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Sample records for 4-item clinical risk

  1. The 4-Item Negative Symptom Assessment (NSA-4) Instrument

    PubMed Central

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

    2010-01-01

    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. PMID:20805916

  2. Clinical pharmacology and vascular risk.

    PubMed

    Silvestrelli, G; Corea, F; Micheli, S; Lanari, A

    2010-01-01

    Pharmacological treatment and several drugs of abuse have been associated with ischemic heart disease (IHD) and cerebrovascular diseases (CVD). However, there is a paucity of data on the independent risk of vascular disease (VD) associated with pharmacological treatment and no controlled trials demonstrating a reduction in risk with abstinence. Information about IHD and CVD-related drug abuse is mainly limited to epidemiological studies focused on urban populations. The potential link between some pharmacological treatments (estrogen, some oncologic drugs and some atypical antipsychotics) and cerebrovascular adverse events was analyzed, but disagreement about an association persists. Drugs of abuse, including cocaine, amphetamines and heroin, have been associated with an increased vascular risk. These drugs can cause abrupt changes in blood pressure, vasculitic-type changes, lead to embolization caused by infective endocarditis, and hemostatic and hematologic abnormalities that can result in increased blood viscosity and platelet aggregation. Long-term treatment strategies based on medication, psychological support, and outreach programs play an important role in treatment of drug dependency. In these last years public interest in risk factors for VD has been constantly increasing and the successful identification and management of pharmacological treatment and drug abuse can be challenging. One of the major public health issues for the future will be to focus more on new vascular risk factor recognition and management. The objective of this chapter is to review the relevance of IHD and CVD associated with various pharmacological treatments and drug abuse with focusing on ischemic disease. This chapter reports the clinical evidence of this association and analyzes the experimental role of new drugs as a growing risk factor of VD with the hypothetical new association. In conclusion, in this chapter great attention is paid to evaluating the scientific and real

  3. Clinical risk scores to guide perioperative management.

    PubMed

    Barnett, Sarah; Moonesinghe, Suneetha Ramani

    2011-08-01

    Perioperative morbidity is associated with reduced long term survival. Comorbid disease, cardiovascular illness, and functional capacity can predispose patients to adverse surgical outcomes. Accurate risk stratification would facilitate informed patient consent and identify those individuals who may benefit from specific perioperative interventions. The ideal clinical risk scoring system would be objective, accurate, economical, simple to perform, based entirely on information available preoperatively, and suitable for patients undergoing both elective and emergency surgery. The POSSUM (Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity) scoring systems are the most widely validated perioperative risk predictors currently utilised; however, their inclusion of intra- and postoperative variables precludes validation for preoperative risk prediction. The Charlson Index has the advantage of consisting exclusively of preoperative variables; however, its validity varies in different patient cohorts. Risk models predicting cardiac morbidity have been extensively studied, despite the relatively uncommon occurrence of postoperative cardiac events. Probably the most widely used cardiac risk score is the Lee Revised Cardiac Risk Index, although it has limited validity in some patient populations and for non-cardiac outcomes. Bespoke clinical scoring systems responding to dynamic changes in population characteristics over time, such as those developed by the American College of Surgeons National Surgical Quality Improvement Program, are more precise, but require considerable resources to implement. The combination of objective clinical variables with information from novel techniques such as cardiopulmonary exercise testing and biomarker assays, may improve the predictive precision of clinical risk scores used to guide perioperative management. PMID:21257993

  4. Risk Management in the Clinical Laboratory

    PubMed Central

    Njoroge, Sarah W

    2014-01-01

    Clinical laboratory tests play an integral role in medical decision-making and as such must be reliable and accurate. Unfortunately, no laboratory tests or devices are foolproof and errors can occur at pre-analytical, analytical and post-analytical phases of testing. Evaluating possible conditions that could lead to errors and outlining the necessary steps to detect and prevent errors before they cause patient harm is therefore an important part of laboratory testing. This can be achieved through the practice of risk management. EP23-A is a new guideline from the CLSI that introduces risk management principles to the clinical laboratory. This guideline borrows concepts from the manufacturing industry and encourages laboratories to develop risk management plans that address the specific risks inherent to each lab. Once the risks have been identified, the laboratory must implement control processes and continuously monitor and modify them to make certain that risk is maintained at a clinically acceptable level. This review summarizes the principles of risk management in the clinical laboratory and describes various quality control activities employed by the laboratory to achieve the goal of reporting valid, accurate and reliable test results. PMID:24982831

  5. 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

  6. Bleeding Risk Index in an Anticoagulation Clinic

    PubMed Central

    Aspinall, Sherrie L; DeSanzo, Beth E; Trilli, Lauren E; Good, Chester B

    2005-01-01

    BACKGROUND The Outpatient Bleeding Risk Index (BRI) prospectively classified patients who were at high, intermediate, or low risk for warfarin-related major bleeding. However, there are only 2 published validation studies of the index and neither included veterans. OBJECTIVE To determine the accuracy of the BRI in patients attending a Veterans Affairs (VA) anticoagulation clinic and to specifically evaluate the accuracy of the BRI in patients with atrial fibrillation. DESIGN Retrospective cohort study. PATIENTS AND MEASUREMENTS Using the BRI, all patients managed by the Anticoagulation Clinic between January 1, 2001 and December 31, 2002 were classified as high, intermediate, or low risk for major bleeding. Bleeds were identified via quality-assurance reports. Poisson regression was used to determine whether there was an association between the index and the development of bleeding. RESULTS The rate of major bleeding was 10.6%, 2.5%, and 0.8% per patient-year of warfarin in the high-, intermediate-, and low-risk groups, respectively. Patients in the high-risk category had 14 times the rate of major bleeding of those in the low-risk group (incidence rate ratio (IRR) 14; 95% confidence interval (CI), 1.9 to 104.7). The rate of major bleeding was significantly different between the high- and intermediate-risk categories (P<.001). Among those with atrial fibrillation, patients in the high-risk category had 6 times the major bleeding rate of those in the intermediate- and low-risk groups combined (IRR=6; 95% CI, 2.4 to 15.3). CONCLUSIONS The BRI discriminates between high- and intermediate-risk patients in a VA anticoagulation clinic, including those with atrial fibrillation. PMID:16307625

  7. 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

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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.

  14. 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. PMID:24224677

  15. ["Nutritional risk screening 2002"--in clinical pneumology].

    PubMed

    Priegnitz, C; Galetke, W; Treml, M; Randerath, W J

    2014-07-01

    Malnutrition is a frequent problem for hospitalized patients. It is a relevant risk factor for morbidity and mortality. The aim of this study was to detect undernutrition and the risk of malnutrition (RM) in patients admitted to a university-affiliated respiratory care clinic. Undernutrition was assessed by body mass index (BMI<18.5 kg/m²) and RM by using the "Nutritional Risk Screening 2002" (NRS 2002) in 705 consecutive patients (BMI: measured in 689 patients/NRS: 680 patients assessed). Data was analysed with regard to age, sex, length of hospital stay as well as underlying pneumological disorders. In 14.3% of 680 patients, RM was detected by NRS. In 2.5% out of 689 patients, undernutrition was identified by BMI. In patients older than 65 years (n=365), these numbers were 19.6% (NRS) and 1.5% (BMI<18.5 kg/m²). Age was a significant risk factor for RM (OR 1.054 per year). Gender, however, was not associated with undernutrition or RM. In a sub-analysis, RM was more frequent in patients with pneumonia and chronic obstructive lung disease (23% and 16%, respectively). Patients with cancer were more frequently at RM as compared to patients with sleep-disordered breathing (OR: 2.33 in cancer, OR: 0.04 in sleep-disordered breathing). RM was associated with a significant increase in length of hospital stay (10.2 ± 9.5 vs. 5.4 ± 6.0 days). Besides the BMI, the NRS provides a valid tool for screening patients at RM. PMID:24901544

  16. 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

  17. The AFC Score: Validation of a 4-Item Predicting Score of Postoperative Mortality After Colorectal Resection for Cancer or Diverticulitis

    PubMed Central

    Alves, Arnaud; Panis, Yves; Mantion, Georges; Slim, Karem; Kwiatkowski, Fabrice; Vicaut, Eric

    2007-01-01

    Objective: The aim of the present prospective study was to validate externally a 4-item predictive score of mortality after colorectal surgery (the AFC score) by testing its generalizability on a new population. Summary Background Data: We have recently reported, in a French prospective multicenter study, that age older than 70 years, neurologic comorbidity, underweight (body weight loss >10% in <6 months), and emergency surgery significantly increased postoperative mortality after resection for cancer or diverticulitis. Patients and Methods: From June to September 2004, 1049 consecutive patients (548 men and 499 women) with a mean age of 67 ± 14 years, undergoing open or laparoscopic colorectal resection, were prospectively included. The AFC score was validated in this population. We assessed also the predictive value of other scores, such as the “Glasgow” score and the ASA score. To express and compare the predictive value of the different scores, a receiver operating characteristic curve was calculated. Results: Postoperative mortality rate was 4.6%. Variables already identified as predictors of mortality and used in the AFC score were also found to be associated with a high odds ratio in this study: emergency surgery, body weight loss >10%, neurologic comorbidity, and age older than 70 years in a multivariate logistic model. The validity of the AFC score in this population was found very high based both on the Hosmer-Lemeshow goodness of fit test (P = 0.37) and on the area under the ROC curve (0.89). We also found that discriminatory capacity was higher than other currently used risk scoring systems such as the Glasgow or ASA score. Conclusion: The present prospective study validated the AFC score as a pertinent predictive score of postoperative mortality after colorectal surgery. Because it is based on only 4 risk factors, the AFC score can be used in daily practice. PMID:17592296

  18. Managing risk: clinical decision-making in mental health services.

    PubMed

    Muir-Cochrane, Eimear; Gerace, Adam; Mosel, Krista; O'Kane, Debra; Barkway, Patricia; Curren, David; Oster, Candice

    2011-01-01

    Risk assessment and management is a major component of contemporary mental health practice. Risk assessment in health care exists within contemporary perspectives of management and risk aversive practices in health care. This has led to much discussion about the best approach to assessing possible risks posed by people with mental health problems. In addition, researchers and commentators have expressed concern that clinical practice is being dominated by managerial models of risk management at the expense of meeting the patient's health and social care needs. The purpose of the present study is to investigate the risk assessment practices of a multidisciplinary mental health service. Findings indicate that mental health professionals draw on both managerial and therapeutic approaches to risk management, integrating these approaches into their clinical practice. Rather than being dominated by managerial concerns regarding risk, the participants demonstrate professional autonomy and concern for the needs of their clients. PMID:22077745

  19. 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…

  20. Evaluating the Risks of Clinical Research: Direct Comparative Analysis

    PubMed Central

    Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S.; Wendler, David

    2014-01-01

    Abstract Objectives: Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed “risks of daily life” standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. Methods: This study employed a conceptual and normative analysis, and use of an illustrative example. Results: Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the “risks of daily life” standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Conclusions: Direct comparative analysis is a systematic method for applying the “risks of daily life” standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about

  1. Cancer clinical trial participants' assessment of risk and benefit

    PubMed Central

    Ulrich, Connie M.; Ratcliffe, Sarah J.; Wallen, Gwenyth R.; Zhou, Qiuping (Pearl); Knafl, Kathleen; Grady, Christine

    2015-01-01

    Background The purpose of this article is to examine the extent to which cancer clinical trial participants assess the benefits and risks of research participation before enrollment. Methods One hundred and ten oncology research participants enrolled in cancer clinical research in a large Northeastern cancer center responded to a self-administered questionnaire on perceptions about cancer clinical trials. Results Of the participants, 51.6% reported they did not directly assess the benefits or risks. Educational level, age, employment, treatment options, insurance, and spiritual–religious beliefs were significantly associated with whether participants assessed risk and benefits. Those who felt well informed were more likely to have assessed the benefits and risks at enrollment than those who did not feel well informed (odds ratio [OR] = 3.92, p = .014); of those who did not assess the risks and benefits, 21% did not feel well informed at enrollment (p = .001). Those who agreed that the clinical trial helped pay the costs of the care had nearly three times the odds of not assessing risks and benefits compared to those who disagreed. Conclusion Our findings have important implications for understanding the role of assessing risks and benefits in the research participation decisions of patients with cancer and call for further understanding of why participants are not assessing information believed to be essential for autonomous informed decisions. PMID:26709381

  2. Introduction and Clinical Overview of the DVH Risk Map.

    PubMed

    Asbell, Sucha O; Grimm, Jimm; Xue, Jinyu; Chew, Meng-Sang; LaCouture, Tamara A

    2016-04-01

    Radiation oncologists need reliable estimates of risk for various fractionation schemes for all critical anatomical structures throughout the body, in a clinically convenient format. Reliable estimation theory can become fairly complex, however, and estimates of risk continue to evolve as the literature matures. To navigate through this efficiently, a dose-volume histogram (DVH) Risk Map was created, which provides a comparison of radiation tolerance limits as a function of dose, fractionation, volume, and risk level. The graphical portion of the DVH Risk Map helps clinicians to easily visualize the trends, whereas the tabular portion provides quantitative precision for clinical implementation. The DVH Risk Map for rib tolerance from stereotactic ablative body radiotherapy (SABR) and stereotactic body radiation therapy (SBRT) is used as an example in this overview; the 5% and 50% risk levels for 1-5 fractions for 5 different volumes are given. Other articles throughout this issue of Seminars in Radiation Oncology present analysis of new clinical datasets including the DVH Risk Maps for other anatomical structures throughout the body. PMID:27000504

  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. Clinical Risk Prediction by Exploring High-Order Feature Correlations

    PubMed Central

    Wang, Fei; Zhang, Ping; Wang, Xiang; Hu, Jianying

    2014-01-01

    Clinical risk prediction is one important problem in medical informatics, and logistic regression is one of the most widely used approaches for clinical risk prediction. In many cases, the number of potential risk factors is fairly large and the actual set of factors that contribute to the risk is small. Therefore sparse logistic regression is proposed, which can not only predict the clinical risk but also identify the set of relevant risk factors. The inputs of logistic regression and sparse logistic regression are required to be in vector form. This limits the applicability of these models in the problems when the data cannot be naturally represented vectors (e.g., medical images are two-dimensional matrices). To handle the cases when the data are in the form of multi-dimensional arrays, we propose HOSLR: High-Order Sparse Logistic Regression, which can be viewed as a high order extension of sparse logistic regression. Instead of solving one classification vector as in conventional logistic regression, we solve for K classification vectors in HOSLR (K is the number of modes in the data). A block proximal descent approach is proposed to solve the problem and its convergence is guaranteed. Finally we validate the effectiveness of HOSLR on predicting the onset risk of patients with Alzheimer’s disease and heart failure. PMID:25954428

  5. 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

  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. Breast cancer risk during hormone therapy: experimental versus clinical data.

    PubMed

    Ruan, X; Seeger, H; Mueck, A O

    2012-03-01

    Evidence is increasing suggesting that adding progestogens to estrogens can increase the risk of breast cancer. However, our experimental data as a result of scientific collaboration between university of Tuebingen, Germany, and university of Beijing, China, comparing all available progestogens used in hormone therapy and hormonal contraception present high evidence that there may be differences regarding breast cancer risk. Especially of concern may be to differentiate between primary and secondary risk i.e. between the effect of on benign and malignant breast epithelial cells suggesting differences in primary risk and risk in patients after breast cancer. Of importance also is that in contrast to natural progesterone the apocrine impact of stromal growth factors and also certain cell components of breast epithelial cells can strongly increase proliferation rates of some (but not all. synthetic progestogens which can lead to clinical cancer before (in contrast to estrogen-only therapy. carcinoprotective mechanisms can work. Regarding clinical data, epidemiological studies and especially the Women's Health Initiative, so far the only prospective placebo-controlled study, demonstrate an increased risk under combined estrogen/progestogen-, but not under estrogen-only therapy. However, up to now the clinical studies cannot discriminate between the various progestogens mostly due to too small patient numbers in the subgroups, and in most studies either medroxyprogesterone acetate or norethisterone have been used. However, there is evidence that the natural progesterone and dydrogesterone, possibly also the transdermal usage of synthetic progestogens, may have less risks, but this must be proven in further clinical trials. PMID:22382615

  9. Automating risk of bias assessment for clinical trials.

    PubMed

    Marshall, Iain J; Kuiper, Joël; Wallace, Byron C

    2015-07-01

    Systematic reviews, which summarize the entirety of the evidence pertaining to a specific clinical question, have become critical for evidence-based decision making in healthcare. But such reviews have become increasingly onerous to produce due to the exponentially expanding biomedical literature base. This study proposes a step toward mitigating this problem by automating risk of bias assessment in systematic reviews, in which reviewers determine whether study results may be affected by biases (e.g., poor randomization or blinding). Conducting risk of bias assessment is an important but onerous task. We thus describe a machine learning approach to automate this assessment, using the standard Cochrane Risk of Bias Tool which assesses seven common types of bias. Training such a system would typically require a large labeled corpus, which would be prohibitively expensive to collect here. Instead, we use distant supervision, using data from the Cochrane Database of Systematic Reviews (a large repository of systematic reviews), to pseudoannotate a corpus of 2200 clinical trial reports in PDF format. We then develop a joint model which, using the full text of a clinical trial report as input, predicts the risks of bias while simultaneously extracting the text fragments supporting these assessments. This study represents a step toward automating or semiautomating extraction of data necessary for the synthesis of clinical trials. PMID:25966488

  10. 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.…

  11. 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)

  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

    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

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

    PubMed

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

    2016-06-01

    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 clinical encounter. Participant median age was 5.8 years, 76.1 % were male, and most participants had an intelligence/developmental quotient score >85; 69 of the participants (31 %) received a clinical diagnosis of ASD. The sensitivity of the MARA in detecting ASD was 89.9 % [95 % CI = 82.7-97]; the specificity was 79.7 % [95 % CI = 73.4-86.1]. In a high-risk clinical setting, the MARA shows promise as a screen to distinguish ASD from other developmental/behavioral disorders. PMID:26873142

  15. 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

  16. Clinical Symptoms and Risk Factors in Cerebral Microangiopathy Patients

    PubMed Central

    Okroglic, Sandra; Widmann, Catherine N.; Urbach, Horst; Scheltens, Philip; Heneka, Michael T.

    2013-01-01

    Objective Although the clinical manifestation and risk factors of cerebral microangiopathy (CM) remain unclear, the number of diagnoses is increasing. Hence, patterns of association among lesion topography and severity, clinical symptoms and demographic and disease risk factors were investigated retrospectively in a cohort of CM patients. Methods Patients treated at the Department of Neurology, University of Bonn for CM (n = 223; 98m, 125f; aged 77.32±9.09) from 2005 to 2010 were retrospectively enrolled. Clinical symptoms, blood chemistry, potential risk factors, demographic data and ratings of vascular pathology in the brain based on the Wahlund scale were analyzed using Pearson's chi square test and one-way ANOVA. Results Progressive cognitive decline (38.1%), gait apraxia (27.8%), stroke-related symptoms and seizures (24.2%), TIA-symptoms (22%) and vertigo (17%) were frequent symptoms within the study population. Frontal lobe WMLs/lacunar infarcts led to more frequent presentation of progressive cognitive decline, seizures, gait apraxia, stroke-related symptoms, TIA, vertigo and incontinence. Parietooccipital WMLs/lacunar infarcts were related to higher frequencies of TIA, seizures and incontinence. Basal ganglia WMLs/lacunar infarcts were seen in patients with more complaints of gait apraxia, vertigo and incontinence. Age (p = .012), arterial hypertension (p<.000), obesity (p<.000) and cerebral macroangiopathy (p = .018) were positively related to cerebral lesion load. For increased glucose level, homocysteine, CRP and D-Dimers there was no association. Conclusion This underlines the association of CM with neurological symptoms upon admission in a topographical manner. Seizures and vertigo are symptoms of CM which may have been missed in previous studies. In addition to confirming known risk factors such as aging and arterial hypertension, obesity appears to increase the risk as well. Since the incidence of CM is increasing, future studies should

  17. 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

  18. 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

  19. Presumed Perinatal Stroke: Risk Factors, Clinical and Radiological Findings.

    PubMed

    Ilves, Pilvi; Laugesaar, Rael; Loorits, Dagmar; Kolk, Anneli; Tomberg, Tiiu; Lõo, Silva; Talvik, Inga; Kahre, Tiina; Talvik, Tiina

    2016-04-01

    It is unknown why some infants with perinatal stroke present clinical symptoms late during infancy and will be identified as infants with presumed perinatal stroke. The risk factors and clinical and radiological data of 42 infants with presumed perinatal stroke (69% with periventricular venous infarction and 31% with arterial ischemic stroke) from the Estonian Pediatric Stroke Database were reviewed. Children with presumed perinatal stroke were born at term in 95% of the cases and had had no risk factors during pregnancy in 43% of the cases. Children with periventricular venous infarction were born significantly more often (82%) vaginally (P = .0213) compared to children with arterial stroke (42%); nor did they require resuscitation (P = .0212) or had any neurological symptoms after birth (P = .0249). Periventricular venous infarction is the most common type of lesion among infants with the presumed perinatal stroke. Data suggest that the disease is of prenatal origin. PMID:26446909

  20. Multiple risk factor evaluation in a hypertension clinic.

    PubMed

    Thom, S; Bunker, J; Callister, W; Poulter, N; Sever, P; Zographos, D

    1989-12-01

    Hypertension is associated with abnormal lipoprotein metabolism, which may be exacerbated by some groups of antihypertensive drugs and represents an additional powerful coronary heart disease risk factor. Of our Hypertension Clinic population, 75% had a total fasting serum cholesterol greater than 5.2 mmol/l. Dietary advice and adjustment of antihypertensive therapy has achieved significant reductions in total cholesterol, serum triglycerides and body weight (14%, 18% and 4.3%, respectively) in a cohort of 65 patients reassessed over a period of 3-21 months. The reduction in cholesterol is likely to represent at least a 28% reduction in the risk of a major coronary heart disease event, even before taking account of any improvement in other coronary heart disease risk factors. PMID:2632734

  1. Laboratory and clinical risk assessment to treat myelodysplatic syndromes.

    PubMed

    Gidaro, Antonio; Deliliers, Giorgio Lambertenghi; Gallipoli, Paolo; Arquati, Massimo; Wu, Maddalena Alessandra; Castelli, Roberto

    2016-09-01

    Myelodisplastic syndromes (MDS) are heterogeneous myeloid disorders characterized by peripheral cytopenias and increased risk of transformation into acute myelogenous leukemia (AML). MDS are generally suspected in the presence of cytopenia on routine analysis and the evaluation of bone marrow cells morphology and cellularity leads to correct diagnosis of MDS. The incidence of MDS is approximately five cases per 100,000 people per year in the general population, but it increases up to 50 cases per 100,000 people per year after 60 years of age. Typically MDS affect the elderly, with a median age at diagnosis of 65-70 years. Here the current therapeutic approaches for MDS are evaluated by searching the PubMed database. Establishing the prognosis in MDS patients is a key element of therapy. In fact an accurate estimate of prognosis drives decisions about the choice and timing of the therapeutic options. Therapy is selected based on prognostic risk assessment, cytogenetic pattern, transfusion needs and biological characteristics of the disease, comorbidities and clinical condition of the patients. In lower-risk patients the goals of therapy are different from those in higher-risk patients. In lower-risk patients, the aim of therapy is to reduce transfusion needs and transformation to higher risk disease or AML, improving the quality of life and survival. In higher-risk patients, the main goal of therapy is to prolong survival and to reduce the risk of AML transformation. Current therapies include growth factor support, lenalidomide, immunomodulatory and hypomethylating agents, intensive chemotherapy, and allogenic stem cell transplantation. The challenge when dealing with MDS patients is to select the optimal treatment by balancing efficacy and toxicity. PMID:26812791

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Clinical Prediction of Fall Risk and White Matter Abnormalities

    PubMed Central

    Koo, Bang-Bon; Bergethon, Peter; Qiu, Wei Qiao; Scott, Tammy; Hussain, Mohammed; Rosenberg, Irwin; Caplan, Louis R.; Bhadelia, Rafeeque A.

    2015-01-01

    Background 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 determined by the Tinetti scale, have specific patterns of WM abnormalities on diffusion tensor imaging. Design, Setting, and Patients Community-based cohort of 125 homebound elderly individuals. Main Outcome Measures Diffusion tensor imaging scans were analyzed using tract-based spatial statistics analysis to determine the location of WM abnormalities in subjects with Tinetti scale scores of 25 or higher (without risk of falls) and lower than 25 (with risk of falls). Multivariate linear least squares correlation analysis was performed to determine the association between Tinetti scale scores and local fractional anisotropy values on each skeletal voxel controlling for possible confounders. Results In subjects with risk of falls (Tinetti scale score <25), clusters of abnormal WM were seen in the medial frontal and parietal subcortical pathways, genu and splenium of corpus callosum, posterior cingulum, prefrontal and orbitofrontal pathways, and longitudinal pathways that connect frontal-parietal-temporal lobes. Among these abnormalities, those in medial frontal and parietal subcortical pathways correlated with Mini-Mental State Examination scores, while the other locations were unrelated to these scores. Conclusions Elderly individuals at risk for falls as determined by the Tinetti scale have WM abnormalities in specific locations on diffusion tensor imaging, some of which correlate with cognitive function scores. PMID:22332181

  8. The prodrome and clinical risk for psychotic disorders.

    PubMed

    Goulding, Sandra M; Holtzman, Carrie W; Trotman, Hanan D; Ryan, Arthur T; Macdonald, Allison N; Shapiro, Daniel I; Brasfield, Joy L; Walker, Elaine F

    2013-10-01

    The psychosis prodrome offers great promise for identifying neural mechanisms involved in psychotic disorders and offers an opportunity to implement empirical interventions to delay, and ultimately ameliorate, illness onset. This article summarizes the literature on individuals in the putatively prodromal phase of psychosis/deemed at clinical high risk (CHR) for psychosis onset. Standardized measurement and manifestation of the CHR syndromes are discussed, followed by empirical findings that highlight the psychological deficits and biological abnormalities seen in CHR syndromes and psychotic disorders. Current controversies surrounding the diagnosis of CHR syndromes and issues related to the treatment of CHR individuals are also presented. PMID:24012073

  9. 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

  10. How do chiropractors manage clinical risk? A questionnaire study

    PubMed Central

    2013-01-01

    Background The literature on chiropractic safety tends to focus on adverse events and little is known about how chiropractors ensure safety and manage risk in the course of their daily practice. The purpose of this study was to investigate how chiropractors manage potentially risky clinical scenarios. We also sought to establish how chiropractors perceive the safety climate in their workplace and thus whether there is an observable culture of safety within the profession. Methods An online questionnaire was designed to determine which of nine management options would be chosen by the respondent in response to four defined clinical case scenarios. Safety climate within the respondent’s practice setting was measured by seeking the level of agreement with 23 statements relating to six different safety dimensions. 260 licensed chiropractors in Switzerland and 1258 UK members of The Royal College of Chiropractors were invited to complete the questionnaire. Questionnaire responses were analysed quantitatively in respect of the four clinical scenarios and the nine management options to determine the likelihood of each option being undertaken, with results recorded in terms of % likelihood. Gender differences in response to the management options for each scenario were evaluated using the Mann–Whitney U (MWU) test. Positive agreement with elements comprising each of the six safety dimensions contributed to a composite ‘% positive agreement’ score calculated for each dimension. Results Questionnaire responses were received from 76% (200/260) of Swiss participants and 31% (393/1258) of UK members of The Royal College of Chiropractors. There was a general trend for Swiss and UK chiropractors to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a patient is apparently getting worse, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system

  11. Giardia intestinalis genotypes: Risk factors and correlation with clinical symptoms.

    PubMed

    Mohammed Mahdy, A K; Surin, Johari; Wan, K L; Mohd-Adnan, A; Al-Mekhlafi, M S Hesham; Lim, Y A L

    2009-10-01

    This study was conducted to identify genotypes related risk factors of Giardia intestinalis in an Orang Asli (aboriginal) community in Pahang, Malaysia. Stool samples were collected from 321 individuals aged between 2 and 76 years old, of whom 160 were males and 161 were females. Faecal samples were processed with trichrome staining technique for the primary identification of G. intestinalis. Molecular identification was carried out by the amplification of a partial SSU rRNA gene using nested PCR. PCR products were purified and genotyped. 42 samples successfully amplified from the 76 positive faecal samples, only 1 was Assemblage A, the rest were Assemblage B. Risk analysis based on the detected genotypes of Giardia using univariate analysis and logistic regression identified three significant risk factors of giardiasis caused by assemblage B which included children clinical symptoms of giardiasis (OR=2.4, 95% CI=1.13-5.12, p=0.019). Females infected with Assemblage B were at higher risk of manifesting gastroenteritis signs and symptoms (OR=3.9, 95% CI=1.50-10.31, p=0.004). It has been concluded that giardiasis is still a public health problem in Orang Asli community and most commonly caused by assemblage B. The dynamic of transmission is most probably anthroponotic which is human to human either directly or indirectly through contaminated food. This route of transmission should be considered in the control strategy of the disease. Mass treatment together with health education could be the most practical intervention for reducing the infection. Those at high risk should receive more attention from public health authorities. PMID:19560431

  12. 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

  13. 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

  14. 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

  15. 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. PMID:20805916

  16. Cyberbullying in those at Clinical High Risk for psychosis

    PubMed Central

    Magaud, Emilie; Nyman, Karissa; Addington, Jean

    2012-01-01

    Aim Several studies suggest an association between experiences of childhood trauma including bullying and the development of psychotic symptoms. The use of communications technology has created a new media for bullying called ‘cyberbullying’. Research has demonstrated associations between traditional bullying and cyberbullying. Negative effects of cyberbullying appear similar in nature and severity to the reported effects of traditional bullying. Our aim was to examine the prevalence and correlates of cyberbullying in those at clinical high risk (CHR) for psychosis. Methods Fifty young people at CHR for psychosis were administered the Childhood Trauma Questionnaire with added questions about cyberbullying. Results Cyberbullying was reported in 38% of the sample. Those who experienced cyberbullying also reported experiencing previous trauma. Conclusion It is possible that cyberbullying may be a problem for those at CHR of psychosis and due to the vulnerable nature of these young people, may have longitudinal implications. PMID:23343259

  17. 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

  18. 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

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

    PubMed

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

    2016-03-01

    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

  20. 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

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

    PubMed

    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

  2. Simplifying clinical use of the genetic risk prediction model BRCAPRO.

    PubMed

    Biswas, Swati; Atienza, Philamer; Chipman, Jonathan; Hughes, Kevin; Barrera, Angelica M Gutierrez; Amos, Christopher I; Arun, Banu; Parmigiani, Giovanni

    2013-06-01

    Health care providers need simple tools to identify patients at genetic risk of breast and ovarian cancers. Genetic risk prediction models such as BRCAPRO could fill this gap if incorporated into Electronic Medical Records or other Health Information Technology solutions. However, BRCAPRO requires potentially extensive information on the counselee and her family history. Thus, it may be useful to provide simplified version(s) of BRCAPRO for use in settings that do not require exhaustive genetic counseling. We explore four simplified versions of BRCAPRO, each using less complete information than the original model. BRCAPROLYTE uses information on affected relatives only up to second degree. It is in clinical use but has not been evaluated. BRCAPROLYTE-Plus extends BRCAPROLYTE by imputing the ages of unaffected relatives. BRCAPROLYTE-Simple reduces the data collection burden associated with BRCAPROLYTE and BRCAPROLYTE-Plus by not collecting the family structure. BRCAPRO-1Degree only uses first-degree affected relatives. We use data on 2,713 individuals from seven sites of the Cancer Genetics Network and MD Anderson Cancer Center to compare these simplified tools with the Family History Assessment Tool (FHAT) and BRCAPRO, with the latter serving as the benchmark. BRCAPROLYTE retains high discrimination; however, because it ignores information on unaffected relatives, it overestimates carrier probabilities. BRCAPROLYTE-Plus and BRCAPROLYTE-Simple provide better calibration than BRCAPROLYTE, so they have higher specificity for similar values of sensitivity. BRCAPROLYTE-Plus performs slightly better than BRCAPROLYTE-Simple. The Areas Under the ROC curve are 0.783 (BRCAPRO), 0.763 (BRCAPROLYTE), 0.772 (BRCAPROLYTE-Plus), 0.773 (BRCAPROLYTE-Simple), 0.728 (BRCAPRO-1Degree), and 0.745 (FHAT). The simpler versions, especially BRCAPROLYTE-Plus and BRCAPROLYTE-Simple, lead to only modest loss in overall discrimination compared to BRCAPRO in this dataset. Thus, we conclude that

  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. 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. PMID:26435140

  5. Excimer laser coronary angioplasty: relative risk analysis of clinical results

    NASA Astrophysics Data System (ADS)

    Bittl, John A.

    1992-08-01

    Reports of successful use of excimer laser coronary angioplasty for complex coronary artery disease abound, yet firm indications for its use have not been defined. We attempted to treat 858 coronary stenoses in 764 consecutive patients (mean age 61 years; range 32 - 91 years; 75% men; 76% with Class III or IV angina) with excimer laser angioplasty at 308 nm. Successful treatment was achieved in 86% of patients, as indicated by risk analysis. This showed that certain angiographic features, such as lesions at a vessel bifurcation (odds ratio, OR equals 0.46; 95% confidence interval 0.23, 0.88; P equals 0.017;) or in a tortuous segment (OR equals 0.54; 95% CI equals 0.34, 0.88; P equals 0.041), have decreased likelihood of clinical success. On the other hand, ostial stenoses (OR equals 1.06; 95% CI equals 0.44, 2.56, P equals 0.903) and saphenous vein graft lesions (OR equals 2.17; 95% CI equals 0.98, 4.82; P equals 0.051) have acceptable success rates. Diffuse disease (> 20 mm), total occlusions and calcified lesions were treated as successfully as all other lesion types. Successful treatment with excimer laser coronary angioplasty was also achieved in almost all patients (15/16) who had a prior unsuccessful attempt at balloon angioplasty in the lesion was crossed with a guidewire yet resists either balloon catheter passage or full dilatation. Follow-up angiography was obtained in 70% of eligible patients. Angiographic restenosis, defined by > 50% stenosis, was seen in 60% of patients. Relative risk analysis showed an increased risk of restenosis when adjunctive balloon angioplasty was not used (OR equals 1.68; 95% CI equals 1.02, 2.28; P equals 0.039). Other variables known to affect the outcome of balloon angioplasty, such as lesion length or stenosis in degenerated saphenous vein bypass graft, did not influence the

  6. 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

  7. 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...

  8. 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

  9. Clinical engineering and risk management in healthcare technological process using architecture framework.

    PubMed

    Signori, Marcos R; Garcia, Renato

    2010-01-01

    This paper presents a model that aids the Clinical Engineering to deal with Risk Management in the Healthcare Technological Process. The healthcare technological setting is complex and supported by three basics entities: infrastructure (IS), healthcare technology (HT), and human resource (HR). Was used an Enterprise Architecture - MODAF (Ministry of Defence Architecture Framework) - to model this process for risk management. Thus, was created a new model to contribute to the risk management in the HT process, through the Clinical Engineering viewpoint. This architecture model can support and improve the decision making process of the Clinical Engineering to the Risk Management in the Healthcare Technological process. PMID:21096536

  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. Risks, dangers and competing clinical decisions on venous thromboembolism prophylaxis in hospital care.

    PubMed

    Boiko, Olga; Sheaff, Rod; Child, Susan; Gericke, Christian A

    2014-07-01

    Drawing on wider sociologies of risk, this article examines the complexity of clinical risks and their management, focusing on risk management systems, expert decision-making and safety standards in health care. At the time of this study preventing venous thromboembolism (VTE) among in-patients was one of the top priorities for hospital safety in the English National Health Service (NHS). An analysis of 50 interviews examining hospital professionals' perceptions about VTE risks and prophylaxis illuminates how National Institute for Health and Clinical Excellence (NICE) guidelines influenced clinical decision-making in four hospitals in one NHS region. We examine four themes: the identification of new risks, the institutionalisation and management of risk, the relationship between risk and danger and the tensions between risk management systems and expert decision-making. The implementation of NICE guidelines for VTE prevention extended managerial control over risk management but some irreducible clinical dangers remained that were beyond the scope of the new VTE risk management systems. Linking sociologies of risk with the realities of hospital risk management reveals the capacity of these theories to illuminate both the possibilities and the limits of managerialism in health care. PMID:24635764

  12. Clinical risk factors for fracture in postmenopausal Canadian women: a population-based prevalence study.

    PubMed

    Leslie, William D; Anderson, William A; Metge, Colleen J; Manness, Lori-Jean

    2007-04-01

    Clinical risk factor assessment can be used to enhance fracture risk estimation based upon bone densitometry alone. Population- and age-specific risk factor prevalence data are required for the construction of these risk models. Our objective was to derive population-based prevalence estimates of specific clinical risk factors for postmenopausal women resident in the Province of Manitoba, Canada. A random sample of 40,300 women age 50 or older identified from the provincial health plan was mailed a validated self-report risk factor survey. The response rate was 8747 (21.7%) with a final study population of 8027 women after exclusions. The individual prevalence for each clinical risk factor ranged from 5.8% for hyperthyroidism to 33.0% for a fall in the preceding 12 months. Most point prevalence estimates were similar to other large cohort studies, though the prevalences of inactivity and poor mobility were higher than expected while height at age 25 and the prevalence of any fracture after age 50 were lower than expected. Most of the respondents (86.9%) had at least one non-age clinical risk factor, 60.6% had two or more, and 33.5% had three or more. Age affected risk factor prevalence, and older age was associated with a higher rate of multiple risk factors. The availability of age-specific risk factor prevalence rates in this population may allow for more accurate fracture risk modeling. PMID:17182296

  13. 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. PMID:26108215

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

    PubMed Central

    Wada, Kyoko; Nisker, Jeff

    2015-01-01

    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. PMID:26108215

  15. 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…

  16. 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

  17. 21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Clinical investigations not involving greater than... HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.51 Clinical investigations not involving greater than minimal risk. Any...

  18. 21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Clinical investigations not involving greater than... HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.51 Clinical investigations not involving greater than minimal risk. Any...

  19. 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…

  20. 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

  1. 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

  2. Evaluation of a cardiovascular Risk Reduction Program at a workplace medical clinic.

    PubMed

    Andres, Kara L; Renn, Tracy A; Gray, David A; Englund, Joanne M; Olsen, Geary W; Letourneau, Barbara K

    2013-10-01

    The Cardiovascular Risk Reduction Program (CVRRP) was implemented in the 3M Medical Clinic in December 2009. The goal of the CVRRP was to evaluate 3M employees at risk for developing cardiovascular disease (CVD) and address any related modifiable risk factors with appropriate intervention strategies through clinic visits with a 3M nurse practitioner or physician and, if needed, a registered dietitian and/or exercise professional. Data for the first 100 participants were analyzed to initially assess the effectiveness of the program. Based on this evaluation, the 3M CVRRP and active collaboration between participants and providers in the workplace successfully reduced modifiable CVD risk factors. PMID:24053219

  3. What Are the Possible Benefits and Risks of Clinical Trials?

    MedlinePlus

    ... of questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" Featured Video ... children and their own motivations for pursuing research in this field. Learn more at http://www. ...

