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Kevin T Kavanagh,1 Raeford E Brown Jr,2 Steve S Kraman,3 Lindsay E Calderon,4 Sean P Kavanagh51Health Watch USA, Somerset, KY, USA; 2Department of Anesthesiology, University of Kentucky Medical Center/Kentucky Children’s Hospital, Lexington, KY, USA; 3Department of Internal Medicine, University of Kentucky College of Medicine, Health Watch USA, Lexington, KY, USA; 4Department of Biological Sciences, Eastern Kentucky University, Health Watch USA, Lexingtion, KY, USA; 5Health Watch USA, Solon, OH, USAIntroduction: A review of the medical device adverse events submitted to the United States Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was undertaken to determine the major sources of the information.Methods: The reporter’s occupation and source of the medical device report were determined for acquisition dates Jan 1, 1997 to Dec 31, 2018. A total of 7,766,737 adverse event records were analyzed.Results: 96.6% of reports originated with the manufacturer. Patients (patients/family/friend) were the most frequent submitter of reports directly to the FDA, almost five times as often as physicians. Nurses submitted reports directly to the FDA 2.77 times as often as physicians. Only 0.49% of physician reports were submitted directly to the FDA, representing 0.09% of total MAUDE reports.Conclusion: Increasing physician reporting directly to the FDA and MAUDE through the MedWatch reporting system is an imperative. Incorporating information from the perspective of the physician has the potential of increasing the quality of the data and improving the reliability of post-market surveillance.Keywords: FDA, MAUDE, reporter, occupation, medical device, adverse events

The United States needs a paradigm shift in its approach to control infectious diseases. Current recommendations are often made in a siloed feedback loop. This may be the driver for such actions as the abandonment of contact precautions in some settings, the allowance of nursing home residents who are carriers of known pathogens to mingle with others in their facility, and the determination of an intervention's feasibility based upon budgetary rather than health considerations for patients and staff. Data from both the U.S. Veterans Health Administration and the U.K.'s National Health Service support the importance of carrier identification and source control. Both organizations observed marked decreases in methicillin-resistant Staphylococcus aureus (MRSA), but not methicillin-susceptible Staphylococcus aureus infections with the implementation of MRSA admission screening measures. Facilities are becoming over-reliant on horizontal prevention strategies, such as hand hygiene and chlorhexidine bathing. Hand hygiene is an essential practice, but the goal should be to minimize the risk of workers' hands becoming contaminated with defined pathogens, and there are conflicting data on the efficacy of chlorhexidine bathing in non-ICU settings. Preemptive identification of dedicated pathogens and effective source control are needed. We propose that the Centers for Disease Control and Prevention should gather and publicly report the community incidence of dedicated pathogens. This will enable proactive rather than reactive strategies. In the future, determination of a patient's microbiome may become standard, but until then we propose that we should have knowledge of the main pathogens that they are carrying., Competing Interests: None of the authors have any conflict of interests to declare. The lead author Dr. Kevin Kavanagh is a retired physician and Board Chairman of Health Watch USA and Lindsay Calderon donates her time to Health Watch USA. Dr. Mathesis is a Board Member of Health Watch USA and have no funding and conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Abstract: Currently, the healthcare workplace is one of the most dangerous in the United States. Over a 3-month period in 2022, two nurses were assaulted every hour. Artificial intelligence (AI) has the potential to prevent workplace violence by developing unique patient insights through accessing almost instantly a patient's medical history, past institutional encounters, and possibly even their social media posts. De-escalating dialog can then be formulated, and hot-button topics avoided. AIs can also monitor patients in waiting areas for potential confrontational behavior.Many have concerns implementing AIs in healthcare. AIs are not expected to be 100% accurate, their performance is not compared with a computer but instead measured against humans. However, AIs are outperforming humans in many tasks. They are especially adept at taking standardized examinations, such as Board Exams, the Uniform Bar Exam, and the SAT and Graduate Record Exam. AIs are also performing diagnosis. Initial reports found that newer models have been observed to equal or outperform physicians in diagnostic accuracy and in the conveyance of empathy.In the area of interdiction, AI robots can both navigate and monitor for confrontational and illegal behavior. A human security agent would then be notified to resolve the situation. Our military is fielding autonomous AI robots to counter potential adversaries. For many, this new arms race has grave implications because of the potential of fielding this same security technology in healthcare and other civil settings.The healthcare delivery sector must determine the future roles of AI in relationship to human workers. AIs should only be used to support a human employee. AIs should not be the primary caregiver and a single human should not be monitoring multiple AIs simultaneously. Similar to not being copyrightable, disinformation produced by AIs should not be afforded 'free speech' protections. Any increase in productivity of an AI will equate with a loss of jobs. We need to ask, If all business sectors utilize AIs, will there be enough paid workers for the purchasing of services and products to keep our economy and society a float?, Competing Interests: Competing Interests: Conflicts of Interest: KTK has investments in several AI and robotic companies including Microsoft, Amazon, and Hyundai and was the keynote speaker regarding AI before the Massachusetts Nurses Association. KTK is an Associate Editor of the Journal of Patient Safety and on the Editorial Board of Infection Control Today. The other authors have no other competing interests., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

The incidence of long COVID in adult survivors of an acute SARS-CoV-2 infection is approximately 11%. Of those afflicted, 26% have difficulty with day-to-day activities. The majority of long COIVD cases occur after mild or asymptomatic acute infection. Children can spread SARS-CoV-2 infections and can also develop long-term neurological, endocrine (type I diabetes), and immunological sequelae. Immunological hypofunction is exemplified by the recent large outbreaks of respiratory syncytial virus and streptococcal infections. Neurological manifestations are associated with anatomical brain damage demonstrated on brain scans and autopsy studies. The prefrontal cortex is particularly susceptible. Common symptoms include brain fog, memory loss, executive dysfunction, and personality changes. The impact on society has been profound. Fewer than half of previously employed adults who develop long COVID are working full-time, and 42% of patients reported food insecurity and 20% reported difficulties paying rent. Vaccination not only helps prevent severe COVID-19, but numerous studies have found beneficial effects in preventing and mitigating long COVID. There is also evidence that vaccination after an acute infection can lessen the symptoms of long COVID. Physical and occupational therapy can also help patients regain function, but the approach must be "low and slow." Too much physical or mental activity can result in post-exertional malaise and set back the recovery process by days or weeks. The complexity of long COVID presentations coupled with rampant organized disinformation, have caused significant segments of the public to ignore sound public health advice. Further research is needed regarding treatment and effective public communication., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Promoting and maintaining patient safety in primary care requires different strategies and monitoring than utilized in large healthcare delivery systems. Maintenance of a culture of safety is key to providing patient safety but has been difficult to measure in primary care. This is particularly true in rural settings where practice size is a major barrier to measurement reliability. Primary care evaluates a wide range of patients, including those who are immunocompromised and others who have infectious diseases. Providing a safe environment with proper wearing of N95 masks, clean examination rooms, and adequate ventilation is important. Patients with infectious diseases should be separated from other patient populations. Primary care is often less bureaucratic than hospitals, but also has fewer resources to implement patient safety initiatives, along with detecting safety lapses and adverse events. However, monitoring the practice's safety practices and the culture of safety is of utmost importance and should be performed using both outcome and process measures. Because of the small size of many rural practices, effective monitoring of adverse events and maintenance of safety protocols should include patients. Patients are an important resource for reporting of adverse events and medical treatment outcomes. The aim of this manuscript is to underscore the importance of patient safety in primary care and to stimulate future research in developing a metric for the culture of safety in primary care, which also incorporates the patient perspective. Patients should be viewed not only as beneficiaries of patient safety but also as a critical component of its maintenance., (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

The third annual Health Watch USA sm webinar conference assembled 16 speakers from 4 continents who shared information regarding frontline worker safety in the age of COVID-19. The U.S. Bureau of Labor Statistics reported a nearly 4000% increase in workplace illness in 2020 compared with 2019. It is estimated that 2% of the U.S. workforce is not working because of long COVID. In addition, the impact is growing with each surge. After the acute illness, patients are often described as recovered, when in fact many have only survived and are coping with the multisystem impacts of long COVID. Long COVID, including its late cognitive, cardiovascular, embolic, and diabetic complications, disproportionately impacts frontline workers, many of whom are of lower socioeconomic status and represented by ethnic minorities. Natural infection and current vaccines do not provide durable protection for reinfection. Herd immunity is not possible at this time. Although SARS-CoV-2 is unlikely to be eliminated, decreasing spread is imperative to slow the rate of mutations, decrease the number of reinfections, and lower the chances of developing long COVID. The primary mode of spread is through aerosolization. Both routine breathing and talking aerosolizes the virus. With the extremely high infectivity of SARS-CoV-2, it is unlikely that central building ventilation alone will be enough to satisfactorily mitigate spread. Additional safe active air cleaning technology, such as upper-room germicidal UV-C lighting, needs to be deployed. Misinformation and disinformation have inhibited response effectiveness. Examples include downplaying the benefit of well-fitted masks and the risks that COVID-19 and long COVID pose to children, along with believing children cannot spread the disease. The engagement of local community leaders is essential to educate the community and drive social change to accept vaccinations and other public health interventions. Vaccinations and natural immunity alone are unlikely to adequately prevent community spread and do not provide durable protection against the risk of long COVID. Frontline workers must keep their immunity as high as possible and work in settings with clean air, along with wearing N95 masks when they are in contact with the public. Finally, there needs to be a financial safety net for frontline workers and their families in the event of incapacitation or death from COVID-19., Competing Interests: K.T.K. is an associate editor of the Journal of Patient Safety and on the editorial board of Infection Control Today . The other authors disclose no conflict of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

One June 15, 2021, infectious disease authorities from around the world participated in a joint webinar to share experiences and lessons learned in combatting the COVID-19 pandemic. One of the overriding goals of the conference "COVID-19 Lessons Learned: A Global Perspective" was to provide documentation of worldwide COVID-19 response strategies, in order to combat the plethora of misinformation and conspiracy theories that are being actively disseminated. This misinformation is having a profound negative impact on controlling the pandemic in many countries. Misinformation which was addressed in the conference included challenging the seriousness of COVID-19 infections, a refusal to recognize aerosolization as the major mechanism of spread, a belief that schools can be opened safely without implementation of extensive control strategies, and that masks and vaccines are not effective. A second goal was the identification of common strategies between nations.  Common strategies included the implementation of a range of closures, mask mandates, travel bans and the need for expanded testing. But of utmost importance there was recognition of the need to implement a coordinated national strategy, which is depoliticized and led by scientists., (© 2021. The Author(s).)

COVID-19 is continuing to ravage the globe. In many Western Countries, the populous has not embraced public health advice which has resulted in a resurgence of the COVID-19 virus. In the United States, there is an absence of a coordinated Federal response. Instead, frontline workers and average citizens are having to cope with extensive mixed messaging regarding mask usage and social distancing from the highest levels of government. This has resulted in the United States not being able to achieve a low level of infection since the pandemic began. In addition, many citizens hold a profound belief that individual freedoms must be preserved, even at the expense of public health; and view the wearing of masks as renouncing this right. These engrained political beliefs can be traced back to the late 1800s. The response of the United States has also been hampered by a highly cost-efficient healthcare system, which does not provide universal care and has a just-in-time supply chain, with far too few supplies in reserve. This efficiency prevented a rapid scaling up of the healthcare response, which resulted in severe deficiencies in available personal protective equipment (PPE) and healthcare staff. To compound issues many healthcare staff are not provided an economic or healthcare safety net. Other frontline workers, such as those who work in transportation and food services, are working under even greater adversities. Many of these workers are from diverse backgrounds, who, along with their families, are at even greater risk for COVID-19. This vulnerable population of frontline workers are faced with a choice of going to work with inadequate PPE or placing food on their families' table. In the United States, official recommendations seem to be ever changing, based more upon supply and test availability, than on science. We must rely on science and learn from the lessons of past pandemics or we will relive, even to a greater degree, the deaths and devastations experienced by our ancestors over 100 years ago.

Data released by the U.S. Centers for Disease Control and Prevention (CDC) on March 5, 2019 showed that Staph aureus infections are a major problem in the United States, with 119,000 infections and almost 20,000 deaths in 2017. Rates of decline for hospital-onset MRSA have slowed since 2012 and the United States is not on track for meeting the 2015 U.S. Dept. of Health and Human Services' goal of a 50% reduction by 2020. There is a need for improved standards for control of dangerous pathogens. Currently, the World Health Organization's recommendation of preoperatively screening patients for Staph aureus  has not become a standard of care in the United States. The U.S. Veterans Health Administration also released data which found a much larger decrease in hospital-onset MRSA infections as opposed to hospital-onset MSSA using various infectious disease bundles that all included universal MRSA surveillance and isolation for MRSA carriers. These results mirror the results obtained by the United Kingdom's National Health Service. These findings support the contention that the marked decline in hospital-onset MRSA infections observed in these studies is due to interventions which are specifically targeted towards MRSA. A case is made that concerns with the integrity of healthcare policy research, along with industrial conflicts-of-interest have inhibited effective formulation of infectious disease policy in the United States. Because MRSA has become endemic in the general U.S. population (approximately 2%), the author advocates that universal facility-wide screening of MRSA on admission be included in infection prevention bundles used at U.S. hospital., Competing Interests: Competing interestsDr. Kevin Kavanagh has received partial conference attendance and meeting support from the U.S. Dept. of Health and Human Services, National Quality Forum, National Patient Safety Foundation (NPSF), The Leapfrog Group, National Quality Forum, Consumer Union and the Anesthesia Patient Safety Foundation. He has served on the Centers for Medicare and Medicaid Services’ Technical Expert Panel for Hospital Acquired Conditions, and most recently on the Strategic Working Group for AHRQ for quality indicators, and AHRQ Health Care Effectiveness and Outcomes Research (HEOR) Study Section. He is an Associate Editor for the Journal of Patient Safety for which he receives an honorarium. He has a first degree relative, who is employed by a state university, and is involved with the development of cancer chemotherapeutic and diagnostic agents.

