Thrombosis incidence in major paediatric burns.

BACKGROUND: Major burns are associated with multiple risk factors for thrombosis such as decreased mobilization and systemic inflammation. It is unclear if these factors are offset by the inherent lower thrombosis risk in the paediatric patient. As such there is no consensus on thromboprophylaxis for paediatric burns patients, in contrast to this being a mainstay of treatment in the adult population. This retrospective cohort study examines the incidence of, and risk factors for, thrombotic events in major paediatric burns with a view to establish guidelines for prevention. METHOD: Review of major paediatric burns, defined as % total body surface area (%TBSA) ≥30%, at the Adelaide Women's and Children's Hospital (WCH) over a 16-year period. Coding data and the local burns database were used to identify participants with subsequent review of case files. RESULTS: Of the cohort (n = 23), six cases (26%) were complicated by thrombotic events. These patients had the most extensive burns averaging 68.5% TBSA, longer PICU admissions and associated interventions. These data points were more than doubled in the cohort diagnosed with a thrombus. Of the six events, five were secondary to central venous catheters (CVC) and one deep venous thrombosis (DVT) to the left calf. CONCLUSION: The incidence of thrombotic events in our study was significant albeit in a small population. There is a strong association between large %TBSA and thrombus, with clots mostly forming around CVCs. While further research is required, this study demonstrates screening and targeted thromboprophylaxis may be required for major paediatric burns.

Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)-a company experience.

INTRODUCTION: In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of the dossier for initial marketing authorization of a medicinal product or with an application involving a significant change to an existing marketing authorization. A comprehensive revision of the EU Guideline on Good Pharmacovigilance Practices (GVP) Module V-Risk Management Systems (Revision [Rev] 2), adopted in March 2017, provides a framework for developing more focused, actionable, and risk-proportionate RMPs. This paper describes the Janssen experience with the interpretation and application of GVP Module V (Rev 2) regarding the evaluation of safety concerns in an RMP. METHODS: Janssen convened a cross-functional working group to promote consistent interpretation of the GVP Module V (Rev 2) guidance across therapeutic areas. The group created 3 algorithms to support implementation of the guidance related to removal or reclassification of safety concerns by product-specific RMP teams. RESULTS: Following implementation of the GVP Module V (Rev 2) guidance, the algorithm-driven process led to a substantial decrease in the number of safety concerns for most products. With few exceptions, EU health authorities agreed with the proposed safety concern removals or reclassifications, resulting in RMPs that were focused on only those safety concerns that required further characterization or specific risk minimization. CONCLUSIONS: The algorithm-driven process allows for consistent interpretation and application of the GVP Module V (Rev 2) guidance, which enables product teams to develop an actionable RMP using a thoughtful, evaluative, science-based approach that considers all available evidence.

The regression of the bovine tuberculin reaction: Results from the Reactor Quality Assurance study in Northern Ireland.

Tuberculin skin tests remain widely used in the control of bovine tuberculosis (bTB) in cattle. Little is known about the rate of regression of tuberculin reactions after the comparative intradermal cervical test (CICT) in cattle. This study aimed to collect data to describe tuberculin regression in reactors following the CICT at 72 ± 4 h post injection. Reactors were also tested using the interferon gamma (IFN-γ) assay to establish if any pattern existed between these results and the CICT reaction regression. The data were derived from 108 herds, 112 herd-level CICTs and 1008 animals. A multivariable linear mixed model was built to explore the regression of the bovine tuberculin reaction over time and the influence of potential predictors. The results confirmed a proportional decline in the bovine tuberculin reaction occurred over time. The predictors in the final model demonstrated that regression of the tuberculin reaction differed between reactors according to their IFN-γ test results and whether visible lesions were present at slaughter. Follow-up measurement of tuberculin reactions and the serial use of the IFN-γ assay in large breakdowns has the potential to provide both a mechanism for quality assurance of the current CICT bTB surveillance and the identification of atypical breakdowns or reactors requiring further investigation.

Positive distraction for children during burn wound care in Australia - An evaluation of the 'Captains on Call' pilot.

