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Sample records for 4-item clinical risk

  1. Validation of a 4-item Negative Symptom Assessment (NSA-4): a short, practical clinical tool for the assessment of negative symptoms in schizophrenia.

    PubMed

    Alphs, Larry; Morlock, Robert; Coon, Cheryl; Cazorla, Pilar; Szegedi, Armin; Panagides, John

    2011-06-01

    The 16-item Negative Symptom Assessment (NSA-16) scale is a validated tool for evaluating negative symptoms of schizophrenia. The psychometric properties and predictive power of a four-item version (NSA-4) were compared with the NSA-16. Baseline data from 561 patients with predominant negative symptoms of schizophrenia who participated in two identically designed clinical trials were evaluated. Ordered logistic regression analysis of ratings using NSA-4 and NSA-16 were compared with ratings using several other standard tools to determine predictive validity and construct validity. Internal consistency and test--retest reliability were also analyzed. NSA-16 and NSA-4 scores were both predictive of scores on the NSA global rating (odds ratio = 0.83-0.86) and the Clinical Global Impressions--Severity scale (odds ratio = 0.91-0.93). NSA-16 and NSA-4 showed high correlation with each other (Pearson r = 0.85), similar high correlation with other measures of negative symptoms (demonstrating convergent validity), and lesser correlations with measures of other forms of psychopathology (demonstrating divergent validity). NSA-16 and NSA-4 both showed acceptable internal consistency (Cronbach α, 0.85 and 0.64, respectively) and test--retest reliability (intraclass correlation coefficient, 0.87 and 0.82). This study demonstrates that NSA-4 offers accuracy comparable to the NSA-16 in rating negative symptoms in patients with schizophrenia.

  2. [The relevance of clinical risk management].

    PubMed

    Gulino, Matteo; Vergallo, Gianluca Montanari; Frati, Paola

    2011-01-01

    Medical activity includes a risk of possible injury or complications for the patients, that should drive the Health Care Institutions to introduce and/ or improve clinical Risk management instruments. Although Italy is still lacking a National project of Clinical Risk Management, a number of efforts have been made by different Italian Regions to introduce instruments of risk management. In addition, most of National Health Care Institutions include actually a Department specifically in charge to manage the clinical risk. Despite the practical difficulties, the results obtained until now suggest that the risk management may represent a useful instrument to contribute to the reduction of errors in clinical conduct. Indeed, the introduction of adequate instruments of prevention and management of clinical risk may help to ameliorate the quality of health care Institution services.

  3. Clinical risk and depression (continuing education credit).

    PubMed

    Sharkey, S

    1997-01-22

    This article provides information and guidance to nurses on clinical risks in mental health, particularly that of depression. It relates to UKCC professional development category: Reducing risk and Care enhancement.

  4. Psychometric Evaluation of 5- and 4-Item Versions of the LATCH Breastfeeding Assessment Tool during the Initial Postpartum Period among a Multiethnic Population

    PubMed Central

    Htun, Tha Pyai; Lim, Peng Im; Ho-Lim, Sarah

    2016-01-01

    values. Conclusions We found that the 4-item version demonstrated sound psychometric properties compared to the 5-item version. Health professionals can use the 4-item LATCH as a clinical tool because it is a concise, easy-to-use and valid tool for assessing breastfeeding techniques among a multiethnic population. PMID:27135746

  5. 26 CFR 1.117-4 - Items not considered as scholarships or fellowship grants.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... fellowship grants. 1.117-4 Section 1.117-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... Income § 1.117-4 Items not considered as scholarships or fellowship grants. The following payments or allowances shall not be considered to be amounts received as a scholarship or a fellowship grant for...

  6. 26 CFR 1.117-4 - Items not considered as scholarships or fellowship grants.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... fellowship grants. 1.117-4 Section 1.117-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... Income § 1.117-4 Items not considered as scholarships or fellowship grants. The following payments or allowances shall not be considered to be amounts received as a scholarship or a fellowship grant for...

  7. 26 CFR 1.117-4 - Items not considered as scholarships or fellowship grants.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... fellowship grants. 1.117-4 Section 1.117-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... Income § 1.117-4 Items not considered as scholarships or fellowship grants. The following payments or allowances shall not be considered to be amounts received as a scholarship or a fellowship grant for...

  8. 26 CFR 1.117-4 - Items not considered as scholarships or fellowship grants.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... fellowship grants. 1.117-4 Section 1.117-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... Income § 1.117-4 Items not considered as scholarships or fellowship grants. The following payments or allowances shall not be considered to be amounts received as a scholarship or a fellowship grant for...

  9. 26 CFR 1.117-4 - Items not considered as scholarships or fellowship grants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... fellowship grants. 1.117-4 Section 1.117-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... Income § 1.117-4 Items not considered as scholarships or fellowship grants. The following payments or allowances shall not be considered to be amounts received as a scholarship or a fellowship grant for...

  10. Implementing caries risk assessment and clinical interventions.

    PubMed

    Young, Douglas A; Featherstone, John D B

    2010-07-01

    This article suggests a practical methodology to implement the scientific information presented in the earlier articles into clinical practice. The Caries Balance/Imbalance Model and a practical caries risk assessment procedure for patients aged 6 years through adult illustrate evidence-based treatment options. Neither the forms nor the clinical protocols are meant to imply that there is currently only one correct way that this can be achieved; they are used in this article only as examples.

  11. Clinical Risk Assessment in Intensive Care Unit

    PubMed Central

    Asefzadeh, Saeed; Yarmohammadian, Mohammad H.; Nikpey, Ahmad; Atighechian, Golrokh

    2013-01-01

    Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin's Social Security Hospital (Razi Hospital) through Failure Mode and Effect Analysis (FMEA). Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG) performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN) was in respiratory care “Ventilator's alarm malfunction (no alarm)” with the score 288, and the lowest was in gastrointestinal “not washing the NG-Tube” with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care. PMID:23930171

  12. Risk stratification after myocardial infarction. Clinical overview

    SciTech Connect

    O'Rourke, R.A. )

    1991-09-01

    Many patients with an acute myocardial infarction can be stratified into subgroups that are at high risk for morbidity and mortality on the basis of clinical characteristics that indicate recurrent myocardial ischemia, persistent left ventricular dysfunction, and/or recurrent cardiac arrhythmias. In patients with uncomplicated myocardial infarction the assessment of symptoms, physical findings, and ECG changes during predischarge exercise testing often identifies patients at increased risk for further cardiac events. Because of the suboptimum sensitivity and specificity of the exercise ECG for detecting myocardial ischemia, myocardial perfusion imaging with 201Tl and/or assessment of global and segmental ventricular function by two-dimensional echocardiography or radionuclide cineangiography during or immediately after exercise are often added to the predischarge risk stratification.

  13. Suicide by cop: clinical risks and subtypes.

    PubMed

    Dewey, Lauren; Allwood, Maureen; Fava, Joanna; Arias, Elizabeth; Pinizzotto, Anthony; Schlesinger, Louis

    2013-01-01

    This study examines whether clinical classification schemes from general suicide research are applicable for cases of suicide by cop (SbC) and whether there are indicators as to why the police might be engaged in the suicide. Using archival law enforcement data, 13 clinical risks were examined among 68 cases of SbC using exploratory factor analysis and k-means cluster analysis. Three subtypes of SbC cases emerged: Mental Illness, Criminality, and Not Otherwise Specified. The subtypes varied significantly on their levels of mental illness, substance use, and criminal activity. Findings suggest that reducing fragmentation between law enforcement and mental health service providers might be a crucial goal for suicide intervention and prevention, at least among cases of SbC.

  14. Defining risk from the perspective of nurses in clinical roles.

    PubMed

    Dobos, C

    1992-11-01

    Although the nursing literature suggests that nurses generally avoid risk, their willingness and ability to take risk are fundamental to their professional advancement, job satisfaction and patient advocacy. The definition of risk as it pertains in clinical practice, however, may not be synonymous with risk as defined in other fields. This study defines risk in nursing from the perspective of three registered nurses in clinical roles. Grounded theory methodology indicated that 11 risk categories comprised six core concepts. The latter formed the basis for the following: risk in clinical nursing practice is defined by uncomfortable and typically unavoidable role-related situations characterized by high unpredictability and negative or hostile overtones, dependency on others, exceedingly high performance expectations from self and others, unpleasant emotions, and health threats that extend beyond working hours. Findings of this study refute the notion that nurses avoid risks. Risk, ever present in the nurse's clinical practice and environment, requires strategies to minimize its negative impact. PMID:1430636

  15. Studies on nursing risks and measures of clinical medication.

    PubMed

    Li, Min; Bai, Jie; Huang, Jie

    2015-09-01

    To investigate the cause analysis of clinical medication nursing risks and propose relevant nursing measures, so as to control and reduce the clinical nursing risks and reach the physical and mental safety of patients and nurses. Clinical nursing risk events with 30 cases in TCM Hospital of Zhengzhou City from June 2010 to April 2012 were underwent statistical analyses. The risk of medication error ranked the first in the direct reasons of nursing risks, accounting for a higher ratio. Moreover, the reasons of nursing risks were also involved in nonstandard operation, disease observation and other relative factors. Nurses must fully understand the relative factors of medication nursing risks, regarding the patients as their own family and always permeating the consciousness of nursing risks into the working process. PMID:26525028

  16. Atrial fibrillation: relation between clinical risk factors and transoesophageal echocardiographic risk factors for thromboembolism

    PubMed Central

    Illien, S; Maroto-Järvinen, S; von der Recke, G; Hammerstingl, C; Schmidt, H; Kuntz-Hehner, S; Lüderitz, B; Omran, H

    2003-01-01

    Objective: To correlate clinical risk factors for thromboembolism with transoesophageal echocardiography (TOE) markers of a thrombogenic milieu. Design: Clinical risk factors for thromboembolism and TOE markers of a thrombogenic milieu were assessed in consecutive patients with non-rheumatic atrial fibrillation. The following TOE parameters were assessed: presence of spontaneous echo contrast, thrombi, and left atrial appendage blood flow velocities. A history of hypertension, diabetes mellitus, or thromboembolic events, patient age > 65 years, and chronic heart failure were considered to be clinical risk factors for thromboembolism. Setting: Tertiary cardiac care centre. Patients: 301 consecutive patients with non-rheumatic atrial fibrillation scheduled for TOE. Results: 255 patients presented with clinical risk factors. 158 patients had reduced left atrial blood flow velocities, dense spontaneous echo contrast, or both. Logistic regression analysis showed that a reduced left ventricular ejection fraction and age > 65 years were the only independent predictors of a thrombogenic milieu (both p < 0.0001). The probability of having a thrombogenic milieu increased with the number of clinical risk factors present (p < 0.0001). 17.4% of the patients without clinical risk factors had a thrombogenic milieu whereas 41.2% of the patients presenting one or more clinical risk factors had none. Conclusion: There is a close relation between clinical risk factors and TOE markers of a thrombogenic milieu. In addition, TOE examination allows for the identification of patients with a thrombogenic milieu without clinical risk factors. PMID:12527668

  17. There's risk, and then there's risk: The latest clinical prognostic risk stratification models in myelodysplastic syndromes.

    PubMed

    Zeidan, Amer M; Komrokji, Rami S

    2013-12-01

    Myelodysplastic syndromes (MDS) include a diverse group of clonal hematopoietic disorders characterized by progressive cytopenias and propensity for leukemic progression. The biologic heterogeneity that underlies MDS translates clinically in wide variations of clinical outcomes. Several prognostic schemes were developed to predict the natural course of MDS, counsel patients, and allow evidence-based, risk-adaptive implementation of therapeutic strategies. The prognostic schemes divide patients into subgroups with similar prognosis, but the extent to which the prognostic prediction applies to any individual patient is more variable. None of these instruments was designed to predict the clinical benefit in relation to any specific MDS therapy. The prognostic impact of molecular mutations is being more recognized and attempts at incorporating it into the current prognostic schemes are ongoing.

  18. Clinical Model for Suicide Risk Assessment.

    ERIC Educational Resources Information Center

    Kral, Michael J.; Sakinofsky, Isaac

    1994-01-01

    Presents suicide risk assessment in a two-tiered model comprising background/contextual factors and subjectivity. The subjectivity portion is formulated around Shneidman's concepts of perturbation and lethality. Discusses decision of hospital admission versus ambulatory care. Suggests that theoretically informed approach should serve both…

  19. Clinical Evaluation of a Novel and Mobile Autism Risk Assessment

    ERIC Educational Resources Information Center

    Duda, Marlena; Daniels, Jena; Wall, Dennis P.

    2016-01-01

    The Mobile Autism Risk Assessment (MARA) is a new, electronically administered, 7-question autism spectrum disorder (ASD) screen to triage those at highest risk for ASD. Children 16 months-17 years (N = 222) were screened during their first visit in a developmental-behavioral pediatric clinic. MARA scores were compared to diagnosis from the…

  20. Managing clinical risk: right person, right care, right time.

    PubMed

    Graham, Frank J

    2009-07-01

    Dentists and the dental health care industry have a renewed interest in clinical risk assessment, because they offer the potential to identify a patient's clinical needs for oral health care more specifically, to maximize prevention by early intervention, and to educate patients to become more informed consumers of oral health care and direct resources where they are most needed and can produce the greatest value. To realize this potential, risk assessment must be applied appropriately, and its indirect ramifications for access to care should be considered. Several ideas for the appropriate application of risk assessment are discussed and the ramifications for access to care are explored.

  1. Prediction of clinical risks by analysis of preclinical and clinical adverse events.

    PubMed

    Clark, Matthew

    2015-04-01

    This study examines the ability of nonclinical adverse event observations to predict human clinical adverse events observed in drug development programs. In addition it examines the relationship between nonclinical and clinical adverse event observations to drug withdrawal and proposes a model to predict drug withdrawal based on these observations. These analyses provide risk assessments useful for both planning patient safety programs, as well as a statistical framework for assessing the future success of drug programs based on nonclinical and clinical observations. Bayesian analyses were undertaken to investigate the connection between nonclinical adverse event observations and observations of that same event in clinical trial for a large set of approved drugs. We employed the same statistical methods used to evaluate the efficacy of diagnostic tests to evaluate the ability of nonclinical studies to predict adverse events in clinical studies, and adverse events in both to predict drug withdrawal. We find that some nonclinical observations suggest higher risk for observing the same adverse event in clinical studies, particularly arrhythmias, QT prolongation, and abnormal hepatic function. However the lack of these events in nonclinical studies is found to not be a good predictor of safety in humans. Some nonclinical and clinical observations appear to be associated with high risk of drug withdrawal from market, especially arrhythmia and hepatic necrosis. We use the method to estimate the overall risk of drug withdrawal from market using the product of the risks from each nonclinical and clinical observation to create a risk profile.

  2. Prediction of clinical risks by analysis of preclinical and clinical adverse events.

    PubMed

    Clark, Matthew

    2015-04-01

    This study examines the ability of nonclinical adverse event observations to predict human clinical adverse events observed in drug development programs. In addition it examines the relationship between nonclinical and clinical adverse event observations to drug withdrawal and proposes a model to predict drug withdrawal based on these observations. These analyses provide risk assessments useful for both planning patient safety programs, as well as a statistical framework for assessing the future success of drug programs based on nonclinical and clinical observations. Bayesian analyses were undertaken to investigate the connection between nonclinical adverse event observations and observations of that same event in clinical trial for a large set of approved drugs. We employed the same statistical methods used to evaluate the efficacy of diagnostic tests to evaluate the ability of nonclinical studies to predict adverse events in clinical studies, and adverse events in both to predict drug withdrawal. We find that some nonclinical observations suggest higher risk for observing the same adverse event in clinical studies, particularly arrhythmias, QT prolongation, and abnormal hepatic function. However the lack of these events in nonclinical studies is found to not be a good predictor of safety in humans. Some nonclinical and clinical observations appear to be associated with high risk of drug withdrawal from market, especially arrhythmia and hepatic necrosis. We use the method to estimate the overall risk of drug withdrawal from market using the product of the risks from each nonclinical and clinical observation to create a risk profile. PMID:25746390

  3. Visual Impairment/lntracranial Pressure Risk Clinical Care Data Tools

    NASA Technical Reports Server (NTRS)

    Van Baalen, Mary; Mason, Sara S.; Taiym, Wafa; Wear, Mary L.; Moynihan, Shannan; Alexander, David; Hart, Steve; Tarver, William

    2014-01-01

    Prior to 2010, several ISS crewmembers returned from spaceflight with changes to their vision, ranging from a mild hyperopic shift to frank disc edema. As a result, NASA expanded clinical vision testing to include more comprehensive medical imaging, including Optical Coherence Tomography and 3 Tesla Brain and Orbit MRIs. The Space and Clinical Operations (SCO) Division developed a clinical practice guideline that classified individuals based on their symptoms and diagnoses to facilitate clinical care. For the purposes of clinical surveillance, this classification was applied retrospectively to all crewmembers who had sufficient testing for classification. This classification is also a tool that has been leveraged for researchers to identify potential risk factors. In March 2014, driven in part by a more comprehensive understanding of the imaging data and increased imaging capability on orbit, the SCO Division revised their clinical care guidance to outline in-flight care and increase post-flight follow up. The new clinical guidance does not include a classification scheme

  4. Cardiac PET Perfusion: Prognosis, Risk Stratification, Clinical Management

    PubMed Central

    Dorbala, Sharmila; Di Carli, Marcelo F.

    2014-01-01

    Myocardial perfusion imaging (MPI) with positron emission tomography (PET) has expanded significantly over the past decade. With the wider availability of PET scanners and the routine use of quantitative blood flow imaging, the clinical use of PET MPI is expected to increase further. PET MPI is a powerful tool to identify risk, to quantify risk, and to guide therapy in patients with known or suspected coronary artery disease (CAD). A large body of evidence supports the prognostic value of PET MPI and ejection fraction in intermediate to high risk subjects, in women, in obese individuals and in post coronary artery bypass grafting (CABG) individuals. A normal perfusion study indicates low risk (< 1% annualized rate of cardiac events of cardiac death and non-fatal myocardial infarction), while an abnormal study indicates high risk. With accurate risk stratification, high quality images, and quantitation PET MPI may transform the management of patients with known or suspected CAD. PMID:25234079

  5. [Does clinical risk management require a structured conflict management?].

    PubMed

    Neumann, Stefan

    2015-01-01

    A key element of clinical risk management is the analysis of errors causing near misses or patient damage. After analyzing the causes and circumstances, measures for process improvement have to be taken. Process management, human resource development and other established methods are used. If an interpersonal conflict is a contributory factor to the error, there is usually no structured conflict management available which includes selection criteria for various methods of conflict processing. The European University Viadrina in Frankfurt (Oder) has created a process model for introducing a structured conflict management system which is suitable for hospitals and could fill the gap in the methodological spectrum of clinical risk management. There is initial evidence that a structured conflict management reduces staff fluctuation and hidden conflict costs. This article should be understood as an impulse for discussion on to what extent the range of methods of clinical risk management should be complemented by conflict management.

  6. Suicide during Perinatal Period: Epidemiology, Risk Factors, and Clinical Correlates

    PubMed Central

    Orsolini, Laura; Valchera, Alessandro; Vecchiotti, Roberta; Tomasetti, Carmine; Iasevoli, Felice; Fornaro, Michele; De Berardis, Domenico; Perna, Giampaolo; Pompili, Maurizio; Bellantuono, Cesario

    2016-01-01

    Perinatal period may pose a great challenge for the clinical management and treatment of psychiatric disorders in women. In fact, several mental illnesses can arise during pregnancy and/or following childbirth. Suicide has been considered a relatively rare event during the perinatal period. However, in some mental disorders (i.e., postpartum depression, bipolar disorder, postpartum psychosis, etc.) have been reported a higher risk of suicidal ideation, suicide attempt, or suicide. Therefore, a complete screening of mothers’ mental health should also take into account thoughts of suicide and thoughts about harming infants as well. Clinicians should carefully monitor and early identify related clinical manifestations, potential risk factors, and alarm symptoms related to suicide. The present paper aims at providing a focused review about epidemiological data, risk factors, and an overview about the main clinical correlates associated with the suicidal behavior during the pregnancy and postpartum period. Practical recommendations have been provided as well. PMID:27570512

  7. Suicide during Perinatal Period: Epidemiology, Risk Factors, and Clinical Correlates.

    PubMed

    Orsolini, Laura; Valchera, Alessandro; Vecchiotti, Roberta; Tomasetti, Carmine; Iasevoli, Felice; Fornaro, Michele; De Berardis, Domenico; Perna, Giampaolo; Pompili, Maurizio; Bellantuono, Cesario

    2016-01-01

    Perinatal period may pose a great challenge for the clinical management and treatment of psychiatric disorders in women. In fact, several mental illnesses can arise during pregnancy and/or following childbirth. Suicide has been considered a relatively rare event during the perinatal period. However, in some mental disorders (i.e., postpartum depression, bipolar disorder, postpartum psychosis, etc.) have been reported a higher risk of suicidal ideation, suicide attempt, or suicide. Therefore, a complete screening of mothers' mental health should also take into account thoughts of suicide and thoughts about harming infants as well. Clinicians should carefully monitor and early identify related clinical manifestations, potential risk factors, and alarm symptoms related to suicide. The present paper aims at providing a focused review about epidemiological data, risk factors, and an overview about the main clinical correlates associated with the suicidal behavior during the pregnancy and postpartum period. Practical recommendations have been provided as well. PMID:27570512

  8. Development, Functioning, and Effectiveness of a Preoperative Risk Assessment Clinic

    PubMed Central

    Tariq, Hassan; Ahmed, Rafeeq; Kulkarni, Salil; Hanif, Sana; Toolsie, Omesh; Abbas, Hafsa; Chilimuri, Sridhar

    2016-01-01

    Lee first described the concept of preoperative assessment testing (PAT) clinic in 1949. An efficiently run clinic is associated with increased cost-effectiveness by lowering preoperative admission time and thus reducing the length of stay and the associated costs. The setup of the PAT clinic should be based on the needs, culture, and resources of the institution. Various models for the setup of PAT clinic have been described, including the concept of a perioperative surgical home, which is a patient-centered model designed to improve health and the delivery of health care and to reduce the cost of care. Although there are several constraints in the development of PAT clinics, with increasing awareness about the usefulness of pre-operative risk assessments, growing bodies of literature, and evidence-based guidelines, these clinics are becoming a medical necessity for the improvement of perioperative care. PMID:27812286

  9. A risk assessment of two interorganizational clinical information systems.

    PubMed

    Sicotte, Claude; Paré, Guy; Moreault, Marie-Pierre; Paccioni, André

    2006-01-01

    A risk analysis framework was used to examine the implementation barriers that may hamper the successful implementation of interorganizational clinical information systems (ICIS). In terms of study design, an extensive literature review was first performed in order to elaborate a comprehensive model of project risk factors. To test the applicability of the model, we next conducted a longitudinal multiple-case study of two large-scale ICIS demonstration projects carried out in Quebec, Canada. Variations in the levels of several risk dimensions measured throughout the duration of the projects were analyzed to determine their impact on successful implementation. The analysis shows that the proposed framework, composed of five risk dimensions, was very robust, and suitable for conducting a thorough risk analysis. The results also show that there are links between the quality of the risk management and the level of project outcomes. To be successful, it is important that the implementation efforts be distributed proportionally according to the importance of each of the risk factors. Furthermore, because the risks evolve dynamically, there is a need for high responsiveness to emerging implementation problems. Thus, implementation success lies in the ability of the project management team to be aware of and to manage several risk threats simultaneously and coherently since they evolve dynamically through time and interact with one another. PMID:16799130

  10. A Risk Assessment of Two Interorganizational Clinical Information Systems

    PubMed Central

    Sicotte, Claude; Paré, Guy; Moreault, Marie-Pierre; Paccioni, André

    2006-01-01

    A risk analysis framework was used to examine the implementation barriers that may hamper the successful implementation of interorganizational clinical information systems (ICIS). In terms of study design, an extensive literature review was first performed in order to elaborate a comprehensive model of project risk factors. To test the applicability of the model, we next conducted a longitudinal multiple-case study of two large-scale ICIS demonstration projects carried out in Quebec, Canada. Variations in the levels of several risk dimensions measured throughout the duration of the projects were analyzed to determine their impact on successful implementation. The analysis shows that the proposed framework, composed of five risk dimensions, was very robust, and suitable for conducting a thorough risk analysis. The results also show that there are links between the quality of the risk management and the level of project outcomes. To be successful, it is important that the implementation efforts be distributed proportionally according to the importance of each of the risk factors. Furthermore, because the risks evolve dynamically, there is a need for high responsiveness to emerging implementation problems. Thus, implementation success lies in the ability of the project management team to be aware of and to manage several risk threats simultaneously and coherently since they evolve dynamically through time and interact with one another. PMID:16799130

  11. On the privacy risks of sharing clinical proteomics data.

    PubMed

    Li, Sujun; Bandeira, Nuno; Wang, Xiaofeng; Tang, Haixu

    2016-01-01

    Although the privacy issues in human genomic studies are well known, the privacy risks in clinical proteomic data have not been thoroughly studied. As a proof of concept, we reported a comprehensive analysis of the privacy risks in clinical proteomic data. It showed that a small number of peptides carrying the minor alleles (referred to as the minor allelic peptides) at non-synonymous single nucleotide polymorphism (nsSNP) sites can be identified in typical clinical proteomic datasets acquired from the blood/serum samples of individual patient, from which the patient can be identified with high confidence. Our results suggested the presence of significant privacy risks in raw clinical proteomic data. However, these risks can be mitigated by a straightforward pre-processing step of the raw data that removing a very small fraction (0.1%, 7.14 out of 7,504 spectra on average) of MS/MS spectra identified as the minor allelic peptides, which has little or no impact on the subsequent analysis (and re-use) of these datasets. PMID:27595046

  12. On the privacy risks of sharing clinical proteomics data

    PubMed Central

    Li, Sujun; Bandeira, Nuno; Wang, Xiaofeng; Tang, Haixu

    2016-01-01

    Although the privacy issues in human genomic studies are well known, the privacy risks in clinical proteomic data have not been thoroughly studied. As a proof of concept, we reported a comprehensive analysis of the privacy risks in clinical proteomic data. It showed that a small number of peptides carrying the minor alleles (referred to as the minor allelic peptides) at non-synonymous single nucleotide polymorphism (nsSNP) sites can be identified in typical clinical proteomic datasets acquired from the blood/serum samples of individual patient, from which the patient can be identified with high confidence. Our results suggested the presence of significant privacy risks in raw clinical proteomic data. However, these risks can be mitigated by a straightforward pre-processing step of the raw data that removing a very small fraction (0.1%, 7.14 out of 7,504 spectra on average) of MS/MS spectra identified as the minor allelic peptides, which has little or no impact on the subsequent analysis (and re-use) of these datasets. PMID:27595046

  13. On the privacy risks of sharing clinical proteomics data

    PubMed Central

    Li, Sujun; Bandeira, Nuno; Wang, Xiaofeng; Tang, Haixu

    2016-01-01

    Although the privacy issues in human genomic studies are well known, the privacy risks in clinical proteomic data have not been thoroughly studied. As a proof of concept, we reported a comprehensive analysis of the privacy risks in clinical proteomic data. It showed that a small number of peptides carrying the minor alleles (referred to as the minor allelic peptides) at non-synonymous single nucleotide polymorphism (nsSNP) sites can be identified in typical clinical proteomic datasets acquired from the blood/serum samples of individual patient, from which the patient can be identified with high confidence. Our results suggested the presence of significant privacy risks in raw clinical proteomic data. However, these risks can be mitigated by a straightforward pre-processing step of the raw data that removing a very small fraction (0.1%, 7.14 out of 7,504 spectra on average) of MS/MS spectra identified as the minor allelic peptides, which has little or no impact on the subsequent analysis (and re-use) of these datasets.

  14. Solemnity: A Clinical Risk Index for Iron Deficient Infants.

    ERIC Educational Resources Information Center

    Honig, Alice Sterling; Oski, Frank A.

    1984-01-01

    Studies four groups of infants with iron deficiency but without anemia in an attempt to discover behavioral signs that can be used to index high-risk probability for iron deficiency. Solemnity in well-attached infants is suggested as a clinical sign to indicate the need for biochemical screening for iron deficiency. (AS)

  15. Quantifying the Risk of Blood Exposure in Optometric Clinical Education.

    ERIC Educational Resources Information Center

    Hoppe, Elizabeth

    1997-01-01

    A study attempted to quantify risk of blood exposure in optometric clinical education by surveying optometric interns in their fourth year at the Southern California College of Optometry concerning their history of exposure or use of a needle. Results indicate blood exposure or needle use ranged from 0.95 to 18.71 per 10,000 patient encounters.…

  16. Ethics: the risk management tool in clinical research.

    PubMed

    Wadlund, Jill; Platt, Leslie A

    2002-01-01

    Scientific discovery and knowledge expansion in the post genome era holds great promise for new medical technologies and cellular-based therapies with multiple applications that will save and enhance lives. While human beings long have hoped to unlock the mysteries of the molecular basis of life; our society is now on the verge of doing so. But new scientific and technological breakthroughs often come with some risks attached. Research--especially clinical trials and research involving human participants--must be conducted in accordance with the highest ethical and scientific principles. Yet, as the number and complexity of clinical trials increase, so do pressures for new revenue sources and shorter product development cycles, which could have an adverse impact on patient safety. This article explores the use of risk management tools in clinical research.

  17. Multirater reliability of the historical, clinical, and risk management-20.

    PubMed

    Penney, Stephanie R; McMaster, Robert; Wilkie, Treena

    2014-02-01

    The assessment and management of risk for future violence is a core requirement of mental health professionals in many settings. Despite an increasing need for violence risk assessments across diverse contexts, little is known regarding the ecological validity of many widely used risk assessment schemes or the level of reliability with which actual practicing clinicians score these instruments. The current study investigated the interrater reliability of the Historical, Clinical, and Risk Management-20 (HCR-20), a widely used structured professional tool to assess violence risk, among 21 practicing clinicians in a forensic psychiatric program in Ontario, Canada. Results suggest that clinicians with varying professional training backgrounds and experience were able to rate the HCR-20 with good to excellent levels of reliability across three patients who varied in risk level. Consistent with studies investigating rater reliability for research purposes, we found that the risk management scale of the HCR-20 was the most challenging for clinicians to rate reliably. Importantly, results from generalizability theory analyses revealed that less than 3% of the variance in HCR-20 total scores and summary risk ratings is attributable to rater effects, whereas the majority of variance is attributable to differences among patients. PMID:24343237

  18. Neonatal Candidiasis: Epidemiology, Risk Factors, and Clinical Judgment

    PubMed Central

    Benjamin, Daniel K.; Stoll, Barbara J.; Gantz, Marie G.; Walsh, Michele C.; Sanchez, Pablo J.; Das, Abhik; Shankaran, Seetha; Higgins, Rosemary D.; Auten, Kathy J.; Miller, Nancy A.; Walsh, Thomas J.; Laptook, Abbot R.; Carlo, Waldemar A.; Kennedy, Kathleen A.; Finer, Neil N.; Duara, Shahnaz; Schibler, Kurt; Chapman, Rachel L.; Van Meurs, Krisa P.; Frantz, Ivan D.; Phelps, Dale L.; Poindexter, Brenda B.; Bell, Edward F.; O’Shea, T. Michael; Watterberg, Kristi L.; Goldberg, Ronald N.

    2011-01-01

    OBJECTIVE Invasive candidiasis is a leading cause of infection-related morbidity and mortality in extremely low-birth-weight (<1000 g) infants. We quantify risk factors predicting infection in high-risk premature infants and compare clinical judgment with a prediction model of invasive candidiasis. METHODS The study involved a prospective observational cohort of infants <1000 g birth weight at 19 centers of the NICHD Neonatal Research Network. At each sepsis evaluation, clinical information was recorded, cultures obtained, and clinicians prospectively recorded their estimate of the probability of invasive candidiasis. Two models were generated with invasive candidiasis as their outcome: 1) potentially modifiable risk factors and 2) a clinical model at time of blood culture to predict candidiasis. RESULTS Invasive candidiasis occurred in 137/1515 (9.0%) infants and was documented by positive culture from ≥ 1 of these sources: blood (n=96), cerebrospinal fluid (n=9), urine obtained by catheterization (n=52), or other sterile body fluid (n=10). Mortality was not different from infants who had positive blood culture compared to those with isolated positive urine culture. Incidence varied from 2–28% at the 13 centers enrolling ≥ 50 infants. Potentially modifiable risk factors (model 1) included central catheter, broad-spectrum antibiotics (e.g., third-generation cephalosporins), intravenous lipid emulsion, endotracheal tube, and antenatal antibiotics. The clinical prediction model (model 2) had an area under the receiver operating characteristic curve of 0.79, and was superior to clinician judgment (0.70) in predicting subsequent invasive candidiasis. Performance of clinical judgment did not vary significantly with level of training. CONCLUSION Prior antibiotics, presence of a central catheter, endotracheal tube, and center were strongly associated with invasive candidiasis. Modeling was more accurate in predicting invasive candidiasis than clinical judgment. PMID

  19. Risk stratification in non-ST elevation acute coronary syndromes: Risk scores, biomarkers and clinical judgment

    PubMed Central

    Corcoran, David; Grant, Patrick; Berry, Colin

    2015-01-01

    Undifferentiated chest pain is one of the most common reasons for emergency department attendance and admission to hospitals. Non-ST elevation acute coronary syndrome (NSTE-ACS) is an important cause of chest pain, and accurate diagnosis and risk stratification in the emergency department must be a clinical priority. In the future, the incidence of NSTE-ACS will rise further as higher sensitivity troponin assays are implemented in clinical practice. In this article, we review contemporary approaches for the diagnosis and risk stratification of NSTE-ACS during emergency care. We consider the limitations of current practices and potential improvements. Clinical guidelines recommend an early invasive strategy in higher risk NSTE-ACS. The Global Registry of Acute Coronary Events (GRACE) risk score is a validated risk stratification tool which has incremental prognostic value for risk stratification compared with clinical assessment or troponin testing alone. In emergency medicine, there has been a limited adoption of the GRACE score in some countries (e.g. United Kingdom), in part related to a delay in obtaining timely blood biochemistry results. Age makes an exponential contribution to the GRACE score, and on an individual patient basis, the risk of younger patients with a flow-limiting culprit coronary artery lesion may be underestimated. The future incorporation of novel cardiac biomarkers into this diagnostic pathway may allow for earlier treatment stratification. The cost-effectiveness of the new diagnostic pathways based on high-sensitivity troponin and copeptin must also be established. Finally, diagnostic tests and risk scores may optimize patient care but they cannot replace patient-focused good clinical judgment. PMID:26753174

  20. Clinical Features and Developing Risks of Saphenous Vein Thrombophlebitis

    PubMed Central

    2016-01-01

    We evaluated the clinical features and the risks of 14 patients with 14 limbs affected by saphenous vein thrombophlebitis from April 2007 to May 2013 and compared the results with patients undergoing operative repair of varicose veins (127 patients, 193 limbs) during the study period. The frequency of patients with a body mass index over 25 (78.6% vs. 35.3%, p = 0.0018), varicose change in the saphenous vein (78.6% vs. 6.2%, p <0.0001), and concurrent thrombosis in another vein (50.0% vs. 7.1%, p <0.0001) were all significantly higher than those of the patients under operative repair for varicose veins. These patients with clinical features above may be at an elevated risk of thrombophlebitis of the saphenous trunk. (This article is a translation of J Jpn Coll Angiol 2014; 54: 151–157). PMID:27375800

  1. Attributional Style among Youth at Clinical Risk for Psychosis

    PubMed Central

    DeVylder, Jordan E.; Ben-David, Shelly; Kimhy, David; Corcoran, Cheryl M.

    2012-01-01

    Aim A biased attributional style, in which negative events are attributed to external and personal causes, is associated with paranoid delusions in schizophrenia. It is not known whether this biased attributional style also characterizes individuals at clinical risk for psychosis, or if it is associated with their emergent paranoia. Methods 33 clinical high-risk patients and 15 age- and gender-similar controls were assessed with the Internal, Personal, and Situational Attributions Questionnaire for externalizing and personalizing attributional biases and for potential correlates with suspiciousness and other symptoms. Results Both patients and controls had a similar external-personalizing attributional style, which was unrelated to symptoms, including suspiciousness. Conclusions Consistent with other studies, a biased attributional style was not associated with subthreshold paranoia. Therefore, a biased attributional style is likely not a trait that contributes to emergent paranoid delusions, but instead a state-dependent correlate of paranoid delusions. PMID:22390315

  2. Vascular Risk Factors and Clinical Progression in Spinocerebellar Ataxias

    PubMed Central

    Lo, Raymond Y.; Figueroa, Karla P.; Pulst, Stefan M.; Lin, Chi-Ying; Perlman, Susan; Wilmot, George; Gomez, Christopher M.; Schmahmann, Jeremy; Paulson, Henry; Shakkottai, Vikram G.; Ying, Sarah H.; Zesiewicz, Theresa; Bushara, Khalaf; Geschwind, Michael; Xia, Guangbin; Subramony, S. H.; Ashizawa, Tetsuo; Kuo, Sheng-Han

    2015-01-01

    Background The contributions of vascular risk factors to spinocerebellar ataxia (SCA) are not known. Methods We studied 319 participants with SCA 1, 2, 3, and 6 and repeatedly measured clinical severity using the Scale for Assessment and Rating of Ataxia (SARA) for 2 years. Vascular risk factors were summarized by CHA2DS2-VASc scores as the vascular risk factor index. We employed regression models to study the effects of vascular risk factors on ataxia onset and progression after adjusting for age, sex, and pathological CAG repeats. Our secondary analyses took hyperlipidemia into account. Results Nearly 60% of SCA participants were at low vascular risks with CHA2DS2-VASc = 0, and 31% scored 2 or greater. Higher CHA2DS2-VASc scores were not associated with either earlier onset or faster progression of ataxia. These findings were not altered after accounting for hyperlipidemia. Discussion Vascular risks are not common in SCAs and are not associated with earlier onset or faster ataxia progression. PMID:25713748

  3. Smell identification in individuals at clinical high risk for schizophrenia.

    PubMed

    Gill, Kelly Elizabeth; Evans, Elizabeth; Kayser, Jürgen; Ben-David, Shelly; Messinger, Julie; Bruder, Gerard; Malaspina, Dolores; Corcoran, Cheryl Mary

    2014-12-15

    Smell identification deficits exist in schizophrenia, and may be associated with its negative symptoms. Less is known about smell identification and its clinical correlates in individuals at clinical high risk (CHR) for schizophrenia and related psychotic disorders. We examined smell identification, symptoms and IQ in 71 clinical high-risk (CHR) subjects and 36 healthy controls. Smell identification was assessed using both the 40-item University of Pennsylvania Smell Identification Test (UPSIT; Doty, R.L., Shaman, P., Kimmelman, C.P., Dann, M.S., 1984. University of Pennsylvania Smell Identification Test: a rapid quantitative olfactory function test for the clinic. Laryngoscope 94, 176-178) and its extracted 12-item Brief Smell Identification Test (Goudsmit, N., Coleman, E., Seckinger, R.A., Wolitzky, R., Stanford, A.D., Corcoran, C., Goetz, R.R., Malaspina, D., 2003. A brief smell identification test discriminates between deficit and non-deficit schizophrenia. Psychiatry Research 120, 155-164). Smell identification did not significantly differ between CHR subjects and controls. Among CHR subjects, smell identification did not predict schizophrenia (N=19; 27%) within 2 years, nor was it associated with negative or positive symptoms. This is the third prospective cohort study to examine smell identification in CHR subjects, and overall, findings are inconclusive, similar to what is found for other disorders in adolescents, such as autism spectrum, attention deficit and anxiety disorders. Smell identification deficit may not have clear utility as a marker of emergent schizophrenia and related psychotic disorders.

  4. Clinical Manifestation and Risk Factors of Tuberculosis Infection in Malaysia: Case Study of a Community Clinic

    PubMed Central

    Shanmuganathan, Rohan; Shanmuganathan, Indra Devi

    2015-01-01

    Introduction: The main aim of this study was to describe the clinical manifestation of tuberculosis infection cases in Malaysia and to determine the individual risk factors for their occurrence. Methodology: The study adopted a quantitative research approach with use of descriptive statistical approach. The study setting was a community clinic which treats walk in patients who are mainly living and working in the surrounding areas. The study was conducted for a period of one year. All tuberculosis patients who sought treatment in the clinic during the time were included in this study. The total number of cases was 40. Data was collected from the medical records of the tuberculosis patients. The risk factors selected for investigation were demographic characteristics of age and sex, personal habits such as smoking, drug use and alcohol and presence of diseases such as human immunodeficiency virus positive (HIV+), diabetes mellitus, cancer, cyanotic heart disease, renal failure and steroid use. Results: Patients in the age group ranging from 41 to 50 years had the highest incidence of the infection. Smoking appears to be the most important risk factor for contracting followed by drug abuse, HIV+ infection and diabetes mellitus. Conclusions: People with diseases such as diabetes mellitus and HIV that are high risk factors for TB should be screened for TB so that early detection and intervention is possible. Educational programs should be carried out to create awareness among the at risk groups. PMID:25946947

  5. The 4-Item Negative Symptom Assessment (NSA-4) Instrument: A Simple Tool for Evaluating Negative Symptoms in Schizophrenia Following Brief Training.

    PubMed

    Alphs, Larry; Morlock, Robert; Coon, Cheryl; van Willigenburg, Arjen; Panagides, John

    2010-07-01

    Objective. To assess the ability of mental health professionals to use the 4-item Negative Symptom Assessment instrument, derived from the Negative Symptom Assessment-16, to rapidly determine the severity of negative symptoms of schizophrenia.Design. Open participation.Setting. Medical education conferences.Participants. Attendees at two international psychiatry conferences.Measurements. Participants read a brief set of the 4-item Negative Symptom Assessment instructions and viewed a videotape of a patient with schizophrenia. Using the 1 to 6 4-item Negative Symptom Assessment severity rating scale, they rated four negative symptom items and the overall global negative symptoms. These ratings were compared with a consensus rating determination using frequency distributions and Chi-square tests for the proportion of participant ratings that were within one point of the expert rating.Results. More than 400 medical professionals (293 physicians, 50% with a European practice, and 55% who reported past utilization of schizophrenia ratings scales) participated. Between 82.1 and 91.1 percent of the 4-items and the global rating determinations by the participants were within one rating point of the consensus expert ratings. The differences between the percentage of participant rating scores that were within one point versus the percentage that were greater than one point different from those by the consensus experts was significant (p<0.0001). Participants rating of negative symptoms using the 4-item Negative Symptom Assessment did not generally differ among the geographic regions of practice, the professional credentialing, or their familiarity with the use of schizophrenia symptom rating instruments.Conclusion. These findings suggest that clinicians from a variety of geographic practices can, after brief training, use the 4-item Negative Symptom Assessment effectively to rapidly assess negative symptoms in patients with schizophrenia.

  6. Clinical dysphagia risk predictors after prolonged orotracheal intubation

    PubMed Central

    de Medeiros, Gisele Chagas; Sassi, Fernanda Chiarion; Mangilli, Laura Davison; Zilberstein, Bruno; de Andrade, Claudia Regina Furquim

    2014-01-01

    OBJECTIVES: To elucidate independent risk factors for dysphagia after prolonged orotracheal intubation. METHODS: The participants were 148 consecutive patients who underwent clinical bedside swallowing assessments from September 2009 to September 2011. All patients had received prolonged orotracheal intubations and were admitted to one of several intensive care units of a large Brazilian school hospital. The correlations between the conducted water swallow test results and dysphagia risk levels were analyzed for statistical significance. RESULTS: Of the 148 patients included in the study, 91 were male and 57 were female (mean age, 53.64 years). The univariate analysis results indicated that specific variables, including extraoral loss, multiple swallows, cervical auscultation, vocal quality, cough, choking, and other signs, were possible significant high-risk indicators of dysphagia onset. The multivariate analysis results indicated that cervical auscultation and coughing were independent predictive variables for high dysphagia risk. CONCLUSIONS: Patients displaying extraoral loss, multiple swallows, cervical auscultation, vocal quality, cough, choking and other signs should benefit from early swallowing evaluations. Additionally, early post-extubation dysfunction recognition is paramount in reducing the morbidity rate in this high-risk population. PMID:24473554

  7. Estimating the re-identification risk of clinical data sets

    PubMed Central

    2012-01-01

    Background De-identification is a common way to protect patient privacy when disclosing clinical data for secondary purposes, such as research. One type of attack that de-identification protects against is linking the disclosed patient data with public and semi-public registries. Uniqueness is a commonly used measure of re-identification risk under this attack. If uniqueness can be measured accurately then the risk from this kind of attack can be managed. In practice, it is often not possible to measure uniqueness directly, therefore it must be estimated. Methods We evaluated the accuracy of uniqueness estimators on clinically relevant data sets. Four candidate estimators were identified because they were evaluated in the past and found to have good accuracy or because they were new and not evaluated comparatively before: the Zayatz estimator, slide negative binomial estimator, Pitman’s estimator, and mu-argus. A Monte Carlo simulation was performed to evaluate the uniqueness estimators on six clinically relevant data sets. We varied the sampling fraction and the uniqueness in the population (the value being estimated). The median relative error and inter-quartile range of the uniqueness estimates was measured across 1000 runs. Results There was no single estimator that performed well across all of the conditions. We developed a decision rule which selected between the Pitman, slide negative binomial and Zayatz estimators depending on the sampling fraction and the difference between estimates. This decision rule had the best consistent median relative error across multiple conditions and data sets. Conclusion This study identified an accurate decision rule that can be used by health privacy researchers and disclosure control professionals to estimate uniqueness in clinical data sets. The decision rule provides a reliable way to measure re-identification risk. PMID:22776564

  8. Breast cancer risk prediction using a clinical risk model and polygenic risk score.

    PubMed

    Shieh, Yiwey; Hu, Donglei; Ma, Lin; Huntsman, Scott; Gard, Charlotte C; Leung, Jessica W T; Tice, Jeffrey A; Vachon, Celine M; Cummings, Steven R; Kerlikowske, Karla; Ziv, Elad

    2016-10-01

    Breast cancer risk assessment can inform the use of screening and prevention modalities. We investigated the performance of the Breast Cancer Surveillance Consortium (BCSC) risk model in combination with a polygenic risk score (PRS) comprised of 83 single nucleotide polymorphisms identified from genome-wide association studies. We conducted a nested case-control study of 486 cases and 495 matched controls within a screening cohort. The PRS was calculated using a Bayesian approach. The contributions of the PRS and variables in the BCSC model to breast cancer risk were tested using conditional logistic regression. Discriminatory accuracy of the models was compared using the area under the receiver operating characteristic curve (AUROC). Increasing quartiles of the PRS were positively associated with breast cancer risk, with OR 2.54 (95 % CI 1.69-3.82) for breast cancer in the highest versus lowest quartile. In a multivariable model, the PRS, family history, and breast density remained strong risk factors. The AUROC of the PRS was 0.60 (95 % CI 0.57-0.64), and an Asian-specific PRS had AUROC 0.64 (95 % CI 0.53-0.74). A combined model including the BCSC risk factors and PRS had better discrimination than the BCSC model (AUROC 0.65 versus 0.62, p = 0.01). The BCSC-PRS model classified 18 % of cases as high-risk (5-year risk ≥3 %), compared with 7 % using the BCSC model. The PRS improved discrimination of the BCSC risk model and classified more cases as high-risk. Further consideration of the PRS's role in decision-making around screening and prevention strategies is merited. PMID:27565998

  9. Emerging Comorbidities in Adult Asthma: Risks, Clinical Associations, and Mechanisms

    PubMed Central

    Kankaanranta, Hannu; Kauppi, Paula; Tuomisto, Leena E.; Ilmarinen, Pinja

    2016-01-01

    Asthma is a heterogeneous disease with many phenotypes, and age at disease onset is an important factor in separating the phenotypes. Most studies with asthma have been performed in patients being otherwise healthy. However, in real life, comorbid diseases are very common in adult patients. We review here the emerging comorbid conditions to asthma such as obesity, metabolic syndrome, diabetes mellitus type 2 (DM2), and cardiac and psychiatric diseases. Their role as risk factors for incident asthma and whether they affect clinical asthma are evaluated. Obesity, independently or as a part of metabolic syndrome, DM2, and depression are risk factors for incident asthma. In contrast, the effects of comorbidities on clinical asthma are less well-known and mostly studies are lacking. Cross-sectional studies in obese asthmatics suggest that they may have less well controlled asthma and worse lung function. However, no long-term clinical follow-up studies with these comorbidities and asthma were identified. These emerging comorbidities often occur in the same multimorbid adult patient and may have in common metabolic pathways and inflammatory or other alterations such as early life exposures, systemic inflammation, inflammasome, adipokines, hyperglycemia, hyperinsulinemia, lung mechanics, mitochondrial dysfunction, disturbed nitric oxide metabolism, and leukotrienes. PMID:27212806

  10. Risk, diagnostic error, and the clinical science of consciousness

    PubMed Central

    Peterson, Andrew; Cruse, Damian; Naci, Lorina; Weijer, Charles; Owen, Adrian M.

    2015-01-01

    In recent years, a number of new neuroimaging techniques have detected covert awareness in some patients previously thought to be in a vegetative state/unresponsive wakefulness syndrome. This raises worries for patients, families, and physicians, as it indicates that the existing diagnostic error rate in this patient group is higher than assumed. Recent research on a subset of these techniques, called active paradigms, suggests that false positive and false negative findings may result from applying different statistical methods to patient data. Due to the nature of this research, these errors may be unavoidable, and may draw into question the use of active paradigms in the clinical setting. We argue that false positive and false negative findings carry particular moral risks, which may bear on investigators' decisions to use certain methods when independent means for estimating their clinical utility are absent. We review and critically analyze this methodological problem as it relates to both fMRI and EEG active paradigms. We conclude by drawing attention to three common clinical scenarios where the risk of diagnostic error may be most pronounced in this patient group. PMID:25844313

  11. Clinical risk factors for the development of consecutive exotropia: a comparative clinical study

    PubMed Central

    Taylan Sekeroglu, Hande; Erkan Turan, Kadriye; Karakaya, Jale; Sener, Emin Cumhur; Sanac, Ali Sefik

    2016-01-01

    AIM To compare a group of patients with consecutive exotropia with patients who had ≤10 prism diopters (PD) esotropia or no deviation postoperatively in terms of probable clinical risk factors for the development of consecutive exotropia. METHODS The study recruited fourteen patients who developed consecutive exodeviation during follow-up period after the correction of esotropia who were categorized as group 1 and thirty-one patients who had still ≤10 PD esotropia or no deviation at the final visit that were considered as group 2. Clinical risk factors leading the development of consecutive deviation were analyzed as the main outcome measures. RESULTS The mean age of patients was 4.57±3.11y in group 1 and 5.10±3.52y in group 2 (P=0.634). There was no significant difference of preoperative near and distant deviations among two groups (P=0.835, 0.928 respectively). The mean amount of medial rectus recession and lateral rectus resection was similar in both groups (P=0.412, 0.648 respectively). Convergence insufficiency and neurological diseases were more frequent in group 1 (P=0.007, 0.045). Accompanying neurological disease was found to be as a significant factor increasing the risk of the development of consecutive exotropia significantly [odds ratios (OR): 5.75 (1.04-31.93)]. CONCLUSION Accompanying neurological disease appears to be a significant clinical risk factor for the development of consecutive exodeviation during postoperative follow-up after the correction of esotropia. However, larger studies are needed in order to interpret the results to the clinical practice and to ascertain other concurrent risk factors. PMID:27366693

  12. Mining disease risk patterns from nationwide clinical databases for the assessment of early rheumatoid arthritis risk.

    PubMed

    Chin, Chu Yu; Weng, Meng Yu; Lin, Tzu Chieh; Cheng, Shyr Yuan; Yang, Yea Huei Kao; Tseng, Vincent S

    2015-01-01

    Rheumatoid arthritis (RA) is a chronic autoimmune rheumatic disease that can cause painful swelling in the joint lining, morning stiffness, and joint deformation/destruction. These symptoms decrease both quality of life and life expectancy. However, if RA can be diagnosed in the early stages, it can be controlled with pharmacotherapy. Although many studies have examined the possibility of early assessment and diagnosis, few have considered the relationship between significant risk factors and the early assessment of RA. In this paper, we present a novel framework for early RA assessment that utilizes data preprocessing, risk pattern mining, validation, and analysis. Under our proposed framework, two risk patterns can be discovered. Type I refers to well-known risk patterns that have been identified by existing studies, whereas Type II denotes unknown relationship risk patterns that have rarely or never been reported in the literature. These Type II patterns are very valuable in supporting novel hypotheses in clinical trials of RA, and constitute the main contribution of this work. To ensure the robustness of our experimental evaluation, we use a nationwide clinical database containing information on 1,314 RA-diagnosed patients over a 12-year follow-up period (1997-2008) and 965,279 non-RA patients. Our proposed framework is employed on this large-scale population-based dataset, and is shown to effectively discover rich RA risk patterns. These patterns may assist physicians in patient assessment, and enhance opportunities for early detection of RA. The proposed framework is broadly applicable to the mining of risk patterns for major disease assessments. This enables the identification of early risk patterns that are significantly associated with a target disease.

  13. Mining Disease Risk Patterns from Nationwide Clinical Databases for the Assessment of Early Rheumatoid Arthritis Risk

    PubMed Central

    Chin, Chu Yu; Weng, Meng Yu; Lin, Tzu Chieh; Cheng, Shyr Yuan; Yang, Yea Huei Kao; Tseng, Vincent S.

    2015-01-01

    Rheumatoid arthritis (RA) is a chronic autoimmune rheumatic disease that can cause painful swelling in the joint lining, morning stiffness, and joint deformation/destruction. These symptoms decrease both quality of life and life expectancy. However, if RA can be diagnosed in the early stages, it can be controlled with pharmacotherapy. Although many studies have examined the possibility of early assessment and diagnosis, few have considered the relationship between significant risk factors and the early assessment of RA. In this paper, we present a novel framework for early RA assessment that utilizes data preprocessing, risk pattern mining, validation, and analysis. Under our proposed framework, two risk patterns can be discovered. Type I refers to well-known risk patterns that have been identified by existing studies, whereas Type II denotes unknown relationship risk patterns that have rarely or never been reported in the literature. These Type II patterns are very valuable in supporting novel hypotheses in clinical trials of RA, and constitute the main contribution of this work. To ensure the robustness of our experimental evaluation, we use a nationwide clinical database containing information on 1,314 RA-diagnosed patients over a 12-year follow-up period (1997–2008) and 965,279 non-RA patients. Our proposed framework is employed on this large-scale population-based dataset, and is shown to effectively discover rich RA risk patterns. These patterns may assist physicians in patient assessment, and enhance opportunities for early detection of RA. The proposed framework is broadly applicable to the mining of risk patterns for major disease assessments. This enables the identification of early risk patterns that are significantly associated with a target disease. PMID:25875441

  14. Perineal dermatitis risk factors: clinical validation of a conceptual framework.

    PubMed

    Brown, D S

    1995-01-01

    As part of a larger study previously published in December of 1994, the question was asked whether commonly used pressure ulcer assessment tools (the Braden and Medley) were applicable to a broader definition of "skin risk assessment" and altered skin integrity related to perineal dermatitis (PD), and, if so, which risk factors were actually related to PD. The three site randomized clinical trial compared the use of diapers and underpads for 166 adult patients hospitalized on medical and surgical floors who were incontinent of urine and/or feces. Variables related to skin breakdown were the number of incontinence episodes, fecal incontinence, poor skin condition, pain, poor oxygenation, fevers, and mobility problems. Results also suggest that older patients may not have the sensory perception to experience discomfort in the same intensity as younger patients. Based on the findings of this study, pressure ulcer risk assessment tools are not good risk assessment tools for PD. The previously published conceptual framework for PD was modified and validated to form a basis for preventive measures. PMID:8679050

  15. Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).

    PubMed

    Tricarico, Pierfrancesco; Tardivo, Stefano; Sotgiu, Giovanni; Moretti, Francesca; Poletti, Piera; Fiore, Alberto; Monturano, Massimo; Mura, Ida; Privitera, Gaetano; Brusaferro, Silvio

    2016-08-01

    Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries. PMID:27477931

  16. Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).

    PubMed

    Tricarico, Pierfrancesco; Tardivo, Stefano; Sotgiu, Giovanni; Moretti, Francesca; Poletti, Piera; Fiore, Alberto; Monturano, Massimo; Mura, Ida; Privitera, Gaetano; Brusaferro, Silvio

    2016-08-01

    Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries.

  17. Clinical imaging guidelines part 2: Risks, benefits, barriers, and solutions.

    PubMed

    Malone, James; del Rosario-Perez, Maria; Van Bladel, Lodewijk; Jung, Seung Eun; Holmberg, Ola; Bettmann, Michael A

    2015-02-01

    A recent international meeting was convened by two United Nations bodies to focus on international collaboration on clinical appropriateness/referral guidelines for use in medical imaging. This paper, the second of 4 from this technical meeting, addresses barriers to the successful development/deployment of clinical imaging guidelines and means of overcoming them. It reflects the discussions of the attendees, and the issues identified are treated under 7 headings: ■ Practical Strategy for Development and Deployment of Guidelines; ■ Governance Arrangements and Concerns with Deployment of Guidelines; ■ Finance, Sustainability, Reimbursement, and Related Issues; ■ Identifying Benefits and Radiation Risks from Radiological Examinations; ■ Information Given to Patients and the Public, and Consent Issues; ■ Special Concerns Related to Pregnancy; and ■ The Research Agenda. Examples of topics identified include the observation that guideline development is a global task and there is no case for continuing it as the project of the few professional organizations that have been brave enough to make the long-term commitment required. Advocacy for guidelines should include the expectations that they will facilitate: (1) better health care delivery; (2) lower cost of that delivery; with (3) reduced radiation dose and associated health risks. Radiation protection issues should not be isolated; rather, they should be integrated with the overall health care picture. The type of dose/radiation risk information to be provided with guidelines should include the uncertainty involved and advice on application of the precautionary principle with patients. This principle may be taken as an extension of the well-established medical principle of "first do no harm." PMID:25652302

  18. Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials

    PubMed Central

    Hanna, Eve; Rémuzat, Cecile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Objective Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation. Methods We searched for ATMPs trials conducted between 1999 to June 2015 using three databases, which are Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the EU Drug Regulating Authorities Clinical Trials (EudraCT). We selected the ATMPs trials after elimination of the duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organizations. We classified ATMPs by type and trial status, that is, ongoing, completed, terminated, discontinued, and prematurely ended. Then, we calculated the rate of discontinuation. Results Between 1999 and June 2015, 143 withdrawn, terminated, or prematurely ended ATMPs clinical trials were identified. Between 1999 and June 2013, 474 ongoing and completed clinical trials were identified. Therefore, the rate of discontinuation of ATMPs trials is 23.18%, similar to that for non-ATMPs drugs in development. The probability of discontinuation is, respectively, 27.35, 16.28, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (43%), followed by cardiology (19.2%). It is almost the same for commercial and non-commercial sponsors; therefore, the discontinuation reason may not be financially driven. Conclusion No failure risk rate per development phase is available for ATMPs. The discontinuation rate may

  19. Assessing hospitals' clinical risk management: Development of a monitoring instrument

    PubMed Central

    2010-01-01

    Background Clinical risk management (CRM) plays a crucial role in enabling hospitals to identify, contain, and manage risks related to patient safety. So far, no instruments are available to measure and monitor the level of implementation of CRM. Therefore, our objective was to develop an instrument for assessing CRM in hospitals. Methods The instrument was developed based on a literature review, which identified key elements of CRM. These elements were then discussed with a panel of patient safety experts. A theoretical model was used to describe the level to which CRM elements have been implemented within the organization. Interviews with CRM practitioners and a pilot evaluation were conducted to revise the instrument. The first nationwide application of the instrument (138 participating Swiss hospitals) was complemented by in-depth interviews with 25 CRM practitioners in selected hospitals, for validation purposes. Results The monitoring instrument consists of 28 main questions organized in three sections: 1) Implementation and organizational integration of CRM, 2) Strategic objectives and operational implementation of CRM at hospital level, and 3) Overview of CRM in different services. The instrument is available in four languages (English, German, French, and Italian). It allows hospitals to gather comprehensive and systematic data on their CRM practice and to identify areas for further improvement. Conclusions We have developed an instrument for assessing development stages of CRM in hospitals that should be feasible for a continuous monitoring of developments in this important area of patient safety. PMID:21144039

  20. Methyldibromo glutaronitrile: clinical experience and exposure-based risk assessment.

    PubMed

    Zachariae, Claus; Rastogi, Suresh; Devantier, Charlotte; Menné, Torkil; Johansen, Jeanne Duus

    2003-03-01

    In the year 2000, the level of methyldibromo glutaronitrile (MDGN) allergy in dermatology clinics in Europe exceeded the level of allergies to all other preservatives, with a prevalence of 3.5%. In the present study, cases of primary sensitization and elicitation to MDGN due to cosmetic products were collected over an 8-month period at the Department of Dermatology, Gentofte University Hospital. The aim was to identify the products related to hand eczema, assess exposure to MDGN in these products and relate the findings to results from a newly developed updated risk assessment model for contact allergy. Out of 24 patients with a positive patch test to MDGN, 17 patients with hand eczema were identified. In 11 of these patients, cosmetic products used in relation to the onset of the disease were shown to contain MDGN (65%). In 8 of these 11 cases, primary sensitization was probable, 5 due to hand/body lotions and 3 due to lotions and/or liquid hand soap. Chemical analysis of 12 products showed that lotions contained 149-390 ppm of MDGN, liquid hand soap 144-399 ppm, a rinsing cream 293 ppm and shampoos 78-79 ppm. The shampoo exposure was not of certain relevance to the eczema. Applying the newly developed updated risk assessment model showed that the concentrations of MDGN in lotions of 149-390 ppm exceeded the calculated maximum acceptable exposure level for MDGN, which would be expected to lead to sensitization in consumers using such products, as seen in the current study. The present cases and updated exposure-based risk assessment process add to the evidence and need for re-defining safe-use concentrations of MDGN in cosmetic products.

  1. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    PubMed Central

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-01-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  2. Clinical validity and utility of genetic risk scores in prostate cancer

    PubMed Central

    Helfand, Brian T; Kearns, James; Conran, Carly; Xu, Jianfeng

    2016-01-01

    Current issues related to prostate cancer (PCa) clinical care (e.g., over-screening, over-diagnosis, and over-treatment of nonaggressive PCa) call for risk assessment tools that can be combined with family history (FH) to stratify disease risk among men in the general population. Since 2007, genome-wide association studies (GWASs) have identified more than 100 SNPs associated with PCa susceptibility. In this review, we discuss (1) the validity of these PCa risk-associated SNPs, individually and collectively; (2) the various methods used for measuring the cumulative effect of multiple SNPs, including genetic risk score (GRS); (3) the adequate number of SNPs needed for risk assessment; (4) reclassification of risk based on evolving numbers of SNPs used to calculate genetic risk, (5) risk assessment for men from various racial groups, and (6) the clinical utility of genetic risk assessment. In conclusion, data available to date support the clinical validity of PCa risk-associated SNPs and GRS in risk assessment among men with or without FH. PCa risk-associated SNPs are not intended for diagnostic use; rather, they should be used the same way as FH. Combining GRS and FH can significantly improve the performance of risk assessment. Improved risk assessment may have important clinical utility in targeted PCa testing. However, clinical trials are urgently needed to evaluate this clinical utility as well as the acceptance of GRS by patients and physicians. PMID:27297129

  3. Pulmonary embolism, part I: Epidemiology, risk factors and risk stratification, pathophysiology, clinical presentation, diagnosis and nonthrombotic pulmonary embolism

    PubMed Central

    Bĕlohlávek, Jan; Dytrych, Vladimír; Linhart, Aleš

    2013-01-01

    Pulmonary embolism is an important clinical entity with considerable mortality despite advances in diagnosis and treatment. In the present article, the authors offer a comprehensive review focused mainly on epidemiology, risk factors, risk stratification, pathophysiological considerations and clinical presentation. Diagnosis based on assessment of clinical likelihood, electrocardiography, chest x-ray, D-dimer levels, markers of myocardial injury and overload, and blood gases is discussed in detail. Special attention is devoted to the clinical use of computed tomography, pulmonary angiography and echocardiography in the setting of pulmonary embolism. PMID:23940438

  4. Clinical characteristics and risk factors of ocular candidiasis.

    PubMed

    Nagao, Miki; Saito, Takashi; Doi, Shoichi; Hotta, Gou; Yamamoto, Masaki; Matsumura, Yasufumi; Matsushima, Aki; Ito, Yutaka; Takakura, Shunji; Ichiyama, Satoshi

    2012-06-01

    Ocular candidiasis is a major complication of Candida bloodstream infection (BSI). This study was performed to reveal the clinical characteristics of ocular candidiasis. Of the 220 patients with Candida BSI, 204 cases received ophthalmology consultations between January 2005 and December 2011 at 2 teaching hospitals. Fifty-four (26.5%) cases had findings consistent with the diagnosis of ocular candidiasis. Of these 54 cases, 43 (79.6%) were diagnosed within 7 days after a positive blood culture. Among ocular candidiasis cases, more cases were due to Candida albicans (P =0.034 odds ratio [OR]; 3.68 95% confidence interval [CI] 1.11-12.2) and had higher β-d-glucan values (P = 0.001 OR; 9.99 95% CI 2.60-21.3). We need to consider fundoscopic examination to be performed within the first 7 days of therapy, especially for those patients who have C. albicans BSIs and higher β-d-glucan values. Additionally, follow-up fundoscopic examination should be considered before stopping therapy for high-risk patients.

  5. Plasmodium vivax: clinical spectrum, risk factors and pathogenesis.

    PubMed

    Anstey, Nicholas M; Douglas, Nicholas M; Poespoprodjo, Jeanne R; Price, Ric N

    2012-01-01

    Vivax malaria was historically described as 'benign tertian malaria' because individual clinical episodes were less likely to cause severe illness than Plasmodium falciparum. Despite this, Plasmodium vivax was, and remains, responsible for major morbidity and significant mortality in vivax-endemic areas. Single infections causing febrile illness in otherwise healthy individuals rarely progress to severe disease. Nevertheless, in the presence of co-morbidities, P. vivax can cause severe illness and fatal outcomes. Recurrent or chronic infections in endemic areas can cause severe anaemia and malnutrition, particularly in early childhood. Other severe manifestations include acute lung injury, acute kidney injury and uncommonly, coma. Multiorgan failure and shock are described but further studies are needed to investigate the role of bacterial and other co-infections in these syndromes. In pregnancy, P. vivax infection can cause maternal anaemia, miscarriage, low birth weight and congenital malaria. Compared to P. falciparum, P. vivax has a greater capacity to elicit an inflammatory response, resulting in a lower pyrogenic threshold. Conversely, cytoadherence of P. vivax to endothelial cells is less frequent and parasite sequestration is not thought to be a significant cause of severe illness in vivax malaria. With a predilection for young red cells, P. vivax does not result in the high parasite biomass associated with severe disease in P. falciparum, but a four to fivefold greater removal of uninfected red cells from the circulation relative to P. falciparum is associated with a similar risk of severe anaemia. Mechanisms underlying the pathogenesis of severe vivax syndromes remain incompletely understood.

  6. Potential Risks and Mitigation Strategies Before the Conduct of a Clinical Trial: An Industry Perspective.

    PubMed

    Bhagat, Seema; Kapatkar, Vaibhavi K; Mourya, Meenakshi; Roy, Sucheta; Jha, Shailendra; Reddy, Rajasekhar; Kadhe, Ganesh; Mane, Amey; Sawant, Sandesh

    2016-01-01

    Conduct of clinical trials has undergone substantial changes over the last two decades. Newer markets, evolving guidelines and documentation and high cost involved in conducting the trials have led pharmaceutical companies to prepare a risk mitigation plan. Extensive monitoring of potential risks is an essential element of clinical trials which helps to ensure quality and integrity of a clinical investigation. Every clinical trial has pre (before the trial), conduct and post phase. This article which has been developed as a result of extensive research at ground level by a reputed pharmaceutical company to identify the potential stages of risks that could affect the overall quality and safety of a trial and its outcome during the pre-phase of trial (the stage of the trial where the study design is being planned before initiation of the clinical trial). It includes risks associated with basic study concept, protocol design, Confidential Disclosure Agreement (CDA) and Clinical Trial Authorization (CTA) application signing, vendors of central drug laboratory, site and investigator selection, Clinical Research Coordinator (CRC) meet, Informed Consent Form (ICF), Case Report Form (CRF)/ Status Report Form (SRF) preparation, Ethics Committee (EC) submission, etc. have been highlighted. The risk based mitigation strategy (to develop an effective risk monitoring plan before staring a clinical trial) has also been suggested by authors. A well-tailored and integrated plan, recognition of potential risks and their mitigation strategy can result in the pre exclusion or end to end solution of all the risks associated with pre- phase of clinical trials.

  7. Facial emotion perception differs in young persons at genetic and clinical high-risk for psychosis.

    PubMed

    Kohler, Christian G; Richard, Jan A; Brensinger, Colleen M; Borgmann-Winter, Karin E; Conroy, Catherine G; Moberg, Paul J; Gur, Ruben C; Gur, Raquel E; Calkins, Monica E

    2014-05-15

    A large body of literature has documented facial emotion perception impairments in schizophrenia. More recently, emotion perception has been investigated in persons at genetic and clinical high-risk for psychosis. This study compared emotion perception abilities in groups of young persons with schizophrenia, clinical high-risk, genetic risk and healthy controls. Groups, ages 13-25, included 24 persons at clinical high-risk, 52 first-degree relatives at genetic risk, 91 persons with schizophrenia and 90 low risk persons who completed computerized testing of emotion recognition and differentiation. Groups differed by overall emotion recognition abilities and recognition of happy, sad, anger and fear expressions. Pairwise comparisons revealed comparable impairments in recognition of happy, angry, and fearful expressions for persons at clinical high-risk and schizophrenia, while genetic risk participants were less impaired, showing reduced recognition of fearful expressions. Groups also differed for differentiation of happy and sad expressions, but differences were mainly between schizophrenia and control groups. Emotion perception impairments are observable in young persons at-risk for psychosis. Preliminary results with clinical high-risk participants, when considered along findings in genetic risk relatives, suggest social cognition abilities to reflect pathophysiological processes involved in risk of schizophrenia. PMID:24582775

  8. 21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Clinical investigations not involving greater than minimal risk. 50.51 Section 50.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Investigations § 50.51 Clinical investigations not involving greater than minimal risk. Any...

  9. Particulate Air Pollution and Clinical Cardiovascular Disease Risk Factors

    PubMed Central

    Shanley, Ryan P; Hayes, Richard B; Cromar, Kevin R; Ito, Kazuhiko; Gordon, Terry; Ahn, Jiyoung

    2016-01-01

    BACKGROUND Long-term exposure to ambient particulate matter (PM) air pollution is associated with increased cardiovascular disease (CVD); however, the impact of PM on clinical risk factors for CVD in healthy subjects is unclear. We examined the relationship of PM with levels of circulating lipids and blood pressure in the Third National Health and Nutrition Examination Survey (NHANES III), a large nationally-representative US survey. METHODS This study was based on 11,623 adult participants of NHANES III (1988–1994; median age 41.0). Serum lipids and blood pressure were measured during the NHANES III examination. Average exposure for 1988–1994 to particulate matter <10µm in aerodynamic diameter (PM10) at the residences of participants was estimated based on measurements from U.S. Environmental Protection Agency monitors. Multivariate linear regression was used to estimate the associations of PM10 with lipids and blood pressure. RESULTS An interquartile range width (IQRw) increase in PM10 exposure (11.1 µg/m3) in the study population was associated with 2.42 percent greater serum triglycerides (95% confidence interval [CI]: 1.09–3.76); multivariate adjusted means of triglycerides according to increasing quartiles of PM10 were 137.6, 142.5, 142.6, and 148.9 mg/dL, respectively. An IQRw increase in PM10 was associated with 1.43 percent greater total cholesterol (95% CI: 1.21–1.66). These relationships with triglycerides and total cholesterol did not differ by age or region. Associations of PM10 with blood pressure were modest. CONCLUSIONS Findings from this large diverse study indicate that greater long-term PM10 exposure is associated with elevated serum triglycerides and total cholesterol, potentially mediating air pollution-related effects on CVD. PMID:26605815

  10. Long‐Term Post‐CABG Survival: Performance of Clinical Risk Models Versus Actuarial Predictions

    PubMed Central

    Carr, Brendan M.; Romeiser, Jamie; Ruan, Joyce; Gupta, Sandeep; Seifert, Frank C.; Zhu, Wei

    2015-01-01

    Abstract Background/aim Clinical risk models are commonly used to predict short‐term coronary artery bypass grafting (CABG) mortality but are less commonly used to predict long‐term mortality. The added value of long‐term mortality clinical risk models over traditional actuarial models has not been evaluated. To address this, the predictive performance of a long‐term clinical risk model was compared with that of an actuarial model to identify the clinical variable(s) most responsible for any differences observed. Methods Long‐term mortality for 1028 CABG patients was estimated using the Hannan New York State clinical risk model and an actuarial model (based on age, gender, and race/ethnicity). Vital status was assessed using the Social Security Death Index. Observed/expected (O/E) ratios were calculated, and the models' predictive performances were compared using a nested c‐index approach. Linear regression analyses identified the subgroup of risk factors driving the differences observed. Results Mortality rates were 3%, 9%, and 17% at one‐, three‐, and five years, respectively (median follow‐up: five years). The clinical risk model provided more accurate predictions. Greater divergence between model estimates occurred with increasing long‐term mortality risk, with baseline renal dysfunction identified as a particularly important driver of these differences. Conclusions Long‐term mortality clinical risk models provide enhanced predictive power compared to actuarial models. Using the Hannan risk model, a patient's long‐term mortality risk can be accurately assessed and subgroups of higher‐risk patients can be identified for enhanced follow‐up care. More research appears warranted to refine long‐term CABG clinical risk models. doi: 10.1111/jocs.12665 (J Card Surg 2016;31:23–30) PMID:26543019

  11. Implications of the concept of minimal risk in research on informed choice in clinical practice.

    PubMed

    Wada, Kyoko; Nisker, Jeff

    2015-10-01

    The concept of a minimal risk threshold in research, beneath which exception to informed consent and ethics review processes may occur, has been codified for over 30 years in many national research regulations and by the Council for International Organizations of Medical Sciences. Although minimal risk in research constitutes one of the criteria for allowing waiver of informed consent or modification to the consent process and a large body of literature exists, discussion of a minimal risk threshold in clinical practice has not occurred. One reason for lack of discussion may be that implicit consent is accepted for a wide range of routine clinical practices. Extending the role of minimal risk in research to clinical practice might assist clinicians in identifying circumstances for which implicit consent is indeed sufficient and circumstances in which it is not. Further, concepts from minimal risk in research might assist clinicians regarding when information provision in health promotion is required. We begin by reviewing concepts in both minimal risk in research and informed choice in clinical practice. We then explore how a clinical minimal risk concept may clarify recommendations for information provision in clinical practice and support the patient's informed choice regarding therapeutic and diagnostic procedures and also health promotion. Given that clinical practice involves a broad scope of health information, professional practice guidelines on information provision based on the application of the minimal risk threshold in research could be developed to guide clinicians in what information must be provided to their patients.

