Associations between maternal serum free beta human chorionic gonadotropin (β-hCG) levels and adverse pregnancy outcomes.

PubMed

Sirikunalai, P; Wanapirak, C; Sirichotiyakul, S; Tongprasert, F; Srisupundit, K; Luewan, S; Traisrisilp, K; Tongsong, T

2016-01-01

The objective was to determine the strength of relationship between maternal free beta human chorionic gonadotropin (β-hCG) concentrations and rates of adverse pregnancy outcomes. Consecutive records of the database of our Down screening project were assessed for free β-hCG levels and pregnancy outcomes. Pregnancies with foetal chromosomal or structural anomalies and those with underlying disease were excluded. Free β-hCG levels of < 0.5, > 0.5 and < 2.0, and ≥ 2.0 MoM were categorised as low, normal and high, respectively. Of 17,082 screened women, 13,620 were available for analysis. In the first trimester (n = 8150), low β-hCG levels significantly increased risk for intrauterine growth restriction (IUGR), preterm birth, low birth weight (LBW) and low Apgar score with relative risk of 1.66, 1.43, 1.83 and 2.89; whereas high β-hCG group had a significant decreased risk of preterm birth and GDM with relative risk of 0.73 and 0.62. In the second trimester (n = 5470), both low and high β-hCG groups had significant increased risks of the most common adverse outcomes, i.e. spontaneous abortion, IUGR and preterm birth. In conclusion, abnormally low (< 0.5MoM) or high (> 2.0 MoM) free β-hCG levels are generally associated with an increased risk of adverse pregnancy outcomes. Nevertheless, high free β-hCG levels in the first trimester may possibly decrease risk of preterm delivery and GDM.

The risky business of being an entomologist: A systematic review.

PubMed

Stanhope, Jessica; Carver, Scott; Weinstein, Philip

2015-07-01

Adverse work-related health outcomes are a significant problem worldwide. Entomologists, including arthropod breeders, are a unique occupational group exposed to potentially harmful arthropods, pesticides, and other more generic hazards. These exposures may place them at risk of a range of adverse work-related health outcomes. To determine what adverse work-related health outcomes entomologists have experienced, the incidence/prevalence of these outcomes, and what occupational management strategies have been employed by entomologists, and their effectiveness. A systematic search of eight databases was undertaken to identify studies informing the review objectives. Data pertaining to country, year, design, work-exposure, adverse work-related health outcomes, incidence/prevalence of these outcomes, and occupational management strategies were extracted, and reported descriptively. Results showed entomologists experienced work-related allergies, venom reactions, infections, infestations and delusional parasitosis. These related to exposure to insects, arachnids, chilopods and entognathans, and non-arthropod exposures, e.g. arthropod feed. Few studies reported the incidence/prevalence of such conditions, or work-related management strategies utilised by entomologists. There were no studies that specifically investigated the effectiveness of potential management strategies for entomologists as a population. Indeed, critical appraisal analysis indicated poor research quality in this area, which is a significant research gap. Entomologists are a diverse, unique occupational group, at risk of a range of adverse work-related health outcomes. This study represents the first systematic review of their work-related health risks. Future studies investigating the prevalence of adverse work-related health outcomes for entomologists, and the effectiveness of management strategies are warranted to decrease the disease burden of this otherwise understudied group. Copyright © 2015 Elsevier Inc. All rights reserved.

Poor nutritional status is associated with other geriatric domain impairments and adverse postoperative outcomes in onco-geriatric surgical patients - A multicentre cohort study.

PubMed

Huisman, M G; Veronese, G; Audisio, R A; Ugolini, G; Montroni, I; de Bock, G H; van Leeuwen, B L

2016-07-01

Nutritional status (NS), though frequently affected in onco-geriatric patients, is no standard part of a geriatric assessment. The aim of this study was to analyse the association between a preoperatively impaired NS and geriatric domain impairments and adverse postoperative outcomes in onco-geriatric surgical patients. 309 patients ≥70 years undergoing surgery for solid tumours were prospectively recruited. Nine screening tools were preoperatively administered as part of a geriatric assessment. NS was based on BMI, weight loss and food intake. Odds ratio's (OR) and 95% confidence intervals (95% CI) were estimated using logistic regression analysis. The occurrence of 30-day adverse postoperative outcomes was recorded. At a median age of 76 years, 107 patients (34.6%) had an impaired NS. Decreased performance status and depression were associated with an impaired NS, when adjusted for tumour characteristics and comorbidities (ORPS>1 3.46; 95% CI 1.56-7.67. ORGDS>5 2.11; 95% CI 1.05-4.26). An impaired NS was an independent predictor for major complications (OR 3.3; 95% CI 1.6-6.8). Ten out of 11 patients who deceased had an impaired NS. An impaired NS is prevalent in onco-geriatric patients considered to be fit for surgery. It is associated with decreased performance status and depression. An impaired NS is a predictor for adverse postoperative outcomes. NS should be incorporated in a geriatric assessment. Copyright © 2016 Elsevier Ltd. All rights reserved.

Early Childhood Adversity and Pregnancy Outcomes

PubMed Central

Smith, Megan V.; Gotman, Nathan; Yonkers, Kimberly A.

2016-01-01

Objectives To examine the association between adverse childhood experiences (ACEs) and pregnancy outcomes; to explore mediators of this association including psychiatric illness and health habits. Methods Exposure to ACEs was determined by the Early Trauma Inventory Self Report Short Form; psychiatric diagnoses were generated by the Composite International Diagnostic Interview administered in a cohort of 2303 pregnant women. Linear regression and structural equation modeling bootstrapping approaches tested for multiple mediators. Results Each additional ACE decreased birth weight by 16.33 g and decreased gestational age by 0.063. Smoking was the strongest mediator of the effect on gestational age. Conclusions ACEs have an enduring effect on maternal reproductive health, as manifested by mothers’ delivery of offspring that were of reduced birth weight and shorter gestational age. PMID:26762511

Born early and born poor: An eco-bio-developmental model for poverty and preterm birth.

PubMed

Brumberg, H L; Shah, S I

2015-01-01

Poverty is associated with adverse long-term cognitive outcomes in children. Poverty is also linked with preterm delivery which, in turn, is associated with adverse cognitive outcomes. However, the extent of the effect of poverty on preterm delivery, as well as proposed mechanisms by which they occur, have not been well described. Further, the impact of poverty on preterm school readiness has not been reviewed. As the childhood poverty level continues to increase in the U.S., we examine the evidence around physiological, neurological, cognitive and learning outcomes associated with prematurity in the context of poverty. We use the evidence gathered to suggest an Eco-Bio-Developmental model, emphasizing poverty as a toxic stress which predisposes preterm birth and which, via epigenetic forces, can continue into the next generation. Continued postnatal social disadvantage for these developmentally high-risk preterm infants is strongly linked with poor neurodevelopmental outcomes, decreased school readiness, and decreased educational attainment which can perpetuate the poverty cycle. We suggest social remedies aimed at decreasing the impact of poverty on mothers, fathers, and children which may be effective in reducing the burden of preterm birth.

A Network of AOPs for reduced thyroid hormone synthesis derived from inhibition of Thyroperoxidase - A common Molecular Initiating Event Leading to Species-Specific Indices of Adversity.

EPA Science Inventory

This collection of 3 AOPs describe varying outcomes of adversity dependent upon species in response to inhibition of thyroperoxidase (TPO) during development. Chemical inhibition of TPO, the molecular-initiating event (MIE), results in decreased thyroid hormone (TH) synthesis, a...

Combined approaches using adverse outcome pathways and big data to find potential diseases associated with humidifier disinfectant

PubMed Central

2017-01-01

According to previous survey, about two million of people were expected to suffer from toxic effects due to humidifier disinfectant (HD), regardless of healing or not. Extremely small group are recognized as HDs’ victims. Up to now, previous research tried to focus on interstitial fibrosis on terminal bronchiole because it is specific finding, compared with other diseases. To figure out overall effects from HDs, we recommend adverse outcome pathways (AOPs) as new approach. Reactive oxygen species (ROS) generation, decreased T-cell and pro-inflammatory cytokine release from macrophage could be key events between the exposure to HDs and diseases. ROS generation, decreased cell and pro-inflammatory cytokine release from macrophage could be cause of interstitial fibrosis, pneumonia and many other diseases such as asthma, allergic rhinitis, allergic dermatitis, fetal death, premature baby, autoimmune disease, hepatic toxicity, renal toxicity, cancer, and so on. We predict potential disease candidate by AOPs. We can validate the real risk of the adverse outcome by epidemiologic and toxicologic study using big data such as National Health Insurance data and AOPs knowledge base. Application of these kinds of new methods can find the potential disease list from the exposure to HD. PMID:28111421

Combined approaches using adverse outcome pathways and big data to find potential diseases associated with humidifier disinfectant.

PubMed

Leem, Jong-Han; Chung, Kyu Hyuck

2016-01-01

According to previous survey, about two million of people were expected to suffer from toxic effects due to humidifier disinfectant (HD), regardless of healing or not. Extremely small group are recognized as HDs' victims. Up to now, previous research tried to focus on interstitial fibrosis on terminal bronchiole because it is specific finding, compared with other diseases. To figure out overall effects from HDs, we recommend adverse outcome pathways (AOPs) as new approach. Reactive oxygen species (ROS) generation, decreased T-cell and pro-inflammatory cytokine release from macrophage could be key events between the exposure to HDs and diseases. ROS generation, decreased cell and pro-inflammatory cytokine release from macrophage could be cause of interstitial fibrosis, pneumonia and many other diseases such as asthma, allergic rhinitis, allergic dermatitis, fetal death, premature baby, autoimmune disease, hepatic toxicity, renal toxicity, cancer, and so on. We predict potential disease candidate by AOPs. We can validate the real risk of the adverse outcome by epidemiologic and toxicologic study using big data such as National Health Insurance data and AOPs knowledge base. Application of these kinds of new methods can find the potential disease list from the exposure to HD.

Does Decreased Access to Emergency Departments Affect Patient Outcomes? Analysis of Acute Myocardial Infarction Population 1996–2005

PubMed Central

Shen, Yu-Chu; Hsia, Renee Y

2012-01-01

Objective We analyze whether decreased emergency department (ED) access results in adverse patient outcomes or changes in the patient health profile for patients with acute myocardial infarction (AMI). Data We merge Medicare claims, American Hospital Association annual surveys, Medicare hospital cost reports, and location information for 1995–2005. Study Design We define four ED access change categories and estimate a ZIP Code fixed-effects regression models on the following AMI outcomes: mortality rates, age, and probability of percutaneous transluminal coronary angioplasty (PTCA) on day of admission. Principal Findings We find a small increase in 30-day to 1-year mortality rates among patients in communities that experience a <10-minute increase in driving time. Among patients in communities with >30-minute increases, we find a substantial increase in long-term mortality rates, a shift to younger ages (suggesting that older patients die en route), and a higher probability of immediate PTCA. Most of the adverse effects disappear after the transition years. Conclusions Deterioration in geographic access to ED affects a small segment of the population, and most adverse effects are transitory. Policy planners can minimize the adverse effects by providing assistance to ensure adequate capacity of remaining EDs, and facilitating the realignment of health care resources during the critical transition periods. PMID:22091922

The Identification of Seniors at Risk (ISAR) score to predict clinical outcomes and health service costs in older people discharged from UK acute medical units.

PubMed

Edmans, Judi; Bradshaw, Lucy; Gladman, John R F; Franklin, Matthew; Berdunov, Vladislav; Elliott, Rachel; Conroy, Simon P

2013-11-01

tools are required to identify high-risk older people in acute emergency settings so that appropriate services can be directed towards them. to evaluate whether the Identification of Seniors At Risk (ISAR) predicts the clinical outcomes and health and social services costs of older people discharged from acute medical units. an observational cohort study using receiver-operator curve analysis to compare baseline ISAR to an adverse clinical outcome at 90 days (where an adverse outcome was any of death, institutionalisation, hospital readmission, increased dependency in activities of daily living (decrease of 2 or more points on the Barthel ADL Index), reduced mental well-being (increase of 2 or more points on the 12-point General Health Questionnaire) or reduced quality of life (reduction in the EuroQol-5D) and high health and social services costs over 90 days estimated from routine electronic service records. two acute medical units in the East Midlands, UK. a total of 667 patients aged ≥70 discharged from acute medical units. an adverse outcome at 90 days was observed in 76% of participants. The ISAR was poor at predicting adverse outcomes (AUC: 0.60, 95% CI: 0.54-0.65) and fair for health and social care costs (AUC: 0.70, 95% CI: 0.59-0.81). adverse outcomes are common in older people discharged from acute medical units in the UK; the poor predictive ability of the ISAR in older people discharged from acute medical units makes it unsuitable as a sole tool in clinical decision-making.

Risk factors and screening instruments to predict adverse outcomes for undifferentiated older emergency department patients: a systematic review and meta-analysis.

PubMed

Carpenter, Christopher R; Shelton, Erica; Fowler, Susan; Suffoletto, Brian; Platts-Mills, Timothy F; Rothman, Richard E; Hogan, Teresita M

2015-01-01

A significant proportion of geriatric patients experience suboptimal outcomes following episodes of emergency department (ED) care. Risk stratification screening instruments exist to distinguish vulnerable subsets, but their prognostic accuracy varies. This systematic review quantifies the prognostic accuracy of individual risk factors and ED-validated screening instruments to distinguish patients more or less likely to experience short-term adverse outcomes like unanticipated ED returns, hospital readmissions, functional decline, or death. A medical librarian and two emergency physicians conducted a medical literature search of PubMed, EMBASE, SCOPUS, CENTRAL, and ClinicalTrials.gov using numerous combinations of search terms, including emergency medical services, risk stratification, geriatric, and multiple related MeSH terms in hundreds of combinations. Two authors hand-searched relevant specialty society research abstracts. Two physicians independently reviewed all abstracts and used the revised Quality Assessment of Diagnostic Accuracy Studies instrument to assess individual study quality. When two or more qualitatively similar studies were identified, meta-analysis was conducted using Meta-DiSc software. Primary outcomes were sensitivity, specificity, positive likelihood ratio (LR+), and negative likelihood ratio (LR-) for predictors of adverse outcomes at 1 to 12 months after the ED encounters. A hypothetical test-treatment threshold analysis was constructed based on the meta-analytic summary estimate of prognostic accuracy for one outcome. A total of 7,940 unique citations were identified yielding 34 studies for inclusion in this systematic review. Studies were significantly heterogeneous in terms of country, outcomes assessed, and the timing of post-ED outcome assessments. All studies occurred in ED settings and none used published clinical decision rule derivation methodology. Individual risk factors assessed included dementia, delirium, age, dependency, malnutrition, pressure sore risk, and self-rated health. None of these risk factors significantly increased the risk of adverse outcome (LR+ range = 0.78 to 2.84). The absence of dependency reduces the risk of 1-year mortality (LR- = 0.27) and nursing home placement (LR- = 0.27). Five constructs of frailty were evaluated, but none increased or decreased the risk of adverse outcome. Three instruments were evaluated in the meta-analysis: Identification of Seniors at Risk, Triage Risk Screening Tool, and Variables Indicative of Placement Risk. None of these instruments significantly increased (LR+ range for various outcomes = 0.98 to 1.40) or decreased (LR- range = 0.53 to 1.11) the risk of adverse outcomes. The test threshold for 3-month functional decline based on the most accurate instrument was 42%, and the treatment threshold was 61%. Risk stratification of geriatric adults following ED care is limited by the lack of pragmatic, accurate, and reliable instruments. Although absence of dependency reduces the risk of 1-year mortality, no individual risk factor, frailty construct, or risk assessment instrument accurately predicts risk of adverse outcomes in older ED patients. Existing instruments designed to risk stratify older ED patients do not accurately distinguish high- or low-risk subsets. Clinicians, educators, and policy-makers should not use these instruments as valid predictors of post-ED adverse outcomes. Future research to derive and validate feasible ED instruments to distinguish vulnerable elders should employ published decision instrument methods and examine the contributions of alternative variables, such as health literacy and dementia, which often remain clinically occult. © 2014 by the Society for Academic Emergency Medicine.

Do Changes in Patellofemoral Joint Offset Lead to Adverse Outcomes in Total Knee Arthroplasty With Patellar Resurfacing? A Radiographic Review.

PubMed

Matz, Jacob; Howard, James L; Morden, David J; MacDonald, Steven J; Teeter, Matthew G; Lanting, Brent A

2017-03-01

Patellofemoral joint biomechanics contribute to anterior knee pain, instability, and dysfunction following total knee arthroplasty (TKA). Information about specific factors leading to anterior knee pain and dysfunction is currently limited. Changes in patellofemoral joint offset (PFO) refers to a mismatch between the preoperative and postoperative anteroposterior geometry of the patellofemoral joint. It remains unclear whether these changes lead to adverse outcomes in TKA. A retrospective radiographic review of 970 knees pre-TKA and post-TKA was completed to correlate the radiographic and clinical outcomes of changing the PFO using a posterior-stabilized single knee design with patellar resurfacing. A total of 970 patients were reviewed. Postoperatively, the anterior femoral offset, anteroposterior femoral size, and anterior patellar offset were changed in 40%, 60%, and 71% of knees, respectively, compared to preoperative values. The Western Ontario and McMasters Osteoarthritis Index total score as well as subscale scores for pain and function were not significantly affected by an increase or decrease in PFO. Similarly, Knee Society Scores and range of motion were not significantly affected. Increased anterior patellar offset was, however, associated with increased postoperative patellar tilt. Postoperative patellar tilt was not correlated with adverse patient satisfaction scores or loss of range of motion. Changes in PFO (decreased, maintained, or increased) are common post-TKA and are not associated with a difference in clinical outcomes. Increases in anterior patellar offset led to increased patellar tilt, which was not associated with adverse patient satisfaction scores. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparative tolerability of treatments for acute migraine: A network meta-analysis.

PubMed

Thorlund, Kristian; Toor, Kabirraaj; Wu, Ping; Chan, Keith; Druyts, Eric; Ramos, Elodie; Bhambri, Rahul; Donnet, Anne; Stark, Richard; Goadsby, Peter J

2017-09-01

Introduction Migraine headache is a neurological disorder whose attacks are associated with nausea, vomiting, photophobia and phonophobia. Treatments for migraine aim to either prevent attacks before they have started or relieve attacks (abort) after onset of symptoms and range from complementary therapies to pharmacological interventions. A number of treatment-related adverse events such as somnolence, fatigue, and chest discomfort have previously been reported in association with triptans. The comparative tolerability of available agents for the abortive treatment of migraine attacks has not yet been systematically reviewed and quantified. Methods We performed a systematic literature review and Bayesian network meta-analysis for comparative tolerability of treatments for migraine. The literature search targeted all randomized controlled trials evaluating oral abortive treatments for acute migraine over a range of available doses in adults. The primary outcomes of interest were any adverse event, treatment-related adverse events, and serious adverse events. Secondary outcomes were fatigue, dizziness, chest discomfort, somnolence, nausea, and vomiting. Results Our search yielded 141 trials covering 15 distinct treatments. Of the triptans, sumatriptan, eletriptan, rizatriptan, zolmitriptan, and the combination treatment of sumatriptan and naproxen were associated with a statistically significant increase in odds of any adverse event or a treatment-related adverse event occurring compared with placebo. Of the non-triptans, only acetaminophen was associated with a statistically significant increase in odds of an adverse event occurring when compared with placebo. Overall, triptans were not associated with increased odds of serious adverse events occurring and the same was the case for non-triptans. For the secondary outcomes, with the exception of vomiting, all triptans except for almotriptan and frovatriptan were significantly associated with increased risk for all outcomes. Almotriptan was significantly associated with an increased risk of vomiting, whereas all other triptans yielded non-significant lower odds compared with placebo. Generally, the non-triptans were not associated with decreased tolerability for the secondary outcomes. Discussion In summary, triptans were associated with higher odds of any adverse event or a treatment-related adverse event occurring when compared to placebo and non-triptans. Non-significant results for non-triptans indicate that these treatments are comparable with one another and placebo regarding tolerability outcomes.

The household food insecurity gradient and potential reductions in adverse population mental health outcomes in Canadian adults.

PubMed

Jessiman-Perreault, Geneviève; McIntyre, Lynn

2017-12-01

Household food insecurity is related to poor mental health. This study examines whether the level of household food insecurity is associated with a gradient in the risk of reporting six adverse mental health outcomes. This study further quantifies the mental health impact if severe food insecurity, the extreme of the risk continuum, were eliminated in Canada. Using a pooled sample of the Canadian Community Health Survey (N = 302,683), we examined the relationship between level of food insecurity, in adults 18-64 years, and reporting six adverse mental health outcomes. We conducted a probit analysis adjusted for multi-variable models, to calculate the reduction in the odds of reporting mental health outcomes that might accrue from the elimination of severe food insecurity. Controlling for various demographic and socioeconomic covariates, a food insecurity gradient was found in six mental health outcomes. We calculated that a decrease between 8.1% and 16.0% in the reporting of these mental health outcomes would accrue if those who are currently severely food insecure became food secure, after controlling for covariates. Household food insecurity has a pervasive graded negative effect on a variety of mental health outcomes, in which significantly higher levels of food insecurity are associated with a higher risk of adverse mental health outcomes. Reduction of food insecurity, particularly at the severe level, is a public health concern and a modifiable structural determinant of health worthy of macro-level policy intervention.

Direct comparison of risk-adjusted and non-risk-adjusted CUSUM analyses of coronary artery bypass surgery outcomes.

PubMed

Novick, Richard J; Fox, Stephanie A; Stitt, Larry W; Forbes, Thomas L; Steiner, Stefan

2006-08-01

We previously applied non-risk-adjusted cumulative sum methods to analyze coronary bypass outcomes. The objective of this study was to assess the incremental advantage of risk-adjusted cumulative sum methods in this setting. Prospective data were collected in 793 consecutive patients who underwent coronary bypass grafting performed by a single surgeon during a period of 5 years. The composite occurrence of an "adverse outcome" included mortality or any of 10 major complications. An institutional logistic regression model for adverse outcome was developed by using 2608 contemporaneous patients undergoing coronary bypass. The predicted risk of adverse outcome in each of the surgeon's 793 patients was then calculated. A risk-adjusted cumulative sum curve was then generated after specifying control limits and odds ratio. This risk-adjusted curve was compared with the non-risk-adjusted cumulative sum curve, and the clinical significance of this difference was assessed. The surgeon's adverse outcome rate was 96 of 793 (12.1%) versus 270 of 1815 (14.9%) for all the other institution's surgeons combined (P = .06). The non-risk-adjusted curve reached below the lower control limit, signifying excellent outcomes between cases 164 and 313, 323 and 407, and 667 and 793, but transgressed the upper limit between cases 461 and 478. The risk-adjusted cumulative sum curve never transgressed the upper control limit, signifying that cases preceding and including 461 to 478 were at an increased predicted risk. Furthermore, if the risk-adjusted cumulative sum curve was reset to zero whenever a control limit was reached, it still signaled a decrease in adverse outcome at 166, 653, and 782 cases. Risk-adjusted cumulative sum techniques provide incremental advantages over non-risk-adjusted methods by not signaling a decrement in performance when preoperative patient risk is high.

The Balance Between Stress and Personal Capital during Pregnancy and the Relationship with Adverse Obstetric Outcomes: Findings from the 2007 Los Angeles Mommy and Baby (LAMB) Study

PubMed Central

Wakeel, Fathima; Wisk, Lauren E.; Gee, Rebekah; Chao, Shin M.; Witt, Whitney P.

2013-01-01

Purpose Stress during pregnancy is a salient risk factor for adverse obstetric outcomes. Personal capital during pregnancy, defined as internal and social resources that help women cope with or decrease their exposure to stress, may reduce the risk of poor obstetric outcomes. Methods Using data from the 2007 Los Angeles Mommy and Baby (LAMB) survey (N=3,353), we examined the relationships between the balance of stress and personal capital during pregnancy, or the Stress-to-Capital Ratio (SCR), and adverse obstetric outcomes ((i.e., pregnancy complications, preterm birth (PTB), low birthweight (LBW), and small-for-gestational-age (SGA)). Results Women with a higher SCR (i.e. greater stress relative to personal capital during pregnancy) were significantly more likely to experience at least one pregnancy complication, PTB, and lower gestational age, but not LBW or SGA. Accounting for pregnancy complications completely mediated the association between the SCR and PTB. Conclusions Our findings indicate that experiencing greater stress relative to personal capital during pregnancy is associated with an increased risk for pregnancy complications, PTB, and lower gestational age and that pregnancy complications may be a mechanism by which the SCR is related to adverse obstetric outcomes. PMID:23812738

A perinatal care quality and safety initiative: are there financial rewards for improved quality?

PubMed

Kozhimannil, Katy B; Sommerness, Samantha A; Rauk, Phillip; Gams, Rebecca; Hirt, Charles; Davis, Stanley; Miller, Kristi K; Landers, Daniel V

2013-08-01

Although costs of providing care may decrease with hospital initiatives to improve obstetric and neonatal outcomes, the accompanying reduced adverse outcomes may negatively affect hospital revenues. In 2008 a Minnesota-based hospital system (Fairview Health Services) launched the Zero Birth Injury (ZBI) initiative, which used evidence-based care bundles to guide management of obstetric services. A pre-post analysis of financial impacts of ZBI was conducted by using hospital administrative records to measure costs and revenues associated with changes in maternal and neonatal birth injuries before (2008) and after (2009-2011) the initiative. For the Fairview Health Services hospitals, after adjusting for relevant covariates, implementation of ZBI was associated with a mean 11% decrease in the rate of maternal and neonatal adverse outcomes between 2008 and 2011 (adjusted odds ratio [AOR] = 0.89, p = .076). As a result of the adverse events avoided, the hospital system saved $284,985 in costs but earned $324,333 less revenue, which produced a net financial decrease of $39,348 (or a $305 net financial loss per adverse event avoided) in 2011, compared with 2008. Adoption of a perinatal quality and safety initiative that reduced birth injuries had little net financial impact on the hospital. ZBI produced better clinical results at a lower cost, which represents potential savings for payers, but the hospital system offering improved quality reaped no clear financial rewards. These results highlight the important role for shared-savings collaborations (among patients, providers, government and third-party payers, and employers) to incentivize QI. Widespread adoption of perinatal safety initiatives combined with innovative payment models may contribute to better health at reduced cost.

Anorexia of Aging: Assessment and Management.

PubMed

Landi, Francesco; Picca, Anna; Calvani, Riccardo; Marzetti, Emanuele

2017-08-01

Older people often experience loss of appetite and/or decreased food intake that, unavoidably, impact energy metabolism and overall health status. The association of age-related nutritional deficits with several adverse outcomes has led to the recognition of a geriatric condition referred to as "anorexia of aging." Anorexia is an independent predictor of morbidity and mortality both in the community and across clinical settings. Multidimensional interventions within personalized care plans currently represent the most effective option to ensure the provision of adequate amounts of food, limit weight loss, and prevent adverse health outcomes in older adults. Copyright © 2017 Elsevier Inc. All rights reserved.

Associations of Meteorology with Adverse Pregnancy Outcomes: A Systematic Review of Preeclampsia, Preterm Birth and Birth Weight

PubMed Central

Beltran, Alyssa J.; Wu, Jun; Laurent, Olivier

2013-01-01

The relationships between meteorology and pregnancy outcomes are not well known. This article reviews available evidence on the relationships between seasonality or meteorology and three major pregnancy outcomes: the hypertensive disorders of pregnancy (including preeclampsia, eclampsia and gestational hypertension), gestational length and birth weight. In total 35, 28 and 27 studies were identified for each of these outcomes. The risks of preeclampsia appear higher for women with conception during the warmest months, and delivery in the coldest months of the year. Delivery in the coldest months is also associated with a higher eclampsia risk. Patterns of decreased gestational lengths have been observed for births in winter, as well as summer months. Most analytical studies also report decreases in gestational lengths associated with heat. Birth weights are lower for deliveries occurring in winter and in summer months. Only a limited number of studies have investigated the effects of barometric pressure on gestational length or the effects of temperature and sunshine exposure on birth weight, but these questions appear worth investigating further. Available results should encourage further etiological research aiming at enhancing our understanding of the relationships between meteorology and adverse pregnancy outcomes, ideally via harmonized multicentric studies. PMID:24362545

Associations of meteorology with adverse pregnancy outcomes: a systematic review of preeclampsia, preterm birth and birth weight.

PubMed

Beltran, Alyssa J; Wu, Jun; Laurent, Olivier

2013-12-20

The relationships between meteorology and pregnancy outcomes are not well known. This article reviews available evidence on the relationships between seasonality or meteorology and three major pregnancy outcomes: the hypertensive disorders of pregnancy (including preeclampsia, eclampsia and gestational hypertension), gestational length and birth weight. In total 35, 28 and 27 studies were identified for each of these outcomes. The risks of preeclampsia appear higher for women with conception during the warmest months, and delivery in the coldest months of the year. Delivery in the coldest months is also associated with a higher eclampsia risk. Patterns of decreased gestational lengths have been observed for births in winter, as well as summer months. Most analytical studies also report decreases in gestational lengths associated with heat. Birth weights are lower for deliveries occurring in winter and in summer months. Only a limited number of studies have investigated the effects of barometric pressure on gestational length or the effects of temperature and sunshine exposure on birth weight, but these questions appear worth investigating further. Available results should encourage further etiological research aiming at enhancing our understanding of the relationships between meteorology and adverse pregnancy outcomes, ideally via harmonized multicentric studies.

Systolic blood pressure reduction during the first 24 h in acute heart failure admission: friend or foe?

PubMed

Cotter, Gad; Metra, Marco; Davison, Beth A; Jondeau, Guillaume; Cleland, John G F; Bourge, Robert C; Milo, Olga; O'Connor, Christopher M; Parker, John D; Torre-Amione, Guillermo; van Veldhuisen, Dirk J; Kobrin, Isaac; Rainisio, Maurizio; Senger, Stefanie; Edwards, Christopher; McMurray, John J V; Teerlink, John R

2018-02-01

Changes in systolic blood pressure (SBP) during an admission for acute heart failure (AHF), especially those leading to hypotension, have been suggested to increase the risk for adverse outcomes. We analysed associations of SBP decrease during the first 24 h from randomization with serum creatinine changes at the last time-point available (72 h), using linear regression, and with 30- and 180-day outcomes, using Cox regression, in 1257 patients in the VERITAS study. After multivariable adjustment for baseline SBP, greater SBP decrease at 24 h from randomization was associated with greater creatinine increase at 72 h and greater risk for 30-day all-cause death, worsening heart failure (HF) or HF readmission. The hazard ratio (HR) for each 1 mmHg decrease in SBP at 24 h for 30-day death, worsening HF or HF rehospitalization was 1.01 [95% confidence interval (CI) 1.00-1.02; P = 0.021]. Similarly, the HR for each 1 mmHg decrease in SBP at 24 h for 180-day all-cause mortality was 1.01 (95% CI 1.00-1.03; P = 0.038). The associations between SBP decrease and outcomes did not differ by tezosentan treatment group, although tezosentan treatment was associated with a greater SBP decrease at 24 h. In the current post hoc analysis, SBP decrease during the first 24 h was associated with increased renal impairment and adverse outcomes at 30 and 180 days. Caution, with special attention to blood pressure monitoring, should be exercised when vasodilating agents are given to AHF patients. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

Improving Interdisciplinary Provider Communication Through a Unified Paging System.

PubMed

Heidemann, Lauren; Petrilli, Christopher; Gupta, Ashwin; Campbell, Ian; Thompson, Maureen; Cinti, Sandro; Stewart, David A

2016-06-01

Interdisciplinary communication at a Veterans Affairs (VA) academic teaching hospital is largely dependent on alphanumeric paging, which has limitations as a result of one-way communication and lack of reliable physician identification. Adverse patient outcomes related to difficulty contacting the correct consulting provider in a timely manner have been reported. House officers were surveyed on the level of satisfaction with the current VA communication system and the rate of perceived adverse patient outcomes caused by potential delays within this system. Respondents were then asked to identify the ideal paging system. These results were used to develop and deploy a new Web site. A postimplementation survey was repeated 1 year later. This study was conducted as a quality improvement project. House officer satisfaction with the preintervention system was 3%. The majority used more than four modalities to identify consultants, with 59% stating that word of mouth was a typical source. The preferred mode of paging was the university hospital paging system, a Web-based program that is used at the partnering academic institution. Following integration of VA consulting services within the university hospital paging system, the level of satisfaction improved to 87%. Significant decreases were seen in perceived adverse patient outcomes (from 16% to 2%), delays in patient care (from 90% to 16%), and extended hospitalizations (from 46% to 4%). Our study demonstrates significant improvement in physician satisfaction with a newly implemented paging system that was associated with a decreased perceived number of adverse patient events and delays in care.

Changes in Brain Metabolite Concentrations after Neonatal Hypoxic-ischemic Encephalopathy.

PubMed

Shibasaki, Jun; Aida, Noriko; Morisaki, Naho; Tomiyasu, Moyoko; Nishi, Yuri; Toyoshima, Katsuaki

2018-06-12

Purpose To investigate the time-course changes and predictive utility of brain metabolite concentrations in neonatal hypoxic-ischemic encephalopathy (HIE). Materials and Methods Sixty-eight neonates (age, 35-41 gestational weeks) with HIE were admitted to a neonatal intensive care unit between September 2009 and March 2016 and examined by using proton MR spectroscopy at 18-96 hours (n = 25) and 7-14 days (n = 64) after birth (35-43 postmenstrual weeks) to estimate metabolite concentrations in the deep gray matter. Adverse outcome was defined as death or neurodevelopmental impairment at 18-22 months of age. Areas under the receiver operating characteristic curves were calculated to evaluate the prognostic values of metabolites. Results At 18-96 hours, N-acetylaspartate and creatine concentrations were lower, whereas lactate, and glutamate and glutamine (Glx) concentrations were higher in neonates with adverse outcomes than in those with favorable outcomes. Metabolite concentrations at 18-96 hours decreased during days 7-14 in neonates with adverse outcomes but did not change in those with favorable outcomes. For N-acetylaspartate, creatine, lactate, and Glx concentrations measured at 18-96 hours to predict adverse outcomes, areas under the receiver operating characteristic curve were 0.98, 0.89, 0.96, and 0.88, respectively, whereas at 7-14 days, the areas under the receiver operating characteristic curve were 0.97, 0.97, 0.59, and 0.36, respectively. Conclusion Time-dependent reductions in N-acetylaspartate and creatine concentrations at both 18-96 hours and 7-14 days accurately predicted adverse outcomes. However, higher lactate and glutamate and glutamine concentrations were often transient. © RSNA, 2018 Online supplemental material is available for this article.

Quantitative Adverse Outcome Pathways and Their ...

EPA Pesticide Factsheets

A quantitative adverse outcome pathway (qAOP) consists of one or more biologically based, computational models describing key event relationships linking a molecular initiating event (MIE) to an adverse outcome. A qAOP provides quantitative, dose–response, and time-course predictions that can support regulatory decision-making. Herein we describe several facets of qAOPs, including (a) motivation for development, (b) technical considerations, (c) evaluation of confidence, and (d) potential applications. The qAOP used as an illustrative example for these points describes the linkage between inhibition of cytochrome P450 19A aromatase (the MIE) and population-level decreases in the fathead minnow (FHM; Pimephales promelas). The qAOP consists of three linked computational models for the following: (a) the hypothalamic-pitutitary-gonadal axis in female FHMs, where aromatase inhibition decreases the conversion of testosterone to 17β-estradiol (E2), thereby reducing E2-dependent vitellogenin (VTG; egg yolk protein precursor) synthesis, (b) VTG-dependent egg development and spawning (fecundity), and (c) fecundity-dependent population trajectory. While development of the example qAOP was based on experiments with FHMs exposed to the aromatase inhibitor fadrozole, we also show how a toxic equivalence (TEQ) calculation allows use of the qAOP to predict effects of another, untested aromatase inhibitor, iprodione. While qAOP development can be resource-intensive, the quan

Revolutionizing Toxicity Testing For Predicting Developmental Outcomes (DNT4)

EPA Science Inventory

Characterizing risk from environmental chemical exposure currently requires extensive animal testing; however, alternative approaches are being researched to increase throughput of chemicals screened, decrease reliance on animal testing, and improve accuracy in predicting adverse...

Effect of transformational leadership on job satisfaction and patient safety outcomes.

PubMed

Boamah, Sheila A; Spence Laschinger, Heather K; Wong, Carol; Clarke, Sean

Improving patient safety within health care organizations requires effective leadership at all levels. The objective of this study was to investigate the effects of nurse managers' transformational leadership behaviors on job satisfaction and patient safety outcomes. A random sample of acute care nurses in Ontario (N = 378) completed the crosssectional survey. Hypothesized model was tested using structural equation modeling. The model fit the data acceptably. Transformational leadership had a strong positive influence on workplace empowerment, which in turn increased nurses' job satisfaction and decreased the frequency of adverse patient outcomes. Subsequently, job satisfaction was related to lower adverse events. The findings provide support for managers' use of transformational leadership behaviors as a useful strategy in creating workplace conditions that promote better safety outcomes for patients and nurses. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of a quality program with adverse events identification on airway management during overtube-assisted enteroscopy.

PubMed

Lara, Luis F; Ukleja, Andrew; Pimentel, Ronnie; Charles, Roger J

2014-11-01

Adverse events associated with overtube-assisted enteroscopy are similar to those with routine endoscopy. Our endoscopy quality program identified a number of respiratory adverse events resulting in emergency resuscitation efforts. The aim is to report all adverse events identified by quality monitoring and outcomes of adverse events associated with overtube-assisted enteroscopy. A retrospective study used data prospectively obtained from consecutive patients undergoing overtube-assisted enteroscopy between December 2008 and July 2012. Patient characteristics, medical history, procedure indication, and procedure outcomes, including diagnosis, endoscopic therapy, and complications, were obtained. In 432 overtube-assisted enteroscopies, 15 adverse events (most frequently hypoxemia, 9 /15, 60 %) occurred in 14 patients (3.2 % of total cohort; 12 were outpatients) mostly during antegrade enteroscopy. Four patients required endotracheal intubation and 4 /12 outpatients required intensive care. The procedure was aborted in 13 /14 patients, and only 1 of 10 patients scheduled for repeat antegrade enteroscopy returned. There was no mortality. Based on the frequency of adverse events, and in consultation with anesthesia providers, from August 2012 all antegrade overtube-assisted enteroscopies at our institution were done with general anesthesia. From then till September 2013, 145 antegrade and 52 retrograde overtube-assisted enteroscopies have been done, with no adverse events. Monitoring of endoscopy practice identified adverse events associated with overtube-assisted enteroscopy. The peer-review prompted a change in practice: all patients undergoing antegrade overtube-assisted enteroscopy at our institution now have endotracheal intubation which has dramatically decreased the rate of respiratory adverse events. The impact of endoscopic quality measurements on practices, procedures, and outcomes will be of further interest. © Georg Thieme Verlag KG Stuttgart · New York.

Pharmacological Strategies to Counteract Antipsychotic-Induced Weight Gain and Metabolic Adverse Effects in Schizophrenia: A Systematic Review and Meta-analysis

PubMed Central

Mizuno, Yuya; Suzuki, Takefumi; Nakagawa, Atsuo; Yoshida, Kazunari; Mimura, Masaru; Fleischhacker, Walter Wolfgang; Uchida, Hiroyuki

2014-01-01

Background: Antipsychotic-induced metabolic adversities are often difficult to manage. Using concomitant medications to counteract these adversities may be a rational option. Objective: To systematically determine the effectiveness of medications to counteract antipsychotic-induced metabolic adversities in patients with schizophrenia. Data Sources: Published articles until November 2013 were searched using 5 electronic databases. Clinical trial registries were searched for unpublished trials. Study Selection: Double-blind randomized placebo-controlled trials focusing on patients with schizophrenia were included if they evaluated the effects of concomitant medications on antipsychotic-induced metabolic adversities as a primary outcome. Data Extraction: Variables relating to participants, interventions, comparisons, outcomes, and study design were extracted. The primary outcome was change in body weight. Secondary outcomes included clinically relevant weight change, fasting glucose, hemoglobin A1c, fasting insulin, insulin resistance, cholesterol, and triglycerides. Data Synthesis: Forty trials representing 19 unique interventions were included in this meta-analysis. Metformin was the most extensively studied drug in regard to body weight, the mean difference amounting to −3.17 kg (95% CI: −4.44 to −1.90 kg) compared to placebo. Pooled effects for topiramate, sibutramine, aripiprazole, and reboxetine were also different from placebo. Furthermore, metformin and rosiglitazone improved insulin resistance, while aripiprazole, metformin, and sibutramine decreased blood lipids. Conclusion: When nonpharmacological strategies alone are insufficient, and switching antipsychotics to relatively weight-neutral agents is not feasible, the literature supports the use of concomitant metformin as first choice among pharmacological interventions to counteract antipsychotic-induced weight gain and other metabolic adversities in schizophrenia. PMID:24636967

[Adverse pregnancy outcomes after Assisted Reproduction Technology in women with endometriosis].

PubMed

Carassou-Maillan, A; Pouly, J-L; Mulliez, A; Dejou-Bouillet, L; Gremeau, A-S; Brugnon, F; Janny, L; Canis, M

2014-04-01

While association between endometriosis and infertility is well established, there are few studies about the impact of endometriosis on adverse pregnancy outcomes. The aim of this study was to determine the effect of endometriosis on obstetric outcomes and whether the severity of the disease had an influence on these. We performed a retrospective study to investigate the obstetric outcomes of a population of 1204 subfertile women, including 258 with endometriosis, who obtained, thanks to assisted reproduction technology, a singleton pregnancy evolving beyond embryonic stage. Two analyzes were performed. The first compared women with endometriosis to women with other causes of infertility. The second observed adverse pregnancy outcomes according to AFS-R stages of endometriosis. The overall rate of live birth children was 95.8%. In case of endometriosis, there was a significant increase of the incidence of preterm delivery, especially before 32 weeks amenorrhea (6.2% vs 3.1% in the group "without endometriosis", P = 0.03), antenatal bleeding (5.3% vs 2.2%, P = 0.01) and placenta previa (4.9% vs 0.9%, P < 0.0001). The incidence of gestational diabetes was significantly decreased (0.4% vs 2.7%, P = 0.04). There was no correlation between endometriosis and cesarean section or preeclampsia, or between the AFS-R stage and adverse pregnancy outcomes. Endometriosis is a factor of obstetrical risk, independently of the infertility it causes. The AFS-R score does not seem to be representative of obstetric outcomes beyond first trimester of pregnancy for women with endometriosis. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Temporal Trends in Anesthesia-related Adverse Events in Cesarean Deliveries, New York State, 2003-2012.

PubMed

Guglielminotti, Jean; Wong, Cynthia A; Landau, Ruth; Li, Guohua

2015-11-01

Cesarean delivery (CD) is associated with significantly increased risks of anesthesia-related adverse events (ARAEs) and nonanesthetic perioperative morbidity compared with vaginal delivery. Temporal trends in these adverse outcomes remain unknown despite efforts to improve maternal safety. This study examines temporal trends in ARAEs and nonanesthetic perioperative complications in CDs in New York hospitals. Data are from the State Inpatient Database for New York, 2003-2012. ARAEs, including minor and major ARAEs, and nonanesthetic perioperative complications were identified through International Classification of Diseases, Ninth Revision, Clinical Modification codes. Statistical significance in time trends was assessed using the Cochran-Armitage test and multivariable logistic regression. Of the 785,854 CDs studied, 5,715 (730 per 100,000; 95% CI, 710 to 750) had at least one ARAE and 7,040 had at least one perioperative complication (890 per 100,000; 95% CI, 870 to 920). The overall annual rate of ARAEs decreased from 890 per 100,000 in 2003 to 660 in 2012 (25% decrease; 95% CI, 16 to 34; P < 0.0001). The rate of minor ARAEs decreased 23% (95% CI, 13 to 32) and of major ARAEs decreased 43% (95% CI, 23 to 63). No decrease was observed in the rate of ARAEs for CDs performed under general anesthesia. The rate of nonanesthetic complications increased 47% (95% CI, 31 to 63; P < 0.0001). Anesthesia-related outcomes in cesarean deliveries appear to have improved significantly across hospitals in New York in the past decade. Perioperative nonanesthetic complications remain a serious healthcare issue.

Associations between childhood body size and seventeen adverse outcomes: analysis of 65,057 European women.

PubMed

Li, Jingmei; Eriksson, Mikael; He, Wei; Hall, Per; Czene, Kamila

2017-12-05

Large childhood body size has been consistently shown to be associated with decreased breast cancer risk. However, it is important to consider the effects of a large childhood body size on other adult diseases. It is not clear if the associations between childhood body size and adult diseases will persist if they later attain healthy weight. The associations between body size at age 7 and 17 adverse outcomes in adulthood were examined using Cox models in a Swedish study of 65,057 women. Large body size at age 7, when compared to small body size, was associated with decreased risk for breast cancer (HR [95% CI]: 0.81 [0.70-0.93]) and increased risks for anorexia (2.13 [1.63-2.77]) and bulimia (1.91 [1.35-2.70]). Neither adjusting for adult BMI nor restricting the dataset to lean adults (BMI < 25 kg/m 2 ) attenuated the associations. While large body size at age 7 by itself was positively associated with increased risks of diabetes (1.34 [1.16-1.55]), PCOS (1.69 [1.13-2.51]) and hypertension (before age 60), the associations were no longer significant after controlling for adult BMI. No clear associations were found with the remaining adverse outcomes (cervical, uterine, melanoma, colon cancer, depression, ovarian cyst, stroke, hyperlipidemia, heart failure, myocardial infarction, and angina pectoris).

Global burden of maternal and congenital syphilis in 2008 and 2012: a health systems modelling study.

PubMed

Wijesooriya, N Saman; Rochat, Roger W; Kamb, Mary L; Turlapati, Prasad; Temmerman, Marleen; Broutet, Nathalie; Newman, Lori M

2016-08-01

In 2007, WHO launched a global initiative for the elimination of mother-to-child transmission of syphilis (congenital syphilis). An important aspect of the initiative is strengthening surveillance to monitor progress towards elimination. In 2008, using a health systems model with country data inputs, WHO estimated that 1·4 million maternal syphilis infections caused 520 000 adverse pregnancy outcomes. To assess progress, we updated the 2008 estimates and estimated the 2012 global prevalence and cases of maternal and congenital syphilis. We used a health systems model approved by the Child Health Epidemiology Reference Group. WHO and UN databases provided inputs on livebirths, antenatal care coverage, and syphilis testing, seropositivity, and treatment in antenatal care. For 2012 estimates, we used data collected between 2009 and 2012. We updated the 2008 estimates using data collected between 2000 and 2008, compared these with 2012 estimates using data collected between 2009 and 2012, and performed subanalyses to validate results. In 2012, an estimated 930 000 maternal syphilis infections caused 350 000 adverse pregnancy outcomes including 143 000 early fetal deaths and stillbirths, 62 000 neonatal deaths, 44 000 preterm or low weight births, and 102 000 infected infants worldwide. Nearly 80% of adverse outcomes (274 000) occurred in women who received antenatal care at least once. Comparing the updated 2008 estimates with the 2012 estimates, maternal syphilis decreased by 38% (from 1 488 394 cases in 2008 to 927 936 cases in 2012) and congenital syphilis decreased by 39% (from 576 784 to 350 915). India represented 65% of the decrease. Analysis excluding India still showed an 18% decrease in maternal and congenital cases of syphilis worldwide. Maternal and congenital syphilis decreased worldwide from 2008 to 2012, which suggests progress towards the elimination of mother-to-child transmission of syphilis. Nonetheless, maternal syphilis caused substantial adverse pregnancy outcomes, even in women receiving antenatal care. Improved access to quality antenatal care, including syphilis testing and treatment, and robust data are all important for achieving the elimination of mother-to-child transmission of syphilis. The UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction in WHO, and the US Centers for Disease Control and Prevention. Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND license. Published by Elsevier Ltd.. All rights reserved.

Implementation of an Oxytocin Checklist to Improve Clinical Outcomes.

PubMed

Sundin, Courtney; Mazac, Lauren; Ellis, Kathleen; Garbo, Candon

Oxytocin is one of the most common drugs administered in obstetrics. Since its designation as a high-alert medication by the Institute for Safe Medication Practices in 2007, there has been much attention to oxytocin administration during labor. Oxytocin is generally safe when administered correctly, but adverse perinatal outcomes can occur during uterine tachysystole. The purpose of this project was to evaluate and compare results of maternal and fetal outcomes of induction of labor for women at term prior to and after implementation of a newly developed oxytocin checklist. To evaluate the practice change associated with the implementation of the new oxytocin checklist, 200 cases based on retrospective medical record reviews were compared with 200 cases after implementation. Use of the checklist was associated with several significant clinical outcomes, including decreases in tachysystole, decreases in cesarean births for concern about fetal status based on electronic fetal monitoring data, decreases in length of first stage labor, and decreases in maximum dose of oxytocin. Results are similar to previous research. Early physician buy-in, clinical team education, and ongoing evaluation enhanced facilitation of the oxytocin checklist. Clinical outcomes were favorable.

Childhood sexual abuse and adult developmental outcomes: findings from a 30-year longitudinal study in New Zealand.

PubMed

Fergusson, David M; McLeod, Geraldine F H; Horwood, L John

2013-09-01

Childhood sexual abuse (CSA) has been associated with many adverse medical, psychological, behavioral and socioeconomic outcomes in adulthood. This study aims to examine the linkages between CSA and a wide range of developmental outcomes over a protracted time period to age 30. Data from over 900 members of the New Zealand birth cohort the Christchurch Health and Development Study were examined. CSA prior to age 16 was assessed at ages 18 and 21 years, in addition to: mental health, psychological wellbeing, sexual risk-taking behaviors, physical health and socioeconomic outcomes to age 30. After statistical adjustment for confounding by 10 covariates spanning socio-demographic, family functioning and child factors, extent of exposure to CSA was associated with increased rates of (B, SE, p): major depression (0.426, 0.094, <.001); anxiety disorder (0.364, 0.089, <.001); suicidal ideation (0.395, 0.089, <.001); suicide attempt (1.863, 0.403, <.001); alcohol dependence (0.374, 0.118, <.002); and illicit drug dependence (0.425, 0.113, <.001). In addition, at age 30 CSA was associated with higher rates of PTSD symptoms (0.120, 0.051, .017); decreased self-esteem (-0.371, 0.181, .041); and decreased life satisfaction (-0.510, 0.189, .007). Childhood sexual abuse was also associated with decreased age of onset of sexual activity (-0.381, 0.091, <.001), increased number of sexual partners (0.175, 0.035, <.001); increased medical contacts for physical health problems (0.105, 0.023, <.001); and welfare dependence (0.310, 0.099, .002). Effect sizes (Cohen's d) for the significant outcomes from all domains ranged from .14 to .53, while the attributable risks for the mental health outcomes ranged from 5.7% to 16.6%. CSA is a traumatic childhood life event in which the negative consequences increase with increasing severity of abuse. CSA adversely influences a number of adult developmental outcomes that span: mental disorders, psychological wellbeing, sexual risk-taking, physical health and socioeconomic wellbeing. While the individual effect sizes for CSA typically range from small to moderate, it is clear that accumulative adverse effects on adult developmental outcomes are substantial. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Clinical observation of apatinib mesylate for the treatment of multi-drug resistant advanced breast cancer].

PubMed

Lü, H M; Zhang, M W; Niu, L M; Zeng, H A; Yan, M

2018-04-24

Objective: To assess the clinical efficacy and adverse outcomes of apatinib mesylate for the treatment of multi-drug resistant advanced breast cancer. Methods: A total of 24 patients with multi-drug-resistant advanced breast cancer who underwent apatinib mesylate treatment were retrospectively analyzed at the Diagnosis and Treatment Center for Breast Cancer of Henan Cancer Hospital. Patients were reviewed every 4 weeks after initial treatment and then every 8 weeks after stable disease. Objective response rate (ORR), progression free survival (PFS), overall survival (OS) , toxicity and adverse outcomes of apatinib mesylate treatment were evaluated by imaging examinations. Results: Totally, 24 patients received apatinib mesylate at a dose of 500 mg QD. Out of the 24 patients treated, complete remission (CR) occurred in none of the patients, partial remission (PR) in 10 cases, stable disease (SD) in 10 cases, progressive disease (PD) in 4 cases, and drug with drawal in 2 cases due to adverse outcomes. Treatment with apatinib mesylate resulted in an ORR of 41.7% (10/24), disease control rate (DCR) of 83.3%, PFS of 4.7 months, and OS of 8.0 months. Adverse outcomes included proteinuria, high blood pressure, fatigue, hand-foot skin reaction (HFSR), hyperbilirubinemia, leukopenia, hair/skin pigmentation decreased. Most of the adverse events were tolerable and can be controlled after symptomatic management. Conclusions: Single-agent apatinib mesylate demonstrated the good short-term efficacy for multi-drug resistant advanced breast cancer in patients who previously underwent multiple line treatment failures. Adverse effects were controllable after symptomatic management. Treatment with apatinib mesylate maybe a viable option when other treatment modalities failed.

Linking Nurses' Clinical Leadership to Patient Care Quality: The Role of Transformational Leadership and Workplace Empowerment.

PubMed

Boamah, Sheila

2018-03-01

Background While improving patient safety requires strong nursing leadership, there has been little empirical research that has examined the mechanisms by which leadership influences patient safety outcomes. Aim To test a model examining relationships among transformational leadership, structural empowerment, staff nurse clinical leadership, and nurse-assessed adverse patient outcomes. Methods A cross-sectional survey was conducted with a randomly selected sample of 378 registered nurses working in direct patient care in acute care hospitals across Ontario, Canada. Structural equation modeling was used to test the hypothesized model. Results The model had an acceptable fit, and all paths were significant. Transformational leadership was significantly associated with decreased adverse patient outcomes through structural empowerment and staff nurse clinical leadership. Discussion This study highlights the importance of transformational leadership in creating empowering practice environments that foster high-quality care. The findings indicate that a more complete understanding of what drives desired patient outcomes warrants the need to focus on how to empower nurses and foster clinical leadership practices at the point of care. Conclusion In planning safety strategies, managers must demonstrate transformational leadership behaviors in order to modify the work environment to create better defenses for averting adverse events.

The Association between Psychiatric Comorbidities and Outcomes for Inpatients with Traumatic Brain Injury.

PubMed

Brandel, Michael G; Hirshman, Brian R; McCutcheon, Brandon A; Tringale, Kathryn; Carroll, Kate; Richtand, Neil M; Perry, William; Chen, Clark C; Carter, Bob S

2017-03-01

It is well established that traumatic brain injury (TBI) is associated with the development of psychiatric disorders. However, the impact of psychiatric disorders on TBI outcome is less well understood. We examined the outcomes of patients who experienced a traumatic subdural hemorrhage and whether a comorbid psychiatric disorder was associated with a change in outcome. A retrospective observational study was performed in the California Office of Statewide Health Planning and Development (OSHPD) and the Nationwide Inpatient Sample (NIS). Patients hospitalized for acute subdural hemorrhage were identified using International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes. Patients with coexisting psychiatric diagnoses were identified. Outcomes studied included mortality and adverse discharge disposition. In OSPHD, diagnoses of depression (OR = 0.64, p < 0.001), bipolar disorder (OR = 0.45, p < 0.05), and anxiety (OR = 0.37, p < 0.001) were associated with reduced mortality during hospitalization for TBI, with a trend toward psychosis (OR = 0.56, p = 0.08). Schizophrenia had no effect. Diagnoses of psychosis (OR = 2.12, p < 0.001) and schizophrenia (OR = 2.60, p < 0.001) were associated with increased adverse discharge. Depression and bipolar disorder had no effect, and anxiety was associated with reduced adverse discharge (OR = 0.73, p = 0.01). Results were confirmed using the NIS. Analysis revealed novel associations between coexisting psychiatric diagnoses and TBI outcomes, with some subgroups having decreased mortality and increased adverse discharge. Potential mechanisms include pharmacological effects of frequently prescribed psychiatric medications, the pathophysiology of individual psychiatric disorders, or under-coding of psychiatric illness in the most severely injured patients. Because pharmacological mechanisms, if validated, might lead to improved outcome in TBI patients, further studies may provide significant public health benefit.

Heart rate at first postdischarge visit and outcomes in patients with heart failure.

PubMed

Kim, Tae-Hun; Kim, Hyungseop; Kim, In-Cheol; Yoon, Hyuck-Jun; Park, Hyoung-Seob; Cho, Yun-Kyeong; Nam, Chang-Wook; Han, Seongwook; Hur, Seung-Ho; Kim, Yoon-Nyun

2018-07-01

Heart rate control is important to prevent adverse outcomes in patients with heart failure (HF). However, postdischarge activity may worsen heart rate control, resulting in readmission. This study aimed to explore the implications of the heart rate differences between discharge and the first outpatient visit (D-O diff). We retrospectively identified 458 patients (male: 46%; mean age: 72 years) discharged after HF. The heart rates at admission, discharge and first outpatient visit were analysed. The primary outcome was a composite of cardiovascular (CV) death and readmission of non-fatal myocardial infarction (MI), non-fatal stroke or non-fatal HF over a mean follow-up of 16 months. During follow-up, the clinical outcomes were noted in 223 patients (49%): HF, 199; stroke, 9; MI, 6; CV death, 9. The heart rate at the first outpatient visit (r=-0.311, P<0.001) and D-O diff (r=0.416, P<0.001) showed a better correlation with the time-to-clinical event than the heart rate at admission or discharge. The events group displayed a pronounced heart rate increase (13 beats/min) from discharge to the first outpatient visit compared with the event-free group (a decrease of 2 beats/min). A decrease less than -15 in the D-O diff showed a 4.5-fold risk of clinical outcomes during follow-up (P<0.001). A decreased D-O diff was related to the adverse outcomes of HF. The failure of heart rate control within more than 15 beats/min at the first outpatient visit was an independent factor for CV events. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Constraining Medicare Home Health Reimbursement: What Are the Outcomes?

PubMed Central

McCall, Nelda; Korb, Jodi; Petersons, Andrew; Moore, Stanley

2002-01-01

The implementation of the Balanced Budget Act (BBA) of 1997 resulted in substantial decreases in the amount of Medicare home health use. Use among home health users decreased by two-fifths from fiscal year (FY) 1997, just before the passage of the BBA to FY 1999, the first full year after the implementation of the home health interim payment system. This article examines whether these dramatic reductions in use resulted in increased incidence of potential adverse outcomes, i.e., increases in hospitalizations, skilled nursing home facility admissions, emergency room (ER) use, or death among home health users. PMID:12690695

Factors associated with adverse clinical outcomes among obstetric trainees

PubMed Central

Aiken PhD, Catherine E.; Aiken, Abigail; Park, Hannah; Brockelsby, Jeremy C.; Prentice, Andrew

2016-01-01

Objective To determine whether UK obstetric trainees transitioning from directly to indirectly-supervised practice have a higher likelihood of adverse patient outcomes from operative deliveries compared to other indirectly supervised trainees and to examine whether performing more procedures under direct supervision is associated with fewer adverse outcomes in initial indirect practice. Methods We examined all deliveries (13,861) conducted by obstetricians at a single centre over 5 years (2008-2013). Mixed-effects logistic regression models were used to compare estimated blood loss, maternal trauma, umbilical arterial pH, delayed neonatal respiration, failed instrumental delivery, and critical incidents for trainees in their first indirectly-supervised year with trainees in all other years of indirect practice. Outcomes for trainees in their first indirectly-supervised 3 months were compared to their outcomes for the remainder of the year. Linear regression was used to examine the relationship between number of procedures performed under direct supervision and initial outcomes under indirect supervision. Results Trainees in their first indirectly-supervised year had a higher likelihood of >2 litres estimated blood loss at any delivery (OR 1.32;CI(1.01-1.64) p<0.05) and of failed instrumental delivery (OR 2.33;CI(1.37-3.29) p<0.05) compared with other indirectly-supervised trainees. Other measured outcomes showed no significant differences. Within the first three months of indirect supervision, the likelihood of operative vaginal deliveries with >1litre estimated blood loss (OR 2.54;CI(1.88-3.20) p<0.05) was higher compared to the remainder of the first year. Performing more deliveries under direct supervision prior to beginning indirectly-supervised training was associated with decreased risk of >1litre estimated blood loss (p<0.05). Conclusions Obstetric trainees in their first year of indirectly-supervised practice have a higher likelihood of immediate adverse delivery outcomes, which are primarily maternal rather than neonatal. Undertaking more directly supervised procedures prior to transitioning to indirectly-supervised practice may reduce adverse outcomes, suggesting that experience is a key consideration in obstetric training programme design. PMID:26077215

The importance of declining insulin requirements during pregnancy in patients with pre-gestational gestational diabetes mellitus.

PubMed

Ram, Maya; Feinmesser, Larissa; Shinar, Shiri; Maslovitz, Sharon

2017-08-01

In patients with pre-gestational and gestational diabetes mellitus (GDM), insulin requirements often increase during the third trimester of pregnancy in order to maintain proper glycemic control. However, a fraction of patients demonstrate a significant decrease in insulin requirements in late gestation. We aimed to evaluate the clinical significance of decreasing insulin requirements in patients with pre-gestational diabetes and GDM with respect to fetal wellbeing and pregnancy outcome. We performed a retrospective cohort study in a single referral center for gestational diabetes between 1/2010 and 12/2014. Healthy pregnant women with pre-gestational diabetes and GDMA2 and a decrease of at least 30% in insulin requirements over a period of two weeks during the third trimester (group A) were compared to women with stable or increasing insulin requirements (group B). The primary outcome was a composite of situations associated with feto-placental dysfunction (fetal growth restriction, oligohydramnios and cesarean section due to category 2-3 monitor). Secondary outcomes were maternal oral glucose tolerance test (OGTT) results 6 weeks postpartum, neonatal intensive care unit (NICU) admission rates, Apgar scores ≤7 at 5min, arterial blood pH≤7.1, macrosomia, neonatal hypoglycemia and a composite adverse neonatal outcomes (defined as one or more of the following: respiratory morbidity, cerebral morbidity, phototherapy, need for blood transfusion, necrotizing enterocolitis or death). Group A consisted of 101 women and group B - of 203 women. There were no differences between the groups in demographic characteristics or diagnostic characteristics of diabetes. The frequency of conditions related to feto-placental dysfunction did not differ between the groups (7.9% vs. 8.4%, p=0.61). Secondary outcome measures also did not differ between the groups, regardless of insulin requirements. Decreasing insulin requirements during the third trimester are not associated with adverse perinatal outcome related to placental dysfunction. Copyright © 2017 Elsevier B.V. All rights reserved.

SUPPLEMENTATION WITH VITAMINS C AND E DURING PREGNANCY FOR THE PREVENTION OF PREECLAMPSIA AND OTHER ADVERSE MATERNAL AND PERINATAL OUTCOMES: A SYSTEMATIC REVIEW AND METAANALYSIS

PubMed Central

CONDE-AGUDELO, Agustín; ROMERO, Roberto; KUSANOVIC, Juan Pedro; HASSAN, Sonia

2011-01-01

OBJECTIVE To determine whether supplementation with vitamins C and E during pregnancy reduces the risk of preeclampsia and other adverse maternal and perinatal outcomes. STUDY DESIGN Systematic review and metaanalysis of randomized controlled trials. RESULTS Nine trials involving a total of 19,810 women were included. Overall, there were no significant differences between the vitamin and placebo groups in the risk of preeclampsia (9.6% versus 9.6%; relative risk 1.00, 95% confidence interval 0.92–1.09). Similar results were obtained when subgroup analyses were restricted to women at high risk or low/moderate risk for preeclampsia. Women supplemented with vitamins C and E were at increased risk of developing gestational hypertension and premature rupture of membranes, and a decreased risk of abruptio placentae. There were no significant differences between the vitamin and placebo groups in the risk of other adverse maternal or fetal/perinatal outcomes. CONCLUSION Supplementation with vitamins C and E during pregnancy does not prevent preeclampsia. PMID:21529757

Nursing role model for computed tomography contrast injection decreases extravasation rates.

PubMed

Kadom, Nadja; Hashim, Hayder D; Olsen, Cara; Cefaratti, Marjean; Bulas, Dorothy; Shalaby-Rana, Eglal

2012-04-01

Extravasation of intravenous contrast administered for computed tomography remains of concern in pediatric patients. It is of great interest to any pediatric radiology department to decrease extravasation events in an effort to reduce even small adverse outcomes and improve the overall patient experience in the radiology department. Here, a total of 17 extravasation events, as reported and documented in departmental quality assurance at our institution over 4 years, were retrospectively reviewed for factors contributing to the number of adverse extravasation events. We found that pediatric nursing plays a central role in both achieving and maintaining a low extravasation rate at our institution. Copyright © 2012 Elsevier Inc. All rights reserved.

Pregnancy outcomes in type 2 diabetic patients as compared with type 1 diabetic patients and nondiabetic controls.

PubMed

Knight, Kristin M; Thornburg, Loralei L; Pressman, Eva K

2012-01-01

To characterize the neonatal and maternal outcomes of type 2 diabetic patients as compared with type 1 diabetic patients and nondiabetic controls. We performed a retrospective cohort study reviewing perinatal outcomes of type 1 and type 2 diabetic patients and nondiabetic controls from July 2000 to August 2006. Analysis of variance, t testing and chi2 analysis were used to compare groups. Post hoc power analysis indicated 80% power was necessary to detect a 15% difference in composite poor neonatal outcomes. A total of 64 type 2 and 64 type 1 diabetic patients were compared with 256 controls. Type 1 diabetic patients had higher incidences of composite poor neonatal outcome and congenital anomalies than did type 2 diabetic and control patients. Both diabetic groups had similarly higher incidences of cesarean delivery, preeclampsia, preterm delivery, polyhydramnios and macrosomia than did controls. Type 2 diabetic patients have a decreased incidence of adverse neonatal outcomes when compared with that of type 1 diabetic patients. No difference was observed between the diabetic groups in the incidence of a majority of the adverse maternal outcomes examined, however both diabetic groups had overall worse outcomes that did nondiabetic controls.

Brucellosis in pregnancy: clinical aspects and obstetric outcomes.

PubMed

Vilchez, Gustavo; Espinoza, Miguel; D'Onadio, Guery; Saona, Pedro; Gotuzzo, Eduardo

2015-09-01

Brucellosis is a zoonosis with high morbidity in humans. This disease has gained interest recently due to its re-emergence and potential for weaponization. Pregnant women with this disease can develop severe complications. Its association with adverse obstetric outcomes is not clearly understood. The objective of this study was to describe the obstetric outcomes of brucellosis in pregnancy. Cases of pregnant women with active brucellosis seen at the Hospital Nacional Cayetano Heredia from 1970 to 2012 were reviewed. Diagnostic criteria were a positive agglutination test and/or positive blood/bone marrow culture. Presentation and outcomes data were collected. The Chi-square test was used for nominal variables. A p-value of <0.05 indicated significance. One hundred and one cases were included; 27.7% had a threatened abortion/preterm labor, 12.8% experienced spontaneous abortion, 13.9% preterm delivery, 8.1% fetal death, and 1.1% congenital malformations. There was one maternal death secondary to severe sepsis. After delivery, neonatal death occurred in 8.1%, low birth weight in 14.5%, and congenital brucellosis in 6.4%. The most common treatment was aminoglycosides plus rifampicin (42.2% of cases). Complication rates decreased if treatment was started within 2 weeks of presentation (p < 0.001). This is the largest series of brucellosis in pregnancy reported in the literature. Brucella presents adverse obstetric outcomes including fetal and maternal/neonatal death. Cases with unexplained spontaneous abortion should be investigated for brucellosis. Prompt treatment is paramount to decrease the devastating outcomes. Copyright © 2015. Published by Elsevier Ltd.

Influence of Ebola on tuberculosis case finding and treatment outcomes in Liberia

PubMed Central

Cambell, C. L.; Ade, S.; Bhat, P.; Harries, A. D; Wilkinson, E.; Cooper, C. T.

2017-01-01

Setting: National Leprosy and Tuberculosis (TB) Control Programme, Liberia. Objectives: To assess TB case finding, including human immunodeficiency virus (HIV) associated interventions and treatment outcomes, before (January 2013–March 2014), during (April 2014–June 2015) and after (July–December 2015) the Ebola virus disease outbreak. Design: A cross-sectional study and retrospective cohort analysis of outcomes. Results: The mean quarterly numbers of individuals with presumptive TB and the proportion diagnosed as smear-positive were: pre-Ebola (n = 7032, 12%), Ebola (n = 6147, 10%) and post-Ebola (n = 6795, 8%). For all forms of TB, stratified by category and age group, there was a non-significant decrease in the number of cases from the pre-Ebola to the Ebola and post-Ebola periods. There were significant decreases in numbers of cases with smear-positive pulmonary TB (PTB) from the pre-Ebola period (n = 855), to the Ebola (n = 640, P < 0.001) and post-Ebola (n = 568, P < 0.001) periods. The proportions of patients tested for HIV, found to be HIV-positive and started on antiretroviral therapy decreased as follows: pre-Ebola (respectively 72%, 15% and 34%), Ebola (69%, 14% and 30%) and post-Ebola (68%, 12% and 26%). Treatment success rates among TB patients were: 80% pre-Ebola, 69% Ebola (P < 0.001) and 73% post-Ebola (P < 0.001). Loss to follow-up was the main contributing adverse outcome. Conclusion: The principal negative effects of Ebola were the significant decreases in diagnoses of smear-positive PTB, the declines in HIV testing and antiretroviral therapy uptake and poor treatment success. Ways to prevent these adverse effects from recurring in the event of another Ebola outbreak need to be found. PMID:28744441

Influence of Ebola on tuberculosis case finding and treatment outcomes in Liberia.

PubMed

Konwloh, P K; Cambell, C L; Ade, S; Bhat, P; Harries, A D; Wilkinson, E; Cooper, C T

2017-06-21

Setting: National Leprosy and Tuberculosis (TB) Control Programme, Liberia. Objectives: To assess TB case finding, including human immunodeficiency virus (HIV) associated interventions and treatment outcomes, before (January 2013-March 2014), during (April 2014-June 2015) and after (July-December 2015) the Ebola virus disease outbreak. Design: A cross-sectional study and retrospective cohort analysis of outcomes. Results: The mean quarterly numbers of individuals with presumptive TB and the proportion diagnosed as smear-positive were: pre-Ebola ( n = 7032, 12%), Ebola ( n = 6147, 10%) and post-Ebola ( n = 6795, 8%). For all forms of TB, stratified by category and age group, there was a non-significant decrease in the number of cases from the pre-Ebola to the Ebola and post-Ebola periods. There were significant decreases in numbers of cases with smear-positive pulmonary TB (PTB) from the pre-Ebola period ( n = 855), to the Ebola ( n = 640, P < 0.001) and post-Ebola ( n = 568, P < 0.001) periods. The proportions of patients tested for HIV, found to be HIV-positive and started on antiretroviral therapy decreased as follows: pre-Ebola (respectively 72%, 15% and 34%), Ebola (69%, 14% and 30%) and post-Ebola (68%, 12% and 26%). Treatment success rates among TB patients were: 80% pre-Ebola, 69% Ebola ( P < 0.001) and 73% post-Ebola ( P < 0.001). Loss to follow-up was the main contributing adverse outcome. Conclusion: The principal negative effects of Ebola were the significant decreases in diagnoses of smear-positive PTB, the declines in HIV testing and antiretroviral therapy uptake and poor treatment success. Ways to prevent these adverse effects from recurring in the event of another Ebola outbreak need to be found.

Biofeedback: Making the Science Real

PubMed Central

Baker, Robert A.; Newland, Richard F.; Bennetts, Jayme

2009-01-01

Abstract: Neurological deficits such as stroke and subtle psychological, cognitive, and behavioral changes are known risks associated with cardiac surgery. These altered neurologic outcomes have a significant impact on patients and their quality of life postoperatively. Perioperative events, such as cerebral embolism and decrease in cerebral oxygenation and hypoperfusion have been identified as factors causal in producing adverse neurologic outcomes. More importantly, a number of mechanisms related to operative techniques have been found to cause these adverse events. Identifying practices associated with adverse outcomes and implementing practice changes may benefit clinical outcomes for cardiac surgery patients. Standardizing techniques among clinicians will also achieve continuous quality improvement in the process of care. Optimal intra-operative management systems contribute significantly to ensuring good patient outcomes (i.e., avoiding neurological injury in patients which is an important cause of post-operative morbidity and mortality). Groom and colleagues (2004) have developed a system to obtain a thorough understanding and redesign of the process of care associated with cardiac surgery. They have developed a system that simultaneously measures some embolic activity, cerebral oxygen saturation, and physiologic parameters, as well as uses a video recording device during cardiac surgery. To date, the evaluation of this methodology in a rigorous, prospective manner has not been reported. Our aim is to conduct a randomised clinical trial to evaluate the influence of continuous quality improvement in cardiac surgery using biofeedback (i.e., real time information on physiologic functioning from an integrated monitoring system) to reduce the incidence of potentially adverse events during surgery. By achieving the outcomes of this project, we plan to be able to not only introduce change in our own practice, but provide a framework for other units to introduce change. PMID:20092086

The business case for nursing in long-term care.

PubMed

Horn, Susan D

2008-05-01

Lower nurse staffing in hospitals has been associated with adverse patient outcomes; results in nursing homes (NHs) are less clear. We examined the association between nurses' direct care time and outcomes in long-stay NH residents and potential cost savings from decreased adverse outcomes versus additional wages for adequate nurse staffing. Data were from the National Pressure Ulcer Long-Term Care Study of 1,376 at-risk residents from 82 NHs. Primary data came from medical records. Hospital, pressure ulcer (PrU) treatment, and urinary tract infection (UTI) costs were from national statistics or cost-identification studies. Time horizon was 1 year. More registered nurse (RN) direct care time/resident/day was associated with fewer PrUs, hospitalizations, and UTIs. Annual net societal benefit was $3,191/resident/year in high-risk NH units with 30-40 min of RN time/resident/day versus units with <10 min. Thus, after controlling for important variables, more RN time/day was strongly associated with better outcomes and lower societal cost.

Four trace elements in pregnant women and their relationships with adverse pregnancy outcomes.

PubMed

Shen, P-J; Gong, B; Xu, F-Y; Luo, Y

2015-12-01

Lack of trace elements during pregnancy is detrimental to maternal and fetal health. Our aim is to study the changes in trace element levels in Chinese pregnant women and their association with adverse pregnancy outcomes. 1568 cases of Chinese pregnant women in remote areas were collected for a prospective cohort study. Serum copper, zinc, calcium and iron levels were measured at pre-pregnancy, 1st trimester (7w-12w), 2nd trimester (24w-28w) and 3rd trimester (35w-40w). (1) Serum copper levels was significantly higher after pregnancy than before, calcium and iron levels decreased, but zinc levels did not change significantly. (2) Copper and zinc deficiency in pregnant women was not a common finding, but lack of iron and calcium was frequently encountered; iron deficiency was especially common in the 3rd trimester (42.27%). (3) Serum zinc and iron levels in patients who either had a miscarriage or a preterm delivery were significantly lower than in the control group (p < 0.05). In patients with premature rupture of membranes, serum zinc levels were significantly lower (p < 0.05). In patients with intrauterine growth restriction (IUGR), serum copper, zinc, calcium and iron were significantly lower (p < 0.05). Trace elements is closely associated with fetal growth and development during pregnancy. Deficiency can lead to adverse pregnancy outcomes. Therefore, we should have a reasonable diet, replenish trace elements, therefore reducing the occurrence of adverse pregnancy outcomes.

Integrated Approach to Reduce Perinatal Adverse Events: Standardized Processes, Interdisciplinary Teamwork Training, and Performance Feedback.

PubMed

Riley, William; Begun, James W; Meredith, Les; Miller, Kristi K; Connolly, Kathy; Price, Rebecca; Muri, Janet H; McCullough, Mac; Davis, Stanley

2016-12-01

To improve safety practices and reduce adverse events in perinatal units of acute care hospitals. Primary data collected from perinatal units of 14 hospitals participating in the intervention between 2008 and 2012. Baseline secondary data collected from the same hospitals between 2006 and 2007. A prospective study involving 342,754 deliveries was conducted using a quality improvement collaborative that supported three primary interventions. Primary measures include adoption of three standardized care processes and four measures of outcomes. Chart audits were conducted to measure the implementation of standardized care processes. Outcome measures were collected and validated by the National Perinatal Information Center. The hospital perinatal units increased use of all three care processes, raising consolidated overall use from 38 to 81 percent between 2008 and 2012. The harms measured by the Adverse Outcome Index decreased 14 percent, and a run chart analysis revealed two special causes associated with the interventions. This study demonstrates the ability of hospital perinatal staff to implement efforts to reduce perinatal harm using a quality improvement collaborative. Findings help inform the relationship between the use of standardized care processes, teamwork training, and improved perinatal outcomes, and suggest that a multiplicity of integrated strategies, rather than a single intervention, may be essential to achieve high reliability. © Health Research and Educational Trust.

The impact of health information technology adoption by outpatient facilities on pregnancy outcomes.

PubMed

Deily, Mary E; Hu, Tianyan; Terrizzi, Sabrina; Chou, Shin-Yi; Meyerhoefer, Chad D

2013-02-01

Examine whether health information technology (HIT) at nonhospital facilities (NHFs) improves health outcomes and decreases resource use at hospitals within the same heath care network, and whether the impact of HIT varies as providers gain experience using the technologies. Administrative claims data on 491,832 births in Pennsylvania during 1998-2004 from the Pennsylvania Health Care Cost Containment Council and HIT applications data from the Dorenfest Institute. Fixed-effects regression analysis of the impact of HIT at NHFs on adverse birth outcomes and resource use. Greater use of clinical HIT applications by NHFs is associated with reduced incidence of obstetric trauma and preventable complications, as well as longer lengths of stay. In addition, the beneficial effects of HIT increase the longer that technologies have been in use. However, we find no consistent evidence on whether or how nonclinical HIT in NHFs affects either resource use or health outcomes. Clinical HIT applications at NHFs may reduce the likelihood of adverse birth outcomes, particularly after physicians and staff gain experience using the technologies. © Health Research and Educational Trust.

The Impact of Health Information Technology Adoption by Outpatient Facilities on Pregnancy Outcomes

PubMed Central

Deily, Mary E; Hu, Tianyan; Terrizzi, Sabrina; Chou, Shin-Yi; Meyerhoefer, Chad D

2013-01-01

Objective Examine whether health information technology (HIT) at nonhospital facilities (NHFs) improves health outcomes and decreases resource use at hospitals within the same heath care network, and whether the impact of HIT varies as providers gain experience using the technologies. Data Sources Administrative claims data on 491,832 births in Pennsylvania during 1998–2004 from the Pennsylvania Health Care Cost Containment Council and HIT applications data from the Dorenfest Institute. Study Design Fixed-effects regression analysis of the impact of HIT at NHFs on adverse birth outcomes and resource use. Principal Findings Greater use of clinical HIT applications by NHFs is associated with reduced incidence of obstetric trauma and preventable complications, as well as longer lengths of stay. In addition, the beneficial effects of HIT increase the longer that technologies have been in use. However, we find no consistent evidence on whether or how nonclinical HIT in NHFs affects either resource use or health outcomes. Conclusions Clinical HIT applications at NHFs may reduce the likelihood of adverse birth outcomes, particularly after physicians and staff gain experience using the technologies. PMID:22742682

A Quantative Adverse Outcome Pathway Linking Aromatase Inhibition in Fathead Minnows with Population Dynamics

EPA Science Inventory

A Quantitative Adverse Outcome Pathway Linking Aromatase Inhibition in Fathead Minnows with Population DynamicsAn adverse outcome pathway (AOP) is a qualitative description linking a molecular initiating event (MIE) with measureable key events leading to an adverse outcome (AO). ...

Constructing, Quantifying, and Validating an Adverse Outcome Pathway for Vascular Developmental Toxicity

EPA Science Inventory

Constructing, Quantifying, and Validating an Adverse Outcome Pathway for Vascular Developmental Toxicity The adverse outcome pathway (AOP) for embryonic vascular disruption1 leading to a range of adverse prenatal outcomes was recently entered into the AOP wiki and accepted as par...

Relevance of pharmacogenetic aspects of mercaptopurine metabolism in the treatment of interstitial lung disease.

