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Competing Interests: The authors have declared that no competing interests exist.

Background: Many studies have identified racial disparities in healthcare, but few have described disparities in the use of anesthesia modalities. We examined racial disparities in the use of local versus general anesthesia for inguinal hernia repair. We hypothesized that African American and Hispanic patients would be less likely than Caucasians to receive local anesthesia for inguinal hernia repair., Materials and Methods: We included 78,766 patients aged ≥ 18 years in the Veterans Affairs Surgical Quality Improvement Program database who underwent elective, unilateral, open inguinal hernia repair under general or local anesthesia from 1998-2018. We used multiple logistic regression to compare use of local versus general anesthesia and 30-day postoperative complications by race/ethnicity., Results: In total, 17,892 (23%) patients received local anesthesia. Caucasian patients more frequently received local anesthesia (15,009; 24%), compared to African Americans (2353; 17%) and Hispanics (530; 19%), P < 0.05. After adjusting for covariates, we found that African Americans (OR 0.82, 95% CI 0.77-0.86) and Hispanics (OR 0.77, 95% CI 0.69-0.87) were significantly less likely to have hernia surgery under local anesthesia compared to Caucasians. Additionally, local anesthesia was associated with fewer postoperative complications for African American patients (OR 0.46, 95% CI 0.27-0.77)., Conclusions: Although local anesthesia was associated with enhanced recovery for African American patients, they were less likely to have inguinal hernias repaired under local than Caucasians. Addressing this disparity requires a better understanding of how surgeons, anesthesiologists, and patient-related factors may affect the choice of anesthesia modality for hernia repair., (Copyright © 2021. Published by Elsevier Inc.)

Background: Inguinal hernia repair is the most common general surgery operation in the United States. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15%-20% using local anesthesia, despite the absence of evidence for the superiority of the former. Although patients aged 65 y and older are expected to benefit from avoiding general anesthesia, this presumed benefit has not been adequately studied. We hypothesized that the benefits of local over general anesthesia for inguinal hernia repair would increase with age., Materials and Methods: We analyzed 87,794 patients in the American College of Surgeons National Surgical Quality Improvement Project who had elective inguinal hernia repair under local or general anesthesia from 2014 to 2018, and we used propensity scores to adjust for known confounding. We compared postoperative complications, 30-day readmissions, and operative time for patients aged <55 y, 55-64 y, 65-74 y, and ≥75 y., Results: Using local rather than general anesthesia was associated with a 0.6% reduction in postoperative complications in patients aged 75+ y (95% CI -0.11 to -1.13) but not in younger patients. Local anesthesia was associated with faster operative time (2.5 min - 4.7 min) in patients <75 y but not in patients aged 75+ y. Readmissions did not differ by anesthesia modality in any age group. Projected national cost savings for greater use of local anesthesia ranged from $9 million to $45 million annually., Conclusions: Surgeons should strongly consider using local anesthesia for inguinal hernia repair in older patients and in younger patients because it is associated with significantly reduced complications and substantial cost savings., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The effectiveness of neurosurgical operating room (OR) checklists to improve communication, safety attitudes, and clinical outcomes is uncertain., Purpose: To develop, implement, and evaluate a post-operative neurosurgery operating room checklist., Methods: Four large academic medical centers participated in this study. We developed an evidence-based checklist to be performed at the end of every adult-planned or emergent surgery in which all team members pause to discuss key elements of the case. We used a prospective interrupted time series study design to assess trends in clinical and cost outcomes. Safety attitudes and communication among OR providers were also assessed., Results: There were 11,447 neurosurgical patients in the preintervention and 10,973 in the postintervention periods. After implementation, survey respondents perceived that postoperative checklists were regularly performed, important issues were communicated at the end of each case, and patient safety was consistently reinforced. Observed to expected (O/E) overall mortality rates remained less than one, and 30-day readmission rate, length of stay index, direct cost index, and perioperative venous thromboembolism and hematoma rates remained unchanged as a result of checklist implementation., Conclusion: A neurosurgical checklist can improve OR team communication; however, improvements in safety attitudes, clinical outcomes, and health system costs were not observed.

As part of the American Society of Anesthesiology Brain Health Initiative goal of improving perioperative brain health for older patients, over 30 experts met at the fifth International Perioperative Neurotoxicity Workshop in San Francisco, CA, in May 2016, to discuss best practices for optimizing perioperative brain health in older adults (ie, >65 years of age). The objective of this workshop was to discuss and develop consensus solutions to improve patient management and outcomes and to discuss what older adults should be told (and by whom) about postoperative brain health risks. Thus, the workshop was provider and patient oriented as well as solution focused rather than etiology focused. For those areas in which we determined that there were limited evidence-based recommendations, we identified knowledge gaps and the types of scientific knowledge and investigations needed to direct future best practice. Because concerns about perioperative neurocognitive injury in pediatric patients are already being addressed by the SmartTots initiative, our workshop discussion (and thus this article) focuses specifically on perioperative cognition in older adults. The 2 main perioperative cognitive disorders that have been studied to date are postoperative delirium and cognitive dysfunction. Postoperative delirium is a syndrome of fluctuating changes in attention and level of consciousness that occurs in 20%-40% of patients >60 years of age after major surgery and inpatient hospitalization. Many older surgical patients also develop postoperative cognitive deficits that typically last for weeks to months, thus referred to as postoperative cognitive dysfunction. Because of the heterogeneity of different tools and thresholds used to assess and define these disorders at varying points in time after anesthesia and surgery, a recent article has proposed a new recommended nomenclature for these perioperative neurocognitive disorders. Our discussion about this topic was organized around 4 key issues: preprocedure consent, preoperative cognitive assessment, intraoperative management, and postoperative follow-up. These 4 issues also form the structure of this document. Multiple viewpoints were presented by participants and discussed at this in-person meeting, and the overall group consensus from these discussions was then drafted by a smaller writing group (the 6 primary authors of this article) into this manuscript. Of course, further studies have appeared since the workshop, which the writing group has incorporated where appropriate. All participants from this in-person meeting then had the opportunity to review, edit, and approve this final manuscript; 1 participant did not approve the final manuscript and asked for his/her name to be removed.

Patient navigation, a patient-centered model of care coordination focused on reducing barriers to care, is an emerging strategy for linking patients to and retaining them in HIV care. The Guide to Healing Program (G2H), implemented at the Infectious Diseases Clinic at UNC Chapel Hill, provided patient navigation to women of color (WOC) new to or re-engaging in HIV care through a 'nurse guide' with mental health training and experience. The purpose of this study was to qualitatively explore patients' experiences working with the nurse guide. Twenty-one semi-structured telephone interviews with G2H participants were conducted. Interviews were transcribed and thematic analysis was utilized to identify patterns and themes in the data. Women's experiences with the nurse guide were overwhelmingly positive. They described the nurse guide teaching them critical information and skills, facilitating access to resources, and conveying authentic kindness and concern. The findings suggest that a properly trained nurse in this role can provide critical medical and psychosocial support in order to eliminate barriers to engagement in HIV care, and successfully facilitate patient HIV self-management. The nurse guide model represents a promising approach to patient navigation for WOC living with HIV.

Purpose: This retrospective study evaluated the effectiveness and tolerability in clinical practice of an L-proline-stabilized 10 % intravenous immunoglobulin (IVIG; Privigen®) in patients with primary (PID) or secondary immunodeficiency (SID)., Methods: Patients from 6 centers in Europe and the US were treated with individually determined regimens of Privigen® for ≥3 months. Serum immunoglobulin G (IgG) trough levels, annualized rates of infection, hospitalization and antibiotics use, and the incidence of adverse events (AEs) were analyzed., Results: Of 72 patients, three infants with severe combined immunodeficiency (SCID) were analyzed separately. The remaining 69 patients (52.2 % male; median age 38 years [range: 0.1-90.0]) with PID (82.6 %) or SID (17.4 %) received a mean (±standard deviation) Privigen® dose of 532 ± 250 mg/kg/month resulting in trough serum IgG levels of 407-1,581 mg/dL (median: 954 mg/dL). Ten patients (14.5 %) experienced 11 serious bacterial infections over 22.0 ± 15.0 months of treatment (0.087 events/patient/year, upper one-sided 99 % confidence interval: 0.170), the most common being pneumonia (11.6 %). The rates for any infection and hospitalization were 1.082 events/patient/year and 3.63 days/patient/year, respectively. Two patients with severe disease accounted for 303 of 460 hospital days. Across all 72 patients, 13 (18.1 %) patients experienced AEs, including 10 (13.9 %) patients with AEs at least possibly related to Privigen®, including headache (8.3 %), fever, and chills (2.8 % each). No related serious AEs were reported. One infant with SCID died due to severe viral infection., Conclusions: Despite the heterogeneous population, effectiveness and tolerability of Privigen® in clinical practice closely matched those reported in clinical studies.

