10/8/2013. Lead Investigators: Mohit Bhandari, McMaster University, Canada Parag Sancheti, Sancheti Institute, Pune India

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1 Lead Investigators: Mohit Bhandari, McMaster University, Canada Parag Sancheti, Sancheti Institute, Pune India Methods and Coordinating- McMaster University Project Officers: Clary Foote MD, Mangesh Shende Data Management: Robert Ozolins, Clary Foote MD Statistics: Joseph Beyene PhD, Binod Neupene PhD Investigators Parag Sancheti, Steve Rocha, Chetan Pradhan, Sancheti Institute of Orthopaedics, Pune, India Vijay Shetty & Chintan Hegde, Hiranandani Hospital, Mumbai, India Prakash Kotwal, All Indian Institute Medical Sciences (AIIMS), Delhi, India Lakshminarayan, Sri Ramchandra University, Chennai, India Anil Jain, Guru Teg Bahadur (GTB) Hospital, Delhi, India Mandeep Dhillon & Sarvdeep Dhatt, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India Hitesh Gopalan, Medical Trust Hospital, Cochin, India Bobby John, Christian Medical College (CMC), Ludhiana, India Shantharam Shetty, Tejasvini Hospital, Mangalore, India Gurava Reddy, Sunshine Hospital, Hyderabad, India Avtar Singh, Amandeep Hospital, Amritsar, India Rajasekaran Shanmuganathan, Ganga Hospital, Coimbatore, India Abhay Srivastava, Jabalpur Hospital and Research Centre, Jabalpur, India Shrath Rao, University Hospital, Manipal, India 1

2 Funding and Disclosures Surgical Associates Foundation, McMaster University Regional Medical Associates, McMaster University HHS Trauma Research Fund, Hamilton, Ontario The authors have no financial interest, arrangement or affiliation with one or more organizations that could be perceived as a direct/indirect conflict of interest in the content of this presentation. The Problem Burden of Trauma 5.8 million people die per year 1 10% of world s deaths UN report: 3 rd largest killer by Disability > Death 1. Rodgers, A., Ezzati, M., Vander Hoorn, S., Lopez, A. D., Lin, R. B., & Murray, C. J. (2004). Distribution of major health risks: findings from the Global Burden of Disease study. PLoS Med, 1(1): e WHO (2010). Injury Prevention and Safety Promotion - Urbanization and Health, Health in South East Asia, Vol. 3: 1-2. The Problem Burden of Trauma 5.8 million people die per year 1 10% of world s deaths UN report: 3 rd largest killer by Disability > Death 1. Rodgers, A., Ezzati, M., Vander Hoorn, S., Lopez, A. D., Lin, R. B., & Murray, C. J. (2004). Distribution of major health risks: findings from the Global Burden of Disease study. PLoS Med, 1(1): e WHO (2010). Injury Prevention and Safety Promotion - Urbanization and Health, Health in South East Asia, Vol. 3:

3 The Epicentre India 648,000 Major traumas 334,000 Accidental Deaths Indian Bureau of Accidental Deaths Report WHO (2007). Injury Prevention and Care in the South-East Asia Region, Regional Meeting of National Programme Managers: 1, 12. Nonthaburi, Thailand: Sirindhorn National Medical Rehabilitation. 2. Bureau of Indian Accidental Deaths and Suicide Delhi, India Accidental Deaths in India Deaths Bureau of Indian Accidental Deaths and Suicide Delhi, India.. 1. WHO, World Accident Resport

4 Road Traffic Safety Decade Million deaths (90% Low Income countries) 51 Million major injuries WHO and United Nations Over 100 participating nations Indian Roads RTA 7.4 billion dollars Second highest 30 per 100,000 Burden of Fractures 4

5 The Problem Developed nations data established Developing Poor data on trauma?musculoskeletal trauma THE SOLUTION :INORMUS Large observational cohort study in India across the entire subcontinent 5

6 Rationale Explore determinants of outcomes Precise estimates of the growing burden of fractures Understand the contribution of specific injury mechanisms Identify potential discrepancies between hospital systems (e.g. timing of care, outcomes) Specific Aims Primary Predictors of Mortality Secondary (Descriptive) Access to primary trauma care Time to orthopaedic care Methods Recruitment of all patients presenting to emergency departments of hospitals in India with an orthopaedic injury over an 8 week period. Study sample: 4000 patients 6

7 Participating Hospitals Eligibility Skeletally mature Fracture or dislocation (limbs, pelvis, or spine) Hospital Types Public Private 6 Hospitals 8 Hospitals No medical Coverage Commonly wards overcrowded Conservative Management State of the art care Mostly insured patients 7

8 Sample Size Logistic regression Outcome: Death Estimated Proportion: 2.5% Model: 10 variables Target = 4000 patients Results INORMUS exceeded defined sample size with 4612 patients 8