PubMed

Bakker, Jaap A; Drent, Marjolein; Bierau, Jörgen

2007-09-01

Mercaptopurine therapy is increasingly important as immunosuppressive therapy in interstitial lung disease. We focus on human mercaptopurine metabolism and the defects in this metabolism causing adverse drug reactions. Defects in mercaptopurine metabolizing enzymes like thiopurine methyltransferase and inosine triphosphate pyrophosphohydrolase lead to severe adverse drug reactions, sometimes with fatal outcome. Other enzymes, still not thoroughly investigated, can give rise to toxic effects or decreased efficacy in mercaptopurine therapy when the activity of these enzymes is altered. Pharmacogenetic screening of potential patients for mercaptopurine therapy is important to avoid adverse drug reactions caused by inherited enzyme deficiencies in these metabolic pathways. Pretreatment screening for deficiencies of mercaptopurine metabolizing enzymes will significantly reduce the number of patients with an adverse drug reaction and concomitantly associated healthcare costs.

Glucose alert system improves health professional responses to adverse glycaemia and reduces the number of hyperglycaemic episodes in non-critical care inpatients.

PubMed

Kyi, M; Wraight, P R; Rowan, L M; Marley, K A; Colman, P G; Fourlanos, S

2018-06-01

To investigate the effect of a novel glucose alert system, comprising the Melbourne Glucose Alert Pathway and glucose-alert-capable networked blood glucose meters, on nursing and hospital medical officer responses to adverse glycaemia. A prospective, pre- and post-observational study was undertaken in non-critical care wards of a tertiary hospital over 4 months (n=148 or 660 patient-days). The intervention consisted of two components designed to promote a consistent staff response to blood glucose measurements: (1) a clinical escalation pathway, the Melbourne Glucose Alert Pathway, and (2) networked blood glucose meters, which provide a visual alert for out-of-range blood glucose measurement. All consecutive inpatients with diabetes were assessed for diabetes management and capillary blood glucose. The primary outcome was documented nursing and medical staff action in response to episodes of adverse glycaemia (blood glucose >15 mmol/l or <4 mmol/l). Secondary outcomes consisted of glycaemic measures. In response to episodes of adverse glycaemia, nursing action increased (proportion with nursing action: 45% to 73%; P<0.001), and medical action increased (proportion with medical action: 49% to 67%; P=0.011) with the glucose alert system in place. Patient-days with hyperglycaemia (any blood glucose value >15 mmol/l: 24% vs 16%; P=0.012) and patient-days with mean blood glucose >15 mmol/l (7.4% vs 2.6%; P=0.005) decreased. There was no difference in hypoglycaemia incidence. Use of a novel glucose alert system improved health professional responses to adverse glycaemia and decreased hyperglycaemia in the hospital setting. © 2018 Diabetes UK.

A Qualitative Study on the Interconnected Nature of HIV, Water, and Family.

PubMed

Ramirez-Ortiz, Daisy; Zolnikov, Tara Rava

2017-03-01

Human immunodeficiency virus infection/acquired immunodeficiency syndrome (HIV/AIDS) and poor access to water are two primary global health issues. Poor access to water may significantly affect families infected with HIV and result in adverse social and health consequences. A qualitative study used semi-structured interviews to understand health and social outcomes of families after the implementation of water interventions in rural Kenya. One major sub-theme emerged during this research, which included the effects of water on an HIV-affected family. Prior to the water interventions, common adverse health effects from lack of nutrition, water, and poor hygiene were experienced. After receiving access to water, nutrition and hygiene were improved and additional time was gained and used to reinforce relationships and spread awareness about HIV/AIDS. This study provides need-based evidence for access to safe drinking water in order to decrease adverse health outcomes and improve the quality of life for HIV-affected individuals.

Multidisciplinary in-hospital teams improve patient outcomes: A review.

PubMed

Epstein, Nancy E

2014-01-01

The use of multidisciplinary in-hospital teams limits adverse events (AE), improves outcomes, and adds to patient and employee satisfaction. Acting like "well-oiled machines," multidisciplinary in-hospital teams include "staff" from different levels of the treatment pyramid (e.g. staff including nurses' aids, surgical technicians, nurses, anesthesiologists, attending physicians, and others). Their enhanced teamwork counters the "silo effect" by enhancing communication between the different levels of healthcare workers and thus reduces AE (e.g. morbidity/mortality) while improving patient and healthcare worker satisfaction. Multiple articles across diverse disciplines incorporate a variety of concepts of "teamwork" for staff covering emergency rooms (ERs), hospital wards, intensive care units (ICUs), and most critically, operating rooms (ORs). Cohesive teamwork improved communication between different levels of healthcare workers, and limited adverse events, improved outcomes, decreased the length of stay (LOS), and yielded greater patient "staff" satisfaction. Within hospitals, delivering the best medical/surgical care is a "team sport." The goals include: Maximizing patient safety (e.g. limiting AE) and satisfaction, decreasing the LOS, and increasing the quality of outcomes. Added benefits include optimizing healthcare workers' performance, reducing hospital costs/complications, and increasing job satisfaction. This review should remind hospital administrators of the critical need to keep multidisciplinary teams together, so that they can continue to operate their "well-oiled machines" enhancing the quality/safety of patient care, while enabling "staff" to optimize their performance and enhance their job satisfaction.

Predictors for pregnancy outcomes in Romanian women with Type 1 Diabetes Mellitus: a prospective study.

PubMed

Timar, Bogdan; Timar, Romulus; Albai, Alin; Stoian, Dana; Nitu, Razvan; Craina, Marius

2014-01-01

Type 1 diabetes mellitus in pregnant women is associated with an increased risk of congenital malformations, obstetric complications, neonatal morbidity, and mortality. Our aim was to evaluate which factors from the first trimester of pregnancy have a significant impact on the pregnancy outcomes of women with type 1 diabetes. We included 94 pregnant women with type 1 diabetes in this study. In these patients, we analyzed the influence of several diabetes-related parameters on the pregnancy outcome. We compared the parameters between two cohorts: those with successful pregnancies and those with adverse pregnancy outcomes, defined as spontaneous abortion or congenital malformations. The influence of several factors on the pregnancy outcome was assessed using multivariate and univariate logistic regressions. The prevalence of adverse pregnancy outcomes was 28.7%, and was associated with poorer glycemic control (p <0.001), lower frequency of daily self-monitoring tests (p <0.001), smoking status (p <0.001), alcohol consumption (p <0.001), increased prevalence of chronic complications of diabetes, and the presence of ketosis. However, the adverse outcomes were not significantly associated with age, duration of diabetes, presence of thyroid disease, or body mass index. Furthermore, planned pregnancy was found to be a significant protective factor (odds ratio, 0.15; p <0.001). These results indicate that by carefully planning the pregnancy, ensuring optimal glycemic control, and eliminating habitual risk factors, the fetal risk in pregnancies among women with type 1 diabetes may decrease to a value similar to that noted in women without diabetes.

Adverse Outcomes After Hospitalization and Delirium in Persons With Alzheimer Disease

PubMed Central

Fong, Tamara G.; Jones, Richard N.; Marcantonio, Edward R.; Tommet, Douglas; Gross, Alden L.; Habtemariam, Daniel; Schmitt, Eva; Yap, Liang; Inouye, Sharon K.

2012-01-01

Background Hospitalization, frequently complicated by delirium, can be a life-changing event for patients with Alzheimer disease (AD). Objective To determine risks for institutionalization, cognitive decline, or death associated with hospitalization and delirium in patients with AD. Design Prospective cohort enrolled between 1991 and 2006 into the Massachusetts Alzheimer’s Disease Research Center (MADRC) patient registry. Setting Community-based. Participants 771 persons aged 65 years or older with a clinical diagnosis of AD. Measurements Hospitalization, delirium, death, and institutionalization were identified through administrative databases. Cognitive decline was defined as a decrease of 4 or more points on the Blessed Information-Memory-Concentration test score. Multivariate analysis was used to calculate adjusted relative risks (RRs). Results Of 771 participants with AD, 367 (48%) were hospitalized and 194 (25%) developed delirium. Hospitalized patients who did not have delirium had an increased risk for death (adjusted RR, 4.7 [95% CI, 1.9 to 11.6]) and institutionalization (adjusted RR, 6.9 [CI, 4.0 to 11.7]). With delirium, risk for death (adjusted RR, 5.4 [CI, 2.3 to 12.5]) and institutionalization (adjusted RR, 9.3 [CI, 5.5 to 15.7]) increased further. With hospitalization and delirium, the adjusted RR for cognitive decline for patients with AD was 1.6 (CI, 1.2 to 2.3). Among hospitalized patients with AD, 21% of the incidences of cognitive decline, 15% of institutionalization, and 6% of deaths were associated with delirium. Limitations Cognitive outcome was missing in 291 patients. Sensitivity analysis was performed to test the effect of missing data, and a composite outcome was used to decrease the effect of missing data. Conclusion Approximately 1 in 8 hospitalized patients with AD who develop delirium will have at least 1 adverse outcome, including death, institutionalization, or cognitive decline, associated with delirium. Delirium prevention may represent an important strategy for reducing adverse outcomes in this population. Primary Funding Source National Institute on Aging and the MADRC. PMID:22711077

Motor outcome and electrode location in deep brain stimulation in Parkinson's disease.

PubMed

Koivu, Maija; Huotarinen, Antti; Scheperjans, Filip; Laakso, Aki; Kivisaari, Riku; Pekkonen, Eero

2018-05-30

To evaluate the efficacy and adverse effects of subthalamic deep brain stimulation (STN-DBS) in patients with advanced Parkinson's disease (PD) and the possible correlation between electrode location and clinical outcome. We retrospectively reviewed 87 PD-related STN-DBS operations at Helsinki University Hospital (HUH) from 2007 to 2014. The changes of Unified Parkinson's Disease Rating Scale (UPDRS) part III score, Hoehn & Yahr stage, antiparkinson medication, and adverse effects were studied. We estimated the active electrode location in three different coordinate systems: direct visual analysis of MRI correlated to brain atlas, location in relation to the nucleus borders and location in relation to the midcommisural point. At 6 months after operation, both levodopa equivalent doses (LEDs; 35%, Wilcoxon signed-rank test = 0.000) and UPDRS part III scores significantly decreased (38%, Wilcoxon signed-rank test = 0.000). Four patients (5%) suffered from moderate DBS-related dysarthria. The generator and electrodes had to be removed in one patient due to infection (1%). Electrode coordinates in the three coordinate systems correlated well with each other. On the left side, more ventral location of the active contact was associated with greater LED decrease. STN-DBS improves motor function and enables the reduction in antiparkinson medication with an acceptable adverse effect profile. More ventral location of the active contact may allow stronger LED reduction. Further research on the correlation between contact location, clinical outcome, and LED reduction is warranted. © 2018 The Authors. Brain and Behavior published by Wiley Periodicals, Inc.

Peat Biomass Smoke Particle Exposure in Rats Decreases Expiratory Time and Increases Left Heart End Diastolic Volume

EPA Science Inventory

Wildland fires, favored by prolonged drought and rising temperatures, generate significant amounts of ambient particulate matter (PM), which has been linked to adverse health outcomes. The eastern North Carolina peat fires of Pocosin Lake in 2008 and Pains Bay in 2011 were some o...

Cortisol inhibits CSF2 and CSF3 via DNA methylation and inhibits invasion in first-trimester trophoblast cells

PubMed Central

Smith, Arianna; Witte, Elizabeth; McGee, Devin; Knott, Jason; Narang, Kavita; Racicot, Karen

2018-01-01

Problem Heightened maternal stress affects trophoblast function and increases risk for adverse pregnancy outcomes. Methods of Study Studies were performed using the first-trimester trophoblast cell line, Sw.71. Cytokines were quantified using qPCR and ELISA. Epigenetic regulation of cytokines was characterized by inhibiting histone deacetylation (1 μmol/L suberoylanilide hydroxamic acid [SAHA]) or methylation (5 μmol/L 5-azacytidine), or with chromatin immunoprecipitation (ChIP) with a pan-acetyl histone-3 antibody. Invasion assays used Matrigel chambers. Results Cortisol inhibited expression of CSF2 (GM-CSF) and CSF3 (G-CSF) in trophoblast cells. Cortisol-associated inhibition was dependent on DNA methylation and was not affected by acetylation. There was also a modest decrease in trophoblast invasion, not dependent on loss of CSFs. Conclusion In first-trimester trophoblast cells, the physiological glucocorticoid, cortisol, inhibited two cytokines with roles in placental development and decreased trophoblast invasion. Cortisol-associated changes in trophoblast function could increase the risk for immune-mediated abortion or other adverse pregnancy outcomes. PMID:28846166

The predictive effect of insight on adverse clinical outcomes in bipolar I disorder: a two-year prospective study.

PubMed

Yen, Cheng-Fang; Chen, Cheng-Sheng; Yen, Ju-Yu; Ko, Chih-Hung

2008-05-01

Research has revealed that a lack of insight is associated with poorer clinical outcomes in schizophrenia; however, the predictive value of insight on adverse clinical outcomes among bipolar patients is quite understudied. The aim of this prospective study was to examine the impact of insight on adverse clinical outcomes among the patients with bipolar I disorder over a 2-year period. Sixty-five remitted bipolar I disorder patients received follow-up assessments at 3, 6, 9, 12, 18, and 24 months to detect the adverse clinical outcomes defined by the incidence of bipolar-related psychiatric hospitalization, emergency room visits, violent or suicidal behavior. The Schedule of Assessment of Insight was used to provide a baseline insight score. Cox regression analysis was used to examine the predictive value of insight on the adverse clinical outcomes. Impaired insight into treatment and a greater number of previous hospitalizations significantly increased the risk of adverse clinical outcomes with bipolar disorder in the 2-year period. However, insight into recognition of the illness and re-labeling of psychotic phenomena did not have any significant effect on adverse clinical outcomes. Bipolar patients' insight into treatment is an independent predictor of adverse clinical outcomes. Improving insight into treatment might be a promising target for a better outcome.

Postnatal Cardiovascular Consequences in the Offspring of Pregnant Rats Exposed to Smoking and Smoking Cessation Pharmacotherapies.

PubMed

Gopalakrishnan, Kathirvel; More, Amar S; Hankins, Gary D; Nanovskaya, Tatiana N; Kumar, Sathish

2017-06-01

Approximately 20% of pregnant women smoke despite intentions to quit. Smoking cessation drugs, such as nicotine replacement therapy (NRT) and bupropion, are recommended treatments. Adverse cardiovascular outcomes in offspring have raised concerns about NRT's safety during pregnancy. However, the effect of bupropion is unknown. Using a rat model, we determined whether NRT and bupropion interventions during pregnancy are safer than continued smoking on offspring's cardiovascular function. Male offspring of controls and dams exposed to cigarette smoke (1.6 packs/day, inhalation), nicotine (2 mg/kg/d subcutaneously), and bupropion (13 mg/kg twice daily orally) were assessed for fetoplacental weight, cardiac function, blood pressure, and vascular reactivity. Fetoplacental weights were decreased and spontaneous beating and intracellular calcium in neonatal cardiomyocytes were increased in smoking, nicotine, and bupropion offspring; however, these effects were more accentuated in smoking followed by nicotine and bupropion offspring. Increased heart rate and decreased cardiac output, stroke volume, and left ventricular percent posterior wall thickening were observed in smoking, nicotine, and bupropion offspring. The left ventricular mass was reduced in smoking and nicotine but not in bupropion offspring. Blood pressure was higher with decreased endothelium-dependent relaxation and exaggerated vascular contraction to angiotensin II in smoking and nicotine offspring, with more pronounced dysfunctions in smoking than nicotine offspring. Maternal bupropion did not impact offspring's blood pressure, endothelium-dependent relaxation, and vascular contraction. In conclusion, maternal nicotine intervention adversely affects offspring's cardiovascular outcomes, albeit less severely than continued smoking. However, bupropion causes cardiac derangement in offspring but does not adversely affect blood pressure and vascular function.

VA Health Care: Actions Needed to Assess Decrease in Root Cause Analyses of Adverse Events

DTIC Science & Technology

2015-07-01

has been taken to address the root cause. For example, in the case of an overdose of an anesthesia medication from a pump that held an unsafe amount...of medication, the action might be to use a different type of pump that holds less medication and prevents an accidental overdose ; an outcome...measure might be to measure patient outcomes 1 year later to ensure that no such overdoses occurred. VHA policy states that those staff directly involved

A critical pathway for patients with acute chest pain and low risk for short-term adverse cardiac events: role of outpatient stress testing.

PubMed

Meyer, Mary C; Mooney, Robert P; Sekera, Anna K

2006-05-01

We evaluate the safety and feasibility of a critical care pathway protocol in which patients with acute chest pain who are low risk for coronary artery disease and short-term adverse cardiac outcomes receive outpatient stress testing within 72 hours of an emergency department (ED) visit. We performed an observational study of an ED-based chest pain critical pathway in an urban, community hospital in 979 consecutive patients. Patients enrolled in the protocol were observed in the ED before receiving 72-hour outpatient stress testing. The pathway was primarily analyzed for rates of death or myocardial infarction in the 6 months after ED discharge and outpatient stress testing. Secondary outcome measures included need for coronary intervention at initial stress testing and within 6 months after discharge, subsequent ED visits for chest pain, and subsequent hospitalization. Of 871 stress-tested patients aged 40 years or older, who had low risk for coronary artery disease and short-term adverse cardiac events, and had 6-month follow-up, 18 (2%) required coronary intervention, 1 (0.1%) had a myocardial infarction within 1 month, 2 (0.2%) had a myocardial infarction within 6 months, 6 (0.7%) had normal stress test results after discharge but required cardiac catheterization within 6 months, and 5 (0.6%) returned to the ED within 6 months for ongoing chest pain. Hospital admission rates decreased significantly from 31.2% to 26.1% after initiation of the protocol (P<.001). For patients with chest pain and low risk for short-term cardiac events, outpatient stress testing is feasible, safe, and associated with decreased hospital admission rates. With an evidence-based protocol, physicians efficiently identify patients at low risk for clinically significant coronary artery disease and short-term adverse cardiac outcomes.

Testing an integral conceptual model of frailty.

PubMed

Gobbens, Robbert J; van Assen, Marcel A; Luijkx, Katrien G; Schols, Jos M

2012-09-01

This paper is a report of a study conducted to test three hypotheses derived from an integral conceptual model of frailty.   The integral model of frailty describes the pathway from life-course determinants to frailty to adverse outcomes. The model assumes that life-course determinants and the three domains of frailty (physical, psychological, social) affect adverse outcomes, the effect of disease(s) on adverse outcomes is mediated by frailty, and the effect of frailty on adverse outcomes depends on the life-course determinants. In June 2008 a questionnaire was sent to a sample of community-dwelling people, aged 75 years and older (n = 213). Life-course determinants and frailty were assessed using the Tilburg frailty indicator. Adverse outcomes were measured using the Groningen activity restriction scale, the WHOQOL-BREF and questions regarding healthcare utilization. The effect of seven self-reported chronic diseases was examined. Life-course determinants, chronic disease(s), and frailty together explain a moderate to large part of the variance of the seven continuous adverse outcomes (26-57%). All these predictors together explained a significant part of each of the five dichotomous adverse outcomes. The effect of chronic disease(s) on all 12 adverse outcomes was mediated at least partly by frailty. The effect of frailty domains on adverse outcomes did not depend on life-course determinants. Our finding that the adverse outcomes are differently and uniquely affected by the three domains of frailty (physical, psychological, social), and life-course determinants and disease(s), emphasizes the importance of an integral conceptual model of frailty. © 2011 Blackwell Publishing Ltd.

Psychosocial and biological paternal role in pregnancy outcomes.

PubMed

Kashanian, Maryam; Faghankhani, Masoomeh; Hadizadeh, Hasti; Salehi, MMasoud; YousefzadehRoshan, Masoomeh; EhsaniPour, Mohammad; Sayyah, Ladan; Sheikhansari, Narges

2018-06-10

Pregnancy outcomes are affected by many different factors. One of the influential factors on pregnancy outcomes is the male partner as an important person to mother's wellbeing. The aim of the present study was to investigate the effects of male partner's role including socioeconomic support, emotional support, accompanying pregnant women during prenatal care visits (PNC) and labor, and the level of pregnant women's satisfaction from their partners' support and involvement during pregnancy on pregnancy outcomes. Two hundred first gravid pregnant women with mean age of 23.2 ± 4.3 were studied. Primary outcomes were total maternal and neonatal adverse outcome (TMNAO), total maternal adverse end result (TMAE), and total neonatal adverse outcome (TNAO), regardless of the type of outcomes. Preterm labor and delivery; premature rupture of membrane (PROM) and preterm premature rupture of membrane (PPROM); preeclampsia and eclampsia; placental abruption; chorioamnionitis; stillbirth; meconium passage; maternal death; postpartum hemorrhage; poor progression labor; abnormal vaginal bleeding in third trimester of pregnancy; low birth weight and neonatal need for CPR or intubation, neonatal anomaly, NICU admission, and neonatal mortality were also analyzed as subgroup outcomes. 127 (63.5%) participants showed a kind of total maternal and neonatal adverse outcome (TMNAO), 72 (36%) deliveries resulted in a kind of neonatal adverse outcome (TNAO), and 104 (52%) of participants had a kind of maternal adverse end result (TMAE). Iranian fathers showed a significantly higher rate of TMNAO than Afghan fathers did (82 versus 69%, Odd ratio: 2.9, 95% CI 1.0-7.8, P: 0.01). Mother's nationality showed the same result (82 versus 64%, Odd ratio: 2.6, 95% CI 0.9-6.8, P: 0.03). Iranian fathers showed a significantly higher rate of TMAE than Afghan fathers did (79 versus 58%, Odd ratio: 2.7, 95% CI 1.1-6.3, P: 0.01). Mother's nationality showed the same result (78 versus 60%, Odd ratio: 2.4, 95% CI 1.0-5.6, P: 0.02). Neonates with Iranian fathers showed significantly more TNAO than those with Afghan fathers (50 versus 31%, Odd ratio: 2.21, 95% CI 0.9-5.5, P: 0.04). The same trend was observed among Iranian mothers in comparison to Afghan mothers (50 versus 32%, Odd ratio: 2.11, 95% CI 0.9-4.6, P: 0.06). Of mother's age, mother's BMI, father's age, father's BMI, and mother's nationality, only father's BMI contributed significantly to the binary logistic regression model (n = 116, R 2 : 9%, P: 0.028). It was found that for each decreased unit in BMI, the risk of TNAO was increased by 16% P: 0.03. Moreover, Father's family history of preeclampsia resulted in a higher prevalence of total neonatal adverse outcome (TNAO) in comparison with lack of such family history (87 versus 43%, Odd Ratio: 8.9, 95% CI 1.1-74.5, P: 0.02). Besides, mothers' participation in prenatal care (PNC) visits, assessed by caregivers, was significantly more satisfactory in neonates without any adverse outcome than those with neonatal adverse outcomes (median (IQR) = 2 (1-2) versus 2(2-3), P: 0.04). PROM, pre-eclampsia, NICU admission, neonatal intubation, low Apgar score minute 0, and low Apgar score minute 5 were significantly more prevalent in participants revealing positive father's family history of pre-eclampsia. Regarding psychosocial exposures, placental abruption was more prevalent in mothers with exposure to verbal aggression versus nonexposed ones (9 versus 2%, Odd Ratio: 4.0, 95% CI 0.9-24.6, P: 0.04). Moreover, a weak positive association between neonatal gestational age at birth and quality of mother's participation in PNC visits (r: +0.3, P: 0.01) as well as mother's satisfaction from father's commitment to PNC visits was found (r: +0.1, P: 0.03). Male partners may play a key role in pregnant women and fetus's heath.

Physician-led, hospital-linked, birth care centers can decrease cesarean section rates without increasing rates of adverse events.

PubMed

O'Hara, Margaret H; Frazier, Linda M; Stembridge, Travis W; McKay, Robert S; Mohr, Sandra N; Shalat, Stuart L

2013-09-01

This study compares outcomes at a hospital-linked, physician-led, birthing center to a traditional hospital labor and delivery service. Using de-identified electronic medical records, a retrospective cohort design was employed to evaluate 32,174 singleton births during 1998-2005. Compared with hospital service, birth care center delivery was associated with a lower rate of cesarean sections (adjusted Relative Risk = 0.73, 95% confidence interval 0.59-0.91; p < 0.001) without an increased rate of operative vaginal delivery (adjusted Relative Risk = 1.04, 95% confidence interval 0.97-1.13; p = 0.25) and a higher initiation of breastfeeding (adjusted Relative Risk = 1.28, 95% confidence interval 1.25-1.30; p ≤ 0.001). A maternal length of stay greater than 72 hours occurred less frequently in the birth care center (adjusted Relative Risk = 0.60, 95% confidence interval 0.55-0.66; p < 0.001). Comparing only women without major obstetrical risk factors, the differences in outcomes were reduced but not eliminated. Adverse maternal and infant outcomes were not increased at the birth care center. A hospital-linked, physician-led, birth care center has the potential to lower rates of cesarean sections without increasing rates of operative vaginal delivery or other adverse maternal and infant outcomes. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

Accelerating Adverse Outcome Pathway (AOP) development via computationally predicted AOP networks

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework is increasingly being adopted as a tool for organizing and summarizing the mechanistic information connecting molecular perturbations by environmental stressors with adverse outcomes relevant for ecological and human health outcomes. Ho...

Developing and applying adverse outcome pathways: What you need to know

EPA Science Inventory

Adverse outcome pathways (AOPs) are a conceptual framework for organizing existing information concerning the predictive linkages between the initiation or early progression of a biological perturbation in an organism and the adverse outcome(s) of regulatory relevance (e.g., impa...

Root Cause Analysis: Learning from Adverse Safety Events.

PubMed

Brook, Olga R; Kruskal, Jonathan B; Eisenberg, Ronald L; Larson, David B

2015-10-01

Serious adverse events continue to occur in clinical practice, despite our best preventive efforts. It is essential that radiologists, both as individuals and as a part of organizations, learn from such events and make appropriate changes to decrease the likelihood that such events will recur. Root cause analysis (RCA) is a process to (a) identify factors that underlie variation in performance or that predispose an event toward undesired outcomes and (b) allow for development of effective strategies to decrease the likelihood of similar adverse events occurring in the future. An RCA process should be performed within the environment of a culture of safety, focusing on underlying system contributors and, in a confidential manner, taking into account the emotional effects on the staff involved. The Joint Commission now requires that a credible RCA be performed within 45 days for all sentinel or major adverse events, emphasizing the need for all radiologists to understand the processes with which an effective RCA can be performed. Several RCA-related tools that have been found to be useful in the radiology setting include the "five whys" approach to determine causation; cause-and-effect, or Ishikawa, diagrams; causal tree mapping; affinity diagrams; and Pareto charts. © RSNA, 2015.

Temporal and quantitative associations of electronic fetal heart rate monitoring patterns and neonatal outcomes†.

PubMed

Ogunyemi, Dotun; Jovanovski, Andrew; Friedman, Perry; Sweatman, Brittany; Madan, Ichchha

2018-04-06

The objective of this study is to evaluate the associations of electronic fetal heart rate monitoring (EFM) patterns and adverse neonatal outcomes Study design: From 2013 to 2016; 12,067 term, singleton deliveries in labor ≥2 h with abnormal EFM defined as absent accelerations, variable, late or prolonged decelerations, tachycardia, bradycardia, or minimal variability were analyzed as any documentation during labor, in first hour and last hour of labor. Outcomes were composite neonatal adverse outcomes, neonatal intensive care unit (NICU) admission, neonatal hypoxia, neonatal hypoglycemia, umbilical artery pH, and base excess. Independent associations were ascertained using regression analysis. Significant independent associations occurred between any abnormal EFM during the last hour and five adverse neonatal outcomes; between abnormal EFM at any time and one adverse neonatal outcome while there was none with the first hour of labor. In the last hour, accelerations had significant negative associations with three adverse neonatal outcomes, while prolonged decelerations, late decelerations, tachycardia, and bradycardia had significant positive associations with three adverse neonatal outcomes. Throughout labor, increasing accelerations events were significantly negatively correlated with all adverse neonatal outcomes, while increasing frequency of late, variable, and prolonged decelerations were positively associated with five adverse neonatal outcomes. Hierarchical analysis showed that bradycardia/tachycardia contributed only 0.8%, while all EFM periodic changes contributed 1%; the addition of the frequencies of abnormal EFM events contributed 0.6% to the variance in umbilical artery pH and base excess. Terminal EFM patterns are independently associated with neonatal outcomes. Accelerations are protective of adverse neonatal outcomes. Increasing frequency of EFM patterns overtime contributes to neonatal outcome.

Pulmonary vasodilation in acute and chronic heart failure: empiricism and evidence.

PubMed

Guglin, Maya

2011-09-01

Pulmonary hypertension in heart failure is associated with exercise intolerance and adverse outcomes. With the availability of multiple drugs that cause pulmonary vasodilation and decrease pulmonary arterial pressure, pulmonary hypertension becomes an attractive therapeutic target. Out of several classes of medications, oral phosphodiesterase inhibitors emerge as the most promising in terms of symptomatic improvement, hemodynamic benefits, reverse cardiac remodeling, and functional capacity. Future trials will show whether the use of these drugs translates to decreased morbidity and mortality in heart failure.

Ultrasound predictors of neonatal outcome in intrauterine growth restriction.

PubMed

Craigo, S D; Beach, M L; Harvey-Wilkes, K B; D'Alton, M E

1996-11-01

Our purpose was to assess the value of commonly performed ultrasound parameters in predicting neonatal outcome of fetuses with intrauterine growth restriction (IUGR). One hundred twenty-seven patients were identified on ultrasound examination to have IUGR. Estimated weight percentile, amniotic fluid volume, umbilical artery Doppler velocimetry, and head circumference/abdominal circumference ratio were compared with neonatal outcome. Thirty infants had severely adverse courses. The degree of growth restriction was strongly associated with adverse outcome and neonatal death. Umbilical artery Doppler waveforms with absent or reverse end-diastolic flow were predicted of neonatal death, bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), and adverse outcome in general. Oligohydramnios was predictive of adverse outcome and neonatal death. Logistic regression also showed that absent or reverse end-diastolic flow and oligohydramnios were independent predictors of adverse outcome. Ultrasound findings of low estimated weight percentile, absent or reverse end-diastolic umbilical blood flow, and oligohydramnios are independent predictors of adverse neonatal outcome of growth restricted fetuses.

Androgen deprivation therapy impact on quality of life and cardiovascular health, monitoring therapeutic replacement.

PubMed

Trost, Landon W; Serefoglu, Ege; Gokce, Ahmet; Linder, Brian J; Sartor, Alton O; Hellstrom, Wayne J G

2013-02-01

Androgen deprivation therapy (ADT) is commonly utilized in the management of both localized and advanced adenocarcinoma of the prostate. The use of ADT is associated with several adverse events, physical changes, and development of medical comorbidities/mortality. The current article reviews known adverse events associated with ADT as well as treatment options, where available. Current recommendations and guidelines are cited for ongoing monitoring of patients receiving ADT. A PubMed search of topics relating to ADT and adverse outcomes was performed, with select articles highlighted and reviewed based on level of evidence and overall contribution. Reported outcomes of studies detailing adverse effects of ADT were reviewed and discussed. Where available, randomized trials and meta-analyses were reported. ADT may result in several adverse events including decreased libido, erectile dysfunction, vasomotor symptoms, cognitive, psychological and quality of life impairments, weight gain, sarcopenia, increased adiposity, gynecomastia, reduced penile/testicular size, hair changes, periodontal disease, osteoporosis, increased fracture risk, diabetes and insulin resistance, hyperlipidemia, and anemia. The definitive impact of ADT on lipid profiles, cardiovascular morbidity/mortality, and all-cause mortality is currently unknown with available data. Treatment options to reduce ADT-related adverse events include changing to an intermittent treatment schedule, biophysical therapy, counseling, and pharmacotherapy. Patients treated with ADT are at increased risk of several adverse events and should be routinely monitored for the development of potentially significant morbidity/mortality. Where appropriate, physicians should reduce known risk factors and counsel patients as to known risks and benefits of therapy. © 2013 International Society for Sexual Medicine.

Benchmarking surgical incident reports using a database and a triage system to reduce adverse outcomes.

PubMed

Antonacci, Anthony C; Lam, Steven; Lavarias, Valentina; Homel, Peter; Eavey, Roland D

2008-12-01

To study the profile of incidents affecting quality outcomes after surgery by developing a usable operating room and perioperative clinical incident report database and a functional electronic classification, triage, and reporting system. Previously, incident reports after surgery were handled on an individual, episodic basis, which limited the ability to perceive actuarial patterns and meaningfully improve outcomes. Clinical incident reports were experientially generated in the second largest health care system in New York City. Data were entered into a functional classification system organized into 16 categories, and weekly triage meetings were held to electronically review and report summaries on 40 to 60 incident reports per week. System development and deployment reviewed 1041 reports after 19,693 operative procedures. During the next 4 years, 3819 additional reports were generated from 83,988 operative procedures and were reported electronically to the appropriate departments. Number of incident reports generated annually. A significant decrease in volume-adjusted clinical incident reports occurred (from 53 to 39 reports per 1000 procedures) from 2001 to 2005 (P < .001). Reductions in incident reports were observed for ambulatory conversions (74% reduction), wasted implants (65%), skin breakdown (64%), complications in the operating room (42%), laparoscopic conversions (32%), and cancellations (23%) as a result of data-focused process and clinical interventions. Six of 16 categories of incident reports accounted for more than 88% of all incident reports. These data suggest that effective review, communication, and summary feedback of clinical incident reports can produce a statistically significant decrease in adverse outcomes.

Early Elevations of the Complement Activation Fragment C3a and Adverse Pregnancy Outcomes

PubMed Central

Lynch, Anne M.; Gibbs, Ronald S.; Murphy, James R.; Giclas, Patricia C.; Salmon, Jane E.; Holers, V. Michael

2016-01-01

OBJECTIVE To estimate whether elevations of complement C3a early in pregnancy are predictive of the subsequent development of adverse pregnancy outcomes. METHODS A plasma sample was obtained from each enrolled pregnant woman before 20 weeks of gestation. The cohort (n=1,002) was evaluated for the development of adverse pregnancy outcomes defined as hypertensive diseases of pregnancy (gestational hypertension or preeclampsia), preterm birth (before 37 weeks of gestation), premature rupture of the membranes, pregnancy loss (during the embryonic and fetal period), intrauterine growth restriction, and the composite outcome of any adverse outcome. RESULTS One or more adverse pregnancy outcomes occurred in 211 (21%) of the cohort. The mean levels (ng/mL) of C3a in early pregnancy were significantly (P=<.001) higher among women with one or more adverse outcomes (858±435) compared with women with an uncomplicated pregnancy (741±407). Adjusted for parity and prepregnancy body mass index, women with levels of C3a in the upper quartile in early pregnancy were three times more likely to have an adverse outcome later in pregnancy compared with women in the lowest quartile (95% confidence interval, 1.8–4.8; P<.001). The link between early elevated C3a levels and adverse pregnancy outcomes was driven primarily by individual significant (P<.05) associations of C3a with hypertensive diseases of pregnancy, preterm birth, and premature rupture of the membranes. CONCLUSION Elevated C3a as early as the first trimester of pregnancy is an independent predictive factor for adverse pregnancy outcomes, suggesting that complement-related inflammatory events in pregnancy contribute to the subsequent development of poor outcomes at later stages of pregnancy. PMID:21173647

Fluorene-9-bisphenol is anti-oestrogenic and may cause adverse pregnancy outcomes in mice

PubMed Central

Zhang, Zhaobin; Hu, Ying; Guo, Jilong; Yu, Tong; Sun, Libei; Xiao, Xuan; Zhu, Desheng; Nakanishi, Tsuyoshi; Hiromori, Youhei; Li, Junyu; Fan, Xiaolin; Wan, Yi; Cheng, Siyu; Li, Jun; Guo, Xuan; Hu, Jianying

2017-01-01

Bisphenol A (BPA) is used in the production of plastic but has oestrogenic activity. Therefore, BPA substitutes, such as fluorene-9-bisphenol (BHPF), have been introduced for the production of so-called ‘BPA-free' plastics. Here we show that BHPF is released from commercial ‘BPA-free' plastic bottles into drinking water and has anti-oestrogenic effects in mice. We demonstrate that BHPF has anti-oestrogenic activity in vitro and, in an uterotrophic assay in mice, induces low uterine weight, atrophic endometria and causes adverse pregnancy outcomes, even at doses lower than those of BPA for which no observed adverse effect have been reported. Female mice given water containing BHPF released from plastic bottles, have detectable levels of BHPF in serum, low uterine weights and show decreased expressions of oestrogen-responsive genes. We also detect BHPF in the plasma of 7/100 individuals, who regularly drink water from plastic bottles. Our data suggest that BPA substitutes should be tested for anti-oestrogenic activity and call for further study of the toxicological effects of BHPF on human health. PMID:28248286

Do time of birth, unit volume, and staff seniority affect neonatal outcome in deliveries at ≥34+0 weeks of gestation?

PubMed

Reif, P; Pichler, G; Griesbacher, A; Lehner, G; Schöll, W; Lang, U; Hofmann, H; Ulrich, D

2018-06-01

We investigated whether time of birth, unit volume, and staff seniority affect neonatal outcome in neonates born at ≥34 +0 weeks of gestation. Population-based prospective cohort study. Ten public hospitals in the Austrian province of Styria. A total of 87 065 neonates delivered in the period 2004-2015. Based on short-term outcome data, generalised linear mixed models were used to calculate the risk for adverse and severely adverse neonatal outcomes according to time of birth, unit volume, and staff seniority. Neonatal composite adverse and severely adverse outcome measures. The odds ratio for severely adverse events during the night-time (22:01-07:29 hours) compared with the daytime (07:30-15:00 hours) was 1.35 (95% confidence interval, 95% CI 1.13-1.61). There were no significant differences in neonatal outcome comparing weekdays and weekends, and comparing office hours and shifts. Units with 500-1000 deliveries per year had the lowest risk for adverse events. Adverse and severely adverse neonatal outcomes were least common for midwife-guided deliveries, and became more frequent with the level of experience of the doctors attending the delivery. With increasing pregnancy risks, senior staff attending delivery and delivering in a tertiary centre reduce the odds ratio for adverse events. Different times of delivery were associated with increased adverse neonatal outcomes. The management of uncomplicated deliveries by less experienced staff showed no negative impact on perinatal outcome. In contrast, riskier pregnancies delivered by senior staff in a tertiary centre favour a better outcome. Achieving a better balance in the total number of labour ward staff during the day and the night appears to be a greater priority than increasing the continuous presence of senior obstetrical staff on the labour ward during the out-of-hours period. Deliveries during night time lead to a greater number of neonates experiencing severely adverse events. © 2017 Royal College of Obstetricians and Gynaecologists.

Adverse outcome pathways: a concise introduction for toxicologists

PubMed Central

Vergauwen, Lucia; Hengstler, Jan G.; Angrish, Michelle; Whelan, Maurice

2018-01-01

Adverse outcome pathways are designed to provide a clear-cut mechanistic representation of critical toxicological effects that propagate over different layers of biological organization from the initial interaction of a chemical with a molecular target to an adverse outcome at the individual or population level. Adverse outcome pathways are currently gaining momentum, especially in view of their many potential applications as pragmatic tools in the fields of human toxicology, ecotoxicology and risk assessment. A number of guidance documents, issued by the Organization for Economic Cooperation and Development, as well as landmark papers, outlining best practices to develop, assess and use adverse outcome pathways, have been published in the last few years. The present paper provides a synopsis of the main principles related to the adverse outcome pathway framework for the toxicologist less familiar with this area, followed by two case studies relevant for human toxicology and ecotoxicology. PMID:28660287

Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection.

PubMed

Colvin, Richard A; Tanwandee, Tawesak; Piratvisuth, Teerha; Thongsawat, Satawat; Hui, Aric Josun; Zhang, Hongfei; Ren, Hong; Chen, Pei-Jer; Chuang, Wan-Long; Sobhonslidsuk, Abhasnee; Li, Ruobing; Qi, Yin; Praestgaard, Jens; Han, Yi; Xu, Junfang; Stein, Daniel S

2015-01-01

Albinterferon is a fusion of albumin and interferon-α2b developed to improve the pharmacokinetics, convenience, and potential efficacy of interferon-α for the treatment of chronic hepatitis infections. This open-label, randomized, active-controlled, multicenter study investigated the safety and efficacy of albinterferon in patients with chronic hepatitis B virus (HBV) infection who were e-antigen (HBeAg) positive. One hundred and forty-one patients received one of four albinterferon doses/regimens or pegylated-interferon-α2a. Primary efficacy outcomes were changes in serum HBeAg and antibody, HBV-DNA, and alanine aminotransferase. Principal safety outcomes were changes in laboratory values, pulmonary function, and adverse events. The study was prematurely terminated as phase III trials in hepatitis C infection indicated noninferior efficacy but inferior safety compared with pegylated-interferon-α2a. Here, all treatment groups had a significant reduction in HBV-DNA from baseline. Reductions in HBV-DNA were not significantly different, except the 1200 μg every 4 weeks albinterferon dose which was inferior compared with pegylated-interferon-α2a. The serum alanine aminotransferase levels decreased in all arms. The per-patient incidence of adverse events was not significantly different for albinterferon (96.4-100%) and pegylated-interferon-α2a (93.1%). Total adverse events, however, were higher for albinterferon and correlated to dose. Decreased lung function was found in all arms (∼93% of patients), and was more common in some albinterferon groups. Albinterferon doses with similar anti-HBV efficacy to pegylated-interferon-α2a had higher rates of certain adverse events, particularly changes in lung diffusion capacity (http://www.clinicaltrials.gov number NCT00964665). © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

Adverse Outcome Pathways – Tailoring Development to Support Use

EPA Science Inventory

Adverse Outcome Pathways (AOPs) represent an ideal framework for connecting high-throughput screening (HTS) data and other toxicity testing results to adverse outcomes of regulatory importance. The AOP Knowledgebase (AOP-KB) captures AOP information to facilitate the development,...

Adverse outcome pathway (AOP) development I: Strategies and principles

EPA Science Inventory

An adverse outcome pathway (AOP) is a conceptual framework that organizes existing knowledge concerning biologically plausible, and empirically-supported, links between molecular-level perturbation of a biological system and an adverse outcome at a level of biological organizatio...

Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial.

PubMed

da Silva, José Roberto; Borges, Paulo Sérgio; Agra, Karine F; Pontes, Isabelle Albuquerque; Alves, João Guilherme Bezerra

2013-11-19

Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child. Physical exercise is feasible for diabetic pregnant women and contributes to better glycemic control and to a decrease in adverse perinatal outcomes. However, there are no randomized controlled trials (RCT) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes. An RCT will be conducted at Instituto de Medicina Integral Prof Fernando Figueira (IMIP), Brazil. A total of 72 pregnant women will be studied; 36 gestational diabetics will undergo an aquatic physical exercise program in a thermal pool, 3 times per week over 2 months. The primary endpoint will be glucose level control and use of insulin; secondary endpoints will be the following maternal and fetal outcomes: weight gain during pregnancy, blood pressure, pre-eclampsia diagnosis, intrauterus growth restriction, preterm birth, Cesarean section, macrosomia and maternal or neonatal intensive care admission. Endpoints between intervention and control group will analyzed by t test for unpaired data and χ² test, and the level of significance will set at <0.05. The physical proprieties of water make aquatic exercises ideal for pregnant women. An aquatic physical exercise program developed for GDM women will be trialed in a thermal pool and under the supervision of physiotherapist to ensure compliance. It is expected that this study will provide evidence as to the effect of aquatic physical exercise on GDM control. ClinicalTrial.gov, NCT01940003.

Development of computationally predicted Adverse Outcome Pathway (AOP) networks through data mining and integration of publicly available in vivo, in vitro, phenotype, and biological pathway data

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework is increasingly being adopted as a tool for organizing and summarizing the mechanistic information connecting molecular perturbations by environmental stressors with adverse outcomes relevant for ecological and human health outcomes. Ho...

Pregnancy outcomes in women with inflammatory bowel disease following exposure to thiopurines and antitumor necrosis factor drugs: a systematic review with meta-analysis.

PubMed

Mozaffari, S; Abdolghaffari, A H; Nikfar, S; Abdollahi, M

2015-05-01

Several studies have indicated the harmful effect of flare-up periods in pregnant women with inflammatory bowel disease (IBD) on their newborns. Therefore, an effective and safe medical treatment during pregnancy is of great concern in IBD patients. The aim of this study was to perform a meta-analysis on the outcomes of thiopurines use and a systematic review of antitumor necrosis factor (anti-TNF) drugs used during pregnancy in women with IBD. The results of cohorts evaluating the safety of anti-TNF drugs during pregnancy up to July 2013 were collected and analyzed. In the meta-analysis, a total of 312 pregnant women with IBD who used thiopurines were compared with 1149 controls (women with IBD who were not treated with any medication and women who were exposed to drugs other than thiopurines) to evaluate the drug effect on different pregnancy outcomes, including prematurity, low birth weight, congenital abnormalities, spontaneous abortion, and neonatal adverse outcomes. Results of statistical analysis demonstrated that congenital abnormalities were increased significantly in thiopurine-exposed group in comparison with control group who did not receive any medicine for IBD treatment. The summary odds ratio was 2.95 with 95% confidence interval = 1.03-8.43 (p = 0.04). We observed no significant differences in occurrence of other adverse pregnancy outcomes between compared groups. The results of cohorts evaluated the safety of anti-TNF drugs during pregnancy demonstrated no increase in occurrence of adverse pregnancy outcomes in comparison with controls except for the significant decrease in gestational age of newborns of drug-exposed mothers in one trial. In conclusion, a benefit-risk ratio should be considered in prescribing or continuing medicinal therapy during pregnancy of IBD patients. © The Author(s) 2014.

Circulating Angiogenic Factors and the Risk of Adverse Outcomes among Haitian Women with Preeclampsia.

PubMed

March, Melissa I; Geahchan, Carl; Wenger, Julia; Raghuraman, Nandini; Berg, Anders; Haddow, Hamish; Mckeon, Bri Ann; Narcisse, Rulx; David, Jean Louis; Scott, Jennifer; Thadhani, Ravi; Karumanchi, S Ananth; Rana, Sarosh

2015-01-01

Angiogenic factors are strongly associated with adverse maternal and fetal outcomes among women with preterm preeclampsia (PE) in developed countries. We evaluated the role of angiogenic factors and their relationship to adverse outcomes among Haitian women with PE. We measured plasma antiangiogenic soluble fms-like tyrosine kinase 1 (sFlt1) and proangiogenic placental growth factor (PlGF) levels in women with PE (n=35) compared to controls with no hypertensive disorders (NHD) (n=43) among subjects with singleton pregnancies that delivered at Hospital Albert Schweitzer (HAS) in Haiti. We divided the preeclamptic women into two groups, early onset (≤ 34 weeks) and late onset (>34 weeks) and examined relationships between sFlt1/PlGF ratios on admission and adverse outcomes (abruption, respiratory complications, stroke, renal insufficiency, eclampsia, maternal death, birth weight <2500 grams, or fetal/neonatal death) in women with PE subgroups as compared to NHD groups separated by week of admission. Data are presented as median (25th-75th centile), n (%), and proportions. Among patients with PE, most (24/35) were admitted at term. Adverse outcome rates in PE were much higher among the early onset group compared to the late onset group (100.0% vs. 54.2%, P=0.007). Plasma angiogenic factors were dramatically altered in both subtypes of PE. Angiogenic factors also correlated with adverse outcomes in both subtypes of PE. The median sFlt1/PlGF ratios for subjects with early onset PE with any adverse outcome vs. NHD <=34 weeks with no adverse outcome were 703.1 (146.6, 1614.9) and 9.6 (3.5, 58.6); P<0.001). Among late onset group the median sFlt1/PlGF ratio for women with any adverse outcome was 130.7 (56.1, 242.6) versus 22.4 (10.2, 58.7; P=0.005) in NHD >34 weeks with no adverse outcome. PE-related adverse outcomes are common in women in Haiti and are associated with profound angiogenic imbalance regardless of gestational age at presentation.

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes.

PubMed

Valgimigli, Marco; Frigoli, Enrico; Leonardi, Sergio; Rothenbühler, Martina; Gagnor, Andrea; Calabrò, Paolo; Garducci, Stefano; Rubartelli, Paolo; Briguori, Carlo; Andò, Giuseppe; Repetto, Alessandra; Limbruno, Ugo; Garbo, Roberto; Sganzerla, Paolo; Russo, Filippo; Lupi, Alessandro; Cortese, Bernardo; Ausiello, Arturo; Ierna, Salvatore; Esposito, Giovanni; Presbitero, Patrizia; Santarelli, Andrea; Sardella, Gennaro; Varbella, Ferdinando; Tresoldi, Simone; de Cesare, Nicoletta; Rigattieri, Stefano; Zingarelli, Antonio; Tosi, Paolo; van 't Hof, Arnoud; Boccuzzi, Giacomo; Omerovic, Elmir; Sabaté, Manel; Heg, Dik; Jüni, Peter; Vranckx, Pascal

2015-09-10

Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).

ADVERSE CHILDHOOD EXPERIENCES AMONG YOUTH AGING OUT OF FOSTER CARE: A LATENT CLASS ANALYSIS

PubMed Central

Rebbe, Rebecca; Nurius, Paula S.; Ahrens, Kym R.; Courtney, Mark E.

2017-01-01

Research has demonstrated that youth who age out, or emancipate, from foster care face deleterious outcomes across a variety of domains in early adulthood. This article builds on this knowledge base by investigating the role of adverse childhood experience accumulation and composition on these outcomes. A latent class analysis was performed to identify three subgroups: Complex Adversity, Environmental Adversity, and Lower Adversity. Differences are found amongst the classes in terms of young adult outcomes in terms of socio-economic outcomes, psychosocial problems, and criminal behaviors. The results indicate that not only does the accumulation of adversity matter, but so does the composition of the adversity. These results have implications for policymakers, the numerous service providers and systems that interact with foster youth, and for future research. PMID:28458409

Assessing antibacterial pharmacoeconomics in the intensive care unit.

PubMed

Birmingham, M C; Hassett, J M; Schentag, J J; Paladino, J A

1997-12-01

Intensive care units (ICUs) represent areas of high use of antibacterials and other pharmacy goods and services. Many institutions view their ICUs as a target for drug-use surveillance and cost-containment programmes. Economic assessment of antibacterial interventions in the ICU should include all direct costs and patient outcomes. Nonetheless, many of these institutions focus their efforts at reducing antibacterial costs without considering the consequences of these actions. It is possible that devoting more resources to antibacterials can have an overall positive economic impact if more appropriate antibacterial use reduces length of stay, decreases bacterial resistance or lowers frequency of adverse complications. Two consequences of antibacterial use which can result in substantial economic burdens to institutions are drug-induced complications (toxicities and adverse events) and the development of antibacterial-resistant organisms. These events are logical targets for performing pharmacoeconomic studies to evaluate appropriate and inappropriate antibacterial use. Either of these problems can increase length of stay, which is the single most important variable influencing the overall cost of patient care. The primary goal of patient care is to hasten patients' clinical improvement. This will result in decreased antibacterial acquisition costs, decreased lengths of ICU and hospital stays, and ultimately decreased consumption of hospital resources. These can be accomplished by using strategies to guide antibacterial use in order to reduce failures, adverse events, toxicity and antimicrobial resistance.

Setting the stage to advance the adverse outcome pathway (AOP) framework through horizon scanning

EPA Science Inventory

Recognizing the international interest surrounding the adverse outcome pathway framework, which captures existing information describing causal linkages between a molecular initiating event through levels of biological organization to an adverse outcome of regulatory significance...

Adverse Outcome Pathway Network Analyses: Techniques and benchmarking the AOPwiki

EPA Science Inventory

Abstract: As the community of toxicological researchers, risk assessors, and risk managers adopt the adverse outcome pathway (AOP) paradigm for organizing toxicological knowledge, the number and diversity of adverse outcome pathways and AOP networks are continuing to grow. This ...

Adverse Outcome Pathway (AOP) Network Development for Fatty Liver

EPA Science Inventory

Adverse outcome pathways (AOPs) are descriptive biological sequences that start from a molecular initiating event (MIE) and end with an adverse health outcome. AOPs provide biological context for high throughput chemical testing and further prioritize environmental health risk re...

Strategic approaches to adverse outcome pathway development

EPA Science Inventory

Adverse outcome pathways (AOPs) are conceptual frameworks for organizing biological and toxicological knowledge in a manner that supports extrapolation of data pertaining to the initiation or early progression of toxicity to an apical adverse outcome that occurs at a level of org...

Effect of a package of health and nutrition services on sustained recovery in children after moderate acute malnutrition and factors related to sustaining recovery: A cluster-randomized trial

USDA-ARS?s Scientific Manuscript database

Children who recover from moderate acute malnutrition (MAM) have high rates of relapse in the year after nutritional recovery. Interventions to decrease these adverse outcomes are needed to maximize the overall effectiveness of supplemental feeding programs (SFPs). We evaluated the effectiveness of...

Subclinical Hypothyroidism in Pregnancy: A Systematic Review and Meta-Analysis.

PubMed

Maraka, Spyridoula; Ospina, Naykky M Singh; O'Keeffe, Derek T; Espinosa De Ycaza, Ana E; Gionfriddo, Michael R; Erwin, Patricia J; Coddington, Charles C; Stan, Marius N; Murad, M Hassan; Montori, Victor M

2016-04-01

The impact of subclinical hypothyroidism (SCH) and of levothyroxine replacement in pregnant women with SCH is unclear. The aims of this study were to assess (i) the impact of SCH during pregnancy on maternal and neonatal outcomes, and (ii) the effect of levothyroxine replacement therapy in these patients. Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE, the Cochrane Controlled Trials Register, Ovid EMBASE, Web of Science, and Scopus were searched from inception to January 2015. Randomized trials and cohort studies of pregnant women with SCH that examined adverse pregnancy and neonatal outcomes were included. Reviewers extracted data and assessed methodological quality in duplicate. Eighteen cohort studies at low-to-moderate risk of bias were included. Compared with euthyroid pregnant women, pregnant women with SCH were at higher risk for pregnancy loss (relative risk [RR] 2.01 [confidence interval (CI) 1.66-2.44]), placental abruption (RR 2.14 [CI 1.23-3.70]), premature rupture of membranes (RR 1.43 [CI 1.04-1.95]), and neonatal death (RR 2.58 [CI 1.41-4.73]). One study at high risk of bias compared pregnant women with SCH who received levothyroxine to those who did not and found no significant decrease in the rate of pregnancy loss, preterm delivery, gestational hypertension, low birth weight, or low Apgar score. SCH during pregnancy is associated with multiple adverse maternal and neonatal outcomes. The value of levothyroxine therapy in preventing these adverse outcomes remains uncertain.

HIV Protease Inhibitor Use During Pregnancy Is Associated With Decreased Progesterone Levels, Suggesting a Potential Mechanism Contributing to Fetal Growth Restriction

PubMed Central

Papp, Eszter; Mohammadi, Hakimeh; Loutfy, Mona R.; Yudin, Mark H.; Murphy, Kellie E.; Walmsley, Sharon L.; Shah, Rajiv; MacGillivray, Jay; Silverman, Michael; Serghides, Lena

2015-01-01

Background. Protease inhibitor (PI)–based combination antiretroviral therapy (cART) is administered during pregnancy to prevent perinatal human immunodeficiency virus (HIV) transmission. However, PI use has been associated with adverse birth outcomes, including preterm delivery and small-for-gestational-age (SGA) births. The mechanisms underlying these outcomes are unknown. We hypothesized that PIs contribute to these adverse events by altering progesterone levels. Methods. PI effects on trophoblast progesterone production were assessed in vitro. A mouse pregnancy model was used to assess the impact of PI-based cART on pregnancy outcomes and progesterone levels in vivo. Progesterone levels were assessed in plasma specimens from 27 HIV-infected and 17 HIV-uninfected pregnant women. Results. PIs (ritonavir, lopinavir, and atazanavir) but not nucleoside reverse transcriptase inhibitors (NRTIs) or nonnucleoside reverse transcriptase inhibitors reduced trophoblast progesterone production in vitro. In pregnant mice, PI-based cART but not dual-NRTI therapy was associated with significantly lower progesterone levels that directly correlated with fetal weight. Progesterone supplementation resulted in a significant improvement in fetal weight. We observed lower progesterone levels and smaller infants in HIV-infected women receiving PI-based cART, compared with the control group. In HIV-infected women, progesterone levels correlated significantly with birth weight percentile. Conclusions. Our data suggest that PI use in pregnancy may lead to lower progesterone levels that could contribute to adverse birth outcomes. PMID:25030058

HIV protease inhibitor use during pregnancy is associated with decreased progesterone levels, suggesting a potential mechanism contributing to fetal growth restriction.

PubMed

Papp, Eszter; Mohammadi, Hakimeh; Loutfy, Mona R; Yudin, Mark H; Murphy, Kellie E; Walmsley, Sharon L; Shah, Rajiv; MacGillivray, Jay; Silverman, Michael; Serghides, Lena

2015-01-01

Protease inhibitor (PI)-based combination antiretroviral therapy (cART) is administered during pregnancy to prevent perinatal human immunodeficiency virus (HIV) transmission. However, PI use has been associated with adverse birth outcomes, including preterm delivery and small-for-gestational-age (SGA) births. The mechanisms underlying these outcomes are unknown. We hypothesized that PIs contribute to these adverse events by altering progesterone levels. PI effects on trophoblast progesterone production were assessed in vitro. A mouse pregnancy model was used to assess the impact of PI-based cART on pregnancy outcomes and progesterone levels in vivo. Progesterone levels were assessed in plasma specimens from 27 HIV-infected and 17 HIV-uninfected pregnant women. PIs (ritonavir, lopinavir, and atazanavir) but not nucleoside reverse transcriptase inhibitors (NRTIs) or nonnucleoside reverse transcriptase inhibitors reduced trophoblast progesterone production in vitro. In pregnant mice, PI-based cART but not dual-NRTI therapy was associated with significantly lower progesterone levels that directly correlated with fetal weight. Progesterone supplementation resulted in a significant improvement in fetal weight. We observed lower progesterone levels and smaller infants in HIV-infected women receiving PI-based cART, compared with the control group. In HIV-infected women, progesterone levels correlated significantly with birth weight percentile. Our data suggest that PI use in pregnancy may lead to lower progesterone levels that could contribute to adverse birth outcomes. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

Are women positive for the One Step but negative for the Two Step screening tests for gestational diabetes at higher risk for adverse outcomes?

PubMed

Caissutti, Claudia; Khalifeh, Adeeb; Saccone, Gabriele; Berghella, Vincenzo

2018-02-01

The aim of this study was to evaluate if women meeting criteria for gestational diabetes mellitus (GDM) by the One Step test as per International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria but not by other less strict criteria have adverse pregnancy outcomes compared with GDM-negative controls. The primary outcome was the incidence of macrosomia, defined as birthweight > 4000 g. Electronic databases were searched from their inception until May 2017. All studies identifying pregnant women negative at the Two Step test, but positive at the One Step test for IADPSG criteria were included. We excluded studies that randomized women to the One Step vs. the Two Step tests; studies that compared different criteria within the same screening method; randomized studies comparing treatments for GDM; and studies comparing incidence of GDM in women doing the One Step test vs. the Two Step test. Eight retrospective cohort studies, including 29 983 women, were included. Five study groups and four control groups were identified. The heterogeneity between the studies was high. Gestational hypertension, preeclampsia and large for gestational age, as well as in some analyses cesarean delivery, macrosomia and preterm birth, were significantly more frequent, and small for gestational age in some analyses significantly less frequent, in women GDM-positive by the One Step, but not the Two Step. Women meeting criteria for GDM by IADPSG criteria but not by other less strict criteria have an increased risk of adverse pregnancy outcomes such as gestational hypertension, preeclampsia and large for gestational age, compared with GDM-negative controls. Based on these findings, and evidence from other studies that treatment decreases these adverse outcomes, we suggest screening for GDM using the One Step IADPSG criteria. © 2017 Nordic Federation of Societies of Obstetrics and Gynecology.

Effect of intra-pregnancy nonsurgical periodontal therapy on inflammatory biomarkers and adverse pregnancy outcomes: a systematic review with meta-analysis.

PubMed

da Silva, Helbert Eustáquio Cardoso; Stefani, Cristine Miron; de Santos Melo, Nilce; de Almeida de Lima, Adriano; Rösing, Cassiano Kuchenbecker; Porporatti, André Luís; Canto, Graziela De Luca

2017-10-10

The aim of this systematic review with meta-analysis was to analyze the effects of intra-pregnancy nonsurgical periodontal therapy on periodontal inflammatory biomarkers and adverse pregnancy outcomes. On June 5, 2017, we searched PubMed, Cochrane, SCOPUS, Web of Science, LILACS, ProQuest, Open Grey, and Google Scholar databases. Randomized clinical trials in which pregnant women with chronic periodontitis underwent nonsurgical periodontal therapy, compared with an untreated group, tested for inflammatory biomarkers, and followed till delivery were included. Primary outcomes were preterm birth, low birth weight, and preeclampsia. Meta-analysis was performed with 5.3.5 version of Review Manager software. We found 565 references in the databases, 326 after duplicates removal, 28 met criteria for full text reading, and 4 met eligibility criteria for quantitative and qualitative synthesis. Intra-pregnancy nonsurgical periodontal therapy improved periodontal clinical parameters (periodontal pocket depth, clinical attachment level, and bleeding on probing) and reduced biomarker level from gingival crevicular fluid (GCF), and some from blood serum; however, it did not influence biomarker level from umbilical cord blood. Meta-analysis showed tendency for reduction of the risk of preterm birth before 37 weeks for treated group (risk ratio (RR) = 0.54, 95% CI 0.38-0.77; p = 0.0007; inconsistency indexes (I2) 32%) but did not show any difference for low birth weight occurrence (RR = 0.78, 95%CI 0.50-1.21; p = 0.27; I2 41%). No included study considered preeclampsia as a gestational outcome. These results demonstrated that the intra-pregnancy nonsurgical periodontal therapy decreased periodontal inflammatory biomarker levels from gingival crevicular fluid and some from serum blood, with no influence on inflammatory biomarker level from cord blood, and it did not consistently reduce adverse gestational adverse outcome occurrence. PROSPERO CRD42015027750.

An Integrative data mining approach to identifying Adverse Outcome Pathway (AOP) Signatures

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework is a tool for making biological connections and summarizing key information across different levels of biological organization to connect biological perturbations at the molecular level to adverse outcomes for an individual or populatio...

An “ADME Module” in the Adverse Outcome Pathway Knowledgebase

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework has generated intense interest for its utility to organize knowledge on the toxicity mechanisms, starting from a molecular initiating event (MIE) to an adverse outcome across various levels of biological organization. While the AOP fra...

Adverse Outcome Pathways: From Research to Regulation - Scientific Workshop Report

EPA Science Inventory

An adverse outcome pathway (AOP) organizes existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify...

Quantitative Adverse Outcome Pathways and Their Application to Predictive Toxicology

EPA Science Inventory

A quantitative adverse outcome pathway (qAOP) consists of one or more biologically based, computational models describing key event relationships linking a molecular initiating event (MIE) to an adverse outcome. A qAOP provides quantitative, dose–response, and time-course p...

The Association Between Learning Climate and Adverse Obstetrical Outcomes in 16 Nontertiary Obstetrics-Gynecology Departments in the Netherlands.

PubMed

Smirnova, Alina; Ravelli, Anita C J; Stalmeijer, Renée E; Arah, Onyebuchi A; Heineman, Maas Jan; van der Vleuten, Cees P M; van der Post, Joris A M; Lombarts, Kiki M J M H

2017-12-01

To investigate the association between learning climate and adverse perinatal and maternal outcomes in obstetrics-gynecology departments. The authors analyzed 23,629 births and 103 learning climate evaluations from 16 nontertiary obstetrics-gynecology departments in the Netherlands in 2013. Multilevel logistic regressions were used to calculate the odds of adverse perinatal and maternal outcomes, by learning climate score tertile, adjusting for maternal and department characteristics. Adverse perinatal outcomes included fetal or early neonatal mortality, five-minute Apgar score < 7, or neonatal intensive care unit admission for ≥ 24 hours. Adverse maternal outcomes included postpartum hemorrhage and/or transfusion, death, uterine rupture, or third- or fourth-degree perineal laceration. Bias analyses were conducted to quantify the sensitivity of the results to uncontrolled confounding and selection bias. Learning climate scores were significantly associated with increased odds of adverse perinatal outcomes (aOR 2.06, 95% CI 1.14-3.72). Compared with the lowest tertile, departments in the middle tertile had 46% greater odds of adverse perinatal outcomes (aOR 1.46, 95% CI 1.09-1.94); departments in the highest tertile had 69% greater odds (aOR 1.69, 95% CI 1.24-2.30). Learning climate was not associated with adverse maternal outcomes (middle vs. lowest tertile: OR 1.04, 95% CI 0.93-1.16; highest vs. lowest tertile: OR 0.98, 95% CI 0.88-1.10). Learning climate was associated with significantly increased odds of adverse perinatal, but not maternal, outcomes. Research in similar clinical contexts is needed to replicate these findings and explore potential mechanisms behind these associations.

Cryotherapy on postoperative rehabilitation of joint arthroplasty.

PubMed

Ni, Sheng-Hui; Jiang, Wen-Tong; Guo, Lei; Jin, Yu-Heng; Jiang, Tian-Long; Zhao, Yuyan; Zhao, Jie

2015-11-01

The effectiveness of cryotherapy on joint arthroplasty recovery remains controversial. This systematic review was conducted to assess the effectiveness of cryotherapy in patients after joint arthroplasty. Comprehensive literature searches of several databases including Cochrane Library (2013), MEDLINE (1950-2013), and Embase (1980-2013) were performed. We sought randomised controlled trials that compared the experimental group received any form of cryotherapy with any control group after joint arthroplasty. The main outcomes were postoperative blood loss, adverse events, and pain. Analyses were performed with Revman 5.0. Results were shown as mean differences (MD) and standard deviations or as risk difference and 95 % confidence intervals (CIs). Ten trials comprised 660 total knee arthroplastys and three trials comprised 122 total hip arthroplastys (THAs) met the inclusion criteria. Blood loss was significantly decreased by cryotherapy (MD = -109.68; 95 % CI -210.92 to -8.44; P = 0.03). Cryotherapy did not increase the risk of adverse effect (n.s.). Cryotherapy decreased pain at the second day of postoperative (MD = -1.32; 95 % CI -2.37 to -0.27; P = 0.0003), but did not decreased pain at the first and third day of postoperative (n.s.). Cryotherapy appears effective in these selected patients after joint arthroplasty. The benefits of cryotherapy on blood loss after joint arthroplasty were obvious. However, the subgroup analysis indicated that cryotherapy did not decreased blood loss after THA. Cryotherapy did not increase the risk of adverse effect. Cryotherapy decreased pain at the second day of postoperative, but did not decreased pain at the first and third day of postoperative. II.

Umbilical cord entanglement's frequency and its impact on the newborn.

PubMed

Walla, Tatjana; Rothschild, Markus A; Schmolling, Jan C; Banaschak, Sibylle

2018-05-01

Neonaticide is a serious allegation that needs a complete chain of criminal investigations. In this context, a nuchal cord is considered to be responsible for an infant's death, but there is a clear lack of evidence. The purpose of our study is to reveal if a nuchal cord can be responsible for stillbirth, poor perinatal outcome, or neonatal death in the forensic aspect. We conducted a prospective study in collaboration with the Augustinian Sisters' Hospital in Cologne, Germany in the period from February 2014 to May 2016. Four-hundred eighty-six children were enrolled. All births were assessed regarding the occurrence of an umbilical cord entanglement, and perinatal outcome was measured by arterial blood gas analysis, Apgar after 1, 5, and 10 min after birth as well as the general vitality. The prevalence of a nuchal cord was 16.87%. Apgar decrease and acidosis were significantly associated with a nuchal cord. No adverse perinatal outcome was recorded in this constellation. There was no child death regarding the first 24 h, and no mother experienced a syncope while giving birth. We can conclude that a nuchal cord is not associated with adverse perinatal outcome.

Irritability Trajectories, Cortical Thickness, and Clinical Outcomes in a Sample Enriched for Preschool Depression.

PubMed

Pagliaccio, David; Pine, Daniel S; Barch, Deanna M; Luby, Joan L; Leibenluft, Ellen

2018-05-01

Cross-sectional, longitudinal, and genetic associations exist between irritability and depression. Prior studies have examined developmental trajectories of irritability, clinical outcomes, and associations with child and familial depression. However, studies have not integrated neurobiological measures. The present study examined developmental trajectories of irritability, clinical outcomes, and cortical structure among preschoolers oversampled for depressive symptoms. Beginning at 3 to 5 years old, a sample of 271 children enriched for early depressive symptoms were assessed longitudinally by clinical interview. Latent class mixture models identified trajectories of irritability severity. Risk factors, clinical outcomes, and cortical thickness were compared across trajectory classes. Cortical thickness measures were extracted from 3 waves of magnetic resonance imaging at 7 to 12 years of age. Three trajectory classes were identified among these youth: 53.50% of children exhibited elevated irritability during preschool that decreased longitudinally, 30.26% exhibited consistently low irritability, and 16.24% exhibited consistently elevated irritability. Compared with other classes, the elevated irritability class exhibited higher rates of maternal depression, early life adversity, later psychiatric diagnoses, and functional impairment. Further, elevated baseline irritability predicted later depression beyond adversity and personal and maternal depression history. The elevated irritability class exhibited a thicker cortex in the left superior frontal and temporal gyri and the right inferior parietal lobule. Irritability manifested with specific developmental trajectories in this sample enriched for early depression. Persistently elevated irritability predicted poor psychiatric outcomes, higher risk for later depression, and decreased overall function later in development. Greater frontal, temporal, and parietal cortical thickness also was found, providing neural correlates of this risk trajectory. Copyright © 2018 American Academy of Child and Adolescent Psychiatry. All rights reserved.

Intravenous maintenance fluid therapy in children.

PubMed

McNab, Sarah

2016-02-01

Intravenous fluids are frequently used in paediatrics but have been associated with significant adverse outcomes. Understanding the composition of fluid prescribed and administering an appropriate rate is essential for safe fluid administration, along with regular monitoring. Recent evidence has shown that using an isotonic fluid with a sodium concentration similar to plasma can decrease the risk of hyponatraemia without an increase in adverse effects. This should lead to a change in guidelines: isotonic fluid should now be used as the primary maintenance intravenous fluid given to the majority of children. © 2016 The Author Journal of Paediatrics and Child Health © 2016 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Development of an adverse outcome pathway for acetylcholinesterase inhibition leading to acute mortality

EPA Science Inventory

Adverse outcome pathways (AOPs) are designed to describe linkages of key events (KEs) within a biological pathway that result in an adverse outcome associated with chemical perturbation of a well-defined molecular initiating event (MIE). Risk assessors have traditionally relied ...

Discriminative ability of commonly used indices to predict adverse outcomes after poster lumbar fusion: a comparison of demographics, ASA, the modified Charlson Comorbidity Index, and the modified Frailty Index.

PubMed

Ondeck, Nathaniel T; Bohl, Daniel D; Bovonratwet, Patawut; McLynn, Ryan P; Cui, Jonathan J; Shultz, Blake N; Lukasiewicz, Adam M; Grauer, Jonathan N

2018-01-01

As research tools, the American Society of Anesthesiologists (ASA) physical status classification system, the modified Charlson Comorbidity Index (mCCI), and the modified Frailty Index (mFI) have been associated with complications following spine procedures. However, with respect to clinical use for various adverse outcomes, no known study has compared the predictive performance of these indices specifically following posterior lumbar fusion (PLF). This study aimed to compare the discriminative ability of ASA, mCCI, and mFI, as well as demographic factors including age, body mass index, and gender for perioperative adverse outcomes following PLF. A retrospective review of prospectively collected data was performed. Patients undergoing elective PLF with or without interbody fusion were extracted from the 2011-2014 American College of Surgeons National Surgical Quality Improvement Program (NSQIP). Perioperative adverse outcome variables assessed included the occurrence of minor adverse events, severe adverse events, infectious adverse events, any adverse event, extended length of hospital stay, and discharge to higher-level care. Patient comorbidity indices and characteristics were delineated and assessed for discriminative ability in predicting perioperative adverse outcomes using an area under the curve analysis from the receiver operating characteristics curves. In total, 16,495 patients were identified who met the inclusion criteria. The most predictive comorbidity index was ASA and demographic factor was age. Of these two factors, age had the larger discriminative ability for three out of the six adverse outcomes and ASA was the most predictive for one out of six adverse outcomes. A combination of the most predictive demographic factor and comorbidity index resulted in improvements in discriminative ability over the individual components for five of the six outcome variables. For PLF, easily obtained patient ASA and age have overall similar or better discriminative abilities for perioperative adverse outcomes than numerically tabulated indices that have multiple inputs and are harder to implement in clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

Risk Factors and Risk Stratification for Adverse Obstetrical Outcomes After Appendectomy or Cholecystectomy During Pregnancy

PubMed Central

Guglielminotti, Jean; Miller, Russell; Landau, Ruth; Smiley, Richard; Li, Guohua

2017-01-01

Importance Identification of risk factors for adverse obstetrical outcomes after appendectomy and cholecystectomy during pregnancy is necessary for evidence-based risk reduction and adequate patient counseling. Objectives To identify risk factors for adverse obstetrical outcomes after appendectomy and cholecystectomy during pregnancy and stratify the risk of such outcomes. Design, Setting, and Participants A cohort study was conducted using the Nationwide Inpatient Sample, a nationally representative sample of patients discharged from community hospitals in the United States, from January 1, 2003, to December 31, 2012. Multivariable analysis of risk factors for adverse obstetric outcomes was performed for 19 926 women undergoing appendectomy or cholecystectomy during pregnancy and a scoring system for such risk factors was developed. Data analysis was conducted from January 1, 2015, to July 31, 2016. Main Outcomes and Measures A composite measure including 7 adverse obstetrical outcomes throughout pregnancy and occurring before hospital discharge. Results Of the 19 926 women (mean [SD] age, 26 [6] years) in the study, 1018 adverse obstetrical events were recorded in 953 pregnant women (4.8%). The 3 most frequent adverse events were preterm delivery (360 [35.4%]), preterm labor without preterm delivery (269 [26.4%]), and miscarriage (262 [25.7%]). The risk factors associated most strongly with an adverse obstetrical outcome included cervical incompetence (adjusted odds ratio, 24.29; 95% CI, 7.48-78.81), preterm labor during current pregnancy (adjusted odds ratio, 18.34; 95% CI, 4.95-67.96), vaginitis or vulvovaginitis (adjusted odds ratio, 5.17; 95% CI, 2.19-12.23), and sepsis (adjusted odds ratio, 3.39; 95% CI, 2.08-5.51). A scoring system based on statistically significant variables classified the study sample into 3 risk groups corresponding to predicted probabilities of adverse obstetrical outcomes of 2.5% (≤4 points), 8.2% (5-8 points), and 21.8% (≥9 points). Conclusions and Relevance Approximately 5% of women experience adverse obstetrical outcomes after appendectomy or cholecystectomy during pregnancy. The major risk factors for such outcomes are cervical incompetence, preterm labor during current pregnancy, vaginitis or vulvovaginitis, and sepsis. PMID:28114513

Adverse pregnancy outcomes following syphilis treatment in pregnancy in the UK.

PubMed

Wallace, Harriet E; Isitt, Catherine E; Broomhall, Harriet M; Perry, Alison E; Wilson, Janet D

2016-10-01

Syphilis infection in pregnancy is known to cause a number of severe adverse pregnancy outcomes, including second-trimester miscarriage, stillbirth, very pre-term delivery and neonatal death, in addition to congenital syphilis. A retrospective review of women with positive syphilis serology and a pregnancy outcome between 2005 and 2012 in Leeds, UK, was performed. In all, 57 cases of positive syphilis serology in pregnancy were identified: 24 with untreated syphilis treated in the current pregnancy (Group 1); seven with reported but unconfirmed prior treatment who were retreated (Group 2); and 26 adequately treated prior to pregnancy (Group 3). The rate of severe adverse pregnancy outcomes in Group 1 at 21% was significantly higher than the 0% outcome of Group 3 (p = 0.02). The severe adverse pregnancy outcomes were two second-trimester miscarriages, two pre-term births at 25 and 28 weeks and one stillbirth at 32 weeks. There were no cases of term congenital syphilis or term neonatal death, but we observed high rates of other adverse pregnancy outcomes despite treatment during pregnancy. Rapid referral for treatment is needed before 18 weeks in order to minimise adverse pregnancy outcomes. © The Author(s) 2016.

Association between Exposure of Young Children to Procedures Requiring General Anesthesia and Learning and Behavioral Outcomes in a Population-based Birth Cohort.

PubMed

Hu, Danqing; Flick, Randall P; Zaccariello, Michael J; Colligan, Robert C; Katusic, Slavica K; Schroeder, Darrell R; Hanson, Andrew C; Buenvenida, Shonie L; Gleich, Stephen J; Wilder, Robert T; Sprung, Juraj; Warner, David O

2017-08-01

Exposure of young animals to general anesthesia causes neurodegeneration and lasting behavioral abnormalities; whether these findings translate to children remains unclear. This study used a population-based birth cohort to test the hypothesis that multiple, but not single, exposures to procedures requiring general anesthesia before age 3 yr are associated with adverse neurodevelopmental outcomes. A retrospective study cohort was assembled from children born in Olmsted County, Minnesota, from 1996 to 2000 (inclusive). Propensity matching selected children exposed and not exposed to general anesthesia before age 3 yr. Outcomes ascertained via medical and school records included learning disabilities, attention-deficit/hyperactivity disorder, and group-administered ability and achievement tests. Analysis methods included proportional hazard regression models and mixed linear models. For the 116 multiply exposed, 457 singly exposed, and 463 unexposed children analyzed, multiple, but not single, exposures were associated with an increased frequency of both learning disabilities and attention-deficit/hyperactivity disorder (hazard ratio for learning disabilities = 2.17 [95% CI, 1.32 to 3.59], unexposed as reference). Multiple exposures were associated with decreases in both cognitive ability and academic achievement. Single exposures were associated with modest decreases in reading and language achievement but not cognitive ability. These findings in children anesthetized with modern techniques largely confirm those found in an older birth cohort and provide additional evidence that children with multiple exposures are more likely to develop adverse outcomes related to learning and attention. Although a robust association was observed, these data do not determine whether anesthesia per se is causal.

Use of oseltamivir after influenza infection is associated with reduced incidence of recurrent adverse cardiovascular outcomes among military health system beneficiaries with prior cardiovascular diseases.

PubMed

Casscells, S Ward; Granger, Elder; Kress, Amii M; Linton, Andrea; Madjid, Mohammad; Cottrell, Linda

2009-03-01

Influenza infection has been associated with increased risk of adverse cardiac and cerebral vascular outcomes. Oseltamivir, a treatment for influenza, has been shown to decrease the severity of an influenza episode, but few data exist regarding its potentially protective effect against recurrent vascular outcomes among influenza patients with a history of vascular disease. Electronic healthcare service and pharmacy records for 37,482 TRICARE beneficiaries, aged 18 and older, with a coded history of cardiovascular (CV) disease and a subsequent diagnosis of influenza from October 1, 2003, through September 30, 2007, were examined. Subjects were grouped according to whether they had filled a prescription for oseltamivir within 2 days of their influenza diagnosis. The incidence of recurrent CV events within 30 days after the influenza diagnosis among oseltavmivir-treated and untreated subjects was 8.5% and 21.2%, respectively (P<0.005). Subject age was a persistent and significant contributor to the likelihood of recurrent CV outcomes. After controlling for the differences in demographics among treated and untreated cohorts using a propensity-scored logistic regression model, a statistically significant protective effect was associated with oseltamivir treatment (odds ratio, 0.417; 95% CI, 0.349 to 0.498). Our findings suggests that oseltamivir treatment for influenza is associated with significant decrease in the risk of recurrent CV events in subjects with a history of CV disease. These findings merit confirmation in further prospective and controlled studies. Meanwhile, in patients with CV disease, strict adherence with current practice guidelines for prevention and treatment of influenza is recommended.

Adverse psychological outcomes following colposcopy and related procedures: a systematic review.

