Multiple primary malignant neoplasms in patients treated with definitive chemoradiotherapy for esophageal cancer

International Nuclear Information System (INIS)

Yamashita, Keishi; Muto, Manabu; Ohtsu, Atsushi; Mera, Kiyomi; Doi, Toshihiko; Sano, Yasushi; Yoshida, Shigeaki

2003-01-01

We reviewed our clinical experiences of chemoradiotherapy (CRT) for esophageal cancer (EC) in 44 patients with multiple primary malignant neoplasms. Among them, 34 were accompanied with synchronous tumors, 8 were accompanied with antecedent tumors and 8 with subsequent tumors. The sites of primary malignant neoplasms were as follows; stomach 24 (43.6%), head and neck 17 (30.9%), colon and rectum 4 (7.3%). Among the 19 patients with synchronous cancer in the stomach, 6 patients underwent gastrectomy or endoscopic mucosal resection before CRT, and the others received definitive CRT as initial treatment. While 5 patients were alive without recurrence of EC and gastric cancer, more than half of the patients died of EC. Among 11 patients with head and neck cancer (HNC), 9 patients underwent surgery for HNC before CRT, because the clinical stages of the HNC was more progressive than that of EC. Only 3 patients achieved complete cure of both EC and HNC. The number of patients who developed subsequent tumors after CRT for EC was too small for us to draw definitive conclusions from our discussion, so further long-term follow-up and analysis based on large-scale surveys are required. Although CRT has become one of the standard treatments for EC, there is no treatment strategy for patients with both EC and other malignant primary neoplasms. Our results suggest that we should consider the curability of EC by CRT when we treat such patients. (author)

Acute Kidney Injury: Definition, Pathophysiology and Clinical Phenotypes.

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Makris, Konstantinos; Spanou, Loukia

2016-05-01

Acute kidney injury (AKI) is a clinical syndrome that complicates the course and worsens the outcome in a significant number of hospitalised patients. Recent advances in clinical and basic research will help with a more accurate definition of this syndrome and in the elucidation of its pathogenesis. With this knowledge we will be able to conduct more accurate epidemiologic studies in an effort to gain a better understanding of the impact of this syndrome. AKI is a syndrome that rarely has a sole and distinct pathophysiology. Recent evidence, in both basic science and clinical research, is beginning to change our view for AKI from a single organ failure syndrome to a syndrome where the kidney plays an active role in the progress of multi-organ dysfunction. Accurate and prompt recognition of AKI and better understanding of the pathophysiologic mechanisms underlying the various clinical phenotypes are of great importance to research for effective therapeutic interventions. In this review we provide the most recent updates in the definition, epidemiology and pathophysiology of AKI.

Putting the puzzle together: the role of 'problem definition' in complex clinical judgement.

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Cristancho, Sayra; Lingard, Lorelei; Forbes, Thomas; Ott, Michael; Novick, Richard

2017-02-01

We teach judgement in pieces; that is, we talk about each aspect separately (patient, plan, resources, technique, etc.). We also let trainees figure out how to put the pieces together. In complex situations, this might be problematic. Using data from a drawing-based study on surgeons' experiences with complex situations, we explore the notion of 'problem definition' in real-world clinical judgement using the theoretical lens of systems engineering. 'Emergence', the sensitising concept for analysis, is rooted in two key systems premises: that person and context are inseparable and that what emerges is an act of choice. Via a 'gallery walk' we used these premises to perform analysis on individual drawings as well as cross-comparisons of multiple drawings. Our focus was to understand similarities and differences among the vantage points used by multiple surgeons. In this paper we challenge two assumptions from current models of clinical judgement: that experts hold a fixed and static definition of the problem and that consequently the focus of the expert's work is on solving the problem. Each situation described by our participants revealed different but complementary perspectives of what a surgical problem might come to be: from concerns about ensuring standard of care, to balancing personal emotions versus care choices, to coordinating resources, and to maintaining control while in the midst of personality clashes. We suggest that it is only at the situation and system level, not at the individual level, that we are able to appreciate the nuances of defining the problem when experts make judgements during real-world complex situations. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Empirical Derivation and Validation of a Clinical Case Definition for Neuropsychological Impairment in Children and Adolescents.

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Beauchamp, Miriam H; Brooks, Brian L; Barrowman, Nick; Aglipay, Mary; Keightley, Michelle; Anderson, Peter; Yeates, Keith O; Osmond, Martin H; Zemek, Roger

2015-09-01

Neuropsychological assessment aims to identify individual performance profiles in multiple domains of cognitive functioning; however, substantial variation exists in how deficits are defined and what cutoffs are used, and there is no universally accepted definition of neuropsychological impairment. The aim of this study was to derive and validate a clinical case definition rule to identify neuropsychological impairment in children and adolescents. An existing normative pediatric sample was used to calculate base rates of abnormal functioning on eight measures covering six domains of neuropsychological functioning. The dataset was analyzed by varying the range of cutoff levels [1, 1.5, and 2 standard deviations (SDs) below the mean] and number of indicators of impairment. The derived rule was evaluated by bootstrap, internal and external clinical validation (orthopedic and traumatic brain injury). Our neuropsychological impairment (NPI) rule was defined as "two or more test scores that fall 1.5 SDs below the mean." The rule identifies 5.1% of the total sample as impaired in the assessment battery and consistently targets between 3 and 7% of the population as impaired even when age, domains, and number of tests are varied. The NPI rate increases in groups known to exhibit cognitive deficits. The NPI rule provides a psychometrically derived method for interpreting performance across multiple tests and may be used in children 6-18 years. The rule may be useful to clinicians and scientists who wish to establish whether specific individuals or clinical populations present within expected norms versus impaired function across a battery of neuropsychological tests.

Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials.

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Bellera, Carine A; Pulido, Marina; Gourgou, Sophie; Collette, Laurence; Doussau, Adélaïde; Kramar, Andrew; Dabakuyo, Tienhan Sandrine; Ouali, Monia; Auperin, Anne; Filleron, Thomas; Fortpied, Catherine; Le Tourneau, Christophe; Paoletti, Xavier; Mauer, Murielle; Mathoulin-Pélissier, Simone; Bonnetain, Franck

2013-03-01

In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial's results by affecting estimation of treatments' effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials. We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner. Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs). The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials' results. Copyright © 2012 Elsevier Ltd. All rights reserved.

Usefulness of two clinical chorioamnionitis definitions in predicting neonatal infectious outcomes: a systematic review.

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Avila, Cecilia; Willins, Jennifer L; Jackson, Matthew; Mathai, Jacob; Jabsky, Marina; Kong, Alex; Callaghan, Fiona; Ishkin, Selda; Shroyer, A Laurie W

2015-09-01

To assess the usefulness of two definitions of acute clinical chorioamnionitis (ACCA) in predicting risk of neonatal infectious outcomes (NIO) and mortality, the first definition requiring maternal fever alone (Fever), and the second requiring ≥ 1 Gibbs criterion besides fever (Fever + 1). PubMed, Web of Science, and the Cochrane Database of Systematic Reviews were searched from January 1, 1979 to April 9, 2013. Twelve studies were reviewed (of 316 articles identified): three studies with term patients, four with preterm premature rupture of membranes (PPROM) patients, and five mixed studies with mixed gestational ages and/or membrane status (intact and/or ruptured). Both definitions demonstrated an increased NIO risk for ACCA versus non-ACCA patients, with an odds ratio increase for the Fever + 1 definition that was about twofold larger than the Fever definition. As the Fever definition demonstrated increased NIO risk for ACCA versus non-ACCA patients, the Fever alone ACCA definition should be used to trigger future clinical treatment in many clinical situations. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

How Important are the Laws of Definite and Multiple Proportions in Chemistry and Teaching Chemistry? A History and Philosophy of Science Perspective

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Niaz, Mansoor

The main objectives of this study are:(1) to elaborate a framework based on a rational reconstruction of developments that led to the formulation of the laws of definite and multiple proportions; (2) to ascertain students' views of the two laws; (3) to formulate criteria based on the framework for evaluating chemistry textbooks' treatment of the two laws; and (4) to provide a rationale for chemistry teachers to respond to the question: Can we teach chemistry without the laws of definite and multiple proportions? Results obtained show that most of the textbooks present the laws of definite and multiple proportions within an inductivist perspective, characterized by the following sequence: experimental findings showed that chemical elements combined in fixed/multiple proportions, followed by the formulation of the laws of definite and multiple proportions, and finally Dalton's atomic theory was postulated to explain the laws. Students were found to be reluctant to question the laws that they learnt as the building blocks of chemistry. It is concluded that by emphasizing the laws of definite and multiple proportions, textbooks inevitably endorse the dichotomy between theories and laws, which is questioned by philosophers of science (Lakatos 1970; Giere 1995a, b). An alternative approach is presented which shows that we can teach chemistry without the laws of definite and multiple proportions.

Pain clinic definitions in the medical literature and U.S. state laws: an integrative systematic review and comparison.

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Andraka-Christou, Barbara; Rager, Joshua B; Brown-Podgorski, Brittany; Silverman, Ross D; Watson, Dennis P

2018-05-22

In response to widespread opioid misuse, ten U.S. states have implemented regulations for facilities that primarily manage and treat chronic pain, called "pain clinics." Whether a clinic falls into a state's pain clinic definition determines the extent to which it is subject to oversight. It is unclear whether state pain clinic definitions model those found in the medical literature, and potential differences lead to discrepancies between scientific and professionally guided advice found in the medical literature and actual pain clinic practice. Identifying discrepancies could assist states to design laws that are more compatible with best practices suggested in the medical literature. We conducted an integrative systematic review to create a taxonomy of pain clinic definitions using academic medical literature. We then identified existing U.S. state pain clinic statutes and regulations and compared the developed taxonomy using a content analysis approach to understand the extent to which medical literature definitions are reflected in state policy. In the medical literature, we identified eight categories of pain clinic definitions: 1) patient case mix; 2) single-modality treatment; 3) multidisciplinary treatment; 4) interdisciplinary treatment; 5) provider supervision; 6) provider composition; 7) marketing; and 8) outcome. We identified ten states with pain clinic laws. State laws primarily include the following definitional categories: patient case mix; single-modality treatment, and marketing. Some definitional categories commonly found in the medical literature, such as multidisciplinary treatment and interdisciplinary treatment, rarely appear in state law definitions. This is the first study to our knowledge to develop a taxonomy of pain clinic definitions and to identify differences between pain clinic definitions in U.S. state law and medical literature. Future work should explore the impact of different legal pain clinic definitions on provider decision

Intestinal Failure: New Definition and Clinical Implications.

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Kappus, Matthew; Diamond, Sarah; Hurt, Ryan T; Martindale, Robert

2016-09-01

Intestinal failure (IF) is a state in which the nutritional demands of the body are not met by the gastrointestinal absorptive surface. It is a long-recognized complication associated with short bowel syndrome, which results in malabsorption after significant resection of the intestine for many reasons or functional dysmotility. Etiologies have included Crohn's disease, vascular complications, and the effects of radiation enteritis, as well as the effects of intestinal obstruction, dysmotility, or congenital defects. While IF has been long-recognized, it has historically not been uniformly defined, which has made both recognition and management challenging. This review examines the previous definitions of IF as well as the newer definition and classification of IF and how it is essential to IF clinical guidelines.

Tuberculous meningitis: a uniform case definition for use in clinical research.

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Marais, Suzaan; Thwaites, Guy; Schoeman, Johan F; Török, M Estée; Misra, Usha K; Prasad, Kameshwar; Donald, Peter R; Wilkinson, Robert J; Marais, Ben J

2010-11-01

Tuberculous meningitis causes substantial mortality and morbidity in children and adults. More research is urgently needed to better understand the pathogenesis of disease and to improve its clinical management and outcome. A major stumbling block is the absence of standardised diagnostic criteria. The different case definitions used in various studies makes comparison of research findings difficult, prevents the best use of existing data, and limits the management of disease. To address this problem, a 3-day tuberculous meningitis workshop took place in Cape Town, South Africa, and was attended by 41 international participants experienced in the research or management of tuberculous meningitis. During the meeting, diagnostic criteria were assessed and discussed, after which a writing committee was appointed to finalise a consensus case definition for tuberculous meningitis for use in future clinical research. We present the consensus case definition together with the rationale behind the recommendations. This case definition is applicable irrespective of the patient's age, HIV infection status, or the resources available in the research setting. Consistent use of the proposed case definition will aid comparison of studies, improve scientific communication, and ultimately improve care. Copyright © 2010 Elsevier Ltd. All rights reserved.

The metabolic syndrome: validity and utility of clinical definitions for cardiovascular disease and diabetes risk prediction.

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Cameron, Adrian

2010-02-01

The purpose of clinical definitions of the metabolic syndrome is frequently misunderstood. While the metabolic syndrome as a physiological process describes a clustering of numerous age-related metabolic abnormalities that together increase the risk for cardiovascular disease and type 2 diabetes, clinical definitions include obesity which is thought to be a cause rather than a consequence of metabolic disturbance, and several elements that are routinely measured in clinical practice, including high blood pressure, high blood glucose and dyslipidaemia. Obesity is frequently a central player in the development of the metabolic syndrome and should be considered a key component of clinical definitions. Previous clinical definitions have differed in the priority given to obesity. Perhaps more importantly than its role in a clinical definition, however, is obesity in isolation before the hallmarks of metabolic dysfunction that typify the syndrome have developed. This should be treated seriously as an opportunity to prevent the consequences of the global diabetes epidemic now apparent. Clinical definitions were designed to identify a population at high lifetime CVD and type 2 diabetes risk, but in the absence of several major risk factors for each condition, are not optimal risk prediction devices for either. Despite this, the metabolic syndrome has several properties that make it a useful construct, in conjunction with short-term risk prediction algorithms and sound clinical judgement, for the identification of those at high lifetime risk of CVD and diabetes. A recently published consensus definition provides some much needed clarity about what a clinical definition entails. Even this, however, remains a work in progress until more evidence becomes available, particularly in the area of ethnicity-specific waist cut-points. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Enhancing clinical decision making: development of a contiguous definition and conceptual framework.

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Tiffen, Jennifer; Corbridge, Susan J; Slimmer, Lynda

2014-01-01

Clinical decision making is a term frequently used to describe the fundamental role of the nurse practitioner; however, other terms have been used interchangeably. The purpose of this article is to begin the process of developing a definition and framework of clinical decision making. The developed definition was "Clinical decision making is a contextual, continuous, and evolving process, where data are gathered, interpreted, and evaluated in order to select an evidence-based choice of action." A contiguous framework for clinical decision making specific for nurse practitioners is also proposed. Having a clear and unique understanding of clinical decision making will allow for consistent use of the term, which is relevant given the changing educational requirements for nurse practitioners and broadening scope of practice. Copyright © 2014 Elsevier Inc. All rights reserved.

What is "grazing"? Reviewing its definition, frequency, clinical characteristics, and impact on bariatric surgery outcomes, and proposing a standardized definition.

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Conceição, Eva M; Mitchell, James E; Engel, Scott G; Machado, Paulo P P; Lancaster, Kathryn; Wonderlich, Stephen A

2014-01-01

Grazing, characterized by a repetitive eating pattern, has received increased attention among bariatric surgery patients. However, different definitions and terminology have been used, preventing the accurate measurement of this phenomenon and comparison of data across studies. To review existing definitions and associated clinical features of grazing among different samples and to propose a standardized definition that will allow for consistency in future work. University and Clinical Research Institute. Of the 39 studies found, 9 provided an original definition and 12 provided data of its association with weight outcomes. Six were studies of nonbariatric surgery populations. Based on this literature review, the most common criteria used in previous studies to define grazing were included in a survey that was sent to 24 individuals who have published work in the field. These experts were asked to provide their opinion on what should constitute grazing. Grazing is a frequent behavior in the bariatric surgery population as well as in eating disordered and community samples. Its association with psychopathology is not clear, but its negative impact on weight outcomes after bariatric surgery generally has been supported. Survey data provided a consensus regarding the definition of grazing as an eating behavior characterized by the repetitive eating (more than twice) of small/modest amounts of food in an unplanned manner, with what we characterize as compulsive and noncompulsive subtypes. Given the clinical relevance of grazing among bariatric surgery patients, a unique definition is crucial to better study its associated features and impact on different populations. Copyright © 2014 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Evaluation of the WHO clinical case definition for pediatric HIV infection in Bloemfontein, South Africa.

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van Gend, Christine L; Haadsma, Maaike L; Sauer, Pieter J J; Schoeman, Cornelius J

2003-06-01

The WHO clinical case definition for pediatric HIV infection has been designed to be used in countries where diagnostic laboratory resources are limited. We evaluated the WHO case definition to determine whether it is a useful instrument to discriminate between HIV-positive and HIV-negative children. In addition, clinical features not included in this case definition were recorded. We recorded clinical data from 300 consecutively admitted children in a state hospital in Bloemfontein, South Africa, and tested these children for HIV infection. A total of 222 children were included in the study; 69 children (31.1 per cent) were HIV positive. The sensitivity of the WHO case definition in this study was 14.5 per cent, the specificity was 98.6 per cent. Apart from weight loss and generalized dermatitis, the signs of the WHO case definition were significantly more often seen in HIV-positive than in HIV-negative children. Of the clinical signs not included in the WHO case definition, marasmus and hepatosplenomegaly especially occurred more frequently in HIV-positive children. Based on these findings we composed a new case definition consisting of four signs: marasmus, hepatosplenomegaly, oropharyngeal candidiasis, and generalized lymphadenopathy. HIV infection is suspected in a child presenting with at least two of these four signs. The sensitivity of this case definition was 63.2 per cent, the specificity was 96.0 per cent. We conclude that in this study the WHO case definition was not a useful instrument to discriminate between HIV-positive and HIV-negative children, mainly because its sensitivity was strikingly low. The simplified case definition we propose, proved to be more sensitive than the WHO case definition (63.2 vs. 14.5 per cent), whilst its specificity remained high.

Temporomandibular joint disorder in a patient with multiple sclerosis--review of literature with a clinical report.

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Badel, Tomislav; Carek, Andreja; Podoreski, Dijana; Pavicin, Ivana Savić; Lovko, Sandra Kocijan

2010-09-01

Temporomandibular disorders are a form of musculoskeletal disorders, which reduce the function of stomatognathic system and they are related to some other diseases causing painful conditions and disorders of oral function. The aim of this paper is to describe a one year follow up clinical case of a female patient with comorbid multiple sclerosis and a relatively rare form of articular disc disorder. Primary clinical diagnostics encompassed manual methods of TMJ examination. Definite diagnosis included radiologic examination. Clinical hyperextensive condyle position was palpated bilaterally and subsequently confirmed by a functional panoramic radiograph of TMJ. The anterior displacement of disc with reduction was diagnosed by magnetic resonance and in the right joint there was a disc displacement upon excursive movement. From relevant literature, the relationship of a number of diseases that can be related to functional disorder of the orofacial system, such as multiple sclerosis, has been described from many aspects. Also, apart from the standard classification of one form of anterior displacement of the disc, made primarily by magnetic resonance, cases of disc displacement upon excursive mandibular movement can rarely be found in literature.

Correlation between olfactory dysfunction and various clinical parameters in patients with multiple sclerosis

Directory of Open Access Journals (Sweden)

Kostić Jelena

2009-01-01

Full Text Available Background/Aim. Multiple sclerosis (MS is a chronic inflammatory disease of the central nervous system (CNS characterized by myelin destruction and axon loss. Among various clinical manifestations of MS cognitive disorders are frequent. Olfactory disorders are also noticed but they are rarely considered in clinical practice. The aim of the present study was to examine frequency of olfactory dysfunction in patients with MS and its relationship to clinical parameters. Methods. Our study comprised 61 consecutive patients with definite MS who were hospitalized at the Department for Multiple Sclerosis and Other Immune- Mediated Disorders of CNS, Institute of Neurology, Clinical Center of Serbia, Belgrade, and 45 gender-, age- and education-matched healthy voluntaries. The Pocket Smell Test (PST was used for examination of olfactory function. Cognitive functions were analyzed using the tests from the Brief Battery of Neuropsychological Tests: Paced Auditory Serial Addition Test 3-minute Version (PASAT 3', Word List Generation (WLG and Symbol Digit Modalities Test (SDMT. Results. Olfactory dysfunction was found in 26 (43% MS patients and 5 (11% controls (p = 0.001. Statistically significant positive correlation was found only between PST score and WLG scores (r = 0.297, p = 0.030. In comparison with the previously published normative values, our subjects with MS had decrease in the mean indices of the PASAT 3' in 28%, SDMT in 51% and WLG in 90% of the subjects. Conclusion. Olfactory dysfunction is frequent in our population of patients with MS. This disturbance correlates with the impairment of cognitive functions in these patients.

[Multiple primary colorectal cancer: Clinical aspects].

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Soldatkina, N V; Kit, O I; Gevorkyan, Yu A; Milakin, A G

to define some clinical characteristics of synchronous and metachronous colorectal cancer (CRC). The investigation was concerned with the data of 150 patients with T1-4N0-2M0-1 multiple primary CRC. The clinical, biological, and morphological characteristics of synchronous and metachronous tumors were analyzed. Multiple primary tumors were 6.01% of all the cases of CRC. There was a preponderance of synchronous CRC (63.75%) with the tumor localized in the sigmoid colon and rectum. In women, synchronous colorectal tumors were more often concurrent with breast tumors; metachronous ones were detected after treatment for genital tumors. In men, synchronous colorectal tumors were more frequently concurrent with kidney cancer; metachronous ones were identified after treatment for gastric cancer. The found characteristics of multiple primary colorectal tumors may be taken in account in programs for both primary diagnosis and follow-up after treatment for malignant tumors, which will be able to improve the early detection of cancer patients and their treatment results.

Multiple sclerosis

International Nuclear Information System (INIS)

Sadashima, Hiromichi; Kusaka, Hirofumi; Imai, Terukuni; Takahashi, Ryosuke; Matsumoto, Sadayuki; Yamamoto, Toru; Yamasaki, Masahiro; Maya, Kiyomi

1986-01-01

Eleven patients with a definite diagnosis of multiple sclerosis were examined in terms of correlations between the clinical features and the results of cranial computed tomography (CT), and magnetic resonance imaging (MRI). Results: In 5 of the 11 patients, both CT and MRI demonstrated lesions consistent with a finding of multiple sclerosis. In 3 patients, only MRI demonstrated lesions. In the remaining 3 patients, neither CT nor MRI revealed any lesion in the brain. All 5 patients who showed abnormal findings on both CT and MRI had clinical signs either of cerebral or brainstem - cerebellar lesions. On the other hand, two of the 3 patients with normal CT and MRI findings had optic-nerve and spinal-cord signs. Therefore, our results suggested relatively good correlations between the clinical features, CT, and MRI. MRI revealed cerebral lesions in two of the four patients with clinical signs of only optic-nerve and spinal-cord lesions. MRI demonstrated sclerotic lesions in 3 of the 6 patients whose plaques were not detected by CT. In conclusion, MRI proved to be more helpful in the demonstration of lesions attributable to chronic multiple sclerosis. (author)

Defining the clinical course of multiple sclerosis

DEFF Research Database (Denmark)

Lublin, Fred D; Reingold, Stephen C; Cohen, Jeffrey A

2014-01-01

Accurate clinical course descriptions (phenotypes) of multiple sclerosis (MS) are important for communication, prognostication, design and recruitment of clinical trials, and treatment decision-making. Standardized descriptions published in 1996 based on a survey of international MS experts...

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

Directory of Open Access Journals (Sweden)

Belinda von Niederhäusern

Full Text Available To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research.We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes.Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives.Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality

Science.gov (United States)

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G.; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H.; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

Objective To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. Study design and setting We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Results Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Conclusion Clinical research quality is often discussed but rarely defined. A framework defining

Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection

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Qasmieh, Saba; Mounts, Anthony Wayne; Alexander, Burmaa; Besselaar, Terry; Briand, Sylvie; Brown, Caroline; Clark, Seth; Dueger, Erica; Gross, Diane; Hauge, Siri; Hirve, Siddhivinayak; Jorgensen, Pernille; Katz, Mark A; Mafi, Ali; Malik, Mamunur; McCarron, Margaret; Meerhoff, Tamara; Mori, Yuichiro; Mott, Joshua; Olivera, Maria Teresa da Costa; Ortiz, Justin R; Palekar, Rakhee; Rebelo-de-Andrade, Helena; Soetens, Loes; Yahaya, Ali Ahmed; Zhang, Wenqing; Vandemaele, Katelijn

2018-01-01

Abstract The formulation of accurate clinical case definitions is an integral part of an effective process of public health surveillance. Although such definitions should, ideally, be based on a standardized and fixed collection of defining criteria, they often require revision to reflect new knowledge of the condition involved and improvements in diagnostic testing. Optimal case definitions also need to have a balance of sensitivity and specificity that reflects their intended use. After the 2009–2010 H1N1 influenza pandemic, the World Health Organization (WHO) initiated a technical consultation on global influenza surveillance. This prompted improvements in the sensitivity and specificity of the case definition for influenza – i.e. a respiratory disease that lacks uniquely defining symptomology. The revision process not only modified the definition of influenza-like illness, to include a simplified list of the criteria shown to be most predictive of influenza infection, but also clarified the language used for the definition, to enhance interpretability. To capture severe cases of influenza that required hospitalization, a new case definition was also developed for severe acute respiratory infection in all age groups. The new definitions have been found to capture more cases without compromising specificity. Despite the challenge still posed in the clinical separation of influenza from other respiratory infections, the global use of the new WHO case definitions should help determine global trends in the characteristics and transmission of influenza viruses and the associated disease burden. PMID:29403115

Prediction of a multiple sclerosis diagnosis in patients with clinically isolated syndrome using the 2016 MAGNIMS and 2010 McDonald criteria: a retrospective study.

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Filippi, Massimo; Preziosa, Paolo; Meani, Alessandro; Ciccarelli, Olga; Mesaros, Sarlota; Rovira, Alex; Frederiksen, Jette; Enzinger, Christian; Barkhof, Frederik; Gasperini, Claudio; Brownlee, Wallace; Drulovic, Jelena; Montalban, Xavier; Cramer, Stig P; Pichler, Alexander; Hagens, Marloes; Ruggieri, Serena; Martinelli, Vittorio; Miszkiel, Katherine; Tintorè, Mar; Comi, Giancarlo; Dekker, Iris; Uitdehaag, Bernard; Dujmovic-Basuroski, Irena; Rocca, Maria A

2018-02-01

In 2016, the Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) network proposed modifications to the MRI criteria to define dissemination in space (DIS) and time (DIT) for the diagnosis of multiple sclerosis in patients with clinically isolated syndrome (CIS). Changes to the DIS definition included removal of the distinction between symptomatic and asymptomatic lesions, increasing the number of lesions needed to define periventricular involvement to three, combining cortical and juxtacortical lesions, and inclusion of optic nerve evaluation. For DIT, removal of the distinction between symptomatic and asymptomatic lesions was suggested. We compared the performance of the 2010 McDonald and 2016 MAGNIMS criteria for multiple sclerosis diagnosis in a large multicentre cohort of patients with CIS to provide evidence to guide revisions of multiple sclerosis diagnostic criteria. Brain and spinal cord MRI and optic nerve assessments from patients with typical CIS suggestive of multiple sclerosis done less than 3 months from clinical onset in eight European multiple sclerosis centres were included in this retrospective study. Eligible patients were 16-60 years, and had a first CIS suggestive of CNS demyelination and typical of relapsing-remitting multiple sclerosis, a complete neurological examination, a baseline brain and spinal cord MRI scan obtained less than 3 months from clinical onset, and a follow-up brain scan obtained less than 12 months from CIS onset. We recorded occurrence of a second clinical attack (clinically definite multiple sclerosis) at months 36 and 60. We evaluated MRI criteria performance for DIS, DIT, and DIS plus DIT with a time-dependent receiver operating characteristic curve analysis. Between June 16, 1995, and Jan 27, 2017, 571 patients with CIS were screened, of whom 368 met all study inclusion criteria. At the last evaluation (median 50·0 months [IQR 27·0-78·4]), 189 (51%) of 368 patients developed clinically definite multiple

Acute respiratory infection case definitions for young children: a systematic review of community-based epidemiologic studies in South Asia.

Science.gov (United States)

Roth, Daniel E; Gaffey, Michelle F; Smith-Romero, Evelyn; Fitzpatrick, Tiffany; Morris, Shaun K

2015-12-01

To explore the variability in childhood acute respiratory infection case definitions for research in low-income settings where there is limited access to laboratory or radiologic investigations. We conducted a systematic review of community-based, longitudinal studies in South Asia published from January 1990 to August 2013, in which childhood acute respiratory infection outcomes were reported. Case definitions were classified by their label (e.g. pneumonia, acute lower respiratory infection) and clinical content 'signatures' (array of clinical features that would be always present, conditionally present or always absent among cases). Case definition heterogeneity was primarily assessed by the number of unique case definitions overall and by label. We also compared case definition-specific acute respiratory infection incidence rates for studies reporting incidence rates for multiple case definitions. In 56 eligible studies, we found 124 acute respiratory infection case definitions. Of 90 case definitions for which clinical content was explicitly defined, 66 (73%) were unique. There was a high degree of content heterogeneity among case definitions with the same label, and some content signatures were assigned multiple labels. Within studies for which incidence rates were reported for multiple case definitions, variation in content was always associated with a change in incidence rate, even when the content differed by a single clinical feature. There has been a wide variability in case definition label and content combinations to define acute upper and lower respiratory infections in children in community-based studies in South Asia over the past two decades. These inconsistencies have important implications for the synthesis and translation of knowledge regarding the prevention and treatment of childhood acute respiratory infection. © 2015 John Wiley & Sons Ltd.

Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

DEFF Research Database (Denmark)

Schulman, S; Angerås, U; Bergqvist, D

2010-01-01

in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials...... of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols....

Continued Benefit to Androgen Deprivation Therapy for Prostate Cancer Patients Treated With Dose-Escalated Radiation Therapy Across Multiple Definitions of High-Risk Disease

International Nuclear Information System (INIS)

Stenmark, Matthew H.; Blas, Kevin; Halverson, Schuyler; Sandler, Howard M.; Feng, Felix Y.; Hamstra, Daniel A.

2011-01-01

Purpose: To analyze prognostic factors in patients with high-risk prostate cancer treated with dose-escalated external-beam radiation therapy (EBRT) and androgen deprivation (ADT). Methods and Materials: Between 1998 and 2008 at University of Michigan Medical Center, 718 men were consecutively treated with EBRT to at least 75 Gy. Seven definitions of high-risk prostate cancer, applying to 11–33% of patients, were evaluated. Biochemical failure (BF), salvage ADT use, metastatic progression, and prostate cancer–specific mortality (PCSM) were estimated by the Kaplan-Meier method and Cox proportional hazards regression. Results: Each high-risk definition was associated with increased BF (hazard ratio [HR] 2.8–3.9, p < 0.0001), salvage ADT use (HR 3.9–6.3, p < 0.0001), metastasis (HR 3.7–6.6, p < 0.0001), and PCSM (HR 3.7–16.2, p < 0.0001). Furthermore, an increasing number of high-risk features predicted worse outcome. Adjuvant ADT yielded significant reductions in both metastases (HR 0.19–0.38, p < 0.001) and PCSM (HR 0.38–0.50, p < 0.05) for all high-risk definitions (with the exception of clinical Stage T3–4 disease) but improved BF only for those with elevated Gleason scores (p < 0.03, HR 0.25–0.48). When treated with ADT and dose-escalated EBRT, patients with Gleason scores 8 to 10, without other high-risk features, had 8-year freedom from BF of 74%, freedom from distant metastases of 93%, and cause-specific survival of 92%, with salvage ADT used in 16% of patients. Conclusion: Adjuvant ADT results in a significant improvement in clinical progression and PCSM across multiple definitions of high-risk disease even with dose-escalated EBRT. There is a subset of patients, characterized by multiple high-risk features or the presence of Gleason Pattern 5, who remain at significant risk for metastasis and PCSM despite current treatment.

Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

Science.gov (United States)

Schulman, S; Angerås, U; Bergqvist, D; Eriksson, B; Lassen, M R; Fisher, W

2010-01-01

The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.

Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection.

NARCIS (Netherlands)

Fitzner, Julia; Qasmieh, Saba; Mounts, Anthony Wayne; Alexander, Burmaa; Besselaar, Terry; Briand, Sylvie; Brown, Caroline; Clark, Seth; Dueger, Erica; Gross, Diane; Hauge, Siri; Hirve, Siddhivinayak; Jorgensen, Pernille; Katz, Mark A; Mafi, Ali; Malik, Mamunur; McCarron, Margaret; Meerhoff, Tamara; Mori, Yuichiro; Mott, Joshua; Olivera, Maria Teresa da Costa; Ortiz, Justin R; Palekar, Rakhee; Rebelo-de-Andrade, Helena; Soetens, Loes; Yahaya, Ali Ahmed; Zhang, Wenqing; Vandemaele, Katelijn

2018-01-01

The formulation of accurate clinical case definitions is an integral part of an effective process of public health surveillance. Although such definitions should, ideally, be based on a standardized and fixed collection of defining criteria, they often require revision to reflect new knowledge of

What is a clinical pathway? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review

OpenAIRE

Lawal, Adegboyega K.; Rotter, Thomas; Kinsman, Leigh; Machotta, Andreas; Ronellenfitsch, Ulrich; Scott, Shannon D.; Goodridge, Donna; Plishka, Christopher; Groot, Gary

2016-01-01

textabstractClinical pathways (CPWs) are a common component in the quest to improve the quality of health. CPWs are used to reduce variation, improve quality of care, and maximize the outcomes for specific groups of patients. An ongoing challenge is the operationalization of a definition of CPW in healthcare. This may be attributable to both the differences in definition and a lack of conceptualization in the field of clinical pathways. This correspondence article describes a process of refin...

Evaluation of the WHO clinical case definition of AIDS among children in India.

Science.gov (United States)

Gurprit, Grover; Tripti, Pensi; Gadpayle, A K; Tanushree, Banerjee

2008-03-01

The need of a clinical case definition (CCD) for Acquired Immunodeficiency Syndrome (AIDS) was felt by public health agencies to monitor diseases resulting from human immunodeficiency virus (HIV) infection. To test the statistical significance of the existing World Health Organization (WHO) CCD for the diagnosis of AIDS in areas where diagnostic resources are limited in India, a prospective study was conducted in the Paediatrics department at Dr. Ram Manohar Lohia Hospital, New Delhi. 360 cases between 18 months-12 years of age satisfying WHO case definitions of AIDS were included in the study group. Informed consent was taken from the parents. The serum of patients was subjected to ELISA to conform the diagnosis of HIV infection. Our study detected 16.66% (60) of HIV prevalence in children visiting paediatrics outpatient clinic. 20% cases manifested 3 major and 2 minor signs. This definition had a sensitivity of 73.33%, specificity of 90.66%, positive predictive value (PPV) of 61.11% and negative predictive value (NPV) of 94.44%. On using stepwise logistic regression analysis weight loss, chronic fever > 1 month and total lymphocyte count of less than 1500 cells/mm3 emerged as important predictors. Cases showing 2 major and 2 minor signs were 86 (23.89%) with a sensitivity and specificity of 86.66% and 88.66% respectively. Based on these findings, we propose a clinical case definition based on 13 clinical signs and symptoms for paediatric AIDS in India with better sensitivity and PPV than the WHO case definition but with almost similar specificity. Thus multicentric studies are further required to modify these criteria in Indian set up.

Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition.

Science.gov (United States)

Cummings, Jeffrey; Mintzer, Jacobo; Brodaty, Henry; Sano, Mary; Banerjee, Sube; Devanand, D P; Gauthier, Serge; Howard, Robert; Lanctôt, Krista; Lyketsos, Constantine G; Peskind, Elaine; Porsteinsson, Anton P; Reich, Edgardo; Sampaio, Cristina; Steffens, David; Wortmann, Marc; Zhong, Kate

2015-01-01

Agitation is common across neuropsychiatric disorders and contributes to disability, institutionalization, and diminished quality of life for patients and their caregivers. There is no consensus definition of agitation and no widespread agreement on what elements should be included in the syndrome. The International Psychogeriatric Association formed an Agitation Definition Work Group (ADWG) to develop a provisional consensus definition of agitation in patients with cognitive disorders that can be applied in epidemiologic, non-interventional clinical, pharmacologic, non-pharmacologic interventional, and neurobiological studies. A consensus definition will facilitate communication and cross-study comparison and may have regulatory applications in drug development programs. The ADWG developed a transparent process using a combination of electronic, face-to-face, and survey-based strategies to develop a consensus based on agreement of a majority of participants. Nine-hundred twenty-eight respondents participated in the different phases of the process. Agitation was defined broadly as: (1) occurring in patients with a cognitive impairment or dementia syndrome; (2) exhibiting behavior consistent with emotional distress; (3) manifesting excessive motor activity, verbal aggression, or physical aggression; and (4) evidencing behaviors that cause excess disability and are not solely attributable to another disorder (psychiatric, medical, or substance-related). A majority of the respondents rated all surveyed elements of the definition as "strongly agree" or "somewhat agree" (68-88% across elements). A majority of the respondents agreed that the definition is appropriate for clinical and research applications. A provisional consensus definition of agitation has been developed. This definition can be used to advance interventional and non-interventional research of agitation in patients with cognitive impairment.

Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

DEFF Research Database (Denmark)

Kappos, Ludwig; Freedman, Mark S; Polman, Chris H

2009-01-01

with interferon beta-1b on time to clinically definite multiple sclerosis (CDMS) and other disease outcomes, including disability progression. METHODS: Patients with a first event suggestive of multiple sclerosis and a minimum of two clinically silent lesions in MRI were randomly assigned to receive interferon...... index (FAMS-TOI) at 5 years. Analysis of the primary endpoints was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00185211. FINDINGS: 235 (80%) patients from the early treatment and 123 (70%) from the delayed treatment group completed the 5-year study. Early treatment...

Application of the 2012 revised diagnostic definitions for paediatric multiple sclerosis and immune-mediated central nervous system demyelination disorders

NARCIS (Netherlands)

van Pelt, E. Danielle; Neuteboom, Rinze F.; Ketelslegers, Immy A.; Boon, Maartje; Catsman-Berrevoets, Coriene E.; Hintzen, Rogier Q.

Background Recently, the International Paediatric Multiple Sclerosis Study Group (IPMSSG) definitions for the diagnosis of immune-mediated acquired demyelinating syndromes (ADS) of the central nervous system, including paediatric multiple sclerosis (MS), have been revised. Objective To evaluate the

T1- Thresholds in Black Holes Increase Clinical-Radiological Correlation in Multiple Sclerosis Patients.

Science.gov (United States)

Thaler, Christian; Faizy, Tobias; Sedlacik, Jan; Holst, Brigitte; Stellmann, Jan-Patrick; Young, Kim Lea; Heesen, Christoph; Fiehler, Jens; Siemonsen, Susanne

2015-01-01

Magnetic Resonance Imaging (MRI) is an established tool in diagnosing and evaluating disease activity in Multiple Sclerosis (MS). While clinical-radiological correlations are limited in general, hypointense T1 lesions (also known as Black Holes (BH)) have shown some promising results. The definition of BHs is very heterogeneous and depends on subjective visual evaluation. We aimed to improve clinical-radiological correlations by defining BHs using T1 relaxation time (T1-RT) thresholds to achieve best possible correlation between BH lesion volume and clinical disability. 40 patients with mainly relapsing-remitting MS underwent MRI including 3-dimensional fluid attenuated inversion recovery (FLAIR), magnetization-prepared rapid gradient echo (MPRAGE) before and after Gadolinium (GD) injection and double inversion-contrast magnetization-prepared rapid gradient echo (MP2RAGE) sequences. BHs (BHvis) were marked by two raters on native T1-weighted (T1w)-MPRAGE, contrast-enhancing lesions (CE lesions) on T1w-MPRAGE after GD and FLAIR lesions (total-FLAIR lesions) were detected separately. BHvis and total-FLAIR lesion maps were registered to MP2RAGE images, and the mean T1-RT were calculated for all lesion ROIs. Mean T1 values of the cortex (CTX) were calculated for each patient. Subsequently, Spearman rank correlations between clinical scores (Expanded Disability Status Scale and Multiple Sclerosis Functional Composite) and lesion volume were determined for different T1-RT thresholds. Significant differences in T1-RT were obtained between all different lesion types with highest T1 values in visually marked BHs (BHvis: 1453.3±213.4 ms, total-FLAIR lesions: 1394.33±187.38 ms, CTX: 1305.6±35.8 ms; p1500 ms (Expanded Disability Status Scale vs. lesion volume: rBHvis = 0.442 and rtotal-FLAIR = 0.497, p<0.05; Multiple Sclerosis Functional Composite vs. lesion volume: rBHvis = -0.53 and rtotal-FLAIR = -0.627, p<0.05). Clinical-radiological correlations in MS patients are

Clinical Criteria Versus a Possible Research Case Definition in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.

Science.gov (United States)

Jason, Leonard A; McManimen, Stephanie; Sunnquist, Madison; Newton, Julia L; Strand, Elin Bolle

2017-01-01

The Institute of Medicine (IOM) recently developed clinical criteria for what had been known as chronic fatigue syndrome (CFS). Given the broad nature of the clinical IOM criteria, there is a need for a research definition that would select a more homogenous and impaired group of patients than the IOM clinical criteria. At the present time, it is unclear what will serve as the research definition. The current study focused on a research definition which selected homebound individuals who met the four IOM criteria, excluding medical and psychiatric co-morbidities. Our research criteria were compared to those participants meeting the IOM criteria. Those not meeting either of these criteria sets were placed in a separate group defined by 6 or more months of fatigue. Data analyzed were from the DePaul Symptom Questionnaire and the SF-36. Due to unequal sample sizes and variances, Welch's F tests and Games-Howell post hoc tests were conducted. Using a large database of over 1,000 patients from several countries, we found that those meeting a more restrictive research definition were even more impaired and more symptomatic than those meeting criteria for the other two groups. Deciding on a particular research case definition would allow researchers to select more comparable patient samples across settings, and this would represent one of the most significant methodologic advances for this field of study.

Sample size determination in clinical trials with multiple endpoints

CERN Document Server

Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R

2015-01-01

This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...

Consensus definitions and application guidelines for control groups in cerebrospinal fluid biomarker studies in multiple sclerosis

DEFF Research Database (Denmark)

Teunissen, Charlotte; Menge, Til; Altintas, Ayse

2013-01-01

The choice of appropriate control group(s) is critical in cerebrospinal fluid (CSF) biomarker research in multiple sclerosis (MS). There is a lack of definitions and nomenclature of different control groups and a rationalized application of different control groups. We here propose consensus......). Furthermore, we discuss the application of these control groups in specific study designs, such as for diagnostic biomarker studies, prognostic biomarker studies and therapeutic response studies. Application of these uniform definitions will lead to better comparability of biomarker studies and optimal use...

Oligometastatic prostate cancer: definitions, clinical outcomes, and treatment considerations

Science.gov (United States)

Tosoian, Jeffrey J.; Gorin, Michael A.; Ross, Ashley E.; Pienta, Kenneth J.; Tran, Phuoc T.; Schaeffer, Edward M.

2018-01-01

The oligometastatic state has been proposed as an intermediate stage of cancer spread between localized disease and widespread metastases. With improvements in diagnostic modalities such as functional imaging, oligometastatic prostate cancer is being diagnosed with greater frequency than ever before. Furthermore, the paradigm for treatment of advanced prostate cancers is shifting toward a more aggressive approach. Many questions surround the understanding of the process and consequences of oligometastasis, meaning that the contemporary literature offers a wide variety of definitions of oligometastatic prostate cancer. Until genomic data exist to provide a biological component to the definition of oligometastatic disease, a clinical diagnosis made on the basis of up to five extrapelvic lesions is reasonable for use. Retrospective studies suggest that interventions such as radical prostatectomy and local or metastasis-directed radiotherapy can be performed in the metastatic setting with minimal risk of toxic effects. These therapies seem to decrease the need for subsequent palliative interventions, but insufficient data are available to draw reliable conclusions regarding their effect on survival. Thus, a protocol for clinicians to manage the patient presenting with oligometastatic prostate cancer would be a useful clinical tool. PMID:27725639

Improving Clinical Trial Cohort Definition Criteria and Enrollment with Distributional Semantic Matching

OpenAIRE

Shao, Jianyin; Gouripeddi, Ramkiran; Facelli, Julio C.

2016-01-01

Shao, J., Gouripeddi, R., & Facelli, J.C. (2016). Improving Clinical Trial Cohort Definition Criteria and Enrollment with Distributional Semantic Matching (poster). Research Reproducibility 2016. Salt Lake City, UT, USA

Validation of clinical case definition of acute intussusception in infants in Viet Nam and Australia.

Science.gov (United States)

Bines, Julie E; Liem, Nguyen Thanh; Justice, Frances; Son, Tran Ngoc; Carlin, John B; de Campo, Margaret; Jamsen, Kris; Mulholland, Kim; Barnett, Peter; Barnes, Graeme L

2006-07-01

To test the sensitivity and specificity of a clinical case definition of acute intussusception in infants to assist health-care workers in settings where diagnostic facilities are not available. Prospective studies were conducted at a major paediatric hospital in Viet Nam (the National Hospital of Pediatrics, Hanoi) from November 2002 to December 2003 and in Australia (the Royal Children's Hospital, Melbourne) from March 2002 to March 2004 using a clinical case definition of intussusception. Diagnosis of intussusception was confirmed by air enema or surgery and validated in a subset of participants by an independent clinician who was blinded to the participant's status. Sensitivity of the definition was evaluated in 584 infants agedclinical features consistent with intussusception but for whom another diagnosis was established (234 infants in Hanoi; 404 in Melbourne). In both locations the definition used was sensitive (96% sensitivity in Hanoi; 98% in Melbourne) and specific (95% specificity in Hanoi; 87% in Melbourne) for intussusception among infants with sufficient data to allow classification (449/533 in Hanoi; 50/51 in Melbourne). Reanalysis of patients with missing data suggests that modifying minor criteria would increase the applicability of the definition while maintaining good sensitivity (96-97%) and specificity (83-89%). The clinical case definition was sensitive and specific for the diagnosis of acute intussusception in infants in both a developing country and a developed country but minor modifications would enable it to be used more widely.

Validation of clinical case definition of acute intussusception in infants in Viet Nam and Australia.

OpenAIRE

Bines, JE; Liem, NT; Justice, F; Son, TN; Carlin, JB; de Campo, M; Jamsen, K; Mulholland, K; Barnett, P; Barnes, GL

2006-01-01

OBJECTIVE: To test the sensitivity and specificity of a clinical case definition of acute intussusception in infants to assist health-care workers in settings where diagnostic facilities are not available. METHODS: Prospective studies were conducted at a major paediatric hospital in Viet Nam (the National Hospital of Pediatrics, Hanoi) from November 2002 to December 2003 and in Australia (the Royal Children's Hospital, Melbourne) from March 2002 to March 2004 using a clinical case definition ...

Osteoporosis-related fracture case definitions for population-based administrative data

Directory of Open Access Journals (Sweden)

Lix Lisa M

2012-05-01

Full Text Available Abstract Background Population-based administrative data have been used to study osteoporosis-related fracture risk factors and outcomes, but there has been limited research about the validity of these data for ascertaining fracture cases. The objectives of this study were to: (a compare fracture incidence estimates from administrative data with estimates from population-based clinically-validated data, and (b test for differences in incidence estimates from multiple administrative data case definitions. Methods Thirty-five case definitions for incident fractures of the hip, wrist, humerus, and clinical vertebrae were constructed using diagnosis codes in hospital data and diagnosis and service codes in physician billing data from Manitoba, Canada. Clinically-validated fractures were identified from the Canadian Multicentre Osteoporosis Study (CaMos. Generalized linear models were used to test for differences in incidence estimates. Results For hip fracture, sex-specific differences were observed in the magnitude of under- and over-ascertainment of administrative data case definitions when compared with CaMos data. The length of the fracture-free period to ascertain incident cases had a variable effect on over-ascertainment across fracture sites, as did the use of imaging, fixation, or repair service codes. Case definitions based on hospital data resulted in under-ascertainment of incident clinical vertebral fractures. There were no significant differences in trend estimates for wrist, humerus, and clinical vertebral case definitions. Conclusions The validity of administrative data for estimating fracture incidence depends on the site and features of the case definition.

Accuracy of clinical diagnosis versus the World Health Organization case definition in the Amoy Garden SARS cohort.

Science.gov (United States)

Wong, W N; Sek, Antonio C H; Lau, Rick F L; Li, K M; Leung, Joe K S; Tse, M L; Ng, Andy H W; Stenstrom, Robert

2003-11-01

To compare the diagnostic accuracy of emergency department (ED) physicians with the World Health Organization (WHO) case definition in a large community-based SARS (severe acute respiratory syndrome) cohort. This was a cohort study of all patients from Hong Kong's Amoy Garden complex who presented to an ED SARS screening clinic during a 2-month outbreak. Clinical findings and WHO case definition criteria were recorded, along with ED diagnoses. Final diagnoses were established independently based on relevant diagnostic tests performed after the ED visit. Emergency physician diagnostic accuracy was compared with that of the WHO SARS case definition. Sensitivity, specificity, predictive values and likelihood ratios were calculated using standard formulae. During the study period, 818 patients presented with SARS-like symptoms, including 205 confirmed SARS, 35 undetermined SARS and 578 non-SARS. Sensitivity, specificity and accuracy were 91%, 96% and 94% for ED clinical diagnosis, versus 42%, 86% and 75% for the WHO case definition. Positive likelihood ratios (LR+) were 21.1 for physician judgement and 3.1 for the WHO criteria. Negative likelihood ratios (LR-) were 0.10 for physician judgement and 0.67 for the WHO criteria, indicating that clinician judgement was a much more powerful predictor than the WHO criteria. Physician clinical judgement was more accurate than the WHO case definition. Reliance on the WHO case definition as a SARS screening tool may lead to an unacceptable rate of misdiagnosis. The SARS case definition must be revised if it is to be used as a screening tool in emergency departments and primary care settings.

CHRONIC OBSTRUCTIVE PULMONARY DISEASE: DEFINITION, EPIDEMIOLOGY, PATHOPHYSIOLOGY, CLINICAL PICTURE AND TREATMENT (GOLD 2013

Directory of Open Access Journals (Sweden)

M. T. Vatutin

2015-01-01

Full Text Available Chronic obstructive pulmonary disease: definition, epidemiology, pathophysiology, clinical picture (GOLD 2013. Vatutin M.T., Smyrnova G.S., Taradin G.G. The represented translation of the new international guidelines (GOLD 2013 reflected the epidemiology, pathophysiology, clinical picture and treatment of chronic obstructive pulmonary disease.

What is a clinical pathway? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review.

Science.gov (United States)

Lawal, Adegboyega K; Rotter, Thomas; Kinsman, Leigh; Machotta, Andreas; Ronellenfitsch, Ulrich; Scott, Shannon D; Goodridge, Donna; Plishka, Christopher; Groot, Gary

2016-02-23

Clinical pathways (CPWs) are a common component in the quest to improve the quality of health. CPWs are used to reduce variation, improve quality of care, and maximize the outcomes for specific groups of patients. An ongoing challenge is the operationalization of a definition of CPW in healthcare. This may be attributable to both the differences in definition and a lack of conceptualization in the field of clinical pathways. This correspondence article describes a process of refinement of an operational definition for CPW research and proposes an operational definition for the future syntheses of CPWs literature. Following the approach proposed by Kinsman et al. (BMC Medicine 8(1):31, 2010) and Wieland et al. (Alternative Therapies in Health and Medicine 17(2):50, 2011), we used a four-stage process to generate a five criteria checklist for the definition of CPWs. We refined the operational definition, through consensus, merging two of the checklist's criteria, leading to a more inclusive criterion for accommodating CPW studies conducted in various healthcare settings. The following four criteria for CPW operational definition, derived from the refinement process described above, are (1) the intervention was a structured multidisciplinary plan of care; (2) the intervention was used to translate guidelines or evidence into local structures; (3) the intervention detailed the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol or other 'inventory of actions' (i.e. the intervention had time-frames or criteria-based progression); and (4) the intervention aimed to standardize care for a specific population. An intervention meeting all four criteria was considered to be a CPW. The development of operational definitions for complex interventions is a useful approach to appraise and synthesize evidence for policy development and quality improvement.

Clinical case review: a method to improve identification of true clinical and radiographic pneumonia in children meeting the World Health Organization definition for pneumonia.

Science.gov (United States)

Puumalainen, Taneli; Quiambao, Beatriz; Abucejo-Ladesma, Erma; Lupisan, Socorro; Heiskanen-Kosma, Tarja; Ruutu, Petri; Lucero, Marilla G; Nohynek, Hanna; Simoes, Eric A F; Riley, Ian

2008-07-21

The World Health Organization's (WHO) case definition for childhood pneumonia, composed of simple clinical signs of cough, difficult breathing and fast breathing, is widely used in resource poor settings to guide management of acute respiratory infections. The definition is also commonly used as an entry criteria or endpoint in different intervention and disease burden studies. A group of paediatricians conducted a retrospective review of clinical and laboratory data including C-reactive protein concentration and chest radiograph findings among Filipino children hospitalised in the Bohol Regional Hospital who were enrolled in a pneumococcal vaccine efficacy study and had an episode of respiratory disease fulfilling the WHO case definition for clinical pneumonia. Our aim was to evaluate which disease entities the WHO definition actually captures and what is the probable aetiology of respiratory infections among these episodes diagnosed in this population. Among the 12,194 children enrolled to the vaccine study we recorded 1,195 disease episodes leading to hospitalisation which fulfilled the WHO criteria for pneumonia. In total, 34% of these episodes showed radiographic evidence of pneumonia and 11% were classified as definitive or probable bacterial pneumonia. Over 95% of episodes of WHO-defined severe pneumonia (with chest indrawing) had an acute lower respiratory infection as final diagnosis whereas 34% of those with non-severe clinical pneumonia had gastroenteritis or other non-respiratory infection as main cause of hospitalisation. The WHO definition for severe pneumonia shows high specificity for acute lower respiratory infection and provides a tool to compare the total burden of lower respiratory infections in different settings. ISRCTN62323832.

Hypophosphatemic osteomalacia: an unusual clinical presentation of multiple myeloma.

Science.gov (United States)

Reyskens, M; Sleurs, K; Verresen, L; Janssen, M; van den Bergh, J; van den Berg, J; Geusens, P

2015-07-01

An unusual case of a 75-year-old man is presented who had multiple stress fractures due to adult onset hypophosphatemic osteomalacia, which was the result of Fanconi syndrome, with light chain cast proximal tubulopathy due to multiple myeloma. A 75-year-old man presented with diffuse pain and muscle weakness. He had multiple stress fractures, low serum phosphate, decreased renal tubular reabsorption of phosphate, and normal PTH and FGF23, indicating adult onset hypophosphatemic osteomalacia. Phosphate supplements with calcitriol resulted in clinical recovery and healing of stress fractures. Because of proteinuria, a renal biopsy was performed that revealed Fanconi syndrome with light chain cast proximal tubulopathy and light kappa chains were found in serum and urine. A bone biopsy confirmed the diagnosis of multiple myeloma, and treatment with chemotherapy resulted in cytological and clinical recovery.

Proposed clinical case definition for cytomegalovirus-immune recovery retinitis.

Science.gov (United States)

Ruiz-Cruz, Matilde; Alvarado-de la Barrera, Claudia; Ablanedo-Terrazas, Yuria; Reyes-Terán, Gustavo

2014-07-15

Cytomegalovirus (CMV) retinitis has been extensively described in patients with advanced or late human immunodeficiency virus (HIV) disease under ineffective treatment of opportunistic infection and antiretroviral therapy (ART) failure. However, there is limited information about patients who develop active cytomegalovirus retinitis as an immune reconstitution inflammatory syndrome (IRIS) after successful initiation of ART. Therefore, a case definition of cytomegalovirus-immune recovery retinitis (CMV-IRR) is proposed here. We reviewed medical records of 116 HIV-infected patients with CMV retinitis attending our institution during January 2003-June 2012. We retrospectively studied HIV-infected patients who had CMV retinitis on ART initiation or during the subsequent 6 months. Clinical and immunological characteristics of patients with active CMV retinitis were described. Of the 75 patients under successful ART included in the study, 20 had improvement of CMV retinitis. The remaining 55 patients experienced CMV-IRR; 35 of those developed CMV-IRR after ART initiation (unmasking CMV-IRR) and 20 experienced paradoxical clinical worsening of retinitis (paradoxical CMV-IRR). Nineteen patients with CMV-IRR had a CD4 count of ≥50 cells/µL. Six patients with CMV-IRR subsequently developed immune recovery uveitis. There is no case definition for CMV-IRR, although this condition is likely to occur after successful initiation of ART, even in patients with high CD4 T-cell counts. By consequence, we propose the case definitions for paradoxical and unmasking CMV-IRR. We recommend close follow-up of HIV-infected patients following ART initiation. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Developing a New Definition and Assessing New Clinical Criteria for Septic Shock For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

NARCIS (Netherlands)

Shankar-Hari, Manu; Phillips, Gary S.; Levy, Mitchell L.; Seymour, Christopher W.; Liu, Vincent X.; Deutschman, Clifford S.; Angus, Derek C.; Rubenfeld, Gordon D.; Singer, Mervyn; Angus, Derek; Annane, Djilalli; Bauer, Michael; Bellomo, Rinaldo; Bernard, Gordon; Chiche, Jean-Daniel; Coopersmith, Craig; Deutschman, Cliff; Hotchkiss, Richard; Levy, Mitchell; Marshall, John; Martin, Greg; Opal, Steve; Rubenfeld, Gordon; Seymour, Christopher; van der Poll, Tom; Vincent, Jean-Louis

2016-01-01

IMPORTANCE Septic shock currently refers to a state of acute circulatory failure associated with infection. Emerging biological insights and reported variation in epidemiology challenge the validity of this definition. OBJECTIVE To develop a new definition and clinical criteria for identifying

Diagnosis of measles by clinical case definition in dengue-endemic areas: implications for measles surveillance and control.

OpenAIRE

Dietz, V. J.; Nieburg, P.; Gubler, D. J.; Gomez, I.

1992-01-01

In many countries, measles surveillance relies heavily on the use of a standard clinical case definition; however, the clinical signs and symptoms of measles are similar to those of dengue. For example, during 1985, in Puerto Rico, 22 (23%) of 94 cases of illnesses with rashes that met the measles clinical case definition were serologically confirmed as measles, but 32 (34%) others were serologically confirmed as dengue. Retrospective analysis at the San Juan Laboratories of the Centers for D...

