INTBIR GLOBAL COLLABORATIONS TO ADVANCE THE CARE FOR TRAUMATIC BRAIN INJURY CIHR - IRCS ONE MIND ADAPT TRACK-TBI. Andrew IR Maas

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1 GLOBAL COLLABORATIONS TO ADVANCE THE CARE FOR TRAUMATIC BRAIN INJURY CIHR - IRCS INTBIR Hannelore Kohl Stiftung ADAPT ONE MIND TRACK-TBI Andrew IR Maas

2 TBI: A Global Problem and a Leading Cause Of Death And Disability Concerted efforts and global collaborations are needed to address this vast global health problem.

3 Worldwide TBI Incidence By Age-standardized Rates Worldwide: 50 million new cases/year. LMIC: highest burden. Global Cost: $400 billion/year

4 Crude And Age-adjusted Rates Of Hospital Discharge In Europe After TBI Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, Maas A. Lancet Public Health 2016; 1: e76 83.

5 Differences In Epidemiology European Union US Population (millions) New cases 2.5 million 3.5 million Hospital admissions 1.5 million 282,000 Deaths 57,000 56,000 An international consensus is needed on definitions and standardized epidemiologic monitoring of TBI.

6 Costs TBI results in substantial healthcare and societal costs. Global costs: 400 billion dollars/year ~ 1 out of every 200 dollars of global economic output Strategies for TBI prevention are urgently needed and could deliver costs savings.

7 TBI Is A Process, Not An Event Lifelong disability is common: Impaired memory and problem solving Difficulty in managing stress and emotional upsets Problems in controlling ones temper Disturbed relationships Increased risk of neurodegenerative disease and Parkinson Reduced life expectancy (3 times more likely to die) Studies are needed to better understand links between TBI and an increased risk of later neurologic diseases.

8 The Multiple Faces Of TBI New approaches are needed to improve the precision of diagnosis, classification and characterization of TBI using multidomain approaches.

9 Broken links in the trauma chain worsen outcome and confound TBI research Healthcare policies should aim to improve access to acute and post acute care.

CENTER-TBI: An InTBIR Project Our global aims are: To improve characterization and classification of TBI in Europe, with inclusion of emerging technologies.

10 CENTER-TBI: An InTBIR Project Our global aims are: To improve characterization and classification of TBI in Europe, with inclusion of emerging technologies. To identify the most effective clinical care and to provide high quality evidence in support of treatment recommendations and guidelines. 46 scientific Participants Collaboration with funding agencies: European commission NIH/NINDS CIHR USDoD OneMind

11 CENTER-TBI: An Integral Picture ESSENTIAL COMPONENTS OF CENTER-TBI Provider profiling: finger print of center characteristics, in terms of organization, structure, protocol, process. Evidence generation: Core data study (N=5400), Registry (N= ) Optimizing existing evidence: Living Systematic Reviews (LSR) Knowledge transfer

12 Provider Profiling = The assessment of structural and process characteristics of hospitals and countries Structure: e.g. n beds, volume, equipment, location Process: e.g. policies, guidelines, management strategies Acknowledgment We would like to thank all CENTER TBI investigators and their teams for the completion of the provider profiling questionnaires

13 Provider Profiling Papers 1. Cnossen MC, Polinder S, Lingsma HF, Maas AI, Menon D, Steyerberg EW; CENTER-TBI Investigators and Participants. Variation in Structure and Process of Care in Traumatic Brain Injury: Provider Profiles of European Neurotrauma Centers Participating in the CENTER-TBI Study. 2. Foks KA, Cnossen MC2, Dippel DWJ, Maas A, Menon D, van der Naalt J, Steyerberg EW, Lingsma H, Polinder S, on Behalf of CENTER-TBI Investigators and Participants. Management of mild traumatic brain injury at the emergency department and hospital admission in Europe: A survey of 71 neurotrauma centers participating in the CENTER-TBI study. 3. Cnossen MC, Lingsma HF, Tenovuo O, Maas AIR, Menon D, Steyerberg EW, Ribbers GM, Polinder S, and CENTER-TBI Investigators and Participants. Rehabilitation after traumatic brain injury: A survey in 70 European neurotrauma centres participating in the CENTER-TBI study. 4. Huijben JA, van der Jagt M, Cnossen MC, Kruip MJHA, Haitsma I, Stocchetti N, Maas A, Menon D, Ercole A, Maegele M, Stanworth SJ, Citerio G, Polinder S, Steyerberg EW, Lingsma H, on Behalf of the CENTER-TBI Investigators. Variation in blood transfusion and coagulation management in Traumatic Brain Injury at the Intensive Care Unit: A survey in 66 neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study. 5. Cnossen, M. C., Huijben, J. A., van der Jagt, M., Volovici, V., van Essen, T., Polinder, S., Nelson, D., et al. Variation in monitoring and treatment policies for intracranial hypertension in traumatic brain injury: A 2 survey in 66 neurotrauma centers participating in the CENTER-TBI study.

14 Results: Pre-hospital Characteristics Characteristic % Selective dispatching of ambulances 73% Standard EMS response: - BLS - ALS 41% 59% Approach at the scene - stay and play - scoop and run 61% 39% Pre-hospital triage 74% ATLS protocols available 94%

Living Systematic Reviews From Evidence To Practice: The Intbir Approach Current sources of evidence: Clinical trials and studies Systematic reviews and meta-analysis Limitations of

15 Living Systematic Reviews From Evidence To Practice: The Intbir Approach Current sources of evidence: Clinical trials and studies Systematic reviews and meta-analysis Limitations of current evidence: Substantial delay between primary study publication and inclusion in systematic review (Elliott et al 2014; Bragge et al 2011) - Median delay years Evidence-practice gap

16 Optimizing Existing Evidence: The Concept Of Living Systematic Reviews High quality and up to date online summary of health research Design: following publication, new searches are run every three months Online manuscripts are continuously updated

17 LSR s In TBI: Pioneered By CENTER-TBI Cnossen MC, Scholten AC, Lingsma HF, et al. Adherence to Guidelines in Adult Patients with Traumatic Brain Injury: A Living Systematic Review. J Neurotrauma Aug 25. doi: /neu [Epub ahead of print] Brazinova A, Rehorcikova V, Taylor MS, et al. Epidemiology of Traumatic Brain Injury in Europe: A Living Systematic Review. J Neurotrauma Aug 25. doi: /neu [Epub ahead of print] Mondello S, Sorinola A, Czeiter E, et al. Blood-based protein biomarkers for the management of traumatic brain injuries in adults presenting with mild head injury to emergency departments: a living systematic review and meta-analysis. J Neurotrauma Accepted for Publication.

18 LSR and Guidelines 1996: 1 st edition; 2000: 2 nd edition; 2007: 3 rd edition; 2016: 4 th edition Summarize evidence Present evidence-based recommendations

19 Critical Pathway For Treatment Of Intracranial Hypertension In The Severe Head Injury Patient

20 Practical Recommendations

21 Limitations of current guidelines Lack of evidence to provide strong recommendations Substantial time lags Clinical appeal low Fixed; cannot be tailored to local settings

22 New model for linking evidence to practice recommendations LSR s Tailor to local setting Evidence-base Practice Recommendations Where evidence lacking: Add medicine-based evidence In a new international collaboration: an agreed set of priority living guidelines in TBI could be maintained, with the LSRs selected to feed directly into the living guidelines.

23 Elements necessary for producing living recommendations Living systematic review Living Evidence profile Living Evidence to decision table Living Guideline Panel Living Peer review Process Living Publication and Dissemination Living Budget

Evidence Generation Core Study: Number EU countries: 20 Number EU centres : 65 Number centres non-eu: 3 FPI: 19 December 2014 Current Recruitment Status CORE Data Collection 5,041 ER

24 Evidence Generation Core Study: Number EU countries: 20 Number EU centres : 65 Number centres non-eu: 3 FPI: 19 December 2014 Current Recruitment Status CORE Data Collection 5,041 ER 1,056 ADM 1,533 ICU 2,462 Registry EU 21,724 China 13,624 India 2,568 Recruitment end: December 1st 2017 ER: Discharge from ER Adm: Primary admission to ward ICU: Primary admission to ICU

