SPECIAL CONTRIBUTIONS
Trauma Registries: History, Logistics, Limitations, and Contributions to Emergency Medicine Research Shahriar Zehtabchi, MD, Daniel K. Nishijima, MD, MAS, Mary Pat McKay, MD, and N. Clay Mann, PhD, MS
Abstract Trauma registries have been designed to serve a number of purposes, including quality improvement, injury prevention, clinical research, and policy development. Since their inception over 30 years ago, there are increasingly more institutions with trauma registries, many of which submit data to a national trauma registry. The goal of this review is to describe the history, logistics, and characteristics of trauma registries and their contribution to emergency medicine and trauma research. Discussed in this review are the limitations of trauma registries, such as variability in quality and type of the collected data, absence of data pertaining to long-term and functional outcomes, prehospital information, and complications as well as other methodologic obstacles limiting the utility of registry data in clinical and epidemiologic research. ACADEMIC EMERGENCY MEDICINE 2011; 18:637–643 ª 2011 by the Society for Academic Emergency Medicine
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y definition, a registry is a uniform set of information that is generated in a systematic and comprehensive manner to serve a predetermined purpose.1 In health care, disease-specific registries have been used to serve a number of purposes, including quality improvement, epidemiology, clinical and outcomes research, and policy development.2 The development of trauma registries coincided with introduction of trauma centers and systems in the United States in the 1970s.3 Early trauma registries were institution-based and generally lacked uniformity. The primary goal of these early registries was to document the epidemiology of traumatic conditions.4 In 1982, the American College of Surgeons Committee on Trauma (ACS-COT) coordinated the Major Trauma Outcome Study (MTOS), From the Department of Emergency Medicine, Downstate Medical Center and Kings County Hospital (SZ), Brooklyn, NY; the Department of Emergency Medicine, University of California at Davis (DKN), Sacramento, CA; the Department of Emergency Medicine, George Washington University Hospital (MPM), Washington, DC; and the University of Utah School of Medicine, Intermountain Injury Control Research Center (NCM), Salt Lake City, UT. Received September 14, 2010; revision received December 21, 2010; accepted December 23, 2010. The authors have no relevant financial information or potential conflicts of interest to disclose. Supervising Editor: Craig D. Newgard, MD, MPH. Address for correspondence and reprints: Shahriar Zehtabchi, MD; e-mail:
[email protected].
ª 2011 by the Society for Academic Emergency Medicine doi: 10.1111/j.1553-2712.2011.01083.x
which collected 5 years of trauma data from 139 North American hospitals and over 80,000 injured patients.5 The primary objective of this study was to develop a national reference standard for trauma care that could be used by hospitals for quality assurance. Stemming from the success of the MTOS, the ACSCOT established the National Trauma Data Bank (NTDB).6 The goal of this national registry was to continue and broaden the work of the MTOS. Since its inception in 1994, many researchers have published work based on data from the NTDB. In 2008, the NTDB implemented the National Trauma Data Standard (NTDS) to standardize data collection across all reporting hospitals. Currently, the NTDB contains detailed data on over 2.7 million cases from over 900 U.S. trauma centers.6 Internationally, a number of developed countries maintain population-based national trauma registries including Germany (Trauma Registry of the German Society for Trauma Surgery),7 Australia and New Zealand (National Trauma Registry Consortium), and Canada (National Trauma Registry).3 Although developing countries face a number of barriers to the development of trauma registries,8 a few countries have succeeded in developing regional registries that provide outcome9 and injury prevention data.10 LOGISTICS OF A TRAUMA REGISTRY The following elements play key roles in the creation of a trauma registry: 1) collected variables, 2) inclusion and exclusion criteria, 3) registry software, 4) registry
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staff and training, and 5) data cleaning strategies. Understanding the components of a trauma registry is critical, whether one is developing a trauma registry for an institution or using registry data for research or administrative purposes. There are no general and all-inclusive guidelines for developing each of the trauma registry elements. Currently each institution designs its trauma registry based on its needs or to meet mandatory state or city requirements. Attempts to create universal criteria for all trauma registries will eliminate one of the hurdles that currently limit optimal use of them. The NTDS provides definitions for variables and response codes. Institutional and state trauma registries often collect additional variables depending on their needs. Most trauma registries incorporate the following data: demographic information, mechanism of injury (external cause of injury codes), procedures, clinical diagnoses (based on International Statistical Classification of Diseases and Related Health Problems, ninth edition [ICD-9]), length of stay, disposition, and in-hospital mortality. Many also include abbreviated injury scores (AIS), charges, payers, and information about complications and follow-up procedures if they occur at the same institution. Some important variables, such as longer-term mortality or functional outcomes, are rarely collected. This remains as one of the major weaknesses of trauma registries. Each trauma registry has a set of inclusion and exclusion criteria. The NTDS defines trauma based on the ICD-9 code (from 800 to 959.9, but excluding ICD-9 codes associated with late effects of