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CURE, HARM and GIMCURE, HARM and GIMAcademic ½ DayAcademic ½ DayOctober 24October 24thth 2001 2001
Dr Hui N. Lee, MD, M.Sc., FRCPC
Community GIM, Sault Ste Marie
Clinical Assistant Professor McMaster University
ObjectivesObjectives
Practical knowledge of current ACS management (October 2001)
Overview of CURE study and role of clopidrogel in ACS therapy
Principles of evaluation of HarmUnderstanding of Community GIM roleInvitation for electives Up North
ScenarioScenario
67 year old man, non-Q MI with troponin I 8.2 / CK 300– Diabetes, HTN, dyslipidemia, ex-smoker– No previous MI or CAD, but GI bleed– Was on ASA, other standard meds
Now 3 days post MI– Rx ASA, clopidrogel, stop enoxaparin, other
Rx standard
Non-ST Elevation ACSNon-ST Elevation ACS
When do you add Clopidogrel? When do you stop Clopidogrel? How do you place Clopidogrel in relation to other
expensive/potentially risky interventions:– angiogram– LMW heparin– IV G2b3 inhibitors
Do you put Clopidogrel on formulary
CURECURE (OASIS-4)CURE (OASIS-4)
Clopidogrel in Unstable Angina to prevent
Recurrent ischemic Events
Atherothrombosis: a Generalized Atherothrombosis: a Generalized and Progressive Processand Progressive Process
NormalNormalFattyFattystreakstreak
FibrousFibrousplaqueplaque
Athero-Athero-scleroticscleroticplaqueplaque
PlaquePlaquerupture/rupture/fissure &fissure &
thrombosisthrombosis MIMI
IschemicIschemicstroke/TIA stroke/TIA
Critical leg Critical leg ischemiaischemia
Clinically silentClinically silent
CardiovascularCardiovasculardeathdeath
Increasing ageIncreasing age
Stable anginaStable anginaIntermittent claudicationIntermittent claudication
UnstableUnstableanginaangina}}ACSACS
ACS, acute coronary syndrome; TIA, transient ischemic attack
Efficacy of Antiplatelet Therapy:Efficacy of Antiplatelet Therapy:Antiplatelet Trialists’ CollaborationAntiplatelet Trialists’ Collaboration
Antiplatelet Trialists’ Collaboration BMJ 1994;308:81–106
Prior MIPrior MI 1111 1331/96771331/9677 1693/99141693/991425% (4)25% (4)
Acute MIAcute MI 99 992/9388992/9388 1348/93851348/938529% (4)29% (4)
Prior stroke/Prior stroke/ 1818 1076/58371076/5837 1301/58701301/587022% (4)22% (4)
TIATIA
Unstable angina Unstable angina 77 182/1991182/1991 285/2027285/2027
CategoryCategoryof trialof trial
No. ofNo. oftrialstrialswithwithdatadata
Anti-Anti-plateletplatelet
AdjustedAdjustedcontrolscontrols
Odds ratio andOdds ratio andconfidence intervalconfidence interval
(Antiplatelet:(Antiplatelet:control)control)
% odds% oddsreductionreduction
(SD)(SD)
MI, stroke, orMI, stroke, orvascular vascular
deathdeath
00 0.50.5 1.01.0 1.51.5 2.02.0
AntiplateletAntiplatelettherapytherapybetterbetter
AntiplateletAntiplatelettherapytherapyworseworse
TIA, transient ischemic attack
Complementary Mode of Action between Complementary Mode of Action between Clopidogrel and ASAClopidogrel and ASA
COX, cyclooxygenase; ADP, adenosine diphosphate; TxACOX, cyclooxygenase; ADP, adenosine diphosphate; TxA2, 2, thromboxane Athromboxane A2 2
Schafer AI Am J Med 1996;101:199–209
Trials of ADP-receptor Antagonists vs Trials of ADP-receptor Antagonists vs Placebo in Patients with AtherosclerosisPlacebo in Patients with Atherosclerosis
Trial, Year Setting Primary Outcome Odds Ratio
95% CI
Definition
Thieno-pyridine
(n/N)
Comparator (n/N)
Thienopyridine versus Placebo or Control
CATS 1989 (Ticlopidine vs Placebo
Recent Stroke
Death, MI,
Stroke
106/525 134/528 0.74 0.56-0.99
Balsano 1990 (Ticlopidine vs Control)
Unstable Angina
Death, MI
23/314 46/338 0.52 0.31-0.85
STIMS 1990 (Ticlopidine vs Placebo)
Intermittent Claudicatio
n
Death, MI,
Stroke
89/346 99/341 0.85 0.61-1.18
TOTAL 218/1185 279/1207 0.73 0.60-0.90CURE Study Investigators Eur Heart J 2000; 21: 2033-41.
