6
Suggestions for Analysis Plans by Working Groups

During the planning phase of the workshop, the steering committee compiled a list of 36 issues raised by stakeholders in the Military Health System (MHS) medical community related to the care of patients with mild, moderate, and severe traumatic brain injury (TBI) (see Appendix B). From this list, they identified the areas that could potentially benefit from operational systems engineering (OSE) approaches and categorized them into five major challenges for TBI care management:

  1. Development of new TBI knowledge

  2. Detection and screening of TBI conditions

  3. TBI care coordination and communication

  4. Measurement and forecasting of demand for TBI care

  5. TBI care system capacity, organization, and resource allocation

The committee then converted the stakeholder issues in these five categories into two or three issues for OSE analysis (i.e., analytical challenges that, if addressed effectively through OSE approaches, would answer important questions and help improve the performance of TBI care) (see Appendix C).

Forty of the 50 invited participants at the workshop (Appendixes F and G) were assigned, on the basis of their expertise, to one of the five working groups listed above.1 The OSE analysis issues and challenges assigned to each working group are listed below:

1

Steering committee co-chairs Norman Augustine and Denis Cortese and steering committee member Seth Bonder circulated among the five working groups.



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6 Suggestions for Analysis Plans by Working groups During the planning phase of the workshop, the steering committee compiled a list of 36 issues raised by stakeholders in the Military Health System (MHS) medical community related to the care of patients with mild, moderate, and severe traumatic brain injury (TBI) (see Appen- dix B). From this list, they identified the areas that could potentially benefit from operational systems engineering (OSE) approaches and categorized them into five major challenges for TBI care management: 1. Development of new TBI knowledge 2. Detection and screening of TBI conditions 3. TBI care coordination and communication 4. Measurement and forecasting of demand for TBI care 5. TBI care system capacity, organization, and resource allocation The committee then converted the stakeholder issues in these five categories into two or three issues for OSE analysis (i.e., analytical chal- lenges that, if addressed effectively through OSE approaches, would answer important questions and help improve the performance of TBI care) (see Appendix C). Forty of the 50 invited participants at the workshop (Appendixes F and G) were assigned, on the basis of their expertise, to one of the five working groups listed above.1 The OSE analysis issues and challenges assigned to each working group are listed below: Steering committee co-chairs Norman Augustine and Denis Cortese and steering com- 1 mittee member Seth Bonder circulated among the five working groups. 

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 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE • group A. Development of New TBI knowledge • A.1. Develop an approach to modeling the neuropathology and clinical dynamics of blast and concussive effects on brain function that lead to mild, moderate, or severe TBI. • A.2. Develop an acute-to-chronic disease model of mild trau- matic brain injury (mTBI). • group B. Detection and Screening of TBI Conditions • B.1. Develop a model for diagnosing mTBI based on clinical experience and cognitive testing. • B.2. Develop the structure and processes of an mTBI screen- ing program for use in theater and in the continental United States (CONUS). • group C. Coordination and Communication for TBI Care • C.1. Develop the structure of a TBI information system to track, monitor, and cue patients, families, and relevant providers. • C.2. Develop a methodology for coordinating the delivery of TBI care services immediately following trauma. • group D. Measuring and Forecasting the Demand for TBI Care • D.1. Based on historical data, develop a statistical estimate of TBI in the population of military personnel involved in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF). • D.2. Develop a methodology of forecasting the time stream of future TBI cases in the military population. • D.3. Develop elements of an assessment and a methodology for assessing the value of preventing TBI. • group E. Capacity, Organization, and Resource Allocations for a TBI Care System • E.1. Describe elements, processes, and activities to represent the dynamics of a complete course of TBI care as input for a model of a TBI care system. • E.2. Outline the structure of a model or methodology to assist in planning for the allocation of scarce TBI care providers in theater and in CONUS.

