6 / Brief resume of the intended work:
6.1 Need for the study:
Traumatic brain injury (TBI) is a non-degenerative, non-congenital insult to the brain from an external mechanical force, possibly leading to permanent or temporary impairment of cognitive, physical, and psychosocial functions, with an associated diminished or altered state of consciousness. (WHO)
Traumatic Brain Injury (TBI) is one of the leading cause of mortality and morbidity with negative impact on Health Related Quality of Life (HRQoL). TBI has been termed as silent epidemic. In India 30,000 persons die and 125,000 persons are disabled every year due to TBI. The financial loss to the country is about Rs. 350 crores annually. These TBI’s can be due to motor vehicle accidents, assaults, gunshot wounds, etc.1
Leading causes of traumatic brain injury are falls(28%), road traffic accidents(20%), being struck by or against objects(19%), assaults(11%), suicidal attempts(1%), unknown causes(9%), other(12%).2
After a traumatic brain injury (TBI), individuals frequently report physical complaints, cognitive symptoms or changes in personality, which may influence their education, occupation, family and social relations and daily life and reduce their quality of life. In studying outcome after TBI, health-related quality of life (HRQoL) has recently attracted increased attention.3
Previous studies have reported lower HRQoL of individuals from 3 months to 9 years following TBI than in general population norms or control groups. Several of these studies have shown an association between HRQoL and the severity of the TBI.4-9
Advances in the neuro-imaging and the improved management have led to an increasing number of survivors with chronic sequelae, leading to increasing demand of rehabilitation services. Therefore it is crucial to identify the factors influencing the HRQoL in order to promote the maximal HRQoL improvements in these patients, who constitute a major workforce in developing countries.
So the aim of my study will be to identify the global and domain specific determinants of health related quality of life in traumatic brain injury survivors. Potential factors were sought among the variables such as age, gender, occupation, handedness, socio-economic class, severity of head injury, level of disability, cognitive functioning and post traumatic amnesia.
Hypothesis:
Null hypothesis:There will not be a significant relationship of age, gender,occupation, handedness, socio-economic status, severity of injury, level of disability, cognitive functioning and post traumatic amnesia with health related quality of life in traumatic brain injury survivors.
Experimental hypothesis:There will be a significant relationship of age, gender, occupation, handedness, socio-economic status, severity of injury, level of disability, cognitive functioning and post traumatic amnesia with health related quality of life in traumatic brain injury survivors.
6.2 Review of Literature :
Bazarian JJ,Blyth B,Mookerjee S,He H,McDermott M(2009) conducted a study with objective to estimate the independent association of sex with outcome after mild traumatic brain injury (mild TBI). They performed an analysis of a subset of an established cohort involving 1425 mild TBI patients presenting to an academic emergency department (ED). The associations between sex and 3 outcomes determined 3 months after the initial ED visit were examined: post-concussive symptom (PCS) score (0, 1-5, 6-16, > 16), the number of days to return of normal activities (0, 1-7, >7), and the number of days of work missed (0, 1-7, > 7). Males and females did not significantly differ with respect to the odds of poorer outcome defined by the number of days to return of normal activities or the number of days of work missed. Female sex is associated with a significantly higher odds of poor outcome after mild TBI, as measured by PCS score, after control for appropriate confounders. The observed pattern of peak disability for females during the childbearing years suggests disruption of endogenous estrogen or progesterone production. Attempts to better understand how mild TBI affects production of these hormones acutely after injury and during the recovery period may shed light on the mechanism of poorer outcome among females and putative therapeutic interventions.10
Dikmen SS,Corrigan JD,Levin HS,Machamer J,Stiers W,Weisskopf MG(2009) conducted a study to determine whether an association exists between traumatic brain injury (TBI) sustained in adulthood and cognitive impairment 6 months or longer after injury. 11 primary and 22 secondary studies that examined cognitive impairment by using performance measures for adults who were at least 6 months post-TBI. There was clear evidence of an association between penetrating brain injury and impaired cognitive function. Factors that modified this association included preinjury intelligence, volume of brain tissue lost, and brain region injured. There was also suggestive evidence that penetrating brain injury may exacerbate the cognitive effects of normal aging. We found clear evidence for long-term cognitive deficits associated with severe TBI. There was suggestive evidence that moderately severe brain injuries are associated with cognitive impairments. There was inadequate/insufficient evidence to determine whether an association exists between a single, mild TBI and cognitive deficits 6 months or longer postinjury.11
