inormus.foote.presentation ota2013 · abhay srivastava, jabalpur hospital and research centre,...
TRANSCRIPT
10/8/2013
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
10/8/2013
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 year1
10% of world’s deaths
UN report: 3rd largest killer by 20202
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): e27.
2. 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 year1
10% of world’s deaths
UN report: 3rd largest killer by 20202
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): e27.
2. WHO (2010). Injury Prevention and Safety Promotion - Urbanization and Health, Health in South East Asia, Vol. 3: 1-2.
10/8/2013
3
The EpicentreIndia
648,000 Major traumas
334,000 Accidental Deaths
Indian Bureau of Accidental Deaths Report 2009
1. 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. 2009. Delhi, India..
1. Bureau of Indian Accidental Deaths and Suicide. 2009. Delhi, India..
0
50000
100000
150000
200000
250000
300000
350000
400000
1967 1977 1987 1997 2000 2004 2005 2006 2007 2009
Death
s
Accidental Deaths in India
1. WHO, World Accident Resport 2013.
10/8/2013
4
Road Traffic Safety Decade
2011-2021
1.3 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
10/8/2013
5
The ProblemDeveloped nations data established
Developing Poor data on trauma
?Musculoskeletal trauma
THE SOLUTION :INORMUS
Large observational cohort study in India
across the entire subcontinent
10/8/2013
6
RationaleExplore 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 AimsPrimary
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
10/8/2013
7
Participating Hospitals
Eligibility
Skeletally mature
Fracture or dislocation (limbs, pelvis, or spine)
Hospital Types
Public
6 Hospitals
No medical Coverage
Commonly wards overcrowded
Conservative Management
Private
8 Hospitals
State of the art care
Mostly insured patients
10/8/2013
8
Sample SizeLogistic regression
Outcome: Death
Estimated Proportion: 2.5%
Model: 10 variables
Target = 4000 patients
Results
INORMUS exceeded defined sample size with 4612 patients
10/8/2013
9
5951 Screened
4822 Included
2400 Included in Analysis
2259 Included in Analysis
-392 skeletally immature
-737 minor injuries
2462 Public 2360 Private
16 missing fracture data
98 missing fracture
data
4612 Total
46 missing outcome data
3 missing outcome
data
Patients (n= 4612)Characteristic All Patients
Age (Yr)Mean ± Std
40.8 ± 16.9
Male 68.3%
Poverty* 8.7%
Injury locationRoad (%)
59.1%
MechanismMotorcycle 31.7%
Fracture 97.8%Open Fracture 15.0%
* Governmental Standards < 1000 USD/Year/family
Ambulance 30.1%
2/3 trauma patients transported by vehicles other than ambulances
Nonorthopedic injuries
Head injury 10.3%
Chest 9.6%
Abdomen 1.7%
10/8/2013
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 hoursAll 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%)
10/8/2013
11
ComplicationsOutcome Total
Mortality 1.7%, 95% CI: 1.4‐2.2%
Unplanned reoperation 6.0%95% CI: 5.4‐6.7%
Infection 6.1%95% CI: 5.6‐7.0%
Characteristic Rich Upper middle class
Lower middle Class
Poor p‐value
N 646 1050 1476 1103
Age(mean ± Std) 43.7 ± 17.7 41.2 ± 16.8 40.7 ± 16.7 38.9 ± 16.2 <0.001
Injury PlaceRoad/Street 377 (58.4%) 629 (59.9%) 881 (59.7%) 662 (60.0%) 0.91
Time from injury to hospital (hours) †< 24 hours24 – 72 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%)84 (7.6%)
0.02
Open Fracture 80 (12.4%) 132 (12.6%) 217 (14.7%) 232 (21.0%) <0.001
Time to irrigation and debridement ††< 6 hours 7‐12 hours13‐24 hours25‐48 hours 48 hours
50 (70.4%)12 (16.9%)9 (12.7%)00
85 (70.8%)18 (15.0%)10 (8.3%)4 (3.3%)3 (2.5%)
110 (55.0%)40 (20.0%)35 (17.5%)7 (3.5%)8 (4.0%)
107 (51.4%)38 (18.3%)45 (21.6%)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%) 0.004
20%
30%
Characteristic Road Accidents Other Mechanisms p-value
N 2742 (59.5%) 1870 (40.5%)
Age (years)Mean
38.0 ± 14.4 45.2 ± 19.2 <0.001
Gender (Male) 2071 (75.5%) 1087 (58.1%) <0.001
Number of fractures Dislocation only 1234 or more
42 (1.5%)2039 (74.4%)524 (19.1%)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 hours24 – 72 hours> 72 hours
2315 (84.8%)293 (10.7%)123 (4.5%)
1451 (78.8%)253 (13.7%)138 (7.5%)
<0.001
Outcomes at 30 days
Mortality 58 (2.1%) 19 (1.0%) 0.02
25%
15%
10/8/2013
12
Mortality: Rates & PredictorsCharacteristic Other Mechanisms Road Accidents p value
Unadjusted mortality rate
10.0 21.0 0.005
Mortality rate adjusted for risk factors †
17.0OR 1.0
35.2 (20.5 – 60.6)OR 2.1 (1.2 – 3.6)
0.008
Mortality rate adjusted for risk factors and orthopedic injury severity*
3.0OR 1.0
4.1 (2.3 – 6.9)OR 1.4 (0.8 – 2.4)
0.27
Mortality rate adjusted for nonorthopaedic injury‡
3.0OR 1.0
3.6 (2.1 ‐ 6.4)OR 1.2 (0.7 – 2.1)
0.51
Mortality rate adjusted for treatment factors§
0.01OR 1.0
0.01 (0.0 – 0.02)OR 1.1 (0.6 – 2.0)
0.75
Strength & WeaknessesWeaknessesPoor patients
Included hospitals
StrengthsRobust sample
Public/Private
Minimal data loss
Key FindingsA 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
10/8/2013
13
Global INORMUS Fracture Study
India Recruited extend to 10,000patients
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 !