PREFACE

The VA Evidence-based Synthesis Program (ESP) was established in 2007 to provide timely and accurate syntheses of targeted healthcare topics of particular importance to clinicians, managers, and policymakers as they work to improve the health and healthcare of Veterans. QUERI provides funding for four ESP Centers, and each Center has an active University affiliation. Center Directors are recognized leaders in the field of evidence synthesis with close ties to the AHRQ Evidence-based Practice Centers. The ESP is governed by a Steering Committee comprised of participants from VHA Policy, Program, and Operations Offices, VISN leadership, field-based investigators, and others as designated appropriate by QUERI/HSR&D.

The ESP Centers generate evidence syntheses on important clinical practice topics. These reports help:

• Develop clinical policies informed by evidence;
• Implement effective services to improve patient outcomes and to support VA clinical practice guidelines and performance measures; and
• Set the direction for future research to address gaps in clinical knowledge.

The ESP disseminates these reports throughout VA and in the published literature; some evidence syntheses have informed the clinical guidelines of large professional organizations.

The ESP Coordinating Center (ESP CC), located in Portland, Oregon, was created in 2009 to expand the capacity of QUERI/HSR&D and is charged with oversight of national ESP program operations, program development and evaluation, and dissemination efforts. The ESP CC establishes standard operating procedures for the production of evidence synthesis reports; facilitates a national topic nomination, prioritization, and selection process; manages the research portfolio of each Center; facilitates editorial review processes; ensures methodological consistency and quality of products; produces “rapid response evidence briefs” at the request of VHA senior leadership; collaborates with HSR&D Center for Information Dissemination and Education Resources (CIDER) to develop a national dissemination strategy for all ESP products; and interfaces with stakeholders to effectively engage the program.

Comments on this evidence report are welcome and can be sent to Nicole Floyd, ESP CC Program Manager, at vog.av@dyolF.elociN.

EXECUTIVE SUMMARY

Falls are a common cause of injury among elderly populations, particularly those residing in nursing homes. Most falls in nursing homes occur at the ground level and are low impact. Injuries resulting from these types of falls are variable and range from serious orthopedic and head injury requiring transport to an emergency department (ED) or trauma center to mild injury that can be managed with closer short-term monitoring by nursing staff.¹ The American Medical Directors Association (AMDA) Clinical Practice Guideline recommends that facilities have written policies to guide fall management including initial patient evaluation, monitoring for signs of delayed injuries, determination of the circumstances of the fall, and mitigation of risk factors for future falls.²

Initial patient evaluation after falls involves conducting a physical exam to evaluate the extent of injuries, including impaired consciousness as measured by the Glasgow Coma Scale (GCS), and considering baseline risk factors for intracranial hemorrhage, a potential complication of head injury. Identifying patients with moderate-severe injuries in need of transport and head imaging is usually straightforward. However, determining which patients with mild injuries need further evaluation can be more challenging as many elderly patients have pre-existing dementia or other cognitive disorders that impair the physical exam and GCS assessment, as well as higher baseline risk for intracranial hemorrhage due to use of anticoagulants. A further challenge in evaluating patients with possible head injury after falls is that a subset of patients who initially have a normal exam will develop delayed intracranial hemorrhage and could worsen quickly. For these reasons, guidelines on management of mild head injury including those by the American College of Emergency Physicians/Centers for Disease Control and Prevention commonly recommend head computed tomography (CT) for all patients ≥ 65 years old, even with a normal GCS.³

Despite these guidelines, excessive use of CT and implications for patient safety remains a concern due to radiation exposure.⁴ While the exact rate of normal CT scan findings in nursing home patients presenting after falls is unknown, most patients evaluated for head injury in the ED have normal CTs. A retrospective study using data from the National Hospital Ambulatory Medical Care Survey in the US found that 91% of the approximately 3.9 million head CTs obtained in ED patients to evaluate for head injury in 2009-2010 did not reveal a traumatic intracranial abnormality.⁵

