Vanderploeg, Rodney D. PhD; Belanger, Heather G. PhD
Section Editor(s): Sander, Angelle M. PhD
SINCE OCTOBER 2001, there have been more than 1.5 million separated Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn (OEF/OIF/OND) Veterans. Of these, approximately 805 000 (∼54%) have obtained healthcare through the Veterans Health Administration (VHA).1 Many have had multiple deployments. As a result of increased awareness of deployment-related traumas and postdeployment healthcare concerns, both the Departments of Defense (DoD) and VHA have developed innovative approaches to identify, assess, and treat military personnel involved in these conflicts. The focus in this commentary is on screening procedures for identification of possible deployment-related traumatic brain injury (TBI) (similar procedures are also in place for posttraumatic stress disorder, depression, and alcohol abuse, among other symptoms and problems).*
BACKGROUND: VHA AND DoD SCREENING PRACTICES FOR MILD TBI
The VHA, to ensure identification of service members potentially needing medical services following deployment to Iraq or Afghanistan, implemented a series of OEF/OIF/OND clinical reminders (ie, mandated clinical questions to ask the Veteran, prompted by the electronic medical record). A TBI Clinical Reminder was incorporated into the system in April 2007. These Clinical Reminders are completed by any provider within the VHA system of care who first encounters that patient, most frequently a primary care provider.
The VHA TBI Clinical Reminder is essentially a population screen for TBI, particularly mild TBI. It is completed if the Veteran served in Iraq or Afghanistan after September 11, 2001. It consists of 4 questions regarding: (1) injury event, (2) immediate loss or alteration of consciousness, (3) immediate/acute postconcussive symptoms, and (4) current (past week) postconcussive symptoms. A positive response to all 4 questions constitutes a positive screen. From this process, it should be apparent that the goal of the screen was to identify individuals who may have experienced a deployment-related TBI and who currently are reporting symptoms that may be related to that historically remote injury event. Positive screens automatically generate a consult to a TBI specialist or specialty clinic if the Veteran agrees to further assessment or care. This specialist/clinic has 1 week to initiate contact with the patient to schedule a more detailed follow-up evaluation.
The DoD has its own postdeployment screens incorporated into the Post-Deployment Health Assessment (PDHA) and Reassessment (PDHRA) programs. The PDHA is scheduled with trained healthcare providers within 30 days after returning home or to a military processing station. The purpose is to review each Service Member's current health, mental health, and psychosocial issues commonly associated with deployments, as well as possible deployment-related occupational and environmental exposures. A screen for TBI, similar to the VHA's screen, was incorporated into the PDHA in 2008. Positive responses require supplemental assessment and/or referrals for medical consultation. Also in 2008, a rescreening for TBI was added to the PDHRA, which should be completed 90 to 180 days following deployment. The TBI rescreening was removed from the PDHRA in September 2012 but remains in the PDHA.
In both VHA and DoD healthcare systems, TBI screens are positive between 15% and 23% of the time.2–4 Within the VHA, clinicians have completed a subsequent Comprehensive TBI Evaluation on 75% of the positive screens (the rest fail to return for scheduled appointments or cannot be contacted). Of these, a TBI is confirmed 56% of the time (ie, 44% false negatives). The VHA's TBI screen, as used in typical clinical care nationally, is 87% sensitive but only 15% specific.5 One study conducted in a research context using carefully trained examiners, readministered the TBI Clinical Reminder screen and subsequently completed a structured clinical interview as the criterion standard for TBI.6 This study found 94% sensitivity and 59% specificity, which might be thought of as reflecting the high end of sensitivity and specificity under ideal conditions.
