Accepted for Publication: July 28, 2014.
Published Online: November 17, 2014. doi:10.1001/jamainternmed.2014.5479.
Study concept and design: Miller, Weaver, Bahraini, Churchill, Deru, Ricciardi, Fracisco, Close, Brenner.
Acquisition, analysis, or interpretation of data: Weaver, Bahraini, Churchill, Price, Skiba, Caviness, Mooney, Hetzell, Surrett, Bartos, Ryan, Brenner.
Drafting of the manuscript: Miller, Weaver, Hetzell, Deru, Brenner.
Critical revision of the manuscript for important intellectual content: Miller, Weaver, Bahraini, Churchill, Skiba, Mooney, Hetzell, Deru, Brenner.
Statistical analysis: Miller, Hetzell, Liu.
Obtained funding: Miller, Weaver, Ricciard.
Administrative, technical, or material support: Miller, Weaver, Bahraini, Churchill, Deru, Fracisco, Close, Brenner.
Study supervision: Miller, Weaver, Churchill, Brenner.
Conflict of Interest Disclosures: None reported.
Funding/Support: The HOPPS trial was funded by the Defense Health Program and was managed by the US Army Medical Materiel Development Activity. The Naval Health Research Center and Army Contracting Command contracted support throughout this trial.
Role of the Funder/Sponsor: The sponsor of this trial is the US Army Office of the Surgeon General, who holds the investigational new drug application for hyperbaric oxygen to treat traumatic brain injury. The sponsor’s representative is the US Army Medical Research and Materiel Command. The sponsor had no role in the design of the study and provided support staff to ensure good clinical practice compliance. The sponsor and representative had the right to review the manuscript but had no authority to change any aspect of it.
Group Information: The HOPPS Trial Team Investigators were the following: Recruiting Center, Hyperbaric Medicine Department, LDS Hospital: Susan Churchill, Kayla Deru, and Kate Hak. Fort Carson Army Community Hospital: Heidi Terrio, Laura Grogan, Mike Anderson, and Simon Robertson. Naval Hospital Camp Lejeune: Jason Gordon, Dan Lesley, Tom Johnson, and Dawn Mitchell. Naval Hospital Camp Pendleton: Peter Zamfirescu, Scott Sparks, Illy Dominitz, Stephen Fischer, Jason Roby, James Chung, Lisa Tangredi, and William Howes. Eisenhower Army Medical Center: Joel Raintree, Michael Madsen, Jack Rigg, Austin Chhoeu, Otto Boneta, Eric Helling, Eric Martin, Herb Yeager, and Matthew Salak. Veterans Integrated Service Network 19: Maria Devore and Leah Russell. Henry M. Jackson Foundation: Jami Egan, Mark Greeder, Jennifer Gardino, Caron Wilbur, Kris Spalloni, Barbara Mayhugh, Tiffany Cripps, Ashlea Raynor, Karen Bartku, Linda Corkhill, Delia Marshall, Kilwanna Bush-Brown, Nancy Sickafoose, Rachael Anderson, and Alayna Capo. OxyHeal Health Group: Dana Hahn, Phil Treadway, Debbie Treadway, John Gross, Robert Samonte, James Rife, Michael Eastman, Dustin Halper, Eddie Johnson, Mike Fogie, Arturo Morales, Carlos Lewis, Daniel Jarmillo, Nicole Garrett, and Preston Burrell. Regulatory: Cheryl Dicks, Belinda Wagner, and Kevin Marrs. Clinical Operations: Lorena DiRienzo, Melissa Askin, Shannon Berg, Ernest Yribe, Kirsten Smith, Jim Bell, and Brendan Murphy. Data and Safety Management: Devin Hunt, Dixion Rwaksyaguri, and Doug Domalik. Administrative Support: Kyle Martin, Ilka DeLeon, Krista Mormon, and Christie Lawrence.
Disclaimer: The authors are solely responsible for the content of this article, which does not necessarily reflect the views of the US Army, the US Navy, the Department of Defense, or the Department of Veterans Affairs.
Additional Contributions: OxyHeal Health Group supported the installation, maintenance, and use of the additional hyperbaric chambers used in this study. We thank our study service members who not only sacrificed in combat in defense of our country but volunteered to help others struggling from the effects of traumatic brain injury and posttraumatic stress disorder.