Keywords
traumatic brain injury - registry - data collection
Introduction
In this new millennium, noncommunicable diseases are rapidly growing in the developing
world including India adding to the existing burden of communicable diseases.[1]
[2] Injuries have been accepted as major cause of mortality, morbidities, and disabilities
with uncountable downstream economic loss.[3]
[4] Yet, injury care in India is at a nascent stage of development and a nationwide
survey encompassing various facilities has documented significant deficiencies in
current trauma management systems.[3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14] Accurate data are needed to evaluate clinical outcomes, therapeutic modalities,
and quality of care in trauma.[15] Reliable estimates of the burden of road traffic injuries are an essential input
for rational priority setting and a national estimate of the burden of injuries should
be built by collating information from all existing information sources by appropriately
correcting for source-specific shortcomings.[2]
[16] The available data in India have severe limitations as injury surveillance system
needs reliable, accurate, and adequate data to improve road safety interventions.[17] The present study was conducted to identify the core variables to collect data on
the demographics, clinical course, management, and outcome of traumatic brain injuries
(TBIs) and to develop an electronic data entry interface (including web-based data
entry interface) in a resource-limited setting.
Materials and Methods
The current study is an exploratory study performed at the Narayana Medical College
& Hospital, Nellore, Andhra Pradesh, India. Prospective data collection was done for
all the diagnosed cases of TBI admitted during the study period (July 2014–December
2014), using a predesigned and pretested questionnaire. The data were collected in
a predesigned pro forma and all efforts were made to complete the questionnaire to
maintain the uniformity and reproducibility. The details of TBI pilot study questionnaire
and data collection procedure (which included emergency assessment, patient characterization,
preclinical data, emergency room intervention details, intensive care unit [ICU] management
details, diagnosis, and follow-up) have been described in our previous studies.[9]
[10]
[11]
[12]
[18]
[19]
[20] Several variables are identified as an essential component for any trauma registry
(TR) such as age, gender, residence, district hospital; date and time of injury and
arrival; Glasgow coma scale score for head injuries (TBIs)[21]; category (blunt, burn, and penetrating); mechanism of injury; intent of trauma;
pre-existing conditions; vital signs on arrival (blood pressure, heart rate, and respiratory
rate); optimum investigations including roentgenogram, computed tomography (CT), laboratory
tests, or ultrasound; procedures performed; date of first surgery; length of stay;
discharge status (alive or dead); and Glasgow outcome scale[22] were included in the pro forma (Supplementary Appendix I and Supplementary Appendix II [online only]).[23]
[24]
[25]
[26]
[27] The data were collected by trained nursing personnel under the supervision of emergency
and neurosurgery consultants. Based on paper-based pro forma, simultaneously, electronic
data entry interface was developed in FileMaker Pro Advanced 13 (Copyright 1994–2015,
FileMaker, Inc; Santa Clara, California, United States) and Web-based data entry interface
was developed using Drupal CMS (http://neuropractices.com/content/tbi-registry). This helped in on-screen display, easy data entry, and proved useful in maintaining
uniformity especially in case of data collection from multiple centers. The web-based
data entry interface has restricted access and can only be accessible to registered
uses. All the measures were taken to mask the identity of the patients. Permission
from institutional ethics committee was sought for carrying out the study. Written
informed consent was collected from the patients in compliance with regulations and
guidelines following Helsinki declaration if they were conscious at the time of data
collection. In other cases, legally authorized representatives were approached for
consent, viz., from next of kin, or in case of minors or patients unable to give consent.
Statistical Analysis
A common analysis and reporting plan was prepared and analysis of data was done using
StatsDirect version 3.0.150 (StatsDirect statistical software, StatsDirect Ltd., Cheshire,
WA, England; 2015; http://www.statsdirect.com), generating simple frequencies for nonnumeric variables and simple averages for
numeric variables.