PRINCIPLES OF MEDICAL SCREENING
Model and core principles
In medical practice, screening for a disorder or condition is a strategy used within a population of interest to identify an unrecognized condition. Screening is designed to identify a disease, condition, or risk factor early, thus enabling earlier intervention and management in the hope of reducing mortality and suffering. Figure 1 illustrates this medical screening model. Therefore, a medical screening is designed for progressive disorders (eg, cancer, hypertension, early heart disease)7,8 or disorders with very poor potential outcomes that are preventable (eg, blood screens during pregnancy to check for red blood cell antibodies). For example, if a cancerous tumor in the breast is diagnosed early or an enlarged prostate gland is detected before it becomes cancerous, the hope is that appropriate early treatment will prevent problems from developing later. Wilson and Jungner8 outlined 10 principles of useful medical screening (see Table 1).
Streiner summarized these principles in 2 main points: (1) that the natural history of the disorder is that these previously undetected problems will in fact become major ones if untreated and (2) that a treatment exists and is effective.7(p215) However, a third crucial principle is that a suitable test exists to confirm the suspected diagnosis if screening is positive. If these 3 conditions are not met, screening programs may do more harm than good.
Risks of screening
It is important to recognize that although screening may lead to an earlier diagnosis, not all screening programs have been shown to benefit the person being screened. Overdiagnosis, misdiagnosis, and creating adverse iatrogenic effects are some potential adverse effects of screening, in addition to unnecessary costs. Screening always results in some degree of false-positive responses, which, in turn, tend to result in (a) unnecessary tests and procedures, (b) anxiety and fears in the patient/family, and (c) potentially iatrogenic worsening of symptoms that are unrelated to the screened condition but tied to the “false screen” in the mind of providers and patients.
For example, after reviewing years of research and examining benefits and harms, recent recommendations have been put forth reversing longstanding screening practices using the prostate-specific antigen (PSA) test for prostate cancer. The PSA test was originally approved by the Food and Drug Administration in 1986 to monitor the progression of prostate cancer in men who had already have a diagnosis of the disease. In 1994, the Food and Drug Administration approved the use of the PSA test to screen asymptomatic men for prostate cancer. Since then until very recently, many doctors and professional organizations encouraged yearly PSA screening for men beginning at age 50. However, the rate of false-positive PSA screens is around 12% to 13%.9 Given the base rates of prostate cancer (about 17% of men in the United States will receive the diagnosis of prostate cancer in their lifetime), most men with an elevated PSA level turn out not to have prostate cancer. In fact, only about 25% of men who have a prostate biopsy following a positive PSA screen actually have prostate cancer.10
In 2011, the US Preventive Services Task Force (USPSTF) reviewed the literature and found evidence that the PSA screening process itself produces harm, including pain and discomfort associated with prostate biopsy and adverse psychological effects of false-positive test results. In addition, it found convincing evidence that treatment of prostate cancer detected by screening caused moderate to substantial harm, such as erectile dysfunction, urinary incontinence, bowel dysfunction, and death. These harms were seen as especially important because many men with prostate cancer who are treated would never have developed symptoms related to cancer during their lifetime.9 As a result, in 2012, the USPSTF recommended against PSA-based screening of men in the general US population, regardless of age.11
COMPLICATIONS IN SCREENING FOR MILD TBI
TBI is not a progressive disorder
Medical screening is generally done for early disease detection, typically of progressive disorders. In the realm of screening for mild TBI, a basic core criterion for screening is missing—TBI is not a progressive disorder. A TBI reflects an acute injury that typically improves with time. Deficits from a TBI may not completely resolve, but they are not expected to worsen over time, with the exceptions of acute medical complications such as subdural or epidural hematomas or subarachnoid bleeding, neither of which are relevant to VHA/DoD screenings. Treatment of injuries, including TBIs, are begun and often completed in the acute or post–acute phase. In the chronic phase, those who sustained a prior moderate to severe TBI (a) have noticeable difficulties without screening, (b) can typically accurately report a history of TBI, (c) have someone else who accompanies them report this information, or (d) have evidence of TBI documented in their medical records. Therefore, screening for moderate to severe TBI really is not needed.