Cognitive deficits in multiple sclerosis

DEFF Research Database (Denmark)

Lund, H; Jønsson, A; Andresen, Jesper Graubæk

2012-01-01

of the cognitive impairment seen in MS and constitute a supplement to traditional measurement of T2 lesion volume. Materials and Methods - Fifty patients with clinically definite MS were included (38 women, 12 men). Patients were MR scanned, neuropsychologically tested, and evaluated clinically with the Kurtzke......Objectives - Although disease load in multiple sclerosis (MS) often is based on T2 lesion volumes, the changes in T2 of normal appearing brain tissue (NABT) are rarely considered. By means of magnetic resonance, (MR) we retrospectively investigated whether T2 changes in NABT explain part...... Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Impairment Scale (MSIS). Voxel-wise T2 estimates and total T2 lesion volume were tested for correlations with eight cognitive domains, a general cognitive dysfunction factor (CDF), and the two clinical scales. Results - We found distinct...

Retroillumination photography analysis enhances clinical definition of severe Fuchs Corneal Dystrophy

Science.gov (United States)

Eghrari, Allen O.; Garrett, Brian S.; Mumtaz, Aisha A.; Edalati, Armand E.; Meadows, Danielle N.; McGlumphy, Elyse J.; Iliff, Benjamin W.; Gottsch, John D.

2015-01-01

Purpose Retroillumination photography analysis (RPA) provides objective assessment of the number and distribution of guttae in Fuchs Corneal Dystrophy. Here, we assess its correlation with clinical grading using slit-lamp biomicroscopy across varying levels of severity. Methods Retroillumination photographs were conducted of 95 affected corneas with slit-lamp flash photography after pupillary dilation. Individual guttae were counted manually and the position of individual points recorded. Clinical grading using the Krachmer scale was documented for each eye during examination, and regression analyses were performed to identify the strength of association with number of guttae. We assessed range at each stage of clinical grading, and utilized the Mann-Whitney U test to assess whether clinical grading levels demonstrated successively higher numbers of guttae. Results Krachmer score ranged from 1 to 5, with mean of 2.6. Mean numbers of guttae at each level of severity were 289 (1+), 999 (2+), 2669 (3+), 5474 (4+), and 7133 (5+). Each stage demonstrated significantly higher numbers of guttae than its preceding level except from 4+ to 5+ (p=0.30), consistent with the definition of 4+ as the highest level defined by presence of guttae. Higher levels of clinical grading were associated with larger ranges of guttae (p<0.01). A linear regression model resulted in a strong fit between RPA and Krachmer score (r=0.81). Conclusion In this largest study of RPA data and comparison with subjective clinical grading of FCD severity, RPA correlates strongly and demonstrates enhanced definition of severity at advanced stages of disease. PMID:26488628

Clinical case review: A method to improve identification of true clinical and radiographic pneumonia in children meeting the World Health Organization definition for pneumonia

OpenAIRE

Puumalainen, Taneli; Quiambao, Beatriz; Abucejo-Ladesma, Erma; Lupisan, Socorro; Heiskanen-Kosma, Tarja; Ruutu, Petri; Lucero, Marilla G; Nohynek, Hanna; Simoes, Eric AF; Riley, Ian

2008-01-01

Abstract Background The World Health Organization's (WHO) case definition for childhood pneumonia, composed of simple clinical signs of cough, difficult breathing and fast breathing, is widely used in resource poor settings to guide management of acute respiratory infections. The definition is also commonly used as an entry criteria or endpoint in different intervention and disease burden studies. Methods A group of paediatricians conducted a retrospective review of clinical and laboratory da...

Clinical case review: A method to improve identification of true clinical and radiographic pneumonia in children meeting the World Health Organization definition for pneumonia

Directory of Open Access Journals (Sweden)

Ruutu Petri

2008-07-01

Full Text Available Abstract Background The World Health Organization's (WHO case definition for childhood pneumonia, composed of simple clinical signs of cough, difficult breathing and fast breathing, is widely used in resource poor settings to guide management of acute respiratory infections. The definition is also commonly used as an entry criteria or endpoint in different intervention and disease burden studies. Methods A group of paediatricians conducted a retrospective review of clinical and laboratory data including C-reactive protein concentration and chest radiograph findings among Filipino children hospitalised in the Bohol Regional Hospital who were enrolled in a pneumococcal vaccine efficacy study and had an episode of respiratory disease fulfilling the WHO case definition for clinical pneumonia. Our aim was to evaluate which disease entities the WHO definition actually captures and what is the probable aetiology of respiratory infections among these episodes diagnosed in this population. Results Among the 12,194 children enrolled to the vaccine study we recorded 1,195 disease episodes leading to hospitalisation which fulfilled the WHO criteria for pneumonia. In total, 34% of these episodes showed radiographic evidence of pneumonia and 11% were classified as definitive or probable bacterial pneumonia. Over 95% of episodes of WHO-defined severe pneumonia (with chest indrawing had an acute lower respiratory infection as final diagnosis whereas 34% of those with non-severe clinical pneumonia had gastroenteritis or other non-respiratory infection as main cause of hospitalisation. Conclusion The WHO definition for severe pneumonia shows high specificity for acute lower respiratory infection and provides a tool to compare the total burden of lower respiratory infections in different settings. Trial registration ISRCTN62323832

Hantavirus pulmonary syndrome clinical findings: evaluating a surveillance case definition.

Science.gov (United States)

Knust, Barbara; Macneil, Adam; Rollin, Pierre E

2012-05-01

Clinical cases of hantavirus pulmonary syndrome (HPS) can be challenging to differentiate from other acute respiratory diseases, which can lead to delays in diagnosis, treatment, and disease reporting. Rapid onset of severe disease occurs, at times before diagnostic test results are available. This study's objective was to examine the clinical characteristics of patients that would indicate HPS to aid in detection and reporting. Test results of blood samples from U.S. patients suspected of having HPS submitted to the Centers for Disease Control and Prevention from 1998-2010 were reviewed. Patient information collected by case report forms was compared between HPS-confirmed and test-negative patients. Diagnostic sensitivity, specificity, predictive values, and likelihood ratios were calculated for individual clinical findings and combinations of variables. Of 567 patients included, 36% were HPS-confirmed. Thrombocytopenia, chest x-rays with suggestive signs, and receiving supplemental oxygenation were highly sensitive (>95%), while elevated hematocrit was highly specific (83%) in detecting HPS. Combinations that maximized sensitivity required the presence of thrombocytopenia. Using a national sample of suspect patients, we found that thrombocytopenia was a highly sensitive indicator of HPS and should be included in surveillance definitions for suspected HPS. Using a sensitive suspect case definition to identify potential HPS patients that are confirmed by highly specific diagnostic testing will ensure accurate reporting of this disease.

Consensus Guidelines for Delineation of Clinical Target Volume for Intensity-Modulated Pelvic Radiotherapy for the Definitive Treatment of Cervix Cancer

International Nuclear Information System (INIS)

Lim, Karen; Small, William; Portelance, Lorraine; Creutzberg, Carien; Juergenliemk-Schulz, Ina M.; Mundt, Arno; Mell, Loren K.; Mayr, Nina; Viswanathan, Akila; Jhingran, Anuja; Erickson, Beth; De Los Santos, Jennifer; Gaffney, David; Yashar, Catheryn; Beriwal, Sushil; Wolfson, Aaron

2011-01-01

Purpose: Accurate target definition is vitally important for definitive treatment of cervix cancer with intensity-modulated radiotherapy (IMRT), yet a definition of clinical target volume (CTV) remains variable within the literature. The aim of this study was to develop a consensus CTV definition in preparation for a Phase 2 clinical trial being planned by the Radiation Therapy Oncology Group. Methods and Materials: A guidelines consensus working group meeting was convened in June 2008 for the purposes of developing target definition guidelines for IMRT for the intact cervix. A draft document of recommendations for CTV definition was created and used to aid in contouring a clinical case. The clinical case was then analyzed for consistency and clarity of target delineation using an expectation maximization algorithm for simultaneous truth and performance level estimation (STAPLE), with kappa statistics as a measure of agreement between participants. Results: Nineteen experts in gynecological radiation oncology generated contours on axial magnetic resonance images of the pelvis. Substantial STAPLE agreement sensitivity and specificity values were seen for gross tumor volume (GTV) delineation (0.84 and 0.96, respectively) with a kappa statistic of 0.68 (p < 0.0001). Agreement for delineation of cervix, uterus, vagina, and parametria was moderate. Conclusions: This report provides guidelines for CTV definition in the definitive cervix cancer setting for the purposes of IMRT, building on previously published guidelines for IMRT in the postoperative setting.

Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

Science.gov (United States)

Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

2010-10-01

In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

Variation in the Definition of Clinical Target Volumes for Pelvic Nodal Conformal Radiation Therapy for Prostate Cancer

International Nuclear Information System (INIS)

Lawton, Colleen A.F.; Michalski, Jeff; El-Naqa, Issam; Kuban, Deborah; Lee, W. Robert; Rosenthal, Seth A.; Zietman, Anthony; Sandler, Howard; Shipley, William; Ritter, Mark; Valicenti, Richard; Catton, Charles; Roach, Mack; Pisansky, Thomas M.; Seider, Michael

2009-01-01

Purpose: We conducted a comparative study of clinical target volume (CTV) definition of pelvic lymph nodes by multiple genitourinary (GU) radiation oncologists looking at the levels of discrepancies amongst this group. Methods and Materials: Pelvic computed tomography (CT) scans from 2 men were distributed to 14 Radiation Therapy Oncology Group GU radiation oncologists with instructions to define CTVs for the iliac and presacral lymph nodes. The CT data with contours were then returned for analysis. In addition, a questionnaire was completed that described the physicians' method for target volume definition. Results: Significant variation in the definition of the iliac and presacral CTVs was seen among the physicians. The minimum, maximum, mean (SD) iliac volumes (mL) were 81.8, 876.6, 337.6 ± 203 for case 1 and 60.3, 627.7, 251.8 ± 159.3 for case 2. The volume of 100% agreement was 30.6 and 17.4 for case 1 and 2 and the volume of the union of all contours was 1,012.0 and 807.4 for case 1 and 2, respectively. The overall agreement was judged to be moderate in both cases (kappa = 0.53 (p < 0.0001) and kappa = 0.48 (p < 0.0001). There was no volume of 100% agreement for either of the two presacral volumes. These variations were confirmed in the responses to the associated questionnaire. Conclusions: Significant disagreement exists in the definition of the CTV for pelvic nodal radiation therapy among GU radiation oncology specialists. A consensus needs to be developed so as to accurately assess the merit and safety of such treatment.

A Framework for the Development and Interpretation of Different Sepsis Definitions and Clinical Criteria.

Science.gov (United States)

Angus, Derek C; Seymour, Christopher W; Coopersmith, Craig M; Deutschman, Clifford S; Klompas, Michael; Levy, Mitchell M; Martin, Gregory S; Osborn, Tiffany M; Rhee, Chanu; Watson, R Scott

2016-03-01

Although sepsis was described more than 2,000 years ago, and clinicians still struggle to define it, there is no "gold standard," and multiple competing approaches and terms exist. Challenges include the ever-changing knowledge base that informs our understanding of sepsis, competing views on which aspects of any potential definition are most important, and the tendency of most potential criteria to be distributed in at-risk populations in such a way as to hinder separation into discrete sets of patients. We propose that the development and evaluation of any definition or diagnostic criteria should follow four steps: 1) define the epistemologic underpinning, 2) agree on all relevant terms used to frame the exercise, 3) state the intended purpose for any proposed set of criteria, and 4) adopt a scientific approach to inform on their usefulness with regard to the intended purpose. Usefulness can be measured across six domains: 1) reliability (stability of criteria during retesting, between raters, over time, and across settings), 2) content validity (similar to face validity), 3) construct validity (whether criteria measure what they purport to measure), 4) criterion validity (how new criteria fare compared to standards), 5) measurement burden (cost, safety, and complexity), and 6) timeliness (whether criteria are available concurrent with care decisions). The relative importance of these domains of usefulness depends on the intended purpose, of which there are four broad categories: 1) clinical care, 2) research, 3) surveillance, and 4) quality improvement and audit. This proposed methodologic framework is intended to aid understanding of the strengths and weaknesses of different approaches, provide a mechanism for explaining differences in epidemiologic estimates generated by different approaches, and guide the development of future definitions and diagnostic criteria.

Of Atkins and men: deviations from clinical definitions of mental retardation in death penalty cases.

Science.gov (United States)

Blume, John H; Johnson, Sheri Lynn; Seeds, Christopher

2009-01-01

Under Atkins v. Virginia, the Eighth Amendment exempts from execution individuals who meet the clinical definitions of mental retardation set forth by the American Association on Intellectual and Developmental Disabilities and the American Psychiatric Association. Both define mental retardation as significantly subaverage intellectual functioning accompanied by significant limitations in adaptive functioning, originating before the age of 18. Since Atkins, most jurisdictions have adopted definitions of mental retardation that conform to those definitions. But some states, looking often to stereotypes of persons with mental retardation, apply exclusion criteria that deviate from and are more restrictive than the accepted scientific and clinical definitions. These state deviations have the effect of excluding from Atkins's reach some individuals who plainly fall within the class it protects. This article focuses on the cases of Roger Cherry, Jeffrey Williams, Michael Stallings, and others, who represent an ever-growing number of individuals inappropriately excluded from Atkins. Left unaddressed, the state deviations discussed herein permit what Atkins does not: the death-sentencing and execution of some capital defendants who have mental retardation.

Clinical Application of 18F-FDG PET in Multiple Myeloma

International Nuclear Information System (INIS)

Lee, Su Jin; Choi, Joon Young

2009-01-01

This review focuses on the clinical use of 18 F-FDG PET to evaluate multiple myeloma. 18 F-FDG PET is useful for diagnosis, staging of multiple myeloma and differential diagnosis of myeloma related disease such as monoclonal gammopathy of undetermined significance or plasmacytoma. For therapy response, 18 F-FDG PET may be effective after chemotherapy for multiple myeloma and radiotherapy for plasmacytoma

Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

DEFF Research Database (Denmark)

Schulman, S; Angerås, U; Bergqvist, D

2010-01-01

subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used......The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its...... in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials...

Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel.

Science.gov (United States)

Graham, Stephen M; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E; Gale, Marianne; Gie, Robert P; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J; McNeeley, David F; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R; Swaminathan, Soumya; Wingfield, Claire

2012-05-15

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis.

Evaluation of Tuberculosis Diagnostics in Children: 1. Proposed Clinical Case Definitions for Classification of Intrathoracic Tuberculosis Disease. Consensus From an Expert Panel

Science.gov (United States)

Graham, Stephen M.; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E.; Gale, Marianne; Gie, Robert P.; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C.; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J.; McNeeley, David F.; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R.; Swaminathan, Soumya; Wingfield, Claire

2012-01-01

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis. PMID:22448023

Study on the clinical usefulness of magnetic resonance imaging in cases of multiple cerebral infarction

International Nuclear Information System (INIS)

Miyashita, Kotaro

1991-01-01

The clinical significance of MRI in thrombotic multiple cerebral infarction was examined in 9 patients having recent lacunar stroke. Recent infarct was identified on Gd-enhanced MRI in 4 patients. For patients multiple small infarction, Gd-enhanced MRI made it possible to differentiate recent from other lesions. To clarify the significance of periventricular high intensity lesion (PVH) on T2-weighted MRI, hemodynamic and neuropsychologic examinations were carried out in 41 patients with multiple cerebral infarction. All the patients had PVH, which was classified into three grades as follows: grade I (n=16) showing only a thin high intensity band along the body of lateral ventricles; grade 2 (n=15) showing a definite high intensity area around the lateral ventricles; grade 3 (n=10) showing diffuse thick and irregular foci around the whole ventricle. In these patients, rCBF was measured by 133 Xe inhalation methods. Initial slope index was significantly higher in patients with grade 3 than those with grade I. Mini-mental state test score was significantly higher in patients with grade l than those with grade 2 and 3. Progression of PVH may be related with the reduction of the cerebral circulation and mental function in cases of multiple cerebral infarction. Ischemic and hemorrhagic lesions can be distinguished by MRI, because old intracerebral hemorrhage appear as hypointensity areas with or without hyperintensity area on T2w images. In 92 patients with multiple infarction, MRI was used to evaluate the incidence and distribution of coexisting old intracerebral hemorrhage. Old hemorrhage were found in 15 patients (16.3%). locating the site where hypertensive hemorrhage commonly occurred. High-field MRI is useful for assessing the coexistence of hemorrhage in hypertensive patients with multiple cerebral infarction. (N.K.)

The clinical phenotype of hereditary versus sporadic prostate cancer: HPC definition revisited

NARCIS (Netherlands)

Cremers, R.G.H.M.; Aben, K.K.H.; Oort, I.M. van; Sedelaar, J.P.M.; Vasen, H.F.A.; Vermeulen, S.H.; Kiemeney, L.A.L.M.

2016-01-01

BACKGROUND: The definition of hereditary prostate cancer (HPC) is based on family history and age at onset. Intuitively, HPC is a serious subtype of prostate cancer but there are only limited data on the clinical phenotype of HPC. Here, we aimed to compare the prognosis of HPC to the sporadic form

Donepezil improved memory in multiple sclerosis in a randomized clinical trial.

Science.gov (United States)

Krupp, L B; Christodoulou, C; Melville, P; Scherl, W F; MacAllister, W S; Elkins, L E

2004-11-09

To determine the effect of donepezil in treating memory and cognitive dysfunction in multiple sclerosis (MS). This single-center double-blind placebo-controlled clinical trial evaluated 69 MS patients with cognitive impairment who were randomly assigned to receive a 24-week treatment course of either donepezil (10 mg daily) or placebo. Patients underwent neuropsychological assessment at baseline and after 24 weeks of treatment. The primary outcome was change in verbal learning and memory on the Selective Reminding Test (SRT). Secondary outcomes included other tests of cognitive function, patient-reported change in memory, and clinician-reported impression of cognitive change. Donepezil-treated patients showed significant improvement in memory performance on the SRT compared to placebo (p = 0.043). The benefit of donepezil remained significant after controlling for various covariates including age, Expanded Disability Status Scale, baseline SRT score, reading ability, MS subtype, and sex. Donepezil-treated patients did not show significant improvements on other cognitive tests, but were more than twice as likely to report memory improvement than those in the placebo group (p = 0.006). The clinician also reported cognitive improvement in almost twice as many donepezil vs placebo patients (p = 0.036). No serious adverse events related to study medication occurred, although more donepezil (34.3%) than placebo (8.8%) subjects reported unusual/abnormal dreams (p = 0.010). Donepezil improved memory in MS patients with initial cognitive impairment in a single center clinical trial. A larger multicenter investigation of donepezil in MS is warranted in order to more definitively assess the efficacy of this intervention.

An 00 visual language definition approach supporting multiple views

OpenAIRE

Akehurst, David H.; I.E.E.E. Computer Society

2000-01-01

The formal approach to visual language definition is to use graph grammars and/or graph transformation techniques. These techniques focus on specifying the syntax and manipulation rules of the concrete representation. This paper presents a constraint and object-oriented approach to defining visual languages that uses UML and OCL as a definition language. Visual language definitions specify a mapping between concrete and abstract models of possible visual sentences, which carl subsequently be ...

Plasma Biomarkers Discriminate Clinical Forms of Multiple Sclerosis

Science.gov (United States)

Tejera-Alhambra, Marta; Casrouge, Armanda; de Andrés, Clara; Seyfferth, Ansgar; Ramos-Medina, Rocío; Alonso, Bárbara; Vega, Janet; Fernández-Paredes, Lidia; Albert, Matthew L.; Sánchez-Ramón, Silvia

2015-01-01

Multiple sclerosis, the most common cause of neurological disability in young population after trauma, represents a significant public health burden. Current challenges associated with management of multiple sclerosis (MS) patients stem from the lack of biomarkers that might enable stratification of the different clinical forms of MS and thus prompt treatment for those patients with progressive MS, for whom there is currently no therapy available. In the present work we analyzed a set of thirty different plasma cytokines, chemokines and growth factors present in circulation of 129 MS patients with different clinical forms (relapsing remitting, secondary progressive and primary progressive MS) and 53 healthy controls, across two independent cohorts. The set of plasma analytes was quantified with Luminex xMAP technology and their predictive power regarding clinical outcome was evaluated both individually using ROC curves and in combination using logistic regression analysis. Our results from two independent cohorts of MS patients demonstrate that the divergent clinical and histology-based MS forms are associated with distinct profiles of circulating plasma protein biomarkers, with distinct signatures being composed of chemokines and growth/angiogenic factors. With this work, we propose that an evaluation of a set of 4 circulating biomarkers (HGF, Eotaxin/CCL11, EGF and MIP-1β/CCL4) in MS patients might serve as an effective tool in the diagnosis and more personalized therapeutic targeting of MS patients. PMID:26039252

A modern definition of mediastinal compartments.

Science.gov (United States)

Carter, Brett W; Tomiyama, Noriyuki; Bhora, Faiz Y; Rosado de Christenson, Melissa L; Nakajima, Jun; Boiselle, Phillip M; Detterbeck, Frank C; Marom, Edith M

2014-09-01

Division of the mediastinum into compartments is used to help narrow the differential diagnosis of newly detected mediastinal masses, to assist in planning biopsy and surgical procedures, and to facilitate communication among clinicians of multiple disciplines. Several traditional mediastinal division schemes exist based upon arbitrary landmarks on the lateral chest radiograph. We describe a modern, computed tomography-based mediastinal division scheme, which has been accepted by the International Thymic Malignancy Interest Group as a new standard. This clinical classification defines a prevascular (anterior), a visceral (middle), and a paravertebral (posterior) compartment, with anatomic boundaries defined clearly by computed tomography. It is our intention that this definition be used in the reporting of clinical cases and the design of prospective clinical trials.

The ability of clinical balance measures to identify falls risk in multiple sclerosis: a systematic review and meta-analysis.

Science.gov (United States)

Quinn, Gillian; Comber, Laura; Galvin, Rose; Coote, Susan

2018-05-01

To determine the ability of clinical measures of balance to distinguish fallers from non-fallers and to determine their predictive validity in identifying those at risk of falls. AMED, CINAHL, Medline, Scopus, PubMed Central and Google Scholar. First search: July 2015. Final search: October 2017. Inclusion criteria were studies of adults with a definite multiple sclerosis diagnosis, a clinical balance assessment and method of falls recording. Data were extracted independently by two reviewers. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 scale and the modified Newcastle-Ottawa Quality Assessment Scale. Statistical analysis was conducted for the cross-sectional studies using Review Manager 5. The mean difference with 95% confidence interval in balance outcomes between fallers and non-fallers was used as the mode of analysis. We included 33 studies (19 cross-sectional, 5 randomised controlled trials, 9 prospective) with a total of 3901 participants, of which 1917 (49%) were classified as fallers. The balance measures most commonly reported were the Berg Balance Scale, Timed Up and Go and Falls Efficacy Scale International. Meta-analysis demonstrated fallers perform significantly worse than non-fallers on all measures analysed except the Timed Up and Go Cognitive ( p Balance Confidence Scale had the highest area under the receiver operating characteristic curve value (0.92), but without reporting corresponding measures of clinical utility. Clinical measures of balance differ significantly between fallers and non-fallers but have poor predictive ability for falls risk in people with multiple sclerosis.

Clinical Relevance of Brain Volume Measures in Multiple Sclerosis

DEFF Research Database (Denmark)

De Stefano, Nicola; Airas, Laura; Grigoriadis, Nikolaos

2014-01-01

Multiple sclerosis (MS) is a chronic disease with an inflammatory and neurodegenerative pathology. Axonal loss and neurodegeneration occurs early in the disease course and may lead to irreversible neurological impairment. Changes in brain volume, observed from the earliest stage of MS...... therefore have important clinical implications affecting treatment decisions, with several clinical trials now demonstrating an effect of disease-modifying treatments (DMTs) on reducing brain volume loss. In clinical practice, it may therefore be important to consider the potential impact of a therapy...

Terms, concepts and definitions in clinical artificial nutrition. The ConT-SEEN Project.

Science.gov (United States)

Del Olmo García, María Dolores; Ocón Bretón, Julia; Álvarez Hernández, Julia; Ballesteros Pomar, María Dolores; Botella Romero, Francisco; Bretón Lesmes, Irene; de Luis Román, Daniel; Luengo Pérez, Luis Miguel; Martínez Olmos, Miguel Ángel; Olveira Fuster, Gabriel

2018-01-01

Imprecision in terms used in the field of clinical nutrition may lead to misinterpretations among professionals. For this reason, the Spanish Society of Endocrinology and Nutrition (SEEN) promoted this document on the terms and definitions used in clinical artificial nutrition (enteral and parenteral), establishing an agreement between Spanish experts of this specialty. Forty-seven specialists in endocrinology and nutrition, members of the Nutrition Area of the SEEN, participated between April and September 2016. After a systematic literature review, 52 concepts were proposed. The coordinators included two additional concepts, and 57were finally selected by the working group: 13 of a general nature, 30 referring to enteral nutrition and 14 to parenteral nutrition. The degree of agreement was subsequently determined using a two-round Delphi process. It was finally ratified by consistency and concordance analysis. Fifty-four of the 57 terms had a very consistent agreement and were concordant. Only three showed no concordance, of whom two were very consistent and one inconsistent. In conclusion, there was consensus in the definition of 54 basic terms in the practice of clinical nutrition. Copyright © 2017 SEEN y SED. Publicado por Elsevier España, S.L.U. All rights reserved.

Searching for neurodegeneration in multiple sclerosis at clinical onset: Diagnostic value of biomarkers.

Science.gov (United States)

Novakova, Lenka; Axelsson, Markus; Malmeström, Clas; Imberg, Henrik; Elias, Olle; Zetterberg, Henrik; Nerman, Olle; Lycke, Jan

2018-01-01

Neurodegeneration occurs during the early stages of multiple sclerosis. It is an essential, devastating part of the pathophysiology. Tools for measuring the degree of neurodegeneration could improve diagnostics and patient characterization. This study aimed to determine the diagnostic value of biomarkers of degeneration in patients with recent clinical onset of suspected multiple sclerosis, and to evaluate these biomarkers for characterizing disease course. This cross-sectional study included 271 patients with clinical features of suspected multiple sclerosis onset and was the baseline of a prospective study. After diagnostic investigations, the patients were classified into the following disease groups: patients with clinically isolated syndrome (n = 4) or early relapsing remitting multiple sclerosis (early RRMS; n = 93); patients with relapsing remitting multiple sclerosis with disease durations ≥2 years (established RRMS; n = 39); patients without multiple sclerosis, but showing symptoms (symptomatic controls; n = 89); and patients diagnosed with other diseases (n = 46). In addition, we included healthy controls (n = 51) and patients with progressive multiple sclerosis (n = 23). We analyzed six biomarkers of neurodegeneration: cerebrospinal fluid neurofilament light chain levels; cerebral spinal fluid glial fibrillary acidic protein; cerebral spinal fluid tau; retinal nerve fiber layer thickness; macula volume; and the brain parenchymal fraction. Except for increased cerebral spinal fluid neurofilament light chain levels, median 670 ng/L (IQR 400-2110), we could not find signs of early degeneration in the early disease group with recent clinical onset. However, the intrathecal immunoglobin G production and cerebral spinal fluid neurofilament light chain levels showed diagnostic value. Moreover, elevated levels of cerebral spinal fluid glial fibrillary acidic protein, thin retinal nerve fiber layers, and low brain parenchymal fractions were associated with

The clinical impact of cerebellar grey matter pathology in multiple sclerosis.

Directory of Open Access Journals (Sweden)

Alfredo Damasceno

Full Text Available BACKGROUND: The cerebellum is an important site for cortical demyelination in multiple sclerosis, but the functional significance of this finding is not fully understood. OBJECTIVE: To evaluate the clinical and cognitive impact of cerebellar grey-matter pathology in multiple sclerosis patients. METHODS: Forty-two relapsing-remitting multiple sclerosis patients and 30 controls underwent clinical assessment including the Multiple Sclerosis Functional Composite, Expanded Disability Status Scale (EDSS and cerebellar functional system (FS score, and cognitive evaluation, including the Paced Auditory Serial Addition Test (PASAT and the Symbol-Digit Modalities Test (SDMT. Magnetic resonance imaging was performed with a 3T scanner and variables of interest were: brain white-matter and cortical lesion load, cerebellar intracortical and leukocortical lesion volumes, and brain cortical and cerebellar white-matter and grey-matter volumes. RESULTS: After multivariate analysis high burden of cerebellar intracortical lesions was the only predictor for the EDSS (p<0.001, cerebellar FS (p = 0.002, arm function (p = 0.049, and for leg function (p<0.001. Patients with high burden of cerebellar leukocortical lesions had lower PASAT scores (p = 0.013, while patients with greater volumes of cerebellar intracortical lesions had worse SDMT scores (p = 0.015. CONCLUSIONS: Cerebellar grey-matter pathology is widely present and contributes to clinical dysfunction in relapsing-remitting multiple sclerosis patients, independently of brain grey-matter damage.

American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials

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Felson, David T.; Smolen, Josef S.; Wells, George; Zhang, Bin; van Tuyl, Lilian H. D.; Funovits, Julia; Aletaha, Daniel; Allaart, Renée; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Dan; Gomez-Reino, Juan; Hawker , Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Mola, Emilio Martin; Montie, Pam; Pincus, Ted; Richards, Pam; Siegel, Jeff; Simon, Lee; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Fred; Zink, Angela; Boers, Maarten

2010-01-01

Background With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials. Methods A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes. Results Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the

Effect of Interval to Definitive Breast Surgery on Clinical Presentation and Survival in Early-Stage Invasive Breast Cancer

International Nuclear Information System (INIS)

Vujovic, Olga; Yu, Edward; Cherian, Anil; Perera, Francisco; Dar, A. Rashid; Stitt, Larry; Hammond, A.

2009-01-01

Purpose: To examine the effect of clinical presentation and interval to breast surgery on local recurrence and survival in early-stage breast cancer. Methods and Materials: The data from 397 patients with Stage T1-T2N0 breast carcinoma treated with conservative surgery and breast radiotherapy between 1985 and 1992 were reviewed at the London Regional Cancer Program. The clinical presentation consisted of a mammogram finding or a palpable lump. The intervals from clinical presentation to definitive breast surgery used for analysis were 0-4, >4-12, and >12 weeks. The Kaplan-Meier estimates of the time to local recurrence, disease-free survival, and cause-specific survival were determined for the three groups. Cox regression analysis was used to evaluate the effect of clinical presentation and interval to definitive surgery on survival. Results: The median follow-up was 11.2 years. No statistically significant difference was found in local recurrence as a function of the interval to definitive surgery (p = .424). A significant difference was noted in disease-free survival (p = .040) and cause-specific survival (p = .006) with an interval of >12 weeks to definitive breast surgery. However, the interval to definitive surgery was dependent on the presentation for cause-specific survival, with a substantial effect for patients with a mammographic presentation and a negligible effect for patients with a lump presentation (interaction p = .041). Conclusion: The results of this study suggest that an interval of >12 weeks to breast surgery might be associated with decreased survival for patients with a mammographic presentation, but it appeared to have no effect on survival for patients presenting with a palpable breast lump.

Clinical Application of {sup 18}F-FDG PET in Multiple Myeloma

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Lee, Su Jin; Choi, Joon Young [Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of)

2009-12-15

This review focuses on the clinical use of {sup 18}F-FDG PET to evaluate multiple myeloma. {sup 18}F-FDG PET is useful for diagnosis, staging of multiple myeloma and differential diagnosis of myeloma related disease such as monoclonal gammopathy of undetermined significance or plasmacytoma. For therapy response, {sup 18}F-FDG PET may be effective after chemotherapy for multiple myeloma and radiotherapy for plasmacytoma.

Fusion Simulation Program Definition. Final report

International Nuclear Information System (INIS)

Cary, John R.

2012-01-01

We have completed our contributions to the Fusion Simulation Program Definition Project. Our contributions were in the overall planning with concentration in the definition of the area of Software Integration and Support. We contributed to the planning of multiple meetings, and we contributed to multiple planning documents

Clinical and imaging assessment of cognitive dysfunction in multiple sclerosis

DEFF Research Database (Denmark)

Rocca, Maria A; Amato, Maria P; De Stefano, Nicola

2015-01-01

In patients with multiple sclerosis (MS), grey matter damage is widespread and might underlie many of the clinical symptoms, especially cognitive impairment. This relation between grey matter damage and cognitive impairment has been lent support by findings from clinical and MRI studies. However...... that causes clinical symptoms to trigger. Findings on cortical reorganisation support the contribution of brain plasticity and cognitive reserve in limiting cognitive deficits. The development of clinical and imaging biomarkers that can monitor disease development and treatment response is crucial to allow...

Clinical significance of reduced cerebral metabolism in multiple sclerosis. A combined PET and MRI study

International Nuclear Information System (INIS)

Sun, Xiayan; Tanaka, Makoto; Kondo, Susumu; Okamoto, Koichi; Hirai, Shunsaku

1998-01-01

Magnetic resonance imaging (MRI) in patients with multiple sclerosis (MS) has provided major insights into the disease's natural history, and many studies have focussed on possible correlations between MRI findings and the clinical manifestations of MS. In contrast, there are few reports on possible relationships between functional imaging data and cognitive function. The present study assessed the relationship between clinical presentation and combined anatomical and functional imaging data in MS. Twenty patients with definite MS underwent MRI and positron emission tomography (PET) to evaluate cerebral blood flow (rCBF) and oxygen metabolism (rCMRO 2 ). The relationships between these neuroimaging findings and clinical data, including the Expanded Disability Status Scale (EDSS), Mini-mental status scale, Hasegawa Dementia Scale and relapse time, were evaluated with Spearman's rank correlation coefficients. A general reduction in rCBF and rCMRO 2 in the gray and white matter were found in the MS patients. EDSS was correlated with the number and size of the lesions on MRI and was negatively correlated with rCMRO 2 . A correlation between the decrease in rCMRO 2 and the level of cognitive impairment was also found. The severity of cerebral hypometabolism was also related to the number of relapses. Morphological and functional findings obtained by MRI and PET are closely related to the clinical status in MS. Our results suggest that measurement of cerebral metabolism in MS has the potential to be an objective marker for monitoring disease activity and to provide prognostic information. (author)

Variation of gross tumor volume and clinical target volume definition for lung cancer

International Nuclear Information System (INIS)

Liang Jun; Li Minghui; Chen Dongdu

2011-01-01

Objective: To study the variation of gross tumor volume (GTV) and clinical target volume (CTV) definition for lung cancer between different doctors. Methods: Ten lung cancer patients with PET-CT simulation were selected from January 2008 to December 2009.GTV and CTV of these patients were defined by four professors or associate professors of radiotherapy independently. Results: The mean ratios of largest to smallest GTV and CTV were 1.66 and 1.65, respectively. The mean coefficients of variation for GTV and CTV were 0.20 and 0.17, respectively. System errors of CTV definition in three dimension were less than 5 mm, which was the largest in inferior and superior (0.48 cm, 0.37 cm, 0.32 cm; F=0.40, 0.60, 0.15, P=0.755, 0.618, 0.928). Conclusions: The variation of GTV and CTV definition for lung cancer between different doctors exist. The mean ratios of largest to smallest GTV and CTV were less than 1.7. The variation was in hilar and mediastinum lymphanode regions. System error of CTV definition was the largest (<5 mm) in cranio-caudal direction. (authors)

What is a clinical pathway? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review

NARCIS (Netherlands)

A.K. Lawal (Adegboyega K.); T. Rotter (Thomas); L. Kinsman (Leigh); A. Machotta (Andreas); U. Ronellenfitsch (Ulrich); S.D. Scott (Shannon D.); D. Goodridge (Donna); C. Plishka (Christopher); G. Groot (Gary)

2016-01-01

textabstractClinical pathways (CPWs) are a common component in the quest to improve the quality of health. CPWs are used to reduce variation, improve quality of care, and maximize the outcomes for specific groups of patients. An ongoing challenge is the operationalization of a definition of CPW in

Relationship between autonomic cardiovascular control, case definition, clinical symptoms, and functional disability in adolescent chronic fatigue syndrome: an exploratory study.

Science.gov (United States)

Wyller, Vegard B; Helland, Ingrid B

2013-02-07

Chronic Fatigue Syndrome (CFS) is characterized by severe impairment and multiple symptoms. Autonomic dysregulation has been demonstrated in several studies. We aimed at exploring the relationship between indices of autonomic cardiovascular control, the case definition from Centers for Disease Control and Prevention (CDC criteria), important clinical symptoms, and disability in adolescent chronic fatigue syndrome. 38 CFS patients aged 12-18 years were recruited according to a wide case definition (ie. not requiring accompanying symptoms) and subjected to head-up tilt test (HUT) and a questionnaire. The relationships between variables were explored with multiple linear regression analyses. In the final models, disability was positively associated with symptoms of cognitive impairments (p<0.001), hypersensitivity (p<0.001), fatigue (p=0.003) and age (p=0.007). Symptoms of cognitive impairments were associated with age (p=0.002), heart rate (HR) at baseline (p=0.01), and HR response during HUT (p=0.02). Hypersensitivity was associated with HR response during HUT (p=0.001), high-frequency variability of heart rate (HF-RRI) at baseline (p=0.05), and adherence to the CDC criteria (p=0.005). Fatigue was associated with gender (p=0.007) and adherence to the CDC criteria (p=0.04). In conclusion, a) The disability of CFS patients is not only related to fatigue but to other symptoms as well; b) Altered cardiovascular autonomic control is associated with certain symptoms; c) The CDC criteria are poorly associated with disability, symptoms, and indices of altered autonomic nervous activity.

Multiple Sclerosis Relapses: Epidemiology, Outcomes and Management. A Systematic Review.

Science.gov (United States)

Kalincik, Tomas

2015-01-01

Relapses (episodic exacerbations of neurological signs or symptoms) are a defining feature of relapsing-remitting multiple sclerosis (MS), the most prevalent MS phenotype. While their diagnostic value relates predominantly to the definition of clinically definite MS, their prognostic value is determined by their relatively high associated risk of incomplete remission resulting in residual disability. The mechanisms governing a relapse incidence are unknown, but numerous modifiers of relapse risk have been described, including demographic and clinical characteristics, many of which represent opportunities for improved disease management. Also relapse phenotypes have been associated with patient and disease characteristics and an individual predisposition to certain phenotypic presentations may imply individual neuroanatomical disease patterns. While immunomodulatory therapies and corticosteroids represent the mainstay of relapse prevention and acute management, respectively, their effect has only been partial and further search for more efficient relapse therapies is warranted. Other areas of research include pathophysiology and determinants of relapse incidence, recurrence and phenotypes, including the characteristics of the relapsing and non-relapsing multiple sclerosis variants and their responsiveness to therapies. © 2015 S. Karger AG, Basel.

Magnetic resonance imaging compared with trimodal evoked potentials in possible multiple sclerosis

International Nuclear Information System (INIS)

Roullet, E.; Leger-Ravet, M.B.; Amarenco, P.; Marteau, R.; Lavallard-Rousseau, M.-C.; Dupuch, K.; Iba-Zizen, M.T.; Tamraz, J.; Cabanis, E.A.

1988-01-01

Magnetic Resonance Imaging (MRI) of the brain and Evoked Potentials (EP) can both demonstrate the presence of clinically unsuspected demyelinating lesions and have proven to be sensitive (but not specific) in the diagnosis of multiple sclerosis (MS). MRI and EP are positive in 90 to 100% of patients with a definite diagnosis of MS. However, few studies have been conducted in patients with a lesser diagnostic certainty. In possible or suspected MS they gave conflicting results, possibly because of technical discrepancies and different clinical inclusion criteria. Since a number of putative new treatments can be evaluated in patients who have a definite diagnosis of MS, but nevertheless a short duration of disease and a low disability, it was decided to compare the sensitivity of MRI and EP as diagnostic tools in possible MS patients. MRI is shown to be more sensitive, shows more multiple lesions and gives a clearer appreciation of their size and exact location than EP. 10 refs.; 3 tabs

Access block in NSW hospitals, 1999-2001: does the definition matter?

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Forero, Roberto; Mohsin, Mohammed; Bauman, Adrian E; Ieraci, Sue; Young, Lis; Phung, Hai N; Hillman, Kenneth M; McCarthy, Sally M; Hugelmeyer, C David

2004-01-19

To estimate the magnitude of access block and its trend over time in New South Wales hospitals, using different definitions of access block, and to explore its association with clinical and non-clinical factors. An epidemiological study using the Emergency Department Information System datasets (1 January 1999 to 31 December 2001) from a sample of 55 NSW hospitals. Prevalence of access block measured by four different definitions; strength of association between access block, type of hospital, year of presentation, mode and time of arrival, triage category (an indicator of urgency), age and sex. Rates of access block (for all four definitions) increased between 1999 and 2001 by 1%-2% per year. There were increases across all regions of NSW, but urban regions in particular. Patients presenting to Principal Referral hospitals and those who arrived at night were more likely to experience access block. After adjusting for triage category and year of presentation, the mode of arrival, time of arrival, type of hospital, age and sex were significantly associated with access block. Access block continues to increase across NSW, whatever the definition used. We recommend that hospitals in NSW and Australia move to the use of one standard definition of access block, as our study suggests there is no significant additional information emerging from the use of multiple definitions.

Clinical Research Informatics: Challenges, Opportunities and Definition for an Emerging Domain

Science.gov (United States)

Embi, Peter J.; Payne, Philip R.O.

2009-01-01

Objectives Clinical Research Informatics, an emerging sub-domain of Biomedical Informatics, is currently not well defined. A formal description of CRI including major challenges and opportunities is needed to direct progress in the field. Design Given the early stage of CRI knowledge and activity, we engaged in a series of qualitative studies with key stakeholders and opinion leaders to determine the range of challenges and opportunities facing CRI. These phases employed complimentary methods to triangulate upon our findings. Measurements Study phases included: 1) a group interview with key stakeholders, 2) an email follow-up survey with a larger group of self-identified CRI professionals, and 3) validation of our results via electronic peer-debriefing and member-checking with a group of CRI-related opinion leaders. Data were collected, transcribed, and organized for formal, independent content analyses by experienced qualitative investigators, followed by an iterative process to identify emergent categorizations and thematic descriptions of the data. Results We identified a range of challenges and opportunities facing the CRI domain. These included 13 distinct themes spanning academic, practical, and organizational aspects of CRI. These findings also informed the development of a formal definition of CRI and supported further representations that illustrate areas of emphasis critical to advancing the domain. Conclusions CRI has emerged as a distinct discipline that faces multiple challenges and opportunities. The findings presented summarize those challenges and opportunities and provide a framework that should help inform next steps to advance this important new discipline. PMID:19261934

Case definition for clinical and subclinical bacterial kidney disease (BKD) in Atlantic Salmon (Salmo salar L.) in New Brunswick, Canada.

Science.gov (United States)

Boerlage, A S; Stryhn, H; Sanchez, J; Hammell, K L

2017-03-01

Bacterial kidney disease (BKD) is considered an important cause of loss in salmon aquaculture in Atlantic Canada. Causative agent of BKD is the Gram-positive bacteria Renibacterium salmoninarum. Infected salmon are often asymptomatic (subclinical infection), and the disease is considered chronic. One of the challenges in quantifying information from farm production and health records is the application of a standardized case definition. Case definitions for farm-level and cage-level clinical and subclinical BKD were developed using retrospective longitudinal data from aquaculture practices in New Brunswick, Canada, combining (i) industry records of weekly production data including mortalities, (ii) field observations for BKD using reports of veterinarians and/or fish health technicians, (iii) diagnostic submissions and test results and (iv) treatments used to control BKD. Case definitions were evaluated using veterinarians' expert judgements as reference standard. Eighty-nine and 66% of sites and fish groups, respectively, were associated with BKD at least once. For BKD present (subclinical or clinical), sensitivity and specificity of the case definition were 75-100% varying between event, fish group, site cycle and level (site pen). For clinical BKD, sensitivities were 29-64% and specificities 91-100%. Industry data can be used to develop sensitive case definitions. © 2016 John Wiley & Sons Ltd.

Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes

Science.gov (United States)

Hamasaki, Toshimitsu; Asakura, Koko; Evans, Scott R; Sugimoto, Tomoyuki; Sozu, Takashi

2015-01-01

We discuss the decision-making frameworks for clinical trials with multiple co-primary endpoints in a group-sequential setting. The decision-making frameworks can account for flexibilities such as a varying number of analyses, equally or unequally spaced increments of information and fixed or adaptive Type I error allocation among endpoints. The frameworks can provide efficiency, i.e., potentially fewer trial participants, than the fixed sample size designs. We investigate the operating characteristics of the decision-making frameworks and provide guidance on constructing efficient group-sequential strategies in clinical trials with multiple co-primary endpoints. PMID:25844122

Clinical, psychological and demographic parameters of body pain in multiple sclerosis

Directory of Open Access Journals (Sweden)

Ghasem Salehpoor

2017-02-01

Full Text Available Background: Body pain in multiple sclerosis (MS is a common phenomenon that can create or exacerbate by different parameters of clinical, psychological and demographic. The aim of this study was to investigate the relationship between parameters of clinical (fatigue, clinical course, body mass index and duration, psychological (depression, anxiety and stress and demographic (age, gender, marital status and education characters with multiple sclerosis patient’s body pain. Methods: This cross-sectional study has been performed in the Multiple Sclerosis Society of Guilan Province and Imam Reza Specialized and Sub-specialized Clinic, Rasht City, Iran during June to February 2010. In this study 162 patients with MS were selected by consecutive sampling. We used the clinical and demographic variables inventory, body pain subscale of the health survey questionnaire, depression, anxiety and stress scale and fatigue severity scale along with identical analog-spring balance. The data were analyzed by Pearson correlation coefficient and point bi-serial, one-way analysis of variance, Gabriel test and stepwise multiple regression. Results: The findings showed that patients who scored 3 or higher in relapses experienced significantly more body pain than patients who scored 1-2 times of relapses (P= 0.031. In the meantime, significant differences were not found between the two groups of patients with a score of 3 or higher in relapses and non-relapse and between non-relapse patients and with a score 1-2 times of relapses in terms of body pain. Also, significant differences were not found in different groups of hospitalization in terms of body pain. However, anxiety and fatigue together could explain significantly 25% of the shared variance of body pain (F= 26.29, P≤ 0.0009. Conclusion: This study showed the effect of psychological and clinical factors on body pain exacerbation in MS patients. Therefore, it is necessary for clinicians to consider

Confirmed clinical case of chronic kidney disease of nontraditional causes in agricultural communities in Central America: a case definition for surveillance

Directory of Open Access Journals (Sweden)

Alejandro Ferreiro

Full Text Available ABSTRACT Over the last 20 years, many reports have described an excess of cases of chronic kidney disease (CKD in the Pacific coastal area of Central America, mainly affecting male farmworkers and signaling a serious public health problem. Most of these cases are not associated with traditional risk factors for CKD, such as aging, diabetes mellitus, and hypertension. This CKD of nontraditional causes (CKDnT might be linked to environmental and/or occupational exposure or working conditions, limited access to health services, and poverty. In response to a resolution approved by the Directing Council of the Pan American Health Organization (PAHO in 2013, PAHO, the U.S. Centers for Disease Control and Prevention, and the Latin American Society of Nephrology and Hypertension (SLANH organized a consultation process in order to expand knowledge on the epidemic of CKDnT and to develop appropriate surveillance instruments. The Clinical Working Group from SLANH was put in charge of finding a consensus definition of a confirmed clinical case of CKDnT. The resulting definition establishes mandatory criteria and exclusion criteria necessary for classifying a case of CKDnT. The definition includes a combination of universally accepted definitions of CKD and the main clinical manifestations of CKDnT. Based on the best available evidence, the Clinical Working Group also formulated general recommendations about clinical management that apply to any patient with CKDnT. Adhering to the definition of a confirmed clinical case of CKDnT and implementing it appropriately is expected to be a powerful instrument for understanding the prevalence of the epidemic, evaluating the results of interventions, and promoting appropriate advocacy and planning efforts.

Confirmed clinical case of chronic kidney disease of nontraditional causes in agricultural communities in Central America: a case definition for surveillance.

Science.gov (United States)

Ferreiro, Alejandro; Álvarez-Estévez, Guillermo; Cerdas-Calderón, Manuel; Cruz-Trujillo, Zulma; Mena, Elio; Reyes, Marina; Sandoval-Diaz, Mabel; Sánchez-Polo, Vicente; Valdés, Régulo; Ordúnez, Pedro

2016-11-01

Over the last 20 years, many reports have described an excess of cases of chronic kidney disease (CKD) in the Pacific coastal area of Central America, mainly affecting male farmworkers and signaling a serious public health problem. Most of these cases are not associated with traditional risk factors for CKD, such as aging, diabetes mellitus, and hypertension. This CKD of nontraditional causes (CKDnT) might be linked to environmental and/or occupational exposure or working conditions, limited access to health services, and poverty. In response to a resolution approved by the Directing Council of the Pan American Health Organization (PAHO) in 2013, PAHO, the U.S. Centers for Disease Control and Prevention, and the Latin American Society of Nephrology and Hypertension (SLANH) organized a consultation process in order to expand knowledge on the epidemic of CKDnT and to develop appropriate surveillance instruments. The Clinical Working Group from SLANH was put in charge of finding a consensus definition of a confirmed clinical case of CKDnT. The resulting definition establishes mandatory criteria and exclusion criteria necessary for classifying a case of CKDnT. The definition includes a combination of universally accepted definitions of CKD and the main clinical manifestations of CKDnT. Based on the best available evidence, the Clinical Working Group also formulated general recommendations about clinical management that apply to any patient with CKDnT. Adhering to the definition of a confirmed clinical case of CKDnT and implementing it appropriately is expected to be a powerful instrument for understanding the prevalence of the epidemic, evaluating the results of interventions, and promoting appropriate advocacy and planning efforts.

HLA typing in acute optic neuritis. Relation to multiple sclerosis and magnetic resonance imaging findings

DEFF Research Database (Denmark)

Frederiksen, J.L.; Madsen, H.O.; Ryder, L.P.

1997-01-01

OBJECTIVE: To study the association of brain magnetic resonance imaging (MRI) findings and HLA findings to clarify the relationship between monosymptomatic optic neuritis (ON) and ON as part of clinically definite multiple sclerosis (CDMS). DESIGN: Population-based cohort of patients with ON refe......OBJECTIVE: To study the association of brain magnetic resonance imaging (MRI) findings and HLA findings to clarify the relationship between monosymptomatic optic neuritis (ON) and ON as part of clinically definite multiple sclerosis (CDMS). DESIGN: Population-based cohort of patients......: The frequency of HLA-DR15 was significantly increased in patients with ON + CDMS (52%) and ON (47%) compared with control subjects (31%). The frequency of HLA-DR17 was almost equal in the ON + CDMS (18%), ON (23%), and control (23%) groups. The frequencies of HLA-DQA-1B (55% in ON + CDMS, 58% in ON) and HLA...

Clinical evaluation of multiple exostoses (17 cases) on bonescintigraphy

Energy Technology Data Exchange (ETDEWEB)

Yamada, Takayuki; Nakamura, Mamoru; Sugita, Reiji; Satou, Akihiro; Sakamoto, Kiyohiko (Tohoku Univ., Sendai (Japan). School of Medicine)

1991-03-01

Seventeen patients with multiple exostoses were examined on bone scintigraphy. Inheritance was recognized on seven patients (41%). Onset age of 15 patients was under 20 years old and 10 patients were under 10. The number of lesions was 211 and they were usually recognized at metaphyses of long bones. The degree of accumulation was classified into four grades: 0 (non increased), 1 (slightly-mild), 2 (moderate), and 3 (strong). One hundred and fifty-three lesions (73%) did not show definite increased activity (Grade 0, 1). Grade 3 included 14 lesions and they tended to be strongly calcified on X-P. This disease was said to transform into chondrosarcoma in 10 to 20%. Transformation was said to occur preferably in adults at heavily calcified lesion or one which showed irregularly thick hyaline cartilage. Such lesions showed more increased accumulation than normal bones. In our cases three cases were resected for this reason but turned out to be benign histologically. One case showed malignant transformation. In this case, a large malignant tumor replaced the parent bone and bone scan showed the cold lesion. Bone scintigraphy was considered useful to evaluate the biological activity of multiple exostoses. (author).

Clinical target volume delineation including elective nodal irradiation in preoperative and definitive radiotherapy of pancreatic cancer

Directory of Open Access Journals (Sweden)

Caravatta Luciana

2012-06-01

Full Text Available Abstract Background Radiotherapy (RT is widely used in the treatment of pancreatic cancer. Currently, recommendation has been given for the delineation of the clinical target volume (CTV in adjuvant RT. Based on recently reviewed pathologic data, the aim of this study is to propose criteria for the CTV definition and delineation including elective nodal irradiation (ENI in the preoperative and definitive treatment of pancreatic cancer. Methods The anatomical structures of interest, as well as the abdominal vasculature were identified on intravenous contrast-enhanced CT scans of two different patients with pancreatic cancer of the head and the body. To delineate the lymph node area, a margin of 10 mm was added to the arteries. Results We proposed a set of guidelines for elective treatment of high-risk nodal areas and CTV delineation. Reference CT images were provided. Conclusions The proposed guidelines could be used for preoperative or definitive RT for carcinoma of the head and body of the pancreas. Further clinical investigations are needed to validate the defined CTVs.

Clinical case definition and manifestations of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome.

Science.gov (United States)

Manosuthi, Weerawat; Van Tieu, Hong; Mankatitham, Wiroj; Lueangniyomkul, Aroon; Ananworanich, Jintanat; Avihingsanon, Anchalee; Siangphoe, Umaporn; Klongugkara, Sukonsri; Likanonsakul, Sirirat; Thawornwan, Unchana; Suntisuklappon, Bussakorn; Sungkanuparph, Somnuek

2009-11-27

The International Network for the Study of HIV-associated IRIS (INSHI) recently published criteria for tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) diagnosis. The performance of this definition and clinical manifestations of TB-IRIS were studied. Antiretroviral therapy-naive HIV/TB Thai patients receiving antituberculous therapy were enrolled during 2006-2007 and prospectively followed through 24 weeks of antiretroviral therapy. Patients were defined as having paradoxical TB-IRIS if they fulfilled the 'study definition' by French 2004 and were confirmed by an external reviewer. All were later compared by the classification according to 'INSHI-2008'. For the 126 patients, median baseline CD4 cell count was 43 cells/microl and HIV-1 RNA was 5.9 log(10) Y copies/ml. Seventy-three (58%) had extrapulmonary/disseminated TB. Twenty-two (18%) and 21 (17%) fulfilled TB-IRIS criteria according to the study definition and INSHI-2008 definition, respectively. Two (2%) were diagnosed by study definition only and one (1%) by INSHI-2008 definition only. Twenty (16%) were concordantly diagnosed by both definitions and 103 (82%) were consistently negative. Eighteen (82%) had worsening of a preexisting site, whereas four (18%) had TB-IRIS in a new location. Lymph node enlargement (73%) and fever (59%) were common in TB-IRIS. Sensitivity and specificity of INSHI-2008 was 91% (95% confidence interval, 72-98%) and 99% (95% confidence interval, 95-99.8%), respectively. Positive predictive value was 95% and negative predictive value was 98%. By multivariate analysis, factors predicting TB-IRIS were extrapulmonary TB (odds ratio, 8.63) and disseminated TB (odds ratio, 4.17). There was high concordance between the INSHI-2008 and French 2004 definition for TB-IRIS diagnosis in HIV/TB patients with relatively high rate of paradoxical TB-IRIS. This suggests that lack of HIV-1 RNA and CD4 cell count monitoring does not impede the ability to diagnose TB-IRIS.

Magnetic resonance imaging in multiple sclerosis

International Nuclear Information System (INIS)

Kesselring, J.; Ormerod, I.E.C.; Miller, D.H.; Du Boulay, G.H.; McDonald, W.I.

1989-01-01

In 1983 the Multiple Sclerosis Society of Great Britain and Northern Ireland set up the Multiple Sclerosis NMR Research Group at the Institute of Neurology and the National Hospital, Queen Square. The first aim of the Group was to define the role of MRI in the diagnosis and differential diagnosis of multiple sclerosis, and this Atlas represents a summary of that work. Our strategy was to determine the pattern of MRI abnormalities in clinically definite MS and to compare it with those of isolated clinical syndromes of the kind seen in MS (e.g. optic neuritis) and of other disorders with which MS can be confused clinically or radiologically. We have also been involved in a major program of experimental work designed to elucidate the origin of the abnormal signals in MRI. To describe this in full detail would go beyond the scope of the Atlas, but we have incorporated such results as far as they illuminate our clinical problems. The imager used was a 0.5 Tesla Picker superconducting system. Technical advances have been rapid since we began. Nevertheless, the quality of the images obtained at our relatively low field has enabled us to establish the patterns of abnormality in the brain in MS and the diseases which must be distinguished from it. (orig./MG)

Differential diagnosis of Mendelian and mitochondrial disorders in patients with suspected multiple sclerosis

Science.gov (United States)

Katz Sand, Ilana B.; Honce, Justin M.; Lublin, Fred D.

2015-01-01

Several single gene disorders share clinical and radiologic characteristics with multiple sclerosis and have the potential to be overlooked in the differential diagnostic evaluation of both adult and paediatric patients with multiple sclerosis. This group includes lysosomal storage disorders, various mitochondrial diseases, other neurometabolic disorders, and several other miscellaneous disorders. Recognition of a single-gene disorder as causal for a patient’s ‘multiple sclerosis-like’ phenotype is critically important for accurate direction of patient management, and evokes broader genetic counselling implications for affected families. Here we review single gene disorders that have the potential to mimic multiple sclerosis, provide an overview of clinical and investigational characteristics of each disorder, and present guidelines for when clinicians should suspect an underlying heritable disorder that requires diagnostic confirmation in a patient with a definite or probable diagnosis of multiple sclerosis. PMID:25636970

Prediction of a multiple sclerosis diagnosis in patients with clinically isolated syndrome using the 2016 MAGNIMS and 2010 McDonald criteria

DEFF Research Database (Denmark)

Filippi, Massimo; Preziosa, Paolo; Meani, Alessandro

2018-01-01

of the distinction between symptomatic and asymptomatic lesions was suggested. We compared the performance of the 2010 McDonald and 2016 MAGNIMS criteria for multiple sclerosis diagnosis in a large multicentre cohort of patients with CIS to provide evidence to guide revisions of multiple sclerosis diagnostic......, 2017, 571 patients with CIS were screened, of whom 368 met all study inclusion criteria. At the last evaluation (median 50·0 months [IQR 27·0-78·4]), 189 (51%) of 368 patients developed clinically definite multiple sclerosis. At 36 months, the two DIS criteria showed high sensitivity (2010 McDonald 0......·32-0·50], and similar AUC (0·63 [0·57-0·68]). Inclusion of optic nerve evaluation resulted in similar sensitivity (0·92 [0·87-0·96]), and slightly lower specificity (0·26 [0·18-0·34]) and AUC (0·59 [0·55-0·64]). AUC values were also similar for DIT (2010 McDonald 0·61 [0·55-0·67] and 2016 MAGNIMS 0·61 [0...