  12. Anti-tumor necrosis factor patent expiration and the risks of biocopies in clinical practice.

    PubMed

    Scheinberg, Morton; Castañeda-Hernández, Gilberto

    2014-01-01

    Biosimilars that were not compared in clinical trials with the compound innovator are not true biosimilars (biocopies) and are associated with risks that the clinical rheumatologist should be aware of before generalized use. This article comments on various aspects surrounding the use of such biocopies in clinical rheumatology. PMID:25677586

  13. Modifiable Risk Factors for Attempted Suicide in Australian Clinical and Community Samples

    ERIC Educational Resources Information Center

    Carter, Gregory L.; Page, Andrew; Clover, Kerrie; Taylor, Richard

    2007-01-01

    Modifiable risk factors for suicide attempt require identification in clinical and community samples. The aim of this study was to determine if similar social and psychiatric factors are associated with suicide attempts in community and clinical settings and whether the magnitude of effect is greater in clinical populations. Two case-control…

  14. Assessing Violence Risk: A Review and Clinical Recommendations

    ERIC Educational Resources Information Center

    Haggard-Grann, Ulrika

    2007-01-01

    Guidance to identify and manage clients with a perceived high risk for future violence is of great importance for mental health professionals. In the past decade, several structured instruments have been developed to assess risk of future violence. Awareness of the limits and abilities of such instruments is required. This article reviews the most…

  15. Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit

    PubMed Central

    2014-01-01

    Background Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners. Methods This paper describes the monitoring methods and procedures that are utilised by a non-commercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks. Results Monitoring activities and approaches should be selected to be proportionate to the risks identified within a trial. A risk-proportionate approach to monitoring is described giving details of methods that may be considered by clinical trial practitioners during the development of a trial monitoring plan. An example risk assessment and corresponding monitoring plan for a low risk (type A in the Medicines and Healthcare Products Regulatory Agency (MHRA) classification system) pediatric trial is provided for illustration. Conclusion We present ideas for developing a monitoring plan for a clinical trial of an investigational medicinal product based on our experience. Alternative approaches may be relevant or preferable in other settings based on inherent risk. PMID:24739398

  16. Summarizing polygenic risks for complex diseases in a clinical whole genome report

    PubMed Central

    Kong, Sek Won; Lee, In-Hee; Leschiner, Ignaty; Krier, Joel; Kraft, Peter; Rehm, Heidi L.; Green, Robert C.; Kohane, Isaac S.; MacRae, Calum A.

    2015-01-01

    Purpose Disease-causing mutations and pharmacogenomic variants are of primary interest for clinical whole-genome sequencing. However, estimating genetic liability for common complex diseases using established risk alleles might one day prove clinically useful. Methods We compared polygenic scoring methods using a case-control data set with independently discovered risk alleles in the MedSeq Project. For eight traits of clinical relevance in both the primary-care and cardiomyopathy study cohorts, we estimated multiplicative polygenic risk scores using 161 published risk alleles and then normalized using the population median estimated from the 1000 Genomes Project. Results Our polygenic score approach identified the overrepresentation of independently discovered risk alleles in cases as compared with controls using a large-scale genome-wide association study data set. In addition to normalized multiplicative polygenic risk scores and rank in a population, the disease prevalence and proportion of heritability explained by known common risk variants provide important context in the interpretation of modern multilocus disease risk models. Conclusion Our approach in the MedSeq Project demonstrates how complex trait risk variants from an individual genome can be summarized and reported for the general clinician and also highlights the need for definitive clinical studies to obtain reference data for such estimates and to establish clinical utility. PMID:25341114

  17. Insights and clinical questions about the active surveillance of low-risk papillary thyroid microcarcinomas [Review].

    PubMed

    Ito, Yasuhiro; Oda, Hitomi; Miyauchi, Akira

    2016-04-25

    Over 20 years ago, two Japanese institutions initiated an active surveillance policy for papillary microcarcinomas (PMCs) without high-risk features (such as clinical lymph node and distant metastases) and suspected trachea or recurrent laryngeal nerve invasion. Since the most recent American Thyroid Association (ATA) guidelines adopt active surveillance as a therapy option for low-risk PMCs, the number of institutions worldwide carrying out this policy can be expected to increase. However, before adopting an active surveillance strategy, some important clinical questions must be considered. In this review, conceivable clinical questions with our answers based on the present accumulation of low-risk PMC surveillance data are presented. PMID:26632168

  18. Radiation risk from mammography: is it clinically significant

    SciTech Connect

    Feig, S.A.

    1984-09-01

    The observation of excess breast cancers among women exposed to high doses of radiation has led to speculation that a similar risk of smaller magnitude could result from the low doses of x-rays used in mammography. However, such risk is extremely small and seems negligible when compared with the potential benefit for mammographic screening performed according to the American Cancer Society and American College of Radiology Guidelines.

  19. Radiation risk from mammography: is it clinically significant

    SciTech Connect

    Feig, S.A.

    1984-09-01

    The observation of excess breast cancers among women exposed to high doses of radiation has led to speculation that a similar risk of smaller magnitude could result from the low doses of x-rays used in mammography. However, such risk is extremely small and seems negligible when compared with the potential benefit for mammographic screening performed according to the American Cancer Society and American College of Radiology guidelines.

  20. The major risk factors for delirium in a clinical setting

    PubMed Central

    Kim, Harin; Chung, Seockhoon; Joo, Yeon Ho; Lee, Jung Sun

    2016-01-01

    Objective We aimed to determine the major risk factors for the development of delirium in patients at a single general hospital by comparison with a control group. Subjects and methods We reviewed the medical records of 260 delirium patients and 77 control patients. We investigated age, sex, and risk factors for delirium in the total delirium group (n=260), the delirium medical subgroup (n=142), and the delirium surgical subgroup (n=118). Logistic regression analysis adjusting for age and sex was performed to identify the odds ratio. Results The mean age and the percentage of males were significantly higher in the delirium group compared with the control group (68.9 vs 54.3 years and 70% vs 41.6%, respectively). Risk factors for the delirium group were lower plasma albumin, hypertension, mechanical ventilation, and antipsychotic drug use. Plasma sodium level and hypertension were important risk factors for the delirium medical subgroup. Stroke history, hypertension, ICU care, and medication were important risk factors for the delirium surgical subgroup. Conclusion Lower plasma albumin, hypertension, mechanical ventilation, and antipsychotic drug use are important risk factors for delirium. PMID:27499625

  1. Perceived Risk of Breast Cancer among Latinas Attending Community Clinics: Risk Comprehension and Relationship with Mammography Adherence

    PubMed Central

    Graves, Kristi D.; Huerta, Elmer; Cullen, Jennifer; Kaufman, Elizabeth; Sheppard, Vanessa; Luta, George; Isaacs, Claudine; Schwartz, Marc D.; Mandelblatt, Jeanne

    2015-01-01

    Objective To describe breast cancer risk perceptions, determine risk comprehension, and evaluate mammography adherence among Latinas. Methods Latina women age ≥ 35, primarily from Central and South America, were recruited from community-based clinics to complete in-person interviews (n=450). Risk comprehension was calculated as the difference between numeric perceived risk and Gail risk score. Based on recommended guidelines from the year data were collected (2002), mammography adherence was defined as having a mammogram every one to two years for women ≥ 40 years of age. Results Breast cancer risk comprehension was low, as 81% of women overestimated their risk and only 6.9% of women were high risk based on Gail risk scores. Greater cancer worry and younger age were significantly associated with greater perceived risk and risk overestimation. Of women age eligible for mammography (n = 328), 29.0% were non-adherent to screening guidelines. Adherence was associated with older age, (OR = 2.99, 95% CI = 1.76 – 5.09), having insurance (OR = 1.81, 95% CI = 1.03 – 3.17), greater acculturation (OR = 1.18, 95% CI = 1.02 – 1.36), and higher breast cancer knowledge (OR = 2.03, 95% CI = 1.21 – 3.40). Conclusions While most Latinas over-estimated their breast cancer risk, older age, having insurance, being more acculturated, and having greater knowledge were associated with greater screening adherence in this Latino population. Perceived risk, risk comprehension, and cancer worry were not associated with adherence. In Latinas, screening interventions should emphasize knowledge and target education efforts at younger, uninsured, and less acculturated mammography-eligible women. PMID:18704716

  2. An examination of the Clinical Impairment Assessment among women at high risk for eating disorder onset

    PubMed Central

    Vannucci, Anna; Kass, Andrea E.; Sinton, Meghan M.; Aspen, Vandana; Weisman, Hannah; Bailey, Jakki O.; Wilfley, Denise E.; Taylor, C. Barr

    2013-01-01

    Identifying measures that reliably and validly assess clinical impairment has important implications for eating disorder (ED) diagnosis and treatment. The current study examined the psychometric properties of the Clinical Impairment Assessment (CIA) in women at high risk for ED onset. Participants were 543 women (20.6 ± 2.0 years) who were classified into one of three ED categories: clinical ED, high risk for ED onset, and low risk control. Among high risk women, the CIA demonstrated high internal consistency (α = 0.93) and good convergent validity with disordered eating attitudes (rs = 0.27–0.68, ps < 0.001). Examination of the CIA’s discriminant validity revealed that CIA global scores were highest among women with a clinical ED (17.7 ± 10.7) followed by high risk women (10.6 ± 8.5) and low risk controls (3.0 ± 3.3), respectively (p < 0.001). High risk women reporting behavioral indices of ED psychopathology (objective and/or subjective binge episodes, purging behaviors, driven exercise, and ED treatment history) had higher CIA global scores than those without such indices (ps < 0.05), suggesting good criterion validity. These data establish the first norms for the CIA in a United States sample. The CIA is psychometrically sound among high risk women, and heightened levels of impairment among these individuals as compared to low risk women verify the relevance of early intervention efforts. PMID:22516320

  3. Clinical Risk Characteristics of Upper Gastrointestinal Hemorrhage Severity: A Multivariable Risk Analysis

    PubMed Central

    Chaikitamnuaychok, Rangson; Patumanond, Jayanton

    2012-01-01

    Background Upper gastrointestinal hemorrhage (UGIH) is one of the common clinical manifestations encountered in most emergency departments. Patient characteristics indicating UGIH severity in developing countries may be different from those in developed countries. The present study was designed to explore clinical prognostic indicators for UGIH severity. Methods A retrospective cohort study was conducted in a university affiliated tertiary hospital in Kamphaeng Phet, Thailand. Medical folders of patients with UGIH were reviewed. Patients were grouped into 3 severity levels, based on criteria proposed by The American College of Surgeon. Pre-defined prognostic indicators were compared. The prognostic indicators for UGIH severity were analyzed by a multivariable continuation ratio ordinal logistic regression and presented with odds ratios. Results From 1,043 eligible medical folders, 984 (94.3%) complete folders were used in analysis. There were 241, 631 and 112 patients in the mild, moderate and severe UGIH groups. Six independent indicators of severe UGIH were, hemoglobin < 100 g/dL (OR = 13.82, 95% CI = 9.40 to 20.33, P < 0.001), systolic blood pressure < 100 mmHg (OR = 11.01, 95% CI = 7.41 to 16.36, P < 0.001), presence of hepatic failure (OR = 5.50, 95% CI = 1.14 to26.64, P = 0.037), presence of cirrhosis (OR = 2.03, 95% CI = 1.32 to 3.11, P = 0.001), blood urea nitrogen ≥ 35 mmol/L (OR = 1.73, 95% CI = 1.25 to 2.40, P = 0.001), and pulse rate ≥ 100 per minute (OR = 1.72, 95% CI = 1.21 to 2.45, P = 0.003). Conclusions Pulse rate ≥ 100 per minute, systolic blood pressure < 100 mmHg, hemoglobin < 10 g/dL, blood urea nitrogen ≥ 35 mmol/L, presence of cirrhosis and presence of hepatic failure are prognostic indicators for an increase in UGIH severity levels. They are potentially useful in UGIH risk stratification.

  4. Risk of arrhythmia induced by psychotropic medications: a proposal for clinical management.

    PubMed

    Fanoe, Søren; Kristensen, Diana; Fink-Jensen, Anders; Jensen, Henrik Kjærulf; Toft, Egon; Nielsen, Jimmi; Videbech, Poul; Pehrson, Steen; Bundgaard, Henning

    2014-05-21

    Several drugs used in the treatment of mental diseases are associated with an increased risk of sudden cardiac death (SCD). A general cause-relationship between the intake of these drugs and SCD is unattainable, but numerous case reports of drug-induced malignant arrhythmia and epidemiological studies, associating the use of specific drugs with SCD, strongly support the presence of an increased risk. Whereas the absolute risk of drug-induced life-threatening arrhythmia may be relatively low, even small increments in risk of SCD may have a major health impact considering that millions of patients are treated with psychotropics. In subgroups of pre-disposed patients, e.g. patients with cardiac diseases or other co-morbidities, the elderly or patients treated with other negatively interacting drugs, the absolute risk of drug-induced arrhythmia may be considerable. On the other hand, several of the major mental disorders are associated with a large risk of suicide if untreated. The observed risk of malignant arrhythmia associated with treatment with psychotropic drugs calls for clinical guidelines integrating the risk of the individual drug and other potentially interacting risk factors. In this review, data from various authorities on the risk of arrhythmia associated with psychotropic medications were weighted and categorized into three risk categories. Additionally, we suggest a clinically applicable algorithm to reduce the risk of malignant arrhythmia in patients to be treated with psychotropic medications. The algorithm integrates the risk categories of the individual drugs and pre-disposing risk factors and suggests a prudent follow-up for patients with an increased risk. We believe this clinically manageable guideline might improve safety in the many and rapidly increasing number of patients on psychotropic drugs.

  5. Syphilis Infection during Pregnancy: Fetal Risks and Clinical Management

    PubMed Central

    De Santis, Marco; De Luca, Carmen; Mappa, Ilenia; Spagnuolo, Terryann; Licameli, Angelo; Straface, Gianluca; Scambia, Giovanni

    2012-01-01

    Congenital syphilis is still a cause of perinatal morbidity and mortality. Untreated maternal infection leads to adverse pregnancy outcomes, including early fetal loss, stillbirth, prematurity, low birth weight, neonatal and infant death, and congenital disease among newborns. Clinical manifestations of congenital syphilis are influenced by gestational age, stage of maternal syphilis, maternal treatment, and immunological response of the fetus. It has been traditionally classified in early congenital syphilis and late congenital syphilis. Diagnosis of maternal infection is based on clinical findings, serological tests, and direct identification of treponemes in clinical specimens. Adequate treatment of maternal infection is effective for preventing maternal transmission to the fetus and for treating fetal infection. Prenatal diagnosis of congenital syphilis includes noninvasive and invasive diagnosis. Serological screening during pregnancy and during preconception period should be performed to reduce the incidence of congenital syphilis. PMID:22829747

  6. Decision theory and the evaluation of risks and benefits of clinical trials.

    PubMed

    Bernabe, Rosemarie D C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

    2012-12-01

    Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making. PMID:22819925

  7. Clinical validation of Braden and Bergstrom's conceptual schema of pressure sore risk factors.

    PubMed

    Copeland-Fields, L D; Hoshiko, B R

    1989-01-01

    Pressure sores are a health problem that crosses clinical practice settings. Today, emphasis is on prevention by identification of risk factors associated with pressure sore development. The Braden and Bergstrom (1987) schema of etiologies of pressure sores has been reported to be a useful predictor of client risk for pressure sore development. This clinical validation study examined relevance of the 13 schema factors to a rehabilitation setting. Using Fehring's (1986) validation model to analyze responses, the findings suggested that in the rehabilitation setting, four schema factors were critical risk factors (decreased mobility, decreased activity, decreased sensory perception, and increased friction), five were risk factors (increased moisture, increased shear, decreased nutrition, decreased arteriolar pressure, and decreased interstitial fluid flow), and four were not considered risk factors (increased age, emotional stress, smoking, and skin temperature). Fifteen additional risk factors, many of which are psychosocial, were suggested.

  8. Clinical prediction of fall risk and white matter abnormalities: a diffusion tensor imaging study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The Tinetti scale is a simple clinical tool designed to predict risk of falling by focusing on gait and stance impairment in elderly persons. Gait impairment is also associated with white matter (WM) abnormalities. Objective: To test the hypothesis that elderly subjects at risk for falling, as deter...

  9. Differential Profiles of Risk of Self-Harm among Clinically Referred Primary School Aged Children

    ERIC Educational Resources Information Center

    Angelkovska, Anne; Houghton, Stephen; Hopkins, Sarah

    2012-01-01

    Risk of self-harm among clinic referred children aged 6- to 12-years-old was investigated using the recently developed Self-Harm Risk Assessment for Children (SHRAC) instrument which comprises six factors: Affect traits; verbalizing of self-harm; socialization; dissociation; self-directing; and self-appraisal. The SHRAC was completed by the…

  10. VISUAL CONTRAST SENSITIVITY: A SENSITIVE INDICATOR OF NEUROTOXICITY FOR RISK ASSESSMENT AND CLINICAL APPLICATIONS.

    EPA Science Inventory

    Both human-health risk assessments of adverse effects from chronic, environmental exposures to neurotoxics and clinical practice are in need of objective indicators sensitive to the early stages of disruption in neurologic function; risk assessment for the purposes of hazard iden...

  11. Modeling progression risk for smoldering multiple myeloma: results from a prospective clinical study.

    PubMed

    Cherry, Benjamin M; Korde, Neha; Kwok, Mary; Manasanch, Elisabet E; Bhutani, Manisha; Mulquin, Marcia; Zuchlinski, Diamond; Yancey, Mary Ann; Maric, Irina; Calvo, Katherine R; Braylan, Raul; Stetler-Stevenson, Maryalice; Yuan, Constance; Tembhare, Prashant; Zingone, Adriana; Costello, Rene; Roschewski, Mark J; Landgren, Ola

    2013-10-01

    The risk of progression to multiple myeloma (MM) from the precursor condition smoldering MM (SMM) varies considerably among individual patients. Reliable markers for progression to MM are vital to advance the understanding of myeloma precursor disease and for the development of intervention trials designed to delay/prevent MM. The Mayo Clinic and Spanish PETHEMA have proposed models to stratify patient risk based on clinical parameters. The aim of our study was to define the degree of concordance between these two models by comparing the distribution of patients with SMM classified as low, medium and high risk for progression. A total of 77 patients with SMM were enrolled in our prospective natural history study. Per study protocol, each patient was assigned risk scores based on both the Mayo and the Spanish models. The Mayo Clinic model identified 38, 35 and four patients as low, medium and high risk, respectively. The Spanish PETHEMA model classified 17, 22 and 38 patients as low, medium and high risk, respectively. There was significant discordance in overall patient risk classification (28.6% concordance) and in classifying patients as low versus high (p < 0.0001), low versus non-low (p = 0.0007) and high versus non-high (p < 0.0001) risk. There is a need for prospectively validated models to characterize individual patient risk of transformation to MM. PMID:23311294

  12. Personalized Medicine Through SNP Testing for Breast Cancer Risk: Clinical Implementation.

    PubMed

    Howe, Rebecca; Miron-Shatz, Talya; Hanoch, Yaniv; Omer, Zehra B; O'Donoghue, Cristina; Ozanne, Elissa M

    2015-10-01

    Single nucleotide polymorphisms (SNPs) have the potential to improve personalized medicine in breast cancer care. As new SNPs are discovered, further enhancing risk classification, SNP testing may serve to complement family history and phenotypic risk factors when assessed in a clinical setting. SNP analysis is particularly relevant to high-risk women who may seek out such information to guide their decision-making around risk-reduction. However, little is known about how high-risk women may respond to SNP testing with regard to clinical decision-making. We examined high-risk women's interest in SNP testing for breast cancer risk through an online survey of hypothetical testing scenarios. Women stated their preferences for sharing test results and selected the most likely follow-up action they would pursue in each of the test result scenarios (above average and below average risk for breast cancer). Four hundred seventy-eight women participated. Most women (89 %) did not know what a SNP was prior to the study. Once SNP testing was described, 75 % were interested in SNP testing. Participants stated an interest in lifestyle interventions for risk-reduction and wanted to discuss their testing results with their doctor or a genetic counselor. Women are interested in SNP testing and are prepared to make lifestyle changes based on testing results. Women's preference for discussing testing results with a healthcare provider aligns with the current trend towards SNP testing in a clinical setting.

  13. Risk bodies: rehabilitation of sports patients in the physiotherapy clinic.

    PubMed

    Thing, Lone Friis

    2005-09-01

    This paper describes how body regimes are effectuated in the prevailing treatment strategy of physiotherapy. The process of self-mastering in the context of sports-related injuries is highlighted. Through a Foucauldian perspective on body regimes the aim is to shed light on the process of individualization and self-mastery in rehabilitation. The treatment of illness in the physiotherapy clinic does not characterize the patient as sick, and exempt the patient from daily duties and expectations. The empirical data include 17 qualitative illness narratives and several years of fieldwork observing patients with anterior cruciate ligament (ACL) injuries in a physiotherapy clinic. The study demonstrates how the expectation that the patients be active and self-mastering permeates the total process of treatment. The individual responsibility for personal well-being is a recurrent phenomenon in public health services in general, and specifically prominent in the rehabilitation of sports injuries.

  14. Providing pastoral care services in a clinical setting to veterans at-risk of suicide.

    PubMed

    Kopacz, Marek S

    2013-09-01

    The value of enhanced spiritual wellbeing has largely been overlooked as part of suicide prevention efforts in Veterans. The aim of this qualitative study is to examine the clinical pastoral care services provided by VA Chaplains to Veterans at-risk of suicide. This study was conducted using in-depth interviews with five Chaplains affiliated with a medical center located in upstate New York. This study was able to show that some at-risk individuals do actively seek out pastoral care, demonstrating a demand for such services. In conclusion, a pastoral care framework may already exist in some clinical settings, giving at-risk Veterans the opportunity to access spiritual care.

  15. Data-driven risk identification in phase III clinical trials using central statistical monitoring.

    PubMed

    Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

    2016-02-01

    Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CSM can be understood as a tool for providing a set of data-driven key risk indicators (KRIs), which help to organize adaptive targeted monitoring. Several case studies are provided where issues in a clinical trial have been identified thanks to targeted investigation after the identification of a risk using CSM. Using CSM to build data-driven KRIs helps to identify different kinds of issues in clinical trials. This ability is directly linked with the exhaustiveness of the CSM approach and its flexibility in the definition of the risks that are searched for when identifying the KRIs. In practice, a CSM assessment of the clinical database seems essential to ensure data quality. The atypical data patterns found in some centers and variables are seen as KRIs under a RBM approach. Targeted monitoring or data management queries can be used to confirm whether the KRIs point to an actual issue or not.

  16. Data-driven risk identification in phase III clinical trials using central statistical monitoring.

    PubMed

    Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

    2016-02-01

    Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CSM can be understood as a tool for providing a set of data-driven key risk indicators (KRIs), which help to organize adaptive targeted monitoring. Several case studies are provided where issues in a clinical trial have been identified thanks to targeted investigation after the identification of a risk using CSM. Using CSM to build data-driven KRIs helps to identify different kinds of issues in clinical trials. This ability is directly linked with the exhaustiveness of the CSM approach and its flexibility in the definition of the risks that are searched for when identifying the KRIs. In practice, a CSM assessment of the clinical database seems essential to ensure data quality. The atypical data patterns found in some centers and variables are seen as KRIs under a RBM approach. Targeted monitoring or data management queries can be used to confirm whether the KRIs point to an actual issue or not. PMID:26233672

  17. The influence of family history on prostate cancer risk: implications for clinical management.

    PubMed

    Madersbacher, Stephan; Alcaraz, Antonio; Emberton, Mark; Hammerer, Peter; Ponholzer, Anton; Schröder, Fritz H; Tubaro, Andrea

    2011-03-01

    • The most recent evidence for the link between a family history of prostate cancer and individual risk for future disease was examined, with the aim of understanding what the existence and nature of a family history of prostate cancer does to a man's risk of developing the disease. • Our findings highlighted the clear association between a family history of prostate cancer and increased risk of developing the disease; with a greater proximity of relatedness, greater number of family members affected and/or earlier age at diagnosis of the family member elevating risk further. • These findings have important clinical implications for the identification and subsequent management of men deemed to be at increased risk of developing prostate cancer. The evidence for prostate cancer risk reduction with the mono 5α-reductase inhibitor (5ARI) finasteride in a low-risk population and, more recently, with the dual 5ARI dutasteride in a population at increased risk of developing the disease, has potential to expand management options for men at risk of developing prostate cancer beyond more frequent and/or earlier surveillance. • Given that family history can be easily assessed in routine clinical practice, it should be regarded as an important parameter to consider alongside PSA level for prostate cancer risk assessment. PMID:21166744

  18. Clinical relevance of nalmefene versus placebo in alcohol treatment: Reduction in mortality risk

    PubMed Central

    Roerecke, Michael; Sørensen, Per; Laramée, Philippe; Rahhali, Nora; Rehm, Jürgen

    2015-01-01

    Reduction of long-term mortality risk, an important clinical outcome for people in alcohol dependence treatment, can rarely be established in randomized controlled trials (RCTs). We calculated the reduction in all-cause mortality risk using data from short-term (6 and 12 months) double-blind RCTs comparing as-needed nalmefene treatment to placebo, and mortality risks from meta-analyses on all-cause-mortality risk by reduction of drinking in people with alcohol dependence. A reduction in drinking in the RCTs was defined by shifts in drinking risk levels established by the European Medicines Agency. Results showed that the reduction of drinking in the nalmefene group was associated with a reduction in mortality risk by 8% (95% CI: 2%, 13%) when compared to the placebo group. Sensitivity analyses confirmed a significant effect. Thus comparing the difference between nalmefene and placebo in reduction in drinking levels with results on all-cause mortality risk from meta-analyses indicated a clinically relevant reduction in mortality risk. Given the high mortality risk of people with alcohol dependence, abstinence or a reduction in drinking have been shown to reduce mortality risk and should be considered treatment goals. PMID:26349557

  19. Clinical relevance of nalmefene versus placebo in alcohol treatment: reduction in mortality risk.

    PubMed

    Roerecke, Michael; Sørensen, Per; Laramée, Philippe; Rahhali, Nora; Rehm, Jürgen

    2015-11-01

    Reduction of long-term mortality risk, an important clinical outcome for people in alcohol dependence treatment, can rarely be established in randomized controlled trials (RCTs). We calculated the reduction in all-cause mortality risk using data from short-term (6 and 12 months) double-blind RCTs comparing as-needed nalmefene treatment to placebo, and mortality risks from meta-analyses on all-cause-mortality risk by reduction of drinking in people with alcohol dependence. A reduction in drinking in the RCTs was defined by shifts in drinking risk levels established by the European Medicines Agency. Results showed that the reduction of drinking in the nalmefene group was associated with a reduction in mortality risk by 8% (95% CI: 2%, 13%) when compared to the placebo group. Sensitivity analyses confirmed a significant effect. Thus comparing the difference between nalmefene and placebo in reduction in drinking levels with results on all-cause mortality risk from meta-analyses indicated a clinically relevant reduction in mortality risk. Given the high mortality risk of people with alcohol dependence, abstinence or a reduction in drinking have been shown to reduce mortality risk and should be considered treatment goals.

  20. Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials

    PubMed Central

    Lantos, John D.; Wendler, David; Septimus, Edward; Wahba, Sarita; Madigan, Rosemary; Bliss, Geraldine

    2015-01-01

    The classification system for categorizing the riskiness of a clinical trial is largely defined by the body of federal regulations known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration (FDA) codified in 21 CFR 50. This rule is applied according to the interpretation of institutional review boards (IRBs) charged with overseeing the research. If a clinical trial is determined by an IRB to constitute “minimal risk,” there are important practical implications: the IRB may allow waiver or alteration of the informed consent process; the study may be carried out in certain vulnerable populations; or the study may be reviewed by IRBs using an expedited process. However, it is unclear how the risk levels of pragmatic clinical trials (PCTs) should be assessed. Such trials typically compare existing, widely used medical therapies or interventions in the setting of routine clinical practice. Some of the therapies may be considered risky of themselves but the study comparing them may or may not add to that pre-existing level of risk. In this paper, we examine current research regulations and common interpretations of those regulations and suggest that current interpretation and application of regulations governing minimal-risk classification are marked by a high degree of variability and confusion, which in turn may ultimately harm patients by delaying or hindering potentially beneficial research. We advocate for a clear differentiation between the risks associated with a given therapy and the incremental risk incurred during research evaluating those therapies as a basic principle for evaluating the risk of a clinical study. We then examine two studies that incorporate aspects of PCTs and consider how various factors including patient perspectives, clinical equipoise, practice variation, and research methods such as cluster randomization contribute to current and evolving concepts of minimal risk, and how this

  1. Teledermatology and clinical photography: safeguarding patient privacy and mitigating medico-legal risk.

    PubMed

    Stevenson, Paul; Finnane, Anna R; Soyer, H Peter

    2016-03-21

    Capturing clinical images is becoming more prevalent in everyday clinical practice, and dermatology lends itself to the use of clinical photographs and teledermatology. "Store-and-forward", whereby clinical images are forwarded to a specialist who later responds with an opinion on diagnosis and management is a popular form of teledermatology. Store-and-forward teledermatology has proven accurate and reliable, accelerating the process of diagnosis and treatment and improving patient outcomes. Practitioners' personal smartphones and other devices are often used to capture and communicate clinical images. Patient privacy can be placed at risk with the use of this technology. Practitioners should obtain consent for taking images, explain how they will be used, apply appropriate security in their digital communications, and delete images and other data on patients from personal devices after saving these to patient health records. Failing to use appropriate security precautions poses an emerging medico-legal risk for practitioners.

  2. Teledermatology and clinical photography: safeguarding patient privacy and mitigating medico-legal risk.

    PubMed

    Stevenson, Paul; Finnane, Anna R; Soyer, H Peter

    2016-03-21

    Capturing clinical images is becoming more prevalent in everyday clinical practice, and dermatology lends itself to the use of clinical photographs and teledermatology. "Store-and-forward", whereby clinical images are forwarded to a specialist who later responds with an opinion on diagnosis and management is a popular form of teledermatology. Store-and-forward teledermatology has proven accurate and reliable, accelerating the process of diagnosis and treatment and improving patient outcomes. Practitioners' personal smartphones and other devices are often used to capture and communicate clinical images. Patient privacy can be placed at risk with the use of this technology. Practitioners should obtain consent for taking images, explain how they will be used, apply appropriate security in their digital communications, and delete images and other data on patients from personal devices after saving these to patient health records. Failing to use appropriate security precautions poses an emerging medico-legal risk for practitioners. PMID:26985853

  3. Working with Asian American Youth at Clinical High Risk for Psychosis: A Case Illustration

    PubMed Central

    Li, Huijun; Friedman-Yakoobian, Michelle; Min, Grace; Granato, Andréa Gnong; Seidman, Larry J.

    2013-01-01

    The idea of a clinical high risk (CHR) for psychosis has focused attention on early intervention to prevent or attenuate psychosis. However, many clinicians may still not be very familiar with the concept of CHR. Current studies have not allowed for an in-depth examination of the challenges and strategies of working with youth from the range of racial/ethnic minority families, Asian American families in particular. The purpose of this paper is three fold. First, we critically review Asian cultural values and beliefs about mental illness, psychosis in particular, while highlighting specific challenges that Asian American families encounter. Second, we provide a clinical case to illustrate these challenges and inform clinical practice when working with Asian youth at risk for psychosis and their families. Third, practical and easy-to-follow clinical strategies are provided. Implications for clinical practice and directions for future research are presented. PMID:23689196

  4. Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes.

    PubMed

    Sakamoto, Shinji; Takaki, Manabu; Okahisa, Yuko; Mizuki, Yutaka; Inagaki, Masatoshi; Ujike, Hiroshi; Mitsuhashi, Toshiharu; Takao, Soshi; Ikeda, Masashi; Uchitomi, Yosuke; Iwata, Nakao; Yamada, Norihito

    2016-04-01

    Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study. PMID:26674612

  5. Clinical risk predictors associated with cardiac mortality following vascular surgery in South African patients.

    PubMed

    Biccard, B M; Bandu, R

    2007-01-01

    Clinical risk prediction is important in the prognostication of peri-operative cardiac complications and the management of high-risk cardiac patients for major non-cardiac surgery. However, the current pre-operative clinical risk indices have been derived in European and American patients and not validated in South African patients. The purpose of this study was to evaluate the utility of the clinical risk predictors identified in Lee's revised cardiac risk index and in the African arm of the INTERHEART study, in predicting cardiac mortality following vascular surgery in South African patients. A retrospective cohort study was conducted of all patients undergoing elective or urgent vascular surgery at Inkosi Albert Luthuli Central Hospital over a three-year period. All in-hospital deaths were identified and classified into cardiac or non-cardiac deaths by an investigator blinded to the patients' pre-operative clinical risk predicators. A second investigator blinded to the cause of death identified the following clinical risk predictors: history of ischaemic heart disease, congestive cardiac failure and cerebrovascular accident, presence of diabetes, hypertension and obesity (BMI > 30 kg.m(-2)), elevated serum creatinine (> 180 micromol.l(-1)), positive smoking history and ethnicity. The main finding was that a serum creatinine level of greater than 180 micromol.l(-1) and a positive smoking history were significantly associated with cardiac death (p = 0.012, p = 0.012, respectively). Multivariate analyses using a backward stepwise modeling technique found only a serum creatinine of > 180 micromol.l(-1) and a positive smoking history to be significantly associated with cardiac mortality (p = 0.038, 0.035, respectively) with an odds ratio and 95% confidence interval of 3.02 (1.06-8.59) and 3.40 (1.09-10.62), respectively. All other clinical predictors were not significantly different between the two groups. However, based on the sample size of this study, a type 2 or

  6. Assessment of volatile organic compounds and particulate matter in a dental clinic and health risks to clinic personnel.

    PubMed

    Hong, Yu-Jue; Huang, Yen-Ching; Lee, I-Long; Chiang, Che-Ming; Lin, Chitsan; Jeng, Hueiwang Anna

    2015-01-01

    This study was conducted to assess (1) levels of volatile organic compounds (VOCs) and particulate matter (PM) in a dental clinic in southern Taiwan and (2) dental care personnel's health risks associated with due to chronic exposure to VOCs. An automatic, continuous sampling system and a multi-gas monitor were employed to quantify the air pollutants, along with environmental comfort factors, including temperature, CO2, and relative humidity at six sampling sites in the clinic over eight days. Specific VOC compounds were identified and their concentrations were quantified. Both non-carcinogenic and carcinogenic VOC compounds were assessed based on the US Environmental Protection Agency's Principles of Health Risk Assessment in terms of whether those indoor air pollutants increased health risks for the full-time dental care professionals at the clinic. Increased levels of VOCs were recorded during business hours and exceeded limits recommended by the Taiwan Environmental Protection Agency. A total of 68 VOC compounds were identified in the study area. Methylene methacrylate (2.8 ppm) and acetone (0.176 ppm) were the only two non-carcinogenic compounds that posed increased risks for human health, yielding hazard indexes of 16.4 and 4.1, respectively. None of the carcinogenic compounds increased cancer risk. All detected PM10 levels ranged from 20 to 150 μg/m(3), which met the Taiwan EPA and international limits. The average PM10 level during business hours was significantly higher than that during non-business hours (P = 0.04). Improved ventilation capacity in the air conditioning system was recommended to reduce VOCs and PM levels. PMID:26301846

  7. Genomic risk prediction of complex human disease and its clinical application.

    PubMed

    Abraham, Gad; Inouye, Michael

    2015-08-01

    Recent advances in genome-wide association studies have stimulated interest in the genomic prediction of disease risk, potentially enabling individual-level risk estimates for early intervention and improved diagnostic procedures. Here, we review recent findings and approaches to genomic prediction model construction and performance, then contrast the potential benefits of such models in two complex human diseases, aiding diagnosis in celiac disease and prospective risk prediction for cardiovascular disease. Early indications are that optimal application of genomic risk scores will differ substantially for each disease depending on underlying genetic architecture as well as current clinical and public health practice. As costs decline, genomic profiles become common, and popular understanding of risk and its communication improves, genomic risk will become increasingly useful for the individual and the clinician.

  8. Type 2 diabetes in children: Clinical aspects and risk factors.

    PubMed

    Rao, P V

    2015-04-01

    A strong link between obesity, insulin resistance, and metabolic syndrome has been reported with development of a new paradigm to type 2 diabetes mellitus (T2DM), with some evidence suggesting that beta-cell dysfunction is present before the onset of impaired glucose tolerance. Differentiating type 1 diabetes mellitus (T1DM) from T2DM is actually not very easy and there exists a number of overlapping characteristics. The autoantibody frequencies of seven antigens in T1DM patients may turn out to be actually having T2DM patients (pre-T2DM). T2DM patients generally have increased C-peptide levels (may be normal at time of diagnosis), usually no auto-antibodies, strong family history of diabetes, obese and show signs of insulin resistance (hypertension, acanthosis, PCOS). The American Academy of Paediatrics recommends lifestyle modifications ± metformin when blood glucose is 126-200 mg/dL and hemoglobin A1c (HbA1c) <8.5. Insulin is recommended when blood glucose is >200 mg/dL and HbA1c >8.5, with or without ketosis. Metformin is not recommended if the patient is ketotic, because this increases the risk of lactic acidosis. Metformin is currently the only oral hypoglycemic that has been approved for use in children. Knowing these subtle differences in mechanism, and knowing how to test patients for which mechanism (s) are causing their diabetes mellitus, may help us eventually tailor treatment programs on an individual basis.

  9. Type 2 diabetes in children: Clinical aspects and risk factors.

    PubMed

    Rao, P V

    2015-04-01

    A strong link between obesity, insulin resistance, and metabolic syndrome has been reported with development of a new paradigm to type 2 diabetes mellitus (T2DM), with some evidence suggesting that beta-cell dysfunction is present before the onset of impaired glucose tolerance. Differentiating type 1 diabetes mellitus (T1DM) from T2DM is actually not very easy and there exists a number of overlapping characteristics. The autoantibody frequencies of seven antigens in T1DM patients may turn out to be actually having T2DM patients (pre-T2DM). T2DM patients generally have increased C-peptide levels (may be normal at time of diagnosis), usually no auto-antibodies, strong family history of diabetes, obese and show signs of insulin resistance (hypertension, acanthosis, PCOS). The American Academy of Paediatrics recommends lifestyle modifications ± metformin when blood glucose is 126-200 mg/dL and hemoglobin A1c (HbA1c) <8.5. Insulin is recommended when blood glucose is >200 mg/dL and HbA1c >8.5, with or without ketosis. Metformin is not recommended if the patient is ketotic, because this increases the risk of lactic acidosis. Metformin is currently the only oral hypoglycemic that has been approved for use in children. Knowing these subtle differences in mechanism, and knowing how to test patients for which mechanism (s) are causing their diabetes mellitus, may help us eventually tailor treatment programs on an individual basis. PMID:25941651

  10. QuickSilver Clinical Tracker – a Risk-Management Approach

    PubMed Central

    Rosenthal, Daniel T.; Chueh, Henry

    2003-01-01

    While many guidelines strive to automate the high-granular clinical thought process, the resulting risk stratification is often a lowgranular management class (i.e. low, medium or high risk). Furthermore, the “low hanging fruit” of guidelines is not in decision support, rather in the subsequent action tracking. Therefore, we believe that only a small amount of data is required to produce significant reminders. In our approach, the clinician risk-stratifies the patient and enters the guideline at the management level. We do not attempt to replicate the clinical thought process; rather we ask the question, “Now that you have decided, how can we help track your decisions?” A risk-management approach encapsulates salient guideline features and provides a framework for basic decision support and data tracking. PMID:14728492

  11. A novel neural-inspired learning algorithm with application to clinical risk prediction.

    PubMed

    Tay, Darwin; Poh, Chueh Loo; Kitney, Richard I

    2015-04-01

    Clinical risk prediction - the estimation of the likelihood an individual is at risk of a disease - is a coveted and exigent clinical task, and a cornerstone to the recommendation of life saving management strategies. This is especially important for individuals at risk of cardiovascular disease (CVD) given the fact that it is the leading causes of death in many developed counties. To this end, we introduce a novel learning algorithm - a key factor that influences the performance of machine learning-based prediction models - and utilities it to develop CVD risk prediction tool. This novel neural-inspired algorithm, called the Artificial Neural Cell System for classification (ANCSc), is inspired by mechanisms that develop the brain and empowering it with capabilities such as information processing/storage and recall, decision making and initiating actions on external environment. Specifically, we exploit on 3 natural neural mechanisms responsible for developing and enriching the brain - namely neurogenesis, neuroplasticity via nurturing and apoptosis - when implementing ANCSc algorithm. Benchmark testing was conducted using the Honolulu Heart Program (HHP) dataset and results are juxtaposed with 2 other algorithms - i.e. Support Vector Machine (SVM) and Evolutionary Data-Conscious Artificial Immune Recognition System (EDC-AIRS). Empirical experiments indicate that ANCSc algorithm (statistically) outperforms both SVM and EDC-AIRS algorithms. Key clinical markers identified by ANCSc algorithm include risk factors related to diet/lifestyle, pulmonary function, personal/family/medical history, blood data, blood pressure, and electrocardiography. These clinical markers, in general, are also found to be clinically significant - providing a promising avenue for identifying potential cardiovascular risk factors to be evaluated in clinical trials.

  12. Risk Factors and Clinical Outcomes in Preterm Infants with Pulmonary Hypertension

    PubMed Central

    Collaco, Joseph M.; Dadlani, Gul H.; Nies, Melanie K.; Leshko, Jenny; Everett, Allen D.; McGrath-Morrow, Sharon A.

    2016-01-01

    Background Pulmonary hypertension (PH) is a significant cause of morbidity in preterm infants, but no screening guidelines exist. We sought to identify risk factors and clinical outcomes associated with PH in preterm infants to develop a PH risk score. Methods Retrospective analysis of two separate populations of preterm infants (NICU cohort n = 230; Clinic registry n = 580). Results 8.3% of the NICU cohort had PH after 4 weeks of age, while 14.8% of the clinic registry had PH after 2 months of age. Lower birth weights and longer initial hospitalizations were associated with PH in both populations (p<0.001 for all tests). Using adjusted logistic regression, patent ductus arteriosus (PDA) requiring ligation was associated with PH in both the NICU cohort (OR: 3.19; p = 0.024) and the clinic registry (OR: 2.67; p<0.001). Risk factors (birth weight ≤780 grams, home supplemental oxygen use, and PDA ligation) identified in the clinic registry (training dataset) were validated in the NICU cohort with 0–1 factors present were associated with ≤1.5% probability of having PH, any 2 factors with a 25% probability, and all 3 factors with a 40% probability. Conclusions Lower birth weight, PDA ligation, and respiratory support were associated with PH in both populations. A PH risk score based on clinical indicators from the training dataset predicted PH in the validation set. This risk score could help focus resources to preterm infants at higher risk for PH. Further work is needed to determine whether earlier or more aggressive management of ductal lesions could alter PH outcomes. PMID:27716811

  13. Clinical Pathways as Instruments for Risk and Cost Management in Hospitals - A Discussion Paper

    PubMed Central

    Romeyke, Tobias; Stummer, Harald

    2012-01-01

    Introduction: The distinctive characteristics of the German health system are medical progress and financial pressure—and this is especially true of the hospitals. These challenges must be met by strategic management instruments for quality assurance, and by reducing costs. Purpose: This article presents the instrument “clinical pathway” (also known as “clinical treatment pathway”) and describes the possibilities it offers, both for quality assurance and risk management, and for cost reduction. The clinical pathway presented here will be that for “multimodal pain therapy”, as used in the context of acute inpatient care in Germany. Methods: A general presentation of the risks in hospital is followed by consideration of the risks associated with core processes. A comprehensive total cost analysis is performed for those patients who meet the pathway entry criteria and who fulfil the requirements for the structure of care provided within multimodal pain therapy. Discussion and Conclusion: Multimodal pain therapy places high demands on the structural, procedural and outcome quality of the medical, nursing and therapeutic services provided, and these demands are reflected in high costs for the provision of this care. The treatment process involves many different professional groups. These complex interfaces can potentially generate risks, which can lead to the possibility of legal liability. A clinical pathway must structure the core process and then combine elements of quality assurance in order to optimise patient care and minimise risk. The examination of costs reveals significant potential savings (patients with clinical pathway: EUR 3086±212; patients without clinical pathway: EUR 3774±460; Mann-Whitney U test; p<0.001). For the managers of a hospital, the clinical pathway represents a strategic management instrument that can serve for continual cost control and cost reduction, and can contribute in the form of quality assurance towards a transparent

  14. Clinical values dataset processing through cluster analysis to find cardiovascular risk

    NASA Astrophysics Data System (ADS)

    Bucci, C. M.; Legnani, W. E.; Armentano, R. L.

    2016-04-01

    The scope of this work is to show another way to grouping population with clinical variables measured in health centres and to assign a cardiovascular risk indicator. To do this, two different datasets were used, one coming from France and another coming from Uruguay. The well proved Framingham index was used to validate the results. The preliminary results are very auspicious to encourage the research and get deeper knowledge of the cardiovascular risk indicators.

  15. Predicting the risk of mild cognitive impairment in the Mayo Clinic Study of Aging

    PubMed Central

    Pankratz, V. Shane; Roberts, Rosebud O.; Mielke, Michelle M.; Knopman, David S.; Jack, Clifford R.; Geda, Yonas E.; Rocca, Walter A.

    2015-01-01

    Objective: We sought to develop risk scores for the progression from cognitively normal (CN) to mild cognitive impairment (MCI). Methods: We recruited into a longitudinal cohort study a randomly selected, population-based sample of Olmsted County, MN, residents, aged 70 to 89 years on October 1, 2004. At baseline and subsequent visits, participants were evaluated for demographic, clinical, and neuropsychological measures, and were classified as CN, MCI, or dementia. Using baseline demographic and clinical variables in proportional hazards models, we derived scores that predicted the risk of progressing from CN to MCI. We evaluated the ability of these risk scores to classify participants for MCI risk. Results: Of 1,449 CN participants, 401 (27.7%) developed MCI. A basic model had a C statistic of 0.60 (0.58 for women, 0.62 for men); an augmented model resulted in a C statistic of 0.70 (0.69 for women, 0.71 for men). Both men and women in the highest vs lowest sex-specific quartiles of the augmented model's risk scores had an approximately 7-fold higher risk of developing MCI. Adding APOE ε4 carrier status improved the model (p = 0.002). Conclusions: We have developed MCI risk scores using variables easily assessable in the clinical setting and that may be useful in routine patient care. Because of variability among populations, validation in independent samples is required. These models may be useful in identifying patients who might benefit from more expensive or invasive diagnostic testing, and can inform clinical trial design. Inclusion of biomarkers or other risk factors may further enhance the models. PMID:25788555

  16. Evaluation of the modifying effects of unfavourable genotypes on classical clinical risk factors for ischaemic stroke

    PubMed Central

    Szolnoki, Z; Somogyvari, F; Kondacs, A; Szabo, M; Fodor, L; Bene, J; Melegh, B

    2003-01-01

    Objectives: Ischaemic stroke is a frequent heterogeneous multifactorial disease that is affected by a number of genetic mutations and environmental factors. We hypothesised the clinical importance of the interactions between common, unfavourable genetic mutations and clinical risk factors in the development of ischaemic stroke. Methods: The Factor V Leiden G1691A (Leiden V), the prothrombin G20210A, the methylenetetrahydrofolate reductase C677T (MTHFR C677T) mutations, the angiotensin converting enzyme I/D (ACE I/D), and apolipoprotein allele e4 (APO e4) genotypes were examined by the polymerase chain reaction (PCR) technique in 867 ischaemic stroke patients and 743 healthy controls. Logistic regression models were used to estimate the roles of the co-occurrences of the clinical risk factors and common genetic mutations in ischaemic stroke. Results: The Leiden V mutation in combination with hypertension or diabetes mellitus increased the risk of ischaemic stroke. We found synergistic effects between the ACE D/D and MTHFR 677TT genotypes and drinking or smoking. The presence of the APO e4 greatly facilitated the unfavourable effects of hypertension, diabetes mellitus, smoking, or drinking on the incidence of ischaemic stroke. Conclusion: In certain combinations, pairing of common unfavourable genetic factors, which alone confer only minor or non-significant risk, with clinical risk factors can greatly increase the susceptibility to ischaemic stroke. PMID:14638877

  17. Nursing Diagnosis Risk for falls: prevalence and clinical profile of hospitalized patients1

    PubMed Central

    Luzia, Melissa de Freitas; Victor, Marco Antonio de Goes; Lucena, Amália de Fátima

    2014-01-01

    Objectives to identify the prevalence of the Nursing Diagnosis (ND) Risk for falls in the hospitalizations of adult patients in clinical and surgical units, to characterize the clinical profile and to identify the risk factors of the patients with this ND. Method a cross-sectional study with 174 patients. The data was collected from the computerized nursing care prescriptions system and on-line hospital records, and analyzed statistically. Results the prevalence of the ND Risk for falls was 4%. The patients' profile indicated older adults, males (57%), those hospitalized in the clinical units (63.2%), with a median length of hospitalization of 20 (10-24) days, with neurological illnesses (26%), cardio-vascular illnesses (74.1%) and various co-morbidities (3±1.8). The prevalent risk factors were neurological alterations (43.1%), impaired mobility (35.6%) and extremes of age (10.3%). Conclusion the findings contributed to evidencing the profile of the patients with a risk of falling hospitalized in clinical and surgical wards, which favors the planning of interventions for preventing this adverse event. PMID:26107834

  18. Youth-caregiver Agreement on Clinical High-risk Symptoms of Psychosis

    PubMed Central

    Golembo-Smith, Shana; Bachman, Peter; Senturk, Damla; Cannon, Tyrone D.; Bearden, Carrie E.

    2014-01-01

    Early identification of individuals who will go on to develop schizophrenia is a difficult endeavor. The variety of symptoms experienced by clinical high-risk youth make it difficult to identify who will eventually develop schizophrenia in the future. Efforts are being made, therefore, to more accurately identify at-risk individuals and factors that predict conversion to psychosis. As in most assessments of children and adolescents, however, both youth and parental report of symptomatology and resulting dysfunction are important to assess. The goals of the current study were to assess the extent of cross-informant agreement on the Structured Interview for Prodromal Symptoms (SIPS), a widely-used tool employed to determine clinical high-risk status. A total of 84 youth-caregiver pairs participated. Youth and caregiver raters displayed moderate overall agreement on SIPS-rated symptoms. Both youth and caregiver ratings of youth symptomatology contributed significantly to predicting conversion to psychosis. In addition, youth age and quality of youth-caregiver relationships appear to be related to cross-informant symptom ratings. Despite differences on individual SIPS domains, the majority of dyads agreed on youth clinical high-risk status. Results highlight the potential clinical utility of using caregiver informants to determine youth psychosis risk. PMID:24092494

  19. External model validation of binary clinical risk prediction models in cardiovascular and thoracic surgery.

    PubMed

    Hickey, Graeme L; Blackstone, Eugene H

    2016-08-01

    Clinical risk-prediction models serve an important role in healthcare. They are used for clinical decision-making and measuring the performance of healthcare providers. To establish confidence in a model, external model validation is imperative. When designing such an external model validation study, thought must be given to patient selection, risk factor and outcome definitions, missing data, and the transparent reporting of the analysis. In addition, there are a number of statistical methods available for external model validation. Execution of a rigorous external validation study rests in proper study design, application of suitable statistical methods, and transparent reporting.

  20. Barrett’s Esophagus and Cancer Risk: How Research Advances Can Impact Clinical Practice

    PubMed Central

    di Pietro, Massimiliano; Alzoubaidi, Durayd; Fitzgerald, Rebecca C.

    2014-01-01

    Barrett’s esophagus (BE) is the only known precursor to esophageal adenocarcinoma (EAC), whose incidence has increased sharply in the last 4 decades. The annual conversion rate of BE to cancer is significant, but small. The identification of patients at a higher risk of cancer therefore poses a clinical conundrum. Currently, endoscopic surveillance is recommended in BE patients, with the aim of diagnosing either dysplasia or cancer at early stages, both of which are curable with minimally invasive endoscopic techniques. There is a large variation in clinical practice for endoscopic surveillance, and dysplasia as a marker of increased risk is affected by sampling error and high interobserver variability. Screening programs have not yet been formally accepted, mainly due to the economic burden that would be generated by upper gastrointestinal endoscopy. Screening programs have not yet been formally accepted, mainly due to the economic burden that would be generated by widespread indication to upper gastrointestinal endoscopy. In fact, it is currently difficult to formulate an accurate algorithm to confidently target the population at risk, based on the known clinical risk factors for BE and EAC. This review will focus on the clinical and molecular factors that are involved in the development of BE and its conversion to cancer and on how increased knowledge in these areas can improve the clinical management of the disease. PMID:25071900

  1. Cardiovascular risk and combined oral contraceptives: clinical decisions in settings of uncertainty.

    PubMed

    Beller, Jennifer P; McCartney, Christopher R

    2013-01-01

    Although generally safe, combined oral contraceptives (COCs) are associated with risks, including an estimated 2-fold increased relative risk of cardiovascular events. For most women taking COCs for contraception, absolute cardiovascular risks are very low, and the overall risks of COCs are outweighed by the risks of unwanted pregnancy. Nonetheless, risks of COCs may be excessive in some women, and both the American College of Obstetricians (ACOG) and the World Health Organization (WHO) have offered contraindications for COC use. Complicating this issue, COCs are commonly used for reasons other than contraception (eg, polycystic ovary syndrome, which is associated with subfertility and cardiovascular risk factors). Thus, in some clinical scenarios, ACOG and WHO guidelines may offer incomplete guidance regarding whether COC use would be associated with an unacceptable risk-benefit ratio. We propose that cardiovascular risk calculators may be helpful in some patients, as an adjunct to ACOG and WHO guidelines, by allowing physicians to estimate the attributable risk of COC-related cardiovascular events.

  2. Integrating clinical features and genetic lesions in the risk assessment of patients with chronic myelomonocytic leukemia

    PubMed Central

    Elena, Chiara; Gallì, Anna; Such, Esperanza; Meggendorfer, Manja; Germing, Ulrich; Rizzo, Ettore; Cervera, Jose; Molteni, Elisabetta; Fasan, Annette; Schuler, Esther; Ambaglio, Ilaria; Lopez-Pavia, Maria; Zibellini, Silvia; Kuendgen, Andrea; Travaglino, Erica; Sancho-Tello, Reyes; Catricalà, Silvia; Vicente, Ana I.; Haferlach, Torsten; Haferlach, Claudia; Sanz, Guillermo F.; Cazzola, Mario

    2016-01-01

    Chronic myelomonocytic leukemia (CMML) is a myelodysplastic/myeloproliferative neoplasm with variable clinical course. To predict the clinical outcome, we previously developed a CMML-specific prognostic scoring system (CPSS) based on clinical parameters and cytogenetics. In this work, we tested the hypothesis that accounting for gene mutations would further improve risk stratification of CMML patients. We therefore sequenced 38 genes to explore the role of somatic mutations in disease phenotype and clinical outcome. Overall, 199 of 214 (93%) CMML patients carried at least 1 somatic mutation. Stepwise linear regression models showed that these mutations accounted for 15% to 24% of variability of clinical phenotype. Based on multivariable Cox regression analyses, cytogenetic abnormalities and mutations in RUNX1, NRAS, SETBP1, and ASXL1 were independently associated with overall survival (OS). Using these parameters, we defined a genetic score that identified 4 categories with significantly different OS and cumulative incidence of leukemic evolution. In multivariable analyses, genetic score, red blood cell transfusion dependency, white blood cell count, and marrow blasts retained independent prognostic value. These parameters were included into a clinical/molecular CPSS (CPSS-Mol) model that identified 4 risk groups with markedly different median OS (from >144 to 18 months, hazard ratio [HR] = 2.69) and cumulative incidence of leukemic evolution (from 0% to 48% at 4 years, HR = 3.84) (P < .001). The CPSS-Mol fully retained its ability to risk stratify in an independent validation cohort of 260 CMML patients. In conclusion, integrating conventional parameters and gene mutations significantly improves risk stratification of CMML patients, providing a robust basis for clinical decision-making and a reliable tool for clinical trials. PMID:27385790

  3. An automatic system to identify heart disease risk factors in clinical texts over time.

    PubMed

    Chen, Qingcai; Li, Haodi; Tang, Buzhou; Wang, Xiaolong; Liu, Xin; Liu, Zengjian; Liu, Shu; Wang, Weida; Deng, Qiwen; Zhu, Suisong; Chen, Yangxin; Wang, Jingfeng

    2015-12-01

    Despite recent progress in prediction and prevention, heart disease remains a leading cause of death. One preliminary step in heart disease prediction and prevention is risk factor identification. Many studies have been proposed to identify risk factors associated with heart disease; however, none have attempted to identify all risk factors. In 2014, the National Center of Informatics for Integrating Biology and Beside (i2b2) issued a clinical natural language processing (NLP) challenge that involved a track (track 2) for identifying heart disease risk factors in clinical texts over time. This track aimed to identify medically relevant information related to heart disease risk and track the progression over sets of longitudinal patient medical records. Identification of tags and attributes associated with disease presence and progression, risk factors, and medications in patient medical history were required. Our participation led to development of a hybrid pipeline system based on both machine learning-based and rule-based approaches. Evaluation using the challenge corpus revealed that our system achieved an F1-score of 92.68%, making it the top-ranked system (without additional annotations) of the 2014 i2b2 clinical NLP challenge. PMID:26362344

  4. An automatic system to identify heart disease risk factors in clinical texts over time.

    PubMed

    Chen, Qingcai; Li, Haodi; Tang, Buzhou; Wang, Xiaolong; Liu, Xin; Liu, Zengjian; Liu, Shu; Wang, Weida; Deng, Qiwen; Zhu, Suisong; Chen, Yangxin; Wang, Jingfeng

    2015-12-01

    Despite recent progress in prediction and prevention, heart disease remains a leading cause of death. One preliminary step in heart disease prediction and prevention is risk factor identification. Many studies have been proposed to identify risk factors associated with heart disease; however, none have attempted to identify all risk factors. In 2014, the National Center of Informatics for Integrating Biology and Beside (i2b2) issued a clinical natural language processing (NLP) challenge that involved a track (track 2) for identifying heart disease risk factors in clinical texts over time. This track aimed to identify medically relevant information related to heart disease risk and track the progression over sets of longitudinal patient medical records. Identification of tags and attributes associated with disease presence and progression, risk factors, and medications in patient medical history were required. Our participation led to development of a hybrid pipeline system based on both machine learning-based and rule-based approaches. Evaluation using the challenge corpus revealed that our system achieved an F1-score of 92.68%, making it the top-ranked system (without additional annotations) of the 2014 i2b2 clinical NLP challenge.

  5. Do bib clips pose a cross-contamination risk at the dental clinic?

    PubMed

    Alt-Holland, Addy; Srinivasan, Sreedevi; Lucier, Rebekah; Kublin, Claire L; Fong, Jennifer M; Goldfein, Joshua; Baker, David L; Park, Angel; Finkelman, Matthew; Kawai, Toshihisa; Paster, Bruce J; Kugel, Gerard

    2012-07-01

    Although multiple-use dental napkin holders have a relatively low risk of transmitting infection, they do require disinfection between patients. This study sought to: 1) determine the presence of bacterial load on two types of clips of reusable bib chains after dental procedures at the Endodontics and Orthodontics clinics at Tufts University School of Dental Medicine; and 2) evaluate the effectiveness of disinfecting the clips. These specialty clinics represent a wide spectrum of patients, procedures, and appointment times. Bacterial load on the bib clips was determined immediately following dental treatments-both before and after their disinfection-during morning and afternoon sessions. The results revealed that, after treatments, there was a statistically significant difference when comparing the two clinics for bacterial burden on the clips. Furthermore, there was a statistically significant difference in bacterial load on the two types of clips. Disinfection of the bib clips was highly effective in both clinics. Clinically, the results suggest that due to the nature of the treatment, the demographic population, and the type of bib clips used, patients in different clinics may be exposed to varying bacterial concentrations on the bib clips, and thus to different possible cross-contamination risks. Future analyses will be performed to identify the bacterial species in samples from both pre- and post-disinfected clips, and to determine if they harbor disease-causing bacterial species that can pose a potential, yet undetermined risk for cross-contamination.

  6. Clinical Trial Risk in Hepatitis C: Endpoint Selection and Drug Action

    PubMed Central

    Tillie, Nicole A.; Parker, Jayson L.; Feld, Jordan J.

    2016-01-01

    Background and Aims. This study analyzed the risk of clinical trial failure of new drugs for hepatitis C between January 1998 and January 2015. Methods. Hepatitis C drug development trials that were in phases I–III of clinical trial testing were obtained from the publicly accessible clinical trial repository and other publicly available databases. Drug compounds were excluded from the study if they began their phase I testing before 1998, if they were not industry sponsored, or if they treated secondary complications of hepatitis C. Clinical trial success rates were analyzed in comparison to industry expectations. Further analysis was conducted on the molecule classifications, the mechanisms of action, and the trial endpoints. Results. One hundred and twenty-three unique drug compounds were found to fulfill the inclusion criteria, eight of which had FDA approval. The overall cumulative pass rate for hepatitis C drugs was 20%, which is double the industry expectation rate. Viral inhibitor small molecule drugs significantly reduced the risk of drug failure during clinical trials compared to other mechanisms of action. Conclusion. On average, one in every five drugs that began clinical testing will be approved for market. Viral inhibitor small molecule drugs are the most promising and hold the least risk. PMID:27446855

  7. Discrimination of GutCheckNEC, a clinical risk index for necrotizing enterocolitis

    PubMed Central

    Gephart, Sheila M.; Spitzer, Alan R.; Effken, Judith A.; Dodd, Elizabeth; Halpern, Melissa; McGrath, Jacqueline M.

    2014-01-01

    Background Better measures are needed to identify infants at risk for developing necrotizing enterocolitis (NEC) and facilitate communication about risk across transitions. Although NEC is multi-factorial, quantification of composite risk for NEC in an individual infant is not clearly defined. Objective This study’s objective was to describe the derivation, validation and calibration testing of a novel clinical NEC risk index, GutCheckNEC. Individual risk factors were weighted to assess composite odds of developing NEC. GutCheckNEC is designed to improve communication about NEC risk and coordination of care among clinicians across an infant’s clinical course. Methods Based on a synthesis of research evidence about NEC risk and an e-Delphi study including 35 neonatal experts, we identified NEC risk factors believed by the experts to be most relevant for a NEC risk index then applied a logistic model building process to derive and validate GutCheckNEC. De-identified data from the Pediatrix BabySteps Clinical Data Warehouse (discharge date 2007-2011) were split into three samples for derivation, validation and calibration. By comparing infants with medical NEC, surgical NEC, and those who died to infants without NEC, we derived the logistic model using the un-matched derivation set. Discrimination was then tested in a case-control matched validation set and an un-matched calibration set using ROC curves. Results Sampled from a cohort of 58 820 infants, the randomly selected derivation set (n= 35 013) revealed 9 independent risk factors (gestational age, history of packed red blood cell transfusion, unit NEC rate, late onset sepsis, multiple infections, hypotension treated with inotropic medications, Black or Hispanic race, outborn status, and metabolic acidosis) and 2 risk reducers (human milk feeding on both days 7 and 14 of life, and probiotics). Unit NEC rate carried the most weight in the summed score. Validation using a 2: 1 matched case-control sample (n=360

  8. Cow-specific risk factors for clinical mastitis in Brazilian dairy cattle.

    PubMed

    Oliveira, C S F; Hogeveen, H; Botelho, A M; Maia, P V; Coelho, S G; Haddad, J P A

    2015-10-01

    Information related to mastitis risk factors is useful for the design and implementation of clinical mastitis (CM) control programs. The first objective of our study was to model the risk of CM under Brazilian conditions, using cow-specific risk factors. Our second objective was to explore which risk factors were associated with the occurrence of the most common pathogens involved in Brazilian CM infections. The analyses were based on 65 months of data from 9,789 dairy cows and 12,464 CM cases. Cow-specific risk factors that could easily be measured in standard Brazilian dairy farms were used in the statistical analyses, which included logistic regression and multinomial logistic regression. The first month of lactation, high somatic cell count, rainy season and history of clinical mastitis cases were factors associated with CM for both primiparous and multiparous cows. In addition, parity and breed were also associated risk factors for multiparous cows. Of all CM cases, 54% showed positive bacteriological culturing results from which 57% were classified as environmental pathogens, with a large percentage of coliforms (35%). Coagulase-negative Staphylococcus (16%), Streptococcus uberis (9%), Streptococcus agalactiae (7%) and other Streptococci (9%) were also common pathogens. Among the pathogens analyzed, the association of cow-specific risk factors, such as Zebu breed (OR=5.84, 95%CI 3.77-10.77) and accumulated history of SCC (1.76, 95%CI 1.37-2.27), was different for CM caused by Coagulase-negative Staphylococcus and S. agalactiae in comparison to CM caused by coliforms. Our results suggest that CM control programs in Brazil should specially consider the recent history of clinical mastitis cases and the beginning of the lactations, mainly during the rainy season as important risk factor for mastitis.

  9. Cow-specific risk factors for clinical mastitis in Brazilian dairy cattle.

    PubMed

    Oliveira, C S F; Hogeveen, H; Botelho, A M; Maia, P V; Coelho, S G; Haddad, J P A

    2015-10-01

    Information related to mastitis risk factors is useful for the design and implementation of clinical mastitis (CM) control programs. The first objective of our study was to model the risk of CM under Brazilian conditions, using cow-specific risk factors. Our second objective was to explore which risk factors were associated with the occurrence of the most common pathogens involved in Brazilian CM infections. The analyses were based on 65 months of data from 9,789 dairy cows and 12,464 CM cases. Cow-specific risk factors that could easily be measured in standard Brazilian dairy farms were used in the statistical analyses, which included logistic regression and multinomial logistic regression. The first month of lactation, high somatic cell count, rainy season and history of clinical mastitis cases were factors associated with CM for both primiparous and multiparous cows. In addition, parity and breed were also associated risk factors for multiparous cows. Of all CM cases, 54% showed positive bacteriological culturing results from which 57% were classified as environmental pathogens, with a large percentage of coliforms (35%). Coagulase-negative Staphylococcus (16%), Streptococcus uberis (9%), Streptococcus agalactiae (7%) and other Streptococci (9%) were also common pathogens. Among the pathogens analyzed, the association of cow-specific risk factors, such as Zebu breed (OR=5.84, 95%CI 3.77-10.77) and accumulated history of SCC (1.76, 95%CI 1.37-2.27), was different for CM caused by Coagulase-negative Staphylococcus and S. agalactiae in comparison to CM caused by coliforms. Our results suggest that CM control programs in Brazil should specially consider the recent history of clinical mastitis cases and the beginning of the lactations, mainly during the rainy season as important risk factor for mastitis. PMID:26302854

  10. An Update on the Epidemiology of Schizophrenia with a Special Reference to Clinically Important Risk Factors

    ERIC Educational Resources Information Center

    El-Missiry, Ahmed; Aboraya, Ahmed Sayed; Manseur, Hader; Manchester, Johnna; France, Cheryl; Border, Katherine

    2011-01-01

    Schizophrenia is a chronic mental illness which poses a tremendous burden on the families, caregivers and the society. The purpose of this paper is to provide an updated review of the epidemiology of schizophrenia with a special attention to the clinically important risk factors such as drug abuse, hormonal factors and the new advances in genetic…

  11. Caries Risk Assessment for Determination of Focus and Intensity of Prevention in a Dental School Clinic.

    ERIC Educational Resources Information Center

    Dodds, Michael W. J.; Suddick, Richard P.

    1995-01-01

    A study at the University of Texas, San Antonio's dental school resulted in development of a system of caries risk assessment, applied to all undergraduate clinic patients. The rationale, structure, elements, and application of the system are outlined, and course content supporting the system is noted. Need for validation and other improvements is…

  12. Risk Factors for Clinically Significant Intimate Partner Violence among Active-Duty Members

    ERIC Educational Resources Information Center

    Smith Slep, Amy M.; Foran, Heather M.; Heyman, Richard E.; Snarr, Jeffery D.

    2011-01-01

    Hypothesized risk factors for men's and women's clinically significant intimate partner violence (CS-IPV) from four ecological levels (i.e., individual, family, workplace, community) were tested in a representative sample of active-duty U.S. Air Force members (N = 42,744). When considered together, we expected only individual and family factors to…

  13. Using local lexicalized rules to identify heart disease risk factors in clinical notes.

    PubMed

    Karystianis, George; Dehghan, Azad; Kovacevic, Aleksandar; Keane, John A; Nenadic, Goran

    2015-12-01

    Heart disease is the leading cause of death globally and a significant part of the human population lives with it. A number of risk factors have been recognized as contributing to the disease, including obesity, coronary artery disease (CAD), hypertension, hyperlipidemia, diabetes, smoking, and family history of premature CAD. This paper describes and evaluates a methodology to extract mentions of such risk factors from diabetic clinical notes, which was a task of the i2b2/UTHealth 2014 Challenge in Natural Language Processing for Clinical Data. The methodology is knowledge-driven and the system implements local lexicalized rules (based on syntactical patterns observed in notes) combined with manually constructed dictionaries that characterize the domain. A part of the task was also to detect the time interval in which the risk factors were present in a patient. The system was applied to an evaluation set of 514 unseen notes and achieved a micro-average F-score of 88% (with 86% precision and 90% recall). While the identification of CAD family history, medication and some of the related disease factors (e.g. hypertension, diabetes, hyperlipidemia) showed quite good results, the identification of CAD-specific indicators proved to be more challenging (F-score of 74%). Overall, the results are encouraging and suggested that automated text mining methods can be used to process clinical notes to identify risk factors and monitor progression of heart disease on a large-scale, providing necessary data for clinical and epidemiological studies.

  14. Attachment and At-Risk Infants: Theoretical Perspectives and Clinical Implications.

    ERIC Educational Resources Information Center

    Caulfield, Rick; Wallach, Vicki

    1998-01-01

    Reviews and discusses the basic dimensions of Bowlby's theory of infant attachment. Provides an overview of the basic definitions and propositions of his theory, in addition to the clinical applications of his theory to the field of early education and intervention with at-risk children and their families. (EV)

  15. High heart rate: more than a risk factor. Lessons from a clinical practice survey.

    PubMed

    Barrios, Vivencio; Escobar, Carlos; Bertomeu, Vicente; Murga, Nekane; de Pablo, Carmen; Asín, Enrique

    2009-11-12

    Several epidemiological studies have reported that an elevated heart rate (HR) is associated with coronary atherosclerosis independently of other risk factors. Nevertheless, it is still unclear whether HR is itself the cause or there is merely an association between HR and mortality in this population. A total of 1686 patients with hypertension and chronic ischemic heart disease were included in this study. According to the resting HR, the patients were distributed in 3 groups (group 1: HR<63 bpm; group 2: 63-82 bpm; group 3: >82 bpm). 580 patients (34.4%) belonged to group 1; 936 (55.5%) to group 2 and 170 (10.1%) to group 3. Patients with high HR exhibited a poorer prognosis not only due to a worse clinical profile (more concomitant cardiovascular risk factors and organ damage), but suggestively because despite the use of a similar number of drugs, patients with higher HR were associated with lesser risk control rates in daily clinical practice. Despite current guidelines that do not still recognize HR as a cardiovascular risk factor, it appears that physicians should pay more attention to it in clinical practice since high HR is warning about an increased risk.

  16. Effectiveness of a Pharmacist-Led Cardiovascular Risk Reduction Clinic in Rural Perry County, Alabama

    PubMed Central

    Sands, Charles; Ford, Frances

    2016-01-01

    Background. The Cardiovascular Risk Reduction Clinic (CRRC) in Perry County, Alabama, provides free pharmacist-led services. Clinic goals include improving health outcomes and reducing cardiovascular risk factors. Objective. To investigate the effectiveness of the CRRC in rural Perry County, Alabama. The reduction of the modifiable cardiovascular risk factors, blood pressure and body mass index, was evaluated to measure a decrease from baseline to last clinic date. Methods. This retrospective chart review identified 130 patients with at least two blood pressure and BMI measurements from baseline to June 30, 2010. The patients' paper files were used to collect baseline data and most recent measurements, which were recorded on a data collection sheet. Results. There was a statistically significant reduction in systolic blood pressure of 4.08 mmHg, 3.25 mmHg reduction in diastolic blood pressure, and 0.42 kg/m2 reduction in mean BMI. At their last visit prior to June 30, 2010, 59% of hypertensive patients and 35% of diabetic patients were meeting their blood pressure goals. Conclusion. Pharmacist-led management of patients with cardiovascular risk factors significantly reduced blood pressure and allowed more patients to meet their hypertension treatment goals. Despite being modest, reductions in blood pressure and BMI help reduce overall cardiovascular risks. PMID:27525302

  17. Carcinogenic risk assessment for emissions from clinical waste incineration and road traffic.

    PubMed

    Wheatley, Andrew; Sadhra, Steven

    2010-10-01

    The most significant potentially carcinogenic substances arising from a state-of-the-art clinical waste incinerator (CWI) and vehicle emissions were identified as polychlorinated dibenzo-p-dioxins, polycyclic aromatic hydrocarbons (PAHs), benzene, 1-butadiene, arsenic, cadmium, chromium and nickel. Long-term exposures of the notional maximum exposed individual (MEI) in the local environment, together with aggregate emissions from transport of clinical waste, were estimated. Mass emission rates of PAHs from the CWI to air were compared with previously published estimates of mass emissions to land from CWI bottom ash. Aggregate emissions from road transport of clinical waste were of a similar order to stack emissions from incineration. Mass emissions of PAHs to landfill generally greatly exceeded those from stack emissions. Emissions associated with operation of the CWI present a negligible contribution to overall cancer risk from PAHs and other carcinogens. Uncertainty in the quantitative risk estimates presented here is discussed in the context of these findings. PMID:20737342

  18. [OsteoLaus: prediction of osteoporotic fractures by clinical risk factors and DXA, IVA and TBS].

    PubMed

    Lamy, O; Metzger, M; Krieg, M-A; Aubry-Rozier, B; Stoll, D; Hans, D

    2011-11-01

    OsteoLaus is a cohort of 1400 women 50 to 80 years living in Lausanne, Switzerland. Clinical risk factors for osteoporosis, bone ultrasound of the heel, lumbar spine and hip bone mineral density (BMD), assessment of vertebral fracture by DXA, and microarchitecture evaluation by TBS (Trabecular Bone Score) will be recorded. TBS is a new parameter obtained after a re-analysis of a DXA exam. TBS is correlated with parameters of microarchitecture. His reproducibility is good. TBS give an added diagnostic value to BMD, and predict osteoporotic fracture (partially) independently to BMD. The position of TBS in clinical routine in complement to BMD and clinical risk factors will be evaluated in the OsteoLaus cohort.

