Parental functioning and pediatric sleep disturbance: an examination of factors associated with parenting stress in children clinically referred for evaluation of insomnia.

PubMed

Byars, Kelly C; Yeomans-Maldonado, Gloria; Noll, Jennie G

2011-10-01

Parenting stress is an aspect of parent functioning relevant in clinical settings. Within the context of behavioral sleep medicine, the role of parenting stress is not well understood. Prospective evaluation of patients 1.5-10 years old with insomnia. Subjects were 156 primary caregiver-child pairs who completed the Parenting Stress Index-Short Form (PSI-SF), Child Sleep Habits Questionnaire (CSHQ) and Child Behavior Checklist (CBCL). (1) determine prevalence of clinically significant parenting stress in primary caregivers of children clinically referred for insomnia; (2) identify childhood sleep problems that play a role in parenting stress; (3) identify relevant correlates of parenting stress within the context of a behavioral sleep medicine clinic; and (4) identify the most salient child sleep and behavioral variables associated with parenting stress. Forty-seven percent of primary caregivers had clinically significant parenting stress. When examining the relationship between child sleep problems and parenting stress, bedtime resistance (p=0.030) and daytime sleepiness (p=0.0003) stood alone as having the most salient associations with parenting stress. When considering a broader range of covariates (child age and child gender) and clinically relevant variables (parent history of sleep problems, parent history of psychiatric conditions, child behavior problems and child sleep problems) in a single regression equation, both child externalizing behavior problems (β=0.570, p<0.0001) and child daytime sleepiness (β=0.152, p=0.028) independently explained significant variability in parenting stress. Many primary caregivers of children clinically-referred for insomnia evaluation and treatment have significant parenting stress. Parenting stress is associated with daytime behavioral problems and sleepiness in children with insomnia. Clinicians working with pediatric insomnia patients should carefully evaluate parenting stress and child daytime behavior as these aspects of functioning may have an impact on service delivery and treatment outcomes. Copyright © 2011 Elsevier B.V. All rights reserved.

Contact fatigue mechanisms as a function of crystal aspect ratio in baria-silicate glass ceramics

NASA Astrophysics Data System (ADS)

Suputtamongkol, Kallaya

2003-10-01

Ceramic materials are potentially useful for dental applications because of their esthetic potential and biocompatibility. However, the existence of fatigue damage in ceramics raises considerable concern regarding its effect on the life prediction of dental prostheses. During normal mastication, dental restorations are subjected to repeated loading more than a thousand times per day and relatively high clinical failure rates for ceramic prostheses have been reported. To simulate the intraoral loads, Hertzian indentation loading was used in this study to characterize the fatigue failure mechanisms of ceramic materials using clinically relevant parameters. The baria-silicate system was chosen because of the nearly identical composition between the crystal and the glass matrix. Little or no residual stress is expected from the elastic modulus and thermal expansion mismatches between the two phases. Crystallites with different aspect ratios can also be produced by controlled heat treatment schedules. The objective of this study was to characterize the effect of crystal morphology on the fatigue mechanisms of bariasilicate glass-ceramics under clinically relevant conditions. The results show that the failure of materials with a low toughness such as baria-silicate glass (0.7 MPa•m1/2) and glass-ceramic with an aspect ratio of 3/1 (1.3 MPa•m1/2) initiated from a cone crack developed during cyclic loading for 103 to 105 cycles. The mean strength values of baria-silicate glass and glass-ceramic with an aspect ratio of 3/1 decreased significantly as a result of the presence of a cone crack. Failure of baria-silicate glass-ceramics with an aspect ratio of 8/1 (Kc = 2.1 MPa•m1/2) was initiated from surface flaws caused by either polishing or cyclic loading. The gradual decrease of fracture stress was observed in specimens with an aspect ratio of 8/1 after loading in air for 103 to 10 5 cycles. A reduction of approximately 50% in fracture stress levels was found for specimens with an aspect ratio of 8/1 after loading for 10 5 cycles in deionized water. The mechanisms for cyclic fatigue crack propagation in baria-silicate glass-ceramics are similar to those observed under quasi-static loading conditions. An intergranular fracture path was observed in glass-ceramics with an aspect ratio of 3/1. For an aspect ratio of 8/1, a transgranular fracture mode was dominant.

Treatment of endo-periodontal lesion using leukocyte-platelet-rich fibrin. A case report

PubMed Central

Elgueta, Ricardo; Fuentes, Ramon

2017-01-01

Abstract Case Description: The main objective of this paper was to report the clinical effectiveness of leukocyte- platelet- rich fibrin (L-PRF) in the treatment of a combined endo-periodontal lesion of an upper first premolar. Clinical Findings: The tooth had a profound abfraction on the vestibular aspect and presented no mobility but revealed a deep pocket measuring of 11 mm on the mesial vestibular aspect and 14 mm on the mesial palatine aspect. The three dimensional image analysis showed total bone loss in the mesial aspect and an extensively bone loss of the vestibular aspect of the vestibular root. Treatment and Outcome: Endodontic treatment was performed and periodontal access surgery (surgical periodontal therapy) was done with the application of autologous L-PRF. Three month and 6 months after surgery, the cone beam computed tomography (CBCT) exams showed no bone regeneration in any aspect of the tooth. However, periodontal examination showed a significative improvement in the deepness of surcus. The mesial vestibular aspect had a deep pocket of 3 mm and 5 mm on the mesial palatine aspect showing a reduction in deepness of 8 mm and 9 mm, respectively. Clinical Relevance: The actual treatment for teeth with bad prognosis is the extraction and replacement with implants. Even though implants are capable of restore function and aesthetic, the abuse of this approach have led to the loss of teeth that could be successfully treated with a less invasive technique. The prognosis of teeth with endoperiodontal lesion is poor but could be enhanced with regenerative therapies. Until now there are no clinical trials and just four case report about the treatment of these teeth with platelet rich fibrin. PMID:29662262

[Diagnosis and clinical management of urinary tract infection].

PubMed

Heilberg, Ita Pfeferman; Schor, Nestor

2003-01-01

A review about recent aspects on diagnosis and clinical management of urinary tract infection (UTI) is presented. There is a wide variation in clinical presentation of UTI which include different forms as cystitis, pyelonephritis, urethral syndrome and the clinical relevance of asymptomatic bacteriuria and low-count bacteriuria that must be distinguished from contamination. Pathogenetic aspects concerning bacterial virulence as well as host factors in susceptibility to UTI as urinary tract obstruction, vesicoureteral reflux, indwelling bladder catheters, pregnancy, diabetes mellitus, sexual activity, contraceptive methods, prostatism, menopause, advanced age and renal transplantation are discussed. Diagnostic criteria and the most common tests utilized for differentiation between lower and upper UTI have been reviewed. The authors conclude that a careful evaluation of the underlying factors is required for the correct diagnosis of UTI and to prevent recurrence and that appropriate strategies and specific therapeutic regimens may maximize the benefit while reducing costs and adverse reactions.

Adequate Patient Characterization in COPD: Reasons to Go Beyond GOLD Classification

PubMed Central

Verhage, Tewe L; Heijdra, Yvonne F; Molema, Johan; Daudey, Leonie; Dekhuijzen, P.N Richard; Vercoulen, Jan H

2009-01-01

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) serves as a guide to treat and manage different severity classes of patients with COPD. It was suggested that the five categories of FEV1 % predicted (GOLD 0–4), can be applied for selecting different therapeutic approaches. However, validation of these selective properties is very poor. To determine the relevance of the GOLD staging system for estimating the severity of clinical problems, GOLD 2 (n=70) and GOLD 3 (n=65) patients were drawn from a prospective cohort of patients with COPD and evaluated crosssectionally by a newly developed Nijmegen Integral Assessment Framework (NIAF). The NIAF is a detailed assessment of a wide range of aspects of health status (HS). Significant, though small, differences were found in Static Lung Volumes, Exercise Capacity, Subjective Pulmonary Complaints, Subjective Impairment, and Health-Related QoL, besides Airflow of course. Moreover, overlap between scores of these five HS sub-domains was substantial, indicating small clinical relevance for discernment. No significant differences were found in nine other aspects of HS. It is concluded that GOLD stages do not discriminate in any aspect of HS other than airflow obstruction, and therefore do not help the clinician in deciding which treatment modalities are appropriate. PMID:19452033

Blood lactate concentration after exposure to conducted energy weapons (including TASER® devices): is it clinically relevant?

PubMed

Jauchem, James R

2013-09-01

In previous studies, blood lactate concentration (BLac) consistently increased in anesthetized animals and in human subjects after exposures to TASER(®) conducted energy weapons (CEWs). Some have suggested the increased BLac would have detrimental consequences. In the current review, the following are evaluated: (a) the nature of muscle contractions due to CEWs, (b) general aspects of increased BLac, (c) previous studies of conventional neuromuscular electrical stimulation and CEW exposures, and (d) BLac in disease states. On the basis of these analyses, one can conclude that BLac, per se (independent of acidemia), would not be clinically relevant immediately after short-duration CEW applications, due to the short time course of any increase.

A practical guide to diagnostic transcranial magnetic stimulation: Report of an IFCN committee

PubMed Central

Groppa, S.; Oliviero, A.; Eisen, A.; Quartarone, A.; Cohen, L.G.; Mall, V.; Kaelin-Lang, A.; Mima, T.; Rossi, S.; Thickbroom, G.W.; Rossini, P.M.; Ziemann, U.; Valls-Solé, J.; Siebner, H.R.

2016-01-01

Transcranial magnetic stimulation (TMS) is an established neurophysiological tool to examine the integrity of the fast-conducting corticomotor pathways in a wide range of diseases associated with motor dysfunction. This includes but is not limited to patients with multiple sclerosis, amyotrophic lateral sclerosis, stroke, movement disorders, disorders affecting the spinal cord, facial and other cranial nerves. These guidelines cover practical aspects of TMS in a clinical setting. We first discuss the technical and physiological aspects of TMS that are relevant for the diagnostic use of TMS. We then lay out the general principles that apply to a standardized clinical examination of the fast-conducting corticomotor pathways with single-pulse TMS. This is followed by a detailed description of how to examine corticomotor conduction to the hand, leg, trunk and facial muscles in patients. Additional sections cover safety issues, the triple stimulation technique, and neuropediatric aspects of TMS. PMID:22349304

Genesis of Preeclampsia: An Epidemiological Approach

PubMed Central

Salvador-Moysén, Jaime; Martínez-López, Yolanda; Ramírez-Aranda, José M.; Aguilar-Durán, Marisela; Terrones-González, Alberto

2012-01-01

There are analyzed some of the main aspects related to the causality of preeclampsia, privileging two types of models: the clinic model and the epidemiologic model, first one represented by the hypothesis of the reduced placental perfusion and the second one considering the epidemiologic findings related to the high levels of psychosocial stress and its association with preeclampsia. It is reasoned out the relevance of raising the causality of the disease from an interdisciplinary perspective, integrating the valuable information generated from both types, clinical and epidemiologic, and finally a tentative explanatory model of preeclampsia is proposed, the subclinical and sociocultural aspects that predispose and trigger the disease are emphasized making aspects to stand out: the importance of reduced placental perfusion as an indicator of individual risk, and the high levels of physiological stress, as a result of the unfavorable conditions of the psychosocial surroundings (indicator of population risk) of the pregnant women. PMID:22462008

A review of breast tomosynthesis. Part II. Image reconstruction, processing and analysis, and advanced applications

PubMed Central

Sechopoulos, Ioannis

2013-01-01

Many important post-acquisition aspects of breast tomosynthesis imaging can impact its clinical performance. Chief among them is the reconstruction algorithm that generates the representation of the three-dimensional breast volume from the acquired projections. But even after reconstruction, additional processes, such as artifact reduction algorithms, computer aided detection and diagnosis, among others, can also impact the performance of breast tomosynthesis in the clinical realm. In this two part paper, a review of breast tomosynthesis research is performed, with an emphasis on its medical physics aspects. In the companion paper, the first part of this review, the research performed relevant to the image acquisition process is examined. This second part will review the research on the post-acquisition aspects, including reconstruction, image processing, and analysis, as well as the advanced applications being investigated for breast tomosynthesis. PMID:23298127

Prevention of Child Maltreatment: The Use of Social Support Systems.

ERIC Educational Resources Information Center

Anderson, Dale Robert

A review of the clinically relevant literature on prevention of child maltreatment was conducted in an attempt to provide: (1) a definition and theoretical understanding of some aspects of prevention, child maltreatment, and social support systems; (2) a proposal of the usefulness of social isolation as an important theme in interpreting the…

Assessment of Competence in Clinical Reasoning and Decision-Making under Uncertainty: The Script Concordance Test Method

ERIC Educational Resources Information Center

Ramaekers, Stephan; Kremer, Wim; Pilot, Albert; van Beukelen, Peter; van Keulen, Hanno

2010-01-01

Real-life, complex problems often require that decisions are made despite limited information or insufficient time to explore all relevant aspects. Incorporating authentic uncertainties into an assessment, however, poses problems in establishing results and analysing their methodological qualities. This study aims at developing a test on clinical…

[Autoantibody-associated autoimmune encephalitis and cerebellitis : Clinical presentation, diagnostic work-up and treatment].

PubMed

Lewerenz, J; Jarius, S; Wildemann, B; Wandinger, K-P; Leypoldt, F

2016-12-01

There is no other field of neurology where clinically relevant serological biomarkers have witnessed a surge in importance over the past decade resembling that in autoimmune encephalitis and cerebellitis. A multitude of newly discovered neuronal autoantibodies facilitate early diagnosis, estimation of prognosis, and therapeutic decision-making. However, this has led to growing uncertainty with regard to meaningful patient selection, the appropriate extent of testing, and management of seronegative cases. This review summarizes the essential aspects of the clinical presentation, diagnostic work-up, pathophysiology, and treatment of autoimmune encephalitis and cerebellitis.

Current status of matrix-assisted laser desorption ionisation-time of flight mass spectrometry in the clinical microbiology laboratory.

PubMed

Kok, Jen; Chen, Sharon C A; Dwyer, Dominic E; Iredell, Jonathan R

2013-01-01

The integration of matrix-assisted laser desorption ionisation-time of flight mass spectrometry (MALDI-TOF MS) into many clinical microbiology laboratories has revolutionised routine pathogen identification. MALDI-TOF MS complements and has good potential to replace existing phenotypic identification methods. Results are available in a more clinically relevant timeframe, particularly in bacteraemic septic shock. Novel applications include strain typing and the detection of antimicrobial resistance, but these are not widely used. This review discusses the technical aspects, current applications, and limitations of MALDI-TOF MS.

The PEACE project review of clinical instruments for hospice and palliative care.

PubMed

Hanson, Laura C; Scheunemann, Leslie P; Zimmerman, Sheryl; Rokoske, Franziska S; Schenck, Anna P

2010-10-01

Hospice and palliative care organizations are expanding their use of standardized instruments and other approaches to measure quality. We undertook a systematic review and evaluation of published patient-level instruments for potential application in hospice and palliative care clinical quality measurement. We searched prior reviews and computerized reference databases from 1990 through February 2007 for studies of instruments relevant to physical, psychological, social, cultural, spiritual, or ethical aspects of palliative care, or measuring prognosis, function or continuity of care. Publications were selected for full review if they provided evidence of psychometric properties or practical application of an instrument tested in or appropriate for a hospice or palliative care population. Selected instruments were evaluated and scored for scientific soundness and potential application in clinical quality measurement. The search found 1427 publications, with 229 selected for full manuscript review. Manuscripts provided information on 129 instruments which were evaluated using a structured scoring guide for psychometric properties. Thirty-nine instruments scoring near or above the 75th percentile were recommended. Most instruments covered multiple domains or focused on care for physical symptoms, psychological or social aspects of care. Few instruments were available to measure cultural aspects of care, structure and process of care, and continuity of care. Numerous patient-level instruments are available to measure physical, psychological and social aspects of palliative care with adequate evidence for scientific soundness and practical clinical use for quality improvement and research. Other aspects of palliative care may benefit from further instrument development research.

Rey Figure Test with recognition trial: normative data for Lebanese adults.

PubMed

Darwish, Hala; Zeinoun, Pia; Farran, Natali; Fares, Souha

2018-06-12

This study aimed to provide normative data for four trials of the Rey figure Test - a complex design used to assess visuoconstructional abilities, aspects of visual memory, and aspects of executive functioning. Despite its frequent clinical and research use in the Arab region, published studies regarding the measures' adaptation or normative data remain absent. We administered the Rey figure on a convenience sample of Lebanese (n = 254) aged 30 years to 99. We examined the impact of relevant demographics, and found that age, gender, and years of education impacted scores, and norms were derived based on these variables. Such normative data for the Rey figure enhance its practicality and psychometric adequacy for use in research and clinical settings in Lebanon.

[Laparoscopic aspect and clinical relevance of cholangiofibromas].

PubMed

Henning, H; Friedrich, K; Lüders, C J

1982-12-01

In a current series of 1160 laparoscopies in 38 cases (3.2%) we found cholangiofibromas. The picture of single, sporadic and multiple cholangiofibromas as well as cholangiofibromatosis is both described and documented by laparoscopic photography. Clinically it seems remarkable that only patients with alcohol- or drug-induced liver injury showed such alterations. The prevalence of cholangiofibromas in toxic liver damage suggests that we are here not dealing with embryonal aberrations (hamartomas) but apparently with cellular inductive phenomena.

[Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

PubMed

Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

2011-10-01

As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

Theory of mind, social development, and psychosis.

PubMed

Casacchia, Massimo; Mazza, Monica; Roncone, Rita

2004-06-01

The difficulty in interpreting other people's mental states found in children with autism and in people affected by schizophrenia may be explained in terms of a unique mental process called Theory of Mind. The paper discusses the main operational issues of such a peculiar aspect of social cognition, the Theory of Mind, and its implication in schizophrenia, including a review of its related neural structures. Theory of Mind abilities may be a relevant aspect of social interaction involving people affected by schizophrenia, and they need to be further investigated in clinical research.

Methodology for research I.

PubMed

Garg, Rakesh

2016-09-01

The conduct of research requires a systematic approach involving diligent planning and its execution as planned. It comprises various essential predefined components such as aims, population, conduct/technique, outcome and statistical considerations. These need to be objective, reliable and in a repeatable format. Hence, the understanding of the basic aspects of methodology is essential for any researcher. This is a narrative review and focuses on various aspects of the methodology for conduct of a clinical research. The relevant keywords were used for literature search from various databases and from bibliographies of the articles.

Intra- and Extra-cellular Proteome Analyses of Steroid-Producer Mycobacteria.

PubMed

Barreiro, Carlos; Morales, Alejandro; Vázquez-Iglesias, Inés; Sola-Landa, Alberto

2017-01-01

The importance of the pathogenic mycobacteria has mainly focused the omic analyses on different aspects of their clinical significance. In contrast, those industrially relevant mycobacteria have received less attention, even though the steroids market sales in 2011, in example, were estimated in $8 billion.The extra-cellular proteome, due to its relevance in the sterols processing and uptake; as well as the intra-cellular proteome, because of its role in steroids bioconversion, are the core of the present chapter. As a proof of concept, the obtaining methods for both sub-proteomes of Mycobacterium neoaurum NRRL B-3805, a relevant industrial strain involved in steroids production, have been developed. Thus, procedures and relevant key points of these proteomes analyses are fully described.

Teaching the clinical encounter in psychiatry: a trial of Balint groups for medical students.

PubMed

Parker, Stephen; Leggett, Andrew

2012-08-01

Balint groups are being trialled as a method to facilitate understanding of the relational aspects of student encounters with psychiatric patients. This paper reports on the establishment, processes and trends in the student evaluations of these groups. The groups have been introduced as part of the medical student curriculum at a tertiary referral hospital. In six of the eight weeks of the clinical rotation in psychiatry, students meet in a group led by the authors, to discuss relational aspects of their interactions with patients. Ten third-year postgraduate medical students participate in the group each rotation. The educational value of each meeting and the group overall is assessed using questionnaires. The groups tended to be rated positively by the participants. However, students were less certain of the relevance to their clinical practice. Vignettes demonstrating aspects of group process are presented in the context of the leaders' experiential account. Short-term clinical reflection groups can be effectively implemented for medical students in a hospital environment. These groups have the potential to support students in the process of learning to work in doctor-patient relationships, but may encounter significant challenges necessitating adaptation of method and process to context.

Synthetic Cannabinoids: Psychopharmacology, Clinical Aspects, Psychotic Onset.

PubMed

Martinotti, Giovanni; Santacroce, Rita; Papanti, Duccio; Elgharably, Yasmine; Prilutskaya, Mariya; Corazza, Ornella

2017-01-01

Synthetic Cannabinoids (SC) are the widest and most diffused class of Novel Psychoactive Substances. The short- and long- term health risks associated with the consumption of SC are often unknown to both users and health professionals. This review aims to provide a synthesis of the most recent and relevant insights on the pharmacology, clinical and psychopathological aspects of SC. A structured search of two bibliographic databases (PubMed and Scopus) was undertaken according to inclusion/exclusion criteria. The following terms "synthetic cannabinoid*", "synthetic cannabimimetic*", "synthetic cannabis", "synthetic marijuana" and "Spice AND cannabinoid*" were used as search strings. 162 relevant results, mainly published in the past two years were revealed. Most results emerged for the keyword "synthetic cannabinoid*", followed by the combination "Spice* AND "cannabinoid*". Most papers were epidemiological, forensic, toxicologic, or analytical. The results of studies were systematized according their contribution to the comprehension of pharmacological, clinical and psychopathological effects of SC. Fifteen SC-related fatality cases were reviewed according to their histories, pathology and toxicology findings. The findings of this review confirm the importance of prompt and reliable information available for health professionals More specific analytic techniques and designed preventive strategies are required to face unprecedented SC challenge. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The white book of radiation oncology in Spain.