Knut Nestvold, Knut Stavem (2009)did a study to access health-related quality of life (HRQoL) and its determinants in a cohort who had sustained a traumatic brain injury 22 years earlier. Two hundred and fifty-nine individuals with traumatic brain injury responded to the Short Form-36 (SF-36) and General Health Questionnaire-30 (GHQ-30) questionnaires. SF-36 scores were compared with a general population sample (n¼6800). In multiple linear regression analysis determinants of physical and mental component summary scores (PCS, MCS) of SF-36 and the GHQ-30 total score were assessed. Except on the physical functioning scale, SF-36 scores were lower in the traumatic brain injury cohort than in the general population, after adjusting for age, sex and education. In multiple linear regression analysis, reported psychiatric disease and headache 1 day per month were associated with impaired MCS and GHQ-30 total scores. Age, severe headache 3 months after the injury, previous sick leave, lung disease and heart disease were associated with PCS. No injury variable was associated with HRQoL. Conclusions: Headache 3 months after traumatic brain injury and later comorbidity were associated with HRQoL 22 years after traumatic brain injury, but there was no association of HRQoL with injury data.3
Sharon Zhang, Linda J. Carroll, J. David Cassidy, Dr MedSc and Chris Paniak (2009) carried out a study to report self-rated health and factors influencing health after traffic-related mild traumatic brain injury. Subjects were 929 adults making a personal injury claim after a traffic collision. Data were self-reported through insurance application forms completed within 6 weeks of the injury. Multivariable multinomial logistic regression was applied to identify factors associated with self-reported general health. They concluded that those with traffic-related mild traumatic brain injury reported a decline in self-perceived general health. Potentially modifiable factors associated with poor post-injury health and suggested that these factors should be considered during early clinical intervention.12
Temkin NR,Corrigan JD,Dikmen SS,Machamer J(2009)did a study to determine the relationship between adult-onset traumatic brain injury (TBI) and social functioning including employment, social relationships, independent living, recreation, functional status, and quality of life 6 months or longer after injury. 14 primary and 25 secondary studies were identified that allowed comparison to controls for adults who were at least 6 months post-TBI. Those with moderate and severe TBI are clearly affected, but there was insufficient evidence of a relationship between unemployment and mild TBI. Penetrating head injury sustained in wartime is clearly associated with increased unemployment. TBI also adversely affects leisure and recreation, social relationships, functional status, quality of life, and independent living. TBI clearly has adverse effects on social functioning for adults. While some consequences might arise from injuries to other parts of the body, those with moderate to severe TBI have more impaired functioning than do those with other injuries alone.13
Skandsen T, Ivar Lund T, Fredriksli O, Vik A (2008) assessed long-term outcome in severe head injury survivors and relate this outcome to injury severity in 146 individuals admitted. They were separated into groups based on their level of consciousness at four weeks post injury. Glasgow Outcome Scale Extended (GOSE), participation in work/education (productivity) and posttraumatic epilepsy. Being independent in daily life but unable to work was the typical long-term outcome. Among oriented patients, almost all regained independency, whereas in the most severe group, poor outcomes and posttraumatic epilepsy was common.14
Marcela Lippert-Gruner, Marc Maegele, Heinz Haverkamp, Norfrid Klung Christrop Wedekind (2007) conducted a study to investigate HRQoL using the SF-36 questionnaire in 49 patients with severe TBI (Glasgow Coma Scale<9 for more than 24 hours) with and without concomitant polytrauma 6 and 12 months after injury. They concluded that the SF-36 score profiles 6 and 12 months after trauma were similar. Scores 12 months after trauma, however, were higher in 7/8 dimensions indicating an improvement over time. Similar observations were made for physical and mental sum scores. There was no difference in the SF-36 scoring pattern between the patients with isolated TBI and the patients with concomitant polytrauma, except for physical functioning after 12 months. While there is significant overall improvement of HRQoL over time, sTBI appears to bear major influence on post-traumatic HRQoL and outcome.15