The essential role of t cells in multiple sclerosis: A reappraisal

Directory of Open Access Journals (Sweden)

Cris S Constantinescu

2014-04-01

Full Text Available Multiple sclerosis is an inflammatory demyelinating disease of the central nervous system in which destruction of myelin and nerve axons has been shown to be mediated by immune mechanisms. Although the focus of research has been traditionally on T cells as key mediators of the immunopathology, more recent efforts at understanding this complex disorder have been directed increasingly at other cellular and humoral elements of the immune response. This review is a reappraisal of the crucial role of T cells, in particular the CD4+ helper T-cell subset, in multiple sclerosis. Recent evidence is discussed underlining the predominant contribution of T-cell-associated genes to the genome-wide association study results of multiple sclerosis susceptibility, the loss of T-cell quiescence in the conversion from clinically isolated syndrome to clinically definite multiple sclerosis, and the fact that T cells represent the main target of effective immunomodulatory and immunosuppressive treatments in multiple sclerosis.

Clinically isolated syndrome. Prognostic markers for conversion to multiple sclerosis and initiation of disease-modifying therapy

International Nuclear Information System (INIS)

Kohriyama, Tatsuo

2011-01-01

Eighty-five percent of patients with multiple sclerosis (MS) initially present with a single demyelinating event, referred to as a clinically isolated syndrome (CIS) of the optic nerves, brainstem, or spinal cord. Following the onset of CIS, 38 to 68% of patients develop clinically definite MS (CDMS). Clinically silent brain lesions are seen on MRI in 50 to 80% of patients with CIS at first clinical presentation and 56 to 88% of CIS patients with abnormal MRI are at high risk of conversion to CDMS. Axonal damage, that is considered to underlie the development of persistent disability in MS, occurs in the CIS stage. Treatment with disease-modifying therapies (DMTs), that might prevent axonal damage and result in slowing the progression of disability, should be initiated early during the disease course. Clinical trials demonstrated that early treatment of CIS patients with the standard dose of interferon beta (IFNβ) significantly reduced the risk of progression to CDMS by 44 to 50%. After 5 years of follow-up, the results of the IFNβ treatment extension studies confirmed that the risk of conversion to CDMS was significantly reduced by 35 to 37% in patients receiving early treatment compared to that in those receiving delayed treatment. However, not every patient with CIS will progress to CDMS; the IFNβ treatment is appropriately indicated for CIS patients who are diagnosed with MS by McDonald diagnostic criteria based on MRI findings of dissemination in space and time and are at high risk for conversion to CDMS. Development of more reliable prognostic markers will enable DMTs to be targeted for those who are most likely to benefit. (author)

Can the Cancer-related Fatigue Case-definition Criteria Be Applied to Chronic Medical Illness? A Comparison between Breast Cancer and Systemic Sclerosis.

Science.gov (United States)

Kwakkenbos, Linda; Minton, Ollie; Stone, Patrick C; Alexander, Susanna; Baron, Murray; Hudson, Marie; Thombs, Brett D

2015-07-01

Fatigue is a crucial determinant of quality of life across rheumatic diseases, but the lack of agreed-upon standards for identifying clinically significant fatigue hinders research and clinical management. Case definition criteria for cancer-related fatigue were proposed for inclusion in the International Classification of Diseases. The objective was to evaluate whether the cancer-related fatigue case definition performed equivalently in women with breast cancer and systemic sclerosis (SSc) and could be used to identify patients with chronic illness-related fatigue. The cancer-related fatigue interview (case definition criteria met if ≥ 5 of 9 fatigue-related symptoms present with functional impairment) was completed by 291 women with SSc and 278 women successfully treated for breast cancer. Differential item functioning was assessed with the multiple indicator multiple cause model. Items 3 (concentration) and 10 (short-term memory) were endorsed significantly less often by women with SSc compared with cancer, controlling for responses on other items. Omitting these 2 items from the case definition and requiring 4 out of the 7 remaining symptoms resulted in a similar overall prevalence of cancer-related fatigue in the cancer sample compared with the original criteria (37.4% vs 37.8%, respectively), with 97.5% of patients diagnosed identically with both definitions. Prevalence of chronic illness-related fatigue was 36.1% in SSc using 4 of 7 symptoms. The cancer-related fatigue criteria can be used equivalently to identify patients with chronic illness-related fatigue when 2 cognitive fatigue symptoms are omitted. Harmonized definitions and measurement of clinically significant fatigue will advance research and clinical management of fatigue in rheumatic diseases and other conditions.

Chronic parotitis with multiple calcifications: Clinical and sialendoscopic findings.

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Jáuregui, Emmanuel; Kiringoda, Ruwan; Ryan, William R; Eisele, David W; Chang, Jolie L

2017-07-01

To characterize clinical, imaging, and sialendoscopy findings in patients with chronic parotitis and multiple parotid calcifications. Retrospective review. Clinical history, radiographic images and reports, lab tests, and operative reports were reviewed for adult patients with chronic parotitis and multiple parotid calcifications who underwent parotid sialendoscopy. Thirteen of 133 (10%) patients undergoing parotid sialendoscopy for chronic sialadenitis had more than one calcification in the region of the parotid gland. Seven patients (54%) were diagnosed with immune-mediated disease from autoimmune parotitis (positive Sjögren's antibodies or antinuclear antibodies) or human immunodeficiency virus (HIV) disease. The six patients (46%) who did not have an immune-mediated disorder had most calcifications located anterior or along the masseter muscle. Eight of 13 patients (61%) had at least one calculus found in the parotid duct on sialendoscopy. Four patients (38%) had multiple punctate calcifications within the parotid gland, all of whom had either autoimmune parotitis or HIV. None of the proximal or punctate parotid calcifications posterior to the masseter were visualized on sialendoscopy. Chronic parotitis in conjunction with multiple parotid calcifications is uncommon and was identified in 10% of our cohort. We contrast two classifications of parotid calcifications: 1) intraductal stones that cause recurrent duct obstruction and are often located within the main parotid duct along or anterior to the masseter and 2) punctate intraparenchymal parotid gland calcifications that are not visualized on sialendoscopy and may represent underlying inflammatory disease. 4 Laryngoscope, 127:1565-1570, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Proposed Rectal Dose Constraints for Patients Undergoing Definitive Whole Pelvic Radiotherapy for Clinically Localized Prostate Cancer

International Nuclear Information System (INIS)

Chan, Linda W.; Xia Ping; Gottschalk, Alexander R.; Akazawa, Michelle; Scala, Matthew; Pickett, Barby M.S.; Hsu, I-C.; Speight, Joycelyn; Roach, Mack

2008-01-01

Purpose: Although several institutions have reported rectal dose constraints according to threshold toxicity, the plethora of trials has resulted in multiple, confusing dose-volume histogram recommendations. A set of standardized, literature-based constraints for patients undergoing whole pelvic radiotherapy (RT) for prostate cancer would help guide the practice of prostate RT. The purpose of this study was to develop these constraints, demonstrate that they are achievable, and assess the corresponding rectal toxicity. Methods and Materials: An extensive literature search identified eight key studies relating dose-volume histogram data to rectal toxicity. A correction factor was developed to address differences in the anatomic definition of the rectum across studies. The dose-volume histogram constraints recommended by each study were combined to generate the constraints. The data from all patients treated with definitive intensity-modulated RT were then compared against these constraints. Acute rectal toxicity was assessed. Results: A continuous, proposed rectal dose-constraint curve was generated. Intensity-modulated RT not only met this constraint curve, but also was able to achieve at least 30-40% lower dose to the rectum. The preliminary clinical results were also positive: 50% of patients reported no acute bowel toxicity, 33% reported Grade 1 toxicity, and 17% reported Grade 2 toxicity. No patients reported Grade 3-4 acute rectal toxicity. Conclusions: In this study, we developed a set of proposed rectal dose constraints. This allowed for volumetric assessment of the dose-volume relationship compared with single dose-volume histogram points. Additional research will be performed to validate this threshold as a class solution for rectal dose constraints

Cervicitis aetiology and case definition: a study in Australian women attending sexually transmitted infection clinics.

Science.gov (United States)

Lusk, M Josephine; Garden, Frances L; Rawlinson, William D; Naing, Zin W; Cumming, Robert G; Konecny, Pam

2016-05-01

Studies examining cervicitis aetiology and prevalence lack comparability due to varying criteria for cervicitis. We aimed to outline cervicitis associations and suggest a best case definition. A cross-sectional study of 558 women at three sexually transmitted infection clinics in Sydney, Australia, 2006-2010, examined pathogen and behavioural associations of cervicitis using three cervicitis definitions: 'microscopy' (>30 pmnl/hpf (polymorphonuclear leucocytes per high-powered field on cervical Gram stain)), 'cervical discharge' (yellow and/or mucopurulent cervical discharge) or 'micro+cervical discharge' (combined 'microscopy' and 'cervical discharge'). Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Trichomonas vaginalis (TV) and Neisseria gonorrhoeae (NG) had the strongest associations with cervicitis definitions 'micro+cervical discharge': CT adjusted prevalence ratio (APR)=2.13 (95% CI 1.38 to 3.30) p=0.0006, MG APR=2.21 (1.33 to 3.69) p=0.002, TV APR=2.37 (1.44 to 3.90) p=0.0007 NG PR=4.42 (3.79 to 5.15) pdefinitions with best clinical utility and pathogen prediction were 'cervical discharge' and 'micro+cervical discharge'. 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/

Prognostic value of high-field proton magnetic resonance spectroscopy in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis

Energy Technology Data Exchange (ETDEWEB)

Wattjes, Mike P. [University of Bonn, Department of Radiology/Neuroradiology, Bonn (Germany); VU University Medical Center, MS Center Amsterdam, Department of Radiology, Amsterdam (Netherlands); Harzheim, Michael; Schmidt, Stephan [University of Bonn, Department of Neurology, Bonn (Germany); Lutterbey, Goetz G.; Schild, Hans H.; Traeber, Frank [University of Bonn, Department of Radiology/Neuroradiology, Bonn (Germany); Bogdanow, Manuela [University of Bonn, Department of Medical Biometrics, Informatics and Epidemiology, Bonn (Germany)

2008-02-15

The aim of this study was to determine the prognostic value of metabolic alterations in the normal-appearing white matter (NAWM) of patients presenting with clinically isolated syndromes (CIS) suggestive of multiple sclerosis (MS) with special regard to the prediction of conversion to definite MS. Using a 3T whole-body MR system, a multisequence conventional MRI protocol and single-voxel proton MR spectroscopy (PRESS, repetition time 2000 ms, echo times 38 ms and 140 ms) of the parietal NAWM were performed in 25 patients presenting with CIS at baseline and in 20 controls. Absolute concentrations of N-acetyl-aspartate (tNAA), myo-inositol (Ins), choline (Cho) and creatine (tCr) as well as metabolite ratios were determined. Follow-up including neurological assessment and conventional MRI was performed 3-4 and 6-7 months after the initial event. Nine patients converted to definite MS during the follow-up period. Compared to controls, those patients who converted to MS also showed significantly lower tNAA concentrations in the NAWM (-13.4%, P = 0.002) whereas nonconverters (-6.5%, P = 0.052) did not. The Ins concentration was 20.2% higher in the converter group and 1.9% higher in the nonconverter group, but these differences did not reach significance. No significant differences could be observed for tCr and Cho in either patient group. Axonal damage at baseline in patients presenting with CIS was more prominent in those who subsequently converted to definite MS in the short term follow-up, indicating that tNAA might be a sufficient prognostic marker for patients with a higher risk of conversion to early definite MS. (orig.)

Prognostic value of high-field proton magnetic resonance spectroscopy in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis

International Nuclear Information System (INIS)

Wattjes, Mike P.; Harzheim, Michael; Schmidt, Stephan; Lutterbey, Goetz G.; Schild, Hans H.; Traeber, Frank; Bogdanow, Manuela

2008-01-01

The aim of this study was to determine the prognostic value of metabolic alterations in the normal-appearing white matter (NAWM) of patients presenting with clinically isolated syndromes (CIS) suggestive of multiple sclerosis (MS) with special regard to the prediction of conversion to definite MS. Using a 3T whole-body MR system, a multisequence conventional MRI protocol and single-voxel proton MR spectroscopy (PRESS, repetition time 2000 ms, echo times 38 ms and 140 ms) of the parietal NAWM were performed in 25 patients presenting with CIS at baseline and in 20 controls. Absolute concentrations of N-acetyl-aspartate (tNAA), myo-inositol (Ins), choline (Cho) and creatine (tCr) as well as metabolite ratios were determined. Follow-up including neurological assessment and conventional MRI was performed 3-4 and 6-7 months after the initial event. Nine patients converted to definite MS during the follow-up period. Compared to controls, those patients who converted to MS also showed significantly lower tNAA concentrations in the NAWM (-13.4%, P = 0.002) whereas nonconverters (-6.5%, P = 0.052) did not. The Ins concentration was 20.2% higher in the converter group and 1.9% higher in the nonconverter group, but these differences did not reach significance. No significant differences could be observed for tCr and Cho in either patient group. Axonal damage at baseline in patients presenting with CIS was more prominent in those who subsequently converted to definite MS in the short term follow-up, indicating that tNAA might be a sufficient prognostic marker for patients with a higher risk of conversion to early definite MS. (orig.)

A Framework to Support the Sharing and Reuse of Computable Phenotype Definitions Across Health Care Delivery and Clinical Research Applications.

Science.gov (United States)

Richesson, Rachel L; Smerek, Michelle M; Blake Cameron, C

2016-01-01

The ability to reproducibly identify clinically equivalent patient populations is critical to the vision of learning health care systems that implement and evaluate evidence-based treatments. The use of common or semantically equivalent phenotype definitions across research and health care use cases will support this aim. Currently, there is no single consolidated repository for computable phenotype definitions, making it difficult to find all definitions that already exist, and also hindering the sharing of definitions between user groups. Drawing from our experience in an academic medical center that supports a number of multisite research projects and quality improvement studies, we articulate a framework that will support the sharing of phenotype definitions across research and health care use cases, and highlight gaps and areas that need attention and collaborative solutions. An infrastructure for re-using computable phenotype definitions and sharing experience across health care delivery and clinical research applications includes: access to a collection of existing phenotype definitions, information to evaluate their appropriateness for particular applications, a knowledge base of implementation guidance, supporting tools that are user-friendly and intuitive, and a willingness to use them. We encourage prospective researchers and health administrators to re-use existing EHR-based condition definitions where appropriate and share their results with others to support a national culture of learning health care. There are a number of federally funded resources to support these activities, and research sponsors should encourage their use.

The Diagnostic importance of clinical and radiologic features of the Multiple Cemento-osseous dysplasia

International Nuclear Information System (INIS)

Han, M. R.; Kim, Y. H.; Kang, B. C.

1998-01-01

This case was diagnosed as multiple cementoosseous dysplasia on the basis of clinical and radiological features but was diagnosed as ossifying fibroma on the basis of histopathological feature. The histopathologic features of the multiple cementoosseous dysplasia and cementoossifying fibroma have common features of cementum, fibrous network and bone. Multiple cementoosseous dysplasia is reactive lesion and shows restricted lesion size, occurred on anterior and posterior tooth of the mandible and needs no treatment except periodic follow up. But Cementoossifying fibroma is the true neoplasm and grows continuously and needs surgical removal. The final diagnosis of the multiple cementoosseous dysplasia requires good correlation of the clinical histopathological, and radiological features.

Halitosis: a new definition and classification.

Science.gov (United States)

Aydin, M; Harvey-Woodworth, C N

2014-07-11

There is no universally accepted, precise definition, nor standardisation in terminology and classification of halitosis. To propose a new definition, free from subjective descriptions (faecal, fish odour, etc), one-time sulphide detector readings and organoleptic estimation of odour levels, and excludes temporary exogenous odours (for example, from dietary sources). Some terms previously used in the literature are revised. A new aetiologic classification is proposed, dividing pathologic halitosis into Type 1 (oral), Type 2 (airway), Type 3 (gastroesophageal), Type 4 (blood-borne) and Type 5 (subjective). In reality, any halitosis complaint is potentially the sum of these types in any combination, superimposed on the Type 0 (physiologic odour) present in health. This system allows for multiple diagnoses in the same patient, reflecting the multifactorial nature of the complaint. It represents the most accurate model to understand halitosis and forms an efficient and logical basis for clinical management of the complaint.

Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition

DEFF Research Database (Denmark)

Zannad, F.; Stough, W.G.; Pitt, B.

2008-01-01

Specific criteria have been established to define the occurrence of myocardial infarction (MI) and stroke in cardiovascular clinical trials, but there is not a consistent definition for heart failure. Heart failure events appear to occur at a rate that is similar to stroke and MI in trials...... of hypertension, hyperlipidaemia, diabetes, and coronary heart disease, yet a consistent approach to defining heart failure events has not yet been realized. The wide range of definitions used in clinical trials makes it difficult to interpret new data in the context of existing literature. This inconsistency has...... led to challenges in determining the incidence of heart failure in cardiovascular studies and the effects of interventions on these endpoints. This paper examines issues related to defining heart failure events in cardiovascular clinical trials and presents a definition to formally address this issue...

Clinical and MRI features in pediatric multiple sclerosis

International Nuclear Information System (INIS)

Zhao Cailei; Xie Sheng; Xiao Jiangxi; Wang Shuang

2011-01-01

Objective: To investigate the clinical and MRI features of multiple sclerosis in children, including the clinically isolated syndrome (CIS) and relapse. Methods: In total, 16 cases of pediatric multiple sclerosis were included in this study. Of them, 11 patients were female and 5 were male, with the mean onset age of 10.1 years. They were followed up for 4 months to 7 years and found to have 1- 5 relapses. The clinical manifestations of CIS and relapse were analyzed by a pediatric neurologist. An experienced neuroradiologist reviewed the MRI images of CIS and relapse. Information on the location, size, and pattern of the lesions was gathered. The location of lesions included subcortical, central, and periventricular white matter, cortex, deep gray matter, brain stem, and cerebellum. Results: CIS episode presented acute onsets in 13/16 cases, with symptoms of cortices in 10 cases and visual impairment in 6 cases. Relapse occurred in 14/16 cases within one year. The incidence of symptoms of cortices was less frequent and severe in the second episode of MS, whereas the visual impairment had a high incidence. All patients had full recovery after the last episode. MRI of CIS showed confluent subcortical white matter lesions in 13/16 cases, abutting on central white matter lesions. The most frequently involved brain part was the frontal lobe, followed by the parietal lobe. Cortical involvement was observed in 9/16 cases. In 6 cases, periventricular white matter lesions were detected. Bilateral deep gray matter was abnormal in 4 cases. Other abnormalities included brain stem lesions in 5 cases, cerebellum lesions in 3 cases, optic nerve involvement in 3 cases, and pyramidal tract lesions in 2 cases. MRI of relapse revealed more small lesions in the subcortical and periventricular white matter in the patients. In the second episode, only 2 cases presented cortical involvement. Lesions were found in the brain stem in 4 cases and in the cerebellum in 5 cases. Pyramidal tract

CT of multiple sclerosis: reassessment of delayed scanning with high doses of contrast material

International Nuclear Information System (INIS)

Spiegel, S.M.; Vinuela, F.; Fox, A.J.; Pelz, D.M.

1985-01-01

A prospective study involving 87 patients was carried out to evaluate the necessity for a high dose of contrast material in addition to delayed computed tomographic (CT) scanning for optimal detection of the lesions of multiple sclerosis in the brain. In patients with either clinically definite multiple sclerosis or laboratory-supported definite multiple sclerosis, CT scans were obtained with a uniform protocol. Lesions consistent with multiple sclerosis were demonstrated on the second scan in 54 patients. In 36 of these 54 patients, the high-dose delayed scan added information. These results are quite similar to those of a previous study from this institution using different patients, in whom the second scan was obtained immediately after the bolus injection of contrast material containing 40 g of organically bound iodine. The lack of real difference in the results of the two studies indicate that the increased dose, not just the delay in scanning, is necessary for a proper study

Association of definition of acute kidney injury by cystatin C rise with biomarkers and clinical outcomes in children undergoing cardiac surgery.

Science.gov (United States)

Zappitelli, Michael; Greenberg, Jason H; Coca, Steven G; Krawczeski, Catherine D; Li, Simon; Thiessen-Philbrook, Heather R; Bennett, Michael R; Devarajan, Prasad; Parikh, Chirag R

2015-06-01

Research has identified improved biomarkers of acute kidney injury (AKI). Cystatin C (CysC) is a better glomerular filtration rate marker than serum creatinine (SCr) and may improve AKI definition. To determine if defining clinical AKI by increases in CysC vs SCr alters associations with biomarkers and clinical outcomes. Three-center prospective cohort study of intensive care units in New Haven, Connecticut, Cincinnati, Ohio, and Montreal, Quebec, Canada. Participants were 287 patients 18 years or younger without preoperative AKI or end-stage renal disease who were undergoing cardiac surgery. The study dates were July 1, 2007, through December 31, 2009. For biomarker vs clinical AKI associations, the exposures were first postoperative (0-6 hours after surgery) urine interleukin 18, neutrophil gelatinase-associated lipocalin, kidney injury molecule 1, and liver fatty acid-binding protein. For clinical AKI outcome associations, the exposure was Kidney Disease: Improving Global Outcomes AKI definition (based on SCr or CysC). Clinical AKI, length of stay, and length of mechanical ventilation. We determined areas under the receiver operating characteristic curve and odds ratios for first postoperative biomarkers to predict AKI. The SCr-defined vs CysC-defined AKI incidence differed substantially (43.6% vs 20.6%). Percentage agreement was 71% (κ = 0.38); stage 2 or worse AKI percentage agreement was 95%. Interleukin 18 and kidney injury molecule 1 discriminated for CysC-defined AKI better than for SCr-defined AKI. For interleukin 18 and kidney injury molecule 1, the areas under the receiver operating characteristic curve were 0.74 and 0.65, respectively, for CysC-defined AKI, and 0.66 and 0.58, respectively, for SCr-defined AKI. Fifth (vs first) quintile concentrations of both biomarkers were more strongly associated with CysC-defined AKI. For interleukin 18 and kidney injury molecule 1, the odds ratios were 16.19 (95% CI, 3.55-73.93) and 6.93 (95% CI, 1

Clinical and epidemiological features of typhoid fever in Pemba, Zanzibar: assessment of the performance of the WHO case definitions.

Science.gov (United States)

Thriemer, Kamala; Ley, Benedikt; Ley, Benedikt B; Ame, Shaali S; Deen, Jaqueline L; Pak, Gi Deok; Chang, Na Yoon; Hashim, Ramadhan; Schmied, Wolfgang Hellmut; Busch, Clara Jana-Lui; Nixon, Shanette; Morrissey, Anne; Puri, Mahesh K; Ochiai, R Leon; Wierzba, Thomas; Clemens, John D; Ali, Mohammad; Jiddawi, Mohammad S; von Seidlein, Lorenz; Ali, Said M

2012-01-01

The gold standard for diagnosis of typhoid fever is blood culture (BC). Because blood culture is often not available in impoverished settings it would be helpful to have alternative diagnostic approaches. We therefore investigated the usefulness of clinical signs, WHO case definition and Widal test for the diagnosis of typhoid fever. Participants with a body temperature ≥37.5°C or a history of fever were enrolled over 17 to 22 months in three hospitals on Pemba Island, Tanzania. Clinical signs and symptoms of participants upon presentation as well as blood and serum for BC and Widal testing were collected. Clinical signs and symptoms of typhoid fever cases were compared to other cases of invasive bacterial diseases and BC negative participants. The relationship of typhoid fever cases with rainfall, temperature, and religious festivals was explored. The performance of the WHO case definitions for suspected and probable typhoid fever and a local cut off titre for the Widal test was assessed. 79 of 2209 participants had invasive bacterial disease. 46 isolates were identified as typhoid fever. Apart from a longer duration of fever prior to admission clinical signs and symptoms were not significantly different among patients with typhoid fever than from other febrile patients. We did not detect any significant seasonal patterns nor correlation with rainfall or festivals. The sensitivity and specificity of the WHO case definition for suspected and probable typhoid fever were 82.6% and 41.3% and 36.3 and 99.7% respectively. Sensitivity and specificity of the Widal test was 47.8% and 99.4 both forfor O-agglutinin and H- agglutinin at a cut-off titre of 1:80. Typhoid fever prevalence rates on Pemba are high and its clinical signs and symptoms are non-specific. The sensitivity of the Widal test is low and the WHO case definition performed better than the Widal test.

Disability outcome measures in multiple sclerosis clinical trials

DEFF Research Database (Denmark)

Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H

2012-01-01

Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we...

[Chronic pancreatitis: new definition and perspectives.

Science.gov (United States)

Conti Bellocchi, Maria Cristina; De Pretis, Nicolò; Amodio, Antonio; Zerbi, Alessandro; Frulloni, Luca

2018-01-01

Chronic pancreatitis has been considered over the past years as a single disease, alcohol-induced and different from acute pancreatitis, in terms of etiology and prognosis. Actually, the introduction of a new concept of chronic pancreatitis, now considered as a fibroinflammatory process caused by multiple factors (toxic-metabolic, genetic, immunologic, obstructive), allow to better understand the pathogenesis of this complex disease. Furthermore, the discover of peculiar forms of chronic pancreatitis (autoimmune, paraduodenal, associated to gene mutations), different in term of clinical aspects, findings at imaging, prognosis and therapy, radically changed the concept of the disease. In this brief review, we described the impact of this new concept in the comprehension of pathogenesis, in the definition of peculiar forms of chronic pancreatitis, and in the clinical and therapeutic approach of chronic pancreatitis.

Reliability and Clinical Significance of Mobility and Balance Assessments in Multiple Sclerosis

Science.gov (United States)

Learmonth, Yvonne C.; Paul, Lorna; McFadyen, Angus K.; Mattison, Paul; Miller, Linda

2012-01-01

The aim of the study was to establish the test-retest reliability, clinical significance and precision of four mobility and balance measures--the Timed 25-Foot Walk, Six-minute Walk, Timed Up and Go and the Berg Balance Scale--in individuals moderately affected by multiple sclerosis. Twenty four participants with multiple sclerosis (Extended…

Associations of alcohol consumption with clinical and MRI measures in multiple sclerosis

NARCIS (Netherlands)

D'hooghe, Marie B.; De Keyser, Jacques

Evaluation of: Foster M, Zivadinov R, Weinstock-Guttman B et al. Associations of alcohol consumption with clinical and MRI measures in multiple sclerosis. J. Neuroimmunol. 243(1-2), 61-68 (2012). While the harmful effects of alcohol abuse are well documented, experimental and clinical data support a

Clinical characterisation of the multiple maternal hypomethylation syndrome in siblings

DEFF Research Database (Denmark)

Boonen, Susanne E; Pörksen, Sven; Mackay, Deborah Jg

2008-01-01

We present the first clinical report of sibs with the multiple maternal hypomethylation syndrome. Both sisters presented with transient neonatal diabetes mellitus (TNDM). By methylation-specific PCR of bisulphite-treated DNA, we found a mosaic spectrum of hypomethylation at the following maternal...

[Research progress on the clinical value of Ki-67 in breast cancer and its cut-off definition].

Science.gov (United States)

Chen, Qing; Wu, Kejin

2015-08-01

Ki-67 has an important application value in clinical practice. However, it is still a little tough in clinical application because of the debate on the cut-off definition of Ki-67 index. This review summarizes most studies on the prognostic and predictive value of Ki-67, analyzes the reasons for the discrepancies among the studies cited, and presents the necessity and clinical significance of scientifically defining the cut-off of Ki-67 index, providing a theoretical basis for Ki-67 in clinical application.

Clinical definition of respiratory viral infections in young children and potential bronchiolitis misclassification.

Science.gov (United States)

Megalaa, Rosemary; Perez, Geovanny F; Kilaikode-Cheruveettara, Sasikumar; Kotwal, Nidhi; Rodriguez-Martinez, Carlos E; Nino, Gustavo

2018-01-01

Viral respiratory infections are often grouped as a single respiratory syndrome named 'viral bronchiolitis', independently of the viral etiology or individual risk factors. Clinical trials and guidelines have used a more stringent definition of viral bronchiolitis, including only the first episode of wheezing in children less than 12 months of age without concomitant respiratory comorbidities. There is increasing evidence suggesting that this definition is not being followed by pediatric care providers, but it is unclear to what extent viral respiratory infections are currently misclassified as viral bronchiolitis using standard definitions. We conducted a retrospective analysis of hospitalized young children (≤3 years) due to viral respiratory infections. Bronchiolitis was defined as the first wheezing episode less than 12 months of age. Demographic variables and comorbidities were obtained by electronic medical record review. The study comprised a total of 513 hospitalizations (n=453). Viral bronchiolitis was diagnosed in 144 admissions (28.1%). Notably, we identified that the majority of children diagnosed with bronchiolitis (63%) were misclassified as they had prior episodes of wheezing. Many children with bronchiolitis misclassification had significant comorbidities, including prematurity (51%), neuromuscular conditions (9.8%), and congenital heart disease (9.8%). Misclassification of bronchiolitis is a common problem that may lead to inappropriate management of viral respiratory infections in young children. A comprehensive approach that takes into consideration viral etiology and individual risk factors may lead to a more accurate clinical assessment of this condition and would potentially prevent bronchiolitis misclassification. © American Federation for Medical Research (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Spinal cord magnetic resonance imaging in suspected multiple sclerosis

International Nuclear Information System (INIS)

Lycklama a Nijeholt, G.J.; Bergers, E.; Castelijns, J.A.; Barkhof, F.; Uitdehaag, B.M.J.; Polman, C.H.

2000-01-01

We examined the value of spinal cord magnetic resonance imaging (MRI) in the diagnostic work-up of multiple sclerosis (MS). Forty patients suspected of having MS were examined within 24 months after the start of symptoms. Disability was assessed, and symptoms were categorized as either brain or spinal cord. Work-up further included cerebrospinal fluid analysis and standard proton-density, T2-, and T1-weighted gadolinium-enhanced brain and spinal cord MRI. Patients were categorized as either clinically definite MS (n = 13), laboratory-supported definite MS (n = 14), or clinically probable MS (n = 4); four patients had clinically probable MS, and in nine MS was suspected. Spinal cord abnormalities were found in 35 of 40 patients (87.5 %), consisting of focal lesions in 31, only diffuse abnormalities in two, and both in two. Asymptomatic spinal cord lesions occurred in six patients. All patients with diffuse spinal cord abnormality had clear spinal cord symptoms and a primary progressive disease course. In clinically definite MS, the inclusion of spinal imaging increased the sensitivity of MRI to 100 %. Seven patients without a definite diagnosis had clinically isolated syndromes involving the spinal cord. Brain MRI was inconclusive, while all had focal spinal cord lesions which explained symptoms and ruled out other causes. Two other patients had atypical brain abnormalities suggesting ischemic/vascular disease. No spinal cord abnormalities were found, and during follow-up MS was ruled out. Spinal cord abnormalities are common in suspected MS, and may occur asymptomatic. Although diagnostic classification is seldom changed, spinal cord imaging increases diagnostic sensitivity of MRI in patients with suspected MS. In addition, patients with primary progressive MS may possibly be earlier diagnosed. Finally, differentiation with atypical lesions may be improved. (orig.)

Benign multiple sclerosis: a need for a consensus.

Science.gov (United States)

Glad, S B; Aarseth, J H; Nyland, H; Riise, T; Myhr, K-M

2010-01-01

To investigate the impact of different definitions on the frequency of benign multiple sclerosis (MS) in patients with a long follow-up, and to study the presence of non-motor symptoms and employment across the definitions. All patients alive (n = 188) with disease onset during 1976-1986 in Hordaland County, Norway, were clinically examined including the Expanded Disability Status Scale (EDSS) in 2003. Non-motor symptoms which included depression, cognitive impairment, fatigue and pain, and employment status were also registered. Three definitions of benign MS were used based on the following EDSS cut-off values: 2.0, 3.0 and 4.0. Two additional definitions were added using an EDSS part-time employment status. The frequency of benign MS increased from 14.5% for EDSS definition based on full-time employment. Patients with an EDSS

Definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the Gynecological Cancer Intergroup (GCIG)

DEFF Research Database (Denmark)

Rustin, Gordon John Sampson; Vergote, Ignace; Eisenhauer, Elizabeth

2011-01-01

. Thus, we recommend that the definitions described later in detail are incorporated into clinical trial protocols to maintain consistency. The criteria for defining progression are now acceptable in clinical trials of recurrent disease as they have since been validated (Pujade-Lauraine, personal...... communication, 2010). The GCIG requests that data from all clinical trials using these definitions are made available to GCIG trial centers so that continual validation and improvement can be accomplished. These definitions were developed from analyzing patients receiving cytotoxic chemotherapy and have not yet......The Gynecological Cancer Intergroup (GCIG) has previously reached consensus regarding the criteria that should be used in clinical trial protocols to define progression-free survival after first-line therapy as well as the criteria to define response to treatment in recurrent disease using...

Clinical and neurophysiological findings in oligoclonal band negative multiple sclerosis patients

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Mesaroš Šarlota

2003-01-01

Full Text Available Besides magnetic resonance imaging, the presence of locally produced oligoclonal IgG bands (OCB in the cerebrospinal fluid (CSF is the most consistent laboratory abnormality in patients with multiple sclerosis (MS. The most sensitive method for the detection of CSF OCB is isoelectric focusing (IEF [6]. Occasional patients with clinically definite MS lack evidence for intrathecal IgG synthesis [7, 8]. This study was designed to compare clinical data and evoked potential (EP findings between CSF OCB positive and OCB negative MS patients. The study comprised 22 OCB negative patients with clinically definite MS [11] and 22 OCB positive controls matched for age, disease duration, activity and course of MS. In both groups clinical assessment was performed by using Expanded Disability Status Scale (EDSS score [12] and progression rate (PR. All patients underwent multimodal EP: visual (VEPs, brainstem auditory (BAEPs and median somatosensory (mSEPs. The VEPa were considered abnormal if the P100 latency exceeded 117 ms or inter-ocular difference greater than 8 ms was detected. The BAEPs were considered abnormal if waves III or V were absent or the interpeak latencies I-III, III-V, or I-V were increased. The mSEPs were considerd abnormal when N9, N13 and N20 potentials were absent or when increased interpeak latencies were recorded. The severity of the neurophysiological abnormalities was scored for each modality as follows normal EP score 0; every other EP abnormality except the absence of one of the main waves, score 1; absence of one or more of the main waves, score 2 [13]. Both mean EDSS score (4.0 vs. 3.5 and PR (0.6 vs. 0.5 were similar in OCB positive and OCB negative group, (p>0.05. In the first group males were predominant, but without statistical significance (Table 1. Disease started more often with the brainstem symptoms in the OCB positive than in OCB negative MS group (p=0.028, while there was no differences in other initial symptoms between

Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

Science.gov (United States)

Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

2016-03-01

[Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists.

Brief multiple behavior interventions in a college student health care clinic.

Science.gov (United States)

Werch, Chudley E Chad; Bian, Hui; Moore, Michele J; Ames, Steve; DiClemente, Carlo C; Weiler, Robert M

2007-12-01

This study examined the effects of brief image-based interventions, including a multiple behavior health contract, a one-on-one tailored consultation, and a combined consultation plus contract intervention, for impacting multiple health behaviors of students in a university health clinic. A total of 155 college students attending a major southern university were recruited to participate in a study evaluating a health promotion program titled Project Fitness during the fall 2005 and spring 2006. Participants were randomly assigned to one of three treatments as they presented at the clinic: 1) a multiple behavior health contract, 2) a one-on-one tailored consultation, or 3) a combined consultation plus contract intervention. Baseline and 1-month post-intervention data were collected using computer-assisted questionnaires in a quiet office within the student health clinic. Omnibus repeated-measures analyses of variance were significant for drinking driving behaviors, F(2,136) = 4.43, p = .01, exercise behaviors, F(5,140) = 6.12, p = .00, nutrition habits, F(3,143) = 5.37, p = .00, sleep habits, F(2,144) = 5.03, p = .01, and health quality of life, F(5,140) = 3.09, p = .01, with improvements on each behavior across time. Analysis of group-by-time interaction effects showed an increase in the use of techniques to manage stress, F(2,144) = 5.48, p = .01, and the number of health behavior goals set in the last 30 days, F(2,143) = 5.35, p = .01, but only among adolescents receiving the consultation, or consultation plus contract. Effect sizes were consistently larger across health behaviors, and medium in size, when both consult and contract were used together. Brief interventions using a positive goal image of fitness, and addressing a number of health habits using a contract and consultation strategy alone, or in combination, have the potential to influence positive changes in multiple health behaviors of college students attending a university primary health care clinic.

Statin intolerance - a question of definition.

Science.gov (United States)

Algharably, Engi Abdel-Hady; Filler, Iris; Rosenfeld, Stephanie; Grabowski, Katja; Kreutz, Reinhold

2017-01-01

Statin therapy is the backbone of pharmacologic therapy for low-density lipoproteins cholesterol lowering and plays a pivotal role in cardiovascular disease prevention. Statin intolerance is understood as the inability to continue using a statin to reduce individual cardiovascular risk sufficiently, due to the development of symptoms or laboratory abnormalities attributable to the initiation or dose escalation of a statin. Muscle symptoms are the most common side effects observed. Areas covered: The main aim of this article is to present a review on published definitions of statin intolerance. In addition, a brief review on clinical aspects and risk factors of statin intolerance is provided and features for a common definition for statin intolerance are suggested. Expert opinion: A definition of statin intolerance by major drug regulatory agencies is not available. In clinical studies, different definitions are chosen and results are not comparable; different medical associations do not agree on one common definition. There is an unmet need to establish a common definition of statin intolerance to ensure an appropriate clinical use of this important drug class. Further work is required to develop a consensus definition on statin intolerance that could have significant positive impact on both research and clinical management.

Multiple myeloma in Nigeria: An insight to the clinical, laboratory ...

African Journals Online (AJOL)

... the clinician to investigate along the lines of MM. Majority of patients have osteolytic lesions on X‑ray and pathological fractures, and benefit from melphalan based combinations in situations where facilities for transplant are not available. Key words: Clinical features, chemotherapy, laboratory features, multiple myeloma, ...

Clinical judgement within the South African clinical nursing environment: A concept analysis

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Anna C. van Graan

2016-10-01

Full Text Available Reform in the South African healthcare and educational system were characterized by the ideals that the country needs to produce independent, critical thinkers. Nurses need to cope with diversity in a more creative way, defining their role in a complex, uncertain, rapidly changing health care environment. Quality clinical judgement is therefore imperative as an identified characteristic of newly qualified professional nurses. The objective of this study was to explore and describe clinical judgement through various data sources and review of literature to clarify the meaning and promote a common understanding through formulating the characteristics and developing a connotative (theoretical definition of the concept. An explorative, descriptive qualitative design was used to discover the complexity and meaning of the phenomenon. Multiple data sources and search strategies were used, for the time frame 1982—2013. A concept analysis was used to arrive at a theoretical definition of the concept of ‘clinical judgement’ as a complex cognitive skill to evaluate patient needs, adaption of current treatment protocols as well as new treatment strategies, prevention of adverse side effects through being proactive rather than reactive within the clinical nursing environment. The findings emphasized clinical judgement as skill within the clinical nursing environment, thereby improving autonomous and accountable nursing care. These findings will assist nurse leaders and clinical nurse educators in developing a teaching-learning strategy to promote clinical judgement in undergraduate nursing students, thereby contributing to the quality of nursing care.

Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI).

Science.gov (United States)

Moussa, Issam D; Klein, Lloyd W; Shah, Binita; Mehran, Roxana; Mack, Michael J; Brilakis, Emmanouil S; Reilly, John P; Zoghbi, Gilbert; Holper, Elizabeth; Stone, Gregg W

2014-01-01

Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5) which are of uncertain prognostic importance. In addition, for both MI types cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than employing an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a "clinically relevant MI." The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG) which is applicable for use in clinical trials, patient care, and quality outcomes assessment. Copyright © 2013 Wiley Periodicals, Inc.

Clinical Reasoning in Athletic Training Education: Modeling Expert Thinking

Science.gov (United States)

Geisler, Paul R.; Lazenby, Todd W.

2009-01-01

Objective: To address the need for a more definitive approach to critical thinking during athletic training educational experiences by introducing the clinical reasoning model for critical thinking. Background: Educators are aware of the need to teach students how to think critically. The multiple domains of athletic training are comprehensive and…

Target volume definition for external beam partial breast radiotherapy: Clinical, pathological and technical studies informing current approaches

International Nuclear Information System (INIS)

Kirby, Anna M.; Coles, Charlotte E.; Yarnold, John R.

2010-01-01

Partial breast irradiation (PBI) is currently under investigation in several phase III trials and, following a recent consensus statement, its use off-study may increase despite ongoing uncertainty regarding optimal target volume definition. We review the clinical, pathological and technical evidence for target volume definition in external beam partial breast irradiation (EB-PBI). The optimal method of tumour bed (TB) delineation requires X-ray CT imaging of implanted excision cavity wall markers. The definition of clinical target volume (CTV) as TB plus concentric 15 mm margins is based on the anatomical distribution of multifocal and multicentric disease around the primary tumour in mastectomy specimens, and the clinical locations of local tumour relapse (LR) after breast conservation surgery. If the majority of LR originate from foci of residual invasive and/or intraduct disease in the vicinity of the TB after complete microscopic resection, CTV margin logically takes account of the position of primary tumour within the surgical resection specimen. The uncertain significance of independent primary tumours as sources of preventable LR, and of wound healing responses in stimulating LR, increases the difficulties in defining optimal CTV. These uncertainties may resolve after long-term follow-up of current PBI trials. By contrast, a commonly used 10 mm clinical to planning target volume (PTV) margin has a stronger evidence base, although departmental set-up errors need to be confirmed locally. A CTV-PTV margin >10 mm may be required in women with larger breasts and/or large seromas, whilst the role of image-guided radiotherapy with or without TB markers in reducing CTV-PTV margins needs to be explored.

Fabrication of a 3D Printing Definitive Obturator Prosthesis: a Clinical Report

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Georgios Kouveliotis

2017-01-01

Full Text Available Introduction: Digital technologies related to imaging and manufacturing provide the clinician with a wide variety of treatment options. Stereolithography (SLA offers a simple and predictable way for an accurate reconstruction of congenital or acquired defects. Clinical case: A 65-years old cancer patient with non- keratinized squamous cell carcinoma of left maxillary sinus came for a prosthetic clinical evaluation. A bilateral maxillectomy was performed and the treatment plan included definite obturator prosthesis for the upper arch. CT data and 3D planning software were used to create a 3D printing plastic model of the defect. A wax pattern of the hollow bulb was fabricated and cured with heatcured silicone soft liner. A final impression was obtained with the hollow bulb placed intraorally. The master cast was duplicated and the new cast was invested and reflasked. The flasks were opened, wax was boiled out and some space was created in the internal part of the obturator. Transparent heat cured acrylic resin was sandwiched with, at the inner part of the bulb, improving the retention between the acrylic denture base and the silicone based soft lining material. The patient was then placed on a 6-month recall. The five-year follow up consists of a chair side relining, when needed, of the definite removable prostheses. Conclusion: Maxillofacial surgery patients may develop postoperative complications such as trismus and pain. In these cases, the combination of digital technology and conventional techniques provide an accurate prosthetic restoration.

Automatic segmentation of male pelvic anatomy on computed tomography images: a comparison with multiple observers in the context of a multicentre clinical trial.

Science.gov (United States)

Geraghty, John P; Grogan, Garry; Ebert, Martin A

2013-04-30

This study investigates the variation in segmentation of several pelvic anatomical structures on computed tomography (CT) between multiple observers and a commercial automatic segmentation method, in the context of quality assurance and evaluation during a multicentre clinical trial. CT scans of two prostate cancer patients ('benchmarking cases'), one high risk (HR) and one intermediate risk (IR), were sent to multiple radiotherapy centres for segmentation of prostate, rectum and bladder structures according to the TROG 03.04 "RADAR" trial protocol definitions. The same structures were automatically segmented using iPlan software for the same two patients, allowing structures defined by automatic segmentation to be quantitatively compared with those defined by multiple observers. A sample of twenty trial patient datasets were also used to automatically generate anatomical structures for quantitative comparison with structures defined by individual observers for the same datasets. There was considerable agreement amongst all observers and automatic segmentation of the benchmarking cases for bladder (mean spatial variations segmenting a prostate with considerably more volume (mean +113.3%) than that automatically segmented. Similar results were seen across the twenty sample datasets, with disagreement between iPlan and observers dominant at the prostatic apex and superior part of the rectum, which is consistent with observations made during quality assurance reviews during the trial. This study has demonstrated quantitative analysis for comparison of multi-observer segmentation studies. For automatic segmentation algorithms based on image-registration as in iPlan, it is apparent that agreement between observer and automatic segmentation will be a function of patient-specific image characteristics, particularly for anatomy with poor contrast definition. For this reason, it is suggested that automatic registration based on transformation of a single reference dataset

Clinical malaria case definition and malaria attributable fraction in the highlands of western Kenya.

Science.gov (United States)

Afrane, Yaw A; Zhou, Guofa; Githeko, Andrew K; Yan, Guiyun

2014-10-15

In African highland areas where endemicity of malaria varies greatly according to altitude and topography, parasitaemia accompanied by fever may not be sufficient to define an episode of clinical malaria in endemic areas. To evaluate the effectiveness of malaria interventions, age-specific case definitions of clinical malaria needs to be determined. Cases of clinical malaria through active case surveillance were quantified in a highland area in Kenya and defined clinical malaria for different age groups. A cohort of over 1,800 participants from all age groups was selected randomly from over 350 houses in 10 villages stratified by topography and followed for two-and-a-half years. Participants were visited every two weeks and screened for clinical malaria, defined as an individual with malaria-related symptoms (fever [axillary temperature≥37.5°C], chills, severe malaise, headache or vomiting) at the time of examination or 1-2 days prior to the examination in the presence of a Plasmodium falciparum positive blood smear. Individuals in the same cohort were screened for asymptomatic malaria infection during the low and high malaria transmission seasons. Parasite densities and temperature were used to define clinical malaria by age in the population. The proportion of fevers attributable to malaria was calculated using logistic regression models. Incidence of clinical malaria was highest in valley bottom population (5.0% cases per 1,000 population per year) compared to mid-hill (2.2% cases per 1,000 population per year) and up-hill (1.1% cases per 1,000 population per year) populations. The optimum cut-off parasite densities through the determination of the sensitivity and specificity showed that in children less than five years of age, 500 parasites per μl of blood could be used to define the malaria attributable fever cases for this age group. In children between the ages of 5-14, a parasite density of 1,000 parasites per μl of blood could be used to define the

Multiple daily fractionation in radiotherapy: biological rationale and preliminary clinical experiences

Energy Technology Data Exchange (ETDEWEB)

Arcangeli, G [Instituto Medico Scientifico, Rome (Italy). Dept. of Oncology; Mauro, F; Morelli, D; Nervi, C

1979-09-01

The biological bases of radiation dose fractionation are reviewed and discussed with special emphasis on reassortment. Experimental data on animal model systems are presented to clarify that reassortment has to be added to sublethal damage repair and reoxygenation in the rationale for an optimized radiotherapy course according to tumor cell kinetics. Clinical results on several human tumors treated with twice or thrice daily fractions are described. These results show that some clinically radioresistant tumors (especially if not characterized by a relatively long clinical doubling line) can be satisfactorily dealt with using multiple daily fractionation. Clinical observations indicate that a relatively high cumulative daily dose (200 + 150 + 150 rad) can be safely administered.

Multimodal Definition: The Multiplication of Meaning in Electronic ...

African Journals Online (AJOL)

In a multimodal definition, a dynamic meaning ecology can be formed, with two critical variables functioning, (semiotic) mode selection and intermodal synergy. In this ecology, meaning expressed verbally can be multiplied in four dimensions: content, form, space and time. Future directions for research are discussed, ...

Patient subgroup analyses of the treatment effect of subcutaneous interferon beta-1a on development of multiple sclerosis in the randomized controlled REFLEX study

NARCIS (Netherlands)

Freedman, M.S.; De Stefano, N.; Barkhof, F.; Polman, C.H.; Comi, G.; Uitdehaag, B.M.J.; Casset-Semanaz, F.; Hennessy, B.; Lehr, L.; Stubinski, B.; Jack, D.L.; Kappos, L.

2014-01-01

The REFLEX study (NCT00404352) established that subcutaneous (sc) interferon (IFN) β-1a reduced the risks of McDonald MS (2005 criteria) and clinically definite multiple sclerosis (CDMS) in patients with a first clinical demyelinating event suggestive of MS. The aim of this subgroup analysis was to

Acute disseminated encephalomyelitis in children: differential diagnosis from multiple sclerosis on the basis of clinical course

Directory of Open Access Journals (Sweden)

Yun Jin Lee

2011-06-01

Full Text Available Acute disseminated encephalomyelitis (ADEM is a demyelinating disease of the central nervous system (CNS that typically presents as a monophasic disorder associated with multifocal neurologic symptoms and encephalopathy. ADEM is considered an autoimmune disorder that is triggered by an environmental stimulus in genetically susceptible individuals. The diagnosis of ADEM is based on clinical and radiological features. Most children with ADEM initially present with fever, meningeal signs, and acute encephalopathy. The level of consciousness ranges from lethargy to frank coma. Deep and subcortical white-matter lesions and gray-matter lesions such as thalami and basal ganglia on magnetic resonance imaging (MRI are associated with ADEM. In a child who presents with signs of encephalitis, bacterial and viral meningitis or encephalitis must be ruled out. Sequential MRI is required to confirm the diagnosis of ADEM, as relapses with the appearance of new lesions on MRI may suggest either multiphasic ADEM or multiple sclerosis (MS. Pediatric MS, defined as onset of MS before the age of 16, is being increasingly recognized. MS is characterized by recurrent episodes of demyelination in the CNS separated in space and time. The McDonald criteria for diagnosis of MS include evidence from MRI and allow the clinician to make a diagnosis of clinically definite MS on the basis of the interval preceding the development of new white matter lesions, even in the absence of new clinical findings. The most important alternative diagnosis to MS is ADEM. At the initial presentation, the 2 disorders cannot be distinguished with certainty. Therefore, prolonged follow-up is needed to establish a diagnosis.

Development of a validated clinical case definition of generalized tonic-clonic seizures for use by community-based health care providers.

Science.gov (United States)

Anand, Krishnan; Jain, Satish; Paul, Eldho; Srivastava, Achal; Sahariah, Sirazul A; Kapoor, Suresh K

2005-05-01

To develop and test a clinical case definition for identification of generalized tonic-clonic seizures (GTCSs) by community-based health care providers. To identify symptoms that can help identify GTCSs, patients with history of a jerky movements or rigidity in any part of the body ever in life were recruited from three sites: the community, secondary care hospital, and tertiary care hospital. These patients were administered a 14-item structured interview schedule focusing on the circumstances surrounding the seizure. Subsequently, a neurologist examined each patient and, based on available investigations, classified them as GTCS or non-GTCS cases. A logistic regression analysis was performed to select symptoms that were to be used for case definition of GTCSs. Validity parameters for the case definition at different cutoff points were calculated in another set of subjects. In total, 339 patients were enrolled in the first phase of the study. The tertiary care hospital contributed the maximal number of GTCS cases, whereas cases of non-GTCS were mainly from the community. At the end of phase I, the questionnaire was shortened from 14 to eight questions based on statistical association and clinical judgment. After phase II, which was conducted among 170 subjects, three variables were found to be significantly related to the presence of GTCSs by logistic regression: absence of stress (13.1; 4.1-41.3), presence of frothing (13.7; 4.0-47.3), and occurrence in sleep (8.3; 2.0-34.9). As a case definition using only three variables did not provide sufficient specificity, three more variables were added based on univariate analysis of the data (incontinence during the episode and unconsciousness) and review of literature (injury during episode). A case definition consisting of giving one point to an affirmative answer for each of the six questions was tested. At a cutoff point of four, sensitivity was 56.9 (47.4-66.0) and specificity, 96.3 (86.2-99.4). Among the 197 GTCS

75 FR 69591 - Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug...

Science.gov (United States)

2010-11-15

..., Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs AGENCY: Centers for Medicare... withdrawing the definition of ``multiple source drug'' as it was revised in the ``Medicaid Program; Multiple Source Drug Definition'' final rule published in the October 7, 2008 Federal Register. DATES: Effective...

The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

Science.gov (United States)

Singer, Mervyn; Deutschman, Clifford S; Seymour, Christopher Warren; Shankar-Hari, Manu; Annane, Djillali; Bauer, Michael; Bellomo, Rinaldo; Bernard, Gordon R; Chiche, Jean-Daniel; Coopersmith, Craig M; Hotchkiss, Richard S; Levy, Mitchell M; Marshall, John C; Martin, Greg S; Opal, Steven M; Rubenfeld, Gordon D; van der Poll, Tom; Vincent, Jean-Louis; Angus, Derek C

2016-02-23

Definitions of sepsis and septic shock were last revised in 2001. Considerable advances have since been made into the pathobiology (changes in organ function, morphology, cell biology, biochemistry, immunology, and circulation), management, and epidemiology of sepsis, suggesting the need for reexamination. To evaluate and, as needed, update definitions for sepsis and septic shock. A task force (n = 19) with expertise in sepsis pathobiology, clinical trials, and epidemiology was convened by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine. Definitions and clinical criteria were generated through meetings, Delphi processes, analysis of electronic health record databases, and voting, followed by circulation to international professional societies, requesting peer review and endorsement (by 31 societies listed in the Acknowledgment). Limitations of previous definitions included an excessive focus on inflammation, the misleading model that sepsis follows a continuum through severe sepsis to shock, and inadequate specificity and sensitivity of the systemic inflammatory response syndrome (SIRS) criteria. Multiple definitions and terminologies are currently in use for sepsis, septic shock, and organ dysfunction, leading to discrepancies in reported incidence and observed mortality. The task force concluded the term severe sepsis was redundant. Sepsis should be defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. For clinical operationalization, organ dysfunction can be represented by an increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more, which is associated with an in-hospital mortality greater than 10%. Septic shock should be defined as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock

The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

Science.gov (United States)

Singer, Mervyn; Deutschman, Clifford S.; Seymour, Christopher Warren; Shankar-Hari, Manu; Annane, Djillali; Bauer, Michael; Bellomo, Rinaldo; Bernard, Gordon R.; Chiche, Jean-Daniel; Coopersmith, Craig M.; Hotchkiss, Richard S.; Levy, Mitchell M.; Marshall, John C.; Martin, Greg S.; Opal, Steven M.; Rubenfeld, Gordon D.; van der Poll, Tom; Vincent, Jean-Louis; Angus, Derek C.

2016-01-01

IMPORTANCE Definitions of sepsis and septic shock were last revised in 2001. Considerable advances have since been made into the pathobiology (changes in organ function, morphology, cell biology, biochemistry, immunology, and circulation), management, and epidemiology of sepsis, suggesting the need for reexamination. OBJECTIVE To evaluate and, as needed, update definitions for sepsis and septic shock. PROCESS A task force (n = 19) with expertise in sepsis pathobiology, clinical trials, and epidemiology was convened by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine. Definitions and clinical criteria were generated through meetings, Delphi processes, analysis of electronic health record databases, and voting, followed by circulation to international professional societies, requesting peer review and endorsement (by 31 societies listed in the Acknowledgment). KEY FINDINGS FROMEVIDENCE SYNTHESIS Limitations of previous definitions included an excessive focus on inflammation, the misleading model that sepsis follows a continuum through severe sepsis to shock, and inadequate specificity and sensitivity of the systemic inflammatory response syndrome (SIRS) criteria. Multiple definitions and terminologies are currently in use for sepsis, septic shock, and organ dysfunction, leading to discrepancies in reported incidence and observed mortality. The task force concluded the term severe sepsis was redundant. RECOMMENDATIONS Sepsis should be defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. For clinical operationalization, organ dysfunction can be represented by an increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more, which is associated with an in-hospital mortality greater than 10%. Septic shock should be defined as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a

Morphological and clinical aspects of the occurrence of accessory (multiple) renal arteries

Science.gov (United States)

Gulas, Ewelina; Wysiadecki, Grzegorz; Szymański, Jacek; Majos, Agata; Stefańczyk, Ludomir; Topol, Mirosław

2016-01-01

Renal vascularization variants vastly differ between individuals due to the very complex embryogenesis of the kidneys. Moreover, each variant may have implications for clinical and surgical interventions. The number of operating procedures continues to grow, and includes renal transplants, aneurysmorrhaphy and other vascular reconstructions. In any surgical technique, unawareness of the presence of multiple renal arteries may result in a fatal outcome, especially if laparoscopic methods are used. The aim of this review is to comprehensively identify the variation within multiple renal arteries and to highlight the connections between the presence of accessory renal arteries and the coexistence of other variants of vascularization. Another aim is to determine the potential clinical implications of the presence of accessory renal arteries. This study is of particular importance for surgeons, intervention radiologists, nephrologists and vascular surgeons. PMID:29593819

Does vitamin D deficiency predict early conversion of clinically isolated syndrome? A preliminary Egyptian study.

Science.gov (United States)

Shaheen, Hala A; Sayed, Sayed S; Daker, Lamiaa I; AbdelAziz, Hossam Eldin; Taha, Mohamed A

2018-03-15

It has been suggested that vitamin D influences the immunoregulation and subsequently affects the risk for conversion of clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (MS). There is little information regarding the relationship between levels of vitamin D and CIS conversion to MS in Egyptian patients. It is to study contribution of vitamin D deficiency to conversion of CIS to clinically definite multiple sclerosis (CDMS) and correlation of vitamin D level to cognitive and magnetic resonance imaging (MRI) results. A longitudinal prospective case control study was conducted on 43 Egyptian patients diagnosed as CIS according to McDonald criteria (2010). Clinical presentation, brain MRI and 25-hydroxyvitamin D levels were evaluated at baseline and after one-year follow-up. The CIS patients that converted to MS showed significant lower vitamin D level (p < 0.001) than the non-convertors. Multivariate logistic regression analysis revealed that the CIS patients with lower 25-hydroxyvitamin D level (p < 0.001) are at higher risk for early conversion to MS. There was a significant positive correlation between the vitamin D level and PASAT (r = 0.36, p = 0.02). It was found that there was a significant negative correlation between vitamin D level and MRI T 2 load (r = -0.38, p = 0.01). The low level of 25-hydroxyvitamin D may predict early conversion to clinically definite MS. Early vitamin D supplementation is recommended in patients with CIS.

Comparison of biochemical failure definitions for permanent prostate brachytherapy

International Nuclear Information System (INIS)

Kuban, Deborah A.; Levy, Larry B.; Potters, Louis; Beyer, David C.; Blasko, John C.; Moran, Brian J.; Ciezki, Jay P.; Zietman, Anthony L.; Zelefsky, Michael J.; Pisansky, Thomas M.; Elshaikh, Mohamed; Horwitz, Eric M.

