Lehigh Valley Hospital

BACKGROUND: Alternative therapies for Staphylococcus aureus bacteremia and endocarditis are needed. METHODS: We randomly assigned 124 patients with S. aureus bacteremia with or without endocarditis to receive 6 mg of daptomycin intravenously per kilogram of body weight daily and 122 to receive initial low-dose gentamicin plus either an antistaphylococcal penicillin or vancomycin. The primary efficacy end point was treatment success 42 days after the end of therapy. RESULTS: Forty-two days after the end of therapy in the modified intention-to-treat analysis, a successful outcome was documented for 53 of 120 patients who received daptomycin as compared with 48 of 115 patients who received standard therapy (44.2 percent vs. 41.7 percent; absolute difference, 2.4 percent; 95 percent confidence interval, -10.2 to 15.1 percent). Our results met prespecified criteria for the noninferiority of daptomycin. The success rates were similar in subgroups of patients with complicated bacteremia, right-sided endocarditis, and methicillin-resistant S. aureus. Daptomycin therapy was associated with a higher rate of microbiologic failure than was standard therapy (19 vs. 11 patients, P=0.17). In 6 of the 19 patients with microbiologic failure in the daptomycin group, isolates with reduced susceptibility to daptomycin emerged; similarly, a reduced susceptibility to vancomycin was noted in isolates from patients treated with vancomycin. As compared with daptomycin therapy, standard therapy was associated with a nonsignificantly higher rate of adverse events that led to treatment failure due to the discontinuation of therapy (17 vs. 8, P=0.06). Clinically significant renal dysfunction occurred in 11.0 percent of patients who received daptomycin and in 26.3 percent of patients who received standard therapy (P=0.004). CONCLUSIONS: Daptomycin (6 mg per kilogram daily) is not inferior to standard therapy for S. aureus bacteremia and right-sided endocarditis. (ClinicalTrials.gov number, NCT00093067 [ClinicalTrials.gov].).

The patient-centered medical home (PCMH) is emerging as a potential catalyst for multiple health care reform efforts. Demonstration projects are beginning in nearly every state, with a broad base of support from employers, insurers, state and federal agencies, and professional organizations. A sense of urgency to show the feasibility of the PCMH, along with a 3-tiered recognition process of the National Committee on Quality Assurance, are influencing the design and implementation of many demonstrations. In June 2006, the American Academy of Family Physicians launched the first National Demonstration Project (NDP) to test a model of the PCMH in a diverse national sample of 36 family practices. The authors make up an independent evaluation team for the NDP that used a multimethod evaluation strategy, including direct observation, in-depth interviews, chart audit, and patient and practice surveys. Early lessons from the real-time qualitative analysis of the NDP raise some serious concerns about the current direction of many of the proposed PCMH demonstration projects and point to some positive opportunities. We describe 6 early lessons from the NDP that address these concerns and then offer 4 recommendations for those assisting the transformation of primary care practices and 4 recommendations for individual practices attempting transformation.

BACKGROUND: The National Cardiogenic Shock Initiative is a single-arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI). METHODS: Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the "SHOCK" trial with an additional exclusion criteria of intra-aortic balloon pump counter-pulsation prior to MCS. RESULTS: A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in-hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST-elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min. Survival to discharge was 72%. Creatinine ≥2, lactate >4, cardiac power output (CPO) <0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12-24 hr reliably predicted overall mortality postindex procedure. CONCLUSION: In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes.

OBJECTIVE: To review the success rate of embolization in stopping hemorrhage for unstable patients with severe pelvic fractures, to calculate the time to achieve embolization, and to determine the yield from angiography. DESIGN: Retrospective review of patients admitted to a Level I trauma center with pelvic fractures during a 5-year period. MATERIALS AND METHODS: Charts were reviewed for Injury Severity Score, age, blood pressure, prothrombin time/partial thromboplastin time, pelvic fracture type, mortality, time to reach the angiography suite, time to achieve embolization, and mechanism of injury. MEASUREMENTS AND MAIN RESULTS: Of 806 patients admitted with pelvic fractures, 35 underwent pelvic angiography, and 15 (1.9%) required embolization. Embolization was successful for all patients. No deaths resulted from ongoing hemorrhage. Angiography yield in initially unstable patients was 64%. The mean age and initial hemodynamic instability were significantly greater in nonsurvivors. The time from arrival in the trauma bay to arrival in the angiography suite ranged from 50 to 1,140 minutes, and the time spent in the angiography suite performing embolization ranged from 50 to 140 minutes, with an average time of 90 minutes. Patients who were embolized within 3 hours of arrival had a significantly greater survival rate. CONCLUSION: Only a small percentage of patients with pelvic fractures require embolization, but when it is used, embolization can be 100% effective. Age, time to achieve embolization, and initial hemodynamic instability appear to be important factors in survival.

