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CURE, HARM and GIM Academic ½ Day th October 24 2001 Dr Hui N. Lee, MD, M.Sc., FRCPC Community GIM, Sault Ste Marie Clinical Assistant Professor McMaster University Objectives Practical knowledge of current ACS management (October 2001) Overview of CURE study and role of clopidrogel in ACS therapy Principles of evaluation of Harm Understanding of Community GIM role Invitation for electives Up North Scenario 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 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 CURE (OASIS-4) Clopidogrel in Unstable Angina to prevent Recurrent ischemic Events Atherothrombosis: a Generalized and Progressive Process Normal Fatty streak Fibrous plaque Atherosclerotic plaque Plaque rupture/ fissure & thrombosis Unstable angina MI }ACS Ischemic stroke/TIA Critical leg ischemia Clinically silent Stable angina Intermittent claudication Increasing age ACS, acute coronary syndrome; TIA, transient ischemic attack Cardiovascular death Efficacy of Antiplatelet Therapy: Antiplatelet Trialists’ Collaboration Category of trial No. of trials with data MI, stroke, or vascular death Antiplatelet Adjusted controls Odds ratio and confidence interval (Antiplatelet: control) % odds reduction (SD) Prior MI 5% (4) 11 1331/9677 1693/9914 2 Acute MI 9% (4) 9 992/9388 1348/9385 2 18 1076/5837 1301/5870 7 182/1991 285/2027 Prior stroke/ 2% (4) TIA Unstable angina TIA, transient ischemic attack 0 0.5 1.0 Antiplatelet therapy better 1.5 2.0 Antiplatelet therapy worse 2 Antiplatelet Trialists’ Collaboration BMJ 1994;308:81–106 Complementary Mode of Action between Clopidogrel and ASA COX, cyclooxygenase; ADP, adenosine diphosphate; TxA2, thromboxane A2 Schafer AI Am J Med 1996;101:199–209 Trials of ADP-receptor Antagonists vs Placebo in Patients with Atherosclerosis Trial, Year Setting Primary Outcome Definitio n Thienopyridine (n/N) Odds Ratio 95% CI 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 CURE Study Investigators Eur Heart J 2000; 21: Trials of ADP-receptor Antagonists vs ASA in Patients with Atherosclerosis Trial, Year Setting Primary Outcome Definitio n Thienopyridine (n/N) Comparator (n/N) Odds Ratio 95% CI 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 1245/11128 1370/11126 0.90 0.83-0.97 TOTAL CURE Study Investigators Eur Heart J 2000; 21: ASA + Ticlopidine versus ASA after Coronary Artery Stenting Death or MI Study Odds Ratio 95% CI HALL, 1996 0.17 0.01-0.72 STARS, 1998* 0.25 0.10-0.63 0.23 0.11-0.49 TOTAL P=0.0001 Test for heterogeneity P=0.66 0.1 Combination Better 1.0 10.0 ASA Alone Better CURE Study Investigators Eur Heart J 2000; 21:2033 Study Design •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 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 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) 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) 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 Schedule Patients with Acute Coronary Syndrome R (UA or MI Without ST elevation) 300 mg loading + 75 mg o.d. dose Aspirin 75-325mg Clopidogrel (~6,250 patients) 3 months double-blind treatment 12 months Aspirin 75-325mg Placebo 1 tab o.d. (~6,250 patients) Baseline Characteristics (1) Placebo Clopidogrel N=6303 % 61.7 N=6259 % 61.3 Female 38.3 38.7 Unstable Angina 74.9 74.9 MI w/o ST Elevation Abnormal ECG 25.1 93.9 25.1 93.7 Elevated enzymes/marker 25.3 25.3 Male Baseline Characteristics (2) Placebo Clopidogrel Age N=6303 Mean (SD) 64.2 (11.3) N=6259 Mean (SD) 64.2 (11.3) Heart rate 73.0 (14.6) 73.2 (14.8) Systolic BP 134.1 (22.0) 134.4 (22.5) 14.1 (7.1) 14.2 (7.2) Symptom onset to randomization (hrs) Medications After Randomization in Hospital Placebo % 46.9 Clopidogrel % 46.0 LMW Heparin Beta-blocker 56.0 78.4 56.1 78.7 Any CCB ACE-I Lipid-lowering 36.0 49.9 47.0 36.0 50.9 46.3 IV Heparin Outcomes 