Transcription of DETAILED STATISTICAL ANALYSIS PLAN (SAP)
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DETAILED STATISTICAL ANALYSIS PLAN (SAP)
STATISTICAL ANALYSIS plan Simple Intensive Care Studies-I 1 DETAILED STATISTICAL ANALYSIS PLAN (SAP) 1. Administrative information Title, registration, versions and revisions Full study title A prospective observational study on the value of conventional hemodynamic parameters in estimating cardiac output and predicting mortality in critically ill patients Acronym Simple Intensive Care Studies-I (SICS-I) Local project number 201500144 number NCT02912624 Study protocol version (23 September 2016) SAP version (3 April 2018) SAP revision history None SAP revision justification - SAP revision timing Revision will be conducted after publishing the two main manuscripts. This revision will concern DETAILED SAPs for each sub-study. STATISTICAL ANALYSIS plan Simple Intensive Care Studies-I 2 Roles and responsibility Author Bart Hiemstra1 Statistician Ilja M. Nolte2 Principle investigator Iwan van der Horst1 Contributors and roles Pim van der Harst3: revised the SAP Frederik Keus1: contributed to the design and revised the SAP Harold Snieder2: revised the SAP Chris HL Tio2: main contributor to the section missing data Jos N Alves Castela Cardoso Forte1: drafted the section additional analyses: machine learning J rn Wetterslev4: contributed to the design and revised the SAP.
diagnostic and prognostic value of a comprehensive selection of clinical and haemodynamic variables in the critically ill (7). Prospective registration of protocols of observational studies are promoted to prevent outcome reporting bias (8,9). Likewise, prospective publication of a detailed statistical analysis plan (SAP) is
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