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

Outcome page of organ support datasheet is returned to DCCNo further organ support data required

DCC contact consultant in charge to explain that the patient is in CESARDCC contact ward regularly to check patient status

Readmitted to ICU

Patient dies

Patient transferred to another non ICU

ward

Patient isdischarged

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: 020 7927 2075

Fax: 020 7637 2853Email: steve.robertson@lshtm.ac.uk