9 5951 Screened 4822 Included -392 skeletally immature -737 minor injuries 2462 Public 2360 Private 16 missing fracture data 98 missing fracture data 46 missing outcome data 4612 Total 2400 Included in Analysis 2259 Included in Analysis 3 missing outcome data Patients (n= 4612) Characteristic All Patients Age (Yr) 40.8 ± 16.9 Mean ± Std Male 68.3% Poverty* 8.7% Injury location 59.1% Road (%) Mechanism Motorcycle 31.7% Fracture 97.8% Open Fracture 15.0% Ambulance 30.1% * Governmental Standards < 1000 USD/Year/family 2/3 trauma patients transported by vehicles other than ambulances Nonorthopedic injuries Head injury 10.3% Chest 9.6% Abdomen 1.7% 9

10 Orthopedic Injuries Fracture 97.8% Multiple fractures 18.7% Open fractures 15.1% Multiple open 2% Open Fractures (n=707) Grade I 22.4% II 31.9% III 45.9% IIIa 15.4% IIIb 17.1% IIIc 13.3% Time to Care Injury to admission > 24 hours All 18% (95% CI 16-20%) Open 12% (95% CI 9-15%) Delayed stabilization > 3 days 18% (95% CI 17-19%) Delayed irrigation & debridement >12 hours (n=707) 22% (95% CI 19-25%) 10

11 Complications Outcome Total Mortality 1.7%, 95% CI: % Unplanned reoperation 6.0% 95% CI: % Infection 6.1% 95% CI: % Characteristic Rich Upper middle Lower middle Poor class Class N p value Age (mean ± Std) 43.7 ± ± ± ± 16.2 <0.001 Injury Place Road/Street 377 (58.4%) 629 (59.9%) 881 (59.7%) 662 (60.0%) 0.91 Time from injury to hospital (hours) < 24 hours hours > 72 hours 541 (83.6%) 94 (14.6%) 10 (1.5%) 878 (84.3%) 118 (11.3%) 46 (4.4%) 1241 (84.2%) 154 (10.5%) 78 (5.3%) 879 (79.7%) 140 (12.7%) 20% 84 (7.6%) Open Fracture 80 (12.4%) 132 (12.6%) 217 (14.7%) 232 (21.0%) < Time to irrigation and debridement < 6 hours 50 (70.4%) 85 (70.8%) 110 (55.0%) 107 (51.4%) 7 12 hours 12 (16.9%) 18 (15.0%) 40 (20.0%) 38 (18.3%) hours 9 (12.7%) 10 (8.3%) 35 (17.5%) 45 (21.6%) 30% hours 48 hours (3.3%) 3 (2.5%) 7 (3.5%) 8 (4.0%) 12 (5.8%) 6 (2.9%) 0.02 Outcomes at 30 days Infection 26 (4.0%) 63 (6.0%) 95 (6.4%) 92 (8.3%) Characteristic Road Accidents Other Mechanisms p-value N 2742 (59.5%) 1870 (40.5%) Age (years) Mean 38.0 ± ± 19.2 <0.001 Gender (Male) 2071 (75.5%) 1087 (58.1%) <0.001 Number of fractures Dislocation only or more 42 (1.5%) 2039 (74.4%) 524 (19.1%) 25% 101 (3.7%) 36 (1.3%) 56 (3.0%) 1607 (85.9%) 171 (9.1%) 26 (1.4%) 10 (0.5%) <0.001 Open Fracture 568 (20.7%) 139 (7.4%) <0.001 Time from injury to hospital (hours) < 24 hours hours > 72 hours Outcomes at 30 days 2315 (84.8%) % (10.7%) 123 (4.5%) 1451 (78.8%) 253 (13.7%) 138 (7.5%) <0.001 Mortality 58 (2.1%) 19 (1.0%)

12 Mortality: Rates & Predictors Characteristic Other Mechanisms Road Accidents p value Unadjusted mortality rate Mortality rate adjusted for risk factors 17.0 OR ( ) OR 2.1 ( ) Mortality rate adjusted for risk factors and orthopedic injury severity* 3.0 OR ( ) OR 1.4 ( ) 0.27 Mortality rate adjusted for nonorthopaedic injury 3.0 OR ( ) OR 1.2 ( ) 0.51 Mortality rate adjusted for treatment factors 0.01 OR ( ) OR 1.1 ( ) 0.75 Strength & Weaknesses Weaknesses Poor patients Included hospitals Strengths Robust sample Public/Private Minimal data loss Key Findings A road traffic epidemic of MSK trauma Delayed hospital arrivals are common SES status predicts open fracture care Mortality is predicted by: Severity of orthopaedic and nonorthopaedic Access to care variables 12

13 Global INORMUS Fracture Study India Recruited extend to 10,000 patients Expansion of INORMUS into Latin America, China, Africa towards global target: 30,000 patients Partners: IGOT-UCSF for Latin America Thank you! Join us as an Investigator! 13