25 Aims of registry Internal validity - Representativeness of core data (overall and site-specific) External validity -Generalizability versus general caseload (registries) CER - Focus on structural aspects

26 Median Age In Core And Registry Among The Different Strata

27 % Males In Core And Registry Among The Different Strata

28 Registry: Reasons Not Enrolled ALL STRATA ALL STRATA (N=15174*) ER STRATUM (N=7090*) Do not participate in this stratum % % Not meeting enrollment criteria % % No informed consent % % Logistic reasons % % Missed for enrollment 892 6% 436 6% No reason given 923 6% 450 6% * Number of completed forms

29 Conclusion Internal Validity Overall representativeness adequate: Some underrepresentation of older patients in core study Well balanced for gender and ISS

30 Age & Sex AGE - Core vs Registry AGE CORE REGISTRY Median (25-75 percentile) 50 (30-66) 55 (32-76) %>50 years 49.7% 55.7% Missing value 0 5 Total (N) SEX Core vs Registry SEX CORE REGISTRY Male (N/%) 2980 / 67.0% / 60.6% Female (N/%) 1467 / 33.0% 8561 / 39.4% Missing value 0 / 0.0% 2 / 0.0% Total (N)

31 TBI Is Changing Increasing Age In TBI Overview Of Observational Studies Study Traumatic Coma Data Bank (US) Year of study N Median age % > 50 yrs UK 4 Centre Study EBIC Core Data Survey (EU) POCON (The Netherlands) Austrian Severe TBI Study Italian ICU cohort CENTER-TBI Core data study Center TBI Registry

32 N patients N patients Distribution GCS SUM Score In ICU Stratum GCS Sum score numeric (ICU stratum) GCS Sum score numeric + non-numeric (ICU stratum) % 44% % 30% 32% % 200 9% GCS (3-8) GCS (9-12) GCS (13-15) 0 GCS (3-8) GCS (9-12) GCS (13-15) Non-numeric Dead Alive N % GCS (3-8) % GCS (9-12) % GCS (13-15) % Total % ICU stratum (N/%) Alive patients (N/%) Dead patients (N/%) GCS (3-8) 472 (28%) 341 (72%) 131 (28%) GCS (9-12) 156 (9%) 133 (85%) 23 (15%) GCS (13-15) 503 (30%) 474 (94%) 29 (6%) Non-numeric 531 (32%) 405 (76%) 126 (24%) Total 1662 (100%) 1353 (81%) 309 (19%)

33 Number Ct s Received By Icometrix Visit ADMISSION ER ICU Total CT Early CT Followup CT Post-Op Total Ct s With Completed Structured Reporting CT early CT follow up CT post op 73% 61% 51 % Current Recruitment: 5041

34 Number of patients Diff Between First CT And Injury Date/Time Time Difference between First CT and Injury First CT DateTimeSinceInj in hours

35 Imaging CT Repositories CT Early: 3326 CT Follow-up: 2454 CT Post-up: 379 Percentage of early CT s with completed structured reporting: 73% Biomarkers serum 36,575 aliquots from 2144 subjects banked in central bank Genetic Analysis Whole blood samples from 2026 TBI subjects banked Hemostasis examinations 1057 EDTA samples, 4438 aliquots citrate plasma Substudies Substudies MRI 614 Extended Coagulation 352 TEG/ROTEM 130 HR ICU 246 ECOG 4 Cont. EEG 28 Tahiti B 16

36 Understanding cause of injury Targeted prevention Fewer injuries, less severe injuries The International Initiative for Traumatic Brain Injury Research (InTBIR)

37 THE LANCET NEUROLOGY COMMISSION ON TBI

Definitions and epidemiology of TBI

Definitions and epidemiology of TBI International collaboration TBI is a global problem Brain Injury TODAY Keystone Symposia on Molecular and Cellular Biology Colorado Feb 26 March 2, 2012 Andrew Maas