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS For each challenge, the working groups were asked to design a suggestion for an analysis plan, including an objective, a technical approach, an approach structure, data requirements, critical assump- tions and constraints, metrics, expected output, implementation actions, estimates of time and resource requirements, and other elements of a future OSE study or program that might be initiated to meet the target challenge. Specifically, working groups were asked to identify the types of approaches, methods, and information that could be developed by OSE practitioners to assist care providers and managers in delivering quality TBI care. Each group had a chairperson who served as the technical lead, a rapporteur who was responsible for summarizing and communicating the technical aspects of the group’s approach, and several experts in rel- evant subject matter. The group was asked to review its assigned tasks; modify them as appropriate; and develop analysis plans for a study, method, or means of data collection. Each group was also instructed to design its analysis plans so they could potentially be used by MHS. Group members offered individual suggestions and ideas for the devel- opment of the analysis plan, and no attempt was made to ensure a con- sensus. The chairman and rapporteur of each working group presented a summary of the group discussion to the full workshop. The five working groups were not Academy-appointed committees, and this summary reflects the views of the individuals who participated in each working group—not necessarily those of the institution or the workshop plan- ning committee. The analysis approach to each task comprised three parts: the issue itself (what each group was asked to do and the purpose of the task); the reasons the task was addressed (in terms of the stakeholder issues on which it was based); and the analysis output (the study, approach, or method that could be developed by implementing the analysis plan, essentially describing the capabilities of a specific model based on the suggested approach). Each plan for a future OSE study or program included an objec- tive stating what could potentially be achieved through this approach; a description of the technical approach to achieving the specified ob- jective; and an approach structure, including the variables considered for inclusion, the development of necessary relationships, important statistical and structural model formulations, and a description of how the technical approach would be implemented.

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 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE In addition, each group was asked to identify data that might have to be collected, as well as critical assumptions about future demand and data availability and critical constraints based on available measurement tools, sample sizes, and safety regulations. Each group also outlined metrics for evaluating performance, outcome, and utility and identified specific tasks for executing the suggested approach. Finally, each analysis plan included expected output, implementation actions, estimates of duration, and resource requirements. The following summaries of the suggestions for analysis plans are based on presentations by the chair and rapporteur of each group. It is important to reiterate that the analysis plans are suggestions developed by the working groups for the express purpose of illustrating potential applications of OSE tools and methods to a select sampling of specific TBI care challenges. The analysis plans should not be construed as consensus recommendations of the individual working groups, the workshop participants as a whole, or the National Academies. WORkINg gROuP A: DEvELOPMENT OF NEW TBI kNOWLEDgE2 The phenomenology surrounding TBI, particularly mTBI, is not completely understood. This limited understanding also limits objective diagnosis, the effective management of symptoms at the point of injury, and appropriate acute patient care. In addition, because little is known about the progression or disappearance of mTBI symptoms over long periods of time after exposure to a blast injury, the effectiveness of tri- age, rehabilitation, long-term disease management, and efficient use of community services for mTBI patients are all limited. Thus improving the understanding of TBI injuries and mechanisms is a crucial issue for TBI care providers and managers trying to develop effective treatment protocols. The two specific tasks assigned to Group A both focus on the development of new TBI knowledge. The first involved developing an approach to modeling the neuropathology and clinical effects of blast and concussive injuries on brain functions leading to mild, moderate, and/or severe TBI. The second task was to develop an acute-to-chronic See Appendix G for names of working group members. 2

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS disease model of mTBI showing the evolution of disease states or symp- toms over time for a population of mTBI patients, some who were ini- tially asymptomatic and some who were overtly symptomatic. Because of the need for better data collection on TBI to inform future research, the group also addressed a third issue, the establishment of a national database on brain trauma events in the civilian population. Issue 1: Methods of Measuring Brain vital Signs Issue 1 focuses on the development of methods of measuring brain vital signs in patients with blast and/or concussive injuries, that is, patients with TBI from blast, blast plus concussion, and concussion alone. The suggested technical approach includes animal and human studies using neuroimaging, neuropsychological testing, and neuropathology assess- ments to (1) measure temporal changes in the brain in vivo after a blast and/or concussive event and (2) identify biomarkers, brain edema, changes in brain blood flow and volume, and changes in neurochemistry. Once these brain changes and biomarkers have been identified, care providers can determine the efficacy of potential treatments, specific risk factors for the development of TBI, and effective prevention measures. One of the main challenges in treating mTBI is identifying who is affected and how their outcomes develop over time. Therefore, a necessary data requirement for this initiative would be pre-deployment neuropsychological screening to obtain baseline data on a sample of potential patients. The baseline data could then be compared to other pre-deployment and post-deployment tests for changes in brain chem- istry. Data would also be used to evaluate deployable, alternative, and inexpensive methods of measuring brain vital signs, including blood flow, blood volume, and brain edema. A serious problem in post-screening at various points in theater is patients’ denial of injury and the absence of symptoms. To address this problem, a research station could be established to analyze a group of patients and gather data prospectively at a Level II facility. Imaging research stations would also be beneficial at Level III, IV, and V MHS facilities and Department of Veterans Affairs (VA) facilities. These research stations would be capable of performing structural and func- tional magnetic resonance imaging (MRI) to measure brain anatomy. To gather baseline data on asymptomatic individuals exposed to blast for comparison with controls, each vehicle could carry a “black