2006-01-01

Purpose: To assess prostate-specific antigen (PSA) failure definitions for patients with Stage T1-T2 prostate cancer treated by permanent prostate brachytherapy. Methods and Materials: A total of 2,693 patients treated with radioisotopic implant as solitary treatment for T1-T2 prostatic adenocarcinoma were studied. All patients had a pretreatment PSA, were treated at least 5 years before analysis, 1988 to 1998, and did not receive hormonal therapy before recurrence. Multiple PSA failure definitions were tested for their ability to predict clinical failure. Results: Definitions which determined failure by a certain increment of PSA rise above the lowest PSA level to date (nadir + x ng/mL) were more sensitive and specific than failure definitions based on PSA doubling time or a certain number of PSA rises. The sensitivity and specificity for the nadir + 2 definition were 72% and 83%, vs. 51% and 81% for 3 PSA rises. The surgical type definitions (PSA exceeding an absolute value) could match this sensitivity and specificity but only when failure was defined as exceeding a PSA level in the 1-3 ng/mL range and only when patients were allowed adequate time to nadir. When failure definitions were compared by time varying covariate regression analysis, nadir + 2 ng/mL retained the best fit. Conclusions: For patients treated by permanent radioisotopic implant for prostate cancer, the definition nadir + 2 ng/mL provides the best surrogate for failure throughout the entire follow-up period, similar to patients treated by external beam radiotherapy. Therefore, the same PSA failure definition could be used for both modalities. For brachytherapy patients with long-term follow-up, at least 6 years, defining failure as exceeding an absolute PSA level in the 0.5 ng/mL range may be reasonable

Revised definition of neuropathic pain and its grading system: an open case series illustrating its use in clinical practice.

Science.gov (United States)

Geber, Christian; Baumgärtner, Ulf; Schwab, Rainer; Müller, Harald; Stoeter, Peter; Dieterich, Marianne; Sommer, Clemens; Birklein, Frank; Treede, Rolf-Detlef

2009-10-01

The definition of neuropathic pain has recently been revised by an expert committee of the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain (NeuPSIG) as "pain arising as direct consequence of a lesion or disease affecting the somatosensory system," and a grading system of "definite," "probable," and "possible" neuropathic pain has been introduced. This open case series of 5 outpatients (3 men, 2 women; mean age 48 +/- 12 years) demonstrates how the grading system can be applied, in combination with appropriate confirmatory testing, to diagnosis neuropathic conditions in clinical practice. The proposed grading system includes a dynamic algorithm that enhances the physician's ability to determine with a greater level of certainty whether a pain condition is neuropathic. Its clinical use should be further validated in prospective studies.

Definition of treatment response in rheumatoid arthritis based on the simplified and the clinical disease activity index.

Science.gov (United States)

Aletaha, Daniel; Martinez-Avila, Jose; Kvien, Tore K; Smolen, Josef S

2012-07-01

The simplified disease activity index (SDAI) and the clinical disease activity index (CDAI) are established instruments to measure disease activity in rheumatoid arthritis (RA). To date, no validated response definitions for the SDAI and CDAI are available. The authors aimed to define minor, moderate and major response criteria for the SDAI. The authors used data from two clinical trials on infliximab versus methotrexate in early (ASPIRE) or established (ATTRACT) RA, and identified the three SDAI cutpoints based on the best agreement (by κ statistics) with the American College of Rheumatology (ACR)20/50/70 responses. Cutpoints were then tested for different aspects of validity in the trial datasets and in a Norwegian disease modifying antirheumatic drug prescription dataset (NOR-DMARD). Based on agreement with the ACR response, the minor, moderate and major responses were identified as SDAI 50%, 70% and 85% improvement. These cutpoints had good face validity concerning the disease activity states achieved by the different response definitions. Construct validity was shown by a clear association of increasing SDAI response categories with increasing levels of functional improvement, achievement of better functional states and lower annual radiographic progression. Across SDAI 50/70/85, the sensitivities regarding a patient-perceived improvement decreased (73%/39%/22%) and the specificities increased (61%/89%/96%) in a meaningful way. Further, the cutpoints discriminated the different treatment arms in ASPIRE and ATTRACT. The same cutpoints were used for the CDAI, with similar results in the validation analyses. These new response criteria expand the usefulness of the SDAI and CDAI for their use as endpoints in clinical trials beyond the definition of disease activity categories.

Functional symptoms in clinically definite MS--pseudo-relapse syndrome.

LENUS (Irish Health Repository)

Merwick, A

2012-02-03

Although the diagnostic criteria for multiple sclerosis (MS) have become more formalized and sensitive in the era of magnetic resonance imaging (MRI) scanning, the assessment of individual relapses may not always be straightforward or easily linked to a particular lesion seen on imaging. In addition, acute episodes often have to be assessed outside of normal working hours or when the individual patients usual medical team is not available. Often the emergency department physicians have little formal neurological training and are under time pressure to get patients through the system as quickly as possible. It is therefore possible to mislabel functional symptoms as being true relapses. To illustrate scenarios of possible pseudo-relapse, three clinical vignettes are described. Misclassification of functional symptoms as relapse carries a number of inherent risks. Functional symptoms can be multifactorial and may cause a burden of disease. A multidisciplinary approach may be useful in minimizing unnecessary harm and identify if there is more than meets the eye to an episode of clinical deterioration.

Adjuvant and Definitive Radiotherapy for Adrenocortical Carcinoma

International Nuclear Information System (INIS)

Sabolch, Aaron; Feng, Mary; Griffith, Kent; Hammer, Gary; Doherty, Gerard; Ben-Josef, Edgar

2011-01-01

Purpose: To evaluate the impact of both adjuvant and definitive radiotherapy on local control of adrenocortical carcinoma. Methods and Materials: Outcomes were analyzed from 58 patients with 64 instances of treatment for adrenocortical carcinoma at the University of Michigan's Multidisciplinary Adrenal Cancer Clinic. Thirty-seven of these instances were for primary disease, whereas the remaining 27 were for recurrent disease. Thirty-eight of the treatment regimens involved surgery alone, 10 surgery plus adjuvant radiotherapy, and 16 definitive radiotherapy for unresectable disease. The effects of patient, tumor, and treatment factors were modeled simultaneously using multiple variable Cox proportional hazards regression for associations with local recurrence, distant recurrence, and overall survival. Results: Local failure occurred in 16 of the 38 instances that involved surgery alone, in 2 of the 10 that consisted of surgery plus adjuvant radiotherapy, and in 1 instance of definitive radiotherapy. Lack of radiotherapy use was associated with 4.7 times the risk of local failure compared with treatment regimens that involved radiotherapy (95% confidence interval, 1.2-19.0; p = 0.030). Conclusions: Radiotherapy seems to significantly lower the risk of local recurrence/progression in patients with adrenocortical carcinoma. Adjuvant radiotherapy should be strongly considered after surgical resection.

Evaluation of an improved technique for automated center lumen line definition in cardiovascular image data

International Nuclear Information System (INIS)

Gratama van Andel, Hugo A.F.; Meijering, Erik; Vrooman, Henri A.; Stokking, Rik; Lugt, Aad van der; Monye, Cecile de

2006-01-01

The aim of the study was to evaluate a new method for automated definition of a center lumen line in vessels in cardiovascular image data. This method, called VAMPIRE, is based on improved detection of vessel-like structures. A multiobserver evaluation study was conducted involving 40 tracings in clinical CTA data of carotid arteries to compare VAMPIRE with an established technique. This comparison showed that VAMPIRE yields considerably more successful tracings and improved handling of stenosis, calcifications, multiple vessels, and nearby bone structures. We conclude that VAMPIRE is highly suitable for automated definition of center lumen lines in vessels in cardiovascular image data. (orig.)

Connected health and multiple sclerosis.

Science.gov (United States)

Cohen, M

2018-04-18

There is as yet no consensual definition of "connected health". In general, the term refers to the growing use of technology and, in particular, mobile technology in medicine. Over the past 10 years, there have been an increasing number of published reports on the wide-ranging and heterogeneous fields involving the application of technology in medicine, ranging from telemedicine to tools to improve patients' evaluation and monitoring by physicians, as well as a multitude of patient-centered applications. They also represent promising tools in the field of clinical research. This report is a review of the importance of using this technology in the management of multiple sclerosis patients. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Magnetic resonance imaging in the diagnosis of multiple sclerosis

International Nuclear Information System (INIS)

Kato, Hiroyuki; Takase, Sadao; Ichikawa, Nobumichi; Yamada, Kenji; Matsuzawa, Taiju.

1987-01-01

Seventeen patients with multiple sclerosis (MS), 11 clinically definite and 6 probable MS, were studied using magnetic resonance imaging (MRI) and other diagnostic techniques including cerebrospinal fluid (CSF) analysis, evoked potentials (EP) and CT. The MRI imager was operated at 0.14 tesla. The Carr-Purcell-Meiboom-Gill pulse sequence was employed and multiple spin echoes were acquired. T 1 and T 2 relaxation times of the MS plaques were calculated. Incidence of MS plaque detection was 82 % in MRI (100 % in definite MS and 50 % in probable MS). Incidence of abnormality was 65 % in CSF analysis (IgG, oligoclonal bands and myelin basic protein), 63 % in EP (auditory evoked brainstem response and somatosensory evoked response), and 24 % in CT. Lesion detection by MRI was more frequent when the patient was diagnosed as clinically definite, when the duration of disease was longer or the exacerbation was more frequent. T 1 and T 2 of the MS plaques were 715 ± 140 msec and 184 ± 42 msec, respectively, and were significantly prolonged compared to normal values (T 1 ; 351 ± 35 msec, T 2 ; 102 ± 12 msec). The relaxation times of the plaques which were detected by CT (T 1 ; 834 ± 106 msec, T 2 ; 216 ± 37 msec) were significantly longer than those which were not detected (T 1 ; 673 ± 128 msec, T 2 ; 165 ± 32 msec). Serial observations of relaxation times showed that they become short as time passes after the onset of symptoms. As a result, MRI was most sensitive among the diagnostic modalities of MS, and the relaxation times can serve as indices of the activity and severity of the disease. (author)

Pulmonary function and dysfunction in multiple sclerosis.

Science.gov (United States)

Smeltzer, S C; Utell, M J; Rudick, R A; Herndon, R M

1988-11-01

Pulmonary function was studied in 25 patients with clinically definite multiple sclerosis with a range of motor impairment. Forced vital capacity (FVC), maximal voluntary ventilation (MVV), and maximal expiratory pressure (MEP) were normal in the ambulatory patients (mean greater than or equal to 80% predicted) but reduced in bedridden patients (mean, 38.5%, 31.6%, and 36.3% predicted; FCV, MVV, and MEP, respectively) and wheelchair-bound patients with upper extremity involvement (mean, 69.4%, 50.4%, and 62.6% predicted; FVC, MVV, and MEP, respectively). Forced vital capacity, MVV, and MEP correlated with Kurtzke Expanded Disability Status scores (tau = -0.72, -0.70, and -0.65) and expiratory muscle weakness occurred most frequently. These findings demonstrate that marked expiratory weakness develops in severely paraparetic patients with multiple sclerosis and the weakness increases as the upper extremities become increasingly involved.

Should clinical case definitions of influenza in hospitalized older adults include fever?

Science.gov (United States)

Falsey, Ann R; Baran, Andrea; Walsh, Edward E

2015-08-01

Influenza is a major cause of morbidity and mortality in elderly persons. Fever is included in all standard definitions of influenza-like illness (ILI), yet older patients may have diminished febrile response to infection. Therefore, we examined the utility of various thresholds to define fever for case definitions of influenza in persons ≥ 65 years of age. Data from two prospective surveillance studies for respiratory viral infection in adults hospitalized with acute cardiopulmonary illnesses with or without fever were examined. The highest temperature reported prior to admission or measured during the first 24 h after admission was recorded. The diagnosis of influenza was made by a combination of viral culture, reverse-transcription polymerase chain reaction, antigen testing, and serology. A total of 2410 subjects (66% ≥ 65 years of age) were enrolled; 281 had influenza (261 influenza A, 19 influenza B, and one mixed influenza A and B). The commonly used definition of ILI (fever ≥ 37·8°C and cough) resulted in 57% sensitivity and 71% specificity in older adults. Receiver operating characteristic curves examining the various temperature thresholds combined with cough and/or sore throat showed the optimal balance between sensitivity and specificity to be 37·9°C (AUC 0·71) and 37·3°C (AUC 0·66), in younger and older persons, respectively. Clinical decision rules using the presence of cough and fever may be helpful when screening for influenza or empiric antiviral treatment when rapid influenza testing is not available; however, lower fever thresholds may be considered for elderly subjects. © 2015 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Terminology development towards harmonizing multiple clinical neuroimaging research repositories.

Science.gov (United States)

Turner, Jessica A; Pasquerello, Danielle; Turner, Matthew D; Keator, David B; Alpert, Kathryn; King, Margaret; Landis, Drew; Calhoun, Vince D; Potkin, Steven G; Tallis, Marcelo; Ambite, Jose Luis; Wang, Lei

2015-07-01

Data sharing and mediation across disparate neuroimaging repositories requires extensive effort to ensure that the different domains of data types are referred to by commonly agreed upon terms. Within the SchizConnect project, which enables querying across decentralized databases of neuroimaging, clinical, and cognitive data from various studies of schizophrenia, we developed a model for each data domain, identified common usable terms that could be agreed upon across the repositories, and linked them to standard ontological terms where possible. We had the goal of facilitating both the current user experience in querying and future automated computations and reasoning regarding the data. We found that existing terminologies are incomplete for these purposes, even with the history of neuroimaging data sharing in the field; and we provide a model for efforts focused on querying multiple clinical neuroimaging repositories.

Proposal for a revised definition of dilated cardiomyopathy, hypokinetic non-dilated cardiomyopathy, and its implications for clinical practice

DEFF Research Database (Denmark)

Pinto, Yigal M; Elliott, Perry M; Arbustini, Eloisa

2016-01-01

In this paper the Working Group on Myocardial and Pericardial Disease proposes a revised definition of dilated cardiomyopathy (DCM) in an attempt to bridge the gap between our recent understanding of the disease spectrum and its clinical presentation in relatives, which is key for early diagnosis...

Design of clinical trials involving multiple hypothesis tests with a common control.

Science.gov (United States)

Schou, I Manjula; Marschner, Ian C

2017-07-01

Randomized clinical trials comparing several treatments to a common control are often reported in the medical literature. For example, multiple experimental treatments may be compared with placebo, or in combination therapy trials, a combination therapy may be compared with each of its constituent monotherapies. Such trials are typically designed using a balanced approach in which equal numbers of individuals are randomized to each arm, however, this can result in an inefficient use of resources. We provide a unified framework and new theoretical results for optimal design of such single-control multiple-comparator studies. We consider variance optimal designs based on D-, A-, and E-optimality criteria, using a general model that allows for heteroscedasticity and a range of effect measures that include both continuous and binary outcomes. We demonstrate the sensitivity of these designs to the type of optimality criterion by showing that the optimal allocation ratios are systematically ordered according to the optimality criterion. Given this sensitivity to the optimality criterion, we argue that power optimality is a more suitable approach when designing clinical trials where testing is the objective. Weighted variance optimal designs are also discussed, which, like power optimal designs, allow the treatment difference to play a major role in determining allocation ratios. We illustrate our methods using two real clinical trial examples taken from the medical literature. Some recommendations on the use of optimal designs in single-control multiple-comparator trials are also provided. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Multiple intraductal papillomas of breast clinically masquerading as malignancy

Directory of Open Access Journals (Sweden)

Singh Pallavi

2010-01-01

Full Text Available Background: Intraductal papilloma is characterized by proliferation of epithelial and myoepithelial cells overlying fibro-vascular stalks creating an arborescent structure within the lumen of duct. Some times multiple papillomas with florid proliferation of epithelium may be confused with malignancy. A case of multiple intraductal papillomas of breast with ulceration of overlying skin and large lump leading to clinical diagnosis of malignancy is documented here. Case Report: A 45-year-old female presented with ulcerated mass of six months duration in the left breast. On examination, a firm, immobile lump of 8× 10 cm in size involving nipple with excoriation of surrounding skin and serosanguinous discharge from nipple was present. There was no axillary lymphadenopathy. No family history of carcinoma breast was present. Fine needle aspiration smears showed benign cellular changes with apocrine metaplasia. Biopsy from an area adjacent to nipple showed intraductal papilloma. Simple mastectomy showed lobulated dirty white mass with well circumscribed nodules below the nipple and areola. On histology with immunohistochemistry a diagnosis of multiple intraductal papillomas was made. Patient is on regular follow-up and doing well. Conclusion: The case highlights the problem in differentiating marked papillomatosis from a malignant lesion of breast and importance of biopsy with immunohistochemistry in such cases for proper management.

Can a science-based definition of acupuncture improve clinical outcomes?

Science.gov (United States)

Priebe, Ted; Stumpf, Steven H; Zalunardo, Rod

2017-05-01

Research on acupuncture has been muddled by attempts to bridge the ancient with the modern. Barriers to effectiveness research are reflected in recurring conflicts that include disagreement on use of the most basic terms, lack of standard intervention controls, and the absence of functional measures for assessing treatment effect. Acupuncture research has stalled at the "placebo barrier" wherein acupuncture is "no better than placebo." The most widely recognized comparative effectiveness research in acupuncture does not compare acupuncture treatment protocols within groups, thereby, mutating large scale effectiveness studies into large scale efficacy trials. Too often research in acupuncture attempts to tie outcomes to traditional belief systems thereby limiting usefulness of the research. The acupuncture research paradigm needs to focus more closely on a scientific definition of treatments and outcomes that compare protocols in terms of prevalent clinical issues such as relative effectiveness for treating pain.

Accuracy of Zika virus disease case definition during simultaneous Dengue and Chikungunya epidemics.

Science.gov (United States)

Braga, José Ueleres; Bressan, Clarisse; Dalvi, Ana Paula Razal; Calvet, Guilherme Amaral; Daumas, Regina Paiva; Rodrigues, Nadia; Wakimoto, Mayumi; Nogueira, Rita Maria Ribeiro; Nielsen-Saines, Karin; Brito, Carlos; Bispo de Filippis, Ana Maria; Brasil, Patrícia

2017-01-01

Zika is a new disease in the American continent and its surveillance is of utmost importance, especially because of its ability to cause neurological manifestations as Guillain-Barré syndrome and serious congenital malformations through vertical transmission. The detection of suspected cases by the surveillance system depends on the case definition adopted. As the laboratory diagnosis of Zika infection still relies on the use of expensive and complex molecular techniques with low sensitivity due to a narrow window of detection, most suspected cases are not confirmed by laboratory tests, mainly reserved for pregnant women and newborns. In this context, an accurate definition of a suspected Zika case is crucial in order for the surveillance system to gauge the magnitude of an epidemic. We evaluated the accuracy of various Zika case definitions in a scenario where Dengue and Chikungunya viruses co-circulate. Signs and symptoms that best discriminated PCR confirmed Zika from other laboratory confirmed febrile or exanthematic diseases were identified to propose and test predictive models for Zika infection based on these clinical features. Our derived score prediction model had the best performance because it demonstrated the highest sensitivity and specificity, 86·6% and 78·3%, respectively. This Zika case definition also had the highest values for auROC (0·903) and R2 (0·417), and the lowest Brier score 0·096. In areas where multiple arboviruses circulate, the presence of rash with pruritus or conjunctival hyperemia, without any other general clinical manifestations such as fever, petechia or anorexia is the best Zika case definition.

Optical Coherence Tomography-A New Diagnostic Tool to Evaluate Axonal Degeneration in Multiple Sclerosis: A Review

Directory of Open Access Journals (Sweden)

Nilüfer Kale

2010-09-01

Full Text Available Multiple sclerosis is an inflammatory demyelinating disorder of the central nervous system with a wide spectrum of clinical signs and symptoms. Multiple sclerosis lesions have a predilection for the optic nerves, periventricular white matter, brainstem, spinal cord, and cerebellum. The mechanisms responsible for multiple sclerosis are complex and heterogeneous across patients and disease stages. No specific markers exist for the definite diagnosis and prognosis of multiple sclerosis. The afferent visual pathway, which extends from the retina to the primary visual cortex including the optic nerve, is one of the most commonly affected sites in multiple sclerosis (94-99%. Pathology of affected optic nerves exhibits inflammation, demyelination, gliosis, axonal injury, and thinning of the retinal nerve fiber layer (RNFL. The RNFL is composed of unmyelinated axons, and measuring RNFL thickness is a viable method to monitor axonal loss reflecting disease progression. Optical coherence tomography is a noninvasive and reproducible tool in assessing the impact of multiple sclerosis on the thickness of the RNFL. Assessment of the afferent visual pathway using clinical, imaging and electrophysiological methods provides insights into the pathophysiology of multiple sclerosis and may also serve a prognostic role in multiple sclerosis

Analysis of underlying and multiple-cause mortality data: the life table methods.

Science.gov (United States)

Moussa, M A

1987-02-01

The stochastic compartment model concepts are employed to analyse and construct complete and abbreviated total mortality life tables, multiple-decrement life tables for a disease, under the underlying and pattern-of-failure definitions of mortality risk, cause-elimination life tables, cause-elimination effects on saved population through the gain in life expectancy as a consequence of eliminating the mortality risk, cause-delay life tables designed to translate the clinically observed increase in survival time as the population gain in life expectancy that would occur if a treatment protocol was made available to the general population and life tables for disease dependency in multiple-cause data.

Multiple intelligences: Can they be measured?

OpenAIRE

Kirsi Tirri; Petri Nokelainen; Erkki Komulainen

2013-01-01

This paper is about issues relating to the assessment of multiple intelligences. The first section introduces the authors’ work on building measures of multiple intelligences and moral sensitivities. It also provides a conceptual definition of multiple intelligences based on Multiple Intelligences theory by Howard Gardner (1983). The second section discusses the context specificity of intelligences and alternative approaches to measuring multiple intelligences. The third section analyses the ...

To the question of definition of fissile material mass and neutron multiplication in deep sub-critical systems

International Nuclear Information System (INIS)

Dulin, V.V.

2006-01-01

A method of determination neutrons multiplication in deep sub-critical multiplying media has been developed. It is based on a modified of Rossi - alpha method. It will consist in use of integral on time (a method of the areas) from correlated parts of distribution and integral in area, independent of time a part of distribution (area of a constant background). It allows to spend the calculated analysis, using the integrated equation on time for a neutrons flux and to not use representation of point kinetic model. A calculation spatially-correlation factor the adjoint (relative the detector count rate) inhomogeneous equation is used. Its calculation takes into account fission both in multiplying media and in a spontaneous neutron source. Measurements with plutonium-steel and uranium-steel blocks, and blocks from uranium and plutonium dioxide of different enrichment are have been carried out. The measured values of neutrons multiplication in a range 1.03-1.82 will be well coordinated to results of calculations. The question on an opportunity of definition of weight of the measured blocks of fissile material is considered [ru

Multiple sclerosis

DEFF Research Database (Denmark)

Stenager, E; Jensen, K

1990-01-01

An investigation on the correlation between ability to read TV subtitles and the duration of visual evoked potential (VEP) latency in 14 patients with definite multiple sclerosis (MS), indicated that VEP latency in patients unable to read the TV subtitles was significantly delayed in comparison...

Definition of drug-resistant epilepsy: is it evidence based?

Science.gov (United States)

Wiebe, Samuel

2013-05-01

Clinical case definitions are the cornerstone of clinical communication and of clinical and epidemiologic research. The ramifications of establishing a case definition are extensive, including potentially large changes in epidemiologic estimates of frequency, and decisions for clinical management. Yet, defining a condition entails numerous challenges such as defining the scope and purpose, incorporating the strongest evidence base with clinical expertise, accounting for patients' values, and considering impact on care. The clinical case definition of drug-resistant epilepsy, in addition, must address what constitutes an adequate intervention for an individual drug, what are the outcomes of relevance, what period of observation is sufficient to determine success or failure, how many medications should be tried, whether seizure frequency should play a role, and what is the role of side effects and tolerability. On the other hand, the principles of evidence-based medicine (EBM) aim at providing a systematic approach to incorporating the best available evidence into the process of clinical decision for individual patients. The case definition of drug-resistant epilepsy proposed by the the International League Against Epilepsy (ILAE) in 2009 is evaluated in terms of the principles of EBM as well as the stated goals of the authors of the definition. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

Contesting Pornography: Terministic Catharsis and Definitional Argument.

Science.gov (United States)

Palczewski, Catherine Helen

2001-01-01

Focuses on the debates over the MacKinnon-Dworkin Anti-Pornography Ordinance to explore one instance of definitional argument: the attempt to effect a redefinition. Argues that advocates for a definitional shift created the possibility for a "terministic catharsis" by simultaneously locating pornography in multiple locations on the pentad,…

Case definition and classification of leukodystrophies and leukoencephalopathies

NARCIS (Netherlands)

Vanderver, Adeline; Prust, Morgan; Tonduti, Davide; Mochel, Fanny; Hussey, Heather M.; Helman, Guy; Garbern, James; Eichler, Florian; Labauge, Pierre; Aubourg, Patrick; Rodriguez, Diana; Patterson, Marc C.; van Hove, Johan L. K.; Schmidt, Johanna; Wolf, Nicole I.; Boespflug-Tanguy, Odile; Schiffmann, Raphael; van der Knaap, Marjo S.

2015-01-01

An approved definition of the term leukodystrophy does not currently exist. The lack of a precise case definition hampers efforts to study the epidemiology and the relevance of genetic white matter disorders to public health. Thirteen experts at multiple institutions participated in iterative

Case definition and classification of leukodystrophies and leukoencephalopathies

NARCIS (Netherlands)

Vanderver, A.; Prust, M.; Tonduti, D.; Mochel, F.; Hussey, H.M.; Helman, G.; Garbern, J.; Eichler, F.; Labauge, P.; Aubourg, P.; Rodriguez, D.; Patterson, M.C.; van Hove, J.LK.; Schmidt, J; Wolf, N.I.; Boespflug-Tanguy, O.; Schiffmann, R.; van der Knaap, M.S.

2015-01-01

Objective: An approved definition of the term leukodystrophy does not currently exist. The lack of a precise case definition hampers efforts to study the epidemiology and the relevance of genetic white matter disorders to public health. Method: Thirteen experts at multiple institutions participated

Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial

OpenAIRE

K???k, Fadime; Kara, Bilge; Poyraz, Esra ?o?kuner; ?diman, Egemen

2016-01-01

[Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression ...

Chronic Fatigue Syndrome – A clinically empirical approach to its definition and study

Directory of Open Access Journals (Sweden)

Papanicolaou Dimitris A

2005-12-01

Full Text Available Abstract Background The lack of standardized criteria for defining chronic fatigue syndrome (CFS has constrained research. The objective of this study was to apply the 1994 CFS criteria by standardized reproducible criteria. Methods This population-based case control study enrolled 227 adults identified from the population of Wichita with: (1 CFS (n = 58; (2 non-fatigued controls matched to CFS on sex, race, age and body mass index (n = 55; (3 persons with medically unexplained fatigue not CFS, which we term ISF (n = 59; (4 CFS accompanied by melancholic depression (n = 27; and (5 ISF plus melancholic depression (n = 28. Participants were admitted to a hospital for two days and underwent medical history and physical examination, the Diagnostic Interview Schedule, and laboratory testing to identify medical and psychiatric conditions exclusionary for CFS. Illness classification at the time of the clinical study utilized two algorithms: (1 the same criteria as in the surveillance study; (2 a standardized clinically empirical algorithm based on quantitative assessment of the major domains of CFS (impairment, fatigue, and accompanying symptoms. Results One hundred and sixty-four participants had no exclusionary conditions at the time of this study. Clinically empirical classification identified 43 subjects as CFS, 57 as ISF, and 64 as not ill. There was minimal association between the empirical classification and classification by the surveillance criteria. Subjects empirically classified as CFS had significantly worse impairment (evaluated by the SF-36, more severe fatigue (documented by the multidimensional fatigue inventory, more frequent and severe accompanying symptoms than those with ISF, who in turn had significantly worse scores than the not ill; this was not true for classification by the surveillance algorithm. Conclusion The empirical definition includes all aspects of CFS specified in the 1994 case definition and identifies persons with

Clinical consequences of the revised DSM-5 definition of agoraphobia in treatment-seeking anxious youth

Science.gov (United States)

Cornacchio, Danielle; Chou, Tommy; Sacks, Hayley; Pincus, Donna; Comer, Jonathan

2015-01-01

Background In DSM-5, the agoraphobia core symptom criterion has been revised to require fear about multiple situations from across at least two distinct domains in which escape might be difficult or panic-like symptoms might develop. The present study examined patterns and correlates of the recent change in a sample of anxious youth with symptom presentations consistent with the DSM-IV agoraphobia definition and/or specific phobia (SP) to consider how the recent diagnostic change impacts the prevalence and composition of agoraphobia in children and adolescents. Method Analyses (N=151) evaluated impairment and correlates of agoraphobic youth who no longer meet the DSM-5 agoraphobia criteria relative to agoraphobic youth who do meet the new DSM-5 criteria. Secondary analyses compared agoraphobic youth not meeting DSM-5 criteria to SP youth. Results One-quarter of youth with symptom presentations consistent with the DSM-IV agoraphobia definition no longer met criteria for DSM-5 agoraphobia, but showed comparable severity and impairment across most domains to youth who do meet criteria for DSM-5 agoraphobia. Further, these youth showed higher levels of anxiety sensitivity and internalizing psychopathology relative to youth with SP. Conclusions A substantial proportion of impaired youth with considerable agoraphobic symptom presentations have been left without a specified anxiety diagnosis by the DSM-5, which may affect their ability to receive and/or get coverage for services and their representation in treatment evaluations. Future DSM iterations may do well to include a “circumscribed” agoraphobia specifier that would characterize presentations of fear or anxiety about multiple situations, but that do not span across at least two distinct situational domains. PMID:25845579

Malignant multiple sclerosis: clinical and demographic prognostic factors

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Fabrício Hampshire-Araújo

Full Text Available ABSTRACT Patients with malignant multiple sclerosis (MMS reach a significant level of disability within a short period of time (Expanded Disability Status Scale score of 6 within five years. The clinical profile and progression of the disease were analyzed in a Brazilian cohort of 293 patients. Twenty-five (8,53% patients were found to have MMS and were compared with the remaining 268 (91,47%. Women, non-white patients, older age at disease onset, shorter intervals between the first attacks, and more attacks in the first two years of the disease were all more common in the MMS group. These findings could serve as prognostic factors when making therapeutic decisions.

A pragmatic definition of therapeutic synergy suitable for clinically relevant in vitro multicompound analyses.

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Kashif, Muhammad; Andersson, Claes; Åberg, Magnus; Nygren, Peter; Sjöblom, Tobias; Hammerling, Ulf; Larsson, Rolf; Gustafsson, Mats G

2014-07-01

For decades, the standard procedure when screening for candidate anticancer drug combinations has been to search for synergy, defined as any positive deviation from trivial cases like when the drugs are regarded as diluted versions of each other (Loewe additivity), independent actions (Bliss independence), or no interaction terms in a response surface model (no interaction). Here, we show that this kind of conventional synergy analysis may be completely misleading when the goal is to detect if there is a promising in vitro therapeutic window. Motivated by this result, and the fact that a drug combination offering a promising therapeutic window seldom is interesting if one of its constituent drugs can provide the same window alone, the largely overlooked concept of therapeutic synergy (TS) is reintroduced. In vitro TS is said to occur when the largest therapeutic window obtained by the best drug combination cannot be achieved by any single drug within the concentration range studied. Using this definition of TS, we introduce a procedure that enables its use in modern massively parallel experiments supported by a statistical omnibus test for TS designed to avoid the multiple testing problem. Finally, we suggest how one may perform TS analysis, via computational predictions of the reference cell responses, when only the target cell responses are available. In conclusion, the conventional error-prone search for promising drug combinations may be improved by replacing conventional (toxicology-rooted) synergy analysis with an analysis focused on (clinically motivated) TS. ©2014 American Association for Cancer Research.

Reliability of digital ulcer definitions as proposed by the UK Scleroderma Study Group: A challenge for clinical trial design.

Science.gov (United States)

Hughes, Michael; Tracey, Andrew; Bhushan, Monica; Chakravarty, Kuntal; Denton, Christopher P; Dubey, Shirish; Guiducci, Serena; Muir, Lindsay; Ong, Voon; Parker, Louise; Pauling, John D; Prabu, Athiveeraramapandian; Rogers, Christine; Roberts, Christopher; Herrick, Ariane L

2018-06-01

The reliability of clinician grading of systemic sclerosis-related digital ulcers has been reported to be poor to moderate at best, which has important implications for clinical trial design. The aim of this study was to examine the reliability of new proposed UK Scleroderma Study Group digital ulcer definitions among UK clinicians with an interest in systemic sclerosis. Raters graded (through a custom-built interface) 90 images (80 unique and 10 repeat) of a range of digital lesions collected from patients with systemic sclerosis. Lesions were graded on an ordinal scale of severity: 'no ulcer', 'healed ulcer' or 'digital ulcer'. A total of 23 clinicians - 18 rheumatologists, 3 dermatologists, 1 hand surgeon and 1 specialist rheumatology nurse - completed the study. A total of 2070 (1840 unique + 230 repeat) image gradings were obtained. For intra-rater reliability, across all images, the overall weighted kappa coefficient was high (0.71) and was moderate (0.55) when averaged across individual raters. Overall inter-rater reliability was poor (0.15). Although our proposed digital ulcer definitions had high intra-rater reliability, the overall inter-rater reliability was poor. Our study highlights the challenges of digital ulcer assessment by clinicians with an interest in systemic sclerosis and provides a number of useful insights for future clinical trial design. Further research is warranted to improve the reliability of digital ulcer definition/rating as an outcome measure in clinical trials, including examining the role for objective measurement techniques, and the development of digital ulcer patient-reported outcome measures.

Rehabilitation and multiple limb amputations: A clinical report of patients injured in combat.

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Melcer, Ted; Pyo, Jay; Walker, Jay; Quinn, Kimberly; Lebedda, Martin; Neises, Kamaran; Nguyen, Christina; Galarneau, Michael

2016-01-01

This clinical report describes the outpatient rehabilitation program for patients with multiple limb amputations enrolled in the Comprehensive Combat and Complex Casualty Care facility at the Naval Medical Center San Diego. Injury-specific data for 29 of these patients wounded by blast weaponry in Afghanistan in 2010 or 2011 were captured by the Expeditionary Medical Encounter Database at the Naval Health Research Center and were reviewed for this report. Their median Injury Severity Score was 27 (N = 29; range, 11-54). Patients averaged seven moderate to serious injuries (Abbreviated Injury Scale scores ≥2), including multiple injuries to lower limbs and injuries to the torso and/or upper limbs. All patients received care from numerous clinics, particularly physical therapy during the first 6 mo postinjury. Clinic use generally declined after the first 6 mo with the exception of prosthetic devices and repairs. The clinical team implemented the Mayo-Portland Adaptability Inventory, 4th Revision (MPAI-4) to assess functioning at outpatient program initiation and discharge (n = 23). At program discharge, most patients had improved scores for the MPAI-4 items assessing mobility, pain, and transportation, but not employment. Case reports described rehabilitation for two patients with triple amputations and illustrated multispecialty care and contrasting solutions for limb prostheses.

Definition and measurement of guilt: Implications for clinical research and practice

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Tilghman-Osborne, Carlos; Cole, David A.; Felton, Julia W.

2014-01-01

Research on the relation of guilt to psychopathology is highly inconsistent. Some studies suggest that guilt contributes to psychopathology; others suggest that guilt serves a protective role. This review of 23 theory-based definitions of guilt and 25 measures of guilt suggests that a lack of conceptual clarity may be to blame. Measures of guilt do not correspond well to the definitions from which they derive. Many definitions and measures reflect the intrusion of extraneous constructs that could confound guilt research. Furthermore, definitions and measures of guilt change with developmental level. Nevertheless, two broad conceptualizations of guilt emerge. Central to both is a focus on one’s action or inactions involving real or imagined moral transgressions. Distinguishing the two conceptualizations is whether or not guilt is inherently adaptive construct, generating remorse, augmenting a sense of responsibility, and motivating reparation. Recommendations for the definition and measurement of guilt are discussed. PMID:20451312

Feasibility of mesenchymal stem cell culture expansion for a phase I clinical trial in multiple sclerosis.

Science.gov (United States)

Planchon, Sarah M; Lingas, Karen T; Reese Koç, Jane; Hooper, Brittney M; Maitra, Basabi; Fox, Robert M; Imrey, Peter B; Drake, Kylie M; Aldred, Micheala A; Lazarus, Hillard M; Cohen, Jeffrey A

2018-01-01

Multiple sclerosis is an inflammatory, neurodegenerative disease of the central nervous system for which therapeutic mesenchymal stem cell transplantation is under study. Published experience of culture-expanding multiple sclerosis patients' mesenchymal stem cells for clinical trials is limited. To determine the feasibility of culture-expanding multiple sclerosis patients' mesenchymal stem cells for clinical use. In a phase I trial, autologous, bone marrow-derived mesenchymal stem cells were isolated from 25 trial participants with multiple sclerosis and eight matched controls, and culture-expanded to a target single dose of 1-2 × 10 6 cells/kg. Viability, cell product identity and sterility were assessed prior to infusion. Cytogenetic stability was assessed by single nucleotide polymorphism analysis of mesenchymal stem cells from 18 multiple sclerosis patients and five controls. One patient failed screening. Mesenchymal stem cell culture expansion was successful for 24 of 25 multiple sclerosis patients and six of eight controls. The target dose was achieved in 16-62 days, requiring two to three cell passages. Growth rate and culture success did not correlate with demographic or multiple sclerosis disease characteristics. Cytogenetic studies identified changes on one chromosome of one control (4.3%) after extended time in culture. Culture expansion of mesenchymal stem cells from multiple sclerosis patients as donors is feasible. However, culture time should be minimized for cell products designated for therapeutic administration.

Universal MI definition update for cardiovascular disease.

Science.gov (United States)

White, Harvey; Thygesen, Kristian; Alpert, Joseph S; Jaffe, Allan

2014-01-01

The new third universal definition of myocardial infarction (MI) is based on troponin elevation together with ischemic symptoms, ischemic ECG changes, and imaging evidence. MIs are classified into five types as to whether they are spontaneous, secondary to imbalance between coronary artery blood supply and demand, related to sudden death, or related to revascularization procedures. The definition is based on a rise and/or fall in troponin levels occurring in a clinical setting. There have been modifications over previous definitions with adding intracoronary thrombus as a criterion, adding a new type of MI type 4c, and raising the cutpoint for the diagnosis of MI related to percutaneous coronary intervention to five times the 99(th) percentile upper reference limit and requiring evidence of ischemia or angiographic complications. In clinical practice, trials, and registries, different definitions are used. There is a need for consistency with regard to the definition of MI and the universal definition should be implemented.

Clinical features of multiple spontaneous intracerebral hemorrhages

Directory of Open Access Journals (Sweden)

Tao CHANG

2016-01-01

Full Text Available Objective To analyze the clinical features of multiple spontaneous intracerebral hemorrhages (MICH. Methods Conservative therapy, puncture and drainage, hematoma removal and/or decompressive craniectomy were used in the treatment of 630 intracerebral hemorrhage (ICH patients, who were divided into 2 groups: 30 cases with MICH and another 600 cases with solitary intracerebral hemorrhage (SICH. Three months after onset, modified Rankin Scale (mRS was used to evaluate the prognosis of all cases. Results Compared with patients in SICH group, the occurrence rate of hypertension > 5 years (P = 0.008, diabetes mellitus (P = 0.024, hypercholesterolemia (P = 0.050 and previous ischemic stroke (P = 0.026 were all significantly higher in MICH group. The mean arterial pressure (MAP level (P = 0.002 and the incidence of limb movement disorder (P = 0.000 were significantly higher in patients with MICH than those with SICH. Basal ganglia and thalamus were the predilection sites of hematoma (P = 0.001. Patients with MICH had worse prognosis compared to those with SICH 3 months after onset (P = 0.006. Conclusions Hypertension > 5 years, diabetes mellitus, hypercholesterolemia and ischemic stroke were identified to be the pathophysiological basis of MICH in this study. All patients with MICH had more serious clinical manifestations after onset and worse prognosis. DOI: 10.3969/j.issn.1672-6731.2016.01.008

Multiple sclerosis

DEFF Research Database (Denmark)

Stenager, E; Knudsen, L; Jensen, K

1994-01-01

In a cross-sectional study of 94 patients (42 males, 52 females) with definite multiple sclerosis (MS) in the age range 25-55 years, the correlation of neuropsychological tests with the ability to read TV-subtitles and with the use of sedatives is examined. A logistic regression analysis reveals...

Patients with multiple contact allergies

DEFF Research Database (Denmark)

Carlsen, Berit Christina; Andersen, Klaus Ejner; Menné, Torkil

2008-01-01

Patients with multiple contact allergies, also referred to as polysensitized, are more frequent than predicted from prevalence of single sensitivities. The understanding of why some people develop multiple contact allergies, and characterization of patients with multiple contact allergies...... of developing multiple contact allergies. Evidence of allergen clusters among polysensitized individuals is also reviewed. The literature supports the idea that patients with multiple contact allergies constitute a special entity within the field of contact allergy. There is no generally accepted definition...... of patients with multiple contact allergies. We suggest that contact allergy to 3 or more allergens are defined as multiple contact allergies....

Prevalence, demographics and clinical characteristics of multiple sclerosis in Qatar.

Science.gov (United States)

Deleu, Dirk; Mir, Danial; Al Tabouki, Ahmed; Mesraoua, Rim; Mesraoua, Boulenouar; Akhtar, Naveed; Al Hail, Hassan; D'souza, Atlantic; Melikyan, Gayane; Imam, Yahia Z B; Osman, Yasir; Elalamy, Osama; Sokrab, Tageldin; Kamran, Sadaat; Ruiz Miyares, Francisco; Ibrahim, Faiza

2013-05-01

No published epidemiologic data on multiple sclerosis (MS) in Qatar exist. Our objectives were to determine the prevalence, demographics and clinical characteristics of MS in the Middle Eastern country of Qatar. We analyzed data for Qatari MS patients fulfilling the McDonald diagnostic criteria. A total of 154 patients fulfilled the inclusion criteria. On 31 April 2010, the crude prevalence of MS in Qatar was 64.57 per 100,000 inhabitants (95% CI: 58.31-70.37). The female-to-male ratio was 1.33:1. A positive family history was found in 10.4% of included MS patients. We conclude that Qatar is now a medium-to-high risk area for MS, with some important differences in clinical characteristics as compared to other countries in the region.

CLIPPERS-like MRI findings in a patient with multiple sclerosis.

Science.gov (United States)

Ferreira, R M; Machado, G; Souza, A S; Lin, K; Corrêa-Neto, Y

2013-04-15

Chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS) has been described as a clinically and radiologically distinct pontine-predominant encephalomyelitis with a favorable response to high dose corticosteroids and usually requiring chronic immunosuppresive therapy. Brain magnetic resonance imaging (MRI) reveals a characteristic pattern of punctate and curvilinear enhancement lesions in the pons extending variably to surrounding areas. We herein describe such imaging findings in a patient with a definite diagnosis of relapsing-remitting multiple sclerosis (MS). Copyright © 2013 Elsevier B.V. All rights reserved.

Nitric oxide synthase expression and enzymatic activity in multiple sclerosis

DEFF Research Database (Denmark)

Broholm, H; Andersen, B; Wanscher, B

2004-01-01

We used post-mortem magnetic resonance imaging (MRI) guidance to obtain paired biopsies from the brains of four patients with clinical definite multiple sclerosis (MS). Samples were analyzed for the immunoreactivity (IR) of the three nitric oxide (NO) synthase isoforms [inducible, neuronal......NOS expressing cells in active lesions. NOS IR expressing cells were widely distributed in plaques, in white and gray matter that appeared normal macroscopically, and on MR. Endothelial NOS (eNOS) was highly expressed in intraparenchymal vascular endothelial cells of MS patients. A control group matched for age...

Acute gouty arthritis and rapidly progressive renal failure as manifestation of multiple myeloma: clinical case description

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O.V. Gudym

2017-08-01

Full Text Available The article describes a clinical case of multiple myeloma in 78-year-old man, its clinical onset was as an acute attack of gout. The patient was admitted to hospital due to the development of the first acute attack of gout. The attack was characterized by polyarthricular joint lesion of the upper and lower extremities, pronounced inflammatory reaction, insufficient response to the use of non-steroidal anti-inflammatory drugs, and a high level of hyperuricemia. The serum uric acid concentration ranged from 636 to 712 μmol/l. The study of the synovial fluid of the inflamed knee joint made it possible to reveal uric acid crystals and to confirm the diagnosis of acute gouty arthritis. Simultaneously, the patient had significant renal impairment: creatinine was 574 μmol/l, urea — 39.9 mmol/l, glomerular filtration rate according to CKD-EPI — 8 ml/min. The daily proteinuria was 1.8 g. A retrospective assessment of laboratory parameters allowed to reveal completely normal indicators of renal function 6 months ago. Considering the development of acute gouty arthritis, its polyarticular nature, persistent course, rapid involvement of new joints, high uric acid levels during an acute attack exceeding 600 μmol/l (10 mg/dL, rapid development of renal failure within 6 months until the terminal stage, it was suggested the secondary nature of gout on the background of kidney damage by another pathological process. Further clinical, laboratory and instrumental studies allowed verifying multiple myeloma with renal damage. Bence Jones protein in the urine was not detected, there was also no evidence of hyperproteinemia. However, pain in the spine, ribs and chest was the basis for carrying out an X-ray study of the bones of the skeleton. Changes in the skeleton typical for multiple myeloma have been identified. Myelogram showed a high content of plasma cells (21.1 %, electrophoresis of blood proteins showed a high M-gradient (30.42 %, and a cytochemical

Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial.

Science.gov (United States)

Warke, Kim; Al-Smadi, Jamal; Baxter, David; Walsh, Deirdre M; Lowe-Strong, Andrea S

2006-01-01

This study was designed to investigate the hypoalgesic effects of self-applied transcutaneous electrical nerve stimulation (TENS) on chronic low-back pain (LBP) in a multiple sclerosis (MS) population. Ninety participants with probable or definite MS (aged 21 to 78 y) presenting with chronic LBP were recruited and randomized into 3 groups (n=30 per group): (1) low-frequency TENS group (4 Hz, 200 micros); (2) high-frequency TENS group (110 Hz, 200 micros); and (3) placebo TENS. Participants self-applied TENS for 45 minutes, a minimum of twice daily, for 6 weeks. Outcome measures were recorded at weeks 1, 6, 10, and 32. Primary outcome measures included: Visual Analog Scale for average LBP and the McGill Pain Questionnaire. Secondary outcome measures included: Visual Analog Scale for worst and weekly LBP, back and leg spasm; Roland Morris Disability Questionnaire; Barthel Index; Rivermead Mobility Index; Multiple Sclerosis Quality of Life-54 Instrument, and a daily logbook. Data were analyzed blind using parametric and nonparametric tests, as appropriate. Results indicated a statistically significant interactive effect between groups for average LBP (P=0.008); 1-way analysis of covariance did not show any significant effects at any time point once a Bonferonni correction was applied (P>0.05). However, clinically important differences were observed in some of the outcome measures in both active treatment groups during the treatment and follow-up periods. Although not statistically significant, the observed effects may have implications for the clinical prescription and the use of TENS within this population.

Accuracy of Zika virus disease case definition during simultaneous Dengue and Chikungunya epidemics.

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José Ueleres Braga

Full Text Available Zika is a new disease in the American continent and its surveillance is of utmost importance, especially because of its ability to cause neurological manifestations as Guillain-Barré syndrome and serious congenital malformations through vertical transmission. The detection of suspected cases by the surveillance system depends on the case definition adopted. As the laboratory diagnosis of Zika infection still relies on the use of expensive and complex molecular techniques with low sensitivity due to a narrow window of detection, most suspected cases are not confirmed by laboratory tests, mainly reserved for pregnant women and newborns. In this context, an accurate definition of a suspected Zika case is crucial in order for the surveillance system to gauge the magnitude of an epidemic.We evaluated the accuracy of various Zika case definitions in a scenario where Dengue and Chikungunya viruses co-circulate. Signs and symptoms that best discriminated PCR confirmed Zika from other laboratory confirmed febrile or exanthematic diseases were identified to propose and test predictive models for Zika infection based on these clinical features.Our derived score prediction model had the best performance because it demonstrated the highest sensitivity and specificity, 86·6% and 78·3%, respectively. This Zika case definition also had the highest values for auROC (0·903 and R2 (0·417, and the lowest Brier score 0·096.In areas where multiple arboviruses circulate, the presence of rash with pruritus or conjunctival hyperemia, without any other general clinical manifestations such as fever, petechia or anorexia is the best Zika case definition.

Reviewing the definition of crisis in dementia care

NARCIS (Netherlands)

MacNeil-Vroomen, J.L.; Bosmans, J.E.; van Hout, H.P.J.; de Rooij, S.E.

2013-01-01

Background: Crisis is a term frequently used in dementia care lacking a standardized definition. This article systematically reviews existing definitions of crisis in dementia care literature to create a standardized definition that can be utilized for research, policy and clinical practice.

Clinical Definitions of Sarcopenia and Risk of Hospitalization in Community-Dwelling Older Men: The Osteoporotic Fractures in Men Study.

Science.gov (United States)

Cawthon, Peggy M; Lui, Li-Yung; Taylor, Brent C; McCulloch, Charles E; Cauley, Jane A; Lapidus, Jodi; Orwoll, Eric; Ensrud, Kristine E

2017-10-01

The association between various definitions of sarcopenia and hospitalization has not been evaluated in community-dwelling older men. We used data from 1,516 participants at Visit 3 of the Osteoporotic Fractures in Men (MrOS) study who also had linked Medicare Fee-For-Service Claims data available. We examined the association between several sarcopenia definitions (International Working Group, European Working Group for Sarcopenia in Older Persons, Foundation for the NIH Sarcopenia Project, Baumgartner, and Newman) and hospitalization, using two-part ("hurdle") models, adjusted for age, clinical center, functional limitations, self-reported health, comorbidity, and cognitive function. Predictors included sarcopenia status (the summary definitions and the components of slowness, weakness, and/or lean mass); outcomes included hospitalization and cumulative inpatient days/year in the 3 years following the Visit 3 exam. After accounting for confounding factors, none of the summary definitions or the definition components (slowness, weakness, or low lean mass) were associated with likelihood of hospitalization, the rate ratio of inpatient days among those hospitalized, or the mean rate of inpatient days amongst all participants. Sarcopenia was not associated hospitalization in community-dwelling older men. These results provide further evidence that current sarcopenia definitions are unlikely to identify those who are most likely to have greater hospitalization. © The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

48 CFR 247.301-70 - Definition.

Science.gov (United States)

2010-10-01

... Definition. “Integrated logistics managers” or “third-party logistics providers” means providers of multiple logistics services. Some examples of logistics services are the management of transportation, demand...

Definitions of Exacerbations Does It Really Matter in Clinical Trials on COPD?

NARCIS (Netherlands)

Effing, Tanja W.; Kerstjens, Huib A. M.; Monninkhof, Evelyn M.; van der Valk, Paul D. L. P. M.; Wouters, Emiel F. M.; Postma, Dirkje S.; Zielhuis, Gerhard A.; van der Palen, Job

Many definitions of COPD exacerbations are reported. The choice for a definition determines the number of exacerbations observed. However, the effect of different definitions on the effect sizes of randomized controlled trials is unclear. This article provides an overview of the large variation of

Definitions of exacerbations: does it really matter in clinical trials on COPD?

NARCIS (Netherlands)

Effing-Tijdhof, T.W.; Kerstjens, H.A.; Monninkhof, E.M.; Valk, P.D.L.P.M. van der; Wouters, E.F.; Postma, D.S.; Zielhuis, G.A.; Palen, J.A.M. van der

2009-01-01

Many definitions of COPD exacerbations are reported. The choice for a definition determines the number of exacerbations observed. However, the effect of different definitions on the effect sizes of randomized controlled trials is unclear. This article provides an overview of the large variation of

Quality of Care for Patients with Multiple Chronic Conditions: The Role of Comorbidity Interrelatedness

OpenAIRE

Zulman, Donna M.; Asch, Steven M.; Martins, Susana B.; Kerr, Eve A.; Hoffman, Brian B.; Goldstein, Mary K.

2013-01-01

Multimorbidity—the presence of multiple chronic conditions in a patient—has a profound impact on health, health care utilization, and associated costs. Definitions of multimorbidity in clinical care and research have evolved over time, initially focusing on a patient’s number of comorbidities and the associated magnitude of required care processes, and later recognizing the potential influence of comorbidity characteristics on patient care and outcomes. In this article, we review the relation...

ASPEN-AND-ESPEN: A postacute-care comparison of the basic definition of malnutrition from the American Society of Parenteral and Enteral Nutrition and Academy of Nutrition and Dietetics with the European Society for Clinical Nutrition and Metabolism definition.

Science.gov (United States)

Sánchez-Rodríguez, Dolores; Marco, Ester; Ronquillo-Moreno, Natalia; Maciel-Bravo, Liev; Gonzales-Carhuancho, Abel; Duran, Xavier; Guillén-Solà, Anna; Vázquez-Ibar, Olga; Escalada, Ferran; Muniesa, Josep M

2018-01-25

The aim of this study was to assess the prevalence of malnutrition by applying the ASPEN/AND definition and the ESPEN consensus definition in a postacute-care population, and secondly, to determine the metrological properties of the set of six clinical characteristics that constitute the ASPEN/AND basic diagnosis, compared to the ESPEN consensus, based mostly on objective anthropometric measurements. Prospective study of 84 consecutive deconditioned older inpatients (85.4 ± 6.2; 59.5% women) admitted for rehabilitation in postacute care. ASPEN/AND diagnosis of malnutrition was considered in presence of at least two of the following: low energy intake, fluid accumulation, diminished handgrip strength, and loss of weight, muscle mass, or subcutaneous fat. Sensitivity, specificity, positive and negative predictive values, accuracy, likelihood ratios, and kappa statistics were calculated for ASPEN/AND criteria and compared with ESPEN consensus. The prevalence of malnutrition by ASPEN/AND criteria was 63.1% and by ESPEN consensus, 20.2%; both diagnoses were associated with significantly longer length of stay, but the ESPEN definition was significantly associated with poorer functional outcomes after the rehabilitation program. Compared to ESPEN consensus, ASPEN/AND diagnosis showed fair validity (sensitivity = 94.1%; specificity = 44.8%); kappa statistic was 2.217. Applying the ASPEN/AND definition obtained a higher prevalence of malnutrition in a postacute-care population than was identified by the ESPEN definition. ASPEN/AND criteria had fair validity and agreement compared with the ESPEN definition. A simple, evidence-based, unified malnutrition definition might improve geriatric care. Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Suppressive effect of glucocorticoids on TNF-alpha production is associated with their clinical effect in multiple sclerosis

NARCIS (Netherlands)

van Winsen, L.M.L.; Polman, C.H.; Dijkstra, C.D.; Tilders, F.J.H.; Uitdehaag, B.M.J.

2010-01-01

A reduced sensitivity to glucocorticoids can affect the clinical effect of treatment with high-dose intravenous methylprednisolone in multiple sclerosis. We prospectively studied 27 multiple sclerosis patients who were treated with intravenous methylprednisolone. Before and after treatment in vitro

Reviewing the definition of crisis in dementia care

NARCIS (Netherlands)

Vroomen, Janet MacNeil; Bosmans, Judith E.; van Hout, Hein P. J.; de Rooij, Sophia E.

2013-01-01

Crisis is a term frequently used in dementia care lacking a standardized definition. This article systematically reviews existing definitions of crisis in dementia care literature to create a standardized definition that can be utilized for research, policy and clinical practice. We systematically

Multiple sclerosis

DEFF Research Database (Denmark)

Stenager, Egon; Stenager, E N; Knudsen, Lone

1994-01-01

In a cross-sectional study of 117 randomly selected patients (52 men, 65 women) with definite multiple sclerosis, it was found that 76 percent were married or cohabitant, 8 percent divorced. Social contacts remained unchanged for 70 percent, but outgoing social contacts were reduced for 45 percent......, need for structural changes in home and need for pension became greater with increasing physical handicap. No significant differences between gender were found. It is concluded that patients and relatives are under increased social strain, when multiple sclerosis progresses to a moderate handicap...

A Hierarchical Multiple-Level Approach to the Assessment of Interpersonal Relatedness and Self-Definition: Implications for Research, Clinical Practice, and DSM Planning.

Science.gov (United States)

Luyten, Patrick; Blatt, Sidney J

2016-01-01

Extant research suggests there is considerable overlap between so-called 2-polarities models of personality development; that is, models that propose that personality development evolves through a dialectic synergistic interaction between 2 key developmental tasks across the life span-the development of self-definition on the one hand and of relatedness on the other. These models have attracted considerable research attention and play a central role in DSM planning. This article provides a researcher- and clinician-friendly guide to the assessment of these personality theories. We argue that current theoretical models focus on issues of relatedness and self-definition at different hierarchically organized levels of analysis; that is (a) at the level of broad personality features, (b) at the motivational level (i.e., the motivational processes underlying the development of these dimensions), and (c) at the level of underlying internal working models or cognitive affective schemas, and the specific interpersonal features and problems in which they are expressed. Implications for further research and DSM planning are outlined.

Refining the definition of mandibular osteoradionecrosis in clinical trials: The cancer research UK HOPON trial (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis).

Science.gov (United States)

Shaw, Richard; Tesfaye, Binyam; Bickerstaff, Matt; Silcocks, Paul; Butterworth, Christopher

2017-01-01

Mandibular osteoradionecrosis (ORN) is a common and serious complication of head and neck radiotherapy for which there is little reliable evidence for prevention or treatment. The diagnosis and classification of ORN have been inconsistently and imprecisely defined, even in clinical trials. A systematic review of diagnosis and classifications of ORN with specific focus on clinical trials is presented. The most suitable classification was evaluated for consistency using blinded independent review of outcome data (clinical photographs and radiographs) in the HOPON trial. Of 16 ORN classifications found, only one (Notani) appeared suitable as an endpoint in clinical trials. Clinical records of 217 timepoints were analysed amongst 94 randomised patients in the HOPON trial. The only inconsistency in classification arose where minor bone spicules (MBS) were apparent, which occurred in 19% of patients. Some trial investigators judged MBS as clinically unimportant and not reflecting ORN, others classified as ORN based on rigid definitions in common clinical use. When MBS was added as a distinct category to the Notani classification this ambiguity was resolved and agreement between observers was achieved. Most definitions and clinical classifications are based on retrospective case series and may be unsuitable for prospective interventional trials of ORN prevention or treatment. When ORN is used as a primary or secondary outcome in prospective clinical trials, the use of Notani classification with the additional category of MBS is recommended as it avoids subjectivity and enhances reliability and consistency of reporting. Copyright © 2016 Elsevier Ltd. All rights reserved.

