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Data Collection, Analysis Plan, Role of DMEC

Data Collection, Analysis Plan, Role of DMEC. Elizabeth Allen Diana Elbourne. Data collection. Two main drivers: Collect everything that’s needed to answer trial Qs Collect only what’s needed to answer trial Qs In the most efficient ways As little work as possible for busy clinicians.

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Data Collection, Analysis Plan, Role of DMEC

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

  2. Data collection • Two main drivers: • Collect everything that’s needed to answer trial Qs • 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. 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

  5. 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!

  6. 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

  7. 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

  8. 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

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

  10. 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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