Trials of ADP-receptor Antagonists vs ASA Trials of ADP-receptor Antagonists vs ASA in Patients with Atherosclerosis in Patients with Atherosclerosis
Trial, Year Setting Primary Outcome Odds Ratio
95% CI
Definition
Thieno-pyridine
(n/N)
Comparator (n/N)
Thienopyridine versus ASA
TASS, 1989 (Ticlopidine vs ASA)
Cerebral Ischemia
Death, Stroke
306/1529 349/1540 0.85 0.82-0.97
CAPRIE, 1996 (Clopidogrel vs ASA)
Recent Stroke,
Previous MI or PVD
Death, MI,
Stroke
939/9599 1021/9586 0.91 0.83-1.00
TOTAL 1245/11128
1370/11126 0.90 0.83-0.97
CURE Study Investigators Eur Heart J 2000; 21: 2033-41.
StudyStudy
HALL, 1996HALL, 1996
STARS, 1998*STARS, 1998*
TOTALTOTAL
0.10.1 1.01.0 10.010.0
Odds RatioOdds Ratio 95% CI95% CI
0.170.17 0.01-0.720.01-0.72
0.250.25 0.10-0.630.10-0.63
0.230.23 0.11-0.490.11-0.49
PP==0.00010.0001Test for heterogeneity Test for heterogeneity PP=0.66=0.66
ASA + Ticlopidine versus ASA after ASA + Ticlopidine versus ASA after Coronary Artery StentingCoronary Artery Stenting
Death or MIDeath or MI
CURE Study Investigators Eur Heart J 2000; 21:2033-41
Combination Better ASA Alone Better
•Randomized, double-blind, parallel group, clinical trial of clopidogrel vs placebo in patients with ACS
•All patients receive ASA (75-325 mg)
•International trial (28 countries)
•12,562 patients (482 Hospitals)
•Central randomization
•3-12 month Rx and follow-up
•Main outcomes: -CV death/MI, stroke
-Above + refractory ischemia
Study Design
Study ObjectivesStudy Objectives
To evaluate if clopidogrel is superior to placebo in preventing
a) CV death, MI, stroke (Primary at 0.045)
b) Above and refractory ischemia (Co-primary at 0.01)
Inclusion CriteriaInclusion Criteria
Ischemic symptoms, suspected to represent UA or MI without ST segment elevation
Randomized within 24 hours of onset of CP
and ECG evidence of ischemia at inclusion or already elevated cardiac enzymes or Troponin I or T to at least 2 x ULN*
* Prior to June 1999, pts > 60 yrs with normal ECG allowed
Revised July, 1999
Outcome Definitions (1/2)Outcome Definitions (1/2)CV Death: Excludes clear non-CV deaths
MI: Two of three usual criteria (CP, ECG or enzyme changes)
Stroke: Neurological deficit 24 hrs (CT/MRI encouraged)
Refractory Ischemia: Inhosp*: recurrent ischemia on max med Rx + ECG changes + intervention 1 day
After discharge: Rehosp for UA with ECG changes
Severe Ischemia*: Changes similar to in hospital Refractory Ischema, but no intervention
Recurrent Angina*: All other ischemic CP in hospital
Outcome Definitions (2/2)Outcome Definitions (2/2)
Major Bleeds: Significantly disabling, intraocular (vision loss), or transfusion of 2 units
Classified as Life Threatening if:
Hb > 5g/dl, hypotension needing IV inotropes, surgery to stop bleeding, symptomatic ICH or transfusion or 4 units of blood
Patient SchedulePatient Schedule
3 months double-blind treatment 12 months
Aspirin 75-325mg
Clopidogrel(~6,250 patients)
Placebo1 tab o.d.
