29 results on '"Booth FV"'
Search Results
2. Repletion of factor XIII following cardiopulmonary bypass using a recombinant A-subunit homodimer. A preliminary report.
- Author
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Levy JH, Gill R, Nussmeier NA, Olsen PS, Andersen HF, Booth FV, and Jespersen CM
- Subjects
- Adult, Aged, Anticoagulants adverse effects, Blood Coagulation drug effects, Blood Coagulation genetics, Factor XIII adverse effects, Factor XIII genetics, Female, Hemorrhage physiopathology, Humans, Male, Middle Aged, Protein Multimerization drug effects, Protein Multimerization genetics, Recombinant Proteins adverse effects, Recombinant Proteins genetics, Treatment Outcome, Anticoagulants administration & dosage, Cardiopulmonary Bypass, Factor XIII administration & dosage, Hemorrhage drug therapy, Hemorrhage etiology, Postoperative Complications, Recombinant Proteins administration & dosage
- Abstract
Bleeding following cardiac surgery involving cardiopulmonary bypass (CPB) remains a major concern. Coagulation factor XIII (FXIII) functions as a clot-stabilising factor by cross-linking fibrin. Low post-operative levels of FXIII correlate with increased post-operative blood loss. To evaluate preliminary safety and pharmacokinetics of recombinant FXIII (rFXIII-A(2)) in cardiac surgery, patients scheduled for coronary artery bypass grafting were randomised to receive a single dose of either rFXIII-A(2) (11.9, 25, 35 or 50 IU/kg) or placebo in a 4:1 ratio. Study drug was given post-CPB within 10 to 20 minutes after first protamine dose. Patients were evaluated until day 7 or discharge, with a follow-up visit at weeks 5-7. The primary end-point was incidence and severity of adverse events. Thirty-five patients were randomised to rFXIII-A(2) and eight to placebo. Eighteen serious adverse events were reported. These were all complications well recognised during cardiac surgery. Although one patient required an implantable defibrillator, all recovered without sequelae. One myocardial infarction in a patient receiving 35 IU/kg rFXIII-A(2) was identified by the Data Monitoring Committee after reviewing ECGs and cardiac enzymes. No other thromboembolic events were seen. Dosing with 25-50 IU/kg rFXIII-A(2) restored levels of FXIII to pre-operative levels, with a tendency towards an overshoot in receiving 50 IU/kg. rFXIII-A(2), in doses from 11.9 IU/kg up to 50 IU/kg, was well tolerated. For post-operative FXIII replenishment, 35 IU/kg of rFXIII-A(2) may be the most appropriate dose.
- Published
- 2009
- Full Text
- View/download PDF
3. Prophylactic heparin in patients with severe sepsis treated with drotrecogin alfa (activated).
- Author
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Levi M, Levy M, Williams MD, Douglas I, Artigas A, Antonelli M, Wyncoll D, Janes J, Booth FV, Wang D, Sundin DP, and Macias WL
- Subjects
- Aged, Anti-Infective Agents adverse effects, Anticoagulants adverse effects, Double-Blind Method, Drug Therapy, Combination, Drug-Related Side Effects and Adverse Reactions, Female, Heparin adverse effects, Humans, Male, Middle Aged, Protein C adverse effects, Recombinant Proteins administration & dosage, Recombinant Proteins adverse effects, Survival Analysis, Venous Thrombosis chemically induced, Anti-Infective Agents administration & dosage, Anticoagulants administration & dosage, Heparin administration & dosage, Protein C administration & dosage, Sepsis drug therapy, Venous Thrombosis prevention & control
- Abstract
Rationale: Patients with severe sepsis frequently receive prophylactic heparin during drotrecogin alfa (activated) (DrotAA) treatment due to risk of venous thromboembolic events (VTEs). Biological plausibility exists for heparin to reduce DrotAA efficacy and/or increase bleeding., Objectives: Primary: demonstrate in adult patients with severe sepsis receiving DrotAA treatment that 28-day mortality was equivalent for patients treated with concomitant prophylactic heparin compared with placebo; secondary: safety and VTE incidence., Methods: International, randomized, double-blind, phase 4, equivalence-design trial (n = 1994). Patients were eligible if indicated for and receiving DrotAA treatment under the country's approved label. Study drug (low molecular weight/unfractionated heparin) or placebo (saline) was administered every 12 hours during DrotAA infusion (24 ug/kg/hr for 96 hr). In patients on baseline heparin and randomized to placebo, heparin was stopped., Measurements and Main Results: Twenty-eight-day mortality was not equivalent between treatment groups. Heparin mortality was numerically lower (28.3 vs. 31.9%; p = 0.08). In the prospectively defined subgroup of patients exposed to heparin at baseline, patients receiving placebo experienced higher mortality (35.6 vs. 26.9%; p = 0.005). For safety, significant differences were observed during Days 0-6 for any bleeding event (placebo, n = 78; heparin, n = 105; p = 0.049) and ischemic stroke during Days 0-6 (placebo, n = 12; heparin, n = 3; p = 0.02) and Days 0-28 (placebo, n = 17; heparin, n = 5; p = 0.009). The VTE rate was low, with no statistical difference between groups (0-6 d, p = 0.60; 0-28 d, p = 0.26)., Conclusions: Compared with placebo, concomitant prophylactic heparin was not equivalent, did not increase 28-day mortality, and had an acceptable safety profile in patients with severe sepsis receiving DrotAA. Heparin discontinuation should be carefully weighed in patients considered for DrotAA treatment. XPRESS clinical trial registered with www.clinicaltrials.gov (NCT 00049777). The study ID numbers are 6743; F1K-MC-EVBR.
- Published
- 2007
- Full Text
- View/download PDF
4. International integrated database for the evaluation of severe sepsis and drotrecogin alfa (activated) therapy: analysis of efficacy and safety data in a large surgical cohort.
