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Alternative Clinical Trial Design in Neurocritical Care

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Abstract

Neurocritical care involves the care of highly complex patients with combinations of physiologic derangements in the brain and in extracranial organs. The level of evidence underpinning treatment recommendations remains low due to a multitude of reasons including an incomplete understanding of the involved physiology; lack of good quality, prospective, standardized data; and the limited success of conventional randomized controlled trials. Comparative effectiveness research can provide alternative perspectives and methods to enhance knowledge and evidence within the field of neurocritical care; these include large international collaborations for generation and maintenance of high quality data, statistical methods that incorporate heterogeneity and individualize outcome prediction, and finally advanced bioinformatics that integrate large amounts of variable-source data into patient-specific phenotypes and trajectories.

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Acknowledgments

The Second Neurocritical Care Research Conference was funded by the National Institutes of Health (NINDS) (R13 NS077610, PI: Suarez JI), the Integra Foundation, and the Baylor St Luke’s Medical Center in Houston, TX.

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Correspondence to Christos Lazaridis.

Additional information

Members of the Second Neurocritical Care Research Conference Investigators are listed in “Appendix”.

Appendix

Appendix

List of Second Neurocritical Care Research Conference Investigators in alphabetical order

Abdelhak Tamer, MD, Henry Ford Hospital, Detroit, MI; Aisiku Imolgele, MD, UT Houston, Houston, TX; Alderazai Yazan, MD, UT Houston, Houston, TX; Safdar Ansari, MD, Baylor College of Medicine, Houston, TX; Armstead William, MD, University of Pennsylvania, Philadelphia, PA; Badjatia Neeraj, MD, Columbia University, New York, NY; Bele Sylvia, MD, Regensburg, Germany; Bernard Francis, MD, University of Montreal, Montreal, Quebec; Bershad Eric, MD, Baylor College of Medicine, Houston, TX; Bowman Deanna, Hemedex Inc, Cambridge, MA; Bowman Frederick, PhD, Hemedex Inc, Cambridge, MA; Calvillo Eusebia, RN, Baylor College of Medicine, Houston, TX; Castillo-Abrego Guadalupe, MD, Panama City, Panama; Cava Luis, MD, University of Colorado, Denver, CO; Chang Cherylee, MD, Queens Medical Center, Honolulu, HI; Chesnut Randall, MD, University of Washington, Seattle, WA; Chhangani Sanjeev, MD, Massachusetts General Hospital, Boston, MA; Chumbe Maria, MD, Insituto Neurologico, Lima, Peru; Ciro-Quintero Juan Diego, MD, Clinica Las Americas, Medellin, Colombia; Citerio Giuseppe, MD, San Gerardo Hospital, Monza, Italy; Clark Robert, MD, PhD, University of Pittsburgh, Pittsburgh, PA, Coffey Lisa, Hemedex Inc, Cambridge, MA; Corry Jesse, MD, Marshfield Clinic, Marshfield, WI; Coplin William, MD, Wayne State University, Detroit, MI; Dhar Rajat, MD, Washington University, St Louis, MO; Diringer Michael, MD, Washington University, St Louis, MO; Divani Afshin, PhD, University of Minnesota, Minneapolis, MN; Domingues Joao, MD, Brazil; Elzammar Ziad, MD, SUNY Upstate Medical University, Syracuse, NY; Ezzedine Mustapha, MD, University of Minnesota, Minneapolis, MN; Figolt Doug, Codman Neuro, Raynham, MA; Figueroa Stephen, MD, UT Southwestern, Dallas, TX; Freeman William, MD, Mayo Clinic, Jacksonville, Fl; Fugate Jennifer, MD, Mayo Clinic, Rochester, MN; Fuse Akira, MD, Nippon Medical School, Tokyo, Japan; Geocadin Romergryko, MD, Johns Hopkins University, Baltimore, MD; Giraldo Elias, MD, Drexel University College of Medicine, Philadelphia, PA; Girardeau Rosemarie, RN, Integra Neurosciences, Plainsboro, NJ; Glassner Stuart, MD, University of Miami, Miami, Fl; Gomez Mauricio, MD, Los Angeles, CA; Goodman Jerry, MD, Baylor College of Medicine, Houston, TX; Gopinath Shankar, MD, Baylor College of Medicine, Houston, TX; Gress Daryl, MD, University of Viriginia, Charlottesville, VA; Grocott Hilary, MD, University of Manitoba, Winnipeg, MB; Gupta Puneet, MD, UT Southwestern, Dallas, TX; Haider Huma, Baylor College of Medicine, Houston, TX; Halinger Mangat, MD, Cornell University, New York, NY; Hall Casey, MD, Emory University, Atlanta, GA; Hall Christiana, MD, UT Southwestern, Dallas, TX; Hannawi Yousef, MD, Baylor College of Medicine, Houston, TX; Hemphill J Claude, MD, PhD, UCSF, San Francisco, CA; Hernandez Olga H, MD, Instituto Neurologico de Colombia, Medellin, Colombia; Hinson Holly, MD, OHSU, Portland, OR; Hocker Sara, MD, Mayo Clinic, Rochester, MN; Jones Elizabeth, RN, Baylor St Luke’s Medical Center, Houston, TX; James Michael, MD, Duke University, Durham, NC; Jichici Draga, MD, McMaster