(~6,250 patients)
Aspirin 75-325mgD
ay 1
6 m
. Vis
it9
m. V
isit
12 m
.
or F
inal
Vis
it
3 m
. Vis
it
Dis
char
ge V
isit
1 m
. Vis
it
Patients withAcute Coronary
Syndrome
(UA or MI Without STelevation)
R
load
ing
dose
300 mg loading + 75 mg o.d. dose
Baseline Characteristics (1)Baseline Characteristics (1)Placebo Clopidogrel
N=6303
%
N=6259
%
Male 61.7 61.3
Female 38.3 38.7
Unstable Angina 74.9 74.9
MI w/o ST Elevation 25.1 25.1
Abnormal ECG 93.9 93.7
Elevated enzymes/marker 25.3 25.3
Baseline Characteristics (2)Baseline Characteristics (2)Placebo Clopidogrel
N=6303
Mean (SD)
N=6259
Mean (SD)
Age 64.2 (11.3) 64.2 (11.3)
Heart rate 73.0 (14.6) 73.2 (14.8)
Systolic BP 134.1 (22.0) 134.4 (22.5)
Symptom onset to randomization (hrs) 14.1 (7.1) 14.2 (7.2)
Medications After Randomization Medications After Randomization in Hospitalin Hospital
Placebo Clopidogrel
% %
IV Heparin 46.9 46.0
LMW Heparin 56.0 56.1
Beta-blocker 78.4 78.7
Any CCB 36.0 36.0
ACE-I 49.9 50.9
Lipid-lowering 47.0 46.3
Outcomes 1 /2 Outcomes 1 /2 Plac Clop
% % RR CI p
# Patients 6303 6259
1st Co-Primary 11.41 9.30 0.80 0.72-0.90 < 0.001CV Death 5.47 5.08 0.93 0.79-1.08MI 6.65 5.18 0.77 0.67-0.89Stroke 1.38 1.20 0.86 0.63-1.18
Non CV death 0.71 0.66 0.91 0.60-1.39
Days of Follow-up
Cu
mu
lative
Ha
za
rd R
ate
s
0.0
0.0
10
.02
0.0
30
.04
0.0
50
.06
0 10 20 30
Cumulative Hazard Rates for CV Cumulative Hazard Rates for CV Death/MI/Stroke up to 30 DaysDeath/MI/Stroke up to 30 Days
P = 0.003
Clopidogrel
Placebo
Cum
ulat
ive
Haz
ard
Rat
es
Days of Follow-up
0 10 20 30
6303
6259
6108
6103
5998
6035
5957
5984
No. Plac
No. Clop
Months of Follow-up
Cu
mu
lative
Ha
za
rd R
ate
s
0.0
0.0
20
.04
0.0
60
.08
0.1
00
.12
0.1
4
0 3 6 9 12
Cumulative Hazard Rates for Cumulative Hazard Rates for CV Death/MI/StrokeCV Death/MI/Stroke
P < 0.001
Clopidogrel
Placebo
Cum
ulat
ive
Haz
ard
Rat
es
Months of Follow-up0 3 6 9 12
6303
6259
5780
5866
4664
4779
3600
3644
2388
2418
Plac
Clop
No of Pts
Outcomes 2/2Outcomes 2/2Plac Clop
% % RR CI p
# Patients 6303 6259
2nd Co-Primary 18.83 16.54
0.86 0.79-0.94 < 0.001
Refract.Ischemia 9.31 8.69 0.93 0.82-1.04
In hospital 2.00 1.36 0.68 0.52-0.90
After Discharge 7.59 7.57 0.99 0.87-1.13
Severe Ischemia 5.03 3.80 0.75 0.63-0.89 < 0.001
Bleeding ComplicationsBleeding ComplicationsPlacebo Clopidogrel RR 95% CI p
# Patients 6303 6259
Major 2.7% 3.7% 1.38 1.13-1.67 0.001Life Threatening
1.8% 2.2% 1.21 0.95-1.56 0.13
Other Major
0.9% 1.5% 1.70 1.22-2.35 < 0.002
Minor 2.4% 5.1% 2.12 1.75-2.56 < 0.001
Transfusion (2+Units)
2.2% 2.8% 1.30 1.04-1.62 0.02