B. Van Baalen, E. Odding, A. I. R. Maas, G. M. Ribbers, M. P. Bergen, H. J. Stam (2003) conducted a study with an aim to review current methods for classifying initial severity and final outcome in traumatic brain injury (TBI) and to suggest a direction and form of further research. The literature on valid and reliable measurements used in TBI-research for classifying initial severity and final outcome was reviewed. In results classifying initial severity in patients with head injury according to clinical condition or CT-parameters is valid. Classifying outcome according to measurement tools of disability showed adequate validity and reliability. Future research in TBI outcome, particularly in rehabilitation medicine, should focus on determinants of outcome, identifying those patients who will have the greatest chance of benefiting from intensive rehabilitation programmes. More research is needed to determine the long-term functional outcome in TBI, the long-term socio-economic costs, and the influence of behavioural problems on family cohesion. Finally, validation of outcome measures is required in the TBI- population; the relative value of various outcome measures needs to be determined, and the usefulness and applicability of measures for health related quality of life in TBI should be established.16
Terry Stancin, Dennis Drotar, H. Gerry Taylor, Keith Owen Yeates, Shari L. Wade, Nori Mercuri Minich (2002)examined the nature and predictors of HRQL outcomes in children with moderate to severe TBI an average of 4 years post injury. The study used a concurrent cohort-prospective design involving post injury assessments of 3 groups of traumatically injured children and their families including 42 with severe TBI, 42 with moderate TBI, and 50 with orthopaedic injuries only. Predictors included indices of injuryseverity, social factors, and ratings of preinjury child behaviour problems and school performance. Findings underscore the importance of using comprehensive measures of HRQL, along with traditional indicators of functional outcomes, when evaluating the longer-term impact of injuries in children. Identification of predictors suggests the need for close monitoring and intervention of high-risk children.17
6.3 Objective of the study:
  • The objective of the study is to identify the global and domain specific determinants of Health Related Quality of Life in Indian Traumatic Brain Injury survivors.

7 / Materials and Methods:
7.1 Source of Data
  1. Employee State Insurance Hospital. Rajajinagar, Bangalore.
  2. K.C.General Hospital, Bangalore.
  3. Neuro specialty hospitals in and around Bangalore.
7.2 Method of collection of data:
Population : Subjects diagnosed with Traumatic Brain Injury
Sample design : Convenient Sampling
Sample size : 30 subjects
Study design : Predictive Correlational Study
Statistics:
  • Student’s t-test.
  • ANOVA.
  • Multi Variant Regression Analysis.
Inclusion Criteria:
  1. Subjects diagnosed with traumatic brain injury.
  2. Subjects of both genders.
  3. Subjects of age group between 20-60yrs.
Exclusion Criteria:
  1. Subjects suffering from any Pre-existing Illness.
  2. Subjects with GCS < 15 at 6th month post injury.
  3. Non-cooperative subjects at 6th month post injury.
  4. Subjects with new injuries/diseases within the 6 months post Traumatic Brain Injury.
Materials used :
  • Couch
  • Pen
  • Paper
Methodology :
Subjects diagnosed by Neuro-physician as traumatic brain injury and who fulfill inclusion & exclusion criteria will be included in the study. Informed consent will be taken from the subjects or family.Clinical and demographic data will be gathered from the patients and their medical records during the first week of post injury. It will include age, gender, handedness, occupation, socio-economic status, severity of injury,level of disability, cognitive functioning, and post traumatic amnesia. Severity will be assessed by the duration patient remained unconscious, amount of disability will be assessed using disability rating scale and cognitive functioning will be assessed by Rancho Los Amigos Cognitive Scale. Subjects will be followed up during the sixth month post injury and quality of life will be assessed using SF-36 questionnaire, which is a generic health status questionnaire and reports HRQoL on eight scales: physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning and mental health. In addition, the 8 domains of SF-36 are weighted and aggravated to 2 summary scores: Physical Component (PCS) And Mental Component (MCS). Health related quality of life will be correlated with age, gender, occupation, handedness, socio economic status, severity of injury, level of disability, cognitive functioning, and post traumatic amnesia to identify the global and domain specific determinants of health related quality of life in traumatic brain injury survivors.
