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Clinical Database

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  1. 1. Clinical Database --From Basic to Application
  2. 2. Motivation How well did we do? From our experience, how is your operation risk?
  3. 3. Solution A: Past data B: Data analysis A + B = Clinical database!
  4. 4. Database Example 4
  5. 5. Data Variables (Computer) Text Number Date Administrative data
  6. 6. Data Variables (Epidemiology) X1, X2, ..., Xn -> Y Predictor: Xi Outcome: Y
  7. 7. Data Variables (Statistics) Scale: Continuous. eg. body weight Ordinal: Grading. eg. severity Nominal: Category. eg. side
  8. 8. Data Variables (Surgery) Demographics Baseline Preop Op Postop Outcome
  9. 9. Variable Definition Yes / No Timing Category Measurement
  10. 10. Database Example 10
  11. 11. Paperwork Question Chart review Paper writing Data key-in Analysis
  12. 12. Hospital Information System (HIS) Help from IT Variable definitions SQL (Structured Query Language) SELECT [X1], [X2] FROM [DB] WHERE [X3] ? [X4] Xi? DB?
  13. 13. Data Collection from HIS Diagnosis: ICD9 Operation: NHI Procedures: NHI IABP, MV, HD,... Drugs: ?
  14. 14. Cheng-Hsin General Hospital ICD-9 Codes and Diagnoses DM=250.* COPD=490-492.* or 496 PAOD=443.*-444.* CVA 434.91 or 434.11 or 997.02 Acute renal failure=584.* Chronic renal failure=586.*-588.* Critical=785.51 or shock or IABP or ECMO UA=413.* or angina LV dysfunction = 428.* or critical or CHF or ICMP AMI=410.* or AMI or infarction PHT=416.* or pulmonary hypertension IE=424.*
  15. 15. Cheng-Hsin General Hospital Natl Health Insurance Codes Operations Postop Course CABG*1= 68023 CABG+LIMA= 68023X1/2 CABG*2=68024 CABG*3=68025 MVA/TVA=68015 AVR/MVR/TVR=68016 DVR=68017 AVR+MVR+TVR=68018 Redo=68003 Ventilator=57001 IABP=33079 HD=58001 CVVH=58014 Text data-mining
  16. 16. Database Steps Data collection Data validation Data analysis
  17. 17. Interface: Data Entry V1, V2, ..., Vn Q1: V1 Q2: V2 Q3: V3
  18. 18. Data Analysis: Statistics Descriptive (): Tables, Graphs Inferential (): p-values
  19. 19. Inferential Statistics Different or not? Related or not? Predictor or not?
  20. 20. Different? Group Variable to compare
  21. 21. Related? Correlation Variable-1 Variable-2
  22. 22. Predictor? Predictor variables X1, X2,...Xn Outcome variable Y Scale Event (Y/N) Time-event
  23. 23. EuroScore Calculator http://www.euroscore.org Nashef SA et al: European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg 1999 Jul;16(1):9-13
  24. 24. EuroScore Calculator, Additive http://www.euroscore.org Nashef SA et al: European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg 1999 Jul;16(1):9-13
  25. 25. EuroScore Calculator, Logistic Nashef SA et al: European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg 1999 Jul;16(1):9-13 Roques F et al: The logistic EuroSCORE. Eur Heart J. 2003 May;24(9):882-3
  26. 26. EuroScore since 1995, 15 years old 36 Questions Patient details Patient Heart Operation Outcome EuroScore 2010
  27. 27. Commercial Package Interface Data Entry Data Analysis
  28. 28. Customization Which variables Possible questions
  29. 29. People Factors Work-flow Work-load Motivations
  30. 30. Cheng-Hsin General Hospital ICD-9 Codes and Diagnoses DM=250.* COPD=490-492.* or 496 PAOD=443.*-444.* CVA 434.91 or 434.11 or 997.02 Acute renal failure=584.* Chronic renal failure=586.*-588.* Critical=785.51 or shock or IABP or ECMO UA=413.* or angina LV dysfunction = 428.* or critical or CHF or ICMP AMI=410.* or AMI or infarction PHT=416.* or pulmonary hypertension IE=424.*
  31. 31. Cheng-Hsin General Hospital Natl Health Insurance Codes Operations Postop Course CABG*1= 68023 CABG+LIMA= 68023X1/2 CABG*2=68024 CABG*3=68025 MVA/TVA=68015 AVR/MVR/TVR=68016 DVR=68017 AVR+MVR+TVR=68018 Redo=68003 Ventilator=57001 IABP=33079 HD=58001 CVVH=58014 Text data-mining
  32. 32. Cheng-Hsin General Hospital Definition of Isolated CABG 1. CABG without any cardiac procedures such as valvular, aortic, Af ablation, etc. 2. Excluding redo-CABG 3. Not excluding pacemaker implantation or vascular procedures such as carotid endarterectomy or PAOD bypass.