BACKGROUND: Focused assessment with sonography for trauma (FAST) as a screening tool in the evaluation of blunt abdominal trauma will lead to underdiagnosis of abdominal injuries and may have an impact on treatment and outcome in trauma patients. METHODS: From October 2001 to June 2002, a protocol for evaluating hemodynamically stable trauma patients with suspected blunt abdominal injury (BAI) admitted to our institution was implemented using FAST examination as a screening tool for BAI and computed tomographic (CT) scanning of the abdomen and pelvis as a confirmatory test. At the completion of the secondary survey, patients underwent a four-view FAST examination (Sonosite, Bothell, WA) followed within 1 hour by an abdominal/pelvic CT scan. The FAST examination was considered positive if it demonstrated evidence of free intra-abdominal fluid. Clinical, laboratory, and imaging results were recorded at admission, and FAST examination results were compared with CT scan findings, noting the discordance. RESULTS: Patients with suspicion for BAI were evaluated according to protocol (n = 372). Thirteen cases were excluded for inadequate FAST examinations, leaving 359 patients for analysis. There were 313 true-negative FAST examinations, 16 true-positives, 22 false-negatives, and 8 false-positives. Using CT scanning as the confirmatory test for hemoperitoneum, FAST examination had a sensitivity of 42%, a specificity of 98%, a positive predictive value of 67%, a negative predictive value of 93%, and an accuracy of 92%; chi analysis showed significant discordance between FAST examination and CT scan (5.85%, < 0.001). Six patients with false-negative FAST examinations required laparotomy for intra-abdominal injuries; 16 patients required admission for nonoperative management of injury. Of the 313 true-negative FAST examinations, 19 patients were noted to have intra-abdominal injuries without hemoperitoneum and 11 patients were noted to have retroperitoneal injuries. CONCLUSION: Use of FAST examination as a screening tool for BAI in the hemodynamically stable trauma patient results in underdiagnosis of intra-abdominal injury. This may have an impact on treatment and outcome in trauma patients. Hemodynamically stable patients with suspected BAI should undergo routine CT scanning.

AIMS: Myocarditis is a potentially fatal complication of immune checkpoint inhibitors (ICI). Sparse data exist on the use of cardiovascular magnetic resonance (CMR) in ICI-associated myocarditis. In this study, the CMR characteristics and the association between CMR features and cardiovascular events among patients with ICI-associated myocarditis are presented. METHODS AND RESULTS: From an international registry of patients with ICI-associated myocarditis, clinical, CMR, and histopathological findings were collected. Major adverse cardiovascular events (MACE) were a composite of cardiovascular death, cardiogenic shock, cardiac arrest, and complete heart block. In 103 patients diagnosed with ICI-associated myocarditis who had a CMR, the mean left ventricular ejection fraction (LVEF) was 50%, and 61% of patients had an LVEF ≥50%. Late gadolinium enhancement (LGE) was present in 48% overall, 55% of the reduced EF, and 43% of the preserved EF cohort. Elevated T2-weighted short tau inversion recovery (STIR) was present in 28% overall, 30% of the reduced EF, and 26% of the preserved EF cohort. The presence of LGE increased from 21.6%, when CMR was performed within 4 days of admission to 72.0% when CMR was performed on Day 4 of admission or later. Fifty-six patients had cardiac pathology. Late gadolinium enhancement was present in 35% of patients with pathological fibrosis and elevated T2-weighted STIR signal was present in 26% with a lymphocytic infiltration. Forty-one patients (40%) had MACE over a follow-up time of 5 months. The presence of LGE, LGE pattern, or elevated T2-weighted STIR were not associated with MACE. CONCLUSION: These data suggest caution in reliance on LGE or a qualitative T2-STIR-only approach for the exclusion of ICI-associated myocarditis.

A total of 1355 patients underwent internal sphincterotomy for chronic fissure in ano between 1980 and 1985. Surgical data were obtained for 1102 patients, and 829 patients responded to a questionnaire. Of the 1057 for whom the time of healing was recorded, 1033 (97.7 per cent) healed by a mean time of 5.6 weeks. No significant differences in satisfaction with the outcome or in deficits in continence were noted between groups undergoing lateral, bilateral or posterior midline sphincterotomy. Excision of the fissure was found to be unnecessary. According to responses on the questionnaires, deficits in continence ranging from 'sometimes' to 'frequently' included lack of control of flatus (35.1 per cent), soiling of underclothing (22.0 per cent) and accidental bowel movements (5.3 per cent). A significantly higher proportion of patients who had accidental bowel movements were aged over 40 years.

OBJECTIVE: To describe models used in successful clinical initiatives to improve the quality of palliative care in critical care settings. DATA SOURCES: We searched the MEDLINE database from inception to April 2010 for all English language articles using the terms "intensive care," "critical care," or "ICU" and "palliative care"; we also hand-searched reference lists and author files. Based on review and synthesis of these data and the experiences of our interdisciplinary expert Advisory Board, we prepared this consensus report. DATA EXTRACTION AND SYNTHESIS: We critically reviewed the existing data with a focus on models that have been used to structure clinical initiatives to enhance palliative care for critically ill patients in intensive care units and their families. CONCLUSIONS: There are two main models for intensive care unit-palliative care integration: 1) the "consultative model," which focuses on increasing the involvement and effectiveness of palliative care consultants in the care of intensive care unit patients and their families, particularly those patients identified as at highest risk for poor outcomes; and 2) the "integrative model," which seeks to embed palliative care principles and interventions into daily practice by the intensive care unit team for all patients and families facing critical illness. These models are not mutually exclusive but rather represent the ends of a spectrum of approaches. Choosing an overall approach from among these models should be one of the earliest steps in planning an intensive care unit-palliative care initiative. This process entails a careful and realistic assessment of available resources, attitudes of key stakeholders, structural aspects of intensive care unit care, and patterns of local practice in the intensive care unit and hospital. A well-structured intensive care unit-palliative care initiative can provide important benefits for patients, families, and providers.