injury and insignificant injuries such as blisters, abrasions, insect bites), plus trauma-related hospital transfer by emergency medical services (EMS), hospital admission, or death.6 There is significant variability between both institutional and statewide trauma registries in the inclusion of prehospital and field or ED deaths, patients who are discharged from the ED, and patients with isolated hip fractures.11 Among statewide registries, the highest variability was observed in regard to inclusion of injuries other than blunt or penetrating trauma cases, such as drowning, suffocation, electrocution, or burns.11 Maintaining an organized and accurate trauma registry requires well-trained staff with sufficient time for registry upkeep. Institutions with large trauma volumes often hire trauma registrars dedicated to the maintenance of the trauma registries. Other trauma registries are managed by trauma nurse coordinators who have both clinical and trauma registry responsibilities. At all levels, maintenance of a reliable registry is very costly. While statewide trauma registries often have funding through state or federal agencies, the economic burden is often unilaterally borne by the individual institution. Thus the quality of data at the institutional level may be subject to the institution’s ability to sufficiently allocate funding to maintain registry infrastructure. Trauma registrars collect, encode, and enter data about patient demographics, pre- and in-hospital care, diagnoses, procedures, and complications. Diagnoses and procedures are coded using ICD coding, and disease severity is often coded using the AIS code.12 These data are extracted manually from the medical
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record and radiology reports. Despite the complexity of data management required by trauma registrars, there is currently no mandatory educational or certification process. While most registrars do undergo some training, the majority are not certified ICD or AIS coders, even though it is possible to become certified in both.12 As a result, previous studies have shown the coding accuracy of registries to be poor,13,14 especially for the sickest patients.15 Errors at data collection and data entry levels can lead to incorrect information and skew study results. While missing data are inevitable in collecting large amounts of retrospective data, availability of mechanisms to identify and fix these errors are important to improve the quality of the data set. To ensure data completeness, the NTDB requires a number of essential fields to be present for inclusion of a patient record into the database. Despite recommendations for data standardization, there is still significant variability in data points among institutions. For example, statewide registries employ different strategies to estimate the commonly missing information regarding the time of injury. To code the time of injury, some registries use dispatch time for EMS; others use 5, 10, 15, or 20 minutes before the EMS dispatch time; some have chosen EMS dispatch time only in case of motor vehicle collisions; and some use the time of EMS arrival to the ED as the indicator of the time of injury.11 OBJECTIVES Trauma registries are intended to enable users to: 1) assess and improve patient care; 2) identify opportunities for injury prevention initiatives; 3) document the medical, economic, and social effects of trauma; and 4) develop and test research hypotheses. Assess and Improve Patient Care Registry data can be used as a quality control tool for comparing trauma care practices in any institution with national or international standards. Most of the published studies addressing the effectiveness of trauma systems in North America employ trauma registries for their analyses. We identified two separate systematic reviews that have examined the effectiveness of the trauma system. Jurkovich and Mock16 compiled 11 significant studies, published between 1987 and 1997, which analyzed the effectiveness of trauma systems using trauma registries. Authors included studies that either compared institutions with and without integrated trauma systems or compared the data from a single institution before and after implementation of such a system. Most of these studies supported the effectiveness of trauma systems. However, the authors did note poor methodology limiting the quality of the included studies.16 In another systematic review, Mann et al.17 found reduced mortality in severely injured patients with established trauma systems, compared to centers where no trauma system existed. However, the absence of prehospital data, short-term survival data, and functional outcome data in most of the identified studies
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prevented the authors of this review from making strong conclusions on effectiveness of trauma systems.17 In a large study involving 31 academic Level I and Level II trauma centers across the United States, Nathens et al.18 evaluated the association between trauma center volume and outcomes of trauma patients. This study demonstrated a strong association between trauma center volume and outcomes, with significant improvements in mortality and length of hospital stay when volume exceeds 650 cases per year. These benefits were only evident in patients at high risk for adverse outcomes.18 Identify Opportunities for Injury Prevention Initiatives Trauma registries may be used to address several aspects of injury prevention. Whether they describe events at a single institution, in a city, in a region, in a state, or within an entire country, they can be readily used to describe the mechanisms and circumstances responsible for the injuries. Naturally, understanding the scope of the problem is the first step toward addressing it. Such information can be used at local, state, or regional levels to advocate for interventions aiming at reducing the risk of similar injuries, such as changing playground surfaces, motorcycle helmet