- Author
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Payen D, Sablotzki A, Barie PS, Ramsay G, Lowry S, Williams M, Sarwat S, Northrup J, Toland P, and Booth FV
- Subjects
- Aged, Anti-Infective Agents adverse effects, Female, Humans, Male, Middle Aged, Protein C adverse effects, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Retrospective Studies, Treatment Outcome, Anti-Infective Agents therapeutic use, Hemorrhage etiology, Protein C therapeutic use, Sepsis drug therapy
- Abstract
Background: The International Integrated Database for the Evaluation of Severe Sepsis and Drotrecogin alfa (activated) Therapy includes an extensive cohort of surgical patients (1659/4459; 37%). This database broadens the experience reported on a comparatively small set of surgical patients from the pivotal Protein C Worldwide Evaluation in Severe Sepsis trial to examine issues of safety and efficacy in a much larger cohort., Methods: We conducted a retrospective analysis of prospectively defined outcomes from 5 integrated clinical studies of severe sepsis. Multivariable analyses incorporated propensity scores, treatment, and significant baseline risk factors as independent variables in logistic regression models for 2 outcomes: serious adverse events that were observed during infusion and 28-day, all-cause mortality rates. Adjusted odds ratios were calculated for clinically important strata. Multiple subcategories of serious bleeding-event rates are presented., Results: Although surgical patients who were treated with drotrecogin alfa [activated] (DrotAA) experienced a greater proportion of serious bleeding events during the infusion period, most of the patients were treated without fatal consequence. A 10.7% absolute all cause mortality risk reduction (adjusted odds ratio, 0.66; 95% CI, 0.45-0.97) was observed for DrotAA-treated, high-risk (Acute Physiology and Chronic Health Evaluation II, >/= 25) surgical patients. We could not demonstrate a survival benefit in DrotAA-treated, low-risk (Acute Physiology and Chronic Health Evaluation II, <25) surgical patients. When surgical patients were stratified by number of organ dysfunctions, absolute risk reductions were observed in both categories: multiorgan (4.3%) and single (4.5%)., Conclusion: International Integrated Database for the Evaluation of Severe Sepsis and Drotrecogin alfa (activated) Therapy analyses affirmed the favorable benefit/risk profile of DrotAA for surgical patients. The serious adverse event rate that was experienced by surgical patients during the study drug infusion period was 7.5% in the DrotAA-treated group versus 6.3% in the placebo-treated group (odds ratio, 1.41; 95% CI, 0.89-2.25). The clinical benefit of DrotAA therapy paralleled baseline risk of death and substantiated findings from the Protein C Worldwide Evaluation in Severe Sepsis study. Future analyses are needed to evaluate the special relationships among sepsis severity, bleeding management, and the postoperative timing of DrotAA administration.
- Published
- 2007
- Full Text
- View/download PDF
5. International integrated database for the evaluation of severe sepsis and drotrecogin alfa (activated) therapy: analysis of efficacy and safety data in a large surgical cohort.
- Author
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Payen D, Sablotzki A, Barie PS, Ramsay G, Lowry S, Williams M, Sarwat S, Northrup J, Toland P, and McL Booth FV
- Subjects
- Adult, Aged, Anti-Infective Agents adverse effects, Female, Hemorrhage etiology, Humans, Logistic Models, Male, Middle Aged, Protein C adverse effects, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Treatment Outcome, Anti-Infective Agents therapeutic use, Databases as Topic, Protein C therapeutic use, Sepsis drug therapy, Surgical Procedures, Operative adverse effects
- Abstract
Background: The International Integrated Database for the Evaluation of Severe Sepsis and Drotrecogin alfa (activated) Therapy includes an extensive cohort of surgical patients (1659/4459; 37%). This database broadens the experience reported on a comparatively small set of surgical patients from the pivotal Protein C Worldwide Evaluation in Severe Sepsis trial to examine issues of safety and efficacy in a much larger cohort., Methods: We conducted a retrospective analysis of prospectively defined outcomes from 5 integrated clinical studies of severe sepsis. Multivariable analyses incorporated propensity scores, treatment, and significant baseline risk factors as independent variables in logistic regression models for 2 outcomes: serious adverse events that were observed during infusion and 28-day, all-cause mortality rates. Adjusted odds ratios were calculated for clinically important strata. Multiple subcategories of serious bleeding-event rates are presented., Results: Although surgical patients who were treated with drotrecogin alfa [activated] (DrotAA) experienced a greater proportion of serious bleeding events during the infusion period, most of the patients were treated without fatal consequence. A 10.7% absolute all cause mortality risk reduction (adjusted odds ratio, 0.66; 95% CI, 0.45-0.97) was observed for DrotAA-treated, high-risk (Acute Physiology and Chronic Health Evaluation II, >or=25) surgical patients. We could not demonstrate a survival benefit in DrotAA-treated, low-risk (Acute Physiology and Chronic Health Evaluation II, <25) surgical patients. When surgical patients were stratified by number of organ dysfunctions, absolute risk reductions were observed in both categories: multiorgan (4.3%) and single (4.5%)., Conclusion: International Integrated Database for the Evaluation of Severe Sepsis and Drotrecogin alfa (activated) Therapy analyses affirmed the favorable benefit/risk profile of DrotAA for surgical patients. The serious adverse event rate that was experienced by surgical patients during the study drug infusion period was 7.5% in the DrotAA-treated group versus 6.3% in the placebo-treated group (odds ratio, 1.41; 95% CI, 0.89-2.25). The clinical benefit of DrotAA therapy paralleled baseline risk of death and substantiated findings from the Protein C Worldwide Evaluation in Severe Sepsis study. Future analyses are needed to evaluate the special relationships among sepsis severity, bleeding management, and the postoperative timing of DrotAA administration.
- Published
- 2006
- Full Text
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6. Application of a population-based severity scoring system to individual patients results in frequent misclassification.
