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Published byMaximilian Wilkinson Modified over 9 years ago
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THE ADEPT STUDY ADEPT DATA FORMS The user’s view Dr Alison Leaf Southmead Hospital, Bristol
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Consent Form Clear and easy to use Fathers can only sign if married to baby’s mother Ensure use ball point pen to get writing through the 4 layers Ensure parent initials box, rather than ticks Give top copy to parents
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Entry form Must have items 1-9 before randomisation This is good opportunity to get to know your obstetricians! Randomisation programme prints out allocation Doppler info is most detailed – best to try and collect all info before mum discharged
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Daily feed log Most important data Ensure all staff know when and how to complete – and do every day ? Insert weight only when re-weighed Only total volumes of enteral / IV fluid Measures of feed intolerance: no need to tick box, insert letter from key to explain
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Discharge / transfer form Contact details important for follow-up Complete data for all diagnoses/treatments in your hospital For NEC, sepsis, cholestasis, days of IC/HD care – refer to definitions in protocol and Handbook For transfers give full contact details of new hospital
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NEC / Abdominal Pathology Best to start this at time diagnosis is first considered and up-date as process evolves Final diagnosis – at top but ?complete last - ensure consultant agrees with diagnosis listed! Modified Bell’s Criteria – on back of form, in protocol and in Handbook ? Stage 1A may be under-reported
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36-week form Simple to complete Provides growth data to calculate z-scores Provides data on BPD @36 weeks Reminds you that baby is in ADEPT if discharge or transfer is imminent!
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SAE / SUSAR Important to do if unexpected event occurs Must be submitted within 48 hours SAE = serious adverse event Death, tamponade, CV-line complication SUSAR = suspected unexpected serious adverse reaction If in doubt contact ADEPT office
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General points Multi-page forms - ensure stay together; ?staple 28-day log at top Write in black biro - ensure writing goes through all pages; blue does not photocopy well Complete as soon as possible, keep a copy, send to Mary - FREEPOST envelopes!
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