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Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.

Publication ,  Journal Article
Pike, F; Yealy, DM; Kellum, JA; Huang, DT; Barnato, AE; Eaton, TL; Angus, DC; Weissfeld, LA; ProCESS Investigators,
Published in: Crit Care Resusc
December 2013

BACKGROUND: The Protocolized Care for Early Septic Shock study is a randomised, multicentre, prospective, three-arm, parallel-group trial of alternative resuscitation strategies for early septic shock. OBJECTIVE: To state our analysis plan for trial data. METHODS: Our plan is to guide data collection and analysis using pre-existing definitions and testing, with local consensus-based efforts where needed. We examine protocolised care (two experimental approaches) and compare this to usual "wild type" care. RESULTS: Our plan is to address three aims (clinical efficacy, biology of illness and recovery, and costs and cost-effectiveness) and four hypotheses, and we specify rules for handling data and determining outcomes. CONCLUSION: By using measures to maintain study conduct and analysis rigour, we hope to improve understanding of early septic shock resuscitation and care of patients.

Duke Scholars

Published In

Crit Care Resusc

ISSN

1441-2772

Publication Date

December 2013

Volume

15

Issue

4

Start / End Page

301 / 310

Location

Netherlands

Related Subject Headings

  • Shock, Septic
  • Resuscitation
  • Renal Replacement Therapy
  • Prospective Studies
  • Outcome Assessment, Health Care
  • Multicenter Studies as Topic
  • Humans
  • Hospital Mortality
  • Data Interpretation, Statistical
  • Critical Care Nursing
 

Citation

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Pike, F., Yealy, D. M., Kellum, J. A., Huang, D. T., Barnato, A. E., Eaton, T. L., … ProCESS Investigators, . (2013). Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan. Crit Care Resusc, 15(4), 301–310.
Pike, Francis, Donald M. Yealy, John A. Kellum, David T. Huang, Amber E. Barnato, Tammy L. Eaton, Derek C. Angus, Lisa A. Weissfeld, and Lisa A. ProCESS Investigators. “Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.Crit Care Resusc 15, no. 4 (December 2013): 301–10.
Pike F, Yealy DM, Kellum JA, Huang DT, Barnato AE, Eaton TL, et al. Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan. Crit Care Resusc. 2013 Dec;15(4):301–10.
Pike, Francis, et al. “Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.Crit Care Resusc, vol. 15, no. 4, Dec. 2013, pp. 301–10.
Pike F, Yealy DM, Kellum JA, Huang DT, Barnato AE, Eaton TL, Angus DC, Weissfeld LA, ProCESS Investigators. Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan. Crit Care Resusc. 2013 Dec;15(4):301–310.

Published In

Crit Care Resusc

ISSN

1441-2772

Publication Date

December 2013

Volume

15

Issue

4

Start / End Page

301 / 310

Location

Netherlands

Related Subject Headings

  • Shock, Septic
  • Resuscitation
  • Renal Replacement Therapy
  • Prospective Studies
  • Outcome Assessment, Health Care
  • Multicenter Studies as Topic
  • Humans
  • Hospital Mortality
  • Data Interpretation, Statistical
  • Critical Care Nursing