Results
A total of 402 patients were included in the study. Mean age was 37.34 ± 16.08 years
(male 78.11% and female 21.89%), majority was illiterate (46.52%) ([Table 1]). Loss of consciousness (73.88%) with or without vomiting (48.51%) followed by bleeding
from ear (39.55%) and nose (32.84%) was the common clinical presentations; rhinorrhea
was not noted in this pilot study. In the analysis of body regions involved along
with TBI, it was noted that injuries to the extremities (17.16%) were the most important
comorbidities. However, injury to pelvic girdle was not associated with any of the
cases in this series. In the conservative management apart from tetanus toxoid (70.90%),
urinary catheter (61.69%) was the commonest intervention followed by administration
of colloid (59.95%) and crystalloid (37.06%); 13.18% cases were put on ventilation;
blood transfusion was needed by only two cases. Based on ICD-10, traumatic cerebral
edema was the commonest diagnosis (35.32%) followed by concussion (30.10%) and traumatic
subdural hemorrhage (18.66%) ([Table 2]). After detail analysis, a revised variable list was obtained (Supplementary Appendix I [online only]) and a revised paper pro forma and electronic data interface were designed
(Supplementary Appendix II [online only]). In addition to the previously described variables, many other variables
are proposed to be added to the further study which include handedness (right/left/ambidexterity),
primary caregiver—responsible for earning in family,[24]
[27] management-related variables (hypothermia therapy, nutrition replacement, hyperventilation
therapy, and seizure prophylaxis), and details of complications (hypotension episode,
hypoxia episode, any infections, and deep vein thrombosis).[23]
[24]
[25]
[26] Disability rating scale was being added to make data collection and follow-up more
objective and comparable.[28]
Table 1
Details of educational and employment status of the patients who sustained traumatic
brain injury
|
Education and employment status
|
Frequency
|
%
|
|
Illiterate
|
187
|
46.5
|
|
Farmer
|
102
|
25.4
|
|
Primary
|
29
|
7.2
|
|
Unknown
|
14
|
3.5
|
|
House wife
|
12
|
3
|
|
Student
|
8
|
2
|
|
Employee in service
|
3
|
0.7
|
|
Unemployed
|
8
|
2
|
|
Self-employee
|
9
|
2.2
|
|
Retired employee
|
3
|
0.7
|
|
Graduate
|
3
|
0.7
|
|
Laborer
|
2
|
0.5
|
|
Secondary
|
11
|
2.7
|
|
Postgraduate
|
2
|
0.5
|
|
Total
|
393
|
97.8
|
|
Missing system
|
9
|
2.2
|
|
Total
|
402
|
100
|
Table 2
Details of clinical presentation, body regions involved, conservative management,
and diagnosis (ICD-10) as a dichotomous variable
|
Clinical presentation
|
Yes
|
%
|
No
|
%
|
|
Loss of consciousness
|
297
|
73.88
|
105
|
26.12
|
|
Vomiting
|
195
|
48.51
|
207
|
51.49
|
|
Nausea
|
13
|
3.23
|
389
|
96.77
|
|
Ear bleed
|
159
|
39.55
|
243
|
60.45
|
|
Nasal bleed
|
132
|
32.84
|
270
|
67.16
|
|
Oral bleed
|
57
|
14.18
|
345
|
85.82
|
|
Headache
|
59
|
14.68
|
343
|
85.32
|
|
Seizures
|
29
|
7.21
|
373
|
92.79
|
|
Rhinorrhea
|
0
|
0.00
|
402
|
100.00
|
|
Otorrhea
|
5
|
1.24
|
397
|
98.76
|
|
Posttraumatic amnesia
|
22
|
5.47
|
380
|
94.53
|
|
Details of body regions involved
|
|
Head
|
402
|
100.00
|
0
|
0.00
|
|
Neck
|
11
|
2.74
|
391
|
97.26
|
|
Thorax
|
5
|
1.24
|
397
|
98.76
|
|
Chest
|
16
|
3.98
|
386
|
96.02
|
|
Abdomen
|
1
|
0.25
|
401
|
99.75
|
|
Pelvic girdle
|
0
|
0.00
|
402
|
100.00
|
|
Extremities
|
69
|
17.16
|
333
|
82.84
|
|
Pelvic contents
|
0
|
0.00
|
402
|
100.00
|
|
Cervical spine body region
|
2
|
0.50
|
400
|
99.50
|
|
Thoracic spine body region
|
2
|
0.50
|
400
|
99.50
|
|
Lumbar spine body region
|
1
|
0.25
|
401
|
99.75
|
|
Details of conservative management
|
|
Urinary catheter
|
248
|
61.69
|
154
|
38.31
|
|
Nasogastric tube
|
78
|
19.40
|
324
|
80.60
|
|
Tetanus toxoid
|
285
|
70.90
|
117
|
29.10
|
|
Crystalloid
|
149
|
37.06
|
253
|
62.94
|
|
Colloid
|
241
|
59.95
|
161
|
40.05
|
|
Blood transfusion
|
2
|
0.50
|
400
|
99.50
|
|
Cervical collar
|
16
|
3.98
|
386
|
96.02
|
|
Cervical traction
|
1
|
0.25
|
401
|