Measuring tools :
  • The Short Form 36 (SF-36) Questionnaire.
  • Rancho Los Amigos Cognitive Scale (RLA).
  • Disability Rating Scale (DRS).
  • Duration of Loss of Consciousness (LOC).
  • Galveston Orientation Amnesia Test (GOAT).
  • Glasgow Coma Scale(GCS).
7.4Ethical Clearance:
As this study involves human subjects the Ethical Clearance has been obtained from the Ethical committee of Padmashree Institute of Physiotherapy, Nagarbhavi, Bangalore as per the ethical guidelines for Bio-medical research on human subjects, 2000 ICMR, New Delhi.
8 /

List of References:

  1. Brig S Sudarsanan (Retd), Lt Col S Chaudhary (Retd), Surg Capt AA Pawar, K Srivastava. Psychiatric Effects of Traumatic Brain Injury. MJAFI 2006; 62 : 259-263
  2. Langlois JA, Rutland-Brown W, Thomas KE. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. Atlanta (GA): Centers for Disease Control and Prevention, Nation Center for Injury Prevention and Control; 2006
  3. Knut Nestvold & Knut Stavem. Determinants of health-related quality of life 22 years after hospitalization for traumatic brain injury. Brain Injury, January 2009; 23(1): 15–21
  4. Emanuelsson I, Andersson Holmkvist E, Bjo¨rklund R, Sta°lhammar D. Quality of life and post-concussion symptoms in adults after mild traumatic brain in adults after mild traumatic brain injury: A population study in western Sweden. Acta Neurologica Scandinavica 2003;108: 332–338.
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  7. Klonoff PS, Snow WG, Costa LD. Quality of life in patients 2 to 4 years after closed head injury. Neurosurgery 1986;19: 735–743.
  8. Colantonio A, Dawson DR, McLellan BA. Head injury in young adults: Longterm outcome. Archives of Physical Medicine and Rehabilitation 1998;79:550–558.
  9. Whitnall L, McMillan TM, Murray GD, Teasdale GM. Disability in young people and adults after head injury: 5–7 year follow up of a prospective cohort study. Journal of Neurology, Neurosurgery & Psychiatry 2006;77:640–645.
  10. Bazarian JJ,Blyth B,Mookerjee S,He H,McDermott M. Sex Differences in Outcome after Mild Traumatic Brain Injury. J Neurotrauma.2009 Nov 25. [Epub ahead of print]
  11. Dikmen SS,Corrigan JD,Levin HS,Machamer J,Stiers W,Weisskopf MG. Cognitive outcome following traumatic brain injury. J Head Trauma Rehabil.2009 Nov-Dec;24(6):430-8.
  12. Sharon Zhang, Linda J. Carroll, J. David Cassidy, Dr MedSc and Chris Paniak. Factors Influencing Self-Rated Health In Traffic-Related Mild Traumatic Brain Injury. J Rehabil Med 2009; 41: 1062–1067.
  13. Temkin NR,Corrigan JD,Dikmen SS,Machamer J. Social functioning after traumatic brain injury. J Head Trauma Rehabil.2009 Nov-Dec;24(6):460-7.
  14. Skandsen T, Ivar Lund T, Fredriksli O, Vik A. Global outcome, productivity and epilepsy 3--8 years after severe head injury. The impact of injury severity. Clin Rehabil. 2008 Jul;22(7):653-62.
  15. Marcela Lippert-Gruner, Marc Maegele, Heinz Haverkamp, Norfrid Klung & Christrop Wedekind. Health-related quality of life during the first year after severe brain trauma with and without polytrauma. Brain Injury, May 2007; 21(5): 451–455.
  16. B. Van Baalen, E. Odding, A. I. R. Maas, G. M. Ribbers, M. P. Bergen, H. J. Stam. Traumatic brain injury: classification of initial severity and determination of functional outcome. Disability And Rehabilitation, 2003; VOL. 25, NO. 1, 9± 18.
  17. Terry Stancin, Dennis Drotar, H. Gerry Taylor, Keith Owen Yeates, Shari L. Wade, and Nori Mercuri Minich. Health-Related Quality of Life of Children and Adolescents After Traumatic Brain Injury. Pediatrics February 2002 Vol. 109 No. 2.