use, and limiting the legal blood alcohol level for driving motor vehicles.19–21 Collected over time, these data can also be used to document the effectiveness of legislation implemented to prevent admissions or changing mortality and morbidity over time—and describe the data far more completely than hospital billing records.22 Trauma registries differ from hospital billing records in that they include physiological data such as triage vital signs, more complete injury severity coding than can be obtained from just ICD-9 codes, and more specific clinical details about procedures and interventions. When combined with accurate crash information, such as evaluations performed by the Crash Injury Research and Engineering Network (CIREN),23 the details can provide information that improves the trauma triage of future patients.24 Because trauma resuscitations are resource-intensive, accurate trauma triage is particularly important in the current era of emergency department overcrowding. The Centers for Disease Control and Prevention (CDC) recently started an initiative to reinforce the profound importance of on-scene triage decisions made by EMS providers. This ‘‘National Trauma Triage Protocol’’ educational initiative has been developed to be the foundation for the development, implementation, and evaluation of local and regional field triage protocols. By using the information provided in this initiative, EMS professionals can play an active role in improving the health outcomes of injured persons in their communities.25 Although useful for injury prevention and improving trauma triage, there are several issues associated with the type of data and quality of the data within most trauma registries. Currently, trauma registries routinely collect only information about the index admission. This
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limits their utility; they only assess fatality up to the time when the patient is discharged from the index visit, and death related to the index injury may occur up to 1 year later.26 When it comes to injury prevention, an accurate description of what ‘‘life is like’’ after the injury may be more useful in encouraging the use of preventive devices (e.g., shin guards, helmets, safety belts) than telling people, ‘‘you could die.’’ Studies documenting the full short- and long-term social and psychological outcomes after injury can provide invaluable information, but the data collection for such studies is expensive and difficult.27,28 Among the greatest issues with using trauma registry data to describe injury epidemiology is the accuracy and reliability of the data itself as described above. In addition, trauma registries tend to systematically exclude those injured patients who die before reaching the hospital. Therefore, to achieve population-based statistics, the information extracted from the trauma registries must be combined with an outside source that contains the missing prehospital data.29 The fact that institutions use different entry criteria affects the completeness of regional or larger sets that combine institutional data. This has been shown to skew the results of data analysis, particularly in regard to injury severity.2,30 Prehospital and outcome data (e.g., rehabilitation or neurologic function) often are collected in databases separate from in-hospital data. Linking these databases to a single injury event remains a challenge for analyzing injury patterns and injury outcomes. Privacy laws, such as the Health Insurance Portability and Accountability Act (HIPAA), often prevent the storage of patient identifiers (e.g., medical record number, name, date of birth) thus limiting the ability to easily combine databases. Probabilistic linkage is a technique that uses available data such as sex, age, date of event, and zip code to calculate linkage likelihood and probability weights.31 This allows for the linkage of records between data sets when one or more sets of data do not have personal identifiers. However, even with probabilistic linkage, there is often incomplete matching of databases. Last, one of the main criticisms of trauma registries by injury control experts is that registries remain passive repositories of a large amount of injury data that play little active and timely role in injury surveillance work and decisions. Surveillance is an epidemiologic practice by which the spread of disease is monitored in order to establish patterns of progression. Trauma registries should serve as a source of surveillance in order to predict, observe, and minimize the harm caused by injuries, as well as increase our knowledge as to what factors might contribute to such circumstances. Develop and Test Research Hypotheses One of the main objectives of creating trauma registries is to develop and test research hypotheses. A significant number of trauma-related studies published in the United States and other countries obtain their subjects, entirely or in part, from local, statewide, or national registry databases.32 The ability to capture large numbers of patients in registries provides researchers the
