Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan
Francis Pike, Donald M Yealy, John A Kellum, David T Huang, Amber E Barnato, Tammy L Eaton, Derek C Angus, Lisa A Weissfeld, ProCESS Investigators, E Kulstad, H Watts, K Hesse, A Venkat, M Marynowski, S Livingston, P Hou, A Massaro, S Parmar, A Limkakeng, J Govert, W Drake, T Delbridge, K Brewer, A Mainhart, A Dorfman, L Chawla, E Brasha-Mitchell, C Grissom, T Allen, B Briggs, H Belzberg, S Swadron, J Zhu, T Arnold, S Conrad, K Hutchinson, F LoVecchio, R Carlson, M Mulrow, M Filbin, A Waxman, B A Parry, T Ellender, C Naum, C Lynn, A Sarna, T Slesinger, T Pastrana, J Fine, M Carius, C Belden, T Terndrup, M Wojnar, S Nafeei, M Strehlow, R Pearl, V Ojha, S Wilber, B Martin, J Skruck, R Sinert, S Malhotra, D Orban, R Paula, C Targal, J Ufberg, J Travaline, A Wang, E Panacek, T Albertson, L Jones, H Wang, K Lai, J Palmer, T Holmes, E Sides, N Schmiechen, C Weinert, S Nagamatsu, D Yealy, S Gunn, P Carey, R Wadas, V Okwiya, E Kimball, E Harris, R Preston, W Self, D Dubinski, M Goyal, C Phillips, R Migues, Francis Pike, Donald M Yealy, John A Kellum, David T Huang, Amber E Barnato, Tammy L Eaton, Derek C Angus, Lisa A Weissfeld, ProCESS Investigators, E Kulstad, H Watts, K Hesse, A Venkat, M Marynowski, S Livingston, P Hou, A Massaro, S Parmar, A Limkakeng, J Govert, W Drake, T Delbridge, K Brewer, A Mainhart, A Dorfman, L Chawla, E Brasha-Mitchell, C Grissom, T Allen, B Briggs, H Belzberg, S Swadron, J Zhu, T Arnold, S Conrad, K Hutchinson, F LoVecchio, R Carlson, M Mulrow, M Filbin, A Waxman, B A Parry, T Ellender, C Naum, C Lynn, A Sarna, T Slesinger, T Pastrana, J Fine, M Carius, C Belden, T Terndrup, M Wojnar, S Nafeei, M Strehlow, R Pearl, V Ojha, S Wilber, B Martin, J Skruck, R Sinert, S Malhotra, D Orban, R Paula, C Targal, J Ufberg, J Travaline, A Wang, E Panacek, T Albertson, L Jones, H Wang, K Lai, J Palmer, T Holmes, E Sides, N Schmiechen, C Weinert, S Nagamatsu, D Yealy, S Gunn, P Carey, R Wadas, V Okwiya, E Kimball, E Harris, R Preston, W Self, D Dubinski, M Goyal, C Phillips, R Migues
Abstract
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.
Source: PubMed