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Sample records for 4-item clinical risk

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

    PubMed

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

    2011-06-01

    The 16-item Negative Symptom Assessment (NSA-16) scale is a validated tool for evaluating negative symptoms of schizophrenia. The psychometric properties and predictive power of a four-item version (NSA-4) were compared with the NSA-16. Baseline data from 561 patients with predominant negative symptoms of schizophrenia who participated in two identically designed clinical trials were evaluated. Ordered logistic regression analysis of ratings using NSA-4 and NSA-16 were compared with ratings using several other standard tools to determine predictive validity and construct validity. Internal consistency and test--retest reliability were also analyzed. NSA-16 and NSA-4 scores were both predictive of scores on the NSA global rating (odds ratio = 0.83-0.86) and the Clinical Global Impressions--Severity scale (odds ratio = 0.91-0.93). NSA-16 and NSA-4 showed high correlation with each other (Pearson r = 0.85), similar high correlation with other measures of negative symptoms (demonstrating convergent validity), and lesser correlations with measures of other forms of psychopathology (demonstrating divergent validity). NSA-16 and NSA-4 both showed acceptable internal consistency (Cronbach α, 0.85 and 0.64, respectively) and test--retest reliability (intraclass correlation coefficient, 0.87 and 0.82). This study demonstrates that NSA-4 offers accuracy comparable to the NSA-16 in rating negative symptoms in patients with schizophrenia. Copyright © 2011 John Wiley & Sons, Ltd.

  2. 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

  3. Clinical risk modification.

    PubMed

    Wilson, J

    Claims for compensation in cases of clinical negligence have risen dramatically in recent years. The implementation of the NHS reforms, with greater clarity of roles and responsibilities and the emphasis on devolving decision-making as close to the patient as possible, is meant to affect the entire performance of healthcare delivery. For most senior managers and clinicians, the environment in which they operate has grown increasingly turbulent and complex. Both purchasers and providers of health care want the best and most effective and efficient care. The cost and quality of care are components in determining the value of health care delivered, and both are elements of healthcare risk. To begin to manage these elements of risk, the process of healthcare risk modification can be applied. Healthcare risk modification provides the best service for patients through obtaining a synergy between risk management, quality and the law.

  4. Clinical risk management in obstetrics.

    PubMed

    Holden, Deborah A; Quin, Maureen; Holden, Des P

    2004-04-01

    Over recent years there has been a growing appreciation that a small but significant proportion of patients experience (sometimes serious) adverse events in the hands of health care workers. Although research in this area is very much in its infancy there has been an increasing move towards applying principles of risk management from industry to health care organizations. With the particularly disastrous and costly nature of adverse outcomes in obstetrics it is appropriate to review clinical risk management issues in maternity. This review explores the appropriateness of applying lessons learned in industry to maternity. The classification of errors into individual and latent, or organizational, is examined. Furthermore, the way in which these errors can be identified and subsequently analysed, with examples from maternity units in the UK and USA, is discussed. The importance of an educational and supportive environment, rather than a blame culture, for both reporting of incidents and learning from adverse outcomes is emphasized. Improvement in patient experience of health care rests not just with improved treatments, but also with a reduction in the adverse events which occur in health care institutions. The principles by which risk can be identified prospectively and retrospectively, and the mechanisms for both local risk management and regional/national reporting and learning are considered.

  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. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. Reliability and Validity of the 4-Item Version of the Korean Perceived Stress Scale.

    PubMed

    Kim, Hee-Ju

    2016-12-01

    This study was designed to evaluate the reliability (internal consistency, reproducibility over time, and measurement precision) and validity (factorial, convergent, and concurrent validity) of the 4-item Korean Perceived Stress Scale in comparison to the 10-item Korean Perceived Stress Scale. Participants were 650 students from seven schools of nursing in South Korea. Measures included Korean versions of the Perceived Stress Scale, the Pittsburgh Sleep Quality Index, and a single-item quality-of-life measure. The 4-item Perceived Stress Scale had lower Cronbach alpha than the 10-item Perceived Stress Scale (.65 vs. .80), but its item-total correlations (.35-.47) and split-half coefficient (.81) were comparable to the 10-item Perceived Stress Scale (item-total correlations = .20-.56; split-half coefficient = .82). Reproducibility of the 4-item scale after a 1-week interval (r = .67, ICC absolute agreement = .64) was similar to the 10-item scale (r = .70, ICC absolute agreement = .65). The standard error of measurement was slightly higher in the 4-item scale. Scale constructs of the two were identical in exploratory factor analysis. The two scales were highly correlated (r = .93) and showed similar levels of concurrent validity with sleep quality and quality of life. In conclusion, the 4- and 10-item Korean Perceived Stress Scale are similar in psychometric qualities. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  12. [The relevance of clinical risk management].

    PubMed

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

    2011-01-01

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

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

    PubMed

    Sharkey, S

    1997-01-22

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

  14. [Profitability analysis of clinical risk management].

    PubMed

    Banduhn, C; Schlüchtermann, J

    2013-05-01

    Medical treatment entails many risks. Increasingly, the negative impact of these risks on patients' health is revealed and corresponding cases are reported to hospital insurances. A systematic clinical risk management can reduce risks. This analysis is designed to demonstrate the financial profitability of implementing a clinical risk management. The decision analysis of a clinical risk management includes information from published articles and studies, publicly available data from the Federal Statistical Office and expert interviews and was conducted in 2 scenarios. The 2 scenarios result from a maximum and minimum value of preventable adverse events reported in Germany. The planning horizon was a 1-year ­period. The analysis was performed from a hospital's perspective. Subsequently, a threshold-analysis of the reduction of preventable adverse events as an effect of clinical risk management was executed. Furthermore, a static capital budgeting over a 5-year period was added, complemented by a risk analysis. Regarding the given assumptions, the implementation of clinical risk management would save about 53 000 € or 175 000 €, respectively, for an average hospital within the first year. Only if the reduction of preventable adverse events is as low as 5.6 or 2.8%, respectively, will the implementation of clinical risk management produce losses. According to a comprehensive risk simulation this happens in less than one out of 1 million cases. The investment in a clinical risk management, based on a 5-year period and an interest rate of 5%, has an annually pay off of 81 000 € or 211 000 €, respectively. The implementation of clinical risk management in a hospital pays off within the first year. In the subsequent years the surplus is even higher due to the elimination of implementation costs. © Georg Thieme Verlag KG Stuttgart · New York.

  15. [Clinical variables of preoperative risk].

    PubMed

    Saad, I A; Zambon, L

    2001-01-01

    To identify risk variables leading to early postoperative pulmonary complication (POPC) in thoracic and upper abdominal surgery. 297 patients submitted to elective surgery were classified as low, moderate and high risk for POPC using PORT scale, following Torrington & Henderson (1988). The patients were followed up for 72 hours postoperative. POPC were defined as atelectasis, pneumonia, tracheobronchitis, wheezing, prolonged intubation and/or prolonged mechanical ventilation. Univariate analysis was applied to study these independent variables: type of surgery, age, nutritional status (BMI), respiratory disease, smoking habit, spirometry and surgical time. Multivariate logistic regression analysis were performed in order to evaluate the relationship between independent and dependent (POPC) variables. POPC incidence was 12.1%. By multivariate logistic regression analysis the variables increasing chance to POPC was cough with yellow mucus (OR= 3.8), thoracic surgery (OR=2.9) compared to abdominal surgery, BMI (OR=1.13), duration of smoking (OR=1.03) and prolonged duration of surgery (OR=1.007). In the thoracic surgery group, multivariate logistic regression analysis showed: wheezing (OR=6.2), BMI (OR=1.15), long time smoking (OR= 1.04) and prolonged duration of surgery (OR= 1.007) related to POPC. The variables occurrence that increased chance to POPC in thoracic and upper abdominal surgery were: cough with yellow mucus, thoracic surgery, BMI, duration of smoking and duration of surgery. Regarding the thoracic surgery group the significance variables were wheezing, BMI, duration of smoking and duration of surgery.

  16. 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

  17. Children at risk: 2. Risk Factors and Clinic Utilization

    DTIC Science & Technology

    1989-03-27

    health services utilization. develop more robust models of risk, and increase the effectiveness of our efforts directed towards prevention and...mental health services ( Tuckman and Regan, 1967; Novack it is vitally important that the various ways of measuring et al., 1975). Possibly, parental...related to clinic clinics than later-born children ( Tuckman and Regan, 1967). attrition have been conducted, it is not clear that such studies Possibly

  18. 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

  19. 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

  20. Clinical Governance: from clinical risk management to continuous quality improvement.

    PubMed

    Chiozza, Maria Laura; Plebani, Mario

    2006-01-01

    Reducing medical errors has become an international concern. Population-based studies from a number of nations around the world have consistently demonstrated unacceptably high rates of medical injury and preventable deaths. The introduction of effective reporting systems is a cornerstone of safe practice within hospitals and other healthcare organisations. Reporting can help to identify hazards and risks. However, reporting in itself does not improve safety. It is the response to reports that leads to change. Clinical teams must feel empowered to change the way in which they deliver their services, promoting effective clinical risk management. Process analysis, implementation of evidence-based practices, and a clear accountability system are effective tools not only for decreasing error rates, but also for improving effectiveness. Clinical Governance represents the context in which effective clinical risk management should be promoted and continuously improved. It should not be regarded as a separate activity, but should form part of the everyday practice of all healthcare professionals. It requires good multidisciplinary working and a willingness to reflect on and learn from errors to achieve a patient-centred and safer system.

  1. 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.

  2. Clinical Risk Factors for Portopulmonary Hypertension

    PubMed Central

    Kawut, Steven M.; Krowka, Michael J.; Trotter, James F.; Roberts, Kari E.; Benza, Raymond L.; Badesch, David B.; Taichman, Darren B.; Horn, Evelyn M.; Zacks, Steven; Kaplowitz, Neil; Brown, Robert S.; Fallon, Michael B.

    2010-01-01

    Portopulmonary hypertension affects up to 6% of patients with advanced liver disease, but the predictors and biologic mechanism for the development of this complication are unknown. We sought to determine the clinical risk factors for portopulmonary hypertension in patients with advanced liver disease. We performed a multicenter case-control study nested within a prospective cohort of patients with portal hypertension recruited from tertiary care centers. Cases had a mean pulmonary artery pressure >25 mm Hg, pulmonary vascular resistance >240 dynes · second · cm−5, and pulmonary capillary wedge pressure ≤ 15 mm Hg. Controls had a right ventricular systolic pressure < 40 mm Hg (if estimable) and normal right-sided cardiac morphology by transthoracic echocardiography. The study sample included 34 cases and 141 controls. Female sex was associated with a higher risk of portopulmonary hypertension than male sex (adjusted odds ratio =2.90, 95% confidence interval 1.20-7.01, P = 0.018). Autoimmune hepatitis was associated with an increased risk (adjusted odds ratio = 4.02, 95% confidence interval 1.14-14.23, P = 0.031), and hepatitis C infection was associated with a decreased risk (adjusted odds ratio =0.24, 95% confidence interval 0.09-0.65, P =0.005) of portopulmonary hypertension. The severity of liver disease was not related to the risk of portopulmonary hypertension. Conclusion Female sex and autoimmune hepatitis were associated with an increased risk of portopulmonary hypertension, whereas hepatitis C infection was associated with a decreased risk in patients with advanced liver disease. Hormonal and immunologic factors may therefore be integral to the development of portopulmonary hypertension. PMID:18537192

  3. 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.

  4. Clinical risk management of herb–drug interactions

    PubMed Central

    De Smet, Peter A G M

    2007-01-01

    The concomitant use of conventional and herbal medicines can lead to clinically relevant herb–drug interactions. Clinical risk management offers a systematic approach to minimize the untoward consequences of these interactions by paying attention to: (i) risk identification and assessment; (ii) development and execution of risk reduction strategies; and (iii) evaluation of risk reduction strategies. This paper reviews which steps should be explored or taken in these domains to improve the clinical risk management of adverse herb–drug interactions. PMID:17116126

  5. Ethnic difference of clinical vertebral fracture risk.

    PubMed

    Bow, C H; Cheung, E; Cheung, C L; Xiao, S M; Loong, C; Soong, C; Tan, K C; Luckey, M M; Cauley, J A; Fujiwara, S; Kung, A W C

    2012-03-01

    Vertebral fractures are the most common osteoporotic fractures. Data on the vertebral fracture risk in Asia remain sparse. This study observed that Hong Kong Chinese and Japanese populations have a less dramatic increase in hip fracture rates associated with age than Caucasians, but the vertebral fracture rates were higher, resulting in a high vertebral-to-hip fracture ratio. As a result, estimation of the absolute fracture risk for Asians may need to be readjusted for the higher clinical vertebral fracture rate. Vertebral fractures are the most common osteoporotic fractures. Data on the vertebral fracture risk in Asia remain sparse. The aim of this study was to report the incidence of clinical vertebral fractures among the Chinese and to compare the vertebral-to-hip fracture risk to other ethnic groups. Four thousand, three hundred eighty-six community-dwelling Southern Chinese subjects (2,302 women and 1,810 men) aged 50 or above were recruited in the Hong Kong Osteoporosis Study since 1995. Baseline demographic characteristics and medical history were obtained. Subjects were followed annually for fracture outcomes with a structured questionnaire and verified by the computerized patient information system of the Hospital Authority of the Hong Kong Government. Only non-traumatic incident hip fractures and clinical vertebral fractures that received medical attention were included in the analysis. The incidence rates of clinical vertebral fractures and hip fractures were determined and compared to the published data of Swedish Caucasian and Japanese populations. The mean age at baseline was 62 ± 8.2 years for women and 68 ± 10.3 years for men. The average duration of follow-up was 4.0 ± 2.8 (range, 1 to 14) years for a total of 14,733 person-years for the whole cohort. The incidence rate for vertebral fracture was 194/100,000 person-years in men and 508/100,000 person-years in women, respectively. For subjects above the age of 65, the clinical

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

    MedlinePlus

    ... Sponsors Why Are They Important How Do They Work Who Can Participate What To Expect During Benefits and Risks How They Protect Participants Finding Clinical Trials Links Children & Clinical Studies NHLBI Trials Clinical Trial Websites What Are the ...

  7. Reducing Risk with Clinical Decision Support

    PubMed Central

    Maloney, F.L.; Feblowitz, J.; Samal, L.; Sato, L.; Wright, A.

    2014-01-01

    Summary Objective Identify clinical opportunities to intervene to prevent a malpractice event and determine the proportion of malpractice claims potentially preventable by clinical decision support (CDS). Materials and Methods Cross-sectional review of closed malpractice claims over seven years from one malpractice insurance company and seven hospitals in the Boston area. For each event, clinical opportunities to intervene to avert the malpractice event and the presence or absence of CDS that might have a role in preventing the event, were assigned by a panel of expert raters. Compensation paid out to resolve a claim (indemnity), was associated with each CDS type. Results Of the 477 closed malpractice cases, 359 (75.3%) were categorized as substantiated and 195 (54%) had at least one opportunity to intervene. Common opportunities to intervene related to performance of procedure, diagnosis, and fall prevention. We identified at least one CDS type for 63% of substantiated claims. The 41 CDS types identified included clinically significant test result alerting, diagnostic decision support and electronic tracking of instruments. Cases with at least one associated intervention accounted for $40.3 million (58.9%) of indemnity. Discussion CDS systems and other forms of health information technology (HIT) are expected to improve quality of care, but their potential to mitigate risk had not previously been quantified. Our results suggest that, in addition to their known benefits for quality and safety, CDS systems within HIT have a potential role in decreasing malpractice payments. Conclusion More than half of malpractice events and over $40 million of indemnity were potentially preventable with CDS. PMID:25298814

  8. Emergency thoracic ultrasound and clinical risk management

    PubMed Central

    Interrigi, Maria Concetta; Trovato, Francesca M; Catalano, Daniela; Trovato, Guglielmo M

    2017-01-01

    Purpose Thoracic ultrasound (TUS) has been proposed as an easy-option replacement for chest X-ray (CXR) in emergency diagnosis of pneumonia, pleural effusion, and pneumothorax. We investigated CXR unforeseen diagnosis, subsequently investigated by TUS, considering its usefulness in clinical risk assessment and management and also assessing the sustainability of telementoring. Patients and methods This observational report includes a period of 6 months with proactive concurrent adjunctive TUS diagnosis telementoring, which was done using freely available smartphone applications for transfer of images and movies. Results Three hundred and seventy emergency TUS scans (excluding trauma patients) were performed and telementored. In 310 cases, no significant chest pathology was detected either by CXR, TUS, or the subsequent work-up; in 24 patients, there was full concordance between TUS and CXR (ten isolated pleural effusion; eleven pleural effusion with lung consolidations; and three lung consolidation without pleural effusion); in ten patients with lung consolidations, abnormalities identified by CXR were not detected by TUS. In 26 patients, only TUS diagnosis criteria of disease were present: in 19 patients, CXR was not diagnostic, ie, substantially negative, but TUS detected these conditions correctly, and these were later confirmed by computed tomography (CT). In seven patients, even if chest disease was identified by CXR, such diagnoses were significantly modified by ultrasound, and CT confirmed that TUS was more appropriate. The overall respective individual performances of CXR and TUS for the diagnosis of a pleural–pulmonary disease in emergency are good, with accuracy >95%. Conclusion About 20% of pneumonia cases were detectable only by CXR and 20% only by TUS and not by CXR; ie, about 40% of patients may have been misdiagnosed if, by chance, only one of the two tools had been used. The concurrent use of TUS and CXR increases the overall sensitivity and

  9. Clinical risk factors and periventricular leucomalacia.

    PubMed

    Trounce, J Q; Shaw, D E; Levene, M I; Rutter, N

    1988-01-01

    Two hundred infants of below 1501 g at birth were regularly examined with real time ultrasound using a 7.5 MHz transducer. Abnormalities were categorized as periventricular haemorrhage (PVH) (n = 107) or periventricular leucomalacia (PVL), with or without PVH (n = 52). Of the group with PVL, 25 had the appearances of prolonged flare without cavitation. Prospective assessments of up to 50 potential clinical risk factors were made wherever possible on each infant including stratification of all blood gas and systolic blood pressure data. Multivariate logistic regression analyses confirmed a strong correlation between immaturity and PVH but this was not found in cases of PVL. Independent variables associated with PVL included pneumothorax, maximum bilirubin concentration, surgery, and the proportion of time the infant's PaCO2 remained above 7 kPa. There was a very strong inverse correlation between anaemia and PVL. Systolic blood pressure data were carefully analysed and there was no relation between either hypotension or antepartum haemorrhage and the development of PVL.

  10. 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.

  11. Risk and the physics of clinical prediction.

    PubMed

    McEvoy, John W; Diamond, George A; Detrano, Robert C; Kaul, Sanjay; Blaha, Michael J; Blumenthal, Roger S; Jones, Steven R

    2014-04-15

    The current paradigm of primary prevention in cardiology uses traditional risk factors to estimate future cardiovascular risk. These risk estimates are based on prediction models derived from prospective cohort studies and are incorporated into guideline-based initiation algorithms for commonly used preventive pharmacologic treatments, such as aspirin and statins. However, risk estimates are more accurate for populations of similar patients than they are for any individual patient. It may be hazardous to presume that the point estimate of risk derived from a population model represents the most accurate estimate for a given patient. In this review, we exploit principles derived from physics as a metaphor for the distinction between predictions regarding populations versus patients. We identify the following: (1) predictions of risk are accurate at the level of populations but do not translate directly to patients, (2) perfect accuracy of individual risk estimation is unobtainable even with the addition of multiple novel risk factors, and (3) direct measurement of subclinical disease (screening) affords far greater certainty regarding the personalized treatment of patients, whereas risk estimates often remain uncertain for patients. In conclusion, shifting our focus from prediction of events to detection of disease could improve personalized decision-making and outcomes. We also discuss innovative future strategies for risk estimation and treatment allocation in preventive cardiology. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. Clinical options for women at high risk for breast cancer.

    PubMed

    Hartmann, L C; Sellers, T A; Schaid, D J; Nayfield, S; Grant, C S; Bjoraker, J A; Woods, J; Couch, F

    1999-10-01

    Women at hereditary risk of breast cancer face a difficult clinical decision. Each of the options available to them has unique advantages and disadvantages that are summarized in Table 9. Many components enter a high-risk woman's decision: her objective risk of breast cancer; clinical features, such as the consistency of breast tissue and resultant ease of examination; breast density on mammography; personal characteristics, including her experience with cancer within her family; her role and [table: see text] responsibilities within her own nuclear family; her values and goals; her experiences with the medical system; and her subjective assessment of risk. It is generally believed that women significantly overestimate their risk of breast cancer. Thus, it is vital that a woman at risk have access to a genetic counselor who can provide accurate assessment of her risk. Women should be encouraged to take time to understand their risk level and the advantages and disadvantages of the options before them.

  13. 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.

  14. Stroke Risk Perception in Atrial Fibrillation Patients is not Associated with Clinical Stroke Risk.

    PubMed

    Fournaise, Anders; Skov, Jane; Bladbjerg, Else-Marie; Leppin, Anja

    2015-11-01

    Clinical risk stratification models, such as the CHA2DS2-VASc, are used to assess stroke risk in atrial fibrillation (AF) patients. No study has yet investigated whether and to which extent these patients have a realistic perception of their personal stroke risk. The purpose of this study was to investigate and describe the association between AF patients' stroke risk perception and clinical stroke risk. In an observational cross-sectional study design, we surveyed 178 AF patients with a mean age of 70.6 years (SD 8.3) in stable anticoagulant treatment (65% treatment duration >12 months). Clinical stroke risk was scored through the CHA2DS2-VASc, and patients rated their perceived personal stroke risk on a 7-point Likert scale. There was no significant association between clinical stroke risk assessment and patients' stroke risk perception (rho = .025; P = .741). Approximately 60% of the high-risk patients had an unrealistic perception of their own stroke risk, and there was no significant increase in risk perception from those with a lower compared with a higher risk factor load (χ(2) = .010; P = .522). Considering possible negative implications in terms of lack of motivation for lifestyle behavior change and adequate adherence to the treatment and monitoring of vitamin K antagonist, the apparent underestimation of risk by large subgroups warrants attention and needs further investigation with regard to possible behavioral consequences. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  15. Risk disclosure and preclinical Alzheimer's disease clinical trial enrollment.

    PubMed

    Grill, Joshua D; Karlawish, Jason; Elashoff, David; Vickrey, Barbara G

    2013-05-01

    To identify the facilitators and barriers to preclinical Alzheimer's disease (AD) clinical trial recruitment, 50 cognitively normal participants were interviewed after being randomized to one of two hypothetical AD risk scenarios: (1) the general age-related risk for AD, or (2) being at 50% increased risk for AD. Participants provided uncued barriers and facilitators to the hypothetical decision of whether they would enroll. Thirteen themes of facilitators and five themes of barriers were identified. The most common barrier was fear related to taking study drug. Those randomized to being at increased risk for AD more frequently cited lowering personal risk as a facilitator (P = .01) and less frequently cited time as a barrier to enrollment (P = .02). These results suggest potential challenges to preclinical AD clinical trial recruitment and that disclosing risk information may enhance enrollment. Copyright © 2013 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  18. Clinical features of drug abuse that reflect genetic risk

    PubMed Central

    Kendler, K. S.; Ohlsson, H.; Sundquist, K.; Sundquist, J.

    2014-01-01

    Background Drug abuse (DA) is a clinically heterogeneous syndrome. Can we, in a large epidemiological sample, identify clinical features of DA cases that index genetic risk? Method Using registration in medical, legal or pharmacy records, we identified four kinds of relative pairs (n =935854) starting with a proband with DA: monozygotic co-twins; full siblings; half-siblings; and cousins. Using linear hazard regression, we examined the interaction between three clinical features of DA in the proband and risk for DA in these four relative pairs, ordered by degree of genetic relationship. Results Increased risk for DA in relatives was robustly predicted by early age at first registration, total number of registrations, and ascertainment in the criminal versus the medical or pharmacy registry. In multivariate models, all three of these variables remained significant and in aggregate strongly predicted DA risk in relatives. The risk for DA in siblings of DA probands in the highest decile of genetic risk predicted by our three indices was more than twice as great as that predicted in siblings of probands in the lowest decile of risk. Conclusions In an epidemiological sample, genetic risk for DA can be substantially indexed by simple clinical and historical variables. PMID:24461082

  19. 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

  20. [Clinical risk management in german hospitals - does size really matter?].

    PubMed

    Bohnet-Joschko, S; Jandeck, L M; Zippel, C; Andersen, M; Krummenauer, F

    2011-06-01

    In the last years, German hospitals have implemented different measures to increase patient safety. Special importance has been attached to near miss reporting systems (critical incident reporting system, CIRS) as instruments for risk identification in health care, instruments that promise high potential for organisational learning. To gain insight into the current status of critical incident reporting systems and other instruments for clinical risk management, a survey among 341 hospitals was carried out in 2009. Questions covered a process of six steps: from risk strategy to methods for risk identification, to risk analysis and risk assessment, to risk controlling and risk monitoring. Structured telephone interviews were conducted with 341 German hospitals, featuring in their statutory quality reports certain predefined key terms that indicated the concluded or planned implementation of clinical risk management. The main objective of those interviews was to check the relation between status/organisation of self-reported risk management and both operator (private, public, NPO) and size of hospital. The implementation of near miss reporting systems (CIRS) in German hospitals has been constantly rising since 2004: in 2009, 54 % of the interviewed hospitals reported an implemented CIRS; of these, 72 % reported the system to be hospital-wide. An association between CIRS and private, public or NPO-operator could not be detected (Fisher p = 1.000); however, the degree of CIRS implementation was significantly increasing with the size of the hospital, i.e., the number of beds (Fisher p = 0.008): only 38 % of the hospitals with less than 100 beds reported CIRS implementation against 52 % of those between 100 to 500 beds, and 67 % of those with more than 500 beds. While 62 % of the hospitals interviewed reported the maintenance of a risk management committee, only 14 % reported the implementation of risk analysing techniques. As to clinical risk

  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. Enhanced clinical pharmacy service targeting tools: risk-predictive algorithms.

    PubMed

    El Hajji, Feras W D; Scullin, Claire; Scott, Michael G; McElnay, James C

    2015-04-01

    This study aimed to determine the value of using a mix of clinical pharmacy data and routine hospital admission spell data in the development of predictive algorithms. Exploration of risk factors in hospitalized patients, together with the targeting strategies devised, will enable the prioritization of clinical pharmacy services to optimize patient outcomes. Predictive algorithms were developed using a number of detailed steps using a 75% sample of integrated medicines management (IMM) patients, and validated using the remaining 25%. IMM patients receive targeted clinical pharmacy input throughout their hospital stay. The algorithms were applied to the validation sample, and predicted risk probability was generated for each patient from the coefficients. Risk threshold for the algorithms were determined by identifying the cut-off points of risk scores at which the algorithm would have the highest discriminative performance. Clinical pharmacy staffing levels were obtained from the pharmacy department staffing database. Numbers of previous emergency admissions and admission medicines together with age-adjusted co-morbidity and diuretic receipt formed a 12-month post-discharge and/or readmission risk algorithm. Age-adjusted co-morbidity proved to be the best index to predict mortality. Increased numbers of clinical pharmacy staff at ward level was correlated with a reduction in risk-adjusted mortality index (RAMI). Algorithms created were valid in predicting risk of in-hospital and post-discharge mortality and risk of hospital readmission 3, 6 and 12 months post-discharge. The provision of ward-based clinical pharmacy services is a key component to reducing RAMI and enabling the full benefits of pharmacy input to patient care to be realized. © 2014 John Wiley & Sons, Ltd.

  3. Clinical benefits and risks of bilateral amplification.

    PubMed

    Walden, Therese C

    2006-01-01

    Clinicians are in the unique position of continually developing a foundation of evidence-based practice each time they evaluate a patient. This is true not only in the field of audiology, but also in all healthcare professions. Typically, evidence-based practice (EBP) is assimilated from a combination of a systematic review of current practices, practitioner experience, academic training and ongoing continuing education through review of journals, textbooks and attendance at meetings as well as informal discussions with colleagues. Clinicians are inundated with information from these sources, and they need to extract the necessary information and apply it to their specific patient population. Evidence-based practice as it applies to the non-medical treatment of hearing loss (with hearing aids) will be discussed. In addition, several studies based on clinical observations are presented for discussion.

  4. Predicting reattendance at a high-risk breast cancer clinic.

    PubMed

    Ormseth, Sarah R; Wellisch, David K; Aréchiga, Adam E; Draper, Taylor L

    2015-10-01

    The research about follow-up patterns of women attending high-risk breast-cancer clinics is sparse. This study sought to profile daughters of breast-cancer patients who are likely to return versus those unlikely to return for follow-up care in a high-risk clinic. Our investigation included 131 patients attending the UCLA Revlon Breast Center High Risk Clinic. Predictor variables included age, computed breast-cancer risk, participants' perceived personal risk, clinically significant depressive symptomatology (CES-D score ≥ 16), current level of anxiety (State-Trait Anxiety Inventory), and survival status of participants' mothers (survived or passed away from breast cancer). A greater likelihood of reattendance was associated with older age (adjusted odds ratio [AOR] = 1.07, p = 0.004), computed breast-cancer risk (AOR = 1.10, p = 0.017), absence of depressive symptomatology (AOR = 0.25, p = 0.009), past psychiatric diagnosis (AOR = 3.14, p = 0.029), and maternal loss to breast cancer (AOR = 2.59, p = 0.034). Also, an interaction was found between mother's survival and perceived risk (p = 0.019), such that reattendance was associated with higher perceived risk among participants whose mothers survived (AOR = 1.04, p = 0.002), but not those whose mothers died (AOR = 0.99, p = 0.685). Furthermore, a nonlinear inverted "U" relationship was observed between state anxiety and reattendance (p = 0.037); participants with moderate anxiety were more likely to reattend than those with low or high anxiety levels. Demographic, medical, and psychosocial factors were found to be independently associated with reattendance to a high-risk breast-cancer clinic. Explication of the profiles of women who may or may not reattend may serve to inform the development and implementation of interventions to increase the likelihood of follow-up care.

  5. Risk factors for clinical endometritis in postpartum dairy cattle.

    PubMed

    Potter, Timothy J; Guitian, Javier; Fishwick, John; Gordon, Patrick J; Sheldon, I Martin

    2010-07-01

    Bacterial contamination of the uterine lumen after parturition occurs in most dairy cattle. The presence of clinical endometritis beyond three weeks post partum depends on the balance between microbes, host immunity, and other environmental or animal factors. The present study tested the hypothesis that clinical endometritis is associated with animal factors, such as retained fetal membranes, assisted calving and twins, as well as fecal contamination of the environment. The association between selected risk factors and the lactational incidence risk of clinical endometritis was examined in 293 animals from four dairy herds. Multivariate analysis was used to identify risk factors and quantify their relative risk (RR) and population attributable fraction (PAF) based on the proportion of cows exposed to each factor. The lactational incidence of clinical endometritis was 27% and significant risk factors for clinical endometritis were retained fetal membranes (RR=3.6), assisted calving (RR=1.7), stillbirth (RR=3.1), vulval angle (RR=1.3), primparity (RR=1.8), and male offspring (RR=1.5) but not the cleanliness of the environment or the animal. The highest PAF was associated with male offspring (0.6) so the use of sexed semen has the greatest potential to reduce the incidence of clinical endometritis. The dominant association between retained fetal membranes and clinical endometritis was supported by an expert panel of clinicians. The risk factors for clinical endometritis appear to be associated with trauma of the female genital tract and disruption of the physical barriers to infection rather than fecal contamination.

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

    PubMed

    Clark, Matthew

    2015-04-01

    This study examines the ability of nonclinical adverse event observations to predict human clinical adverse events observed in drug development programs. In addition it examines the relationship between nonclinical and clinical adverse event observations to drug withdrawal and proposes a model to predict drug withdrawal based on these observations. These analyses provide risk assessments useful for both planning patient safety programs, as well as a statistical framework for assessing the future success of drug programs based on nonclinical and clinical observations. Bayesian analyses were undertaken to investigate the connection between nonclinical adverse event observations and observations of that same event in clinical trial for a large set of approved drugs. We employed the same statistical methods used to evaluate the efficacy of diagnostic tests to evaluate the ability of nonclinical studies to predict adverse events in clinical studies, and adverse events in both to predict drug withdrawal. We find that some nonclinical observations suggest higher risk for observing the same adverse event in clinical studies, particularly arrhythmias, QT prolongation, and abnormal hepatic function. However the lack of these events in nonclinical studies is found to not be a good predictor of safety in humans. Some nonclinical and clinical observations appear to be associated with high risk of drug withdrawal from market, especially arrhythmia and hepatic necrosis. We use the method to estimate the overall risk of drug withdrawal from market using the product of the risks from each nonclinical and clinical observation to create a risk profile. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. 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.

  8. Clinical risk in rehabilitation: an exploratory investigation in Campania region.

    PubMed

    Corrado, B; Di Meglio, C; Montuori, P

    2014-01-01

    Clinical risk management is a comprehensive programme that encompasses all the measures implemented to improve the quality of the healthcare service and ensure patient safety, which is based on learning through error. This process is intended to bring about ongoing improvements in clinical practice, starting with risk identification, before moving on to risk assessment and analysis, in order to reduce risks where possible. When clinical risk management is applied in rehabilitation, the first step involves identifying errors by assessing adverse events, which are considered to indicate the existing risk. Our work aims to explore the characteristics of the clinical risk in rehabilitation so as to learn more about its extent, its components, and its implications for the user. Our study involved numerous workers operating in four different branches of rehabilitation - speech therapy, physiotherapy, psychomotor education and occupational therapy - at forty-nine private rehabilitation centres in the province of Naples, an area that has not been studied before. A questionnaire was drafted regarding the main errors committed in the rehabilitation sector. It was then distributed and collected in again, after which the results were analysed and outcomes measured. Out of a total of 556 questionnaires distributed, 493 were returned (88.6% response rate.). The study revealed that for all the rehabilitation branches considered, the macro-category of errors linked to technical and professional aspects accounted for the highest percentage of the total errors (39%). In this study, the most frequent errors linked to technical and professional aspects were: wrong dose errors, treatment planning errors and functional assessment errors. There is an evident need to take action in order to manage the clinical risk in rehabilitation: to promote a concept of errors as opportunities for learning and improvement; to maintain the focus on both individual responsibility and on any systemic

  9. 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

  10. 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

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

    PubMed

    Neumann, Stefan

    2015-01-01

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

  12. Beyond human subjects: risk, ethics, and clinical development of nanomedicines.

    PubMed

    Kimmelman, Jonathan

    2012-01-01

    Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena.

  13. Clinical implications of genomics for cancer risk genetics.

    PubMed

    Thomas, David M; James, Paul A; Ballinger, Mandy L

    2015-06-01

    The study of human genetics has provided substantial insight into cancer biology. With an increase in sequencing capacity and a reduction in sequencing costs, genomics will probably transform clinical cancer genetics. A heritable basis for many cancers is accepted, but so far less than half the genetic drivers have been identified. Genomics will increasingly be applied to populations irrespective of family history, which will change the framework of phenotype-directed genetic testing. Panel testing and whole genome sequencing will identify novel, polygenic, and de-novo determinants of cancer risk, often with lower penetrance, which will challenge present binary clinical classification systems and management algorithms. In the future, genotype-stratified public screening and prevention programmes could form part of tailored population risk management. The integration of research with clinical practice will result in so-called discovery cohorts that will help identify clinically significant genetic variation.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

  16. The management of clinical risk in telemedicine applications.

    PubMed

    Darkins, A

    1996-01-01

    Any telemedicine application should be viewed in terms of its health-care context, the clinical process it is enabling, and whether it is appropriate to apply telemedicine to that process. Telemedicine should be used as a tool to enable the transfer of clinical information which, by being transferred, will reduce clinical risks. Because managing clinical services involves knowing where clinical decisions are being made, it is important to ensure that telemedicine activity is recorded as part of the routine clinical and investigative data sets that will be kept for clinical audit and health-service costing purposes. There may be areas of health-care delivery where the telemedicine solution becomes the treatment of choice. In this event, not to provide telemedicine may be unethical and may expose a service to high clinical risk. If a service is based on the use of telemedicine, it is important to ensure that the technical specifications are adequate, that the system is sufficiently reliable, and that there are adequate back-up provisions in the case of system failure.

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

    PubMed

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

    2006-01-01

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

  18. Clinical Risk Factors for Infective Endocarditis in Staphylococcus aureus Bacteremia

    PubMed Central

    Chapagain, Bikash; Joshi, Astha; Brennessel, Debra J.

    2017-01-01

    Crucial to the management of staphylococcal bacteremia is an accurate evaluation of associated endocarditis, which has both therapeutic and prognostic implications. Because the clinical presentation of endocarditis can be nonspecific, the judicious use of echocardiography is important in distinguishing patients at high risk of developing endocarditis. In the presence of high-risk clinical features, an early transesophageal echocardiogram is warranted without prior transthoracic echocardiography. The purpose of this study was to investigate the clinical risk factors for staphylococcal infective endocarditis that might warrant earlier transesophageal echocardiography and to describe the incidence of endocarditis in cases of methicillin-resistant and methicillin-sensitive Staphylococcus aureus bacteremia. A retrospective case-control study was conducted by means of chart review of 91 patients consecutively admitted to a community hospital from January 2009 through January 2013. Clinical risk factors of patients with staphylococcal bacteremia were compared with risk factors of patients who had definite diagnoses of infective endocarditis. There were 69 patients with bacteremia alone (76%) and 22 patients with endocarditis (24%), as verified by echocardiography. Univariate analysis showed that diabetes mellitus (P=0.024), the presence of an automatic implantable cardioverter-defibrillator/pacemaker (P=0.006) or a prosthetic heart valve (P=0.003), and recent hospitalization (P=0.048) were significantly associated with developing infective endocarditis in patients with S. aureus bacteremia. The incidence of methicillin-resistant and methicillin-sensitive S. aureus bacteremia was similar in the bacteremia and infective-endocarditis groups (P=0.437). In conclusion, identified high-risk clinical factors in the presence of bacteremia can suggest infective endocarditis. Early evaluation with transesophageal echocardiography might well be warranted. PMID:28265207

  19. Cerebrovascular risk factors and clinical classification of strokes.

    PubMed

    Pinto, Antonio; Tuttolomondo, Antonino; Di Raimondo, Domenico; Fernandez, Paola; Licata, Giuseppe

    2004-08-01

    Cerebrovascular risk represents a progressive and evolving concept owing to the particular distribution of risk factors in patients with ischemic stroke and in light of the newest stroke subtype classifications that account for pathophysiological, instrumental, and clinical criteria. Age represents the strongest nonmodifiable risk factor associated with ischemic stroke, while hypertension constitutes the most important modifiable cerebrovascular risk factor, confirmed by a host of epidemiological data and by more recent intervention trials of primary (HOT, Syst-Eur, LIFE) and secondary (PROGRESS) prevention of stroke in hypertensive patients. To be sure, a curious relationship exists between stroke and diabetes. Although the Framingham Study, The Honolulu Heart Program, and a series of Finnish studies reported a linear relationship between improved glucose metabolism and cerebral ischemia, the clinical and prognostic profile of diabetic patients with ischemic stroke remains to be fully understood. Our group, on the basis of TOAST classification--a diagnostic classification of ischemic stroke developed in 1993 that distinguishes five different clinical subtypes of ischemic stroke: large-artery atherosclerosis (LAAS), cardioembolic infarct (CEI), lacunar infarct (LAC), stroke of other determined origin (ODE), and stroke of undetermined origin (UDE), and now extensively used in clinical and scientific context--analysed the prevalence of cerebrovascular risk factors and the distribution of TOAST subtypes in more 300 patients with acute ischemic stroke in two consecutives studies that reported the significant association between diabetes and the lacunar subtype and a better clinical outcome for diabetic patients, most likely related to the higher prevalence of the lacunar subtype. Well-confirmed are the roles of cigarette smoking, atrial fibrillation, and asymptomatic carotid stenosis as cerebrovascular risk factors. Particularly interesting seems to be the function of

  20. [Risk assessment for clinical external application of calomel].

    PubMed

    Qiu, Heng; Wang, Qi

    2015-07-01

    Calomel is a common traditional Chinese medicine (TCM) containing mercury in clinical external application. Although the toxicity of calomel has attracted concern, there is no unified standard yet in clinical external application. Risk assessment is used for evaluating the potential health effects of hazardous substances. The purpose of this article was to evaluate the health risk of calomel in clinical external application on the basis of toxicity data, to ensure safe and rational application of TCM containing calomel. The toxicity data of transdermal administration of calomel or mercurous chloride were collected by searching the literature. The daily maximum exposure dosage of calomel in clinical external application was estimated by following the four procedures of risk assessment, and Margin of Safety (MOS) as an evaluation indicator was then calculated to evaluate the safety of calomel on clinical application. It has been reported that the adult in single transdermal administration of calomel at 1. 5 g was lethal. Based on the LOAEL of calomel for long-term transdermal exposure (1 month) in rats was 0.096 g · kg(-1) · d(-1), the NOAEL of calomel for patients (about 60 kg) by external application within 2 weeks was estimated to be 1.46 mg · kg(-1) · d(-1). When MOS value equals to 1, the daily maximum exposure of calomel in clinical external application within 2 weeks was calculated to be 1.1 g. The results suggest that daily single dose of calomel in clinical external application should be lower than 1.5 g for adults, and more attention should be paid to changes in hepatic and renal function of patients when repeated dose more than 1.1 g within 2 weeks. The approach of risk assessment could be helpful in rational application of TCM containing mercury.

  1. Risk assessment and clinical decision making for colorectal cancer screening.

    PubMed

    Schroy, Paul C; Caron, Sarah E; Sherman, Bonnie J; Heeren, Timothy C; Battaglia, Tracy A

    2015-10-01

    Shared decision making (SDM) related to test preference has been advocated as a potentially effective strategy for increasing adherence to colorectal cancer (CRC) screening, yet primary care providers (PCPs) are often reluctant to comply with patient preferences if they differ from their own. Risk stratification advanced colorectal neoplasia (ACN) provides a rational strategy for reconciling these differences. To assess the importance of risk stratification in PCP decision making related to test preference for average-risk patients and receptivity to use of an electronic risk assessment tool for ACN to facilitate SDM. Mixed methods, including qualitative key informant interviews and a cross-sectional survey. PCPs at an urban, academic safety-net institution. Screening preferences, factors influencing patient recommendations and receptivity to use of a risk stratification tool. Nine PCPs participated in interviews and 57 completed the survey. Despite an overwhelming preference for colonoscopy by 95% of respondents, patient risk (67%) and patient preferences (63%) were more influential in their decision making than patient comorbidities (31%; P < 0.001). Age was the single most influential risk factor (excluding family history), with <20% of respondents choosing factors other than age. Most respondents reported that they would be likely to use a risk stratification tool in their practice either 'often' (43%) or sometimes (53%). Risk stratification was perceived to be important in clinical decision making, yet few providers considered risk factors other than age for average-risk patients. Providers were receptive to the use of a risk assessment tool for ACN when recommending an appropriate screening test for select patients. © 2013 John Wiley & Sons Ltd.

  2. 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)

  3. Computerized Ultrasound Risk Evaluation (CURE): First Clinical Results

    NASA Astrophysics Data System (ADS)

    Duric, N.; Littrup, P.; Rama, O.; Holsapple, E.

    The Karmanos Cancer Institute has developed an ultrasound (US) tomography system, known as Computerized Ultrasound Risk Evaluation (CURE), for detecting and evaluating breast cancer, with the eventual goal of providing improved differentiation of benign masses from cancer. We report on our first clinical findings with CURE.

  4. 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

  5. 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)

  6. 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.

  7. Person-Centered Fall Risk Awareness Perspectives: Clinical Correlates and Fall Risk.

    PubMed

    Verghese, Joe

    2016-12-01

    To identify clinical correlates of person-centered fall risk awareness and their validity for predicting falls. Prospective cohort study. Community. Ambulatory community-dwelling older adults without dementia (N = 316; mean age 78, 55% female). Fall risk awareness was assessed using a two-item questionnaire that asked participants about overall likelihood of someone in their age group having a fall and their own personal risk of falling over the next 12 months. Incident falls were recorded over study follow-up. Fifty-three participants (16.8%) responded positively to the first fall risk awareness question about being likely to have a fall in the next 12 months, and 100 (31.6%) reported being at personal risk of falling over the next 12 months. There was only fair correlation (κ = 0.370) between responses on the two questions. Prior falls and depressive symptoms were associated with positive responses on both fall risk awareness questions. Age and other established fall risk factors were not associated with responses on either fall risk awareness question. The fall risk awareness questionnaire did not predict incident falls or injurious falls. Fall risk awareness is low in older adults. Although person-centered fall risk awareness is not predictive of falls, subjective risk perceptions should be considered when designing fall preventive strategies because they may influence participation and behaviors. © 2016, Copyright the Author Journal compilation © 2016, The American Geriatrics Society.