PubMed

Herruzo, Ismael; Romero, Jesús; Palacios, Amalia; Mañas, Ana; Samper, Pilar; Bayo, Eloísa; Guedea, Ferran

2011-06-01

The White Book of Radiation Oncology provides a comprehensive overview of the current state of the speciality of radiation oncology in Spain and is intended to be used as a reference for physicians, health care administrators and hospital managers. The present paper summarises the most relevant aspects of the book's 13 chapters in order to bring the message to a wider audience. Among the topics discussed are the epidemiology of cancer in Spain, the role of the radiation oncologist in cancer care, human and material resource needs, new technologies, training of specialists, clinical and cost management, clinical practice, quality control, radiological protection, ethics, relevant legislation, research & development, the history of radiation oncology in Spain and the origins of the Spanish Society of Radiation Oncology (SEOR).

[Organization of clinical research: in general and visceral surgery].

PubMed

Schneider, M; Werner, J; Weitz, J; Büchler, M W

2010-04-01

The structural organization of research facilities within a surgical university center should aim at strengthening the department's research output and likewise provide opportunities for the scientific education of academic surgeons. We suggest a model in which several independent research groups within a surgical department engage in research projects covering various aspects of surgically relevant basic, translational or clinical research. In order to enhance the translational aspects of surgical research, a permanent link needs to be established between the department's scientific research projects and its chief interests in clinical patient care. Importantly, a focus needs to be placed on obtaining evidence-based data to judge the efficacy of novel diagnostic and treatment concepts. Integration of modern technologies from the fields of physics, computer science and molecular medicine into surgical research necessitates cooperation with external research facilities, which can be strengthened by coordinated support programs offered by research funding institutions.

A new quality of bone ultrasound research.

PubMed

Gluer, C C

2008-07-01

Quantitative ultrasound (QUS) methods have strong power to predict osteoporotic fractures, but they are also very relevant for the assessment of bone quality. A representative sample of recent studies addressing these topics can be found in this special issue. Further pursuit of these methods will establish micro-QUS imaging methods as tools for measuring specific aspects of bone quality. Once this is achieved, we will be able to link such data to the clinical QUS methods used in vivo to determine which aspects of bone quality cause QUS to be a predictor of fracture risk that is independent of bone mineral density (BMD). Potentially this could lead to the development of a new generation of QUS devices for improved and expanded clinical assessment. Good quality of basic science work will thus lead to good quality of clinical patient examinations on the basis of a more detailed assessment of bone quality.

Importance of nutritional support in older people.

PubMed

Sánchez García, E; Montero Errasquín, B; Sánchez Castellano, C; Cruz-Jentoft, A J

2012-01-01

Proper nutrition is an essential part of successful aging and may delay the onset of diseases. Nutrition-related problems in older subjects have been long-time ignored; good nutritional status is an essential component of health and a relevant part of therapeutic plans of most chronic diseases. Moreover, food and nutrition are a relevant aspect of most cultures and are strongly linked with individual lifestyles. Research has proved that nutritional intervention can improve outcomes in many clinical scenarios. This is especially true for older individuals with different acute and chronic conditions and diseases, or with malnutrition. Nutritional intervention can provide sufficient energy, protein and micronutrients, maintain or improve nutritional status, reduce morbidity and increase survival. Evidence is still lacking on the impact of nutritional intervention on physical and mental function, and on quality of life, very relevant outcomes for older individuals. Nutritional screening and assessment should become part of health care of both healthy and sick older people. Nutritional counseling and intervention should be embedded in a general care plan that takes into account all aspects of an aging person. Nutritional programs that aim for high compliance should be individualized, and would have to consider every aspect of old age: beliefs, attitudes, preferences, expectations, and aspirations. Copyright © 2012 S. Karger AG, Basel.

Factors Related to Self-Rated Participation in Adolescents and Adults with Mild Intellectual Disability--A Systematic Literature Review

ERIC Educational Resources Information Center

Arvidsson, Patrik; Granlund, Mats; Thyberg, Mikael

2008-01-01

Background: Self-rated participation is a clinically relevant intervention outcome for people with mild intellectual disability. The aim of this systematic review was to analyse empirical studies that explored relationships between either environmental factors or individual characteristics "and" aspects of participation in young adults with mild…

Clinical forensic aspects of self-inflicted neck injuries.

PubMed

Govi, Annamaria; Fersini, Federica; Etzold, Saskia; Tsokos, Michael

2018-06-01

The distinction between self-inflicted injuries and other types of injuries is crucial in forensic medicine, and relevant features of wounds should be identified by pathologists, even when they are observed at atypical sites. Herein we report two cases of self-inflicted injuries of the neck involving two young women who had reported being attacked by men.

Important aspects of participation and participation restrictions in people with a mild intellectual disability.

PubMed

Arvidsson, Patrik; Granlund, Mats; Thyberg, Ingrid; Thyberg, Mikael

2014-01-01

This study explored a possibility to assess the concepts of participation and participation restrictions in the International Classification of Functioning, Disability and Health (ICF) by combining self-ratings of the perceived importance with the actual performance of different everyday activities in people with a mild intellectual disability. Structured interviews regarding 68 items from the ICF activity/participation domain were conducted (n = 69). The items were ranked by perceived importance, performance and by combined measures. Furthermore, the measures were related to a single question about subjective general well-being. Rankings of performance highlighted about the same items as "important participation", while rankings of low performance addressed quite different items compared with "important participation restriction". Significant correlations were found between subjective general well-being and high performance (r = 0.56), high performance/high importance (important participation) (r = 0.56), low performance (r = -0.56) and low performance/high importance (important participation restriction; r = -0.55). The results support the clinical relevance of the ICF and the studied selection of 68 items. Although performance only may sometimes be a relevant aspect, knowledge about the relationship between the perceived importance and the actual performance is essential for clinical interventions and for research aiming to understand specific needs regarding participation. The concepts of participation and participation restriction are highly relevant in people with a mild intellectual disability. Self-rated performance might be sufficient to assess participation at a group level. In clinical practices, the relationship between the perceived importance and the actual performance of an activity is essential to assess.

Advances in the understanding of the clinically relevant genetic pathways and molecular aspects of canine mammary tumours. Part 2: invasion, angiogenesis, metastasis and therapy.

PubMed

Santos, A A; Matos, A J F

2015-08-01

Significant advances have been made recently in the understanding of the molecular events and critical pathways associated with and driving cancer of the mammary gland in humans and dogs. The study of canine mammary tumour biology, particularly the interactions of neoplastic cells with stromal and immune cells, is crucial for the development of novel effective therapeutic agents and strategies. This second part of a two-part review discusses some of the latest advances in the understanding of the clinically relevant genetic and molecular pathways involved in metastasis and in the interactions between tumour and stromal cells, including inflammatory and immune cells, cancer-associated fibroblasts, and endothelial cells. Recent experimental data on the role of matrix-degrading proteases and angiogenic factors are also discussed. Finally, the clinical utility of different non-surgical therapeutic modalities is reviewed. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Assessment of SUSARs. Clinical evaluation of single cases in terms of regulatory requirements].

PubMed

Wroblewski, H; Schmickler, M

2005-04-01

In the course of implementing the European directives on pharmaceutical law, focus is set on suspected unexpected serious adverse reactions (SUSARs). SUSARs are essential for expedited reporting to authorities and ethics committees. During on-line monitoring of the study, the investigator documents all adverse events. Serious adverse events are forwarded to the sponsor in due time. The sponsor identifies SUSARs for expedited reporting. Clinical causality assessment between the investigational product and the adverse event is substantial in this process. This requires a balanced clinical assessment of all case relevant aspects and information available reflecting the complexity of the specific case, which cannot be covered by algorithms in general. In the setting of on-line monitoring, SUSARs ensure the safety of the patient and the study. In addition, SUSARs are relevant for generation of the safety profile of the substance.

Critical issues in clinical periodontal research.

PubMed

Preshaw, Philip M

2012-06-01

As periodontal researchers and clinicians, we are challenged every day to make decisions relating to the clinical management of our patients and about how best to conduct clinical periodontal research. This volume of Periodontology 2000 addresses some of the critical issues in contemporary clinical periodontics and periodontal research that are of direct relevance to clinicians, researchers, teachers and students. The 11 review articles in this volume of Periodontology 2000 focus on aspects of periodontal research methodology and clinical periodontology. In terms of research methodology, the articles aim to inform the reader on topics relating to randomized controlled trials in periodontal research, evidence-based dentistry, calibration of clinical examiners and statistics relevant to periodontal research. The clinical periodontology articles address issues relating to decisions on retaining periodontally compromised teeth or replacing them with implants, periodontal management in the patient with osteoporosis, surgical approaches for root coverage and the emerging science of advanced regenerative technologies, including the use of stem cells, for periodontal regeneration. It is hoped that these critical reviews will address many of the dilemmas that confront us on a regular basis and provide practical guidance to those engaged in both clinical periodontology and clinical periodontal research. © 2012 John Wiley & Sons A/S.

Dental Cements for Luting and Bonding Restorations: Self-Adhesive Resin Cements.

PubMed

Manso, Adriana P; Carvalho, Ricardo M

2017-10-01

Self-adhesive resin cements combine easy application of conventional luting materials with improved mechanical properties and bonding capability of resin cements. The presence of functional acidic monomers, dual cure setting mechanism, and fillers capable of neutralizing the initial low pH of the cement are essential elements of the material and should be understood when selecting the ideal luting material for each clinical situation. This article addresses the most relevant aspects of self-adhesive resin cements and their potential impact on clinical performance. Although few clinical studies are available to establish solid clinical evidence, the information presented provides clinical guidance in the dynamic environment of material development. Copyright © 2017 Elsevier Inc. All rights reserved.

[About the Cotard's syndrome].

PubMed

Nagy, Agnes; Vörös, Viktor; Tényi, Tamás

2008-10-01

INTRODUCTION, AIMS: The authors present the Cotard's syndrome, a rare psychiatric condition, pointing out the latest results in terms of etiology and psychoneurology. The central feature of the syndrome is a nihilistic delusion, in which the patient denies his or her own existence and that of the external world. We searched electronic databases using the appropriate search terms, relevant articles were carefully reviewed. We present three cases from our clinical practice. After the overview of the latest biological and neuropsychological findings, the historical aspects of the condition, the terminology, the nosology, the classification, the differential diagnostics and the etiology are discussed. The psychopathology and the phenomenology of Cotard's syndrome are also presented, shedding light on existential aspects as well. To sum up with useful information for the clinical practice, the possible treatment strategies, the course and the prognosis of the disease are also discussed. The presented theoretical and practical aspects give a lead on deeper understanding, easier recognition and more adequate therapy of the Cotard's syndrome.

[Economic aspects of oncological esophageal surgery : Centralization is essential].

PubMed

von Dercks, N; Gockel, I; Mehdorn, M; Lorenz, D

2017-01-01

The incidence of esophageal carcinoma has increased in recent years in Germany. The aim of this article is a discussion of the economic aspects of oncological esophageal surgery within the German diagnosis-related groups (DRG) system focusing on the association between minimum caseload requirements and outcome quality as well as costs. The margins for the DRG classification G03A are low and quickly exhausted if complications determine the postoperative course. A current study using nationwide German hospital discharge data proved a significant difference in hospital mortality between clinics with and without achieving the minimum caseload requirements for esophagectomy. Data from the USA clearly showed that besides patient-relevant parameters, the caseload of a surgeon is relevant for the cost of treatment. Such cost-related analyses do not exist in Germany at present. Scientific validation of reliable minimum caseload numbers for oncological esophagectomy is desirable in the future.

Balneotherapy in rheumatic diseases--an overview of novel and known aspects.

PubMed

Lange, U; Müller-Ladner, U; Schmidt, K L

2006-04-01

Balneotherapeutic applications to treat rheumatic diseases have a long-term tradition and are based on established scientific principles, and the majority of rheumatic diseases most frequently include balneotherapy. However, as other therapeutic strategies, balneological interventions require scientific proof of their effect and efficacy. Notably, recent studies providing evidence of the thermic and chemical effects on the immune system and cytokine milieu have enforced the revival of the traditional balneological interventions. This review provides an overview of the known as well as the novel aspects of balneotherapy and their clinical relevance in the treatment of rheumatic diseases.

Clinical microbiology informatics.

PubMed

Rhoads, Daniel D; Sintchenko, Vitali; Rauch, Carol A; Pantanowitz, Liron

2014-10-01

The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Clinical Microbiology Informatics

PubMed Central

Sintchenko, Vitali; Rauch, Carol A.; Pantanowitz, Liron

2014-01-01

SUMMARY The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. PMID:25278581

Residents' views of the role of classroom-based learning in graduate medical education through the lens of academic half days.

PubMed

Chen, Luke Y C; McDonald, Julie A; Pratt, Daniel D; Wisener, Katherine M; Jarvis-Selinger, Sandra

2015-04-01

To examine the role of classroom-based learning in graduate medical education through the lens of academic half days (AHDs) by exploring residents' perceptions of AHDs' purpose and relevance and the effectiveness of teaching and learning in AHDs. The authors invited a total of 186 residents in three programs (internal medicine, orthopedic surgery, and hematology) at the University of British Columbia Faculty of Medicine to participate in semistructured focus groups from October 2010 to February 2011. Verbatim transcripts of the interviews underwent inductive analysis. Twenty-seven residents across the three programs volunteered to participate. Two major findings emerged. Purpose and relevance of AHDs: Residents believed that AHDs are primarily for knowledge acquisition and should complement clinical learning. Classroom learning facilitated consolidation of clinical experiences with expert clinical reasoning. Social aspects of AHDs were highly valued as an important secondary purpose. Perceived effectiveness of teaching and learning: Case-based teaching engaged residents in critical thinking; active learning was valued. Knowledge retention was considered suboptimal. Perspectives on the concept of AHDs as "protected time" varied in the three programs. Findings suggest that (1) engagement in classroom learning occurs through participation in clinically oriented discussions that highlight expert reasoning processes; (2) formal classroom teaching, which focuses on knowledge acquisition, can enhance informal learning occurring during clinical activity; and (3) social aspects of AHDs, including their role in creating communities of practice in residency programs and in professional identity formation, are an important, underappreciated asset for residency programs.

Molecular and functional aspects of menstruation in the macaque.

PubMed

Brenner, Robert M; Slayden, Ov D

2012-12-01

Much of our understanding of the molecular control of menstruation arises from laboratory models that experimentally recapitulate some, but not all, aspects of uterine bleeding observed in women. These models include: in vitro culture of endometrial explants or isolated endometrial cells, transplantation of human endometrial tissue into immunodeficient mice and the induction of endometrial breakdown in appropriately pretreated mice. Each of these models has contributed to our understanding of molecular and cellular mechanisms of menstruation, but nonhuman primates, especially macaques, are the animal model of choice for evaluating therapies for menstrual disorders. In this chapter we review some basic aspects of menstruation, with special emphasis on the macaque model and its relevance to the clinical issues of irregular and heavy menstrual bleeding (HMB).

Atrioventricular and intraventricular block after transcatheter aortic valve implantation.

PubMed

Lee, Jane J; Goldschlager, Nora; Mahadevan, Vaikom S

2018-06-24

Aortic stenosis is the most common valvular heart disease in industrialized countries and the most common cause of left ventricular outflow tract (LVOT) obstruction. Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for intermediate to high-risk surgical candidates with symptomatic severe aortic stenosis. Conduction system abnormalities, including atrioventricular (AV) and intraventricular (IV) block, are the most common complication of TAVR. In this review, we aim to explore the anatomical issues relevant to atrioventricular block, the relevant clinical and procedural aspects, and the management and long-term implications of AV and IV block.

Targeting innate immunity for neurodegenerative disorders of the central nervous system.

PubMed

Andreasson, Katrin I; Bachstetter, Adam D; Colonna, Marco; Ginhoux, Florent; Holmes, Clive; Lamb, Bruce; Landreth, Gary; Lee, Daniel C; Low, Donovan; Lynch, Marina A; Monsonego, Alon; O'Banion, M Kerry; Pekny, Milos; Puschmann, Till; Russek-Blum, Niva; Sandusky, Leslie A; Selenica, Maj-Linda B; Takata, Kazuyuki; Teeling, Jessica; Town, Terrence; Van Eldik, Linda J

2016-09-01

Neuroinflammation is critically involved in numerous neurodegenerative diseases, and key signaling steps of innate immune activation hence represent promising therapeutic targets. This mini review series originated from the 4th Venusberg Meeting on Neuroinflammation held in Bonn, Germany, 7-9th May 2015, presenting updates on innate immunity in acute brain injury and chronic neurodegenerative disorders, such as traumatic brain injury and Alzheimer disease, on the role of astrocytes and microglia, as well as technical developments that may help elucidate neuroinflammatory mechanisms and establish clinical relevance. In this meeting report, a brief overview of physiological and pathological microglia morphology is followed by a synopsis on PGE2 receptors, insights into the role of arginine metabolism and further relevant aspects of neuroinflammation in various clinical settings, and concluded by a presentation of technical challenges and solutions when working with microglia and astrocyte cultures. Microglial ontogeny and induced pluripotent stem cell-derived microglia, advances of TREM2 signaling, and the cytokine paradox in Alzheimer's disease are further contributions to this article. Neuroinflammation is critically involved in numerous neurodegenerative diseases, and key signaling steps of innate immune activation hence represent promising therapeutic targets. This mini review series originated from the 4th Venusberg Meeting on Neuroinflammation held in Bonn, Germany, 7-9th May 2015, presenting updates on innate immunity in acute brain injury and chronic neurodegenerative disorders, such as traumatic brain injury and Alzheimer's disease, on the role of astrocytes and microglia, as well as technical developments that may help elucidate neuroinflammatory mechanisms and establish clinical relevance. In this meeting report, a brief overview on physiological and pathological microglia morphology is followed by a synopsis on PGE2 receptors, insights into the role of arginine metabolism and further relevant aspects of neuroinflammation in various clinical settings, and concluded by a presentation of technical challenges and solutions when working with microglia cultures. Microglial ontogeny and induced pluripotent stem cell-derived microglia, advances of TREM2 signaling, and the cytokine paradox in Alzheimer's disease are further contributions to this article. © 2016 International Society for Neurochemistry.

Sporotrichosis between 1898 and 2017: The evolution of knowledge on a changeable disease and on emerging etiological agents.

PubMed

Lopes-Bezerra, Leila M; Mora-Montes, Hector M; Zhang, Yu; Nino-Vega, Gustavo; Rodrigues, Anderson Messias; de Camargo, Zoilo Pires; de Hoog, Sybren

2018-04-01

The description of cryptic species with different pathogenic potentials has changed the perspectives on sporotrichosis. Sporothrix schenckii causes a benign chronic subcutaneous mycosis, Sporothrix brasiliensis is highly virulent, and Sporothrix globosa mainly causes fixed cutaneous lesions. Furthermore, S. brasiliensis is the prevalent species related to cat-transmitted sporotrichosis. Sources of infection, transmission, and distribution patterns also differ between species, and variability differs between species because of different degrees of clonality. The present review article will cover several aspects of the biology of clinically relevant agents of sporotrichosis, including epidemiological aspects of emerging species. Genomic information of Sporothrix spp. is also discussed. The cell wall is an essential structure for cell viability, interaction with the environment, and the host immune cells and contains several macromolecules involved in virulence. Due to its importance, aspects of glycosylation and cell wall polysaccharides are reviewed. Recent genome data and bioinformatics analyses helped to identify specific enzymes of the biosynthetic glycosylation routes, with no homologs in mammalian cells, which can be putative targets for development of antifungal drugs. A diversity of molecular techniques is available for the recognition of the clinically relevant species of Sporothrix. Furthermore, antigens identified as diagnostic markers and putative vaccine candidates are described. Cell-mediated immunity plays a key role in controlling infection, but Sporothrix species differ in their interaction with the host. The adaptive branch of the immune response is essential for appropriate control of infection.

Academic espionage: dysfunctional aspects of the publish or perish ethic.

PubMed

Mensah, L L

1982-11-01

There are many dysfunctional manifestations relative to the tenure and promotion process. These are disruptive to academic life. Much of this is encouraged by the university because of their publish or perish ethic. Excellence in classroom teaching and success in the field of clinical and human endeavours are not highly valued in deliberations to grant tenure and advancement in academic rank. Research and publications are the major yardsticks upon which a faculty member is judged. This prevailing perspective poses a dilemma for many nursing faculty who have high clinical workloads and have not been socialized for academic survival. The pressures to publish and research can be achieved in a realistic and non-stressful way. Three aspects seem to be particularly relevant to facilitate this achievement; these are: anticipatory planning, balancing the workload, and understanding the interpersonal dimensions of collegiality.

Facts about an implantable contraceptive: Memorandum from a WHO Meeting*

PubMed Central

1985-01-01

This Memorandum reviews the results of research undertaken in animals and human subjects on the implantable contraceptive, Norplant, and where relevant, its components, levonorgestrel and Silastic. Results from clinical trials, including effectiveness and side-effects, are evaluated and service delivery aspects commented on. The Memorandum concludes with a statement regarding the use of Norplant as an option for long-term reversible contraception. PMID:3930082

Basics of Compounding: Clinical Pharmaceutics, Part 1.

PubMed

Allen, Loyd V

2016-01-01

Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Pharmacy is unique as it contains a knowledge base significantly different from that of physicians, nurses, and other health-related practitioners. The separation of the science and the practice of pharmacy have prevented the complete utilization of pharmaceutical sciences in the clinical environment far too long. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Portal vein thrombosis in patients with cirrhosis

PubMed Central

von Köckritz, Leona; De Gottardi, Andrea; Praktiknjo, Michael

2017-01-01

Abstract Portal vein thrombosis (PVT) is frequent in patients with liver cirrhosis and possible severe complications such as mesenteric ischemia are rare, but can be life-threatening. However, different aspects of clinical relevance, diagnosis and management of PVT are still areas of uncertainty and investigation in international guidelines. In this article, we elaborate on PVT classification, geographical differences in clinical presentation and standards of diagnosis, and briefly on the current pathophysiological understanding and risk factors. This review considers and highlights the pitfalls of the various treatment approaches and prophylactic treatments. Finally, we review the controversial issue of clinical impact of PVT on prognosis, especially considering liver transplantation and future perspectives. PMID:28533912

Precision medicine in pediatric oncology: Lessons learned and next steps.