  19. Chemotherapy and novel therapeutics before radical prostatectomy for high-risk clinically localized prostate cancer.

    PubMed

    Cha, Eugene K; Eastham, James A

    2015-05-01

    Although both surgery and radiation are potential curative options for men with clinically localized prostate cancer, a significant proportion of men with high-risk and locally advanced disease will demonstrate biochemical and potentially clinical progression of their disease. Neoadjuvant systemic therapy before radical prostatectomy (RP) is a logical strategy to improve treatment outcomes for men with clinically localized high-risk prostate cancer. Furthermore, delivery of chemotherapy and other systemic agents before RP affords an opportunity to explore the efficacy of these agents with pathologic end points. Neoadjuvant chemotherapy, primarily with docetaxel (with or without androgen deprivation therapy), has demonstrated feasibility and safety in men undergoing RP, but no study to date has established the efficacy of neoadjuvant chemotherapy or neoadjuvant chemohormonal therapies. Other novel agents, such as those targeting the vascular endothelial growth factor receptor, epidermal growth factor receptor, platelet-derived growth factor receptor, clusterin, and immunomodulatory therapeutics, are currently under investigation.

  20. Predictive capacity of risk assessment scales and clinical judgment for pressure ulcers: a meta-analysis.

    PubMed

    García-Fernández, Francisco Pedro; Pancorbo-Hidalgo, Pedro L; Agreda, J Javier Soldevilla

    2014-01-01

    A systematic review with meta-analysis was completed to determine the capacity of risk assessment scales and nurses' clinical judgment to predict pressure ulcer (PU) development. Electronic databases were searched for prospective studies on the validity and predictive capacity of PUs risk assessment scales published between 1962 and 2010 in English, Spanish, Portuguese, Korean, German, and Greek. We excluded gray literature sources, integrative review articles, and retrospective or cross-sectional studies. The methodological quality of the studies was assessed according to the guidelines of the Critical Appraisal Skills Program. Predictive capacity was measured as relative risk (RR) with 95% confidence intervals. When 2 or more valid original studies were found, a meta-analysis was conducted using a random-effect model and sensitivity analysis. We identified 57 studies, including 31 that included a validation study. We also retrieved 4 studies that tested clinical judgment as a risk prediction factor. Meta-analysis produced the following pooled predictive capacity indicators: Braden (RR = 4.26); Norton (RR = 3.69); Waterlow (RR = 2.66); Cubbin-Jackson (RR = 8.63); EMINA (RR = 6.17); Pressure Sore Predictor Scale (RR = 21.4); and clinical judgment (RR = 1.89). Pooled analysis of 11 studies found adequate risk prediction capacity in various clinical settings; the Braden, Norton, EMINA (mEntal state, Mobility, Incontinence, Nutrition, Activity), Waterlow, and Cubbin-Jackson scales showed the highest predictive capacity. The clinical judgment of nurses was found to achieve inadequate predictive capacity when used alone, and should be used in combination with a validated scale.

  1. Dyslipidemia and cardiovascular disease risk profiles of patients attending an HIV treatment clinic in Harare, Zimbabwe.

    PubMed

    Zhou, Danai Tavonga; Kodogo, Vitaris; Chokuona, Kudzai Fortunate Vongai; Gomo, Exnevia; Oektedalen, Olav; Stray-Pedersen, Babill

    2015-01-01

    The chronic inflammation induced by human immunodeficiency virus (HIV) contributes to increased risk of coronary heart disease (CHD) in HIV-infected individuals. HIV-infected patients generally benefit from being treated with antiretroviral drugs, but some antiretroviral agents have side effects, such as dyslipidemia and hyperglycemia. There is general consensus that antiretroviral drugs induce a long-term risk of CHD, although the levels of that risk are somewhat controversial. The intention of this cross-sectional study was to describe the lipid profile and the long-term risk of CHD among HIV-positive outpatients at an HIV treatment clinic in Harare, Zimbabwe. Two hundred and fifteen patients were investigated (females n=165, mean age 39.8 years; males n=50; mean age 42.0 years). Thirty of the individuals were antiretroviral-naïve and 185 had been on antiretroviral therapy (ART) for a mean 3.9±3.4 years. All participants had average lipid and glucose values within normal ranges, but there was a small difference between the ART and ART-for total cholesterol (TC) and high-density lipoprotein (HDL). Those on a combination of D4T or ZDV/NVP/3TC and PI-based ART were on average oldest and had the highest TC levels. Framingham risk showed 1.4% prevalence of high CHD risk within the next ten years. After univariate analysis age, sex, TC/HDL ratio, HDL, economic earnings and systolic BP were associated with medium to high risk of CHD. After multivariate regression analysis and adjusting for age or sex only age, sex and economic earnings were associated with medium to high risk of CHD. There is small risk of developing CHD, during the next decade in HIV infected patients at an HIV treatment clinic in Harare.

  2. Imaging Radiation Doses and Associated Risks and Benefits in Subjects Participating in Breast Cancer Clinical Trials

    PubMed Central

    Spera, Gonzalo; Meyer, Carlos; Cabral, Pablo; Mackey, John R.

    2015-01-01

    Background. Medical imaging is commonly required in breast cancer (BC) clinical trials to assess the efficacy and/or safety of study interventions. Despite the lack of definitive epidemiological data linking imaging radiation with cancer development in adults, concerns exist about the risks of imaging radiation-induced malignancies (IRIMs) in subjects exposed to repetitive imaging. We estimated the imaging radiation dose and IRIM risk in subjects participating in BC trials. Materials and Methods. The imaging protocol requirements in 10 phase III trials in the adjuvant and advanced settings were assessed to estimate the effective radiation dose received by a typical and fully compliant subject in each trial. For each study, the excess lifetime attributable cancer risk (LAR) was calculated using the National Cancer Institute’s Radiation Risk Assessment Tool, version 3.7.1. Dose and risk calculations were performed for both imaging intensive and nonintensive approaches to reflect the variability in imaging performed within the studies. Results. The total effective imaging radiation dose was 0.4–262.2 mSv in adjuvant trials and 26–241.3 mSv in metastatic studies. The dose variability resulted from differing protocol requirements and imaging intensity approaches, with computed tomography, multigated acquisition scans, and bone scans as the major contributors. The mean LAR was 1.87–2,410/100,000 in adjuvant trials (IRIM: 0.0002%–2.41% of randomized subjects) and 6.9–67.3/100,000 in metastatic studies (IRIM: 0.007%–0.067% of subjects). Conclusion. IRIMs are infrequent events. In adjuvant trials, aligning the protocol requirements with the clinical guidelines’ surveillance recommendations and substituting radiating procedures with equivalent nonradiating ones would reduce IRIM risk. No significant risk has been observed in metastatic trials, and potential concerns on IRIMs are not justified. Implications for Practice: Medical imaging is key in breast cancer

  3. CAIDE Dementia Risk Score and biomarkers of neurodegeneration in memory clinic patients without dementia.

    PubMed

    Enache, Daniela; Solomon, Alina; Cavallin, Lena; Kåreholt, Ingemar; Kramberger, Milica Gregoric; Aarsland, Dag; Kivipelto, Miia; Eriksdotter, Maria; Winblad, Bengt; Jelic, Vesna

    2016-06-01

    The aim of this study was to explore cross-sectional associations between Cardiovascular Risk Factors, Aging and Dementia Study (CAIDE) Dementia Risk Score and dementia-related cerebrospinal fluid and neuroimaging biomarkers in 724 patients without dementia from the Memory Clinic at Karolinska University Hospital, Huddinge, Sweden. We additionally evaluated the score's capacity to predict dementia. Two risk score versions were calculated: one including age, gender, obesity, hyperlipidemia, and hypertension; and one additionally including apolipoprotein E (APOE) ε4 carrier status. Cerebrospinal fluid was analyzed for amyloid β (Aβ), total tau, and phosphorylated tau. Visual assessments of medial temporal lobe atrophy (MTA), global cortical atrophy-frontal subscale, and Fazekas scale for white matter changes (WMC) were performed. Higher CAIDE Dementia Risk Score (version without APOE) was significantly associated with higher total tau, more severe MTA, WMC, and global cortical atrophy-frontal subscale. Higher CAIDE Dementia Risk Score (version with APOE) was associated with reduced Aβ, more severe MTA, and WMC. CAIDE Dementia Risk Score version with APOE seemed to predict dementia better in this memory clinic population with short follow-up than the version without APOE. PMID:27143429

  4. Hereditary and environmental risk factors; clinical and laboratory risk matters for head and neck, especially oral, cancer and precancer.

    PubMed

    Johnson, N W; Warnakulasuriy, S; Tavassoli, M

    1996-02-01

    The continuing high incidence and mortality of squamous cell carcinoma of the upper aerodigestive tract in South Asia, parts of France and central Europe, together with a rising incidence and mortality from a lower base elsewhere in the Western world, stimulates continuing research on risk factors and risk markers. Tobaccos (smoked and smokeless), heavy alcohol consumption, and areca nut remain the dominant risk factors, with confirmation of the protective effects of diets rich in antioxidants. There is emerging evidence of a small, but real, risk associated with occupational and other air pollution, and with family, part of which may be hereditary. Markers in peripheral blood and saliva are underexploited. Clinical staging and histological grading methods continue to be refined, with improved prognostic value, much aided by newer and simpler methods for estimating cell proliferation and apoptosis. Data on the significance of viral genes are still inadequate, but there is good progress describing the epidemiology of chromosomal abnormalities and abberations of a growing list of oncogenes and tumour suppressor genes. Unfortunately, as yet, these have only limited longitudinal or prognostic data.

  5. Usability Testing and Adaptation of the Pediatric Cardiovascular Risk Reduction Clinical Decision Support Tool

    PubMed Central

    Furberg, Robert D; Bagwell, Jacqueline E; LaBresh, Kenneth A

    2016-01-01

    Background Cardiovascular disease (CVD) is 1 of the leading causes of death, years of life lost, and disability-adjusted years of life lost worldwide. CVD prevention for children and teens is needed, as CVD risk factors and behaviors beginning in youth contribute to CVD development. In 2012, the National Heart, Lung, and Blood Institute released their “Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents” for clinicians, describing CVD risk factors they should address with patients at primary care preventative visits. However, uptake of new guidelines is slow. Clinical decision support (CDS) tools can improve guideline uptake. In this paper, we describe our process of testing and adapting a CDS tool to help clinicians evaluate patient risk, recommend behaviors to prevent development of risk, and complete complex calculations to determine appropriate interventions as recommended by the guidelines, using a user-centered design approach. Objective The objective of the study was to assess the usability of a pediatric CVD risk factor tool by clinicians. Methods The tool was tested using one-on-one in-person testing and a “think aloud” approach with 5 clinicians and by using the tool in clinical practice along with formal usability metrics with 14 pediatricians. Thematic analysis of the data from the in-person testing and clinical practice testing identified suggestions for change in 3 major areas: user experience, content refinement, and technical deployment. Descriptive statistical techniques were employed to summarize users’ overall experience with the tool. Results Data from testers showed that general reactions toward the CDS tool were positive. Clinical practice testers suggested revisions to make the application more user-friendly, especially for clinicians using the application on the iPhone, and called for refining recommendations to be more succinct and better tailored to the patient. Tester feedback was

  6. A new proposal for benefit-less-risk analysis in clinical trials.

    PubMed

    Chuang-Stein, C

    1994-02-01

    In this paper, we propose a method to discount the observed benefit of a treatment by the observed risk in order to facilitate the benefit-less-risk comparison of treatments in a clinical trial. The discounting, applied to each individual in a trial, utilizes a method proposed by Chuang-Stein and co-authors to consolidate the safety data collected in the trial. The collating of the safety information allows one to estimate quantitatively the risk experienced by each individual, and therefore enables the construction of a risk-adjusted benefit measure for the same individual. We discuss the rationale for the adjusting method and examine its impact on the inference. When the discounting process reflects an individual's choice, the results should be interpreted at the individual level. An example is given to illustrate the approach. PMID:7908619

  7. Translation of the Risk Avoidance Partnership (RAP) for Implementation in Outpatient Drug Treatment Clinics.

    PubMed

    Weeks, Margaret R; Kostick, Kristin; Li, Jianghong; Dunn, Jennifer; McLaughlin, Paul; Richmond, Phil; Choudhury, Shonali; Obidoa, Chinekwu; Mosher, Heather; Martinez, Maria

    2015-01-01

    Scientific literature increasingly calls for studies to translate evidence-based interventions into real-world contexts balancing fidelity to the original design and fit to the new setting. The Risk Avoidance Partnership (RAP) is a health promotion intervention originally designed to train active drug users to become Peer Health Advocates. A theoretically driven approach was used to adapt RAP to fit implementation in outpatient methadone treatment clinics and pilot it with clinic patients. Ethnographic observations and process tracking documented the RAP translation and pilot experience, and clinic and community characteristics relevant to program implementation. Clinic administrators, staff, and patients were interviewed on their values, capacities, interest in RAP, perceived challenges of implementing RAP in drug treatment clinics, and experiences during the pilot. Findings indicated that RAP core components can be met when implemented in these settings and RAP can fit with the goals, interests, and other programs of the clinic. Balancing fidelity and fit requires recognition of the mutual impacts RAP and the clinic have on each other, which generate new interactions among staff and require ongoing specification of RAP to keep abreast of clinic and community changes. Collaboration of multiple stakeholders significantly benefited translation and pilot processes.

  8. An Unusual BRCA Mutation Distribution in a High Risk Cancer Genetics Clinic

    PubMed Central

    Nelson-Moseke, Anna C.; Jeter, Joanne M.; Cui, Haiyan; Roe, Denise J.; Chambers, Setsuko K.; Laukaitis, Christina M.

    2012-01-01

    The Database of Individuals at High Risk for Breast, Ovarian, or Other Hereditary Cancers at the Arizona Cancer Center in Tucson, Arizona, assesses cancer risk factors and outcomes in patients with a family history of cancer or a known genetic mutation. We analyzed the subset of clinic probands who carry deleterious BRCA gene mutations to identify factors that could explain why mutations in BRCA2 out number those in BRCA1. Medical, family, social, ethnic and genetic mutation histories were collected from consenting patients’ electronic medical records. Differences between BRCA1 and BRCA2 probands from this database were analyzed for statistical significance and compared to published analyses.. A significantly higher proportion of our clinic probands carry mutations in BRCA2 than BRCA1, compared with previous reports of mutation prevalence. This also holds true for the Hispanic sub-group. Probands with BRCA2 mutations were significantly more likely than their BRCA1 counterparts to present to the high risk clinic without adiagnosis of cancer. Other differences between the groups were not significant. Six previously unreported BRCA2 mutations appear in our clinic population. The increased proportion of probands carrying deleterious BRCA2 mutations is likely multifactorial, but may reflect aspects of Southern Arizona’s unique ethnic heritage. PMID:23179792

  9. The Prioritization of Clinical Risk Factors of Obstructive Sleep Apnea Severity Using Fuzzy Analytic Hierarchy Process

    PubMed Central

    Maranate, Thaya; Pongpullponsak, Adisak; Ruttanaumpawan, Pimon

    2015-01-01

    Recently, there has been a problem of shortage of sleep laboratories that can accommodate the patients in a timely manner. Delayed diagnosis and treatment may lead to worse outcomes particularly in patients with severe obstructive sleep apnea (OSA). For this reason, the prioritization in polysomnography (PSG) queueing should be endorsed based on disease severity. To date, there have been conflicting data whether clinical information can predict OSA severity. The 1,042 suspected OSA patients underwent diagnostic PSG study at Siriraj Sleep Center during 2010-2011. A total of 113 variables were obtained from sleep questionnaires and anthropometric measurements. The 19 groups of clinical risk factors consisting of 42 variables were categorized into each OSA severity. This study aimed to array these factors by employing Fuzzy Analytic Hierarchy Process approach based on normalized weight vector. The results revealed that the first rank of clinical risk factors in Severe, Moderate, Mild, and No OSA was nighttime symptoms. The overall sensitivity/specificity of the approach to these groups was 92.32%/91.76%, 89.52%/88.18%, 91.08%/84.58%, and 96.49%/81.23%, respectively. We propose that the urgent PSG appointment should include clinical risk factors of Severe OSA group. In addition, the screening for Mild from No OSA patients in sleep center setting using symptoms during sleep is also recommended (sensitivity = 87.12% and specificity = 72.22%). PMID:26221183

  10. Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation

    PubMed Central

    Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A.; Arima, Hisatomi; Wang, Dao Wen

    2016-01-01

    Abstract Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin–angiotensin–aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin–angiotensin–aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive. A pooled study of 6 randomized controlled trials assessing the efficacy of renin–angiotensin–aldosterone blockers on subjects with atrial fibrillation was performed. A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76– 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70–0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2–2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0–6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0–0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: –0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction. This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation. PMID:27368043

  11. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Safeguards for Children in Clinical Investigations § 50.53 Clinical investigations involving greater than... in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an... involve children as subjects only if the IRB finds and documents that: (a) The risk represents a...

  12. Body Mass Index, Self-Esteem, and Suicide Risk in Clinically Depressed African American and White American Females.

    ERIC Educational Resources Information Center

    Palmer, Charles James, Jr.

    2003-01-01

    Assessed whether clinically depressed healthy-weight, overweight, and obese females would differ on self-esteem and suicide risk measures. Data on clinically depressed females from an inpatient psychiatric unit indicated that the three groups did not differ significantly on measures of self-esteem and suicide risk, but depressed, obese, white…

  13. Self-awareness of functional impairment in individuals at clinical high-risk for psychosis

    PubMed Central

    Olvet, Doreen M.; Carrión, Ricardo E.; Auther, Andrea M.; Cornblatt, Barbara A.

    2013-01-01

    Aims A major public health concern associated with schizophrenia is the long-term disability that involves an inability to function independently in the community. An individual’s self-awareness of functional impairment may be a significant factor contributing to long-term disability. In fact, subjective interpretation of one’s illness impacts treatment participation and adherence, and is linked to poor outcomes. However, it remains unclear how illness-related functional impairment is perceived by individuals prior to the onset of psychosis. This study aims to examine the relationship between clinician-based and self-report assessments of functioning, as well as the contribution of clinical symptoms to this relationship in individuals at clinical high-risk for psychosis. Methods The Sheehan Disability Scale, a self-rated instrument, was used to measure disruption in daily functioning in social and role functioning due to symptoms in a sample of 73 treatment-seeking patients at clinical high-risk for psychosis and 50 healthy controls. Results Relative to healthy controls, clinical high-risk patients self-reported significant disruptions in social and role functioning. In addition, a specific relationship emerged in that clinician-rated measures of functioning and depression were related to disability scores. Conclusions These findings suggest that clinical high-risk patients are significantly disturbed by their illness. Self-reported disruption of daily functioning was associated with clinician-rated functioning and depressive symptoms, further highlighting the impact of functional impairments on the level of distress experienced by patients in the early phases of the illness. Intervention strategies that repair functional impairment before the onset of psychosis may prevent long-term disability. PMID:23968457

  14. Integration of genetic and clinical risk factors improves prognostication in relapsed childhood B-cell precursor acute lymphoblastic leukemia

    PubMed Central

    Irving, Julie A. E.; Enshaei, Amir; Parker, Catriona A.; Sutton, Rosemary; Kuiper, Roland P.; Erhorn, Amy; Minto, Lynne; Venn, Nicola C.; Law, Tamara; Yu, Jiangyan; Schwab, Claire; Davies, Rosanna; Matheson, Elizabeth; Davies, Alysia; Sonneveld, Edwin; den Boer, Monique L.; Love, Sharon B.; Harrison, Christine J.; Hoogerbrugge, Peter M.; Revesz, Tamas; Saha, Vaskar

    2016-01-01

    Somatic genetic abnormalities are initiators and drivers of disease and have proven clinical utility at initial diagnosis. However, the genetic landscape and its clinical utility at relapse are less well understood and have not been studied comprehensively. We analyzed cytogenetic data from 427 children with relapsed B-cell precursor ALL treated on the international trial, ALLR3. Also we screened 238 patients with a marrow relapse for selected copy number alterations (CNAs) and mutations. Cytogenetic risk groups were predictive of outcome postrelapse and survival rates at 5 years for patients with good, intermediate-, and high-risk cytogenetics were 68%, 47%, and 26%, respectively (P < .001). TP53 alterations and NR3C1/BTG1 deletions were associated with a higher risk of progression: hazard ratio 2.36 (95% confidence interval, 1.51-3.70, P < .001) and 2.15 (1.32-3.48, P = .002). NRAS mutations were associated with an increased risk of progression among standard-risk patients with high hyperdiploidy: 3.17 (1.15-8.71, P = .026). Patients classified clinically as standard and high risk had distinct genetic profiles. The outcome of clinical standard-risk patients with high-risk cytogenetics was equivalent to clinical high-risk patients. Screening patients at relapse for key genetic abnormalities will enable the integration of genetic and clinical risk factors to improve patient stratification and outcome. This study is registered at www.clinicaltrials.org as #ISCRTN45724312. PMID:27229005

  15. Integration of genetic and clinical risk factors improves prognostication in relapsed childhood B-cell precursor acute lymphoblastic leukemia.

    PubMed

    Irving, Julie A E; Enshaei, Amir; Parker, Catriona A; Sutton, Rosemary; Kuiper, Roland P; Erhorn, Amy; Minto, Lynne; Venn, Nicola C; Law, Tamara; Yu, Jiangyan; Schwab, Claire; Davies, Rosanna; Matheson, Elizabeth; Davies, Alysia; Sonneveld, Edwin; den Boer, Monique L; Love, Sharon B; Harrison, Christine J; Hoogerbrugge, Peter M; Revesz, Tamas; Saha, Vaskar; Moorman, Anthony V

    2016-08-18

    Somatic genetic abnormalities are initiators and drivers of disease and have proven clinical utility at initial diagnosis. However, the genetic landscape and its clinical utility at relapse are less well understood and have not been studied comprehensively. We analyzed cytogenetic data from 427 children with relapsed B-cell precursor ALL treated on the international trial, ALLR3. Also we screened 238 patients with a marrow relapse for selected copy number alterations (CNAs) and mutations. Cytogenetic risk groups were predictive of outcome postrelapse and survival rates at 5 years for patients with good, intermediate-, and high-risk cytogenetics were 68%, 47%, and 26%, respectively (P < .001). TP53 alterations and NR3C1/BTG1 deletions were associated with a higher risk of progression: hazard ratio 2.36 (95% confidence interval, 1.51-3.70, P < .001) and 2.15 (1.32-3.48, P = .002). NRAS mutations were associated with an increased risk of progression among standard-risk patients with high hyperdiploidy: 3.17 (1.15-8.71, P = .026). Patients classified clinically as standard and high risk had distinct genetic profiles. The outcome of clinical standard-risk patients with high-risk cytogenetics was equivalent to clinical high-risk patients. Screening patients at relapse for key genetic abnormalities will enable the integration of genetic and clinical risk factors to improve patient stratification and outcome. This study is registered at www.clinicaltrials.org as #ISCRTN45724312. PMID:27229005

  16. Biopsychosocial influence on shoulder pain: risk subgroups translated across preclinical and clinical prospective cohorts.

    PubMed

    George, Steven Z; Wallace, Margaret R; Wu, Samuel S; Moser, Michael W; Wright, Thomas W; Farmer, Kevin W; Borsa, Paul A; Parr, Jeffrey J; Greenfield, Warren H; Dai, Yunfeng; Li, Hua; Fillingim, Roger B

    2015-01-01

    Tailored treatment based on individual risk factors is an area with promise to improve options for pain relief. Musculoskeletal pain has a biopsychosocial nature, and multiple factors should be considered when determining risk for chronic pain. This study investigated whether subgroups comprised genetic and psychological factors predicted outcomes in preclinical and clinical models of shoulder pain. Classification and regression tree analysis was performed for an exercise-induced shoulder injury cohort (n = 190) to identify high-risk subgroups, and a surgical pain cohort (n = 150) was used for risk validation. Questionnaires for fear of pain and pain catastrophizing were administered before injury and preoperatively. DNA collected from saliva was genotyped for a priori selected genes involved with pain modulation (COMT and AVPR1A) and inflammation (IL1B and TNF/LTA). Recovery was operationalized as a brief pain inventory rating of 0/10 for current pain intensity and <2/10 for worst pain intensity. Follow-up for the preclinical cohort was in daily increments, whereas follow-up for the clinical cohort was at 3, 6, and 12 months postoperatively. Risk subgroups comprised the COMT high pain sensitivity variant and either pain catastrophizing or fear of pain were predictive of heightened shoulder pain responses in the preclinical model. Further analysis in the clinical model identified the COMT high pain sensitivity variant and pain catastrophizing subgroup as the better predictor. Future studies will determine whether these findings can be replicated in other anatomical regions and whether personalized medicine strategies can be developed for this risk subgroup. PMID:25599310

  17. Classifying risk status of non-clinical adolescents using psychometric indicators for psychosis spectrum disorders.

    PubMed

    Fonseca-Pedrero, Eduardo; Gooding, Diane C; Ortuño-Sierra, Javier; Pflum, Madeline; Paino, Mercedes; Muñiz, José

    2016-09-30

    This study is an attempt to evaluate extant psychometric indicators using latent profile analysis for classifying community-derived individuals based on a set of clinical, behavioural, and personality traits considered risk markers for psychosis spectrum disorders. The present investigation included four hundred and forty-nine high-school students between the ages of 12 and 19. We used the following to assess risk: the Prodromal Questionnaire-Brief (PQ-B), Oviedo Schizotypy Assessment Questionnaire (ESQUIZO-Q), Anticipatory and Consummatory Interpersonal Pleasure Scale-Adolescent version (ACIPS-A), and General Health Questionnaire 12 (GHQ-12). Using Latent profile analysis six latent classes (LC) were identified: participants in class 1 (LC1) displayed little or no symptoms and accounted for 38.53% of the sample; class 2 (LC2), who accounted for 28.06%, also produced low mean scores across most measures though they expressed somewhat higher levels of subjective distress; LC3, a positive schizotypy group (10.24%); LC4 (13.36%), a psychosis high-risk group; LC5, a high positive and negative schizotypy group (4.45%); and LC6, a very high distress, severe clinical high-risk group, comprised 5.34% of the sample. The current research indicates that different latent classes of early individuals at risk can be empirically defined in adolescent community samples using psychometric indicators for psychosis spectrum disorders. These findings may have implications for early detection and prevention strategies in psychosis spectrum disorders. PMID:27423122

  18. Improving Personalized Clinical Risk Prediction Based on Causality-Based Association Rules

    PubMed Central

    Cheng, Chih-wen; Wang, May D.

    2016-01-01

    Developing clinical risk prediction models is one of the main tasks of healthcare data mining. Advanced data collection techniques in current Big Data era have created an emerging and urgent need for scalable, computer-based data mining methods. These methods can turn data into useful, personalized decision support knowledge in a flexible, cost-effective, and productive way. In our previous study, we developed a tool, called icuARM- II, that can generate personalized clinical risk prediction evidence using a temporal rule mining framework. However, the generation of final risk prediction possibility with icuARM-II still relied on human interpretation, which was subjective and, most of time, biased. In this study, we propose a new mechanism to improve icuARM-II’s rule selection by including the concept of causal analysis. The generated risk prediction is quantitatively assessed using calibration statistics. To evaluate the performance of the new rule selection mechanism, we conducted a case study to predict short-term intensive care unit mortality based on personalized lab testing abnormalities. Our results demonstrated a better-calibrated ICU risk prediction using the new causality-base rule selection solution by comparing with conventional confidence-only rule selection methods. PMID:27532063

  19. A clinical and microbiologic analysis of risk factors for puerperal endometritis.

    PubMed

    Newton, E R; Prihoda, T J; Gibbs, R S

    1990-03-01

    Predictors of postpartum endometritis were identified in 607 asymptomatic, laboring women. One hundred (16.5%) developed postpartum endometritis. Multivariate analysis using stepwise logistic regression identified cesarean delivery (relative risk 12.8; P less than .0001) as the dominant overall predictor. In patients with cesarean delivery (N = 124), prophylactic antibiotics (relative risk 0.54; P less than .0002) and high-virulence bacteria or Mycoplasma hominis (relative risk 1.4; P less than .01) predicted the incidence of endometritis, and in patients with vaginal delivery (N = 483), "bacterial vaginosis organisms" (relative risk 14.2; P less than .001) and aerobic gram-negative rods (relative risk 4.2; P less than .01) predicted endometritis. Despite significant associations found on univariate analysis, clinical variables such as duration of labor, rupture of membranes, and internal monitoring were not predictive of endometritis in the multivariate analysis. Our findings show that cesarean delivery and certain organisms, such as bacterial vaginosis or high-virulence organisms, predict endometritis, and that clinical variables may be facilitators rather than predictors of endometritis. PMID:2406660

  20. Using base rates and correlational data to supplement clinical risk assessments.

    PubMed

    Davis, Jaya; Sorensen, Jon R

    2013-01-01

    The current study is a partial replication of previous studies designed to estimate the level of risk posed by capital murder defendants. The study draws on data describing the behavior of nearly 2,000 incarcerated capital murderers to forecast violence propensity among defendants sentenced to life imprisonment. Logistic regression is used to model various violence outcomes, relying on the following predictors: age, educational attainment, prior imprisonment, and gang affiliation. This exercise is designed to illustrate how actuarial data may be used to anchor individualized clinical assessments of risk in capital murder trials.

  1. Using base rates and correlational data to supplement clinical risk assessments.

    PubMed

    Davis, Jaya; Sorensen, Jon R

    2013-01-01

    The current study is a partial replication of previous studies designed to estimate the level of risk posed by capital murder defendants. The study draws on data describing the behavior of nearly 2,000 incarcerated capital murderers to forecast violence propensity among defendants sentenced to life imprisonment. Logistic regression is used to model various violence outcomes, relying on the following predictors: age, educational attainment, prior imprisonment, and gang affiliation. This exercise is designed to illustrate how actuarial data may be used to anchor individualized clinical assessments of risk in capital murder trials. PMID:24051592

  2. Clinically observed chickenpox and the risk of childhood-onset multiple sclerosis.

    PubMed

    Mikaeloff, Yann; Caridade, Guillaume; Suissa, Samy; Tardieu, Marc

    2009-05-15

    The authors conducted a population-based case-control study to investigate whether clinically observed chickenpox, linked with a level of intensity for clinical expression, increases the risk of multiple sclerosis (MS) in childhood. The cases were MS patients whose disease onset occurred between 1994 and 2003, before age 16 years, in France. Each case was matched for age, sex, and geographic origin with as many as 12 controls randomly selected from the general population. Information about clinically observed chickenpox in cases and controls before the index date regarding onset of MS was collected with a standardized questionnaire and was checked against health certificates. Conditional logistic regression was used to estimate the odds ratio for an association between MS and chickenpox. The 137 MS cases were matched with 1,061 controls. Clinically observed chickenpox had occurred in 76.6% of the cases and 84.9% of their matched controls. The adjusted odds ratio of MS onset associated with chickenpox occurrence was 0.58 (95% confidence interval: 0.36, 0.92). The authors concluded that clinically observed chickenpox was associated with a lower risk of childhood-onset MS in a French population.

  3. Clinical features of venous insufficiency and the risk of venous thrombosis in older people.

    PubMed

    Engbers, Marissa J; Karasu, Alev; Blom, Jeanet W; Cushman, Mary; Rosendaal, Frits R; van Hylckama Vlieg, Astrid

    2015-11-01

    Venous thrombosis is common in older age, with an incidence of 0·5-1% per year in those aged >70 years. Stasis of blood flow is an important contributor to the development of thrombosis and may be due to venous insufficiency in the legs. The risk of thrombosis associated with clinical features of venous insufficiency, i.e., varicose veins, leg ulcers and leg oedema, obtained with a standardized interview was assessed in the Age and Thrombosis Acquired and Genetic risk factors in the Elderly (AT-AGE) study. The AT-AGE study is a case-control study in individuals aged 70 years and older (401 cases with a first-time venous thrombosis and 431 control subjects). We calculated odds ratios (ORs) and corresponding 95% confidence intervals (CI) adjusted for age, sex and study centre. Varicose veins and leg ulcer were associated with a 1·6-fold (95% CI 1·2-2·3) and 3·3-fold increased risk of thrombosis (95% CI 1·6-6·7), respectively, while the risk was increased 3·0-fold (95% CI 2·1-4·5) in the presence of leg oedema. The risk of thrombosis was highest when all three risk factors occurred simultaneously (OR: 10·5; 95% CI 1·3-86·1). In conclusion, clinical features of venous insufficiency, i.e., varicose veins, leg ulcers and leg oedema, are risk factors for venous thrombosis in older people.

  4. Improving Clinical Risk Stratification at Diagnosis in Primary Prostate Cancer: A Prognostic Modelling Study

    PubMed Central

    Wright, Karen A.; Muir, Kenneth R.; Gavin, Anna

    2016-01-01

    Introduction Over 80% of the nearly 1 million men diagnosed with prostate cancer annually worldwide present with localised or locally advanced non-metastatic disease. Risk stratification is the cornerstone for clinical decision making and treatment selection for these men. The most widely applied stratification systems use presenting prostate-specific antigen (PSA) concentration, biopsy Gleason grade, and clinical stage to classify patients as low, intermediate, or high risk. There is, however, significant heterogeneity in outcomes within these standard groupings. The International Society of Urological Pathology (ISUP) has recently adopted a prognosis-based pathological classification that has yet to be included within a risk stratification system. Here we developed and tested a new stratification system based on the number of individual risk factors and incorporating the new ISUP prognostic score. Methods and Findings Diagnostic clinicopathological data from 10,139 men with non-metastatic prostate cancer were available for this study from the Public Health England National Cancer Registration Service Eastern Office. This cohort was divided into a training set (n = 6,026; 1,557 total deaths, with 462 from prostate cancer) and a testing set (n = 4,113; 1,053 total deaths, with 327 from prostate cancer). The median follow-up was 6.9 y, and the primary outcome measure was prostate-cancer-specific mortality (PCSM). An external validation cohort (n = 1,706) was also used. Patients were first categorised as low, intermediate, or high risk using the current three-stratum stratification system endorsed by the National Institute for Health and Care Excellence (NICE) guidelines. The variables used to define the groups (PSA concentration, Gleason grading, and clinical stage) were then used to sub-stratify within each risk category by testing the individual and then combined number of risk factors. In addition, we incorporated the new ISUP prognostic score as a discriminator

  5. Improving Clinical Risk Stratification at Diagnosis in Primary Prostate Cancer: A Prognostic Modelling Study

    PubMed Central

    Wright, Karen A.; Muir, Kenneth R.; Gavin, Anna

    2016-01-01

    Introduction Over 80% of the nearly 1 million men diagnosed with prostate cancer annually worldwide present with localised or locally advanced non-metastatic disease. Risk stratification is the cornerstone for clinical decision making and treatment selection for these men. The most widely applied stratification systems use presenting prostate-specific antigen (PSA) concentration, biopsy Gleason grade, and clinical stage to classify patients as low, intermediate, or high risk. There is, however, significant heterogeneity in outcomes within these standard groupings. The International Society of Urological Pathology (ISUP) has recently adopted a prognosis-based pathological classification that has yet to be included within a risk stratification system. Here we developed and tested a new stratification system based on the number of individual risk factors and incorporating the new ISUP prognostic score. Methods and Findings Diagnostic clinicopathological data from 10,139 men with non-metastatic prostate cancer were available for this study from the Public Health England National Cancer Registration Service Eastern Office. This cohort was divided into a training set (n = 6,026; 1,557 total deaths, with 462 from prostate cancer) and a testing set (n = 4,113; 1,053 total deaths, with 327 from prostate cancer). The median follow-up was 6.9 y, and the primary outcome measure was prostate-cancer-specific mortality (PCSM). An external validation cohort (n = 1,706) was also used. Patients were first categorised as low, intermediate, or high risk using the current three-stratum stratification system endorsed by the National Institute for Health and Care Excellence (NICE) guidelines. The variables used to define the groups (PSA concentration, Gleason grading, and clinical stage) were then used to sub-stratify within each risk category by testing the individual and then combined number of risk factors. In addition, we incorporated the new ISUP prognostic score as a discriminator

  6. Environmental risk assessment of clinical trials involving modified vaccinia virus Ankara (MVA)-based vectors.

    PubMed

    Goossens, Martine; Pauwels, Katia; Willemarck, Nicolas; Breyer, Didier

    2013-12-01

    The modified vaccinia virus Ankara (MVA) strain, which has been developed as a vaccine against smallpox, is since the nineties widely tested in clinical trials as recombinant vector for vaccination or gene therapy applications. Although MVA is renowned for its safety, several biosafety aspects need to be considered when performing the risk assessment of a recombinant MVA (rMVA). This paper presents the biosafety issues and the main lessons learned from the evaluation of the clinical trials with rMVA performed in Belgium. Factors such as the specific characteristics of the rMVA, the inserted foreign sequences/transgene, its ability for reconversion, recombination and dissemination in the population and the environment are the main points of attention. Measures to prevent or manage identified risks are also discussed.

  7. Rocky milieu: challenges of effective integration of clinical risk management into hospitals in Iran.

    PubMed

    Farokhzadian, Jamileh; Nayeri, Nahid Dehghan; Borhani, Fariba

    2015-01-01

    Healthcare risks and clinical risks have been recognized as a major challenge in healthcare. Clinical risks can never be eliminated and can have serious adverse effects on patient safety. Thus, a clinical risk management (CRM) system has been introduced in the healthcare system to improve quality services. The aim of this study was to explore nurses' experiences related to the challenges of implementing CRM in the organizational context. This qualitative study was based on the conventional content analysis of the Lundman and Graneheim approach, and it consisted of 22 interview sessions with 20 nurses. The purposive sampling method was used to choose the participants from three hospitals affiliated with the Kerman University of Medical Sciences. We used semi-structured interviews and review of relevant documents to collect data. The analysis of the data led to the emergence of "rocky milieu" as the main theme, and it consisted of three categories that, along with their subcategories, explain the challenges of implementing CRM. The three categories and their subcategories were (1) organizational culture and leadership challenges (decision and performance of leadership and cultural resistance to change), (2) limitation of resources (financial, human, and physical and equipment resources), and (3) variations and complexities in working conditions (the emotional, psychological, and social atmosphere and the heaviness of workload). Attempts have been made to establish CRM through clinical governance and accreditation, but organizational challenges have created a rocky milieu for implementing CRM. However, from an organizational context concerning the suitability of healthcare in Iran, there are obvious needs to move toward quality improvement and safe practices through the effective implementation of CRM. PMID:25968444

  8. Rocky milieu: Challenges of effective integration of clinical risk management into hospitals in Iran

    PubMed Central

    Farokhzadian, Jamileh; Nayeri, Nahid Dehghan; Borhani, Fariba

    2015-01-01

    Healthcare risks and clinical risks have been recognized as a major challenge in healthcare. Clinical risks can never be eliminated and can have serious adverse effects on patient safety. Thus, a clinical risk management (CRM) system has been introduced in the healthcare system to improve quality services. The aim of this study was to explore nurses’ experiences related to the challenges of implementing CRM in the organizational context. This qualitative study was based on the conventional content analysis of the Lundman and Graneheim approach, and it consisted of 22 interview sessions with 20 nurses. The purposive sampling method was used to choose the participants from three hospitals affiliated with the Kerman University of Medical Sciences. We used semi-structured interviews and review of relevant documents to collect data. The analysis of the data led to the emergence of “rocky milieu” as the main theme, and it consisted of three categories that, along with their subcategories, explain the challenges of implementing CRM. The three categories and their subcategories were (1) organizational culture and leadership challenges (decision and performance of leadership and cultural resistance to change), (2) limitation of resources (financial, human, and physical and equipment resources), and (3) variations and complexities in working conditions (the emotional, psychological, and social atmosphere and the heaviness of workload). Attempts have been made to establish CRM through clinical governance and accreditation, but organizational challenges have created a rocky milieu for implementing CRM. However, from an organizational context concerning the suitability of healthcare in Iran, there are obvious needs to move toward quality improvement and safe practices through the effective implementation of CRM. PMID:25968444

  9. Coverage of clinic-based TB screening in South Africa may be low in key risk groups.

    PubMed

    McCreesh, N; Faghmous, I; Looker, C; Dodd, P J; Plumb, I D; Shanaube, K; Muyoyeta, M; Godfrey-Faussett, P; Ayles, H; White, R G

    2016-03-21

    The South African Ministry of Health has proposed screening all clinic attendees for tuberculosis (TB). Amongst other factors, male sex and bar attendance are associated with higher TB risk. We show that 45% of adults surveyed in Western Cape attended a clinic within 6 months, and therefore potentially a relatively high proportion of the population could be reached through clinic-based screening. However, fewer than 20% of all men aged 18-25 years, or men aged 26-45 who attend bars, attended a clinic. The population-level impact of clinic-based screening may be reduced by low coverage among key risk groups.

  10. Quantitative ultrasound criteria for risk stratification in clinical practice: a comparative assessment.

    PubMed

    Noale, Marianna; Maggi, Stefania; Gonnelli, Stefano; Limongi, Federica; Zanoni, Silvia; Zambon, Sabina; Rozzini, Renzo; Crepaldi, Gaetano

    2012-07-01

    This study aimed to compare two different classifications of the risk of fracture/osteoporosis (OP) based on quantitative ultrasound (QUS). Analyses were based on data from the Epidemiological Study on the Prevalence of Osteoporosis, a cross-sectional study conducted in 2000 aimed at assessing the risk of OP in a representative sample of the Italian population. Subjects were classified into 5 groups considering the cross-classification found in previous studies; logistic regression models were defined separately for women and men to study the fracture risk attributable to groups defined by the cross-classification, adjusting for traditional risk factors. Eight-thousand six-hundred eighty-one subjects were considered in the analyses. Logistic regression models revealed that the two classifications seem to be able to identify a common core of individuals at low and at high risk of fractures, and the importance of a multidimensional assessment in older patients to evaluate clinical risk factors together with a simple, inexpensive, radiation-free device such as QUS.

  11. Lifetime Increased Cancer Risk in Mice Following Exposure to Clinical Proton Beam–Generated Neutrons

    SciTech Connect

    Gerweck, Leo E. Huang, Peigen; Lu, Hsiao-Ming; Paganetti, Harald; Zhou, Yenong

    2014-05-01

    Purpose: To evaluate the life span and risk of cancer following whole-body exposure of mice to neutrons generated by a passively scattered clinical spread-out Bragg peak (SOBP) proton beam. Methods and Materials: Three hundred young adult female FVB/N mice, 152 test and 148 control, were entered into the experiment. Mice were placed in an annular cassette around a cylindrical phantom, which was positioned lateral to the mid-SOBP of a 165-MeV, clinical proton beam. The average distance from the edge of the mid-SOBP to the conscious active mice was 21.5 cm. The phantom was irradiated with once-daily fractions of 25 Gy, 4 days per week, for 6 weeks. The age at death and cause of death (ie, cancer and type vs noncancer causes) were assessed over the life span of the mice. Results: Exposure of mice to a dose of 600 Gy of proton beam–generated neutrons, reduced the median life span of the mice by 4.2% (Kaplan-Meier cumulative survival, P=.053). The relative risk of death from cancer in neutron exposed versus control mice was 1.40 for cancer of all types (P=.0006) and 1.22 for solid cancers (P=.09). For a typical 60 Gy dose of clinical protons, the observed 22% increased risk of solid cancer would be expected to decrease by a factor of 10. Conclusions: Exposure of mice to neutrons generated by a proton dose that exceeds a typical course of radiation therapy by a factor of 10, resulted in a statistically significant increase in the background incidence of leukemia and a marginally significant increase in solid cancer. The results indicate that the risk of out-of-field second solid cancers from SOBP proton-generated neutrons and typical treatment schedules, is 6 to 10 times less than is suggested by current neutron risk estimates.

  12. Lifetime increased cancer risk in mice following exposure to clinical proton beam generated neutrons

    PubMed Central

    Gerweck, Leo E.; Huang, Peigen; Lu, Hsiao-Ming; Paganetti, Harald; Zhou, Yenong

    2014-01-01

    Purpose To evaluate the lifespan and risk of cancer following whole-body exposure of mice to neutrons generated by a passively scattered clinical SOBP proton beam. Methods and Materials Three hundred young adult female FVB/N mice, 152 test and 148 control, were entered into the experiment. Mice were placed in an annular cassette around a cylindrical phantom, which was positioned lateral to the mid SOBP of a 165 MeV, clinical proton beam. The average distance from the edge of the mid SOBP to the conscious active mice was 21.5 cm. The phantom was irradiated with once daily fractions of 25 Gy, 4 days per week, for 6 weeks. The age at death and cause of death, i.e., cancer and type vs. non-cancer causes, were assessed over the lifespan of the mice. Results Exposure of mice to a dose of 600 Gy of proton beam generated neutrons, reduced the median lifespan of the mice by 4.2% (Kaplan-Meier cumulative survival, P = 0.053). The relative risk of death from cancer in neutron exposed vs. control mice was 1.40 for cancer of all types (P = 0.0006) and 1.22 for solid cancers (P = 0.09). For a typical 60 Gy dose of clinical protons, the observed 22% increased risk of solid cancer would be expected to decrease by a factor of 10. Conclusions Exposure of mice to neutrons generated by a proton dose which exceeds a typical course of radiotherapy by a factor of 10, resulted in a statistically significant increase in the background incidence of leukemia and a marginally significant increase in solid cancer. The results indicate that the risk of out-of-field 2nd solid cancers from SOBP proton generated neutrons and typical treatment schedules, is 6 - 10 times less than is suggested by current neutron risk estimates. PMID:24725699

  13. Prefrontal Function at Presentation Directly Related to Clinical Outcome in People at Ultrahigh Risk of Psychosis

    PubMed Central

    Fusar-Poli, P.; Broome, M.R.; Matthiasson, P.; Woolley, J.B.; Mechelli, A.; Johns, L.C.; Tabraham, P.; Bramon, E.; Valmaggia, L.; Williams, S.C.; McGuire, P.

    2011-01-01

    Background: The prodromal phase of psychosis is characterized by impaired executive function and altered prefrontal activation. The extent to which the severity of these deficits at presentation predicts subsequent clinical outcomes is unclear. Methods: We employed functional magnetic resonance imaging in a cohort of subjects at clinical risk for psychosis and in healthy controls. Images were acquired at clinical presentation and again after 1 year, using a 1.5-T Signa MRI scanner while subjects were performing a verbal fluency task. SPM5 was used for the analysis of imaging data. Psychopathological assessment of the “at-risk” symptoms was performed by using the Comprehensive Assessment for the At-Risk Mental State (CAARMS) and the Positive and Negative Symptom Scale (PANSS). Results: In the at-risk mental state (ARMS) group, between presentation and follow-up, the CAARMS (perceptual disorder and thought disorder subscales) and the PANSS general scores decreased, while the Global Assessment of Functioning (GAF) score increased. Both the ARMS and control groups performed the verbal fluency task with a high degree of accuracy. The ARMS group showed greater activation in the left inferior frontal gyrus but less activation in the anterior cingulate gyrus than controls. Within the ARMS group, the longitudinal normalization of neurofunctional response in the left inferior frontal gyrus was positively correlated with the improvement in severity of hallucination-like experiences. Conclusions: The normalization of the abnormal prefrontal response during executive functioning is associated with 12-month psychopathological improvement of prodromal symptoms. PMID:19666832

  14. Acanthamoeba, fungal, and bacterial keratitis: a comparison of risk factors and clinical features

    PubMed Central

    Mascarenhas, Jeena; Lalitha, Prajna; Prajna, N. Venkatesh; Srinivasan, Muthiah; Das, Manoranjan; D’Silva, Sean S.; Oldenburg, Catherine E.; Borkar, Durga S.; Esterberg, Elizabeth J.; Lietman, Thomas M.; Keenan, Jeremy D.

    2013-01-01

    Purpose To determine risk factors and clinical signs that may differentiate between bacterial, fungal, and acanthamoeba keratitis among patients presenting with presumed infectious keratitis. Design Hospital-based cross-sectional study. Methods We examined the medical records of 115 patients with laboratory-proven bacterial keratitis, 115 patients with laboratory-proven fungal keratitis, and 115 patients with laboratory-proven acanthamoeba keratitis seen at Aravind Eye Hospital, Madurai, India, from 2006–2011. Risk factors and clinical features of the three organisms were compared using multinomial logistic regression. Results Of 95 patients with bacterial keratitis, 103 patients with fungal keratitis, and 93 patients with acanthamoeba keratitis who had medical records available for review, 287 (99%) did not wear contact lenses. Differentiating features were more common for acanthamoeba keratitis than for bacterial or fungal keratitis. Compared to patients with bacterial or fungal keratitis, patients with acanthamoeba keratitis were more likely to be younger and to have a longer duration of symptoms, and to have a ring infiltrate or disease confined to the epithelium. Conclusions Risk factors and clinical examination findings can be useful for differentiating acanthamoeba keratitis from bacterial and fungal keratitis. PMID:24200232

  15. Hepatitis B Vaccine Antibody Response and the Risk of Clinical AIDS or Death

    PubMed Central

    Landrum, Michael L.; Hullsiek, Katherine Huppler; O'Connell, Robert J.; Chun, Helen M.; Ganesan, Anuradha; Okulicz, Jason F.; Lalani, Tahaniyat; Weintrob, Amy C.; Crum-Cianflone, Nancy F.; Agan, Brian K.

    2012-01-01

    Background Whether seroresponse to a vaccine such as hepatitis B virus (HBV) vaccine can provide a measure of the functional immune status of HIV-infected persons is unknown.This study evaluated the relationship between HBV vaccine seroresponses and progression to clinical AIDS or death. Methods and Findings From a large HIV cohort, we evaluated those who received HBV vaccine only after HIV diagnosis and had anti-HBs determination 1–12 months after the last vaccine dose. Non-response and positive response were defined as anti-HBs <10 and ≥10 IU/L, respectively. Participants were followed from date of last vaccination to clinical AIDS, death, or last visit. Univariate and multivariable risk of progression to clinical AIDS or death were evaluated with Cox regression models. A total of 795 participants vaccinated from 1986–2010 were included, of which 41% were responders. During 3,872 person-years of observation, 122 AIDS or death events occurred (53% after 1995). Twenty-two percent of non-responders experienced clinical AIDS or death compared with 5% of responders (p<0.001). Non-response to HBV vaccine was associated with a greater than 2-fold increased risk of clinical AIDS or death (HR 2.47; 95% CI, 1.38–4.43) compared with a positive response, after adjusting for CD4 count, HIV viral load, HAART use, and delayed type hypersensitivity skin test responses (an in vivo marker of cell-mediated immunity). This association remained evident among those with CD4 count ≥500 cells/mm3 (HR 3.40; 95% CI, 1.39–8.32). Conclusions HBV vaccine responses may have utility in assessing functional immune status and risk stratificating HIV-infected individuals, including those with CD4 count ≥500 cells/mm3. PMID:22457767

  16. Profiles of Risk Among HIV-infected Youth in Clinic Settings

    PubMed Central

    Huszti, Heather C.; Wilson, Patrick A.; Kahana, Shoshana; Nichols, Sharon; Gonin, René; Xu, Jiahong; Kapogiannis, Bill G.

    2014-01-01

    Despite the rising number of new HIV infections among youth, few tailored interventions for youth living with HIV (YLH) have been developed and rigorously tested. Developing tailored interventions necessitates identifying different profiles of YLH and understanding how risk and protective factors cluster together. Obtaining this critical information requires accessing a sufficiently large sample of YLH from diverse geographic settings such as those available through the Adolescent Trials Network for HIV Interventions (ATN). We recruited a cross-sectional sample of 1,712 YLH from ATN clinics; participants completed a survey on psychosocial and health factors. Using latent class analysis on nine composite variables representing risk factors, we identified five classes distinguished by substance use, sexual behavior, and pregnancy history and differing on health outcomes. Findings suggest a need for tailored interventions addressing multiple risky behaviors of HIV-infected youth and research to clarify how intervention effectiveness may differ by risk profile. PMID:25117556

  17. Associating Changes in the Immune System with Clinical Diseases for Interpretation in Risk Assessment.

    PubMed

    DeWitt, Jamie C; Germolec, Dori R; Luebke, Robert W; Johnson, Victor J

    2016-01-01

    This overview is an update of the unit originally published in 2004. While the basic tenets of immunotoxicity have not changed in the past 10 years, several publications have explored the application of immunotoxicological data to the risk assessment process. Therefore, the goal of this unit is still to highlight relationships between xenobiotic-induced immunosuppression and risk of clinical diseases progression. In immunotoxicology, this may require development of models to equate moderate changes in markers of immune functions to potential changes in incidence or severity of infectious diseases. For most xenobiotics, exposure levels and disease incidence data are rarely available, and safe exposure levels must be estimated based on observations from experimental models or human biomarker studies. Thus, it is important to establish a scientifically sound framework that allows accurate and quantitative interpretation of experimental or biomarker data in the risk assessment process.

  18. Cardiovascular risk factor analysis in patients with a recent clinical fracture at the fracture liaison service.

    PubMed

    Wyers, Caroline E; Vranken, Lisanne; van der Velde, Robert Y; Geusens, Piet P M M; Janzing, Heinrich M J; Morrenhof, J Wim; van den Bergh, Joop P W

    2014-01-01

    Patients with a low bone mineral density have an increased risk of cardiovascular diseases (CVD) and venous thromboembolic events (VTE). The aim of our retrospective chart review was to investigate the prevalence of CVD, VTE, hypertension (HT), and diabetes mellitus type 2 (DM2) in patients with a recent clinical fracture visiting the Fracture Liaison Service (FLS). Out of 3057 patients aged 50-90 years, 1359 consecutive patients, who agreed and were able to visit the FLS for fracture risk evaluation, were included (71.7% women; mean age 65.2 yrs). Based on medical history, 29.9% had a history of CVD (13.7%), VTE (1.7%), HT (14.9%), and DM2 (7.1%) or a combination. Their prevalence increased with age (21% in patients aged 50-59 years to 48% in patients aged >80 years) and was higher in men than in women (36% versus 27%), but independent of bone mineral density and fracture type. Careful evaluation of medical history with respect to these risk factors should be performed in patients with a recent clinical fracture before starting treatment with medications that increase the risk of VTE or cardiovascular events, such as raloxifene, strontium ranelate, or NSAIDs. PMID:25247184

  19. Dipeptidyl peptidase-4 inhibitors and fracture risk: an updated meta-analysis of randomized clinical trials.

    PubMed

    Fu, Jianying; Zhu, Jianhong; Hao, Yehua; Guo, Chongchong; Zhou, Zhikun

    2016-01-01

    Data on the effects of dipeptidyl peptidase-4 (DPP-4) inhibitors on fracture risk are conflicting. Here, we performed a systematic review and meta-analysis of randomized controlled trials (RCTs) assessing the effects of DPP-4 inhibitors. Electronic databases were searched for relevant published articles, and unpublished studies presented at ClinicalTrials.gov were searched for relevant clinical data. Eligible studies included prospective randomized trials evaluating DPP-4 inhibitors versus placebo or other anti-diabetic medications in patients with type 2 diabetes. Study quality was determined using Jadad scores. Statistical analyses were performed to calculate the risk ratios (RRs) and 95% confidence intervals (CIs) using fixed-effects models. There were 62 eligible RCTs with 62,206 participants, including 33,452 patients treated with DPP-4 inhibitors. The number of fractures was 364 in the exposed group and 358 in the control group. The overall risk of fracture did not differ between patients exposed to DPP-4 inhibitors and controls (RR, 0.95; 95% CI, 0.83-1.10; P = 0.50). The results were consistent across subgroups defined by type of DPP-4 inhibitor, type of control, and length of follow-up. The study showed that DPP-4 inhibitor use does not modify the risk of bone fracture compared with placebo or other anti-diabetic medications in patients with type 2 diabetes. PMID:27384445

  20. Dipeptidyl peptidase-4 inhibitors and fracture risk: an updated meta-analysis of randomized clinical trials

    PubMed Central

    Fu, Jianying; Zhu, Jianhong; Hao, Yehua; Guo, Chongchong; Zhou, Zhikun

    2016-01-01

    Data on the effects of dipeptidyl peptidase-4 (DPP-4) inhibitors on fracture risk are conflicting. Here, we performed a systematic review and meta-analysis of randomized controlled trials (RCTs) assessing the effects of DPP-4 inhibitors. Electronic databases were searched for relevant published articles, and unpublished studies presented at ClinicalTrials.gov were searched for relevant clinical data. Eligible studies included prospective randomized trials evaluating DPP-4 inhibitors versus placebo or other anti-diabetic medications in patients with type 2 diabetes. Study quality was determined using Jadad scores. Statistical analyses were performed to calculate the risk ratios (RRs) and 95% confidence intervals (CIs) using fixed-effects models. There were 62 eligible RCTs with 62,206 participants, including 33,452 patients treated with DPP-4 inhibitors. The number of fractures was 364 in the exposed group and 358 in the control group. The overall risk of fracture did not differ between patients exposed to DPP-4 inhibitors and controls (RR, 0.95; 95% CI, 0.83–1.10; P = 0.50). The results were consistent across subgroups defined by type of DPP-4 inhibitor, type of control, and length of follow-up. The study showed that DPP-4 inhibitor use does not modify the risk of bone fracture compared with placebo or other anti-diabetic medications in patients with type 2 diabetes. PMID:27384445

  1. Risks to the fetus from diagnostic imaging during pregnancy: review and proposal of a clinical protocol.

    PubMed

    Gomes, Mafalda; Matias, Alexandra; Macedo, Filipe

    2015-12-01

    Every day, medical practitioners face the dilemma of exposing pregnant or possibly pregnant patients to radiation from diagnostic examinations. Both doctors and patients often have questions about the risks of radiation. The most vulnerable period is between the 8th and 15th weeks of gestation. Deterministic effects like pregnancy loss, congenital malformations, growth retardation and neurobehavioral abnormalities have threshold doses above 100-200 mGy. The risk is considered negligible at 50 mGy and in reality no diagnostic examination exceeds this limit. The risk of carcinogenesis is slightly higher than in the general population. Intravenous iodinated contrast is discouraged, except in highly selected patients. Considering all the possible noxious effects of radiation exposure, measures to diminish radiation are essential and affect the fetal outcome. Nonionizing procedures should be considered whenever possible and every radiology center should have its own data analysis on fetal radiation exposure. In this review, we analyze existing literature on fetal risks due to radiation exposure, producing a clinical protocol to guide safe radiation use in a clinical setting.

  2. DNA Methylation-Guided Prediction of Clinical Failure in High-Risk Prostate Cancer

    PubMed Central

    Joniau, Steven; Lerut, Evelyne; Laenen, Annouschka; Gevaert, Thomas; Gevaert, Olivier; Spahn, Martin; Kneitz, Burkhard; Gramme, Pierre; Helleputte, Thibault; Isebaert, Sofie; Haustermans, Karin; Bollen, Mathieu

    2015-01-01

    Background Prostate cancer (PCa) is a very heterogeneous disease with respect to clinical outcome. This study explored differential DNA methylation in a priori selected genes to diagnose PCa and predict clinical failure (CF) in high-risk patients. Methods A quantitative multiplex, methylation-specific PCR assay was developed to assess promoter methylation of the APC, CCND2, GSTP1, PTGS2 and RARB genes in formalin-fixed, paraffin-embedded tissue samples from 42 patients with benign prostatic hyperplasia and radical prostatectomy specimens of patients with high-risk PCa, encompassing training and validation cohorts of 147 and 71 patients, respectively. Log-rank tests, univariate and multivariate Cox models were used to investigate the prognostic value of the DNA methylation. Results Hypermethylation of APC, CCND2, GSTP1, PTGS2 and RARB was highly cancer-specific. However, only GSTP1 methylation was significantly associated with CF in both independent high-risk PCa cohorts. Importantly, trichotomization into low, moderate and high GSTP1 methylation level subgroups was highly predictive for CF. Patients with either a low or high GSTP1 methylation level, as compared to the moderate methylation groups, were at a higher risk for CF in both the training (Hazard ratio [HR], 3.65; 95% CI, 1.65 to 8.07) and validation sets (HR, 4.27; 95% CI, 1.03 to 17.72) as well as in the combined cohort (HR, 2.74; 95% CI, 1.42 to 5.27) in multivariate analysis. Conclusions Classification of primary high-risk tumors into three subtypes based on DNA methylation can be combined with clinico-pathological parameters for a more informative risk-stratification of these PCa patients. PMID:26086362

  3. Weighing the evidence: risks and benefits of participatory documentary in corporatized clinics.

    PubMed

    Hansen, Helena

    2013-12-01

    This paper describes the effects of one U.S.-based public psychiatry clinic's shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on "evidence based" treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends. PMID:23932854

  4. Weighing the evidence: risks and benefits of participatory documentary in corporatized clinics.

    PubMed

    Hansen, Helena

    2013-12-01

    This paper describes the effects of one U.S.-based public psychiatry clinic's shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on "evidence based" treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends.

  5. Clinical risk factors associated with anti-epileptic drug responsiveness in canine epilepsy.

    PubMed

    Packer, Rowena M A; Shihab, Nadia K; Torres, Bruno B J; Volk, Holger A

    2014-01-01

    The nature and occurrence of remission, and conversely, pharmacoresistance following epilepsy treatment is still not fully understood in human or veterinary medicine. As such, predicting which patients will have good or poor treatment outcomes is imprecise, impeding patient management. In the present study, we use a naturally occurring animal model of pharmacoresistant epilepsy to investigate clinical risk factors associated with treatment outcome. Dogs with idiopathic epilepsy, for which no underlying cause was identified, were treated at a canine epilepsy clinic and monitored following discharge from a small animal referral hospital. Clinical data was gained via standardised owner questionnaires and longitudinal follow up data was gained via telephone interview with the dogs' owners. At follow up, 14% of treated dogs were in seizure-free remission. Dogs that did not achieve remission were more likely to be male, and to have previously experienced cluster seizures. Seizure frequency or the total number of seizures prior to treatment were not significant predictors of pharmacoresistance, demonstrating that seizure density, that is, the temporal pattern of seizure activity, is a more influential predictor of pharmacoresistance. These results are in line with clinical studies of human epilepsy, and experimental rodent models of epilepsy, that patients experiencing episodes of high seizure density (cluster seizures), not just a high seizure frequency pre-treatment, are at an increased risk of drug-refractoriness. These data provide further evidence that the dog could be a useful naturally occurring epilepsy model in the study of pharmacoresistant epilepsy.

  6. Clinical characteristics of drug-induced liver injury and related risk factors

    PubMed Central

    Lu, Ren-Jie; Zhang, Yan; Tang, Feng-Lei; Zheng, Zhong-Wei; Fan, Zheng-Da; Zhu, Shan-Mei; Qian, Xian-Feng; Liu, Na-Na

    2016-01-01

    Drug-induced liver injury (DILI) is often undiagnosed or misdiagnosed clinically because of diagnostic difficulties caused by lack of laboratory-specific serological markers. In this study, we comprehensively assessed the clinical characteristics, laboratory indices, hepatotoxic drugs, risk factors and outcomes concerning DILI, and explored the similarities in mechanisms between Chinese and Western drug-induced DILI. Patients with a first diagnosis of DILI and a Roussel Uclaf Causality Assessment Method (RUCAM) score >3 points were enrolled for systematic retrospective study. Their clinical characteristics, clinical classification, risk factors, laboratory indices, hepatotoxic drugs and outcomes were analyzed. Cholestatic patients had the highest alkaline phosphatase (ALP) and prothrombin time activity (PTA) levels (P<0.05). Patients with medication time ≥30 days had significantly higher positive rate of autoantibodies than those with medication time <30 days. Odds ratio values for DILI-related factors such as hepatobiliary diseases, immune dysfunction, diabetes, hypertension, chronic alcohol consumption and age ≥45 years were 6.552, 6.130, 3.774, 2.801, 2.002 and 1.838, respectively. Pathogeneses of Chinese and Western drug-induced DILI may be substantially the same. DILI accompanied with autoantibody positivity may indicate severe liver injury outcome. Hepatobiliary diseases, diabetes and hypertension are likely to increase drug susceptibility, and more prone to cause liver injury. PMID:27703513

  7. fMRI investigation of response inhibition, emotion, impulsivity, and clinical high-risk behavior in adolescents

    PubMed Central

    Brown, Matthew R. G.; Benoit, James R. A.; Juhás, Michal; Dametto, Ericson; Tse, Tiffanie T.; MacKay, Marnie; Sen, Bhaskar; Carroll, Alan M.; Hodlevskyy, Oleksandr; Silverstone, Peter H.; Dolcos, Florin; Dursun, Serdar M.; Greenshaw, Andrew J.

    2015-01-01

    High-risk behavior in adolescents is associated with injury, mental health problems, and poor outcomes in later life. Improved understanding of the neurobiology of high-risk behavior and impulsivity shows promise for informing clinical treatment and prevention as well as policy to better address high-risk behavior. We recruited 21 adolescents (age 14–17) with a wide range of high-risk behavior tendencies, including medically high-risk participants recruited from psychiatric clinics. Risk tendencies were assessed using the Adolescent Risk Behavior Screen (ARBS). ARBS risk scores correlated highly (0.78) with impulsivity scores from the Barratt Impulsivity scale (BIS). Participants underwent 4.7 Tesla functional magnetic resonance imaging (fMRI) while performing an emotional Go/NoGo task. This task presented an aversive or neutral distractor image simultaneously with each Go or NoGo stimulus. Risk behavior and impulsivity tendencies exhibited similar but not identical associations with fMRI activation patterns in prefrontal brain regions. We interpret these results as reflecting differences in response inhibition, emotional stimulus processing, and emotion regulation in relation to participant risk behavior tendencies and impulsivity levels. The results are consistent with high impulsivity playing an important role in determining high risk tendencies in this sample containing clinically high-risk adolescents. PMID:26483645

  8. Practical Problems With Clinical Guidelines for Breast Cancer Prevention Based on Remaining Lifetime Risk

    PubMed Central

    Quante, Anne S.; Whittemore, Alice S.; Shriver, Tom; Hopper, John L.; Strauch, Konstantin

    2015-01-01

    Background: Clinical guidelines for breast cancer chemoprevention and MRI screening involve estimates of remaining lifetime risk (RLR); in the United States, women with an RLR of 20% or higher meet “high-risk” criteria for MRI screening. Methods: We prospectively followed 1764 women without breast cancer to compare the RLRs and 10-year risks assigned by the risk models International Breast Cancer Intervention Study (IBIS) and Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm (BOADICEA) and to compare both sets of model-assigned 10-year risks to subsequent incidence of breast cancer in the cohort. We used chi-square statistics to assess calibration and the area under the receiver operating characteristic curve (AUC) to assess discrimination. All statistical tests are two-sided. Results: The models classified different proportions of women as high-risk (IBIS = 59.3% vs BOADICEA = 20.1%) using the RLR threshold of 20%. The difference was smaller (IBIS = 52.9% vs BOADICEA = 43.2%) using a 10-year risk threshold of 3.34%. IBIS risks (mean = 4.9%) were better calibrated to observed breast cancer incidence (5.2%, 95% confidence interval (CI) = 4.2% to 6.4%) than were those of BOADICEA (mean = 3.7%) overall and within quartiles of model risk (P = .20 by IBIS and P = .07 by BOADICEA). Both models gave similar discrimination, with AUCs of 0.67 (95% CI = 0.61 to 0.73) using IBIS and 0.68 (95% CI = 0.62 to 0.74) using BOADICEA. Model sensitivities at thresholds for a 20% false-positive rate were also similar, with 41.8% using IBIS and 38.0% using BOADICEA. Conclusion: RLR-based guidelines for high-risk women are limited by discordance between commonly used risk models. Guidelines based on short-term risks would be more useful, as models are generally developed and validated under a short fixed time horizon (≤10 years). PMID:25956172

  9. Clinical and Biological Risk Factors for Neuropsychological Impairment in Alcohol Use Disorder

    PubMed Central

    Ritz, Ludivine; Coulbault, Laurent; Lannuzel, Coralie; Boudehent, Céline; Segobin, Shailendra; Eustache, Francis; Vabret, François; Pitel, Anne Lise; Beaunieux, Hélène

    2016-01-01

    The effects of alcoholism on cognitive and motor functioning are heterogeneous. While the role of some factors (patterns of alcohol consumption, eating habits or associated liver disease) has been hypothesized, the origins of this heterogeneity remain difficult to establish. The goals of the present study were thus to identify the clinical and biological risk factors for alcohol-related neuropsychological impairments and to determine the threshold beyond which these risk factors can be considered significant. Thirty alcoholic patients and 15 healthy controls had a blood test and underwent a neuropsychological examination. Alcohol severity measures, and liver, thiamine and malnutrition variables, were included in logistic regression models to determine the risk factors for cognitive and motor impairments (executive functions, visuospatial abilities, verbal episodic memory, ataxia), as well as those related to the severity of patients’ overall neuropsychological profile (moderate or severe impairments). Liver fibrosis was found to be a risk factor for executive impairments and also for ataxia, when it was associated with long-term alcohol misuse and symptoms of withdrawal. Altered thiamine metabolism was solely predictive of verbal episodic memory impairments. This combination of biological abnormalities was associated with a profile of moderate neuropsychological impairments. Malnutrition was associated with a profile of more severe impairments. Malnutrition, altered liver function and thiamine metabolism explain, at least partially, the heterogeneity of alcohol-related neuropsychological impairments. Our findings could allow clinicians to identify patients at particular risk of severe neuropsychological impairments before the onset of irreversible and debilitating neurological complications. PMID:27617840

  10. Can we improve clinical prediction of at-risk older drivers?

    PubMed Central

    Bowers, Alex R.; Anastasio, R. Julius; Sheldon, Sarah S.; O’Connor, Margaret G.; Hollis, Ann M.; Howe, Piers D.; Horowitz, Todd S.

    2013-01-01

    Objectives To conduct a pilot study to evaluate the predictive value of the Montreal Cognitive Assessment test (MoCA) and a brief test of multiple object tracking (MOT) relative to other tests of cognition and attention in identifying at-risk older drivers, and to determine which combination of tests provided the best overall prediction. Methods Forty-seven currently-licensed drivers (58 to 95 years), primarily from a clinical driving evaluation program, participated. Their performance was measured on: (1) a screening test battery, comprising MoCA, MOT, MiniMental State Examination (MMSE), Trail-Making Test, visual acuity, contrast sensitivity, and Useful Field of View (UFOV); and (2) a standardized road test. Results Eighteen participants were rated at-risk on the road test. UFOV subtest 2 was the best single predictor with an area under the curve (AUC) of .84. Neither MoCA nor MOT was a better predictor of the at-risk outcome than either MMSE or UFOV, respectively. The best four-test combination (MMSE, UFOV subtest 2, visual acuity and contrast sensitivity) was able to identify at-risk drivers with 95% specificity and 80% sensitivity (.91 AUC). Conclusions Although the best four-test combination was much better than a single test in identifying at-risk drivers, there is still much work to do in this field to establish test batteries that have both high sensitivity and specificity. PMID:23954688

  11. Clinical and Biological Risk Factors for Neuropsychological Impairment in Alcohol Use Disorder.

    PubMed

    Ritz, Ludivine; Coulbault, Laurent; Lannuzel, Coralie; Boudehent, Céline; Segobin, Shailendra; Eustache, Francis; Vabret, François; Pitel, Anne Lise; Beaunieux, Hélène

    2016-01-01

    The effects of alcoholism on cognitive and motor functioning are heterogeneous. While the role of some factors (patterns of alcohol consumption, eating habits or associated liver disease) has been hypothesized, the origins of this heterogeneity remain difficult to establish. The goals of the present study were thus to identify the clinical and biological risk factors for alcohol-related neuropsychological impairments and to determine the threshold beyond which these risk factors can be considered significant. Thirty alcoholic patients and 15 healthy controls had a blood test and underwent a neuropsychological examination. Alcohol severity measures, and liver, thiamine and malnutrition variables, were included in logistic regression models to determine the risk factors for cognitive and motor impairments (executive functions, visuospatial abilities, verbal episodic memory, ataxia), as well as those related to the severity of patients' overall neuropsychological profile (moderate or severe impairments). Liver fibrosis was found to be a risk factor for executive impairments and also for ataxia, when it was associated with long-term alcohol misuse and symptoms of withdrawal. Altered thiamine metabolism was solely predictive of verbal episodic memory impairments. This combination of biological abnormalities was associated with a profile of moderate neuropsychological impairments. Malnutrition was associated with a profile of more severe impairments. Malnutrition, altered liver function and thiamine metabolism explain, at least partially, the heterogeneity of alcohol-related neuropsychological impairments. Our findings could allow clinicians to identify patients at particular risk of severe neuropsychological impairments before the onset of irreversible and debilitating neurological complications. PMID:27617840

  12. [Systemic error analysis as a key element of clinical risk management].

    PubMed

    Bartz, Hans-Jürgen

    2015-01-01

    Systemic error analysis plays a key role in clinical risk management. This includes all clinical and administrative activities which identify, assess and reduce the risks of damage to patients and to the organization. The clinical risk management is an integral part of quality management. This is also the policy of the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) on the fundamental requirements of an internal quality management. The goal of all activities is to improve the quality of medical treatment and patient safety. Primarily this is done by a systemic analysis of incidents and errors. A results-oriented systemic error analysis needs an open and unprejudiced corporate culture. Errors have to be transparent and measures to improve processes have to be taken. Disciplinary action on staff must not be part of the process. If these targets are met, errors and incidents can be analyzed and the process can create added value to the organization. There are some proven instruments to achieve that. This paper discusses in detail the error and risk analysis (ERA), which is frequently used in German healthcare organizations. The ERA goes far beyond the detection of problems due to faulty procedures. It focuses on the analysis of the following contributory factors: patient factors, task and process factors, individual factors, team factors, occupational and environmental factors, psychological factors, organizational and management factors and institutional context. Organizations can only learn from mistakes by analyzing these factors systemically and developing appropriate corrective actions. This article describes the fundamentals and implementation of the method at the University Medical Center Hamburg-Eppendorf.