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

    PubMed

    Wadlund, Jill; Platt, Leslie A

    2002-01-01

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

  9. Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators

    PubMed Central

    Hardy, Judy; Yee, Raymond; Healey, Jeffrey S.; Birnie, David; Simpson, Christopher S.; Crystal, Eugene; Mangat, Iqwal; Nanthakumar, Kumaraswamy; Wang, Xuesong; Krahn, Andrew D.; Dorian, Paul; Austin, Peter C.; Tu, Jack V.

    2015-01-01

    Background— A conceptualized model may be useful for understanding risk stratification of primary prevention implantable cardioverter defibrillators considering the competing risks of appropriate implantable cardioverter defibrillator shock versus mortality. Methods and Results— In a prospective, multicenter, population-based cohort with left ventricular ejection fraction ≤35% referred for primary prevention implantable cardioverter defibrillator, we developed dual risk stratification models to determine the competing risks of appropriate defibrillator shock versus mortality using a Fine-Gray subdistribution hazard model. Among 7020 patients referred, 3445 underwent defibrillator implant (79.7% men, median, 66 years [25th, 75th: 58–73]). During 5918 person-years of follow-up, appropriate shock occurred in 204 patients (3.6 shocks/100 person-years) and 292 died (4.9 deaths/100 person-years). Competing risk predictors of appropriate shock included nonsustained ventricular tachycardia, atrial fibrillation, serum creatinine concentration, digoxin or amiodarone use, and QRS duration near 130-ms peak. One-year cumulative incidence of appropriate shock was 0.9% in the lowest risk category, and 1.7%, 2.5%, 4.9%, and 9.3% in low, intermediate, high, and highest risk groups, respectively. Hazard ratios for appropriate shock ranged from 4.04 to 7.79 in the highest 3 deciles (all P≤0.001 versus lowest risk). Cumulative incidence of 1-year death was 0.6%, 1.9%, 3.3%, 6.2%, and 17.7% in lowest, low, intermediate, high, and highest risk groups, respectively. Mortality hazard ratios ranged from 11.48 to 36.22 in the highest 3 deciles (all P<0.001 versus lowest risk). Conclusions— Simultaneous estimation of risks of appropriate shock and mortality can be performed using clinical variables, providing a potential framework for identification of patients who are unlikely to benefit from prophylactic implantable cardioverter defibrillator. PMID:26224792

  10. Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators.

    PubMed

    Lee, Douglas S; Hardy, Judy; Yee, Raymond; Healey, Jeffrey S; Birnie, David; Simpson, Christopher S; Crystal, Eugene; Mangat, Iqwal; Nanthakumar, Kumaraswamy; Wang, Xuesong; Krahn, Andrew D; Dorian, Paul; Austin, Peter C; Tu, Jack V

    2015-09-01

    A conceptualized model may be useful for understanding risk stratification of primary prevention implantable cardioverter defibrillators considering the competing risks of appropriate implantable cardioverter defibrillator shock versus mortality. In a prospective, multicenter, population-based cohort with left ventricular ejection fraction ≤35% referred for primary prevention implantable cardioverter defibrillator, we developed dual risk stratification models to determine the competing risks of appropriate defibrillator shock versus mortality using a Fine-Gray subdistribution hazard model. Among 7020 patients referred, 3445 underwent defibrillator implant (79.7% men, median, 66 years [25th, 75th: 58-73]). During 5918 person-years of follow-up, appropriate shock occurred in 204 patients (3.6 shocks/100 person-years) and 292 died (4.9 deaths/100 person-years). Competing risk predictors of appropriate shock included nonsustained ventricular tachycardia, atrial fibrillation, serum creatinine concentration, digoxin or amiodarone use, and QRS duration near 130-ms peak. One-year cumulative incidence of appropriate shock was 0.9% in the lowest risk category, and 1.7%, 2.5%, 4.9%, and 9.3% in low, intermediate, high, and highest risk groups, respectively. Hazard ratios for appropriate shock ranged from 4.04 to 7.79 in the highest 3 deciles (all P≤0.001 versus lowest risk). Cumulative incidence of 1-year death was 0.6%, 1.9%, 3.3%, 6.2%, and 17.7% in lowest, low, intermediate, high, and highest risk groups, respectively. Mortality hazard ratios ranged from 11.48 to 36.22 in the highest 3 deciles (all P<0.001 versus lowest risk). Simultaneous estimation of risks of appropriate shock and mortality can be performed using clinical variables, providing a potential framework for identification of patients who are unlikely to benefit from prophylactic implantable cardioverter defibrillator. © 2015 The Authors.

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

    PubMed Central

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

    2011-01-01

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

  12. Clinical risk management approach for long-duration space missions.

    PubMed

    Gray, Gary W; Sargsyan, Ashot E; Davis, Jeffrey R

    2010-12-01

    In the process of crewmember evaluation and certification for long-duration orbital missions, the International Space Station (ISS) Multilateral Space Medicine Board (MSMB) encounters a surprisingly wide spectrum of clinical problems. Some of these conditions are identified within the ISS Medical Standards as requiring special consideration, or as falling outside the consensus Medical Standards promulgated for the ISS program. To assess the suitability for long-duration missions on ISS for individuals with medical problems that fall outside of standards or are otherwise of significant concern, the MSMB has developed a risk matrix approach to assess the risks to the individual, the mission, and the program. The goal of this risk assessment is to provide a more objective, evidence- and risk-based approach for aeromedical disposition. Using a 4 x 4 risk matrix, the probability of an event is plotted against the potential impact. Event probability is derived from a detailed review of clinical and aerospace literature, and based on the best available evidence. The event impact (consequences) is assessed and assigned within the matrix. The result has been a refinement of MSMB case assessment based on evidence-based data incorporated into a risk stratification process. This has encouraged an objective assessment of risk and, in some cases, has resulted in recertification of crewmembers with medical conditions which hitherto would likely have been disqualifying. This paper describes a risk matrix approach developed for MSMB disposition decisions. Such an approach promotes objective, evidence-based decision-making and is broadly applicable within the aerospace medicine community.

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

    PubMed

    Corcoran, David; Grant, Patrick; Berry, Colin

    2015-09-01

    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.

  14. Development of the SaFETy Score: A Clinical Screening Tool for Predicting Future Firearm Violence Risk.

    PubMed

    Goldstick, Jason E; Carter, Patrick M; Walton, Maureen A; Dahlberg, Linda L; Sumner, Steven A; Zimmerman, Marc A; Cunningham, Rebecca M

    2017-05-16

    Interpersonal firearm violence among youth is a substantial public health problem, and emergency department (ED) physicians require a clinical screening tool to identify high-risk youth. To derive a clinically feasible risk index for firearm violence. 24-month prospective cohort study. Urban, level 1 ED. Substance-using youths, aged 14 to 24 years, seeking ED care for an assault-related injury and a proportionately sampled group of non-assault-injured youth enrolled from September 2009 through December 2011. Firearm violence (victimization/perpetration) and validated questionnaire items. A total of 599 youths were enrolled, and presence/absence of future firearm violence during follow-up could be ascertained in 483 (52.2% were positive). The sample was randomly split into training (75%) and post-score-construction validation (25%) sets. Using elastic-net penalized logistic regression, 118 baseline predictors were jointly analyzed; the most predictive variables fell predominantly into 4 domains: violence victimization, community exposure, peer influences, and fighting. By selection of 1 item from each domain, the 10-point SaFETy (Serious fighting, Friend weapon carrying, community Environment, and firearm Threats) score was derived. SaFETy was associated with firearm violence in the validation set (odds ratio [OR], 1.47 [95% CI, 1.23 to 1.79]); this association remained (OR, 1.44 [CI, 1.20 to 1.76]) after adjustment for reason for ED visit. In 5 risk strata observed in the training data, firearm violence rates in the validation set were 18.2% (2 of 11), 40.0% (18 of 45), 55.8% (24 of 43), 81.3% (13 of 16), and 100.0% (6 of 6), respectively. The study was conducted in a single ED and involved substance-using youths. SaFETy was not externally validated. The SaFETy score is a 4-item score based on clinically feasible questionnaire items and is associated with firearm violence. Although broader validation is required, SaFETy shows potential to guide resource allocation

  15. Developing performance indicators for clinical governance in dimensions of risk management and clinical effectiveness.

    PubMed

    Azami-Aghdash, Saber; Tabrizi, Jafar Sadegh; Sadeghi-Bazargani, Homayoun; Hajebrahimi, Sakineh; Naghavi-Behzad, Mohammad

    2015-04-01

    This study has been designed and conducted to develop domestic indicators for evaluating the performance of clinical governance in dimensions of risk management and clinical effectiveness. This study implemented a 5-stage process including conducting a comprehensive literature review, expert panel (∼ 1000 h per person per session, 11 experts), semi-structured interviews, a 2-round Delphi study (33 experts were in attendance) and a final expert panel (8 experts were in attendance). East Azerbaijan-Iran Province. Fifty-six specialists and experts in different fields of medical sciences. Importance and applicability of indicators. Using a thorough literature review, 361 indicators (129 risk management indicators in 4 dimensions and 232 clinical effectiveness indicators in 18 dimensions) were found. After conducting expert panels and interviews, the number of indicators decreased to 168 cases (65 risk management indicators in 4 dimensions and 103 clinical effectiveness indicators in 12 dimensions). Two rounds of Delphi identified four indicators that were omitted. The members of the final expert panel agreed on 113 indicators (43 risk management indicators in 4 dimensions and 70 clinical effectiveness indicators in 11 dimensions). In this study, indicators for assessing clinical governance in domains of risk management and clinical effectiveness were designed that can be used by policy-makers and other authorities for improving the quality of services and evaluating the performance of clinical governance. Those indicators can be used with slight modifications in other countries having healthcare systems similar to that of Iran. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  16. Clinical factors influencing mortality risk in hospital acquired sepsis.

    PubMed

    López-Mestanza, Cristina; Andaluz-Ojeda, David; Gómez-López, Juan Ramón; Bermejo Martín, Jesús F

    2017-09-04

    Identification of factors that confer an increased risk of mortality in hospital acquired sepsis (HAS) is necessary to help prevent, and improve the outcome of, this condition. To evaluate the clinical characteristics and factors associated with mortality in patients with HAS. Retrospective study of patients with HAS in a major Spanish Hospital from 2011 to 2015. Data from adults receiving any of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes associated with sepsis were collected. Those fulfilling the SEPSIS-2 definition with no evidence of infection during the first 48 hours following hospitalization were included (n=196). A multivariate analysis was employed to identify the risk factors of mortality. HAS patients were found to have many of the risk factors associated with cardiovascular disease (male sex, ageing, antecedent of cardiac disease, arterial hypertension, dyslipemia, smoking habit) and cancer. Vascular disease or chronic kidney disease were associated with 28 day mortality. Time from hospital admission to sepsis diagnosis, and the presence of organ failure were risk factors for 28-day and hospital mortality. Experiencing more than one episode of sepsis increased the risk of hospital mortality. "Sepsis Code" for the early identification of sepsis was protective against hospital mortality. We have identified a number of major factors associated to mortality in patients suffering from HAS. Implementation of surveillance programmes for the early identification and treatment of sepsis translate into a clear benefit. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  17. Time to Clinically Relevant Fracture Risk Scores in Postmenopausal Women.

    PubMed

    Gourlay, Margaret L; Overman, Robert A; Fine, Jason P; Crandall, Carolyn J; Robbins, John; Schousboe, John T; Ensrud, Kristine E; LeBlanc, Erin S; Gass, Margery L; Johnson, Karen C; Womack, Catherine R; LaCroix, Andrea Z

    2017-07-01

    Clinical practice guidelines recommend use of fracture risk scores for screening and pharmacologic treatment decisions. The timing of occurrence of treatment-level (according to 2014 National Osteoporosis Foundation guidelines) or screening-level (according to 2011 US Preventive Services Task Force guidelines) fracture risk scores has not been estimated in postmenopausal women. We conducted a retrospective competing risk analysis of new occurrence of treatment-level and screening-level fracture risk scores in postmenopausal women aged 50 years and older, prior to receipt of pharmacologic treatment and prior to first hip or clinical vertebral fracture. In 54,280 postmenopausal women aged 50 to 64 years without a bone mineral density test, the time for 10% to develop a treatment-level FRAX score could not be estimated accurately because of rare incidence of treatment-level scores. In 6096 women who had FRAX scores calculated with bone mineral density, the estimated unadjusted time to treatment-level FRAX ranged from 7.6 years (95% confidence interval [CI], 6.6-8.7) for those aged 65 to 69, to 5.1 years (95% CI, 3.5-7.5) for those aged 75 to 79 at baseline. Of 17,967 women aged 50 to 64 with a screening-level FRAX at baseline, 100 (0.6%) experienced a hip or clinical vertebral fracture by age 65 years. Postmenopausal women with sub-threshold fracture risk scores at baseline were unlikely to develop a treatment-level FRAX score between ages 50 and 64 years. After age 65, the increased incidence of treatment-level fracture risk scores, osteoporosis, and major osteoporotic fracture supports more frequent consideration of FRAX and bone mineral density testing. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Finasteride Reduces the Risk of Incident Clinical Benign Prostatic Hyperplasia

    PubMed Central

    Parsons, J. Kellogg; Schenk, Jeannette M.; Arnold, Kathryn B.; Messer, Karen; Till, Cathee; Thompson, Ian M.; Kristal, Alan R.

    2014-01-01

    Background Despite the high prevalence of clinical benign prostatic hyperplasia (BPH) among older men, there remains a notable absence of studies focused on BPH prevention. Objective To determine if finasteride prevents incident clinical BPH in healthy older men. Design, setting, and participants Data for this study are from the Prostate Cancer Prevention Trial. After excluding those with a history of BPH diagnosis or treatment, or an International Prostate Symptom Score (IPSS) ≥8 at study entry, 9253 men were available for analysis. Outcome measurements and statistical analysis The primary outcome was incident clinical BPH, defined as the initiation of medical treatment, surgery, or sustained, clinically significant urinary symptoms (IPSS >14). Finasteride efficacy was estimated using Cox proportional regression models to generate hazards ratios (HRs). Results and limitations Mean length of follow-up was 5.3 yr. The rate of clinical BPH was 19 per 1000 person-years in the placebo arm and 11 per 1000 person-years in the finasteride arm (p < 0.001). In a covariate-adjusted model, finasteride reduced the risk of incident clinical BPH by 40% (HR: 0.60; 95% confidence interval, 0.51–0.69; p < 0.001). The effect of finasteride on incident clinical BPH was attenuated in men with a body mass index ≥30 kg/m2 (pinteraction = 0.04) but otherwise did not differ significantly by physical activity, age, race, current diabetes, or current smoking. The post hoc nature of the analysis is a potential study limitation. Conclusions Finasteride substantially reduces the risk of incident clinical BPH in healthy older men. These results should be considered in formulating recommendations for the use of finasteride to prevent prostate diseases in asymptomatic older men. PMID:22459892

  19. The Fracture Risk Assessment Tool (FRAX®): applications in clinical practice.

    PubMed

    Watts, Nelson B

    2011-04-01

    Osteoporosis is a serious health concern affecting millions of Americans, with many patients going undiagnosed and untreated. Fractures due to osteoporosis and fracture-related complications are the most clinically relevant and costly consequences of this disorder. The Fracture Risk Assessment Tool (FRAX®), released by the World Health Organization (WHO) in February 2008, is a major achievement in helping determine which patients may be candidates for pharmacological therapy for osteoporosis. This Web-based algorithm, which has been incorporated into some dual x-ray absorptiometry (DXA) reporting software, calculates the 10-year probability of major osteoporotic fracture (clinical vertebral, hip, forearm, or humerus) and the 10-year probability of hip fracture in men and women based on easily obtained clinical risk factors and bone mineral density (BMD) of the femoral neck (optional). The National Osteoporosis Foundation updated its U.S. guidelines in February 2008 to incorporate FRAX and recommends that all postmenopausal women and men aged ≥50 years with a hip or vertebral fracture, a T-score ≤-2.5 at the femoral neck or spine (excluding secondary causes), or low bone mass (T-score between -1.0 and -2.5) and a 10-year probability of hip fracture ≥3% or of major osteoporosis-related fracture ≥20% (based on FRAX) should be considered candidates for drug therapy. Despite its demonstrated clinical utility, FRAX has limitations and should not be used in all situations. Acceptance and clinical use of FRAX may help identify men and women at increased risk for osteoporotic fracture, but implementing the tool into clinical practice may be a challenge for busy physicians.

  20. Prediction of Psychosis in Youth at High Clinical Risk

    PubMed Central

    Cannon, Tyrone D.; Cadenhead, Kristin; Cornblatt, Barbara; Woods, Scott W.; Addington, Jean; Walker, Elaine; Seidman, Larry J.; Perkins, Diana; Tsuang, Ming; McGlashan, Thomas; Heinssen, Robert

    2011-01-01

    Context Early detection and prospective evaluation of individuals who will develop schizophrenia or other psychotic disorders are critical to efforts to isolate mechanisms underlying psychosis onset and to the testing of preventive interventions, but existing risk prediction approaches have achieved only modest predictive accuracy. Objectives To determine the risk of conversion to psychosis and to evaluate a set of prediction algorithms maximizing positive predictive power in a clinical high-risk sample. Design, Setting, and Participants Longitudinal study with a 2½-year follow-up of 291 prospectively identified treatment-seeking patients meeting Structured Interview for Prodromal Syndromes criteria. The patients were recruited and underwent evaluation across 8 clinical research centers as part of the North American Prodrome Longitudinal Study. Main Outcome Measure Time to conversion to a fully psychotic form of mental illness. Results The risk of conversion to psychosis was 35%, with a decelerating rate of transition during the 2½-year follow-up. Five features assessed at baseline contributed uniquely to the prediction of psychosis: a genetic risk for schizophrenia with recent deterioration in functioning, higher levels of unusual thought content, higher levels of suspicion/paranoia, greater social impairment, and a history of substance abuse. Prediction algorithms combining 2 or 3 of these variables resulted in dramatic increases in positive predictive power (ie, 68%–80%) compared with the prodromal criteria alone. Conclusions These findings demonstrate that prospective ascertainment of individuals at risk for psychosis is feasible, with a level of predictive accuracy comparable to that in other areas of preventive medicine. They provide a benchmark for the rate and shape of the psychosis risk function against which standardized preventive intervention programs can be compared. PMID:18180426

  1. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population.

    PubMed

    Löwe, Bernd; Wahl, Inka; Rose, Matthias; Spitzer, Carsten; Glaesmer, Heide; Wingenfeld, Katja; Schneider, Antonius; Brähler, Elmar

    2010-04-01

    The 4-item Patient Health Questionnaire-4 (PHQ-4) is an ultra-brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). Given that PHQ-4, PHQ-2, and GAD-2 have not been validated in the general population, this study aimed to investigate their reliability and validity in a large general population sample and to generate normative data. A nationally representative face-to-face household survey was conducted in Germany in 2006. The survey questionnaire consisted of the PHQ-4, other self-report instruments, and demographic characteristics. Of the 5030 participants (response rate=72.9%), 53.6% were female and mean (SD) age was 48.4 (18.0) years. The sociodemographic characteristics of the study sample closely match those of the total populations in Germany as well as those in the United States. Confirmatory factor analyses showed very good fit indices for a two-factor solution (RMSEA .027; 90% CI .023-.032). All models tested were structurally invariant between different age and gender groups. Construct validity of the PHQ-4, PHQ-2, and GAD-2 was supported by intercorrelations with other self-report scales and with demographic risk factors for depression and anxiety. PHQ-2 and GAD-2 scores of 3 corresponded to percentile ranks of 93.4% and 95.2%, respectively, whereas PHQ-2 and GAD-2 scores of 5 corresponded to percentile ranks of 99.0% and 99.2%, respectively. A criterion standard diagnostic interview for depression and anxiety was not included. Results from this study support the reliability and validity of the PHQ-4, PHQ-2, and GAD-2 as ultra-brief measures of depression and anxiety in the general population. The normative data provided in this study can be used to compare a subject's scale score with those determined from a general population reference group. Copyright 2009 Elsevier B.V. All rights reserved.

  2. 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.

  3. [Risk factors and clinical features of ectopic pregnancy].

    PubMed

    Escobar-Padilla, Beatriz; Perez-López, Carlos A; Martínez-Puon, Horacio

    2017-01-01

    Ectopic pregnancy (EP) is the most frequent cause of maternal death in the first trimester of pregnancy. The objective was to establish the clinical features and risk factors associated with EP. Observational, retrospective, transversal and analytic case-control study. Two groups were included: the cases group (28 patients) and the control group (56 postpartum patients). Univariate and bivariate descriptive statistical analysis were carried out using the Pearson chi-square test, p < 0.05, with odds ratios (OR) and 95% confidence intervals (95% CI). Statistically significant values (OR) were: smoking: 18.33, history of EP: 11.96, IUD use: 11.9, abdominal surgery: 5.87, being multigravid: 3.80, and having two or more sexual partners: 2. The most common clinical symptom was pelvic pain with 57.1% (16), right ruptured EP 53.6%, tubal pregnancy 82.1% (23), unruptured EP 60.7% (17), hemoperitoneum 60.7% (17). Gestational age for EP was of 4-8 weeks (75%) and surgical treatment 96.4%. The frequency of EP found in our population was 1 in every 122 live births. Risk factors associated with ectopic pregnancy with statistically higher values were: smoking, being multigravid, having a clinical record of EP, IUD use before conception, abdominal surgery. The more frequent clinical characteristics were pelvic pain, right EP, tubal pregnancy, EP with no ruptures, hemoperitoneum < 750 ml, a gestational age between four and eight weeks.

  4. 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

  5. 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

  6. Sensory characteristics of youth at clinical high risk for psychosis.

    PubMed

    Parham, L Diane; Roush, Sean; Downing, Donna T; Michael, Paul G; McFarlane, William R

    2017-08-25

    To identify and compare the sensory characteristics of young people at clinical high risk (CHR) for psychosis to those of peers at clinical low risk (CLR), and to national normative data. CHR and CLR participants were recruited from 6 US regions. A descriptive cohort design was used to analyse baseline data collected as part of the Early Detection and Intervention for the Prevention of Psychosis Program (EDIPPP). Raw scores on the Adolescent/Adult Sensory Profile (AASP) were analysed for 205 young people with CHR and 87 with CLR in 2 age groups: 12 to 17 years (N = 203) and 18 to 25 years (N = 89). ANOVA procedures were used to determine whether differences in AASP scores existed across CLR, CHR, and normative groups by age group. CHR participants differed significantly from the normative group for all 4 AASP quadrant scores (Low Registration, Sensory Seeking, Sensory Sensitivity and Sensory Avoiding) in both age groups. CLR participants were similar to norms, except for Sensory Seeking scores that were significantly lower than norms in both age ranges. Young people with CHR demonstrate active avoidance, heightened sensitivity, reduced seeking, and reduced registration of sensations in everyday life compared to typical peers. This pattern of differences may be a valuable marker for identifying individuals who are at high risk for developing a psychotic illness, and may also inform interventions designed to prevent or minimize the illness process and accompanying dysfunction. © 2017 John Wiley & Sons Australia, Ltd.

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

    PubMed

    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.

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

    PubMed Central

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

    2014-01-01

    Smell identification deficits exist in schizophrenia, and may be associated with its negative symptoms. Less is known about smell identification and its clinical correlates in individuals at clinical high risk (CHR) for schizophrenia and related psychotic disorders. We examined smell identification, symptoms and IQ in 71 clinical high-risk (CHR) subjects and 36 healthy controls. Smell identification was assessed using both the 40-item University of Pennsylvania Smell Identification Test (UPSIT; Doty et al., 1984) and its extracted 12-item Brief Smell Identification Test (Goudsmit et al., 2003). Smell identification did not significantly differ between CHR subjects and controls. Among CHR subjects, smell identification did not predict schizophrenia (N = 19; 27%) within 2 years, nor was it associated with negative or positive symptoms. This is the third prospective cohort study to examine smell identification in CHR subjects, and overall, findings are inconclusive, similar to what is found for other disorders in adolescents, such as autism spectrum, attention deficit and anxiety disorders. Smell identification deficit may not have clear utility as a marker of emergent schizophrenia and related psychotic disorders. PMID:25066961

  9. 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

  10. 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

  11. 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

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

    PubMed

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

    2015-01-01

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

  13. 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

  14. Clinical Risk Factors for Primary Graft Dysfunction after Lung Transplantation

    PubMed Central

    Lee, James C.; Kawut, Steven M.; Shah, Rupal J.; Localio, A. Russell; Bellamy, Scarlett L.; Lederer, David J.; Cantu, Edward; Kohl, Benjamin A.; Lama, Vibha N.; Bhorade, Sangeeta M.; Crespo, Maria; Demissie, Ejigayehu; Sonett, Joshua; Wille, Keith; Orens, Jonathan; Shah, Ashish S.; Weinacker, Ann; Arcasoy, Selim; Shah, Pali D.; Wilkes, David S.; Ware, Lorraine B.; Palmer, Scott M.; Christie, Jason D.

    2013-01-01

    Rationale: Primary graft dysfunction (PGD) is the main cause of early morbidity and mortality after lung transplantation. Previous studies have yielded conflicting results for PGD risk factors. Objectives: We sought to identify donor, recipient, and perioperative risk factors for PGD. Methods: We performed a 10-center prospective cohort study enrolled between March 2002 and December 2010 (the Lung Transplant Outcomes Group). The primary outcome was International Society for Heart and Lung Transplantation grade 3 PGD at 48 or 72 hours post-transplant. The association of potential risk factors with PGD was analyzed using multivariable conditional logistic regression. Measurements and Main Results: A total of 1,255 patients from 10 centers were enrolled; 211 subjects (16.8%) developed grade 3 PGD. In multivariable models, independent risk factors for PGD were any history of donor smoking (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2–2.6; P = 0.002); FiO2 during allograft reperfusion (OR, 1.1 per 10% increase in FiO2; 95% CI, 1.0–1.2; P = 0.01); single lung transplant (OR, 2; 95% CI, 1.2–3.3; P = 0.008); use of cardiopulmonary bypass (OR, 3.4; 95% CI, 2.2–5.3; P < 0.001); overweight (OR, 1.8; 95% CI, 1.2–2.7; P = 0.01) and obese (OR, 2.3; 95% CI, 1.3–3.9; P = 0.004) recipient body mass index; preoperative sarcoidosis (OR, 2.5; 95% CI, 1.1–5.6; P = 0.03) or pulmonary arterial hypertension (OR, 3.5; 95% CI, 1.6–7.7; P = 0.002); and mean pulmonary artery pressure (OR, 1.3 per 10 mm Hg increase; 95% CI, 1.1–1.5; P < 0.001). PGD was significantly associated with 90-day (relative risk, 4.8; absolute risk increase, 18%; P < 0.001) and 1-year (relative risk, 3; absolute risk increase, 23%; P < 0.001) mortality. Conclusions: We identified grade 3 PGD risk factors, several of which are potentially modifiable and should be prioritized for future research aimed at preventative strategies. Clinical trial registered with www.clinicaltrials.gov (NCT

  15. Cholangiocarcinoma in primary sclerosing cholangitis: risk factors and clinical presentation.

    PubMed

    Boberg, K M; Bergquist, A; Mitchell, S; Pares, A; Rosina, F; Broomé, U; Chapman, R; Fausa, O; Egeland, T; Rocca, G; Schrumpf, E

    2002-10-01

    Primary sclerosing cholangitis (PSC) confers a high risk of cholangiocarcinoma (CC) development. Since patients at risk of CC may be selected for early liver transplantation, it is a challenge to identify any predisposing factors. We compared the presentation and natural history of a large number of PSC patients with and without later CC development to identify features associated with risk of CC. Clinical and laboratory data from presentation and follow-up were collected from 394 PSC patients from five European countries. The cohort included 48 (12.2%) patients with CC. CC was diagnosed within the first year after diagnosis of PSC in 24 (50%) cases and in 13 (27%) patients at intended liver transplantation. Jaundice, pruritus, abdominal pain and fatigue were significantly more frequent at diagnosis of PSC in the group that developed CC, but not after exclusion of cases diagnosed within the first year. Inflammatory bowel disease was diagnosed at least 1 year before PSC more often among patients with CC development than among those without (90% and 65%, respectively: P = 0.001). The duration of inflammatory bowel disease before diagnosis of PSC was significantly longer in patients who developed CC than in the remaining group (17.4 years and 9.0 years, respectively: P=0.009 in multivariate analysis). A high proportion of CC cases is diagnosed within the first year after diagnosis of PSC. A long history of inflammatory bowel disease is a risk factor for CC development.

  16. 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

  17. 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. Copyright © 2013 Elsevier Inc. All rights reserved.

  18. Heading off boundary problems: clinical supervision as risk management.

    PubMed

    Walker, R; Clark, J J

    1999-11-01

    The effective management of risk in clinical practice includes steps to limit harm to clients resulting from ethical violations or professional misconduct. Boundary problems constitute some of the most damaging ethical violations. The authors propose an active use of clinical supervision to anticipate and head off possible ethical violations by intervening when signs of boundary problems appear. The authors encourage a facilitative, Socratic method, rather than directive approaches, to help supervisees maximize their learning about ethical complexities. Building on the idea of a slippery slope, in which seemingly insignificant acts can lead to unethical patterns of behavior, the authors discuss ten cues to potential boundary problems, including strong feelings about a client; extended sessions with clients; gift giving between clinician and client; loans, barter, and sale of goods; clinician self-disclosures; and touching and sex. The authors outline supervisory interventions to be made when the cues are detected.

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

    PubMed

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

    2014-12-15

    Smell identification deficits exist in schizophrenia, and may be associated with its negative symptoms. Less is known about smell identification and its clinical correlates in individuals at clinical high risk (CHR) for schizophrenia and related psychotic disorders. We examined smell identification, symptoms and IQ in 71 clinical high-risk (CHR) subjects and 36 healthy controls. Smell identification was assessed using both the 40-item University of Pennsylvania Smell Identification Test (UPSIT; Doty, R.L., Shaman, P., Kimmelman, C.P., Dann, M.S., 1984. University of Pennsylvania Smell Identification Test: a rapid quantitative olfactory function test for the clinic. Laryngoscope 94, 176-178) and its extracted 12-item Brief Smell Identification Test (Goudsmit, N., Coleman, E., Seckinger, R.A., Wolitzky, R., Stanford, A.D., Corcoran, C., Goetz, R.R., Malaspina, D., 2003. A brief smell identification test discriminates between deficit and non-deficit schizophrenia. Psychiatry Research 120, 155-164). Smell identification did not significantly differ between CHR subjects and controls. Among CHR subjects, smell identification did not predict schizophrenia (N=19; 27%) within 2 years, nor was it associated with negative or positive symptoms. This is the third prospective cohort study to examine smell identification in CHR subjects, and overall, findings are inconclusive, similar to what is found for other disorders in adolescents, such as autism spectrum, attention deficit and anxiety disorders. Smell identification deficit may not have clear utility as a marker of emergent schizophrenia and related psychotic disorders. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. Tricuspid Regurgitation following Lead Extraction: Risk Factors and Clinical Course.

    PubMed

    Givon, Amir; Vedernikova, Natalia; Luria, David; Vatury, Ori; Kuperstein, Rafael; Feinberg, Micha S; Eldar, Michael; Glikson, Michael; Nof, Eyal

    2016-01-01

    Transvenous lead extraction can lead to tricuspid valve damage. To assess the incidence, risk factors and clinical outcome of tricuspid regurgitation (TR) following lead extraction. We prospectively collected data on patients who underwent lead extraction at the Sheba Medical Center prior to laser use (i.e., before 2012). Echocardiography results before and following the procedure were used to confirm TR worsening, defined as an echocardiographic increase of at least one TR grade. Various clinical and echocardiographic parameters were analyzed as risk factors for TR. Clinical and echocardiographic follow-up was conducted to assess the clinical significance outcome of extraction-induced TR. Of 152 patients who underwent lead extraction without laser before 2012, 86 (56%) (192 electrodes) had echocardiography results before and within one week following the procedure. New or worsening TR was discovered in 13 patients (15%). Use of mechanical tools and younger age at extraction were found on multivariate analysis to be factors for TR development (P = 0.04 and P = 0.03 respectively). Average follow-up was 22.25 ± 21.34 months (range 8-93). There were no significant differences in the incidence of right-sided heart failure (50% vs. 23%, P = 0.192) or hospitalizations due to heart failure exacerbations (37.5% vs. 11%, P = 0.110). No patient required tricuspid valve repair or replacement. Death rates were similar in the TR and non-TR groups (20% vs. 33%). TR following lead extraction is not uncommon but does not seem to affect survival or outcomes such as need for valve surgery. Its long-term effects remain to be determined.

  1. Systematic implementation of clinical risk management in a large university hospital: the impact of risk managers.

    PubMed

    Sendlhofer, Gerald; Brunner, Gernot; Tax, Christa; Falzberger, Gebhard; Smolle, Josef; Leitgeb, Karina; Kober, Brigitte; Kamolz, Lars Peter

    2015-01-01

    For health care systems in recent years, patient safety has increasingly become a priority issue. National and international strategies have been considered to attempt to overcome the most prominent hazards while patients are receiving health care. Thereby, clinical risk management (CRM) plays a dominant role in enabling the identification, analysis, and management of potential risks. CRM implementation into routine procedures within complex hospital organizations is challenging, as in the past, organizational change strategies using a top-down approach have often failed. Therefore, one of our main objectives was to educate a certain number of risk managers in facilitating CRM using a bottom-up approach. To achieve our primary purpose, five project strands were developed, and consequently followed, introducing CRM: corporate governance, risk management (RM) training, CRM process, information, and involvement. The core part of the CRM process involved the education of risk managers within each organizational unit. To account for the size of the existing organization, we assumed that a minimum of 1 % of the workforce had to be trained in RM to disseminate the continuous improvement of quality and safety. Following a roll-out plan, CRM was introduced in each unit and potential risks were identified. Alongside the changes in the corporate governance, a hospital-wide CRM process was introduced resulting in 158 trained risk managers correlating to 2.0 % of the total workforce. Currently, risk managers are present in every unit and have identified 360 operational risks. Among those, 176 risks were scored as strategic and clustered together into top risks. Effective meeting structures and opportunities to share information and knowledge were introduced. Thus far, 31 units have been externally audited in CRM. The CRM approach is unique with respect to its dimension; members of all health care professions were trained to be able to identify potential risks. A network of risk

  2. Adrenal incidentalomas: risk of adrenocortical carcinoma and clinical outcomes.

    PubMed

    O'Neill, Christine J; Spence, Andrew; Logan, Barney; Suliburk, James W; Soon, Patsy S; Learoyd, Diana L; Sidhu, Stan B; Sywak, Mark S

    2010-10-01

    The number of incidentally discovered adrenal lesions is increasing due to the widespread use of abdominal imaging. Although most incidentalomas are benign, larger suspicious lesions will require adrenalectomy. The aim of this study is to determine the risk of malignancy in patients undergoing surgery for adrenal incidentaloma; and to compare clinical outcomes in those with adrenocortical carcinoma (ACC) based on the mode of presentation. A retrospective study of consecutive patients who underwent adrenalectomy between 1995 and 2008 was performed. Data were retrieved from a prospectively maintained adrenal tumor database. Those with adrenal incidentaloma were selected and histopathology reviewed. All patients with ACC (presenting with symptoms or incidentally) during the same time period were identified and clinical outcomes compared. Adrenalectomy was performed in 274 patients of whom 73 (27%) were characterized pre-operatively as incidentaloma. Benign, non-functioning adrenocortical adenoma was the most common histopathological finding (46 patients, 63%). There was a trend (P = 0.08) towards increased survival amongst the seven patients with ACC presenting incidentally compared to the nine patients with symptomatic ACC. Adrenal incidentalomas have a small but important risk of malignancy. ACC presenting as incidentaloma appear to have a more favorable prognosis than symptomatic or functioning ACC. J. Surg. Oncol. 2010;102:450-453. © 2010 Wiley-Liss, Inc.

  3. 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

    2016-08-08

    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.

  4. 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."

  5. Population-Attributable Risk Proportion of Clinical Risk Factors for Breast Cancer.

    PubMed

    Engmann, Natalie J; Golmakani, Marzieh K; Miglioretti, Diana L; Sprague, Brian L; Kerlikowske, Karla

    2017-09-01

    Many established breast cancer risk factors are used in clinical risk prediction models, although the proportion of breast cancers explained by these factors is unknown. To determine the population-attributable risk proportion (PARP) for breast cancer associated with clinical breast cancer risk factors among premenopausal and postmenopausal women. Case-control study with 1:10 matching on age, year of risk factor assessment, and Breast Cancer Surveillance Consortium (BCSC) registry. Risk factor data were collected prospectively from January 1, 1996, through October 31, 2012, from BCSC community-based breast imaging facilities. A total of 18 437 women with invasive breast cancer or ductal carcinoma in situ were enrolled as cases and matched to 184 309 women without breast cancer, with a total of 58 146 premenopausal and 144 600 postmenopausal women enrolled in the study. Breast Imaging Reporting and Data System (BI-RADS) breast density (heterogeneously or extremely dense vs scattered fibroglandular densities), first-degree family history of breast cancer, body mass index (>25 vs 18.5-25), history of benign breast biopsy, and nulliparity or age at first birth (≥30 years vs <30 years). Population-attributable risk proportion of breast cancer. Of the 18 437 women with breast cancer, the mean (SD) age was 46.3 (3.7) years among premenopausal women and 61.7 (7.2) years among the postmenopausal women. Overall, 4747 (89.8%) premenopausal and 12 502 (95.1%) postmenopausal women with breast cancer had at least 1 breast cancer risk factor. The combined PARP of all risk factors was 52.7% (95% CI, 49.1%-56.3%) among premenopausal women and 54.7% (95% CI, 46.5%-54.7%) among postmenopausal women. Breast density was the most prevalent risk factor for both premenopausal and postmenopausal women and had the largest effect on the PARP; 39.3% (95% CI, 36.6%-42.0%) of premenopausal and 26.2% (95% CI, 24.4%-28.0%) of postmenopausal breast cancers could potentially be

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

    PubMed

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

    2016-01-01

    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. 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. 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. No failure risk rate per development phase is available for ATMPs. The discontinuation rate may prove helpful when assessing the

  7. Heterogeneity of Psychosis Risk Within Individuals at Clinical High Risk: A Meta-analytical Stratification.

    PubMed

    Fusar-Poli, Paolo; Cappucciati, Marco; Borgwardt, Stefan; Woods, Scott W; Addington, Jean; Nelson, Barnaby; Nieman, Dorien H; Stahl, Daniel R; Rutigliano, Grazia; Riecher-Rössler, Anita; Simon, Andor E; Mizuno, Masafumi; Lee, Tae Young; Kwon, Jun Soo; Lam, May M L; Perez, Jesus; Keri, Szabolcs; Amminger, Paul; Metzler, Sibylle; Kawohl, Wolfram; Rössler, Wulf; Lee, Jimmy; Labad, Javier; Ziermans, Tim; An, Suk Kyoon; Liu, Chen-Chung; Woodberry, Kristen A; Braham, Amel; Corcoran, Cheryl; McGorry, Patrick; Yung, Alison R; McGuire, Philip K

    2016-02-01

    Individuals can be classified as being at clinical high risk (CHR) for psychosis if they meet at least one of the ultra-high-risk (UHR) inclusion criteria (brief limited intermittent psychotic symptoms [BLIPS] and/or attenuated psychotic symptoms [APS] and/or genetic risk and deterioration syndrome [GRD]) and/or basic symptoms [BS]. The meta-analytical risk of psychosis of these different subgroups is still unknown. To compare the risk of psychosis in CHR individuals who met at least one of the major inclusion criteria and in individuals not at CHR for psychosis (CHR-). Electronic databases (Web of Science, MEDLINE, Scopus) were searched until June 18, 2015, along with investigation of citations of previous publications and a manual search of the reference lists of retrieved articles. We included original follow-up studies of CHR individuals who reported the risk of psychosis classified according to the presence of any BLIPS, APS and GRD, APS alone, GRD alone, BS, and CHR-. Independent extraction by multiple observers and random-effects meta-analysis of proportions. Moderators were tested with meta-regression analyses (Bonferroni corrected). Heterogeneity was assessed with the I2 index. Sensitivity analyses tested robustness of results. Publication biases were assessed with funnel plots and the Egger test. The proportion of each subgroup with any psychotic disorder at 6, 12, 24, 36, and 48 or more months of follow-up. Thirty-three independent studies comprising up to 4227 individuals were included. The meta-analytical proportion of individuals meeting each UHR subgroup at intake was: 0.85 APS (95%CI, 0.79-0.90), 0.1 BLIPS (95%CI, 0.06-0.14), and 0.05 GRD (95%CI, 0.03-0.07). There were no significant differences in psychosis risk at any time point between the APS and GRD and the APS-alone subgroups. There was a higher risk of psychosis in the any BLIPS greater than APS greater than GRD-alone subgroups at 24, 36, and 48 or more months of follow-up. There was no

  8. [From the Mailing List SIN: professional risks for the nephrologists: clinical risk and risk management].

    PubMed

    Galato, R; Fraticelli, M; D'Amico, M; Limido, A; Bevilacqua, L

    2005-01-01

    An extensive debate on bacteraemias due to aquatic bacteria has recently developed in the Mailing List SIN. This topic was analyzed in two previous issues where the epidemics observed in two Dialysis Centers have been presented and discussed. The two experiences had in common the difficulty in identifying the source of contamination in industrial products commercialized as ''sterile''. In one case, the source of the epidemic could not be identified, in the other one it was discovered only incidentally thanks to a notice of the supplier company of the contaminated material. This underlines the importance of defining specific operating protocols in case of hospital epidemics and stresses the issues related to the professional risk and the potential legal implications.

  9. 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

  10. Risk management in clinical practice. Part 9. Dental implants.

    PubMed

    Palmer, R M

    2010-11-27

    Patients have high expectations of dental implants in terms of appearance, function and longevity. It is essential that these expectations are realistically managed and that treatment of the highest standard is provided. This involves very careful evaluation, including clinical and radiographic, and presentation of the pros and cons of treatment alternatives. Provision of a successful implant restoration requires many skills including a surgical procedure to place the implant in the best possible position and prosthodontic techniques to provide an aesthetic restoration in occlusal harmony with the rest of the dentition. Recognition of risk factors and long-term maintenance requirements are equally important. Clinicians involved in these treatments must obtain adequate training and develop skills through treatment of straightforward cases using well established protocols before embarking on more demanding cases.

  11. Cyberbullying in those at clinical high risk for psychosis.

    PubMed

    Magaud, Emilie; Nyman, Karissa; Addington, Jean

    2013-11-01

    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. Fifty young people at CHR for psychosis were administered the Childhood Trauma Questionnaire with added questions about cyberbullying. Cyberbullying was reported in 38% of the sample. Those who experienced cyberbullying also reported experiencing previous trauma. 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. © 2013 Wiley Publishing Asia Pty Ltd.

  12. Risk of osteoporosis in elderly individuals attending a dental clinic.

    PubMed

    Ohtsuki, Hideto; Kawakami, Masayoshi; Kawakami, Tetsuji; Takahashi, Kazuya; Kirita, Tadaaki; Komasa, Yutaka

    2017-04-01

    Osteoporosis has become a critical public health problem with the rapidly aging population in Japan. It is necessary for dentists to know their patients' status because it influences dental treatment. The purpose of this study was to predict the risk of osteoporosis in elderly patients visiting a dental clinic by assessing mandibular cortical morphology on panoramic radiographs. Three-hundred and thirty patients were divided into three classes based on the morphology of their mandibular cortex on panoramic radiographs. Mandibular cortical bone width at the mental foramen was also measured. Bone mineral density (BMD) was determined at the calcaneus using a quantitative ultrasound device. The mandibular cortical width decreased significantly from Class 1 (normal cortex), to Class 2 (moderately eroded cortex) and to Class 3 (severely eroded cortex). BMD was negatively correlated with age in both female and male patients. Most (108/186) female patients had a class 3 cortex with a low BMD. Among women, mandibular cortical width was significantly correlated with BMD. Thirty-three percent of the female had received a previous diagnosis of osteoporosis. In contrast, only 13.9% (20/144) of the male had a Class 3 cortex. In men, mandibular cortical width did not significantly correlate with BMD. Only a few of the men had received a previous diagnosis of osteoporosis. The number of remaining teeth did not correlate with low BMD in either sex. Our findings reveal that most elderly female patients visiting the dental clinic had a high risk of osteoporosis and a low BMD. © 2016 FDI World Dental Federation.