TIMI Major Bleeding / GUSTO Severe-Life-TIMI Major Bleeding / GUSTO Severe-Life-Threatening Bleeding CriteriaThreatening Bleeding Criteria
Plac Clop RR
(95% CI)
P
# Patients 6303 6259
TIMI Criteria 73
(1.2%)
68 (1.1%)
0.94 0.70
GUSTO Criteria 70
(1.1%)
78
(1.2%)
1.12 0.48
Major/Life-Threatening Bleeds within 7 Major/Life-Threatening Bleeds within 7 Days of CABG SurgeryDays of CABG Surgery
Plac Clop RR p
Stopped < 5 days prior to CABG
N = 476 N = 436
Pts with Maj/LT Bleeds
6.3% 9.6% 1.53 0.06
Stopped > 5 days prior to CABG
N = 454 N = 456
Pts with Maj/LT Bleeds
5.3% 4.4% 0.83 0.53
Thrombocytopenia and Thrombocytopenia and NeutropeniaNeutropenia
Plac Clop
# Rand 6303 6259
Thrombocytopenia 28 (0.44%) 26 (0.42%)
Neutropenia 5 (0.1%) 8 (0.13%)
ScenarioScenario
67 year old man, non-Q MI Diabetes, HTN, dyslipidemia, ex-smoker
– No previous MI or CAD, but GI bleed– Was on ASA, other standard meds
Now 3 days post MI– Rx ASA, clopidogrel, stop enoxaparin, other
Rx standardDo you stop Clopidogrel?Do you stop Clopidogrel?
Users’ Guides for an Article Users’ Guides for an Article about Harmabout Harm
Are the results valid?– Similarity of all known determinants of
outcome or adjustments for differences in analysis?
– Were exposed patients equally identified?– Outcome assessment similar?– Was follow-up sufficiently complete?
Harm: Different Study DesignsHarm: Different Study DesignsDesignDesign Starting Starting
PointPointAssessmentAssessment StrengthsStrengths WeaknessesWeaknesses
Cohort Exposure status
Outcome event status
Feasible when randomization not possible
Susceptible to bias; limited validity
Case-Control
Outcome event status
Exposure status
Overcomes temporal delays; may only require small sample size
Susceptible to bias; limited validity
RCT Exposure status
Adverse event status
Lower susceptibility to bias
Feasibility and general-izability
Harm: Results and Harm: Results and ApplicabilityApplicability
What are the results?– How strong is the association between exposure and
outcome?– How precise is the estimate of the risk?
How can I apply the results to patient care?– Were the study patients similar to mine?– Was f/u duration adequate?– What is the magnitude of the risk?– Should I attempt to stop the exposure?
ScenarioScenario
67 year old man, non-Q MI Diabetes, HTN, dyslipidemia, ex-smoker
– No previous MI or CAD, but GI bleed– Was on ASA, other standard meds
Now 3 days post MI– Rx ASA, clopidogrel, stop enoxaparin, other
Rx standardDo you stop Clopidogrel?Do you stop Clopidogrel?
Who would ….Who would ….1.1. Stop Clopidogrel?Stop Clopidogrel?2.2. Continue it?Continue it?3.3. Don’t know….Don’t know….
Clopidogrel: NNT and NNHClopidogrel: NNT and NNHOutcomeOutcome ASA onlyASA only ASA andASA and
ClopidogrelClopidogrel
RRRRRR ARRARR NNT or NNT or NNHNNH
Primary .114 .093 .20
(.10-.28)
.021 47
MajorMajor
BleedBleed
.027.027 .037.037 .38 .38
(.13-.67)(.13-.67)
.01.01 100100
Clopidogrel: NNT and NNHClopidogrel: NNT and NNHOutcomeOutcome ASA onlyASA only ASA andASA and
ClopidogrelClopidogrel
RRRRRR ARRARR NNT or NNT or NNHNNH
Primary .114 .093 .20
(.10-.28)
.021 47
MajorMajor
BleedBleed
.027.027 .037.037 .38 .38
(.13-.67)(.13-.67)
.01.01 100100
Minor Minor BleedBleed
.024.024 .051.051 1.121.12
(.75-1.56)(.75-1.56)
.027.027 3737
Clopidogrel: NNT and NNHClopidogrel: NNT and NNHOutcomeOutcome ASA onlyASA only ASA andASA and
ClopidogrelClopidogrel
RRRRRR ARRARR NNT or NNT or NNHNNH
Primary .114 .093 .20
(.10-.28)
.021 47
MajorMajor
BleedBleed
.027.027 .037.037 .38 .38
(.13-.67)(.13-.67)
.01.01 100100
Minor Minor BleedBleed
.024.024 .051.051 1.121.12
(.75-1.56)(.75-1.56)
.027.027 3737
Our Patient ?? ?? .20
(.10-.28)
?? ??
TIMI Score for ACSTIMI Score for ACSwww.timi.tvwww.timi.tv or or www.timi.orgwww.timi.org
1. Age >= 65 years2. 3 CRF: (DM, HTN, Fam Hx, Lipid, smoker, )
3. Known CAD
4. Prior chronic ASA use
5. >= 2 episodes rest angina in 24h
6. Elevated Cardiac enzymes
7. ST deviation >= .5mm
TIMI Score for ACSTIMI Score for ACS1. Age >= 65 years2. 3 CRF: (DM, HTN, Fam Hx, Lipid, smoker, )
3. Known CAD
4. Prior chronic ASA use
5. >= 2 episodes rest angina in 24h
6. Elevated Cardiac enzymes
7. ST deviation >= .5mm
TIMI clinical prediction scoreTIMI clinical prediction score(14 days)(14 days)
TIMI ScoreTIMI Score Death/non-fatal MIDeath/non-fatal MI Death/non-fatal Death/non-fatal MI/revascularizationMI/revascularization
0/1 3% 5%
2 3% 8%
3 5% 13%
44 7%7% 20%20%
5 12 26%
6/7 19 41%
Clopidogrel: NNT and NNHClopidogrel: NNT and NNHOutcomeOutcome ASA onlyASA only ASA andASA and
ClopidogrelClopidogrel
RRRRRR ARRARR NNT or NNT or NNHNNH
Primary .114 .093 .20
(.10-.28)
.021 47
(31-87)
MajorMajor
BleedBleed
.027.027 .037.037 .38 .38
(.13-.67)(.13-.67)
.01.01 100100
Minor Minor BleedBleed
.024.024 .051.051 1.121.12
(.75-1.56)(.75-1.56)
.027.027 3737
TIMI 4 .07 [.056] [.20] [.014] [71]
WHAT ARE THE CONFIDENCE INTERVALS AROUND NNT?
Clopidogrel: NNT and NNHClopidogrel: NNT and NNHOutcomeOutcome ASA onlyASA only ASA andASA and
ClopidogrelClopidogrel
RRRRRR ARRARR NNT or NNT or NNHNNH
Primary .114 .093 .20
(.10-.28)
.021 47
(31-87)
MajorMajor
BleedBleed
.027.027 .037.037 .38 .38
(.13-.67)(.13-.67)
.01.01 100100
Minor Minor BleedBleed
.024.024 .051.051 1.121.12
(.75-1.56)(.75-1.56)
.027.027 3737
Our Patient
TIMI 4
.07 .063
[.056]
.10
[.20]
.28
.007
[.014]
142
[71]
Clopidogrel: NNT and NNHClopidogrel: NNT and NNHOutcomeOutcome ASA onlyASA only ASA andASA and
ClopidogrelClopidogrel
RRRRRR ARRARR NNT or NNT or NNHNNH
Primary .114 .093 .20
(.10-.28)
.021 47
(31-87)
MajorMajor
BleedBleed
.027.027 .037.037 .38 .38
(.13-.67)(.13-.67)
.01.01 100100
Minor Minor BleedBleed
.024.024 .051.051 1.121.12
(.75-1.56)(.75-1.56)
.027.027 3737
Our Patient
TIMI 4
.07 .063
[.056]
.05
.10
[.20]
.28
.007
[.014]
.02
142
[71]
51
Months of Follow-up
Cu
mu
lative
Ha
za
rd R
ate
s
0.0
0.0
20
.04
0.0
60
.08
0.1
00
.12
0.1
4
0 3 6 9 12
Cumulative Hazard Rates for Cumulative Hazard Rates for CV Death/MI/StrokeCV Death/MI/Stroke
P < 0.001
Clopidogrel
Placebo
Cum
ulat
ive
Haz
ard
Rat
es
Months of Follow-up0 3 6 9 12
6303
6259
5780
5866
4664
4779
3600
3644
2388
2418
Plac
Clop
No of Pts
Initial benefit then 20% relative over 11 months
TIMI clinical prediction scoreTIMI clinical prediction score(14 days)(14 days)
TIMI ScoreTIMI Score Death/non-fatal MIDeath/non-fatal MI Death/non-fatal Death/non-fatal MI/revascularizationMI/revascularization
0/1 3% 5%
2 3% 8%
3 5% 13%
44 7%7% 20%20%
5 12 26%
6/76/7 1919 41%41%
Clopidogrel: NNT and NNHClopidogrel: NNT and NNHOutcomeOutcome ASA onlyASA only ASA andASA and
ClopidogrelClopidogrel
RRRRRR ARRARR NNT or NNT or NNHNNH
Primary .114 .093 .20
(.10-.28)
.021 47
MajorMajor
BleedBleed
.027.027 .037.037 .38 .38
(.13-.67)(.13-.67)
.01.01 100100
Minor Minor BleedBleed
.024.024 .051.051 1.121.12
(.75-1.56)(.75-1.56)
.027.027 3737
Our Patient
TIMI 4
.07 .056 .20
(.10-.28)
.014
(.007-.02)
71
(51-142)
TIMI 6 .19 .15 .20
(.10-.28)
.04
(.019-.053)
25
(18-52)
TIMI in TACTICS (6mo)TIMI in TACTICS (6mo)
TIMITIMI ConservativeConservative InvasiveInvasive
0-20-2 5%5% 5%5%
3-43-4 10%10% 7%7%
5-75-7 15%15% 12%12%
TIMI and PRISM-PLUSTIMI and PRISM-PLUS
TIMITIMI UFHUFH Tirofiban + Tirofiban + UFHUFH
0-20-2 6%6% 5%5%
3-43-4 9%9% 7%7%
5-75-7 15%15% 9%9%
Non-ST Elevation ACSNon-ST Elevation ACS
When do you add Clopidogrel? When do you stop Clopidogrel? How do you place Clopidogrel in relation to other
expensive/potentially risky interventions:– angiogram– LMW heparin– IV G2b3 inhibitors
Do you put Clopidogrel on formulary
Community GIMCommunity GIM
My HistoryCommunity vs Tertiary Clinical PracticeResearchTeachingLifestyleOptions / Electives
Tertiary vs Community GIMTertiary vs Community GIM
Scut/hospitalist Few offices Few procedures Onerous Call Ponies and Horses Looked down by
subspecialists Access to journals
Consultant Office at least 50% Many choices Paid call as consultant Horses, Zebras and Gnus Valued by subspecialists
Full access to journals
CLINICAL RESEARCH PROJECTS Multicenter Studies: 1. Primary Site Investigator, ESSENCE study (completed). 1993-4.2. Primary Site Investigator, GUSTO-III study (completed). 1994-5.3. Primary Site Investigator, PAT study (completed). 1995-7.4. Primary Site Investigator, OASIS-2 study (completed). 1995-7.5. Primary Site Investigator, SYMPHONY 1 study (completed). 1997-8.6. Primary Site Investigator, TAIS study (completed). 1995-8.7. Primary Site Investigator, SYMPHONY 2 study (completed). 1998-9.8. Primary Site Investigator, HOOD study (ongoing). 1993- 9. Primary Site Investigator, LITE/Home-LITE study (ongoing). 1995-10. Primary Site Investigator, PEACE study (ongoing). 1996-11. Primary Site Investigator, CURE study (completed). 1999-2001.12. Primary Site Investigator, CHARM study (ongoing). 1999-13. Primary Site Investigator, GUSTO-IV study (ongoing). 1999-14. Primary Site Investigator, WAVE study (ongoing). 2000-15. Primary Site Investigator, EPHESUS study (ongoing). 2000-16. Primary Site Investigator, PREVENT study (ongoing). 2000-17. Primary Site Investigator, HOPE-TOO study (ongoing). 2000-18. Primary Site Investigator, DREAM study (ongoing). 2001-19. Primary Site Investigator, POISE study (ongoing). 2001-20. Primary Site Investigator, INTERACT study (ongoing). 2001-21. Primary Site Investigator, COMPETE-CHIPP project, McMaster University (ongoing). 22. Primary Site Investigator, ONTARGET/TRANSCEND
Funded Local Studies: Principal Investigator, GHC polypharmacy audit (PSI funding, $4000). Principal Investigator, GHC Diabetic Continuity of Care Study (CHSRF funding, $518,000 over three years). Principal Investigator, GHC/SAH applied research education grant (CHSRF funding, $30,000). Co-director, GHC Health Promotion Initiative Programs (GHC $122,000). Principal Investigator, CHF discharge transition project (PSI funding, $5600). Principal Co-Investigator, Northern Health Research Grant for determinants of cardiovascular disease in Sault Ste Marie 2000, (joint Lakehead, McMaster universities, $5000). Principal Investigator, Validation of the Osteoporosis Risk Assessment Index. (Proctor Gamble, $5000). Principal Investigator, Audit and Development of Atrial Fibrillation Risk Assessment Index. (Dupont, $5000). Principal Investigator, Optimization of Secondary Prevention of Cardiac Events in CAD, (Pfizer, $6000). Principal Investigator, Evidence Based Diabetes Lipids Management, (Merck, $5000). Co-Principal Investigator, Evaluating Teletriage in Northern Ontario. (Richard Ivey Foundation, $162,000).