Introduction: This study was designed to determine whether systemic cobalt toxicity as an adverse event could be documented using the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for cobalt-chromium containing hip implant recipients. Class 3 Johnson & Johnson (J&J)/DePuy devices were chosen for analysis because of the large number of adverse event reports related to their Pinnacle and ASR XL Acetabular hip replacement systems. A secondary goal was to characterize the reporters who are populating the information in the MAUDE database and to evaluate the quality of the data and information submitted., Methods: Using FDA MAUDE downloadable data files, 83,528 adverse event medical device narrative reports were identified with the product code of KWA (Prosthesis, Hip, Semiconstrained [Metal Uncemented Acetabular Component]) for J&J/DePuy (KWA Text File). These are class 3 devices and devices with known high failure rates. The ASR XL Acetabular hip replacement Systems and Pinnacle fall into this category. This group of implants was chosen because implant failure is associated with elevated cobalt levels. Two additional subfiles were created from Free Text records in the narrative reports containing key words that indicated a chromium or cobalt (CrCo) device and another for key words indicating elevated levels of cobalt or toxicity. These files were then searched for symptoms of systemic cobalt toxicity with Microsoft Excel using key words pertaining to symptom categories of: cognitive/memory loss, tremor, neuropathy, depression, auditory symptoms, visual symptoms, cardiac, and thyroid disease. Reports are submitted to the FDA at the device component level. It was common for multiple reports to be submitted for a single device., Results: It was not possible to differentiate systemic versus local symptoms for adverse event reports in the neuropathy category. This category was not analyzed. The number of adverse event reports in the other categories ranged from 119 to 16 for the J&J/DePuy KWA Text File and 59 to 4 in the file of records having key words indicating potential elevation of CrCo or toxicity. Cardiac, visual, and auditory conditions were most frequently reported. With the possible exception of cardiomyopathy, the numbers of these reports are far below the prevalence expected in the general population of comparable age. The content of the MAUDE database records often contained little objective data. We found less than 4% of 14,714 records, which indicated cobalt elevation or toxicity contained units for quantitative measurement. There was also frequent use of nondescript, all-encompassing words and phrases such as "mental anguish," found in 321 KWA Text File records. Manufacturers submitted more than 99% of the reports and the most common reporter occupation was attorney, found in 42.24% of the 83,550 J&J/DePuy KWA Reporter File records. Physician was the reporter's occupation in 20.48% of reports but seldom reported directly to the FDA., Conclusions: We were not able find in the FDA MAUDE database meaningful warning signs to support the contention that chromium-cobalt-containing Class 3 J&J and DePuy hip implants caused systemic neurological or thyroid symptoms in patients. The incidence of reported cardiomyopathy was rare but frequent enough to be cause of concern. The redaction of most patient data along with the nonstructured nature of data entry would be expected to hinder the identification of warning signs. Even identification of the type of device could not be consistently carried out. In addition, the FDA needs to implement a methodology to identify and group all reports from a single device implanted into a patient, so duplication of event counting would not occur. Of 83,550 J&J/DePuy KWA Reporter File records, we found only two physician reports sent directly to the FDA. Almost all reports are submitted by manufacturers and are most commonly authored by attorneys. A standard of care needs to be set for physicians to report medical device adverse events to the FDA.

A review of epidemiological studies on the incidence of MRSA infections overtime was performed along with an analysis of data available for download from Hospital Compare (https://data.medicare.gov/data/hospital-compare). We found the estimations of the incidence of MRSA infections varied widely depending upon the type of population studied, the types of infections captured and in the definitions and terminology used to describe the results. We could not find definitive evidence that the incidence of MRSA infections in U.S. community or facilities is decreasing significantly. Of concern are recent data reported to the National Healthcare Safety Network (NHSN) on MRSA bloodstream infections which indicate that by the end of 2015 there had been little change in the average facility Standardized Infection Ratio (0.988), compared to a 2010-2011 baseline and is significantly increased compared to the previous year. This is in contradistinction to the recent Veterans Administration study which reported over an 80% reduction in MRSA infections. However, this discrepancy may be due to the inability to reconcile the baselines of the two data sets; and the observed increase may be artifactual due to aberrations in the NHSN tracking system. Our review supports the need for implementation of a comprehensive tracking and monitoring system involving all types of healthcare facilities for multi-drug resistant organisms, along with concomitant funding for both staff and infrastructure. Without such a system, determining the effectiveness of interventions such as antibiotic stewardship and chlorhexidine bathing will be hindered.

The authors present a viewpoint regarding the quality of data used in estimating the number of preventable hospital deaths in the United States. Data derived from countries with a nationalized healthcare system with well-defined and near uniform implementation of standards may not be applicable to the fragmented noncentralized delivery system found in the United States. Although U.S. studies evaluating preventable mortality have based their projections on a small sample size, it is unlikely that this observation is due to chance, because other studies evaluating adverse events, a precursor to preventable mortality, have a much larger sample size and also report an unacceptably high number of events. In addition, although these estimates involved adult and Medicare-eligible patients who may have a higher incidence of events and create a bias, but they also did not capture all events, taken into account of mortality, which occurs after hospitalization or from misdiagnoses. It is also important not to mitigate adverse events in patients whose death is imminent. Medicine does not have the moral authority to place differing values on days, weeks, or years of life. The contention that there are approximately 200,000 preventable hospital-related deaths each year in the United States is not unreasonable. Not all hospital systems in the United States make the same investment in patient safety. Recently, the Agency for Healthcare Research & Quality has demonstrated a decline in adverse events in hospitals, but until uniform implementation of safety standards takes place, our healthcare system as a whole may well lag behind other industrialized nations.

The medical literature is prone to overstating results, a condition not thoroughly recognized among policymakers. This article sets forth examples of potential problems with research integrity in the infectious disease literature. We describe articles that may be spun, categories lumped together in hopes of creating a significant effect (and sometimes an insignificant one), changes in metrics, and how trials may fail because of suboptimal interventions. When examined together, the examples show that the problems are widespread and illustrate the difficulty associated with interpreting medical research. The state of the current medical literature makes it of utmost importance that all sections of the manuscript are read, including associated letters to the editors and information on ClinicalTrials.gov before authors' recommendations are accepted.

In this study the authors investigate the sound pressure levels produced by crying children and discuss the possible adverse effects that direct exposure may impose on a tending guardian or healthcare professional. Sound intensity levels from various pediatric patients (N = 26) were measured under two segregate conditions, one imitating the exposure of an examining physician and the other resembling that of parental guardians. Interestingly, all of the recorded sound levels fell between 99-120 dB(A) of sound pressure; children presenting the greatest risk for intense cries with potentially harmful sound intensities were between the ages of 9 months and 6 years. The authors found that elevated noise levels produced from crying children can cause acute discomfort and mild pain to those exposed. In addition, there is a theoretical risk that chronic exposure to these intense sound pressures may result in noise-induced hearing loss in a parental guardian or an examining physician. Parents of young children may be more likely to succumb to impulsive reactions in attempting to arrest the crying, which could be a precipitating factor for child abuse, responding to physical stress as much as emotional stress. Social workers and medical personnel should consider suggesting the use of ear plugs by parental guardians of frequently crying children as a modality for the prevention of child abuse.

Catheter-associated urinary tract infections (CAUTIs) occur in 290,000 US hospital patients annually, with an estimated cost of $290 million. Two different measurement systems are being used to track the US health care system's performance in lowering the rate of CAUTIs. Since 2010, the Agency for Healthcare Research and Quality (AHRQ) metric has shown a 28.2% decrease in CAUTI, whereas the Centers for Disease Control and Prevention metric has shown a 3%-6% increase in CAUTI since 2009. Differences in data acquisition and the definition of the denominator may explain this discrepancy. The AHRQ metric analyzes chart-audited data and reflects both catheter use and care. The Centers for Disease Control and Prevention metric analyzes self-reported data and primarily reflects catheter care. Because analysis of the AHRQ metric showed a progressive change in performance over time and the scientific literature supports the importance of catheter use in the prevention of CAUTI, it is suggested that risk-adjusted catheter-use data be incorporated into metrics that are used for determining facility performance and for value-based purchasing initiatives., (Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)

Surveillance and isolation for the prevention of methicillin-resistant Staphylococcus aureus (MRSA) has become a controversial topic, one that causes heated debate and appears to be surrounded by both politics and industrial conflicts-of-interest. There have been calls from numerous authors for a movement away from rigid mandates and toward an evidence-based medicine approach. However, much of the evidence can be viewed with an entirely different interpretation. Two major studies with negative findings have had an adverse impact on recommendations regarding active detection and isolation (ADI) for MRSA. However the negative findings in these studies can be explained by shortcomings in study implementation rather than the ineffectiveness of ADI. The use of daily chlorhexidine bathing has also been proposed as an alternative to ADI in ICU settings. There are shortcomings regarding the evidence in the literature concerning the effectiveness of daily chlorhexidine bathing. One of the major concerns with universal daily chlorhexidine bathing is the development of bacterial resistance. The use of surveillance and isolation to address epidemics and common dangerous pathogens should solely depend upon surveillance and isolation's ability to prevent further spread to and infection of other patients through indirect contact. At present, there is a preponderance of evidence in the literature to support continuing use of surveillance and isolation to prevent the spread of MRSA.

Introduction: The hidden cost of defensive medicine has been cited by policymakers as a significant driving force in the increase of our nation's health-care costs. If this hypothesis is correct, one would expect that states with higher levels of tort reform will have a decrease in Medicare utilization and that medical utilization will decrease after tort reform is enacted., Methods: State-level reimbursement data for years 1999 to 2010 (the last year available) was obtained from the Dartmouth Atlas of Health Care. Medical tort rankings for the 50 states were obtained from the Pacific Research Institute (PRI) and correlated with state medical utilization for the year 2010. In 3 states, Mississippi, Nevada, and Texas, data were available to make pretort and posttort reform comparisons., Results: Data analysis between total state Medicare Reimbursements and the PRI's tort rankings showed no significant observed correlation. In 6 Medicare utilization categories (total Medicare, hospital and skilled nursing facility, physician, home health agency, hospice, and durable medical equipment), a negative trend was observed when correlated with PRI tort rankings. This trend does not support the hypothesis that defensive medicine is a major driver of health-care expenditures. Tracking expenditures in the states of Texas, Nevada, and Mississippi, before and after passage of comprehensive medical tort reform gave inconsistent results and did not demonstrate substantial or meaningful total Medicare savings. In Mississippi, there was a trend of decreased expenditures after medical tort reform was passed. However, in Texas, where 80% of the analyzed enrollees resided, there was a trend of progressive increasing expenditures after tort reform was passed., Conclusion: The comparison of the Dartmouth Atlas Medicare Reimbursement Data with Malpractice Reform State Rankings, which are used by the PRI, did not support the hypothesis that defensive medicine is a driver of rising health-care costs. Additionally, comparing Medicare reimbursements, premedical and postmedical tort reform, we found no consistent effect on health-care expenditures. Together, these data indicate that medical tort reform seems to have little to no effect on overall Medicare cost savings.

The Agency for Healthcare Research & Quality (AHRQ) found that Methicillin-resistant Staphylococcus aureus (MRSA) is associated with up to 375,000 infections and 23,000 deaths in the United States. It is a major cause of surgical site infections, with a higher mortality and longer duration of care than Methicillin-sensitive Staphylococcus aureus. A multifactorial bundled approach is needed to control this epidemic, with single interventions unlikely to have a significant impact on attenuating MRSA infection rates. Active surveillance has been studied in a wide range of surgical patients, including surgical intensive care and non-intensive care units; cardiac, vascular, orthopedic, obstetric, head and neck cancer and gastrostomy patients. There is sufficient evidence demonstrating a beneficial effect of surveillance and eradication prior to surgery to recommend its use on an expanded basis. Studies on MRSA surveillance in surgical patients that were published over the last 10 years were reviewed. In at least five of these studies, the MRSA colonization status of patients was reported to be a factor in preoperative antibiotic selection, with the modification of treatment regiments including the switching to vancomycin or teicoplanin in MRSA positive preoperative patients. Several authors also used decolonization protocols on all preoperative patients but used surveillance to determine the duration of the decolonization. Universal decolonization of all patients, regardless of MRSA status has been advocated as an alternative prevention protocol in which surveillance is not utilized. Concern exists regarding antimicrobial stewardship. The daily and universal use of intranasal antibiotics and/or antiseptic washes may encourage the promotion of bacterial resistance and provide a competitive advantage to other more lethal organisms. Decolonization protocols which indiscriminately neutralize all bacteria may not be the best approach. If a patient's microbiome is markedly challenged with antimicrobials, rebuilding it with replacement commensal bacteria may become a future therapy. Preoperative MRSA surveillance allows the selection of appropriate prophylactic antibiotics, the use of extended decolonization protocols in positive patients, and provides needed data for epidemiological studies.

This brief article presents results that support the contention that risk adjustment via the standardized infection ratio (SIR) for the reporting of central line-associated bloodstream infections (CLABSIs) may be no more predictive than standard rate adjustments utilizing CLABSIs per central line days (i.e., CLABSI rates). Recent data posted on the U.S. Department of Health and Human Services' Hospital Compare website showed that nearly 70% of 1721 reporting hospitals with at least 1000 central line days had five or fewer infections during 2011. These hospitals had 39.3% of the total central line days and a significantly lower SIR than poorer performing hospitals with six or more CLABSIs (p<0.0001). In addition, 19 hospitals are presented which had central line days between 9000 to over 22,000 that also had zero to three CLABSIs. Some of these hospitals were university referral centers and inner city facilities. There was great variation of CLABSI cases among US hospitals. Evidence is mounting that all hospitals should be able to achieve a near zero incidence of CLABSIs and that these infections may in fact be near 'never events', which begs whether risk adjustment with the SIR is needed and whether it adds more information than does rate adjustment using CLABSI rates.

The derivations of the standardized infection ratio (SIR) are reviewed in this report. To be most understandable to the consumer, the SIR National Benchmark of 1.0 should reflect what is obtainable.The SIR is a tool intended to be used by consumers in value purchasing to compare differences between facilities and thus should not adjust for these differences. Ideally, factors used in risk adjustment should solely be based upon patient characteristics. Thus, facility-specific adjustments (i.e., medical school affiliation, major teaching institution and unit bed size) should be used with caution in calculating the SIR and their use made clearly transparent to health-care consumers.Using data downloaded from the US Department of Health and Human Services' website, Hospital Compare, we observed an average SIR for central line blood stream infections of 0.568 and an SIR at the peak of the distribution curve approximating 0.35. A suggested methodology to calculate an obtainable SIR is to set the National Benchmark of 1.0 at the location of the distribution curve's peak. The curve's peak is more reflective of higher performing facilities. The SIR needs to reflect the expected performance of facilities, which are using up-to-date methods of infection control. The remainder of the facility SIRs can then be adjusted accordingly.It is recommended that the obtainable SIR be calculated every other year using data from the most recent 3 years. This enables the SIR to be reset as the control of health care-associated infections progressively improves.

Background: Factors that increase the risk of central line-associated bloodstream infections (CLABSIs) are not fully understood. Recently, Hospital Compare began compiling data from hospital-required reporting to the CDC's National Healthcare Safety Network on CLABSIs in intensive care units (ICUs), at over 4,000 Medicare-certified hospitals in the United States, and made this data accessible on a central website. Also available on the same website are results from the Hospital Consumer Assessment of Healthcare Providers and Systems survey of patients' hospital experiences. Utilizing both databases, our objective was to determine whether patients' hospital experiences were significantly associated with increased risk for reported ICU CLABSI., Methods and Findings: We conducted a zero-inflated Poisson regression analysis at the hospital level on CLABSI-observed cases by ICUs in acute care hospitals (n = 1987) in the United States between January 1, 2011, and December 31, 2011. During this period there were a total of 10,866 CLABSI cases and 9,543,765 central line days. In our final model, the percent of patients who reported that they "sometimes" or "never" received help as soon as they wanted was significantly associated with an increased risk for CLABSIs., Conclusions: Using national datasets, we found that inpatients' hospital experiences were significantly associated with an increased risk of ICU reported CLABSIs. This study suggests that hospitals with lower staff responsiveness, perhaps because of an understaffing of nurse and supportive personnel, are at an increased risk for CLABSIs. This study bolsters the evidence that patient surveys may be a useful surrogate to predicting the incidence of hospital acquired conditions, including CLABSIs. Moreover, our study found that poor staff responsiveness may be indicative of greater hospital problems and generally poorly performing hospitals; and that this finding may be a symptom of hospitals with a multitude of problems, including patient safety problems, and not a direct cause.

Purpose: To underscore the need for health system reform and emphasize nursing measures as a key component in our healthcare reimbursement system., Design and Methods: Nursing-sensitive value-based purchasing (NSVBP) has been proposed as an initiative that would help to promote optimal staffing and practice environment through financial rewards and transparency of structure, process, and patient outcome measures. This article reviews the medical, governmental, institutional, and lay literature regarding the necessity for, method of implementation of, and potential impact of NSVBP., Findings: Research has shown that adverse events and mortality are highly dependent on nurse staffing levels and skill mix. The National Database of Nursing Quality Indicators (NDNQI), along with other well-developed indicators, can be used as nursing-sensitive measurements for value-based purchasing initiatives. Nursing-sensitive measures are an important component of value-based purchasing., Conclusions: Value-based purchasing is in its infancy. Devising an effective system that recognizes and incorporates nursing measures will facilitate the success of this initiative. NSVBP needs to be designed and incentivized to decrease adverse events, hospital stays, and readmission rates, thereby decreasing societal healthcare costs., Clinical Relevance: NSVBP has the potential for improving the quality of nursing care by financially motivating hospitals to have an optimal nurse practice environment capable of producing optimal patient outcomes by aligning cost effectiveness for hospitals to that of the patient and society., (© 2012 Sigma Theta Tau International.)

Over a decade ago it was estimated that in the United States 98,000 patients die each year from hospital acquired conditions (HAC). Recently it has been reported that this many patients now die annually from hospital acquired infections (HAI) alone. Currently, HAI affects 1.7 million U.S. citizens each year. Although these conditions are often called "preventable errors," some are associated with particular hospital and physician cultures, and many of these conditions, such as pressure ulcer formation and infections, may be a sign of low facility staffing levels. Protocols have been developed that have been shown to lower the incidence of many HAC, but these have been slow to be adopted. Voluntary reporting mechanisms to ensure health care quality are reported as having reduced effectiveness by the Joint Commission and U.S. Department of Health and Human Services, Office of Inspector General reports. Transparency and public education have also met with resistance, but in the case of infections now have the support of major national medical organizations. As a further initiative to promote quality, financial incentives have been implemented by the Centers for Medicare and Medicaid Services. Surgeons have lived under stringent financial incentives since the mid-1980s when they were placed under global surgical fees. Medicare currently must make expenditure reductions because it is at risk of becoming insolvent within the decade. Implementation of financial incentives should depend upon a balance between the nonpayment of providers for nonpreventable HAC verses the promotion of health care quality and patient safety, the reduction in patient morbidity and mortality, the spurring of mechanisms to further reduce HAC, and the recouping of taxpayer dollars for HAC that could have been prevented.

Classical NF-kappaB (p65/p50) transcription factors display dynamic induction in the mammary gland during pregnancy. To further elucidate the role of NF-kappaB factors in breast development, we generated a transgenic mouse expressing the IkappaB-alpha S32/36A superrepressor (SR) protein under control of the mouse mammary tumor virus (MMTV) long terminal repeat promoter. A transient delay in mammary ductal branching was observed in MMTV-SR-IkappaB-alpha mice early during pregnancy at day 5.5 (d5.5) and d7.5; however, development recovered by mid- to late pregnancy (d14.5). Recovery correlated with induction of nuclear cyclin D1 and RelB/p52 NF-kappaB complexes. RelB/p52 complexes induced cyclin D1 and c-myc promoter activities and failed in electrophoretic mobility shift assay to interact with IkappaB-alpha-glutathione S-transferase, indicating that their weak interaction with IkappaB-alpha can account for the observed recovery of mammary gland development. Activation of IKKalpha and NF-kappaB-inducing kinase was detected by d5.5, implicating the alternative NF-kappaB signaling pathway in RelB/p52 induction. Constitutively active IKKalpha induced p52, RelB, and cyclin D1 in untransformed mammary epithelial cells. Moreover, mouse mammary tumors induced by 7,12-dimethylbenz(a)anthracene treatment displayed increased RelB/p52 activity. Inhibition of RelB in breast cancer cells repressed cyclin D1 and c-Myc levels and growth in soft agar. These results implicate RelB/p52 complexes in mammary gland development and carcinogenesis.

Ninety-eight percent of 51 polled medical editors felt that published research articles should be available to the public on the World Wide Web at no charge, after a mean time from publication of 1.4 years for viewing and 1.9 years for printing. Public libraries or other government institutions could be allowed to assume the responsibility of housing and distributing the electronically stored archived material, analogous to their role with printed material, lifting the financial burden from the publishing companies.

The study goal was to post a complete set of temporal bone anatomy slides on the World Wide Web for anatomic study. Magnification of the width of the sections varied from 2.4 to 33.6 inches. Good representation of gross and tissue anatomy was obtained, but cellular detail was lacking. The website used approximately 37 megs of disk space. The resultant website provides a cost-effective method of presenting large color photographs of temporal bone anatomy. Thumbnails allow comparison between sections, which aids in learning 3-dimensional anatomy. A method for measuring distance on digitized images is also described. The sections may be viewed at www.ear-anatomy.com, and continuing medical education credits may be earned at www.cme-usa.org.

Overexpression of the epidermal growth factor receptor family member Her-2/neu in breast cancer is associated with poor prognosis. With evidence accumulating for a chemopreventive role of green tea polyphenols, the effects of epigallocatechin-3 gallate (EGCG) on Her-2/neu-overexpressing breast cancer cells were examined. EGCG inhibited mouse mammary tumor virus (MMTV)-Her-2/neu NF639 cell growth in culture and soft agar. EGCG reduced signaling via the phosphatidylinositol 3- kinase, Akt kinase to NF-kappaB pathway because of inhibition of basal Her-2/neu receptor tyrosine phosphorylation. EGCG similarly inhibited basal receptor phosphorylation in SMF and Ba/F3 2 + 4 cells, which suggests the potential beneficial use of EGCG in adjuvant therapy of tumors with Her-2/neu overexpression.

Epidemiological evidence suggests tea (Camellia sinensis L.) has chemopreventive effects against various tumors. Green tea contains many polyphenols, including epigallocatechin-3 gallate (EGCG), which possess anti-oxidant qualities. Reduction of chemically induced mammary gland carcinogenesis by green tea in a carcinogen-induced rat model has been suggested previously, but the results reported were not statistically significant. Here we have tested the effects of green tea on mammary tumorigenesis using the 7,12-dimethylbenz(a)anthracene (DMBA) Sprague-Dawley (S-D) rat model. We report that green tea significantly increased mean latency to first tumor, and reduced tumor burden and number of invasive tumors per tumor-bearing animal; although, it did not affect tumor number in the female rats. Furthermore, we show that proliferation and/or viability of cultured Hs578T and MDA-MB-231 estrogen receptor-negative breast cancer cell lines was reduced by EGCG treatment. Similar negative effects on proliferation were observed with the DMBA-transformed D3-1 cell line. Growth inhibition of Hs578T cells correlated with induction of p27(Kip1) cyclin-dependent kinase inhibitor (CKI) expression. Hs578T cells expressing elevated levels of p27(Kip1) protein due to stable ectopic expression displayed increased G1 arrest. Thus, green tea had significant chemopreventive effects on carcinogen-induced mammary tumorigenesis in female S-D rats. In culture, inhibition of human breast cancer cell proliferation by EGCG was mediated in part via induction of the p27(Kip1) CKI., (Copyright 2001 Wiley-Liss, Inc.)

Nuclear factor (NF)-kappaB/Rel transcription factors normally exist in non-B cells, such as epithelial cells, in inactive forms sequestered in the cytoplasm with specific inhibitory proteins, termed IkappaBs. Recently, however, we discovered that breast cancer is typified by aberrant constitutive expression of NF-kappaB/Rel factors. Because these factors control genes that regulate cell proliferation, here we analyzed the potential role of NF-kappaB/Rel in the ability of transforming growth factor (TGF)-beta1 to inhibit the growth of breast cancer cells. The decreased growth of Hs578T and MCF7 breast cancer cell lines on TGF-beta1 treatment correlated with a drop in NF-kappaB/Rel binding. This decrease was due to the stabilization of the inhibitory protein IKB-alpha. Ectopic expression of c-Rel in Hs578T cells led to the maintenance of NF-kappaB/Rel binding and resistance to TGF-beta1-mediated inhibition of proliferation. Similarly, expression of the p65 subunit ablated the inhibition of Hs578T cell growth mediated by TGF-beta1. Thus, the inhibition of the aberrantly activated, constitutive NF-kappaB/Rel plays an important role in the arrest of the proliferation of breast cancer cells, which suggests that NF-kappaB/Rel may be a useful target in the treatment of breast cancer.