  13. Clinical Risk Factors for In-Hospital Adverse Cardiovascular Events After Acute Drug Overdose

    PubMed Central

    Manini, Alex F.; Hoffman, Robert S.; Stimmel, Barry; Vlahov, David

    2015-01-01

    Objectives It was recently demonstrated that adverse cardiovascular events (ACVE) complicate a high proportion of hospitalizations for patients with acute drug overdoses. The aim of this study was to derive independent clinical risk factors for ACVE in patients with acute drug overdoses. Methods This prospective cohort study was conducted over 3 years at two urban university hospitals. Patients were adults with acute drug overdoses enrolled from the ED. In-hospital ACVE was defined as any of myocardial injury, shock, ventricular dysrhythmia, or cardiac arrest. Results There were 1,562 patients meeting inclusion/exclusion criteria (mean age, 41.8 years; female, 46%; suicidal, 38%). ACVE occurred in 82 (5.7%) patients (myocardial injury, 61; shock, 37; dysrhythmia, 23; cardiac arrests, 22) and there were 18 (1.2%) deaths. On univariate analysis, ACVE risk increased with age, lower serum bicarbonate, prolonged QTc interval, prior cardiac disease, and altered mental status. In a multivariable model adjusting for these factors as well as patient sex and hospital site, independent predictors were: QTc > 500 msec (3.8% prevalence, odds ratio [OR] 27.6), bicarbonate < 20 mEql/L (5.4% prevalence, OR 4.4), and prior cardiac disease (7.1% prevalence, OR 9.5). The derived prediction rule had 51.6% sensitivity, 93.7% specificity, and 97.1% negative predictive value; while presence of two or more risk factors had 90.9% positive predictive value. Conclusions The authors derived independent clinical risk factors for ACVE in patients with acute drug overdose, which should be validated in future studies as a prediction rule in distinct patient populations and clinical settings. PMID:25903997

  14. Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study

    PubMed Central

    Rodrigues, Beverly T.; Vangaveti, Venkat N.

    2016-01-01

    Objective. The aim of the study was to evaluate the prevalence of and risk factors for lower limb amputation in a specialist foot clinic-based setting. Methods. A retrospective quantitative study was conducted, using clinical and biochemical profiles of diabetic foot patients attending the High Risk Foot Clinic at The Townsville Hospital, Australia, between January 1, 2011, and December 31, 2013. Results. The total study sample included 129 subjects, comprising 81 males and 48 females with M : F ratio of 1.7 : 1. Twenty-three subjects were Indigenous Australians, representing 17.8% of the study population. The average age of the cohort was 63.4 years ± 14.1 years [CI 90.98–65.89]. Lower limb amputation was identified as a common and significant outcome (n = 44), occurring in 34.1%, more commonly amongst the Indigenous Australians (56.5% versus 29.2%; p = 0.94, OR 0.94). Risk factors most closely associated with amputation included diabetic retinopathy (p = 0.00, OR 4.4), coronary artery bypass graft (CABG) surgery (p = 0.01, OR 4.1), Charcot's arthropathy (p = 0.01, OR 2.9), and Indigenous ethnicity (p = 0.01, OR 3.4). Although average serum creatinine, corrected calcium, and glycosylated haemoglobin A1c (Hba1c) levels were higher amongst amputees they were statistically insignificant. Conclusions. Lower limb amputation is a common outcome and linked to ethnicity and neurovascular diabetic complications amongst subjects with diabetic foot ulcer. Further research is needed to identify why risk of lower limb amputation seems to differ according to ethnicity. PMID:27446962

  15. Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study.

    PubMed

    Rodrigues, Beverly T; Vangaveti, Venkat N; Malabu, Usman H

    2016-01-01

    Objective. The aim of the study was to evaluate the prevalence of and risk factors for lower limb amputation in a specialist foot clinic-based setting. Methods. A retrospective quantitative study was conducted, using clinical and biochemical profiles of diabetic foot patients attending the High Risk Foot Clinic at The Townsville Hospital, Australia, between January 1, 2011, and December 31, 2013. Results. The total study sample included 129 subjects, comprising 81 males and 48 females with M : F ratio of 1.7 : 1. Twenty-three subjects were Indigenous Australians, representing 17.8% of the study population. The average age of the cohort was 63.4 years ± 14.1 years [CI 90.98-65.89]. Lower limb amputation was identified as a common and significant outcome (n = 44), occurring in 34.1%, more commonly amongst the Indigenous Australians (56.5% versus 29.2%; p = 0.94, OR 0.94). Risk factors most closely associated with amputation included diabetic retinopathy (p = 0.00, OR 4.4), coronary artery bypass graft (CABG) surgery (p = 0.01, OR 4.1), Charcot's arthropathy (p = 0.01, OR 2.9), and Indigenous ethnicity (p = 0.01, OR 3.4). Although average serum creatinine, corrected calcium, and glycosylated haemoglobin A1c (Hba1c) levels were higher amongst amputees they were statistically insignificant. Conclusions. Lower limb amputation is a common outcome and linked to ethnicity and neurovascular diabetic complications amongst subjects with diabetic foot ulcer. Further research is needed to identify why risk of lower limb amputation seems to differ according to ethnicity. PMID:27446962

  16. [Systemic error analysis as a key element of clinical risk management].

    PubMed

    Bartz, Hans-Jürgen

    2015-01-01

    Systemic error analysis plays a key role in clinical risk management. This includes all clinical and administrative activities which identify, assess and reduce the risks of damage to patients and to the organization. The clinical risk management is an integral part of quality management. This is also the policy of the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) on the fundamental requirements of an internal quality management. The goal of all activities is to improve the quality of medical treatment and patient safety. Primarily this is done by a systemic analysis of incidents and errors. A results-oriented systemic error analysis needs an open and unprejudiced corporate culture. Errors have to be transparent and measures to improve processes have to be taken. Disciplinary action on staff must not be part of the process. If these targets are met, errors and incidents can be analyzed and the process can create added value to the organization. There are some proven instruments to achieve that. This paper discusses in detail the error and risk analysis (ERA), which is frequently used in German healthcare organizations. The ERA goes far beyond the detection of problems due to faulty procedures. It focuses on the analysis of the following contributory factors: patient factors, task and process factors, individual factors, team factors, occupational and environmental factors, psychological factors, organizational and management factors and institutional context. Organizations can only learn from mistakes by analyzing these factors systemically and developing appropriate corrective actions. This article describes the fundamentals and implementation of the method at the University Medical Center Hamburg-Eppendorf. PMID:25404172

  17. Receipt of clinical and prevention services, clinical outcomes, and sexual risk behaviors among HIV-infected young adults in care in the United States.

    PubMed

    Beer, Linda; Mattson, Christine L; Shouse, R Luke; Prejean, Joseph

    2016-09-01

    We describe receipt of clinical and prevention services, clinical outcomes, and sexual risk behaviors among young adult HIV patients in the United States during 2009-2013, using a sample designed to produce nationally representative estimates. Compared with older HIV patients, proportionately more young adults received provider-delivered prevention services and reported sexual risk behaviors. Young adults had similar care patterns as older HIV patients, but were less likely to have or adhere to an antiretroviral therapy prescription and achieve viral suppression. These estimates establish a national baseline from which to monitor changes in clinical outcomes and transmission behaviors among young HIV-infected adults. PMID:27011102

  18. Clinical probability and risk analysis of patients with suspected pulmonary embolism

    PubMed Central

    Yetgin, Gulden Ozeren; Aydin, Sule Akkose; Koksal, Ozlem; Ozdemir, Fatma; Mert, Dilek Kostak; Torun, Gokhan

    2014-01-01

    BACKGROUND: Pulmonary embolism (PE) is one of the most frequent diseases that could be missed in overcrowded emergency departments as in Turkey. Early and accurate diagnosis could decrease the mortality rate and this standard algorithm should be defined. This study is to find the accurate, fast, non-invasive, cost-effective, easy-to-access diagnostic tests, clinical scoring systems and the patients who should be tested for clinical diagnosis of PE in emergency department. METHODS: One hundred and forty patients admitted to the emergency department with the final diagnosis of PE regarding to anamnesis, physical examination and risk factors, were included in this prospective, cross-sectional study. The patients with a diagnosis of pulmonary embolism, acute coronary syndrome or infection and chronic obstructive pulmonary disease (COPD) were excluded from the study. The demographics, risk factors, radiological findings, vital signs, symptoms, physical-laboratory findings, diagnostic tests and clinical scoring systems of patients (Wells and Geneva) were noted. The diagnostic criteria for pulmonary emboli were: filling defect in the pulmonary artery lumen on spiral computed tomographic angiography and perfusion defect on perfusion scintigraphy. RESULTS: Totally, 90 (64%) of the patients had PE. Age, hypotension, having deep vein thrombosis were the risk factors, and oxygen saturation, shock index, BNP, troponin and fibrinogen levels as for the biochemical parameters were significantly different between the PE (+) and PE (−) groups (P<0.05). The Wells scoring system was more successful than the other scoring systems. CONCLUSION: Biochemical parameters, clinical findings, and scoring systems, when used altogether, can contribute to the diagnosis of PE. PMID:25548599

  19. Characteristics of Pseudoaneurysms in Northern India; Risk Analysis, Clinical Profile, Surgical Management and Outcome

    PubMed Central

    Lone, Hafeezulla; Ganaie, Farooq Ahmad; Lone, Ghulam Nabi; Dar, Abdul Majeed; Bhat, Mohammad Akbar; Singh, Shyam; Parra, Khursheed Ahmad

    2015-01-01

    Objective: To determine the risk factors, clinical characteristics, surgical management and outcome of pseudoaneurysm secondary to iatrogenic or traumatic vascular injury. Methods: This was a cross-sectional study being performed in department of cardiovascular and thoracic surgery skims soura during a 4-year period. We included all the patients referring to our center with primary diagnosis of pseudoaneurysm. The pseudoaneurysm was diagnosed with angiography and color Doppler sonography. The clinical and demographic characteristics were recorded and the risk factors were identified accordingly. Patients with small swelling (less than 5-cm) and without any complication were managed conservatively. They were followed for progression and development of complications in relation to swelling. Others underwent surgical repair and excision. The outcome of the patients was also recorded. Results: Overall we included 20 patients with pseudoaneurysm. The mean age of the patients was 42.1±0.6 years. Among them there were 11 (55%) men and 9 (45%) women. Nine (45%) patients with end stage renal disease developed pseudoaneurysm after inadvertent femoral artery puncture for hemodialysis; two patients after interventional cardiology procedure; one after femoral embolectomy; one developed after fire arm splinter injury and one formed femoral artery related pseudoaneurysm after drainage of right inguinal abscess. The most common site of pseudoaneurysm was femoral artery followed by brachial artery. Overall surgical intervention was performed in 17 (85%) patients and 3 (15%) were managed conservatively. Conclusion: End stage renal disease is a major risk factor for pseudoaneurysm formation. Coagulopathy, either therapeutic or pathological is also an important risk factor. Patients with these risk factors need cannulation of venous structures for hemodialysis under ultrasound guide to prevent inadvertent arterial injury. Patients with end stage renal disease who sustain inadvertent

  20. Risk prediction with procalcitonin and clinical rules in community-acquired pneumonia

    PubMed Central

    Huang, David T.; Weissfeld, Lisa A.; Kellum, John A.; Yealy, Donald M.; Kong, Lan; Martino, Michael; Angus, Derek C.

    2009-01-01

    Objective The Pneumonia Severity Index (PSI) and CURB-65 predict outcomes in community acquired pneumonia (CAP), but have limitations. Procalcitonin, a biomarker of bacterial infection, may provide prognostic information in CAP. Our objective was to describe the pattern of procalcitonin in CAP, and determine if procalcitonin provides prognostic information beyond PSI and CURB-65. Methods We conducted a multi-center prospective cohort study in 28 community and teaching emergency departments. Patients presenting with a clinical and radiographic diagnosis of CAP were enrolled. We stratified procalcitonin levels a priori into four tiers – I: < 0.1; II: ≥ 0.1 to <0.25; III: ≥ 0.25 to < 0.5; and IV: ≥ 0.5 ng/ml. Primary outcome was 30d mortality. Results 1651 patients formed the study cohort. Procalcitonin levels were broadly spread across tiers: 32.8% (I), 21.6% (II), 10.2% (III), 35.4% (IV). Used alone, procalcitonin had modest test characteristics: specificity (35%), sensitivity (92%), positive likelihood ratio (LR) (1.41), and negative LR (0.22). Adding procalcitonin to PSI in all subjects minimally improved performance. Adding procalcitonin to low risk PSI subjects (Class I–III) provided no additional information. However, subjects in procalcitonin tier I had low 30d mortality regardless of clinical risk, including those in higher risk classes (1.5% vs. 1.6% for those in PSI Class I–III vs. Class IV/V). Among high risk PSI subjects (Class IV/V), one quarter (126/546) were in procalcitonin tier I, and the negative LR of procalcitonin tier I was 0.09. Procalcitonin tier I was also associated with lower burden of other adverse outcomes. Similar results were seen with CURB-65 stratification. Conclusions Selective use of procalcitonin as an adjunct to existing rules may offer additional prognostic information in high risk patients. PMID:18342993

  1. Social dysfunction predicts two years clinical outcome in people at ultra high risk for psychosis.

    PubMed

    Fusar-Poli, P; Byrne, M; Valmaggia, L; Day, F; Tabraham, P; Johns, L; McGuire, P

    2010-04-01

    The experience of a first psychotic episode is associated with a marked impairment in psychosocial functioning. However, the decline may be already evident in the pre-psychotic phases and play a significant role in the etiopathology of the disease onset. A sample of subjects at ultra high clinical risk for psychosis ("At Risk Mental State", ARMS, n=152) was compared with a demographically-matched general population (n=98,072) on different measures of psychosocial functioning. The proportion of subjects with an ARMS living in communal establishments or living at home with their parents was significantly higher than that of the local population (p<0.001). Subjects with an ARMS showed also higher rates of unemployment as compared to the general population (p<0.001). GAF scores at baseline were significantly lower in unemployed ARMS as compared to students and employed ARMS (p=0.002). ARMS subjects living in communal establishments presented higher rates of co-morbid psychiatric conditions (p=0.007) and lower GAF scores at baseline (p=0.017). Finally, baseline unemployment and living in a communal establishment were associated with an increased risk of developing a psychotic episode within the following two years (p<0.05). We concluded that the "At Risk Mental State" is a clinical condition which is characterized by marked psychosocial impairment and by an increased vulnerability to psychosis. Unemployment at the first contact with the prodromal service may be a risk factor for the development of a psychotic episode. PMID:19836755

  2. Physiotherapists working in clinics have increased risk for new-onset spine disorders

    PubMed Central

    Liao, Jen-Chieh; Ho, Chung-Han; Chiu, Haw-Yen; Wang, Yu-Lin; Kuo, Li-Chieh; Liu, Cheng; Wang, Jhi-Joung; Lim, Sher-Wei; Kuo, Jinn-Rung

    2016-01-01

    Abstract Health care professionals are known to have a high risk for work-related musculoskeletal disorders. However, the information on the risk of new-onset spine-related musculoskeletal disorders (SRMDs) in health care professionals is insufficient. This study aimed to investigate new-onset spine disorder associations among physical, occupational, and pharmacy health care professionals working in different workplaces. Taiwan's National Health Insurance Research Database for registered medical personnel claims from 2000 to 2011 was analyzed. An age- and sex-matched longitudinal cohort study of 7448 subjects (1682 physiotherapists, 1682 occupational therapists [OTs], and 3724 pharmacists) with or without new-onset spine disorders was conducted. The hazard ratios for the development of new-onset spine disorders were estimated among these 3 groups. The overall percentage of new-onset SRMD for physiotherapists is 32.12. The median time from obtaining a registered license to developing SRMD is 1.94 years. The log-rank test showed that physiotherapists have the least possibility of having a SRMD-free rate (P < 0.0001). The Cox model showed that physiotherapists have a higher risk of new-onset SRMD (hazard ratio: 1.65, 95% confidence interval: 1.48–1.84, P < 0.0001) compared with OTs and pharmacists. Physiotherapists working in clinics have a 2.40-fold increased risk of developing SRMD (95% confidence interval: 1.97–2.92, P < 0.0001) relative to OTs and pharmacists. This may be the first study regarding new-onset SRMD in physiotherapists based on a powerful nationwide population-based database. We conclude that working in clinics is a potential risk for new-onset SRMD in physiotherapists. Therefore, we suggest that physiotherapists should pay more attention to this issue to prevent the development of spine disorders. PMID:27512853

  3. Bladder Carcinoma Data with Clinical Risk Factors and Molecular Markers: A Cluster Analysis

    PubMed Central

    Redondo-Gonzalez, Enrique; de Castro, Leandro Nunes; Moreno-Sierra, Jesús; Maestro de las Casas, María Luisa; Vera-Gonzalez, Vicente; Ferrari, Daniel Gomes; Corchado, Juan Manuel

    2015-01-01

    Bladder cancer occurs in the epithelial lining of the urinary bladder and is amongst the most common types of cancer in humans, killing thousands of people a year. This paper is based on the hypothesis that the use of clinical and histopathological data together with information about the concentration of various molecular markers in patients is useful for the prediction of outcomes and the design of treatments of nonmuscle invasive bladder carcinoma (NMIBC). A population of 45 patients with a new diagnosis of NMIBC was selected. Patients with benign prostatic hyperplasia (BPH), muscle invasive bladder carcinoma (MIBC), carcinoma in situ (CIS), and NMIBC recurrent tumors were not included due to their different clinical behavior. Clinical history was obtained by means of anamnesis and physical examination, and preoperative imaging and urine cytology were carried out for all patients. Then, patients underwent conventional transurethral resection (TURBT) and some proteomic analyses quantified the biomarkers (p53, neu, and EGFR). A postoperative follow-up was performed to detect relapse and progression. Clusterings were performed to find groups with clinical, molecular markers, histopathological prognostic factors, and statistics about recurrence, progression, and overall survival of patients with NMIBC. Four groups were found according to tumor sizes, risk of relapse or progression, and biological behavior. Outlier patients were also detected and categorized according to their clinical characters and biological behavior. PMID:25866762

  4. Clinical and psychological telemonitoring and telecare of high risk heart failure patients.

    PubMed

    Villani, Alessandra; Malfatto, Gabriella; Compare, Angelo; Della Rosa, Francesco; Bellardita, Lara; Branzi, Giovanna; Molinari, Enrico; Parati, Gianfranco

    2014-12-01

    We conducted a trial of telemonitoring and telecare for patients with chronic heart failure leaving hospital after being treated for clinical instability. Eighty patients were randomized before hospital discharge to a usual care group (n=40: follow-up at the outpatient clinic) or to an integrated management group (n=40: patients learned to use a handheld PDA and kept in touch daily with the monitoring centre). At enrolment, the groups were similar for all clinical variables. At one-year follow-up, integrated management patients showed better adherence, reduced anxiety and depression, and lower NYHA class and plasma levels of BNP with respect to the usual care patients (e.g. NYHA class 2.1 vs 2.4, P<0.02). Mortality and hospital re-admissions for congestive heart failure were also reduced in integrated management patients (P<0.05). Integrated management was more expensive than usual care, although the cost of adverse events was 42% lower. In heart failure patients at high risk of relapse, the regular acquisition of simple clinical information and the possibility for the patient to contact the clinical staff improved drug titration, produced better psychological status and quality of life, and reduced hospitalizations for heart failure. PMID:25339632

  5. Weighing the evidence: Risks and benefits of participatory documentary in corporatized clinics

    PubMed Central

    Hansen, Helena

    2014-01-01

    This paper describes the effects of one U.S.-based public psychiatry clinic’s shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on “evidence based” treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends. PMID:23932854

  6. Risk factors for HIV infection in people attending clinics for sexually transmitted diseases in India.

    PubMed Central

    Rodrigues, J. J.; Mehendale, S. M.; Shepherd, M. E.; Divekar, A. D.; Gangakhedkar, R. R.; Quinn, T. C.; Paranjape, R. S.; Risbud, A. R.; Brookmeyer, R. S.; Gadkari, D. A.

    1995-01-01

    OBJECTIVE--To investigate the risk factors for HIV infection in patients attending clinics for sexually transmitted diseases in India. DESIGN--Descriptive study of HIV serology, risk behaviour, and findings on physical examination. SUBJECTS--2800 patients presenting to outpatient clinics between 13 May 1993 and 15 July 1994. SETTING--Two clinics and the National AIDS Research Institute, in Pune, Maharashtra State, India. MAIN OUTCOME MEASURE--HIV status, presence of sexually transmitted diseases, and sexual behaviour. RESULTS--The overall proportion of patients infected with HIV was 23.4% (655/2800); 34% (184) of the women and 21% (459) of the men were positive for HIV infection. Of the 560 women screened, 338 (60%) had a reported history of sex working, of whom 153 (45%) were infected with HIV-1. The prevalence of HIV-1 infection in the 222 women who were not sex workers was 14%. The significant independent characteristics associated with HIV infection based on a logistic regression analysis included being a female sex worker, sexual contact with a sex worker, lack of formal education, receptive anal sex in the previous three months, lack of condom use in the previous three months, current or previous genital ulcer or genital discharge, and a positive result of a Venereal Disease Research Laboratory test. CONCLUSIONS--In India the prevalence of HIV infection is alarmingly high among female sex workers and men attending clinics for sexually transmitted diseases, particularly in those who had recently had contact with sex workers. A high prevalence of HIV infection was also found in monogamous, married women presenting to the clinics who denied any history of sex working. The HIV epidemic in India is primarily due to heterosexual transmission of HIV-1 and, as in other countries, HIV infection is associated with ulcerative and non-ulcerative sexually transmitted diseases. PMID:7633230

  7. Explaining the clinical manifestations of T wave alternans in patients at risk for sudden cardiac death

    PubMed Central

    Cutler, Michael J; Rosenbaum, David S.

    2009-01-01

    The mechanisms underlying sudden cardiac death (SCD) are complex and diverse. Therefore, correct application of any marker to risk stratify patients for appropriate therapy requires knowledge regarding how the marker is reflective of a particular electro-anatomical substrate for arrhythmias. Non-invasive measurement of beat-to-beat alternation of the electrocardiographic T-wave, referred to as T-wave alternans (TWA), is an important marker of risk for sudden cardiac death (SCD). Is this relationship a mere association or is TWA mechanistically linked to SCD? Recent experimental evidence strongly supports a mechanistic relationship between TWA and SCD. This review will consider the underlying mechanisms of TWA derived from experimental studies, as they relate to clinical observations of TWA in humans, addressing the following questions derived from common clinical observations: 1) Where does TWA on the surface ECG come from? 2) Why is controlled heart rate elevation required to elicit TWA? 3) Why is TWA associated with risk for SCD? 4) Why is TWA associated with a broad range of ventricular arrhythmias? and 5) How do commonly used medications affect TWA? PMID:19168395

  8. Clinical Presentation, Risk Factors, and Treatment Modalities of Hepatocellular Carcinoma: A Single Tertiary Care Center Experience

    PubMed Central

    AlZunaitan, Mohammed; Al Ghobain, Mohammed; Al Muaikeel, Mohamed; Al Olayan, Ashwaq; Azzumeea, Fahad; AlAlwan, Abduljaleel; AlGhamdi, Hamdan

    2016-01-01

    Objective. To investigate the risk factors, clinical characteristics, treatment modalities, and outcomes in Saudi patients with HCC and propose points for early detection of the disease. Methods. Patients were stratified according to underlying risk factors for the development of HCC. Barcelona Clinic Liver Cancer (BCLC) was used for cancer staging. Treatment was classified into surgical resection/liver transplantation; locoregional ablation therapy; transarterial embolization; systemic chemotherapy; and best supportive care. Results. A total of 235 patients were included. Males had higher tumor size and incidence of portal vein thrombosis. Viral hepatitis was a risk factor in 75.7%. The most common BCLC stages were B (34.5%) and A (33.6%), and the most common radiological presentation was a single nodule of less than 5 cm. Metastases were present in 13.2%. Overall, 77 patients (32.8%) underwent a potentially curative treatment as the initial therapy. The most commonly utilized treatment modality was chemoembolization with 113 sessions in 71 patients. The overall median survival was 15.97 ± 27.18 months. Conclusion. HCC in Saudi Arabia is associated with high prevalence of HCV. Potentially curative therapies were underutilized in our patients. Cancer stage BCLC-B was the most frequent (34.5%) followed by BCLC-A (33.6%). The overall median survival was shorter than other studies. PMID:27525001

  9. Predicting the risk of suicide by analyzing the text of clinical notes.

    PubMed

    Poulin, Chris; Shiner, Brian; Thompson, Paul; Vepstas, Linas; Young-Xu, Yinong; Goertzel, Benjamin; Watts, Bradley; Flashman, Laura; McAllister, Thomas

    2014-01-01

    We developed linguistics-driven prediction models to estimate the risk of suicide. These models were generated from unstructured clinical notes taken from a national sample of U.S. Veterans Administration (VA) medical records. We created three matched cohorts: veterans who committed suicide, veterans who used mental health services and did not commit suicide, and veterans who did not use mental health services and did not commit suicide during the observation period (n = 70 in each group). From the clinical notes, we generated datasets of single keywords and multi-word phrases, and constructed prediction models using a machine-learning algorithm based on a genetic programming framework. The resulting inference accuracy was consistently 65% or more. Our data therefore suggests that computerized text analytics can be applied to unstructured medical records to estimate the risk of suicide. The resulting system could allow clinicians to potentially screen seemingly healthy patients at the primary care level, and to continuously evaluate the suicide risk among psychiatric patients.

  10. A clinical approach to obstructive sleep apnea as a risk factor for cardiovascular disease

    PubMed Central

    Maeder, Micha T; Schoch, Otto D; Rickli, Hans

    2016-01-01

    Obstructive sleep apnea (OSA) is associated with cardiovascular risk factors, cardiovascular diseases, and increased mortality. Epidemiological studies have established these associations, and there are now numerous experimental and clinical studies which have provided information on the possible underlying mechanisms. Mechanistic proof-of-concept studies with surrogate endpoints have been performed to demonstrate that treatment of OSA by continuous positive airway pressure (CPAP) has the potential to reverse or at least to attenuate not only OSA but also the adverse cardiovascular effects associated with OSA. However, no randomized studies have been performed to demonstrate that treatment of OSA by CPAP improves clinical outcomes in patients with cardiovascular risk factors and/or established cardiovascular disease and concomitant OSA. In the present review, we summarize the current knowledge on the role of OSA as a potential cardiovascular risk factor, the impact of OSA on cardiac function, the role of OSA as a modifier of the course of cardiovascular diseases such as coronary artery disease, atrial fibrillation, and heart failure, and the insights from studies evaluating the impact of CPAP therapy on the cardiovascular features associated with OSA. PMID:27051291

  11. Methodologic issues in clinical trials for prevention or risk reduction in osteoarthritis.

    PubMed

    Jordan, J M; Sowers, M F; Messier, S P; Bradley, J; Arangio, G; Katz, J N; Losina, E; Rovati, L; Bachtell, N; Cooper, C; Spector, T; Zhang, W; Gardiner, J; Wahba, M

    2011-05-01

    The design and execution of prevention trials for OA have methodological issues that are distinct from trials designed to impact prevalent disease. Disease definitions and their precise and sensitive measurement, identification of high-risk populations, the nature of the intervention (pharmaceutical, nutraceutical, behavioral) and its potential pleiotropic impacts on other organ systems are critical to consider. Because prevention trials may be prolonged, close attention to concomitant life changes and co-morbidities, adherence and participant retention in the trial is of primary importance, as is recognition of the potential for "preventive misconception" and "behavioral disinhibition" to affect the ability of the trial to show an effect of the intervention under study. None of these potential pitfalls precludes a successful and scientifically rigorous process and outcome. As technology improves the means to measure and predict the OA process and its clinical consequences, it will be increasingly possible to screen individuals for high-risk phenotypes, combining clinical factors with information from imaging, genetic, metabolic and other biomarkers and to impact this high-risk condition to avoid or delay OA both structurally and symptomatically. PMID:21396470

  12. Reciprocal social behavior in youths with psychotic illness and those at clinical high risk

    PubMed Central

    Jalbrzikowski, Maria; Krasileva, Kate E.; Marvin, Sarah; Zinberg, Jamie; Andaya, Angielette; Bachman, Peter; Cannon, Tyrone D.; Bearden, Carrie E.

    2015-01-01

    Youths at clinical high risk (CHR) for psychosis typically exhibit significant social dysfunction. However, the specific social behaviors associated with psychosis risk have not been well characterized. We administer the Social Responsiveness Scale (SRS), a measure of autistic traits that examines reciprocal social behavior, to the parents of 117 adolescents (61 CHR individuals, 20 age-matched adolescents with a psychotic disorder [AOP], and 36 healthy controls) participating in a longitudinal study of psychosis risk. AOP and CHR individuals have significantly elevated SRS scores relative to healthy controls, indicating more severe social deficits. Mean scores for AOP and CHR youths are typical of scores obtained in individuals with high functioning autism (Constantino & Gruber, 2005). SRS scores are significantly associated with concurrent real-world social functioning in both clinical groups. Finally, baseline SRS scores significantly predict social functioning at follow-up (an average of 7.2 months later) in CHR individuals, over and above baseline social functioning measures ( p < .009). These findings provide novel information regarding impairments in domains critical for adolescent social development, because CHR individuals and those with overt psychosis show marked deficits in reciprocal social behavior. Further, the SRS predicts subsequent real-world social functioning in CHR youth, suggesting that this measure may be useful for identifying targets of treatment in psychosocial interventions. PMID:24229557

  13. Psychopathy in women: a review of its clinical usefulness for assessing risk for aggression and criminality.

    PubMed

    Nicholls, Tonia L; Ogloff, James R P; Brink, Johann; Spidel, Alicia

    2005-01-01

    Despite a flurry of studies examining psychopathy in women, and the recent release of the second version of the Hare Psychopathy Checklist--Revised manual, there is still little consensus whether the lateral extension of the current conceptualization of psychopathy to women is appropriate. In particular, very little agreement exists concerning the clinical utility of the Hare psychopathy measures to assess women's risk of future offending and violence. This article presents a comprehensive review of studies of the association between psychopathy, antisocial behavior, and violence, in diverse samples of women, and looks at similarities and differences between these constructs in males and females. Findings from inmates and offenders, civil and forensic psychiatric patients, substance abusers, and community samples indicate a consistently lower base rate of psychopathy among women than among men. With some exceptions, correlates of psychopathy in women relevant to risk assessments for crime and violence tend to be modest and significant, generally mirroring what we see in men. Clinicians and policy makers charged with the care and management of women at risk for criminal offending and violence are likely to find the PCL-R and PCL:SV have clinical utility; however, cautious application is called for and ongoing research is required. PMID:16333808

  14. Mining heart disease risk factors in clinical text with named entity recognition and distributional semantic models.

    PubMed

    Urbain, Jay

    2015-12-01

    We present the design, and analyze the performance of a multi-stage natural language processing system employing named entity recognition, Bayesian statistics, and rule logic to identify and characterize heart disease risk factor events in diabetic patients over time. The system was originally developed for the 2014 i2b2 Challenges in Natural Language in Clinical Data. The system's strengths included a high level of accuracy for identifying named entities associated with heart disease risk factor events. The system's primary weakness was due to inaccuracies when characterizing the attributes of some events. For example, determining the relative time of an event with respect to the record date, whether an event is attributable to the patient's history or the patient's family history, and differentiating between current and prior smoking status. We believe these inaccuracies were due in large part to the lack of an effective approach for integrating context into our event detection model. To address these inaccuracies, we explore the addition of a distributional semantic model for characterizing contextual evidence of heart disease risk factor events. Using this semantic model, we raise our initial 2014 i2b2 Challenges in Natural Language of Clinical data F1 score of 0.838 to 0.890 and increased precision by 10.3% without use of any lexicons that might bias our results.

  15. A clinical risk score of myocardial fibrosis predicts adverse outcomes in aortic stenosis

    PubMed Central

    Chin, Calvin W.L.; Messika-Zeitoun, David; Shah, Anoop S.V.; Lefevre, Guillaume; Bailleul, Sophie; Yeung, Emily N.W.; Koo, Maria; Mirsadraee, Saeed; Mathieu, Tiffany; Semple, Scott I.; Mills, Nicholas L.; Vahanian, Alec; Newby, David E.; Dweck, Marc R.

    2016-01-01

    Aims Midwall myocardial fibrosis on cardiovascular magnetic resonance (CMR) is a marker of early ventricular decompensation and adverse outcomes in aortic stenosis (AS). We aimed to develop and validate a novel clinical score using variables associated with midwall fibrosis. Methods and results One hundred forty-seven patients (peak aortic velocity (Vmax) 3.9 [3.2,4.4] m/s) underwent CMR to determine midwall fibrosis (CMR cohort). Routine clinical variables that demonstrated significant association with midwall fibrosis were included in a multivariate logistic score. We validated the prognostic value of the score in two separate outcome cohorts of asymptomatic patients (internal: n = 127, follow-up 10.3 [5.7,11.2] years; external: n = 289, follow-up 2.6 [1.6,4.5] years). Primary outcome was a composite of AS-related events (cardiovascular death, heart failure, and new angina, dyspnoea, or syncope). The final score consisted of age, sex, Vmax, high-sensitivity troponin I concentration, and electrocardiographic strain pattern [c-statistic 0.85 (95% confidence interval 0.78–0.91), P < 0.001; Hosmer–Lemeshow χ2 = 7.33, P = 0.50]. Patients in the outcome cohorts were classified according to the sensitivity and specificity of this score (both at 98%): low risk (probability score <7%), intermediate risk (7–57%), and high risk (>57%). In the internal outcome cohort, AS-related event rates were >10-fold higher in high-risk patients compared with those at low risk (23.9 vs. 2.1 events/100 patient-years, respectively; log rank P < 0.001). Similar findings were observed in the external outcome cohort (31.6 vs. 4.6 events/100 patient-years, respectively; log rank P < 0.001). Conclusion We propose a clinical score that predicts adverse outcomes in asymptomatic AS patients and potentially identifies high-risk patients who may benefit from early valve replacement. PMID:26491110

  16. RISK OF HEMOPTYSIS IN CYSTIC FIBROSIS CLINICAL TRIALS: A RETROSPECTIVE COHORT STUDY

    PubMed Central

    Mayer-Hamblett, N.; Kloster, M.; Bilton, D.; Flume, P. A.

    2015-01-01

    Background Cystic fibrosis (CF) is characterized by airways infection and inflammation resulting in respiratory complications including hemoptysis. The objectives of this study were to characterize risk of hemoptysis attributable to the underlying disease and in the presence of standard of care therapy. Methods This retrospective cohort study estimated hemoptysis rates overall and by relevant risk factors utilizing adverse event data from longitudinal prospective CF clinical trials. Results Of the 1008 participants, 73% were ≤18 years old; of 929 with available spirometry, 27% had an FEV1 < 70% predicted. During the average 8.2 months of follow-up, 8% experienced ≥1 hemoptysis events (95% CI: 6%, 10%). Of the 125 events, 76% were mild in severity and only 9% were serious. Hemoptysis rates were greater among adults than children, those with FEV1 < 70% predicted, and participants infected with P. aeruginosa but not with S. aureus. Conclusions Hemoptysis is a common adverse event among CF clinical trial participants, and particularly in adults with more severe lung disease. These results can be used to predict event occurrence in future clinical trials. PMID:25725985

  17. High number of previous Plasmodium falciparum clinical episodes increases risk of future episodes in a sub-group of individuals.

    PubMed

    Loucoubar, Cheikh; Grange, Laura; Paul, Richard; Huret, Augustin; Tall, Adama; Telle, Olivier; Roussilhon, Christian; Faye, Joseph; Diene-Sarr, Fatoumata; Trape, Jean-François; Mercereau-Puijalon, Odile; Sakuntabhai, Anavaj; Bureau, Jean-François

    2013-01-01

    There exists great disparity in the number of clinical P. falciparum episodes among children of the same age and living in similar conditions. The epidemiological determinants of such disparity are unclear. We used a data-mining approach to explore a nineteen-year longitudinal malaria cohort study dataset from Senegal and identify variables associated with increased risk of malaria episodes. These were then verified using classical statistics and replicated in a second cohort. In addition to age, we identified a novel high-risk group of children in whom the history of P. falciparum clinical episodes greatly increased risk of further episodes. Age and a high number of previous falciparum clinical episodes not only play major roles in explaining the risk of P. falciparum episodes but also are risk factors for different groups of people. Combined, they explain the majority of falciparum clinical attacks. Contrary to what is widely believed, clinical immunity to P. falciparum does not de facto occur following many P. falciparum clinical episodes. There exist a sub-group of children who suffer repeated clinical episodes. In addition to posing an important challenge for population stratification during clinical trials, this sub-group disproportionally contributes to the disease burden and may necessitate specific prevention and control measures.

  18. Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials

    PubMed Central

    Fisher, Jill A.

    2015-01-01

    Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. PMID:25914430

  19. The influence of actuarial risk assessment in clinical judgments and tribunal decisions about mentally disordered offenders in maximum security.

    PubMed

    Hilton, N Z; Simmons, J L

    2001-08-01

    Research has shown that actuarial assessments of violence risk are consistently more accurate than unaided judgments by clinicians, and it has been suggested that the availability of actuarial instruments will improve forensic decision making. This study examined clinical judgments and autonomous review tribunal decisions to detain forensic patients in maximum security. Variables included the availability of an actuarial risk report at the time of decision making, patient characteristics and history, and clinical presentation over the previous year. Detained and transferred patients did not differ in their actuarial risk of violent recidivism. The best predictor of tribunal decision was the senior clinician's testimony. There was also no significant association between the actuarial risk score and clinicians' opinions. Whether the actuarial report was available at the time of decision making did not alter the statistical model of either clinical judgments or tribunal decisions. Implications for the use of actuarial risk assessment in forensic decision making are discussed.

  20. Collagen content as a risk factor in breast cancer? A pilot clinical study

    NASA Astrophysics Data System (ADS)

    Pifferi, Antonio; Quarto, Giovanna; Abbate, Francesca; Balestreri, Nicola; Menna, Simona; Cassano, Enrico; Cubeddu, Rinaldo; Taroni, Paola

    2015-07-01

    A retrospective pilot clinical study on time domain multi-wavelength (635 to 1060 nm) optical mammography was exploited to assess collagen as a breast-cancer risk factor on a total of 109 subjects (53 healthy and 56 with malignant lesions). An increased cancer occurrence is observed on the 15% subset of patients with higher age-matched collagen content. Further, a similar clustering based on the percentage breast density leads to a different set of patients, possibly indicating collagen as a new independent breast cancer risk factor. If confirmed statistically and on larger numbers, these results could have huge impact on personalized diagnostics, health care systems, as well as on basic research.

  1. The Subjective Experience of Youths at Clinical High Risk for Psychosis: A Qualitative Study

    PubMed Central

    Ben-David, Shelly; Birnbaum, Michael; Eilenberg, Mara; DeVylder, Jordan; Gill, Kelly; Schienle, Jessica; Azimov, Neyra; Lukens, Ellen P.; Davidson, Larry; Corcoran, Cheryl Mary

    2015-01-01

    Objective Understanding the experience of individuals across stages of schizophrenia is important for development of services to promote recovery. As yet, little is known about the experience of individuals who exhibit prodromal symptoms of schizophrenia. Methods Audiotaped interviews were conducted with 27 participants at clinical high risk (CHR) for psychosis (15 males; 12 females; mean age 21; ethnically diverse). Phenomenological qualitative research techniques of coding, consensus, and comparison were used. Results Emergent themes differed by gender. Themes for males were feeling abnormal or “broken”; focus on going “crazy”; fantasy and escapism; and alienation and despair, with a desire for relationships. Themes for females were psychotic illness in family members; personal trauma; struggle with intimate relationships; and career and personal development. Conclusions The finding of relative social engagement and future-orientation of females identified as at risk for psychosis is novel, and has implications for outreach and treatment. PMID:25179420

  2. Muscle cramping in athletes--risk factors, clinical assessment, and management.

    PubMed

    Schwellnus, Martin P; Drew, Nichola; Collins, Malcolm

    2008-01-01

    Exercise associated muscle cramping (EAMC) is defined as a painful, spasmodic, and involuntary contraction of skeletal muscle that occurs during or immediately after exercise. There is a high lifetime prevalence of EAMC in athletes, specifically in endurance athletes. The most important risk factors for EAMC in athletes are a previous history of EAMC, and performing exercise at a higher relative exercise intensity or duration, when compared with normal training and participating in hot and humid environmental conditions. The diagnosis of EAMC is made clinically, and the most effective immediate management of EAMC is rest and passive stretching. The key to the prevention of EAMC is to reduce the risk of developing premature muscle fatigue.

  3. Coping Styles of Individuals at Clinical High Risk for Developing Psychosis

    PubMed Central

    Jalbrzikowski, Maria; Sugar, Catherine A.; Zinberg, Jamie; Bachman, Peter; Cannon, Tyrone D.; Bearden, Carrie E.

    2012-01-01

    Aim There is a wealth of evidence suggesting that patients with schizophrenia tend to respond to life stressors using less effective coping skills, which are in turn related to poor outcome. However, the contribution of coping strategies to outcome in youth at clinical high risk (CHR) for developing psychosis has not been investigated. Methods This longitudinal study followed CHR youth over a twelve-month period, using the Brief COPE questionnaire. CHR subjects (n=88) were compared at baseline to a healthy control sample (n=53), and then mixed models were used to explore the relationship of coping strategies to clinical and psychosocial outcomes in CHR subjects over time (n=102). Results Cross-sectional analyses revealed that, in comparison to healthy controls, CHR youth reported using more maladaptive coping strategies (p<.001) and fewer adaptive coping strategies (p<.01). Longitudinal analyses within the CHR group showed significant decreases in maladaptive coping and symptom severity over time, with corresponding improvements in social and role functioning. Adaptive coping was associated with better concurrent social functioning and less severe symptomatology (both p<.001). Over time, more maladaptive coping was associated with more severe positive and negative symptoms (both p < .005). Conclusions Youth at-risk for psychosis report using fewer adaptive and more maladaptive coping strategies relative to healthy controls. Over one year follow-up, more adaptive coping styles are associated with less severe clinical symptomatology and better social functioning. These findings suggest that teaching adaptive coping styles may be an important target for intervention in youth at high risk for psychosis. PMID:23164368

  4. Using Claims Data to Generate Clinical Flags Predicting Short-term Risk of Continued Psychiatric Hospitalizations

    PubMed Central

    Stein, Bradley D.; Pangilinan, Maria; Sorbero, Mark J; Marcus, Sue; Donahue, Sheila; Xu, Yan; Smith, Thomas E; Essock, Susan M

    2014-01-01

    Objective As health information technology advances, efforts to use administrative data to inform real-time treatment planning for individuals are increasing, despite few empirical studies demonstrating that such administrative data predict subsequent clinical events. Medicaid claims for individuals with frequent psychiatric hospitalizations were examined to test how well patterns of service use predict subsequent high short-term risk of continued psychiatric hospitalizations. Methods Medicaid claims files from New York and Pennsylvania were used to identify Medicaid recipients aged 18-64 with two or more inpatient psychiatric admissions during a target year ending March 31, 2009. Definitions from a quality-improvement initiative were used to identify patterns of inpatient and outpatient service use and prescription fills suggestive of clinical concerns. Generalized estimating equations and Markov models were applied to examine claims through March, 2011, to see what patterns of service use were sufficiently predictive of additional hospitalizations to be clinically useful. Results 11,801 unique individuals in New York and 1,859 in Pennsylvania identified met the cohort definition. In both Pennsylvania and New York, multiple recent hospitalizations, but not failure to use outpatient services or failure to fill medication prescriptions, were significant predictors of high risk of continued frequent hospitalizations, with odds ratios greater than 4.0. Conclusions Administrative data can be used to identify individuals at high risk of continued frequent hospitalizations. Such information could be used by payers and system administrators to authorize special services (e.g., mobile outreach) for such individuals as part of efforts to promote service engagement and prevent rapid rehospitalizations. PMID:25022360

  5. Medical Risk Assessment in Patients Referred to Dental Clinics, Mashhad, Iran (2011-2012)

    PubMed Central

    Maryam, Amirchaghmaghi; Atessa, Pakfetrat; Mozafari Pegah, Mosannen; Zahra, Shafiee; Hanieh, Ghalavani; Davood, Aghasizadeh; Yeganeh, Khazaei

    2015-01-01

    Advances in medical and dental techniques have led to a growing aged population living with complex medical conditions. This study focuses on the detection of medically compromised dental patients by means of a validated patient-administered medical risk-related history questionnaire. Materials and Methods: We used the questionnaire EMRRH (European Risk Related Medical History) in order to study the prevalence as well as the risk assessment of past medical problems in a population who visited dental centers (dental university, dental offices and clinics) for treatment in Mashhad, Iran. Results: A total number of 1,188 patients were registered, 871 of whom had a medical history that was of some interest to us. From the population with medical problems which was 30.6% of the total (N=219), 26.7% of the patients were classified as risk ASA I; 37.3% as ASA II, 16.9% as ASA III; and 19.1% as ASA IV. Among the diverse pathologies, the highest percentage was hypertension (11.6%), followed by allergies to different drugs (8.37%). Conclusion: It seems absolutely essential for dental practitioners to take a detailed medical history prior to any therapeutic procedure, as certain medical conditions, if unnoticed, will lead to unfavorable consequences and/or repercussions. PMID:26966468

  6. A Clinical Prediction Model to Stratify Retinopathy of Prematurity Risk Using Postnatal Weight Gain

    PubMed Central

    Ying, Gui-shuang; Quinn, Graham E.; Dreiseitl, Stephan; Karp, Karen; Roberts, Robin S.; Kirpalani, Haresh

    2011-01-01

    OBJECTIVE: To develop an efficient clinical prediction model that includes postnatal weight gain to identify infants at risk of developing severe retinopathy of prematurity (ROP). Under current birth weight (BW) and gestational age (GA) screening criteria, <5% of infants examined in countries with advanced neonatal care require treatment. PATIENTS AND METHODS: This study was a secondary analysis of prospective data from the Premature Infants in Need of Transfusion Study, which enrolled 451 infants with a BW < 1000 g at 10 centers. There were 367 infants who remained after excluding deaths (82) and missing weights (2). Multivariate logistic regression was used to predict severe ROP (stage 3 or treatment). RESULTS: Median BW was 800 g (445–995). There were 67 (18.3%) infants who had severe ROP. The model included GA, BW, and daily weight gain rate. Run weekly, an alarm that indicated need for eye examinations occurred when the predicted probability of severe ROP was >0.085. This identified 66 of 67 severe ROP infants (sensitivity of 99% [95% confidence interval: 94%–100%]), and all 33 infants requiring treatment. Median alarm-to-outcome time was 10.8 weeks (range: 1.9–17.6). There were 110 (30%) infants who had no alarm. Nomograms were developed to determine risk of severe ROP by BW, GA, and postnatal weight gain. CONCLUSION: In a high-risk cohort, a BW-GA-weight-gain model could have reduced the need for examinations by 30%, while still identifying all infants requiring laser surgery. Additional studies are required to determine whether including larger-BW, lower-risk infants would reduce examinations further and to validate the prediction model and nomograms before clinical use. PMID:21321036

  7. West Nile virus infection in horses in Jordan: clinical cases, seroprevalence and risk factors.

    PubMed

    Abutarbush, S M; Al-Majali, A M

    2014-08-01

    The objectives of this study are to report clinical WNV infection in horses and to determine the seroprevalence of and risk factors for WNV infection in horses in Jordan. In late summer and early fall of 2012, two mares were presented for evaluation of neurological signs. The first mare had hind-limb ataxia. The second mare was slightly depressed and lethargic. She had ataxia in her four limbs and cranial nerves deficits. Both horses were found positive for WNV IgM antibodies using commercial IgM-capture ELISA test. Both horses were treated symptomatically and recovered uneventfully. The occurrence of clinical cases initiated the need for a seroprevalence and risk factors study. Two hundred and fifty-three normal horses were randomly enrolled in the study. Enrolled horses were grouped into five major regions according to the geographical proximity and climatic similarities. From each region, around 50 horses were sampled. The serum collected from each horse was screened by a competitive ELISA, and those that reacted positive using the previous ELISA test were further tested using commercial IgM-capture ELISA test. Sixty-three horses (24.9%) of the 253 surveyed were seropositive to WNV. Of the 63 horses, none had IgM antibodies for WNV. The region with the highest prevalence was Jordan Valley and Balqa. Horses used for polo (OR = 9.77; 95%CI = 1.32-25.44) and horses located in Jordan Valley and Balqa region (OR = 13.31; 95% CI = 2.33-32.54) were identified as risk factors for seropositivity to WNV in Jordan. These risk factors were attributed to the hot and humid weather, which enhance vector availability. West Nile virus appears to be endemic in Jordan. Future studies are warranted to evaluate the virus situation in the country during the next few years in an attempt to control it.

  8. Clinical decision aids for chest pain in the emergency department: identifying low-risk patients

    PubMed Central

    Alley, William; Mahler, Simon A

    2015-01-01

    Chest pain is one of the most common presenting complaints in the emergency department, though only a small minority of patients are subsequently diagnosed with acute coronary syndrome (ACS). However, missing the diagnosis has potential for significant morbidity and mortality. ACS presentations can be atypical, and their workups are often prolonged and costly. In order to risk-stratify patients and better direct the workup and care given, many decision aids have been developed. While each may have merit in certain clinical settings, the most useful aid in the emergency department is one that finds all cases of ACS while also identifying a substantial subset of patients at low risk who can be discharged without stress testing or coronary angiography. This review describes several of the chest pain decision aids developed and studied through the recent past, starting with the thrombolysis in myocardial infarction (TIMI) risk score and Global Registry of Acute Coronary Events (GRACE) scores, which were developed as prognostic aids for patients already diagnosed with ACS, then subsequently validated in the undifferentiated chest pain population. Asia-Pacific Evaluation of Chest Pain Trial (ASPECT); Accelerated Diagnostic Protocol to Assess Patients With Chest Pain Symptoms Using Contemporary Troponins (ADAPT); North American Chest Pain Rule (NACPR); and History, Electrocardiogram, Age, Risk factors, Troponin (HEART) score have been developed exclusively for use in the undifferentiated chest pain population as well, with improved performance compared to their predecessors. This review describes the relative merits and limitations of these decision aids so that providers can determine which tool fits the needs of their clinical practice setting. PMID:27147894

  9. Omega-3 fatty acids and cardiovascular disease: effects on risk factors, molecular pathways, and clinical events.

    PubMed

    Mozaffarian, Dariush; Wu, Jason H Y

    2011-11-01

    We reviewed available evidence for cardiovascular effects of n-3 polyunsaturated fatty acid (PUFA) consumption, focusing on long chain (seafood) n-3 PUFA, including their principal dietary sources, effects on physiological risk factors, potential molecular pathways and bioactive metabolites, effects on specific clinical endpoints, and existing dietary guidelines. Major dietary sources include fatty fish and other seafood. n-3 PUFA consumption lowers plasma triglycerides, resting heart rate, and blood pressure and might also improve myocardial filling and efficiency, lower inflammation, and improve vascular function. Experimental studies demonstrate direct anti-arrhythmic effects, which have been challenging to document in humans. n-3 PUFA affect a myriad of molecular pathways, including alteration of physical and chemical properties of cellular membranes, direct interaction with and modulation of membrane channels and proteins, regulation of gene expression via nuclear receptors and transcription factors, changes in eicosanoid profiles, and conversion of n-3 PUFA to bioactive metabolites. In prospective observational studies and adequately powered randomized clinical trials, benefits of n-3 PUFA seem most consistent for coronary heart disease mortality and sudden cardiac death. Potential effects on other cardiovascular outcomes are less-well-established, including conflicting evidence from observational studies and/or randomized trials for effects on nonfatal myocardial infarction, ischemic stroke, atrial fibrillation, recurrent ventricular arrhythmias, and heart failure. Research gaps include the relative importance of different physiological and molecular mechanisms, precise dose-responses of physiological and clinical effects, whether fish oil provides all the benefits of fish consumption, and clinical effects of plant-derived n-3 PUFA. Overall, current data provide strong concordant evidence that n-3 PUFA are bioactive compounds that reduce risk of cardiac

  10. Ethical, Legal, and Clinical Considerations when Disclosing a High-Risk Syndrome for Psychosis.

    PubMed

    Mittal, Vijay A; Dean, Derek J; Mittal, Jyoti; Saks, Elyn R

    2015-10-01

    There are complex considerations when planning to disclose an attenuated psychosis syndrome (APS) diagnosis. In this review, we evaluate ethical, legal, and clinical perspectives as well as caveats related to full, non- and partial disclosure strategies, discuss societal implications, and provide clinical suggestions. Each of the disclosure strategies is associated with benefits as well as costs/considerations. Full disclosure promotes autonomy, allows for the clearest psychoeducation about additional risk factors, helps to clarify and/or correct previous diagnoses/treatments, facilitates early intervention and bolsters communication between providers but there are important considerations involving heritability, comorbidity, culture, and stigma. Non-disclosure advances nonmaleficence by limiting stigma and stress (which may inadvertently exacerbate the condition), and confusion (related to the rapidly evolving diagnosis) in a sensitive developmental period but is complicated by varying patient preferences and the possibility that, as new treatments without adverse effects become available, the risk with false positives no longer justifies the accompanying loss of autonomy. Partial disclosure balances ethical considerations by focusing on symptoms instead of labels, but evidence that laypersons may interpret this information as a pseudo-diagnosis and that symptoms alone also contribute to stigma limits the efficacy of this approach. In addition, there are notable societal considerations relating to disclosure involving conservatorship, the reach of insurance companies, and discrimination. We advocate a hybrid approach to disclosure and recommend future research aimed at understanding the effects of stigma on clinical course and a renewed focus on those help-seeking cases that do not transition but remain clinically relevant.

  11. Clinical Evaluation of a Multiple-Gene Sequencing Panel for Hereditary Cancer Risk Assessment

    PubMed Central

    Kurian, Allison W.; Hare, Emily E.; Mills, Meredith A.; Kingham, Kerry E.; McPherson, Lisa; Whittemore, Alice S.; McGuire, Valerie; Ladabaum, Uri; Kobayashi, Yuya; Lincoln, Stephen E.; Cargill, Michele; Ford, James M.

    2014-01-01

    Purpose Multiple-gene sequencing is entering practice, but its clinical value is unknown. We evaluated the performance of a customized germline-DNA sequencing panel for cancer-risk assessment in a representative clinical sample. Methods Patients referred for clinical BRCA1/2 testing from 2002 to 2012 were invited to donate a research blood sample. Samples were frozen at −80° C, and DNA was extracted from them after 1 to 10 years. The entire coding region, exon-intron boundaries, and all known pathogenic variants in other regions were sequenced for 42 genes that had cancer risk associations. Potentially actionable results were disclosed to participants. Results In total, 198 women participated in the study: 174 had breast cancer and 57 carried germline BRCA1/2 mutations. BRCA1/2 analysis was fully concordant with prior testing. Sixteen pathogenic variants were identified in ATM, BLM, CDH1, CDKN2A, MUTYH, MLH1, NBN, PRSS1, and SLX4 among 141 women without BRCA1/2 mutations. Fourteen participants carried 15 pathogenic variants, warranting a possible change in care; they were invited for targeted screening recommendations, enabling early detection and removal of a tubular adenoma by colonoscopy. Participants carried an average of 2.1 variants of uncertain significance among 42 genes. Conclusion Among women testing negative for BRCA1/2 mutations, multiple-gene sequencing identified 16 potentially pathogenic mutations in other genes (11.4%; 95% CI, 7.0% to 17.7%), of which 15 (10.6%; 95% CI, 6.5% to 16.9%) prompted consideration of a change in care, enabling early detection of a precancerous colon polyp. Additional studies are required to quantify the penetrance of identified mutations and determine clinical utility. However, these results suggest that multiple-gene sequencing may benefit appropriately selected patients. PMID:24733792

  12. Design and Development of a Clinical Risk Management Tool Using Radio Frequency Identification (RFID)

    PubMed Central

    Pourasghar, Faramarz; Tabrizi, Jafar Sadegh; Yarifard, Khadijeh

    2016-01-01

    Background: Patient safety is one of the most important elements of quality of healthcare. It means preventing any harm to the patients during medical care process. Objective: This paper introduces a cost-effective tool in which the Radio Frequency Identification (RFID) technology is used to identify medical errors in hospital. Methods: The proposed clinical error management system (CEMS) is consisted of a reader device, a transfer/receiver device, a database and managing software. The reader device works using radio waves and is wireless. The reader sends and receives data to/from the database via the transfer/receiver device which is connected to the computer via USB port. The database contains data about patients’ medication orders. Results: The CEMS has the ability to identify the clinical errors before they occur and then warns the care-giver with voice and visual messages to prevent the error. This device reduces the errors and thus improves the patient safety. Conclusion: A new tool including software and hardware was developed in this study. Application of this tool in clinical settings can help the nurses prevent medical errors. It can also be a useful tool for clinical risk management. Using this device can improve the patient safety to a considerable extent and thus improve the quality of healthcare. PMID:27147802

  13. Genetic stratification in myeloid diseases: from risk assessment to clinical decision support tool.

    PubMed

    Ofran, Yishai

    2014-10-01

    Genetic aberrations have become a dominant factor in the stratification of myeloid malignancies. Cytogenetic and a few mutation studies are the backbone of risk assessment models of myeloid malignancies which are a major consideration in clinical decisions, especially patient assignment for allogeneic stem cell transplantation. Progress in our understanding of the genetic basis of the pathogenesis of myeloid malignancies and the growing capabilities of mass sequencing may add new roles for the clinical usage of genetic data. A few recently identified mutations recognized to be associated with specific diseases or clinical scenarios may soon become part of the diagnostic criteria of such conditions. Mutational studies may also advance our capabilities for a more efficient patient selection process, assigning the most effective therapy at the best timing for each patient. The clinical utility of genetic data is anticipated to advance further with the adoption of deep sequencing and next-generation sequencing techniques. We herein suggest some future potential applications of sequential genetic data to identify pending deteriorations at time points which are the best for aggressive interventions such as allogeneic stem cell transplantation. Genetics is moving from being mostly a prognostic factor to becoming a multitasking decision support tool for hematologists. Physicians must pay attention to advances in molecular hematology as it will soon be accessible and influential for most of our patients.

  14. The Dark Side of the Moon: Meta-analytical Impact of Recruitment Strategies on Risk Enrichment in the Clinical High Risk State for Psychosis

    PubMed Central

    Fusar-Poli, Paolo; Schultze-Lutter, Frauke; Cappucciati, Marco; Rutigliano, Grazia; Bonoldi, Ilaria; Stahl, Daniel; Borgwardt, Stephan; Riecher-Rössler, Anita; Addington, Jean; Perkins, Diana O.; Woods, Scott W.; McGlashan, Thomas; Lee, Jimmy; Klosterkötter, Joachim; Yung, Alison R.; McGuire, Philip

    2016-01-01

    Background: The individual risk of developing psychosis after being tested for clinical high-risk (CHR) criteria (posttest risk of psychosis) depends on the underlying risk of the disease of the population from which the person is selected (pretest risk of psychosis), and thus on recruitment strategies. Yet, the impact of recruitment strategies on pretest risk of psychosis is unknown. Methods: Meta-analysis of the pretest risk of psychosis in help-seeking patients selected to undergo CHR assessment: total transitions to psychosis over the pool of patients assessed for potential risk and deemed at risk (CHR+) or not at risk (CHR−). Recruitment strategies (number of outreach activities per study, main target of outreach campaign, and proportion of self-referrals) were the moderators examined in meta-regressions. Results: 11 independent studies met the inclusion criteria, for a total of 2519 (CHR+: n = 1359; CHR−: n = 1160) help-seeking patients undergoing CHR assessment (mean follow-up: 38 months). The overall meta-analytical pretest risk for psychosis in help-seeking patients was 15%, with high heterogeneity (95% CI: 9%–24%, I 2 = 96, P < .001). Recruitment strategies were heterogeneous and opportunistic. Heterogeneity was largely explained by intensive (n = 11, β = −.166, Q = 9.441, P = .002) outreach campaigns primarily targeting the general public (n = 11, β = −1.15, Q = 21.35, P < .001) along with higher proportions of self-referrals (n = 10, β = −.029, Q = 4.262, P = .039), which diluted pretest risk for psychosis in patients undergoing CHR assessment. Conclusions: There is meta-analytical evidence for overall risk enrichment (pretest risk for psychosis at 38monhts = 15%) in help-seeking samples selected for CHR assessment as compared to the general population (pretest risk of psychosis at 38monhts=0.1%). Intensive outreach campaigns predominantly targeting the general population and a higher proportion of self-referrals diluted the pretest risk

  15. Risk factors and clinical features of ovarian pregnancy: a case–control study

    PubMed Central

    Zhu, Qian; Li, Cheng; Zhao, Wei-Hong; Yuan, Jiang-Jing; Yan, Ming-Xing; Qin, Guo-Juan; Zhang, Jian

    2014-01-01

    Objective To identify risk factors for ovarian pregnancy (OP) and compare clinical features between OP and tubal pregnancy (TP) patients. Design Case–control study. Setting University hospital. Participants A case–control study was conducted from January 2005 to May 2014. Women diagnosed with OP were recruited as the case group (n=71), 145 women with TP and 146 with intrauterine pregnancy (IUP) were matched as controls at a ratio of 1:2:2. Women who refused interviews or provided incomplete information were excluded. Results OP risk was lower than TP risk in women with serological evidence of Chlamydia trachomatis infection (adjusted OR1 0.17, 95% CI 0.06 to 0.52), previous adnexal surgery (adjusted OR1 0.25, 95% CI 0.07 to 0.95), and current levonorgestrel emergency contraceptive use (adjusted OR1 0.24, 95% CI 0.07 to 0.78). In vitro fertilisation-embryo transfer (IVF-ET) carried a higher risk of OP (adjusted OR1 12.18, 95% CI 2.23 to 66.58) than natural conception. When Controlled by IUP women, current users of intrauterine devices (IUDs) carried a higher risk of OP than non-users of any contraceptives (adjusted OR2 9.60, 95% CI 1.76 to 42.20). β-Human chorionic gonadotropin (hCG) levels on the day of surgery were higher in OP patients than in TP patients (p<0.01). Women with OP were less likely to initially present with vaginal bleeding than those with TP (p=0.02). Moreover, shock (p=0.02), rupture (p<0.01), haemoperitoneum (p<0.01) and emergency laparotomy (p<0.01) were more common in the OP group than in the TP group. Conclusions IVF-ET and IUD use may be risk factors for OP, and OP patients tend to have high β-hCG levels and a poor clinical outcome (shock, rupture, haemoperitoneum and need for emergency laparotomy). Our findings may contribute to the prevention and early diagnosis of OP. PMID:25472658

  16. Baseline risk as predictor of treatment benefit: three clinical meta-re-analyses.

    PubMed

    Arends, L R; Hoes, A W; Lubsen, J; Grobbee, D E; Stijnen, T

    2000-12-30

    A relationship between baseline risk and treatment effect is increasingly investigated as a possible explanation of between-study heterogeneity in clinical trial meta-analysis. An approach that is still often applied in the medical literature is to plot the estimated treatment effects against the estimated measures of risk in the control groups (as a measure of baseline risk), and to compute the ordinary weighted least squares regression line. However, it has been pointed out by several authors that this approach can be seriously flawed. The main problem is that the observed treatment effect and baseline risk measures should be viewed as estimates rather than the true values. In recent years several methods have been proposed in the statistical literature to potentially deal with the measurement errors in the estimates. In this article we propose a vague priors Bayesian solution to the problem which can be carried out using the 'Bayesian inference using Gibbs sampling' (BUGS) implementation of Markov chain Monte Carlo numerical integration techniques. Different from other proposed methods, it uses the exact rather than an approximate likelihood, while it can handle many different treatment effect measures and baseline risk measures. The method differs from a recently proposed Bayesian method in that it explicitly models the distribution of the underlying baseline risks. We apply the method to three meta-analyses published in the medical literature and compare the results with the outcomes of the other recently proposed methods. In particular we compare our approach to McIntosh's method, for which we show how it can be carried out using standard statistical software. We conclude that our proposed method offers a very general and flexible solution to the problem, which can be carried out relatively easily with existing Bayesian analysis software. A confidence band for the underlying relationship between true effect measure and baseline risk and a confidence interval

  17. ASSOCIATION BETWEEN URINARY MUTAGENICITY AND RISK OF COLORECTAL ADENOMAS IN A CLINIC-BASED CASE-CONTROL STUDY

    EPA Science Inventory

    ASSOCIATION BETWEEN URINARY MUTAGENICITY AND RISK OF COLORECTAL ADENOMAS IN A CLINIC-BASED CASE-CONTROL STUDY

    Humans are exposed to a variety of mutagens from diet, smoking, or occupation. To explore if exposure to mutagens was related to the risk of colorectal adenomas i...

  18. Childhood Sexual Abuse and Sexual Risk Behavior among Men and Women Attending a Sexually Transmitted Disease Clinic

    ERIC Educational Resources Information Center

    Senn, Theresa E.; Carey, Michael P.; Vanable, Peter A.; Coury-Doniger, Patricia; Urban, Marguerite A.

    2006-01-01

    Childhood sexual abuse (CSA) is associated with a wide range of negative outcomes. The authors investigated the relation between CSA and sexual risk behavior in 827 patients recruited from a sexually transmitted disease (STD) clinic. Overall, CSA was reported by 53% of women and 49% of men and was associated with greater sexual risk behavior,…

  19. 78 FR 48173 - Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Investigations--A Risk-Based Approach to Monitoring; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Oversight of Clinical Investigations--A Risk-Based Approach to...

  20. Long-term adoption of caries management by risk assessment among dental students in a university clinic.

    PubMed

    Chaffee, Benjamin W; Featherstone, John D B

    2015-05-01

    The aim of this study was to evaluate the long-term adoption of a risk-based caries management program at a university dental clinic. The authors extracted data from electronic records of adult non-edentulous patients who underwent a comprehensive oral evaluation in the university predoctoral clinic from July 2007 through June 2014 (N=21,984). Consistency with caries management guidelines was measured as the percentage of patients with caries risk designation (low, moderate, high, or extreme) and the percentage of patients provided non-operative anti-caries agents within each designated caries risk category. Additionally, patient and provider characteristics associated with risk assessment completion and with provision of anti-caries therapy were identified. Results showed that the percentage of patients with documented caries risk grew steadily from 62.3% in 2007-08 to 92.8% in 2013-14. Overall, receipt of non-operative anti-caries agents increased with rising caries risk, from low (6.9%), moderate (14.1%), high (36.4%), to extreme (51.4%), but percentages were stable over the study period. Younger patients were more likely to have a completed risk assessment, and among high- and extreme-risk patients, delivery of anti-caries therapy was more common among patients who were younger, identified as Asian or Caucasian, received public dental benefits, or were seen by a student in the four-year DDS program or in the final year of training. These results demonstrate that extensive compliance in documenting caries risk was achieved within a decade of implementing risk-based clinical guidelines at this dental school clinic. Caries risk was the most strongly associated of several factors related to delivery of non-operative therapy. The eventual success of this program suggests that, in dental education, transition to a risk-based, prevention-focused curriculum may require a long-term commitment.

  1. Discordance between ambulatory versus clinic blood pressure according to global cardiovascular risk group

    PubMed Central

    Shin, Jinho; Park, Sung Ha; Kim, Ju Han; Ihm, Sang Hyun; Kim, Kwang-il; Kim, Woo Shik; Pyun, Wook Bum; Kim, Yu-Mi; Choi, Sung-il; Kim, Soon Kil

    2015-01-01

    Background/Aims: The detection of white coat hypertension (WCH), treated normalized hypertension, and masked hypertension (MH) is important to improve the effectiveness of hypertension management. However, whether global cardiovascular risk (GCR) profile has any effect on the discordance between ambulatory blood pressure (ABP) and clinic blood pressure (CBP) is unknown. Methods: Data from 1,916 subjects, taken from the Korean Multicenter Registry for ABP monitoring, were grouped according to diagnostic and therapeutic thresholds for CBP and ABP (140/90 and 135/85 mmHg, respectively). GCR was assessed using European Society of Hypertension 2007 guidelines. Results: The mean subject age was 54.1 ± 14.9 years, and 48.9% of patients were female. The discordancy rate between ABP and CBP in the untreated and treated patients was 32.5% and 26.5%, respectively (p = 0.02). The prevalence of WCH or treated normalized hypertension and MH was 14.4% and 16.0%, respectively. Discordance between ABP and CBP was lower in the very high added-risk group compared to the moderate added-risk group (odds ratio [OR], 0.649; 95% confidence interval [CI], 0.487 to 0.863; p = 0.003). The prevalence of WCH or treated normalized hypertension was also lower in the very high added-risk group (OR, 0.451; 95% CI, 0.311 to 0.655). Conclusions: Discordance between ABP and CBP was observed more frequently in untreated subjects than in treated subjects, and less frequently in the very high added-risk group, which was due mainly to the lower prevalence of WCH or treated normalized hypertension. PMID:26354055

  2. Phenobarbitone-induced haematological abnormalities in idiopathic epileptic dogs: prevalence, risk factors, clinical presentation and outcome.

    PubMed

    Bersan, E; Volk, H A; Ros, C; De Risio, L

    2014-09-13

    The aim of this retrospective study was to assess prevalence, risk factors, clinical presentation and outcome of phenobarbitone induced haematological abnormalities (PBIHA) in dogs. The medical records of two veterinary referral institutions were searched for dogs diagnosed with idiopathic epilepsy and treated with PB as monotherapy or polytherapy between March 2003 and September 2010. Sixteen dogs had PBIHA; the median age at diagnosis was 69.5 months. Phenobarbitone was administered at a median dose of 3 mg/kg twice a day for a median period of 100.5 days and the median serum phenobarbitone level was 19 μg/ml. Two dogs had neutropenia, three had anaemia and thrombocytopenia, two had anaemia and neutropenia; the remaining nine had pancytopenia. All dogs were referred for non-specific clinical signs. Phenobarbitone was discontinued after diagnosis, and the median time to resolution of PBIHA was 17 days. The prevalence and risk factors for PBIHA were evaluated from a questionnaire survey of referring practices to obtain more detailed follow-up on cases diagnosed with idiopathic epilepsy. The prevalence rate of PBIHA was 4.2%, and the condition occurred in dogs treated with standard therapeutic doses often within the first three months after starting treatment. Serial haematological evaluations should be therefore considered from the beginning of phenobarbitone therapy to allow early diagnosis and treatment of PBIHA.

  3. Assessing depression in youth at clinical high risk for psychosis: a comparison of three measures

    PubMed Central

    DeVylder, Jordan; Yang, Lawrence; Harkavy-Friedman, Jill; Azimov, Neyra; Walder, Deborah; Corcoran, Cheryl

    2014-01-01

    Depressive symptoms are prevalent among individuals at clinical high-risk (CHR) for psychosis. Prior studies have used the Beck Depression Inventory (BDI), Hamilton Depression Rating Scale (HDRS), and the “dysphoric mood” item of the Scale of Prodromal Symptoms (SOPS) to assess depressive symptoms in CHR samples. We compared the psychometric properties of these instruments in a CHR cohort, to support the selection of appropriate depressive symptoms measures in future studies and in clinical settings. Internal consistency was assessed using Cronbach’s alpha. Construct validity was assessed through correlations with SOPS items that were expected or not expected to be related to depressive symptoms. Criterion validity was assessed by comparing scores between patients with and without a major depressive disorder diagnosis. We hypothesized based on the schizophrenia literature that the BDI would have superior internal consistency and discriminant validity compared to the HDRS, and that all three measures would show convergent validity and criterion validity. The BDI demonstrated superior internal consistency and construct validity in this at-risk sample. The BDI and HDRS differentiated patients with major depressive disorder, but SOPS dysphoria did not. This has implications for the choice of depression measures in future CHR studies and for the interpretation of past findings. PMID:24370335

  4. Visible aging signs as risk markers for ischemic heart disease: Epidemiology, pathogenesis and clinical implications.

    PubMed

    Christoffersen, Mette; Tybjærg-Hansen, Anne

    2016-01-01

    Association of common aging signs (i.e., male pattern baldness, hair graying, and facial wrinkles) as well as other age-related appearance factors (i.e., arcus corneae, xanthelasmata, and earlobe crease) with increased risk of ischemic heart disease was initially described in anecdotal reports from clinicians observing trends in the physical appearance of patients with ischemic heart disease. Following these early observations numerous epidemiological studies have reported these associations. Since the prevalences of both visible aging signs and ischemic heart disease have a strong correlation with increasing age, it has been extensively debated whether the observed associations could be entirely explained by a common association with age. Furthermore, the etiologies of the visible aging signs are rarely fully understood, and pathophysiological explanations for these associations remain controversial, and are mostly speculative. As a consequence of inconsistent findings and lack of mechanistic explanations for the observed associations with ischemic heart disease, consensus on the clinical importance of these visible aging signs has been lacking. The aim of this review is for each of the visible aging signs to (i) review the etiology, (ii) to discuss the current epidemiological evidence for an association with risk of ischemic heart disease, and (iii) to present possible pathophysiological explanations for these associations. Finally this review discusses the potential clinical implications of these findings.

  5. Strongyloidiasis: prevalence, risk factors, clinical and laboratory features among diarrhea patients in Ibadan Nigeria.

    PubMed

    Dada-Adegbola, H O; Oluwatoba, O A; Bakare, R A

    2010-12-01

    Strongyloidiasis is a parasitic infection caused by Strongyloides stercoralis. The infection is usually mild or asymptomatic in normal immunocompetent individuals, but could be very severe or even fatal due to hyper infection in individuals who are immunosuppressed. This study aimed at determining the prevalence, risk factors and features of strongyloidiasis among diarrhea patients in Ibadan. This is a descriptive cross-sectional study of diarrhea patients from a teaching hospital, three major government hospitals and one mission hospital in Ibadan. Self administered questionnaire, clinical assessment and laboratory investigations were used to confirm health status and presence of S. stercoralis. Diagnosis was made by microscopic examination of stool in saline preparation and formol-ether concentration. One thousand and ninety patients, (562 (51.6%) males and 528 (48.4%) females) consisting 380 (34.9%) children and 710 (65.1%) adults who had diarrhea were studied. The prevalence rate for the parasite among diarrhea patients was 3.0%. While the risk factor for infection remains contact with contaminated soil, malnutrition, steroid therapy, HIV/AIDS, lymphomas, tuberculosis, and chronic renal failure. Others are maleness, institutionalism and alcoholism. Predominant clinical presentations are abdominal pain, chronic diarrhea, and bloating and weight loss, Strongyloides stercoralis should be considered in diarrhea patients who are either malnourished or immunosuppressed.

  6. LUNG CANCER IN NEVER SMOKERS: CLINICAL EPIDEMIOLOGY AND ENVIRONMENTAL RISK FACTORS

    PubMed Central

    Samet, Jonathan M.; Avila-Tang, Erika; Boffetta, Paolo; Hannan, Lindsay M.; Olivo-Marston, Susan; Thun, Michael J.; Rudin, Charles M.