PubMed

O'Connor, M; Gallagher, P; Waller, J; Martin, C M; O'Leary, J J; Sharp, L

2016-01-01

Although colposcopy is the leading follow-up option for women with abnormal cervical cytology, little is known about its psychological consequences. We performed a systematic review to examine: (1) what, if any, are the adverse psychological outcomes following colposcopy and related procedures; (2) what are the predictors of adverse psychological outcomes post-colposcopy; and (3) what happens to these outcomes over time. Five electronic databases (PubMed, PsychINFO, CINAHL, Web of Science, Scopus) were searched for studies published in English between January 1986 and February 2014. Eligible studies assessed psychological wellbeing at one or more time-points post-colposcopy. Two reviewers independently screened titles and abstracts. Full texts of potentially eligible papers were reviewed. Data were abstracted from, and a quality appraisal performed of, eligible papers. Twenty-three papers reporting 16 studies were eligible. Colposcopy and related procedures can lead to adverse psychological outcomes, particularly anxiety. Ten studies investigated predictors of adverse psychological outcomes; management type and treatment had no impact on this. Seven studies investigated temporal trends in psychological outcomes post-colposcopy; findings were mixed, especially in relation to anxiety and distress. Studies were methodologically heterogeneous. Follow-up investigations and procedures for abnormal cervical cytology can cause adverse psychological outcomes among women. However, little is known about the predictors of these outcomes or how long they persist. There is a need for a more standardised approach to the examination of the psychological impact of colposcopy, especially longer-term outcomes. Follow-up investigations for abnormal cervical cytology can cause adverse psychological outcome among women. © 2015 Royal College of Obstetricians and Gynaecologists.

Can Erythrocytes Transmit Oxidative Stress Beyond the Lungs? An Adverse Outcome Pathway for the Cardiovascular Effects of Air Pollution.

EPA Science Inventory

Adverse outcome pathways (AOPs) are systems biology roadmaps with potential utility in xenobiotic exposure risk assessment. AOPs connect molecular initiating events (MIEs) to population-level adverse outcomes (AOs) via cellular, organ, and organism key events (KE) and KE relatio...

Evaluation of hypothesized adverse outcome pathway linking thyroid peroxidase inhibition to fish early life stage toxicity

EPA Science Inventory

There is an interest in developing alternatives to the fish early-life stage (FELS) test (OECD test guideline 210), for predicting adverse outcomes (e.g., impacts on growth and survival) using less resource-intensive methods. Development and characterization of adverse outcome pa...

Generation of computationally predicted Adverse Outcome Pathway networks through integration of publicly available in vivo, in vitro, phenotype, and biological pathway data.

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework is becoming a widely used tool for organizing and summarizing the mechanistic information connecting molecular perturbations by environmental stressors with adverse ecological and human health outcomes. However, the conventional process...

Practical approaches to adverse outcome pathway development and weight‐of‐evidence evaluation as illustrated by ecotoxicological case studies

EPA Science Inventory

Adverse Outcome Pathways (AOPs) describe toxicant effects as a sequential chain of causally linked events beginning with a molecular perturbation and culminating in an adverse outcome at an individual or population level. Strategies for developing AOPs are still evolving and dep...

Frameworks for organizing exposure and toxicity data - the Aggregate Exposure Pathway (AEP) and the Adverse Outcome Pathway (AOP)

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework organizes existing knowledge regarding a series of biological events, starting with a molecular initiating event (MIE) and ending at an adverse outcome. The AOP framework provides a biological context to interpret in vitro toxicity dat...

PUTATIVE ADVERSE OUTCOME PATHWAY FOR INHIBITON OF BRAIN AROMATASE IN FISH LEADING TO REPRODUCTIVE IMPAIRMENT

EPA Science Inventory

The adverse outcome pathway (AOP) provides a framework for organizing knowledge to define links between a molecular initiating event (MIE) and an adverse outcome (AO) occurring at a higher level of biological organization, such as the individual or population. The AOP framework p...

Intimate Partner Violence, PTSD, and Adverse Health Outcomes

ERIC Educational Resources Information Center

Dutton, Mary Ann; Green, Bonnie L.; Kaltman, Stacey I.; Roesch, Darren M.; Zeffiro, Thomas A.; Krause, Elizabeth D.

2006-01-01

The high prevalence of adverse health outcomes related to intimate partner violence (IPV) is well documented. Yet we know little about the pathways that lead to adverse health outcomes. Research concerning the psychological, biological, neurological, behavioral, and physiological alterations following exposure to IPV--many of which are associated…

Determinants of access to antenatal care and birth outcomes in Kumasi, Ghana

PubMed Central

Ntui, Asundep N.; Carson, April; Turpin, Cornelius Archer; Berhanu, Tameru; Agidi, Ada; Zhang, Kui; Jolly, Pauline E.

2013-01-01

This study aimed to investigate factors that influence antenatal care utilization and their association with adverse pregnancy outcomes (defined as low birth weight, stillbirth, preterm delivery or small for gestational age) among pregnant women in Kumasi. A quantitative cross-sectional study was conducted of 643 women aged 19-48 years who presented for delivery at selected public hospitals and private traditional birth attendants from July-November 2011. Participants’ information and factors influencing antenatal attendance were collected using a structured questionnaire and antenatal records. Associations between these factors and adverse pregnancy outcomes were assessed using chi-square and logistic regression. Nineteen percent of the women experienced an adverse pregnancy outcome. For 49% of the women, cost influenced their antenatal attendance. Cost was associated with increased likelihood of a woman experiencing an adverse outcome (adjusted OR = 2.15; 95% CI = 1.16-3.99; p = 0.016). Also, women with >5 births had an increased likelihood of an adverse outcome compared with women with single deliveries (adjusted OR = 3.77; 95% CI = 1.50-9.53; p = 0.005). The prevalence of adverse outcomes was lower than previously reported (44.6% - 19%). Cost and distance were associated with adverse outcomes after adjusting for confounders. Cost and distance could be minimized through a wider application of the Ghana National Health Insurance Scheme. PMID:24206799

Adverse pregnancy outcomes in women with systemic lupus erythematosus from a multiethnic US cohort: LUMINA (LVI) [corrected].

PubMed

Andrade, R; Sanchez, M L; Alarcón, G S; Fessler, B J; Fernández, M; Bertoli, A M; Apte, M; Vilá, L M; Arango, A M; Reveille, J D

2008-01-01

To study the factors associated with an adverse pregnancy outcome in women with systemic lupus erythematosus (SLE). SLE women from LUMINA of Hispanic, African American and Caucasian ethnicity were studied. Adverse pregnancy outcome was a miscarriage or abortion (<20 weeks), a stillbirth (> or = 20) and/or a moderate to severe preterm-baby (<34 weeks); good outcome was either a mild preterm-baby (> or = 34 weeks) or a full-term baby [C-section or vaginal delivery (38-42 weeks)]. Pregnancies occurring after SLE diagnosis (TD) were included; pregnancy outcome was the unit of analyses. The relationship between selected variables and pregnancy outcomes was examined by univariable and multivariable analyses. Adverse outcomes occurred in 63.7% of 102 pregnancies. In the univariable analyses, Texan Hispanic and African American ethnicities, fewer years of education, higher number of ACR criteria, renal involvement, glucocorticoid exposure and the maximum dose of glucocorticoids used prior to the pregnancy outcome were associated with an adverse pregnancy outcome. Renal involvement was independently associated with an adverse pregnancy outcome [Odds ratio (OR)=5.219 (95% Confidence Interval (CI) 1.416-19.239, p=0.0131] as were the maximum dose of glucocorticoids used prior to the pregnancy outcome (OR=1.028; CI:1.002-1.054; p=0.0315) and fewer years of education (OR=1.204; CI:1.006-1.472; p=0.0437). Ethnicity was not retained in the multivariable model. Renal involvement, the maximum dose of glucocorticoids used prior to pregnancy and fewer years of education were associated with adverse pregnancy outcomes. These data have implications for the management of women with lupus planning to become pregnant.

Gastroschisis: antenatal sonographic predictors of adverse neonatal outcome.

PubMed

Page, Rachael; Ferraro, Zachary Michael; Moretti, Felipe; Fung, Karen Fung Kee

2014-01-01

The aim of this review was to identify clinically significant ultrasound predictors of adverse neonatal outcome in fetal gastroschisis. A quasi-systematic review was conducted in PubMed and Ovid using the key terms "gastroschisis," "predictors," "outcome," and "ultrasound." A total of 18 papers were included. The most common sonographic predictors were intra-abdominal bowel dilatation (IABD), intrauterine growth restriction (IUGR), and bowel dilatation not otherwise specified (NOS). Three ultrasound markers were consistently found to be statistically insignificant with respect to predicting adverse outcome including abdominal circumference, stomach herniation and dilatation, and extra-abdominal bowel dilatation (EABD). Gastroschisis is associated with several comorbidities, yet there is much discrepancy in the literature regarding which specific ultrasound markers best predict adverse neonatal outcomes. Future research should include prospective trials with larger sample sizes and use well-defined and consistent definitions of the adverse outcomes investigated with consideration given to IABD.

Association between chronic arsenic exposure and nutritional status among the women of child bearing age: a case-control study in Bangladesh.

PubMed

Milton, Abul H; Shahidullah, S M; Smith, Wayne; Hossain, Kazi S; Hasan, Ziaul; Ahmed, Kazi T

2010-07-01

The role of nutritional factors in arsenic metabolism and toxicity is yet to be fully elucidated. A low protein diet results in decreased excretion of DMA and increased tissue retention of arsenic in experimental studies. Malnourished women carry a higher risk of adverse pregnancy outcomes. Chronic exposure to high arsenic (>50 microg/L) through drinking water also increases the risk of adverse pregnancy outcomes. The synergistic effects (if any) of malnutrition and chronic arsenic exposure may worsen the adverse pregnancy outcomes. This population based case control study reports the association between chronic arsenic exposure and nutritional status among the rural women in Bangladesh. 348 cases (BMI < 18.5) and 360 controls (BMI 18.5-24.99) were recruited from a baseline survey conducted among 2,341 women. An excess risk for malnutrition was observed among the participants chronically exposed to higher concentrations of arsenic in drinking water after adjusting for potential confounders such as participant's age, religion, education, monthly household income and history of oral contraceptive pills. Women exposed to arsenic >50 microg/L were at 1.9 times (Odds Ratio = 1.9, 95% CI = 1.1-3.6) increased risk of malnutrition compared to unexposed. The findings of this study suggest that chronic arsenic exposure is likely to contribute to poor nutritional status among women of 20-45 years.

PUTATIVE ADVERSE OUTCOME PATHWAY FOR INHIBITON ...

EPA Pesticide Factsheets

The adverse outcome pathway (AOP) provides a framework for organizing knowledge to define links between a molecular initiating event (MIE) and an adverse outcome (AO) occurring at a higher level of biological organization, such as the individual or population. The AOP framework proceeds from a general (e.g., not chemical specific) molecular mode of action, designated as a MIE, through stepwise changes in biological status, defined as key events (KEs), to a final AO that can be used in risk assessment. Because aromatase-inhibiting pharmaceuticals are widely used to treat breast cancer patients, we explored the unintended consequences that might occur in fish exposed to these chemicals through wastewater discharge into the aquatic environment. Unlike mammals, fish have two isoforms of aromatase, one that predominates in the ovary (cyp19a1a) and a second (cyp19a1b) that prevails in the brain. Aromatase activity in fish brain can be 100 to 1000 times that in mammals and is associated with reproduction. We have developed a putative AOP for inhibition of brain aromatase in fish leading to reproductive dysfunction based on review of relevant literature and reproductive experiments with the marine fish cunner (Tautogolabrus adspersus) exposed to aromatase-inhibiting pharmaceuticals in the laboratory. The first KE in this AOP is a decrease in brain aromatase activity due to exposure to an aromatase inhibitor. KEs then progress through subsequent steps including decreas

A Comparison of the Effects of Three Intervention Approaches on Parental Self-Efficacy, Parenting Skills, and Parental Stress Levels of Impoverished Parents

ERIC Educational Resources Information Center

Rooney, MaryEllen

2012-01-01

The purpose of this study is to compare three intervention approaches that focused on alleviating some of the deleterious effects of poverty by building parental self-efficacy, increasing parenting skills, and decreasing parental stress levels in parents at-risk for negative child outcomes due to factors associated with adverse socioeconomic…

Risk Factors and Risk Stratification for Adverse Obstetrical Outcomes After Appendectomy or Cholecystectomy During Pregnancy.

PubMed

Sachs, Adam; Guglielminotti, Jean; Miller, Russell; Landau, Ruth; Smiley, Richard; Li, Guohua

2017-05-01

Identification of risk factors for adverse obstetrical outcomes after appendectomy and cholecystectomy during pregnancy is necessary for evidence-based risk reduction and adequate patient counseling. To identify risk factors for adverse obstetrical outcomes after appendectomy and cholecystectomy during pregnancy and stratify the risk of such outcomes. A cohort study was conducted using the Nationwide Inpatient Sample, a nationally representative sample of patients discharged from community hospitals in the United States, from January 1, 2003, to December 31, 2012. Multivariable analysis of risk factors for adverse obstetric outcomes was performed for 19 926 women undergoing appendectomy or cholecystectomy during pregnancy and a scoring system for such risk factors was developed. Data analysis was conducted from January 1, 2015, to July 31, 2016. A composite measure including 7 adverse obstetrical outcomes throughout pregnancy and occurring before hospital discharge. Of the 19 926 women (mean [SD] age, 26 [6] years) in the study, 1018 adverse obstetrical events were recorded in 953 pregnant women (4.8%). The 3 most frequent adverse events were preterm delivery (360 [35.4%]), preterm labor without preterm delivery (269 [26.4%]), and miscarriage (262 [25.7%]). The risk factors associated most strongly with an adverse obstetrical outcome included cervical incompetence (adjusted odds ratio, 24.29; 95% CI, 7.48-78.81), preterm labor during current pregnancy (adjusted odds ratio, 18.34; 95% CI, 4.95-67.96), vaginitis or vulvovaginitis (adjusted odds ratio, 5.17; 95% CI, 2.19-12.23), and sepsis (adjusted odds ratio, 3.39; 95% CI, 2.08-5.51). A scoring system based on statistically significant variables classified the study sample into 3 risk groups corresponding to predicted probabilities of adverse obstetrical outcomes of 2.5% (≤4 points), 8.2% (5-8 points), and 21.8% (≥9 points). Approximately 5% of women experience adverse obstetrical outcomes after appendectomy or cholecystectomy during pregnancy. The major risk factors for such outcomes are cervical incompetence, preterm labor during current pregnancy, vaginitis or vulvovaginitis, and sepsis.

Nitric Oxide Decreases Acute Kidney Injury and Stage 3 Chronic Kidney Disease after Cardiac Surgery.

PubMed

Lei, Chong; Berra, Lorenzo; Rezoagli, Emanuele; Yu, Binglan; Dong, Hailong; Yu, Shiqiang; Hou, Lihong; Chen, Min; Chen, Wensheng; Wang, Hongbing; Zheng, Qijun; Shen, Jie; Jin, Zhenxiao; Chen, Tao; Zhao, Rong; Christie, Emily; Sabbisetti, Venkata S; Nordio, Francesco; Bonventre, Joseph V; Xiong, Lize; Zapol, Warren M

2018-06-22

No medical intervention has been identified that decreases acute kidney injury and improves renal outcome at 1-year after cardiac surgery. To determine whether administration of nitric oxide reduces the incidence of post-operative acute kidney injury and improves long-term kidney outcomes after multiple cardiac valve replacement requiring prolonged cardiopulmonary bypass. 244 Patients undergoing elective, multiple valve replacement surgery mostly due to rheumatic fever were randomized to receive either nitric oxide (treatment) or nitrogen (control). Nitric oxide and nitrogen were administered via the gas exchanger during cardiopulmonary bypass and by inhalation for 24h post-operatively. Primary outcome: Oxidation of ferrous plasma oxyhemoglobin to ferric methemoglobin was associated to a reduced post-operative acute kidney injury from 64% (control group) to 50% (nitric oxide) (RR, 95% CI; 0.78, 0.62-0.97;P=0.014). At 90-days, transition to stage 3 chronic kidney disease was reduced from 33% in the controls to 21% in the treatment group (RR, 95%CI; 0.64, 0.41 - 0.99;P=0.024); and at 1-year, from 31% to 18% (RR, 95% CI; 0.59, 0.36 - 0.96;P=0.017). Nitric oxide treatment reduced the overall major adverse kidney events at 30-days (RR, 95% CI; 0.40, 0.18 - 0.92;P=0.016, 90-days (RR, 95% CI; 0.40, 0.17 - 0.92;P=0.015 and 1-year (RR, 95% CI; 0.47, 0.20-1.10;P=0.041). In patients undergoing multiple valve replacement and prolonged cardiopulmonary bypass, administration of nitric oxide decreased the incidence of acute kidney injury, transition to stage 3 chronic kidney disease and major adverse kidney events at 30-days, 90-days, and 1-year. Clinical trial registered with ClinicalTrials.gov (NCT01802619).

Exposure of Particulate Matters PM10 and PM2.5 to Pregnant Ladies during First Trimester and its Impact on Adverse Birth Outcomes in Delhi, India

NASA Astrophysics Data System (ADS)

Kumar, S.; Goyal, P.

2015-12-01

The incessant exposure to criteria air pollutants at different level of concentrations is associated with adverse birth outcomes. The present study advocates the importance of the early period of pregnancy (first trimester) for association between growth in term of small gestational age (SGA) and birth weight (BW) with PM2.5 and PM10 for megacity Delhi. The association of PM10 and PM2.5 average concentration, SGA, pre term birth (PTB) and lower birth weight (LBW < 2500g or 5.5 pounds) outcomes have been investigated among 1749 live births in a large hospital during the year 2012 New Delhi, India. The air pollutants PM2.5 and PM10 have been used in single pollutant logistic regression models to estimate odds ratios (OR) for these outcomes. Growth in term of SGA is associated with PM2.5 levels (OR = 0.99, confidence interval (CI) = 0.99 - 1.0) and PM10 levels (OR= 0.99, CI= 0.99 - 1.001) in the first trimester of pregnancy. Birth weight outcome in terms of lower birth weight (LBW) has been found to be significantly associated with PM2.5 (OR= 0.99, CI = 0.98 - 1.00) exposure in the first trimester. A very significant decrease of 0.1% has been observed in growth of infant in terms of SGA with per 10 mg/m3 increase in PM2.5. Also, 0.1 % statistically significant adverse association of BW in terms of LBW has been found with per 10 mg/m3 increased vulnerability of PM2.5 during first trimester of gestation.

Association of Nurse-to-Patient Ratio with mortality and preventable complications following aortic valve replacement.

PubMed

Arkin, Nicole; Lee, Peter H U; McDonald, Kathryn; Hernandez-Boussard, Tina

2014-03-01

To examine hospital resources associated with patient outcomes for aortic valve replacement (AVR), including inpatient adverse events and mortality. We used the Nationwide Inpatient Sample to identify AVR procedures from 1998 to 2010 and the American Hospital Association Annual Survey to augment hospital characteristics. Primary outcomes included mortality and the development of adverse events, identified using standardized patient safety indicators (PSI). Patient and hospital characteristics associated with PSI development were evaluated using univariate and multivariate analyses. An estimated 410,157 AVRs at 5009 hospitals were performed in the US between 1998 and 2010. The number of procedures grew annually by 4.72% (p=0.0003) in high volume hospitals, 4.48% in medium volume hospitals (p<0.0001), and 2.03% in low volume hospitals (p=0.154). Mortality was highest in low volume hospitals, 4.70%, decreased from 4.14% to 3.73% in medium and high volume hospitals, respectively (p=0.0002). Rates of PSIs did not vary significantly across volume terciles (p=0.254). Multivariate logistic regression analysis showed low volume hospitals had increased risk of mortality as compared with high volume hospitals (odds ratio [OR]: 1.42; 95% confidence interval [CI]: 1.01 to 2.00), while hospital volume was not associated with adverse events. PSI development was associated with small hospitals as compared with large (OR: 1.63, 95% CI: 1.16 to 2.28) and inversely associated with higher nurse-to-patient ratio (OR: 0.94, 95% CI: 0.90 to 0.99). The volume-outcomes relationship was associated with mortality outcomes but not postoperative complications. We identified structural differences in hospital size, nurses-to-patient ratio, and nursing skill level indicative of high quality outcomes. © 2014 Wiley Periodicals, Inc.

Dependence in prestroke mobility predicts adverse outcomes among patients with acute ischemic stroke.

PubMed

Dallas, Mary I; Rone-Adams, Shari; Echternach, John L; Brass, Lawrence M; Bravata, Dawn M

2008-08-01

Stroke survivors are commonly dependent in activities of daily living; however, the relation between prestroke mobility impairment and poststroke outcomes is poorly understood. The primary objective of this study was to evaluate the association between prestroke mobility impairment and 4 poststroke outcomes. The secondary objective was to evaluate the association between prestroke mobility impairment and a plan for physical therapy. This was a secondary analysis of the National Stroke Project data, a retrospective cohort of Medicare beneficiaries who were hospitalized with an acute ischemic stroke (1998 to 2001). Logistic-regression modeling was used to examine the adjusted association between prestroke mobility impairment with patient outcomes and a plan for physical therapy. Among the 67,445 patients hospitalized with an ischemic stroke, 6% were dependent in prestroke mobility. Prestroke mobility dependence was independently associated with an increased odds of poststroke mobility impairment (odds ratio [OR]=9.9; 95% CI, 9.0 to 10.8); in-hospital mortality (OR=2.4; 95% CI, 2.2 to 2.7); discharge to a skilled nursing facility (OR=3.5; 95% CI, 3.2 to 3.8); and the combination of in-hospital death or discharge to a skilled nursing facility (OR=3.5; 95% CI, 3.3 to 3.8). Prestroke mobility dependence was independently associated with a decreased odds of having a plan for physical therapy (OR=0.79; 95% CI, 0.73 to 0.85). These data, obtained from a large, geographically diverse cohort from the United States, demonstrate a strong association between dependence in prestroke mobility and adverse outcomes among elderly stroke patients. Clinicians should screen patients for prestroke mobility impairment to identify patients at greatest risk for adverse events.

Cumulative stress and autonomic dysregulation in a community sample.

PubMed

Lampert, Rachel; Tuit, Keri; Hong, Kwang-Ik; Donovan, Theresa; Lee, Forrester; Sinha, Rajita

2016-05-01

Whether cumulative stress, including both chronic stress and adverse life events, is associated with decreased heart rate variability (HRV), a non-invasive measure of autonomic status which predicts poor cardiovascular outcomes, is unknown. Healthy community dwelling volunteers (N = 157, mean age 29 years) participated in the Cumulative Stress/Adversity Interview (CAI), a 140-item event interview measuring cumulative adversity including major life events, life trauma, recent life events and chronic stressors, and underwent 24-h ambulatory ECG monitoring. HRV was analyzed in the frequency domain and standard deviation of NN intervals (SDNN) calculated. Initial simple regression analyses revealed that total cumulative stress score, chronic stressors and cumulative adverse life events (CALE) were all inversely associated with ultra low-frequency (ULF), very low-frequency (VLF) and low-frequency (LF) power and SDNN (all p < 0.05). In hierarchical regression analyses, total cumulative stress and chronic stress each was significantly associated with SDNN and ULF even after the highly significant contributions of age and sex, with no other covariates accounting for additional appreciable variance. For VLF and LF, both total cumulative stress and chronic stress significantly contributed to the variance alone but were not longer significant after adjusting for race and health behaviors. In summary, total cumulative stress, and its components of adverse life events and chronic stress were associated with decreased cardiac autonomic function as measured by HRV. Findings suggest one potential mechanism by which stress may exert adverse effects on mortality in healthy individuals. Primary preventive strategies including stress management may prove beneficial.

Cumulative stress and autonomic dysregulation in a community sample

PubMed Central

Lampert, Rachel; Tuit, Keri; Hong, Kwang-ik; Donovan, Theresa; Lee, Forrester; Sinha, Rajita

2016-01-01

Whether cumulative stress, including both chronic stress and adverse life events, is associated with decreased heart rate variability (HRV), a non-invasive measure of autonomic status which predicts poor cardiovascular outcomes, is unknown. Healthy community dwelling volunteers, (N= 157, mean age 29 years) participated in the Cumulative Stress/Adversity Interview, (CAI) a 140-item event interview measuring cumulative adversity including major life events, life trauma, recent life events and chronic stressors, and underwent 24 hour ambulatory ECG monitoring. HRV was analyzed in the frequency domain and standard deviation of NN intervals (SDNN) calculated. Initial simple regression analyses revealed that total cumulative stress score, chronic stressors, and cumulative adverse life events (CALE) were all inversely associated with ultra low frequency (ULF), very low frequency (VLF), and low frequency (LF) power and SDNN (all p<0.05). In hierarchical regression analyses, total cumulative stress and chronic stress each was significantly associated with SDNN and ULF even after the high significant contribution of age and sex, with no other covariates accounting for additional appreciable variance. For VLF and LF, both total cumulative stress and chronic stress significantly contributed to the variance were no longer significant after adjusting for race and health behaviors. (p’s<.05). In summary, total cumulative stress, and its components of adverse life events and chronic stress were associated with decreased cardiac autonomic function as measured by HRV. Findings suggest one potential mechanism by which stress may exert adverse effects on mortality in healthy individuals. Primary preventive strategies including stress management may prove beneficial. PMID:27112063

Cytomegalovirus seroprevalence in pregnant women and association with adverse pregnancy/neonatal outcomes in Jiangsu Province, China.

PubMed

Zhang, Shu; Hu, Lingqing; Chen, Jie; Xu, Biyun; Zhou, Yi-Hua; Hu, Yali

2014-01-01

In this study, we aimed to determine the provincial population-based seroprevalence in pregnant women and to further explore the association of maternal CMV infection status and adverse pregnancy/neonatal/growth outcomes in Jiangsu, China. In this case-control study, the sera from 527 pregnant women with adverse pregnancy/neonatal outcomes and 496 mothers of healthy infants in Jiangsu Province, collected at gestation age of 15-20 weeks, were tested for anti-CMV IgG, IgM and IgG avidity. Adverse pregnancy/neonatal outcomes were identified based on pregnancy/neonatal outcomes. The overall seroprevalence of anti-CMV IgG was 98.7%, with 99.4% and 98.0% in the case and control groups, respectively (P = 0.039). The prevalence of anti-CMV IgG+/IgM+, was higher in the case group than that in the control group (3.8% vs. 1.6%, P = 0.033). Anti-CMV IgG avidity assay showed that none in the control group were primarily infected, but five (0.9%) in the case group underwent primary infection (P = 0.084); all five infants of these women presented severe adverse neonatal/growth outcomes. Exact logistic regression analysis showed that anti-CMV IgG+/IgM+ was associated with adverse pregnancy/neonatal/growth outcomes (aOR = 2.44, 95% CI 1.01-6.48, P = 0.047). Maternal low education level and prior abnormal pregnancies also were risk factors for adverse pregnancy/neonatal outcomes. In populations with very high prevalence of latent CMV infection, active maternal CMV infection during pregnancy might be a risk factor for adverse pregnancy/neonatal outcomes.

Cytomegalovirus Seroprevalence in Pregnant Women and Association with Adverse Pregnancy/Neonatal Outcomes in Jiangsu Province, China

PubMed Central

Chen, Jie; Xu, Biyun; Zhou, Yi-Hua; Hu, Yali

2014-01-01

Background In this study, we aimed to determine the provincial population-based seroprevalence in pregnant women and to further explore the association of maternal CMV infection status and adverse pregnancy/neonatal/growth outcomes in Jiangsu, China. Methods In this case-control study, the sera from 527 pregnant women with adverse pregnancy/neonatal outcomes and 496 mothers of healthy infants in Jiangsu Province, collected at gestation age of 15–20 weeks, were tested for anti-CMV IgG, IgM and IgG avidity. Adverse pregnancy/neonatal outcomes were identified based on pregnancy/neonatal outcomes. Results The overall seroprevalence of anti-CMV IgG was 98.7%, with 99.4% and 98.0% in the case and control groups, respectively (P = 0.039). The prevalence of anti-CMV IgG+/IgM+, was higher in the case group than that in the control group (3.8% vs. 1.6%, P = 0.033). Anti-CMV IgG avidity assay showed that none in the control group were primarily infected, but five (0.9%) in the case group underwent primary infection (P = 0.084); all five infants of these women presented severe adverse neonatal/growth outcomes. Exact logistic regression analysis showed that anti-CMV IgG+/IgM+ was associated with adverse pregnancy/neonatal/growth outcomes (aOR = 2.44, 95% CI 1.01–6.48, P = 0.047). Maternal low education level and prior abnormal pregnancies also were risk factors for adverse pregnancy/neonatal outcomes. Conclusions In populations with very high prevalence of latent CMV infection, active maternal CMV infection during pregnancy might be a risk factor for adverse pregnancy/neonatal outcomes. PMID:25211647

Development of Quantitative Adverse Outcome Pathways Using Health-Protective Assumptions to Fill Data Gaps

EPA Science Inventory

In an adverse outcome pathway (AOP), the target site dose participates in a molecular initiating event (MIE), which in turn triggers a sequence of key events leading to an adverse outcome (AO). Quantitative AOPs (QAOP) are needed if AOP characterization is to address risk as well...

Application of adverse outcome pathways (AOPs) in human health and ecotoxicology capturing divergent consequences of conserved molecular initiating events via AOP networks

EPA Science Inventory

The adverse outcome pathway (AOP) framework was developed to help organize and disseminate existing knowledge concerning the means through which specific perturbations of biological pathways can lead to adverse outcomes considered relevant to risk-based regulatory decision-making...

Application of Adverse Outcome Pathways (AOPs) in Human Health and Ecotoxicology Capturing Divergent Consequences of Conserved Molecular Initiating Events via AOP Networks (Presentation)

EPA Science Inventory

The adverse outcome pathway (AOP) framework was developed to help organize and disseminate existing knowledge concerning the means through which specific perturbations of biological pathways can lead to adverse outcomes considered relevant to risk-based regulatory decision-making...

Computationally predicted Adverse Outcome Pathway networks for liver-related diseases using publicly available data sources: Case studies and lessons learned

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework summarizes key information about mechanistic events leading to an adverse health or ecological outcome. In recent years computationally predicted AOPs (cpAOP) making use of publicly available data have been proposed as a means of accele...

A core outcome set for clinical trials in acute diarrhoea.

PubMed

Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; Lo Vecchio, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania

2015-04-01

Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects. The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Development of a Screening Tool for Predicting Adverse Outcomes of Gestational Diabetes Mellitus

PubMed Central

Park, Jee Soo; Kim, Deok Won; Kwon, Ja-Young; Park, Yong Won; Kim, Young Han; Cho, Hee Young

2016-01-01

Abstract Gestational diabetes mellitus (GDM) is a common disease in pregnancy causing maternal and fetal complications. To prevent these adverse outcomes, optimal screening and diagnostic criteria must be adequate, timely, and efficient. This study suggests a novel approach that is practical, efficient, and patient- and clinician-friendly in predicting adverse outcomes of GDM. The authors conducted a retrospective cohort study via medical record review of patients admitted between March 2001 and April 2013 at the Severance Hospital, Seoul, South Korea. Patients diagnosed by a conventional 2-step method were evaluated according to the presence of adverse outcomes (neonatal hypoglycemia, hyperbilirubinemia, and hyperinsulinemia; admission to the neonatal intensive care unit; large for gestational age; gestational insulin therapy; and gestational hypertension). Of 802 women who had an abnormal 50-g, 1-hour glucose challenge test, 306 were diagnosed with GDM and 496 did not have GDM (false-positive group). In the GDM group, 218 women (71.2%) had adverse outcomes. In contrast, 240 women (48.4%) in the false-positive group had adverse outcomes. Women with adverse outcomes had a significantly higher body mass index (BMI) at entry (P = 0.03) and fasting blood glucose (FBG) (P = 0.03). Our logistic regression model derived from 2 variables, BMI at entry and FBG, predicted GDM adverse outcome with an area under the curve of 0.642, accuracy of 61.3%, sensitivity of 57.2%, and specificity of 66.9% compared with the conventional 2-step method with an area under the curve of 0.610, accuracy of 59.1%, sensitivity of 47.6%, and specificity of 74.4%. Our model performed better in predicting GDM adverse outcomes than the conventional 2-step method using only BMI at entry and FBG. Moreover, our model represents a practical, inexpensive, efficient, reproducible, easy, and patient- and clinician-friendly approach. PMID:26735528

Development of a Screening Tool for Predicting Adverse Outcomes of Gestational Diabetes Mellitus: A Retrospective Cohort Study.

PubMed

Park, Jee Soo; Kim, Deok Won; Kwon, Ja-Young; Park, Yong Won; Kim, Young Han; Cho, Hee Young

2016-01-01

Gestational diabetes mellitus (GDM) is a common disease in pregnancy causing maternal and fetal complications. To prevent these adverse outcomes, optimal screening and diagnostic criteria must be adequate, timely, and efficient. This study suggests a novel approach that is practical, efficient, and patient- and clinician-friendly in predicting adverse outcomes of GDM. The authors conducted a retrospective cohort study via medical record review of patients admitted between March 2001 and April 2013 at the Severance Hospital, Seoul, South Korea. Patients diagnosed by a conventional 2-step method were evaluated according to the presence of adverse outcomes (neonatal hypoglycemia, hyperbilirubinemia, and hyperinsulinemia; admission to the neonatal intensive care unit; large for gestational age; gestational insulin therapy; and gestational hypertension). Of 802 women who had an abnormal 50-g, 1-hour glucose challenge test, 306 were diagnosed with GDM and 496 did not have GDM (false-positive group). In the GDM group, 218 women (71.2%) had adverse outcomes. In contrast, 240 women (48.4%) in the false-positive group had adverse outcomes. Women with adverse outcomes had a significantly higher body mass index (BMI) at entry (P = 0.03) and fasting blood glucose (FBG) (P = 0.03). Our logistic regression model derived from 2 variables, BMI at entry and FBG, predicted GDM adverse outcome with an area under the curve of 0.642, accuracy of 61.3%, sensitivity of 57.2%, and specificity of 66.9% compared with the conventional 2-step method with an area under the curve of 0.610, accuracy of 59.1%, sensitivity of 47.6%, and specificity of 74.4%. Our model performed better in predicting GDM adverse outcomes than the conventional 2-step method using only BMI at entry and FBG. Moreover, our model represents a practical, inexpensive, efficient, reproducible, easy, and patient- and clinician-friendly approach.

Adverse Childhood Experiences and Adult Criminality: How Long Must We Live before We Possess Our Own Lives?

PubMed Central

Reavis, James A; Looman, Jan; Franco, Kristina A; Rojas, Briana

2013-01-01

Background: Empirical research associated with the Kaiser Permanente and Centers for Disease Control and Prevention Adverse Childhood Experiences (ACE) Study has demonstrated that ACE are associated with a range of negative outcomes in adulthood, including physical and mental health disorders and aggressive behavior. Methods: Subjects from 4 different offender groups (N = 151) who were referred for treatment at an outpatient clinic in San Diego, CA, subsequent to conviction in criminal court, completed the ACE Questionnaire. Groups (nonsexual child abusers, domestic violence offenders, sexual offenders, and stalkers) were compared on the incidence of ACE, and comparisons were made between the group offenders and a normative sample. Results: Results indicated that the offender group reported nearly four times as many adverse events in childhood than an adult male normative sample. Eight of ten events were found at significantly higher levels among the criminal population. In addition, convicted sexual offenders and child abusers were more likely to report experiencing sexual abuse in childhood than other offender types. Conclusions: On the basis of a review of the literature and current findings, criminal behavior can be added to the host of negative outcomes associated with scores on the ACE Questionnaire. Childhood adversity is associated with adult criminality. We suggest that to decrease criminal recidivism, treatment interventions must focus on the effects of early life experiences. PMID:23704843

Meningitis With a Negative Cerebrospinal Fluid Gram Stain in Adults: Risk Classification for an Adverse Clinical Outcome

PubMed Central

Khoury, Nabil T.; Hossain, Md Monir; Wootton, Susan H.; Salazar, Lucrecia; Hasbun, Rodrigo

2012-01-01

Objective To derive and validate a risk score for an adverse clinical outcome in adults with meningitis and a negative cerebrospinal fluid (CSF) Gram stain. Patients and Methods We conducted a retrospective study of 567 adults from Houston, Texas, with meningitis evaluated between January 1, 2005, and January 1, 2010. The patients were divided into derivation (N=292) and validation (N=275) cohorts. An adverse clinical outcome was defined as a Glasgow Outcome Scale score of 4 or less. Results Of the 567 patients, 62 (11%) had an adverse clinical outcome. A predictive model was created using 3 baseline variables that were independently associated with an adverse clinical outcome (P<.05): age greater than 60 years, abnormal findings on neurologic examination (altered mental status, focal neurologic deficits, or seizures), and CSF glucose level of less than 2.4975 mmol/L (to convert CSF glucose to mmol/L, multiply by 0.05551). The model classified patients into 2 categories of risk for an adverse clinical outcome—derivation sample: low risk, 0.6% and high risk, 32.8%; P<.001; and validation sample: low risk, 0.5% and high risk, 21.1%; P<.001. Conclusion Adults with meningitis and a negative CSF Gram stain can be accurately stratified for the risk of an adverse clinical outcome using clinical variables available at presentation. PMID:23218086

Can differences in obstetric outcomes be explained by differences in the care provided? The MFMU Network APEX study.

PubMed

Grobman, William A; Bailit, Jennifer L; Rice, Madeline Murguia; Wapner, Ronald J; Varner, Michael W; Thorp, John M; Leveno, Kenneth J; Caritis, Steve N; Iams, Jay D; Tita, Alan T; Saade, George; Sorokin, Yoram; Rouse, Dwight J; Tolosa, Jorge E; Van Dorsten, J Peter

2014-08-01

The purpose of this study was to determine whether hospital differences in the frequency of adverse obstetric outcomes are related to differences in care. The Assessment of Perinatal EXcellence cohort comprises 115,502 women and their neonates who were born in 25 hospitals in the United States between March 2008 and February 2011. Hierarchical logistic regression was used to quantify the amount of variation in postpartum hemorrhage, peripartum infection, severe perineal laceration, and a composite adverse neonatal outcome among hospitals that is explained by differences in patient characteristics, hospital characteristics, and obstetric care provided. The study included 115,502 women. For most outcomes, 20-40% of hospital differences in outcomes were related to differences in patient populations. After adjusting for patient-, provider-, and hospital-level factors, multiple care processes were associated with the predefined adverse outcomes; however, these care processes did not explain significant variation in the frequency of adverse outcomes among hospitals. Ultimately, 50-100% of the interhospital variation in outcomes was unexplained. Hospital differences in the frequency of adverse obstetric outcomes could not be explained by differences in frequency of types of care provided. Copyright © 2014 Mosby, Inc. All rights reserved.

Classification of individual well-being scores for the determination of adverse health and productivity outcomes in employee populations.

PubMed

Shi, Yuyan; Sears, Lindsay E; Coberley, Carter R; Pope, James E

2013-04-01

Adverse health and productivity outcomes have imposed a considerable economic burden on employers. To facilitate optimal worksite intervention designs tailored to differing employee risk levels, the authors established cutoff points for an Individual Well-Being Score (IWBS) based on a global measure of well-being. Cross-sectional associations between IWBS and adverse health and productivity outcomes, including high health care cost, emergency room visits, short-term disability days, absenteeism, presenteeism, low job performance ratings, and low intentions to stay with the employer, were studied in a sample of 11,702 employees from a large employer. Receiver operating characteristics curves were evaluated to detect a single optimal cutoff value of IWBS for predicting 2 or more adverse outcomes. More granular segmentation was achieved by computing relative risks of each adverse outcome from logistic regressions accounting for sociodemographic characteristics. Results showed strong and significant nonlinear associations between IWBS and health and productivity outcomes. An IWBS of 75 was found to be the optimal single cutoff point to discriminate 2 or more adverse outcomes. Logistic regression models found abrupt reductions of relative risk also clustered at IWBS cutoffs of 53, 66, and 88, in addition to 75, which segmented employees into high, high-medium, medium, low-medium, and low risk groups. To determine validity and generalizability, cutoff values were applied in a smaller employee population (N=1853) and confirmed significant differences between risk groups across health and productivity outcomes. The reported segmentation of IWBS into discrete cohorts based on risk of adverse health and productivity outcomes should facilitate well-being comparisons and worksite interventions.

Antenatal care attendance, a surrogate for pregnancy outcome? The case of Kumasi, Ghana.

PubMed

Asundep, Ntui N; Jolly, Pauline E; Carson, April; Turpin, Cornelius A; Zhang, Kui; Tameru, Berhanu

2014-07-01

Antenatal care (ANC) has been shown to influence infant and maternal outcomes. WHO recommends 4 ANC visits for uncomplicated pregnancies. However, pregnant women in Ghana are required to attend 8-13 antenatal visits. We investigated the association of ANC attendance with adverse pregnancy outcomes (defined as low infant birth weight, stillbirth, preterm delivery or small for gestational age). A quantitative cross-sectional study was conducted on 629 women, age 19-48 years who presented for delivery at two selected public hospitals and 16 traditional birth attendants from July to November 2011. Socio-demographic and antenatal information were collected using a structured questionnaire. ANC attendance, medical and obstetric/gynecological history were abstracted from maternal antenatal records. Data were analyzed using Chi square and logistic regression. Twenty-two percent of the women experienced an adverse outcome. Eleven percent of the women attended <4 ANC visits. In an unadjusted model, these women had an increased likelihood of experiencing an adverse outcome (OR 2.27; 95% CI 1.30-3.94; p = 0.0038). High parity (>5 children) was also associated with adverse birth outcomes. Women screened for syphilis or use of insecticide-treated bed nets had a 40 and 36% (p = 0.0447 and p = 0.0293) reduced likelihood of experiencing an adverse pregnancy outcome respectively. After adjusting for confounders, attending <4 antenatal visits was associated with adverse pregnancy outcome compared with ≥4 ANC visits (Adjusted OR 2.55; 95% CI 1.16-5.63; p = 0.0202). Attending <4 antenatal visits and high parity were associated with adverse pregnancy outcomes for uncomplicated pregnancies.

Implications of failure to achieve a result from prenatal maternal serum cell-free DNA testing: a historical cohort study.

PubMed

Chan, N; Smet, M-E; Sandow, R; da Silva Costa, F; McLennan, A

2017-11-01

To investigate the pregnancy outcomes in a cohort of women who failed to obtain a result in non-invasive prenatal testing (NIPT). Historical cohort study. A multicentre private practice in Sydney, Australia. Women who failed to obtain a result from NIPT (n = 131). The maternal characteristics, antenatal investigations and pregnancy outcomes for these women were compared with those who obtained a result at the same practice and to the general Australian obstetric population. Antenatal investigations: pregnancy-associated plasma protein-A (PAPP-A), free β-human chorionic gonadotrophin (β-hCG), placental growth factor (PlGF), uterine artery pulsatility index (PI), mean arterial pressure (MAP). Pregnancy outcomes: chromosomal abnormality, pre-eclampsia, gestational diabetes, small-for-gestational-age (SGA), preterm delivery. Only 1.1% of NIPT samples failed to return a result. This cohort was significantly older and had significantly increased weight compared with the general Australian obstetric population. Pregnancy outcomes were available for 94% of the cohort. There were significantly higher rates of chromosomal aneuploidies (6.5% versus 0.2%, P < 0.0001), pre-eclampsia (11% versus 1.5%, P < 0.0001) and gestational diabetes (23% versus 7.5%, P < 0.0001) compared with the general obstetric population. Rates of preterm delivery and SGA were elevated but did not reach significance. Antenatal investigations demonstrated decreased PAPP-A MoM (0.75 versus 1.14, P < 0.0001), decreased free β-hCG (0.71 versus 1.01, P < 0.0001) and increased uterine artery PI (1.79 versus 1.65, P = 0.02). Women who fail to obtain a result from NIPT are at increased risk of adverse pregnancy outcomes, in particular chromosomal aneuploidy, gestational diabetes and pre-eclampsia. None received. Women who fail to obtain a result from cell-free DNA NIPT are at increased risk of adverse pregnancy outcomes. © 2017 Royal College of Obstetricians and Gynaecologists.

The Association between Rural-Urban Continuum, Maternal Education and Adverse Birth Outcomes in Quebec, Canada

ERIC Educational Resources Information Center

Auger, Nathalie; Authier, Marie-Andree; Martinez, Jerome; Daniel, Mark

2009-01-01

Context: Rural relative to urban area and low socioeconomic status (SES) are associated with adverse birth outcomes. Whether a graded association of increasing magnitude is present across the urban-rural continuum, accounting for SES, is unclear. We examined the association between rural-urban continuum, SES and adverse birth outcomes. Methods:…

Renal outcomes and dietary potassium: the overshadowed electrolyte?

PubMed

Jablonski, Kristen L; Kendrick, Jessica B

2014-12-01

Smyth et al. examined the association between urinary sodium and potassium excretion and adverse renal outcomes in adults at high cardiovascular risk. They found no association between urinary sodium excretion and adverse renal outcomes, but a reduced odds of adverse renal outcomes with higher urinary potassium excretion. It will be important to ascertain whether this finding holds true in individuals free from vascular disease and diabetes, as well as in patients with chronic kidney disease.

Heterogeneity and the Effect of Mental Health Parity Mandates on the Labor Market*

PubMed Central

Andersen, Martin

2015-01-01

Health insurance benefit mandates are believed to have adverse effects on the labor market, but efforts to document such effects for mental health parity mandates have had limited success. I show that one reason for this failure is that the association between parity mandates and labor market outcomes vary with mental distress. Accounting for this heterogeneity, I find adverse labor market effects for non-distressed individuals, but favorable effects for moderately distressed individuals and individuals with a moderately distressed family member. On net, I conclude that the mandates are welfare increasing for moderately distressed workers and their families, but may be welfare decreasing for non-distressed individuals. PMID:26210944

An elevated gap between admission and A1C-derived average glucose levels is associated with adverse outcomes in diabetic patients with pyogenic liver abscess.

PubMed

Liao, Wen-I; Sheu, Wayne Huey-Herng; Chang, Wei-Chou; Hsu, Chin-Wang; Chen, Yu-Long; Tsai, Shih-Hung

2013-01-01

To assess whether chronic glycemic control and stress-induced hyperglycemia, determined by the gap between admission glucose levels and A1C-derived average glucose (ADAG) levels adversely affects outcomes in diabetic patients with pyogenic liver abscess (PLA). Clinical, laboratory, and multi-detector computed tomography (MDCT) findings of 329 PLA patients (2004-2010) were retrospectively reviewed. HbA1C levels were used to determine long-term glycemic control status, which were then converted to estimated average glucose values. For the gap between admission glucose levels and ADAG levels, we used receiver operating characteristic (ROC) curve to determine the optimal cut-off values predicting adverse outcomes. Univariate and multivariate logistic regressions were used to identify predictors of adverse outcomes. Diabetic PLA patients with poorer glycemic control had significantly higher Klebsiella pneumoniae (KP) infection rates, lower albumin levels, and longer hospital stays than those with suboptimal and good glycemic control. The ROC curve showed that a glycemic gap of 72 mg/dL was the optimal cut-off value for predicting adverse outcomes and showed a 22.3% relative increase in adverse outcomes compared with a glycemic gap<72 mg/dL. Multivariate analysis revealed that an elevated glycemic gap≥72 mg/dL was important predictor of adverse outcomes. A glycemic gap≥72 mg/dL, rather than admission hyperglycemia or chronic glycemic control, was significantly correlated with adverse outcomes in diabetic PLA patients. Poorer chronic glycemic control in diabetic PLA patients is associated with high incidence of KP infection, hypoalbuminemia and longer hospital stay.

Evaluating and ranking threats to the long-term persistence of polar bears

USGS Publications Warehouse

Atwood, Todd C.; Marcot, Bruce G.; Douglas, David C.; Amstrup, Steven C.; Rode, Karyn D.; Durner, George M.; Bromaghin, Jeffrey F.

2015-01-01

The polar bear (Ursus maritimus) was listed as a globally threatened species under the U.S. Endangered Species Act (ESA) in 2008, mostly due to the significant threat to their future population viability from rapidly declining Arctic sea ice. A core mandate of the ESA is the development of a recovery plan that identifies steps to maintain viable populations of a listed species. A substantive evaluation of the relative influence of putative threats to population persistence is helpful to recovery planning. Because management actions must often be taken in the face of substantial information gaps, a formalized evaluation hypothesizing potential stressors and their relationships with population persistence can improve identification of relevant conservation actions. To this end, we updated a Bayesian network model previously used to forecast the future status of polar bears worldwide. We used new information on actual and predicted sea ice loss and polar bear responses to evaluate the relative influence of plausible threats and their mitigation through management actions on the persistence of polar bears in four ecoregions. We found that polar bear outcomes worsened over time through the end of the century under both stabilized and unabated greenhouse gas (GHG) emission pathways. Under the unabated pathway (i.e., RCP 8.5), the time it took for polar bear populations in two of four ecoregions to reach a dominant probability of greatly decreased was hastened by about 25 years. Under the stabilized GHG emission pathway (i.e., RCP 4.5), where GHG emissions peak around the year 2040, the polar bear population in the Archipelago Ecoregion of High Arctic Canada never reached a dominant probability of greatly decreased, reinforcing earlier suggestions of this ecoregion’s potential to serve as a long-term refugium. The most influential drivers of adverse polar bear outcomes were declines to overall sea ice conditions and to the marine prey base. Improved sea ice conditions substantively lowered the probability of a decreased or greatly decreased outcome, while an elevated marine prey base was slightly less influential in lowering the probability of a decreased or greatly decreased outcome. Stressors associated with in situ human activities exerted considerably less influence on population outcomes. Reduced mortality from hunting and defense of life and property interactions resulted inmodest declines in the probability of a decreased or greatly decreased population outcome. Minimizing other stressors such as trans-Arctic shipping, oil and gas exploration, and point-source pollution had negligible effects on polar bear outcomes, but that could be attributed to uncertainties in the ecological relevance of those specific stressors. Our findings suggest adverse consequences of loss of sea ice habitat become more pronounced as the summer ice-free period lengthens beyond 4 months, which could occur in portions of the Arctic by the middle of this century under the unabated pathway. The long-term persistence of polar bears may be achieved through ameliorating the loss of sea ice habitat, which will likely require stabilizing CO2emissions at or below the ceiling represented by RCP 4.5. Management of other stressors may serve to slow the transition of polar bear populations to progressively worsened outcomes, and improve the prospects of persistence, pending GHG mitigation.

Prostate cancer outcomes in France: treatments, adverse effects and two-year mortality

PubMed Central

2014-01-01

Background This very large population-based study investigated outcomes after a diagnosis of prostate cancer (PCa) in terms of mortality rates, treatments and adverse effects. Methods Among the 11 million men aged 40 years and over covered by the general national health insurance scheme, those with newly managed PCa in 2009 were followed for two years based on data from the national health insurance information system (SNIIRAM). Patients were identified using hospitalisation diagnoses and specific refunds related to PCa and PCa treatments. Adverse effects of PCa treatments were identified by using hospital diagnoses, specific procedures and drug refunds. Results The age-standardised two-year all-cause mortality rate among the 43,460 men included in the study was 8.4%, twice that of all men aged 40 years and over. Among the 36,734 two-year survivors, 38% had undergone prostatectomy, 36% had been treated by hormone therapy, 29% by radiotherapy, 3% by brachytherapy and 20% were not treated. The frequency of treatment-related adverse effects varied according to age and type of treatment. Among men between 50 and 69 years of age treated by prostatectomy alone, 61% were treated for erectile dysfunction and 24% were treated for urinary disorders. The frequency of treatment for these disorders decreased during the second year compared to the first year (erectile dysfunction: 41% vs 53%, urinary disorders: 9% vs 20%). The frequencies of these treatments among men treated by external beam radiotherapy alone were 7% and 14%, respectively. Among men between 50 and 69 years with treated PCa, 46% received treatments for erectile dysfunction and 22% for urinary disorders. For controls without PCa but treated surgically for benign prostatic hyperplasia, these frequencies were 1.5% and 6.0%, respectively. Conclusions We report high survival rates two years after a diagnosis of PCa, but a high frequency of PCa treatment-related adverse effects. These frequencies remain underestimated, as they are based on treatments for erectile dysfunction and urinary disorders and do not reflect all functional outcomes. These results should help urologists and general practitioners to inform their patients about outcomes at the time of screening and diagnosis, and especially about potential treatment-related adverse effects. PMID:24927850

Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

PubMed

Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

2013-03-01

Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

Comparison of combined leflunomide and low-dose corticosteroid therapy with full-dose corticosteroid monotherapy for progressive IgA nephropathy.

PubMed

Min, Lulin; Wang, Qin; Cao, Liou; Zhou, Wenyan; Yuan, Jiangzi; Zhang, Minfang; Che, Xiajing; Mou, Shan; Fang, Wei; Gu, Leyi; Zhu, Mingli; Wang, Ling; Yu, Zanzhe; Qian, Jiaqi; Ni, Zhaohui

2017-07-18

IgA nephropathy is the most common primary glomerulonephritis and one of the leading causes of end-stage renal disease. We performed a randomized, controlled, prospective, open-label trial to determine whether leflunomide combined with low-dose corticosteroid is safe and effective for the treatment of progressive IgA nephropathy, as compared to full-dose corticosteroid monotherapy. Biopsy-proved primary IgA nephropathy patients with an estimated glomerular filtration rate ≥ 30 ml/min/1.73m2 and proteinuria ≥1.0 g/24h were randomly assigned to receive leflunomide+low-dose corticosteroid (leflunomide group; n = 40) or full-dose corticosteroid (corticosteroids group; n = 45). The primary outcome was renal survival; secondary outcomes were proteinuria and adverse events. After 12 months of treatment and an average follow-up of 88 months, 11.1% vs. 7.5% of patients reached end-stage renal disease and 20% versus 10% of patients had a ≥ 50% increase in serum creatinine in the corticosteroids and leflunomide groups, respectively. Kaplan-Meier analysis did not reveal a between-group difference in these outcomes. Decreases in 24-hour proteinuria were similar in the two groups during the treatment period, but a more marked reduction was observed during follow-up in the leflunomide group. Although the incidence of adverse events was similar in the two groups, serious adverse events were observed only in the corticosteroid group. Thus, leflunomide combined with low-dose corticosteroid is at least as effective as corticosteroid alone for the treatment of progressive IgA nephropathy, and showed a greater reduction of proteinuria during long-term follow-up and fewer severe adverse events.

Risks and Benefits Associated With Antibiotic Use for Acute Respiratory Infections: A Cohort Study

PubMed Central

Meropol, Sharon B.; Localio, A. Russell; Metlay, Joshua P.

2013-01-01

PURPOSE Antibiotics are frequently prescribed for acute nonspecific respiratory infections (ARIs), presumably to avoid small risks of progression to serious bacterial illness. However, even low risks of associated adverse drug events could result in many such events at the population level. Our objective was to assess the risks and benefits of antibiotic use in a cohort of patients with ARIs, comparing outcomes of patients who were prescribed antibiotics with outcomes of patients not receiving antibiotics. METHODS We used a June 1986 to August 2006 cohort of adult patients with ARI visits from a UK primary care database. Exposure was an antibiotic prescribed with the visit. Primary outcomes were hospitalization within 15 days for (1) severe adverse drug events (hypersensitivity, diarrhea, seizure, arrhythmia, hepatic or renal failure), and (2) community-acquired pneumonia. RESULTS The cohort included 1,531,019 visits with an ARI diagnosis; prescriptions for antibiotics were given in 65% of cases. The adjusted risk difference for treated vs untreated patients per 100,000 visits was 1.07 fewer adverse events (95% CI, −4.52 to 2.38; P = .54) and 8.16 fewer pneumonia hospitalizations (95% CI, −13.24 to −3.08; P = .002). The number needed to treat to prevent 1 hospitalization for pneumonia was 12,255. CONCLUSIONS Compared with patients with ARI who were not treated with antibiotics, patients who were treated with antibiotics were not at increased risk of severe adverse drug events and had a small decreased risk of pneumonia hospitalization. This small benefit from antibiotics for a common ambulatory diagnosis creates persistent tension; at the societal level, physicians are compelled to reduce antibiotic prescribing, thus minimizing future resistance, whereas at the encounter level, they are compelled to optimize the benefit-risk balance for that patient. PMID:23508604

Risks and benefits associated with antibiotic use for acute respiratory infections: a cohort study.

PubMed

Meropol, Sharon B; Localio, A Russell; Metlay, Joshua P

2013-01-01

Antibiotics are frequently prescribed for acute nonspecific respiratory infections (ARIs), presumably to avoid small risks of progression to serious bacterial illness. However, even low risks of associated adverse drug events could result in many such events at the population level. Our objective was to assess the risks and benefits of antibiotic use in a cohort of patients with ARIs, comparing outcomes of patients who were prescribed antibiotics with outcomes of patients not receiving antibiotics. We used a June 1986 to August 2006 cohort of adult patients with ARI visits from a UK primary care database. Exposure was an antibiotic prescribed with the visit. Primary outcomes were hospitalization within 15 days for (1) severe adverse drug events (hypersensitivity, diarrhea, seizure, arrhythmia, hepatic or renal failure), and (2) community-acquired pneumonia. The cohort included 1,531,019 visits with an ARI diagnosis; prescriptions for antibiotics were given in 65% of cases. The adjusted risk difference for treated vs untreated patients per 100,000 visits was 1.07 fewer adverse events (95% CI, -4.52 to 2.38; P = .54) and 8.16 fewer pneumonia hospitalizations (95% CI, -13.24 to -3.08; P = .002). The number needed to treat to prevent 1 hospitalization for pneumonia was 12,255. Compared with patients with ARI who were not treated with antibiotics, patients who were treated with antibiotics were not at increased risk of severe adverse drug events and had a small decreased risk of pneumonia hospitalization. This small benefit from antibiotics for a common ambulatory diagnosis creates persistent tension; at the societal level, physicians are compelled to reduce antibiotic prescribing, thus minimizing future resistance, whereas at the encounter level, they are compelled to optimize the benefit-risk balance for that patient.

Syncope paradox in the outcome of patients with pulmonary thromboembolism: short-term and midterm outcome.

PubMed

Seyyedi, Seyyed-reza; Jenab, Yaser; Tokaldany, Masoumeh Lotfi; Shirani, Shapoor; Sadeghian, Saeed; Jalali, Arash

2016-01-01

We compare the early and midterm outcomes of pulmonary thromboembolism (PTE) in patients with and without syncope in our single-center registry. Between December 2006 and May 2013, 351 consecutive patients (mean age = 60.21 ± 16.91 years, 55.3% male) with confirmed acute symptomatic PTE were divided in with and without syncope groups. Groups were compared in terms of the effect of syncope on 30-day mortality and adverse events, and mortality in a median follow-up time of 16.9 months. From 351 patients, 39 (11.1%) had syncope and 312 (88.9%) did not. Syncope group had less frequently chest pain (30.8% vs 51.4%; P value = 0.015). Also, the rates of 30-day adverse events and mortality were 12.8% and 5.1% for the group with syncope, and 14.4% and 10.3% for the group without syncope, respectively, with no significant difference. At follow up, 65 patients died and mortality was 18.5% for 351 patients (5.1% in the group with syncope and 20.2% for the other group). After adjustment for confounding factors, the effect of syncope on 30-day adverse events and mortality remained non-significant and on the midterm mortality was significant, showing that the presence of syncope was associated with lower midterm mortality (P value = 0.038). Among PTE patients in our registry, 11.1% presented with syncope. Relationship between syncope and 30-day adverse events and mortality remained non-significant after adjustments for other factors. However, in midterm follow up, patients with syncope were significantly at decreased risk of mortality compared to those without syncope. © 2014 John Wiley & Sons Ltd.

Pregnancy-Associated Plasma Protein A Levels in Late First Trimester Pregnancies with Small-for-Gestational Age Neonates: A Prospective Case-Control Study.

PubMed

Agarwal, Rachna; Kumari, Radhika; Mehndiratta, Mohit; Radhakrishnan, Gita; Faridi, M M A; Chandra, Nilesh

2017-08-01

We aimed to investigate the association of pregnancy associated plasma protein A (PAPP-A) levels in late first trimester with small for gestational age (SGA) neonates and adverse pregnancy outcomes in a low-income setting. The inclusion criteria were late first trimester (11-13 + 6 weeks) women with singleton and non-anomalous pregnancy. Enrolled participants were sampled for PAPP-A and prospectively followed up for delivery outcome and antenatal complications. A multiple of median (MoM) was calculated and statistically compared between groups. Out of total 284 subjects, 14.54% delivered SGA babies and formed cases (Group A), 66.5% delivered appropriate for gestational age (AGA) neonates with uneventful antenatal period (controls, Group B), and 19.3% were AGA group with adverse pregnancy complications (Group C). The late first trimester median PAPP-A MoM was significantly lower (0.61) in Group A compared to Group B (1.47). Using receiver operating characteristic (ROC) curve for PAPP-A MoM, optimal cutoff value was found at 0.45 MoM, with positive predictive value of 56.2%, specificity of 92.6% and sensitivity of 45%. The median interquartile range (IQR) of PAPP-A MoM value in Group C in comparison with Group B was significantly lower except for abruption. At PAPP-A MoM cutoff value <1, <0.8, <0.6 and <0.4, the odds ratio for adverse pregnancy outcome was 8.30, 7.29, 10.97 and 10.60, respectively, indicating an inverse relationship. With 0.45 MoM cutoff of PAPP-A, the detection rate, specificity and positive predictive value for SGA were 45, 92.6 and 56.2%, respectively. As PAPP-A MoM values decreased, the odds ratio of having adverse pregnancy outcomes increased.

Is it appropriate for Korean women to adopt the 2009 Institute of Medicine recommendations for gestational weight gain?

PubMed

Wie, Jeong Ha; Park, In Yang; Namkung, Jeong; Seo, Hae Won; Jeong, Min Jin; Kwon, Ji Young

2017-01-01

The 2009 Institute of Medicine (IOM) guidelines for gestational weight gain (GWG) are intended for use among women in the United States. Little data are available on whether the 2009 IOM recommendations can be applied to Asian women. This study aimed to evaluate whether the recommendations are related to adverse pregnancy outcomes in Korean pregnant women. A retrospective cohort study was conducted for all singleton-pregnant women at a university hospital in Korea. After classifying the enrolled women into four Korean pre-pregnancy body mass index (BMI) categories, the risk of adverse pregnancy outcomes were analyzed for women who gained inadequate or excessive GWG based on 2009 IOM recommendations. Of 7,843 pregnancies, 64.0% of women had normal pre-pregnancy BMI and 42.7% achieved optimal GWG. Across all BMI categories, adverse pregnancies outcomes such as small for gestational age (SGA), large for gestational age (LGA), preterm birth, preeclampsia, and cesarean due to dystocia were significantly associated with GWG (all P ≤ 0.001).Women with normal BMI who gained inadequate weight were more likely to develop SGA and preterm birth and less likely to develop LGA (adjusted odds ratio (aOR) 2.21, 1.33, and 0.54, respectively). Whereas, women with normal BMI who gained excessive weight were more likely to develop LGA, preterm birth, preeclampsia, and cesarean section due to dystocia (aOR 2.10, 1.33, 1.37, and 1.37, respectively) and less likely to develop SGA (aOR 0.60). It is tolerable for Korean women to follow recommended GWG from the 2009 IOM guidelines to decrease adverse pregnancy outcomes. This will be helpful for antenatal care on GWG not only for Korean pregnant women, but also other Asian women who have lower BMI criteria than Caucasian women.

Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials

PubMed Central

Kahn, S. E.; Jones, N. P.; Noronha, D.; Beck-Nielsen, H.; Viberti, G.

2010-01-01

Aims/hypothesis Observational and mechanistic studies have suggested a possible relationship between treatment with metformin and decreased incidence of cancer in participants with type 2 diabetes. We extracted data for malignancies from the ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) randomised controlled clinical trials, in which the efficacy and/or safety of metformin was assessed in comparison with sulfonylureas and rosiglitazone. Methods Neoplasm occurrences were collected as adverse events in these studies. We reviewed and re-analysed the individual participant data in both studies for serious adverse events, malignancies reported as adverse events and related neoplasms of special interest. Results In ADOPT, 50 participants (3.4%) on metformin and 55 (3.8%) on each of rosiglitazone and glibenclamide (known as glyburide in the USA and Canada) developed serious adverse event malignancies (excluding non-melanoma skin cancers). This corresponds to 1.03, 1.12 and 1.31 per 100 person-years, giving hazard ratios for metformin of 0.92 (95% CI 0.63–1.35) vs rosiglitazone and 0.78 (0.53–1.14) vs glibenclamide. In RECORD, on a background of sulfonylurea, 69 (6.1%) participants developed malignant neoplasms in the metformin group, compared with 56 (5.1%) in the rosiglitazone group (HR 1.22 [0.86–1.74]). On a background of metformin, 74 (6.7%) participants in the sulfonylurea group developed malignant neoplasms, compared with 57 (5.1%) in the rosiglitazone group (HR 1.33 [0.94–1.88]). Conclusions/interpretation The malignancy rates in these two randomised controlled clinical trials do not support a view that metformin offers any particular protection against malignancy compared with rosiglitazone. However, they do not refute the possibility of a difference compared with sulfonylureas. PMID:20532476

Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials.

PubMed

Home, P D; Kahn, S E; Jones, N P; Noronha, D; Beck-Nielsen, H; Viberti, G

2010-09-01

Observational and mechanistic studies have suggested a possible relationship between treatment with metformin and decreased incidence of cancer in participants with type 2 diabetes. We extracted data for malignancies from the ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) randomised controlled clinical trials, in which the efficacy and/or safety of metformin was assessed in comparison with sulfonylureas and rosiglitazone. Neoplasm occurrences were collected as adverse events in these studies. We reviewed and re-analysed the individual participant data in both studies for serious adverse events, malignancies reported as adverse events and related neoplasms of special interest. In ADOPT, 50 participants (3.4%) on metformin and 55 (3.8%) on each of rosiglitazone and glibenclamide (known as glyburide in the USA and Canada) developed serious adverse event malignancies (excluding non-melanoma skin cancers). This corresponds to 1.03, 1.12 and 1.31 per 100 person-years, giving hazard ratios for metformin of 0.92 (95% CI 0.63-1.35) vs rosiglitazone and 0.78 (0.53-1.14) vs glibenclamide. In RECORD, on a background of sulfonylurea, 69 (6.1%) participants developed malignant neoplasms in the metformin group, compared with 56 (5.1%) in the rosiglitazone group (HR 1.22 [0.86-1.74]). On a background of metformin, 74 (6.7%) participants in the sulfonylurea group developed malignant neoplasms, compared with 57 (5.1%) in the rosiglitazone group (HR 1.33 [0.94-1.88]). The malignancy rates in these two randomised controlled clinical trials do not support a view that metformin offers any particular protection against malignancy compared with rosiglitazone. However, they do not refute the possibility of a difference compared with sulfonylureas.

Is it appropriate for Korean women to adopt the 2009 Institute of Medicine recommendations for gestational weight gain?

PubMed Central

Namkung, Jeong; Seo, Hae Won; Jeong, Min Jin

2017-01-01

Background The 2009 Institute of Medicine (IOM) guidelines for gestational weight gain (GWG) are intended for use among women in the United States. Little data are available on whether the 2009 IOM recommendations can be applied to Asian women. This study aimed to evaluate whether the recommendations are related to adverse pregnancy outcomes in Korean pregnant women. Methods and findings A retrospective cohort study was conducted for all singleton-pregnant women at a university hospital in Korea. After classifying the enrolled women into four Korean pre-pregnancy body mass index (BMI) categories, the risk of adverse pregnancy outcomes were analyzed for women who gained inadequate or excessive GWG based on 2009 IOM recommendations. Of 7,843 pregnancies, 64.0% of women had normal pre-pregnancy BMI and 42.7% achieved optimal GWG. Across all BMI categories, adverse pregnancies outcomes such as small for gestational age (SGA), large for gestational age (LGA), preterm birth, preeclampsia, and cesarean due to dystocia were significantly associated with GWG (all P ≤ 0.001).Women with normal BMI who gained inadequate weight were more likely to develop SGA and preterm birth and less likely to develop LGA (adjusted odds ratio (aOR) 2.21, 1.33, and 0.54, respectively). Whereas, women with normal BMI who gained excessive weight were more likely to develop LGA, preterm birth, preeclampsia, and cesarean section due to dystocia (aOR 2.10, 1.33, 1.37, and 1.37, respectively) and less likely to develop SGA (aOR 0.60). Conclusions It is tolerable for Korean women to follow recommended GWG from the 2009 IOM guidelines to decrease adverse pregnancy outcomes. This will be helpful for antenatal care on GWG not only for Korean pregnant women, but also other Asian women who have lower BMI criteria than Caucasian women. PMID:28704550

Direct effects of leptin and adiponectin on peripheral reproductive tissues: a critical review

PubMed Central

Kawwass, Jennifer F.; Summer, Ross; Kallen, Caleb B.

2015-01-01

Obesity is a risk factor for infertility and adverse reproductive outcomes. Adipose tissue is an important endocrine gland that secretes a host of endocrine factors, called adipokines, which modulate diverse physiologic processes including appetite, metabolism, cardiovascular function, immunity and reproduction. Altered adipokine expression in obese individuals has been implicated in the pathogenesis of a host of health disorders including diabetes and cardiovascular disease. It remains unclear whether adipokines play a significant role in the pathogenesis of adverse reproductive outcomes in obese individuals and, if so, whether the adipokines are acting directly or indirectly on the peripheral reproductive tissues. Many groups have demonstrated that receptors for the adipokines leptin and adiponectin are expressed in peripheral reproductive tissues and that these adipokines are likely, therefore, to exert direct effects on these tissues. Many groups have tested for direct effects of leptin and adiponectin on reproductive tissues including the testis, ovary, uterus, placenta and egg/embryo. The hypothesis that decreased fertility potential or adverse reproductive outcomes may result, at least in part, from defects in adipokine signaling within reproductive tissues has also been tested. Here, we present a critical analysis of published studies with respect to two adipokines, leptin and adiponectin, for which significant data have been generated. Our evaluation reveals significant inconsistencies and methodological limitations regarding the direct effects of these adipokines on peripheral reproductive tissues. We also observe a pervasive failure to account for in vivo data that challenge observations made in vitro. Overall, while leptin and adiponectin may directly modulate peripheral reproductive tissues, existing data suggest that these effects are minor and non-essential to human or mouse reproductive function. Current evidence suggests that direct effects of leptin or adiponectin on peripheral reproductive tissues are unlikely to factor significantly in the adverse reproductive outcomes observed in obese individuals. PMID:25964237

Maternal psychological distress during pregnancy does not increase the risk for adverse birth outcomes.

PubMed

Staneva, Aleksandra A; Morawska, Alina; Bogossian, Fiona; Wittkowski, Anja

2018-01-01

Maternal psychological distress during pregnancy is a potential risk factor for various birth complications. This study aimed to explore psychological factors associated with adverse birth outcomes. Symptoms of psychological distress, individual characteristics, and medical complications were assessed at two time points antenatally in 285 women from Australia and New Zealand; birth outcomes were assessed postpartum, between January 2014 and September 2015. Hierarchical multiple regression analyses were conducted to examine the relation of psychological distress to adverse birth outcomes. Medical complications during pregnancy, such as serious infections, placental problems and preeclampsia, and antenatal cannabis use, were the factors most strongly associated with adverse birth outcomes, accounting for 22 percent of the total variance (p < .001). Symptoms of depression and/or anxiety, low social support, and low sense of coherence were not associated with birth complications. In unadjusted analyses, self-reported diagnosis of anxiety disorder during pregnancy and an orientation toward a Regulator mothering style were associated with adverse birth outcomes; however, after controlling for medical complications, these were no longer associated. Our study results indicate that antenatal depressive and/or anxiety symptoms were not independently associated with adverse birth outcomes, a reassuring finding for women who are already psychologically vulnerable during pregnancy.

Collaborative activities and treatment outcomes in patients with HIV-associated tuberculosis in Viet Nam.

PubMed

Huyen, T T T; Nhung, N V; Shewade, H D; Hoa, N B; Harries, A D

2016-03-21

The National Tuberculosis (TB) Programme in Viet Nam and Ho Chi Minh City (HCMC). To determine 1) at national level between 2011 and 2013, the relationship between human immunodeficiency virus (HIV) testing, uptake of TB-HIV interventions and adverse treatment outcomes among TB-HIV patients; and 2) in HCMC in 2013, patient characteristics associated with adverse outcomes. An ecological study reviewing aggregate nationwide data and a retrospective cohort review in HCMC. Nationwide, from 2011 to 2013, HIV testing increased in TB patients from 58% to 68% and antiretroviral therapy (ART) increased in TB-HIV patients from 54% to 63%. Adverse treatment outcomes in TB-HIV patients increased from 24% to 27%, largely due to transfer out (5-9% increase) and death. The Northern and Highland regions showed poor uptake of TB-HIV interventions. In HCMC, 303 (27%) of 1110 TB-HIV patients had adverse outcomes, with higher risks observed in those with previously treated TB, those diagnosed as HIV-positive before TB onset and those never placed on cotrimoxazole or ART. Despite improving HIV testing rates and TB-HIV interventions, adverse outcomes in TB-HIV patients remain at about 26%. Characteristics predicting higher risk of adverse outcomes must be addressed if Viet Nam wishes to end the TB epidemic by 2030.

Reproductive Outcomes Associated with Noise Exposure — A Systematic Review of the Literature

PubMed Central

Ristovska, Gordana; Laszlo, Helga Elvira; Hansell, Anna L.

2014-01-01

Introduction: High noise exposure during critical periods in gestation is a potential stressor that may result in increased risk of implantation failure, dysregulation of placentation or decrease of uterine blood flow. This paper systematically reviews published evidence on associations between reproductive outcomes and occupational and environmental noise exposure. Methods: The Web of Science, PubMed and Embase electronic databases were searched for papers published between 1970 to June 2014 and via colleagues. We included 14 epidemiological studies related to occupational noise exposure and nine epidemiological studies related to environmental noise exposure. There was some evidence for associations between occupational noise exposure and low birthweight, preterm birth and small for gestational age, either independently or together with other occupational risk factors. Five of six epidemiologic studies, including the two largest studies, found significant associations between lower birthweight and higher noise exposure. There were few studies on other outcomes and study design issues may have led to bias in assessments in some studies. Conclusions: There is evidence for associations between noise exposure and adverse reproductive outcomes from animal studies. Few studies in have been conducted in humans but there is some suggestive evidence of adverse associations with environmental noise from both occupational and epidemiological studies, especially for low birthweight. PMID:25101773

Validation and Potential Mechanisms of Red Cell Distribution Width as a Prognostic Marker in Heart Failure

PubMed Central

ALLEN, LARRY A.; FELKER, G. MICHAEL; MEHRA, MANDEEP R.; CHIONG, JUN R.; DUNLAP, STEPHANIE H.; GHALI, JALAL K.; LENIHAN, DANIEL J.; OREN, RON M.; WAGONER, LYNNE E.; SCHWARTZ, TODD A.; ADAMS, KIRKWOOD F.

2014-01-01

Background: Adverse outcomes have recently been linked to elevated red cell distribution width (RDW) in heart failure. Our study sought to validate the prognostic value of RDW in heart failure and to explore the potential mechanisms underlying this association. Methods and Results: Data from the Study of Anemia in a Heart Failure Population (STAMINA-HFP) registry, a prospective, multicenter cohort of ambulatory patients with heart failure supported multivariable modeling to assess relationships between RDW and outcomes. The association between RDW and iron metabolism, inflammation, and neurohormonal activation was studied in a separate cohort of heart failure patients from the United Investigators to Evaluate Heart Failure (UNITE-HF) Biomarker registry. RDW was independently predictive of outcome (for each 1% increase in RDW, hazard ratio for mortality 1.06, 95% CI 1.01-1.12; hazard ratio for hospitalization or mortality 1.06; 95% CI 1.02-1.10) after adjustment for other covariates. Increasing RDW correlated with decreasing hemoglobin, increasing interleukin-6, and impaired iron mobilization. Conclusions: Our results confirm previous observations that RDW is a strong, independent predictor of adverse outcome in chronic heart failure and suggest elevated RDW may indicate inflammatory stress and impaired iron mobilization. These findings encourage further research into the relationship between heart failure and the hematologic system. PMID:20206898

Validation and potential mechanisms of red cell distribution width as a prognostic marker in heart failure.

PubMed

Allen, Larry A; Felker, G Michael; Mehra, Mandeep R; Chiong, Jun R; Dunlap, Stephanie H; Ghali, Jalal K; Lenihan, Daniel J; Oren, Ron M; Wagoner, Lynne E; Schwartz, Todd A; Adams, Kirkwood F

2010-03-01

Adverse outcomes have recently been linked to elevated red cell distribution width (RDW) in heart failure. Our study sought to validate the prognostic value of RDW in heart failure and to explore the potential mechanisms underlying this association. Data from the Study of Anemia in a Heart Failure Population (STAMINA-HFP) registry, a prospective, multicenter cohort of ambulatory patients with heart failure supported multivariable modeling to assess relationships between RDW and outcomes. The association between RDW and iron metabolism, inflammation, and neurohormonal activation was studied in a separate cohort of heart failure patients from the United Investigators to Evaluate Heart Failure (UNITE-HF) Biomarker registry. RDW was independently predictive of outcome (for each 1% increase in RDW, hazard ratio for mortality 1.06, 95% CI 1.01-1.12; hazard ratio for hospitalization or mortality 1.06; 95% CI 1.02-1.10) after adjustment for other covariates. Increasing RDW correlated with decreasing hemoglobin, increasing interleukin-6, and impaired iron mobilization. Our results confirm previous observations that RDW is a strong, independent predictor of adverse outcome in chronic heart failure and suggest elevated RDW may indicate inflammatory stress and impaired iron mobilization. These findings encourage further research into the relationship between heart failure and the hematologic system. Copyright (c) 2010 Elsevier Inc. All rights reserved.

A case study to illustrate the utility of the Aggregate Exposure Pathway and Adverse Outcome Pathway frameworks for integrating human health and ecological data into cumulative risk assessment

EPA Science Inventory

Cumulative risk assessment (CRA) methods, which evaluate the risk of multiple adverse outcomes (AOs) from multiple chemicals, promote the use of a conceptual site model (CSM) to integrate risk from relevant stressors. The Adverse Outcome Pathway (AOP) framework can inform these r...

Interventions designed to prevent adverse programming outcomes resulting from exposure to maternal obesity during development

PubMed Central

Nathanielsz, PW; Ford, SP; Long, NM; Vega, CC; Reyes-Castro, LA; Zambrano, E

2013-01-01

Maternal obesity is a global epidemic affecting the developed and developing world. Human and animal studies indicate that maternal obesity programs development predisposing offspring to later-life chronic diseases. Several mechanisms act together to produce these adverse health problems. There is a need for effective interventions that prevent these outcomes and guide management in human pregnancy. We report here dietary and exercise intervention studies in both altricial and precocial species, rats and sheep, designed to prevent adverse offspring outcomes. Both interventions present exciting opportunities to at least in part prevent adverse metabolic and other outcomes in mother and offspring. PMID:24147928

Outcome of cataract surgery at one year in Kenya, the Philippines and Bangladesh.

PubMed

Lindfield, R; Kuper, H; Polack, S; Eusebio, C; Mathenge, W; Wadud, Z; Rashid, A M; Foster, A

2009-07-01

To assess the change in vision following cataract surgery in Kenya, Bangladesh and the Philippines and to identify causes and predictors of poor outcome. Cases were identified through surveys, outreach and clinics. They underwent preoperative visual acuity measurement and ophthalmic examination. Cases were re-examined 8-15 months after cataract surgery. Information on age, gender, poverty and literacy was collected at baseline. 452 eyes of 346 people underwent surgery. 124 (27%) eyes had an adverse outcome. In Kenya and the Philippines, the main cause of adverse outcome was refractive error (37% and 49% respectively of all adverse outcomes) then comorbid ocular disease (26% and 27%). In Bangladesh, this was comorbid disease (58%) then surgical complications (21%). There was no significant association between adverse outcome and gender, age, literacy, poverty or preoperative visual acuity. Adverse outcomes following cataract surgery were frequent in the three countries. Main causes were refractive error and preoperative comorbidities. Many patients are not attaining the outcomes available with modern surgery. Focus should be on correcting refractive error, through operative techniques or postoperative refraction, and on a system for assessing comorbidities and communicating risk to patients. These are only achievable with a commitment to ongoing surgical audit.

Computational Approaches for Identifying Adverse Outcome Pathways

EPA Science Inventory

Adverse Outcome Pathways (AOPs) provide a framework for organizing toxicity information to improve predictions of the potential adverse impact of environment stressors on humans or wildlife populations, but these benefits are currently limited by the small number of AOPs currentl...

A post-weaning fish oil dietary intervention reverses adverse metabolic outcomes and 11β-hydroxysteroid dehydrogenase type 1 expression in postnatal overfed rats.