- Author
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Booth FV, Short M, Shorr AF, Arkins N, Bates B, Qualy RL, and Levy H
- Subjects
- Epidemiologic Methods, Humans, APACHE, Health Status, Sepsis classification
- Abstract
Introduction: APACHE II (AP2) was developed to allow a systematic examination of intensive care unit outcomes in a risk adjusted manner. AP2 has been widely adopted in clinical trials to assure broad consistency amongst different groups. Although errors in calculating the true AP2 score may not be reducible below 15%, the self-canceling effect of random errors reduces the importance of such errors when applied to large populations. It has been suggested that a threshold AP2 score be used in clinical decision making for individual patients. This study reports the AP2 scoring errors of researchers involved in a large sepsis trial and models the consequences of such an error rate for individual severe sepsis patients., Methods: Fifty-six researchers with explicit training in data abstraction and completion of the AP2 score received scenarios consisting of composites of real patient histories. Descriptive statistics were calculated for each scenario. The standard deviations were calculated compared with an adjudicated score. Intraclass correlations for inter-observer reliability were performed using Shrout-Fleiss methodology. Theoretical distribution curves were calculated for a broad range of AP2 scores using standard deviations of 6, 9 and 12. For each curve, the misclassification rate was determined using an AP2 score cut-off of >or=25. The percentage of misclassifications for each true AP2 score was then applied to the corresponding AP2 score obtained from the PROGRESS severe sepsis registry., Results: The error rate for the total AP2 score was 86% (individual variables were in the range 10% to 87%). Intraclass correlation for the inter-observer reliability was 0.51. Of the patients from the PROGRESS registry. 50% had AP2 scores in the range 17 to 28. Within this interquartile range, 70% to 85% of all misclassified patients would reside., Conclusion: It is more likely that an individual patient will be scored incorrectly than correctly. The data obtained from the scenarios indicated that as the true AP2 score approached an arbitrary cut-off point of 25, the observed misclassification rate increased. Integrating our study of AP2 score errors with the published literature leads us to conclude that the AP2 is an inappropriate sole tool for resource allocation decisions for individual patients.
- Published
- 2005
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7. Safety of drotrecogin alfa (activated) in surgical patients with severe sepsis.
- Author
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Fry DE, Beilman G, Johnson S, Williams MD, Rodman G, Booth FV, Bates BM, McCollam JS, and Lowry SF
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- Dose-Response Relationship, Drug, Drug Administration Schedule, Evaluation Studies as Topic, Female, Hemorrhage chemically induced, Hemorrhage epidemiology, Humans, Infusions, Intravenous, Male, Probability, Prognosis, Prospective Studies, Protein C adverse effects, Recombinant Proteins adverse effects, Retrospective Studies, Risk Assessment, Sepsis diagnosis, Sepsis mortality, Severity of Illness Index, Surgical Procedures, Operative adverse effects, Surgical Procedures, Operative methods, Surgical Wound Infection mortality, Survival Analysis, Treatment Outcome, Protein C administration & dosage, Recombinant Proteins administration & dosage, Sepsis drug therapy, Surgical Wound Infection diagnosis, Surgical Wound Infection drug therapy
- Abstract
Background: We conducted a retrospective evaluation of the overall safety of drotrecogin alfa (activated) in surgical patients with severe sepsis enrolled in PROWESS., Methods: A blinded Surgical Evaluation Committee (SEC) verified surgical patients as having undergone a significant operative procedure within 30 days prior to enrollment. Serious and treatment-emergent bleeding events, both during the study drug infusion period (120 h) and the entire 28-day study period were analyzed by surgical status and by treatment assignment. Statistical analysis was performed using Fisher's exact test., Results: Serious bleeding rates during infusion in the surgical patients were 3.1% (7/228) and 0% (0/246) in the drotrecogin alfa (activated) and placebo groups, respectively (p = 0.006). Treatment-emergent bleeding rates during infusion in the surgical patients were 16.7% (38/228) and 7.7% (19/246) in the drotrecogin alfa (activated) and placebo groups, respectively (p = 0.003). None of the treatment-emergent bleeding events was fatal. Of seven drotrecogin alfa (activated) serious bleeding events, six were procedure-related. The serious bleeding rates within each treatment group were statistically indistinguishable between the medical and surgical patients. However, the medical patients had numerically higher treatment-emergent bleeding rates than the surgical patients within each treatment group. Despite this observation, overall surgical patients received more transfusions of red blood cells, of platelets, and of fresh frozen plasma than their medical counterparts., Conclusions: Although treatment of surgical patients with drotrecogin alfa (activated) for severe sepsis is associated with a higher incidence of serious bleeding and subsequent treatment- emergent bleeding events, the magnitude of this increase is small and clinically acceptable.
- Published
- 2004
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8. Computerized physiologic monitoring.
- Author
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Booth FV
- Subjects
- Computer Systems, Humans, Medical Laboratory Science instrumentation, Monitoring, Physiologic methods, Critical Care methods, Medical Informatics Computing, Medical Laboratory Science trends, Monitoring, Physiologic instrumentation
- Abstract
Computers can offer significant enhancement to the monitoring of the critically ill. Their value is derived from improved vigilance, better charting, and an opportunity to assess practitioner compliance with unit protocols. However, their true value can only be attained when they are integrated into a total information system.
- Published
- 1999
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9. Clinical and economic outcome of mechanically ventilated patients in New York State during 1993: analysis of 10,473 cases under DRG 475.
- Author
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Kurek CJ, Dewar D, Lambrinos J, Booth FV, and Cohen IL
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- Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Costs and Cost Analysis, Databases as Topic, Diagnosis-Related Groups economics, Female, Health Facilities, Home Care Services, Humans, Male, Medicaid economics, Middle Aged, New York, Outcome Assessment, Health Care economics, Patient Discharge, Residential Facilities, Retrospective Studies, Survival Rate, Treatment Outcome, United States, Respiration, Artificial economics
- Abstract
Study Objectives: To examine and describe the relationship between age and disposition in patients undergoing mechanical ventilation., Design: Retrospective analysis of a statewide database., Setting: All acute-care hospitals in New York State., Patients: All patients (n=10,473) aged > or = 18 years discharged from hospital during 1993 with a final diagnosis related group (DRG) coding of 475., Interventions: None., Measurements and Results: The final disposition, according to six codes (other acute-care facility, residential health-care facility, other health-care facility, home, home health-care services, and death) were examined for the whole population. Cost per case was assumed to equal the average statewide Medicaid rate. An inverse relationship between survival rate and age was observed and this resulted in an age-related increased cost per survivor. Also, survivors in older age groups have an increasing rate of hospital discharge to residential health-care facilities., Conclusion: Patients who undergo mechanical ventilation are expensive to care for. The older they are, the less satisfactory is the outcome both from clinical and economic perspectives.