  13. Risk Factors, Clinical Presentation, and Outcomes for Abdominal Wall Endometriosis.

    PubMed

    Khan, Zaraq; Zanfagnin, Valentina; El-Nashar, Sherif A; Famuyide, Abimbola O; Daftary, Gaurang S; Hopkins, Matthew R

    To evaluate the risk factors, presentation, and outcomes in cases of abdominal wall endometriosis. A case-control study (Canadian Task Force classification II-2). An academic medical center. A total of 102 (34 cases and 68 controls) were included. Surgical resection of abdominal wall endometriosis. Cases underwent surgical excision for abdominal wall endometriosis at Mayo Clinic from January 1, 2000, through December 31, 2013. For each case, 2 controls were randomly selected from a list of women who had surgery in the same year with minimal (American Society for Reproductive Medicine stage I-II) endometriosis. A chart review was completed for variables of interest. Regression models were used to identify independent risk factors associated with abdominal wall endometriosis. In 14 years, 2539 women had surgery for endometriosis at Mayo Clinic. Of these, only 34 (1.34%) had abdominal wall endometriosis. The mean age was 35.2 ± 5.9 years, and the median parity was 2 (range, 0-5). Clinical examination diagnosed abdominal wall endometriosis in 41% of cases, with the cesarean delivery scar being the most common site (59%). There was a strong correlation between the size of the lesion on clinical examination compared with the size of the pathology specimen (r(2) = 0.74, p < .001). When compared with controls, cases had significantly higher parity and body mass index, more cyclic localized abdominal pain, less dysmenorrhea, longer duration from the start of symptoms to surgery, and more gynecologic surgeries for symptoms without cure. In the final multivariable model, cyclic localized abdominal pain, absence of dysmenorrhea, and previous laparotomy were independently associated with abdominal wall endometriosis with adjusted odds ratios of 10.6 (95% CI 1.85-104.4, p < .001), 12.4 (95% CI 1.64-147.1, p < .001), and 70.1 (95% CI 14.8-597.7, p < .001), respectively, with an area under the curve for the receiver operating characteristic of 0.94 (95% CI, 0

  14. 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

  15. Corticosteroids in chronic obstructive pulmonary disease. Clinical benefits and risks.

    PubMed

    McEvoy, C E; Niewoehner, D E

    2000-12-01

    The use of systemic and inhaled corticosteroids for COPD has increased appreciably over the past 20 years. Clearer indications for corticosteroid therapy in COPD are beginning to emerge as the results from large clinical trials become available. Systemic corticosteroids are only modestly effective for acute COPD exacerbations, increase the risk for hyperglycemia, and should be given for no more than 2 weeks. The efficacy of long-term systemic corticosteroid therapy has not been adequately evaluated in this patient population. If longer term use of systemic steroids in COPD should be found to be useful, this conclusion would have to be weighed against the risk for serious adverse effects. High doses of inhaled corticosteroids cause a small sustained increase of the FEV1 in patients with mild and moderately severe COPD, but they do not slow the rate of FEV1 decline. Based on analyses of secondary outcome, inhaled corticosteroids may improve the respiratory symptoms and decrease the number and severity of COPD exacerbations in patients with more advanced disease. Low doses of inhaled corticosteroids appear to be safe, but there is growing awareness that higher doses may not be so benign.

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

    PubMed

    Briner, Matthias; Kessler, Oliver; Pfeiffer, Yvonne; Wehner, Theo; Manser, Tanja

    2010-12-13

    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. 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. 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. 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.

  17. Practical, transparent prospective risk analysis for the clinical laboratory.

    PubMed

    Janssens, Pim Mw

    2014-11-01

    Prospective risk analysis (PRA) is an essential element in quality assurance for clinical laboratories. Practical approaches to conducting PRA in laboratories, however, are scarce. On the basis of the classical Failure Mode and Effect Analysis method, an approach to PRA was developed for application to key laboratory processes. First, the separate, major steps of the process under investigation are identified. Scores are then given for the Probability (P) and Consequence (C) of predefined types of failures and the chances of Detecting (D) these failures. Based on the P and C scores (on a 10-point scale), an overall Risk score (R) is calculated. The scores for each process were recorded in a matrix table. Based on predetermined criteria for R and D, it was determined whether a more detailed analysis was required for potential failures and, ultimately, where risk-reducing measures were necessary, if any. As an illustration, this paper presents the results of the application of PRA to our pre-analytical and analytical activities. The highest R scores were obtained in the stat processes, the most common failure type in the collective process steps was 'delayed processing or analysis', the failure type with the highest mean R score was 'inappropriate analysis' and the failure type most frequently rated as suboptimal was 'identification error'. The PRA designed is a useful semi-objective tool to identify process steps with potential failures rated as risky. Its systematic design and convenient output in matrix tables makes it easy to perform, practical and transparent. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  18. Resilience in individuals at clinical high risk for psychosis.

    PubMed

    Marulanda, Susana; Addington, Jean

    2016-06-01

    It has been suggested that resilience may be a protective factor with respect to mental illness. This may be an important factor for those who are vulnerable to psychiatric illness. Thus, the aims of this paper were to compare levels of resilience between individuals at clinical high risk (CHR) for psychosis and healthy controls, and to examine associations between resilience and clinical measures, functioning and trauma of CHR participants. Eighty participants, 40 CHR and 40 University of Calgary undergraduate students, completed two resilience questionnaires: the Connor-Davidson Resilience Scale and the Child and Youth Resilience Measure. A t-test revealed a significant difference between the groups on levels of resilience (t = 4.34, P < 0.01), demonstrating that CHR participants have lower levels of resilience than healthy controls. In terms of the associations between resilience and measures of mental health of CHR participants, it was found that higher levels of resilience were related to lower negative symptoms, depression and anxiety. Furthermore, resilient CHR participants showed higher levels of role functioning and generally reported higher positive schemas of self and others, as well as lower stress to reported life events. No associations were found between resilience and attenuated psychotic symptoms, social functioning, IQ and trauma. The results of the current study suggest that resilience may be beneficial to other mental issues present in CHR individuals but this may not be the case for attenuated psychotic symptoms. © 2014 Wiley Publishing Asia Pty Ltd.

  19. Resilience in Individuals at Clinical High Risk for Psychosis

    PubMed Central

    Marulanda, Susana; Addington, Jean

    2015-01-01

    Background It has been suggested that resilience may be a protective factor with respect to mental illness. This may be an important factor for those who are vulnerable to psychiatric illness. Thus, the aims of this paper were to compare levels of resilience between individuals at clinical high risk (CHR) for psychosis and healthy controls, and to examine associations between resilience and clinical measures, functioning, and trauma of CHR participants. Method Eighty participants, 40 CHR and 40 University of Calgary undergraduate students, completed two resilience questionnaires: the Connor-Davidson Resilience Scale and the Child and Youth Resilience Measure. Results A t-test revealed a significant difference between the groups on levels of resilience (t=4.34, p <0.01), demonstrating that CHR participants have lower levels of resilience than healthy controls. In terms of the associations between resilience and measures of mental health of CHR participants, it was found that higher levels of resilience were related to lower negative symptoms, depression, and anxiety. Furthermore, resilient CHR participants showed higher levels of role functioning and generally reported higher positive schemas of self and others, as well as lower stress to reported life events. No associations were found between resilience and attenuated psychotic symptoms, social functioning, IQ, and trauma. Conclusions The results of the current study suggest that resilience may be beneficial to other mental issues present in CHR individuals but this may not be the case for attenuated psychotic symptoms. PMID:25234104

  20. Fuzzy risk stratification and risk assessment model for clinical monitoring in the ICU.

    PubMed

    Dervishi, Albion

    2017-08-01

    The decisions that clinicians make in intensive care units (ICUs) based on monitored parameters reflecting physiological deterioration are of major medical and biomedical engineering interest. These parameters have been investigated and assessed for their usefulness in risk assessment. Totally, 127 ICU adult patients were studied. They were selected from a MIMIC II Waveform Database Matched Subset and had continuous monitoring of heart rate, invasive blood pressure, and oxygen saturation. The monitored data were dimension reduced using deep learning autoencoders and then used to train a support vector machine model (SVM). A combination of methods including fuzzy c-means clustering (FCM), and a random forest (RF) was used to determine the risk levels. When classifying patients into stable or deteriorating groups the main performance parameter was the receiver operating characteristics (ROC). The area under the ROC (AUROC) was 93.2 (95% CI (92.9-93.4)) with sensitivity and specificity values of 0.80 and 0.89, respectively. The suggested fuzzy risk levels using the combined method of the FCM clustering and RF achieved an accuracy of 1 (0.9999, 1), with both sensitivity and specificity values equal to 1. The potential for using models in risk assessment to estimate a patient's physiological status, stable or deteriorating, within 4 h has been demonstrated. The study was based on retrospective analysis and further studies are needed to evaluate the impact on clinical outcomes using this model. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. 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

    2016-02-29

    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.

  2. 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

  3. 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

  4. Clinical psychopathology in youth at familial high risk for psychosis.

    PubMed

    Shah, Jai L; Tandon, Neeraj; Montrose, Debra M; Mermon, Diana; Eack, Shaun M; Miewald, Jean; Keshavan, Matcheri S

    2017-09-07

    While the course of psychopathology has been explored from an index mental health diagnosis onwards, there are few detailed, prospective studies of the occurrence of clinical psychopathology in youth with familial risk for severe mental illnesses such as psychosis. We sought to describe the appearance of Axis I psychopathology in a unique sample of adolescents with a family history of schizophrenia (FHR). One hundred and sixty two first- and second-degree relatives (mean age 15.7 ± 3.6; range 8-25) of probands with schizophrenia or schizoaffective disorder were assessed at baseline and annual intervals for up to 3 years, focusing on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis I psychopathology. Fourteen individuals (8.6%) developed a psychotic disorder. One hundred and five subjects (65%) met criteria for an Axis I disorder over the course of the study, the most common of which was a depressive episode (40 subjects; 25%). Of the 148 individuals who did not develop psychosis, 91 (61%) had one or more Axis I disorders compared with 10/14 converters who had a comorbid Axis I disorder (71%). Ordered by increasing age of onset, diagnoses included cognitive and externalizing disorders, anxiety disorders, affective disorders, substance use disorders and psychotic disorders. In addition to an elevated risk of psychosis, young FHR relatives manifest a broad range of non-psychotic Axis I psychopathology in childhood and adolescence. This breadth of diagnoses has implications for the structure and function of mental health services for young people. © 2017 John Wiley & Sons Australia, Ltd.

  5. Orthodontics and enamel demineralization: clinical study of risk factors.

    PubMed

    Benkaddour, Asmae; Bahije, Loubna; Bahoum, Asmae; Zaoui, Fatima

    2014-12-01

    The appearance of white spots on the vestibular surface of teeth fitted with brackets has been described as one of the potential iatrogenic effects of orthodontic treatment. These enamel demineralizations, more commonly known as "white spot lesions" (WSL), lead in some rare cases to the creation of true cavities, causing both esthetic and functional problems. The aim of our retrospective clinical study was to evaluate the incidence of the appearance of these WSL in a Moroccan orthodontic population and to determine possible associations with a number of risk factors. The study was based on intraoral photographs of a pool of 69 patients who underwent orthodontic treatment with or without extractions in the DFO unit of the Rabat CCDT (Center for dental consultation and treatment). Patients with prostheses or WSL before the beginning of the study were excluded. Digital start- and end-of-treatment photos for each patient were compared by a single operator looking for the appearance of WSL on the vestibular surfaces of the incisors, canines, premolars and first molars. WSL were classed according to three degrees of severity: slight, severe and cavitation. Data were processed using SPSS 13.0 software. The results of the study showed that the prevalence of WSL in the sample was 66.7%, with a highly significant predominance of localization in the premolar/molar segment and in patients with poor oral hygiene. Poor oral and dental hygiene was identified as the most important risk factor for the development of white spots during multibracket orthodontic treatment. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  6. Maximizing Retention with High Risk Participants in a Clinical Trial

    PubMed Central

    Kim, Romina; Hickman, Norval; Gali, Kathleen; Orozco, Nicholas; Prochaska, Judith J.

    2016-01-01

    Purpose To describe effective retention strategies in a clinical trial with a high risk, low income, and vulnerable patient population with serious mental illness. Design Follow-up assessments were conducted for a randomized clinical tobacco treatment trial at 3-, 6-, and 12-months post-baseline. Initial follow-up rates of <40% at 3-months led to implementation of proactive retention strategies including obtaining extensive contact information; building relationships with case managers and social workers; contacting jails and prisons; text messaging, e-mailing, and messaging via social networking sites; identifying appointments via electronic medical record; and field outreach to treatment facilities, residences, and parks. Setting Large urban public hospital Subjects Participants were current smokers recruited from 100% smoke-free locked psychiatry units. Measures Assessments covered demographics, substance use, and mental health functioning. Analysis Retention rates were plotted over time in relation to key retention strategies. Chi-square and t-tests were used to examine participant predictors of retention at each follow-up. At the 12-month follow-up, the retention strategies that most frequently led to assessment completion were identified. Results The sample (N=100) was 65% male; age M=39.5 years (SD=11.3); 44% non-Hispanic White; 46% on Medicaid and 34% uninsured; 79% unemployed; and 48% unstably housed. Proactive retention strategies dramatically increased follow-up rates, concluding at 3-months=82.65%, 6-months=89.69%, and 12-months=92.78%. Married and divorced/separated/widowed participants, those with higher income, and participants with alcohol or illicit drug problems had increased retention from 3 to 12-months follow-up. Conclusion Follow-up rates improved as proactive methods to contact participants were implemented. Dedicated research staff, multiple methods, community networking, and outreach within drug treatment settings improved retention. PMID

  7. Maximizing retention with high risk participants in a clinical trial.

    PubMed

    Kim, Romina; Hickman, Norval; Gali, Kathleen; Orozco, Nicholas; Prochaska, Judith J

    2014-01-01

    To describe effective retention strategies in a clinical trial with a high risk, low-income, and vulnerable patient population with serious mental illness. Follow-up assessments were conducted for a randomized clinical tobacco treatment trial at 3, 6, and 12 months postbaseline. Initial follow-up rates of <40% at 3 months led to implementation of proactive retention strategies including obtaining extensive contact information; building relationships with case managers and social workers; contacting jails and prisons; text messaging, e-mailing, and messaging via social networking sites; identifying appointments via electronic medical record; and field outreach to treatment facilities, residences, and parks. Large urban public hospital. Participants were current smokers recruited from 100% smoke-free locked psychiatry units. Assessments covered demographics, substance use, and mental health functioning. Retention rates were plotted over time in relation to key retention strategies. Chi-square and t-tests were used to examine participant predictors of retention at each follow-up. At the 12-month follow-up, the retention strategies that most frequently led to assessment completion were identified. The sample (N = 100) was 65% male; age x = 39.5 years (SD = 11.3); 44% non-Hispanic white; 46% on Medicaid and 34% uninsured; 79% unemployed; and 48% unstably housed. Proactive retention strategies dramatically increased follow-up rates, concluding at 3 months = 82.65%, 6 months = 89.69%, and 12 months = 92.78%. Married and divorced/separated/widowed participants, those with higher income, and participants with alcohol or illicit drug problems had increased retention from 3- to 12-month follow-up. Follow-up rates improved as proactive methods to contact participants were implemented. Dedicated research staff, multiple methods, community networking, and outreach within drug treatment settings improved retention.

  8. Peri-implantitis in a specialist clinic of periodontology. Clinical features and risk indicators.

    PubMed

    Carcuac, Olivier; Jansson, Leif

    2010-01-01

    Implant therapy has become a widely recognized treatment alternative for replacing missing teeth. Several long term follow-up studies have shown that the survival rate is high. However, complications may appear and risk indcators associated with early and late failures have been identified. The purpose of the present retrospective clinical study was to describe some clinical features of patients with clinical signs of peri-implantitis and to identify risk indicators of peri-implantitis in a population at a specialist clinic of Periodontology. In total,the material consisted of 377 implants in 111 patients with the diagnosis peri-implantitis. The mean age at the examination was found to be 56.3 years (range 22-83) for females and 64.1 years (range 27-85) for males. The mean number of remaining teeth was found to be 10.5 (S.D. 8.89) and the mean number of implants was 5.85 (S.D. 3.42). For a majority of the subjects, more than 50% of the remaining teeth had a marginal bone loss of more than 1/3 of the root length. Forty-sex percent of the patients visited regularly dental hygienists for supportive treatment. The percentage of implants with peri-implantitis was significantly increased for smokers compared to non-smokers (p = 0.04). In the group of non-smokers, 64% of the implants had the diagnosis peri-implantitis, while the corresponding relative frequency for smokers was 78%. A majority of the individuals had a Plaque index and Bleeding on probing index >50%. The median of the follow-up time after implant placement was 7.4 years and the observation period was not significantly correlated to the degree of bone loss around the implants. Among the subjects with a mean bone loss >6 mm at implants with peri-implantitis, more than 70% had a mean marginal bone loss > 1/3 of the root length of the remaining teeth. A positive and significant correlation was found between the degree of marginal bone loss in remaining teeth and the degree of bone loss around implants with peri

  9. Risk factors and clinical features of text message injuries.

    PubMed

    Sharan, Deepak; Ajeesh, P S

    2012-01-01

    Use of mobile phone and sending text message is a very common in today's life. While sending a text message the users need to use their thumb and other palm muscles extensively. The thumb most of the time adducted on the key pad of the mobile and use high force to type the letters. Studies in literature showed that text messaging has an adverse effect on musculoskeletal system of hand. But the extensive study on the type of disorders set in among the users who extensively use mobile phone for texting. This study aims at to evaluate risk factor and clinical feature of the MSD due to hand held devices. Twenty seven subjects participated in this study. Predefined protocols were used to evaluate type of MSD occurred among the subjects. The study revealed that development of tendinitis in extensor pollicis longus, myofascial pain syndrome (70.37%) of adductor pollicis, 1st interossei and extensor digitorum communis . Other associated problems diagnosed were thoracic outlet syndrome (51.85%), fibromyalgia syndrome (25.93%), hypothyroidism (7.41%), wrist tendinitis (14.81%) and De Quervain's syndrome (7.41%). It has been observed that the pathology were tendinitis of extensor pollicis longus, myofascial pain syndrome of thenar muscles and 1st interossei, extensor digitorum communis.

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

    PubMed

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

    2012-01-01

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

  11. Clinical characteristics and risk factors of ocular candidiasis.

    PubMed

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

    2012-06-01

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

  12. A biomechanical sorting of clinical risk factors affecting osteoporotic hip fracture.

    PubMed

    Luo, Y

    2016-02-01

    Osteoporotic fracture has been found associated with many clinical risk factors, and the associations have been explored dominantly by evidence-based and case-control approaches. The major challenges emerging from the studies are the large number of the risk factors, the difficulty in quantification, the incomplete list, and the interdependence of the risk factors. A biomechanical sorting of the risk factors may shed lights on resolving the above issues. Based on the definition of load-strength ratio (LSR), we first identified the four biomechanical variables determining fracture risk, i.e., the risk of fall, impact force, bone quality, and bone geometry. Then, we explored the links between the FRAX clinical risk factors and the biomechanical variables by looking for evidences in the literature. To accurately assess fracture risk, none of the four biomechanical variables can be ignored and their values must be subject-specific. A clinical risk factor contributes to osteoporotic fracture by affecting one or more of the biomechanical variables. A biomechanical variable represents the integral effect from all the clinical risk factors linked to the variable. The clinical risk factors in FRAX mostly stand for bone quality. The other three biomechanical variables are not adequately represented by the clinical risk factors. From the biomechanical viewpoint, most clinical risk factors are interdependent to each other as they affect the same biomechanical variable(s). As biomechanical variables must be expressed in numbers before their use in calculating LSR, the numerical value of a biomechanical variable can be used as a gauge of the linked clinical risk factors to measure their integral effect on fracture risk, which may be more efficient than to study each individual risk factor.

  13. 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

  14. Therapeutic risk management of clinical-legal dilemmas: should it be a core competency?

    PubMed

    Simon, Robert I; Shuman, Daniel W

    2009-01-01

    Therapeutic risk management of clinical-legal dilemmas achieves an optimal alignment between clinical competence and an understanding of legal concerns applicable to psychiatric practice. Understanding how psychiatry and law interact in frequently occurring clinical situations is essential for effective patient care. Successful management of clinical-legal dilemmas also avoids unnecessary, counterproductive defensive practices.

  15. Clinical Risk Factors Associated With Peripartum Maternal Bacteremia.

    PubMed

    Easter, Sarah Rae; Molina, Rose L; Venkatesh, Kartik K; Kaimal, Anjali; Tuomala, Ruth; Riley, Laura E

    2017-10-01

    To evaluate risk factors associated with maternal bacteremia in febrile peripartum women. We performed a case-control study of women with fevers occurring between 7 days before and up to 42 days after delivery of viable neonates at two academic hospitals. Women with positive blood cultures were matched with the next two febrile women meeting inclusion criteria with negative blood cultures in the microbiology data without other matching parameters. We compared maternal and neonatal characteristics and outcomes between women in the case group and those in the control group with univariate analysis. We then used logistic regression to examine the association between clinical characteristics and maternal bacteremia. After excluding blood cultures positive only for contaminants, we compared 115 women in the case group with 285 in the control group. Bacteremic women were more likely to experience their initial fever during labor (40.9% compared with 22.8%, P<.01) and more likely to have fever at or above 102°F (62.6% compared with 31.6%, P<.01). These associations persisted in the adjusted analysis: multiparity (adjusted odds ratio [OR] 1.75, 95% CI 1.07-2.87), initial fever during labor (adjusted OR 2.82, 95% CI 1.70-4.70), and fever at or above 102°F (adjusted OR 3.83, 95% CI 2.37-6.19). In an analysis restricted to neonates whose mothers had initial fevers before or in the immediate 24 hours after delivery, neonates born to women in the case group had higher rates of bacteremia compared with those born to women in the control group (9.0% compared with 1.3%, P<.01). Eight of the nine bacteremic neonates born to bacteremic mothers (89%) grew the same organism as his or her mother in blood culture. Maternal bacteremia is associated with multiparity, initial fever during labor, and fever at or above 102°F; however, 37.5% of cases of bacteremia occurred in women with maximum fevers below this threshold. Obstetricians should maintain a heightened suspicion for an

  16. 'Mechanical restraint-confounders, risk, alliance score': testing the clinical validity of a new risk assessment instrument.

    PubMed

    Deichmann Nielsen, Lea; Bech, Per; Hounsgaard, Lise; Alkier Gildberg, Frederik

    2017-08-01

    Unstructured risk assessment, as well as confounders (underlying reasons for the patient's risk behaviour and alliance), risk behaviour, and parameters of alliance, have been identified as factors that prolong the duration of mechanical restraint among forensic mental health inpatients. To clinically validate a new, structured short-term risk assessment instrument called the Mechanical Restraint-Confounders, Risk, Alliance Score (MR-CRAS), with the intended purpose of supporting the clinicians' observation and assessment of the patient's readiness to be released from mechanical restraint. The content and layout of MR-CRAS and its user manual were evaluated using face validation by forensic mental health clinicians, content validation by an expert panel, and pilot testing within two, closed forensic mental health inpatient units. The three sub-scales (Confounders, Risk, and a parameter of Alliance) showed excellent content validity. The clinical validations also showed that MR-CRAS was perceived and experienced as a comprehensible, relevant, comprehensive, and useable risk assessment instrument. MR-CRAS contains 18 clinically valid items, and the instrument can be used to support the clinical decision-making regarding the possibility of releasing the patient from mechanical restraint. The present three studies have clinically validated a short MR-CRAS scale that is currently being psychometrically tested in a larger study.

  17. 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.

  18. 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

  19. Medical errors and clinical risk management: state of the art.

    PubMed

    La Pietra, L; Calligaris, L; Molendini, L; Quattrin, R; Brusaferro, S

    2005-12-01

    Medical errors represent a serious public health problem and pose a threat to patient safety. All patients are potentially vulnerable, therefore medical errors are costly from a human, economic, and social viewpoint. The present report aims not only to provide an overview of the problem on the basis of the published literature, but also to stress the importance of adopting standard terminology and classifications, fundamental tools for researchers to obtain valid and reliable methods for error identification and reporting. In fact, agreement on standard definitions allows comparison of data in different contexts. Errors can be classified according to their outcome, the setting where they take place (inpatient, outpatient), the kind of procedure involved (medication, surgery, etc.) or the probability of occurring (high, low). Error categories are analysed taking into consideration their prevalence, avoidance and associated factors as well as the different strategies for detecting medical errors. Incident reporting and documentation of near-misses are described as useful sources of information, and Healthcare Failure Mode Effect Analysis (HFMEA) and Root Cause Analysis (RCA) are seen as powerful methods for process analysis. Furthermore, means to increase patient safety are considered in the broader context of clinical risk management. New approaches in the field of medical errors are aimed at minimizing the recurrence of avoidable patterns associated with higher error rate. A system approach and a blame-free environment, aimed at better organizational performances, lead to much better results than focusing on individuals. Furthermore, use of technology, information accessibility, communication, patient collaboration and multi-professional team-work are successful strategies to reach the goal of patient safety within healthcare organizations.

  20. 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. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. Can we risk recovery? A grounded theory of clinical psychologists' perceptions of risk and recovery-oriented mental health services.

    PubMed

    Tickle, Anna; Brown, Dora; Hayward, Mark

    2014-03-01

    This study sought to explore the views of clinical psychologists towards the concepts of 'risk' and 'recovery' and to set those views against the context of mental health services. An exploratory, social constructionist grounded theory methodology was adopted. Eleven clinical psychologists working in adult mental health services each participated in one individual semistructured interview. The clinical psychologists studied were aware of the emergence of recovery-oriented approaches, but felt unable to incorporate them in practice because of perceptions of being bound by both their own limitations and those of their circumstances, including issues of risk, thus giving rise to dilemmas in professional practice. Narrow definitions of risk as equated to danger dominated over broader conceptualizations of risk with positive consequences. The existing culture of mental health services was seen as emphasizing the need to avoid harmful consequences of taking risks, which in turn was seen to limit innovations in implementing recovery-oriented approaches. Participants' ability to work in a recovery-oriented manner seemed to be limited by the way in which services perceived and responded to risk. Participants did not discuss risks arising from stigma, social exclusion, racism, sexism, or iatrogenic effects of psychiatric treatment. Narrow conceptualizations of risk as related to harm and danger seen in this study contribute to a sense of needing to be risk averse. However, the implications for practice included ideas about what might increase the possibilities for adopting recovery approaches across disciplines. © 2012 The British Psychological Society.

  2. Violence Risk Assessment and Management in Outpatient Clinical Practice.

    PubMed

    Kivisto, Aaron J

    2016-04-01

    The aims of this review were to highlight fundamental distinctions between risk assessment in forensic versus therapeutic settings, review the best available evidence regarding key risk and protective factors for violence of particular relevance to clinicians in outpatient therapeutic settings, and describe an approach to evaluating and managing violence risk in outpatient treatment. An integrative literature review was undertaken to examine violence risk and protective factors most relevant to outpatient clinicians in therapeutic settings. Based on the available research, the Integrative Outpatient Violence Risk Assessment and Management (IVRAM) model, a 5-step strategy for evaluating and managing violence risk in therapeutic contexts, is introduced. The IVRAM emphasizes the integration of nomothetic and idiographic data through a focus on empirically derived dynamic risk and protective factors in the context of an individualized anamnestic analysis. Clinicians working in forensic and therapeutic settings will increasingly benefit from the contributions of the other as the distinctions between risk assessment and risk management continue to decrease. © 2015 Wiley Periodicals, Inc.

  3. 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.

  4. Concerns about Genetic Testing for Schizophrenia among Young Adults at Clinical High Risk for Psychosis

    PubMed Central

    Lawrence, Ryan E.; Friesen, Phoebe; Brucato, Gary; Girgis, Ragy R.; Dixon, Lisa

    2016-01-01

    Background Genetic tests for schizophrenia may introduce risks and benefits. Among young adults at clinical high-risk for psychosis, little is known about their concerns and how they assess potential risks. Methods We conducted semi-structured interviews with 15 young adults at clinical high-risk for psychosis to ask about their concerns. Results Participants expressed concerns about test reliability, data interpretation, stigma, psychological harm, family planning, and privacy. Participants’ responses showed some departure from the ethics literature insofar as participants were primarily interested in reporting their results to people to whom they felt emotionally close, and expressed little consideration of biological closeness. Additionally, if tests showed an increased genetic risk for schizophrenia, four clinical high-risk persons felt obligated to tell an employer and another three would “maybe” tell an employer, even in the absence of clinical symptoms. Conclusions These findings suggest opportunities for clinicians and genetic counselors to intervene with education and support. PMID:27529075

  5. Cancer worries, risk perceptions and associations with interest in DNA testing and clinic satisfaction in a familial colorectal cancer clinic.

    PubMed

    Collins, V; Halliday, J; Warren, R; Williamson, R

    2000-12-01

    Multi-disciplinary familial cancer clinics are becoming an integral part of cancer services. It is, therefore, important to assess how attendance at these clinics impacts on cancer-related concerns, risk perceptions and behavioural intentions, and how the clinic services are being received by those using them. This study has assessed a familial colorectal cancer clinic with respect to cancer-related worries and risk perceptions and their impact on interest in DNA testing and overall satisfaction with the clinic. Pre- and post-clinic questionnaires were completed by 127 patients and relatives attending the clinic. After attending the clinic, the proportion of people 'very' or 'extremely' worried about developing bowel cancer reduced from 49 (pre-clinic) to 34% (p = 0.002). Worry about bowel cancer was positively associated with younger age, higher education level and higher perceived risk of developing cancer. A reduction in level of risk perception correlated with a lower likelihood of feeling 'very worried' about developing bowel cancer. Of those intending to go ahead with DNA testing, 58% were 'very worried' about bowel cancer compared with 15% of those not intending to proceed with testing, suggesting that worry was a motivation for interest in DNA testing. One-third of participants indicated another session of genetic counselling would be helpful. Within this group, a higher proportion was very worried about bowel cancer (43%) than for those who did not want another session (17%). Attendance at this familial colorectal cancer clinic alleviated worry for many individuals, partly due to improved information about risk of colorectal cancer.

  6. An evaluation of clinical risk factors for estimating fracture risk in postmenopausal osteoporosis using an electronic medical record database.

    PubMed

    Unni, S; Yao, Y; Milne, N; Gunning, K; Curtis, J R; LaFleur, J

    2015-02-01

    Many of the clinical risk factors used in fracture risk assessment (FRAX) calculator are available in electronic medical record (EMR) databases and are good sources of osteoporosis risk factor information. The EPIC EMR database showed a lower prevalence of FRAX risk factors and, consequently, proportion of patients who would be deemed "high risk." The FRAX tool is underutilized for osteoporosis screening. Many of the clinical risk factors for FRAX may be available in EMR databases and may enable health systems to perform fracture risk assessments. We intended to identify variables in an EMR database for calculating FRAX score in a cohort of postmenopausal women, to estimate absolute fracture risk, and to determine the proportions of women whose absolute fracture risks exceed the National Osteoporosis Foundation (NOF) thresholds. Our cohort was selected using an EMR database with demographic, inpatient, outpatient, and clinical information for female patients age≥50 in a family practice, internal medicine, or obstetrics/gynecology clinic in 2007-2008. The latest physician encounter was the index date. Variables, problem and medication lists, diagnosis codes, and histories from the EMR were used to populate the 11 clinical risk factor variables used in the FRAX. These risk factor prevalence and treatment-eligible proportions were compared to those of published epidemiology studies. The study included 345 patients. Mean (SD) 10-year risk for any major fracture was 11.1% (6.8) when bone mineral density (BMD) was used and 11.2% (6.5) when BMI was used. About 10.1% of the cohort exceeded the NOF's 20% major fracture risk threshold and 32.5% exceeded the NOF's 3% hip fracture risk threshold when BMD was used. Overall, the number of treatment-eligible patients was slightly lower when FRAX was calculated using BMD versus BMI (13.6 and 36.8%). Our cohort using EMR data most likely underestimated the mean 10-year probability of any major fracture compared to other cohorts

  7. 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. © 2014 The Authors. Sociology of Health & Illness © 2014 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

  8. 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

  9. 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…

  10. 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…

  11. 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

  12. [The classification and risk analysis of clinical claims for mechanical ventilator].

    PubMed

    Liu, Yanwu; Wang, Ruitong; Xiao, Shengchun; Wang, Weidong

    2011-08-01

    The risk analysis of clinical claims of mechanical ventilator can provide the useful information to the application of the availability and safety of mechanical ventilators. This paper classifies the clinical claims of two types of mechanical ventilations, and tries to find the distribution characteristics of the failure rate of the clinical claims by using the hazard analysis method. All of the distribution characteristics are related to the factors as ventilator design, environment human factors, etc. The method of risk analysis, combining with the classification of clinical claims, is useful for the clinical application and engineering services of mechanical ventilation.

  13. Violence risk prediction. Clinical and actuarial measures and the role of the Psychopathy Checklist.

    PubMed

    Dolan, M; Doyle, M

    2000-10-01

    Violence risk prediction is a priority issue for clinicians working with mentally disordered offenders. To review the current status of violence risk prediction research. Literature search (Medline). Key words: violence, risk prediction, mental disorder. Systematic/structured risk assessment approaches may enhance the accuracy of clinical prediction of violent outcomes. Data on the predictive validity of available clinical risk assessment tools are based largely on American and North American studies and further validation is required in British samples. The Psychopathy Checklist appears to be a key predictor of violent recidivism in a variety of settings. Violence risk prediction is an inexact science and as such will continue to provoke debate. Clinicians clearly need to be able to demonstrate the rationale behind their decisions on violence risk and much can be learned from recent developments in research on violence risk prediction.

  14. 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…

  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. Hyperuricemia as a risk factor for cardiovascular disease: clinical review.

    PubMed

    Gudiño Gomezjurado, Álvaro

    2016-11-15

    Cardiovascular diseases are one of the most important causes of morbidity and mortality worldwide. Several risk factors have been associated with the development of these pathologies. However, there is controversy about whether hyperuricemia is an independent risk factor for developing cardiovascular disease. To answer this question, we performed a recent literature review of relevant published material to assess the association of hyperuricemia with four major cardiovascular diseases: hypertension, coronary heart disease, heart failure and atrial fibrillation.

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

    PubMed

    Tudur Smith, Catrin; Williamson, Paula; Jones, Ashley; Smyth, Alan; Hewer, Simon Langton; Gamble, Carrol

    2014-04-16

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

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

    PubMed Central

    2014-01-01

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

  19. Nurse Practitioner Perceptions of a Diabetes Risk Assessment Tool in the Retail Clinic Setting.

    PubMed

    Marjama, Kristen L; Oliver, JoAnn S; Hayes, Jennifer

    2016-10-01

    IN BRIEF This article describes a study to gain insight into the utility and perceived feasibility of the American Diabetes Association's Diabetes Risk Test (DRT) implemented by nurse practitioners (NPs) in the retail clinic setting. The DRT is intended for those without a known risk for diabetes. Researchers invited 1,097 NPs working in the retail clinics of a nationwide company to participate voluntarily in an online questionnaire. Of the 248 NPs who sent in complete responses, 114 (46%) indicated that they used the DRT in the clinic. Overall mean responses from these NPs indicated that they perceive the DRT as a feasible tool in the retail clinic setting. Use of the DRT or similar risk assessment tools in the retail clinic setting can aid in the identification of people at risk for type 2 diabetes.

  20. Incisional hernia in the elderly: risk factors and clinical considerations.

    PubMed

    Caglià, Pietro; Tracia, Angelo; Borzì, Laura; Amodeo, Luca; Tracia, Lucio; Veroux, Massimiliano; Amodeo, Corrado

    2014-01-01

    Ventral incisional hernia is a common complication of abdominal surgery. The marked improvements in medical technology and healthcare, lead to an increasing number of elderly patients to take advantage of even complex surgical procedures. The objective of this literature review was to analyze the risk factors for ventral incisional hernia in elderly patients and to identify measures that might decrease the incidence of this complication. An analysis of the surgical literature was performed using the search engines EMBASE, Cochrane Library, and PubMed with particular reference to elderly patients using the keywords: abdominal hernia, wound dehiscence, incisional hernia, incidence, trocar site hernia, and hernia prevention. In our opinion the risk factors for incisional hernia should be separately considered. First those related to the patients and to the abdominal surgery and, in addition, those related to the surgery of the abdominal wall defects. Reparative surgery of the abdominal wall, to date uniquely characterized by the use of the mesh, should be considered an additional risk factor for the occurrence of incisional hernia. However, the low incarceration risk, the risk of recurrence, the relevant rate of postoperative pain and discomfort and complications associated with mesh repair, as small bowel obstruction, mesh infection, and entero-cutaneous fistula, suggest that the general indication for surgical treatment of incisional hernias, in a symptomatic or oligosymptomatic elderly patients, should be critically reconsidered in order to avoid unnecessary surgery. Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  1. Risk management in clinical practice. Part 10. Periodontology.

    PubMed

    Baker, P; Needleman, I

    2010-12-11

    A sizeable proportion of patients in clinical practice will have some form of periodontal disease and most of these patients can be well managed in primary care. Unfortunately, dento-legal claims regarding inappropriate periodontal care are increasing rapidly and are now one of the most common reasons for litigation in dentistry. In this paper we will look at aspects of contemporary management of periodontal disease in clinical practice and offer guidance for examination, management and referral.

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

    PubMed Central

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

    2015-01-01

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

  3. The validity of behavioral data reported by injection drug users on a clinical risk assessment.

    PubMed

    Morrison, C S; McCusker, J; Stoddard, A M; Bigelow, C

    1995-05-01

    The validity of drug and sexual behavior data collected by drug user treatment staff using a short clinical risk assessment among 387 injection drug users is evaluated using in-depth, confidential interview process. Moderate to high agreement levels were found for most, but not all, variables. Participants consistently reported less risky behaviors on the clinical risk assessment than on the in-depth interview. More easily recalled information can be accurately gathered through a short clinical risk assessment. However, in-depth, confidential interviewing is important when gathering self-reports of the frequency of drug and sexual behaviors.

  4. Clinical utility of a novel coronary heart disease risk-assessment test to further classify intermediate-risk patients.

    PubMed

    Solomon, Matthew D; Tirupsur, Ahalya; Hytopoulos, Evangelos; Beggs, Michael; Harrington, Douglas S; French, Cynthia; Quertermous, Thomas

    2013-10-01

    Current coronary heart disease (CHD) risk assessments inadequately assess intermediate-risk patients, leaving many undertreated and vulnerable to heart attacks. A novel CHD risk-assessment (CHDRA) tool was developed for intermediate-risk stratification using biomarkers and established risk factors to significantly improve CHD risk discrimination. Physicians will change their treatment plan in response to more information about a patient's CHD risk level provided by the CHDRA test. A Web-based survey of cardiology, internal medicine, family practice, and obstetrics/gynecology physicians (n = 206) was conducted to assess the CHDRA clinical impact. Each physician was shown 3 clinical vignettes representing community-based cohort participants randomly selected from 8 total vignettes. For each, the physicians assessed the individual's CHD risk and selected preferred therapies based on the individual's comorbidities, physical examination, and laboratory results. The individual's CHDRA score was then provided and the physicians were queried for changes to their initial treatment plans. After obtaining the CHDRA result, 70% of the physician responses indicated a change to the patient's treatment plan. The revised lipid-management plans agreed more often (74.6% of the time) with the current Adult Treatment Panel III guidelines than did the original plans (57.6% of the time). Most physicians (71.3%) agreed with the statement that the CHDRA result provided information that would impact their current treatment decisions. The CHDRA test provided additional information to which physicians responded by more often applying appropriate therapy and actions aligned with guidelines, thus demonstrating the clinical utility of the test. © 2013 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

  5. Risk-factor assessment for falls: from a written checklist to the penless clinic.

    PubMed

    Dyer, C A; Watkins, C L; Gould, C; Rowe, J

    1998-09-01

    to audit risk-factor identification of fallers before and after an education programme and the insertion of a written checklist in medical notes. Risk-factor identification in a dedicated, computerized falls clinic was then examined. documentation of risk factors for falls was studied on wards and a self-auditing 'penless' clinic for fallers subsequently set up to generate reports for medical notes and letters for general practitioners. risk-factor identification improved after the insertion of the checklist but remained relatively poor. A dedicated clinic allowed almost complete identification of risk factors. Of the first 112 patients (median age 82) seen in the clinic, 75 (67%) were housebound. Remediable risk factors--e.g. inappropriate medication (67%), unsatisfactory footwear (59%) and postural hypotension (17%)--were found in most. Thirty-three patients (29%) had difficulty with alarm raising. ward-based intervention showed limited capacity to identify risk factors for falls: a dedicated clinic was more successful. The use of a portable computer with a programme to screen fallers for risk factors is worthy of consideration.

  6. Stroke in Women: Risk Factors and Clinical Biomarkers.

    PubMed

    Mirzaei, Hamed

    2017-05-12

    Stroke has been emerged as one of major health problems for women worldwide. Increasing of knowledge in this field has provided new data in this area which contribute to finding of new risk factors and could improve stroke treatment. A large number studies indicated a variety of risk factors including sex, age, race, smoking, diabetes, and physical inactivity could be involved in stroke in women. The understanding of various aspects involved in women stroke including risk factors, outcomes, stroke recovery, and prevention could provide new therapeutic platforms which could likely lead to better treatment in women stroke. Diagnosis is one of important steps in stroke therapy. It has been showed that a variety of biomarkers such as microRNAs (miRNAs), tPA, and von willebrand factor could be used as therapeutic and diagnostic biomarkers in stroke therapy. Here, we summarized various aspects of stroke in women which could help to recognition risk factors, outcomes, care, treatment, and novel biomarkers involve in treatment of stroke. J. Cell. Biochem. 9999: 1-12, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  7. 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

  8. Managing risks in professional and clinical performance dilemmas: Part II.

    PubMed

    Schwab, N C; Pohlman, K J

    2000-08-01

    The primary purpose of the second article in this 2-part series is to describe and illustrate the use of an analytical framework that may assist school nurses to approach and resolve the dilemmas they may face in practice. Part I of the article was published in the April issue of this journal. It defined the terms "professional performance issue" and "clinical performance issue" and described a 5-step framework for analyzing practice dilemmas related to clinical and performance issues. In this article, the framework will be applied to a specific case scenario involving unsafe staffing and delegation.

  9. Designing clinical and genetic guidelines of colorectal cancer screening as an effective roadmap for risk management

    PubMed Central

    Zali, Mohammad Reza; Safdari, Reza; Maserat, Elham; Asadzadeh Aghdaei, Hamid

    2016-01-01

    Aim: We aimed to present clinical and genetic guidelines of colorectal cancer screening for risk assessment of populations at risk. Background: National guidelines can be used as a guide for choosing the method of screening for each individual. These guidelines facilitate decision making and support the delivery of cancer screening service. Methods: In the first step, a comparative study was performed by using secondary data extracted from the literature review. Three countries (Canada, Australia and United States) were selected from 25 countries that are member in the International Cancer Screening Network (ICSN). The second step of study was qualitative survey. The study was based on the grounded theory approach. Study tool was semi-structured interview. Interviewing involves asking questions and getting answers from participants. 22 expert’s perspectives about guidelines of colorectal cancer screening were surveyed. Results: Screening program of selected countries was compared. Countries were surveyed by number of risk groups and subgroups, criteria for risk assessment, beginning age, recommendations, screening approaches and intervals. Australia and United States have three risk groups and Canada has two risk groups. Four risk groups were defined in the national guideline, including high risk, increased risk, average and low risk group. The high risk group comprises of 8 subgroups, increased risk group comprises of 3 subgroups and average risk group contain 4 subgroups. Approved clinical criteria for hereditary syndromes and the roadmap of genetic and pathologic survey were designed. Conclusions: Guidelines and pathways have a vital role in the quality improvement of CRC screening program. National guidelines were refined according to the environmental and genetic criteria of colorectal cancer in Iran. These guidelines provide evidence-based recommendations by risk groups. National pathways as a risk assessment tool can evaluate and improve the processes and

  10. 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.