  4. Taking apart the art: the risk of anatomizing clinical competence.

    PubMed

    Huddle, Thomas S; Heudebert, Gustavo R

    2007-06-01

    The Accreditation Council for Graduate Medical Education (ACGME) is encouraging medical residency programs to objectively assess their trainees for possession of six general clinical competencies by the completion of residency training. This is the thrust of the ACGME Outcome Project, now in its seventh year. As residency programs seek to integrate the general competencies into clinical training, educators have begun to suggest that objective assessment of clinical competence may be able to guide decisions about length of training and timing of subspecialization. The authors contend that higher-level competence is not amenable to assessment by the objective comparison of resident performance with learning objectives, even if such objectives are derived from general competencies. Present-day attempts at such assessment echo the uses to which medical schools hoped to put curricular learning objectives in the 1970s. Objective assessment may capture knowledge and skills that amount to the "building blocks" of competence, but it cannot elucidate or scrutinize higher-level clinical competence. Higher-level competence involves sensitivity to clinical context and can be validly appraised only in such a context by fully competent clinical appraisers. Such assessment is necessarily subjective, but it need not be unreproducible if raters are trained and if sampling of trainee performance is sufficiently extensive. If the ACGME approach to clinical competency is indeed brought to bear on decisions about training length and subspecialization timing, the present apprenticeship model for clinical training in the United States, a model both remarkably successful and directly descendant from Osler's innovations, will be under threat. PMID:17525535

  5. Community Cardiovascular Disease Risk From Cross-Sectional General Practice Clinical Data: A Spatial Analysis

    PubMed Central

    Gilmour, Bridget; McRae, Ian; Konings, Paul; Dawda, Paresh; Del Fante, Peter; van Weel, Chris

    2015-01-01

    Introduction Cardiovascular disease (CVD) continues to be a leading cause of illness and death among adults worldwide. The objective of this study was to calculate a CVD risk score from general practice (GP) clinical records and assess spatial variations of CVD risk in communities. Methods We used GP clinical data for 4,740 men and women aged 30 to 74 years with no history of CVD. A 10-year absolute CVD risk score was calculated based on the Framingham risk equation. The individual risk scores were aggregated within each Statistical Area Level One (SA1) to predict the level of CVD risk in that area. Finally, the pattern of CVD risk was visualized to highlight communities with high and low risk of CVD. Results The overall 10-year risk of CVD in our sample population was 14.6% (95% confidence interval [CI], 14.3%–14.9%). Of the 4,740 patients in our study, 26.7% were at high risk, 29.8% were at moderate risk, and 43.5% were at low risk for CVD over 10 years. The proportion of patients at high risk for CVD was significantly higher in the communities of low socioeconomic status. Conclusion This study illustrates methods to further explore prevalence, location, and correlates of CVD to identify communities of high levels of unmet need for cardiovascular care and to enable geographic targeting of effective interventions for enhancing early and timely detection and management of CVD in those communities. PMID:25719216

  6. 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

  7. [Osteoradionecrosis. I. Etiology, pathogenesis, clinical aspects and risk factors].

    PubMed

    Thiel, H J

    1989-01-01

    In curative therapy of mouth-cavity and oropharyngeal carcinomas the osteoradionecrosis has to be accepted as a calculated risk with an incidence of 4-35%. It is the question of a radio-caused bone death that comes about by progressive and irreversible morphological alterations at bones and at vessels: Loss of osteocytes, active osteoblasts and osteoclasts (hypocellularity), injury of normal bone metabolism, slackening of regeneration process, extreme susceptibility to infections of the devitalized bone, radio-induced obliterating endarteritis with hyalinization, thrombosis and fibrosing of vessels, obliteration of the lumen and gradual reduction of blood-supply at the level of tissue (hypovascularity and hypoxemia: Aseptic osteoradionecrosis, radio-osteonecrosis). If there is a secondary infection of dental, periodontal or traumatic origin additionally, the condition explodes as septic osteoradionecrosis with the symptoms and findings of radio-osteomyelitis. The osteoradionecrosis begins more frequently in the mandibula than in the maxilla. The cumulative incidence is 30% after 6, 60% after 12, and more than 80% after 24 months. The duration of osteoradionecrosis follows an exponential curve with constant probability of necrosis termination at any moment after necrosis event in which the monthly probability of necrosis healing is nearly 0.06. Risk factors for formation of an osteoradionecrosis are tumor neighbourhood to bones and teeth, tumor and mandibula dosis, tumor stage, irradiation technique, status of teeth as well as moment and carrying out of tooth extractions. Tumors in neighbourhood of mandibula have a fivefold higher risk, with 80 Gy irradiated patients a 2.9-fold and toothed patients a 2.6-fold, altogether high-risk patients have a 17.7-fold higher necrosis risk than low-risk patients. Promoting factors are caries, parodontosis, a periapical pathology, a trauma, irritation by artificial teeth, elective tooth extraction before irradiation, tooth

  8. Risk management and clinical governance for complex home-based health care.

    PubMed

    Lewis, Mary; Noyes, Jane

    2007-07-01

    Healthcare professionals have an obligation to enable children with complex needs to lead 'ordinary lives' at home but the views of professionals and family members often diverge in relation to the management of risks. Nurses are increasingly taking on the clinical responsibility for children with complex needs within a multidisciplinary, multi-agency team, yet have little training or experience in adapting risk management and clinical governance frameworks to home-based settings. Risk management frameworks for home-based care for children with complex health and social care needs are introduced in this article. Best practice guidance and resources for adapting risk management frameworks are presented to meet this identified gap in knowledge and experience. Children, young people and their parents have increasing expectations relating to the type and quality of home-based support they receive. Developing and applying clinical governance and risk management frameworks are part of improving outcomes for children with complex needs and their families. PMID:17694890

  9. 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

  10. Quality of Adolescent Mother-Infant Interactions and Clinical Determinations of Risk Status.

    ERIC Educational Resources Information Center

    Brophy-Herb, Holly E.; Honig, Alice Sterling

    1999-01-01

    Observed 37 pairs of low-income adolescent mothers and infants over a 6-month period to determine efficacy of clinical determinations of risk. Found that maternal-risk status was significantly associated with more sensitive parenting behaviors including responsiveness to infant cues and to infant distress, and social, emotional, and cognitive…

  11. 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…

  12. 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...

  13. 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...

  14. Phototherapy of psoriasis - clinical aspects and risk evaluation.

    PubMed

    Larkö, O

    1982-01-01

    The study gives information on the healing frequency and time to relapse in a day care centre for UVB, UVB plus dithranol, and PUVA treatment. Psoriasis treatment must be repeated for many years and a psoriasis patient must come to terms with the fact that during a substantial part of the rest of his life, he must use some type of treatment. This makes it important that the treatment is pleasant and easy to carry out. The combination of sauna and UVB in a day care centre, or treatment with home solaria fulfill these demands. In view of this background I think that UVB treatment of psoriasis could be the treatment of choice for many psoriasis patients. About 80 percent of the patients heal with this treatment. For the rest of the patients, addition of dithranol or a switch to PUVA has proven to be effective. Median time to healing was about 8 weeks with UVB and UVB + dithranol whereas 12 weeks was necessary to achieve healing among PUVA patients with a poor response to UVB given earlier. The remission times were 9, 12 and 25 weeks for UVB, UVB + dithranol and PUVA-treatment respectively. In Gothenburg, we give 35.000 UVB treatments annually. An important question is the potential hazards connected with the therapy as we know that UV radiation is carcinogenic. According to our studies, the median amount of UVB radiation actually received per year from therapy is of the same magnitude as during outdoor work or certain outdoor activities. If UVB treatment is expanded we can expect an increased incidence of skin cancer of squamous cell type among this type of psoriasis patient even if the retrospective study we made showed no increased risk among people extensively treated with UVB in the past. The risk for psoriasis patients on a life long UVB treatment will probably be of the same order of magnitude as for outdoor workers. In comparison with other every day risks, the risk of dying from a skin cancer seems to be negligible. Regular check-ups by a dermatologist can

  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. PMID:26233672

  16. Endocrine therapy for breast cancer prevention in high-risk women: clinical and economic considerations.

    PubMed

    Groom, Amy G; Younis, Tallal

    2016-04-01

    The global burden of breast cancer highlights the need for primary prevention strategies that demonstrate both favorable clinical benefit/risk profile and good value for money. Endocrine therapy with selective estrogen-receptor modulators (SERMs) or aromatase inhibitors (AIs) has been associated with a favorable clinical benefit/risk profile in the prevention of breast cancer in women at high risk of developing the disease. The available endocrine therapy strategies differ in terms of their relative reductions of breast cancer risk, potential side effects, and upfront drug acquisition costs, among others. This review highlights the clinical trials of SERMs and AIs for the primary prevention of breast cancer, and the cost-effectiveness /cost-utility studies that have examined their "value for money" in various health care jurisdictions. PMID:26923683

  17. Acute Hepatitis C Virus in an HIV Clinic: A Screening Strategy, Risk Factors, and Perception of Risk

    PubMed Central

    DeLong, A.K.; Maynard, M.A.; Chapman, S.; Gholam, P.; Blackard, J.T.; Rich, J.; Mayer, K.H.

    2011-01-01

    Abstract Acute hepatitis C virus (HCV) infection is being acquired undetected among HIV-infected individuals. A practical way to regularly screen HIV-infected patients for acute HCV irrespective of perceived risk or symptoms is needed. We piloted implementation of an acute HCV screening strategy using routine HIV clinical care schedules and the least costly blood tests, in a Rhode Island HIV care center. Study participants had ongoing HCV risk, completed questionnaires encompassing risk behaviors and perception of risk, and were screened with quarterly alanine aminotransferase (ALT). ALT rise triggered HCV RNA testing, with pooled rather than individual specimen HCV RNA testing for underinsured participants. Participants were primarily older, college-educated men who have sex with men (MSM) with history of sexually transmitted infection other than HIV. One of 58 participants developed acute HCV in 50 person–years of observation for an annual incidence of 2.0% per year (95% confidence interval [CI] 0.05–11.1%). The majority (54%) of MSM did not perceive that traumatic sexual and drug practices they were engaging in put them at risk for HCV. Unprotected sex often occurred under the influence of drugs or alcohol. Self-reported HCV risk and participation in several risk behaviors declined during the study. It was possible to collect frequent ALTs in a busy HIV clinic with 71% of total projected ALTs obtained and 88% of participants having at least one ALT during the 9-month follow-up period. All instances of ALT rise led to reflexive HCV RNA testing. Tracking quarterly ALT for elevation to systematically prompt HCV RNA testing before seroconversion is a promising approach to screen for acute HCV in a real-world HIV clinical setting. PMID:21859307

  18. 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

  19. An analysis of clinical risks in vaccine transportation.

    PubMed

    Fernando, Martina

    2004-10-01

    'Cold chain' transport is an integral part of a system of vaccine transportation that assures the potency of vaccines. If the temperature of vaccines is not kept between the ranges of 2 and 8 degrees C, this can lead to adverse effects especially for the recipients of first time immunization, as no protection is offered. This investigation has shown that there is considerable risk of vaccines being rendered impotent due to ad hoc collection of vaccines by healthcare professionals from pharmacy services, outside of the cold chain transport agreement with the vaccine supplier. This is because at present there are no guidelines for ad hoc collection of either vaccines or the approved cold chain equipment provided to transport the vaccine. The root cause analysis has shown that the general practice can manage this risk by making changes to its system for vaccine ordering, stock control and maintenance. A number of changes are proposed, including the appointment of a vaccine coordinator and the development of a protocol for ad hoc collection of vaccines from pharmacy. By focusing on improving the quality of the process, the practice can improve the care and safety of its immunization programme. PMID:15577715

  20. 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

  1. Ethics of Clinical Decision-Making for Older Drivers: Reporting Health-Related Driving Risk.

    PubMed

    Mazer, Barbara; Laliberté, Maude; Hunt, Matthew; Lemoignan, Josée; Gélinas, Isabelle; Vrkljan, Brenda; Naglie, Gary; Marshall, Shawn

    2016-06-01

    The number of older drivers will continue to increase as the population ages. Health care professionals have the responsibility of providing care and maintaining confidentiality for their patients while ensuring public safety. This article discusses the ethics of clinical decision-making pertaining to reporting health-related driving risk of older drivers to licensing authorities. Ethical considerations inherent in reporting driving risk, including autonomy, confidentiality, therapeutic relationships, and the uncertainty about determining individual driving safety and risk, are discussed. We also address the moral agency of reporting health-related driving risk and raise the question of whose responsibility it is to report. Issues of uncertainty surrounding clinical reasoning and concepts related to risk assessment are also discussed. Finally, we present two case studies to illustrate some of the issues and challenges faced by health care professionals as they seek to balance their responsibilities for their patients while ensuring road safety for all citizens. PMID:27117942

  2. 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

  3. 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

  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. Integrated risk assessment and feedback reporting for clinical decision making in a Medicare Risk plan.

    PubMed

    Schraeder, C; Britt, T; Shelton, P

    2000-10-01

    The challenge of tapping into the rich resource of population-based, aggregated data to inform and guide clinical processes remains one of the largely unrealized potentials of managed care. This article describes a multifaceted approach of using health-related data to support providers in clinical decision making as an adjunct to case management and primary care delivery. The goal is to provide data that can be used for clinical decision making that is population based, yet individualized for specific patient care situations. Information reporting holds great potential in the clinical care of patients because it can be used to identify persons who could benefit from early detection, intervention, or treatment. It has been suggested that one of the keys to success in managed Medicare is the timely use of information that is detailed, comprehensive, and real-time describing key parameters of clinical encounters. PMID:11067092

  6. 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

  7. Clinical factors predicting risk for aspiration and respiratory aspiration among patients with Stroke1

    PubMed Central

    Oliveira, Ana Railka de Souza; Costa, Alice Gabrielle de Sousa; Morais, Huana Carolina Cândido; Cavalcante, Tahissa Frota; Lopes, Marcos Venícios de Oliveira; de Araujo, Thelma Leite

    2015-01-01

    Objective: to investigate the association of risk factors with the Risk for aspiration nursing diagnosis and respiratory aspiration. Method: cross-sectional study assessing 105 patients with stroke. The instrument used to collect data addressing sociodemographic information, clinical variables and risk factors for Risk for aspiration. The clinical judgments of three expert RNs were used to establish the diagnosis. The relationship between variables and strength of association using Odds Ratio (OR) was verified both in regard to Risk for aspiration and respiratory aspiration. Results: risk for aspiration was present in 34.3% of the patients and aspiration in 30.5%. The following stood out among the risk factors: Dysphagia, Impaired or absent gag reflex, Neurological disorders, and Impaired physical mobility, all of which were statistically associated with Risk for aspiration. Note that patients who develop such a diagnosis were seven times more likely to develop respiratory aspiration. Conclusion: dysphagia, Impaired or absent gag reflex were the best predictors both for Risk for aspiration and respiratory aspiration. PMID:26039291

  8. 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

  9. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use.

    PubMed

    Kraus, V B; Blanco, F J; Englund, M; Karsdal, M A; Lohmander, L S

    2015-08-01

    Osteoarthritis (OA) is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for OA that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and (2) To stimulate establishment of ROAD (Risk of OA Development) and ROAP (Risk of OA Progression) tools analogous to the FRAX™ instrument for predicting risk of fracture in osteoporosis; and (3) To stimulate formulation of tools for identifying disease in its early preradiographic and/or molecular stages - REDI (Reliable Early Disease Identification). Consensus around more sensitive and specific diagnostic criteria for OA could spur development of disease modifying therapies for this entity that has proved so recalcitrant to date. We fully acknowledge that as we move forward, we expect to develop more sophisticated definitions, terminology and tools. PMID:25865392

  10. Clinical and Genetic Determinants of Cardiomyopathy Risk among Hematopoietic Cell Transplantation Survivors.

    PubMed

    Leger, Kasey J; Cushing-Haugen, Kara; Hansen, John A; Fan, Wenhong; Leisenring, Wendy M; Martin, Paul J; Zhao, Lue Ping; Chow, Eric J

    2016-06-01

    Cardiomyopathy has been recognized as a complication after hematopoietic cell transplantation (HCT). Using a nested case-cohort design, we examined the relationships between demographic, therapeutic, and selected cardiovascular disease risk factors among ≥1-year HCT survivors who developed cardiomyopathy before (n = 43) or after (n = 89) 1 year from HCT as compared to a randomly selected subcohort of survivors without cardiomyopathy (n = 444). Genomic data were available for 79 cases and 267 noncases. Clinical and genetic covariates were examined for association with the risk of early or late cardiomyopathy. Clinical risk factors associated with both early- and late-onset cardiomyopathy included anthracycline exposure ≥250 mg/m(2) and pre-existing hypertension. Among late-onset cardiomyopathy cases, the development of diabetes and ischemic heart disease further increased risk. We replicated several previously reported genetic associations among early-onset cardiomyopathy cases, including rs1786814 in CELF4, rs2232228 in HAS3, and rs17863783 in UGT1A6. None of these markers were associated with risk of late-onset cardiomyopathy. A combination of demographic, treatment, and clinical covariates predicted early-onset cardiomyopathy with reasonable accuracy (area under the curve [AUC], .76; 95% confidence interval [CI], .68 to .83), but prediction of late cardiomyopathy was poor (AUC, .59; 95% CI .53 to .67). The addition of genetic polymorphisms with marginal associations (odds ratios ≥1.3) did not enhance prediction for either early- or late-onset cardiomyopathy. Conventional cardiovascular risk factors influence the risk of both early- and late-onset cardiomyopathy in HCT survivors. Although certain genetic markers may influence the risk of early-onset disease, further work is required to validate previously reported findings and to determine how genetic information should be incorporated into clinically useful risk prediction models. PMID:26968791

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

    PubMed Central

    Rao, P. V.

    2015-01-01

    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

  12. Preventing the development of SLE: identifying risk factors and proposing pathways for clinical care.

    PubMed

    Choi, M Y; Barber, M R W; Barber, C E H; Clarke, A E; Fritzler, M J

    2016-07-01

    Although challenging, developing evidence-based approaches to an early and accurate diagnosis of systemic lupus erythematosus is a key approach to preventing disease and lupus-associated morbidity and mortality. Advances in our understanding of preclinical and incomplete lupus erythematosus have enabled the identification of risk factors that may predict disease and the development of potential strategies aimed at primary prevention. Emerging data support the notion that there is a temporal disease progression from initial asymptomatic autoimmunity (preclinical lupus) through early clinical features of the disease (incomplete lupus erythematosus) to finally becoming fully classifiable systemic lupus erythematosus (complete lupus erythematosus). Here, we review the demographic, clinical, biomarker as well as genetic and environmental features that are reported to increase the risk of disease progression. Based on these risk factors, we propose a clinical care pathway for patients with early disease. We envisage that such a pathway, through early identification of disease, may improve patient outcomes, while reducing health care costs. PMID:27252260

  13. 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. PMID:25576352

  14. 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

  15. 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.

  16. 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

  17. Belle Maudsley Lecture 2001. Risk management in orthodontics--making clinical practice safer.

    PubMed

    Nightingale, C

    2001-11-01

    Facing a civil claim for negligence or prosecution for breach of Health and Safety law is something that any sensible clinician wishes to avoid. This review discusses the main areas of risk in clinical practice and how such risks can be minimized when acting as a clinician and as an employer. Although orthodontic examples are used to highlight particular points, this paper is also relevant to general dental practice. PMID:11806186

  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. 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

  20. Barrett's esophagus and cancer risk: how research advances can impact clinical practice.

    PubMed

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

    2014-07-01

    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. 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

  2. Individual risk of cutaneous melanoma in New Zealand: developing a clinical prediction aid

    PubMed Central

    2014-01-01

    Background New Zealand and Australia have the highest melanoma incidence rates worldwide. In New Zealand, both the incidence and thickness have been increasing. Clinical decisions require accurate risk prediction but a simple list of genetic, phenotypic and behavioural risk factors is inadequate to estimate individual risk as the risk factors for melanoma have complex interactions. In order to offer tailored clinical management strategies, we developed a New Zealand prediction model to estimate individual 5-year absolute risk of melanoma. Methods A population-based case–control study (368 cases and 270 controls) of melanoma risk factors provided estimates of relative risks for fair-skinned New Zealanders aged 20–79 years. Model selection techniques and multivariate logistic regression were used to determine the important predictors. The relative risks for predictors were combined with baseline melanoma incidence rates and non-melanoma mortality rates to calculate individual probabilities of developing melanoma within 5 years. Results For women, the best model included skin colour, number of moles > =5 mm on the right arm, having a 1st degree relative with large moles, and a personal history of non-melanoma skin cancer (NMSC). The model correctly classified 68% of participants; the C-statistic was 0.74. For men, the best model included age, place of occupation up to age 18 years, number of moles > =5 mm on the right arm, birthplace, and a history of NMSC. The model correctly classified 67% of cases; the C-statistic was 0.71. Conclusions We have developed the first New Zealand risk prediction model that calculates individual absolute 5-year risk of melanoma. This model will aid physicians to identify individuals at high risk, allowing them to individually target surveillance and other management strategies, and thereby reduce the high melanoma burden in New Zealand. PMID:24884419

  3. 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.

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

    PubMed

    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

  5. The effects of HIV/AIDS intervention groups for high-risk women in urban clinics.

    PubMed Central

    Kelly, J A; Murphy, D A; Washington, C D; Wilson, T S; Koob, J J; Davis, D R; Ledezma, G; Davantes, B

    1994-01-01

    OBJECTIVE. This study reports the results of a behavior change intervention offered to women at high risk for human immunodeficiency virus (HIV) infection seen in an urban primary health care clinic. METHODS. Participants were 197 women randomly assigned to either an HIV/acquired immunodeficiency syndrome (AIDS) risk reduction group or a comparison group. Women in the HIV/AIDS intervention group attended five group sessions focusing on risk education; skills training in condom use, sexual assertiveness, problem solving, and risk trigger self-management; and peer support for change efforts. Women in the comparison group attended sessions on health topics unrelated to AIDS. RESULTS. At the 3-month follow-up, women in the HIV/AIDS intervention group had increased in sexual communication and negotiation skills. Unprotected sexual intercourse had declined significantly and condom use had increased from 26% to 56% of all intercourse occasions. Women in the comparison group showed no change. CONCLUSIONS. Socially disadvantaged women can be assisted in reducing their risk of contracting HIV infection. Risk reduction behavior change interventions should be offered routinely in primary health care clinics serving low-income and high-risk patients. PMID:7998630

  6. Risk Prediction for Prostate Cancer Recurrence Through Regularized Estimation with Simultaneous Adjustment for Nonlinear Clinical Effects*

    PubMed Central

    Long, Qi; Chung, Matthias; Moreno, Carlos S.; Johnson, Brent A.

    2011-01-01

    In biomedical studies, it is of substantial interest to develop risk prediction scores using high-dimensional data such as gene expression data for clinical endpoints that are subject to censoring. In the presence of well-established clinical risk factors, investigators often prefer a procedure that also adjusts for these clinical variables. While accelerated failure time (AFT) models are a useful tool for the analysis of censored outcome data, it assumes that covariate effects on the logarithm of time-to-event are linear, which is often unrealistic in practice. We propose to build risk prediction scores through regularized rank estimation in partly linear AFT models, where high-dimensional data such as gene expression data are modeled linearly and important clinical variables are modeled nonlinearly using penalized regression splines. We show through simulation studies that our model has better operating characteristics compared to several existing models. In particular, we show that there is a non-negligible effect on prediction as well as feature selection when nonlinear clinical effects are misspecified as linear. This work is motivated by a recent prostate cancer study, where investigators collected gene expression data along with established prognostic clinical variables and the primary endpoint is time to prostate cancer recurrence. We analyzed the prostate cancer data and evaluated prediction performance of several models based on the extended c statistic for censored data, showing that 1) the relationship between the clinical variable, prostate specific antigen, and the prostate cancer recurrence is likely nonlinear, i.e., the time to recurrence decreases as PSA increases and it starts to level off when PSA becomes greater than 11; 2) correct specification of this nonlinear effect improves performance in prediction and feature selection; and 3) addition of gene expression data does not seem to further improve the performance of the resultant risk

  7. 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

  8. Limited Clinical Utility of a Genetic Risk Score for the Prediction of Fracture Risk in Elderly Subjects

    PubMed Central

    Eriksson, Joel; Evans, Daniel S.; Nielson, Carrie M.; Shen, Jian; Srikanth, Priya; Hochberg, Marc; McWeeney, Shannon; Cawthon, Peggy M.; Wilmot, Beth; Zmuda, Joseph; Tranah, Greg; Mirel, Daniel B; Challa, Sashi; Mooney, Michael; Crenshaw, Andrew; Karlsson, Magnus; Mellström, Dan; Vandenput, Liesbeth; Orwoll, Eric; Ohlsson, Claes

    2014-01-01

    Context It is important to identify the patients at highest risk of fractures. A recent large-scale meta-analysis identified 63 autosomal SNPs associated with bone mineral density (BMD), of which 16 were also associated with fracture risk. Based on these findings two genetic risk scores (GRS63 and GRS16) were developed. Objective To determine the clinical usefulness of these GRS for the prediction of BMD, BMD change and fracture risk in elderly subjects. Design, Settings and Participants Two male (MrOS US, MrOS Sweden) and one female (SOF) large prospective cohorts of older subjects. Main Outcome Measures BMD, BMD change and radiographically and/or medically confirmed incident fractures (8,067 subjects, 2,185 incident non-vertebral or vertebral fractures). Results GRS63 was associated with BMD (≅3% of the variation explained), but not with BMD change. Both GRS63 and GRS16 were associated with fractures. After BMD-adjustment, the effect sizes for these associations were substantially reduced. Similar results were found using an unweighted GRS63 and an unweighted GRS16 compared to those found using the corresponding weighted risk scores. Only minor improvements in C-statistics (AUC) for fractures were seen when the GRSs were added to a base model (age, weight and height) and no significant improvements in C-statistics were seen when they were added to a model further adjusted for BMD. Net reclassification improvements with the addition of the GRSs to a base model were modest and substantially attenuated in BMD-adjusted models. Conclusions and Relevance GRS63 is associated with BMD, but not BMD change, suggesting that the genetic determinants of BMD differ from those of BMD change. When BMD is known, the clinical utility of the two GRSs for fracture prediction is limited in elderly subjects. PMID:25043339

  9. 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…

  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. 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. PMID:26133479

  13. A Virtual Clinic Improves Pneumococcal Vaccination for Asplenic Veterans at High Risk for Pneumococcal Disease

    PubMed Central

    Jump, Robin L.; Banks, Richard; Wilson, Brigid; Montpetite, Michelle M.; Carter, Rebecca; Phillips, Susan; Perez, Federico

    2015-01-01

    We developed a “virtual clinic” to improve pneumococcal vaccination among asplenic adults. Using an electronic medical record, we identified patients, assessed their vaccination status, entered orders, and notified patients and providers. Within 180 days, 38 of 76 patients (50%) received a pneumococcal vaccination. A virtual clinic may optimize vaccinations among high-risk patients. PMID:26668815

  14. 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. PMID:18684521

  15. 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

  16. 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

  17. 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. PMID:24280770

  18. 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

  19. 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

  20. A simulation framework for mapping risks in clinical processes: the case of in-patient transfers

    PubMed Central

    Ong, Mei-Sing; Westbrook, Johanna I; Magrabi, Farah; Coiera, Enrico; Wobcke, Wayne

    2011-01-01

    Objective To model how individual violations in routine clinical processes cumulatively contribute to the risk of adverse events in hospital using an agent-based simulation framework. Design An agent-based simulation was designed to model the cascade of common violations that contribute to the risk of adverse events in routine clinical processes. Clinicians and the information systems that support them were represented as a group of interacting agents using data from direct observations. The model was calibrated using data from 101 patient transfers observed in a hospital and results were validated for one of two scenarios (a misidentification scenario and an infection control scenario). Repeated simulations using the calibrated model were undertaken to create a distribution of possible process outcomes. The likelihood of end-of-chain risk is the main outcome measure, reported for each of the two scenarios. Results The simulations demonstrate end-of-chain risks of 8% and 24% for the misidentification and infection control scenarios, respectively. Over 95% of the simulations in both scenarios are unique, indicating that the in-patient transfer process diverges from prescribed work practices in a variety of ways. Conclusions The simulation allowed us to model the risk of adverse events in a clinical process, by generating the variety of possible work subject to violations, a novel prospective risk analysis method. The in-patient transfer process has a high proportion of unique trajectories, implying that risk mitigation may benefit from focusing on reducing complexity rather than augmenting the process with further rule-based protocols. PMID:21486883

  1. Impact of registration on clinical trials on infection risk in pediatric acute myeloid leukemia.

    PubMed

    Dix, David; Aplenc, Richard; Bowes, Lynette; Cellot, Sonia; Ethier, Marie-Chantal; Feusner, Jim; Gillmeister, Biljana; Johnston, Donna L; Lewis, Victor; Michon, Bruno; Mitchell, David; Portwine, Carol; Price, Victoria; Silva, Mariana; Stobart, Kent; Yanofsky, Rochelle; Zelcer, Shayna; Beyene, Joseph; Sung, Lillian

    2016-04-01

    Little is known about the impact of enrollment on therapeutic clinical trials on adverse event rates. Primary objective was to describe the impact of clinical trial registration on sterile site microbiologically documented infection for children with newly diagnosed acute myeloid leukemia (AML). We conducted a multicenter cohort study that included children aged ≤18 years with de novo AML. Primary outcome was microbiologically documented sterile site infection. Infection rates were compared between those registered and not registered on clinical trials. Five hundred seventy-four children with AML were included of which 198 (34.5%) were registered on a therapeutic clinical trial. Overall, 400 (69.7%) had at least one sterile site microbiologically documented infection. In multiple regression, registration on clinical trials was independently associated with a higher risk of microbiologically documented sterile site infection [adjusted odds ratio (OR) 1.24, 95% confidence interval (CI) 1.01-1.53; p = 0.040] and viridans group streptococcal infection (OR 1.46, 95% CI 1.08-1.98; p = 0.015). Registration on trials was not associated with Gram-negative or invasive fungal infections. Children with newly diagnosed AML enrolled on clinical trials have a higher risk of microbiologically documented sterile site infection. This information may impact on supportive care practices in pediatric AML. PMID:26515793

  2. 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

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

    PubMed Central

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

    2015-01-01

    Background 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. Objectives A theoretically driven approach was used to adapt RAP to fit implementation in outpatient methadone treatment clinics and pilot it with clinic patients. Methods 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. Results 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. Conclusions 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. PMID:26098970

  4. 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

  5. Clinical factors associated with venous thromboembolism risk in patients undergoing craniotomy.

    PubMed

    Kimmell, Kristopher T; Jahromi, Babak S

    2015-05-01

    OBJECT Patients undergoing craniotomy are at risk for developing venous thromboembolism (VTE). The safety of anticoagulation in these patients is not clear. The authors sought to identify risk factors predictive of VTE in patients undergoing craniotomy. METHODS The authors reviewed a national surgical quality database, the American College of Surgeons National Surgical Quality Improvement Program. Craniotomy patients were identified by current procedural terminology code. Clinical factors were analyzed to identify associations with VTE. RESULTS Four thousand eight hundred forty-four adult patients who underwent craniotomy were identified. The rate of VTE in the cohort was 3.5%, including pulmonary embolism in 1.4% and deep venous thrombosis in 2.6%. A number of factors were found to be statistically significant in multivariate binary logistic regression analysis, including craniotomy for tumor, transfer from acute care hospital, age ≥ 60 years, dependent functional status, tumor involving the CNS, sepsis, emergency surgery, surgery time ≥ 4 hours, postoperative urinary tract infection, postoperative pneumonia, on ventilator ≥ 48 hours postoperatively, and return to the operating room. Patients were assigned a score based on how many of these factors they had (minimum score 0, maximum score 12). Increasing score was predictive of increased VTE incidence, as well as risk of mortality, and time from surgery to discharge. CONCLUSIONS Patients undergoing craniotomy are at low risk of developing VTE, but this risk is increased by preoperative medical comorbidities and postoperative complications. The presence of more of these clinical factors is associated with progressively increased VTE risk; patients possessing a VTE Risk Score of ≥ 5 had a greater than 20-fold increased risk of VTE compared with patients with a VTE score of 0. PMID:25495743

  6. The Nurses' Global Assessment of Suicide Risk (NGASR): developing a tool for clinical practice.

    PubMed

    Cutcliffe, J R; Barker, P

    2004-08-01

    Contemporary and established literature indicates that people with mental health problems are at a higher risk of suicide than the general population. Because suicide is a multifaceted, complex phenomenon, risk assessment within the mental health care system requires a pluralistic, multidimensional and multiprofessional response. While assessment tools may provide useful guidance, especially guarding against complacency and over confidence, the fundamental basis of risk assessment must involve a thorough examination of the personal, interpersonal and social circumstances of each individual. Such thorough and rigorous assessments, the authors of this paper would add, require a degree of 'clinical judgement'. As a rule, inexperienced members of mental health care staff should not be charged with the responsibility of conducting suicide risk assessments without sound mentorship. However, with the right support and assessment tool, the novice practitioner might develop the kind of clinical judgement necessary for this critical task. Accordingly, this paper traces the development of the Nurses' Global Assessment of Suicide Risk (NGASR). It illustrates the practice development context out of which the need for the tool arose; it outlines the key evidence that underpins the construction of the tool and it is described. It is important to point out that as yet, no wide scale, quantitative validation of the tool has been conducted. Therefore, at this point, the tool should be treated with a degree of appropriate caution. Nevertheless, the preliminary attempts that have been made to 'validate' or 'rate' the tool in practice are included. While acknowledging that any risk assessment tool represents only one aspect of the necessarily broader assessment of risk, the NGASR appears to provide a useful template for the nursing assessment of suicide risk, especially for the novice. PMID:15255912

  7. Iron overload in non-transfusion-dependent thalassemia: association with genotype and clinical risk factors.

    PubMed

    Tantiworawit, Adisak; Charoenkwan, Pimlak; Hantrakool, Sasinee; Choeyprasert, Worawut; Sivasomboon, Chate; Sanguansermsri, Torpong

    2016-06-01

    In the present study, we sought to determine the prevalence of iron overload in patients with non-transfusion-dependent thalassemia (NTDT) and its association with genotype and other clinical risk factors, and to evaluate the correlation between serum ferritin (SF) and liver iron concentration (LIC). Myocardial and liver iron concentration was measured by MRI using a T2* gradient multi-echo sequence in NTDT patients, aged 10-50 years. Of 91 patients, 54 (59 %) had hepatic iron overload. None had cardiac iron overload. The clinical risk factors for hepatic iron overload were age >20 years (adjusted OR 30.2, 95 % CI 4.5-203, p < 0.001), hemoglobin level <7 g/dL (adjusted OR 6.3, 95 % CI 1.01-39.5, p = 0.049), and cumulative RBC transfusion >10 units (adjusted OR 53.6, 95 % CI 3.2-884, p = 0.005). Beta-thalassemia genotype was associated with higher risk of iron overload by univariate analysis, but the association was not significant when adjusted for other clinical factors. The correlation coefficient between SF and LIC was 0.60 (p < 0.001). In conclusion, the prevalence of hepatic iron overload is high in NTDT. Older age, lower hemoglobin level, and higher cumulative RBC transfusion are significant risk factors. SF and LIC show a significant positive correlation. PMID:27052211

  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. Knowledge of risk factors and the periodontal disease-systemic link in dental students' clinical decisions.

    PubMed

    Friesen, Lynn Roosa; Walker, Mary P; Kisling, Rebecca E; Liu, Ying; Williams, Karen B

    2014-09-01

    This study evaluated second-, third-, and fourth-year dental students' ability to identify systemic conditions associated with periodontal disease, risk factors most important for referral, and medications with an effect on the periodontium and their ability to apply this knowledge to make clinical decisions regarding treatment and referral of periodontal patients. A twenty-one question survey was administered at one U.S. dental school in the spring semester of 2012 to elicit the students' knowledge and confidence regarding clinical reasoning. The response rate was 86 percent. Periodontal risk factors were accurately selected by at least 50 percent of students in all three classes; these were poorly controlled diabetes, ≥6 mm pockets posteriorly, and lack of response to previous non-surgical therapy. Confidence in knowledge, knowledge of risk factors, and knowledge of medications with an effect on the periodontium improved with training and were predictive of better referral decision making. The greatest impact of training was seen on the students' ability to make correct decisions about referral and treatment for seven clinical scenarios. Although the study found a large increase in the students' abilities from the second through fourth years, the mean of 4.6 (out of 7) for the fourth-year students shows that, on average, those students missed correct treatment or referral on more than two of seven clinical cases. These results suggest that dental curricula should emphasize more critical decision making with respect to referral and treatment criteria in managing the periodontal patient. PMID:25179920

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Implementation of the High-Risk Alcoholism Relapse Scale in a Liver Transplant Clinic.

    PubMed

    Zhou, Min; Wagner, Laura M; Diflo, Thomas; Naegle, Madeline

    2015-01-01

    Because of the high prevalence of alcohol relapse after liver transplantation, transplant programs are challenged to evaluate alcoholism among liver transplant patients. Relapse after liver transplantation can have detrimental outcomes such as organ rejection, medical and social resource exhaustion, financial burden to the family and society, and negative public perception of organ transplantation. The purpose of this project was to improve post-liver transplant assessment for the risk of relapse to heavy alcohol use by implementing a protocol using the High-Risk Alcoholism Relapse (HRAR) scale (DiMartini et al., 2000; Yates et al., 1993). The project was conducted in an urban organ transplant center's outpatient post liver transplant clinic. Chart reviews assessed the process of patients identified as being at high risk and the transplant providers' completion of the HRAR scale. Eleven percent of patients assessed were identified as being at high risk for relapse of heavy alcohol use and 85% of providers used the HRAR scale in their clinic interviews. This project demonstrates that further refinements in techniques of predicting the risks of relapse are necessary, and nurses are in ideal positions to screen patients for alcohol use. PMID:26626033

  16. Genome-wide association study of clinically defined gout identifies multiple risk loci and its association with clinical subtypes

    PubMed Central

    Matsuo, Hirotaka; Yamamoto, Ken; Nakaoka, Hirofumi; Nakayama, Akiyoshi; Sakiyama, Masayuki; Chiba, Toshinori; Takahashi, Atsushi; Nakamura, Takahiro; Nakashima, Hiroshi; Takada, Yuzo; Danjoh, Inaho; Shimizu, Seiko; Abe, Junko; Kawamura, Yusuke; Terashige, Sho; Ogata, Hiraku; Tatsukawa, Seishiro; Yin, Guang; Okada, Rieko; Morita, Emi; Naito, Mariko; Tokumasu, Atsumi; Onoue, Hiroyuki; Iwaya, Keiichi; Ito, Toshimitsu; Takada, Tappei; Inoue, Katsuhisa; Kato, Yukio; Nakamura, Yukio; Sakurai, Yutaka; Suzuki, Hiroshi; Kanai, Yoshikatsu; Hosoya, Tatsuo; Hamajima, Nobuyuki; Inoue, Ituro; Kubo, Michiaki; Ichida, Kimiyoshi; Ooyama, Hiroshi; Shimizu, Toru; Shinomiya, Nariyoshi

    2016-01-01

    Objective Gout, caused by hyperuricaemia, is a multifactorial disease. Although genome-wide association studies (GWASs) of gout have been reported, they included self-reported gout cases in which clinical information was insufficient. Therefore, the relationship between genetic variation and clinical subtypes of gout remains unclear. Here, we first performed a GWAS of clinically defined gout cases only. Methods A GWAS was conducted with 945 patients with clinically defined gout and 1213 controls in a Japanese male population, followed by replication study of 1048 clinically defined cases and 1334 controls. Results Five gout susceptibility loci were identified at the genome-wide significance level (p<5.0×10−8), which contained well-known urate transporter genes (ABCG2 and SLC2A9) and additional genes: rs1260326 (p=1.9×10−12; OR=1.36) of GCKR (a gene for glucose and lipid metabolism), rs2188380 (p=1.6×10−23; OR=1.75) of MYL2-CUX2 (genes associated with cholesterol and diabetes mellitus) and rs4073582 (p=6.4×10−9; OR=1.66) of CNIH-2 (a gene for regulation of glutamate signalling). The latter two are identified as novel gout loci. Furthermore, among the identified single-nucleotide polymorphisms (SNPs), we demonstrated that the SNPs of ABCG2 and SLC2A9 were differentially associated with types of gout and clinical parameters underlying specific subtypes (renal underexcretion type and renal overload type). The effect of the risk allele of each SNP on clinical parameters showed significant linear relationships with the ratio of the case–control ORs for two distinct types of gout (r=0.96 [p=4.8×10−4] for urate clearance and r=0.96 [p=5.0×10−4] for urinary urate excretion). Conclusions Our findings provide clues to better understand the pathogenesis of gout and will be useful for development of companion diagnostics. PMID:25646370

  17. 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

  18. Prevalence of Clinical Anxiety, Clinical Depression and Associated Risk Factors in Chinese Young and Middle-Aged Patients with Osteonecrosis of the Femoral Head

    PubMed Central

    Gao, You-Shui; He, Hai-Yan; Jin, Dong-Xu; Zhang, Chang-Qing

    2015-01-01

    Objective To investigate the prevalence of clinical anxiety and clinical depression in Chinese young and mid-aged patients with osteonecrosis of the femoral head (ONFH) and to analyze their potential risk factors. Methods Two hundred and sixteen Chinese patients with ONFH were consecutively enrolled in this cross-sectional study from January 2010 to December 2010. The Zung self-rating anxiety scale (SAS) and the Zung self-rating depression scale (SDS) were used to assess the prevalence of clinical anxiety and clinical depression. An additional questionnaire containing seventeen items of potential risk factors was completed by all patients. Binary logistic regression analysis was employed to reveal potential risk factors of anxiety and depression. Results The prevalence of clinical anxiety and clinical depression was 20.4% and 21.8% in Chinese young and middle-aged patients with ONFH, respectively. Binary regression analysis showed that independent risk factors correlated with high incidence of clinical anxiety included involved femoral head (OR = 3.168, 95% CI: 1.496 - 6.708) and stages of ONFH (ORIV-V / II = 5.383, 95% CI: 1.664-17.416). Independent risk factors correlated with high incidence of depression included gender (OR = 2.853, 95% CI: 1.467-5.778), comorbid diseases (OR = 4.243, 95% CI: 1.940-9.278) and stages of the disease (OR IV-V/II = 16.963, 95% CI: 4.404-65.331). Conclusions Patients with bilateral ONFH are inclined to have clinical anxiety, while female patients and patients with comorbid diseases might tend to get clinical depression. Advanced stages of ONFH are independent risk factors for both clinical anxiety and clinical depression. PMID:25789850

  19. A Randomized Clinical Trial of Anticaries Therapies Targeted according to Risk Assessment (Caries Management by Risk Assessment)

    PubMed Central

    Featherstone, J.D.B.; White, J.M; Hoover, C.I.; Rapozo-Hilo, M.; Weintraub, J.A.; Wilson, R.S.; Zhan, L.; Gansky, S.A.

