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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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Data collection analysis plan role of dmec l.jpg

Data Collection, Analysis Plan, Role of DMEC

Elizabeth Allen

Diana Elbourne


Data collection l.jpg

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


Everything that s needed l.jpg

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


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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


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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!


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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


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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


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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


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DMEC (2)

Members

David Dunger

David Harrison

David Hatch

Giles Peek

Spot the odd man out!


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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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