PubMed

Dai, Yanyan; Yang, Fan; Zhou, Nan; Sha, Lijun; Zhou, Shanshan; Wang, Junle; Li, Xiaonan

2016-11-01

Early life is considered a critical period for determining long-term metabolic health. Postnatal over-nutrition may alter glucocorticoid (GC) metabolism and increase the risk of developing obesity and metabolic disorders in adulthood. Our aim was to assess the effects of the dose and timing of a fish oil diet on obesity and the expression of GC-activated enzyme 11β-hydroxysteroid dehydrogenase type 1 (HSD1) in postnatal overfed rats. Litter sizes were adjusted to three (small litter (SL)) or ten (normal litter) rats on postnatal day 3 to induce overfeeding or normal feeding. The SL rats were divided into three groups after weaning: high-dose fish oil (HFO), low-dose fish oil (LFO) and standard-diet groups. After 10 weeks, the HFO diet reduced body weight gain (16 %, P0·05). In conclusion, the post-weaning HFO diet could reverse adverse outcomes and decrease tissue GC activity in postnatal overfed rats.

Decreasing adverse outcomes of unmodified electroconvulsive therapy: suggestions and possibilities.

PubMed

Gallegos, Jesus; Vaidya, Punit; D'Agati, Douglas; Jayaram, Geetha; Nguyen, Thai; Tripathi, Adarsh; Trivedi, Jitendra K; Reti, Irving M

2012-06-01

Electroconvulsive therapy (ECT) is far and away the most effective treatment for depression and quite effective for a range of other psychiatric conditions that are unresponsive to medication. Electroconvulsive therapy in the developed world has been administered with anesthesia, muscle relaxants, and ventilation since the mid-1950s following 20 years of unmodified treatment. However, in much of the developing world, ECT continues to be administered unmodified because of lack of resources. We review the efficacy of unmodified compared with modified treatment. We also review the potential drawbacks of unmodified treatment including fear and anxiety, worse postictal confusion, fracture risk, and the negative effects of unmodified treatment on how ECT is perceived in the general community. Finally, we consider potential solutions in developing countries to minimize adverse outcomes of unmodified treatment by pretreating patients either with low-dose benzodiazepines or sedating, but not anesthetizing, dosages of anesthetic agents. Randomized controlled trials are necessary before either of these options could be considered an acceptable alternative to completely unmodified treatment when modified treatment is unavailable.

Classification of Individual Well-Being Scores for the Determination of Adverse Health and Productivity Outcomes in Employee Populations

PubMed Central

Sears, Lindsay E.; Coberley, Carter R.; Pope, James E.

2013-01-01

Abstract Adverse health and productivity outcomes have imposed a considerable economic burden on employers. To facilitate optimal worksite intervention designs tailored to differing employee risk levels, the authors established cutoff points for an Individual Well-Being Score (IWBS) based on a global measure of well-being. Cross-sectional associations between IWBS and adverse health and productivity outcomes, including high health care cost, emergency room visits, short-term disability days, absenteeism, presenteeism, low job performance ratings, and low intentions to stay with the employer, were studied in a sample of 11,702 employees from a large employer. Receiver operating characteristics curves were evaluated to detect a single optimal cutoff value of IWBS for predicting 2 or more adverse outcomes. More granular segmentation was achieved by computing relative risks of each adverse outcome from logistic regressions accounting for sociodemographic characteristics. Results showed strong and significant nonlinear associations between IWBS and health and productivity outcomes. An IWBS of 75 was found to be the optimal single cutoff point to discriminate 2 or more adverse outcomes. Logistic regression models found abrupt reductions of relative risk also clustered at IWBS cutoffs of 53, 66, and 88, in addition to 75, which segmented employees into high, high-medium, medium, low-medium, and low risk groups. To determine validity and generalizability, cutoff values were applied in a smaller employee population (N=1853) and confirmed significant differences between risk groups across health and productivity outcomes. The reported segmentation of IWBS into discrete cohorts based on risk of adverse health and productivity outcomes should facilitate well-being comparisons and worksite interventions. (Population Health Management 2013;16:90–98) PMID:23013034

Antenatal care attendance, a surrogate for pregnancy outcome? The case of Kumasi, Ghana

PubMed Central

Ntui, Asundep N.; Jolly, Pauline E.; Carson, April; Turpin, Cornelius A.; Zhang, Kui; Berhanu, Tameru

2016-01-01

Objective Antenatal care (ANC) has been shown to influence infant and maternal outcomes. WHO recommends 4 ANC visits for uncomplicated pregnancies. However, pregnant women in Ghana are required to attend 8–13 antenatal visits. We investigated the association of ANC attendance with adverse pregnancy outcomes (defined as low infant birth weight, stillbirth, preterm delivery or small for gestational age). Method A quantitative cross-sectional study was conducted on 629 women, age 19–48 years who presented for delivery at two selected public hospitals and 16 traditional birth attendants from July-November 2011. Socio-demographic and antenatal information were collected using a structured questionnaire. ANC attendance, medical and obstetric/gynecological history were abstracted from maternal antenatal records. Data were analyzed using chi-square and logistic regression. Results Twenty-two percent of the women experienced an adverse outcome. Eleven percent of the women attended <4 ANC visits. In an unadjusted model, these women had an increased likelihood of experiencing an adverse outcome (OR = 2.27; 95 CI% = 1.30–3.94; p = 0.0038). High parity was also associated with adverse birth outcomes. Women screened for syphilis or use of insecticide-treated bed nets had a 40% and 36% (p = 0.0447 and p = 0.0293) reduced likelihood of experiencing an adverse pregnancy outcome respectively. After adjusting for confounders, attending <4 antenatal visits was associated with adverse pregnancy outcome compared with ≥4 ANC visits (Adjusted OR = 2.55; 95% CI = 1.16– 5.63; p = 0.0202). Conclusion Attending <4 antenatal visits and high parity were associated with adverse pregnancy outcomes for uncomplicated pregnancies. PMID:23948806

1991 Gulf War exposures and adverse birth outcomes.

PubMed

Arnetz, Bengt; Drutchas, Alexis; Sokol, Robert; Kruger, Michael; Jamil, Hikmet

2013-01-01

We studied 1991 Gulf War (GW)-related environmental exposures and adverse birth outcomes in Iraqis. A random cross-sectional sample of 307 Iraqi families that immigrated to the United States responded to a structured interview covering socioeconomics, lifestyle, environmental exposures, and birth outcome. Data per each family was collected either from the man or the woman in the respective family. The respondents were divided into those that resided in Iraq during and following the GW (post-GW, n=185) and those that had left before (pre-GW, n=122). The primary outcome was lifetime prevalence of adverse birth outcomes, ie, congenital anomalies, stillbirth, low birth weight, and preterm delivery and its relationship to GW exposures. Mean number of adverse birth outcomes increased from 3.43 (SD=2.11) in the pre-GW to 4.63 (SD=2.63) in the post-GW group (P<.001). Mean chemical (Ch) and nonchemical (NCh) environmental exposure scores increased from pre-GW scores of 0.38 units (SD=1.76) and 0.43 (SD=1.86), respectively, to post-GW scores of 5.65 units (SD=6.23) and 7.26 (SD=5.67), P<.001 between groups for both exposures. There was a significant dose-response relationship between Ch environmental exposure (P=.001), but not NCh exposure, and number of adverse birth outcomes. Exposure to burning oil pits and mustard gas increased the risks for specific adverse birth outcomes by 2 to 4 times. Results indicate that Gulf War Ch, but not NCh exposures are related to adverse birth outcomes. Pregnancies in women with a history of war exposures might benefit from more intensive observation.

Effects of Levothyroxine Therapy on Pregnancy Outcomes in Women with Subclinical Hypothyroidism.

PubMed

Maraka, Spyridoula; Singh Ospina, Naykky M; O'Keeffe, Derek T; Rodriguez-Gutierrez, Rene; Espinosa De Ycaza, Ana E; Wi, Chung-Il; Juhn, Young J; Coddington, Charles C; Montori, Victor M; Stan, Marius N

2016-07-01

Subclinical hypothyroidism (SCH) has been associated with increased risk of adverse pregnancy outcomes in some, but not all, studies. Uncertainty remains regarding the impact of levothyroxine (LT4) therapy on improving health outcomes in pregnant women with SCH. The objective of this study was to assess the potential benefits of LT4 therapy in pregnant women with SCH. The medical records were reviewed of pregnant women with SCH, defined as an elevated serum thyrotropin (TSH) of >2.5 mIU/L for the 1st trimester or >3 mIU/L for the 2nd and 3rd trimesters, but ≤10 mIU/L. Pregnant women were divided into two groups depending on whether they received LT4 (group A) or not (group B). Pregnancy loss and other pre-specified adverse outcomes were evaluated during follow-up. There were 82 women in group A and 284 in group B. Group A had a higher body mass index (p = 0.04) and a higher serum TSH level (p < 0.0001) compared with group B. Group A had fewer pregnancies lost (n = 5 [6.1%] vs. n = 25 [8.8%]; p = 0.12), low birth weight (LBW) offspring (1.3% vs. 10%; p < 0.001), and no neonates with a five-minute Apgar score ≤7 (0% vs. 7%; p < 0.001) compared with group B. Other pregnancy-related adverse outcomes were similar between the two groups. Inferences remained unchanged after considering different models to adjust for potential predictors of outcome. LT4 therapy is associated with a decreased risk of LBW and a low Apgar score among women with SCH. This association awaits confirmation in randomized trials before the widespread use of LT4 therapy in pregnant women with SCH.

Excluding infection through procalcitonin testing improves outcomes of congestive heart failure patients presenting with acute respiratory symptoms: results from the randomized ProHOSP trial.

PubMed

Schuetz, Philipp; Kutz, Alexander; Grolimund, Eva; Haubitz, Sebastian; Demann, Désirée; Vögeli, Alaadin; Hitz, Fabienne; Christ-Crain, Mirjam; Thomann, Robert; Falconnier, Claudine; Hoess, Claus; Henzen, Christoph; Marlowe, Robert J; Zimmerli, Werner; Mueller, Beat

2014-08-20

We sought to determine whether exclusion of infection and antibiotic stewardship with the infection biomarker procalcitonin improves outcomes in congestive heart failure (CHF) patients presenting to emergency departments with respiratory symptoms and suspicion of respiratory infection. We performed a secondary analysis of patients with a past medical history of CHF formerly included in a Swiss multicenter randomized-controlled trial. The trial compared antibiotic stewardship according to a procalcitonin algorithm or state-of-the-art guidelines (controls). The primary endpoint was a 30-day adverse outcome (death, intensive care unit admission); the secondary endpoints included a 30-day antibiotic exposure. In the 110/233 analyzed patients (47.2%) with low initial procalcitonin (<0.25 μg/L), suggesting the absence of systemic bacterial infection, those randomized to procalcitonin guidance (n=50) had a significantly lower adverse outcome rate compared to controls (n=60): 4% vs. 20% (absolute difference -16.0%, 95% confidence interval (CI) -28.4% to -3.6%, P=0.01), and significantly reduced antibiotic exposure [days] (mean 3.7 ± 4.0 vs. 6.5 ± 4.4, difference -2.8 [95% CI, -4.4 to -1.2], P<0.01). When initial procalcitonin was ≥0.25 μg/L, procalcitonin-guided patients had significantly reduced antibiotic exposure due to early stop of therapy without any difference in adverse outcomes (25.8% vs. 24.6%, difference [95% CI] 1.2% [-14.5% to 16.9%, P=0.88]). CHF patients presenting to the emergency department with respiratory symptoms and suspicion for respiratory infection had decreased antibiotic exposure and improved outcomes when procalcitonin measurement was used to exclude bacterial infection and guide antibiotic treatment. These data provide further evidence for the potential harmful effects of antibiotic / fluid treatment when used instead of diuretics and heart failure medication in clinically symptomatic CHF patients without underlying infection. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Cardiovascular recovery from psychological and physiological challenge and risk for adverse cardiovascular outcomes and all-cause mortality

PubMed Central

Panaite, Vanessa; Salomon, Kristen; Jin, Alvin; Rottenberg, Jonathan

2015-01-01

Objective Exaggerated cardiovascular (CV) reactivity to laboratory challenge has been shown to predict future CV morbidity and mortality. CV recovery, has been less studied, and has yielded inconsistent findings, possibly due to presence of moderators. Reviews on the relationship between CV recovery and CV outcomes have been limited to cross-sectional studies and have not considered methodological factors. We performed a comprehensive meta-analytic review of the prospective literature investigating CV recovery to physical and psychological challenge and adverse cardiovascular outcomes. Methods We searched PsycINFO and PubMed for prospective studies investigating the relationship between CV recovery and adverse CV outcomes. Studies were coded for variables of interest and for effect sizes (ES). We conducted a random effects weighted meta-analysis. Moderators were examined with ANOVA-analog and meta-regression analyses. Results Thirty seven studies met inclusion criteria (N=125386). Impaired recovery from challenge predicted adverse cardiovascular outcomes (summary effect, r = .17, p < .001). Physical challenge was associated with larger predictive effects than psychological challenge. Moderator analyses revealed that recovery measured at 1 minute post-exercise, passive recovery, use of mortality as an outcome measure, and older sample age were associated with larger effects. Conclusions Poor recovery from laboratory challenges predicts adverse CV outcomes, with recovery from exercise serving as a particularly strong predictor of CV outcomes. The overall ES for recovery and CV outcomes is similar to that observed for CV reactivity and suggests that the study of recovery may have incremental value for understanding adverse CV outcomes. PMID:25829236

Social deprivation and adverse perinatal outcomes among Western and non-Western pregnant women in a Dutch urban population.

PubMed

Poeran, Jashvant; Maas, Arno F G; Birnie, Erwin; Denktas, Semiha; Steegers, Eric A P; Bonsel, Gouke J

2013-04-01

Social deprivation is considered a key factor in adverse perinatal outcomes. Rotterdam, the second largest city in The Netherlands, has large inequalities in perinatal health and a high number of deprived neighbourhoods. Social deprivation is measured here through a composite variable: 'Social Index' (SI). We studied the impact of the SI (2008-2009; 5 categories) in terms of perinatal mortality, congenital anomalies, preterm birth, small for gestational age (SGA) and low 5-minute Apgar score as registered in The Netherlands Perinatal Registry (Rotterdam 2000-2007, n = 56,443 singleton pregnancies). We applied ethnic dichotomisation as Western (European/North-American/Australian) vs. Non-Western (all others) ethnicity was expected to interact with the impact of SI. Tests for trend and multilevel regression analysis were applied. Gradually decreasing prevalence of adverse perinatal outcomes was observed in Western women from the lowest SI category (low social quality) to the highest SI category (high social quality). In Western women the low-high SI gradient for prevalence of spontaneous preterm birth (per 1000) changed from 57.2 to 34.1, for iatrogenic preterm birth from 35.2 to 19.0, for SGA from 119.6 to 59.4, for low Apgar score from 10.9 to 8.2, and for perinatal mortality from 14.9 to 7.6. These trends were statistically confirmed by Chi2-tests for trend (p < 0.001). For non-Western women such trends were absent. These strong effects for Western women were confirmed by significant odds ratios for almost all adverse perinatal outcomes estimated from multilevel regression analysis. We conclude social deprivation to play a different role among Western vs. non-Western women. Our results suggest that improvements in social quality may improve perinatal outcomes in Western women, but alternative approaches may be necessary for non-Western groups. Suggested explanations for non-Western 'migrant' groups include the presence of 'protective' effects through knowledge systems or intrinsic resilience. Implications concern both general and targeted policies. Copyright © 2013 Elsevier Ltd. All rights reserved.

Exercise for patients with major depression: a systematic review with meta-analysis and trial sequential analysis

PubMed Central

Speyer, Helene; Gluud, Christian; Nordentoft, Merete

2017-01-01

Objectives To assess the benefits and harms of exercise in patients with depression. Design Systematic review Data sources Bibliographical databases were searched until 20 June 2017. Eligibility criteria and outcomes Eligible trials were randomised clinical trials assessing the effect of exercise in participants diagnosed with depression. Primary outcomes were depression severity, lack of remission and serious adverse events (eg, suicide) assessed at the end of the intervention. Secondary outcomes were quality of life and adverse events such as injuries, as well as assessment of depression severity and lack of remission during follow-up after the intervention. Results Thirty-five trials enrolling 2498 participants were included. The effect of exercise versus control on depression severity was −0.66 standardised mean difference (SMD) (95% CI −0.86 to −0.46; p<0.001; grading of recommendations assessment, development and evaluation (GRADE): very low quality). Restricting this analysis to the four trials that seemed less affected of bias, the effect vanished into −0.11 SMD (−0.41 to 0.18; p=0.45; GRADE: low quality). Exercise decreased the relative risk of no remission to 0.78 (0.68 to 0.90; p<0.001; GRADE: very low quality). Restricting this analysis to the two trials that seemed less affected of bias, the effect vanished into 0.95 (0.74 to 1.23; p=0.78). Trial sequential analysis excluded random error when all trials were analysed, but not if focusing on trials less affected of bias. Subgroup analyses found that trial size and intervention duration were inversely associated with effect size for both depression severity and lack of remission. There was no significant effect of exercise on secondary outcomes. Conclusions Trials with less risk of bias suggested no antidepressant effects of exercise and there were no significant effects of exercise on quality of life, depression severity or lack of remission during follow-up. Data for serious adverse events and adverse events were scarce not allowing conclusions for these outcomes. Systematic review registration The protocol was published in the journal Systematic Reviews: 2015; 4:40. PMID:28928174

Foundations for screening adverse childhood experiences: Exploring patterns of exposure through infancy and toddlerhood.

PubMed

McKelvey, Lorraine M; Selig, James P; Whiteside-Mansell, Leanne

2017-08-01

Adverse childhood experiences (ACEs) have lifetime consequences for health and development. Identification of ACEs early in childhood provides the potential to intervene before health and development are impaired. This study examined the timing and duration of exposure to ACEs experienced by children from low-income families from ages one to three years to identify whether there were patterns of exposure when infants and toddlers were most vulnerable. We were able to confirm the early negative consequences on cognitive, health, and behavior outcomes previously reported in young children using a national, longitudinal data set of parents and children from low-income households (N=2250). Using Finite Mixture Models, five classes of exposure were identified for children, Consistently Low (63.8%), Decreasing (10.3%), High at Age 2 (11.4%), Increasing (10.4%), and Consistently High (4%). The Consistently Low and Consistently High classes had the most and least optimal development across all domains, respectively. When examining child development outcomes among children with variable exposures to adversities, we found that for cognitive, language, and physical development, the most proximal ACEs were more robust for predicting child outcomes. For socioemotional health, exposure at any time from one to three to ACEs had negative consequences. As a whole, findings from this study highlight the need to consider ACEs screening tools that are both time-sensitive and permit a lifetime report. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cost analysis of nursing home registered nurse staffing times.

PubMed

Dorr, David A; Horn, Susan D; Smout, Randall J

2005-05-01

To examine potential cost savings from decreased adverse resident outcomes versus additional wages of nurses when nursing homes have adequate staffing. A retrospective cost study using differences in adverse outcome rates of pressure ulcers (PUs), urinary tract infections (UTIs), and hospitalizations per resident per day from low staffing and adequate staffing nursing homes. Cost savings from reductions in these events are calculated in dollars and compared with costs of increasing nurse staffing. Eighty-two nursing homes throughout the United States. One thousand three hundred seventy-six frail elderly long-term care residents at risk of PU development. Event rates are from the National Pressure Ulcer Long-Term Care Study. Hospital costs are estimated from Medicare statistics and from charges in the Healthcare Cost and Utilization Project. UTI costs and PU costs are from cost-identification studies. Time horizon is 1 year; perspectives are societal and institutional. Analyses showed an annual net societal benefit of 3,191 dollars per resident per year in a high-risk, long-stay nursing home unit that employs sufficient nurses to achieve 30 to 40 minutes of registered nurse direct care time per resident per day versus nursing homes that have nursing time of less than 10 minutes. Sensitivity analyses revealed a robust set of estimates, with no single or paired elements reaching the cost/benefit equality threshold. Increasing nurse staffing in nursing homes may create significant societal cost savings from reduction in adverse outcomes. Challenges in increasing nurse staffing are discussed.

Transdiagnostic and Transcultural: Pilot Study of Unified Protocol for Depressive and Anxiety Disorders in Japan.

PubMed

Ito, Masaya; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Fujisato, Hiroko; Nakajima, Shun; Kanie, Ayako; Miyamae, Mitsuhiro; Takebayashi, Yoshitake; Horita, Ryo; Usuki, Masato; Nakagawa, Atsuo; Ono, Yutaka

2016-05-01

Unified protocol (UP) is a transdiagnostic cognitive behavior therapy for emotional disorders. It remains unknown whether UP is applicable for use in non-Western countries and for depressive disorders. We therefore examined its feasibility for a Japanese clinical population using this clinical trial design, which is multicentered, open-labeled, and single-armed (Clinical registry: UMIN000008322). The primary outcome was severity of anxiety symptoms, as assessed using Structured Interview Guide for the Hamilton Anxiety Rating Scale. Secondary outcomes were depressive symptoms, clinical global impression, functioning, quality of life, affectivity, emotion regulation, and adverse events. Of the 28 prospective participants, 17 were eligible and enrolled (depressive disorders=9, anxiety disorders=8). Severity of anxiety symptoms, which decreased significantly after the intervention, remained low for 3months (Hedges' g=1.29, 95% CI=0.56-2.06). Similar tendencies were observed for secondary outcome measures. No severe adverse event occurred. Two participants dropped out of the intervention. High treatment adherence and interrater reliability were confirmed. Results suggest the feasibility of UP in the Japanese context sufficient to warrant a larger clinical trial. Copyright © 2016. Published by Elsevier Ltd.

Systematic review of pediatric health outcomes associated with childhood adversity.

PubMed

Oh, Debora Lee; Jerman, Petra; Silvério Marques, Sara; Koita, Kadiatou; Purewal Boparai, Sukhdip Kaur; Burke Harris, Nadine; Bucci, Monica

2018-02-23

Early detection of and intervention in childhood adversity has powerful potential to improve the health and well-being of children. A systematic review was conducted to better understand the pediatric health outcomes associated with childhood adversity. PubMed, PsycArticles, and CINAHL were searched for relevant articles. Longitudinal studies examining various adverse childhood experiences and biological health outcomes occurring prior to age 20 were selected. Mental and behavioral health outcomes were excluded, as were physical health outcomes that were a direct result of adversity (i.e. abusive head trauma). Data were extracted and risk of bias was assessed by 2 independent reviewers. After identifying 15940 records, 35 studies were included in this review. Selected studies indicated that exposure to childhood adversity was associated with delays in cognitive development, asthma, infection, somatic complaints, and sleep disruption. Studies on household dysfunction reported an effect on weight during early childhood, and studies on maltreatment reported an effect on weight during adolescence. Maternal mental health issues were associated with elevated cortisol levels, and maltreatment was associated with blunted cortisol levels in childhood. Furthermore, exposure to childhood adversity was associated with alterations of immune and inflammatory response and stress-related accelerated telomere erosion. Childhood adversity affects brain development and multiple body systems, and the physiologic manifestations can be detectable in childhood. A history of childhood adversity should be considered in the differential diagnosis of developmental delay, asthma, recurrent infections requiring hospitalization, somatic complaints, and sleep disruption. The variability in children's response to adversity suggests complex underlying mechanisms and poses a challenge in the development of uniform diagnostic guidelines. More large longitudinal studies are needed to better understand how adversity, its timing and severity, and the presence of individual genetic, epigenetic, and protective factors affects children's health and development.

Collaborative activities and treatment outcomes in patients with HIV-associated tuberculosis in Viet Nam

PubMed Central

Nhung, N. V.; Shewade, H. D.; Hoa, N. B.; Harries, A. D.

2016-01-01

Setting: The National Tuberculosis (TB) Programme in Viet Nam and Ho Chi Minh City (HCMC). Objectives: To determine 1) at national level between 2011 and 2013, the relationship between human immunodeficiency virus (HIV) testing, uptake of TB-HIV interventions and adverse treatment outcomes among TB-HIV patients; and 2) in HCMC in 2013, patient characteristics associated with adverse outcomes. Design: An ecological study reviewing aggregate nationwide data and a retrospective cohort review in HCMC. Results: Nationwide, from 2011 to 2013, HIV testing increased in TB patients from 58% to 68% and antiretroviral therapy (ART) increased in TB-HIV patients from 54% to 63%. Adverse treatment outcomes in TB-HIV patients increased from 24% to 27%, largely due to transfer out (5–9% increase) and death. The Northern and Highland regions showed poor uptake of TB-HIV interventions. In HCMC, 303 (27%) of 1110 TB-HIV patients had adverse outcomes, with higher risks observed in those with previously treated TB, those diagnosed as HIV-positive before TB onset and those never placed on cotrimoxazole or ART. Conclusion: Despite improving HIV testing rates and TB-HIV interventions, adverse outcomes in TB-HIV patients remain at about 26%. Characteristics predicting higher risk of adverse outcomes must be addressed if Viet Nam wishes to end the TB epidemic by 2030. PMID:27051604

Predicting adverse neonatal outcomes in fetuses with abdominal wall defects using prenatal risk factors.

PubMed

Nicholas, Sara S; Stamilio, David M; Dicke, Jeffery M; Gray, Diana L; Macones, George A; Odibo, Anthony O

2009-10-01

The aim of this study was to determine whether prenatal variables can predict adverse neonatal outcomes in fetuses with abdominal wall defects. A retrospective cohort study that used ultrasound and neonatal records for all cases of gastroschisis and omphalocele seen over a 16-year period. Cases with adverse neonatal outcomes were compared with noncases for multiple candidate predictive factors. Univariable and multivariable statistical methods were used to develop the prediction models, and effectiveness was evaluated using the area under the receiver operating characteristic curve. Of 80 fetuses with gastroschisis, 29 (36%) had the composite adverse outcome, compared with 15 of 33 (47%) live neonates with omphalocele. Intrauterine growth restriction was the only significant variable in gastroschisis, whereas exteriorized liver was the only predictor in omphalocele. The areas under the curve for the prediction models with gastroschisis and omphalocele are 0.67 and 0.74, respectively. Intrauterine growth restriction and exteriorization of the liver are significant predictors of adverse neonatal outcome with gastroschisis and omphalocele.

Worldwide prevalence of adverse pregnancy outcomes associated with in vitro fertilization/intracytoplasmic sperm injection among multiple births: a systematic review and meta-analysis based on cohort studies.

PubMed

Qin, Jia-Bi; Sheng, Xiao-Qi; Wang, Hua; Chen, Guo-Chong; Yang, Jing; Yu, Hong; Yang, Tu-Bao

2017-03-01

To perform a systematic review and meta-analysis of reported estimates of adverse pregnancy outcomes among multiple births conceived with in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). PubMed, Google Scholar, Cochrane Libraries and Chinese databases were searched through May 2016 for cohort studies assessing adverse pregnancy outcomes associated with IVF/ICSI multiple births. Random-effects meta-analyses were used to calculate pooled estimates of adverse pregnancy outcomes and, where appropriate, heterogeneity was explored in group-specific analyses. Sixty-four studies, with 60,210 IVF/ICSI multiple births and 146,737 spontaneously conceived multiple births, were selected for analysis. Among IVF/ICSI multiple births, the pooled estimates were 51.5% [95% confidence interval (CI): 48.7-54.3] for preterm birth, 12.1% (95% CI: 10.4-14.1) for very preterm birth, 49.8% (95% CI: 47.6-52.0) for low birth weight, 8.4% (95% CI: 7.1-9.9) for very low birth weight, 16.2% (95% CI: 12.9-20.1) for small for gestational age, 3.0% (95% CI: 2.5-3.7) for perinatal mortality and 4.7% (95% CI: 4.0-5.6) for congenital malformations. When the data were restricted to twins, the pooled estimates also showed a high prevalence of adverse outcomes. There was a similar prevalence of poor outcomes among multiple births conceived with IVF/ICSI and naturally (all P ≥ 0.0792). Significant differences in different continents, countries, and income groups were found. The IVF/ICSI multiple pregnancies have a high prevalence of adverse pregnancy outcomes. However, population-wide prospective adverse outcomes registries covering the entire world population for IVF/ICSI pregnancies are needed to determine the exact perinatal prevalence.

Does the thyroid-stimulating hormone measured concurrently with first trimester biochemical screening tests predict adverse pregnancy outcomes occurring after 20 weeks gestation?

PubMed

Ong, Gregory S Y; Hadlow, Narelle C; Brown, Suzanne J; Lim, Ee Mun; Walsh, John P

2014-12-01

Maternal hypothyroidism in early pregnancy is associated with adverse outcomes, but not consistently across studies. First trimester screening for chromosomal anomalies is routine in many centers and provides an opportunity to test thyroid function. To determine if thyroid function tests performed with first trimester screening predicts adverse pregnancy outcomes. A cohort study of 2411 women in Western Australia with singleton pregnancies attending first trimester screening between 9 and 14 weeks gestation. We evaluated the association between TSH, free T4, free T3, thyroid antibodies, free beta human chorionic gonadotrophin (β-hCG) and pregnancy associated plasma protein A (PAPP-A) with a composite of adverse pregnancy events as the primary outcome. Secondary outcomes included placenta previa, placental abruption, pre-eclampsia, pregnancy loss after 20 weeks gestation, threatened preterm labor, preterm birth, small size for gestational age, neonatal death, and birth defects. TSH exceeded the 97.5th percentile for the first trimester (2.15 mU/L) in 133 (5.5%) women, including 22 (1%) with TSH above the nonpregnant reference range (4 mU/L) and 5 (0.2%) above 10 mU/L. Adverse outcomes occurred in 327 women (15%). TSH and free T4 did not differ significantly between women with or without adverse pregnancy events. On the multivariate analysis, neither maternal TSH >2.15 mU/L nor TSH as a continuous variable predicted primary or secondary outcomes. Testing maternal TSH as part of first trimester screening does not predict adverse pregnancy outcomes. This may be because in the community setting, mainly mild abnormalities in thyroid function are detected.

Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.

PubMed

Holmskov, Mathilde; Storebø, Ole Jakob; Moreira-Maia, Carlos R; Ramstad, Erica; Magnusson, Frederik Løgstrup; Krogh, Helle B; Groth, Camilla; Gillies, Donna; Zwi, Morris; Skoog, Maria; Gluud, Christian; Simonsen, Erik

2017-01-01

To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review. We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were summarised as risk ratios (RR) with 95% confidence intervals (CI) using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA) was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse events. All trials were at high risk of bias. In parallel group trials, methylphenidate decreased appetite (RR 3.66, 95% CI 2.56 to 5.23) and weight (RR 3.89, 95% CI 1.43 to 10.59). In cross-over trials, methylphenidate increased abdominal pain (RR 1.61, 95% CI 1.27 to 2.04). We found no significant differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes. Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit hyperactivity disorder. No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found.

Usefulness of Myocardial Annular Velocity Change During Mental Stress to Predict Cardiovascular Outcome in Patients With Coronary Artery Disease (From the Responses of Mental Stress-Induced Myocardial Ischemia to Escitalopram Treatment Trial).

PubMed

Alenezi, Fawaz; Brummett, Beverly H; Boyle, Stephen H; Samad, Zainab; Babyak, Michael A; Alzaeim, Nabil; Wilson, Jennifer; Romano, Minna M D; Sun, Julia L; Ersboll, Mads; O'Connor, Christopher M; Velazquez, Eric J; Jiang, Wei

2017-11-01

Mental stress-induced myocardial ischemia is common and a prognostic factor of adverse cardiovascular outcomes in patients with coronary artery disease (CAD). The present study aimed at examining associations between mental stress-induced myocardial annular velocity (MAV) and cardiovascular outcome in patients with CAD. MAV, specifically, diastolic early (e'), diastolic late (a'), and systolic (s') velocities were obtained at rest and during mental stress testing in 224 patients with clinically stable CAD. Using Cox regression models, age, sex, and baseline-adjusted mental stress-induced MAV measures were examined as predictors of a priori defined composite event term that comprised all-cause mortality and/or nonfatal cardiovascular events, resulting in an unplanned hospitalization (major adverse cardiovascular events [MACE]). Median follow-up was 4 years. The sample was predominantly male, Caucasian with New York Heart Association functional class I and a mean age of 63 ± 10.2 years. MS-induced changes in e' (hazard ratio [HR] = .73) and s' (HR = .73) were significant (p <0.05) predictors of MACE, and the change in a' (HR = .74) was marginal (p = 0.05). The pattern of the relation for each MAV measure was such that patients with a greater decrease in e' and/or s' velocity had a higher probability of experiencing an MACE, and the association of the change in a' and MACE was marginal (p = 0.05), but the same tendency. The associations between MS-induced values of e' and a' for MACE were independent of resting levels. Mental stress-induced MAV changes independently predict an adverse cardiovascular outcome in patients with stable CAD. Copyright © 2017 Elsevier Inc. All rights reserved.

Maternal Dietary L-Arginine and Adverse Birth Outcomes in Dar es Salaam, Tanzania.

PubMed

Darling, Anne Marie; McDonald, Chloe R; Urassa, Willy S; Kain, Kevin C; Mwiru, Ramadhani S; Fawzi, Wafaie W

2017-09-01

The amino acid arginine is a physiological precursor to nitric oxide, which is a key mediator of embryonic survival, fetal growth, and pregnancy maintenance. We evaluated the association between consumption of the amino acid arginine and the rate of adverse birth outcomes using data from a double-blind, randomized, placebo-controlled micronutrient supplementation trial among pregnant women in Dar es Salaam, Tanzania (2001-2004). Dietary intakes of arginine were assessed using repeated 24-hour recalls that were administered throughout pregnancy. Participants (n = 7,591) were monitored by research midwives throughout follow-up to assess pregnancy outcomes. Cubic-restricted splines and multivariable log-Poisson regression with empirical standard errors were used to estimate the continuous and categorical associations between arginine intake and adverse birth outcomes. Compared with women within the lowest quintile of arginine intake, those within the highest quintile had 0.79 times the risk of preterm birth before 37 weeks (95% confidence interval: 0.63, 1.00; P = 0.03). The continuous associations of arginine intake with preterm birth before 37 weeks and with preterm birth before 34 weeks were characterized by an initial rapid decrease in risk with increasing intake (P for nonlinearity < 0.01). Arginine intake was not associated with fetal loss or giving birth to infants who were born small for their gestational ages. This data suggest that the association between dietary arginine intake and preterm birth warrants further investigation. © The Author(s) 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Early cranial ultrasound changes as predictors of outcome during first year of life in term infants with perinatal asphyxia.

PubMed

Boo, N Y; Chandran, V; Zulfiqar, M A; Zamratol, S M; Nyein, M K; Haliza, M S; Lye, M S

2000-08-01

To identify the types of early cranial ultrasound changes that were significant predictors of adverse outcome during the first year of life in asphyxiated term infants. This was a prospective cohort study. Shortly after birth, cranial ultrasonography was carried out via the anterior fontanelles of 70 normal control infants and 104 asphyxiated infants with a history of fetal distress and Apgar scores of less than 6 at 1 and 5 min of life, or requiring endotracheal intubation and manual intermittent positive pressure ventilation for at least 5 min after birth. Neurodevelopmental assessment was carried out on the survivors at 1 year of age. Abnormal cranial ultrasound changes were detected in a significantly higher proportion (79.8%, or n = 83) of asphyxiated infants than controls (39.5%, or n = 30) (P < 0.0001). However, logistic regression analysis showed that only three factors were significantly associated with adverse outcome at 1 year of life among the asphyxiated infants. These were: (i) decreasing birthweight (for every additional gram of increase in birthweight, adjusted odds ratio (OR) = 0.999, 95% confidence interval (CI) 0.998, 1.000; P = 0.047); (ii) a history of receiving ventilatory support during the neonatal period (adjusted OR = 8.3; 95%CI 2.4, 28.9; P = 0.0009); and (iii) hypoxic-ischaemic encephalopathy stage 2 or 3 (adjusted OR = 5.8; 95%CI 1.8, 18.6; P = 0.003). None of the early cranial ultrasound changes was a significant predictor. Early cranial ultrasound findings, although common in asphyxiated infants, were not significant predictors of adverse outcome during the first year of life in asphyxiated term infants.

Clinical Outcomes of Transplanted Modified Bone Marrow-Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study.

PubMed

Steinberg, Gary K; Kondziolka, Douglas; Wechsler, Lawrence R; Lunsford, L Dade; Coburn, Maria L; Billigen, Julia B; Kim, Anthony S; Johnson, Jeremiah N; Bates, Damien; King, Bill; Case, Casey; McGrogan, Michael; Yankee, Ernest W; Schwartz, Neil E

2016-07-01

Preclinical data suggest that cell-based therapies have the potential to improve stroke outcomes. Eighteen patients with stable, chronic stroke were enrolled in a 2-year, open-label, single-arm study to evaluate the safety and clinical outcomes of surgical transplantation of modified bone marrow-derived mesenchymal stem cells (SB623). All patients in the safety population (N=18) experienced at least 1 treatment-emergent adverse event. Six patients experienced 6 serious treatment-emergent adverse events; 2 were probably or definitely related to surgical procedure; none were related to cell treatment. All serious treatment-emergent adverse events resolved without sequelae. There were no dose-limiting toxicities or deaths. Sixteen patients completed 12 months of follow-up at the time of this analysis. Significant improvement from baseline (mean) was reported for: (1) European Stroke Scale: mean increase 6.88 (95% confidence interval, 3.5-10.3; P<0.001), (2) National Institutes of Health Stroke Scale: mean decrease 2.00 (95% confidence interval, -2.7 to -1.3; P<0.001), (3) Fugl-Meyer total score: mean increase 19.20 (95% confidence interval, 11.4-27.0; P<0.001), and (4) Fugl-Meyer motor function total score: mean increase 11.40 (95% confidence interval, 4.6-18.2; P<0.001). No changes were observed in modified Rankin Scale. The area of magnetic resonance T2 fluid-attenuated inversion recovery signal change in the ipsilateral cortex 1 week after implantation significantly correlated with clinical improvement at 12 months (P<0.001 for European Stroke Scale). In this interim report, SB623 cells were safe and associated with improvement in clinical outcome end points at 12 months. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01287936. © 2016 American Heart Association, Inc.

Safety of alternate day fasting and effect on disordered eating behaviors.

PubMed

Hoddy, Kristin K; Kroeger, Cynthia M; Trepanowski, John F; Barnosky, Adrienne R; Bhutani, Surabhi; Varady, Krista A

2015-05-06

Alternate day fasting (ADF; ad libitum intake "feed day" alternated with 75% restriction "fast day"), is effective for weight loss, but the safety of the diet has been questioned. Accordingly, this study examined occurrences of adverse events and eating disorder symptoms during ADF. Obese subjects (n = 59) participated in an 8-week ADF protocol where food was provided on the fast day. Body weight decreased (P < 0.0001) by 4.2 ± 0.3%. Some subjects reported constipation (17%), water retention (2%), dizziness (<20%), and general weakness (<15%). Bad breath doubled from baseline (14%) to post-treatment (29%), though not significantly. Depression and binge eating decreased (P < 0.01) with ADF. Purgative behavior and fear of fatness remained unchanged. ADF helped subjects increase (P < 0.01) restrictive eating and improve (P < 0.01) body image perception. Therefore, ADF produces minimal adverse outcomes, and has either benign or beneficial effects on eating disorder symptoms.

[Severe Adverse Pregnancy Outcomes in Placenta Previa and Prior Cesarean Delivery].

PubMed

Zhou, Mi; Chen, Meng; Zhang, Li; He, Guo-Lin; He, Lei; Wei, Qiang; Li, Tao; Liu, Xing-Hui

2017-09-01

To investigate the severe adverse pregnancy outcomes in pregnancies with placenta previa and prior cesarean delivery and its risk factors. This retrospective casecontrol study reviewed all pregnancies with placenta previa and prior cesarean delivery delivered by repeat cesarean section in our institution between January 2005 and June 2015,and investigated the incidence of severe adverse pregnancy outcome. A composite of severe adverse pregnancy outcomes (including transfusion of 10 units or more red blood cells,maternal ICU admission,unanticipated injuries,repeat operation,hysterectomy,and maternal death) and other maternal and neonatal outcomes were described. Univariate and multivariable logistic regression analysis were used to quantify the effects of risk factors on severe adverse pregnancy outcomes. There were 478 women with placenta previa and prior cesarean delivery in our hospital over the last decade. The average age of them was 32.5±4.8 years old,most women were beyond 30 years old,the average gravidity and parity were 4 and 1,131 cases (27.4%) had severe adverse pregnancy outcomes. Transfusion of 10 units or more red blood cells happened in 75 cases (15.7%,75/478); 44 cases (9.2%,44/478) necessitated maternal ICU admission; unanticipated bladder injury occurred in 11 cases,but non ureter or bowel injury happened; All 4 repeat operations were due to delayed hemorrhage after conservative management during cesarean delivery,and an emergent hysterectomy was performed for all of the 4 cases. Hysterectomy (107 cases,22.4%) was the most common severe adverse pregnancy outcome. Among all 311 morbidly adherent placenta cases finally confirmed by pathological or surgical findings or both,only 172 (55.3%) were suspected before delivery. Multivariable logistic regression analysis showed that the risk of severe adverse pregnancy outcomes was significantly increased by pernicious placenta previa (i.e. anterior placenta overlying the prior cesarean scar),suspicion of morbidly adherent placenta before delivery and hemoglobin before delivery lower than 100 g/L,and the corresponding odds ratios and 95% confidence intervals were 2.4 (1.5-3.8),3.6 (2.3-5.6) and 2.5 (1.6-3.9),respectively. Pernicious placenta previa,suspicion of morbidly adherent placenta before delivery and hemoglobin before delivery lower than 100 g/L were associated with severe adverse pregnancy outcomes in women with placenta previa and prior cesarean delivery .

No increased risk of major congenital anomalies or adverse pregnancy or neonatal outcomes following letrozole use in assisted reproductive technology.

PubMed

Tatsumi, T; Jwa, S C; Kuwahara, A; Irahara, M; Kubota, T; Saito, H

2017-01-01

Does letrozole use increase the risk of major congenital anomalies and adverse pregnancy and neonatal outcomes in fresh, single-embryo transfer? Letrozole significantly decreases the risk of miscarriage and does not increase the risk of major congenital anomalies or adverse pregnancy or neonatal outcomes compared with natural cycles in patients undergoing ART. Letrozole is the most commonly used aromatase inhibitor for mild ovarian stimulation in ART. However, its safety in terms of pregnancy and neonatal outcomes is unclear. This retrospective cohort study used data from the Japanese national ART registry from 2011 to 2013. A total of 3136 natural cycles and 792 letrozole-induced cycles associated with fresh, single-embryo transfer and resulting in a clinical pregnancy were included in the analysis. The main pregnancy outcomes were miscarriage, ectopic pregnancy and still birth, and the neonatal outcomes were preterm delivery, low birth weight, small/large for gestational age and major congenital anomalies. Terminated pregnancies were included in the analysis of major congenital anomalies. Odds ratios (ORs) and 95% CIs were calculated using multivariate logistic regression analysis adjusted for maternal age and calendar year. The risk of miscarriage was significantly lower in women administered letrozole (adjusted OR [aOR], 0.37, 95% CI, 0.30-0.47, P < 0.001). There was no significant difference in the overall risk of major congenital anomalies between the two groups (natural cycle 1.5% vs letrozole 1.9%, aOR, 1.24, 95% CI, 0.64-2.40, P = 0.52), and no increased risk for any specific organ system. Subgroup analysis demonstrated that the risk of major congenital anomalies was not increased in patients who underwent either in vitro fertilization or ICSI, or in those who received early cleavage stage or blastocyst embryo transfer. All other pregnancy and neonatal outcomes were comparable between the two groups. Despite the large sample size, we were only able to rule out the possibility that letrozole might cause large increases in birth-defect risks in ART patients. The results suggest that letrozole stimulation reduces the risk of miscarriage, with no increase in the risk of major congenital anomalies or adverse pregnancy or neonatal outcomes compared with natural cycles in women undergoing ART. Letrozole may thus be a safe option for mild ovarian stimulation. None. Not applicable. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Adverse pregnancy outcomes in women with nausea and vomiting of pregnancy.

PubMed

Temming, Lorene; Franco, Albert; Istwan, Niki; Rhea, Debbie; Desch, Cheryl; Stanziano, Gary; Joy, Saju

2014-01-01

To examine the influence of nausea and vomiting of pregnancy (NVP) on pregnancy outcomes. Outcomes were compared for primigravidas with a current singleton gestation enrolled at <20 weeks' gestation in a maternity risk screening and education program (n = 81 486). Patient-reported maternal characteristics and pregnancy outcomes were compared for women with and without NVP and within the NVP group for those with and without poor weight gain. 6.4% of women reported NVP as a pregnancy complication. Women reporting NVP were more likely to be younger, obese, single and smoke. They had higher rates of preterm delivery, pregnancy-induced hypertension and low birth weight <2500 g. Almost one-quarter of women with NVP had lower than recommended weight gain. Poor weight gain was associated with a higher incidence of adverse outcomes. Obesity, tobacco use and poor pregnancy weight gain independently increased the odds of an adverse outcome. NVP and subsequent poor weight gain may be associated with adverse pregnancy outcomes.

Physical, behavioral, and cognitive effects of prenatal tobacco and postnatal secondhand smoke exposure.

PubMed

Zhou, Sherry; Rosenthal, David G; Sherman, Scott; Zelikoff, Judith; Gordon, Terry; Weitzman, Michael

2014-09-01

The purpose of this review is to examine the rapidly expanding literature regarding the effects of prenatal tobacco and postnatal secondhand smoke (SHS) exposure on child health and development. Mechanisms of SHS exposure are reviewed, including critical periods during which exposure to tobacco products appears to be particularly harmful to the developing fetus and child. The biological, biochemical, and neurologic effects of the small fraction of identified components of SHS are described. Research describing these adverse effects of both in utero and childhood exposure is reviewed, including findings from both animal models and humans. The following adverse physical outcomes are discussed: sudden infant death syndrome, low birth weight, decreased head circumference, respiratory infections, otitis media, asthma, childhood cancer, hearing loss, dental caries, and the metabolic syndrome. In addition, the association between the following adverse cognitive and behavioral outcomes and such exposures is described: conduct disorder, attention-deficit/hyperactivity disorder, poor academic achievement, and cognitive impairment. The evidence supporting the adverse effects of SHS exposure is extensive yet rapidly expanding due to improving technology and increased awareness of this profound public health problem. The growing use of alternative tobacco products, such as hookahs (a.k.a. waterpipes), and the scant literature on possible effects from prenatal and secondhand smoke exposure from these products are also discussed. A review of the current knowledge of this important subject has implications for future research as well as public policy and clinical practice. Published by Mosby, Inc.

Association between the high soluble fms-like tyrosine kinase-1 to placental growth factor ratio and adverse outcomes in asymptomatic women with early-onset fetal growth restriction.

PubMed

Shinohara, Satoshi; Uchida, Yuzo; Kasai, Mayuko; Sunami, Rei

2017-08-01

To assess whether the high soluble fms-like tyrosine kinase-1 (sFlt-1) to placental growth factor (PlGF) ratio is associated with adverse outcomes (e.g., HELLP syndrome [hemolysis, elevated liver enzymes, and low platelets], severe hypertension uncontrolled by medication, non-reassuring fetal status, placental abruption, pulmonary edema, growth arrest, maternal death, or fetal death) and a shorter duration to delivery in early-onset fetal growth restriction (FGR). Thirty-four women with FGR diagnosed at <34.0 weeks were recruited. Serum angiogenic marker levels were estimated within 6 hours of a diagnosis of FGR. A receiver operating characteristic curve was used to determine the threshold of the sFlt-1/PlGF ratio to predict adverse outcomes. We used multivariable logistic regression analysis to examine the association between the sFlt-1/PlGF ratio and adverse outcomes. Finally, we used Kaplan-Meier analysis and the log-rank test to assess the probability of delay in delivery. Women who developed adverse outcomes within a week had a significantly higher sFlt-1/PlGF ratio than did those who did not develop complications. A cutoff value of 86.2 for the sFlt-1/PlGF ratio predicted adverse outcomes, with a sensitivity and specificity of 77.8% and 80.0%, respectively. Moreover, 58.4% of women with an sFlt-1/PlGF ratio ≥86.2 versus 9.1% of those with an sFlt-1/PlGF ratio <86.2 delivered within a week of presentation (p < 0.001). In multivariate analyses, an sFlt-1/PlGF ratio ≥86.2 (adjusted odds ratio 9.52; 95% confidence interval, 1.25-72.8) was associated with adverse maternal and neonatal outcomes. A high sFlt-1/PlGF ratio was associated with adverse outcomes and a shorter duration to delivery in early-onset FGR.

Heterogeneity and the effect of mental health parity mandates on the labor market.

PubMed

Andersen, Martin

2015-09-01

Health insurance benefit mandates are believed to have adverse effects on the labor market, but efforts to document such effects for mental health parity mandates have had limited success. I show that one reason for this failure is that the association between parity mandates and labor market outcomes vary with mental distress. Accounting for this heterogeneity, I find adverse labor market effects for non-distressed individuals, but favorable effects for moderately distressed individuals and individuals with a moderately distressed family member. On net, I conclude that the mandates are welfare increasing for moderately distressed workers and their families, but may be welfare decreasing for non-distressed individuals. Copyright © 2015 Elsevier B.V. All rights reserved.

Characteristic features of tacrolimus-induced lung disease in rheumatoid arthritis patients.

PubMed

Sasaki, Takanori; Nakamura, Wataru; Inokuma, Shigeko; Matsubara, Erika

2016-02-01

This paper aims to study the background and clinical characteristics of tacrolimus (TAC)-induced lung disease. A case of a rheumatoid arthritis (RA) patient who developed TAC-induced interstitial lung disease (TAC-ILD) is reported. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) website was searched for cases of TAC-ILD and its prevalence among all cases of TAC-related adverse events. As for cases of TAC-ILD, its underlying disease, preexisting lung diseases, and fatal outcome were also searched. Literature review of TAC-ILD cases was added. A 65-year-old female RA patient with preexisting bronchiectasis developed near-fatal TAC-ILD. Amelioration of RA, ground-glass opacities in the upper, anterior, and central lung fields, and decrease in peripheral blood lymphocyte count were the major findings in this patient. A search of the PMDA website revealed the following: the prevalence of TAC-ILD was 3 % of all cases of TAC-related adverse events, 56 out of 85 RA cases (66 %), and one out of 15 other cases had a preexisting lung disease; the prevalences of fatal outcome in RA and other cases were 24 and 38 %, respectively. A few cases in the literature had preexisting ILD and developed diffuse alveolar damage. In our case, preexisting bronchiectasis, arthritis remission, newly developed ground-glass opacities (GGOs) in the upper, anterior, and central lung fields, and decrease in peripheral blood lymphocyte count were the major findings. From the search of the PMDA website, about one fourth of the cases with TAC-related lung injury had a fatal outcome, and among RA patients, two thirds had preexisting lung diseases.

Renal Outcomes and Dietary Potassium: The Overshadowed Electrolyte?

PubMed Central

Jablonski, Kristen L.; Kendrick, Jessica

2014-01-01

Smyth et al. examined the association between urinary sodium and potassium excretion and adverse renal outcomes in adults at high cardiovascular risk. They found no association between urinary sodium excretion and adverse renal outcomes, but a reduced odds of adverse renal outcomes with higher urinary potassium excretion. This finding is quite interesting and a major advancement from this study. It will be important to ascertain whether this finding holds true in individuals free from vascular disease and diabetes, as well as in patients with chronic kidney disease. PMID:25427082

Experience of switching from a traditional sitting workstation to a sit-stand workstation in sedentary office workers.

PubMed

Dutta, Nirjhar; Walton, Thomas; Pereira, Mark A

2015-01-01

Prolonged sedentary time (ST) is associated with adverse health outcomes, while decreasing ST improves health outcomes. The use of sit-stand desks (SSDs) in workplaces has been proposed as a means of reducing ST. The purpose of this study was to gain knowledge about participants' experience and perceptions of a workplace intervention involving the introduction of SSDs. Focus groups and interviews were conducted with 28 study participants who used SSDs for 4 weeks. Data were analyzed using a grounded theory approach. Participants reported a high level of satisfaction with the SSDs and 96% chose to use them permanently. Participants experienced greater energy and alertness at work and reported increased face-to-face interaction with coworkers. Lack of work-surface space was the most significant problem with the use of SSDs. There was no perception of decreased productivity or reduced workplace privacy among participants.

Risk factor assessment of endoscopically removed malignant colorectal polyps.

PubMed

Netzer, P; Forster, C; Biral, R; Ruchti, C; Neuweiler, J; Stauffer, E; Schönegg, R; Maurer, C; Hüsler, J; Halter, F; Schmassmann, A

1998-11-01

Malignant colorectal polyps are defined as endoscopically removed polyps with cancerous tissue which has invaded the submucosa. Various histological criteria exist for managing these patients. To determine the significance of histological findings of patients with malignant polyps. Five pathologists reviewed the specimens of 85 patients initially diagnosed with malignant polyps. High risk malignant polyps were defined as having one of the following: incomplete polypectomy, a margin not clearly cancer-free, lymphatic or venous invasion, or grade III carcinoma. Adverse outcome was defined as residual cancer in a resection specimen and local or metastatic recurrence in the follow up period (mean 67 months). Malignant polyps were confirmed in 70 cases. In the 32 low risk malignant polyps, no adverse outcomes occurred; 16 (42%) of the 38 patients with high risk polyps had adverse outcomes (p<0.001). Independent adverse risk factors were incomplete polypectomy and a resected margin not clearly cancer-free; all other risk factors were only associated with adverse outcome when in combination. As no patients with low risk malignant polyps had adverse outcomes, polypectomy alone seems sufficient for these cases. In the high risk group, surgery is recommended when either of the two independent risk factors, incomplete polypectomy or a resection margin not clearly cancer-free, is present or if there is a combination of other risk factors. As lymphatic or venous invasion or grade III cancer did not have an adverse outcome when the sole risk factor, operations in such cases should be individually assessed on the basis of surgical risk.

Accelerating Adverse Outcome Pathway Development Using Publicly Available Data Sources

EPA Science Inventory

The adverse outcome pathway (AOP) concept links molecular perturbations with organism and population-level outcomes to support high-throughput toxicity testing. International efforts are underway to define AOPs and store the information supporting these AOPs in a central knowledg...

Obstetrical complications associated with abnormal maternal serum markers analytes.

PubMed

Gagnon, Alain; Wilson, R Douglas

2008-10-01

To review the obstetrical outcomes associated with abnormally elevated or decreased level of one or more of the most frequently measured maternal serum marker analytes used in screening for aneuploidy. To provide guidance to facilitate the management of pregnancies that have abnormal levels of one of more markers and to assess the usefulness of these markers as a screening test. Perinatal outcomes associated with abnormal levels of maternal serum markers analytes are compared with the outcomes of pregnancies with normal levels of the same analytes or the general population. The Cochrane Library and Medline were searched for English-language articles published from 1966 to February 2007, relating to maternal serum markers and perinatal outcomes. Search terms included PAPP-A (pregnancy associated plasma protein A), AFP (alphafetoprotein), hCG (human chorionic gonadotropin), estriol, unconjugated estriol, inhibin, inhibin-A, maternal serum screen, triple marker screen, quadruple screen, integrated prenatal screen, first trimester screen, and combined prenatal screen. All study types were reviewed. Randomized controlled trials were considered evidence of the highest quality, followed by cohort studies. Key individual studies on which the recommendations are based are referenced. Supporting data for each recommendation are summarized with evaluative comments and references. The evidence was evaluated using the guidelines developed by the Canadian Task Force on Preventive Health Care. The evidence collected was reviewed by the Genetics Committee of the Society of Obstetricians and Gynaecologists of Canada. The benefit expected from this guideline is to facilitate early detection of potential adverse pregnancy outcomes when risks are identified at the time of a maternal serum screen. It will help further stratification of risk and provide options for pregnancy management to minimize the impact of pregnancy complications. The potential harms resulting from such practice are associated with the so called false positive (i.e., uncomplicated pregnancies labelled at increased risk for adverse perinatal outcomes), the potential stress associated with such a label, and the investigations performed for surveillance in this situation. No cost-benefit analysis is available to assess costs and savings associated with this guideline. SUMMARY STATEMENTS: 1. An unexplained level of a maternal serum marker analyte is defined as an abnormal level after confirmation of gestational age by ultrasound and exclusion of maternal, fetal, or placental causes for the abnormal level. (III) 2. Abnormally elevated levels of serum markers are associated with adverse pregnancy outcomes in twin pregnancies, after correction for the number of fetuses. Spontaneous or planned mutifetal reductions may result in abnormal elevations of serum markers. (II-2) RECOMMENDATIONS: 1. In the first trimester, an unexplained low PAPP-A (< 0.4 MoM) and/or a low hCG (< 0.5 MoM) are associated with an increased frequency of adverse obstetrical outcomes, and, at present, no specific protocol for treatment is available. (II-2A) In the second trimester, an unexplained elevation of maternal serum AFP (> 2.5 MoM), hCG (> 3.0 MoM), and/or inhibin-A (> or =2.0 MoM) or a decreased level of maternal serum AFP (< 0.25 MoM) and/or unconjugated estriol (< 0.5 MoM) are associated with an increased frequency of adverse obstetrical outcomes, and, at present, no specific protocol for treatment is available. (II-2A) 2. Pregnant woman with an unexplained elevated PAPP-A or hCG in the first trimester and an unexplained low hCG or inhibin-A and an unexplained elevated unconjugated estriol in the second trimester should receive normal antenatal care, as this pattern of analytes is not associated with adverse perinatal outcomes. (II-2A) 3. The combination of second or third trimester placenta previa and an unexplained elevated maternal serum AFP should increase the index of suspicion for placenta accreta, increta, or percreta. (II-2B) An assessment (ultrasound, MRI) of the placental-uterine interface should be performed. Abnormal invasion should be strongly suspected, and the planning of delivery location and technique should be done accordingly. (III-C) 4. A prenatal consultation with the medical genetics department is recommended for low unconjugated estriol levels (<0.3 MoM), as this analyte pattern can be associated with genetic conditions. (II-2B) 5. The clinical management protocol for identification of potential adverse obstetrical outcomes should be guided by one or more abnormal maternal serum marker analyte value rather than the false positive screening results for the trisomy 21 and/or the trisomy 18 screen. (II-2B) 6. Pregnant woman who are undergoing renal dialysis or who have had a renal transplant should be offered maternal serum screening, but interpretation of the result is difficult as the level of serum hCG is not reliable. (II-2A) 7. Abnormal maternal uterine artery Doppler in association with elevated maternal serum AFP, hCG, or inhibin-A or decreased PAPP-A identifies a group of women at greater risk of IUGR and gestational hypertension with proteinuria. Uterine artery Doppler measurements may be used in the evaluation of an unexplained abnormal level of either of these markers. (II-2B) 8. Further research is recommended to identify the best protocol for pregnancy management and surveillance in women identified at increased risk of adverse pregnancy outcomes based on an abnormality of a maternal serum screening analyte. (III-A) 9. In the absence of evidence supporting any specific surveillance protocol, an obstetrician should be consulted in order to establish a fetal surveillance plan specific to the increased obstetrical risks (maternal and fetal) identified. This plan may include enhanced patient education on signs and symptoms of the most common complications, increased frequency of antenatal visits, increased ultrasound (fetal growth, amniotic fluid levels), and fetal surveillance (biophysical profile, arterial and venous Doppler), and cervical length assessment. (III-A) 10. Limited information suggests that, in women with elevated hCG in the second trimester and/or abnormal uterine artery Doppler (at 22-24 weeks), low-dose aspirin (60-81 mg daily) is associated with higher birthweight and lower incidence of gestational hypertension with proteinuria. This therapy may be used in women who are at risk. (II-2B) 11. Further studies are recommended in order to assess the benefits of low-dose aspirin, low molecular weight heparin, or other therapeutic options in pregnancies determined to be at increased risk on the basis of an abnormal maternal serum screening analyte. (III-A) 12. Multiple maternal serum markers screening should not be used at present as a population-based screening method for adverse pregnancy outcomes (such as preeclampsia, placental abruption, and stillbirth) outside an established research protocol, as sensitivity is low, false positive rates are high, and no management protocol has been shown to clearly improve outcomes. (II-2D) When maternal serum screening is performed for the usual clinical indication (fetal aneuploidy and/or neural tube defect), abnormal analyte results can be utilized for the identification of pregnancies at risk and to direct their clinical management. (II-2B) Further studies are recommended to determine the optimal screening method for poor maternal and/or perinatal outcomes. (III-A).

B-type natriuretic peptide and cardiac troponin I are associated with adverse outcomes in stable kidney transplant recipients

USDA-ARS?s Scientific Manuscript database

BACKGROUND: Approximately 200 000 kidney transplant recipients are living in the United States; they are at increased risk for cardiovascular and other adverse outcomes. Biomarkers predicting these outcomes are needed. Using specimens collected during the Folic Acid for Vascular Outcome Reduction in...

A Workflow to Investigate Exposure and Pharmacokinetic Influences on High-Throughput in Vitro Chemical Screening Based on Adverse Outcome Pathways

EPA Science Inventory

Background: Adverse outcome pathways (AOPs) link adverse effects in individuals or populations to a molecular initiating event (MIE) that can be quantified using in vitro methods. Practical application of AOPs in chemical-specific risk assessment requires incorporation of knowled...

Long-term outcomes of twins based on the intended mode of delivery.

PubMed

Fox, Nathan S; Cohen, Natalie; Odom, Elizabeth; Gupta, Simi; Lam-Rachlin, Jennifer; Saltzman, Daniel H; Rebarber, Andrei

2018-08-01

Recent studies have shown that for twin pregnancies with a cephalic presenting first twin, planned vaginal delivery is not associated with adverse short-term neonatal outcomes, as compared to planned cesarean delivery. Our objective was to compare long-term outcomes in twins, based on planned mode of delivery. This was a prospective, observational cohort of twin pregnancies delivered by a single MFM practice. All the patients with a twin pregnancy >34 weeks delivered from 2005-2014 were surveyed regarding pediatric outcomes at or after 2 years of life. The survey was mail-based, with phone follow-up for nonresponses or for clarification of answers. Using chi-square, Student's t-tests, and regression analysis we compared outcomes between women who planned a vaginal (with active management of the second stage) versus cesarean delivery. The main outcome measures were: (1) a composite of major adverse outcomes (death, cerebral palsy, necrotizing enterocolitis, chronic renal, heart, or lung disease); (2) a composite of minor adverse outcomes (learning disability, speech therapy, occupational therapy, physical therapy). Five hundred and thirty-two women met inclusion criteria and 354 (66.5%) responded. 178 (50.3%) women planned to have a cesarean delivery (100% of whom had a cesarean delivery) and 176 (49.7%) women planned to have a vaginal delivery (83% of whom had a vaginal delivery). The average age of the children at the time of the survey was 5.9 years. There were no differences in any pediatric outcomes between the two groups. After controlling for maternal age, IVF, obesity, and preeclampsia, the planned mode of delivery was not associated with a composite of major adverse outcomes (aOR 0.673, 95% CI 0.228, 1.985), nor a composite of minor adverse outcomes (aOR 0.767, 95% CI 0.496, 1.188). Planned vaginal delivery with active management of the second stage of labor in twin pregnancies >34 weeks is not associated with adverse childhood outcomes.

Intestinal Microbiota in Pediatric Surgical Cases Administered Bifidobacterium Breve: A Randomized Controlled Trial.

PubMed

Okazaki, Tadaharu; Asahara, Takashi; Yamataka, Atsuyuki; Ogasawara, Yuki; Lane, Geoffrey J; Nomoto, Koji; Nagata, Satoru; Yamashiro, Yuichiro

2016-07-01

The efficacy of perioperative probiotic administration has been reported in adults. We examined the effects of orally administered Bifidobacterium breve strain Yakult (BBG-01) on outcomes in pediatric surgical cases by assessing intestinal and blood microbiota. BBG-01 was well tolerated without adverse effects, and postoperative infectious complications were significantly decreased. Fecal analysis showed increased Bifidobacterium and decreased Enterobacteriaceae, Clostridium difficile, and Pseudomonas. Concentrations of fecal acetic acid were significantly increased, maintaining fecal pH at <7.0. The incidence of detecting bacteria in blood was significantly reduced. BBG-01 improved the intestinal environment, and may be implicated in suppressing bacterial translocation.

Tolerability of buprenorphine transdermal system in nursing home patients with advanced dementia: a randomized, placebo-controlled trial (DEP.PAIN.DEM).

PubMed

Erdal, Ane; Flo, Elisabeth; Aarsland, Dag; Selbaek, Geir; Ballard, Clive; Slettebo, Dagrun D; Husebo, Bettina S

2018-01-01

Buprenorphine transdermal system is increasingly prescribed in people with advanced dementia, but no clinical trial has investigated the safety and factors associated with discontinuation due to adverse events in this population. One hundred sixty-two people with advanced dementia and significant depression from 47 nursing homes were included and randomized to active analgesic treatment (acetaminophen/buprenorphine) or identical placebo for 13 weeks. In this secondary analysis, the main outcomes were time to and reasons for discontinuation of buprenorphine due to adverse events. Change in daytime activity as measured by actigraphy was a secondary outcome. Of the 44 patients who received active buprenorphine 5 µg/hour, 52.3% (n=23) discontinued treatment due to adverse events compared to 13.3% (6 of 45) in the placebo group ( p <0.001). Psychiatric and neurological adverse events were the most frequently reported causes of discontinuation (69.6%, n=16). Concomitant use of antidepressants significantly increased the risk of discontinuation (HR 23.2, 95% CI: 2.95-182, p =0.003). Adjusted for age, sex, cognitive function, pain and depression at baseline, active buprenorphine was associated with 24.0 times increased risk of discontinuation (Cox model, 95% CI: 2.45-235, p =0.006). Daytime activity dropped significantly during the second day of active treatment (-21.4%, p =0.005) and decreased by 12.9% during the first week ( p =0.053). Active buprenorphine had significantly higher risk of discontinuation compared with placebo in people with advanced dementia and depression, mainly due to psychiatric and neurological adverse events. Daytime activity dropped significantly during the first week of treatment. Concomitant use of antidepressants further reduced the tolerability of buprenorphine.

Informatics approaches in the Biological Characterization of Adverse Outcome Pathways

EPA Science Inventory

Adverse Outcome Pathways (AOPs) are a conceptual framework to characterize toxicity pathways by a series of mechanistic steps from a molecular initiating event to population outcomes. This framework helps to direct risk assessment research, for example by aiding in computational ...

The effects of nitroglycerin during cardiopulmonary resuscitation.

PubMed

Stefaniotou, Antonia; Varvarousi, Giolanda; Varvarousis, Dimitrios P; Xanthos, Theodoros

2014-07-05

The outcome for both in-hospital and out-of hospital cardiac arrest remains dismal. Vasopressors are used to increase coronary perfusion pressure and thus facilitate return of spontaneous circulation during cardiopulmonary resuscitation. However, they are associated with a number of potential adverse effects and may decrease endocardial and cerebral organ blood flow. Nitroglycerin has a favourable haemodynamic profile which promotes forward blood flow. Several studies suggest that combined use of nitroglycerin with vasopressors during resuscitation, is associated with increased rates of resuscitation and improved post-resuscitation outcome. This article reviews the effects of nitroglycerin during cardiopulmonary resuscitation and postresuscitation period, as well as the beneficial outcomes of a combination regimen consisting of a vasopressor and a vasodilator, such as nitroglycerin. Copyright © 2014 Elsevier B.V. All rights reserved.

Efficacy and tolerability of paliperidone ER in patients with unsatisfactorily controlled schizophrenia by other antipsychotics: a flexible-dose approach

PubMed Central

Mauri, Massimo C.; Adami, Marina; Reggiardo, Giorgio; Giulio, Corrivetti

2015-01-01

This study evaluates the effectiveness of paliperidone ER in patients with symptomatic but not highly acute schizophrenia in terms of efficacy, safety, and patients’ perception of their social functioning and well-being. This is a multicenter, open-label prospective study with a flexible-dose approach; 133 patients were enrolled and followed for 13 weeks after switching to paliperidone ER. Outcome efficacy measures were as follows: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity (CGI-S) scale, and the Personal and Social Performance (PSP) scale; in addition, the Subjective Well-being under Neuroleptics (SWN-20) scale, the Drug Attitude Inventory (DAI-30), and the sleep evaluation scale were used. Symptom Rating Scale (ESRS), adverse events, and subjective side effects were recorded. 118/133(88.7%) patients completed the study. The mean PANSS score decreased (88.98±10.09 to 66.52±16.29; P<0.001); 40.5% of the patients achieved improvement of at least 30%. PSP and CGI-S scores as well as DAI-30 and SWN-20 decreased (P<0.001). ESRS (P<0.001) decreased significantly from the baseline. Throughout the trial, no deaths occurred and only one serious adverse event was reported. Paliperidone ER has proved to be efficacious, safe, and well tolerated also with this approach more closely resembling actual clinical practice. Patient-relevant outcome parameters such as social functioning and quality of life improved, which is crucial for treatment adherence in clinical practice. PMID:26230269

Efficacy and tolerability of paliperidone ER in patients with unsatisfactorily controlled schizophrenia by other antipsychotics: a flexible-dose approach.

PubMed

Mauri, Mauro; Mauri, Massimo C; Adami, Marina; Reggiardo, Giorgio; Giulio, Corrivetti

2015-11-01

This study evaluates the effectiveness of paliperidone ER in patients with symptomatic but not highly acute schizophrenia in terms of efficacy, safety, and patients' perception of their social functioning and well-being. This is a multicenter, open-label prospective study with a flexible-dose approach; 133 patients were enrolled and followed for 13 weeks after switching to paliperidone ER. Outcome efficacy measures were as follows: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity (CGI-S) scale, and the Personal and Social Performance (PSP) scale; in addition, the Subjective Well-being under Neuroleptics (SWN-20) scale, the Drug Attitude Inventory (DAI-30), and the sleep evaluation scale were used. Symptom Rating Scale (ESRS), adverse events, and subjective side effects were recorded. 118/133(88.7%) patients completed the study. The mean PANSS score decreased (88.98 ± 10.09 to 66.52 ± 16.29; P < 0.001); 40.5% of the patients achieved improvement of at least 30%. PSP and CGI-S scores as well as DAI-30 and SWN-20 decreased (P < 0.001). ESRS (P < 0.001) decreased significantly from the baseline. Throughout the trial, no deaths occurred and only one serious adverse event was reported. Paliperidone ER has proved to be efficacious, safe, and well tolerated also with this approach more closely resembling actual clinical practice. Patient-relevant outcome parameters such as social functioning and quality of life improved, which is crucial for treatment adherence in clinical practice.

The Complement System and Adverse Pregnancy Outcomes

PubMed Central

Regal, Jean F.; Gilbert, Jeffrey S.; Burwick, Richard M.

2015-01-01

Adverse pregnancy outcomes significantly contribute to morbidity and mortality for mother and child, with lifelong health consequences for both. The innate and adaptive immune system must be regulated to insure survival of the feta allograft, and the complement system is no exception. An intact complement system optimizes placental development and function and is essential to maintain host defense and fetal survival. Complement regulation is apparent at the placental interface from early pregnancy with some degree of complement activation occurring normally throughout gestation. However, a number of pregnancy complications including early pregnancy loss, fetal growth restriction, hypertensive disorders of pregnancy and preterm birth are associated with excessive or misdirected complement activation, and are more frequent in women with inherited or acquired complement system disorders or complement gene mutations. Clinical studies employing complement biomarkers in plasma and urine implicate dysregulated complement activation in components of each of the adverse pregnancy outcomes. In addition, mechanistic studies in rat and mouse models of adverse pregnancy outcomes address the complement pathways or activation products of importance and allow critical analysis of the pathophysiology. Targeted complement therapeutics are already in use to control adverse pregnancy outcomes in select situations. A clearer understanding of the role of the complement system in both normal pregnancy and complicated or failed pregnancy will allow a rational approach to future therapeutic strategies for manipulating complement with the goal of mitigating adverse pregnancy outcomes, preserving host defense, and improving long term outcomes for both mother and child. PMID:25802092

Putative adverse outcome pathways relevant to neurotoxicity

PubMed Central

Bal-Price, Anna; Crofton, Kevin M.; Sachana, Magdalini; Shafer, Timothy J.; Behl, Mamta; Forsby, Anna; Hargreaves, Alan; Landesmann, Brigitte; Lein, Pamela J.; Louisse, Jochem; Monnet-Tschudi, Florianne; Paini, Alicia; Rolaki, Alexandra; Schrattenholz, André; Suñol, Cristina; van Thriel, Christoph; Whelan, Maurice; Fritsche, Ellen

2016-01-01

The Adverse Outcome Pathway (AOP) framework provides a template that facilitates understanding of complex biological systems and the pathways of toxicity that result in adverse outcomes (AOs). The AOP starts with an molecular initiating event (MIE) in which a chemical interacts with a biological target(s), followed by a sequential series of KEs, which are cellular, anatomical, and/or functional changes in biological processes, that ultimately result in an AO manifest in individual organisms and populations. It has been developed as a tool for a knowledge-based safety assessment that relies on understanding mechanisms of toxicity, rather than simply observing its adverse outcome. A large number of cellular and molecular processes are known to be crucial to proper development and function of the central (CNS) and peripheral nervous systems (PNS). However, there are relatively few examples of well-documented pathways that include causally linked MIEs and KEs that result in adverse outcomes in the CNS or PNS. As a first step in applying the AOP framework to adverse health outcomes associated with exposure to exogenous neurotoxic substances, the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) organized a workshop (March 2013, Ispra, Italy) to identify potential AOPs relevant to neurotoxic and developmental neurotoxic outcomes. Although the AOPs outlined during the workshop are not fully described, they could serve as a basis for further, more detailed AOP development and evaluation that could be useful to support human health risk assessment in a variety of ways. PMID:25605028

Correlates of adverse childhood events among adults with schizophrenia spectrum disorders.

PubMed

Rosenberg, Stanley D; Lu, Weili; Mueser, Kim T; Jankowski, Mary Kay; Cournos, Francine

2007-02-01

Multiple studies have found that childhood adversity is related to a range of poor mental health, substance abuse, poor physical health, and poor social functioning outcomes in the general population of adults. However, despite the high rates of childhood adversity in schizophrenia, the clinical correlates of these events have not been systematically evaluated. This study evaluated the relationship between adverse experiences in childhood and functional, clinical, and health outcomes among adults with schizophrenia. The authors surveyed 569 adults with schizophrenia regarding adverse childhood events (including physical abuse, sexual abuse, parental mental illnesses, loss of a parent, parental separation or divorce, witnessing domestic violence, and foster or kinship care). The relationships between cumulative exposure to these events and psychiatric, physical, and functional outcomes were evaluated. Increased exposure to adverse childhood events was strongly related to psychiatric problems (suicidal thinking, hospitalizations, distress, and posttraumatic stress disorder), substance abuse, physical health problems (HIV infection), medical service utilization (physician visits), and poor social functioning (homelessness or criminal justice involvement). The findings extend the results of research in the general population by suggesting that childhood adversity contributes to worse mental health, substance abuse, worse physical health, and poor functional outcomes in schizophrenia.

Economic Conditions During Pregnancy and Adverse Birth Outcomes Among Singleton Live Births in the United States, 1990-2013.

PubMed

Margerison-Zilko, Claire E; Li, Yu; Luo, Zhehui

2017-11-15

We know little about the relationship between the macroeconomy and birth outcomes, in part due to the methodological challenge of distinguishing effects of economic conditions on fetal health from effects of economic conditions on selection into live birth. We examined associations between state-level unemployment rates in the first 2 trimesters of pregnancy and adverse birth outcomes, using natality data on singleton live births in the United States during 1990-2013. We used fixed-effect logistic regression models and accounted for selection by adjusting for state-level unemployment before conception and maternal characteristics associated with both selection and birth outcomes. We also tested whether associations between macroeconomic conditions and birth outcomes differed during and after (compared with before) the Great Recession (2007-2009). Each 1-percentage-point increase in the first-trimester unemployment rate was associated with a 5% increase in odds of preterm birth, while second-trimester unemployment was associated with a 3% decrease in preterm birth odds. During the Great Recession, however, first-trimester unemployment was associated with a 16% increase in odds of preterm birth. These findings increase our understanding of the effects of the Great Recession on health and add to growing literature suggesting that macro-level social and economic factors contribute to perinatal health. © The Author(s) 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Perceived social support interacts with prenatal depression to predict birth outcomes.

PubMed

Nylen, Kimberly J; O'Hara, Michael W; Engeldinger, Jane

2013-08-01

Prenatal depression has been linked to adverse reproductive outcomes including preterm labor and delivery, and low birth weight. Social support also has been linked to birth outcomes, and may buffer infants from the adverse impact of maternal depression. In this prospective study, 235 pregnant women completed questionnaires about depression and social support. Clinical interviews were administered to assess for DSM-IV axis I disorders. Following delivery, birth outcomes were obtained from medical records. Babies of depressed mothers weighed less, were born earlier and had lower Apgar scores than babies of nondepressed mothers. Depressed women had smaller social support networks and were less satisfied with support from social networks. We found no direct associations between perceived social support and birth weight. However, depressed women who rated their partners as less supportive had babies who were born earlier and had lower Apgar scores than depressed mothers with higher perceived partner support. Women's perception of partner support appears to buffer infants of depressed mothers from potential adverse outcomes. These results are notable in light of the low-risk nature of our sample and point to the need for continued depression screening in pregnant women and a broader view of risk for adverse birth outcomes. The results also suggest a possible means of intervention that may ultimately lead to reductions in adverse birth outcomes.

Social capital and adverse treatment outcomes of tuberculosis: a case-control study.

PubMed

Deshmukh, P R; Mundra, A; Dawale, A

2017-08-01

'Social capital' refers to social norms, relationships, networks and values that affect the functioning and development of society. Social capital influences health positively, but its role in the treatment outcomes of tuberculosis (TB) is not known. To study the role of social capital in determining adverse TB treatment outcomes. Of 516 patients registered under the Revised National Tuberculosis Control Programme in 2014 in Wardha Tuberculosis Unit, Wardha, India, we included 88 patients with adverse treatment outcomes as cases and 187 controls from among those without adverse outcomes. Multiple logistic regression was used to compare standardised Z-scores. A greater proportion of controls than cases belonged to higher quartiles of social capital and its domains than cases, and the mean standardised Z-score was also consistently higher among controls than cases. Respectively 47% and 15% of cases and controls were in the poorest quartile of social capital, whereas respectively 10% and 33% of cases and controls were in the richest quartile. Each unit increase in Z-score of overall social capital reduced the odds of adverse treatment outcomes by 63.1%. Appropriate interventions for building social capital for TB patients and linking them with the programme would improve programme performance.

Untreated maternal syphilis and adverse outcomes of pregnancy: a systematic review and meta-analysis

PubMed Central

Kamb, Mary L; Newman, Lori M; Mark, Jennifer; Broutet, Nathalie; Hawkes, Sarah J

2013-01-01

Abstract Objective To perform a systematic review and meta-analysis of reported estimates of adverse pregnancy outcomes among untreated women with syphilis and women without syphilis. Methods PubMed, EMBASE and Cochrane Libraries were searched for literature assessing adverse pregnancy outcomes among untreated women with seroreactivity for Treponema pallidum infection and non-seroreactive women. Adverse pregnancy outcomes were fetal loss or stillbirth, neonatal death, prematurity or low birth weight, clinical evidence of syphilis and infant death. Random-effects meta-analyses were used to calculate pooled estimates of adverse pregnancy outcomes and, where appropriate, heterogeneity was explored in group-specific analyses. Findings Of the 3258 citations identified, only six, all case-control studies, were included in the analysis. Pooled estimates showed that among untreated pregnant women with syphilis, fetal loss and stillbirth were 21% more frequent, neonatal deaths were 9.3% more frequent and prematurity or low birth weight were 5.8% more frequent than among women without syphilis. Of the infants of mothers with untreated syphilis, 15% had clinical evidence of congenital syphilis. The single study that estimated infant death showed a 10% higher frequency among infants of mothers with syphilis. Substantial heterogeneity was found across studies in the estimates of all adverse outcomes for both women with syphilis (66.5% [95% confidence interval, CI: 58.0–74.1]; I2 = 91.8%; P < 0.001) and women without syphilis (14.3% [95% CI: 11.8–17.2]; I2 = 95.9%; P < 0.001). Conclusion Untreated maternal syphilis is associated with adverse pregnancy outcomes. These findings can inform policy decisions on resource allocation for the detection of syphilis and its timely treatment in pregnant women. PMID:23476094

Moving healthcare quality forward with nursing-sensitive value-based purchasing.