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- 1998
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10. Screening for asymptomatic deep vein thrombosis in surgical intensive care patients.
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Harris LM, Curl GR, Booth FV, Hassett JM Jr, Leney G, and Ricotta JJ
- Subjects
- APACHE, Adolescent, Adult, Aged, Aged, 80 and over, Algorithms, Female, Humans, Intensive Care Units, Length of Stay, Male, Middle Aged, Regression Analysis, Risk Factors, Thrombophlebitis complications, Ultrasonography, Doppler, Duplex, Thrombophlebitis diagnostic imaging
- Abstract
Purpose: To identify the presence of occult deep vein thrombosis (DVT) in surgical intensive care unit (SICU) patients and to avoid unnecessary screening, we reviewed our experience with routine duplex screening for DVT in SICU patients., Methods: Over a 24-month period, all patients who were admitted to an SICU with an anticipated length of stay greater than 36 hours were studied to determine the prevalence of risk factors for asymptomatic proximal DVT. Risk factors, demographics, and operative data were collected and analyzed with multilinear regression, t tests and chi 2 analysis., Results: There was a 7.5% prevalence of major DVT in the 294 patients studied. APACHE II scores (14.5 +/- 6.24 vs 10.3 +/- 3.15; p < 0.0001) and emergent procedures (45.5% vs 23.2%; p > 0.0344) were associated with DVT by multifactorial analysis. Age was significant by univariate analysis. An algorithm based on the presence of any one of the three risk factors identified (APACHE II score 12 or more; emergent procedures; or age 65 or greater) could be used to limit screening by 30% while achieving a 95.5% sensitivity for identification of proximal DVT., Conclusion: Absence of all three risk factors indicates a very low risk for DVT (1.1%). Screening of SICU patients is indicated because of a high prevalence of asymptomatic disease. Patients who have proximal DVT require active therapy and not prophylaxis. Costs and resources may be contained by using the above risk factors as a filter for duplex screening.
- Published
- 1997
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11. Clinical and economic outcome of patients undergoing tracheostomy for prolonged mechanical ventilation in New York state during 1993: analysis of 6,353 cases under diagnosis-related group 483.
- Author
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Kurek CJ, Cohen IL, Lambrinos J, Minatoya K, Booth FV, and Chalfin DB
- Subjects
- Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Economics, Medical, Humans, Insurance, Health, Reimbursement, Middle Aged, New York, Retrospective Studies, Survival Rate, Diagnosis-Related Groups, Tracheostomy, Ventilators, Mechanical
- Abstract
Objective: To examine and describe the relation between age and disposition in patients undergoing tracheostomy., Design: Retrospective analysis of a statewide database., Setting: All acute care hospitals in New York state., Patients: All patients (n = 6,353) > or = 18 yrs of age who were discharged from the hospital during 1993 with a final diagnosis-related groups code of 483., Interventions: None., Measurements and Main Results: The final disposition, according to six disposition codes (other acute care facility, residential healthcare facility, other healthcare facility, home, home healthcare services, and death) was examined for the entire population. Cost per case was assumed to equal the average statewide Medicaid rate. An inverse relation between survival rate and age was observed, which resulted in an age-related increased cost per survivor. Also, survivors in older age groups had an increased rate of discharge to residential healthcare facilities. There was a negative, albeit less marked, effect of older age on the rates of survivors discharged to home and to other healthcare facilities., Conclusions: Care of patients who undergo tracheostomy for prolonged mechanical ventilation is expensive. The older the patient, the less satisfactory the outcome from an economic, clinical, and possibly social perspective.
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- 1997
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12. Barotrauma complicating duodenal perforation during ERCP.
- Author
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Doerr RJ, Kulaylat MN, Booth FV, and Corasanti J
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- Aged, Aged, 80 and over, Female, Humans, Barotrauma etiology, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Duodenal Diseases complications, Intestinal Perforation complications
- Abstract
Diagnostic endoscopic retrograde cholangiopancreatography (ERCP) is a remarkably safe procedure in experienced hands. A series of complications directly related to both the manipulation and cannulation of the ampulla of Vater, as well as consequent to medication and cardiorespiratory events, has been described. Herein we report a case of severe barotrauma complication of diagnostic endoscopic cholangiography.
- Published
- 1996
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13. Critical care medicine: opportunities and strategies for improvement.
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Cohen IL, Fitzpatrick M, and Booth FV
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- Institutional Management Teams organization & administration, Outcome and Process Assessment, Health Care organization & administration, Patient Care Team organization & administration, Triage organization & administration, United States, Critical Care organization & administration, Total Quality Management methods
- Abstract
Background: Like other areas of health care, critical care faces increasing pressure to improve the quality while reducing the cost of care. Strategies drawn from the literature and the authors' experiences are presented., Strategies and Opportunities for Improvements: Ten process- or structure-related areas are targeted as strategically important focuses of improvement: (1) restructuring administrative lines to better suit key processes; (2) physician leadership in critical care units; (3) management training for critical care managers; (4) triage; (5) multidisciplinary critical care; (6) standardization of care; (7) developing alternatives to critical care units; (8) timeliness of care delivery; (9) appropriate use of critical care resources; and (10) tracking quality improvement., Timeliness of Care Delivery: Whatever the root cause(s) of unnecessary delays, the result is inefficient use of critical care resources-and ultimately either a need for more resources or longer wait times. Innovations designed to reduce wait times and waste, such as the establishment of a microchemistry stat laboratory, may prove valuable., Appropriate Use of Critical Care Resources: Possible strategies for the appropriate use of critical care resources include better selection of well-informed patients who undergo procedures. Reduction in variation among physicians and organizations in providing therapies will also likely lead to a reduction in some high-risk procedures offering little or no benefit, and therefore a reduction in need for critical care services. Better preparation of patients and families should also make end-of-life decisions easier when questions of "futility" arise. Better information on outcomes and cost-effectiveness and consensus on withdrawal of critical care treatments represent two additional strategies.