    2012-01-01

    This randomized parallel group clinical trial assessed whether combined antibacterial and fluoride therapy benefits the balance between caries pathological and protective factors. Eligible, enrolled adults (n = 231), with 1–7 baseline cavitated teeth, attending a dental school clinic were randomly assigned to a control or intervention group. Salivary mutans streptococci (MS), lactobacilli (LB), fluoride (F) level, and resulting caries risk status (low or high) assays were determined at baseline and every 6 months. After baseline, all cavitated teeth were restored. An examiner masked to group conducted caries exams at baseline and 2 years after completing restorations. The intervention group used fluoride dentifrice (1,100 ppm F as NaF), 0.12% chlorhexidine gluconate rinse based upon bacterial challenge (MS and LB), and 0.05% NaF rinse based upon salivary F. For the primary outcome, mean caries increment, no statistically significant difference was observed (24% difference between control and intervention groups, p = 0.101). However, the supplemental adjusted zero-inflated Poisson caries increment (change in DMFS) model showed the intervention group had a statistically significantly 24% lower mean than the control group (p = 0.020). Overall, caries risk reduced significantly in intervention versus control over 2 years (baseline adjusted generalized linear mixed models odds ratio, aOR = 3.45; 95% CI: 1.67, 7.13). Change in MS bacterial challenge differed significantly between groups (aOR = 6.70; 95% CI: 2.96, 15.13) but not for LB or F. Targeted antibacterial and fluoride therapy based on salivary microbial and fluoride levels favorably altered the balance between pathological and protective caries risk factors. PMID:22472515

  20. A randomized clinical trial of anticaries therapies targeted according to risk assessment (caries management by risk assessment).

    PubMed

    Featherstone, J D B; White, J M; Hoover, C I; Rapozo-Hilo, M; Weintraub, J A; Wilson, R S; Zhan, L; Gansky, S A

    2012-01-01

    This randomized parallel group clinical trial assessed whether combined antibacterial and fluoride therapy benefits the balance between caries pathological and protective factors. Eligible, enrolled adults (n = 231), with 1-7 baseline cavitated teeth, attending a dental school clinic were randomly assigned to a control or intervention group. Salivary mutans streptococci (MS), lactobacilli (LB), fluoride (F) level, and resulting caries risk status (low or high) assays were determined at baseline and every 6 months. After baseline, all cavitated teeth were restored. An examiner masked to group conducted caries exams at baseline and 2 years after completing restorations. The intervention group used fluoride dentifrice (1,100 ppm F as NaF), 0.12% chlorhexidine gluconate rinse based upon bacterial challenge (MS and LB), and 0.05% NaF rinse based upon salivary F. For the primary outcome, mean caries increment, no statistically significant difference was observed (24% difference between control and intervention groups, p = 0.101). However, the supplemental adjusted zero-inflated Poisson caries increment (change in DMFS) model showed the intervention group had a statistically significantly 24% lower mean than the control group (p = 0.020). Overall, caries risk reduced significantly in intervention versus control over 2 years (baseline adjusted generalized linear mixed models odds ratio, aOR = 3.45; 95% CI: 1.67, 7.13). Change in MS bacterial challenge differed significantly between groups (aOR = 6.70; 95% CI: 2.96, 15.13) but not for LB or F. Targeted antibacterial and fluoride therapy based on salivary microbial and fluoride levels favorably altered the balance between pathological and protective caries risk factors. PMID:22472515

  1. 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

  2. Fusion of clinical and stochastic finite element data for hip fracture risk prediction.

    PubMed

    Jiang, Peng; Missoum, Samy; Chen, Zhao

    2015-11-26

    Hip fracture affects more than 250,000 people in the US and 1.6 million worldwide per year. With an aging population, the development of reliable fracture risk models is therefore of prime importance. Due to the complexity of the hip fracture phenomenon, the use of clinical data only, as it is done traditionally, might not be sufficient to ensure an accurate and robust hip fracture prediction model. In order to increase the predictive ability of the risk model, the authors propose to supplement the clinical data with computational data from finite element models. The fusion of the two types of data is performed using deterministic and stochastic computational data. In the latter case, uncertainties in loading and material properties of the femur are accounted for and propagated through the finite element model. The predictive capability of a support vector machine (SVM) risk model constructed by combining clinical and finite element data was assessed using a Women׳s Health Initiative (WHI) dataset. The dataset includes common factors such as age and BMD as well as geometric factors obtained from DXA imaging. The fusion of computational and clinical data systematically leads to an increase in predictive ability of the SVM risk model as measured by the AUC metric. It is concluded that the largest gains in AUC are obtained by the stochastic approach. This gain decreases as the dimensionality of the problem increases: a 5.3% AUC improvement was achieved for a 9 dimensional problem involving geometric factors and weight while a 1.3% increase was obtained for a 20 dimensional case including geometric and conventional factors. PMID:26482733

  3. Assessment of Clinical Risk Management System in Hospitals: An Approach for Quality Improvement

    PubMed Central

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

    2015-01-01

    Background: Clinical risks have created major problems in healthcare system such as serious adverse effects on patient safety and enhancing the financial burden for the healthcare. Thus, clinical risk management (CRM) system has been introduced for improving the quality and safety of services to health care. The aim of this study was to assess the status of CRM in the hospitals. Methods: A cross-sectional study was conducted on 200 nursing staff from three teaching hospitals affiliated with the Kerman University of Medical Sciences in southeast of Iran. Data were collected from the participants using questionnaire and observational checklist in quality improvement offices and selected wards. The data were analyzed using SPSS version 20. Results: Almost, 57% of persons participated in at least one of training sessions on CRM. The status of CRM system was rated from weak to moderate (2.93±0.72- 3.18±0.66). Among the six domains of CRM system, the highest mean belonged to domain the monitoring of analysis, evaluation and risk control (3.18±0.72); the lowest mean belonged to domain the staff’s knowledge, recognition and understanding of CRM (2.93±0.66). There were no integrated electronic systems for recording and analyzing clinical risks and incidents in the hospitals. Conclusion: Attempts have been made to establish CRM through improvement quality approach such as clinical governance and accreditation, but not enough, however, health care should move toward quality improvement and safe practice through the effective integration of CRM in organizational process. PMID:26156927

  4. 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

  5. Understanding and De-risking the Dependencies between Operator and Manufacturer of Clinical IT.

    PubMed

    Despotou, George; Arvanitis, Theodoros N; White, Sean

    2015-01-01

    Health IT, in addition to benefits can also have unintended consequences both in terms of operational and business risks. Understanding the dependencies between operator and manufacturer as well as issues that need to be addressed during procurement is essential to increase confidence in the operation of health IT. The paper provides the context, and a number of issues health IT operators such as clinical organisations, need to investigate during acquisition of health IT. PMID:26152991

  6. A clinical risk stratification tool for predicting treatment resistance in major depressive disorder

    PubMed Central

    Perlis, Roy

    2013-01-01

    Background Early identification of depressed individuals at high risk for treatment-resistance could be helpful in selecting optimal setting and intensity of care. At present, validated tools to facilitate this risk stratification are rarely used in psychiatric practice. Methods Data were drawn from the first two treatment levels of a multicenter antidepressant effectiveness study in major depressive disorder, the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) cohort. This cohort was divided into training, testing, and validation subsets. Only clinical or sociodemographic variables available by, or readily amenable to, self-report were considered. Multivariate models were developed to discriminate individuals reaching remission with a first or second pharmacologic treatment trial from those not reaching remission despite two trials. Results A logistic regression model achieved an area under the receiver operating characteristic curve (AUC) exceeding 0.71 in training, testing and validation cohorts, and maintained good calibration across cohorts. Performance of three alternative models using machine learning approaches–a naïve Bayes classifier and a support vector machine, and a random forest model – was less consistent. Similar performance was observed between more and less severe depression, males and females, and primary versus specialty care sites. A web-based calculator was developed which implements this tool and provides graphical estimates of risk. Conclusion Risk for treatment-resistance among outpatients with major depressive disorder can be estimated using a simple model incorporating baseline sociodemographic and clinical features. Future studies should examine the performance of this model in other clinical populations and its utility in treatment selection or clinical trial design. Registration Sequential Treatment Alternatives to Relieve Depression (STAR*D); NCT00021528; www.star-d.org PMID:23380715

  7. 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.

  8. 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

  9. Nurse-led risk assessment/management clinics reduce predicted cardiac morbidity and mortality in claudicants.

    PubMed

    Hatfield, Josephine; Gulati, Sumit; Abdul Rahman, Morhisham N A; Coughlin, Patrick A; Chetter, Ian C

    2008-12-01

    Nurse-led assessment/management of risk factors is effective in many chronic medical conditions. We aimed to evaluate whether this finding was true for patients with intermittent claudication and to analyze its impact on patient-reported quality of life and predicted mortality due to coronary heart disease. We prospectively studied a series of 78 patients (51 men; median age, 65 years [IQR: 56-74 years]), diagnosed with intermittent claudication and referred to a nurse-led risk assessment/management clinic (NLC) from a consultant-led vascular surgical clinic. The NLC used clinical care pathways to manage antiplatelet medication, smoking cessation, hyperlipidemia, hypertension, and diabetes and to provide exercise advice. All patients were reassessed at a 3 months. Medication compliance, smoking status, fasting lipid profiles, blood pressure, and HbA1c were recorded. Disease-specific quality of life was assessed using King's College VascuQoL and predicted cardiac morbidity and mortality were calculated using the PROCAM and Framingham risk scores. We found that NLC enrollment produced an antiplatelet and a statin compliance of 100%, a smoking cessation rate of 17% (9 patients) and significant improvements in total cholesterol (median, 5.2-4.5 mmol/l), LDL (median, 3.1-2.5 mmol/l) and triglyceride (median, 1.7-1.4 mmol/l) levels. Significant disease-specific quality of life improvements and significant reduction in both the PROCAM (14% to 10%) and Framingham (14% to 11%) coronary risk scores were observed. Providing care at NLCs for claudicants is effective in assessing and managing risk factors, improves disease-specific quality of life and reduces predicted morbidity and mortality due to coronary heart disease. PMID:19022170

  10. 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

  11. Effectiveness of Physical Exercise to Reduce Cardiovascular Risk Factors in Youths: A Randomized Clinical Trial

    PubMed Central

    Cesa, Claudia Ciceri; Barbiero, Sandra Mari; Petkowicz, Rosemary de Oliveira; Martins, Carla Correa; Marques, Renata das Virgens; Andreolla, Allana Abreu Martins; Pellanda, Lucia Campos

    2015-01-01

    Background The aim of the current study was to test the effectiveness of a physical activity and exercise-based program in a clinical context to reduce cardiovascular risk factors in children and adolescents. Methods A randomized clinical trial was conducted in a pediatric preventive outpatient clinic. Intervention was 14 weeks of exercise for the intervention group or general health advice for the control group. The primary and the secondary outcomes were reduction of cardiovascular risk factors and the feasibility and the effectiveness of clinical advice plan to practice physical exercises at home. Results A total of 134 children were screened; 26 met eligibility criteria. Of these, 10 were allocated in the exercise intervention group and nine were included in the control group until the end of the intervention. Those patients who discontinued the intervention had the lowest scores of z-BMI (P = 0.033) and subscapular skin fold (P = 0.048). After 14 weeks of intervention, no statistical differences were found between the groups. High-density lipoprotein cholesterol (HDL-C) was higher in the exercise group, with a mild tendency to be significant (P = 0.066). Patients who adhere to treatment had diastolic blood pressure decreased from baseline to the end of the follow-up period in the control group (P = 0.013). Regardless of this result, the other comparisons within the group were not statistically different between T0 and T14. Conclusion A low-cost physical activity advice intervention presented many barriers for implementation in routine clinical care, limiting its feasibility and evaluation of effectiveness to reduce cardiovascular risk factors. PMID:25780484

  12. 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

  13. Profiles of Risk Among HIV-Infected Youth in Clinic Settings.

    PubMed

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

    2015-05-01

    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

  14. 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

  15. 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

  16. Predicting reoffense in pedophilic child molesters by clinical diagnoses and risk assessment.

    PubMed

    Eher, Reinhard; Olver, Mark E; Heurix, Isabelle; Schilling, Frank; Rettenberger, Martin

    2015-12-01

    A Diagnostic and Statistical Manual of Mental Disorders (DSM)-based diagnosis of pedophilia has so far failed to predict sexual reoffense in convicted child molesters, probably because of its broad and unspecific conceptualization. In this study, therefore, we investigated the prognostic value of the subtype exclusive pedophilia and a series of customary risk assessment instruments (SSPI, Static-99, Stable-2007, VRS:SO) and the PCL-R in a sample of prison released pedophilic sexual offenders. First, we examined the convergent validity of risk assessment instruments (N = 261). Then, we calculated the predictive accuracy of the measures and diagnosis for sexual recidivism by ROC analyses and subsequent Cox regression (N = 189). Also, predictive values with more clinical immediacy were calculated (sensitivity, specificity, PPV and NPV). The VRS:SO, the SSPI, and the Static-99 significantly predicted sexual recidivism, as did a diagnosis of exclusive pedophilia. Also, the VRS:SO predicted sexual reoffense significantly better than the Stable-2007, the Static-99/Stable-2007 combined score, and the PCL-R. When used combined, only the VRS:SO and a diagnosis of exclusive pedophilia added incremental validity to each other. Our findings support that the clinical diagnosis of an exclusive pedophilia based on DSM criteria and VRS:SO defined risk factors can reliably discriminate higher from lower risk offenders, even within the select subgroup of pedophilic child molesters. PMID:26146817

  17. 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

  18. RD3 loss dictates high-risk aggressive neuroblastoma and poor clinical outcomes

    PubMed Central

    Aravindan, Sheeja; Natarajan, Mohan; Azadi, Seifollah; Herman, Terence S.; Aravindan, Natarajan

    2015-01-01

    Clinical outcomes for high-risk neuroblastoma patients remains poor, with only 40–50% 5-Year overall survival (OS) and <10% long-term survival. The ongoing acquisition of genetic/molecular rearrangements in undifferentiated neural crest cells may endorse neuroblastoma progression. This study recognized the loss of Retinal Degeneration protein 3, RD3 in aggressive neuroblastoma, and identified its influence in better clinical outcomes and defined its novel metastasis suppressor function. The results showed ubiquitous expression of RD3 in healthy tissues, complete-loss and significant TNM-stage association of RD3 in clinical samples. RD3-loss was intrinsically associated with reduced OS, abridged relapse-free survival, aggressive stage etc., in neuroblastoma patient cohorts. RD3 was transcriptionally and translationally regulated in metastatic site-derived aggressive (MSDAC) cells (regardless of CSC status) ex vivo and in tumor manifolds from metastatic sites in reproducible aggressive disease models in vivo. Re-expressing RD3 in MSDACs reverted their metastatic potential both in vitro and in vivo. Conversely muting RD3 in neuroblastoma cells not only heightened invasion/migration but also dictated aggressive disease with metastasis. These results demonstrate the loss of RD3 in high-risk neuroblastoma, its novel, thus-far unrecognized metastasis suppressor function and further imply that RD3-loss may directly relate to tumor aggressiveness and poor clinical outcomes. PMID:26375249

  19. Radiologically Isolated Syndrome: 5-Year Risk for an Initial Clinical Event

    PubMed Central

    Okuda, Darin T.; Siva, Aksel; Kantarci, Orhun; Inglese, Matilde; Katz, Ilana; Tutuncu, Melih; Keegan, B. Mark; Donlon, Stacy; Hua, Le H.; Vidal-Jordana, Angela; Montalban, Xavier; Rovira, Alex; Tintoré, Mar; Amato, Maria Pia; Brochet, Bruno; de Seze, Jérôme; Brassat, David; Vermersch, Patrick; De Stefano, Nicola

    2014-01-01

    Objective To report the 5-year risk and to identify risk factors for the development of a seminal acute or progressive clinical event in a multi-national cohort of asymptomatic subjects meeting 2009 RIS Criteria. Methods Retrospectively identified RIS subjects from 22 databases within 5 countries were evaluated. Time to the first clinical event related to demyelination (acute or 12-month progression of neurological deficits) was compared across different groups by univariate and multivariate analyses utilizing a Cox regression model. Results Data were available in 451 RIS subjects (F: 354 (78.5%)). The mean age at from the time of the first brain MRI revealing anomalies suggestive of MS was 37.2 years (y) (median: 37.1 y, range: 11–74 y) with mean clinical follow-up time of 4.4 y (median: 2.8 y, range: 0.01–21.1 y). Clinical events were identified in 34% (standard error = 3%) of individuals within a 5-year period from the first brain MRI study. Of those who developed symptoms, 9.6% fulfilled criteria for primary progressive MS. In the multivariate model, age [hazard ratio (HR): 0.98 (95% CI: 0.96–0.99); p = 0.03], sex (male) [HR: 1.93 (1.24–2.99); p = 0.004], and lesions within the cervical or thoracic spinal cord [HR: 3.08 (2.06–4.62); p = <0.001] were identified as significant predictors for the development of a first clinical event. Interpretation These data provide supportive evidence that a meaningful number of RIS subjects evolve to a first clinical symptom. An age <37 y, male sex, and spinal cord involvement appear to be the most important independent predictors of symptom onset. PMID:24598783

  20. Comparing the probability of stroke by the Framingham risk score in hypertensive Korean patients visiting private clinics and tertiary hospitals

    PubMed Central

    2010-01-01

    Background The purpose of this study was to investigate the pattern of distribution of risk factors for stroke and the 10-year probability of stroke by the Framingham risk score in hypertensive patients visiting private clinics vs. tertiary hospitals. Methods A total of 2,490 hypertensive patients who attended 61 private clinics (1088 patients) and 37 tertiary hospitals (1402 patients) were enrolled. The risk factors for stroke were evaluated using a series of laboratory tests and physical examinations, and the 10-year probability of stroke was determined by applying the Framingham stroke risk equation. Results The proportion of patients who had uncontrolled hypertension despite the use of antihypertensive agents was 49% (66 and 36% of patients cared for at private clinics and tertiary hospitals, respectively; p < 0.001). The average 10-year probability of stroke by the Framingham risk score in hypertensive patients was 21% (approximately 2.2 times higher than of the risk of stroke in the Korean Cancer Prevention Study [KCPS] cohort) and was higher in patients attending tertiary hospitals compared to private clinics (16 and 24% of patients attending private clinics and tertiary hospitals, respectively; p < 0.001). Conclusions Since the 10-year probability of stroke by the Framingham risk score in hypertensive patients attending tertiary hospitals was higher than the risk for patients attending private clinics. We suggest that the more aggressive interventions are needed to prevent and early detect an attack of stroke in hypertensive patients attending tertiary hospitals. PMID:20822544

  1. 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

  2. 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

  3. Comparison of Clinical and Automated Breast Density Measurements: Implications for Risk Prediction and Supplemental Screening.

    PubMed

    Brandt, Kathleen R; Scott, Christopher G; Ma, Lin; Mahmoudzadeh, Amir P; Jensen, Matthew R; Whaley, Dana H; Wu, Fang Fang; Malkov, Serghei; Hruska, Carrie B; Norman, Aaron D; Heine, John; Shepherd, John; Pankratz, V Shane; Kerlikowske, Karla; Vachon, Celine M

    2016-06-01

    Purpose To compare the classification of breast density with two automated methods, Volpara (version 1.5.0; Matakina Technology, Wellington, New Zealand) and Quantra (version 2.0; Hologic, Bedford, Mass), with clinical Breast Imaging Reporting and Data System (BI-RADS) density classifications and to examine associations of these measures with breast cancer risk. Materials and Methods In this study, 1911 patients with breast cancer and 4170 control subjects matched for age, race, examination date, and mammography machine were evaluated. Participants underwent mammography at Mayo Clinic or one of four sites within the San Francisco Mammography Registry between 2006 and 2012 and provided informed consent or a waiver for research, in compliance with HIPAA regulations and institutional review board approval. Digital mammograms were retrieved a mean of 2.1 years (range, 6 months to 6 years) before cancer diagnosis, with the corresponding clinical BI-RADS density classifications, and Volpara and Quantra density estimates were generated. Agreement was assessed with weighted κ statistics among control subjects. Breast cancer associations were evaluated with conditional logistic regression, adjusted for age and body mass index. Odds ratios, C statistics, and 95% confidence intervals (CIs) were estimated. Results Agreement between clinical BI-RADS density classifications and Volpara and Quantra BI-RADS estimates was moderate, with κ values of 0.57 (95% CI: 0.55, 0.59) and 0.46 (95% CI: 0.44, 0.47), respectively. Differences of up to 14% in dense tissue classification were found, with Volpara classifying 51% of women as having dense breasts, Quantra classifying 37%, and clinical BI-RADS assessment used to classify 43%. Clinical and automated measures showed similar breast cancer associations; odds ratios for extremely dense breasts versus scattered fibroglandular densities were 1.8 (95% CI: 1.5, 2.2), 1.9 (95% CI: 1.5, 2.5), and 2.3 (95% CI: 1.9, 2.8) for Volpara, Quantra

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Risk Factors for Pancreatic Neuroendocrine Tumors (PNETs): A Clinic-Based Case-Control study

    PubMed Central

    Halfdanarson, Thorvardur R.; Bamlet, William R.; McWilliams, Robert R; Hobday, Timothy J.; Burch, Patrick A.; Rabe, Kari G.; Petersen, Gloria M.

    2014-01-01

    Objectives Pancreatic neuroendocrine tumors (PNETs) are uncommon, and little is known about their risk factors and association with other cancers. We evaluated whether risk factors known to be associated with pancreatic adenocarcinoma are also associated with PNETs: smoking, alcohol use, family history of PNET and other cancers, and personal history of diabetes as potential risk factors. Methods Patients with PNETs seen at Mayo Clinic Rochester between 2000 and 2011 were compared to controls seen for a general medical evaluation. Patients and controls completed the same questionnaires. After excluding insulinoma and high-grade PNETs, 355 cases were evaluated, and 309 were matched to 602 controls (2:1) on age, sex, and region of residence. Results Personal smoking history was not associated with PNETs. Alcohol use was less common among cases (54% vs. 67%, p<0.001). Cases were more likely to report a family member with sarcoma (p=0.02), PNET (p=0.02), gall bladder cancer (p=0.02), ovarian cancer (p=0.04) and gastric cancer (p=0.01). There was no association with other cancers in family members. Diabetes was more commonly reported by cases than controls (19% vs. 11%, p<0.001). Conclusions With the exception of diabetes, risk factors that are associated with pancreatic adenocarcinoma are not risk factors for PNETs. PMID:25291526

  10. 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

  11. Familial and sporadic porphyria cutanea tarda: clinical and biochemical features and risk factors in 152 patients.

    PubMed

    Muñoz-Santos, Carlos; Guilabert, Antonio; Moreno, Nemesio; To-Figueras, Jordi; Badenas, Celia; Darwich, Esteve; Herrero, Carmen

    2010-03-01

    Porphyria cutanea tarda is the most frequent porphyria and occurs in both sporadic and familial forms. We conducted the current study in a series of 152 consecutive patients with porphyria cutanea tarda attending the Porphyria Unit of the Hospital Clinic of Barcelona, Spain, to update the clinical manifestations of the disease and to study the sex differences, the proportion of familial forms, and the role of different risk factors in this population. Patients were classified as familial and sporadic cases according to erythrocyte uroporphyrinogen-decarboxylase activity and uroporphyrinogen-decarboxylase genotyping. In our cohort, skin fragility and blisters on the hands were the most frequent clinical manifestations. Women more frequently had facial hypertrichosis (84.8%; p = 0.004), affected areas other than the hands and face (33.3%; p = 0.008), and pruritus (27.3%; p = 0.041) compared with men. Of our patients, 11.8% did not present the typical clinical onset of the disease, with facial hypertrichosis and hyperpigmentation the more frequent complaints in these cases. Analysis of risk factors showed a high prevalence of hepatitis C virus infection (65.8%) and alcohol abuse (59.9%), both being more frequent in men (p < 0.001). Hepatitis C virus infection was the only risk factor that showed differences between the sporadic and familial forms in the logistic regression model (odds ratio, 0.05; 95% confidence interval, 0.006-0.46). In conclusion, atypical forms of presentation of porphyria cutanea tarda should be considered in order to prevent delayed diagnosis. We note the sustained role of hepatitis C virus infection in the precipitation of sporadic porphyria cutanea tarda. Therefore, in countries with a high prevalence of hepatitis C virus infection, the absence of such infection in a patient with porphyria cutanea tarda may suggest a possible familial case. PMID:20517178

  12. Evaluation of Berlin Questionnaire Validity for Sleep Apnea Risk in Sleep Clinic Populations

    PubMed Central

    Khaledi-Paveh, Behnam; Khazaie, Habibolah; Nasouri, Marzie; Ghadami, Mohammad Rasoul; Tahmasian, Masoud

    2016-01-01

    Introduction: The Berlin questionnaire (BQ) is a common tool to screen for Obstructive Sleep Apnea (OSA) in the general population, but its application in the clinical sleep setting is still challenging. The aim of this study was to determine the specificity and sensitivity of the BQ compared to the apnea-hypopnea index obtained from polysomnography recordings obtained from a sleep clinic in Iran. Methods: We recruited 100 patients who were referred to the Sleep Disorders Research Center of Kermanshah University of Medical Sciences for the evaluation of suspected sleep-disorder breathing difficulties. Patients completed a Persian version of BQ and underwent one night of PSG. For each patient, Apnea-Hypopnea Index (AHI) was calculated to assess the diagnosis and severity of OSA. Severity of OSA was categorized as mild when AHI was between 5 and 15, moderate when it was between 15 and 30, and severe when it was more than 30. Results: BQ results categorized 65% of our patients as high risk and 35% as low risk for OSA. The sensitivity and the specificity of BQ for OSA diagnosis with AHI>5 were 77.3% and 23.1%, respectively. Positive predictive value was 68.0% and negative predictive value was 22.0%. Moreover, the area under curve was 0.53 (95% CI: 0.49 – 0.67, P=0.38). Discussion: Our findings suggested that BQ, despite its advantages in the general population, is not a precise tool to determine the risk of sleep apnea in the clinical setting, particularly in the sleep clinic population. PMID:27303598

  13. Novel Clinical Scale for Evaluating Pre-Operative Risk of Cerebral Herniation from Traumatic Epidural Hematoma.

    PubMed

    Lin, Hong; Wang, Wen-Hao; Hu, Lian-Shui; Li, Jun; Luo, Fei; Lin, Jun-Ming; Huang, Wei; Zhang, Ming-Sheng; Zhang, Yuan; Hu, Kang; Zheng, Jian-Xian

    2016-06-01

    Secondary massive cerebral infarction (MCI) is the predominant prognostic factor for cerebral herniation from epidural hematoma (EDH) and determines the need for decompressive craniectomy. In this study, we tested the clinical feasibility and reliability of a novel pre-operative risk scoring system, the EDH-MCI scale, to guide surgical decision making. It is comprised of six risk factors, including hematoma location and volume, duration and extent of cerebral herniation, Glasgow Coma Scale score, and presence of preoperative shock, with a total score ranging from 0 to 18 points. Application of the EDH-MCI scale to guide surgical modalities for initial hematoma evacuation surgery for 65 patients (prospective cohort, 2012.02-2014.01) showed a significant improvement in the accuracy of the selected modality (95.38% vs. 77.95%; p = 0.002) relative to the results for an independent set of 126 patients (retrospective cohort, 2007.01-2012.01) for whom surgical modalities were decided empirically. Results suggested that simple hematoma evacuation craniotomy was sufficient for patients with low risk scores (≤9 points), whereas decompressive craniectomy in combination with duraplasty were necessary only for those with high risk scores (≥13 points). In patients with borderline risk scores (10-12 points), those having unstable vital signs, coexistence of severe secondary brainstem injury, and unresponsive dilated pupils after emergent burr hole hematoma drainage had a significantly increased incidence of post-traumatic MCI and necessity of radical surgical treatments. In conclusion, the novel pre-operative risk EDH-MCI evaluation scale has a satisfactory predictive and discriminative performance for patients who are at risk for the development of secondary MCI and therefore require decompressive craniectomy. PMID:25393339

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. The clinical course of cirrhosis: The importance of multistate models and competing risks analysis.

    PubMed

    Jepsen, Peter; Vilstrup, Hendrik; Andersen, Per Kragh

    2015-07-01

    Multistate models are models of disease progression that, for a patient group, define multiple outcome events, each of which may affect the time to develop another outcome event. Multistate models are highly relevant for studies of patients with cirrhosis; both the classical perception of cirrhosis as either compensated or decompensated and the recent, more complex models of cirrhosis progression are multistate models. Therefore, researchers who conduct clinical studies of patients with cirrhosis must realize that most of their research questions assume a multistate disease model. Failure to do so can result in severely biased results and bad clinical decisions. The analyses that can be used to study disease progression in a multistate disease model may be called competing risks analysis, named after the competing risks disease model, which is the simplest multistate disease model. In this review article, we introduce multistate disease models and competing risks analysis and explain why the standard armamentarium of Kaplan-Meier survival estimates and Cox regression sometimes gives bad answers to good questions. We also use real data to answer typical research questions about the course of cirrhosis and illustrate biases resulting from inadequate methods. Finally, we suggest statistical software packages that are helpful and accessible to the clinician-researcher. PMID:25376655

  20. 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

  1. Clinical high risk and first episode schizophrenia: Auditory event-related potentials

    PubMed Central

    del Re, Elisabetta C.; Spencer, Kevin M.; Oribe, Naoya; Mesholam-Gately, Raquelle I.; Goldstein, Jill; Shenton, Martha E.; Petryshen, Tracey; Seidman, Larry J.; McCarley, Robert W.; Niznikiewicz, Margaret A.

    2014-01-01

    The clinical high risk (CHR) period is a phase denoting a risk for overt psychosis during which subacute symptoms often appear, and cognitive functions may deteriorate. To compare biological indices during this phase with those during first episode schizophrenia, we cross-sectionally examined sex- and age-matched clinical high risk (CHR, n=21), first episode schizophrenia patients (FESZ, n=20) and matched healthy controls (HC, n=25) on oddball and novelty paradigms and assessed the N100, P200, P3a and P3b as indices of perceptual, attentional and working memory processes. To our knowledge, this is the only such comparison using all of these event-related potentials (ERPs) in two paradigms. We hypothesized that the ERPs would differentiate between the three groups and allow prediction of a diagnostic group. The majority of ERPs were significantly affected in CHR and FESZ compared with controls, with similar effect sizes. Nonetheless, in logistic regression, only the P3a and N100 distinguished CHR and FESZ from healthy controls, suggesting that ERPs not associated with an overt task might be more sensitive to prediction of group membership. PMID:25557063

  2. Clinical high risk and first episode schizophrenia: auditory event-related potentials.

    PubMed

    del Re, Elisabetta C; Spencer, Kevin M; Oribe, Naoya; Mesholam-Gately, Raquelle I; Goldstein, Jill; Shenton, Martha E; Petryshen, Tracey; Seidman, Larry J; McCarley, Robert W; Niznikiewicz, Margaret A

    2015-02-28

    The clinical high risk (CHR) period is a phase denoting a risk for overt psychosis during which subacute symptoms often appear, and cognitive functions may deteriorate. To compare biological indices during this phase with those during first episode schizophrenia, we cross-sectionally examined sex- and age-matched clinical high risk (CHR, n=21), first episode schizophrenia patients (FESZ, n=20) and matched healthy controls (HC, n=25) on oddball and novelty paradigms and assessed the N100, P200, P3a and P3b as indices of perceptual, attentional and working memory processes. To our knowledge, this is the only such comparison using all of these event-related potentials (ERPs) in two paradigms. We hypothesized that the ERPs would differentiate between the three groups and allow prediction of a diagnostic group. The majority of ERPs were significantly affected in CHR and FESZ compared with controls, with similar effect sizes. Nonetheless, in logistic regression, only the P3a and N100 distinguished CHR and FESZ from healthy controls, suggesting that ERPs not associated with an overt task might be more sensitive to prediction of group membership. PMID:25557063

  3. 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

  4. 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. PMID:26305514

  5. 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. PMID:24489669

  6. 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

  7. 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

  8. Pancreatic cancer early detection: Expanding higher-risk group with clinical and metabolomics parameters

    PubMed Central

    Urayama, Shiro

    2015-01-01

    Pancreatic ductal adenocarcinoma (PDAC) is the fourth and fifth leading cause of cancer death for each gender in developed countries. With lack of effective treatment and screening scheme available for the general population, the mortality rate is expected to increase over the next several decades in contrast to the other major malignancies such as lung, breast, prostate and colorectal cancers. Endoscopic ultrasound, with its highest level of detection capacity of smaller pancreatic lesions, is the commonly employed and preferred clinical imaging-based PDAC detection method. Various molecular biomarkers have been investigated for characterization of the disease, but none are shown to be useful or validated for clinical utilization for early detection. As seen from studies of a small subset of familial or genetically high-risk PDAC groups, the higher yield and utility of imaging-based screening methods are demonstrated for these groups. Multiple recent studies on the unique cancer metabolism including PDAC, demonstrate the potential for utility of the metabolites as the discriminant markers for this disease. In order to generate an early PDAC detection screening strategy available for a wider population, we propose to expand the population of higher risk PDAC group with combination clinical and metabolomics parameters. PMID:25684935

  9. 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

  10. Clinical risk of stigma and discrimination of mental illnesses: Need for objective assessment and quantification.

    PubMed

    Shrivastava, Amresh; Bureau, Yves; Rewari, Nitika; Johnston, Megan

    2013-04-01

    Stigma and discrimination continue to be a reality in the lives of people suffering from mental illness, particularly schizophrenia, and prove to be one of the greatest barriers to regaining a normal lifestyle and health. Research advances have defined stigma and assessed its implications and have even examined intervention strategies for dealing with stigma. We are of the opinion that stigma is a potential clinical risk factor. It delays treatment seeking, worsens course and outcome, reduces compliance, and increases the risk of relapse; causing further disability, discrimination, and isolation even in persons who have accessed mental health services. The delay in treatment due to stigma causes potential complications like suicide, violence, harm to others, and deterioration in capacity to look after one's physical health. These are preventable clinical complications. In order to deal with the impact of stigma on an individual basis, it needs to be (i) assessed during routine clinical examination, (ii) assessed for quantification in order to obtain measurable objective deliverables, and (iii) examined if treatment can reduce stigma and its impact on individuals. New and innovative anti-stigma programs are required that are clinically driven in order to see the change in life of an individual by removing potential risks. The basic requirement for dealing with an individual's stigma perception/experience is its proper assessment for origin and impact in both a qualitative and quantitative manner. We further argue that quantification would allow for regular assessment and offer more effective intervention for patients. It will also be helpful in identifying modifiable social factors to enhance quality of care planning for management in hospitals and communities. The objective of quantification is to facilitate developing an approach to bring the assessment of stigma into clinical work and formulating customized strategies to deal with stigma at the patient level. It

  11. Identifying Adult Dengue Patients at Low Risk for Clinically Significant Bleeding

    PubMed Central

    Wong, Joshua G. X.; Thein, Tun Linn; Leo, Yee-Sin; Pang, Junxiong; Lye, David C.

    2016-01-01

    Background Clinically significant bleeding is important for subsequent optimal case management in dengue patients, but most studies have focused on dengue severity as an outcome. Our study objective was to identify differences in admission parameters between patients who developed clinically significant bleeding and those that did not. We sought to develop a model for discriminating between these patients. Methods We conducted a retrospective study of 4,383 adults aged >18 years who were hospitalized with dengue infection at Tan Tock Seng Hospital, Singapore from 2005 to 2008. Patients were divided into those with clinically significant bleeding (n = 188), and those without (n = 4,195). Demographic, clinical, and laboratory variables on admission were compared between groups to determine factors associated with clinically significant bleeding during hospitalization. Results On admission, female gender (p<0.001); temperature >38°C (p<0.001); nausea/vomiting (p = 0.009) and abdominal pain/tenderness (p = 0.005); lower systolic blood pressure (p<0.001); higher pulse rate (p<0.001); increased absolute neutrophil count (ANC; p<0.001); reduced absolute lymphocyte count (ALC; p<0.001), haematocrit percentage (p<0.001) and platelet count (p = 0.04), and increased prothrombin time (p = 0.003) were significantly associated with clinically significant bleeding on univariate analysis. Multivariate analysis showed that independent variables in the final model were female gender (aOR 2.85; 95% CI: 1.9–4.33); temperature >38°C (aOR 1.81; 95% CI: 1.27–2.61), nausea/vomiting (aOR 1.39; 95% CI: 0.94–2.12), ANC (aOR 1.3; 95% CI: 1.15–1.46), ALC (aOR 0.4; 95% CI: 0.25–0.64), hematocrit percentage (aOR 0.96; 95% CI: 0.92–1.002) and platelet count (aOR 0.993; 95% CI: 0.988–0.998). At the cutoff of -3.919, the model achieved an AUC of 0.758 (sensitivity:0.87, specificity: 0.38, PPV: 0.06, NPV: 0.98). Conclusion Clinical risk factors associated with clinically significant

  12. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... subjects. Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out...