Background: Hypersensitivity disorders following vaccinations are a cause for concern., Objective: To determine the type and rate by age, gender, and vaccine received for reported hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines., Design: A systematic review of reports to the Vaccine Adverse Event Reporting System (VAERS) following monovalent 2009 pandemic influenza A (H1N1) vaccines., Setting/patients: US Civilian reports following vaccine received from October 1, 2009 through May 31, 2010., Measurements: Age, gender, vaccines received, diagnoses, clinical signs, and treatment were reviewed by nurses and physicians with expertise in vaccine adverse events. A panel of experts, including seven allergists reviewed complex illnesses and those with conflicting evidence for classification of the event., Results: Of 1984 reports, 1286 were consistent with immediate hypersensitivity disorders and 698 were attributed to anxiety reactions, syncope, or other illnesses. The female-to-male ratio was ≥4:1 for persons 20-to-59 years of age, but approximately equal for children under 10. One hundred eleven reports met Brighton Collaboration criteria for anaphylaxis; only one-half received epinephrine for initial therapy. The overall rate of reported hypersensitivity reactions was 10.7 per million vaccine doses distributed, with a 2-fold higher rate for live vaccine., Limitations: Underreporting, especially of mild events, would result in an underestimate of the true rate of immediate hypersensitivity reactions. Selective reporting of events in adult females could have resulted in higher rates than reported for males., Conclusions: Adult females may be at higher risk of hypersensitivity reactions after influenza vaccination than men. Although the risk of hypersensitivity reactions following 2009 pandemic influenza A (H1N1) vaccines was low, all clinics administering vaccines should be familiar with treatment guidelines for these adverse events, including the use of intramuscular epinephrine early in the course of serious hypersensitivity reactions., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between 2009 and 2013., Methods: Vaccine Adverse Event Reporting System received reports of adverse events following immunization (AEFI) after H1N1 vaccination. Selected reports were referred to the Centers for Disease Control and Prevention's Clinical Immunization Safety Assessment network for additional review. We assessed causality using modified World Health Organization criteria., Results: There were 3,928 reports of AEFI in children younger than age 18 years after 2009 H1N1 vaccination received by January 31, 2010. Of these, 214 (5.4%) were classified as serious nonfatal and 109 were referred to Clinical Immunization Safety Assessment for further evaluation. Ninety-nine (91%) had sufficient initial information to begin investigation and are described here. The mean age was 8 years (range, 6 months-17 years) and 38% were female. Median number of days between vaccination and symptom onset was 2 (range, -11 days to +41 days). Receipt of inactivated, live attenuated, or unknown type of 2009 H1N1 vaccines was reported by 68, 26 and 5 cases, respectively. Serious AEFI were categorized as neurologic events in 47 cases, as hypersensitivity in 15 cases and as respiratory events in 10 cases. At the time of evaluation, recovery was described as complete (61), partial (16), no improvement (1), or unknown (21). Causality assessment yielded the following likelihood of association with 2009 H1N1 vaccination: 8 definitely; 8 probably; 21 possibly; 43 unlikely; 17 unrelated; and 2 unclassifiable., Conclusions: Most AEFI in children evaluated were not causally related to vaccine and resolved without sequelae. Detailed clinical assessment of individual serious AEFI can provide reassurance of vaccine safety.

Pragmatic clinical trials (PCTs) seek to improve the generalizability and increase the statistical power of traditional explanatory trials. They are a major tenet of comparative effectiveness research. While a powerful study design, PCTs have been limited by high cost, modest efficiency, and limited ability to fill relevant evidence gaps. Based on an American Reinvestment and Recovery Act (ARRA) supported meeting of national stakeholders, we propose several innovations and future research that could improve the efficiency and effectiveness of such studies focused in the U.S. Innovations discussed include optimizing the use of community based practices through partnership with Practice Based Research Networks (PBRNs), using information technology to simplify PCT subject recruitment, consent and randomization processes, and utilizing linkages to large administrative databases, such as Medicare, as a mechanism to capture outcomes and other important PCT variables with lower subject and research team burden. Testing and adaptation of such innovations to PCT are anticipated to improve the public health value of these increasingly important studies., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Introduction: Body mass index (BMI) and indicators of central adiposity have been associated with cardiovascular disease (CVD) risk factors, but ambiguity remains about which measure optimally predicts CVD risk and is best suited for different racial/ethnic groups. We sought to characterize excess adiposity among New York City adults and assess the potential associations between multiple adiposity indicators and CVD risk factors, by race/ethnicity., Methods: The New York City Health and Nutrition Examination Survey (NYC HANES) is a population-based survey of noninstitutionalized New York City adult residents aged 20 years or older. We compared the prevalence of obesity (BMI ≥ 30 kg/m(2)), elevated waist circumference (>102 cm for men, >88 cm for women), and elevated waist-to-height ratio (≥ 0.5) for participants in the 2004 NYC HANES (n = 1,912) and the 2003-2004 National Health and Nutrition Examination Survey (n = 4,075). Logistic regression was used to assess potential associations between each of these indicators of excess adiposity and CVD risk factors (diabetes, impaired fasting glucose, hypertension, and hypercholesterolemia), overall and by race/ethnicity., Results: The prevalence of obesity among NYC HANES participants was 26% and of elevated waist circumference was 46%, both significantly lower than national estimates (31% and 52%, respectively), whereas the prevalence of elevated waist-to-height ratio was higher (82% vs 79%). Most measures of excess adiposity were significantly associated with all CVD risk factors. No single measure of excess adiposity emerged as most consistently predictive of CVD risk in the general population or by race/ethnicity., Conclusion: New York City has a lower prevalence of obesity and elevated waist circumference but a higher prevalence of elevated waist-to-height ratio than found nationally. Further investigation into the optimal adiposity measure to predict CVD risk across racial/ethnic populations may be warranted.

Bioavailability and pharmacokinetics of subcutaneous IgG (SCIG) and intravenous IgG (IVIG) differ. It is not clear if and/or how the dose should be adjusted when switching from IVIG to SCIG. Area under the curve (AUC) of serum IgG versus time and trough level ratios (TLRs) on SCIG/IVIG were evaluated as guides for adjusting the dose. The mean dose adjustments required for non-inferior AUCs with 2 different SCIG preparations were 137% (± 12%) and 153% (± 16%). However, there were wide variations between adjustments required by different subjects, and in the resulting TLRs. In contrast, combined data from multiple studies allow estimation of the ratio of IgG levels with different dose adjustments, and of the steady state serum levels with different SCIG doses. When switching a patient from IVIG to SCIG, individualizing the dosage based on measured serum IgG levels and the clinical response is preferable to using mean pharmacokinetic parameters., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Rapid technological growth in the field of ligature-resistant locking to better secure patients who are at high risk of harming themselves or the staff members caring for them presents a critical range of options and decisions for product decision makers and specifiers in Behavioral Healthcare. In this article, the author, a leader in the electronic locking industry, reviews the factors to be aware of in selecting such systems for psychiatric patients including security, liability, and privacy; the quality and performance of each product; and the means of egress requirements or ease of operation for both patients and staff in different situations, including entering a room quickly or exiting a room in the event of the need for emergency evacuation.

Doctors, patients, and other decision makers need access to the best available clinical evidence, which can come from systematic reviews, experimental trials, and observational research. Despite methodological challenges, high-quality observational studies have an important role in comparative effectiveness research because they can address issues that are otherwise difficult or impossible to study. In addition, many clinical and policy decisions do not require the very high levels of certainty provided by large, rigorous randomized trials. This paper provides insights and a framework to guide good decision making that involves the full range of high-quality comparative effectiveness research techniques, including observational research.

Faced with the time-consuming responsibility of human resources (HR) management, a growing number of medical practices are outsourcing their HR to professional employer organizations (PEOs) so they can concentrate on their core business. A PEO functions as an HR department-minus the high overhead-managing daily administrative tasks such as payroll processing and related tax filings, employee benefits, and workers' compensation coverage and claims resolution. PEOs help physicians' offices keep up with the piles of paperwork that never seem to shrink, freeing doctors to focus on patient care and building their practice. Because of their volume buying power, PEOs are able to offer employees of small medical practices big-company benefits-everything from health, dental, and vision coverage to long-term disability insurance and tuition assistance. A fledgling industry only a decade ago, HR outsourcing has morphed into a blossoming industry. Enlisting the services of a PEO is now considered de rigueur in many small business circles.

The lifelong IgG replacement therapy for patients with primary immunedeficiencies (PIDD) may be provided by intravenous (IVIG) or by subcutaneous IgG (SCIG) infusions. We investigated the impact of weekly SCIG self-infusions at home on the health-related quality of life, treatment satisfaction, and preferences in patients treated with IVIG at the hospital/doctor's office (Group A) or at home (Group B) before the study started. Forty-four adult North American PIDD patients were included in the study, 28 patients in Group A and 16 in Group B. Patients in Group A reported significantly less limitations with their work/daily activities, a significantly improved vitality, and better general health. Treatment satisfaction was significantly improved in Group A. The preference for the subcutaneous route and for home therapy was respectively 81% and 90% in Group A. In Group B, 69% preferred the subcutaneous route and 92% home therapy.

Since the introduction of the implantable cardioverter defibrillator (ICD) for the management of patients with high risk of arrhythmic SCD, there has been increasing use of this device. Its basic promise to effectively terminate ventricular tachycardia (VT)-ventricular fibrillation (VF) has been repeatedly met. In several randomized trials, the ICD has been shown to be superior to conventional anti-arrhythmic therapy, both in patients with documented VT-VF (secondary prevention) and those with high risk such as left ventricular ejection fraction and no prior sustained VT-VF (primary prevention). In both groups, the ICD showed overall and cardiac mortality reduction. The device now can more accurately detect VT-VF and differentiate these from other arrhythmias through a series of algorithms and direct-chamber sensing. Therapy options include painless antitachycardia pacing, low-energy cardioversion, and high-energy defibrillation. The technique implant is now simple as a pacemaker with one lead attached to an active (hot) can functioning as the other electrode. Among other improvements is its weight, volume, multiprogrammability, and storage of information,dual-chamber pacing and sensing, dual-chamber defibrillation, and addition of biventricular pacing for cardiac synchronization. It is anticipated that further improvement in ICD technology will take place and the list of indications will grow.

Purpose: This paper investigates the impact of quality-of-life adjustment on cost-effectiveness analyses, by comparing ratios from published studies that have reported both incremental costs per (unadjusted) life-year and per quality-adjusted life-year for the same intervention., Methods: A systematic literature search identified 228 original cost-utility analyses published prior to 1998. Sixty-three of these analyses (173 ratio pairs) reported both cost/LY and cost/QALY ratios for the same intervention, from which we calculated medians and means, the difference between ratios (cost/LY minus cost/QALY) and between reciprocals of the ratios, and cost/LY as a percentage of the corresponding cost/QALY ratio. We also compared the ratios using rank-order correlation, and assessed the frequency with which quality-adjustment resulted in a ratio crossing the widely used cost-effectiveness thresholds of 20, 000 US dollars, 50,000 US dollars, and 100,000 US dollars/QALY or LY., Results: The mean ratios were 69,100 US dollars/LY and 103,100 US dollars/QALY, with corresponding medians of 24,600 US dollars/LY and 20,400 US dollars/QALY. The mean difference between ratios was approximately -34,300 US dollars (median difference: 1300 US dollars), with 60% of ratio pairs differing by 10,000 US dollars/year or less. Mean difference between reciprocals was 59 (QA)LYs per million dollars (median: 2.1). The Spearman rank-order correlation between ratio types was 0.86 (p<0.001). Quality-adjustment led to a ratio moving either above or below 50,000 US dollars/LY (or QALY) in 8% of ratio pairs, and across 100,000 US dollars in 6% of cases., Conclusions: In a sizable fraction of cost-utility analyses, quality adjusting did not substantially alter the estimated cost-effectiveness of an intervention, suggesting that sensitivity analyses using ad hoc adjustments or 'off-the-shelf' utility weights may be sufficient for many analyses. The collection of preference weight data should be subjected to the same scrutiny as other data inputs to cost-effectiveness analyses, and should only be under-taken if the value of this information is likely to be greater than the cost of obtaining it., (Copyright 2004 John Wiley & Sons, Ltd.)

Objective: Positron emission tomography (PET) is a high-cost imaging tool primarily used in oncology, cardiology, and neuropsychiatry. Accurate estimates of the cost of PET are needed to assess its cost effectiveness and determine the appropriate role for this modality in clinical applications. We performed a survey-based cost analysis of PET with FDG by estimating direct, indirect, and capital costs from eight PET centers. A breakdown of the operational budget of PET centers and FDG-compounding facilities is presented along with the costs per scan. Differences in costs between sites that purchase FDG and those that manufacture FDG are also examined., Materials and Methods: We sent surveys to managers of eight Veterans Affairs and two non-Veterans Affairs PET scanning and FDG-compounding facilities. The survey included questions about service volume and the direct costs of equipment, personnel, space, supplies, and repairs needed for FDG compounding and PET scanning and interpretation. We estimated the indirect costs associated with FDG compounding, PET scanning, and PET interpretation., Results: Of the eight sites that responded to our survey, three sites manufacture FDG on-site, three sites purchase FDG, and two sites do both. The total mean cost per scan using manufactured FDG is 1885 US dollars, and it is 1898 US dollars using purchased FDG., Conclusion: PET is expensive. The cost is similar when FDG is manufactured or purchased. Because both PET and cyclotron facilities have high fixed costs, increasing the number of scans obtained and the number of FDG doses manufactured may lead to a decrease in unit costs.

Processes for the large-scale fractionation of human plasma using cold ethanol were initially developed by Edwin Cohn and his colleagues at Harvard to provide albumin as a treatment for shock in World War II. Procedures for further purification of gamma globulins and other proteins precipitating at lower concentrations of ethanol were then developed by Oncley et al. Gamma globulin rapidly replaced convalescent and animal sera for the prevention and treatment of infectious diseases such as measles, hepatitis, and polio, then came into widespread use as replacement therapy in the primary immune deficiencies, which emerged in the antibiotic era of the early 1950s. Although it took 40 years to develop preparations of gamma globulin that could be safely given intravenously, the eventual accomplishment of that goal has led to better treatment of antibody deficiency syndromes and also the wide use of high-dose intravenous immunoglobulin in autoimmune and inflammatory diseases. Those uses continue to expand even as monoclonal antibodies are being introduced for specific infectious diseases in high-risk populations.

Introduction: Tumor registries capture valid information at the time of cancer diagnosis, but often do not conduct longitudinal follow-up evaluations. However, investigators may be interested in questions relating to subsequent relapsed disease. Linking administrative data to registry data, as in the creation of the SEER (Surveillance, Epidemiology, and End Results) and Medicare data set, can provide the ability to infer the occurrence of relapse in selected situations., Methods: The authors created different algorithms to detect relapse of acute myelogenous leukemia (AML). A retrospective cohort of patients with AML was identified, and both their billing data and medical records were obtained. The algorithms were then applied to the billing data, the results were compared with medical record review., Results: Eighty-nine patients were identified, of whom 22 were treated for relapsed AML. The sensitivity of the best algorithm for detecting relapse was 86%, and the specificity 99%, with a positive predictive value of 95% and a negative predictive value of 96%., Conclusions: Identification of relapse from SEER-Medicare data using clinical algorithms is feasible for cancers where a majority of patients receive treatment for relapse, without a "watch and wait" strategy, and where that treatment is with a modality that can be detected in billing data (ie, intravenous chemotherapy, radiation, surgery, or all three). Optimal analytic situations are ones in which the investigator is mostly interested in positive predictive value, less interested in sensitivity, and wants to evaluate outcomes among those patients who receive treatment for their relapsed disease. However, the accuracy of such an approach for cancers other than AML has not yet been established.

Researchers have sought therapeutic applications for monoclonal antibodies since their development in 1975. However, murine-derived monoclonal antibodies may cause an immunogenic response in human patients, reducing their therapeutic efficacy. Chimeric and humanized antibodies have been developed that are less likely to provoke an immune reaction in human patients than are murine-derived antibodies. Antibody fragments, bispecific antibodies, and antibodies produced through the use of phage display systems and genetically modified plants and animals may aid researchers in developing new uses for monoclonal antibodies in the treatment of disease. Monoclonal antibodies may have a number of promising potential therapeutic applications in the treatment of asthma, autoimmune diseases, cancer, poisoning, septicemia, substance abuse, viral infections, and other diseases.

In March 1997, a transition occurred in the health service support of the intermediate staging base of Operation Joint Guard in Taszar, Hungary, by which a level III, 32-bed Deployable Medical Systems facility staffed by 178 personnel was replaced by a level II+ clinic staffed by 48 personnel with no organic surgical or blood transfusion capabilities. This was achieved by the use of local host nation facilities for surgery, sophisticated diagnostics, and medical specialty hospitalization. In the ensuing 7 months, 34 American patients were admitted to Hungarian hospitals for a total of 100 inpatient days, and 8 of them underwent surgery. This successful use of host nation facilities as medical force multipliers allowed great savings in cost and personnel and should be considered in future operations other than war that involve low-intensity conflict.

Medical Readiness Training Exercises (MEDRETEs) can be a valuable training tool for U.S. Army personnel in remote areas of deployment. We report our experience of the MEDRETE in El Salvador in 1996. Working with foreign physicians of the host country was a positive experience in which we learned local customs and mutual cooperation. Evaluation and treatment of nearly 6,000 patients increased goodwill in the community and provided an opportunity for teamwork for Army Reserve medical units, including increased discussions of public health issues. We also report on the field applicability of the advanced laboratory and pharmacy equipment we included in our training.

NORA is an observational registry of postmenopausal US women with periodic collection of event and treatment data that will create a database including several hundred thousand subjects. It will utilize peripheral and central measurements of bone density and relate these to other risk factors, treatment patterns, and the natural history of osteoporosis. Initiated in the fall of 1997, the registry will be open to women throughout the United States who agree to complete baseline and on-going surveys. The database created by NORA will provide a resource that is unmatched in size and scope in the medical field and will allow for future research in a number of areas including patient outcomes, types of follow-up employed in clinical practice, diagnostic cost modelling, and osteoporosis therapy use (type, patient compliance, persistence and satisfaction). In addition, upon approval by the Steering Committee, women enrolled in the registry may be randomly selected to receive additional educational materials or questionnaires on a variety of topics of interest to specific researchers.

The membership of the Pediatric Section of the American Association of Neurological Surgeons was surveyed with regard to attitudes in current practice in the treatment of Chiari malformations Types I and II. Ninety-six of 152 (63%) valid questionnaires were returned. The median number of malformations treated yearly by the respondents was 3 for Type I and 6 for Type II. There was substantial agreement that surgery should not be carried out on asymptomatic patients and that surgery was indicated for the treatment of brain stem dysfunction, cranial nerve dysfunction,, hydromyelia, and scoliosis associated with these malformations. There was substantial disagreement about lesser indications for surgery. The respondents also expressed dissatisfaction with the current classification of Chiari malformations. Chiari malformations are complex abnormalities, and their anatomy is being better delineated with magnetic resonance imaging. Carefully designed scientific clinical investigations are needed to improve our understanding and treatment of Chiari malformations.

To a large extent,the principles of dietary management of children and adults with chronic renal failure are similar. Certainly, both require some degree of protein restriction to prevent the adverse effects that occur when uremic manifestations are present; the need for calories--to allow for adequate growth--is extremely important to uremic children. It is of lesser importance to adults. However, its strategic importance to children cannot be overemphasized and needs to be fully appreciated by dietitians who are increasingly being called on to care for uremic children referred to adult dialysis units.

We have conducted a cross-cultural (USA and USSR) comparison of thermal biofeedback (TBF) and autogenic training (AT) to a self-relaxation control condition in 59 unmedicated males with mild hypertension. Identical assessment and treatment protocols were carried out in both settings (Albany, New York, and Moscow). Treatments were delivered in small groups on an outpatient basis twice per week for 10 weeks. Results showed comparable, significant (p less than .05), short-term decreases (M = 8.5 mm Hg) in diastolic blood pressure (DBP) for both treatments at both sites. However, the Soviet patients, starting with significantly (p less than .01) higher systolic blood pressures (SBPs), showed significant decreases (M = 12.8 mm Hg) in SBP, whereas the American patients did not change appreciably (M = 4.6 mm Hg). During follow-up, the treated Soviet patients showed significantly (p less than .05) better maintenance of treatment effects, from 3 months to 1 year, than did the American patients. At 1 year, 75% of the treated Soviet patients had DBPs less than 90 mm Hg, whereas only 24% of the American patients had comparable DBPs.

Cardiovascular reactivity (heart rate, systolic, and diastolic BP) to mental arithmetic and cold pressor were measured before and after treatment as part of the cross-cultural (USSR and USA) evaluation of thermal biofeedback and autogenic training (in comparison with self-relaxation) as treatments for mild hypertension in unmedicated males. There were no statistically reliable decreases in cardiovascular reactivity from before to after treatment. However, downward shifts in basal levels of systolic and diastolic BP at post-treatment led treated patients to have lower stress-induced levels of BP.