INTRODUCTION: Burn wound care procedures can cause severe pain to the child, and distress for both the child and caregivers. We evaluated a new Starlight Children's Foundation program, 'Captains on Call', which aims to provide positive distraction during burn wound care procedures to reduce the child's anxiety and pain. This paper presents a preliminary evaluation, using a qualitative design, of Captains on Call at the Women's and Children's Hospital, Australia. METHODS: We conducted interviews with caregivers (n = 18), patients (n = 6), nurses (n = 5) and Captain Starlights (n = 3). Interviews focused on program impact and recommendations for how to improve the program. RESULTS: We identified seven themes: (1) positive distraction from pain and boredom, (2) benefit of additional support, (3) creating positive memories of the hospital, (4) catering for unique needs of each patient and family, (5) general appreciation, (6) importance of regular visits, and (7) a desire to expand the program. All caregivers, nurses and patients reported that they were likely to recommend the program to others. CONCLUSION: This study provides early evidence to support the benefit of the Captains on Call program to families and health professionals, as well as the feasibility in providing this integrated care.

A comparison study of methods for estimation of a burn surface area: Lund and Browder, e-burn and Mersey Burns.

INTRODUCTION: One of the greatest challenges in burn care is the estimation of a total burn surface area (TBSA). It is especially challenging and needs to take into account the growing proportions and the age of a paediatric patient. The aims of this study is to: (1) assess the reliability of the three modalities (LB, MB, and EB) in calculating the extent of burn injuries and fluid resuscitation, and (2) compare the features in terms of usability and efficacy. METHODS: Participants were recruited from Women's and Children's Hospital (WCH), South Australia's surgical and emergency department. Participants were introduced to LB, MB and EB, and then commenced calculation of TBSA on two simulated paediatric (patient A: 12 months, patient B: 4 years) burns. The participants were categorized into three groups; (1) Burns-naïve, (2) Burns-experienced, and (3) Burns-expert. RESULTS: A total of 45 participants took part in this validation study: doctors (49%), nurses (33%), nursing students (11%) and medical students (7%). The burns-naïve group demonstrated higher means in both patients and has greater variance, TBSA mean 28.8%, range 14-40.5% and mean 37.4%, range 20-52.3% in patient A and B respectively. Two-way ANOVA analysis shows a statistically significant interaction between the effects of level of experience and use of applications on estimation of TBSA in larger burns. CONCLUSION: Innovative software and mobile applications demonstrate a high potential as clinical adjuncts in achieving better health outcomes in any health care system. Both Mersey Burns and e-burn reduced the risk of human error particularly from untrained or non-specialised clinicians, however, e-burn proved to be more favourable in our study. Technology-aided models are the future of burns assessment, and further studies are warranted to determine their impact on overall clinical outcome.

Mortality in paediatric burns at the Women's and Children's Hospital (WCH), Adelaide, South Australia: 1960-2017.

BACKGROUND: Burn injuries are the third leading cause of preventable death in children worldwide, resulting in over 100 000 annual hospitalisations. In the paediatric population, scalds are the commonest mechanism and burn injuries of greater than 40% total burn surface area (TBSA) are associated with a high mortality and morbidity rate. AIMS: The aim of this study was to review mortality in paediatric burns in a tertiary burns centre over a 60-year period, providing an understanding of local causes of mortality and directing future clinical research. METHODS: We reviewed data collected prospectively from patients treated for burn injuries at the WCH from 1960 to 2017. Data of age, gender, mechanism of injury and TBSA were collected. TBSA of 40% and greater were included in the study. RESULTS: All patients with total burn surface area (TBSA) less than 40% survived. There were a total of 75 patients who sustained burns of or greater than 40% TBSA. Overall mortality was 34% (26 of 75) of which 24 occurred in the 1960s. Of the 21 patients who died of flame burn injuries, 12 of them were described as clothes catching alight from being in close proximity to the source of flame. Average length of stay for patients who did not survive was 7 days (1-26). CONCLUSION: Mortality has since declined and the prognosis for survival good, even in TBSA of greater than 90%. The investigations in fabric flammability led by Dr Thomas Pressley and Mr Murray Clarke prompted the rewriting of Australian standards for production of children's clothing. This, in combination with advances in paediatric resuscitation, surgical techniques as well as wound care has improved survival rates and outcomes in extensive burn injuries. Future studies focus to see not only better survival rates, but also better aesthetic and functional outcomes in burn survivors.

Gender and Country Differences in Alcohol-Aggression Expectancy and Alcohol-Related Intimate Partner Violence.

Alcohol use is associated with a higher rate of violent offending among males and a higher rate of violent victimization among females, especially for Intimate Partner Violence (IPV). Using comparable self-reported data from the GENACIS Project, the present study examines between the United States (n=2,363) and Japan (n=1,660) whether the expected gender difference in alcohol-related IPV is explained by alcohol-aggression expectancy. The results indicate that though males are more likely than females to expect that alcohol would make them more aggressive, alcohol-aggression expectancy has a very little to do with the gender difference in alcohol-related IPV. In both countries, overall, alcohol use of males, irrespective of their alcohol-aggression expectancy, most strongly and directly accounted for the gender difference in alcohol-related IPV.