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ability to evaluate rare conditions such as massive transfusion,33 traumatic coagulopathy,34 and traumarelated venous thromboembolic disease.35 Some registry-driven studies initiated by emergency physicians have had significant impact on our knowledge of trauma outcomes. For example, a large registry-based study by Wang et al.36 revealed greater mortality and neurologic impairment in patients with traumatic brain injury if they were intubated in the field rather than in the ED. Unfortunately, trauma registries are poised with variations in data entry, missing or uncollected vital data, or lack of standardization, which collectively limit their use for research purposes. It must be noted that trauma care is a multidisciplinary subject and related to many specialties including emergency medicine. Most studies addressing trauma-related issues are directly relevant to the practice of emergency medicine and therefore need to be viewed with scrutiny and vigilance. Deficiencies of Data Collection. Perhaps the most troublesome problems with registries originate from lack of documentation of factors that might account for the observed differences in outcomes, such as resource utilization, morbidity, or mortality. Key examples of such factors influencing outcome in trauma patients but unrelated to injury severity are preexisting comorbid conditions such as severe liver disease, coagulopathy, renal insufficiency, poorly controlled diabetes, and severe cardiac disease. Although the use of comorbidity indices (e.g., the Charlson comorbidity index37) can be used in conjunction with trauma registry data to assess their effect on outcomes, there are nearly limitless other factors not recorded in registries that may or may not influence outcome.38 Collecting and recording prehospital events remains one of the most difficult challenges of trauma registries. Inconsistency in recording some critical information such as Glasgow Coma Scale (GCS) score in the field, and field vital signs, prevents researchers from incorporating this valuable information into their investigations.38 Accurate chronologic documentation of field events requires consistency as well. This consistency has a direct bearing on the evaluation of response, scene, and transport times. Fortunately, some researchers have developed imputation techniques to handle missing data from the registries.39 Using these techniques might help with analyzing the registry information by reducing the risk of impact of missing data. Finally, most investigators believe that complications are underreported in trauma registries. Rates of complications within the NTDB are astonishingly low, especially when compared with other databases such as the National Surgical Quality Improvement Program (NSQIP) General Surgery Group, which represents a reference cohort of largely elective operative cases. For example, in the NTDB (2009) data, only 3,954 of 627,684 cases had systemic sepsis. This corresponds to a sepsis rate of 0.6% in the trauma patient population. At the same time, the NSQIP General Surgery Group at University of Michigan (UM) had a rate of 3.1% for sepsis.40 A recent study of electronic alerts to prevent venous thromboembolism among hospitalized patients
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demonstrated a rate of 5.1% for thromboembolism within 90 days after admission to the hospital.41 This correlates well with 6.5% rate of such events in trauma patients enrolled in UM NSQIP. However, the thromboembolism rate discovered in the NTDB for trauma patients admitted in 2009 was only 0.7% (4,674 of 627,684).6,40 Unfortunately, most centers do not have the infrastructure to track and document complications as they emerge. Specifically, the manual registrar-based data collection process does not readily allow most institutions to identify their complications systematically.40 Underreporting the complications and inability to calculate the prevalence of complications and risks renders the studies proposing new therapeutic modalities for various trauma populations inaccurate and practically worthless. For example, a recent evidence-based review evaluating the effect of transfusion of fresh frozen plasma in a 1:1 ratio to packed red blood cell transfusion on mortality of severely injured trauma patients revealed that most of the included studies relied on trauma registry data and reported in-hospital mortality rates.42 Few studies reported the rate of sepsis, single- or multiorgan failure, nosocomial infections, or acute respiratory distress syndrome in their study subjects.42 Discrepancies in reporting the complication and long-term mortality rates among studies generate conflicting results. Clearly, confusing and conflicting results lack the ability to have any meaningful impact on clinical practice. In summary, the absence of important components of trauma care, such as prehospital deaths and complication rates, as well as the failure to incorporate measures of long-term survival and functional outcomes among those who survive, limits the utility of trauma registries in assessing the current effectiveness of care and testing new therapeutic measures.17,38,40 Variability of Definitions and Lack of Standardization. Different institutions define key registry variables differently—a reality that may not be obvious once data is combined. For instance, the definition of ‘‘length of stay’’ or ‘‘length of intensive care unit stay’’ may be calculated in whole numbers (a ‘‘day’’ as a full 24 hours or any portion thereof) or in hours or fractions of a day. The time of disposition may be defined as either the time of the physician’s order to transfer the patient or as the time when the patient has physically moved. Data collection of operative and procedural interventions is also not standardized. Some institutions record all invasive procedures, including diagnostic peritoneal lavage, intracranial monitoring, and diagnostic testing, while others only document surgical interventions. As a result of some of these discrepancies, Owen et al.43 observed major differences in hospital length of stay for patients with similar injuries among 14 facilities. Validity and Quality of Registry Data. The Trauma Resource Network, an official program of the National Foundation for Trauma Care, specifies that managing the trauma registry is a large part of the trauma service’s function and highlights that this management should include validation and quality control of the trauma registry data. ACS-COT emphasizes the
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importance of valid data entry, monitoring data validity, and establishing protocols for internal validation to detect errors in data entry or coding.44 Errors generally occur as a result of missing entries, mistakes in transcribing or coding (false-positive, falsenegative, inconsistent, or incongruent coding), duplicate entries, redundant data unnecessarily introduced for certain selected patients (commission errors), or suppositious data temporarily substituting for unknown variables (errors in demographics).32 Errors because of incorrect entries will result in invalid numbers and frequencies, which, in turn, renders invalid estimated parameters and rates. In the NTDB report for 2003, about 25% of the 731,824 records were excluded from statistical analysis because of errors of inconsistency or invalid records of age, sex, or hospital length of stay.40,44 In the reference manual for the same report, data entry error rates for unknown or missing information for hospital transfers, external causes of injury, and admission GCS values were 76, 34, and 19%, respectively. These errors, together with the absence of standardization and uniformity of information collection, complicate the appropriate application of trauma registries and limit their usefulness in comparing data between registries.16,17,40,45 These issues indicate an undeniable need for establishing appropriate validation protocols for all trauma registry centers. Unfortunately, few published studies report any measure to control the quality of the data used. Sampling Method. The sampling method for studies derived from trauma registries is a convenience sampling, even though some research articles may claim otherwise.46 Most states have legislation that mandates reporting of data to statewide trauma registries.11 However, there is significant variability among states in regard to the types of hospitals that are required to submit to state registries. Some states collect data only from designated trauma centers, while other states expect data from all acute care facilities.11 Moreover, variability in inclusion and exclusion criteria among centers excludes the possibility of a continuous sample of the population. In a convenience sample, not every member of the target population has an equal opportunity to be selected. These ‘‘left-out’’ subjects might have behaved differently from the included subjects. Convenience sampling of a nonhomogenous trauma population limits the generalizability and validity of the results. Therefore, the findings of such studies are never definitive. Trauma registry studies are also susceptible to a variety of sampling-related biases, including spectrum bias, membership bias, detection bias, diagnostic workup bias, nonsimultaneous comparison bias, attrition bias, and sample size bias. Exploring the details of such biases is beyond the scope of this article. Study Designs. In general, trauma registry–based studies are considered retrospective. In some centers, some information such as age, sex, mechanism of injury, and laboratory or imaging results are collected prospectively. Completion of the data required for any given study most likely will entail some paper or electronic chart review. In addition, it is important to note
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that the definition of prospective study does not refer to the forward-going nature of the data collection only. It rather requires generation of the research question before the start of the data collection. Keeping this fact in mind, trauma registry studies, especially the ones that involve chart reviews, must adhere to the standard methodology protocols required for collecting and reporting the results of retrospective studies to ensure accuracy and minimize inconsistencies.47 Such protocols should include adequate training of the data abstractors before and during the data collection (frequent refreshing training), using explicit criteria for inclusion and exclusion of cases, precise definition of variables, creating and utilizing standardized data collection forms, organizing frequent meetings with data abstractors to solve problems and resolve disputes, constant monitoring of the data abstraction process, blinding of the data abstractors to the hypothesis that is being tested, and testing and reporting the interrater agreement for all or part of the collected data.47 Last, most registry-based studies are designed to address a particular research question after the data are already collected (i.e., ad hoc hypothesis). Therefore, they are not comparable in validity of results to studies that define their research questions a priori. Other Potential Benefits of Trauma Registries. The use of trauma registries to perform cost-effectiveness analysis of various trauma care practices is largely unexplored. Only a few published studies have used the registries for such a purpose. Two notable studies enjoyed high practice-changing impact by supporting the cost-effectiveness of strategies that already had been proposed by evidence: using computed tomographic scanning for complete cervical spine evaluation48 and nonoperative management of splenic injuries.49 In a third study, Orsay et al.50 exposed the financial burden of motorcycle riders who did not use helmets by analyzing the data from the trauma registry of the state of Illinois. CONCLUSIONS Trauma registries are valuable sources of information that could potentially be used in quality of care improvement, policy development, injury prevention, and clinical and epidemiologic research for a variety of specialties, including emergency medicine. However, far more work is required to improve the quality and type of the data entered in the registries, especially in regard to standardization of terms and definitions, inclusion and exclusion criteria, and inclusion of prehospital information, long-term morbidity and mortality, and complication rates. Until the deficiencies of trauma registries are addressed by multidisciplinary interventions, interpreting the results of the studies derived from these databases warrants caution. References 1. Brooks E. The Current and Future Use of Registries in Health Information Systems. Geneva: World Health Organization, 1974.
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