Near infrared spectroscopy (NIRS) is a diagnostic tool that could be used to evaluate patients after falls and aid in decision-making to avoid unnecessary CTs. NIRS is an imaging technique that identifies intracranial hematomas by detecting asymmetry in light absorption over the right and left sides of the head. Handheld NIRS devices offer a portable, noninvasive, and quick means of evaluating patients for the presence of a brain hematoma. Infrascanner© 2000 is the only commercially available NIRS device in the US and is currently being used by clinical staff at the VA Pittsburgh's Community Living Center (CLC) to evaluate patients with mild injuries after falls when the clinical suspicion for head injury is low. The aim of this evidence brief was to evaluate the potential impact of NIRS as a diagnostic test for hematomas in nursing home patients after falls by synthesizing the evidence on the performance characteristics of NIRS for detecting brain hematoma, its impact on clinical decision-making, patient outcomes, potential harms, and cost-effectiveness.

Ideally, NIRS use would reduce unnecessary CTs and ED visits among nursing home patients who have mild injuries. This potential benefit must be weighed against the potential harm of a negative NIRS scan in a patient who truly has a brain hematoma in need of further intervention. In general, NIRS is not well-suited to identify bilateral hematomas, small hematomas, and deeply located hematomas with a greater distance from the scalp. Some hematomas that would not be detected by NIRS, but would be identified by CT, are unlikely to cause symptoms or a further change in patient's function. Other small hematomas could expand over time, causing symptoms and functional decline, and these hematomas would be important not to miss. In addition to the potential for missing a clinically important hematoma, there could be other unintended consequences of NIRS use. For example, fewer ED transfers could place additional strain on nursing home staff due to the need to monitor patients more frequently. Fewer ED transfers could also represent missed opportunities to identify reasons for patient falls if they do not undergo more extensive testing. The ideal study of NIRS would aim to capture not only the false positive rate, but these other potential harms.

Unfortunately, studies of NIRS to date have almost exclusively focused on demonstrating the technical feasibility of the device and its diagnostic accuracy in series of patients who are referred for a CT scan. These studies therefore provide little insight on how use of NIRS impacts clinical decision-making, patient outcomes, and healthcare utilization. Moreover, it is unknown how NIRS performs in older nursing home patients with mild injury after falls because this type of use has not been studied. Only one study of Infranscanner© 2000 has been conducted in patients with mostly mild injuries, and in that observational study of 85 patients presenting to a neurosurgical center with predominantly mild head injury (85% with GCS 12-15), Infrascanner© 2000 failed to identify 2 hematomas among 43 patients with hematomas on CT.⁶ Patients had a mean age of 48, high prevalence of hematomas (53%), and unreported baseline risk factors. The findings of this study are not necessarily predictive of how NIRS would perform in nursing homes with a different makeup of patients and overall lower prevalence of hematomas.

Given concerns about overuse of CT and the potential benefits of NIRS as a diagnostic tool in nursing home patients with mild injuries after falls, it would be reasonable to consider implementation of a NIRS protocol in a pilot study among VA CLCs. A pilot could provide reliable estimates of CTs and ED transfers averted. However, because positive CT scans are rare in this situation, a much larger study (or decision modeling) would be needed to assess the frequency and clinical consequences of false negative NIRS scans.

INTRODUCTION

METHODS

To identify articles relevant to the key questions, our research associate searched MEDLINE®, Cochrane Database of Systematic reviews, Cochrane Central Register of Controlled Trials, PsycINFO, Health Technology Assessment, Database of Abstracts of Reviews of Effects, NHS Economic Evaluation Database, CINAHL, Military & Government Collection, and Scopus up to 6/30/2017, using terms for hematoma, hemorrhage, brain injury, near infrared, and spectroscopy; additional citations were identified from grey literature sources, hand-searching reference lists, and consultation with content experts (see Supplemental Materials Appendix A for complete search strategies). We limited the search to published and indexed articles involving human subjects available in the English language. We also contacted Infrascan, Inc. and BYTech Inc. with requests for scientific information. Study selection was based on eligibility criteria described above. Titles, abstracts, and full-text articles were sequentially reviewed by 2 investigators and checked by a third. All disagreements were resolved by consensus.