The definition and diagnosis of cold hypersensitivity in the hands and feet: Finding from the experts survey.

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Bae, Kwang-Ho; Jeong, Young-Seok; Go, Ho-Yeon; Sun, Seung-Ho; Kim, Tae-Hoon; Jung, Ki-Yong; Song, Yun-Kyung; Ko, Seong-Gyu; Choi, You-Kyung; Park, Jong-Hyeong; Lee, Siwoo; Lee, Youngseop; Jeon, Chan-Yong

2018-03-01

Cold hypersensitivity in the hands and feet (CHHF) is a symptom patients usually feel cold in their hands and feet, but not dealt with a disease in western medicine. However, it is often appealed by patients at a clinic of Korean medicine (KM), considered to be a sort of key diagnostic indicator, and actively treated by physicians. Nevertheless, there is no standardized diagnostic definition for CHHF. Therefore, we surveyed KM experts' opinions to address the clinical definition, diagnostic criteria, and other relevant things on CHHF. We developed a survey to assess the definition, diagnosis, causes, and accompanying symptoms on CHHF. 31 experts who work at specialized university hospitals affiliated with KM hospitals consented to participation. Experts responded to survey questions by selecting multiple-choice answers or stating their opinions. Vast majority of experts (83.8%) agreed with our definition on CHHF ("a feeling of cold as a symptom; that one's hands or feet become colder than those of average people in temperatures that are not normally perceived as cold"). 77.4% of experts considered subjective symptoms on CHHF were more important than medical instrument results. Constitution or genetic factors (87.1%) and stress (64.5%) were the most common causes reported for CHHF. This study offers an expert consensus regarding the themes, opinions, and experiences of practitioners with CHHF. Our results underscore the need for standardized definitions and diagnostic criteria for CHHF.

Managing serious clinical deterioration in a tertiary hospital in Hong Kong: from indicators development to multiple measures in reducing the rates.

Science.gov (United States)

Ho, Jasperine Ka Yee; Lee, Quinnie; Lam, Jaden Chun Ho; Tang, Kam Shing

2017-06-01

Timely detection and management of acutely deteriorating patients can save lives. Tuen Mun Hospital (TMH), a 1800-bed acute tertiary hospital serving more than 1.06 million populations in Hong Kong, is exploring to quantitatively monitor serious clinical deterioration (SCD) and uses it to guide patient care improvement initiatives. Literature review on definition and measurement of SCD was conducted. Monthly SCD rates of TMH were first calculated according to the published methodology and benchmarked against those of international centres. A refined composite clinical indicator good for local use was compiled. In the second phase, p-control charts of SCD have been plotted based on cumulative data. TMH's performance was comparable with that of international centres. SCD on p-control charts has been plotting since January 2013. There were peaks in all 4 SCD rates during the winter surge period in 2013-2014. In the third phase, multiple measures have been taking to reduce the SCD rates including targeting the 3 main factors of winter surge situation. We are delighted to observe that the pattern did not repeat in the rate of cardiac arrest without do not attempt cardiopulmonary resuscitation (DNACPR) and rate of death without DNACPR in the same period in 2014-2015. SCD becomes a clinical governance tool to monitor the performance of clinical teams in treating acutely deteriorating patients in TMH. Any abnormal patterns or indications of special cause variations in the control charts would alert leaders to look for root causes of special cause variations and manage accordingly. We hope that this project will extend to corporate level and become a sustainable clinical indicator to guide audits, quality improvement initiatives and strategic planning. © 2016 John Wiley & Sons, Ltd.

Clinical relevance of hemoglobin level in cervical cancer patients administered definitive radiotherapy

International Nuclear Information System (INIS)

Serkies, Krystyna; Badzio, Andrzej; Jassem, Jacek

2006-01-01

The prognostic impact of pretreatment hemoglobin (Hb) level and its changes during definitive radiotherapy was evaluated by univariate and multivariate analysis in the group of 453 FIGO IB-IIIB cervical cancer patients. Pretreatment anemia (Hb 12 g/dl; p∼0.001). Baseline Hb =12 g/dl was also associated with longer disease-free survival and improved local control. Declining Hb level during radiotherapy predicted for impaired 5-year disease-free survival and local control probability. In multivariate analysis, low pretreatment Hb level remained associated with worse overall and disease-free survival, whereas adverse impact of declining Hb level on outcome was not observed. With regard to other clinical factors, stage and tumor extension (uni- or bilateral parametrium involvement for Stage III) were the only independent determinants of prognosis

Chaos theory for clinical manifestations in multiple sclerosis.

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Akaishi, Tetsuya; Takahashi, Toshiyuki; Nakashima, Ichiro

2018-06-01

Multiple sclerosis (MS) is a demyelinating disease which characteristically shows repeated relapses and remissions irregularly in the central nervous system. At present, the pathological mechanism of MS is unknown and we do not have any theories or mathematical models to explain its disseminated patterns in time and space. In this paper, we present a new theoretical model from a viewpoint of complex system with chaos model to reproduce and explain the non-linear clinical and pathological manifestations in MS. First, we adopted a discrete logistic equation with non-linear dynamics to prepare a scalar quantity for the strength of pathogenic factor at a specific location of the central nervous system at a specific time to reflect the negative feedback in immunity. Then, we set distinct minimum thresholds in the above-mentioned scalar quantity for demyelination possibly causing clinical relapses and for cerebral atrophy. With this simple model, we could theoretically reproduce all the subtypes of relapsing-remitting MS, primary progressive MS, and secondary progressive MS. With the sensitivity to initial conditions and sensitivity to minute change in parameters of the chaos theory, we could also reproduce the spatial dissemination. Such chaotic behavior could be reproduced with other similar upward-convex functions with appropriate set of initial conditions and parameters. In conclusion, by applying chaos theory to the three-dimensional scalar field of the central nervous system, we can reproduce the non-linear outcome of the clinical course and explain the unsolved disseminations in time and space of the MS patients. Copyright © 2018 Elsevier Ltd. All rights reserved.

Automatic segmentation of male pelvic anatomy on computed tomography images: a comparison with multiple observers in the context of a multicentre clinical trial

International Nuclear Information System (INIS)

Geraghty, John P; Grogan, Garry; Ebert, Martin A

2013-01-01

This study investigates the variation in segmentation of several pelvic anatomical structures on computed tomography (CT) between multiple observers and a commercial automatic segmentation method, in the context of quality assurance and evaluation during a multicentre clinical trial. CT scans of two prostate cancer patients (‘benchmarking cases’), one high risk (HR) and one intermediate risk (IR), were sent to multiple radiotherapy centres for segmentation of prostate, rectum and bladder structures according to the TROG 03.04 “RADAR” trial protocol definitions. The same structures were automatically segmented using iPlan software for the same two patients, allowing structures defined by automatic segmentation to be quantitatively compared with those defined by multiple observers. A sample of twenty trial patient datasets were also used to automatically generate anatomical structures for quantitative comparison with structures defined by individual observers for the same datasets. There was considerable agreement amongst all observers and automatic segmentation of the benchmarking cases for bladder (mean spatial variations < 0.4 cm across the majority of image slices). Although there was some variation in interpretation of the superior-inferior (cranio-caudal) extent of rectum, human-observer contours were typically within a mean 0.6 cm of automatically-defined contours. Prostate structures were more consistent for the HR case than the IR case with all human observers segmenting a prostate with considerably more volume (mean +113.3%) than that automatically segmented. Similar results were seen across the twenty sample datasets, with disagreement between iPlan and observers dominant at the prostatic apex and superior part of the rectum, which is consistent with observations made during quality assurance reviews during the trial. This study has demonstrated quantitative analysis for comparison of multi-observer segmentation studies. For automatic segmentation

22 CFR 1103.103 - Definitions.

Science.gov (United States)

2010-04-01

... Relations INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, UNITED STATES SECTION... BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, UNITED STATES SECTION § 1103.103 Definitions. For..., epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, diabetes, mental retardation...

Considerations concerning the definition of sarcopenia

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In this commentary, we describe the sarcopenia spectrum that results in frailty and consider the impact of several components of the frailty definition on its global prevalence. We review proposed operational definitions of sarcopenia the extent to which they have been shown to predict hard clinical...

Multiple large solar lentigos on the upper back as clinical markers of past severe sunburn: a case-control study.

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Derancourt, C; Bourdon-Lanoy, E; Grob, J-J; Guillaume, J-C; Bernard, P; Bastuji-Garin, S

2007-01-01

Multiple solar lentigos commonly seen on the upper back and shoulders of adults are classically considered as a sign of photodamage, although epidemiological studies are scarce. To assess whether these lesions are clinical markers of past severe sunburn. A case-control study in two outpatient dermatology clinics in French university hospitals. Past episodes of moderate and severe sunburn were compared between 145 adult patients with multiple solar lentigos on the upper back and 145 matched controls. In multivariate analysis adjusted for potential confounders, recalled episodes of sunburn during childhood, adolescence and adulthood were independently associated with the presence of multiple solar lentigos (adjusted odds ratios, 95% confidence intervals: 2.3 (1.1-5.2) and 28.1 (10.4-75.6) for moderate and severe sunburn, respectively). Multiple solar lentigos on the upper back and shoulders of adults are potential clinical markers of past severe sunburn which may thus be used to identify a population at higher risk of developing cutaneous malignant melanoma.

Preliminary definition of improvement in juvenile arthritis.

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Giannini, E H; Ruperto, N; Ravelli, A; Lovell, D J; Felson, D T; Martini, A

1997-07-01

To identify a core set of outcome variables for the assessment of children with juvenile arthritis (JA), to use the core set to develop a definition of improvement to determine whether individual patients demonstrate clinically important improvement, and to promote this definition as a single efficacy measure in JA clinical trials. A core set of outcome variables was established using a combination of statistical and consensus formation techniques. Variables in the core set consisted of 1) physician global assessment of disease activity; 2) parent/patient assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) erythrocyte sedimentation rate. To establish a definition of improvement using this core set, 21 pediatric rheumatologists from 14 countries met, and, using consensus formation techniques, scored each of 72 patient profiles as improved or not improved. Using the physicians' consensus as the gold standard, the chi-square, sensitivity, and specificity were calculated for each of 240 possible definitions of improvement. Definitions with sensitivity or specificity of definitions to discriminate between the effects of active agent and those of placebo, using actual trial data, was then observed. Each definition was also ranked for face validity, and the sum of the ranks was then multiplied by the kappa statistic. The definition of improvement with the highest final score was as follows: at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by >30%. The second highest scoring definition was closely related to the first; the third highest was similar to the Paulus criteria used in adult rheumatoid arthritis trials, except with different variables. This indicates convergent validity of the process used. We propose a definition of improvement for JA. Use of a uniform definition will help

Acute kidney injury: definition, diagnosis and epidemiology.

Science.gov (United States)

Rossaint, Jan; Zarbock, Alexander

2016-02-01

Acute kidney injury (AKI) is a common complication in hospitalized patients and great efforts by leading experts have been made in order to establish common definitions of AKI. The clinical use of these consensus definitions has led to a substantially improved understanding of AKI. In addition, the consensus definitions allow to compare AKI incidence and outcomes between different patient populations. As a result, it has become evident that AKI in the Western population represents a clinical syndrome with an incidence close to that of myocardial infarction. The aim of this review is to revisit the current concepts and definitions of AKI, to highlight its diagnosis, and to emphasize its epidemiological characteristics. Here, we will focus on the available literature reporting the epidemiology of AKI in critically ill patients. Sepsis, major surgery, and nephrotoxic drugs are the main causes of AKI in these patients, and its occurrence is associated with an increased risk for sustained chronic kidney injury. We also discuss the concept of renal angina as a possible future concept for improved clinical risk stratification to detect AKI. In this regard, we emphasize the importance of the use of novel biomarkers in the diagnosis of AKI, as they hold the potential to improve early diagnosis and prevention in the clinical setting.

Clinical application of removable partial dentures using thermoplastic resin-part I: definition and indication of non-metal clasp dentures.

Science.gov (United States)

Fueki, Kenji; Ohkubo, Chikahiro; Yatabe, Masaru; Arakawa, Ichiro; Arita, Masahiro; Ino, Satoshi; Kanamori, Toshikazu; Kawai, Yasuhiko; Kawara, Misao; Komiyama, Osamu; Suzuki, Tetsuya; Nagata, Kazuhiro; Hosoki, Maki; Masumi, Shin-Ichi; Yamauchi, Mutsuo; Aita, Hideki; Ono, Takahiro; Kondo, Hisatomo; Tamaki, Katsushi; Matsuka, Yoshizo; Tsukasaki, Hiroaki; Fujisawa, Masanori; Baba, Kazuyoshi; Koyano, Kiyoshi; Yatani, Hirofumi

2014-01-01

This position paper proposes a definition and naming standard for removable partial dentures (RPDs) using thermoplastic resin, and presents a guideline for clinical application. A panel of 14 experts having broad experience with clinical application of RPDs using thermoplastic resin was selected from members of the Japan Prosthodontic Society. At a meeting of the panel, "non-metal clasp denture" was referred as the generic name of RPDs with retentive elements (resin clasps) made of thermoplastic resin. The panel classified non-metal clasp dentures into two types: one with a flexible structure that lacks a metal framework and the other having a rigid structure that includes a metal framework. According to current prosthetic principles, flexible non-metal clasp dentures are not recommended as definitive dentures, except for limited cases such as patients with a metal allergy. Rigid non-metal clasp dentures are recommended in cases where patients will not accept metal clasps for esthetic reasons. Non-metal clasp dentures should follow the same design principles as conventional RPDs using metal clasps. Copyright © 2013 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

Value of the free light chain analysis in the clinical evaluation of response in multiple myeloma patients receiving anti-myeloma therapy

DEFF Research Database (Denmark)

Toftmann Hansen, Charlotte; Pedersen, Per T.; Jensen, Bo Amdi

Value of the free light chain analysis in the clinical evaluation of response in multiple myeloma patients receiving anti-myeloma therapy.......Value of the free light chain analysis in the clinical evaluation of response in multiple myeloma patients receiving anti-myeloma therapy....

Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings.

Science.gov (United States)

Mtove, George; Kimani, Joshua; Kisinza, William; Makenga, Geofrey; Mangesho, Peter; Duparc, Stephan; Nakalembe, Miriam; Phiri, Kamija S; Orrico, Russell; Rojo, Ricardo; Vandenbroucke, Pol

2018-03-22

Multinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials. During the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the "Sponsoring Entities" for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs. Engagement

The headache to subjects with multiple sclerosis: clinical and imaging study

International Nuclear Information System (INIS)

Moldovanu, Ion; Voiticovschi-Iosob, Cristina

2011-01-01

The present study showed clinical and imaging particularities of primary headache to subjects with multiple sclerosis. From the total number of 28 patients included in this study 22 (78,57%) had headache accuses (3 men and 19 women). Was observed a high prevalence of tension type headache, present to 10 of the 22 patients (45.45%). Migraine was diagnosed to 8 respondents (36.36 %). In 4 cases was found a combination of migraine and tension type headache (8.1%). Headache was more common to women with multiple sclerosis (MS) than to men. Neuroimaging of MS patients indicates the fact that the presence of demyelinating disease in the brainstem, midbrain, periaqueductal gray substance is associated with an increased risk of headache, migraine characteristics (migraine-like). Psychometric test have revealed a high level of depression and anxiety in patients with MS and chronic headache. (authors)

Emergency cesarean section and the 30-minute rule: definitions.

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Schauberger, Charles W; Chauhan, Suneet P

2009-03-01

We explored the role that lack of a standard definition and heterogeneity in patient selection criteria in the literature might have on the apparent inability to routinely begin an emergency cesarean section in less than 30 minutes. A review of the literature on emergency cesarean delivery was performed. Although there are some similarities in definitions and the criteria used for patient selection in multiple studies, the variability in the definitions could be responsible for some of the apparent timeliness performance deficiency in the literature. A standard definition and directions for future research are suggested.

Evaluation of Clinical Gait Analysis parameters in patients affected by Multiple Sclerosis: Analysis of kinematics.

Science.gov (United States)

Severini, Giacomo; Manca, Mario; Ferraresi, Giovanni; Caniatti, Luisa Maria; Cosma, Michela; Baldasso, Francesco; Straudi, Sofia; Morelli, Monica; Basaglia, Nino

2017-06-01

Clinical Gait Analysis is commonly used to evaluate specific gait characteristics of patients affected by Multiple Sclerosis. The aim of this report is to present a retrospective cross-sectional analysis of the changes in Clinical Gait Analysis parameters in patients affected by Multiple Sclerosis. In this study a sample of 51 patients with different levels of disability (Expanded Disability Status Scale 2-6.5) was analyzed. We extracted a set of 52 parameters from the Clinical Gait Analysis of each patient and used statistical analysis and linear regression to assess differences among several groups of subjects stratified according to the Expanded Disability Status Scale and 6-Minutes Walking Test. The impact of assistive devices (e.g. canes and crutches) on the kinematics was also assessed in a subsample of patients. Subjects showed decreased range of motion at hip, knee and ankle that translated in increased pelvic tilt and hiking. Comparison between the two stratifications showed that gait speed during 6-Minutes Walking Test is better at discriminating patients' kinematics with respect to Expanded Disability Status Scale. Assistive devices were shown not to significantly impact gait kinematics and the Clinical Gait Analysis parameters analyzed. We were able to characterize disability-related trends in gait kinematics. The results presented in this report provide a small atlas of the changes in gait characteristics associated with different disability levels in the Multiple Sclerosis population. This information could be used to effectively track the progression of MS and the effect of different therapies. Copyright © 2017. Published by Elsevier Ltd.

IOM and DHHS meeting on making clinical practice guidelines appropriate for patients with multiple chronic conditions.

Science.gov (United States)

Goodman, Richard A; Boyd, Cynthia; Tinetti, Mary E; Von Kohorn, Isabelle; Parekh, Anand K; McGinnis, J Michael

2014-01-01

The increasing prevalence of Americans with multiple (2 or more) chronic conditions raises concerns about the appropriateness and applicability of clinical practice guidelines for patient management. Most guidelines clinicians currently rely on have been designed with a single chronic condition in mind, and many such guidelines are inattentive to issues related to comorbidities. In response to the need for guideline developers to address comorbidities in guidelines, the Department of Health and Human Services convened a meeting in May 2012 in partnership with the Institute of Medicine to identify principles and action options. Eleven principles to improve guidelines' attentiveness to the population with multiple chronic conditions were identified during the meeting. They are grouped into 3 interrelated categories: (1) principles intended to improve the stakeholder technical process for developing guidelines; (2) principles intended to strengthen content of guidelines in terms of multiple chronic conditions; and (3) principles intended to increase focus on patient-centered care. This meeting built upon previously recommended actions by identifying additional principles and options for government, guideline developers, and others to use in strengthening the applicability of clinical practice guidelines to the growing population of people with multiple chronic conditions. The suggested principles are helping professional societies to improve guidelines' attentiveness to persons with multiple chronic conditions.

Application of a simplified definition of diastolic function in severe sepsis and septic shock.

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Lanspa, Michael J; Gutsche, Andrea R; Wilson, Emily L; Olsen, Troy D; Hirshberg, Eliotte L; Knox, Daniel B; Brown, Samuel M; Grissom, Colin K

2016-08-04

Left ventricular diastolic dysfunction is common in patients with severe sepsis or septic shock, but the best approach to categorization is unknown. We assessed the association of common measures of diastolic function with clinical outcomes and tested the utility of a simplified definition of diastolic dysfunction against the American Society of Echocardiography (ASE) 2009 definition. In this prospective observational study, patients with severe sepsis or septic shock underwent transthoracic echocardiography within 24 h of onset of sepsis (median 4.3 h). We measured echocardiographic parameters of diastolic function and used random forest analysis to assess their association with clinical outcomes (28-day mortality and ICU-free days to day 28) and thereby suggest a simplified definition. We then compared patients categorized by the ASE 2009 definition and our simplified definition. We studied 167 patients. The ASE 2009 definition categorized only 35 % of patients. Random forest analysis demonstrated that the left atrial volume index and deceleration time, central to the ASE 2009 definition, were not associated with clinical outcomes. Our simplified definition used only e' and E/e', omitting the other measurements. The simplified definition categorized 87 % of patients. Patients categorized by either ASE 2009 or our novel definition had similar clinical outcomes. In both definitions, worsened diastolic function was associated with increased prevalence of ischemic heart disease, diabetes, and hypertension. A novel, simplified definition of diastolic dysfunction categorized more patients with sepsis than ASE 2009 definition. Patients categorized according to the simplified definition did not differ from patients categorized according to the ASE 2009 definition in respect to clinical outcome or comorbidities.

Clinically Effective Treatment of Fibromyalgia Pain With High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization.

Science.gov (United States)

Castillo-Saavedra, Laura; Gebodh, Nigel; Bikson, Marom; Diaz-Cruz, Camilo; Brandao, Rivail; Coutinho, Livia; Truong, Dennis; Datta, Abhishek; Shani-Hershkovich, Revital; Weiss, Michal; Laufer, Ilan; Reches, Amit; Peremen, Ziv; Geva, Amir; Parra, Lucas C; Fregni, Felipe

2016-01-01

Despite promising preliminary results in treating fibromyalgia (FM) pain, no neuromodulation technique has been adopted in clinical practice because of limited efficacy, low response rate, or poor tolerability. This phase II open-label trial aims to define a methodology for a clinically effective treatment of pain in FM by establishing treatment protocols and screening procedures to maximize efficacy and response rate. High-definition transcranial direct current stimulation (HD-tDCS) provides targeted subthreshold brain stimulation, combining tolerability with specificity. We aimed to establish the number of HD-tDCS sessions required to achieve a 50% FM pain reduction, and to characterize the biometrics of the response, including brain network activation pain scores of contact heat-evoked potentials. We report a clinically significant benefit of a 50% pain reduction in half (n = 7) of the patients (N = 14), with responders and nonresponders alike benefiting from a cumulative effect of treatment, reflected in significant pain reduction (P = .035) as well as improved quality of life (P = .001) over time. We also report an aggregate 6-week response rate of 50% of patients and estimate 15 as the median number of HD-tDCS sessions to reach clinically meaningful outcomes. The methodology for a pivotal FM neuromodulation clinical trial with individualized treatment is thus supported. Registered in Clinicaltrials.gov under registry number NCT01842009. In this article, an optimized protocol for the treatment of fibromyalgia pain with targeted subthreshold brain stimulation using high-definition transcranial direct current stimulation is outlined. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

International consensus on preliminary definitions of improvement in adult and juvenile myositis.

Science.gov (United States)

Rider, Lisa G; Giannini, Edward H; Brunner, Hermine I; Ruperto, Nicola; James-Newton, Laura; Reed, Ann M; Lachenbruch, Peter A; Miller, Frederick W

2004-07-01

To use a core set of outcome measures to develop preliminary definitions of improvement for adult and juvenile myositis as composite end points for therapeutic trials. Twenty-nine experts in the assessment of myositis achieved consensus on 102 adult and 102 juvenile paper patient profiles as clinically improved or not improved. Two hundred twenty-seven candidate definitions of improvement were developed using the experts' consensus ratings as a gold standard and their judgment of clinically meaningful change in the core set of measures. Seventeen additional candidate definitions of improvement were developed from classification and regression tree analysis, a data-mining decision tree tool analysis. Six candidate definitions specifying percentage change or raw change in the core set of measures were developed using logistic regression analysis. Adult and pediatric working groups ranked the 13 top-performing candidate definitions for face validity, clinical sensibility, and ease of use, in which the sensitivity and specificity were >/=75% in adult, pediatric, and combined data sets. Nominal group technique was used to facilitate consensus formation. The definition of improvement (common to the adult and pediatric working groups) that ranked highest was 3 of any 6 of the core set measures improved by >/=20%, with no more than 2 worse by >/=25% (which could not include manual muscle testing to assess strength). Five and 4 additional preliminary definitions of improvement for adult and juvenile myositis, respectively, were also developed, with several definitions common to both groups. Participants also agreed to prospectively test 6 logistic regression definitions of improvement in clinical trials. Consensus preliminary definitions of improvement were developed for adult and juvenile myositis, and these incorporate clinically meaningful change in all myositis core set measures in a composite end point. These definitions require prospective validation, but they are now

Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research

Directory of Open Access Journals (Sweden)

Hanson Janice L

2012-11-01

Full Text Available Abstract Background There are no empirically-grounded criteria or tools to define or benchmark the quality of outpatient clinical documentation. Outpatient clinical notes document care, communicate treatment plans and support patient safety, medical education, medico-legal investigations and reimbursement. Accurately describing and assessing quality of clinical documentation is a necessary improvement in an increasingly team-based healthcare delivery system. In this paper we describe the quality of outpatient clinical notes from the perspective of multiple stakeholders. Methods Using purposeful sampling for maximum diversity, we conducted focus groups and individual interviews with clinicians, nursing and ancillary staff, patients, and healthcare administrators at six federal health care facilities between 2009 and 2011. All sessions were audio-recorded, transcribed and qualitatively analyzed using open, axial and selective coding. Results The 163 participants included 61 clinicians, 52 nurse/ancillary staff, 31 patients and 19 administrative staff. Three organizing themes emerged: 1 characteristics of quality in clinical notes, 2 desired elements within the clinical notes and 3 system supports to improve the quality of clinical notes. We identified 11 codes to describe characteristics of clinical notes, 20 codes to describe desired elements in quality clinical notes and 11 codes to describe clinical system elements that support quality when writing clinical notes. While there was substantial overlap between the aspects of quality described by the four stakeholder groups, only clinicians and administrators identified ease of translation into billing codes as an important characteristic of a quality note. Only patients rated prioritization of their medical problems as an aspect of quality. Nurses included care and education delivered to the patient, information added by the patient, interdisciplinary information, and infection alerts as important

Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research.

Science.gov (United States)

Hanson, Janice L; Stephens, Mark B; Pangaro, Louis N; Gimbel, Ronald W

2012-11-19

There are no empirically-grounded criteria or tools to define or benchmark the quality of outpatient clinical documentation. Outpatient clinical notes document care, communicate treatment plans and support patient safety, medical education, medico-legal investigations and reimbursement. Accurately describing and assessing quality of clinical documentation is a necessary improvement in an increasingly team-based healthcare delivery system. In this paper we describe the quality of outpatient clinical notes from the perspective of multiple stakeholders. Using purposeful sampling for maximum diversity, we conducted focus groups and individual interviews with clinicians, nursing and ancillary staff, patients, and healthcare administrators at six federal health care facilities between 2009 and 2011. All sessions were audio-recorded, transcribed and qualitatively analyzed using open, axial and selective coding. The 163 participants included 61 clinicians, 52 nurse/ancillary staff, 31 patients and 19 administrative staff. Three organizing themes emerged: 1) characteristics of quality in clinical notes, 2) desired elements within the clinical notes and 3) system supports to improve the quality of clinical notes. We identified 11 codes to describe characteristics of clinical notes, 20 codes to describe desired elements in quality clinical notes and 11 codes to describe clinical system elements that support quality when writing clinical notes. While there was substantial overlap between the aspects of quality described by the four stakeholder groups, only clinicians and administrators identified ease of translation into billing codes as an important characteristic of a quality note. Only patients rated prioritization of their medical problems as an aspect of quality. Nurses included care and education delivered to the patient, information added by the patient, interdisciplinary information, and infection alerts as important content. Perspectives of these four stakeholder

The definition of biochemical failure in patients treated with definitive radiotherapy

International Nuclear Information System (INIS)

Kattan, Michael W.; Fearn, Paul A.; Leibel, Steven; Potters, Louis

2000-01-01

Purpose: The American Society for Therapeutic Radiology and Oncology (ASTRO) published a definition for biochemical failure following treatment of prostate cancer. Others have noted difficulties with interpreting this definition and recommended modifications to accommodate special recurrence patterns. We have compared various modifications to the original ASTRO definition on our series of 1213 patients treated with transperineal permanent prostate brachytherapy. Methods and Materials: The ASTRO modifications we considered adjusted for (1) early censoring of nonrecurrent patients with rising prostate-specific antigen levels (PSA), (2) cumulative rather than consecutive rises (without a decrease) as evidence of recurrence, (3) both of the above, and (4) waiting 2 years before data analysis. The Kaplan-Meier method was used to compute the effects on recurrence rate for patients treated with and without neoadjuvant hormones. Results: With the original ASTRO definition, freedom from recurrence in our series of men who did not receive neoadjuvant hormones was 83% at 4 years. All of the modifications considered had statistically insignificant effects on freedom from recurrence rates, varying from 80% to 83% at 4 years. Patients treated with neoadjuvant hormones also showed very little sensitivity to the recurrence definition employed. Conclusion: Early censoring of equivocal patients and counting cumulative rather than consecutive rises in PSA (without a decrease) had little empiric effect on the ASTRO recurrence rates. However, we favor the addition of both these modifications to the ASTRO definition on conceptual grounds for evaluating patients following any modality (radiation or surgery), whereby a trend over multiple PSA values is used to judge failure.

Evidence on multimorbidity from definition to intervention: An overview of systematic reviews.

Science.gov (United States)

Xu, Xiaolin; Mishra, Gita D; Jones, Mark

2017-08-01

The increasing challenge of multiple chronic diseases (multimorbidity) requires more evidence-based knowledge and effective practice. In order to better understand the existing evidence on multimorbidity, we performed a systematic review of systematic reviews on multimorbidity with pre-established search strategies and exclusion criteria by searching multiple databases and grey literature. Of 8006 articles found, 53 systematic reviews (including meta-analysis and qualitative research synthesis performed in some reviews) that stated multimorbidity as the main focus were included, with 79% published during 2013-2016. Existing evidence on definition, measurement, prevalence, risk factors, health outcomes, clinical practice and medication (polypharmacy), and intervention and management were identified and synthesised. There were three major definitions from three perspectives. Seven studies on prevalence reported a range from 3.5% to 100%. As six studies showed, depression, hypertension, diabetes, arthritis, asthma, and osteoarthritis were prone to be comorbid with other conditions. Four groups of risk factors and eight multimorbidity associated outcomes were explored by five and six studies, respectively. Nine studies evaluated interventions, which could be categorized into either organizational or patient-oriented, the effects of these interventions were varied. Self-management process, priority setting and decision making in multimorbidity were synthesised by evidence from 4 qualitative systematic reviews. We were unable to draw solid conclusions from this overview due to the heterogeneity in methodology and inconsistent findings among included reviews. As suggested by all included studies, there is a need for prospective research, especially longitudinal cohort studies and randomized control trials, to provide more definitive evidence on multimorbidity. Copyright © 2017 Elsevier B.V. All rights reserved.

Retrieving clinically relevant diabetic retinopathy images using a multi-class multiple-instance framework

Science.gov (United States)

Chandakkar, Parag S.; Venkatesan, Ragav; Li, Baoxin

2013-02-01

Diabetic retinopathy (DR) is a vision-threatening complication from diabetes mellitus, a medical condition that is rising globally. Unfortunately, many patients are unaware of this complication because of absence of symptoms. Regular screening of DR is necessary to detect the condition for timely treatment. Content-based image retrieval, using archived and diagnosed fundus (retinal) camera DR images can improve screening efficiency of DR. This content-based image retrieval study focuses on two DR clinical findings, microaneurysm and neovascularization, which are clinical signs of non-proliferative and proliferative diabetic retinopathy. The authors propose a multi-class multiple-instance image retrieval framework which deploys a modified color correlogram and statistics of steerable Gaussian Filter responses, for retrieving clinically relevant images from a database of DR fundus image database.

Consensus Based Definition of Growth Restriction in the Newborn.

Science.gov (United States)

Beune, Irene M; Bloomfield, Frank H; Ganzevoort, Wessel; Embleton, Nicholas D; Rozance, Paul J; van Wassenaer-Leemhuis, Aleid G; Wynia, Klaske; Gordijn, Sanne J

2018-05-01

To develop a consensus definition of growth restriction in the newborn that can be used clinically to identify newborn infants at risk and in research to harmonize reporting and definition in the current absence of a gold standard. An international panel of pediatric leaders in the field of neonatal growth were invited to participate in an electronic Delphi procedure using standardized methods and predefined consensus rules. Responses were fed back at group-level and the list of participants was provided. Nonresponders were excluded from subsequent rounds. In the first round, variables were scored on a 5-point Likert scale; in subsequent rounds, inclusion of variables and cut-offs were determined with a 70% level of agreement. In the final round participants selected the ultimate algorithm. In total, 57 experts participated in the first round; 79% completed the procedure. Consensus was reached on the following definition: birth weight less than the third percentile, or 3 out of the following: birth weight definition for growth restriction in the newborn. This definition recognizes that infants with birth weights 10th percentile can be growth restricted. This definition can be adopted in clinical practice and in clinical trials to better focus on newborns at risk, and is complementary to the previously determined definition of fetal growth restriction. Copyright © 2017 Elsevier Inc. All rights reserved.

The interpretation of physical activity, exercise, and sedentary behaviours by persons with multiple sclerosis.

Science.gov (United States)

Kinnett-Hopkins, Dominique; Learmonth, Yvonne; Hubbard, Elizabeth; Pilutti, Lara; Roberts, Sarah; Fanning, Jason; Wójcicki, Thomas; McAuley, Edward; Motl, Robert

2017-11-07

This study adopted a qualitative research design with directed content analysis and examined the interpretations of physical activity, exercise, and sedentary behaviour by persons with multiple sclerosis. Fifty three persons with multiple sclerosis who were enrolled in an exercise trial took part in semi-structured interviews regarding personal interpretations of physical activity, exercise, and sedentary behaviours. Forty three percent of participants indicated a consistent understanding of physical activity, 42% of participants indicated a consistent understanding of exercise, and 83% of participants indicated a consistent understanding of sedentary behaviour with the standard definitions. There was evidence of definitional ambiguity (i.e., 57, 58, and 11% of the sample for physical activity, exercise, and sedentary behaviour, respectively); 6% of the sample inconsistently defined sedentary behaviour with standard definitions. Some participants described physical activity in a manner that more closely aligned with exercise and confused sedentary behaviour with exercise or sleeping/napping. Results highlight the need to provide and utilise consistent definitions for accurate understanding, proper evaluation and communication of physical activity, exercise, and sedentary behaviours among persons with multiple sclerosis. The application of consistent definitions may minimise ambiguity, alleviate the equivocality of findings in the literature, and translate into improved communication about these behaviours in multiple sclerosis. Implications for Rehabilitation The symptoms of multiple sclerosis can be managed through participation in physical activity and exercise. Persons with multiple sclerosis are not engaging in sufficient levels of physical activity and exercise for health benefits. Rehabilitation professionals should use established definitions of physical activity, exercise, and sedentary behaviours when communicating about these behaviours among persons with

Clinical importance of neutralising antibodies against interferon beta in patients with relapsing-remitting multiple sclerosis

DEFF Research Database (Denmark)

Sorensen, Per Soelberg; Ross, Christian; Clemmesen, Katja Maria

2003-01-01

Interferon beta is the first-line treatment for relapsing-remitting multiple sclerosis, but the drug can induce neutralising antibodies against itself, which might reduce effectiveness. We aimed to assess the clinical effect of neutralising antibodies....

Validating archetypes for the Multiple Sclerosis Functional Composite.

Science.gov (United States)

Braun, Michael; Brandt, Alexander Ulrich; Schulz, Stefan; Boeker, Martin

2014-08-03

Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions.This case study provides evidence that both community- and tool-enabled review processes

Multiple Sclerosis and autoimmune diseases: clinical cases and review of the literature

Directory of Open Access Journals (Sweden)

A. Protti

2011-09-01

Full Text Available Multiple sclerosis (MS, the most frequent demyelinating disease in adults, is thought to be an autoimmune disease. Symptoms and signs observed in MS reflect lesions present mainly in the white matter of the central nervous system (CNS. The diagnosis remains difficult, at least concerning presenting symptoms, because of their low specificity. Diagnosis criteria are usually based on dissemination of signs in time and space, evoked potentials, findings of magnetic resonance imaging, results of cerebrospinal fluid examination, and the exclusion of other diagnosis possibly explaining the clinical signs. However, no clinical and paraclinical investigation can distinguish with certainity MS from other conditions such as autoimmune or inflammatory diseases predominantly affecting the central nervous system. These other disorders include systemic lupus erythematosus, antiphospholipid syndrome, Behcet disease, Sjogren syndrome, sarcoidosis and vasculitides. We present four clinical cases showing the difficulty in reaching a proper diagnosis...

[Recommendations for the clinical use of motor evoked potentials in multiple sclerosis].

Science.gov (United States)

Fernández, V; Valls-Sole, J; Relova, J L; Raguer, N; Miralles, F; Dinca, L; Taramundi, S; Costa-Frossard, L; Ferrandiz, M; Ramió-Torrentà, Ll; Villoslada, P; Saiz, A; Calles, C; Antigüedad, A; Alvarez-Cermeño, J C; Prieto, J M; Izquierdo, G; Montalbán, X; Fernández, O

2013-09-01

To establish clinical guidelines for the clinical use and interpretation of motor evoked potentials (MEP) in diagnosing and monitoring patients with multiple sclerosis (MS). Recommendations for MEP use and interpretation will help us rationalise and optimise resources used in MS patient diagnosis and follow up. We completed an extensive literature review and pooled our own data to produce a consensus statement with recommendations for the clinical use of MEPs in the study of MS. MEPs, in addition to spinal and cranial magnetic resonance imaging (MRI), help us diagnose and assess MS patients whose disease initially presents as spinal cord syndrome and those with non-specific brain MRI findings, or a normal brain MRI and clinical signs of MS. Whenever possible, a multimodal evoked potential study should be performed on patients with suspected MS in order to demonstrate involvement of the motor pathway which supports a diagnosis of dissemination in space. Copyright © 2012 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

Time for a neonatal-specific consensus definition for sepsis.

Science.gov (United States)

Wynn, James L; Wong, Hector R; Shanley, Thomas P; Bizzarro, Matthew J; Saiman, Lisa; Polin, Richard A

2014-07-01

To review the accuracy of the pediatric consensus definition of sepsis in term neonates and to determine the definition of neonatal sepsis used. The review focused primarily on pediatric literature relevant to the topic of interest. Neonatal sepsis is variably defined based on a number of clinical and laboratory criteria that make the study of this common and devastating condition very difficult. Diagnostic challenges and uncertain disease epidemiology necessarily result from a variable definition of disease. In 2005, intensivists caring for children recognized that as new drugs became available, children would be increasingly studied and thus, pediatric-specific consensus definitions were needed. Pediatric sepsis criteria are not accurate for term neonates and have not been examined in preterm neonates for whom the developmental stage influences aberrations associated with host immune response. Thus, specific consensus definitions for both term and preterm neonates are needed. Such definitions are critical for the interpretation of observational studies, future training of scientists and practitioners, and implementation of clinical trials in neonates.

42 CFR 55a.101 - Definitions.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Definitions. 55a.101 Section 55a.101 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS PROGRAM GRANTS FOR BLACK LUNG CLINICS General Provisions § 55a.101 Definitions. Act, as used in this part, means the Federal Mine Safety...

Ties that bind: multiple relationships between clinical researchers and the pharmaceutical industry.

Science.gov (United States)

Henry, David; Doran, Evan; Kerridge, Ian; Hill, Suzanne; McNeill, Paul M; Day, Richard

2005-11-28

It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

LENUS (Irish Health Repository)

Kubiak, Christine

2009-10-16

Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN

Directory of Open Access Journals (Sweden)

Sanz Nuria

2009-10-01

Full Text Available Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.; diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.; and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and

Feasibility and Clinical Utility of High-definition Transcranial Direct Current Stimulation in the Treatment of Persistent Hallucinations in Schizophrenia.

Science.gov (United States)

Bose, A; Shivakumar, V; Chhabra, H; Parlikar, R; Sreeraj, V S; Dinakaran, D; Narayanaswamy, J C; Venkatasubramanian, G

2017-12-01

Persistent auditory verbal hallucination is a clinically significant problem in schizophrenia. Recent studies suggest a promising role for add-on transcranial direct current stimulation (tDCS) in treatment. An optimised version of tDCS, namely high-definition tDCS (HD-tDCS), uses smaller electrodes arranged in a 4x1 ring configuration and may offer more focal and predictable neuromodulation than conventional tDCS. This case report illustrates the feasibility and clinical utility of add-on HD-tDCS over the left temporoparietal junction in a 4x1 ring configuration to treat persistent auditory verbal hallucination in schizophrenia.

Definition and delineation of the clinical target volume for rectal cancer

International Nuclear Information System (INIS)

Roels, Sarah; Duthoy, Wim; Haustermans, Karin; Penninckx, Freddy; Vandecaveye, Vincent; Boterberg, Tom; Neve, Wilfried de

2006-01-01

Purpose: Optimization of radiation techniques to maximize local tumor control and to minimize small bowel toxicity in locally advanced rectal cancer requires proper definition and delineation guidelines for the clinical target volume (CTV). The purpose of this investigation was to analyze reported data on the predominant locations and frequency of local recurrences and lymph node involvement in rectal cancer, to propose a definition of the CTV for rectal cancer and guidelines for its delineation. Methods and Materials: Seven reports were analyzed to assess the incidence and predominant location of local recurrences in rectal cancer. The distribution of lymphatic spread was analyzed in another 10 reports to record the relative frequency and location of metastatic lymph nodes in rectal cancer, according to the stage and level of the primary tumor. Results: The mesorectal, posterior, and inferior pelvic subsites are most at risk for local recurrences, whereas lymphatic tumor spread occurs mainly in three directions: upward into the inferior mesenteric nodes; lateral into the internal iliac lymph nodes; and, in a few cases, downward into the external iliac and inguinal lymph nodes. The risk for recurrence or lymph node involvement is related to the stage and the level of the primary lesion. Conclusion: Based on a review of articles reporting on the incidence and predominant location of local recurrences and the distribution of lymphatic spread in rectal cancer, we defined guidelines for CTV delineation including the pelvic subsites and lymph node groups at risk for microscopic involvement. We propose to include the primary tumor, the mesorectal subsite, and the posterior pelvic subsite in the CTV in all patients. Moreover, the lateral lymph nodes are at high risk for microscopic involvement and should also be added in the CTV

Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†.

Science.gov (United States)

Kramar, A; Negrier, S; Sylvester, R; Joniau, S; Mulders, P; Powles, T; Bex, A; Bonnetain, F; Bossi, A; Bracarda, S; Bukowski, R; Catto, J; Choueiri, T K; Crabb, S; Eisen, T; El Demery, M; Fitzpatrick, J; Flamand, V; Goebell, P J; Gravis, G; Houédé, N; Jacqmin, D; Kaplan, R; Malavaud, B; Massard, C; Melichar, B; Mourey, L; Nathan, P; Pasquier, D; Porta, C; Pouessel, D; Quinn, D; Ravaud, A; Rolland, F; Schmidinger, M; Tombal, B; Tosi, D; Vauleon, E; Volpe, A; Wolter, P; Escudier, B; Filleron, T

2015-12-01

In clinical trials, the use of intermediate time-to-event end points (TEEs) is increasingly common, yet their choice and definitions are not standardized. This limits the usefulness for comparing treatment effects between studies. The aim of the DATECAN Kidney project is to clarify and recommend definitions of TEE in renal cell cancer (RCC) through a formal consensus method for end point definitions. A formal modified Delphi method was used for establishing consensus. From a 2006-2009 literature review, the Steering Committee (SC) selected 9 TEE and 15 events in the nonmetastatic (NM) and metastatic/advanced (MA) RCC disease settings. Events were scored on the range of 1 (totally disagree to include) to 9 (totally agree to include) in the definition of each end point. Rating Committee (RC) experts were contacted for the scoring rounds. From these results, final recommendations were established for selecting pertinent end points and the associated events. Thirty-four experts scored 121 events for 9 end points. Consensus was reached for 31%, 43% and 85% events during the first, second and third rounds, respectively. The expert recommend the use of three and two endpoints in NM and MA setting, respectively. In the NM setting: disease-free survival (contralateral RCC, appearance of metastases, local or regional recurrence, death from RCC or protocol treatment), metastasis-free survival (appearance of metastases, regional recurrence, death from RCC); and local-regional-free survival (local or regional recurrence, death from RCC). In the MA setting: kidney cancer-specific survival (death from RCC or protocol treatment) and progression-free survival (death from RCC, local, regional, or metastatic progression). The consensus method revealed that intermediate end points have not been well defined, because all of the selected end points had at least one event definition for which no consensus was obtained. These clarified definitions of TEE should become standard practice in

The recolonization hypothesis in a full-mouth or multiple-session treatment protocol : a blinded, randomized clinical trial

NARCIS (Netherlands)

Zijnge, Vincent; Meijer, Henriette F.; Lie, Mady-Ann; Tromp, Jan A. H.; Degener, John E.; Harmsen, Hermie J. M.; Abbas, Frank

P>Aim To test recolonization of periodontal lesions after full-mouth scaling and root planing (FM-SRP) or multiple session-SRP (MS-SRP) in a randomized clinical trial and whether FM-SRP and MS-SRP result in different clinical outcomes. Materials and Methods Thirty-nine subjects were randomly

An Interactive Platform to Visualize Data-Driven Clinical Pathways for the Management of Multiple Chronic Conditions.

Science.gov (United States)

Zhang, Yiye; Padman, Rema

2017-01-01

Patients with multiple chronic conditions (MCC) pose an increasingly complex health management challenge worldwide, particularly due to the significant gap in our understanding of how to provide coordinated care. Drawing on our prior research on learning data-driven clinical pathways from actual practice data, this paper describes a prototype, interactive platform for visualizing the pathways of MCC to support shared decision making. Created using Python web framework, JavaScript library and our clinical pathway learning algorithm, the visualization platform allows clinicians and patients to learn the dominant patterns of co-progression of multiple clinical events from their own data, and interactively explore and interpret the pathways. We demonstrate functionalities of the platform using a cluster of 36 patients, identified from a dataset of 1,084 patients, who are diagnosed with at least chronic kidney disease, hypertension, and diabetes. Future evaluation studies will explore the use of this platform to better understand and manage MCC.

High-definition optical coherence tomography - an aid to clinical practice and research in dermatology.

Science.gov (United States)

Cao, Taige; Tey, Hong Liang

2015-09-01

At present, beyond clinical assessment, the diagnosis of skin diseases is primarily made histologically. However, skin biopsies have many disadvantages, including pain, scarring, risk of infection, and sampling error. With recent advances in skin imaging technology, the clinical use of imaging methods for the practical management of skin diseases has become an option. The in vivo high-definition optical coherence tomography (HD-OCT) has recently been developed and commercialized (Skintell; Agfa, Belgium). Compared with conventional OCT, it has a higher resolution; compared with reflectance confocal microscopy, it has a shorter time for image acquisition as well as a greater penetration depth and a larger field of view. HD-OCT is promising but much work is still required to develop it from a research tool to a valuable adjunct for the noninvasive diagnosis of skin lesions. Substantial work has been done to identify HD-OCT features in various diseases but interpretation can be time-consuming and tedious. Projects aimed at automating these processes and improving image quality are currently under way. © 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

Association of genetic variants in VEGF-A with clinical recurrence in prostate cancer patients treated with definitive radiotherapy

Energy Technology Data Exchange (ETDEWEB)

Langsenlehner, T.; Thurner, E.M.; Kapp, K.S. [Medical University of Graz, Department of Therapeutic Radiology and Oncology, Graz (Austria); Renner, W. [Medical University of Graz, Clinical Institute of Medical and Chemical Laboratory Diagnostics, Graz (Austria); Gerger, A. [Medical University of Graz, Division of Oncology, Department of Internal Medicine, Graz (Austria); Langsenlehner, U. [GKK Outpatient Department, Division of Internal Medicine, Graz (Austria)

2014-04-15

Vascular endothelial growth factor-A (VEGF-A), a key regulator of tumor-induced angiogenesis, is critical for tumor growth and metastasization. The goal of the present study was to evaluate the prognostic value of VEGF single nucleotide polymorphisms (SNPs) and haplotypes for clinical recurrence after definitive radiotherapy for prostate cancer. The association of seven VEGF-A polymorphisms and their haplotypes with clinical recurrence (defined as the occurrence of local recurrence and/or distant metastases) in 496 prostate cancer patients treated with definitive radiotherapy were investigated. Genotypes were determined by 5'-nuclease (TaqMan) assays; haplotypes were analyzed using the Haploview program. Within a median follow-up time of 80 months, 44 patients (9%) developed clinical recurrences. Haplotype analysis showed two separate blocks of high-linkage disequilibrium, formed by five polymorphisms (-2578C > A, -2489C > T, -1498C > T, -634G > C, -7C > T) upstream of the coding sequence (CCCCC, ATTGC, CCCGC, ATTGT) and two polymorphisms (936C > T, 1612G > A) downstream of the coding sequence (CA, CG, TG). Carriers of at least 1 copy of the ATTGC haplotype were at higher risk of recurrence (hazard ratio [HR] 3.83; 95%CI 1.48-9.90, p=0.006); for carriers of 2 copies, the HR was 4.85 (95%CI 1.72-13.6; p=0.003). In multivariate analysis, patients harboring at least one copy of the ATTGC haplotype remained at increased risk of recurrence (HR 3.63, 95%CI 1.38-9.55, p=0.009); in patients carrying 2 copies, the HR was 4.72 (95%CI 1.64-13.6, p=0.004). Our findings indicate that the VEGF-A ATTGC haplotype may predict clinical recurrence in prostate cancer patients treated with radiotherapy. (orig.)

Multiple organ definition in CT using a Bayesian approach for 3D model fitting

Science.gov (United States)

Boes, Jennifer L.; Weymouth, Terry E.; Meyer, Charles R.

1995-08-01

Organ definition in computed tomography (CT) is of interest for treatment planning and response monitoring. We present a method for organ definition using a priori information about shape encoded in a set of biometric organ models--specifically for the liver and kidney-- that accurately represents patient population shape information. Each model is generated by averaging surfaces from a learning set of organ shapes previously registered into a standard space defined by a small set of landmarks. The model is placed in a specific patient's data set by identifying these landmarks and using them as the basis for model deformation; this preliminary representation is then iteratively fit to the patient's data based on a Bayesian formulation of the model's priors and CT edge information, yielding a complete organ surface. We demonstrate this technique using a set of fifteen abdominal CT data sets for liver surface definition both before and after the addition of a kidney model to the fitting; we demonstrate the effectiveness of this tool for organ surface definition in this low-contrast domain.

[Acute schizophrenia concept and definition: investigation of a French psychiatrist population].

Science.gov (United States)

Baylé, F J; Misdrahi, D; Llorca, P M; Lançon, C; Olivier, V; Quintin, P; Azorin, J M

2005-01-01

For schizophrenic disorders, the clinical conception of "acute state" is widely used in clinical settings to assess the effectiveness of therapeutic programs as well as epidemiological studies. Schizophrenic-specific symptomatology modification, need for hospitalization, significant change in care, disturbances in social behavior or suicide attempts were all used to define acute schizophrenic state. The decision to hospitalize is frequently used to define acute state but refers to multiple factors such as mood disorder, suicide attempts, drug abuse or social and environmental problems. Indeed, several and distinct definitions in a criteria basis form are available but no one has reached consensus. Because recognition of acute schizophrenic state remains based on the subjective clinician's advice, epidemiological and therapeutic studies fail in validity and reliability. The aim of the study was to evaluate how a population of French psychiatrists define criteria and therapeutic targets of acute schizophrenic state in their clinical practice. Psychiatrists filled out a self administered interview. At the time the interview was given, clinicians were notified that they were participating in a clinical consensus survey about schizophrenia. Six major indicators for acute state definition based on the literature data were proposed: general schizophrenic symptomatology modification (depression, anxiety, agitation, impulsivity/aggressiveness), specific schizophrenic symptomatology modification (positive symptoms, negative symptoms, disorganization), need for hospitalization, significant change in care, disturbance in social behavior and lastly, suicidal behavior. Minimal duration (1.2 or 4 weeks) of general and specific schizophrenic symptomatology modification required to define acute state were evaluated. The booklet included the 30 PANSS symptoms listed with their definitions. Among this symptom list, clinicians were instructed to select the ten criteria which they

Evaluation of the predictive value of a clinical worsening definition using 2-year outcomes in patients with pulmonary arterial hypertension: a REVEAL Registry analysis.

Science.gov (United States)

Frost, Adaani E; Badesch, David B; Miller, Dave P; Benza, Raymond L; Meltzer, Leslie A; McGoon, Michael D

2013-11-01

Time to clinical worsening has been proposed as a primary end point in clinical trials of pulmonary arterial hypertension (PAH); however, neither standardized nor validated definitions of clinical worsening across PAH trials exist. This study aims to evaluate a proposed definition of clinical worsening within a large prospective, observational registry of patients with PAH with respect to its value as a predictor of proximate (within 1 year) risk for subsequent major events (ie, death, transplantation, or atrial septostomy). We assessed overall 2-year survival and survival free from major events to determine the relationship between clinical worsening and major events among adults with hemodynamically defined PAH (N = 3,001). Freedom from clinical worsening was defined as freedom from worsening functional class (FC), a ≥ 15% reduction in 6-min walk distance (6MWD), all-cause hospitalization, or the introduction of parenteral prostacyclin analog therapy. In the 2 years of follow-up, 583 patients died. Four hundred twenty-six died after a documented clinical worsening event, including FC worsening (n = 128), a ≥ 15% reduction in 6MWD (n = 118), all-cause hospitalization (n = 370), or introduction of a prostacyclin analog (n = 91). Patients who experienced clinical worsening had significantly poorer subsequent 1-year survival postworsening than patients who did not worsen (P < .001). Clinical worsening was highly predictive of subsequent proximate mortality in this analysis from an observational study. These results validate the use of clinical worsening as a meaningful prognostic tool in clinical practice and as a primary end point in clinical trial design. ClinicalTrials.gov; No.: NCT00370214; URL: www.clinicaltrials.gov.

CT scan findings in three cases of multiple sclerosis with homonymous hemianopsia

International Nuclear Information System (INIS)

Arikado, Takuji; Ariga, Hiroko; Kase, Manabu; Nagata, Renpei; Tashiro, Kunio

1983-01-01

Three cases of clinically definite multiple sclerosis manifested homonymous hemianopsia. A 35-year-old female, in whom right optic neuritis developed as the initial symptom, manifested right homonymous hemianopsia 4 months later followed by cerebral symptoms another 4 months later. A 25-year-old male developed sudden brain stem and cerebellar symptoms associated with right abducens palsy and right homonymous hemianopsia. In a 26-year-old female developed right homonymous hemianopsia 13 years after the first attack of recurrent optic neuritis. CT-scan in these three cases revealed the presence of a ''plaque'' located in the white matter of the left occipital lobe in cases 1 and 2 and in the left peririgone white matter in case 3 as the causative lesion for the right homonymous hemianopsia. These findings indicate that the optic radiation may be involved in multiple sclerosis resulting in homonymous hemianopsia. CT scan is of value in determining the location of the affected intracranial lesion in multiple sclerosis. (author)

Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia.

Science.gov (United States)

Walsh, Michele C; Wilson-Costello, Deanna; Zadell, Arlene; Newman, Nancy; Fanaroff, Avroy

2003-09-01

Bronchopulmonary dysplasia (BPD) is the focus of many intervention trials, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. Thus, we wished to define BPD by a standardized oxygen saturation monitoring at 36 weeks corrected age, and compare this physiologic definition with the standard clinical definition of BPD based solely on oxygen administration. A total of 199 consecutive very low birthweight infants (VLBW, 501 to 1500 g birthweight) were assessed prospectively at 36+/-1 weeks corrected age. Neonates on positive pressure support or receiving >30% supplemental oxygen were assigned the outcome BPD. Those receiving or =88% for 60 minutes) or "BPD" (saturation reliability, test-retest reliability, and validity of the physiologic definition vs the clinical definition were assessed. A total of 199 VLBW were assessed, of whom 45 (36%) were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks corrected age. The physiologic definition identified 15 infants treated with oxygen who successfully passed the saturation monitoring test in room air. The physiologic definition diagnosed BPD in 30 (24%) of the cohort. All infants were safely studied. The test was highly reliable (inter-rater reliability, kappa=1.0; test-retest reliability, kappa=0.83) and highly correlated with discharge home in oxygen, length of hospital stay, and hospital readmissions in the first year of life. The physiologic definition of BPD is safe, feasible, reliable, and valid and improves the precision of the diagnosis of BPD. This may be of benefit in future multicenter clinical trials.

Clinical Features in a Danish Population-Based Cohort of Probable Multiple System Atrophy Patients

DEFF Research Database (Denmark)

Starhof, Charlotte; Korbo, Lise; Lassen, Christina Funch

2016-01-01

Background: Multiple system atrophy (MSA) is a rare, sporadic and progressive neurodegenerative disorder. We aimed to describe the clinical features of Danish probable MSA patients, evaluate their initial response to dopaminergic therapy and examine mortality. Methods: From the Danish National...... the criteria for probable MSA. We recorded clinical features, examined differences by MSA subtype and used Kaplan-Meier survival analysis to examine mortality. Results: The mean age at onset of patients with probable MSA was 60.2 years (range 36-75 years) and mean time to wheelchair dependency was 4.7 years...

CSF Proteomics Identifies Specific and Shared Pathways for Multiple Sclerosis Clinical Subtypes.

Directory of Open Access Journals (Sweden)

Timucin Avsar

Full Text Available Multiple sclerosis (MS is an immune-mediated, neuro-inflammatory, demyelinating and neurodegenerative disease of the central nervous system (CNS with a heterogeneous clinical presentation and course. There is a remarkable phenotypic heterogeneity in MS, and the molecular mechanisms underlying it remain unknown. We aimed to investigate further the etiopathogenesis related molecular pathways in subclinical types of MS using proteomic and bioinformatics approaches in cerebrospinal fluids of patients with clinically isolated syndrome, relapsing remitting MS and progressive MS (n=179. Comparison of disease groups with controls revealed a total of 151 proteins that are differentially expressed in clinically different MS subtypes. KEGG analysis using PANOGA tool revealed the disease related pathways including aldosterone-regulated sodium reabsorption (p=8.02x10-5 which is important in the immune cell migration, renin-angiotensin (p=6.88x10-5 system that induces Th17 dependent immunity, notch signaling (p=1.83x10-10 pathway indicating the activated remyelination and vitamin digestion and absorption pathways (p=1.73x10-5. An emerging theme from our studies is that whilst all MS clinical forms share common biological pathways, there are also clinical subtypes specific and pathophysiology related pathways which may have further therapeutic implications.

MRD Testing in Multiple Myeloma: From a Surrogate Marker of Clinical Outcomes to an Every-Day Clinical Tool.

Science.gov (United States)

Landgren, Ola

2018-01-01

Minimal residual disease (MRD) testing in multiple myeloma is here to stay. Studies show that MRD negativity is consistently associated with longer progression-free survival (PFS). It is just a matter of time until MRD negativity will become a regulatory endpoint for drug approval. Until that can happen, more analysis will be required to define the exact details of MRD in the regulatory setting. For example, for randomized studies there is need to define the amount of improvement in MRD negativity between the experimental arm and the control arm at a given time-point for a drug to obtain regulatory accelerated approval. Such efforts are underway. For the multiple myeloma field as a whole, important tasks for the (near) coming future are as follows: (1) to conduct or finalize the expanded analysis to define the exact details of MRD in the regulatory setting, (2) to develop new and better MRD assays-both more sensitive MRD assays for bone marrow aspirates and nonbone marrow aspirate-based assays (eg, blood-based and imaging-based MRD assays), and (3) to design novel clinical studies to formally assess the effect of MRD negativity in clinical decision making. The aim with this issue of the Journal is to provide a deep and comprehensive summary of the latest MRD knowledge in the field, and to outline future directions. Copyright © 2018 Elsevier Inc. All rights reserved.

Proteomic profiling in multiple sclerosis clinical courses reveals potential biomarkers of neurodegeneration.

Directory of Open Access Journals (Sweden)

Maria Liguori

Full Text Available The aim of our project was to perform an exploratory analysis of the cerebrospinal fluid (CSF proteomic profiles of Multiple Sclerosis (MS patients, collected in different phases of their clinical course, in order to investigate the existence of peculiar profiles characterizing the different MS phenotypes. The study was carried out on 24 Clinically Isolated Syndrome (CIS, 16 Relapsing Remitting (RR MS, 11 Progressive (Pr MS patients. The CSF samples were analysed using the Matrix Assisted Laser Desorption Ionisation Time Of Flight (MALDI-TOF mass spectrometer in linear mode geometry and in delayed extraction mode (m/z range: 1000-25000 Da. Peak lists were imported for normalization and statistical analysis. CSF data were correlated with demographic, clinical and MRI parameters. The evaluation of MALDI-TOF spectra revealed 348 peak signals with relative intensity ≥ 1% in the study range. The peak intensity of the signals corresponding to Secretogranin II and Protein 7B2 were significantly upregulated in RRMS patients compared to PrMS (p<0.05, whereas the signals of Fibrinogen and Fibrinopeptide A were significantly downregulated in CIS compared to PrMS patients (p<0.04. Additionally, the intensity of the Tymosin β4 peak was the only signal to be significantly discriminated between the CIS and RRMS patients (p = 0.013. Although with caution due to the relatively small size of the study populations, and considering that not all the findings remained significant after adjustment for multiple comparisons, in our opinion this mass spectrometry evaluation confirms that this technique may provide useful and important information to improve our understanding of the complex pathogenesis of MS.

Agitation in cognitive disorders:International Psychogeriatric Association provisional consensus clinical and research definition

OpenAIRE

Cummings, Jeffrey; Mintzer, Jacobo; Brodaty, Henry; Sano, Mary; Banerjee, Sube; Devanand, D. P.; Gauthier, Serge; Howard, Robert; Lanctôt, Krista; Lyketsos, Constantine G.; Peskind, Elaine; Porsteinsson, Anton P.; Reich, Edgardo; Sampaio, Cristina; Steffens, David

2015-01-01

Background: Agitation is common across neuropsychiatric disorders and contributes to disability, institutionalization, and diminished quality of life for patients and their caregivers. There is no consensus definition of agitation and no widespread agreement on what elements should be included in the syndrome. The International Psychogeriatric Association formed an Agitation Definition Work Group (ADWG) to develop a provisional consensus definition of agitation in patients with cognitive diso...

Late presentation of HIV infection: a consensus definition

DEFF Research Database (Denmark)

Antinori, A; Coenen, T; Costagiola, D

2010-01-01

clinical definition of late presentation. The objective of this article is to present a consensus definition of late presentation of HIV infection. Methods Over the past year, two initiatives have moved towards a harmonized definition. In spring 2009, they joined efforts to identify a common definition...... of what is meant by a 'late-presenting' patient. Results Two definitions were agreed upon, as follows. Late presentation: persons presenting for care with a CD4 count below 350 cells/muL or presenting with an AIDS-defining event, regardless of the CD4 cell count. Presentation with advanced HIV disease...... able to implement this definition (either on its own or alongside their own preferred definition) when reporting surveillance or research data relating to late presentation of HIV infection....

Addiction recovery: its definition and conceptual boundaries.

Science.gov (United States)

White, William L

2007-10-01

The addiction field's failure to achieve consensus on a definition of "recovery" from severe and persistent alcohol and other drug problems undermines clinical research, compromises clinical practice, and muddles the field's communications to service constituents, allied service professionals, the public, and policymakers. This essay discusses 10 questions critical to the achievement of such a definition and offers a working definition of recovery that attempts to meet the criteria of precision, inclusiveness, exclusiveness, measurability, acceptability, and simplicity. The key questions explore who has professional and cultural authority to define recovery, the defining ingredients of recovery, the boundaries (scope and depth) of recovery, and temporal benchmarks of recovery (when recovery begins and ends). The process of defining recovery touches on some of the most controversial issues within the addictions field.

21 CFR 54.2 - Definitions.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Definitions. 54.2 Section 54.2 Food and Drugs FOOD... or device in humans submitted in a marketing application or reclassification petition subject to this... $25,000, exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a...

The New Sepsis Definitions: Implications for the Basic and Translational Research Communities.

Science.gov (United States)

Coopersmith, Craig M; Deutschman, Clifford S

2017-03-01

New definitions of sepsis and septic shock were published in early 2016, updating old definitions that have not been revisited since 2001. These new definitions should profoundly affect sepsis research. In addition, these papers present clinical criteria for identifying infected patients who are highly likely to have or to develop sepsis or septic shock. In contrast to previous approaches, these new clinical criteria are evidence based. In this review, two of the authors of the new definitions detail the content of the papers and explore the implications for shock and sepsis researchers.

Sensitivity, Specificity, and Public-Health Utility of Clinical Case Definitions Based on the Signs and Symptoms of Cholera in Africa.

Science.gov (United States)

Nadri, Johara; Sauvageot, Delphine; Njanpop-Lafourcade, Berthe-Marie; Baltazar, Cynthia S; Banla Kere, Abiba; Bwire, Godfrey; Coulibaly, Daouda; Kacou N'Douba, Adele; Kagirita, Atek; Keita, Sakoba; Koivogui, Lamine; Landoh, Dadja E; Langa, Jose P; Miwanda, Berthe N; Mutombo Ndongala, Guy; Mwakapeje, Elibariki R; Mwambeta, Jacob L; Mengel, Martin A; Gessner, Bradford D

2018-04-01

During 2014, Africa reported more than half of the global suspected cholera cases. Based on the data collected from seven countries in the African Cholera Surveillance Network (Africhol), we assessed the sensitivity, specificity, and positive and negative predictive values of clinical cholera case definitions, including that recommended by the World Health Organization (WHO) using culture confirmation as the gold standard. The study was designed to assess results in real-world field situations in settings with recent cholera outbreaks or endemicity. From June 2011 to July 2015, a total of 5,084 persons with suspected cholera were tested for Vibrio cholerae in seven different countries of which 35.7% had culture confirmation. For all countries combined, the WHO case definition had a sensitivity = 92.7%, specificity = 8.1%, positive predictive value = 36.1%, and negative predictive value = 66.6%. Adding dehydration, vomiting, or rice water stools to the case definition could increase the specificity without a substantial decrease in sensitivity. Future studies could further refine our findings primarily by using more sensitive methods for cholera confirmation.

Diagnosis and treatment of latent tuberculosis in patients with multiple sclerosis, expert consensus. On behalf of the Colombian Association of Neurology, Committee of Multiple Sclerosis.

Science.gov (United States)

Navas, Carlos; Torres-Duque, Carlos A; Munoz-Ceron, Joe; Álvarez, Carlos; García, Juan R; Zarco, Luis; Vélez, Lázaro A; Awad, Carlos; Castro, Carlos Alberto

2018-01-01

Multiple sclerosis is an inflammatory and neurodegenerative demyelinating disease. Current treatment of multiple sclerosis focuses on the use of immunomodulatory, immunosuppressant, and selective immunosuppressant agents. Some of these medications may result in high risk of opportunistic infections including tuberculosis. The purpose of this study was to obtain consensus from a panel of neurologists, pulmonologists, infectious disease specialists, and epidemiology experts regarding the diagnosis, treatment, and monitoring of latent tuberculosis in patients with multiple sclerosis. A panel of experts in multiple sclerosis and tuberculosis was established. The methodological process was performed in three phases: definition of questions, answer using Delphi methodology, and the discussion of questions not agreed. Tuberculosis screening is suggested when multiple sclerosis drugs are prescribed. The recommended tests for latent tuberculosis are tuberculin and interferon gamma release test. When an anti-tuberculosis treatment is indicated, monitoring should be performed to determine liver enzyme values with consideration of age as well as comorbid conditions such as a history of alcoholism, age, obesity, concomitant hepatotoxic drugs, and history of liver disease. Latent tuberculosis should be considered in patients with multiple sclerosis who are going to be treated with immunomodulatory and immunosuppressant medications. Transaminase level monitoring is required on a periodic basis depending on clinical and laboratory characteristics. In addition to the liver impairment, other side effects should be considered when Isoniazid is prescribed.

Definitions of biochemical failure in prostate cancer following radiation therapy

International Nuclear Information System (INIS)

Taylor, Jeremy M.G.; Griffith, Kent A.; Sandler, Howard M.

2001-01-01

Purpose: The American Society for Therapeutic Radiology and Oncology (ASTRO) published a consensus panel definition of biochemical failure following radiation therapy for prostate cancer. In this paper, we develop a series of alternative definitions of biochemical failure. Using data from 688 patients, we evaluated the sensitivity and specificity of the various definitions, with respect to a defined 'clinically meaningful' outcome. Methods and Materials: The ASTRO definition of biochemical failure requires 3 consecutive rises in prostate-specific antigen (PSA). We considered several modifications to the standard definition: to require PSA rises of a certain magnitude, to consider 2 instead of 3 rises, to require the final PSA value to be greater than a fixed cutoff level, and to define biochemical failure based on the slope of PSA over 1, 1.5, or 2 years. A clinically meaningful failure is defined as local recurrence, distant metastases, initiation of unplanned hormonal therapy, unplanned radical prostatectomy, or a PSA>25 later than 6 months after radiation. Results: Requiring the final PSA in a series of consecutive rises to be larger than 1.5 ng/mL increased the specificity of biochemical failure. For a fixed specificity, defining biochemical failure based on 2 consecutive rises, or the slope over the last year, could increase the sensitivity by up to approximately 20%, compared to the ASTRO definition. Using a rule based on the slope over the previous year or 2 rises leads to a slightly earlier detection of biochemical failure than does the ASTRO definition. Even with the best rule, only approximately 20% of true failures are biochemically detected more than 1 year before the clinically meaningful event time. Conclusion: There is potential for improvement in the ASTRO consensus definition of biochemical failure. Further research is needed, in studies with long follow-up times, to evaluate the relationship between various definitions of biochemical failure and

Definition of healthcare-associated influenza: A review and results from an international survey.

Science.gov (United States)

Munier-Marion, Elodie; Bénet, Thomas; Vanhems, Philippe

2017-09-01

To describe definitions of healthcare-associated influenza (HAI) in recent literature and in hospitals participating in a survey of Society for Healthcare Epidemiology of America (SHEA) Research Network (SRN) members. A review with PubMed search was undertaken to retrieve articles published between 2008 and 2016, focusing on the subject headings "influenza, human" and "cross infection." Definitions of clinical influenza-like illness (ILI) and HAI were identified. An invitation to participate in the survey was sent to 218 SRN members via email. Of 75 articles on HAI included in the review, 30 presented a standardized definition of clinical ILI based on fever (100%), cough (80%), and sore throat (70%). Forty studies (53%) contained a standardized HAI definition, grounded on threshold delay from admission in 29 of them, this delay ranging from 48 to 196 hour (median: 72 hour). Fifty-five SRN members responded to the survey, with a standardized definition of HAI adopted by 76% of them. This definition was based on clinical features for 24%, virological features for 31%, and both for 45%. Fever (mean threshold: 38.0°C) was part of the definition for 82%. The features required most frequently in the clinical definition were cough (46%) and sore throat (26%). Median threshold delay between admission and symptoms onset adopted for HAI definition was 48 hour (range: 24-96 hour). This work underlined the heterogeneity of HAI definitions in different countries. A standardized definition would be helpful to evaluate HAI spread, outcomes in patients and healthcare systems, and the impact of prevention measures, including vaccination. © 2017 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Drawing Boundaries: The Difficulty in Defining Clinical Reasoning.

Science.gov (United States)

Young, Meredith; Thomas, Aliki; Lubarsky, Stuart; Ballard, Tiffany; Gordon, David; Gruppen, Larry D; Holmboe, Eric; Ratcliffe, Temple; Rencic, Joe; Schuwirth, Lambert; Durning, Steven J

2018-01-23

Clinical reasoning is an essential component of a health professional's practice. Yet clinical reasoning research has produced a notably fragmented body of literature. In this article, the authors describe the pause-and-reflect exercise they undertook during the execution of a synthesis of the literature on clinical reasoning in the health professions. Confronted with the challenge of establishing a shared understanding of the nature and relevant components of clinical reasoning, members of the review team paused to independently generate their own personal definitions and conceptualizations of the construct. Here, the authors describe the variability of definitions and conceptualizations of clinical reasoning present within their own team. Drawing on an analogy from mathematics, they hypothesize that the presence of differing "boundary conditions" could help explain individuals' differing conceptualizations of clinical reasoning and the fragmentation at play in the wider sphere of research on clinical reasoning. Specifically, boundary conditions refer to the practice of describing the conditions under which a given theory is expected to hold, or expected to have explanatory power. Given multiple theoretical frameworks, research methodologies, and assessment approaches contained within the clinical reasoning literature, different boundary conditions are likely at play. Open acknowledgment of different boundary conditions and explicit description of the conceptualization of clinical reasoning being adopted within a given study would improve research communication, support comprehensive approaches to teaching and assessing clinical reasoning, and perhaps encourage new collaborative partnerships among researchers who adopt different boundary conditions.Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a "work of the United States Government" for which copyright protection under Title 17 of

Multiple sclerosis, from referral to confirmed diagnosis: an audit of clinical practice.

LENUS (Irish Health Repository)

Kelly, S B

2012-02-01

BACKGROUND: The National Institute for Health and Clinical Excellence (NICE) guidelines recommend a timeline of 6 weeks from referral to neurology consultation and then 6 weeks to a diagnosis of multiple sclerosis (MS). OBJECTIVES: We audited the clinical management of all new outpatient referrals diagnosed with MS between January 2007 and May 2010. METHODS: We analysed the timelines from referral to first clinic visit, to MRI studies and lumbar puncture (LP) (if performed) and the overall interval from first visit to the time the diagnosis was given to the patient. RESULTS: Of the 119 diagnoses of MS\\/Clinically Isolated Syndrome (CIS), 93 (78%) were seen within 6 weeks of referral. MRI was performed before first visit in 61% and within 6 weeks in a further 27%. A lumbar puncture (LP) was performed in 83% of all patients and was done within 6 weeks in 78%. In total, 63 (53%) patients received their final diagnosis within 6 weeks of their first clinic visit, with 57 (48%) patients having their diagnosis delayed. The main rate-limiting steps were the availability of imaging and LP, and administrative issues. CONCLUSIONS: We conclude that, even with careful scheduling, it is difficult for a specialist service to obtain MRI scans and LP results so as to fulfil NICE guidelines within the optimal six-week period. An improved service would require MRI scans to be arranged before the first clinic visit in all patients with suspected MS.

Clinical results of definitive-dose (50 Gy/25 fractions) preoperative chemoradiotherapy for unresectable esophageal cancer

International Nuclear Information System (INIS)

Ishikawa, Kazuki; Nakamatsu, Kiyoshi; Shiraishi, Osamu; Yasuda, Takushi; Nishimura, Yasumasa

2015-01-01

The clinical results of definitive-dose preoperative chemoradiotherapy (CRT) of 50 Gy/25 fractions/5 weeks for unresectable esophageal cancer were analyzed. Inclusion criteria were unresectable esophageal squamous cell carcinoma with T4b or mediastinal lymph nodes invading to the trachea or aorta. Radiation therapy of 50 Gy/25 fractions/5 weeks was combined concurrently with two courses of FP therapy (CDDP 70 mg/m 2 + 5-FU 700 mg/m 2 /d x 5 days: day 1-5, day 29-33). Tumor response was evaluated 4 weeks after completion of RT. Subtotal esophagectomy was planned 6-8 weeks after RT. Thirty patients (26 male and 4 female) aged from 50-78 years (median 66) were enrolled between 2008 and 2011. The clinical stages according to the 7th edition of UICC were stages II/III/IV, 1/23/6; T1/2/3/4, 1/1/4/24; and N0/1/2/3, 3/25/1/1. All 30 patients completed RT of 50 Gy/ 25 fractions. Initial tumor responses were 21 patients with resectable disease, 7 with unresectable disease, and 2 with progressive disease. Subtotal esophagectomy was performed in 18 (60%) of the 30 patients. Pathological complete response was obtained in five (28%) patients. There were two patients with hospitalization death after surgery (11%). Six of the 7 patients who still had unresectable disease were treated with 1-3 courses of docetaxel, CDDP and 5-FU. Three patients treated without surgery showed long-term survival. The 3-year locoregional control rate and the 3-year overall survival rate for the 30 patients were 70 and 49%, respectively. Definitive-dose preoperative CRT was feasible, and is a promising treatment strategy for unresectable esophageal cancer. (author)

Perspectives of rural and remote primary healthcare services on the meaning and goals of clinical governance.

Science.gov (United States)

Kwedza, Ruyamuro K; Larkins, Sarah; Johnson, Julie K; Zwar, Nicholas

2017-10-01

Definitions of clinical governance are varied and there is no one agreed model. This paper explored the perspectives of rural and remote primary healthcare services, located in North Queensland, Australia, on the meaning and goals of clinical governance. The study followed an embedded multiple case study design with semi-structured interviews, document analysis and non-participant observation. Participants included clinicians, non-clinical support staff, managers and executives. Similarities and differences in the understanding of clinical governance between health centre and committee case studies were evident. Almost one-third of participants were unfamiliar with the term or were unsure of its meaning; alongside limited documentation of a definition. Although most cases linked the concept of clinical governance to key terms, many lacked a comprehensive understanding. Similarities between cases included viewing clinical governance as a management and administrative function. Differences included committee members' alignment of clinical governance with corporate governance and frontline staff associating clinical governance with staff safety. Document analysis offered further insight into these perspectives. Clinical governance is well-documented as an expected organisational requirement, including in rural and remote areas where geographic, workforce and demographic factors pose additional challenges to quality and safety. However, in reality, it is not clearly, similarly or comprehensively understood by all participants.

[Clinical judgment is a schema. Conceptual proposals and training perspectives.

Science.gov (United States)

Nagels, Marc

2017-06-01

Clinical judgment is a critical concept for the development of nursing and nursing education. Its theoretical origins are multiple and its definition is not yet consensus. The analysis of the scientific and professional literature shows heterogeneous and dispersed points of views, notably on the role of intuition, on its cognitive and metacognitive dimensions, and on its proximity to other concepts. Between professional stakes and epistemological constructions, clinical judgment is still an emerging concept.To overcome the obstacle and contribute to the theoretical effort, we will argue that clinical judgment must be analyzed as a schema. It presents all the characteristics : diagnosis and information necessary for reasoning, rational decision-making process, metacognitive control and evaluation of decision-making. Perspectives then open to better understand the nursing activity.In conclusion, recommendations for developing clinical judgment in training will be presented.

Diagnostic Consideration for Sinonasal Wegener's Granulomatosis Clinically Mistaken for Carcinoma

Science.gov (United States)

La Rosa, Cristina; Emmanuele, Carmela; Tranchina, Maria Grazia; Ippolito, Massimo; Cosentino, Sebastiano; Saita, Vincenzo; Fraggetta, Filippo

2013-01-01

We report a case of Wegener's granulomatosis clinically mistaken for carcinoma in a 21-year-old girl presenting with an ulcerated mass of the nasopharynx associated with enlarged laterocervical nodes. The lesion was clinically suspected as malignant on the basis of clinical and radiological findings (namely, computed tomography scan and positron emission tomography). However, multiple biopsies were not conclusive for malignancy showing histological change suggestive of Wegener's granulomatosis. A serum determination of cANCA supported the diagnosis of Wegener's granulomatosis. Clinical findings and image studies suggested an erroneous diagnosis of malignancy whereas a definitive diagnosis of Wegener's granulomatosis was achieved only after repeated biopsies thus leading to a correct therapeutic approach. The Wegener granulomatosis must be added to the list of the differential diagnoses of the masses of the nasopharynx associated with or without enlarged laterocervical nodes. PMID:24106630

What is the definition of sports-related concussion: a systematic review.

Science.gov (United States)

McCrory, Paul; Feddermann-Demont, Nina; Dvořák, Jiří; Cassidy, J David; McIntosh, Andrew; Vos, Pieter E; Echemendia, Ruben J; Meeuwisse, Willem; Tarnutzer, Alexander A

2017-06-01

Various definitions for concussion have been proposed, each having its strengths and weaknesses. We reviewed and compared current definitions and identified criteria necessary for an operational definition of sports-related concussion (SRC) in preparation of the 5th Concussion Consensus Conference (Berlin, Germany). We also assessed the role of biomechanical studies in informing an operational definition of SRC. This is a systematic literature review. Data sources include MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Clinical Trials and SPORT Discus (accessed 14 September 2016). Eligibility criteria were studies reporting (clinical) criteria for diagnosing SRC and studies containing SRC impact data. Out of 1601 articles screened, 36 studies were included (2.2%), 14 reported on criteria for SRC definitions and 22 on biomechanical aspects of concussions. Six different operational definitions focusing on clinical findings and their dynamics were identified. Biomechanical studies were obtained almost exclusively on American football players. Angular and linear head accelerations linked to clinically confirmed concussions demonstrated considerable individual variation. SRC is a traumatic brain injury that is defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces with several common features that help define its nature. Limitations identified include that the current criteria for diagnosing SRC are clinically oriented and that there is no gold/standard to assess their diagnostic properties. A future, more valid definition of SRC would better identify concussed players by demonstrating high predictive positive/negative values. Currently, the use of helmet-based systems to study the biomechanics of SRC is limited to few collision sports. New approaches need to be developed to provide objective markers for SRC. © Article author(s) (or their employer(s) unless otherwise

Reconceptualizing synergism and antagonism among multiple stressors

OpenAIRE

Piggott, Jeremy J; Townsend, Colin R; Matthaei, Christoph D

2015-01-01

The potential for complex synergistic or antagonistic interactions between multiple stressors presents one of the largest uncertainties when predicting ecological change but, despite common use of the terms in the scientific literature, a consensus on their operational definition is still lacking. The identification of synergism or antagonism is generally straightforward when stressors operate in the same direction, but if individual stressor effects oppose each other, the definition of syner...

What is the definition of sports-related concussion

DEFF Research Database (Denmark)

McCrory, Paul; Feddermann-Demont, Nina; Dvořák, Jiří

2017-01-01

OBJECTIVES: Various definitions for concussion have been proposed, each having its strengths and weaknesses. We reviewed and compared current definitions and identified criteria necessary for an operational definition of sports-related concussion (SRC) in preparation of the 5th Concussion Consensus...... Conference (Berlin, Germany). We also assessed the role of biomechanical studies in informing an operational definition of SRC. DESIGN: This is a systematic literature review. DATA SOURCES: Data sources include MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central...... (2.2%), 14 reported on criteria for SRC definitions and 22 on biomechanical aspects of concussions. Six different operational definitions focusing on clinical findings and their dynamics were identified. Biomechanical studies were obtained almost exclusively on American football players. Angular...

12 CFR 583.12 - Multiple savings and loan holding company.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Multiple savings and loan holding company. 583... DEFINITIONS FOR REGULATIONS AFFECTING SAVINGS AND LOAN HOLDING COMPANIES § 583.12 Multiple savings and loan holding company. The term multiple savings and loan holding company means any savings and loan holding...

Patient-physician discussions about costs: definitions and impact on cost conversation incidence estimates.

Science.gov (United States)

Hunter, Wynn G; Hesson, Ashley; Davis, J Kelly; Kirby, Christine; Williamson, Lillie D; Barnett, Jamison A; Ubel, Peter A

2016-03-31

Nearly one in three Americans are financially burdened by their medical expenses. To mitigate financial distress, experts recommend routine physician-patient cost conversations. However, the content and incidence of these conversations are unclear, and rigorous definitions are lacking. We sought to develop a novel set of cost conversation definitions, and determine the impact of definitional variation on cost conversation incidence in three clinical settings. Retrospective, mixed-methods analysis of transcribed dialogue from 1,755 outpatient encounters for routine clinical management of breast cancer, rheumatoid arthritis, and depression, occurring between 2010-2014. We developed cost conversation definitions using summative content analysis. Transcripts were evaluated independently by at least two members of our multi-disciplinary team to determine cost conversation incidence using each definition. Incidence estimates were compared using Pearson's Chi-Square Tests. Three cost conversation definitions emerged from our analysis: (a) Out-of-Pocket (OoP) Cost--discussion of the patient's OoP costs for a healthcare service; (b) Cost/Coverage--discussion of the patient's OoP costs or insurance coverage; (c) Cost of Illness- discussion of financial costs or insurance coverage related to health or healthcare. These definitions were hierarchical; OoP Cost was a subset of Cost/Coverage, which was a subset of Cost of Illness. In each clinical setting, we observed significant variation in the incidence of cost conversations when using different definitions; breast oncology: 16, 22, 24% of clinic visits contained cost conversation (OOP Cost, Cost/Coverage, Cost of Illness, respectively; P cost conversation varied significantly depending on the definition used. Our findings and proposed definitions may assist in retrospective interpretation and prospective design of investigations on this topic.

Multiple sclerosis masquerading as Alzheimer-type dementia: Clinical, radiological and pathological findings.

Science.gov (United States)

Tobin, W O; Popescu, B F; Lowe, V; Pirko, I; Parisi, J E; Kantarci, K; Fields, J A; Bruns, M B; Boeve, B F; Lucchinetti, C F

2016-04-01

We report a comprehensive clinical, radiological, neuropsychometric and pathological evaluation of a woman with a clinical diagnosis of AD dementia (ADem), but whose autopsy demonstrated widespread demyelination, without Alzheimer disease (AD) pathology. Initial neuropsychometric evaluation suggested amnestic mild cognitive impairment (aMCI). Serial magnetic resonance images (MRI) images demonstrated the rate of increase in her ventricular volume was comparable to that of 46 subjects with aMCI who progressed to ADem, without accumulating white matter disease. Myelin immunohistochemistry at autopsy demonstrated extensive cortical subpial demyelination. Subpial lesions involved the upper cortical layers, and often extended through the entire width of the cortex. Multiple sclerosis (MS) can cause severe cortical dysfunction and mimic ADem. Cortical demyelination is not well detected by standard imaging modalities and may not be detected on autopsy without myelin immunohistochemistry. © The Author(s), 2015.

Definition and Facts for Constipation

Science.gov (United States)

... Causes Diagnosis Treatment Eating, Diet, & Nutrition Clinical Trials Definition & Facts for Constipation What is constipation? Constipation is ... and Treatment. New York, NY: Springer Science and Business Media; 2014. May 2018 Share Previous: Constipation Next: ...

A Vietnamese man with selective mutism: the relevance of multiple interacting 'cultures' in clinical psychiatry.

Science.gov (United States)

Hollifield, Michael; Geppert, Cynthia; Johnson, Yuam; Fryer, Carol

2003-09-01

Multiple cultural variables have effects on the psychobiology and behavioral manifestations of illness, as do patient and physician perceptions of illness. The interaction among these variables is at the heart of clinical psychiatry. This case of a Vietnamese man with selective mutism underscores the relevance of the 'cultures' of medicine, psychiatry, and war and trauma on the manifestations of illness and illness perceptions by patient and physician. The discussion focuses on how these cultures interact and play a crucial role in formulating diagnosis and treatment planning. Suggestions are given for shifts in medical education that will encourage relevant cultural paradigms to make their way into educational and clinical systems, which in turn should improve cultural competence in clinical psychiatry.

TFOS DEWS II Definition and Classification Report.

Science.gov (United States)

Craig, Jennifer P; Nichols, Kelly K; Akpek, Esen K; Caffery, Barbara; Dua, Harminder S; Joo, Choun-Ki; Liu, Zuguo; Nelson, J Daniel; Nichols, Jason J; Tsubota, Kazuo; Stapleton, Fiona

2017-07-01

The goals of the TFOS DEWS II Definition and Classification Subcommittee were to create an evidence-based definition and a contemporary classification system for dry eye disease (DED). The new definition recognizes the multifactorial nature of dry eye as a disease where loss of homeostasis of the tear film is the central pathophysiological concept. Ocular symptoms, as a broader term that encompasses reports of discomfort or visual disturbance, feature in the definition and the key etiologies of tear film instability, hyperosmolarity, and ocular surface inflammation and damage were determined to be important for inclusion in the definition. In the light of new data, neurosensory abnormalities were also included in the definition for the first time. In the classification of DED, recent evidence supports a scheme based on the pathophysiology where aqueous deficient and evaporative dry eye exist as a continuum, such that elements of each are considered in diagnosis and management. Central to the scheme is a positive diagnosis of DED with signs and symptoms, and this is directed towards management to restore homeostasis. The scheme also allows consideration of various related manifestations, such as non-obvious disease involving ocular surface signs without related symptoms, including neurotrophic conditions where dysfunctional sensation exists, and cases where symptoms exist without demonstrable ocular surface signs, including neuropathic pain. This approach is not intended to override clinical assessment and judgment but should prove helpful in guiding clinical management and research. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical aspects of multiple pregnancy

NARCIS (Netherlands)

J.G. Santema

1996-01-01

textabstractThe natural wonder of multiple pregnancy and birth has fascinated mankind since ancient times and twins figure prominently in legends, folktales and myths. One of the best known traditional stories is that of Romulus and Remus, the twins who were abandoned on the banks of the Tiber and

Acute respiratory distress syndrome 40 years later: time to revisit its definition.

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Phua, Jason; Stewart, Thomas E; Ferguson, Niall D

2008-10-01

Acute respiratory distress syndrome is a common disorder associated with significant mortality and morbidity. The aim of this article is to critically evaluate the definition of acute respiratory distress syndrome and examine the impact the definition has on clinical practice and research. Articles from a MEDLINE search (1950 to August 2007) using the Medical Subject Heading respiratory distress syndrome, adult, diagnosis, limited to the English language and human subjects, their relevant bibliographies, and personal collections, were reviewed. The definition of acute respiratory distress syndrome is important to researchers, clinicians, and administrators alike. It has evolved significantly over the last 40 years, culminating in the American-European Consensus Conference definition, which was published in 1994. Although the American-European Consensus Conference definition is widely used, it has some important limitations that may impact on the conduct of clinical research, on resource allocation, and ultimately on the bedside management of such patients. These limitations stem partially from the fact that as defined, acute respiratory distress syndrome is a heterogeneous entity and also involve the reliability and validity of the criteria used in the definition. This article critically evaluates the American-European Consensus Conference definition and its limitations. Importantly, it highlights how these limitations may contribute to clinical trials that have failed to detect a potential true treatment effect. Finally, recommendations are made that could be considered in future definition modifications with an emphasis on the significance of accurately identifying the target population in future trials and subsequently in clinical care. How acute respiratory distress syndrome is defined has a significant impact on the results of randomized, controlled trials and epidemiologic studies. Changes to the current American-European Consensus Conference definition are

Clinical cardiac positron emission tomography: State of the art

International Nuclear Information System (INIS)

Gould, K.L.

1991-01-01

Cardiac positron emission tomography (PET) has evolved rapidly from a relatively esoteric research tool into clinical applications providing unique, quantitative information on myocardial perfusion, metabolism, and cell membrane function and having a potentially significant impact on cardiovascular medicine. Although there are many different positron radionuclides for imaging diverse myocardial behavior, three radionuclides have reached accepted clinical utility. Cardiac PET using nitrogen-13-ammonia, rubidium-82, and fluoro-18-deoxyglucose has proved accurate and definitive in multiple university and private-practice sites for diagnosing and assessing severity and location of coronary artery disease in symptomatic or asymptomatic patients, for identifying injured but viable myocardium potentially salvageable by revascularization, and for ruling out clinically significant coronary artery stenosis with a high specificity in patients who might otherwise undergo coronary arteriography to document the absence of significant disease. 89 references

Proposing a Novel, Three-level Definition of Periodontitis 
using Probing Depth, Clinical Attachment Loss and Bleeding on Probing: Analysis of a Rural Chinese Population.

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Pei, Xi Yan; He, Lu; Ouyang, Xiang Ying

To propose a novel, three-level (severe, moderate, mild) case definition using probing depth (PD), clinical attachment loss (CAL) and bleeding on probing (BOP) for epidemiologic studies on periodontitis. Case definitions (DEF) 1-30 with PD, CAL and BOP were made. Based on data from epidemiologic research in Chengde (Hebei Province, China) in 1992, prevalence of periodontitis by DEF1-30 was calculated and compared with a reference (definitions by Centers for Disease Control and Prevention/American Academy of Periodontology in 2012). Sensitivity, specificity, Youden Index, Cohen's kappa coefficient (CKC) and the area under the receiver operator characteristic curve (AUC) were calculated for the definitions selected. DEF1 and DEF18 for periodontitis, DEF2, DEF3, DEF19 for moderate and severe periodontitis, and DEF5, DEF13, DEF14, DEF21 and DEF25 for severe periodontitis, which were similar for estimation of periodontitis prevalence compared with the reference, were selected. DEF18 for periodontitis, DEF19 for moderate and severe periodontitis, and DEF5 for severe periodontitis were selected because they showed higher values for the Youden Index, CKC and AUC, and formed a three-level definition. A novel three-level case classification of periodontitis using three parameters of PD, CAL and BOP was proposed. The estimated periodontitis prevalence according to the novel proposed definition is close to the prevalence according to the CDC/AAP definition.

Defining progression in nonmuscle invasive bladder cancer: it is time for a new, standard definition.

Science.gov (United States)

Lamm, Donald; Persad, Raj; Brausi, Maurizio; Buckley, Roger; Witjes, J Alfred; Palou, Joan; Böhle, Andreas; Kamat, Ashish M; Colombel, Marc; Soloway, Mark

2014-01-01

Despite being one of the most important clinical outcomes in nonmuscle invasive bladder cancer, there is currently no standard definition of disease progression. Major clinical trials and meta-analyses have used varying definitions or have failed to define this end point altogether. A standard definition of nonmuscle invasive bladder cancer progression as determined by reproducible and reliable procedures is needed. We examine current definitions of nonmuscle invasive bladder cancer progression, and propose a new definition that will be more clinically useful in determining patient prognosis and comparing treatment options. The IBCG (International Bladder Cancer Group) analyzed published clinical trials and meta-analyses that examined nonmuscle invasive bladder cancer progression as of December 2012. The limitations of the definitions of progression used in these trials were considered, as were additional parameters associated with the advancement of nonmuscle invasive bladder cancer. The most commonly used definition of nonmuscle invasive bladder cancer progression is an increase in stage from nonmuscle invasive to muscle invasive disease. Although this definition is clinically important, it fails to include other important parameters of advancing disease such as progression to lamina propria invasion and increase in grade. The IBCG proposes the definition of nonmuscle invasive bladder cancer progression as an increase in T stage from CIS or Ta to T1 (lamina propria invasion), development of T2 or greater or lymph node (N+) disease or distant metastasis (M1), or an increase in grade from low to high. Investigators should consider the use of this new definition to help standardize protocols and improve the reporting of progression. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Volume definition system for treatment planning

International Nuclear Information System (INIS)

Alakuijala, Jyrki; Pekkarinen, Ari; Puurunen, Harri

1997-01-01

Purpose: Volume definition is a difficult and time consuming task in 3D treatment planning. We have studied a systems approach for constructing an efficient and reliable set of tools for volume definition. Our intent is to automate body outline, air cavities and bone volume definition and accelerate definition of other anatomical structures. An additional focus is on assisting in definition of CTV and PTV. The primary goals of this work are to cut down the time used in contouring and to improve the accuracy of volume definition. Methods: We used the following tool categories: manual, semi-automatic, automatic, structure management, target volume definition, and visualization tools. The manual tools include mouse contouring tools with contour editing possibilities and painting tools with a scaleable circular brush and an intelligent brush. The intelligent brush adapts its shape to CT value boundaries. The semi-automatic tools consist of edge point chaining, classical 3D region growing of single segment and competitive volume growing of multiple segments. We tuned the volume growing function to take into account both local and global region image values, local volume homogeneity, and distance. Heuristic seeding followed with competitive volume growing finds the body outline, couch and air automatically. The structure management tool stores ICD-O coded structures in a database. The codes have predefined volume growing parameters and thus are able to accommodate the volume growing dissimilarity function for different volume types. The target definition tools include elliptical 3D automargin for CTV to PTV transformation and target volume interpolation and extrapolation by distance transform. Both the CTV and the PTV can overlap with anatomical structures. Visualization tools show the volumes as contours or color wash overlaid on an image and displays voxel rendering or translucent triangle mesh rendering in 3D. Results: The competitive volume growing speeds up the

Validation of the Telephone Interview of Cognitive Status and Telephone Montreal Cognitive Assessment Against Detailed Cognitive Testing and Clinical Diagnosis of Mild Cognitive Impairment After Stroke.

Science.gov (United States)

Zietemann, Vera; Kopczak, Anna; Müller, Claudia; Wollenweber, Frank Arne; Dichgans, Martin

2017-11-01

Assessment of cognitive status poststroke is recommended by guidelines but follow-up can often not be done in person. The Telephone Interview of Cognitive Status (TICS) and the Telephone Montreal Cognitive Assessment (T-MoCA) are considered useful screening instruments. Yet, evidence to define optimal cut-offs for mild cognitive impairment (MCI) after stroke is limited. We studied 105 patients enrolled in the prospective DEDEMAS study (Determinants of Dementia After Stroke; NCT01334749). Follow-up visits at 6, 12, 36, and 60 months included comprehensive neuropsychological testing and the Clinical Dementia Rating scale, both of which served as reference standards. The original TICS and T-MoCA were obtained in 2 separate telephone interviews each separated from the personal visits by 1 week (1 before and 1 after the visit) with the order of interviews (TICS versus T-MoCA) alternating between subjects. Area under the receiver-operating characteristic curves was determined. Ninety-six patients completed both the face-to-face visits and the 2 interviews. Area under the receiver-operating characteristic curves ranged between 0.76 and 0.83 for TICS and between 0.73 and 0.94 for T-MoCA depending on MCI definition. For multidomain MCI defined by multiple-tests definition derived from comprehensive neuropsychological testing optimal sensitivities and specificities were achieved at cut-offs <36 (TICS) and <18 (T-MoCA). Validity was lower using single-test definition, and cut-offs were higher compared with multiple-test definitions. Using Clinical Dementia Rating as the reference, optimal cut-offs for MCI were <36 (TICS) and approximately 19 (T-MoCA). Both the TICS and T-MoCA are valid screening tools poststroke, particularly for multidomain MCI using multiple-test definition. © 2017 American Heart Association, Inc.

Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis

Directory of Open Access Journals (Sweden)

Gajofatto A

2015-12-01

Full Text Available Alberto Gajofatto,1,2 Marco Turatti,2 Salvatore Monaco,1,2 Maria Donata Benedetti2 1Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy; 2Division of Neurology B, Verona University Hospital, Verona, Italy Abstract: Fingolimod is a selective immunosuppressive agent approved worldwide for the treatment of relapsing-remitting multiple sclerosis (MS, a chronic and potentially disabling neurological condition. Randomized double-blind clinical trials have shown that fingolimod significantly reduces relapse rate and ameliorates a number of brain MRI measures, including cerebral atrophy, compared to both placebo and intramuscular interferon-1a. The effect on disability progression remains controversial, since one Phase III trial showed a significant benefit of treatment while two others did not. Although fingolimod has a very convenient daily oral dosing, the possibility of serious cardiac, ocular, infectious, and other rare adverse events justified the decision of the European Medicines Agency to approve the drug as a second-line treatment for MS patients not responsive to first-line therapy, or those with rapidly evolving course. In the United States, fingolimod is instead authorized as a first-line treatment. The aim of this review is to describe and discuss the characteristics of fingolimod concerning its efficacy, safety, and tolerability in the clinical context of multiple sclerosis management. Keywords: multiple sclerosis, fingolimod, safety, tolerability, efficacy

The diagnosis of multiple sclerosis

International Nuclear Information System (INIS)

Sanders, E.A.C.M.

1982-01-01

This thesis describes recently developed research methods for the diagnosis of multiple sclerosis. In Chapter X the use of the CT-scan in the detection of hemispheral or cerebellar lesions is discussed. In chapter XIII the results of the application of all methods to a group of 89 patients with definite, probable or possible multiple sclerosis and to a group of 25 purely optic neuritis patients are presented. With the aid of the CT-scan, hypo- or hyperdense areas in the white matter of the cerebral hemispheres were found in 52% of the 114 patients. Most reports ascribe these lesions to demyelinating cerebral plaques. The CT-scan showed no cerebellar or brainstem lesions. The CT-scan is independent of the duration of, and degree of incapacitation due to, the disease and can be helpful in giving a definite diagnosis in an early stage of the disease. The CT-scan will always play an important role for the differential diagnosis. (Auth.)

Evaluation of the 2010 McDonald multiple sclerosis criteria in children with a clinically isolated syndrome.

Science.gov (United States)

Kornek, Barbara; Schmitl, Beate; Vass, Karl; Zehetmayer, Sonja; Pritsch, Martin; Penzien, Johann; Karenfort, Michael; Blaschek, Astrid; Seidl, Rainer; Prayer, Daniela; Rostasy, Kevin

2012-12-01

Magnetic resonance imaging diagnostic criteria for paediatric multiple sclerosis have been established on the basis of brain imaging findings alone. The 2010 McDonald criteria for the diagnosis of multiple sclerosis, however, include spinal cord imaging for detection of lesion dissemination in space. The new criteria have been recommended in paediatric multiple sclerosis. (1) To evaluate the 2010 McDonald multiple sclerosis criteria in children with a clinically isolated syndrome and to compare them with recently proposed magnetic resonance criteria for children; (2) to assess whether the inclusion of spinal cord imaging provided additional value to the 2010 McDonald criteria. We performed a retrospective analysis of brain and spinal cord magnetic resonance imaging scans from 52 children with a clinically isolated syndrome. Sensitivity, specificity and accuracy of the magnetic resonance criteria were assessed. The 2010 McDonald dissemination in space criteria were more sensitive (85% versus 74%) but less specific (80% versus 100%) compared to the 2005 McDonald criteria. The Callen criteria were more accurate (89%) compared to the 2010 McDonald (85%), the 2005 McDonald criteria for dissemination in space (81%), the KIDMUS criteria (46%) and the Canadian Pediatric Demyelinating Disease Network criteria (76%). The 2010 McDonald criteria for dissemination in time were more accurate (93%) than the dissemination in space criteria (85%). Inclusion of the spinal cord did not increase the accuracy of the McDonald criteria.

The Importance of Clinical Phenotype in Understanding and Preventing Spontaneous Preterm Birth.

Science.gov (United States)

Esplin, M Sean

2016-02-01

Spontaneous preterm birth (SPTB) is a well-known cause of maternal and neonatal morbidity. The search for the underlying pathways, documentation of the genetic causes, and identification of markers of spontaneous PTB have been marginally successful due to the fact that it is highly complex, with numerous processes that lead to a final common pathway. There is a great need for a comprehensive, consistent, and uniform classification system, which will be useful in identifying mechanisms, assigning prognosis, aiding in clinical management, and can identify areas of interest for intervention and future study. Effective classification systems must overcome obstacles including the lack of widely accepted definitions and uncertainty about inclusion of classifying features (e.g., presentation at delivery and multiple gestations) and levels of detail of these features. The optimal classification system should be based on the clinical phenotype, including characteristics of the mother, fetus, placenta, and the presentation for delivery. We present a proposed phenotyping system for spontaneous PTB. Future classification systems must establish a universally accepted set of definitions and a standardized clinical workup for all PTBs including the minimum clinical data to be collected and the laboratory and pathologic evaluation that should be completed. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Aggressive periodontitis: case definition and diagnostic criteria.

Science.gov (United States)

Albandar, Jasim M

2014-06-01

Aggressive periodontitis is a destructive disease characterized by the following: the involvement of multiple teeth with a distinctive pattern of periodontal tissue loss; a high rate of disease progression; an early age of onset; and the absence of systemic diseases. In some patients periodontal tissue loss may commence before puberty, whereas in most patients the age of onset is during or somewhat after the circumpubertal period. Besides infection with specific microorganisms, a host predisposition seems to play a key role in the pathogenesis of aggressive periodontitis, as evidenced by the familial aggregation of the disease. In this article we review the historical background of the diagnostic criteria of aggressive periodontitis, present a contemporary case definition and describe the clinical parameters of the disease. At present, the diagnosis of aggressive periodontitis is achieved using case history, clinical examination and radiographic evaluation. The data gathered using these methods are prone to relatively high measurement errors. Besides, this diagnostic approach measures past disease history and may not reliably measure existing disease activity or accurately predict future tissue loss. A diagnosis is often made years after the onset of the disease, partly because current assessment methods detect established disease more readily and reliably than they detect incipient or initial lesions where the tissue loss is minimal and usually below the detection threshold of present examination methods. Future advancements in understanding the pathogenesis of this disease may contribute to an earlier diagnosis. Insofar, future case definitions may involve the identification of key etiologic and risk factors, combined with high-precision methodologies that enable the early detection of initial lesions. This may significantly enhance the predictive value of these tests and detect cases of aggressive periodontitis before significant tissue loss develops. © 2014

Microsatellite typing of clinical and environmental Cryptococcus neoformans var. grubii isolates from Cuba shows multiple genetic lineages.

Directory of Open Access Journals (Sweden)

Maria-Teresa Illnait-Zaragozi

Full Text Available BACKGROUND: Human cryptococcal infections have been associated with bird droppings as a likely source of infection. Studies toward the local and global epidemiology of Cryptococcus spp. have been hampered by the lack of rapid, discriminatory, and exchangeable molecular typing methods. METHODOLOGY/PRINCIPAL FINDINGS: We selected nine microsatellite markers for high-resolution fingerprinting from the genome of C. neoformans var. grubii. This panel of markers was applied to a collection of clinical (n = 122 and environmental (n = 68; from pigeon guano C. neoformans var. grubii isolates from Cuba. All markers proved to be polymorphic. The average number of alleles per marker was 9 (range 5-51. A total of 104 genotypes could be distinguished. The discriminatory power of this panel of markers was 0.993. Multiple clusters of related genotypes could be discriminated that differed in only one or two microsatellite markers. These clusters were assigned as microsatellite complexes. The majority of environmental isolates (>70% fell into 1 microsatellite complex containing only few clinical isolates (49 environmental versus 2 clinical. Clinical isolates were segregated over multiple microsatellite complexes. CONCLUSIONS/SIGNIFICANCE: A large genotypic variation exists in C. neoformans var. grubii. The genotypic segregation between clinical and environmental isolates from pigeon guano suggests additional source(s of human cryptococcal infections. The selected panel of microsatellite markers is an excellent tool to study the epidemiology of C. neoformans var. grubii.

Clinically significant cardiopulmonary events and the effect of definition standardization on apnea of prematurity management.

Science.gov (United States)

Powell, M B F; Ahlers-Schmidt, C R; Engel, M; Bloom, B T

2017-01-01

To define the impact of care standardization on caffeine and cardiorespiratory monitoring at neonatal intensive care unit (NICU) discharge. Electronic records were abstracted for infants aged 24-36 weeks gestation with birth weights appropriate for gestational age. Infants who died, transferred prior to discharge, had major pulmonary anomalies, required a home monitor for mechanical ventilation or had a family history of sudden infant death syndrome were excluded. Data and records were used to indicate when the new definition of clinically significant cardiopulmonary events (CSCPEs) and concurrent education was implemented. Preimplementation and postimplementation cohorts were compared. Incidence fell from 74% diagnosed with apnea of prematurity at baseline to 49% diagnosed with CSCPE postimplementation (Pdefinitions and treatments reduced the use of caffeine and cardiorespiratory monitors upon NICU dismissal.

Magnetic resonance imaging in optic nerve lesions with multiple sclerosis

International Nuclear Information System (INIS)

Kojima, Shigeyuki; Hirayama, Keizo; Kakisu, Yonetsugu; Adachi, Emiko

1990-01-01

Magnetic resonance imaging (MRI) of the optic nerve was performed in 10 patients with multiple sclerosis (MS) using short inversion time inversion recovery (STIR) pulse sequences, and the results were compared with the visual evoked potentials (VEP). The 10 patients had optic neuritis in the chronic or remitting phase together with additional symptoms or signs allowing a diagnosis of clinically definite or probable MS. Sixteen optic nerves were clinically affected and 4 were unaffected. MRI was performed using a 0.5 tesla supeconducting unit, and multiple continuous 5 mm coronal and axial STIR images were obtained. A lesion was judged to be present if a focal or diffuse area of increased signal intensity was detectd in the optic nerve. In VEP, a delay in peak latency or no P 100 component was judged to be abnormal. With regard to the clinically affected optic nerves, MRI revealed a region of increased signal intensity in 14/16 (88%) and the VEP was abnormal in 16/16 (100%). In the clinically unaffected optic nerves, MRI revealed an increased signal intensity in 2/4 (50%). One of these nerves had an abnormal VEP and the other had a VEP latency at the upper limit of normal. The VEP was abnormal in 1/4 (25%). In the clinically affected optic nerves, the degree of loss of visual acuity was not associated with the longitudinal extent of the lesions shown by MRI. The mean length was 17.5 mm in optic nerves with a slight disturbance of visual acuity and 15.0 mm in nerves with severe visual loss. MRI using STIR pulse sequences was found to be almost as sensitive as VEP in detecting both clinically affected and unaffected optic nerve lesions in patients with MS, and was useful in visualizing the location or size of the lesions. (author)

Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

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Elskamp, I.J. van den; Boden, B.; Barkhof, F. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); Dattola, V. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); University of Messina, Department of Neurosciences, Psychiatric and Anaesthesiological Sciences, Messina (Italy); Knol, D.L. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); Filippi, M. [Scientific Institute and University Ospedale San Raffaele, Neuroimaging Research Unit, Milan (Italy); Kappos, L. [University Hospital, University of Basel, Department of Neurology, Basel (Switzerland); Fazekas, F. [Medical University of Graz, Department of Neurology, Graz (Austria); Wagner, K. [Bayer-Schering Pharma, Berlin (Germany); Pohl, C. [Bayer-Schering Pharma, Berlin (Germany); University Hospital Bonn, Department of Neurology, Bonn (Germany); Sandbrink, R. [Bayer-Schering Pharma, Berlin (Germany); Heinrich-Heine-University Dusseldorf, Department of Neurology, Dusseldorf (Germany); Polman, C.H. [VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands); Uitdehaag, B.M.J. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands)

2010-10-15

Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. A significant atrophy occurred over 6 months (PBVC = -0.33%, SE = 0.061, p < 0.0001). The number of baseline T2 lesions (p = 0.024), the on-study Gd-enhancing lesion volume (p = 0.044), and the number of on-study PBHs (p = 0.003) were associated with an increased rate of atrophy. For a 50% decrease in rate of atrophy, the sample size calculations showed that approximately 283 patients per arm are required in an unselected sampled population and 185 patients per arm are required in a selected population. Within a 6-month period, significant atrophy can be detected and on-study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism. Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power. (orig.)

[Ethics in clinical research: contextualizing and reductionist problem definitions, forms of ethical reflection and some particular implications].

Science.gov (United States)

Roelcke, Volker

2003-12-01

The present paper starts off with a short outline of issues, conflicts, and goals of ethical reflection about clinical research. It is then argued that non-reductionist, patient-centred ethics should critically reflect on medically preformed problem definitions, ways of problem solution, and evaluations. The shortcomings of such preformed perceptions and interpretations are illustrated using the examples of dementia research, and the complexities of the notion of risk. A more comprehensive approach including the perceptions, interpretations, and evaluations of the patients' perspective necessitates a form of ethical reflection which takes into account the social and cultural contexts of clinical research, and which therefore relies on concepts and methods of the cultural sciences (in particular history, sociology, and cultural anthropology). The decision for a reductionist, or for a contextualising mode of ethical reflection represents in itself a value decision and needs to be explicitly justified.

Combined embolization with multiple materials for the treatment of esophagogastric varices: an analysis of clinical therapeutic effect

International Nuclear Information System (INIS)

Lu Yanping; Qin Haopu; Zhang Mengzeng

2011-01-01

Objective: To evaluate the clinical efficacy of percutaneous transhepatic combined embolization with multiple materials in treating esophagogastric varices. Methods: A total of 48 patients with esophagogastric varices complicated by bleeding due to ruptured varices were enrolled in this study. Percutaneous transhepatic combined embolization with Gelfoam, ethanol and stainless steel coils was carried out in all patients. The clinical results were analyzed. Results: Superselective catheterization and subsequent combined embolization procedure were successfully completed in all patients. In 17 patients with acute upper gastrointestinal bleeding, one died seven days after the treatment because of general failure. Postoperative gastroscopic examination was performed in 33 patients, which showed that esophagogastric varices were completely obliterated in 27 patients and markedly improved in six patients. A total of 35 patients were followed up for 4-36 months. During the follow-up period rebleeding occurred in 5 and death in 2 patients. Conclusion: For the treatment of esophagogastric varices, combined embolization with multiple materials is mini-invasive, safe and effective. It is of value to popularize this technique in clinical practice. (authors)

Familial risks of breast and prostate cancers: does the definition of the at risk period matter?

Science.gov (United States)

Brandt, Andreas; Bermejo, Justo Lorenzo; Sundquist, Jan; Hemminki, Kari

2010-03-01

'Being at familial risk' may have different connotations in studies on familial risk of cancer. The register-based definition of a family history considers individuals with an affected relative at familial risk independently of the family member's diagnostic time. Alternatively, the individuals are classified to be at familial risk only after the diagnosis date of their relative, relevant to clinical counselling and screening situations. The aim of this study was to compare familial breast and prostate cancer risks according to the two definitions. The nationwide Swedish Family-Cancer Database with information on cancers from 1958 to 2006 was used to calculate the hazard ratio of breast and prostate cancers according to family history using Cox regression. Family history was defined considering the number and type of affected relatives and the relative's diagnostic age, respectively. Individuals were considered at familial risk from their entry to the study or, alternatively, from the diagnostic time of the relative. Hazard ratios were equal whether individuals were considered at risk independent of the relative's diagnostic date or only after the relative's diagnostic date. These results indicate that studies on familial breast or prostate cancer risk which do not take the relative's diagnosis date into account are applicable to screening and clinical counselling situations. The estimates according to the register-based definition are based on larger numbers of patients, which may be crucial for analysis of small groups such as families of multiple cases. Copyright 2009 Elsevier Ltd. All rights reserved.

Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies Proposal of a Multidisciplinary Research Group

NARCIS (Netherlands)

Vergouwen, Mervyn D. I.; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J. E.; Wijdicks, Eelco F.; Muizelaar, J. Paul; Mendelow, A. David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G.; Macdonald, R. Loch; Diringer, Michael N.; Broderick, Joseph P.; Dreier, Jens P.; Roos, Yvo B. W. E. M.

2010-01-01

Background and Purpose-In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of

Case definition for progressive multifocal leukoencephalopathy following treatment with monoclonal antibodies.

Science.gov (United States)

Mentzer, Dirk; Prestel, Jürgen; Adams, Ortwin; Gold, Ralf; Hartung, Hans-Peter; Hengel, Hartmut; Kieseier, Bernd C; Ludwig, Wolf-Dieter; Keller-Stanislawski, Brigitte

2012-09-01

Novel immunosuppressive/modulating therapies with monoclonal antibodies (MABs) have been associated with progressive multifocal leukoencephalopathy (PML), a potentially fatal disease of the brain caused by the JC virus. Taking the complex diagnostic testing and heterogeneous clinical presentation of PML into account, an agreed case definition for PML is a prerequisite for a thorough assessment of PML. A working group was established to develop a standardised case definition for PML which permits data comparability across clinical trials, postauthorisation safety studies and passive postmarketing surveillance. The case definition is designed to define levels of diagnostic certainty of reported PML cases following treatment with MABs. It was subsequently used to categorise retrospectively suspected PML cases from Germany reported to the Paul-Ehrlich-Institute as the responsible national competent authority. The algorithm of the case definition is based on clinical symptoms, PCR for JC virus DNA in cerebrospinal fluid, brain MRI, and brain biopsy/autopsy. The case definition was applied to 119 suspected cases of PML following treatment with MABs and is considered to be helpful for case ascertainment of suspected PML cases for various MABs covering a broad spectrum of indications. Even if the available information is not yet complete, the case definition provides a level of diagnostic certainty. The proposed case definition permits data comparability among different medicinal products and among active as well as passive surveillance settings. It may form a basis for meaningful risk analysis and communication for regulators and healthcare professionals.

The correlation between the ASTRO consensus panel definition of biochemical failure and clinical outcome for patients with prostate cancer treated with external beam irradiation

International Nuclear Information System (INIS)

Horwitz, Eric M.; Vicini, Frank A.; Ziaja, Ellen L.; Dmuchowski, Carl F.; Stromberg, Jannifer S.; Martinez, Alvaro A.

1998-01-01

Purpose: We reviewed our institution's experience treating patients with external beam irradiation (RT) to determine if the ASTRO Consensus Panel definition of biochemical failure (BF) following radiation therapy correlates with clinical distant metastases free survival (DMFS), disease-free survival (DFS), cause-specific survival (CSS), and local control (LC). Methods and Materials: Between 1/1/87 and 12/31/92, 568 patients with clinically localized prostate cancer received external beam irradiation (RT) using localized prostate fields at William Beaumont Hospital (median total dose 66.6 Gy; range: 60-70.4 Gy). Biochemical failure was defined as three consecutive increases in post-treatment prostate specific antigen (PSA) after achieving a nadir. Biochemical failure was recorded as the time midway between the nadir and the first rising PSA. Five-year actuarial rates of clinical DMFS, DFS, CSS, and LC were calculated for patients who were biochemically controlled (BC) versus those who failed biochemically. Median follow-up was 56 months (range: 24-118 months). Results: Five-year actuarial rates of DMFS, DFS, CSS, and LC were significantly greater in patients who were biochemically controlled versus those who were not (p < 0.001). In patients who were BC, the 5-year actuarial rates of DMFS, DFS, CSS, and LC were 99%, 99%, 98%, and 99% respectively. For patients who failed biochemically, the 5-year actuarial rates of DMFS, DFS, CSS, and LC were 74%, 64%, 89%, and 86% respectively. When stratifying by pretreatment PSA, Gleason score, and T stage these differences remained significant for DMFS, DFS, and CSS. The Cox proportional hazards model demonstrated that BC was the single most important predictor of clinical outcome for DMFS, DFS, CSS, and LC. Pretreatment PSA and Gleason score were also independent predictors of outcome for DMFS and DFS. Conclusions: The ASTRO Consensus Panel definition of BF following radiation therapy correlates well with clinical DMFS, DFS

Issues in the definition and diagnosis of alcoholism: implications for a reformulation.

Science.gov (United States)

Babor, T F; Kranzler, H R; Kadden, R M

1986-01-01

This paper examines definitions of alcoholism from theoretical and historical points of view. It begins with a review of definitions of alcoholism from the 19th century to the present, giving particular attention to medical approaches, psychiatric formulations, behavioral concepts, and definitions proposed by the American Psychiatric Association and the World Health Organization. It is concluded that current definitions differ widely in scope, the meanings attached to words like disease and disorder, the criteria for including signs and symptoms as essential characteristics, and the potential uses of the definitions. Based on these considerations, the practical issues of developing and applying clinically useful diagnostic procedures are discussed. The paper concludes with a discussion of diagnostic issues that should be considered in any effort to improve clinical identification, treatment planning and international communication.

Multiple sclerosis with predominant, severe cognitive impairment

Science.gov (United States)

Staff, Nathan P.; Lucchinetti, Claudia F.; Keegan, B. Mark

2009-01-01

Objective To describe the characteristics of multiple sclerosis (MS) presenting with severe cognitive impairment as its primary disabling manifestation. Design Retrospective case series. Setting Tertiary referral center. Patients Patients were identified through the Mayo Clinic data retrieval system (1996–2008) with definite MS (McDonald criteria) and severe cognitive impairment as their primary neurological symptom without accompanying significant MS-related impairment or alternative diagnosis for cognitive dysfunction. Twenty-three patients meeting inclusion criteria were compared regarding demographics, clinical course and radiological features. Main Outcome Measures Demographic, clinical, and radiological characteristics of the disease. Results Twelve patients were men. The median age of the first clinical symptom suggestive of CNS demyelination was 33 years, and severe MS-related cognitive impairment developed at a median of 39 years. Cognitive impairment could be dichotomized as subacute fulminant (n=9) or chronic progressive (n=14) in presentation, which corresponded to subsequent relapsing or progressive MS courses. Study patients commonly exhibited psychiatric (65%), mild cerebellar (57%) and cortical symptoms and signs (e.g. seizure, aphasia, apraxia) (39%). Fourteen of 21 (67%), where documented, smoked cigarettes. Brain MRI demonstrated diffuse cerebral atrophy in 16 and gadolinium enhancing lesions in 11. Asymptomatic spinal cord MRI lesions were present in 12 of 16 patients (75%). Immunomodulatory therapies were generally ineffective in improving these patients. Conclusions We describe patients with MS whose clinical phenotype is characterized by severe cognitive dysfunction and prominent cortical and psychiatric signs presenting as a subacute fulminant or chronic progressive clinical course. Cigarette smokers may be over represented in this phenotype. PMID:19752304

Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium.

Science.gov (United States)

Rup, B; Pallardy, M; Sikkema, D; Albert, T; Allez, M; Broet, P; Carini, C; Creeke, P; Davidson, J; De Vries, N; Finco, D; Fogdell-Hahn, A; Havrdova, E; Hincelin-Mery, A; C Holland, M; H Jensen, P E; Jury, E C; Kirby, H; Kramer, D; Lacroix-Desmazes, S; Legrand, J; Maggi, E; Maillère, B; Mariette, X; Mauri, C; Mikol, V; Mulleman, D; Oldenburg, J; Paintaud, G; R Pedersen, C; Ruperto, N; Seitz, R; Spindeldreher, S; Deisenhammer, F

2015-09-01

Biopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted immunogenic responses to BPs, in particular those affecting clinical safety or efficacy, remain among the most common negative effects associated with this important class of drugs. To manage and reduce risk of unwanted immunogenicity, diverse communities of clinicians, pharmaceutical industry and academic scientists are involved in: interpretation and management of clinical and biological outcomes of BP immunogenicity, improvement of methods for describing, predicting and mitigating immunogenicity risk and elucidation of underlying causes. Collaboration and alignment of efforts across these communities is made difficult due to lack of agreement on concepts, practices and standardized terms and definitions related to immunogenicity. The Innovative Medicines Initiative (IMI; www.imi-europe.org), ABIRISK consortium [Anti-Biopharmaceutical (BP) Immunization Prediction and Clinical Relevance to Reduce the Risk; www.abirisk.eu] was formed by leading clinicians, academic scientists and EFPIA (European Federation of Pharmaceutical Industries and Associations) members to elucidate underlying causes, improve methods for immunogenicity prediction and mitigation and establish common definitions around terms and concepts related to immunogenicity. These efforts are expected to facilitate broader collaborations and lead to new guidelines for managing immunogenicity. To support alignment, an overview of concepts behind the set of key terms and definitions adopted to date by ABIRISK is provided herein along with a link to access and download the ABIRISK terms and definitions and provide comments (http://www.abirisk.eu/index_t_and_d.asp). © 2015 British Society for Immunology.

Infection by rhinovirus: similarity of clinical signs included in the case definition of influenza IAn/H1N1.

Science.gov (United States)

de Oña Navarro, Maria; Melón García, Santiago; Alvarez-Argüelles, Marta; Fernández-Verdugo, Ana; Boga Riveiro, Jose Antonio

2012-08-01

Although new influenza virus (IAn/H1N1) infections are mild and indistinguishable from any other seasonal influenza virus infections, there are few data on comparisons of the clinical features of infection with (IAn/H1N1) and with other respiratory viruses. The incidence, clinical aspects and temporal distribution of those respiratory viruses circulating during flu pandemic period were studied. Respiratory samples from patients with acute influenza-like symptoms were collected from May 2009 to December 2009. Respiratory viruses were detected by conventional culture methods and genome amplification techniques. Although IAn/H1N1 was the virus most frequently detected, several other respiratory viruses co-circulated with IAn/H1N1 during the pandemic period, especially rhinovirus. The similarity between clinical signs included in the clinical case definition for influenza and those caused by other respiratory viruses, particularly rhinovirus, suggest that a high percentage of viral infections were clinically diagnosed as case of influenza. Our study offers useful information to face future pandemics caused by influenza virus, indicating that differential diagnoses are required in order to not overestimate the importance of the pandemic. Copyright © 2011 Elsevier España, S.L. All rights reserved.

Developing a comprehensive definition of sustainability.

Science.gov (United States)

Moore, Julia E; Mascarenhas, Alekhya; Bain, Julie; Straus, Sharon E

2017-09-02

Understanding sustainability is one of the significant implementation science challenges. One of the big challenges in researching sustainability is the lack of consistent definitions in the literature. Most implementation studies do not present a definition of sustainability, even when assessing sustainability. The aim of the current study was to systematically develop a comprehensive definition of sustainability based on definitions already used in the literature. We searched for knowledge syntheses of sustainability and abstracted sustainability definitions from the articles identified through any relevant systematic and scoping reviews. The constructs in the abstracted sustainability definitions were mapped to an existing definition. The comprehensive definition of sustainability was revised to include emerging constructs. We identified four knowledge syntheses of sustainability, which identified 209 original articles. Of the 209 articles, 24 (11.5%) included a definition of sustainability. These definitions were mapped to three constructs from an existing definition, and nine new constructs emerged. We reviewed all constructs and created a revised definition: (1) after a defined period of time, (2) a program, clinical intervention, and/or implementation strategies continue to be delivered and/or (3) individual behavior change (i.e., clinician, patient) is maintained; (4) the program and individual behavior change may evolve or adapt while (5) continuing to produce benefits for individuals/systems. All 24 definitions were remapped to the comprehensive definition (percent agreement among three coders was 94%). Of the 24 definitions, 17 described the continued delivery of a program (70.8%), 17 mentioned continued outcomes (70.8%), 13 mentioned time (54.2%), 8 addressed the individual maintenance of a behavior change (33.3%), and 6 described the evolution or adaptation (25.0%). We drew from over 200 studies to identify 24 existing definitions of sustainability

T helper 17.1 cells associate with multiple sclerosis disease activity: perspectives for early intervention.

Science.gov (United States)

van Langelaar, Jamie; van der Vuurst de Vries, Roos M; Janssen, Malou; Wierenga-Wolf, Annet F; Spilt, Isis M; Siepman, Theodora A; Dankers, Wendy; Verjans, Georges M G M; de Vries, Helga E; Lubberts, Erik; Hintzen, Rogier Q; van Luijn, Marvin M

2018-05-01

Interleukin-17-expressing CD4+ T helper 17 (Th17) cells are considered as critical regulators of multiple sclerosis disease activity. However, depending on the species and pro-inflammatory milieu, Th17 cells are functionally heterogeneous, consisting of subpopulations that differentially produce interleukin-17, interferon-gamma and granulocyte macrophage colony-stimulating factor. In the current study, we studied distinct effector phenotypes of human Th17 cells and their correlation with disease activity in multiple sclerosis patients. T helper memory populations single- and double-positive for C-C chemokine receptor 6 (CCR6) and CXC chemokine receptor 3 (CXCR3) were functionally assessed in blood and/or cerebrospinal fluid from a total of 59 patients with clinically isolated syndrome, 35 untreated patients and 24 natalizumab-treated patients with relapsing-remitting multiple sclerosis, and nine patients with end-stage multiple sclerosis. Within the clinically isolated syndrome group, 23 patients had a second attack within 1 year and 26 patients did not experience subsequent attacks during a follow-up of >5 years. Low frequencies of T helper 1 (Th1)-like Th17 (CCR6+CXCR3+), and not Th17 (CCR6+CXCR3-) effector memory populations in blood strongly associated with a rapid diagnosis of clinically definite multiple sclerosis. In cerebrospinal fluid of clinically isolated syndrome and relapsing-remitting multiple sclerosis patients, Th1-like Th17 effector memory cells were abundant and showed increased production of interferon-gamma and granulocyte macrophage colony-stimulating factor compared to paired CCR6+ and CCR6-CD8+ T cell populations and their blood equivalents after short-term culturing. Their local enrichment was confirmed ex vivo using cerebrospinal fluid and brain single-cell suspensions. Across all pro-inflammatory T helper cells analysed in relapsing-remitting multiple sclerosis blood, Th1-like Th17 subpopulation T helper 17.1 (Th17.1; CCR6+CXCR3+CCR4

Multiple Eccrine Spiradenoma- An Unusual Clinical Presentation

Directory of Open Access Journals (Sweden)

Anita P. Javalgi

2017-04-01

Full Text Available Eccrine spiradenoma is an uncommon benign adnexal tumour of apocrine differentiation. It is commonly seen in young adults with no sex predilection on upper ventral aspect of body as a solitary papule or nodule. Here we are reporting a rare case of Multiple Eccrine Spiradenoma (MES in a 29 year male patient, who presented with multiple nodules on the anterior chest wall.

Clinical epidemiology.

Science.gov (United States)

Martin, S W; Bonnett, B

1987-06-01

Rational clinical practice requires deductive particularization of diagnostic findings, prognoses, and therapeutic responses from groups of animals (herds) to the individual animal (herd) under consideration This process utilizes concepts, skills, and methods of epidemiology, as they relate to the study of the distribution and determinants of health and disease in populations, and casts them in a clinical perspective.We briefly outline diagnostic strategies and introduce a measure of agreement, called kappa, between clinical diagnoses. This statistic is useful not only as a measure of diagnostic accuracy, but also as a means of quantifying and understanding disagreement between diagnosticians. It is disconcerting to many, clinicians included, that given a general deficit of data on sensitivity and specificity, the level of agreement between many clinical diagnoses is only moderate at best with kappa values of 0.3 to 0.6.Sensitivity, specificity, pretest odds, and posttest probability of disease are defined and related to the interpretation of clinical findings and ancillary diagnostic test results. An understanding of these features and how they relate to ruling-in or ruling-out a diagnosis, or minimizzing diagnostic errors will greatly enhance the diagnostic accuracy of the practitioner, and reduce the frequency of clinical disagreement. The approach of running multiple tests on every patient is not only wasteful and expensive, it is unlikely to improve the ability of the clinician to establish the correct diagnosis.We conclude with a discussion of how to decide on the best therapy, a discussion which centers on, and outlines the key features of, the well designed clinical trial. Like a diagnosis, the results from a clinical trial may not always be definitive, nonetheless it is the best available method of gleaning information about treatment efficacy.

Assuring Quality Control of Clinical Education in Multiple Clinical Affiliates.

Science.gov (United States)

Davis, Judith A.

A plan was developed to assure equivalency of clinical education among the medical laboratory technician (MLT) programs affiliated with Sandhills Community College. The plan was designed by faculty to monitor the quality of clinical courses offered by the clinical affiliates. The major strategies were to develop competencies, slide/tape modules, a…

Epidemiologic research using probabilistic outcome definitions.

Science.gov (United States)

Cai, Bing; Hennessy, Sean; Lo Re, Vincent; Small, Dylan S

2015-01-01

Epidemiologic studies using electronic healthcare data often define the presence or absence of binary clinical outcomes by using algorithms with imperfect specificity, sensitivity, and positive predictive value. This results in misclassification and bias in study results. We describe and evaluate a new method called probabilistic outcome definition (POD) that uses logistic regression to estimate the probability of a clinical outcome using multiple potential algorithms and then uses multiple imputation to make valid inferences about the risk ratio or other epidemiologic parameters of interest. We conducted a simulation to evaluate the performance of the POD method with two variables that can predict the true outcome and compared the POD method with the conventional method. The simulation results showed that when the true risk ratio is equal to 1.0 (null), the conventional method based on a binary outcome provides unbiased estimates. However, when the risk ratio is not equal to 1.0, the traditional method, either using one predictive variable or both predictive variables to define the outcome, is biased when the positive predictive value is value is poor (less than 0.75 in our simulation). In contrast, the POD method provides unbiased estimates of the risk ratio both when this measure of effect is equal to 1.0 and not equal to 1.0. Even when the sensitivity and positive predictive value are low, the POD method continues to provide unbiased estimates of the risk ratio. The POD method provides an improved way to define outcomes in database research. This method has a major advantage over the conventional method in that it provided unbiased estimates of risk ratios and it is easy to use. Copyright © 2014 John Wiley & Sons, Ltd.

Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod

Directory of Open Access Journals (Sweden)

Correale J

2016-06-01

each ingredient in each capsule/tablet and lower quality. Substandard, nonproprietary copies of medicines that are immunomodulatory or immunosuppressive are of concern to patients due to their possible untoward safety and lack of efficacy events. This article reviews the potential risks associated with nonproprietary medicines that do not meet the regulatory requirements of the United States Food and Drug Administration, the European Medicines Agency, or the World Health Organization. The clinical implications for patients are described. This article focuses on nonproprietary medicines for multiple sclerosis, particularly fingolimod, that are not identical to proprietary versions and could thus fail to meet efficacy expectations or have different impact on the safety of patients with multiple sclerosis.Keywords: bioequivalence, fingolimod, multiple sclerosis, proprietary, substandard copies, toxicity

The correlation between the astro consensus panel definition of biochemical failure and clinical outcome for patients with prostate cancer treated with external beam irradiation

International Nuclear Information System (INIS)

Horwitz, Eric M.; Vicini, Frank A.; Ziaja, Ellen L.; Dmuchowski, Carl F.; Stromberg, Jannifer S.; Matter, Richard C.; Martinez, Alvaro A.

1997-01-01

Purpose: The ASTRO Consensus Panel on PSA After Radiation Therapy recently recommended a definition of biochemical failure (BF) following treatment of prostate cancer with radiation therapy. We reviewed our institution's experience treating patients with external beam irradiation (RT) to determine if the Consensus Panel definition correlates with clinical distant metastases free survival (DMFS), disease free survival (DFS), cause specific survival (CSS), and local control (LC) rates for a large group of patients from the PSA era. Methods And Materials: Between 1/1/87 and 12/31/92, 653 patients with clinically localized prostate cancer received external beam irradiation (RT) using localized prostate fields at William Beaumont Hospital. Of these patients, 568 had a minimum follow-up of 2 years and constitute the study population. The median pre-treatment PSA and Gleason score was 11 ng/ml and 6, respectively. The median dose to the prostate using megavoltage RT was 66.6 Gy (range: 60-70.4 Gy) using a four field or arc technique. No patient received hormonal therapy either prior to, during, or after radiotherapy unless local or distant failure was documented. Pre-treatment and post-treatment serum PSA levels were recorded. Biochemical failure was defined as three consecutive increases in post-treatment PSA after achieving a nadir. Biochemical failure was recorded as the time midway between the nadir and first increase in PSA. Five year actuarial rates of DMFS, DFS, CSS, and LC were calculated for patients who were biochemically controlled (BC) versus those who failed biochemically. Results: Median follow-up was 56 months (range: 24-118 months). The overall 5 year actuarial rates of DMFS, DFS, CSS, and LC were significantly better in patients who were biochemically controlled versus those who were not (p< 0.001). The median time to DM within the BF group was 21 months (range: 2-112 months). When stratifying by pre-treatment PSA, Gleason score, and T stage, these

Multiplicative calculus in biomedical image analysis

NARCIS (Netherlands)

Florack, L.M.J.; Assen, van H.C.

2011-01-01

We advocate the use of an alternative calculus in biomedical image analysis, known as multiplicative (a.k.a. non-Newtonian) calculus. It provides a natural framework in problems in which positive images or positive definite matrix fields and positivity preserving operators are of interest. Indeed,

Catalog of 199 register-based definitions of chronic conditions

DEFF Research Database (Denmark)

Hvidberg, Michael F; Johnsen, Søren P; Glümer, Charlotte

2016-01-01

INTRODUCTION: The aim of the current study was to present and discuss a broad range of register-based definitions of chronic conditions for use in register research, as well as the challenges and pitfalls when defining chronic conditions by the use of registers. MATERIALS AND METHODS: The definit......INTRODUCTION: The aim of the current study was to present and discuss a broad range of register-based definitions of chronic conditions for use in register research, as well as the challenges and pitfalls when defining chronic conditions by the use of registers. MATERIALS AND METHODS......: The definitions were defined based on information from nationwide Danish public healthcare registers. Medical and epidemiological specialists identified and grouped relevant diagnosis codes that covered chronic conditions, using the International Classification System version 10 (ICD-10). Where relevant...... definitions were proposed based on record linkage between multiple registers, including registers of prescribed drugs and use of general practitioners' services. CONCLUSIONS THIS STUDY PROVIDED A CATALOG OF REGISTER-BASED DEFINITIONS FOR CHRONIC CONDITIONS FOR USE IN HEALTHCARE PLANNING AND RESEARCH, WHICH IS...

Additive versus multiplicative muon conservation

International Nuclear Information System (INIS)

Nemethy, P.

1981-01-01

Experimental elucidation of the question of muon conservation is reviewed. It is shown that neutral-current experiments have not yet yielded information about muonium-antimuonium conversion at the weak-interaction level and that all the charged-current experiments agree that there is no evidence for a multiplicative law. The best limits, from the muon-decay neutrino experiment at LAMPF and from the inverse muon-decay experiment in the CERN neutrino beam, definitely exclude multiplicative law schemes with a branching ratio R approximately 1/2. It is concluded that unless the dynamics conspire to make a multiplicative law with very small R it would appear that muon conservation obeys conserved additive lepton flavor law. (U.K.)

Toward a Meaningful Definition of Recovery After Hip Fracture: Comparing Two Definitions for Community-Dwelling Older Adults.

Science.gov (United States)

Auais, Mohammad; Morin, Suzanne N; Finch, Lois; Ahmed, Sara; Mayo, Nancy

2018-02-14

To examine the course of recovery and resulting health-related quality of life (HRQL) after low-trauma hip fracture using 2 different definitions of recovery. Inception cohort with 8 assessments over 1 year. Participants were recruited from a tertiary-care hospital and followed up in the community. Community-dwelling hip fracture patients (N=47, 75% of all eligible; aged ≥65y). Not applicable. Prefracture functional level was used to identify subgroups of participants with similar trajectories of mobility over time. Recovery in functional mobility was defined in 2 ways: the "traditional" definition (return to prefracture level of functional mobility) and a "targeted recovery" definition (ability to climb 10 steps). Both were measured using the Lower Extremity Functional Scale. HRQL was measured using the RAND 36-Item Short-Form Health Survey. Participants were categorized into 3 subgroups with: low, medium, and high prefracture functional abilities. Agreement between the 2 definitions of recovery (quantified using κ coefficient) was strong for the medium group (.81; 95% confidence interval, .56-1.00), weak for the high group (.46; 95% confidence interval, 0.0-.99), and minimal for the low group (.12; 95% confidence interval, 0.0-.328). Contrary to the traditional definition, patients who achieved targeted recovery had statistically and clinically better HRQL than the rest of the cohort throughout the study (estimated average difference of 10.8 points on RAND 36-Item Short-Form Health Survey; 95% confidence interval, 6.67-15.07). The agreement between the 2 definitions of recovery ranged from minimal to strong according to patient group. Using a functional target to define recovery predicted HRQL better. It is vital to consider the definition of recovery carefully for research or clinical practice because it can influence subsequent decisions (eg, endorsing a specific intervention or discharging patients). Copyright © 2018 American Congress of Rehabilitation

Clinical and economic burden of idiopathic pulmonary fibrosis in Quebec, Canada.

Science.gov (United States)

Tarride, Jean-Eric; Hopkins, Robert B; Burke, Natasha; Guertin, Jason R; O'Reilly, Daria; Fell, Charlene D; Dion, Genevieve; Kolb, Martin

2018-01-01

Idiopathic pulmonary fibrosis (IPF), although rare, is a severe and costly disease. To estimate the clinical and economic burden of IPF over multiple years before and after diagnosis using comprehensive administrative databases for the province of Quebec, Canada. Several administrative databases from Quebec, providing information on hospital care, community care, and pharmaceuticals, were linked over a 5-year period ending March 31, 2011, which was before approval of antifibrotic drugs in Canada. Prevalent and incident IPF cases were defined using International Classification Disease-10-CA codes and International Classification Disease-9-CM codes. We used a broad definition that excluded cases with subsequent diagnosis of other interstitial lung diseases and a narrow definition that required further diagnostic testing to confirm IPF diagnosis. Incident cases had an IPF code in a particular year without any IPF code in the 2 previous years. Health care resource utilization before and after the index diagnosis date was determined and costs calculated. Costs were expressed in 2016 Canadian dollars. Over 5-years, 10,579 (mean age: 76.4; 58% male) satisfied the broad definition of IPF and 8,683 (mean age: 74.5; 57% male) satisfied the narrow definition (82% of broad). Incidences of IPF overall were 25.8 and 21.7/100,000 population for broad and narrow definitions, respectively. Three-year survival was 40% and 37% in broad and narrow cohorts, respectively. For both cohorts, health care resource utilization and costs increased several years before diagnosis ($2,721 and $7,049/patient 5 years and 2 years prior to diagnosis using a broad definition, respectively) and remained elevated for multiple years post diagnosis ($12,978 and $8,267 at 2 and 3 years postdiagnosis). Health care resource utilization and costs of IPF increase many years prior to diagnosis. Incorporating multiyear annual costs before and after diagnosis results in a higher estimate of the economic burden

Mediation analysis with multiple versions of the mediator

OpenAIRE

VanderWeele, Tyler J.

2012-01-01

The causal inference literature has provided definitions of direct and indirect effects based on counterfactuals that generalize the approach found in the social science literature. However, these definitions presuppose well defined hypothetical interventions on the mediator. In many settings there may be multiple ways to fix the mediator to a particular value and these different hypothetical interventions may have very different implications for the outcome of interest. In this paper we cons...

The definition and natural history of severe exacerbation of hepatitis B

Directory of Open Access Journals (Sweden)

GUO Wei

2014-10-01

Full Text Available Despite different opinions on its definition and classification in the past, a consensus has gradually been reached regarding the naming, classification, and clinical diagnosis of liver failure. The classification of liver failure is described, and the definition and natural history of severe exacerbation of hepatitis B are summarized. Antiviral treatment and artificial liver support in the early stage are beneficial for clinical outcomes and prognosis.

Diagnostic Consideration for Sinonasal Wegener’s Granulomatosis Clinically Mistaken for Carcinoma

Directory of Open Access Journals (Sweden)

Cristina La Rosa

2013-01-01

Full Text Available We report a case of Wegener’s granulomatosis clinically mistaken for carcinoma in a 21-year-old girl presenting with an ulcerated mass of the nasopharynx associated with enlarged laterocervical nodes. The lesion was clinically suspected as malignant on the basis of clinical and radiological findings (namely, computed tomography scan and positron emission tomography. However, multiple biopsies were not conclusive for malignancy showing histological change suggestive of Wegener’s granulomatosis. A serum determination of cANCA supported the diagnosis of Wegener’s granulomatosis. Clinical findings and image studies suggested an erroneous diagnosis of malignancy whereas a definitive diagnosis of Wegener’s granulomatosis was achieved only after repeated biopsies thus leading to a correct therapeutic approach. The Wegener granulomatosis must be added to the list of the differential diagnoses of the masses of the nasopharynx associated with or without enlarged laterocervical nodes.

A new T2 lesion in a patient with the clinically isolated syndrome does not necessarily imply a conversion to multiple sclerosis.

Science.gov (United States)

Capone, Fioravante; Puthenparampil, Marco; Mallio, Carlo Augusto; Celia, Alessandra Ida; Florio, Lucia; Gallo, Paolo; Di Lazzaro, Vincenzo

2018-01-01

In the follow-up of patients with the clinically isolated syndrome, both clinical and MRI findings should be carefully evaluated by clinicians to avoid misinterpretation and inappropriate diagnosis of multiple sclerosis. We describe a case of a patient with a previous diagnosis of clinically isolated syndrome who developed a new asymptomatic brain lesion at the MRI follow-up. The careful evaluation of clinical history and radiological findings allowed the correct diagnosis of cocaine-associated ischemic stroke. Our case highlights that, in patients with the clinically isolated syndrome, the appearance of a new lesion on MRI does not necessarily imply a conversion to multiple sclerosis. Among "better explanations", ischemic lesions are of relevance and, in patients without typical risk factors for stroke, rarer causes such as cocaine assumption should be considered. Copyright © 2017 Elsevier B.V. All rights reserved.

CT abnormality in multiple sclerosis analysis based on 28 probable cases and correlation with clinical manifestations

International Nuclear Information System (INIS)

Kakigi, Ryusuke; Shibasaki, Hiroshi; Tabira, Takeshi; Kuroiwa, Yoshigoro; Numaguchi, Yuji.

1981-01-01

In order to investigate the occurrence and nature of CT abnormality and its correlation with clinical manifestations in multiple sclerosis, 34 CT records obtained from 28 consecutive patients with probable multiple sclerosis were reviewed. Forty-six percent of all cases showed abnormal CT. Dilatation of cortical sulci was found in 39%; dilatation of the lateral ventricle in 36%; dilatation of prepontine or cerebello-pontine cistern and the fourth ventricle, suggesting brainstem atrophy, in 18%; dilatation of cerebellar sulci, superior cerebellar cistern and cisterna magna, suggesting cerebellar atrophy, in 11%. Low density area was found in the cerebral hemisphere in 11% of cases. Contrast enhancement, performed on 25 CT records, did not show any change. There was no correlation between CT abnormality and duration of the illness. Although abnormal CT tended to occur more frequently during exacerbations and chronic stable state than during remissions, the difference was not statistically significant. CT abnormalities suggesting brainstem atrophy, cerebellar atrophy or plaques were found exclusively during exacerbations and chronic stable state. The occurrence of CT abnormalities was not significantly different among various clinical forms which were classified based on clinically estimated sites of lesion, except that abnormal CT tended to occur less frequently in cases classified as the optic-spinal form. It is noteworthy that cerebral cortical atrophy and/or dilatation of the lateral ventricle were found in 31% of cases who did not show any clinical sign of cerebral involvement. There was a statistically significant correlation between CT abnormalities and levels of clinical disability. Eighty percent of the bedridden or severely disabled patients showed abnormal CT, in contrast with only 29% of those with moderate, slight or no disability. (author)

CT abnormality in multiple sclerosis analysis based on 28 probable cases and correlation with clinical manifestations

Energy Technology Data Exchange (ETDEWEB)

Kakigi, R.; Shibasaki, H.; Tabira, T.; Kuroiwa, Y. (Kyushu Univ., Fukuoka (Japan). Faculty of Medicine); Numaguchi, Y.

1981-10-01

In order to investigate the occurrence and nature of CT abnormality and its correlation with clinical manifestations in multiple sclerosis, 34 CT records obtained from 28 consecutive patients with probable multiple sclerosis were reviewed. Forty-six percent of all cases showed abnormal CT. Dilatation of cortical sulci was found in 39%; dilatation of the lateral ventricle in 36%; dilatation of prepontine or cerebello-pontine cistern and the fourth ventricle, suggesting brainstem atrophy, in 18%; dilatation of cerebellar sulci, superior cerebellar cistern and cisterna magna, suggesting cerebellar atrophy, in 11%. Low density area was found in the cerebral hemisphere in 11% of cases. Contrast enhancement, performed on 25 CT records, did not show any change. There was no correlation between CT abnormality and duration of the illness. Although abnormal CT tended to occur more frequently during exacerbations and chronic stable state than during remissions, the difference was not statistically significant. CT abnormalities suggesting brainstem atrophy, cerebellar atrophy or plaques were found exclusively during exacerbations and chronic stable state. The occurrence of CT abnormalities was not significantly different among various clinical forms which were classified based on clinically estimated sites of lesion, except that abnormal CT tended to occur less frequently in cases classified as the optic-spinal form. It is noteworthy that cerebral cortical atrophy and/or dilatation of the lateral ventricle were found in 31% of cases who did not show any clinical sign of cerebral involvement. There was a statistically significant correlation between CT abnormalities and levels of clinical disability. Eighty percent of the bedridden or severely disabled patients showed abnormal CT, in contrast with only 29% of those with moderate, slight or no disability.

Risk definitions - risk research is done in multiple disciplines; but is it multidisciplinary?:

DEFF Research Database (Denmark)

Berg-Beckhoff, Gabriele; Wiedemann, Peter; Adam, Balazs

2015-01-01

Background The aim of the project was to assess the definitions of hazard, risk, and their assessment used in different scientific disciplines and to give examples of the potential implications in the scientific discussions as well as in risk communication. Method The following disciplines were...... involved: public health, psychology, environmental health, occupational health, engineering, sociology and medicine. From each discipline a scientist was asked to present their own views on the given topics. Questions were developed together to get comparable responses from participants. Result......: The surprising result was that, when working together, pre-given major differences disappeared. Hazard is an adverse event or condition, mostly expressed in qualitative terms. For most risk definitions probability and severity are both important aspects and often a quantification of risk is desired, whereas risk...

[Severe hypertension: definition and patients profiles].

Science.gov (United States)

Mourad, Jean-Jacques

2013-05-01

Severe arterial hypertension gathers relatively different clinical situations explained by the heterogeneity of the definitions of this clinical setting. From a medical point of view, severe hypertension is a short course situation defined by very high values of blood pressure corresponding to grade 3 hypertension. In France, until 2011, the social security also included in the definition of severe HTA chronic situations characterized by moderate blood pressure values requiring at least triple anthihypertensive therapies associated with a clinical or infraclinical target organ damages. These clinical profiles, much more frequent than grade 3 hypertension, allowed the full reimbursement of care costs for these patients. In France, it is estimated that 10% of hypertensive patients present a severe form with an annual incidence of 50,000 patients. The patients with severe hypertension have an increased cardiovascular morbidity justifying a closer clinical monitoring. From an economic point of view, these severe forms of hypertension have a higher cost of care, explained primarily by a more frequent need of specialized referrals, radiological exams and hospitalizations. This excess cost justified the existence of a full coverage of induced costs by the social security, since the incidence of severe hypertension is more frequent in the low social categories, and in patients with economic fragility.

Acute respiratory distress syndrome: the Berlin Definition.

Science.gov (United States)

Ranieri, V Marco; Rubenfeld, Gordon D; Thompson, B Taylor; Ferguson, Niall D; Caldwell, Ellen; Fan, Eddy; Camporota, Luigi; Slutsky, Arthur S

2012-06-20

The acute respiratory distress syndrome (ARDS) was defined in 1994 by the American-European Consensus Conference (AECC); since then, issues regarding the reliability and validity of this definition have emerged. Using a consensus process, a panel of experts convened in 2011 (an initiative of the European Society of Intensive Care Medicine endorsed by the American Thoracic Society and the Society of Critical Care Medicine) developed the Berlin Definition, focusing on feasibility, reliability, validity, and objective evaluation of its performance. A draft definition proposed 3 mutually exclusive categories of ARDS based on degree of hypoxemia: mild (200 mm Hg < PaO2/FIO2 ≤ 300 mm Hg), moderate (100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg), and severe (PaO2/FIO2 ≤ 100 mm Hg) and 4 ancillary variables for severe ARDS: radiographic severity, respiratory system compliance (≤40 mL/cm H2O), positive end-expiratory pressure (≥10 cm H2O), and corrected expired volume per minute (≥10 L/min). The draft Berlin Definition was empirically evaluated using patient-level meta-analysis of 4188 patients with ARDS from 4 multicenter clinical data sets and 269 patients with ARDS from 3 single-center data sets containing physiologic information. The 4 ancillary variables did not contribute to the predictive validity of severe ARDS for mortality and were removed from the definition. Using the Berlin Definition, stages of mild, moderate, and severe ARDS were associated with increased mortality (27%; 95% CI, 24%-30%; 32%; 95% CI, 29%-34%; and 45%; 95% CI, 42%-48%, respectively; P < .001) and increased median duration of mechanical ventilation in survivors (5 days; interquartile [IQR], 2-11; 7 days; IQR, 4-14; and 9 days; IQR, 5-17, respectively; P < .001). Compared with the AECC definition, the final Berlin Definition had better predictive validity for mortality, with an area under the receiver operating curve of 0.577 (95% CI, 0.561-0.593) vs 0.536 (95% CI, 0.520-0.553; P�

Clinical trials in "emerging markets": regulatory considerations and other factors.

Science.gov (United States)

Singh, Romi; Wang, Ouhong

2013-11-01

Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

Multiple Primary Tumors

African Journals Online (AJOL)

2017-12-05

Dec 5, 2017 ... Multiple primary tumors occur in clinical practice causing diagnostic dilemma. It is not very .... was estrogen receptor negative, progesterone receptor negative, and ... cervical, ovarian, and urinary bladder cancers. Multiple.

Parkinson's disease-related fatigue: A case definition and recommendations for clinical research.

Science.gov (United States)

Kluger, Benzi M; Herlofson, Karen; Chou, Kelvin L; Lou, Jau-Shin; Goetz, Christopher G; Lang, Anthony E; Weintraub, Daniel; Friedman, Joseph

2016-05-01

Fatigue is one of the most common and disabling symptoms in Parkinson's disease (PD). Since fatigue was first described as a common feature of PD 20 years ago, little progress has been made in understanding its causes or treatment. Importantly, PD patients attending the 2013 World Parkinson Congress voted fatigue as the leading symptom in need of further research. In response, the Parkinson Disease Foundation and ProjectSpark assembled an international team of experts to create recommendations for clinical research to advance this field. The working group identified several areas in which shared standards would improve research quality and foster progress including terminology, diagnostic criteria, and measurement. Terminology needs to (1) clearly distinguish fatigue from related phenomena (eg, sleepiness, apathy, depression); (2) differentiate subjective fatigue complaints from objective performance fatigability; and (3) specify domains affected by fatigue and causal factors. We propose diagnostic criteria for PD-related fatigue to guide participant selection for clinical trials and add rigor to mechanistic studies. Recommendations are made for measurement of subjective fatigue complaints, performance fatigability, and neurophysiologic changes. We also suggest areas in which future research is needed to address methodological issues and validate or optimize current practices. Many limitations in current PD-related fatigue research may be addressed by improving methodological standards, many of which are already being successfully applied in clinical fatigue research in other medical conditions (eg, cancer, multiple sclerosis). © 2016 International Parkinson and Movement Disorder Society. © 2016 International Parkinson and Movement Disorder Society.

Multiple myeloma

International Nuclear Information System (INIS)

Sohn, Jeong Ick; Ha, Choon Ho; Choi, Karp Shik

1994-01-01

Multiple myeloma is a malignant plasma cell tumor that is thought to originate proliferation of a single clone of abnormal plasma cell resulting production of a whole monoclonal paraprotein. The authors experienced a case of multiple myeloma with severe mandibular osteolytic lesions in 46-year-old female. As a result of careful analysis of clinical, radiological, histopathological features, and laboratory findings, we diagnosed it as multiple myeloma, and the following results were obtained. 1. Main clinical symptoms were intermittent dull pain on the mandibular body area, abnormal sensation of lip and pain due to the fracture on the right clavicle. 2. Laboratory findings revealed M-spike, reversed serum albumin-globulin ratio, markedly elevated ESR and hypercalcemia. 3. Radiographically, multiple osteolytic punched-out radiolucencies were evident on the skull, zygoma, jaw bones, ribs, clavicle and upper extremities. Enlarged liver and increased uptakes on the lesional sites in RN scan were also observed. 4. Histopathologically, markedly hypercellular marrow with sheets of plasmoblasts and megakaryocytes were also observed.

Analyzing clinical symptoms in multiple sclerosis using data mining

Directory of Open Access Journals (Sweden)

Zahra Raeisi

2017-04-01

Full Text Available Background: One of the today most common and incurable diseases that is associated with central neural system is ‘MS’ disease. Multiple sclerosis (MS is a demyelinating disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged. In this disease become apparent a wide spectrum of symptoms such as lose muscles control and their coordination and vision derangement. The goal of this research is to consider to two problems: 1- Recognition of effective clinical symptoms on MS disease and 2- Considering levels of effectiveness of age, sex and education levels factors on MS disease and association between these factors according to verity of categories of this disease. Methods: Data mining science in medicine is worthy of attention with main application in diagnosis, therapy and prognosis, respectively high volume of collected datum. The data that were used in this article are about patients of Chaharmahal and Bakhtiari Province and collected by cure assistance. In this paper classification and association methods in software engineering field are used. Classification is a general process related to categorization, the process in which ideas and objects are recognized, differentiated, and understood. Association rules are created by analyzing data for frequent if/then patterns and using the criteria support and confidence to identify the most important relationships. Results: In consideration of first problem in this paper, concluded vision-clinical symptoms are the most effective symptoms and in consideration of second problem, concluded that from 584 records, women affected four times more than men. In other word 70% of MS patients with high graduate are in relapsing-remitting category and 62.5% of MS patients are 20-40 years old. Conclusion: Some of symptoms are quite temporary and transitory and are ignored by people. Awareness of clinical-symptoms prevalence manner can be warning for people before starting

The optimal definition of contrast-induced acute kidney injury for prediction of inpatient mortality in patients undergoing percutaneous coronary interventions.

Science.gov (United States)

Parsh, Jessica; Seth, Milan; Briguori, Carlo; Grossman, Paul; Solomon, Richard; Gurm, Hitinder S

2016-05-01

It is unknown which definition of contrast-induced acute kidney injury (CI-AKI) in the setting of percutaneous coronary interventions is best associated with inpatient mortality and whether this association is stable across patients with various preprocedural serum creatinine (SCr) values. We applied logistic regression models to multiple CI-AKI definitions used by the Kidney Disease Improving Global Outcomes guidelines and previously published studies to examine the impact of preprocedural SCr on a candidate definition's correlation with the adverse outcome of inpatient mortality. We used likelihood ratio tests to examine candidate definitions and identify those where association with inpatient mortality remained constant regardless of preprocedural SCr. These definitions were assessed for specificity, sensitivity, and positive and negative predictive values to identify an optimal definition. Our study cohort included 119,554 patients who underwent percutaneous coronary intervention in Michigan between 2010 and 2014. Most commonly used definitions were not associated with inpatient mortality in a constant fashion across various preprocedural SCr values. Of the 266 candidate definitions examined, 16 definition's association with inpatient mortality was not significantly altered by preprocedural SCr. Contrast-induced acute kidney injury defined as an absolute increase of SCr ≥0.3 mg/dL and a relative SCr increase ≥50% was selected as the optimal candidate using Perkins and Shisterman decision theoretic optimality criteria and was highly predictive of and specific for inpatient mortality. We identified the optimal definition for CI-AKI to be an absolute increase in SCr ≥0.3 mg/dL and a relative SCr increase ≥50%. Further work is needed to validate this definition in independent studies and to establish its utility for clinical trials and quality improvement efforts. Copyright © 2016 Elsevier Inc. All rights reserved.

Load-dependent dysfunction of the putamen during attentional processing in patients with clinically isolated syndrome suggestive of multiple sclerosis.

Science.gov (United States)

Tortorella, C; Romano, R; Direnzo, V; Taurisano, P; Zoccolella, S; Iaffaldano, P; Fazio, L; Viterbo, R; Popolizio, T; Blasi, G; Bertolino, A; Trojano, M

2013-08-01

Load-related functional magnetic resonance imaging (fMRI) abnormalities of brain activity during performance of attention tasks have been described in definite multiple sclerosis (MS). No data are available in clinically isolated syndrome (CIS) suggestive of MS. The objective of this research is to evaluate in CIS patients the fMRI pattern of brain activation during an attention task and to explore the effect of increasing task load demand on neurofunctional modifications. Twenty-seven untreated CIS patients and 32 age- and sex-matched healthy controls (HCs) underwent fMRI while performing the Variable Attentional Control (VAC) task, a cognitive paradigm requiring increasing levels of attentional control processing. Random-effects models were used for statistical analyses of fMRI data. CIS patients had reduced accuracy and greater reaction time at the VAC task compared with HCs (p=0.007). On blood oxygenation level-dependent (BOLD)-fMRI, CIS patients had greater activity in the right parietal cortex (p=0.0004) compared with HCs. Furthermore, CIS patients had greater activity at the lower (p=0.05) and reduced activity at the greater (p=0.04) level of attentional control demand in the left putamen, compared with HCs. This study demonstrates the failure of attentional control processing in CIS. The load-related fMRI dysfunction of the putamen supports the role of basal ganglia in the failure of attention observed at the earliest stage of MS.

Interaural multiple frequency tympanometry measures: clinical utility for unilateral conductive hearing loss.

Science.gov (United States)

Norrix, Linda W; Burgan, Briana; Ramirez, Nicholas; Velenovsky, David S

2013-03-01

Tympanometry is a routine clinical measurement of the acoustic immittance of the ear as a function of ear canal air pressure. The 226 Hz tympanogram can provide clinical evidence for conditions such as a tympanic membrane perforation, Eustachian tube dysfunction, middle ear fluid, and ossicular discontinuity. Multiple frequency tympanometry using a range of probe tone frequencies from low to high has been shown to be more sensitive than a single probe tone tympanogram in distinguishing between mass- and stiffness-related middle ear pathologies (Colletti, 1975; Funasaka et al, 1984; Van Camp et al, 1986). In this study we obtained normative measures of middle ear resonance by using multiple probe tone frequency tympanometry. Ninety percent ranges for middle ear resonance and for interaural differences were calculated. In a mixed design, normative data were collected from both ears of male and female adults. Twelve male and 12 female adults with normal hearing and normal middle ear function participated in the study. Multiple frequency tympanograms were recorded with a commercially available immittance instrument (GSI Tympstar) to obtain estimates of middle ear resonant frequency (RF) using ΔB, positive tail, and negative tail methods. Data were analyzed using three-way mixed analyses of variance with gender as a between-subject variable and ear and method as within-subject variables. T-tests were performed, using the Bonferroni adjustment, to determine significant differences between means. Using the positive and negative tail methods, a wide range of approximately 500 Hz was found for middle ear resonance in adults with normal hearing and normal middle ear function. The difference in RF between an individual's ears is small with 90% ranges of approximately ±200 Hz, indicating that the right ear RF should be either 200 Hz higher or lower in frequency compared to the left ear. This was true for both negative and positive tail methods. Ninety percent ranges were

The effectiveness of music as a mnemonic device on recognition memory for people with multiple sclerosis.

Science.gov (United States)

Moore, Kimberly Sena; Peterson, David A; O'Shea, Geoffrey; McIntosh, Gerald C; Thaut, Michael H

2008-01-01

Research shows that people with multiple sclerosis exhibit learning and memory difficulties and that music can be used successfully as a mnemonic device to aid in learning and memory. However, there is currently no research investigating the effectiveness of music mnemonics as a compensatory learning strategy for people with multiple sclerosis. Participants with clinically definitive multiple sclerosis (N = 38) were given a verbal learning and memory test. Results from a recognition memory task were analyzed that compared learning through music (n = 20) versus learning through speech (n = 18). Preliminary baseline neuropsychological data were collected that measured executive functioning skills, learning and memory abilities, sustained attention, and level of disability. An independent samples t test showed no significant difference between groups on baseline neuropsychological functioning or on recognition task measures. Correlation analyses suggest that music mnemonics may facilitate learning for people who are less impaired by the disease. Implications for future research are discussed.

Multiple Meixner polynomials and non-Hermitian oscillator Hamiltonians

OpenAIRE

Ndayiragije, François; Van Assche, Walter

2013-01-01

Multiple Meixner polynomials are polynomials in one variable which satisfy orthogonality relations with respect to $r>1$ different negative binomial distributions (Pascal distributions). There are two kinds of multiple Meixner polynomials, depending on the selection of the parameters in the negative binomial distribution. We recall their definition and some formulas and give generating functions and explicit expressions for the coefficients in the nearest neighbor recurrence relation. Followi...

[How to Understand "Clinical Ethics" and "Research Ethics" in Clinical Settings--Incorporation of IRB, REC, and CEC in Hospital Organizations].

Science.gov (United States)

Ita, Koichiro

2016-02-01

As the traditional definition of "medical ethics" has recently changed markedly with advances in medical knowledge and technology, medical doctors and researchers in Japan are required to understand and apply both research and clinical ethics. Quite frequently, ethical problems in clinical settings cannot be addressed by the simple application of good will, hard work, and perseverance by medical personnel. The Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) have jointly published "Ethical Guidelines for Clinical Studies;" however, clear guidelines (legal, ministerial, or governmental) outlining the expectations regarding clinical ethics do not exist. All medical personnel face deep ethical dilemmas. In these instances, if the fulfillment of 'ethics' relies solely on the capacity of personnel to apply their own individual moral efforts, the result will be burn-out among these workers who have a strong sense of responsibility. In order to avoid this, a system which comprises multiple physicians, nurses, and other personnel must be established, allowing collaboration when an appropriate response is required. A major factor supporting this approach is the offering of Clinical Ethics Consultations.

Initial Clinical Experience in Multiple Myeloma Staging by Means of Whole-Body Resonance Techniques

International Nuclear Information System (INIS)

Gallego, J. I.; Concepcion, L.; Alonso, S.; Sanchez, B.; Manzi, F.

2003-01-01

To develop a magnetic resonance (MR) exploratory technique equivalent to serial bone X-ray, and to compare their precision in the staging of multiple myeloma (MM) patients. Multiple acquisition T1-weights TSE and STIR sequences in the coronal plane were performed. Ten healthy volunteers and 11 multiple myeloma diagnosed patients were included. The visualization of bony structures was particularly noted,with special attention given to those which would normally be included in a serial bone X-ray. In the case of the patients, a comparison was made between diagnostic capacities of the MR sequences. MR highlighters significantly more (p<0.05) bony elements than did the serial bone X-ray. This was greatly due to a sequential displacement of the scanner bed, allowing for field-of-views which were minimally from head to third proximal of the leg. Magnetic resonance detected a significantly higher number (p<0.05) of lesions. It was, in turn, capable of revealing greater lesion extensions, even to the point of implying staging classification changes in 18% of the patients. The utilization of whole-body MR techniques in multiple myeloma patients is feasible and clinically beneficial. MR is both more sensitive and more specific than serial bone X-ray for evaluation of bony lesions in MM. It is currently serving as a valid alternative in a growing numbers of patients. (Author) 10 refs

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

DEFF Research Database (Denmark)

Kraus, V B; Blanco, F J; Englund, M

2015-01-01

Osteoarthritis (OA) is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for OA that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and ...... sophisticated definitions, terminology and tools....

Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition.

Science.gov (United States)

Gilbert, Peter B; Gabriel, Erin E; Huang, Ying; Chan, Ivan S F

2015-09-01

A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment effects in future studies without needing to collect the clinical endpoint data. Within the principal stratification framework for addressing this problem based on data from a single randomized clinical efficacy trial, a variety of definitions and criteria for a good surrogate endpoint have been proposed, all based on or closely related to the "principal effects" or "causal effect predictiveness (CEP)" surface. We discuss CEP-based criteria for a useful surrogate endpoint, including (1) the meaning and relative importance of proposed criteria including average causal necessity (ACN), average causal sufficiency (ACS), and large clinical effect modification; (2) the relationship between these criteria and the Prentice definition of a valid surrogate endpoint; and (3) the relationship between these criteria and the consistency criterion (i.e., assurance against the "surrogate paradox"). This includes the result that ACN plus a strong version of ACS generally do not imply the Prentice definition nor the consistency criterion, but they do have these implications in special cases. Moreover, the converse does not hold except in a special case with a binary candidate surrogate. The results highlight that assumptions about the treatment effect on the clinical endpoint before the candidate surrogate is measured are influential for the ability to draw conclusions about the Prentice definition or consistency. In addition, we emphasize that in some scenarios that occur commonly in practice, the principal strata sub-populations for inference are identifiable from the observable data, in which cases the principal stratification framework has relatively high utility for the purpose of effect

Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition

Science.gov (United States)

Gilbert, Peter B.; Gabriel, Erin E.; Huang, Ying; Chan, Ivan S.F.

2015-01-01

A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment effects in future studies without needing to collect the clinical endpoint data. Within the principal stratification framework for addressing this problem based on data from a single randomized clinical efficacy trial, a variety of definitions and criteria for a good surrogate endpoint have been proposed, all based on or closely related to the “principal effects” or “causal effect predictiveness (CEP)” surface. We discuss CEP-based criteria for a useful surrogate endpoint, including (1) the meaning and relative importance of proposed criteria including average causal necessity (ACN), average causal sufficiency (ACS), and large clinical effect modification; (2) the relationship between these criteria and the Prentice definition of a valid surrogate endpoint; and (3) the relationship between these criteria and the consistency criterion (i.e., assurance against the “surrogate paradox”). This includes the result that ACN plus a strong version of ACS generally do not imply the Prentice definition nor the consistency criterion, but they do have these implications in special cases. Moreover, the converse does not hold except in a special case with a binary candidate surrogate. The results highlight that assumptions about the treatment effect on the clinical endpoint before the candidate surrogate is measured are influential for the ability to draw conclusions about the Prentice definition or consistency. In addition, we emphasize that in some scenarios that occur commonly in practice, the principal strata sub-populations for inference are identifiable from the observable data, in which cases the principal stratification framework has relatively high utility for the purpose of

Utility of providing a concussion definition in the assessment of concussion history in former NFL players.

Science.gov (United States)

Alosco, Michael L; Jarnagin, Johnny; Tripodis, Yorghos; Martin, Brett; Chaisson, Christine; Baugh, Christine M; Torres, Alcy; Nowinski, Christopher J; Cantu, Robert C; Stern, Robert A

2017-01-01

Former National Football League (NFL) players' working knowledge of concussion has not yet been evaluated, despite this population being a major clinical research target due to the association between repetitive head impacts (RHI) and long-term clinical impairments. This study examined former NFL players' understanding of the current concussion definition, and the association between number of concussions with clinical function. 95 former NFL players (mean age = 55.29; mean NFL year = 8.10) self-reported number of concussions before being provided with a concussion definition and after being read a modern definition of concussion. Subjects reported number of concussions with loss of consciousness (LOC). Principal Component Analysis of a battery of tests generated behaviour/mood, psychomotor speed/executive function, and verbal and visual memory factor scores. Post-definition number of concussions (median = 50) was five times the pre-definition (median = 10; p football played, with specific effects for depressive symptoms and impulsivity. LOC did not account for variance beyond number of concussions. Practitioners and clinical researchers should provide a definition of concussion in the assessment of concussion history in former football players to facilitate accuracy and standardization.

Challenges in clinical studies with multiple imaging probes

International Nuclear Information System (INIS)

Krohn, Kenneth A.; O'Sullivan, Finbarr; Crowley, John; Eary, Janet F.; Linden, Hannah M.; Link, Jeanne M.; Mankoff, David A.; Muzi, Mark; Rajendran, Joseph G.; Spence, Alexander M.; Swanson, Kristin R.

2007-01-01

This article addresses two related issues: (a) When a new imaging agent is proposed, how does the imager integrate it with other biomarkers, either sampled or imaged? (b) When we have multiple imaging agents, is the information additive or duplicative and how is this objectively determined? Molecular biology is leading to new treatment options with reduced normal tissue toxicity, and imaging should have a role in objectively evaluating new treatments. There are two roles for molecular characterization of disease. Molecular imaging measurements before therapy help predict the aggressiveness of disease and identify therapeutic targets and, therefore, help choose the optimal therapy for an individual. Measurements of specific biochemical processes made during or after therapy should be sensitive measures of tumor response. The rules of evidence are not fully developed for the prognostic role of imaging biomarkers, but the potential of molecular imaging provides compelling motivation to push forward with convincing validation studies. New imaging procedures need to be characterized for their effectiveness under realistic clinical conditions to improve the management of patients and achieve a better outcome. The purpose of this article is to promote a critical discussion within the molecular imaging community because our future value to the overall biomedical community will be in supporting better treatment outcomes rather than in detection

Can a physician predict the clinical response to first-line immunomodulatory treatment in relapsing–remitting multiple sclerosis?

Directory of Open Access Journals (Sweden)

Mezei Z

2012-10-01

Full Text Available Zsolt Mezei,1 Daniel Bereczki,1,2 Lilla Racz,1 Laszlo Csiba,1 Tunde Csepany11Department of Neurology, University of Debrecen, Debrecen, Hungary; 2Department of Neurology, Semmelweis University, Budapest, HungaryBackground: Decreased relapse rate and slower disease progression have been reported with long-term use of immunomodulatory treatments (IMTs, interferon beta or glatiramer acetate in relapsing–remitting multiple sclerosis. There are, however, patients who do not respond to such treatments, and they can be potential candidates for alternative therapeutic approaches.Objective: To identify clinical factors as possible predictors of poor long-term response.Methods: A 9-year prospective, continuous follow-up at a single center in Hungary to assess clinical efficacy of IMT.Results: In a patient group of 81 subjects with mean IMT duration of 54 ± 33 months, treatment efficacy expressed as annual relapse rate and change in clinical severity from baseline did not depend on the specific IMT (any of the interferon betas or glatiramer acetate, and on mono- or multifocal features of the initial appearance of the disease. Responders had shorter disease duration and milder clinical signs at the initiation of treatment. Relapse-rate reduction in the initial 2 years of treatment predicted clinical efficacy in subsequent years.Conclusion: Based on these observations, we suggest that a 2-year trial period is sufficient to decide on the efficacy of a specific IMT. For those with insufficient relapse reduction in the first 2 years of treatment, a different IMT or other therapeutic approaches should be recommended.Keywords: multiple sclerosis, immunomodulatory, EDSS, relapse, response

Clinical utility and patient consideration in the use of lenalidomide for multiple myeloma in Chinese patients

Directory of Open Access Journals (Sweden)

Wang J

2015-06-01

Full Text Available Jing Wang, Hongfeng Guo, Xin Zhou Department of Hematology, Wuxi People’s Hospital, Nanjing Medical University, Wuxi, People’s Republic of China Abstract: Multiple myeloma (MM is an incurable hematologic malignancy caused by the autonomous growth of malignant plasma cells. In the last decade, the introduction of novel targeted agents such as thalidomide, bortezomib, and lenalidomide has dramatically improved the clinical outcome of MM patients in both the frontline and recurrent settings. Lenalidomide is a synthetic derivative of thalidomide, which has been shown to significantly improve overall survival, time to progression, and overall response rates in patients with MM. The China Food and Drug Administration approved the use of lenalidomide in patients with MM in 2013. In a Phase II trial, lenalidomide plus low-dose dexamethasone was associated with a high response rate and acceptable safety profile in heavily pretreated Chinese patients with relapsed/refractory MM, including those with renal impairment and IgD subtype. However, lenalidomide will remain as a second-line antimyeloma drug in the near future because of its high price and the policy of health insurance reimbursement in People’s Republic of China. In this review, we summarize the clinical utility and patient considerations in the use of lenalidomide for MM in Chinese patients. Further studies with larger sample sizes are required to investigate the better quality, longer duration, and more clinically meaningful outcomes of lenalidomide in the treatment of MM in Chinese patients. Keywords: lenalidomide, multiple myeloma, clinical efficacy, Chinese patients

"Research on Infertility: Definition Makes a Difference" Revisited.

Science.gov (United States)

Jacobson, Melanie H; Chin, Helen B; Mertens, Ann C; Spencer, Jessica B; Fothergill, Amy; Howards, Penelope P

2018-02-01

In a 1989 paper, Marchbanks et al. (Am J Epidemiol. 1989;130(2):259-267) noted inconsistent definitions of infertility across research and clinical practice and examined differences in prevalence estimates across definitions. Since their study, there have been substantial changes in society, technology, and clinical practice related to female reproductive health. In response, we revisited the original paper using data from a recent study among reproductive-aged women. Internal comparisons across various definitions of infertility were made by assessing how many and which women were classified as infertile, their age at infertility, and the probability of spontaneous pregnancy after infertility. Results were also compared with Marchbanks et al. Black women were more likely to be classified as infertile than white women based on the definition "12 months of unprotected intercourse" (40.1% vs. 33.7%) but less likely by "12 months of attempting pregnancy" (14.3% vs. 21.8%) and "visiting a doctor for help getting pregnant" (8.4% vs. 19.7%). After unprotected intercourse for 12 months, 36.1% of women who were attempting pregnancy spontaneously conceived by 6 months compared with 13.5% of women who were not attempting pregnancy. While our results for most infertility definitions were similar to those of Marchbanks et al., prevalence estimates continued to differ across demographic groups by definition. © The Author(s) 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Effectiveness of Transdermal Opioid in the Management Multiple Rib Fractures: Randomized Clinical Trial

Directory of Open Access Journals (Sweden)

Okan Solak

2013-09-01

Full Text Available Background: The most commonly observed pathology in chest traumas is rib fracture, and the most important clinical symptom is severe pain. Aims: To investigate the effectiveness of intramuscular opioid (IMO, intravenous patient-controlled analgesia (IVPCA and the Fentanyl transdermal therapeutic system (TTS in the management of rib fracture pain. Study Design: Prospective randomized clinical trial. Methods: In our prospective and randomised study, we included 45 patients with a diagnosis of multiple rib fractures. There were three groups and intercostal nerve blockage (ICB in the first day and oral paracetamol for five days was administered to each group as standard. In Group IMO (n=15, 4x40 mg pethidine HCl was administered to the patients, while in Group IVPCA (n=15 this was 5 µg/mL continuous intravenous fentanyl and was 50 µg fentanyl TTS in Group TTS (n=15. The demographics, injury data and vital signs of the patients were recorded. Pain was scored using Visual Analogue Scale (VAS. The pain during lying down (VASl and mobilisation (VASm was detected. Results: There were no differences between the three groups regarding age, sex, the trauma pattern, the number and distribution of costal fracture localisations, the presence of additional pathology, complications, thoracal catheter and the duration of thoracal catheter. No significant difference between the groups regarding systolic and diastolic arterial tension, number of breaths and beats in a minute was observed (p>0.05. We observed an improvement in the mean VAS score after treatment in all three groups. The mean VASl score significantly decreased after treatment in each group (p0.05. Conclusion: In the analgesia of patients with multiple rib fractures, TTS administration with ICB showed similar effectiveness with IVPCA administration with ICB. In the management of pain due to multiple rib fractures, TTS administration is a safe, non-invasive and effective procedure.