PubMed

Kavanagh, Kevin T; Cimiotti, Jeannie P; Abusalem, Said; Coty, Mary-Beth

2012-12-01

To underscore the need for health system reform and emphasize nursing measures as a key component in our healthcare reimbursement system. 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. 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. 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. 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.

Moving Healthcare Quality Forward With Nursing-Sensitive Value-Based Purchasing

PubMed Central

Kavanagh, Kevin T; Cimiotti, Jeannie P; Abusalem, Said; Coty, Mary-Beth

2012-01-01

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. PMID:23066956

Significant Adverse Events and Outcomes After Medical Abortion

PubMed Central

Cleland, Kelly; Creinin, Mitchell D.; Nucatola, Deborah; Nshom, Montsine; Trussell, James

2013-01-01

Objective To analyze rates of significant adverse events and outcomes in women having a medical abortion at Planned Parenthood health centers in 2009 and 2010, and to identify changes in the rates of adverse events and outcomes between the 2 years. Methods In this database review we analyzed data from Planned Parenthood affiliates that provided medical abortion in 2009 and 2010, almost exclusively using an evidence-based buccal misoprostol regimen. We evaluated the incidence of six clinically significant adverse events (hospital admission, blood transfusion, emergency room treatment, intravenous antibiotics administration, infection, and death) and two significant outcomes (ongoing pregnancy and ectopic pregnancy diagnosed after medical abortion treatment was initiated). We calculated an overall rate as well as rates for each event and identified changes between the 2 years. Results Amongst 233,805 medical abortions provided in 2009 and 2010, significant adverse events or outcomes were reported in 1,530 cases (0.65%). There was no statistically significant difference in overall rates between years. The most common significant outcome was ongoing intrauterine pregnancy (0.50%); significant adverse events occurred in 0.16% of cases. One patient death occurred due to an undiagnosed ectopic pregnancy. Only rates for emergency room treatment and blood transfusion differed by year, and were slightly higher in 2010. Conclusion Review of this large dataset reinforces the safety of the evidence-based medical abortion regimen. PMID:23262942

Predicting outcome of acute non-variceal upper gastrointestinal haemorrhage without endoscopy using the clinical Rockall Score.

PubMed

Tham, T C K; James, C; Kelly, M

2006-11-01

The Rockall risk scoring system uses clinical criteria and endoscopy to identify patients at risk of adverse outcomes after acute upper gastrointestinal haemorrhage. A clinical Rockall score obtained using only the clinical criteria may be able to predict outcome without endoscopy. To validate the clinical Rockall Score in predicting outcome after acute non-variceal upper gastrointestinal haemorrhage. A retrospective observational study of consecutive patients who were admitted with non-variceal acute upper gastrointestinal haemorrhage was undertaken. Medical records were abstracted using a standardised form. 102 cases were identified (51 men and 51 women; mean age 59 years). 38 (37%) patients considered to be at low risk of adverse outcomes (clinical Rockall Score 0) had no adverse outcomes and did not require transfusion. Patients with a clinical Rockall Score of 1-3 had no adverse outcomes, although 13 of 45 (29%) patients required blood transfusions. Clinical Rockall Scores >3 (n = 19) were associated with adverse outcomes (rebleeding in 4 (21%), surgery in 1 (5%) and death in 2 (10%)). The clinical Rockall Score without endoscopy may be a useful prognostic indicator in this cohort of patients with acute non-variceal upper gastrointestinal haemorrhage. This score may reduce the need for urgent endoscopy in low-risk patients, which can instead be carried out on a more elective outpatient basis.

Integrating publicly-available data to generate computationally-predicted adverse outcome pathways for hepatic steatosis

EPA Science Inventory

The adverse outcome pathway (AOP) framework provides a way of organizing knowledge related to the key biological events that result in a particular health outcome. For the majority of environmental chemicals, the availability of curated pathways characterizing potential toxicity ...

Does Missed Care in Isolated Rural Hospitals Matter?

PubMed

Smith, Jessica G

2018-06-01

Missed care is associated with adverse outcomes such as patient falls and decreased nurse job satisfaction. Although studied in populations of interest such as neonates, children, and heart failure patients, there are no studies about missed care in rural hospitals. Reducing care omissions in rural hospitals might help improve rural patient outcomes and ensure that rural hospitals can remain open in an era of hospital reimbursement dependent on care outcomes, such as through value-based purchasing. Understanding the extent of missed nursing care and its implications for rural populations might provide crucial information to alert rural hospital administrators and nurses about the incidence and influence of missed care on health outcomes. Focusing on missed care within rural hospitals and other rural health care settings is important to address the specific health needs of aging rural U.S. residents who are isolated from high-volume, urban health care facilities.

Outcomes in transfusion.

PubMed

Sherman, L A

1999-07-01

Outcomes data in medicine can be limited by subjective methodologic issues such as poor selection of end points and use of nonvalidated systems for quality adjustment. Blood transfusion analyses are further complicated by the fact that transfusion seldom is primary therapy but is usually supportive or adjunctive. Thus, much of the outcome data in transfusion medicine are either unavailable or in one of two areas. The first area is prevention of bad sequelae of various cytopenias or factor deficiencies. The second is decreasing adverse effects of transfusion itself. A different useful area for outcome and root cause approaches in individual institutions is examining preanalytical and postanalytical processes of their own. Examples are sample labeling accuracy, quality and timeliness of blood suppliers, internal delivery processes and times, and product wastage. Use review can be changed to real time from retrospective time. By reducing complaints about service to objective data, realistic change can be made in internal and external processes.

Is the concomitant use of clopidogrel and Proton Pump Inhibitors still associated with increased adverse cardiovascular outcomes following coronary angioplasty?: a systematic review and meta-analysis of recently published studies (2012 - 2016).

PubMed

Bundhun, Pravesh Kumar; Teeluck, Abhishek Rishikesh; Bhurtu, Akash; Huang, Wei-Qiang

2017-01-05

Controversies were previously observed with the concomitant use of clopidogrel and Proton Pump Inhibitors (PPIs), especially omeprazole, following coronary angioplasty. Even though several studies showed no interaction between clopidogrel and PPIs, questions have been raised about the decrease in antiplatelet effects of clopidogrel with PPIs. A previously published meta-analysis showed concomitant use of clopidogrel and PPIs to be associated with higher adverse cardiovascular outcomes. However, data which were used were extracted from studies published before the year 2012. Whether these controversies still exist in this new era is not clear. Therefore, we aim to show if the concomitant use of clopidogrel and PPIs is still associated with higher adverse outcomes following Percutaneous Coronary Intervention (PCI) using data obtained from recently published studies (2012 to 2016). Electronic databases were searched for recent publications (2012-2016) comparing (clopidogrel plus PPIs) versus clopidogrel alone following PCI. Adverse cardiovascular outcomes were considered as the clinical endpoints. Odds Ratios (OR) with 95% Confidence Intervals (CI) were used as the statistical parameters and the pooled analyses were performed with RevMan 5.3 software. Eleven studies with a total number of 84,729 patients (29,235 patients from the PPIs group versus 55,494 patients from the non-PPIs group) were included. Results of this analysis showed that short term mortality and Target Vessel Revascularization (TVR) significantly favored the non-PPIs group with OR: 1.55; 95% CI: 1.43-1.68, P < 0.00001 and OR: 1.26; 95% CI: 1.06-1.49, P = 0.009 respectively. Long-term Major Adverse Cardiac Events (MACEs), Myocardial Infarction (MI), Stent Thrombosis (ST) and TVR significantly favored patients who did not use PPIs with OR: 1.37; 95% CI: 1.23-1.53, P < 0.00001, OR: 1.41; 95% CI: 1.26-1.57, P < 0.00001 and OR: 1.38; 95% CI: 1.13-1.70, P = 0.002 and OR: 1.28; 95% CI: 1.01-1.61, P = 0.04 respectively. However, the result for long term mortality was not statistically significant. The combined use of clopidogrel with PPIs is still associated with significantly higher adverse cardiovascular events such as MACEs, ST and MI following PCI supporting results of the previously published meta-analysis. However, long-term mortality is not statistically significant warranting further analysis with randomized patients.

Hyponatremia Predicts Poor Outcomes in Patients with Chronic Kidney Disease Undergoing Heart Surgery.

PubMed

Shavit, Linda; Merin, Ofer; Grenader, Tal; Jacobson, Ehud; Waldenberg, Chani; Bitran, Daniel; Fink, Daniel; Silberman, Shuli

2018-05-08

Preoperative hyponatremia adversely impacts outcomes of cardiothoracic surgery. However, in patients with chronic kidney disease, the association of sodium levels on postoperative events has never been evaluated. We investigated the impact of preoperative hyponatremia on outcomes after cardiac surgery in patients with non-dialysis-dependent chronic kidney disease. Primary endpoints were operative mortality and acute kidney injury requiring dialysis. Secondary endpoints were major infection and long-term survival. The study is observational and includes all patients with stage III-IV chronic kidney disease (non-dialysis) undergoing cardiac surgery between February 2000-January 2016. Patients were stratified into 2 groups by preoperative sodium levels: Na <135 mEq/L; Na ≥135 mEq/L. There were 1008 patients (mean eGFR 43 ± 14 mL/min/1.73 m 2 ): 92 (9%) in the low sodium group. Patients with low sodium had higher operative mortality (p=0.0004), need for new dialysis (p=0.0008), and infection (p=0.002). Predictors of operative mortality were: EuroSCORE (HR1.03; CI 1.02-1.05 ; p<0.0001); Decreasing values of sodium (HR 1.14; CI 1.07-1.2; p=0.0002); and decreasing values of GFR (HR1.01; CI 1.003-1.03; p=0.007). Sodium below 135 mEq/L was independently associated with increased need for dialysis (HR1.3; CI 1.1-1.7; p= 0.0008). By linear regression, decreasing values of preoperative sodium were proportionate to the incidence of operative mortality (p<0.0001) and need for dialysis (p<0.0001). Preoperative hyponatremia is a predictor of increased mortality as well as other adverse events in patients with non- dialysis dependent chronic kidney disease undergoing cardiac surgery. These findings are similar to those in hyponatremic patients without kidney disease. Copyright © 2018. Published by Elsevier Inc.

Poor mental health among low-income women in the U.S.: The roles of adverse childhood and adult experiences.

PubMed

Mersky, Joshua P; Janczewski, Colleen E; Nitkowski, Jenna C

2018-06-01

It is well established that exposure to a greater number of adverse childhood experiences (ACEs) increases the risk of poor physical and mental health outcomes. Given the predictive validity of ACE scores and other cumulative risk metrics, a similar measurement approach may advance the study of risk in adulthood. We examined the prevalence and interrelations of 10 adverse adult experiences, including household events such as intimate partner violence and extrafamilial events such as crime victimization. We also tested the relation between cumulative adult adversity and later mental health problems, and we examined whether adult adversity mediates the link between childhood adversity and mental health. Data were collected from 501 women in the Families and Children Thriving Study, a longitudinal investigation of low-income families that received home visiting services in Wisconsin. We conducted correlation analyses to assess interrelations among study measures along with multivariate analyses to test the effects of childhood and adult adversity on three outcomes: depression, anxiety, and posttraumatic stress disorder (PTSD). We then fit a structural equation model to test whether the effects of childhood adversity on mental health are mediated by adult adversity. Over 80% of participants endorsed at least one adverse adult experience. Adult adversities correlated with each other and with the mental health outcomes. Controlling for ACEs and model covariates, adult adversity scores were positively associated with depression, anxiety, and PTSD scores. Path analyses revealed that the ACE-mental health connection was mediated by adult adversity. Our findings indicate that mental health problems may be better understood by accounting for processes through which early adversity leads to later adversity. Pending replication, this line of research has the potential to improve the identification of populations that are at risk of poor health outcomes. Copyright © 2018 Elsevier Ltd. All rights reserved.

Using interactive voice response to improve disease management and compliance with acute coronary syndrome best practice guidelines: A randomized controlled trial.

PubMed

Sherrard, Heather; Duchesne, Lloyd; Wells, George; Kearns, Sharon Ann; Struthers, Christine

2015-01-01

There is evidence from large clinical trials that compliance with standardized best practice guidelines (BPGs) improves survival of acute coronary syndrome (ACS) patients. However, their application is often suboptimal. In this study, the researchers evaluated whether the use of an interactive voice response (IVR) follow-up system improved ACS BPG compliance. This was a single-centre randomized control trial (RCT) of 1,608 patients (IVR=803; usual care=805). The IVR group received five automated calls in 12 months. The primary composite outcome was increased medication compliance and decreased adverse events. A significant improvement of 60% in the IVR group for the primary composite outcome was found (RR 1.60, 95% CI: 1.29 to 2.00, p <0.001). There was significant improvement in medication compliance (p <0.001) and decrease in unplanned medical visits (p = 0.023). At one year, the majority of patients ( 85%) responded positively to using the system again. Follow-up by IVR produced positive outcomes in ACS patients.

An examination of periodontal treatment, dental care, and pregnancy outcomes in an insured population in the United States.

PubMed

Albert, David A; Begg, Melissa D; Andrews, Howard F; Williams, Sharifa Z; Ward, Angela; Conicella, Mary Lee; Rauh, Virginia; Thomson, Janet L; Papapanou, Panos N

2011-01-01

We examined whether periodontal treatment or other dental care is associated with adverse birth outcomes within a medical and dental insurance database. In a retrospective cohort study, we examined the records of 23,441 women enrolled in a national insurance plan who delivered live births from singleton pregnancies in the United States between January 1, 2003, and September 30, 2006, for adverse birth outcomes on the basis of dental treatment received. We compared rates of low birthweight and preterm birth among 5 groups, specifying the relative timing and type of dental treatment received. We used logistic regression analysis to compare outcome rates across treatment groups while adjusting for duration of continuous dental coverage, maternal age, pregnancy complications, neighborhood-level income, and race/ethnicity. Analyses showed that women who received preventive dental care had better birth outcomes than did those who received no treatment (P < .001). We observed no evidence of increased odds of adverse birth outcomes from dental or periodontal treatment. For women with medical and dental insurance, preventive care is associated with a lower incidence of adverse birth outcomes.

Ameliorating the biological impacts of childhood adversity: A review of intervention programs.

PubMed

Purewal Boparai, Sukhdip K; Au, Vanessa; Koita, Kadiatou; Oh, Debora Lee; Briner, Susan; Burke Harris, Nadine; Bucci, Monica

2018-05-01

Childhood adversity negatively impacts the biological development of children and has been linked to poor health outcomes across the life course. The purpose of this literature review is to explore and evaluate the effectiveness of interventions that have addressed an array of biological markers and physical health outcomes in children and adolescents affected by adversity. PubMed, CINAHL, PsychInfo, Sociological Abstracts databases and additional sources (Cochrane, WHO, NIH trial registries) were searched for English language studies published between January 2007 and September 2017. Articles with a childhood adversity exposure, biological health outcome, and evaluation of intervention using a randomized controlled trial study design were selected. The resulting 40 intervention studies addressed cortisol outcomes (n = 20) and a range of neurological, epigenetic, immune, and other outcomes (n = 22). Across institutional, foster care, and community settings, intervention programs demonstrated success overall for improving or normalizing morning and diurnal cortisol levels, and ameliorating the impacts of adversity on brain development, epigenetic regulation, and additional outcomes in children. Factors such as earlier timing of intervention, high quality and nurturant parenting traits, and greater intervention engagement played a role in intervention success. This study underlines progress and promise in addressing the health impacts of adversity in children. Ongoing research efforts should collect baseline data, improve retention, replicate studies in additional samples and settings, and evaluate additional variables, resilience factors, mediators, and long-term implications of results. Clinicians should integrate lessons from the intervention sciences for preventing and treating the health effects of adversity in children and adolescents. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Comparison of bupivacaine and ropivacaine in combination with fentanyl used for walking epidural anesthesia in labor

PubMed Central

Gündüz, Şükrü; Eriş Yalçın, Serenat; Karakoç, Gökhan; Akkurt, Mehmet Özgür; Yalçın, Yakup; Yavuz, And

2017-01-01

Objective: Effective pain relief during labor is essential to reduce maternal and perinatal morbidity arising due to pain-induced maternal sympathetic activation, and to avoid unnecessary cesarean sections performed due to maternal anxiety. Walking epidural analgesia on labor reveals lower pain scores, leading to higher maternal satisfaction with better cardiovascular and pulmonary physiology. Despite the extensive use and relative safety of bupivacaine, newer drugs such as ropivacaine have been developed as alternative agents to decrease the risk for cardiac and central nervous system toxicity. Materials and Methods: One hundred women who requested epidural analgesia in active labor were randomly allocated into two groups; one group received 20 mL of ropivacaine 0.125% with fentanyl 50 µg and the other received 20 mL of bupivacaine 0.125% with fentanyl 50 µg. The efficacy of analgesia, adverse effects, and obstetric and neonatal outcomes of both groups were compared. Results: There were no differences between the two study groups in the measured obstetric and neonatal outcomes. The onset time, duration of analgesia, and sensory levels were similar between the groups. Visual analog pain scale scores did not differ between the groups before analgesia or at any of the subsequent evaluation periods. Conclusion: Both ropivacaine and bupivacaine provide equivalent labor analgesia with high maternal satisfaction and tolerable adverse effects in the clinically used dose range. No adverse obstetric or neonatal outcomes were observed in either group. Therefore, either drug is a reasonable choice for labor analgesia and can be used without jeopardizing the safety of the mother and fetus. PMID:29085707

Maternal Smoking Among Women With and Without Use of Assisted Reproductive Technologies

PubMed Central

Tong, Van T.; Kissin, Dmitry M.; Bernson, Dana; Copeland, Glenn; Boulet, Sheree L.; Zhang, Yujia; Jamieson, Denise J.; England, Lucinda J.

2016-01-01

Objective To estimate smoking prevalence during the year before pregnancy and during pregnancy and adverse outcomes among women who delivered infants with and without assisted reproductive technology (ART) using linked birth certificates (BC) and National ART Surveillance System (NASS) data. Methods Data were analyzed for 384,390 women and 392,248 infants born in Massachusetts and Michigan during 2008–2009. Maternal smoking prevalence was estimated using smoking indicated from BC by ART status. For ART users, to evaluate underreporting, prepregnancy smoking was estimated from BC, NASS, or both sources. Effect of prenatal smoking on preterm and mean birthweight (term only) for singleton infants were examined by ART status. Results Maternal smoking prevalence estimates were significantly lower for ART users than nonusers (pre-pregnancy = 3.2% vs. 16.7%; prenatal = 1.0% vs. 11.1%, p < 0.05). When combining smoking information from BC and NASS, prepregnancy smoking prevalence estimates for ART users could be as high as 4.4% to 6.1%. Adverse effects of smoking on infant outcomes in ART pregnancies were consistent with the effects seen in non-ART pregnancies, specifically decline in infant birthweight and increase in preterm delivery, although association between smoking and preterm was not significant. Conclusion A low, but substantial proportion of ART users smoked before and during pregnancy. As ART users are highly motivated to get pregnant, it should be clearly communicated that smoking can decrease fertility and adversely affect pregnancy outcomes. Continued efforts are needed to encourage smoking cessation and maintain tobacco abstinence among all women of reproductive age. PMID:27243366

Bariatric surgery and vitamin D: key messages for surgeons and clinicians before and after bariatric surgery.

PubMed

Peterson, Leigh A

2016-10-01

Obesity is the most widespread nutritional problem globally. Bariatric surgery is the preeminent long-term obesity treatment. Bariatric procedures manipulate the intestines to produces malabsorption and/or restrict the size of the stomach. The most enduring bariatric procedure is the Roux-en-Y gastric bypass, which utilizes both restriction (small stomach pouch) and malabsorption (duodenum bypass). The in-vogue procedure is the vertical sleeve gastrectomy - resection of the greater curvature of the stomach (predominantly restrictive). Malabsorptive procedures function by decreasing nutrient absorption, primarily fat and fat-soluble nutrients (vitamins A, D, E, and K). Most studies of vitamin D status in bariatric surgery candidates reported a prevalence of over 50% vitamin D deficiency (<50 nmol/L), enduring post-operatively with one study reporting 65% deficient at 10 years post-bariatric surgery. Obesity is associated with chronic inflammation, which may contribute to adverse surgical outcomes, e.g. poor healing and infection. Since vitamin D deficiency is also associated with chronic inflammation, obese individuals with vitamin D deficiency have extraordinary risk of adverse surgical outcomes, particularly delayed wound healing and infection due to the role of vitamin D in re-epithelialization and innate immunity. When the risk of adverse surgical outcomes in obesity is combined with that of vitamin D deficiency, there is likely an additive or potentially a synergistic effect. Furthermore, deficiency in fat-soluble vitamins, such as vitamin D, is considered a metabolic complication of bariatric surgery. Thus, determining the vitamin D status of bariatric surgery candidates and amending it preoperatively may prove greatly beneficial acutely and lifelong.

Adverse Outcome Pathways for Embryonic Vascular Disruption and Alternative Methods to Identify Chemical Vascular Disruptor

EPA Science Inventory

Chemically induced vascular toxicity during embryonic development can result in a wide range of adverse prenatal outcomes. We used information from genetic mouse models linked to phenotypic outcomes and a vascular toxicity knowledge base to construct an embryonic vascular disrupt...

Theoretical Framework to Extend Adverse Outcome Pathways to Include Pharmacokinetic Considerations

EPA Science Inventory

Adverse Outcome Pathways (AOPs) have generated intense interest for their utility in linking known population outcomes to a molecular initiating event (MIE) that can be quantified using in vitro methods. While there are tens of thousands of chemicals in commercial use, biology h...

Trihalomethanes in public drinking water and stillbirth and low birth weight rates: an intervention study.

PubMed

Iszatt, Nina; Nieuwenhuijsen, Mark J; Bennett, James E; Toledano, Mireille B

2014-12-01

During 2003-2004, United Utilities water company in North West England introduced enhanced coagulation (EC) to four treatment works to mitigate disinfection by-product (DBP) formation. This enabled examination of the relation between DBPs and birth outcomes whilst reducing socioeconomic confounding. We compared stillbirth, and low and very low birth weight rates three years before (2000-2002) with three years after (2005-2007) the intervention, and in relation to categories of THM change. We created exposure metrics for EC and trihalomethane (THM) concentration change (n=258 water zones). We linked 429,599 live births and 2279 stillbirths from national birth registers to the water zone at birth. We used Poisson regression to model the differences in birth outcome rates with an interaction between before/after the intervention and EC or THM change. EC treatment reduced chloroform concentrations more than non-treatment (mean -29.7 µg/l vs. -14.5 µg/l), but not brominated THM concentrations. Only 6% of EC water zones received 100% EC water, creating exposure misclassification concerns. EC intervention was not associated with a statistically significant reduction in birth outcome rates. Areas with the highest chloroform decrease (30 - 65 μg/l) had the greatest percentage decrease in low -9 % (-12, -5) and very low birth weight -16% (-24, -8) rates. The interaction between before/after intervention and chloroform change was statistically significant only for very low birth weight, p=0.02. There were no significant decreases in stillbirth rates. In a novel approach for studying DBPs and adverse reproductive outcomes, the EC intervention to reduce DBPs did not affect birth outcome rates. However, a measured large decrease in chloroform concentrations was associated with statistically significant reductions in very low birth weight rates. Copyright © 2014 Elsevier Ltd. All rights reserved.

Developing and applying the adverse outcome pathway ...

EPA Pesticide Factsheets

To support a paradigm shift in regulatory toxicology testing and risk assessment, the Adverse Outcome Pathway (AOP) concept has recently been proposed. This concept is similar to that for Mode of Action (MOA), describing a sequence of measurable key events triggered by a molecular initiating event in which a stressor interacts with a biological target. The resulting cascade of key events includes molecular, cellular, structural and functional changes in biological systems, resulting in a measurable adverse outcome. Thereby, an AOP ideally provides information relevant to chemical structure-activity relationships as a basis to predict effects for structurally similar compounds. AOPs could potentially also form the basis for qualitative and quantitative predictive modeling of the human adverse outcome resulting from molecular initiating or other key events for which higher-throughput testing methods are available or can be developed.A variety of cellular and molecular processes are known to be critical to normal function of the central (CNS) and peripheral nervous systems (PNS). Because of the biological and functional complexity of the CNS and PNS, it has been challenging to establish causative links and quantitative relationships between key events that comprise the pathways leading from chemical exposure to an adverse outcome in the nervous system. Following introduction of principles of the description and assessment of MOA and AOPs, examples of adverse out

Lest we forget: comparing retrospective and prospective assessments of adverse childhood experiences in the prediction of adult health.

PubMed

Reuben, Aaron; Moffitt, Terrie E; Caspi, Avshalom; Belsky, Daniel W; Harrington, Honalee; Schroeder, Felix; Hogan, Sean; Ramrakha, Sandhya; Poulton, Richie; Danese, Andrea

2016-10-01

Adverse childhood experiences (ACEs; e.g. abuse, neglect, and parental loss) have been associated with increased risk for later-life disease and dysfunction using adults' retrospective self-reports of ACEs. Research should test whether associations between ACEs and health outcomes are the same for prospective and retrospective ACE measures. We estimated agreement between ACEs prospectively recorded throughout childhood (by Study staff at Study member ages 3, 5, 7, 9, 11, 13, and 15) and retrospectively recalled in adulthood (by Study members when they reached age 38), in the population-representative Dunedin cohort (N = 1,037). We related both retrospective and prospective ACE measures to physical, mental, cognitive, and social health at midlife measured through both objective (e.g. biomarkers and neuropsychological tests) and subjective (e.g. self-reported) means. Dunedin and U.S. Centers for Disease Control ACE distributions were similar. Retrospective and prospective measures of adversity showed moderate agreement (r = .47, p < .001; weighted Kappa = .31, 95% CI: .27-.35). Both associated with all midlife outcomes. As compared to prospective ACEs, retrospective ACEs showed stronger associations with life outcomes that were subjectively assessed, and weaker associations with life outcomes that were objectively assessed. Recalled ACEs and poor subjective outcomes were correlated regardless of whether prospectively recorded ACEs were evident. Individuals who recalled more ACEs than had been prospectively recorded were more neurotic than average, and individuals who recalled fewer ACEs than recorded were more agreeable. Prospective ACE records confirm associations between childhood adversity and negative life outcomes found previously using retrospective ACE reports. However, more agreeable and neurotic dispositions may, respectively, bias retrospective ACE measures toward underestimating the impact of adversity on objectively measured life outcomes and overestimating the impact of adversity on self-reported outcomes. Associations between personality factors and the propensity to recall adversity were extremely modest and warrant further investigation. Risk predictions based on retrospective ACE reports should utilize objective outcome measures. Where objective outcome measurements are difficult to obtain, correction factors may be warranted. © 2016 Association for Child and Adolescent Mental Health.

Lest we forget: Comparing retrospective and prospective assessments of adverse childhood experiences in the prediction of adult health

PubMed Central

Reuben, Aaron; Moffitt, Terrie E.; Caspi, Avshalom; Belsky, Daniel W.; Harrington, Honalee; Schroeder, Felix; Hogan, Sean; Ramrakha, Sandhya; Poulton, Richie; Danese, Andrea

2017-01-01

Background Adverse childhood experiences (ACEs; e.g., abuse, neglect, parental loss, etc.) have been associated with increased risk for later-life disease and dysfunction using adults’ retrospective self-reports of ACEs. Research should test whether associations between ACEs and health outcomes are the same for prospective and retrospective ACE measures. Methods We estimated agreement between ACEs prospectively-recorded throughout childhood (by Study staff at Study member ages 3, 5, 7, 9, 11, 13, and 15) and retrospectively-recalled in adulthood (by Study members when they reached age 38), in the population-representative Dunedin cohort (N=1,037). We related both retrospective and prospective ACE measures to physical, mental, cognitive, and social health at midlife measured through both objective (e.g., biomarkers and neuropsychological tests) and subjective (e.g., self-reported) means. Results Dunedin and CDC ACE distributions were similar. Retrospective and prospective measures of adversity showed moderate agreement (r=.47, p<.001; weighted Kappa = .31, 95% CI: .27–.35). Both associated with all midlife outcomes. As compared to prospective ACEs, retrospective ACEs showed stronger associations with life outcomes that were subjectively assessed, and weaker associations with life outcomes that were objectively assessed. Recalled ACEs and poor subjective outcomes were correlated regardless of whether prospectively-recorded ACEs were evident. Individuals who recalled more ACEs than had been prospectively recorded were more neurotic than average, and individuals who recalled fewer ACEs than recorded were more agreeable. Conclusions Prospective ACE records confirm associations between childhood adversity and negative life outcomes found previously using retrospective ACE reports. However, more agreeable and neurotic dispositions may respectively bias retrospective ACE measures toward underestimating the impact of adversity on objectively-measured life outcomes and overestimating the impact of adversity on self-reported outcomes. Associations between personality factors and the propensity to recall adversity were extremely modest and warrant further investigation. Risk predictions based on retrospective ACE reports should utilize objective outcome measures. Where objective outcome measurements are difficult to obtain, correction factors may be warranted. PMID:27647050

Interventions to prevent adverse fetal programming due to maternal obesity during pregnancy.

PubMed

Nathanielsz, Peter W; Ford, Stephen P; Long, Nathan M; Vega, Claudia C; Reyes-Castro, Luis A; Zambrano, Elena

2013-10-01

Maternal obesity is a global epidemic affecting both developed and developing countries. Human and animal studies indicate that maternal obesity adversely programs the development of offspring, predisposing them to chronic diseases later in life. Several mechanisms act together to produce these adverse health effects. There is a consequent need for effective interventions that can be used in the management of human pregnancy to prevent these outcomes. The present review analyzes the dietary and exercise intervention studies performed to date in both altricial and precocial animals, rats and sheep, with the aim of preventing adverse offspring outcomes. The results of these interventions present exciting opportunities to prevent, at least in part, adverse metabolic and other outcomes in obese mothers and their offspring. © 2013 International Life Sciences Institute.

U-shaped curve for risk associated with maternal hemoglobin, iron status, or iron supplementation.

PubMed

Dewey, Kathryn G; Oaks, Brietta M

2017-12-01

Both iron deficiency (ID) and excess can lead to impaired health status. There is substantial evidence of a U-shaped curve between the risk of adverse birth outcomes and maternal hemoglobin concentrations during pregnancy; however, it is unclear whether those relations are attributable to conditions of low and high iron status or to other mechanisms. We summarized current evidence from human studies regarding the association between birth outcomes and maternal hemoglobin concentrations or iron status. We also reviewed effects of iron supplementation on birth outcomes among women at low risk of ID and the potential mechanisms for adverse effects of high iron status during pregnancy. Overall, we confirmed a U-shaped curve for the risk of adverse birth outcomes with maternal hemoglobin concentrations, but the relations differ by trimester. For low hemoglobin concentrations, the link with adverse outcomes is more evident when hemoglobin concentrations are measured in early pregnancy. These relations generally became weaker or nonexistent when hemoglobin concentrations are measured in the second or third trimesters. Associations between high hemoglobin concentration and adverse birth outcomes are evident in all 3 trimesters but evidence is mixed. There is less evidence for the associations between maternal iron status and adverse birth outcomes. Most studies used serum ferritin (SF) concentrations as the indicator of iron status, which makes the interpretation of results challenging because SF concentrations increase in response to inflammation or infection. The effect of iron supplementation during pregnancy may depend on initial iron status. There are several mechanisms through which high iron status during pregnancy may have adverse effects on birth outcomes, including oxidative stress, increased blood viscosity, and impaired systemic response to inflammation and infection. Research is needed to understand the biological processes that underlie the U-shaped curves seen in observational studies. Reevaluation of cutoffs for hemoglobin concentrations and indicators of iron status during pregnancy is also needed. © 2017 American Society for Nutrition.

Effects of maternal serum 25-hydroxyvitamin D concentrations in the first trimester on subsequent pregnancy outcomes in an Australian population.

PubMed

Schneuer, Francisco J; Roberts, Christine L; Guilbert, Cyrille; Simpson, Judy M; Algert, Charles S; Khambalia, Amina Z; Tasevski, Vitomir; Ashton, Anthony W; Morris, Jonathan M; Nassar, Natasha

2014-02-01

Low serum 25-hydroxyvitamin D [25(OH)D] concentrations during pregnancy have been associated with adverse pregnancy outcomes in a few studies but not in other studies. We assessed the serum 25(OH)D concentration at 10-14 wk of pregnancy and its association with adverse pregnancy outcomes and examined the predictive accuracy. In this nested case-control study, we measured serum 25(OH)D in 5109 women with singleton pregnancies who were attending first-trimester screening in New South Wales, Australia. Multivariate logistic regression was conducted to examine the association between low 25(OH)D concentrations and adverse pregnancy outcomes (small for gestational age, preterm birth, preeclampsia, gestational diabetes, miscarriage, and stillbirth). The predictive accuracy of models was assessed. The median (IQR) 25(OH)D concentration for the total population was 56.4 nmol/L (43.3-69.8 nmol/L). Serum 25(OH)D concentrations showed significant variation by parity, smoking, weight, season of sampling, country of birth, and socioeconomic status. After adjustment for maternal and clinical risk factors, low 25(OH)D concentrations were not associated with most adverse pregnancy outcomes. The area under the receiver operating characteristic curve (AUC) and likelihood ratio for a composite of severe adverse pregnancy outcomes of 25(OH)D concentrations <25 nmol/L were 0.51 and 1.44, respectively, and, for risk factors alone, were 0.64 and 2.87, respectively. The addition of 25(OH)D information to maternal and clinical risk factors did not improve the ability to predict severe adverse pregnancy outcomes (AUC: 0.64; likelihood ratio: 2.32; P = 0.39). Low 25(OH)D serum concentrations in the first trimester of pregnancy are not associated with adverse pregnancy outcomes and do not predict complications any better than routinely assessed clinical and maternal risk-factor information.

Effects of an Integrative Nursing Intervention on Pain in Critically Ill Patients: A Pilot Clinical Trial.

PubMed

Papathanassoglou, Elizabeth D E; Hadjibalassi, Maria; Miltiadous, Panagiota; Lambrinou, Ekaterini; Papastavrou, Evridiki; Paikousis, Lefkios; Kyprianou, Theodoros

2018-05-01

Pain, a persistent problem in critically ill patients, adversely affects outcomes. Despite recommendations, no evidence-based nonpharmacological approaches for pain treatment in critically ill patients have been developed. To investigate the effects of a multimodal integrative intervention on the incidence of pain and on secondary outcomes: intensity of pain, hemodynamic indices (systolic and mean arterial pressure, heart rate), anxiety, fear, relaxation, optimism, and sleep quality. A randomized, controlled, double-blinded repeated-measures trial with predetermined eligibility criteria was conducted. The intervention included relaxation, guided imagery, moderate pressure massage, and listening to music. The primary outcome was incidence of pain (score on Critical Care Pain Observation Tool > 2). Other outcomes included pain ratings, hemodynamic measurements, self-reported psychological outcomes, and quality of sleep. Repeated-measures models with adjustments (baseline levels, confounders) were used. Among the 60 randomized critically ill adults in the sample, the intervention group experienced significant decreases in the incidence ( P = .003) and ratings of pain ( P < .001). Adjusted models revealed a significant trend for lower incidence ( P = .002) and ratings ( P < .001) of pain, systolic arterial pressure ( P < .001), anxiety ( P = .01), and improved quality of sleep ( P = .02). A multimodal integrative intervention may be effective in decreasing pain and improving pain-related outcomes in critically ill patients. © 2018 American Association of Critical-Care Nurses.

Association of low body temperature and poor outcomes in patients admitted with worsening heart failure: a substudy of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial.

PubMed

Payvar, Saeed; Spertus, John A; Miller, Alan B; Casscells, S Ward; Pang, Peter S; Zannad, Faiez; Swedberg, Karl; Maggioni, Aldo P; Reid, Kimberly J; Gheorghiade, Mihai

2013-12-01

Risk stratification in patients admitted with worsening heart failure (HF) is essential for tailoring therapy and counselling. Risk models are available but rarely used, in part because many require laboratory and imaging results that are not routinely available. Body temperature is associated with prognosis in other illnesses, and we hypothesized that low body temperature would be associated with worse outcomes in patients admitted with worsening HF. The Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial was an event-driven, randomized, double-blind, placebo-controlled study of tolvaptan in 4133 patients hospitalized for worsening HF with an EF <40%. Co-primary endpoints were all-cause mortality and cardiovascular (CV) death or HF rehospitalization. Body temperature was measured orally at randomization and entered in analyses both as a continuous variable and categorized into three groups (<36 °C, 36-36.5 °C, and >36.5 °C) using Cox regression models. The composite of CV death or HF rehospitalization occurred in 1544 patients within 1 year. For every 1 °C decrease in body temperature, the risk of adverse outcomes increased by 16% [hazard raio (HR) 1.16, 95% confidence interval (CI) 1.04-1.28], after adjustment for age, gender, race, systolic blood pressure, EF, blood urea nitrogen, and serum sodium. In fully adjusted analysis, the risk of adverse outcomes in the lowest body temperature group (<36 °C) was 51% higher than that of the index group (>36.5 °C) (HR 1.35, 95% CI 1.15-1.58). Low body temperature is an independent marker of poor cardiovascular outcomes in patients admitted with worsening HF and reduced EF.

Terbutaline pump maintenance therapy after threatened preterm labour for reducing adverse neonatal outcomes.

PubMed

Chawanpaiboon, Saifon; Laopaiboon, Malinee; Lumbiganon, Pisake; Sangkomkamhang, Ussanee S; Dowswell, Therese

2014-03-23

After successful inhibition of threatened preterm labour women are at high risk of recurrent preterm labour. Terbutaline pump maintenance therapy has been used to reduce adverse neonatal outcomes. This review replaces an earlier Cochrane review, published in 2002, which is no longer being updated by the team. To determine the effectiveness of terbutaline pump maintenance therapy after threatened preterm labour in reducing adverse neonatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2014) and reference lists of retrieved studies. Randomised controlled trials comparing terbutaline pump therapy with alternative therapy, placebo, or no therapy after arrest of threatened preterm labour. Two review authors independently assessed the studies for inclusion and then extracted data as eligible for inclusion in qualitative and quantitative synthesis (meta-analysis). Four studies were included with a total of 234 women randomised. The overall methodological quality of the included studies was mixed; two studies provided very little information on study methods, there was high sample attrition in one study and in three studies the risk of performance bias was high. We found no strong evidence that terbutaline maintenance therapy offered any advantages over saline placebo or oral terbutaline maintenance therapy in reducing adverse neonatal outcomes by prolonging pregnancy among women with arrested preterm labour. The mean difference (MD) for gestational age at birth was -0.14 weeks (95% confidence interval (CI) -1.66 to 1.38) for terbutaline pump therapy compared with saline placebo pump for two trials combined. One trial reported a risk ratio (RR) of 1.17 (95% CI 0.79 to 1.73) for preterm birth (less than 37 completed weeks) and a RR of 0.97 (95% CI 0.51 to 1.84) of very preterm birth (less than 34 completed weeks) for terbutaline pump compared with saline placebo pump. We found no evidence that terbutaline pump therapy was associated with statistically significant reductions in infant respiratory distress syndrome, or neonatal intensive care unit admission compared with placebo. Compared with oral terbutaline, we found no evidence that pump therapy increased the rate of therapy continuation, or reduced the rate of infant complications or maternal hospital re-admissions. One study suggested that pump therapy resulted in significantly increased weekly cost/woman, $580 versus $12.50 (P < 0.01). No data were reported on long-term infant outcomes. We found no evidence that terbutaline pump maintenance therapy decreased adverse neonatal outcomes. Taken together with the lack of evidence of benefit, its substantial expense and the lack of information on the safety of the therapy do not support its use in the management of arrested preterm labour. Future use should only be in the context of well-conducted, adequately powered randomised controlled trials.

Does early second-trimester sonography predict adverse perinatal outcomes in monochorionic diamniotic twin pregnancies?

PubMed

Allaf, M Baraa; Campbell, Winston A; Vintzileos, Anthony M; Haeri, Sina; Javadian, Pouya; Shamshirsaz, Amir A; Ogburn, Paul; Figueroa, Reinaldo; Wax, Joseph; Markenson, Glenn; Chavez, Martin R; Ravangard, Samadh F; Ruano, Rodrigo; Sangi-Haghpeykar, Haleh; Salmanian, Bahram; Meyer, Marjorie; Johnson, Jeffery; Ozhand, Ali; Davis, Sarah; Borgida, Adam; Belfort, Michael A; Shamshirsaz, Alireza A

2014-09-01

To determine whether intertwin discordant abdominal circumference, femur length, head circumference, and estimated fetal weight sonographic measurements in early second-trimester monochorionic diamniotic twins predict adverse obstetric and neonatal outcomes. We conducted a multicenter retrospective cohort study involving 9 regional perinatal centers in the United States. We examined the records of all monochorionic diamniotic twin pregnancies with two live fetuses at the 16- to 18-week sonographic examination who had serial follow-up sonography until delivery. The intertwin discordance in abdominal circumference, femur length, head circumference, and estimated fetal weight was calculated as the difference between the two fetuses, expressed as a percentage of the larger using the 16- to 18-week sonographic measurements. An adverse composite obstetric outcome was defined as the occurrence of 1 or more of the following in either fetus: intrauterine growth restriction, twin-twin transfusion syndrome, intrauterine fetal death, abnormal growth discordance (≥20% difference), and very preterm birth at or before 28 weeks. An adverse composite neonatal outcome was defined as the occurrence of 1 or more of the following: respiratory distress syndrome, any stage of intraventricular hemorrhage, 5-minute Apgar score less than 7, necrotizing enterocolitis, culture-proven early-onset sepsis, and neonatal death. Receiver operating characteristic and logistic regression-with-generalized estimating equation analyses were constructed. Among the 177 monochorionic diamniotic twin pregnancies analyzed, intertwin abdominal circumference and estimated fetal weight discordances were only predictive of adverse composite obstetric outcomes (areas under the curve, 79% and 80%, respectively). Receiver operating characteristic curves showed that intertwin discordances in abdominal circumference, femur length, head circumference, and estimated fetal weight were not acceptable predictors of twin-twin transfusion syndrome or adverse neonatal outcomes. In our cohort, only second-trimester abdominal circumference and estimated fetal weight discordances in monochorionic diamniotic twin pregnancies were predictive of adverse composite obstetric outcomes. Twin-twin transfusion syndrome and adverse neonatal outcomes were not predicted by any of the intertwin discordances measured. © 2014 by the American Institute of Ultrasound in Medicine.

Incidence and Predictors of Long-Term Adverse Outcomes in Patients with Rheumatic Mitral Stenosis in Sinus Rhythm.

PubMed

Nachom, Patsadee; Ratanasit, Nithima

2016-04-01

Rheumatic fever and rheumatic heart disease remain important health problems in developing countries. Mitral stenosis (MS) is the most common form of rheumatic heart disease. The aim of this study was to investigate incidence and echocardiographic predictors of long-term adverse outcomes in patients with rheumatic mitral stenosis in sinus rhythm. We retrospectively reviewed medical records of patients diagnosed with isolated rheumatic MS of any severity at Siriraj Hospital between 1996 and 2013. Demographic data, echocardiographic data, and long-term adverse outcomes were collected. Long-term adverse outcomes included all-cause mortality, hospitalization due to heart failure, new-onset atrial fibrillation, and/or embolic stroke during follow-up. One hundred eighty five patients (aged 41.9 ± 13.2 years, 81.1% female) were included during the median follow-up period of 12.6 years (95% CI: 11.2-14.0). MS was classified as mild, moderate, and severe in 8.6%, 2 7.6%, and 63.8% of patients, respectively. Average mitral valve score was 8.25 ± 1.5. Most patients (61.6%) underwent percutaneous balloon mitral valvulotomy. Incidence of long-term adverse outcome was 43.2% (95% CI: 36.0-50.7%) and included mortality in two patients (1.1%, 95% CI: 0.13-3.9%), hospitalization due to heart failure in 20 patients (10.8%, 95% CI: 6.7-16.2%), new-onset atrial fibrillation in 71 patients (38.4%, 95% CI: 31.3-45.8%), and embolic stroke in 14 patients (7.6%, 95% CI: 4.2-12.4%). Echocardiographic parameters associated with long-term adverse outcomes were left atrial dimension greater than 50 mm (HR 2.61, 95% CI: 1.08-6.30; p = 0.03) and left ventricular end-systolic dimension less than 28 mm (HR 3.06, 95% CI: 1.25-7.49; p = 0.01). Long-term adverse outcomes are common in patients with rheumatic MS in sinus rhythm. Long-term adverse outcomes were found to correlate with left atrial dimension and left ventricular end-systolic dimension.

Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials

PubMed Central

Holmskov, Mathilde; Storebø, Ole Jakob; Moreira-Maia, Carlos R.; Ramstad, Erica; Magnusson, Frederik Løgstrup; Krogh, Helle B.; Groth, Camilla; Gillies, Donna; Zwi, Morris; Skoog, Maria; Gluud, Christian; Simonsen, Erik

2017-01-01

Objectives To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review. Methods and findings We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were summarised as risk ratios (RR) with 95% confidence intervals (CI) using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA) was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse events. All trials were at high risk of bias. In parallel group trials, methylphenidate decreased appetite (RR 3.66, 95% CI 2.56 to 5.23) and weight (RR 3.89, 95% CI 1.43 to 10.59). In cross-over trials, methylphenidate increased abdominal pain (RR 1.61, 95% CI 1.27 to 2.04). We found no significant differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes. Conclusion Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit hyperactivity disorder. No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found. PMID:28617801

Hazards of Hospitalization: Residence Prior to Admission Predicts Outcomes

ERIC Educational Resources Information Center

Friedman, Susan M.; Mendelson, Daniel A.; Bingham, Karilee W.; McCann, Robert M.

2008-01-01

Purpose: Previous studies investigating adverse outcomes of hospitalized elders have focused on community-dwelling patients. Given the rapid growth of populations living in other settings, such as assisted living facilities, it is important to understand whether these patients are at higher risk of experiencing specific adverse outcomes during…

Tiered Approaches to Incorporate the Adverse Outcome Pathway Framework into Chemical-Specific Risk-Based Decision Making

EPA Science Inventory

The concept of Adverse Outcome Pathways (AOPs) arose as a means of addressing the challenges associated with establishing relationships between high-throughout (HT) in vitro dose response data and in vivo biological outcomes. However, AOP development has also been met with challe...

AOP-DB: A database resource for the exploration of Adverse Outcome Pathways through integrated association networks.

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework describes the progression of a toxicity pathway from molecular perturbation to population-level outcome in a series of measurable, mechanistic responses. The controlled, computer-readable vocabulary that defines an AOP has the ability t...

Adverse Outcome Pathway for Embryonic Vascular Disruption and Alternative Methods to Identify Chemical Vascular Disruptors During Development

EPA Science Inventory

Chemically induced vascular toxicity during embryonic development can result in a wide range of adverse prenatal outcomes. We used information from genetic mouse models linked to phenotypic outcomes and a vascular toxicity knowledge base to construct an embryonic vascular disrupt...

Use of Adverse Outcome Pathways for Assessing Effects of the Fungicide Propiconazole on Fish Reproduction

EPA Science Inventory

Adverse outcome pathways (AOP) are used to describe the linkage of biological events from a molecular initiating point, to individual-level-endpoints relevant to risk assessment. This study was done to assess toxicity outcomes for the conazole fungicide propiconazole based on a p...

Infant Medical Trauma in the Neonatal Intensive Care Unit (IMTN): A Proposed Concept for Science and Practice.

PubMed

DʼAgata, Amy L; Young, Erin E; Cong, Xiaomei; Grasso, Damion J; McGrath, Jacqueline M

2016-08-01

Trauma is an innately subjective experience ensuing from a deeply distressing event. Research has demonstrated that while the environment of the neonatal intensive care unit (NICU) is capable of providing extraordinary lifesaving measures following birth, the experience may be disruptive to several key aspects of early development, placing infants at risk for adverse behavioral, cognitive, and emotional outcomes. This article provides rationale for the concept of Infant Medical Trauma in the NICU (IMTN) as a means of describing this unique stress experience. A triad of cumulative early life NICU experiences (stress, parental separation, and pain) is proposed to influence an infant's swinging neurodevelopmental pendulum amid the potential outcomes of risk and resilience. Creating language that describes the infant experience brings meaning and calls caregivers and parents to action to consider strategies that may improve long-term health. Actively seeking opportunities to decrease the allostatic load of at-risk infants may support an infant's pendulum to swing toward a path of resilience, thereby moderating his or her early life adverse experience.

Cause-and-effect analysis of risk management files to assess patient care in the emergency department.

PubMed

White, Andrew A; Wright, Seth W; Blanco, Roberto; Lemonds, Brent; Sisco, Janice; Bledsoe, Sandy; Irwin, Cindy; Isenhour, Jennifer; Pichert, James W

2004-10-01

Identifying the etiologies of adverse outcomes is an important first step in improving patient safety and reducing malpractice risks. However, relatively little is known about the causes of emergency department-related adverse outcomes. The objective was to describe a method for identification of common causes of adverse outcomes in an emergency department. This methodology potentially can suggest ways to improve care and might provide a model for identification of factors associated with adverse outcomes. This was a retrospective analysis of 74 consecutive files opened by a malpractice insurer between 1995 and 2000. Each risk-management file was analyzed to identify potential causes of adverse outcomes. The main outcomes were rater-assigned codes for alleged problems with care (e.g., failures of communication or problems related to diagnosis). About 50% of cases were related to injuries or abdominal complaints. A contributing cause was found in 92% of cases, and most had more than one contributing cause. The most frequent contributing categories included failure to diagnose (45%), supervision problems (31%), communication problems (30%), patient behavior (24%), administrative problems (20%), and documentation (20%). Specific relating factors within these categories, such as lack of timely resident supervision and failure to follow policies and procedures, were identified. This project documented that an aggregate analysis of risk-management files has the potential to identify shared causes related to real or perceived adverse outcomes. Several potentially correctable systems problems were identified using this methodology. These simple, descriptive management tools may be useful in identifying issues for problem solving and can be easily learned by physicians and managers.

Hylan G-F 20 Versus Low Molecular Weight Hyaluronic Acids for Knee Osteoarthritis: A Meta-Analysis.

PubMed

Zhao, Hongmou; Liu, Hongliang; Liang, Xiaojun; Li, Yi; Wang, Junhu; Liu, Cheng

2016-10-01

Hyaluronic acid injection has been reported to decrease pain compared with baseline levels in knee joint osteoarthritis. Hylan G-F 20 is distinguished from the other products by its chemical structure and relatively higher molecular weight. Many trials have compared hylan G-F 20 and low molecular weight hyaluronic acids (LMWHAs); however, their relative efficacy and safety are still debated. The aim was to compare the effectiveness and safety of intra-articular injection of hylan G-F 20 and LMWHA in the treatment of knee joint osteoarthritis. A comprehensive search of the literature up to February 2016 was performed; multiple databases were searched with 'Synvisc' or 'hylan' or 'hyaluronan' as free word terms. The pain-related outcomes and treatment-related adverse events from intent-to-treat analyzed studies were pooled for meta-analysis; other functional outcomes were included in the qualitative analysis. Twenty trials with a total of 3034 patients and 3153 knees were included, with a pooled dropout rate of 7.2 %. The pooled pain-related outcomes at 2 to 3 months reached a statistically significant difference in favor of hylan G-F 20 (I 2  = 88 %; random effects; P = 0.02), and the significance still existed with exclusion (in order to eliminate heterogeneity) of the three studies that most favored hylan G-F 20 (I 2  = 51 %; fixed effect; P = 0.03). No significant difference was reached for other group and subgroup analyses. No significant difference was reached in comparing the patients with treatment-related adverse events (seven trials; 2025 patients; P = 0.13) or the treatment-related adverse events (six trials; 1633 patients; P = 0.14). According to the current results, limited evidence showed a superior effect favoring hylan G-F 20 over LMWHA in the period from 2 to 3 months post-injection for pain-related outcomes. There was no evidence of increased risk of treatment-related adverse events for hylan G-F 20 injections.

Pulmonary function and adverse cardiovascular outcomes: Can cardiac function explain the link?

PubMed

Burroughs Peña, Melissa S; Dunning, Allison; Schulte, Phillip J; Durheim, Michael T; Kussin, Peter; Checkley, William; Velazquez, Eric J

2016-12-01

The complex interaction between pulmonary function, cardiac function and adverse cardiovascular events has only been partially described. We sought to describe the association between pulmonary function with left heart structure and function, all-cause mortality and incident cardiovascular hospitalization. This study is a retrospective analysis of patients evaluated in a single tertiary care medical center. We used multivariable linear regression analyses to examine the relationship between FVC and FEV1 with left ventricular ejection fraction (LVEF), left ventricular internal dimension in systole and diastole (LVIDS, LVIDD) and left atrial diameter, adjusting for baseline characteristics, right ventricular function and lung hyperinflation. We also used Cox proportional hazards models to examine the relationship between FVC and FEV1 with all-cause mortality and cardiac hospitalization. A total of 1807 patients were included in this analysis with a median age of 61 years and 50% were female. Decreased FVC and FEV1 were both associated with decreased LVEF. In individuals with FVC less than 2.75 L, decreased FVC was associated with increased all-cause mortality after adjusting for left and right heart echocardiographic variables (hazard ratio [HR] 0.49, 95% CI 0.29, 0.82, respectively). Decreased FVC was associated with increased cardiac hospitalization after adjusting for left heart size (HR 0.80, 95% CI 0.67, 0.96), even in patients with normal LVEF (HR 0.75, 95% CI 0.57, 0.97). In a tertiary care center reduced pulmonary function was associated with adverse cardiovascular events, a relationship that is not fully explained by left heart remodeling or right heart dysfunction. Copyright © 2016 Elsevier Ltd. All rights reserved.

Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.

PubMed

Khanpour Ardestani, Samaneh; Karkhaneh, Mohammad; Yu, Hai Chuan; Hydrie, Muhammad Zafar Iqbal; Vohra, Sunita

2017-12-19

Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events. Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data. Of 11 816 unique references, 231 T1DM RCTs were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events. Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Physical exercise in the frail elderly: an update].

PubMed

Casas Herrero, Álvaro; Cadore, Eduardo L; Martínez Velilla, Nicolás; Izquierdo Redin, Mikel

2015-01-01

Frailty is a state of vulnerability that involves an increased risk of adverse events and disability in older adults. It is a condition with a complex etiology and pathophysiology. Skeletal muscle power decreases earlier than muscle strength with advancing age and is more strongly associated with functional capacity than muscle strength in frail elderly populations. Multicomponent exercise programs, and especially resistance exercise that includes muscle power training, are currently the most relevant interventions to slow down disability and other adverse outcomes, even in the oldest-old. Moreover, these programs are valuable interventions in other frailty domains, such as falls and cognitive decline. Physical exercise, in the frail elderly, should be prescribed with a progressive individualized plan and just like other medical treatments. Copyright © 2014 SEGG. Published by Elsevier Espana. All rights reserved.

The dark side of browning.

PubMed

Tamucci, Kirstin A; Namwanje, Maria; Fan, Lihong; Qiang, Li

2018-02-01

The induction of brown-like adipocyte development in white adipose tissue (WAT) confers numerous metabolic benefits by decreasing adiposity and increasing energy expenditure. Therefore, WAT browning has gained considerable attention for its potential to reverse obesity and its associated co-morbidities. However, this perspective has been tainted by recent studies identifying the detrimental effects of inducing WAT browning. This review aims to highlight the adverse outcomes of both overactive and underactive browning activity, the harmful side effects of browning agents, as well as the molecular brake-switch system that has been proposed to regulate this process. Developing novel strategies that both sustain the metabolic improvements of WAT browning and attenuate the related adverse side effects is therefore essential for unlocking the therapeutic potential of browning agents in the treatment of metabolic diseases.

Recent findings concerning childhood food insecurity.

PubMed

Kursmark, Meredith; Weitzman, Michael

2009-05-01

Food insecurity is a relatively new measure of household and child malnutrition. This paper reviews recent studies that have examined aspects of its etiology and adverse child health and development. Smoking by adults in children's homes has recently been found to be highly associated with childhood food insecurity. Much recent research has also examined the relationship between food insecurity and childhood obesity, and thus far, whereas suggestive, results are conflicting. Some studies have found that parenting practices and parental depression are factors that link household food insecurity with childhood obesity. Other health outcomes recently shown to be associated with food insecurity include undernutrition, decreased mental proficiency, increased developmental risk, adverse pregnancy outcomes, and poor health status. Most of the studies of food insecurity to date have come from the USA. There is, however, absolutely no reason to believe that this measure, and the negative child health outcomes associated with it, does not apply to other developed nations. Similarly, it is likely that children and families living in developing countries suffer a greater prevalence and severity of food insecurity and its negative consequences. Childhood food insecurity has numerous significant negative effects on childhood health and development, may be associated with obesity, and occurs much more often in impoverished homes with adult smokers.

Maternal and perinatal outcomes in pregnancies with multiple sclerosis: a case-control study.

PubMed

Yalcin, Serenat Eris; Yalcin, Yakup; Yavuz, And; Akkurt, Mehmet Ozgur; Sezik, Mekin

2017-05-24

To assess whether maternal multiple sclerosis (MS) is associated with adverse pregnancy outcomes by determining the clinical course of disease during pregnancy and postpartum throughout a 10-year-period in a single tertiary center. We conducted a case-control study that included pregnancies with a definitive diagnosis of MS (n=43), matched with 100 healthy pregnant women with similar characteristics. Maternal and perinatal data were retrieved from hospital files. Groups were compared with the Mann-Whitney and χ2 tests. Logistic regression models were constructed to determine independent effects. Maternal demographic and baseline laboratory data were similar across the groups. Rates of preterm delivery, fetal growth restriction, preeclampsia, gestational diabetes, stillbirth, cesarean delivery, congenital malformation, and 5-min Apgar score were comparable (P>0.05 for all). General anesthesia during cesarean delivery (96% vs. 39%, P=0.002), urinary tract infection (UTI) (12% vs. 3%, P=0.04), low 1-min Apgar score (21% vs. 9%, P=0.04), and nonbreastfeeding (33% vs. 2%, P=0.001) were more frequent in women with MS. The low 1-min Apgar score and breastfeeding rates were independent of general anesthesia and UTI in regression models. MS during pregnancy was not associated with adverse maternal and perinatal outcomes except UTI, low 1-min Apgar scores, and decreased breastfeeding rates.

Outcome after anal intrasphincteric Botox injection in children with surgically treated Hirschsprung disease.

PubMed

Han-Geurts, Ingrid J M; Hendrix, Vivian C; de Blaauw, Ivo; Wijnen, Marc H W A; van Heurn, Ernest L W

2014-11-01

A nonrelaxing internal anal sphincter is present in a relatively large proportion of children with surgically treated Hirschsprung disease (HD) and can cause obstructive gastrointestinal symptoms. The short- and long-term outcome and adverse effects of intrasphincteric botulinum toxin (Botox) injections in children with obstruction after surgically treated HD are evaluated. The outcome of children with surgically treated HD treated with intrasphincteric Botox injections for obstructive symptoms was analyzed with a retrospective chart review between 2002 and 2013 in the University Medical Centers of Maastricht and Nijmegen. A total of 33 patients were included. The median time of follow-up was 7.3 years (range 1-24). A median of 2 (range 1-5) injections were given. Initial improvement was achieved in 76%, with a median duration of 4.1 months (range 1.7-58.8). Proportion of children hospitalized for enterocolitis decreased after treatment from 19 to 7. A good long-term response was found in 49%. Two children experienced complications: transient pelvic muscle paresis with impairment of walking. In both children symptoms resolved within 4 months without treatment. Intrasphincteric Botox injections in surgically treated HD are an effective long-term therapy in approximately half of our patients with obstructive symptoms. The possibility of adverse effects should be noticed.

Prediction of outcome in asphyxiated newborns treated with hypothermia: Is a MRI scoring system described before the cooling era still useful?

PubMed

Al Amrani, Fatema; Marcovitz, Jaclyn; Sanon, Priscille-Nice; Khairy, May; Saint-Martin, Christine; Shevell, Michael; Wintermark, Pia

2018-05-01

To determine whether an MRI scoring system, which was validated in the pre-cooling era, can still predict the neurodevelopmental outcome of asphyxiated newborns treated with hypothermia at 2 years of age. We conducted a retrospective cohort study of asphyxiated newborns treated with hypothermia. An MRI scoring system, which was validated in the pre-cooling era, was used to grade the severity of brain injury on the neonatal brain MRI. Their neurodevelopment was assessed around 2 years of age; adverse outcome included cerebral palsy, global developmental delay, and/or epilepsy. One hundred and sixty-nine newborns were included. Among the 131 newborns who survived and had a brain MRI during the neonatal period, 92% were evaluated around 2 years of age or later. Of these newborns, 37% displayed brain injury, and 23% developed an adverse outcome. Asphyxiated newborns treated with hypothermia who had an adverse outcome had a significantly higher MRI score (p <0.001) compared to those without an adverse outcome. An MRI scoring system that was validated before the cooling era is still able to reliably differentiate which of the asphyxiated newborns treated with hypothermia were more prone to develop an adverse outcome around 2 years of age. Copyright © 2018 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Using clinical symptoms to predict adverse maternal and perinatal outcomes in women with preeclampsia: data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study.

PubMed

Yen, Tin-Wing; Payne, Beth; Qu, Ziguang; Hutcheon, Jennifer A; Lee, Tang; Magee, Laura A; Walters, Barry N; von Dadelszen, Peter

2011-08-01

Preeclampsia is a leading cause of maternal morbidity. The clinical challenge lies in predicting which women with preeclampsia will suffer adverse outcomes and would benefit from treatment, while minimizing potentially harmful interventions. Our aim was to determine the ability of maternal symptoms (i.e., severe nausea or vomiting, headache, visual disturbance, right upper quadrant pain or epigastric pain, abdominal pain or vaginal bleeding, and chest pain or dyspnea) to predict adverse maternal or perinatal outcomes. We used data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study, a multicentre, prospective cohort study designed to investigate the maternal risks associated with preeclampsia. Relative risks and receiver operating characteristic (ROC) curves were assessed for each preeclampsia symptom and outcome pair. Of 2023 women who underwent assessment, 52% experienced at least one preeclampsia symptom, with 5.2% and 5.3% respectively experiencing an adverse maternal or perinatal outcome. No symptom and outcome pair, in either of the maternal or perinatal groups, achieved an area under the ROC curve value > 0.7, which would be necessary to demonstrate a discriminatory predictive value. Maternal symptoms of preeclampsia are not independently valid predictors of maternal adverse outcome. Caution should be used when making clinical decisions on the basis of symptoms alone in the preeclamptic patient.

Childhood and Adolescent Adversity and Cardiometabolic Outcomes: A Scientific Statement From the American Heart Association.

PubMed

Suglia, Shakira F; Koenen, Karestan C; Boynton-Jarrett, Renée; Chan, Paul S; Clark, Cari J; Danese, Andrea; Faith, Myles S; Goldstein, Benjamin I; Hayman, Laura L; Isasi, Carmen R; Pratt, Charlotte A; Slopen, Natalie; Sumner, Jennifer A; Turer, Aslan; Turer, Christy B; Zachariah, Justin P

2018-01-30

Adverse experiences in childhood and adolescence, defined as subjectively perceived threats to the safety or security of the child's bodily integrity, family, or social structures, are known to be associated with cardiometabolic outcomes over the life course into adulthood. This American Heart Association scientific statement reviews the scientific literature on the influence of childhood adversity on cardiometabolic outcomes that constitute the greatest public health burden in the United States, including obesity, hypertension, type 2 diabetes mellitus, and cardiovascular disease. This statement also conceptually outlines pathways linking adversity to cardiometabolic health, identifies evidence gaps, and provides suggestions for future research to inform practice and policy. We note that, despite a lack of objective agreement on what subjectively qualifies as exposure to childhood adversity and a dearth of prospective studies, substantial evidence documents an association between childhood adversity and cardiometabolic outcomes across the life course. Future studies that focus on mechanisms, resiliency, and vulnerability factors would further strengthen the evidence and provide much-needed information on targets for effective interventions. Given that childhood adversities affect cardiometabolic health and multiple health domains across the life course, interventions that ameliorate these initial upstream exposures may be more appropriate than interventions remediating downstream cardiovascular disease risk factor effects later in life. © 2017 American Heart Association, Inc.

The Effects of Childhood and Adolescent Adversity on Substance Use Disorders and Poor Health in Early Adulthood

PubMed Central

Wolitzky-Taylor, Kate; Sewart, Amy; Vrshek-Schallhorn, Suzanne; Zinbarg, Richard; Mineka, Susan; Hammen, Constance; Bobova, Lyuba; Adam, Emma K.; Craske, Michelle G.

2016-01-01

Childhood and adolescent adversity have been shown to predict later mental and physical health outcomes. Understanding which aspects and developmental timings of adversity are important, and the mechanisms by which they have their impact may help guide intervention approaches. A large subset of adolescents (N = 457; Female 68.9%) from the 10-year longitudinal Youth Emotion Project was examined to better understand the associations among childhood/adolescent adversity, substance use disorder, and later health quality. Adolescent (but not childhood) adversities were associated with poorer health in late adolescence/early adulthood, adolescent adversities were associated with subsequent onset of substance use disorder, and adolescent adversities continued to be associated with poorer health in late adolescence/early adulthood after accounting for the variance explained by substance use disorder onset. These associations were observed after statistically accounting for emotional disorders and socioeconomic status. Specific domains of adversity uniquely predicted substance use disorder and poorer health outcomes. In contrast with current recent research, our findings suggest the association between childhood/adolescent adversity and poorer health outcomes in late adolescence and emerging adulthood are not entirely accounted for by substance use disorder, suggesting efforts to curtail family-based adolescent adversity may have downstream health benefits. PMID:27613006

The Effects of Childhood and Adolescent Adversity on Substance Use Disorders and Poor Health in Early Adulthood.

PubMed

Wolitzky-Taylor, Kate; Sewart, Amy; Vrshek-Schallhorn, Suzanne; Zinbarg, Richard; Mineka, Susan; Hammen, Constance; Bobova, Lyuba; Adam, Emma K; Craske, Michelle G

2017-01-01

Childhood and adolescent adversity have been shown to predict later mental and physical health outcomes. Understanding which aspects and developmental timings of adversity are important, and the mechanisms by which they have their impact may help guide intervention approaches. A large subset of adolescents (N = 457; Female 68.9 %) from the 10-year longitudinal Youth Emotion Project was examined to better understand the associations among childhood/adolescent adversity, substance use disorder, and later health quality. Adolescent (but not childhood) adversities were associated with poorer health in late adolescence/early adulthood, adolescent adversities were associated with subsequent onset of substance use disorder, and adolescent adversities continued to be associated with poorer health in late adolescence/early adulthood after accounting for the variance explained by substance use disorder onset. These associations were observed after statistically accounting for emotional disorders and socioeconomic status. Specific domains of adversity uniquely predicted substance use disorder and poorer health outcomes. In contrast with current recent research, our findings suggest the association between childhood/adolescent adversity and poorer health outcomes in late adolescence and emerging adulthood are not entirely accounted for by substance use disorder, suggesting efforts to curtail family-based adolescent adversity may have downstream health benefits.

Office-Based Anesthesia: Safety and Outcomes in Pediatric Dental Patients

PubMed Central

Spera, Allison L.; Saxen, Mark A.; Yepes, Juan F.; Jones, James E.; Sanders, Brian J.

2017-01-01

The number of children with caries requiring general anesthesia to achieve comprehensive dental care and the demand for dentist anesthesiologists to provide ambulatory anesthesia for these patients is increasing. No current published studies examine the safety and outcomes of ambulatory anesthesia performed by dentist anesthesiologists for dental procedures in pediatric patients, and there is no national requirement for reporting outcomes of these procedures. In 2010, the Society for Ambulatory Anesthesia Clinical Outcomes Registry was developed. This Web-based database allows providers of ambulatory anesthesia to track patient demographics and various outcomes of procedures. Our study is a secondary analysis of data collected in the registry over a 4-year period, 2010–2014. Of the 7041 cases reviewed, no cases resulted in serious complications, including death, anaphylaxis, aspiration, cardiovascular adverse events, or neurologic adverse events. Of the 7041 cases reviewed, 196 (3.0%) resulted in a predischarge or postdischarge adverse event. The predischarge adverse event occurring with the highest frequency was laryngospasm, occurring in 35 cases (0.50%). The postdischarge adverse event occurring with the highest frequency was nausea, reported by 99 patients (5.0%). This study provides strong clinical outcomes data to support the safety of office-based anesthesia as performed by dentist anesthesiologists in the treatment of pediatric dental patients. PMID:28858554

Office-Based Anesthesia: Safety and Outcomes in Pediatric Dental Patients.

PubMed

Spera, Allison L; Saxen, Mark A; Yepes, Juan F; Jones, James E; Sanders, Brian J

The number of children with caries requiring general anesthesia to achieve comprehensive dental care and the demand for dentist anesthesiologists to provide ambulatory anesthesia for these patients is increasing. No current published studies examine the safety and outcomes of ambulatory anesthesia performed by dentist anesthesiologists for dental procedures in pediatric patients, and there is no national requirement for reporting outcomes of these procedures. In 2010, the Society for Ambulatory Anesthesia Clinical Outcomes Registry was developed. This Web-based database allows providers of ambulatory anesthesia to track patient demographics and various outcomes of procedures. Our study is a secondary analysis of data collected in the registry over a 4-year period, 2010-2014. Of the 7041 cases reviewed, no cases resulted in serious complications, including death, anaphylaxis, aspiration, cardiovascular adverse events, or neurologic adverse events. Of the 7041 cases reviewed, 196 (3.0%) resulted in a predischarge or postdischarge adverse event. The predischarge adverse event occurring with the highest frequency was laryngospasm, occurring in 35 cases (0.50%). The postdischarge adverse event occurring with the highest frequency was nausea, reported by 99 patients (5.0%). This study provides strong clinical outcomes data to support the safety of office-based anesthesia as performed by dentist anesthesiologists in the treatment of pediatric dental patients.

The Role of Mindfulness in Reducing the Adverse Effects of Childhood Stress and Trauma

PubMed Central

Ortiz, Robin; Sibinga, Erica M.

2017-01-01

Research suggests that many children are exposed to adverse experiences in childhood. Such adverse childhood exposures may result in stress and trauma, which are associated with increased morbidity and mortality into adulthood. In general populations and trauma-exposed adults, mindfulness interventions have demonstrated reduced depression and anxiety, reduced trauma-related symptoms, enhanced coping and mood, and improved quality of life. Studies in children and youth also demonstrate that mindfulness interventions improve mental, behavioral, and physical outcomes. Taken together, this research suggests that high-quality, structured mindfulness instruction may mitigate the negative effects of stress and trauma related to adverse childhood exposures, improving short- and long-term outcomes, and potentially reducing poor health outcomes in adulthood. Future work is needed to optimize implementation of youth-based mindfulness programs and to study long-term outcomes into adulthood. PMID:28264496

Risk factors for neonatal thyroid dysfunction in pregnancies complicated by Graves' disease.

PubMed

Uenaka, Mizuki; Tanimura, Kenji; Tairaku, Shinya; Morioka, Ichiro; Ebina, Yasuhiko; Yamada, Hideto

2014-06-01

To determine the factors related to adverse pregnancy outcomes and neonatal thyroid dysfunction in pregnancies complicated by Graves' disease. Thirty-five pregnancies complicated by Graves' disease were divided into two groups: adverse pregnancy outcome (n=15) and no adverse pregnancy outcome (n=20). Adverse pregnancy outcomes included spontaneous abortion, stillbirth, premature delivery, fetal growth restriction, and pregnancy-induced hypertension. The 31 pregnancies resulting in live births were also divided into two groups: neonatal thyroid dysfunction (n=9) and normal neonatal thyroid function (n=22). Serum levels of thyroid-stimulating hormone (TSH), free thyroxine (FT4), TSH-receptor antibody (TRAb), the duration of hyperthyroidism in pregnancy, doses of antithyroid medication, and the duration of maternal antithyroid medication throughout pregnancy were compared. There were no significant differences in these factors between pregnancies with an adverse pregnancy outcome and those with no adverse pregnancy outcome. However, serum levels of FT4, TRAb, the duration of hyperthyroidism in pregnancy, the maximum daily dose of antithyroid medication, and the total dose of antithyroid medication were significantly different between pregnancies with neonatal thyroid dysfunction and those with normal neonatal thyroid function. Multivariate logistic regression analysis showed that the FT4 level in mothers was a significant factor related to the development of neonatal thyroid dysfunction (odds ratio 28.84, 95% confidence interval 1.65-503.62, p<0.05). Graves' disease activity in women of childbearing age should be well controlled prior to conception. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Risk factors for adverse outcomes in older adults with blunt chest trauma: A systematic review.

PubMed

Sawa, Jake; Green, Robert S; Thoma, Brent; Erdogan, Mete; Davis, Philip J

2017-08-11

The objective of this study was to systematically review the published literature for risk factors associated with adverse outcomes in older adults sustaining blunt chest trauma. EMBASE and MEDLINE were searched from inception until March 2017 for prognostic factors associated with adverse outcomes in older adults sustaining blunt chest trauma using a pre-specified search strategy. References were independently screened for inclusion by two reviewers. Study quality was assessed using the Quality in Prognostic Studies tool. Where appropriate, descriptive statistics were used to evaluate study characteristics and predictors of adverse outcomes. Thirteen cohort studies representing 79,313 patients satisfied our selection criteria. Overall, 26 prognostic factors were examined across studies and were reported for morbidity (8 studies), length of stay (7 studies), mortality (6 studies), and loss of independence (1 study). No studies examined patient quality of life or emergency department recidivism. Prognostic factors associated with morbidity and mortality included age, number of rib fractures, and injury severity score. Although age and rib fractures were found to be associated with adverse outcomes in more than 3 studies, meta-analysis was not performed due to heterogeneity amongst included studies in how these variables were measured. While blunt chest wall trauma in older adults is relatively common, the literature on prognostic factors for adverse outcomes in this patient population remains inadequate due to a paucity of high quality studies and lack of consistent reporting standards.

Intimate partner violence among Egyptian pregnant women: incidence, risk factors, and adverse maternal and fetal outcomes.

PubMed

Ibrahim, Z M; Sayed Ahmed, W A; El-Hamid, S A; Hagras, A M

2015-01-01

To assess incidence and risk factors of intimate partner violence (IPV) during pregnancy among a sample of women from Egypt and to evaluate its impact on maternal and fetal adverse health outcomes. After obtaining ethical approval, a total of 1,857 women aged 18 - 43 years completed the study and were investigated using an interview questionnaire. The questionnaire contains five main items: demographic characteristics of women, intimate partner characteristics, assessment of IPV during current pregnancy, and assessment of maternal as well as fetal/neonatal adverse outcomes. Women were also examined to detect signs of violence and identify injuries. Exposure to IPV during pregnancy was reported among 44.1% of the studied women. Emotional violence was the most common form. Women exposed to violence were of younger age, higher parity, and lower educational level. Their partners were older, less educated, and more likely to be addicted to drugs and alcohol. Women were also found to have significantly higher incidence of adverse pregnancy outcomes (miscarriage, preterm labor, and premature rupture of membrane), and fetal/neonatal adverse outcomes (fetal distress, fetal death, and low birth weight). A total of 297 cases had been exposed to physical violence (15.9%) vs 32.6% and 10% exposed to emotional and sexual violence, respectively. The most common form of physical violence was kicking. Violence during pregnancy is prevalent among Egyptian women. Exposure to violence was a significant risk factor for multiple adverse maternal and fetal health outcomes.

Early neurodevelopmental outcomes of extremely preterm infants.

PubMed

Rogers, Elizabeth E; Hintz, Susan R

2016-12-01

Infants born at extreme preterm gestation are at risk for both death and disability. Although rates of survival have improved for this population, and some evidence suggests a trend toward decreased neuromotor impairment over the past decades, a significant improvement in overall early neurodevelopmental outcome has not yet been realized. This review will examine the rates and types of neurodevelopmental impairment seen after extremely preterm birth, including neurosensory, motor, cognitive, and behavioral outcomes. We focus on early outcomes in the first 18-36 months of life, as the majority of large neonatal studies examining neurodevelopmental outcomes stop at this age. However, this early age is clearly just a first glimpse into lifetime outcomes; the neurodevelopmental effects of extreme prematurity may last through school age, adolescence, and beyond. Importantly, prematurity appears to be an independent risk factor for adverse development, but this population demonstrates considerable variability in the types and severity of impairments. Understanding both the nature and prevalence of neurodevelopmental impairment among extremely preterm infants is important because it can lead to targeted interventions that in turn may lead to improved outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Derivation of occupational exposure levels (OELs) of low-toxicity isometric biopersistent particles: How can the kinetic lung overload paradigm be used for improved inhalation toxicity study design and OEL-derivation?

PubMed

Pauluhn, Jürgen

2014-12-20

Convincing evidence suggests that poorly soluble low-toxicity particles (PSP) exert two unifying major modes of action (MoA), in which one appears to be deposition-related acute, whilst the other is retention-related and occurs with particle accumulation in the lung and associated persistent inflammation. Either MoA has its study- and cumulative dose-specific adverse outcome and metric. Modeling procedures were applied to better understand as to which extent protocol variables may predetermine any specific outcome of study. The results from modeled and empirical studies served as basis to derive OELs from modeled and empirically confirmed directions. This analysis demonstrates that the accumulated retained particle displacement volume was the most prominent unifying denominator linking the pulmonary retained volumetric particle dose to inflammogenicity and toxicity. However, conventional study design may not always be appropriate to unequivocally discriminate the surface thermodynamics-related acute adversity from the cumulative retention volume-related chronic adversity. Thus, in the absence of kinetically designed studies, it may become increasingly challenging to differentiate substance-specific deposition-related acute effects from the more chronic retained cumulative dose-related effects. It is concluded that the degree of dissolution of particles in the pulmonary environment seems to be generally underestimated with the possibility to attribute to toxicity due to decreased particle size and associated changes in thermodynamics and kinetics of dissolution. Accordingly, acute deposition-related outcomes become an important secondary variable within the pulmonary microenvironment. In turn, lung-overload related chronic adversities seem to be better described by the particle volume metric. This analysis supports the concept that 'self-validating', hypothesis-based computational study design delivers the highest level of unifying information required for the risk characterization of PSP. In demonstrating that the PSP under consideration is truly following the generic PSP-paradigm, this higher level of mechanistic information reduces the potential uncertainty involved with OEL derivation.

Early postnatal exposure to ultrafine particulate matter air pollution: persistent ventriculomegaly, neurochemical disruption, and glial activation preferentially in male mice.

PubMed

Allen, Joshua L; Liu, Xiufang; Pelkowski, Sean; Palmer, Brian; Conrad, Katherine; Oberdörster, Günter; Weston, Douglas; Mayer-Pröschel, Margot; Cory-Slechta, Deborah A

2014-09-01

Air pollution has been associated with adverse neurological and behavioral health effects in children and adults. Recent studies link air pollutant exposure to adverse neurodevelopmental outcomes, including increased risk for autism, cognitive decline, ischemic stroke, schizophrenia, and depression. We sought to investigate the mechanism(s) by which exposure to ultrafine concentrated ambient particles (CAPs) adversely influences central nervous system (CNS) development. We exposed C57BL6/J mice to ultrafine (< 100 nm) CAPs using the Harvard University Concentrated Ambient Particle System or to filtered air on postnatal days (PNDs) 4-7 and 10-13, and the animals were euthanized either 24 hr or 40 days after cessation of exposure. Another group of males was exposed at PND270, and lateral ventricle area, glial activation, CNS cytokines, and monoamine and amino acid neurotransmitters were quantified. We observed ventriculomegaly (i.e., lateral ventricle dilation) preferentially in male mice exposed to CAPs, and it persisted through young adulthood. In addition, CAPs-exposed males generally showed decreases in developmentally important CNS cytokines, whereas in CAPs-exposed females, we observed a neuroinflammatory response as indicated by increases in CNS cytokines. We also saw changes in CNS neurotransmitters and glial activation across multiple brain regions in a sex-dependent manner and increased hippocampal glutamate in CAPs-exposed males. We observed brain region- and sex-dependent alterations in cytokines and neurotransmitters in both male and female CAPs-exposed mice. Lateral ventricle dilation (i.e., ventriculomegaly) was observed only in CAPs-exposed male mice. Ventriculomegaly is a neuropathology that has been associated with poor neurodevelopmental outcome, autism, and schizophrenia. Our findings suggest alteration of developmentally important neurochemicals and lateral ventricle dilation may be mechanistically related to observations linking ambient air pollutant exposure and adverse neurological/neurodevelopmental outcomes in humans.

Change in Adverse Events After Enrollment in the National Surgical Quality Improvement Program: A Systematic Review and Meta-Analysis.

PubMed

Montroy, Joshua; Breau, Rodney H; Cnossen, Sonya; Witiuk, Kelsey; Binette, Andrew; Ferrier, Taylor; Lavallée, Luke T; Fergusson, Dean A; Schramm, David

2016-01-01

The American College of Surgeons' National Surgical Quality Improvement Program (NSQIP) is the first nationally validated, risk-adjusted, outcomes-based program to measure and compare the quality of surgical care across North America. Participation in this program may provide an opportunity to reduce the incidence of adverse events related to surgery. A systematic review of the literature was performed. MedLine, EMBASE and PubMed were searched for studies relevant to NSQIP. Patient characteristics, intervention, and primary outcome measures were abstracted. The intervention was participation in NSQIP and monitoring of Individual Site Summary Reports with or without implementation of a quality improvement program. The outcomes of interest were change in peri-operative adverse events and mortality represented by pooled risk ratios (pRR) and 95% confidence intervals (CI). Eleven articles reporting on 35 health care institutions were included. Nine (82%) of the eleven studies implemented a quality improvement program. Minimal improvements in superficial (pRR 0.81; 95% CI 0.72-0.91), deep (pRR 0.82; 95% CI0.64-1.05) and organ space (pRR 1.15; 95% CI 0.96-1.37) infections were observed at centers that did not institute a quality improvement program. However, centers that reported formal interventions for the prevention and treatment of infections observed substantial improvements (superficial pRR 0.55, 95% CI 0.39-0.77; deep pRR 0.61, 95% CI 0.50-0.75, and organ space pRR 0.60, 95% CI 0.50-0.71). Studies evaluating other adverse events noted decreased incidence following NSQIP participation and implementation of a formal quality improvement program. These data suggest that NSQIP is effective in reducing surgical morbidity. Improvement in surgical quality appears to be more marked at centers that implemented a formal quality improvement program directed at the reduction of specific morbidities.

Change in Adverse Events After Enrollment in the National Surgical Quality Improvement Program: A Systematic Review and Meta-Analysis

PubMed Central

Montroy, Joshua; Breau, Rodney H.; Cnossen, Sonya; Witiuk, Kelsey; Binette, Andrew; Ferrier, Taylor; Lavallée, Luke T.; Fergusson, Dean A.; Schramm, David

2016-01-01

Background The American College of Surgeons’ National Surgical Quality Improvement Program (NSQIP) is the first nationally validated, risk-adjusted, outcomes-based program to measure and compare the quality of surgical care across North America. Participation in this program may provide an opportunity to reduce the incidence of adverse events related to surgery. Study Design A systematic review of the literature was performed. MedLine, EMBASE and PubMed were searched for studies relevant to NSQIP. Patient characteristics, intervention, and primary outcome measures were abstracted. The intervention was participation in NSQIP and monitoring of Individual Site Summary Reports with or without implementation of a quality improvement program. The outcomes of interest were change in peri-operative adverse events and mortality represented by pooled risk ratios (pRR) and 95% confidence intervals (CI). Results Eleven articles reporting on 35 health care institutions were included. Nine (82%) of the eleven studies implemented a quality improvement program. Minimal improvements in superficial (pRR 0.81; 95% CI 0.72–0.91), deep (pRR 0.82; 95% CI0.64–1.05) and organ space (pRR 1.15; 95% CI 0.96–1.37) infections were observed at centers that did not institute a quality improvement program. However, centers that reported formal interventions for the prevention and treatment of infections observed substantial improvements (superficial pRR 0.55, 95% CI 0.39–0.77; deep pRR 0.61, 95% CI 0.50–0.75, and organ space pRR 0.60, 95% CI 0.50–0.71). Studies evaluating other adverse events noted decreased incidence following NSQIP participation and implementation of a formal quality improvement program. Conclusions These data suggest that NSQIP is effective in reducing surgical morbidity. Improvement in surgical quality appears to be more marked at centers that implemented a formal quality improvement program directed at the reduction of specific morbidities. PMID:26812596

Ventral striatal activity links adversity and reward processing in children.

PubMed

Kamkar, Niki H; Lewis, Daniel J; van den Bos, Wouter; Morton, J Bruce

2017-08-01

Adversity impacts many aspects of psychological and physical development including reward-based learning and decision-making. Mechanisms relating adversity and reward processing in children, however, remain unclear. Here, we show that adversity is associated with potentiated learning from positive outcomes and impulsive decision-making, but unrelated to learning from negative outcomes. We then show via functional magnetic resonance imaging that the link between adversity and reward processing is partially mediated by differences in ventral striatal response to rewards. The findings suggest that early-life adversity is associated with alterations in the brain's sensitivity to rewards accounting, in part, for the link between adversity and altered reward processing in children. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Racial and ethnic variations in phthalate metabolite concentration changes across full-term pregnancies.

PubMed

James-Todd, Tamarra M; Meeker, John D; Huang, Tianyi; Hauser, Russ; Seely, Ellen W; Ferguson, Kelly K; Rich-Edwards, Janet W; McElrath, Thomas F

2017-03-01

Higher concentrations of certain phthalate metabolites are associated with adverse reproductive and pregnancy outcomes, as well as poor infant/child health outcomes. In non-pregnant populations, phthalate metabolite concentrations vary by race/ethnicity. Few studies have documented racial/ethnic differences between phthalate metabolite concentrations at multiple time points across the full-course of pregnancy. The objective of the study was to characterize the change in phthalate metabolite concentrations by race/ethnicity across multiple pregnancy time points. Women were participants in a prospectively collected pregnancy cohort who delivered at term (≥37 weeks) and had available urinary phthalate metabolite concentrations for ≥3 time points across full-term pregnancies (n=350 women). We assessed urinary concentrations of eight phthalate metabolites that were log-transformed and specific gravity-adjusted. We evaluated the potential racial/ethnic differences in phthalate metabolite concentrations at baseline (median 10 weeks gestation) using ANOVA and across pregnancy using linear mixed models to calculate the percent change and 95% confidence intervals adjusted for sociodemographic and lifestyle factors. Almost 30% of the population were non-Hispanic black or Hispanic. With the exception of mono-(3-carboxypropyl) (MCPP) and di-ethylhexyl phthalate (DEHP) metabolites, baseline levels of phthalate metabolites were significantly higher in non-whites (P<0.05). When evaluating patterns by race/ethnicity, mono-ethyl phthalate (MEP) and MCPP had significant percent changes across pregnancy. MEP was higher in Hispanics at baseline and decreased in mid-pregnancy but increased in late pregnancy for non-Hispanic blacks. MCPP was substantially higher in non-Hispanic blacks at baseline but decreased later in pregnancy. Across pregnancy, non-Hispanic black and Hispanic women had higher concentrations of certain phthalate metabolites. These differences may have implications for racial/ethnic differences in adverse pregnancy and child health outcomes.

Risk factor assessment of endoscopically removed malignant colorectal polyps

PubMed Central

Netzer, P; Forster, C; Biral, R; Ruchti, C; Neuweiler, J; Stauffer, E; Schonegg, R; Maurer, C; Husler, J; Halter, F; Schmassmann, A

1998-01-01

Background—Malignant colorectal polyps are defined as endoscopically removed polyps with cancerous tissue which has invaded the submucosa. Various histological criteria exist for managing these patients. 
Aims—To determine the significance of histological findings of patients with malignant polyps. 
Methods—Five pathologists reviewed the specimens of 85 patients initially diagnosed with malignant polyps. High risk malignant polyps were defined as having one of the following: incomplete polypectomy, a margin not clearly cancer-free, lymphatic or venous invasion, or grade III carcinoma. Adverse outcome was defined as residual cancer in a resection specimen and local or metastatic recurrence in the follow up period (mean 67months). 
Results—Malignant polyps were confirmed in 70 cases. In the 32 low risk malignant polyps, no adverse outcomes occurred; 16(42%) of the 38 patients with high risk polyps had adverse outcomes (p<0.001). Independent adverse risk factors were incomplete polypectomy and a resected margin not clearly cancer-free; all other risk factors were only associated with adverse outcome when in combination. 
Conclusion—As no patients with low risk malignant polyps had adverse outcomes, polypectomy alone seems sufficient for these cases. In the high risk group, surgery is recommended when either of the two independent risk factors, incomplete polypectomy or a resection margin not clearly cancer-free, is present or if there is a combination of other risk factors. As lymphatic or venous invasion or grade III cancer did not have an adverse outcome when the sole risk factor, operations in such cases should be individually assessed on the basis of surgical risk. 

 Keywords: malignant polyps; colon cancer; colonoscopy; polypectomy; histology PMID:9824349

Coexistence of Low Vitamin D and High Fibroblast Growth Factor-23 Plasma Levels Predicts an Adverse Outcome in Patients with Coronary Artery Disease

PubMed Central

Tuñón, José; Cristóbal, Carmen; Tarín, Nieves; Aceña, Álvaro; González-Casaus, María Luisa; Huelmos, Ana; Alonso, Joaquín; Lorenzo, Óscar; González-Parra, Emilio; Mahíllo-Fernández, Ignacio; Pello, Ana María; Carda, Rocío; Farré, Jerónimo; Rodríguez-Artalejo, Fernando

2014-01-01

Objective Vitamin D and fibroblast growth factor-23 (FGF-23) are related with cardiovascular disorders. We have investigated the relationship of calcidiol (vitamin D metabolite) and FGF-23 plasma levels with the incidence of adverse outcomes in patients with coronary artery disease. Methods Prospective follow-up study of 704 outpatients, attending the departments of Cardiology of four hospitals in Spain, 6–12 months after an acute coronary event. Baseline calcidiol, FGF-23, parathormone, and phosphate plasma levels were assessed. The outcome was the development of acute ischemic events (any acute coronary syndrome, stroke, or transient ischemic attack), heart failure, or death. Cox regression adjusted for the main confounders was performed. Results Calcidiol levels showed a moderate-severe decrease in 57.3% of cases. Parathormone, FGF-23, and phosphate levels were increased in 30.0%, 11.5% and 0.9% of patients, respectively. Only 22.4% of patients had glomerular filtration rate<60 ml/min1.73 m2. After a mean follow-up was 2.15±0.99 years, 77 patients developed the outcome. Calcidiol (hazard ratio [HR] = 0.67; 95% confidence interval [CI] = 0.48–0.94; p = 0.021) and FGF-23 (HR = 1.13; 95% CI = 1.04–1.23; p = 0.005) plasma levels predicted independently the outcome. There was a significant interaction between calcidiol and FGF-23 levels (p = 0.025). When the population was divided according to FGF-23 levels, calcidiol still predicted the outcome independently in patients with FGF-23 levels higher than the median (HR = 0.50; 95% CI = 0.31–0.80; p = 0.003) but not in those with FGF-23 levels below this value (HR = 1.03; 95% CI = 0.62–1.71; p = 0.904). Conclusions Abnormalities in mineral metabolism are frequent in patients with stable coronary artery disease. In this population, low calcidiol plasma levels predict an adverse prognosis in the presence of high FGF-23 levels. PMID:24748388

Usefulness of fetal urine production measurement for prediction of perinatal outcomes in uteroplacental insufficiency.

PubMed

Lee, Seung Mi; Jun, Jong Kwan; Kim, Su Ah; Lee, Eun Ja; Kim, Byoung Jae; Park, Chan-Wook; Park, Joong Shin

2014-12-01

To evaluate whether fetal urine production measurement is useful for predicting adverse outcomes in patients with uteroplacental insufficiency. We enrolled patients with uteroplacental insufficiency at 24 to 40 weeks' gestation and normal pregnancies matched for gestational age and divided them into 3 groups according to perinatal outcomes: group 1 (n = 141), a control group of normal pregnancies; group 2 (n = 29), uteroplacental insufficiency without adverse outcomes; and group 3 (n = 18), uteroplacental insufficiency with adverse outcomes. An adverse outcome was defined as 1 or more of the following: (1) cesarean delivery because of fetal distress; (2) admission to the neonatal intensive care unit; (3) cord arterial pH less than 7.15 at birth; and (4) low 5-minute Apgar score (<7). The fetal urine production rate was obtained by serial bladder volume measurement using virtual organ computer-aided analysis. For bladder volume determination, we scanned the bladder in the 3-dimensional mode and defined the bladder surface contour in the reference plane, repeating the rotation of the reference plane with an angle of 30° and determining the surface contour on each plane. Statistical methods, including the Mann-Whitney U test, Fisher exact test, χ(2) test, and Kruskal-Wallis analysis of variance, were used. Group 3 had a lower mean fetal urine production rate than groups 1 and 2, whereas the urine production rate was not different between groups 1 and 2 (group 1, 49.0 mL/h; group 2, 59.4 mL/h; group 3, 20.7 mL/h; P < .001 between groups 1 and 3 and between groups 2 and 3). This difference between groups 2 and 3 remained significant after adjusting for the amniotic fluid index, umbilical artery Doppler pulsatility index, and presence of fetal growth restriction. Uteroplacental insufficiency cases with adverse perinatal outcomes had a lower fetal urine production rate than those without adverse outcomes. This difference might be used to predict adverse perinatal outcomes in uteroplacental insufficiency. © 2013 by the American Institute of Ultrasound in Medicine.

Cumulative Adversity Sensitizes Neural Response to Acute Stress: Association with Health Symptoms

PubMed Central

Seo, Dongju; Tsou, Kristen A; Ansell, Emily B; Potenza, Marc N; Sinha, Rajita

2014-01-01

Cumulative adversity (CA) increases stress sensitivity and risk of adverse health outcomes. However, neural mechanisms underlying these associations in humans remain unclear. To understand neural responses underlying the link between CA and adverse health symptoms, the current study assessed brain activity during stress and neutral-relaxing states in 75 demographically matched, healthy individuals with high, mid, and low CA (25 in each group), and their health symptoms using the Cornell Medical Index. CA was significantly associated with greater adverse health symptoms (P=0.01) in all participants. Functional magnetic resonance imaging results indicated significant associations between CA scores and increased stress-induced activity in the lateral prefrontal cortex, insula, striatum, right amygdala, hippocampus, and temporal regions in all 75 participants (p<0.05, whole-brain corrected). In addition to these regions, the high vs low CA group comparison revealed decreased stress-induced activity in the medial orbitofrontal cortex (OFC) in the high CA group (p<0.01, whole-brain corrected). Specifically, hypoactive medial OFC and hyperactive right hippocampus responses to stress were each significantly associated with greater adverse health symptoms (p<0.01). Furthermore, an inverse correlation was found between activity in the medial OFC and right hippocampus (p=0.01). These results indicate that high CA sensitizes limbic–striatal responses to acute stress and also identifies an important role for stress-related medial OFC and hippocampus responses in the effects of CA on increasing vulnerability to adverse health consequences. PMID:24051900

Cumulative adversity sensitizes neural response to acute stress: association with health symptoms.

PubMed

Seo, Dongju; Tsou, Kristen A; Ansell, Emily B; Potenza, Marc N; Sinha, Rajita

2014-02-01

Cumulative adversity (CA) increases stress sensitivity and risk of adverse health outcomes. However, neural mechanisms underlying these associations in humans remain unclear. To understand neural responses underlying the link between CA and adverse health symptoms, the current study assessed brain activity during stress and neutral-relaxing states in 75 demographically matched, healthy individuals with high, mid, and low CA (25 in each group), and their health symptoms using the Cornell Medical Index. CA was significantly associated with greater adverse health symptoms (P=0.01) in all participants. Functional magnetic resonance imaging results indicated significant associations between CA scores and increased stress-induced activity in the lateral prefrontal cortex, insula, striatum, right amygdala, hippocampus, and temporal regions in all 75 participants (p<0.05, whole-brain corrected). In addition to these regions, the high vs low CA group comparison revealed decreased stress-induced activity in the medial orbitofrontal cortex (OFC) in the high CA group (p<0.01, whole-brain corrected). Specifically, hypoactive medial OFC and hyperactive right hippocampus responses to stress were each significantly associated with greater adverse health symptoms (p<0.01). Furthermore, an inverse correlation was found between activity in the medial OFC and right hippocampus (p=0.01). These results indicate that high CA sensitizes limbic-striatal responses to acute stress and also identifies an important role for stress-related medial OFC and hippocampus responses in the effects of CA on increasing vulnerability to adverse health consequences.

Effects of extended work shifts and shift work on patient safety, productivity, and employee health.

PubMed

Keller, Simone M

2009-12-01

It is estimated 1.3 million health care errors occur each year and of those errors 48,000 to 98,000 result in the deaths of patients (Barger et al., 2006). Errors occur for a variety of reasons, including the effects of extended work hours and shift work. The need for around-the-clock staff coverage has resulted in creative ways to maintain quality patient care, keep health care errors or adverse events to a minimum, and still meet the needs of the organization. One way organizations have attempted to alleviate staff shortages is to create extended work shifts. Instead of the standard 8-hour shift, workers are now working 10, 12, 16, or more hours to provide continuous patient care. Although literature does support these staffing patterns, it cannot be denied that shifts beyond the traditional 8 hours increase staff fatigue, health care errors, and adverse events and outcomes and decrease alertness and productivity. This article includes a review of current literature on shift work, the definition of shift work, error rates and adverse outcomes related to shift work, health effects on shift workers, shift work effects on older workers, recommended optimal shift length, positive and negative effects of shift work on the shift worker, hazards associated with driving after extended shifts, and implications for occupational health nurses. Copyright 2009, SLACK Incorporated.

Three dimensional rotational angiography for assessment of coronary arteries during melody valve implantation: introducing a technique that may improve outcomes.

PubMed

Pockett, C R; Moore, J W; El-Said, H G

2017-02-01

Adverse events from Melody valve implantation may be catastrophic. To date a role for three dimensional rotational angiography of the aortic root (3DRAA) during Melody valve implantation has not been established. To describe the role of 3DRAA in the assessment of Melody valve candidacy and to demonstrate that it may improve outcomes. All patients who underwent cardiac catheterisation for Melody valve implantation and 3DRAA between August 2013 and February 2015 were reviewed. 31 patients had 3DRAA with balloon sizing. Ten were deemed not Melody candidates (5 coronary compression, 2 aortic root distortion with cusp flattening, 2 RVOT was too large, and 1 had complex branch stenosis and a short landing zone). Of the 21 patients who were Melody candidates, 12 had conduits, 6 prosthetic valves and 3 native RVOTs. In patients with conduits, the technique of stenting the conduit prior to dilation was used after measuring the distance between the conduit and the coronary arteries on 3DRAA. In the Melody patients, we had 100% procedural success and no serious adverse events (coronary compression, tears, stent fracture or endocarditis). As a tool for case selection, 3DRAA may facilitate higher procedural success and decreased risk of serious adverse events. Furthermore, 3D rotational angiography allows stenting of the conduit prior to dilation, which may prevent tears and possibly endocarditis.

Taming the Flames: Targeting White Adipose Tissue Browning in Hypermetabolic Conditions.

PubMed

Abdullahi, Abdikarim; Jeschke, Marc G

2017-12-01

In this era of increased obesity and diabetes prevalence, the browning of white adipose tissue (WAT) has emerged as a promising therapeutic target to induce weight loss and improve insulin sensitivity in this population. The browning process entails a shift in the WAT from primarily storing excess energy to the dissipation of energy as heat. However, this idealistic view of WAT browning being the savior of the metabolic syndrome has been criticized by studies in burn and cancer patients that have shown browning to be detrimental rather than beneficial. In fact, in the context of hypermetabolic states, the browning of WAT has presented with substantial clinical adverse outcomes related to cachexia, hepatic steatosis, and muscle catabolism. Therefore, the previous thought construct of understanding browning as an all-beneficial physiologic event has now been met with skepticism. In this review, we focus on current knowledge of browning of WAT and its adverse metabolic alterations during hypermetabolic states. We also discuss the regulators and signaling pathways involved in the browning process and their potential for being targeted by new or existing drugs to inhibit or alleviate browning, potentially leading to decreased hypermetabolism and improved clinical outcomes. Lastly, the imminent clinical applications of pharmacological agents are explored in the perspective of attenuating WAT browning and its associated adverse side effects reported in burn patients. Copyright © 2017 Endocrine Society.

Intrauterine growth restriction decreases pulmonary alveolar and vessel growth and causes pulmonary artery endothelial cell dysfunction in vitro in fetal sheep

PubMed Central

Seedorf, Gregory J.; Brown, Alicia; Roe, Gates; O'Meara, Meghan C.; Gien, Jason; Tang, Jen-Ruey; Abman, Steven H.

2011-01-01

Intrauterine growth restriction (IUGR) increases the risk for bronchopulmonary dysplasia (BPD). Abnormal lung structure has been noted in animal models of IUGR, but whether IUGR adversely impacts fetal pulmonary vascular development and pulmonary artery endothelial cell (PAEC) function is unknown. We hypothesized that IUGR would decrease fetal pulmonary alveolarization, vascular growth, and in vitro PAEC function. Studies were performed in an established model of severe placental insufficiency and IUGR induced by exposing pregnant sheep to elevated temperatures. Alveolarization, quantified by radial alveolar counts, was decreased 20% (P < 0.005) in IUGR fetuses. Pulmonary vessel density was decreased 44% (P < 0.01) in IUGR fetuses. In vitro, insulin increased control PAEC migration, tube formation, and nitric oxide (NO) production. This response was absent in IUGR PAECs. VEGFA stimulated tube formation, and NO production also was absent. In control PAECs, insulin increased cell growth by 68% (P < 0.0001). Cell growth was reduced in IUGR PAECs by 29% at baseline (P < 0.01), and the response to insulin was attenuated (P < 0.005). Despite increased basal and insulin-stimulated Akt phosphorylation in IUGR PAECs, endothelial NO synthase (eNOS) protein expression as well as basal and insulin-stimulated eNOS phosphorylation were decreased in IUGR PAECs. Both VEGFA and VEGFR2 also were decreased in IUGR PAECs. We conclude that fetuses with IUGR are characterized by decreased alveolar and vascular growth and PAEC dysfunction in vitro. This may contribute to the increased risk for adverse respiratory outcomes and BPD in infants with IUGR. PMID:21873446

Continued Statin Prescriptions After Adverse Reactions and Patient Outcomes: A Cohort Study.

PubMed

Zhang, Huabing; Plutzky, Jorge; Shubina, Maria; Turchin, Alexander

2017-08-15

Many patients discontinue statin treatment, often after having a possible adverse reaction. The risks and benefits of continued statin therapy after an adverse reaction are not known. To examine the relationship between continuation of statin therapy (any prescription within 12 months after an adverse reaction) and clinical outcomes. Retrospective cohort study. Primary care practices affiliated with 2 academic medical centers. Patients with a presumed adverse reaction to a statin between 2000 and 2011. Information on adverse reactions to statins was obtained from structured electronic medical record data or natural-language processing of narrative provider notes. The primary composite outcome was time to a cardiovascular event (myocardial infarction or stroke) or death. Most (81%) of the adverse reactions to statins were identified from the text of electronic provider notes. Among 28 266 study patients, 19 989 (70.7%) continued receiving statin prescriptions after the adverse reaction. Four years after the presumed adverse event, the cumulative incidence of the composite primary outcome was 12.2% for patients with continued statin prescriptions, compared with 13.9% for those without them (difference, 1.7% [95% CI, 0.8% to 2.7%]; P < 0.001). In a secondary analysis of 7604 patients for whom a different statin was prescribed after the adverse reaction, 2014 (26.5%) had a documented adverse reaction to the second statin, but 1696 (84.2%) of those patients continued receiving statin prescriptions. The risk for recurrent adverse reactions to statins could not be established for the entire sample. It was also not possible to determine whether patients actually took the statins. Continued statin prescriptions after an adverse reaction were associated with a lower incidence of death and cardiovascular events. Chinese National Key Program of Clinical Science, National Natural Science Foundation of China, and Young Scientific Research Fund of Peking Union Medical College Hospital.

Adverse fetal outcome in road accidents: Injury mechanism study and injury criteria development in a pregnant woman finite element model.

PubMed

Auriault, F; Thollon, L; Pérès, J; Behr, M

2016-12-01

This study documents the development of adverse fetal outcome predictors dedicated to the analysis of road accidents involving pregnant women. To do so, a pre-existing whole body finite element model representative of a 50th percentile 26 weeks pregnant woman was used. A total of 8 accident scenarios were simulated with the model positioned on a sled. Each of these scenarios was associated to a risk of adverse fetal outcome based on results from real car crash investigations involving pregnant women from the literature. The use of airbags and accidents involving unbelted occupants were not considered in this study. Several adverse fetal outcome potential predictors were then evaluated with regard to their correlation to this risk of fetal injuries. Three predictors appeared strongly correlated to the risk of adverse fetal outcome: (1) the intra uterine pressure at the placenta fetal side area (r=0.92), (2) the fetal head acceleration (HIC) (r=0.99) and (3) area of utero-placental interface over a strain threshold (r=0.90). Finally, sensitivity analysis against slight variations of the simulation parameters was performed and assess robustness of these criteria. Copyright © 2016 Elsevier Ltd. All rights reserved.

Rates of medical errors and preventable adverse events among hospitalized children following implementation of a resident handoff bundle.

PubMed

Starmer, Amy J; Sectish, Theodore C; Simon, Dennis W; Keohane, Carol; McSweeney, Maireade E; Chung, Erica Y; Yoon, Catherine S; Lipsitz, Stuart R; Wassner, Ari J; Harper, Marvin B; Landrigan, Christopher P

2013-12-04

Handoff miscommunications are a leading cause of medical errors. Studies comprehensively assessing handoff improvement programs are lacking. To determine whether introduction of a multifaceted handoff program was associated with reduced rates of medical errors and preventable adverse events, fewer omissions of key data in written handoffs, improved verbal handoffs, and changes in resident-physician workflow. Prospective intervention study of 1255 patient admissions (642 before and 613 after the intervention) involving 84 resident physicians (42 before and 42 after the intervention) from July-September 2009 and November 2009-January 2010 on 2 inpatient units at Boston Children's Hospital. Resident handoff bundle, consisting of standardized communication and handoff training, a verbal mnemonic, and a new team handoff structure. On one unit, a computerized handoff tool linked to the electronic medical record was introduced. The primary outcomes were the rates of medical errors and preventable adverse events measured by daily systematic surveillance. The secondary outcomes were omissions in the printed handoff document and resident time-motion activity. Medical errors decreased from 33.8 per 100 admissions (95% CI, 27.3-40.3) to 18.3 per 100 admissions (95% CI, 14.7-21.9; P < .001), and preventable adverse events decreased from 3.3 per 100 admissions (95% CI, 1.7-4.8) to 1.5 (95% CI, 0.51-2.4) per 100 admissions (P = .04) following the intervention. There were fewer omissions of key handoff elements on printed handoff documents, especially on the unit that received the computerized handoff tool (significant reductions of omissions in 11 of 14 categories with computerized tool; significant reductions in 2 of 14 categories without computerized tool). Physicians spent a greater percentage of time in a 24-hour period at the patient bedside after the intervention (8.3%; 95% CI 7.1%-9.8%) vs 10.6% (95% CI, 9.2%-12.2%; P = .03). The average duration of verbal handoffs per patient did not change. Verbal handoffs were more likely to occur in a quiet location (33.3%; 95% CI, 14.5%-52.2% vs 67.9%; 95% CI, 50.6%-85.2%; P = .03) and private location (50.0%; 95% CI, 30%-70% vs 85.7%; 95% CI, 72.8%-98.7%; P = .007) after the intervention. Implementation of a handoff bundle was associated with a significant reduction in medical errors and preventable adverse events among hospitalized children. Improvements in verbal and written handoff processes occurred, and resident workflow did not change adversely.

The effects of exercise on cardiovascular biomarkers in patients with chronic heart failure.

PubMed

Ahmad, Tariq; Fiuzat, Mona; Mark, Daniel B; Neely, Ben; Neely, Megan; Kraus, William E; Kitzman, Dalane W; Whellan, David J; Donahue, Mark; Zannad, Faiez; Piña, Ileana L; Adams, Kirkwood; O'Connor, Christopher M; Felker, G Michael

2014-02-01

Exercise training is recommended for chronic heart failure (HF) patients to improve functional status and reduce risk of adverse outcomes. Elevated plasma levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP), high-sensitivity C-reactive protein (hs-CRP), and cardiac troponin T (cTnT) are associated with increased risk of adverse outcomes in this patient population. Whether exercise training leads to improvements in biomarkers and how such improvements relate to clinical outcomes are unclear. Amino-terminal pro-brain natriuretic peptide, hs-CRP, and cTnT levels were assessed at baseline and 3 months in a cohort of 928 subjects from the HF-ACTION study, a randomized clinical trial of exercise training versus usual care in chronic HF patients with reduced left ventricular ejection fraction (<35%). Linear and logistic regressions were used to assess 3-month biomarker levels as a function of baseline value, treatment assignment (exercise training vs usual care), and volume of exercise. Linear regression and Cox proportional hazard modeling were used to evaluate the relations between changes in biomarker levels and clinical outcomes of interest that included change in peak oxygen consumption (peak VO2), hospitalizations, and mortality. Exercise training was not associated with significant changes in levels of NT-proBNP (P = .10), hs-CRP (P = .80), or detectable cTnT levels (P = .83) at 3 months. Controlling for baseline biomarker levels or volume of exercise did not alter these findings. Decreases in plasma concentrations of NT-proBNP, but not hs-CRP or cTnT, were associated with increases in peak VO2 (P < .001) at 3 months and decreased risk of hospitalizations or mortality (P ≤ .04), even after adjustment for a comprehensive set of known predictors. Exercise training did not lead to meaningful changes in biomarkers of myocardial stress, inflammation, or necrosis in patients with chronic HF. Only improvements in NT-proBNP translated to reductions in peak VO2 and reduced risk of clinical events. © 2014.

Pregnancy outcomes in women taking probiotics or prebiotics: a systematic review and meta-analysis.

PubMed

Jarde, Alexander; Lewis-Mikhael, Anne-Mary; Moayyedi, Paul; Stearns, Jennifer C; Collins, Stephen M; Beyene, Joseph; McDonald, Sarah D

2018-01-08

Probiotics are living microorganisms that, when administered in adequate amounts, confer a health benefit. It has been speculated that probiotics might help prevent preterm birth, but in two previous systematic reviews possible major increases in this risk have been suggested. Our objective was to perform a systematic review and meta-analysis of the risk of preterm birth and other adverse pregnancy outcomes in pregnant women taking probiotics, prebiotics or synbiotics. We searched six electronic databases (MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, Web of Science's Core collection and BIOSIS Preview) up to September 2016 and contacted authors for additional data. We included randomized controlled trials in which women with a singleton pregnancy received a probiotic, prebiotic or synbiotic intervention. Two independent reviewers extracted data using a piloted form and assessed the risk of bias using the Cochrane risk of bias tool. We used random-effects meta-analyses to pool the results. We identified 2574 publications, screened 1449 non-duplicate titles and abstracts and read 160 full text articles. The 49 publications that met our inclusion criteria represented 27 studies. No study used synbiotics, one used prebiotics and the rest used probiotics. Being randomized to take probiotics during pregnancy neither increased nor decreased the risk of preterm birth < 34 weeks (RR 1.03, 95% CI 0.29-3.64, I 2 0%, 1017 women in 5 studies), preterm birth < 37 weeks (RR 1.08, 95% CI 0.71-1.63, I 2 0%, 2484 women in 11 studies), or most of our secondary outcomes, including gestational diabetes mellitus. We found no evidence that taking probiotics or prebiotics during pregnancy either increases or decreases the risk of preterm birth or other infant and maternal adverse pregnancy outcomes. We prospectively published the protocol for this study in the PROSPERO database ( CRD42016048129 ).

Effects of psychosocial characteristics of work on pregnancy outcomes: a critical review.

PubMed

Mutambudzi, Miriam; Meyer, John D; Warren, Nicholas; Reisine, Susan

2011-05-01

Birth outcomes may influence subsequent susceptibility to chronic diseases. With the increased number of women who continue to work during pregnancy, occupational stress has been hypothesized to be a potential contributor to adverse reproductive health outcomes. The Job Demand and Control model has been primarily used in investigating associations between work-related stress and outcomes such as preterm delivery, low birth weight, and spontaneous abortion. A literature review of occupational factors that have been associated with adverse reproductive outcomes was conducted. In studies assessing preterm delivery and low birth weight, some evidence has suggested a modest association with work-related stress but has not been conclusive. In the literature on psychosocial characteristics of work and spontaneous abortion, job strain alone was often not associated with adverse outcomes. However the presence of other risk factors resulted in a synergistic effect which strengthened the odds of an adverse outcome. Future studies should use a prospective design with a large study sample, in which work-related stress exposure data are collected before or in the early stages of the pregnancy. In addition, future research should measure psychosocial characteristics of work both objectively and subjectively.

Sulfadoxine-Pyrimethamine Exhibits Dose-Response Protection Against Adverse Birth Outcomes Related to Malaria and Sexually Transmitted and Reproductive Tract Infections.

PubMed

Chico, R Matthew; Chaponda, Enesia Banda; Ariti, Cono; Chandramohan, Daniel

2017-04-15

We conducted a prospective cohort study in Zambia among pregnant women who received intermittent preventive treatment using sulfadoxine-pyrimethamine (IPTp-SP). We calculated the odds ratios (ORs) of adverse birth outcomes by IPTp-SP exposure, 0-1 dose (n = 126) vs ≥2 doses (n = 590) and ≥2 doses (n = 310) vs ≥3 doses (n = 280) in 7 categories of malaria infection and sexually transmitted and reproductive tract infections (STIs/RTIs). We found no significant differences in baseline prevalence of infection across IPTp-SP exposure groups. However, among women given 2 doses compared to 0-1 dose, the odds of any adverse birth outcome were reduced 45% (OR, 0.55; 95% confidence interval [CI], 0.36, 0.86) and 13% further with ≥3 doses (OR, 0.43; 95% CI, 0.27, 0.68). Two or more doses compared to 0-1 dose reduced preterm delivery by 58% (OR, 0.42; 95% CI, 0.27, 0.67) and 21% further with ≥3 doses (OR, 0.21; 95% CI, 0.13, 0.35). Women with malaria at enrollment who received ≥2 doses vs 0-1 had 76% lower odds of any adverse birth outcome (OR, 0.24; 95% 0.09, 0.66), and Neisseria gonorrhoeae and/or Chlamydia trachomatis had 92% lower odds of any adverse birth outcome (OR, 0.08; 95% CI, 0.01, 0.64). Women with neither a malaria infection nor STIs/RTIs who received ≥2 doses had 73% fewer adverse birth outcomes (OR, 0.27; 95% CI, 0.11, 0.68). IPTp-SP appears to protect against malaria, STIs/RTIs, and other unspecified causes of adverse birth outcome. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Factors associated with death and loss to follow-up in children on antiretroviral care in Mingalardon Specialist Hospital, Myanmar, 2006–2016

PubMed Central

Satyanarayana, Srinath; Isaakidis, Petros; Hone, San; Khaing, Aye Aye; Nguyen Binh, Hoa; Oo, Htun Nyunt

2018-01-01

Background Myanmar National AIDS programme’s priority is to improve the survival of all people living with HIV by providing anti-retroviral therapy (ART) care. More than 7200 children (aged <15 years) have been enrolled into ART care from 2005 to 2016. A previous study showed that ~11% children on ART care had either died or were lost to follow-up by 60 months. Factors associated with death and lost-to follow-up (adverse outcomes) have not been previously studied. Objectives To describe the association between demographic and clinical characteristics at enrollment into ART care with adverse outcomes. Methods Cohort study using records of children enrolled for ART care at Mingalardon Specialist Hospital (main Paediatric ART center in Myanmar) from 2006–2016. We used multivariable Cox proportional hazards regression models for analysis. Results 1,159 children were enrolled for ART care and they contributed a total of 1.45 million person-days of follow-up period. 112 (10%) had an adverse outcome during the follow-up time period (55 deaths, 57 lost to follow-up). Enrollment into the ART care through in-patient care department of the hospital, CD4 Cell count <50/mm3, enrollment during changing ART guidelines (different ART eligibility criteria and preferred ART regimen) were independently associated with higher hazards of adverse outcome. Receiving protease inhibitor-based ART regimen at enrollment was independently associated with lower hazards of adverse outcome. Age, sex, residing in urban or rural areas, WHO clinical stage, having TB at the time of enrollment, receiving cotrimoxazole prophylaxis were not statistically associated with adverse outcomes. Conclusion Our analysis reconfirms good survival of children on ART care (including those with TB). The characteristics associated with adverse outcomes (other than CD4 cell count<50) are surrogates of some unmeasured underlying health system/ patient related factors that needs further exploration to improve the survival of children on ART care. PMID:29621302

Factors associated with death and loss to follow-up in children on antiretroviral care in Mingalardon Specialist Hospital, Myanmar, 2006-2016.

PubMed

Kaung Nyunt, Kay Khaing; Han, Wai Wai; Satyanarayana, Srinath; Isaakidis, Petros; Hone, San; Khaing, Aye Aye; Nguyen Binh, Hoa; Oo, Htun Nyunt

2018-01-01

Myanmar National AIDS programme's priority is to improve the survival of all people living with HIV by providing anti-retroviral therapy (ART) care. More than 7200 children (aged <15 years) have been enrolled into ART care from 2005 to 2016. A previous study showed that ~11% children on ART care had either died or were lost to follow-up by 60 months. Factors associated with death and lost-to follow-up (adverse outcomes) have not been previously studied. To describe the association between demographic and clinical characteristics at enrollment into ART care with adverse outcomes. Cohort study using records of children enrolled for ART care at Mingalardon Specialist Hospital (main Paediatric ART center in Myanmar) from 2006-2016. We used multivariable Cox proportional hazards regression models for analysis. 1,159 children were enrolled for ART care and they contributed a total of 1.45 million person-days of follow-up period. 112 (10%) had an adverse outcome during the follow-up time period (55 deaths, 57 lost to follow-up). Enrollment into the ART care through in-patient care department of the hospital, CD4 Cell count <50/mm3, enrollment during changing ART guidelines (different ART eligibility criteria and preferred ART regimen) were independently associated with higher hazards of adverse outcome. Receiving protease inhibitor-based ART regimen at enrollment was independently associated with lower hazards of adverse outcome. Age, sex, residing in urban or rural areas, WHO clinical stage, having TB at the time of enrollment, receiving cotrimoxazole prophylaxis were not statistically associated with adverse outcomes. Our analysis reconfirms good survival of children on ART care (including those with TB). The characteristics associated with adverse outcomes (other than CD4 cell count<50) are surrogates of some unmeasured underlying health system/ patient related factors that needs further exploration to improve the survival of children on ART care.

Gender differences in adverse outcomes after contemporary percutaneous coronary intervention: an analysis from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) percutaneous coronary intervention registry.

PubMed

Duvernoy, Claire S; Smith, Dean E; Manohar, Prerana; Schaefer, Ann; Kline-Rogers, Eva; Share, David; McNamara, Richard; Gurm, Hitinder S; Moscucci, Mauro

2010-04-01

Prior studies have shown a relationship between female gender and adverse outcomes after percutaneous coronary interventions (PCIs). Whether this relationship still exists with contemporary PCI remains to be determined. We evaluated gender differences in clinical outcomes in a large registry of contemporary PCI. Data were prospectively collected from 22,725 consecutive PCIs in a multicenter regional consortium (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) between January 2002 and December 2003. The primary end point was in-hospital all-cause mortality; other clinical outcomes evaluated included in-hospital death, vascular complications, transfusion, postprocedure myocardial infarction, stroke, and a combined major cardiovascular adverse event (MACE) end point including myocardial infarction, death, stroke, emergency coronary artery bypass grafting, and repeated PCI at the same site. Independent predictors of adverse outcomes were identified using multivariate logistic regression analysis. Compared with men, women were older, had a higher prevalence of comorbidities, and had a significantly higher frequency of adverse outcomes after PCI. After adjustment for baseline demographics, comorbidities, clinical presentation, and lesion characteristics, female gender was associated with an increased risk of in-hospital death, vascular complication, blood transfusion, stroke, and MACE. The relationship between female gender and increased risk of death and MACE was no longer present after further adjustment for kidney function and low body surface area. Differences in mortality rates between men and women no longer exist after PCI. However, our data suggest that technological advancements have not completely offset the relationship between gender and adverse outcomes after PCI. Copyright 2010 Mosby, Inc. All rights reserved.

Functional and cognitive impairment, social environment, frailty and adverse health outcomes in older patients with head and neck cancer, a systematic review.

PubMed

van Deudekom, Floor J; Schimberg, Anouk S; Kallenberg, Marije H; Slingerland, Marije; van der Velden, Lily-Ann; Mooijaart, Simon P

2017-01-01

Older head and neck cancer patients are at increased risk for adverse health outcomes, but little is known about which geriatric assessment associates with poor outcome. The aim is to study the association of functional or cognitive impairment, social environment and frailty with adverse health outcomes in patients with head and neck cancer. Four libraries were searched for studies reporting on an association of functional or cognitive impairment, social environment and frailty with adverse outcomes in head and neck cancer patients. Of 4158 identified citations, 31 articles were included. The mean age was ⩾60years in twelve studies (39%). Geriatric conditions were prevalent: between 40 and 50% of the included participants were functional impaired, around 50% had depressive symptoms, and around 40% did not have a partner. Functional impairment was assessed in 18 studies, two studies reported on a cognitive test, eight studies examined mood and social status was depicted by 14 studies. None of the included studies addressed frailty or objectively measured physical capacity such as hand grip strength, gait speed or balance tests. In 64% of the reported associations, a decline in functional or cognitive impairment, mood or social environment was associated with adverse outcomes. Functional and cognitive impairment, depressive symptoms and social isolation are highly prevalent in head and neck cancer patients and associate with high risk of adverse health outcomes. In the future, these measurements may guide decision-making and customize treatments, but more research is needed to further improve and firmly establish clinical usability. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Impact of a Prospective Audit and Feedback Antimicrobial Stewardship Program at a Veterans Affairs Medical Center: A Six-Point Assessment

PubMed Central

Morrill, Haley J.; Caffrey, Aisling R.; Gaitanis, Melissa M.; LaPlante, Kerry L.

2016-01-01

Background Prospective audit and feedback is a core antimicrobial stewardship program (ASP) strategy; however its impact is difficult to measure. Methods Our quasi-experimental study measured the effect of an ASP on clinical outcomes, antimicrobial use, resistance, costs, patient safety (adverse drug events [ADE] and Clostridium difficile infection [CDI]), and process metrics pre- (9/10–10/11) and post-ASP (9/12–10/13) using propensity adjusted and matched Cox proportional-hazards regression models and interrupted time series (ITS) methods. Results Among our 2,696 patients, median length of stay was 1 day shorter post-ASP (5, interquartile range [IQR] 3–8 vs. 4, IQR 2–7 days, p<0.001). Mortality was similar in both periods. Mean broad-spectrum (-11.3%), fluoroquinolone (-27.0%), and anti-pseudomonal (-15.6%) use decreased significantly (p<0.05). ITS analyses demonstrated a significant increase in monthly carbapenem use post-ASP (trend: +1.5 days of therapy/1,000 patient days [1000PD] per month; 95% CI 0.1–3.0). Total antimicrobial costs decreased 14%. Resistance rates did not change in the one-year post-ASP period. Mean CDI rates/10,000PD were low pre- and post-ASP (14.2 ± 10.4 vs. 13.8 ± 10.0, p = 0.94). Fewer patients experienced ADEs post-ASP (6.0% vs. 4.4%, p = 0.06). Conclusions Prospective audit and feedback has the potential to improve antimicrobial use and outcomes, and contain bacterial resistance. Our program demonstrated a trend towards decreased length of stay, broad-spectrum antimicrobial use, antimicrobial costs, and adverse events. PMID:26978263

Reducing blood testing in pediatric patients after heart surgery: a quality improvement project.

PubMed

Delgado-Corcoran, Claudia; Bodily, Stephanie; Frank, Deborah U; Witte, Madolin K; Castillo, Ramon; Bratton, Susan L

2014-10-01

To safely optimize blood testing and costs for pediatric cardiac surgical patients without adversely impacting patient outcomes. This is a quality improvement cohort project with pre- and postintervention groups. University-affiliated pediatric cardiac ICU in a tertiary care children's hospital. All patients were surgical patients for whom Risk Adjustment for Congenital Heart Surgery categories allowed for stratification by complexity. The preintervention group was treated in 2010 and the postintervention group in 2011. Laboratory ordering processes were analyzed, and practice changed to limit standing blood test orders and requires individualized ordering. Three hundred nineteen patients were studied in 2010 and 345 in 2011. Groups were similar in median age, weight, length of stay (ICU length of stay), and Risk Adjustment for Congenital Heart Surgery category. There was a reduction in the total blood tests per patient (24 vs 38; p < 0.0001) and length of stay adjusted tests per patient-day (10.4 vs 14.4; p = 0.0001) in the postintervention group. The largest test reductions were blood gases and single electrolytes. Adverse outcomes, such as extubation failure (6.4% vs 5.6%), central catheter-associated bloodstream infection (2.2 vs 1.5), and hospital mortality (0.6% vs 0.6%), were not significantly different between the groups. Cost analysis demonstrated an overall laboratory cost savings of 32%. In addition, the volume of packed RBC transfusions was also significantly decreased in the postintervention group among the most complex patients (Risk Adjustment for Congenital Heart Surgery, 6). Blood testing rates were safely decreased in postoperative pediatric cardiac patients by changing laboratory ordering practices. In addition, packed RBC transfusion was decreased among the most complex patients.

Maternal obesity alters brain derived neurotrophic factor (BDNF) signaling in the placenta in a sexually dimorphic manner.

PubMed

Prince, Calais S; Maloyan, Alina; Myatt, Leslie

2017-01-01

Obesity is a major clinical problem in obstetrics being associated with adverse pregnancy outcomes and fetal programming. Brain derived neurotrophic factor (BDNF), a validated miR-210 target, is necessary for placental development, fetal growth, glucose metabolism, and energy homeostasis. Plasma BDNF levels are reduced in obese individuals; however, placental BDNF has yet to be studied in the context of maternal obesity. In this study, we investigated the effect of maternal obesity and sexual dimorphism on placental BDNF signaling. BDNF signaling was measured in placentas from lean (pre-pregnancy BMI < 25) and obese (pre-pregnancy BMI>30) women at term without medical complications that delivered via cesarean section without labor. MiRNA-210, BDNF mRNA, proBDNF, and mature BDNF were measured by RT - PCR, ELISA, and Western blot. Downstream signaling via TRKB (BDNF receptor) was measured using Western blot. Maternal obesity was associated with increased miRNA-210 and decreased BDNF mRNA in placentas from female fetuses, and decreased proBDNF in placentas from male fetuses. We also identified decreased mature BDNF in placentas from male fetuses when compared to female fetuses. Mir-210 expression was negatively correlated with mature BDNF protein. TRKB phosphorylated at tyrosine 817, not tyrosine 515, was increased in placentas from obese women. Maternal obesity was associated with increased phosphorylation of MAPK p38 in placentas from male fetuses, but not phosphorylation of ERK p42/44. BDNF regulation is complex and highly regulated. Pre-pregnancy/early maternal obesity adversely affects BDNF/TRKB signaling in the placenta in a sexually dimorphic manner. These data collectively suggest that induction of placental TRKB signaling could ameliorate the placental OB phenotype, thus improving perinatal outcome. Copyright © 2016 Elsevier Ltd. All rights reserved.

Identifying food deserts and swamps based on relative healthy food access: a spatio-temporal Bayesian approach.

PubMed

Luan, Hui; Law, Jane; Quick, Matthew

2015-12-30

Obesity and other adverse health outcomes are influenced by individual- and neighbourhood-scale risk factors, including the food environment. At the small-area scale, past research has analysed spatial patterns of food environments for one time period, overlooking how food environments change over time. Further, past research has infrequently analysed relative healthy food access (RHFA), a measure that is more representative of food purchasing and consumption behaviours than absolute outlet density. This research applies a Bayesian hierarchical model to analyse the spatio-temporal patterns of RHFA in the Region of Waterloo, Canada, from 2011 to 2014 at the small-area level. RHFA is calculated as the proportion of healthy food outlets (healthy outlets/healthy + unhealthy outlets) within 4-km from each small-area. This model measures spatial autocorrelation of RHFA, temporal trend of RHFA for the study region, and spatio-temporal trends of RHFA for small-areas. For the study region, a significant decreasing trend in RHFA is observed (-0.024), suggesting that food swamps have become more prevalent during the study period. For small-areas, significant decreasing temporal trends in RHFA were observed for all small-areas. Specific small-areas located in south Waterloo, north Kitchener, and southeast Cambridge exhibited the steepest decreasing spatio-temporal trends and are classified as spatio-temporal food swamps. This research demonstrates a Bayesian spatio-temporal modelling approach to analyse RHFA at the small-area scale. Results suggest that food swamps are more prevalent than food deserts in the Region of Waterloo. Analysing spatio-temporal trends of RHFA improves understanding of local food environment, highlighting specific small-areas where policies should be targeted to increase RHFA and reduce risk factors of adverse health outcomes such as obesity.

Dexmedetomidine for Refractory Adrenergic Crisis in Familial Dysautonomia

PubMed Central

Dillon, Ryan C.; Palma, Jose-Alberto; Spalink, Christy L.; Altshuler, Diana; Norcliffe-Kaufmann, Lucy; Fridman, David; Papadopoulos, John; Kaufmann, Horacio

2016-01-01

Objective Adrenergic crises are a cardinal feature of familial dysautonomia (FD). Traditionally, adrenergic crisis have been treated with the sympatholytic agent clonidine or with benzodiazepines, which can cause excessive sedation and respiratory depression. Dexmedetomidine is an α2A-adrenergic agonist with greater selectivity and shorter half-life than clonidine. We aimed to evaluate the preliminary effectiveness and safety of intravenous dexmedetomidine in the treatment of refractory adrenergic crisis in patients with FD. Methods Retrospective chart review of patients with genetically confirmed FD who received intravenous dexmedetomidine for refractory adrenergic crises. The primary outcome was preliminary effectiveness of dexmedetomidine defined as change in blood pressure (BP) and heart rate (HR) 1-hour after the initiation of dexmedetomidine. Secondary outcomes included incidence of adverse events related to dexmedetomidine, hospital and intensive care unit (ICU) length of stay, and hemodynamic parameters 12-hours after dexmedetomidine cessation. Results Nine patients over 14 admissions were included in the final analysis. At 1-hour after the initiation of dexmedetomidine, systolic BP decreased from 160±7 to 122±7 mmHg (p=0.0005), diastolic BP decreased from 103±6 to 65±8 (p=0.0003), and HR decreased from 112±4 to 100±5 bpm (p=0.0047). The median total adverse events during dexmedetomidine infusion was 1 per admission. Median hospital length of stay was 9 days (IQR, 3 – 11 days) and median ICU length of stay was 7 days (IQR, 3 – 11 days). Conclusions Intravenous dexmedetomidine is safe in patients with FD and appears to be effective to treat refractory adrenergic crisis. Dexmedetomidine may be considered in FD patients who do not respond to conventional clonidine and benzodiazepine pharmacotherapy. PMID:27752785

RACIAL RESIDENTIAL SEGREGATION AND ADVERSE BIRTH OUTCOMES

EPA Science Inventory

INTRODUCTION. The disparity between black and white women's adverse birth outcomes has been subject to much investigation, yet the factors underlying its persistence remain elusive, which has encouraged research on neighborhood-level influences, including racial residential segr...

Data-driven development of AOP knowledge

EPA Science Inventory

The Adverse Outcome Pathway framework represents a systematic way to organize mechanistic information underlying toxicology, and it is specifically designed to connect early stage molecular perturbations by chemicals and other stressors with adverse outcomes in humans and wildlif...

Adverse outcome pathway (AOP) development II: Best practices

EPA Science Inventory

Organization of existing and emerging toxicological knowledge into adverse outcome pathway (AOP) descriptions can facilitate greater application of mechanistic data, including high throughput in vitro, high content omics and imaging, and biomarkers, in risk-based decision-making....

Effects of transplacental exposure to environmental pollutants on birth outcomes in a multiethnic population.

PubMed Central

Perera, Frederica P; Rauh, Virginia; Tsai, Wei-Yann; Kinney, Patrick; Camann, David; Barr, Dana; Bernert, Tom; Garfinkel, Robin; Tu, Yi-Hsuan; Diaz, Diurka; Dietrich, Jessica; Whyatt, Robin M

2003-01-01

Inner-city, minority populations are high-risk groups for adverse birth outcomes and also are more likely to be exposed to environmental contaminants, including environmental tobacco smoke (ETS), polycyclic aromatic hydrocarbons (PAHs), and pesticides. In a sample of 263 nonsmoking African-American and Dominican women, we evaluated the effects on birth outcomes of prenatal exposure to airborne PAHs monitored during pregnancy by personal air sampling, along with ETS estimated by plasma cotinine, and an organophosphate pesticide (OP) estimated by plasma chlorpyrifos (CPF). Plasma CPF was used as a covariate because it was the most often detected in plasma and was highly correlated with other pesticides frequently detected in plasma. Among African Americans, high prenatal exposure to PAHs was associated with lower birth weight (p = 0.003) and smaller head circumference (p = 0.01) after adjusting for potential confounders. CPF was associated with decreased birth weight and birth length overall (p = 0.01 and p = 0.003, respectively) and with lower birth weight among African Americans (p = 0.04) and reduced birth length in Dominicans (p < 0.001), and was therefore included as a covariate in the model with PAH. After controlling for CPF, relationships between PAHs and birth outcomes were essentially unchanged. In this analysis, PAHs and CPF appear to be significant independent determinants of birth outcomes. Further analyses of pesticides will be carried out. Possible explanations of the failure to find a significant effect of PAHs in the Hispanic subsample are discussed. This study provides evidence that environmental pollutants at levels currently encountered in New York City adversely affect fetal development. PMID:12573906

Nutritional Care of Gastric Cancer Patients with Clinical Outcomes and Complications: A Review.

PubMed

Choi, Wook Jin; Kim, Jeongseon

2016-04-01

The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer.

The influence of the built environment on adverse birth outcomes.

PubMed

Woods, N; Gilliland, J; Seabrook, J A

2017-01-01

Adverse birth outcomes are associated with neonatal morbidity and mortality, and higher risk for coronary heart disease, non-insulin-dependent diabetes and hypertension in adulthood. Although there has been considerable research investigating the association between maternal and environmental factors on adverse birth outcomes, one risk factor, not fully understood, is the influence of the built environment. A search of MEDLINE, Scopus, and Cochrane was conducted to find articles assessing the influence of the built environment on preterm birth (PTB), low birth weight (LBW), and small-for-gestational-age (SGA). In total, 41 studies met our inclusion criteria, and were organized into nine categories: Roadways, Greenness, Power Plants, Gas Stations/Wells, Waste Management, Power Lines, Neighborhood Conditions, Food Environment, and Industry. The most common built environmental variable was roads/traffic, encompassing 17/41 (41%) of the articles reviewed, of which 12/17 (71%) found a significant small to moderate association between high traffic exposure and adverse birth outcomes.

Women's health: periodontitis and its relation to hormonal changes, adverse pregnancy outcomes and osteoporosis.

PubMed

Krejci, Charlene B; Bissada, Nabil F

2012-01-01

To examine the literature with respect to periodontitis and issues specific to women's health, namely, hormonal changes, adverse pregnancy outcomes and osteoporosis. The literature was evaluated to review reported associations between periodontitis and genderspecific issues, namely, hormonal changes, adverse pregnancy outcomes and osteoporosis. Collectively, the literature provided a large body of evidence that supports various associations between periodontitis and hormonal changes, adverse pregnancy outcomes and osteoporosis; however, certain shortcomings were noted with respect to biases involving definitions, sample sizes and confounding variables. Specific cause and effect relationships could not be delineated at this time and neither could definitive treatment interventions. Future research must include randomised controlled trials with consistent definitions, adequate controls and sufficiently large sample sizes in order to clarify specific associations, identify cause and effect relationships, define treatment options and determine treatment interventions which will lessen the untoward effects on the at-risk populations.

The Associations Between Air Pollution and Adverse Pregnancy Outcomes in China.

PubMed

Tan, Yafei; Yang, Rong; Zhao, Jinzhu; Cao, Zhongqiang; Chen, Yawen; Zhang, Bin

2017-01-01

Research on the potential impact of air pollution on the human's health has increased rapidly in recent years. Several studies have suggested that exposure to air pollutants during period of pregnancy which is a crucial time point of mother-fetus development may have long-term and serious impact on adverse pregnancy outcomes. There is lack of review to evaluate the existed epidemiologic evidence on the associations between air pollutants and adverse pregnancy outcomes in China, so we conducted a review to explore the current epidemiological evidence on the effects of air pollutants to pregnancy outcomes and possible mechanisms during the pregnancy process. We used keywords to systematically search all the English and Chinese literatures on studies that were conducted in China. Exposure to air pollutants during pregnancy had shown there were harmful effects for different birth outcomes: preterm birth, low birth weight, stillbirth, birth defects, infertility, and macrosomia fetus. Results on the effects of air pollutants on adverse pregnancy outcomes are small and inconsistent because they vary in their design and methodology. The existed available evidence is compatible with either a small negative effect of air pollutants on pregnancy outcomes or with no effect; therefore, further studies are needed to confirm and quantify the possible associations and potential biologic mechanisms between air pollutants and pregnancy outcomes.

Echocardiographic predictors of adverse outcomes after continuous left ventricular assist device implantation.

PubMed

Topilsky, Yan; Oh, Jae K; Shah, Dipesh K; Boilson, Barry A; Schirger, John A; Kushwaha, Sudhir S; Pereira, Naveen L; Park, Soon J

2011-03-01

The purpose of the study was to identify echocardiographic predictors of adverse outcome in patients implanted with continuous-flow left ventricular assist devices (LVAD). Continuous flow LVAD have become part of the standard of care for the treatment of advanced heart failure. However, knowledge of echocardiographic predictors of outcome after LVAD are lacking. Overall, 83 patients received continuous-flow LVAD (HeartMate II, Thoratec Corporation, Pleasanton, California) from February 2007 to June 2010. The LVAD database, containing various echocardiographic parameters, was examined to analyze their influence on in-hospital mortality, a compound cardiac event (in-hospital mortality or acute right ventricular [RV] dysfunction), and long-term mortality. Eight patients died before discharge (operative mortality 9.6%), and another 15 patients were considered to have acute RV dysfunction immediately after surgery. Patients with relatively small left ventricular end-diastolic diameters (<63 mm) had significantly higher risk for in-hospital mortality (odds ratio [OR]: 0.9; 95% confidence interval [CI]: 0.83 to 0.99; p = 0.04) or occurrence of the compound cardiac event (OR: 0.89; 95% CI: 0.84 to 0.95; p < 0.001). The most significant predictor of outcome was the decreased timing interval between the onset and the cessation of tricuspid regurgitation flow corrected for heart rate (TRDc), a surrogate for early systolic equalization of RV and right atrial pressure. Short TRDc predicted in-hospital mortality (OR: 0.85; 95% CI: 0.74 to 0.97; p = 0.01) and the compound cardiac event (OR: 0.83; 95% CI: 0.74 to 0.91; p < 0.0001). Multivariate analysis based on a logistic regression model demonstrated that the accuracy of predicting the 30-day compound adverse outcome was improved with the addition of echocardiographic variables when added to the commonly used hemodynamic or clinical scores. TRDc predicted long-term survival, with adjusted risk ratios of 0.89 for death from any cause (95% CI: 0.83 to 0.96; p = 0.003) and 0.88 for cardiac-related death (95% CI: 0.77 to 0.98; p = 0.03). The presence of either a relatively small left ventricle (<63 mm) or early systolic equalization of RV and right atrial pressure (short TRDc) demonstrated by echocardiography is associated with increased 30-day morbidity and mortality. Prediction of early adverse outcomes by echocardiographic parameters is additive to laboratory or hemodynamic variables. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Preterm Birth and Adult Wealth: Mathematics Skills Count.

PubMed

Basten, Maartje; Jaekel, Julia; Johnson, Samantha; Gilmore, Camilla; Wolke, Dieter

2015-10-01

Each year, 15 million babies worldwide are born preterm. Preterm birth is associated with adverse neurodevelopmental outcomes across the life span. Recent registry-based studies suggest that preterm birth is associated with decreased wealth in adulthood, but the mediating mechanisms are unknown. This study investigated whether the relationship between preterm birth and low adult wealth is mediated by poor academic abilities and educational qualifications. Participants were members of two British population-based birth cohorts born in 1958 and 1970, respectively. Results showed that preterm birth was associated with decreased wealth at 42 years of age. This association was mediated by decreased intelligence, reading, and, in particular, mathematics attainment in middle childhood, as well as decreased educational qualifications in young adulthood. Findings were similar in both cohorts, which suggests that these mechanisms may be time invariant. Special educational support in childhood may prevent preterm children from becoming less wealthy as adults. © The Author(s) 2015.

Outcomes following implementation of a pediatric procedural sedation guide for referral to general anesthesia for magnetic resonance imaging studies.

PubMed

Grunwell, Jocelyn R; Marupudi, Neelima K; Gupta, Rohan V; Travers, Curtis D; McCracken, Courtney E; Williamson, Julie L; Stockwell, Jana A; Fortenberry, James D; Couloures, Kevin; Cravero, Joseph; Kamat, Pradip P

2016-06-01

Guidelines for referral of children to general anesthesia (GA) to complete MRI studies are lacking. We devised a pediatric procedural sedation guide to determine whether a pediatric procedural sedation guide would decrease serious adverse events and decrease failed sedations requiring rescheduling with GA. We constructed a consensus-based sedation guide by combining a retrospective review of reasons for referral of children to GA (n = 221) with published risk factors associated with the inability to complete the MRI study with sedation. An interrupted time series analysis of 11 530 local sedation records from the Pediatric Sedation Research Consortium between July 2008 and March 2013, adjusted for case-mix differences in the pre- and postsedation guide cohorts, evaluated whether a sedation guide resulted in decreased severe adverse events (SAE) and failed sedation rates. A significant increase in referrals to GA following implementation of a sedation guide occurred (P < 0.001), and fewer children with an ASA-PS class ≥III were sedated using procedural sedation (P < 0.001). There was no decrease in SAE (P = 0.874) or in SAE plus airway obstruction with concurrent hypoxia (P = 0.435). There was no change in the percentage of failed sedations (P = 0.169). More studies are needed to determine the impact of a sedation guide on pediatric procedural sedation services. © 2016 John Wiley & Sons Ltd.

Forecasting the relative influence of environmental and anthropogenic stressors on polar bears

USGS Publications Warehouse

Atwood, Todd C.; Marcot, Bruce G.; Douglas, David C.; Amstrup, Steven C.; Rode, Karyn D.; Durner, George M.; Bromaghin, Jeffrey F.

2016-01-01

Effective conservation planning requires understanding and ranking threats to wildlife populations. We developed a Bayesian network model to evaluate the relative influence of environmental and anthropogenic stressors, and their mitigation, on the persistence of polar bears (Ursus maritimus). Overall sea ice conditions, affected by rising global temperatures, were the most influential determinant of population outcomes. Accordingly, unabated rise in atmospheric greenhouse gas (GHG) concentrations was the dominant influence leading to worsened population outcomes, with polar bears in three of four ecoregions reaching a dominant probability of decreased or greatly decreased by the latter part of this century. Stabilization of atmospheric GHG concentrations by mid-century delayed the greatly reduced state by ≈25 yr in two ecoregions. Prompt and aggressive mitigation of emissions reduced the probability of any regional population becoming greatly reduced by up to 25%. Marine prey availability, linked closely to sea ice trend, had slightly less influence on outcome state than sea ice availability itself. Reduced mortality from hunting and defense of life and property interactions resulted in modest declines in the probability of a decreased or greatly decreased population outcome. Minimizing other stressors such as trans-Arctic shipping, oil and gas exploration, and contaminants had a negligible effect on polar bear outcomes, although the model was not well-informed with respect to the potential influence of these stressors. Adverse consequences of loss of sea ice habitat became more pronounced as the summer ice-free period lengthened beyond four months, which could occur in most of the Arctic basin after mid-century if GHG emissions are not promptly reduced. Long-term conservation of polar bears would be best supported by holding global mean temperature to ≤ 2°C above preindustrial levels. Until further sea ice loss is stopped, management of other stressors may serve to slow the transition of populations to progressively worsened outcomes, and improve the prospects for their long-term persistence.

Long-term outcome of thalamic deep brain stimulation in two patients with Tourette syndrome.

PubMed

Ackermans, Linda; Duits, Annelien; Temel, Yasin; Winogrodzka, Ania; Peeters, Frenk; Beuls, Emile A M; Visser-Vandewalle, Veerle

2010-10-01

Thalamic deep brain stimulation for intractable Tourette Syndrome was introduced in 1999 by Vandewalle et al. In this follow-up study, the authors report on the long-term (6 and 10 years) outcome in terms of tic reduction, cognition, mood and side effects of medial thalamic deep brain stimulation in two previously described Tourette patients. The authors compared the outcome of two patients at 6 and 10 years after surgery with their preoperative status and after 8 months and 5 years of treatment, respectively. Standardised video recordings were scored by three independent investigators. Both patients underwent (neuro)psychological assessment at all time points of follow-up. Tic improvement observed at 5 years in patient 1 (90.1%) was maintained at 10 years (92.6%). In patient 2, the tic improvement at 8 months (82%) was slightly decreased at 6 years (78%). During follow-up, case 1 revealed no changes in cognition, but case 2 showed a decrease in verbal fluency and learning which was in line with his subjective reports. Case 2 showed a slight decrease in depression, but overall psychopathology was still high at 6 years after surgery with an increase in anger and aggression together with difficulties in social adaptation. Besides temporary hardware-related complications, no distressing adverse effects were observed. Bilateral thalamic stimulation may provide sustained tic benefit after at least 6 years, but to maximise overall outcome, attention is needed for postoperative psychosocial adaptation, already prior to surgery.

Becoming tobacco-free: Changes in staff and patient attitudes and incident reports in a large academic mental health and addictions hospital.

PubMed

Riad-Allen, Lilian; Dermody, Sarah Siodmok; Herman, Yarissa; Bellissimo, Kim; Selby, Peter; George, Tony Peter

2017-03-01

Complete tobacco bans in mental health facilities are thought to have the potential for adverse consequences. We evaluated staff and patient attitudes and adverse events associated with implementing Canada's largest, multi-site academic psychiatric hospital tobacco ban. A total of 1,173 staff and 422 patients completed an anonymous attitudes survey at prior to implementation (baseline), and 4-6 months and 10-12 months post-implementation. The tobacco-free initiative was implemented in a phased approach, allowing the prospective measurement of changes in attitudes and adverse outcomes such as agitation over a 1-year period. We observed positive changes in staff and patient attitudes toward the tobacco-free policy for both staff and patients. Moreover, there was also a statistically significant decrease in patient agitation F (2, 99) = 3.25, p = .04, but no change F (2, 21) = 1.09, p = .35 in fire-related incidents. We observed positive changes in staff and patients attitudes and significant decrease in patient agitation during the first year of this tobacco-free hospital initiative. During the first year of this tobacco-free psychiatric hospital policy, implementation of a tobacco-free environment in a large mental health and addictions setting was feasible and perceived as desirable by the majority of staff and patients surveyed and a decrease in incidents related to patient agitation was also observed. Further well-controlled studies with longer study durations are warranted. (Am J Addict 2017;26:183-191). © 2017 American Academy of Addiction Psychiatry.

Becoming tobacco-free: Changes in staff and patient attitudes and incident reports in a large academic mental health and addictions hospital

PubMed Central

Riad-Allen, Lilian; Dermody, Sarah S.; Herman, Yarissa; Bellissimo, Kim; Selby, Peter; George, Tony P.

2017-01-01

Background and Objective Complete tobacco bans in mental health facilities are thought to have the potential for adverse consequences. We evaluated staff and patient attitudes and adverse events associated with implementing Canada's largest, multi-site academic psychiatric hospital tobacco ban. Methods A total of 1,173 staff and 422 patients completed an anonymous attitudes survey at prior to implementation (baseline), and 4-6 months and 10-12 months post-implementation. The tobacco-free initiative was implemented in a phased approach, allowing the prospective measurement of changes in attitudes and adverse outcomes such as agitation over a 1-year period. Results We observed positive changes in staff and patient attitudes towards the tobacco-free policy for both staff and patients. Moreover, there was also a statistically significant decrease in patient agitation F (2,99) = 3.25, p=0.04, but no change F (2, 21) = 1.09, p=0.35 in fire-related incidents. Discussion and Conclusions We observed positive changes in staff and patients attitudes and significant decrease in patient agitation during the first year of this tobacco-free hospital initiative. Scientific Significance During the first year of this tobacco-free psychiatric hospital policy, implementation of a tobacco-free environment in a large mental health and addictions setting was feasible and perceived as desirable by the majority of staff and patients surveyed and a decrease in incidents related to patient agitation was also observed. Further well-controlled studies with longer study durations are warranted. PMID:28211960

The adverse health effects of chronic cannabis use.

PubMed

Hall, Wayne; Degenhardt, Louisa

2014-01-01

This paper summarizes the most probable of the adverse health effects of regular cannabis use sustained over years, as indicated by epidemiological studies that have established an association between cannabis use and adverse outcomes; ruled out reverse causation; and controlled for plausible alternative explanations. We have also focused on adverse outcomes for which there is good evidence of biological plausibility. The focus is on those adverse health effects of greatest potential public health significance--those that are most likely to occur and to affect a substantial proportion of regular cannabis users. These most probable adverse effects of regular use include a dependence syndrome, impaired respiratory function, cardiovascular disease, adverse effects on adolescent psychosocial development and mental health, and residual cognitive impairment. Copyright © 2013 John Wiley & Sons, Ltd.

Perinatal outcomes of immigrant women of Turkish, Middle Eastern and North African origin in Berlin, Germany: a comparison of two time periods.

PubMed

Spallek, Jacob; Lehnhardt, Jessica; Reeske, Anna; Razum, Oliver; David, Matthias

2014-03-01

Publications based on data from perinatal health registries reported worse perinatal health outcomes among women of Turkish origin. The aim of this study was to compare the perinatal outcomes of women of German and Turkish origin in Berlin in two time periods and to analyze if the situation among the women of Turkish origin has improved over time. Datasets of all singleton deliveries from Berlin hospitals for the time periods 1993-1997 (n = 144,600) and 2003-2007 (n = 147,559) were used. Incidence rates resp. prevalences of perinatal health outcomes were computed for women of German and a group of immigrant women mostly of Turkish origin stratified for 'parity' and 'having a partner'. Logistic regression models were computed to test for a change in the odds for adverse perinatal outcomes over time. The chances for adverse perinatal outcomes were decreasing in the later time period for most measures. For stillbirth, preterm birth and congenital malformations, no differences between women of Turkish and German origin could be found. Differences exist in the utilization of perinatal health care and in the risk for anemia. Among women of Turkish origin, the chance for being anemic is even higher in 2003-2007 compared to 1993-1997. The perinatal health measures of women of Turkish origin have improved over time. The lower utilization rates of antenatal health care could be the expression of barriers to access the health care for pregnant women with migration background as offered in Germany. A risk group which needs a special focus by health care providers are women without a partner, irrespective of their origin.

The effect of statins on influenza-like illness morbidity and mortality.

PubMed

Brassard, Paul; Wu, Jennifer W; Ernst, Pierre; Dell'Aniello, Sophie; Smiechowski, Brielan; Suissa, Samy

2017-01-01

The effect of statins on cytokine-mediated inflammatory responses may impact on the prognosis of influenza. We assessed whether statin use decreases the incidence of adverse influenza-related outcomes. Additionally, we used a new-user study design to minimize healthy user bias. We further examined the possibility of non-causal associations by using unrelated outcomes. We used the UK Clinical Practice Research Datalink to identify all patients aged 30 or older diagnosed with influenza-like illness during 1997-2010. Statin users were compared with propensity score-matched patients not receiving statins. The outcome was hospitalization for influenza or pneumonia or death in the 30 days following influenza diagnosis. Logistic regression estimated cumulative incidence ratios. The study cohort included 5181 statin users matched to 5181 non-users. The 30-day incidence of hospitalization or death was 3.5% in statin users and 5.2% in non-users, resulting in a 27% lower incidence with statin use (cumulative incidence ratio: 0.73, 95%CI: 0.59-0.89). New statin users were less protected against our composite outcome. The effect of statins was less pronounced among those with respiratory and cardiac disease. Statin use was shown to be associated with a non-statistically significant risk reduction of motor vehicle accident and burns. The attenuation of the effect of statins with the new-user design, supporting evidence from the assessment of effect modification, and additional sub-analyses evaluating the effect of statins on non-related outcomes suggest that the beneficial effect of statins on influenza-related adverse outcomes may be explained by a healthy user bias. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Paternal Urinary Concentrations of Parabens and Other Phenols in Relation to Reproductive Outcomes among Couples from a Fertility Clinic

PubMed Central

Dodge, Laura E.; Williams, Paige L.; Williams, Michelle A.; Missmer, Stacey A.; Toth, Thomas L.; Calafat, Antonia M.

2015-01-01

Background Human exposure to phenols, including bisphenol A and parabens, is widespread. Evidence suggests that paternal exposure to environmental chemicals may adversely affect reproductive outcomes. Objectives We evaluated associations of paternal phenol urinary concentrations with fertilization rate, embryo quality, implantation, and live birth. Methods Male–female couples who underwent in vitro fertilization (IVF) and/or intrauterine insemination (IUI) cycles in a prospective study of environmental determinants of fertility and pregnancy outcomes were included. The geometric mean of males’ specific gravity–adjusted urinary phenol concentrations measured before females’ cycle was quantified. Associations between male urinary phenol concentrations and fertilization rate, embryo quality, implantation, and live birth were investigated using generalized linear mixed models to account for multiple cycles per couple. Results Couples (n = 218) underwent 195 IUI and 211 IVF cycles. Paternal phenol concentrations were not associated with fertilization or live birth following IVF. In adjusted models, compared with the lowest quartile of methyl paraben, paternal concentrations in the second quartile were associated with decreased odds of live birth following IUI (adjusted odds ratio = 0.19; 95% CI: 0.04, 0.82). Conclusions To our knowledge, these are some of the first data on the association of paternal urinary phenol concentrations with reproduction and pregnancy outcomes. Although these results do not preclude possible adverse effects of paternal paraben exposures on such outcomes, given the modest sample size, further understanding could result from confirmation using a larger and more diverse population. Citation Dodge LE, Williams PL, Williams MA, Missmer SA, Toth TL, Calafat AM, Hauser R. 2015. Paternal urinary concentrations of parabens and other phenols in relation to reproductive outcomes among couples from a fertility clinic. Environ Health Perspect 123:665–671; http://dx.doi.org/10.1289/ehp.1408605 PMID:25767892

Interactions Between Secondhand Smoke and Genes That Affect Cystic Fibrosis Lung Disease

PubMed Central

Collaco, J. Michael; Vanscoy, Lori; Bremer, Lindsay; McDougal, Kathryn; Blackman, Scott M.; Bowers, Amanda; Naughton, Kathleen; Jennings, Jacky; Ellen, Jonathan; Cutting, Garry R.

2011-01-01

Context Disease variation can be substantial even in conditions with a single gene etiology such as cystic fibrosis (CF). Simultaneously studying the effects of genes and environment may provide insight into the causes of variation. Objective To determine whether secondhand smoke exposure is associated with lung function and other outcomes in individuals with CF, whether socioeconomic status affects the relationship between secondhand smoke exposure and lung disease severity, and whether specific gene-environment interactions influence the effect of secondhand smoke exposure on lung function. Design, Setting, and Participants Retrospective assessment of lung function, stratified by environmental and genetic factors. Data were collected by the US Cystic Fibrosis Twin and Sibling Study with missing data supplemented by the Cystic Fibrosis Foundation Data Registry. All participants were diagnosed with CF, were recruited between October 2000 and October 2006, and were primarily from the United States. Main Outcome Measures Disease-specific cross-sectional and longitudinal measures of lung function. Results Of 812 participants with data on secondhand smoke in the home, 188 (23.2%) were exposed. Of 780 participants with data on active maternal smoking during gestation, 129 (16.5%) were exposed. Secondhand smoke exposure in the home was associated with significantly lower cross-sectional (9.8 percentile point decrease; P<.001) and longitudinal lung function (6.1 percentile point decrease; P=.007) compared with those not exposed. Regression analysis demonstrated that socioeconomic status did not confound the adverse effect of secondhand smoke exposure on lung function. Interaction between gene variants and secondhand smoke exposure resulted in significant percentile point decreases in lung function, namely in CFTR non-ΔF508 homozygotes (12.8 percentile point decrease; P=.001), TGFβ1-509 TT homozygotes (22.7 percentile point decrease; P=.006), and TGFβ1 codon 10 CC homozygotes (20.3 percentile point decrease; P=.005). Conclusions Any exposure to secondhand smoke adversely affects both cross-sectional and longitudinal measures of lung function in individuals with CF. Variations in the gene that causes CF (CFTR) and a CF-modifier gene (TGFβ1) amplify the negative effects of secondhand smoke exposure. PMID:18230779

21 CFR 803.42 - If I am an importer, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false If I am an importer, what information must I submit in my individual adverse event reports? 803.42 Section 803.42 Food and Drugs FOOD AND DRUG...; (2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is...

21 CFR 803.42 - If I am an importer, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false If I am an importer, what information must I submit in my individual adverse event reports? 803.42 Section 803.42 Food and Drugs FOOD AND DRUG...; (2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is...

Application of the Aggregate Exposure Pathway and Adverse Outcome Pathway frameworks to advance cumulative risk assessment by integrating human health and ecological endpoints

EPA Science Inventory

Evaluating risk of adverse outcomes from chemical exposure is essential for understanding the impacts of environmental contaminants. While human health outcomes are of primary concern and are often the focus of risk assessments, important non-human species are also exposed to co...

A workflow to investigate exposure and pharmacokinetic influences on high-throughput in vitro chemical screening based on adverse outcome pathways, OpenTox USA 2015 Poster

EPA Science Inventory

Adverse outcome pathways (AOP) link known population outcomes to a molecular initiating event (MIE) that can be quantified using high-throughput in vitro methods. Practical application of AOPs in chemical-specific risk assessment requires consideration of exposure and absorption,...

Cortisol Reactivity to Social Stress as a Mediator of Early Adversity on Risk and Adaptive Outcomes

ERIC Educational Resources Information Center

Conradt, Elisabeth; Abar, Beau; Lester, Barry M.; LaGasse, Linda L.; Shankaran, Seetha; Bada, Henrietta; Bauer, Charles R.; Whitaker, Toni M.; Hammond, Jane A.

2014-01-01

Children chronically exposed to stress early in life are at increased risk for maladaptive outcomes, though the physiological mechanisms driving these effects are unknown. Cortisol reactivity was tested as a mediator of the relation between prenatal substance exposure and/or early adversity on adaptive and maladaptive outcomes. Data were drawn…

Association of brain injury and neonatal cytokine response during therapeutic hypothermia in newborns with hypoxic-ischemic encephalopathy.

PubMed

Orrock, Janet E; Panchapakesan, Karuna; Vezina, Gilbert; Chang, Taeun; Harris, Kari; Wang, Yunfei; Knoblach, Susan; Massaro, An N

2016-05-01

Cytokines have been proposed as mediators of neonatal brain injury via neuroinflammatory pathways triggered by hypoxia-ischemia. Limited data are available on cytokine profiles in larger cohorts of newborns with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia (TH). Serum cytokines interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-13, tumor necrosis factor-α, and interferon-γ were measured in newborns with HIE at 24 and 72 h of TH. Differences between infants with favorable (survivors with mild/no magnetic resonance imaging (MRI) injury) vs. adverse outcome (death or moderate/severe MRI injury) were compared using mixed models to adjust for covariates. Data from 36 term newborns with HIE (favorable outcome: n = 20, adverse outcome: n = 16) were evaluated. Cytokines IL-1β, IL-2, IL-6, IL-8, IL-10, and IL-13 were elevated in the adverse relative to favorable outcome group at 24 h. IL-6 remained significantly elevated in the adverse outcome group at 72 h. IL-6 and IL-10 remained significantly associated with outcome group after controlling for covariates. Inflammatory cytokines are elevated in HIE newborns with brain injury by MRI. In particular, IL-6 and IL-10 were associated with adverse outcomes after controlling for baseline characteristics and severity of presentation. These data suggest that cytokine response may identify infants in need of additional neuroprotective interventions.

Gestational diabetes mellitus and pregnancy outcomes among Chinese and South Asian women in Canada.

PubMed

Mukerji, Geetha; Chiu, Maria; Shah, Baiju R

2013-02-01

To determine the association between Chinese or South Asian ethnicity and adverse neonatal and maternal outcomes for women with gestational diabetes compared to the general population. A cohort study was conducted using population-based health care databases in Ontario, Canada. All 35,577 women aged 15-49 with gestational diabetes who had live births between April 2002 and March 2011 were identified. Their delivery hospitalization records and the birth records of their neonates were examined to identify adverse neonatal outcomes and adverse maternal outcomes. Compared to infants of mothers from the general population (55.5%), infants of Chinese mothers had a lower risk of an adverse outcome at delivery (42.9%, adjusted odds ratio 0.63, 95% confidence interval 0.58-0.68), whereas infants of South Asian mothers had a higher risk (58.9%, adjusted odds ratio 1.15, 95% confidence interval 1.07-1.23). Chinese women also had a lower risk of adverse maternal outcomes (32.4%, adjusted odds ratio 0.58, 95% confidence interval 0.54-0.63) compared to general population women (41.2%), whereas the risk for South Asian women was not different (39.4%, adjusted odds ratio 0.94, 95% confidence interval 0.88-1.02) from that of general population women. The risk of complications of gestational diabetes differs significantly between Chinese and South Asian patients and the general population in Ontario. Tailored interventions for gestational diabetes management may be required to improve pregnancy outcomes in high-risk ethnic groups.

Defining catastrophic costs and comparing their importance for adverse tuberculosis outcome with multi-drug resistance: a prospective cohort study, Peru.

PubMed

Wingfield, Tom; Boccia, Delia; Tovar, Marco; Gavino, Arquímedes; Zevallos, Karine; Montoya, Rosario; Lönnroth, Knut; Evans, Carlton A

2014-07-01

Even when tuberculosis (TB) treatment is free, hidden costs incurred by patients and their households (TB-affected households) may worsen poverty and health. Extreme TB-associated costs have been termed "catastrophic" but are poorly defined. We studied TB-affected households' hidden costs and their association with adverse TB outcome to create a clinically relevant definition of catastrophic costs. From 26 October 2002 to 30 November 2009, TB patients (n = 876, 11% with multi-drug-resistant [MDR] TB) and healthy controls (n = 487) were recruited to a prospective cohort study in shantytowns in Lima, Peru. Patients were interviewed prior to and every 2-4 wk throughout treatment, recording direct (household expenses) and indirect (lost income) TB-related costs. Costs were expressed as a proportion of the household's annual income. In poorer households, costs were lower but constituted a higher proportion of the household's annual income: 27% (95% CI = 20%-43%) in the least-poor houses versus 48% (95% CI = 36%-50%) in the poorest. Adverse TB outcome was defined as death, treatment abandonment or treatment failure during therapy, or recurrence within 2 y. 23% (166/725) of patients with a defined treatment outcome had an adverse outcome. Total costs ≥20% of household annual income was defined as catastrophic because this threshold was most strongly associated with adverse TB outcome. Catastrophic costs were incurred by 345 households (39%). Having MDR TB was associated with a higher likelihood of incurring catastrophic costs (54% [95% CI = 43%-61%] versus 38% [95% CI = 34%-41%], p<0.003). Adverse outcome was independently associated with MDR TB (odds ratio [OR] = 8.4 [95% CI = 4.7-15], p<0.001), previous TB (OR = 2.1 [95% CI = 1.3-3.5], p = 0.005), days too unwell to work pre-treatment (OR = 1.01 [95% CI = 1.00-1.01], p = 0.02), and catastrophic costs (OR = 1.7 [95% CI = 1.1-2.6], p = 0.01). The adjusted population attributable fraction of adverse outcomes explained by catastrophic costs was 18% (95% CI = 6.9%-28%), similar to that of MDR TB (20% [95% CI = 14%-25%]). Sensitivity analyses demonstrated that existing catastrophic costs thresholds (≥10% or ≥15% of household annual income) were not associated with adverse outcome in our setting. Study limitations included not measuring certain "dis-saving" variables (including selling household items) and gathering only 6 mo of costs-specific follow-up data for MDR TB patients. Despite free TB care, having TB disease was expensive for impoverished TB patients in Peru. Incurring higher relative costs was associated with adverse TB outcome. The population attributable fraction indicated that catastrophic costs and MDR TB were associated with similar proportions of adverse outcomes. Thus TB is a socioeconomic as well as infectious problem, and TB control interventions should address both the economic and clinical aspects of this disease. Please see later in the article for the Editors' Summary.

Residential Proximity to Environmental Hazards and Adverse Health Outcomes

PubMed Central

Maantay, Juliana A.; Chakraborty, Jayajit

2011-01-01

How living near environmental hazards contributes to poorer health and disproportionate health outcomes is an ongoing concern. We conducted a substantive review and critique of the literature regarding residential proximity to environmental hazards and adverse pregnancy outcomes, childhood cancer, cardiovascular and respiratory illnesses, end-stage renal disease, and diabetes. Several studies have found that living near hazardous wastes sites, industrial sites, cropland with pesticide applications, highly trafficked roads, nuclear power plants, and gas stations or repair shops is related to an increased risk of adverse health outcomes. Government agencies should consider these findings in establishing rules and permitting and enforcement procedures to reduce pollution from environmentally burdensome facilities and land uses. PMID:22028451

Outcome of ventilated infants born at term without major congenital abnormalities.

PubMed

Ramadan, Ghada; Paul, Nicola; Morton, Margaret; Peacock, Janet L; Greenough, Anne

2012-02-01

The longer-term outcome of term-born infants without congenital anomalies requiring ventilation in the first 24 h after birth has rarely been reported. Our aims were to determine the mortality and long-term morbidity of such infants and identify risk factors for adverse outcome. The outcomes of 43 of 45 infants born at term consecutively requiring mechanical ventilation were reviewed. The infants had: meconium aspiration syndrome (n = 11), hypoxic ischaemic encephalopathy (HIE) (n = 11), respiratory depression (n = 12), sepsis (n = 5), persistent pulmonary hypertension of the newborn (n = 3) and middle cerebral artery infarction (n = 1). Eleven infants developed seizures (26%), 13 (30%) had abnormal electroencephalograms and 11 (26%) had abnormal MRI scans; 26% had an adverse outcome: six died, and five had severe neurodisability at 2 years. The infants with congenital toxoplasmosis and a middle cerebral artery infarction were excluded from the prediction analysis. In the remaining 41 patients, requirement for anticonvulsants (relative risk, RR = 4.44, 95% CI = 1.48 to 12.70; p = 0.014) and prolonged ventilation (longer than 3 days) (RR 4.83, 95% CI 1.51 to 15.64) predicted adverse outcome. Infants with HIE had an increased risk of adverse outcome (relative risk 5.45, 95% CI 1.01 to 33.85), but an adverse outcome occurred in infants with other diagnoses. Mortality and neurodisability at follow-up were common in infants born at term without major congenital anomalies who required mechanical ventilation in the first 24 h after birth, particularly in those who developed seizures requiring treatment and prolonged ventilation.

Healthcare-Associated Meningitis or Ventriculitis in Older Adults.

PubMed

Srihawan, Chanunya; Habib, Onaizah; Salazar, Lucrecia; Hasbun, Rodrigo

2017-12-01

Healthcare-associated meningitis or ventriculitis (HCAMV) is a serious and life-threatening complication of invasive neurosurgical procedures or penetrating head trauma. Older adults are at higher risk of adverse outcomes in community-acquired meningitis but studies of HCAMV are lacking. Therefore, we perform the study to define the differences in clinical outcomes between older and younger adults with HCAMV. Retrospective study. A large tertiary care hospital in Houston, Texas, from July 2003 to November 2014. Adults with a diagnosis of HCAMV (N = 160) aged ≥65 (n = 35), aged 18-64 (n = 125). Demographic characteristics, clinical presentation, laboratory results, treatments, and outcomes (Glasgow Outcome Scale). Older adults had more comorbidities and CSF abnormalities [pleocytosis, high cerebrospinal fluid (CSF) protein, low CSF glucose) and were more likely to have altered mental status than younger adults (P < .05). An adverse clinical outcome was seen in 142 participants (89%) (death (n = 18, 11%), persistent vegetative state (n = 26, 16%), severe disability (n = 68, 43%), moderate disability (n = 30, 19%). There was no difference in adverse outcomes between older (97%) and younger (86%) adults (P = .13). On logistic regression analysis, abnormal neurological examination (adjusted odds ratio (aOR) = 7.13, 95% confidence interval (CI) = 2.15-23.63, P = .001) and mechanical ventilation (aOR = 11.03, 95% CI = 1.35-90.51, P = .02) were associated with adverse clinical outcomes. Older adults with HCAMV have more comorbidities and CSF abnormalities and are more likely to have altered mental status than younger adults but have similar high rates of adverse clinical outcomes. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Prevalence of abortion and adverse pregnancy outcomes among working women in Korea: A cross-sectional study

PubMed Central

Park, Chulyong; Kang, Mo-Yeol; Kim, Dohyung; Park, Jaechan; Eom, Huisu

2017-01-01

Objectives To investigate incidence and distribution of major adverse reproductive health problems related to various kinds of industries in Korea and to compare risks for major reproductive outcomes to assess maternal health in working and non-working women. Methods We requested claim data from the Korean National Health Insurance. We defined reference groups as (1) non-working women and (2) workers in the education field. Women working in each industry were compared with reference groups regarding rates of miscarriage, threatened abortion, preterm labor, and intrauterine growth restriction. Logistic regression was used for multivariate analysis, and age and income adjustment was performed. Results The percentages of all adverse obstetric outcomes were higher in working women than in non-working women. Working women had higher and statistically significant adjusted odds ratios (ORs) for miscarriage in 18 of the 21 industries. The age and income-adjusted OR for miscarriage for all working women was 1.26 (95% confidence interval, 1.23–1.28). Business facilities management and business support services, manufacturing, human health and social work activities, wholesale and retail trade, and professional, scientific, and technical activities were major industries with higher adjusted ORs for adverse obstetric outcomes. Conclusions We confirmed that compared to non-working women, working women have a higher risk for adverse pregnancy outcomes. Thus, adverse pregnancy outcomes such as threatened abortion, preterm labor, and intrauterine growth restriction may be associated with working status. This exploratory study identified several industries where in-depth studies are required in future to improve occupational safety in women of reproductive age. PMID:28850585

Prevalence of abortion and adverse pregnancy outcomes among working women in Korea: A cross-sectional study.

PubMed

Park, Chulyong; Kang, Mo-Yeol; Kim, Dohyung; Park, Jaechan; Eom, Huisu; Kim, Eun-A

2017-01-01

To investigate incidence and distribution of major adverse reproductive health problems related to various kinds of industries in Korea and to compare risks for major reproductive outcomes to assess maternal health in working and non-working women. We requested claim data from the Korean National Health Insurance. We defined reference groups as (1) non-working women and (2) workers in the education field. Women working in each industry were compared with reference groups regarding rates of miscarriage, threatened abortion, preterm labor, and intrauterine growth restriction. Logistic regression was used for multivariate analysis, and age and income adjustment was performed. The percentages of all adverse obstetric outcomes were higher in working women than in non-working women. Working women had higher and statistically significant adjusted odds ratios (ORs) for miscarriage in 18 of the 21 industries. The age and income-adjusted OR for miscarriage for all working women was 1.26 (95% confidence interval, 1.23-1.28). Business facilities management and business support services, manufacturing, human health and social work activities, wholesale and retail trade, and professional, scientific, and technical activities were major industries with higher adjusted ORs for adverse obstetric outcomes. We confirmed that compared to non-working women, working women have a higher risk for adverse pregnancy outcomes. Thus, adverse pregnancy outcomes such as threatened abortion, preterm labor, and intrauterine growth restriction may be associated with working status. This exploratory study identified several industries where in-depth studies are required in future to improve occupational safety in women of reproductive age.

The Association Between Adverse Child Health, Psychological, Educational and Social Outcomes, and Nondependent Parental Substance: A Rapid Evidence Assessment.

PubMed

McGovern, Ruth; Gilvarry, Eilish; Addison, Michelle; Alderson, Hayley; Geijer-Simpson, Emma; Lingam, Raghu; Smart, Debbie; Kaner, Eileen

2018-01-01

Between 5% and 30% of children in high-income countries live with a substance misusing parent, the majority of which is below dependent levels. However, little is understood about the impact of nondependent parental substance misuse upon children. We searched the international literature using rigorous systematic methods to identify studies examining parental substance misuse and adverse outcomes in children. The inclusion criteria were cross-sectional, longitudinal, case-control, and cohort studies; of children aged 0-18 years whose parents are high-risk substance misusers; reporting on their health, psychological, substance use, educational, and social outcomes. We identified 36 papers (from 33 unique studies), most of which were assessed as being of medium to high methodological quality ( N= 28). Parental nondependent substance misuse was found to be associated with adversity in children, with strong evidence of an association with externalizing difficulties ( N = 7 papers, all finding an association) and substance use ( N = 23 papers, all finding an association) in adolescents and some evidence of adverse health outcomes in early childhood ( N = 6/8 papers finding an association). There is less evidence of an association between parental substance misuse and adverse educational and social outcomes. The body of evidence was largest for parental alcohol misuse, with research examining the impact of parental illicit drug use being limited. Methodological limitations restrict our ability to make causal inference. Nonetheless, the prevalence of adverse outcomes in children whose parents are nondependent substance misusers highlights the need for practitioners to intervene with this population before a parent has developed substance dependency.

Adverse perinatal outcomes associated with moderate or severe maternal anaemia based on parity in Finland during 2006-10.

PubMed

Räisänen, Sari; Kancherla, Vijaya; Gissler, Mika; Kramer, Michael R; Heinonen, Seppo

2014-09-01

Anaemia during pregnancy is an important public health problem. We investigated whether the association between maternal anaemia during pregnancy and adverse perinatal outcomes differed between nulliparous and multiparous women. A retrospective population-based cohort study was conducted using data on all singleton births (n = 290 662) recorded in the Finnish Medical Birth Register during 2006-10. Maternal anaemia was defined as a maternal haemoglobin level of <100 g/L). Adverse perinatal outcomes that were examined included preterm delivery (<37 weeks), small-for-gestational age (SGA, <2 standard deviation), admission to neonatal intensive care, stillbirth, early neonatal death, and major congenital anomalies. An association between anaemia and adverse outcomes was assessed by logistic regression analysis. The prevalence of anaemia during pregnancy was 2.5% among nulliparous women and 2.3% among multiparous women. Among nulliparous women, anaemia was not associated with adverse perinatal outcomes. Among multiparous women, anaemia was associated with preterm delivery (adjusted odds ratio [aOR] 1.32, [95% CI 1.14, 1.53]), SGA (aOR 1.27, [95% CI 1.04, 1.55]), and admission to neonatal intensive care (aOR 1.23, [95% CI 1.10, 1.38]); there was a trend towards increased odds of major congenital anomalies (aOR 1.15, [95% CI 0.99, 1.34]). These data underscore that maternal anaemia is associated with several adverse perinatal outcomes. This association was, however, confined to multiparous women. Future research should explore in detail the timing of anaemia in these associations. © 2014 John Wiley & Sons Ltd.

Developing and applying the adverse outcome pathway concept for understanding and predicting neurotoxicity

PubMed Central

Bal-Price, Anna; Lein, Pamela J.; Keil, Kimberly P.; Sethi, Sunjay; Shafer, Timothy; Barenys, Marta; Fritsche, Ellen; Sachana, Magdalini; Meek, M.E. (Bette)

2016-01-01

The Adverse Outcome Pathway (AOP) concept has recently been proposed to support a paradigm shift in regulatory toxicology testing and risk assessment. This concept is similar to the Mode of Action (MOA), in that it describes a sequence of measurable key events triggered by a molecular initiating event in which a stressor interacts with a biological target. The resulting cascade of key events includes molecular, cellular, structural and functional changes in biological systems, resulting in a measurable adverse outcome. Thereby, an AOP ideally provides information relevant to chemical structure-activity relationships as a basis for predicting effects of structurally similar compounds. AOPs could potentially also form the basis for qualitative and quantitative predictive modeling of the human adverse outcome resulting from molecular initiating or other key events for which higher-throughput testing methods are available or can be developed. A variety of cellular and molecular processes are known to be critical for normal function of the central (CNS) and peripheral nervous systems (PNS). Because of the biological and functional complexity of the CNS and PNS, it has been challenging to establish causative links and quantitative relationships between key events that comprise the pathways leading from chemical exposure to an adverse outcome in the nervous system. Following introduction of the principles of MOA and AOPs, examples of potential or putative adverse outcome pathways specific for developmental or adult neurotoxicity are summarized and aspects of their assessment considered. Their possible application in developing mechanistically informed Integrated Approaches to Testing and Assessment (IATA) is also discussed. PMID:27212452

Microorganisms within Human Follicular Fluid: Effects on IVF

PubMed Central

Pelzer, Elise S.; Allan, John A.; Waterhouse, Mary A.; Ross, Tara; Beagley, Kenneth W.; Knox, Christine L.

2013-01-01

Our previous study reported microorganisms in human follicular fluid. The objective of this study was to test human follicular fluid for the presence of microorganisms and to correlate these findings with the in vitro fertilization (IVF) outcomes. In this study, 263 paired follicular fluids and vaginal swabs were collected from women undergoing IVF cycles, with various causes for infertility, and were cultured to detect microorganisms. The cause of infertility and the IVF outcomes for each woman were correlated with the microorganisms detected within follicular fluid collected at the time of trans-vaginal oocyte retrieval. Microorganisms isolated from follicular fluids were classified as: (1) ‘colonizers’ if microorganisms were detected within the follicular fluid, but not within the vaginal swab (at the time of oocyte retrieval); or (2) ‘contaminants’ if microorganisms detected in the vagina at the time of oocyte retrieval were also detected within the follicular fluid. The presence of Lactobacillus spp. in ovarian follicular fluids was associated with embryo maturation and transfer. This study revealed microorganisms in follicular fluid itself and that the presence of particular microorganisms has an adverse affect on IVF outcomes as seen by an overall decrease in embryo transfer rates and pregnancy rates in both fertile and infertile women, and live birth rates in women with idiopathic infertility. Follicular fluid microorganisms are a potential cause of adverse pregnancy outcomes in IVF in both infertile women and in fertile women with infertile male partners. PMID:23554970

Costs and effects of screening and treating low risk women with a singleton pregnancy for asymptomatic bacteriuria, the ASB study.

PubMed

Kazemier, Brenda M; Schneeberger, Caroline; De Miranda, Esteriek; Van Wassenaer, Aleid; Bossuyt, Patrick M; Vogelvang, Tatjana E; Reijnders, Frans J L; Delemarre, Friso M C; Verhoeven, Corine J M; Oudijk, Martijn A; Van Der Ven, Jeanine A; Kuiper, Petra N; Feiertag, Nicolette; Ott, Alewijn; De Groot, Christianne J M; Mol, Ben Willem J; Geerlings, Suzanne E

2012-06-21

The prevalence of asymptomatic bacteriuria (ASB) in pregnancy is 2-10% and is associated with both maternal and neonatal adverse outcomes as pyelonephritis and preterm delivery. Antibiotic treatment is reported to decrease these adverse outcomes although the existing evidence is of poor quality. We plan a combined screen and treat study in women with a singleton pregnancy. We will screen women between 16 and 22 weeks of gestation for ASB using the urine dipslide technique. The dipslide is considered positive when colony concentration ≥105 colony forming units (CFU)/mL of a single microorganism or two different colonies but one ≥105 CFU/mL is found, or when Group B Streptococcus bacteriuria is found in any colony concentration. Women with a positive dipslide will be randomly allocated to receive nitrofurantoin or placebo 100 mg twice a day for 5 consecutive days (double blind). Primary outcomes of this trial are maternal pyelonephritis and/or preterm delivery before 34 weeks. Secondary outcomes are neonatal and maternal morbidity, neonatal weight, time to delivery, preterm delivery rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal admission days and costs. This trial will provide evidence for the benefit and cost-effectiveness of dipslide screening for ASB among low risk women at 16-22 weeks of pregnancy and subsequent nitrofurantoin treatment. Dutch trial registry: NTR-3068.

Costs and effects of screening and treating low risk women with a singleton pregnancy for asymptomatic bacteriuria, the ASB study

PubMed Central

2012-01-01

Background The prevalence of asymptomatic bacteriuria (ASB) in pregnancy is 2-10% and is associated with both maternal and neonatal adverse outcomes as pyelonephritis and preterm delivery. Antibiotic treatment is reported to decrease these adverse outcomes although the existing evidence is of poor quality. Methods/Design We plan a combined screen and treat study in women with a singleton pregnancy. We will screen women between 16 and 22 weeks of gestation for ASB using the urine dipslide technique. The dipslide is considered positive when colony concentration ≥105 colony forming units (CFU)/mL of a single microorganism or two different colonies but one ≥105 CFU/mL is found, or when Group B Streptococcus bacteriuria is found in any colony concentration. Women with a positive dipslide will be randomly allocated to receive nitrofurantoin or placebo 100 mg twice a day for 5 consecutive days (double blind). Primary outcomes of this trial are maternal pyelonephritis and/or preterm delivery before 34 weeks. Secondary outcomes are neonatal and maternal morbidity, neonatal weight, time to delivery, preterm delivery rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal admission days and costs. Discussion This trial will provide evidence for the benefit and cost-effectiveness of dipslide screening for ASB among low risk women at 16–22 weeks of pregnancy and subsequent nitrofurantoin treatment. Trial registration Dutch trial registry: NTR-3068 PMID:22892110

Folic acid: influence on the outcome of pregnancy.

PubMed

Scholl, T O; Johnson, W G

2000-05-01

The periconceptional use of folic acid-containing supplements reduces the first occurrence, as well as the recurrence, of neural tube defects. Women of populations in which adverse pregnancy outcomes are prevalent often consume diets that contain a low density of vitamins and minerals, including folate. Folate intake may need to be sustained after complete closure of the neural tube to decrease the risk of other poor pregnancy outcomes. A central feature of embryonic and fetal development is widespread cell division; folate is central because of its role in nucleic acid synthesis. During gestation, marginal folate nutriture can impair cellular growth and replication in the fetus or placenta. Folate deficiency can occur because dietary folate intake is low or because the metabolic requirement for folate is increased by a particular genetic defect or defects. During pregnancy, low concentrations of dietary and circulating folate are associated with increased risks of preterm delivery, infant low birth weight, and fetal growth retardation. A metabolic effect of folate deficiency is an elevation of blood homocysteine. Likewise, the presence of maternal homocysteine concentrations have been associated both with increased habitual spontaneous abortion and pregnancy complications (eg, placental abruption and preeclampsia), which increase the risk of poor pregnancy outcome and of decreased birth weight and gestation duration.

Unsatisfactory Glucose Management and Adverse Pregnancy Outcomes of Gestational Diabetes Mellitus in the Real World of Clinical Practice: A Retrospective Study.

PubMed

Feng, Ru; Liu, Lu; Zhang, Yuan-Yuan; Yuan, Zhong-Shang; Gao, Ling; Zuo, Chang-Ting

2018-05-05

Facing the increasing prevalence of gestational diabetes mellitus (GDM), this study aimed to evaluate the management of GDM and its association with adverse pregnancy outcomes. The data of 996 inpatients with GDM who terminated pregnancies in our hospital from January 2011 to December 2015 were collected. Treatments during pregnancy and the last hospital admission before delivery were analyzed. Pregnancy outcomes of the GDM patients were compared with 996 nondiabetic subjects matched by delivery year and gestational age. The association between fasting plasma glucose (FPG) and adverse pregnancy outcomes was examined by logistic regression analyses. The average prevalence of GDM over the 5 years was 4.4% (1330/30,191). Within the GDM patients, 42.8% (426/996) received dietary intervention, whereas 19.1% (190/996) received insulin treatment. Adverse outcomes were more likely to occur in patients with unsatisfactory control of blood glucose such as respiratory distress syndrome (RDS, χ 2 = 13.373, P < 0.01). Elevated FPG was identified as an independent risk factor for premature birth (odds ratio [OR] = 1.460, P < 0.001), neonatal care unit admission (OR = 1.284, P < 0.001), RDS (OR = 1.322, P = 0.001), and stillbirth (OR = 1.427, P < 0.001). Management of GDM in the real world of clinical practice was unsatisfactory, which might have contributed to adverse pregnancy outcomes.

Accelerating Adverse Outcome Pathway Development via Systems Approaches

EPA Science Inventory

The Adverse Outcome Pathway has emerged as an internationally harmonized mechanism for organizing biological information in a chemical agnostic manner. This construct is valuable for interpreting the results from high-throughput toxicity (HTT) assessment by providing a mechanisti...

Adverse outcome pathway (AOP) development: Guiding principles and best practices

EPA Science Inventory

Adverse outcome pathways (AOPs) represent a conceptual framework that can support greater application of mechanistic data in regulatory decision-making. However, in order for the scientific community to collectively address the daunting challenge of describing relevant toxicologi...

Overview of an internationally-harmonized program for adverse outcome pathway development

EPA Science Inventory

Adverse outcome pathways (AOPs) are critical frameworks for organizing knowledge concerning the scientifically-credible predictive linkages between toxicological observations made at molecular and cellular levels (e.g., via molecular screening assays, biomarker responses, or chem...

Adverse Outcome Pathways: From Definition to Application

EPA Science Inventory

A challenge for both human health and ecological toxicologists is the transparent application of mechanistic (e.g., molecular, biochemical, histological) data to risk assessments. The adverse outcome pathway (AOP) is a conceptual framework designed to meet this need. Specifical...

Fetal tissue Doppler imaging in pregnancies complicated with preeclampsia with or without intrauterine growth restriction.

PubMed

Zhou, Qiongjie; Ren, Yunyun; Yan, Yingliu; Chu, Chen; Gui, Yonghao; Li, Xiaotian

2012-11-01

This study's aim was to evaluate the effect of preeclampsia and intrauterine growth restriction (IUGR) on fetal cardiac function, and the relationship of the latter with adverse pregnancy outcomes. We did a cross-sectional study of 132 women with uncomplicated singleton pregnancies, 34 with preeclampsia without IUGR, and 12 with preeclampsia and IUGR. Fetal cardiac structure and function were evaluated using fetal two-dimension ultrasound, pulsed wave Doppler and tissue Doppler imaging (TDI). Data were analyzed by t-tests, ANOVA, Chi-square tests, or Wilcoxon rank-sum test. Compared with the normal pregnancy group, mitral/tricuspid early systolic peak velocity of annulus/late diastolic peak velocity of annulus (Sa) and left ventricular (LV)/right ventricular (RV) early diastolic peak velocity at the annulus (Ea) in TDI decreased in preeclampsia with or without IUGR (P < 0.05). LV/RV Ea underwent a gestational decrease in preeclampsia with or without IUGR (P < 0.05). The changes in mitral/tricuspid Sa and LV Sa associated with preeclampsia were even more pronounced with preterm delivery at less than 34 gestational weeks and stillbirth (P < 0.05). Intrauterine growth restriction influences fetal cardiac function in the presence of preeclampsia, and TDI may be a sensitive and preferable method to detect such changes. Fetal LV/RV Ea is a potential marker for early fetal cardiac diastolic impairment, and mitral/tricuspid Sa and LV Sa may be predictors for adverse pregnancy outcomes. © 2012 John Wiley & Sons, Ltd.

Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial.

PubMed

Micks, Elizabeth A; Edelman, Alison B; Renner, Regina-Maria; Fu, Rongwei; Lambert, William E; Bednarek, Paula H; Nichols, Mark D; Beckley, Ethan H; Jensen, Jeffrey T

2012-11-01

Although hydrocodone-acetaminophen is commonly used for pain control in first-trimester abortion, the efficacy of oral opioids for decreasing pain has not been established. Our objective was to estimate the effect of hydrocodone-acetaminophen on patient pain perception during first-trimester surgical abortion. We conducted a randomized, double-blinded, placebo-controlled trial. Patients (before 11 weeks of gestation) received standard premedication (ibuprofen and lorazepam) and a paracervical block with the addition of 10 mg hydrocodone and 650 mg acetaminophen or placebo 45-90 minutes before surgical abortion. A sample size of 120 was calculated to provide 80% power to show a 15-mm difference (α=0.05) in the primary outcome of pain with uterine aspiration (100-mm visual analog scale). Secondary outcomes were pain at additional time points, satisfaction, side effects, adverse events, and need for additional pain medications. There were no significant differences in demographics or baseline pain between groups. There were no differences in pain scores between patients receiving hydrocodone-acetaminophen compared with placebo during uterine aspiration (65.7 mm compared with 63.2 mm, P=.59) or other procedural time points. There were no differences in satisfaction or need for additional pain medications. Patients who received hydrocodone-acetaminophen had more postoperative nausea than those receiving placebo (P=.03) when controlling for baseline nausea. No medication-related adverse events were noted. Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea. Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459. I.

Adverse birth outcomes associated with Zika virus exposure during pregnancy in São José do Rio Preto, Brazil.

PubMed

Nogueira, M L; Nery Júnior, N R R; Estofolete, C F; Bernardes Terzian, A C; Guimarães, G F; Zini, N; Alves da Silva, R; Dutra Silva, G C; Junqueira Franco, L C; Rahal, P; Bittar, C; Carneiro, B; Vasconcelos, P F C; Freitas Henriques, D; Barbosa, D M U; Lopes Rombola, P; de Grande, L; Negri Reis, A F; Palomares, S A; Wakai Catelan, M; Cruz, L E A A; Necchi, S H; Mendonça, R C V; Penha Dos Santos, I N; Alavarse Caron, S B; Costa, F; Bozza, F A; Soares de Souza, A; Brandão de Mattos, C C; de Mattos, L C; Vasilakis, N; Oliani, A H; Vaz Oliani, D C M; Ko, A I

2018-06-01

We aimed to report the first 54 cases of pregnant women infected by Zika virus (ZIKV) and their virologic and clinical outcomes, as well as their newborns' outcomes, in 2016, after the emergence of ZIKV in dengue-endemic areas of São Paulo, Brazil. This descriptive study was performed from February to October 2016 on 54 quantitative real-time PCR ZIKV-positive pregnant women identified by the public health authority of São José do Rio Preto, São Paulo, Brazil. The women were followed and had clinical and epidemiologic data collected before and after birth. Adverse outcomes in newborns were analysed and reported. Urine or blood samples from newborns were collected to identify ZIKV infection by reverse transcription PCR (RT-PCR). A total of 216 acute Zika-suspected pregnant women were identified, and 54 had the diagnosis confirmed by RT-PCR. None of the 54 women miscarried. Among the 54 newborns, 15 exhibited adverse outcomes at birth. The highest number of ZIKV infections occurred during the second and third trimesters. No cases of microcephaly were reported, though a broad clinical spectrum of outcomes, including lenticulostriate vasculopathy, subependymal cysts, and auditory and ophthalmologic disorders, were identified. ZIKV RNA was detected in 18 of 51 newborns tested and in eight of 15 newborns with adverse outcomes. Although other studies have associated many newborn outcomes to ZIKV infection during pregnancy, these same adverse outcomes were rare or nonexistent in this study. The clinical presentation the newborns we studied was mild compared to other reports, suggesting that there is significant heterogeneity in congenital Zika infection. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Preoperative Determinants of Outcomes of Infant Heart Surgery in a Limited-Resource Setting.

PubMed

Reddy, N Srinath; Kappanayil, Mahesh; Balachandran, Rakhi; Jenkins, Kathy J; Sudhakar, Abish; Sunil, G S; Raj, R Benedict; Kumar, R Krishna

2015-01-01

We studied the effect of preoperative determinants on early outcomes of 1028 consecutive infant heart operations in a limited-resource setting. Comprehensive data on pediatric heart surgery (January 2010-December 2012) were collected prospectively. Outcome measures included in-hospital mortality, prolonged ventilation (>48 hours), and bloodstream infection (BSI) after surgery. Preoperative variables that showed significant individual association with outcome measures were entered into a logistic regression model. Weight at birth was low in 224 infants (21.8%), and failure to thrive was common (mean-weight Z score at surgery was 2.72 ± 1.7). Preoperatively, 525 infants (51%) needed intensive care, 69 infants (6.7%) were ventilated, and 80 infants (7.8%) had BSI. In-hospital mortality (4.1%) was significantly associated with risk adjustment for congenital heart surgery-1 (RACHS-1) risk category (P < 0.001). Neonatal status, preoperative BSI, and requirement of preoperative intensive care and ventilation had significant individual association with adverse outcomes, whereas low birth weight, prematurity, and severe failure to thrive (weight Z score <-3) were not associated with adverse outcomes. On multivariable logistic regression analysis, preoperative sepsis (odds ratio = 2.86; 95% CI: 1.32-6.21; P = 0.008) was associated with mortality. Preoperative intensive care unit stay, ventilation, BSI, and RACHS-1 category were associated with prolonged postoperative ventilation and postoperative sepsis. Neonatal age group was additionally associated with postoperative sepsis. Although severe failure to thrive was common, it did not adversely affect outcomes. In conclusions, preoperative BSI, preoperative intensive care, and mechanical ventilation are strongly associated with adverse outcomes after infant cardiac surgery in this large single-center experience from a developing country. Failure to thrive and low birth weight do not appear to adversely affect surgical outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

21 CFR 312.32 - IND safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... considered drug related. Life-threatening adverse event or life-threatening suspected adverse reaction. An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of either the... results in any of the following outcomes: Death, a life-threatening adverse event, inpatient...

21 CFR 312.32 - IND safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... considered drug related. Life-threatening adverse event or life-threatening suspected adverse reaction. An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of either the... results in any of the following outcomes: Death, a life-threatening adverse event, inpatient...

21 CFR 312.32 - IND safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... considered drug related. Life-threatening adverse event or life-threatening suspected adverse reaction. An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of either the... results in any of the following outcomes: Death, a life-threatening adverse event, inpatient...

10-year nationwide trends of the incidence, prevalence, and adverse outcomes of non-valvular atrial fibrillation nationwide health insurance data covering the entire Korean population.

PubMed

Kim, Daehoon; Yang, Pil-Sung; Jang, Eunsun; Yu, Hee Tae; Kim, Tae-Hoon; Uhm, Jae-Sun; Kim, Jong-Youn; Pak, Hui-Nam; Lee, Moon-Hyoung; Joung, Boyoung; Lip, Gregory Yh

2018-05-01

Most data on the clinical epidemiology of atrial fibrillation (AF) are reported from Western populations, and data for Asians are limited. We aimed to investigate the 10-year trends of the prevalence and incidence of non-valvular AF and provide prevalence projections till 2060 in Korea. We also investigated the annual risks of adverse outcomes among patients with AF. Using the Korean National Health Insurance Service database involving the entire Korean population, a total of 679,416 adults with newly diagnosed AF were identified from 2006 to 2015. The incidence and prevalence of AF and risk of adverse outcomes following AF onset were assessed. The prevalence of AF progressively increased by 2.10-fold from 0.73% in 2006 to 1.53% in 2015. The trend of its incidence was flat with a 10-year overall incidence of 1.77 per 1,000 person-years. The prevalence of AF is expected to reach 5.81% (2,290,591 patients with AF) in 2060. For a decade, the risk of all-cause mortality following AF declined by 30% (adjusted hazard ratio [HR]: 0.70, 95% confidence interval [CI]: 0.68-0.72), heart failure by 52% (adjusted HR: 0.48, 95% CI: 0.44-0.51), and ischemic stroke by 9% (adjusted HR: 0.91, 95% CI: 0.88-0.93). The burden of AF among Asian patients is increasing. Although the overall risks of cardiovascular events and death following AF onset have decreased over a decade, the event rates are still high. Optimized management of any associated comorbidities should be part of the holistic management approach for patients with AF. Copyright © 2018. Published by Elsevier Inc.

Surgical adverse outcome reporting as part of routine clinical care.

PubMed

Kievit, J; Krukerink, M; Marang-van de Mheen, P J

2010-12-01

In The Netherlands, health professionals have created a doctor-driven standardised system to report and analyse adverse outcomes (AO). The aim is to improve healthcare by learning from past experiences. The key elements of this system are (1) an unequivocal definition of an adverse outcome, (2) appropriate contextual information and (3) a three-dimensional hierarchical classification system. First, to assess whether routine doctor-driven AO reporting is feasible. Second, to investigate how doctors can learn from AO reporting and analysis to improve the quality of care. Feasibility was assessed by how well doctors reported AO in the surgical department of a Dutch university hospital over a period of 9 years. AO incidence was analysed per patient subgroup and over time, in a time-trend analysis of three equal 3-year periods. AO were analysed case by case and statistically, to learn lessons from past events. In 19,907 surgical admissions, 9189 AOs were reported: one or more AO in 18.2% of admissions. On average, 55 lessons were learnt each year (in 4.3% of AO). More AO were reported in P3 than P1 (OR 1.39 (1.23-1.57)). Although minor AO increased, fatal AO decreased over time (OR 0.59 (0.45-0.77)). Doctor-driven AO reporting is shown to be feasible. Lessons can be learnt from case-by-case analyses of individual AO, as well as by statistical analysis of AO groups and subgroups (illustrated by time-trend analysis), thus contributing to the improvement of the quality of care. Moreover, by standardising AO reporting, data can be compared across departments or hospitals, to generate (confidential) mirror information for professionals cooperating in a peer-review setting.

Surgical adverse outcome reporting as part of routine clinical care

PubMed Central

Krukerink, M; Marang-van de Mheen, P J

2010-01-01

Background In The Netherlands, health professionals have created a doctor-driven standardised system to report and analyse adverse outcomes (AO). The aim is to improve healthcare by learning from past experiences. The key elements of this system are (1) an unequivocal definition of an adverse outcome, (2) appropriate contextual information and (3) a three-dimensional hierarchical classification system. Objectives First, to assess whether routine doctor-driven AO reporting is feasible. Second, to investigate how doctors can learn from AO reporting and analysis to improve the quality of care. Methods Feasibility was assessed by how well doctors reported AO in the surgical department of a Dutch university hospital over a period of 9 years. AO incidence was analysed per patient subgroup and over time, in a time-trend analysis of three equal 3-year periods. AO were analysed case by case and statistically, to learn lessons from past events. Results In 19 907 surgical admissions, 9189 AOs were reported: one or more AO in 18.2% of admissions. On average, 55 lessons were learnt each year (in 4.3% of AO). More AO were reported in P3 than P1 (OR 1.39 (1.23–1.57)). Although minor AO increased, fatal AO decreased over time (OR 0.59 (0.45–0.77)). Conclusions Doctor-driven AO reporting is shown to be feasible. Lessons can be learnt from case-by-case analyses of individual AO, as well as by statistical analysis of AO groups and subgroups (illustrated by time-trend analysis), thus contributing to the improvement of the quality of care. Moreover, by standardising AO reporting, data can be compared across departments or hospitals, to generate (confidential) mirror information for professionals cooperating in a peer-review setting. PMID:20430928

Robotic cholecystectomy and resident education: the UC Davis experience.

PubMed

Nelson, Eric C; Gottlieb, Andrea H; Müller, Hans-Georg; Smith, William; Ali, Mohamed R; Vidovszky, Tamas J

2014-06-01

The popularity of robotic surgery highlights the need for strategies to integrate this technique into surgical education. We present 5 year data for robotic cholecystectomy (RC) as a model for training residents. Data were collected on all RC over 66 months. Duration for docking the robot (S2) and performing RC (S3), and surgical outcomes, were recorded. We used a linear mixed effects model to investigate learning curves. Thirty-eight trainees performed 160 RCs, with most performing more than four. One case was aborted due to haemodynamic instability, and two were converted to open surgery due to adhesions. There were no technical complications. The duration of S2 (mean = 6.2 ± 3.6 min) decreased considerably (p = 0.027). Trainees also demonstrated decrease in duration of S3 (mean = 38.4 ± 15.4 min), indicating improvement in technique (p = 0.008). RC is an effective model for teaching residents. Significant and reproducible improvement can be realized with low risk of adverse outcomes. Copyright © 2013 John Wiley & Sons, Ltd.

Revision of Articular Surface Replacement (ASR) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results.

PubMed

Cip, Johannes; Bach, Christian; Widemschek, Mark; Luegmair, Matthias; Martin, Arno

2015-09-01

The articular surface replacement (ASR) total hip arthroplasty (THA) showed accelerated failure rates due to adverse-reaction to metal debris (ARMD). Literature correlating preoperative with intraoperative revision findings respectively post-revision outcome results are rare. 30 of 99 available ASR THA were revised due to ARMD. Mean post-revision follow-up term was 2.3 years. In part, preoperative data did not correlate with intraoperative revision findings. ARMD was even found in asymptomatic patients with non-elevated ion levels. Postoperative pain and metal ions decreased significantly (P ≤ 0.016). Cobalt decreased faster than chrome. Patients with intraoperative pseudotumors, osteolysis or bilateral THA did not have higher pre- or postoperative ion values (P ≥ 0.053). Females showed higher postoperative chrome levels (P=0.031). One major post-revision complication (femoral nerve palsy) and one re-revision (late onset infection) occurred. Copyright © 2015 Elsevier Inc. All rights reserved.

Efficacy and toxicity of external-beam radiation therapy for localised prostate cancer: a network meta-analysis

PubMed Central

Zhu, Z; Zhang, J; Liu, Y; Chen, M; Guo, P; Li, K

2014-01-01

Background: Many radiation regimens for treating prostate cancer have been used over the years, but which regimen is optimal for localised or locally advanced prostate cancer lacks consensus. We performed a network meta-analysis to identify the optimal radiation regimen. Methods: We systematically reviewed data from 27 randomised controlled trials and could group seven radiation regimens as follows: low- and high-dose radiation therapy (LDRT and HDRT), LDRT+ short- or long-term androgen deprivation therapy (LDRT+SADT and LDRT+LADT), HDRT+SADT, hypofractionated radiotherapy (HFRT), and HFRT+SADT. The main outcomes were overall mortality (OM), prostate-specific antigen (PSA) failure, cancer-specific mortality, and adverse events. Results: For the network meta-analysis of 27 trials, LDRT+LADT and LDRT+SADT were associated with decreased risk of OM as compared with LDRT alone as was LDRT+LADT compared with HDRT. Apart from HFRT, all other treatments were associated with decreased risk of PSA failure as compared with LDRT. HFRT+SADT was associated with decreased risk of cancer-specific mortality as compared with HFRT, LDRT+SADT, HDRT, and LDRT. Conclusions: HFRT+SADT therapy might be the most efficacious treatment but with worst toxicity for localised or locally advanced prostate cancer, and HDRT showed excellent efficacy but more adverse events. PMID:24736585

Food insecurity, vitamin D insufficiency and respiratory infections among Inuit children.

PubMed

Tse, Sze Man; Weiler, Hope; Kovesi, Tom

2016-01-01

Food insecurity, vitamin D deficiency and lower respiratory tract infections are highly prevalent conditions among Inuit children. However, the relationship between these conditions has not been examined in this population. The objective of this study was to examine the relationship between food insecurity and severe respiratory infections before age 2 years and health centre visits for a respiratory problem in the past year. We also explored the relationship between serum vitamin D status and respiratory outcomes in this population. We included children aged 3-5 years who participated in a cross-sectional survey of the health of preschool Inuit children in Nunavut, Canada, from 2007 to 2008 (n=388). Parental reports of severe respiratory infections in the first 2 years of life and health care visits in the past 12 months were assessed through a questionnaire. Child and adult food security were assessed separately and serum 25-hydroxyvitamin D3 levels were measured in a subgroup of participants (n=279). Multivariate logistic regression was performed to assess the association between food security, vitamin D and each of the 2 respiratory outcomes. Child and adult food insecurity measures were not significantly associated with adverse respiratory outcomes. Household crowding [odds ratio (OR)=1.51, 95% confidence interval (CI) 1.09-2.09, p=0.01 for the child food security model] and higher birth weight (OR=1.21, 95% CI: 1.02-1.43, p=0.03) were associated with reported severe chest infections before age 2 years while increasing age was associated with decreased odds of reported health care visits for a respiratory problem (OR=0.66, 95% CI: 0.48-0.91, p=0.02). Neither vitamin D insufficiency nor deficiency was associated with these respiratory outcomes. Using a large cross-sectional survey of Inuit children, we found that household crowding, but not food security or vitamin D levels, was associated with adverse respiratory outcomes. Further studies are warranted to examine the impact of decreasing household crowding on the respiratory health of these children.

Food insecurity, vitamin D insufficiency and respiratory infections among Inuit children

PubMed Central

Tse, Sze Man; Weiler, Hope; Kovesi, Tom

2016-01-01

Background Food insecurity, vitamin D deficiency and lower respiratory tract infections are highly prevalent conditions among Inuit children. However, the relationship between these conditions has not been examined in this population. Objective The objective of this study was to examine the relationship between food insecurity and severe respiratory infections before age 2 years and health centre visits for a respiratory problem in the past year. We also explored the relationship between serum vitamin D status and respiratory outcomes in this population. Design We included children aged 3–5 years who participated in a cross-sectional survey of the health of preschool Inuit children in Nunavut, Canada, from 2007 to 2008 (n=388). Parental reports of severe respiratory infections in the first 2 years of life and health care visits in the past 12 months were assessed through a questionnaire. Child and adult food security were assessed separately and serum 25-hydroxyvitamin D3 levels were measured in a subgroup of participants (n=279). Multivariate logistic regression was performed to assess the association between food security, vitamin D and each of the 2 respiratory outcomes. Results Child and adult food insecurity measures were not significantly associated with adverse respiratory outcomes. Household crowding [odds ratio (OR)=1.51, 95% confidence interval (CI) 1.09–2.09, p=0.01 for the child food security model] and higher birth weight (OR=1.21, 95% CI: 1.02–1.43, p=0.03) were associated with reported severe chest infections before age 2 years while increasing age was associated with decreased odds of reported health care visits for a respiratory problem (OR=0.66, 95% CI: 0.48–0.91, p=0.02). Neither vitamin D insufficiency nor deficiency was associated with these respiratory outcomes. Conclusions Using a large cross-sectional survey of Inuit children, we found that household crowding, but not food security or vitamin D levels, was associated with adverse respiratory outcomes. Further studies are warranted to examine the impact of decreasing household crowding on the respiratory health of these children. PMID:26895394

Randomized, multicenter trial of lateral Trendelenburg versus semirecumbent body position for the prevention of ventilator-associated pneumonia.

PubMed

Li Bassi, Gianluigi; Panigada, Mauro; Ranzani, Otavio T; Zanella, Alberto; Berra, Lorenzo; Cressoni, Massimo; Parrini, Vieri; Kandil, Hassan; Salati, Giovanni; Selvaggi, Paola; Amatu, Alessandro; Sanz-Moncosi, Miquel; Biagioni, Emanuela; Tagliaferri, Fernanda; Furia, Mirella; Mercurio, Giovanna; Costa, Antonietta; Manca, Tullio; Lindau, Simone; Babel, Jaksa; Cavana, Marco; Chiurazzi, Chiara; Marti, Joan-Daniel; Consonni, Dario; Gattinoni, Luciano; Pesenti, Antonio; Wiener-Kronish, Janine; Bruschi, Cecilia; Ballotta, Andrea; Salsi, Pierpaolo; Livigni, Sergio; Iotti, Giorgio; Fernandez, Javier; Girardis, Massimo; Barbagallo, Maria; Moise, Gabriella; Antonelli, Massimo; Caspani, Maria Luisa; Vezzani, Antonella; Meybohm, Patrick; Gasparovic, Vladimir; Geat, Edoardo; Amato, Marcelo; Niederman, Michael; Kolobow, Theodor; Torres, Antoni

2017-11-01

The lateral Trendelenburg position (LTP) may hinder the primary pathophysiologic mechanism of ventilator-associated pneumonia (VAP). We investigated whether placing patients in the LTP would reduce the incidence of VAP in comparison with the semirecumbent position (SRP). This was a randomized, multicenter, controlled study in invasively ventilated critically ill patients. Two preplanned interim analyses were performed. Patients were randomized to be placed in the LTP or the SRP. The primary outcome, assessed by intention-to-treat analysis, was incidence of microbiologically confirmed VAP. Major secondary outcomes included mortality, duration of mechanical ventilation, and intensive care unit length of stay. At the second interim analysis, the trial was stopped because of low incidence of VAP, lack of benefit in secondary outcomes, and occurrence of adverse events. A total of 194 patients in the LTP group and 201 in the SRP group were included in the final intention-to-treat analysis. The incidence of microbiologically confirmed VAP was 0.5% (1/194) and 4.0% (8/201) in LTP and SRP patients, respectively (relative risk 0.13, 95% CI 0.02-1.03, p = 0.04). The 28-day mortality was 30.9% (60/194) and 26.4% (53/201) in LTP and SRP patients, respectively (relative risk 1.17, 95% CI 0.86-1.60, p = 0.32). Likewise, no differences were found in other secondary outcomes. Six serious adverse events were described in LTP patients (p = 0.01 vs. SRP). The LTP slightly decreased the incidence of microbiologically confirmed VAP. Nevertheless, given the early termination of the trial, the low incidence of VAP, and the adverse events associated with the LTP, the study failed to prove any significant benefit. Further clinical investigation is strongly warranted; however, at this time, the LTP cannot be recommended as a VAP preventive measure. CLINICALTRIALS. NCT01138540.

Incidence of adverse events in Sweden during 2013–2016: a cohort study describing the implementation of a national trigger tool

PubMed Central

Nilsson, Lena; Borgstedt-Risberg, Madeleine; Soop, Michael; Nylén, Urban; Ålenius, Carina; Rutberg, Hans

2018-01-01

Objectives To describe the implementation of a trigger tool in Sweden and present the national incidence of adverse events (AEs) over a 4-year period during which an ongoing national patient safety initiative was terminated. Design Cohort study using retrospective record review based on a trigger tool methodology. Setting and participants Patients ≥18 years admitted to all somatic acute care hospitals in Sweden from 2013 to 2016 were randomised into the study. Primary and secondary outcome measures Primary outcome measure was the incidence of AEs, and secondary measures were type of injury, severity of harm, preventability of AEs, estimated healthcare cost of AEs and incidence of AEs in patients cared for in another type of unit than the one specialised for their medical needs (‘off-site’). Results In a review of 64 917 admissions, the average AE rates in 2014 (11.6%), 2015 (10.9%) and 2016 (11.4%) were significantly lower than in 2013 (13.1%). The decrease in the AE rates was seen in different age groups, in both genders and for preventable and non-preventable AEs. The decrease comprised only the least severe AEs. The types of AEs that decreased were hospital-acquired infections, urinary bladder distention and compromised vital signs. Patients cared for ‘off-site’ had 84% more preventable AEs than patients cared for in the appropriate units. The cost of increased length of stay associated with preventable AEs corresponded to 13%–14% of the total cost of somatic hospital care in Sweden. Conclusions The rate of AEs in Swedish somatic hospitals has decreased from 2013 to 2016. Retrospective record review can be used to monitor patient safety over time, to assess the effects of national patient safety interventions and analyse challenges to patient safety such as the increasing care of patients ‘off-site’. It was found that the economic burden of preventable AEs is high. PMID:29602858

Allostatic load: A theoretical model for understanding the relationship between maternal posttraumatic stress disorder and adverse birth outcomes.

PubMed

Li, Yang; Rosemberg, Marie-Anne Sanon; Seng, Julia S

2018-07-01

Adverse birth outcomes such as preterm birth and low birth weight are significant public health concerns and contribute to neonatal morbidity and mortality. Studies have increasingly been exploring the predictive effects of maternal posttraumatic stress disorder (PTSD) on adverse birth outcomes. However, the biological mechanisms by which maternal PTSD affects birth outcomes are not well understood. Allostatic load refers to the cumulative dysregulations of the multiple physiological systems as a response to multiple social-ecological levels of chronic stress. Allostatic load has been well documented in relation to both chronic stress and adverse health outcomes in non-pregnant populations. However, the mediating role of allostatic load is less understood when it comes to maternal PTSD and adverse birth outcomes. To propose a theoretical model that depicts how allostatic load could mediate the impact of maternal PTSD on birth outcomes. We followed the procedures for theory synthesis approach described by Walker and Avant (2011), including specifying focal concepts, identifying related factors and relationships, and constructing an integrated representation. We first present a theoretical overview of the allostatic load theory and the other 4 relevant theoretical models. Then we provide a brief narrative review of literature that empirically supports the propositions of the integrated model. Finally, we describe our theoretical model. The theoretical model synthesized has the potential to advance perinatal research by delineating multiple biomarkers to be used in future. After it is well validated, it could be utilized as the theoretical basis for health care professionals to identify high-risk women by evaluating their experiences of psychosocial and traumatic stress and to develop and evaluate service delivery and clinical interventions that might modify maternal perceptions or experiences of stress and eliminate their impacts on adverse birth outcomes. Copyright © 2018. Published by Elsevier Ltd.

Iodine supplementation for women during the preconception, pregnancy and postpartum period.

PubMed

Harding, Kimberly B; Peña-Rosas, Juan Pablo; Webster, Angela C; Yap, Constance My; Payne, Brian A; Ota, Erika; De-Regil, Luz Maria

2017-03-05

Iodine is an essential nutrient required for the biosynthesis of thyroid hormones, which are responsible for regulating growth, development and metabolism. Iodine requirements increase substantially during pregnancy and breastfeeding. If requirements are not met during these periods, the production of thyroid hormones may decrease and be inadequate for maternal, fetal and infant needs. The provision of iodine supplements may help meet the increased iodine needs during pregnancy and the postpartum period and prevent or correct iodine deficiency and its consequences. To assess the benefits and harms of supplementation with iodine, alone or in combination with other vitamins and minerals, for women in the preconceptional, pregnancy or postpartum period on their and their children's outcomes. We searched Cochrane Pregnancy and Childbirth's Trials Register (14 November 2016), and the WHO International Clinical Trials Registry Platform (ICTRP) (17 November 2016), contacted experts in the field and searched the reference lists of retrieved studies and other relevant papers. Randomized and quasi-randomized controlled trials with randomisation at either the individual or cluster level comparing injected or oral iodine supplementation (such as tablets, capsules, drops) during preconception, pregnancy or the postpartum period irrespective of iodine compound, dose, frequency or duration. Two review authors independently assessed trial eligibility, risk of bias, extracted data and conducted checks for accuracy. We used the GRADE approach to assess the quality of the evidence for primary outcomes.We anticipated high heterogeneity among trials, and we pooled trial results using random-effects models and were cautious in our interpretation of the pooled results. We included 14 studies and excluded 48 studies. We identified five ongoing or unpublished studies and two studies are awaiting classification. Eleven trials involving over 2700 women contributed data for the comparisons in this review (in three trials, the primary or secondary outcomes were not reported). Maternal primary outcomesIodine supplementation decreased the likelihood of the adverse effect of postpartum hyperthyroidism by 68% (average risk ratio (RR) 0.32; 95% confidence interval (CI) 0.11 to 0.91, three trials in mild to moderate iodine deficiency settings, 543 women, no statistical heterogeneity, low-quality evidence) and increased the likelihood of the adverse effect of digestive intolerance in pregnancy by 15 times (average RR 15.33; 95% CI 2.07 to 113.70, one trial in a mild-deficiency setting, 76 women, very low-quality evidence).There were no clear differences between groups for hypothyroidism in pregnancy or postpartum (pregnancy: average RR 1.90; 95% CI 0.57 to 6.38, one trial, 365 women, low-quality evidence, and postpartum: average RR 0.44; 95% CI 0.06 to 3.42, three trials, 540 women, no statistical heterogeneity, low-quality evidence), preterm birth (average RR 0.71; 95% CI 0.30 to 1.66, two trials, 376 women, statistical heterogeneity, low-quality evidence) or the maternal adverse effects of elevated thyroid peroxidase antibodies (TPO-ab) in pregnancy or postpartum (average RR 0.95; 95% CI 0.44 to 2.07, one trial, 359 women, low-quality evidence, average RR 1.01; 95% CI 0.78 to 1.30, three trials, 397 women, no statistical heterogeneity, low-quality evidence), or hyperthyroidism in pregnancy (average RR 1.90; 95% CI 0.57 to 6.38, one trial, 365 women, low-quality evidence). All of the trials contributing data to these outcomes took place in settings with mild to moderate iodine deficiency. Infant/child primary outcomesCompared with those who did not receive iodine, those who received iodine supplements had a 34% lower likelihood of perinatal mortality, however this difference was not statistically significant (average RR 0.66; 95% CI 0.42 to 1.03, two trials, 457 assessments, low-quality evidence). All of the perinatal deaths occurred in one trial conducted in a severely iodine-deficient setting. There were no clear differences between groups for low birthweight (average RR 0.56; 95% CI 0.26 to 1.23, two trials, 377 infants, no statistical heterogeneity, low-quality evidence), neonatal hypothyroidism/elevated thyroid-stimulating hormone (TSH) (average RR 0.58; 95% CI 0.11 to 3.12, two trials, 260 infants, very low-quality evidence) or the adverse effect of elevated neonatal thyroid peroxidase antibodies (TPO-ab) (average RR 0.61; 95% CI 0.07 to 5.70, one trial, 108 infants, very low-quality evidence). All of the trials contributing data to these outcomes took place in areas with mild to moderate iodine deficiency. No trials reported on hypothyroidism/elevated TSH or any adverse effect beyond the neonatal period. There were insufficient data to reach any meaningful conclusions on the benefits and harms of routine iodine supplementation in women before, during or after pregnancy. The available evidence suggested that iodine supplementation decreases the likelihood of postpartum hyperthyroidism and increases the likelihood of the adverse effect of digestive intolerance in pregnancy - both considered potential adverse effects. We considered evidence for these outcomes low or very low quality, however, because of study design limitations and wide confidence intervals. In addition, due to the small number of trials and included women in our meta-analyses, these findings must be interpreted with caution. There were no clear effects on other important maternal or child outcomes though these findings must also be interpreted cautiously due to limited data and low-quality trials. Additionally, almost all of the evidence came from settings with mild or moderate iodine deficiency and therefore may not be applicable to settings with severe deficiency.More high-quality randomised controlled trials are needed on iodine supplementation before, during and after pregnancy on maternal and infant/child outcomes. However, it may be unethical to compare iodine to placebo or no treatment in severe deficiency settings. Trials may also be unfeasible in settings where pregnant and lactating women commonly take prenatal supplements with iodine. Information is needed on optimal timing of initiation as well as supplementation regimen and dose. Future trials should consider the outcomes in this review and follow children beyond the neonatal period. Future trials should employ adequate sample sizes, assess potential adverse effects (including the nature and extent of digestive intolerance), and be reported in a way that allows assessment of risk of bias, full data extraction and analysis by the subgroups specified in this review.

Adverse outcome pathway (AOP) development and evaluation

EPA Science Inventory

The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be mea...

Adverse Outcome Pathways and Extrapolation Tools to Advance the Three Rs in Ecotoxicology

EPA Science Inventory

Adverse outcome pathways (AOPs) are conceptual frameworks for identifying and organizing predictive and causal linkages between cellular-level responses and endpoints conventionally considered in ecological risk assessment (e.g., effects on survival, growth/development, and repro...

.Network analytics for adverse outcome pathways

EPA Science Inventory

Adverse Outcome Pathways (AOPs) organize toxicological knowledge from the molecular level up to the population level, providing evidence-based causal linkages at each step. The AOPWiki serves as a repository of AOPs. With the international adoption of the AOP framework, the AOPw...

The adverse outcome pathway knowledge base

EPA Science Inventory

The rapid advancement of the Adverse Outcome Pathway (AOP) framework has been paralleled by the development of tools to store, analyse, and explore AOPs. The AOP Knowledge Base (AOP-KB) project has brought three independently developed platforms (Effectopedia, AOP-Wiki, and AOP-X...

ADVERSE PREGNANCY OUTCOMES ASSOCIATED WITH MATERNAL ENALAPRIL ANTIHYPERTENSIVE TREATMENT

EPA Science Inventory

Enalapril, one of several antihypertensive drugs that act as angiotensin-converting enzyme (ACE) inhibitors, is often used for treatment of hypertension in women of reproductive age. Adverse birth outcomes following the use of ACE inhibitors, including enalapril, during pregnanc...

Integrating toxicogenomics data into cancer adverse outcome pathways

EPA Science Inventory

Integrating toxicogenomics data into adverse outcome pathways for cancer.J. Christopher CortonNHEERL/ORD, EPA, Research Triangle Park, NCAs the toxicology field continues to move towards a new paradigm in toxicity testing and safety assessment, there is the expectation that model...

Information handoff and outcomes of critically ill patients transferred between hospitals

PubMed Central

Usher, Michael G.; Fanning, Christine; Wu, Di; Muglia, Christine; Balonze, Karen; Kim, Deborah; Parikh, Amay; Herrigel, Dana

2016-01-01

Purpose Patients transferred between hospitals are at high risk of adverse events and mortality. This study aims to identify which components of the transfer handoff process are important predictors of adverse events and mortality. Materials and Methods We conducted a retrospective, observational study of 335 consecutive patient transfers to three ICUs at an academic tertiary referral center. We assessed the relationship between handoff documentation completeness and patient outcomes. The primary outcome was in-hospital mortality. Secondary outcomes included adverse events, duplication of labor, disposition error, and length of stay. Results Transfer documentation was frequently absent with overall completeness of 58.3%. Adverse events occurred in 42% of patients within 24 hours of arrival, with an overall in-hospital mortality of 17.3%. Higher documentation completeness was associated with reduced in-hospital mortality (OR 0.07, 95% CI 0.02 to 0.38, p=0.002), reduced adverse events (coef −2.08, 95% CI −2.76 to −1.390, p<0.001), and reduced duplication of labor (OR 0.19, 95% CI 0.04 to 0.88, p=0.033) when controlling for severity of illness. Conclusions Documentation completeness is associated with improved outcomes and resource utilization in patients transferred between hospitals. PMID:27591388

Frequency, Risk Factors, and Adverse Fetomaternal Outcomes of Placenta Previa in Northern Tanzania

PubMed Central

Senkoro, Elizabeth Eliet; Mwanamsangu, Amasha H.; Chuwa, Fransisca Seraphin; Msuya, Sia Emmanuel; Mnali, Oresta Peter

2017-01-01

Background and Objective. Placenta previa (PP) is a potential risk factor for obstetric hemorrhage, which is a major cause of fetomaternal morbidity and mortality in developing countries. This study aimed to determine frequency, risk factors, and adverse fetomaternal outcomes of placenta previa in Northern Tanzania. Methodology. A retrospective cohort study was conducted using maternally-linked data from Kilimanjaro Christian Medical Centre birth registry spanning 2000 to 2015. All women who gave birth to singleton infants were studied. Adjusted odds ratios (ORs) with 95% confidence intervals for risk factors and adverse fetomaternal outcomes associated with PP were estimated in multivariable logistic regression models. Result. A total of 47,686 singleton deliveries were analyzed. Of these, the frequency of PP was 0.6%. Notable significant risk factors for PP included gynecological diseases, alcohol consumption during pregnancy, malpresentation, and gravidity ≥5. Adverse maternal outcomes were postpartum haemorrhage, antepartum haemorrhage, and Caesarean delivery. PP increased odds of fetal Malpresentation and early neonatal death. Conclusion. The prevalence of PP was comparable to that found in past research. Multiple independent risk factors were identified. PP was found to have associations with several adverse fetomaternal outcomes. Early identification of women at risk of PP may help clinicians prevent such complications. PMID:28321338

21 CFR 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false If I am a user facility, what information must I submit in my individual adverse event reports? 803.32 Section 803.32 Food and Drugs FOOD AND DRUG... problem; (2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is...

21 CFR 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false If I am a manufacturer, what information must I submit in my individual adverse event reports? 803.52 Section 803.52 Food and Drugs FOOD AND DRUG... product problem; (2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome...

Drinking water disinfection by-products exposure and health effects on pregnancy outcomes: a systematic review.

PubMed

Mashau, Funanani; Ncube, Esper Jacobeth; Voyi, Kuku

2018-04-01

Epidemiological studies have found that maternal exposure to disinfection by-products (DBPs) may lead to adverse pregnancy outcomes although the findings tend to be inconsistent. The objective of this study was to systematically review the evidence in associated with drinking water DBP exposure in relation to adverse pregnancy outcomes. Peer-reviewed articles were identified using electronic databases searched for studies published in the English language. Studies selected for review were evaluated for exposure assessment, confounders, and analyses risks of bias in the selection, outcomes assessment, and attrition. A comprehensive search and screening yielded a total of 32 studies, of which 12 (38%) reported a statistical association between maternal exposure to DBPs and adverse pregnancy outcomes. A maternal exposure to trihalomethanes (THMs) shows an increased risk of small for gestational age (SGA) and slightly increased risk of pregnancy loss. Risks of bias were low among the studies included in the review. Evidence on association relating to adverse pregnancy outcomes to DBP exposure is still less significant. There is a need for future robust research in this field, with the use of urinary trichloroacetic acid (TCAA) biomarkers as a direct exposure assessment method for this field.

Assessing Adverse Events of Postprostatectomy Radiation Therapy for Prostate Cancer: Evaluation of Outcomes in the Regione Emilia-Romagna, Italy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Showalter, Timothy N., E-mail: tns3b@virginia.edu; Hegarty, Sarah E.; Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania

Purpose: Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events. Methods: The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapymore » were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate. Results: A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes). Conclusion: Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However, the timing of radiation therapy did not influence the risk of radiation therapy–associated adverse events in this cohort, which contradicts the commonly held clinical tenet that delaying radiation therapy reduces the risk of adverse events.« less

Elevated risk of adverse obstetric outcomes in pregnant women with depression.

PubMed

Kim, Deborah R; Sockol, Laura E; Sammel, Mary D; Kelly, Caroline; Moseley, Marian; Epperson, C Neill

2013-12-01

In this study, we evaluated the association between prenatal depression symptoms adverse birth outcomes in African-American women. We conducted a retrospective cohort study of 261 pregnant African-American women who were screened with the Edinburgh Postnatal Depression Scale (EPDS) at their initial prenatal visit. Medical records were reviewed to assess pregnancy and neonatal outcomes, specifically preeclampsia, preterm birth, intrauterine growth retardation, and low birth weight. Using multivariable logistic regression models, an EPDS score ≥10 was associated with increased risk for preeclampsia, preterm birth, and low birth weight. An EPDS score ≥10 was associated with increased risk for intrauterine growth retardation, but after controlling for behavioral risk factors, this association was no longer significant. Patients who screen positive for depression symptoms during pregnancy are at increased risk for multiple adverse birth outcomes. In a positive, patient-rated depression screening at the initial obstetrics visit, depression is associated with increased risk for multiple adverse birth outcomes. Given the retrospective study design and small sample size, these findings should be confirmed in a prospective cohort study.

A Review of the Health Benefits of Greenness

PubMed Central

James, Peter; Banay, Rachel F.; Hart, Jaime E.; Laden, Francine

2015-01-01

Researchers are increasingly exploring how neighborhood greenness, or vegetation, may affect health behaviors and outcomes. Greenness may influence health by promoting physical activity and social contact; decreasing stress; and mitigating air pollution, noise, and heat exposure. Greenness is generally measured using satellite-based vegetation indices or land-use databases linked to participants’ addresses. In this review, we found fairly strong evidence for a positive association between greenness and physical activity, and a less consistent negative association between greenness and body weight. Research suggests greenness is protective against adverse mental health outcomes, cardiovascular disease, and mortality, though most studies were limited by cross-sectional or ecological design. There is consistent evidence that greenness exposure during pregnancy is positively associated with birth weight, though findings for other birth outcomes are less conclusive. Future research should follow subjects prospectively, differentiate between greenness quantity and quality, and identify mediators and effect modifiers of greenness-health associations. PMID:26185745

Advances in family-based interventions in the neonatal ICU.

PubMed

Welch, Martha G; Myers, Michael M

2016-04-01

Despite advances in medical care, preterm infants remain at risk for many adverse outcomes. This article reviews findings from several recent neonatal ICU (NICU) interventions and a trial of a novel nurture-based approach, Family Nurture Intervention (FNI). Recent trials reviewed here find positive effects of a variety of family-related interventions focused on parental guidance. These interventions target prescribed physical activities with infants, parents' stress, and the parents' ability to recognize their positive and negative behaviors with their infants. Beneficial effects include reductions in parenting stress, maternal anxiety, and depression. A different approach, FNI, is aimed at establishing mother-infant emotional connection. As in other trials, FNI also decreased maternal symptoms of anxiety and depression, and increased maternal sensitivity. Additionally, FNI led to positive short and long-term effects on infant neurobehavioral outcomes at term and 18 months. A number of recent parent-based NICU interventions have been effective at reducing preterm parent stress. Another, FNI, has positive effects on both maternal and infant outcomes and promises to be cost-effective. Future decreases in long-term morbidity in preterm infants will increasingly rely on nonmedical interventions. Therefore, the rigorous development and testing of such interventions should be a high priority in perinatology research.

Treatment of primary hyperhidrosis with oral anticholinergic medications: a systematic review.

PubMed

Cruddas, L; Baker, D M

2017-06-01

Primary hyperhidrosis is a condition characterized by excessive sweating. Patients are treated off-license with oral anticholinergic medications and report adverse events associated with systemic anticholinergic interactions. This review assesses clinical evidence of efficacy, impact on quality of life and adverse events associated with oral anticholinergic therapy for primary hyperhidrosis. PRISMA guidelines were implemented to complete a systematic review (PROSPERO:CRD42016036326). MEDLINE, EMBASE and PubMed were searched from 1946 to 2015. Inclusion criteria included observational and experimental studies, anticholinergic medication use in primary hyperhidrosis, oral therapy and clear diagnostic and outcome measures. Twenty-three articles relevant to the inclusion criteria were analysed. Oxybutynin therapy improved symptoms in an average of 76.2% (range 60-97%) patients and improved QOL in 75.6% (range 57.6-100%) of patients. Methantheline bromide therapy was associated with a 41% reduction in axillary sweating, 16.4% reduction in palmar sweating, 25% decrease in HDSS score and 40.9% increase in DLQI score. Outcome measures of glycopyrrolate therapy were too variable to collate. Dry mouth was reported in 73.4% (range 43.3-100%) of participants taking oxybutynin 10 mg/day, 38.6% (range 27.8-63.2%) of patients taking glycopyrrolate and 68.8% of patients taking methantheline bromide. Nine studies reported that patients stopped therapy due to adverse events. In eight of these studies, a mean of 10.9% of total participants ceased treatment due to dry mouth. Evidence of oral anticholinergic therapy for hyperhidrosis is limited. However, its use is associated with improvement in quality of life and clinical symptoms but at the cost of considerable adverse events. © 2016 European Academy of Dermatology and Venereology.

Excess iron intake as a factor in growth, infections, and development of infants and young children.

PubMed

Lönnerdal, Bo

2017-12-01

The provision of iron via supplementation or the fortification of foods has been shown to be effective in preventing and treating iron deficiency and iron deficiency anemia in infants and young children. However, iron is a pro-oxidative element and can have negative effects on biological systems even at moderate amounts. An increasing number of studies have reported adverse effects of iron that was given to infants and young-children populations who initially were iron replete. These effects include decreased growth (both linear growth and weight), increased illness (usually diarrhea), interactions with other trace elements such as copper and zinc, altered gut microbiota to more pathogenic bacteria, increased inflammatory markers, and impaired cognitive and motor development. If these results can be confirmed by larger and well-controlled studies, it may have considerable programmatic implications (e.g., the necessity to screen for iron status before interventions to exclude iron-replete individuals). A lack of understanding of the mechanisms underlying these adverse outcomes limits our ability to modify present supplementation and fortification strategies. This review summarizes studies on the adverse effects of iron on various outcomes; suggests possible mechanisms that may explain these observations, which are usually made in clinical studies and intervention trials; and gives examples from animal models and in vitro studies. With a better understanding of these mechanisms, it may be possible to find novel ways of providing iron in a form that causes fewer or no adverse effects even when subjects are iron replete. However, it is apparent that our understanding is limited, and research in this area is urgently needed. © 2017 American Society for Nutrition.

Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons.

PubMed

Li, Rongxia; Stewart, Brock; McNeil, Michael M; Duffy, Jonathan; Nelson, Jennifer; Kawai, Alison Tse; Baxter, Roger; Belongia, Edward A; Weintraub, Eric

2016-08-01

The changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillance for seven pre-specified adverse events following receipt of influenza vaccines during the 2013-2014 and 2014-2015 seasons in the Vaccine Safety Datalink (VSD). We used both a historically-controlled cohort design with the Poisson-based maximized sequential probability ratio test (maxSPRT) and a self-controlled risk interval (SCRI) design with the binomial-based maxSPRT. For each adverse event outcome, we defined the risk interval on the basis of biologic plausibility and prior literature. For the historical cohort design, numbers of expected adverse events were calculated from the prior seven seasons, adjusted for age and site. For the SCRI design, a comparison window was defined either before vaccination or after vaccination, depending on each specific outcome. An elevated risk of febrile seizures 0-1 days following trivalent inactivated influenza vaccine (IIV3) was identified in children aged 6-23 months during the 2014-2015 season using the SCRI design. We found the relative risk (RR) of febrile seizures following concomitant administration of IIV3 and PCV13 was 5.3 with a 95% CI 1.87-14.75. Without concomitant PCV 13 administration, the estimated risk decreased and was no longer statistically significant (RR: 1.4; CI: 0.54 - 3.61). No increased risks, other than for febrile seizures, were identified in influenza vaccine safety surveillance during 2013-2014 and 2014-2015 seasons in the VSD. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Advancing the adverse outcome pathway framework - An international horizon scanning approach (presentation)

EPA Science Inventory

In preparation for a Society of Environmental Toxicology and Chemistry Pellston Workshop titled “Advancing the Adverse Outcome Pathway (AOP) Concept: An International Horizon Scanning Approach,” a horizon scanning effort was undertaken to gather input from the global ...

Development & Use of Adverse Outcome Pathways for 21st Century Decision Support

EPA Science Inventory

The Adverse Outcome Pathway has emerged as an internationally harmonized mechanism for organizing biological information in a chemical agnostic manner. This construct is valuable for interpreting the results from high-throughput toxicity (HTT) assessment by providing a mechanisti...

Building predictive gene signatures through simultaneous assessment of transcription factor activation and gene expression.

EPA Science Inventory

Building predictive gene signatures through simultaneous assessment of transcription factor activation and gene expression Exposure to many drugs and environmentally-relevant chemicals can cause adverse outcomes. These adverse outcomes, such as cancer, have been linked to mol...

EMBRYONIC VASCULAR DISRUPTION ADVERSE OUTCOMES: LINKING HIGH THROUGHPUT SIGNALING SIGNATURES WITH FUNCTIONAL CONSEQUENCES

EPA Science Inventory

Embryonic vascular disruption is an important adverse outcome pathway (AOP) given the knowledge that chemical disruption of early cardiovascular system development leads to broad prenatal defects. High throughput screening (HTS) assays provide potential building blocks for AOP d...

Experimental Approaches to Systematic Discovery and Development of Reproductive Adverse Outcome Pathways in Fish

EPA Science Inventory

Adverse outcome pathways (AOPs) are conceptual frameworks that portray causal and predictive linkages between key events at multiple scales of biological organization that connect molecular initiating events and early cellular perturbations (e.g., initiation of toxicity pathways)...

An Integrative Data Mining Approach to Identify Adverse Outcome Pathway Signatures

EPA Science Inventory

Adverse Outcome Pathways (AOPs) provide a formal framework for describing the mechanisms underlying the toxicity of chemicals in our environment. This process improves our ability to incorporate high-throughput toxicity testing (HTT) results and biomarker information on early key...

Adverse Outcome Pathways – Organizing Toxicological Information to Improve Decision Making

EPA Science Inventory

The number of chemicals for which environmental regulatory decisions are required far exceeds the current capacity for toxicity testing. High throughput screening (HTS) commonly used for drug discovery has the potential to increase this capacity. The adverse outcome pathway (AOP)...

Realizing the promise of AOPs: A stakeholder-driven roadmap to the future

EPA Science Inventory

The adverse outcome pathway (AOP) framework was developed to serve as a knowledge assembly and communication tool to facilitate translation of mechanistic (e.g., molecular, biochemical, histological) data into adverse apical outcomes meaningful to chemical risk assessment. Althou...

Use of Putative Adverse Outcome Pathways for Chemical Hazard Identification

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework provides a knowledge infrastructure for evaluating health effects of environmental chemicals. In this work we are examining proof-of-concept issues in the development and prospective application of AOPs in chemical safety. Key outputs i...

VIOLENT CRIME EXPOSURE CLASSIFICATION AND ADVERSE BIRTH OUTCOMES: A GEOGRAPHICALLY-DEFINED COHORT STUDY

EPA Science Inventory

Background

Area-level socioeconomic disparities have long been associated with adverse pregnancy outcomes. Crime is an important element of the neighborhood environment inadequately investigated in the public health literature. Using geocoded linked birth, crime and cens...

Establishing Adverse Outcome Pathways of Thyroid Hormone Disruption in an Amphibian Model

EPA Science Inventory

The Adverse Outcome Pathway (AOP) provides a framework for understanding the relevance of toxicology data in ecotoxicological hazard assessments. The AOP concept can be applied to many toxicological pathways including thyroid hormone disruption. Thyroid hormones play a critical r...

Adverse effects of caffeinated energy drinks among youth and young adults in Canada: a Web-based survey

PubMed Central

Hammond, David; Reid, Jessica L.; Zukowski, Sara

2018-01-01

Background: Energy drink consumption has increased dramatically among young Canadians, with anecdotal evidence of adverse health effects. There is a lack of population-based studies to examine the prevalence of adverse events from energy drinks, particularly among young people. The current study sought to assess adverse events from energy drinks among a population-based sample of youth and young adults in Canada. Methods: An online survey was conducted in 2015 with a national sample of youth (aged 12-17 yr) and young adults (aged 18-24 yr) recruited from a consumer panel. Respondents reported prior consumption of energy drinks as well as adverse outcomes, concurrent activities associated with the outcomes and whether medical attention was sought or considered. Adverse events from coffee were also assessed for comparison. Weighted analyses are reported. Results: Of the 2055 respondents, 1516 (73.8%) reported having ever consumed an energy drink, and 1741 (84.7%) reported having ever consumed coffee (unweighted). Overall, 55.4% of respondents who had ever consumed an energy drink reported that they had experienced at least 1 adverse event, including fast heartbeat (24.7%), difficulty sleeping (24.1%), headache (18.3%), nausea/vomiting/diarrhea (5.1%), chest pain (3.6%) and seizures (0.2%); 3.1% had sought or had considered seeking medical help for an adverse event. The prevalence of reported adverse events was significantly greater among energy drink consumers than among coffee consumers (36.0%) (odds ratio [OR] 2.67 [95% confidence interval (CI) 2.01-2.56]), as was the proportion who reported seeking or considering seeking medical help for adverse events (3.1% v. 1.4%) (OR 2.18 [95% CI 1.39-3.41]). Interpretation: More than half of youth and young adults who had consumed energy drinks reported adverse outcomes, some serious enough to warrant seeking medical help. The adverse outcomes were consistent with the physiologic effects of caffeine but were significantly more prevalent than with other sources of caffeine such as coffee, consistent with data from national adverse event databases. PMID:29335277

Adverse effects of caffeinated energy drinks among youth and young adults in Canada: a Web-based survey.

PubMed

Hammond, David; Reid, Jessica L; Zukowski, Sara

2018-01-09

Energy drink consumption has increased dramatically among young Canadians, with anecdotal evidence of adverse health effects. There is a lack of population-based studies to examine the prevalence of adverse events from energy drinks, particularly among young people. The current study sought to assess adverse events from energy drinks among a population-based sample of youth and young adults in Canada. An online survey was conducted in 2015 with a national sample of youth (aged 12-17 yr) and young adults (aged 18-24 yr) recruited from a consumer panel. Respondents reported prior consumption of energy drinks as well as adverse outcomes, concurrent activities associated with the outcomes and whether medical attention was sought or considered. Adverse events from coffee were also assessed for comparison. Weighted analyses are reported. Of the 2055 respondents, 1516 (73.8%) reported having ever consumed an energy drink, and 1741 (84.7%) reported having ever consumed coffee (unweighted). Overall, 55.4% of respondents who had ever consumed an energy drink reported that they had experienced at least 1 adverse event, including fast heartbeat (24.7%), difficulty sleeping (24.1%), headache (18.3%), nausea/vomiting/diarrhea (5.1%), chest pain (3.6%) and seizures (0.2%); 3.1% had sought or had considered seeking medical help for an adverse event. The prevalence of reported adverse events was significantly greater among energy drink consumers than among coffee consumers (36.0%) (odds ratio [OR] 2.67 [95% confidence interval (CI) 2.01-2.56]), as was the proportion who reported seeking or considering seeking medical help for adverse events (3.1% v. 1.4%) (OR 2.18 [95% CI 1.39-3.41]). More than half of youth and young adults who had consumed energy drinks reported adverse outcomes, some serious enough to warrant seeking medical help. The adverse outcomes were consistent with the physiologic effects of caffeine but were significantly more prevalent than with other sources of caffeine such as coffee, consistent with data from national adverse event databases. Copyright 2018, Joule Inc. or its licensors.

The effect of customization and use of a fetal growth standard on the association between birthweight percentile and adverse perinatal outcome.

PubMed

Sovio, Ulla; Smith, Gordon C S

2018-02-01

It has been proposed that correction of offspring weight percentiles (customization) might improve the prediction of adverse pregnancy outcome; however, the approach is not accepted universally. A complication in the interpretation of the data is that the main method for calculation of customized percentiles uses a fetal growth standard, and multiple analyses have compared the results with birthweight-based standards. First, we aimed to determine whether women who deliver small-for-gestational-age infants using a customized standard differed from other women. Second, we aimed to compare the association between birthweight percentile and adverse outcome using 3 different methods for percentile calculation: (1) a noncustomized actual birthweight standard, (2) a noncustomized fetal growth standard, and (3) a fully customized fetal growth standard. We analyzed data from the Pregnancy Outcome Prediction study, a prospective cohort study of nulliparous women who delivered in Cambridge, UK, between 2008 and 2013. We used a composite adverse outcome, namely, perinatal morbidity or preeclampsia. Receiver operating characteristic curve analysis was used to compare the 3 methods of calculating birthweight percentiles in relation to the composite adverse outcome. We confirmed previous observations that delivering an infant who was small for gestational age (<10th percentile) with the use of a fully customized fetal growth standard but who was appropriate for gestational age with the use of a noncustomized actual birthweight standard was associated with higher rates of adverse outcomes. However, we also observed that the mothers of these infants were 3-4 times more likely to be obese and to deliver preterm. When we compared the risk of adverse outcome from logistic regression models that were fitted to the birthweight percentiles that were derived by each of the 3 predefined methods, the areas under the receiver operating characteristic curves were similar for all 3 methods: 0.56 (95% confidence interval, 0.54-0.59) fully customized, 0.56 (95% confidence interval, 0.53-0.59) noncustomized fetal weight standard, and 0.55 (95% confidence interval, 0.53-0.58) noncustomized actual birthweight standard. When we classified the top 5% of predicted risk as high risk, the methods that used a fetal growth standard showed attenuation after adjustment for gestational age, whereas the birthweight standard did not. Further adjustment for the maternal characteristics, which included weight, attenuated the association with the customized standard, but not the other 2 methods. The associations after full adjustment were similar when we compared the 3 approaches. The independent association between birthweight percentile and adverse outcome was similar when we compared actual birthweight standards and fetal growth standards and compared customized and noncustomized standards. Use of fetal weight standards and customized percentiles for maternal characteristics could lead to stronger associations with adverse outcome through confounding by preterm birth and maternal obesity. Copyright © 2017 Elsevier Inc. All rights reserved.

Work-related asthma, financial barriers to asthma care, and adverse asthma outcomes: asthma call-back survey, 37 states and District of Columbia, 2006 to 2008.

PubMed

Knoeller, Gretchen E; Mazurek, Jacek M; Moorman, Jeanne E

2011-12-01

Proper asthma management and control depend on patients having affordable access to healthcare yet financial barriers to asthma care are common. To examine associations of work-related asthma (WRA) with financial barriers to asthma care and adverse asthma outcomes. Cross-sectional, random-digit-dial survey conducted in 37 states and District of Columbia. A total of 27,927 ever-employed adults aged ≥18 years with current asthma. Prevalence ratios (PR) for the associations of WRA with financial barriers to asthma care and of WRA with adverse asthma outcomes stratified by financial barriers. Persons with WRA were significantly more likely than those with non-WRA to have at least 1 financial barrier to asthma care [PR, 1.66; 95% confidence interval (CI), 1.43-1.92]. Individuals with WRA were more likely to experience adverse asthma outcomes such as asthma attack (PR, 1.31; 95% CI, 1.22-1.40), urgent treatment for worsening asthma (PR, 1.57; 95% CI, 1.39-1.78), asthma-related emergency room visit (PR, 1.69; 95% CI, 1.41-2.03), and very poorly controlled asthma (PR, 1.54; 95% CI: 1.36-1.75). After stratifying for financial barriers to asthma care, the associations did not change. Financial barriers to asthma care should be considered in asthma management, and individuals with WRA are more likely to experience financial barriers. However, individuals with WRA are more likely to experience adverse asthma outcomes than individuals with non-WRA, regardless of financial barriers. Additional studies are needed to identify medical, behavioral, occupational, or environmental factors associated with adverse asthma outcomes among individuals with WRA.

The association of change in medication regimen and use of inappropriate medication based on beers criteria with adverse outcomes in Japanese long-term care facilities.

PubMed

Ishii, Shinya; Kojima, Taro; Ezawa, Kazuhiko; Higashi, Kentaro; Ikebata, Yukihiko; Takehisa, Yozo; Akishita, Masahiro

2017-04-01

To describe medication use including potentially inappropriate medication (PIM) and examine the association between adverse outcomes and patient factors including PIM use in Japanese elderly patients in long-term care facilities. This was a retrospective cohort study of 470 patients in 53 Geriatric Health Service Facilities and 44 Sanatorium Type Medical Care Facilities for the Elderly Requiring Long Term Care. Standardized forms were used to collect information including oral and parenteral medication use on admission, and 1 month and 3 months after admission. PIMs were determined by the 2003 or 2012 Beers criteria. Adverse outcomes were any medical events leading to emergency department transfer, hospitalization to acute care hospitals or death. A total of 2,227 oral medications and 197 parenteral medications were prescribed for 470 patients on admission. PIM exposure based on the 2003 and 2012 Beers criteria was observed in 11.9% and 37.5%, respectively. Adverse outcomes within 3 months after admission were observed in 8.9% of the entire cohort, and were associated with age, sex, facility type and number of parenteral medications on admission. Adverse outcomes between one and three months after admission were associated with age, sex, number of parenteral medications at one month, and a change in the number of oral and parenteral medications within one month after admission. PIM exposure was not associated with adverse outcomes in any models. Use of PIM was prevalent in long-term care facilities. Our findings support the importance of comprehensive assessment of medication regimens including parenteral medication. Geriatr Gerontol Int 2017; 17: 591-597. © 2016 Japan Geriatrics Society.

Elective induction versus spontaneous labour in Latin America

PubMed Central

Guerra, Gláucia Virgínia; Souza, João Paulo; Faúndes, Aníbal; Morais, Sirlei Siani; Gülmezoglu, Ahmet Metin; Passini, Renato; Parpinelli, Mary Angela; Carroli, Guillermo

2011-01-01

Abstract Objective To assess the frequency of elective induction of labour and its determinants in selected Latin America countries; quantify success in attaining vaginal delivery, and compare rates of caesarean and adverse maternal and perinatal outcomes after elective induction versus spontaneous labour in low-risk pregnancies. Methods Of 37 444 deliveries in women with low-risk pregnancies, 1847 (4.9%) were electively induced. The factors associated with adverse maternal and perinatal outcomes among cases of spontaneous and induced onset of labour were compared. Odds ratios for factors potentially associated with adverse outcomes were calculated, as were the relative risks of having an adverse maternal or perinatal outcome (both with their 95% confidence intervals). Adjustment using multiple logistic regression models followed these analyses. Findings Of 11 077 cases of induced labour, 1847 (16.7%) were elective. Elective inductions occurred in 4.9% of women with low-risk pregnancies (37 444). Oxytocin was the most common method used (83% of cases), either alone or combined with another. Of induced deliveries, 88.2% were vaginal. The most common maternal adverse events were: (i) a higher postpartum need for uterotonic drugs, (ii) a nearly threefold risk of admission to the intensive care unit; (iii) a fivefold risk of postpartum hysterectomy, and (iv) an increased need for anaesthesia/analgesia. Perinatal outcomes were satisfactory except for a 22% higher risk of delayed breastfeeding (i.e. initiation between 1 hour and 7 days postpartum). Conclusion Caution is mandatory when indicating elective labour induction because the increased risk of maternal and perinatal adverse outcomes is not outweighed by clear benefits. PMID:21897486

Is polypharmacy an independent risk factor for adverse outcomes after an emergency department visit?

PubMed

Salvi, Fabio; Rossi, Lorena; Lattanzio, Fabrizia; Cherubini, Antonio

2017-03-01

This study aimed at verifying the role of polypharmacy as an independent risk factor for adverse health outcomes in older emergency department (ED) patients. This was a large (n = 2057) sample of older ED patients (≥65 years) participating in an observational cohort study. Polypharmacy and excessive polypharmacy were defined as having 6-9 drug prescriptions and 10 or more drug prescriptions in the last 3 months, respectively. The total number of medication prescriptions was also available. Outcome measures were in-hospital mortality; 30-day ED return; ED revisit, hospital admission, and mortality at 6 months. Logistic and Cox regression models as well as receiver operating characteristic curves using the Youden index and the area under the curve were calculated. Polypharmacy and excessive polypharmacy were present in 624 (30.3 %) and 367 (17.8 %) subjects, respectively. The mean number of prescriptions in the last 3 months was 5.7 (range 0-25) drugs. Polypharmacy and, particularly, excessive polypharmacy were constantly and independently associated with worse outcomes. A cut-off of 6 had the highest value of the Youden Index in predicting the majority of the adverse outcomes considered. Polypharmacy and excessive polypharmacy are independent risk factors for adverse health outcomes after an ED visit. Further studies are needed to clarify whether drug related issues (such as non-compliance, inappropriate or suboptimal prescribing, adverse drug reactions, and drug-drug or drug-disease interactions) or underlying multimorbidity and disease severity, as well as clinical complexity and frailty, are responsible for the negative outcomes associated with polypharmacy.

Sex-Specific and Strain-Dependent Effects of Early Life Adversity on Behavioral and Epigenetic Outcomes

PubMed Central

Kundakovic, Marija; Lim, Sean; Gudsnuk, Kathryn; Champagne, Frances A.

2013-01-01

Early life adversity can have a significant long-term impact with implications for the emergence of psychopathology. Disruption to mother-infant interactions is a form of early life adversity that may, in particular, have profound programing effects on the developing brain. However, despite converging evidence from human and animal studies, the precise mechanistic pathways underlying adversity-associated neurobehavioral changes have yet to be elucidated. One approach to the study of mechanism is exploration of epigenetic changes associated with early life experience. In the current study, we examined the effects of postnatal maternal separation (MS) in mice and assessed the behavioral, brain gene expression, and epigenetic effects of this manipulation in offspring. Importantly, we included two different mouse strains (C57BL/6J and Balb/cJ) and both male and female offspring to determine strain- and/or sex-associated differential response to MS. We found both strain-specific and sex-dependent effects of MS in early adolescent offspring on measures of open-field exploration, sucrose preference, and social behavior. Analyses of cortical and hippocampal mRNA levels of the glucocorticoid receptor (Nr3c1) and brain-derived neurotrophic factor (Bdnf) genes revealed decreased hippocampal Bdnf expression in maternally separated C57BL/6J females and increased cortical Bdnf expression in maternally separated male and female Balb/cJ offspring. Analyses of Nr3c1and Bdnf (IV and IX) CpG methylation indicated increased hippocampal Nr3c1 methylation in maternally separated C57BL/6J males and increased hippocampal Bdnf IX methylation in male and female maternally separated Balb/c mice. Overall, though effect sizes were modest, these findings suggest a complex interaction between early life adversity, genetic background, and sex in the determination of neurobehavioral and epigenetic outcomes that may account for differential vulnerability to later-life disorder. PMID:23914177

Colchicine for primary prevention of atrial fibrillation after open-heart surgery: Systematic review and meta-analysis.

PubMed

Lennerz, Carsten; Barman, Manish; Tantawy, Mahmoud; Sopher, Mark; Whittaker, Peter

2017-12-15

Atrial fibrillation occurs frequently after open-heart surgery. It is associated with increased morbidity and mortality, longer hospital stays, and increased healthcare costs. Prophylactic administration of colchicine may mitigate post-operative atrial fibrillation (POAF). We searched PubMed, ClinicalTrials.gov and CENTRAL databases to identify randomized controlled trials (RCTs) that; (1) compared prophylactic use of colchicine to placebo, or usual care, in patients with sinus rhythm who underwent elective open-heart surgery and (2) reported POAF-incidence. We excluded trials focused on incidence of atrial fibrillation after percutaneous interventions or colchicine treatment of diagnosed pericarditis or post-pericardiotomy-syndrome. A random-effects model was used to pool data for POAF-incidence as the primary outcome and for drug-related adverse effects, major adverse events (death and stroke), and hospital length-of-stay as secondary outcomes. We included five RCTs (1412 patients). Colchicine treatment reduced POAF-events by 30% versus placebo or usual care (18% vs. 27%, risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.84, p=0.0002). Adverse drug-related effects, especially gastrointestinal intolerance, increased with colchicine; (21% vs. 8.2%, RR 2.52, 95% CI 1.62 to 3.93, p<0.0001). However, major adverse events were unchanged (3.2% vs. 3.2%, RR 0.96, 95% CI 0.48 to 1.95, p=0.92). Length-of-stay decreased by 1.2days with colchicine (95% CI -1.89 to -0.44, p=0.002). Colchicine demonstrated superior efficacy versus usual care for prevention of atrial fibrillation after cardiac surgery. Moreover, colchicine treatment was associated with shorter hospital stays. These benefits outweigh increased risk of adverse drug-related effects; although further work is needed to minimize gastrointestinal effects. Copyright © 2017 Elsevier B.V. All rights reserved.

Endocrine-disrupting activity of hydraulic fracturing chemicals and adverse health outcomes after prenatal exposure in male mice

USGS Publications Warehouse

Kassotis, Christopher D.; Klemp, Kara C.; Vu, Danh C.; Lin, Chung-Ho; Meng, Chun-Xia; Besch-Williford, Cynthia L.; Pinatti, Lisa; Zoeller, R. Thomas; Drobnis, Erma Z.; Balise, Victoria D.; Isiguzo, Chiamaka J.; Williams, Michelle A.; Tillitt, Donald E.; Nagel, Susan C.

2015-01-01

Oil and natural gas operations have been shown to contaminate surface and ground water with endocrine-disrupting chemicals. In the current study, we fill several gaps in our understanding of the potential environmental impacts related to this process. We measured the endocrine-disrupting activities of 24 chemicals used and/or produced by oil and gas operations for five nuclear receptors using a reporter gene assay in human endometrial cancer cells. We also quantified the concentration of 16 of these chemicals in oil and gas wastewater samples. Finally, we assessed reproductive and developmental outcomes in male C57BL/6J mice after the prenatal exposure to a mixture of these chemicals. We found that 23 commonly used oil and natural gas operation chemicals can activate or inhibit the estrogen, androgen, glucocorticoid, progesterone, and/or thyroid receptors, and mixtures of these chemicals can behave synergistically, additively, or antagonistically in vitro. Prenatal exposure to a mixture of 23 oil and gas operation chemicals at 3, 30, and 300 μg/kg · d caused decreased sperm counts and increased testes, body, heart, and thymus weights and increased serum testosterone in male mice, suggesting multiple organ system impacts. Our results suggest possible adverse developmental and reproductive health outcomes in humans and animals exposed to potential environmentally relevant levels of oil and gas operation chemicals.

Nutritional status and health outcomes for older people with dementia living in institutions.

PubMed

Lou, Meei-Fang; Dai, Yu-Tzu; Huang, Guey-Shiun; Yu, Po-Jui

2007-12-01

This paper is a report of a study to determine changes over a 3-month period among older people with dementia living in long-term care settings, related to: (1) changes in body mass index, and (2) health outcomes and associated factors. Nutritional deficiencies are common problems among older people, but frequently unrecognized, both in long-term care settings and in the community. A cross-sectional design with repeated measures of body weights and medical record reviews was adopted. The study was conducted in 2003 in two long-term care facilities for older people with dementia in Taiwan. Fifty-five residents participated in the study. Eighteen percent of the residents were under-nourished (body mass index <18.5). There was a trend toward decreasing body mass index over the 3-month study period. Residents with low body mass index tended to need assistance at mealtimes. Nineteen residents, many receiving naso-gastric tube-feeding, experienced adverse health events during the study period. Dependency in eating was the major factor differentiating residents with normal or low body mass index values, and also in distinguishing those who experienced adverse health outcomes. Assessment of eating ability, mode of feeding and measurement of body weight can be used by nurses in long-term care settings for early identification of the nutritional status of older people with dementia.

Decidual Cox2 inhibition improves fetal and maternal outcomes in a preeclampsia-like mouse model

PubMed Central

Sones, Jenny L.; Cha, Jeeyeon; Woods, Ashley K.; Bartos, Amanda; Heyward, Christa Y.; Lob, Heinrich E.; Isroff, Catherine E.; Butler, Scott D.; Shapiro, Stephanie E.; Dey, Sudhansu K.; Davisson, Robin L.

2016-01-01

Preeclampsia (PE) is a disorder of pregnancy that manifests as late gestational maternal hypertension and proteinuria and can be life-threatening to both the mother and baby. It is believed that abnormal placentation is responsible for the cascade of events leading to the maternal syndrome. Embryo implantation is critical to establishing a healthy pregnancy. Defective implantation can cause adverse “ripple effects,” leading to abnormal decidualization and placentation, retarded fetal development, and poor pregnancy outcomes, such as PE and fetal growth restriction. The precise mechanism(s) of implantation defects that lead to PE remain elusive. BPH/5 mice, which spontaneously develop the cardinal features of PE, show peri-implantation defects including upregulation of Cox2 and IL-15 at the maternal-fetal interface. This was associated with decreased decidual natural killer (dNK) cells, which have important roles in establishing placental perfusion. Interestingly, a single administration of a Cox2 inhibitor (celecoxib) during decidualization restrained Cox2 and IL-15 expression, restored dNK cell numbers, improved fetal growth, and attenuated late gestational hypertension in BPH/5 female mice. This study provides evidence that decidual overexpression of Cox2 and IL-15 may trigger the adverse pregnancy outcomes reflected in the preeclamptic syndrome, underscoring the idea that Cox2 inhibitor treatment is an effective strategy for the prevention of PE-associated fetal and maternal morbidity and mortality. PMID:27159542

Endocrine-Disrupting Activity of Hydraulic Fracturing Chemicals and Adverse Health Outcomes After Prenatal Exposure in Male Mice.

PubMed

Kassotis, Christopher D; Klemp, Kara C; Vu, Danh C; Lin, Chung-Ho; Meng, Chun-Xia; Besch-Williford, Cynthia L; Pinatti, Lisa; Zoeller, R Thomas; Drobnis, Erma Z; Balise, Victoria D; Isiguzo, Chiamaka J; Williams, Michelle A; Tillitt, Donald E; Nagel, Susan C

2015-12-01

Oil and natural gas operations have been shown to contaminate surface and ground water with endocrine-disrupting chemicals. In the current study, we fill several gaps in our understanding of the potential environmental impacts related to this process. We measured the endocrine-disrupting activities of 24 chemicals used and/or produced by oil and gas operations for five nuclear receptors using a reporter gene assay in human endometrial cancer cells. We also quantified the concentration of 16 of these chemicals in oil and gas wastewater samples. Finally, we assessed reproductive and developmental outcomes in male C57BL/6J mice after the prenatal exposure to a mixture of these chemicals. We found that 23 commonly used oil and natural gas operation chemicals can activate or inhibit the estrogen, androgen, glucocorticoid, progesterone, and/or thyroid receptors, and mixtures of these chemicals can behave synergistically, additively, or antagonistically in vitro. Prenatal exposure to a mixture of 23 oil and gas operation chemicals at 3, 30, and 300 μg/kg · d caused decreased sperm counts and increased testes, body, heart, and thymus weights and increased serum testosterone in male mice, suggesting multiple organ system impacts. Our results suggest possible adverse developmental and reproductive health outcomes in humans and animals exposed to potential environmentally relevant levels of oil and gas operation chemicals.

Defining Catastrophic Costs and Comparing Their Importance for Adverse Tuberculosis Outcome with Multi-Drug Resistance: A Prospective Cohort Study, Peru

PubMed Central

Wingfield, Tom; Boccia, Delia; Tovar, Marco; Gavino, Arquímedes; Zevallos, Karine; Montoya, Rosario; Lönnroth, Knut; Evans, Carlton A.

2014-01-01

Background Even when tuberculosis (TB) treatment is free, hidden costs incurred by patients and their households (TB-affected households) may worsen poverty and health. Extreme TB-associated costs have been termed “catastrophic” but are poorly defined. We studied TB-affected households' hidden costs and their association with adverse TB outcome to create a clinically relevant definition of catastrophic costs. Methods and Findings From 26 October 2002 to 30 November 2009, TB patients (n = 876, 11% with multi-drug-resistant [MDR] TB) and healthy controls (n = 487) were recruited to a prospective cohort study in shantytowns in Lima, Peru. Patients were interviewed prior to and every 2–4 wk throughout treatment, recording direct (household expenses) and indirect (lost income) TB-related costs. Costs were expressed as a proportion of the household's annual income. In poorer households, costs were lower but constituted a higher proportion of the household's annual income: 27% (95% CI = 20%–43%) in the least-poor houses versus 48% (95% CI = 36%–50%) in the poorest. Adverse TB outcome was defined as death, treatment abandonment or treatment failure during therapy, or recurrence within 2 y. 23% (166/725) of patients with a defined treatment outcome had an adverse outcome. Total costs ≥20% of household annual income was defined as catastrophic because this threshold was most strongly associated with adverse TB outcome. Catastrophic costs were incurred by 345 households (39%). Having MDR TB was associated with a higher likelihood of incurring catastrophic costs (54% [95% CI = 43%–61%] versus 38% [95% CI = 34%–41%], p<0.003). Adverse outcome was independently associated with MDR TB (odds ratio [OR] = 8.4 [95% CI = 4.7–15], p<0.001), previous TB (OR = 2.1 [95% CI = 1.3–3.5], p = 0.005), days too unwell to work pre-treatment (OR = 1.01 [95% CI = 1.00–1.01], p = 0.02), and catastrophic costs (OR = 1.7 [95% CI = 1.1–2.6], p = 0.01). The adjusted population attributable fraction of adverse outcomes explained by catastrophic costs was 18% (95% CI = 6.9%–28%), similar to that of MDR TB (20% [95% CI = 14%–25%]). Sensitivity analyses demonstrated that existing catastrophic costs thresholds (≥10% or ≥15% of household annual income) were not associated with adverse outcome in our setting. Study limitations included not measuring certain “dis-saving” variables (including selling household items) and gathering only 6 mo of costs-specific follow-up data for MDR TB patients. Conclusions Despite free TB care, having TB disease was expensive for impoverished TB patients in Peru. Incurring higher relative costs was associated with adverse TB outcome. The population attributable fraction indicated that catastrophic costs and MDR TB were associated with similar proportions of adverse outcomes. Thus TB is a socioeconomic as well as infectious problem, and TB control interventions should address both the economic and clinical aspects of this disease. Please see later in the article for the Editors' Summary PMID:25025331

Transplant Pulmonary Interventions: Translating Lung Transplant Interventions to Nontransplant Patients.

PubMed

Sinha, Neeraj

2016-01-01

Roughly 10% of lung transplant recipients experience airway complications. Although the incidence has decreased dramatically since the first lung transplants were performed in the 1960s, airway complications have continued to adversely affect outcomes. Bronchoscopic interventions such as balloon dilation, airway stenting, and endobronchial electrocautery play an important role in ameliorating the morbidity and mortality associated with these complications. This review describes the array of bronchoscopic interventions used to treat airway complications after lung transplant and how these techniques can be used in nontransplant settings as well.

Fish early life stage: Developing AOPs to support targeted reduction and replacement

EPA Science Inventory

There is an interest in developing alternatives to the fish early-life stage (FELS) test (OECD test guideline 210), for predicting adverse chronic toxicity outcomes (e.g., impacts on growth and survival). Development and characterization of adverse outcome pathways (AOPs) related...

Development of a Novel Quantitative Adverse Outcome Pathway Predictive Model for Lung Cancer

EPA Science Inventory

Traditional methods for carcinogenicity testing are resource-intensive, retrospective, and time consuming. An increasing testing burden has generated interest in the adverse outcome pathway (AOP) concept as a tool to evaluate chemical safety in a more efficient, rapid and effecti...

Proteomics for Adverse Outcome Pathway Discovery using Human Kidney Cells?

EPA Science Inventory

An Adverse Outcome Pathway (AOP) is a conceptual framework that applies molecular-based data for use in risk assessment and regulatory decision support. AOP development is based on effects data of chemicals on biological processes (i.e., molecular initiating events, key intermedi...

AOP-DB Frontend: A user interface for the Adverse Outcome Pathways Database.

EPA Science Inventory

The EPA Adverse Outcome Pathway Database (AOP-DB) is a database resource that aggregates association relationships between AOPs, genes, chemicals, diseases, pathways, species orthology information, ontologies. The AOP-DB frontend is a simple yet powerful AOP-DB user interface in...

AOP-DB Frontend: A user interface for the Adverse Outcome Pathways Database

EPA Science Inventory

The EPA Adverse Outcome Pathway Database (AOP-DB) is a database resource that aggregates association relationships between AOPs, genes, chemicals, diseases, pathways, species orthology information, ontologies. The AOP-DB frontend is a simple yet powerful user interface in the for...

Using Adverse Outcome Pathways to Build Chemical Groups: A Case Study for Hepatic Steatosis

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework systematically documents the mechanisms underlying effects of chemicals. Ideally, the AOP traces the mechanism to the initial interaction of chemicals with the biological system. Thus, AOPs should help inform chemical grouping by identi...

Use of an Adverse Outcome Pathway for Hepatic Steatosis to Build Chemical Groups

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework systematically documents the mechanisms underlying effects of chemicals starting with the initial interaction of chemicals with the biological system, i.e. the molecular initiating event (MIE). Chemical activity in assays designed to mo...

Use of Adverse Outcome Pathways to Inform Decisions on Chemical Innovation, Regulation & Stewardship

EPA Science Inventory

An invited group of scientists participated in a SETAC Pellston WorkshopTM, “Advancing the Adverse Outcome Pathway (AOP) Concept – An International Horizon Scanning Approach,” in April 2017. The workshop addressed key challenges or limitations of AOP constructs...

Tipping the Balance: Hepatotoxicity and the Four Apical Key Events of Hepatic Steatosis

EPA Science Inventory

Adverse outcome pathways (AOPs) are descriptive biological sequences that start from a molecular initiating event (MIE) and end with an adverse health outcome. AOPs provide biological context for high throughput chemical testing and further prioritize environmental health risk r...

The adverse outcome pathway: A multifaceted framework supporting 21st century toxicology

EPA Science Inventory

The adverse outcome pathway (AOP) framework serves as a knowledge assembly, interpretation, and communication tool designed to support the translation of pathway-specific mechanistic data into responses relevant to assessing and managing risks of chemicals to human health and the...

Exposure and Dosimetry Considerations for Adverse Outcome Pathways (AOPs) (NIH-AOP)

EPA Science Inventory

Risk is a function of both of hazard and exposure. Toxicokinetic (TK) models can determine whether chemical exposures produce potentially hazardous tissue concentrations. Whether or not the initial molecular event (MIE) in an Adverse Outcome Pathway (AOP) occurs depends on both e...

Constructing Adverse Outcome Pathways: a Demonstration of an Ontology-based Semantics Mapping Approach

EPA Science Inventory

Adverse outcome pathway (AOP) provides a conceptual framework to evaluate and integrate chemical toxicity and its effects across the levels of biological organization. As such, it is essential to develop a resource-efficient and effective approach to extend molecular initiating ...

Intersections of poverty, race/ethnicity, and sex: alcohol consumption and adverse outcomes in the United States.

PubMed

Glass, Joseph E; Rathouz, Paul J; Gattis, Maurice; Joo, Young Sun; Nelson, Jennifer C; Williams, Emily C

2017-05-01

We examine whether intersectionality theory-which formalizes the notion that adverse health outcomes owing to having a marginalized social status, identity, or characteristic, may be magnified for individuals with an additional marginalized social status, identity, or characteristic-can be applied using quantitative methods to describe the differential effects of poverty on alcohol consumption across sex and race/ethnicity. Using the National Epidemiologic Survey on Alcohol and Related Conditions, we analyze longitudinal data from Black, Hispanic, and White drinkers (n = 21,140) to assess multiplicative interactions between poverty, as defined by the US Census Bureau, sex, and race/ethnicity, on adverse alcohol outcomes. Findings indicated that the effect of poverty on the past-year incidence of heavy episodic drinking was stronger among Black men and Black women in comparison to men and women of other racial/ethnic groups. Poverty reduction programs that are culturally informed may help reduce racial/ethnic disparities in the adverse outcomes of alcohol consumption.

Intersections of poverty, race/ethnicity, and sex: Alcohol consumption and adverse outcomes in the United States

PubMed Central

Glass, Joseph E.; Rathouz, Paul J.; Gattis, Maurice; Joo, Young Sun; Nelson, Jennifer C.; Williams, Emily C.

2017-01-01

We examine whether intersectionality theory—which formalizes the notion that adverse health outcomes owing to having a marginalized social status, identity, or characteristic, may be magnified for individuals with an additional marginalized social status, identity, or characteristic —can be applied using quantitative methods to describe the differential effects of poverty on alcohol consumption across sex and race/ethnicity. Using the National Epidemiologic Survey on Alcohol and Related Conditions, we analyze longitudinal data from Black, Hispanic, and White drinkers (n = 21,140) to assess multiplicative interactions between poverty, as defined by the U.S. Census Bureau, sex, and race/ethnicity, on adverse alcohol outcomes. Findings indicated that the effect of poverty on the past-year incidence of heavy episodic drinking was stronger among Black men and Black women in comparison to men and women of other racial/ethnic groups. Poverty reduction programs that are culturally informed may help reduce racial/ethnic disparities in the adverse outcomes of alcohol consumption. PMID:28349171

Impact of hydroxychloroquine on preterm delivery and intrauterine growth restriction in pregnant women with systemic lupus erythematosus: a descriptive cohort study.

PubMed

Leroux, M; Desveaux, C; Parcevaux, M; Julliac, B; Gouyon, J B; Dallay, D; Pellegrin, J L; Boukerrou, M; Blanco, P; Lazaro, E

2015-11-01

The aim of this study was to evaluate the effect of hydroxychloroquine (HCQ) on fetal preterm delivery and intrauterine growth restriction (IUGR) in a cohort of pregnant women with systemic lupus erythematosus (SLE). Over an 11-year period (January 1, 2001 to December 31, 2011), all women with SLE and admitted to deliver after 22 weeks of gestation to Bordeaux University Hospital (France), were retrospectively enrolled in the present study. The population was then split into two groups based on the treatment they received: HCQ exposed (HCQ+) versus HCQ non-exposed (HCQ-) group. 118 pregnancies were included, 41 in the HCQ+ group and 77 in the HCQ- group. The rate of adverse fetal outcome was significantly lower in the HCQ+ group (p = 0.001), particularly in terms of preterm delivery, 15.8% versus 44.2% (p = 0.006), and IUGR, 10.5% versus 28.6% (p = 0.03). No adverse outcomes were reported in the HCQ+ group. HCQ reduces neonatal morbidity in women with SLE by significantly decreasing the rate of prematurity and intrauterine growth restriction. © The Author(s) 2015.

The long arm of community: the influence of childhood community contexts across the early life course.

PubMed

Wickrama, K A S; Noh, Samuel

2010-08-01

This study examines the longitudinal effects of childhood community contexts on young adult outcomes. The study uses a sample of 14,000 adolescents (52% female) derived from the 1990 US Census and the National Longitudinal Study of Adolescent Health (Addhealth). The study examines whether community and family environments exert separate and/or joint long-term influences on young adult achievement and depression. We found both direct and indirect long-term influences of childhood community adversity on young adult educational attainment. The indirect influences of childhood community adversity operated through family and individual-level factors. The long-term influence of childhood community adversity on young adult depression was only indirect. Overall, community influences on young adult achievement outcomes were mediated by family context and by the adolescents' adjustments and transitions, including adolescent depression, school adjustment, and disruptive transitional events. The moderating effect of childhood community adversity suggests that the protective effects of family resources on young adult outcomes dissipate significantly in extremely adverse neighborhoods. The findings demonstrate the importance of integrating multiple theoretical perspectives for longitudinal research to capture pathways of community influence on adolescent developmental and young adulthood outcomes.

Male gender and renal dysfunction are predictors of adverse outcome in nonpostoperative ischemic colitis patients.

PubMed

Lee, Tsung-Chun; Wang, Hsiu-Po; Chiu, Han-Mo; Lien, Wan-Ching; Chen, Mei-Jyh; Yu, Linda C H; Sun, Chia-Tung; Lin, Jaw-Town; Wu, Ming-Shiang

2010-01-01

Ischemic colitis (IC) spans a broad spectrum from self-limiting illness to intestinal gangrene and mortality. Prognostic factors specifically for nonpostoperative IC were not fully characterized. We aim to focus on nonpostoperative IC in patients with renal dysfunction and try to identify prognostic factors for adverse outcomes. We conducted a retrospective analysis at a university-affiliated tertiary medical center in Taiwan. From January 2003 to August 2008, 25 men and 52 women (mean age: 66 y) had colonoscopic biopsy-proven IC without prior culprit surgery. We estimated glomerular filtration rate with simplified Modification of Diet in Renal Disease equation. Nine patients with glomerular filtration rate below 30 mL per minute per 1.73 m were classified as renal dysfunction group (including 7 dialysis patients). Adverse outcomes were defined as need for surgery and mortality. Predictors for adverse outcomes were captured by univariate and multivariate analysis. Research ethical committee approved the study protocol. Patients with renal dysfunction more often had: diabetes mellitus (56% vs. 16%, P=0.02), prolonged symptoms (6.8 d vs. 3.5 d, P=0.01), lower hemoglobin (11.1 g/dL vs. 13.4 g/dL, P=0.01), and more often right colonic involvement (56% vs. 19%, P=0.03). Renal dysfunction patients also had longer hospitalization days (median 15 d vs. 4 d, P=0.045). However, there was no statistical significance in the rate of either surgery or mortality between these 2 groups (P>0.05). Univariate analysis showed that renal dysfunction, sex, emergency department referral, presentation with abdominal pain were significant for adverse outcome (P<0.1). Multivariate analysis revealed that male sex conveyed 9.5-fold risk (P=0.01) and renal dysfunction conveyed 8.5-fold risk (P=0.03) for adverse outcomes. Nonpostoperative IC patients with concurrent renal dysfunction had distinct clinical profiles. Multivariate analysis showed that male patients had 9.5-fold and renal dysfunction patients had 8.5-fold increased risk for adverse outcomes. Although IC is often self-limited, our data warrants special attention and aggressive therapy in treating these patients.

Applying adverse outcome pathways and species sensitivity-weighted distribution to predicted-no-effect concentration derivation and quantitative ecological risk assessment for bisphenol A and 4-nonylphenol in aquatic environments: A case study on Tianjin City, China.

PubMed

Wang, Ying; Na, Guangshui; Zong, Humin; Ma, Xindong; Yang, Xianhai; Mu, Jingli; Wang, Lijun; Lin, Zhongsheng; Zhang, Zhifeng; Wang, Juying; Zhao, Jinsong

2018-02-01

Adverse outcome pathways (AOPs) are a novel concept that effectively considers the toxic modes of action and guides the ecological risk assessment of chemicals. To better use toxicity data including biochemical or molecular responses and mechanistic data, we further developed a species sensitivity-weighted distribution (SSWD) method for bisphenol A and 4-nonylphenol. Their aquatic predicted-no-effect concentrations (PNECs) were derived using the log-normal statistical extrapolation method. We calculated aquatic PNECs of bisphenol A and 4-nonylphenol with values of 4.01 and 0.721 µg/L, respectively. The ecological risk of each chemical in different aquatic environments near Tianjin, China, a coastal municipality along the Bohai Sea, was characterized by hazard quotient and probabilistic risk quotient assessment techniques. Hazard quotients of 7.02 and 5.99 at 2 municipal sewage sites using all of the endpoints were observed for 4-nonylphenol, which indicated high ecological risks posed by 4-nonylphenol to aquatic organisms, especially endocrine-disrupting effects. Moreover, a high ecological risk of 4-nonylphenol was indicated based on the probabilistic risk quotient method. The present results show that combining the SSWD method and the AOP concept could better protect aquatic organisms from adverse effects such as endocrine disruption and could decrease uncertainty in ecological risk assessment. Environ Toxicol Chem 2018;37:551-562. © 2017 SETAC. © 2017 SETAC.

Adverse nurse outcomes: correlation to nurses' workload, staffing, and shift rotation in Kuwaiti hospitals.

PubMed

Al-Kandari, Fatimah; Thomas, Deepa

2008-08-01

This study was conducted to identify adverse outcomes to nurses in relation to their daily patient load, nursing care activities, staffing, and shift rotation. A structured questionnaire was used to collect data from medical and surgical nurses (N = 784). Skipping tea/coffee breaks (95%), feeling responsible for more patients than they could safely care for (87%), inadequate help available (86%), inadequate time to document care (80%), verbal abuse by a patient or a visitor (77%), and concern about quality of care (71%) were the major reported adverse outcomes related to short staffing, increased patient load, and increased nursing care activities.

Extreme umbilical cord lengths, cord knot and entanglement: Risk factors and risk of adverse outcomes, a population-based study

PubMed Central

Kessler, Jörg

2018-01-01

Objectives To determine risk factors for short and long umbilical cord, entanglement and knot. Explore their associated risks of adverse maternal and perinatal outcome, including risk of recurrence in a subsequent pregnancy. To provide population based gestational age and sex and parity specific reference ranges for cord length. Design Population based registry study. Setting Medical Birth Registry of Norway 1999–2013. Population All singleton births (gestational age>22weeks<45 weeks) (n = 856 300). Methods Descriptive statistics and odds ratios of risk factors for extreme cord length and adverse outcomes based on logistic regression adjusted for confounders. Main outcome measures Short or long cord (<10th or >90th percentile), cord knot and entanglement, adverse pregnancy outcomes including perinatal and intrauterine death. Results Increasing parity, maternal height and body mass index, and diabetes were associated with increased risk of a long cord. Large placental and birth weight, and fetal male sex were factors for a long cord, which again was associated with a doubled risk of intrauterine and perinatal death, and increased risk of adverse neonatal outcome. Anomalous cord insertion, female sex, and a small placenta were associated with a short cord, which was associated with increased risk of fetal malformations, placental complications, caesarean delivery, non-cephalic presentation, perinatal and intrauterine death. At term, cord knot was associated with a quadrupled risk of perinatal death. The combination of a cord knot and entanglement had a more than additive effect to the association to perinatal death. There was a more than doubled risk of recurrence of a long or short cord, knot and entanglement in a subsequent pregnancy of the same woman. Conclusion Cord length is influenced both by maternal and fetal factors, and there is increased risk of recurrence. Extreme cord length, entanglement and cord knot are associated with increased risk of adverse outcomes including perinatal death. We provide population based reference ranges for umbilical cord length. PMID:29584790

Adverse cardiovascular outcomes between insulin-treated and non-insulin treated diabetic patients after percutaneous coronary intervention: a systematic review and meta-analysis.

PubMed

Bundhun, Pravesh Kumar; Li, Nuo; Chen, Meng-Hua

2015-10-07

Type 2 diabetes mellitus (DM) patients have worse adverse cardiovascular outcomes after Percutaneous Coronary Intervention (PCI). However, the adverse cardiovascular outcomes between insulin-treated and non-insulin treated DM patients have been a subject of debate. We sought to compare the short-term (<1 year) and long-term (≥1 year) cardiovascular outcomes between insulin-treated and non-insulin treated DM patients after PCI. Medline and Embase databases were searched for studies by typing 'diabetes and percutaneous coronary intervention/PCI' or 'insulin-treated and non-insulin treated diabetes mellitus and PCI'. Endpoints included adverse cardiovascular outcomes reported in these DM patients during the corresponding follow-up periods. Odd Ratio (OR) with 95% confidence interval (CI) was used to express the pooled effect on discontinuous variables and the pooled analyses were performed with RevMan 5.3. 21 studies have been included in this meta-analysis consisting of a total of 21,759 diabetic patients (6250 insulin-treated and 15,509 non-insulin treated DM patients). Short term mortality, myocardial infarction, target lesion revascularization, major adverse cardiac effects and, stent thrombosis were significantly higher in insulin-treated diabetic patients (OR 1.69, 95% CI 1.40-2.04, p < 0.00001), (OR 1.40, 95% CI 1.16-1.70, p = 0.0005), (OR 1.37, 95% CI 1.06-1.76, p = 0.02), (OR 1.46, 95% CI 1.22-1.76, p < 0.0001) and (OR 1.66, 95% CI 1.16-2.38, p = 0.005) respectively. Long-term cardiovascular outcomes were also significantly higher in insulin-treated DM patients. Insulin treatment in these DM patients was associated with a significantly higher short and long-term adverse cardiovascular outcomes after PCI compared to those DM patients not treated by insulin therapy.

Travel time from home to hospital and adverse perinatal outcomes in women at term in the Netherlands.

PubMed

Ravelli, A C J; Jager, K J; de Groot, M H; Erwich, J J H M; Rijninks-van Driel, G C; Tromp, M; Eskes, M; Abu-Hanna, A; Mol, B W J

2011-03-01

To study the effect of travel time, at the start or during labour, from home to hospital on mortality and adverse outcomes in pregnant women at term in primary and secondary care. Population-based cohort study from 2000 up to and including 2006. The Netherlands Perinatal Registry. A total of 751,926 singleton term hospital births. We assessed the impact of travel time by car, calculated from the postal code of the woman's residence to the 99 maternity units, on neonatal outcome. Logistic regression modelling with adjustments for gestational age, maternal age, parity, ethnicity, socio-economic status, urbanisation, tertiary care centres and volume of the hospital was used. Mortality (intrapartum, and early and late neonatal mortality) and adverse neonatal outcomes (mortality, Apgar <4 and/or admission to a neonatal intensive care unit). The mortality was 1.5 per 1000 births, and adverse outcomes occurred in 6.0 per 1000 births. There was a positive relationship between longer travel time (≥20 minutes) and total mortality (OR 1.17, 95% CI 1.002-1.36), neonatal mortality within 24 hours (OR 1.51, 95% CI 1.13-2.02) and with adverse outcomes (OR 1.27, 95% CI 1.17-1.38). In addition to travel time, both delivery at 37 weeks of gestation (OR 2.23, 95% CI 1.81-2.73) or 41 weeks of gestation (OR 1.52, 95% CI 1.29-1.80) increased the risk of mortality. A travel time from home to hospital of 20 minutes or more by car is associated with an increased risk of mortality and adverse outcomes in women at term in the Netherlands. These findings should be considered in plans for the centralisation of obstetric care. © 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.

Patient-Reported Disease Activity and Adverse Pregnancy Outcomes in Systemic Lupus Erythematosus and Rheumatoid Arthritis.

PubMed

Harris, Nathaniel; Eudy, Amanda; Clowse, Megan

2018-06-15

While increased rheumatic disease activity during pregnancy has been associated with adverse pregnancy outcomes, this activity is typically assessed by the physician. Little is known, however, about the association between patient-reported measures of disease activity and pregnancy outcomes. Univariate and multivariable regression models were used to assess the relationship between patient and physician-reported measures of disease activity and adverse pregnancy outcomes in 225 patients with lupus or rheumatoid arthritis (RA) enrolled in a prospective registry at a single academic center from 2008-2016. In women with RA, patient-reported disease activity is associated with preterm birth (OR 5.9 (1.5-23.9)), and gestational age (beta -1.5 weeks (-2.6, -0.4 weeks)). The physician assessment of disease activity also predicted preterm (OR 2.1 (1.2-3.5)), small for gestational age births (OR 1.8 (1.03-3.1), and gestational age in weeks (beta -0.6 weeks (-0.9, -0.02 weeks)). On the other hand, SLE patient-reported disease activity measures, including the HAQ, pain or global health measures, are not associated with adverse pregnancy outcomes. However, physician measures of SLE disease activity are associated with preterm birth (OR 2.9 (1.-6.3)), cesarean delivery (OR 2.3 (1.0-5.3)), and preeclampsia (OR 2.8 (1.3-6.3)). The results do not appear to be driven by lupus nephritis or antiphospholipid syndrome. For women with RA, patient-reported measures of disease activity may be useful adjuncts to physician-reported measures in identifying pregnancies at greater risk. In contrast, in SLE, no patient-reported measures were associated with adverse outcomes while physician measures of disease activity helped predict several adverse pregnancy outcomes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Associations between maternal lipid profile and pregnancy complications and perinatal outcomes: a population-based study from China.

PubMed

Jin, Wen-Yuan; Lin, Sheng-Liang; Hou, Ruo-Lin; Chen, Xiao-Yang; Han, Ting; Jin, Yan; Tang, Li; Zhu, Zhi-Wei; Zhao, Zheng-Yan

2016-03-21

Dyslipidemia in pregnancy are associated with gestational diabetes mellitus (GDM), preeclampsia, preterm birth and other adverse outcomes, which has been extensively studied in western countries. However, similar studies have rarely been conducted in Asian countries. Our study was aimed at investigating the associations between maternal dyslipidemia and adverse pregnancy outcomes among Chinese population. Data were derived from 934 pairs of non-diabetic mothers and neonates between 2010 and 2011. Serum blood samples were assayed for fasting total cholesterol (TC), triglycerides (TG), high-density lipoprotein-cholesterol (HDL-C), and low-density lipoprotein-cholesterol (LDL-C) concentrations during the first, second and third trimesters. The present study explored the associations between maternal lipid profile and pregnancy complications and perinatal outcomes. The pregnancy complications included GDM, preeclampsia and intrahepatic cholestasis of pregnancy (ICP); the perinatal outcomes included preterm birth, small/large for gestational age (SGA/LGA) infants and macrosomia. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated and adjusted via stepwise logistic regression analysis. Optimal cut-off points were determined by ROC curve analysis. After adjustments for confounders, every unit elevation in third-trimester TG concentration was associated with increased risk for GDM (OR = 1.37, 95% CI: 1.18-1.58), preeclampsia (OR = 1.50, 95% CI: 1.16-1.93), ICP (OR = 1.28, 95% CI: 1.09-1.51), LGA (OR = 1.13, 95% CI: 1.02-1.26), macrosomia (OR = 1.19, 95% CI: 1.02-1.39) and decreased risk for SGA (OR = 0.63, 95% CI: 0.40-0.99); every unit increase in HDL-C concentration was associated with decreased risk for GDM and macrosomia, especially during the second trimester (GDM: OR = 0.10, 95% CI: 0.03-0.31; macrosomia: OR = 0.25, 95% CI: 0.09-0.73). The optimal cut-off points for third-trimester TG predicting GDM, preeclampsia, ICP, LGA and SGA were separately ≥ 3.871, 3.528, 3.177, 3.534 and ≤ 2.530 mmol/L. The optimal cut-off points for third-trimester HDL-C identifying GDM, macrosomia and SGA were respectively ≤ 1.712, 1.817 and ≥ 2.238 mmol/L. Among Chinese population, maternal high TG in late pregnancy was independently associated with increased risk of GDM, preeclampsia, ICP, LGA, macrosomia and decreased risk of SGA. Relative low maternal HDL-C during pregnancy was significantly associated with increased risk of GDM and macrosomia; whereas relative high HDL-C was a protective factor for both of them.

Adverse outcome pathways linked to population models as a methodology for investigating effects of chemical stressors

EPA Science Inventory

In addressing the complexity and toxicity of chemical contaminants in Great Lakes ecosystems, we describe an approach to link chemically induced alterations in molecular and biochemical endpoints to adverse outcomes in whole organisms and populations. Analysis of population impac...

Empirical testing AOP network-based hazard prediction combined effect of aromatase inhibition & androgen receptor agonism

EPA Science Inventory

Adverse outcome pathways (AOPs) describe linkages between a specific molecular perturbation resulting from interaction of a chemical with a biomolecule in an organism and one possible adverse outcome of regulatory significance. While individual AOPs have utility, it is recognized...

Defining Adverse Outcome Pathways for Effects of the Fungicide Propiconazole of Fish Reproduction

EPA Science Inventory

Adverse outcome pathways (AOPs) are used to describe the linkage of chemical interactions in terms of molecular initiating events to whole organism responses suitable for risk assessment. This study was conducted to develop AOPs for the model fungicide propiconazole relative to r...

Application of the adverse outcome pathway framework - advances and challenges

EPA Science Inventory

The adverse outcome pathway (AOP) framework, while not new in concept, has gained attention in recent years as a set of organizing principles and tools that can help facilitate greater use of mechanistic or pathway-based data in risk assessment and regulatory decision-making. Reg...

Linking mechanistic data to endpoints of regulatory concern using the adverse outcome pathway framework.

EPA Science Inventory

In order to increase the uptake and use of high throughput screening data in environmental risk assessment, it is important to establish scientifically credible links between measures of biological pathway perturbation and apical adverse outcomes in humans and wildlife. The adver...

Creating a Structured Adverse Outcome Pathway Knowledgebase via Ontology-Based Annotations

EPA Science Inventory

The Adverse Outcome Pathway (AOP) framework is increasingly used to integrate data based on traditional and emerging toxicity testing paradigms. As the number of AOP descriptions has increased, so has the need to define the AOP in computable terms. Herein, we present a comprehens...

Use of the adverse outcome pathway framework to represent cross-species consequences of specific pathway perturbations

EPA Science Inventory

The adverse outcome pathway (AOP) framework has been developed as a means for assembling scientifically defensible descriptions of how particular molecular perturbations, termed molecular initiating events (MIEs), can evoke a set of predictable responses at different levels of bi...

A conceptual framework to advance exposure science research and complement the Adverse Outcome Pathway framework

EPA Science Inventory

A tremendous amount of data on environmental stressors has been accumulated in exposure science, epidemiology, and toxicology, yet most of these data reside in different silos. The Adverse Outcome Pathway (AOP) framework was developed as an organizing principle for toxicological ...

Quantitative Adverse Outcome Pathway for Neurodevelopmental Effects of Thyroid Peroxidase-Induced Thyroid Hormone Synthesis Inhibition

EPA Science Inventory

Adequate levels of thyroid hormones (TH) are needed for proper brain development and deficiencies lead to adverse neurological outcomes in humans and in animal models. Environmental chemicals have been shown to disrupt TH levels, yet the relationship between developmental exposur...

An exploratory study of whether pregnancy outcomes influence maternal self-reported history of child maltreatment.

PubMed

Cammack, Alison L; Hogue, Carol J; Drews-Botsch, Carolyn D; Kramer, Michael R; Pearce, Brad D; Knight, Bettina; Stowe, Zachary N; Newport, D Jeffrey

2018-02-22

Childhood maltreatment is common and has been increasingly studied in relation to perinatal outcomes. While retrospective self-report is convenient to use in studies assessing the impact of maltreatment on perinatal outcomes, it may be vulnerable to bias. We assessed bias in reporting of maltreatment with respect to women's experiences of adverse perinatal outcomes in a cohort of 230 women enrolled in studies of maternal mental illness. Each woman provided a self-reported history of childhood maltreatment via the Childhood Trauma Questionnaire at two time points: 1) the preconception or prenatal period and 2) the postpartum period. While most women's reports of maltreatment agreed, there was less agreement for physical neglect among women experiencing adverse perinatal outcomes. Further, among women who discrepantly reported maltreatment, those experiencing adverse pregnancy outcomes tended to report physical neglect after delivery but not before, and associations between physical neglect measured after delivery and adverse pregnancy outcomes were larger than associations that assessed physical neglect before delivery. There were larger associations between post-delivery measured maltreatment and perinatal outcomes among women who had not previously been pregnant and in those with higher postpartum depressive symptoms. Although additional larger studies in the general population are necessary to replicate these findings, they suggest retrospective reporting of childhood maltreatment, namely physical neglect, may be prone to systematic differential recall bias with respect to perinatal outcomes. Measures of childhood maltreatment reported before delivery may be needed to validly estimate associations between maternal exposure to childhood physical neglect and perinatal outcomes. Copyright © 2018 Elsevier Ltd. All rights reserved.

Preventive induction of labor for non-urgent indications at term and maternal and neonatal outcomes.

PubMed

Zhang, Lin; Zhang, Hao; Zhang, Jun; Zhang, Jin Wen; Ye, Jiang Feng; Branch, D Ware

2016-04-21

Induction of labor (IOL) is a common practice in many parts of the world. However, the benefits and risks of preventive IOL for the mother and baby have yet to be critically assessed. This study is to investigate the effects of preventive IOL for non-urgent indications at term on maternal and neonatal outcomes. In this study, we applied a propensity score model to mimic a randomized clinical trial. Maternal and neonatal outcomes were compared between women with preventive IOL at 37-39 weeks of gestation and women with ongoing pregnancy (expectant management). The subjects were from the Consortium on Safe Labor, a study of over 200,000 births from 19 hospitals across the US from 2002 to 2008. Both nulliparous and multiparous women induced preventively for non-urgent indications at 37-38 weeks' gestation had lower rates of cesarean delivery compared to those delivered at later gestational weeks. However, preventive IOL was associated with increased risks of adverse neonatal outcomes (adjusted odds ratio [aOR] = 1.68, 95% confidence interval [CI], 0.97-2.92 for nulliparas; aOR = 2.22, 1.32-3.74 for multiparas) and admission to NICU (aOR = 1.48, 0.99-2.20 for nulliparas; aOR = 2.08, 1.47-2.96 for multiparas) at 37 weeks' gestation. A longer maternal hospital stay was found among all women with preventive IOL. Preventive IOL for non-urgent indications may be associated with a decreased risk of cesarean delivery at early term but increased risks of adverse neonatal outcomes at 37 weeks. It also results in a longer hospital stay than expectant management.

Impact of perioperative nutritional status on the outcome of abdominal surgery in a sub-Saharan Africa setting.

PubMed

Mambou Tebou, Christian Gael; Temgoua, Mazou N; Esiene, Agnès; Nana, Blondel Oumarou; Noubiap, Jean Jacques; Sobngwi, Eugène

2017-09-18

Malnutrition is a clinical condition of multifactorial etiologies and it is associated with several adverse outcomes. In high-income countries, malnutrition has been described as a determinant of delayed wound healing, surgical site infections and mortality in the postoperative period. There is limited information available regarding the outcome of surgery in malnourished patients in sub-Saharan Africa. A cross-sectional analytic study was carried out between March and August 2014 in the visceral surgery and the emergency departments of the Yaounde Central Hospital in Cameroon. All consecutive consenting preoperative and postoperative patients of abdominal surgical procedures were enrolled. Variables studied were: socio-demographic characteristics, medical and surgical past histories, nutritional survey, anthropometric parameters and serum albumin level in order to determine the nutritional risk index (or Buzby score). A total of 85 patients aged from 19 to 50 years with mean age of 34.4 ± 8 years were included. The most performed abdominal surgical procedure was appendectomy (30.6%). The prevalence of preoperative malnutrition according to the Buzby score was 39.1%. Mean postoperative weight lost was 2.9 ± 1.2 kg and mean decrease in postoperative serum albumin was 4.2 ± 0.2 g. A normal postoperative serum albumin was associated with a favorable outcome [OR (95% CI) = 55 (13.4-224.3), p < 0.001]. The prevalence of malnutrition is high in our visceral surgery and emergency departments; this is associated with an increased risk of adverse early postoperative outcomes. Overall, our results emphasize the need of optimizing perioperative care through routine nutritional assessment and management of surgical patients in Cameroon.

Emergency transportation interventions for reducing adverse pregnancy outcomes in low- and middle-income countries: a systematic review protocol.

PubMed

Ehiri, John; Alaofè, Halimatou; Asaolu, Ibitola; Chebet, Joy; Esu, Ekpereonne; Meremikwu, Martin

2018-04-25

Transportation interventions seek to decrease delay in reaching a health facility for emergency obstetric care and are, thus, believed to contribute to reductions in such adverse pregnancy and childbirth outcomes as maternal deaths, stillbirths, and neonatal mortality in low- and middle-income countries (LMICs). However, there is limited empirical evidence to support this hypothesis. The objective of the proposed review is to summarize and critically appraise evidence regarding the effect of emergency transportation interventions on outcomes of labor and delivery in LMICs. The following databases will be searched from inception to March 31, 2018: MEDLINE/PubMed, EMBASE, Web of Science, EBSCO (PsycINFO and CINAHL), the Cochrane Pregnancy and Child Birth Group's Specialized Register, and the Cochrane Central Register of Controlled Trials. We will search for studies in the grey literature through Google and Google Scholar. We will solicit unpublished reports from such relevant agencies as United Nations Fund for Population Activities (UNFPA), the World Health Organization (WHO), the United Nations Children's Fund (UNICEF), the United States Agency for International Development (USAID), and the United Kingdom Department for International Development (DfID) among others. Data generated from the search will be managed using Endnote Version 7. We will perform quantitative data synthesis if studies are homogenous in characteristics and provide adequate outcome data for meta-analysis. Otherwise, data will be synthesized, using the narrative synthesis approach. Among the many barriers that women in LMICs face in accessing life-saving interventions during labor and delivery, lack of access to emergency transportation is particularly important. This review will provide a critical summary of evidence regarding the impact of transportation interventions on outcomes of pregnancy and childbirth in LMICs. PROSPERO CRD42017080092.

Tachydysrhythmia treatment and adverse events in patients with wolff-Parkinson-white syndrome.

PubMed

Siegelman, Jeffrey N; Marill, Keith A; Adler, Jonathan N

2014-09-01

Current guidelines recommend avoiding atrioventricular-nodal blocking agents (AVNB) when treating tachydysrhythmias in Wolff-Parkinson-White syndrome (WPW) patients. We investigated medications selected and resulting outcomes for patients with tachydysrhythmias and WPW. In this single-center retrospective cohort study, we searched a hospital-wide database for the following inclusion criteria: WPW, tachycardia, and intravenous antidysrhythmics. The composite outcome of adverse events was acceleration of tachycardia, new hypotension, new malignant dysrhythmia, and cardioversion. The difference in binomial proportions of patients meeting the composite outcome after AVNB or non-AVNB (NAVNB) treatment was calculated after dividing the groups by QRS duration. A random-effects mixed linear analysis was performed to analyze the vital sign response. The initial database search yielded 1158 patient visits, with 60 meeting inclusion criteria. Patients' median age was 52.5 years; 53% were male, 43% presented in wide complex tachycardia (WCT), with 75% in atrial fibrillation (AF) or flutter. AVNBs were administered in 42 (70%) patient visits. For those patients with WCT in AF, the difference in proportions of patients meeting the composite outcome after AVNBs vs. NAVNBs treatment was an increase of 3% (95% confidence interval [CI] -39%-49%), and for those with narrow complex AF it was a decrease of 13% (95% CI -37%-81%). No instances of malignant dysrhythmia occurred. Mixed linear analysis showed no statistically significant effects on heart rate, though suggested a trend toward increasing heart rate after AVNB in wide complex AF. In this sample of WPW-associated tachydysrhythmia patients, many were treated with AVNBs. The composite outcome was similarly met after use of either AVNB or NAVNB, and no malignant dysrhythmias were observed. Copyright © 2014 Elsevier Inc. All rights reserved.

Integrating Aggregate Exposure Pathway (AEP) and Adverse ...

EPA Pesticide Factsheets

High throughput toxicity testing (HTT) holds the promise of providing data for tens of thousands of chemicals that currently have no data due to the cost and time required for animal testing. Interpretation of these results require information linking the perturbations seen in vitro with adverse outcomes in vivo and requires knowledge of how estimated exposure to the chemicals compare to the in vitro concentrations that show an effect. This abstract discusses how Adverse Outcome Pathways (AOPs) can be used to link HTT with adverse outcomes of regulatory significance and how Aggregate Exposure Pathways (AEPs) can connect concentrations of environment stressors at a source with an expected target site concentration designed to provide exposure estimates that are comparable to concentrations identified in HTT. Presentation at the ICCA-LRI and JRC Workshop: Fit-For-Purpose Exposure Assessment For Risk-Based Decision Making

The association of shift-level nurse staffing with adverse patient events.

PubMed

Patrician, Patricia A; Loan, Lori; McCarthy, Mary; Fridman, Moshe; Donaldson, Nancy; Bingham, Mona; Brosch, Laura R

2011-02-01

The objective of this study was to demonstrate the association between nurse staffing and adverse events at the shift level. Despite a growing body of research linking nurse staffing and patient outcomes, the relationship of staffing to patient falls and medication errors remains equivocal, possibly due to dependence on aggregated data. Thirteen military hospitals participated in creating a longitudinal nursing outcomes database to monitor nurse staffing, patient falls and medication errors, and other outcomes. Unit types were analyzed separately to stratify patient and nurse staffing characteristics. Bayesian hierarchical logistic regression modeling was used to examine associations between staffing and adverse events. RN skill mix, total nursing care hours, and experience, measured by a proxy variable, were associated with shift-level adverse events. Consideration must be given to nurse staffing and experience levels on every shift.

Aquatic-Aerobic Exercise as a Means of Stress Reduction during Pregnancy

PubMed Central

Parker, Kara Mallory; Smith, Sheila A.

2003-01-01

The goals of this research were to explore the current literature regarding associations between psychological stress and adverse fetal outcome, associations between aerobic exercise and psychological stress reduction, and associations between aerobic exercise and fetal outcome. The published studies that were located provide evidence of the following: 1) Stress reactivity increases physiologically during pregnancy, 2) pregnant women may experience additional stressors that are usually not experienced in a nonpregnant state, 3) psychological stress in pregnancy is associated with adverse fetal outcome, 4) exercise can be a method of stress reduction, 5) exercise in pregnancy is not associated with adverse fetal outcome, and 6) exercise in pregnancy may provide benefit to the fetus. Data were analyzed from an original study and associations were reported between psychological stress-management activities and participation in aquatic aerobic exercise classes. No reports were available investigating an exercise-induced reduction in psychological stress with fetal outcome. PMID:17273326

Further evidence for periodontal disease as a risk indicator for adverse pregnancy outcomes.

PubMed

Turton, Mervyn; Africa, Charlene W J

2017-06-01

Although there is increasing evidence to suggest an association between periodontal disease and adverse pregnancy outcomes, the issue remains controversial. This study tested the hypothesis that periodontal disease is a risk indicator for preterm delivery of low-birthweight infants. The study sample comprised 443 pregnant women with a mean (± standard deviation) age of 24.13 (±5.30) years. At first visit, maternal oral health status was assessed by the measurement of probing pocket depth and clinical attachment loss, and periodontal status was graded as absent, mild, moderate or severe. An association was sought between pregnancy outcomes and maternal periodontal status. While controlling for other factors, significant associations were found between pregnancy outcomes and maternal periodontal index scores. This study provides further evidence that periodontal disease is a risk indicator for adverse pregnancy outcomes. © 2016 FDI World Dental Federation.

Birth outcome racial disparities: A result of intersecting social and environmental factors.

PubMed

Burris, Heather H; Hacker, Michele R

2017-10-01

Adverse birth outcomes such as preterm birth, low-birth weight, and infant mortality continue to disproportionately affect black and poor infants in the United States. Improvements in healthcare quality and access have not eliminated these disparities. The objective of this review was to consider societal factors, including suboptimal education, income inequality, and residential segregation, that together lead to toxic environmental exposures and psychosocial stress. Many toxic chemicals, as well as psychosocial stress, contribute to the risk of adverse birth outcomes and black women often are more highly exposed than white women. The extent to which environmental exposures combine with stress and culminate in racial disparities in birth outcomes has not been quantified but is likely substantial. Primary prevention of adverse birth outcomes and elimination of disparities will require a societal approach to improve education quality, income equity, and neighborhoods. Copyright © 2017 Elsevier Inc. All rights reserved.

Long-term changes in the personality and psychopathological profile of opiate addicts after nucleus accumbens ablative surgery are associated with treatment outcome.

PubMed

Ge, Shunnan; Chang, Chongwang; Adler, John R; Zhao, Haikang; Chang, Xiaozan; Gao, Li; Wu, Heming; Wang, Jing; Li, Nan; Wang, Xuelian; Gao, Guodong

2013-01-01

To investigate the long-term outcome and changes of the personality and psychopathological profile of opiate addicts after bilateral stereotactic nucleus accumbens (NAc) ablative surgery. 60 patients were followed up for 5 years and abstinent status and adverse events were evaluated. NAc lesion volumes and locations were obtained by postoperative MRI scans. The Chinese version of the Eysenck Personality Questionnaire (EPQ-RSC), the Symptom Checklist-90-Revised (SCL-90-R), the Beck Depression Inventory (BDI), the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the World Health Organization's Quality of Life Questionnaire - Brief Version (WHOQOL-BREF) were administered to the patients before and 5 years after the stereotactic surgery. The total abstinence rate of all patients in their 5th postoperative year was 47.4%. The abstinent patients had a significantly larger lesion volume than the relapsed ones, but a larger lesion volume also increased the risk of adverse events. 5 years after surgery, the abstinent patients showed significant decreases on the Psychoticism (EPQ-P) and Neuroticism (EPQ-N) scores by EPQ-RSC, a significant decline on the Global Severity Index and the subscores in all 10 dimensions by SCL-90-R, significant decreases on the BDI and Y-BOCS scores, and significant improvements on the scores of all domains by WHOQOL-BREF, while for the relapsed patients, only the subscores of obsessive-compulsive by SCL-90-R and the Y-BOCS scores significantly decreased. Postoperative analysis revealed that the abstinent patients had a significantly better score than the relapsed ones by various instruments, and NAc lesion volumes and locations did not correlate with the outcome of any of these instruments. The bilateral ablation of NAc by stereotactic neurosurgery was a feasible method for alleviating psychological dependence on opiate drugs and preventing a relapse. Long-term follow-up suggested that surgery can improve the personality and psychopathological profile of opiate addicts with a trend towards normal levels, provided persistent abstinence can be maintained; relapse, on the other hand, may ruin this effect. Copyright © 2012 S. Karger AG, Basel.

Pregnancy loss history at first parity and selected adverse pregnancy outcomes.

PubMed

Ahrens, Katherine A; Rossen, Lauren M; Branum, Amy M

2016-07-01

To evaluate the association between pregnancy loss history and adverse pregnancy outcomes. Pregnancy history was captured during a computer-assisted personal interview for 21,277 women surveyed in the National Survey of Family Growth (1995-2013). History of pregnancy loss (<20 weeks) at first parity was categorized in three ways: number of losses, maximum gestational age of loss(es), and recency of last pregnancy loss. We estimated risk ratios for a composite measure of selected adverse pregnancy outcomes (preterm, stillbirth, or low birthweight) at first parity and in any future pregnancy, separately, using predicted margins from adjusted logistic regression models. At first parity, compared with having no loss, having 3+ previous pregnancy losses (adjusted risk ratio (aRR) = 1.66 [95% CI = 1.13, 2.43]), a maximum gestational age of loss(es) at ≥10 weeks (aRR = 1.28 [1.04, 1.56]) or having experienced a loss 24+ months ago (aRR = 1.36 [1.10, 1.68]) were associated with increased risks of adverse pregnancy outcomes. For future pregnancies, only having a history of 3+ previous pregnancy losses at first parity was associated with increased risks (aRR = 1.97 [1.08, 3.60]). Number, gestational age, and recency of pregnancy loss at first parity were associated with adverse pregnancy outcomes in U.S. women. Published by Elsevier Inc.

[Maternal hemoglobin in Peru: regional differences and its association with adverse perinatal outcomes].

PubMed

Gonzales, Gustavo F; Tapia, Vilma; Gasco, Manuel; Carrillo, Carlos

2011-01-01

To evaluate hemoglobin (Hb) levels in pregnant women from different geographical regions from Peru; to establish anemia and erythrocytocis rates and to establish the role of Hb on adverse perinatal outcomes using the Perinatal Information System (PIS) database of Peruvian Ministry of Health. Data were obtained from 379,816 births of 43 maternity care units between 2000 and 2010. Anemia and erythrocytocis rates were determined in each geographical region as well as rates of adverse perinatal outcomes. To analyze data the STATA program (versión 10.0,Texas, USA) was used. The results were considered significant at p<0.01. Mild anemia rate was higher in the coast (25.8%) and low forest (26.2%). Moderate/severe anemia rate in low forest was 2.6% and at the coast was 1.0%. In the highland, the highest rate of moderate/severe anemia was in the southern highlands (0.6%). The highest rate of erythrocytocis was found in the central highland (23.7%), 11.9% in the southern highland and 9.5% in the north highland. Severe anemia and erythrocytocis were associated with adverse perinatal outcomes. There are differences by Peruvian geographical region in anemia rates. In the central highlands were found the highest rates of erythrocytocis due to hypoxia effect in the high altitudes; however in the southern highlands, erythrocytocis was lower. Severe anemia and erythrocytosis were associated with increased adverse perinatal outcomes.

Exercise for patients with major depression: a systematic review with meta-analysis and trial sequential analysis.

PubMed

Krogh, Jesper; Hjorthøj, Carsten; Speyer, Helene; Gluud, Christian; Nordentoft, Merete

2017-09-18

To assess the benefits and harms of exercise in patients with depression. Systematic review DATA SOURCES: Bibliographical databases were searched until 20 June 2017. Eligible trials were randomised clinical trials assessing the effect of exercise in participants diagnosed with depression. Primary outcomes were depression severity, lack of remission and serious adverse events (eg, suicide) assessed at the end of the intervention. Secondary outcomes were quality of life and adverse events such as injuries, as well as assessment of depression severity and lack of remission during follow-up after the intervention. Thirty-five trials enrolling 2498 participants were included. The effect of exercise versus control on depression severity was -0.66 standardised mean difference (SMD) (95% CI -0.86 to -0.46; p<0.001; grading of recommendations assessment, development and evaluation (GRADE): very low quality). Restricting this analysis to the four trials that seemed less affected of bias, the effect vanished into -0.11 SMD (-0.41 to 0.18; p=0.45; GRADE: low quality). Exercise decreased the relative risk of no remission to 0.78 (0.68 to 0.90; p<0.001; GRADE: very low quality). Restricting this analysis to the two trials that seemed less affected of bias, the effect vanished into 0.95 (0.74 to 1.23; p=0.78). Trial sequential analysis excluded random error when all trials were analysed, but not if focusing on trials less affected of bias. Subgroup analyses found that trial size and intervention duration were inversely associated with effect size for both depression severity and lack of remission. There was no significant effect of exercise on secondary outcomes. Trials with less risk of bias suggested no antidepressant effects of exercise and there were no significant effects of exercise on quality of life, depression severity or lack of remission during follow-up. Data for serious adverse events and adverse events were scarce not allowing conclusions for these outcomes. The protocol was published in the journal Systematic Reviews : 2015; 4:40. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Randomized, controlled trial of TNF-α antagonist in CTL-mediated severe cutaneous adverse reactions.

PubMed

Wang, Chuang-Wei; Yang, Lan-Yan; Chen, Chun-Bing; Ho, Hsin-Chun; Hung, Shuen-Iu; Yang, Chih-Hsun; Chang, Chee-Jen; Su, Shih-Chi; Hui, Rosaline Chung-Yee; Chin, See-Wen; Huang, Li-Fang; Lin, Yang Yu-Wei; Chang, Wei-Yang; Fan, Wen-Lang; Yang, Chin-Yi; Ho, Ji-Chen; Chang, Ya-Ching; Lu, Chun-Wei; Chung, Wen-Hung

2018-03-01

Cytotoxic T lymphocyte-mediated (CTL-mediated) severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are rare but life-threatening adverse reactions commonly induced by drugs. Although high levels of CTL-associated cytokines, chemokines, or cytotoxic proteins, including TNF-α and granulysin, were observed in SJS-TEN patients in recent studies, the optimal treatment for these diseases remains controversial. We aimed to evaluate the efficacy, safety, and therapeutic mechanism of a TNF-α antagonist in CTL-mediated SCARs. We enrolled 96 patients with SJS-TEN in a randomized trial to compare the effects of the TNF-α antagonist etanercept versus traditional corticosteroids. Etanercept improved clinical outcomes in patients with SJS-TEN. Etanercept decreased the SCORTEN-based predicted mortality rate (predicted and observed rates, 17.7% and 8.3%, respectively). Compared with corticosteroids, etanercept further reduced the skin-healing time in moderate-to-severe SJS-TEN patients (median time for skin healing was 14 and 19 days for etanercept and corticosteroids, respectively; P = 0.010), with a lower incidence of gastrointestinal hemorrhage in all SJS-TEN patients (2.6% for etanercept and 18.2% for corticosteroids; P = 0.03). In the therapeutic mechanism study, etanercept decreased the TNF-α and granulysin secretions in blister fluids and plasma (45.7%-62.5% decrease after treatment; all P < 0.05) and increased the Treg population (2-fold percentage increase after treatment; P = 0.002), which was related to mortality in severe SJS-TEN. The anti-TNF-α biologic agent etanercept serves as an effective alternative for the treatment of CTL-mediated SCARs. ClinicalTrials.gov NCT01276314. Ministry of Science and Technology of Taiwan.

Randomized, controlled trial of TNF-α antagonist in CTL-mediated severe cutaneous adverse reactions

PubMed Central

Wang, Chuang-Wei; Yang, Lan-Yan; Ho, Hsin-Chun; Hung, Shuen-Iu; Yang, Chih-Hsun; Chang, Chee-Jen; Su, Shih-Chi; Hui, Rosaline Chung-Yee; Chin, See-Wen; Huang, Li-Fang; Lin, Yang Yu-Wei; Chang, Wei-Yang; Fan, Wen-Lang; Yang, Chin-Yi; Ho, Ji-Chen; Chung, Wen-Hung

2018-01-01

BACKGROUND. Cytotoxic T lymphocyte–mediated (CTL-mediated) severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are rare but life-threatening adverse reactions commonly induced by drugs. Although high levels of CTL-associated cytokines, chemokines, or cytotoxic proteins, including TNF-α and granulysin, were observed in SJS-TEN patients in recent studies, the optimal treatment for these diseases remains controversial. We aimed to evaluate the efficacy, safety, and therapeutic mechanism of a TNF-α antagonist in CTL-mediated SCARs. METHODS. We enrolled 96 patients with SJS-TEN in a randomized trial to compare the effects of the TNF-α antagonist etanercept versus traditional corticosteroids. RESULTS. Etanercept improved clinical outcomes in patients with SJS-TEN. Etanercept decreased the SCORTEN-based predicted mortality rate (predicted and observed rates, 17.7% and 8.3%, respectively). Compared with corticosteroids, etanercept further reduced the skin-healing time in moderate-to-severe SJS-TEN patients (median time for skin healing was 14 and 19 days for etanercept and corticosteroids, respectively; P = 0.010), with a lower incidence of gastrointestinal hemorrhage in all SJS-TEN patients (2.6% for etanercept and 18.2% for corticosteroids; P = 0.03). In the therapeutic mechanism study, etanercept decreased the TNF-α and granulysin secretions in blister fluids and plasma (45.7%–62.5% decrease after treatment; all P < 0.05) and increased the Treg population (2-fold percentage increase after treatment; P = 0.002), which was related to mortality in severe SJS-TEN. CONCLUSIONS. The anti–TNF-α biologic agent etanercept serves as an effective alternative for the treatment of CTL-mediated SCARs. TRIAL REGISTRATION. ClinicalTrials.gov NCT01276314. FUNDING. Ministry of Science and Technology of Taiwan. PMID:29400697

Real-World Assessment of Renal and Bone Safety among Patients with HIV Infection Exposed to Tenofovir Disoproxil Fumarate-Containing Single-Tablet Regimens.

PubMed

Nkhoma, Ella T; Rosenblatt, Lisa; Myers, Joel; Villasis-Keever, Angelina; Coumbis, John

2016-01-01

Tenofovir disoproxil fumarate (TDF)-containing antiretroviral regimens have been associated with an increased incidence of renal and bone adverse outcomes. Here, we estimated the real-world incidence of renal and bone adverse outcomes among patients with HIV infection receiving different TDF-containing single-tablet regimens (STRs). This cohort study used US health insurance data spanning the years 2008-2014. We identified HIV-infected patients aged ≥18 years (all HIV patients) and those with ≥6 months of continuous enrollment prior to initiating efavirenz/emtricitabine/TDF (EFV/FTC/TDF), rilpivirine/FTC/TDF (RPV/FTC/TDF) or elvitegravir/cobicistat/FTC/TDF (EVG/COBI/FTC/TDF). Renal adverse outcomes were identified using renal International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes. Bone adverse outcomes were identified using ICD-9-CM diagnosis codes for fracture. Incidence rates (IRs) and associated 95% confidence intervals (CIs) were estimated assuming a Poisson distribution, and outcomes between STRs were compared using IR ratios (IRRs) and IR differences (IRDs). We identified 9876 and 10,383 eligible patients for the renal and fracture analyses, respectively. Observed IRs for renal adverse outcomes were 9.7, 10.5, 13.6, and 18.0 per 1000 person-years among those receiving EFV/FTC/TDF, RPV/FTC/TDF, or EVG/COBI/FTC/TDF, or all HIV patients, respectively. Corresponding values for IRs of fracture were 3.4, 3.6, 7.2, and 4.4 per 1000 person-years, respectively. Renal adverse outcomes with EFV/FTC/TDF were significantly less frequent than with EVG/COBI/FTC/TDF (IRD -3.96; 95% CI: -7.31, -1.06). No IRR differences were identified for the renal analysis. Fractures with EFV/FTC/TDF were significantly less frequent than with EVG/COBI/FTC/TDF (IRR 0.47; 95% CI: 0.27, 0.81 and IRD -3.85; 95% CI: -5.02, -2.78). In this large real-world database, observed IRs for renal adverse outcomes with TDF-containing STRs were lower or similar to those for all HIV patients, with the lowest IRs observed among patients receiving EFV/FTC/TDF. Compared with all HIV patients, the observed IR for fracture was higher with EVG/COBI/FTC/TDF, comparable with RPV/FTC/TDF, and lower with EFV/FTC/TDF.

Surgical Adverse Events, Risk Management, and Malpractice Outcome: Morbidity and Mortality Review Is Not Enough

PubMed Central

Morris, John A.; Carrillo, Ysela; Jenkins, Judith M.; Smith, Philip W.; Bledsoe, Sandy; Pichert, James; White, Andrew

2003-01-01

Objective To review all admissions (age > 13) to three surgical patient care centers at a single academic medical center between January 1, 1995, and December 6, 1999, for significant surgical adverse events. Summary Background Data Little data exist on the interrelationships between surgical adverse events, risk management, malpractice claims, and resulting indemnity payments to plaintiffs. The authors hypothesized that examination of this process would identify performance improvement opportunities overlooked by standard medical peer review; the risk of litigation would be constant across the three homogeneous patient care centers; and the risk management process would exceed the performance improvement process. Methods Data collected included patient demographics (age, gender, and employment status), hospital financials (hospital charges, costs, and financial class), and outcome. Outcome categories were medical (disability: <1 month, 1–6 months, permanent/death), legal (no legal action, settlement, summary judgment), financial (indemnity payments, legal fees, write-offs), and cause and effect analysis. Cause and effect analysis attempts to identify system failures contributing to adverse outcomes. This was determined by two independent analysts using the 17 Harvard criteria and subdividing these into subsystem causative factors. Results The study group consisted of 130 patients with surgical adverse events resulting in total liabilities of $8.2 million. The incidence of adverse events per 1,000 admissions across the three patient care centers was similar, but indemnity payments per 1,000 admissions varied (cardiothoracic = $30, women’s health = $90, trauma = $520). Patient demographics were not predictive of high-risk subgroups for adverse events or litigation. In terms of medical outcome, 51 patients had permanent disability or death, accounting for 98% of the indemnity payments. In terms of legal outcome, 103 patients received no indemnity payments, 15 patients received indemnity payments, four suits remain open, and in eight cases charges were written off ($0.121 million). To date, no cases have been adjudicated in court. Cause and effect analysis identified 390 system failures contributing to the adverse events (mean 3.0 failures per adverse event); there were 4.7 failures per adverse event in the 15 indemnity cases. Five categories of causes accounted for 75% of the failures (patient management, n = 104; communication, n = 89; administration, n = 33; documentation, n = 32; behavior, n = 23). The current medical review process would have identified 104 of 390 systems failures (37%). Conclusions This study demonstrates no rational link between the tort system and the reduction of adverse events. Sixty-three percent of contributing causes to adverse events were undetected by current medical review processes. Adverse events occur at the interface between different systems or disciplines and result from multiple failures. Indemnity costs per hospital day vary dramatically by patient care center (range $3.60–97.60 a day). The regionalization of healthcare is in jeopardy from the burden of high indemnity payments. PMID:12796581