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 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE box” equipped with sensors for characterizing the magnitude and other parameters of a blast. Individual soldiers could also be equipped with black boxes that could characterize the magnitude and specific effects of a blast on that particular soldier. The black boxes would collect neces- sary background information that is not otherwise available. Overall, gathering data on imaging and neuropsychological testing at early stages would make it possible to monitor and compare the effects of an injury event over time and provide a link between vital signs and estimates of event severity. Data are also needed for analyses of systematic gross pathology relative to a patient’s history, including information on previous TBIs, alcohol use, and mental health status. Information for such analyses might be collected from studies currently under way at academic and government research sites. Critical assumptions associated with the analysis plan described above include the capability of MRI at one echelon (at least) in theater; standardization of imaging and support of data collection at Level II through V facilities; and the availability of a technically competent staff. In addition, it is assumed that data will be available on human neuro- pathology, potentially from evaluations of data related to mortality dur- ing the Global War on Terror and that animal studies will accurately mimic the human condition. Critical constraints include obtaining military permission for in-theater research and access to postmortem neuropathological data and establishing a data repository to support collection and long-term analysis. MRI, position emission tomography, and single photon emis- sion computed tomography would also be necessary through Level V at TBI centers in CONUS. Other critical constraints are the execution of research proposals, the relevance of animal models to the human condi- tion, the feasibility of using large animal models to test neuropathology, and the variability of image interpretation among research staff. Performance, outcome, and utility metrics would include (1) the validation of animal models via human imaging studies and (2) the tracking of patients to ensure adequate throughput of those imaged with mTBI at Level II facilities, as well as those imaged with moderate to severe TBI at Level III through V MHS facilities and VA facilities. It would be necessary for one Level II facility to gather information on a group of patients and a group of control patients, with a minimum of 30 patients per group. Although clinical analyses of MRIs often miss

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS cases of mTBI, they still have some clinical utility because they provide data on ventricular volume and atrophy and can identify brain bleed- ing. This information is only available at Level II facilities if they are equipped with MRI imaging capabilities. In addition, neuropsychiatric testing could identify cognitive deficits and could thus be another metric for identifying health outcomes following TBI. Tasks to execute the approach described above would include con- vening a working group of neuropathologists to address questions about TBI and associated exposures and outcomes. Issues to consider include differences between concussive and blast injuries, appropriate measures for these two types of injury, and determining if there is consensus on the sequence of neuropathology after a blast trauma. Tasks would also include establishing a database of results from neuropathological studies and ongoing experiments at government research laboratories and academic institutions. In addition, research proposals would have to be developed to support the proposed animal experiments. Expected outputs include a determination of the differences between mild blast, mild concussive, and mild blast plus concussive injuries as revealed by MRI and neuropsychological measures; the classification of characteristics of mTBI patients who need additional medical surveil- lance and/or treatment; and the identification of temporal characteristics of blast/concussive exposure and longitudinal outcomes. For a single Level II site to implement this analysis plan, Group A estimated that the project would last approximately 18 months and would cost about $3.5 million for in-theater equipment. Data collec- tion would begin four months after initiation of the project and would require three active-duty personnel and two civilian personnel. Addi- tional support resources (e.g., security) would also be required. Issue 2: Anticipating Downstream Consequences of TBI The objective of Issue 2 is to provide a means of understanding and forecasting the downstream consequences of TBI, including both the later effects of immediate post-trauma treatment and interactions with subsequent TBI events or other psychological traumas. The tech- nical approach to meeting this objective involves modeling a finite state-space stochastic process in which the initial conditions are TBI incidents (timing and conditions), co-morbidity, and treatment. This model would also take into account instances with no co-morbidities

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 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE and cases in which no treatment was administered because the injuries were not reported. Necessary data would be collected on anomalies and triggering events and their associated consequences as a basis for developing a list of behaviors and types of triggering events that might be of concern in patients with TBI. Longitudinal data from a test sample of long- duration TBI victims (e.g., from the Vietnam Head Injury Study)3 would also be useful, along with data on short-duration victims (e.g., from Iraq and Afghanistan). In addition, new surveys would be designed and administered to capture the effects of long-duration TBI. Overall, the purpose would be to identify medical problems and behaviors of concern, such as neurodegeneration and adjustment disorder, that are likely to be manifested in 1, 5, 10, 20, or 30 years, as well as triggering events that may complicate TBI and/or accelerate the emergence of those conditions. Data collection would be focused on generating the structure of relevant TBI events to define the states of the system. (The state space would reflect the progression of the TBI patient from acute through chronic stages, and different states would reflect the treatment provided.) The data would redress our current lack of data, and hence our inability to define states and probability distributions of their occupancy times, as well as transitions between states. The initial data collection would involve analyses of patient records and 50 to 100 lengthy interviews for each group, followed by a more formal analysis instrument for samples of 1,000 to 2,000 patients. All data collection would be supplemented with meta-analysis and data mining, with the expectation that the results could suggest appropriate clinical trials of alternative treatments. The overall goal is to establish a baseline frame of reference for detecting changes in the state space. Thus the approach for this analysis plan would involve enumerating the characteristics of a TBI event, co- morbidities, treatment, and baseline characteristics of each victim. Simi- lar documentation of downstream consequences and potential physical and psychological sequelae would also be collected as a basis for making correlations among characteristics of the initial event, downstream con- sequences, and subsequent triggering events. National Naval Medical Center. Ongoing. Vietnam Head Injury Study (VHIS) Phase 3 III. Available online at http://www.bethesda.med.nay.mil/professional/research/ietnam_head_ injury.aspx (accessed September 29, 2008).