    2011-01-01

    More than 161,000 lung cancer deaths are projected to occur in the U.S. in 2008. Of these, an estimated 10–15% will be caused by factors other than active smoking, corresponding to 16,000–24,000 deaths annually. Thus lung cancer in never smokers would rank among the most common causes of cancer mortality in the U.S. if considered to be a separate category. Slightly more than half of the lung cancers caused by factors other than active smoking occur in never smokers. As summarized in the accompanying article, lung cancers that occur in never smokers differ from those that occur in smokers in their molecular profile and response to targeted therapy. These recent laboratory and clinical observations highlight the importance of defining the genetic and environmental factors responsible for the development of lung cancer in never-smokers. This article summarizes available data on the clinical epidemiology of lung cancer in never smokers, and the several environmental risk factors that population-based research has implicated in the etiology of these cancers. Primary factors closely tied to lung cancer in never smokers include exposure to known and suspected carcinogens including radon, second-hand tobacco smoke, and other indoor air pollutants. Several other exposures have been implicated. However, a large fraction of lung cancers occurring in never-smokers cannot be definitively associated with established environmental risk factors, highlighting the need for additional epidemiologic research in this area. PMID:19755391

  7. Study of Clinical and Genetic Risk Factors for Aspirin-induced Gastric Mucosal Injury

    PubMed Central

    Wu, Yun; Hu, Ying; You, Peng; Chi, Yu-Jing; Zhou, Jian-Hua; Zhang, Yuan-Yuan; Liu, Yu-Lan

    2016-01-01

    Background: Current knowledge about clinical and genetic risk factors for aspirin-induced gastric mucosal injury is not sufficient to prevent these gastric mucosal lesions. Methods: We recruited aspirin takers as the exposed group and healthy volunteers as the control group. The exposed group was categorized into two subgroups such as subgroup A as gastric mucosal injury diagnosed by gastroscopy, including erosion, ulcer or bleeding of the esophagus, stomach, or duodenum; subgroup B as no injury of the gastric mucosa was detected by gastroscopy. Clinical information was collected, and 53 single nucleotide polymorphisms were evaluated. Results: Among 385 participants, 234 were in the aspirin-exposed group. According to gastroscopy, 82 belonged to subgroup A, 91 belonged to subgroup B, and gastroscopic results of 61 participants were not available. Using the Chi-square test and logistic regression, we found that peptic ulcer history (odds ratio [OR] = 5.924, 95% confidence intervals [CI]: 2.115–16.592), dual anti-platelet medication (OR = 3.443, 95% CI: 1.154–10.271), current Helicobacter pylori infection (OR = 2.242, 95% CI: 1.032–4.870), male gender (OR = 2.211, 95% CI: 1.027–4.760), GG genotype of rs2243086 (OR = 4.516, 95% CI: 1.180–17.278), and AA genotype of rs1330344 (OR = 2.178, 95% CI: 1.016–4.669) were more frequent in subgroup A than subgroup B. In aspirin users who suffered from upper gastrointestinal bleeding, the frequency of the TT genotype of rs2238631 and TT genotype of rs2243100 was higher than in those without upper gastrointestinal bleeding. Conclusions: Peptic ulcer history, dual anti-platelet medication, H. pylori current infection, and male gender were possible clinical risk factors for aspirin-induced gastric mucosal injury. GG genotype of rs2243086 and AA genotype of rs1330344 were possible genetic risk factors. TT genotype of rs2238631 and TT genotype of rs2243100 may be risk factors for upper gastrointestinal bleeding in aspirin

  8. Prime Time: 12-Month Sexual Health Outcomes of a Clinic-Based Intervention to Prevent Pregnancy Risk Behaviors

    PubMed Central

    Sieving, Renee E.; McMorris, Barbara J.; Beckman, Kara J.; Pettingell, Sandra L.; Secor-Turner, Molly; Kugler, Kari; Garwick, Ann W.; Resnick, Michael D.; Bearinger, Linda H.

    2010-01-01

    Purpose Prime Time, a youth development intervention, aims to reduce pregnancy risk among adolescent girls seeking clinic services who are at high risk for pregnancy. This paper examines sexual risk behaviors and hypothesized psychosocial mediators after 12 months of the Prime Time intervention. Methods Randomized controlled trial with 253 girls ages 13-17 years meeting specified risk criteria. Intervention participants were involved in Prime Time programming plus usual clinic services for 18 months, control participants received usual clinic services. The intervention employed a combination of case management and peer leadership programs. Participants in this interim outcomes study completed self-report surveys at baseline and 12 months following enrollment. Surveys assessed sexual risk behaviors and psychosocial factors targeted for change by Prime Time. Results At the 12-month interim, the intervention group reported more consistent use of condoms, hormonal contraception and dual contraceptive methods with their most recent partner than did the control group. The intervention group also reported greater stress management skills with trends towards higher levels of pro-social connectedness at school and with family. No between-group differences were noted in psychosocial measures specific to sex and contraceptive use. Conclusions Preventing early pregnancy among high-risk adolescents requires multifaceted, sustained approaches. An important research focus involves testing youth development interventions offered through clinic settings, where access to high-risk adolescents is plentiful and few efforts have emphasized a dual approach of building protective factors while addressing risk. Findings suggest that youth development interventions through clinic settings hold promise in reducing pregnancy risk among high-risk youth. PMID:21783050

  9. Tobacco use and health risks in two dental clinic populations: Implementation and evaluation of a brief targeted intervention.

    PubMed

    Romito, Laura; Budyn, Cynthia; Oklak, Mark A; Gotlib, Josh; Eckert, George J

    2012-01-01

    The present study compared emergency dental clinic and hygiene clinic patients in terms of tobacco use and health risks, and began and evaluated an Ask/Advise/Refer intervention in the emergency clinic. Randomly selected records (N = 820) of patients from both clinics were reviewed and demographics, tobacco, and health data were recorded and analyzed. After a brief training period, student dentists delivered a five-week emergency clinic tobacco intervention and completed a post-intervention evaluation survey. Tobacco use was higher in the emergency clinic and was correlated with systemic and oral disease. Of the 327 emergency clinic patients seen during the pilot study, 50% were smokers, 46% of whom expressed an interested in quitting and 35% of whom obtained cessation referral. Thirty students (86%) completed the evaluation; perceptions of the intervention were neutral to favorable. The emergency clinic Ask/Advise/Refer intervention was well-received by patients and clinicians.

  10. Clinical features, risk factors, and outcome of cerebral venous thrombosis in Tehran, Iran

    PubMed Central

    Yadegari, Samira; Ghorbani, Askar; Miri, S. Roohollah; Abdollahi, Mohammad; Rostami, Mohsen

    2016-01-01

    Introduction: Despite increasing the use of magnetic resonance imaging (MRI), cerebral venous sinus thrombosis (CVST) has remained an under-diagnosed condition. In this study, characteristics and frequency of various risk factors of CVST patients in a tertiary referral hospital were closely assessed. Methods: Patients with an unequivocal diagnosis of CVST confirmed by MRI and magnetic resonance venography during 6 years of the study were included. All data from the onset of symptoms regarding clinical signs and symptoms, hospital admission, seasonal distribution, medical and drug history, thrombophilic profile, D-dimer, neuroimaging, cerebrospinal fluid findings, mortality, and outcome were collected and closely analyzed. Result: A total of 53 patients with female to male ratio of 3.07 and mean age of 33.7 years were included in the study. Headache and papilledema were the most frequent clinical features (44 and 36 patients, respectively). An underlying disease (diagnosed previously or after admission) was the most common identified risk factor for CVST in both females and males (21 patients). A total of 15 women used the oral contraceptive pill (OCP) where 12 of them had simultaneously other predisposing factors. Overall, 19 patients (36%) had more than one contributing factor. D-dimer had a sensitivity of 71.4% in CVST patients. The mortality of patients in this study was 3.7% (n = 2). Focal neurologic deficit and multicranial nerve palsy were associated with poor outcome which defined as death, recurrence, and massive intracranial hemorrhage due to anticoagulation (P = 0.050 and 0.004, respectively). Conclusion: Unlike most of the CVST studies in which OCP was the main factor; in this study, an underlying disease was the most identified cause. Considering the high probability of multiple risk factors in CVST that was shown by this study, appropriate work up should be noted to uncover them.

  11. Clinical features, risk factors, and outcome of cerebral venous thrombosis in Tehran, Iran

    PubMed Central

    Yadegari, Samira; Ghorbani, Askar; Miri, S. Roohollah; Abdollahi, Mohammad; Rostami, Mohsen

    2016-01-01

    Introduction: Despite increasing the use of magnetic resonance imaging (MRI), cerebral venous sinus thrombosis (CVST) has remained an under-diagnosed condition. In this study, characteristics and frequency of various risk factors of CVST patients in a tertiary referral hospital were closely assessed. Methods: Patients with an unequivocal diagnosis of CVST confirmed by MRI and magnetic resonance venography during 6 years of the study were included. All data from the onset of symptoms regarding clinical signs and symptoms, hospital admission, seasonal distribution, medical and drug history, thrombophilic profile, D-dimer, neuroimaging, cerebrospinal fluid findings, mortality, and outcome were collected and closely analyzed. Result: A total of 53 patients with female to male ratio of 3.07 and mean age of 33.7 years were included in the study. Headache and papilledema were the most frequent clinical features (44 and 36 patients, respectively). An underlying disease (diagnosed previously or after admission) was the most common identified risk factor for CVST in both females and males (21 patients). A total of 15 women used the oral contraceptive pill (OCP) where 12 of them had simultaneously other predisposing factors. Overall, 19 patients (36%) had more than one contributing factor. D-dimer had a sensitivity of 71.4% in CVST patients. The mortality of patients in this study was 3.7% (n = 2). Focal neurologic deficit and multicranial nerve palsy were associated with poor outcome which defined as death, recurrence, and massive intracranial hemorrhage due to anticoagulation (P = 0.050 and 0.004, respectively). Conclusion: Unlike most of the CVST studies in which OCP was the main factor; in this study, an underlying disease was the most identified cause. Considering the high probability of multiple risk factors in CVST that was shown by this study, appropriate work up should be noted to uncover them. PMID:27695236

  12. Liver Abscess Formation Following Transarterial Chemoembolization: Clinical Features, Risk Factors, Bacteria Spectrum, and Percutaneous Catheter Drainage.

    PubMed

    Lv, Wei-Fu; Lu, Dong; He, Yu-Sheng; Xiao, Jing-Kun; Zhou, Chun-Ze; Cheng, De-Lei

    2016-04-01

    To investigate the clinical features, risk factors, and bacterial spectrum of liver abscess following transarterial chemoembolization (TACE) and evaluate the therapeutic effect of percutaneous catheter drainage (PCD) on the abscesses.A retrospective review of patient charts was performed in 3613 patients who suffered from liver malignancies (2832 patients with hepatocellular carcinoma and 781 with metastatic hepatic tumor) and had undergone 11,054 TACE procedures from January 2005 to October 2013. Liver abscesses were found in 21 patients. PCD was performed in all abscess patients. The clinical features, risk factors, and bacterial spectrum of liver abscess following TACE were investigated and the therapeutic effect of PCD was evaluated.The incidence of liver abscess was 0.58% per patient and 0.19% per procedure. Approximately 57.1% of the patients had a medical history of bilioenteric anastomosis or biliary stent implantation. On computed tomography scans, the abscesses appeared as low-attenuation lesions and high-density iodinate oil scattered in the abscesses. The ultrasound showed the well defined, heterogeneously hypoechoic lesions. Positive microbiological isolates were obtained in all pus cultures and in 47.6% of blood cultures. The most common bacterium was Escherichia coli (52.4%). Twenty patients (95.2%) were cured from abscesses by using PCD, and 1 died of sepsis.Patients with predisposing factors are prone to an increased risk of liver abscess following TACE. Bacterial culture and antibiotic sensitivity tests on pus and blood help on the antibiotics selection. PCD combined with aggressive antibiotics can be recommended as the first-line therapeutic regimen. PMID:27124055

  13. Clinical characteristics and risk factors of periprosthetic femoral fractures associated with hip arthroplasty: A retrospective study.

    PubMed

    Zhang, Zhendong; Zhuo, Qi; Chai, Wei; Ni, Ming; Li, Heng; Chen, Jiying

    2016-08-01

    Periprosthetic femoral fracture (PFF) is a complicated complication of both primary and revision hip arthroplasty with an increasing incidence. The present study aimed to summarize the clinical characteristics and identify the risk factors for PFF which would be potentially helpful in the prevention and treatment of PFF.We retrospectively analyzed the clinical data of 89 cases of PFF, and a case-control study was designed to identify the potential risk for intraoperative and postoperative PFF in both primary and revision hip arthroplasty.The overall incidence of PFF was 2.08% (intraoperative: 1.77%, postoperative: 0.30%, revision: 13.60%, and primary: 0.97%). The most commonly used treatment strategy was fixation with cerclage wire or band for intraoperative PFF, whereas long stem revision with plate or cortical allograft strut fixation was the main treatment strategy for postoperative PFF. The risk factors for intraoperative PFF in primary total hip arthroplasty (THA) included the diagnosis of development dysplasia of the hip (DDH) (odds ratio [OR] = 5.01, 95%CI, 1.218-20.563, P=0.03) and CBR ≥ 0.49 (OR = 3.34, 95%CI, 1.138-9.784, P = 0.03). The increased age was associated with increased incidence of postoperative PFF in primary THA (OR = 1.09, 95%CI, 1.001-1.194, P = 0.04). As for the intraoperative PFF in revision THA, we found that receiving multiple operations before revision (OR = 2.45, 95%CI, 1.06-5.66, P = 0.04), revisions due to prosthetic joint infection (OR = 6.72, 95%CI, 1.007-44.832, P = 0.04), the presence of cementless implant before revision (OR = 13.54, 95%CI, 3.103-59.08, P = 0.001), and femoral deformity (OR = 8.03, 95%CI, 1.656-38.966, P = 0.01) were all risk factors.Screening for high-risk patients, preoperative templating, and detailed discharge instructions may be the potential strategies to reduce the incidence of PFF. The treatment of PFFs should take into account Vancouver

  14. Clinical characteristics and risk factors of periprosthetic femoral fractures associated with hip arthroplasty

    PubMed Central

    Zhang, Zhendong; Zhuo, Qi; Chai, Wei; Ni, Ming; Li, Heng; Chen, Jiying

    2016-01-01

    Abstract Periprosthetic femoral fracture (PFF) is a complicated complication of both primary and revision hip arthroplasty with an increasing incidence. The present study aimed to summarize the clinical characteristics and identify the risk factors for PFF which would be potentially helpful in the prevention and treatment of PFF. We retrospectively analyzed the clinical data of 89 cases of PFF, and a case–control study was designed to identify the potential risk for intraoperative and postoperative PFF in both primary and revision hip arthroplasty. The overall incidence of PFF was 2.08% (intraoperative: 1.77%, postoperative: 0.30%, revision: 13.60%, and primary: 0.97%). The most commonly used treatment strategy was fixation with cerclage wire or band for intraoperative PFF, whereas long stem revision with plate or cortical allograft strut fixation was the main treatment strategy for postoperative PFF. The risk factors for intraoperative PFF in primary total hip arthroplasty (THA) included the diagnosis of development dysplasia of the hip (DDH) (odds ratio [OR] = 5.01, 95%CI, 1.218–20.563, P=0.03) and CBR ≥ 0.49 (OR = 3.34, 95%CI, 1.138–9.784, P = 0.03). The increased age was associated with increased incidence of postoperative PFF in primary THA (OR = 1.09, 95%CI, 1.001–1.194, P = 0.04). As for the intraoperative PFF in revision THA, we found that receiving multiple operations before revision (OR = 2.45, 95%CI, 1.06–5.66, P = 0.04), revisions due to prosthetic joint infection (OR = 6.72, 95%CI, 1.007–44.832, P = 0.04), the presence of cementless implant before revision (OR = 13.54, 95%CI, 3.103–59.08, P = 0.001), and femoral deformity (OR = 8.03, 95%CI, 1.656–38.966, P = 0.01) were all risk factors. Screening for high-risk patients, preoperative templating, and detailed discharge instructions may be the potential strategies to reduce the incidence of PFF. The treatment of PFFs should take

  15. Gender Differences in Risk Factors for Stice's Bulimia in a Non-Clinical Sample.

    PubMed

    Ruisoto, Pablo; Cacho, Raúl; López-Goñi, José J; Real Deus, Eulogio; Vaca, Silvia; Mayoral, Paula

    2015-01-01

    Some females are at an increased risk of developing bulimia. However, etiological factors and their interplay remain controversial. The present study analyzed Sticefe Model for eating disorders in a non-clinical population by examining gender differences with respect to the following risk factors: body mass index (BMI), body dissatisfaction, perceived social pressure to be thin, body-thin internalization, and dieting behavior. A sample of 162 American college students (64 males and 91 females) was surveyed, and validated scales were used. The Sticey model was tested using Structural Equation Modeling. Our results supported Stice r Dual Pathway Model of bulimic pathology for females but not for males. Females reported significantly higher body dissatisfaction, perceived pressure to be thin and weight-loss oriented behaviors than males (p .05), a key predictor of body dissatisfaction (r = .33; p .05) although their BMI was significantly lower than males (d = 0,51). The results of this study fail to support the role of BMI as a predictor of dietary restraint in females, the main risk factor of eating disorders. Males may abstain from dietary restraint to gain muscular volume and in turn increase their BMI. Implications are discussed. PMID:26388326

  16. Risk Behaviors by Type of Concurrency among Young People in Three US STD Clinics

    PubMed Central

    Hess, Kristen L.; Gorbach, Pamina M.; Manhart, Lisa E.; Stoner, Bradley P.; Martin, David H.; Holmes, King K.

    2014-01-01

    Background Concurrent sexual partnerships can increase sexually transmitted diseases (STD) transmission on a population level. However, different concurrency types may be associated with differential risk for transmission. To investigate this, we describe the prevalence and correlates of four specific concurrency types. Methods Between 2001 and 2004, 1098 young adults attending 3 STD clinics were interviewed and tested for STDs. Characteristics associated with concurrency types were identified using logistic regression. Results Approximately one-third of respondents reported reactive (34%), transitional (36%), compensatory (32%), and experimental (26%) concurrency. Among men, reactive concurrency was associated with not identifying as heterosexual, drug use, and having sex the same day as meeting a partner. Among women, reactive concurrency was associated with African American race and having >3 lifetime partners. Transitional concurrency was associated with >3 lifetime partners for men and women. Among men, compensatory was associated with African American race; whereas, among women there were no associations with compensatory concurrency. Among men, experimental concurrency was associated with >3 lifetime partners and having sex the same day as meeting a partner. Among women, experimental concurrency was associated with not identifying as heterosexual, drug use, and having sex the same day as meeting a partner. Conclusions All concurrency types were common in this population and each was associated with a set of demographic and risk factors. Reactive and experimental concurrency types were associated with other high-risk behaviors, such as drug use. PMID:22697146

  17. Genetic basis of Cowden syndrome and its implications for clinical practice and risk management.

    PubMed

    Gammon, Amanda; Jasperson, Kory; Champine, Marjan

    2016-01-01

    Cowden syndrome (CS) is an often difficult to recognize hereditary cancer predisposition syndrome caused by mutations in phosphatase and tensin homolog deleted on chromosome 10 (PTEN). In addition to conferring increased cancer risks, CS also predisposes individuals to developing hamartomatous growths in many areas of the body. Due to the rarity of CS, estimates vary on the penetrance of certain phenotypic features, such as macrocephaly and skin findings (trichilemmomas, mucocutaneous papules), as well as the conferred lifetime cancer risks. To address this variability, separate clinical diagnostic criteria and PTEN testing guidelines have been created to assist clinicians in the diagnosis of CS. As knowledge of CS increases, making larger studies of affected patients possible, these criteria continue to be refined. Similarly, the management guidelines for cancer screening and risk reduction in patients with CS continue to be updated. This review will summarize the current literature on CS to assist clinicians in staying abreast of recent advances in CS knowledge, diagnostic approaches, and management. PMID:27471403

  18. [Clinical guideline for management of patients with low risk differentiated thyroid carcinoma].

    PubMed

    Díez, Juan José; Oleaga, Amelia; Álvarez-Escolá, Cristina; Martín, Tomás; Galofré, Juan Carlos

    2015-01-01

    Incidence of thyroid cancer is increasing in Spain and worldwide. Overall thyroid cancer survival is very high, and stratification systems to reliably identify patients with worse prognosis have been developed. However, marked differences exist between the different specialists in clinical management of low-risk patients with thyroid carcinoma. Almost half of all papillary thyroid carcinomas are microcarcinomas, and 90% are tumors < 2 cm that have a particularly good prognosis. However, they are usually treated more aggressively than needed, despite the lack of adequate scientific support. Surgery remains the gold standard treatment for these tumors. However, lobectomy may be adequate in most patients, without the need for total thyroidectomy. Similarly, prophylactic lymph node dissection of the central compartment is not required in most cases. This more conservative approach prevents postoperative complications such as hypoparathyroidism or recurrent laryngeal nerve injury. Postoperative radioiodine remnant ablation and strict suppression of serum thyrotropin, although effective for the more aggressive forms of thyroid cancer, have not been shown to be beneficial for the treatment of low risk patients, and may impair their quality of life. This guideline provides recommendations from the task force on thyroid cancer of the Spanish Society of Endocrinology and Nutrition for adequate management of patients with low-risk thyroid cancer.

  19. Gender Differences in Risk Factors for Stice's Bulimia in a Non-Clinical Sample.

    PubMed

    Ruisoto, Pablo; Cacho, Raúl; López-Goñi, José J; Real Deus, Eulogio; Vaca, Silvia; Mayoral, Paula

    2015-09-21

    Some females are at an increased risk of developing bulimia. However, etiological factors and their interplay remain controversial. The present study analyzed Sticefe Model for eating disorders in a non-clinical population by examining gender differences with respect to the following risk factors: body mass index (BMI), body dissatisfaction, perceived social pressure to be thin, body-thin internalization, and dieting behavior. A sample of 162 American college students (64 males and 91 females) was surveyed, and validated scales were used. The Sticey model was tested using Structural Equation Modeling. Our results supported Stice r Dual Pathway Model of bulimic pathology for females but not for males. Females reported significantly higher body dissatisfaction, perceived pressure to be thin and weight-loss oriented behaviors than males (p .05), a key predictor of body dissatisfaction (r = .33; p .05) although their BMI was significantly lower than males (d = 0,51). The results of this study fail to support the role of BMI as a predictor of dietary restraint in females, the main risk factor of eating disorders. Males may abstain from dietary restraint to gain muscular volume and in turn increase their BMI. Implications are discussed.

  20. Reducing Cardiovascular and Cancer Risk: How to Address Global Primary Prevention in Clinical Practice.

    PubMed

    Battistoni, Allegra; Mastromarino, Vittoria; Volpe, Massimo

    2015-06-01

    Emerging evidence suggesting the possibility that interventions able to prevent cardiovascular disease (CVD) may also be effective in the prevention of cancer have recently stimulated great interest in the medical community. In particular, data from both experimental and observational studies have demonstrated that aspirin may play a role in preventing different types of cancer. Although the use of aspirin in the secondary prevention of CVD is well established, aspirin in primary prevention is not systematically recommended because the absolute cardiovascular event reduction is similar to the absolute excess in major bleedings. By adding to its cardiovascular prevention benefits, the potential beneficial effect of aspirin in reducing the incidence of mortality and cancer could tip the balance between risks and benefits of aspirin therapy in primary prevention in favor of the latter and broaden the indication for treatment with aspirin in populations at average risk. Prospective and randomized studies are currently investigating the effect of aspirin in prevention of both cancer and CVD; however, clinical efforts at the individual level to promote the use of aspirin in global (or total) primary prevention already could be made on the basis of a balanced evaluation of the benefit/risk ratio. PMID:25873555

  1. Genetic basis of Cowden syndrome and its implications for clinical practice and risk management

    PubMed Central

    Gammon, Amanda; Jasperson, Kory; Champine, Marjan

    2016-01-01

    Cowden syndrome (CS) is an often difficult to recognize hereditary cancer predisposition syndrome caused by mutations in phosphatase and tensin homolog deleted on chromosome 10 (PTEN). In addition to conferring increased cancer risks, CS also predisposes individuals to developing hamartomatous growths in many areas of the body. Due to the rarity of CS, estimates vary on the penetrance of certain phenotypic features, such as macrocephaly and skin findings (trichilemmomas, mucocutaneous papules), as well as the conferred lifetime cancer risks. To address this variability, separate clinical diagnostic criteria and PTEN testing guidelines have been created to assist clinicians in the diagnosis of CS. As knowledge of CS increases, making larger studies of affected patients possible, these criteria continue to be refined. Similarly, the management guidelines for cancer screening and risk reduction in patients with CS continue to be updated. This review will summarize the current literature on CS to assist clinicians in staying abreast of recent advances in CS knowledge, diagnostic approaches, and management. PMID:27471403

  2. Clinical characteristics and risk factors for concurrent bacteremia in adults with dengue hemorrhagic fever.

    PubMed

    Lee, Ing-Kit; Liu, Jien-Wei; Yang, Kuender D

    2005-02-01

    To better understand the clinical characteristics of concurrent bacteremia (dual infection) in patients with dengue hemorrhagic fever/dengue shock syndrome (DHF/DSS) and identify predictive risk factors for dual infection, 100 patients with DHF/DSS (7 with a dual infection and 93 with DHF/DSS alone [controls]) were enrolled in this study. A patient with DHF/DSS who lacked three or more of the five most frequently observed manifestations other than fever in controls or showed disturbed consciousness was defined as one with unusual dengue manifestations. Patients with a dual infection were older, and tended to have prolonged fever, higher frequencies of acute renal failure, gastrointestinal bleeding, altered consciousness, unusual dengue manifestations, and DSS. Acute renal failure (odds ratio [OR] = 51.45, P = 0.002), and prolonged fever (> 5 days) (OR = 26.07, P = 0.017) were independent risk factors for dual infection. Clinicians should be alert to the potential for concurrent bacteremia when treating patients with DHF/DSS who are at risk for dual infection and manage them accordingly.

  3. Pilot Clinical Trial of Indocyanine Green Fluorescence-Augmented Colonoscopy in High Risk Patients.

    PubMed

    Sheth, Rahul A; Heidari, Pedram; Woods, Kevin; Chung, Daniel; Chan, Andrew T; Mahmood, Umar

    2016-01-01

    White light colonoscopy is the current gold standard for early detection and treatment of colorectal cancer, but emerging data suggest that this approach is inherently limited. Even the most experienced colonoscopists, under optimal conditions, miss at least 15-25% of adenomas. There is an unmet clinical need for an adjunctive modality to white light colonoscopy with improved lesion detection and characterization. Optical molecular imaging with exogenously administered organic fluorochromes is a burgeoning imaging modality poised to advance the capabilities of colonoscopy. In this proof-of-principle clinical trial, we investigated the ability of a custom-designed fluorescent colonoscope and indocyanine green, a clinically approved fluorescent blood pool imaging agent, to visualize polyps in high risk patients with polyposis syndromes or known distal colonic masses. We demonstrate (1) the successful performance of real-time, wide-field fluorescence endoscopy using off-the-shelf equipment, (2) the ability of this system to identify polyps as small as 1 mm, and (3) the potential for fluorescence imaging signal intensity to differentiate between neoplastic and benign polyps. PMID:26989406

  4. Low agreement for assessing the risk of postoperative deep venous thrombosis when deciding prophylaxis strategies: a study using clinical vignettes

    PubMed Central

    O'Flaherty, Martin; Lerum, Kaja; Martin, Paula; Grassi, Daniel

    2002-01-01

    Background Several clinical practice guidelines (CPG) on antithrombotic prophylaxis in surgical patients help to decide about the prophylaxis strategy based on the patient risk of deep venous thrombosis (DVT). However, the physician risk estimates of DVT could have little inter-observer reproducibility, which could lead to different individual prophylaxis practices. Methods Physicians were asked to evaluate DVT risk in eight clinical vignettes, describing actual patients cared for in our hospital. The vignettes included all possible levels of DVT risk. Results The degree of prophylaxis strategies accuracy was 63% (95% CI 523–75%). Overall agreement was 0.32 (z = 7.61, p < 0.001) and for each level of risk kappa was 0.38 (z = 6.50, p < 0.001); 0.1 (z = 1.65, p < 0.049) and 0.5 (z = 8.45, p < 0.001) for small, moderate and high risk group respectively Conclusions Our results showed that there is poor agreement when physicians have to evaluate the risk for postoperative DVT, and in the cases of low and moderate risks of DVT there is the smallest agreement. In addition, the data also showed that the overall accuracy of DVT prophylaxis strategy was only moderate and the risk evaluation did not correlate to the selection of the strategy. The issue of inter-observers variability should be taken into account when CPG performance are analysed, especially when considering the risk-evaluation to choose the appropriate actions. PMID:12184817

  5. READMIT: a clinical risk index to predict 30-day readmission after discharge from acute psychiatric units.

    PubMed

    Vigod, Simone N; Kurdyak, Paul A; Seitz, Dallas; Herrmann, Nathan; Fung, Kinwah; Lin, Elizabeth; Perlman, Christopher; Taylor, Valerie H; Rochon, Paula A; Gruneir, Andrea

    2015-02-01

    Our aim was to create a clinically useful risk index, administered prior to discharge, for determining the probability of psychiatric readmission within 30 days of hospital discharge for general psychiatric inpatients. We used population-level sociodemographic and health administrative data to develop a predictive model for 30-day readmission among adults discharged from an acute psychiatric unit in Ontario, Canada (2008-2011), and converted the final model into a risk index system. We derived the predictive model in one-half of the sample (n = 32,749) and validated it in the other half of the sample (n = 32,750). Variables independently associated with 30-day readmission (forming the mnemonic READMIT) were: (R) Repeat admissions; (E) Emergent admissions (i.e. harm to self/others); (D) Diagnoses (psychosis, bipolar and/or personality disorder), and unplanned Discharge; (M) Medical comorbidity; (I) prior service use Intensity; and (T) Time in hospital. Each 1-point increase in READMIT score (range 0-41) increased the odds of 30-day readmission by 11% (odds ratio 1.11, 95% CI 1.10-1.12). The index had moderate discriminative capacity in both derivation (C-statistic = 0.631) and validation (C-statistic = 0.630) datasets. Determining risk of psychiatric readmission for individual patients is a critical step in efforts to address the potentially avoidable high rate of this negative outcome. The READMIT index provides a framework for identifying patients at high risk of 30-day readmission prior to discharge, and for the development, evaluation and delivery of interventions that can assist with optimizing the transition to community care for patients following psychiatric discharge.

  6. Sacral Insufficiency Fractures After Preoperative Chemoradiation for Rectal Cancer: Incidence, Risk Factors, and Clinical Course

    SciTech Connect

    Herman, Michael P.; Kopetz, Scott; Bhosale, Priya R.; Eng, Cathy; Skibber, John M.; Rodriguez-Bigas, Miguel A.; Feig, Barry W.; Chang, George J.; Delclos, Marc E.; Krishnan, Sunil; Crane, Christopher H.; Das, Prajnan

    2009-07-01

    Purpose: Sacral insufficiency (SI) fractures can occur as a late side effect of pelvic radiation therapy. Our goal was to determine the incidence, risk factors, and clinical course of SI fractures in patients treated with preoperative chemoradiation for rectal cancer. Materials and Methods: Between 1989 and 2004, 562 patients with non-metastatic rectal adenocarcinoma were treated with preoperative chemoradiation followed by mesorectal excision. The median radiotherapy dose was 45 Gy. The hospital records and radiology reports of these patients were reviewed to identify those with pelvic fractures. Radiology images of patients with pelvic fractures were then reviewed to identify those with SI fractures. Results: Among the 562 patients, 15 had SI fractures. The 3-year actuarial rate of SI fractures was 3.1%. The median time to SI fractures was 17 months (range, 2-34 months). The risk of SI fractures was significantly higher in women compared to men (5.8% vs. 1.6%, p = 0.014), and in whites compared with non-whites (4% vs. 0%, p = 0.037). On multivariate analysis, gender independently predicted for the risk of SI fractures (hazard ratio, 3.25; p = 0.031). Documentation about the presence or absence of pain was available for 13 patients; of these 7 (54%) had symptoms requiring pain medications. The median duration of pain was 22 months. No patient required hospitalization or invasive intervention for pain control. Conclusions: SI fractures were uncommon in patients treated with preoperative chemoradiation for rectal cancer. The risk of SI fractures was significantly higher in women. Most cases of SI fractures can be managed conservatively with pain medications.

  7. Long-Term Adoption of Caries Management by Risk Assessment Among Dental Students in a University Clinic

    PubMed Central

    Chaffee, Benjamin W.; Featherstone, John D. B.

    2015-01-01

    Objective Evaluate the long-term adoption of a risk-based caries management program at a university dental clinic. Methods We extracted data from electronic records of adult non-edentulous patients who underwent a comprehensive oral evaluation in the university predoctoral clinic, from July 2007 through June 2014 (N=21,984). Consistency with caries management guidelines was measured as the percentage of patients with caries risk designation (low, moderate, high, or extreme) and by the percentage of patients provided non-operative anti-caries agents within each designated caries-risk category. Additionally, we identified patient and provider characteristics associated with risk assessment completion and with provision of anti-caries therapy. Results The percentage of patients with documented caries risk grew steadily from 62.3% in 2007-2008 to 92.8% in 2013-2014. Overall, receipt of non-operative anti-caries agents increased with rising caries risk, from low (6.9%), moderate (14.1%), high (36.4%), to extreme (51.4%), but percentages were stable over the study period. Younger patients were more likely to have a completed risk assessment, and among high- and extreme-risk patients, delivery of anti-caries therapy was more common among patients who were younger, identified as Asian or Caucasian, received public dental benefits, or were seen by a student in the four-year doctoral program or in the final year of training. Conclusions Extensive compliance in documenting caries risk was achieved within a decade of implementing risk-based clinical guidelines. Caries risk was the most strongly associated of several factors related to delivery of non-operative therapy. In dental education, transition to a risk-based, prevention-focused curriculum may require a long-term commitment. PMID:25941147

  8. Prediction of Functional Outcome in Individuals at Clinical High Risk for Psychosis

    PubMed Central

    Carrión, Ricardo E.; McLaughlin, Danielle; Goldberg, Terry E.; Auther, Andrea M.; Olsen, Ruth H.; Olvet, Doreen M.; Correll, Christoph U.; Cornblatt, Barbara A.

    2014-01-01

    Importance A major public health concern associated with schizophrenia and psychotic disorders is the long-term disability that involves impaired cognition, lack of social support, and an inability to function independently in the community. A critical goal of early detection and intervention studies in psychosis is therefore to understand the factors leading to this often profound impairment. Objective To develop a predictive model of functional (social and role) outcome in a clinical high-risk sample for psychosis. Design Prospective, naturalistic, longitudinal 3- to 5-year follow-up study. Setting The Recognition and Prevention Program in New York, a research clinic located in the Zucker Hillside Hospital in New York. Participants One hundred one treatment-seeking patients at clinical high risk for psychosis. Ninety-two (91%) were followed up prospectively for a mean (SD) of 3 (1.6) years. Intervention Neurocognitive and clinical assessment. Main Outcomes and Measures The primary outcome variables were social and role functioning at the last follow-up visit. Results Poor social outcome was predicted by reduced processing speed (odds ratio [OR], 1.38; 95% CI, 1.050-1.823; P = .02), impaired social functioning at baseline (OR, 1.85; 95% CI, 1.258-2.732; P = .002), and total disorganized symptoms (OR, 5.06; 95% CI, 1.548-16.527; P = .007). Reduced performance on tests for verbal memory (OR, 1.74; 95% CI, 1.169-2.594; P = .006), role functioning at baseline (OR, 1.34; 95% CI, 1.053-1.711; P = .02), and motor disturbances (OR, 1.77; 95% CI, 1.060-2.969; P = .03) predicted role outcome. The areas under the curve for the social and role prediction models were 0.824 (95% CI, 0.736-0.913; P < .001) and 0.77 (95% CI, 0.68-0.87; P < .001), respectively, demonstrating a high discriminative ability. In addition, poor functional outcomes were not entirely dependent on the development of psychosis, because 40.3% and 45.5% of nonconverters at clinical high risk had poor social

  9. Statin Use and Risk of Primary Liver Cancer in the Clinical Practice Research Datalink

    PubMed Central

    Hagberg, Katrina; Chen, Jie; Graubard, Barry I.; London, W. Thomas; Jick, Susan; Sahasrabuddhe, Vikrant V.

    2015-01-01

    Background: Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are widely prescribed to reduce cholesterol levels. Studies have suggested that statins are associated with reduced risk of liver cancer, but much of the evidence is from regions of the world with high liver cancer incidence rates. The current study examined the statins–liver cancer relationship in a low-rate region and examined the effects of preexisting liver disease and diabetes on that association. Methods: A nested case-control study was conducted within the United Kingdom’s Clinical Practice Research Datalink (CPRD). Persons diagnosed with primary liver cancer between 1988 and 2011 were matched to controls at a four-to-one ratio. Matches stratified on liver disease and on diabetes were also completed. Odds ratios (ORs) and 95% confidence intervals (CIs) for associations of statins with liver cancer were estimated using conditional logistic regression. Results: In total, 1195 persons with primary liver cancer were matched to 4640 control patients. Statin use was associated with a statistically significantly reduced risk of liver cancer (ORadj = 0.55, 95% CI = 0.45 to 0.69), especially among current users (ORadj = 0.53, 95% CI = 0.42 to 0.66). The reduced risk was statistically significant in the presence (ORadj = 0.32, 95% CI = 0.17 to 0.57) and absence of liver disease (ORadj = 0.65, 95% CI = 0.52 to 0.81) and in the presence (ORadj = 0.30, 95% CI = 0.21 to 0.42) and absence of diabetes (ORadj = 0.66, 95% CI = 0.51 to 0.85). Conclusions: In the current study in a low-rate area, statin use was associated with a statistically significantly reduced risk of liver cancer overall. Risk was particularly reduced among persons with liver disease and persons with diabetes, suggesting that statin use may be especially beneficial in persons at elevated risk of liver cancer. PMID:25722350

  10. Clinical practice in febrile neutropenia risk assessment and granulocyte colony-stimulating factor primary prophylaxis of febrile neutropenia in Poland

    PubMed Central

    Chmielowska, Ewa; Filipczyk-Cisarż, Emilia; Krzemieniecki, Krzysztof; Leśniewski-Kmak, Krzysztof; Litwiniuk, Maria M.; Wieruszewska-Kowalczyk, Karolina; Kosno-Kruszewska, Elżbieta

    2014-01-01

    Aim of the study The first aim was to investigate the knowledge and awareness of oncologists concerning febrile neutropenia (FN) risk assessment and indications for granulocyte colony-stimulating factor (G-CSF) primary prophylaxis (PP), based on current therapeutic guidelines (PTOK and EORTC). The second aim was to educate the oncologists on best practices for risk assessment and neutropenia management. Material and methods The project participants included 169 oncologists from 7 regions working in large specialist oncological centres, university hospitals, regional and city hospitals, specialist outpatient clinics, and oncological wards in small local hospitals. The participants completed a questionnaire based on seven prepared clinical cases of patients with different tumour types and patient characteristics, receiving chemotherapy (CT), and with different levels of FN risk. Participants answered questions related to FN risk assessment and G-CSF use. After completing the questionnaire, the participants proceeded to an educational module in which they were provided with an analysis of correct diagnostic and therapeutic procedures according to the PTOK and EORTC guidelines. Results and Conclusions Febrile neutropenia risk assessment was found to be a routine procedure performed for over 90% of the clinical cases by the participant oncologists. However, the FN risk assessment of clinical cases was correct and consistent with therapeutic guidelines in only 65% of responses. Indications for G-CSF PP were properly identified in 76% of responses and it appeared that indications for G-CSF PP were more likely to be correctly identified in patients receiving high-risk or low-risk regimens than in those receiving intermediate-risk regimens, where the decision to give G-CSF PP is based on additional assessment of patient risk factors. The vast majority of participants who correctly identified the need for PP administered G-CSF in accordance with the dose and schedule

  11. Version 3 of the historical-clinical-risk management-20 (HCR-20V3): relevance to violence risk assessment and management in forensic conditional release contexts.

    PubMed

    Douglas, Kevin S

    2014-09-01

    The conditional release of insanity acquittees requires decisions both about community risk level and the contextual factors that may mitigate or aggravate risk. This article discusses the potential role of the newly revised Historical-Clinical-Risk Management-20 (HCR-20, Version 3) within the conditional release context. A brief review of the structured professional judgment (SPJ) approach to violence risk assessment and management is provided. Version 2 of the HCR-20, which has been broadly adopted and evaluated, is briefly described. New features of Version 3 of the HCR-20 with particular relevance to conditional release decision-making are reviewed, including: item indicators; ratings of the relevance of risk factors to an individual's violence; risk formulation; scenario planning; and risk management planning. Version 3 of the HCR-20 includes a number of features that should assist evaluators and decision-makers to determine risk level, as well as to anticipate and specify community conditions and contexts that may mitigate or aggravate risk. Research on the HCR-20 Version 3 using approximately 800 participants across three settings (forensic psychiatric, civil psychiatric, correctional) and eight countries is reviewed.

  12. Version 3 of the historical-clinical-risk management-20 (HCR-20V3): relevance to violence risk assessment and management in forensic conditional release contexts.

    PubMed

    Douglas, Kevin S

    2014-09-01

    The conditional release of insanity acquittees requires decisions both about community risk level and the contextual factors that may mitigate or aggravate risk. This article discusses the potential role of the newly revised Historical-Clinical-Risk Management-20 (HCR-20, Version 3) within the conditional release context. A brief review of the structured professional judgment (SPJ) approach to violence risk assessment and management is provided. Version 2 of the HCR-20, which has been broadly adopted and evaluated, is briefly described. New features of Version 3 of the HCR-20 with particular relevance to conditional release decision-making are reviewed, including: item indicators; ratings of the relevance of risk factors to an individual's violence; risk formulation; scenario planning; and risk management planning. Version 3 of the HCR-20 includes a number of features that should assist evaluators and decision-makers to determine risk level, as well as to anticipate and specify community conditions and contexts that may mitigate or aggravate risk. Research on the HCR-20 Version 3 using approximately 800 participants across three settings (forensic psychiatric, civil psychiatric, correctional) and eight countries is reviewed. PMID:25278316

  13. Altered relationships between age and functional brain activation in adolescents at clinical high risk for psychosis

    PubMed Central

    Karlsgodt, Katherine H.; van Erp, Theo G.M.; Bearden, Carrie E.; Cannon, Tyrone D.

    2014-01-01

    Schizophrenia is considered a neurodevelopmental disorder, but whether the adolescent period, proximal to onset, is associated with aberrant development in individuals at clinical high risk (CHR) for psychosis is incompletely understood. While abnormal gray and white matter development has been observed, alterations in functional neuroimaging (fMRI) parameters during adolescence as related to conversion to psychosis have not yet been investigated. Twenty CHR individuals and 19 typically developing controls (TDC), (ages 14-21), were recruited from the Center for Assessment and Prevention of Prodromal States (CAPPS) at UCLA. Participants performed a Sternberg-style verbal working memory (WMem) task during fMRI and data were analyzed using a cross-sectional design to test the hypothesis that there is a deviant developmental trajectory in WMem associated neural circuitry in those at risk for psychosis. Eight of the CHR adolescents converted to psychosis within 2 years of initial assessment. A voxel-wise regression examining the relationship between age and activation revealed a significant group-by-age interaction. TDC showed a negative association between age and functional activation in the WMem circuitry while CHR adolescents showed a positive association. Moreover, CHR patients who later converted to overt psychosis showed a distinct pattern of abnormal age-associated activation in the frontal cortex relative to controls, while non-converters showed a more diffuse posterior pattern. Finding that age related variation in baseline patterns of neural activity differentiate individuals who subsequently convert to psychosis from healthy subjects suggests that these differences are likely to be clinically relevant. PMID:24144510

  14. Altered relationships between age and functional brain activation in adolescents at clinical high risk for psychosis.

    PubMed

    Karlsgodt, Katherine H; van Erp, Theo G M; Bearden, Carrie E; Cannon, Tyrone D

    2014-01-30

    Schizophrenia is considered a neurodevelopmental disorder, but whether the adolescent period, proximal to onset, is associated with aberrant development in individuals at clinical high risk (CHR) for psychosis is incompletely understood. While abnormal gray and white matter development has been observed, alterations in functional neuroimaging (fMRI) parameters during adolescence as related to conversion to psychosis have not yet been investigated. Twenty CHR individuals and 19 typically developing controls (TDC), (ages 14-21), were recruited from the Center for Assessment and Prevention of Prodromal States (CAPPS) at UCLA. Participants performed a Sternberg-style verbal working memory (WMem) task during fMRI and data were analyzed using a cross-sectional design to test the hypothesis that there is a deviant developmental trajectory in WMem associated neural circuitry in those at risk for psychosis. Eight of the CHR adolescents converted to psychosis within 2 years of initial assessment. A voxel-wise regression examining the relationship between age and activation revealed a significant group-by-age interaction. TDC showed a negative association between age and functional activation in the WMem circuitry while CHR adolescents showed a positive association. Moreover, CHR patients who later converted to overt psychosis showed a distinct pattern of abnormal age-associated activation in the frontal cortex relative to controls, while non-converters showed a more diffuse posterior pattern. Finding that age related variation in baseline patterns of neural activity differentiate individuals who subsequently convert to psychosis from healthy subjects suggests that these differences are likely to be clinically relevant. PMID:24144510

  15. Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson's disease.

    PubMed

    Master, Zubin; McLeod, Marcus; Mendez, Ivar

    2007-03-01

    Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson's disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical studies transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson's disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinical research of Parkinson's disease are derived. The potential benefits to research participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson's disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potential risk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit to risk calculus and to provide participants with a reasonable choice before they enroll in clinical studies.

  16. Cardiovascular Risk and Level of Statin Use Among Women With Breast Cancer in a Cardio-Oncology Clinic

    PubMed Central

    Shum, Kelly; Solivan, Amber; Parto, Parham; Polin, Nichole; Jahangir, Eiman

    2016-01-01

    Background: Because of the improvements in survival rates, patients with breast cancer are now more likely to die from cardiovascular disease than from cancer. Thus, providing appropriate preventive cardiovascular care to patients with cancer is of the utmost importance. Methods: We retrospectively compared the cardiovascular risk and management of 146 women treated at the Cardio-Oncology (Cardio-Onc) and the Obstetrics and Gynecology (Ob-Gyn) clinics. We calculated cardiovascular risk using the American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk calculator and the Framingham Risk Score Calculator. We also determined the prevalence of appropriate statin use according to both the 2013 ACC/AHA and the 2002 Adult Treatment Panel (ATP) III lipid guidelines. Results: The 10-year ASCVD risk score was not significantly different between the 2 cohorts. More patients in the Ob-Gyn cohort with an ASCVD risk score >7.5% were already appropriately on statins compared to patients in the Cardio-Onc cohort (60.9% vs 31.0%, respectively, P=0.003), but after the first Cardio-Onc visit, 4 additional patients with breast cancer were prescribed statins (44.8% total). Fourteen (19.2%) Cardio-Onc patients had a high Framingham Risk Score compared to 6 (8.2%) Ob-Gyn patients. Conclusion: We demonstrated that the ASCVD risk is similar between women with breast cancer attending the Cardio-Onc clinic and the women without breast cancer attending the Ob-Gyn clinic, but the Cardio-Onc cohort had significantly more patients with a high Framingham Risk Score. Both clinics had similarly poor rates of appropriate statin prescribing rates according to the ATP III guidelines.

  17. Cardiovascular Risk and Level of Statin Use Among Women With Breast Cancer in a Cardio-Oncology Clinic

    PubMed Central

    Shum, Kelly; Solivan, Amber; Parto, Parham; Polin, Nichole; Jahangir, Eiman

    2016-01-01

    Background: Because of the improvements in survival rates, patients with breast cancer are now more likely to die from cardiovascular disease than from cancer. Thus, providing appropriate preventive cardiovascular care to patients with cancer is of the utmost importance. Methods: We retrospectively compared the cardiovascular risk and management of 146 women treated at the Cardio-Oncology (Cardio-Onc) and the Obstetrics and Gynecology (Ob-Gyn) clinics. We calculated cardiovascular risk using the American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk calculator and the Framingham Risk Score Calculator. We also determined the prevalence of appropriate statin use according to both the 2013 ACC/AHA and the 2002 Adult Treatment Panel (ATP) III lipid guidelines. Results: The 10-year ASCVD risk score was not significantly different between the 2 cohorts. More patients in the Ob-Gyn cohort with an ASCVD risk score >7.5% were already appropriately on statins compared to patients in the Cardio-Onc cohort (60.9% vs 31.0%, respectively, P=0.003), but after the first Cardio-Onc visit, 4 additional patients with breast cancer were prescribed statins (44.8% total). Fourteen (19.2%) Cardio-Onc patients had a high Framingham Risk Score compared to 6 (8.2%) Ob-Gyn patients. Conclusion: We demonstrated that the ASCVD risk is similar between women with breast cancer attending the Cardio-Onc clinic and the women without breast cancer attending the Ob-Gyn clinic, but the Cardio-Onc cohort had significantly more patients with a high Framingham Risk Score. Both clinics had similarly poor rates of appropriate statin prescribing rates according to the ATP III guidelines. PMID:27660568

  18. Sharp mandibular bone irregularities after lower third molar extraction: Incidence, clinical features and risk factors

    PubMed Central

    Alves-Pereira, Daniela; Valmaseda-Castellón, Eduard; Laskin, Daniel M.; Berini-Aytés, Leonardo; Gay-Escoda, Cosme

    2013-01-01

    Objectives: The purpose of this study was to determine the incidence and clinical symptoms associated with sharp mandibular bone irregularities (SMBI) after lower third molar extraction and to identify possible risk factors for this complication. Study Design: A mixed study design was used. A retrospective cohort study of 1432 lower third molar extractions was done to determine the incidence of SMBI and a retrospective case-control study was done to determine potential demographic and etiologic factors by comparing those patients with postoperative SMBI with controls. Results: Twelve SMBI were found (0.84%). Age was the most important risk factor for this complication. The operated side and the presence of an associated radiolucent image were also significantly related to the development of mandibular bone irregularities. The depth of impaction of the tooth might also be an important factor since erupted or nearly erupted third molars were more frequent in the SMBI group. Conclusions: SMBI are a rare postoperative complication after lower third molar removal. Older patients having left side lower third molars removed are more likely to develop this problem. The treatment should be the removal of the irregularity when the patient is symptomatic. Key words:Third molar, postoperative complication, bone irregularities, age. PMID:23524429

  19. Clinical Dementia Rating Scale Detects White Matter Changes in Older Adults at Risk for Alzheimer's Disease.

    PubMed

    Chang, Yu-Ling; Yen, Yu-Shiuan; Chen, Ta-Fu; Yan, Sui-Hing; Tseng, Wen-Yih Isaac

    2015-01-01

    This study investigated the putative changes in regional gray matter and cingulum bundle segments in mild cognitive impairment (MCI) by using two diagnostic criteria. Participants comprised 50 older adults with MCI and 22 healthy older controls (HC). The older adults with MCI were further divided into two groups defined by a global Clinical Dementia Rating (CDR) score of 0.5 and with (the CDR/NPT MCI group) or without (the CDR MCI group) objective cognitive impairments determined using neuropsychological tests (NPTs). Comparable regional gray matter integrity was observed among the three groups. However, the integrity of the right inferior segment of the cingulum bundle in the two MCI groups was more reduced than that in the HC group, and the CDR/NPT MCI group exhibited additional disruption in the left inferior cingulum bundle. The results also demonstrated that neuropsychological measures have greater predictive value for changes in white matter beyond the contribution of an informant-based instrument alone. Overall, the findings confirm the utility of informant-based assessment in detecting microstructural brain changes in high-risk older adults, even before objective cognitive impairment is evident. The findings also suggest that combining the neuropsychological measures with the informant-based assessment provided the greatest predictive value in assessing white matter disruption. The essential role of the white matter measurement as a biomarker for detecting individuals at a high risk of developing dementia was highlighted.

  20. Clinical relevancy and risks of potential drug–drug interactions in intensive therapy

    PubMed Central

    Rodrigues, Aline Teotonio; Stahlschmidt, Rebeca; Granja, Silvia; Falcão, Antonio Luis Eiras; Moriel, Patricia; Mazzola, Priscila Gava

    2014-01-01

    Purpose Evaluate the potential Drug–Drug Interactions (pDDI) found in prescription orders of adult Intensive Care Unit (ICU) of a Brazilian public health system hospital; quantify and qualify the pDDI regarding their severity and risks to the critical patient, using the database from Micromedex®. Methods Prospective study (January–December of 2011) collecting and evaluating 369 prescription orders (convenient sampling), one per patient. Results During the study 1844 pDDIs were identified and distributed in 405 pairs (medication A × medication B combination). There was an average of 5.00 ± 5.06 pDDIs per prescription order, the most prevalent being moderate and important interactions, present in 74% and 67% of prescription orders, respectively. In total, there were 9 contraindicated, 129 important and 204 moderate pDDIs. Among them 52 had as management recommendation to “avoid concomitant use” or “suspension of medication”, while 306 had as recommendation “continuous and adequate monitoring”. Conclusion The high number of pDDIs found in the study combined with the evaluation of the clinical relevancy of the most frequent pDDIs in the ICU shows that moderate and important interactions are highly incident. As the majority of them demand monitoring and adequate management, being aware of these interactions is major information for the safe and individualized risk management. PMID:27134536

  1. Fatherhood and depression: a review of risks, effects, and clinical application.

    PubMed

    Spector, Aaron Z

    2006-10-01

    This literature review attempted to compile a complete evaluation of the presentation, risks, and subsequent effects upon a family in relation to paternal depression. Clinical applications are reviewed as well. As with women, fathers will present with a dysphoric mood, but unlike their female counterparts, depressed men often experience a change in social behavior. Withdrawal from social situations, indecisiveness, cynicism, and an irritable mood are often found as hallmark signs of depression in the adult male. Life stress, or family stress and low social support, are risk factors associated with depression among fathers. Marital difficulties may be the most common trigger for first-time depression in husbands just as divorce amplifies depressive episodes, especially when children are involved. A variety of treatments have proven effective for depressed fathers including traditional psycho-dynamic, CBT, and group therapy. Therapy is effective when it can be initiated and continued but research repeatedly showed that men seek it out far less than women. Effective outreach programs to encourage treatment among depressed fathers are recommended.

  2. Complacent and conflicting scientific expertise in British and American drug regulation: clinical risk assessment of triazolam.

    PubMed

    Abraham, J; Sheppard, J

    1999-12-01

    This paper presents a case study in the production and interpretation of regulatory science, focusing on the conflicting British and American clinical risk assessments of triazolam (Halcion) - the most controversial sleeping pill in the world. The regulation of triazolam is shown to be more permissive in the USA than in the UK. Six principal socio-political factors are put forward to explain this; differential regulatory trust; regulators' socio-technical data selections; medico-scientific disciplinary influences; organizational and professional interests; conflicts of interest of expert advisers; and the growth of the neo-liberal regulatory state. The risk assessments of both the British and American regulatory agencies are shown to be complacent relative to technical standards which the agencies themselves later accepted. It is suggested that, when the interests of pharmaceutical manufacturers and patients diverge, regulatory assessments are crucially affected by whether regulators are predisposed to award the benefit of the scientific doubts to the manufacturers or patients, and by the balance of such predispositions both within and between regulatory institutions of scientific expertise. The triazolam case indicates that the amount of trust placed in the pharmaceutical industry by the British American regulatory systems may hamper detection of flaws in manufacturers' medical data in a timely manner and, as a consequence, compromise patients' interests. Some policy implications for drug regulation are sketched. PMID:11624110

  3. Development and Validation of a Clinical Risk-Assessment Tool Predictive of All-Cause Mortality

    PubMed Central

    Bello, Ghalib A; Dumancas, Gerard G; Gennings, Chris

    2015-01-01

    In clinical settings, the diagnosis of medical conditions is often aided by measurement of various serum biomarkers through the use of laboratory tests. These biomarkers provide information about different aspects of a patient’s health and overall function of multiple organ systems. We have developed a statistical procedure that condenses the information from a variety of health biomarkers into a composite index, which could be used as a risk score for predicting all-cause mortality. It could also be viewed as a holistic measure of overall physiological health status. This health status metric is computed as a function of standardized values of each biomarker measurement, weighted according to their empirically determined relative strength of association with mortality. The underlying risk model was developed using the biomonitoring and mortality data of a large sample of US residents obtained from the National Health and Nutrition Examination Survey (NHANES) and the National Death Index (NDI). Biomarker concentration levels were standardized using spline-based Cox regression models, and optimization algorithms were used to estimate the weights. The predictive accuracy of the tool was optimized by bootstrap aggregation. We also demonstrate how stacked generalization, a machine learning technique, can be used for further enhancement of the prediction power. The index was shown to be highly predictive of all-cause mortality and long-term outcomes for specific health conditions. It also exhibited a robust association with concurrent chronic conditions, recent hospital utilization, and current health status as assessed by self-rated health. PMID:26380550

  4. Complacent and conflicting scientific expertise in British and American drug regulation: clinical risk assessment of triazolam.

    PubMed

    Abraham, J; Sheppard, J

    1999-12-01

    This paper presents a case study in the production and interpretation of regulatory science, focusing on the conflicting British and American clinical risk assessments of triazolam (Halcion) - the most controversial sleeping pill in the world. The regulation of triazolam is shown to be more permissive in the USA than in the UK. Six principal socio-political factors are put forward to explain this; differential regulatory trust; regulators' socio-technical data selections; medico-scientific disciplinary influences; organizational and professional interests; conflicts of interest of expert advisers; and the growth of the neo-liberal regulatory state. The risk assessments of both the British and American regulatory agencies are shown to be complacent relative to technical standards which the agencies themselves later accepted. It is suggested that, when the interests of pharmaceutical manufacturers and patients diverge, regulatory assessments are crucially affected by whether regulators are predisposed to award the benefit of the scientific doubts to the manufacturers or patients, and by the balance of such predispositions both within and between regulatory institutions of scientific expertise. The triazolam case indicates that the amount of trust placed in the pharmaceutical industry by the British American regulatory systems may hamper detection of flaws in manufacturers' medical data in a timely manner and, as a consequence, compromise patients' interests. Some policy implications for drug regulation are sketched.

  5. Approval of high-risk medical devices in the US: implications for clinical cardiology.

    PubMed

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    2014-01-01

    Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative. PMID:24760423

  6. Clinical use of anti-TNF therapy and increased risk of infections

    PubMed Central

    Ali, Tauseef; Kaitha, Sindhu; Mahmood, Sultan; Ftesi, Abdul; Stone, Jordan; Bronze, Michael S

    2013-01-01

    Biologics such as antitumor necrosis factor (anti-TNF) drugs have emerged as important agents in the treatment of many chronic inflammatory diseases, especially in cases refractory to conventional treatment modalities. However, opportunistic infections have become a major safety concern in patients on anti-TNF therapy, and physicians who utilize these agents must understand the increased risks of infection. A literature review of the published data on the risk of bacterial, viral, fungal, and parasitic infections associated with anti-TNF therapy was performed and the clinical presentation, diagnostic tests, management, and prevention of opportunistic infections in patients receiving anti-TNF therapy were reviewed. Awareness of the therapeutic potential and associated adverse events is necessary for maximizing therapeutic benefits while minimizing adverse effects from anti-TNF treatments. Patients should be adequately vaccinated when possible and closely monitored for early signs of infection. When serious infections occur, withdrawal of anti-TNF therapy may be necessary until the infection has been identified and properly treated. PMID:23569399

  7. Approval of high-risk medical devices in the US: implications for clinical cardiology.

    PubMed

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    2014-01-01

    Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.

  8. Relation between cannabis use and subcortical volumes in people at clinical high risk of psychosis.

    PubMed

    Buchy, Lisa; Mathalon, Daniel H; Cannon, Tyrone D; Cadenhead, Kristin S; Cornblatt, Barbara A; McGlashan, Thomas H; Perkins, Diana O; Seidman, Larry J; Tsuang, Ming T; Walker, Elaine F; Woods, Scott W; Bearden, Carrie E; Addington, Jean

    2016-08-30

    Among people at genetic risk of schizophrenia, those who use cannabis show smaller thalamic and hippocampal volumes. We evaluated this relationship in people at clinical high risk (CHR) of psychosis. The Alcohol and Drug Use Scale was used to identify 132 CHR cannabis users, the majority of whom were non-dependent cannabis users, 387 CHR non-users, and 204 healthy control non-users, and all participants completed magnetic resonance imaging scans. Volumes of the thalamus, hippocampus and amygdala were extracted with FreeSurfer, and compared across groups. Comparing all CHR participants with healthy control participants revealed no significant differences in volumes of any ROI. However, when comparing CHR users to CHR non-users, a significant ROI×Cannabis group effect emerged: CHR users showed significantly smaller amygdala compared to CHR non-users. However, when limiting analysis to CHR subjects who reported using alcohol at a 'use without impairment' severity level, the amygdala effect was non-significant; rather, smaller hippocampal volumes were seen in CHR cannabis users compared to non-users. Controlling statistically for effects of alcohol and tobacco use rendered all results non-significant. These results highlight the importance of controlling for residual confounding effects of other substance use when examining the relationship between cannabis use and neural structure. PMID:27289213

  9. Neuropsychological Profiles in Individuals at Clinical High Risk for Psychosis: Relationship to Psychosis and Intelligence

    PubMed Central

    Woodberry, Kristen A.; Seidman, Larry J.; Giuliano, Anthony J.; Verdi, Mary B.; Cook, William L.; McFarlane, William R.

    2010-01-01

    Background Characterizing neuropsychological (NP) functioning of individuals at clinical high risk (CHR) for psychosis may be useful for prediction of psychosis and understanding functional outcome. The degree to which NP impairments are associated with general cognitive ability and/or later emergence of full psychosis in CHR samples requires study with well-matched controls. Methods We assessed NP functioning across eight cognitive domains in a sample of 73 CHR youth, 13 of whom developed psychotic-level symptoms after baseline assessment, and 34 healthy comparison (HC) subjects. Groups were matched on age, sex, ethnicity, handedness, subject and parent grade attainment, and median family income, and were comparable on WRAT-3 Reading, an estimate of premorbid IQ. Profile analysis was used to examine group differences and the role of IQ in profile shape. Results The CHR sample demonstrated a significant difference in overall magnitude of NP impairment but only a small and nearly significant difference in profile shape, primarily due to a large impairment in olfactory identification. Individuals who subsequently developed psychotic-level symptoms demonstrated large impairments in verbal IQ, verbal memory and olfactory identification comparable in magnitude to first episode samples. Conclusions CHR status may be associated with moderate generalized cognitive impairments marked by some degree of selective impairment in olfaction and verbal memory. Impairments were greatest in those who later developed psychotic symptoms. Future study of olfaction in CHR samples may enhance early detection and specification of neurodevelopmental mechanisms of risk. PMID:20692125

  10. Change in Neuropsychological Functioning over One Year in Youth at Clinical High Risk for Psychosis

    PubMed Central

    Woodberry, Kristen A.; McFarlane, William R.; Giuliano, Anthony J.; Verdi, Mary B.; Cook, William L.; Faraone, Stephen V.; Seidman, Larry J.

    2013-01-01

    Schizophrenia and related psychotic disorders are associated with significant neuropsychological (NP) impairments. Yet the onset and developmental evolution of these impairments remains incompletely characterized. This study examined NP functioning over one year in a sample of youth at clinical high risk (CHR) for psychosis participating in a treatment study. We assessed functioning across six cognitive domains at two time points in a sample of 53 CHR and 32 healthy comparison (HC) subjects. Linear regression of HC one-year scores was used to predict one-year performance for CHR from baseline scores and relevant demographic variables. We used raw scores and MANOVAs of the standardized residuals to test for progressive impairment over time. NP functioning of CHR at one year fell significantly below predicted levels. Effects were largest and most consistent for a failure of normative improvement on tests of executive function. CHR who reached the highest positive symptom rating (6, severe and psychotic) on the Structured Interview of Prodromal Syndromes after the baseline assessment (n = 10/53) demonstrated a particularly large (d= −1.89), although non-significant, discrepancy between observed and predicted one-year verbal memory test performance. Findings suggest that, although much of the cognitive impairment associated with psychosis is present prior to the full expression of the psychotic syndrome, some progressive NP impairments may accompany risk for psychosis and be greatest for those who develop psychotic level symptoms. PMID:23434505

  11. Clinical and laboratory characteristics and risk factors for fatality in elderly patients with dengue hemorrhagic fever.

    PubMed

    Lee, Ing-Kit; Liu, Jien-Wei; Yang, Kuender D

    2008-08-01

    To better understand the clinical and laboratory characteristics and to identify risk factor(s) for fatality in elderly patients with dengue hemorrhagic fever (DHF), 66 elderly (age > or = 65 years) and 241 non-elderly adults (age, 19-64 years) with DHF were retrospectively analyzed. Compared with non-elderly adults, elderly individuals had significantly lower incidences of fever (P = 0.002), abdominal pain (P = 0.003), bone pain (P < 0.001), and skin rashes (P = 0.002); higher frequencies of concurrent bacteremia (P = 0.049), gastrointestinal bleeding (P = 0.044), acute renal failure (P = 0.001), and pleural effusion (P < 0.010); higher incidence of prolonged prothrombin time (P = 0.025); lower mean hemoglobin level (P < 0.001); longer hospitalization (P = 0.049); and a higher fatality rate (P = 0.006). Five elderly patients with DHF died. When compared with non-fatal elderly patients with DHF, a significant higher frequency in men (P = 0.019), those with chronic obstructive pulmonary disease (P = 0.008), those with dengue shock syndrome (DSS; P < 0.001), and those with acute renal failure (P < 0.001) was found in the elderly counterparts that died. Multivariate analysis showed that only DSS (odd ratio = 77.33, P = 0.001) was an independent risk factor for fatality in elderly patients.

  12. Garlic powder intake and cardiovascular risk factors: a meta-analysis of randomized controlled clinical trials

    PubMed Central

    Kwak, Jin Sook; Kim, Ji Yeon; Paek, Ju Eun; Lee, You Jin; Kim, Haeng-Ran; Park, Dong-Sik

    2014-01-01

    BACKGROUND/OBJECTIVES Although preclinical studies suggest that garlic has potential preventive effects on cardiovascular disease (CVD) risk factors, clinical trials and reports from systematic reviews or meta-analyses present inconsistent results. The contradiction might be attributed to variations in the manufacturing process that can markedly influence the composition of garlic products. To investigate this issue further, we performed a meta-analysis of the effects of garlic powder on CVD risk factors. MATERIALS/METHODS We searched PubMed, Cochrane, Science Direct and EMBASE through May 2014. A random-effects meta-analysis was performed on 22 trials reporting total cholesterol (TC), 17 trials reporting LDL cholesterol (LDL-C), 18 trials reporting HDL cholesterol (HDL-C), 4 trials reporting fasting blood glucose (FBG), 9 trials reporting systolic blood pressure (SBP) and 10 trials reporting diastolic blood pressure (DBP). RESULTS The overall garlic powder intake significantly reduced blood TC and LDL-C by -0.41 mmol/L (95% confidence interval [CI], -0.69, -0.12) (-15.83 mg/dL [95% CI, -26.64, -4.63]) and -0.21 mmol/L (95% CI, -0.40, -0.03) (-8.11 mg/dL [95% CI, -15.44, -1.16]), respectively. The mean difference in the reduction of FBG levels was -0.96 mmol/L (95% CI, -1.91, -0.01) (-17.30 mg/dL [95% CI, -34.41, -0.18]). Evidence for SBP and DBP reduction in the garlic supplementation group was also demonstrated by decreases of -4.34 mmHg (95% CI, -8.38, -0.29) and -2.36 mmHg (95% CI, -4.56, -0.15), respectively. CONCLUSIONS This meta-analysis provides consistent evidence that garlic powder intake reduces the CVD risk factors of TC, LDL-C, FBG and BP. PMID:25489404

  13. Risk Factors and Clinical Outcomes of Bacterial and Fungal Scleritis at a Tertiary Eye Care Hospital

    PubMed Central

    Reddy, Jagadesh C.; Murthy, Somasheila I.; Reddy, Ashok K.; Garg, Prashant

    2015-01-01

    Purpose: The aim was to analyze demographics, risk factors, pathogenic organisms, and clinical outcome in cases with microbiologically proven bacterial or fungal scleritis. Materials and Methods: Retrospective review of all the medical records of patients with microbiologically proven infectious scleritis examined from March 2005 to December 2009 in the cornea services of L. V. Prasad Eye Institute, Hyderabad, India was done. Results: Forty-two eyes of 42 patients were included in this study. The mean age at presentation was 48.52 ± 14.10 years (range: 12-70). Surgery was the major risk factor seen in 24 eyes (58.5%). Scleral infection was noted after vitreoretinal surgery (with scleral buckle) in 15 eyes, cataract surgery in 3 eyes, pterygium surgery in 3 eyes, corneoscleral tear repair and scleral buckle surgery in 3 eyes. Sixteen eyes (39%) were on systemic or topical steroids at the time of presentation. History of injury was noted in 9 eyes (22%) and diabetes mellitus in 7 patients (17%). Associated keratitis was noted in 9 eyes (21.4%). The scleral abscess was unifocal in 33 eyes (78.5%), multifocal in 6 eyes (14.2%) and diffuse in 3 eyes (7.14%). The final follow-up ranged from 24 days to 37 months. The final visual acuity was better in 18 eyes (42.8%), stable in 13 (30.9%), and deteriorated in 7 eyes (16.6%). Recurrence was seen in 4 eyes (9.5%). Conclusions: Surgery is a major risk factor for infectious scleritis in our series. Fungus was the most common organism isolated. Thorough debridement and intensive use of medications have improved the outcome. PMID:25949079

  14. Impact of educational strategies in low-risk prenatal care: systematic review of randomized clinical trials.

    PubMed

    Silva, Esther Pereira da; Lima, Roberto Teixeira de; Osório, Mônica Maria

    2016-09-01

    This study aimed to analyze the impact of educational strategies developed in low-risk prenatal care on obstetric outcomes from a systematic literature review. This review consulted databases PubMed, Medline, SciELO and Lilacs, analyzing randomized clinical trials with the following birth outcomes: birth weight, prematurity and breastfeeding, using the following combination of keywords: pre-natal, antenatal visits, education, health education, pregnancy outcomes, birth weight, prematurity, breastfeeding and randomized clinical trial. Nine studies were included following quality evaluation. Actions prove to be more effective when extended to the postpartum period. Most of them occurred during home visits and had a positive impact on breastfeeding and birth weight. The establishment of groups of pregnant women contributed to lower prevalence of prematurity. Breastfeeding was found to be the outcome most sensitive to educational strategies. Educational practices during the prenatal period contributed to favorable obstetric outcomes as they minimized pregnant women concerns and anxiety during the pregnancy process, preparing them for childbirth and postpartum, and should be incorporated into health services' work process. PMID:27653079

  15. Risk factors, clinical presentation and prognosis of mixed candidaemia: a population-based surveillance in Spain.

    PubMed

    Ramos, Antonio; Romero, Yolanda; Sánchez-Romero, Isabel; Fortún, Jesús; Paño, José Ramón; Pemán, Javier; Gurguí, Mercè; Rodríguez-Baño, Jesús; Padilla, Belén

    2016-10-01

    The low incidence of mixed candidaemia (MC) may have precluded a better knowledge of its clinical presentation. The aim of the study was to analyse the risk factors, clinical presentation and prognosis of MC episodes. A comparison between MC and monomicrobial candidaemia within a prospective programme on candidaemia was performed in 29 hospitals between April 2010 and May 2011. In fifteen episodes of candidaemia corresponding to 15 patients, out of 752, two species of Candida (1.9%) were isolated. MC was more frequent in patients with HIV infection (12%, P = 0.038) and those admitted due to extensive burns (23%, P = 0.012). The Candida species most frequently identified in MC were C. albicans 12 patients (40%), C. glabrata seven patients (23.3%) and C. parapsilosis six patients (20%). Early mortality was higher (nine patients, 60%) in patients with MC than in patients with MMC (223 patients, 30.3%, P = 0.046). In conclusion, MC was was independently associated with increased mortality even after considering other prognostic factors. MC is an infrequent event that is more common in HIV infection and in patients suffering from burns, and is associated with increased mortality.

  16. Lipid target achievement among patients with very high and high cardiovascular risk in a lipid clinic.

    PubMed

    Barkas, Fotios; Liberopoulos, Evangelos N; Kostapanos, Michael S; Liamis, George; Tziallas, Dimitrios; Elisaf, Moses

    2015-04-01

    This was a retrospective study that assessed achievement of lipid-lowering treatment targets in the setting of a University Hospital Lipid Clinic. Low-density lipoprotein cholesterol (LDL-C) goal attainment according to National Cholesterol Education Program-Adult Treatment Panel III (NCEP ATP III) and European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines was recorded in 1000 consecutive adult patients followed for ≥3 years (mean 8 years). The LDL-C targets according to the NCEP ATP III were attained by 66% and 86% of patients with "very high" (n = 477) and "high" (n = 408) cardiovascular risk, respectively. Fewer patients were within LDL-C goals according to the ESC/EAS guidelines: 25% and 42%. Overall, 92% of the patients were on statins: 67% were on statin monotherapy, while 33% were on combinations with ezetimibe (25%), ω-3 fatty acids (5%), fibrates (4%), or colesevelam (2%). Even in a specialist lipid clinic, a large proportion of patients are not at goal according to the recent ESC/EAS guidelines. PMID:24830420

  17. The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance.

    PubMed

    Selen, Arzu; Dickinson, Paul A; Müllertz, Anette; Crison, John R; Mistry, Hitesh B; Cruañes, Maria T; Martinez, Marilyn N; Lennernäs, Hans; Wigal, Tim L; Swinney, David C; Polli, James E; Serajuddin, Abu T M; Cook, Jack A; Dressman, Jennifer B

    2014-11-01

    The biopharmaceutics risk assessment roadmap (BioRAM) optimizes drug product development and performance by using therapy-driven target drug delivery profiles as a framework to achieve the desired therapeutic outcome. Hence, clinical relevance is directly built into early formulation development. Biopharmaceutics tools are used to identify and address potential challenges to optimize the drug product for patient benefit. For illustration, BioRAM is applied to four relatively common therapy-driven drug delivery scenarios: rapid therapeutic onset, multiphasic delivery, delayed therapeutic onset, and maintenance of target exposure. BioRAM considers the therapeutic target with the drug substance characteristics and enables collection of critical knowledge for development of a dosage form that can perform consistently for meeting the patient's needs. Accordingly, the key factors are identified and in vitro, in vivo, and in silico modeling and simulation techniques are used to elucidate the optimal drug delivery rate and pattern. BioRAM enables (1) feasibility assessment for the dosage form, (2) development and conduct of appropriate "learning and confirming" studies, (3) transparency in decision-making, (4) assurance of drug product quality during lifecycle management, and (5) development of robust linkages between the desired clinical outcome and the necessary product quality attributes for inclusion in the quality target product profile.