We used predefined criteria to rate the internal validity of all included studies. We used the Cochrane ROBIS tool to rate the internal validity of systematic reviews.²¹ We used QUADAS-2 tool to rate the internal validity of diagnostic accuracy studies.²² We abstracted data from all studies for prespecified study and patient characteristics of interest and results for each included outcome. For studies that did not report NIRS performance characteristics, we calculated sensitivity, specificity, PPV, and NPV when data on NIRS and CT results were available. For studies that reported NIRS performance characteristics for a subset of hematoma types, we performed additional calculations for all hematoma types when possible. All data abstraction and internal validity ratings were sequentially reviewed by 2 investigators and checked by a third. All disagreements were resolved by consensus.

We graded the strength of the evidence for Infrascanner© 2000 and Crainscan© (the 2 NIRS handheld devices that are currently commercially available) sensitivity and specificity based on the AHRQ Methods Guide for Comparative Effectiveness Reviews.²³ This approach incorporates 4 key domains: risk of bias (includes study design and aggregate quality), consistency, directness, and precision of the evidence. It also considers other optional domains that may be relevant for some scenarios, such as a dose-response association, plausible confounding that would decrease the observed effect, strength of association (magnitude of effect), and publication bias. Strength of evidence is graded for each key outcome measure and ratings range from high to insufficient, reflecting our confidence that the evidence reflects the true effect.

Where studies were appropriately homogenous, we synthesized outcome data quantitatively Microsoft® Excel® for Windows (2016) to estimate pooled effects. Where meta-analysis was not suitable due to limited data or heterogeneity, we synthesized the evidence qualitatively.

A draft version of this report was reviewed by technical experts selected to represent relevant specialties including radiology, NIRS device development, and systematic review methodology. Their comments and our responses are available in Appendix F in the supplemental materials.

The complete description of our full methods can be found on the PROSPERO international prospective register of systematic reviews (http://www.crd.york.ac.uk/PROSPERO/; registration number CRD42017071444).

RESULTS

The literature flow diagram (Figure 1) summarizes the results of the search and study selection processes.

LITERATURE FLOW

Figure 1Literature Flowchart

LITERATURE OVERVIEW

Searches resulted in 797 unique potentially relevant articles. We included 12 observational diagnostic accuracy studies (see Supplemental Materials Appendix B for list of excluded studies),^{6,14,18,20,24-31} with a median sample size of 89 (range 19-365) and a total population of 1,364 individuals. We identified a 2017 systematic review by Brogan et al¹⁶ that included 8 diagnostic accuracy studies on NIRS. Brogan et al¹⁶ included only 6 (50%) of the studies included in our review.^{14,18,20,26,29,30} Notably, the review by Brogan et. al.¹⁶ did not include the newest studies of Infrascanner© 2000^6,31 and Infrascanner© 1000²⁴ that were published after their search end date of 1/1/2015. Also, the review by Brogan et al¹⁶ included 2 additional studies in pediatric populations^32,33 that were outside our scope. We received a scientific information packet from Infrascan, Inc. which did not include studies that we had not otherwise identified in our search.

Table 1 presents the characteristics of the 12 primary studies (see Supplemental Materials Appendix C for full evidence tables). Mean patient age for all studies was ≤ 60 years old. Most studies (67%) did not report on gender, but those that did included 51-83% male patients. Although skin and hair color are potential confounders of the NIRS signal, most studies (67%) did not report this information. Most patients had a history of TBI or suspected TBI and had been referred for CT scan. In Hennes et al,²⁸ patients were already diagnosed with a subdural hematoma and in Kahraman et al,²⁹ patients were already diagnosed with an epidural or subdural hematoma.^28,29 2 studies included a control population of healthy individuals or those with minor injuries.^6,29 Aside from Hennes et al,²⁸ which only included patients with diagnosed hematomas, the prevalence of any type of hematoma ranged from 5-59%.

Table 1

Characteristics of Included Studies.