As a result, it is really only for mild TBIs (ie, concussions) that screening is advocated or practiced. However, with mild TBI, screening is always going to be remote in time from the injury event. When presented with an acute concussion or mild TBI, medical providers do an assessment of the nature and extent of the injury, and if the evaluation is positive for a concussion, then acute concussion management is initiated. Acute concussion management is designed to ensure that any possible medical complications such as subdural or epidural hematomas or subarachnoid bleeding are identified and treated, if necessary, and to avoid the possibility of a second impact syndrome. However, following acute concussion management, what is the “natural history” of mild TBI?
By definition and based on diagnostic criteria, mild TBIs/concussions result in some initial brief loss or alteration of consciousness. Mild cognitive impairments, particularly mental processing speed and efficiency, attention/concentration, and memory difficulties are common in the initial hours after a mild TBI and not uncommon in the initial days or weeks postinjury. However, by 30 or fewer days after a mild TBI, cognitive functioning has returned to normal.12–14 Similarly, most individuals experience 1 or more postconcussive symptoms (eg, headaches, fatigue) immediately after their mild TBI. However, the sports concussion literature suggests that cognitive and symptom recovery occur rapidly and generally in parallel after injury.15
Our own work has found an association between a remote history of mild TBI and increased levels of current postconcussion-like symptoms.16–18 For example, in a Florida National Guard sample, those who sustained a deployment-related mild TBI were 2.5 times more likely to have a collection of postconcussion symptoms 31.8 months later compared to those without a history of mild TBI, even after controlling for other adverse experiences associated with combat and deployment, including blast exposure and other injuries. However, these same symptoms were 2.6 times higher in those who had other types of physical injuries during deployment and 3.1 times higher in those who were exposed to heavy combat experiences.18 Therefore, it is unknown whether mild TBI had any unique and direct causative effect for these symptoms or whether these deployment-related factors represent a common stress or injurious effect.
Nonetheless, this work and that of others indicate that a minority of those who sustained a mild TBI complain of various cognitive, psychological, and physical difficulties months and even years after injury, which they and healthcare providers sometimes attribute to mild TBI. Most of these postconcussion symptoms are indistinguishable from the diffuse, nonspecific symptoms experienced by many normal healthy individuals and symptoms that are at increased rates following periods of stress such as military combat situations. Although it is clear that several individuals have symptoms months and even years following a concussion, the available longitudinal literature indicates that these symptoms are unlikely to be related to the mild TBI19,20 and that the natural course is recovery.13,21 In a groundbreaking longitudinal study, symptoms were found to be unrelated to mild TBI and, instead, were associated with accompanying acute posttraumatic stress and depressive or anxiety disorders.21 Importantly, symptoms that presented acutely generally did not persist and not infrequently new symptoms appeared at follow-up.
Reliable confirmation of a TBI diagnosis after a positive screen is currently not possible
There is no definitive way to diagnose mild TBI in the post–acute or chronic phase. Reliance on self-report via a structured interview is the criterion standard but is fraught with difficulty. Potential monetary and psychological “rewards” complicate matters. Unlike physical diseases that have biological markers (eg, tumor cells, blood pathogens), mild TBI, though, clearly a physical injury, must be witnessed for verification and may even then be misdiagnosed. Neuroimaging in the emergency department is frequently normal,22 and in fact some definitions of mild TBI preclude neuroimaging abnormalities. Screening for a condition that inspires disagreement about its definition, and for which reliable diagnosis is virtually impossible, is ill advised.
Within VHA, the Comprehensive TBI Evaluation following a positive TBI screen is designed in part to confirm the diagnosis. Across facilities one would expect similar rates of TBI confirmation, given that all those evaluated begin with exactly the same positive screen. However, rates of confirmation vary from 19% to 93% (this includes only those sites who have completed more than 100 Comprehensive TBI Evaluations).23 Even among the 5 Polytrauma Rehabilitation Centers, which are seen as the centers of excellence, the TBI confirmation rates following a positive screen range from 50% to 76%. These figures should not be surprising, given that no reliable TBI confirmatory diagnostic test or procedure currently exists.