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- 1996
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14. On developing careers in trauma and surgical care: report of the ad hoc committee on careers in trauma surgery, Eastern Association for the Surgery of Trauma.
- Author
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Shackford SR, Gabram SG, Rozycki GS, Rutherford EJ, Johnson SB, Kauder DA, Miller FB, Trask AL, Booth FV, and Zeppa R
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- Acquired Immunodeficiency Syndrome transmission, Attitude of Health Personnel, Humans, Infectious Disease Transmission, Patient-to-Professional, Liability, Legal, Physician-Patient Relations, Career Choice, General Surgery education, Traumatology education
- Published
- 1994
15. Cost containment and mechanical ventilation in the United States.
- Author
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Cohen IL and Booth FV
- Subjects
- Clinical Protocols, Diagnosis-Related Groups economics, Health Services Needs and Demand, Home Care Services economics, Humans, Intermediate Care Facilities economics, Inventories, Hospital economics, Length of Stay economics, Patient Care Team, Rehabilitation economics, Reimbursement Mechanisms economics, Respiration, Artificial statistics & numerical data, Total Quality Management economics, United States, Cost Control methods, Intensive Care Units economics, Respiration, Artificial economics
- Abstract
In many ICUs, admission and discharge hinge on the need for intubation and ventilatory support. As few as 5% to 10% of ICU patients require prolonged mechanical ventilation, and this patient group consumes > or = 50% of ICU patient days and ICU resources. Prolonged ventilatory support and chronic ventilator dependency, both in the ICU and non-ICU settings, have a significant and growing impact on healthcare economics. In the United States, the need for prolonged mechanical ventilation is increasingly recognized as separate and distinct from the initial diagnosis and/or procedure that leads to hospitalization. This distinction has led to improved reimbursement under the prospective diagnosis-related group (DRG) system, and demands more precise accounting from healthcare providers responsible for these patients. Using both published and theoretical examples, mechanical ventilation in the United States is discussed, with a focus on cost containment. Included in the discussion are ventilator teams, standards of care, management protocols, stepdown units, rehabilitation units, and home care. The expanding role of total quality management (TQM) is also presented.
- Published
- 1994
16. ABCs of quality assurance.
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Booth FV
- Subjects
- Humans, Joint Commission on Accreditation of Healthcare Organizations, United States, Critical Care standards, Intensive Care Units standards, Quality Assurance, Health Care organization & administration
- Abstract
The following six points offer a summary of principles to the manager who must develop a QA program: Institutional commitment to the QA process is essential for success. This must be embodied in the table of organization for QA and the commitment of resources to the task. The QA plan should address mechanisms for data collection, data review, and outcome reporting. Lines of responsibility should be stated clearly. The manner in which the outcomes of the QA process are implemented and communicated back to the front-line workers must be clearly stated and continually fed back to them. Clinical evaluations work best in the presence of politically neutral practice guidelines. Vociferous complainers frequently can be made part of the process, harnessing their energy to good effect. Self survey should precede an accreditation site visit by at least 6 months. The best sources of JCAHO thinking on QA methods are the many JCAHO publications, several of which focus on the critical care arena.
- Published
- 1993
17. Continuous intravenous cimetidine decreases stress-related upper gastrointestinal hemorrhage without promoting pneumonia.
- Author
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Martin LF, Booth FV, Karlstadt RG, Silverstein JH, Jacobs DM, Hampsey J, Bowman SC, D'Ambrosio CA, and Rockhold FW
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- Adolescent, Adult, Aged, Aged, 80 and over, Cimetidine administration & dosage, Cimetidine pharmacology, Critical Care, Double-Blind Method, Female, Gastric Acidity Determination, Gastric Juice drug effects, Humans, Infusions, Intravenous, Intensive Care Units, Male, Middle Aged, Peptic Ulcer Hemorrhage etiology, Risk Factors, Severity of Illness Index, Cimetidine therapeutic use, Cross Infection etiology, Peptic Ulcer prevention & control, Peptic Ulcer Hemorrhage prevention & control, Pneumonia etiology, Stress, Physiological complications
- Abstract
Objectives: To determine whether a continuous i.v. infusion of cimetidine, a histamine-2 (H2) receptor antagonist, is needed to prevent upper gastrointestinal (GI) hemorrhage when compared with placebo and if that usage is associated with an increased risk of nosocomial pneumonia. Due to the importance of this latter issue, data were collected to examine the occurrence rate of nosocomial pneumonia under the conditions of this study., Design: A multicenter, double-blind, placebo-controlled study., Interventions: Patients were randomized to receive cimetidine (n = 65) as an iv infusion of 50 to 100 mg/hr or placebo (n = 66)., Setting: Intensive care units in 20 institutions., Patients: Critically ill patients (n = 131), all of whom had at least one acute stress condition that previously had been associated with the development of upper GI hemorrhage., Measurements and Main Results: Samples of gastric fluid from nasogastric aspirates were collected every 2 hrs for measurement of pH and were examined for the presence of blood. Upper GI hemorrhage was defined as bright red blood or persistent (continuing for > 8 hrs) "coffee ground material" in the nasogastric aspirate. Baseline chest radiographs were performed and sputum specimens were collected from all patients, and those patients without clear signs of pneumonia (positive chest radiograph, positive cough, fever) at baseline were followed prospectively for the development of pneumonia while receiving the study medication. Cimetidine-infused patients experienced significantly (p = .009) less upper GI hemorrhage than placebo-infused patients: nine (14%) of 65 cimetidine vs. 22 (33%) of 66 placebo patients. Cimetidine patients demonstrated significantly (p = .0001) higher mean intragastric pH (5.7 vs. 3.9), and had intragastric pH values at > 4.0 for a significantly (p = .0001) higher mean percentage of time (82% vs. 41%) than placebo patients. Differences in pH variables were not found between patients who had upper GI hemorrhage and those patients who did not, although there was no patient in the cimetidine group who bled with a pH < 3.5 compared with 11 such patients in the placebo group. Also, the upper GI hemorrhage rate in patients with one risk factor (23%) was similar to that rate in patients with two or more risk factors (25%). Of the 56 cimetidine-infused patients and 61 placebo-infused patients who did not have pneumonia at baseline, no cimetidine-infused patient developed pneumonia while four (7%) placebo-infused patients developed pneumonia., Conclusions: The continuous i.v. infusion of cimetidine was highly effective in controlling intragastric pH and in preventing stress-related upper GI hemorrhage in critically ill patients without increasing their risk of developing nosocomial pneumonia. While the number of risk factors and intragastric pH may have pathogenic importance in the development of upper GI hemorrhage, neither the risk factors nor the intragastric pH was predictive. Therefore, short-term administration of continuously infused cimetidine offers benefits in patients who have sustained major surgery, trauma, burns, hypotension, sepsis, or single organ failure.