  11. Quinolone-resistant Campylobacter infections: risk factors and clinical consequences.

    PubMed

    Engberg, Jørgen; Neimann, Jakob; Nielsen, Eva Møller; Aerestrup, Frank Møller; Fussing, Vivian

    2004-06-01

    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.

  12. Risk management in clinical practice. Part 8. Temporomandibular disorders.

    PubMed

    Gray, R; Al-Ani, Z

    2010-11-01

    Temporomandibular disorders can arise apparently idiopathically, as a result of macro-trauma or micro-trauma such as parafunction, as a result of a separate disease process or as a consequence of dental treatment. The objectives of this chapter are to make the practitioner aware of his/her responsibilities in any of these situations. Precise record keeping and careful risk management are essential. Guidelines are given to protect not only the practitioner but also the patient.

  13. Clinical risk factors for bipolar disorders: a systematic review of prospective studies.

    PubMed

    Faedda, Gianni L; Serra, Giulia; Marangoni, Ciro; Salvatore, Paola; Sani, Gabriele; Vázquez, Gustavo H; Tondo, Leonardo; Girardi, Paolo; Baldessarini, Ross J; Koukopoulos, Athanasios

    2014-10-01

    Early phases and suspected precursor states of bipolar disorder are not well characterized. We evaluate the prevalence, duration, clinical features and predictive value of non-affective psychopathology as clinical risk factors for bipolar disorder in prospective studies. We screened PubMed, CINAHL, PsycINFO, Embase, SCOPUS, and ISI-Web of Science databases from inception up to January 31, 2014, following PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and searched: bipolar disorder AND [antecedent⁎ OR predict⁎ OR prodrom⁎ OR prospect⁎ OR risk⁎] AND [diagnosis OR development]. We included only English language reports on prospective, longitudinal studies with two structured clinical assessments (intake and follow-up); no DSM intake diagnosis of bipolar-I or -II; diagnostic outcome was bipolar-I or -II. Details of study design, risk factors, and predictive value were tabulated. We found 16 published reports meeting selection criteria, with varying study design. Despite heterogeneity in methods, findings across studies were consistent. Clinical risk factors of bipolar disorder were early-onset panic attacks and disorder, separation anxiety and generalized anxiety disorders, conduct symptoms and disorder, ADHD, impulsivity and criminal behavior. Since risk factors identified in some prospective studies are predictive of other conditions besides bipolar disorder, these preliminary findings require replication, and their sensitivity, specificity and predictive value need to be assessed. Clinical risk factors for bipolar disorder typically arise years prior to syndromal onset, include anxiety and behavioral disorders with unclear sensitivity and specificity. Prospectively identified clinical risk factors for bipolar disorder are consistent with retrospective and family-risk studies. Combining clinical risk factors with precursors and family-risk may improve early identification and timely and appropriate treatment of

  14. Clinical variables of preoperative risk in thoracic surgery.

    PubMed

    Saad, Ivete Alonso Bredda; De Capitani, Eduardo Mello; Toro, Ivan Felizardo Contrera; Zambon, Lair

    2003-05-05

    Pulmonary complications are the most common forms of postoperative morbidity in thoracic surgery, especially atelectasis and pneumonia. The first step in avoiding these complications during the postoperative period is to detect the patients that may develop them. To identify risk variables leading to early postoperative pulmonary complications in thoracic surgery. Prospective study. Hospital das Clínicas, Faculdade de Ciências Médicas, Universidade Estadual de Campinas. 145 patients submitted to elective surgery were classified as low, moderate and high risk for postoperative pulmonary complications using a risk assessment scale. The patients were followed up for 72 hours after the operation. Postoperative pulmonary complications were defined as atelectasis, pneumonia, tracheobronchitis, wheezing, prolonged intubation and/or prolonged mechanical ventilation. Univariate analysis was applied in order to study these independent variables: age, nutritional status, body mass index, respiratory disease, smoking habit, spirometry and surgery duration. Multivariate logistic regression analysis was performed in order to evaluate the relationship between independent and dependent variables. The incidence of postoperative complications was 18.6%. Multivariate logistic regression analysis showed that the variables increasing the chances of postoperative pulmonary complications were wheezing (odds ratio, OR = 6.2), body mass index (OR = 1.15), smoking (OR = 1.04) and surgery duration (OR = 1.007). Wheezing, body mass index, smoking and surgery duration increase the chances of postoperative pulmonary complications in thoracic surgery

  15. The Risk and Clinical/Molecular Characteristics of Breast Cancer in Women with Neurofibromatosis Type 1

    DTIC Science & Technology

    2014-10-01

    Award Number: W81XWH-11-1-0671 TITLE: The Risk and Clinical/Molecular Characteristics of Breast Cancer in Women with...4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER “The Risk and Clinical/Molecular Characteristics of Breast Cancer in Women with...Unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT: The purpose of the project is to characterize the breast cancer in women affected with

  16. [Introduction of innovative high-risk medical devices in Europe: are clinical efficacy and safety guaranteed?].

    PubMed

    Stordeur, S; Vinck, I; Neyt, M; Van Brabandt, H; Hulstaert, F

    2013-04-01

    Innovative high-risk medical devices, such as new types of heart valves or hip prostheses, become available on the European market more rapidly than in USA. This is due to the European legislation allowing early marketing of innovative high-risk medical devices before high-quality clinical evidence is obtained from randomized controlled trials. We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the USA. We also discussed patient safety and the transparency of information. The literature and regulatory documents were checked. Representatives from industry, competent authorities, notified bodies, ethics committees, and health technology assessment agencies were consulted. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. For the patient, this implies earlier access to innovative technology, but at the risk of potential safety issues. At this moment, European requirements for clinical studies are lower for medical devices than for drugs, and data from premarket clinical trials are scarce or remain unpublished. The European Medical Device Directives are currently being reworked. For innovative high-risk devices, and while awaiting a reworked Medical Device Directive, patient risk should be minimized by limiting the market introduction of novel high-risk devices with minimal clinical data to physicians with the necessary training and expertise. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  17. 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...

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

    USDA-ARS?s Scientific Manuscript database

    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...

  19. Using the Clinical Interview and Curriculum Based Measurement to Examine Risk Levels

    ERIC Educational Resources Information Center

    Ginsburg, Herbert P.; Lee, Young-Sun; Pappas, Sandra

    2016-01-01

    This paper investigates the power of the computer guided clinical interview (CI) and new curriculum based measurement (CBM) measures to identify and help children at risk of low mathematics achievement. We use data from large numbers of children in Kindergarten through Grade 3 to investigate the construct validity of CBM risk categories. The basic…

  20. Using the Clinical Interview and Curriculum Based Measurement to Examine Risk Levels

    ERIC Educational Resources Information Center

    Ginsburg, Herbert P.; Lee, Young-Sun; Pappas, Sandra

    2016-01-01

    This paper investigates the power of the computer guided clinical interview (CI) and new curriculum based measurement (CBM) measures to identify and help children at risk of low mathematics achievement. We use data from large numbers of children in Kindergarten through Grade 3 to investigate the construct validity of CBM risk categories. The basic…

  1. Assessment of violence risk in youth for juvenile court: relevant factors for clinical judgment.

    PubMed

    Duits, Nils; Doreleijers, Theo A H; van den Brink, Wim

    2008-01-01

    Assessment of violence risk in youth for juvenile court needs to be improved. To determine which items of the Structured Assessment of Violence Risk in Youth (SAVRY) are recorded in pre-trial mental health evaluations and which of these items are associated with the clinical judgment of the risk of violent recidivism. A total of one hundred forensic diagnostic juvenile court files were rated with regard to the presence or absence of the thirty SAVRY risk items: ten historical, six contextual and eight individual items, and six protective items. Univariate and multivariate logistic regression analysis were used to examine the relationship between SAVRY risk items and the clinical judgment of violence risk. Most SAVRY-items had been recorded in the files. However, five historical items and the contextual item 'rejection by peers' did not appear in 25-62% of the files. Especially SAVRY items like 'negative-attitudes' and 'psychopathic traits' were the most powerful predictors for clinical judgment of high violence risk. Unexpectedly, historical items played a minor role in clinical judgment. Prospective research is needed with the use of SAVRY-items to improve evidence based violence risk assessment in court ordered mental health evaluations of youngsters.

  2. Psychological and physical pain as predictors of suicide risk: evidence from clinical and neuroimaging findings.

    PubMed

    Rizvi, Sakina J; Iskric, Adam; Calati, Raffaella; Courtet, Philippe

    2017-03-01

    Suicide is a multidimensional clinical phenomenon with complex biological, social and psychological risk factors. Therefore, it is imperative for studies to focus on developing a unified understanding of suicide risk that integrates current clinical and neurobiological findings. A recent line of research has implicated different classifications of pain in understanding suicide risk, including the concepts of psychache and pain tolerance. Although psychache is defined as the experience of unbearable psychological pain, pain tolerance refers to the greatest duration or intensity of painful stimuli that one is able to bear. This review will focus on integrating current clinical and neurobiological findings by which psychache and pain tolerance confer suicide risk. Results indicate that psychache has been identified as a significant risk factor for suicide and that psychache may be associated with the neurocircuitry involved in the modulation of physical pain. Converging evidence has also been found linking pain tolerance to self-injurious behaviours and suicide risk. The experience of psychache and physical pain in relation to other predictors of suicide, including reward processing, hopelessness and depression, are further discussed. Future research examining the pain-suicide connection is required to understand the mechanism behind clinically relevant risk factors for suicide, which can ultimately inform the construction of empirically supported suicide risk assessment and intervention techniques.

  3. 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…

  4. 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...

  5. 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…

  6. Risk management in clinical practice. Part 4. Endodontics.

    PubMed

    Webber, J

    2010-08-28

    Endodontic procedures are challenging and technically demanding. In the UK standards of treatment have been shown to have fallen short of acceptable guidelines, laying many dentists open to litigation on questions of clinical negligence by patients who understand and know what should be considered as current best practice in this area. Failure to communicate with patients about the procedure and not obtaining consent for treatment is a key area of complaint, as is inadequate record keeping. When treatment is undertaken within the framework of accepted guidelines it would be very difficult for a patient to open a claim for clinical negligence should a failure occur. This article looks at potential dento-legal problems in endodontics and how, through compliance with best practice, they may be avoided.

  7. Risk assessment scores for patients with upper gastrointestinal bleeding and their use in clinical practice.

    PubMed

    Waddell, Katy M; Stanley, Adrian J

    2015-01-01

    Upper gastrointestinal bleeding (UGIB) is a common cause for emergency admission to hospital representing a significant clinical as well as economic burden. UGIB encompasses a wide range of severities from life-threatening exsanguination to minor bleeding that may not require hospital admission. Patients with UGIB are often initially assessed and managed by junior doctors and non-gastroenterologists. Several risk scores have been created for the assessment of these patients, some requiring endoscopic data for calculation and others that are calculable from clinical data alone. A key question in clinical practice is how to accurately identify patients with UGIB at high risk of adverse outcome. Patients considered high risk are more likely to experience adverse outcomes and will require urgent intervention. In contrast, those patients with UGIB who are considered to be low risk could potentially be managed on an outpatient basis. The Glasgow Blatchford Score (GBS) appears best at identifying patients at low risk of requiring intervention or death and therefore may be best for use in clinical practice, allowing outpatient management in low risk cases. There has been some debate as to the optimal GBS cut-off score for safely identifying this low-risk group. Many guidelines suggest that patients with a GBS of zero can be safely managed as outpatients, but more recent studies have suggested that this threshold could potentially be safely increased to ≤1. Most other patients require inpatient endoscopy within 24 h and the full Rockall score remains important for risk assessment following endoscopy, particularly as it includes the endoscopic diagnosis. A minority of patients will require emergency endoscopy following resuscitation, but at present there is no evidence that risk scores can accurately identify this very high-risk group. Studies have shown the latest risk assessment score, the AIMS65, looks promising in the prediction of mortality. However, to date there is

  8. A Clinically Detailed Risk Information System for Cost

    PubMed Central

    Carter, Grace M.; Bell, Robert M.; Dubois, Robert W.; Goldberg, George A.; Keeler, Emmett B.; McAlearney, John S.; Post, Edward P.; Rumpel, J. David

    2000-01-01

    The authors discuss a system that describes the resources needed to treat different subgroups of the population under age 65, based on burden of disease. It is based on 173 conditions, each with up to 3 severity levels, and contains models that combine prospective diagnoses with retrospectively determined elements. We used data from four different payers and standardized the cost of most services. Analyses showed that the models are replicable, are reasonably accurate, explain costs across payers, and reduce rewards for biased selection. A prospective model with additional payments for birth episodes and for serious problems in newborns would be an effective risk adjuster for Medicaid programs. PMID:11481768

  9. Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

    PubMed Central

    2012-01-01

    Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis) we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding) and benefit (thrombosis averted) were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance. PMID:22233221

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

    PubMed

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

    2013-10-01

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

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

    PubMed

    Wada, Kyoko; Nisker, Jeff

    2015-10-01

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

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

    PubMed

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

    2015-10-01

    Institutional review boards, which are charged with overseeing research, must classify the riskiness of proposed research according to a federal regulation known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration codified in 21 CFR 50. If an institutional review board determines that a clinical trial constitutes "minimal risk," there are important practical implications: the institutional review board may then allow a 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 institutional review boards using an expedited process. However, it is unclear how institutional review boards should assess the risk levels of pragmatic clinical trials. 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 article, we examine the common interpretations of research regulations regarding minimal-risk classifications and suggest that they 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 pragmatic clinical trial. We then examine two pragmatic clinical trials and consider how various factors including clinical equipoise, practice variation, research methods such as cluster randomization, and patients' perspectives may contribute to current and evolving concepts of minimal-risk determinations, and how this understanding in turn affects the design and conduct of pragmatic clinical trials.

  13. [Myocardial infarction in women: risk factors and clinical features].

    PubMed

    Fedorova, E L; Bondareva, Z G; Kuimov, A D; Nesterenko, E V

    2003-01-01

    The course of myocardial infarction (MI) in women, especially 60 years of age and older, is characterized by such severe complications as cardiorrhexis, hypovolemic cardiogenic shock, asystole, recurrent ventricular fibrillation and electromechanic dissociation responsible for the majority of lethal outcomes. Especially high MI lethality is in women at the age 70-79 years who have also the highest incidence of recurrent macrofocal MI while small-focal MI occurs in women over 80 years of age (80-89) more frequently than in 60-year-olds and younger. Dominating MI risk factors in women were the following: arterial hypertension detected in 81% patients under 60 and 90.8% cases over 60 years; abnormal lipid spectrum of blood including hypercholesterolemia (HCE), hypertriglyceridemia (HTE) and low concentration of HDLP cholesterol. HCE and HTE closely correlated with abdominal obesity irrespectively of age. Early menopause in women under 60 and diabetes mellitus of type 2 in older women, accumulation of two and more factors of risk contribute to development of coronary heart disease and MI, in females.

  14. [Clinical observation of newborns with infection risk: A safe practice].

    PubMed

    Escribano García, Carla; Montejo Vicente, María Del Mar; Izquierdo Caballero, Raquel; Samaniego Fernández, Carmen María; Marín Urueña, Sara Isabel; Infante López, María Elena; Caserío Carbonero, Sonia

    2017-06-16

    Early-onset neonatal sepsis refers to an infection which starts during the first 72hours of birth, and can lead to significant morbidity and mortality. Scientific evidence shows that infected infants present with symptoms during the first hours after delivery. There has been a significant decrease in this condition with the implementation of guidelines for its prevention. However, International guidelines still recommend the evaluation of these infants using painful tests. A prospective cohort study was conducted on all asymptomatic infants born at>35 weeks gestation with one or more risk factors in a single tertiary care centre from 2011 to 2015. They were periodically observed in newborn nursery from admission until discharge looking for signs of infection. Out of the 9,424 babies born during this period, 1425 were included in the study. A total of 53 infants were admitted to the neonatal unit, half of them because of sepsis suspicion. Finally, just 7 were discharged with the diagnosis of sepsis. All these 7 presented with symptoms during their first 72hours of life. No sepsis was reported in asymptomatic infants. Truly infected infants present with symptoms during their first hours of life. This study supports the observation of infants at risk as a safe practice to detect early-onset sepsis. Copyright © 2017. Publicado por Elsevier España, S.L.U.

  15. 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.

  16. Inpatient Standards of Care and the Suicidal Patient Part II: An Integration with Clinical Risk Management.

    ERIC Educational Resources Information Center

    Silverman, Morton M.; And Others

    1994-01-01

    Elaborates on standards of care for assessment, management, and treatment of hospitalized suicidal patients. Attempts to synthesize concepts of minimal standard of care with clinical risk management and clinical judgment. Points out areas of overlap and shows where optimum care diverges from legal standards of care. Tables differentiate…

  17. 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 HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 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 HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical...

  19. 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 minimal risk. 50.51 Section 50.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical...

  20. 21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 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 HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical...

  1. 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 minimal risk. 50.51 Section 50.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical...

  2. A probabilistic topic model for clinical risk stratification from electronic health records.

    PubMed

    Huang, Zhengxing; Dong, Wei; Duan, Huilong

    2015-12-01

    Risk stratification aims to provide physicians with the accurate assessment of a patient's clinical risk such that an individualized prevention or management strategy can be developed and delivered. Existing risk stratification techniques mainly focus on predicting the overall risk of an individual patient in a supervised manner, and, at the cohort level, often offer little insight beyond a flat score-based segmentation from the labeled clinical dataset. To this end, in this paper, we propose a new approach for risk stratification by exploring a large volume of electronic health records (EHRs) in an unsupervised fashion. Along this line, this paper proposes a novel probabilistic topic modeling framework called probabilistic risk stratification model (PRSM) based on Latent Dirichlet Allocation (LDA). The proposed PRSM recognizes a patient clinical state as a probabilistic combination of latent sub-profiles, and generates sub-profile-specific risk tiers of patients from their EHRs in a fully unsupervised fashion. The achieved stratification results can be easily recognized as high-, medium- and low-risk, respectively. In addition, we present an extension of PRSM, called weakly supervised PRSM (WS-PRSM) by incorporating minimum prior information into the model, in order to improve the risk stratification accuracy, and to make our models highly portable to risk stratification tasks of various diseases. We verify the effectiveness of the proposed approach on a clinical dataset containing 3463 coronary heart disease (CHD) patient instances. Both PRSM and WS-PRSM were compared with two established supervised risk stratification algorithms, i.e., logistic regression and support vector machine, and showed the effectiveness of our models in risk stratification of CHD in terms of the Area Under the receiver operating characteristic Curve (AUC) analysis. As well, in comparison with PRSM, WS-PRSM has over 2% performance gain, on the experimental dataset, demonstrating that

  3. Mooren ulcer in South India: serology and clinical risk factors.

    PubMed

    Zegans, M E; Srinivasan, M; McHugh, T; Whitcher, J P; Margolis, T P; Lietman, T; Jennette, J C; Cunningham, E T

    1999-08-01

    To investigate the rate of undiagnosed rheumatologic diseases and hepatitis C infection among patients with the clinical diagnosis of Mooren ulcer seen at Aravind Eye Hospital, Madurai, South India. Twenty-one patients with the clinical diagnosis of Mooren ulcer and 44 control patients underwent a complete ophthalmic history and examination, as well as serologic testing for antinuclear antibodies, rheumatoid factor, antineutrophil cytoplasmic antibodies, herpes simplex virus 1 antibodies, and hepatitis C virus antibodies. There were no statistically significant differences in the rates of seropositivity for antinuclear antibodies, rheumatoid factor, antineutrophil cytoplasmic antibodies, herpes simplex virus 1 antibodies, and hepatitis C virus antibodies between patients with Mooren ulcer and control patients. Two patients with Mooren ulcer and four control patients were found to have a rheumatoid factor titer of greater than 1:20. One of the control patients, but none of the patients with Mooren ulcer, was found to have serologic evidence of hepatitis C infection. A history of corneal trauma, surgery, or infection was reported by 68% of patients with Mooren ulcer, compared with 20% of control patients (P < .001). Among patients with Mooren ulcer, bilateral disease occurred in 37% of patients, visual acuity was reduced to light perception in 15% of eyes, and perforation occurred in 19% of eyes. Nineteen (90%) of 21 patients with the clinical diagnosis of Mooren ulcer were found to have no evidence of an underlying rheumatologic disease by history, examination, or serologic testing, and none was seropositive for hepatitis C. However, patients with Mooren ulcer were more likely than control patients to report a history of corneal trauma, surgery, or infection.

  4. [Clinical characteristics, progression and risk factors of geographic atrophy].

    PubMed

    Brinkmann, C K; Adrion, C; Mansmann, U; Schmitz-Valckenberg, S; Holz, F G

    2010-11-01

    Geographic atrophy (GA) as the late stage manifestation of age-related macular degeneration (AMD) is a progressive disease process afflicting the retinal pigment epithelium, choriocapillaris and the outer neurosensory retina. GA represents a complex, multifactorial disease governed by the interdependence of genetic, endogenous and exogenous factors. Diagnosis and monitoring of GA progression is largely based on various retinal imaging modalities. After the breakthrough in the treatment of wet AMD GA represents a large clinical challenge. Recent studies have contributed to a better understanding of the pathophysiological pathways, natural history and predictive markers for progression.

  5. Clinical Decision Support for Nurses: A Fall Risk and Prevention Example.

    PubMed

    Lytle, Kathryn S; Short, Nancy M; Richesson, Rachel L; Horvath, Monica M

    2015-12-01

    Clinical decision support tools in electronic health records have demonstrated improvement with process measures and clinician performance, predominantly for providers. Clinical decision support tools could improve patient fall risk identification and prevention plans, a common concern for nursing. This quality-improvement project used clinical decision support to improve the rate of nurse compliance with documented fall risk assessments and, for patients at high risk, fall prevention plans of care in 16 adult inpatient units. Preintervention and postintervention data were compared using quarterly audits, retrospective chart review, safety reports, and falls and falls-with-injury rates. Documentation of fall risk assessments on the 16 units improved significantly according to quarterly audit data (P = .05), whereas documentation of the plans of care did not. Retrospective chart review on two units indicated improvement for admission fall risk assessment (P = .05) and a decrease in the documentation of the shift plan of care (P = .01); one unit had a statistically significant decrease in documentation of plans of care on admission (P = .00). Examination of safety reports for patients who fell showed all patients before and after clinical decision support had fall risk assessments documented. Falls and falls with injury did not change significantly before and after clinical decision support intervention.

  6. 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.

  7. [Risk factors in osteoporosis: clinical and epidemiologic evidence].

    PubMed

    Parra-Cabrera, M S; Hernández-Avila, M; Tamayo Orozco, J A; Fernández Ortega, M C; Meneses, F

    1994-01-01

    The mechanisms of bone loss involve a predominance of osteodestructive cell activity over bone repair. Age and gender are the most significant biological risk factors; perimenopausal women constitute the most susceptible population group. Hormone-related phenomena, such as pregnancies and lactational performance, as well as heredity and ethnic origin, are also associated with osteoporosis. Alcohol and caffeine have been linked with progressive bone demineralization. A reduced body mass increases the probability of fractures. Dietary factors, such as adequate intakes of calcium, phosphates, and vitamin D, exert a protective action while the effect of fluoride and dietary fiber is still controversial. A constant physical activity promotes an appropriate development and maintenance of bone mass and architecture.

  8. Risk factors for obstetric fistula: a clinical review.

    PubMed

    Tebeu, Pierre Marie; Fomulu, Joseph Nelson; Khaddaj, Sinan; de Bernis, Luc; Delvaux, Thérèse; Rochat, Charles Henry

    2012-04-01

    Obstetric fistula is the presence of a hole between a woman's genital tract and either the urinary or the intestinal tract. Better knowledge of the risk factors for obstetric fistula could help in preventing its occurrence. The purpose of this study was to assess the characteristics of obstetric fistula patients. We conducted a search of the literature to identify all relevant articles published during the period from 1987-2008. Among the 19 selected studies, 15 were reports from sub-Saharan Africa and 4 from the Middle East. Among the reported fistula cases, 79.4% to 100% were obstetrical while the remaining cases were from other causes. Rectovaginal fistulae accounted for 1% to 8%, vesicovaginal fistulae for 79% to 100% of cases, and combined vesicovaginal and rectovaginal fistulae were reported in 1% to 23% of cases. Teenagers accounted for 8.9% to 86% of the obstetrical fistulae patients at the time of treatment. Thirty-one to 67% of these women were primiparas. Among the obstetric fistula patients, 57.6% to 94.8% of women labor at home and are secondarily transferred to health facilities. Nine to 84% percent of these women delivered at home. Many of the fistula patients were shorter than 150 cm tall (40-79.4%). The mean duration of labor among the fistula patients ranged from 2.5 to 4 days. Twenty to 95.7% of patients labored for more than 24 h. Operative delivery was eventually performed in 11% to 60% of cases. Obstetric fistula was associated with several risk factors, and they appear to be preventable. This knowledge should be used in strengthening the preventive strategy both at the health facility and at the community level.

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

    PubMed

    Groom, Amy G; Younis, Tallal

    2016-01-01

    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.

  10. Temporal Association of Cannabis Use with Symptoms in Individuals at Clinical High Risk for Psychosis

    PubMed Central

    Corcoran, Cheryl M; Kimhy, David; Stanford, Arielle; Khan, Shamir; Walsh, Julie; Thompson, Judy; Schobel, Scott; Harkavy-Friedman, Jill; Goetz, Ray; Colibazzi, Tiziano; Cressman, Victoria; Malaspina, Dolores

    2008-01-01

    Background Cannabis use is reported to increase the risk for psychosis, but no prospective study has longitudinally examined drug use and symptoms concurrently in clinical high risk cases. Method We prospectively followed for up to 2 years 32 cases who met research criteria for prodromal psychosis to examine the relationship between substance use and clinical measures. Results Cases with a baseline history of cannabis use (41%) were older, but did not differ in clinical measures. Longitudinal assessments showed these cases had significantly more perceptual disturbances and worse functioning during epochs of increased cannabis use that were unexplained by concurrent use of other drugs or medications. Conclusions These data demonstrate that cannabis use may be a risk factor for the exacerbation of sub-threshold psychotic symptoms, specifically perceptual disturbances, in high risk cases. PMID:18809298

  11. [Down with odds ratios: risk ratios in cohort studies and randomised clinical trials].

    PubMed

    Knol, Mirjam J

    2012-01-01

    Various effect measures are available for quantifying the relationship between an intervention or a risk factor and an outcome, such as the risk ratio and the odds ratio. Odds ratios are intended for use in case-control studies in which they are an appropriate measure for estimating the relative risk; however, this measure is also often presented in cohort studies and in randomized clinical trials. When used for cohort studies and randomized clinical trials, the odds ratio is often incorrectly interpreted as the risk ratio; the odds ratio then provides an overestimation of the risk ratio, especially when the outcome is frequent. The use of logistic regression to adjust for confounding is one of the reasons that odds ratios are presented. For cohort studies and randomized clinical trials, however, there are methods to estimate adjusted risk ratios; these include the Mantel-Haenszel method, log-binomial regression, Poisson regression with robust standard error, and 'doubling of cases' method with robust standard error. To avoid misinterpretation of odds ratios, risk ratios should be calculated in cohort studies and randomized clinical trials.

  12. Evaluation of awareness of risk factors for kidney cancer among patients presenting to a urology clinic.

    PubMed

    Parker, Alexander S; Arnold, Michelle L; Diehl, Nancy D; Hassan, Lauren; Thiel, David D

    2014-06-01

    This study aimed to evaluate awareness of risk factors for kidney cancer among patients presenting to a urology clinic. Smoking, obesity and hypertension are widely accepted as risk factors for kidney cancer; however, there are limited data regarding awareness of these risk factors. The researchers prospectively identified 172 patients presenting to a urology clinic between 1 May 2009 and 31 August 2009. Each patient completed a questionnaire that requested responses to whether certain lifestyle factors increased the risk of a variety of cancers. Information on demographics and other covariates was collected via questionnaires and medical chart abstraction. To estimate and compare risk factor awareness levels for different cancers, 95% confidence intervals (95% CIs) were constructed and Fisher's exact tests performed. Logistic regression analysis was used to evaluate covariates associated with risk factor awareness. The percentage reporting that smoking increases the risk of kidney cancer (36%, 95% CI 29-44%) was lower than for lung cancer (96%, 95% CI 92-99%). Similarly, the percentage reporting that obesity increases the risk of kidney cancer (32%, 95% CI 25-40%) was lower than for colon cancer (45%, 95% CI 37-53% CI). Only 18% (95% CI 13-25%) identified hypertension as a risk factor for kidney cancer. Female gender and younger age were associated with increased levels of awareness of the association with smoking and obesity, respectively. The data support a low level of awareness of kidney cancer risk factors and underscore an opportunity for urologists to engage in education efforts.

  13. Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

    PubMed

    Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans

    2012-07-01

    High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

  14. Importance of time in therapeutic range on bleeding risk prediction using clinical risk scores in patients with atrial fibrillation.

    PubMed

    Rivera-Caravaca, José Miguel; Roldán, Vanessa; Esteve-Pastor, María Asunción; Valdés, Mariano; Vicente, Vicente; Lip, Gregory Y H; Marín, Francisco

    2017-09-21

    Bleeding risk with vitamin K antagonists (VKAs) is closely related to the quality of anticoagulation in atrial fibrillation (AF) patients, reflected by time in therapeutic range (TTR). Here we compared the discrimination performance of different bleeding risk scores and investigated if adding TTR would improve their predictive value and clinical usefulness. We included 1361 AF patients stables on VKA for at least 6 months. Bleeding risk was assessed by the HAS-BLED, ATRIA, ORBIT and HEMORR2HAGES scores. Major bleeding events were recorded after a median of 6.5 years follow-up. In this period 250 patients suffered major bleeds. Comparison of receiver operating characteristic (ROC) curves demonstrated that HAS-BLED had the best discrimination performance, but adding the 'labile INR' criteria (i.e. TTR <65%) to ATRIA, ORBIT and HEMORR2HAGES increased their ability of discrimination and predictive value, with significant improvements in reclassification and discriminatory performance. Decision curve analyses (DCA) showed improvements of the clinical usefulness and a net benefit of the modified risk scores. In summary, in AF patients taking VKAs, the HAS-BLED score had the best predictive ability. Adding 'labile INR' to ATRIA, ORBIT and HEMORR2HAGES improved their predictive value for major bleeding leading to improved clinical usefulness compared to the original scores.

  15. Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study.

    PubMed

    Jin, Yuyan; Bies, Robert; Gastonguay, Marc R; Wang, Yaning; Stockbridge, Norman; Gobburu, Jogarao; Madabushi, Rajanikanth

    2014-12-01

    Hypertension control rate in the US is low with the current clinical practice (JNC 7) and cardiovascular disease (CVD) remain is the leading cause of morbidity and mortality. A 6-month clinical trial simulation case study testing different virtual clinical practice strategies was performed in an attempt to increase the control rate. The CVD risk was calculated using the Framingham CVD risk model at baseline and 6 months post-treatment. The estimated CVD events for the baseline patient sample without any treatment was 998 (95% CI: 967-1,026) over 6 months in 100,000 patients. Treating these patients for 6 months with current clinical practice, high dose strategy, high dose with low target BP strategy resulted in a reduction in CVD events of 191(95% CI: 169-205), 284 (95% CI: 261-305), and 353 (95% CI: 331-375), respectively. Hence the two alternative strategies resulted in an increase in treatment effect by 49% (95%CI: 44-59%) and 85% (95%CI: 79-99%), respectively. The increased safety with the current low dose strategy may potentially be offset by increased CVD risk in the time necessary to control hypertension.

  16. Genomic risk profiling: attitudes and use in personal and clinical care of primary care physicians who offer risk profiling.

    PubMed

    Haga, Susanne B; Carrig, Madeline M; O'Daniel, Julianne M; Orlando, Lori A; Killeya-Jones, Ley A; Ginsburg, Geoffrey S; Cho, Alex

    2011-08-01

    Genomic risk profiling involves the analysis of genetic variations linked through statistical associations to a range of disease states. There is considerable controversy as to how, and even whether, to incorporate these tests into routine medical care. To assess physician attitudes and uptake of genomic risk profiling among an 'early adopter' practice group. We surveyed members of MDVIP, a national group of primary care physicians (PCPs), currently offering genomic risk profiling as part of their practice. All physicians in the MDVIP network (N = 356) We obtained a 44% response rate. One third of respondents had ordered a test for themselves and 42% for a patient. The odds of having ordered personal testing were 10.51-fold higher for those who felt well-informed about genomic risk testing (p < 0.0001). Of those who had not ordered a test for themselves, 60% expressed concerns for patients regarding discrimination by life and long-term/disability insurers, 61% about test cost, and 62% about clinical utility. The odds of ordering testing for their patients was 8.29-fold higher among respondents who had ordered testing for themselves (p < 0.0001). Of those who had ordered testing for patients, concerns about insurance coverage (p = 0.014) and uncertain clinical utility (p = 0.034) were associated with a lower relative frequency of intention to order testing again in the future. Our findings demonstrate that respondent familiarity was a key predictor of physician ordering behavior and clinical utility was a primary concern for genomic risk profiling. Educational and interpretive support may enhance uptake of genomic risk profiling.

  17. Risk factors related to heartburn in pregnant women attending the antenatal care clinic, Rajavithi Hospital.

    PubMed

    Kovavisarach, Ekachai; Phromsila, Raweewan

    2012-08-01

    To determine the risk factors related to heartburn in pregnant women attending the antenatal care clinic, Rajavithi Hospital. Self-reporting questionnaire about demographic data and risk factors related to heartburn in those pregnant women between May 1 and July 31, 2010. Heartburn was found in 55 out of 452 pregnant women (12.2%). There were no significant differences in demographic characteristics and risk factors between the heartburn and non-heartburn groups. Consumption of alcoholic drinks was a reversely significant risk factor of heartburn (OR 0.11, CI 0.01 to 0.78) (p = 0.005). Heartburn was not uncommon, and no associated factors were demonstrated.

  18. New paradigms in PCOS: impaired glucose tolerance and cardiovascular risk. Clinical approach.

    PubMed

    Ravn, P

    2015-04-01

    Polycystic ovary syndrome (PCOS) is the most common endocrine disorder amongst women of reproductive age and is associated with various metabolic risk factors, in addition to chronic anovulation and factors related to androgen excess. Women with PCOS have a higher risk of insulin resistance, hyperinsulinemia, glucose intolerance, dyslipidemia, and an increased prothrombotic state, resulting in a higher risk of type 2 diabetes mellitus, subclinical atherosclerosis, vascular dysfunction, and apparently cardiovascular disease and mortality. The aim of the present article was to summarize current knowledge with focus on a suggestion to the clinical approach and handling of these metabolic risk factors.

  19. Using Clinical Risk Models for Lung Nodule Classification.

    PubMed

    Deppen, Stephen A; Grogan, Eric L

    2015-01-01

    Evaluation and diagnosis of indeterminate pulmonary nodules is a significant and increasing burden on our health care system. The advent of lung cancer screening with low-dose computed tomography only exacerbates this problem, and more surgeons will be evaluating smaller and screening discovered nodules. Multiple calculators exist that can help the clinician diagnose lung cancer at the bedside. The Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) model helps to determine who needs lung cancer screening, and the McWilliams and Mayo models help to guide the primary care clinician or pulmonologist with diagnosis by estimating the probability of cancer in patients with indeterminate pulmonary nodules. The Thoracic Research Evaluation And Treatment (TREAT) model assists surgeons to determine who needs a surgical biopsy among patients referred for suspicious lesions. Additional work is needed to develop decision support tools that will facilitate the use of these models in clinical practice, to complement the clinician's judgment and enhance shared decision making with the patient at the bedside.

  20. ARAC--The Montreal Jewish General Hospital Alzheimer Risk Assessment Clinic.

    PubMed

    Schipper, Hyman M; Liberman, Adrienne; Kelner, Nora; Babins, Lennie; Fried, Lynda; Bilbul, Melanie; Goodman, Rachel

    2011-07-01

    In parallel with robust efforts world-wide to develop effective neuroprotection for established disease, resources are being mobilized to delineate risk factors and implement preventive measures in a concerted effort to forestall the anticipated Alzheimer disease (AD) epidemic. A review of heritable and 'acquired' dementia risk factors, many operating at midlife, is presented in a companion paper. In 2009, an Alzheimer Risk Assessment Clinic (ARAC) was established at the Jewish General Hospital (Montreal) to address the concerns increasingly being voiced by active middle-aged individuals at risk for AD. A positive family history of AD and/or perceived changes in personal cognitive function (predominantly short-term memory) are main reasons for referral. The primary objectives of ARAC are to (i) ascertain, inform and mitigate the risks of developing AD in cognitively-healthy persons aged 40-65 based on best available medical and epidemiological evidence, (ii) conduct scientific research on midlife dementia risk and prevention in this population and (iii) provide instruction in dementia risk assessment and management to health professionals, clinical/research fellows, medical residents and students. ARAC infrastructure, evaluation protocol, risk profile classification scheme, interventions, knowledge dissemination program, case vignettes, and seminal research projects are described. It is hoped that ARAC and similar initiatives will help prevent or delay dementia by innovating effective interventions based on increasingly nuanced estimation of modifiable AD risk in presymptomatic persons.

  1. Integrating clinical trial findings into practice through risk stratification: the case of heart failure management.

    PubMed

    Smith, David H; Johnson, Eric S; Thorp, Micah L; Crispell, Kathy A; Yang, Xiuhai; Petrik, Amanda F

    2010-06-01

    Heart failure case management programs have been shown in clinical trials to be highly effective at preventing future hospitalizations. But the absolute benefits of these programs depend on the baseline risk of outcome in the treated population. Because baseline risks of hospitalization in trials are often higher than community-based samples, translating trial results to the community setting may be misleading. One solution is to identify subgroups for intervention that have sufficiently high baseline risk. Using estimates of hospitalizations averted from a previously published systematic review of heart failure management, we estimated a program's efficiency based on level of predicted risk. Medical history and demographic data on heart failure patients from a large integrated US health plan were used to build a logistic regression-based prognostic risk score for cardiovascular-related hospitalization over 1 year. We calculated the crude rate of hospitalizations for comparison with trial data. We also calculated the program's potential dollar savings from averting hospitalizations. The average risk of hospitalization in the systematic review's trials was 45%; our population's average observed risk was 18% and the risk among the highest risk patients was 33%. After accounting for the assumed annual intervention cost of $700, the base-case analysis (at $6000 per hospitalization) shows a savings of $122/patient at highest risk; failing to intervene according to predicted risk (no targeting) would actually cost $211/patient. Our findings illustrate how clinical trial findings can be efficiently integrated into community settings by using a prognostic risk score to focus attention on high-risk subgroups.

  2. Pulmonary embolism: investigation of the clinically assessed intermediate risk subgroup

    PubMed Central

    Warren, D J; Matthews, S

    2012-01-01

    Objectives The simplified Wells pre-test probability scoring algorithm for pre-investigation evaluation of pulmonary emboli (PE) is a commonly utilised and validated assessment tool. We sought to identify whether use of a dichotomised scoring system altered the overall negative predictive value (NPV) in patients referred for CT pulmonary angiography (CTPA) assessment of suspected PE. Methods Prospective data collection of all patients referred for CTPA evaluation of suspected acute PE during a 3 year period was carried out. Pre-test risk stratification was performed according to simplified Wells criteria in conjunction with plasma d-Dimer (Bio-Pool and IL test) estimation. Retrospective dichotomisation was also performed. Results 2531 patients were investigated for suspected acute PE; acute thromboemboli were confirmed in 22.7%. The overall NPV for negative d-Dimer and intermediate pre-test probability (PTP) was 98.9% [95% confidence interval (CI) 96.3–99.7%]; with retrospective dichotomisation, the NPV for the PE unlikely group was 99.0% (95% CI 94.8–99.8%). Implementation of dichotomised scoring, excluding PE unlikely with negative d-Dimer cases from further imaging, would have yielded a 4% reduction in CTPA referral pathway imaging at our institution. Conclusion We demonstrate no significant difference between exclusion in the intermediate subgroup and the retrospectively dichotomised PE unlikely group and demonstrate the high negative predictive power of the Bio-Pool and IL tests in conjunction with the Wells PTP tool. Prior to implementation of new guidelines for exclusion of patients with suspected PE from further imaging, hospitals should audit their own practice and validate the d-Dimer assay utilised at their institution. PMID:21937613

  3. Test of a clinical model of drinking and suicidal risk.

    PubMed

    Conner, Kenneth R; Gunzler, Douglas; Tang, Wan; Tu, Xin M; Maisto, Stephen A

    2011-01-01

    There are few data on the role of drinking patterns in suicidal thoughts or behavior among alcohol-dependent individuals (ADIs) and meager data on variables that may influence the role of drinking in suicidal thoughts and behavior. This study tested a heuristic model that predicts that drinking promotes suicidal thoughts and behavior, the association is mediated (accounted for) by depressive symptoms, and that anger moderates (increases) the risk associated with intense drinking. Data from Project MATCH, a multisite alcohol use disorders treatment trial, were analyzed using structural equation modeling. There were 1,726 participants including 24% women and a mean age of 40.2 ± 11.0 years. Subjects were assessed at baseline and at 3-, 9-, and 15-month follow-up. Two categorical measures (presence/absence) of suicidal ideation (SI) were used that were analyzed in separate models. Predictors of interest were continuous assessments of average drinking intensity (i.e., drinks per drinking day or DDD), drinking frequency (i.e., percent days abstinent or PDA), depression, and anger. Both DDD and PDA were associated with SI at a statistically significant level, with PDA showing an inverse association. Depression scores served as a partial mediator or a full mediator of the drinking-SI relationship depending on the measure of SI used in the analysis. The models testing anger scores as a moderator fit the data poorly and did not support that anger serves as a moderator of the drinking-SI association. Greater drinking intensity and drinking frequency predict SI among ADIs and depression serves as a mediator of these associations, but anger does not appear to serve as a moderator. Further research is required to clarify whether depression serves as a partial or full mediator and to see whether the results herein extend to suicidal behavior (i.e., suicide attempt, suicide). Copyright © 2010 by the Research Society on Alcoholism.

  4. Test of a Clinical Model of Drinking and Suicidal Risk

    PubMed Central

    Conner, Kenneth R.; Gunzler, Douglas; Tang, Wan; Tu, Xin M.; Maisto, Stephen A.

