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P02 Reducing variations in care in the acute myocardial infarction (AMI) patient using medical practice guidelines
91s
Abstracts PO1 RANDOMIZATION SYSTEMS IN AN INTERNATIONAL MULTICENTRE CLINICAL TRIAL: THE CORE STUDY E. Santoro, E. Nicolii, M.G. Franzosi on behalf of GISSI Investigators ANMCO and lstituto “Mario Negri” Mihmo, ltaly
The Collaborative Organization for RheothRx Evaluation (CORE) is an international multicentre randomized clinical trial of 2984 patients with acute myocardial infarction enrolled between May 1994 and June 1995 in 225 Coronary Care Units (CCUs) distributed worldwide in 17 countries. Four Regional Data Coordinating Centres (RDCC) located in Canada, Europe, Argentina and Brazil were responsible for data management and central randomization. GISSI (Gruppo Italiino per lo studio della Sopravvivenza nell’Infarto miocardico) was the European RDCC and developed two randomization systems to provide a 24-hour randomization service (728 patients recruited in 77 centres located in 10 countries). The fist is a computerized network based randomization system: centres from four countries (Italy, Switzerland, Austria, Spain) were connected by local PC and a modem to the central computer located in the GISSI RDCC in Miino, Italy. The second is a PC based randomization software written in Visual Basic programming language for those countries (Hungary, Greece, Poland) where a connection by PC-modem was not feasible. In the first case, data were entered directly by the investigator and became immediately available on the central computer in Milano; in the second case data were entered by a local operator and sent weekly on floppy diik to GISSI RDCC. In both cases the software automatically validated data and checked the eligibility criteria before releasing the treatment allocation; a dynamic randomization algorithm based on the biased coin method has been implemented. A backup manual randomization by telephone was also available in case of computer systems failure. Randomization data were sent weekly from the GISSI RDCC to the International Coordinating Centre (Clinical Trial Methodology Centre, in Hamilton, Canada) be electronic mail. PO2 REDUCING VARIATIONS IN CARE IN THE ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT USING MEDICAL PRACTICE GUIDELINES James F. Reed, III, D. L. Morris and J. K. Rodgers The Pennsylvania State University College of Medicine and L-ehigh Valley Hospital AZlentown, Pennsylvania
The purpose of thii analysis is to demonstrate how national registry data may be used both in monitoring patient care and in designing an institutional specifii AMI care map that optimizes patient care. MetIm& A case report form (CRF) for each AM1 patient enrolled is completed by the nurse coordinator. The CRF contains pertinent patient data: demographics (racelethnicity, primary payor, medial history), event time
Abstracts lines (ie MI Sx onset, IV lytic ordered/initiated), presentation at the hospital (i.e. prehospital 12 lead ECGlresults, admission Dx, ftrst assessment of heart failure, nondiagnostic methods of MI Dx), initial reperfusion strategy, medications within 24 hours of MI Dx, patient outcomes (clinical events, stroke/intracranial bleed), MI location, MI type and discharge disposition. ReanItm Using the registry information a care map strategy has been formulated to optimize (reduce the variations) care received by the patient that presents to the emergency room with symptoms of chest pain. Using an initial evaluation (i.e. ECG, cardiac monitor, laboratory data, etc) patients are triaged into a low, intermediate, or hiih probability of AMI group. Each AMI probability group is subject to appropriate screening algorithms that have both absolute and relative contraindications for thrombolytic therapy, beta block contraindications, lidocaine use indications, right heart catheter indications, pacemaker indications, echocardiography indications, angiography indications, and EET indications. Conclusion: Participation in a national registry has facilitated the evaluation of AM1 management at our institution. Information is shared with hospital departments and divisions. PO3 DOSE TITRATION IN THE MULTICENTER STUDY OF HYDROXYUREA IN SICKLE CELL ANEMIA (MSH) C. Handy, F. Barton, R. Moore, R.P. McMahon, S. Eckert, M. Terrin, G. Dover, S. Charache and the MSH Investigators Maryland Medical Research Institute Baltimore, Maryland
In a double-blind, placebocontrolled clinical trial, daily hydroxyurea was titrated to stable doses in 152 pts. To maintain the blind, titration was simulated in the 147 placebo PL) patients. In HU pts, initial doses (15 mg/kg) were increased by 5 mg/kg every 12 weeks until toxicity (bone marrow depression) occurred. At toxicity, treatment was stopped briefly, reduced and thereafter adjusted in 2.5 mg/kg increments to final, stable doses or a specified maximum. Daily HU doses involved several different-sized capsules, and the number of capsules varied at each titration. Placebo (PL) pts were assigned to one of 14 computerized plans that simulated titration by including predetermined stops, modulating total doses and numbers of capsules, and stabilizing at final doses, as expected in the HU group based on the experience from a previous open-label study. During the course of the MSH, some placebo pts had their plans modified: to reduce final doses to levels lower than expected; for unexpected spontaneous toxicity in PL pts; and for missed visits coinciding with predetermined adjustments. The distributions of doses for HU and PL pts at study closeout (mean follow-up of 28 months, range 20-36 months) were similar (p=O.23). Among HU pts, 37% became toxic by 4 months and 63% by 8 months; 21% never became toxic. Among PL pts, 30% became toxic or were on a plan that simulated toxicity by 4 months, and 49% by 8 months; 37% were actually (spontaneously) toxic once and 25% had no dose adjustments for real or simulated toxicity. The distribution of final doses and the patterns of stops and dose adjustments were similar in HU and PL groups.
