CESAR patients from trial entry to discharge Data collection and management – the roles of the Data Co-ordinating Centre (DCC) and hospital staff Steven Robertson, CESAR Trial Data Management Co-ordinator

 Map out various patient scenarios between trial entry and discharge  Explain the data collection procedures for different scenarios  Outline data collection roles and responsibilities

Patient is randomised Conventional ventilation ECMO Glenfield Hospital, Leicester Completed for every day patient is in intensive care DCC notified immediately when patient is transferred or dies Returned to DCC every 7 days by named nurse Patient dies Outcome page of organ support datasheet is returned to DCC No further organ support data required DCC contact consultant in charge to explain that the patient is in CESAR DCC contact ward regularly to check patient status Readmitte d to ICU Patient dies Patient transferred to another non ICU ward Patient is discharged Patient transferred to non ICU ward Level of care and organ support DCC send letter to patient about the follow-up visit DCC send letter to patient’s GP Patient agrees to follow up and a visit by one of the assessment researchers is arranged

 Data collection is the same whether patient receives ECMO or conventional management  Named nurses are responsible for the collection and return of data while the patient is in ICU  Non ICU outcome data is collected by staff and consultants on these wards  In exceptional circumstances we may seek help of named nurse if the hospital is an online CESAR centre

Steven Robertson Tel: Fax: