Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

Children with acute leukemia: A comparison of outcomes and cost-effectiveness from allogeneic blood stem cell and bone marrow transplantation

The relative merits of PBSCT versus BMT for children with standard and high risk hematologic malignancies remain unclear. In a retrospective single center study, we compared allogeneic peripheral blood stem cell transplantation (PBSCT) (n=30) with bone marrow transplantation (BMT) (n=110) in children with acute leukemia. We studied recipients of HLA matched sibling stem cells, and of stem cells from alternative donors (HLA mismatched and/or unrelated) and determined whether sourcing the stem cells from PB or marrow affected engraftment, incidence of acute and chronic GvHD, and disease-free survival at 1 year. Our results show a modest reduction in time to engraftment from PB stem cells and no greater risk of GvHD, but illustrate that the severity of the underlying disease is by far the greatest determinant of 1 year survival. Patients in the BMT group had a higher treatment success rate and lower costs than the recipients of the PBSCT within the standard but not the high risk disease group, where the treatment success rate and the cumulative costs were lower in the PBSCT group compared to the BMT group. Our current incremental cost-effectiveness ratio and analysis of uncertainty suggest that allogeneic transplantation of bone marrow grafts was a more cost-effective treatment option compared to peripheral blood stem cells in patients with standard risk childhood acute leukemia disease. For high risk disease our data are less prescriptive, since the differences were more limited and the range of costs much larger. Neither option demonstrated a clear advantage from a cost-effectiveness standpoint.^

Bayesian inference and its application to meta-analysis of epidemiologic data

In Part One, the foundations of Bayesian inference are reviewed, and the technicalities of the Bayesian method are illustrated. Part Two applies the Bayesian meta-analysis program, the Confidence Profile Method (CPM), to clinical trial data and evaluates the merits of using Bayesian meta-analysis for overviews of clinical trials.^ The Bayesian method of meta-analysis produced similar results to the classical results because of the large sample size, along with the input of a non-preferential prior probability distribution. These results were anticipated through explanations in Part One of the mechanics of the Bayesian approach. ^

Second, do less harm: The state of states' medical error reporting programs

Statement of the problem and public health significance. Hospitals were designed to be a safe haven and respite from disease and illness. However, a large body of evidence points to preventable errors in hospitals as the eighth leading cause of death among Americans. Twelve percent of Americans, or over 33.8 million people, are hospitalized each year. This population represents a significant portion of at risk citizens exposed to hospital medical errors. Since the number of annual deaths due to hospital medical errors is estimated to exceed 44,000, the magnitude of this tragedy makes it a significant public health problem. ^ Specific aims. The specific aims of this study were threefold. First, this study aimed to analyze the state of the states' mandatory hospital medical error reporting six years after the release of the influential IOM report, "To Err is Human." The second aim was to identify barriers to reporting of medical errors by hospital personnel. The third aim was to identify hospital safety measures implemented to reduce medical errors and enhance patient safety. ^ Methods. A descriptive, longitudinal, retrospective design was used to address the first stated objective. The study data came from the twenty-one states with mandatory hospital reporting programs which report aggregate hospital error data that is accessible to the public by way of states' websites. The data analysis included calculations of expected number of medical errors for each state according to IOM rates. Where possible, a comparison was made between state reported data and the calculated IOM expected number of errors. A literature review was performed to achieve the second study aim, identifying barriers to reporting medical errors. The final aim was accomplished by telephone interviews of principal patient safety/quality officers from five Texas hospitals with more than 700 beds. ^ Results. The state medical error data suggests vast underreporting of hospital medical errors to the states. The telephone interviews suggest that hospitals are working at reducing medical errors and creating safer environments for patients. The literature review suggests the underreporting of medical errors at the state level stems from underreporting of errors at the delivery level. ^

Identification of maltreatment type in children with disabilities using the National Child Abuse and Neglect Data System (NCANDS)

This study was a retrospective design and used secondary data from the National Child Abuse and Neglect Data System (NCANDS), provided by the National Data Archive on Child Abuse and Neglect Family Life Development Center administered by Cornell University. The dataset contained information for the year 2005 on children from birth to 18 years of age. Child abuse and neglect for disabled children, was evaluated in-depth in the present study. Descriptive and statistical analysis was performed using the children with and without disabilities. It was found that children with disabilities have a lower rate of substantiation that likely indicates the interference of reporting due to their handicap. The results of this research demonstrate the important need to teach professionals and laypersons alike on how to recognize and substantiate abuse among disabled children.^

The movement toward patient safety: State action related to reporting and disclosure of healthcare-associated infections

Increasing attention has been given to the problem of medical errors over the past decade. Included within that focused attention has been a strong interest in reducing the occurrence of healthcare-associated infections (HAIs). Acting concurrently with federal initiatives, the majority of U.S. states have statutorily required reporting and public disclosure of HAI data. Although the occurrence of these state statutory enactments and other state initiatives represent a recognition of the strong concern pertaining to HAIs, vast differences in each state’s HAI reporting and public disclosure requirements creates a varied and unequal response to what has become a national problem.^ The purpose of this research was to explore the variations in state HAI legal requirements and other state mandates. State actions, including statutory enactments, regulations, and other initiatives related to state reporting and public disclosure mechanisms were compared, discussed, and analyzed in an effort to illustrate the impact of the lack of uniformity as a public health concern.^ The HAI statutes, administrative requirements, and other mandates of each state and two U.S. territories were reviewed to answer the following seven research questions: How far has the state progressed in its HAI initiative? If the state has a HAI reporting requirement, is it mandatory or voluntary? What healthcare entities are subject to the reporting requirements? What data collection system is utilized? What measures are required to be reported? What is the public disclosure mechanism? How is the underlying reported information protected from public disclosure or other legal release?^ Secondary publicly available data, including state statutes, administrative rules, and other initiatives, were utilized to examine the current HAI-related legislative and administrative activity of the study subjects. The information was reviewed and analyzed to determine variations in HAI reporting and public disclosure laws. Particular attention was given to the seven key research questions.^ The research revealed that considerable progress has been achieved in state HAI initiatives since 2004. Despite this progress, however, when reviewing the state laws and HAI programs comparatively, considerable variations were found to exist with regards to the type of reporting requirements, healthcare facilities subject to the reporting laws, data collection systems utilized, reportable measures, public disclosure requirements, and confidentiality and privilege provisions. The wide variations in state statutes, administrative rules, and other agency directives create a fragmented and inconsistent approach to addressing the nationwide occurrence of HAIs in the U.S. healthcare system. ^

Parental substance abuse as a risk factor for physical child abuse and neglect: A systematic review of the literature

Case control and retrospective studies have identified parental substance abuse as a risk factor for physical child abuse and neglect (Dore, Doris, & Wright, 1995, May; S. R. Dube et al., 2001; Guterman & Lee, 2005, May; Walsh, MacMillan, & Jamieson, 2003). The purpose of this paper is to present the findings of a systematic review of prospective studies from 1975 through 2005 that include parental substance abuse as a risk factor for physical child abuse or neglect. Characteristics of each study such as the research question, sample information, data collection methods and results, including the parent assessed and definitions of substance abuse and physical child abuse and neglect, are discussed. Five studies were identified that met the search criteria. Four of five studies found that parental substance abuse was a significant variable in predicting physical child abuse and neglect.^

A Su Salud Injury Prevention expansion: Analysis of injury prevention perceptions in a Hispanic community

Unintentional injury is the leading cause of death for American ages one to 44 and is ranked in the top ten causes of death for all age groups (CDC, 2006a). A Su Salud Injury Prevention was developed to address injury prevention awareness and education. The program is a mass media education campaign that uses role models, mass media, and community outreach to prevent injury. In 2009, University Health System (UHS) expanded the program. Baseline data were collected from 426 residents in targeted neighborhoods northwest of downtown San Antonio to support the expansion. The purpose of this study was to explore injury perceptions, knowledge, and behaviors of adults living in the expansion area, and define the predominant factors associated with these perceptions. A secondary aim was to assess community awareness and willingness to participate in the program.^ Survey results showed motor vehicle crashes (MVC), falls, drinking and driving, and guns and assaults were considered the most serious injures for adults. The most serious child injuries were MVC, abuse and neglect, falls, and head injuries. Residents were knowledgeable of state seatbelt policy, and over 90% responded as compliant for seatbelt and child car seat use. Most were knowledgeable about drinking and driving state policy and negative outcomes. However, 70% of those reporting driving under the influence of alcohol within the last year engaged in repeat high risk behavior. Men and residents under the age of 55 were more likely to engage in repeat drinking and driving (OR= 3.6, 7.0 respectively). Residents consider injury prevention an important issue, and have interest in a local injury prevention program. Younger women are the most likely to participate in a local program as potential role models and volunteers.^ Results from the study are summarized into an injury prevention and demographic profile of the community that will be used to develop tailored injury prevention messages to create a more effective program, and support program coordinators in effective community engagement. Results will also be used as a comparative basis for future evaluation of a behavioral injury prevention program focused on a predominantly Mexican-American community.^

Nursing-related medication errors: A review of factors that facilitate and hinder error reporting, and recommendations for improvement

Medication errors, one of the most frequent types of medical errors, are a common cause of patient harm in hospital systems today. Nurses at the bedside are in a position to encounter many of these errors since they are there at the start of the process (ordering/prescribing) and the end of the process (administration). One of the recommendations from the IOM (Institute of Medicine) report, "To Err is Human," was for organizations to identify and learn from medical errors through event reporting systems. While many organizations have reporting systems in place, research studies report a significant amount of underreporting by nurses. A systematic review of the literature was performed to identify contributing factors related to the reporting and not reporting of medication errors by nurses at the bedside.^ Articles included in the literature review were primary or secondary studies, dated January 1, 2000 – July 2009, related to nursing medication error reporting. All 634 articles were reviewed with an algorithm developed to standardize the review process and help filter out those that did not meet the study criteria. In addition, 142 article bibliographies were reviewed to find additional studies that were not found in the original literature search.^ After reviewing the 634 articles and the additional 108 articles discovered in the bibliography review, 41 articles met the study criteria and were used in the systematic literature review results.^ Fear of punitive reactions to medication errors was a frequent barrier to error reporting. Nurses fear reactions from their leadership, peers, patients and their families, nursing boards, and the media. Anonymous reporting systems and departments/organizations with a strong safety culture in place helped to encourage the reporting of medication errors by nursing staff.^ Many of the studies included in this literature review do not allow results that can be generalized. The majority of them took place in single institutions/organizations with limited sample sizes. Stronger studies with larger sample sizes need to be performed, utilizing data collection methods that have been validated, to determine stronger correlations between safety cultures and nurse error reporting.^

Ascertainment, meta-analysis and reporting of adverse reactions in clinical trials of antibiotics

The ascertainment and analysis of adverse reactions to investigational agents presents a significant challenge because of the infrequency of these events, their subjective nature and the low priority of safety evaluations in many clinical trials. A one year review of antibiotic trials published in medical journals demonstrates the lack of standards in identifying and reporting these potentially fatal conditions. This review also illustrates the low probability of observing and detecting rare events in typical clinical trials which include fewer than 300 subjects. Uniform standards for ascertainment and reporting are suggested which include operational definitions of study subjects. Meta-analysis of selected antibiotic trials using multivariate regression analysis indicates that meaningful conclusions may be drawn from data from multiple studies which are pooled in a scientifically rigorous manner. ^

Nurse likelihood to report a pediatric medication error: Examination of the "pre-reporting" period

Each year, hospitalized patients experience 1.5 million preventable injuries from medication errors and hospitals incur an additional $3.5 billion in cost (Aspden, Wolcott, Bootman, & Cronenwatt; (2007). It is believed that error reporting is one way to learn about factors contributing to medication errors. And yet, an estimated 50% of medication errors go unreported. This period of medication error pre-reporting, with few exceptions, is underexplored. The literature focuses on error prevention and management, but lacks a description of the period of introspection and inner struggle over whether to report an error and resulting likelihood to report. Reporting makes a nurse vulnerable to reprimand, legal liability, and even threat to licensure. For some nurses this state may invoke a disparity between a person‘s belief about him or herself as a healer and the undeniable fact of the error.^ This study explored the medication error reporting experience. Its purpose was to inform nurses, educators, organizational leaders, and policy-makers about the medication error pre-reporting period, and to contribute to a framework for further investigation. From a better understanding of factors that contribute to or detract from the likelihood of an individual to report an error, interventions can be identified to help the nurse come to a psychologically healthy resolution and help increase reporting of error in order to learn from error and reduce the possibility of future similar error.^ The research question was: "What factors contribute to a nurse's likelihood to report an error?" The specific aims of the study were to: (1) describe participant nurses' perceptions of medication error reporting; (2) describe participant explanations of the emotional, cognitive, and physical reactions to making a medication error; (3) identify pre-reporting conditions that make it less likely for a nurse to report a medication error; and (4) identify pre-reporting conditions that make it more likely for a nurse to report a medication error.^ A qualitative research study was conducted to explore the medication error experience and in particular the pre-reporting period from the perspective of the nurse. A total of 54 registered nurses from a large private free-standing not-for-profit children's hospital in the southwestern United States participated in group interviews. The results describe the experience of the nurse as well as the physical, emotional, and cognitive responses to the realization of the commission of a medication error. The results also reveal factors that make it more and less likely to report a medication error.^ It is clear from this study that upon realization that he or she has made a medication error, a nurse's foremost concern is for the safety of the patient. Fear was also described by each group of nurses. The nurses described a fear of several things including physician reaction, manager reaction, peer reaction, as well as family reaction and possible lack of trust as a result. Another universal response was the description of a struggle with guilt, shame, imperfection, blaming oneself, and questioning one's competence.^

Returning Texas Senate Bill 530 back to 1100 Congress Avenue: The need for effective surveillance reporting of student fitness levels to Texas house representatives

Every Texas student is required to complete the FITNESSGRAM fitness assessment under legislation outlined in Senate Bill 530. This study described cardiovascular, body mass index (BMI), and overall fitness levels of students (grades 3–12) in the state of Texas during the 2009–2010 school year, and provides examples of how to effectively present results to Texas House Representatives using three unique health communication strategies. Given the Texas legislature mandates FITNESSGRAM collection yet did not require reporting according to their election district, the data were aggregated to 150 Texas House Representative Districts by sex and grade category to facilitate effective fitness data dissemination. Fitness data were also analyzed with results from the Texas Assessment of Knowledge and Skills (TAKS) to provide insight into potential relationships between fitness and academic achievement. ^ The majority of students in Texas need improvement on at least 1 fitness assessment. In general, female students have superior fitness in elementary and middle school but the fitness edge is erased by high school. Female cardiovascular fitness deteriorates faster from elementary to high school compared to male students. Female BMI deteriorates and male BMI improves from elementary to high school. Cardiovascular fitness and overall fitness decreases from elementary to high school for both male and female students. ^ Student fitness was significantly and strongly independently correlated with academic achievement. Further analysis showed that House Representatives with TAKS scores in the top quartile consistently showed superior fitness. Small significant partial correlations remain between fitness and TAKS assessment after controlling for socioeconomic status. In general, correlations were stronger between female BMI and TAKS assessment compared to male students. Cardiovascular fitness was significantly correlated with TAKS assessment for both genders. This paper supports student fitness as a confounder in the relationship between socioeconomic status and academic achievement. Plus, student fitness has a strong correlation with academic that deserves further exploration. ^ Senate Bill 530 fails to organize and implement a health communication strategy that effectively disseminates the health data collected to stakeholders of interest. The lack of a vital health communication strategy results in an incomplete student health surveillance system. This paper outlines three unique strategies tailored to legislators. It is important to disseminate health information using a variety of methods tailored to your targeted audience. The use of interactive mapping technology presented (GIS) uses new technology that has the potential to effectively reach a large audience.^

Assessment of executive function before and after vitamin D replacement in vulnerable adults who self-neglect

Purpose: Self-neglect (SN) is the inability to maintain self-care needs. It is thought that older adults who have impaired executive function (EF) develop the inability to do self-care and to protect themselves. The specific aims were to (1) determine the feasibility of using multiple EF measures with community-dwelling elders with SN, (2) identify changes in EF between baseline and 5-months in community-dwelling elders with SN who receive 50,000 IU or 400 IU of oral vitamin D monthly and (2) explore changes in specific dimensions of EF between the groups. ^ Methods: Fifty adults, 65 years of age and older, were recruited from Adult Protective Services with confirmed SN. A research nurse administered the following tests at baseline and five-months: Delis-Kaplan Card Sort Test (D-KEFS), Executive Interview (EXIT 25), CLOX Drawing Test (CLOX I, II), Trails Making Test A and B (TMT A & B) and the Mini-Mental State Examination (MMSE). Demographic data was collected at baseline and serum 25-OHD levels were collected at baseline and five-months. ^ Results: Older adults with SN were more likely to fail the CLOX1 and D-KEFS, while passing the MMSE, CLOX II, TMT A & B and the EXIT 25. At five-months, the only statistically significant difference between groups was in the TMT A & B test scores; the control group did better than the treatment group. There was a non-significant increase in serum vitamin D levels for both groups and no difference between groups. ^ Conclusions: Results from this study provide support that individuals who SN will complete a battery of EF tests and that they exhibit the following impairments consistent with executive dysfunction: 'concept generation', 'planning', 'inhibition', and 'spatial working memory'. Utilizing only one EF measure in individuals with intact cognition may result in unidentification of individuals with executive dysfunction, thus delaying necessary treatment. Future studies should attempt to determine different etiologies of executive dysfunction and determine if early treatment can prevent or reverse SN. ^ Key Words: Self-neglect, Executive Dysfunction, Executive Function, Adult Protective Services, Community-dwelling, Vitamin D ^

Mistreatment and self-neglect in community dwelling older adults: Studies of construct validity, measurement invariance and latent classes

Mistreatment and self-neglect significantly increase the risk of dying in older adults. It is estimated that 1 to 2 million older adults experience elder mistreatment and self-neglect every year in the United States. Currently, there are no elder mistreatment and self-neglect assessment tools with construct validity and measurement invariance testing and no studies have sought to identify underlying latent classes of elder self-neglect that may have differential mortality rates. Using data from 11,280 adults with Texas APS substantiated elder mistreatment and self-neglect 3 studies were conducted to: (1) test the construct validity and (2) the measurement invariance across gender and ethnicity of the Texas Adult Protective Services (APS) Client Assessment and Risk Evaluation (CARE) tool and (3) identify latent classes associated with elder self-neglect. Study 1 confirmed the construct validity of the CARE tool following adjustments to the initial hypothesized CARE tool. This resulted in the deletion of 14 assessment items and a final assessment with 5 original factors and 43 items. Cross-validation for this model was achieved. Study 2 provided empirical evidence for factor loading and item-threshold invariance of the CARE tool across gender and between African-Americans and Caucasians. The financial status domain of the CARE tool did not function properly for Hispanics and thus, had to be deleted. Subsequent analyses showed factor loading and item-threshold invariance across all 3 ethnic groups with the exception of some residual errors. Study 3 identified 4-latent classes associated with elder self-neglect behaviors which included individuals with evidence of problems in the areas of (1) their environment, (2) physical and medical status, (3) multiple domains and (4) finances. Overall, these studies provide evidence supporting the use of APS CARE tool for providing unbiased and valid investigations of mistreatment and neglect in older adults with different demographic characteristics. Furthermore, the findings support the underlying notion that elder self-neglect may not only occur along a continuum, but that differential types may exist. All of which, have very important potential implications for social and health services distributed to vulnerable mistreated and neglected older adults.^

An evaluation of the centers for Medicare & Medicaid Services' Hospital Acquired Conditions and Present on Admission Indicator Reporting program

Objective: This dissertation evaluated three aspects of the Centers for Medicare and Medicaid Services' Hospital Acquired Conditions and Present on Admission Indicator Reporting program (HACPOA program) to produce three journal articles for publication. ^ Methods: All payer admission records from state inpatient databases from Arizona, New Jersey and Washington states were analyzed for the year 2008. However some analyses required a sample of adult only Medicare patients in the first two studies. California's inpatient data (2004 – 2010) was also analyzed in the third study to examine the reporting and non-payment program elements' impact on the incidence of hospital acquired conditions. ^ Results: Majority diagnoses reported in inpatient prospective payment systems hospitals were present on admission. However, some diagnoses are still coded as "not present on admission" and "insufficient documentation to determine whether or not conditions are present on admission or not". This is important because it reveals that hospital complications still occur in hospitals. Hospital fall and trauma injuries were the most common hospital acquired conditions observed in this study. Predictors of hospital fall injuries include age, gender, number of diagnoses, number of procedures, number of chronic conditions while predictors of hospital trauma injuries include number of e-codes, number of diagnoses and the presence of chronic conditions on a patient's admission records. Finally, the implementation of the present on admission reporting requirement increased reports of certain hospital acquired conditions while the non-payment policy element in the Hospital Acquired Conditions program reduced the incidence of hospital fall and trauma injuries in particular. ^ Conclusion: The implementation of the Hospital Acquired Conditions and Present on Admission Indicator Reporting program has made the state inpatient database a more useful source of data capable of now identifying hospital complications. The reporting and nonpayment program elements in the HACPOA program have also impacted the incidence of hospital acquired conditions. ^