  18. Impact of educational strategies in low-risk prenatal care: systematic review of randomized clinical trials.

    PubMed

    Silva, Esther Pereira da; Lima, Roberto Teixeira de; Osório, Mônica Maria

    2016-09-01

    This study aimed to analyze the impact of educational strategies developed in low-risk prenatal care on obstetric outcomes from a systematic literature review. This review consulted databases PubMed, Medline, SciELO and Lilacs, analyzing randomized clinical trials with the following birth outcomes: birth weight, prematurity and breastfeeding, using the following combination of keywords: pre-natal, antenatal visits, education, health education, pregnancy outcomes, birth weight, prematurity, breastfeeding and randomized clinical trial. Nine studies were included following quality evaluation. Actions prove to be more effective when extended to the postpartum period. Most of them occurred during home visits and had a positive impact on breastfeeding and birth weight. The establishment of groups of pregnant women contributed to lower prevalence of prematurity. Breastfeeding was found to be the outcome most sensitive to educational strategies. Educational practices during the prenatal period contributed to favorable obstetric outcomes as they minimized pregnant women concerns and anxiety during the pregnancy process, preparing them for childbirth and postpartum, and should be incorporated into health services' work process.

  19. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance.

    PubMed

    Huh, Warner K; Ault, Kevin A; Chelmow, David; Davey, Diane D; Goulart, Robert A; Garcia, Francisco A; Kinney, Walter K; Massad, L Stewart; Mayeaux, Edward J; Saslow, Debbie; Schiffman, Mark; Wentzensen, Nicolas; Lawson, Herschel W; Einstein, Mark H

    2015-04-01

    In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology or cotesting (cytology in combination with high-risk HPV (hrHPV) testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective US-based registration study. Thirteen experts including representatives from the Society of Gynecologic Oncology, American Society for Colposcopy and Cervical Pathology, American College of Obstetricians and Gynecologists, American Cancer Society, American Society of Cytopathology, College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the FDA for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for health care providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.

  20. Epidemiology, contributors to, and clinical trials of mortality risk in chronic kidney failure.

    PubMed

    Ortiz, Alberto; Covic, Adrian; Fliser, Danilo; Fouque, Denis; Goldsmith, David; Kanbay, Mehmet; Mallamaci, Francesca; Massy, Ziad A; Rossignol, Patrick; Vanholder, Raymond; Wiecek, Andrzej; Zoccali, Carmine; London, Gérard M

    2014-05-24

    Patients with chronic kidney failure--defined as a glomerular filtration rate persistently below 15 mL/min per 1·73 m(2)--have an unacceptably high mortality rate. In developing countries, mortality results primarily from an absence of access to renal replacement therapy. Additionally, cardiovascular and non-cardiovascular mortality are several times higher in patients on dialysis or post-renal transplantation than in the general population. Mortality of patients on renal replacement therapy is affected by a combination of socioeconomic factors, pre-existing medical disorders, renal replacement treatment modalities, and kidney failure itself. Characterisation of the key pathophysiological contributors to increased mortality and cardiorenal risk staging systems are needed for the rational design of clinical trials aimed at decreasing mortality. Policy changes to improve access to renal replacement therapy should be combined with research into low-cost renal replacement therapy and optimum clinical care, which should include multifaceted approaches simultaneously targeting several of the putative contributors to increased mortality.

  1. Do Clinical Standards for Diabetes Care Address Excess Risk for Hypoglycemia in Vulnerable Patients? A Systematic Review

    PubMed Central

    Berkowitz, Seth A; Aragon, Katherine; Hines, Jonas; Seligman, Hilary; Lee, Sei; Sarkar, Urmimala

    2013-01-01

    Objective To determine whether diabetes clinical standards consider increased hypoglycemia risk in vulnerable patients. Data Sources MEDLINE, the National Guidelines Clearinghouse, the National Quality Measures Clearinghouse, and supplemental sources. Study Design Systematic review of clinical standards (guidelines, quality metrics, or pay-for-performance programs) for glycemic control in adult diabetes patients. The primary outcome was discussion of increased risk for hypoglycemia in vulnerable populations. Data Collection/Extraction Methods Manuscripts identified were abstracted by two independent reviewers using prespecified inclusion/exclusion criteria and a standardized abstraction form. Principal Findings We screened 1,166 titles, and reviewed 220 manuscripts in full text. Forty-four guidelines, 17 quality metrics, and 8 pay-for-performance programs were included. Five (11 percent) guidelines and no quality metrics or pay-for-performance programs met the primary outcome. Conclusions Clinical standards do not substantively incorporate evidence about increased risk for hypoglycemia in vulnerable populations. PMID:23445498

  2. Susceptibility of high-risk human papillomavirus type 16 to clinical disinfectants

    PubMed Central

    Meyers, Jordan; Ryndock, Eric; Conway, Michael J.; Meyers, Craig; Robison, Richard

    2014-01-01

    Objectives Little to nothing is known about human papillomavirus (HPV) susceptibility to disinfection. HPV is estimated to be among the most common sexually transmitted diseases in humans. HPV is also the causative agent of cervical cancers and other anogenital cancers and is responsible for a significant portion of oropharyngeal cancers. While sexual transmission is well documented, vertical and non-sexual transmission may also be important. Methods Using recombinant HPV16 particles (quasivirions) and authentic HPV16 grown in three-dimensional organotypic human epithelial culture, we tested the susceptibility of high-risk HPV to clinical disinfectants. Infectious viral particles were incubated with 11 common clinical disinfectants, appropriate neutralizers were added to inactivate the disinfectant and solutions were filter centrifuged. Changes in the infectivity titres of the disinfectant-treated virus were measured compared with untreated virus. Results HPV16 is a highly resistant virus; more so than other non-enveloped viruses previously tested. The HPV16 quasivirions showed similar resistance to native virions, except for being susceptible to isopropanol, the triple phenolic and the lower concentration peracetic acid-silver (PAA-silver)-based disinfectant. Authentic virus and quasivirus were resistant to glutaraldehyde and ortho-phthalaldehyde and susceptible to hypochlorite and the higher concentration PAA-silver-based disinfectant. Conclusions We present the first disinfectant susceptibility data on HPV16 native virions, which show that commonly used clinical disinfectants, including those used as sterilants in medical and dental healthcare facilities, have no effect on HPV16 infectivity. Policy changes concerning disinfectant use are needed. The unusually high resistance of HPV16 to disinfection supports other data suggesting the possibility of fomite or non-sexual transmission of HPV16. PMID:24500190

  3. Minimizing repolarization-related proarrhythmic risk in drug development and clinical practice.

    PubMed

    Farkas, Attila S; Nattel, Stanley

    2010-03-26

    Proarrhythmia, the development of new or worse arrhythmias in response to drug therapy, is a major limitation to the development and use of new drugs. There are different types of drug-induced proarrhythmia, including long-QT syndrome (LQTS), short-QT syndrome and proarrhythmia related to Na+-channel blockade/conduction impairment. By far the most important form of proarrhythmia at present is drug-induced LQTS and its associated characteristic tachyarrhythmia, torsades de pointes (TdP). TdP arises when cellular action potentials (APs) are excessively prolonged, leading to arrhythmogenic afterdepolarizations, especially early afterdepolarizations (EADs), which trigger complex re-entry in a substrate involving increased transmural dispersion of repolarization. In vitro screening, increasingly involving high-throughput assays, is used to assess potential candidate molecules and eliminate potentially problematic structures at an early stage of development. The most commonly used screening assays assess drug block of the K+ current carried by human ether-à-go-go (hERG) subunits, corresponding to the rapid delayed-rectifier K+ channel, the overwhelmingly most common target of TdP-inducing drugs. In addition, the effects of drugs on AP duration or the in vivo equivalent, QT interval, are often assessed in animal models. Methods available for repolarization-related proarrhythmic risk assessment include in vitro (Langendorff-perfused rabbit or guinea pig hearts) and in vivo models (such as alpha-adrenoceptor-stimulated rabbits, rabbits with reduced repolarization reserve due to block of slow delayed-rectifier current, animals with chronic atrioventricular block or animals with cardiac remodelling caused by congestive heart failure). In silico modelling may be helpful for molecular design of non-hERG blocking candidates and for optimization of compound selection (at the molecular and pharmacological profile levels). Finally, clinical evaluation of effects on

  4. Incidence of and risk factors for cognitive impairment in an early Parkinson disease clinical trial cohort

    PubMed Central

    Uc, E Y.; McDermott, M P.; Marder, K S.; Anderson, S W.; Litvan, I; Como, P G.; Auinger, P; Chou, K L.; Growdon, J C.

    2009-01-01

    Objective: To investigate the incidence of and risk factors for cognitive impairment in a large, well-defined clinical trial cohort of patients with early Parkinson disease (PD). Methods: The Mini-Mental State Examination (MMSE) was administered periodically over a median follow-up period of 6.5 years to participants in the Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism trial and its extension studies. Cognitive impairment was defined as scoring 2 standard deviations below age- and education-adjusted MMSE norms. Results: Cumulative incidence of cognitive impairment in the 740 participants with clinically confirmed PD (baseline age 61.0 ± 9.6 years, Hoehn-Yahr stage 1–2.5) was 2.4% (95% confidence interval: 1.2%–3.5%) at 2 years and 5.8% (3.7%–7.7%) at 5 years. Subjects who developed cognitive impairment (n = 46) showed significant progressive decline on neuropsychological tests measuring verbal learning and memory, visuospatial working memory, visuomotor speed, and attention, while the performance of the nonimpaired subjects (n = 694) stayed stable. Cognitive impairment was associated with older age, hallucinations, male gender, increased symmetry of parkinsonism, increased severity of motor impairment (except for tremor), speech and swallowing impairments, dexterity loss, and presence of gastroenterologic/urologic disorders at baseline. Conclusions: The relatively low incidence of cognitive impairment in the Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism study may reflect recruitment bias inherent to clinical trial volunteers (e.g., younger age) or limitations of the Mini-Mental State Examination–based criterion. Besides confirming known risk factors for cognitive impairment, we identified potentially novel predictors such as bulbar dysfunction and gastroenterologic/urologic disorders (suggestive of autonomic dysfunction) early in the course of the disease. GLOSSARY CI = confidence interval; COWA = Controlled Word Association

  5. A Comparison of Community and Clinic Baby Showers to Promote Safe Sleep for Populations at High Risk for Infant Mortality.

    PubMed

    Ahlers-Schmidt, Carolyn R; Schunn, Christy; Lopez, Venessa; Kraus, Stacey; Blackmon, Sheila; Dempsey, Millicent; Sollo, Natalie

    2016-01-01

    Community baby showers have provided education and free portable cribs to promote safe sleep for high-risk infants. We evaluated knowledge gained at these showers and the effectiveness of holding baby showers at a primary care clinic as an alternative to traditional community venues. Participants at the community venue were more likely to exhibit risk factors associated with unsafe sleep and to report an unsafe sleep location for their infant without the provided portable crib. Following the showers, both groups showed improvement in knowledge and intentions regarding safe sleep. However, to connect with the highest risk groups, showers held at community venues appeared to be preferable to those held at high-risk clinics. PMID:27335991

  6. A Comparison of Community and Clinic Baby Showers to Promote Safe Sleep for Populations at High Risk for Infant Mortality

    PubMed Central

    Ahlers-Schmidt, Carolyn R.; Schunn, Christy; Lopez, Venessa; Kraus, Stacey; Blackmon, Sheila; Dempsey, Millicent; Sollo, Natalie

    2016-01-01

    Community baby showers have provided education and free portable cribs to promote safe sleep for high-risk infants. We evaluated knowledge gained at these showers and the effectiveness of holding baby showers at a primary care clinic as an alternative to traditional community venues. Participants at the community venue were more likely to exhibit risk factors associated with unsafe sleep and to report an unsafe sleep location for their infant without the provided portable crib. Following the showers, both groups showed improvement in knowledge and intentions regarding safe sleep. However, to connect with the highest risk groups, showers held at community venues appeared to be preferable to those held at high-risk clinics. PMID:27335991

  7. Environmental risk factors for clinical malaria: a case-control study in the Grau region of Peru.

    PubMed

    Guthmann, J P; Hall, A J; Jaffar, S; Palacios, A; Lines, J; Llanos-Cuentas, A

    2001-01-01

    The role of environmental risk factors in clinical malaria has been studied mainly in Africa and Asia, few investigations have been carried out in Latin America. Field observations in northern coastal Peru, where the prevalence of malaria is high during the agricultural season, suggested that the risk of disease varied according to the characteristics of the house and the house environment. Environmental determinants of the risk of clinical malaria were therefore investigated through a case-control study: 323 clinical cases of malaria, recruited through community-based active case-finding, and 969 age-, sex- and village-matched controls were recruited into the study over a period of 12 months ending June 1997. Residual spraying of houses in the previous 6 months, living more than 100 m from a canal, a level of education equal to primary school or above and working in agriculture conferred significant protection from the risk of developing clinical malaria. The presence of spaces between the wall and roof in the subject's bedroom (eaves) and a house aged > 4 years statistically significantly increased the risk of disease. Based on these results we discuss possible control measures for malaria in this area of the country.

  8. Alcohol consumption and risk-factors for ischemic heart disease in Chuckchi inhabitants: clinical, biological and population studies.

    PubMed

    Chernobrovkina, T V; Arkavy, J V; Astakhova, T I

    1991-01-01

    Clinical, biochemical and epidemiological research has shown variations of serum enzymatic constellations (relatively high level of GGT in Chuckchi natives compared to nonnative newcomers). This difference leads to different unspecific body resistance to exogenous factors, particularly to histamine-liberators. The GGT system has also been linked to alcohol-induced clinical IHD. Based on these findings patients will be screened for GGT activity, which may serve as a marker for population phenotypes representative of high-risk groups. This deficiency in GGT may indicate a high risk for alcohol-related heart disease.

  9. Clinical Risk Index for Babies (CRIB II) Scoring System in Prediction of Mortality in Premature Babies

    PubMed Central

    Ezz-Eldin, Zahraa Mohamed; Hamid, Tamer A. Abdel; Nabil, Hossam El-Din

    2015-01-01

    Background Clinical Risk Index for Babies scoring system (CRIB II) score is a recently developed tool to predict initial risk of mortality amongst low birth weight babies, the utility of which is scarce in many developing countries. Objective To assess the efficiency of CRIB II score as a tool to predict the risk for neonatal mortality among the LBW babies admitted to neonatal intensive care unit (NICU) at a tertiary care facility Kasr El-Aini paediatric hospital, Cairo, Egypt. Materials and Methods Prospective cohort study design where 113 neonates, admitted during the first 24 hours to the NICU of Kasr El-Aini Hospital, from November 2013 till May 2014 were included. On admission, history taking, neonatal examination, arterial blood gas analysis and variables of CRIB II score were done. Subjects were followed up from admission till discharge or death. Results Male to female ratio was 1.1:1. Gestational age ranged from 25-32 weeks, the birth weight ranged from 700-1500 gm with mean of 1134.5 (± 202). CRIB II score ranged from 1-19 with a mean of 9.9 (± 4.0). The total mortality in the included cohort was 34.5% (31/113). Significant positive correlations were found between gestational age, birth weight, temperature, excess base, CRIB II score and the occurrence of mortality and with progressive increase in mortality with increasing CRIB II score (p=0.001). CRIB II score ≥ 11, gestational age ≤ 28 and birth weight ≤ 1100 were all found to be significantly associated with neonatal mortality. Area under ROC curve for CRIB II, gestational age and birth weight were found to be (0.968, 0.900 and 0.834) respectively. CRIB II score with cutoff point of ≥ 11 was the most sensitive (94.9%) with the predictive value (74.0%) and specificity (82.4%) compared to birth weight and gestational age. CRIB II score showed good calibration to predict neonatal mortality as demonstrated with Hosmer-lemeshow goodness of fit test (p= 0.952). Conclusion CRIB II score is a valid

  10. Clinic-wide intervention lowers financial risk and improves revenue to HIV clinics through fewer missed primary care visits.

    PubMed

    Gardner, Lytt I; Marks, Gary; Wilson, Tracey E; Giordano, Thomas P; Sullivan, Meg; Raper, James L; Rodriguez, Allan E; Keruly, Jeanne; Malitz, Faye

    2015-04-01

    : We calculated the financial impact in 6 HIV clinics of a low-effort retention in care intervention involving brief motivational messages from providers, patient brochures, and posters. We used a linear regression model to calculate absolute changes in kept primary care visits from the preintervention year (2008-2009) to the intervention year (2009-2010). Revenue from patients' insurance was also assessed by clinic. Kept visits improved significantly in the intervention year versus the preintervention year (P < 0.0001). We found a net-positive effect on clinic revenue of +$24,000/year for an average-size clinic (7400 scheduled visits/year). We encourage HIV clinic administrators to consider implementing this low-effort intervention.

  11. Predicting long-term cardiovascular risk using the mayo clinic cardiovascular risk score in a referral population.

    PubMed

    Dhoble, Abhijeet; Lahr, Brian D; Allison, Thomas G; Bailey, Kent R; Thomas, Randal J; Lopez-Jimenez, Francisco; Kullo, Iftikhar J; Gupta, Bhanu; Kopecky, Stephen L

    2014-09-01

    Exercise testing provides valuable information but is rarely integrated to derive a risk prediction model in a referral population. In this study, we assessed the predictive value of conventional cardiovascular risk factors and exercise test parameters in 6,546 consecutive adults referred for exercise testing, who were followed for a period of 8.1 ± 3.7 years for incident myocardial infarction, coronary revascularization, and cardiovascular death. A risk prediction model was developed, and cross-validation of model was performed by splitting the data set into 10 equal random subsets, with model fitting based on 9 of the 10 subsets and testing in of the remaining subset, repeated in all 10 possible ways. The best performing model was chosen based on measurements of model discrimination and stability. A risk score was constructed from the final model, with points assigned for the presence of each predictor based on the regression coefficients. Using both conventional risk factors and exercise test parameters, a total of 9 variables were identified as independent and robust predictors and were included in a risk score. The prognostic ability of this model was compared with that of the Adult Treatment Panel III model using the net reclassification and integrated discrimination index. From the cross-validation results, the c statistic of 0.77 for the final model indicated strong predictive power. In conclusion, we developed, tested, and internally validated a novel risk prediction model using exercise treadmill testing parameters. PMID:25052544

  12. Development of a Simple Clinical Risk Score for Early Prediction of Severe Dengue in Adult Patients

    PubMed Central

    Lee, Ing-Kit; Liu, Jien-Wei; Chen, Yen-Hsu; Chen, Yi-Chun; Tsai, Ching-Yen; Huang, Shi-Yu; Lin, Chun-Yu; Huang, Chung-Hao

    2016-01-01

    % for those with a score of ≥2 points, irrespective of the day of illness onset, suggesting that our simple risk score can be easily implemented in resource-limited countries for early prediction of dengue patients at risk of SD provided that they have rapid dengue confirmed tests. For patients with other acute febrile illnesses or bacterial infections usually have SD risk score of >1. Thus, these scoring algorithms cannot totally replace good clinical judgement of the physician, and most importantly, early differentiating dengue from other febrile illnesses is critical for appropriate monitoring and management. PMID:27138448

  13. Plasma HIV-1 tropism and risk of short-term clinical progression to AIDS or death

    PubMed Central

    Casadellà Fontdevila, Maria; Cozzi-Lepri, Alessandro; Phillips, Andrew; Noguera Julian, Marc; Bickel, Marcus; Sedlacek, Dalibor; Kronborg, Gitte; Lazzarin, Adriano; Zilmer, Kai; Clotet, Bonaventura; Lundgren, Jens D; Paredes, Roger

    2014-01-01

    Introduction It is uncertain if plasma HIV-1 tropism is an independent predictor of short-term risk of clinical progression / death, in addition to the CD4 count and HIV RNA level. We conducted a nested case-control study within EuroSIDA to assess this question amongst people with current HIV RNA level >1000 copies/mL, including both people on ART and those ART naïve. Methods People with an AIDS diagnosis or who died from any causes for whom there was a stored plasma sample with HIV-1 RNA (VL)≥1,000 copies/mL available in the time window of 3–12 months prior to the event were identified. At least one control was selected for each case matched for age, VL and HCV status at the time of sampling. Controls were event-free after a matched duration of time from the date of sampling. Plasma HIV tropism was estimated using 454 and population sequencing (PS). Non-R5 HIV was defined as: (a) ≥2% of sequences with a Geno2Pheno (G2P) FPR≤3.75% by 454, and (b) a G2P FPR≤10% by PS. We also compared CD4 slopes over the 12 months following the date of sampling using a linear mixed model with random intercept according to HIV tropism and ART status. Results The study included 266 subjects, 100 cases and 166 controls, with sample taken on average in 2006; 23% and 24% had non-R5 HIV by 454 and PS respectively. There were 19% women, 25% MSM, 92% Caucasians, 22% HCV+. At the time of sampling, 26% were ART-naïve, 25% had started but were off ART and 49% were receiving ART. The median age, CD4 and viral load was 41 years, 350 cells/mm3 and 4.81 log c/mL, respectively. Baseline characteristics were well balanced by tropism. Factors independently associated with clinical progression or death were female gender (OR=2.12; 95% CI=1.04, 4.36; p=0.038), CD4+ count (OR=0.90 per 100 cells/mm3 higher; 95% CI 0.80, 1.00; p=0.058), being on ART (OR=2.72; 95% CI 1.15, 6.41; p=0.022) and calendar year of sample (OR=0.84 per more recent year; 95% CI=0.77, 0.91; p<0.001). Baseline plasma

  14. Inclusion of Dynamic Clinical Data Improves the Predictive Performance of a 30-Day Readmission Risk Model in Kidney Transplantation

    PubMed Central

    Taber, David J; Palanisamy, Arun P; Srinivas, Titte R; Gebregziabher, Mulugeta; Odeghe, John; Chavin, Kenneth D; Egede, Leonard E; Baliga, Prabhakar K

    2015-01-01

    Background 30-day readmissions (30DRA) are a highly scrutinized measure of healthcare quality and relatively frequent among kidney transplants (KTX). Development of predictive risk models are critical to reducing 30DRA and improving outcomes. Current approaches rely on fixed variables derived from administrative data. These models may not capture clinical evolution that is critical to predicting outcomes. Methods We directed a retrospective analysis towards: 1) developing parsimonious risk models for 30DRA and 2) comparing efficiency of models based on the use of immutable versus dynamic data. Baseline and in-hospital clinical and outcomes data were collected from adult KTX recipients between 2005 – 12. Risk models were developed using backward logistic regression and compared for predictive efficacy using ROC Curves. Results Of 1,147 KTX patients, 123 had 30DRA. Risk factors for 30DRA included recipient comorbidities, transplant factors, and index hospitalization patient level clinical data. The initial fixed variable model included 9 risk factors and was modestly predictive (AUC 0.64, 95% CI 0.58–0.69). The model was parsimoniously reduced to 6 risks, which remained modestly predictive (AUC 0.63, 95% CI 0.58–0.69). The initial predictive model using 13 fixed and dynamic variables was significantly predictive (AUC 0.73, 95% CI 0.67–0.80), with parsimonious reduction to 9 variables maintaining predictive efficacy (AUC 0.73, 95% CI 0.67–0.79). The final model using dynamically evolving clinical data outperformed the model using static variables (p=0.009). Internal validation demonstrated the final model was stable with minimal bias. Conclusion We demonstrate that modeling dynamic clinical data outperformed models utilizing immutable data in predicting 30DRA. PMID:25594549

  15. Risk factors associated with exertional medial tibial pain: a 12 month prospective clinical study

    PubMed Central

    Burne, S; Khan, K; Boudville, P; Mallet, R; Newman, P; Steinman, L; Thornton, E

    2004-01-01

    Objective: To investigate in a military setting the potential role of intrinsic biomechanical and anthropometric risk factors for, and the incidence of, exertional medial tibial pain (EMTP). Methods: A prospective clinical outcome study in a cohort of 122 men and 36 women at the Australian Defence Force Academy. Each cadet underwent measurements of seven intrinsic variables: hip range of motion, leg length discrepancy, lean calf girth, maximum ankle dorsiflexion range, foot type, rear foot alignment, and tibial alignment. Test–retest reliability was undertaken on each variable. A physician recorded any cadet presenting with diagnostic criteria of EMTP. Records were analysed at 12 months for EMTP presentation and for military fitness test results. Results: 23 cadets (12 men, 11 women) met the criteria for EMTP after 12 months, with a cross gender (F/M) odds ratio of 3.1. In men, both internal and external range of hip motion was greater in those with EMTP: left internal (12°, p = 0.000), right internal (8°, p = 0.014), left external (8°, p = 0.042), right external (9°, p = 0.026). Lean calf girth was lower by 4.2% for the right leg (p = 0.040) but by only 2.9% for the left leg (p = 0.141). No intrinsic risk factor was associated with EMTP in women. EMTP was the major cause for non-completion of the run component of the ADFA fitness test in both men and women. Conclusions: Greater internal and external hip range of motion and lower lean calf girth were associated with EMTP in male military cadets. Women had high rates of injury, although no intrinsic factor was identified. Reasons for this sex difference need to be identified. PMID:15273181

  16. Derivation of Candidate Clinical Decision Rules to Identify Infants at Risk for Central Apnea

    PubMed Central

    Cunningham, Pádraig; Merchant, Sabrina; Walker, Nicholas; Heffner, Jacquelyn; Shanholtzer, Lucas; Rothenberg, Stephen J.

    2015-01-01

    BACKGROUND AND OBJECTIVES: Central apnea complicates, and may be the presenting complaint in, bronchiolitis. Our objective was to prospectively derive candidate clinical decision rules (CDRs) to identify infants in the emergency department (ED) who are at risk for central apnea. METHODS: We conducted a prospective observational study over 8 years. The primary outcome was central apnea subsequent to the initial ED visit. Infants were enrolled if they presented with central apnea or bronchiolitis. We excluded infants with obstructive apnea, neonatal jaundice, trauma, or suspected sepsis. We developed 3 candidate CDRs by using 3 techniques: (1) Poisson regression clustered on the individual, (2) classification and regression tree analysis (CART), and (3) a random forest (RF). RESULTS: We analyzed 990 ED visits for 892 infants. Central apnea subsequently occurred in the hospital in 41 (5%) patients. Parental report of apnea, previous history of apnea, congenital heart disease, birth weight ≤2.5 kg, lower weight, and age ≤6 weeks all identified a group at high risk for subsequent central apnea. All CDRs and RFs were 100% sensitive (95% confidence interval [CI] 91%–100%) and had a negative predictive value of 100% (95% CI 99%–100%) for the subsequent apnea. Specificity ranged from 61% to 65% (95% CI 58%–68%) for CDRs based on Poisson models; 65% to 77% (95% CI 62%–90%) for CART; and 81% to 91% (95% CI 78%–92%) for RF models. CONCLUSIONS: All candidate CDRs had a negative predictive value of 100% for subsequent central apnea. PMID:26482666

  17. Specificity of Incident Diagnostic Outcomes in Patients at Clinical High Risk for Psychosis

    PubMed Central

    Webb, Jadon R.; Addington, Jean; Perkins, Diana O.; Bearden, Carrie E.; Cadenhead, Kristin S.; Cannon, Tyrone D.; Cornblatt, Barbara A.; Heinssen, Robert K.; Seidman, Larry J.; Tarbox, Sarah I.; Tsuang, Ming T.; Walker, Elaine F.; McGlashan, Thomas H.; Woods, Scott W.

    2015-01-01

    It is not well established whether the incident outcomes of the clinical high-risk (CHR) syndrome for psychosis are diagnostically specific for psychosis or whether CHR patients also are at elevated risk for a variety of nonpsychotic disorders. We collected 2 samples (NAPLS-1, PREDICT) that contained CHR patients and a control group who responded to CHR recruitment efforts but did not meet CHR criteria on interview (help-seeking comparison patients [HSC]). Incident diagnostic outcomes were defined as the occurrence of a SIPS-defined psychosis or a structured interview diagnosis from 1 of 3 nonpsychotic Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) groups (anxiety, bipolar, or nonbipolar mood disorder), when no diagnosis in that group was present at baseline. Logistic regression revealed that the CHR vs HSC effect did not vary significantly across study for any emergent diagnostic outcome; data from the 2 studies were therefore combined. CHR (n = 271) vs HSC (n = 171) emergent outcomes were: psychosis 19.6% vs 1.8%, bipolar disorders 1.1% vs 1.2%, nonbipolar mood disorders 4.4% vs 5.3%, and anxiety disorders 5.2% vs 5.3%. The main effect of CHR vs HSC was statistically significant (OR = 13.8, 95% CI 4.2–45.0, df = 1, P < .001) for emergent psychosis but not for any emergent nonpsychotic disorder. Sensitivity analyses confirmed these findings. Within the CHR group emergent psychosis was significantly more likely than each nonpsychotic DSM-IV emergent disorder, and within the HSC group emergent psychosis was significantly less likely than most emergent nonpsychotic disorders. The CHR syndrome is specific as a marker for research on predictors and mechanisms of developing psychosis. PMID:26272875

  18. The Validation and Clinical Implementation of BRCAplus: A Comprehensive High-Risk Breast Cancer Diagnostic Assay

    PubMed Central

    Chong, Hansook Kim; Wang, Tao; Lu, Hsiao-Mei; Seidler, Sara; Lu, Hong; Keiles, Steven; Chao, Elizabeth C.; Stuenkel, A. J.; Li, Xiang; Elliott, Aaron M.

    2014-01-01

    Breast cancer is the most commonly diagnosed cancer in women, with 10% of disease attributed to hereditary factors. Although BRCA1 and BRCA2 account for a high percentage of hereditary cases, there are more than 25 susceptibility genes that differentially impact the risk for breast cancer. Traditionally, germline testing for breast cancer was performed by Sanger dideoxy terminator sequencing in a reflexive manner, beginning with BRCA1 and BRCA2. The introduction of next-generation sequencing (NGS) has enabled the simultaneous testing of all genes implicated in breast cancer resulting in diagnostic labs offering large, comprehensive gene panels. However, some physicians prefer to only test for those genes in which established surveillance and treatment protocol exists. The NGS based BRCAplus test utilizes a custom tiled PCR based target enrichment design and bioinformatics pipeline coupled with array comparative genomic hybridization (aCGH) to identify mutations in the six high-risk genes: BRCA1, BRCA2, PTEN, TP53, CDH1, and STK11. Validation of the assay with 250 previously characterized samples resulted in 100% detection of 3,025 known variants and analytical specificity of 99.99%. Analysis of the clinical performance of the first 3,000 BRCAplus samples referred for testing revealed an average coverage greater than 9,000X per target base pair resulting in excellent specificity and the sensitivity to detect low level mosaicism and allele-drop out. The unique design of the assay enabled the detection of pathogenic mutations missed by previous testing. With the abundance of NGS diagnostic tests being released, it is essential that clinicians understand the advantages and limitations of different test designs. PMID:24830819

  19. Neurological Complications after Neonatal Bacteremia: The Clinical Characteristics, Risk Factors, and Outcomes

    PubMed Central

    Chu, Shih-Ming; Hsu, Jen-Fu; Lee, Chiang-Wen; Lien, Reyin; Huang, Hsuan-Rong; Chiang, Ming-Chou; Fu, Ren-Huei; Tsai, Ming-Horng

    2014-01-01

    Background Neonates with bacteremia are at risk of neurologic complications. Relevant information warrants further elucidation. Study Design This was a retrospective cohort study of neonates with bacteremia-related neurologic complications (BNCs) in a tertiary-level neonatal intensive care unit (NICU). A systemic chart review was performed conducted to identify clinical characteristics and outcomes. A cohort of related conditions was constructed as the control group. Logistic regression analysis was used to identify independent risk factors for BNC. Results Of 1037 bacteremia episodes, 36 (3.5%) had BNCs. Twenty-four cases of BNCs were related to meningitis, five were presumed meningitis, and seven occurred after septic shock. The most common causative pathogens were Group B streptococcus (41.7%) and E. coli (16.7%). The major BNCs consisted of seizures (28), hydrocephalus (20), encephalomalacia (11), cerebral infarction (7), subdural empyema (6), ventriculitis (8), and abscess (4). Eight (22.8%) neonates died and six (16.7%) were discharged in critical condition when the family withdrew life-sustaining treatment. Among the 22 survivors, eight had neurologic sequelae upon discharge. After multivariate logistic regression analysis, neonates with meningitis caused by Group B streptococcus (adjusted odds ratio [OR]: 8.90, 95% confidence interval [CI]: 2.20–36.08; p = 0.002) and combined meningitis and septic shock (OR, 5.94; 95% CI: 1.53–23.15; p = 0.010) were independently associated with BNCs. Conclusions Neonates with bacteremia-related neurologic complications are associated with adverse outcomes or sequelae. Better strategies aimed at early detection and reducing the emergence of neurologic complications and aggressive treatment of Group B streptococcus sepsis are needed in neonates with meningitis and septic shock. PMID:25364821

  20. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance.

    PubMed

    Huh, Warner K; Ault, Kevin A; Chelmow, David; Davey, Diane D; Goulart, Robert A; Garcia, Francisco A R; Kinney, Walter K; Massad, L Stewart; Mayeaux, Edward J; Saslow, Debbie; Schiffman, Mark; Wentzensen, Nicolas; Lawson, Herschel W; Einstein, Mark H

    2015-02-01

    In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology or cotesting (cytology in combination with high-risk human papillomavirus [hrHPV] testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective U.S.-based registration study. Thirteen experts, including representatives from the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the U.S. Food and Drug Administration (FDA) for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for health care providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.

  1. Pulmonary Embolism in Ischemic Stroke: Clinical Presentation, Risk Factors, and Outcome

    PubMed Central

    Pongmoragot, Jitphapa; Rabinstein, Alejandro A.; Nilanont, Yongchai; Swartz, Richard H.; Zhou, Limei; Saposnik, Gustavo

    2013-01-01

    Background Limited information is available on the frequency of pulmonary embolism (PE) in patients with an acute ischemic stroke (AIS). We evaluated clinical characteristics, predisposing factors, and outcomes in AIS patients with PE. Methods and Results We included all AIS patients admitted to participating institutions in the Registry of the Canadian Stroke Network. Clinically PE was documented by a physician and confirmed by computed tomography pulmonary angiography within 30 days of the stroke case index. The primary outcome was death or disability at discharge. Secondary outcomes included disposition, length of hospital stay, mortality at 3 months and 1 year. Among 11 287 patients with AIS, PE was found in 89 (0.78%) patients. History of cancer, deep vein thrombosis (DVT)/PE, and DVT during the hospitalization were associated with PE. PE was associated with higher risk of death at 30 days (25.8% versus 13.6%; P<0.001), at 1 year (47.2% versus 24.6%; P<0.001), and disability at discharge (85.4% versus 63.6%; P<0.001). Mean length of stay was longer in stroke patients with PE (36 versus 16 days; P=0.001). After adjusting for age, sex, and stroke severity, PE remained associated with lower survival at 30 days and 1 year, and death or disability at discharge (OR 3.02; 95% CI 1.56 to 5.83). Conclusions In this large cohort study, PE occurred in nearly 1% of AIS patients. PE was more common in patients with severe stroke, history of cancer, previous DVT/PE or acute DVT and associated with lower short‐ and long‐term survival, greater disability, and longer length of stay. PMID:24275627

  2. A Clinical Risk Score to Improve the Diagnosis of Tachycardia-Induced Cardiomyopathy in Childhood.

    PubMed

    Moore, Jeremy P; Wang, Shuo; Albers, Erin L; Salerno, Jack C; Stephenson, Elizabeth A; Shah, Maully J; Pflaumer, Andreas; Czosek, Richard J; Garnreiter, Jason M; Collins, Kathryn; Papez, Andrew L; Sanatani, Shubhayan; Cain, Nicole B; Kannankeril, Prince J; Perry, James C; Mandapati, Ravi; Silva, Jennifer N A; Balaji, Seshadri; Shannon, Kevin M

    2016-10-01

    Tachycardia-induced cardiomyopathy (TIC) is a treatable cause of heart failure in children, but there is little information as to which clinical variables best discriminate TIC from other forms of cardiomyopathy. TIC cases with dilated cardiomyopathy (DC) from 16 participating centers were identified and compared with controls with other forms of DC. Presenting clinical, echocardiographic, and electrocardiographic characteristics were collected. Heart rate (HR) percentile was defined as HR/median HR for age, and PR index as the PR/RR interval. P-wave morphology (PWM) was defined as possible sinus or nonsinus based on a predefined algorithm. Eighty TIC cases and 135 controls were identified. Cases demonstrated lower LV end-diastolic diameter and LV end-systolic diameter than DC controls (4.3 vs 6.5, p <0.001; 7.4 vs 10.9, p <0.001) and were less likely to receive inotropic medication at presentation (p <0.001 for both). Multivariable logistic regression identified HR percentile (OR 2.1 per 10% increase, CI 1.3 to 4.6; p = 0.014), PR index (OR 1.2, CI 1.1 to 1.4; p = 0.004), and nonsinus PWM (OR 104.9, CI 15.2 to 1,659.8; p <0.001) as predictive of TIC status. A risk score using HR percentile >130%, PR index >30%, and nonsinus PWM was associated with a sensitivity of 100% and specificity of 87% for the diagnosis of TIC. Model training and validation area under the curves were similar at 0.97 and 0.94, respectively. In conclusion, pediatric TIC may be accurately discriminated from other forms of DC using simple electrocardiographic parameters. This may allow for rapid diagnosis and early treatment of this condition. PMID:27515893

  3. Risk factors, clinical features and outcome of treatment of work related musculoskeletal disorders in on-site clinics among IT companies in India.

    PubMed

    Sharan, Deepak; Ajeesh, P S; Rameshkumar, R; Jose, Jeena

    2012-01-01

    Workrelated musculoskeletal disorders among the IT professional is a common area of concern worldwide. This study was taken up to analyze the prevalence of risk factors, clinical features and outcome of treatment in onsite clinics in vaious information technology companies in India. Result revealed poor office ergonomics (54%), lack of keyboard tray (25%), lack of mouse tray (35%), lack of foot rest (60%), improper monitor height (80%) were the major self reported risk factors. Major identified MSD were Myofascial Pain Syndrome (49.20%), Thoracic outlet syndrome (25.02%), Fibromyalgia syndrome (8.5%). Majorly affected body regions were neck (64.9%), shoulder (42.1%), lower back (56.5%) and thigh (34.2%). The results were comparable with the literature. Feedback of the participants also revealed most of the participants were well satisfied with SHARAN's protocol.

  4. Noninvasive prenatal testing in routine clinical practice for a high-risk population

    PubMed Central

    Qi, Guijie; Yi, Jianping; Han, Baosheng; Liu, Heng; Guo, Wanru; Shi, Chong; Yin, Lirong

    2016-01-01

    Abstract This study aimed to summarize the effects of noninvasive prenatal testing (NIPT) on aneuploidy among high-risk participants in Tangshan Maternal and Children Health Hospital. NIPT or invasive prenatal diagnosis was recommended to patients with a high risk of fetal aneuploidy from February 2013 to February 2014. Patients who exhibited eligibility and applied for NIPT from January 2012 to January 2013 were included in a comparison group. The rates of patients who underwent invasive testing, declined to undergo further testing, and manifested trisomies 21, 18, and 13 were compared between two groups. Follow-up data were obtained from the participants who underwent NIPT from 2013 to 2014. A total of 7223 patients (3018 and 4205 individuals before and after NIPT) were eligible for analysis. After NIPT was introduced in 2013 to 2014, 727 patients (17.3%) underwent invasive testing, 2828 preferred NIPT (67.3%), and 650 declined to undergo further testing (15.5%). A total of 34 cases of trisomies 21, 18, and 13 (0.8%) were found. In 2012 to 2013, 565 patients (18.7%) underwent invasive testing and 2453 declined to undergo further testing (81.3%). A total of 7 cases of trisomies 21, 18, and 13 were documented (0.2%). Of these cases, 24 were found from NIPT and 10 cases were found from invasive testing. The number of participants who declined to undergo further testing significantly decreased after NIPT was introduced (81.3% vs. 15.5%, P < 0.001). The sensitivity and specificity of NIPT for trisomies 21, 18, and 13 were 100% and 99.9%, respectively. The detection rates of NIPT for trisomies 21, 18, and 13 also significantly increased (0.2% vs. 0.8%, P < 0.001). By contrast, the overall rates of invasive testing remained unchanged (18.7% vs. 17.3%, P = 0.12). The positive predictive values of NIPT for trisomies 21, 18, and 13 were 100%, 83.3%, and 50.0%, respectively. The false positive rates of NIPT were 0% and 0.04%. With NIPT implementation in clinical

  5. Clinical characteristics and mortality risk prediction in children with acute kidney injury

    PubMed Central

    Sadeghi-Bojd, Simin; Noori, Noor Mohammad; Mohammadi, Mehdi; Teimouri, Alireza

    2015-01-01

    Background: Acute kidney injury (AKI) is characterized by a reversible increase in the blood concentration of creatinine and nitrogenous waste products and by the inability of the kidney to regulate fluid and electrolyte homeostasis appropriately. Objective: AKI is a serious condition in critically ill patients. The aim of the study was to determine incidence rate, identify risk factors, and describe the clinical outcome of AKI in the Pediatric Intensive Care Unit (PICU). Materials and Methods: This prospective observational study was conducted in the PICU of a hospital in the South-east Area of Iran (Zahedan City), to study the clinico-etiological profile of AKI (defined according to the AKI network criteria). Over a period of 20 months from April 2012 to December 2014, 303 children were included in the study. Both the groups of patients, those who developed AKI and those who did not develop AKI, were then followed during the course of their hospital stay. Results: There were 303 cases included in the study, with the incidence rate of AKI of 14.9% in PICU. The most common PICU admission diagnoses in AKI were neurologic 85 (%28.05), followed by heart diseases 52 (17.18%) and 31 (10.23%) for respiratory diseases. AKI was 43.5 and 5.4 times more prevalent in renal and endocrine patients compared to those with heart disease respectively. The mortality rate was estimated to be higher in patients with AKI compared to their counterparts (40% vs. 17.8%). Chance of death increased in patients with AKI (odds ratio = 3.04). Conclusion: AKI is a serious problem, but its true incidence is unknown. Understanding the epidemiology of AKI by using of standard definition help us to find high-risk children that are the first step to improve outcomes. The future multiple-center study may benefit by better identifying risk factors and early detection of AKI by using biomarkers novel to prevent the developing of AKI. PMID:26778883

  6. Cardiovascular effects of dipeptidyl peptidase-4 inhibitors: from risk factors to clinical outcomes.

    PubMed

    Scheen, André J

    2013-05-01

    Dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins) are oral incretin-based glucose-lowering agents with proven efficacy and safety in the management of type 2 diabetes mellitus (T2DM). In addition, preclinical data and mechanistic studies suggest a possible additional non-glycemic beneficial action on blood vessels and the heart, via both glucagon-like peptide-1-dependent and glucagon-like peptide-1-independent effects. As a matter of fact, DPP-4 inhibitors improve several cardiovascular risk factors: they improve glucose control (mainly by reducing the risk of postprandial hyperglycemia) and are weight neutral; may lower blood pressure somewhat; improve postprandial (and even fasting) lipemia; reduce inflammatory markers; diminish oxidative stress; improve endothelial function; and reduce platelet aggregation in patients with T2DM. In addition, positive effects on the myocardium have been described in patients with ischemic heart disease. Results of post hoc analyses of phase 2/3 controlled trials suggest a possible cardioprotective effect with a trend (sometimes significant) toward lower incidence of major cardiovascular events with sitagliptin, vildagliptin, saxagliptin, linagliptin, or alogliptin compared with placebo or other active glucose-lowering agents. However, the definite relationship between DPP-4 inhibition and better cardiovascular outcomes remains to be proven. Major prospective clinical trials involving various DPP-4 inhibitors with predefined cardiovascular outcomes are under way in patients with T2DM and a high-risk cardiovascular profile: the Sitagliptin Cardiovascular Outcome Study (TECOS) on sitagliptin, the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction (SAVOR-TIMI) 53 trial on saxagliptin, the Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE) trial on alogliptin, and the Cardiovascular Outcome

  7. Impact of interactions between risk alleles on clinical endpoints in hypertension

    PubMed Central

    Kohli, Samantha; Kumar, Rahul; Gupta, Mohit; Tyagi, Sanjay; Pasha, M A Qadar

    2016-01-01

    Objective Impairment of the renin-angiotensinogen-aldosterone system (RAAS), one of the characteristics of essential hypertension (EH), imbalances vascular homeostasis. Despite inconsistent reports on individual single nucleotide polymorphisms (SNPs) as a major predictor of EH, interactions among RAAS genetic variants are rarely investigated. Methods Using SNP markers, we studied potential interactions between angiotensin 1 converting enzyme (ACE), angiotensinogen (AGT), angiotensin II-type 1 receptor (AGTR1), and α adducin (ADD1) variants and their correlation with clinical endpoints in 545 individuals with hypertension and 400 age- and ethnicity-matched unrelated controls. Generalised multifactor dimensionality reduction (GMDR) analysis identified the models for genotype interaction. Results Although the results on single genes were significant, gene-gene interactions were more reliable and promising as markers in predisposing hypertension. The best models to represent association of multi-locus interactions with augmented hypertension susceptibility were: (a) within gene 4-locus model comprised of AGT SNPs −217G/A, −20A/C, −6G/A and 235M/T (p=0.022, OR 6.1); and (b) between genes 5-locus model comprised of AGT −217G/A, −20A/C, −6G/A, 235M/T and ACE I/D (p=0.05, OR 4.6). Stratification of 4- and 5-locus GMDR models on the basis of risk alleles from ≤1 to ≥7 increased the ORs from 2.8 to 36.1 and from 0.9 to 16.1, respectively. Moreover, compared to ≤1 risk alleles the ≥7 interacting risk alleles in both 4- and 5-locus models showed an increment of 14.2% and 11.1% in systolic blood pressure, 7.7% and 1.1% in diastolic blood pressure, and 10.5% and 5.1% in mean arterial pressure, respectively, in patients. Conclusions Interactions among the genetic loci of RAAS components may be used as a predictor for susceptibility to hypertension. PMID:27326240

  8. Predicting the onset of psychosis in patients at clinical high risk: practical guide to probabilistic prognostic reasoning.

    PubMed

    Fusar-Poli, P; Schultze-Lutter, F

    2016-02-01

    Prediction of psychosis in patients at clinical high risk (CHR) has become a mainstream focus of clinical and research interest worldwide. When using CHR instruments for clinical purposes, the predicted outcome is but only a probability; and, consequently, any therapeutic action following the assessment is based on probabilistic prognostic reasoning. Yet, probabilistic reasoning makes considerable demands on the clinicians. We provide here a scholarly practical guide summarising the key concepts to support clinicians with probabilistic prognostic reasoning in the CHR state. We review risk or cumulative incidence of psychosis in, person-time rate of psychosis, Kaplan-Meier estimates of psychosis risk, measures of prognostic accuracy, sensitivity and specificity in receiver operator characteristic curves, positive and negative predictive values, Bayes' theorem, likelihood ratios, potentials and limits of real-life applications of prognostic probabilistic reasoning in the CHR state. Understanding basic measures used for prognostic probabilistic reasoning is a prerequisite for successfully implementing the early detection and prevention of psychosis in clinical practice. Future refinement of these measures for CHR patients may actually influence risk management, especially as regards initiating or withholding treatment.

  9. Risk estimates for hip fracture from clinical and densitometric variables and impact of database selection in Lebanese subjects.

    PubMed

    Badra, Mohammad; Mehio-Sibai, Abla; Zeki Al-Hazzouri, Adina; Abou Naja, Hala; Baliki, Ghassan; Salamoun, Mariana; Afeiche, Nadim; Baddoura, Omar; Bulos, Suhayl; Haidar, Rachid; Lakkis, Suhayl; Musharrafieh, Ramzi; Nsouli, Afif; Taha, Assaad; Tayim, Ahmad; El-Hajj Fuleihan, Ghada

    2009-01-01

    Bone mineral density (BMD) and fracture incidence vary greatly worldwide. The data, if any, on clinical and densitometric characteristics of patients with hip fractures from the Middle East are scarce. The objective of the study was to define risk estimates from clinical and densitometric variables and the impact of database selection on such estimates. Clinical and densitometric information were obtained in 60 hip fracture patients and 90 controls. Hip fracture subjects were 74 yr (9.4) old, were significantly taller, lighter, and more likely to be taking anxiolytics and sleeping pills than controls. National Health and Nutrition Examination Survey (NHANES) database selection resulted in a higher sensitivity and almost equal specificity in identifying patients with a hip fracture compared with the Lebanese database. The odds ratio (OR) and its confidence interval (CI) for hip fracture per standard deviation (SD) decrease in total hip BMD was 2.1 (1.45-3.05) with the NHANES database, and 2.11 (1.36-2.37) when adjusted for age and body mass index (BMI). Risk estimates were higher in male compared with female subjects. In Lebanese subjects, BMD- and BMI-derived hip fracture risk estimates are comparable to western standards. The study validates the universal use of the NHANES database, and the applicability of BMD- and BMI-derived risk fracture estimates in the World Health Organization (WHO) global fracture risk model, to the Lebanese. PMID:19246223

  10. Risk assessment, genetic counseling, and clinical care for hereditary breast cancer.

    PubMed

    Powers, Jacquelyn; Stopfer, Jill Elise

    2014-01-01

    During the last 30 years, key advances in the field of cancer genetics have improved identification of high-risk families in which cancer risk can be linked to mutations in cancer susceptible genes. Identification of individuals with heritable cancer risk may influence short- and long-term medical management issues. Heightened screening and risk reducing options can offer lifesaving interventions for the woman and family members who are at risk.

  11. Fractionated total lymphoid irradiation as preparative immunosuppression in high risk renal transplantation: clinical and immunological studies

    SciTech Connect

    Najarian, J.S.; Ferguson, R.M.; Sutherland, D.E.; Slavin, S.; Kim, T.; Kersey, J.; Simmons, R.S.

    1982-10-01

    Twenty-two patients at high risk to reject renal allografts have been treated with fractionated total lymphoid irradiation (FTLI) prior to transplantation of primary (2), secondary (16) or teritary (4) renal allografts. All patients undergoing retransplantation had rapidly rejected previous grafts. At 24 months following transplantation, 72% of grafts were functioning in the TLI group compared with a 38% graft function in an historical control group of recipients receiving secondary or tertiary grafts and treated with conventional immunosuppression. Important variables in determining success of transplantation following fractionated TLI include the dose of TLI, the interval from radiation to transplantation, and maintenance, post-transplant immunosuppressive therapy. Optimal results were achieved with 2500 rads delivered in 100 rad fractions followed by transplantation within two weeks, and a tapering prednisone schedule and maintenance azathioprine post-transplantation. Seventeen patients had significant complications of the radiation treatment and there was one death, prior to transplantation, associated with pneumonitis. In vitro assessment of immune function demonstrated marked peripheral T cell depletion and loss of in vitro responsiveness to mitogen and allogeneic stimulation following FTLI. The administration of donor bone marrow at the time of transplantation did not produce chimerism. The results suggest that when properly utilized FTLI can produce effective adjunctive immunosuppression for clinical transplantation.

  12. Clinical potential of vorapaxar in cardiovascular risk reduction in patients with atherosclerosis.

    PubMed

    Diehl, Philipp; Bode, Christoph; Duerschmied, Daniel

    2015-01-01

    Vorapaxar (ZONTIVITY™, formerly known as SCH 530348) is a specific, orally active antagonist of the protease-activated receptor-1 (PAR-1) on platelets. It inhibits thrombin-induced platelet activation by binding to the ectodomain of PAR-1. After animal studies and Phase II studies showed that vorapaxar sufficiently inhibits platelet activation without significantly increasing bleeding complications, safety and efficacy of vorapaxar were assessed in two large multicenter trials in patients with coronary artery disease and atherosclerosis. The Thrombin-Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndromes (TRACER) trial investigated safety and efficacy of vorapaxar in patients with an acute coronary syndrome without ST-segment elevation. The Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis In Myocardial Infarction 50 (TRA 2°P-TIMI 50) investigated atherothrombotic events in patients with stable atherosclerosis. Results of both studies suggested that vorapaxar given in addition to standard antiplatelet therapy can reduce atherothrombotic events, but increases the risk of mild and moderate bleeding complications. This review article summarizes the main results of TRACER and TRA 2°P-TIMI 50 and suggests patient cohorts that might benefit from treatment with vorapaxar in addition to standard antiplatelet therapy. PMID:26346960

  13. N100 Repetition Suppression Indexes Neuroplastic Defects in Clinical High Risk and Psychotic Youth.

    PubMed

    Gonzalez-Heydrich, Joseph; Enlow, Michelle Bosquet; D'Angelo, Eugene; Seidman, Larry J; Gumlak, Sarah; Kim, April; Woodberry, Kristen A; Rober, Ashley; Tembulkar, Sahil; O'Donnell, Kyle; Hamoda, Hesham M; Kimball, Kara; Rotenberg, Alexander; Oberman, Lindsay M; Pascual-Leone, Alvaro; Keshavan, Matcheri S; Duffy, Frank H

    2016-01-01

    Highly penetrant mutations leading to schizophrenia are enriched for genes coding for N-methyl-D-aspartate receptor signaling complex (NMDAR-SC), implicating plasticity defects in the disease's pathogenesis. The importance of plasticity in neurodevelopment implies a role for therapies that target these mechanisms in early life to prevent schizophrenia. Testing such therapies requires noninvasive methods that can assess engagement of target mechanisms. The auditory N100 is an obligatory cortical response whose amplitude decreases with tone repetition. This adaptation may index the health of plasticity mechanisms required for normal development. We exposed participants aged 5 to 17 years with psychosis (n = 22), at clinical high risk (CHR) for psychosis (n = 29), and healthy controls (n = 17) to an auditory tone repeated 450 times and measured N100 adaptation (mean amplitude during first 150 tones - mean amplitude during last 150 tones). N100 adaptation was reduced in CHR and psychosis, particularly among participants <13 years old. Initial N100 blunting partially accounted for differences. Decreased change in the N100 amplitude with tone repetition may be a useful marker of defects in neuroplastic mechanisms measurable early in life. PMID:26881109

  14. Clinical and Genetic Risk Factors for Suicide under the Influence of Alcohol in a Polish Sample

    PubMed Central

    Fudalej, Sylwia; Ilgen, Mark; Fudalej, Marcin; Wojnar, Marcin; Matsumoto, Halina; Barry, Kristen Lawton; Ploski, Rafal; Blow, Frederic C.

    2009-01-01

    Aims: Despite the large number of suicides that occur with intoxication, little is known about the unique predictors of suicide after alcohol consumption. The goal of this study was to examine clinical and genetic risk factors for alcohol-related suicide. Methods: Data on 162 suicide victims were obtained from post-mortem examinations, police and prosecution inquiries, autopsy protocols and available medical records. Four single nucleotide polymorphisms in the central serotonin system and the renin–angiotensin system related genes previously found to be associated with suicide, alcohol dependence or depression were genotyped. Results: The strongest predictor of suicide under the influence of alcohol was alcohol dependence (OR = 4.63). Those who did not drink alcohol before suicide were more likely to have a diagnosis of major depressive disorder in their medical record and more often had the TT genotype of the tryptophan hydroxylase 2 gene. Conclusions: Suicide under the influence of alcohol is strongly connected with alcohol dependence. The TPH2 gene may play an important role in suicide vulnerability especially in individuals who did not drink alcohol before suicide. PMID:19734157

  15. Meta-cognition is associated with cortical thickness in youth at clinical high risk of psychosis.

    PubMed

    Buchy, Lisa; Stowkowy, Jacque; MacMaster, Frank P; Nyman, Karissa; Addington, Jean

    2015-09-30

    Meta-cognition is compromised in people with schizophrenia and people at clinical high risk (CHR) of psychosis. In the current work in a CHR sample, we hypothesized that meta-cognitive functions would correlate with cortical thickness in five brain regions implicated in the pathogenesis of psychosis: inferior and middle frontal cortices, anterior cingulate cortex, superior temporal cortex and insula. Secondly, we hypothesized that similar neural systems would underlie different meta-cognitive functions. Narratives were gathered for 29 youth at CHR of psychosis using a semi-structured interview. Four meta-cognitive functions within the narratives were measured with the Meta-cognition Assessment Scale and regressed on cortical thickness from our a priori regions of interest using FreeSurfer. Mapping statistics from our a priori regions of interest revealed that meta-cognition functions were associated with cortical thickness in inferior and middle frontal gyri, superior temporal cortex and insula. The distribution of cortical thickness was partially similar across the four MAS items. Results confirm our hypothesis that cortical thickness is significantly associated with meta-cognition in brain regions that consistently show gray matter reductions across the schizophrenia spectrum. Evidence for thickness covariation in a variety of regions suggests partial dependence in the neural architecture underlying various meta-cognitive functions in CHR.

  16. Clinical efficacy and safety of arbekacin for high-risk infections in patients with hematological malignancies.

    PubMed

    Miura, Katsuhiro; Nakagawa, Masaru; Takahashi, Hiromichi; Uchino, Yoshihito; Kodaira, Hitomi; Iriyama, Noriyoshi; Sakagami, Masashi; Ohtake, Shimon; Kobayashi, Sumiko; Hojo, Atsuko; Kurita, Daisuke; Kobayashi, Yujin; Kusuda, Machiko; Hirabayashi, Yukio; Hatta, Yoshihiro; Takei, Masami

    2016-03-01

    We performed a clinical trial to investigate the efficacy and safety of arbekacin (ABK), a unique aminoglycoside with activity against methicillin-resistant Staphylococcus aureus (MRSA), in patients with hematological malignancies complicated by high-risk infections. ABK was administered intravenously at a dose of approximately 5 mg/kg with various broad-spectrum β-lactams, followed by therapeutic drug monitoring (TDM). A total of 54 febrile or infectious episodes were registered, and TDM was performed in 44 (81%) cases. The absolute neutrophil count was below 500/μl in 49 (91%) cases, and cytotoxic chemotherapy was being administered in 47 (87%) cases. Before initiation of ABK, 52 (96%) patients had received fluoroquinolones (n = 37) and/or broad-spectrum β-lactams (n = 34). There were 10 cases of documented infections including one of MRSA pneumonia, and 44 cases of febrile neutropenia. The efficacy at the end of treatment was 80% for all patients, and efficacy was significantly higher in patients attaining maximum concentrations ≥ 16 µg/ml or receiving TDM-guided dose-adjustment of ABK (n = 19, 95 vs. 71%, P = 0.039). Renal toxicity was observed in six cases (11%) but was generally acceptable. This study demonstrated that TDM-guided ABK administration may be applicable under limited conditions for patients with hematological malignancies.

  17. N100 Repetition Suppression Indexes Neuroplastic Defects in Clinical High Risk and Psychotic Youth.

    PubMed

    Gonzalez-Heydrich, Joseph; Enlow, Michelle Bosquet; D'Angelo, Eugene; Seidman, Larry J; Gumlak, Sarah; Kim, April; Woodberry, Kristen A; Rober, Ashley; Tembulkar, Sahil; O'Donnell, Kyle; Hamoda, Hesham M; Kimball, Kara; Rotenberg, Alexander; Oberman, Lindsay M; Pascual-Leone, Alvaro; Keshavan, Matcheri S; Duffy, Frank H

    2016-01-01

    Highly penetrant mutations leading to schizophrenia are enriched for genes coding for N-methyl-D-aspartate receptor signaling complex (NMDAR-SC), implicating plasticity defects in the disease's pathogenesis. The importance of plasticity in neurodevelopment implies a role for therapies that target these mechanisms in early life to prevent schizophrenia. Testing such therapies requires noninvasive methods that can assess engagement of target mechanisms. The auditory N100 is an obligatory cortical response whose amplitude decreases with tone repetition. This adaptation may index the health of plasticity mechanisms required for normal development. We exposed participants aged 5 to 17 years with psychosis (n = 22), at clinical high risk (CHR) for psychosis (n = 29), and healthy controls (n = 17) to an auditory tone repeated 450 times and measured N100 adaptation (mean amplitude during first 150 tones - mean amplitude during last 150 tones). N100 adaptation was reduced in CHR and psychosis, particularly among participants <13 years old. Initial N100 blunting partially accounted for differences. Decreased change in the N100 amplitude with tone repetition may be a useful marker of defects in neuroplastic mechanisms measurable early in life.

  18. N100 Repetition Suppression Indexes Neuroplastic Defects in Clinical High Risk and Psychotic Youth

    PubMed Central

    Gonzalez-Heydrich, Joseph; Bosquet Enlow, Michelle; D'Angelo, Eugene; Seidman, Larry J.; Gumlak, Sarah; Kim, April; Woodberry, Kristen A.; Rober, Ashley; Tembulkar, Sahil; O'Donnell, Kyle; Hamoda, Hesham M.; Kimball, Kara; Rotenberg, Alexander; Oberman, Lindsay M.; Pascual-Leone, Alvaro; Keshavan, Matcheri S.; Duffy, Frank H.

    2016-01-01

    Highly penetrant mutations leading to schizophrenia are enriched for genes coding for N-methyl-D-aspartate receptor signaling complex (NMDAR-SC), implicating plasticity defects in the disease's pathogenesis. The importance of plasticity in neurodevelopment implies a role for therapies that target these mechanisms in early life to prevent schizophrenia. Testing such therapies requires noninvasive methods that can assess engagement of target mechanisms. The auditory N100 is an obligatory cortical response whose amplitude decreases with tone repetition. This adaptation may index the health of plasticity mechanisms required for normal development. We exposed participants aged 5 to 17 years with psychosis (n = 22), at clinical high risk (CHR) for psychosis (n = 29), and healthy controls (n = 17) to an auditory tone repeated 450 times and measured N100 adaptation (mean amplitude during first 150 tones − mean amplitude during last 150 tones). N100 adaptation was reduced in CHR and psychosis, particularly among participants <13 years old. Initial N100 blunting partially accounted for differences. Decreased change in the N100 amplitude with tone repetition may be a useful marker of defects in neuroplastic mechanisms measurable early in life. PMID:26881109

  19. Quarter and cow risk factors associated with the occurrence of clinical mastitis in dairy cows in the united Kingdom

    PubMed Central

    Breen, J. E.; Green, M. J.; Bradley, A. J.

    2009-01-01

    Quarter and cow risk factors associated with the development of clinical mastitis (CM) during lactation were investigated during a 12-mo longitudinal study on 8 commercial Holstein-Friesian dairy farms in the southwest of England. The individual risk factors studied on 1,677 cows included assessments of udder and leg hygiene, teat-end callosity, and hyperkeratosis; body condition score; and measurements of monthly milk quality and yield. Several outcome variables for CM were used for statistical analysis, which included use of generalized linear mixed models. Significant covariates associated with an increased risk of CM were increasing parity, decreasing month of lactation, cows with very dirty udders, and quarters with only very severe hyperkeratosis of the teat-end. Thin and moderate smooth teat-end callosity scores were not associated with an increased risk for CM. Cows that recorded a somatic cell count >199,000 cells/mL and a milk protein percentage <3.2 at the first milk recording after calving were significantly more likely to develop CM after the first 30 d of lactation. There was no association between cow body condition score and incidence of CM. Of the cases of CM available for culture, 171 (26.7%) were confirmed as being caused by Escherichia coli and 121 (18.9%) confirmed as being caused by Streptococcus uberis. Quarters with moderate and very severe hyperkeratosis of the teat-end were at significantly increased risk of clinical E. coli mastitis before the next visit. Quarters with very severe hyperkeratosis of the teat-end were significantly more likely to develop clinical Strep. uberis mastitis before the next visit. There were strong trends within the data to suggest an association between very dirty udders (an increased risk of clinical E. coli mastitis) and teat-ends with no callosity ring present (an increased risk of clinical Strep. uberis mastitis). These results highlight the importance of individual quarter- and cow-level risk factors in

  20. Clinically important improvement in function is common in people with or at high risk of knee OA: the MOST study

    PubMed Central

    White, Daniel K.; Keysor, Julie J.; LaValley, Michael P.; Lewis, Cora E.; Torner, James C.; Nevitt, Michael C.; Felson, David T.

    2010-01-01

    To calculate the frequency of clinically important improvement in function over 30 months and identify risk factors in people who have or are at risk of knee OA. Subjects were from MOST, a longitudinal study of persons with or at high risk of knee OA. We defined Minimal Clinically Important Improvement (MCII) with WOMAC physical function using three different methods. Baseline risk factors tested for improvement included age, gender, educational attainment, presence of radiographic knee OA (ROA), the number of comorbidities, Body Mass Index (BMI), knee pain, walking speed, isokinetic knee extensor strength, depressive symptoms, physical activity, and medication usage. We used logistic regression to evaluate the association of baseline risk factors with MCII. Of the 1801 subjects (age= 63, BMI= 31, 63% female), most had mild limitations in baseline function (WOMAC = 19 +/− 11). Regardless how defined, a substantial percentage of subjects (24%–39%) reached MCII at 30 months. Compared to their counterparts, people with MCII were less likely to have ROA and to use medications, and were more likely to have a lower BMI, less knee pain, a faster walking speed, more knee strength, and fewer depressive symptoms. After adjustment, MCII was 40% to 50% less likely in those with ROA, and 1.9 to 2.0 times more likely in those walking 1.0 m/s faster than counterparts. Clinically important improvement is frequent in people with or at high risk of knee OA. The absence of ROA and a faster walking speed appear to be associated with clinically important improvements. PMID:20395640

  1. Does a too risk-averse approach to the implementation of new radiotherapy technologies delay their clinical use?

    PubMed Central

    Nyström, H; Fiorino, C; Thwaites, D

    2015-01-01

    Radiotherapy is a generally safe treatment modality in practice; nevertheless, recent well-reported accidents also confirm its potential risks. However, this may obstruct or delay the introduction of new technologies and treatment strategies/techniques into clinical practice. Risks must be addressed and judged in a realistic context: risks must be assessed realistically. Introducing new technology may introduce new possibilities of errors. However, delaying the introduction of such new technology therefore means that patients are denied the potentially better treatment opportunities. Despite the difficulty in quantitatively assessing the risks on both sides of the possible choice of actions, including the “lost opportunity”, the best estimates should be included in the overall risk–benefit and cost–benefit analysis. Radiotherapy requires a sufficiently high level of support for the safety, precision and accuracy required: radiotherapy development and implementation is exciting. However, it has been anxious with a constant awareness of the consequences of mistakes or misunderstandings. Recent history can be used to show that for introduction of advanced radiotherapy, the risk-averse medical physicist can act as an electrical fuse in a complex circuit. The lack of sufficient medical physics resource or expertise can short out this fuse and leave systems unsafe. Future technological developments will continue to present further safety and risk challenges. The important evolution of radiotherapy brings different management opinions and strategies. Advanced radiotherapy technologies can and should be safely implemented in as timely a manner as possible for the patient groups where clinical benefit is indicated. PMID:25993488

  2. Improving risk assessment of violence among military Veterans: An evidence-based approach for clinical decision-making

    PubMed Central

    Elbogen, Eric B.; Fuller, Sara; Johnson, Sally C.; Brooks, Stephanie; Kinneer, Patricia; Calhoun, Patrick; Beckham, Jean C.

    2010-01-01

    Despite increased media attention on violent acts against others committed by military Veterans, few models have been developed to systematically guide violence risk assessment among Veterans. Ideally, a model would identify which Veterans are most at risk for violence and increased attention could then be turned to determining what could be done to prevent violent behavior. This article suggests how empirical approaches to risk assessment used successfully in civilian populations can be applied to Veterans. A review was conducted of the scientific literature on Veteran populations regarding factors related to interpersonal violence generally and to domestic violence specifically. A list was then generated of empirically-supported risk factors for clinicians to consider in practice. To conceptualize how these known risk factors relate to a Veteran’s violence potential, risk assessment scholarship was utilized to develop an evidence-based method to guide mental health professionals. The goals of this approach are to integrate science into practice, overcome logistical barriers, and permit more effective assessment, monitoring, and management of violence risk for clinicians working with Veterans, both in Veteran Administration settings and in the broader community. It is likely that the use of a systematic, empirical framework could lead to improved clinical decision-making in the area of risk assessment, and help reduce violence among Veterans. PMID:20627387

  3. BRAF-V600E expression in precursor versus differentiated dendritic cells defines clinically distinct LCH risk groups.

    PubMed

    Berres, Marie-Luise; Lim, Karen Phaik Har; Peters, Tricia; Price, Jeremy; Takizawa, Hitoshi; Salmon, Hélène; Idoyaga, Juliana; Ruzo, Albert; Lupo, Philip J; Hicks, M John; Shih, Albert; Simko, Stephen J; Abhyankar, Harshal; Chakraborty, Rikhia; Leboeuf, Marylene; Beltrão, Monique; Lira, Sérgio A; Heym, Kenneth M; Bigley, Venetia; Collin, Matthew; Manz, Markus G; McClain, Kenneth; Merad, Miriam; Allen, Carl E

    2014-04-01

    Langerhans cell histiocytosis (LCH) is a clonal disorder with elusive etiology, characterized by the accumulation of CD207(+) dendritic cells (DCs) in inflammatory lesions. Recurrent BRAF-V600E mutations have been reported in LCH. In this study, lesions from 100 patients were genotyped, and 64% carried the BRAF-V600E mutation within infiltrating CD207(+) DCs. BRAF-V600E expression in tissue DCs did not define specific clinical risk groups but was associated with increased risk of recurrence. Strikingly, we found that patients with active, high-risk LCH also carried BRAF-V600E in circulating CD11c(+) and CD14(+) fractions and in bone marrow (BM) CD34(+) hematopoietic cell progenitors, whereas the mutation was restricted to lesional CD207(+) DC in low-risk LCH patients. Importantly, BRAF-V600E expression in DCs was sufficient to drive LCH-like disease in mice. Consistent with our findings in humans, expression of BRAF-V600E in BM DC progenitors recapitulated many features of the human high-risk LCH, whereas BRAF-V600E expression in differentiated DCs more closely resembled low-risk LCH. We therefore propose classification of LCH as a myeloid neoplasia and hypothesize that high-risk LCH arises from somatic mutation of a hematopoietic progenitor, whereas low-risk disease arises from somatic mutation of tissue-restricted precursor DCs.

  4. Risk factors and clinical characteristics of in-hospital death in acute myocardial infarction with IABP support

    PubMed Central

    Cao, Jianing; Liu, Wenxian; Zhu, Jiajia; Zhao, Han

    2015-01-01

    Background: Despite the widespread use of the intra-aortic balloon pump (IABP) in acute myocardial infarction (AMI), there were few clinical trials regarding the deceased’s feature. Therefore, we conducted a study to investigate the clinical characteristics and risk factor led to in-hospital deaths among AMI patients with IABP support. Objective: To investigate the clinical characteristics and risk factors of in-hospital death with IABP support in AMI patients. Methods: The clinical data of 572 consecutive IABP supported patients with AMI within 72 hours from symptom onset from July 2005 to July 2013 were retrospectively analyzed. The evolution of the risk factors of in-hospital death and clinical characteristics was compared in 81 non-survivors and the survivors. Results: Non-survivors had a more severe clinical profile at admission. Fewer patients were treated with emergency reperfusion therapy in the non-survivors group. Cardiogenic shock, Mechanical complications, ventricular tachycardia/fibrillation and MODS were much common in non-survivors (P<0.001). Multivariate logistic regression analysis showed advanced age (>65 years), prolonged time from symptom onset to first medical contact (FMC), Killip class III/IV, renal dysfunction(GFR <60 ml/min/1.73 m2), and left ventricular ejection fraction (LVEF) <30% were risk factors associated with higher in-hospital mortality. Conclusions: IABP support may be more effective combined with revascularization for AMI patients whose hemodynamics is compromised. Patients accompanied with cardiogenic shock and other life-threatening complications are often uselesswith IABP support. Meanwhile, patient whose hemodynamics parameters have significant response to IABP may get benefits with IABP to improve in-hospital survival. PMID:26221368

  5. Sexual Health Outcomes at 24 Months for a Clinic-Linked Intervention to Prevent Pregnancy Risk Behaviors

    PubMed Central

    Sieving, Renee E.; McRee, Annie-Laurie; McMorris, Barbara J.; Beckman, Kara J.; Pettingell, Sandra L.; Bearinger, Linda H.; Garwick, Ann W.; Oliphant, Jennifer A.; Plowman, Shari; Resnick, Michael D.; Secor-Turner, Molly

    2015-01-01

    Importance Preventing early pregnancy among vulnerable adolescents requires innovative and sustained approaches. Prime Time, a youth development intervention, aims to reduce pregnancy risk among adolescent girls seeking clinic services who are at high risk for pregnancy. Objective To evaluate sexual risk behaviors and related outcomes with a 24-month postbaseline survey, 6 months after the conclusion of the Prime Time intervention. Design Randomized controlled trial. Setting Community and school-based primary care clinics. Participants Of 253 sexually active 13- to 17-year-old girls meeting specified risk criteria, 236 (93.3%) completed the 24-month follow-up survey. Intervention Offered during an 18-month period, Prime Time includes case management and youth leadership programs. Main Outcome Measures Self-reported consistency of condom, hormonal, and dual-method contraceptive use with most recent male sex partner and number of male sex partners in the past 6 months. Results At 24-month follow-up, the intervention group reported significantly more consistent use of condoms, hormonal contraception, and dual-method contraception than the control group. Intervention participants also reported improvements in family connectedness and self-efficacy to refuse unwanted sex, and reductions in the perceived importance of having sex. No between-group differences were found in the number of recent male sex partners. Conclusions and Relevance This study contributes to what has been a dearth of evidence regarding youth development interventions offered through clinic settings, where access to high-risk adolescents is plentiful but few efforts have emphasized a dual approach of strengthening sexual and nonsexual protective factors while addressing risk. Findings suggest that health services grounded in a youth development framework can lead to long-term reductions in sexual risk among vulnerable youth. PMID:23440337

  6. Clinical diseases with thrombotic risk and their pharmacologycal treatment: How they change the therapeutic attitude in dental treatments

    PubMed Central

    Martínez-López, Federico; Arrieta-Blanco, Juan J.; Oñate-Cabrerizo, Daniel; Cabrerizo-Merino, Maria C.

    2013-01-01

    The new antiplatelets and anticoagulant drugs have been recently introduced in the daily medical practices for the control of thromboembolism associated with different diseases. The dental assistance of these patients forces us to know these drugs, understand their action mechanisms and try to decrease the risks that entail ours actions in these patients, making a thorough analysis of the risk of bleeding that is going to be related to our medical intervention, as well as the use of all the control measures of the hemorrhage from our knowledge with these patients, and to be prudent. The communication with the medical specialist that supervises these patients must be maxim, being necessary to make clinic trials for establishing protocols or guides of the handling with these patients during the odontological treatment. Key words:Antiplatelet drugs, anticoagulants drugs, new/classic, thrombotic risk, hemorrhagic risk, dental treatment, caution. PMID:24121924

  7. Identifying unique and shared risk factors for physical intimate partner violence and clinically-significant physical intimate partner violence.