BACKGROUND: The content and context of family practice outpatient visits have never been fully described, leaving many aspects of family practice in a "black box," unseen by policymakers and understood only in isolation. This article describes community family practices, physicians, patients, and outpatient visits. METHODS: Practicing family physicians in northeast Ohio were invited to participate in a multimethod study of the content of primary care practice. Research nurses directly observed consecutive patient visits, and collected additional data using medical record reviews, patient and physician questionnaires, billing data, practice environment checklists, and ethnographic fieldnotes. RESULTS: Visits by 4454 patients seeing 138 physicians in 84 practices were observed. Outpatient visits to family physicians encompassed a wide variety of patients, problems, and levels of complexity. The average patient paid 4.3 visits to the practice within the past year. The mean visit duration was 10 minutes. Fifty-eight percent of visits were for acute illness, 24% for chronic illness, and 12% for well care. The most common uses of time were history-taking, planning treatment, physical examination, health education, feedback, family information, chatting, structuring the interaction, and patient questions. CONCLUSIONS: Family practice and patient visits are complex, with competing demands and opportunities to address a wide range of problems of individuals and families over time and at various stages of health and illness. Multimethod research in practice settings can identify ways to enhance the competing opportunities of family practice to improve the health of their patients.

Hyperlipidemia is a well-established risk factor for developing cardiovascular disease (CVD). The recent American College of Cardiology and American Heart Association guidelines on lipid management emphasize treatment of individuals at increased risk for developing CVD events with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) at doses proven to reduce CVD events. However, there are limited options for patients who are either intolerant to statin therapy, develop CVD despite being on maximally tolerated statin therapy, or have severe hypercholesterolemia. Recently the Food and Drug Administration approved two novel medications for low-density lipoprotein (LDL)-cholesterol reduction: Evolocumab and Alirocumab. These agents target and inactivate proprotein convertase subtilsin-kexin type 9 (PCSK9), a hepatic protease that attaches and internalizes LDL receptors into lysosomes hence promoting their destruction. By preventing LDL receptor destruction, LDL-C levels can be lowered 50%-60% above that achieved by statin therapy alone. This review explores PCSK-9 biology and the mechanisms available to alter it; clinical trials targeting PCSK9 activity, and the current state of clinically available inhibitors of PCSK9.

CONTEXT: As the availability of and demand for genetic testing for hereditary cancers increases in primary care and other clinical settings, alternative or adjunct educational methods to traditional genetic counseling will be needed. OBJECTIVE: To compare the effectiveness of a computer-based decision aid with standard genetic counseling for educating women about BRCA1 and BRCA2 genetic testing. DESIGN: Randomized controlled trial conducted from May 2000 to September 2002. SETTING AND PARTICIPANTS: Outpatient clinics offering cancer genetic counseling at 6 US medical centers enrolled 211 women with personal or family histories of breast cancer. INTERVENTIONS: Standard one-on-one genetic counseling (n = 105) or education by a computer program followed by genetic counseling (n = 106). MAIN OUTCOME MEASURES: Participants' knowledge, risk perception, intention to undergo genetic testing, decisional conflict, satisfaction with decision, anxiety, and satisfaction with the intervention. Counselor group measures were administered at baseline and after counseling. Computer group measures were administered at baseline, after computer use, and after counseling. Testing decisions were assessed at 1 and 6 months. Outcomes were analyzed by high vs low risk of carrying a BRCA1 or BRCA2 mutation. RESULTS: Both groups had comparable demographics, prior computer experience, medical literacy, and baseline knowledge of breast cancer and genetic testing, and both counseling and computer use were rated highly. Knowledge scores increased in both groups (P<.001) regardless of risk status, and change in knowledge was greater in the computer group compared with the counselor group (P =.03) among women at low risk of carrying a mutation. Perception of absolute risk of breast cancer decreased significantly after either intervention among all participants. Intention to undergo testing decreased significantly after either intervention among low-risk but not high-risk women. The counselor group had lower mean scores on a decisional conflict scale (P =.04) and, in low-risk women, higher mean scores on a satisfaction-with-decision scale (P =.001). Mean state anxiety scores were reduced by counseling but were within normal ranges for both groups at baseline and after either intervention, regardless of risk status. CONCLUSIONS: An interactive computer program was more effective than standard genetic counseling for increasing knowledge of breast cancer and genetic testing among women at low risk of carrying a BRCA1 or BRCA2 mutation. However, genetic counseling was more effective than the computer at reducing women's anxiety and facilitating more accurate risk perceptions. These results suggest that this computer program has the potential to stand alone as an educational intervention for low-risk women but should be used as a supplement to genetic counseling for those at high risk.

The impact of social and economic determinants of health status and the existence of racial and ethnic health care access disparities have been well-documented. This paper describes a model, the Health Care Access Barriers Model (HCAB), which provides a taxonomy and practical framework for the classification, analysis and reporting of those modifiable health care access barriers that are associated with health care disparities. The model describes three categories of modifiable health care access barriers: financial, structural, and cognitive. The three types of barriers are reciprocally reinforcing and affect health care access individually or in concert. These barriers are associated with screening, late presentation to care, and lack of treatment, which in turn result in poor health outcomes and health disparities. By targeting those barriers that are measurable and modifiable the model facilitates root-cause analysis and intervention design.

