needed to answer trial Qs 2.Collect only what’s needed to answer trial Qs In the most efficient ways As little work as possible for busy clinicians

3 Everything that’s needed In order to collect what’s needed, first write the outline of the trial results (tables/figures) but minus the data! –‘Dummy’ tables/figures (several drafts) Agreed by –trial project management group (PMG), steering committe (TSC) and Data Monitoring and Ethics Committee (DMEC) Used as a basis for agreeing appropriate data collection

4 Random Allocation Tight control N= Conventional treatment N= * Centre Sex Male (n) Age * 0 - <1 (n) 1 - < 16 (n) median (IQR)

5 Only what's needed Always tempting to ask for just a little more and just a little more and ….. But “more is less” / “less is more” –Asking for more often means getting less and/or poorer quality –Asking for less means surer of getting it and getting good quality

6 Most efficient collection Use existing data collection systems as much as possible –eg PICANET (with appropriate data protection safeguards) Use methods that work well in other trials –eg little and often (small amounts of information collected often (eg daily) rather than all at the end (eg at 30 days) –Important for keeping track of patients who move!

7 Data processing Team at LSHTM (Koro Diallo, Deborah Piercy, Nicola Wilson-Smith) –Track data especially hospital transfers and follow up –Double data entry and resolve discrepancies –Prepare data for statistician Working closely with Helen and research nurses

8 Statistical analysis Analyse all data in groups as randomised –Reduces biases (‘intention to treat’) Describe characteristics of patients at baseline –and check that randomisation has worked in generating comparable groups Describe actual management (compliance) Outcomes –Primary and secondary Stratify by cardiac and non-cardiac cases

9 DMEC (1) DMEC is the only group to look at the accumulating unblinded data –Except trial statistician who prepares report Main responsibilities –to check safety of patients, both already in the trial and future patients to be entered –to check trial question still important for future patients, and answerable but not already answered Recommendations to TSC to carry on, amend or suspend/stop

10 DMEC (2) Members David Dunger David Harrison David Hatch Giles Peek Spot the odd man out!

11 Concluding remarks CHiP can only provide answers for future patients if high quality data collected, processed, analysed and reported All members of CHiP team (in PICUs and centrally) play complementary roles


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