    2010-01-01

    Background There are few data on the role of drinking patterns in suicidal thoughts or behavior among alcohol dependent individuals (ADIs), and meager data on variables that may influence the role of drinking in suicidal thoughts and behavior. This study tested a heuristic model that predicts that drinking promotes suicidal thoughts and behavior, the association is mediated (accounted for) by depressive symptoms, and that anger moderates (increases) the risk associated with intense drinking. Methods Data from Project MATCH, a multi-site alcohol use disorders treatment trial, were analyzed using structural equation modeling. There were 1,726 participants including 24% women and a mean age of 40.2 ± 11.0 years. Subjects were assessed at baseline and at 3-, 9-, and 15-month follow-up. Two categorical measures (presence/absence) of suicidal ideation (SI) were used that were analyzed in separate models. Predictors of interest were continuous assessments of average drinking intensity (i.e., drinks per drinking day or DDD), drinking frequency (i.e., percent days abstinent or PDA), depression, and anger. Results Both DDD and PDA were associated with SI at a statistically significant level, with PDA showing an inverse association. Depression scores served as a partial mediator or a full mediator of the drinking – SI relationship depending on the measure of SI used in the analysis. The models testing anger scores as a moderator fit the data poorly and did not support that anger serves as a moderator of the drinking – SI association. Conclusions Greater drinking intensity and drinking frequency predict SI among ADIs and depression serves as a mediator of these associations but anger does not appear to serve as a moderator. Further research is required to clarify if depression serves as a partial- or full mediator and to see if the results herein extend to suicidal behavior (i.e., suicide attempt, suicide). PMID:20958331

  5. Health literacy and the perception of risk in a breast cancer family history clinic.

    PubMed

    Rutherford, E J; Kelly, J; Lehane, E A; Livingstone, V; Cotter, B; Butt, A; O'Sullivan, M J; O Connell, F; Redmond, H P; Corrigan, M A

    2016-11-28

    Informed consent is an essential component of medical practice, and especially so in procedural based specialties which entail varying degrees of risk. Breast cancer is one of the most common cancers in women, and as such is the focus of extensive research and significant media attention. Despite this, considerable misperception exists regarding the risk of developing breast cancer. This study aims to examine the accuracy of risk perception of women attending a breast cancer family history clinic, and to explore the relationship between risk perception accuracy and health literacy. A cross-sectional study of women attending a breast cancer family history clinic (n = 86) was carried out, consisting of a patient survey and a validated health literacy assessment. Patients' perception of personal and population breast cancer risk was compared to actual risk as calculated by a validated risk assessment tool. Significant discordance between real and perceived risks was observed. The majority (83.7%) of women overestimated their personal lifetime risk of developing breast cancer, as well as that of other women of the same age (89.5%). Health literacy was considered potentially inadequate in 37.2% of patients; there was a correlation between low health literacy and increased risk perception inaccuracy across both personal ten-year (rs = 0.224, p = 0.039) and general ten-year population estimations. (rs = 0.267, p = 0.013). Inaccuracy in risk perception is highly prevalent in women attending a breast cancer family history clinic. Health literacy inadequacy is significantly associated with this inaccuracy. Copyright © 2016 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

  6. Call for Standardized Definitions of Osteoarthritis and Risk Stratification for Clinical Trials and Clinical Use

    PubMed Central

    Kraus, Virginia Byers; Blanco, Francisco J.; Englund, Martin; Karsdal, Morten A.; Lohmander, L. Stefan

    2015-01-01

    Osteoarthritis is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for osteoarthritis (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 Osteoarthritis Development) and ROAP (Risk of Osteoarthritis 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

  7. International survey of awareness of genetic risk in the clinical sarcoma community.

    PubMed

    McBride, Kate A; Schlub, Timothy E; Ballinger, Mandy L; Thomas, David M; Tattersall, Martin Hn

    2016-06-01

    Integration of clinical genetics into oncology is variable. Sarcomas have a strong genetic component, with up to 1/30 patients carrying germline TP53 mutations. This study aimed to define genetic risk awareness among sarcoma physicians. Outcomes were attitudes toward genetic testing, level of cancer risk and awareness of risk reduction measures. An online survey was administered to members of the Connective Tissue Oncology Society and the Australasian Sarcoma Study Group. Sarcoma physicians (N = 124) from 21 countries participated, 40% of whom favored TP53 mutation testing in children regardless of family history, increasing to ∼83% for all age groups if a family history was present and ∼85% if multiple primary cancers were present. However, 33% were not aware that risk reduction strategies might identify some cancers at a more curable stage in carriers. Clinical genetics is not yet standard of care for multidisciplinary management of sarcoma. Awareness of genetic risk is important among sarcoma physicians. Attitudes among the sarcoma community were generally positive, but education on genetic risk in sarcoma patients and collaboration with clinical genetics services might improve quality of care. Sarcoma physicians need routine access to clinical genetics services so that potential germline TP53 mutation carriers are recognized. © 2016 John Wiley & Sons Australia, Ltd.

  8. Clinical decision support software for diabetic foot risk stratification: development and formative evaluation.

    PubMed

    Schoen, Deborah E; Glance, David G; Thompson, Sandra C

    2015-01-01

    Identifying people at risk of developing diabetic foot complications is a vital step in prevention programs in primary healthcare settings. Diabetic foot risk stratification systems predict foot ulceration. The aim of this study was to explore the views and experiences of potential end users during development and formative evaluations of an electronic diabetic foot risk stratification tool based on evidence-based guidelines and determine the accuracy of the tool. Formative evaluation of the risk tool occurred in five stages over an eight-month period and employed a mixed methods research design consisting of semi-structured interviews, focus group and participant observation, online survey, expert review, comparison to the Australian Guidelines and clinical testing. A total of 43 healthcare practitioners trialled the computerised clinical decision support system during development, with multiple software changes made as a result of feedback. Individual and focus group participants exposed critical design flaws. Live testing revealed risk stratification errors and functional limitations providing the basis for practical improvements. In the final product, all risk calculations and recommendations made by the clinical decision support system reflect current Australian Guidelines. Development of the computerised clinical decision support system using evidence-based guidelines can be optimised by a multidisciplinary iterative process of feedback, testing and software adaptation by experts in modern development technologies.

  9. Prevalence and risk factors for hepatitis B virus infections among visitors to an STD clinic.

    PubMed Central

    van Duynhoven, Y T; van de Laar, M J; Schop, W A; Rothbarth, P H; van der Meijden, W I; van Loon, A M; Sprenger, M J

    1997-01-01

    OBJECTIVE: To determine the prevalence and risk factors for hepatitis B virus (HBV) infections among individuals attending an STD clinic in a low endemic region. STUDY DESIGN: A total of 1228 women and 1648 men attending the STD clinic at the University Hospital Rotterdam, Netherlands, were examined for HBV infection by determination of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B core antigen (anti-HBc). Demographic characteristics, information on sexual behaviour, and intravenous drug use were recorded. RESULTS: The seroprevalence of HBsAg was 1.4% in women and 2.1% in men (0% in homosexual men). The seroprevalence of anti-HBc was 13% in women and 20% in men (36% in homosexual men). Native country, intravenous drug use, a history of STD, and the number of partners in the past half year (inversely) were independent risk factors for HBsAg positivity in women and heterosexual men. For anti-HBc independent associations were observed for native country, age, intravenous drug use, commercial sex, number of lifetime partners, homosexual contacts, orogenital contact (inverse), and a history of STD. CONCLUSION: The HBV prevalence in the STD clinic attendants was high, exceeding the national estimate, and indicates that the STD clinic population may be considered a high risk group. Our data confirmed an increased risk for HBV infections among established risk groups. Therefore, these risk groups should be routinely screened to identify HBV cases for counselling and contact tracing. PMID:9582467

  10. The fear factor of risk - clinical governance and midwifery talk and practice in the UK.

    PubMed

    Scamell, Mandie

    2016-07-01

    Through the critical application of social theory, this paper will scrutinise how the operations of risk management help to constitute midwives׳ understandings of childbirth in a particular way. Drawing from rich ethnographic data, collected in the southeast of England, the paper presents empirical evidence to critically explore how institutional concerns around risk and risk management impact upon the way midwives can legitimately imagine and manage labour and childbirth. Observational field notes, transcribed interviews with various midwives, along with material culture in the form of documentary evidence will be used to explore the unintended consequences of clinical governance and its risk management technologies. Through this analysis the fear factor of risk in midwifery talk and practice will be introduced to provide an insight into how risk management impacts midwifery practice in the UK. Copyright © 2016. Published by Elsevier Ltd.

  11. 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.

  12. Genetic Risk, Coronary Heart Disease Events, and the Clinical Benefit of Statin Therapy

    PubMed Central

    Smith, JG; Chasman, DI; Caulfield, M; Devlin, JJ; Nordio, F; Hyde, C; Cannon, CP; Sacks, F; Poulter, N; Sever, P; Ridker, PM; Braunwald, E; Melander, O

    2015-01-01

    Background Genetic variants have been associated with the risk of coronary heart disease (CHD). We tested whether a composite of these variants could identify the risk of both incident as well as recurrent CHD events and distinguish individuals who derived greater clinical benefit from statin therapy. Methods A community-based cohort and four randomized controlled trials of both primary (JUPITER and ASCOT) and secondary (CARE and PROVE IT-TIMI 22) prevention with statin therapy totaling 48,421 individuals and 3,477 events were included in these analyses. We examined the association of a genetic risk score based on 27 genetic variants with incident or recurrent CHD, adjusting for established clinical predictors. We then investigated the relative and absolute risk reductions in CHD events with statin therapy stratified by genetic risk. Data from studies were combined using meta-analysis. Findings When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient of risk for incident or recurrent CHD was demonstrated with the multivariable-adjusted HRs (95% CI) for CHD for the intermediate and high genetic risk categories vs. low genetic risk category being 1.32 (1.20-1.46, P<0.0001) and 1.71 (1.54-1.91, P<0.0001), respectively. In terms of the benefit of statin therapy in the four randomized trials, there was a significant gradient of increasing relative risk reduction across the low, intermediate, and high genetic risk categories (13%, 29%, and 48%, P=0.0277). Similarly, greater absolute risk reductions were seen in those individuals in higher genetic risk categories (P=0.0101), resulting in an approximate three-fold gradient in the number needed to treat (NNT) in the primary prevention trials. Specifically, in the primary prevention trials, the NNT to prevent one MACE over 10 years for the low, intermediate, and high GRS individuals was 66, 42, and 25 in JUPITER and 57, 47, and 20

  13. Actuarial assessment of violence risk in hospital-based partner assault clinics.

    PubMed

    Hilton, N Zoe; Harris, Grant T; Holder, Norah

    2008-12-01

    Hospital-based partner assault clinics are a relatively recent addition to the community response to partner violence. In this study, 66% of 111 women attending hospital clinics for partner assault were physically injured and 43% reported death threats. Few concurrently used other services (shelters or police) and most relied on female friends and relatives for help. Many participants who currently lived with the perpetrator were contemplating leaving but only a third had made plans to do so. Participants faced an unusually high risk of future assault, according to both victim interview using the ODARA actuarial risk assessment and their own perceptions. Findings imply an important role for partner assault clinics and the feasibility of the victim service sector's using the same actuarial risk assessments as the criminal justice system.

  14. Report of a workshop on malignant lymphoma: a review of molecular and clinical risk profiling.

    PubMed

    Gleissner, B; Küppers, R; Siebert, R; Glass, B; Trümper, L; Hiddemann, W; Dreyling, M

    2008-06-01

    Molecular genetic analysis adds important information for lymphoma biology and classification, but the latter is challenged by recent improvement of combined chemo-immunotherapy. In aggressive lymphoma, molecular profiling identifies risk groups with certain genetic background but still the International Prognostic Index (IPI) remains the most important clinically applicable predictor of outcome. In follicular lymphoma (FL), the importance of the meshwork of bystander cells becomes increasingly evident. As combined immuno-chemotherapy improved the prognosis of the patients, several clinical trials indicated that the FLIPI still efficiently discriminates patients at risk for transformation and relapse, although several mechanisms of transformation seem to exist. In mantle cell lymphoma it has been proven that pathogenesis and prognosis mainly depend on deregulation of the cell cycle. A reliable clinical risk score could be established.

  15. Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism.

    PubMed

    Spielman, Bethany

    2015-03-01

    This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

  16. Impact of clinical inertia on cardiovascular risk factors in patients with diabetes.

    PubMed

    Whitford, David L; Al-Anjawi, Hussam A; Al-Baharna, Marwa M

    2014-07-01

    To determine whether clinical inertia is associated with simpler interventions occurring more often than complex changes and the association between clinical inertia and outcomes. Prevalence of clinical inertia over a 30 month period for hyperglycaemia, hypertension and dyslipidaemia was calculated in a random sample (n=334) of patients attending a diabetes clinic. Comparisons between prevalence of clinical inertia and outcomes for each condition were examined using parametric tests of association. There was less clinical inertia in hyperglycaemia (29% of consultations) compared with LDL (80% of consultations) and systolic BP (68% of consultations). Consultations where therapy was intensified had a greater reduction in risk factor levels than when no change was made. No association was found between treatment intensity scores and changes in HbA1c, LDL or blood pressure over 30 months. Physicians are no more likely to intervene in conditions where simple therapeutic changes are necessary as opposed to complex changes. Greater clinical inertia leads to poorer outcomes. There continues to be substantial clinical inertia in routine clinical practice. Physicians should adopt a holistic approach to cardiovascular risk reduction in patients with diabetes, adhere more closely to established management guidelines and emphasize personal individualized target setting. Copyright © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  17. What patient characteristics guide nurses' clinical judgement on pressure ulcer risk? A mixed methods study.

    PubMed

    Balzer, K; Kremer, L; Junghans, A; Halfens, R J G; Dassen, T; Kottner, J

    2014-05-01

    Nurses' clinical judgement plays a vital role in pressure ulcer risk assessment, but evidence is lacking which patient characteristics are important for nurses' perception of patients' risk exposure. To explore which patient characteristics nurses employ when assessing pressure ulcer risk without use of a risk assessment scale. Mixed methods design triangulating observational data from the control group of a quasi-experimental trial and data from semi-structured interviews with nurses. Two traumatological wards at a university hospital. Quantitative data: A consecutive sample of 106 patients matching the eligibility criteria (age ≥ 18 years, no pressure ulcers category ≥ 2 at admission and ≥ 5 days expected length of stay). Qualitative data: A purposive sample of 16 nurses. Quantitative data: Predictor variables for pressure ulcer risk were measured by study assistants at the bedside each second day. Concurrently, nurses documented their clinical judgement on patients' pressure ulcer risk by means of a 4-step global judgement scale. Bivariate correlations between predictor variables and nurses' risk estimates were established. Qualitative data: In interviews, nurses were asked to assess fictitious patients' pressure ulcer risk and to justify their risk estimates. Patient characteristics perceived as relevant for nurses' judements were thematically clustered. Triangulation: Firstly, predictors of nurses' risk estimates identified in bivariate analysis were cross-mapped with interview findings. Secondly, three models to predict nurses' risk estimates underwent multiple linear regression analysis. Nurses consider multiple patient characteristics for pressure ulcer risk assessment, but regard some conditions more important than others. Triangulation showed that these are measures reflecting patients' exposure to pressure or overall care dependency. Qualitative data furthermore indicate that nurses are likely to trade off risk-enhancing conditions against

  18. Effect of clinical and social risk factors on hospital profiling for stroke readmission: a cohort study.

    PubMed

    Keyhani, Salomeh; Myers, Laura J; Cheng, Eric; Hebert, Paul; Williams, Linda S; Bravata, Dawn M

    2014-12-02

    The Centers for Medicare & Medicaid Services (CMS) and Veterans Health Administration (VA) will report 30-day stroke readmission rates as a measure of hospital quality. A national debate on whether social risk factors should be included in models developed for hospital profiling is ongoing. To compare a CMS-based model of 30-day readmission with a more comprehensive model that includes measures of social risk (such as homelessness) or clinical factors (such as stroke severity and functional status). Data from a retrospective cohort study were used to develop a CMS-based 30-day readmission model that included age and comorbid conditions based on codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (model 1). This model was then compared with one that included administrative social risk factors (model 2). Finally, the CMS model (model 1) was compared with a model that included social risk and clinical factors from chart review (model 3). These 3 models were used to rank hospitals by 30-day risk-standardized readmission rates and examine facility rankings among the models. Hospitals in the VA. Patients hospitalized with stroke in 2007. 30-day readmission rates. The 30-day readmission rate was 12.8%. The c-statistics for the 3 models were 0.636, 0.646, and 0.661, respectively. All hospitals were classified as performing "as expected" using all 3 models (that is, performance did not differ from the VA national average); therefore, the addition of detailed clinical information or social risk factors did not alter assessment of facility performance. A predominantly male veteran cohort limits the generalizability of these findings. In the VA, more comprehensive models that included social risk and clinical factors did not affect hospital comparisons based on 30-day readmission rates. U.S. Department of Veterans Affairs.

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

    PubMed Central

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

    2016-01-01

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

  20. 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.

  1. A stillbirth calculator: Development and internal validation of a clinical prediction model to quantify stillbirth risk.

    PubMed

    Trudell, Amanda S; Tuuli, Methodius G; Colditz, Graham A; Macones, George A; Odibo, Anthony O

    2017-01-01

    To generate a clinical prediction tool for stillbirth that combines maternal risk factors to provide an evidence based approach for the identification of women who will benefit most from antenatal testing for stillbirth prevention. Retrospective cohort study. Midwestern United States quaternary referral center. Singleton pregnancies undergoing second trimester anatomic survey from 1999-2009. Pregnancies with incomplete follow-up were excluded. Candidate predictors were identified from the literature and univariate analysis. Backward stepwise logistic regression with statistical comparison of model discrimination, calibration and clinical performance was used to generate final models for the prediction of stillbirth. Internal validation was performed using bootstrapping with 1,000 repetitions. A stillbirth risk calculator and stillbirth risk score were developed for the prediction of stillbirth at or beyond 32 weeks excluding fetal anomalies and aneuploidy. Statistical and clinical cut-points were identified and the tools compared using the Integrated Discrimination Improvement. Antepartum stillbirth. 64,173 women met inclusion criteria. The final stillbirth risk calculator and score included maternal age, black race, nulliparity, body mass index, smoking, chronic hypertension and pre-gestational diabetes. The stillbirth calculator and simple risk score demonstrated modest discrimination but clinically significant performance with no difference in overall performance between the tools [(AUC 0.66 95% CI 0.60-0.72) and (AUC 0.64 95% CI 0.58-0.70), (p = 0.25)]. A stillbirth risk score was developed incorporating maternal risk factors easily ascertained during prenatal care to determine an individual woman's risk for stillbirth and provide an evidenced based approach to the initiation of antenatal testing for the prediction and prevention of stillbirth.

  2. A stillbirth calculator: Development and internal validation of a clinical prediction model to quantify stillbirth risk

    PubMed Central

    Tuuli, Methodius G.; Colditz, Graham A.; Macones, George A.; Odibo, Anthony O.

    2017-01-01

    Objective To generate a clinical prediction tool for stillbirth that combines maternal risk factors to provide an evidence based approach for the identification of women who will benefit most from antenatal testing for stillbirth prevention. Design Retrospective cohort study Setting Midwestern United States quaternary referral center Population Singleton pregnancies undergoing second trimester anatomic survey from 1999–2009. Pregnancies with incomplete follow-up were excluded. Methods Candidate predictors were identified from the literature and univariate analysis. Backward stepwise logistic regression with statistical comparison of model discrimination, calibration and clinical performance was used to generate final models for the prediction of stillbirth. Internal validation was performed using bootstrapping with 1,000 repetitions. A stillbirth risk calculator and stillbirth risk score were developed for the prediction of stillbirth at or beyond 32 weeks excluding fetal anomalies and aneuploidy. Statistical and clinical cut-points were identified and the tools compared using the Integrated Discrimination Improvement. Main outcome measures Antepartum stillbirth Results 64,173 women met inclusion criteria. The final stillbirth risk calculator and score included maternal age, black race, nulliparity, body mass index, smoking, chronic hypertension and pre-gestational diabetes. The stillbirth calculator and simple risk score demonstrated modest discrimination but clinically significant performance with no difference in overall performance between the tools [(AUC 0.66 95% CI 0.60–0.72) and (AUC 0.64 95% CI 0.58–0.70), (p = 0.25)]. Conclusion A stillbirth risk score was developed incorporating maternal risk factors easily ascertained during prenatal care to determine an individual woman’s risk for stillbirth and provide an evidenced based approach to the initiation of antenatal testing for the prediction and prevention of stillbirth. PMID:28267756

  3. 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.

  4. Risk communication in clinical trials: a cognitive experiment and a survey.

    PubMed

    Cheung, Yin Bun; Wee, Hwee Lin; Thumboo, Julian; Goh, Cynthia; Pietrobon, Ricardo; Toh, Han Chong; Yong, Yu Fen; Tan, Say Beng

    2010-09-27

    A Royal Statistical Society Working Party recently recommended that "Greater use should be made of numerical, as opposed to verbal, descriptions of risk" in first-in-man clinical trials. This echoed the view of many clinicians and psychologists about risk communication. As the clinical trial industry expands rapidly across the globe, it is important to understand risk communication in Asian countries. We conducted a cognitive experiment about participation in a hypothetical clinical trial of a pain relief medication and a survey in cancer and arthritis patients in Singapore. In part 1 of the experiment, the patients received information about the risk of side effects in one of three formats (frequency, percentage and verbal descriptor) and in one of two sequences (from least to most severe and from most to least severe), and were asked about their willingness to participate. In part 2, the patients received information about the risk in all three formats, in the same sequence, and were again asked about their willingness to participate. A survey of preference for risk presentation methods and usage of verbal descriptors immediately followed. Willingness to participate and the likelihood of changing one's decision were not affected by the risk presentation methods. Most patients indicated a preference for the frequency format, but patients with primary school or no formal education were indifferent. While the patients used the verbal descriptors "very common", "common" and "very rare" in ways similar to the European Commission's Guidelines, their usage of the descriptors "uncommon" and "rare" was substantially different from the EU's. In this sample of Asian cancer and arthritis patients, risk presentation format had no impact on willingness to participate in a clinical trial. However, there is a clear preference for the frequency format. The lay use of verbal descriptors was substantially different from the EU's.

  5. 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

  6. Risk communication in clinical trials: A cognitive experiment and a survey

    PubMed Central

    2010-01-01

    Background A Royal Statistical Society Working Party recently recommended that "Greater use should be made of numerical, as opposed to verbal, descriptions of risk" in first-in-man clinical trials. This echoed the view of many clinicians and psychologists about risk communication. As the clinical trial industry expands rapidly across the globe, it is important to understand risk communication in Asian countries. Methods We conducted a cognitive experiment about participation in a hypothetical clinical trial of a pain relief medication and a survey in cancer and arthritis patients in Singapore. In part 1 of the experiment, the patients received information about the risk of side effects in one of three formats (frequency, percentage and verbal descriptor) and in one of two sequences (from least to most severe and from most to least severe), and were asked about their willingness to participate. In part 2, the patients received information about the risk in all three formats, in the same sequence, and were again asked about their willingness to participate. A survey of preference for risk presentation methods and usage of verbal descriptors immediately followed. Results Willingness to participate and the likelihood of changing one's decision were not affected by the risk presentation methods. Most patients indicated a preference for the frequency format, but patients with primary school or no formal education were indifferent. While the patients used the verbal descriptors "very common", "common" and "very rare" in ways similar to the European Commission's Guidelines, their usage of the descriptors "uncommon" and "rare" was substantially different from the EU's. Conclusion In this sample of Asian cancer and arthritis patients, risk presentation format had no impact on willingness to participate in a clinical trial. However, there is a clear preference for the frequency format. The lay use of verbal descriptors was substantially different from the EU's. PMID:20868525

  7. Clinical pathways as instruments for risk and cost management in hospitals - a discussion paper.

    PubMed

    Romeyke, Tobias; Stummer, Harald

    2012-02-29

    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. 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. 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. 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 provision of services.

  8. Nursing Diagnosis Risk for falls: prevalence and clinical profile of hospitalized patients.

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  10. Clinical Risk Assessment in the Antiphospholipid Syndrome: Current Landscape and Emerging Biomarkers.

    PubMed

    Chaturvedi, Shruti; McCrae, Keith R

    2017-07-01

    Laboratory criteria for the classification of antiphospholipid syndrome include the detection of a lupus anticoagulant and/or anticardiolipin and anti-β2-glycoprotein I antibodies. However, the majority of patients who test positive in these assays do not have thrombosis. Current risk-stratification tools are largely limited to the antiphospholipid antibody profile and traditional thrombotic risk factors. Novel biomarkers that correlate with disease activity and potentially provide insight into future clinical events include domain 1 specific anti-β2GPI antibodies, antibodies to other phospholipids or phospholipid/protein antigens (such as anti-PS/PT), and functional/biological assays such as thrombin generation, complement activation, levels of circulating microparticles, and annexin A5 resistance. Clinical risk scores may also have value in predicting clinical events. Biomarkers that predict thrombosis risk in patients with antiphospholipid antibodies have been long sought, and several biomarkers have been proposed. Ultimately, integration of biomarkers with established assays and clinical characteristics may offer the best chance of identifying patients at highest risk of APS-related complications.

  11. 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

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

    PubMed Central

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

    2003-01-01

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

  13. Clinical factors predicting bacteremia in low-risk febrile neutropenia after anti-cancer chemotherapy.

    PubMed

    Ha, Young Eun; Song, Jae-Hoon; Kang, Won Ki; Peck, Kyong Ran; Chung, Doo Ryeon; Kang, Cheol-In; Joung, Mi-Kyong; Joo, Eun-Jeong; Shon, Kyung Mok

    2011-11-01

    Bacteremia is an important clinical condition in febrile neutropenia that can cause clinical failure of antimicrobial therapy. The purpose of this study was to investigate the clinical factors predictive of bacteremia in low-risk febrile neutropenia at initial patient evaluation. We performed a retrospective cohort study in a university hospital in Seoul, Korea, between May 1995 and May 2007. Patients who met the criteria of low-risk febrile neutropenia at the time of visit to emergency department after anti-cancer chemotherapy were included in the analysis. During the study period, 102 episodes of bacteremia were documented among the 993 episodes of low-risk febrile neutropenia. Single gram-negative bacteremia was most frequent. In multivariate regression analysis, initial body temperature ≥39°C, initial hypotension, presence of clinical sites of infection, presence of central venous catheter, initial absolute neutrophil count <50/mm(3), and the CRP ≥10 mg/dL were statistically significant predictors for bacteremia. A scoring system using these variables was derived and the likelihood of bacteremia was well correlated with the score points with AUC under ROC curve of 0.785. Patients with low score points had low rate of bacteremia, thus, would be candidates for outpatient-based or oral antibiotic therapy. We identified major clinical factors that can predict bacteremia in low-risk febrile neutropenia.

  14. Audio computer assisted interviewing to measure HIV risk behaviours in a clinic population.

    PubMed

    Rogers, S M; Willis, G; Al-Tayyib, A; Villarroel, M A; Turner, C F; Ganapathi, L; Zenilman, J; Jadack, R

    2005-12-01

    To examine whether audio computer assisted survey interviewing (ACASI) influenced responses to sensitive HIV risk behaviour questions, relative to interviewer administration of those questions (IAQ), among patients attending a sexually transmitted infection (STI) clinic and whether the impact of interview mode on reporting of risk behaviours was homogeneous across subgroups of patients (defined by age, sex, and previous STI clinic experience). 1350 clinic patients were assigned to complete a detailed behavioural survey on sexual risk practices, previous STIs and symptoms, condom use, and drug and alcohol use using either ACASI or IAQ. Respondents assigned to ACASI were more likely to report recent risk behaviours such as sex without a condom in the past 24 hours (adjusted OR = 1.9), anal sex (adjusted OR = 2.0), and one or more new partners in the past 6 months (adjusted OR = 1.5) compared to those interviewed by IAQ. The impact of ACASI varied by sex but, contrary to expectations, not by whether the patient had previously visited an STI clinic. Mode of survey administration made little difference within this population in reports of STI knowledge, previous STIs, STI symptoms, or illicit drug use. ACASI provides a useful tool for improving the quality of behavioural data in clinical environments.

  15. 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.

  16. The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications.

    PubMed

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2014-10-01

    To assess the proportion of clinical trials explicitly reporting the risk of unblinding, to evaluate the completeness of reporting on unblinding risk, and to describe the reported procedures involved in assessing unblinding. We sampled at random 300 blinded randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8%), reported compromised blinding; and 8 publications, or 3% (95% CI, 1, 5%), intact blinding. The reporting on risk of unblinding in the 24 trial publications was generally incomplete. The median proportion of assessments per trial affected by unblinding was 3% (range 1-30%). The most common mechanism for unblinding was perceptible physical properties of the treatments, for example, a difference in the taste and odor of a typhoid vaccine compared with its placebo. Published articles on randomized clinical trials infrequently reported risk of unblinding. This may reflect a tendency for avoiding reporting actual or suspected unblinding or a genuine low risk of unblinding. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Risk indicator taxonomy for supervision of clinical trials on medicinal products.

    PubMed

    Jongen, Peter M J M; van den Bogert, Cornelis A; van de Laar, Catharina W E; Notenboom, Kim; Hille, Elysée T M; Hegger, Ingrid

    2016-07-01

    To facilitate a risk-based approach for the supervision of clinical trials on medicinal products, we identified and categorized indicators that may present an elevated safety and/or ethical risk for participants, and/or for data integrity. The indicators are relevant for all stakeholders including participants, regulatory bodies, health care inspectorates, sponsors and trial sites. The sources of indicators included Medline (using the search terms risk-based/-triggered/-driven oversight/monitoring/inspection), relevant documents from websites of regulatory authorities in Europe, North America and Australia, and results of a brainstorm session organized for experts working in the field. Indicators were classified according to risk area (safety and ethical, data integrity, or both). In total, we identified 69 risk indicators that were categorized into six branch-levels of the taxonomy. We visualized the taxonomy in a tree structure to clearly distinguish individual indicators. In addition to readily detectable risk indicators, more context-related aspects determine the final impact of the trial and constitute further components in risk assessment. Context-related aspects include potential high media attention, consequences for the reputation of medical research, and the socioeconomic situation in the geographic region and have to be considered on a case-by-case basis. We identified a wide array of risk indicators for clinical trials on medicinal products and we used a tree structure to incorporate the indicators identified to clearly distinguish individual indicators and to enable efficient use of the indicators. The overview of indicators may facilitate multiple stakeholders in developing structured risk assessment (identification and analysis) for supervising clinical trials on medicinal products. Stakeholders can interpret and prioritize the indicators from their own perspective.

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

    PubMed

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

    2016-09-08

    Chronic myelomonocytic leukemia (CMML) is a myelodysplastic/myeloproliferative neoplasm with variable clinical course. To predict the clinical outcome, we previously developed a CMML-specific prognostic scoring system (CPSS) based on clinical parameters and cytogenetics. In this work, we tested the hypothesis that accounting for gene mutations would further improve risk stratification of CMML patients. We therefore sequenced 38 genes to explore the role of somatic mutations in disease phenotype and clinical outcome. Overall, 199 of 214 (93%) CMML patients carried at least 1 somatic mutation. Stepwise linear regression models showed that these mutations accounted for 15% to 24% of variability of clinical phenotype. Based on multivariable Cox regression analyses, cytogenetic abnormalities and mutations in RUNX1, NRAS, SETBP1, and ASXL1 were independently associated with overall survival (OS). Using these parameters, we defined a genetic score that identified 4 categories with significantly different OS and cumulative incidence of leukemic evolution. In multivariable analyses, genetic score, red blood cell transfusion dependency, white blood cell count, and marrow blasts retained independent prognostic value. These parameters were included into a clinical/molecular CPSS (CPSS-Mol) model that identified 4 risk groups with markedly different median OS (from >144 to 18 months, hazard ratio [HR] = 2.69) and cumulative incidence of leukemic evolution (from 0% to 48% at 4 years, HR = 3.84) (P < .001). The CPSS-Mol fully retained its ability to risk stratify in an independent validation cohort of 260 CMML patients. In conclusion, integrating conventional parameters and gene mutations significantly improves risk stratification of CMML patients, providing a robust basis for clinical decision-making and a reliable tool for clinical trials. © 2016 by The American Society of Hematology.

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

    PubMed Central

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

    2016-01-01

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

  20. Optimized outcome prediction in breast cancer by combining the 70-gene signature with clinical risk prediction algorithms.

    PubMed

    Drukker, C A; Nijenhuis, M V; Bueno-de-Mesquita, J M; Retèl, V P; van Harten, W H; van Tinteren, H; Wesseling, J; Schmidt, M K; Van't Veer, L J; Sonke, G S; Rutgers, E J T; van de Vijver, M J; Linn, S C

    2014-06-01

    Clinical guidelines for breast cancer treatment differ in their selection of patients at a high risk of recurrence who are eligible to receive adjuvant systemic treatment (AST). The 70-gene signature is a molecular tool to better guide AST decisions. The aim of this study was to evaluate whether adding the 70-gene signature to clinical risk prediction algorithms can optimize outcome prediction and consequently treatment decisions in early stage, node-negative breast cancer patients. A 70-gene signature was available for 427 patients participating in the RASTER study (cT1-3N0M0). Median follow-up was 61.6 months. Based on 5-year distant-recurrence free interval (DRFI) probabilities survival areas under the curve (AUC) were calculated and compared for risk estimations based on the six clinical risk prediction algorithms: Adjuvant! Online (AOL), Nottingham Prognostic Index (NPI), St. Gallen (2003), the Dutch National guidelines (CBO 2004 and NABON 2012), and PREDICT plus. Also, survival AUC were calculated after adding the 70-gene signature to these clinical risk estimations. Systemically untreated patients with a high clinical risk estimation but a low risk 70-gene signature had an excellent 5-year DRFI varying between 97.1 and 100 %, depending on the clinical risk prediction algorithms used in the comparison. The best risk estimation was obtained in this cohort by adding the 70-gene signature to CBO 2012 (AUC: 0.644) and PREDICT (AUC: 0.662). Clinical risk estimations by all clinical algorithms improved by adding the 70-gene signature. Patients with a low risk 70-gene signature have an excellent survival, independent of their clinical risk estimation. Adding the 70-gene signature to clinical risk prediction algorithms improves risk estimations and therefore might improve the identification of early stage node-negative breast cancer patients for whom AST has limited value. In this cohort, the PREDICT plus tool in combination with the 70-gene signature provided the

  1. Is Clinical Stage T2C Prostate Cancer Intermediate or High-Risk Disease?

    PubMed Central

    Klaassen, Zachary; Singh, Abhay A.; Howard, Lauren E.; Feng, Zhaoyong; Trock, Bruce; Terris, Martha K.; Aronson, William J.; Cooperberg, Matthew R.; Amling, Christopher L.; Kane, Christopher J.; Partin, Alan; Han, Misop; Freedland, Stephen J.

    2014-01-01

    Background Clinical stage T2c (cT2c) is an indeterminate factor in prostate cancer (PC) risk stratification. In D’Amico grouping and AUA guidelines, cT2c is high-risk, whereas NCCN and EAU classify cT2c as intermediate-risk. We assessed whether cT2c tumors, without other high-risk factors (cT2c not otherwise specified (cT2c-nos)), behave as intermediate or high-risk by analyzing biochemical recurrence (BCR) after radical prostatectomy. Methods We analyzed 2,759 men from SEARCH and 12,900 men from Johns Hopkins Hospital (JHH) from 1988–2011 and 1982–2012, respectively. Patients were grouped into low (PSA<10ng/mL, Gleason sum≤6, and cT1-T2a), intermediate (PSA 10–20ng/mL, Gleason sum 7, or cT2b) and high-risk PC (PSA>20ng/mL, Gleason sum 8–10, or cT3). Men with cT2c who were not otherwise high-risk (i.e. PSA<20 ng/mL and Gleason sum<8) were placed into a separate category termed cT2c -nos. Associations between cT2c-nos and intermediate-risk, and high-risk patients and BCR were tested using log-rank test and Cox proportional analyses models. Results 99 men (4%) from SEARCH and 202 (2%) from JHH were cT2c-nos. cT2c-nos patients had similar BCR risk as intermediate-risk (SEARCH p=0.27; JHH p=0.23), but significantly lower BCR vs. high-risk (SEARCH p<0.001; JHH p<0.001). When specifically compared to intermediate and high-risk patients, and after adjusting for year and center, cT2c-nos patients had outcomes comparable to intermediate-risk (SEARCH p=0.53; JHH p=0.54), but significantly better than high-risk patients (SEARCH p=0.003; JHH p<0.001). Conclusions Patients with cT2c without other high-risk features had similar outcomes as intermediate-risk and significantly better than high-risk PC. These findings suggest men with cT2c should be considered intermediate-risk. PMID:25492369

  2. [Abstract bodies, concrete risks: clinical devices and the health of ova donors in Argentine reproductive medicine].

    PubMed

    Ariza, Lucía

    2016-01-01

    Using a methodological perspective grounded in science and technology studies, this article analyzes two sociotechnical devices used in Argentine reproductive medicine (biostatistical measures and donation registries) with the aim of controlling both the so-called "genetic risk" arising from the use of donated ova as well as the health risks to female donors. By examining how the deployment of monitoring criteria disregards the specificity of ova donation, the article suggests that it is not the absence of control measures and clinical criteria that produces an inadequate monitoring of such risks, but rather the concrete ways in which such measures are implemented that results in potential harms to the health of female donors.

  3. Evaluation of digital dermoscopy in a pigmented lesion clinic: clinician versus computer assessment of malignancy risk.

    PubMed

    Boldrick, Jennifer C; Layton, Christle J; Nguyen, Josephine; Swetter, Susan M

    2007-03-01

    Digital dermoscopy systems employ computer-based algorithms to quantitate features of pigmented skin lesions (PSLs) and provide an assessment of malignancy risk. We evaluated interobserver concordance of PSL malignancy risk between a pigmented lesion specialist and an artificial neural network (ANN)-based automated digital dermoscopy system. While digital dermoscopy provides a reliable means of image capture, storage, and comparison of PSLs over time, the ANN algorithm requires further training and validation before the malignancy risk assessment feature can be widely used in clinical practice.

  4. Fracture risk prediction using BMD and clinical risk factors in early postmenopausal women: sensitivity of the WHO FRAX tool.

    PubMed

    Trémollieres, Florence A; Pouillès, Jean-Michel; Drewniak, Nicolas; Laparra, Jacques; Ribot, Claude A; Dargent-Molina, Patricia

    2010-05-01

    The aim of this prospective study was (1) to identify significant and independent clinical risk factors (CRFs) for major osteoporotic (OP) fracture among peri- and early postmenopausal women, (2) to assess, in this population, the discriminatory capacity of FRAX and bone mineral density (BMD) for the identification of women at high risk of fracture, and (3) to assess whether adding risk factors to either FRAX or BMD would improve discriminatory capacity. The study population included 2651 peri- and early postmenopausal women [mean age (+/- SD): 54 +/- 4 years] with a mean follow-up period of 13.4 years (+/-1.4 years). At baseline, a large set of CRFs was recorded, and vertebral BMD was measured (Lunar, DPX) in all women. Femoral neck BMD also was measured in 1399 women in addition to spine BMD. Women with current or past OP treatment for more than 3 months at baseline (n = 454) were excluded from the analyses. Over the follow-up period, 415 women sustained a first low-energy fracture, including 145 major OP fractures (108 wrist, 44 spine, 20 proximal humerus, and 13 hip). In Cox multivariate regression models, only 3 CRFs were significant predictors of a major OP fracture independent of BMD and age: a personal history of fracture, three or more pregnancies, and current postmenopausal hormone therapy. In the subsample of women who had a hip BMD measurement and who were not receiving OP therapy (including hormone-replacement therapy) at baseline, mean FRAX value was 3.8% (+/-2.4%). The overall discriminative value for fracture, as measured by the area under the Receiver Operating Characteristic (ROC) curve (AUC), was equal to 0.63 [95% confidence interval (CI) 0.56-0.69] and 0.66 (95% CI 0.60-0.73), respectively, for FRAX and hip BMD. Sensitivity of both tools was low (ie, around 50% for 30% of the women classified as the highest risk). Adding parity to the predictive model including FRAX or using a simple risk score based on the best predictive model in our

  5. Prevalence and clinical relevance of interview-assessed psychosis-risk symptoms in the young adult community.

    PubMed

    Schultze-Lutter, Frauke; Michel, Chantal; Ruhrmann, Stephan; Schimmelmann, Benno G

    2017-09-11

    An efficient indicated prevention of psychotic disorders requires valid risk criteria that work in both clinical and community samples. Yet, ultra-high risk and basic symptom criteria were recently recommended for use in clinical samples only. Their use in the community was discouraged for lack of knowledge about their prevalence, clinical relevance and risk factors in non-clinical, community settings when validly assessed with the same instruments used in the clinic. Using semi-structured telephone interviews with established psychosis-risk instruments, we studied the prevalence of psychosis-risk symptoms and criteria, their clinical relevance (using presence of a non-psychotic mental disorder or of functional deficits as proxy measures) and their risk factors in a random, representative young adult community sample (N=2683; age 16-40 years; response rate: 63.4%). The point-prevalence of psychosis-risk symptoms was 13.8%. As these mostly occurred too infrequent to meet frequency requirements of psychosis-risk criteria, only 2.4% of participants met psychosis-risk criteria. A stepwise relationship underlay the association of ultra-high risk and basic symptoms with proxy measures of clinical relevance, this being most significant when both occurred together. In line with models of their formation, basic symptoms were selectively associated with age, ultra-high risk symptoms with traumatic events and lifetime substance misuse. Psychosis-risk criteria were uncommon, indicating little risk of falsely labelling individuals from the community at-risk for psychosis. Besides, both psychosis-risk symptoms and criteria seem to possess sufficient clinical relevance to warrant their broader attention in clinical practice, especially if ultra-high risk and basic symptoms occur together.

  6. Clinical risk management in mental health: a qualitative study of main risks and related organizational management practices.

    PubMed

    Briner, Matthias; Manser, Tanja

    2013-02-04

    A scientific understanding of clinical risk management (CRM) in mental health care is essential for building safer health systems and for improving patient safety. While evidence on patient safety and CRM in physical health care has increased, there is limited research on these issues in mental health care. This qualitative study provides an overview of the most important clinical risks in mental health and related organizational management practices. We conducted in-depth expert interviews with professionals responsible for CRM in psychiatric hospitals. Interviews were transcribed and analyzed applying qualitative content analysis to thematically sort the identified risks. The main concerns for CRM in mental health are a) violence and self-destructive behavior (i.e. protecting patients and staff from other patients, and patients from themselves), b) treatment errors, especially in the process of therapy, and c) risks associated with mental illnesses (e.g. psychosis or depression). This study identified critical differences to CRM in hospitals for physical disorder and challenges specific to CRM in mental health. Firstly, many psychiatric patients do not believe that they are ill and are therefore in hospital against their will. Secondly, staff safety is a much more prominent theme for CRM in mental health care as it is directly related to the specifics of mental illnesses. The current study contributes to the understanding of patient safety and raises awareness for CRM in mental health. The mental health specific overview of central risks and related organizational management practices offers a valuable basis for CRM development in mental health and an addition to CRM in general.

  7. 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

  8. 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. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. Building a normative decision support system for clinical and operational risk management in hemodialysis.

    PubMed

    Cornalba, Chiara; Bellazzi, Roberto G; Bellazzi, Riccardo

    2008-09-01

    This paper describes the design and implementation of a decision support system for risk management in hemodialysis (HD) departments. The proposed system exploits a domain ontology to formalize the problem as a Bayesian network. It also relies on a software tool, able to automatically collect HD data, to learn the network conditional probabilities. By merging prior knowledge and the available data, the system allows to estimate risk profiles both for patients and HD departments. The risk management process is completed by an influence diagram that enables scenario analysis to choose the optimal decisions that mitigate a patient's risk. The methods and design of the decision support tool are described in detail, and the derived decision model is presented. Examples and case studies are also shown. The tool is one of the few examples of normative system explicitly conceived to manage operational and clinical risks in health care environments.

  10. 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

  11. [Clinical features and magnetic resonance imaging evaluation of encephalopathy in high-risk late preterm infants].

    PubMed

    Zhu, Yan; Zhang, Ke; Hu, Lan; Xiao, Mi-Li; Li, Zhi-Hua; Chen, Chao

    2017-05-01

    To investigate the risk factors, clinical features, and magnetic resonance imaging (MRI) changes of encephalopathy in high-risk late preterm infants. Head MRI scan was performed for late preterm infants with high-risk factors for brain injury who were hospitalized between January 2009 and December 2014. The risk factors, clinical features, and head MRI features of encephalopathy in late preterm infants were analyzed. A total of 1 007 late preterm infants underwent MRI scan, among whom 313 (31.1%) had imaging features in accordance with the features of encephalopathy of prematurity. Of all infants, 76.7% had white matter damage. There was no association between the development of encephalopathy and gestational age in late preterm infants, but the detection rate of encephalopathy gradually increased with the increasing birth weight (P<0.05). The logistic regression analysis showed that a history of resuscitation was an independent risk factor for encephalopathy of prematurity (P<0.01). Encephalopathy of prematurity is commonly seen in high-risk late preterm infants, especially white matter damage. A history of resuscitation is an independent risk factor for encephalopathy in late preterm infants.

