Patient data were recorded by using either online data collection software (provided by
iMD
soft, Tel Aviv, Israel) or the SAPS 3 stand-alone database system (provided by the CCC). The latter software used a Microsoft Access database (Microsoft Corporation, Redmond, WA, USA) for data storage and needed no Internet connection for data entry. Both systems maintained a variety of plausibility controls to ensure the quality of the recorded data. Each variable was precisely defined before the start of data collection (see Appendix C of the ESM). Detailed definitions of the variables were available to participants in both paper and electronic form. To facilitate plausibility checking, each variable was assigned a probability range, encompassing the range of probable values for that variable. In addition, a range of possible values (storage range) for that variable was defined (e.g., for FiO
2, no values <21% or >100% could be accepted). Thus, formal plausibility controls in the software systems were used wherever possible and ensured the maximum of data quality checking during data collection.
Participants who could not use one of the two software options were allowed to record the data on paper forms and submit them to the CCC (
n=26 ICUs). Patient data were then entered into the SAPS 3 stand-alone software system and thus checked for plausibility. In cases of uncertainty, ICU coordinators were contacted for clarification.
In addition, each ICU received a questionnaire with detailed questions about ICU structures and about resources available in other areas of the hospital.
Data were collected at ICU admission, on days 1, 2 and 3, and on the last day of the ICU stay. Data from the day of admission (aside from sociodemographic data such as age and sex) were categorized into different levels: (i) data about the condition of the patient before ICU admission, such as chronic conditions and medical diseases; (ii) data about the patient’s condition at ICU admission, such as the reason for admission, infection at admission, and surgical status; and (iii) data about the patient’s physiologic derangement at ICU admission. These data were collected within an hour before or after ICU admission.
On the following days of the ICU stay, further information was collected: severity of illness, as measured by the SAPS II [5 (
link)]; number and severity of organ dysfunction, as measured by the Sequential Organ Failure Assessment (SOFA) [28 ]; length of ICU and hospital stay; and outcome data, including vital status at ICU and hospital discharge. All patients were subjected to mandatory follow-up until hospital discharge, but not longer than 90 days after ICU admission. Patients still remaining in the hospital at 90 days were at that time classified as being “still in the hospital”.
To record diagnoses, a three-level system was used. (i) An a
cute medical disease was recorded for all patients, independent of surgical status, i.e., the acute (or acute on chronic) disease that best explained the ICU admission. If the reason for ICU admission was infectious disease, then this was recorded. (ii)
Surgical status at admission and the anatomic site of surgery were recorded for all patients undergoing surgery during the hospital stay before ICU admission. (iii) A concrete
reason for admission had to be selected. At least one reason for admission was required, but several selections were possible (one within each organ system). If no other reason was present, at least “basic and observational care” had to be selected.
All participants received detailed documentation of patient- and ICU-based data items as well as a detailed description of the data collection process. Moreover, specific forms to check the completeness of the patient-based documentation were provided. Additionally, a training session for ICU coordinators was organised at the 15th Annual Congress of the ESICM in Barcelona, Spain, before the start of data collection. Throughout the project, the project website (
http://www.saps3.org) provided all necessary information. In addition, the CCC was available to answer questions by email, fax and phone. Data were to be collected from all consecutively admitted patients between 14 October and 15 December 2002. ICUs with a high number of beds (and thus also admissions) could stop patient enrolment after contributing 100 patients.
Metnitz P.G., Moreno R.P., Almeida E., Jordan B., Bauer P., Campos R.A., Iapichino G., Edbrooke D., Capuzzo M, & Le Gall J.R. (2005). SAPS 3—From evaluation of the patient to evaluation of the intensive care unit. Part 1: Objectives, methods and cohort description. Intensive Care Medicine, 31(10), 1336-1344.