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS These correlations would require long- and short-term longitudinal histories of TBI patients from Vietnam and Iraq and Afghanistan, as well as appropriate control populations. The Vietnam population could provide an opportunity to examine long-term outcomes not yet realized in the Iraq and Afghanistan population; thus a cohort that was clearly identified as having been exposed to blast injuries in Vietnam would be selected to provide life histories and determine relevant outcomes since their exposures. Data on the forensics of TBI events, including relative location of the blast to the soldier and the type of vehicle the soldier was in when the blast occurred, would also be necessary to define the state at the conclusion of the event. Critical assumptions for this analysis plan include (1) data on TBI victims will be available as a basis for identifying appropriate initial in- terview samples as well as subsequent samples for longitudinal analyses, (2) sufficient patient recall to identify events of interest, and (3) adequate reporting of the salient events. No critical constraints for this analysis are anticipated other than the availability of funding. Metrics include (1) quality of life and its relationship to the events of interest, (2) treatment burden and costs, and (3) downstream needs for patient monitoring and response. Tasks necessary to execute this approach include (1) developing a proposal for the research, (2) secur- ing adequate funding, (3) obtaining an interview sample, (4) execut- ing interviews and preliminary analyses to generate the state space, (5) demonstrating an initial model based on the sample, (6) developing a formal instrument for data collection, and (7) using this instrument to prepare a model for initial application to TBI care. Expected outputs include (1) identification of potential warning signs of downstream consequences of TBI, (2) identification of immediate actions and treatment choices to minimize downstream consequences, (3) classification of a pattern of downstream consequences following a TBI event and its treatment and costs, and (4) comparison of long-term treatment strategies. It is estimated that this project would last four years and require approximately $1 million in funding, with initial operational results expected 18 months from the start-up date of the project. Issue 3: Database on Civilian TBI Events Issue 3 was to create, in cooperation with federal and state agencies and private organizations, a nationwide database of information on the

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0 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE effects of crashes, explosions, and other traumatic events on the health of the civilian population over time. Data on head injuries from brain trauma events in the civilian sector, many of which may require treat- ment similar to treatment of mTBI on the battlefield, would be made available for analytical and comparative purposes to provide insights into traumatic events on the battlefield. Explosions in chemical plants, natural-gas pipelines, grain silos, car crashes, and other events generate blasts that have many characteristics in common with munitions explo- sions. There are also important differences that may be significant in recognizing the effects of battlefield injuries. The national database would be continuously updated and made available for analysis by all interested parties. Data on the nature of brain trauma events, the surrounding conditions, the effects on personnel, and medical diagnoses of immediate and long-term effects would be required for implementation of this approach. A critical assumption is that data from brain trauma events in the civilian sector would provide information important to improving the un- derstanding of TBI effects in the military population. A critical constraint is that there is no central federal or civilian agency that could collect and archive data of this nature, let alone data detailed enough for analysis. Performance, outcome, and utility metrics include identification of the characteristics of brain trauma events, primary clinical effects on humans, primary effects on brain structures and their impacts on humans, and long-term clinical effects on humans. To execute this ap- proach, a federal program would have to be identified that would be responsible for receiving and archiving data, and a mandate or incentive system would have to be implemented to ensure that all traumatic brain events in the civilian sector were promptly reported to this agency. The expected output would be a large civilian database that MHS could use to augment its analysis of TBI and make comparisons with data col- lected in theater. Implementation of this approach would require identifying one or more advocates for the creation of the proposed database, as well as the development of an organizational structure to support the activity. Although the costs cannot be estimated at this time, this would be an ongoing effort, and resources to accomplish it would have to be carefully explored. The U.S. Department of Transportation, which collects data on vehicle crashes, and perhaps some other agencies or organizations, could provide some support.