    PubMed

    Slep, Amy M Smith; Foran, Heather M; Heyman, Richard E; Snarr, Jeffery D; Usaf Family Advocacy Research Program

    2014-12-01

    Intimate partner violence (IPV) is a significant public health concern. To date, risk factor research has not differentiated physical violence that leads to injury and/or fear (i.e., clinically significant IPV; CS-IPV) from general physical IPV. Isolating risk relations is necessary to best inform prevention and treatment efforts. The current study used an ecological framework and evaluated relations of likely risk factors within individual, family, workplace, and community levels with both CS-IPV and general IPV to determine whether they were related to one type of IPV, both, or neither for both men and women. Probable risk and promotive factors from multiple ecological levels of influence were selected from the literature and assessed, along with CS-IPV and general IPV, via an anonymous, web-based survey. The sample comprised US Air Force (AF) active duty members and civilian spouses (total N = 36,861 men; 24,331 women) from 82 sites worldwide. Relationship satisfaction, age, and alcohol problems were identified as unique risk factors (in the context of the 23 other risk factors examined) across IPV and CS-IPV for men and women. Other unique risk factors were identified that differed in prediction of IPV and CS-IPV. The results suggest a variety of both established and novel potential foci for indirectly targeting partner aggression and clinically-significant IPV by improving people's risk profiles at the individual, family, workplace, and community levels. Aggr. Behav. 9999:XX-XX, 2014. © 2014 Wiley Periodicals, Inc. PMID:25474230

  8. Identifying unique and shared risk factors for physical intimate partner violence and clinically-significant physical intimate partner violence.

    PubMed

    Slep, Amy M Smith; Foran, Heather M; Heyman, Richard E; Snarr, Jeffery D; Usaf Family Advocacy Research Program

    2015-05-01

    Intimate partner violence (IPV) is a significant public health concern. To date, risk factor research has not differentiated physical violence that leads to injury and/or fear (i.e., clinically significant IPV; CS-IPV) from general physical IPV. Isolating risk relations is necessary to best inform prevention and treatment efforts. The current study used an ecological framework and evaluated relations of likely risk factors within individual, family, workplace, and community levels with both CS-IPV and general IPV to determine whether they were related to one type of IPV, both, or neither for both men and women. Probable risk and promotive factors from multiple ecological levels of influence were selected from the literature and assessed, along with CS-IPV and general IPV, via an anonymous, web-based survey. The sample comprised US Air Force (AF) active duty members and civilian spouses (total N = 36,861 men; 24,331 women) from 82 sites worldwide. Relationship satisfaction, age, and alcohol problems were identified as unique risk factors (in the context of the 23 other risk factors examined) across IPV and CS-IPV for men and women. Other unique risk factors were identified that differed in prediction of IPV and CS-IPV. The results suggest a variety of both established and novel potential foci for indirectly targeting partner aggression and clinically-significant IPV by improving people's risk profiles at the individual, family, workplace, and community levels. Aggr. Behav. 41:227-241, 2015. © 2014 Wiley Periodicals, Inc. PMID:27541201

  9. Lupus cystitis in Korean patients with systemic lupus erythematosus: risk factors and clinical outcomes.

    PubMed

    Koh, J H; Lee, J; Jung, S M; Ju, J H; Park, S-H; Kim, H-Y; Kwok, S-K

    2015-10-01

    This study was performed to investigate the clinical characteristics of lupus cystitis and determine the risk factors and clinical outcomes of lupus cystitis in patients with systemic lupus erythematosus (SLE). We retrospectively reviewed 1064 patients at Seoul St. Mary's Hospital in Seoul, Korea, from 1998 to 2013. Twenty-four patients had lupus cystitis. Lupus cystitis was defined as unexplained ureteritis and/or cystitis as detected by imaging studies, cystoscopy, or bladder histopathology without urinary microorganisms or stones. Three-fourths of patients with lupus cystitis had concurrent lupus mesenteric vasculitis (LMV). The initial symptoms were gastrointestinal in nature for most patients (79.2%). High-dose methylprednisolone was initially administered to most patients (91.7%) with lupus cystitis. Two patients (8.3%) died of urinary tract infections. Sixty-five age- and sex-matched patients with SLE who were admitted with other manifestations were included as the control group. Patients with lupus cystitis showed a lower C3 level (p = 0.031), higher SLE Disease Activity Index score (p = 0.006), and higher ESR (p = 0.05) upon admission; more frequently had a history of LMV prior to admission (p < 0.001); and less frequently had a history of neuropsychiatric lupus (p = 0.031) than did patients with SLE but without lupus cystitis. The occurrence of lupus cystitis was associated with a history of LMV (OR, 21.794; 95% CI, 4.061-116.963). The median follow-up period was 3.4 years, and the cumulative one-year mortality rate was 20%. Complications developed in 33.3% of patients with lupus cystitis and were related to survival (log-rank p = 0.021). Our results suggest that the possibility of lupus cystitis should be considered when a patient with SLE and history of LMV presents with gastrointestinal symptoms or lower urinary tract symptoms. Development of complications in patients with lupus cystitis can be fatal. Thus, intensive treatment

  10. Risk factors for level V lymph node metastases in solitary papillary thyroid carcinoma with clinically lateral lymph node metastases.

    PubMed

    Yang, Jing; Gong, Yanping; Yan, Shuping; Zhu, Jingqiang; Li, Zhihui; Gong, Rixiang

    2016-08-01

    The extent of lateral neck dissection (LND) in surgical resection of papillary thyroid carcinoma (PTC) with clinically lateral LNM (LLNM) remains controversial. We aimed to explore the frequency of and risk factors for level V LNM in patients with solitary PTC and clinically LLNM. To analyze the frequency and risk factors for level V LNM, we retrospectively reviewed 220 solitary PTC patients who underwent total thyroidectomy, bilateral central neck dissection, and therapeutic LND. LLNM were present in 82.3% patients, and levels II-V LNM were present in 45.9%, 62.7%, 55.5%, and 12.3% patients, respectively. Ipsilateral level V LNM was significantly associated with tumor size >10 mm, extrathyroidal extension, ipsilateral central LNM ratio ≥50%, and contralateral central LNM (CLNM), bilateral CLNM, and simultaneous levels II-IV LNM. Contralateral CLNM was an independent risk factor for level V LNM. In patients with solitary PTC and clinically LLNM, level V LNM was relatively uncommon. Therefore, routine level V lymphadenectomy may be unnecessary in these patients unless level V LNM is suspected on preoperative examination or associated risk factors, especially contralateral CLNM, are present.

  11. Screening schizotypal personality disorder for detection of clinical high risk of psychosis in Chinese mental health services.

    PubMed

    Zhang, TianHong; Li, HuiJun; Tang, YingYing; Li, Hui; Zheng, LiNa; Guo, Qian; Zhao, ShanShan; Zhuo, KaiMing; Qian, ZhenYing; Wang, LanLan; Dai, YunFei; Chow, Annabelle; Li, ChunBo; Jiang, KaiDa; Wang, JiJun; Xiao, ZePing

    2015-08-30

    Schizotypal personality disorder (SPD) is viewed as a marker of prodromal psychosis. However, information regarding genetic risk (e.g. SPD) is often overlooked in the identification process. This study assessed whether SPD screening questionnaire help the prodromal psychosis (also widely applied "clinical high risk" (CHR) for clinical sample) detection in Chinese mental health service. This work also examined whether SPD had higher frequency in genetic risk population and CHR subjects. Two wave studies concerning the SPD identification was used for analysis. Wave 1 survey: 3075 subjects were assessed by Personality Diagnostic Questionnaire for SPD (PDQ-SPD) and Structured Clinical Interview for DSM-IV Axis II (SCID-II). Wave 2 survey: 2113 subjects screened with the prodromal questionnaire -brief version (PQ-B), PDQ-SPD, and interviewed by Structured Interview for Prodromal Symptoms (SIPS). Subjects with family history of mental disorders or with psychosis reported significantly higher scores in SPD. Receiver operating characteristic curves suggested that PDQ-SPD had moderate sensitivity and specificity for identifying CHR subjects. There was significant higher on SPD features in subjects with early stage (Course less than 1 year) of psychosis. Identifying SPD may be useful in early detection of psychosis especially in detecting the genetic risk syndromes and can be integrated with existing prodromal screen tools to improve its efficiency.

  12. Environmental risk assessment of replication competent viral vectors applied in clinical trials: potential effects of inserted sequences.

    PubMed

    van den Akker, Eric; van der Vlugt, Cecile J B; Bleijs, Diederik A; Bergmans, Hans E

    2013-12-01

    Risk assessments of clinical applications involving genetically modified viral vectors are carried out according to general principles that are implemented in many national and regional legislations, e.g., in Directive 2001/18/EC of the European Union. Recent developments in vector design have a large impact on the concepts that underpin the risk assessments of viral vectors that are used in clinical trials. The use of (conditionally) replication competent viral vectors (RCVVs) may increase the likelihood of the exposure of the environment around the patient, compared to replication defective viral vectors. Based on this assumption we have developed a methodology for the environmental risk assessment of replication competent viral vectors, which is presented in this review. Furthermore, the increased likelihood of exposure leads to a reevaluation of what would constitute a hazardous gene product in viral vector therapies, and a keen interest in new developments in the inserts used. One of the trends is the use of inserts produced by synthetic biology. In this review the implications of these developments for the environmental risk assessment of RCVVs are highlighted, with examples from current clinical trials. The conclusion is drawn that RCVVs, notwithstanding their replication competency, can be applied in an environmentally safe way, in particular if adequate built-in safeties are incorporated, like conditional replication competency, as mitigating factors to reduce adverse environmental effects that could occur.

  13. Risk-Taking and Reasons for Living in Non-Clinical Italian University Students

    ERIC Educational Resources Information Center

    Pompili, Maurizio; Lester, David; Innamorati, Marco; Narciso, Valentina; Vento, Alessandro; De Pisa, Eleonora; Tatarelli, Roberto; Girardi, Paolo

    2007-01-01

    The associations between risk-taking, hopelessness, and reasons for living were explored in a sample of 312 Italian students. Respondents completed the Physical Risk Assessment Inventory, the Physical Risk-Taking Behavior Inventory, the Beck Hopelessness Scale, and the Reasons for Living Inventory. Students with lower scores on the Reasons for…

  14. Audit of Cardiovascular Disease Risk Factors among Supported Adults with Intellectual Disability Attending an Ageing Clinic

    ERIC Educational Resources Information Center

    Wallace, Robyn A.; Schluter, Philip

    2008-01-01

    Background: Little is known about the cardiovascular disease (CVD) risk factor profile for older adults with intellectual disability (ID). As many CVD risk factors are treatable by lifestyle changes, confirmation of the risk factor profile for older adults with ID could substantially impact upon preventive health practices for this group. Method:…

  15. Assessing Violence Risk and Psychopathy in Juvenile and Adult Offenders: A Survey of Clinical Practices

    ERIC Educational Resources Information Center

    Viljoen, Jodi L.; McLachlan, Kaitlyn; Vincent, Gina M.

    2010-01-01

    This study surveyed 199 forensic clinicians about the practices that they use in assessing violence risk in juvenile and adult offenders. Results indicated that the use of risk assessment and psychopathy tools was common. Although clinicians reported more routine use of psychopathy measures in adult risk assessments compared with juvenile risks…

  16. Adaptation of a Published Risk Model to Point-of-care Clinical Decision Support Tailored to Local Workflow.

    PubMed

    Sobel, Jeffrey L; Baker, Craig C; Levy, David; Cain, Carol H

    2015-01-01

    Electronic clinical decision support can bring newly published knowledge to the point of care. However, local organizational buy-in, support for team workflows, IT system ease of use and other sociotechnical factors are needed to promote adoption. We successfully implemented a multi-variate cardiac risk stratification model from another institution into ours. We recreated the model and integrated it into our workflow, accessing it from our EHR with patient-specific data and facilitating clinical documentation if the user accepts the model results. Our clinical leaders championed the change and led educational dissemination efforts. We describe the ad-hoc social and technical collaboration needed to build and deploy the tool. The tool complements a clinical initiative within a community of practice, and is correlated with appropriate use of nuclear imaging. PMID:26958255

  17. Prediction of Angiographic Extent of Coronary Artery Disease on the Basis of Clinical Risk Scores in Patients of Unstable Angina

    PubMed Central

    Jain, Anoop; Rathore, Monika

    2015-01-01

    Background The correlation of clinical risk predictors and clinical risk scores: Thrombolysis in Myocardial Infarction (TIMI), Platelet Glycoprotein IIb-IIIa in Unstable Angina, Receptor Suppression Using Integrilin Therapy (PURSUIT) and Global Registry of Acute Coronary Events (GRACE) scores in Unstable Angina with angiographic extent of Coronary Artery Disease (CAD) is not known. Aim To know the correlation of clinical risk scores with angiographic extent of coronary artery disease. Materials and Methods This was a hospital based single centre, cross-sectional, observational, descriptive study conducted at a tertiary care teaching institute. One hundred and sixty patients with acute unstable angina were evaluated for presence of 9 clinical predictors and their 3 risk scores were calculated. All patients underwent coronary angiography. Correlation with Modified Gensini score and percentage stenosis in culprit artery was done. Statistical Analysis Data were summarized in the form of Mean, Standard Deviation and Proportions. Multiple linear regressions, Student’s t-test and Pearson’s coefficient ‘r’ were also used. Results Use of aspirin, age >= 65 years & presence of Congestive Heart Failure (CHF) were stronger predictors of Modified Gensini score. Presence of elevated enzymes and age >65 years were more significant predictors of percentage stenosis of culprit artery. GRACE score had better correlation with Modified Gensini score, PURSUIT score had more correlation with percentage stenosis in culprit artery. Conclusion Use of Aspirin, age >= 65 years, presence of CHF and presence of elevated enzymes are stronger predictors of extent of CAD. Hence we recommend that these factors be given more importance. GRACE and PURSUIT risk scores had more correlation with angiographic extent of CAD. PMID:26672410

  18. Risk assessment models in genetics clinic for array comparative genomic hybridization: Clinical information can be used to predict the likelihood of an abnormal result in patients

    PubMed Central

    Marano, Rachel M.; Mercurio, Laura; Kanter, Rebecca; Doyle, Richard; Abuelo, Dianne; Morrow, Eric M.; Shur, Natasha

    2013-01-01

    Array comparative genomic hybridization (aCGH) testing can diagnose chromosomal microdeletions and duplications too small to be detected by conventional cytogenetic techniques. We need to consider which patients are more likely to receive a diagnosis from aCGH testing versus patients that have lower likelihood and may benefit from broader genome wide scanning. We retrospectively reviewed charts of a population of 200 patients, 117 boys and 83 girls, who underwent aCGH testing in Genetics Clinic at Rhode Island hospital between 1 January/2008 and 31 December 2010. Data collected included sex, age at initial clinical presentation, aCGH result, history of seizures, autism, dysmorphic features, global developmental delay/intellectual disability, hypotonia and failure to thrive. aCGH analysis revealed abnormal results in 34 (17%) and variants of unknown significance in 24 (12%). Patients with three or more clinical diagnoses had a 25.0% incidence of abnormal aCGH findings, while patients with two or fewer clinical diagnoses had a 12.5% incidence of abnormal aCGH findings. Currently, we provide families with a range of 10–30% of a diagnosis with aCGH testing. With increased clinical complexity, patients have an increased probability of having an abnormal aCGH result. With this, we can provide individualized risk estimates for each patient. PMID:27625836

  19. Risk assessment models in genetics clinic for array comparative genomic hybridization: Clinical information can be used to predict the likelihood of an abnormal result in patients.

    PubMed

    Marano, Rachel M; Mercurio, Laura; Kanter, Rebecca; Doyle, Richard; Abuelo, Dianne; Morrow, Eric M; Shur, Natasha

    2013-03-01

    Array comparative genomic hybridization (aCGH) testing can diagnose chromosomal microdeletions and duplications too small to be detected by conventional cytogenetic techniques. We need to consider which patients are more likely to receive a diagnosis from aCGH testing versus patients that have lower likelihood and may benefit from broader genome wide scanning. We retrospectively reviewed charts of a population of 200 patients, 117 boys and 83 girls, who underwent aCGH testing in Genetics Clinic at Rhode Island hospital between 1 January/2008 and 31 December 2010. Data collected included sex, age at initial clinical presentation, aCGH result, history of seizures, autism, dysmorphic features, global developmental delay/intellectual disability, hypotonia and failure to thrive. aCGH analysis revealed abnormal results in 34 (17%) and variants of unknown significance in 24 (12%). Patients with three or more clinical diagnoses had a 25.0% incidence of abnormal aCGH findings, while patients with two or fewer clinical diagnoses had a 12.5% incidence of abnormal aCGH findings. Currently, we provide families with a range of 10-30% of a diagnosis with aCGH testing. With increased clinical complexity, patients have an increased probability of having an abnormal aCGH result. With this, we can provide individualized risk estimates for each patient.

  20. Risk assessment models in genetics clinic for array comparative genomic hybridization: Clinical information can be used to predict the likelihood of an abnormal result in patients.

    PubMed

    Marano, Rachel M; Mercurio, Laura; Kanter, Rebecca; Doyle, Richard; Abuelo, Dianne; Morrow, Eric M; Shur, Natasha

    2013-03-01

    Array comparative genomic hybridization (aCGH) testing can diagnose chromosomal microdeletions and duplications too small to be detected by conventional cytogenetic techniques. We need to consider which patients are more likely to receive a diagnosis from aCGH testing versus patients that have lower likelihood and may benefit from broader genome wide scanning. We retrospectively reviewed charts of a population of 200 patients, 117 boys and 83 girls, who underwent aCGH testing in Genetics Clinic at Rhode Island hospital between 1 January/2008 and 31 December 2010. Data collected included sex, age at initial clinical presentation, aCGH result, history of seizures, autism, dysmorphic features, global developmental delay/intellectual disability, hypotonia and failure to thrive. aCGH analysis revealed abnormal results in 34 (17%) and variants of unknown significance in 24 (12%). Patients with three or more clinical diagnoses had a 25.0% incidence of abnormal aCGH findings, while patients with two or fewer clinical diagnoses had a 12.5% incidence of abnormal aCGH findings. Currently, we provide families with a range of 10-30% of a diagnosis with aCGH testing. With increased clinical complexity, patients have an increased probability of having an abnormal aCGH result. With this, we can provide individualized risk estimates for each patient. PMID:27625836

  1. Risk assessment models in genetics clinic for array comparative genomic hybridization: Clinical information can be used to predict the likelihood of an abnormal result in patients

    PubMed Central

    Marano, Rachel M.; Mercurio, Laura; Kanter, Rebecca; Doyle, Richard; Abuelo, Dianne; Morrow, Eric M.; Shur, Natasha

    2013-01-01

    Array comparative genomic hybridization (aCGH) testing can diagnose chromosomal microdeletions and duplications too small to be detected by conventional cytogenetic techniques. We need to consider which patients are more likely to receive a diagnosis from aCGH testing versus patients that have lower likelihood and may benefit from broader genome wide scanning. We retrospectively reviewed charts of a population of 200 patients, 117 boys and 83 girls, who underwent aCGH testing in Genetics Clinic at Rhode Island hospital between 1 January/2008 and 31 December 2010. Data collected included sex, age at initial clinical presentation, aCGH result, history of seizures, autism, dysmorphic features, global developmental delay/intellectual disability, hypotonia and failure to thrive. aCGH analysis revealed abnormal results in 34 (17%) and variants of unknown significance in 24 (12%). Patients with three or more clinical diagnoses had a 25.0% incidence of abnormal aCGH findings, while patients with two or fewer clinical diagnoses had a 12.5% incidence of abnormal aCGH findings. Currently, we provide families with a range of 10–30% of a diagnosis with aCGH testing. With increased clinical complexity, patients have an increased probability of having an abnormal aCGH result. With this, we can provide individualized risk estimates for each patient.

  2. Mediators of the Relation Between Community Violence and Sexual Risk Behavior Among Adults Attending a Public Sexually Transmitted Infection Clinic.

    PubMed

    Senn, Theresa E; Walsh, Jennifer L; Carey, Michael P

    2016-07-01

    Prior research shows that violence is associated with sexual risk behavior, but little is known about the relation between community violence (i.e., violence that is witnessed or experienced in one's neighborhood) and sexual risk behavior. To better understand contextual influences on HIV risk behavior, we asked 508 adult patients attending a publicly funded STI clinic in the U.S. (54 % male, M age = 27.93, 68 % African American) who were participating in a larger trial to complete a survey assessing exposure to community violence, sexual risk behavior, and potential mediators of the community violence-sexual risk behavior relation (i.e., mental health, substance use, and experiencing intimate partner violence). A separate sample of participants from the same trial completed measures of sexual behavior norms, which were aggregated to create measures of census tract sexual behavior norms. Data analyses controlling for socioeconomic status revealed that higher levels of community violence were associated with more sexual partners for men and with more episodes of unprotected sex with non-steady partners for women. For both men and women, substance use and mental health mediated the community violence-sexual risk behavior relation; in addition, for men only, experiencing intimate partner violence also mediated this relation. These results confirm that, for individuals living in communities with high levels of violence, sexual risk reduction interventions need to address intimate partner violence, substance use, and mental health to be optimally effective.

  3. Natural History of Clinically Staged Low- and Intermediate-Risk Prostate Cancer Treated With Monotherapeutic Permanent Interstitial Brachytherapy

    SciTech Connect

    Taira, Al V.; Merrick, Gregory S.; Galbreath, Robert W.; Wallner, Kent E.; Butler, Wayne M.

    2010-02-01

    Purpose: To evaluate the natural history of clinically staged low- and intermediate-risk prostate cancer treated with permanent interstitial seed implants as monotherapy. Methods and Materials: Between April 1995 and May 2005, 463 patients with clinically localized prostate cancer underwent brachytherapy as the sole definitive treatment. Men who received supplemental external beam radiotherapy or androgen deprivation therapy were excluded. Dosimetric implant quality was determined based on the minimum dose that covered 90% of the target volume and the volume of the prostate gland receiving 100% of the prescribed dose. Multiple parameters were evaluated as predictors of treatment outcomes. Results: The 12-year biochemical progression-free survival (bPFS), cause-specific survival, and overall survival rates for the entire cohort were 97.1%, 99.7%, and 75.4%, respectively. Only pretreatment prostate-specific antigen level, percent positive biopsy cores, and minimum dose that covered 90% of the target volume were significant predictors of biochemical recurrence. The bPFS, cause-specific survival, and overall survival rates were 97.4%, 99.6%, and 76.2%, respectively, for low-risk patients and 96.4%, 100%, and 74.0%, respectively, for intermediate-risk patients. The bPFS rate was 98.8% for low-risk patients with high-quality implants versus 92.1% for those with less adequate implants (p < 0.01), and it was 98.3% for intermediate-risk patients with high-quality implants versus 86.4% for those with less adequate implants (p < 0.01). Conclusions: High-quality brachytherapy implants as monotherapy can provide excellent outcomes for men with clinically staged low- and intermediate-risk prostate cancer. For these men, a high-quality implant can achieve results comparable to high-quality surgery in the most favorable pathologically staged patient subgroups.

  4. Assessment of uncertainties in radiation-induced cancer risk predictions at clinically relevant doses

    SciTech Connect

    Nguyen, J.; Moteabbed, M.; Paganetti, H.

    2015-01-15

    Purpose: Theoretical dose–response models offer the possibility to assess second cancer induction risks after external beam therapy. The parameters used in these models are determined with limited data from epidemiological studies. Risk estimations are thus associated with considerable uncertainties. This study aims at illustrating uncertainties when predicting the risk for organ-specific second cancers in the primary radiation field illustrated by choosing selected treatment plans for brain cancer patients. Methods: A widely used risk model was considered in this study. The uncertainties of the model parameters were estimated with reported data of second cancer incidences for various organs. Standard error propagation was then subsequently applied to assess the uncertainty in the risk model. Next, second cancer risks of five pediatric patients treated for cancer in the head and neck regions were calculated. For each case, treatment plans for proton and photon therapy were designed to estimate the uncertainties (a) in the lifetime attributable risk (LAR) for a given treatment modality and (b) when comparing risks of two different treatment modalities. Results: Uncertainties in excess of 100% of the risk were found for almost all organs considered. When applied to treatment plans, the calculated LAR values have uncertainties of the same magnitude. A comparison between cancer risks of different treatment modalities, however, does allow statistically significant conclusions. In the studied cases, the patient averaged LAR ratio of proton and photon treatments was 0.35, 0.56, and 0.59 for brain carcinoma, brain sarcoma, and bone sarcoma, respectively. Their corresponding uncertainties were estimated to be potentially below 5%, depending on uncertainties in dosimetry. Conclusions: The uncertainty in the dose–response curve in cancer risk models makes it currently impractical to predict the risk for an individual external beam treatment. On the other hand, the ratio

  5. Genetic risk score does not correlate with body mass index of Latina women in a clinical trial.

    PubMed

    Coenen, Kimberly R; Karp, Sharon M; Gesell, Sabina B; Dietrich, Mary S; Morgan, Thomas M; Barkin, Shari L

    2011-10-01

    Obesity disproportionately affects Latina women. Common genetic variants are convincingly associated with body mass index (BMI) and may be used to create genetic risk scores (GRS) for obesity that could define genetically influenced forms of obesity and alter response to clinical trial interventions. The objective of this study was (1) to identify the frequency and effect size of common obesity genetic variants in Latina women; (2) to determine the clinical utility of a GRS for obesity with Latina women participating in a community-based clinical trial. DNA from 85 Latina women was genotyped for eight genetic variants previously associated with BMI in Caucasians, but not yet assessed in Latina populations. The main outcome measure was the correlation of GRS (sum of eight risk alleles) with BMI, waist circumference, and percent body fat. A majority (83%) of participants had a BMI ≥25. Frequency of loci near FTO, MC4R, and GNPDA2 were lower in Latinas than Caucasians. Association of each locus with BMI was lower in Latinas compared to Caucasians with no significant correlations with BMI. We conclude that an eight locus GRS has no clinical utility for explaining obesity or predicting response to intervention in Latina women participating in a clinical trial.

  6. American Society of Clinical Oncology Policy Statement: The Role of the Oncologist in Cancer Prevention and Risk Assessment

    PubMed Central

    Zon, Robin T.; Goss, Elizabeth; Vogel, Victor G.; Chlebowski, Rowan T.; Jatoi, Ismail; Robson, Mark E.; Wollins, Dana S.; Garber, Judy E.; Brown, Powel; Kramer, Barnett S.

    2009-01-01

    Oncologists have a critical opportunity to utilize risk assessment and cancer prevention strategies to interrupt the initiation or progression of cancer in cancer survivors and individuals at high risk of developing cancer. Expanding knowledge about the natural history and prognosis of cancers positions oncologists to advise patients regarding the risk of second malignancies and treatment-related cancers. In addition, as recognized experts in the full spectrum of cancer care, oncologists are afforded opportunities for involvement in community-based cancer prevention activities. Although oncologists are currently providing many cancer prevention and risk assessment services to their patients, economic barriers exist, including inadequate or lack of insurance, that may compromise uniform patient access to these services. Additionally, insufficient reimbursement for existing and developing interventions may discourage patient access to these services. The American Society of Clinical Oncology (ASCO), the medical society representing cancer specialists involved in patient care and clinical research, is committed to supporting oncologists in their wide-ranging involvement in cancer prevention. This statement on risk assessment and prevention counseling, although not intended to be a comprehensive overview of cancer prevention describes the current role of oncologists in risk assessment and prevention; provides examples of risk assessment and prevention activities that should be offered by oncologists; identifies potential opportunities for coordination between oncologists and primary care physicians in prevention education and coordination of care for cancer survivors; describes ASCO's involvement in education and training of oncologists regarding prevention; and proposes improvement in the payment environment to encourage patient access to these services. PMID:19075281

  7. Non-genetic risk factors and their influence on the management of patients in the clinic.

    PubMed

    Álvarez, Teresa; Soto, Immaculada; Astermark, Jan

    2015-02-01

    The development of inhibitors is the most serious iatrogenic complication affecting patients with haemophilia. This complication is associated with impaired vital or functional prognosis, reduced quality of life and increased cost of treatment. The reasons why some patients develop antibodies to factor replacement and others do not remain unclear. It is however clear that inhibitor development results from a complex multifactorial interaction between genetic and non-genetic risk factors. Environmental influences implicated in increasing the risk of inhibitor formation can be viewed as modifiable risk factors. Therefore, identification of the non-genetic risk factors may offer the possibility of personalising haemophilia therapy by modifying treatment strategies in high-risk patients in the critical early phase of factor VIII exposure. In this article, we review the non-genetic factors reported as well as the potential impact of danger signals and the different scores for inhibitor development risk stratification.

  8. A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial

    PubMed Central

    Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

    2015-01-01

    Background/Aims: Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). Methods: This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial’s sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. Results: We included 142 of 231 protocols in the final analysis (concept = 78; ad hoc = 64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval = 0.10–0.58)) than in the concept arm (0.27 (0.06–0.50)), but the difference was not significant (p = 0.67). Limitations: The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. Conclusion: A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines

  9. Association of Thalamic Dysconnectivity and Conversion to Psychosis in Youth and Young Adults at Elevated Clinical Risk

    PubMed Central

    Anticevic, Alan; Haut, Kristen; Murray, John D.; Repovs, Grega; Yang, Genevieve J.; Diehl, Caroline; McEwen, Sarah C.; Bearden, Carrie E.; Addington, Jean; Goodyear, Bradley; Cadenhead, Kristin S.; Mirzakhanian, Heline; Cornblatt, Barbara A.; Olvet, Doreen; Mathalon, Daniel H.; McGlashan, Thomas H.; Perkins, Diana O.; Belger, Aysenil; Seidman, Larry J.; Tsuang, Ming T.; van Erp, Theo G. M.; Walker, Elaine F; Hamann, Stephan; Woods, Scott W; Qiu, Maolin; Cannon, Tyrone D.

    2016-01-01

    IMPORTANCE Severe neuropsychiatric conditions, such as schizophrenia, affect distributed neural computations. One candidate system profoundly altered in chronic schizophrenia involves the thalamocortical networks. It is widely acknowledged that schizophrenia is a neurodevelopmental disorder that likely affects the brain before onset of clinical symptoms. However, no investigation has tested whether thalamocortical connectivity is altered in individuals at risk for psychosis or whether this pattern is more severe in individuals who later develop full-blown illness. OBJECTIVES To determine whether baseline thalamocortical connectivity differs between individuals at clinical high risk for psychosis and healthy controls, whether this pattern is more severe in those who later convert to full-blown illness, and whether magnitude of thalamocortical dysconnectivity is associated with baseline prodromal symptom severity. DESIGN, SETTING, AND PARTICIPANTS In this multicenter, 2-year follow-up, case-control study, we examined 397 participants aged 12–35 years of age (243 individuals at clinical high risk of psychosis, of whom 21 converted to full-blown illness, and 154 healthy controls). The baseline scan dates were January 15, 2010, to April 30, 2012. MAIN OUTCOMES AND MEASURES Whole-brain thalamic functional connectivity maps were generated using individuals’ anatomically defined thalamic seeds, measured using resting-state functional connectivity magnetic resonance imaging. RESULTS Using baseline magnetic resonance images, we identified thalamocortical dysconnectivity in the 243 individuals at clinical high risk for psychosis, which was particularly pronounced in the 21 participants who converted to full-blown illness. The pattern involved widespread hypoconnectivity between the thalamus and prefrontal and cerebellar areas, which was more prominent in those who converted to full-blown illness (t173 = 3.77, P < .001, Hedge g = 0.88). Conversely, there was marked

  10. Maternal dietary fatty acid intake during pregnancy and the risk of preclinical and clinical type 1 diabetes in the offspring.

    PubMed

    Niinistö, Sari; Takkinen, Hanna-Mari; Uusitalo, Liisa; Rautanen, Jenna; Nevalainen, Jaakko; Kenward, Michael G; Lumia, Mirka; Simell, Olli; Veijola, Riitta; Ilonen, Jorma; Knip, Mikael; Virtanen, Suvi M

    2014-03-14

    The aim of the present study was to examine the associations between the maternal intake of fatty acids during pregnancy and the risk of preclinical and clinical type 1 diabetes in the offspring. The study included 4887 children with human leucocyte antigen (HLA)-conferred type 1 diabetes susceptibility born during the years 1997-2004 from the Finnish Type 1 Diabetes Prediction and Prevention Study. Maternal diet was assessed with a validated FFQ. The offspring were observed at 3- to 12-month intervals for the appearance of type 1 diabetes-associated autoantibodies and development of clinical type 1 diabetes (average follow-up period: 4·6 years (range 0·5-11·5 years)). Altogether, 240 children developed preclinical type 1 diabetes and 112 children developed clinical type 1 diabetes. Piecewise linear log-hazard survival model and Cox proportional-hazards regression were used for statistical analyses. The maternal intake of palmitic acid (hazard ratio (HR) 0·82, 95 % CI 0·67, 0·99) and high consumption of cheese during pregnancy (highest quarter v. intermediate half HR 0·52, 95 % CI 0·31, 0·87) were associated with a decreased risk of clinical type 1 diabetes. The consumption of sour milk products (HR 1·14, 95 % CI 1·02, 1·28), intake of protein from sour milk (HR 1·15, 95 % CI 1·02, 1·29) and intake of fat from fresh milk (HR 1·43, 95 % CI 1·04, 1·96) were associated with an increased risk of preclinical type 1 diabetes, and the intake of low-fat margarines (HR 0·67, 95 % CI 0·49, 0·92) was associated with a decreased risk. No conclusive associations between maternal fatty acid intake or food consumption during pregnancy and the development of type 1 diabetes in the offspring were detected. PMID:24589042

  11. Emotional and behavioral symptomatology reported by help-seeking youth at clinical high-risk for psychosis.

    PubMed

    Thompson, Elizabeth; Kline, Emily; Ellman, Lauren M; Mittal, Vijay; Reeves, Gloria M; Schiffman, Jason

    2015-03-01

    Subthreshold psychosis-like experiences are typically the focus of psychosis-risk screening as they are associated with a greater propensity for future illness. Potentially prodromal individuals identified as being at clinical high-risk (CHR), however, report a variety of distressing and impairing mental health symptoms in addition to subthreshold psychosis symptoms, indicating that this population is of clinical interest regardless of whether or not they develop psychosis. In the current study, 90 young people (12-21) seeking mental health services completed the Behavior Assessment System for Children, Second Edition (BASC-2), a broad-range checklist of emotional and behavioral concerns and adaptive skills, followed by the Structured Interview for Psychosis-risk Syndromes to assess psychosis risk. Those who met criteria for CHR (n=35) reported elevated scores across several BASC-2 scales including depression, attention problems, locus of control, and sense of inadequacy compared to help-seeking youth without CHR (n=55). Most of these scales were also elevated compared to general population norms. Further, the CHR group had significantly lower scores on two adaptive scales, self-reliance and relations with parents, indicating more impairment in these domains. Results indicate that young people at CHR experience more pervasive and/or more severe symptomatology across several domains of clinical significance compared to a similar group of help-seeking youth not at CHR. Results from this study aid in the understanding of symptom correlates of CHR status beyond attenuated symptoms that can provide clinical information relevant for treatment. PMID:25638728

  12. A Clinical Prediction Model to Assess Risk for Chemotherapy-Related Hospitalization in Patients Initiating Palliative Chemotherapy

    PubMed Central

    Brooks, Gabriel A.; Kansagra, Ankit J.; Rao, Sowmya R.; Weitzman, James I.; Linden, Erica A.; Jacobson, Joseph O.

    2015-01-01

    IMPORTANCE Chemotherapy-related hospitalizations in patients with advanced cancer are common, distressing, and costly. Methods to identify patients at high risk of chemotherapy toxic effects will permit development of targeted strategies to prevent chemotherapy-related hospitalizations. OBJECTIVE To demonstrate the feasibility of using readily available clinical data to assess patient-specific risk of chemotherapy-related hospitalization. DESIGN, SETTING, AND PARTICIPANTS Nested case-control study conducted from January 2003 through December 2011 at the Mass General/North Shore Cancer Center, a community-based cancer center in north eastern Massachusetts. The parent cohort included 1579 consecutive patients with advanced solid-tumor cancer receiving palliative-intent chemotherapy. Case patients (n = 146) included all patients from the parent cohort who experienced a chemotherapy-related hospitalization. Controls (n = 292) were randomly selected from 1433 patients who did not experience a chemotherapy-related hospitalization. EXPOSURES Putative risk factors for chemotherapy-related hospitalization—including patient characteristics, treatment characteristics, and pretreatment laboratory values—were abstracted from medical records. Multivariable logistic regression was used to model the patient-specific risk of chemotherapy-related hospitalization. MAIN OUTCOMES AND MEASURES Chemotherapy-related hospitalization, as adjudicated by the oncology clinical care team within a systematic quality-assessment program. RESULTS A total of 146 (9.2%) of 1579 patients from the parent cohort experienced a chemotherapy-related hospitalization. In multivariate regression, 7 variables were significantly associated with chemotherapy-related hospitalization: age, Charlson comorbidity score, creatinine clearance, calcium level, below-normal white blood cell and/or platelet count, polychemotherapy (vs monotherapy), and receipt of camptothecin chemotherapy. The median predicted risk of

  13. Role Of The Bureau Of Radiological Health In Assessment Of Risks From Clinical Nuclear Magnetic Resonance (NMR) Procedures

    NASA Astrophysics Data System (ADS)

    Anderson, Mary P.; Athey, T. W.; Phillips, Robert A.

    1982-12-01

    The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act provide for the classification of a medical device intended for human use into one of three regulatory classes based on the extent of control necessary to ensure safety and effectiveness: Class I, General Controls; Class II, Performance Standards; Class III, Premarket Approval. Class III devices are those for which there is insufficient information available to ensure safety and effectiveness through General Controls and Performance Standards alone. New devices such as Nuclear Magnetic Resonance Imaging systems fall under Class III because they were developed after the date of the law's enactment (28 May 1976). Investigational studies involving human subjects undertaken to develop safety and effectiveness data for a post-enactment Class III device come under the Investigational Device Exemption (IDE) Regulation (21 CFR 812). This regulation distinguishes between investigations of devices that pose a significant risk to the human subject and those that do not. A significant risk investigation "presents a potential for serious risk to the health, safety, or welfare of a subject." Procedures for obtaining an IDE differ if the device does or does not pose a significant risk. The sponsor of a clinical trial, and ultimately the Institutional Review Board (IRB), have the primary responsibility to determine whether a certain clinical use of the investigational device represents a significant risk to the subject of the investigation. A finding of significant risk does not mean that a device is too hazardous for clinical studies, but it does mean that a formal application for an IDE must be made to and approved by the Food and Drug Administration (FDA) before a clinical trial can begin. If the device is deemed not to pose a significant risk, unless otherwise notified by FDA, the sponsor is not required to submit an IDE application to FDA. Instead, the sponsor and investigators must satisfy only

  14. Clinical risk prediction for pre-eclampsia in nulliparous women: development of model in international prospective cohort

    PubMed Central

    McCowan, Lesley M E; Dekker, Gustaaf A; Poston, Lucilla; Chan, Eliza H Y; Stewart, Alistair W; Black, Michael A; Taylor, Rennae S; Walker, James J; Baker, Philip N; Kenny, Louise C

    2011-01-01

    Objectives To develop a predictive model for pre-eclampsia based on clinical risk factors for nulliparous women and to identify a subgroup at increased risk, in whom specialist referral might be indicated. Design Prospective multicentre cohort. Setting Five centres in Auckland, New Zealand; Adelaide, Australia; Manchester and London, United Kingdom; and Cork, Republic of Ireland. Participants 3572 “healthy” nulliparous women with a singleton pregnancy from a large international study; data on pregnancy outcome were available for 3529 (99%). Main outcome measure Pre-eclampsia defined as ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg, or both, on at least two occasions four hours apart after 20 weeks’ gestation but before the onset of labour, or postpartum, with either proteinuria or any multisystem complication. Preterm pre-eclampsia was defined as women with pre-eclampsia delivered before 37+0 weeks’ gestation. In the stepwise logistic regression the comparison group was women without pre-eclampsia. Results Of the 3529 women, 186 (5.3%) developed pre-eclampsia, including 47 (1.3%) with preterm pre-eclampsia. Clinical risk factors at 14-16 weeks’ gestation were age, mean arterial blood pressure, body mass index (BMI), family history of pre-eclampsia, family history of coronary heart disease, maternal birth weight, and vaginal bleeding for at least five days. Factors associated with reduced risk were a previous single miscarriage with the same partner, taking at least 12 months to conceive, high intake of fruit, cigarette smoking, and alcohol use in the first trimester. The area under the receiver operating characteristics curve (AUC), under internal validation, was 0.71. Addition of uterine artery Doppler indices did not improve performance (internal validation AUC 0.71). A framework for specialist referral was developed based on a probability of pre-eclampsia generated by the model of at least 15% or an abnormal uterine artery Doppler waveform in a

  15. The Effect of Transition Clinics on Knowledge of Diagnosis and Perception of Risk in Young Adult Survivors of Childhood Cancer

    PubMed Central

    Ganju, Rohit G.; Nanda, Ronica H.; Esiashvili, Natia; Switchenko, Jeffrey M.; Wasilewski-Masker, Karen; Marchak, Jordan G.

    2016-01-01

    Background Improved treatment for pediatric cancers has ensured an evergrowing population of patients surviving into adulthood. The current study evaluated the impact of previous engagement in survivor care on patient knowledge and awareness of health risks as young adults. Procedure Young adult survivors of childhood cancers (N = 93, M age = 23.63 y) were recruited during their annual survivor clinic visit. Participants completed self-reported measures of demographics, treatment knowledge, perception of future health risks, participation in previous survivor care, and neurocognitive functioning. Results In total, 82% of patients (N = 76/93) reported previously participating in survivorship care. These patients were more likely to have knowledge of their radiation treatment (P = 0.034) and more likely to recognize risk for future health effects from their treatment (P = 0.019). Income between $10,000 and $24,999 (odds ratio = 0.168; 95% confidence interval, 0.046–0.616; P = 0.031) was associated with decreased patient knowledge regarding diagnosis. Male sex (odds ratio = 0.324; 95% confidence interval, 0.135–0.777; P = 0.012) was associated with less knowledge of future health risks. Patients with self-reported difficulties on the CCSS-NCQ were more likely to regard their cancer treatment as a future health risk. Conclusion Participation in survivor care plays an important role in imparting information to young adult survivors of pediatric cancer regarding their disease history and risk for future health problems. PMID:26925717

  16. [Cost-effectiveness analysis of preventive methods for occlusal surface according to caries risk: results of a controlled clinical trial].

    PubMed

    Tagliaferro, Elaine Pereira da Silva; Marinho, Daniel Savignon; Pereira, Claudia Cristina de Aguiar; Pardi, Vanessa; Ambrosano, Gláucia Maria Bovi; Meneghim, Marcelo de Castro; Pereira, Antonio Carlos

    2013-11-01

    This study presents the results of a cost-effectiveness analysis in a controlled clinical trial on the effectiveness of a modified glass ionomer resin sealant ( Vitremer, 3M ESPE) and the application of fluoride varnish (Duraphat, Colgate) on occlusal surfaces of first permanent molars in children 6-8 years of age (N = 268), according to caries risk (high versus low). Children were examined semiannually by the same calibrated dentist for 24 months after allocation in six groups: high and low risk controls (oral health education every three months); high and low risk with varnish (oral health education every three months + varnish biannually); and high and low risk with sealant (oral health education every three months + a single application of sealant). Economic analysis showed that sealing permanent first molars of high-risk schoolchildren showed a C/E ratio of US$ 119.80 per saved occlusal surface and an incremental C/E ratio of US$ 108.36 per additional saved occlusal surface. The study concluded that sealing permanent first molars of high-risk schoolchildren was the most cost-effective intervention.

  17. [Cost-effectiveness analysis of preventive methods for occlusal surface according to caries risk: results of a controlled clinical trial].

    PubMed

    Tagliaferro, Elaine Pereira da Silva; Marinho, Daniel Savignon; Pereira, Claudia Cristina de Aguiar; Pardi, Vanessa; Ambrosano, Gláucia Maria Bovi; Meneghim, Marcelo de Castro; Pereira, Antonio Carlos

    2013-11-01

    This study presents the results of a cost-effectiveness analysis in a controlled clinical trial on the effectiveness of a modified glass ionomer resin sealant ( Vitremer, 3M ESPE) and the application of fluoride varnish (Duraphat, Colgate) on occlusal surfaces of first permanent molars in children 6-8 years of age (N = 268), according to caries risk (high versus low). Children were examined semiannually by the same calibrated dentist for 24 months after allocation in six groups: high and low risk controls (oral health education every three months); high and low risk with varnish (oral health education every three months + varnish biannually); and high and low risk with sealant (oral health education every three months + a single application of sealant). Economic analysis showed that sealing permanent first molars of high-risk schoolchildren showed a C/E ratio of US$ 119.80 per saved occlusal surface and an incremental C/E ratio of US$ 108.36 per additional saved occlusal surface. The study concluded that sealing permanent first molars of high-risk schoolchildren was the most cost-effective intervention. PMID:25402241

  18. Patient safety's missing link: using clinical expertise to recognize, respond to and reduce risks at a population level

    PubMed Central

    Hibbert, Peter D.; Healey, Frances; Lamont, Tara; Marela, William M.; Warner, Bruce; Runciman, William B.

    2016-01-01

    Introduction Although incident reporting systems are widespread in health care as a strategy to reduce harm to patients, the focus has been on reporting incidents rather than responding to them. Systems containing large numbers of incidents are uniquely placed to raise awareness of, and then characterize and respond to infrequent, but significant risks. The aim of this paper is to outline a framework for the surveillance of such risks, their systematic analysis, and for the development and dissemination of population-based preventive and corrective strategies using clinical and human factors expertise. Requirements for a population-level response The framework outlines four system requirements: to report incidents; to aggregate them; to support and conduct a risk surveillance, review and response process; and to disseminate recommendations. Personnel requirements include a non-hierarchical multidisciplinary team comprising clinicians and subject-matter and human factors experts to provide interpretation and high-level judgement from a range of perspectives. The risk surveillance, review and response process includes searching of large incident and other databases for how and why things have gone wrong, narrative analysis by clinical experts, consultation with the health care sector, and development and pilot testing of corrective strategies. Criteria for deciding which incidents require a population-level response are outlined. Discussion The incremental cost of a population-based response function is modest compared with the ‘reporting’ element. Combining clinical and human factors expertise and a systematic approach underpins the creation of credible risk identification processes and the development of preventive and corrective strategies. PMID:26573789

  19. Joint impact of clinical and behavioral variables on the risk of unplanned readmission and death after a heart failure hospitalization.

    PubMed

    Padhukasahasram, Badri; Reddy, Chandan K; Li, Yan; Lanfear, David E

    2015-01-01

    Most current methods for modeling rehospitalization events in heart failure patients make use of only clinical and medications data that is available in the electronic health records. However, information about patient-reported functional limitations, behavioral variables and socio-economic background of patients may also play an important role in predicting the risk of readmission in heart failure patients. We developed methods for predicting the risk of rehospitalization in heart failure patients using models that integrate clinical characteristics with patient-reported functional limitations, behavioral and socio-economic characteristics. Our goal was to estimate the predictive accuracy of the joint model and compare it with models that make use of clinical data alone or behavioral and socio-economic characteristics alone, using real patient data. We collected data about the occurrence of hospital readmissions from a cohort of 789 heart failure patients for whom a range of clinical and behavioral characteristics data is also available. We applied the Cox model, four different variants of the Cox proportional hazards framework as well as an alternative non-parametric approach and determined the predictive accuracy for different categories of variables. The concordance index obtained from the joint prediction model including all types of variables was significantly higher than the accuracy obtained from using only clinical factors or using only behavioral, socioeconomic background and functional limitations in patients as predictors. Collecting information on behavior, patient-reported estimates of physical limitations and frailty and socio-economic data has significant value in the predicting the risk of readmissions with regards to heart failure events and can lead to substantially more accurate events prediction models.

  20. Reproductive health services for populations at high risk of HIV: Performance of a night clinic in Tete province, Mozambique

    PubMed Central

    2010-01-01

    Background Different models exist to provide HIV/STI services for most-at-risk populations (MARP). Along the Tete traffic corridor in Mozambique, linking Malawi and Zimbabwe, a night clinic opening between 4 and 10 PM was established targeting female sex workers (FSW) and long-distance truck drivers (LDD). The clinic offers free individual education and counselling, condoms, STI care, HIV testing, contraceptive services and outreach peer education. To evaluate this clinic model, we assessed relevance, service utilisation, efficiency and sustainability. Methods In 2007-2009, mapping and enumeration of FSW and LDD was conducted; 28 key informants were interviewed; 6 focus group discussions (FGD) were held with FSW from Mozambique and Zimbabwe, and LDD from Mozambique and Malawi. Clinic outputs and costs were analysed. Results An estimated 4,415 FSW work in the area, or 9% of women aged 15-49, and on average 66 trucks stay overnight near the clinic. Currently on average, 475 clients/month visit the clinic (43% for contraception, 24% for counselling and testing and 23% for STI care). The average clinic running cost is US$ 1408/month, mostly for human resources. All informants endorsed this clinic concept and the need to expand the services. FGD participants reported high satisfaction with the services and mentioned good reception by the health staff, short waiting times, proximity and free services as most important. Participants were in favour of expanding the range of services, the geographical coverage and the opening times. Conclusions Size of the target population, satisfaction of clients and endorsement by health policy makers justify maintaining a separate clinic for MARP. Cost-effectiveness may be enhanced by broadening the range of SRHR-HIV/AIDS services, adapting opening times, expanding geographical coverage and targeting additional MARP. Long-term sustainability remains challenging and requires private-public partnerships or continued project-based funding

  1. Childhood Sexual Abuse and Sexual Risk Behavior Among Men and Women Attending a Sexually Transmitted Disease Clinic

    PubMed Central

    Senn, Theresa E.; Carey, Michael P.; Vanable, Peter A.; Coury-Doniger, Patricia; Urban, Marguerite A.

    2006-01-01

    Childhood sexual abuse (CSA) is associated with a wide range of negative outcomes. This study investigated the relation between CSA and sexual risk behavior in 827 patients recruited from an STD clinic. Overall, CSA was reported by 53% of women and 49% of men, and was associated with greater sexual risk behavior, including more sexual partners, unprotected sex, and sex trading. Alcohol use for men, and drug use for women, mediated the relation between CSA and the number of partners in the past three months; intimate partner violence mediated the relation between CSA and the number of episodes of unprotected sex in the past three months for women. These results document the prevalence of CSA among patients seeking care for an STD, and can be used to tailor sexual risk-reduction programs for individuals who were sexually abused. PMID:16881780

  2. [Clinical value and measurement of arterial stiffness for the assessment of cardiovascular risk in light of recent results].

    PubMed

    Nemcsik, János; Tislér, András; Kiss, István

    2015-02-01

    Cardiovascular risk stratification is fundamental for the development of effective prevention and therapeutic strategies. Although there are numerous scores and risk tables available, a difference still exists between the estimated and real number of cardiovascular events. Measurement of arterial stiffness can provide additional information to risk stratification. The most widely accepted parameter of arterial stiffness is aortic pulse wave velocity, which has been included in the guideline of the European Society of Hypertension in 2007 and 2013, although American guidelines still omit it. In this review the authors summarize the evidence with regards to the different steps required for clinical application of arterial stiffness measurement and they also discuss the questions that evolved from the methodological variability of different measurement techniques.

  3. 2013 Pharmacology Risk SRP Status Review Comments to Chief Scientist. The Risk of Clinically Relevant Unpredicted Effects of Medication

    NASA Technical Reports Server (NTRS)

    2014-01-01

    On December 5, 2013, the Pharmacology Risk SRP, participants from the JSC, HQ, the NSBRI, and NRESS participated in a WebEx/teleconference. The purpose of the call (as stated in the Statement of Task) was to allow the SRP members to: 1. Receive an update by the HRP Chief Scientist or Deputy Chief Scientist on the status of NASA's current and future exploration plans and the impact these will have on the HRP. 2. Receive an update on any changes within the HRP since the 2012 SRP meeting. 3. Receive an update by the Element or Project Scientist(s) on progress since the 2012 SRP meeting. 4. Participate in a discussion with the HRP Chief Scientist, Deputy Chief Scientist, and the Element regarding possible topics to be addressed at the next SRP meeting.

  4. Expectations of benefit and tolerance to risk of individuals with spinal cord injury regarding potential participation in clinical trials.

    PubMed

    Kwon, Brian K; Ghag, Arvindera; Dvorak, Marcel F; Tetzlaff, Wolfram; Illes, Judy

    2012-12-10

    We conducted a survey of individuals living with spinal cord injury (SCI) to determine their receptivity to participating in clinical trials of drug therapies or stem cell therapies, their anticipation of therapeutic benefits, and their tolerance to risk. A 46-item questionnaire was administered to individuals with cervical or thoracic SCI identified through a provincial database. The average age was 42 years and the individuals were, on average, 5.5 years post-injury. Receptivity to neuroprotective drug trials in the acute setting was very high, but somewhat less so for stem cell trials in the subacute or chronic (current) setting. With respect to expectation of functional benefit, approximately one third of the respondents indicated that they would want a 5-25% chance of achieving some functional recovery if enrolling in a stem cell therapy clinical trial in the current, chronic injury state. Whereas the majority typically would require the risk of spinal cord damage, cancer, infection, and nerve pain from invasive cell transplantation trials to be ≤1%, 15-30% would participate regardless of the risk of these complications. The factors associated with this high risk tolerance were gender (males>females), age (elderly>young), and self-reported knowledge of SCI research (greater knowledge>less knowledge). Injury severity or chronicity did not have a significant correlation with risk tolerance. Whereas previous studies have shown that the understanding of stem cell science is limited among individuals with SCI, here we show that many still have high hopes for the possibility of neurological benefit, are anxious to participate in invasive stem cell trials, and, in many cases, have high tolerance for risk in such trials. Taken together, the data underscore the need for careful communication with individuals with SCI to avoid unrealistic expectations and therapeutic misconception in experimental trials.

  5. Modeling Behavior in a Clinically Diagnostic Sequential Risk-Taking Task

    ERIC Educational Resources Information Center

    Wallsten, Thomas S.; Pleskac, Timothy J.; Lejuez, C. W.

    2005-01-01

    This article models the cognitive processes underlying learning and sequential choice in a risk-taking task for the purposes of understanding how they occur in this moderately complex environment and how behavior in it relates to self-reported real-world risk taking. The best stochastic model assumes that participants incorrectly treat outcome…

  6. A Global View of the Relationships between the Main Behavioural and Clinical Cardiovascular Risk Factors in the GAZEL Prospective Cohort

    PubMed Central

    Meneton, Pierre; Lemogne, Cédric; Herquelot, Eléonore; Bonenfant, Sébastien; Larson, Martin G.; Vasan, Ramachandran S.; Ménard, Joël; Goldberg, Marcel; Zins, Marie

    2016-01-01

    Although it has been recognized for a long time that the predisposition to cardiovascular diseases (CVD) is determined by many risk factors and despite the common use of algorithms incorporating several of these factors to predict the overall risk, there has yet been no global description of the complex way in which CVD risk factors interact with each other. This is the aim of the present study which investigated all existing relationships between the main CVD risk factors in a well-characterized occupational cohort. Prospective associations between 12 behavioural and clinical risk factors (gender, age, parental history of CVD, non-moderate alcohol consumption, smoking, physical inactivity, obesity, hypertension, dyslipidemia, diabetes, sleep disorder, depression) were systematically tested using Cox regression in 10,736 middle-aged individuals free of CVD at baseline and followed over 20 years. In addition to independently predicting CVD risk (HRs from 1.18 to 1.97 in multivariable models), these factors form a vast network of associations where each factor predicts, and/or is predicted by, several other factors (n = 47 with p<0.05, n = 37 with p<0.01, n = 28 with p<0.001, n = 22 with p<0.0001). Both the number of factors associated with a given factor (1 to 9) and the strength of the associations (HRs from 1.10 to 6.12 in multivariable models) are very variable, suggesting that all the factors do not have the same influence within this network. These results show that there is a remarkably extensive network of relationships between the main CVD risk factors which may have not been sufficiently taken into account, notably in preventive strategies aiming to lower CVD risk. PMID:27598908

  7. A Global View of the Relationships between the Main Behavioural and Clinical Cardiovascular Risk Factors in the GAZEL Prospective Cohort.

    PubMed

    Meneton, Pierre; Lemogne, Cédric; Herquelot, Eléonore; Bonenfant, Sébastien; Larson, Martin G; Vasan, Ramachandran S; Ménard, Joël; Goldberg, Marcel; Zins, Marie

    2016-01-01

    Although it has been recognized for a long time that the predisposition to cardiovascular diseases (CVD) is determined by many risk factors and despite the common use of algorithms incorporating several of these factors to predict the overall risk, there has yet been no global description of the complex way in which CVD risk factors interact with each other. This is the aim of the present study which investigated all existing relationships between the main CVD risk factors in a well-characterized occupational cohort. Prospective associations between 12 behavioural and clinical risk factors (gender, age, parental history of CVD, non-moderate alcohol consumption, smoking, physical inactivity, obesity, hypertension, dyslipidemia, diabetes, sleep disorder, depression) were systematically tested using Cox regression in 10,736 middle-aged individuals free of CVD at baseline and followed over 20 years. In addition to independently predicting CVD risk (HRs from 1.18 to 1.97 in multivariable models), these factors form a vast network of associations where each factor predicts, and/or is predicted by, several other factors (n = 47 with p<0.05, n = 37 with p<0.01, n = 28 with p<0.001, n = 22 with p<0.0001). Both the number of factors associated with a given factor (1 to 9) and the strength of the associations (HRs from 1.10 to 6.12 in multivariable models) are very variable, suggesting that all the factors do not have the same influence within this network. These results show that there is a remarkably extensive network of relationships between the main CVD risk factors which may have not been sufficiently taken into account, notably in preventive strategies aiming to lower CVD risk. PMID:27598908

  8. Prolonged breast-feeding: no association with increased risk of clinical malnutrition in young children in Burkina Faso.

    PubMed

    Cousens, S; Nacro, B; Curtis, V; Kanki, B; Tall, F; Traore, E; Diallo, I; Mertens, T

    1993-01-01

    Reported are our findings from a case-control study of the association between prolonged breast-feeding and clinical malnutrition in an urban setting in West Africa. The cases were children aged 12-36 months who had been hospitalized with a diagnosis of clinical malnutrition. Children of a similar age who lived in neighbouring courtyards were recruited as controls. For 152 case-control pairs in which both children were receiving solid foods, non-breast-feeding was associated with an increased risk of clinical malnutrition (crude odds ratio = 2.37; 95% confidence interval = 1.24, 4.55). This association remained statistically significant after controlling for various potentially confounding variables (P = 0.03). Our findings suggest that either prolonged breast-feeding may offer substantial protection against clinical malnutrition in the study population or malnutrition leads mothers to stop breast-feeding. These results are inconsistent with those of a number of workers who have reported that prolonged breast-feeding is associated with an increased risk of malnutrition. This inconsistency might have arisen because of differences in the definition of malnutrition used or because of variations in the quantity and quality of weaning foods available in different settings. We found no evidence to support the hypothesis that prolonged breast-feeding may be detrimental to children.

  9. The role of clinical breast examination in cancer screening for women at average risk: A mini review.

    PubMed

    Brennan, Meagan E

    2016-10-01

    As the debate about the potential benefits and harms of screening mammography continues, it is timely to consider the role of clinical breast examination in screening for women at average risk of breast cancer. This article reviews the results from clinical trials and discusses the varied recommendations around the world. It concludes that the evidence does not support routine clinical breast examination for women participating in screening mammography programs, but there may be a benefit for women not do not have mammographic screening, especially in developing nations where health literacy and 'breast awareness' levels may be lower. This review provides information for clinicians to support women who are making decisions about the increasingly complex issue of breast cancer screening. PMID:27621240

  10. Unguided clinical and actuarial assessment of re-offending risk: a direct comparison with sex offenders in Denmark.

    PubMed

    Bengtson, Susanne; Långström, Niklas

    2007-06-01

    Meta-analyses suggest that actuarial risk assessments outperform unguided clinical judgment for prediction of recidivism in criminal offenders. However, there is a lack of direct comparisons of the predictive accuracy of clinical judgment and actuarial risk scales for sexual offenders. We followed up 121 male sex offenders (> or =18 years) subjected to pre-trial forensic psychiatric assessment in Denmark in 1978-1992 (mean post-detainment time = 16.4 years) to compare the predictive validity of unstructured clinical judgment of recidivism risk with that of the well-established Static-99 (Hanson and Thornton, Law and Human Behavior 24:119-136, 2000) and an extension of the Static-99, the Static-2002 (Hanson and Thornton, Notes on the development of Static-2002 (Rep. No. 2003-01), Public Safety and Emergency Preparedness Canada, Ottawa, Canada, 2003). The predictive accuracy of unguided judgment did not exceed chance for any sexual, severe sexual or any violent (sexual or non-sexual) reconviction (AUCs of the ROC curve = 0.52, 95%CI = 0.41-0.63; 0.50, 95%CI = 0.34-0.67; and 0.57, 95%CI = 0.40-0.73, respectively). In contrast, all three outcomes were predicted significantly better than chance by the Static-99 (AUC = 0.62, 95%CI = 0.52-0.72; 0.72, 95%CI = 0.59-0.84; and 0.71, 95%CI = 0.56-0.86) and the Static-2002 (AUC = 0.67, 95%CI = 0.57-0.77; 0.69, 95%CI = 0.56-0.83; and 0.70, 95%CI = 0.55-0.86). Static-99 outperformed clinical judgment for sexual recidivision (chi(2) = 5.11, df = 1, p < .05). The Static-2002 was significantly more accurate for the prediction of any sexual recidivism as compared to unguided clinical judgment but its advantage fell just short of statistical significance for severe sexual recidivism (chi(2) = 3.56, df = 1, p = 0.06). When tested for recidivism within 2 years, none of the three prediction methods yielded results significantly better than chance for any outcome. This direct trial of the unguided clinical method argues against its

  11. Vomiting and Hyponatremia Are Risk Factors for Worse Clinical Outcomes Among Patients Hospitalized Due to Nonsurgical Abdominal Pain

    PubMed Central

    Goren, Idan; Israel, Ariel; Carmel-neiderman, Narin n.; Kliers, Iris; Gringauz, Irina; Dagan, Amir; Lavi, Bruno; Segal, Omer; Segal, Gad

    2016-01-01

    Abstract After initial evaluation in the Emergency Department (ED), many patients complaining of abdominal pain are classified as suffering from nonsurgical abdominal pain (NSAP). Clinical characteristics and risk factors for worse prognosis were not published elsewhere. Characterizing the clinical profile of patients hospitalized due to NSAP and identifying predictor variables for worse clinical outcomes. We made a retrospective cohort analysis of patients hospitalized due to NSAP compared to matched control patients (for age, gender, and Charlson comorbidity index) hospitalized due to other, nonsurgical reasons in a ratio of 1 to 10. We further performed in-group analysis of patients admitted due to NSAP in order to appreciate variables (clinical and laboratory parameters) potentially associated with worse clinical outcomes. Overall 23,584 patients were included, of which 2144 were admitted due to NSAP and 21,440 were matched controls. Patients admitted due to NSAP had overall better clinical outcomes: they had lower rates of in-hospital and 30-days mortality (2.8% vs 5.5% and 7.9% vs 10.4% respectively, P < 0.001 for both comparisons). They also had a significantly shorter length of hospital stay (3.9 vs 6.2 days, P < 0.001). Rates of re-hospitalization within 30-days were not significantly different between study groups. Among patients hospitalized due to NSAP, we found that vomiting or hyponatremia at presentation or during hospital stay were associated with worse clinical outcomes. Compared to patients hospitalized due to other, nonsurgical reasons, the overall prognosis of patients admitted due to NSAP is favorable. The combination of NSAP with vomiting and hyponatremia is associated with worse clinical outcomes. PMID:27057886

  12. Risk.

    PubMed

    Cole, Stephen R; Hudgens, Michael G; Brookhart, M Alan; Westreich, Daniel

    2015-02-15

    The epidemiologist primarily studies transitions between states of health and disease. The purpose of the present article is to define a foundational parameter for such studies, namely risk. We begin simply and build to the setting in which there is more than 1 event type (i.e., competing risks or competing events), as well as more than 1 treatment or exposure level of interest. In the presence of competing events, the risks are a set of counterfactual cumulative incidence functions for each treatment. These risks can be depicted visually and summarized numerically. We use an example from the study of human immunodeficiency virus to illustrate concepts. PMID:25660080

  13. Human exposure to airborne aldehydes in Chinese medicine clinics during moxibustion therapy and its impact on risks to health.

    PubMed

    Hsu, Yi-Chyun; Chao, How-Ran; Shih, Shun-I

    2015-01-01

    Many air toxicants, and especially aldehydes, are generated by moxibustion, which means burning Artemisia argyi. Our goal was to investigate indoor-air aldehyde emissions in Chinese medicine clinics (CMCs) during moxibustion to further evaluate the potential health risks, including cancer risk and non-cancer risk, to the medical staff and adult patients. First, the indoor-air-quality in 60 public sites, including 15 CMCs, was investigated. Four CMCs with frequent use of moxibustion were selected from the 15 CMCs to gather the indoor airborne aldehydes in the waiting and therapy rooms. The mean values of formaldehyde and acetaldehyde in the CMCs' indoor air were 654 and 4230 μg m(-3), respectively, in the therapy rooms, and 155 and 850 μg m(-3), respectively, in the waiting rooms. The average lifetime cancer risks (Rs) and non-cancer risks (hazard quotients: HQs) of airborne formaldehyde and acetaldehyde among the CMC medical staff exceeded the acceptable criteria (R < 1.00 × 10(-3) and HQ < 1.00) for occupational workers. The patients' Rs and HQs were also slightly higher than the critical values (R = 1.00 × 10(-6) and HQ = 1.00). Our results indicate that airborne aldehydes pose a significant threat to the health of medical staff, and slightly affected the patients' health, during moxibustion in the CMCs.

  14. Integrating risk minimization planning throughout the clinical development and commercialization lifecycle: an opinion on how drug development could be improved

    PubMed Central

    Morrato, Elaine H; Smith, Meredith Y

    2015-01-01

    Pharmaceutical risk minimization programs are now an established requirement in the regulatory landscape. However, pharmaceutical companies have been slow to recognize and embrace the significant potential these programs offer in terms of enhancing trust with health care professionals and patients, and for providing a mechanism for bringing products to the market that might not otherwise have been approved. Pitfalls of the current drug development process include risk minimization programs that are not data driven; missed opportunities to incorporate pragmatic methods and market-based insights, outmoded tools and data sources, lack of rapid evaluative learning to support timely adaption, lack of systematic approaches for patient engagement, and questions on staffing and organizational infrastructure. We propose better integration of risk minimization with clinical drug development and commercialization work streams throughout the product lifecycle. We articulate a vision and propose broad adoption of organizational models for incorporating risk minimization expertise into the drug development process. Three organizational models are discussed and compared: outsource/external vendor, embedded risk management specialist model, and Center of Excellence. PMID:25750537

  15. Clinical Characteristics and Risk Factors of Left Ventricular Thrombus after Acute Myocardial Infarction: A Matched Case-control Study

    PubMed Central

    Jiang, Yue-Xin; Jing, Lin-De; Jia, You-Hong

    2015-01-01

    Background: Left ventricular thrombus (LVT) is reported to be a common complication in acute myocardial infarction (AMI) patients. And it has the potential to cause systemic embolism. This retrospective study was to present the current situation of LVT in clinical practice, as well as to evaluate the clinical characteristics and the risk factors of LVT after AMI. Methods: LVT cases (n = 96) were identified from 13,732 AMI (non-ST elevation myocardial infarction was excluded) patients in Fuwai Hospital's electronic medical records system from January 2003 to January 2013. The controls (n = 192) were gender- and age-matched AMI patients without LVT during this period. A conditional logistic regression (fitted by the Cox model) was performed to identify the independent risk factors. Results: The incidence of LVT after AMI was 0.7%. Univariate analysis indicated that the anterior myocardial infarction (especially extensive anterior myocardial infarction), lower left ventricular ejection fraction (LVEF), LVEF ≤40%, severe regional wall motion abnormalities (RWMA), pericardial effusion, and left ventricular aneurysm were all related to LVT after AMI. The independent risk factors obtained from the conditional logistic regression analysis were lower LVEF (odds ratio (OR) = 0.891, 95% confidence interval (CI): 0.828–0.960), extensive anterior myocardial infarction (OR = 6.403, 95% CI: 1.769–23.169), severe RWMA (OR = 7.348, 95% CI: 1.323–40.819), and left ventricular aneurysm (OR = 6.955, 95% CI: 1.673–28.921). Conclusions: This study indicated that lower LVEF, extensive anterior myocardial infarction, severe RWMA, and left ventricular aneurysm were independent risk factors of LVT after AMI. It also suggested that further efforts are needed for the LVT diagnosis after AMI in clinical practice. PMID:26365955

  16. Antiphospholipid antibodies and sub-clinical atherosclerosis in the Coronary Artery Risk Development in Young Adults (CARDIA) cohort

    PubMed Central

    Majka, Darcy S.; Liu, Kiang; Pope, Richard M.; Karlson, Elizabeth W.; Vu, Thanh-Huyen T.; Teodorescu, Marius; Chang, Rowland W.

    2013-01-01

    Objective and design Antiphospholipid antibodies (APA) have been associated with clinical cardiovascular disease, but it remains unclear whether APA are associated with sub-clinical atherosclerosis. This study examined the relationship between APA and sub-clinical atherosclerosis, measured as coronary artery calcification (CAC), in participants from the prospective Coronary Artery Risk Development in Young Adults (CARDIA) Study. Subjects and method 2,203 black and white participants with sera available from the CARDIA year 7 examination and CAC measured by computed tomography at years 15 or 20 were selected. Results Anti-β2-glycoprotein I (anti-β2-GPI) immunoglobulin (Ig) M, IgG, and IgA were positive in 7.0, 1.4, and 1.8 % of participants, respectively; anti-cardiolipin (aCL) IgM and IgG were positive in 1.5 and 1.0 %, respectively. 9.5 % of participants had CAC score >0 at year 15. Anti-β2-GPI IgM, IgG, IgA, and aCL IgG positivity were associated with CAC >0 at year 15 after adjustment for traditional cardiovascular risk factors; [odds ratios (95 % confidence intervals) were 1.7 (1.0, 3.1), 6.4 (2.4, 16.8), 5.6 (2.3, 13.2), and 5.1 (1.4, 18.6), respectively]. Anti-β2-GPI IgG was associated with year 20 CAC >0, and anti-β2-GPI IgA and aCL IgG were marginally associated. Conclusions These findings indicate that APA positivity during young adulthood is a risk factor for subsequent sub-clinical atherosclerosis and might play a role in the pathogenesis of atherosclerosis. PMID:23959159

  17. clinical risk factors for osteoporosis in Ireland and the UK: a comparison of FRAX and QFractureScores.

    PubMed

    Cummins, N M; Poku, E K; Towler, M R; O'Driscoll, O M; Ralston, S H

    2011-08-01

    Recently two algorithms have become available to estimate the 10-year probability of fracture in patients suspected to have osteoporosis on the basis of clinical risk factors: the FRAX algorithm and QFractureScores algorithm (QFracture). The aim of this study was to compare the performance of these algorithms in a study of fracture patients and controls recruited from six centers in the United Kingdom and Ireland. A total of 246 postmenopausal women aged 50-85 years who had recently suffered a low-trauma fracture were enrolled and their characteristics were compared with 338 female controls who had never suffered a fracture. Femoral bone mineral density was measured by dual-energy X-ray absorptiometry, and fracture risk was calculated using the FRAX and QFracture algorithms. The FRAX algorithm yielded higher scores for fracture risk than the QFracture algorithm. Accordingly, the risk of major fracture in the overall study group was 9.5% for QFracture compared with 15.2% for FRAX. For hip fracture risk the values were 2.9% and 4.7%, respectively. The correlation between FRAX and QFracture was R = 0.803 for major fracture and R = 0.857 for hip fracture (P ≤ 0.0001). Both algorithms yielded high specificity but poor sensitivity for prediction of osteoporosis. We conclude that the FRAX and QFracture algorithms yield similar results in the estimation of fracture risk. Both of these tools could be of value in primary care to identify patients in the community at risk of osteoporosis and fragility fractures for further investigation and therapeutic intervention.

  18. Infectious Risk Assessment of Unsafe Handling Practices and Management of Clinical Solid Waste

    PubMed Central

    Hossain, Md. Sohrab; Rahman, Nik Norulaini Nik Ab; Balakrishnan, Venugopal; Puvanesuaran, Vignesh R.; Sarker, Md. Zaidul Islam; Kadir, Mohd Omar Ab

    2013-01-01

    The present study was undertaken to determine the bacterial agents present in various clinical solid wastes, general waste and clinical sharp waste. The waste was collected from different wards/units in a healthcare facility in Penang Island, Malaysia. The presence of bacterial agents in clinical and general waste was determined using the conventional bacteria identification methods. Several pathogenic bacteria including opportunistic bacterial agent such as Pseudomonas aeruginosa, Salmonella spp., Klebsiella pneumoniae, Serratia marcescens, Acinetobacter baumannii, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, Streptococcus pyogenes were detected in clinical solid wastes. The presence of specific pathogenic bacterial strains in clinical sharp waste was determined using 16s rDNA analysis. In this study, several nosocomial pathogenic bacteria strains of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Lysinibacillus sphaericus, Serratia marcescens, and Staphylococcus aureus were detected in clinical sharp waste. The present study suggests that waste generated from healthcare facilities should be sterilized at the point of generation in order to eliminate nosocomial infections from the general waste or either of the clinical wastes. PMID:23435587

  19. Infectious risk assessment of unsafe handling practices and management of clinical solid waste.

    PubMed

    Hossain, Md Sohrab; Rahman, Nik Norulaini Nik Ab; Balakrishnan, Venugopal; Puvanesuaran, Vignesh R; Sarker, Md Zaidul Islam; Kadir, Mohd Omar Ab

    2013-01-31

    The present study was undertaken to determine the bacterial agents present in various clinical solid wastes, general waste and clinical sharp waste. The waste was collected from different wards/units in a healthcare facility in Penang Island, Malaysia. The presence of bacterial agents in clinical and general waste was determined using the conventional bacteria identification methods. Several pathogenic bacteria including opportunistic bacterial agent such as Pseudomonas aeruginosa, Salmonella spp., Klebsiella pneumoniae, Serratia marcescens, Acinetobacter baumannii, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, Streptococcus pyogenes were detected in clinical solid wastes. The presence of specific pathogenic bacterial strains in clinical sharp waste was determined using 16s rDNA analysis. In this study, several nosocomial pathogenic bacteria strains of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Lysinibacillus sphaericus, Serratia marcescens, and Staphylococcus aureus were detected in clinical sharp waste. The present study suggests that waste generated from healthcare facilities should be sterilized at the point of generation in order to eliminate nosocomial infections from the general waste or either of the clinical wastes.

  20. Physiotherapists working in clinics have increased risk for new-onset spine disorders: a 12-year population-based study.

    PubMed

    Liao, Jen-Chieh; Ho, Chung-Han; Chiu, Haw-Yen; Wang, Yu-Lin; Kuo, Li-Chieh; Liu, Cheng; Wang, Jhi-Joung; Lim, Sher-Wei; Kuo, Jinn-Rung

    2016-08-01

    Health care professionals are known to have a high risk for work-related musculoskeletal disorders. However, the information on the risk of new-onset spine-related musculoskeletal disorders (SRMDs) in health care professionals is insufficient. This study aimed to investigate new-onset spine disorder associations among physical, occupational, and pharmacy health care professionals working in different workplaces.Taiwan's National Health Insurance Research Database for registered medical personnel claims from 2000 to 2011 was analyzed. An age- and sex-matched longitudinal cohort study of 7448 subjects (1682 physiotherapists, 1682 occupational therapists [OTs], and 3724 pharmacists) with or without new-onset spine disorders was conducted. The hazard ratios for the development of new-onset spine disorders were estimated among these 3 groups.The overall percentage of new-onset SRMD for physiotherapists is 32.12. The median time from obtaining a registered license to developing SRMD is 1.94 years. The log-rank test showed that physiotherapists have the least possibility of having a SRMD-free rate (P < 0.0001). The Cox model showed that physiotherapists have a higher risk of new-onset SRMD (hazard ratio: 1.65, 95% confidence interval: 1.48-1.84, P < 0.0001) compared with OTs and pharmacists. Physiotherapists working in clinics have a 2.40-fold increased risk of developing SRMD (95% confidence interval: 1.97-2.92, P < 0.0001) relative to OTs and pharmacists.This may be the first study regarding new-onset SRMD in physiotherapists based on a powerful nationwide population-based database. We conclude that working in clinics is a potential risk for new-onset SRMD in physiotherapists. Therefore, we suggest that physiotherapists should pay more attention to this issue to prevent the development of spine disorders.

  1. The Prevalence of Clinical and Electrocardiographic Risk Factors of Cardiovascular Death among On-Duty Professional Firefighters

    PubMed Central

    Al-Zaiti, Salah S.; Carey, Mary G.

    2014-01-01

    Background Firefighters have twice as many cardiovascular deaths as police officers and four times as many as emergency medical responders. The etiology for this high prevalence remains unknown. The electrocardiogram (ECG) is a widely used tool to screen populations at risk, but yet there are no available on-duty, high-resolution electrocardiographic (ECG) recordings. Objective We sought to evaluate the prevalence of clinical and ECG risk factors among on-duty professional firefighters during 12-lead ECG holter monitoring and exercise stress testing. Methods Firefighters were recruited from Surveying and Assessing Firefighters Fitness and ECG (SAFFE) study. This descriptive study recruited firefighters from 7 firehouses across Western New York area, who all completed on-duty, 24-hour Holter ECG monitoring and a standard exercise stress test. All analyses were completed by a reviewer blinded to all clinical data. Results 112 firefighters (age 44±8 years, mostly white males) completed the study. Even though all firefighters were in normal sinus rhythm, over half of them had at least one high risk ECG risk factor present, including abnormal sympathetic tone (elevated heart rate, 54%), abnormal repolarization (wide QRS-T angle, 25%), myocardial scaring (fragmented QRS, 24%), and myocardial ischemia (ST depression, 24%). In addition, most firefighters tolerated the treadmill exercise stress test well (metabolic equivalent tasks 11.8+2.5), however, almost one third had abnormal stress tests that require further evaluation to rule out subclinical coronary artery disease. Conclusion Among on-duty professional firefighters, high risk ECG markers of fatal cardiac events and abnormal stress test results that warrant further evaluation are prevalent. Annual physical checkups with routine 12-lead ECG can identify those who might benefit from preventive cardiovascular services. PMID:24874885

  2. The Matrix Metalloproteinase-7 Polymorphism Rs10895304 Is Associated With Increased Recurrence Risk in Patients With Clinically Localized Prostate Cancer

    SciTech Connect

    Jaboin, Jerry J.; Hwang, Misun; Lopater, Zachary; Chen Heidi; Ray, Geoffrey L.; Perez, Carmen; Cai Qiuyin; Wills, Marcia L.; Lu Bo

    2011-04-01

    Purpose: To evaluate whether selected high-risk matrix metalloproteinase-7 single nucleotide polymorphisms influence clinicopathologic outcomes in patients with early-stage prostate cancer. Methods and Materials: Two hundred twelve prostate cancer patients treated with radical prostatectomy were evaluated with a median follow-up of 9.8 years. Genotyping was performed using hybridization with custom-designed allele-specific probes. Three single nucleotide polymorphisms within the matrix metalloproteinase-7 gene were assessed with respect to age at diagnosis, margin status, extracapsular extension, lymph node involvement, recurrence-free survival, and overall survival in paraffin-embedded prostate tissue specimens from patients with early-stage prostate cancer who underwent radical prostatectomy. Results: Rs10895304 was the sole significant polymorphism. The A/G genotype of rs10895304 had a statistically significant association with recurrence-free survival in postprostatectomy patients (p = 0.0061, log-rank test). The frequency of the risk-reducing genotype (A/A) was 74%, whereas that of the risk-enhancing genotypes (A/G and G/G) were 20% and 6%, respectively. Multivariable Cox regression analyses detected a significant association between rs10895304 and recurrences after adjustment for known prognostic factors. The G allele of this polymorphism was associated with increased risk of prostate cancer recurrence (adjusted hazards ratio, 3.375; 95% confidence interval 1.567-7.269; p < 0.001). The other assayed polymorphisms were not significant, and no correlations were made to other clinical variables. Conclusions: The A/G genotype of rs10895304 is predictive of decreased recurrence-free survival in patients with clinically localized prostate cancer. Our data suggest that for this subset of patients, prostatectomy alone may not be adequate for local control. This is a novel and relevant marker that should be evaluated for improved risk stratification of patients who

  3. Physiotherapists working in clinics have increased risk for new-onset spine disorders: a 12-year population-based study.

    PubMed

    Liao, Jen-Chieh; Ho, Chung-Han; Chiu, Haw-Yen; Wang, Yu-Lin; Kuo, Li-Chieh; Liu, Cheng; Wang, Jhi-Joung; Lim, Sher-Wei; Kuo, Jinn-Rung

    2016-08-01

    Health care professionals are known to have a high risk for work-related musculoskeletal disorders. However, the information on the risk of new-onset spine-related musculoskeletal disorders (SRMDs) in health care professionals is insufficient. This study aimed to investigate new-onset spine disorder associations among physical, occupational, and pharmacy health care professionals working in different workplaces.Taiwan's National Health Insurance Research Database for registered medical personnel claims from 2000 to 2011 was analyzed. An age- and sex-matched longitudinal cohort study of 7448 subjects (1682 physiotherapists, 1682 occupational therapists [OTs], and 3724 pharmacists) with or without new-onset spine disorders was conducted. The hazard ratios for the development of new-onset spine disorders were estimated among these 3 groups.The overall percentage of new-onset SRMD for physiotherapists is 32.12. The median time from obtaining a registered license to developing SRMD is 1.94 years. The log-rank test showed that physiotherapists have the least possibility of having a SRMD-free rate (P < 0.0001). The Cox model showed that physiotherapists have a higher risk of new-onset SRMD (hazard ratio: 1.65, 95% confidence interval: 1.48-1.84, P < 0.0001) compared with OTs and pharmacists. Physiotherapists working in clinics have a 2.40-fold increased risk of developing SRMD (95% confidence interval: 1.97-2.92, P < 0.0001) relative to OTs and pharmacists.This may be the first study regarding new-onset SRMD in physiotherapists based on a powerful nationwide population-based database. We conclude that working in clinics is a potential risk for new-onset SRMD in physiotherapists. Therefore, we suggest that physiotherapists should pay more attention to this issue to prevent the development of spine disorders. PMID:27512853

  4. Barriers to suicide risk management in clinical practice: a national survey of oncology nurses.

    PubMed

    Valente, Sharon; Saunders, Judith M

    2004-09-01

    Standards of practice identify the nurse's pivotal role in risk detection, assessment, intervention, and management of suicidal patients, but scant research explores the barriers that hinder this role. This study describes the analysis of barriers to suicide risk management from a survey of a random sample of members of a national organization, the Oncology Nursing Society (n = 1200), who participated in a descriptive study exploring nurses' knowledge and attitudes about suicide. The 454 (37%) respondents included respondents from the United States, Canada, and Puerto Rico. Instruments included a demographic inventory, the Suicide Opinion Questionnaire (SOQ), a suicide attitude measure (SUIATT), and a vignette of a suicidal patient. Nurses knew an average of 4.8 out of 9 suicide risk factors and 49.4% miscalculated the risk of suicide. In contrast with their moderate to high ratings of suicide risk, they indicated minimal interventions. Barriers to management of suicidal patients included deficits in skill, knowledge, referrals, patient teaching, advocacy, or consultation as well as participants' and religious/other values, uncomfortable feelings, personal experiences, and the weight of professional responsibility. Strategies for intervention include: suicide prevention education, consultation, values clarification, ethical analysis, and conflict resolution and psychosocial support to reduce barriers. Nurses are not alone in their request for more education about suicide prevention; this study confirms earlier research of psychologists and psychiatrists who report they need more education in suicide risk management. PMID:15371147

  5. Assessing the risk of type 1 allergy to enzymes present in laundry and cleaning products: evidence from the clinical data.

    PubMed

    Sarlo, Katherine; Kirchner, Donald B; Troyano, Esperanza; Smith, Larry A; Carr, Gregory J; Rodriguez, Carlos

    2010-05-27

    Microbial enzymes have been used in laundry detergent products for several decades. These enzymes have also long been known to have the potential to give rise to occupational type 1 allergic responses. A few cases of allergy among consumers using dusty enzyme detergents were reported in the early 1970s. Encapsulation of the enzymes along with other formula changes were made to ensure that consumer exposure levels were sufficiently low that the likelihood of either the induction of IgE antibody (sensitization) or the elicitation of clinical symptoms be highly improbable. Understanding the consumer exposure to enzymes which are used in laundry and cleaning products is a key step to the risk management process. Validation of the risk assessment conclusions and the risk management process only comes with practical experience and evidence from the marketplace. In the present work, clinical data from a range of sources collected over the past 40 years have been analysed. These include data from peer reviewed literature and enzyme specific IgE antibody test results in detergent manufacturers' employees and from clinical study subjects. In total, enzyme specific IgE antibody data were available on 15,765 individuals. There were 37 individuals with IgE antibody. The majority of these cases were from the 1970s where 23 of 4687 subjects (0.49%) were IgE positive and 15 of the 23 were reported to have symptoms of allergy. The remaining 14 cases were identified post-1977 for a prevalence of 0.126% (14/11,078). No symptoms were reported and no relationship to exposure to laundry and cleaning products was found. There was a significant difference between the pre- and post-1977 cohorts in that the higher rates of sensitization with symptoms were associated with higher exposure to enzyme. The clinical testing revealed that the prevalence of enzyme specific IgE in the population is very rare (0.126% since 1977). This demonstrates that exposure to these strong respiratory allergens

  6. Clinical high-risk designation does not predict excess fetal-maternal hemorrhage.

    PubMed

    Ness, P M; Baldwin, M L; Niebyl, J R

    1987-01-01

    During a 5-year period, an enzyme-linked antiglobulin test was used to screen and quantitate fetal-maternal hemorrhage in 789 consecutive D-negative mothers who were delivered of D-positive babies. Six hundred seventy-two patients (85.2%) had no detectable fetal-maternal hemorrhage, and 117 patients (14.8%) had a detectable fetal-maternal hemorrhage. Eight of the 789 (1%) had a fetal-maternal hemorrhage greater than 30 ml and required more than one vial of Rh immune globulin. Two patients with fetal-maternal hemorrhage of 29 and 30 ml also received additional Rh immune globulin. Each case was reviewed for the presence of high-risk features that are thought to predict patients at risk for fetal-maternal hemorrhage. Patients having a cesarean section or complicated vaginal delivery were considered to be in a group at high risk for fetal-maternal hemorrhage, while those with a spontaneous vaginal delivery were considered not to be at risk for fetal-maternal hemorrhage. Thirty-two of 237 patients (13.5%) in the risk group and 82 of 552 patients (15.3%) in the group not at risk had detectable fetal-maternal hemorrhage. The incidence of fetal-maternal hemorrhage for these two groups was not statistically different (p greater than 0.50 by chi 2 analysis). If only patients in the risk group had been screened for fetal-maternal hemorrhage, then five of 10 (50%) who required more than one vial of Rh immune globulin would have been undertreated and at risk for developing anti-D antibodies. In addition, newborn birth weight, Apgar scores, and hematocrits were examined for 13 cases of fetal-maternal hemorrhage of greater than or equal to 21 ml, and none of these characteristics could be used to predict patients at risk for fetal-maternal hemorrhage. Therefore, no maternal or newborn characteristics could be identified that would reliably predict patients at risk for fetal-maternal hemorrhage. We conclude that all D-negative patients with D-positive babies should continue to be

  7. Risk, Reward, and the Double-Edged Sword: Perspectives on Pharmacogenetic Research and Clinical Testing Among Alaska Native People

    PubMed Central

    Robinson, Renee; Starks, Helene; Burke, Wylie; Dillard, Denise A.

    2013-01-01

    Objectives. Pharmacogenetic research and clinical testing raise important concerns for individuals and communities, especially where past medical research and practice has perpetrated harm and cultivated distrust of health care systems and clinicians. We investigated perceptions of pharmacogenetics among Alaska Native (AN) people. Methods. We held four focus groups for 32 ANs in south central Alaska to elicit views about pharmacogenetics in general and for treatment of cardiovascular disease, breast cancer, depression, and nicotine addiction. We analyzed data for perceived risks and rewards of pharmacogenetics. Results. Potential risks of pharmacogenetics included health care rationing, misuse of information, and stigma to individuals and the AN community. Potential rewards included decreased care costs, improved outcomes, and community development. Participants also discussed 8 contingent conditions that could mitigate risks and increase pharmacogenetic acceptability. Conclusions. Alaska Natives perceive pharmacogenetics as potentially benefitting and harming individuals, communities, and health systems, depending on methods and oversight. Researchers, clinicians, and administrators, especially in community-based clinic and health care systems serving minority populations, must address this “double-edged sword” to effectively conduct pharmacogenetics. PMID:24134351

  8. High-risk angina patient. Identification by clinical features, hospital course, electrocardiography and technetium-99m stannous pyrophosphate scintigraphy

    SciTech Connect

    Olson, H.G.; Lyons, K.P.; Aronow, W.S.; Stinson, P.J.; Kuperus, J.; Waters, H.J.

    1981-10-01

    We evaluated 193 consecutive unstable angina patients by clinical features, hospital course and electrocardiography. All patients were managed medically. Of the 193 patients, 150 (78%) had a technetium-99m pyrophosphate (Tc-PYP) myocardial scintigram after hospitalization. Of these, 49 (33%) had positive scintigrams. At a follow-up of 24.9 +/- 10.8 months after hospitalization, 16 of 49 patients (33%) with positive scintigrams died from cardiac causes, compared with six of 101 patients (6%) with negative scintigrams (p less than 0.001). Of 49 patients with positive scintigrams, 11 (22%) had had nonfatal myocardial infarction at follow-up, compared with seven of 101 patients (7%) with negative scintigrams (p less than 0.01). Age, duration of clinical coronary artery disease, continuing angina during hospitalization, ischemic ECG, cardiomegaly and a history of heart failure also correlated with cardiac death at follow-up. Ischemic ECG and a history of angina with a crescendo pattern also correlated with nonfatal infarction at follow-up. Patients with continuing angina, an ischemic ECG and a positive scintigram constituted a high-risk unstable angina subgroup with a survival rate of 58% at 6 months, 47% at 12 months and 42% at 24 and 36 months. We conclude that the assessment of clinical features, hospital course, ECG and Tc-PYP scintigraphy may be useful in identifying high-risk unstable angina patients.

  9. High-risk angina patient: identification by clinical features, hospital course, electrocardiography, and technetium-99m stannous pyrophosphate scintigraphy

    SciTech Connect

    Olson, H.G.; Lyons, K.P.; Aronow, W.S.; Stinson, P.J.; Kuperus, J.; Waters, H.J.

    1981-10-01

    We evaluated 193 consecutive unstable angina patients by clinical features, hospital course and electrocardiography. All patients were managed medically. Of the 193 patients, 150 (78%) had a technetium-99m pyrophosphate (Tc-PYP) myocardial scintigram after hospitalization. Of these, 49 (33%) had positive scintigrams. At a follow-up of 24.9 +- 10.8 months after hospitalization, 16 of 49 patients (33%) with positive scintigrams died from cardiac causes, compared with six of 101 patients (6%) with negative scintigrams (p < 0.001). Of 49 patients with positive scintigrams, 11 (22%) had had nonfatal myocardial infarction at follow-up, compared with seven of 101 patients (7%) with negative scintigrams (p < 0.01). Age, duration of clinical coronary artery disease, continuing angina during hospitalization, ischemic ECG, cardiomegaly and a history of heart failure also correlated with cardiac death at follow-up. Ischemic ECG and a history of angina with a crescendo pattern also correlated with nonfatal infarction at follow-up. Patients with continuing angina, an ischemic ECG and a positive scintigram constituted a high-risk unstable angina subgroup, with a survival rate of 58% at 6 months, 47% at 12 months and 42% at 24 and 36 months. We conclude that the assessment of clinical features, hospital course, ECG and Tc-PYP scintigraphy may be useful in identifying high-risk unstable angina patients.

  10. Genetic determinants of breast cancer risk: a review of current literature and issues pertaining to clinical application.

    PubMed

    Njiaju, Uchenna O; Olopade, Olufunmilayo I

    2012-09-01

    Despite major advances in breast cancer therapy, annual mortality remains significant with a sizeable proportion of patients eventually succumbing to metastatic disease. Clearly, optimizing approaches for identification and management of women at heightened risk for breast cancer will reduce overall morbidity and mortality from the disease. Over the past few decades, advances in molecular genetics and linkage analyses have allowed for the identification of specific germline mutations underlying a significant fraction of hereditary breast cancer. Genome-wide association studies have been developed as a powerful tool in identifying lower penetrance mutations, and it is believed that such genome-level variations may act in concert to give rise to the majority of inherited breast cancer risk. Controversies and uncertainties remain in clinical application of newly identified genomic loci that confer genetic susceptibility. This article reviews the well-characterized breast cancer susceptibility genes, highlights recent publications pertaining to the less well known and lower penetrance genetic polymorphisms, summarizes challenges in translating research findings to the clinical scenario, and offers some recommendations for clinical practice.

  11. Nutritional screening and risk factors in elderly hospitalized patients: association to clinical outcome?

    PubMed

    Holst, Mette; Yifter-Lindgren, Elinor; Surowiak, Mirek; Nielsen, Kari; Mowe, Morten; Carlsson, Maine; Jacobsen, Bent; Cederholm, Tommy; Fenger-Groen, Morten; Rasmussen, Henrik

    2013-12-01

    The aim of this study was to test the intervalidity of three different nutrition screening tools towards a broad population of elderly hospitalized patients. The association with risk factors and mortality was investigated. This is a prospective cohort study in three medical, surgical and geriatric settings, in Denmark and Sweden. Patients >65 years were consecutively included. Patients were screened by mini-nutritional assessment (MNA), malnutrition universal screening tool (MUST) and nutritional risk screening (NRS-2002). Anthropometrics, cognitive test (SPMSQ), as well as a questionnaire investigation regarding eating problems and life situation, were performed. Mortality within 12 months was investigated. In total, 233 patients mean (SD) age 81(7.64) years were included. A large variation in prevalence of nutritional risk was determined between the screening tools, MNA was 68% vs. MUST, 47% and NRS 54%, p < 0.0001. An overall agreement of 67% was seen (κ 0.52-0.55). Risk factors were associated with nutritional risk, including depressive mood. Only handgrip strength, fungus in mouth, serum albumin, CRP and cognitive function were associated with mortality. Fungus had the strongest association (OR 3.7; CI 1.19-11.30). The overall mortality rate was 27% during 12 months. However, none of the three screening tools predicted 12-month mortality. The findings show great variation in the prevalence of nutritional risk of under nutrition both between the tools and the settings. The level of agreement between the tools was moderate, and none of the three tools were capable of predicting 12-month mortality. A functional and psychological evaluation including oral health seems recommendable in elderly patients at nutritional risk.

  12. Risk

    NASA Technical Reports Server (NTRS)

    Barshi, Immanuel

    2016-01-01

    Speaking up, i.e. expressing ones concerns, is a critical piece of effective communication. Yet, we see many situations in which crew members have concerns and still remain silent. Why would that be the case? And how can we assess the risks of speaking up vs. the risks of keeping silent? And once we do make up our minds to speak up, how should we go about it? Our workshop aims to answer these questions, and to provide us all with practical tools for effective risk assessment and effective speaking-up strategies..

  13. Clinical relevance of 8q23, 15q13 and 18q21 SNP genotyping to evaluate colorectal cancer risk

    PubMed Central

    Baert-Desurmont, Stéphanie; Charbonnier, Françoise; Houivet, Estelle; Ippolito, Lorena; Mauillon, Jacques; Bougeard, Marion; Abadie, Caroline; Malka, David; Duffour, Jacqueline; Desseigne, Françoise; Colas, Chrystelle; Pujol, Pascal; Lejeune, Sophie; Dugast, Catherine; Buecher, Bruno; Faivre, Laurence; Leroux, Dominique; Gesta, Paul; Coupier, Isabelle; Guimbaud, Rosine; Berthet, Pascaline; Manouvrier, Sylvie; Cauchin, Estelle; Prieur, Fabienne; Laurent-Puig, Pierre; Lebrun, Marine; Jonveaux, Philippe; Chiesa, Jean; Caron, Olivier; Morin-Meschin, Marie-Emmanuelle; Polycarpe-Osaer, Florence; Giraud, Sophie; Zaanan, Aziz; Bonnet, Delphine; Mansuy, Ludovic; Bonadona, Valérie; El Chehadeh, Salima; Duhoux, François; Gauthier-Villars, Marion; Saurin, Jean-Christophe; Collonge-Rame, Marie- Agnès; Brugières, Laurence; Wang, Qing; Bressac-de Paillerets, Brigitte; Rey, Jean-Marc; Toulas, Christine; Buisine, Marie-Pierre; Bronner, Myriam; Sokolowska, Joanna; Hardouin, Agnès; Cailleux, Anne-Françoise; Sebaoui, Hakim; Blot, Julien; Tinat, Julie; Benichou, Jacques; Frebourg, Thierry

    2016-01-01

    To determine if the at-risk single-nucleotide polymorphism (SNP) alleles for colorectal cancer (CRC) could contribute to clinical situations suggestive of an increased genetic risk for CRC, we performed a prospective national case–control study based on highly selected patients (CRC in two first-degree relatives, one before 61 years of age; or CRC diagnosed before 51 years of age; or multiple primary CRCs, the first before 61 years of age; exclusion of Lynch syndrome and polyposes) and controls without personal or familial history of CRC. SNPs were genotyped using SNaPshot, and statistical analyses were performed using Pearson's χ2 test, Cochran–Armitage test of trend and logistic regression. We included 1029 patients and 350 controls. We confirmed the association of CRC risk with four SNPs, with odds ratio (OR) higher than previously reported: rs16892766 on 8q23.3 (OR: 1.88, 95% confidence interval (CI): 1.30–2.72; P=0.0007); rs4779584 on 15q13.3 (OR: 1.42, CI: 1.11–1.83; P=0.0061) and rs4939827 and rs58920878/Novel 1 on 18q21.1 (OR: 1.49, CI: 1.13–1.98; P=0.007 and OR: 1.49, CI: 1.14–1.95; P=0.0035). We found a significant (P<0.0001) cumulative effect of the at-risk alleles or genotypes with OR at 1.62 (CI: 1.10–2.37), 2.09 (CI: 1.43–3.07), 2.87 (CI: 1.76–4.70) and 3.88 (CI: 1.72–8.76) for 1, 2, 3 and at least 4 at-risk alleles, respectively, and OR at 1.71 (CI: 1.18–2.46), 2.29 (CI: 1.55–3.38) and 6.21 (CI: 2.67–14.42) for 1, 2 and 3 at-risk genotypes, respectively. Combination of SNPs may therefore explain a fraction of clinical situations suggestive of an increased risk for CRC. PMID:25873010

  14. Radiotherapy-Induced Malignancies: Review of Clinical Features, Pathobiology, and Evolving Approaches for Mitigating Risk

    PubMed Central

    Braunstein, Steve; Nakamura, Jean L.

    2013-01-01

    One of the most significant effects of radiation therapy on normal tissues is mutagenesis, which is the basis for radiation-induced malignancies. Radiation-induced malignancies are late complications arising after radiotherapy, increasing in frequency among survivors of both pediatric and adult cancers. Genetic backgrounds harboring germline mutations in tumor suppressor genes are recognized risk factors. Some success has been found with using genome wide association studies to identify germline polymorphisms associated with susceptibility. The insights generated by genetics, epidemiology, and the development of experimental models are defining potential strategies to offer to individuals at risk for radiation-induced malignancies. Concurrent technological efforts are developing novel radiotherapy delivery to reduce irradiation of normal tissues, and thereby, to mitigate the risk of radiation-induced malignancies. The goal of this review is to discuss epidemiologic, modeling, and radiotherapy delivery data, where these lines of research intersect and their potential impact on patient care. PMID:23565507

  15. Emotion recognition deficits as predictors of transition in individuals at clinical high risk for schizophrenia: a neurodevelopmental perspective

    PubMed Central

    Corcoran, C. M.; Keilp, J. G.; Kayser, J.; Klim, C.; Butler, P. D.; Bruder, G. E.; Gur, R. C.; Javitt, D. C.

    2016-01-01

    Background Schizophrenia is characterized by profound and disabling deficits in the ability to recognize emotion in facial expression and tone of voice. Although these deficits are well documented in established schizophrenia using recently validated tasks, their predictive utility in at-risk populations has not been formally evaluated. Method The Penn Emotion Recognition and Discrimination tasks, and recently developed measures of auditory emotion recognition, were administered to 49 clinical high-risk subjects prospectively followed for 2 years for schizophrenia outcome, and 31 healthy controls, and a developmental cohort of 43 individuals aged 7–26 years. Deficit in emotion recognition in at-risk subjects was compared with deficit in established schizophrenia, and with normal neurocognitive growth curves from childhood to early adulthood. Results Deficits in emotion recognition significantly distinguished at-risk patients who transitioned to schizophrenia. By contrast, more general neurocognitive measures, such as attention vigilance or processing speed, were non-predictive. The best classification model for schizophrenia onset included both face emotion processing and negative symptoms, with accuracy of 96%, and area under the receiver-operating characteristic curve of 0.99. In a parallel developmental study, emotion recognition abilities were found to reach maturity prior to traditional age of risk for schizophrenia, suggesting they may serve as objective markers of early developmental insult. Conclusions Profound deficits in emotion recognition exist in at-risk patients prior to schizophrenia onset. They may serve as an index of early developmental insult, and represent an effective target for early identification and remediation. Future studies investigating emotion recognition deficits at both mechanistic and predictive levels are strongly encouraged. PMID:26040537

  16. The clinical safety of disabled patients: proposal for a methodology for analysis of health care risks and specific measures for improvement.

    PubMed

    Perea-Pérez, Bernardo; Labajo-González, Elena; Bratos-Murillo, Manuel; Santiago-Sáez, Andrés; Albarrán-Juan, Elena; Villa-Vigil, Alfonso

    2013-03-01

    The clinical risks associated with health care have been a known factor since ancient times, and their prevention has constituted one of the foundations of health care. However, concern for the risks involved in health care treatments has risen very significantly in recent years, becoming a modern current of concern for clinical health care risks which is referred to by the name of "patient safety" in the scientific literature. Unfortunately, there are no studies on patient safety in dental practice or case studies of adverse events in this practice. In addition to the lack of studies on adverse events in regular dental practice, there are even fewer references to treatment for disabled patients. In this article, we provide a "proposal for analysis" of the clinical risks associated with treating disabled patients, which will make it possible to evaluate the health care risks associated with the treatment of patients who have a specific disability, at one determined moment and in one specific environment.

  17. Risk factors for hepatitis B virus infection in black female attendees of a sexually transmitted disease clinic.

    PubMed

    Baddour, L M; Bucak, V A; Somes, G; Hudson, R

    1988-01-01

    Although recent data have supported the role of heterosexual activity in the transmission of hepatitis B virus infection in women, studies generating these data have enrolled few black women. We therefore examined black female participants attending our local health department's sexually transmitted disease clinic for the treatment of presumed uncomplicated gonorrhea in serologic and risk-factor surveys of hepatitis B virus infection. Twenty-four (17.6%) of 136 subjects tested had evidence of prior hepatitis B infection. Serologic evidence of hepatitis B infection was significantly associated with three different barometers of sexual activity that included: (1) years of sexual activity (P less than 0.005); (2) history of sexually transmitted disease (P less than 0.02); and (3) number of lifetime heterosexual partners (P less than 0.001). These data provide further support that the quantity of sexual exposure seems to be an important risk factor for hepatitis B infection in heterosexually active females.

  18. [Clinical and pathophysiological features of Japanese patients with type 2 diabetes mellitus and their risk factors for diabetic complication].

    PubMed

    Sone, Hirohito

    2015-12-01

    The pathophysiological backgrounds as well as clinical phenotypes of Japanese or East Asian patients with type 2 diabetes are quite different from those in Western countries. According to results of East Asian large-scale studies such as the Japan Diabetes Complications Study (JDCS), which is a representative cohort of Japanese patients with type 2 diabetes, Japanese patients had a much lower body mass index and lower incidence of coronary heart disease compared with Caucasian diabetic patients. Other differences between Japanese and Caucasian patients with type 2 diabetes could be found in risk factors such as fruit intake on retinopathy and significance of triglycerides, or the effects of moderate alcohol drinking on cardiovascular disease. These results demonstrated a necessity of ethnic group-specific risk evaluations and care of type 2 diabetes and its complications.

  19. Risk factors for hepatitis B virus infection in black female attendees of a sexually transmitted disease clinic.

    PubMed

    Baddour, L M; Bucak, V A; Somes, G; Hudson, R

    1988-01-01

    Although recent data have supported the role of heterosexual activity in the transmission of hepatitis B virus infection in women, studies generating these data have enrolled few black women. We therefore examined black female participants attending our local health department's sexually transmitted disease clinic for the treatment of presumed uncomplicated gonorrhea in serologic and risk-factor surveys of hepatitis B virus infection. Twenty-four (17.6%) of 136 subjects tested had evidence of prior hepatitis B infection. Serologic evidence of hepatitis B infection was significantly associated with three different barometers of sexual activity that included: (1) years of sexual activity (P less than 0.005); (2) history of sexually transmitted disease (P less than 0.02); and (3) number of lifetime heterosexual partners (P less than 0.001). These data provide further support that the quantity of sexual exposure seems to be an important risk factor for hepatitis B infection in heterosexually active females. PMID:3227474

  20. Prevalence of and risk factors for hepatitis C virus infection among STD clinic clientele in Miami, Florida

    PubMed Central

    Weisbord, J; Trepka, M; Zhang, G; Smith, I; Brewer, T

    2003-01-01

    Objectives: Hepatitis C virus (HCV) is the most common chronic blood borne viral infection in the United States. We assessed the HCV prevalence, risk factors, and sensitivity of the Centers for Disease Control and Prevention's (CDC) routine screening criteria among clients of a large urban sexually transmitted disease (STD) clinic. Methods: Participants were recruited from a public STD clinic in Miami, Florida, and were interviewed regarding known and potential risk factors. The survey assessed CDC screening criteria, as well as other risk factors (for example, intranasal drug use, history of incarceration, exchanging sex for money, number of lifetime sex partners, and history of an STD). Testing was done by enzyme immunoassay (EIA) and confirmed by recombinant immunoblot assay (RIBA). Results: The prevalence of anti-HCV positivity was 4.7%. Four variables were significantly associated with being anti-HCV positive, independent of confounding factors. These included injection drug use (odds ratio (OR) = 31.6; 95% confidence intervals (CI) 11.0 to 90.5); history of incarceration (OR = 3.0; 95% CI 1.1 to 8.1); sexual contact with an HCV positive person (OR 12.7; 95% CI 2.5 to 64.7); and older age (OR 1.4; 95% CI 1.2, 1.6). The sensitivity of CDC's routine screening criteria was 69% and specificity was 91%. Conclusions: The prevalence of anti-HCV in this clinic was similar to that determined in studies of comparable populations. Having sexual contact with an HCV positive person and history of incarceration were independently associated with being anti-HCV positive. CDC's screening criteria identified approximately two thirds of the anti-HCV positive participants. PMID:12576631

  1. Antiphospholipid syndrome in northwest Italy (APS Piedmont Cohort): demographic features, risk factors, clinical and laboratory profile.

    PubMed

    Bertero, M T; Bazzan, M; Carignola, R; Montaruli, B; Silvestro, E; Sciascia, S; Vaccarino, A; Baldovino, S; Roccatello, D

    2012-06-01

    We report the experience from the Antiphospholipid Antibodies (aPL) Regional Consortium in northwest Italy, meant to support clinical research and foster collaboration among health professionals regarding the diagnosis and management of antiphospholipid syndrome (APS) patients. This cohort-study (APS Piedmont Cohort) was designed to register the clinical characteristics at inception and associated immunological manifestations at diagnosis (if any) of patients who strictly fulfilled the current criteria for APS, all recruited at the Piedmont and Valle d'Aosta regions. Clinical and laboratory data from 217 APS patients (171 with vascular events, 33 with pregnancy morbidity and 13 with both), from 16 centres within the geographical area were collected. Venous thrombosis was recorded in 45.6% of patients, arterial thrombosis in 35%, small-vessel thrombosis in 1.12% and mixed arterial and venous thrombosis in the remaining 19.4% of the cases. Pregnancy morbidity included 19 patients with unexplained fetal death beyond the 10th week of pregnancy, 17 with premature birth before the 34th week and 10 with three or more unexplained spontaneous abortions before the 10th week of gestation. This consortium represents an instrument by which to audit clinical practice, to provide counselling to local centres and to sustain future basic and clinical APS research.

  2. Effects of relaxation on depression levels in women with high-risk pregnancies: a randomised clinical trial 1

    PubMed Central

    de Araújo, Wanda Scherrer; Romero, Walckiria Garcia; Zandonade, Eliana; Amorim, Maria Helena Costa

    2016-01-01

    ABSTRACT Objective: to analyse the effects of relaxation as a nursing intervention on the depression levels of hospitalised women with high-risk pregnancies. Methods: a randomised clinical trial realised in a reference centre for high-risk pregnancies. The sample consisted of 50 women with high-risk pregnancies (25 in the control group and 25 in the intervention group). The Benson relaxation technique was applied to the intervention group for five days. Control variables were collected using a predesigned form, and the signs and symptoms of depression were evaluated using the Edinburgh Postnatal Depression Scale (EPDS). The Statistical Package for Social Sciences (SPSS), version 20.0, was used with a significance level of 5%. The Wilcoxon and paired t-tests were used to evaluate depression levels between two timepoints. Using categorical data, the McNemar test was used to analyse differences in depression severity before and after the intervention. Results: depression levels decreased in the intervention group five days after the relaxation technique was applied (4.5 ± 3, p<0.05) compared with the levels at the first timepoint (10.3±5.9). Conclusion: as a nursing intervention, relaxation was effective in decreasing the symptoms of depression in hospitalised women with high-risk pregnancies. PMID:27627126

  3. Efficacy of a pharmacist-led cardiovascular risk reduction clinic for diabetic patients with and without mental health conditions.

    PubMed

    Taveira, Tracey H; Pirraglia, Paul A; Cohen, Lisa B; Wu, Wen-Chih

    2008-01-01

    Coexisting mental health conditions (MHCs) attenuate treatment effects in diabetes. A retrospective analysis was performed of a pharmacist-led cardiovascular risk reduction clinic (CRRC) targeting hypertension, diabetes, hyperlipidemia, and tobacco use in patients with at least one CRRC visit between January 2001 and January 2002. The United Kingdom Prospective Diabetes Study (UKPDS) risk change (after/before CRRC) for those with and without MHCs was compared. Of the 297 with diabetes and complete UKPDS data, 40.7% had at least 1 MHC (22.3% had a severe MHC). Patients with MHCs had a similar number of CRRC visits (4.7+/-2.6 vs 4.4+/-2.6) but had a lower baseline UKPDS score (0.31+/-0.18 vs 0.40+/-0.20; P=.001) compared with non-MHC patients. The risk change after CRRC was similar for those with and without MHCs (0.10+/-0.13 vs 0.10+/-0.14; P=.82), but patients with MHCs had a longer CRRC enrollment (245+/-152 vs 205+/-161 days; P<.03). The efficacy of the CRRC model to reduce cardiovascular risk is not attenuated by a concomitant MHC.

  4. Efficacy of low tidal volume ventilation in patients with different clinical risk factors for acute lung injury and the acute respiratory distress syndrome.

    PubMed

    Eisner, M D; Thompson, T; Hudson, L D; Luce, J M; Hayden, D; Schoenfeld, D; Matthay, M A

    2001-07-15

    In patients with acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), a recent ARDS Network randomized controlled trial demonstrated that a low tidal volume (VT) mechanical ventilation strategy (6 ml/kg) reduced mortality by 22% compared with traditional mechanical ventilation (12 ml/kg). In this study, we examined the relative efficacy of low VT mechanical ventilation among 902 patients with different clinical risk factors for ALI/ARDS who participated in ARDS Network randomized controlled trials. The clinical risk factor for ALI/ARDS was associated with substantial variation in mortality. The risk of death (before discharge home with unassisted breathing) was highest in patients with sepsis (43%); intermediate in subjects with pneumonia (36%), aspiration (37%), and other risk factors (35%); and lowest in those with trauma (11%) (p < 0.0001). Despite these differences in mortality, there was no evidence that the efficacy of the low VT strategy varied by clinical risk factor (p = 0.76, for interaction between ventilator group and risk factor). There was also no evidence of differential efficacy of low VT ventilation in the other study outcomes: proportion of patients achieving unassisted breathing (p = 0.59), ventilator-free days (p = 0.58), or development of nonpulmonary organ failure (p = 0.44). Controlling for demographic and clinical covariates did not appreciably affect these results. After reclassifying the clinical risk factors as pulmonary versus nonpulmonary predisposing conditions and infection-related versus non-infection-related conditions, there was still no evidence that the efficacy of low VT ventilation differed among clinical risk factor subgroups. In conclusion, we found no evidence that the efficacy of the low VT ventilation strategy differed among clinical risk factor subgroups for ALI/ARDS.

  5. Clinical and Biologic Features Predictive of Survival After Relapse of Neuroblastoma: A Report From the International Neuroblastoma Risk Group Project

    PubMed Central

    London, Wendy B.; Castel, Victoria; Monclair, Tom; Ambros, Peter F.; Pearson, Andrew D.J.; Cohn, Susan L.; Berthold, Frank; Nakagawara, Akira; Ladenstein, Ruth L.; Iehara, Tomoko; Matthay, Katherine K.

    2011-01-01

    Purpose Survival after neuroblastoma relapse is poor. Understanding the relationship between clinical and biologic features and outcome after relapse may help in selection of optimal therapy. Our aim was to determine which factors were significantly predictive of postrelapse overall survival (OS) in patients with recurrent neuroblastoma—particularly whether time from diagnosis to first relapse (TTFR) was a significant predictor of OS. Patients and Methods Patients with first relapse/progression were identified in the International Neuroblastoma Risk Group (INRG) database. Time from study enrollment until first event and OS time starting from first event were calculated. Cox regression models were used to calculate the hazard ratio of increased death risk and perform survival tree regression. TTFR was tested in a multivariable Cox model with other factors. Results In the INRG database (N = 8,800), 2,266 patients experienced first progression/relapse. Median time to relapse was 13.2 months (range, 1 day to 11.4 years). Five-year OS from time of first event was 20% (SE, ± 1%). TTFR was statistically significantly associated with OS time in a nonlinear relationship; patients with TTFR of 36 months or longer had the lowest risk of death, followed by patients who relapsed in the period of 0 to less than 6 months or 18 to 36 months. Patients who relapsed between 6 and 18 months after diagnosis had the highest risk of death. TTFR, age, International Neuroblastoma Staging System stage, and MYCN copy number status were independently predictive of postrelapse OS in multivariable analysis. Conclusion Age, stage, MYCN status, and TTFR are significant prognostic factors for postrelapse survival and may help in the design of clinical trials evaluating novel agents. PMID:21768459

  6. Prevalence and predictors of Lymphogranuloma venereum in a high risk population attending a STD outpatients clinic in Italy

    PubMed Central

    2014-01-01

    Background We evaluated LGV prevalence and predictors in a high risk population attending a STI Outpatients Clinic in the North of Italy. Methods A total of 108 patients (99 MSM and 9 women), with a history of unsafe anal sexual intercourses, were enrolled. Anorectal swabs and urine samples were tested for Chlamydia trachomatis (CT) DNA detection by Versant CT/GC DNA 1.0 Assay (Siemens Healthcare Diagnostics Terrytown, USA). RFLP analysis was used for CT molecular typing. Results L2 CT genotype was identified in 13/108 (12%) rectal swabs. All LGV cases were from MSM, declaring high-risk sexual behaviour and complaining anorectal symptoms. Patients first attending the STI Outpatient Clinic received a significant earlier LGV diagnosis than those first seeking care from general practitioners or gastroenterologists (P = 0.0046). LGV prevalence and characteristics found in our population are in agreement with international reports. Statistical analysis showed that LGV positive patients were older (P = 0.0008) and presented more STIs (P = 0.0023) than LGV negative ones, in particular due to syphilis (P < 0.001), HIV (P < 0.001) and HBV (P = 0.001). Multivariate logistic regression analysis revealed that HIV and syphilis infections are strong risk factors for LGV presence (respectively, P = 0.001 and P = 0.010). Conclusions Even if our results do not provide sufficient evidence to recommend routine screening of anorectal swabs in high-risk population, they strongly suggest to perform CT NAAT tests and genotyping on rectal specimens in presence of ulcerative proctitis in HIV and/or syphilis-positive MSM. In this context, CT DNA detection by Versant CT/GC DNA 1.0 Assay, followed by RFLP analysis for molecular typing demonstrated to be an excellent diagnostic algorithm for LGV identification. PMID:24716676

  7. Clinical decisions in patients with diabetes and other cardiovascular risk factors. A statement of the Spanish Society of Internal Medicine.

    PubMed

    Gómez-Huelgas, R; Pérez-Jiménez, F; Serrano-Ríos, M; González-Santos, P; Román, P; Camafort, M; Conthe, P; García-Alegría, J; Guijarro, R; López-Miranda, J; Tirado-Miranda, R; Valdivielso, P

    2014-05-01

    Although the mortality associated to cardiovascular diseases (CVD) has been reduced in the last decades, CVD remains the main cause of mortality in Spain and they are associated with an important morbidity and a huge economic burden. The increasing prevalence of obesity and diabetes could be slowing down the mortality reduction in Spain. Clinicians have often difficulty making clinical decisions due to the multiple clinical guidelines available. Moreover, in the current context of economic crisis it is critical to promote an efficient use of diagnostic and therapeutic proceedings to ensure the viability of public health care systems. The Spanish Society of Internal Medicine (SEMI) has coordinated a consensus document to answer questions of daily practice with the aim of facilitating physicians' decision-making in the management of diabetes and cardiovascular risk factors from a cost-efficiency point of view.

  8. Clinical decisions in patients with diabetes and other cardiovascular risk factors. A statement of the Spanish Society of Internal Medicine.

    PubMed

    Gómez-Huelgas, R; Pérez-Jiménez, F; Serrano-Ríos, M; González-Santos, P; Román, P; Camafort, M; Conthe, P; García-Alegría, J; Guijarro, R; López-Miranda, J; Tirado-Miranda, R; Valdivielso, P

    2014-05-01

    Although the mortality associated to cardiovascular diseases (CVD) has been reduced in the last decades, CVD remains the main cause of mortality in Spain and they are associated with an important morbidity and a huge economic burden. The increasing prevalence of obesity and diabetes could be slowing down the mortality reduction in Spain. Clinicians have often difficulty making clinical decisions due to the multiple clinical guidelines available. Moreover, in the current context of economic crisis it is critical to promote an efficient use of diagnostic and therapeutic proceedings to ensure the viability of public health care systems. The Spanish Society of Internal Medicine (SEMI) has coordinated a consensus document to answer questions of daily practice with the aim of facilitating physicians' decision-making in the management of diabetes and cardiovascular risk factors from a cost-efficiency point of view. PMID:24602600

  9. Communicating clinical research to reduce cancer risk through diet: Walnuts as a case example

    PubMed Central

    2014-01-01

    Inflammation is one mechanism through which cancer is initiated and progresses, and is implicated in the etiology of other conditions that affect cancer risk and prognosis, such as type 2 diabetes, cardiovascular disease, and visceral obesity. Emerging human evidence, primarily epidemiological, suggests that walnuts impact risk of these chronic diseases via inflammation. The published literature documents associations between walnut consumption and reduced risk of cancer, and mortality from cancer, diabetes, and cardiovascular disease, particularly within the context of the Mediterranean Diet. While encouraging, follow-up in human intervention trials is needed to better elucidate any potential cancer prevention effect of walnuts, per se. In humans, the far-reaching positive effects of a plant-based diet that includes walnuts may be the most critical message for the public. Indeed, appropriate translation of nutrition research is essential for facilitating healthful consumer dietary behavior. This paper will explore the translation and application of human evidence regarding connections with cancer and biomarkers of inflammation to the development of dietary guidance for the public and individualized dietary advice. Strategies for encouraging dietary patterns that may reduce cancer risk will be explored. PMID:25110552

  10. Associating changes in the immune system with clinical diseases for interpretation in risk assessment.

    PubMed

    Luster, Michael I; Germolec, Dori R; Parks, Christine G; Blaciforti, Laura; Kashon, Michael; Luebke, Robert

    2004-01-01

    This overview unit discusses the relationship between immunosuppression, a potential consequence of immunotoxicity, and disease progression. It also discusses other factors, such as stress and age, that affect disease susceptibility. These factors play an important role in risk assessment for exposures to environmental factors.

  11. Associating Changes in the Immune System with Clinical Diseases for Interpretation in Risk Assessment##

    EPA Science Inventory

    This overview is a revision to the unit originally published in 2004. While the basic tenants of immunotoxicity have not changed in the past 10 years, several publications have explored the application of immunotoxicological data to the risk assessment process. Therefore, the goa...

  12. Multiple sclerosis, brain radiotherapy, and risk of neurotoxicity: The Mayo Clinic experience

    SciTech Connect

    Miller, Robert C. . E-mail: miller.robert@mayo.edu; Lachance, Daniel H.; Lucchinetti, Claudia F.; Keegan, B. Mark; Gavrilova, Ralitza H.; Brown, Paul D.; Weinshenker, Brian G.; Rodriguez, Moses

    2006-11-15

    Purpose: The aim of this study was a retrospective assessment of neurotoxicity in patients with multiple sclerosis (MS) receiving external beam radiotherapy (EBRT) to the brain. Methods and Materials: We studied 15 consecutively treated patients with MS who received brain EBRT. Neurologic toxicity was assessed with the Common Toxicity Criteria v.3.0. Results: Median follow-up for the 5 living patients was 6.0 years (range, 3.3-27.4 years). No exacerbation of MS occurred in any patient during EBRT. Five patients had Grade 4 neurologic toxicity and 1 had possible Grade 5 toxicity. Kaplan-Meier estimated risk of neurotoxicity greater than Grade 4 at 5 years was 57% (95% confidence interval, 27%-82%). Toxicity occurred at 37.5 to 54.0 Gy at a median of 1.0 year (range, 0.2-4.3 years) after EBRT. Univariate analysis showed an association between opposed-field irradiation of the temporal lobes, central white matter, and brainstem and increased risk of neurotoxicity (p < 0.04). Three of 6 cases of toxicity occurred in patients treated before 1986. Conclusions: External beam radiotherapy of the brain in patients with MS may be associated with an increased risk of neurotoxicity compared with patients without demyelinating illnesses. However, this risk is associated with treatment techniques that may not be comparable to modern, conformal radiotherapy.

  13. Health Risk Behaviors in Spina Bifida: The Need for Clinical and Policy Action

    ERIC Educational Resources Information Center

    Sawin, Kathleen J.; Brei, Timothy J.

    2012-01-01

    Health risk behaviors (HRBs) in adults with spina bifida such as poor diet, reduced physical activity, increased television viewing time, and substance abuse often have their genesis in early childhood. They are potentially preventable but if not addressed aggressively may continue to progress across the lifespan. Findings from a population-based…

  14. Prevalence and Risk Factors of Obesity among Elderly Attending Geriatric Outpatient Clinics in Mansoura City

    ERIC Educational Resources Information Center

    Shebl, Amany Mohamed; Hatata, El Sayed Zaki; Boughdady, Aziza Mahmoud; El-Sayed, Sally Mohammed

    2015-01-01

    Obesity is a major public health problem affecting all ages in both developed and developing countries. It is considered the fifth leading risk factor for deaths all over the world as about 2.8 million people die due to obesity each year directly or indirectly. Obesity in elderly is considered one of the most serious public health challenges for…

  15. Asian dust storm elevates children's respiratory health risks: a spatiotemporal analysis of children's clinic visits across Taipei (Taiwan).

    PubMed

    Yu, Hwa-Lung; Chien, Lung-Chang; Yang, Chiang-Hsing

    2012-01-01

    Concerns have been raised about the adverse impact of Asian dust storms (ADS) on human health; however, few studies have examined the effect of these events on children's health. Using databases from the Taiwan National Health Insurance and Taiwan Environmental Protection Agency, this study investigates the documented daily visits of children to respiratory clinics during and after ADS that occurred from 1997 to 2007 among 12 districts across Taipei City by applying a Bayesian structural additive regressive model controlled for spatial and temporal patterns. This study finds that the significantly impact of elevated children's respiratory clinic visits happened after ADS. Five of the seven lagged days had increasing percentages of relative rate, which was consecutively elevated from a 2-day to a 5-day lag by 0.63%∼2.19% for preschool children (i.e., 0∼6 years of age) and 0.72%∼3.17% for school children (i.e., 7∼14 years of age). The spatial pattern of clinic visits indicated that geographical heterogeneity was possibly associated with the clinic's location and accessibility. Moreover, day-of-week effects were elevated on Monday, Friday, and Saturday. We concluded that ADS may significantly increase the risks of respiratory diseases consecutively in the week after exposure, especially in school children. PMID:22848461

  16. Asian dust storm elevates children's respiratory health risks: a spatiotemporal analysis of children's clinic visits across Taipei (Taiwan).

    PubMed

    Yu, Hwa-Lung; Chien, Lung-Chang; Yang, Chiang-Hsing

    2012-01-01

    Concerns have been raised about the adverse impact of Asian dust storms (ADS) on human health; however, few studies have examined the effect of these events on children's health. Using databases from the Taiwan National Health Insurance and Taiwan Environmental Protection Agency, this study investigates the documented daily visits of children to respiratory clinics during and after ADS that occurred from 1997 to 2007 among 12 districts across Taipei City by applying a Bayesian structural additive regressive model controlled for spatial and temporal patterns. This study finds that the significantly impact of elevated children's respiratory clinic visits happened after ADS. Five of the seven lagged days had increasing percentages of relative rate, which was consecutively elevated from a 2-day to a 5-day lag by 0.63%∼2.19% for preschool children (i.e., 0∼6 years of age) and 0.72%∼3.17% for school children (i.e., 7∼14 years of age). The spatial pattern of clinic visits indicated that geographical heterogeneity was possibly associated with the clinic's location and accessibility. Moreover, day-of-week effects were elevated on Monday, Friday, and Saturday. We concluded that ADS may significantly increase the risks of respiratory diseases consecutively in the week after exposure, especially in school children.

  17. Risk prediction and clinical model building for lymph node metastasis in papillary thyroid microcarcinoma

    PubMed Central

    Lin, Dao-zhe; Qu, Ning; Shi, Rong-liang; Lu, Zhong-wu; Ji, Qing-hai; Wu, Wei-li

    2016-01-01

    The surgical management of papillary thyroid microcarcinoma (PTMC), especially regarding the necessity of central/lateral lymph node dissection, remains controversial. This study investigated the clinicopathologic factors predictive of lymph node metastasis (LNM) in patients diagnosed with PTMC. Multivariate logistic regression analysis was used for PTMC patients identified from the Surveillance, Epidemiology, and End Results database who were treated by surgery between 2002 and 2012, to determine the association of clinicopathologic factors with LNM. According to the results, a total of 31,017 patients met the inclusion criteria of the study. Final histology confirmed 2,135 (6.9%) cases of N1a disease and 1,684 cases (5.4%) of N1b disease. Our multivariate logistic regression analysis identified variables associated with both central LNM and lateral lymph node metastasis (LLNM), including a younger age (<45 years), male sex, non-Hispanic white and other race, classical papillary histology, larger tumor size, multifocality, and extrathyroidal extension; distant metastasis was also significantly associated with LLNM. The significant predictors identified from multivariable logistic regression were integrated into a statistical model that showed that extrathyroidal extension had maximum weight in the predictive role for LNM. LLNM was validated to be a significant risk factor for cancer-specific death in Cox regression analyses, whereas central LNM failed to predict a worse cancer-specific survival according to our data. Therefore, we suggested that central lymph node dissection could be performed in certain patients with risk factors. Given the prevalence of LLNM in PTMC, a thorough inspection of the lateral compartment is recommended in PTMC patients with risk factors for precise staging; from the viewpoint of a radical treatment for tumors, prophylactic lateral lymph node dissection that aims to remove the occult lateral lymph nodes may be an option for PTMC with

  18. Women at high risk of breast cancer: Molecular characteristics, clinical presentation and management.

    PubMed

    Kleibl, Zdenek; Kristensen, Vessela N

    2016-08-01

    The presence of breast cancer in any first-degree female relative in general nearly doubles the risk for a proband and the risk gradually increases with the number of affected relatives. Current advances in molecular oncology and oncogenetics may enable the identification of high-risk individuals with breast-cancer predisposition. The best-known forms of hereditary breast cancer (HBC) are caused by mutations in the high-penetrance genes BRCA1 and BRCA2. Other genes, including PTEN, TP53, STK11/LKB1, CDH1, PALB2, CHEK2, ATM, MRE11, RAD50, NBS1, BRIP1, FANCA, FANCC, FANCM, RAD51, RAD51B, RAD51C, RAD51D, and XRCC2 have been described as high- or moderate-penetrance breast cancer-susceptibility genes. The majority of breast cancer-susceptibility genes code for tumor suppressor proteins that are involved in critical processes of DNA repair pathways. This is of particular importance for those women who, due to their increased risk of breast cancer, may be subjected to more frequent screening but due to their repair deficiency might be at the risk of developing radiation-induced malignancies. It has been proven that cancers arising from the most frequent BRCA1 gene mutation carriers differ significantly from the sporadic disease of age-matched controls in their histopathological appearances and molecular characteristics. The increased depth of mutation detection brought by next-generation sequencing and a better understanding of the mechanisms through which these mutations cause the disease will bring novel insights in terms of oncological prevention, diagnostics, and therapeutic options for HBC patients.

  19. Risk prediction and clinical model building for lymph node metastasis in papillary thyroid microcarcinoma.

    PubMed

    Lin, Dao-Zhe; Qu, Ning; Shi, Rong-Liang; Lu, Zhong-Wu; Ji, Qing-Hai; Wu, Wei-Li

    2016-01-01

    The surgical management of papillary thyroid microcarcinoma (PTMC), especially regarding the necessity of central/lateral lymph node dissection, remains controversial. This study investigated the clinicopathologic factors predictive of lymph node metastasis (LNM) in patients diagnosed with PTMC. Multivariate logistic regression analysis was used for PTMC patients identified from the Surveillance, Epidemiology, and End Results database who were treated by surgery between 2002 and 2012, to determine the association of clinicopathologic factors with LNM. According to the results, a total of 31,017 patients met the inclusion criteria of the study. Final histology confirmed 2,135 (6.9%) cases of N1a disease and 1,684 cases (5.4%) of N1b disease. Our multivariate logistic regression analysis identified variables associated with both central LNM and lateral lymph node metastasis (LLNM), including a younger age (<45 years), male sex, non-Hispanic white and other race, classical papillary histology, larger tumor size, multifocality, and extrathyroidal extension; distant metastasis was also significantly associated with LLNM. The significant predictors identified from multivariable logistic regression were integrated into a statistical model that showed that extrathyroidal extension had maximum weight in the predictive role for LNM. LLNM was validated to be a significant risk factor for cancer-specific death in Cox regression analyses, whereas central LNM failed to predict a worse cancer-specific survival according to our data. Therefore, we suggested that central lymph node dissection could be performed in certain patients with risk factors. Given the prevalence of LLNM in PTMC, a thorough inspection of the lateral compartment is recommended in PTMC patients with risk factors for precise staging; from the viewpoint of a radical treatment for tumors, prophylactic lateral lymph node dissection that aims to remove the occult lateral lymph nodes may be an option for PTMC with

  20. Risk prediction and clinical model building for lymph node metastasis in papillary thyroid microcarcinoma

    PubMed Central

    Lin, Dao-zhe; Qu, Ning; Shi, Rong-liang; Lu, Zhong-wu; Ji, Qing-hai; Wu, Wei-li

    2016-01-01

    The surgical management of papillary thyroid microcarcinoma (PTMC), especially regarding the necessity of central/lateral lymph node dissection, remains controversial. This study investigated the clinicopathologic factors predictive of lymph node metastasis (LNM) in patients diagnosed with PTMC. Multivariate logistic regression analysis was used for PTMC patients identified from the Surveillance, Epidemiology, and End Results database who were treated by surgery between 2002 and 2012, to determine the association of clinicopathologic factors with LNM. According to the results, a total of 31,017 patients met the inclusion criteria of the study. Final histology confirmed 2,135 (6.9%) cases of N1a disease and 1,684 cases (5.4%) of N1b disease. Our multivariate logistic regression analysis identified variables associated with both central LNM and lateral lymph node metastasis (LLNM), including a younger age (<45 years), male sex, non-Hispanic white and other race, classical papillary histology, larger tumor size, multifocality, and extrathyroidal extension; distant metastasis was also significantly associated with LLNM. The significant predictors identified from multivariable logistic regression were integrated into a statistical model that showed that extrathyroidal extension had maximum weight in the predictive role for LNM. LLNM was validated to be a significant risk factor for cancer-specific death in Cox regression analyses, whereas central LNM failed to predict a worse cancer-specific survival according to our data. Therefore, we suggested that central lymph node dissection could be performed in certain patients with risk factors. Given the prevalence of LLNM in PTMC, a thorough inspection of the lateral compartment is recommended in PTMC patients with risk factors for precise staging; from the viewpoint of a radical treatment for tumors, prophylactic lateral lymph node dissection that aims to remove the occult lateral lymph nodes may be an option for PTMC with

  1. Women at high risk of breast cancer: Molecular characteristics, clinical presentation and management.

    PubMed

    Kleibl, Zdenek; Kristensen, Vessela N

    2016-08-01

    The presence of breast cancer in any first-degree female relative in general nearly doubles the risk for a proband and the risk gradually increases with the number of affected relatives. Current advances in molecular oncology and oncogenetics may enable the identification of high-risk individuals with breast-cancer predisposition. The best-known forms of hereditary breast cancer (HBC) are caused by mutations in the high-penetrance genes BRCA1 and BRCA2. Other genes, including PTEN, TP53, STK11/LKB1, CDH1, PALB2, CHEK2, ATM, MRE11, RAD50, NBS1, BRIP1, FANCA, FANCC, FANCM, RAD51, RAD51B, RAD51C, RAD51D, and XRCC2 have been described as high- or moderate-penetrance breast cancer-susceptibility genes. The majority of breast cancer-susceptibility genes code for tumor suppressor proteins that are involved in critical processes of DNA repair pathways. This is of particular importance for those women who, due to their increased risk of breast cancer, may be subjected to more frequent screening but due to their repair deficiency might be at the risk of developing radiation-induced malignancies. It has been proven that cancers arising from the most frequent BRCA1 gene mutation carriers differ significantly from the sporadic disease of age-matched controls in their histopathological appearances and molecular characteristics. The increased depth of mutation detection brought by next-generation sequencing and a better understanding of the mechanisms through which these mutations cause the disease will bring novel insights in terms of oncological prevention, diagnostics, and therapeutic options for HBC patients. PMID:27318168

  2. Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease

    PubMed Central

    Huang, Hsuan-Li; Juang, Jyh-Ming Jimmy; Chou, Hsin-Hua; Tsao, Chueh-Yung; Wu, Tien-Yu; Ko, Yu-Lin

    2015-01-01

    Background Clinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently. Methods This retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up. Results Most of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50–782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis. Conclusions Despite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment. PMID:26599128

  3. Clinical decision rule for primary care patient with acute low back pain at risk of developing chronic pain

    PubMed Central

    Mehling, Wolf E.; Ebell, Mark H.; Avins, Andrew L.; Hecht, Frederick M.

    2015-01-01

    Background Context Primary care clinicians need to identify candidates for early interventions to prevent patients with acute pain from developing chronic pain. Purpose We conducted a 2-year prospective cohort study of risk factors for the progression to chronic pain and developed and internally validated a clinical decision rule (CDR) that stratifies patients into low, medium and high-risk groups for chronic pain. Study Design/Setting Prospective cohort study in primary care. Patient Sample Patients with acute low back pain (LBP; ≤30 days duration) Outcome measures Self-reported perceived non-recovery and chronic pain. Methods Patients were surveyed at baseline, 6 months and 2 years. We conducted bivariate and multivariate regression analyses of demographic, clinical and psychosocial variables for chronic pain outcomes, developed a CDR and assessed its performance by calculating the bootstrapped areas under the receiver operating characteristic curve (AUC) and likelihood ratios. This study was supported by NIH/NCCAM grants K23 AT002298, R21 AT004467, NIH/NCCAM K24 AT007827, the Research Evaluation and Allocation Committee (REAC) of the University of California San Francisco, and the Mount Zion Health Fund, San Francisco. The funding agencies played no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. The authors report no conflict of interests. Results 605 patients enrolled. 13% had chronic pain at 6 months, 19% at 2 years. An eight-item CDR was most parsimonious for classifying patients into three risk levels. Bootstrapped AUC was 0.76 (0.70–0.82) for the 6-month CDR. Each 10-point score increase (60-point range) was associated with an odds ratio of 11.1 (10.8–11.4) for developing chronic pain. Using a <5% probability of chronic pain as the cutoff for low risk and a >40% probability for high risk, likelihood ratios were 0.26 (0.14–0.48) and 4

  4. Cardiovascular Risk of Stimulant Treatment in Pediatric Attention-Deficit/Hyperactivity Disorder: Update and Clinical Recommendations

    ERIC Educational Resources Information Center

    Hammerness, Paul G.; Perrin, James M.; Shelley-Abrahamson, Rachel; Wilens, Timothy E.

    2011-01-01

    Objective: This review provides an update on the cardiovascular impact of therapeutic stimulant-class medication for children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Method: Relevant clinical literature was ascertained using PubMed searches limited to human studies and the English language as of May 2011. Current…

  5. Initial Results of a New Clinical Practice Model: Impact on Learners at Risk

    ERIC Educational Resources Information Center

    Wasburn-Moses, Leah; Noltemeyer, Amity L.; Schmitz, Kristin J.

    2015-01-01

    The last several years have seen a dramatic increase in interest surrounding the role of clinical experiences in enhancing the learning of teacher candidates. Further, pressure has intensified to demonstrate the impact of teacher candidates on P-12 learners. With these goals in mind, a model alternative school/university partnership was created,…

  6. Risk factors for subclinical and clinical ketosis and association with production parameters in dairy cows in the Netherlands.

    PubMed

    Vanholder, T; Papen, J; Bemers, R; Vertenten, G; Berge, A C B

    2015-02-01

    Ketosis is associated with many transition cow diseases and the subclinical form has been found to be a common condition in high-producing dairy cows. The objectives of this field study in the Netherlands were (1) to determine risk factors for subclinical ketosis [SCK; 1.2-2.9mmol of β-hydroxybutyrate (BHBA)/L of serum] and clinical ketosis (CK: ≥3.0mmol of BHBA/L of serum) at 7 to 14 d in milk and (2) to assess the association of SCK and CK with production parameters at the first dairy herd improvement (DHI) testing. Twenty-three dairies were enrolled by a local veterinary practice from 2009 to 2010, and 1,715 cows were screened for ketosis by measuring serum BHBA concentrations at 7 to 14 d in milk. Overall, 47.2% of cows had SCK and 11.6% had CK. Mixed generalized logit models with a random effect of herd were used to evaluate cow level factors associated with SCK and CK. The associations of SCK and CK with milk production parameters were tested using mixed linear models with a random effect of herd. Cows at a moderate (3.25-3.75) or fat (≥4) body condition score before calving were more likely to develop SCK and CK than thin (body condition score≤3.0) cows. The risk for developing SCK was higher in parity 2 and older cows compared with heifers, whereas for CK only, parity ≥3 cows had a higher risk. The quarter of the year in which a cow calved was associated with the risk for SCK and CK. For SCK quarter 1 (January-March) and quarter 2 (April-June), and for CK quarter 1, quarter 2, and quarter 3 (July-September) all increased the risk of development of the condition compared with quarter 4 (October-December). An increased yield of colostrum at first milking was associated with increasing risk for SCK and CK. Prolonged previous lactation length and dry period length were both associated with increased odds for SCK and CK. Subclinical ketosis and CK were associated with a higher milk yield, a higher milk fat percentage, and a lower milk protein percentage

  7. Risk factors for subclinical and clinical ketosis and association with production parameters in dairy cows in the Netherlands.

    PubMed

    Vanholder, T; Papen, J; Bemers, R; Vertenten, G; Berge, A C B

    2015-02-01

    Ketosis is associated with many transition cow diseases and the subclinical form has been found to be a common condition in high-producing dairy cows. The objectives of this field study in the Netherlands were (1) to determine risk factors for subclinical ketosis [SCK; 1.2-2.9mmol of β-hydroxybutyrate (BHBA)/L of serum] and clinical ketosis (CK: ≥3.0mmol of BHBA/L of serum) at 7 to 14 d in milk and (2) to assess the association of SCK and CK with production parameters at the first dairy herd improvement (DHI) testing. Twenty-three dairies were enrolled by a local veterinary practice from 2009 to 2010, and 1,715 cows were screened for ketosis by measuring serum BHBA concentrations at 7 to 14 d in milk. Overall, 47.2% of cows had SCK and 11.6% had CK. Mixed generalized logit models with a random effect of herd were used to evaluate cow level factors associated with SCK and CK. The associations of SCK and CK with milk production parameters were tested using mixed linear models with a random effect of herd. Cows at a moderate (3.25-3.75) or fat (≥4) body condition score before calving were more likely to develop SCK and CK than thin (body condition score≤3.0) cows. The risk for developing SCK was higher in parity 2 and older cows compared with heifers, whereas for CK only, parity ≥3 cows had a higher risk. The quarter of the year in which a cow calved was associated with the risk for SCK and CK. For SCK quarter 1 (January-March) and quarter 2 (April-June), and for CK quarter 1, quarter 2, and quarter 3 (July-September) all increased the risk of development of the condition compared with quarter 4 (October-December). An increased yield of colostrum at first milking was associated with increasing risk for SCK and CK. Prolonged previous lactation length and dry period length were both associated with increased odds for SCK and CK. Subclinical ketosis and CK were associated with a higher milk yield, a higher milk fat percentage, and a lower milk protein percentage

  8. Mycophenolate mofetil prevents a clinical relapse in patients with systemic lupus erythematosus at risk

    PubMed Central

    Bijl, M; Horst, G; Bootsma, H; Limburg, P; Kallenberg, C

    2003-01-01

    Background: Systemic lupus erythematosus (SLE) is characterised by the presence of antibodies to double stranded DNA (dsDNA), which are involved in the pathogenesis of SLE. Previous studies showed that at least two thirds of patients develop a clinical relapse within six months after a significant rise in the anti-dsDNA level, and most relapses were prevented by the administration of corticosteroids at the time of the rise. Objective: To determine whether mofetil mycophenolate (MMF) can prevent a clinical relapse without the side effects associated with corticosteroids. Methods: 36 patients with SLE were examined monthly to determine whether a rise in anti-dsDNA level had occurred. A rise was defined as an increase of 25% of the level of the previous sample of at least 15 IU/ml within a four month period. After a rise patients were treated with MMF 2000 mg daily for six months. Patients were monitored monthly for the occurrence of a clinical relapse and to assess the serological activity and state of activation of CD4+, CD8+, and CD19+ lymphocyte subsets. Results: Anti-dsDNA rose in 10 patients. Treatment with MMF was started in all these patients, and after six months no clinical relapse had occurred. Side effects were minimal. Antibodies to dsDNA decreased during the treatment (p<0.001), associated with a decrease in the state of activation of CD19+ lymphocytes. No changes were found in the state of activation of CD4+ or CD8+ lymphocyte subsets. Conclusion: Administration of MMF after a rise in antibodies to dsDNA is well tolerated, decreases anti-dsDNA and B cell activation, and seems to prevent the occurrence of a clinical relapse in patients with SLE. PMID:12759290

  9. Increasing the clinical efficacy of NK and antibody-mediated cancer immunotherapy: potential predictors of successful clinical outcome based on observations in high-risk neuroblastoma.

    PubMed

    Koehn, Tony A; Trimble, Lori L; Alderson, Kory L; Erbe, Amy K; McDowell, Kimberly A; Grzywacz, Bartosz; Hank, Jacquelyn A; Sondel, Paul M

    2012-01-01

    Disease recurrence is frequent in high-risk neuroblastoma (NBL) patients even after multi-modality aggressive treatment [a combination of chemotherapy, surgical resection, local radiation therapy, autologous stem cell transplantation, and cis-retinoic acid (CRA)]. Recent clinical studies have explored the use of monoclonal antibodies (mAbs) that bind to disialoganglioside (GD(2)), highly expressed in NBL, as a means to enable immune effector cells to destroy NBL cells via antibody-dependent cell-mediated cytotoxicity (ADCC). Preclinical data indicate that ADCC can be more effective when appropriate effector cells are activated by cytokines. Clinical studies have pursued this by administering anti-GD(2) mAb in combination with ADCC-enhancing cytokines (IL2 and GM-CSF), a regimen that has demonstrated improved cancer-free survival. More recently, early clinical studies have used a fusion protein that consists of the anti-GD(2) mAb directly linked to IL2, and anti-tumor responses were seen in the Phase II setting. Analyses of genes that code for receptors that influence ADCC activity and natural killer (NK) cell function [Fc receptor (FcR), killer immunoglublin-like receptor (KIR), and KIR-ligand (KIR-L)] suggest patients with anti-tumor activity are more likely to have certain genotype profiles. Further analyses will need to be conducted to determine whether these genotypes can be used as predictive markers for favorable therapeutic outcome. In this review, we discuss factors that affect response to mAb-based tumor therapies such as hu14.18-IL2. Many of our observations have been made in the context of NBL; however, we will also include some observations made with mAbs targeting other tumor types that are consistent with results in NBL. Therefore, we hypothesize that the NBL observations discussed here may also be relevant to mAb therapy for other cancers, in which ADCC is known to play a role.

  10. Retrospective Comparison of External Beam Radiotherapy and Radical Prostatectomy in High-Risk, Clinically Localized Prostate Cancer

    SciTech Connect

    Arcangeli, Giorgio; Strigari, Lidia; Arcangeli, Stefano; Petrongari, Maria Grazia; Saracino, Biancamaria; Gomellini, Sara; Papalia, Rocco; Simone, Giuseppe; De Carli, Piero; Gallucci, Michele

    2009-11-15

    Purpose: Because of the lack of conclusive and well-conducted randomized studies, the optimal therapy for prostate tumors remains controversial. The aim of this study was to retrospectively compare the results of radical surgery vs. a conservative approach such as external beam radiotherapy (EBRT) plus androgen deprivation therapy using an intent-to-treat analysis on two pretreatment defined, concurrently treated, high-risk patient populations. Methods and Materials: Between January 2003 and December 2007, 162 patients with high-risk prostate cancer underwent an EBRT plus androgen deprivation therapy program at the RT department of our institute. In the same period, 122 patients with the same high-risk disease underwent radical prostatectomy (RP) at the urologic department of our institute. Patients with adverse pathologic factors also underwent adjuvant EBRT with or without androgen deprivation therapy. The primary endpoint was freedom from biochemical failure. Results: The two groups of high-risk patients were homogeneous in terms of freedom from biochemical failure on the basis of the clinical T stage, biopsy Gleason score, and initial prostate-specific antigen level. The median follow-up was 38.6 and 33.8 months in the EBRT and RP groups, respectively. The actuarial analysis of the freedom from biochemical failure showed a 3-year rate of 86.8% and 69.8% in the EBRT and RP group, respectively (p = .001). Multivariate analysis of the whole group revealed the initial prostate-specific antigen level and treatment type (EBRT vs. RP) as significant covariates. Conclusion: This retrospective intention-to-treat analysis showed a significantly better outcome after EBRT than after RP in patients with high-risk prostate cancer, although a well-conducted randomized comparison would be the best procedure to confirm these results.

  11. Clinical Experience Using the Mann Assessment of Swallowing Ability for Identification of Patients at Risk for Aspiration in a Mixed-Disease Population

    ERIC Educational Resources Information Center

    Gonzalez-Fernandez, Marlis; Sein, Michael T.; Palmer, Jeffrey B.

    2011-01-01

    Purpose: To determine the clinical performance characteristics of the Mann Assessment of Swallowing Ability (MASA) for predicting aspiration (determined by videofluoroscopic swallowing study [VFSS]) in a mixed population. Method: We selected 133 cases clinically evaluated using MASA and VFSS from January through June 2007. Ordinal risk rating…

  12. Clinical validation of the Abbott RealTime High Risk HPV assay according to the guidelines for human papillomavirus DNA test requirements for cervical screening.

    PubMed

    Hesselink, A T; Meijer, C J L M; Poljak, M; Berkhof, J; van Kemenade, F J; van der Salm, M L; Bogaarts, M; Snijders, P J F; Heideman, D A M

    2013-07-01

    This study showed that the Abbott RealTime High Risk HPV assay fulfilled cross-sectional clinical equivalence and reproducibility criteria of international consensus guidelines, which indicates that this assay can be considered clinically validated for cervical cancer screening purposes.

  13. Early onset type 2 diabetes: risk factors, clinical impact and management

    PubMed Central

    Idris, Iskandar

    2014-01-01

    Early onset type 2 diabetes mellitus (T2DM) is increasingly prevalent with a significant impact on the individual, healthcare service delivery and planning. The individuals are likely to be obese, lead a sedentary lifestyle, have a strong family history of T