The effectiveness of transdermal opioid in the management multiple rib fractures: randomized clinical trial.

Science.gov (United States)

Solak, Okan; Oz, Gürhan; Kokulu, Serdar; Solak, Ozlem; Doğan, Gökçen; Esme, Hıdır; Ocalan, Kubilay; Baki, Elif Doğan

2013-09-01

The most commonly observed pathology in chest traumas is rib fracture, and the most important clinical symptom is severe pain. To investigate the effectiveness of intramuscular opioid (IMO), intravenous patient-controlled analgesia (IVPCA) and the Fentanyl transdermal therapeutic system (TTS) in the management of rib fracture pain. Prospective randomized clinical trial. In our prospective and randomised study, we included 45 patients with a diagnosis of multiple rib fractures. There were three groups and intercostal nerve blockage (ICB) in the first day and oral paracetamol for five days was administered to each group as standard. In Group IMO (n=15), 4×40 mg pethidine HCl was administered to the patients, while in Group IVPCA (n=15) this was 5 μg/mL continuous intravenous fentanyl and was 50 μg fentanyl TTS in Group TTS (n=15). The demographics, injury data and vital signs of the patients were recorded. Pain was scored using Visual Analogue Scale (VAS). The pain during lying down (VASl) and mobilisation (VASm) was detected. There were no differences between the three groups regarding age, sex, the trauma pattern, the number and distribution of costal fracture localisations, the presence of additional pathology, complications, thoracal catheter and the duration of thoracal catheter. No significant difference between the groups regarding systolic and diastolic arterial tension, number of breaths and beats in a minute was observed (p>0.05). We observed an improvement in the mean VAS score after treatment in all three groups. The mean VASl score significantly decreased after treatment in each group (p0.05). In the analgesia of patients with multiple rib fractures, TTS administration with ICB showed similar effectiveness with IVPCA administration with ICB. In the management of pain due to multiple rib fractures, TTS administration is a safe, non-invasive and effective procedure.

Direct concurrent comparison of multiple pediatric acute asthma scoring instruments.

Science.gov (United States)

Johnson, Michael D; Nkoy, Flory L; Sheng, Xiaoming; Greene, Tom; Stone, Bryan L; Garvin, Jennifer

2017-09-01

Appropriate delivery of Emergency Department (ED) treatment to children with acute asthma requires clinician assessment of acute asthma severity. Various clinical scoring instruments exist to standardize assessment of acute asthma severity in the ED, but their selection remains arbitrary due to few published direct comparisons of their properties. Our objective was to test the feasibility of directly comparing properties of multiple scoring instruments in a pediatric ED. Using a novel approach supported by a composite data collection form, clinicians categorized elements of five scoring instruments before and after initial treatment for 48 patients 2-18 years of age with acute asthma seen at the ED of a tertiary care pediatric hospital ED from August to December 2014. Scoring instruments were compared for inter-rater reliability between clinician types and their ability to predict hospitalization. Inter-rater reliability between clinician types was not different between instruments at any point and was lower (weighted kappa range 0.21-0.55) than values reported elsewhere. Predictive ability of most instruments for hospitalization was higher after treatment than before treatment (p < 0.05) and may vary between instruments after treatment (p = 0.054). We demonstrate the feasibility of comparing multiple clinical scoring instruments simultaneously in ED clinical practice. Scoring instruments had higher predictive ability for hospitalization after treatment than before treatment and may differ in their predictive ability after initial treatment. Definitive conclusions about the best instrument or meaningful comparison between instruments will require a study with a larger sample size.

The use of gaming technology for rehabilitation in people with multiple sclerosis.

Science.gov (United States)

Taylor, M J D; Griffin, M

2015-04-01

Gaming technology - exergaming - is a novel tool to facilitate exercise, improve balance, and encourage rehabilitation training. This review will describe some of the key exergame research to promote physical activity and its use in rehabilitation in other diseases or clinical populations. We will then describe the current state of research in exergaming in people with multiple sclerosis and describe the theories for the mechanism behind some of the improvements in outcomes seen after using exergaming. Lastly, we will identify gaps in the literature and provide directions for future work in this growing area. The current work is contradictory and there is no consensus with regards to training duration/intensity and the outcomes used to assess the clinical effectiveness. This in part is due to the off-the-shelf nature of the games used. A more satisfactory approach would be the development of bespoke games which match a clinical need. Exergames are seen as enjoyable and could be effective in enhancing adherence to rehabilitation. However, the definitive RCT has yet to be carried out comparing exergaming to traditional exercise. © The Author(s), 2014.

Fast nonclinical ventricular tachycardia inducible after ablation in patients with structural heart disease: Definition and clinical implications.

Science.gov (United States)

Watanabe, Masaya; de Riva, Marta; Piers, Sebastiaan R D; Dekkers, Olaf M; Ebert, Micaela; Venlet, Jeroen; Trines, Serge A; Schalij, Martin J; Pijnappels, Daniël A; Zeppenfeld, Katja

2018-01-08

Noninducibility of ventricular tachycardia (VT) with an equal or longer cycle length (CL) than that of the clinical VT is considered the minimum ablation endpoint in patients with structural heart disease. Because their clinical relevance remains unclear, fast nonclinical VTs are often not targeted. However, an accepted definition for fast VT is lacking. The shortest possible CL of a monomorphic reentrant VT is determined by the ventricular refractory period (VRP). The purpose of this study was to propose a patient-specific definition for fast VT based on the individual VRP (fVT VRP ) and assess the prognostic significance of persistent inducibility after ablation of fVT VRP for VT recurrence. Of 191 patients with previous myocardial infarction or with nonischemic cardiomyopathy undergoing VT ablation, 70 (age 63 ± 13 years; 64% ischemic) remained inducible for a nonclinical VT and composed the study population. FVT VRP was defined as any VT with CL ≤VRP 400 + 30 ms. Patients were followed for VT recurrence. After ablation, 30 patients (43%) remained inducible exclusively for fVT VRP and 40 (57%) for any slower VT. Patients with only fVT VRP had 3-year VT-free survival of 64% (95% confidence interval [CI] 46%-82%) compared to 27% (95% CI 14%-48%) for patients with any slower remaining VT (P = .013). Inducibility of only fVT VRP was independently associated with lower VT recurrence (hazard ratio 0.38; 95% CI 0.19-0.86; P = .019). Among 36 patients inducible for any fVT VRP , only 1 had recurrence with fVT VRP . In patients with structural heart disease, inducibility of exclusively fVT VRP after ablation is associated with low VT recurrence. Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Defining progression in nonmuscle invasive bladder cancer: it is time for a new, standard definition

NARCIS (Netherlands)

Lamm, D.; Persad, R.; Brausi, M.; Buckley, R.; Witjes, J.A.; Palou, J.; Bohle, A.; Kamat, A.M.; Colombel, M.; Soloway, M.

2014-01-01

PURPOSE: Despite being one of the most important clinical outcomes in nonmuscle invasive bladder cancer, there is currently no standard definition of disease progression. Major clinical trials and meta-analyses have used varying definitions or have failed to define this end point altogether. A

The establishment of a multiple sclerosis model for clinical MRI study

International Nuclear Information System (INIS)

Zhang Haiqin; Li Kuncheng; Yu Chunshui; Ma Jia; Qin Wen; Ji Zhijuan; Piao Yueshan

2009-01-01

Objective: To establish a rat model of multiple sclerosis (MS) for clinical MRI study. Methods: The Lewis (LEW) rats were immunized by myelin oligodendrocyte glycoprotein peptide 35-55 (MOG 35-55 ) emulsified with complete Freunds adjuvant/incomplete Freunds adjuvant. Twenty LEW rats were selected. Group A rats were 5, group B rats were 10 and control group rats were 5. MRI and histopathology analysis were observed on group A and control group, and clinical course were observed on group B. The clinical course was observed and the brain and spinal cord of EAE rats were scanned on 3.0 T MR system with quadrature wrist joint coil on the third day of the acute stage of disease. The T 2 /T 1 weighted images and Gadolinium enhanced T 1 weighted images in 3D volume were obtained respectively. The magnetization transfer ratio (MTR) images were calculated with special software in workstation. Rats were sacrificed within 24 h after MRI, and the histopathological changes of central nervous system were observed. Results: Twice immunization of MOG 35-55 was used and a rat model of MS was successfully induced with all the rats. The model had varied clinical symptoms. The lesions of central nervous system at acute stage on group A (5 rats) were depicted on MRI. The lesions located in the brain and the spinal cord with main manifestation of hyperintensity on T 2 weighed images and hypointensity on T 1 weighted images. Some lesions had Gd-DTPA enhancement, and the value of MTR decreased. The infiltration of mononuclear cells around blood vessels and the extensive distribution of lesions of demyelination in brain and spinal cord were verified by histological examination. Conclusions: Twice immunization of MOG 35-55 could produce a rat model which mimics MS. The model is stable with higher incidence, and the antigen is cheap and obtained easily. The intravital monitoring of brain and spinal cord lesions in MOG 35-55 induced rat model is possible on 3.0 T clinical whole- body MR

Use of the 2010 McDonald criteria can facilitate early diagnosis of pediatric multiple sclerosis in a predominantly black cohort.

Science.gov (United States)

Williams, Mitchel T; Tapos, Daniela O; Juhász, Csaba

2014-12-01

Pediatric-onset multiple sclerosis represents around 3-5% of all patients with multiple sclerosis. Both the 2005 and 2010 McDonald criteria for multiple sclerosis have been suggested for the possible use in pediatric-onset multiple sclerosis. Modifications incorporated into the 2010 criteria enabled the fulfillment of dissemination in time to be met with the initial magnetic resonance imaging. The present study was designed to compare the diagnostic sensitivity of these criteria at initial presentation, the time to fulfilling them, and secondary effects of ethnicity in pediatric-onset multiple sclerosis. Twenty-five children with clinically definite multiple sclerosis (mean age, 14.6 ± 3.1 years; 15 girls) from a single center between 2005 and 2012 were analyzed using both the 2005 and 2010 McDonald criteria based on initial clinical presentation and neuroimaging findings comparing diagnostic sensitivity, time interval to meet diagnosis, and ethnicity. Initial multiple sclerosis diagnosis rates applying the 2005 McDonald criteria were 32% compared with 92% for the 2010 criteria (P = 0.0003). The mean time after initial signs until the 2005 and 2010 McDonald criteria for multiple sclerosis were met was 5.0 vs 0.7 months, respectively (P = 0.001). Time to diagnosis using the 2010 criteria was shorter in black children than the European white (P = 0.005). The 2010 McDonald criteria are an appropriate tool for the timely diagnosis of pediatric multiple sclerosis, especially in black children, potentially allowing an earlier initiation of disease-modifying therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

Dengue disease outbreak definitions are implicitly variable

Directory of Open Access Journals (Sweden)

Oliver J. Brady

2015-06-01

Full Text Available Infectious diseases rarely exhibit simple dynamics. Outbreaks (defined as excess cases beyond response capabilities have the potential to cause a disproportionately high burden due to overwhelming health care systems. The recommendations of international policy guidelines and research agendas are based on a perceived standardised definition of an outbreak characterised by a prolonged, high-caseload, extra-seasonal surge. In this analysis we apply multiple candidate outbreak definitions to reported dengue case data from Brazil to test this assumption. The methods identify highly heterogeneous outbreak characteristics in terms of frequency, duration and case burden. All definitions identify outbreaks with characteristics that vary over time and space. Further, definitions differ in their timeliness of outbreak onset, and thus may be more or less suitable for early intervention. This raises concerns about the application of current outbreak guidelines for early warning/identification systems. It is clear that quantitatively defining the characteristics of an outbreak is an essential prerequisite for effective reactive response. More work is needed so that definitions of disease outbreaks can take into account the baseline capacities of treatment, surveillance and control. This is essential if outbreak guidelines are to be effective and generalisable across a range of epidemiologically different settings.

Primitive and definitive erythropoiesis in mammals

Directory of Open Access Journals (Sweden)

James ePalis

2014-01-01

Full Text Available Red blood cells (RBCs, which constitute the most abundant cell type in the body, come in two distinct flavors- primitive and definitive. Definitive RBCs in mammals circulate as smaller, anucleate cells during fetal and postnatal life, while primitive RBCs circulate transiently in the early embryo as large, nucleated cells before ultimately enucleating. Both cell types are formed from lineage-committed progenitors that generate a series of morphologically identifiable precursors that enucleate to form mature RBCs. While definitive erythroid precursors mature extravascularly in the fetal liver and postnatal marrow in association with macrophage cells, primitive erythroid precursors mature as a semi-synchronous cohort in the embryonic bloodstream. While the cytoskeletal network is critical for the maintenance of cell shape and the deformability of definitive RBCs, little is known about the components and function of the cytoskeleton in primitive erythroblasts. Erythropoietin (EPO is a critical regulator of late-stage definitive, but not primitive, erythroid progenitor survival. However, recent studies indicate that EPO regulates multiple aspects of terminal maturation of primitive murine and human erythroid precursors, including cell survival, proliferation, and the rate of terminal maturation. Primitive and definitive erythropoiesis share central transcriptional regulators, including Gata1 and Klf1, but are also characterized by the differential expression and function of other regulators, including myb, Sox6, and Bcl11A. Flow cytometry-based methodologies, developed to purify murine and human stage-specific erythroid precursors, have enabled comparative global gene expression studies and are providing new insights into the biology of erythroid maturation.

Comparison of different definitions of feeding intolerance

DEFF Research Database (Denmark)

Reintam Blaser, Annika; Starkopf, Liis; Deane, Adam M

2015-01-01

BACKGROUND & AIMS: While feeding intolerance (FI) is clinically important in the critically ill it is inconsistently defined. By evaluating definitions of FI based on relationships between symptoms and signs of gastrointestinal (GI) dysfunction and mortality the objective was to define FI using...... the definition that was most strongly associated with subsequent mortality. METHODS: Data from all adult patients admitted to a single ICU between 2004 and 2011, and who were receiving enteral nutrition (EN), were analysed. The amount of EN administered, presence of absent bowel sounds (BS), vomiting and....../or regurgitation, diarrhoea, bowel distension, and large gastric residual volumes (GRVs) were documented daily. A GRV ≥500 ml/day was considered as large and the sum of gastrointestinal (GI) symptoms including large GRV was calculated daily. Various definitions of FI were modelled. Definitions using only GRV...

An exploratory trial exploring the use of a multiple intelligences teaching approach (MITA) for teaching clinical skills to first year undergraduate nursing students.

Science.gov (United States)

Sheahan, Linda; While, Alison; Bloomfield, Jacqueline

2015-12-01

The teaching and learning of clinical skills is a key component of nurse education programmes. The clinical competency of pre-registration nursing students has raised questions about the proficiency of teaching strategies for clinical skill acquisition within pre-registration education. This study aimed to test the effectiveness of teaching clinical skills using a multiple intelligences teaching approach (MITA) compared with the conventional teaching approach. A randomised controlled trial was conducted. Participants were randomly allocated to an experimental group (MITA intervention) (n=46) and a control group (conventional teaching) (n=44) to learn clinical skills. Setting was in one Irish third-level educational institution. Participants were all first year nursing students (n=90) in one institution. The experimental group was taught using MITA delivered by the researcher while the control group was taught by a team of six experienced lecturers. Participant preference for learning was measured by the Index of Learning Styles (ILS). Participants' multiple intelligence (MI) preferences were measured with a multiple intelligences development assessment scale (MIDAS). All participants were assessed using the same objective structured clinical examination (OSCE) at the end of semester one and semester two. MI assessment preferences were measured by a multiple intelligences assessment preferences questionnaire. The MITA intervention was evaluated using a questionnaire. The strongest preference on ILS for both groups was the sensing style. The highest MI was interpersonal intelligence. Participants in the experimental group had higher scores in all three OSCEs (pmultiple choice questions as methods of assessment. MITA was evaluated positively. The study findings support the use of MITA for clinical skills teaching and advance the understanding of how MI teaching approaches may be used in nursing education. Copyright © 2015 Elsevier Ltd. All rights reserved.

47 CFR 73.3555 - Multiple ownership.

Science.gov (United States)

2010-10-01

... knowledge of any material involvement of the limited partners, or other interest holders in the case of an... “market,” will be defined by reference to the definition contained in the local television multiple... customers, investment advisors holding stock in their own names for the benefit of clients, and insurance...

Does the applied polytrauma definition notably influence outcome and patient population? - a retrospective analysis.

Science.gov (United States)

Frenzel, Stephan; Krenn, Philipp; Heinz, Thomas; Negrin, Lukas Leopold

2017-08-31

Although the term "polytrauma" has been in use for decades, no generally accepted definition exists. The aim of this study was to demonstrate that different polytrauma definitions applied to a specific patient population result in diverse subgroups of individuals, who in turn present a varying outcome. All patients (≥18 years) treated at our level I trauma center within a time period of three years were classified according to 11 selected polytrauma definitions and included in our study, if they were rated "polytraumatized" by at least one of these definitions. All patients, who met the criteria of a certain definition, were combined to the relevant definition-positive group, thus resulting in 11 patient subgroups. Their demographic data (number of patients, mean patient age, mean Injury Severity Score value, median number of ventilator days, median length of stay at the intensive care unit and at the hospital, mortality rate and odds ratio) were statistically compared. Three hundred seventy-five patients (73% male) with a mean age of 47 years met the inclusion criteria and were allocated to the relevant subgroups; their patient number varied from 55 to 346 and their mean Injury Severity Score value ranged from 4 to 75. Not surprisingly, all examined parameters were subject to variations. Whereas most definition-positive groups showed a mortality rate of about 21% to 30%, 18% of the individuals, who met the criteria according to Blacker, and 40% of the polytrauma victims according to Schalamon died. The Pape 1-, Schalamon-, and Berlin-positive groups presented a significant odds ratio with regard to mortality that considerably exceeded 1. A polytrauma definition can only be a reliable tool in classifying trauma victims if it provides a significant odds ratio with regard to mortality that considerably exceeds 1 and if it succeeds in capturing patients with multiple severe injuries and a higher mortality rate without reducing the number of polytraumatized

Clinical observation of 89Sr treatment efficacy of multiple bone metastases in breast and prostate cancer patients

International Nuclear Information System (INIS)

Yuan Chao; Li Weipeng; Hu Yongquan; Tao Jian

2010-01-01

Objective: To evaluate the efficacy of 89 Sr in treatment of multiple bone metastases of breast and prostate cancer patients. Methods: Seventy multiple bone metastases patients (30 females with breast cancer and 40 males with prostate cancer) were treated with 89 Sr. The clinical effectiveness was assessed by Karnofsky performance score and whole body bone scanning data. Results: The total pain relief rate was 79% in bone metastases of breast cancer and 85% in bone metastases of prostate cancer, respectively. There was no significant differences between the two groups (χ 2 =0.78, P>0.05). The Karnofsky score was significantly improved in both groups (t=2.46, P 89 Sr treatment was good, and the quality of life was improved in patients with multiple bone metastases breast or prostate cancer. (authors)

Clinical vocabulary as a boundary object in multidisciplinary care management of multiple chemical sensitivity, a complex and chronic condition.

Science.gov (United States)

Sampalli, Tara; Shepherd, Michael; Duffy, Jack

2011-04-14

Research has shown that accurate and timely communication between multidisciplinary clinicians involved in the care of complex and chronic health conditions is often challenging. The domain knowledge for these conditions is heterogeneous, with poorly categorized, unstructured, and inconsistent clinical vocabulary. The potential of boundary object as a technique to bridge communication gaps is explored in this study. A standardized and controlled clinical vocabulary was developed as a boundary object in the domain of a complex and chronic health condition, namely, multiple chemical sensitivity, to improve communication among multidisciplinary clinicians. A convenience sample of 100 patients with a diagnosis of multiple chemical sensitivity, nine multidisciplinary clinicians involved in the care of patients with multiple chemical sensitivity, and 36 clinicians in the community participated in the study. Eighty-two percent of the multidisciplinary and inconsistent vocabulary was standardized using the Systematized Nomenclature of Medicine - Clinical Terms (SNOMED(®) CT as a reference terminology. Over 80% of the multidisciplinary clinicians agreed on the overall usefulness of having a controlled vocabulary as a boundary object. Over 65% of clinicians in the community agreed on the overall usefulness of the vocabulary. The results from this study are promising and will be further evaluated in the domain of another complex chronic condition, ie, chronic pain. The study was conducted as a preliminary analysis for developing a boundary object in a heterogeneous domain of knowledge.

[Problems with current hypertension definition in children].

Science.gov (United States)

Peco-Antić, Amira

2008-01-01

The Task Force data have added immeasurably to our understanding of the normal distribution of blood pressure in children. However, the manner in which arterial hypertension is defined in children is not without problems. The main problem is that the current definition of hypertension in children is not based on the end-organ damage assessment, but on the blood pressure height-related percentile distribution of healthy reference population. This could be overcome by introducing the relationship of blood pressure values with sensitive markers of hypertensive sequelae (such as carotid intimal-medial thickness, left ventricle mass index, retinal arteriolar narrowing and arteriovenous nicking as well as microalbumin urinary excretion) to define better the specific blood pressure values with outcomes. Furthermore, the current definition of hypertension based on the demographic and clinical characteristics of the reference population does not consider the normal evolution of reference population, as well as its ethnic differences. In addition, being based on the single occasion measurement in quite position it does not account for the possibility of transient, stress induced elevations in blood pressure known as white coat hypertension. Therefore, incorporation ambulatory 24 h blood pressure data into the definition of arterial hypertension in children may increase the definition reliability for clinical decision - making, although for such reliability the paediatric normative ambulatory blood pressure data should be improved.

Lesion classification using clinical and visual data fusion by multiple kernel learning

Science.gov (United States)

Kisilev, Pavel; Hashoul, Sharbell; Walach, Eugene; Tzadok, Asaf

2014-03-01

To overcome operator dependency and to increase diagnosis accuracy in breast ultrasound (US), a lot of effort has been devoted to developing computer-aided diagnosis (CAD) systems for breast cancer detection and classification. Unfortunately, the efficacy of such CAD systems is limited since they rely on correct automatic lesions detection and localization, and on robustness of features computed based on the detected areas. In this paper we propose a new approach to boost the performance of a Machine Learning based CAD system, by combining visual and clinical data from patient files. We compute a set of visual features from breast ultrasound images, and construct the textual descriptor of patients by extracting relevant keywords from patients' clinical data files. We then use the Multiple Kernel Learning (MKL) framework to train SVM based classifier to discriminate between benign and malignant cases. We investigate different types of data fusion methods, namely, early, late, and intermediate (MKL-based) fusion. Our database consists of 408 patient cases, each containing US images, textual description of complaints and symptoms filled by physicians, and confirmed diagnoses. We show experimentally that the proposed MKL-based approach is superior to other classification methods. Even though the clinical data is very sparse and noisy, its MKL-based fusion with visual features yields significant improvement of the classification accuracy, as compared to the image features only based classifier.

Linked Clinical Trials – The Development of New Clinical Learning Studies in Parkinson’s Disease Using Screening of Multiple Prospective New Treatments

Science.gov (United States)

Brundin, Patrik; Barker, Roger A.; Conn, P. Jeffrey; Dawson, Ted M.; Kieburtz, Karl; Lees, Andrew J.; Schwarzschild, Michael A.; Tanner, Caroline M.; Isaacs, Tom; Duffen, Joy; Matthews, Helen; Wyse, Richard K.H.

2015-01-01

Finding new therapies for Parkinson’s disease (PD) is a slow process. We assembled an international committee of experts to examine drugs potentially suitable for repurposing to modify PD progression. This committee evaluated multiple drugs currently used, or being developed, in other therapeutic areas, as well as considering several natural, non-pharmaceutical compounds. The committee prioritized which of these putative treatments were most suited to move immediately into pilot clinical trials. Aspects considered included known modes of action, safety, blood-brain-barrier penetration, preclinical data in animal models of PD and the possibility to monitor target engagement in the brain. Of the 26 potential interventions, 10 were considered worth moving forward into small, parallel ‘learning’ clinical trials in PD patients. These trials could be funded in a multitude of ways through support from industry, research grants and directed philanthropic donations. The committee-based approach to select the candidate compounds might help rapidly identify new potential PD treatment strategies for use in clinical trials. PMID:24018336

Interferon Treatment of Multiple Sclerosis

OpenAIRE

Alajbegovic, Azra; Deljo, Dervis; Alajbegovic, Salem; Djelilovic-Vranic, Jasminka; Todorovic, Ljubica; Tiric-Campara, Merita

2012-01-01

Introduction: In the treatment of Multiple Sclerosis (MS) differ: treatment of relapse, treatment slow the progression of the disease (immunomodulators and immunosuppression), and symptomatic treatment. The aim: The aim of this study is to analyze the application of interferon therapy in the treatment of MS-E: Process the disease, patients with multiple sclerosis who have passed the commission for multiple sclerosis at the Neurology Clinic of Clinical Center of Sarajevo University as a refere...

A Comprehensive Definition for Integrative Oncology.

Science.gov (United States)

Witt, Claudia M; Balneaves, Lynda G; Cardoso, Maria J; Cohen, Lorenzo; Greenlee, Heather; Johnstone, Peter; Kücük, Ömer; Mailman, Josh; Mao, Jun J

2017-11-01

Integrative oncology, which is generally understood to refer to the use of a combination of complementary medicine therapies in conjunction with conventional cancer treatments, has been defined in different ways, but there is no widely accepted definition. We sought to develop and establish a consensus for a comprehensive definition of the field of integrative oncology. We used a mixed-methods approach that included a literature analysis and a consensus procedure, including an interdisciplinary expert panel and surveys, to develop a comprehensive and acceptable definition for the term "integrative oncology." The themes identified in the literature and from the expert discussion were condensed into a two-sentence definition. Survey respondents had very positive views on the draft definition, and their comments helped to shape the final version. The final definition for integrative oncology is: "Integrative oncology is a patient-centered, evidence-informed field of cancer care that utilizes mind and body practices, natural products, and/or lifestyle modifications from different traditions alongside conventional cancer treatments. Integrative oncology aims to optimize health, quality of life, and clinical outcomes across the cancer care continuum and to empower people to prevent cancer and become active participants before,during, and beyond cancer treatment." This short and comprehensive definition for the term integrative oncology will facilitate a better understanding and communication of this emerging field. This definition will also drive focused and cohesive effort to advance the field of integrative oncology. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Common Ground? The Concordance of Sarcopenia and Frailty Definitions

NARCIS (Netherlands)

Reijnierse, Esmee M.; Trappenburg, Marijke C.; Blauw, Gerard Jan; Verlaan, Sjors; de van der Schueren, Marian A.E.; Meskers, Carel G.M.; Maier, Andrea B.

2016-01-01

Objectives: This study aimed to explore the concordance between definitions of sarcopenia and frailty in a clinically relevant population of geriatric outpatients. Design: Data were retrieved from a cross-sectional study. Setting: The study was performed in a geriatric outpatient clinic of a

[Cormorbidity in multiple sclerosis and its therapeutic approach].

Science.gov (United States)

Estruch, Bonaventura Casanova

2014-12-01

Multiple sclerosis (MS) is a long-term chronic disease, in which intercurrent processes develop three times more frequently in affected individuals than in persons without MS. Knowledge of the comorbidity of MS, its definition and measurement (Charlson index) improves patient management. Acting on comorbid conditions delays the progression of disability, which is intimately linked to the number of concurrent processes and with health states and habits. Moreover, the presence of comorbidities delays the diagnosis of MS, which in turn delays the start of treatment. The main comorbidity found in MS includes other autoimmune diseases (thyroiditis, systemic lupus erythematosus, or pemphigus) but can also include general diseases, such as asthma or osteomuscular alterations, and, in particular, psychiatric disturbances. All these alterations should be evaluated with multidimensional scales (Disability Expectancy Table, DET), which allow more accurate determination of the patient's real clinical course and quality of life. These scales also allow identification of how MS, concurrent and intercurrent processes occurring during the clinical course, and the treatment provided affect patients with MS. An overall approach to patients' health status helps to improve quality of life. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Privacy Protection on Multiple Sensitive Attributes

Science.gov (United States)

Li, Zhen; Ye, Xiaojun

In recent years, a privacy model called k-anonymity has gained popularity in the microdata releasing. As the microdata may contain multiple sensitive attributes about an individual, the protection of multiple sensitive attributes has become an important problem. Different from the existing models of single sensitive attribute, extra associations among multiple sensitive attributes should be invested. Two kinds of disclosure scenarios may happen because of logical associations. The Q&S Diversity is checked to prevent the foregoing disclosure risks, with an α Requirement definition used to ensure the diversity requirement. At last, a two-step greedy generalization algorithm is used to carry out the multiple sensitive attributes processing which deal with quasi-identifiers and sensitive attributes respectively. We reduce the overall distortion by the measure of Masking SA.

Taylor spatial frame fixation in patients with multiple traumatic injuries: study of 57 long-bone fractures.

Science.gov (United States)

Sala, Francesco; Elbatrawy, Yasser; Thabet, Ahmed M; Zayed, Mahmoud; Capitani, Dario

2013-08-01

To evaluate the Taylor spatial frame (TSF) for primary and definitive fixation of lower limb long-bone fractures in patients with multiple traumatic injuries. Retrospective. Level I trauma center. Consecutive series of 52 patients, 57 fractures (25 femoral and 32 tibial), treated between 2005 and 2009. Forty-nine fractures (86%) were open. Injury Severity Score ≥16 for all patients. Fifty-four fractures (95%) underwent definitive fixation with the TSF and 3 were treated primarily within 48 hours of injury. In 22 cases (39%), fractures were acutely reduced with the TSF, fixed to bone and the struts in sliding mode without further adjustment, and in 35 cases (61%), the total residual deformity correction program was undertaken. Clinical and radiological. Complete union was obtained in 52 fractures (91%) without additional surgery at an average of 29 weeks. Four nonunions and 1 delayed union occurred. Results based on Association for the Study and Application of the Method of Ilizarov criteria: 74% excellent, 16% good, 4% fair, and 7% poor for bone outcomes and 35% excellent, 47% good, and 18% fair for functional outcomes. Eighty-eight percent of patients returned to preinjury work activities. Primary and definitive fixation with the TSF is effective. Advantages include continuity of device until union, reduced risk of infection, early mobilization, restoration of primary defect caused by bone loss, easy and accurate application, convertibility and versatility compared with a monolateral fixator, and improved union rate and range of motion for lower extremity long-bone fractures in patients with multiple traumatic injuries.

Critical thinking versus clinical reasoning versus clinical judgment: differential diagnosis.

Science.gov (United States)

Victor-Chmil, Joyce

2013-01-01

Concepts of critical thinking, clinical reasoning, and clinical judgment are often used interchangeably. However, they are not one and the same, and understanding subtle difference among them is important. Following a review of the literature for definitions and uses of the terms, the author provides a summary focused on similarities and differences in the processes of critical thinking, clinical reasoning, and clinical judgment and notes suggested methods of measuring each.

Coronaviruses in brain tissue from patients with multiple sclerosis

DEFF Research Database (Denmark)

Dessau, R B; Lisby, G; Frederiksen, J L

2001-01-01

Brain tissue from 25 patients with clinically definite multiple sclerosis (MS) and as controls brain tissue from 36 patients without neurological disease was tested for the presence of human coronaviral RNA. Four PCR assays with primers specific for N-protein of human coronavirus strain 229E...... and three PCR assays with primers specific for the nucleocapsid protein of human coronavirus strain OC43 were performed. Sporadic positive PCR assays were observed in both patients and controls in some of the PCR assays. However, these results were not reproducible and there was no difference...... in the proportion of positive signals from the MS patients compared to controls. Evidence for a chronic infection with the human coronaviruses strain 229E or OC43 in brain tissue from patients with MS or controls has not been found in this study....

Definition of neutron multiplication in a reception capacity of radioactive waste shop

International Nuclear Information System (INIS)

Dulin, V.A.; Dulin, V.V.; Pavlova, O.N.

2006-01-01

To determine neutrons multiplication the measurements and calculations of spatial distributions of neutron counting and absolute fission rates in a reception capacity of IPPE radioactive waste shop have been carried out and analyzed. A content of fissionable medium was unknown. The approach developed has allowed implementing a calculation analysis of the experimental data on determination of the most probable spatial distributions of basic parameters of the fissionable medium of unknown content. It has allowed determining the neutrons multiplication factor in a reception capacity of a tank No. 17. It has been found that the value of neutrons multiplication factor in a tank is 1.07 ± 0.03. The developed measurement method and calculation analysis used for experimental data also can be applied in other cases when the multiplication medium content is unknown [ru

Central Hyperexcitability in Chronic Musculoskeletal Pain: A Conceptual Breakthrough with Multiple Clinical Implications

Directory of Open Access Journals (Sweden)

Jan Lidbeck

2002-01-01

Full Text Available Recent investigations of dysfunctional pain processing in the central nervous system have contributed much knowledge about the development of chronic musculoskeletal pain. Many common chronic musculoskeletal pain syndromes - including regional myofascial pain syndromes, whiplash pain syndromes, refractory work-related neck-shoulder pain, certain types of chronic low back pain, fibromyalgia and others - may essentially be explained by abnormalities in central pain modulation. The growing awareness of dysfunctional central pain modulation may be a conceptual breakthrough leading to a better understanding of common chronic pain disorders. A new paradigm will have multiple clinical implications, including re-evaluation of clinical practice routines and rehabilitation methods, and will focus on controversial issues of medicolegal concern. The concept of dysfunctional central pain processing will also necessitate a mechanism-based classification of pain for the selection of individual treatment and rehabilitation programs for subgroups of patients with chronic musculoskeletal pain due to different pathophysiological mechanisms.

Influence of Disease and Patient Characteristics on Daratumumab Exposure and Clinical Outcomes in Relapsed or Refractory Multiple Myeloma

DEFF Research Database (Denmark)

Yan, Xiaoyu; Clemens, Pamela L; Puchalski, Thomas

2018-01-01

OBJECTIVE: The aim of this study was to understand the influence of disease and patient characteristics on exposure to daratumumab, an immunoglobulin Gκ (IgGκ) monoclonal antibody, and clinical outcomes in relapsed or refractory multiple myeloma (MM). PATIENTS AND METHODS: Baseline myeloma type, ...

A simple transformation independent method for outlier definition.

Science.gov (United States)

Johansen, Martin Berg; Christensen, Peter Astrup

2018-04-10

Definition and elimination of outliers is a key element for medical laboratories establishing or verifying reference intervals (RIs). Especially as inclusion of just a few outlying observations may seriously affect the determination of the reference limits. Many methods have been developed for definition of outliers. Several of these methods are developed for the normal distribution and often data require transformation before outlier elimination. We have developed a non-parametric transformation independent outlier definition. The new method relies on drawing reproducible histograms. This is done by using defined bin sizes above and below the median. The method is compared to the method recommended by CLSI/IFCC, which uses Box-Cox transformation (BCT) and Tukey's fences for outlier definition. The comparison is done on eight simulated distributions and an indirect clinical datasets. The comparison on simulated distributions shows that without outliers added the recommended method in general defines fewer outliers. However, when outliers are added on one side the proposed method often produces better results. With outliers on both sides the methods are equally good. Furthermore, it is found that the presence of outliers affects the BCT, and subsequently affects the determined limits of current recommended methods. This is especially seen in skewed distributions. The proposed outlier definition reproduced current RI limits on clinical data containing outliers. We find our simple transformation independent outlier detection method as good as or better than the currently recommended methods.

Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome and healthy control participants: study protocol for an exploratory randomized double- blind placebo-controlled trial.

LENUS (Irish Health Repository)

O'Connell, Karen

2013-08-01

There is increasing evidence linking vitamin D deficiency to both susceptibility to, and severity of, multiple sclerosis (MS). Patients with the clinically isolated syndrome represent the initial presentation of a demyelinating disorder, and those with asymptomatic lesions on magnetic resonance imaging (MRI) are at risk of progression to clinically definite MS. The aims of this study are to examine the immunologic effects of vitamin D in both healthy individuals and in patients with clinically isolated syndrome, and in the latter group the effects on disease progression assessed by MRI and clinical measures.

Clinical relevance in anesthesia journals

DEFF Research Database (Denmark)

Lauritsen, Jakob; Møller, Ann M

2006-01-01

The purpose of this review is to present the latest knowledge and research on the definition and distribution of clinically relevant articles in anesthesia journals. It will also discuss the importance of the chosen methodology and outcome of articles.......The purpose of this review is to present the latest knowledge and research on the definition and distribution of clinically relevant articles in anesthesia journals. It will also discuss the importance of the chosen methodology and outcome of articles....

Child Emotional Aggression and Abuse: Definitions and Prevalence

Science.gov (United States)

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

2011-01-01

Objective: Research on and intervention for child emotional abuse and emotional aggression toward children have been severely hampered because there have been no agreed-upon, clinically usable definitions. Methods: We have (a) proposed and field-tested a set of criteria to operationally define child emotional abuse for clinical settings and (b)…

Definition and classification of negative motor signs in childhood.

Science.gov (United States)

Sanger, Terence D; Chen, Daofen; Delgado, Mauricio R; Gaebler-Spira, Deborah; Hallett, Mark; Mink, Jonathan W

2006-11-01

In this report we describe the outcome of a consensus meeting that occurred at the National Institutes of Health in Bethesda, Maryland, March 12 through 14, 2005. The meeting brought together 39 specialists from multiple clinical and research disciplines including developmental pediatrics, neurology, neurosurgery, orthopedic surgery, physical therapy, occupational therapy, physical medicine and rehabilitation, neurophysiology, muscle physiology, motor control, and biomechanics. The purpose of the meeting was to establish terminology and definitions for 4 aspects of motor disorders that occur in children: weakness, reduced selective motor control, ataxia, and deficits of praxis. The purpose of the definitions is to assist communication between clinicians, select homogeneous groups of children for clinical research trials, facilitate the development of rating scales to assess improvement or deterioration with time, and eventually to better match individual children with specific therapies. "Weakness" is defined as the inability to generate normal voluntary force in a muscle or normal voluntary torque about a joint. "Reduced selective motor control" is defined as the impaired ability to isolate the activation of muscles in a selected pattern in response to demands of a voluntary posture or movement. "Ataxia" is defined as an inability to generate a normal or expected voluntary movement trajectory that cannot be attributed to weakness or involuntary muscle activity about the affected joints. "Apraxia" is defined as an impairment in the ability to accomplish previously learned and performed complex motor actions that is not explained by ataxia, reduced selective motor control, weakness, or involuntary motor activity. "Developmental dyspraxia" is defined as a failure to have ever acquired the ability to perform age-appropriate complex motor actions that is not explained by the presence of inadequate demonstration or practice, ataxia, reduced selective motor control

Comparison of different criteria for periodontitis case definition in head and neck cancer individuals.

Science.gov (United States)

Bueno, Audrey Cristina; Ferreira, Raquel Conceição; Cota, Luis Otávio Miranda; Silva, Guilherme Carvalho; Magalhães, Cláudia Silami; Moreira, Allyson Nogueira

2015-09-01

Different periodontitis case definitions have been used in clinical research and epidemiology. The aim of this study was to determine more accurate criterion for the definition of mild and moderate periodontitis case to be applied to head and neck cancer individuals before radiotherapy. The frequency of periodontitis in a sample of 84 individuals was determined according to different diagnostic criteria: (1) Lopez et al. (2002);(2) Hujoel et al. (2006); (3) Beck et al. (1990); (4) Machtei et al. (1992); (5) Tonetti and Claffey (2005); (6) and Page and Eke (2007). All diagnosis were based on the clinical parameters obtained by a single calibrated examiner (Kw = 0.71). The individuals were evaluated before radiotherapy. They received oral hygiene instructions, and the cases diagnosed with periodontitis (Page and Eke 2007) were treated. The gold standard was the definition 6, and the others were compared by means of agreement, sensitivity (SS), specificity (SP), and the area under ROC curve. The kappa test evaluated the agreement between definitions. The frequency of periodontitis at baseline was 53.6 % (definition 1), 81.0 % (definition 2), 40.5 % (definition 3), 26.2 % (definition 4), 13.1 % (definition 5), and 70.2 % (definition 6). The kappa test showed a moderate agreement between definitions 6 and 2 (59.0 %) and definitions 6 and 1 (56.0 %). The criterion with higher SS (0.92) and SP (0.73) was definition 1. Definition 1 was the most accurate criterion to case periodontitis definition to be applied to head and neck cancer individuals.

Hypoglycemia: a review of definitions used in clinical trials evaluating antihyperglycemic drugs for diabetes

Directory of Open Access Journals (Sweden)

Balijepalli C

2017-05-01

Full Text Available Chakrapani Balijepalli,1,2 Eric Druyts,2 Gaye Siliman,2 Michel Joffres,1 Kristian Thorlund,2,3 Edward J Mills3 1Faculty of Health Sciences, Simon Fraser University, Burnaby, 2Precision Health Economics, Vancouver, BC, 3Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada Objective: To understand the severity and potential impact of heterogeneity in definitions of hypoglycemia used in diabetes research, we aimed to review the hypoglycemia definitions adopted in randomized controlled trials (RCTs.Methods: We reviewed 109 RCTs included in the Canadian Agency for Drugs and Technologies in Health reports for the second- and third-line therapy for the patients with type 2 diabetes (T2D.Results: Nearly 60% (n=66 of the studies reviewed presented the definitions for overall hypoglycemia, and another 20% (n=22 of the studies reported the results for hypoglycemia but did not report a definition. Among these 66 studies, only 9 (14% followed the American Diabetes Association/European Medicines Agency specified guidelines to define hypoglycemia, with an exact threshold of plasma glucose ≤3.9 mmol/L. Fifty-two of the 66 studies (79% used a threshold considerably lower than the recommended ≤3.9 mmol/L, and 16 studies used a threshold between 3.8 and 4.0 mmol/L. The proportion of the trials that used a cutoff value of <3.1 mmol/L appeared to be slightly similar among the more commonly used non-insulin treatments, GLP-1s (7 of 18 [39%], thiazolidinediones (TZDs; 6 of 11 [55%], DPP-4s (12 of 19 [64%], and sulfonylureas (11 of 20 [55%]. Among trials with intermediate-long-acting insulins (neutral protamine Hagedorn insulin, detemir, glargine, 7 of 26 trials (27% used a cutoff of <3.1 mmol/L. The definition of severe hypoglycemia was also subject to substantial heterogeneity, in both the utilized threshold and accompanying soft definitions.Conclusion: This review demonstrates

Primary hyperoxaluria: spectrum of clinical and imaging findings

Energy Technology Data Exchange (ETDEWEB)

Strauss, Sara B.; Levin, Terry L. [Children' s Hospital of Montefiore Medical Center, Division of Pediatric Radiology, Department of Radiology, Bronx, NY (United States); Waltuch, Temima; Kaskel, Frederick [Children' s Hospital at Montefiore Medical Center, Division of Pediatric Nephrology, Bronx, NY (United States); Bivin, William [Allegheny General Hospital, Department of Pathology, Pittsburgh, PA (United States)

2017-01-15

Primary hyperoxaluria is a rare autosomal recessive inborn error of metabolism with three known subtypes. In primary hyperoxaluria type 1, the most common of the subtypes, a deficiency in the hepatic enzymes responsible for the metabolism of glycoxylate to glycine, leads to excessive levels of glyoxylate, which is converted to oxalate. The resultant elevation in serum and urinary oxalate that characterizes primary hyperoxaluria leads to calcium oxalate crystal deposition in multiple organ systems (oxalosis). We review the genetics, pathogenesis, variable clinical presentation and course of this disease as well as its treatment. Emphasis is placed on the characteristic imaging findings before and after definitive treatment with combined liver and renal transplantation. (orig.)

Cassandra the definitive guide

CERN Document Server

Hewitt, Eben

2011-01-01

What could you do with data if scalability wasn't a problem? With this hands-on guide, you'll learn how Apache Cassandra handles hundreds of terabytes of data while remaining highly available across multiple data centers -- capabilities that have attracted Facebook, Twitter, and other data-intensive companies. Cassandra: The Definitive Guide provides the technical details and practical examples you need to assess this database management system and put it to work in a production environment. Author Eben Hewitt demonstrates the advantages of Cassandra's nonrelational design, and pays special

Classification Systems for Individual Differences in Multiple-task Performance and Subjective Estimates of Workload

Science.gov (United States)

Damos, D. L.

1984-01-01

Human factors practitioners often are concerned with mental workload in multiple-task situations. Investigations of these situations have demonstrated repeatedly that individuals differ in their subjective estimates of workload. These differences may be attributed in part to individual differences in definitions of workload. However, after allowing for differences in the definition of workload, there are still unexplained individual differences in workload ratings. The relation between individual differences in multiple-task performance, subjective estimates of workload, information processing abilities, and the Type A personality trait were examined.

Particle multiplicity in jets and subjets with jet axis from color current

International Nuclear Information System (INIS)

Ochs, Wolfgang; Ramos, Redamy Perez

2008-01-01

We study the particle multiplicity in a jet or subjet as derived from an energy-multiplicity 2-particle correlation. This definition avoids the notion of a globally fixed jet axis and allows for the study of smaller jet cone openings in a more stable way. The results are sensitive to the mean color current A 0 in the jet from primary parton A 0 , which takes into account intermediate partonic processes in the subjet production where C F A 0 c at high energies. We generalize previous calculations in the leading logarithmic approximation (LLA). The size of the effects related to this jet axis definition is computed for multiplicities in subjets with different opening angles and energies by including contributions from the modified LLA and next-to-modified LLA to the leading order QCD results.

The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material.

Science.gov (United States)

Ferguson, Niall D; Fan, Eddy; Camporota, Luigi; Antonelli, Massimo; Anzueto, Antonio; Beale, Richard; Brochard, Laurent; Brower, Roy; Esteban, Andrés; Gattinoni, Luciano; Rhodes, Andrew; Slutsky, Arthur S; Vincent, Jean-Louis; Rubenfeld, Gordon D; Thompson, B Taylor; Ranieri, V Marco

2012-10-01

Our objective was to revise the definition of acute respiratory distress syndrome (ARDS) using a conceptual model incorporating reliability and validity, and a novel iterative approach with formal evaluation of the definition. The European Society of Intensive Care Medicine identified three chairs with broad expertise in ARDS who selected the participants and created the agenda. After 2 days of consensus discussions a draft definition was developed, which then underwent empiric evaluation followed by consensus revision. The Berlin Definition of ARDS maintains a link to prior definitions with diagnostic criteria of timing, chest imaging, origin of edema, and hypoxemia. Patients may have ARDS if the onset is within 1 week of a known clinical insult or new/worsening respiratory symptoms. For the bilateral opacities on chest radiograph criterion, a reference set of chest radiographs has been developed to enhance inter-observer reliability. The pulmonary artery wedge pressure criterion for hydrostatic edema was removed, and illustrative vignettes were created to guide judgments about the primary cause of respiratory failure. If no risk factor for ARDS is apparent, however, objective evaluation (e.g., echocardiography) is required to help rule out hydrostatic edema. A minimum level of positive end-expiratory pressure and mutually exclusive PaO(2)/FiO(2) thresholds were chosen for the different levels of ARDS severity (mild, moderate, severe) to better categorize patients with different outcomes and potential responses to therapy. This panel addressed some of the limitations of the prior ARDS definition by incorporating current data, physiologic concepts, and clinical trials results to develop the Berlin definition, which should facilitate case recognition and better match treatment options to severity in both research trials and clinical practice.

PSEUDOTUMORAL FORM OF MULTIPLE SCLEROSIS WITH SYMPTOMATIC CONVULSIVE SEIZURES (A CLINICAL CASE

Directory of Open Access Journals (Sweden)

Yu. A. Belova

2015-01-01

Full Text Available Multiple sclerosis (MS is prominent among central nervous system diseases. It affects chiefly young people and almost inevitably results in disability. In the past decade, there has been an upward trend for the prevalence of MS worldwide; in particular, the higher prevalence of this disease has been registered in the Moscow Region, which is associated with both an objective increase in its morbidity and improvement of specialized care to the population in the region. MS is characterized by a variety of clinical manifestations. However, paroxysmal disturbances are referred to as the rare symptoms of MS: the incidence of epileptic seizures in this condition is 0.89 to 7.5% according to the literature data. In addition to the clinical form of MS, there are its rare malignant atypical forms that also include its pseudotumoral form characterized by intrinsic neuroimaging and clinical signs that are different from the classical form of MS and another abnormality of the central nervous system. The pseudotumoral form of MS is characterized by the development of acute focal demyelination that appears as a large focus of an increased magnetic resonance signal with perifocal edema as evidenced by magnetic resonance imaging. A pseudotumoral focus of demyelination can occur both at the onset of MS and during its recurrent course. The atypical onset of MS is a special challenge because of diagnostic problems, which may lead to erroneous therapeutic policy and have a negative impact on the late prognosis of the disease. The authors provide a clinical case of the pseudotumoral form of MS with convulsive seizures at the onset of demyelinating disease. The problems of diagnosis and therapeutic approaches are discussed.

Multiple exostotic hypochondroplasia: Syndrome of combined hypochondroplasia and multiple exostoses

International Nuclear Information System (INIS)

Dominguez, R.; Young, L.W.; Girdany, B.R.; Steele, M.W.

1984-01-01

This is a report of a family with major focus on the daughter who had short stature. The mother had hypochondroplasia and the father had multiple exostoses. The daughter's skeletal roentgenograms show features of both hypochondroplasia and multiple exostoses. The roentgenographic, clinical and genetic aspects of these skeletal dysplasias are reviewed and hypochrondroplasia is contrasted with achondroplasia. The genetic and counseling implications of the association of hypochondroplasia and multiple exostoses are discussed. (orig.)

Multiple exostotic hypochondroplasia: Syndrome of combined hypochondroplasia and multiple exostoses

Energy Technology Data Exchange (ETDEWEB)

Dominguez, R.; Young, L.W.; Girdany, B.R.; Steele, M.W.

1984-07-01

This is a report of a family with major focus on the daughter who had short stature. The mother had hypochondroplasia and the father had multiple exostoses. The daughter's skeletal roentgenograms show features of both hypochondroplasia and multiple exostoses. The roentgenographic, clinical and genetic aspects of these skeletal dysplasias are reviewed and hypochrondroplasia is contrasted with achondroplasia. The genetic and counseling implications of the association of hypochondroplasia and multiple exostoses are discussed.

SU-F-T-637: Single-Isocenter Versus Multiple-Isocenter VMAT SRS for Unusual Multiple Metastasis Case with Two Widely Separated Lesions

Energy Technology Data Exchange (ETDEWEB)

Thomas, EM; Popple, RA; Fiveash, JB [The University of Alabama at Birmingham, Birmingham, AL (United States)

2016-06-15

Purpose: Single-isocenter (SI) volumetric modulated arc therapy has been shown to be an effective and efficient approach to multiple metastasis radiosurgery. However, certain extreme cases raise the question of whether multiple-isocenter (MI) approaches can still generate superior plans. In this study, we ask this question with respect to a clinical case with two very widely separated lesions. Methods: A patient with two widely separated (d = 12cm) tumors was treated with SI-VMAT SRS using 10MV flattening filter free (FFF) beam with high-definition multi-leaf collimator (HD-MLC, 2.5/5mm) in two non-coplanar arcs using concentric rings to enforce steep gradient. Because of lesion positioning with respect to collimator angle selection, lesions were treated by 5mm leaves. We re-planned the case with a congruent arc arrangement but separate isocenter for each lesion. In this manner, lesions were treated by 2.5mm leaves. Conformity index (CI), V50%, and mean brain dose were compared. Results: Neither conformity (CI-SI = 1.12, CI-MI = 1.08) nor V50% (V50%-SI =8.82cc, V50%-MI =8.81cc) were improved by utilizing a separate isocenter for each lesion. Mean brain dose was slightly reduced (dmean-SI = 118.4 cGy, dmean-MI = 88.7 cGy) by using multiple isocenters. Conclusion: For this case with a lesion at the apex of the brain and another distantly located at the base of skull, employing a separate isocenter for each target did not meaningfully improve plan quality. Single-isocenter VMAT has been shown feasible and equivalent to multiple-isocenter VMAT for multiple metastasis cases in general. In this extreme case, single- and multiple- isocenter VMAT were also equivalent. If rotational setup errors are appropriately corrected, the increased delivery efficiency of the single-isocenter approach renders it preferable to the multiple isocenter approach. Dr’s Thomas, Popple, and Fiveash have all received honoraria from Varian Medical Systems for discussing their experiences with

Deliberate teaching tools for clinical teaching encounters: A critical scoping review and thematic analysis to establish definitional clarity.

Science.gov (United States)

Sidhu, Navdeep S; Edwards, Morgan

2018-04-27

We conducted a scoping review of tools designed to add structure to clinical teaching, with a thematic analysis to establish definitional clarity. Six thousand and forty nine citations were screened, 434 reviewed for eligibility, and 230 identified as meeting study inclusion criteria. Eighty-nine names and 51 definitions were identified. Based on a post facto thematic analysis, we propose that these tools be named "deliberate teaching tools" (DTTs) and defined as "frameworks that enable clinicians to have a purposeful and considered approach to teaching encounters by incorporating elements identified with good teaching practice." We identified 46 DTTs in the literature, with 38 (82.6%) originally described for the medical setting. Forty justification articles consisted of 16 feedback surveys, 13 controlled trials, seven pre-post intervention studies with no control group, and four observation studies. Current evidence of efficacy is not entirely conclusive, and many studies contain methodology flaws. Forty-nine clarification articles comprised 12 systematic reviews and 37 narrative reviews. The most number of DTTs described by any review was four. A common design theme was identified in approximately three-quarters of DTTs. Applicability of DTTs to specific alternate settings should be considered in context, and appropriately designed justification studies are warranted to demonstrate efficacy.

Product/Service-System Origins and Trajectories: A Systematic Literature Review of PSS Definitions and their Characteristics

DEFF Research Database (Denmark)

Haase, Ronja P.; Pigosso, Daniela Cristina Antelmi; McAloone, Tim C.

2017-01-01

Literature provides multiple definitions on Product/Service-Systems (PSS), and as the field develops, certain trajectories emerge. The purpose ofthis article is to provide an overview of the stabilization of PSS definitions within PSS research, by presenting the most prominent PSS definitionsand...... their interrelationships. As the result of a strict protocol, the paper identifies 52 prominent definitions related to PSS, where the citationrelations between the prominent definitions are studied and graphically illustrated. The definitions are furthermore analyzed to identify commonPSS definition characteristics...... and eleven different characteristics identified. Descriptive analysis is carried out on the identified PSS definitioncharacteristics, to determine commonalties and differences in the field. Even though the literature provides many different variations of PSS definitions, there is certain convergence...

Epidemiology of multiple sclerosis in London and Middlesex County, Ontario, Canada.

Science.gov (United States)

Hader, W J; Elliot, M; Ebers, G C

1988-04-01

A case-controlled epidemiologic study of multiple sclerosis (MS) was carried out in London, Ontario, and its surrounding Middlesex County for the period 1974-1983. The prevalence rates for clinically definite/probable MS on January 1, 1984 were 94/100,000 for the city and 91/100,000 for the county. The estimated annual incidence rate for the decade 1974-83 was 3.4/100,000. The female-to-male sex ratio was 2.5:1. A familial history of MS was recorded in 14.4% of close relatives and a total of 17% when distant relatives are included. The MS group is predominantly of British (70%) and European (23%) origin. The urban-rural residence pattern analysis indicates no significant regional influence on the risk of developing MS.

European academy of dermatology and venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo.

Science.gov (United States)

Pereira, M P; Steinke, S; Zeidler, C; Forner, C; Riepe, C; Augustin, M; Bobko, S; Dalgard, F; Elberling, J; Garcovich, S; Gieler, U; Gonçalo, M; Halvorsen, J A; Leslie, T A; Metz, M; Reich, A; Şavk, E; Schneider, G; Serra-Baldrich, E; Ständer, H F; Streit, M; Wallengren, J; Weller, K; Wollenberg, A; Bruland, P; Soto-Rey, I; Storck, M; Dugas, M; Weisshaar, E; Szepietowski, J C; Legat, F J; Ständer, S

2017-08-31

The term prurigo has been used for many decades in dermatology without clear definition, and currently used terminology of prurigo is inconsistent and confusing. Especially, itch-related prurigo remains unexplored regarding the epidemiology, clinical profile, natural course, underlying causes, available treatments and economic burden, although burdensome and difficult to treat. To address these issues, the multicentre European Prurigo Project (EPP) was designed to increase knowledge on chronic prurigo (CPG). In the first step, European experts of the EADV Task Force Pruritus (TFP) aimed to achieve a consensus on the definition, classification and terminology of CPG. Additionally, procedures of the cross-sectional EPP were discussed and agreed upon. Discussions and surveys between members of the TFP served as basis for a consensus conference. Using the Delphi method, consensus was defined as an agreement ≥75% among the present members. Twenty-four members of the TFP participated in the consensus conference. Experts consented that CPG should be used as an umbrella term for the range of clinical manifestations (e.g. papular, nodular, plaque or umbilicated types). CPG is considered a distinct disease defined by the presence of chronic pruritus for ≥6 weeks, history and/or signs of repeated scratching and multiple localized/generalized pruriginous skin lesions (whitish or pink papules, nodules and/or plaques). CPG occurs due to a neuronal sensitization to itch and the development of an itch-scratch cycle. This new definition and terminology of CPG should be implemented in dermatology to harmonize communication in the clinical routine, clinical trials and scientific literature. Acute/subacute forms of prurigo are separated entities, which need to be differentiated from CPG and will be discussed in a next step. In the near future, the cross-sectional EPP will provide relevant clinical data on various aspects of CPG leading to new directions in the scientific