How does paid sick leave relate to health care affordability and poverty among US workers?

Secondary data analysis on the 2015 National Health Interview Survey was conducted to determine if having paid sick leave increases the odds of being able to afford specific health care goods and services, and not having access to paid sick leave increases the odds of being in poverty, being food insecure and having elevated medical costs among a representative sample of US workers age 18-64. We found a statistically significant association between paid sick leave and ability to afford dental care, eyeglasses and prescription medication. Workers who lack paid sick leave are more likely than those with paid sick leave to be in poverty and have high medical costs. In conclusion, we found a relationship between paid sick leave benefits and being able to afford needed healthcare services and goods and being more vulnerable to economic hardship.

Paid sick leave status in relation to government sponsored welfare utilization.

Nearly a third of all U.S. workers, primarily lower-paid employees, do not have paid sick leave benefits, prompting some lawmakers to consider mandating paid sick leave for all U.S. employees so workers can access timely health care without lost wages. A representative sample of 19,537 workers in current paid employment was examined, searching for the association between access to paid sick leave benefits and receipt of six different welfare and welfare-related services. After controlling for relevant demographic, work, income, and medical/health care variables, results of the logistic models indicate that, among working adults age 18-64, those without paid sick leave are 1.41 times more likely to receive income from a state or county welfare program, 1.36 times more likely to receive other welfare assistance (transportation and child care supports), 1.33 times more likely to received sponsored rental assistance, and 1.34 times more likely to receive Supplemental Nutrition Assistance Program benefits (referred to as food stamps commonly and in this article). Mandating paid sick leave benefits may impact usage of social welfare assistance since families with paid sick leave do not have to lose wages when work is missed because of health and caregiver responsibilities. (PsycINFO Database Record

How Many Paid Sick Days Are Enough?

OBJECTIVE: This study analyzes the relationship between number of paid sick days and reported preventive health care service usage among older US workers. METHODS: Using a 2014 cross-section of 3235 US workers age 49 to 57 from the National Longitudinal Survey of Youth, this study is the first to measure paid sick leave as an ordinal variable in an effort to refine our understanding of sick leave, and identify the ideal range of sick days necessary for people to access preventive health care services. RESULTS: We find workers with 10 or more paid sick days have increased odds of reporting five different preventive health care services. CONCLUSION: To support worker and public health, policy planners may want to consider the number of paid sick days that are needed before changes in preventive service use are observed.

Association between α1-antitrypsin and bronchiectasis in patients with humoral immunodeficiency receiving gammaglobulin infusions.

BACKGROUND: In patients with humoral immunodeficiency, the progression of bronchiectasis has been known to occur despite adequate gammaglobulin therapy and in the absence of recurrent infections. This observation suggests that factors other than gammaglobulin replacement might play a part in the prevention of lung damage in this population. α1-Antitrypsin deficiency can be associated with bronchiectasis, a chronic inflammatory lung disease. The protective levels of α1-antitrypsin and phenotype in preventing bronchiectasis have not been thoroughly studied in the immunodeficient population. We hypothesized that patients with humoral immunodeficiencies on gammaglobulin infusions and bronchiectasis have lower median levels, but not necessary "classically" deficient levels, of α1-antitrypsin compared with those without bronchiectasis. OBJECTIVE: To compare levels of α1-antitrypsin in subjects with immunodeficiency with and without bronchiectasis. METHODS: One hundred ninety-two subjects with humoral immunodeficiencies requiring gammaglobulin therapy had their α1-antitrypsin levels and phenotype screened. High-resolution computed tomograms of the chest of participants were obtained and compared with α1-antitrypsin levels and phenotype. RESULTS: Participants without bronchiectasis were found to have higher median levels of α1-antitrypsin than those with bronchiectasis (P = .003). Furthermore, subjects with improving or resolved bronchiectasis since initiating gammaglobulin therapy had higher median levels of α1-antitrypsin than those with worsening bronchiectasis (P = .004). The prevalence of the α1-antitrypsin PiZZ mutation was higher than in the general public (P < .0001). CONCLUSION: Median α1-antitrypsin levels and phenotype in subjects were associated with humoral immunodeficiency and their bronchiectasis status. Prospective studies might be necessary to determine possible benefits of augmentation therapy. This study supports the idea that what is considered a "normal or protective" α1-antitrypsin range might need to be refined for patients with humoral immunodeficiency on gammaglobulin therapy.

Paid sick leave and psychological distress: An analysis of U.S. workers.

Paid sick leave is increasingly identified as a social justice issue having important implications for health and wellness; however, little is known about its relationship to mental health. Data from the 2015 cross section of the National Health Interview Survey (NHIS; 2015) were used to examine the relationship between paid sick leave and psychological distress during the last 30 days among N = 17,897 working United States adults. The 6-item Kessler Psychological Distress Scale (K6), a valid and reliable instrument for assessing psychological distress in population based samples, was used to measure the outcome variable of interest. The K6 score was computed from 6 questions and was regressed on paid sick leave status, after controlling for variables known to be related to psychological distress. Results indicated that workers who lack paid sick leave benefits report a statistically significant higher level of psychological distress, and are 1.45 times more likely to report their distress symptoms interfere a lot with their life or activities compared with workers with paid sick leave. This research adds to a body of work analyzing institutional structures and social determinants of health. Findings support the potential value of paid sick leave as an intervention to promote behavioral health. (PsycINFO Database Record

The Gender Difference in the Association between Early Onset of Drinking and Problem Drinking between the U.S. and Japan.

Using comparable survey data from the GENACIS Project, collected from representative samples of people aged 20 to 70 years old in the U.S. (n=2,598) and Japan (n=1,734), this study examined, across these two diverse societies, the gender difference in the association between the early onset of drinking and the development of drinking problems. The results of this study suggest that there does not appear to be a cross-national causal relationship between the early onset of drinking and problem drinking because of significant country and gender variations in this association and because there is no association found among Japanese females. As hypothesized, the early onset of drinking predicted problem drinking among males more strongly than among females in both countries.

Paid sick leave and preventive health care service use among U.S. working adults.

Managing work and health care can be a struggle for many American workers. This paper explored the relationship between having paid sick leave and receiving preventive health care services, and hypothesized that those without paid sick leave would be less likely to obtain a range of preventive care services. In 2016, cross-sectional data from a sample of 13,545 adults aged 18-64 with current paid employment from the 2015 National Health Interview Survey (NHIS) were examined to determine the relationship between having paid sick leave and obtaining eight preventive care services including: (1) blood pressure check; (2) cholesterol check; (3) fasting blood sugar check; (4) having a flu shot; (5) having seen a doctor for a medical visit; (6) getting a Pap test; (7) getting a mammogram; (8) getting tested for colon cancer. Findings from multivariable logistic regressions, holding 10 demographic, work, income, and medical related variables stable, found respondents without paid sick leave were significantly less likely to report having used six of eight preventive health services in the last 12months. The significant findings remained robust even for workers who had reported having been previously told they had risk factors related to the preventive services. These findings support the idea that without access to paid sick leave, American workers risk foregoing preventive health care which could lead to the need for medical care at later stages of disease progression and at a higher cost for workers and the American health care system as a whole.

Workers Without Paid Sick Leave Less Likely To Take Time Off For Illness Or Injury Compared To Those With Paid Sick Leave.

Paid sick leave is an important employer-provided benefit that helps people obtain health care for themselves and their dependents. But paid sick leave is not universally available to US workers. Little is known about paid sick leave and its relationship to health behaviors. Contrary to public health goals to reduce the spread of illness, our findings indicate that in 2013 both full- and part-time working adults without paid sick leave were more likely than workers with that benefit to attend work when ill. Those without paid sick leave were 3.0 times more likely to forgo medical care for themselves and 1.6 times more likely to forgo medical care for their family compared to working adults with paid sick leave benefits. Moreover, the lowest-income group of workers without paid sick leave were at the highest risk of delaying and forgoing medical care for themselves and their family members. Policy makers should consider the potential public health implications of their decisions when contemplating guaranteed sick leave benefits.

Understanding burn injuries in Aboriginal and Torres Strait Islander children: protocol for a prospective cohort study.

INTRODUCTION: Although Aboriginal and Torres Strait Islander children in Australia have higher risk of burns compared with non-Aboriginal children, their access to burn care, particularly postdischarge care, is poorly understood, including the impact of care on functional outcomes. The objective of this study is to describe the burden of burns, access to care and functional outcomes in Aboriginal and Torres Strait Islander children in Australia, and develop appropriate models of care. METHODS AND ANALYSIS: All Aboriginal and Torres Strait Islander children aged under 16 years of age (and their families) presenting with a burn to a tertiary paediatric burn unit in 4 Australian States (New South Wales (NSW), Queensland, Northern Territory (NT), South Australia (SA)) will be invited to participate. Participants and carers will complete a baseline questionnaire; follow-ups will be completed at 3, 6, 12 and 24 months. Data collected will include sociodemographic information; out of pocket costs; functional outcome; and measures of pain, itch and scarring. Health-related quality of life will be measured using the PedsQL, and impact of injury using the family impact scale. Clinical data and treatment will also be recorded. Around 225 participants will be recruited allowing complete data on around 130 children. Qualitative data collected by in-depth interviews with families, healthcare providers and policymakers will explore the impact of burn injury and outcomes on family life, needs of patients and barriers to healthcare; interviews with families will be conducted by experienced Aboriginal research staff using Indigenous methodologies. Health systems mapping will describe the provision of care. ETHICS AND DISSEMINATION: The study has been approved by ethics committees in NSW, SA, NT and Queensland. Study results will be distributed to community members by study newsletters, meetings and via the website; to policymakers and clinicians via policy fora, presentations and publication in peer-reviewed journals.

Unintentional prescription drug non-compliance for financial reasons in families with a child with a limiting health condition.

Area probability sampling via U.S. postal addresses was used to select households from seven high poverty U.S. metropolitan areas. In person and telephone interviews with one adult household member were used to determine the odds of delaying or failing to fill a needed prescription for families with a child member with a limiting health condition. Logistic models indicate families with a child with a limiting health condition are 1.57 times more likely to delay or fail to fill a needed prescription, and families with more than one child with a limiting condition are 1.85 times more likely. Implications are set forth.

Diagnosis of infection after splenectomy for trauma should be based on lack of platelets rather than white blood cell count.

BACKGROUND: There is a lack of evidence-based criteria to assist the diagnosis of infection following trauma splenectomy (TS). However, the literature suggests that white blood cell count (WBC) is associated with infection in patients who undergo TS. We sought to find whether there exist key differences in laboratory and clinical parameters that can assist the diagnosis of infection after TS. METHODS: We evaluated all consecutive trauma patients who had undergone TS at a Level 1 trauma center from 2005 to 2011 for the development of infection. To do this, we compared the values of demographic, laboratory, and clinical variables of infected and non-infected patients on odd post-operative days (POD) in the period from 1-15 days after TS. RESULTS: Of 127 patients who underwent TS, 25 died within 48 h after the procedure and were excluded from our analysis, leaving, 102 patients for investigation. In the 41 (40%) patients who developed an infection, the mean day for the first infectious episode was POD 7 (range, POD 4-14). The three most common infections were pneumonia (51%), urinary tract infection (24%), and bacteremia (20%). An evaluation of laboratory and clinical parameters showed no differences in the WBC of the patients who did and did not develop infections at any time in the 15 d after TS. However, the platelet count was statistically significantly higher in non-infected patients on POD 3-9 and on POD 13, and maximal body temperature was statistically significantly higher in the infected group of patients during the first week after TS. Differences in laboratory and clinical values of the infected and non-infected patients were greatest on POD 5. CONCLUSIONS: Patients who undergo TS have high rates of infectious complications. The WBC is not a reliable predictor of infection in these patients in the 2 wks following TS. However, patients who do not develop infection after TS have statistically significantly higher absolute platelet counts and rates of change in their daily platelet counts than those who develop infection.

Paediatric sunburn: the experience of an Australian paediatric burns unit.

AIM: The number of hospital presentations and admissions for treatment of sunburn remains significant, despite efforts to educate the public regarding sun protection. Current literature chiefly examines public health campaigns and sun protection behaviours and attitudes. There are very few articles that explore paediatric sunburn requiring hospital presentation. This study was therefore undertaken to provide a snapshot of this issue and to identify patterns and causative factors in the development of severe sunburn requiring hospital presentation. METHODS: Data were collected for retrospective analysis from case records of patients who presented with sunburn and were registered on the Burns Service database at the Women's and Children's Hospital in South Australia. This study includes patients who presented during the period of October 2006 to March 2011. RESULTS: There were 81 cases identified over the period of 2006-2011 from the Burns database that had sufficient information for the purpose of this study. Factors such as outdoor activity and water sports were predictably apparent, with patients being burned on days with extremely high ultraviolet ratings. Key patterns that emerged were location of sunburn and sun protection use, which were gender and age specific. CONCLUSION: Larger-scale studies are warranted to further delineate the contributing factors and to identify the specific populations of children at risk of sunburn. Future educational programmes can therefore target these subgroups and behaviours for effective prevention of sunburn. Tailored campaigns that address these factors may be of greater impact in reducing hospital presentations and admissions of significant sunburn.