Abstracts PO1 RANDOMIZATION SYSTEMS IN AN INTERNATIONAL MULTICENTRE CLINICAL TRIAL: THE CORE STUDY E. Santoro, E. Nicolii, M.G. Franzosi on behalf of GISSI Investigators ANMCO and lstituto “Mario Negri” Mihmo, ltaly
The Collaborative Organization for RheothRx Evaluation (CORE) is an international multicentre randomized clinical trial of 2984 patients with acute myocardial infarction enrolled between May 1994 and June 1995 in 225 Coronary Care Units (CCUs) distributed worldwide in 17 countries. Four Regional Data Coordinating Centres (RDCC) located in Canada, Europe, Argentina and Brazil were responsible for data management and central randomization. GISSI (Gruppo Italiino per lo studio della Sopravvivenza nell’Infarto miocardico) was the European RDCC and developed two randomization systems to provide a 24-hour randomization service (728 patients recruited in 77 centres located in 10 countries). The fist is a computerized network based randomization system: centres from four countries (Italy, Switzerland, Austria, Spain) were connected by local PC and a modem to the central computer located in the GISSI RDCC in Miino, Italy. The second is a PC based randomization software written in Visual Basic programming language for those countries (Hungary, Greece, Poland) where a connection by PC-modem was not feasible. In the first case, data were entered directly by the investigator and became immediately available on the central computer in Milano; in the second case data were entered by a local operator and sent weekly on floppy diik to GISSI RDCC. In both cases the software automatically validated data and checked the eligibility criteria before releasing the treatment allocation; a dynamic randomization algorithm based on the biased coin method has been implemented. A backup manual randomization by telephone was also available in case of computer systems failure. Randomization data were sent weekly from the GISSI RDCC to the International Coordinating Centre (Clinical Trial Methodology Centre, in Hamilton, Canada) be electronic mail. PO2 REDUCING VARIATIONS IN CARE IN THE ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT USING MEDICAL PRACTICE GUIDELINES James F. Reed, III, D. L. Morris and J. K. Rodgers The Pennsylvania State University College of Medicine and L-ehigh Valley Hospital AZlentown, Pennsylvania
The purpose of thii analysis is to demonstrate how national registry data may be used both in monitoring patient care and in designing an institutional specifii AMI care map that optimizes patient care. MetIm& A case report form (CRF) for each AM1 patient enrolled is completed by the nurse coordinator. The CRF contains pertinent patient data: demographics (racelethnicity, primary payor, medial history), event time
Abstracts lines (ie MI Sx onset, IV lytic ordered/initiated), presentation at the hospital (i.e. prehospital 12 lead ECGlresults, admission Dx, ftrst assessment of heart failure, nondiagnostic methods of MI Dx), initial reperfusion strategy, medications within 24 hours of MI Dx, patient outcomes (clinical events, stroke/intracranial bleed), MI location, MI type and discharge disposition. ReanItm Using the registry information a care map strategy has been formulated to optimize (reduce the variations) care received by the patient that presents to the emergency room with symptoms of chest pain. Using an initial evaluation (i.e. ECG, cardiac monitor, laboratory data, etc) patients are triaged into a low, intermediate, or hiih probability of AMI group. Each AMI probability group is subject to appropriate screening algorithms that have both absolute and relative contraindications for thrombolytic therapy, beta block contraindications, lidocaine use indications, right heart catheter indications, pacemaker indications, echocardiography indications, angiography indications, and EET indications. Conclusion: Participation in a national registry has facilitated the evaluation of AM1 management at our institution. Information is shared with hospital departments and divisions. PO3 DOSE TITRATION IN THE MULTICENTER STUDY OF HYDROXYUREA IN SICKLE CELL ANEMIA (MSH) C. Handy, F. Barton, R. Moore, R.P. McMahon, S. Eckert, M. Terrin, G. Dover, S. Charache and the MSH Investigators Maryland Medical Research Institute Baltimore, Maryland
In a double-blind, placebocontrolled clinical trial, daily hydroxyurea was titrated to stable doses in 152 pts. To maintain the blind, titration was simulated in the 147 placebo PL) patients. In HU pts, initial doses (15 mg/kg) were increased by 5 mg/kg every 12 weeks until toxicity (bone marrow depression) occurred. At toxicity, treatment was stopped briefly, reduced and thereafter adjusted in 2.5 mg/kg increments to final, stable doses or a specified maximum. Daily HU doses involved several different-sized capsules, and the number of capsules varied at each titration. Placebo (PL) pts were assigned to one of 14 computerized plans that simulated titration by including predetermined stops, modulating total doses and numbers of capsules, and stabilizing at final doses, as expected in the HU group based on the experience from a previous open-label study. During the course of the MSH, some placebo pts had their plans modified: to reduce final doses to levels lower than expected; for unexpected spontaneous toxicity in PL pts; and for missed visits coinciding with predetermined adjustments. The distributions of doses for HU and PL pts at study closeout (mean follow-up of 28 months, range 20-36 months) were similar (p=O.23). Among HU pts, 37% became toxic by 4 months and 63% by 8 months; 21% never became toxic. Among PL pts, 30% became toxic or were on a plan that simulated toxicity by 4 months, and 49% by 8 months; 37% were actually (spontaneously) toxic once and 25% had no dose adjustments for real or simulated toxicity. The distribution of final doses and the patterns of stops and dose adjustments were similar in HU and PL groups.