Severity of signs and symptoms at presentation was reported in 50% of studies. In 5 of the 6 studies that reported severity measures at presentation, most patients had a GCS score close to or ≥ 13, consistent with mild injury.^{6,14,20,24,30} In contrast, patients included in Peters et al³¹ had a mean GCS of 6.9, consistent with severe injury.

Studies varied in the type of handheld NIRS device used. Six studied used Infrascanner© 1000 or 2000 and 2 additional studies used the RunMan device. ^{6,14,20,24,25,27,28,31}Three studies used Crainscan© or Smartscan.^26,29,30 One study used a device developed by the study authors.¹⁸

No studies were conducted in elderly nursing homes patients with low clinical suspicion for hematoma after a fall. Only one study was conducted in the US (multicenter study conducted in the US and India by Robertson et al¹⁴). Most studies (83%) occurred in the emergency department or hospital setting. One study was conducted in the pre-hospital setting.³¹ Most studies (83%) were single-center.

Risk of bias was unclear in the majority of studies (67%) due to uncertainty regarding how patient selection was conducted and whether radiologists interpreting CTs were blinded to NIRS results. Risk of bias was low in the remainder of studies. Figure 2 shows the details of the risk of bias assessment.

Figure 2

Summary of QUADAS-2 Assessment.

KQ1. What are the performance characteristics of NIRS as a diagnostic test for patients suspected of having a brain hematoma or with risk factors for brain hematoma?

Performance characteristics are shown by study in Table 2 and by device in Figures 3 and 4 (see Supplemental Materials Appendices D and E for full details). 2 studies of Infrascanner© 2000,^4,5 have the most practical application because Infrascanner© 2000 is the only commercially available NIRS handheld device in the US. In patients with predominantly mild TBI referred to a neurosurgery center, Infrascanner© 2000 correctly identified hematomas in 96% of patients (sensitivity) and correctly ruled out hematomas in 93% (specificity).⁶ Infrascanner© 2000 failed to identify 2 hematomas among 43 patients with hematomas on CT scans (false negatives).⁶ But, given that patients in this study had a mean age of 48, high prevalence of hematomas (53%), and unreported baseline risk factors, findings of this study are not necessarily predictive of how NIRS would perform in nursing homes with a different makeup of patients and overall lower prevalence of hematomas. When used in patients with predominantly mild TBI, CrainScan©³⁰ and Infrascanner© 1000^14,20,24 correctly identified and ruled out hematomas at rates ranging from 68% to 89% (sensitivity) and 67% to 95% (specificity), respectively. NIRS' accuracy in correctly identifying and ruling out hematomas also ranged widely in patients with severe TBI³¹ and when used in patients already diagnosed with hematoma²⁸. Collectively, these findings provide little insight on how NIRS would perform in elderly nursing home patients with mild injuries.

Table 2

Performance Characteristics.

Figure 3

NIRS Sensitivity by Device.

Figure 4

NIRS Specificity by Device.

Across studies, reasons cited for false negatives included bilateral hematomas, small hematomas below the NIRS detection threshold, deeply located hematomas with greater distance from the scalp, patient agitation or motion, and difficulty completing NIRS examination in transport.^{14,18,20,27-31}

SUMMARY AND CLINICAL IMPLICATIONS

We found no studies that evaluated the use of NIRS among nursing home patients after falls to avoid unnecessary CTs. Instead, studies of NIRS have almost exclusively focused on demonstrating the technical feasibility of the device and its performance characteristics, providing little insight on how the use of NIRS impacts clinical decision-making, patient outcomes, and healthcare utilization. Moreover, studies of NIRS have mostly been in patients ≤60 years old in the ED or hospital setting, with largely unreported disease severity and baseline risk factors for intracranial hemorrhage, thereby limiting applicability of findings to older patients in nursing homes.

Given that the nominator's highest priority was to evaluate the clinical impact of NIRS in nursing home patients after falls, we acknowledge that we excluded studies on the development of NIRS as a diagnostic test that were not designed to evaluate NIRS performance characteristics or other clinical outcomes. While the earliest studies of NIRS have value in terms of understanding the principles of NIRS and how NIRS measurements (change in optical density) compare to CT findings, studies that did not define when a NIRS scan was considered positive or negative (ie, state a cut-off point for the change in optical density that indicates a positive scan) or report performance characteristics have lower clinical relevance.

