The SOFA score consists of weightings for six organ systems to give a total score ranging from 0 to 24,
with higher scores indicating a greater degree of organ failure.33The organ failure assessments are
as follows:
l respiratory dysfunction, based on lowest PaO2/FiO2
l cardiovascular dysfunction, based on vasopressor use and lowest mean arterial pressure
l renal dysfunction, based on highest creatinine
l neurological dysfunction, based on lowest (or last pre-sedation) GCS score
l hepatic dysfunction, based on highest bilirubin, and
l coagulation dysfunction, based on lowest platelet count.
The SOFA score was calculated from raw physiology and treatment data from the 24 hours prior to randomisation.
Appendix 4 Critical Care Minimum Dataset
Definitions
Duration of organ support in the critical care unit was defined as the number of days alive and free from support of each of the following organ systems, as defined by the UK Department of Health CCMDS
during the first 30 days following randomisation.36Patients who died within the first 30 days were
assigned zero days alive and free from organ support. Organ support definitions were as follows:
l Advanced respiratory– indicated by one or more of invasive mechanical ventilatory support through a
translaryngeal tube or tracheostomy; bilevel positive airway pressure through a translaryngeal tube or tracheostomy; continuous positive airway pressure through a translaryngeal tube; or extracorporeal respiratory support.
l Advanced cardiovascular– indicated by one or more of receipt of multiple intravenous and/or rhythm
controlling drugs (of which at least one must be vasoactive) when used simultaneously to support or control arterial pressure, cardiac output or organ/tissue perfusion; continuous observation of cardiac output and derived indices; an intra-aortic balloon pump or other assist device; or temporary cardiac pacemaker.
l Renal– indicated by receipt of acute renal replacement therapy (e.g. haemodialysis, hemofiltration,
etc.); or receipt of renal replacement therapy for chronic renal failure when other acute organ support is received.
l Neurological– indicated by one or more of central nervous system depression that was sufficient to
prejudice the airway and protective reflexes (except when caused by sedation prescribed to facilitate mechanical ventilation or by poisoning, e.g. deliberate or accidental self-administered overdose, alcohol, drugs, etc.); receipt of invasive neurological monitoring or treatment (e.g. intracranial pressure monitoring, jugular bulb sampling, external ventricular drain, etc.); receipt of continuous intravenous medication to control seizures and/or for continuous cerebral monitoring; or receipt of therapeutic hypothermia using cooling protocols or devices.
l Gastrointestinal– indicated by receipt of PN or EN (i.e. any method of feeding other than normal
Appendix 5 Patient follow-up cover letter
<TITLE FIRSTNAME SURNAME> <ADDRESS 1>
<ADDRESS 2> <ADDRESS 3> <POSTCODE>
DATE
Dear <TITLE> <SURNAME>
Re: CALORIES: a study evaluating the clinical and cost-effectiveness of early nutritional support in critically ill patients via the parenteral versus the enteral route
When you were treated at <NAME OF HOSPITAL> in <MONTH, YEAR>, you may remember that you agreed to take part in a research study called CALORIES, which is comparing two different methods of feeding patients. A Patient Newsletter is enclosed which contains further information about CALORIES.
As part of the study, we are contacting patients <THREE MONTHS/ONE YEAR> after they were admitted to hospital to find out about their general health and well-being. We would be very grateful if you would complete the enclosed questionnaire – this should only take about 15 minutes of your time. A stamped, self-addressed envelope is provided for ease of return.
The CALORIES Study, coordinated by the Intensive Care National Audit & Research Centre (ICNARC), is being conducted in 28 NHS hospitals and general information about the trial is available at the following website: www.icnarc.org. If you have any questions, or would like help completing the questionnaire, please contact the CALORIES Team at ICNARC (contact details above).
Thank you very much for your time. If you do not wish to fill in the questionnaire, please tick the relevant box on the questionnaire and return to us in the stamped self-addressed envelope provided.
Yours sincerely
Chief Investigator, CALORIES Encs:
Version 2.1 23/10/2013 Patient Trial number: <NUMBER>
If you are the carer for the person to whom this letter is addressed and they are unable to read it, we would be very grateful if you could take the time to read this letter and the Patient Information Sheet on their behalf. If you feel that they would like to participate, please complete the questionnaire either with them or on their behalf. By better understanding the recovery of the person you care for, we hope to improve the care of future patients admitted to critical care units.
Appendix 6 Patient follow-up questionnaire
Trial Number: «Patient_trial_ID»
CALORIES: a multicentre, randomised controlled trial comparing the clinical and cost-effectiveness of early nutritional support in critically ill patients via the parenteral versus the enteral route
We would be grateful if you would complete this questionnaire. The CALORIES trial aims to improve the care of critically ill patients.
A pen is provided and a FREEPOST envelope for return of the questionnaire. Please answer multiple
choice questions by putting a in ONE BOX for each question.
Please complete today’s date below:
/
/
Day Month Year
Please also let us know whether you completed this questionnaire: Alone
With help
Or it was completed by someone who cares for you