Effective treatment should exist for screened disorders, but no treatment exists for chronic mild TBI
Another major requirement for screening is that if a disorder or condition is identified, appropriate and effective treatment should exist for that condition.8 Given the natural history of mild TBI, if postconcussion-like symptoms exist in the chronic phase, they are most likely unrelated to mild TBI/concussion and far more likely to be related to other factors, particularly mental health conditions.21,24 The only demonstrated effective treatment is for acute mild TBI and that treatment is early psychoeducational and supportive interventions.
We have extensively reviewed the literature on nonpharmacological approaches to the treatment of postconcussive symptoms.25 Psychoeducational interventions for mild TBI include giving patients information about common symptoms following concussion, typical time course of symptoms, expectancy effects, relation of symptoms to stress, and strategies for symptom management and reattribution. These educational interventions in the acute phase have been shown to result in significantly shorter average symptom duration and significantly fewer symptoms at follow-up in civilians.26–28 Expectation management is key, using appropriate support, education, early symptom management, and a clear and consistent positive message of recovery over time.
However, as the existing literature is almost entirely civilian seen within days to weeks after injury, it is still unknown whether Veterans with combat-related mild TBI seen months to years postinjury and postcombat can benefit from this type of intervention. Without an evidence-based treatment, screening for chronic TBI is contraindicated.
Harms and costs outweigh benefits of mild TBI screening
A growing body of literature demonstrates the role of expectation in both cognitive performance and rate of symptom complaint. Simply drawing attention to the label “TBI” can cause increased symptom reporting and result in poorer cognitive performance.29–32 If there is an expectation of postinjury problems, then, in at least some individuals, such symptoms are more likely to be reported.30,33 In addition, since virtually everyone with a mild TBI experiences acute symptoms for minutes to hours, the mere presence of these symptoms can reinforce preexisting negative expectations and beliefs. Unfortunately, recent media attention has reported on concussions in the sports arena and in the military and associated mild TBI and multiple concussions with subsequent chronic traumatic encephalopathy, dementia, suicide, and other adverse long-term outcomes. As a result, it is understandable that both patients and providers may have somewhat catastrophic reactions to a positive screen for TBI.
In contrast, if there is no expectation of ongoing symptoms, then few or no ongoing symptoms are reported.29 Both brain dysfunction and expectation play independent and interactive causative roles.34 Given the current political climate, emphasis on TBI as the “signature injury” of the war on terror, and misinformed media attention on mild TBI leading to chronic traumatic encephalopathy, research regarding patient self-expectation is particularly pertinent. Merely by screening individuals within the context of increased societal attention on TBI, the stage is set for expectancies to exert an adverse influence on the patient's belief system with resulting increase in symptoms experienced and misattribution of many normal symptoms such as headaches, fatigue, and everyday memory slips to TBI. In addition, there may be an inclination by the patient to misattribute symptoms to TBI, rather than to treatable psychological conditions such as posttraumatic stress disorder and depression, given the perception that a physical brain injury is less “their fault” or under their control. Indeed, the structure and sequence of the screening questions, which combine the definition of mild TBI with acute and current symptoms, creates the impression that the mild TBI caused the symptoms.
In addition to the role of expectation, the screening process necessarily will inflate reporting. That is, patients who are not really troubled by their “symptoms” report them when asked during screening and subsequently undergo further evaluation for them. Research has clearly demonstrated that left to their own devices (or spontaneous report), people report far fewer symptoms than when queried in a more structured manner.35 Therefore, not only does a screening and evaluation process for mild TBI create some negative expectations but it may also create “problems” where none existed.
There is also the consideration of financial cost. While the screen itself is embedded in a variety of other postdeployment screens and therefore is of minimal additional cost, the subsequent evaluation and treatment process adds considerable cost. Because of the high sensitivity and low specificity of the screen,6 significant clinical resources are spent ruling out numerous false positives (44%). By screening all patients, even those who would not have otherwise presented at a clinic, and with a high false-positive rate, the system bears significant unnecessary costs. In addition, extra “cost” is likely created by TBI screening and medical evaluation-induced iatrogenesis noted earlier in the form of unnecessary treatments, healthcare visits, and lost work by patients. Because only 38.6% of those who screen positive for mild TBI receive a definitive diagnosis of TBI, screening for mild TBI is arguably quite a wasteful process. Importantly, more than 95% of veterans evaluated for TBI use VHA services after the evaluation, and those diagnosed with TBI used significantly more outpatient care.36 Whether that care actually resulted in better outcomes is unknown.