  12. Smoking history and Alzheimer's disease risk in a community-based clinic population.

    PubMed

    Saito, Erin K; Diaz, Natalie; Chung, Julia; McMurtray, Aaron

    2017-01-01

    The relationship between cigarette smoking and development of Alzheimer's disease (AD) is not fully determined, and previous reports disagree, with some studies suggesting an increased relative risk and others a decreased odds ratio. Consequently, we wanted to determine if the prevalence of past cigarette smoking observed in a community-based clinic sample of patients with AD would be more consistent with the expected value obtained from a model using either an increased relative risk or a decreased odds ratio to estimate the effect of smoking on development of AD. Retrospective cross-sectional analysis of all patients treated for AD in a community-based Neurology Clinic during a 2-year period. Estimates of expected past smoking prevalence were calculated based on published values for either an increased relative risk or a decreased odds ratio and compared to the past smoking prevalence observed in the clinic sample. The observed past smoking prevalence in the clinic population was 29.17%. The expected past smoking prevalence calculated using the increased relative risk was 30.07% (95% confidence interval [CI] = 27.67-32.32%), and using the decreased odds ratio was 12.54% (95% CI = 6.32-24.81%). The observed past smoking prevalence among the patients being treated for AD in a community-based clinic falls within the expected 95% CI for the increased relative risk model and outside of the expected 95% CI for the decreased odds ratio model. These results support the contention that the relationship between cigarette smoking and development of AD is the best characterized by an increased relative risk.

  13. Clinical- and imaging-based prediction of stroke risk after transient ischemic attack: the CIP model.

    PubMed

    Ay, Hakan; Arsava, E Murat; Johnston, S Claiborne; Vangel, Mark; Schwamm, Lee H; Furie, Karen L; Koroshetz, Walter J; Sorensen, A Gregory

    2009-01-01

    Predictive instruments based on clinical features for early stroke risk after transient ischemic attack suffer from limited specificity. We sought to combine imaging and clinical features to improve predictions for 7-day stroke risk after transient ischemic attack. We studied 601 consecutive patients with transient ischemic attack who had MRI within 24 hours of symptom onset. A logistic regression model was developed using stroke within 7 days as the response criterion and diffusion-weighted imaging findings and dichotomized ABCD(2) score (ABCD(2) >/=4) as covariates. Subsequent stroke occurred in 25 patients (5.2%). Dichotomized ABCD(2) score and acute infarct on diffusion-weighted imaging were each independent predictors of stroke risk. The 7-day risk was 0.0% with no predictor, 2.0% with ABCD(2) score >/=4 alone, 4.9% with acute infarct on diffusion-weighted imaging alone, and 14.9% with both predictors (an automated calculator is available at http://cip.martinos.org). Adding imaging increased the area under the receiver operating characteristic curve from 0.66 (95% CI, 0.57 to 0.76) using the ABCD(2) score to 0.81 (95% CI, 0.74 to 0.88; P=0.003). The sensitivity of 80% on the receiver operating characteristic curve corresponded to a specificity of 73% for the CIP model and 47% for the ABCD(2) score. Combining acute imaging findings with clinical transient ischemic attack features causes a dramatic boost in the accuracy of predictions with clinical features alone for early risk of stroke after transient ischemic attack. If validated in relevant clinical settings, risk stratification by the CIP model may assist in early implementation of therapeutic measures and effective use of hospital resources.

  14. The German clinical risk management survey for hospitals: Implementation levels and areas for improvement in 2015.

    PubMed

    Manser, Tanja; Frings, Janina; Heuser, Gregory; Mc Dermott, Fiona

    2016-01-01

    Despite the growing recognition of the need to implement systematic approaches for managing the risks associated with healthcare, few studies have investigated the level of implementation for clinical risk management (CRM) at a national level. Therefore, this study aimed to assess the current level of CRM implementation in German hospitals and to explore differences across hospital types. From March to June 2015, persons responsible for CRM in 2,617 hospitals and rehabilitation clinics in Germany were invited to participate in a voluntary online survey assessing the level of implementation for various aspects of CRM: CRM strategy, structures and processes; risk assessment (risk identification, risk analysis, risk evaluation) with a focus on incident reporting systems; risk mitigation measures; and risk monitoring and reporting. 572 hospitals participated in the survey (response rate 22 %). Most of these hospitals had a formalised, binding CRM strategy (72 %). 66 % had a centralised and 34 % a decentralised CRM structure. We also found that, despite a broad range of risk assessment methods being applied, there was a lack of integration of risk information from different data sources. Hospitals also reported a high level of implementation of critical incident reporting systems with a strong preference for local (74 %) over transorganisational systems. This study provides relevant data to inform targeted interventions concerning CRM implementation at a national level and to consider the specific context of different types of hospitals more carefully in this process. The approach to CRM assessment illustrated in this article could be the basis of a system for monitoring CRM over time and, thus, for evaluating the impact of strategy decisions at the policy level on CRM development. Copyright © 2016. Published by Elsevier GmbH.

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

    PubMed Central

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

    2014-01-01

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

  16. Estimating Cardiovascular Risk in Spain by the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice.

    PubMed

    Amor, Antonio Jesús; Masana, Luis; Soriguer, Federico; Goday, Albert; Calle-Pascual, Alfonso; Gaztambide, Sonia; Rojo-Martínez, Gemma; Valdés, Sergio; Gomis, Ramón; Ortega, Emilio

    2015-05-01

    There are no nationwide, population-based studies in Spain assessing overall cardiovascular risk. We aimed to describe cardiovascular risk and achievement of treatment goals following the 2012 European Guidelines on cardiovascular disease prevention strategy. We also investigated clinical characteristics (non-classical risk factors) associated with moderate risk. Participants (n=2310, 58% women) aged 40 to 65 years from a national population-based study (Di@bet.es Study) were identified. First, a priori high/very-high risk individuals were identified. Next, total cardiovascular risk (Systematic Coronary Risk Evaluation equation including high-density lipoprotein cholesterol) was used to assess risk of a priori non-high risk individuals. Variables independently associated with moderate versus low-risk were investigated by multiple logistic regression analysis. Age-and-sex standardized (direct method) percentages of high/very-high, moderate, and low-risk were 22.8%, 43.5%, and 33.7%, respectively. Most men were at moderate (56.2%), while 55.4% of women were at low risk. Low-density lipoprotein cholesterol (< 70,<100, < 115 mg/dL) and blood pressure (<140/90 mmHg) goals for very-high, high and moderate risk were met in 15%, 26% and 46%, and 77%, 68% and 85% of the individuals, respectively. Body mass index, high triglycerides concentrations, diastolic blood pressure, and low Mediterranean diet adherence (in women) were independently associated with moderate (versus low) risk. Cardiovascular risk in Spain is mainly moderate in men and low in women. Achievement of treatment goals in high-risk individuals should be improved. The prevalence of non-classical cardiovascular risk factors is elevated in subjects at moderate risk, an important aspect to consider in a population-based strategy to decrease cardiovascular disease in the most prevalent group. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  17. A Mobile Clinical Decision Support Tool for Pediatric Cardiovascular Risk-Reduction Clinical Practice Guidelines: Development and Description

    PubMed Central

    2017-01-01

    Background Widespread application of research findings to improve patient outcomes remains inadequate, and failure to routinely translate research findings into daily clinical practice is a major barrier for the implementation of any evidence-based guideline. Strategies to increase guideline uptake in primary care pediatric practices and to facilitate adherence to recommendations are required. Objective Our objective was to operationalize the US National Heart, Lung, and Blood Institute’s Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents into a mobile clinical decision support (CDS) system for healthcare providers, and to describe the process development and outcomes. Methods To overcome the difficulty of translating clinical practice guidelines into a computable form that can be used by a CDS system, we used a multilayer framework to convert the evidence synthesis into executable knowledge. We used an iterative process of design, testing, and revision through each step in the translation of the guidelines for use in a CDS tool to support the development of 4 validated modules: an integrated risk assessment; a blood pressure calculator; a body mass index calculator; and a lipid management instrument. Results The iterative revision process identified several opportunities to improve the CDS tool. Operationalizing the integrated guideline identified numerous areas in which the guideline was vague or incorrect and required more explicit operationalization. Iterative revisions led to workable solutions to problems and understanding of the limitations of the tool. Conclusions The process and experiences described provide a model for other mobile CDS systems that translate written clinical practice guidelines into actionable, real-time clinical recommendations. PMID:28270384

  18. 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.

  19. Psychosis Prevention: A Modified Clinical High Risk Perspective From the Recognition and Prevention (RAP) Program

    PubMed Central

    Cornblatt, Barbara A.; Carrión, Ricardo E.; Auther, Andrea; McLaughlin, Danielle; Olsen, Ruth H.; John, Majnu; Correll, Christoph U.

    2016-01-01

    Objective Early intervention and prevention of psychosis remain a major challenge. Prediction would be greatly advanced with improved ability to identify individuals at true risk, which, at present, is moderate at best. The authors tested a modified strategy to improve prediction by selecting a more homogeneous high-risk sample (attenuated positive symptom criteria only, age range of mid-teens to early 20s) than is currently standard, combined with a systematic selection of neurodevelopmental deficits. Method A sample of 101 treatment-seeking adolescents (mean age, 15.9 years) at clinical high risk for psychosis were followed clinically for up to 5 years (mean follow-up time, 3.0 years, SD=1.6). Adolescents were included only if they exhibited one or more attenuated positive symptoms at moderate to severe, but not psychotic, severity levels. Cox regression was used to derive a risk index. Results The overall conversion rate to psychosis was 28.3%. The final predictor model, with a positive predictive validity of 81.8%, consisted of four variables: disorganized communication, suspiciousness, verbal memory deficits, and decline in social functioning during follow-up. Significant effects also suggest narrowing the risk age range to 15–22 years. Conclusions Clinical high risk criteria that emphasize disorganized communication and suspiciousness while also including compromised verbal memory and declining social functioning have the potential to improve predictive accuracy compared with attenuated positive symptoms used alone. On the resulting risk index (a weighted combination of the predictors), low scores were interpreted as signifying minimal risk, with little treatment necessary, high scores as suggesting aggressive intervention, and intermediate scores, although less informative, as supporting psychosocial treatment. PMID:26046336

  20. American Society of Clinical Oncology technology assessment on breast cancer risk reduction strategies: tamoxifen and raloxifene.

    PubMed

    Chlebowski, R T; Collyar, D E; Somerfield, M R; Pfister, D G

    1999-06-01

    To conduct an evidence-based technology assessment to determine whether tamoxifen and raloxifene as breast cancer risk-reduction strategies are appropriate for broad-based conventional use in clinical practice. Tamoxifen and raloxifene. Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefits. A comprehensive, formal literature review was conducted for tamoxifen and raloxifene on the following topics: breast cancer risk reduction; tamoxifen side effects and toxicity, including endometrial cancer risk; tamoxifen influences on nonmalignant diseases, including coronary heart disease and osteoporosis; and decision making by women at risk for breast cancer. Testimony was collected from invited experts and interested parties. More weight was given to publications that described randomized trials. BENEFITS/HARMS/COSTS: The American Society of Clinical Oncology (ASCO) Working Group acknowledges that a woman's decision regarding breast cancer risk-reduction strategies will depend on the importance and weight attributed to the information provided regarding both cancer and non-cancer-related risks. For women with a defined 5-year projected risk of breast cancer of >/= 1.66%, tamoxifen (at 20 mg/d for up to 5 years) may be offered to reduce their risk. It is premature to recommend raloxifene use to lower the risk of developing breast cancer outside of a clinical trial setting. On the basis of available information, use of raloxifene should currently be reserved for its approved indication to prevent bone loss in postmenopausal women. Conclusions are based on single-agent use of the drugs. At the present time, the effect of using tamoxifen or raloxifene with other medications (such as hormone replacement therapy), or using tamoxifen and raloxifene in combination or sequentially, has not been studied adequately. The continuing use of placebo-controlled trials in other risk-reduction trials highlights the

  1. Clinical outcomes and risk factors for perforation in gastric endoscopic submucosal dissection: A prospective pilot study

    PubMed Central

    Watari, Jiro; Tomita, Toshihiko; Toyoshima, Fumihiko; Sakurai, Jun; Kondo, Takashi; Asano, Haruki; Yamasaki, Takahisa; Okugawa, Takuya; Ikehara, Hisatomo; Oshima, Tadayuki; Fukui, Hirokazu; Miwa, Hiroto

    2013-01-01

    AIM: To evaluate clinical outcomes and risk factors for endoscopic perforation during endoscopic submucosal dissection (ESD) in a prospective study. METHODS: We investigated the clinical outcomes and risk factors for the development of perforation in 98 consecutive gastric neoplasms undergoing ESD regarding. Demographic and clinical parameters including patient-, tumor-, and treatment-related factors, clinical parameters, and duration of hospital stay were analyzed for risk factors for perforation. In subgroup analysis, we also compared the clinical outcomes between perforation and “silent” free air without endoscopically visible perforation detected only by computed tomography. RESULTS: Perforation was identified in 8.2% of patients. All patients were managed conservatively by the administration of antibiotics. The mean procedure time was significantly longer in patients with endoscopic perforation than in those without. According to the receiver-operating characteristic analysis, the resulting cutoff value of the procedure time for perforation was 115 min (87.5% sensitivity, 56.7% specificity). Prolonged procedure time (≥ 115 min) was associated with an increased risk of perforation (odds ratio 9.15; 95%CI: 1.08-77.54; P = 0.04). Following ESD, body temperature and C-reactive protein level were significantly higher in patients with perforation than in those without (P = 0.02), whereas there was no difference between these patient groups on the starting day of oral intake or of hospitalization. In subgroup analysis, the post-ESD clinical course was not different between endoscopic perforation and silent free air. CONCLUSION: Only prolonged procedure time (≥ 115 min) was significantly associated with perforation. The clinical outcomes of perforation are favorable and are comparable to those of patients with or without silent free air. PMID:23772265

  2. Clinical outcomes and risk factors for perforation in gastric endoscopic submucosal dissection: A prospective pilot study.

    PubMed

    Watari, Jiro; Tomita, Toshihiko; Toyoshima, Fumihiko; Sakurai, Jun; Kondo, Takashi; Asano, Haruki; Yamasaki, Takahisa; Okugawa, Takuya; Ikehara, Hisatomo; Oshima, Tadayuki; Fukui, Hirokazu; Miwa, Hiroto

    2013-06-16

    To evaluate clinical outcomes and risk factors for endoscopic perforation during endoscopic submucosal dissection (ESD) in a prospective study. We investigated the clinical outcomes and risk factors for the development of perforation in 98 consecutive gastric neoplasms undergoing ESD regarding. Demographic and clinical parameters including patient-, tumor-, and treatment-related factors, clinical parameters, and duration of hospital stay were analyzed for risk factors for perforation. In subgroup analysis, we also compared the clinical outcomes between perforation and "silent" free air without endoscopically visible perforation detected only by computed tomography. Perforation was identified in 8.2% of patients. All patients were managed conservatively by the administration of antibiotics. The mean procedure time was significantly longer in patients with endoscopic perforation than in those without. According to the receiver-operating characteristic analysis, the resulting cutoff value of the procedure time for perforation was 115 min (87.5% sensitivity, 56.7% specificity). Prolonged procedure time (≥ 115 min) was associated with an increased risk of perforation (odds ratio 9.15; 95%CI: 1.08-77.54; P = 0.04). Following ESD, body temperature and C-reactive protein level were significantly higher in patients with perforation than in those without (P = 0.02), whereas there was no difference between these patient groups on the starting day of oral intake or of hospitalization. In subgroup analysis, the post-ESD clinical course was not different between endoscopic perforation and silent free air. Only prolonged procedure time (≥ 115 min) was significantly associated with perforation. The clinical outcomes of perforation are favorable and are comparable to those of patients with or without silent free air.

  3. 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…

  4. Clinical presentation, risk factors and outcome of stroke at a district level teaching hospital.

    PubMed

    Masood, Choudhary Tariq; Hussain, Maqbool; Anis-ur-Rehman; Abbasi, Saleem

    2013-01-01

    Stroke is a fatal clinical syndrome with mortality rate ranging up to 25%. Hypertension, smoking and diabetes mellitus are common preventable risk factors which are associated with serious outcome. Objective of this study was to determine the clinical presentation, risk factors and outcome of stroke. A cross-sectional study was conducted in the Medical Wards of DHQ Teaching Hospital, Mirpur Azad Kashmir from March 2010 to January 2011. A questionnaire was prepared in accordance with the objectives of the study. Frequency of risk factors in patients with stroke were studied. Different clinical features were also noted and response to the given treatment was checked in the form of mortality and recovery. Frequencies and percentages were calculated using SPSS-12. Two hundred patients with stroke were selected. Of the total, 136 (68%) had hypertension, 55 (27.5%) were smokers, 53 (26.5%) had diabetes and 25 (12.5%) patients had ischemic heart disease. One hundred and two (51%) patients presented with headache, 99 (49.5%) developed hemiplegia and 94 (47%) had loss of consciousness. CT brain showed infarction in 144 (72%) patients while 56 (28%) had haemorrhage. Observed mortality in this study was 18 (9%) while 182 (91%) patients were discharged after treatment. Hypertension, smoking and diabetes mellitus are major modifiable risk factors for stroke. Headache, hemiplegia and loss of consciousness are major clinical features. Ischemic stroke is much common compared to hemorrhagic stroke. With proper care stroke is manageable satisfactorily.

  5. Clinical assessment of psychotic and mood disorder symptoms for risk of future violence.

    PubMed

    Scott, Charles L; Resnick, Phillip J

    2014-10-01

    This article reviews important components to consider when evaluating the relationship of psychotic and mood disorder symptoms to violence. Particular attention is given to assessing persecutory delusions and command auditory hallucinations. Clinical implications of research findings to evaluating violence risk in psychiatric patients are reviewed.

  6. 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…

  7. 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…

  8. Emotion recognition in individuals at clinical high-risk for schizophrenia.

    PubMed

    Amminger, G Paul; Schäfer, Miriam R; Papageorgiou, Konstantinos; Klier, Claudia M; Schlögelhofer, Monika; Mossaheb, Nilufar; Werneck-Rohrer, Sonja; Nelson, Barnaby; McGorry, Patrick D

    2012-09-01

    Problems in the perception of emotional material, in particular deficits in the recognition of negative stimuli, have been demonstrated in schizophrenia including in first-episode samples. However, it is largely unknown if emotion recognition impairment is present in people with subthreshold psychotic symptoms. Here, we examined the capacity to recognize facially expressed emotion and affective prosody in 79 individuals at ultra high-risk for psychosis, 30 clinically stable individuals with first-episode schizophrenia assessed as outpatients during the early recovery phase of illness, and 30 unaffected healthy control subjects. We compared (1) scores for a combined fear-sadness aggregate index across face and voice modalities, (2) summary scores of specific emotions across modalities, and (3) scores for specific emotions for each sensory modality. Findings supported deficits in recognition of fear and sadness across both modalities for the clinical groups (the ultra high-risk and first-episode group) as compared with the healthy controls. Furthermore, planned contrasts indicated that compared with the healthy control subjects, both clinical groups had a significant deficit for fear and sadness recognition in faces and for anger recognition in voices. Specific impairments in emotion recognition may be apparent in people at clinical high-risk for schizophrenia before the full expression of psychotic illness. The results suggest a trait deficit and an involvement of the amygdala in the pathology of ultra high-risk states.

  9. 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…

  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. HPA-axis function, symptoms, and medication exposure in youths at clinical high risk for psychosis.

    PubMed

    Sugranyes, G; Thompson, J L; Corcoran, C M

    2012-11-01

    Increased basal cortisol secretion has been associated with heightened clinical risk for psychosis, and among at-risk individuals, has been variably related to positive and mood symptoms, as well as clinical outcome. Basal salivary cortisol secretion was assessed in 33 patients at clinical high risk (CHR) for psychosis (21 medication-free and 12 taking a serotonin reuptake inhibitor and/or atypical antipsychotic), and 13 healthy controls. Among the CHR patients, we also examined associations of basal salivary cortisol with symptoms (positive, negative, mood, stress sensitivity) and clinical outcome. Basal salivary cortisol secretion was significantly higher in CHR patients who were medication-free compared to CHR patients taking medications and to healthy controls. In this small cohort, basal salivary cortisol secretion was associated at trend level with stress sensitivity, and was not significantly related to other symptoms. Our finding of elevated basal cortisol secretion in CHR patients supports the premise that excess activation of the HPA axis and/or neuroendocrine abnormalities characterize the psychosis risk state for at least a subset of patients. Our findings further suggest that psychotropic medications may have a normalizing effect on HPA-axis dysfunction in CHR patients, which could potentially inform intervention strategies for the prodrome. Copyright © 2012 Elsevier Ltd. All rights reserved.

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  13. 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.

  14. 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

  15. The inclusion of cognition in vascular risk factor clinical practice guidelines

    PubMed Central

    Rockwood, Kenneth; Middleton, Laura E; Moorhouse, Paige K; Skoog, Ingmar; Black, Sandra E

    2009-01-01

    Background: People with vascular risk factors are at increased risk for cognitive impairment as well as vascular disease. The objective of this study was to evaluate whether vascular risk factor clinical practice guidelines consider cognition as an outcome or in connection with treatment compliance. Methods: Articles from PubMed, EMBASE, and the Cochrane Library were assessed by at least two reviewers and were included if: (1) Either hypertension, high cholesterol, diabetes, or atrial fibrillation was targeted; (2) The guideline was directed at physicians; (3) Adult patients (aged 19 years or older) were targeted; and (4) The guideline was published in English. Of 91 guidelines, most were excluded because they were duplicates, older versions, or focused on single outcomes. Results: Of the 20 clinical practice guidelines that met inclusion criteria, five mentioned cognition. Of these five, four described potential treatment benefits but only two mentioned that cognition may affect compliance. No guidelines adequately described how to screen for cognitive impairment. Conclusion: Despite evidence that links cognitive impairment to vascular risk factors, only a minority of clinical practice guidelines for the treatment of vascular risk factors consider cognition as either an adverse outcome or as a factor to consider in treatment. PMID:19966911

  16. Genetic and Clinical Predictors for Breast Cancer Risk Assessment and Stratification Among Chinese Women

    PubMed Central

    Wen, Wanqing; Gao, Yu-Tang; Shyr, Yu; Long, Jirong; Li, Guoliang; Li, Chun; Gu, Kai; Cai, Qiuyin; Shu, Xiao-Ou; Lu, Wei

    2010-01-01

    Background Most of the genetic variants identified from genome-wide association studies of breast cancer have not been validated in Asian women. No risk assessment model that incorporates both genetic and clinical predictors is currently available to predict breast cancer risk in this population. Methods We analyzed 12 single-nucleotide polymorphisms (SNPs) identified in recent genome-wide association studies mostly of women of European ancestry as being associated with the risk of breast cancer in 3039 case patients and 3082 control subjects who participated in the Shanghai Breast Cancer Study. All participants were interviewed in person to obtain information regarding known and suspected risk factors for breast cancer. The c statistic, a measure of discrimination ability with a value ranging from 0.5 (random classification) to 1.0 (perfect classification), was estimated to evaluate the contribution of genetic and established clinical predictors of breast cancer to a newly established risk assessment model for Chinese women. Clinical predictors included in the model were age at menarche, age at first live birth, waist-to-hip ratio, family history of breast cancer, and a previous diagnosis of benign breast disease. The utility of the models in risk stratification was evaluated by estimating the proportion of breast cancer patients in the general population that could be accounted for above a given risk threshold as predicted by the models. All statistical tests were two-sided. Results Eight SNPs (rs2046210, rs1219648, rs3817198, rs8051542, rs3803662, rs889312, rs10941679, and rs13281615), each of which reflected a genetically independent locus, were found to be associated with the risk of breast cancer. A dose–response association was observed between the risk of breast cancer and the genetic risk score, which is an aggregate measure of the effect of these eight SNPs (odds ratio for women in the highest quintile of genetic risk score vs those in the lowest = 1

  17. Ankylosing spondylitis confers substantially increased risk of clinical spine fractures: a nationwide case-control study.

    PubMed

    Prieto-Alhambra, D; Muñoz-Ortego, J; De Vries, F; Vosse, D; Arden, N K; Bowness, P; Cooper, C; Diez-Perez, A; Vestergaard, P

    2015-01-01

    Ankylosing spondylitis (AS) leads to osteopenia/osteoporosis and spine rigidity. We conducted a case-control study and found that AS-affected patients have a 5-fold and 50% increased risk of clinical spine and all clinical fractures, respectively. Excess risk of both is highest in the first years and warrants an early bone health assessment after diagnosis. Ankylosing spondylitis (AS) is related to spine rigidity and reduced bone mass, but data on its impact on fracture risk are scarce. We aimed to study the association between AS and clinical fractures using a case-control design. From the Danish Health Registries, we identified all subjects who sustained a fracture in the year 2000 (cases) and matched up to three controls by year of birth, gender and region. Clinically diagnosed AS was identified using International Classification of Diseases, 8th revision (ICD-8; 71249), and International Classification of Diseases, 10th revision (ICD-10; M45) codes. We also studied the impact of AS duration. Conditional logistic regression was used to estimate crude and adjusted odds ratios (ORs) for non-traumatic fractures (any site, clinical spine and non-vertebral) according to AS status and time since AS diagnosis. Multivariate models were adjusted for fracture history, socio-economic status, previous medical consultations, alcoholism and use of oral glucocorticoids. We identified 139/124,655 (0.11%) AS fracture cases, compared to 271/373,962 (0.07%) AS controls. Unadjusted (age- and gender-matched) odds ratio (OR) were 1.54 [95% confidence interval (95%CI) 1.26-1.89] for any fracture, 5.42 [2.50-11.70] for spine and 1.39 [1.12-1.73] for non-vertebral fracture. The risk peaked in the first 2.5 years following AS diagnosis: OR 2.69 [1.84-3.92] for any fracture. Patients with AS have a 5-fold higher risk of clinical spine fracture and a 35% increased risk of non-vertebral fracture. This excess risk peaks early, in the first 2.5 years of AS disease. Patients should be assessed

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

    PubMed

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

    2015-01-01

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

  19. Severe bacterial infections in patients with non-transfusion-dependent thalassemia: prevalence and clinical risk factors.

    PubMed

    Teawtrakul, Nattiya; Jetsrisuparb, Arunee; Sirijerachai, Chittima; Chansung, Kanchana; Wanitpongpun, Chinadol

    2015-10-01

    Bacterial infection is one of the major causes of death in patients with thalassemia. Clinical predictive factors for severe bacterial infection were evaluated in patients with non-transfusion-dependent thalassemia (NTDT). A retrospective study was conducted of patients with NTDT aged ≥ 10 years at Srinagarind Hospital, Khon Kaen University, Thailand. Clinical characteristics and potential clinical risk factors for bacterial infection were collected. Risk factors for bacterial infection were evaluated by multivariate logistic regression analysis. A severe bacterial infection was found in 11 of the total 211 patients with NTDT (5.2%). None of the clinical factors assessed was shown to be statistically associated with severe bacterial infection in patients with NTDT. However, three factors were demonstrated to be potential predictive factors for severe bacterial infection: time after splenectomy >10 years, deferoxamine therapy, and serum ferritin >1000 ng/ml. None of the patients died from infection. The prevalence of bacterial infection in patients with NTDT was found to be moderate. Time after splenectomy >10 years, deferoxamine therapy, and iron overload may be clinical risk factors for severe bacterial infection in patients with NTDT. Bacterial infection should be recognized in splenectomized patients with NTDT, particularly those who have an iron overload. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. Clinical signs, therapy and zoonotic risk of pet guinea pigs with dermatophytosis.

    PubMed

    Kraemer, A; Hein, J; Heusinger, A; Mueller, R S

    2013-03-01

    Systematic studies about pet guinea pigs with dermatophytosis are rare. The aim of this study was to evaluate clinical signs, therapy and zoonotic risk of pet guinea pigs with dermatophytosis. Questionnaires from both owners (n = 74) of pet guinea pigs with dermatophytosis and their veterinarians (n = 101) were analysed regarding clinical signs, therapy and data pertinent to zoonotic potential. Trichophyton (T.) mentagrophytes was found in 97% of cases. In the weeks preceding the onset of the clinical signs, a new guinea pig joined the household in 43% of cases. One third of the affected guinea pigs had lived in the household for less than 3 months. Predominant clinical signs were alopecia (83%), scaling (73%) and crusting (70%). The most commonly affected body site was the head (75%). In approximately one quarter of the cases humans showed clinical signs of dermatophytosis, in half the households, only children were affected. Skin lesions were seen most often on the face, the neck and the arms. Pet guinea pigs carrying dermatophytes must be considered a serious zoonotic risk for their owners, especially for children. A major risk factor for dermatophytosis seems to be a recent acquisition of a new guinea pig.

  1. Risk levels, treatment duration, and drop out in a clinically composed outpatient sex offender treatment group.

    PubMed

    Smid, Wineke J; Kamphuis, Jan H; Wever, Edwin C; Verbruggen, Maud C F M

    2015-03-01

    Previous research in the Netherlands documented that clinical judgment may yield a substantial amount of treatment referrals for sexual offenders that are inconsistent with actuarial risk assessment and the Risk Need Responsivity (RNR) principles. The present study tested the risk level distribution of a high-intensity, open-format outpatient treatment group. Eighty patients were enrolled during a 620-week period, and their STATIC-99R risk levels were retrospectively determined. The distribution of risk levels in this treatment group did not differ from the distribution of a representative sample of sex offenders referred to outpatient treatment in the Netherlands between 1996 and 2002 (n = 145), nor from the combined Canadian samples (n = 2011) used to assess STATIC-99R normative percentile. These findings suggest that no selection in terms of actuarial risk level occurred between conviction and treatment, leading to over-inclusion of low risk offenders in this high-intensity outpatient treatment group. It is concluded that the standard use of structured risk assessment for the compilation of treatment groups may improve both the effectiveness and efficiency of sex offender treatment in the Netherlands.

  2. Review of clinical practice guidelines for the management of LDL-related risk.

    PubMed

    Morris, Pamela B; Ballantyne, Christie M; Birtcher, Kim K; Dunn, Steven P; Urbina, Elaine M

    2014-07-15

    Managing risk related to low-density lipoprotein (LDL) is vital in therapy for patients at risk for atherosclerotic cardiovascular disease (ASCVD) events given its important etiologic role in atherogenesis. Despite decades of research showing reduction of ASCVD risk with multiple approaches to lowering of LDL cholesterol, there continue to be significant gaps in care with inadequate numbers of patients receiving standard of care lipid-lowering therapy. Confusion regarding implementation of the multiple published clinical practice guidelines has been identified as one contributor to suboptimal management of LDL-related risk. This review summarizes the current guidelines for reduction of LDL-related cardiovascular risk provided by a number of major professional societies, which have broad applicability to diverse populations worldwide. Statements have varied in the process and methodology of development of recommendations, the grading system for level and strength of evidence, the inclusion or exclusion of expert opinion, the suggested ASCVD risk assessment tool, the lipoproteins recommended for risk assessment, and the lipoprotein targets of therapy. The similarities and differences among important guidelines in the United States and internationally are discussed, with recommendations for future strategies to improve consistency in approaches to LDL-related ASCVD risk and to reduce gaps in implementation of evidence-based therapies. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

    PubMed

    Fresco, Rodrigo; Spera, Gonzalo; Meyer, Carlos; Cabral, Pablo; Mackey, John R

    2015-07-01

    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. 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. 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). 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. Medical imaging is key in breast cancer (BC) clinical trials. Most of these procedures expose patients to ionizing radiation, and the risk

  4. 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

  5. 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.

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

    PubMed

    Cha, Eugene K; Eastham, James A

    2015-05-01

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

  7. Audio computer assisted interviewing to measure HIV risk behaviours in a clinic population

    PubMed Central

    Rogers, S; Willis, G; Al-Tayyib, A; Villarroel, M; Turner, C; Ganapathi, L; Zenilman, J; Jadack, R

    2005-01-01

    Methods: 1350 clinic patients were assigned to complete a detailed behavioural survey on sexual risk practices, previous STIs and symptoms, condom use, and drug and alcohol use using either ACASI or IAQ. Results: Respondents assigned to ACASI were more likely to report recent risk behaviours such as sex without a condom in the past 24 hours (adjusted OR = 1.9), anal sex (adjusted OR = 2.0), and one or more new partners in the past 6 months (adjusted OR = 1.5) compared to those interviewed by IAQ. The impact of ACASI varied by sex but, contrary to expectations, not by whether the patient had previously visited an STI clinic. Mode of survey administration made little difference within this population in reports of STI knowledge, previous STIs, STI symptoms, or illicit drug use. Conclusion: ACASI provides a useful tool for improving the quality of behavioural data in clinical environments. PMID:16326855

  8. Risk Factors and Predictive Clinical Scores for Asthma Exacerbations in Childhood

    PubMed Central

    Forno, Erick; Fuhlbrigge, Anne; Soto-Quirós, Manuel E.; Avila, Lydiana; Raby, Benjamin A.; Brehm, John; Sylvia, Jody M.; Weiss, Scott T.

    2010-01-01

    Background: Asthma is a major public health problem that affects millions of children worldwide, and exacerbations account for most of its morbidity and costs. Primary-care providers lack efficient tools to identify children at high risk for exacerbations. We aimed to construct a clinical score to help providers to identify such children. Methods: Our main outcome was severe asthma exacerbation, which was defined as any hospitalization, urgent visit, or systemic steroid course for asthma in the previous year, in children. A clinical score, consisting of a checklist questionnaire made up of 17 yes-no questions regarding asthma symptoms, use of medications and health-care services, and history, was built and validated in a cross-sectional study of Costa Rican children with asthma. It was then evaluated using data from the Childhood Asthma Management Program (CAMP), a longitudinal trial cohort of North American children. Results: Compared with children at average risk for an exacerbation in the Costa Rican validation set, the odds of an exacerbation among children in the low-risk (OR, 0.2; 95% CI, 0.1-0.4) and high-risk (OR, 5.4; 95% CI, 1.5-19.2) score categories were significantly reduced and increased, respectively. In CAMP, the hazard ratios for an exacerbation after 1-year follow-up in the low-risk and high-risk groups were 0.6 (95% CI, 0.5-0.7) and 1.9 (95% CI, 1.4-2.4), respectively, with similar results at 2 years. Conclusions: The proposed Asthma Exacerbation Clinical Score is simple to use and effective at identifying children at high and low risk for asthma exacerbations. The tool can easily be used in primary-care settings. PMID:20472862

  9. Perioperative aspirin and clonidine and risk of acute kidney injury: a randomized clinical trial.

    PubMed

    Garg, Amit X; Kurz, Andrea; Sessler, Daniel I; Cuerden, Meaghan; Robinson, Andrea; Mrkobrada, Marko; Parikh, Chirag R; Mizera, Richard; Jones, Philip M; Tiboni, Maria; Font, Adrià; Cegarra, Virginia; Gomez, Maria Fernanda Rojas; Meyhoff, Christian S; VanHelder, Tomas; Chan, Matthew T V; Torres, David; Parlow, Joel; Clanchet, Miriam de Nadal; Amir, Mohammed; Bidgoli, Seyed Javad; Pasin, Laura; Martinsen, Kristian; Malaga, German; Myles, Paul; Acedillo, Rey; Roshanov, Pavel S; Walsh, Michael; Dresser, George; Kumar, Priya; Fleischmann, Edith; Villar, Juan Carlos; Painter, Thomas; Biccard, Bruce; Bergese, Sergio; Srinathan, Sadeesh; Cata, Juan P; Chan, Vincent; Mehra, Bhupendra; Wijeysundera, Duminda N; Leslie, Kate; Forget, Patrice; Whitlock, Richard; Yusuf, Salim; Devereaux, P J

    2014-12-03

    Acute kidney injury, a common complication of surgery, is associated with poor outcomes and high health care costs. Some studies suggest aspirin or clonidine administered during the perioperative period reduces the risk of acute kidney injury; however, these effects are uncertain and each intervention has the potential for harm. To determine whether aspirin compared with placebo, and clonidine compared with placebo, alters the risk of perioperative acute kidney injury. A 2 × 2 factorial randomized, blinded, clinical trial of 6905 patients undergoing noncardiac surgery from 88 centers in 22 countries with consecutive patients enrolled between January 2011 and December 2013. Patients were assigned to take aspirin (200 mg) or placebo 2 to 4 hours before surgery and then aspirin (100 mg) or placebo daily up to 30 days after surgery, and were assigned to take oral clonidine (0.2 mg) or placebo 2 to 4 hours before surgery, and then a transdermal clonidine patch (which provided clonidine at 0.2 mg/d) or placebo patch that remained until 72 hours after surgery. Acute kidney injury was primarily defined as an increase in serum creatinine concentration from the preoperative concentration by either an increase of 0.3 mg/dL or greater (≥26.5 μmol/L) within 48 hours of surgery or an increase of 50% or greater within 7 days of surgery. Aspirin (n = 3443) vs placebo (n = 3462) did not alter the risk of acute kidney injury (13.4% vs 12.3%, respectively; adjusted relative risk, 1.10; 95% CI, 0.96-1.25). Clonidine (n = 3453) vs placebo (n = 3452) did not alter the risk of acute kidney injury (13.0% vs 12.7%, respectively; adjusted relative risk, 1.03; 95% CI, 0.90-1.18). Aspirin increased the risk of major bleeding. In a post hoc analysis, major bleeding was associated with a greater risk of subsequent acute kidney injury (23.3% when bleeding was present vs 12.3% when bleeding was absent; adjusted hazard ratio, 2.20; 95% CI, 1.72-2.83). Similarly, clonidine

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

    PubMed

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

    2016-06-21

    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. The objective of the study was to assess the usability of a pediatric CVD risk factor tool by clinicians. 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. 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 incorporated into the design when feasible

  11. 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

  12. Correlation between the reason for referral, clinical, and objective assessment of the risk for dysphagia.

    PubMed

    Mancopes, Renata; Gonçalves, Bruna Franciele da Trindade; Costa, Cintia Conceição; Favero, Talita Cristina; Drozdz, Daniela Rejane Constantino; Bilheri, Diego Fernando Dorneles; Schumacher, Stéfani Fernanda

    2014-01-01

    To correlate the reason for referral to speech therapy service at a university hospital with the results of clinical and objective assessment of risk for dysphagia. This is a cross-sectional, observational, retrospective analytical and quantitative study. The data were gathered from the database, and the information used was the reason for referral to speech therapy service, results of clinical assessment of the risk for dysphagia, and also from swallowing videofluoroscopy. There was a mean difference between the variables of the reason for the referral, results of the clinical and objective swallowing assessments, and scale of penetration/aspiration, although the values were not statistically significant. Statistically significant correlation was observed between clinical and objective assessments and the penetration scale, with the largest occurring between the results of objective assessment and penetration scale. There was a correlation between clinical and objective assessments of swallowing and mean difference between the variables of the reason for the referral with their respective assessment. This shows the importance of the association between the data of patient's history and results of clinical evaluation and complementary tests, such as videofluoroscopy, for correct identification of the swallowing disorders, being important to combine the use of severity scales of penetration/aspiration for diagnosis.

  13. Quantifying risk of early relapse in patients with first demyelinating events: Prediction in clinical practice.

    PubMed

    Spelman, Tim; Meyniel, Claire; Rojas, Juan Ignacio; Lugaresi, Alessandra; Izquierdo, Guillermo; Grand'Maison, Francois; Boz, Cavit; Alroughani, Raed; Havrdova, Eva; Horakova, Dana; Iuliano, Gerardo; Duquette, Pierre; Terzi, Murat; Grammond, Pierre; Hupperts, Raymond; Lechner-Scott, Jeannette; Oreja-Guevara, Celia; Pucci, Eugenio; Verheul, Freek; Fiol, Marcela; Van Pesch, Vincent; Cristiano, Edgardo; Petersen, Thor; Moore, Fraser; Kalincik, Tomas; Jokubaitis, Vilija; Trojano, Maria; Butzkueven, Helmut

    2017-09-01

    Characteristics at clinically isolated syndrome (CIS) examination assist in identification of patient at highest risk of early second attack and could benefit the most from early disease-modifying drugs (DMDs). To examine determinants of second attack and validate a prognostic nomogram for individualised risk assessment of clinical conversion. Patients with CIS were prospectively followed up in the MSBase Incident Study. Predictors of clinical conversion were analysed using Cox proportional hazards regression. Prognostic nomograms were derived to calculate conversion probability and validated using concordance indices. A total of 3296 patients from 50 clinics in 22 countries were followed up for a median (inter-quartile range (IQR)) of 1.92 years (0.90, 3.71). In all, 1953 (59.3%) patients recorded a second attack. Higher Expanded Disability Status Scale (EDSS) at baseline, first symptom location, oligoclonal bands and various brain and spinal magnetic resonance imaging (MRI) metrics were all predictors of conversion. Conversely, older age and DMD exposure post-CIS were associated with reduced rates. Prognostic nomograms demonstrated high concordance between estimated and observed conversion probabilities. This multinational study shows that age at CIS onset, DMD exposure, EDSS, multiple brain and spinal MRI criteria and oligoclonal bands are associated with shorter time to relapse. Nomogram assessment may be useful in clinical practice for estimating future clinical conversion.

  14. 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.

  15. Screening for violence risk in military veterans: predictive validity of a brief clinical tool.

    PubMed

    Elbogen, Eric B; Cueva, Michelle; Wagner, H Ryan; Sreenivasan, Shoba; Brancu, Mira; Beckham, Jean C; Van Male, Lynn

    2014-07-01

    Violence toward others is a serious problem among a subset of military veterans. The authors evaluated the predictive validity of a brief decision support tool to screen veterans for problems with violence and identify potential candidates for a comprehensive risk assessment. Data on risk factors at an initial wave and on violent behavior at 1-year follow-up were collected in two independent sampling frames: a national random-sample survey of 1,090 Iraq and Afghanistan veterans and in-depth assessments of 197 dyads of veterans and collateral informants. Risk factors (lacking money for basic needs, combat experience, alcohol misuse, history of violence and arrests, and anger associated with posttraumatic stress disorder) were chosen based on empirical support in published research. Scales measuring these risk factors were examined, and items with the most robust statistical association with outcomes were selected for the screening tool. Regression analyses were used to derive receiver operating characteristic curves of sensitivities and specificities, with area under the curve providing an index of predictive validity. The resultant 5-item screening tool, called the Violence Screening and Assessment of Needs (VIO-SCAN), yielded area-under-the-curve statistics ranging from 0.74 to 0.78 for the national survey and from 0.74 to 0.80 for the in-depth assessments, depending on level of violence analyzed. Although the VIO-SCAN does not constitute a comprehensive violence risk assessment and cannot replace fully informed clinical decision making, it is hoped that the screen will provide clinicians with a rapid, systematic method for identifying veterans at higher risk of violence, prioritizing those in need a full clinical workup, structuring review of empirically supported risk factors, and developing plans collaboratively with veterans to reduce risk and increase successful reintegration in the community.

  16. Clinical trial registration was not an indicator for low risk of bias.

    PubMed

    Farquhar, Cynthia M; Showell, Marian G; Showell, Emily A E; Beetham, Penny; Baak, Nora; Mourad, Selma; Jordan, Vanessa M B

    2017-04-01

    To determine the prevalence of registered trials and to evaluate the risk of bias between registered and unregistered clinical trials. The Cochrane Gynecology and Fertility Group's specialized register was searched on November 5, 2015, for randomized controlled trials published from 2010 to 2014. Studies were selected if they had randomized women or men for fertility treatments, were published in full text and written in English. Two reviewers then independently assessed trial registration status for each trial, by searching the publication, trial registries, and by contacting the original authors. Of 693 eligible randomized controlled trials, only 44% were found to be registered. Unregistered clinical trials had smaller sample sizes than registered trials (P < 0.001). A random subsample of 125 registered and 125 unregistered trials was assessed for risk of bias using five of the Cochrane Risk of Bias "domains." Registered and unregistered trials differed in their risk of bias for random sequence generation (P = 0.001), allocation concealment (P = 0.003), and selective reporting (P < 0.001) but not blinding or incomplete outcome data (P > 0.05) domains. Only 54 (43.2%) of the 125 registered trials were registered prospectively. This study has the following limitations. Only English language trials were included in this review. We were unable to obtain protocols for the unregistered trials and therefore were unable to assess the risk of bias in the selective reporting domain. All available trials should be included in systematic reviews and assessed for risk of bias as there are both registered trials with high risk of bias and unregistered trials with low risk of bias and by excluding unregistered trials more than half of the available evidence will be lost. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. 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.

  18. Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit.