Early studies^34-38 on RunMan are examples in which the authors did not state how they defined a positive NIRS scan, thereby limiting the conclusions that can be drawn from these studies about the performance characteristics of NIRS as a diagnostic test. Given more time, we could request and analyze raw individual patient data from these studies^34-38 to derive additional sensitivity and specificity data based on published detection thresholds for Crainscan/Smartscan and Infrascanner. However, additional data on performance characteristics would still not address the most significant limitation of the current literature base – the lack of outcomes related to the impact of NIRS on clinical decision-making and healthcare utilization including use of CT.

We also acknowledge that we excluded studies^35-38 evaluating the use of serial NIRS scans in hospitalized TBI patients in order to detect late-onset hematomas. However, using serial NIRS to monitor patients who are hospitalized for head injury and/or have already been diagnosed with a hematoma or undergone surgery is a distinct clinical scenario with different reference tests (such as intracranial pressure monitoring) that has limited applicability to the nominator's priority population.

Potential harms of NIRS as a test for hematomas in nursing home patients after falls are primarily related to the possibility of obtaining a negative NIRS scan in a patient who truly has a hematoma in need of further intervention. Across studies, reasons cited for false negative results reflect known limitations of NIRS as an imaging technique. In general, currently available NIRS devices are not well-suited to identify bilateral hematomas, small hematomas, and deeply located hematomas with a greater distance from the scalp. It is unknown how many patients could be harmed by a false negative NIRS scan if NIRS is used to evaluate nursing home patients with mild injury after falls. Some small hematomas that would not be detected by NIRS, but would be identified by CT, are unlikely to cause symptoms or a further change in patient's function. Other small hematomas could expand over time causing symptoms and functional decline, and these hematomas would be important not to miss. In addition, there could be unintended consequences of fewer ED transfers, including strain on nursing home staff due to more frequent monitoring of patients as well as missed opportunities to identify reasons for patient falls if they do not undergo more extensive testing in the ED.

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Brogan RJ, Kontojannis V, Garara B, Marcus HJ, Wilson MH. Near-infrared spectroscopy (NIRS) to detect traumatic intracranial haematoma: A systematic review and meta-analysis. Brain Inj. 2017;31(5):581-588. [PubMed: 28440675]

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Infrascanner - White Paper: A Handheld Brain Hematoma Detector. In: Inc. I, ed2014.

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Francis SV, Ravindran G, Visvanathan K, Ganapathy K. Screening for unilateral intracranial abnormalities using near infrared spectroscopy: a preliminary report. J Clin Neurosci. 2005;12(3):291-295. [PubMed: 15851084]

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Akyol PY, Bayram B, Acerer A, et al. Comparison of near-infrared spectroscopy and head CT interpretations of the ED patients with minor head injury. Am J Emerg Med. 2016;34(8):1364-1368. [PubMed: 27133531]

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Ghalenoui H, Saidi H, Azar M, Yahyavi ST, Borghei Razavi H, Khalatbari M. Near-infrared laser spectroscopy as a screening tool for detecting hematoma in patients with head trauma. Prehospital Disaster Med. 2008;23(6):558-561. [PubMed: 19557974]

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Appendix A. Search Strategies

Appendix A. Search Strategies (PDF, 58K)

Appendix B. List of Excluded Studies

Appendix B. List of Excluded Studies (PDF, 49K)

Appendix C. Evidence Tables

Appendix C. Evidence Tables (PDF, 84K)

Appendix D. Forest Plots

Appendix D. Forest Plots (PDF, 72K)

Appendix E. Performance Characteristics

Appendix E. Performance Characteristics (PDF, 18K)

Appendix F. Peer Review

Appendix F. Peer Review (PDF, 36K)

REFERENCES Supplemental Materials

1.