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS WORkINg gROuP B: DETECTION AND SCREENINg OF TBI CONDITIONS4 MHS needs better testing (cognitive tests, brain scans, etc.) for TBI, particularly for mTBI. The test results and other information could be used to develop an effective, efficient screening process that takes into account Type I (sensitivity) and Type II (specificity) detection errors. In the case of mTBI, physical symptoms may not signal the extent of the injury. Moreover, the current screening system relies on self-reporting of TBI causative events or symptoms in theater or at the end of a de- ployment. This system has been less than effective because individuals have multiple disincentives for self-reporting both during and after a deployment.5 The costs of false positives and false negatives are significant. mTBI “false alarms” remove healthy soldiers from service at significant cost to the military mission. However, if undetected, mTBI can impair job per- formance during a deployment, putting the individual, other soldiers, and the mission at increased risk. If not detected and treated promptly, an initial mTBI increases a soldier’s risk of subsequent TBI and/or may result in long-lasting symptoms post-deployment that will degrade his or her quality of life. Unfortunately, little objective information is available about the onset and progression of mTBI that can be used to assist in detecting and screening for mTBI injuries. There is, however, a good deal of sub- jective information (e.g., medical experience; neurological, cognitive, and psychological testing; imaging; questionnaires), as well as data on the incidence of mTBI, that could conceivably be used as an interim diagnostic vehicle for assessment, detection, and screening programs and in making “return to duty” (RTD) decisions. Working Group B focused on two issues: (1) the development of systems engineering models for evaluating and improving the current TBI screening process, particularly for mTBI; and (2) the development of a predictive diagnostic model for mTBI (i.e., a means of estimating See Appendix G for names of working group members. 4 Disincentives are based on the stigma associated with the injury; soldiers’ reluctance 5 to risk being removed from their units; leaving their comrades in arms short-handed for an invisible or (mis)perceived “minor” injury; soldiers’ desire at the conclusion of a deployment to “just get home” and not prolong the post-deployment evaluation; and soldiers’ fears of the negative implications of a positive diagnosis for long-term military careers.

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0 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE care (more than 48 care programs have been developed). In the MHS this requires that each patient have a case manager (not a care provider) who serves as care coordinator. There is no evidence-based treatment for mTBI that accounts for multiple symptoms and co-morbidities. Thus an assessment of this care system must include analogues in the management of other complex diseases, such as diabetes and cancer. To manage differences between mTBI and other diseases, variabili- ties in case management in MHS and VA at different locations must be considered. At present, there is one track for mTBI identified in theater, another for other injuries occurring in conjunction with mTBI, and a third track for mTBI recognized only after a period of time following the incident. Although the first point of contact is responsible for a patient regardless of the evolution of the patient’s care, all patient care is ultimately the responsibility of specialists regardless of whether they have directly interacted with the patients. The technical approach to this analysis plan involves the develop- ment of a description of elements, processes, and activities to represent the dynamics of a complete episode of mTBI care for use in modeling a TBI care system at the enterprise level. This includes an outline of the structure of a model or methodology to assist in planning for the alloca- tion of scarce TBI care providers in theater and in CONUS. Thus the approach structure must define care paths that specify which functions are necessary and when branching and feedback paths occur and their associated criteria, and where most time is consumed in the system. Pro- cess maps would be developed, as necessary, and a model representation would be chosen with defined parameters (Figure 6-1). Data requirements would be identified for estimating these param- eters, and sensitivity analyses would be carried out to verify and test the model. Validation of the model would be accomplished through evalu- ation of the model relative to baseline data. Resource-allocation experi- ments would then be performed to assess, for example, the effectiveness and resource requirements for alternative disease-management protocols or the effectiveness of alternative distributions of a limited number of providers among multiple echelons of care. Data requirements for this analysis plan are divided into four categories: 1. known aspects of mTBI with available data 2. known aspects of mTBI with no available data

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From Level I Level II *Level III Evacuation Decision Red Flags: 1. Progressively declining level of Conduct evaluation: consciousness/neurological exam Perform entire MACE 2. Pupillary asymmetry Evaluate for red flags 3. Seizures 4. Repeated vomiting Treatment: Yes Are Level III 1. Headache management, use Acetominophen. Evacuation to Level III (as red flags* 2. Avoid tramadol, narcotics, NSAID’s, ASA, or operational considerations allow) present? other platelet inhibitors until CT confirmed negative. 3. Give an educational sheet to all positive mild TBI patients. No Any Is MACE score deterioration, Yes for Items IX to XIII Yes persistent symptoms, Evacuation to Level III Observe – up to 7 days under 25, or are there or positive findings on (as operational (command decision) any symptoms from repeat MACE considerations allow) Item VIII? after 7 days? No No Positive Repeat testing in 24 hours symptoms Positive or evacuate to Level III with exertional symptoms Yes (command decision) Yes exercise testing with exertional for 5 minutes exercise testing (sit -ups push-ups, , for 5 minutes run)? (sit-ups, push-ups, run)? No No RTD RTD FIguRE 6-1 Sample mTBI care-process map for Level II treatment facilities. SOURCE: DVBIC Working Group, 2006.  Figure 6-1.eps