This article is the second in a series reporting on research exploring the effects of Mindfulness-based Stress Reduction on nurses and describes the quantitative data. The third article describes qualitative data. Treatment group participants reduced scores on 2 of 3 subscales of the Maslach Burnout Inventory significantly more than wait-list controls; within-group comparisons for both groups pretreatment and posttreatment revealed similar findings. Changes were maintained as long as 3-month posttreatment. Implications of these findings are discussed.

Introduction: myocarditis is a potentially fatal complication of immune checkpoint inhibitors (ICI). While corticosteroids are the cornerstones of the treatment, there are no data to guide the dose and timing.\n\nMethods: from an international registry of patients with ICI myocarditis diagnosed between 2013 and 2019, data on the type, dose (in methylprednisolone equivalent dose) and timing of steroids were extracted. Major cardiovascular events (MACE) were a composite of cardiovascular death, cardiogenic shock, cardiac arrest, and hemodynamically-significant complete heart block.\n\nResults: in total, 143 ICI myocarditis patients (67±13 years old, 29% women) were included. Among them, 125 received corticosteroids (87%), with the initial agent being either methylprednisolone (95, 76%), prednisone (25, 20%), hydrocortisone (2, 1.6%) or dexamethasone (3, 2.4%). The rates of overall MACE (by admission time tertile 1: 45.8%, tertile 2: 43.8%, tertile 3: 38.3%, P=0.746) and individual elements of MACE were unchanged from 2013 to 2019. The initial corticosteroid dose was categorized as low (&amp;lt;60mg), intermediate (≥60mg and ≤500mg) and high (&amp;gt;500mg). There was an inverse relationship between the occurrence of MACE and initial dose of corticosteroid, where MACE declined with increasing doses (low 61.9%, intermediate 54.6%, high 20.4%, P&amp;lt;0.001). The median time from admission to the first corticosteroids was 45 (15.5, 89) hours. Patients receiving corticosteroids within 24 hours had significantly lower MACE (7.0%) compared to those between 24-72 hours (34.3%) and those &amp;gt;72 hours (85.7%, P&amp;lt;0.001). The dose interacted with timing of initiation whereby high dose corticosteroids within 24 hours achieved the best outcome and low corticosteroids after 72 hours had the worst outcome (Fig 1).\n\nConclusions: ICI myocarditis is associated with high rate of MACE. Higher initial dose and earlier initiation of corticosteroids were associated with improved outcomes.