Akyol PY, Bayram B, Acerer A, et al. Comparison of near-infrared spectroscopy and head ct interpretations of the ed patients with minor head injury. Am J Emerg Med. 2016 Aug;34(8):1364–1368. [PubMed: 27133531]

2.

Coskun F, Sezer EA, Karamercan MA, Akinci E, Vural K. An assessment on the use of infrascanner for the diagnosis of the brain hemotoma by using support vector machine. Scientific Research and Essays. 2010;5(14):1911–1915.

3.

Francis SV, Ravindran G, Visvanathan K, Ganapathy K. Screening for unilateral intracranial abnormalities using near infrared spectroscopy: A preliminary report. J Clin Neurosci. 2005 Apr;12(3):291–295. [PubMed: 15851084]

4.

Ghalenoui H, Saidi H, Azar M, Yahyavi ST, Borghei Razavi H, Khalatbari M. Near-infrared laser spectroscopy as a screening tool for detecting hematoma in patients with head trauma. Prehospital Disaster Med. 2008 Nov-Dec;23(6):558–561. [PubMed: 19557974]

5.

Hennes HJ, Lott C, Windirsch M, et al. Non invasive detection of intracerebral hemorrhage using near infrared spectroscopy (nirs). SPIE. 1997;3194:42–54.

6.

Hennes HJ, Richter B, Lott C, Dick W, Boor S, Hanley DF. Follow-up in patients with subdural haematomas using near infrared spectroscopy (nirs). Proc SPIE Int Soc Opt Eng. 1999;3566:182-192.

7.

Kahraman S, Kayali H, Atabey C, Acar F, Gocmen S. The accuracy of near-infrared spectroscopy in detection of subdural and epidural hematomas. J Trauma. 2006 Dec;61(6):1480–1483. [PubMed: 17159695]

8.

Kessel B, Jeroukhimov I, Ashkenazi I, et al. Early detection of life-threatening intracranial haemorrhage using a portable near-infrared spectroscopy device. Injury. 2007 Sep;38(9):1065–1068. [PubMed: 17716603]

9.

Leon-Carrion J, Dominguez-Roldan JM, Leon-Dominguez U, Murillo-Cabezas F. The infrascanner, a handheld device for screening in situ for the presence of brain haematomas. Brain Inj. 2010;24(10):1193–1201. [PubMed: 20715889]

10.

Peters J, Van Wageningen B, Hoogerwerf N, Tan E. Near-infrared spectroscopy: A promising prehospital tool for management of traumatic brain injury. Prehospital Disaster Med. 2017:1-5. [PubMed: 28351447]

11.

Robertson CS, Zager EL, Narayan RK, et al. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. Journal of Neurotrauma. 2010 Sep;27(9):1597–1604. [PubMed: 20568959]

12.

Xu L, Tao X, Liu W, et al. Portable near-infrared rapid detection of intracranial hemorrhage in chinese population. J Clin Neurosci. 2017:26. [PubMed: 28279553]

13.

Brogan RJ, Kontojannis V, Garara B, Marcus HJ, Wilson MH. Near-infrared spectroscopy (nirs) to detect traumatic intracranial haematoma: A systematic review and meta-analysis. Brain Inj. 2017;31(5):581–588. [PubMed: 28440675]

Prepared for: Department of Veterans Affairs, Veterans Health Administration, Quality Enhancement Research Initiative, Health Services Research & Development Service, Washington, DC 20420.

Prepared by: Evidence-based Synthesis Program (ESP), Coordinating Center, Portland VA Health Care System, Portland, OR, Mark Helfand, MD, MPH, MS, Director.

Recommended citation: Mackey K, Peterson K, Bourne D, Anderson J, Boundy E, Helfand M. Evidence Brief: Near Infrared Spectroscopy for Detecting Brain Hematoma. VA ESP Project #09-199; 2017.

This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Coordinating Center located at the Portland VA Health Care System, Portland, OR, funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative. The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of the Department of Veterans Affairs or the United States government. Therefore, no statement in this article should be construed as an official position of the Department of Veterans Affairs. No investigators have any affiliations or financial involvement (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in the report.