PUBLICATIONS: 1992, 1994 Chief Editor: Survival Guide, McMaster University ... (Still published, fourth edition). 1. Heyland D., Cook D.J., Jaeschke R., Lee H.N., Griffith L., Guyatt G.G. Selective Decontamination of the Digestive Tract: An Overview. Chest 1994; 105:1221-9.2. Levine M, Walter S, Lee H, Haines T, Holbrook A, Moyer V. User’s Guides to the Medical Literature IV: How to use an article about harm. JAMA 271(20):1615-9;1994:May 25.3. User’s Guides Working Group, JAMA series 1993-1995.4. Lee HN, Cook DJ, Sarabia A, Hatala R, McCallum A, King D, Guyatt GH, Dobranowski J, Powers P. Inadequacy of intravenous heparin therapy in the initial management of venous thromboembolism. Journal of General Internal Medicine. 10(6):342-5, 1995 Jun. 5. Sauve H., Lee H.N. et al. The Critical Appraisal Topic: A Tool for Evidence Based Medicine. Ann R. College 1995.6. EBM Pocket Guide, Sault Ste Marie, 1997.7. EBM Workbook, Sault Ste Marie, 1997. Presented/Published Abstracts 1. Lee H.N., Cook D.J., Brill-Edwards P., Neville A. The Development of objective-linked behaviour-specific evaluation forms for residents on a clinical teaching unit. Clinical Research 1993;41(2):560A.2. Lee H.N., Lang J.D., Cook D.J. Characterization of Patient Care in a Medical Clinical Teaching Unit. Clinical Research 1993; 41(2):560A.3. Lee H.N., Ganesan C., Hatala R., Sarabia, McCallum A., Cook D.J. The initial management of venous thromboembolism: A study of factors leading to inadequate heparinization. Clinical Research 1993;41(2):543A.4. Lee H.N., Sauve J.S., Farkouh M.E., Sackett D.L. The Critically Appraised Topic: A standardized aid for the presentation and storage of evidence-based medicine. Clinical Research 1993; 41(2): 543A.5. Lee H.N., Churchill D, Adachi R.D., Thorpe K. Change in Lumbar spine bone mineral content of hemodialysis patients after parathyroidectomy. Clinical Research 1993;41(2):358A.6. Hunt D.L., Lee H.N., Sauve J.S., Farkouh M.E., Sackett D.L., Neural Network diagnosis of iron-deficiency anemia in the elderly: Comparison with conventional epidemiological methods. Clinical Research 1993;41(2):526A.7. Farkouh M.E., Sauve J.S., Kassam H., Lee H.N., Sackett D.L. Varying formats in which trial results are reported can affect clinical decision making. Clinical Research 1993;41(2):517A.8. Sauriol N, Lee HN. An audit of the acute management of myocardial infarction in a northern community. RCPSC Annual Meeting, Toronto, 1998.9. Catania A, Wallenius S, Lee HN. An audit of polypharmacy in a community health centre. Society of General Internal Medicine (SGIM) Annual Meeting, San Francisco, 1999.10. Olivier K, Lee HN. Utility of the Stress Test in a primary care setting. SGIM Annual Meeting, San Francisco, 1999.11. Shiau J, Wallenius S, Lee HN. A Randomized Controlled Trial of an Electronic Template to Improve Evidence Based Health Interventions in Patients with Diabetes. (SGIM, Boston 2000, CDA Annual Meeting, Halifax 2000).12. Lee HN for the CHIC investigators. SF-36 Quality of Life and association with Continuity of Care and Quality of Care in Diabetes. (CDA Annual Meeting, Halifax October 2000).13. Lee HN, Bragaglia P, Wetzl T, Apostolon C. A community-based registry of Adult Patients with Diabetes. (CDA Annual Meeting, Halifax, October 2000).14. Flintoft V, Lee HN, Sridhar F, Lee D. Systematic Review: Multidisciplinary Discharge Transition Programs decrease hospital readmission for heart failure patients. (SGIM Annual Meeting, San Diego, 2001).15. Chau, J, Lee HN. Balancing the Risks and Benefits of Anticoagulation in Elderly Patients with Atrial Fibrillation. (SGIM Annual Meeting, San Diego, 2001).16. Lee HN, Garniss D, Oliver R, McCullogh C, Dulisse D. A Community Hospital-Based Heart Failure Program Decreases Readmission Rates. (SGIM Annual Meeting, San Diego, 2001).
Lee HN, Wilson C, Ciaschini P, Hemy M, Mogharrabi V. Validation of the Osteoporosis Risk Assessment Index in the Community. (SGIM Annual Meeting, San Diego, 2001).
TEACHINGTEACHING
Med studentsFamily Medicine studentsGIM / Core IM electives and …NEW Northern Community GIM program
starting July 2002NEW Northern Ontario & Rural Medical
School starting July 2004
LifestyleLifestyle
Family – commitments to workRenumeration / quality of lifeLocation:
– Spousal employment– Climate– Safety– Recreation– Commuting
Electives and other optionsElectives and other options
Northern Specialty Electives– Paid travel, accommodations– Other residents– Free Internet and eJournal access– Families considered also
Northern Community GIM Residency– July 2002– advice