Clinical practice guidelines are being used as a means of reducing inappropriate care, controlling geographic variations in practice patterns, and making more effective use of health care resources. Developments at the national health policy level, as well as managed care imperatives, suggest that clinical practice guidelines will play an increasingly prominent role in the practice of medicine. These guidelines can contribute to medicine as an aid in clinical decision making and improving clinical practice [1,2] and as a research tool and an educational resource. We, as trauma surgeons, should participate in such endeavors in an effort to improve trauma care and guide future research. The Agency for Health Care Policy and Research (AHCPR) has led the way in guideline development methodology and currently has published 20 guidelines addressing a variety of topics. [3] Its initial work has led others to develop an evidence-based approach to care. Evidence-based guidelines have been published on intravenous analgesia, sedation, sustained neuromuscular blockade in the intensive care unit, and management of severe head injury. [4-6] Clinical computerized bedside protocols have improved outcome in adult respiratory distress syndrome and hypoxia. [7,8] National literature/consensus-based guidelines have also been published for stress ulcer prophylaxis and albumin transfusion and are currently in development for antibiotic use and fever workup in the intensive care unit. [9,10] The role of the Eastern Association for the Surgery of Trauma (EAST) and other national organizations will be to provide a series of national consensus-based guidelines from which institutionally specific clinical management protocols or pathways can be developed (see Figure 1).Figure 1: Guideline and protocol development.A step-by-step process of practice management guideline development, largely adapted from AHCPR recommendations, has been derived [11] to ensure a combination of rigorous methodology and practical feasibility that can be adapted to clinical decision making at any institution (Table 1). Key to guideline development is assessment of the scientific evidence and formulation of recommendations (Table 2).Table 1: Steps to practice management guideline developmentTable 2: Classification of scientific evidence and formulation of recommendationsA current limitation on the concept of guideline development is the paucity of prospective, randomized class I data for the development of more secure evidence-based guidelines. It is hoped that through the development of guidelines, a baseline can be created to direct future research and create more class I data. With these thoughts in mind, a consensus conference of 20 trauma surgeons interested in guideline development was held and initial topics were selected for development. Each member of the conference selected topics that he or she felt were important for development. Four topics were then selected by majority consensus. Each topic was assigned a chairperson, and the chairperson was then responsible for selecting his or her committee members. The individual committees were given latitude on how to approach their topics, but all were expected to conform to the process described above. Once completed, the guidelines were reviewed by the committee chairperson and the chairperson of the guideline committee and returned for revision. The revised guidelines were submitted to the EAST program chairman, the president of EAST, and the board members. The guidelines were presented at the annual meeting of EAST in 1997, and revisions were made based on comments and suggestions from the members. What follows is an abridged version of these guidelines. The unabridged version, which contains a more lengthy discussion of the scientific evidence, data classification, and evidentiary tables, as well as a complete bibliography, is available through the EAST web page (www.east.org) or by written request. Send requests to: EAST Guidelines, c/o Judith Schultz, Trauma Program Development Office, Lehigh Valley Hospital, Cedar Crest & I-78, P.O. Box 689, Allentown, PA 18105-1556. Practice Management Guidelines for Screening of Blunt Cardiac Injury Michael D. Pasquale, MD, Division of Trauma/Surgical Critical Care, Lehigh Valley Hospital, Allentown, Pa; Kimberly K. Nagy, MD, Department of Trauma, Cook County Hospital, Chicago, Ill; John R. Clarke, MD, Department of Surgery, Allegheny University Hospital, Philadelphia, Pa. Practice Management Guidelines for Identifying Cervical Spine Injuries after Trauma Donald W. Marion, MD, Chairman, Department of Neurosurgery, Presbyterian University Hospital, Pittsburgh, Pa; Robert Domeier, MD, Department of Emergency Medicine, St. Joseph Mercy Hospital, Ann Arbor, Mich; C. Michael Dunham, MD, St. Elizabeth Hospital Trauma Center, Youngstown, Ohio; Fred A. Luchette, MD, Division of Trauma/Critical Care, University of Cincinnati College of Medicine, Cincinnati, Ohio; Regis Haid, MD, Department of Neurological Surgery, Emory University School of Medicine, Atlanta, Ga; Scott C. Erwood, MD, Emory Clinic, Atlanta, Ga. Practice Management Guidelines for Penetrating Intraperitoneal Colon Injuries C. Gene Cayten, MD, Institute for Trauma and Emergency Care, New York Medical College, Valhalla, NY; Timothy C. Fabian, MD, University of Tennessee College of Medicine, Memphis, Tenn; Victor F. Garcia, MD, Division of Pediatric Surgery, Children's Hospital Medical Center, Cincinnati, Ohio; Rao R. Ivatury, MD, Department of Surgery, New York Medical College/Lincoln Hospital, Bronx, NY; John A. Morris, Jr., MD, Division of Trauma and Surgical Critical Care, Vanderbilt University, Nashville, Tenn. Practice Management Guidelines for Venous Thromboembolism in Trauma Patients - The Use of Low-Dose Heparin (LDH) for Deep Venous Thrombosis/Pulmonary Embolus (DVT/PE) Prophylaxis - The Use of Sequential Compression Devices (SCDs) in the Prevention of DVT/PE - The Role of Low Molecular Weight Heparin in Venous Thromboembolism Prophylaxis in Trauma Patients - The Role of Arteriovenous Foot Pumps in the Prophylaxis of DVT/PE in the Trauma Patient - The Role of the Vena Cava Filter in the Prophylaxis and Treatment of PE - The Role of Treatment of Established DVT/PE with Anticoagulation in the Trauma Patient - The Role of Ultrasonography in Diagnostic Imaging for DVT in Trauma - The Role of Impedance Plethysmography (IPG) in Diagnostic Imaging for DVT in Trauma - The Role of Venography in the Diagnosis of DVT in Trauma Patients Frederick B. Rogers, MD, Department of Surgery, University of Vermont College of Medicine, Burlington, Vt; Mark D. Cipolle, MD, PhD, Division of Trauma/Surgical Critical Care, Lehigh Valley Hospital, Allentown, Pa; James G. Cushman, MD, Division of Trauma/Surgical Critical Care, Lehigh Valley Hospital, Allentown, Pa; Paul A. Kearney, MD, Department of Surgery, University of Kentucky Chandler Medical Center, Lexington, Ky; Grace S. Rozycki, MD, Department of Surgery, Emory University School of Medicine, Atlanta, Ga; William H. Geerts, MD, Sunnybrook Health Science Center/University of Toronto, Toronto, Ontario, Canada. PRACTICE MANAGEMENT GUIDELINES FOR SCREENING OF BLUNT CARDIAC INJURY I. Statement of the Problem The reported incidence of blunt cardiac injury (BCI), formerly called myocardial contusion, depends on the modality and criteria used for diagnosis and ranges from 8 to 71% in patients who sustain blunt chest trauma. The true incidence remains unknown because there is no diagnostic gold standard, i.e., the available data are conflicting with respect to how the diagnosis should be made (electrocardiogram (EKG), enzyme analysis, echocardiogram, etc.) The lack of such a standard leads to confusion with respect to making a diagnosis and makes the literature difficult to interpret. Key issues involve identifying a patient population at risk for adverse events from BCI and then appropriately monitoring and treating these patients. Conversely, patients not at risk could potentially be discharged from the hospital with appropriate follow-up. II. Process from through was with the cardiac and were to the series of patients in cardiac and on were from the that were or the of A. I should be for all patients in there is B. the are the patient should be for monitoring for to Conversely, the are the risk of a BCI that is and the of diagnosis should be the patient is an should be an be then the patient should have a medicine with are not an has been C. patients with cardiac and with an can be on that are appropriately should be given to of a in such The of a not the of BCI not that monitoring should be with of cardiac are in which patients have or will have to the diagnosis of BCI should be in patients with an appropriate of injury or in who an or to their injury. no or combination of has in cardiac injury. The diagnosis of BCI will be to the with which is The appropriate a of the used and the of the on clinical management should on patients who develop to Diagnostic should be with the and currently should be in all future I of blunt cardiac trauma. monitoring of patients with blunt cardiac injury. Ann The of cardiac in the patient with myocardial Victor The role of in blunt chest a and and in cardiac Ann after blunt trauma of the and other clinical of cardiac trauma. Emergency in patients with myocardial cardiac assessment with Diagnosis of cardiac K. of a approach to the diagnosis of cardiac after chest injury. Care in patients with blunt chest trauma as by myocardial intensive care is not for myocardial Care in blunt clinical means of and for patient The of in blunt chest trauma. in patients with myocardial diagnostic or of A. Clinical of blunt chest trauma. for management of myocardial in the of care is of patients blunt chest trauma for evidence of cardiac injury. can the diagnosis be Cardiac the on management of the patient with trauma The patient with myocardial D. Blunt cardiac is diagnosis K. Diagnosis of cardiac Care of myocardial and in patients with blunt trauma. myocardial and for Ann of myocardial of and cardiac with and based on the for cardiac The of in for myocardial of and in patients with blunt chest trauma. The use of in the of chest trauma. The clinical of myocardial Diagnosis of myocardial of myocardial injury blunt chest a of with other D. of myocardial blunt chest trauma. Diagnosis of myocardial Cardiac are in the patient with myocardial cardiac in patients with myocardial of cardiac with cardiac I. MD, S. Pediatric blunt cardiac clinical and Pediatric Emergency Research on Blunt Cardiac F. of blunt cardiac myocardial The of in cardiac cardiac in myocardial PRACTICE MANAGEMENT GUIDELINES FOR I. Statement of the Problem of the of the is a by with the for the care of trauma patients. specific issues are of for and What of the should be should or be how the of injury in the trauma II. Process A. of computerized of the National of was from the 20 with in the and the or were the with the of in the after and these were selected for were to the or were of such as to not in that were of of patients or addressing specific to practice B. of the The to the was developed for have been no such developed for use with that not with and of the is a of diagnosis were to the diagnosis of a population a population at a a of the or of the with the and a specific of the A. I is evidence to a I for practice management B. 