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 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE 3. aspects of mTBI with a recognized lack of understanding 4. aspects of mTBI yet to be identified Present knowledge and currently available data are as follows: 11.2 percent of individuals surveyed in the military have reported mTBI; 50 percent of these individuals accessed care; and 10 to 20 percent of reports of mTBI are post-deployment (Labutta, 2008). In addition, both in theater and post-deployment reporting are currently designed to generate false positives. Ninety percent of care providers in the field use MACE,20 and 85 percent of civilian non-blast patients recover from their injuries within three months. Currently, we do not have substantiating data on the complete path of care in MHS, the effectiveness of rehabilitation therapy, or outcomes for those who return to work. Apparent issues identified with no supporting knowledge include the extent to which a TBI report indicates the presence of co-morbidities and the progression of TBI symptoms without treatment. Finally, there are still aspects of mTBI about which there is no information and no treatment. A major assumption for this analysis plan is that the plans developed by Groups A through D, including the development of new TBI knowl- edge, the detection and screening of TBI conditions, the coordination and communication of TBI care, and the forecasting of the demand for care, will all accomplish their objectives. Nevertheless, work on imple- menting the Group E analysis plan can proceed in parallel with work on these other initiatives, as long as we allow for refinements in the model structure and data as additional information becomes available. Sensitivity analysis with early versions of the model can be used to help prioritize the need for additional information. In addition, standard modeling or computational engines involving standard representations must be used, and required data in existing information systems must be “capturable.” Critical constraints of modeling for this analysis plan include the lack of knowledge about care paths and results, the lack of baseline comparison data, and problems with determining the sample size be- cause of the large number of care paths. The model would normally be calibrated against a baseline of performance of the system, but it is MACE stands for Military Acute Concussion Evaluation. For more information, see 20 http://www.dbic.org/pdfs/DvBiC_instruction_brochure.pdf (accessed September 29, 2008).

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS not currently clear what the baseline performance is or how one would assess it. Because of the large variety of care paths, many samples of patients with particular combinations of symptoms are too small to be statistically meaningful. Other constraints on the implementation of this plan include (1) acceptance of the model in the military culture, by individuals, and by the public and (2) resource constraints because moderate and severe TBI consume the majority of resources for TBI care and management, leaving few resources for mTBI care. Performance, outcome, and utility metrics would include the input of a population from each of the 48 care program categories; an estimate of patient coverage (the percentage of individuals detected and treated appropriately and the percentage missed); and patient safety outcomes in terms of work-related activities, treatment accessibility (how far patients must travel for treatment), percentage returning to work, and quality of life. Other metrics are the costs and trade-offs of resource requirements (e.g., people, facilities, funding), as well as the people and time required to operate and maintain the model (including collecting data, estimat- ing parameters, and conducting experiments). Overall, the usefulness of this analysis plan is that it could create interactive models capable of generating answers to various questions in only a few months. A necessary task for the execution of this analysis plan is a value- stream analysis for chronic mTBI. Currently, hundreds of soldiers per month “screen” positive for self-reported blast injuries and symptoms, with roughly 50 percent of these diagnosed as symptoms related to mTBI. A value-stream analysis would involve the identification of a cohort of patients with symptoms three months after injury and the tracking of these individuals through the system for three months post- diagnosis by walking with them through the process and understanding what they experience. Then a larger set of patients would be tracked through the MHS information system and surveyed in comparison to all other patients. This would enable researchers to observe what actually happens to patients at each step and to determine the value added of each step in terms of insight and treatment for particular outcomes. The path of each patient would be mapped through the system, with durations and branching frequencies. Completion of the model and essential outputs for users would take about six months. Following the preliminary plan described above, a series of model- ing spirals would have to be defined that would “spiral” through the