In addition, there is the cost to the larger Veterans Affairs system and to society in terms of disability compensation. In 2008, the Veterans Benefits Administration created a disability category for residuals of TBI that allows for assignment of up to 40% disability to those who report 3 or more subjective symptoms that interfere at least moderately with work, instrumental activities of daily living, or important social relationships. On the basis of our analyses of the VHA national data, approximately 70% of veterans screening positive for mild TBI report at least 3 symptoms at a level indicating moderate day-to-day functional impairment or worse during the Comprehensive TBI Evaluation following a positive screen. If disability benefits were provided on the basis of the level of medical symptom reporting during the Comprehensive TBI Evaluation, this would be a substantial cost to the system, given the high endorsement rate of symptoms.
The VHA and DoD are to be commended for attempting to make sure that Service Members and Veterans returning from deployment are offered whatever medical care they require. The benefit of postdeployment screening (TBI and other health and mental health screens) is to identify and treat problems (regardless of etiology one might argue). Given that the primary focus of the TBI screen is on nonspecific symptoms, and given the unknown etiology of these symptoms, a problem-centric, symptom-based approach is likely most prudent. Such an approach is laid out in the VA/DoD Clinical Practice Guidelines for concussion/mild TBI.37 Primary care or postdeployment clinics are well suited and equipped to identify and treat or triage such troubling symptoms of unknown etiology.
In reviewing potential benefits and costs/harms of screening for mild TBI, as shown in Table 2, the potential costs/harms outnumber the potential benefits. Furthermore, some of the benefits assume that the underlying conditions of useful screening, as reviewed earlier, have been met (eg, that mild TBI is a progressive condition and that proactive treatment is a good thing because effective treatment exists). Unfortunately, as has already been illustrated, these assumptions for screening are not met with regard to screening for mild TBI.
SUMMARY AND RECOMMENDATIONS
On the basis of generally accepted medical screening principles and assumptions, screening for mild TBI is unnecessary at best and potentially harmful at worst. The conditions for beneficial medical screening—progressive disease, symptoms related to the identified disease, suitable tests or examinations for accurate diagnosis, and accepted and effective treatment—are simply not met. Because nonspecific postconcussion-like symptoms can be effectively treated in a symptom specific manner, tying them to concussion (which in the chronic phase is highly unlikely) through a screening and evaluation process is wasteful and potentially harmful. This is not to say that screening for other high probability postdeployment conditions such as depression, posttraumatic stress disorder, or substance use disorders may not be beneficial. However, the same type of medical screening criteria and harm/cost/benefit analyses should be undertaken to ensure that such screening programs are likely to be effective and beneficial.
In order to assure that patients with significant subjective functionally impairing problems continue to be identified and referred for appropriate care, symptom and behaviorally-based post-deployment healthcare screens, not directly tied to diagnostic disorders, could be implemented. As now, these positive screens could then be referred for follow-up evaluations and treatment in post-deployment primary care clinics or polytrauma clinic settings, depending upon the nature of the positive symptom complaints. Screens would identify problems associated with chronic deployment stress and post-deployment adjustment, rather than unconfirmed diagnostic conditions. Nonspecific postconcussive-like symptoms could be effectively treated in a symptom-specific manner, rather than incorrectly tying them to concussion.
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37. Department of Veterans Affairs and Department of Defense. VA/DOD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury. Vol 2009:. Washington, DC: Department of Veterans Affairs and Department of Defense; 2009; .
*The first author of this commentary was part of the workgroup that developed the screening questions and procedures for VHA TBI screening.Cited Here...