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Ann the initial Cervical injury in head trauma. of in of blunt a of and series in the of patients with trauma. Ann of for in trauma patients. in the initial of the Ann with head role of criteria for in blunt a Ann the in the use of PRACTICE MANAGEMENT GUIDELINES FOR I. Statement of the Problem Management of has been the that in the population were managed by of the or because of the of a of the 20 there has been a use of of are the of with the in the of the and the with care and the for of are the and with of there is no in the be there have been that there is confusion is II. Process computerized of the National of was the through the and were from the of the with or series of were The of were from literature and from that were that were of of patients who sustained trauma with injury and in which the of management was of reported on after injury. The were reviewed by a of trauma surgeons who to practice management A. I are class I and class data to a standard of for of of the in the of B. Patients with that are of of the or of a can and - are evidence of or as by - have no - have Trauma Injury - have no Patients with or should have managed by and after and trauma can be is to to patients who not have or are should not be to or for trauma in patients who have no for being at risk for or The with of the with the from to of the and the with and the of the all a standard for of the data and for patients Patients with or have with and should be in a prospective, randomized and on the role of and the of for I Management of and Ann I Management of a randomized Ann or with Colon of a randomized R. of in trauma a randomized in is of a in patients. Ann Colon management and in trauma. D. of the role of Ann of a PRACTICE MANAGEMENT GUIDELINES FOR The Use of Low-Dose Heparin (LDH) for Deep Venous Thrombosis/Pulmonary Embolus (DVT/PE) Prophylaxis I. Statement of the Problem The that DVT and PE after trauma is The of prophylaxis has to be or modality used for prophylaxis DVT and of in more patients that the incidence of DVT from in patients with no prophylaxis to in patients PE was by in patients with in the incidence of was in patients in but was not such as were more in patients in has not been to be effective in in trauma patients. that was not in DVT no prophylaxis in patients with an in these were and a be The of in with to are more are of a modality of and the trauma patient who is at risk for is and has been in the The injury to patients for severe head injury and injury. of trauma surgeons has developed a assessment tool for and evidence as a of the development of EAST The risk are (Table of of to and of assessment tool for in Process from to the to the use of in and patients. the to the use of in trauma patients were used for the A. I has as a for prophylaxis in the trauma patient at risk for B. patients in could their as with severe or with and being managed the of has not been and an individual decision should be made C. be a role for the use of in combination with in trauma patients at risk for there are data in trauma patients to such a The of for prophylaxis of in trauma patients remains no of on on the use of in trauma patients from severe and the of a are data to not in a in trauma patients. should on the of in trauma patients. I Prevention of in of Ann of with as prophylaxis after trauma. Prevention of in trauma patients. The Use of Sequential Compression Devices (SCDs) in the Prevention of DVT/PE I. Statement of the Problem the risk of have been to and on the have been to have a direct on the to the of and the of a of prospective, randomized have been to the incidence of DVT and suggest that should be with practice has not been and is not of have been in and have been with of the which should be II. Process from to the a of on to were of these were to the guidelines. A. I are data to I recommendations on B. Trauma patients at risk for such as patients with head or or should for prophylaxis C. patients in the is for the of at the level, as an effective to the of DVT Patients who have in the or evidence of should have in to the of The use of on the in patients at risk for DVT and to the of DVT is clinical their in trauma patients are the of of is not their is to be based on a combination of addressing and these are and to specific the appropriate use of are to be to the use of in trauma patients at risk for the of the on and an a to be are a of of and is to be the role of and to provide any from to be of for of with to to and after a prospective, randomized of and and and and have an on the of Thromboembolism trauma. Prevention of in trauma patients. H. of of the of for the of in trauma a prospective, randomized of no and of S. The of in the of after cardiac The Role of Low Molecular Weight Heparin in Venous Thromboembolism Prophylaxis in Trauma Patients I. Statement of the Problem The use of has for reducing the risk of the 20 in trauma patients with an was to be more in DVT The more but was not of trauma was to have to in DVT the DVT incidence for all was The literature contains that for prophylaxis and is more in The literature is more but of for for prophylaxis in the of prophylaxis was to patients were II. Process and a of the literature of the use of in class I and class were for A. I are data to I recommendations for use of as prophylaxis in trauma patients. B. should be used for prophylaxis in trauma patients with the injury or as or in or and injury with complete or C. Trauma patients with an who can should as their of The use of or for after injury should be in patients who at risk for injury and patients who and or is a of class I data the use of as prophylaxis in literature is derived from and patients. to be or to for prophylaxis in patients. are class I data that is to for prophylaxis in to trauma patients. data in of patients improved of with the or risk with prophylaxis with should be the standard of prophylaxis in trauma patients with and as well as in with I data that should be for use in all trauma patients their risk is are issues prophylaxis of trauma patients that to be in a are being at of which will the use of in trauma patients and the of and these are completed, the class I data will more the role of for prophylaxis in trauma patients. are that institution guidelines for risk and guidelines the and surgeons for risk after trauma. I use in the of randomized of a to in patients C. Prevention of after by of of 20 B. prophylaxis with in The of a and for the of in patients Prevention of a randomized with in patients Low with in of randomized of in of a of of in patients with a of the of the of in the a with Prevention of after injury Ann B. Prevention of and after of and Prevention of after a randomized with standard Ann and of a in by in a The of a in a Prevention of after a a to A. of patients given prophylaxis with or for after for of with for prophylaxis after or Low standard for of after Prophylaxis for the of after a and G. Prevention of with a Ann Heparin with for of or a and for the of after and of to after Ann Low as prophylaxis in patients. and of for of after or for the of in and and of to for of a is effective and Prophylaxis of in 20 and as prophylaxis after with a in a of with as prophylaxis after trauma. Prevention of after a with Ann for the of a randomized in patients of after hospital in patients of The Role of Arteriovenous Foot Pumps in the Prophylaxis of DVT/PE in the Trauma Patient I. Statement of the Problem and in a on the of the that of a of that by and the has been developed to of The of is that to the which to be used in patients with or who were for has that the of the in the by II. Process With the clinical of the there is a paucity of literature to to on were to the use of in the trauma A. I are data to suggest I recommendations for B. are data to suggest recommendations for C. be used as a for in trauma patients who because of or clinical series in patients the use of to clinical series in trauma patients with other standard of DVT The from series are not in of the of in is a to the use of in trauma patients who have a to because of their and who have on the because of or prospective, randomized are with standard in trauma patients at risk for the development of I S. Prophylaxis in of and Prophylaxis after and with after The and after for prophylaxis in of the The of in of after S. Use of in in trauma patients. The Role of the Vena Cava Filter in the Prophylaxis and Treatment of PE I. Statement of the Problem Vena is a of PE prophylaxis that is being used more in trauma patients with or with or injury who will not of patients with have that the use of The decision to a in a trauma patient a of the The data in that the is in a trauma The the patient and the and of The literature is difficult to because of in their of a is to the data available for the use of for in the trauma i.e., after the patient has clinical or evidence of a DVT or II. Process from to was with of the literature other and that of in trauma patients. there were that and with that are in A. I is a of evidence not reviewed in to of a for standard in trauma patients. These - PE - DVT and to - DVT and on - of B. for in a patient with DVT or PE - in the or the - after PE in which - or after C. of a should be in patients a DVT/PE because of risk and have or more of the injury - severe head injury - injury with or - with - Patients at risk for for to after injury with injury with injury or or risk for ulcer and to or or is no class I literature to of a in a trauma patient an DVT or is to a of class and data that use in trauma patients a of a DVT or of in patients a DVT or PE who criteria and be is an for class I prospective, data to or the use of in trauma patients. to patients with a PE to to and improve outcome in the patients who a The of such a has been completed, and the should involve from trauma important issues the incidence of important PE in patients who and can a of patients be who have a with The and of used as prophylaxis in trauma patients to be the of to be I MD, with the use of the prophylaxis of in patients for in trauma and Surgical prophylaxis for Use of the in patients with trauma. in patients with S. in trauma patients the incidence of and of in patients at risk for The Role of the Treatment of Established DVT/PE with Anticoagulation in the Trauma Patient I. Statement of the Problem a patient with a the of are to of the and evidence to the of DVT with intravenous from a randomized by and in which the of intravenous was with that of in the initial of in of with and in of with intravenous prospective, of for there were no to PE in the with a of in who not could be for

BACKGROUND: Human polymerized hemoglobin (PolyHeme, Northfield Laboratories) is a universally compatible oxygen carrier developed to treat life-threatening anemia. This multicenter phase III trial was the first US study to assess survival of patients resuscitated with a hemoglobin-based oxygen carrier starting at the scene of injury. STUDY DESIGN: Injured patients with a systolic blood pressure</=90 mmHg were randomized to receive field resuscitation with PolyHeme or crystalloid. Study patients continued to receive up to 6 U of PolyHeme during the first 12 hours postinjury before receiving blood. Control patients received blood on arrival in the trauma center. This trial was conducted as a dual superiority/noninferiority primary end point. RESULTS: Seven hundred fourteen patients were enrolled at 29 urban Level I trauma centers (79% men; mean age 37.1 years). Injury mechanism was blunt trauma in 48%, and median transport time was 26 minutes. There was no significant difference between day 30 mortality in the as-randomized (13.4% PolyHeme versus 9.6% control) or per-protocol (11.1% PolyHeme versus 9.3% control) cohorts. Allogeneic blood use was lower in the PolyHeme group (68% versus 50% in the first 12 hours). The incidence of multiple organ failure was similar (7.4% PolyHeme versus 5.5% control). Adverse events (93% versus 88%; p=0.04) and serious adverse events (40% versus 35%; p=0.12), as anticipated, were frequent in the PolyHeme and control groups, respectively. Although myocardial infarction was reported by the investigators more frequently in the PolyHeme group (3% PolyHeme versus 1% control), a blinded committee of experts reviewed records of all enrolled patients and found no discernable difference between groups. CONCLUSIONS: Patients resuscitated with PolyHeme, without stored blood for up to 6 U in 12 hours postinjury, had outcomes comparable with those for the standard of care. Although there were more adverse events in the PolyHeme group, the benefit-to-risk ratio of PolyHeme is favorable when blood is needed but not available.

Patellofemoral problems are a common cause of morbidity and reoperation after total knee arthroplasty. We made a prospective study of 52 patients who had bilateral arthroplasty (104 knees) and in whom the patella was resurfaced on one side and not on the other. A movable-bearing prosthesis with an anatomical femoral groove was implanted on both sides by the same surgeon using an otherwise identical technique. The mean follow-up was 5.24 years (2 to 10). In the 30 available patients (60 knees) there was no difference between the two sides in subjective preference, performance on ascending and descending stairs or the incidence of anterior knee pain. Radiographs showed no differences in prosthetic alignment, femoral condylar height, patellar congruency or joint line position. The use of an appropriate prosthetic design and careful surgical technique can provide equivalent results after knee arthroplasty with or without patellar resurfacing. Given the indications and criteria, which we discuss, retention of the patellar surface is an acceptable option.

BACKGROUND: Clostridium difficile colitis has increased in incidence and severity, and treatment failure with metronidazole therapy has increasingly been documented. It is uncertain whether treatment with vancomycin is more effective than treatment with metronidazole, but concern over the emergence of vancomycin resistance has motivated the search for alternative therapy. Nitazoxanide, a nitrothiazolide, blocks anaerobic metabolism of eukaryocyes and effectively treats intestinal infestation due to Cryptosporidium or Giardia species. At low concentrations, this compound inhibits C. difficile in vitro. METHODS: We designed a prospective, randomized, double-blind study to compare nitazoxanide to metronidazole in treating hospitalized patients with C. difficile colitis. RESULTS: Thirty-four patients received metronidazole at a dosage of 250 mg 4 times per day for 10 days, 40 patients received nitazoxanide at a dosage of 500 mg 2 times per day for 7 days, and 36 patients received nitazoxanide at a dosage of 500 mg 2 times per day for 10 days. After 7 days of treatment, 28 (82.4%) of 34 patients had responded to metronidazole therapy, compared with 68 (89.5%) of 76 who had received nitazoxanide therapy (difference, 7.1%; 95% confidence interval, -7.1% to 25.5%). Thirty-one days after beginning treatment, sustained responses were observed in 19 (57.6%) of 33 patients who had received metronidazole therapy for 10 days, compared with 25 (65.8%) of 38 who had received nitazoxanide for 7 days and 26 (74.3%) of 35 who had received nitazoxanide for 10 days (P = .34). CONCLUSION: Nitazoxanide is at least as effective as metronidazole in treating C. difficile colitis.

Sixty 12-week-old infants participated in a laboratory study to explore the relations between temperament and cardiac vagal tone. Temperament was evaluated via laboratory observations and maternal ratings. Cardiac vagal tone, measured as the amplitude of respiratory sinus arrhythmia, was quantified from beat-to-beat heart period data collected during a resting baseline period and during the laboratory assessment of temperament. Specific hypotheses were investigated relating temperament to both basal cardiac vagal tone and changes in cardiac vagal tone during social/attention challenges. Infants with higher baseline cardiac vagal tone were rated in the laboratory as showing fewer negative behaviors and were less disrupted by the experimental procedure. Infants who decreased cardiac vagal tone during the laboratory assessment were rated on maternal report temperament scales as having longer attention spans, and being more easily soothed.

BACKGROUND: Understanding the organization of primary care practices is essential for implementing changes related to delivery of preventive or other health care services. A theoretical model derived from complexity theory provides a framework for understanding practice change. METHODS: Data were reviewed from brief participant observation fieldnotes collected in the 84 practices of the Direct Observation of Primary Care (DOPC) study and in 27 practices from three similar studies investigating preventive services delivery. These data were synthesized with information from an extensive search of the social science, nursing, and health services literature concerning practice organization, and of the literature on complexity theory from the fields of mathematics, physics, biology, management, medicine, and family systems, to create a complexity model of primary care practice. RESULTS: Primary care practices are understood as complex adaptive systems consisting of agents, such as patients, office staff, and physicians, who enact internal models of income generation, patient care, and organizational operations. These internal models interact dynamically to create each unique practice. The particular shape of each practice is determined by its primary goals. The model suggests three strategies for promoting change in practice and practitioner behavior: joining, transforming, and learning. CONCLUSIONS: This model has important implications for understanding change in primary care practice. Practices are much more complex than present strategies for change assume. The complexity model identified why some strategies work in particular practices and others do not.