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 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE development of process maps for “as is” and “to be” care of patients. A model representation, which would include a disease model showing the progression of mTBI, an organizational model showing how relevant or- ganizations function, and a care management model showing how care is managed by these organizations, would then be selected. Parameters for the model representation would have to be defined, and data require- ments would have to be identified for estimating these parameters. Once the model has been verified and validated through preliminary testing and evaluations, resource-allocation experiments could be performed. The proposed model could be used to inform policy development, respond to congressional inquiries, and identify resource implications for policy changes in terms of people, training, education, and money. In addition, the model could further an understanding of the implications of health quality outcomes, determine optimum allocations of limited resources, and ascertain what is unknown or cannot yet be imagined in relation to emergent behaviors following mTBI. Users of the model would include DOD, Defense Centers of Excellence, MHS, and VA. Outputs of the model would be useful to policy makers, the Govern- ment Accountability Office and Inspector Generals, and authorizers and appropriators. The expected outputs for the proposed model include (1) the iden- tification of processes that need improvement and suggestions for im- proving them; (2) the identification of, and priorities for, processes that should be created; and (3) the identification of critical data that should be collected. Priorities for data collection include information identified through sensitivity analyses, processes that truly impact outcomes, and areas in which exact numbers are needed. Implementation actions include acceptance of the model by DOD and the definition of a course of action, the development of a business case for return on investment of such an initiative, and the elaboration of how current modeling investments could yield much larger future benefits. These benefits would include both longer term returns in reduced workloads and lower costs for MHS and VA health care provid- ers, as well as the shorter term benefits of informed research road maps; analytically defensible investment strategies; credible, compelling risk- management strategies; and prioritized data gathering for high-leverage information. The requirements for this initiative are estimated to be six months for the value-stream analysis, including data collection and direct

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS observation, and an additional six months for each subsequent spiral. The nature of the spirals will depend on the questions that emerge from previous spirals, assuming a collaborative effort and broader coverage of phenomena. Core competencies include proficiency in working with MHS, VA, mTBI, and modeling systems; the value-stream analysis will require contributions from social scientists. The total resources required would equal the value of the person years per month times six months times N + 1, where N represents the number of spirals. SuMMARy The challenges of the TBI workshop from the perspective of OSE are captured in Figure 6-2. Before OSE methods can be brought to bear on TBI care, there must be at least a preliminary understand- ing of the relationships between blast and concussive events and TBIs subject to the conditions of delivery or occurrence and the state of the soldier who is injured. The development of this understanding was addressed by Working Group A in an approach focused on the use of diagnostic and screening tools to establish pre- and post-event baselines, as well as conducting basic research on blast and concus- sive effects. The current MHS TBI care delivery system must be better speci- fied and understood for OSE tools and methods to be used effectively. The complex military health care delivery system includes facilities, medical logistical support, and personnel of the MHS, VA, and civilian health care systems, as well as the families of soldiers suffering from TBI and the soldiers themselves. One of the basic challenges associ- ated with the delivery of care in this system is patient tracking and case management. Working Group C suggested an approach to the development of an information system for tracking, monitoring, and cueing care delivery for all TBI patients. The approach focuses on combining the integra- tion and augmentation of existing databases and a communication system that would ensure access to information and the dissemination of information to appropriate parties; the system architecture would be compatible with the care delivery system. Finally, Group A noted that data available outside the military TBI domain, in the form of records of concussive and other closed-head

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Real World Model World  Improved understanding of effects Identify blast effects on Develop model Assess value brain function for diagnosis of prevention (A) (B) (D) Diagnostic Improved Changes in prevalence methods screening Structure TBI information Improved Evaluate screening Estimate current and Prevalence system and methodology processes future prevalence diagnostic for coordinated care (B) (D) processes (C) Improved screening processes Patient stream Burden of disease Disease history of patient stream Information on Model episode of care Develop database on natural history Develop disease model and allocation of civilian events Impacts on scarce resources (A) (A) disease history (E) Information on effects of treatment Improved treatment processes and associated resource requirements FIguRE 6-2 Interrelationships among suggestions for analysis plans developed by participants in Working Groups A through E. Figure S-1.eps landscape

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS injuries and cases of TBI in the civilian world, could contribute to the development of a more detailed understanding of the course of TBI and the effectiveness of alternative treatments. The group suggested an ap- proach for integrating civilian and military data for use in the military environment. The remaining blocks in Figure 6-2 show typical tasks, largely inter- related, that can be addressed by OSE techniques and methodologies. The development of a quantitative disease model is key to the evaluation of long-term demand for care, strategies for treatment, and the design (and costs) of a high-quality, efficient care delivery system. Working Group A developed an approach to modeling the course of TBI as a finite state-space stochastic process in which patients transition from state to state as a function of additional (non-TBI) trauma, treatment, and the long-term impact of trauma, with co-morbidities impacting the definition and occupancy times of any given state. Group A also developed a plan for using a survey methodology integrated with data mining to support the definition of states, the estimations of transition probabilities, and the distributions of occupancy times. Parameters in the quantitative disease model include diagnosis and screening characteristics, state definitions, and state transitions. Work- ing Group B outlined the development of a series of models that would quantitatively describe and evaluate current practices and then optimize the screening process. The analysis of data through data mining and the execution of surveys would be essential to the development of these models. Markov decision theory, Bayesian networks, influence diagrams, and simulation were cited as viable candidates for evaluating and design- ing TBI diagnostic and screening processes (see Appendix H). To assess the capacity of MHS to treat TBI, one must first under- stand and be able to predict the “demand” on the system. Working Group D described the difficulties of estimating demand, which is complicated because, in many instances, the presence of TBI is not rec- ognized or is not reported promptly in theater and can be missed in post- deployment interviews. The group observed that historical data could be analyzed to develop statistical estimates of the number of mTBIs in the current population of military personnel who have served or are serving in Iraq and Afghanistan. From there, the group outlined a methodology for forecasting future mTBI cases, taking into account conditions in the military theater, threats, and role-based exposures. The group also addressed the challenge of assessing the value of TBI prevention efforts.