99.75
|
|
Bed rest
|
320
|
79.60
|
82
|
20.40
|
|
Steroids
|
3
|
0.75
|
399
|
99.25
|
|
Ventilation
|
53
|
13.18
|
349
|
86.82
|
|
Details of diagnosis (based on ICD-10)
|
|
S02.0 Fracture of vault of skull
|
20
|
4.98
|
382
|
95.02
|
|
S02.1 Fracture of base of skull
|
24
|
5.97
|
378
|
94.03
|
|
S02.3 Fracture of the orbital floor
|
14
|
3.48
|
388
|
96.52
|
|
S02.7 Multiple fractures involving skull and facial bones
|
6
|
1.49
|
396
|
98.51
|
|
S02.8 Fractures of other skull and facial bones
|
15
|
3.73
|
387
|
96.27
|
|
S02.9 Fracture of skull and facial bones, part unspecified
|
1
|
0.25
|
401
|
99.75
|
|
S06.0 Concussion
|
121
|
30.10
|
281
|
69.90
|
|
S06.1 Traumatic cerebral edema
|
142
|
35.32
|
260
|
64.68
|
|
S06.2 Diffuse brain injury
|
10
|
2.49
|
392
|
97.51
|
|
S06.3 Focal brain injury
|
2
|
0.50
|
400
|
99.50
|
|
S06.4 Epidural hemorrhage
|
45
|
11.19
|
357
|
88.81
|
|
S06.5 Traumatic subdural hemorrhage
|
75
|
18.66
|
327
|
81.34
|
|
S06.6 Traumatic subarachnoid hemorrhage
|
37
|
9.20
|
365
|
90.80
|
Discussion
Success of a National Trauma Registry depend on the cooperative efforts; a short training
to existing system of health workers can improve the scenario[29]
[30]
[31]
[32]
[33] and needs to be cost effective also.[34] The burden from domestic and nondomestic injuries is increasing relentlessly worldwide,
accounts for 16% and road traffic injuries as the 9th leading cause of the morbidity
load globally; 5th in the developed world, whereas 10th in developing ones; most commonly
affecting men in their productive age group.[18] Major trauma accounts for approximately 10% of the world's deaths.[3]
[35]
[36]
[37]
[38]
[39] Mortality from trauma in rural areas is increased because of delay in discovery
of the victim or delay in accessing the trauma system.[40]
[41] The prevalence of trauma as a public health hazard in low-resource settings globally
has been severely neglected.[42]
The majority of trauma research is epidemiological in nature and despite the extensive
clinical trauma experience, literature shows limited clinical trauma research.[43] TR is a system of data collection that serves as a source of information for the
evaluation of trauma care for a specific set of injured patients meeting well-defined
inclusion criteria.[34]
[44]
[45] TRs are an integral part of outcome assessment tool in many developed trauma systems[45]
[46] and also have been recognized as one of the vital tool in filling the gap of injury
information perpetually refining the internalization of injury care.[47] Yet, many countries with limited resources have been able to establish useful TRs.[44]
[48]
[49] Initiation and continuation of a TR in any developing country is a challenging task,
though it is feasible with the potential to develop a nationwide database.[50]
TRs provide large longitudinal databases for analysis and policy improvement[51]
[52] and can be used to successfully study the prehospital triage and survival of major
trauma patients.[53] Global evidence supports an improved trauma care through the use of functionally
active and well-organized TRs to improve the management and outcome of trauma patients.[45]
[46]
[54]
[55]
[56] Besides demographic information, TRs provide information risk factors and outcomes
of injury in terms of death and disability with details of various levels of care
system (emergency medical services, emergency department, operating room, ICU, ward,
rehabilitation units, etc.)[44]
[56] In the absence of accurate routine medical record data or well-designed injury surveillance
systems, it is a challenge to understand the problems and risk factors for types of
trauma, design appropriate interventions to prevent and treat trauma, monitor the
effectiveness of interventions, and provide information to policy makers.[57]
[58]
[59]
For successful establishment of a multicenter TR, user friendly data entry system
and continuous data analysis are needed.[51] The use of the common trauma template has been shown feasible across international
registries for the majority of the data variables,[60] though the datasets of existing TRs frequently lack compatible definitions of common
data variables.[61]
[62]
[63]
[64]
[65] Further, uniformity in the outcome variables and injury scoring systems across international
trauma institutions is mandatory to obviate challenges to compare quality of the health
care systems.[60] Successful TRs will be resource and setting specific in design to improve trauma
care and outcomes, prevention programs are developed, and capacity-building goals
realized.[48] Analysis of a TR as early as 6 months can lead to useful information which has long-term
effects on the progress of trauma research and prevention.[50] The German Society for Trauma Surgery has contributed outcome analysis in relation
to the injury pattern.[66] TRs in developing settings are plausible tools for injury surveillance. Since “multiple
injuries” is not a homogeneous diagnosis, TRs collect prospective data from bigger
hinterland to provide valid data.[67]
[68] Regional registries will also ensure auditing enhancing policy making for injury
prevention and improving the quality of patient-centered care as no standard definition
exist for documenting, reporting, and comparing data from severely injured trauma
victims.[69]
[70]
Strengths of the Study
The study provides operationalization approach in establishing trauma-based registry
in India using web-based interface for recording essential epidemiological and clinical
profile of patients with TBI in uniform manner. This is essential as properly documented
information in the medical record is important to understand the mechanisms of injury,
the clinical characteristics, and to postulate how many deaths were preventable. To
the horizon of our knowledge, this study is the debut one that systematically collected
data on indigenously mastered registry in India. Furthermore, team-based approach
was used with paramedics managing most of the demographic, clinical, and investigation
variable with expert consultation for data regarding CT scan, electrocardiogram, and
follow-up of patient. This is notable as the emergency physicians if sensitized may
use similar approach to generate countrywide robust TBI data.
Limitations of the Study
The findings of this study are subject to some limitations. Some epidemiological and
clinical information may have been underreported due to the lack of proper documentation
on the medical records; examples of missing information include: alcohol use, type
of road where the injury occurred, pedestrian status, occupancy in a vehicle status,
and type of vehicle. There were discrepancy and duplication of data at many of the
places. Our study also does not account for patients who sought care in other nearby
health care facilities, died on site, died after the first 24 hours, or those who
survived their injuries; therefore, the results of this study should be interpreted
with caution as they may not be representative of all cases of TBI in our hinterland.
Future Directions of the Study
Future Directions of the Study
Fairly good amount of details were available for the majority of the variables that
enthused for the next phase of the study. This information can be used to develop
preventive interventions, emergency medical response services, and clinical guidelines
and to educate decision makers about the preventability of this public health problem.
Conclusion
TR has been globally recognized as one of the vital tool in bridging the gap of information.
This can help enhance quality of injury care by identifying gaps in the trauma management
system and find out opportunities of improvements. In absence of any national database,
the policy makers could not be well sensitized regarding the socioeconomic and health
impact of injury. We hope and believe that this study will provide a cost effective,
yet comprehensive data collection system on different parameters encompassing TBIs
including configuration of present scenario of prehospital care in our country.
