Use of a multi-level mixed methods approach to study the effectiveness of a primary care progressive return to activity protocol after acute mild traumatic brain injury/concussion in the military.
The large number of U.S. service members diagnosed with concussion/mild traumatic brain injury each year underscores the necessity for clear and effective clinical guidance for managing concussion. Relevant research continues to emerge supporting a gradual return to pre-injury activity levels without aggravating symptoms; however, available guidance does not provide detailed standards for this return to activity process. To fill this gap, the Defense and Veterans Brain Injury Center released a recommendation for primary care providers detailing a step-wise return to unrestricted activity during the acute phase of concussion. This guidance was developed in collaboration with an interdisciplinary group of clinical, military, and academic subject matter experts using an evidence-based approach. Systematic evaluation of the guidance is critical to ensure positive patient outcomes, to discover barriers to implementation by providers, and to identify ways to improve the recommendation. Here we describe a multi-level, mixed-methods approach to evaluate the recommendation incorporating outcomes from both patients and providers. Procedures were developed to implement the study within complex but ecologically-valid settings at multiple military treatment facilities and operational medical units. Special consideration was given to anticipated challenges such as the frequent movement of military personnel, selection of appropriate design and measures, study implementation at multiple sites, and involvement of multiple service branches (Army, Navy, and Marine Corps). We conclude by emphasizing the need to consider contemporary approaches for evaluating the effectiveness of clinical guidance.
Defense and Veterans Brain Injury Center, 1335 East West Highway, Silver Spring, MD 20910, United States; General Dynamics Health Solutions, 8601 Georgia Ave Ste. 900, Silver Spring, MD 20910, United States. Electronic address: emma.d.gregory2.ctr@mail.mil.
Emma
E
Gregory
US Army Medical Research and Materiel Command, Combat Casualty Care Research Program, 722 Doughten Street, Fort Detrick, MD 21792, United States.
Therese A
TA
West
Defense and Veterans Brain Injury Center, 1335 East West Highway, Silver Spring, MD 20910, United States; General Dynamics Health Solutions, 8601 Georgia Ave Ste. 900, Silver Spring, MD 20910, United States; Womack Army Medical Center, MCXC-TBI 2817 Reilly Road, Fort Bragg, NC 28310, United States.
Wesley R
WR
Cole
Defense and Veterans Brain Injury Center, 1335 East West Highway, Silver Spring, MD 20910, United States; General Dynamics Health Solutions, 8601 Georgia Ave Ste. 900, Silver Spring, MD 20910, United States; Naval Hospital Camp Pendleton, 33 Area, Camp Margarita, Mental Health Building 33305, Camp Pendleton, CA 92055, United States.
Jason M
JM
Bailie
University of North Carolina Chapel Hill, 321 S. Columbia Street, Bondurant Hall Ste 3024, Chapel Hill, NC 27599, United States; Venesco LLC, 14801 Murdock Street Suite 125, Chantilly, VA 20151, United States.
Karen L
KL
McCulloch
Defense and Veterans Brain Injury Center, 1335 East West Highway, Silver Spring, MD 20910, United States; Naval Medical Center San Diego, Department of Physical Medicine and Rehabilitation, 34730 Bob Wilson Dr. Ste #201 Bldg 3, San Diego, CA. 92134, United States; American Hospital Services Group LLC, 1 E. Uwchlan Ave, Suite 407, Exton, PA 19341, United States.
Mark L
ML
Ettenhofer
Defense and Veterans Brain Injury Center, 1335 East West Highway, Silver Spring, MD 20910, United States; Venesco LLC, 14801 Murdock Street Suite 125, Chantilly, VA 20151, United States.
Amy
A
Cecchini
Defense and Veterans Brain Injury Center, 1335 East West Highway, Silver Spring, MD 20910, United States.
Felicia M
FM
Qashu
D000293:Adolescent; D000328:Adult; D001924:Brain Concussion / Q000628:therapy*; D000070642:Brain Injuries, Traumatic / Q000628:therapy; D002985:Clinical Protocols; D005260:Female; D015600:Glasgow Coma Scale; D006801:Humans; D008297:Male; D008875:Middle Aged; D008887:Military Medicine / Q000379:methods*; D008889:Military Personnel; D055361:Multilevel Analysis; D017410:Practice Guidelines as Topic; D011320:Primary Health Care / Q000379:methods*; D062707:Return to Work; D015599:Trauma Severity Indices; D055815:Young Adult
Clinical study methodology; Concussion; Knowledge translation; Military; Outcomes research; Traumatic brain injury