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PubMedDate not supplied

Predictive value of primate models for AIDS.

A number of obstacles remain in the search for an animal model for HIV infection and pathogenesis that can serve to predict efficacy in humans. HIV-1 fails to replicate and cause disease except in humans or chimpanzees, thereby limiting our ability to evaluate compounds or vaccines prior to human testing. Despite this limitation, nonhuman primate lentivirus models have been established that recapitulate the modes of infection, disease course, and antiviral immunity that is seen in HIV infection of humans. These models have been utilized to understand key aspects of disease and to evaluate concepts in therapies and vaccine development. By necessity, animal models can only be validated after successful trials in humans and the determination of correlates of protection. Because the only vaccine product tested in phase III trials in humans failed to achieve the desired protective threshold, we are as yet unable to validate any of the currently used nonhuman primate models for vaccine research. In the absence of a validated model, many experts in the field have concluded that prophylactic vaccines and therapeutic concepts should bypass primate models, and rely solely upon the systematic testing of each individual and combined vaccine element in human phase I or I/II trials to determine their relative merits. Indeed, a large effort is underway to expand efforts to test all products as part of an international effort termed "The HIV Vaccine Enterprise", with major contributions from the Bill and Melinda Gates Foundation. This Herculean task could potentially be reduced if it were possible to utilize even partially validated nonhuman primate models as part of the screening efforts. The purpose of this article is to review the data from nonhuman primate models that have contributed to our understanding of lentivirus infection and pathogenesis, and to critically evaluate how well these models have predicted outcomes in humans. Key features of the models developed to date are described and their contributions to HIV pathogenesis, therapeutics, and vaccines, are compared. This analysis shows that many of the models at hand have yielded data on drug action and immune responses to vaccines that are congruent with clinical data. This finding suggests that primate models are valuable as adjunctive testing systems to prioritize future therapeutic and vaccine strategies. Nonhuman primate testing of vaccine approaches in particular has provided valuable information and can significantly enhance and accelerate the evaluation of novel concepts necessary to achieve acceptable levels of efficacy. Because major gaps remain in the quest for fully effective vaccines and therapies, it seems prudent to continue aggressive research programs in the nonhuman primate models.

AIDS Vaccines↗

PubMed2004

HLA-A2-restricted CD8+-cytotoxic-T-cell responses to novel epitopes in Mycobacterium tuberculosis superoxide dismutase, alanine dehydrogenase, and glutamine synthetase.

Major histocompatibility complex class I-restricted CD8(+) cytotoxic T lymphocytes (CTL) are implicated in protective Th1 immunity to Mycobacterium tuberculosis infection. We report the identification of three novel HLA-A*0201-restricted CTL epitopes within mycobacterial superoxide dismutase (SodA), L-alanine dehydrogenase (AlaDH), and L-glutamine synthetase (GlnS) proteins.

Alanine Dehydrogenase↗

PubMed1992

Asbestos-containing materials in New York City buildings.

The New York City Department of Environmental Protection (DEP) carried out a survey to assess the public's risk of exposure in buildings to in-place asbestos-containing materials (ACM). Data regarding the presence of in-place asbestos and the potential for exposure to asbestos were collected in 886 buildings from 16 different building categories in New York City. Overall 68% of the buildings in New York City contain ACM. The estimated total amount of ACM in the city is 323 million ft2 most of which is thermal system insulation. Overall, 16% of all ACM had greater than 10% of its surface damaged and another 68% of ACM had some, but less than 10% of its surface damaged. About half of all ACM is in mechanical spaces within buildings. On the basis of results of the survey, buildings in New York City were prioritized for management and an in-place management bill was introduced into the New York City Council.

Air Pollution, Indoor↗

PubMedDate not supplied

Gerontologic nurse practitioner care guideline: COPD in the older adult.

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Aged↗

PubMed1988

Peptic ulcer complications and how to treat them.

The main complications to peptic ulcer are perforation, stenosis and bleeding. Diagnosis and treatment are discussed with special reference to the principles of 1st Department, Kommunehospitalet, Copenhagen. The three main complications to peptic ulcer disease include perforation, stenosis and bleeding. The etiology to peptic ulcer disease and the pathogenesis of ulcer disease complications are still poorly understood, although an imbalance between mucosa-protecting and -destructing factors seems to be of major importance. However, the introduction of neither H2 receptor antagonists nor the so-called mucosaprotection agents during the seventies and eighties significantly have reduced the frequency of peptic ulcer disease or the frequency of its complications (perforation 10 per cent, stenosis 10 per cent and bleeding 20 per cent of patients with peptic ulcer disease. The unchanged frequency of operation for peptic ulcer complications was confirmed in a recent study by A. Christensen et al. 1987. Their data suggested unchanged frequency of operations for ulcer complications prior to and following the introduction of H2 receptor antagonists (Fig. I and II) in a well defined population in Copenhagen.

Humans↗

PubMed1997

Evaluation of a worksite injury and illness prevention program: do the effects of the REACH OUT training program reach the employees?

In this article the authors report the findings of a 2-year study evaluating the effectiveness of REACH OUT, a train-the-trainer program developed to assist small businesses comply with California legislation, Senate Bill 198 (1989), requiring employees to implement a worksite Injury and Illness Prevention Program. Data from a case study sample of 8 companies, drawn from 151 Southern California small businesses participating in the larger study, are reported. Diagnostic walk-throughs were performed, and employee surveys collected at the case study companies approximately 2 months before the treatment group received the intervention and again 1 year later. Results indicate that greater corporate compliance led to employees' perceptions of increased health and safety meetings and training sessions, which led to greater employee health and safety knowledge and improved employee health outcomes.

Accidents, Occupational↗

PubMed2004

Worker exposure standard for phosphine gas.

The 1998 U.S. Environmental Protection Agency Office of Pesticide Programs (OPP) re-registration eligibility decision (RED) for phosphine fumigants has generated much interest in defining safe levels of exposure for workers and worker bystanders. This report summarizes the pertinent literature on phosphine toxicity, including animal inhalation studies and human epidemiology studies, and also describes a margin-of-exposure (MOE) analysis based on available worker exposure data. In addition, a safe occupational exposure limit is estimated using typical OPP assumptions, after determination of appropriate uncertainty factors, based on quality of data in the principal study and pharmacokinetic considerations. While a conservative 8-hour time-weighted average (TWA) of 0.1 ppm was calculated, the overall weight of evidence, from a risk-management perspective, supports a conclusion that an occupational TWA of 0.3 ppm provides adequate health protection. In addition, a 15-minute short-term exposure limit (STEL) of 3 ppm was estimated. Finally, in contrast to the MOE analysis described in the OPP's phosphine RED, the MOE analysis described herein does not indicate that fumigation workers are currently being exposed to unacceptable levels of phosphine. Collectively, these findings support the occupational exposure limits of 0.3 ppm (8-hour TWA) and 1 ppm (STEL) established in the updated applicator's manuals for phosphine-generating products, which recently received approval from OPP.

Administration, Inhalation↗

PubMed2003

Adolescent health care expenditures: a descriptive profile.

PURPOSE: To examine health care spending patterns for U.S. adolescents aged 10 to 18 years using nationally representative household survey data. METHODS: We analyzed data from the 1997 Medical Expenditure Panel Survey on total expenditures and out-of-pocket expenditures for health care based on a sample of 4882 adolescents. RESULTS: Compared with that for adults, health care expenditures for adolescents were low, averaging $799 US dollars per adolescent in 1997. Disabled and functionally impaired adolescents had disproportionately high expenditures ($1960 US dollars per capita). Blacks and adolescents living in poor families had disproportionately low expenditures ($358 and $609 US dollars per capita, respectively). Professional services provided by physicians and dentists accounted for more than one-half of all health care spending for adolescents. Only 2% of adolescents were hospitalized in 1997, but they accounted for about one-fifth of all health care expenditures. The share of health expenditures paid out of pocket varied by type of service, ranging from 3% for inpatient hospital care to 51% for dental care. When covered, insurance provided substantial financial protection for families of adolescents: those with public coverage paid 8%, those with private coverage paid 32%, and those without coverage paid 61% of their health care bills out of pocket. The share of health care bills paid out of pocket would be much lower if dental care was excluded. CONCLUSIONS: On the basis of our findings that health care expenditures for adolescents are low and that insurance coverage provides critically needed financial protection, we conclude that further expansions of public and private health insurance coverage for this population would provide significant benefits at modest additional cost. Additional efforts to improve coverage of services that are not now well-covered, such as dental care, would also be valuable.

Adolescent↗

PubMed2005

Delayed rectal and urinary symptomatology in patients treated for prostate cancer by radiotherapy with or without short term neo-adjuvant androgen deprivation.

BACKGROUND AND PURPOSE: To identify contributing factors to delayed rectal and urinary symptoms in a randomised trial comparing different durations of maximal androgen deprivation (MAD), given prior to radiotherapy, for locally advanced prostate cancer. PATIENTS AND METHODS: Between 1996 and 2000, 818 patients with stages T2b,c, 3 and 4 prostate cancer were entered into a trial comparing 0, 3 and 6 months of MAD prior to and during radiotherapy. Their delayed normal tissue effects were recorded by their treating doctors using standardised scales and by the patients using a self-assessment questionnaire regularly. Time to occurrence and prevalence data were analysed. RESULTS: Rectal and urinary symptom levels were observed to vary markedly over time in at least 80% of patients, with some indicating lasting resolution of symptoms. Prevalence rates were found to be substantially lower than actuarial probability rates. Baseline symptom levels and greatest acute symptom levels were both very powerful predictors. Obstructive lower urinary tract symptoms were noted to improve during the first 4 years after radiotherapy in approximately 60% of cases in each treatment arm. However, the treatment arm itself was not shown to influence these improvements in other univariate or multivariate analyses. MAD was shown to reduce both time to occurrence and prevalence of delayed proctopathic symptoms, but this effect was confirmed statistically in the 3 month treatment arm only. Multivariate models indicated that higher levels of haemoglobin prior to any treatment may in some way protect against delayed proctopathic symptoms. CONCLUSIONS: Prevalence data provide more clinically meaningful estimates of risk of delayed effects in normal tissues where assessment relies substantially on reported symptom levels. In these tissues consideration of the impact of baseline symptom levels and pathologies, and greatest acute symptom levels in analyses of delayed effects appears mandatory. Obstructive lower urinary symptoms improve over several years in the majority of patients treated for locally advanced prostate cancer by radiotherapy. Future research could address whether rectal toxicity is affected by initial haemoglobin levels and declines in it due to MAD.

Age Factors↗

PubMed1996

Sources of health insurance and characteristics of the uninsured. Analysis of the March 1996 Current Population Survey.

This Issue Brief provides summary data on the insured and uninsured populations in the nation and in each state. It discusses the way health protection has changed for the insured, how the states rank in health insurance protection, and the characteristics most closely related to whether or not an individual is likely to have health insurance. The report is based on Employee Benefit Research Institute analysis of the March 1996 supplement to the Current Population Survey (CPS) and represents the most recent data available. In 1995, there were 231.9 million civilian, nonelderly Americans in the United States, 163.9 million (70.7 percent) of whom were covered by private health insurance. Almost 148 million individuals (63.8 percent) were covered by an employment-based plan. Over 38.4 million individuals (16.6 percent) were covered by publicly financed health insurance, and 29 million (12.5 percent) were covered by Medicaid. In 1995, 17.4 percent of the nonelderly population, or 40.3 million individuals, were not covered by health insurance. This is an increase from 39.4 million, or 17.1 percent, in 1994. In general, the percentage of the population without health insurance has been increasing. In 1988, 15.2 percent of the U.S. population was uninsured. The 104th Congress passed the Health Insurance Portability and Accountability Act of 1996 in the interest of making health care more portable and affordable. Additional legislation was passed addressing mental health benefits and maternity length of stay. These bills will do little to decrease the size of the uninsured population. They include provisions for group-to-group portability, group-to-individual portability, an increase in the self-employed health deduction, medical savings accounts, mental health parity, and minimum length-of-stay requirements for childbirth. These provisions in large part benefit individuals who already have health insurance. They do not directly address the larger problem of its affordability. Data from the Survey of Income and Program Participation indicate that 50.7 million individuals lacked health insurance coverage for at least one month during calendar year 1992. Approximately 43 percent were uninsured between one and four months. The median spell without health insurance was six months. These data would seem to indicate that even though many individuals may lose health insurance during any given month, the majority are uninsured for a short period of time.

Adolescent↗

PubMed1987

Seasonal variation in intake of carotenoids and vegetables and fruits among white men in New Jersey.

In a population-based case-control study of lung cancer among New Jersey men, usual adult consumption of many vegetables and fruits was included in the interview to assess the protective potential of carotenoids. With data from 900 controls the percentage of New Jersey white men who eat specific vegetables and fruits primarily in certain seasons, the relative importance of in-season and out-of-season consumption, and the median length of season were determined. Although first asking whether a food item was consumed all-year-round or primarily in certain seasons and then asking for the appropriate frequency of consumption facilitated the interview, obtaining out-of-season frequency of consumption and length of season was not necessary. Substituting 0 for reported out-of-season frequencies and 3 mo for reported season lengths reduced slightly the observed associations between diet and lung cancer risk but did not modify the overall pattern noted. Carotenoid intake in winter-fall was estimated to be about two-thirds that in summer-spring.

Adult↗

PubMed1999

Safety needles. New requirements of the Occupational Safety and Health Administration bloodborne pathogens rule.

In September 1998, a California Assembly bill was signed into law that requires significant changes to the Cal/OSHA Bloodborne Pathogens Standard. As of July 1, 1999, all health care employers in the state must begin providing sharps safety devices. For dentistry, this means a shift from the traditional needles to safety needles with engineered built-in safety mechanisms. Some exceptions are provided in this new regulatory change. There is no reliable data on the safety and efficacy of the available devices. This article explores the regulatory changes and begins to provide information on the devices available. Design features, usability by the practitioner, and safety to the patient are important issues to consider when deciding whether these devices are appropriate for dental anesthesia. Most practitioners will find it difficult to conduct an independent evaluation and must rely on information in the professional literature to help guide their decisions.

Blood-Borne Pathogens↗

PubMed2002

Clerkship directors' perceptions of the impact of HCFA documentation guidelines.

PURPOSE: Chart notes are used to support billing codes under the evaluation and management guidelines of the Health Care Financing Administration (HCFA), in addition to serving as a record of the visit. To better understand the effect of the HCFA documentation guidelines, the authors collected data on how the guidelines affect participation by university- and community-based faculty in clinical education programs. METHOD: In 2000, the authors sent six copies of their questionnaire to the associate deans of the 125 U.S. medical schools and requested they distribute them to all core clerkship directors. The questionnaire consisted of multiple-choice and short-answer questions regarding documentation of medical visits, participation of community-based faculty, understanding of HCFA documentation guidelines, and effects on education programs. RESULTS: The response rate was about 50%. Most of the 379 clerkship directors who responded (77%) stated they were aware the HCFA documentation guidelines include specifications regarding the role medical students can play and documentation of medical visits, and 64% indicated they were concerned the guidelines would affect their educational programs. Concerns included the loss of student independence and active participation in the patient care environment (37), time constraints and the changing balance between education and service (16), loss of faculty and decreased morale (11), and decreased quality of care for patients (7). CONCLUSION: Leaders of medical education must work to modify these guidelines to protect the quality of patients' care, while maximizing students' educational opportunity and participation.

Centers for Medicare and Medicaid Services, U.S.↗

PubMed2002

Regulation of IL-1beta -induced GM-CSF production in human airway smooth muscle cells by carbon monoxide.

Asthma, a chronic inflammatory disease of the airways, involves the increased expression of inflammatory mediators, including granulocyte-monocyte colony-stimulating factor (GM-CSF). Heme oxygenase-1 (HO-1), a stress-response protein, confers protection against oxidative stress. We hypothesized that carbon monoxide (CO), a byproduct of HO-1-dependent heme catabolism, regulates GM-CSF synthesis in human airway smooth muscle cells (HASMC). IL-1beta treatment induced a time-dependent induction of GM-CSF in HASMC. Furthermore, IL-1beta stimulated the major MAPK pathways, including ERK1/ERK2, JNK, and p38 MAPK. Exposure of HASMC to CO at low concentration (250 ppm) markedly inhibited IL-1beta-induced GM-CSF synthesis (>90%) compared with air-treated controls. CO treatment inhibited IL-1beta-induced ERK1/2 activation but did not inhibit JNK and p38 MAPK. Furthermore, CO increased cGMP levels in HASMC. Inhibition of guanylate cyclase by IH-[1,2,4] oxadiazolo[4,3-a]quinoxalin-1-1 (ODQ) abolished the inhibitory effects of CO on GM-CSF synthesis and ERK1/2 activation. Collectively, these data demonstrate that the inhibitory effect of CO on GM-CSF synthesis depends on ERK1/2 MAPK and guanylate cyclase/cGMP-dependent pathways.

Carbon Monoxide↗

PubMed1991

A diaphragm tampon applied to an ovulation method in a birth control system.

Gynaeseal is a re-usable diaphragm tampon made from latex which forms a unique cervico-vaginal seal and isolates menstrual loss. In a prospective study involving 80 women, Gynaeseal was offered in combination with the Billings Ovulation Method in an advised birth control system. This system included: use of the diaphragm tampon during the menstruation-fertile phase interphase; periodic abstinence during the overtly fertile phase of the cycle; and if extreme reliability was required, for a further 2 days after the Billings method 'rules' allow resumption of intercourse. The diaphragm tampon successfully complemented the Billings Ovulation Method with 44 women (60.4%) assessing the GOM System as being as good, or better than, currently available reversible methods. It functioned effectively as a tampon with 50% (31 women) stating that they used the product as a contraceptive. One woman claimed an unplanned pregnancy. No significant medical complications were recorded. The product has major advantages as a tampon: it is easily and accurately inserted because of the efficient applicator; it isolated menstrual loss within a collection chamber; it protects the cervix; and it facilitates sexual activity. Based on a minimum effective diameter (62mm), the diaphragm tampon does not interfere with the normal physiology of the vagina. There appeared to be no significant distortion of normal adult pelvic anatomy, and properly placed, no sensation of the diaphragm tampon's presence. Regarding insertion of the diaphragm tampon using the spiral-curved applicator: 31 women (42.5%) had little or no difficulty; 29 (39.7%) moderate difficulty; 13 (17.8%) experienced serious difficulty; and 7 (8.7%) were unable to use the product.

Adolescent↗

PubMed2005

Diabetes is associated with dramatically decreased survival in female but not male subjects with cystic fibrosis.

OBJECTIVE: Survival analysis was performed on a prospectively followed cohort of patients with cystic fibrosis (CF) to determine the impact of the development of diabetes on survival. RESEARCH DESIGN AND METHODS: Clinical data were retrieved for patients diagnosed with CF-related diabetes (CFRD) at the Minnesota CF Center in 1987-2002. Kaplan-Meier survival analysis was performed to estimate median survival. Data were analyzed by Cox regression to evaluate the influence of clinical characteristics at the time of CFRD diagnosis on mortality. RESULTS: Clinical information was reviewed from 1,081 CF patients. A total of 123 patients with CFRD with fasting hyperglycemia were identified (58 males). Median survival was 49.5 years for male subjects without diabetes, 47.4 years for male subjects with diabetes, 47.0 years for female subjects without diabetes, and 30.7 years for female subjects with diabetes. Only female sex and forced expiratory volume in 1 s at the time of CFRD diagnosis were significant predictors of the subsequent risk of death (P < 0.001). This strong association was not confounded by CFTR genotype, BMI, steroid use, respiratory pathogens, HbA1c, or pregnancy. CONCLUSIONS: Female subjects with CFRD have a remarkably poorer prognosis compared with all male subjects with CF and female subjects with CF but without diabetes. The etiology of this sex difference is not clear. We speculate it might involve the interaction of female hormones and diabetes on promotion of a proinflammatory state or that androgens might protect male subjects from the catabolic effects of insulin deficiency. Alternatively, the appearance of frank diabetes in female subjects with CF may simply be a marker for some other biological difference that is not immediately apparent.

Adolescent↗

PubMed1999

Out-of-pocket health spending by poor and near-poor elderly Medicare beneficiaries.