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 SyStEmS ENgiNEEriNg to imProvE trAumAtiC BrAiN iNjury CArE The value of specific investments in prevention could be compared us- ing methods of estimating the reduction of TBI incidence as well as the cost savings to the health care system and the reduced burden on soldiers and their families. Given a quantitative disease model and an understanding of the effectiveness, availability, and costs of treatment, it is possible to design and evaluate care delivery from the perspective of individual patients, a patient population, and the entire health care enterprise. Working Group E designed an approach to the development of an enterprise-level health care delivery model with the goal of addressing, quantitatively, a broad spectrum of TBI treatment capacity, organizational and resource allocation issues to support decisions on policy, and design of the health care enterprise. The suggestions for analysis plans developed by the five working groups indicate how OSE methods and tools could contribute to meet- ing the challenges of delivering effective, efficient, high-quality TBI care and management. Particular quantitative methods and models could provide insights into the design of diagnostic and screening processes, the delivery of care, the sizing of facilities, and the design of the overall health care delivery complex to meet current and future demands. As depicted in Figure 6-2, the challenges addressed by the OSE analysis plans are interrelated with the outputs of each analysis plan potentially providing important inputs to the development of one or more of the other plans. Collectively these illustrative plans address many of the TBI stakeholder issues identified during the planning phase of the workshop (Appendix B). The suggestions and assumptions of the working groups identified underlying cross-cutting dependencies important to the development and application of OSE methods and tools to TBI care: • an assumption that sufficient reliable data are available for the development of useful initial versions of all of the plans suggested by the working groups and that additional reliable data could be generated to improve and refine these approaches and provide more comprehensive and precise support to meet MHS needs • a recognition of the need for standardized, detailed coding to record TBI symptoms, injuries, and (possibly) treatments more accurately

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 SuggEStioNS for ANAlySiS PlANS By WorkiNg grouPS • the importance of data sharing and interoperability of data bases relevant to TBI diagnosis, treatment, measurement, and prediction • the need for more extensive, detailed maps of care paths and pro- cesses and associated information, patient, provider, and material flows for TBI care within the MHS The ideas and concepts introduced during the workshop may be helpful to DOD leaders working to refine and improve DOD’s system of health care delivery, both at the individual patient-provider level and at the enterprise level. Applications of OSE concepts, tools, and methods have the potential to contribute to improvements in care, not only for TBI patients but for all patients cared for by MHS. REFERENCES Cope, D.N., N.H. Mayer, and L. Cervelli. 2005. Development of systems of care for persons with traumatic brain injury. Journal of Health Trauma Rehabilitation. Focus on Clinical Research and Practice 20(2): 128–142. DVBIC Working Group (Defense and Veterans Brain Injury Center Working Group on the Acute Management of Mild Traumatic Brain Injury in Military Operational Settings). 2006. Clinical Practice Guideline and Recommendations 22 December 06. Available online at http://dbic.org/public_html/pdfs/clinical_practice_guideline_recommendations. pdf (accessed August 7, 2008). Guler, I., A. Tunca, and E. Gulbandilar. 2008. Detection of traumatic brain injuries using fuzzy logic algorithm. Expert Systems Applications 34(2): 1312–1317. Labutta, R.J. 2008. Medical Aspects of Traumatic Brain Injury (TBI). Presentation at the Workshop on Harnessing Operational Systems Engineering to Improve Traumatic Brain Injury Care in the Military Health System, National Academies, Washington, D.C. June 11, 2008. Sayer, N. 2006. Department of Veterans Affairs Quality Enhancement Research Initiative. 2006 Strategic Plan. Available online at http://www.hsrd.minneapolis.med.a.go/pdf/ Pt_Strategic Plan.pdf (accessed September 29, 2008).

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