University, Hamilton, ON; Kapinos Gregory, MD, North Shore Hospital LIJ, Long Island, NY; Kirkpatrick Peter, University of Cambridge, Cambridge, UK; Ko Nerissa, MD, UCSF, San Francisco, CA; Kofke Andrew, MD, University of Pennsylvania, Philadelphia, PA; Koterba Edwin, MD, University of Sao Paulo, Brazil; Kramer Andreas, MD, Calgary, AB; Kuramatsu Joji, MD, Univ of Erlangen, Germany; Kutsogiannis Demetrios, MD, University of Alberta, Edmonton, AB; Latorre Julius, MD, SUNY Upstate Medical University, Syracuse, NY; Lazaridis Christos, MD, Baylor College of Medicine, Houston, TX; Ledoux David, MD, North Shore Hospital LIJ, Long Island, NY; Lee Jennifer, MD, Baylor College of Medicine, Houston, TX; Leroux Peter, MD, University of Pennsylvania, Philadelphia, PA; Liebschner Michael, PhD, Baylor College of Medicine; Livesay Sarah, RN, PhD, Baylor St Luke’s Medical Center, Houston, TX; Lopez Hubiel, MD, CEDIMAT, Dominican Republic; Luedtke Michael, Codman Neuro, Raynham, MA; Maas Andrew, MD, University Hospitals Antwerp, Belgium; Mandava Pitchaiah, MD, PhD, Baylor College of Medicine, Houston, TX; Manno Edward, MD, CCF, Cleveland, OH; March Karen, RN, Integra Neurosciences, Plainsboro, NJ; Martin Renee, PhD, MUSC, Charleston, SC; McCullough Laurence, PhD, Baylor College of Medicine, Houston, TX; Mejia Jorge H, MD, Fundacion Valle del Lili, Colombia; Miller Emmy, RN, PhD, Baylor College of Medicine, Houston, TX; Mizrahi Eli, MD, Baylor College of Medicine, Houston, TX; Moberg Richard, PhD, Moberg Research, Ambler, PA; Molyneaux Bradley, MD, Massachusetts General Hospital, Boston, MA; Muehlschlegel Susanne, MD, Dr med, UMass, Worcester, MA; Murthy Harish, MD, Good Samaritan Hospital, San Jose, CA; Murthy Santosh, MD, Baylor College of Medicine, Houston, TX; Norris Gregory, MD, Wayne State University, Detroit, MI; Nguyen Thuy, PharmD, Baylor St Luke’s Medical Center, Houston, TX; Nyquist Paul, MD, PhD, Johns Hopkins University, Baltimore, MD; Olson Daiwai, RN, PhD, Duke University, Durham, NC; O’Phelan Kristine, MD, University of Miami, Miami, FL; Palesch Yuko, PhD, MUSC, Charleston, SC; Parikh Gunjan, MD, Columbia University, New York, NY; Park Soojin, MD, University of Pennsylvania, Philadelphia, PA; Prado Darwin, MD, Rio de Janeiro, Brazil; Rajajee Venkatakrishna, MD, University of Michigan, Ann Arbor, MI; Ramirez Jorge, MD, San Jose, Costa Rica; Venkatasubba Rao Chethan P, MD, Baylor College of Medicine, Houston, TX; Rehman Mohammed, MD, Henry Ford Hospital, Detroit, MI; Rethnam Rajesh, MD, Houston, TX; Rigamonti Andrea, MD, University of Toronto, Toronto, ON; Robertson Claudia, MD, Baylor College of Medicine, Houston, TX; Rosand Jonathan, MD, Massachusetts General Hospital, Boston, MA; Rymer Marilyn, MD, St Luke’s Hospital, Kansas City, MO; Sachdev Harmeet, MD, Good Samaritan Hospital, San Jose, CA; Sarwal Aarti, MD, Wake Forest University, Winston Salem, NC; Schmidt Michael J, PhD, Columbia University, New York, NY; Schneck J MICHAEL, MD, Loyola University, Chicago, Il; Schneider Hauke, MD, Technical University, Dresden,Germany; Seder David, MD, Tufts University, Boston, MA; Shah Shreyansh, MD, Baylor College of Medicine, Houston, TX; Sheth Kevin, MD, University of Maryland, Baltimore, MD; Shutter Lori, MD, University of Cincinnati, Cincinnati, OH; Siegel Sherry, MD, Integra Neurosciences, Plainsboro, NJ; Silva Ricardo, MD, Rio de Janeiro, Brazil; Smirnakis Stelios M, MD, PhD, Baylor College of Medicine, Houston, TX; Souter Michael, MD, University of Washington, Seattle, WA; Staykov Dimitre, MD, University of Erlangen, Germany; Stiver Shirley, MD, UCSF, San Francisco, CA; Suarez Jose I, MD, Baylor College of Medicine, Houston, TX; Sung Gene, MD, University of Southern California, Los Angeles, CA; Suri Muhammad Fareed, MD, University of Minnesota, Minneapolis, MN; Tirschwell David, MD, University of Washington, Seattle, WA; Torbey Michel, MD, OSU, Columbus, OH; Trapuzzano Gary, Moberg Research, Ambler, PA; Treggiari Miriam, MD, University of Washington, Seattle, WA; Turgeon Alexis, MD, Universite Laval, Quebec, Quebec; Urfy Zain, MD, Baylor College of Medicine, Houston, TX; Varelas Panayiotis, MD, PhD, Henry Ford Hospital, Detroit, MI; Villalobos Luis, MD, Buenos Aires, Argentina; Wijman Christine, MD, PhD, Stanford University, Palo Alto, CA; Yonas Howard, MD, University of New Mexico, Albuquerque, NM; Yuste Fernando, MD, BARD Medical, Covington, GA; Zafar Sahar, MD, Baylor College of Medicine, Houston, TX; Zygun David, MD, University of Calgary, Calgary, AB.

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Lazaridis, C., Maas, A.I.R., Souter, M.J. et al. Alternative Clinical Trial Design in Neurocritical Care. Neurocrit Care 22, 378–384 (2015). https://doi.org/10.1007/s12028-015-0135-8

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