1 /2 Plac Clop % % RR # Patients 1st Co-Primary CV Death MI Stroke Non CV death 6303 11.41 5.47 6.65 1.38 0.71 6259 9.30 5.08 5.18 1.20 0.66 0.80 0.93 0.77 0.86 0.91 CI p 0.72-0.90 0.79-1.08 0.67-0.89 0.63-1.18 0.60-1.39 < 0.001 0.03 0.04 0.05 Placebo 0.01 0.02 Clopidogrel P = 0.003 0.0 Cumulative Hazard Rates Rates Hazard Cumulative 0.06 Cumulative Hazard Rates for CV Death/MI/Stroke up to 30 Days 00 10 10 No. Plac6303 Days of Follow- 20 6108 upDays of Follow-up 5998 5957 No. Clop6259 6103 5984 20 6035 30 30 Placebo 0.10 0.08 0.06 0.02 0.04 Clopidogrel P < 0.001 0.0 Cumulative Hazard Rates Rates Hazard Cumulative 0.12 0.14 Cumulative Hazard Rates for CV Death/MI/Stroke 00 3 3 66 99 12 12 No of Pts Plac 6303 5780 4664 3600 2388 Clop 6259 5866 4779 3644 2418 Months of Follow-up Months of Follow-up Outcomes 2/2 # Patients 2nd Co-Primary Refract.Ischemia In hospital After Discharge Severe Ischemia Plac Clop % % RR CI p 6303 6259 18.83 16.5 0.86 0.79-0.94 < 0.001 4 9.31 8.69 0.93 0.82-1.04 2.00 1.36 0.68 0.52-0.90 7.59 7.57 0.99 0.87-1.13 5.03 3.80 0.75 0.63-0.89 < 0.001 Bleeding Complications Placebo Clopidogrel RR 95% CI p # Patients 6303 6259 Major Life Threatening 2.7% 1.8% 3.7% 2.2% 1.38 1.21 1.13-1.67 0.95-1.56 0.001 0.13 0.9% 1.5% 1.70 1.22-2.35 < 0.002 2.4% 2.2% 5.1% 2.8% 2.12 1.30 1.75-2.56 1.04-1.62 < 0.001 0.02 Other Major Minor Transfusion (2+Units) TIMI Major Bleeding / GUSTO Severe-LifeThreatening Bleeding Criteria Plac Clop 6303 6259 TIMI Criteria 73 (1.2%) GUSTO Criteria 70 (1.1%) # Patients RR (95% CI) P 68 (1.1%) 0.94 0.70 78 (1.2%) 1.12 0.48 Major/Life-Threatening Bleeds within 7 Days of CABG Surgery Plac Clop Stopped < 5 days prior N = 476 to CABG Pts with Maj/LT 6.3% Bleeds N = 436 Stopped > 5 days prior N = 454 to CABG Pts with Maj/LT 5.3% Bleeds N = 456 9.6% 4.4% RR p 1.53 0.06 0.83 0.53 Thrombocytopenia and Neutropenia Plac # Rand 6303 Thrombocytopenia 28 (0.44%) Neutropenia 5 (0.1%) Clop 6259 26 (0.42%) 8 (0.13%) Scenario 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 standard Do you stop Clopidogrel? Users’ Guides for an Article about 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 Designs Design Starting Point Assessment Strengths Weaknesses Cohort Exposure status Outcome event status Feasible when randomization not possible Susceptible to bias; limited validity CaseControl 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 generalizability Harm: Results and Applicability 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? Scenario 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 standard Do you stop Clopidogrel? Who would …. 1. Stop Clopidogrel? 2. Continue it? 3. Don’t know…. Clopidogrel: NNT and NNH Outcome ASA only ASA and Clopidogrel RRR ARR NNT or NNH Primary .114 .093 .20 (.10-.28) .021 47 Major Bleed .027 .037 .38 (.13-.67) .01 100 Clopidogrel: NNT and NNH Outcome ASA only ASA and Clopidogrel RRR ARR NNT or NNH Primary .114 .093 .20 (.10-.28) .021 47 Major Bleed .027 .037 .38 (.13-.67) .01 100 Minor Bleed .024 .051 1.12 (.75-1.56) .027 37 Clopidogrel: NNT and NNH Outcome ASA only ASA and Clopidogrel RRR ARR NNT or NNH Primary .114 .093 .20 (.10-.28) .021 47 Major Bleed .027 .037 .38 (.13-.67) .01 100 Minor Bleed .024 .051 1.12 (.75-1.56) .027 37 Our Patient ?? ?? .20 (.10-.28) ?? ?? TIMI Score for ACS www.timi.tv or www.timi.org 1. 2. 3. 4. 5. 6. 7. Age >= 65 years 3 CRF: (DM, HTN, Fam Hx, Lipid, smoker, ) Known CAD Prior chronic ASA use >= 2 episodes rest angina in 24h Elevated Cardiac enzymes ST deviation >= .5mm TIMI Score for ACS 1. 2. 3. 4. 5. 6. 