  13. [Clinical usefulness of Nephral ST dialyzers in hemodialyzed patients with increased risk of bleeding].

    PubMed

    Kopeć, Jerzy; Sułowicz, Władysław

    2010-01-01

    Hemodialyzed patients with increased risk of bleeding can be dialyzed according to a method of limited anticoagulant use including saline flush technique, regional citrate anticoagulation, regional heparinization or use of membranes with low thrombogenic properties. Methods that limit anticoagulation use are not completely effective, increase work load for the dialysis team and create a risk of complications. The aim of the study was to evaluate the clinical usefulness of Nephral ST dialyzers with poli-acrylonitrile membranes treated with polyethylenimine binding heparin in hemodialyzed patients with increased risk of bleeding. In 12 patients with increased bleeding risk, 121 hemodialyzed sessions were performed utilizing Nephral ST dialyzers. Heparin was not administered during the procedure. Degree of clotting of the dialyzer and the venous drip chamber was evaluated using a 4-degree visual scale. Platelet count, partial activation time of thromboplastine (APTT), thrombin time (TT), antithrombin III, as well as d-dimer concentrations were measured before dialysis and after 15, 120 and 240 minutes of procedure. No complications of massive clotting necessitating premature termination of dialysis was noted. In most sessions trace or small clotting was observed in the dialyzers and drip chambers. No significant differences in platelet count and AT III levels were measured. Increased TT and APTT after 15 minutes of dialysis were observed, which was probably due to release of small amounts of dialyzer membrane heparin. After 120 and 240 minutes these values returned to normal ranges. These observations along with increased d-dimers after 240 minutes suggested an increased risk of clotting during evaluated sessions. Application of Nephral ST dialyzers permits for heparin-free dialysis procedure in patients with increased risk of bleeding. PMID:20557006

  14. Failure to disclose HIV risk among gay and bisexual men attending sexually transmitted disease clinics.

    PubMed

    Doll, L S; Harrison, J S; Frey, R L; McKirnan, D; Bartholow, B N; Douglas, J M; Joy, D; Bolan, G; Doetsch, J

    1994-01-01

    We analyzed data from a multisite study of 1,063 gay or bisexual men attending sexually transmitted disease clinics to evaluate factors predicting failure to disclose human immunodeficiency virus (HIV) risk behaviors to clinic staff and the extent of such failure. We compared data from a brief screening assessment on unprotected anal and oral sex with data on the same behaviors from a subsequent detailed interview. We also compared behavioral data from screening and the interview with data on diagnoses of rectal gonorrhea abstracted from medical charts. Of 523 men reporting unprotected anal sex at interview, 29% failed to report this behavior at screening. Men failing to disclose unprotected anal sex were also less likely to disclose engaging in unprotected oral sex. Among men reporting no unprotected anal sex, either at screening or interview, 1.6% were diagnosed with rectal gonorrhea. Logistic regression analyses comparing men who did and did not disclose at screening having engaged in unprotected anal sex showed that men who failed to disclose reported greater involvement in gay organizations, greater perceived peer support for condoms, fewer episodes of unprotected anal sex in the last four months, and lower rates of substance abuse treatment. Our data suggest that men who failed to disclose may have lower risk levels, and may be more integrated into the gay community. Brief interviews, as opposed to detailed ones, also may underestimate incidence of unsafe sex. Where feasible, HIV risk assessment and counseling and laboratory screening should be routinely provided to all clinic attendees, regardless of self-reports. PMID:7917436

  15. 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

  16. 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

  17. 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.

  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. Risk assessment of feline tooth resorption: a Portuguese clinical case control study.

    PubMed

    Mestrinho, Lisa A; Runhau, Jens; Bragança, Mauro; Niza, Maria M R E

    2013-01-01

    Tooth resorption (TR) is one of the most common dental diseases in cats. Determination of risk factors has not yet been fully assessed and, to the best knowledge of the authors, this disease has never been studied in Portuguese cats. The objective of this case-control study was to determine type and distribution of TR lesions, evaluate risk factors, and establish relationships between variables in this disease. The study included data from 71 cats admitted for general anesthesia for various reasons. The cats were randomly selected. The inclusion criteria were availability of clinical history and owner permission. Cats with known oral disease were not excluded from the study. All cats received ultrasonic scaling and polishing of the teeth, a thorough oral examination, and full-mouth radiographs. A strong statistical relation was found between age and TR. The age group of 10 to 15-years showed an increased risk of 6.56 times for TR occurrence compared with the group 0 to 4-years of age. Presence of gingivitis in all index levels was related to an increased risk for TR. No relation was found between age or gingivitis index and lesion type. Mandibular third premolar and molar teeth were most commonly affected by TR, especially for type 1 lesions. Canine teeth were statistically more likely to have type 2 lesions. The trend for the canine teeth to be more affected with type 2 lesions needs further verification. PMID:24006716

  20. 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

  1. 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

  2. Clinical Usefulness of Novel Serum and Imaging Biomarkers in Risk Stratification of Patients with Stable Angina

    PubMed Central

    Ikonomidis, Ignatios; Tsantes, Argirios

    2014-01-01

    Inflammatory mediators appear to be the most intriguing yet confusing subject, regarding the management of patients with acute coronary syndromes (ACS). The current inflammatory concept of atherosclerotic coronary artery disease (CAD) led many investigators to concentrate on systemic markers of inflammation, as well as imaging techniques, which may be helpful in risk stratification and prognosis assessment for cardiovascular events. In this review, we try to depict many of the recently studied markers regarding stable angina (SA), their clinical usefulness, and possible future applications in the field. PMID:25045198

  3. 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

  4. 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. PMID:25689542

  5. Quality assurance study of caries risk assessment performance by clinical faculty members in a school of dentistry.

    PubMed

    Rechmann, Peter; Featherstone, John D B

    2014-09-01

    The goal of this quality assurance study was to explore the decision making of clinical faculty members at the University of California, San Francisco School of Dentistry predoctoral dental clinic in terms of caries risk level assignment using the caries risk assessment (CRA) as part of the Caries Management by Risk Assessment (CAMBRA) concept. This research was done in part to determine if additional training and calibration were needed for these faculty members. The study tested the reliability and reproducibility of the caries risk levels assigned by different clinical teachers who completed CRA forms for simulated patients. In the first step, five clinical teachers assigned caries risk levels for thirteen simulated patients. Six months later, the same five plus an additional nine faculty members assigned caries risk levels to the same thirteen simulated and nine additional cases. While the intra-examiner reliability with weighted kappa strength of agreement was very high, the inter-examiner agreements with a gold standard were on average only moderate. In total, 20 percent of the presented high caries risk cases were underestimated at caries levels too low, even when obvious caries disease indicators were present. This study suggests that more consistent training and calibration of clinical faculty members as well as students are needed. PMID:25179930

  6. 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...

  7. 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,…

  8. 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

  9. 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. PMID:25941147

  10. 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

  11. 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

  12. A risk management approach for imaging biomarker-driven clinical trials in oncology.

    PubMed

    Liu, Yan; deSouza, Nandita M; Shankar, Lalitha K; Kauczor, Hans-Ulrich; Trattnig, Siegfried; Collette, Sandra; Chiti, Arturo

    2015-12-01

    Imaging has steadily evolved in clinical cancer research as a result of improved conventional imaging methods and the innovation of new functional and molecular imaging techniques. Despite this evolution, the design and data quality derived from imaging within clinical trials are not ideal and gaps exist with paucity of optimised methods, constraints of trial operational support, and scarce resources. Difficulties associated with integrating imaging biomarkers into trials have been neglected compared with inclusion of tissue and blood biomarkers, largely because of inherent challenges in the complexity of imaging technologies, safety issues related to new imaging contrast media, standardisation of image acquisition across multivendor platforms, and various postprocessing options available with advanced software. Ignorance of these pitfalls directly affects the quality of the imaging read-out, leading to trial failure, particularly when imaging is a primary endpoint. Therefore, we propose a practical risk-based framework and recommendations for trials driven by imaging biomarkers, which allow identification of risks at trial initiation to better allocate resources and prioritise key tasks. PMID:26678215

  13. 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. PMID:21735994

  14. Incidence, risk stratification, antibiogram of pathogens isolated and clinical outcome of ventilator associated pneumonia

    PubMed Central

    Gupta, Alok; Agrawal, Avinash; Mehrotra, Sanjay; Singh, Abhishek; Malik, Shruti; Khanna, Arjun

    2011-01-01

    Background: The initial empirical therapy of Ventilator Associated Pneumonia (VAP) modified based on the knowledge of local microbiological data is associated with decreased morbidity and mortality. The objective was to find the incidence and risk factors associated with VAP, the implicated pathogens and their susceptibility pattern as well as to assess the final clinical outcome in VAP. Materials and Methods: This was a prospective cohort study of 107 patients taken on ventilatory support for two or more days and those not suffering from pneumonia prior were to be taken on ventilator. The study was done over a period of one year. VAP was diagnosed using clinical pulmonary infection score of >6. The mortality, incidence of VAP, frequency of different pathogens isolated, their antibiotic sensitivity pattern, duration of mechanical ventilation and duration of hospital stay were assessed. Statistical Analysis: Univariate analysis, χ2 test and paired t-test. Results: The incidence of VAP was 28.04%. Mortality in VAP group was 46.67%, while in the non-VAP group was 27.28%. High APACHE II score was associated with a high mortality rate as well as increased incidence of VAP. The most common organisms isolated from endotracheal aspirate of patients who developed VAP were Pseudomonas aeruginosa, Methicillin-resistant Staphylococcus aureus (MRSA), Klebsiella pneumoniae and Acinetobacter baumannii. Most strains of Pseudomonas (55.56%) were resistant to commonly used beta-lactam antibiotics known to be effective against Pseudomonas. All strains of Staphylococcus aureus were MRSA and most isolates of K. pneumoniae (85.71%) were extended-spectrum beta-lactamase producing. About 50% isolates of Acinetobacter were resistant to carbapenems. Mortality was highest for infections caused by A. baumannii (83.33%) and K. pneumoniae (71.42%). Conclusions: APACHE II score can be used to stratify the risk of development of VAP and overall risk of mortality. Drug-resistant strains of

  15. Clinical features and risk factor analysis for lower extremity deep venous thrombosis in Chinese neurosurgical patients

    PubMed Central

    Guo, Fuyou; Shashikiran, Tagilapalli; Chen, Xi; Yang, Lei; Liu, Xianzhi; Song, Laijun

    2015-01-01

    Background: Deep venous thrombosis (DVT) contributes significantly to the morbidity and mortality of neurosurgical patients; however, no data regarding lower extremity DVT in postoperative Chinese neurosurgical patients have been reported. Materials and Methods: From January 2012 to December 2013, 196 patients without preoperative DVT who underwent neurosurgical operations were evaluated by color Doppler ultrasonography and D-dimer level measurements on the 3rd, 7th, and 14th days after surgery. Follow-up clinical data were recorded to determine the incidence of lower extremity DVT in postoperative neurosurgical patients and to analyze related clinical features. First, a single factor analysis, Chi-square test, was used to select statistically significant factors. Then, a multivariate analysis, binary logistic regression analysis, was used to determine risk factors for lower extremity DVT in postoperative neurosurgical patients. Results: Lower extremity DVT occurred in 61 patients, and the incidence of DVT was 31.1% in the enrolled Chinese neurosurgical patients. The common symptoms of DVT were limb swelling and lower extremity pain as well as increased soft tissue tension. The common sites of venous involvement were the calf muscle and peroneal and posterior tibial veins. The single factor analysis showed statistically significant differences in DVT risk factors, including age, hypertension, smoking status, operation time, a bedridden or paralyzed state, the presence of a tumor, postoperative dehydration, and glucocorticoid treatment, between the two groups (P < 0.05). The binary logistic regression analysis showed that an age greater than 50 years, hypertension, a bedridden or paralyzed state, the presence of a tumor, and postoperative dehydration were risk factors for lower extremity DVT in postoperative neurosurgical patients. Conclusions: Lower extremity DVT was a common complication following craniotomy in the enrolled Chinese neurosurgical patients. Multiple

  16. 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

  17. 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

  18. 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

  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

    2015-01-01

    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

  20. Neural Dysfunction in Cognitive Control Circuits in Persons at Clinical High-Risk for Psychosis.

    PubMed

    Colibazzi, Tiziano; Horga, Guillermo; Wang, Zhishun; Huo, Yuankai; Corcoran, Cheryl; Klahr, Kristin; Brucato, Gary; Girgis, Ragy; Gill, Kelly; Abi-Dargham, Anissa; Peterson, Bradley S

    2016-04-01

    Cognitive control, a set of functions that develop throughout adolescence, is important in the pathogenesis of psychotic disorders. Whether cognitive control has a role in conferring vulnerability for the development of psychotic illness is still unknown. The aim of this study was to investigate the neural systems supporting cognitive control in individuals deemed to be potentially prodromal for psychotic illness. We recruited 56 participants at clinical high-risk (CHR) for psychosis based on the Structured Interview for Psychosis-Risk Syndromes (SIPS) and 49 healthy controls. Twelve of the CHR participants eventually developed psychosis. We compared functional magnetic resonance imaging (fMRI) BOLD signal during the performance of the Simon task. We tested for differences between CHR individuals and controls in conflict-related functional activity. In the CHR group when compared with controls, we detected smaller conflict-related activations in several cortical areas, including the Dorsolateral Prefrontal Cortex (DLPFC). Furthermore, conflict-related activations in the DLPFC of those CHR individuals who ultimately developed psychosis (CHR converters) were smaller than in non-converters (CHR non-converters). Higher levels of conflict-related activation were associated with better social and role outcome. Risk for psychosis was associated at the neural level with reduced conflict-related brain activity. This neural phenotype appears correlated within the DLPFC with the development of psychosis and with functional outcome. PMID:26354046

  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. 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

  3. 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

  4. Incident atrial fibrillation hazard in hypertensive population: a risk function from and for clinical practice.

    PubMed

    Alves-Cabratosa, Lia; García-Gil, Maria; Comas-Cufí, Marc; Ponjoan, Anna; Martí, Ruth; Parramon, Dídac; Blanch, Jordi; Ramos, Rafel

    2015-06-01

    Determining the risk of atrial fibrillation within the hypertensive population without ischemic vascular disease would aid in decision making on preventive approaches. Accordingly, we aimed to estimate the risk of incident atrial fibrillation in this population. We conducted an historical cohort study between July 1, 2006, and December 31, 2011, using anonymized longitudinal patient information from primary care and hospital discharge records contained in the System for the Development of Research in Primary Care database. We included 255 440 hypertensive patients, aged ≥55 years at the time of study entry. Individuals with previous atrial fibrillation, ischemic heart disease, stroke, and peripheral artery disease were excluded. To build the incident atrial fibrillation risk function, a derivation and a validation cohort were defined, representing 60% and 40% of the entire database, respectively, and a Cox proportional hazards model was fitted. Atrial fibrillation incidence was 7.24 per 1000 person-years (95% confidence interval, 7.08-7.40). The final model included age, weight, total cholesterol, heart failure, valvular heart disease, and antihypertensive treatment. Its concordance index (standard error) was 0.769 (0.004) and 0.768 (0.005) in the derivation and validation datasets, respectively. This research provides a tool, built with variables from daily clinical practice, that can be readily used in the primary care setting to predict atrial fibrillation incidence in the hypertensive population without ischemic vascular disease. The tool may help tailor individualized diagnostic and preventive care decisions. PMID:25847950

  5. Clinical phenotype and risk of levodopa-induced dyskinesia in Parkinson's disease.

    PubMed

    Nicoletti, Alessandra; Mostile, Giovanni; Nicoletti, Giuseppe; Arabia, Gennarina; Iliceto, Giovanni; Lamberti, Paolo; Marconi, Roberto; Morgante, Letterio; Barone, Paolo; Quattrone, Aldo; Zappia, Mario

    2016-05-01

    It is unclear whether patients with different clinical phenotypes of Parkinson's disease (PD) differ in their risk of developing levodopa-induced dyskinesia. We evaluated the possible association between clinical phenotypes and risk of levodopa-induced dyskinesia in PD patients using a case-control design. The FRAGAMP study is a large Italian multicenter study. Patients affected by PD diagnosed according to the Gelb's criteria were enrolled and underwent a face-to-face interview. Clinical scales were used to evaluate motor and cognitive impairment. Presence of dyskinesia was assessed by the item 32 of the UPDRS section IV. On the basis of the most prominent motor symptoms at onset PD, patients were classified as tremor-dominant, akinetic-rigid, or mixed type. 485 PD patients (292 men; mean age 65.6 ± 9.8) were enrolled in the study of whom 128 (26.4 %) presented levodopa-induced dyskinesia. Of the 485 patients, 311 (64.1 %) were classified as tremor-dominant, 104 (21.4 %) as Akinetic-Rigid and 70 (14.4 %) as mixed type. Multivariate logistic regression analysis showed a significant negative association between tremor-dominant phenotype and levodopa-induced dyskinesia (adjusted OR 0.48; 95 % CI 0.23-1.00; p value 0.05). When analysis was stratified by age at onset a stronger negative association was found among the late onset (>50 years) PD patients (OR 0.28; 95 % CI 0.11-0.70; p value 0.007) while no association was found among patients with an early onset. Our findings support the hypothesis that the occurrence of resting tremor as an initial manifestation of PD may predict a lower probability of developing levodopa-induced dyskinesia. PMID:26964541

  6. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation

    PubMed Central

    Hijazi, Ziad; Lindbäck, Johan; Alexander, John H.; Hanna, Michael; Held, Claes; Hylek, Elaine M.; Lopes, Renato D.; Oldgren, Jonas; Siegbahn, Agneta; Stewart, Ralph A.H.; White, Harvey D.; Granger, Christopher B.; Wallentin, Lars

    2016-01-01

    Aims Atrial fibrillation (AF) is associated with an increased risk of stroke, which is currently estimated by clinical characteristics. The cardiac biomarkers N-terminal fragment B-type natriuretic peptide (NT-proBNP) and cardiac troponin high-sensitivity (cTn-hs) are independently associated with risk of stroke in AF. Our objective was to develop and validate a new biomarker-based risk score to improve prognostication of stroke in patients with AF. Methods and results A new risk score was developed and internally validated in 14 701 patients with AF and biomarkers levels determined at baseline, median follow-up of 1.9 years. Biomarkers and clinical variables significantly contributing to predicting stroke or systemic embolism were assessed by Cox-regression and each variable obtained a weight proportional to the model coefficients. External validation was performed in 1400 patients with AF, median follow-up of 3.4 years. The most important predictors were prior stroke/transient ischaemic attack, NT-proBNP, cTn-hs, and age, which were included in the ABC (Age, Biomarkers, Clinical history) stroke risk score. The ABC-stroke score was well calibrated and yielded higher c-indices than the widely used CHA2DS2-VASc score in both the derivation cohort (0.68 vs. 0.62, P < 0.001) and the external validation cohort (0.66 vs. 0.58, P < 0.001). Moreover, the ABC-stroke score consistently provided higher c-indices in several important subgroups. Conclusion A novel biomarker-based risk score for predicting stroke in AF was successfully developed and internally validated in a large cohort of patients with AF and further externally validated in an independent AF cohort. The ABC-stroke score performed better than the presently used clinically based risk score and may provide improved decision support in AF. ClinicalTrials. gov identifier NCT00412984, NCT00799903. PMID:26920728

  7. Ulcerative colitis patients in clinical remission demonstrate correlations between fecal immunochemical test results, mucosal healing, and risk of relapse

    PubMed Central

    Nakarai, Asuka; Kato, Jun; Hiraoka, Sakiko; Takashima, Shiho; Takei, Daisuke; Inokuchi, Toshihiro; Sugihara, Yuusaku; Takahara, Masahiro; Harada, Keita; Okada, Hiroyuki

    2016-01-01

    AIM: To assess the risk of relapse in ulcerative colitis (UC) patients in clinical remission using mucosal status and fecal immunochemical test (FIT) results. METHODS: The clinical outcomes of 194 UC patients in clinical remission who underwent colonoscopy were based on evaluations of Mayo endoscopic subscores (MESs) and FIT results. RESULTS: Patients with an MES of 0 (n = 94, 48%) showed a ten-fold lower risk of relapse than those with an MES of 1-3 (n = 100, 52%) (HR = 0.10, 95%CI: 0.05-0.19). A negative FIT result (fecal hemoglobin concentrations ≤ 100 ng/mL) was predictive of patients with an MES of 0, with a sensitivity of 0.94 and a specific of 0.76. Moreover, patients with a negative FIT score had a six-fold lower risk of clinical relapse than those with a positive score (HR = 0.17, 95%CI: 0.10-0.28). Inclusion of the distinguishing parameter, sustaining clinical remission > 12 mo, resulted in an even stronger correlation between negative FIT results and an MES of 0 with respect to the risk of clinical relapse (HR = 0.11, 95%CI: 0.04-0.23). CONCLUSION: Negative FIT results one year or more after remission induction correlate with complete mucosal healing (MES 0) and better prognosis. Performing FIT one year after remission induction may be useful for evaluating relapse risk. PMID:27275100

  8. 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

  9. Analysis of risk factor and clinical characteristics of angiodysplasia presenting as upper gastrointestinal bleeding

    PubMed Central

    Kim, Dae Bum; Chung, Woo Chul; Lee, Seok Jong; Sung, Hea Jung; Woo, Seokyung; Kim, Hyo Suk; Jeong, Yeon Oh; Lee, Hyewon; Kim, Yeon-Ji

    2016-01-01

    Background/Aims: Angiodysplasia is important in the differential diagnosis of upper gastrointestinal bleeding (UGIB), but the clinical features and outcomes associated with UGIB from angiodysplasia have not been characterized. We aimed to analyze the clinical characteristics and outcomes of angiodysplasia presented as UGIB. Methods: Between January 2004 and December 2013, a consecutive series of patients admitted with UGIB were retrospectively analyzed. Thirty-five patients with bleeding from angiodysplasia were enrolled. We compared them with an asymptomatic control group (incidental finding of angiodysplasia in health screening, n = 58) and bleeding control group (simultaneous finding of angiodysplasia and peptic ulcer bleeding, n = 28). Results: When patients with UGIB from angiodysplasia were compared with the asymptomatic control group, more frequent rates of nonantral location and large sized lesion (≥ 1 cm) were evident in multivariate analysis. When these patients were compared with the bleeding control group, they were older (mean age: 67.94 ± 9.16 years vs.55.07 ± 13.29 years, p = 0.03) and received less transfusions (p = 0.03). They also had more frequent rate of recurrence (40.0% vs. 20.7%, p = 0.02). Conclusions: Non-antral location and large lesions (≥ 1 cm) could be risk factors of UGIB of angiodysplasia. UGIB due to angiodysplasia was more common in older patients. Transfusion requirement would be less and a tendency of clinical recurrence might be apparent. PMID:26828247

  10. Care zoning. A pragmatic approach to enhance the understanding of clinical needs as it relates to clinical risks in acute in-patient unit settings.

    PubMed

    Taylor, Kris; Guy, Stuart; Stewart, Linda; Ayling, Mark; Miller, Graham; Anthony, Anne; Bajuk, Anne; Brun, Jo Le; Shearer, Dianne; Gregory, Rebecca; Thomas, Matthew

    2011-01-01

    The process of risk assessment which should inform and help identify clinical needs is often seen as a tick box and task-focussed approach. While on the surface this provides a sense of security that forms have been completed, we often fail to communicate in a meaningful manner about the clinical needs identified, which would assist in supporting the care planning delivery processes. A clinical practice improvement (CPI) project implemented a care zoning framework as an evidenced-based process that provides pragmatic support to nurses who are required to continually assess, implement, and evaluate plans to address clinical need across three acute mental health inpatient settings. Risk descriptors informed by the New South Wales (NSW) Mental Health Assessment & Outcome Tools (MHAOT) criteria were developed and described in behavioural contexts in order to improve the project's reliability and translation. A pragmatic traffic light tool was used to share clinical information across three agreed care zones, red (high clinical need), amber (medium clinical need), and green (low clinical need). Additionally nurses were asked to utilise a shift review form in the context of supporting the recording of care zoning and promoting action-orientated note writing. The introduction of care zoning has enthused the nursing teams and the mental health service to adopt care zoning as a supervisory framework that increases their capacity to communicate clinical needs, share information, and gain invaluable support from one another in addressing clinical needs. This includes increased opportunities for staff to feel supported in asking for assistance in understanding and addressing complex clinical presentations. PMID:21574845

  11. Utilization of Small Changes in Serum Creatinine with Clinical Risk Factors to Assess the Risk of AKI in Critically lll Adults

    PubMed Central

    Ferrer-Nadal, Asunción; Piccinni, Pasquale; Goldstein, Stuart L.; Chawla, Lakhmir S.; Alessandri, Elisa; Belluomo Anello, Clara; Bohannon, Will; Bove, Tiziana; Brienza, Nicola; Carlini, Mauro; Forfori, Francesco; Garzotto, Francesco; Gramaticopolo, Silvia; Iannuzzi, Michele; Montini, Luca; Pelaia, Paolo; Ronco, Claudio

    2014-01-01

    Background and objectives Disease biomarkers require appropriate clinical context to be used effectively. Combining clinical risk factors, in addition to small changes in serum creatinine, has been proposed to improve the assessment of AKI. This notion was developed in order to identify the risk of AKI early in a patient's clinical course. We set out to assess the performance of this combination approach. Design, setting, participants, & measurements A secondary analysis of data from a prospective multicenter intensive care unit cohort study (September 2009 to April 2010) was performed. Patients at high risk using this combination approach were defined as an early increase in serum creatinine of 0.1–0.4 mg/dl, depending on number of clinical factors predisposing to AKI. AKI was defined and staged using the Acute Kidney Injury Network criteria. The primary outcome was evolution to severe AKI (Acute Kidney Injury Network stages 2 and 3) within 7 days in the intensive care unit. Results Of 506 patients, 214 (42.2%) patients had early creatinine elevation and were deemed at high risk for AKI. This group was more likely to subsequently develop the primary endpoint (16.4% versus 1.0% [not at high risk], P<0.001). The sensitivity of this grouping for severe AKI was 92%, the specificity was 62%, the positive predictive value was 16%, and the negative predictive value was 99%. After adjustment for Sequential Organ Failure Assessment score, serum creatinine, and hazard tier for AKI, early creatinine elevation remained an independent predictor for severe AKI (adjusted relative risk, 12.86; 95% confidence interval, 3.52 to 46.97). Addition of early creatinine elevation to the best clinical model improved prediction of the primary outcome (area under the receiver operating characteristic curve increased from 0.75 to 0.83, P<0.001). Conclusion Critically ill patients at high AKI risk, based on the combination of clinical factors and early creatinine elevation, are

  12. Behavioral risk assessment in HIV Vaccine Trials Network (HVTN) clinical trials: A qualitative study exploring HVTN staff perspectives

    PubMed Central

    Andrasik, Michele Peake; Karuna, Shelly T.; Nebergall, Michelle; Koblin, Beryl A.; Kublin, Jim G.

    2013-01-01

    In HIV vaccine trials, the collection and analysis of participant behavior data associated with risk of acquiring HIV-infection is important for a number of reasons. Although the rationale for behavioral risk assessment in HIV vaccine clinical trials is clear, consistent collection of behavioral data over time and across protocols has been challenging for the HIV Vaccine Trials Network (HVTN). Integrating biomedical and behavioral research within the same preventive vaccine clinical trial has proven difficult. The HVTN conducted an internal landscape analysis to: (1) evaluate the challenges of behavioral risk assessment in HIV vaccine trials and observational studies; (2) explore the impact of the Step Study on behavioral risk assessment measures; and (3) identify strategies to overcome existing challenges and improve the quality of data resulting from behavioral risk analysis. These analyses of behavioral risk within the HVTN revealed several challenges and recommendations for improved behavioral risk data collection in future protocols. The recommendations for improvement include: (1) establishment of protocol-specific behavioral risk working groups that include social and behavioral experts; (2) provision of behavioral rationale and objectives to the development team; (3) creation of a template for geographic- and population-specific assessment of low and high risk behaviors; and (4) pilot testing of behavioral risk assessments. Results also underscored the need for routinely conducted analyses of behavioral data. PMID:23859840

  13. 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.

  14. Avascular necrosis of bone after allogeneic bone marrow transplantation: clinical findings, incidence and risk factors.

    PubMed

    Socié, G; Sélimi, F; Sedel, L; Frija, J; Devergie, A; Esperou Bourdeau, H; Ribaud, P; Gluckman, E

    1994-03-01

    In the present study we describe the incidence, clinical course, and management of avascular necrosis of bone following allogeneic bone marrow transplantation, and identify risk factors related to its development. All patients developing avascular necrosis of bone after allogeneic bone marrow transplantation between January 1974 and September 1992 were included in the analysis and were studied using the Hôpital Saint Louis Bone Marrow Transplant Database and hospital records. 27/727 allogeneic transplant recipients developed avascular necrosis leading to an 8.1% incidence at 5 years, by product limit estimate, ranging from 5% to 11.2%. Symptoms developed 119-1747 d (median 398 d) after transplantation. In these 27 patients a total of 52 joints were affected (mean 1.92 per patient, range 1-7). The hip joint was most often affected (69% of patients). All patients had joint pain that led to diagnosis by means of standard radiographs with or without the help of technetium-99 scans and/or magnetic resonance imaging. All but three patients received steroid therapy for acute graft-versus-host disease. Among 10 factors tested, three were shown to be significantly linked to an increased risk for developing avascular necrosis by multivariate analysis: male gender (relative risk (RR) 4.72, P = 0.002), age older than 16 (RR = 3.87, P = 0.004), and acute graft-versus-host disease requiring steroid therapy (RR = 6.30, P = 0.0002). 10 patients (37%) required joint replacement within 19 months (range 2-42) following diagnosis of avascular necrosis. In conclusion, avascular necrosis of bone is a frequent late complication of allogeneic bone marrow transplantation causing significant morbidity and requiring replacement surgery in one-third of affected patients. In this 18-year single-centre survey, older age, male gender and steroid therapy given for acute graft-versus-host disease were shown to independently increase the risk of avascular necrosis of bone. PMID:8043445

  15. Recipient Clinical Risk Factors Predominate in Possible Transfusion-Related Acute Lung Injury

    PubMed Central

    Toy, Pearl; Bacchetti, Peter; Grimes, Barbara; Gajic, Ognjen; Murphy, Edward L.; Winters, Jeffrey L.; Gropper, Michael A.; Hubmayr, Rolf D.; Matthay, Michael A.; Wilson, Gregory; Koenigsberg, Monique; Lee, Deanna C.; Hirschler, Nora V.; Lowell, Clifford A.; Schuller, Randy M.; Gandhi, Manish J.; Norris, Philip J.; Mair, David C.; Rosen, Rosa Sanchez; Looney, Mark R.

    2014-01-01

    Background Possible transfusion-related acute lung injury (pTRALI) cases by definition have a clear temporal relationship to an alternative recipient risk factor for acute respiratory distress syndrome (ARDS). We questioned whether transfusion factors are important for the development of pTRALI. Study Design and Methods In this nested case-control study, we prospectively identified 145 consecutive patients with pTRALI and randomly selected 163 transfused controls over a 4-year period at the University of California, San Francisco and the Mayo Clinic, Rochester. Results For pTRALI, we found evidence against transfusion being important: receipt of plasma from female donors (OR 0.82, 95% CI 0.29 – 2.3, p=0.70), total number of units transfused (OR 0.99, 95% CI 0.89 – 1.10, p=0.86), and number of red blood cell and whole blood units transfused (OR 0.78, 95% CI 0.59 –1.03, p=0.079). In contrast, we found that risk for pTRALI was associated with additional recipient factors: chronic alcohol abuse (OR 12.5, 95% CI 2.8 – 55, p<0.001), current smoker (OR 4.2, 95% CI 1.67 – 10.8, p=0.0024), shock before transfusion (OR 4.6, 95% CI 2.0 – 10.7, p<0.001), and positive fluid balance before transfusion (OR 1.32 per liter, 95% CI 1.20 – 1.44, p<0.001). Conclusion Recipient risk factors for ARDS rather than transfusion risk factors predominate in pTRALI. PMID:25488517

  16. Menopausal hormone therapy use and risk of primary liver cancer in the clinical practice research datalink.

    PubMed

    McGlynn, Katherine A; Hagberg, Katrina; Chen, Jie; Braunlin, Megan; Graubard, Barry I; Suneja, Neha; Jick, Susan; Sahasrabuddhe, Vikrant V

    2016-05-01

    Primary liver cancer occurs less commonly among women than men in almost all countries. This discrepancy has suggested that hormone levels and/or exogenous hormone use could have an effect on risk, although prior studies have reached inconsistent conclusions. Thus, the current study was conducted to examine the relationship between menopausal hormone therapy (MHT) use and development of liver cancer. A nested case-control study was conducted within the United Kingdom's Clinical Practice Research Datalink (CPRD). Controls were matched, at a 4-to-1 ratio, to women diagnosed with primary liver cancer between 1988 and 2011. A second match, based on whether the cases and controls had diabetes, was also conducted. Odds ratios (OR) and 95% confidence intervals (95%CI) for associations of MHT with liver cancer were estimated using conditional logistic regression adjusted for known risk factors. In the overall match, 339 women with liver cancer were matched to 1318 controls. MHT use was associated with a significantly lower risk of liver cancer (ORadj  = 0.58, 95%CI = 0.37-0.90) especially among users of estrogen-only MHT (ORadj = 0.44, 95%CI = 0.22-0.88) and among past users (ORadj  = 0.53, 95%CI = 0.32-0.88). Among the matched cases (n = 58) and controls (n = 232) with diabetes, the odds ratios were similar to the overall analysis (ORadj  = 0.57, 95%CI = 0.09-3.53), but did not attain statistical significance. In the current study, MHT use, especially estrogen-only MHT use, was associated with a significantly lower risk of liver cancer. These results support the need of further investigation into whether hormonal etiologies can explain the variation in liver cancer incidence between men and women. PMID:26662112

  17. 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

  18. 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

  19. Clinical and subclinical mastitis in smallholder dairy farms in Tanzania: risk, intervention and knowledge transfer.

    PubMed

    Karimuribo, E D; Fitzpatrick, J L; Bell, C E; Swai, E S; Kambarage, D M; Ogden, N H; Bryant, M J; French, N P

    2006-04-17

    In a cross-sectional study of 400 randomly selected smallholder dairy farms in the Tanga and Iringa regions of Tanzania, 14.2% (95% confidence interval (CI)=11.6-17.3) of cows had developed clinical mastitis during the previous year. The point prevalence of subclinical mastitis, defined as a quarter positive by the California Mastitis Test (CMT) or by bacteriological culture, was 46.2% (95% CI=43.6-48.8) and 24.3% (95% CI=22.2-26.6), respectively. In a longitudinal disease study in Iringa, the incidence of clinical mastitis was 31.7 cases per 100 cow-years. A randomised intervention trial indicated that intramammary antibiotics significantly reduced the proportion of bacteriologically positive quarters in the short-term (14 days post-infusion) but teat dipping had no detectable effect on bacteriological infection and CMT positive quarters. Other risk and protective factors were identified from both the cross-sectional and longitudinal included animals with Boran breeding (odds ratio (OR)=3.40, 95% CI=1.00-11.57, P<0.05 for clinical mastitis, and OR=3.51, 95% CI=1.29-9.55, P<0.01 for a CMT positive quarter), while the practice of residual calf suckling was protective for a bacteriologically positive quarter (OR=0.63, 95% CI=0.48-0.81, Pclinical and subclinical mastitis is common in smallholder dairying in Tanzania, and that some of the risk and protective factors for mastitis can be addressed by practical management of dairy cows following effective knowledge

  20. Model of good practice tools for risk reduction and clinical governance.

    PubMed

    Smagghe, D; Segers, M; Spy-Anderson, P-J; Benamou, N; Eddabbeh, N

    2005-01-01

    Information and Communication Technologies (ICT) are expected to support Healthcare Professionals in reducing medical errors, making the most relevant decisions and finding the most appropriate procedure for each patient. In particular, Knowledge Management and Decision Support Systems provide access to high quality information and to appropriate protocols. The present paper aims at comparing the approaches used in three ongoing R&D projects in order to support risk reduction and clinical governance. This comparison will lead to the presentation of a generic model of Decision Support Tools that transform shared and documented "Good Practices" into software entities that can pro-actively advice users in their daily work or when they encounter difficult situations. PMID:15923768

  1. The genetic basis of familial adenomatous polyposis and its implications for clinical practice and risk management

    PubMed Central

    Leoz, Maria Liz; Carballal, Sabela; Moreira, Leticia; Ocaña, Teresa; Balaguer, Francesc

    2015-01-01

    Familial adenomatous polyposis (FAP) is an inherited disorder that represents the most common gastrointestinal polyposis syndrome. Germline mutations in the APC gene were initially identified as responsible for FAP, and later, several studies have also implicated the MUTYH gene as responsible for this disease, usually referred to as MUTYH-associated polyposis (MAP). FAP and MAP are characterized by the early onset of multiple adenomatous colorectal polyps, a high lifetime risk of colorectal cancer (CRC), and in some patients the development of extracolonic manifestations. The goal of colorectal management in these patients is to prevent CRC mortality through endoscopic and surgical approaches. Individuals with FAP and their relatives should receive appropriate genetic counseling and join surveillance programs when indicated. This review is focused on the description of the main clinical and genetic aspects of FAP associated with germline APC mutations and MAP. PMID:25931827

  2. 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

  3. Infratentorial posterior circulation stroke in a Nigerian population: Clinical characteristics, risk factors, and predictors of outcome

    PubMed Central

    Owolabi, Lukman Femi; Ibrahim, Aliyu; Musa, Ibrahim

    2016-01-01

    Background: Posterior circulation stroke (PCS), though less common, differs from stroke in anterior circulation in many aspects. Relatively, it portends a poorer prognosis. However, there is a paucity of data from African countries, in particular, where stroke is a menace. Objective: The study aimed to evaluate the etiology, clinical characteristics, outcome, and predictors of outcome in a cohort of patients with IPCS in Northwestern Nigeria. Materials and Methods: Out of 595 patients with stroke, we prospectively analyzed 57 patients with PCS in a Tertiary Care Center in Kano, Northwestern Nigeria. Patients were analyzed for demographic data, risk factors, clinical characteristics, stroke subtypes, mortality, and predictors of mortality. Results: Posterior circulation ischemic stroke accounted for 57 (9.6%) of 595 of all strokes seen in the study period. They comprised 44 males (mean age 47.8 ± 17.7) and 13 females (mean age 46.3 ± 13.7). Overall, their age ranged between 24 and 90 (mean age 47.4 ± 16.7). However, 52.7% of the patients were < 45 years of age. The most common site affected was the cerebellum seen in 33 (57.9%) patients. Hypertension was the most common risk factor (86%). Headache and vertigo were the most common features accounting for 83.6% and 86.3%, respectively. Thirty-eight (66.7%) patients had an ischemic stroke. Twenty-one (36.8%) of the patients died during the 1-month period of follow-up. Independent predictors of death in the study were hyperglycemia on admission and hemorrhagic stroke. Conclusions: IPCS occurred in a relatively younger age group. Headache and vertigo were the most common symptoms. The independent predictors of death in the study were hyperglycemia at presentation and hemorrhagic stroke. PMID:26933349

  4. Risk factors, clinical signs, and survival in cats with a clinical diagnosis of idiopathic hypertrophic cardiomyopathy: 74 cases (1985-1989).

    PubMed

    Atkins, C E; Gallo, A M; Kurzman, I D; Cowen, P

    1992-08-15

    Population characteristics, risk factors, and survival characteristics were evaluated in 74 cats with hypertrophic cardiomyopathy (HC) seen at North Carolina State University veterinary teaching hospital from 1985 to 1989, and compared with 82 clinically normal cats. The mean (+/- SD) age of cats with HC was 6.5 (4.0) years. Neutered males were at significantly greater risk (odds ratio 3.1) than neutered females. Breed, body weight, or coat color were not determined to be risk factors for HC. Tricolor cats were significantly underrepresented, probably reflecting the male predisposition for HC and not a true risk reduction associated with coat color. Forty-one cats were without clinical signs of heart disease (murmur and/or gallop sound only), 24 were in congestive heart failure, and 9 had systemic arterial embolism, 3 of which had concomitant congestive heart failure. The median survival time for 61 cats with HC, for which survival information could be obtained and that were not euthanatized on day 1, was 732 days. Survival was not affected by age at diagnosis, breed, body weight, or sex. However, clinical signs were important in determining prognosis; cats with heart rates greater than 200 beats/min survived significantly longer (median survival greater than 1,830 days) than those with heart rates greater than or equal to 200 beats/min (median survival = 152 days). Cats without clinical signs (median survival greater than 1,830 days) survived longer than those with clinical signs, and cats in heart failure survived a median of 92 days, compared with 61 days for those with systemic arterial embolism. Analysis of survival revealed no significant difference between the 2 groups of cats with clinical signs; however, all cats with embolism and only 60% of cats with heart failure were dead 6 months after diagnosis. PMID:1517140

  5. Evaluation and applications of the clinically significant change method with the Violence Risk Scale-Sexual Offender version: implications for risk-change communication.

    PubMed

    Olver, Mark E; Beggs Christofferson, Sarah M; Wong, Stephen C P

    2015-02-01

    We examined the use of the clinically significant change (CSC) method with the Violence Risk Scale-Sexual Offender version (VRS-SO), and its implications for risk communication, in a combined sample of 945 treated sexual offenders from three international settings, followed up for a minimum 5 years post-release. The reliable change (RC) index was used to identify thresholds of clinically meaningful change and to create four CSC groups (already okay, recovered, improved, unchanged) based on VRS-SO dynamic scores and amount of change made. Outcome analyses demonstrated important CSC-group differences in 5-year rates of sexual and violent recidivism. However, when baseline risk was controlled via Cox regression survival analysis, the pattern and magnitude of CSC-group differences in sexual and violent recidivism changed to suggest that observed variation in recidivism base rates could be at least partly explained by pre-existing group differences in risk level. Implications for communication of risk-change information and applications to clinical practice are discussed. PMID:25693953

  6. The 'five rights' of clinical reasoning: an educational model to enhance nursing students' ability to identify and manage clinically 'at risk' patients.

    PubMed

    Levett-Jones, Tracy; Hoffman, Kerry; Dempsey, Jennifer; Jeong, Sarah Yeun-Sim; Noble, Danielle; Norton, Carol Anne; Roche, Janiece; Hickey, Noelene

    2010-08-01

    Acute care settings are characterised by patients with complex health problems who are more likely to be or become seriously ill during their hospital stay. Although warning signs often precede serious adverse events there is consistent evidence that 'at risk' patients are not always identified or managed appropriately. 'Failure to rescue', with rescue being the ability to recognise deteriorating patients and to intervene appropriately, is related to poor clinical reasoning skills. These factors provided the impetus for the development of an educational model that has the potential to enhance nursing students' clinical reasoning skills and consequently their ability to manage 'at risk' patients. Clinical reasoning is the process by which nurses collect cues, process the information, come to an understanding of a patient problem or situation, plan and implement interventions, evaluate outcomes, and reflect on and learn from the process. Effective clinical reasoning depends upon the nurse's ability to collect the right cues and to take the right action for the right patient at the right time and for the right reason. This paper provides an overview of a clinical reasoning model and the literature underpinning the 'five rights' of clinical reasoning. PMID:19948370

  7. 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

  8. Childhood Onset Diagnoses in a Case Series of Teens at Clinical High Risk for Psychosis

    PubMed Central

    Mazzoni, Paola; Kimhy, David; Khan, Shamir; Posner, Kelly; Maayan, Lawrence; Eilenberg, Mara; Messinger, Julie; Kestenbaum, Clarice

    2009-01-01

    Abstract Reasons Schizophrenia is typically an adult neurodevelopmental disorder that has its antecedents in childhood and adolescence. Little is known about disorders “usually first diagnosed in infancy, childhood and adolescence” (e.g., childhood-onset disorders) in “prodromal” teens at heightened clinical risk for psychotic disorder. Main Findings Childhood-onset disorders were prevalent in putatively prodromal teens, including anxiety and disruptive disorders, attention-deficit/hyperactivity disorder (ADHD), and, surprisingly, elimination disorders. These may reflect developmental antecedents in psychotic disorders such as schizophrenia. Key Data and Statistics A case series of 9 teens (ages 13–17) identified as prodromal to psychosis were evaluated with the Kiddie Schedule for Affective Disorders and Schizophrenia–Present and Lifetime Version (K-SADS-PL). Childhood-onset diagnoses commonly endorsed (threshold or subthreshold) included ADHD (5/9), oppositional defiant disorder (5/9), enuresis or encopresis (4/9), conduct disorder (2/9), separation anxiety (3/9), and transient tic disorder (2/9). Enuresis was identified in 3 of the 4 older teens (ages 15–17). Major Conclusions An understanding of the childhood-onset disorders that occur in teens at risk for psychotic illnesses, such as schizophrenia, can shed light on the pathophysiology of schizophrenia and potentially inform early identification and intervention. PMID:20035596

  9. Impact of substance use on conversion to psychosis in youth at clinical high risk of psychosis.

    PubMed

    Buchy, Lisa; Perkins, Diana; Woods, Scott W; Liu, Lu; Addington, Jean

    2014-07-01

    Elevated rates of substance use (alcohol, tobacco, cannabis) have been reported in people at clinical high risk (CHR) of developing psychosis and there is some evidence that substance use may be higher in those who convert to a psychosis compared to non-converters. However little is known about the predictive value of substance use on risk of conversion to psychosis in those at CHR of psychosis. In the current study, 170 people at CHR of psychosis were assessed at baseline on severity of alcohol, tobacco and cannabis using the Alcohol and Drug Use Scale. Participants were recruited across three sites over a four year period as part of the Enhancing the Prospective Prediction of Psychosis (PREDICT) study. Predictors of conversion to psychosis were examined using Cox proportional hazards models. Results revealed that low use of alcohol, but neither cannabis use nor tobacco use at baseline, contributed to the prediction of psychosis in the CHR sample. Prediction algorithms incorporating combinations of additional baseline variables known to be associated with psychotic conversion may result in increased predictive power compared with substance use alone. PMID:24837058

  10. 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

  11. Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology

    PubMed Central

    Rome, Benjamin N.; Kramer, Daniel B.

    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 post-market surveillance and comparative effectiveness research remains imperative. PMID:24760423

  12. 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

  13. Clinical and histological predictive risk factors of atrial fibrillation in patients undergoing open-heart surgery

    PubMed Central

    TINICA, GRIGORE; MOCANU, VERONICA; ZUGUN-ELOAE, FLORIN; BUTCOVAN, DOINA

    2015-01-01

    Postoperative atrial fibrillation (POAF) is a common complication subsequent to cardiac surgery. Various risk factors have been reported for the development of this complication; however, their precise role in POAF is unknown. In the present study, we attempted to identify clinical factors and histopathological changes in atrial tissue that may predict the development of POAF. Atrial tissue was sampled from 103 patients in sinus rhythm that had undergone open-heart surgery, including elective coronary artery bypass grafting (79.61%) and heart valve surgery (20.38%). Atrial surgical biopsies were obtained from the right atrial appendage at the site of cannulation, prior to cardiopulmonary bypass. Tissues were processed routinely for light microscopy, then stained with hematoxylin and eosin and sirius red. Microscopical exams were used to observe the atrial lesions and morphometry was conducted for quantification. In total, 37 patients (35.92%) developed POAF and atrial lesions were identified in the majority of patients in the normal postoperative sinus rhythm and POAF groups, but were most common in the POAF patients. The most common risk factors involved in developing POAF were found to be: Age of >60 years, male gender, ejection fraction of <50% and increased pulmonary hypertension. Furthermore, interstitial fibrosis and myocytolysis were the most common injuries identified. Abnormalities in atrial surgical biopsies may indicate the susceptibility of a patient to developing POAF. The present results suggest that the pre-existent alterations in the structure of the right atrium may be a major determinant in the development of POAF. PMID:26668632

  14. Assessing Suicidal Ideation in Individuals at Clinical High Risk for Psychosis

    PubMed Central

    Gill, Kelly E.; Quintero, Jean M.; Poe, S. Lucy; Moreira, Alvaro D.; Brucato, Gary; Corcoran, Cheryl M.; Girgis, Ragy R.

    2015-01-01

    Background The majority of individuals with schizophrenia and other psychotic illnesses have had suicidal ideation at some point during the illness. However, little is known about the variation in level and intensity of suicidal ideation and symptoms in the attenuated stage of psychotic illness. Our aims were to assess prevalence of suicidal ideation in this at risk group, and to examine the severity and intensity of suicidal ideation, and their relation to symptoms. Methods Suicidal ideation was assessed in 42 clinical high-risk participants using the Columbia Suicide Severity Rating Scale (C-SSRS). We hypothesized prevalence rates would be similar to what was found in previous studies, and individuals with suicidal ideation would have higher positive and negative symptoms, with poorer functioning. We assessed levels of severity and intensity of suicidal ideation related to these symptoms, and examined how depressive symptoms affected these relationships. Results Nearly half (42.9%) of participants reported having current suicidal ideation. We found no relationship to positive symptoms. However, severity and intensity of suicidal ideation was found to be related to negative symptoms and level of functioning. When controlling for depressive symptoms during exploratory analysis, this relationship still emerged. Conclusions This study adds to the literature demonstrating the complex nature of suicidal ideation in psychotic illness. The C-SSRS has shown to be helpful in determining relationships between severity and intensity in suicidal ideation in relation to specific symptoms in a research setting. PMID:25960038

  15. 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

  16. 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

  17. 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

  18. Risk Factors and Clinical Impact of Klebsiella pneumoniae Carbapenemase–Producing K. pneumoniae

    PubMed Central

    Gasink, Leanne B.; Edelstein, Paul H.; Lautenbach, Ebbing; Synnestvedt, Marie; Fishman, Neil O.

    2010-01-01

    BACKGROUND Klebsiella pneumoniae carbapenemase (KPC)–producing K. pneumoniae is an emerging pathogen with serious clinical and infection control implications. To our knowledge, no study has specifically examined risk factors for KPC-producing K. pneumoniae or its impact on mortality. METHODS To identify risk factors for infection or colonization with KPC-producing K. pneumoniae, a case-control study was performed. Case patients with KPC-producing K. pneumoniae were compared with control subjects with carbapenem-susceptible K. pneumoniae. A cohort study evaluated the association between KPC-producing K. pneumoniae and in-hospital mortality. RESULTS Fifty-six case patients and 863 control subjects were identified. In multivariable analysis, independent risk factors for KPC-producing K. pneumoniae were (1) severe illness (adjusted odds ratio [AOR], 4.31; 95% confidence interval [CI], 2.25–8.25), (2) prior fluoroquinolone use (AOR, 3.39; 95% CI, 1.50, 7.66), and (3) prior extended-spectrum cephalosporin use (AOR, 2.55; 95% CI, 1.18, 5.52). Compared with samples from other anatomic locations, K. pneumoniae isolates from blood samples were less likely to harbor KPC (AOR, 0.33; 95% CI, 0.12, 0.86). KPC-producing K. pneumoniae was independently associated with in-hospital mortality (AOR, 3.60; 95% CI, 1.87–6.91). CONCLUSIONS KPC-producing K. pneumoniae is an emerging pathogen associated with significant mortality. Our findings highlight the urgent need to develop strategies for prevention and infection control. Limiting use of certain antimicrobials, specifically fluoroquinolones and cephalosporins, use may be effective strategies. PMID:19860564

  19. Clinical features & risk factors associated with cryptosporidiosis in HIV infected adults in India

    PubMed Central

    Ajjampur, S.S. Rao; Asirvatham, J.R.; Muthusamy, Dheepa; Gladstone, B.P.; Abraham, O.C.; Mathai, Dilip; Ward, Honorine; Wanke, Christine

    2009-01-01

    Background & objectives Cryptosporidiosis is a leading cause of protracted, life threatening diarrhoea in HIV infected patients. Although data on prevalence are available for Indian patients, no information on risk factors for transmission exists. We therefore undertook this study to identify risk factors for transmission of cryptosporidiosis in HIV infected adults. Methods Both symptomatic (diarrhoeal) and asymptomatic HIV infected patients were screened for cryptosporidiosis. All Cryptosporidium spp. positive cases were enrolled in the study and interviewed to record socio-demographic information, water supply and animal contact. Data were analysed to study clinical features and potential association with species and genotype. Results Of the 28 cryptosporidial infections identified on screening 111 HIV positive patients with diarrhoea, 10 (35.7%) had chronic diarrhoea, 14 (50%) had associated fever and 8 (28.6%) had nausea. Symptomatic patients had a significantly higher number of co-infections with other enteric parasites (P=0.04) than 20 asymptomatics of 423 HIV positive individuals screened. Eleven of 17 (64%) patients with potentially zoonotic infections had diarrhoea. Patients with zoonotic species (64%) also tended to have fever more frequently than those infected with C. hominis (58%). Association between area of residence, rural or urban, water source and contact with animals and acquisition of cryptosporidiosis was not statistically significant. Interpretation & conclusions Cryptosporidiosis is an important cause of morbidity in HIV infected individuals in India, resulting in chronic diarrhoea. Risk factors for potentially zoonotic transmission of cryptosporidiosis were described in this study, but larger studies need to be done for a clearer understanding of the transmission dynamics of different cryptosporidial species in developing countries. PMID:18219083

  20. Socioeconomic and clinical factors explaining the risk of unstructured antiretroviral therapy interruptions among Kenyan adult patients.

    PubMed

    Mûnene, Edwin; Ekman, Björn

    2016-09-01

    A cross-sectional study was conducted to assess the extent of unstructured HIV treatment interruptions (TIs) and investigate the effects of socioeconomic, socio-demographic, HIV treatment-related and clinical factors on the magnitude and rate of the same among adult patients at a Kenyan regional referral center. Four hundred and twenty-one adult patients actively receiving antiretroviral therapy at Nyeri County Referral Hospital since 2003 were randomly selected to complete a health survey questionnaire. Electronic records were used to obtain their HIV treatment utilization history. The marginal effects of selected determinants on prevalence and rate of TI were assessed by fitting multiple Poisson log-linear regression models. In total, 392 patients participated in the study. HIV TI was prevalent with 64.5% having had at least one TI of 3 months or more during treatment. The risk of TI was significantly higher in those longer on treatment (prevalence ratio = 1.2, 95% confidence interval [CI] 1.12-1.28). Greater risk of TI was also associated with lower income (prevalence rate ratio [PRR] = 0.9, 95% CI 0.83-1.00), low medication adherence (PRR = 0.3, 95% CI 0.13-0.72), inconsistent treatment engagement (PRR = 0.4, 95% CI 0.19-0.75) and, contrarily, fewer adverse drug reactions (PRR = 0.9, 95% CI 0.90-0.97). Unstructured HIV TIs appear to be fairly common at the study site. The results suggest that efforts to minimize HIV TI could benefit from treatment-continuity monitoring strategies that target the high-risk sub-samples identified. PMID:26846424

  1. Protective factors in Chinese university students at clinical high risk for psychosis.

    PubMed

    Shi, Jingyu; Wang, Lu; Yao, Yuhong; Chen, Fazhan; Su, Na; Zhao, Xudong; Zhan, Chenyu

    2016-05-30

    The role of protective factors in symptom formation and prognosis in schizophrenia has been shown in many studies, but research in the early phases of psychosis is limited, particularly among the nonclinical subjects. Protective factors associated with the severity of symptoms and clinical outcomes might be meaningful to the establishment of prevention systems and to the development of optimal psychosocial interventions prior to the onset of psychosis. The present study compares self-reported levels of self-esteem, social support and resilience of 32 university students at clinical high risk for psychosis (CHR) and 32 healthy controls in a longitudinal study design. Associations between protective factors with symptoms of psychosis were assessed in the CHR group. Individuals at CHR showed significantly lower self-esteem, social support and resilience compared to healthy controls. In the CHR group, lower social support and lower self-esteem were associated with more severe positive, negative and depressive symptoms. Multiple regression analyses revealed that self-esteem was the only significant determinant for negative, depressive symptoms and global functioning. In addition, we found that subjects who were fully recovered at a 6-month follow-up survey were greater resilient and showed lower depressive symptoms at baseline. The result implied that resilience intervention could be effective on early prevention of the onset of psychosis. Moreover, implications and limitations of this study will be discussed. PMID:27031594

  2. 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. PMID:25256402

  3. Metformin use among type 2 diabetics and risk of pancreatic cancer in a clinic-based case-control study.

    PubMed

    Walker, Evan J; Ko, Andrew H; Holly, Elizabeth A; Bracci, Paige M

    2015-03-15

    A better understanding of the association between diabetes and pancreatic cancer (PC) may inform prevention and/or early detection strategies. Metformin has been associated with reduced risk of certain cancers, including PC, in some observational clinical studies. We assessed whether metformin use was associated with PC risk among those with type 2 diabetes (DM2), and whether metformin use modulated the association between DM2 and risk of PC. In total, 536 PC cases and 869 frequency-matched controls were recruited predominantly from University of California San Francisco medical clinics from 2006 to 2011. Eligible participants completed direct interviews using a structured risk factor questionnaire. The association between metformin use and PC risk was assessed using propensity score-weighted unconditional logistic regression methods in analyses restricted to diabetics and adjusted multivariable logistic models in the total study population. Ever use of metformin was not associated with PC risk in analyses restricted to DM2 (N = 170) participants (adjusted OR: 1.01, 95% CI: 0.61-1.68). In the total study population (N = 1,405) using nondiabetics as the referent group, PC risk was inversely associated with diabetes duration (ptrend  < 0.001). Further, when DM2 participants were grouped by ever/never use of metformin and compared with nondiabetics, metformin use did not affect the association between DM2 and PC risk (never users: OR: 1.44, 95% CI: 0.78-2.67; ever users: OR: 1.19, 95% CI: 0.72-1.99). Results from our clinic-based case-control study suggest that metformin use is not associated with PC risk among those with DM2 and does not alter the association between DM2 and PC risk. PMID:25091126

  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 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

  6. 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

  7. 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

  8. Development of a Simple Clinical Risk Score for Early Prediction of Severe Dengue in Adult Patients.

    PubMed

    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

    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

  9. Clinical decision making in a high-risk primary care environment: a qualitative study in the UK

    PubMed Central

    Heneghan, Carl; Thompson, Matthew; Balla, Margaret

    2012-01-01

    Objective Examine clinical reasoning and decision making in an out of hours (OOH) primary care setting to gain insights into how general practitioners (GPs) make clinical decisions and manage risk in this environment. Design Semi-structured interviews using open-ended questions. Setting A 2-month qualitative interview study conducted in Oxfordshire, UK. Participants 21 GPs working in OOH primary care. Results The most powerful themes to emerge related to dealing with urgent potentially high-risk cases, keeping patients safe and responding to their needs, while trying to keep patients out of hospital and the concept of ‘fire fighting’. There were a number of well-defined characteristics that GPs reported making presentations easy or difficult to deal with. Severely ill patients were straightforward, while the older people, with complex multisystem diseases, were often difficult. GPs stopped collecting clinical information and came to clinical decisions when high-risk disease and severe illness requiring hospital attention has been excluded; they had responded directly to the patient's needs and there was a reliable safety net in place. Learning points that GPs identified as important for trainees in the OOH setting included the importance of developing rapport in spite of time pressures, learning to deal with uncertainty and learning about common presentations with a focus on critical cues to exclude severe illness. Conclusions The findings support suggestions that improvements in primary care OOH could be achieved by including automated and regular timely feedback system for GPs and individual peer and expert clinician support for GPs with regular meetings to discuss recent cases. In addition, trainee support and mentoring to focus on clinical skills, knowledge and risk management issues specific to OOH is currently required. Investigating the stopping rules used for diagnostic closure may provide new insights into the root causes of clinical error in such a

  10. Does a too risk-averse approach to the implementation of new radiotherapy technologies delay their clinical use?

    PubMed

    Garcia, R; Nyström, H; Fiorino, C; Thwaites, D

    2015-07-01

    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

  11. Clinically Significant Depressive Symptoms as a Risk Factor for HIV Infection Among Black MSM in Massachusetts

    PubMed Central

    Reisner, Sari L.; Skeer, Margie; Bright, Donna; Cranston, Kevin; Isenberg, Deborah; Bland, Sean; Barker, Thomas A.; Mayer, Kenneth H.

    2013-01-01

    High rates of depression have been observed among men who have sex with men (MSM) relative to the general adult male population; however, a dearth of research has explored depression among Black MSM. Black MSM (n = 197) recruited via modified respondent-driven sampling between January and July 2008 completed an interviewer-administered quantitative assessment and voluntary HIV counseling and testing. Bivariate and multivariable logistic regression procedures examined the associations of demographics, behavioral HIV risk factors, and psychosocial variables with depressive symptoms by severity, using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Adjusting for demographic and behavioral variables, significant factors associated with (1) clinically significant depressive symptoms (33%; CES-D score ≥ 16): being publicly insured by Medicaid, having serodiscordant anal sex with a casual male partner, and being diagnosed with an STD in the prior 12 months; (2) moderate depressive symptoms (19%; CES-D score 16–26): having serodiscordant unprotected anal sex with a casual male partner and being diagnosed with an STD in the prior 12 months; (3) severe depressive symptoms (14%; CES-D score 27+): being publicly insured by Medicaid and reporting difficulty accessing healthcare in the past 12 months. Moderately depressed Black MSM may be more likely to engage in behaviors that place them at increased risk for HIV and other STDs. HIV prevention interventions for Black MSM may benefit from incorporating screening and/or treatment for depression, allowing MSM who are depressed to respond more effectively to behavioral change approaches. PMID:19462228

  12. 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

  13. 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

  14. Clinical characteristics and risk factors of pulmonary hypertension associated with chronic respiratory diseases: a retrospective study

    PubMed Central

    Chen, Yonghua; Liu, Chunli; Lu, Wenju; Li, Mengxi; Hadadi, Cyrus; Wang, Elizabeth Wenqian; Yang, Kai; Lai, Ning; Huang, Junyi; Li, Shiyue; Zhong, Nanshan

    2016-01-01

    Background Chronic respiratory disease-associated pulmonary hypertension (PH) is an important subtype of PH, which lacks clinical epidemiological data in China. Methods Six hundred and ninety three patients hospitalized from 2010 to 2013 were classified by echocardiography according to pulmonary arterial systolic pressure (PASP): mild (36≤ PASP <50 mmHg); moderate (50≤ PASP <70 mmHg) and severe (PASP ≥70 mmHg). Results Dyspnea (93.51%) was the most common symptom. Hemoptysis observed in the severe group (6.42%) was significantly higher than the other two groups (P<0.05). COPD (78.35%), lung bullae (44.16%), tuberculosis (including obsolete pulmonary tuberculosis) (38.82%), and bronchiectasis (30.45%) were frequently present. Mild group occupied the highest proportion (84.7%) in COPD, while severe group occupied the highest proportion (19.3%) in pulmonary embolism (P<0.01). Age, partial pressure of oxygen (PaO2), hematocrit (HCT), partial pressure of carbon dioxide (PaCO2), increase of N-terminal pro brain natriuretic peptide (NT-proBNP) and right ventricular (RV) diameter (>20 mm) were associated with moderate-to-severe PH, while RV [odds ratio (OR) =3.53, 95% CI, 2.17–5.74], NT-proBNP (OR=2.44, 95% CI, 1.51–3.95), HCT (OR=1.03, 95% CI, 1.00–1.07) and PaCO2 (OR=1.01, 95% CI, 1.00–1.03) were independent risk factors. Conclusions PH related to respiratory diseases is mostly mild to moderate, and the severity is associated with the category of respiratory disease. Increased HCT can be an independent risk factor for PH related to chronic respiratory diseases. PMID:27076929

  15. Leisure time physical activity, smoking and risk of recent symptomatic urolithiasis: Survey of stone clinic patients

    PubMed Central

    Soueidan, Michael; Bartlett, Susan J.; Noureldin, Yasser A.; Andersen, Ross E.; Andonian, Sero

    2015-01-01

    Introduction: We explore relationships between selected lifestyle factors and recent (≤6 months) symptomatic urolithiasis (RSU). Methods: Surveys querying socio-demographic, medical history, physical activity, diet and smoking were administered to a convenience sample of stone clinic patients at a tertiary care hospital. Leisure time physical activity (LTPA) was assessed with the International Physical Activity Questionnaire (long form). Multivariate logistic regression was used to identify associations between risk factors and RSU. Results: Of the 163 participants, most were male (64%) and white (78%), with a mean (standard deviation) age of 56.3 (14.2) years. The mean body mass index (BMI) was 27.3 (5.4) kg/m2 and 57 (35%) patients reported RSU. No significant (p < 0.05) differences were observed between participants with and without RSU in age, sex, ethnicity, BMI, or diet. Of the cohort, 52 (35%) participants met physical activity guidelines for walking (29%), moderate (27%) or vigorous activity (29%). LTPA did not differ significantly by RSU status. Compared to those without RSU, participants with RSU had higher rates of smoking (7% vs. 21%, p = 0.02 and had 8.5 (95% confidence interval 2.2–32.2) times the odds of being current smokers after controlling for sex, diet, and LTPA. Conclusions: Physical inactivity and smoking are common among stone clinic patients, though LPTA was not associated with RSU. Study limitations include its small sample size, selection bias, and reliance on self-reported RSU (recall bias). In addition, participants may have already been following dietary recommendations to prevent urolithiasis recurrence. Nonetheless, current smoking was a potent predictor of RSU. When desired, smokers should be referred for smoking cessation. PMID:26316909

  16. 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

  17. 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

  18. Clinical Protocols to Reduce High Risk Drinking in College Students: The College Drinking Prevention Curriculum for Health Care Providers

    ERIC Educational Resources Information Center

    Fleming, Michael

    2002-01-01

    The goal of this curriculum is to help all health care professionals -- physicians, nurses, nurse practitioners, physician assistants, social workers, health educators, counselors, psychologists, and others who work with college students -- identify and treat students who are at-risk or are having alcohol-related problems. The clinical methods…

  19. Were There "Additional Foreseeable Risks" in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials.

    PubMed

    Silverman, Henry J; Dreyfuss, Didier

    2015-01-01

    Even though the interventions were adapted from standard clinical practice, the way they were provided meant that the care given infants in the study was distinctly different from standard care, with different risk profiles. Parents should have been informed about those differences. PMID:25530226

  20. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. 50.52 Section 50.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards...

  1. 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

  2. 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

  3. 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. PMID:26210694

  4. 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.

  5. Site-Dependent Reference Point Microindentation Complements Clinical Measures for Improved Fracture Risk Assessment at the Human Femoral Neck.

    PubMed

    Jenkins, Thomas; Coutts, Louise V; D'Angelo, Stefania; Dunlop, Douglas G; Oreffo, Richard O C; Cooper, Cyrus; Harvey, Nicholas C; Thurner, Phillipp J

    2016-01-01

    In contrast to traditional approaches to fracture risk assessment using clinical risk factors and bone mineral density (BMD), a new technique, reference point microindentation (RPI), permits direct assessment of bone quality; in vivo tibial RPI measurements appear to discriminate patients with a fragility fracture from controls. However, it is unclear how this relates to the site of the most clinically devastating fracture, the femoral neck, and whether RPI provides information complementary to that from existing assessments. Femoral neck samples were collected at surgery after low-trauma hip fracture (n = 46; 17 male; aged 83 [interquartile range 77-87] years) and compared, using RPI (Biodent Hfc), with 16 cadaveric control samples, free from bone disease (7 male; aged 65 [IQR 61-74] years). A subset of fracture patients returned for dual-energy X-ray absorptiometry (DXA) assessment (Hologic Discovery) and, for the controls, a micro-computed tomography setup (HMX, Nikon) was used to replicate DXA scans. The indentation depth was greater in femoral neck samples from osteoporotic fracture patients than controls (p < 0.001), which persisted with adjustment for age, sex, body mass index (BMI), and height (p < 0.001) but was site-dependent, being less pronounced in the inferomedial region. RPI demonstrated good discrimination between fracture and controls using receiver-operating characteristic (ROC) analyses (area under the curve [AUC] = 0.79 to 0.89), and a model combining RPI to clinical risk factors or BMD performed better than the individual components (AUC = 0.88 to 0.99). In conclusion, RPI at the femoral neck discriminated fracture cases from controls independent of BMD and traditional risk factors but dependent on location. The clinical RPI device may, therefore, supplement risk assessment and requires testing in prospective cohorts and comparison between the clinically accessible tibia and the femoral neck. © 2015 American Society for Bone and Mineral

  6. 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

  7. 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

  8. BRAF-V600E expression in precursor versus differentiated dendritic cells defines clinically distinct LCH risk groups

    PubMed Central

    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.; Clausen, Björn E.; Bigley, Venetia; Collin, Matthew; Manz, Markus G.; McClain, Kenneth

    2014-01-01

    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. PMID:24638167

  9. Assessing the Clinical Impact of Risk Prediction Models With Decision Curves: Guidance for Correct Interpretation and Appropriate Use.

    PubMed

    Kerr, Kathleen F; Brown, Marshall D; Zhu, Kehao; Janes, Holly

    2016-07-20

    The decision curve is a graphical summary recently proposed for assessing the potential clinical impact of risk prediction biomarkers or risk models for recommending treatment or intervention. It was applied recently in an article in Journal of Clinical Oncology to measure the impact of using a genomic risk model for deciding on adjuvant radiation therapy for prostate cancer treated with radical prostatectomy. We illustrate the use of decision curves for evaluating clinical- and biomarker-based models for predicting a man's risk of prostate cancer, which could be used to guide the decision to biopsy. Decision curves are grounded in a decision-theoretical framework that accounts for both the benefits of intervention and the costs of intervention to a patient who cannot benefit. Decision curves are thus an improvement over purely mathematical measures of performance such as the area under the receiver operating characteristic curve. However, there are challenges in using and interpreting decision curves appropriately. We caution that decision curves cannot be used to identify the optimal risk threshold for recommending intervention. We discuss the use of decision curves for miscalibrated risk models. Finally, we emphasize that a decision curve shows the performance of a risk model in a population in which every patient has the same expected benefit and cost of intervention. If every patient has a personal benefit and cost, then the curves are not useful. If subpopulations have different benefits and costs, subpopulation-specific decision curves should be used. As a companion to this article, we released an R software package called DecisionCurve for making decision curves and related graphics. PMID:27247223

  10. Clinical decision making regarding suicide risk: Effect of patient and clinician age.

    PubMed

    Berman, Noah Chase; Tung, Esther S; Matheny, Natalie; Cohen, I Glenn; Wilhelm, Sabine

    2016-05-27

    To ascertain how patient age influences suicide risk assessment, clinicians (N = 262) read an ambiguous vignette about Bill (aged either 39 or 79 years old) and subsequently rated Bill's suicide risk and hospitalization needs. Suicide-risk ratings varied greatly and young clinicians rated Bill's suicide risk and hospitalization needs higher when he was elderly (79 years old); whereas, older clinicians rated Bill's suicide risk and need for hospitalization higher when he was younger (39 years old). The interaction between patient and clinician age may reflect a "similarity" bias, such that clinicians perceive those who are different (i.e., younger or older) to be at elevated risk. PMID:26677913

  11. [Caries risk assessment - are saliva tests as well as microbiological and clinical test procedures worthwhile?].

    PubMed

    Zimmer, S; Bizhang, M; Barthel, C; Raab, W H-M

    2008-11-01

    The recent representative survey has proven once more that people in Germany are affected by caries to a very different extent. Since caries can be prevented by risk-adjusted preventive programs, it would be helpful to have a possibility to determine the individual caries risk before cavities occur. Determination of a relative risk, risk screening and risk diagnosis are different levels of caries risk assessment. The present article provides information about which caries risk assessment options are available for different populations. A relative risk can be determined by the detection of Mutants Streptococci in caries-free 2-5-year-old children. With Dentoprog, a valid instrument for caries risk screening is available for 6-12-year-old school children. With respect to all other patients, a quantitative risk diagnosis can be roughly performed using the Cariogram which is based on the assessment of multiple risk parameters. The conclusion is that several options for caries risk assessment for different age groups are available. Nevertheless, there is no solution to how often a patient should appear for prevention in a dental office nor which preventive measures have to be taken to keep him/her healthy. Therefore it seems reasonable to roughly determine the recall frequency on the basis of the respective risk assessment and to adjust this frequency over time after the evaluation of disease progression. PMID:19039732

  12. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    PubMed

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs. PMID:26591543

  13. Early onset psychopathology and the risk for teenage pregnancy among clinically referred girls.

    PubMed

    Kovacs, M; Krol, R S; Voti, L

    1994-01-01

    An existing longitudinal data set was used to investigate the hypothesis that a depressive disorder in childhood increases the risk of an adolescent pregnancy. Depression is characterized by low self-esteem, lowered concern about one's personal welfare, passivity, and impaired motivation--all of which may prevent teenage girls from taking steps to protect themselves from pregnancy. The 83 subjects had been referred to a child psychiatric clinic (86%) or a general medical facility (12%) in Pittsburgh, Pennsylvania, between the ages of 8-13 years (average age at intake, 11.5 years). They underwent 4 clinical assessments in the first year of study participation and 2 assessments in each subsequent year. 65 girls experienced 1 or more DSM-III-R defined depressive episodes during the study period; the rest, who served as psychopathologic controls, had conduct disorders. 25 of the 83 subjects (30%, compared to the national average of 24%) had documented pregnancies by the age of 18 years. 28% of the pregnant teens had a history of early onset depression compared with 66% of their nonpregnant counterparts. On the other hand, 76% of the pregnant teens had been diagnosed with a conduct disorder by the age of 18 compared with 24% of the nonpregnant girls. Preliminary analysis further indicated that teenage pregnancy was associated with having been born out of wedlock or to a mother aged 18 years or younger; living in an intact family at time of study enrollment and socioeconomic status were not significant correlates. In the multivariate analysis, however, only two factors retained significance: a conduct disorder diagnosis in childhood (mean time to first pregnancy was 17.3 years compared to 18.7 years among remaining subjects) and race (Blacks tended to become pregnant by 17.4 years compared to an average of 18.7 years for Whites). No significant interaction was detected between a conduct disorder and race. These findings suggest that educational interventions aimed at

  14. 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.

  15. 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

  16. 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

  17. 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. PMID:26165958

  18. The future of monitoring in clinical research - a holistic approach: linking risk-based monitoring with quality management principles.

    PubMed

    Ansmann, Eva B; Hecht, Arthur; Henn, Doris K; Leptien, Sabine; Stelzer, Hans Günther

    2013-01-01

    Since several years risk-based monitoring is the new "magic bullet" for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP. PMID:23382708

  19. 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…

  20. 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…

  1. 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:…

  2. Validation of a modified clinical risk score to predict cancer-specific survival for stage II colon cancer

    PubMed Central

    Oliphant, Raymond; Horgan, Paul G; Morrison, David S; McMillan, Donald C

    2015-01-01

    Many patients with stage II colon cancer will die of their disease despite curative surgery. Therefore, identification of patients at high risk of poor outcome after surgery for stage II colon cancer is desirable. This study aims to validate a clinical risk score to predict cancer-specific survival in patients undergoing surgery for stage II colon cancer. Patients undergoing surgery for stage II colon cancer in 16 hospitals in the West of Scotland between 2001 and 2004 were identified from a prospectively maintained regional clinical audit database. Overall and cancer-specific survival rates up to 5 years were calculated. A total of 871 patients were included. At 5 years, cancer-specific survival was 81.9% and overall survival was 65.6%. On multivariate analysis, age ≥75 years (hazard ratio (HR) 2.11, 95% confidence intervals (CI) 1.57–2.85; P<0.001) and emergency presentation (HR 1.97, 95% CI 1.43–2.70; P<0.001) were independently associated with cancer-specific survival. Age and mode of presentation HRs were added to form a clinical risk score of 0–2. The cancer-specific survival at 5 years for patients with a cumulative score 0 was 88.7%, 1 was 78.2% and 2 was 65.9%. These results validate a modified simple clinical risk score for patients undergoing surgery for stage II colon cancer. The combination of these two universally documented clinical factors provides a solid foundation for the examination of the impact of additional clinicopathological and treatment factors on overall and cancer-specific survival. PMID:25487740

  3. Drug adverse events and drop-out risk: a clinical case.

    PubMed

    Scoyni, R M; Aiello, L; Trani, I; Felli, B; Masin, A M R; Camponi, V; Dignazio, L; Cortese, M; Pacitti, M T; Carratelli, D; Morocutti, C

    2007-01-01

    We report a brief discussion on a clinical case of a female patient, 85 years old, affected by severe cognitive impairment and chronic obstructive pulmonary disease (COPD). The patient was not taking drugs at home (apart from promazine: 10 drops when necessary to control her behavioral diseases). A previous neuropsychological evaluation had shown a severe cognitive impairment MMSE=16/30; ADL=3/6; IADL=0/8) due to multiple brain ischemic areas (confirmed in 2003 by MRI neuroimaging). When the patient was admitted to our center she was able to perform some basic activities of daily living such as eating and walking and was not too confused. She was included in cognitive rehabilitation groups. Since she showed signs of Parkinsonism, a therapy based on omeprazol 20mg, acetylsalicylic acid, donepezil 10mg, pramipexol 0.18 mg, nimodipine 10 drops, levodopa+carbidopa 100/25mg was started. A few days later she became sleepy during daytime and, once, she lost her balance and fell. She was not self-sufficient any more. At first this was attributed to a lung infection that the patient had, but her state continue after the infection was completely cured with appropriate antibiotics therapy. At that point an adverse drug reaction was suspected and therapy with pramipexol 0.18 mg was interrupted. In a few days the patient regained her previous level of consciousness and self-sufficiency. We consider this a typical case of complex management in a patient with dementia and comorbidity in which adverse drug reactions can play an important role in lowering the level of cognitive functions. In this case the relationship with the family of the patient was made difficult by the attitude of the patient's daughter who decided, after the onset of the adverse drug reaction, to interrupt her mother's stay in our center even at risk of the worst consequences. PMID:17317475

  4. Risk factor model to predict a missed clinic appointment in an urban, academic, and underserved setting.

    PubMed

    Torres, Orlando; Rothberg, Michael B; Garb, Jane; Ogunneye, Owolabi; Onyema, Judepatricks; Higgins, Thomas

    2015-04-01

    In the chronic care model, a missed appointment decreases continuity, adversely affects practice efficiency, and can harm quality of care. The aim of this study was to identify predictors of a missed appointment and develop a model to predict an individual's likelihood of missing an appointment. The research team performed a retrospective study in an urban, academic, underserved outpatient internal medicine clinic from January 2008 to June 2011. A missed appointment was defined as either a "no-show" or cancellation within 24 hours of the appointment time. Both patient and visit variables were considered. The patient population was randomly divided into derivation and validation sets (70/30). A logistic model from the derivation set was applied in the validation set. During the period of study, 11,546 patients generated 163,554 encounters; 45% of appointments in the derivation sample were missed. In the logistic model, percent previously missed appointments, wait time from booking to appointment, season, day of the week, provider type, and patient age, sex, and language proficiency were all associated with a missed appointment. The strongest predictors were percentage of previously missed appointments and wait time. Older age and non-English proficiency both decreased the likelihood of missing an appointment. In the validation set, the model had a c-statistic of 0.71, and showed no gross lack of fit (P=0.63), indicating acceptable calibration. A simple risk factor model can assist in predicting the likelihood that an individual patient will miss an appointment. PMID:25299396

  5. Binocular Depth Perception in Individuals at Clinical High Risk for Psychosis: no evidence of dysfunction

    PubMed Central

    Barbato, Mariapaola; Addington, Jean

    2014-01-01

    Objective In the last decade the interest in the role of the visual system in schizophrenia has grown, with evidence pointing to dysfunction in bottom-up visual processing that leads to early visual processing deficits. A fundamental component of visual perception is binocular depth perception (BDP), i.e. depth perception derived by the difference between the images impressed upon the left and right retina. Two studies reported impaired BDP in schizophrenia and suggested a possible developmental deficit of brain structures involved in early visual processing. The aim of this study was to examine BDP in a young population at clinical high risk (CHR) of developing psychosis to determine if this dysfunction is present in this potentially pre-psychotic period. Methods Forty-two CHR participants and 44 healthy controls were assessed using a computerized test of depth perception; a subsample completed a test of stereopsis. The computerized test was comprised of two trial blocks, with four conditions at increasing level of difficulty, where participants were asked to discriminate the relative depth of two stimuli simultaneously presented on the screen. Results BDP was not impaired in the CHR group, whose performance was similar to that of the control group on both measures. For the CHR group performance in both tests was not correlated to positive symptoms. Conclusions These results indicate that BDP is preserved in individuals at CHR for psychosis and impaired BDP should not be considered a vulnerability marker for schizophrenia. Nevertheless future studies should verify BDP's potential power in predicting schizophrenia. PMID:24188117

  6. 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. PMID:27000155

  7. 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.

  8. Clinical and community risk models of incident tooth loss in postmenopausal women from the Buffalo Osteo Perio Study

    PubMed Central

    Bole, Christopher; Wactawski-Wende, Jean; Hovey, Kathleen; Genco, Robert J.; Hausmann, Ernest

    2010-01-01

    Objectives While risk factors for tooth loss in adults have been identified, limited studies describing factors associated with incident tooth loss in postmenopausal women exist. This study assessed both clinical and non-clinical risk factors for incident tooth loss. Methods Postmenopausal women (N= 1,341) were recruited between 1997–2000 from 1847 eligible Observational Study participants of the Buffalo, NY center of the Women’s Health Initiative who had complete dental examinations to assess alveolar bone height, soft tissue attachment and general oral health, and completed questionnaires concerning demographics, general health, lifestyle and oral health (72.6% participation rate). Five years later (2002–2005), 1021 women (76.1%) repeated these examinations and questionnaires. Incident tooth loss was determined by oral examination Results After an average 5.1 years of follow-up (SD, 0.38), a total of 323 teeth were lost in 293 women, resulting in 28.7% of women with incident loss of at least one tooth. In multivariable models, diabetes history, gum disease history, smoking, previous tooth loss, BMI and plaque index, baseline clinical measures including alveolar crestal height (ACH) (OR=1.22 per mm loss, 95% CI 1.11, 1.35), clinical attachment loss (CAL) (OR=1.13 per mm loss, 95% CI 1.05, 1.23) and pocket depth (PD) (OR=1.26 per mm loss, 95% CI 1.13, 1.41) were significant risk factors of incident tooth loss. In a community model that included no clinical measures, diabetes history (OR=2.45, 95% CI 1.26, 4.77), prior gum disease (OR=1.97, 95% CI 1.43, 2.70), ever smoking (OR=1.42, 95% CI 1,06, 1.89), number of teeth lost at baseline (OR=1.05 per tooth, 95% CI 1.02, 1.08) and BMI (OR=1.15 per 5 km/m2 increase, 95% CI 1.01, 1.33) were associated with an increased risk of incident tooth loss. Conclusions Clinical and questionnaire based models were found to provide similar risk estimates for incident tooth loss in postmenopausal women. These models identified

  9. A clinical economics workstation for risk-adjusted health care cost management.

    PubMed Central

    Eisenstein, E. L.; Hales, J. W.

    1995-01-01

    This paper describes a healthcare cost accounting system which is under development at Duke University Medical Center. Our approach differs from current practice in that this system will dynamically adjust its resource usage estimates to compensate for variations in patient risk levels. This adjustment is made possible by introducing a new cost accounting concept, Risk-Adjusted Quantity (RQ). RQ divides case-level resource usage variances into their risk-based component (resource consumption differences attributable to differences in patient risk levels) and their non-risk-based component (resource consumption differences which cannot be attributed to differences in patient risk levels). Because patient risk level is a factor in estimating resource usage, this system is able to simultaneously address the financial and quality dimensions of case cost management. In effect, cost-effectiveness analysis is incorporated into health care cost management. PMID:8563361

  10. 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

  11. Assessment of uncertainties in radiation-induced cancer risk predictions at clinically relevant doses

    PubMed Central

    Nguyen, J.; Moteabbed, M.; Paganetti, H.

    2015-01-01

    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

  12. HIV Prevalence, Risk Behavior, Knowledge and Beliefs among Women Seeking Care at a Sexually Transmitted Infection Clinic in Mumbai, India

    PubMed Central

    Cooperman, Nina A.; Shastri, Jayanthi S.; Shastri, Aditi; Schoenbaum, Ellie

    2013-01-01

    Three hundred women presenting to a sexually transmitted infection clinic in Mumbai, India were surveyed and HIV tested. Thirty-nine percent were HIV-infected; 80% were current sex workers, and HIV-infection was not significantly associated with past-year sex work. Only 44% always used condoms with their non-commercial sex partners. Most believed condom preparation is a male responsibility (58%), condom use is a sign that partner trust is lacking (84%), and, if a woman asks her partner to use a condom, he will lose respect for her (65%). All women at STI clinics in India need HIV testing and culturally sensitive risk intervention. PMID:23659311

  13. Does epilepsy in multiplex autism pedigrees define a different subgroup in terms of clinical characteristics and genetic risk?

    PubMed Central

    2013-01-01

    Background Autism spectrum disorders (ASD) and epilepsy frequently occur together. Prevalence rates are variable, and have been attributed to age, gender, comorbidity, subtype of pervasive developmental disorder (PDD) and risk factors. Recent studies have suggested disparate clinical and genetic settings depending on simplex or multiplex autism. The aim of this study was to assess: 1) the prevalence of epilepsy in multiplex autism and its association with genetic and non-genetic risk factors of major effect, intellectual disability and gender; and 2) whether autism and epilepsy cosegregate within multiplex autism families. Methods We extracted from the Autism Genetic Resource Exchange (AGRE) database (n = 3,818 children from 1,264 families) all families with relevant medical data (n = 664 children from 290 families). The sample included 478 children with ASD and 186 siblings without ASD. We analyzed the following variables: seizures, genetic and non-genetic risk factors, gender, and cognitive functioning as assessed by Raven’s Colored Progressive Matrices (RCPM) and Vineland Adaptive Behavior Scales (VABS). Results The prevalence of epilepsy was 12.8% in cases with ASD and 2.2% in siblings without ASD (P <10-5). With each RCPM or VABS measure, the risk of epilepsy in multiplex autism was significantly associated with intellectual disability, but not with gender. Identified risk factors (genetic or non-genetic) of autism tended to be significantly associated with epilepsy (P = 0.052). When children with prematurity, pre- or perinatal insult, or cerebral palsy were excluded, a genetic risk factor was reported for 6/59 (10.2%) of children with epilepsy and 12/395 (3.0%) of children without epilepsy (P = 0.002). Finally, using a permutation test, there was significant evidence that the epilepsy phenotype co-segregated within families (P <10-4). Conclusions Epilepsy in multiplex autism may define a different subgroup in terms of clinical

  14. Demonstration of the Effect of Generic Anatomical Divisions versus Clinical Protocols on Computed Tomography Dose Estimates and Risk Burden

    PubMed Central

    Moorin, Rachael E.; Gibson, David A. J.; Forsyth, Rene K.; Fox, Richard

    2014-01-01

    Objective Choosing to undertake a CT scan relies on balancing risk versus benefit, however risks associated with CT scanning have generally been limited to broad anatomical locations, which do not provided adequate information to evaluate risk against benefit. Our study aimed to determine differences in radiation dose and risk estimates associated with modern CT scanning examinations when computed for clinical protocols compared with those using anatomical area. Methods Technical data were extracted from a tertiary hospital Picture Archiving Communication System for random samples of 20–40 CT examinations per adult clinical CT protocol. Organ and whole body radiation dose were calculated using ImPACT Monte Carlo simulation software and cancer incidence and mortality estimated using BEIR VII age and gender specific lifetime attributable risk weights. Results Thirty four unique CT protocols were identified by our study. When grouped according to anatomic area the radiation dose varied substantially, particularly for abdominal protocols. The total estimated number of incident cancers and cancer related deaths using the mean dose of anatomical area were 86 and 69 respectively. Using more specific protocol doses the estimates rose to 214 and 138 incident cancers and cancer related deaths, at least doubling the burden estimated. Conclusions Modern CT scanning produces a greater diversity of effective doses than much of the literature describes; where a lack of focus on actual scanning protocols has produced estimates that do not reflect the range and complexity of modern CT practice. To allow clinicians, patients and policy makers to make informed risk versus benefit decisions the individual and population level risks associated with modern CT practices are essential. PMID:24878841

  15. The communication of the radiation risk from CT in relation to its clinical benefit in the era of personalized medicine: part 2: benefits versus risk of CT.

    PubMed

    Westra, Sjirk J

    2014-10-01

    In order to personalize the communication of the CT risk, we need to describe the risk in the context of the clinical benefit of CT, which will generally be much higher, provided a CT scan has a well-established clinical indication. However as pediatric radiologists we should be careful not to overstate the benefit of CT, being aware that medico-legal pressures and the realities of health care economics have led to overutilization of the technology. And even though we should not use previously accumulated radiation dose to a child as an argument against conducting a clinically indicated scan (the "sunk-cost" bias), we should consider patients' radiation history in the diagnostic decision process. As a contribution to future public health, it makes more sense to look for non-radiating alternatives to CT in the much larger group of basically healthy children who are receiving occasional scans for widely prevalent conditions such as appendicitis and trauma than to attempt lowering CT use in the smaller group of patients with chronic conditions with a limited life expectancy. When communicating the CT risk with individual patients and their parents, we should acknowledge and address their concerns within the framework of informed decision-making. When appropriate, we may express the individual radiation risk, based on estimates of summated absorbed organ dose, as an order of magnitude rather than as an absolute number, and compare this with the much larger natural cancer incidence over a child's lifetime, and with other risks in medicine and daily life. We should anticipate that many patients cannot make informed decisions on their own in this complex matter, and we should offer our guidance while maintaining respect for patient autonomy. Proper documentation of the informed decision process is important for future reference. In concert with our referring physicians, pediatric radiologists are well-equipped to tackle the complexities associated with the communication

  16. Risk Factor Analysis for the Immunogenicity of Adalimumab Associated with Decreased Clinical Response in Chinese Patients with Psoriasis.

    PubMed

    Chiu, Hsien-Yi; Wang, Ting-Shun; Chan, Chih-Chieh; Lin, Sung-Jan; Tsai, Tsen-Fang

    2015-07-01

    Although anti-drug antibodies against biologics have been associated with decreased clinical efficacy, the immunogenicity of biologics seems to vary between drugs, diseases and ethnicities. This study aims to investigate the predictors for the formation of anti-adalimumab antibodies (AAA) and the clinical consequences of AAA formation. In 53 Chinese psoriatic patients treated with adalimumab, AAA was detected in 50.9%. Differences in Psoriasis Area and Severity Index 75 (PASI75) response rates among patients with and without AAA were significant (44.4% vs. 88.5%; p = 0.001). Patients with AAA had significantly lower trough concentrations of adalimumab than those without AAA. Risk factor analysis showed that treatment interruption, low trough adalimumab concentration, absence of concomitant methotrexate use and biologics switching were associated with a higher AAA titre. The treatment pattern of biologics influences the risk of AAA formation, thereby leading to reduced efficacy of adalimumab. PMID:25673333

  17. Universal HIV screening at a major metropolitan TB clinic: HIV prevalence and high-risk behaviors among TB patients.

    PubMed Central

    Weis, S E; Foresman, B; Cook, P E; Matty, K J

    1999-01-01

    OBJECTIVES: This study assessed the outcome of implementing a policy of universal screening of patients with tuberculosis (TB) for HIV infection at a major metropolitan public health TB clinic. METHODS: HIV serologic testing was completed on 768 (93%) of 825 eligible patients. Ninety-eight HIV-positive cases (13%) were compared with 670 HIV-negative cases. The presence of adult HIV risk factors was determined by structured interview and review of medical records. RESULTS: One or more HIV risk factors were present in 93% of HIV-positive cases and 42% of HIV-negative cases. CONCLUSIONS: The metropolitan TB clinic is well suited for HIV screening, and HIV-antibody testing and counseling should be provided to all TB patients. PMID:9987468

  18. Depression and Anxiety During Pregnancy: Evaluating the Literature in Support of Clinical Risk-Benefit Decision-Making.

    PubMed

    Dalke, Katharine Baratz; Wenzel, Amy; Kim, Deborah R

    2016-06-01

    Depression and anxiety during pregnancy are common, and patients and providers are faced with complex decisions regarding various treatment modalities. A structured discussion of the risks and benefits of options with the patient and her support team is recommended to facilitate the decision-making process. This clinically focused review, with emphasis on the last 3 years of published study data, evaluates the major risk categories of medication treatments, namely pregnancy loss, physical malformations, growth impairment, behavioral teratogenicity, and neonatal toxicity. Nonpharmacological treatment options, including neuromodulation and psychotherapy, are also briefly reviewed. Specific recommendations, drawn from the literature and the authors' clinical experience, are also offered to help guide the clinician in decision-making. PMID:27091646

  19. Understanding and predicting suicidality using a combined genomic and clinical risk assessment approach.

    PubMed

    Niculescu, A B; Levey, D F; Phalen, P L; Le-Niculescu, H; Dainton, H D; Jain, N; Belanger, E; James, A; George, S; Weber, H; Graham, D L; Schweitzer, R; Ladd, T B; Learman, R; Niculescu, E M; Vanipenta, N P; Khan, F N; Mullen, J; Shankar, G; Cook, S; Humbert, C; Ballew, A; Yard, M; Gelbart, T; Shekhar, A; Schork, N J; Kurian, S M; Sandusky, G E; Salomon, D R

    2015-11-01

    biomarkers for suicidality. We also identified other potential therapeutic targets or biomarkers for drugs known to mitigate suicidality, such as omega-3 fatty acids, lithium and clozapine. Overall, 14% of the top candidate biomarkers also had evidence for involvement in psychological stress response, and 19% for involvement in programmed cell death/cellular suicide (apoptosis). It may be that in the face of adversity (stress), death mechanisms are turned on at a cellular (apoptosis) and organismal level. Finally, we tested the top increased and decreased biomarkers from the discovery for suicidal ideation (CADM1, CLIP4, DTNA, KIF2C), prioritization with CFG for prior evidence (SAT1, SKA2, SLC4A4), and validation for behavior in suicide completers (IL6, MBP, JUN, KLHDC3) steps in a completely independent test cohort of psychiatric participants for prediction of suicidal ideation (n=108), and in a future follow-up cohort of psychiatric participants (n=157) for prediction of psychiatric hospitalizations due to suicidality. The best individual biomarker across psychiatric diagnoses for predicting suicidal ideation was SLC4A4, with a receiver operating characteristic (ROC) area under the curve (AUC) of 72%. For bipolar disorder in particular, SLC4A4 predicted suicidal ideation with an AUC of 93%, and future hospitalizations with an AUC of 70%. SLC4A4 is involved in brain extracellular space pH regulation. Brain pH has been implicated in the pathophysiology of acute panic attacks. We also describe two new clinical information apps, one for affective state (simplified affective state scale, SASS) and one for suicide risk factors (Convergent Functional Information for Suicide, CFI-S), and how well they predict suicidal ideation across psychiatric diagnoses (AUC of 85% for SASS, AUC of 89% for CFI-S). We hypothesized a priori, based on our previous work, that the integration of the top biomarkers and the clinical information into a universal predictive measure (UP-Suicide) would

  20. 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

  1. 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

  2. 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

  3. 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

  4. [Crohn's disease and cancer risk. Incidence/prevalence, clinical characteristics, and potential prevention strategies].

    PubMed

    Allgayer, Hubert; Holtmeier, Wolfgang; Dietrich, Christoph F

    2007-09-15

    Epidemiologic data concerning the risk for colorectal cancer in ulcerative colitis are based on a variety of large and well-conducted cohort studies. Guidelines for tumor prevention have been published by the German Gastroenterology Society (DGVS) in 2004. By contrast, the risk constellations in Crohn's disease are less clear and guidelines are lacking. Based on a recent literature search (PubMed March 2007), the published data predominantly expressed as relative risk and/or standardized incidence/mortality ratio are critically reviewed with recommendations for tumor prevention strategies based on individual risk constellations. PMID:17879011

  5. 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

  6. 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

  7. Clinical characteristics and risk factors of an outbreak with scrub typhus in previously unrecognized areas, Jiangsu province, China 2013.

    PubMed

    Hu, Jianli; Tan, Zhongming; Ren, Dafei; Zhang, Xiang; He, Yilin; Bao, Changjun; Liu, Dapeng; Yi, Qianhua; Qian, Weijuan; Yin, Jun; Xu, Zhen; Yu, Chunxia; Wang, Shenjiao; Wu, Bin; Yang, Haiyu; Yue, Ming; Zhang, Yun; Liu, Wendong; Zhu, Yefei; Zhou, Minghao; Tang, Fenyang

    2015-01-01

    Scrub typhus, caused by Orientia tsutsugamushi, has emerged recently in Jingjiang City, China where the disease had not been known to exist. We analyzed epidemiological data, clinical characteristics and risk factors of scrub typhus outbreak in Jingjiang City, 2013. The 271 clinically diagnosed patients were predominantly farmers 50 to 69 years old and the peak of onset was early to mid-November. For the 187 laboratory-confirmed cases, the major clinical manifestations of the patients were fever (100%), eschar (88.2%), rash (87.7%), chills (87.7%), and headache (66.8%). A community-based case-control study was carried out to investigate the risk factors of the scrub typhus outbreak. Bundling or moving waste straw (OR=9.0, 95%CI 4.6-17.8) and living at the edge of village (OR=0.6, 95%CI 0.4-0.9) posed the highest risks through single- and multi-variable conditional logistic regression. Phylogenetic analysis of the 56-kDa TSA gene showed that the new cluster (GB-C2) and the previously reported cluster (GB-C1) of O. tsutsugamushi were associated with this outbreak. These findings are useful for the establishment of a detailed control strategy for scrub typhus infection in previously unrecognized areas of Jiangsu Province, China. PMID:25954814

  8. Recurrent copy number variations as risk factors for neurodevelopmental disorders: critical overview and analysis of clinical implications.

    PubMed

    Torres, Fátima; Barbosa, Mafalda; Maciel, Patrícia

    2016-02-01

    Neurodevelopmental disorders (NDs) encompass a spectrum of neuropsychiatric manifestations. Chromosomal regions 1q21.1, 3q29, 15q11.2, 15q13.3, 16p11.2, 16p13.1 and 22q11 harbour rare but recurrent CNVs that have been uncovered as being important risk factors for several of these disorders. These rearrangements may underlie a broad phenotypical spectrum, ranging from normal development, to learning problems, intellectual disability (ID), epilepsy and psychiatric diseases, such as autism spectrum disorders (ASDs) and schizophrenia (SZ). The highly increased risk of developing neurodevelopmental phenotypes associated with some of these CNVs makes them an unavoidable element in the clinical context in paediatrics, neurology and psychiatry. However, and although finding these risk loci has been the goal of neuropsychiatric genetics for many years, the translation of this recent knowledge into clinical practice has not been trivial. In this article, we will: (1) review the state of the art on recurrent CNVs associated with NDs, namely ASD, ID, epilepsy and SZ; (2) discuss the models used to dissect the underlying neurobiology of disease, (3) discuss how this knowledge can be used in clinical practice. PMID:26502893

  9. Clinical Characteristics and Risk Factors of an Outbreak with Scrub Typhus in Previously Unrecognized Areas, Jiangsu Province, China 2013

    PubMed Central

    Zhang, Xiang; He, Yilin; Bao, Changjun; Liu, Dapeng; Yi, Qianhua; Qian, Weijuan; Yin, Jun; Xu, Zhen; Yu, Chunxia; Wang, Shenjiao; Wu, Bin; Yang, Haiyu; Yue, Ming; Zhang, Yun; Liu, Wendong; Zhu, Yefei; Zhou, Minghao; Tang, Fenyang

    2015-01-01

    Scrub typhus, caused by Orientia tsutsugamushi, has emerged recently in Jingjiang City, China where the disease had not been known to exist. We analyzed epidemiological data, clinical characteristics and risk factors of scrub typhus outbreak in Jingjiang City, 2013. The 271 clinically diagnosed patients were predominantly farmers 50 to 69 years old and the peak of onset was early to mid-November. For the 187 laboratory-confirmed cases, the major clinical manifestations of the patients were fever (100%), eschar (88.2%), rash (87.7%), chills (87.7%), and headache (66.8%). A community-based case-control study was carried out to investigate the risk factors of the scrub typhus outbreak. Bundling or moving waste straw (OR=9.0, 95%CI 4.6-17.8) and living at the edge of village (OR=0.6, 95%CI 0.4-0.9) posed the highest risks through single- and multi-variable conditional logistic regression. Phylogenetic analysis of the 56-kDa TSA gene showed that the new cluster (GB-C2) and the previously reported cluster (GB-C1) of O. tsutsugamushi were associated with this outbreak. These findings are useful for the establishment of a detailed control strategy for scrub typhus infection in previously unrecognized areas of Jiangsu Province, China. PMID:25954814

  10. Risk factors associated with short-term post-treatment outcomes of clinical mastitis.

    PubMed

    Pinzón-Sánchez, C; Ruegg, P L

    2011-07-01

    The objectives of this study were to characterize 60-d outcomes after treatment of mild (abnormal milk) and moderate (abnormal milk and abnormal udder) cases of clinical mastitis (CM) occurring in a single quarter of cows on Wisconsin farms (n=4) and to determine risk factors associated with those outcomes. Duplicate milk samples were collected from the affected quarter of each cow for microbiological analysis at the onset of CM (PRE) and 21 d later (POST). Cows were treated only in the affected quarter using an intramammary product containing 125 mg of ceftiofur. Bacteriological cure was defined as absence of pathogens in the POST sample obtained from the enrolled quarter. Recurrence was defined for the cow when CM occurred after the milk-withholding period for the enrolled case of CM. Retention in the herd was defined when a cow was retained within the herd for the 60-d follow-up period. Somatic cell count reduction (SCCR) was defined at the cow level as somatic cell count (SCC) below 200,000 cells/mL at the Dairy Herd Improvement Association test day occurring between 21 to 55 d post-treatment. The effects of farm, days in milk, parity, severity, microbiological diagnosis at PRE, previous milk yield, previous SCC, previous occurrence of CM and treatment duration on selected post-treatment outcomes were assessed using Chi-squared analysis and logistic regression. Microbiological results at PRE were distributed as: Escherichia coli (n=14), Klebsiella spp. (n=11), Enterobacter spp. (n=8), Serratia spp. (n=7), other gram-negative species (n=3), Streptococcus spp. (n=25), coagulase-negative staphylococci (n=4); Staphylococcus aureus (n=1); Streptococcus agalactiae (n=1), other gram-positive species (n=9), and culture negative (n=60). Treated quarters were more likely to experience bacteriological cure when the cow experienced CM for the first time in the lactation and when no pathogen was recovered from PRE milk samples obtained from the enrolled quarter. Parity and

  11. Understanding and predicting suicidality using a combined genomic and clinical risk assessment approach

    PubMed Central

    Niculescu, A B; Levey, D F; Phalen, P L; Le-Niculescu, H; Dainton, H D; Jain, N; Belanger, E; James, A; George, S; Weber, H; Graham, D L; Schweitzer, R; Ladd, T B; Learman, R; Niculescu, E M; Vanipenta, N P; Khan, F N; Mullen, J; Shankar, G; Cook, S; Humbert, C; Ballew, A; Yard, M; Gelbart, T; Shekhar, A; Schork, N J; Kurian, S M; Sandusky, G E; Salomon, D R

    2015-01-01

    biomarkers for suicidality. We also identified other potential therapeutic targets or biomarkers for drugs known to mitigate suicidality, such as omega-3 fatty acids, lithium and clozapine. Overall, 14% of the top candidate biomarkers also had evidence for involvement in psychological stress response, and 19% for involvement in programmed cell death/cellular suicide (apoptosis). It may be that in the face of adversity (stress), death mechanisms are turned on at a cellular (apoptosis) and organismal level. Finally, we tested the top increased and decreased biomarkers from the discovery for suicidal ideation (CADM1, CLIP4, DTNA, KIF2C), prioritization with CFG for prior evidence (SAT1, SKA2, SLC4A4), and validation for behavior in suicide completers (IL6, MBP, JUN, KLHDC3) steps in a completely independent test cohort of psychiatric participants for prediction of suicidal ideation (n=108), and in a future follow-up cohort of psychiatric participants (n=157) for prediction of psychiatric hospitalizations due to suicidality. The best individual biomarker across psychiatric diagnoses for predicting suicidal ideation was SLC4A4, with a receiver operating characteristic (ROC) area under the curve (AUC) of 72%. For bipolar disorder in particular, SLC4A4 predicted suicidal ideation with an AUC of 93%, and future hospitalizations with an AUC of 70%. SLC4A4 is involved in brain extracellular space pH regulation. Brain pH has been implicated in the pathophysiology of acute panic attacks. We also describe two new clinical information apps, one for affective state (simplified affective state scale, SASS) and one for suicide risk factors (Convergent Functional Information for Suicide, CFI-S), and how well they predict suicidal ideation across psychiatric diagnoses (AUC of 85% for SASS, AUC of 89% for CFI-S). We hypothesized a priori, based on our previous work, that the integration of the top biomarkers and the clinical information into a universal predictive measure (UP-Suicide) would

  12. Management of high-risk popliteal vascular blunt trauma: clinical experience with 62 cases

    PubMed Central

    Pourzand, Ali; Fakhri, Bassir A; Azhough, Ramin; Hassanzadeh, Mohammad Ali; Hashemzadeh, Shahryar; Bayat, Amrollah M

    2010-01-01

    Purpose: The purpose of this study is to report the clinical and functional outcomes of patients, treated between 2004 and 2009, with high-risk popliteal vascular injuries due to compound fractures about the knee. Patients and methods: A retrospective analysis was conducted of prospectively collected data from Tabriz Medical Trauma Center. Our aim was to perform surgical revascularization as soon as the arterial injury was recognized. The mechanism of injury was blunt in the entire cohort of patients, and all of them had bone fractures about the knee. The treatment of arterial injury included vein graft interposition in 39 (63%), primary anastomosis in 20 (32.3%), and lateral repair in 3 (4.8%) patients. The patients were divided into 2 study groups: limb salvage group (group 1) and amputation group (group 2). Subgroup analysis consisted of univariate analysis comparing the 2 groups and multivariate analysis examining the factors associated negatively and positively with the primary endpoint, limb salvage. Results: In the entire cohort of patients, 60 patients (97%) were male and 2 were female (3%); the mean age was 34.1 years (16–49 years). The overall amputation rate in this study was 37.1% (23 amputations). Significant (P < 0.05) independent factors associated negatively with limb salvage were combined tibia and fibula fracture, concomitant artery and vein injury, ligation of venous injury, and lack of backflow after Fogarty catheter thrombectomy, while repair of popliteal artery and vein injury, when present, was associated with improved early limb salvage. For 40 patients, we adopt a liberal attitude toward open 4-compartment fasciotomy through both medially and laterally placed incisions. Conclusion: Expeditious recognition of vascular injury, transport to repair, and repair of associated venous injury when possible are necessary to optimize limb salvage. The importance of a high level of suspicion and low threshold for timely amputation has been emphasized

  13. Clinical Outcomes and Risks of Single-stage Bilateral Unicompartmental Knee Arthroplasty via Oxford Phase III

    PubMed Central

    Ma, Tong; Tu, Yi-Hui; Xue, Hua-Ming; Wen, Tao; Cai, Min-Wei

    2015-01-01

    Background: Osteoarthritis often affects the joint bilaterally, and the single-stage (SS) unicompartmental knee arthroplasty (UKA) is advantageous in terms of a single anesthesia administration, a short hospital stay, lower medical costs, and enhanced patient convenience. However, the complication risk of SS UKA continues to be debated. The aim of this article was to evaluate the clinical effectiveness, complications, and functional recovery of SS and two-stage (TS) UKA. Methods: From January 2008 to December 2013, we compared a series of 36 SS UKA with 45 TS UKA for osteoarthritis. The mean age was 65.4 years (range: 55–75 years). The mean body mass index was 25.2 kg/m2 (range: 22–29 kg/m2). The pre- and post-operative Oxford Knee Scores (OKSs), complications, operative times, tourniquet times, the amount of drainage, and hemoglobin (Hb) were evaluated. The Chi-square test, Fisher's exact test, and paired and grouped t-tests were used in this study. Results: The mean follow-up was 50 months. No complications of death, fat embolism, deep vein thrombosis, and prosthetic infection were reported. Patients who underwent SS UKA had a shorter cumulative anesthesia time (113.5 vs. 133.0 min, P < 0.01). There were no significant variations between the values of the mean tourniquet time, the amount of drainage, pre- and post-operative Hb in the different groups. No patient required a blood transfusion. No statistical differences were found in the complications between two groups (P > 0.05). At the final follow-up, the mean OKS improved from 39.48 ± 5.69 to 18.83 ± 3.82 (P < 0.01), with no statistical differences between the two groups (P > 0.05). Patients who underwent SS UKA had a faster recovery. Conclusions: The single-staged UKA offers the benefits of a single anesthesia administration, reduced total anesthetic time, decreased overall rehabilitation time, and absence of an increase in perioperative mortality or complications compared with the TS bilateral UKA

  14. [Oral glucocorticoid-induced psychiatric side-effects: focus on clinical specificities, incidence, risk factors and treatment].

    PubMed

    Ricoux, A; Guitteny-Collas, M; Sauvaget, A; Delvot, P; Pottier, P; Hamidou, M; Vanelle, J-M

    2013-05-01

    Oral glucocorticoids have been used for several decades and psychiatric side-effects may occur. This review will discuss relevant data of the clinical specificities, the incidence, the risk factors for the occurrence of these episodes and the preventive and curative medications of these episodes. We performed a literature review by using PubMed database. We selected and discussed articles and studies with high standard of evidence. The occurrence of psychiatric symptoms is quite frequent. The varying intensity of clinical features ranges from minor signs (impregnation) to acute psychotic episodes which may occur from 5 to 30% of patients. Affective symptoms or disorders are the most prominent clinical features. Delirium may occur and suicidal risk could be increased. The significant predictive factors are prednisone dosage more than 40 mg/day, particularly weight-based dosage, and a history of psychiatric disorders. When a reduced dosage of glucocorticoids is not sufficient to control the symptomatology, curative medication is mainly based on atypical antipsychotics such as olanzapine. Studies about neuropsychiatric complications of glucocorticoids present various and heterogeneous results. Further prospective clinical studies should be based on a close cooperation between physicians and consultation liaison psychiatrists. This collaboration is required for an optimized management of the patient who receive glucocorticoids. PMID:23374903

  15. A Pilot Study of Reasons and Risk Factors for "No-Shows" in a Pediatric Neurology Clinic.

    PubMed

    Guzek, Lindsay M; Fadel, William F; Golomb, Meredith R

    2015-09-01

    Missed clinic appointments lead to decreased patient access, worse patient outcomes, and increased healthcare costs. The goal of this pilot study was to identify reasons for and risk factors associated with missed pediatric neurology outpatient appointments ("no-shows"). This was a prospective cohort study of patients scheduled for 1 week of clinic. Data on patient clinical and demographic information were collected by record review; data on reasons for missed appointments were collected by phone interviews. Univariate and multivariate analyses were conducted using chi-square tests and multiple logistic regression to assess risk factors for missed appointments. Fifty-nine (25%) of 236 scheduled patients were no-shows. Scheduling conflicts (25.9%) and forgetting (20.4%) were the most common reasons for missed appointments. When controlling for confounding factors in the logistic regression, Medicaid (odds ratio 2.36), distance from clinic, and time since appointment was scheduled were associated with missed appointments. Further work in this area is needed. PMID:25503257

  16. Clinical Implications in the Treatment of Mania: Reducing Risk Behavior in Manic Patients

    ERIC Educational Resources Information Center

    Leahy, Robert L.

    2005-01-01

    Bipolar individuals engage in risky behavior during manic phases that contributes to their vulnerability to regret during their depressive phases. A cognitive model of risk assessment is proposed in which manic risk assessment is based on exaggeration of current and future resources, high utility for gains, low demands for information to assess…

  17. 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

  18. 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

  19. 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.

  20. Risk management in clinical practice. Part 6b. Identifying and avoiding medico-legal risks in removable dentures.

    PubMed

    Stilwell, C

    2010-10-01

    The most likely cause of complaint with prosthodontics is a denture that in some way fails to be accepted. A denture that does not perform as the patient expects can give rise to great disappointment and anger. The problem is that acceptance of a denture is not just a technical issue. Success depends on the individual's ability to tolerate and adapt to the denture. It is therefore essential to make the right assessment for the patient from the outset. This includes discovering the patient's priorities and establishing realistic expectations. With the aim of assisting the dental profession in identifying and avoiding medico-legal risks in removable dentures, this article sets out a systematic, diagnostic and collaborative approach to complete and partial denture assessment and treatment. PMID:20930774

  1. Cardiovascular risk across the histological spectrum and the clinical manifestations of non-alcoholic fatty liver disease: An update

    PubMed Central

    Athyros, Vasilios G; Tziomalos, Konstantinos; Katsiki, Niki; Doumas, Michael; Karagiannis, Asterios; Mikhailidis, Dimitri P

    2015-01-01

    Non-alcoholic fatty liver disease (NAFLD) is considered to be an independent cardiovascular disease (CVD) risk factor. However, simple steatosis has a benign clinical course without excess mortality. In contrast, the advanced form of NAFLD, non-alcoholic steatohepatitis (NASH) with liver fibrosis increases mortality by approximately 70%, due to an increase in CVD mortality by approximately 300%. Chronic kidney disease (CKD) may be caused by NAFLD/NASH and it substantially increases CVD risk, especially in the presence of type 2 diabetes mellitus. Moreover, CKD may trigger NAFLD/NASH deterioration in a vicious cycle. NAFLD/NASH is also related to increased arterial stiffness (AS), an independent CVD risk factor that further raises CVD risk. Diagnosis of advanced liver fibrosis (mainly by simple non-invasive tests), CKD, and increased AS should be made early in the course of NAFLD and treated appropriately. Lifestyle measures and statin treatment may help resolve NAFLD/NASH and beneficially affect the CVD risk factors mentioned above. PMID:26078558

  2. Management of patients with chronic lymphocytic leukemia with a high risk of adverse outcome: the Mayo Clinic approach

    PubMed Central

    ZENT, CLIVE S.; KAY, NEIL E.

    2012-01-01

    Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) is usually an incidental diagnosis in patients with early–intermediate stage disease. However, most patients with a diagnosis of CLL will subsequently have significant morbidity and die from their disease and its complications. For these patients, CLL is not the ‘good leukemia’ with a predictably ‘benign’ outcome. Indeed, we can now identify a cohort of patients with high-risk CLL at diagnosis who will have rapid disease progression, poor response to treatment, and poor survival based on prognostic methods developed from an improved understanding of the biology of CLL. The concomitant development of improved treatments has led to risk-adjusted management approaches that could improve outcomes. We discuss the clinical and laboratory components of comprehensive risk evaluation of patients with CLL and our approach to the management of patients with a high to very high risk of disease progression and poor outcome. In addition, we review the challenges and prospects for improving prognostic precision and the development of new drugs to improve the treatment of patients with CLL with a high risk of adverse outcome. PMID:21649549

  3. Integrating risk minimization planning throughout the clinical development and commercialization lifecycle: an opinion on how drug development could be improved.

    PubMed

    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

  4. 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

  5. Cardiovascular risk assessment in diabetes mellitus: comparison of the general Framingham risk profile versus the World Health Organization/International Society of Hypertension risk prediction charts in Arabs--clinical implications.

    PubMed

    Al-Lawati, Jawad A; Barakat, Mohammed N; Al-Lawati, Najla A; Al-Maskari, Masoud Y; Elsayed, Medhat K; Mikhailidis, Dimitri P; Al-Zakwani, Ibrahim S

    2013-07-01

    We estimated the prevalence of cardiovascular disease (CVD) risk and its clinical implications among 1 110 Omani patients with type 2 diabetes mellitus (DM) using 2 different CVD risk tools: the general Framingham risk profile (GFRP) and the joint World Health Organization/International Society of Hypertension (WHO/ISH) risk prediction charts. The GFRP tool identified higher proportion of patients compared with joint WHO/ISH tool at 10-year CVD risk 10% to <20% and at 20% to <30%. At CVD risk ≥30%, both assessment tools identified similar proportions of patients (22% vs 24%; P=.120). Compared with WHO/ISH charts, the GFRP identified almost double the number of men eligible for aspirin treatment at CVD risk thresholds of ≥10% (86% vs 43%). In women, the proportions were, 66% and 45%, respectively. For statins, the figures were, 60% and 37%, for men and 28% and 36%, for women. In conclusion, the GFRP overestimates the number of patients eligible for primary prevention of CVD compared with the joint WHO/ISH method. PMID:22942129

  6. 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

  7. Methods Used in Internal Industry Clinical Trials to Assess Tobacco Risk Reduction

    PubMed Central

    Rees, Vaughan W.; Kreslake, Jennifer M.; O’Connor, Richard J.; Cummings, K. Michael; Parascandola, Mark; Hatsukami, Dorothy; Shields, Peter G.; Connolly, Gregory N.

    2009-01-01

    Objective Methods to assess reduced exposure products should include those which aid in determining likely patterns of human use and exposure. Tobacco industry clinical trial methods may provide insight into strategies to assess potential reduced exposure products (PREPs) for public health purposes. Internal tobacco industry documents detailing human clinical research with PREPs were examined to document major research strategies used and identify potentially fruitful methods not currently used in the mainstream arena. Methods Primary data were obtained from records of research conducted internally by tobacco companies and affiliated researchers, and included manuscript drafts, presentations, protocols, and instruments relating to internal clinical trials of human tobacco use and exposure. Results Tobacco industry clinical research has focused on reduced exposure products, most notably Premier, Accord and Eclipse. The most widely used strategy observed was switching studies, and details of study designs and protocols favored by the industry are described. Key measures include biomarkers of exposure (e.g. cotinine, CO and specific carcinogens), and acute health effects such as physical health and fitness. Conclusions Tobacco industry clinical research has used relatively standard switching study methods, but with a broad set of measures. Clinical switching studies have been conducted by the industry primarily to support existing claims or to develop new claims. Knowledge of prior industry activity can guide and inform future public health research efforts. While industry clinical trial methods are comparable to current mainstream methods, limited information about the validity of outcome measures used limit their viability for immediate adoption in mainstream science. PMID:19959673

  8. Anticipating risk for human subjects participating in clinical research: application of Failure Mode and Effects Analysis.

    PubMed

    Cody, Robert J

    2006-03-01

    Failure Mode and Effects Analysis (FMEA) is a method applied in various industries to anticipate and mitigate risk. This methodology can be more systematically applied to the protection of human subjects in research. The purpose of FMEA is simple: prevent problems before they occur. By applying FMEA process analysis to the elements of a specific research protocol, the failure severity, occurrence, and detection rates can be estimated for calculation of a "risk priority number" (RPN). Methods can then be identified to reduce the RPN to levels where the risk/benefit ratio favors human subject benefit, to a greater magnitude than existed in the pre-analysis risk profile. At the very least, the approach provides a checklist of issues that can be individualized for specific research protocols or human subject populations. PMID:16537191

  9. [Prevention of cleft lip and palate. Reducing risk of recurrence--a 25-year clinical experience].

    PubMed

    Schubert, Johannes; Krost, Birgit

    2006-09-01

    From 1980 to 2005, 71 female patients having non-syndromic cleft lip and palate (CLP) or cleft palate (CP) themselves or in their family and desiring to have children underwent 88 times a cleft prevention protocol with high doses of Vitamin B Complex and Actovegin twice a week. The data about the outcome of the pregnancy were prospectively collected. Empiric data of the recurrence risks from the literature depending on the cleft type were used as comparative group. In 80 cases, a healthy child was born. In two cases microsymptoms of unilateral lip notches were observed. The observed risks with prophylaxis were 2.9% (only microsymptoms!) and 0% comparing with 4.9% and 2.4% respectively in the controls. The relative risk as reference value between expected and observed risk was 0.6 (microsymptoms) for CLP and 0 for CP. PMID:16944083

  10. How Good is Our Best Guess? Clinical Application of the WHO FRAX Tool in Osteoporotic Fracture Risk Determination and Treatment Decisions.

    PubMed

    Hinz, Laura; Freiheit, Elizabeth; Kline, Gregory

    2016-08-01

    Historically, treatment decisions for osteoporosis were based on bone mineral density. However, many fractures occur in patients with T-scores outside the osteoporotic range, emphasizing the importance of multi-factorial risk assessments. The World Health Organization Fracture Risk Assessment Tool (FRAX) predicts 10-year risk of osteoporotic fracture. We hypothesized that physicians' clinical estimates of osteoporotic fracture risk would differ significantly from that calculated by FRAX. Thus, treatment decisions would differ depending whether or not physicians used FRAX. A survey consisting of five clinical scenarios was administered to 76 endocrinologists, family physicians, internists, and internal medicine residents. They were asked to estimate the osteoporotic fracture risk and decide whether they would offer preventative treatment. Their estimates were compared to the risk predicted by FRAX and national treatment threshold guidelines. The primary outcome was the difference between the participant's estimate and the FRAX-based estimate of the 10-year risk of osteoporotic fracture for each scenario. In each scenario, physicians statistically significantly over-estimated fracture risk compared to that predicted by FRAX. Estimates for hip fracture risk were 2-4 times higher than FRAX estimates. The major osteoporotic fracture risk at which participants would offer treatment varied with physician group, with endocrinologists, family physicians, and residents requiring a 10-20 % 10-year risk, while internal medicine physician thresholds ranged from 2 to 20 %. Physicians greatly over-estimated the risk of hip fracture based on clinical information. FRAX is necessary to accurately quantify risk, but because physicians varied in the level of risk required before they would offer treatment, uniform approaches to risk estimation may still not result in uniform clinical treatment decisions. PMID:27038319

  11. 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

  12. 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

  13. 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

  14. Fertility drug use and risk of ovarian tumors: a debated clinical challenge.

    PubMed

    Gadducci, Angiolo; Guerrieri, Maria Elena; Genazzani, Andrea Riccardo

    2013-01-01

    Infertility itself increases the incidence of ovarian carcinoma, while the potential additional risk associated with the use of fertility drugs is still debated. In 1992, the cumulative analysis of 12 US case-control studies revealed that women who received ovulation-inducing drugs had approximately three-fold higher incidence of invasive ovarian carcinoma. Other investigations reported a lower increase of the risk of invasive carcinoma or borderline tumor of the ovary in women treated with these agents. Conversely, several other case-control or cohort studies failed to detect a significant correlation between fertility drug use and ovarian tumor risk in either parous or nulliparous women compared with untreated infertile women. Moreover neither the number of treatment cycles nor the type of drug used was associated with an increased risk in most studies. Incessant ovulation and excessive gonadotropin secretion have been long considered to play a major role in the development of ovarian carcinoma, and therefore fertility drugs, which raise the serum levels of gonadotropins and increase the chances of multiple ovulations, have been retained as a risk factor for this malignancy, However, the large majority of literature data as well as the new hypotheses on ovarian carcinogenesis appear to exclude a relevant impact of fertility drug use on the risk of ovarian tumors, and especially of high-grade invasive epithelial ovarian cancers. PMID:22946709

  15. Attitudes and beliefs regarding depression, HIV/AIDS and HIV risk-related sexual behaviors among clinically depressed African American adolescent females

    PubMed Central

    Brawner, Bridgette M.

    2012-01-01

    Individuals’ attitudes and beliefs toward behaviors are key indicators of behavioral performance. The purpose of this study was to elucidate attitudes and beliefs about depression, HIV/AIDS and HIV risk-related sexual behaviors among clinically depressed African American adolescent females and to develop an understanding of their context for HIV risk. For this descriptive qualitative inquiry, semi-structured interviews and surveys were employed (N = 24). The narratives reveal that behavioral sequelae of depression (i.e. loneliness) can produce risk for HIV. These findings may guide psychiatric nurse educators, scientists, and practitioners to modify HIV risk among clinically depressed African American adolescent females. PMID:23164403

  16. Attitudes and beliefs regarding depression, HIV/AIDS, and HIV risk-related sexual behaviors among clinically depressed African American adolescent females.

    PubMed

    Brawner, Bridgette M

    2012-12-01

    Individuals' attitudes and beliefs toward behaviors are key indicators of behavioral performance. The purposes of this study were to elucidate attitudes and beliefs about depression, HIV/AIDS, and HIV risk-related sexual behaviors among clinically depressed African American adolescent females and to develop an understanding of their context for HIV risk. For this descriptive qualitative inquiry, semistructured interviews and surveys were employed (N = 24). The narratives reveal that behavioral sequelae of depression (i.e., loneliness) can produce risk for HIV. These findings may guide psychiatric nurse educators, scientists, and practitioners to modify HIV risk among clinically depressed African American adolescent females. PMID:23164403

  17. 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.

  18. 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.

  19. Risk of Diabetes among Patients Receiving Primary Androgen Deprivation Therapy for Clinically Localized Prostate Cancer

    PubMed Central

    Tsai, Huei-Ting; Keating, Nancy L.; Van Den Eeden, Stephen K.; Haque, Reina; Cassidy-Bushrow, Andrea E.; Yood, Marianne Ulcickas; Smith, Matthew R.; Potosky, Arnold L.

    2015-01-01

    Purpose Androgen deprivation therapy may increase diabetes risk. As the benefits of primary androgen deprivation therapy for localized prostate cancer are controversial, and most prostate cancer survivors are of advanced age with comorbidities, it is important to determine if primary androgen deprivation therapy increases the risk of diabetes and to determine the susceptibility factors. Materials and Methods We conducted a retrospective cohort study of 12,191 men diagnosed with incident localized prostate cancer during 1995 to 2008, age 35 to 100 years, and without diabetes or receipt of prostatectomy or radiation 1 year after diagnosis. Patients were enrolled in 1 of 3 managed health plans and followed through 2010. Primary androgen deprivation therapy was defined as androgen deprivation therapy within 1 year after diagnosis. Incident diabetes was ascertained using inpatient and outpatient diagnosis codes, diabetes medications and hemoglobin A1c values. We estimated primary androgen deprivation therapy associated diabetes risk using Cox proportional hazard models in conventional and propensity score analyses. Results Diabetes developed in 1,203 (9.9%) patients during followup (median 4.8 years) with incidence rates of 2.5 and 1.6 events per 100 person-years in the primary androgen deprivation therapy and nonprimary androgen deprivation therapy groups, respectively. Primary androgen deprivation therapy was associated with a 1.61-fold increased diabetes risk (95% CI 1.38–1.88). The number needed to harm was 29. The association was stronger in men age 70 or younger than in older men (HR 2.25 vs 1.40, p value for interaction = 0.008). Conclusions Primary androgen deprivation therapy may increase diabetes risk by 60% and should be used with caution when managing localized prostate cancer. Because of the consistent association between androgen deprivation therapy and greater diabetes risk across disease states, we recommend routine screening and lifestyle

  20. Is Diabetes a Risk Factor for a Severe Clinical Presentation of Dengue? - Review and Meta-analysis

    PubMed Central

    Htun, Nan Shwe Nwe; Odermatt, Peter; Eze, Ikenna C.; Boillat-Blanco, Noémie; D’Acremont, Valérie; Probst-Hensch, Nicole

    2015-01-01

    Background The mean age of acute dengue has undergone a shift towards older ages. This fact points towards the relevance of assessing the influence of age-related comorbidities, such as diabetes, on the clinical presentation of dengue episodes. Identification of factors associated with a severe presentation is of high relevance, because timely treatment is the most important intervention to avert complications and death. This review summarizes and evaluates the published evidence on the association between diabetes and the risk of a severe clinical presentation of dengue. Methodology/Findings A systematic literature review was conducted using the MEDLINE database to access any relevant association between dengue and diabetes. Five case-control studies (4 hospital-based, 1 population-based) compared the prevalence of diabetes (self-reported or abstracted from medical records) of persons with dengue (acute or past; controls) and patients with severe clinical manifestations. All except one study were conducted before 2009 and all studies collected information towards WHO 1997 classification system. The reported odds ratios were formally summarized by random-effects meta-analyses. A diagnosis of diabetes was associated with an increased risk for a severe clinical presentation of dengue (OR 1.75; 95% CI: 1.08–2.84, p = 0.022). Conclusions/Significance Large prospective studies that systematically and objectively obtain relevant signs and symptoms of dengue fever episodes as well as of hyperglycemia in the past, and at the time of dengue diagnosis, are needed to properly address the effect of diabetes on the clinical presentation of an acute dengue fever episode. The currently available epidemiological evidence is very limited and only suggestive. The increasing global prevalence of both dengue and diabetes justifies further studies. At this point, confirmation of dengue infection as early as possible in diabetes patients with fever if living in dengue endemic regions

  1. Re-irradiation of recurrent medulloblastoma: does clinical benefit outweigh risk for toxicity?

    PubMed Central

    Wetmore, Cynthia; Herington, Danielle; Lin, Tong; Onar-Thomas, Arzu; Gajjar, Amar; Merchant, Thomas E.

    2015-01-01

    Purpose Patients with recurrent medulloblastoma (MB) have a dismal prognosis. There has been a reluctance to use radiation in the salvage therapy regimens for these patients because of concerns about toxicity and unknown efficacy. Comparing survival outcomes and toxicities in relapsed patients treated with and without radiation may help define its role. Methods and Materials A retrospective review was conducted that included 38 patients with recurrent MB treated with similar risk-adapted therapy at initial diagnosis; re-irradiation was a component of salvage therapy in 14. Overall survival (OS) and toxicity were evaluated according to the use of radiation, prior risk stratification and other factors. Results For relapsed standard risk patients, the use of additional irradiation resulted in a statistically significant improvement in OS from initial diagnosis (p=0.036) where 5- and 10-year OS rates were 55% ± 14% vs. 33% ± 16% and 46% ± 14% vs. 0%, respectively for re-irradiated patients vs. others. A similar improvement was observed in high risk (p=0.003) patients. There was an association between the use of additional irradiation and an increased rate of necrosis as determined by neuroimaging (p=0.0468). Conclusion The use of irradiation as a component of salvage therapy for relapsed MB may prolong survival. The benefit appears to be greatest for relapsed standard risk patients. PMID:25080363

  2. 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

  3. Clinical relevance of 8q23, 15q13 and 18q21 SNP genotyping to evaluate colorectal cancer risk.

    PubMed

    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 χ(2) 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

  4. 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

  5. Aggression in borderline personality disorder: evidence for increased risk and clinical predictors.

    PubMed

    Allen, Albert; Links, Paul S

    2012-02-01

    This article aimed to systematically review the current literature regarding elevated risk of aggression in borderline personality disorder (BPD) and to review factors that differentiate aggressive from nonaggressive individuals with BPD. It has done so via a systematic review of the literature using Ovid MEDLINE and PsycINFO from 1980 to June 2010. Results indicate that BPD does not appear to be independently associated with increased risk of violence in the general population. History of childhood maltreatment, history of violence or criminality, and comorbid psychopathy or antisocial personality disorder appear to be predictors of violence in patients with BPD. This review concludes that the current evidence suggests that patients with BPD are not more violent than individuals in the general population. More studies are needed on factors that predict risk of aggression at an individual level. PMID:22033830

  6. 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

  7. A Randomized Trial of Family Focused Therapy With Populations at Clinical High Risk for Psychosis: Effects on Interactional Behavior

    PubMed Central

    O’Brien, Mary P.; Miklowitz, David J.; Candan, Kristin A.; Marshall, Catherine; Domingues, Isabel; Walsh, Barbara C.; Zinberg, Jamie L.; De Silva, Sandra D.; Woodberry, Kristen A.; Cannon, Tyrone D.

    2013-01-01

    Objective This study investigated whether family focused therapy (FFT-CHR), an 18-session intervention that consisted of psychoeducation and training in communication and problem solving, brought about greater improvements in family communication than enhanced care (EC), a 3-session psychoeducational intervention, among individuals at clinical high risk for developing psychosis. Method This study was conducted within a randomized controlled trial across 8 sites. We examined 10-min problem-solving discussions at baseline and 6-month reassessment among 66 adolescents and young adults and their parents. Trained coders who were blind to treatment and time of assessment achieved high levels of interrater reliability when evaluating family discussions on categories of calm–constructive and critical– conflictual behavior. Results Individuals at high risk and their family members who participated in FFT-CHR demonstrated greater improvement from baseline to 6-month reassessment in constructive communication and decreases in conflictual behaviors during family interactions than those in EC. Participants in FFT-CHR showed greater increases from baseline to 6 months in active listening and calm communication and greater decreases in irritability and anger, complaints and criticism, and off-task comments compared to participants in EC. These changes occurred equally in high-risk participants and their family members. Conclusions A 6-month family skills training treatment can bring about significant improvement in family communication among individuals at high risk for psychosis and their parents. Future studies should examine the association between enhancements in family communication and reduced risk for the onset of psychosis among individuals at high risk. PMID:24188511

  8. Genetic Variants in Matrix Metalloproteinase Genes as Disposition Factors for Ovarian Cancer Risk, Survival, and Clinical Outcome

    PubMed Central

    Wang, Yan; Ye, Yuanqing; Lin, Jie; Meyer, Larissa; Wu, Xifeng; Lu, Karen; Liang, Dong

    2016-01-01

    Ovarian cancer is one of the leading female cancers in the United States. Challenges remain in early diagnosis of this deadly disease. Matrix metalloproteinases (MMPs) family genes are paradoxically involved in cancer promotion and suppression. We hypothesize that genetic variants in MMP genes are associated with ovarian cancer development, so they could be potential markers for ovarian cancer diagnosis and prognosis. In this study of 417 ovarian cancer cases and 417 healthy controls, we genotyped a comprehensive panel of 266 single nucleotide polymorphisms (SNPs) in 23 MMP genes and analysed their associations with ovarian cancer risk, overall survival and treatment response in ovarian cancer cases who received platinum-based chemotherapy with surgery. In the analysis on 339 Caucasian cases and 349 Caucasian controls, 4 SNPs were significantly associated with cancer risk. The most significant association was observed for rs2292730 (OR = 2.03, 95% CI = 1.39–2.96, P = 0.0002). Classification and regression tree analysis identified four terminal nodes with differential risk of ovarian cancer. Thirty-four SNPs were significantly associated with overall survival and four of which showed significant association with response to chemotherapy. Unfavourable genotype analysis of top SNPs on overall risk of death showed significant gene-dosage effect, survival tree analysis differentiated patients into distinct risk groups based on their genetic profiles with median survival times (MSTs) ranging from 17.7 to 151.7 months. In conclusion, our results suggest that genetic variants in MMP pathway genes may modulate the risk and clinical outcomes of ovarian cancer, both individually and jointly. PMID:25867973

  9. Genetic variants in matrix metalloproteinase genes as disposition factors for ovarian cancer risk, survival, and clinical outcome.

    PubMed

    Wang, Yan; Ye, Yuanqing; Lin, Jie; Meyer, Larissa; Wu, Xifeng; Lu, Karen; Liang, Dong

    2015-06-01

    Ovarian cancer is one of the leading female cancers in the United States. Challenges remain in early diagnosis of this deadly disease. Matrix metalloproteinases (MMPs) family genes are paradoxically involved in cancer promotion and suppression. We hypothesize that genetic variants in MMP genes are associated with ovarian cancer development, so they could be potential markers for ovarian cancer diagnosis and prognosis. In this study of 417 ovarian cancer cases and 417 healthy controls, we genotyped a comprehensive panel of 266 single nucleotide polymorphisms (SNPs) in 23 MMP genes and analysed their associations with ovarian cancer risk, overall survival and treatment response in ovarian cancer cases who received platinum-based chemotherapy with surgery. In the analysis on 339 Caucasian cases and 349 Caucasian controls, 4 SNPs were significantly associated with cancer risk. The most significant association was observed for rs2292730 (OR = 2.03, 95% CI = 1.39-2.96, P = 0.0002). Classification and regression tree analysis identified four terminal nodes with differential risk of ovarian cancer. Thirty-four SNPs were significantly associated with overall survival and four of which showed significant association with response to chemotherapy. Unfavourable genotype analysis of top SNPs on overall risk of death showed significant gene-dosage effect, survival tree analysis differentiated patients into distinct risk groups based on their genetic profiles with median survival times (MSTs) ranging from 17.7 to 151.7 months. In conclusion, our results suggest that genetic variants in MMP pathway genes may modulate the risk and clinical outcomes of ovarian cancer, both individually and jointly. PMID:25867973

  10. Clinical orofacial characteristics associated with risk of first-onset TMD: the OPPERA prospective cohort study

    PubMed Central

    Ohrbach, Richard; Bair, Eric; Fillingim, Roger B.; Gonzalez, Yoly; Gordon, Sharon M.; Lim, Pei-Feng; Ribeiro-Dasilva, Margarete; Diatchenko, Luda; Dubner, Ron; Greenspan, Joel D.; Knott, Charles; Maixner, William; Smith, Shad; Slade, Gary

    2013-01-01

    Case-control studies have documented clinical manifestations of chronic temporomandibular disorders (TMD), whereas clinical predictors of TMD development are largely unknown. We evaluated 41 clinical orofacial characteristics thought to predict first-onset TMD in a prospective cohort study of U.S. adults aged 18-44 years. During the median 2.8-year follow-up period, 2,737 people completed quarterly screening questionnaires. Those reporting symptoms were examined and 260 people were identified with first-onset TMD. Univariate and multivariate Cox regression models quantified associations between baseline clinical orofacial measures and TMD incidence. Significant predictors from baseline self-report instruments included oral parafunctions, prior facial pain and its life-impact, TMJ noises and jaw locking, and non-specific orofacial symptoms. Significant predictors from the baseline clinical examination were pain on jaw opening and pain from palpation of masticatory, neck, and body muscles. Examiner assessments of TMJ noise and tooth wear facets did not predict incidence. In multivariate analysis, non-specific orofacial symptoms, pain from jaw opening and oral parafunctions predicted TMD incidence. The results indicate that only a few orofacial examination findings influenced TMD incidence, and only to a modest degree. More pronounced influences were found for self-reported symptoms, particularly those that appeared to reflect alterations to systems beyond the masticatory tissues. PMID:24275222

  11. Increased peripheral blood CD5+ B cells predict earlier conversion to MS in high-risk clinically isolated syndromes.

    PubMed

    Villar, Luisa M; Espiño, Mercedes; Roldán, Ernesto; Marín, Nieves; Costa-Frossard, Lucienne; Muriel, Alfonso; Alvarez-Cermeño, José C

    2011-06-01

    Clinically isolated syndrome patients (CIS) with oligoclonal IgG bands (OCGB) are at high risk for clinically definite multiple sclerosis (MS). However, the outcome for individual patients is unpredictable and the search for reliable blood markers predicting early conversion to multiple sclerosis (MS) has clinical relevance. CD5+ B cells (CD5+Bc) are involved in some autoimmune diseases. This study investigated whether high blood CD5+Bc percentage can predict CIS conversion to MS. Fifty-five consecutive CIS showing OCGB were prospectively studied. Every patient underwent a brain MRI study and a flow cytometry analysis of CD5+Bc percentage. Conversion to MS was studied during follow-up. The CD5+Bc percentage was assessed in 40 controls and a cut-off value of 3.5% (mean+2 SD) was calculated. A blood CD5+Bc percentage above this value predicted earlier conversion to MS in the whole group (hazard ratio [HR]: 3.40; 95% confidence interval [CI]: 1.69-6.68; p=0.0005) and in CIS patients fulfilling three or more Barkhof-Tintoré criteria plus OCGB, who showed higher risk for MS (HR: 3.79; 95% CI: 1.86-15.32; p=0.0018). Multivariate analysis also showed a predictive value for high blood CD5+Bc count (HR: 4.3; 95% CI: 1.9-9.5; p<0.0001). It was concluded that high percentages of CD5+Bc independently associate with increased risk of early conversion to MS in CIS patients with OCGB and Barkhof-Tintoré criteria. PMID:21436320

  12. IDO1 and IDO2 Non-Synonymous Gene Variants: Correlation with Crohn's Disease Risk and Clinical Phenotype

    PubMed Central

    Zhang, Yuanhao; Sayuk, Gregory S.; Li, Ellen; Ciorba, Matthew A.

    2014-01-01

    Background Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. Genetic polymorphisms can confer CD risk and influence disease phenotype. Indoleamine 2,3 dioxygenase-1 (IDO1) is one of the most over-expressed genes in CD and mediates potent anti-inflammatory effects via tryptophan metabolism along the kynurenine pathway. We aimed to determine whether non-synonymous polymorphisms in IDO1 or IDO2 (a gene paralog) are important either as CD risk alleles or as modifiers of CD phenotype. Methods Utilizing a prospectively collected database, clinically phenotyped CD patients (n = 734) and non-IBD controls (n = 354) were genotyped for established IDO1 and IDO2 non-synonymous single nucleotide polymorphisms (SNPs) and novel genetic variants elucidated in the literature. Allelic frequencies between CD and non-IBD controls were compared. Genotype-phenotype analysis was conducted. IDO1 enzyme activity was assessed by calculating the serum kynurenine to tryptophan ratio (K/T). Results IDO1 SNPs were rare (1.7% non-IBD vs 1.1% CD; p = NS) and not linked to Crohn's disease diagnosis in this population. IDO1 SNPs did however associate with a severe clinical course, presence of perianal disease, extraintestinal manifestations and a reduced serum K/T ratio during active disease suggesting lower IDO1 function. IDO2 minor allele variants were common and one of them, rs45003083, associated with reduced risk of Crohn's disease (p = 0.025). No IDO2 SNPs associated with a particular Crohn's disease clinical phenotype. Conclusions This work highlights the functional importance of IDO enzymes in human Crohn's disease and establishes relative rates of IDO genetic variants in a US population. PMID:25541686

  13. Clinical Features of and Risk Factors for Fatal Ebola Virus Disease, Moyamba District, Sierra Leone, December 2014-February 2015.

    PubMed

    Haaskjold, Yngvar Lunde; Bolkan, Håkon Angell; Krogh, Kurt Østhuus; Jongopi, James; Lundeby, Karen Marie; Mellesmo, Sindre; Garcés, Pedro San José; Jøsendal, Ola; Øpstad, Åsmund; Svensen, Erling; Fuentes, Luis Matias Zabala; Kamara, Alfred Sandy; Riera, Melchor; Arranz, Javier; Roberts, David P; Stamper, Paul D; Austin, Paula; Moosa, Alfredo J; Marke, Dennis; Hassan, Shoaib; Eide, Geir Egil; Berg, Åse; Blomberg, Bjørn

    2016-09-01

    The 2013-2016 outbreak of Ebola virus disease (EVD) in West Africa infected >28,000 people, including >11,000 who died, and disrupted social life in the region. We retrospectively studied clinical signs and symptoms and risk factors for fatal outcome among 31 Ebola virus-positive patients admitted to the Ebola Treatment Center in Moyamba District, Sierra Leone. We found a higher rate of bleeding manifestations than reported elsewhere during the outbreak. Significant predictors for death were shorter time from symptom onset to admission, male sex, high viral load on initial laboratory testing, severe pain, diarrhea, bloody feces, and development of other bleeding manifestations during hospitalization. These risk factors for death could be used to identify patients in need of more intensive medical support. The lack of fever in as many as one third of EVD cases may have implications for temperature-screening practices and case definitions. PMID:27268303

  14. 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

  15. Gaining control over breast cancer risk: Transforming vulnerability, uncertainty, and the future through clinical trial participation - a qualitative study.

    PubMed

    Holmberg, Christine; Whitehouse, Katie; Daly, Mary; McCaskill-Stevens, Worta

    2015-11-01

    Concepts of disease risk and its management are central to processes of medicalisation and pharmaceuticalisation. Through a narrative perspective, this paper aims to understand how such macro-level developments may (or may not) be experienced individually, and how an algorithm that is used for recruitment into a clinical trial may structure individual notions of being 'at risk' and 'in need of treatment'. We interviewed 31 women participating in the Study of Tamoxifen and Raloxifene (STAR), a chemoprevention trial conducted in the US between 1999 and 2006. Interviews were thematically analysed. Women in the study had experienced the threat of breast cancer and felt vulnerable to developing the disease prior to STAR participation. The diagnosis of 'being at risk' for cancer through an algorithm that determined risk-eligibility for STAR, opened up the possibility for the women to heal. The trial became a means to recognise and collectivise the women's experiences of vulnerability. Through medication intake, being cared for by study coordinators, and the sense of community with other STAR participants, trial participation worked to transform women's lives. Such transformative experiences may nevertheless have been temporary, enduring only as long as the close links to the medical institution through trial participation lasted. PMID:26235092

  16. Uptake of tamoxifen in consecutive premenopausal women under surveillance in a high-risk breast cancer clinic

    PubMed Central

    Donnelly, L S; Evans, D G; Wiseman, J; Fox, J; Greenhalgh, R; Affen, J; Juraskova, I; Stavrinos, P; Dawe, S; Cuzick, J; Howell, A

    2014-01-01

    Background: Randomised trials of tamoxifen versus placebo indicate that tamoxifen reduces breast cancer risk by approximately 33%, yet uptake is low. Approximately 10% of women in our clinic entered the IBIS-I prevention trial. We assess the uptake of tamoxifen in a consecutive series of premenopausal women not in a trial and explore the reasons for uptake through interviews. Methods: All eligible women between 33 and 46 years at ⩾17% lifetime risk of breast cancer and undergoing annual mammography in our service were invited to take a 5-year course of tamoxifen. Reasons for accepting (n=15) or declining (n=15) were explored using semi-structured interviews. Results: Of 1279 eligible women, 136 (10.6%) decided to take tamoxifen. Women >40 years (74 out of 553 (13.4%)) and those at higher non-BRCA-associated risk were more likely to accept tamoxifen (129 out of 1109 (11.6%)). Interviews highlighted four themes surrounding decision making: perceived impact of side effects, the impact of others' experience on beliefs about tamoxifen, tamoxifen as a ‘cancer drug', and daily reminder of cancer risk. Conclusions: Tamoxifen uptake was similar to previously ascertained uptake in a randomised controlled trial (IBIS-I). Concerns were similar in women who did or did not accept tamoxifen. Decision making appeared to be embedded in the experience of significant others. PMID:24594998

  17. Phase 3 clinical trial investigating the effect of selenium supplementation in men at high risk for prostate cancer

    PubMed Central

    Algotar, Amit M.; Stratton, M. Suzanne; Ahmann, Frederick. R.; Ranger-Moore, James; Nagle, Raymond B.; Thompson, Patricia A.; Slate, Elizabeth; Hsu, Chiu H.; Dalkin, Bruce L.; Sindhwani, Puneet; Holmes, Michael A.; Tuckey, John A.; Graham, David. L.; Parnes, Howard L.; Clark, Lawrence C.; Stratton, Steven P.

    2014-01-01

    Purpose This study was conducted to investigate the effect of Se supplementation on prostate cancer incidence in men at high risk for prostate cancer. Methods A Phase 3 randomized, double-blind, placebo-controlled clinical trial was conducted in 699 men at high risk for prostate cancer (prostate specific antigen (PSA) >4 ng/ml and/or suspicious digital rectal examination and/or PSA velocity >0.75ng/ml/year), but with a negative prostate biopsy. Participants were randomized to receive daily oral placebo (N = 232), 200 µg selenium (N =234), or 400 µg selenium (N=233) as selenized yeast. They were followed every six months for up five years. The time to diagnosis of prostate cancer was compared between treatment groups using the Cox-proportional hazards model. Result Compared to placebo, the hazard ratios [95% confidence intervals] for risk of developing prostate cancer in the selenium 200 µg/day or the selenium 400 µg/day group were 0.94 [0.52, 1.7] and 0.90 [0.48, 1.7] respectively. PSA velocity in the selenium arms was not significantly different from that observed in the placebo group (p=0.18 and p=0.17, respectively). Conclusion Selenium supplementation appeared to have no effect on the incidence of prostate cancer in men at high risk. In conjunction with results of other studies, these data indicate that selenium supplementation may not have a role in prostate cancer chemoprevention. PMID:22887343

  18. 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

  19. Potential modification of the UKPDS risk engine and evaluation of macrovascular event rates in controlled clinical trials

    PubMed Central

    Yang, Fred; Ye, June; Pomerantz, Kenneth; Stewart, Murray

    2013-01-01

    Background The aim of this study was to evaluate a modified UKPDS risk engine in order to establish a risk prediction benchmark for the general diabetes population. Methods Data sources were summary demographic and risk factor data from the major type 2 diabetes mellitus outcomes studies, including ACCORD, ADVANCE, VADT, RECORD, PROactive, ADOPT, and BARI 2D. Patients in these studies spanned a wide spectrum of disease, from drug-naïve to insulin-dependent. Cardiovascular events/major adverse coronary events (CVE/MACE) were primary or safety end points. Overall observed rates for cardiovascular events/MACE were summarized, and the observed annualized event rates were calculated using linear approximation. Simulation studies were then conducted using original (cardiovascular history excluded) and modified (cardiovascular history included) United Kingdom Prospective Diabetes Study (UKPDS) models; the predicted event rates were then compared with the observed event rates for all studies. The consistency of the predicted rates derived from each model was then evaluated using descriptive statistics and linear regression. Results The original UKPDS model tended to overestimate event rates across studies. The ratio of predicted events versus observed MACE ranged from 0.9 to 2.0, with mean of 1.5 ± 0.4 and a coefficient of variation of 26% (R2 = 0.80). However, cardiovascular risk predictions were more precise using a modified UKPDS model; the ratio of predicted versus observed MACE events ranged from 1.8 to 2.4, with a mean of 2.1 ± 0.25 and a coefficient of variation of 13% (R2 = 0.94). Conclusion A modified UKPDS model which includes adjustments for prior cardiovascular history has the potential for use as a tool for benchmarking and may be useful for predicting cardiovascular rates in clinical studies. This modification could be further evaluated, recalibrated, and validated using patient-level information derived from prospective clinical studies to yield greater

  20. 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

  1. 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

  2. Subclinical hypothyroidism is a risk factor for delayed clinical complete response in patients with systemic lupus erythematosus (SLE)

    PubMed Central

    Dong, Lin; Jia, Liu; Hong, Xuezhi; Chen, Guangliang; Mo, Hanyou

    2014-01-01

    The objective of the study was to investigate whether subclinical hypothyroidism is a risk factor for a delayed clinical complete response in patients with SLE. This study included 363 patients with SLE classified according to the ACR classification criteria. These patients were divided into three groups: those who had subclinical hypothyroidism, a euthyroid state, and clinical hypothyroidism. The first group contained 41 cases with SLE and subclinical hypothyroidism, the second group contained 7 cases with SLE and clinical hypothyroidism, and the third group contained 315 positive control cases with SLE and a euthyroid state. Patients were observed for general observational parameters, and an efficacy assessment was performed using SLEDAI, PGA, and SLICC. Results: Patients in the subclinical hypothyroidism group without supplementary treatment had no higher immune activity indicators, SLE activity, and organ damage than those SLE with euthyroid state. These parameters were also no higher than in those who were given treatment in the SLE with clinical hypothyroidism group at 6 months; Immune activity indicators, SLE activity, organ damage, and remission rate were improved after 3 months’ supplementary treatment in 14 subclinical hypothyroidism cases that did not display remission non-remission cases at 6 months. Additionally, no significant difference in remission rate was observed in comparison with the group of SLE patients with a euthyroid state after 6 months’ supplementary treatment. Conclusion: Subclinical hypothyroidism can the slow remission rate of SLE. Supplementary treatment should be performed earlier to improve the remission rate. PMID:25356146

  3. Clinical phenotype clustering in cardiovascular risk patients for the identification of responsive metabotypes after red wine polyphenol intake.

    PubMed

    Vázquez-Fresno, Rosa; Llorach, Rafael; Perera, Alexandre; Mandal, Rupasri; Feliz, Miguel; Tinahones, Francisco J; Wishart, David S; Andres-Lacueva, Cristina

    2016-02-01

    This study aims to evaluate the robustness of clinical and metabolic phenotyping through, for the first time, the identification of differential responsiveness to dietary strategies in the improvement of cardiometabolic risk conditions. Clinical phenotyping of 57 volunteers with cardiovascular risk factors was achieved using k-means cluster analysis based on 69 biochemical and anthropometric parameters. Cluster validation based on Dunn and Figure of Merit analysis for internal coherence and external homogeneity were employed. k-Means produced four clusters with particular clinical profiles. Differences on urine metabolomic profiles among clinical phenotypes were explored and validated by multivariate orthogonal signal correction partial least-squares discriminant analysis (OSC-PLS-DA) models. OSC-PLS-DA of (1)H-NMR data revealed that model comparing "obese and diabetic cluster" (OD-c) against "healthier cluster" (H-c) showed the best predictability and robustness in terms of explaining the pairwise differences between clusters. Considering these two clusters, distinct groups of metabolites were observed following an intervention with wine polyphenol intake (WPI; 733 equivalents of gallic acid/day) per 28days. Glucose was significantly linked to OD-c metabotype (P<.01), and lactate, betaine and dimethylamine showed a significant trend. Tartrate (P<.001) was associated with wine polyphenol intervention (OD-c_WPI and H-c_WPI), whereas mannitol, threonine methanol, fucose and 3-hydroxyphenylacetate showed a significant trend. Interestingly, 4-hydroxyphenylacetate significantly increased in H-c_WPI compared to OD-c_WPI and to basal groups (P<.05)-gut microbial-derived metabolite after polyphenol intake-, thereby exhibiting a clear metabotypic intervention effect. Results revealed gut microbiota responsive phenotypes to wine polyphenols intervention. Overall, this study illustrates a novel metabolomic strategy for characterizing interindividual responsiveness to dietary

  4. Clinical activity and safety of the dual pathway inhibitor rigosertib for higher risk myelodysplastic syndromes following DNA methyltransferase inhibitor therapy.

    PubMed

    Silverman, Lewis R; Greenberg, Peter; Raza, Azra; Olnes, Matthew J; Holland, James F; Reddy, Premkumar; Maniar, Manoj; Wilhelm, Francois

    2015-06-01

    Rigosertib (ON 01910.Na) is an inhibitor of the phosphoinositide 3-kinase and polo-like kinase pathways that induces mitotic arrest and apoptosis in neoplastic cells, while sparing normal cells. Our purpose is to summarize the clinical activity and safety of intravenous (IV) rigosertib delivered by an external ambulatory infusion pump in patients with refractory anemia with excess blasts-1, -2, or, -t myelodysplastic syndromes (MDS) following prior treatment with DNA methyltransferase (DNMT) inhibitors. A total of 39 patients with MDS who fulfilled these criteria were enrolled in four phase 1-2 clinical trials of IV rigosertib. Thirty five (88%) had higher risk disease according to the Revised International Prognostic Scoring System. Median overall survival for this group of 39 patients was 35 weeks. Of 30 evaluable patients with follow-up bone marrow biopsies, 12 (40%) achieved complete (n = 5) or partial (n = 7) bone marrow blast responses. In addition, 15 patients achieved stabilization of bone marrow blasts. One patient with a complete bone marrow response also achieved a complete cytogenetic response. A second patient with stable bone marrow blasts achieved a partial cytogenetic response. Two of the responding patients and three patients with stable disease had hematological improvements. Rigosertib-induced bone marrow blast decreases and stability appeared to be predictive of prolonged survival. IV rigosertib had a favorable safety profile without significant myelosuppression. Most common drug-related toxicities included fatigue, diarrhea, nausea, dysuria, and hematuria. In summary, IV rigosertib is well tolerated and has clinical activity in patients with higher risk MDS following DNMT inhibitor treatment. A multinational pivotal phase 3 randomized clinical trial of rigosertib versus best supportive care for patients with MDS with excess blasts following prior treatment with DNMT inhibitors (ONTIME: ON 01910.Na Trial In Myelodysplastic SyndromE) has recently

  5. 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.

  6. Epidemiology of Pediatric Closed Head Injury: Incidence, Clinical Characteristics, and Risk Factors.

    ERIC Educational Resources Information Center

    Goldstein, Felicia C.; Levin, Harvey S.

    1987-01-01

    The paper reviews the epidemiology of pediatric closed head injury. Incidence rates, etiologic/pathophysiologic correlates, and associated risk factors are discussed. Suggestions offered for future research concern relationships among age, etiology, and pathophysiology in outcome studies and premorbid measures of personality/intellectual…

  7. Pediatric non-Hodgkin's lymphoma: clinical and biologic prognostic factors and risk allocation.

    PubMed

    Weitzman, Sheila; Suryanarayan, Kaveri; Weinstein, Howard J

    2002-03-01

    The use of effective combination chemotherapy for all stages and subtypes of non-Hodgkin"s lymphoma (NHL) in children has resulted in a striking improvement in cure rates. Event-free survival now ranges from 70% to 90%, depending on the stage of disease and the NHL subtype. Risk-adapted therapy has resulted in a dramatic improvement in outcome for high-risk patients, at the cost of significantly increased short-term toxicity, and a reduction of therapy and toxicity for the lower-risk patient, while maintaining the excellent cure rate. Successful risk allocation of patients is dependent on the identification and continual validation of prognostic factors. The specific treatment protocol is the single most important factor predicting outcome today. Traditional prognostic factors such as stage and tumor burden are useful in selecting the intensity and length of therapy, rather than as a major indicator of likelihood of survival. In order to further improve cure rates and decrease toxicity, new biologic prognosticators need to be found and validated. Some promising avenues for study appear to be the presence or absence of adhesion molecules and of aberrant proteins that are specific to subtypes of lymphomas, such as soluble CD30 and anaplastic lymphoma kinase (ALK), the molecular classification of lymphomas on the basis of gene expression, and the evaluation of biologic markers for measuring early response to therapy. PMID:11822982

  8. 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…

  9. 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...

  10. Clinical Assessment of Autism in High-Risk 18-Month-Olds

    ERIC Educational Resources Information Center

    Brian, J.; Bryson, S. E.; Garon, N.; Roberts, W.; Smith, I. M.; Szatmari, P.; Zwaigenbaum, L.

    2008-01-01

    Earlier intervention improves outcomes for children with autism spectrum disorders (ASDs), but existing identification tools are at the limits of standardization with 18-month-olds. We assessed potential behavioural markers of ASD at 18 months in a high-risk cohort of infant siblings of children with ASD. Prospective data were collected using the…

  11. 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…

  12. 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

  13. Relationship between obesity and the risk of clinically significant depression: Mendelian randomisation study

    PubMed Central

    Hung, Chi-Fa; Rivera, Margarita; Craddock, Nick; Owen, Michael J.; Gill, Michael; Korszun, Ania; Maier, Wolfgang; Mors, Ole; Preisig, Martin; Rice, John P.; Rietschel, Marcella; Jones, Lisa; Middleton, Lefkos; Aitchison, Kathy J.; Davis, Oliver S. P.; Breen, Gerome; Lewis, Cathryn; Farmer, Anne; McGuffin, Peter

    2014-01-01

    Background Obesity has been shown to be associated with depression and it has been suggested that higher body mass index (BMI) increases the risk of depression and other common mental disorders. However, the causal relationship remains unclear and Mendelian randomisation, a form of instrumental variable analysis, has recently been employed to attempt to resolve this issue. Aims To investigate whether higher BMI increases the risk of major depression. Method Two instrumental variable analyses were conducted to test the causal relationship between obesity and major depression in RADIANT, a large case-control study of major depression. We used a single nucleotide polymorphism (SNP) in FTO and a genetic risk score (GRS) based on 32 SNPs with well-established associations with BMI. Results Linear regression analysis, as expected, showed that individuals carrying more risk alleles of FTO or having higher score of GRS had a higher BMI. Probit regression suggested that higher BMI is associated with increased risk of major depression. However, our two instrumental variable analyses did not support a causal relationship between higher BMI and major depression (FTO genotype: coefficient –0.03, 95% CI –0.18 to 0.13, P = 0.73; GRS: coefficient –0.02, 95% CI –0.11 to 0.07, P = 0.62). Conclusions Our instrumental variable analyses did not support a causal relationship between higher BMI and major depression. The positive associations of higher BMI with major depression in probit regression analyses might be explained by reverse causality and/or residual confounding. PMID:24809401

  14. Lipid-lowering therapy using statins in patients with cardiovascular risk in clinical practice in Thailand

    PubMed Central

    Silaruks, Songkwan; Sriratanasathavorn, Charn; Rawdaree, Petch; Kunjara-Na-Ayudhaya, Rapeephon; Thinkhamrop, Bandit; Sritara, Piyamitr

    2011-01-01

    Background Since the release in Thailand in 2001 of the Third Guidelines by the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults or the Adult Treatment Panel (ATP III), there have been no nationwide studies on the proportion of dyslipidaemic patients who have achieved the low-density lipoprotein cholesterol (LDL-C) goals. The authors therefore aimed to estimate the percentage achievement of LDL-C goals based on the modified NCEP ATP III guidelines in intermediate- to high-risk patients. Methods The authors conducted a hospital-based, cross-sectional, epidemiological survey. Patients (1240) were selected consecutively from 50 hospitals across Thailand. Patients were included if they had been treated with statins for at least 3 months. Results Two-thirds were female, and the mean age was 61.7±9.5 years. The median duration of statin treatment was 21 months. Half (633/ 1240) of the patients achieved the LDL-C goal levels as defined by the NCEP guidelines (51.1%, 95% CI 48.3% to 53.8%). The very-high-risk group had the lowest percentage achievement (11.6%; 95% CI 1.6% to 21.6%), compared with 54.2% (95% CI 50.9% to 57.4%) for the high-risk group and 47.0% (95% CI 41.1% to 52.8%) for the moderate-risk group. More males achieved the LDL-C goals than females (55.6% vs 48.9%; p=0.029). Conclusions Overall, 51.1% of the patients with cardiovascular risk, on statins treatment, achieved the NCEP ATP III LDL-C goal levels. PMID:27326004

  15. Simulation of multiple ion channel block provides improved early prediction of compounds’ clinical torsadogenic risk

    PubMed Central

    Mirams, Gary R.; Cui, Yi; Sher, Anna; Fink, Martin; Cooper, Jonathan; Heath, Bronagh M.; McMahon, Nick C.; Gavaghan, David J.; Noble, Denis

    2011-01-01

    Aims The level of inhibition of the human Ether-à-go-go-related gene (hERG) channel is one of the earliest preclinical markers used to predict the risk of a compound causing Torsade-de-Pointes (TdP) arrhythmias. While avoiding the use of drugs with maximum therapeutic concentrations within 30-fold of their hERG inhibitory concentration 50% (IC50) values has been suggested, there are drugs that are exceptions to this rule: hERG inhibitors that do not cause TdP, and drugs that can cause TdP but are not strong hERG inhibitors. In this study, we investigate whether a simulated evaluation of multi-channel effects could be used to improve this early prediction of TdP risk. Methods and results We collected multiple ion channel data (hERG, Na, l-type Ca) on 31 drugs associated with varied risks of TdP. To integrate the information on multi-channel block, we have performed simulations with a variety of mathematical models of cardiac cells (for rabbit, dog, and human ventricular myocyte models). Drug action is modelled using IC50 values, and therapeutic drug concentrations to calculate the proportion of blocked channels and the channel conductances are modified accordingly. Various pacing protocols are simulated, and classification analysis is performed to evaluate the predictive power of the models for TdP risk. We find that simulation of action potential duration prolongation, at therapeutic concentrations, provides improved prediction of the TdP risk associated with a compound, above that provided by existing markers. Conclusion The suggested calculations improve the reliability of early cardiac safety assessments, beyond those based solely on a hERG block effect. PMID:21300721

  16. 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

  17. 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

  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. PMID:27318168

  19. 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…

  20. 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,…

  1. 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

  2. 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

  3. Clinical risk factors for osteoporosis are common among elderly people in Nuuk, Greenland

    PubMed Central

    Jakobsen, Anna; Laurberg, Peter; Vestergaard, Peter; Andersen, Stig

    2013-01-01

    Background Osteoporosis is a debilitating condition characterized by fractures, pain and premature death. Risk factors for osteoporosis predict the risk of fragility fractures. Aim To describe the occurrence of risk factors for osteoporosis among populations in Nuuk, the capital of Greenland. Methods A random sample of women born in 1934–42, 1945–47, 1956, and men born in 1956 were selected from the national civil registry. A questionnaire was sent out in Greenlandic and Danish on risk factors for osteoporosis: family history, smoking habits, alcohol intake, presence of disease, sun exposure, intake of dairy products, age at menopause (women) and number of falls. Additional questions included the frequency of back pain, previous fractures, intake of vitamin D and calcium supplements, use of anti-osteoporotic drugs, steroids and other drugs. Results The questionnaire was sent to 317 subjects confirmed to be living at an address in Nuuk and 181 (57.1%) responded. More young women than older women were smokers (60.6% vs. 35.0%; p=0.022) while limited sun exposure was reported by more of the old women (37.2% vs. 5.6%; p=0.003). Family history of osteoporosis was reported by 15.0%, without difference between groups. Alcohol and milk intake did not differ between groups. Premature menopause was reported by 17.9% of the women. Falls within the last year were reported by 42.4% with fewer falls in the oldest age group (21.9% vs. 50.0%; p=0.005). Frequency of fragility fractures increased with age (5.7% vs. 24.3% vs. 30.4%; p=0.02) and the risk of a fragility fracture increased with age (p=0.004; OR, 95% CI: 4.5, 1.6–12.2, reference: below 70 years), when adjusted for smoking, gender and falls. The use of anti-osteoporotic drugs was low (3.4%) while 28.8% took calcium and vitamin D supplements. Conclusions Age is a dominating risk factor for fragility fractures in Greenland. The use of anti-osteoporotic drugs is low in Greenland, even if osteoporotic fractures are

  4. Using Clinical Factors and Mammographic Breast Density to Estimate Breast Cancer Risk: Development and Validation of a New Predictive Model

    PubMed Central

    Tice, Jeffrey A.; Cummings, Steven R.; Smith-Bindman, Rebecca; Ichikawa, Laura; Barlow, William E.; Kerlikowske, Karla

    2009-01-01

    Background Current models for assessing breast cancer risk are complex and do not include breast density, a strong risk factor for breast cancer that is routinely reported with mammography. Objective To develop and validate an easy-to-use breast cancer risk prediction model that includes breast density. Design Empirical model based on Surveillance, Epidemiology, and End Results incidence, and relative hazards from a prospective cohort. Setting Screening mammography sites participating in the Breast Cancer Surveillance Consortium. Patients 1 095 484 women undergoing mammography who had no previous diagnosis of breast cancer. Measurements Self-reported age, race or ethnicity, family history of breast cancer, and history of breast biopsy. Community radiologists rated breast density by using 4 Breast Imaging Reporting and Data System categories. Results During 5.3 years of follow-up, invasive breast cancer was diagnosed in 14 766 women. The breast density model was well calibrated overall (expected–observed ratio, 1.03 [95% CI, 0.99 to 1.06]) and in racial and ethnic subgroups. It had modest discriminatory accuracy (concordance index, 0.66 [CI, 0.65 to 0.67]). Women with low-density mammograms had 5-year risks less than 1.67% unless they had a family history of breast cancer and were older than age 65 years. Limitation The model has only modest ability to discriminate between women who will develop breast cancer and those who will not. Conclusion A breast cancer prediction model that incorporates routinely reported measures of breast density can estimate 5-year risk for invasive breast cancer. Its accuracy needs to be further evaluated in independent populations before it can be recommended for clinical use. PMID:18316752

  5. Clinical and haematological risk factors for cerebral macrovasculopathy in a sickle cell disease newborn cohort: a prospective study.

    PubMed

    Sommet, Julie; Alberti, Corinne; Couque, Nathalie; Verlhac, Suzanne; Haouari, Zinedine; Mohamed, Damir; François, Martine; Missud, Florence; Holvoet, Laurent; Elmaleh, Monique; Ithier, Ghislaine; Denjean, André; Elion, Jacques; Baruchel, André; Benkerrou, Malika

    2016-03-01

    Children with sickle cell disease (SCD) have a significant vascular morbidity, especially cerebral macrovasculopathy (CV), detectable by transcranial Doppler. This study aimed to identify risk factors for CV using longitudinal biological and clinical data in a SCD newborn cohort followed at the Robert Debre Reference centre (n = 375 SS/Sβ(0) ). Median follow-up was 6·8 years (2677 patient-years). Among the 59 children presenting with CV, seven had a stroke. Overall, the incidence of CV was 2·20/100 patient-years [95% confidence interval (95% CI): 1·64-2·76] and the incidence of stroke was 0·26/100 patient-years (95% CI: 0·07-0·46). The cumulative risk of CV by age 14 years was 26·0% (95% CI: 20·0-33·3%). Risk factors for CV were assessed by a Cox model encompassing linear multivariate modelling of longitudinal quantitative variables. Years per upper-airway obstruction [Hazard ratio (HR) = 1·47; 95% CI: 1·05-2·06] or bronchial obstruction (HR = 1·76; 95% CI: 1·49-2·08) and reticulocyte count (HR = 1·82 per 50 × 10(9) /l increase; 95% CI: 1·10-3·01) were independent risk factors whereas fetal haemoglobin level (HR = 0·68 per 5% increase; 95% CI: 0·48-0·96) was protective. Alpha-thalassaemia was not protective in multivariate analysis (ancillary analysis n = 209). Specific treatment for upper or lower-airway obstruction and indirect targeting of fetal haemoglobin and reticulocyte count by hydroxycarbamide could potentially reduce the risk of CV. PMID:26728571

  6. 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.

  7. An Official American Thoracic Society Clinical Practice Guideline: Diagnosis, Risk Stratification, and Management of Pulmonary Hypertension of Sickle Cell Disease

    PubMed Central

    Klings, Elizabeth S.; Machado, Roberto F.; Barst, Robyn J.; Morris, Claudia R.; Mubarak, Kamal K.; Gordeuk, Victor R.; Kato, Gregory J.; Ataga, Kenneth I.; Gibbs, J. Simon; Castro, Oswaldo; Rosenzweig, Erika B.; Sood, Namita; Hsu, Lewis; Wilson, Kevin C.; Telen, Marilyn J.; DeCastro, Laura M.; Krishnamurti, Lakshmanan; Steinberg, Martin H.; Badesch, David B.; Gladwin, Mark T.

    2014-01-01

    Background: In adults with sickle cell disease (SCD), an increased tricuspid regurgitant velocity (TRV) measured by Doppler echocardiography, an increased serum N-terminal pro–brain natriuretic peptide (NT-pro-BNP) level, and pulmonary hypertension (PH) diagnosed by right heart catheterization (RHC) are independent risk factors for mortality. Methods: A multidisciplinary committee was formed by clinician-investigators experienced in the management of patients with PH and/or SCD. Clinically important questions were posed, related evidence was appraised, and questions were answered with evidence-based recommendations. Target audiences include all clinicians who take care of patients with SCD. Results: Mortality risk stratification guides decision making. An increased risk for mortality is defined as a TRV equal to or greater than 2.5 m/second, an NT-pro-BNP level equal to or greater than 160 pg/ml, or RHC-confirmed PH. For patients identified as having increased mortality risk, we make a strong recommendation for hydroxyurea as first-line therapy and a weak recommendation for chronic transfusions as an alternative therapy. For all patients with SCD with elevated TRV alone or elevated NT-pro-BNP alone, and for patients with SCD with RHC-confirmed PH with elevated pulmonary artery wedge pressure and low pulmonary vascular resistance, we make a strong recommendation against PAH-specific therapy. However, for select patients with SCD with RHC-confirmed PH who have elevated pulmonary vascular resistance and normal pulmonary capillary wedge pressure, we make a weak recommendation for either prostacyclin agonist or endothelin receptor antagonist therapy and a strong recommendation against phosphodiesterase-5 inhibitor therapy. Conclusions: Evidence-based recommendations for the management of patients with SCD with increased mortality risk are provided, but will require frequent reassessment and updating. PMID:24628312

  8. 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…

  9. Risk scoring for prediction of acute cardiac complications from imbalanced clinical data.

    PubMed

    Liu, Nan; Koh, Zhi Xiong; Chua, Eric Chern-Pin; Tan, Licia Mei-Ling; Lin, Zhiping; Mirza, Bilal; Ong, Marcus Eng Hock

    2014-11-01

    Fast and accurate risk stratification is essential in the emergency department (ED) as it allows clinicians to identify chest pain patients who are at high risk of cardiac complications and require intensive monitoring and early intervention. In this paper, we present a novel intelligent scoring system using heart rate variability, 12-lead electrocardiogram (ECG), and vital signs where a hybrid sampling-based ensemble learning strategy is proposed to handle data imbalance. The experiments were conducted on a dataset consisting of 564 chest pain patients recruited at the ED of a tertiary hospital. The proposed ensemble-based scoring system was compared with established scoring methods such as the modified early warning score and the thrombolysis in myocardial infarction score, and showed its effectiveness in predicting acute cardiac complications within 72 h in terms of the receiver operation characteristic analysis. PMID:25375686

  10. Quinolone-resistant Campylobacter Infections: Risk Factors and Clinical Consequences1

    PubMed Central

    Neimann, Jakob; Nielsen, Eva Møller; Aarestrup, Frank Møller; Fussing, Vivian

    2004-01-01

    We integrated data on quinolone and macrolide susceptibility patterns with epidemiologic and typing data from Campylobacter jejuni and C. coli infections in two Danish counties. The mean duration of illness was longer for 86 patients with quinolone-resistant C. jejuni infections (median 13.2 days) than for 381 patients with quinolone-sensitive C. jejuni infections (median 10.3 days, p = 0.001). Foreign travel, eating fresh poultry other than chicken and turkey, and swimming were associated with increased risk for quinolone-resistant C. jejuni infection. Eating fresh chicken (of presumably Danish origin) was associated with a decreased risk. Typing data showed an association between strains from retail food products and broiler chickens and quinolone-sensitive domestically acquired C. jejuni infections. An association between treatment with a fluoroquinolone before stool-specimen collection and having a quinolone-resistant C. jejuni infection was not observed. PMID:15207057

  11. Heroin use, HIV-risk, and criminal behavior in Baltimore: Findings from Clinical Research

    PubMed Central

    Schwartz, Robert P.; Kelly, Sharon M.; Gryczynski, Jan; Mitchell, Shannon Gwin; O’Grady, Kevin E.; Jaffe, Jerome H.

    2015-01-01

    This paper reviews research conducted in Baltimore over the past 15 years that examined accessibility and barriers to methadone treatment, compared those who enter treatment to those who do not, studied retention and counseling issues, as well as the impact of treatment on criminality, HIV risk among participants and overdose death in the community. Recommendations to develop policies are presented to reduce heroin use and its negative impact in the community. PMID:26079104

  12. Psoriasis and the Risk of Major Cardiovascular Events: Cohort Study Using the Clinical Practice Research Datalink.

    PubMed

    Parisi, Rosa; Rutter, Martin K; Lunt, Mark; Young, Helen S; Symmons, Deborah P M; Griffiths, Christopher E M; Ashcroft, Darren M

    2015-09-01

    The association between psoriasis and risk of major cardiovascular (CV) events (myocardial infarction, acute coronary syndrome, unstable angina, and stroke) is unclear. A cohort study with 48,523 patients with psoriasis and 208,187 controls was conducted. During a median follow-up of 5.2 years, 1,257 patients with psoriasis (2.59%) had a major CV event, compared with 4,784 controls (2.30%). In the multivariable analysis, inflammatory arthritis hazard ratio (HR) 1.36 (1.18-1.58), diabetes HR 1.18 (1.06-1.31), chronic kidney disease HR 1.18 (1.07-1.31), hypertension HR 1.37 (1.29-1.45), transient ischemic attack HR 2.74 (2.41-3.12), atrial fibrillation HR 1.54 (1.36-1.73), valvular heart disease HR 1.23 (1.05-1.44), thromboembolism 1.32 (1.17-1.49), congestive heart failure HR 1.57 (1.39-1.78), depression HR 1.16 (1.01-1.34), current smoker HR 2.18 (2.03-2.33), age (year) HR 1.07 (1.07-1.07), and male gender HR 1.83 (1.69-1.98) were statistically significant for the risk of major CV events. The age- and gender-adjusted HRs of a major CV event for psoriasis were 1.10 (1.04-1.17) and for severe psoriasis 1.40 (1.07-1.84), whereas the fully adjusted HRs were attenuated to 1.02 (0.95-1.08) and 1.28 (0.96-1.69). In conclusion, neither psoriasis nor severe psoriasis were associated with the short-to-medium term (over 3-5 years) risk of major CV events after adjusting for known cardiovascular disease risk factors. PMID:25742120

  13. [Risk factors for clinical signs of PMWS and PDNS in pigs in The Netherlands: a case-control study].

    PubMed

    Elbers, A R W; de Jong, M F; Wellenberg, G J

    2006-05-01

    Potential risk factors for clinical signs of post-weaning multisystemic wasting syndrome (PMWS) and porcine dermatitis and nephropathy syndrome (PDNS) in pigs in the Netherlands were investigated in a matched case-control study using a questionnaire (personal interview). Eighty-two pig farmers were questioned about management, hygiene, husbandry systems, disease history, and preventive health care. In this study, 30 pig herds with (cases) and 30 pig herds without (controls) characteristic clinical signs of PMWS were compared. For PDNS, 11 pig herds with (cases) and II pig herds without (controls) characteristic clinical signs of PDNS were compared. Univariate analysis (P < 0.10) showed that the following occurred relatively more often in the PMWS case herds than in the control herds: 1) clinical signs of PDNS, porcine reproductive and respiratory syndrome (PRRS), porcine parvovirus (PPV) infections, meningitis, coccidiosis, and pre-weaning diarrhoea observed by the farmer; 2) vaccination against PRRS and mycoplasma; 3) non-optimal climatic conditions in the nursery rooms, a large variation in weaning age, a high occurrence of cross-fostering of piglets, a large number of sows with lactation problems, poor colostrum intake by piglets; and 4) (historical) use of breeding stock (including semen for artificial insemination) of Anglo-Saxon origin. In the final multivariate statistical model, one variable remained significantly associated with PMWS case herds, namely, the presence of clinical signs of PRRS (and/or the associated use of vaccination against PRRS). It should be noted that in almost all cases animals were vaccinated against PRRS because of clinical signs of PRRS that appeared a few months after the first occurrence of clinical signs of PMWS. This excludes PRRS vaccination as a primary factor in causing PMWS. Analysis of the PDNS case-control data showed comparable results with those of the PMWS study. In the final statistical model, the presence of clinical

  14. The Risks to Patient Privacy from Publishing Data from Clinical Anesthesia Studies.

    PubMed

    O'Neill, Liam; Dexter, Franklin; Zhang, Nan

    2016-06-01

    In this article, we consider the privacy implications of posting data from small, randomized trials, observational studies, or case series in anesthesia from a few (e.g., 1-3) hospitals. Prior to publishing such data as supplemental digital content, the authors remove attributes that could be used to re-identify individuals, a process known as "anonymization." Posting health information that has been properly "de-identified" is assumed to pose no risks to patient privacy. Yet, computer scientists have demonstrated that this assumption is flawed. We consider various realistic scenarios of how the publication of such data could lead to breaches of patient privacy. Several examples of successful privacy attacks are reviewed, as well as the methods used. We survey the latest models and methods from computer science for protecting health information and their application to posting data from small anesthesia studies. To illustrate the vulnerability of such published data, we calculate the "population uniqueness" for patients undergoing one or more surgical procedures using data from the State of Texas. For a patient selected uniformly at random, the probability that an adversary could match this patient's record to a unique record in the state external database was 42.8% (SE < 0.1%). Despite the 42.8% being an unacceptably high level of risk, it underestimates the risk for patients from smaller states or provinces. We propose an editorial policy that greatly reduces the likelihood of a privacy breach, while supporting the goal of transparency of the research process. PMID:27172145

  15. Understanding and responding to HIV risk in youngSouth African women: Clinical perspectives.

    PubMed

    Dellar, R; Karim, Q Abdool

    2015-11-01

    Young women (15-24 years) contribute a disproportionate 24% to all new HIV infections in South Africa – more than four times that of their male peers. HIV risk in young women is driven by amplifying cycles of social, behavioural and biological vulnerability. Those most likely to acquire infection are typically from socioeconomically deprived households in high HIV-prevalence communities, have limited or no schooling, engage in transactional sex or other high-risk coping behaviours, and have a history of sexually transmitted infections (STIs)and/or pregnancy. Despite the imperative to prevent HIV acquisition in young women, there is a dearth of evidence-based interventions to do so. However, there are several steps that healthcare workers can take to improve outcomes for this key population at the individual level.These include being able to identify high HIV-risk young women, ensuring that they receive the maximum social support they are eligible for, providing reliable and non-judgemental counselling on sexual and reproductive health and relationships, delivering contraceptives and screening and treating STIs in the context of accessible, youth-friendly services. PMID:26937509

  16. Moderator's view: Salt, cardiovascular risk, observational research and recommendations for clinical practice.

    PubMed

    Zoccali, Carmine; Mallamaci, Francesca

    2016-09-01

    In observational studies, blood pressure (BP), cholesterol and nutritional status biomarkers, including sodium intake, coherently show a J- or U-shaped relationship with health outcomes. Yet these data may reflect a stable sodium intake or a reduced intake due to comorbidities or intercurrent disease, or an intentional decrease in salt intake. Adjusting for comorbidities and risk factors may fail to eliminate confounding. For cholesterol and BP, we base our recommendations for prevention and treatment on interventional (experimental) studies. For sodium, we lack the perfect large-scale trial we would need, but substantial circumstantial information derived from interventional studies cannot be ignored. The objection that modelling the risk of salt excess for cardiovascular disease events based on the effect of salt intake on BP is unjustified fails to consider a recent meta-analysis showing that, independently of the intervention applied, intensive BP-lowering treatment (average BP 133/76 mmHg), compared with the less intensive treatment (140/81 mmHg), is associated with a 14% risk reduction for major cardiovascular events. In this knowledge context, inertia, i.e. awaiting the 'mother trial', is not justified. While recognizing that this trial may still be needed and that actual data, rather than modelled data, are the ideal solution, for now, the World Health Organization recommendation of reducing salt intake to <2 g/day of sodium (5 g/day of salt) in adults stands. PMID:27488353

  17. Contributions of Early Cortical Processing and Reading Ability to Functional Status in Individuals at Clinical High Risk for Psychosis

    PubMed Central

    Carrión, Ricardo E.; Cornblatt, Barbara A.; McLaughlin, Danielle; Chang, Jeremy; Auther, Andrea M.; Olsen, Ruth H.; Javitt, Daniel C.

    2015-01-01

    Background There is a growing recognition that individuals at clinical high risk need intervention for functional impairments, along with emerging psychosis, as the majority of clinical high risk (CHR) individuals show persistent deficits in social and role functioning regardless of transition to psychosis. Recent studies have demonstrated reduced reading ability as a potential cause of functional disability in schizophrenia, related to underlying deficits in generation of mismatch negativity (MMN). The present study extends these findings to subjects at CHR. Methods The sample consisted of 34 CHR individuals and 33 healthy comparisons subjects (CNTLs) from the Recognition and Prevention (RAP) Program at the Zucker Hillside Hospital in New York. At baseline, reading measures were collected, along with MMN to pitch, duration, and intensity deviants, and measures of neurocognition, and social and role (academic/work) functioning. Results CHR subjects showed impairments in reading ability, neurocognition, and MMN generation, relative to CNTLs. Lower-amplitude MMN responses were correlated with worse reading ability, slower processing speed, and poorer social and role functioning. However, when entered into a simultaneous regression, only reduced responses to deviance in sound duration and volume predicted poor social and role functioning, respectively. Conclusions Deficits in reading ability exist even prior to illness onset in schizophrenia and may represent a decline in performance from prior abilities. As in schizophrenia, deficits are related to impaired MMN generation, suggesting specific contributions of sensory-level impairment to neurocognitive processes related to social and role function. PMID:25728833

  18. Types, Risk Factors, Clinical symptoms and Diagnostic Tests of Acute Adult Meningitis in Northern Iran During 2006-2012

    PubMed Central

    Bagheri-Nesami, Masoumeh; Babamahmoodi, Farhang

    2015-01-01

    Background Acute bacterial meningitis is a medical emergency condition that requires prompt diagnosis and treatment and otherwise associated with serious morbidity and mortality. Aim The aim of this study was to assess types, risk factors, clinical symptoms and diagnostic tests of meningitis in hospitalized patients of Mazandaran University of medical sciences hospitals during 2006-2012. Matherials and Methods This is a retrospective descriptive study. Following approval of the ethics committee of Mazandaran University of Medical Sciences, records of adult patients diagnosed with acute meningitis from 2006 to 2012 were extracted from Mazandaran Provincial Health Center and patients attending hospitals affiliated to Mazandaran University of Medical Sciences. Statistical Analysis Data were analyzed with SPSS-16 using descriptive statistics (frequency, mean, standard deviation, and median). Results In this study, of the 137 patients with meningitis, 73 (53.9%) were viral, 61 (46%) bacterial, 1 (0.7%) fungal, and 2 (1.4%) unknown. The majority of risk factors in patients were head trauma, upper respiratory infection, and drug addiction. The most common clinical signs were headache, fever, nausea and vomiting, and stiff neck. Conclusion In this study, the incidence of meningitis was much lower than any other country. It could be due to geographic variation or incomplete recording of patient's data. It is recommended to perform a longitudinal study during the coming years on patients with meningitis. PMID:26155497

  19. Environmental Air Pollutants as Risk Factors for Asthma Among Children Seen in Pediatric Clinics in UKMMC, Kuala Lumpur.

    PubMed

    Idris, Idayu Badilla; Ghazi, Hasanain Faisal; Zhie, Khor Hui; Khairuman, Khairul Aliff; Yahya, Siti Kasuma; Abd Zaim, Farah Azureen; Nam, Chok Wai; Abdul Rasid, Hazwan Zuhairi; Isa, Zaleha Md

    2016-01-01

    The prevalence of asthma is increasing, especially among children in Malaysia, with environmental factors as one of the main preventable contributors. The aim of this study was to determine the association between environmental air pollutants and the occurrence of asthma among children seen in pediatric clinics in Universiti Kebangsaan Malaysia Medical Center (UKMMC), Kuala Lumpur. An unmatched case control study among children who attended the pediatric clinic was carried out from May to August 2015. A total of 223 children who were diagnosed with asthma (105 cases) and who did not have asthma (118 controls) were included in this study. Their parents or caregivers were interviewed using questionnaires modified from the International Study of Asthma and Allergies in Childhood. Data obtained were analyzed using SPSS software version 20. There was a higher risk of asthma in those who had carpet at home (OR = 2.15 CI [1.25-3.68]), those who lived within 200 m of heavy traffic (OR = 1.72 CI [1.01-2.93]), and those who were exposed to lorry fumes (OR = 2.61. CI [1.38-4.93]). Environmental air pollutants increased the risk of asthma among children in Malaysia. Exposure to congested roads, lorry fumes, and indoor carpet were associated with asthma among children in this study. Parents or caretakers of children with asthma should be given adequate education on the prevention of asthmatic attack among these children. PMID:27325078

  20. Sample Size Considerations in Clinical Trials when Comparing Two Interventions using Multiple Co-Primary Binary Relative Risk Contrasts

    PubMed Central

    Ando, Yuki; Hamasaki, Toshimitsu; Evans, Scott R.; Asakura, Koko; Sugimoto, Tomoyuki; Sozu, Takashi; Ohno, Yuko

    2015-01-01

    The effects of interventions are multi-dimensional. Use of more than one primary endpoint offers an attractive design feature in clinical trials as they capture more complete characterization of the effects of an intervention and provide more informative intervention comparisons. For these reasons, multiple primary endpoints have become a common design feature in many disease areas such as oncology, infectious disease, and cardiovascular disease. More specifically in medical product development, multiple endpoints are utilized as co-primary to evaluate the effect of the new interventions. Although methodologies to address continuous co-primary endpoints are well-developed, methodologies for binary endpoints are limited. In this paper, we describe power and sample size determination for clinical trials with multiple correlated binary endpoints, when relative risks are evaluated as co-primary. We consider a scenario where the objective is to evaluate evidence for superiority of a test intervention compared with a control intervention, for all of the relative risks. We discuss the normal approximation methods for power and sample size calculations and evaluate how the required sample size, power and Type I error vary as a function of the correlations among the endpoints. Also we discuss a simple, but conservative procedure for appropriate sample size calculation. We then extend the methods allowing for interim monitoring using group-sequential methods. PMID:26167243

  1. Development of an At-Risk Assessment Approach to Dietary Data Quality in a Food-Based Clinical Trial.

    PubMed

    Guan, Vivienne; Probst, Yasmine; Neale, Elizabeth; Martin, Allison; Tapsell, Linda

    2016-01-01

    Accurate and valid dietary data is the basis to investigate diet-disease relationships. Potential data discrepancies may be introduced when collecting and analysing data, despite rigorous quality assurance protocols. The aim of this study was to identify at-risk areas of dietary data in a food-based clinical trial. Source data verification was performed on a 10% random sample (n=38) of paper-based baseline diet history interview records in a registered clinical trial. All items listed in the source data underwent 100% manual verification based on the food input data from FoodWorks nutrient analysis software. Food item discrepancies were explored using food categories and summarised based on meals. The differences in identified discrepancies for energy and macronutrient output generated from FoodWorks software between previously entered data and re-entered data were compared. An overall discrepancy rate of 4.88% was identified. It was found that dinner intake data were more prone to discrepancy incidences than breakfast, lunch and snacks. Furthermore, assessing intake based on reported quantity and frequency may be more effective to correct discrepancies for quality improvement. Therefore, the dinner meal appeared to be an at risk area of dietary data. The method implemented in this study offers a systematic approach to evaluating dietary data in a research setting. PMID:27440286

  2. Clinical implementation of dose-volume histogram predictions for organs-at-risk in IMRT planning

    NASA Astrophysics Data System (ADS)

    Moore, K. L.; Appenzoller, L. M.; Tan, J.; Michalski, J. M.; Thorstad, W. L.; Mutic, S.

    2014-03-01

    True quality control (QC) of the planning process requires quantitative assessments of treatment plan quality itself, and QC in IMRT has been stymied by intra-patient anatomical variability and inherently complex three-dimensional dose distributions. In this work we describe the development of an automated system to reduce clinical IMRT planning variability and improve plan quality using mathematical models that predict achievable OAR DVHs based on individual patient anatomy. These models rely on the correlation of expected dose to the minimum distance from a voxel to the PTV surface, whereby a three-parameter probability distribution function (PDF) was used to model iso-distance OAR subvolume dose distributions. DVH models were obtained by fitting the evolution of the PDF with distance. Initial validation on clinical cohorts of 40 prostate and 24 head-and-neck plans demonstrated highly accurate model-based predictions for achievable DVHs in rectum, bladder, and parotid glands. By quantifying the integrated difference between candidate DVHs and predicted DVHs, the models correctly identified plans with under-spared OARs, validated by replanning all cases and correlating any realized improvements against the predicted gains. Clinical implementation of these predictive models was demonstrated in the PINNACLE treatment planning system by use of existing margin expansion utilities and the scripting functionality inherent to the system. To maintain independence from specific planning software, a system was developed in MATLAB to directly process DICOM-RT data. Both model training and patient-specific analyses were demonstrated with significant computational accelerations from parallelization.

  3. Clinical Outcome of Radioiodine Therapy in Low-intermediate Risk Papillary Thyroid Carcinoma with BRAF(V600E) Mutation.

    PubMed

    Jiao, L I; Tao, Yang; Teng, Zhao; Jun, Liang; Yan-Song, Lin

    2016-06-10

    Objective To evaluate the impact of BRAF(V600E) gene status on clinical outcome of radioiodine((131)I) therapy in low-intermediate risk recurrent papillary thyroid carcinoma (PTC). Methods Totally 135 PTC patients were enrolled and divided into two groups according to BRAF(V600E) gene status:BRAF(V600E) mutation group(n=105) and BRAF(V600E) wild group(n=30). The median follow-up time was 2.16 years(1.03-4.06 years),and clinical outcome after initial (131)I ablation therapy was divided into excellent response(ER),acceptable response(AR),and incomplete response(IR) according to the serological and imageological follow-up results. The cinical outcomes were then compared between these two groups. Results There was no significant difference in clinicopathological features and initial radioactive iodine dose between BRAF(V600E) mutation and wild groups (P>0.05). ER,AR,and IR after (131)I ablation therapy accounted for 74.3%,20.0%,and 5.7% in BRAF(V600E) mutation group and 73.3%,20.0%,and 6.7% in BRAF(V600E) wild group,and no statistical difference was found (P=0.891). Conclusion For low-intermediate risk recurrent PTC,BRAF(V600E) gene status may have no impact on the response to (131)I ablation therapy,and thus this molecular feature should not be used as an independent weighting factor for risk assessment in this population. PMID:27544995

  4. Comatose and noncomatose adult diabetic ketoacidosis patients at the University Teaching Hospital, Zambia: Clinical profiles, risk factors, and mortality outcomes

    PubMed Central

    Kakusa, Mwanja; Kamanga, Brown; Ngalamika, Owen; Nyirenda, Soka

    2016-01-01

    Background: Diabetic ketoacidosis (DKA) is one of the commonly encountered diabetes mellitus emergencies. Aim: This study aimed at describing the clinical profiles and hospitalization outcomes of DKA patients at the University Teaching Hospital (UTH) in Lusaka, Zambia and to investigate the role of coma on mortality outcome. Materials and Methods: This was a cross-sectional analytical study of hospitalized DKA patients at UTH. The data collected included clinical presentation, precipitating factors, laboratory profiles, complications, and hospitalization outcomes. Primary outcome measured was all-cause in-hospital mortality. Results: The median age was 40 years. Treatment noncompliance was the single highest identified risk factor for development of DKA, followed by new detection of diabetes, then infections. Comatose patients were significantly younger, had lower baseline blood pressure readings, and higher baseline respiratory rates compared to noncomatose patients. In addition, comatose patients had higher baseline admission random blood glucose readings. Their baseline sodium and chloride levels were also higher. The prevalences of hypokalemia, hypernatremia, and hyperchloremia were also higher among comatose patients compared to noncomatose patients. Development of aspiration during admission with DKA, pneumonia at baseline, development of renal failure, and altered mental status were associated with an increased risk of mortality. Development of renal failure was independently predictive of mortality. Conclusion: The mortality rate from DKA hospitalizations is high at UTH. Treatment noncompliance is the single highest identifiable precipitant of DKA. Aspiration, development of renal failure, altered sensorium, and pneumonia at baseline are associated with an increased risk of mortality. Development of renal failure during admission is predictive of mortality. PMID:27042416

  5. Age and regional differences in clinical presentation and risk of hospitalization for dengue in Brazil, 2000-2014

    PubMed Central

    Burattini, Marcelo N.; Lopez, Luis F.; Coutinho, Francisco A.B.; Siqueira, João B.; Homsani, Sheila; Sarti, Elsa; Massad, Eduardo

    2016-01-01

    OBJECTIVES: Dengue cases range from asymptomatic to severe, eventually leading to hospitalization and death. Timely and appropriate management is critical to reduce morbidity. Since 1980, dengue has spread throughout Brazil, affecting an increasing number of individuals. This paper describes age and regional differences in dengue’s clinical presentation and associated risk of hospitalization based on more than 5 million cases reported to the Brazilian Ministry of Health from 2000-2014. METHODS: We performed a retrospective analysis of ∼5,450,000 dengue cases, relating clinical manifestations and the risk of hospitalization to age, gender, previous infection by dengue, dengue virus serotype, years of formal education, delay to first attendance and the occurrence of dengue during outbreaks and in different Brazilian regions. RESULTS: Complicated forms of dengue occurred more frequently among those younger than 10 years (3.12% vs 1.92%) and those with dengue virus 2 infection (7.65% vs 2.42%), with a delay to first attendance >2 days (3.18% vs 0.82%) and with ≤4 years of formal education (2.02% vs 1.46%). The risk of hospitalization was higher among those aged 6-10 years old (OR 4.57; 95% CI 1.43-29.96) and those who were infected by dengue virus 2 (OR 6.36; 95% CI 2.52-16.06), who lived in the Northeast region (OR 1.38; 95% CI 1.11-2.10) and who delayed first attendance by >5 days (composite OR 3.15; 95% CI 1.33-8.9). CONCLUSIONS: In Brazil, the occurrence of severe dengue and related hospitalization is associated with being younger than 10 years old, being infected by dengue virus 2 or 3, living in the Northeast region (the poorest and the second most populated) and delaying first attendance for more than 2 days.

  6. Treatment discontinuation and clinical outcomes in the 1-year naturalistic treatment of patients with schizophrenia at risk of treatment nonadherence

    PubMed Central

    Kelin, Katarina; Lambert, Timothy JR; Brnabic, Alan JM; Newton, Richard; Ye, Wendy; Escamilla, Raúl I; Chen, Kuang-Peng; Don, Liana; Montgomery, William; Karagianis, Jamie; Ascher-Svanum, Haya

    2011-01-01

    Background: This study aimed to improve physicians’ understanding of the treatment circumstances and needs of outpatients with schizophrenia at risk of nonadherence, by naturalistically assessing antipsychotic treatment patterns, clinical outcomes, and health care service use in this little-studied patient population. Methods: In this one-year, prospective, multicenter, noninterventional, observational study, patients considered at risk of nonadherence by their physicians were switched from their primary oral antipsychotic to another oral or a depot antipsychotic at study entry. All cause treatment discontinuation (antipsychotic switch, augmentation, or discontinuation) during the study was assessed using Kaplan–Meier survival analyses and descriptive statistics. Patients’ illness severity, quality of life, attitude towards medication, patient-reported adherence, and health care resource utilization were assessed during the study. Results: Of the 406 enrolled patients, 43 (10.6%) were switched to depot and 363 (89.4%) were switched to oral antipsychotics at study entry. During the study, 99 (24.4%) patients switched, augmented, or discontinued their antipsychotic (all cause treatment discontinuation). Of the 99 patients who switched, augmented, or d