- Published
- 1993
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18. Staff communications and credentialing in a multisite institution.
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Booth FV and Hassett JM
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- Clinical Competence, Critical Care, Education, Medical, Graduate, Educational Measurement, Humans, Pilot Projects, Credentialing, Database Management Systems, General Surgery education, Internship and Residency organization & administration, Local Area Networks, Medical Staff, Hospital education, Medical Staff, Hospital standards, Multi-Institutional Systems organization & administration
- Published
- 1992
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19. Early enteral feeding, compared with parenteral, reduces postoperative septic complications. The results of a meta-analysis.
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Moore FA, Feliciano DV, Andrassy RJ, McArdle AH, Booth FV, Morgenstein-Wagner TB, Kellum JM Jr, Welling RE, and Moore EE
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- Adult, Bacterial Infections epidemiology, Female, Food, Formulated, Humans, Incidence, Male, Meta-Analysis as Topic, Postoperative Care, Postoperative Complications epidemiology, Risk Factors, Time Factors, Bacterial Infections prevention & control, Enteral Nutrition, Parenteral Nutrition, Total, Postoperative Complications prevention & control
- Abstract
This two-part meta-analysis combined data from eight prospective randomized trials designed to compare the nutritional efficacy of early enteral (TEN) and parenteral (TPN) nutrition in high-risk surgical patients. The combined data gave sufficient patient numbers (TEN, n = 118; TPN, n = 112) to adequately address whether route of substrate delivery affected septic complication incidence. Phase I (dropouts excluded) meta-analysis confirmed data homogeneity across study sites, that TEN and TPN groups were comparable, and that significantly fewer TEN patients experienced septic complications (TEN, 18%; TPN, 35%; p = 0.01). Phase II meta-analysis, an intent-to-treat analysis (dropouts included), confirmed that fewer TEN patients developed septic complications. Further breakdown by patient type showed that all trauma and blunt trauma subgroups had the most significant reduction in septic complications when fed enterally. In conclusion, this meta-analysis attests to the feasibility of early postoperative TEN in high-risk surgical patients and that these patients have reduced septic morbidity rates compared with those administered TPN.
- Published
- 1992
- Full Text
- View/download PDF
20. Stress ulcers and organ failure in intubated patients in surgical intensive care units.
- Author
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Martin LF, Booth FV, Reines HD, Deysach LG, Kochman RL, Erhardt LJ, and Geis GS
- Subjects
- Cause of Death, Cimetidine therapeutic use, Double-Blind Method, Female, Follow-Up Studies, Gastroscopy, Humans, Male, Middle Aged, Misoprostol therapeutic use, Multiple Organ Failure prevention & control, Placebos, Pneumonia etiology, Postoperative Complications, Prospective Studies, Respiratory Distress Syndrome complications, Survival Rate, Treatment Outcome, Wound Healing, Critical Care, Multiple Organ Failure complications, Peptic Ulcer prevention & control, Peptic Ulcer Hemorrhage prevention & control, Stress, Physiological complications, Surgical Procedures, Operative adverse effects
- Abstract
This study compared prophylactic administration of either intragastric misoprostol (200 micrograms four times a day), a prostaglandin E1 analog, or bolus intravenous cimetidine (300 mg every 6 hours) in preventing stress lesions and stress bleeding in 127 adult postoperative patients who required mechanical ventilation and also had developed hypotension or sepsis. Both drug treatments were equally effective in preventing the development of diffuse gastritis (greater than 10 gastric hemorrhagic lesions) and in preventing upper gastrointestinal hemorrhage (UGIH). The combined data from both groups showed that for the 44 (35%) patients who died, death was significantly associated with the presence at study entry of renal failure (64% of 25 patients with renal failure died), hepatic failure (57% of 23 patients) or coagulopathy (62% of 29 patients) (p less than 0.02 for each), and with the number of organ system failures at study entry (48% of 69 patients with multiple organ system failures died, p less than 0.001). Death was also significantly associated with the presence of adult respiratory distress syndrome (ARDS) at study entry or the development of ARDS (63% of 24 patients with ARDS died, p less than 0.001), and the development of UGIH (5% of 93 patients with known bleeding outcome died, p less than 0.05). The number of stress lesions that developed was significantly associated with subsequent UGIH (p less than 0.001). Additional organ system failure developed during the study in 31% of the 127 patients, as did diffuse gastritis in 20% of 111 patients who had a follow-up endoscopy. These results demonstrate that postoperative patients who require mechanical ventilation and have hypotension or sepsis are at significant risk for the development of stress gastric lesions and multiple organ system failure even when prophylaxis for stress ulcers is provided. Furthermore, the presence of ARDS, renal failure, hepatic failure, coagulopathy, and UGIH are significantly associated with death.