7. Age >= 65 years 3 CRF: (DM, HTN, Fam Hx, Lipid, smoker, ) Known CAD Prior chronic ASA use >= 2 episodes rest angina in 24h Elevated Cardiac enzymes ST deviation >= .5mm TIMI clinical prediction score (14 days) TIMI Score Death/non-fatal MI Death/non-fatal MI/revascularization 0/1 3% 5% 2 3% 8% 3 5% 13% 4 7% 20% 5 12 26% 6/7 19 41% Clopidogrel: NNT and NNH Outcome ASA only ASA and Clopidogrel RRR ARR NNT or NNH Primary .114 .093 .20 (.10-.28) .021 47 (31-87) Major Bleed .027 .037 .38 (.13-.67) .01 100 Minor Bleed .024 .051 1.12 (.75-1.56) .027 37 TIMI 4 .07 [.056] [.20] [.014] [71] WHAT ARE THE CONFIDENCE INTERVALS AROUND NNT? Clopidogrel: NNT and NNH Outcome ASA only ASA and Clopidogrel RRR ARR NNT or NNH Primary .114 .093 .20 (.10-.28) .021 47 (31-87) Major Bleed .027 .037 .38 (.13-.67) .01 100 Minor Bleed .024 .051 1.12 (.75-1.56) .027 37 Our Patient TIMI 4 .07 .063 [.056] .10 [.20] .28 .007 [.014] 142 [71] Clopidogrel: NNT and NNH Outcome ASA only ASA and Clopidogrel RRR ARR NNT or NNH Primary .114 .093 .20 (.10-.28) .021 47 (31-87) Major Bleed .027 .037 .38 (.13-.67) .01 100 Minor Bleed .024 .051 1.12 (.75-1.56) .027 37 Our Patient TIMI 4 .07 .063 [.056] .05 .10 [.20] .28 .007 [.014] .02 142 [71] 51 Placebo 0.10 0.08 0.06 0.04 Clopidogrel 0.02 Initial benefit then 20% relative over 11 months P < 0.001 0.0 Cumulative HazardRates Rates Hazard Cumulative 0.12 0.14 Cumulative Hazard Rates for CV Death/MI/Stroke 00 3 3 66 99 12 12 No of Pts Plac 6303 5780 4664 3600 2388 Clop 6259 5866 4779 3644 2418 Months of Follow-up Months of Follow-up TIMI clinical prediction score (14 days) TIMI Score Death/non-fatal MI Death/non-fatal MI/revascularization 0/1 3% 5% 2 3% 8% 3 5% 13% 4 7% 20% 5 12 26% 6/7 19 41% Clopidogrel: NNT and NNH Outcome ASA only ASA and Clopidogrel RRR ARR NNT or NNH Primary .114 .093 .20 (.10-.28) .021 47 Major Bleed .027 .037 .38 (.13-.67) .01 100 Minor Bleed .024 .051 1.12 (.75-1.56) .027 37 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 Conservative Invasive 0-2 5% 5% 3-4 10% 7% 5-7 15% 12% TIMI and PRISM-PLUS TIMI UFH Tirofiban + UFH 0-2 6% 5% 3-4 9% 7% 5-7 15% 9% Non-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 GIM My History Community vs Tertiary Clinical Practice Research Teaching Lifestyle Options / Electives Tertiary 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. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. Primary Site Investigator, ESSENCE study (completed). 1993-4. Primary Site Investigator, GUSTO-III study (completed). 1994-5. Primary Site Investigator, PAT study (completed). 1995-7. Primary Site Investigator, OASIS-2 study (completed). 1995-7. Primary Site Investigator, SYMPHONY 1 study (completed). 1997-8. Primary Site Investigator, TAIS study (completed). 1995-8. Primary Site Investigator, SYMPHONY 2 study (completed). 1998-9. Primary Site Investigator, HOOD study (ongoing). 1993Primary Site Investigator, LITE/Home-LITE study (ongoing). 1995Primary Site Investigator, PEACE study (ongoing). 1996Primary Site Investigator, CURE study (completed). 1999-2001. Primary Site Investigator, CHARM study (ongoing). 1999Primary Site Investigator, GUSTO-IV study (ongoing). 1999Primary Site Investigator, WAVE study (ongoing). 2000Primary Site Investigator, EPHESUS study (ongoing). 2000Primary Site Investigator, PREVENT study (ongoing). 2000Primary Site Investigator, HOPE-TOO study (ongoing). 2000Primary Site Investigator, DREAM study (ongoing). 2001Primary Site Investigator, POISE study (ongoing). 2001Primary Site Investigator, INTERACT study (ongoing). 2001Primary Site Investigator, COMPETE-CHIPP project, McMaster University (ongoing). 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):16159;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). TEACHING Med students Family Medicine students GIM / Core IM electives and … NEW Northern Community GIM program starting July 2002 NEW Northern Ontario & Rural Medical School starting July 2004 Lifestyle Family – commitments to work Renumeration / quality of life Location: – – – – – Spousal employment Climate Safety Recreation Commuting Electives 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