    PubMed

    Bonfant, Giovanna; Belfanti, Pietro; Paternoster, Giuseppe; Gabrielli, Danila; Gaiter, Alberto M; Manes, Massimo; Molino, Andrea; Pellu, Valentina; Ponzetti, Clemente; Farina, Massimo; Nebiolo, Pier E

    2010-01-01

    The aim of clinical risk management is to improve the quality of care provided by health care organizations and to assure patients' safety. Failure mode and effect analysis (FMEA) is a tool employed for clinical risk reduction. We applied FMEA to chronic hemodialysis outpatients. FMEA steps: (i) process study: we recorded phases and activities. (ii) Hazard analysis: we listed activity-related failure modes and their effects; described control measures; assigned severity, occurrence and detection scores for each failure mode and calculated the risk priority numbers (RPNs) by multiplying the 3 scores. Total RPN is calculated by adding single failure mode RPN. (iii) Planning: we performed a RPNs prioritization on a priority matrix taking into account the 3 scores, and we analyzed failure modes causes, made recommendations and planned new control measures. (iv) Monitoring: after failure mode elimination or reduction, we compared the resulting RPN with the previous one. Our failure modes with the highest RPN came from communication and organization problems. Two tools have been created to ameliorate information flow: "dialysis agenda" software and nursing datasheets. We scheduled nephrological examinations, and we changed both medical and nursing organization. Total RPN value decreased from 892 to 815 (8.6%) after reorganization. Employing FMEA, we worked on a few critical activities, and we reduced patients' clinical risk. A priority matrix also takes into account the weight of the control measures: we believe this evaluation is quick, because of simple priority selection, and that it decreases action times.

  19. Sub-clinical psychosis symptoms in young adults are risk factors for subsequent common mental disorders.

    PubMed

    Rössler, Wulf; Hengartner, Michael P; Ajdacic-Gross, Vladeta; Haker, Helene; Gamma, Alex; Angst, Jules

    2011-09-01

    Not all persons identified in the early stages to be at risk for psychosis eventually cross the threshold for a psychotic illness. However, sub-clinical symptoms may not only indicate a specific risk but also suggest a more general, underlying psychopathology that predisposes one to various common mental disorders. Analyzing data from the prospective Zurich Cohort Study, we used two psychosis subscales - "schizotypal signs" and "schizophrenia nuclear symptoms" - derived from the SCL-90-R checklist that measured sub-clinical psychosis symptoms in 1979. We also assessed 10 different diagnoses of common mental disorders through seven interview waves between 1979 and 2008. This 30-year span, covering participant ages of 19/20 to 49/50, encompasses the period of highest risk for the occurrence of such disorders. Both psychosis scales from 1979, but especially "schizotypal signs", were significantly correlated with most mental disorders over the subsequent test period. Higher values on both subscales were associated with an increasing number of co-occurring disorders. Our data demonstrate that sub-clinical psychosis generally represents a risk factor for the development of common mental disorders and a liability for co-occurring disorders. This refers in particular to dysthymia, bipolar disorder, social phobia, and obsessive-compulsive disorder. Proneness to psychosis could signal a fundamental tendency toward common mental disorders. Copyright © 2011 Elsevier B.V. All rights reserved.

  20. Smoldering multiple myeloma: pathophysiologic insights, novel diagnostics, clinical risk models, and treatment strategies.

    PubMed

    Kazandjian, Dickran; Mailankody, Sham; Korde, Neha; Landgren, Ola

    2014-09-01

    Smoldering multiple myeloma (SMM) is a plasma cell disorder first described in 1980 when 6 patients were observed to meet the diagnostic criteria of multiple myeloma, defined as bone marrow plasmacytosis of 10% or greater or M protein level of 3 g/dL or greater, but did not have end-organ damage. Subsequent studies showed that the cumulative risk of SMM progression to symptomatic myeloma in 15 years was 73%. Since this time, advances have been made in understanding the biology of progression; namely, the contribution of branching evolution and microenvironment models to clonal heterogeneity. In parallel to this, clinical risk models using standard platforms of serum, bone marrow, and fluorescence in situ hybridization markers along with newer technologies of flow cytometry, gene expression profiling, and magnetic resonance imaging have been developed for prognostic stratification. Treatment has extended to the early myeloma category owing to more sensitive diagnostic approaches. The development of novel treatments will have to take into consideration our current knowledge of biological transformation. While it may be attractive to initiate early treatment in light of recent studies for high-risk SMM patients, clinical trial evidence of efficacy vs toxicity is still in its infancy. In our opinion, high-risk SMM patients should be strongly encouraged to enroll in treatment clinical trials, but treatment with unapproved agents or indications is not supported outside of trials.

  1. An analytics based clinical decision support system for CVD risk assessment and management.

    PubMed

    Anand, Shreya; Patil, Ravindra B; Krishnamoorthy, P

    2016-08-01

    Cardiovascular disease (CVD) is a major cause of disability and premature death throughout the world. Acute coronary events and other cardiovascular events frequently occur suddenly, and are often fatal before medical care can be given. Risk factor modification can reduce clinical events and premature death in people with established cardiovascular disease as well as in those who are at high cardiovascular risk due to one or more risk factors. In this work, India specific World Health Organization-International Society of Hypertension (WHO-ISH) guidelines has been implemented to stratify the subjects by their risk profile. It provides simplified approach to detect those people at high risk and provides guidance on what should be done for prevention of heart attack. Further, based on the risk stratification, lifestyle coaching, medication management and the next tests are advised to the subjects. This approach will help in early detection of cardiovascular risk subjects and provide necessary interventions at appropriate time frame. Also, it acts as motivation to the individuals to comply with recommended lifestyle changes.

  2. A counterfactual p-value approach for benefit-risk assessment in clinical trials.

    PubMed

    Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

    2015-01-01

    Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

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

    PubMed

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

    2015-01-01

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

  4. 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

  5. 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

  6. Clinical and neurophysiological risk factors for falls in patients with bilateral vestibulopathy.

    PubMed

    Schniepp, Roman; Schlick, Cornelia; Schenkel, Fabian; Pradhan, Cauchy; Jahn, Klaus; Brandt, Thomas; Wuehr, Max

    2017-02-01

    Patients with bilateral vestibular failure (BVF) exhibit imbalance when standing and walking that is linked to a higher fall risk. The purpose of this study was to identify risk factors for falls in BVF. We therefore systematically investigated the interrelationship of clinical and demographic characteristics, gait impairments, and the fall frequency of these patients. Clinical and demographic characteristics as well as quantitative measures of gait performance on a pressure-sensitive gait carpet were collected from 55 patients with different etiologies of BVF. Clinical and demographic data as well as spatiotemporal gait characteristics were used for ANOVA testing and a logistic regression model with categorized fall events as dependent variables. The impairment of peripheral vestibular function, duration of disease, and the overall gait status were not associated with the history of falls in patients with BVF. In contrast, the most predictive factors for falls in BVF were an increase in temporal gait variability, especially at slow walking speeds (p < 0.001; OR = 1.3), and the presence of a concomitant peripheral neuropathy (p < 0.045; OR = 3.6). BVF patients with a high risk of falling exhibit specific gait alterations in a speed-dependent manner. In particular, increased gait fluctuations during slow walking are most predictive for an increased fall risk. The presence of a concomitant peripheral neuropathy further critically impairs postural stability in these patients. Clinical assessment of both these aspects is therefore important to identify those patients at a particularly high fall risk and to initiate preventive procedures early.

  7. Effects of socioeconomic position and clinical risk factors on spontaneous and iatrogenic preterm birth.

    PubMed

    Joseph, K S; Fahey, John; Shankardass, Ketan; Allen, Victoria M; O'Campo, Patricia; Dodds, Linda; Liston, Robert M; Allen, Alexander C

    2014-03-27

    The literature shows a variable and inconsistent relationship between socioeconomic position and preterm birth. We examined risk factors for spontaneous and iatrogenic preterm birth, with a focus on socioeconomic position and clinical risk factors, in order to explain the observed inconsistency. We carried out a retrospective population-based cohort study of all singleton deliveries in Nova Scotia from 1988 to 2003. Data were obtained from the Nova Scotia Atlee Perinatal Database and the federal income tax T1 Family Files. Separate logistic models were used to quantify the association between socioeconomic position, clinical risk factors and spontaneous preterm birth and iatrogenic preterm birth. The study population included 132,714 singleton deliveries and the rate of preterm birth was 5.5%. Preterm birth rates were significantly higher among the women in the lowest (versus the highest) family income group for spontaneous (rate ratio 1.14, 95% confidence interval (CI) 1.03, 1.25) but not iatrogenic preterm birth (rate ratio 0.95, 95% CI 0.75, 1.19). Adjustment for maternal characteristics attenuated the family income-spontaneous preterm birth relationship but strengthened the relationship with iatrogenic preterm birth. Clinical risk factors such as hypertension were differentially associated with spontaneous (rate ratio 3.92, 95% CI 3.47, 4.44) and iatrogenic preterm (rate ratio 14.1, 95% CI 11.4, 17.4) but factors such as diabetes mellitus were not (rate ratio 4.38, 95% CI 3.21, 5.99 for spontaneous and 4.02, 95% CI 2.07, 7.80 for iatrogenic preterm birth). Socioeconomic position and clinical risk factors have different effects on spontaneous and iatrogenic preterm. Recent temporal increases in iatrogenic preterm birth appear to be responsible for the inconsistent relationship between socioeconomic position and preterm birth.

  8. Prevalence, risk factors and clinical signs predictive for equine pituitary pars intermedia dysfunction in aged horses.

    PubMed

    McGowan, T W; Pinchbeck, G P; McGowan, C M

    2013-01-01

    Equine pituitary pars intermedia dysfunction (PPID) is an ageing-related neurodegenerative disorder. The prevalence and risk factors for PPID using seasonally adjusted basal adrenocorticotropic hormone (ACTH) concentrations in aged horses have not been previously reported. To determine the prevalence, risk factors and clinical signs predictive for PPID in a population of horses aged ≥ 15 years in Queensland, Australia. Owner-reported data was obtained using a postal questionnaire distributed to an equestrian group. A subgroup of surveyed owners were visited and a veterinary physical examination performed on all horses aged ≥ 15 years. Blood samples were analysed for basal plasma alpha melanocyte-stimulating hormone (α-MSH) and ACTH concentrations, routine haematology and selected biochemistry. Aged horses with elevations above seasonally adjusted cut-off values for basal plasma ACTH were considered positive for PPID. Positive horses were compared with their aged counterparts to determine risk factors and clinical signs associated with PPID. Pituitary pars intermedia dysfunction was prevalent in aged horses (21.2%) despite owners infrequently reporting it as a known or diagnosed disease or disorder. Numerous clinical or historical signs were associated with an increased risk of PPID in the univariable model, but only age (odds ratio (OR) 1.18; 95% confidence interval (CI) 1.11-1.25, P<0.001) and owner-reported history of hirsutism (OR 7.80; 95% CI 3.67-16.57, P<0.001) remained in the final multivariable model. There were no routine haematological or biochemical variables supportive of a diagnosis of PPID. Pituitary pars intermedia dysfunction occurs commonly in aged horses despite under-recognition by owners. The increased risk of PPID with age supports that this is an ageing associated condition. Aged horses with clinical or historical signs consistent with PPID, especially owner-reported hirsutism (delayed shedding and/or long hair coat), should be tested and

  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.

  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. Correspondence between Psychometric and Clinical High Risk for Psychosis in an Undergraduate Population

    PubMed Central

    Cicero, David C.; Martin, Elizabeth A.; Becker, Theresa M.; Docherty, Anna; Kerns, John G.

    2014-01-01

    Despite the common use of either psychometric or clinical methods for identifying individuals at risk for psychosis, previous research has not examined the correspondence and extent of convergence of these two approaches. Undergraduates (n = 160), selected from a larger pool, completed three self-report schizotypy scales, the Magical Ideation Scale, the Perceptual Aberration Scale, and the Revised Social Anhedonia Scale, and were administered the Structured Interview for Prodromal Syndromes (SIPS). First, high correlations were observed for self-report and interview-rated psychotic like experiences (rs between .48 and .61, p < .001). Second, 77 percent of individuals identified as having a risk for psychosis with the self-report measures reported at least one clinically meaningful psychotic-like experience on the SIPS. Third, receiver operating characteristic curve analyses showed that the self-report scales can be used to identify which participants report clinically meaningful positive symptoms. These results suggest that mostly white undergraduate participants identified as at risk with the psychometric schizotypy approach report clinically meaningful psychotic-like experiences in an interview format and that the schizotypy scales are moderately to strongly correlated with interview-rated psychotic-like experiences. The results of the current research provide a baseline for comparing research between these two approaches. PMID:24708081

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

    PubMed

    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%).

  13. Using Clinical Classification Trees to Identify Individuals At Risk of STDs During Pregnancy

    PubMed Central

    Kershaw, Trace S.; Lewis, Jessica; Westdahl, Claire; Wang, Yun F.; Rising, Sharon Schindler; Massey, Zohar; Ickovics, Jeannette

    2008-01-01

    CONTEXT Few studies have used classification tree analysis to produce empirically driven decision tools that identify subgroups of women at risk of STDs during pregnancy. Such tools can guide care, treatment and prevention efforts in clinical settings. METHODS A sample of 647 women aged 14−25 attending two urban obstetrics and gynecology clinics in 2001−2004 were surveyed in their second and third trimesters. Baseline predictors at the individual, dyad, and family and community levels were used to develop a classification tree that differentiated subgroups of women by STD incidence at 35 weeks' gestation. Logistic regression analyses were conducted to assess whether the classification tree groups or commonly used risk factors better predicted STD incidence. RESULTS Nineteen percent of women had an incident STD during pregnancy. Classification tree analysis identified three subgroups with a high STD incidence (33−61%), one with a moderate incidence (16%) and three with a low incidence (6−11%). Women in subgroups with high STD incidence included those not living with the partner with whom they conceived and those who had a moderate or a high level of depression, a history of STDs and a low level of social support. A logistic regression model using groups defined by the classification tree analysis had better predictive ability than one using common demographic and sexual risk predictors. CONCLUSION This classification tree identified risk factors not captured by traditional risk screenings, and could be used to guide STD treatment, care and prevention within the prenatal care setting. PMID:17845525

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

    PubMed Central

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

    2013-01-01

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

  15. Genetic and clinical risk factors for fluid overload following open-heart surgery.

    PubMed

    Enger, T B; Pleym, H; Stenseth, R; Wahba, A; Videm, V

    2014-05-01

    Post-operative fluid overload following cardiac surgery is associated with increased morbidity and mortality. We hypothesised that genetic variations and pre-operative clinical factors predispose some patients to post-operative fluid overload. Perioperative variables were collected prospectively for 1026 consecutive adults undergoing open-heart surgery at St. Olavs University Hospital, Norway from 2008-2010. Post-operative fluid overload was defined as a post-operative fluid balance/kg ≥ the 90th percentile of the study population. Genotyping was performed for 31 single-nucleotide polymorphisms related to inflammatory/vascular responses or previously associated with complications following open-heart surgery. Data were analysed using logistic regression modelling, and the findings were internally validated by bootstrapping (n = 100). Homozygous carriers of the common G allele of rs12917707 in the UMOD gene had a 2.2 times greater risk of post-operative fluid overload (P = 0.005) after adjustment for significant clinical variables (age, duration of cardiopulmonary bypass, and intraoperative red cell transfusion). A genetic risk score including 14 single-nucleotide polymorphisms was independently associated with post-operative fluid overload (P = 0.001). The number of risk alleles was linearly associated with the frequency of fluid overload (odds ratio per risk allele 1.153, 95 % confidence interval 1.056-1.258). Nagelkerke's R(2) increased with 7.5% to a total of 25% for the combined clinical and genetic model. Hemofiltration did not reduce the risk. A common variation in the UMOD gene previously shown to be related to renal function was associated with increased risk of post-operative fluid overload following cardiac surgery. Our findings support a genetic susceptibility to disturbed fluid handling following cardiac surgery. © 2014 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  16. 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

  17. Reconsidering Clinical Staging Model: A Case of Genetic High Risk for Schizophrenia

    PubMed Central

    Lee, Tae Young; Kim, Minah; Kim, Sung Nyun

    2017-01-01

    The clinical staging model is considered a useful and practical method not only in dealing with the early stage of psychosis overcoming the debate about diagnostic boundaries but also in emerging mood disorder. However, its one limitation is that it cannot discriminate the heterogeneity of individuals at clinical high risk for psychosis, but lumps them all together. Even a healthy offspring of schizophrenia can eventually show clinical symptoms and progress to schizophrenia under the influence of genetic vulnerability and environmental stress even after the peak age of onset of schizophrenia. Therefore, individuals with genetic liability of schizophrenia may require a more intensive intervention than recommended by the staging model based on current clinical status. PMID:28096883

  18. Clinical Characteristics and Risk Factors of Extensive Macular Atrophy with Pseudodrusen: The EMAP Case-Control National Clinical Trial.

    PubMed

    Douillard, Aymeric; Picot, Marie-Christine; Delcourt, Cécile; Lacroux, Annie; Zanlonghi, Xavier; Puech, Bernard; Defoort-Dhelemmes, Sabine; Drumare, Isabelle; Jozefowicz, Elsa; Bocquet, Béatrice; Baudoin, Corinne; Al-Dain Marzouka, Nour; Perez-Roustit, Sarah; Arsène, Sophie; Gissot, Valérie; Devin, François; Arndt, Carl; Wolff, Benjamin; Mauget-Faÿsse, Martine; Quaranta, Maddalena; Mura, Thibault; Deplanque, Dominique; Oubraham, Hassiba; Cohen, Salomon Yves; Gastaud, Pierre; Zambrowsky, Olivia; Creuzot-Garcher, Catherine; Mohand Saïd, Saddek; Blanco Garavito, Rocio; Souied, Eric; Sahel, José-Alain; Audo, Isabelle; Hamel, Christian; Meunier, Isabelle

    2016-09-01

    To assess the association of clinical and biological factors with extensive macular atrophy with pseudodrusen (EMAP) characterized by bilateral macular atrophy occurring in patients aged 50 to 60 years and a rapid progression to legal blindness within 5 to 10 years. A national matched case-control study. Participants were recruited in 10 French Departments of Ophthalmology and their associated clinical investigation centers. All 115 patients with EMAP had symptoms before the age of 55 years due to bilateral extensive macular atrophy with a larger vertical axis and diffuse pseudodrusen. Three controls without age-related macular degeneration (AMD) or retinal disease at fundus examination were matched for each patient with EMAP by gender, age, and geographic area (in total 415). Subjects and controls underwent an eye examination including color, red-free autofluorescent fundus photographs and spectral-domain optical coherence tomography with macular analysis. The interviews collected demographic, lifestyle, family and personal medical history, medications, and biological data. Associations of risk factors were estimated using conditional logistic regression. Extensive macular atrophy with pseudodrusen status (cases vs. controls). Extensive macular atrophy with pseudodrusen most frequently affected women (70 women, 45 men). After multivariate adjustment, family history of glaucoma or AMD was strongly associated with EMAP (odds ratio [OR], 2.3, P = 0.008 and OR, 1.5, P = 0.01, respectively). No association was found with cardiac diseases or their risk factors. Mild and moderate kidney disease and higher neutrophil rate were associated with a reduced risk of EMAP (OR, 0.58, P = 0.04; OR, 0.34, P = 0.01; and OR, 0.59, P = 0.003, respectively). On the contrary, eosinophilia (OR, 1.6; P = 0.0002), lymphocytosis (OR, 1.84; P = 0.0002), increased erythrocyte sedimentation rate (OR, 6.5; P = 0.0005), decreased CH50 (P = 0.001), and high plasma C3 level (P = 0

  19. Vitamin E and risk of cardiovascular diseases: a review of epidemiologic and clinical trial studies.

    PubMed

    Cordero, Zorabel; Drogan, Dagmar; Weikert, Cornelia; Boeing, Heiner

    2010-05-01

    Cardiovascular diseases are the leading cause of worldwide mortality. There is strong epidemiologic evidence for a beneficial effect of vitamin E on cardiovascular disease risk. However, conflicting results have been reported by intervention studies. To assess the potential benefit of vitamin E intake on the risk of cardiovascular diseases, fifty-nine published reports from observational studies, retrospective and prospective, randomised clinical trials, meta-analyses as well as pooling analyses were reviewed. The paper provides a detailed discussion about design, quality and limitations of these studies with regard to the evidence of the hypothesized relationship between vitamin E and cardiovascular diseases.

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

    PubMed

    Davis, Jaya; Sorensen, Jon R

    2013-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  2. Stage IV Gastro-Entero-Pancreatic Neuroendocrine Neoplasms: A Risk Score to Predict Clinical Outcome.

    PubMed

    Panzuto, Francesco; Merola, Elettra; Pavel, Marianne Ellen; Rinke, Anja; Kump, Patrizia; Partelli, Stefano; Rinzivillo, Maria; Rodriguez-Laval, Victor; Pape, Ulrich Frank; Lipp, Rainer; Gress, Thomas; Wiedenmann, Bertram; Falconi, Massimo; Delle Fave, Gianfranco

    2017-04-01

    Several risk factors predict clinical outcome in gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NENs); however, the impact of their combination has not been investigated so far. A retrospective analysis of stage IV GEP-NENs was performed. Multivariate analysis for progression of disease (PD) was performed by Cox proportional hazards method to obtain a risk score. Area under the curve obtained by receiver operating characteristic analysis was used to assess the score performance. Progression-free survival analysis was performed by Kaplan-Meier method. Two hundred eighty-three stage IV GEP-NENs were evaluated, including 93 grade 1 neuroendocrine tumors (32.9%), 153 grade 2 neuroendocrine tumors (54%), and 37 grade 3 neuroendocrine carcinomas (13.1%). Independent risk factors for PD were Ki67, proportion of metastatic liver involvement, and presence of extra-abdominal metastases. The risk score was calculated as follows: (0.025 × Ki67) + [(0 if no liver metastases or liver involvement <25%) OR (0.405 if liver involvement 25%-50%) OR (0.462 if liver involvement >50%)] + [(0 if no extra-abdominal metastases) OR (0.528 if extra-abdominal metastases present)]. The risk score accuracy to predict PD was superior compared with the G grading system (area under the curve: 0.705 and 0.622, respectively). Three subgroups of patients with low, intermediate, and high risk of PD according to risk score were identified, median progression-free survival being 26 months, 19 months, and 12 months, respectively. In stage IV GEP-NENs, a risk score able to predict PD was obtained by combining Ki67, proportion of metastatic liver involvement, and presence of extra-abdominal metastases. The score may help to discriminate patients with different progression risk level to plan tailored therapeutic approaches and follow-up programs. The Oncologist 2017;22:409-415Implications for Practice: Clinical outcome of patients with advanced gastro-entero-pancreatic neuroendocrine

  3. Clinically relevant heterotopic ossification after elbow fracture surgery: a risk factors study.

    PubMed

    Hong, C C; Nashi, N; Hey, H W; Chee, Y H; Murphy, D

    2015-04-01

    Heterotopic ossification (HO) is a common complication of elbow fracture surgery that can significantly impair function and range of motion (ROM). Whereas numerous studies have assessed HO after hip trauma or replacement surgery, few data have been reported on the prevalence and risk factors of HO after elbow fractures. Our objective was to investigate the prevalence and risk factors of clinically relevant HO after elbow fracture surgery under the hypothesis that the ability to identify high-risk patients would improve treatment tailoring and assist in meeting patient expectations. We retrospectively included consecutive patients who had surgery for elbow injuries between January 2007 and December 2011. Patient demographics, operative details, and radiographs were reviewed. Of 124 elbows in 122 patients, 38 (30.6%) had HO and 26 (21%) clinically relevant HO. The prevalence of clinically relevant HO was highest in floating elbow injury, followed by combined olecranon and radial head fractures, types A and B distal humerus fractures, and terrible triad injury. By multiple logistic regression, factors that independently predicted clinically relevant HO were fracture-dislocation (OR, 4.87; 95%CI, 1.78-13.29; P=0.002) and longer time to surgery (P<0.05). Of the 26 patients with clinically relevant HO, 6 (23%) eventually required revision elbow surgery to improve ROM. HO of the elbow occurred in almost one-third of our patients with surgically treated elbow fractures. Fracture-dislocation of the elbow and longer time to surgery independently predicted HO responsible for ROM loss. Clinically relevant HO was associated with significant morbidity. Level IV, retrospective study. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  4. How to Identify High-Risk APS Patients: Clinical Utility and Predictive Values of Validated Scores.

    PubMed

    Oku, Kenji; Amengual, Olga; Yasuda, Shinsuke; Atsumi, Tatsuya

    2017-08-01

    Antiphospholipid syndrome (APS) is a clinical disorder characterised by thrombosis and/or pregnancy morbidity in the persistence of antiphospholipid (aPL) antibodies that are pathogenic and have pro-coagulant activities. Thrombosis in APS tends to recur and require prophylaxis; however, the stereotypical treatment for APS patients is inadequate and stratification of the thrombotic risks is important as aPL are prevalently observed in various diseases or elderly population. It is previously known that the multiple positive aPL or high titre aPL correlate to thrombotic events. To progress the stratification of thrombotic risks in APS patients and to quantitatively analyse those risks, antiphospholipid score (aPL-S) and the Global Anti-phospholipid Syndrome Score (GAPSS) were defined. These scores were raised from the large patient cohort data and either aPL profile classified in detail (aPL-S) or simplified aPL profile with classical thrombotic risk factors (GAPSS) was put into a scoring system. Both the aPL-S and GAPSS have shown a degree of accuracy in identifying high-risk APS patients, especially those at a high risk of thrombosis. However, there are several areas requiring improvement, or at least that clinicians should be aware of, before these instruments are applied in clinical practice. One such issue is standardisation of the aPL tests, including general testing of phosphatidylserine-dependent antiprothrombin antibodies (aPS/PT). Additionally, clinicians may need to be aware of the patient's medical history, particularly with respect to the incidence of SLE, which influences the cutoff value for identifying high-risk patients.

  5. Clinical measures, smoking, radon exposure, and risk of lung cancer in uranium miners.

    PubMed Central

    Finkelstein, M M

    1996-01-01

    OBJECTIVES: Exposure to the radioactive daughters of radon is associated with increased risk of lung cancer in mining populations. An investigation of incidence of lung cancer following a clinical survey of Ontario uranium miners was undertaken to explore whether risk associated with radon is modified by factors including smoking, radiographic silicosis, clinical symptoms, the results of lung function testing, and the temporal pattern of radon exposure. METHODS: Miners were examined in 1974 by a respiratory questionnaire, tests of lung function, and chest radiography. A random selection of 733 (75%) of the original 973 participants was followed up by linkage to the Ontario Mortality and Cancer Registries. RESULTS: Incidence of lung cancer was increased threefold. Risk of lung cancer among miners who had stopped smoking was half that of men who continued to smoke. There was no interaction between smoking and radon exposure. Men with lung function test results consistent with airways obstruction had an increased risk of lung cancer, even after adjustment for cigarette smoking. There was no association between radiographic silicosis and risk of lung cancer. Lung cancer was associated with exposures to radon daughters accumulated in a time window four to 14 years before diagnosis, but there was little association with exposures incurred earlier than 14 years before diagnosis. Among the men diagnosed with lung cancer, the mean and median dose rates were 2.6 working level months (WLM) a year and 1.8 WLM/year in the four to 14 year exposure window. CONCLUSIONS: Risk of lung cancer associated with radon is modified by dose and time from exposure. Risk can be substantially decreased by stopping smoking. PMID:8943835

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

    PubMed

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

    2015-11-01

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

  7. Screening for Violence Risk in Military Veterans: Predictive Validity of a Brief Clinical Tool

    PubMed Central

    Elbogen, Eric B.; Cueva, Michelle; Wagner, H. Ryan; Sreenivasan, Shoba; Brancu, Mira; Beckham, Jean C.; Van Male, Lynn

    2014-01-01

    Objective Violence toward others is a serious problem among a subset of military veterans. This study reports on predictive validity of a brief screening tool for violence in veterans. Methods Data on risk factors at an initial wave and on violent behavior at 1-year follow-up were collected in two independent sampling frames: (a) a national random sample survey of 1090 Iraq and Afghanistan veterans, and (b) in-depth assessments of 197 dyads of Iraq and Afghanistan veterans and collateral informants. Results We chose candidate risk factors—financial instability, combat experience, alcohol misuse, history of violence and arrests, and anger associated with posttraumatic stress disorder (PTSD)—based on empirical support in published research. Tools measuring these risk factors were examined, and items with the most robust statistical association to outcomes were selected. The resultant 5-item clinical tool, the Violence Screening and Assessment of Needs (VIO-SCAN), yielded area under the curve (AUC) statistics ranging from .74 – .78 for the national survey and from .74 – .80 for the in-depth assessments, depending on level of violence analyzed using multiple logistic regression. Conclusions To our knowledge, the VIO-SCAN is the first empirically-derived assessment tool for violence developed specifically for military veteran populations. As in civilians, past violence and arrest history had a robust association with future violence in veterans. Analyses show that individual factors examined in isolation (e.g., PTSD, combat experience) do not adequately convey a veteran’s level of violence risk; rather, as shown by the VIO-SCAN, multiple risk factors need to be taken into account in tandem when assessing risk in veterans. Use of evidence-based methods for assessing and managing violence in veterans is discussed, addressing benefits and limits of integrating risk assessment tools into clinical practice. PMID:24832765

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

    PubMed

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

    2009-05-15

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

  9. Risk assessment with actuarial and clinical methods: Measurement and evidence-based practice.

    PubMed

    Mendoza, Natasha S; Rose, Roderick A; Geiger, Jennifer M; Cash, Scottye J

    2016-11-01

    Child welfare agencies have adopted assessment tools and instruments to inform the level of risk and guide the agency's level of intervention with the family. Actuarial assessments may be more uniform but inflexible with respect to practice wisdom whereas clinical or consensus-based assessments are more comprehensive and intuitive but lack objectivity. The purpose of the current study is to compare clinical and actuarial methods of risk assessment used by child welfare workers to make decisions about substantiation and services. The current study examined the (1) association between clinical and actuarial dimensions, (2) association between actuarial dimensions and outcomes, (3) association between clinical dimensions and outcomes, (4) caseworker primary use of actuarial dimensions, and (5) caseworker supplementary use of actuarial dimensions. Findings indicated that the actuarial may not be solely predictive of agency intensity with respect to case decision and service provision. Our findings suggest that dual-measurement does inform intensity, and we speculate from these findings that the measures may be involved with decision-making in a complex way. This study may be best viewed as a means by which researchers begin to parse how decisions are made; with this information, instruments may be better tailored to facilitate clinical, critical thought. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. 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

  11. 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

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

    PubMed

    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

    2016-04-01

    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. 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. 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). Our findings provide clues to better understand the pathogenesis of gout and will be useful for development of companion diagnostics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  13. Environmental Risk Assessment of Clinical Trials Involving Modified Vaccinia Virus Ankara (MVA)-Based Vectors

    PubMed Central

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

    2013-01-01

    The modified vaccinia virus Ankara (MVA) strain, which has been developed as a vaccine against smallpox, is since the nineties widely tested in clinical trials as recombinant vector for vaccination or gene therapy applications. Although MVA is renowned for its safety, several biosafety aspects need to be considered when performing the risk assessment of a recombinant MVA (rMVA). This paper presents the biosafety issues and the main lessons learned from the evaluation of the clinical trials with rMVA performed in Belgium. Factors such as the specific characteristics of the rMVA, the inserted foreign sequences/transgene, its ability for reconversion, recombination and dissemination in the population and the environment are the main points of attention. Measures to prevent or manage identified risks are also discussed. PMID:24397528

  14. Investigating the connections between health lean management and clinical risk management.

    PubMed

    Crema, Maria; Verbano, Chiara

    2015-01-01

    The purpose of this paper is to investigate connections and overlaps between health lean management (HLM) and clinical risk management (CRM) understanding whether and how these two approaches can be combined together to pursue efficiency and patient safety improvements simultaneously. A systematic literature review has been carried out. Searching in academic databases, papers that focus not only on HLM, but also on clinical errors and risk reduction, were included. The general characteristics of the selected papers were analysed and a content analysis was conducted. In most of the papers, pursing objectives of HLM and CRM and adopting tools and practices of both approaches, results of quality and, particularly, of safety improvements were obtained. A two-way arrow between HLM and CRM emerged but so far, none of the studies has been focused on the relationship between HLM and CRM. Results highlight an emerging research stream, with many useful theoretical and practical implications and opportunities for further research.

  15. Early Detection of Psychosis: Recent Updates from Clinical High-Risk Research

    PubMed Central

    Schvarcz, Ariel

    2015-01-01

    The debilitating nature of schizophrenia necessitates early detection of individuals at clinical high-risk (CHR) in order to facilitate early intervention. In particular, comparisons between those who develop fully psychotic features (CHR+) and those who do not (CHR−) offer the opportunity to reveal distinct risk factors for psychosis, as well as possible intervention target points. Recent studies have investigated baseline clinical, neurocognitive, neuroanatomic, neurohormonal, and psychophysiological predictors of outcome; premorbid social dysfunction, deficits in neurocognitive performance, neuroanatomic changes, and hypothalamic-pituitary-adrenal (HPA) axis dysfunction have been implicated in psychosis emergence. However, several challenges within CHR research remain: heterogeneity in long-term diagnostic outcome, the variability of research tools and definitions utilized, and limited longitudinal follow-up. Future work in the field should focus on replication via extended longitudinal designs, aim to explore the trajectories and inter-relationships of hypothesized biomarkers, and continue to investigate interventions that seek to prevent psychosis emergence through symptom reduction. PMID:26693133

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

    PubMed

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

    2012-06-01

    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. 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. Community-based cohort of 125 homebound elderly individuals. 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. 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. 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.

  17. 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

  18. 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

  19. 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. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. 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.

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

    PubMed

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

    2015-03-18

    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. 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. 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. 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.

  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.

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

    PubMed

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

    2015-01-01

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

  4. 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.

  5. Clinical monitoring and high-risk conditions among patients with SUD newly prescribed opioids and benzodiazepines.

    PubMed

    Grossbard, Joel R; Malte, Carol A; Saxon, Andrew J; Hawkins, Eric J

    2014-09-01

    Opioid therapy alone or in combination with benzodiazepines poses safety concerns among patients with substance use disorders (SUD). Guidelines for opioid therapy recommend SUD treatment and enhanced monitoring, especially in patients with additional risk factors, but information on monitoring practices is sparse. This study estimated high-risk conditions - psychiatric comorbidity, suicide risk, and age <35 and ≥65 - and described clinical monitoring among patients with SUD who were newly prescribed opioids alone and concurrent with benzodiazepines long-term. This study included VA Northwest Veterans Network patients with SUD who started opioids only (n=980) or benzodiazepines and opioids concurrently (n=353) long-term (≥90 days) in 2009-2010. Clinical characteristics, outpatient visits and urine drug screens (UDS) documented within 7-months after starting medications were extracted from VA data. Approximately 67% (95% CI: 64-70) of opioids only and 94% (92-97) of concurrent medications groups had ≥1 psychiatric diagnoses. Prevalences of suicide risk and age <35 and ≥65 were 7% (5-8), 6% (5-8) and 18% (15-20) among the opioids only group, and 20% (16-24), 8% (5-11) and 13% (9-16) among the concurrent medications group. Among patients prescribed opioids only and medications concurrently, 87% and 91% attended primary care, whereas 28% and 26% attended SUD specialty-care. Overall, 30% and 48% of opioids only and concurrent medications groups engaged in mental health or SUD care, and 35% and 39% completed UDS. Improvements in clinical monitoring are needed as many VA patients with SUD and comorbid risks who initiate opioid therapy do not receive sufficient mental health/SUD care or UDS monitoring. Published by Elsevier Ireland Ltd.

  6. 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.

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

    PubMed

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

    2014-05-01

    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. 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. 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. 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. Copyright © 2014 Elsevier Inc. All rights reserved.

  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. Asthma and atopic dermatitis are associated with increased risk of clinical Plasmodium falciparum malaria

    PubMed Central

    Herrant, Magali; Loucoubar, Cheikh; Bassène, Hubert; Gonçalves, Bronner; Boufkhed, Sabah; Diene Sarr, Fatoumata; Fontanet, Arnaud; Tall, Adama; Baril, Laurence; Mercereau-Puijalon, Odile; Mécheri, Salaheddine; Sakuntabhai, Anavaj; Paul, Richard

    2013-01-01

    Objectives To assess the impact of atopy and allergy on the risk of clinical malaria. Design A clinical and immunological allergy cross-sectional survey in a birth cohort of 175 children from 1 month to 14 years of age followed for up to 15 years in a longitudinal open cohort study of malaria in Senegal. Malaria incidence data were available for 143 of these children (aged 4 months to 14 years of age) for up to 15 years. Mixed-model regression analysis was used to determine the impact of allergy status on malaria incidence, adjusting for age, gender, sickle-cell trait and force of infection. Main outcome measures Asthma, allergic rhinoconjunctivitis and atopic dermatitis status, the number of clinical Plasmodium falciparum malaria episodes since birth and associated parasite density. Results 12% of the children were classified as asthmatic and 10% as having atopic dermatitis. These groups had respectively a twofold (OR 2.12 95%; CI 1.46 to 3.08; p=8×10−5) and threefold (OR 3.15; 1.56 to 6.33; p=1.3×10−3) increase in the risk of clinical P falciparum malaria once older than the age of peak incidence of clinical malaria (3–4 years of age). They also presented with higher P falciparum parasite densities (asthma: mean 105.3 parasites/μL±SE 41.0 vs 51.3±9.7; p=6.2×10−3. Atopic dermatitis: 135.4±70.7 vs 52.3±11.0; p=0.014). There was no effect of allergy on the number of non-malaria clinical presentations. Individuals with allergic rhinoconjunctivitis did not have an increased risk of clinical malaria nor any difference in parasite densities. Conclusions These results demonstrate that asthma and atopic dermatitis delay the development of clinical immunity to P falciparum. Despite the encouraging decrease in malaria incidence rates in Africa, a significant concern is the extent to which the increase in allergy will exacerbate the burden of malaria. Given the demonstrated antiparasitic effect of antihistamines, administration to atopic

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

    PubMed Central

    Germolec, Dori R.; Luebke, Robert W.; Johnson, Victor J.

    2016-01-01

    This overview is an update of the unit originally published in 2004. While the basic 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 goal of this unit is still to highlight relationships between xenobiotic-induced immunosuppression and risk of clinical diseases progression. In immunotoxicology, this may require development of models to equate moderate changes in markers of immune functions to potential changes in incidence or severity of infectious diseases. For most xenobiotics, exposure levels and disease incidence data are rarely available and safe exposure levels must be estimated based on observations from experimental models or human biomarker studies. Thus, it is important to establish a scientifically sound framework that allows accurate and quantitative interpretation of experimental or biomarker data in the risk assessment process. PMID:26828330

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

    PubMed

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

    2016-02-01

    This overview is an update of the unit originally published in 2004. While the basic tenets of immunotoxicity have not changed in the past 10 years, several publications have explored the application of immunotoxicological data to the risk assessment process. Therefore, the goal of this unit is still to highlight relationships between xenobiotic-induced immunosuppression and risk of clinical diseases progression. In immunotoxicology, this may require development of models to equate moderate changes in markers of immune functions to potential changes in incidence or severity of infectious diseases. For most xenobiotics, exposure levels and disease incidence data are rarely available, and safe exposure levels must be estimated based on observations from experimental models or human biomarker studies. Thus, it is important to establish a scientifically sound framework that allows accurate and quantitative interpretation of experimental or biomarker data in the risk assessment process. Copyright © 2016 John Wiley & Sons, Inc.

  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. 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.

  14. The prevalence, risk factors and clinical correlates of obesity in Chinese patients with schizophrenia.

    PubMed

    Li, Qiongzhen; Du, Xiangdong; Zhang, Yingyang; Yin, Guangzhong; Zhang, Guangya; Walss-Bass, Consuelo; Quevedo, João; Soares, Jair C; Xia, Haishen; Li, Xiaosi; Zheng, Yingjun; Ning, Yuping; Zhang, Xiang Yang

    2017-05-01

    Obesity is a common comorbidity in schizophrenia. Few studies have addressed obesity in Chinese schizophrenia patients. The aims of this current study were to evaluate the prevalence, risk factors and clinical correlates of obesity in Chinese patients with schizophrenia. A total of 206 patients were recruited from a hospital in Beijing. Their clinical and anthropometric data together with plasma glucose and lipid parameters were collected. Positive and Negative Syndrome Scale (PANSS) was rated for all patients. Overall, 43 (20.9%) patients were obese and 67 (32.5%) were overweight. The obese patients had significantly higher glucose levels, triglyceride levels than non-obese patients. Females and patients with type 2 diabetes mellitus had increased risk for obesity. Correlation analysis showed that BMI was associated with sex, education levels, negative symptoms, total PANSS score, triglyceride levels and type 2 diabetes mellitus. Further stepwise regression analysis showed that sex, type 2 diabetes, education level, triglyceride and amount of smoking/day were significant predictors for obesity. Our study showed that the prevalence of obesity in Chinese patients with schizophrenia is higher than that in the general population. Some demographic and clinical variables are risk factors for obesity in schizophrenia. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  15. Variations in genetic assessment and recurrence risks quoted for childhood deafness: a survey of clinical geneticists

    PubMed Central

    Parker, M; Fortnum, H; Young, I; Davis, A

    1999-01-01

    We report here the results of a questionnaire survey of consultant clinical geneticists in the United Kingdom to which we had an 81% response rate. In this questionnaire we asked about: (1) the nature of services currently offered to families with hearing impaired children, (2) what recurrence risks they quoted in isolated non-syndromic cases, and (3) what they might suggest for improving the range of genetic services available at present. We noted great variation both in these services and in the recurrence risks quoted in isolated cases. Based on the results of the questionnaire, we have proposed a protocol for the investigation of permanent childhood hearing impairment, which we believe to be both comprehensive and practical in an outpatient clinic setting. It is only by improving existing clinical and social understanding and knowledge of childhood hearing impairment that it will become possible to use recent molecular advances to develop comprehensive and consistent services for these families.


Keywords: childhood hearing impairment; investigation; genetic; recurrence risks PMID:10051011

  16. CPA Treatment Guidelines for Individuals at Clinical High Risk of Psychosis.

    PubMed

    Addington, Jean; Addington, Donald; Abidi, Sabina; Raedler, Thomas; Remington, Gary

    2017-01-01

    Young people who are at clinical high risk (CHR) of developing psychosis are often help seeking and have significant distress and dysfunction. There are limited guidelines for the assessment and treatment for this population. The aim of this guideline was to develop treatment recommendations for this at-risk group. A systematic search was conducted for published guidelines for CHR. All current guidelines for schizophrenia were reviewed for treatment guidelines on individuals at CHR. The recommendations adopted were primarily drawn from the European Psychiatric Association (EPA) guidance on the early intervention in clinical high-risk states of psychoses and the 2014 National Institute for Health and Care Excellence (NICE) guidelines on the treatment and management of those at CHR for psychosis. After the guideline development process described, 9 recommendations were developed based on the quality of evidence, appropriateness for the Canadian health care system, and clinical expert consensus. Assessment by an expert in the field was the first recommendation. It was recommended that treatment follow a staged approach with psychological treatments being the first-line treatment and pharmacotherapy reserved for adults, those who did not respond to psychological interventions, and those who had more severe symptoms.

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2014-01-01

    To determine risk factors and clinical signs that may differentiate between bacterial, fungal, and acanthamoeba keratitis among patients presenting with presumed infectious keratitis. Hospital-based cross-sectional study. We examined the medical records of 115 patients with laboratory-proven bacterial keratitis, 115 patients with laboratory-proven fungal keratitis, and 115 patients with laboratory-proven acanthamoeba keratitis seen at Aravind Eye Hospital, Madurai, India, from 2006-2011. Risk factors and clinical features of the 3 organisms were compared using multinomial logistic regression. Of 95 patients with bacterial keratitis, 103 patients with fungal keratitis, and 93 patients with acanthamoeba keratitis who had medical records available for review, 287 (99%) did not wear contact lenses. Differentiating features were more common for acanthamoeba keratitis than for bacterial or fungal keratitis. Compared to patients with bacterial or fungal keratitis, patients with acanthamoeba keratitis were more likely to be younger and to have a longer duration of symptoms, and to have a ring infiltrate or disease confined to the epithelium. Risk factors and clinical examination findings can be useful for differentiating acanthamoeba keratitis from bacterial and fungal keratitis. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Effectiveness of physical exercise to reduce cardiovascular risk factors in youths: a randomized clinical trial.