- Published
- 1992
- Full Text
- View/download PDF
21. Monitoring in resuscitation.
- Author
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Booth FV
- Subjects
- Clinical Protocols standards, Data Collection, Decision Trees, Fluid Therapy standards, Hemodynamics, Humans, Monitoring, Physiologic standards, Resuscitation standards, Time Factors, Fluid Therapy methods, Monitoring, Physiologic methods, Resuscitation methods
- Abstract
It is as important to monitor the passage of time in the resuscitation effort as it is to follow the physiologic parameters. The goals in resuscitation are based on restoring cellular metabolism to a level consistent with optimum survival. The level of invasiveness of monitoring is dictated by the extent to which the patient fails to respond to initial therapy or is judged to be intolerant of even short periods of decompensation. The conduct of a resuscitation must constantly be reassessed in the light of the patient's response to the previous intervention. This response can only adequately be gauged by continual physiologic data gathering with calculation of all relevant derived data and their display in a logical, orderly, and digestible fashion--preferably with the help of a computer.
- Published
- 1992
22. Liver lacerations--a marker of severe but sometimes subtle intra-abdominal injuries in adults.
- Author
-
Harris LM, Booth FV, and Hassett JM Jr
- Subjects
- Abdominal Injuries classification, Abdominal Injuries complications, Abdominal Injuries therapy, Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Shock, Traumatic complications, Wounds, Nonpenetrating diagnosis, Abdominal Injuries diagnosis, Liver injuries
- Abstract
Experience with conservative management of solid viscus injuries from abdominal trauma in children has produced the impetus for a similar management in adults. To explore the implications of such a policy, we reviewed the records of 82 patients with hepatic injuries noted at laparotomy. Indications for laparotomy were positive findings on diagnostic peritoneal lavage (DPL) or CT scan, or a history of penetrating trauma. The liver injuries were graded according to severity: grade I, 19 patients; grade II, 20 patients (low severity = LS); grade III, 14 patients; grade IV, 6 patients (high severity = HS). Twenty-three injuries were not classified by the operating surgeon. Of the 53 patients with blunt hepatic trauma, 23 (43%) had concomitant injuries that required operative intervention. Twenty-nine patients had penetrating liver injuries. Fourteen (48%) had associated injuries requiring intervention. Patients most likely to have nonoperative management, those with grade I and grade II liver injuries (LS), comprised 48 of the total. In this subgroup there were 26 (54.2%) associated injuries requiring operative intervention. Shock could not be used as a factor to differentiate patients not requiring operative intervention. Nineteen of the LS patients requiring operative intervention secondary to associated injury were never in shock. In adult trauma victims positive DPL findings secondary to minor hepatic injuries that might not require operative intervention serve as a marker for associated injuries that do require operation. The risk of nonoperative management of hepatic injuries based upon radiologic diagnosis is not the result of complications from the hepatic injury.(ABSTRACT TRUNCATED AT 250 WORDS)
- Published
- 1991
- Full Text
- View/download PDF
23. Surgical management of complications of endoscopic sphincterotomy with precut papillotomy.
- Author
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Booth FV, Doerr RJ, Khalafi RS, Luchette FA, and Flint LM Jr
- Subjects
- Aged, Duodenum injuries, Female, Hemorrhage etiology, Hemorrhage therapy, Humans, Intestinal Perforation etiology, Intestinal Perforation surgery, Male, Middle Aged, Pancreatitis etiology, Pancreatitis therapy, Ampulla of Vater surgery, Intraoperative Complications, Postoperative Complications, Sphincterotomy, Transduodenal adverse effects
- Abstract
We reviewed 574 endoscopic sphincterotomy procedures. Fifty-six precut papillotomies were performed. Presenting conditions included choledocholithiasis, cholangitis, benign and malignant papillary strictures, and stenosing papillitis. Complications were identified in 16 percent: perforation in 9 percent, pancreatitis in 5 percent, bleeding in 2 percent, and pancreatic abscess in 2 percent. One patient died. Six patients required operation for complications. Perforation of the duodenum or common bile duct seen within 8 hours was managed with drainage and closure of the perforation with minimal complications. Duodenal perforations operated on later than 8 hours required more extensive procedures. All these patients had significant post-operative complications. Three patients were managed nonoperatively. Precut papillotomy carries a significantly higher complication rate than conventional sphincterotomy. Our experience suggests that there is no place for conservative management of duodenal perforation.
- Published
- 1990
- Full Text
- View/download PDF
24. The physcial properties of human pulmonary arteries and veins.
- Author
-
Banks J, Booth FV, MacKay EH, Rajagopalan B, and Lee GD
- Subjects
- Adolescent, Adult, Aged, Aging, Child, Elasticity, Humans, In Vitro Techniques, Middle Aged, Stress, Mechanical, Tensile Strength, Pulmonary Artery physiology, Pulmonary Veins physiology
- Abstract
1. We have studied the extensibility of circumferential strips of main pulmonary artery and large pulmonary veins obtained at post mortem from patients of all ages, dying from conditions other than heart and lung disease. 2. The vessel strips were submitted to increasing loads in a tension balance. The pulmonary arteries were found to be readily extensible. This extensibility became less with increasing age. The pulmonary veins were virtually inextensible at all ages. 3. It is postulated that the large extraparenchymal pulmonary veins have a capacitative role in supplying blood from the lungs to the left atrium. This may be accomplished by their collapsible nature, as they have little capability of distension.