OBJECTIVE: To estimate out-of-pocket health care spending by lower-income Medicare beneficiaries, and to examine spending variations between those who receive Medicaid assistance and those who do not receive such aid. DATA SOURCES AND COLLECTION: 1993 Medicare Current Beneficiary Survey (MCBS) Cost and Use files, supplemented with data from the Bureau of the Census (Current Population Survey); the Congressional Budget Office; the Health Care Financing Administration, Office of the Actuary (National Health Accounts); and the Social Security Administration. STUDY DESIGN: We analyzed out-of-pocket spending through a Medicare Benefits Simulation model, which projects out-of-pocket health care spending from the 1993 MCBS to 1997. Out-of-pocket health care spending is defined to include Medicare deductibles and coinsurance; premiums for private insurance, Medicare Part B, and Medicare HMOs; payments for non-covered goods and services; and balance billing by physicians. It excludes the costs of home care and nursing facility services, as well as indirect tax payments toward health care financing. PRINCIPAL FINDINGS: Almost 60 percent of beneficiaries with incomes below the poverty level did not receive Medicaid assistance in 1997. We estimate that these beneficiaries spent, on average, about half their income out-of-pocket for health care, whether they were enrolled in a Medicare HMO or in the traditional fee-for-service program. The 75 percent of beneficiaries with incomes between 100 and 125 percent of the poverty level who were not enrolled in Medicaid spent an estimated 30 percent of their income out-of-pocket on health care if they were in the traditional program and about 23 percent of their income if they were enrolled in a Medicare HMO. Average out-of-pocket spending among fee-for-service beneficiaries varied depending on whether beneficiaries had Medigap policies, employer-provided supplemental insurance, or no supplemental coverage. Those without supplemental coverage spent more on health care goods and services, but spent less than the other groups on prescription drugs and dental care-services not covered by Medicare. CONCLUSIONS: While Medicaid provides substantial protection for some lower-income Medicare beneficiaries, out-of-pocket health care spending continues to be a substantial burden for most of this population. Medicare reform discussions that focus on shifting more costs to beneficiaries should take into account the dramatic costs of health care already faced by this vulnerable population.

Aged↗

PubMed2005

The long road to patient safety: a status report on patient safety systems.

CONTEXT: Since the Institute of Medicine (IOM) reports on medical errors and quality, national attention has focused on improving patient safety through changes in "systems" of care. These reports resulted in a new paradigm that, rather than centering on individual errors, focuses on the "systems" necessary to facilitate and enhance quality and protect patients. OBJECTIVES: To assess the status of hospital patient safety systems since the release of the IOM reports and to identify changes over time in 2 states that collaborated on a patient safety project funded by the Agency for Healthcare Research and Quality. DESIGN, SETTING, AND PARTICIPANTS: Survey of all acute care hospitals in Missouri and Utah at 2 points in time, in 2002 and 2004, using a 91-item comprehensive questionnaire (n = 126 for survey 1 and n = 128 for survey 2). To assess changes over time, we also studied the cohort of 107 hospitals that responded to both surveys. MAIN OUTCOME MEASURES: Responses to the 91-question survey as well as changes in responses to the survey questions over an 18-month period. Seven latent variables were constructed to represent the most important patient safety constructs studied: computerized physician order entry systems, computerized test results, and assessments of adverse events; specific patient safety policies; use of data in patient safety programs; drug storage, administration, and safety procedures; manner of handling adverse event/error reporting; prevention policies; and root cause analysis. For each hospital, the 7 latent variables were summed to give an overall measure of the patient safety status of the hospital. RESULTS: Development and implementation of patient safety systems is at best modest. Self-reported regression in patient safety systems was also found. While 74% of hospitals reported full implementation of a written patient safety plan, nearly 9% reported no plan. The area of surgery appears to have the greatest level of patient safety systems. Other areas, such as medications, with a long history of efforts in patient safety and error prevention, showed improvements, but the percentage of hospitals with various safety systems was already high at baseline for many systems. Some findings are surprising, given the overall trends; for example, while a substantial percentage of hospitals have medication safety systems, only 34.1% [corrected] reported full implementation at survey 2 of computerized physician order entry systems for medications, despite the growth of computer technology in general and in hospital billing systems in particular. CONCLUSIONS: The current status of hospital patient safety systems is not close to meeting IOM recommendations. Data are consistent with recent reports that patient safety system progress is slow and is a cause for great concern. Efforts for improvement must be accelerated.

Hospital Administration↗