  33. 33. Cheng-Hsin General Hospital Results: Overall From 2006-01-1 to 2008-12-31 CABG-included operations N=1066 Combined cardiac procedures: 22.0% Concomitant double-valve replacement, Bentalls operation, heart transplantation, redo, etc. 22% 78% N=1,066 Combined CABG only
  34. 34. Cheng-Hsin General Hospital Results: Isolated CABG Included Isolated CABG N=757 EuroScore (additive)= 3.1 (2.9~3.2) EuroScore (logistic)= 3.3% (2.9%~3.6%) Early graft failure: N=3 (0.4%) Redo CABG within the 3-year period On-pump arrest method: N=703 (92.9%) Off-pump or on-pump beating method: N=54 (7.1%)
  35. 35. Cheng-Hsin General Hospital On-pump Arrest CABGPreop Data First-time on-pump arrest CABG: N=703 EuroScore (additive)= 2.9 (2.7~3.1) EuroScore (logistic)= 3.0% (2.7%~3.2%) Female: 23.8% (20.6%~26.9%) Age at operation: 63.910.3 years (63.1~64.6) Concomitant carotid endarterectomy: 2.4% (1.3%~3.6%) Emergent: 8.7% (6.6%~10.8%) LM-involved disease: 16.1% (13.4%~18.8%).
  36. 36. Cheng-Hsin General Hospital On-pump Arrest CABG--Op Data LIMA use: 68.9% (65.4%~72.3%) No. of distal anastomosis: 3.71.0 (median=4, range=1~7) Op time : 8.01.5 hr (7.9~8.1) Pumping time: 135.044.2 min (131.7~138.3) Ischemic time: 83.230.0 min (81.0~85.4)
  37. 37. Cheng-Hsin General Hospital On-pump Arrest CABG--Postop Data New postop IABP: 2.7% (1.5%~3.9%) Lung complication (atelectasis infection): 9.5% (7.3%~11.7%) Reopen for bleeding: 1.9% (0.9%~2.8%) New-onset CVA (symptomatic): 2.3% (1.2%~3.4%) New-onset acute renal failure (hemodialysis): 3.7% (2.3%~5.1%)
  38. 38. Cheng-Hsin General Hospital On-pump Arrest CABG--Postop Data Surgical mortality (within 30 days): 1.6% (0.6%~2.5%) Hospital mortality (in the same in-hospital course): 1.9% (0.9%~2.8%) Excluding surgical mortality and postop CVA (N=703) Off ventilator within 24 hr: 67.1% (63.7%~70.6%) Median ICU stay: 5 days Median hospital stay: 15 days.
  39. 39. Cheng-Hsin General Hospital On-pump Arrest CABG--All- Cause Mortality Kaplan-Meier curve for freedom from all-cause mortality 1-year: 97.3% (95.7%~98.3%) 2-year: 96.8% (94.7%~98.1%) 3-year: 96.2% (93.6%~97.7%)
  40. 40. Cheng-Hsin General Hospital Variables for EuroScores Age Unstable angina Gender LV dysfunction COPD Recent MI PAOD Pulm. HTN CVA Redo Emergent op Renal insufficiency Combined proc. IE Op on thoracic Ao Preop critical Post. Infarct VSR
  41. 41. Fresh On-pump Arrest CABG-- All-Cause Mortality
  42. 42. Cheng-Hsin General Hospital Variables Included in the Regression Analyses EuroScore (additive) EuroScore (logistic) LM disease Carotid procedure Operation time Ischemia time Pumping time No. of distal anastomoses LIMA use (elective cases)
  43. 43. Cheng-Hsin General Hospital Predictors for Surgical Mortality (Within 30 Days) Predictor OR 95% CI P-value EuroScore (additive) 1.3 1.1~1.6 0.003 EuroScore (logistic)% 1.1 1.04~1.2 0.002
  44. 44. Cheng-Hsin General Hospital Predictors for Hospital Mortality (Same Hosp. Course) Predictor OR 95% CI P-value EuroScore (additive) 1.6 1.3~1.9