- Published
- 1978
- Full Text
- View/download PDF
25. Combined antegrade/retrograde cardioplegia for myocardial protection: a clinical trial.
- Author
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Bhayana JN, Kalmbach T, Booth FV, Mentzer RM Jr, and Schimert G
- Subjects
- Aged, Cardiopulmonary Bypass, Clinical Trials as Topic, Coronary Artery Bypass, Drug Administration Schedule, Evaluation Studies as Topic, Female, Hemodynamics drug effects, Humans, Injections, Intra-Arterial, Male, Middle Aged, Oxygen Consumption, Stroke Volume drug effects, Time Factors, Cardioplegic Solutions administration & dosage, Heart Arrest, Induced methods, Myocardium metabolism, Perfusion methods
- Abstract
The role of retrograde coronary sinus perfusion in the preservation of ischemic myocardium is controversial. We evaluated the use of combined antegrade and retrograde cardioplegia in 59 patients undergoing coronary artery bypass surgery. Nineteen patients were administered antegrade cardioplegia, whereas 40 patients were administered antegrade plus retrograde cardioplegia. Hemodynamic data were obtained before the onset of cardiopulmonary bypass and at 1, 2, 4, 8, 16, and 24 hours after cessation of cardiopulmonary bypass. Myocardial function was assessed by measuring systemic blood pressure, heart rate, cardiac index, pulmonary artery pressure, and capillary wedge pressure. Both cohorts were similar in age, incidence of hypertension, diabetes, and previous myocardial infarction. No significant differences were noted in the need for postoperative inotropic support, the incidence of postoperative arrhythmias, myocardial infarction, heart block, or death. The two groups were similar with respect to cardiac index and systemic and pulmonary vascular resistance. However, the left ventricular stroke work index, when expressed as a function of its prebypass control value, was significantly improved (p less than 0.01) in the cohort administered combined cardioplegia. In the combined group recovery of left ventricular stroke work index occurred earlier and was more complete. These results suggest that the use of combined antegrade/retrograde cardioplegia is safe and may provide superior protection.
- Published
- 1989
26. Lower esophageal transection with the EEA stapler: an alternative method to control variceal bleeding.
- Author
-
Booth FV, Criado FJ, and Wilson TH Jr
- Subjects
- Humans, Methods, Esophageal and Gastric Varices surgery, Esophagus surgery, Gastrointestinal Hemorrhage surgery, Hemostasis, Surgical methods, Surgical Staplers
- Published
- 1980
27. Impairment of antibacterial defense mechanisms of the lung by extrapulmonary infection.
- Author
-
White JC, Nelson S, Winkelstein JA, Booth FV, and Jakab GJ
- Subjects
- Animals, Caseins pharmacology, Complement C3 analysis, Complement C5 analysis, Escherichia coli Infections complications, Female, Glycogen pharmacology, Lung microbiology, Lung Diseases complications, Macrophages, Peritoneal immunology, Mice, Neutrophils immunology, Peritoneal Cavity microbiology, Peritonitis complications, Pseudomonas Infections complications, Staphylococcal Infections complications, Escherichia coli Infections immunology, Lung immunology, Lung Diseases immunology, Peritonitis immunology, Pseudomonas Infections immunology, Staphylococcal Infections immunology
- Abstract
To determine whether extrapulmonary infection alters antibacterial defenses of the lung, we challenged mice with peritonitis due to Escherichia coli by aerosol inhalation with either Staphylococus aureus or Pseudomonas aeruginosa. In animals without peritonitis, 14% +/- 5% and 11% +/- 1% of the initially deposited viable S. aureus and P. aeruginosa, respectively, remained in the lungs at 4 hr. In contrast, in mice with peritonitis, at 4 hr 45% +/- 9% of the staphylococci were recoved, and the P. aeruginosa had increased to 948% +/- 354% of the initial inoculum. Proliferation of P. aeruginosa in mice with peritonitis was associated with impaired recruitment of polymorphonuclear neutrophils (PMNs) into the lungs. In contrast, a noninfectious stimulus induced more PMNs into the peritoneal cavity than did intraabdominal sepsis but only minimally impaired PMN recruitment into the lungs after aerosol challenge with P. aeruginosa. Sterile intraperitoneal stimulation did not significantly impair intrapulmonary killing of P. aeruginosa. Levels of antigenic C3 and functionally active C5 were significantly depleted in mice with peritonitis due to E. coli. We conclude that the systemic effects of sepsis, including complement depletion, contribute to the decreased pulmonary PMN recruitment and to impaired intrapulmonary bacterial killing of animals with peritonitis due to E. coli.
- Published
- 1986
- Full Text
- View/download PDF
28. Effective staff communications in a large I.C.U.
- Author
-
Booth FV
- Subjects
- Hospital Bed Capacity, 500 and over, Microcomputers, New York, Quality Assurance, Health Care, Computer Systems, Hospital Communication Systems, Intensive Care Units organization & administration, Local Area Networks, Office Automation
- Abstract
A byproduct of the Quality Assurance process is the continual review of individual and group practice. The aim is to eliminate errors and to improve care. For managers and directors to know what issues are currently important to the staff members an upward channel of communication is also needed. In our SICU with over 120 staff there was no documentation of communication in either direction. Casual survey did not reveal a major problem - but the need to document the dissemination of information, particularly new policies - especially to satisfy accrediting agencies - led us to develop MEMOS, an electronic mail system for staff members within the local area network (LAN) in the SICU. The system will run on an individual PC. The network is used because of the physical configuration of the intensive care units. The system is used by nurse managers to keep staff members up to date. Features include: Easy file maintenance. Individual password access. A defined group of system operators with access to all system functions Limited access to all other users. As many as 40 definable sub-groups for the purposes of mail distribution. Easy operator tallying of those delinquent in reading their mail. Hard copy with distribution list for all memos added to system. Browse feature to allow re-reading of old memos. Feedback channel regularly read by system operators. This system has improved the level of staff awareness in the SICU and helped build morale.
- Published
- 1989
- Full Text
- View/download PDF
29. Transient increases in intracranial pressure and the blood-brain barrier.
- Author
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Heck AF, Reichl WW, Hall VR, and Booth FV
- Subjects
- Animals, Cattle, Blood-Brain Barrier, Intracranial Pressure
- Published
- 1973
- Full Text
- View/download PDF
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