    PubMed

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

    2015-05-01

    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. 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. 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. 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.

  20. Cumulative survival rate and associated risk factors of Implantium implants: A 10-year retrospective clinical study.

    PubMed

    Park, Jin-Hong; Kim, Young-Soo; Ryu, Jae-Jun; Shin, Sang-Wan; Lee, Jeong-Yol

    2017-06-01

    The objective of this study was to determine the cumulative survival rate (CSR) and associated risk factors of Implantium implants by retrospective clinical study. Patients who received Implantium implants (Dentium Co., Seoul, Korea) at Korea University Guro Hospital from 2004 to 2011 were included. The period between the first surgery and the last hospital visit until December 2015 was set as the observation period for this study. Clinical and radiographic data were collected from patient records, including all complications observed during the follow-up period. Kaplan-Meier analysis was performed to examine CSR. Multiple Cox proportional hazard model was employed to assess the associations between potential risk factors and CSR. A total of 370 implants were placed in 121 patients (mean age, 56.1 years; range, 19 to 75 years). Of the 370 implants, 13 failed, including 7 implants that were lost before loading. The 10-year cumulative survival rate of implants was 94.8%. The multiple Cox proportional hazard model revealed that significant risk factor of implant failure were smoking and maxillary implant (P<.05). The 10-year CSR of Implantium implants was 94.8%. Risk factors of implant failure were smoking and maxillary implant.

  1. Prevalence and clinical characteristics of metabolic syndrome for at-risk people in a rural community.

    PubMed

    Oh, Eui Geum; Bang, So Youn; Hyun, Sa Saeng

    2009-02-01

    Substantial socioeconomic and demographic changes have resulted in an increase in the incidence of metabolic syndrome in Korea, especially in aged, postmenopausal women and in rural populations. As rural populations age, metabolic syndrome is expected to be a significant health problem. The purpose of this study was to determine the prevalence and clinical characteristics of metabolic syndrome for an at-risk population in a rural community health-care center. Data were collected from 136 people who were defined as being at risk for metabolic syndrome by being over 40 years of age and being treated for hypertension, diabetes mellitus, dyslipidemia, or central obesity at a rural community health-care center in Korea. Prevalence and clinical characteristics were evaluated by the diagnostic guidelines of National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III) and World Health Organization Asia-Pacific (WHO-AP). The prevalence of metabolic syndrome among this group was 64.7% and 74.3% according to the NCEP-ATP III and WHO-AP criteria, respectively. The prevalence of metabolic syndrome increased with age and was higher in women. Of the five risk factors, fasting blood sugar and central obesity in women were the most prevalent (81.6%), followed by systolic hypertension (80.1%). The prevalence of metabolic syndrome for at-risk people was high in the rural Korean health-care center used in this study. Population-wide management strategies are apparently needed.

  2. Financial and clinical risk in health care reform: a view from below.

    PubMed

    Smith, Pam; Mackintosh, Maureen; Ross, Fiona; Clayton, Julie; Price, Linnie; Christian, Sara; Byng, Richard; Allan, Helen

    2012-04-01

    This paper examines how the interaction between financial and clinical risk at two critical phases of health care reform in England has been experienced by frontline staff caring for vulnerable patients with long term conditions. The paper draws on contracting theory and two interdisciplinary and in-depth qualitative research studies undertaken in 1995 and 2007. Methods common to both studies included documentary analysis and interviews with managers and front line professionals. The 1995 study employed action-based research and included observation of community care; the 2007 study used realistic evaluation and included engagement with service user groups. In both reform processes, financial risk was increasingly devolved to frontline practitioners and smaller organizational units such as GP commissioning groups, with payment by unit of activity, aimed at changing professionals' behaviour. This financing increased perceived clinical risk and fragmented the delivery of health and social care services requiring staff efforts to improve collaboration and integration, and created some perverse incentives and staff demoralisation. Health services reform should only shift financial risk to frontline professionals to the extent that it can be efficiently borne. Where team work is required, contracts should reward collaborative multi-professional activity.

  3. 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

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

    PubMed

    Gomes, Mafalda; Matias, Alexandra; Macedo, Filipe

    2015-12-01

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

  5. Risk factors and clinical profiles in Turkish children with cerebral palsy: analysis of 625 cases.

    PubMed

    Erkin, Gulten; Delialioglu, Sibel Unsal; Ozel, Sumru; Culha, Canan; Sirzai, Hulya

    2008-03-01

    The aim of the study was to investigate risk factors, clinical profiles and gross motor function levels of Turkish children with cerebral palsy (CP). A total of 625 consecutive children with CP, who were rehabilitated in the pediatrics rehabilitation clinic between 2000 and 2004 years, were included. Factors causing CP were investigated by interviewing the families and by scanning medical files. Risk factors were recorded as consanguineous marriage, maternal disorder, preterm birth, birth asphyxia, low birth weight, multiple pregnancy, neonatal convulsion, kernicterus, postnatal central nervous system infection and brain injury. Swedish classification was followed in CP typing. Of 625 children with CP, 370 (59.2%) were males and 255 (40.8%) were females, with ages ranging between 2 and 13 years (the mean age was 5.11+/-2.19 years). It was determined that 47.8% of the cases were spastic diplegic CP, 27.7% were spastic tetraplegic CP, 12.8% spastic hemiplegic CP and 11.7% were other types (ataxic, dyskinetic and mixed CP types). The most frequently encountered risk factors were low birth weight (45.1%), preterm birth (40.5%), birth asphyxia (34.6%) and consanguineous marriage (23.8%). Low birth weight, preterm birth, birth asphyxia and consanguineous marriage were top-ranked risk factors that were determined in Turkish children with CP. Compared with other countries, consanguineous marriage is still an important problem in Turkey.

  6. Predisposing risk factors on susceptibility to exertional heat illness: clinical decision-making considerations.

    PubMed

    Cleary, Michelle

    2007-08-01

    To present strategies for identifying predisposing conditions, susceptibility, and incidence reduction for the most common exertional heat illnesses (EHI): heat cramps, heat exhaustion, and most importantly, heat stroke. A comprehensive literature review of MEDLINE and 1996 to 2006, including all retrospective, controlled studies of EHI risk using the following keywords: exertional heat illness risk, exertional heat stroke risk, and exercise-induced dehydration risk. Search limits included the following: English language, published in the last 10 years, clinical trial, meta-analysis, practice guideline, randomized controlled trial, review, and humans. A manual review was conducted of relevant position statements and book chapters including the reference lists. To evaluate the quality of the empirical studies to be included in this review, each study must have scored at least 17/22 or 77% of items included when reporting a randomized trial using the CONSORT checklist. Many cases of EHI are preventable and can be successfully treated if the ATC identifies individuals at increased relative risk and implement appropriate prevention strategies. The ability to objectively identify individuals at increased relative risk of EHI and to provide appropriate monitoring is critical in EHI prevention and reduction of repeated incidents of EHI. For any heat illness prevention program to be effective, greater attention and continued observation is needed for athletes at high risk for EHI. For many athletic teams or programs, because of the sheer numbers and associated catastrophic injury potential, health care professionals must implement a system by which high-risk individuals are monitored during activity with the highest level of vigilance for prevention of EHI.

  7. Treatment referral for sex offenders based on clinical judgment versus actuarial risk assessment: match and analysis of mismatch.

    PubMed

    Smid, Wineke J; Kamphuis, Jan Henk; Wever, Edwin C; Van Beek, Daan

    2013-07-01

    The Risk Need Responsivity (RNR) principles (Andrews & Bonta, 2010) dictate that higher risk sex offenders should receive more intensive treatment. The present study investigates how clinically based treatment assignment relates to risk level in a sex offender sample from The Netherlands. Correlational analyses served to identify sources of mismatches: that is, variables differing significantly in their relation between treatment selection and risk level. Our study sample consisted of 194 convicted rapists and 214 convicted child molesters. All participants' criminal files were retrospectively coded in terms of the items of the STATIC-99R, PCL: SV, and SVR-20. A low to moderate correlation was observed between clinical treatment selection and actuarial risk levels. A substantial part of the sex offenders, especially child molesters, received overly intensive treatment and another substantial part, especially rapists, received treatment of lesser intensity than indicated by their risk levels. General violent and antisocial risk factors seemed to be underemphasized in the clinical evaluation of sex offenders, especially rapists. A negative attitude toward intervention was negatively associated with clinical treatment selection. It is concluded that clinical treatment selection leads to an insufficient match between risk level and treatment level and systematic use of validated structured risk assessment instruments is necessary to ensure optimal adherence to the risk principle.

  8. Clinical risk factors of prediabetes in Taiwanese women without substance uses (tobacco, alcohol, or areca nut).

    PubMed

    Wu, Wei-Chun; Lin, Pei-Chen; Hung, Chun-Chi; Lin, Hung-Hsun; Cheng, Ching-Mei; Lee, Chung-Yin; Chiu, Kuei-Fen; Lin, Wen-Yi; Huang, Chia-Tsuan; Wu, Ming-Tsang

    2015-12-01

    Individuals with prediabetes (100-125 mg/dL) and diabetes mellitus (DM) increase the risk of all-cause and cardiovascular disease (CVD) mortality. Since personal substance use such as cigarette smoking, alcohol drinking, and areca nut chewing may confound the true effect of clinical biochemistries on the risk of prediabetes, this study aims to examine the relationship between clinical biochemical parameters and the risk of prediabetes among Taiwanese without the habits of consuming tobacco, alcohol drinking, or areca nut. Women aged between 40 years and 64 years who came to one community teaching hospital between January 1, 2001 and December 31, 2008 for general health screening for the first time were studied. The general health screening is provided every 3 years gratis. The package of this health screening includes personal history, physical examination, and biochemical tests in serum and urine. In total, 8580 nonsmoking, nondrinking, and nonareca nut chewing women who did not have a history of DM were eligible for this study. Of these, 1861 (21.7%) out of 8580 women were prediabetic. Compared to women with normal fasting glucose (NFG), we found a dose-response relationship of the risk of prediabetes with age and body mass index (BMI) and total cholesterol, triglyceride, glutamic-pyruvic transaminase (GPT), and uric acid in serum. Women with hypertension or proteinuria (≥30 mg/dL) had also an increased risk to have prediabetes. Besides age, the factors of BMI, hypertension, dyslipidemia, GPT, hyperuricemia, and proteinuria are the main risk factors for prediabetes in Taiwanese women without substance uses. A follow-up study is necessary to clarify the causality of these important biochemical parameters and prediabetes. Copyright © 2014. Published by Elsevier B.V.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  11. Family history of hematologic malignancies and risk of multiple myeloma: differences by race and clinical features.

    PubMed

    VanValkenburg, MaryAnn E; Pruitt, Gwendolyn I; Brill, Ilene K; Costa, Luciano; Ehtsham, Maryam; Justement, Ian T; Innis-Shelton, Racquel D; Salzman, Donna; Reddy, E Shyam P; Godby, Kelly N; Mikhail, Fady M; Carroll, Andrew J; Reddy, Vishnu B; Sanderson, Ralph D; Justement, Louis B; Sanders, Paul W; Brown, Elizabeth E

    2016-01-01

    Multiple myeloma (MM) is the most common hematologic malignancy affecting Blacks in the USA, with standardized incidence rates that are twofold to threefold higher than Whites. The rationale for the disparity is unclear. Using participants enrolled in the Molecular And Genetic Epidemiology study of myeloma (259 MM cases; 461 controls), we examined the risk of MM associated with family history of cancer, differences by race and among cases, defining clinical features. Risk estimates were calculated using odds ratios and corresponding 95% confidence intervals from logistic regression adjusted for confounders. Overall, MM risk in cases with relatives affected with any hematologic malignancy was significantly elevated compared to controls (OR 1.89, 95% CI 1.25-2.86). Myeloma risk associated with a family history of MM was higher than the risk associated with any hematologic malignancy (OR 3.75, 95% CI 1.75-8.05), and the effect was greater for Blacks (OR 20.9, 95% CI 2.59-168) than Whites (OR 2.04, 95% 0.83-5.04), among cases with early onset (≤60 years; OR 4.58, 95% CI 1.21-17.3) and with increasing numbers of affected relatives (p trend = 0.001). Overall, frequencies of end organ damage differed in cases with relatives affected with any hematologic malignancy and significantly more cases exhibited κ light chain restriction (OR 3.23, 95% CI 1.13-9.26). The excess risk of MM observed in Blacks and the variation in clinical features observed in MM patients according to family history of hematologic malignancy may be attributed to a shared germline and environmental susceptibility.

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

    PubMed

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

    2016-03-21

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

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

    PubMed Central

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

    2016-01-01

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

  14. Clinical Risk Factors Associated with Anti-Epileptic Drug Responsiveness in Canine Epilepsy

    PubMed Central

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

    2014-01-01

    The nature and occurrence of remission, and conversely, pharmacoresistance following epilepsy treatment is still not fully understood in human or veterinary medicine. As such, predicting which patients will have good or poor treatment outcomes is imprecise, impeding patient management. In the present study, we use a naturally occurring animal model of pharmacoresistant epilepsy to investigate clinical risk factors associated with treatment outcome. Dogs with idiopathic epilepsy, for which no underlying cause was identified, were treated at a canine epilepsy clinic and monitored following discharge from a small animal referral hospital. Clinical data was gained via standardised owner questionnaires and longitudinal follow up data was gained via telephone interview with the dogs’ owners. At follow up, 14% of treated dogs were in seizure-free remission. Dogs that did not achieve remission were more likely to be male, and to have previously experienced cluster seizures. Seizure frequency or the total number of seizures prior to treatment were not significant predictors of pharmacoresistance, demonstrating that seizure density, that is, the temporal pattern of seizure activity, is a more influential predictor of pharmacoresistance. These results are in line with clinical studies of human epilepsy, and experimental rodent models of epilepsy, that patients experiencing episodes of high seizure density (cluster seizures), not just a high seizure frequency pre-treatment, are at an increased risk of drug-refractoriness. These data provide further evidence that the dog could be a useful naturally occurring epilepsy model in the study of pharmacoresistant epilepsy. PMID:25153799

  15. Fracture Risk Prediction Modeling and Statistics: What Should Clinical Researchers, Journal Reviewers, and Clinicians Know?

    PubMed

    Schousboe, John T; Langsetmo, Lisa; Taylor, Brent C; Ensrud, Kristine E

    Fractures are binary events (they either occur or they do not), and predicting whether fractures may occur involves assigning probabilities of one or more of those events occurring over time to populations and to individuals. Fracture risk prediction has become central to the management of osteoporosis and fracture prevention in clinical practice, and the ultimate clinical usefulness of the prediction tools used to estimate these risks depends, at a minimum, on the validity and accuracy of those tools. In this paper, we will describe how fracture prediction models are developed and validated, and how their performance characteristics are assessed. We will provide a checklist by which clinicians, clinical researchers, and reviewers of journal submissions can judge whether a fracture prediction tool meets basic requirements of good performance. We will further describe how the incremental predictive value of additional diagnostic tools, such as bone mass measurement technologies, is assessed. Copyright © 2017 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2016-10-01

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

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

    PubMed

    Khan, Faizan H; Pandian, Vijayabaskar; Ramraj, Satish Kumar; Aravindan, Sheeja; Natarajan, Mohan; Azadi, Seifollah; Herman, Terence S; Aravindan, Natarajan

    2015-11-03

    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.

  18. Bisphosphonate drug holidays in postmenopausal osteoporosis: effect on clinical fracture risk.

    PubMed

    Mignot, M A; Taisne, N; Legroux, I; Cortet, B; Paccou, J

    2017-09-05

    A cohort of 183 postmenopausal women, who had either discontinued or continued bisphosphonates (BPs) after first-line therapy, was used to investigate the relationships between "drug holiday" and clinical fracture. The risk of new clinical fractures was found to be 40% higher in women who had taken a BP "drug holiday." BPs are the most widely used treatment for postmenopausal osteoporosis. The optimal treatment duration, however, remains unclear. The purpose of this study was to evaluate the fracture risk in postmenopausal women with osteoporosis after discontinuing BP treatment (BP "drug holiday"). A retrospective analysis was performed at Lille University Hospital (LUH) on postmenopausal women with osteoporosis who had taken a "drug holiday" or continued treatment after first-line BP therapy (3 to 5 years). The occurrence of new clinical fractures during follow-up was also explored. Cox proportional hazards models were used to investigate the relationships between BP "drug holiday" and the occurrence of clinical fractures, while controlling for confounding factors. Survival without new clinical fractures was analyzed using Kaplan-Meier curves and log-rank tests. One hundred eighty-three women (mean age: 61.8 years; SD: 8.7) who had previously undergone BP treatment for 3 to 5 years were enrolled in our study. The patients had received alendronate (n = 81), risedronate (n = 73), zoledronic acid (n = 20), and ibandronate (n = 9). In 166 patients ("drug holiday" group: n = 31; continuous-treatment group: n = 135), follow-up ranged from 6 to 36 months (mean duration: 31.8 months; SD: 8.2). The incidences of new clinical fractures during follow-up were 16.1% (5/31) and 11.9% (16/135). After full adjustment, the hazard ratio of new clinical fractures among "drug holiday" patients was 1.40 (95% CI: 1.12-1.60; p = 0.0095). After first-line BP therapy in postmenopausal women with osteoporosis, the risk of new clinical fractures was 40% higher in

  19. 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.

  20. Evaluation of risk factors associated with clinical improvement and survival of horses with equine protozoal myeloencephalitis.

    PubMed

    Saville, W J; Morley, P S; Reed, S M; Granstrom, D E; Kohn, C W; Hinchcliff, K W; Wittum, T E

    2000-10-15

    To investigate risk factors for use in predicting clinical improvement and survival of horses with equine protozoal myeloencephalitis (EPM). Longitudinal epidemiologic study. 251 horses with EPM. Between 1992 and 1995, 251 horses with EPM were admitted to our facility. A diagnosis of EPM was made on the basis of neurologic abnormalities and detection of antibody to Sarcocystis neurona or S neurona DNA in CSF. Data were obtained from hospital records and through telephone follow-up interviews. Factors associated with clinical improvement and survival were analyzed, using multivariable logistic regression. The likelihood of clinical improvement after diagnosis of EPM was lower in horses used for breeding and pleasure activities. Treatment for EPM increased the probability that a horse would have clinical improvement. The likelihood of survival among horses with EPM was lower among horses with more severe clinical signs and higher among horses that improved after EPM was diagnosed. Treatment of horses with EPM is indicated in most situations; however, severity of clinical signs should be taken into consideration when making treatment decisions. Response to treatment is an important indicator of survival.

  1. Generalizing from clinical trial data: A case study. The risk of suicidality among pediatric antidepressant users

    PubMed Central

    Greenhouse, Joel B.; Kaizar, Eloise E.; Kelleher, Kelly; Seltman, Howard; Gardner, William

    2010-01-01

    Summary For the results of randomized controlled clinical trials (RCTs) and related meta-analyses to be useful in practice, they must be relevant to a definable group of patients in a particular clinical setting. To the extent this is so, we say that the trial is generalizable or externally valid. Although concern about the generalizability of the results of RCTs is often discussed, there are few examples of methods for assessing the generalizability of clinical trial data. In this paper, we describe and illustrate an approach for making what we call generalizability judgments and illustrate the approach in the context of a case study of the risk of suicidality among pediatric antidepressant users. PMID:18381709

  2. Modeling tumor control probability for spatially inhomogeneous risk of failure based on clinical outcome data.

    PubMed

    Lühr, Armin; Löck, Steffen; Jakobi, Annika; Stützer, Kristin; Bandurska-Luque, Anna; Vogelius, Ivan Richter; Enghardt, Wolfgang; Baumann, Michael; Krause, Mechthild

    2017-07-01

    Objectives of this work are (1) to derive a general clinically relevant approach to model tumor control probability (TCP) for spatially variable risk of failure and (2) to demonstrate its applicability by estimating TCP for patients planned for photon and proton irradiation. The approach divides the target volume into sub-volumes according to retrospectively observed spatial failure patterns. The product of all sub-volume TCPi values reproduces the observed TCP for the total tumor. The derived formalism provides for each target sub-volume i the tumor control dose (D50,i) and slope (γ50,i) parameters at 50% TCPi. For a simultaneous integrated boost (SIB) prescription for 45 advanced head and neck cancer patients, TCP values for photon and proton irradiation were calculated and compared. The target volume was divided into gross tumor volume (GTV), surrounding clinical target volume (CTV), and elective CTV (CTVE). The risk of a local failure in each of these sub-volumes was taken from the literature. Convenient expressions for D50,i and γ50,i were provided for the Poisson and the logistic model. Comparable TCP estimates were obtained for photon and proton plans of the 45 patients using the sub-volume model, despite notably higher dose levels (on average +4.9%) in the low-risk CTVE for photon irradiation. In contrast, assuming a homogeneous dose response in the entire target volume resulted in TCP estimates contradicting clinical experience (the highest failure rate in the low-risk CTVE) and differing substantially between photon and proton irradiation. The presented method is of practical value for three reasons: It (a) is based on empirical clinical outcome data; (b) can be applied to non-uniform dose prescriptions as well as different tumor entities and dose-response models; and (c) is provided in a convenient compact form. The approach may be utilized to target spatial patterns of local failures observed in patient cohorts by prescribing different doses to

  3. 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

  4. Refitting of the UKPDS 68 risk equations to contemporary routine clinical practice data in the UK.

    PubMed

    McEwan, P; Bennett, H; Ward, T; Bergenheim, K

    2015-02-01

    Economic evaluations of new diabetes therapies rely heavily upon the UK Prospective Diabetes Study (UKPDS) equations for prediction of cardiovascular events; however, concerns persist regarding their relevance to current clinical practice and appropriate use in populations other than newly diagnosed patients. This study refits the UKPDS 68 event equations, using contemporary data describing low- and intermediate-risk patients. Anonymized patient data describing demographics, risk factors and incidence of cardiovascular and microvascular events were extracted from The Health Improvement Network (THIN) database over the 10-year period from 1 January 2000 to 31 December 2009. Following multiple imputation of missing values, accelerated failure-time Weibull regression equations were refitted to produce new coefficients for each risk group. Discriminatory performance was assessed and compared with both UKPDS 68 and UKPDS 82 risk equations, and the implication of coefficient choice within an economic evaluation was assessed using the Cardiff type 2 diabetes model. When applied to patient-level data, the three sets of coefficients (UKPDS, THIN low-risk and intermediate-risk) lead to fairly consistent predictions of the 5-year risk of events. Exceptions include lower predicted rates of myocardial infarction and higher rates of ischaemic heart disease, congestive heart failure and end-stage renal disease with both sets of revised THIN coefficients compared with UKPDS. Over a modelled lifetime, the coefficients derived from the low-risk data predict fewer total cardiovascular events compared with UKPDS, while those from the intermediate-risk data predict a greater number. The areas under the receiver-operating characteristic curves demonstrated a marginal improvement in the discriminatory performance of the refitted equations. The incremental cost-effectiveness ratio associated with dapagliflozin versus sulphonylurea in addition to metformin changed from £7,708 to £7

  5. A clinical model to identify patients with high-risk coronary artery disease.

    PubMed

    Yang, Yelin; Chen, Li; Yam, Yeung; Achenbach, Stephan; Al-Mallah, Mouaz; Berman, Daniel S; Budoff, Matthew J; Cademartiri, Filippo; Callister, Tracy Q; Chang, Hyuk-Jae; Cheng, Victor Y; Chinnaiyan, Kavitha; Cury, Ricardo; Delago, Augustin; Dunning, Allison; Feuchtner, Gudrun; Hadamitzky, Martin; Hausleiter, Jörg; Karlsberg, Ronald P; Kaufmann, Philipp A; Kim, Yong-Jin; Leipsic, Jonathon; LaBounty, Troy; Lin, Fay; Maffei, Erica; Raff, Gilbert L; Shaw, Leslee J; Villines, Todd C; Min, James K; Chow, Benjamin J W

    2015-04-01

    This study sought to develop a clinical model that identifies patients with and without high-risk coronary artery disease (CAD). Although current clinical models help to estimate a patient's pre-test probability of obstructive CAD, they do not accurately identify those patients with and without high-risk coronary anatomy. Retrospective analysis of a prospectively collected multinational coronary computed tomographic angiography (CTA) cohort was conducted. High-risk anatomy was defined as left main diameter stenosis ≥50%, 3-vessel disease with diameter stenosis ≥70%, or 2-vessel disease involving the proximal left anterior descending artery. Using a cohort of 27,125, patients with a history of CAD, cardiac transplantation, and congenital heart disease were excluded. The model was derived from 24,251 consecutive patients in the derivation cohort and an additional 7,333 nonoverlapping patients in the validation cohort. The risk score consisted of 9 variables: age, sex, diabetes, hypertension, current smoking, hyperlipidemia, family history of CAD, history of peripheral vascular disease, and chest pain symptoms. Patients were divided into 3 risk categories: low (≤7 points), intermediate (8 to 17 points) and high (≥18 points). The model was statistically robust with area under the curve of 0.76 (95% confidence interval [CI]: 0.75 to 0.78) in the derivation cohort and 0.71 (95% CI: 0.69 to 0.74) in the validation cohort. Patients who scored ≤7 points had a low negative likelihood ratio (<0.1), whereas patients who scored ≥18 points had a high specificity of 99.3% and a positive likelihood ratio (8.48). In the validation group, the prevalence of high-risk CAD was 1% in patients with ≤7 points and 16.7% in those with ≥18 points. We propose a scoring system, based on clinical variables, that can be used to identify patients at high and low pre-test probability of having high-risk CAD. Identification of these populations may detect those who may benefit

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

    PubMed Central

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

    2016-01-01

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

  7. Environmental and Clinical Risk Factors for Delirium in a Neurosurgical Center: A Prospective Study.

    PubMed

    Matano, Fumihiro; Mizunari, Takayuki; Yamada, Keiko; Kobayashi, Shiro; Murai, Yasuo; Morita, Akio

    2017-07-01

    Few reports of delirium-related risk factors have focused on environmental risk factors and clinical risk factors, such as white matter signal abnormalities on magnetic resonance imaging fluid attenuated inversion recovery images. We prospectively enrolled 253 patients admitted to our neurosurgical center between December 2014 and June 2015 and analyzed 220 patients (100 male patients; mean age, 64.1 years; age range, 17-92 years). An Intensive Care Delirium Screening Checklist score ≥4 points indicated delirium. We evaluated patient factors consisting of baseline characteristics and related factors, such as white matter lesions (WMLs), as well as the surrounding environment. Delirium occurred in 29/220 cases (13.2%). Regarding baseline characteristics, there were significant statistical correlations between delirium and age (P = 0.0187), Hasegawa Dementia Scale-Revised score (P = 0.0022) on admission, and WMLs (P < 0.0001). WMLs were related to age (P < 0.0001) and atherosclerotic disease (P = 0.004). Regarding related factors, there were significant statistical correlations between delirium and stay in a neurosurgical care unit (P = 0.0245). Multivariate logistic regression analyses showed statistically significant correlations of delirium with WMLs (P < 0.0001) and surrounding patients with delirium (P = 0.026). WMLs in patients and the surrounding environment are risk factors for delirium in a neurosurgical center. To prevent delirium, clinicians must recognize risk factors, such as high-grade WMLs, and manage environmental factors. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    PubMed

    Choi, Cheol Ung; Park, Chang Gyu

    2010-09-08

    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. 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. 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). 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.

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

    PubMed Central

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

    2015-01-01

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

  10. Clinical manifestations, treatment outcomes, and risk factors for sternoclavicular septic arthritis.

    PubMed

    Rodchuae, Muchima; Ruangpin, Chonlada; Katchamart, Wanruchada

    2017-02-26

    Septic arthritis of the sternoclavicular joint (SCJ) is an atypical and rarely seen clinical condition. The prognosis for patients with SCJ septic arthritis is often poor. The objective of this study was to compare clinical characteristics between SCJ and non-sternoclavicular joint (NSCJ) septic arthritis and to identify independent risk factors for SCJ septic arthritis. A total of 450 adult patients diagnosed with septic arthritis during the January 2002 to December 2013 study period were included in this retrospective cohort study. Patient characteristics, clinical manifestations, and treatment outcomes were examined. Univariate and multivariate analysis was performed to identify potential risk factors for SCJ septic arthritis. Thirty-three (7.3%) of 450 patients had SCJ septic arthritis and the remaining 417 patients had NSCJ. Oligoarthritis or polyarthritis were seen more often in SCJ patients than in NSCJ patients (55 vs. 19%; p < 0.05). Abscess formation and bacteremia were more commonly found at presentation in the SCJ group than in the NSCJ group (18 vs. 8%; p < 0.05 for abscess formation; and, 53.1 vs. 26.6%; p < 0.05 for bacteremia). In multivariate analysis, extra-articular infection (OR 2.7, 95% CI 1.2-6.4; p = 0.02), cirrhosis (OR 1.9, 95% CI 1.1-3.3; p = 0.02), and malignancy (OR 3, 95% CI 1.1-7.8; p = 0.03) were independent risk factors for SCJ septic arthritis. SCJ septic arthritis is an uncommon septic arthritis that frequently presents with local and systemic complications. Factors found to be significantly associated with SCJ septic arthritis were extra-articular infection and immunocompromised host. A high index of suspicion in high-risk patients is the key to achieving improved outcomes.

  11. 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.

  12. [Environmental factors, clinical signs, therapy and zoonotic risk of rabbits with dermatophytosis].

    PubMed

    Krämer, A; Müller, R S; Hein, J

    2012-01-01

    The aim of this study was to evaluate the environmental factors, clinical signs, therapy and zoonotic risk of pet rabbits with dermatophytosis. In the present study, questionnaires with separate questions for the veterinarian and the owners were sent to veterinarians who treated rabbits with positive fungal cultures. Eleven of the questionnaires were completed by veterinarians and owners, while eight questionnaires were exclusively answered by the veterinarians. The questionnaires included questions on the environment of the animals (origin, maintenance, feeding, group size, new arrivals, changes), clinical signs, diagnosis, therapy and zoonosis. Trichophyton (T.) mentagrophytes (m.) was the most frequently isolated dermatophyte species (15/19). Half of the animals were younger than five months and female rabbits were affected twice as frequently. In four of 11 cases new rabbits arrived in the household in the weeks prior to the onset of the dermatophytosis and in seven cases the affected animals lived in the household for less than three months. The typical group size was two animals and in half of the cases the companion rabbit was also affected. The rabbits most often showed alopecia with scaling and/or crusts, especially on the head, the ears being affected in half these animals. In three of 11 cases (27.3%) children in the family showed clinical signs of dermatophytosis, with lesions located on the hands, face and shoulder. Pet rabbits with dermatophytosis must be considered a serious zoonotic risk for their owners, especially children. In this study, risk factors for dermatophytosis appear to be the recent acquisition of a new rabbit and the age of the animals. In rabbits with alopecia with scaling and/or crusts on the head, a dermatophyte infection should be ruled out. The owner should be adequately informed about the zoonotic risk of dermatophytosis, especially if children live in the household.

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

    PubMed

    Bartz, Hans-Jürgen

    2015-01-01

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

  14. Theory of Mind in Patients at Clinical High Risk for Psychosis

    PubMed Central

    Stanford, Arielle D.; Messinger, Julie; Malaspina, Dolores; Corcoran, Cheryl M.

    2011-01-01

    Background Patients with schizophrenia have a decreased ability to interpret the intentions of other individuals, called Theory of Mind (ToM). As capacity for ToM normally advances with brain maturation, research on ToM in individuals at heightened clinical risk for psychosis may reveal developmental differences independent of disease based differences. Methods We examined ToM in at clinical high risk and schizophrenia patients as well as healthy controls: 1) 63 clinical high risk (CHR) patients and 24 normal youths ascertained by a CHR program; and 2) in 13 schizophrenia cases and 14 normal adults recruited through a schizophrenia program. ToM measures included first- and second-order false belief cartoon tasks (FBT) and two “higher order” tasks (“Strange Stories Task” (SST) and the “Reading the Mind in the Eyes” task). In the first study, CHR patients and normal youths were also assessed for cognition, “prodromal” symptoms and social function. Results Errors on first- and second-order false belief tasks were made primarily by patients. CHR patients and their young comparison group had equivalent performance on higher order ToM, which was not significantly different from the worse ToM performance of schizophrenia patients and the higher performance of normal adult controls. In the combined dataset from both studies, all levels of ToM were associated with IQ, controlling for age and sex. ToM bore no relation to explicit memory, prodromal symptoms, social function, or later transition to psychosis. Conclusions Higher order ToM capacity was equally undeveloped in high risk cases and younger controls, suggesting performance on these tasks is not fully achieved until adulthood. This study also replicates the association of IQ with ToM performance described in previous studies of schizophrenia. PMID:21757324

  15. Risk assessment of deep-vein thrombosis after acute stroke: a prospective study using clinical factors.

    PubMed

    Liu, Li-Ping; Zheng, Hua-Guang; Wang, David Z; Wang, Yi-Long; Hussain, Mohammed; Sun, Hai-Xin; Wang, An-Xin; Zhao, Xing-Quan; Dong, Ke-Hui; Wang, Chun-Xue; He, Wen; Ning, Bin; Wang, Yong-Jun

    2014-05-01

    Deep-vein thrombosis (DVT) represents a serious complication in acute stroke patients with pulmonary embolus (PE) as a potential outcome. Prediction of DVT may help with formulating a proper prevention strategy. To assess of the risk of deep venous thrombosis (DVT) in acute stroke patients, we developed and validated a clinical score in a cohort study. Incidence of Deep Venous Thrombosis after Acute Stroke in China (INVENT-China) is a multicenter prospective cohort study. The potential predictive variables for DVT at baseline were collected, and the presence of DVT was evaluated using ultrasonography on the 14 ± 3 days. Data were randomly assigned to either a training data set or a test data set. Multivariate logistic regression analysis was used to develop risk scores to predict DVT in the training data set and the area under the receiver operating characteristic curve to validate the score in the test data set. From 2006-2007, 862 hospital-based acute stroke patients were enrolled in China. The overall incidence of DVT after acute stroke within two weeks was 12.4% (95%CI 10.3-14.7%). A seven-point score derived in the training data set (age [≥65 years = 1], sex [female gender = 1]), obesity [BMI ≥ 25 kg/m(2) = 1], active cancer [yes = 2], stroke subtype [cerebral hemorraghe = 1], muscle weakness [≥2 on Lower limb NIHSS score = 1] was highly predictive of 14-day risk of DVT(c statistic = 0.70, 95% CI, 0.64-0.76, P < 0.001), in the overall study population(c statistic = 0.65, 95% CI 0.59-0.70, P < 0.001). This clinical score may help identify acute stroke patients with high risk of DVT. In addition, it also serves as a platform to develop further models of DVT prediction in stroke patients based on clinical factors. © 2014 John Wiley & Sons Ltd.

  16. 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

  17. Can unstructured clinical risk judgment have incremental validity in the prediction of recidivism in a non-Western juvenile context?

    PubMed

    Mori, Takemi; Takahashi, Masaru; Kroner, Daryl G

    2017-02-01

    Research has consistently shown that actuarial measures are superior to unstructured clinical judgments in predicting recidivism of offenders. However, in a non-Western context, clinical judgment may capture contextually relevant risk-related factors. The purpose of the current research is to investigate the incremental value of clinical risk judgment in a sample of Japanese youths. With a sample of 299 released youths, the relative accuracy of the actuarial predictor (Youth Level of Service/Case Management Inventory [YLS/CMI]) and unstructured clinical judgment (recommendation of placement by psychologists) was examined. Results show that an unstructured clinical judgment failed to add incremental variance to the actuarial measure in the prediction of future offenses. The current study results are similar to other studies from North America. Possible reasons why unstructured risk judgment did not add incrementally to the actuarial assessment of risk are discussed. (PsycINFO Database Record

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

    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

    2016-01-01

    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

  20. Clinical analysis and risk stratification of ventricular septal rupture following acute myocardial infarction.

    PubMed

    Hu, Xiao-Ying; Qiu, Hong; Qiao, Shu-Bin; Kang, Lian-Ming; Song, Lei; Zhang, Jun; Tan, Xiao-Yan; Wu, Yuan; Yang, Yue-Jin; Gao, Run-Lin; Chen, Zai-Jia

    2013-11-01

    Ventricular septal rupture (VSR) remains an infrequent but devastating complication of acute myocardial infarction (AMI). The best time to undergo surgical repair is controversial and there is currently no risk stratification for patients with VSR to guide treatment. The purpose of this study was to review the clinical outcomes of 70 patients with VSR, to analyze the short-term prognosis factors of VSR following AMI, and to make a risk stratification for patients with VSR. A total of 70 consecutive VSR patients following AMI treated in our hospital from January 2002 to October 2010 were enrolled in this study retrospectively. The difference of clinical characteristics were observed between patients with VSR who survived ≤30 days and survived >30 days. We analyzed the short-term prognosis factors of VSR and established the short-term prognosis index of VSR (SPIV) based on the Logistic regression analysis to stratify patients with VSR. Among 12 354 patients with acute ST-segment elevation myocardial infarction, 70 (0.57%) patients (33 males and 37 females) were found to have VSR. The average age was (68.1±8.5) years. Fifty-four (77.1%) patients were diagnosed with an acute anterior infarction. Patients with VSR selected for surgical repair had better outcomes than patients treated conservatively; 1-year mortality 9.5% versus 87.8%, P < 0.005. Logistic regression analysis revealed that female (P = 0.013), anterior AMI (P = 0.023), non-ventricular aneurysm (P = 0.023), non-diabetes (P = 0.009), Killip class 3 or 4 (P = 0.022) and time from AMI to VSR less than 4 days (P = 0.027) were independent risk determinants for shortterm mortality. SPIV ≥9 indicates a high risk as the 30-day mortality is 77.4%; SPIV <8 indicates a low risk as the 30-day mortality is 28.6%; SPIV between 8 and 9 indicates a moderate risk. VSR remains a rare but devastating complication of AMI. The independent risk determinants for short-term mortality of VSR were female gender, anterior AMI

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  3. Calcium intake and risk of cardiovascular disease: a review of prospective studies and randomized clinical trials.

    PubMed

    Wang, Lu; Manson, JoAnn E; Sesso, Howard D

    2012-04-01

    The potential effects of inadequate or excessive calcium supply on cardiovascular disease (CVD) are receiving growing attention. We review experimental, epidemiologic, and clinical evidence regarding the role of calcium intake in the development of CVD in adults. In vitro and in vivo laboratory studies have shown that calcium may affect the risk of developing CVD through multiple mechanisms including blood cholesterol, insulin secretion and sensitivity, vasodilation, inflammatory profile, thrombosis, obesity, and vascular calcification. A number of prospective epidemiologic studies have examined the relationship between dietary calcium intake and CVD incidence or mortality in middle-aged and older adults. The results were inconsistent, and the pooled data do not strongly support a significant effect of greater dietary calcium intake on the risk of coronary artery disease (CAD) or stroke. Only a few prospective studies have examined calcium supplement use in association with risk of CVD. The pooled data show no significant benefits of calcium supplement use in reducing the risk of CAD or stroke. No randomized clinical trial has specifically tested the effect of calcium supplementation on CVD as its primary endpoint. Secondary analyses in existing trials to date suggest a neutral effect of calcium (with or without vitamin D) supplements on CVD events, but do not allow for a definitive conclusion. A large percentage of Americans, particularly older adults, fail to meet the US recommendations for optimal calcium intake and are encouraged to increase daily calcium consumption. More prospective cohort studies and large-scale randomized trials are needed to further evaluate the risks or benefits of calcium supplementation on CVD endpoints as the primary pre-specified outcome.

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

    PubMed Central

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

    2009-01-01

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

  5. [Zoledronic acid reduces risk of any new clinical fracture and risk of death after surgical repair of a low-trauma hip fracture].

    PubMed

    Leszczyński, Piotr

    2010-01-01

    The most common treatment option for postmenopausal osteoporosis are the bisphosphonates which inhibit osteoclast function. Bisphosphonates interfere with cellular metabolism and in large clinical trials reduce risk of vertebral and non-vertebral fractures. Zoledronic acid is a potent bisphosphonate also approved for the treatment of postmenopausal osteoporosis. In addition zoledronic acid reduce relative risk of any new clinical fracture after surgical repair of low-trauma hip fracture. Also the reduction in the relative risk of death was observed after repeated once-yearly intravenous infusion. In conclusion, this is another interesting option for the treatment of the patients affected with osteoporosis and previous hip fractures.

  6. Clinically relevant quality measures for risk factor control in primary care: a retrospective cohort study.

    PubMed

    Weiler, Stefan; Gemperli, Armin; Collet, Tinh-Hai; Bauer, Douglas C; Zimmerli, Lukas; Cornuz, Jacques; Battegay, Edouard; Gaspoz, Jean-Michel; Kerr, Eve A; Aujesky, Drahomir; Rodondi, Nicolas

    2014-07-15

    Assessment of the proportion of patients with well controlled cardiovascular risk factors underestimates the proportion of patients receiving high quality of care. Evaluating whether physicians respond appropriately to poor risk factor control gives a different picture of quality of care. We assessed physician response to control cardiovascular risk factors, as well as markers of potential overtreatment in Switzerland, a country with universal healthcare coverage but without systematic quality monitoring, annual report cards on quality of care or financial incentives to improve quality. We performed a retrospective cohort study of 1002 randomly selected patients aged 50-80 years from four university primary care settings in Switzerland. For hypertension, dyslipidemia and diabetes mellitus, we first measured proportions in control, then assessed therapy modifications among those in poor control. "Appropriate clinical action" was defined as a therapy modification or return to control without therapy modification within 12 months among patients with baseline poor control. Potential overtreatment of these conditions was defined as intensive treatment among low-risk patients with optimal target values. 20% of patients with hypertension, 41% with dyslipidemia and 36% with diabetes mellitus were in control at baseline. When appropriate clinical action in response to poor control was integrated into measuring quality of care, 52 to 55% had appropriate quality of care. Over 12 months, therapy of 61% of patients with baseline poor control was modified for hypertension, 33% for dyslipidemia, and 85% for diabetes mellitus. Increases in number of drug classes (28-51%) and in drug doses (10-61%) were the most common therapy modifications. Patients with target organ damage and higher baseline values were more likely to have appropriate clinical action. We found low rates of potential overtreatment with 2% for hypertension, 3% for diabetes mellitus and 3-6% for dyslipidemia. In

  7. A clinical decision rule to identify children at low risk for appendicitis.

    PubMed

    Kharbanda, Anupam B; Taylor, George A; Fishman, Steven J; Bachur, Richard G

    2005-09-01

    Computed tomography (CT) has gained widespread acceptance in the evaluation of children with suspected appendicitis. Concern has been raised regarding the long-term effects of ionizing radiation. Other means of diagnosing appendicitis, such as clinical scores, are lacking in children. We sought to develop a clinical decision rule to predict which children with acute abdominal pain do not have appendicitis. Prospective cohort study was conducted of children and adolescents who aged 3 to 18 years, had signs and symptoms suspicious for appendicitis, and presented to the emergency department between April 2003 and July 2004. Standardized data-collection forms were completed on eligible patients. Two low-risk clinical decision rules were created and validated using logistic regression and recursive partitioning. The sensitivity, negative predictive value (NPV), and negative likelihood ratio of each clinical rule were compared. A total of 601 patients were enrolled. Using logistic regression, we created a 6-part score that consisted of nausea (2 points), history of focal right lower quadrant pain (2 points), migration of pain (1 point), difficulty walking (1 point), rebound tenderness/pain with percussion (2 points), and absolute neutrophil count of >6.75 x 10(3)/microL (6 points). A score < or =5 had a sensitivity of 96.3% (95% confidence interval [CI]: 87.5-99.0), NPV of 95.6% (95% CI: 90.8-99.0), and negative likelihood ratio of .102 (95% CI: 0.026-0.405) in the validation set. Using recursive partitioning, a second low-risk decision rule was developed consisting of absolute neutrophil count of <6.75 x 10(3)/microL, absence of nausea, and absence of maximal tenderness in the right lower quadrant. This rule had a sensitivity of 98.1% (95% CI: 90.1-99.9), NPV of 97.5% (95% CI: 86.8-99.9), and negative likelihood ratio of 0.058 (95% CI: 0.008-0.411) in the validation set. Theoretical application of the low-risk rules would have resulted in a 20% reduction in CT. Our low-risk

  8. 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

  9. Clinical utility of genetic signatures in selecting adjuvant treatment: