a b s t r a c t

Objective: The objective of this study was to test the validity of the Canadian CT Head Rule in cases of minor Traumatic brain injury in an Indian emergency department (ED). A secondary objective was to com- pare of the patterns of neuroradiology references between the emergency physician and the neurosurgeon. Methods: The study was prospectively conducted between July 2019 and July 2020. Patients satisfying the inclu- sion criteria were subjected to CCHR and the result was documented. The neurosurgeon was consulted for the final decision. In case of disagreement between the neurosurgeon and the EP, the decision of neuro-radiology was taken by the neurosurgeon.

Results: A total of 101 patients satisfied the inclusion criteria. 62 subjects fulfilled the CCHR. Out of 62 subjects who fulfilled the CCHR criteria, 46 (74.1%) were reported to have Normal CT scans, while 16 had either haemorrhages (n = 12) or contusions (n = 4). All the subjects who didn’t fulfil the CCHR (n = 39), were re- ported to have normal CT scans. The EPs used CCHR in all cases of mild TBI while the neurosurgeons chose to get CT brains in all the subjects based of clinical gestalt.

CCHR had an observed sensitivity of 100% and specificity of 45.8%. Conclusion: The CCHR has 100% sensitivity as a screening tool for patients requiring CT brains in case of TBI though the specificity is found to be rather low (45.8%). EPs show a higher level of awareness and inclination to use CDRs in cases of minor TBI to direct the decision for neuro-radiology, in comparison to neurosurgeons. ED residents re- ported comfort in mobile application based usage of the rule.

(C) 2021

1. Introduction
   1. Background

Trauma, especially related to Road traffic accidents, is one of the most common reasons for patients to present to the emergency department (ED). A large subset of these patients have traumatic brain injury of varying severity. The decision to perform computerised tomography (CT) on these patients is something that the ED physician may face mul- tiple times during a single shift. A CT brain, though non invasive, is not a very benign investigation.

There is significant literature that elaborates upon the potential harm of even a single CT brain. The radiation exposure.from a single non contrast CT brain may vary from institution to institution but on an average the number is taken as 2 milliesieverts (mSv). This can be put in perspective with the fact that this is equivalent to the

* Corresponding author.

E-mail addresses: [email protected] (I. Lamba), [email protected] (V. Shinde), [email protected] (S.S. Daniel).

accumulative natural background dose that an average human receives over the course of 8 months [1]. The cumulative lifetime risk of cancer from a single CT brain is a function of age as described by Brenner [2]. It demarcates the importance of clinical decision making rules for order- ing imaging in cases of TBI, especially in the paediatric age group.

Another factor that needs to be taken into account is the Financial burden of conducting a CT brain- both from the patient’s and the institution’s point of view. A non contract CT brain costs a minimum of INR 2550 (approximately $32) which is a significant amount for most of the Indian patients [3]. The subject of the high cost of neuro- radiology in the Indian clinical scenario has been discussed in recent lit- erature [4]. While a conservative strategy proves to be a cost effective one, the screening criteria needs to be highly sensitive so as to ensure patient safety while keeping the cost of care at the minimum. These were the precise inferences drawn by Smits et al. when they reported that when a highly sensitive decision making tool like the Canadian CT Head Rule (CCHR) was applied, it led to significant decrease in the cost of care while ensuring patient safety [5].

https://doi.org/10.1016/j.ajem.2021.02.064

0735-6757/(C) 2021

• 1. Importance

The number of fatalities as a result of road traffic accidents in India have steadily risen over the past few years: from 94,970 in 2005 to 1,51,420 in 2018 [6]. Traumatic brain injuries (TBIs) form a significant subset within this data pool. Estimates suggest that more than 50% of all trauma related deaths in India have TBI as the major contributory cause. But a deeper review of literature reveals a rather ironical prob- lem. There is a conspicuous dearth of literature focusing on TBI in the Indian population [7].

With this perspective, we opted to devise a study around patients presenting with minor TBI to the ED of a tertiary care teaching hospital in urban Maharashtra. We decided to study validity of the application of CCHR to the presenting population, while conducting a comparative analysis of the decision making processes opted by ED physicians and the neurosurgeons for subjecting the patients to CT imaging.

• 1. Goals of the study

The study was designed with the purpose of corroborating the effec- tiveness of the CCHR as tool to screen the sub-set of patients of minor TBI who may require a CT brain, in the setting of an Indian ED. Second- arily, we intended to study the differences, if any, in the plan of neuro- radiology reference, for patients of minor TBI, between the emergency physician(EP) and the neurosurgeon and analyse their respective pro- pensity to adhere to the clinical decision making rule under evaluation. To the best of our knowledge, this is the first comparative analysis between EP’s and neurosurgeons regarding the propensity to utilize a clinical decision rule in the setting of TBI and the question of whether

to obtain CT imaging.

1. Material and methods
   1. Study design and setting

We performed a prospective, observational study between July 2019 and July 2020. The study was approved by the institutional ethics com- mittee. Data was collected concerning the decision making pathways regarding neuro-imaging opted by the ED physicians and the neurosur- geons, in cases of minor TBI. The participating hospital is a 1500 bed ter- tiary care teaching hospital. The ED itself is a 32 bed department with the annual patient load ranging between 36,000 to 50,000 patients. Each of the departments of Neurosurgery and Emergency Medicine sup- ports a formal residency training programme. During the study period, the patients were primarily assessed by residents from the departments of Emergency Medicine and Neurosurgery, with oversight by attending physicians from both the departments. At the time of the study, the ED did not have Trauma level designation.

• 1. Participant selection and design
     1. Inclusion criteria

1. Non-pregnant patients above the age of 16 years presenting to the ED with a history of head trauma.
2. Only patients with minor TBI defined as GCS of 13-15 at 30 min from the incident trauma.
   • 1. Exclusion criteria
3. Patients who had visited another Healthcare facility before arriving to the study centre.
4. Patients on anticoagulant therapy.
5. Patients with history of Alcohol intake within two hours preceding presentation to the ED.
6. Patients in whom both the neurosurgeon and the ED physician reached a consensus that CT scan of the brain was not necessary.

A detailed documentation of the patient history, incident leading to injury, Vital parameters and systemic examination was done. After the

CT brain, if an intracranial lesion attributable to the trauma was discov- ered, the patient was advised transfer into the neurosurgical unit. If the CT scan was reported to be normal, patients were subjected to neuro- observation in the ED for a minimum of 12 h. As per the ED protocol, pa- tients were observed for:

1. Deterioration in GCS score.
2. Change in pupillary response.
3. Seizure activity.
4. Persistent Vomiting.
5. Delayed appearance of signs of basal Skull fracture: Haemotympanum, cerebrospinal fluid(CSF) rhinorrhea, CSF ottorhea, raccoon eyes, battle’s sign.
   1. Interventions

Standard hospital protocol of centre where the study was conducted, as designed by the Department of neurosurgery, states that all patients of minor TBI should undergo non contrast CT (NCCT) brain. CCHR usage was not mandatory.

senior physicians from the ED trained the ED residents regarding the appropriate utilisation of CCHR and was promoted as the standard of care. The residents were also encouraged to use web based mobile phone applications to check the criteria of CCHR when encountered with a patient. MDCalc Medical Calculator(TM) was used for the purpose. As per the CCHR, presence of any one of the following findings war- ranted the need for a CT scan of the brain in a case of minor TBI:

1. GCS < 15 at 2 h from trauma.
2. Suspected open or depressed skull fracture.
3. Age >= 65 years.
4. More than one episode of vomiting.
5. Retrograde amnesia > 30 min.
6. Dangerous mechanism (fall > 3 ft or struck as pedestrian).
7. Any sign of basal skull fracture [8].

If one or more of the criteria were satisfied, the patient underwent a non contrast CT scan of the brain. If none of the criteria were satisfied, the patient underwent a neurosurgical consult. The neurosurgeon was informed regarding the results of the CCHR. If the neurosurgeon deemed a CT brain necessary (based on clinical gestalt), the neurosurgeon’s decision would prevail in the case. If the neurosurgeon concurred with the ED physician’s decision, the patient would be ex- cluded from the study.

All patients included in the study underwent a mandatory ED obser- vation period of twelve hours, during which time if any signs of neuro- deterioration were noted, the patients were subjected to a repeat CT brain and transferred to the neurosurgical unit. If not, no further neuro-radiology would be performed.

• • 1. Criteria for re-imaging

In patients whose first CT was negative for abnormalities, a repeat CT was obtained if during the ED observation period any one of the above mentioned parameters showed abnormality i.e. deterioration in GCS, change in pupillary response, seizure activity, persistent vomiting or de- layed appearance of any signs of basal skull fracture.

The ED floor consultant incharge of the shift audited every case of minor TBI to ensure the application of the intervention to each patient. If a case was missed prospectively in the audit, the case records were checked retrospectively for application of CCHR. If CCHR was not ap- plied to a participant, they were excluded from the study sample. The CT scans were reported by a qualified radiologist.

The ED care pathway and decision algorithm is illustrated in Fig. 1.

• 1. Methods of measurement

Data entries were drawn from the hospital’s clinical records. Patient variables (age, gender, GCS score),mechanism of head injury (road

Fig. 1. Decision algorithm for a case of minor TBI presenting to the ED.

traffic accident, assault, fall), neuro-protective interventions provided (if any) and details of Wound management were documented.

decision pathways opted by EPs and neurosurgeons were also docu- mented and entered into the data pool.

In case proper documentation of data was unavailable or missing, the subject was excluded from the study.

• 1. Outcomes
• Primary outcome was ascertained to test the validity of CCHR as a screening tool for patients requiring CT brains in cases of minor TBI.

Sensitivity and specificity were decided to be the criteria for deter- mining validity.

(ii) Secondary outcome was the comparative analysis of the patterns of neuro-radiology references between the Emergency physician and the neurosurgeon and their tendencies to comply with CCHR.

• 1. Analysis

Data was entered into Microsoft Excel and analysed using SPSS (Sta- tistical Package for Social Sciences) Software 20. Data entry was done by

the ED consultant on duty at the time. Categorical variables were expressed in terms of frequency and percentage and continuous vari- ables were expressed in terms of mean and standard deviation.

1. Results

A total of 553 patients were analysed of which 101 satisfied the in- clusion criteria.

• 1. Characteristics of study subjects
     1. Demographics

Of the 101 included subjects, 31 (30.7%) were females while 70 (69.3%) were males. Majority of the patients (42.6%) were between the ages of 21 to 30 years.

• • 1. Etiology

Majority of the patients (59.4%) presented to the ED with a history of road traffic accident (RTA). 22.7% presented with a history of fall while rest reported physical assault as the mechanism leading to the head injury.

• • 1. Care pathway

All the patients were admitted in the ED for neuro-observation. Out of these 7 patients (6.9%), all of whom were discovered to have haemorragic lesions in the NCCT, gradually deteriorated and required the insertion of an endotracheal tube for airway protection. 16.8% of the subjects required neuro-protective intervention with intravenous Mannitol and anti-epileptics while 24.7% of the patients required sutur- ing and closure of scalp injuries.

In 100% of the patients (n = 85) whose initial CT scans were re- ported to be normal, no further neuro-deterioration was noted.

• • 1. Disposition

65 patients were discharged in optimum neurological condition post the compulsory institutional period of neuro-observation. 35 patients were advised admission in the neurosurgical care unit, out of which only 12 consented to the same while 23 (22.8%) opted for a discharge against medical advise (AMA). All 23 cited inability to bear the cost of further management as the reason for discharge AMA. One patient died during their stay in the ED because of non-trauma related co- morbidities.

• 1. Primary results

As per the study methodology, all the included patients (n = 101) underwent a NCCT brain study, irrespective of the Diagnostic pathway that the CCHR directed. The neurosurgeons were not blinded to the de- cision of the EPs regarding the CT scan as the EP’s decision was docu- mented in the patient’s care plan. Table 1 displays the respective CT scan results of patients who fulfilled one or more of the CCHR criteria and also the ones who did not. Out of 62 subjects who were directed to the CT brain pathway as per the CCHR criteria, 46 (74.1%) were re- ported to have normal CT scans, while 16 had either haemorrhages (n = 12) or contusions (n = 4). All the subjects who didn’t fulfil any criteria of the CCHR (n = 39), were reported to have normal CT scans.

Table 1

Outcome of application of CCHR to the patients

CT scan warranted necessary as per CCHR CT scan lesion noted Total

	No	Yes
Yes	46(74.1%)	16(26.7%)	62
No	39(100%)	0	39
Total	85	16	101

• 1. Secondary results

The emergency physician utilized the CCHR to guide the decision for neuro-radiology in all cases of minor TBI. The neurosurgeons requested CT scans in the entire patient population (n = 101), irrespective of how the subjects fared on the CCHR. No patients had to be excluded from the study sample due to consensus between the EPs and neurosurgeons to not proceed with neuro-radiology (exclusion criteria 4).

Additionally, ED residents reported preference to use mobile appli- cation based calculation of the CCHR criteria instead of checking the patient’s eligibility from memory alone.

1. Discussion

This study is the first in an Indian patient population to compare emergency physicians with neurosurgeons with respect to the use of a clinical decision tool regarding CT utilisation in the setting of minor TBI. There is severe dearth of data regarding road traffic accidents in gen- eral, and especially regarding TBI, coming out of India [7,9,10]. Regional studies have been challenged by the lack of a comprehensive unified na- tional registry. The National Injury surveillance Centre, established by the Ministry of Health and Family Welfare, Government of India is the pilot programme initiated in this direction but it is still in its nascent

stages [11].

Comprehensive data will enhance the understanding of trauma and facilitate a standardized approach to entities such as TBI [12]. The ad- vent of formal academic training in Emergency Medicine has remedied the situation to a certain extent but centres with qualified ED physicians are still rare.

The standardized training methodology opted for ED residents relies heavily on an algorithmic approach and on clinical decision making rules (CDRs) [13,14]. While CDRs are not beyond error and are constantly sub- ject to change [15], reliance upon them creates an environment of pro- fessional responsibility, resource efficiency and systemic accountability, making the process of Health care delivery patient centric.

Non-adherence to CDRs is common. Ozan and Atac published a study not unlike ours in which they reported dismal numbers not only for incli- nation to use CDR for deciding upon neuro-radiology but also about awareness about the CDR itself. Even in that population, comprising of EPs, neurosurgeons and radiologists, EPs displayed the highest levels of awareness and actual utilisation of CDR [16]. An interesting study out of New York Presbyterian studied the attitudes of physicians towards the use of CCHR with the intention to reduce radiation exposure. The study reported an extremely significant rise (84%) in the clinician knowl- edge regarding the use of CCHR. But the same study also reported that 83% of the participants were only ‘moderately’ inclined to use it clinically and that too was when it appealed to them and if it was mandated by the hospital authorities [17]. This leads to the element of responsibility that hospitals must accept in mandating the use of CDRs.

Providing healthcare in India, especially emergency care, is a chal- lenge because of the unfavourable ratio between the number of patients requiring care and the resources available for the provision of the said healthcare. This becomes exceedingly relevant in cases of neuro- trauma which tend to utilize significant resources in the ED, both in per- sonnel and infrastructure. A very pertinent analysis of this problem was done by Devi et al. from National Institute of Mental Health and Neuro- sciences (NIMHANS) who found that of all the TBI referrals that their ED received, approximately half (48%) had normal CT scans. Arbitrary re- ferrals with no basis in any CDR lead to wastage of an excessively lim- ited resource in any institute: the CT scanner [18].

The indiscriminate approach to getting CT scans by certain physi- cians may also stem from the academic training environment. In our study a major difference between the treating EPs and the neurosur- geons was the level of awareness regarding the CCHR that the two groups displayed (EPs being more aware). The same statistical differ- ence was observed in the level of acceptance towards a unified CDR

by the residents of both the specialities: emergency residents being more inclined to use CCHR. Inclusion of clinical decision making rules in standard medical teaching can increase the level of acceptance and comfort that a physician/surgeon may display regarding the usage of CDRs in clinical practise.

Resource efficiency of the CCHR has been proven beyond reasonable doubt [19]. This becomes particularly relevant in the Indian setting, where emergency medicine has to be practised in a parsimonious man- ner. The same point is highlighted in our study where 22.8% of the sub- jects decided to take discharge AMA because of the concern for the cost of care. Such high frequency of discharge AMA should be concerning in any patient population, especially one that concerns TBI. This is not a problem exclusive to India as was clearly reflected in the recent study by Jasperse et al. who reported that in adult trauma patients, the unin- sured ones were highly likely to opt for discharge AMA [20]. Being unin- sured was cited as a reason for discharge against physician advice in 27% of the cases in their study which correlates closely with our statistics re- garding the same.

One may even argue that in the resource challenged setting of India, a highly sensitive tool as CCHR [21] is something that should not be viewed as an option but as an obligation. The sensitivity of CCHR to cap- ture clinically significant CT brain findings and its negative predictive value for patients who do not require neuro-radiology is reported to be 100% in our data set which correlates well with previous studies [22,23].

In summary, we believe that education and training as well as con- sensus guidelines for Indian hospitals can improve patient care. Our study shows that the CCHR clinical decision rule is not utilized in the same manner between EPs and neurosurgeons, and we believe that more comprehensive utilisation of the CCHR can prevent unnecessary CT scans in patients with minor TBI.

1. Limitations
2. The study was conducted at a single academic centre. Conduction of similar studies in other multidisciplinary centres, academic and otherwise, may provide valuable insights into the attitudes of physicians towards CDRs.
3. The study was conducted in a tertiary care teaching hospital with a well established residency programme in Emergency Medicine. The level of awareness and the attitude of the EPs towards CCHR may not correlate well with EPs working in non-academic centres.
4. Conclusions

• The CCHR has 100% sensitivity as a screening tool for patients requir- ing CT brain for minor TBI though the specificity is found to be rather low (45.8%), in the setting of an Indian academic ED.
• The CCHR has 100% negative predictive value for patients of minor TBI who do not need a CT brain.
• EP’s in our study demonstrated a higher level of awareness and pro- pensity to use the CDR in the case of minor TBI to guide imaging deci- sions, compared to neurosurgeons.
• EPs reported preference to use mobile phone application based calcu- lation of the CCHR instead of relying on memory alone.
• Mandatory usage of CCHR would likely result in fewer negative CT scans, lower utilisation of Hospital resources and prevent discharge AMA. It would likely decrease ED boarding times for this patient pop- ulation and help to mitigate ED overcrowding

Disclosure of funding/grants

No funding/grant was given for this article.

Declaration of Competing Interest

There is no conflict of interest. A separate disclosure in accordance with the journal guidelines is provided for the same.

Acknowledgements

All persons who have made substantial contributions to the work re- ported in the manuscript (e.g., technical help, writing and editing assis- tance, general support), but who do not meet the criteria for authorship, are named in the Acknowledgements and have given us their written permission to be named. If we have not included an Acknowledge- ments, then that indicates that we have not received substantial contri- butions from non-authors.

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