PubMed

Mody, Rajen J; Prensner, John R; Everett, Jessica; Parsons, D Williams; Chinnaiyan, Arul M

2017-03-01

The maturation of genomic technologies has enabled new discoveries in disease pathogenesis as well as new approaches to patient care. In pediatric oncology, patients may now receive individualized genomic analysis to identify molecular aberrations of relevance for diagnosis and/or treatment. In this context, several recent clinical studies have begun to explore the feasibility and utility of genomics-driven precision medicine. Here, we review the major developments in this field, discuss current limitations, and explore aspects of the clinical implementation of precision medicine, which lack consensus. Lastly, we discuss ongoing scientific efforts in this arena, which may yield future clinical applications. © 2016 Wiley Periodicals, Inc.

Precision medicine in pediatric oncology: Lessons learned and next steps

PubMed Central

Mody, Rajen J.; Prensner, John R.; Everett, Jessica; Parsons, D. Williams; Chinnaiyan, Arul M.

2017-01-01

The maturation of genomic technologies has enabled new discoveries in disease pathogenesis as well as new approaches to patient care. In pediatric oncology, patients may now receive individualized genomic analysis to identify molecular aberrations of relevance for diagnosis and/or treatment. In this context, several recent clinical studies have begun to explore the feasibility and utility of genomics-driven precision medicine. Here, we review the major developments in this field, discuss current limitations, and explore aspects of the clinical implementation of precision medicine, which lack consensus. Lastly, we discuss ongoing scientific efforts in this arena, which may yield future clinical applications. PMID:27748023

Treatment of osteoporosis in men

PubMed Central

Kaufman, J.-M.; Reginster, J.-Y.; Boonen, S.; Brandi, M. L.; Cooper, C.; Dere, W.; Devogelaer, J.-P.; Diez-Perez, A.; Kanis, J. A.; McCloskey, E.; Mitlak, B.; Orwoll, E.; Ringe, J.D.; Weryha, G.; Rizzoli, R.

2013-01-01

Summary Aspects of osteoporosis in men, such as screening and identification strategies, definitions of diagnosis and intervention thresholds, and treatment options (both approved and in the pipeline) are discussed. Introduction Awareness of osteoporosis in men is improving, although it remains under-diagnosed and under-treated. A European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) workshop was convened to discuss osteoporosis in men and to provide a report by a panel of experts (the authors). Methods A debate with an expert panel on preselected topics was conducted. Results and Conclusions Although additional fracture data are needed to endorse the clinical care of osteoporosis in men, consensus views were reached on diagnostic criteria and intervention thresholds. Empirical data in men display similarities with data acquired in women, despite pathophysiological differences, which may not be clinically relevant. Men should receive treatment at a similar 10-year fracture probability as in women. The design of mixed studies may reduce the lag between comparable treatments for osteoporosis in women becoming available in men. PMID:23201268

Chronic Kidney Disease, Spirituality and Religiosity: A Systematic Overview with the List of Eligible Studies

PubMed Central

Bragazzi, Nicola Luigi; Puente, Giovanni Del

2013-01-01

Chronic Kidney Disease (CKD) has a tremendous psychological burden, which sometimes is overlooked or underestimated in the daily clinical routine practice, since in the health care process physicians prefer to focus on the objective aspects of the pathology. In this contribution, we make a systematic overview of the relationship between spirituality/religiosity and CKD, an emerging theme which only recently has raised interest from the scientific community despite its importance. We investigate different variables, axis and categories (from the quality of life to customer’s satisfaction, treatment adherence and therapeutic alliance, clinical parameters, as well as overall survival, and coping strategies adopted by the patient). Moreover, we underpin the principal clinically relevant implications (like the possibility of psycho-therapeutic interventions based on the spiritual and religious attitudes of the patient) and we discuss the main gaps, methodological barriers and difficulties in the field, fostering and advocating further research and clinical studies. This last aspect, together with the quality assessment of the studies, will be further explored in the second part of the study. PMID:26973911

Fertility -- A new trend for a global business.

PubMed

Farley, J U

1969-01-01

Cooperation between the public and private sectors in helping control population is possible. The usual public outlet for contraceptives, the clinic, is unsatisfactory for 3 reasons: coverage is sparse; there is no simple, repetitive supply activity; and more immediate medical problems take precedence. The public sector is not conversant with advertising and merchandising techniques and research which aid dissemination of both information and the product. Common marketing notions, e.g., 'trading up' may be relevant, i.e., many new aspects of oral contraceptives, IUDs, had already used conventional methods of contraception. The private sector is less sensitive to the political and religious aspects of contraception than the public sector.

Advanced Multi-Axis Spine Testing: Clinical Relevance and Research Recommendations

PubMed Central

Holsgrove, Timothy P.; Nayak, Nikhil R.; Welch, William C.

2015-01-01

Back pain and spinal degeneration affect a large proportion of the general population. The economic burden of spinal degeneration is significant, and the treatment of spinal degeneration represents a large proportion of healthcare costs. However, spinal surgery does not always provide improved clinical outcomes compared to non-surgical alternatives, and modern interventions, such as total disc replacement, may not offer clinically relevant improvements over more established procedures. Although psychological and socioeconomic factors play an important role in the development and response to back pain, the variation in clinical success is also related to the complexity of the spine, and the multi-faceted manner by which spinal degeneration often occurs. The successful surgical treatment of degenerative spinal conditions requires collaboration between surgeons, engineers, and scientists in order to provide a multi-disciplinary approach to managing the complete condition. In this review, we provide relevant background from both the clinical and the basic research perspectives, which is synthesized into several examples and recommendations for consideration in increasing translational research between communities with the goal of providing improved knowledge and care. Current clinical imaging, and multi-axis testing machines, offer great promise for future research by combining invivo kinematics and loading with in-vitro testing in six degrees of freedom to offer more accurate predictions of the performance of new spinal instrumentation. Upon synthesis of the literature, it is recommended that in-vitro tests strive to recreate as many aspects of the in-vivo environment as possible, and that a physiological preload is a critical factor in assessing spinal biomechanics in the laboratory. A greater link between surgical procedures, and the outcomes in all three anatomical planes should be considered in both the in-vivo and in-vitro settings, to provide data relevant to quality of motion, and stability. PMID:26273552

[Cardiovascular manifestations of human toxocariasis].

PubMed

Bolívar-Mejía, Adrián; Rodríguez-Morales, Alfonso J; Paniz-Mondolfi, Alberto E; Delgado, Olinda

2013-01-01

Toxocariasis is a parasitic infection produced by helminths that cannot reach their adult stage in humans. For their etiological species (Toxocara canis and Toxocara cati), man is a paratenic host. Infection by such helminths can produce a variety of clinical manifestations, such as: visceral larvae migrans syndrome, ocular larvae migrans syndrome and covert toxocariasis. In the visceral larvae migrans syndrome, the organs that are mainly involved include liver, lungs, skin, nervous system, muscles, kidneys and the heart. Regarding the latter, the importance of cardiovascular manifestations in toxocariasis, as well as its clinical relevance, has increasingly begun to be recognized. The current article is based on a systematic information search, focused mainly on the clinical and pathological aspects of cardiovascular manifestations in toxocariasis, including its pathophysiology, laboratory findings, diagnosis and therapeutical options, with the objective of highlighting its importance as a zoonosis and its relevance to the fields of cardiovascular medicine in adults and children. Copyright © 2012 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

Assessing clinical reasoning (ASCLIRE): Instrument development and validation.

PubMed

Kunina-Habenicht, Olga; Hautz, Wolf E; Knigge, Michel; Spies, Claudia; Ahlers, Olaf

2015-12-01

Clinical reasoning is an essential competency in medical education. This study aimed at developing and validating a test to assess diagnostic accuracy, collected information, and diagnostic decision time in clinical reasoning. A norm-referenced computer-based test for the assessment of clinical reasoning (ASCLIRE) was developed, integrating the entire clinical decision process. In a cross-sectional study participants were asked to choose as many diagnostic measures as they deemed necessary to diagnose the underlying disease of six different cases with acute or sub-acute dyspnea and provide a diagnosis. 283 students and 20 content experts participated. In addition to diagnostic accuracy, respective decision time and number of used relevant diagnostic measures were documented as distinct performance indicators. The empirical structure of the test was investigated using a structural equation modeling approach. Experts showed higher accuracy rates and lower decision times than students. In a cross-sectional comparison, the diagnostic accuracy of students improved with the year of study. Wrong diagnoses provided by our sample were comparable to wrong diagnoses in practice. We found an excellent fit for a model with three latent factors-diagnostic accuracy, decision time, and choice of relevant diagnostic information-with diagnostic accuracy showing no significant correlation with decision time. ASCLIRE considers decision time as an important performance indicator beneath diagnostic accuracy and provides evidence that clinical reasoning is a complex ability comprising diagnostic accuracy, decision time, and choice of relevant diagnostic information as three partly correlated but still distinct aspects.

What is a Good Looking Penis? How Women Rate the Penile Appearance of Men with Surgically Corrected Hypospadias.

PubMed

Ruppen-Greeff, Norma Katharina; Weber, Daniel M; Gobet, Rita; Landolt, Markus A

2015-08-01

Some men with corrected hypospadias perceive their penile appearance to be abnormal, although health professionals consider these results satisfactory. The aim of this study was to investigate how relevant women consider single aspects of penile appearance to be. Moreover, we studied whether women perceive hypospadias-affected surgically repaired genitals (HASRGs) to be as normal-looking as circumcised genitals and identified the most relevant predictors that influence whether a penis is perceived as normal. In this cross-sectional study, 105 women in different age groups (age range: 16-20, 25-30, and 40-45 years) completed a standardized questionnaire. Participants had to rate the importance of eight penile aspects and to indicate how normal they found the appearance of standardized photos of 10 HASRGs and of 10 circumcised genitals. Furthermore, they were asked about demographic characteristics and their sexuality. Results showed that women considered the position and shape of the meatus as the least important penile aspect. Furthermore, results showed that HASRGs with distal hypospadias were perceived to be as normal-looking as circumcised genitals, whereas genitals with more proximal hypospadias were perceived as significantly less normal. However, the difference need not be considered clinically relevant, as the effect size was small. Observer-related predictors of a more positive perception of HASRGs were higher age, higher sexual interest, and perceiving the general cosmetic penile appearance as more important and penile length as less important. Overall, women were found to consider the "position and shape of the meatus" as the least important penile aspect. These findings may stimulate reflections regarding the relevance of surgical correction of the meatus in minor forms of hypospadias. In addition, this study indicates that women perceived genitals of men with distal operated hypospadias (which represents the majority of hypospadias) to be as normal as nonaffected, circumcised genitals. © 2015 International Society for Sexual Medicine.

Basics of Compounding: Clinical Pharmaceutics, Part 2.

PubMed

Allen, Loyd V

2016-01-01

This article represents part 2 of a 2-part article on the topic of clinical pharmaceutics. Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Part 1 of this series of articles discussed incompatibilities which can directly affect a clinical outcome and utilized pharmaceutics case examples of the application and importance of clinical pharmaceutics covering different characteristics. Part 2 continues to illustrate the scientific principles and clinical effects involved in clinical pharmaceutics. Also covered in this article are many of the scientific principles in typical to patient care. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

[Phenotypic heterogeneity of chronic obstructive pulmonary disease].

PubMed

Garcia-Aymerich, Judith; Agustí, Alvar; Barberà, Joan A; Belda, José; Farrero, Eva; Ferrer, Antoni; Ferrer, Jaume; Gáldiz, Juan B; Gea, Joaquim; Gómez, Federico P; Monsó, Eduard; Morera, Josep; Roca, Josep; Sauleda, Jaume; Antó, Josep M

2009-03-01

A functional definition of chronic obstructive pulmonary disease (COPD) based on airflow limitation has largely dominated the field. However, a view has emerged that COPD involves a complex array of cellular, organic, functional, and clinical events, with a growing interest in disentangling the phenotypic heterogeneity of COPD. The present review is based on the opinion of the authors, who have extensive research experience in several aspects of COPD. The starting assumption of the review is that current knowledge on the pathophysiology and clinical features of COPD allows us to classify phenotypic information in terms of the following dimensions: respiratory symptoms and health status, acute exacerbations, lung function, structural changes, local and systemic inflammation, and systemic effects. Twenty-six phenotypic traits were identified and assigned to one of the 6 dimensions. For each dimension, a summary is provided of the best evidence on the relationships among phenotypic traits, in particular among those corresponding to different dimensions, and on the relationship between these traits and relevant events in the natural history of COPD. The information has been organized graphically into a phenotypic matrix where each cell representing a pair of phenotypic traits is linked to relevant references. The information provided has the potential to increase our understanding of the heterogeneity of COPD phenotypes and help us plan future studies on aspects that are as yet unexplored.

[Depersonalization and déjà vu experiences: prevalences in nonclinical samples].

PubMed

Probst, P; Jansen, J

1991-01-01

According to the relevant psychological and psychiatric literature, depersonalization and déjà vu experiences are usually viewed as symptoms of severe psychiatric or neurological disorders, especially in schizophrenia, depression and epilepsy. Studies of these phenomena in non-clinical populations are rate. In this article we present the results of several epidemiological investigations. On the basis of survey and interview research, quantitative and qualitative aspects of both phenomena were assessed, as well as the relations with personality variables like emotionality. The results indicate prevalence rates up to 80 percent in non-clinical populations. Based on epidemiological considerations, the question of differentiation between clinical and non-clinical forms of depersonalization and déjà vu is discussed.

CPOE system design aspects and their qualitative effect on usability.

PubMed

Khajouei, Reza; Jaspers, Monique W M

2008-01-01

Although many studies have discussed the benefits of Computerized Provider Order Entry (CPOE) systems, their configuration can have a great impact on clinicians' adoption of these systems. Poorly designed CPOE systems can lead to usability problems, users' dissatisfaction and may disrupt normal flow of clinical activities. This paper reports on a literature review focused on the identification of CPOE medication systems' design aspects that impact CPOE systems' usability and create opportunities for medication errors. Our review is based on a systematic literature search in PubMed, EMBASE and Ovid MEDLINE for relevant publications from 1986-2006. We categorized the design aspects extracted from relevant publications into six different groups: 1) timing of alerts, 2) log in/out procedures, 3) pick lists and drop down menus, 4) clues and guidelines, 5) documentation and data entry options, and 6) screen display and layout. Our review shows that the manner in which a CPOE system is configured can have a high impact on ease of system use, task behavior of clinicians in ordering drugs, and medication errors. Characterization of consequences associated with certain CPOE design aspects provides insight into how CPOE system designs can be improved to enhance physicians' adoption of these systems and their success. Recommendations are provided to enable CPOE system designers to create CPOE systems that are not only more user friendly and efficient but safer.

VR-CoDES and patient-centeredness. The intersection points between a measure and a concept.

PubMed

Del Piccolo, Lidia

2017-11-01

The Verona Coding Definitions of Emotional sequences (VR-CoDES) system has been applied in a wide range of studies, in some of these, because of its attention on healthcare provider's ability to respond to patient emotions, it has been used as a proxy of patient-centeredness. The paper aims to discuss how the VR-CoDES can contribute to the broader concept of patient-centeredness and its limitations. VR-CoDES and patient-centeredness concept are briefly described, trying to detect commonalities and distinctions. The VR-CoDES dimensions of Explicit/non explicit responding and Providing or Reducing Space are analysed in relation to relevant aspects of patient-centred communication. Emotional aspects are encompassed within patient-centeredness model, but they represent only one of the numerous dimensions that contribute to define patient-centeredness as well as Explicit/non explicit responding and Providing or Reducing Space serve different functions during communication. The VR-CoDES can contribute to operationalize the description of emotional aspects emerging in a consultation, by inducing coders to adopt a factual attitude in assessing how health providers react to patient's expression of emotions. To better define empirically which measure affective aspects and dimensions of health provider responses are relevant and may contribute to patient-centeredness in different clinical settings. Copyright © 2017. Published by Elsevier B.V.

Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them

PubMed Central

Rousseau, Cécile F.; Mačiulaitis, Romaldas; Śladowski, Dariusz; Narayanan, Gopalan

2018-01-01

Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs). The many challenges in translation posed by this class of products include aspects covering: manufacturing, non-clinical development plan as relevant to clinical trial, marketing authorization, and reimbursement. In this context, the term translation refers to the relevance of non-clinical data in relation to how it impacts on appropriate and efficient clinical development. In order to successfully overcome these challenges, a clear understanding of the requirements and expectations of all the stakeholders is critical. This article aims to cover the potential challenges related to such translation and suggested approaches to find solutions based on experience and learnings from the perspective of European Union. While commercial challenges have a significant impact on the ATMPs in general, it is considered outside the scope of this article. However, by adopting a strong scientific basis for translation as suggested in this article, it is likely such an approach would help rather than harm successful real world clinical use of ATMPs.

PROCEEDINGS OF THE CONFERENCE ON RADIOIODINE SPONSORED BY THE ARGONNE CANCER RESEARCH HOSPITAL, UNITED STATES ATOMIC ENERGY COMMISSION, AND THE CLINICS OF THE UNIVERSITY OF CHICAGO, NOVEMBER 5 AND 6, 1956, CHICAGO, ILLINOIS

DOE Office of Scientific and Technical Information (OSTI.GOV)

Clark, D.E. ed.

1958-10-31

Applications of the various iodine isotopes in diagnosis and therapy are discussed. Problems of dosimetry and radiation exposure to patients and hospital personnel are considered. Some quantitative aspects of radiation damage in mammals relevant to the clinical use of radioiodine are reviewed. Emphasis is placed on applications of iodine-131 in diagnosis and therapy of hyperthyroidism and hypothyroidism; in the treatmeat of thyroid carcinoma; and in thyroid ablation for cardiac disease. 54 references. (C.H.)

Lacan and Adolescence: The Contemporary Clinic of the "Sexual Non-rapport" and Pornography.

PubMed

Ouvry, Olivier

2017-01-01

This article explores two clinical phenomena-pornography and conspiracy thinking-that are highly relevant today and can be observed specifically among adolescent boys in the early stages of post-puberty: conspiracy thinking and the viewing of pornographic videos. It shows that the Lacanian concepts of the Real (of puberty) and the sexual non-rapport help us understand the psychopathological aspects of these two phenomena. Watching pornographic material becomes equivalent to a conspiracy theory about the sexual non-rapport; both in fact deny the effect of what puberty introduces as radically new.

Lacan and Adolescence: The Contemporary Clinic of the “Sexual Non-rapport” and Pornography

PubMed Central

Ouvry, Olivier

2018-01-01

This article explores two clinical phenomena—pornography and conspiracy thinking—that are highly relevant today and can be observed specifically among adolescent boys in the early stages of post-puberty: conspiracy thinking and the viewing of pornographic videos. It shows that the Lacanian concepts of the Real (of puberty) and the sexual non-rapport help us understand the psychopathological aspects of these two phenomena. Watching pornographic material becomes equivalent to a conspiracy theory about the sexual non-rapport; both in fact deny the effect of what puberty introduces as radically new. PMID:29467683

The First Cut Is the Deepest: The History and Development of Safe Treatments for Wound Healing and Tissue Repair.

PubMed

Hobson, David W; Schuh, JoAnn C L; Zurawski, Daniel V; Wang, Jianyong; Arbabi, Sam; McVean, Maralee; Funk, Kathleen A

2016-09-01

As the skin is the primary barrier to infection, the importance of wound healing has been understood since ancient times. This article provides a synopsis on the symposium presentations focusing on how wounds were traditionally treated, what models and pathology endpoints exist to study wound healing, special considerations for wound healing studies, an overview of regulatory aspects of new pharmaceutical and medical device development, and the clinical relevance of such models. The clinical treatment of small and large wounds is also considered. © The Author(s) 2016.

Preliminary clinical results with the ISL laser

NASA Astrophysics Data System (ADS)

Hoppeler, Thomas; Gloor, Balder

1992-08-01

The ISL laser (Intelligent Surgical Lasers, Inc.), a Nd:YLF picosecond pulse laser, is currently being used under investigational device exemption to perform microsurgery of the anterior segment of the eye. At different study sites procedures for cataract fragmentation and iridotomy, as well as for posterior capsulotomy after cataract surgery, are under evaluation. Other potential applications include: sclerostomy ab interno, the cutting of membranes in the anterior and posterior segment of the eye; corneal incisions; and corneal intrastromal effects. We discuss various clinically relevant aspects of the use of this picosecond laser. An overview of different computer controlled laser patterns is given.

Blood Tests for People with Severe Learning Disabilities Receiving Dental Treatment under General Anaesthesia.

PubMed

Clough, Stacey; Shehabi, Zahra; Morgan, Claire; Sheppey, Claire

2016-11-01

People with learning disabilities (LDs) have poorer health than their non-disabled peers due to failures in reasonable adjustments. One hundred patients with severe LD and challenging behaviour attended for dental treatment under GA, during which routine blood testing was provided. Communication with general medical practitioners (GMPs) and blood test results were evaluated, showing poor communication with GMPs and significant undiagnosed disease among this group. Blood tests generate similar costs in primary and secondary care but a holistic approach to care under GA reduces expenses brought by lost clinical time and resources due to complex behaviours in an out-patient setting. Clinical relevance: This article discusses a holistic approach to healthcare for people with severe LD, including patient outcomes, financial and resource implications, and offers practical guidance on venepuncture technique, which is relevant to many aspects of both community and hospital dental practice.

Amnesia and crime.

PubMed

Bourget, Dominique; Whitehurst, Laurie

2007-01-01

Amnesia for serious offenses has important legal implications, particularly regarding its relevance in the contexts of competency to stand trial and criminal responsibility. Forensic psychiatrists and other mental health professionals are often required to provide expert testimony regarding amnesia in defendants. However, the diagnosis of amnesia presents a challenge, as claims of memory impairment may stem from organic disease, dissociative amnesia, amnesia due to a psychotic episode, or malingered amnesia. We review the theoretical, clinical, and legal perspectives on amnesia in relation to crime and present relevant cases that demonstrate several types of crime-related amnesia and their legal repercussions. Consideration of the presenting clinical features of crime-related amnesia may enable a fuller understanding of the different types of amnesia and assist clinicians in the medico-legal assessment and diagnosis of the claimed memory impairment. The development of a profile of aspects characteristic of crime-related amnesia would build toward establishing guidelines for the assessment of amnesia in legal contexts.

Medulloblastoma: Tumor Biology and Relevance to Treatment and Prognosis Paradigm.

PubMed

Coluccia, Daniel; Figuereido, Carlyn; Isik, Semra; Smith, Christian; Rutka, James T

2016-05-01

Medulloblastoma is a malignant embryonic brain tumor arising in the posterior fossa and typically occurring in pediatric patients. Current multimodal treatment regimes have significantly improved the survival rates; however, a marked heterogeneity in therapy response is observed, and one third of all patients die within 5 years after diagnosis. Large-scale genetic and transcriptome analysis revealed four medulloblastoma subgroups (WNT, SHH, Group 3, and Group 4) associated with different demographic parameters, tumor manifestation, and clinical behavior. Future treatment protocols will integrate molecular classification schemes to evaluate subgroup-specific intensification or de-escalation of adjuvant therapies aimed to increase tumor control and reduce iatrogenic induced morbidity. Furthermore, the identification of genetic drivers allows assessing target therapies in order to increase the chemotherapeutic armamentarium. This review highlights the biology behind the current classification system and elucidates relevant aspects of the disease influencing forthcoming clinical trials.

Legal and ethical issues in research.

PubMed

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-09-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

Cell sheet engineering: a unique nanotechnology for scaffold-free tissue reconstruction with clinical applications in regenerative medicine.

PubMed

Elloumi-Hannachi, I; Yamato, M; Okano, T

2010-01-01

Cell sheet technology (CST) is based on the use of thermoresponsive polymers, poly(N-isopropylacrylamide) (PIPAAm). The surface of PIPAAms is formulated in such a way as to make its typical thickness <100 nm. In this review, we first focus on how the methods of PIPAAm-grafted surface preparations and functionalization are important to be able to harvest a functional cell sheet, to be further transplanted. Then, we present aspects of tissue mimics and three-dimensional reconstruction of a tissue in vitro. Finally, we give an overview of clinical applications and clinically relevant animal experimentations of the technology, such as cardiomyopathy, visual acuity, periodonty, oesophageal ulcerations and type 1 diabetes.

Female Pattern Hair Loss: a clinical and pathophysiological review*

PubMed Central

Ramos, Paulo Müller; Miot, Hélio Amante

2015-01-01

Female Pattern Hair Loss or female androgenetic alopecia is the main cause of hair loss in adult women and has a major impact on patients' quality of life. It evolves from the progressive miniaturization of follicles that lead to a subsequent decrease of the hair density, leading to a non-scarring diffuse alopecia, with characteristic clinical, dermoscopic and histological patterns. In spite of the high frequency of the disease and the relevance of its psychological impact, its pathogenesis is not yet fully understood, being influenced by genetic, hormonal and environmental factors. In addition, response to treatment is variable. In this article, authors discuss the main clinical, epidemiological and pathophysiological aspects of female pattern hair loss. PMID:26375223

Economic aspects of the new Spanish laws on pharmaceutical preparations.

PubMed

Antoñanzas, Fernando; Oliva, Juan; Pinillos, Mariola; Juàrez, Carmelo

2007-09-01

In this article, we provide readers with a summary of the main economic features of the recently approved Spanish law regarding pharmaceutical preparations entitled the Law of Guarantees and Rational Use of Pharmaceuticals and Health Products (Law 29/2006 of July 26th). We review information on pricing, reference pricing, promotion of generic drugs, public reimbursement, patients' contributions, and penalties. Other aspects of minor economic relevance such as the information on prices shown in the packs and the transparency on the results of clinical trials irrespective of whether these are positive or not, are not addressed in this paper. We conclude with some observations on the new horizons opened up by this new legal framework. We have not included any detailed references to the new law; we merely wish to comment on certain aspects of its application.

Building the body: active learning laboratories that emphasize practical aspects of anatomy and integration with radiology.

PubMed

Zumwalt, Ann C; Lufler, Rebecca S; Monteiro, Joseph; Shaffer, Kitt

2010-01-01

Active learning exercises were developed to allow advanced medical students to revisit and review anatomy in a clinically meaningful context. In our curriculum, students learn anatomy two to three years before they participate in the radiology clerkship. These educational exercises are designed to review anatomy content while highlighting its relevance to the study of radiology. Laboratory exercises were developed using inexpensive materials in the form of hands-on stations designed for use by students working together in small groups. Station exercises include model building, exploring relevant radiological imaging, and practicing clinical techniques. Students are encouraged to move from abstract conceptualization of the anatomy using models to applying knowledge to living tissues by using a portable ultrasound to explore superficial anatomy on each other. Stations are designed to integrate knowledge and reemphasize concepts in different contexts, so that upon completion students have a reinforced understanding of the three-dimensional anatomy of the region in question, the appearance of the anatomy on radiological images, and an appreciation of the relevance of the anatomy to radiological procedures. (c) 2010 American Association of Anatomists.

I sleep, because we sleep: a synthesis on the role of culture in sleep behavior research.

PubMed

Airhihenbuwa, C O; Iwelunmor, J I; Ezepue, C J; Williams, N J; Jean-Louis, G

2016-02-01

The aim of this study was to synthesize the literature on the cultural aspects of sleep and their relevance to behavioral sleep research. A narrative synthesis of the existing literature on sleep was conducted with a focus on its biological, sociological, political, and anthropological aspects. This synthesis was guided by the PEN-3 cultural model, developed by the primary author. The findings highlight the cross-cultural contexts within which people sleep and the role of varied sleeping arrangements in influencing sleep behavior and perspectives. Furthermore, the contexts in which sleep occurs, coupled with the influence of the family, and the positive aspects of sleep helped illustrate why cultural aspects of sleep are vital for a broader understanding of sleep. The authors conclude by highlighting the need to integrate studies on the biological, sociological, and political aspects of sleep. Our examination of the literature strongly suggests that careful assessment of epidemiological and clinical sleep data should consider the cultural aspects of sleep as well as the context in which sleep occurs, the role of the family, and positive aspects of sleep. Copyright © 2015 Elsevier B.V. All rights reserved.

Psychosocial Aspects of Bruxism: The Most Paramount Factor Influencing Teeth Grinding

PubMed Central

Wieckiewicz, Mieszko; Paradowska-Stolarz, Anna; Wieckiewicz, Wlodzimierz

2014-01-01

In clinical practice, patients suffering from an occlusal parafunctional activity have increased. It can be observed that a negative influence of environment aggravates patient's health. The aim of this paper is to present the impact of environment and development of human civilization on the prevalence of bruxism and the correlation between them. The authors grasp the most relevant aspects of psychological and anthropological factors changing over time as well as their interactions and describe a relationship between chronic stress and bruxism. Current literature shows how contemporary lifestyle, working environment, diet, and habits influence the patient's psychoemotional situation and the way these factors affect the occluso-muscle condition. PMID:25101282

Substance Abuse Prevention, Assessment, and Treatment for Lesbian, Gay, Bisexual, and Transgender Youth.

PubMed

Aromin, Romulo Alcalde

2016-12-01

Knowing how to manage substance abuse in all youth is an important aspect of pediatric care, including providing clinically appropriate anticipatory guidance, monitoring, assessment, and treatment. Although most lesbian, gay, bisexual, and transgender (LGBT) youth do not abuse substances, as a group they experience unique challenges in self-identity development that put them at an increased risk for substance abuse. This article addresses prevention and management of substance use in LGBT youth relevant to pediatrics and allied professions as an aspect of their overall health care. It reviews basic information about substance abuse in youth and special considerations for LGBT youth. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinico-Pathologic Relevance of Survivin Splice Variant Expression in Cancer

PubMed Central

de Necochea-Campion, Rosalia; Chen, Chien-Shing; Mirshahidi, Saied; Howard, Frank D.; Wall, Nathan R.

2013-01-01

Survivin is a member of the inhibitor of apoptosis (IAP) family and has multifunctional properties that include aspects of proliferation, invasion and cell survival control. Survivin is a promising candidate for targeted cancer therapy as its expression is associated with poor clinical outcome, more aggressive clinico-pathologic features, and resistance to radiation and chemotherapy. In the present review the different properties of the Survivin splice variants are discussed and their activities correlated with different aspects of cancer cell biology, to include subcellular location. Special emphasis is placed on our current understanding of these Survivin splice variants influence on each other and on the phenotypic responses to therapy that they may control. PMID:23791888

Premorbid personality characteristics and attachment style moderate the effect of injury severity on occupational outcome in traumatic brain injury: another aspect of reserve.

PubMed

Sela-Kaufman, Michal; Rassovsky, Yuri; Agranov, Eugenia; Levi, Yifat; Vakil, Eli

2013-01-01

The concept of "reserve" has been proposed to account for the mismatch between brain pathology and its clinical expression. Prior efforts to characterize this concept focused mostly on brain or cognitive reserve measures. The present study was a preliminary attempt to evaluate premorbid personality and emotional aspects as potential moderators in moderate-to-severe traumatic brain injury. Using structural equation modeling and multiple regression analyses, we found that premorbid personality characteristics provided the most robust moderator of injury severity on occupational outcome. Findings offer preliminary support for premorbid personality features as another relevant reserve construct in predicting outcome in this population.

Research perspectives in first metatarsal osteotomy and fixation stability.

PubMed

Landsman, A S; Higgins, K R; Lampe, N

1996-07-01

Well-designated research is required to provide clinical guidance by validation of old and new methods. Variables, including technologic advancement in surgical techniques, diagnosis, shoe design, and immobilization all contribute to the challenge of investigating surgical procedures of the foot. This article highlights some of the relevant research pertaining to first metatarsal osteotomies and internal fixation and provides direction for potential, future research. Numerous aspects about the research techniques involved are discussed.

How do Supervising Clinicians of a University Hospital and Associated Teaching Hospitals Rate the Relevance of the Key Competencies within the CanMEDS Roles Framework in Respect to Teaching in Clinical Clerkships?

PubMed

Jilg, Stefanie; Möltner, Andreas; Berberat, Pascal; Fischer, Martin R; Breckwoldt, Jan

2015-01-01

In German-speaking countries, the physicians' roles framework of the "Canadian Medical Education Directives for Specialists" (CanMEDS) is increasingly used to conceptualize postgraduate medical education. It is however unclear, whether it may also be applied to the final year of undergraduate education within clinical clerkships, called "Practical Year" (PY). Therefore, the aim of this study was to explore how clinically active physicians at a university hospital and at associated teaching hospitals judge the relevance of the seven CanMEDS roles (and their (role-defining) key competencies) in respect to their clinical work and as learning content for PY training. Furthermore, these physicians were asked whether the key competencies were actually taught during PY training. 124 physicians from internal medicine and surgery rated the relevance of the 28 key competencies of the CanMEDS framework using a questionnaire. For each competency, following three aspects were rated: "relevance for your personal daily work", "importance for teaching during PY", and "implementation into actual PY teaching". In respect to the main study objective, all questionnaires could be included into analysis. All seven CanMEDS roles were rated as relevant for personal daily work, and also as important for teaching during PY. Furthermore, all roles were stated to be taught during actual PY training. The roles "Communicator", "Medical Expert", and "Collaborator" were rated as significantly more important than the other roles, for all three sub-questions. No differences were found between the two disciplines internal medicine and surgery, nor between the university hospital and associated teaching hospitals. Participating physicians rated all key competencies of the CanMEDS model to be relevant for their personal daily work, and for teaching during PY. These findings support the suitability of the CanMEDS framework as a conceptual element of PY training.

How do Supervising Clinicians of a University Hospital and Associated Teaching Hospitals Rate the Relevance of the Key Competencies within the CanMEDS Roles Framework in Respect to Teaching in Clinical Clerkships?

PubMed Central

Jilg, Stefanie; Möltner, Andreas; Berberat, Pascal; Fischer, Martin R.; Breckwoldt, Jan

2015-01-01

Background and aim: In German-speaking countries, the physicians’ roles framework of the “Canadian Medical Education Directives for Specialists” (CanMEDS) is increasingly used to conceptualize postgraduate medical education. It is however unclear, whether it may also be applied to the final year of undergraduate education within clinical clerkships, called “Practical Year” (PY). Therefore, the aim of this study was to explore how clinically active physicians at a university hospital and at associated teaching hospitals judge the relevance of the seven CanMEDS roles (and their (role-defining) key competencies) in respect to their clinical work and as learning content for PY training. Furthermore, these physicians were asked whether the key competencies were actually taught during PY training. Methods: 124 physicians from internal medicine and surgery rated the relevance of the 28 key competencies of the CanMEDS framework using a questionnaire. For each competency, following three aspects were rated: “relevance for your personal daily work”, “importance for teaching during PY”, and “implementation into actual PY teaching”. Results: In respect to the main study objective, all questionnaires could be included into analysis. All seven CanMEDS roles were rated as relevant for personal daily work, and also as important for teaching during PY. Furthermore, all roles were stated to be taught during actual PY training. The roles “Communicator”, “Medical Expert”, and “Collaborator” were rated as significantly more important than the other roles, for all three sub-questions. No differences were found between the two disciplines internal medicine and surgery, nor between the university hospital and associated teaching hospitals. Conclusion: Participating physicians rated all key competencies of the CanMEDS model to be relevant for their personal daily work, and for teaching during PY. These findings support the suitability of the CanMEDS framework as a conceptual element of PY training. PMID:26413171

An enhancement of ROC curves made them clinically relevant for diagnostic-test comparison and optimal-threshold determination.

PubMed

Subtil, Fabien; Rabilloud, Muriel

2015-07-01

The receiver operating characteristic curves (ROC curves) are often used to compare continuous diagnostic tests or determine the optimal threshold of a test; however, they do not consider the costs of misclassifications or the disease prevalence. The ROC graph was extended to allow for these aspects. Two new lines are added to the ROC graph: a sensitivity line and a specificity line. Their slopes depend on the disease prevalence and on the ratio of the net benefit of treating a diseased subject to the net cost of treating a nondiseased one. First, these lines help researchers determine the range of specificities within which test comparisons of partial areas under the curves is clinically relevant. Second, the ROC curve point the farthest from the specificity line is shown to be the optimal threshold in terms of expected utility. This method was applied: (1) to determine the optimal threshold of ratio specific immunoglobulin G (IgG)/total IgG for the diagnosis of congenital toxoplasmosis and (2) to select, among two markers, the most accurate for the diagnosis of left ventricular hypertrophy in hypertensive subjects. The two additional lines transform the statistically valid ROC graph into a clinically relevant tool for test selection and threshold determination. Copyright © 2015 Elsevier Inc. All rights reserved.

Pulmonary atelectasis in newborns with clinically treatable diseases who are on mechanical ventilation: clinical and radiological aspects.

PubMed

Dominguez, Mariana Chiaradia; Alvares, Beatriz Regina

2018-01-01

To analyze the radiological aspects of pulmonary atelectasis in newborns on mechanical ventilation and treated in an intensive care unit, associating the characteristics of atelectasis with the positioning of the head and endotracheal tube seen on the chest X-ray, as well as with the clinical variables. This was a retrospective cross-sectional study of 60 newborns treated between 1985 and 2015. Data were collected from medical records and radiology reports. To identify associations between variables, we used Fisher's exact test. The level of significance was set at p < 0.05. The clinical characteristics associated with improper positioning of the endotracheal tube were prematurity and a birth weight of less than 1000 g. Among the newborns evaluated, the most common comorbidity was hyaline membrane disease. Atelectasis was seen most frequently in the right upper lobe, although cases of total atelectasis were more common in the left lung. Malpositioning of the head showed a trend toward an association with atelectasis in the left upper lobe. Pulmonary atelectasis is a common complication in newborns on mechanical ventilation. Radiological evaluation of the endotracheal tube placement provides relevant information for the early correction of this condition.

Practical aspects of NGS-based pathways analysis for personalized cancer science and medicine

PubMed Central

Paleeva, Anna; Kremenetskaya, Olga; Vinogradov, Dmitriy

2016-01-01

Nowadays, the personalized approach to health care and cancer care in particular is becoming more and more popular and is taking an important place in the translational medicine paradigm. In some cases, detection of the patient-specific individual mutations that point to a targeted therapy has already become a routine practice for clinical oncologists. Wider panels of genetic markers are also on the market which cover a greater number of possible oncogenes including those with lower reliability of resulting medical conclusions. In light of the large availability of high-throughput technologies, it is very tempting to use complete patient-specific New Generation Sequencing (NGS) or other “omics” data for cancer treatment guidance. However, there are still no gold standard methods and protocols to evaluate them. Here we will discuss the clinical utility of each of the data types and describe a systems biology approach adapted for single patient measurements. We will try to summarize the current state of the field focusing on the clinically relevant case-studies and practical aspects of data processing. PMID:27191992

Personalized Medicine in a New Genomic Era: Ethical and Legal Aspects.

PubMed

Shoaib, Maria; Rameez, Mansoor Ali Merchant; Hussain, Syed Ather; Madadin, Mohammed; Menezes, Ritesh G

2017-08-01

The genome of two completely unrelated individuals is quite similar apart from minor variations called single nucleotide polymorphisms which contribute to the uniqueness of each and every person. These single nucleotide polymorphisms are of great interest clinically as they are useful in figuring out the susceptibility of certain individuals to particular diseases and for recognizing varied responses to pharmacological interventions. This gives rise to the idea of 'personalized medicine' as an exciting new therapeutic science in this genomic era. Personalized medicine suggests a unique treatment strategy based on an individual's genetic make-up. Its key principles revolve around applied pharmaco-genomics, pharmaco-kinetics and pharmaco-proteomics. Herein, the ethical and legal aspects of personalized medicine in a new genomic era are briefly addressed. The ultimate goal is to comprehensively recognize all relevant forms of genetic variation in each individual and be able to interpret this information in a clinically meaningful manner within the ambit of ethical and legal considerations. The authors of this article firmly believe that personalized medicine has the potential to revolutionize the current landscape of medicine as it makes its way into clinical practice.

Evidence and Function Relevance of Native DOR-MOR Heteromers.

PubMed

Cahill, Catherine M; Ong, Edmund

2018-04-10

Opioid receptors are the sites of action for morphine and most other clinically used opioid drugs. Abundant evidence now demonstrates that different opioid receptor types can physically associate to form heteromers. Owing to their constituent monomers' involvement in analgesia, mu/delta opioid receptor (M/DOR) heteromers have been a particular focus of attention. Understandings of the physiological relevance and indisputable proof of M/DOR formation in vivo are still evolving. This aspect of the field has been slow to progress in large part by the limitations of most available experimental models; recently however, promising progress is being made. As a result, the long-repeated promise of opioid receptor heteromers as selective therapeutic targets is now being realized.

Biocompatibility of biomaterials - Lessons learned and considerations for the design of novel materials.

PubMed

Schmalz, Gottfried; Galler, Kerstin M

2017-04-01

Biocompatibility of dental materials has gained increasing interest during recent decades. Meanwhile, legal regulations and standard test procedures are available to evaluate biocompatibility. Herein, these developments will be exemplarily outlined and some considerations for the development of novel materials will be provided. Different aspects including test selection, release of substances, barriers, tissue healing, antibacterial substances, nanoparticles and environmental aspects will be covered. The provided information is mainly based on a review of the relevant literature in international peer reviewed journals, on regulatory documents and on ISO standards. Today, a structured and systematic approach for demonstrating biocompatibility from both a scientific and regulatory point of view is based on a clinical risk assessment in an early stage of material development. This includes the analysis of eluted substances and relevant barriers like dentin or epithelium. ISO standards 14971, 10993, and 7405 specify the modes for clinical risk assessment, test selection and test performance. In contact with breached tissues, materials must not impair the healing process. Antibacterial effects should be based on timely controllable substances or on repellant surfaces. Nanoparticles are produced by intraoral grinding irrespective of the content of nanoparticles in the material, but apparently at low concentrations. Concerns regarding environmental aspects of mercury from amalgam can be met by amalgam separating devices. The status for other materials (e.g. bisphenol-A in resin composites) needs to be evaluated. Finally, the public interest for biocompatibility issues calls for a suitable strategy of risk communication. A wise use of the new tools, especially the clinical risk assessment should aim at preventing the patients, professionals and the environment from harm but should not block the development of novel materials. However, biocompatibility must always be weighed against the beneficial effects of materials in curing/preventing oral diseases. Copyright © 2017. Published by Elsevier Ltd.

Toxoplasmosis – Awareness and knowledge among medical doctors in Nigeria

PubMed Central

Efunshile, Akinwale Michael; Elikwu, Charles John

2017-01-01

Toxoplasma gondii is a zoonotic parasite causing high disease burden worldwide. A One Health approach is needed to understand, prevent, and control toxoplasmosis, while knowledge gaps in the One Health aspects have been identified among medical professionals in earlier studies. As a One Health collaboration between veterinary and medical fields, we surveyed the knowledge on toxoplasmosis among medical doctors in Nigeria. The knowledge questions, which the participants answered without consulting literature and colleagues, covered epidemiological One Health aspects as well as clinical interspecialty aspects of T. gondii infections. Altogether 522 medical doctors from four tertiary hospitals completed the questionnaire. The mean number of correct answers in the knowledge questions was 7.5, and 8.4% of the participants selected at least 12 of the 17 correct answers. The proportion of medical doctors scoring such a high score was significantly higher among those who reported having seen a case of clinical toxoplasmosis than in those who did not. While 62% of the medical doctors participating in our study knew that cats can shed T. gondii in their feces, 36% incorrectly suggested that humans could do that too. That T. gondii infection can be meatborne was known by 69%, but that it can be also waterborne only by 28% of the medical doctors participating in our study. Most of the medical doctors, 78%, knew that clinical toxoplasmosis may involve the central nervous system, while only 37% answered that it can involve the eyes. Our results suggested knowledge gaps, which need to be addressed in Continuous Medical Education. The identified gaps included both intersectoral One Health aspects and interspecialty aspects: For prevention and management of toxoplasmosis, knowing the main transmission routes and that the parasite can affect several organs is relevant. PMID:29261738

Toxoplasmosis - Awareness and knowledge among medical doctors in Nigeria.

PubMed

Efunshile, Akinwale Michael; Elikwu, Charles John; Jokelainen, Pikka

2017-01-01

Toxoplasma gondii is a zoonotic parasite causing high disease burden worldwide. A One Health approach is needed to understand, prevent, and control toxoplasmosis, while knowledge gaps in the One Health aspects have been identified among medical professionals in earlier studies. As a One Health collaboration between veterinary and medical fields, we surveyed the knowledge on toxoplasmosis among medical doctors in Nigeria. The knowledge questions, which the participants answered without consulting literature and colleagues, covered epidemiological One Health aspects as well as clinical interspecialty aspects of T. gondii infections. Altogether 522 medical doctors from four tertiary hospitals completed the questionnaire. The mean number of correct answers in the knowledge questions was 7.5, and 8.4% of the participants selected at least 12 of the 17 correct answers. The proportion of medical doctors scoring such a high score was significantly higher among those who reported having seen a case of clinical toxoplasmosis than in those who did not. While 62% of the medical doctors participating in our study knew that cats can shed T. gondii in their feces, 36% incorrectly suggested that humans could do that too. That T. gondii infection can be meatborne was known by 69%, but that it can be also waterborne only by 28% of the medical doctors participating in our study. Most of the medical doctors, 78%, knew that clinical toxoplasmosis may involve the central nervous system, while only 37% answered that it can involve the eyes. Our results suggested knowledge gaps, which need to be addressed in Continuous Medical Education. The identified gaps included both intersectoral One Health aspects and interspecialty aspects: For prevention and management of toxoplasmosis, knowing the main transmission routes and that the parasite can affect several organs is relevant.

Moderate efficiency of clinicians' predictions decreased for blurred clinical conditions and benefits from the use of BRASS index. A longitudinal study on geriatric patients' outcomes.

PubMed

Signorini, Giulia; Dagani, Jessica; Bulgari, Viola; Ferrari, Clarissa; de Girolamo, Giovanni

2016-01-01

Accurate prognosis is an essential aspect of good clinical practice and efficient health services, particularly for chronic and disabling diseases, as in geriatric populations. This study aims to examine the accuracy of clinical prognostic predictions and to devise prediction models combining clinical variables and clinicians' prognosis for a geriatric patient sample. In a sample of 329 consecutive older patients admitted to 10 geriatric units, we evaluated the accuracy of clinicians' prognosis regarding three outcomes at discharge: global functioning, length of stay (LoS) in hospital, and destination at discharge (DD). A comprehensive set of sociodemographic, clinical, and treatment-related information were also collected. Moderate predictive performance was found for all three outcomes: area under receiver operating characteristic curve of 0.79 and 0.78 for functioning and LoS, respectively, and moderate concordance, Cohen's K = 0.45, between predicted and observed DD. Predictive models found the Blaylock Risk Assessment Screening Score together with clinicians' judgment relevant to improve predictions for all outcomes (absolute improvement in adjusted and pseudo-R(2) up to 19%). Although the clinicians' estimates were important factors in predicting global functioning, LoS, and DD, more research is needed regarding both methodological aspects and clinical measurements, to improve prognostic clinical indices. Copyright © 2016 Elsevier Inc. All rights reserved.

The importance of a two-step impression procedure for complete denture fabrication: a systematic review of the literature.

PubMed

Regis, R R; Alves, C C S; Rocha, S S M; Negreiros, W A; Freitas-Pontes, K M

2016-10-01

The literature has questioned the real need for some clinical and laboratory procedures considered essential for achieving better results for complete denture fabrication. The aim of this study was to review the current literature concerning the relevance of a two-step impression procedure to achieve better clinical results in fabricating conventional complete dentures. Through an electronic search strategy of the PubMed/MEDLINE database, randomised controlled clinical trials which compared complete denture fabrication in adults in which one or two steps of impressions occurred were identified. The selections were made by three independent reviewers. Among the 540 titles initially identified, four studies (seven published papers) reporting on 257 patients evaluating aspects such as oral health-related quality of life, patient satisfaction with dentures in use, masticatory performance and chewing ability, denture quality, direct and indirect costs were considered eligible. The quality of included studies was assessed according to the Cochrane guidelines. The clinical studies considered for this review suggest that a two-step impression procedure may not be mandatory for the success of conventional complete denture fabrication regarding a variety of clinical aspects of denture quality and patients' perceptions of the treatment. © 2016 John Wiley & Sons Ltd.

Aspects of matrix effects in applications of liquid chromatography-mass spectrometry to forensic and clinical toxicology--a review.

PubMed

Peters, Frank T; Remane, Daniela

2012-06-01

In the last decade, liquid chromatography coupled to (tandem) mass spectrometry (LC-MS(-MS)) has become a versatile technique with many routine applications in clinical and forensic toxicology. However, it is well-known that ionization in LC-MS(-MS) is prone to so-called matrix effects, i.e., alteration in response due to the presence of co-eluting compounds that may increase (ion enhancement) or reduce (ion suppression) ionization of the analyte. Since the first reports on such matrix effects, numerous papers have been published on this matter and the subject has been reviewed several times. However, none of the existing reviews has specifically addressed aspects of matrix effects of particular interest and relevance to clinical and forensic toxicology, for example matrix effects in methods for multi-analyte or systematic toxicological analysis or matrix effects in (alternative) matrices almost exclusively analyzed in clinical and forensic toxicology, for example meconium, hair, oral fluid, or decomposed samples in postmortem toxicology. This review article will therefore focus on these issues, critically discussing experiments and results of matrix effects in LC-MS(-MS) applications in clinical and forensic toxicology. Moreover, it provides guidance on performance of studies on matrix effects in LC-MS(-MS) procedures in systematic toxicological analysis and postmortem toxicology.

Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Freitas, C S; Marcon, R; Schwanke, R C; Siqueira, J M; Calixto, J B

2016-10-24

This review presents a historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies. Collectively, improving these aspects will certainly contribute to the robustness of both scientific publications and the translation of new substances to clinical development.

Development of Clinically Relevant Implantable Pressure Sensors: Perspectives and Challenges

PubMed Central

Clausen, Ingelin; Glott, Thomas

2014-01-01

This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians. Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported. PMID:25248071

Development of clinically relevant implantable pressure sensors: perspectives and challenges.

PubMed

Clausen, Ingelin; Glott, Thomas

2014-09-22

This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians.  Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.

How should doctors disclose conflicts of interest to patients? A focus group investigation.

PubMed

Oakes, J Michael; Whitham, Hilary K; Spaulding, Alicen Burns; Zentner, Lynn A; Beccard, Seth R

2015-01-01

Disclosure is often proposed as a strategy for handling financial conflicts of interest in medicine. Yet there has been no guidance on how clinicians should disclose potential conflicts of interest to patients. To discern patients' attitudes toward conflicts of interest in medicine and their opinions about how physicians should disclose possible conflicts in the clinical setting, we conducted six focus groups with patients recruited from three clinics in the Twin Cities area. Investigators reviewed audio recordings of the focus group discussions independently and identified themes. Maintaining patient-doctor trust was critical to all study participants. Most wanted to know only about conflicts of interest that were directly relevant to their care. In addition, most participants said physicians and other health care providers should offer patients an easy-to-read document about any conflict of interest during clinic check-ins and bring up the subject when discussing specific treatment plans for which the conflict of interest is relevant. Our study offers the first insights into patient attitudes toward and opinions about disclosure practices in clinical settings. More research into the practical aspects of managing conflicts of interest is needed as ineffective disclosure may undermine patients' trust in their doctors.

Representing nursing assessments in clinical information systems using the logical observation identifiers, names, and codes database.

PubMed

Matney, Susan; Bakken, Suzanne; Huff, Stanley M

2003-01-01

In recent years, the Logical Observation Identifiers, Names, and Codes (LOINC) Database has been expanded to include assessment items of relevance to nursing and in 2002 met the criteria for "recognition" by the American Nurses Association. Assessment measures in LOINC include those related to vital signs, obstetric measurements, clinical assessment scales, assessments from standardized nursing terminologies, and research instruments. In order for LOINC to be of greater use in implementing information systems that support nursing practice, additional content is needed. Moreover, those implementing systems for nursing practice must be aware of the manner in which LOINC codes for assessments can be appropriately linked with other aspects of the nursing process such as diagnoses and interventions. Such linkages are necessary to document nursing contributions to healthcare outcomes within the context of a multidisciplinary care environment and to facilitate building of nursing knowledge from clinical practice. The purposes of this paper are to provide an overview of the LOINC database, to describe examples of assessments of relevance to nursing contained in LOINC, and to illustrate linkages of LOINC assessments with other nursing concepts.

Urinary urgency - translating the evidence base into daily clinical practice.

PubMed

Cardozo, L; Chapple, C R; Dmochowski, R; Fitzgerald, M P; Hanno, P; Michel, M C; Staskin, D; Van Kerrebroeck, P; Wyndaele, J-J; Yamaguchi, O; Yoshida, M

2009-12-01

To consider the currently available knowledge and understanding of the symptom of urgency. Each faculty member reviewed the literature base of a different aspect of urgency and along with their personal clinical experience provided a base of evidence for discussion. This overview summarises relevant published literature and the current clinical experience of the authors. Whilst the mechanisms producing the sensation of urgency are still not fully understood and we are working within a definition that may complicate measurement and treatment, our pressing need is to effectively manage our patients for whom the practical nature of urgency can be all too apparent. Health care professionals have an important role to play today in helping to alleviate the widespread problem of urgency and its consequences.

Swallowing in Parkinson's disease: clinical issues and management.

PubMed

Miller, Nick

2017-06-01

Changes to swallowing affect most people with Parkinson's disease (PD). Changes may not initially exercise a decisive impact, but can later pose significant threats to nutritional, hydration and respiratory health and psychosocial quality of life. This review, from a largely clinical viewpoint, outlines the nature of changes in PD and considers the issue of how many people are affected and in what ways. It outlines main approaches to assessment and management, with an emphasis on aspects relevant to PD. Dysphagia contributes to drooling in PD. The review therefore also touches on the nature and management of this condition that has its own set of health and psychosocial quality-of-life issues.

Schizophrenia, narrative, and neurocognition: The utility of life-stories in understanding social problem-solving skills.

PubMed

Moe, Aubrey M; Breitborde, Nicholas J K; Bourassa, Kyle J; Gallagher, Colin J; Shakeel, Mohammed K; Docherty, Nancy M

2018-06-01

Schizophrenia researchers have focused on phenomenological aspects of the disorder to better understand its underlying nature. In particular, development of personal narratives-that is, the complexity with which people form, organize, and articulate their "life stories"-has recently been investigated in individuals with schizophrenia. However, less is known about how aspects of narrative relate to indicators of neurocognitive and social functioning. The objective of the present study was to investigate the association of linguistic complexity of life-story narratives to measures of cognitive and social problem-solving abilities among people with schizophrenia. Thirty-two individuals with a diagnosis of schizophrenia completed a research battery consisting of clinical interviews, a life-story narrative, neurocognitive testing, and a measure assessing multiple aspects of social problem solving. Narrative interviews were assessed for linguistic complexity using computerized technology. The results indicate differential relationships of linguistic complexity and neurocognition to domains of social problem-solving skills. More specifically, although neurocognition predicted how well one could both describe and enact a solution to a social problem, linguistic complexity alone was associated with accurately recognizing that a social problem had occurred. In addition, linguistic complexity appears to be a cognitive factor that is discernible from other broader measures of neurocognition. Linguistic complexity may be more relevant in understanding earlier steps of the social problem-solving process than more traditional, broad measures of cognition, and thus is relevant in conceptualizing treatment targets. These findings also support the relevance of developing narrative-focused psychotherapies. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The Cross-National Relevance of U.S. Formulated Theories of College Student Departure

ERIC Educational Resources Information Center

Braxton, John M.

2013-01-01

This article focuses on the cross-national relevance of theories of college student departure formulated by U.S. scholars. Some aspects of U.S. developed theories of college student departure hold some semblance of cross-national relevance. Economic and sociological perspectives provide such aspects. The weighing of costs and benefits inherent in…

Evaluating walking in patients with multiple sclerosis: which assessment tools are useful in clinical practice?

PubMed

Bethoux, Francois; Bennett, Susan

2011-01-01

Walking limitations are among the most visible manifestations of multiple sclerosis (MS). Regular walking assessments should be a component of patient management and require instruments that are appropriate from the clinician's and the patient's perspectives. This article reviews frequently used instruments to assess walking in patients with MS, with emphasis on their validity, reliability, and practicality in the clinical setting. Relevant articles were identified based on PubMed searches using the following terms: "multiple sclerosis AND (walking OR gait OR mobility OR physical activity) AND (disability evaluation)"; references of relevant articles were also searched. Although many clinician- and patient-driven instruments are available, not all have been validated in MS, and some are not sensitive enough to detect small but clinically important changes. Choosing among these depends on what needs to be measured, psychometric properties, the clinical relevance of results, and practicality with respect to space, time, and patient burden. Of the instruments available, the clinician-observed Timed 25-Foot Walk and patient self-report 12-Item Multiple Sclerosis Walking Scale have properties that make them suitable for routine evaluation of walking performance. The Dynamic Gait Index and the Timed Up and Go test involve other aspects of mobility, including balance. Tests of endurance, such as the 2- or 6-Minute Walk, may provide information on motor fatigue not captured by other tests. Quantitative measurement of gait kinetics and kinematics, and recordings of mobility in the patient's environment via accelerometry or Global Positioning System odometry, are currently not routinely used in the clinical setting.

Assessment of clinical co-morbidities

PubMed Central

Basu, Debasish; Basu, Aniruddha; Ghosh, Abhishek

2018-01-01

A large proportion of patients with substance use disorders have clinical comorbidities, either medical or psychiatric. An initial assessment is necessary initially for prompt identification and management of any psychiatric or medical emergency, and thereafter a more detailed assessment for the comprehensive understanding of the individual. This should be done keeping in mind the goals of both immediate and long term assessment so that a comprehensive but individualized, context and culture sensitive, reality based, recovery-oriented management plan can be formulated. Assessment should consist of not only history-taking, physical and mental status examination but also laboratory and instrument based assessment as needed. During assessment, collateral reports and past medical records are valuable additions along with self-report. Since substance use disorders influence various aspects of daily life, hence medical, social, occupational, religious, spiritual, financial and legal aspects should be evaluated. Overall, the assessment needs to be diagnosis and management focused, covering the various bio-psycho-social domains relevant to the individual. PMID:29540914

[Disease versus disorder. Medical and socio-environmental aspects of mental suffering].

PubMed

Heinz, A

2015-01-01

A disease concept should be broad enough to provide social protection for all subjects suffering from this malady but at the same time it needs to be narrow enough to avoid pathologization of behavior that is merely socially undesirable. From a medical perspective a"disease" is present if functions are impaired that are relevant for individual survival. In the field of psychiatry and psychotherapy, such medically relevant functions include the ability to be alert and fully oriented, to ascribe one's own intentions to oneself and to modulate affects according to the situation. Beyond such medically relevant symptoms of a disease, any clinically relevant dysfunction should also be harmful for the individual if a mental malady is to be diagnosed. One such harmful consequence of a disease can be that the person feels ill and suffers from this state, another negative consequence for the individual can be due to an impairment of activities of daily living and social participation. These harmful consequences of a disease are usually discussed under the heading of the"illness experience" and the"sickness aspect" of any disorder. Beyond mental maladies characterized by disease symptoms that are accompanied either by an illness experience or impaired activities of daily living and social participation (sickness), there are many states of human suffering which can be objectified and classified but do not constitute a disease in the medical sense and should more aptly be named a disorder.

IgA and IgG1 reactivities assessed by flow cytometry mirror clinical aspects of infants with ocular congenital toxoplasmosis.

PubMed

de Jesus, Laura Néspoli Nassar Pansini; Tonini, Aline de Castro Zacche; Barros, Geisa Baptista; Coelho-dos-Reis, Jordana Grazziela A; Béla, Samantha Ribeiro; Antonelli, Lis Ribeiro do Valle; Machado, Anderson Silva; Carneiro, Ana Carolina Aguiar Vasconcelos; Andrade, Gláucia Manzan Queiroz; Vasconcelos-Santos, Daniel Vitor; Januário, José Nélio; Teixeira-Carvalho, Andréa; Vitor, Ricardo Wagner Almeida; Ferro, Eloísa A V; Mineo, José Roberto; Bahia-Oliveira, Lilian Maria Garcia; Martins-Filho, Olindo Assis; Lemos, Elenice Moreira

2016-01-01

This study intended to apply the flow cytometric analysis of IgA and IgG reactivity and intracytoplasmic cytokine analysis to understand and decode the clinical aspects of infants with ocular congenital toxoplasmosis. The Toxoplasma gondii-infected infants (TOXO) were subdivided according to their clinical aspects based on the absence (NRL), presence of active (ARL), active/cicatricial (ACRL) or cicatricial retinochoroidal lesions (CRL) and compared to non-infected controls (NI). The reactivity of anti-T. gondii IgG subclasses resembles the clinical aspects of ocular lesions. IgG and IgG1 discriminate infants with cicatricial lesions (ACRL and CRL) from both ARL and NLR. IgG2 and IgG3 are particularly higher in ACRL and CRL as compared to NLR. No differences were observed when IgG4 reactivity was evaluated. Thus, the results indicated that the reactivity patterns of IgA, IgG and IgG subclasses are able to discriminate ARL, ACRL and CRL from NLR or NI. IgA and IgG subclasses are relevant serological biomarkers with diagnostic and prognostic applicability, respectively. Moreover, IgA and IgG1 were closely related to cytokine production by innate/adaptive immunity cells. IgA reactivity was directly associated to TNF-α-derived from neutrophils, monocytes and CD8(+) T-cells, while IgG1 was inversely correlated with IFN-γ-producing CD4(+) and CD8(+) T-cells but positively correlated with IL-10(+) B-cells. These findings provide insights on the relationship between the cytokine production by innate/adaptive immunity and the antibody pattern of infants with ocular congenital toxoplasmosis. In addition, the present study supports the use of flow cytometric serology as a potential tool for the diagnosis and monitoring of ocular lesions in T. gondii-infected infants in the clinical setting. Copyright © 2015 Elsevier B.V. All rights reserved.

Computer assisted learning (CAL) of oral manifestations of HIV disease.

PubMed

Porter, S R; Telford, A; Chandler, K; Furber, S; Williams, J; Price, S; Scully, C; Triantos, D; Bain, L

1996-09-07

General dental practitioners (GDPs) in the UK may wish additional education on relevant aspects of human immunodeficiency virus (HIV) disease. The aim of the present study was to develop and assess a computer assisted learning package on the oral manifestations of HIV disease of relevance to GDPs. A package was developed using a commercially-available software development tool and assessed by a group of 75 GDPs interested in education and computers. Fifty-four (72%) of the GDPs completed a self-administered questionnaire of their opinions of the package. The majority reported the package to be easy to load and run, that it provided clear instructions and displays, and that it was a more effective educational tool than videotapes, audiotapes, professional journals and textbooks, and of similar benefit as post-graduate courses. The GDPs often commented favourably on the effectiveness of the clinical images and use of questions and answers, although some had criticisms of these and other aspects of the package. As a consequence of this investigation the package has been modified and distributed to GDPs in England and Wales.

The role of social media in clinical excellence.

PubMed

Batt-Rawden, Samantha; Flickinger, Tabor; Weiner, John; Cheston, Christine; Chisolm, Margaret

2014-07-01

The provision of excellent patient care is a goal shared by all doctors. The role of social media (SM) in helping medical students and doctors achieve clinical excellence is unknown. Social media may help facilitate the achievement of clinical excellence This report aimed to identify examples of how SM may be used to help promote the achievement of clinical excellence in medical learners. Three of the authors previously conducted a systematic review of the published literature on SM use in undergraduate, graduate and continuing medical education. Two authors re-examined the 14 evaluative studies to identify any examples of SM use that may facilitate the achievement of clinical excellence and to consider whether there were any aspects of clinical excellence for which no studies had been performed, and, if so, whether SM was relevant to these domains. Each study touched on one or more of the following domains of clinical excellence: communication and interpersonal skills; professionalism and humanism; knowledge; diagnostic acumen; exhibiting a passion for patient care; a scholarly approach to clinical practice; and explicitly modelling expertise to medical trainees. No study addressed the role of SM to promote the skillful negotiation of the health care system, and in collaboration with investigators to advance science and discovery; however, additional evidence suggested that SM may play an adjunctive role in promoting the achievement of these aspects of clinical excellence. This report supports the hypothesis that SM may help facilitate the achievement of clinical excellence; however, further research is needed into the role of SM in promoting the achievement of clinical excellence. © 2014 John Wiley & Sons Ltd.

Training interpretation biases among individuals with body dysmorphic disorder symptoms.

PubMed

Premo, Julie E; Sarfan, Laurel D; Clerkin, Elise M

2016-03-01

The current study provided an initial test of a Cognitive Bias Modification for Interpretations (CBM-I) training paradigm among a sample with elevated BDD symptoms (N=86). As expected, BDD-relevant interpretations were reduced among participants who completed a positive (vs. comparison) training program. Results also pointed to the intriguing possibility that modifying biased appearance-relevant interpretations is causally related to changes in biased, socially relevant interpretations. Further, providing support for cognitive behavioral models, residual change in interpretations was associated with some aspects of in vivo stressor responding. However, contrary to expectations there were no significant effects of condition on emotional vulnerability to a BDD stressor, potentially because participants in both training conditions experienced reductions in biased socially-threatening interpretations following training (suggesting that the "comparison" condition was not inert). These findings have meaningful theoretical and clinical implications, and fit with transdiagnostic conceptualizations of psychopathology. Copyright © 2015 Elsevier Ltd. All rights reserved.

Health Literacy and Atrial Fibrillation: Relevance and Future Directions for Patient-centred Care.

PubMed

Aronis, Konstantinos N; Edgar, Brittany; Lin, Wendy; Martins, Maria Auxiliadora Parreiras; Paasche-Orlow, Michael K; Magnani, Jared W

2017-01-01

Atrial fibrillation (AF) is a common cardiac arrhythmia with significant clinical outcomes, and is associated with high medical and social costs. AF is complicated for patients because of its specialised terminology, long-term adherence, symptom monitoring, referral to specialty care, array of potential interventions and potential for adversity. Health literacy is a frequently under-recognised, yet fundamental, component towards successful care in AF. Health literacy is defined as the capacity to obtain, process and understand health information, and has had markedly limited study in AF. However, health literacy could contribute to how patients interpret symptoms, navigate care, and participate in treatment evaluation and decision-making. This review aims to summarise the clinical importance and essential relevance of health literacy in AF. We focus here on central aspects of AF care that are most related to self-care, including understanding the symptoms of AF, shared decision-making, adherence and anticoagulation for stroke prevention. We discuss opportunities to enhance AF care based on findings from the literature on health literacy, and identify important gaps. Our overall objective is to articulate the importance and relevance of integrating health literacy in the care of individuals with AF.

Bruton's Tyrosine Kinase: From X-Linked Agammaglobulinemia Toward Targeted Therapy for B-Cell Malignancies

PubMed Central

Ponader, Sabine; Burger, Jan A.

2014-01-01

Discovery of Bruton's tyrosine kinase (BTK) mutations as the cause for X-linked agammaglobulinemia was a milestone in understanding the genetic basis of primary immunodeficiencies. Since then, studies have highlighted the critical role of this enzyme in B-cell development and function, and particularly in B-cell receptor signaling. Because its deletion affects mostly B cells, BTK has become an attractive therapeutic target in autoimmune disorders and B-cell malignancies. Ibrutinib (PCI-32765) is the most advanced BTK inhibitor in clinical testing, with ongoing phase III clinical trials in patients with chronic lymphocytic leukemia and mantle-cell lymphoma. In this article, we discuss key discoveries related to BTK and clinically relevant aspects of BTK inhibitors, and we provide an outlook into clinical development and open questions regarding BTK inhibitor therapy. PMID:24778403

The polycystic ovary syndrome: a position statement from the European Society of Endocrinology.

PubMed

Conway, Gerard; Dewailly, Didier; Diamanti-Kandarakis, Evanthia; Escobar-Morreale, Héctor F; Franks, Stephen; Gambineri, Alessandra; Kelestimur, Fahrettin; Macut, Djuro; Micic, Dragan; Pasquali, Renato; Pfeifer, Marija; Pignatelli, Duarte; Pugeat, Michel; Yildiz, Bulent O

2014-10-01

Polycystic ovary syndrome (PCOS) is the most common ovarian disorder associated with androgen excess in women, which justifies the growing interest of endocrinologists. Great efforts have been made in the last 2 decades to define the syndrome. The presence of three different definitions for the diagnosis of PCOS reflects the phenotypic heterogeneity of the syndrome. Major criteria are required for the diagnosis, which in turn identifies different phenotypes according to the combination of different criteria. In addition, the relevant impact of metabolic issues, specifically insulin resistance and obesity, on the pathogenesis of PCOS, and the susceptibility to develop earlier than expected glucose intolerance states, including type 2 diabetes, has supported the notion that these aspects should be considered when defining the PCOS phenotype and planning potential therapeutic strategies in an affected subject. This paper offers a critical endocrine and European perspective on the debate on the definition of PCOS and summarises all major aspects related to aetiological factors, including early life events, potentially involved in the development of the disorder. Diagnostic tools of PCOS are also discussed, with emphasis on the laboratory evaluation of androgens and other potential biomarkers of ovarian and metabolic dysfunctions. We have also paid specific attention to the role of obesity, sleep disorders and neuropsychological aspects of PCOS and on the relevant pathogenetic aspects of cardiovascular risk factors. In addition, we have discussed how to target treatment choices based according to the phenotype and individual patient's needs. Finally, we have suggested potential areas of translational and clinical research for the future with specific emphasis on hormonal and metabolic aspects of PCOS. © 2014 European Society of Endocrinology.

Additive Manufacturing: A Novel Method for Fabricating Cobalt-Chromium Removable Partial Denture Frameworks.

PubMed

Alifui-Segbaya, Frank; Williams, Robert John; George, Roy

2017-06-01

Additive manufacturing (AM) often referred to as 3D printing (3DP) has shown promise of being significantly viable in the construction of cobalt-chromium removable partial denture (RPD) frameworks. The current paper seeks to discuss AM technologies (photopolymerization processes and selective laser melting) and review their scope. The review also discusses the clinical relevance of cobalt-chromium RPD frameworks. All relevant publications in English over the last 10 years, when the first 3D-printed RPD framework was reported, are examined. The review notes that AM offers significant benefits in terms of speed of the manufacturing processes however cost and other aspects of current technologies remain a hindrance. Copyright© 2017 Dennis Barber Ltd.

The Care Dialog: the "ethics of care" approach and its importance for clinical ethics consultation.

PubMed

Schuchter, Patrick; Heller, Andreas

2018-03-01

Ethics consultation in institutions of the healthcare system has been given a standard form based on three pillars: education, the development of guidelines and concrete ethics consultation in case conferences. The spread of ethics committees, which perform these tasks on an organizational level, is a remarkable historic achievement. At the same time it cannot be denied that modern ethics consultation neglects relevant aspects of care ethics approaches. In our essay we present an "ethics of care" approach as well as an empirical pilot project-"Ethics from the bottom up"-which organizes ethics consultation based on this focus. Findings and philosophy of the project will be discussed as far as relevant for ethics consultation in the healthcare system.

The Chemically Elegant Proton Pump Inhibitors

PubMed Central

Roche, Victoria F.

2006-01-01

Medicinal chemistry instruction at Creighton University is designed to provide an in-depth scientifically grounded and clinically relevant learning experience for pharmacy students. Each topic covered in the 2-semester required course sequence is selected based on the general utility of the compounds in question and/or the therapeutic importance of the drugs in treating life-threatening diseases. All lessons provided to campus- and Web-based students by the author are in the form of a descriptive and conversational narrative and course requirements are in place to assure that students read the lesson prior to the class period in which it is discussed. Learning tools and aids are provided to help students more readily discern the most critical aspects of each lesson, to practice required critical thinking and structure analysis skills, and to self-assess competency in meeting specific learning objectives. This manuscript illustrates this approach by sharing a lesson on the chemistry and clinically relevant structure-activity relationships of proton pump inhibitors. PMID:17149430

Legal and ethical issues in research

PubMed Central

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-01-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees. PMID:27729698

Management Approaches for Enterocutaneous Fistulas.

PubMed

Heimroth, Jamie; Chen, Eric; Sutton, Erica

2018-03-01

There are very few clinical studies that highlight a definitive and comprehensive guideline for the management of enterocutaneous fistulas. Most accepted guidelines are found in textbooks and are taken from expert advice and case reports. The goal of this review is to highlight advancements relevant to the management of enterocutaneous fistulas from the recent two to three years. Although strong evidence-based guidelines are lacking, the consensus is that a multidisciplinary team working with a clear treatment plan targeting multiple aspects of management can maximize patient outcomes.

Psychiatry and the 'Gay Holocaust' - the lessons of Jill Soloway's Transparent.

PubMed

Robertson, Michael D; Light, Edwina; Walter, Garry; Lipworth, Wendy

2016-12-01

We aim to consider issues relevant to psychiatry raised by the television series, Transparent. Psychiatry's disturbing history regarding the lesbian, gay, bisexual, transgender and intersex (LGBTI) community shares many aspects with the group's persecution by the National Socialist regime in Germany. The medicalised 'otherness' conferred on LGBTI patients, latent homophobia and transphobia, and lack of culturally sensitive clinical services for these people represent a major ethical challenge for modern Australasian psychiatry. © The Royal Australian and New Zealand College of Psychiatrists 2016.

Teaching strategies for assessing and managing urinary incontinence in older adults.

PubMed

Bradway, Christine; Cacchione, Pamela

2010-07-01

Urinary incontinence is common and affects many aspects of older adults' lives; therefore, it is essential that nursing faculty include this content in classroom and clinical teaching situations. This article describes innovative strategies for teaching upper-level nursing students (e.g., junior and senior undergraduates) about urinary incontinence in older adults, specifically, the relevant anatomy and physiology of continence and associated pathophysiology of urinary incontinence, risk factors and consequences, definitions and types, and effective nursing assessment and management strategies. Copyright 2010, SLACK Incorporated.

Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome.

PubMed

de Toro-Martín, Juan; Arsenault, Benoit J; Després, Jean-Pierre; Vohl, Marie-Claude

2017-08-22

The translation of the growing increase of findings emerging from basic nutritional science into meaningful and clinically relevant dietary advices represents nowadays one of the main challenges of clinical nutrition. From nutrigenomics to deep phenotyping, many factors need to be taken into account in designing personalized and unbiased nutritional solutions for individuals or population sub-groups. Likewise, a concerted effort among basic, clinical scientists and health professionals will be needed to establish a comprehensive framework allowing the implementation of these new findings at the population level. In a world characterized by an overwhelming increase in the prevalence of obesity and associated metabolic disturbances, such as type 2 diabetes and cardiovascular diseases, tailored nutrition prescription represents a promising approach for both the prevention and management of metabolic syndrome. This review aims to discuss recent works in the field of precision nutrition analyzing most relevant aspects affecting an individual response to lifestyle/nutritional interventions. Latest advances in the analysis and monitoring of dietary habits, food behaviors, physical activity/exercise and deep phenotyping will be discussed, as well as the relevance of novel applications of nutrigenomics, metabolomics and microbiota profiling. Recent findings in the development of precision nutrition are highlighted. Finally, results from published studies providing examples of new avenues to successfully implement innovative precision nutrition approaches will be reviewed.

Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome

PubMed Central

de Toro-Martín, Juan; Arsenault, Benoit J.; Després, Jean-Pierre

2017-01-01

The translation of the growing increase of findings emerging from basic nutritional science into meaningful and clinically relevant dietary advices represents nowadays one of the main challenges of clinical nutrition. From nutrigenomics to deep phenotyping, many factors need to be taken into account in designing personalized and unbiased nutritional solutions for individuals or population sub-groups. Likewise, a concerted effort among basic, clinical scientists and health professionals will be needed to establish a comprehensive framework allowing the implementation of these new findings at the population level. In a world characterized by an overwhelming increase in the prevalence of obesity and associated metabolic disturbances, such as type 2 diabetes and cardiovascular diseases, tailored nutrition prescription represents a promising approach for both the prevention and management of metabolic syndrome. This review aims to discuss recent works in the field of precision nutrition analyzing most relevant aspects affecting an individual response to lifestyle/nutritional interventions. Latest advances in the analysis and monitoring of dietary habits, food behaviors, physical activity/exercise and deep phenotyping will be discussed, as well as the relevance of novel applications of nutrigenomics, metabolomics and microbiota profiling. Recent findings in the development of precision nutrition are highlighted. Finally, results from published studies providing examples of new avenues to successfully implement innovative precision nutrition approaches will be reviewed. PMID:28829397

What do evidence-based secondary journals tell us about the publication of clinically important articles in primary healthcare journals?

PubMed Central

McKibbon, Kathleen Ann; Wilczynski, Nancy L; Haynes, Robert Brian

2004-01-01

Background We conducted this analysis to determine i) which journals publish high-quality, clinically relevant studies in internal medicine, general/family practice, general practice nursing, and mental health; and ii) the proportion of clinically relevant articles in each journal. Methods We performed an analytic survey of a hand search of 170 general medicine, general healthcare, and specialty journals for 2000. Research staff assessed individual articles by using explicit criteria for scientific merit for healthcare application. Practitioners assessed the clinical importance of these articles. Outcome measures were the number of high-quality, clinically relevant studies published in the 170 journal titles and how many of these were published in each of four discipline-specific, secondary "evidence-based" journals (ACP Journal Club for internal medicine and its subspecialties; Evidence-Based Medicine for general/family practice; Evidence-Based Nursing for general practice nursing; and Evidence-Based Mental Health for all aspects of mental health). Original studies and review articles were classified for purpose: therapy and prevention, screening and diagnosis, prognosis, etiology and harm, economics and cost, clinical prediction guides, and qualitative studies. Results We evaluated 60,352 articles from 170 journal titles. The pass criteria of high-quality methods and clinically relevant material were met by 3059 original articles and 1073 review articles. For ACP Journal Club (internal medicine), four titles supplied 56.5% of the articles and 27 titles supplied the other 43.5%. For Evidence-Based Medicine (general/family practice), five titles supplied 50.7% of the articles and 40 titles supplied the remaining 49.3%. For Evidence-Based Nursing (general practice nursing), seven titles supplied 51.0% of the articles and 34 additional titles supplied 49.0%. For Evidence-Based Mental Health (mental health), nine titles supplied 53.2% of the articles and 34 additional titles supplied 46.8%. For the disciplines of internal medicine, general/family practice, and mental health (but not general practice nursing), the number of clinically important articles was correlated withScience Citation Index (SCI) Impact Factors. Conclusions Although many clinical journals publish high-quality, clinically relevant and important original studies and systematic reviews, the articles for each discipline studied were concentrated in a small subset of journals. This subset varied according to healthcare discipline; however, many of the important articles for all disciplines in this study were published in broad-based healthcare journals rather than subspecialty or discipline-specific journals. PMID:15350200

Pulmonary atelectasis in newborns with clinically treatable diseases who are on mechanical ventilation: clinical and radiological aspects

PubMed Central

Dominguez, Mariana Chiaradia; Alvares, Beatriz Regina

2018-01-01

Objective To analyze the radiological aspects of pulmonary atelectasis in newborns on mechanical ventilation and treated in an intensive care unit, associating the characteristics of atelectasis with the positioning of the head and endotracheal tube seen on the chest X-ray, as well as with the clinical variables. Materials and Methods This was a retrospective cross-sectional study of 60 newborns treated between 1985 and 2015. Data were collected from medical records and radiology reports. To identify associations between variables, we used Fisher's exact test. The level of significance was set at p < 0.05. Results The clinical characteristics associated with improper positioning of the endotracheal tube were prematurity and a birth weight of less than 1000 g. Among the newborns evaluated, the most common comorbidity was hyaline membrane disease. Atelectasis was seen most frequently in the right upper lobe, although cases of total atelectasis were more common in the left lung. Malpositioning of the head showed a trend toward an association with atelectasis in the left upper lobe. Conclusion Pulmonary atelectasis is a common complication in newborns on mechanical ventilation. Radiological evaluation of the endotracheal tube placement provides relevant information for the early correction of this condition. PMID:29559762

Reshaping clinical science: Introduction to the Special Issue on Psychophysiology and the NIMH Research Domain Criteria (RDoC) initiative.

PubMed

Patrick, Christopher J; Hajcak, Greg

2016-03-01

The National Institute of Mental Health's (NIMH) Research Domain Criteria (RDoC) initiative seeks to establish new dimensional conceptions of mental health problems, through the investigation of clinically relevant "process" constructs that have neurobiological as well as psychological referents. This special issue provides a detailed overview of the RDoC framework by NIMH officials Michael Kozak and Bruce Cuthbert, and spotlights RDoC-oriented investigative efforts by leading psychophysiological research groups as examples of how clinical science might be reshaped through application of RDoC principles. Accompanying commentaries highlight key aspects of the work by each group, and discuss reported methods/findings in relation to promises and challenges of the RDoC initiative more broadly. © 2016 Society for Psychophysiological Research.

Clinical relevance of changes in bone metabolism in inflammatory bowel disease

PubMed Central

Miheller, Pal; Lőrinczy, Katalin; Lakatos, Peter Laszlo

2010-01-01

Low bone mineral density is an established, frequent, but often neglected complication in patients with inflammatory bowel disease (IBD). Data regarding the diagnosis, therapy and follow-up of low bone mass in IBD has been partially extrapolated from postmenopausal osteoporosis; however, the pathophysiology of bone loss is altered in young patients with IBD. Fracture, a disabling complication, is the most important clinical outcome of low bone mass. Estimation of fracture risk in IBD is difficult. Numerous risk factors have to be considered, and these factors should be weighed properly to help in the identification of the appropriate patients for screening. In this editorial, the authors aim to highlight the most important clinical aspects of the epidemiology, prevention, diagnosis and treatment of IBD-related bone loss. PMID:21105186

Electron microscopy of human peripheral nerves of clinical relevance to the practice of nerve blocks. A structural and ultrastructural review based on original experimental and laboratory data.

PubMed

Reina, M A; Arriazu, R; Collier, C B; Sala-Blanch, X; Izquierdo, L; de Andrés, J

2013-12-01

The goal is to describe the ultrastructure of normal human peripheral nerves, and to highlight key aspects that are relevant to the practice of peripheral nerve block anaesthesia. Using samples of sciatic nerve obtained from patients, and dural sac, nerve root cuff and brachial plexus dissected from fresh human cadavers, an analysis of the structure of peripheral nerve axons and distribution of fascicles and topographic composition of the layers that cover the nerve is presented. Myelinated and unmyelinated axons, fascicles, epineurium, perineurium and endoneurium obtained from patients and fresh cadavers were studied by light microscopy using immunohistochemical techniques, and transmission and scanning electron microscopy. Structure of perineurium and intrafascicular capillaries, and its implications in blood-nerve barrier were revised. Each of the anatomical elements is analyzed individually with regard to its relevance to clinical practice to regional anaesthesia. Routine practice of regional anaesthetic techniques and ultrasound identification of nerve structures has led to conceptions, which repercussions may be relevant in future applications of these techniques. In this regard, the ultrastructural and histological perspective accomplished through findings of this study aims at enlightening arising questions within the field of regional anaesthesia. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

Presentaciones poco comunes y peligros de la sífilis secundaria: periosteitis, tenosinovitis y anomalías hepáticas.

PubMed

Rosa-Gonçalves, Diana; Bernardes, Miguel; Costa, Lúcia

2017-06-02

We herein describe two cases of secondary syphilis in patients with human immunodeficiency virus (HIV) infection with an unusual presentation, a diffuse polyostotic periosteitis. Patients referred mainly intense bone pain. Other relevant aspects of the clinical pictures were flexor tenosynovitis and hepatic abnormalities. Given the persistence of symptoms, the treatment duration performed was different from most described in literature. However, although more slowly than expected, both obtained a favorable clinical response after treatment with benzathine penicillin G. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

[Molecular techniques in mycology].

PubMed

Rodríguez-Tudela, Juan Luis; Cuesta, Isabel; Gómez-López, Alicia; Alastruey-Izquierdo, Ana; Bernal-Martínez, Leticia; Cuenca-Estrella, Manuel

2008-11-01

An increasing number of molecular techniques for the diagnosis of fungal infections have been developed in the last few years, due to the growing prevalence of mycoses and the length of time required for diagnosis when classical microbiological methods are used. These methods are designed to resolve the following aspects of mycological diagnosis: a) Identification of fungi to species level by means of sequencing relevant taxonomic targets; b) early clinical diagnosis of invasive fungal infections; c) detection of molecular mechanisms of resistance to antifungal agents; and d) molecular typing of fungi. Currently, these methods are restricted to highly developed laboratories. However, some of these techniques will probably be available in daily clinical practice in the near future.

A preclinical Talbot-Lau prototype for x-ray dark-field imaging of human-sized objects.

PubMed

Hauke, C; Bartl, P; Leghissa, M; Ritschl, L; Sutter, S M; Weber, T; Zeidler, J; Freudenberger, J; Mertelmeier, T; Radicke, M; Michel, T; Anton, G; Meinel, F G; Baehr, A; Auweter, S; Bondesson, D; Gaass, T; Dinkel, J; Reiser, M; Hellbach, K

2018-06-01

Talbot-Lau x-ray interferometry provides information about the scattering and refractive properties of an object - in addition to the object's attenuation features. Until recently, this method was ineligible for imaging human-sized objects as it is challenging to adapt Talbot-Lau interferometers (TLIs) to the relevant x-ray energy ranges. In this work, we present a preclinical Talbot-Lau prototype capable of imaging human-sized objects with proper image quality at clinically acceptable dose levels. The TLI is designed to match a setup of clinical relevance as closely as possible. The system provides a scan range of 120 × 30 cm 2 by using a scanning beam geometry. Its ultimate load is 100 kg. High aspect ratios and fine grid periods of the gratings ensure a reasonable setup length and clinically relevant image quality. The system is installed in a university hospital and is, therefore, exposed to the external influences of a clinical environment. To demonstrate the system's capabilities, a full-body scan of a euthanized pig was performed. In addition, freshly excised porcine lungs with an extrinsically provoked pneumothorax were mounted into a human thorax phantom and examined with the prototype. Both examination sequences resulted in clinically relevant image quality - even in the case of a skin entrance air kerma of only 0.3 mGy which is in the range of human thoracic imaging. The presented case of a pneumothorax and a reader study showed that the prototype's dark-field images provide added value for pulmonary diagnosis. We demonstrated that a dedicated design of a Talbot-Lau interferometer can be applied to medical imaging by constructing a preclinical Talbot-Lau prototype. We experienced that the system is feasible for imaging human-sized objects and the phase-stepping approach is suitable for clinical practice. Hence, we conclude that Talbot-Lau x-ray imaging has potential for clinical use and enhances the diagnostic power of medical x-ray imaging. © 2018 American Association of Physicists in Medicine.

HOSPITAL MANAGERS' NEED FOR INFORMATION ON HEALTH TECHNOLOGY INVESTMENTS.

PubMed

Ølholm, Anne Mette; Kidholm, Kristian; Birk-Olsen, Mette; Christensen, Janne Buck

2015-01-01

There is growing interest in implementing hospital-based health technology assessment (HB-HTA) as a tool to facilitate decision making based on a systematic and multidisciplinary assessment of evidence. However, the decision-making process, including the informational needs of hospital decision makers, is not well described. The objective was to review empirical studies analysing the information that hospital decision makers need when deciding about health technology (HT) investments. A systematic review of empirical studies published in English or Danish from 2000 to 2012 was carried out. The literature was assessed by two reviewers working independently. The identified informational needs were assessed with regard to their agreement with the nine domains of EUnetHTA's Core Model. A total of 2,689 articles were identified and assessed. The review process resulted in 14 relevant studies containing 74 types of information that hospital decision makers found relevant. In addition to information covered by the Core Model, other types of information dealing with political and strategic aspects were identified. The most frequently mentioned types of information in the literature related to clinical, economic and political/strategic aspects. Legal, social, and ethical aspects were seldom considered most important. Hospital decision makers are able to describe their information needs when deciding on HT investments. The different types of information were not of equal importance to hospital decision makers, however, and full agreement between EUnetHTA's Core Model and the hospital decision-makers' informational needs was not observed. They also need information on political and strategic aspects not covered by the Core Model.

[Clinical studies in peripheral arterial occlusive disease: update from the aspects of a meta-narrative review].

PubMed

Melzer, Jörg; Saller, Reinhard

2013-01-01

Atherosclerosis is a systemic disease. Its association with the metabolic syndrome requires a multimodal therapy setting, to alleviate symptoms and for primary and secondary prevention. In the planning of the therapy, information about evidence of the interventions and a rationale for reasonable combinations are important. For compiling a meta-narrative review (MNR) on the evidence of complementary and conventional pharmaco-therapy in peripheral arterial occlusive disease (PAOD), the literature was searched for meta-analyses of randomized controlled trials (RCTs). These were evaluated taking into account network-pharmacological aspects and research parameters. 4 suitable meta-analyses were found. In comparison to placebo, treatments with verum showed a significant improvement of the maximum walking distance of 63.5 m (95% confidence interval (CI) 27.11-99.91 m; Padma 28, Tibetan Formula), 41.3 m (95% CI -7.1-89.7 m; cilostazol, phosphodiesterase IIl inhibitor), 43.8 m (95% CI 14.1-73.6 m; pentoxifylline, rheological drug), and 71.2 m (95% CI 13.3-129.0 m; naftidrofuryl, rheological drug). Only for Padma 28, clinical relevance, defined as an increase of the maximum walking distance by >100 m, was analyzed and reached by 18.2% of the verum and 2.1% of the placebo patients (odds ratio 10; 95% CI 3.03-33.33). 1 conventional and 1 complementary drug additionally showed to have significant pleiotropic effects (Padma 28 and cilostazol (e.g. reduction of triglycerides)). According to meta-analytic evidence, naftidrofuryl and Padma 28 show clinically relevant efficacy for the treatment of early stages of PAOD. The extent to which the theoretically possible combination of different drugs contributes to improve the systemic disease under a network-pharmacological rationale remains to be shown in a multi-armed RCT.

Corporate Culture Assessments in Integrative Oncology: A Qualitative Case Study of Two Integrative Oncology Centers

PubMed Central

Mittring, Nadine; Pérard, Marion; Witt, Claudia M.

2013-01-01

The offer of “integrative oncology” is one option for clinics to provide safe and evidence-based complementary medicine treatments to cancer patients. As known from merger theories, corporate culture and integration models have a strong influence on the success of such integration. To identify relevant corporate culture aspects that might influence the success in two highly visible integrative oncology clinics, we interviewed physicians, nurses, practitioners, and managers. All interviews (11 in a German breast cancer clinic and 9 in an integrative medicine cancer service in the USA) were audio-recorded, transcribed and analyzed with content analysis. According to the theoretical framework of mergers, each clinic selected a different integration type (“best of both worlds” and “linking”). Nonetheless, each developed a similar corporate culture that has a strong focus on research and safe and evidence-based treatments, and fosters a holistic and patient-centered approach. Structured communication within the team and with other departments had high relevance. Research was highlighted as a way to open doors and to facilitate a more general acceptance within the hospital. Conventional physicians felt unburdened by the provision of integrative medicine service but also saw problems in the time required for scheduled treatments, which often resulted in long waiting lists. PMID:23818923

Corporate culture assessments in integrative oncology: a qualitative case study of two integrative oncology centers.

PubMed

Mittring, Nadine; Pérard, Marion; Witt, Claudia M

2013-01-01

The offer of "integrative oncology" is one option for clinics to provide safe and evidence-based complementary medicine treatments to cancer patients. As known from merger theories, corporate culture and integration models have a strong influence on the success of such integration. To identify relevant corporate culture aspects that might influence the success in two highly visible integrative oncology clinics, we interviewed physicians, nurses, practitioners, and managers. All interviews (11 in a German breast cancer clinic and 9 in an integrative medicine cancer service in the USA) were audio-recorded, transcribed and analyzed with content analysis. According to the theoretical framework of mergers, each clinic selected a different integration type ("best of both worlds" and "linking"). Nonetheless, each developed a similar corporate culture that has a strong focus on research and safe and evidence-based treatments, and fosters a holistic and patient-centered approach. Structured communication within the team and with other departments had high relevance. Research was highlighted as a way to open doors and to facilitate a more general acceptance within the hospital. Conventional physicians felt unburdened by the provision of integrative medicine service but also saw problems in the time required for scheduled treatments, which often resulted in long waiting lists.

Who benefits most from THC:CBD spray? Learning from clinical experience.

PubMed

Koehler, Jürgen

2014-01-01

Patients with multiple sclerosis (MS) represent a diverse and heterogeneous population varying in terms of disease type, its severity and variable progression/time-course, and with regard to the wide range of presenting symptoms. Consequently, detailed experience with individual patients is important to provide examples of therapy to specific patient types. In this article, real-life data from clinical practice showing specific aspects relating to use of 9-delta-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex®) in patients with moderate to severe spasticity resistant to usual therapy will be presented. Three common clinical scenarios will be considered: MS patients with resistance to usual spasticity therapies; patients with impairment in MS spasticity symptoms; MS patients with relevant impairment in quality of life/activities of daily living (QoL/ADL). These case reports highlight the diverse nature of the MS spasticity population and they show the possible usefulness of THC:CBD oromucosal spray in individual patients with moderate to severe spasticity resistant to existing therapies, within the frame of use approved after large clinical trial results. Perhaps the most important finding is the possibility of obtaining relevant improvements in QoL/ADL in some patients with resistant MS spasticity, allowing them to engage back in physical and social activities. © 2014 S. Karger AG, Basel.

Neurofibromatosis: chronological history and current issues.

PubMed

Antônio, João Roberto; Goloni-Bertollo, Eny Maria; Trídico, Lívia Arroyo

2013-01-01

Neurofibromatosis, which was first described in 1882 by Von Recklinghausen, is a genetic disease characterized by a neuroectodermal abnormality and by clinical manifestations of systemic and progressive involvement which mainly affect the skin, nervous system, bones, eyes and possibly other organs. The disease may manifest in several ways and it can vary from individual to individual. Given the wealth of information about neurofibromatosis, we attempted to present this information in different ways. In the first part of this work, we present a chronological history, which describes the evolution of the disease since the early publications about the disorder until the conclusion of this work, focusing on relevant aspects which can be used by those wishing to investigate this disease. In the second part, we present an update on the various aspects that constitute this disease.

Neurofibromatosis: chronological history and current issues*

PubMed Central

Antônio, João Roberto; Goloni-Bertollo, Eny Maria; Trídico, Lívia Arroyo

2013-01-01

Neurofibromatosis, which was first described in 1882 by Von Recklinghausen, is a genetic disease characterized by a neuroectodermal abnormality and by clinical manifestations of systemic and progressive involvement which mainly affect the skin, nervous system, bones, eyes and possibly other organs. The disease may manifest in several ways and it can vary from individual to individual. Given the wealth of information about neurofibromatosis, we attempted to present this information in different ways. In the first part of this work, we present a chronological history, which describes the evolution of the disease since the early publications about the disorder until the conclusion of this work, focusing on relevant aspects which can be used by those wishing to investigate this disease. In the second part, we present an update on the various aspects that constitute this disease. PMID:23793209

Neuroimaging Techniques: a Conceptual Overview of Physical Principles, Contribution and History

NASA Astrophysics Data System (ADS)

Minati, Ludovico

2006-06-01

This paper is meant to provide a brief overview of the techniques currently used to image the brain and to study non-invasively its anatomy and function. After a historical summary in the first section, general aspects are outlined in the second section. The subsequent six sections survey, in order, computed tomography (CT), morphological magnetic resonance imaging (MRI), functional magnetic resonance imaging (fMRI), diffusion-tensor magnetic resonance imaging (DWI/DTI), positron emission tomography (PET), and electro- and magneto-encephalography (EEG/MEG) based imaging. Underlying physical principles, modelling and data processing approaches, as well as clinical and research relevance are briefly outlined for each technique. Given the breadth of the scope, there has been no attempt to be comprehensive. The ninth and final section outlines some aspects of active research in neuroimaging.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Minati, Ludovico

This paper is meant to provide a brief overview of the techniques currently used to image the brain and to study non-invasively its anatomy and function. After a historical summary in the first section, general aspects are outlined in the second section. The subsequent six sections survey, in order, computed tomography (CT), morphological magnetic resonance imaging (MRI), functional magnetic resonance imaging (fMRI), diffusion-tensor magnetic resonance imaging (DWI/DTI), positron emission tomography (PET), and electro- and magneto-encephalography (EEG/MEG) based imaging. Underlying physical principles, modelling and data processing approaches, as well as clinical and research relevance are briefly outlined for each technique. Givenmore » the breadth of the scope, there has been no attempt to be comprehensive. The ninth and final section outlines some aspects of active research in neuroimaging.« less

Fetal therapy for Down syndrome: an ethical exploration.

PubMed

de Wert, Guido; Dondorp, Wybo; Bianchi, Diana W

2017-03-01

Parallel to recent advances in prenatal screening for Down syndrome (DS), therapies for different aspects of the condition have become available. As intellectual disability is a key aspect, this is an active area for research. Several groups have hypothesized that prenatal interventions will give better chances at improving cognitive functioning in persons with DS than postnatal treatment. Clinical trials are being developed. We first discuss the ethical pros and cons of trying to improve cognitive functioning in persons with DS to see if there are categorical objections to the general idea, and then move on to explore ethically relevant aspects of the prospect of developing fetal therapy for DS (FTDS). Only on the basis of a one-dimensional emphasis on the social model of disability would (fetal) therapy aimed at cognitive improvement be inherently problematic. Inviting pregnant women to participate in FTDS-research should be based on adequate pre-clinical trials, as well as information aimed at avoiding the so-called 'therapeutic misconception'. Should FTDS be proven to be effective and safe, women carrying a fetus with trisomy 21 who have decided to continue the pregnancy may have a moral obligation to make use of this option. © 2016 John Wiley & Sons, Ltd. © 2016 John Wiley & Sons, Ltd.

Retinal imaging and image analysis.

PubMed

Abràmoff, Michael D; Garvin, Mona K; Sonka, Milan

2010-01-01

Many important eye diseases as well as systemic diseases manifest themselves in the retina. While a number of other anatomical structures contribute to the process of vision, this review focuses on retinal imaging and image analysis. Following a brief overview of the most prevalent causes of blindness in the industrialized world that includes age-related macular degeneration, diabetic retinopathy, and glaucoma, the review is devoted to retinal imaging and image analysis methods and their clinical implications. Methods for 2-D fundus imaging and techniques for 3-D optical coherence tomography (OCT) imaging are reviewed. Special attention is given to quantitative techniques for analysis of fundus photographs with a focus on clinically relevant assessment of retinal vasculature, identification of retinal lesions, assessment of optic nerve head (ONH) shape, building retinal atlases, and to automated methods for population screening for retinal diseases. A separate section is devoted to 3-D analysis of OCT images, describing methods for segmentation and analysis of retinal layers, retinal vasculature, and 2-D/3-D detection of symptomatic exudate-associated derangements, as well as to OCT-based analysis of ONH morphology and shape. Throughout the paper, aspects of image acquisition, image analysis, and clinical relevance are treated together considering their mutually interlinked relationships.

Retinal Imaging and Image Analysis

PubMed Central

Abràmoff, Michael D.; Garvin, Mona K.; Sonka, Milan

2011-01-01

Many important eye diseases as well as systemic diseases manifest themselves in the retina. While a number of other anatomical structures contribute to the process of vision, this review focuses on retinal imaging and image analysis. Following a brief overview of the most prevalent causes of blindness in the industrialized world that includes age-related macular degeneration, diabetic retinopathy, and glaucoma, the review is devoted to retinal imaging and image analysis methods and their clinical implications. Methods for 2-D fundus imaging and techniques for 3-D optical coherence tomography (OCT) imaging are reviewed. Special attention is given to quantitative techniques for analysis of fundus photographs with a focus on clinically relevant assessment of retinal vasculature, identification of retinal lesions, assessment of optic nerve head (ONH) shape, building retinal atlases, and to automated methods for population screening for retinal diseases. A separate section is devoted to 3-D analysis of OCT images, describing methods for segmentation and analysis of retinal layers, retinal vasculature, and 2-D/3-D detection of symptomatic exudate-associated derangements, as well as to OCT-based analysis of ONH morphology and shape. Throughout the paper, aspects of image acquisition, image analysis, and clinical relevance are treated together considering their mutually interlinked relationships. PMID:22275207

Systemic Sclerosis Disease Modification Clinical Trials Design: Quo Vadis?

PubMed Central

Mendoza, Fabian A.; Keyes-Elstein, Lynette L.; Jimenez, Sergio A.

2012-01-01

The purpose of this manuscript is to discuss relevant aspects of clinical trials for Systemic Sclerosis (SSc) and to identify important considerations for the design of SSc disease modification clinical trials. Placebo randomized controlled trials with appropriate identification of SSc patients with diffuse progressive SSc skin involvement of recent onset, along with a rescue strategy for patients with worsening lung and skin involvement are suggested. If change in skin thickening is a major outcome of the study, the selection of patients with recent onset of disease and a predetermined degree of skin involvement are crucial requirements. The trial duration should be of at least 12 months. Sample size calculations should consider differences that exceed the Minimal Important Difference. Other relevant trial designs and potential threats to study validity are also discussed. Previous SSc-disease modifying trials have been beset by high dropout rates. Analyses on the subset of subjects completing the trial or applying the last-observation-carried-forward approach can potentially lead to biased estimates and false conclusions. Strategies for retention of subjects should be included at the design stage and analyses to account for missing data should be performed. PMID:22422541

Dissociative Disorders: Between Neurosis and Psychosis

PubMed Central

Devillé, C.; Moeglin, C.; Sentissi, O.

2014-01-01

Dissociative disorders are a set of disorders defined by a disturbance affecting functions that are normally integrated with a prevalence of 2.4 percent in industrialised countries. These disorders are often poorly diagnosed or misdiagnosed because of sharing common clinical features with psychotic disorders, but requiring a very different trajectory of care. Repeated clinical situations in a crisis centre in Geneva provided us with a critical overview of current evidence of knowledge in clinical and etiopathological field about dissociative disorders. Because of their multiple expressions and the overlap with psychotic disorders, we focused on the clinical aspects using three different situations to better understand their specificity and to extend our thinking to the relevance of terms “neurosis” and “psychosis.” Finally, we hope that this work might help physicians and psychiatrists to become more aware of this complex set of disorders while making a diagnosis. PMID:25405051

Deep and continuous palliative sedation (terminal sedation): clinical-ethical and philosophical aspects.

PubMed

Materstvedt, Lars Johan; Bosshard, Georg

2009-06-01

Terminal sedation continues to fuel debate. When confronted with a patient for whom terminal sedation is considered a possible treatment option, decision making can be difficult. In this paper we focus on the clinical-ethical issues, with an aim to provide clinicians with ways of framing the issue from an ethical point of view. In addition to the clinical-ethical issues, terminal sedation touches upon interesting and complex questions of an essentially philosophical nature. What it means to be a "person" is one such question, and is a topic that is relevant to clinical, daily practice. Accordingly, in the latter part of this paper we draw briefly on selected philosophical positions to elucidate this question. A doctor's belief of what it means to be a "person" might well affect their actions. For example, if a doctor believes terminal sedation involves the destruction of the person, they might not be willing to proceed with it.

Formulations in Psychotherapy: Admission Interviews and the Conversational Construction of Diagnosis.

PubMed

Bonnin, Juan Eduardo

2017-09-01

In this article, we contribute to understanding the interactional aspects of making clinical diagnosis in mental health care. We observe that therapists, during the "problem presentation" sequence in clinical encounters, often use a specific form of diagnostic formulations to elicit more diagnostically relevant information. By doing so, they often substitute one type of verb with another, following a diagnostic hypothesis. Specifically, in interviews that arrive at a diagnosis of neurosis, therapists formulate with behavioral verbal processes; in interviews that arrive at a diagnosis of psychosis, they do so with material ones. Such formulations often prove useful to define clinical diagnoses. They can, however, also be dangerous in that they may favor the therapist's agenda over the patient's. Our analysis helps therapists not only better understand the diagnostic process but also reflect upon their own use of diagnostic formulations and become aware of the clinical effects of their interactional performance.

Evaluation of the William S. Hall Psychiatric Institute Clinical Psychology Internship: a replication and extension.

PubMed

Stader, Sandra R; Myers, DeRosset; Forand, Angela Q; Holmes, George R; McNulty, George F; Frey, Linda; Bolton, Staci S

2010-12-01

This study extends three earlier investigations involving participants who completed their predoctoral clinical psychology internship at the William S. Hall Psychiatric Institute. Intern graduates (N = 37) evaluated how effectively their internship training prepared them for seven aspects of their current work as practicing psychologists. Participants also rated the relevancy of 24 different internship training experiences to their current work and how much these experiences contributed to their development as clinical psychologists. The present study, in conjunction with the three previous studies, covers most of the 40-year period since the inception of the internship program. Analysis of the current data indicates the internship has improved over time and was deemed an exceptional training experience by its graduates. Findings may be of particular interest to internship directors and faculty interested in improving their training program and those who plan to conduct a self-study to maintain their accreditation for clinical psychology internship.

Evaluating Walking in Patients with Multiple Sclerosis

PubMed Central

Bennett, Susan

2011-01-01

Walking limitations are among the most visible manifestations of multiple sclerosis (MS). Regular walking assessments should be a component of patient management and require instruments that are appropriate from the clinician's and the patient's perspectives. This article reviews frequently used instruments to assess walking in patients with MS, with emphasis on their validity, reliability, and practicality in the clinical setting. Relevant articles were identified based on PubMed searches using the following terms: “multiple sclerosis AND (walking OR gait OR mobility OR physical activity) AND (disability evaluation)”; references of relevant articles were also searched. Although many clinician- and patient-driven instruments are available, not all have been validated in MS, and some are not sensitive enough to detect small but clinically important changes. Choosing among these depends on what needs to be measured, psychometric properties, the clinical relevance of results, and practicality with respect to space, time, and patient burden. Of the instruments available, the clinician-observed Timed 25-Foot Walk and patient self-report 12-Item Multiple Sclerosis Walking Scale have properties that make them suitable for routine evaluation of walking performance. The Dynamic Gait Index and the Timed Up and Go test involve other aspects of mobility, including balance. Tests of endurance, such as the 2- or 6-Minute Walk, may provide information on motor fatigue not captured by other tests. Quantitative measurement of gait kinetics and kinematics, and recordings of mobility in the patient's environment via accelerometry or Global Positioning System odometry, are currently not routinely used in the clinical setting. PMID:24453700

Clinical relevance of cytogenetics to pediatric practice. Postnatal findings of Patau syndrome - Review of 5 cases.

PubMed

Plaiasu, Vasilica; Ochiana, Diana; Motei, Gabriela; Anca, Ioana; Georgescu, Adrian

2010-07-01

Patau syndrome (trisomy 13) is one of the most common chromosomal anomalies clinically characterized by the presence of numerous malformations with a limited survival rate for most cases. Babies are usually identified at birth and the diagnosis is confirmed with genetic testing. In this review we outline the clinical and cytogenetic aspects of trisomy 13 and associated phenotypes for 5 cases analyzed in the last 3 years, referred to our Clinical Genetics Department. For each child cytogenetic analysis was performed to determine the genetic variant; also, the patients were investigated for other associated malformations (cardiac, cerebral, renal, ocular anomalies). All 5 cases presented multiple malformations, including some but not all signs of the classical clinical triad suggestive of Patau syndrome. The cytogenetic investigation confirmed for each case the suspected diagnosis and also indicated the specific genetic variant, this being a valuable information for the genetic counselling of the families. The application of genetic analysis can increase diagnosis and prognosis accuracy and have an impact on clinical management.

Lateral epicondylitis and beyond: imaging of lateral elbow pain with clinical-radiologic correlation.

PubMed

Kotnis, Nikhil A; Chiavaras, Mary M; Harish, Srinivasan

2012-04-01

The diagnosis of lateral epicondylitis is often straightforward and can be made on the basis of clinical findings. However, radiological assessment is valuable where the clinical picture is less clear or where symptoms are refractory to treatment. Demographics, aspects of clinical history, or certain physical signs may suggest an alternate diagnosis. Knowledge of the typical clinical presentation and imaging findings of lateral epicondylitis, in addition to other potential causes of lateral elbow pain, is necessary. These include entrapment of the posterior interosseous and lateral antebrachial cutaneous nerves, posterolateral rotatory instability, posterolateral plica syndrome, Panner's disease, osteochondritis dissecans of the capitellum, radiocapitellar overload syndrome, occult fractures and chondral-osseous impaction injuries, and radiocapitellar arthritis. Knowledge of these potential masquerades of lateral epicondylitis and their characteristic clinical and imaging features is essential for accurate diagnosis. The goal of this review is to provide an approach to the imaging of lateral elbow pain, discussing the relevant anatomy, various causes, and discriminating factors, which will allow for an accurate diagnosis.

Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster.

PubMed

Liedert, B; Bassus, S; Schneider, C K; Kalinke, U; Löwer, J

2007-01-01

This review summarizes scientific, ethical and regulatory aspects of Phase I clinical trials with monoclonal antibodies. The current standard requirements for pre-clinical testing and for clinical study design are presented. The scientific considerations discussed herein are generally applicable, the view on legal requirements for clinical trials refer to the German jurisdiction only. The adverse effects associated with the TGN1412 Phase I trial indicate that the predictive value of pre-clinical animal models requires reevaluation and that, in certain cases, some issues of clinical trial protocols such as dose fixing may need refinement or redesign. Concrete safety measures, which have been proposed as a consequence of the TGN1412 event include introduction of criteria for high-risk antibodies, sequential inclusion of trial participants and implementation of pre-Phase I studies where dose calculation is based on the pre-clinical No Effect Level instead of the No Observed Adverse Effect Level. The recently established European clinical trials database (EUDRACT Database) is a further safety tool to expedite the sharing of relevant information between scientific authorities.

Clinical Summarization Capabilities of Commercially-available and Internally-developed Electronic Health Records

PubMed Central

Laxmisan, A.; McCoy, A.B.; Wright, A.; Sittig, D.F.

2012-01-01

Objective Clinical summarization, the process by which relevant patient information is electronically summarized and presented at the point of care, is of increasing importance given the increasing volume of clinical data in electronic health record systems (EHRs). There is a paucity of research on electronic clinical summarization, including the capabilities of currently available EHR systems. Methods We compared different aspects of general clinical summary screens used in twelve different EHR systems using a previously described conceptual model: AORTIS (Aggregation, Organization, Reduction, Interpretation and Synthesis). Results We found a wide variation in the EHRs’ summarization capabilities: all systems were capable of simple aggregation and organization of limited clinical content, but only one demonstrated an ability to synthesize information from the data. Conclusion Improvement of the clinical summary screen functionality for currently available EHRs is necessary. Further research should identify strategies and methods for creating easy to use, well-designed clinical summary screens that aggregate, organize and reduce all pertinent patient information as well as provide clinical interpretations and synthesis as required. PMID:22468161

A diagnosis-based clinical decision rule for spinal pain part 2: review of the literature

PubMed Central

Murphy, Donald R; Hurwitz, Eric L; Nelson, Craig F

2008-01-01

Background Spinal pain is a common and often disabling problem. The research on various treatments for spinal pain has, for the most part, suggested that while several interventions have demonstrated mild to moderate short-term benefit, no single treatment has a major impact on either pain or disability. There is great need for more accurate diagnosis in patients with spinal pain. In a previous paper, the theoretical model of a diagnosis-based clinical decision rule was presented. The approach is designed to provide the clinician with a strategy for arriving at a specific working diagnosis from which treatment decisions can be made. It is based on three questions of diagnosis. In the current paper, the literature on the reliability and validity of the assessment procedures that are included in the diagnosis-based clinical decision rule is presented. Methods The databases of Medline, Cinahl, Embase and MANTIS were searched for studies that evaluated the reliability and validity of clinic-based diagnostic procedures for patients with spinal pain that have relevance for questions 2 (which investigates characteristics of the pain source) and 3 (which investigates perpetuating factors of the pain experience). In addition, the reference list of identified papers and authors' libraries were searched. Results A total of 1769 articles were retrieved, of which 138 were deemed relevant. Fifty-one studies related to reliability and 76 related to validity. One study evaluated both reliability and validity. Conclusion Regarding some aspects of the DBCDR, there are a number of studies that allow the clinician to have a reasonable degree of confidence in his or her findings. This is particularly true for centralization signs, neurodynamic signs and psychological perpetuating factors. There are other aspects of the DBCDR in which a lesser degree of confidence is warranted, and in which further research is needed. PMID:18694490

The Role of Reader Characteristics in Processing and Learning from Informational Text

ERIC Educational Resources Information Center

Fox, Emily

2009-01-01

This article considers the role of reader characteristics in processing and learning from informational text, as revealed in think-aloud research. A theoretical framework for relevant aspects of readers' processing and products was developed. These relevant aspects included three attentional foci for processing (comprehension, monitoring, and…

The Fabric of Meaning and Subjective Effects in LSD-Induced States Depend on Serotonin 2A Receptor Activation.

PubMed

Preller, Katrin H; Herdener, Marcus; Pokorny, Thomas; Planzer, Amanda; Kraehenmann, Rainer; Stämpfli, Philipp; Liechti, Matthias E; Seifritz, Erich; Vollenweider, Franz X

2017-02-06

A core aspect of the human self is the attribution of personal relevance to everyday stimuli enabling us to experience our environment as meaningful [1]. However, abnormalities in the attribution of personal relevance to sensory experiences are also critical features of many psychiatric disorders [2, 3]. Despite their clinical relevance, the neurochemical and anatomical substrates enabling meaningful experiences are largely unknown. Therefore, we investigated the neuropharmacology of personal relevance processing in humans by combining fMRI and the administration of the mixed serotonin (5-HT) and dopamine receptor (R) agonist lysergic acid diethylamide (LSD), well known to alter the subjective meaning of percepts, with and without pretreatment with the 5-HT 2A R antagonist ketanserin. General subjective LSD effects were fully blocked by ketanserin. In addition, ketanserin inhibited the LSD-induced attribution of personal relevance to previously meaningless stimuli and modulated the processing of meaningful stimuli in cortical midline structures. These findings point to the crucial role of the 5-HT 2A R subtype and cortical midline regions in the generation and attribution of personal relevance. Our results thus increase our mechanistic understanding of personal relevance processing and reveal potential targets for the treatment of psychiatric illnesses characterized by alterations in personal relevance attribution. Copyright © 2017 Elsevier Ltd. All rights reserved.

Influence of religious aspects and personal beliefs on psychological behavior: focus on anxiety disorders

PubMed Central

Agorastos, Agorastos; Demiralay, Cüneyt; Huber, Christian G

2014-01-01

The current paper presents literature relevant to the relationship of religiosity, spirituality, and personal beliefs with mental health and, in particular, anxiety disorders as an empirical narrative review, providing an overview on the most important and clinically relevant research results on the topic. The relationship between religiosity/spirituality, personal beliefs (ie, magical ideation and paranormal beliefs), and mental health has lately been studied extensively, and results have indicated significant associations among these variables. However, scientific approaches to this field are complex and multidimensional, partly leading to poor operationalization, incomparable data, and contradictory results. Literature demonstrates that higher religiosity/spirituality and magical ideation scores have often been associated with increased obsessive–compulsive traits. Similar results could not be confidently replicated for other anxiety disorders. However, it is still unclear if these differences suggest a specific association with obsessive–compulsive traits and reflect deviating etiopathogenetic and cognitive aspects between obsessive–compulsive disorder and other anxiety disorders, or if these results are biased through other factors. Religiosity/spirituality and personal beliefs constitute important parameters of human experience and deserve greater consideration in the psychotherapeutic treatment of psychiatric disorders. PMID:24648780

Studying the neurobiology of human social interaction: Making the case for ecological validity.

PubMed

Hogenelst, Koen; Schoevers, Robert A; aan het Rot, Marije

2015-01-01

With this commentary we make the case for an increased focus on the ecological validity of the measures used to assess aspects of human social functioning. Impairments in social functioning are seen in many types of psychopathology, negatively affecting the lives of psychiatric patients and those around them. Yet the neurobiology underlying abnormal social interaction remains unclear. As an example of human social neuroscience research with relevance to biological psychiatry and clinical psychopharmacology, this commentary discusses published experimental studies involving manipulation of the human brain serotonin system that included assessments of social behavior. To date, these studies have mostly been laboratory-based and included computer tasks, observations by others, or single-administration self-report measures. Most laboratory measures used so far inform about the role of serotonin in aspects of social interaction, but the relevance for real-life interaction is often unclear. Few studies have used naturalistic assessments in real life. We suggest several laboratory methods with high ecological validity as well as ecological momentary assessment, which involves intensive repeated measures in naturalistic settings. In sum, this commentary intends to stimulate experimental research on the neurobiology of human social interaction as it occurs in real life.

[Thyroid diseases in old age. Clinical aspects and therapy. Part 1: Hyperthyroidism].

PubMed

Rudorff, K H; Fahrenkrog, U; Jahnke, K

1981-08-27

The clinical signs of thyroid disease in older people may differ considerably from those in younger patients. The symptoms are often incorrectly interpreted and attributed to old age. The age is also important to the kind of therapy. The normal clinical hyperthyroidism-indices are not relevant in the diagnosis of hyperthyroidism in older patients. Organic symptoms predominate in old age (loss of weight, muscular asthenia, tremor, cardiac arrhythmia, stenocardia, congestive cardiomyopathy). Most of the time they are wrongly interpreted as additional symptoms of old age. Probably it is not the age that causes the difficulties in hyperthyroidism-diagnostics in old age, but the atypical symptoms of solitary or multilocular adenomas, which increase with advancing age. A special symptom of hyperthyroidism in old age, often misinterpreted, is "apathetic" hyperthyroidism. Radioiodotherapy is indicated in older patients with hyperthyroidism.

Enhancing the Therapy Experience Using Principles of Video Game Design.

PubMed

Folkins, John Wm; Brackenbury, Tim; Krause, Miriam; Haviland, Allison

2016-02-01

This article considers the potential benefits that applying design principles from contemporary video games may have on enhancing therapy experiences. Six principles of video game design are presented, and their relevance for enriching clinical experiences is discussed. The motivational and learning benefits of each design principle have been discussed in the education literature as having positive impacts on student motivation and learning and are related here to aspects of clinical practice. The essential experience principle suggests connecting all aspects of the experience around a central emotion or cognitive connection. The discovery principle promotes indirect learning in focused environments. The risk-taking principle addresses the uncertainties clients face when attempting newly learned skills in novel situations. The generalization principle encourages multiple opportunities for skill transfer. The reward system principle directly relates to the scaffolding of frequent and varied feedback in treatment. Last, the identity principle can assist clients in using their newly learned communication skills to redefine self-perceptions. These principles highlight areas for research and interventions that may be used to reinforce or advance current practice.

THE PSYCHOLOGY OF DECISION MAKING AND ITS RELEVANCE TO RADIATION PROTECTION OF THE PATIENT IN MEDICINE.

PubMed

Moores, B Michael

2018-02-01

An analysis and review of the fundamental psychological basis of decision making has been undertaken in respect of radiation protection of the patient in medicine. Both clinical and scientific aspects of patient protection have been considered. Every stage of the clinical process of radiological examinations, from referral through to diagnostic outcome, has been shown to be subject to proven psychological effects including biases, framing, anchoring and prospect theory, which deals with perceived gains and losses. Such factors also influence the scientific aspects of radiation protection of the patient. Justification for the use of single dose reference level (DRL) values has employed framing with substitution or manipulation by accessibility in order to promote their usefulness. The use of DRLs as presently proposed constrains a diverse patient population to a reference or representative person. This approach is shown to represent a public health initiative that largely ignores the ethical basis of patient protection inherent in the Hippocratic Oath. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Training staff serving clients with intellectual disabilities: a meta-analysis of aspects determining effectiveness.

PubMed

van Oorsouw, Wietske M W J; Embregts, Petri J C M; Bosman, Anna M T; Jahoda, Andrew

2009-01-01

The last decades have seen increased emphasis on the quality of training for direct-care staff serving people with intellectual disabilities. Nevertheless, it is unclear what the key aspects of effective training are. Therefore, the aim of the present meta-analysis was to establish the ingredients (i.e., goals, format, and techniques) for staff training that are related to improvements of staff behaviour. Our literature search concentrated on studies that were published in a period of 20 years. Fifty-five studies met the criteria, resulting in 502 single-subject designs and 13 n>1 designs. Results revealed important information relevant to further improvement of clinical practice: (a) the combination of in-service with coaching-on-the-job is the most powerful format, (b) in in-service formats, one should use multiple techniques, and verbal feedback is particularly recommended, and (c) in coaching-on-the-job formats, verbal feedback should be part of the program, as well as praise and correction. To maximize effectiveness, program developers should carefully prepare training goals, training format, and training techniques, which will yield a profit for clinical practice.

(Very) Early technology assessment and translation of predictive biomarkers in breast cancer.

PubMed

Miquel-Cases, Anna; Schouten, Philip C; Steuten, Lotte M G; Retèl, Valesca P; Linn, Sabine C; van Harten, Wim H

2017-01-01

Predictive biomarkers can guide treatment decisions in breast cancer. Many studies are undertaken to discover and translate these biomarkers, yet few biomarkers make it to practice. Before use in clinical decision making, predictive biomarkers need to demonstrate analytical validity, clinical validity and clinical utility. While attaining analytical and clinical validity is relatively straightforward, by following methodological recommendations, the achievement of clinical utility is extremely challenging. It requires demonstrating three associations: the biomarker with the outcome (prognostic association), the effect of treatment independent of the biomarker, and the differential treatment effect between the prognostic and the predictive biomarker (predictive association). In addition, economical, ethical, regulatory, organizational and patient/doctor-related aspects are hampering the translational process. Traditionally, these aspects do not receive much attention until formal approval or reimbursement of a biomarker test (informed by Health Technology Assessment (HTA)) is at stake, at which point the clinical utility and sometimes price of the test can hardly be influenced anymore. When HTA analyses are performed earlier, during biomarker research and development, they may prevent further development of those biomarkers unlikely to ever provide sufficient added value to society, and rather facilitate translation of the promising ones. Early HTA is particularly relevant for the predictive biomarker field, as expensive medicines are under pressure and the need for biomarkers to guide their appropriate use is huge. Closer interaction between clinical researchers and HTA experts throughout the translational research process will ensure that available data and methodologies will be used most efficiently to facilitate biomarker translation. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

[Nihilodermia in psychodermatology].

PubMed

Harth, W; Hermes, B; Seikowski, K; Gieler, U

2007-05-01

"Nihilodermia" refers to a group of difficult "problem" patients in dermatology without objective findings but with recurrent symptoms and stubborn demand for medical examination. These primary emotional disorders are somatoform disorders, but the patients usually strictly deny a psychosocial aspect and expect purely somatic treatment. Clinical patterns include pruritus, pain, paresthesias, feelings of disfiguration, eco-syndromes, erythrophobia and psychogenic pseudoeffluvium. The relevant somatoform disorders in dermatology can be differentiated as somatization disorders, hypochondriacal disorders, somatoform autonomous disorders, persistent somatoform pain disorders and "other somatoform disorders". A precise differential diagnostic division is necessary in order to initiate adequate therapy strategies.

Performance and palliative care: a drama module for medical students.

PubMed

Jeffrey, Ewan James; Goddard, Jen; Jeffrey, David

2012-12-01

This paper describes an innovative 2 weeks module for medical students facilitated by drama educators and a palliative medicine doctor. The module incorporates drama, end-of-life care, teamwork and reflective practice. The module contents, practical aspects of drama teaching and learning outcomes are discussed. Various themes emerged from a study of Harold Pinter's play, The Caretaker, which were relevant to clinical practice: silence, power, communication, uncertainty and unanswered questions. Drama teaching may be one way of enhancing students' confidence, increasing self- awareness, developing ethical thinking and fostering teamworking.

Unusual multifocal granulomatous disease caused by actinomycetous bacteria in a nestling Derbyan parrot (Psittacula derbiana).

PubMed

Park, F J; Jaensch, S

2009-01-01

A nestling Derbyan parrot (Psittacula derbiana) was presented with unusual subcutaneous swellings of the thigh regions, and poor growth. Histological examination revealed actinomycetous bacteria associated with multifocal systemic granulomas. The clinical and pathological findings of the case are presented, and some relevant aspects of actinomycetous bacterial infections in mammals and birds are discussed. Although granulomatous disease is encountered at times in avian species, the actinomycetous bacteria (Nocardia and Actinomyces spp.) have rarely been reported in association with multifocal granulomatous disease in birds.

MO-E-BRE-01: Determination, Minimization and Communication of Uncertainties in Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Van Dyk, J; Palta, J; Bortfeld, T

2014-06-15

Medical Physicists have a general understanding of uncertainties in the radiation treatment process, both with respect to dosimetry and geometry. However, there is a desire to be more quantitative about uncertainty estimation. A recent International Atomic Energy Agency (IAEA) report (about to be published) recommends that we should be as “accurate as reasonably achievable, technical and biological factors being taken into account”. Thus, a single recommendation as a goal for accuracy in radiation therapy is an oversimplification. That report also suggests that individual clinics should determine their own level of uncertainties for their specific treatment protocols. The question is “howmore » do we implement this in clinical practice”? AAPM Monograph 35 (2011 AAPM Summer School) addressed many specific aspects of uncertainties in each of the steps of a course of radiation treatment. The intent of this symposium is: (1) to review uncertainty considerations in the entire radiation treatment process including uncertainty determination for each step and uncertainty propagation for the total process, (2) to consider aspects of robust optimization which optimizes treatment plans while protecting them against uncertainties, and (3) to describe various methods of displaying uncertainties and communicating uncertainties to the relevant professionals. While the theoretical and research aspects will also be described, the emphasis will be on the practical considerations for the medical physicist in clinical practice. Learning Objectives: To review uncertainty determination in the overall radiation treatment process. To consider uncertainty modeling and uncertainty propagation. To highlight the basic ideas and clinical potential of robust optimization procedures to generate optimal treatment plans that are not severely affected by uncertainties. To describe methods of uncertainty communication and display.« less

General practitioners uses and perceptions of voluntary electronic feedback on treatment outcomes - a qualitative study.

PubMed

Lippert, Maria Laura; Kousgaard, Marius Brostrøm; Bjerrum, Lars

2014-11-30

Currently, there is a strong focus on the diffusion and implementation of indicator-based technologies for assessing and improving the quality of care in general practice. The aim of this study was to explore how and for what purposes indicator-based feedback is used by the general practitioners (GPs) and how they perceive it to contribute to their work. Qualitative interviews with nine GPs in two regions in Denmark. The main selection criterion was that the informants had experience with retrieving electronic feedback. The data generation was explorative and open-ended and the analysis took an iterative approach with continuous refinement of themes that emerged from the data. The study identified two main uses of feedback: i) Administration of a regular disease control schedule for patients with chronic disease and ii) Routine monitoring of outcomes for purposes of resource prioritisation and medication management. Both uses were deemed valuable by the GPs, but also as an additional extra to the clinical core task. All the GPs experienced the feedback to be of limited relevance to the most central and challenging aspects of clinical work understood as the care for individuals. This led to different reactions: Some GPs would use the feedback as a point of departure for broader deliberations about individual patient needs and treatment approaches. For others, the perceived limitations decreased their overall motivation to seek feedback. The study points to the importance of clarifying limitations as well as possibilities with respect to different aspects of clinical quality when introducing indicator-based technologies to practitioners. The results also emphasize that an indicator-based approach to quality improvement should not stand alone in general practice since some of the most central and challenging aspects of clinical work are not covered by this approach.

Perception of educational value in clinical rotations by medical students

PubMed Central

Kandiah, David A

2017-01-01

Aim Clinical teaching in Australian medical schools has changed to meet the needs of substantially increased medical student cohorts. As such, formal feedback from these student cohorts is needed about the value they place on the educational input from each clinical rotation. This study aims to determine which aspects of clinical placements are most educationally useful to medical students. Methods In this study, final year medical students from the University of Western Australia (UWA) were surveyed via an anonymous online questionnaire, identifying which clinical placements were found to be the most and the least useful to their learning and the positive aspects of these placements. Two focus groups were conducted prior to the design of the questionnaire to determine the key areas of focus important to medical students. Ethics approval for this study was obtained from the UWA Human Research Ethics Committee. Results Our focus groups were consistent in finding that students enjoyed placements where they were included as a part of the medical team and played a role in patient care. This was consistent with the concept that inclusiveness and participation in the clinical setting are important in developing competence in tasks and skills. The ratio of students to doctors was crucial, with a low ratio given a higher rating as seen in the rural clinical school. Conclusion The results of this project could benefit both the local and national medical curricula in identifying the most effective clinical attachments for learning and preparation for prevocational training. This is relevant especially due to the limited number of clinical placements and growing cohort of medical students. The results of this study can also be extrapolated to international medical education. PMID:28223855

Perception of educational value in clinical rotations by medical students.

PubMed

Kandiah, David A

2017-01-01

Clinical teaching in Australian medical schools has changed to meet the needs of substantially increased medical student cohorts. As such, formal feedback from these student cohorts is needed about the value they place on the educational input from each clinical rotation. This study aims to determine which aspects of clinical placements are most educationally useful to medical students. In this study, final year medical students from the University of Western Australia (UWA) were surveyed via an anonymous online questionnaire, identifying which clinical placements were found to be the most and the least useful to their learning and the positive aspects of these placements. Two focus groups were conducted prior to the design of the questionnaire to determine the key areas of focus important to medical students. Ethics approval for this study was obtained from the UWA Human Research Ethics Committee. Our focus groups were consistent in finding that students enjoyed placements where they were included as a part of the medical team and played a role in patient care. This was consistent with the concept that inclusiveness and participation in the clinical setting are important in developing competence in tasks and skills. The ratio of students to doctors was crucial, with a low ratio given a higher rating as seen in the rural clinical school. The results of this project could benefit both the local and national medical curricula in identifying the most effective clinical attachments for learning and preparation for prevocational training. This is relevant especially due to the limited number of clinical placements and growing cohort of medical students. The results of this study can also be extrapolated to international medical education.

Outcome measures for clinical rehabilitation trials: impairment, function, quality of life, or value?

PubMed

Wade, Derick T

2003-10-01

Choosing outcome measures in rehabilitation research depends on the standard research skills of clear thinking, attention to detail, and minimizing the amount of data collected. In rehabilitation, outcome is more difficult to measure because (1) usually several outcomes are relevant, (2) relevant outcomes are affected by multiple factors in addition to treatment, and (3) even good measures rarely reflect the specific interest of any individual patient or member of the rehabilitation team, leading to some dissent. Measurement of general quality of life is not possible because there is little agreement as to the nature of the construct; moreover, measurement of relevant aspects of quality of life would probably give similar results. Cost in terms of resources can be estimated, but there is no validated or even widely accepted method of relating this to benefit in a fair, open, and rational way. Outcome is best measured at the level of behavior (activities), with other measures being used to aid interpretation.

Ticks and tick-borne diseases: a One Health perspective.

PubMed

Dantas-Torres, Filipe; Chomel, Bruno B; Otranto, Domenico

2012-10-01

Tick-borne diseases are common occurrences in both the medical and veterinary clinical settings. In addition to the constraints related to their diagnosis and clinical management, the control and prevention of these diseases is often difficult, because it requires the disruption of a complex transmission chain, involving vertebrate hosts and ticks, which interact in a constantly changing environment. We provide a contemporary review of representative tick-borne diseases of humans and discuss aspects linked to their medical relevance worldwide. Finally, we emphasize the importance of a One Health approach to tick-borne diseases, calling physicians and veterinarians to unify their efforts in the management of these diseases, several of which are zoonoses. Copyright © 2012 Elsevier Ltd. All rights reserved.

EASD Diabetes Technology Meeting

PubMed Central

2014-01-01

The first diabetes technology meeting organized by the European Diabetes Association covers the range from regulatory aspects, patient safety, about registries to clinical studies. After an intensive discussion about the evidence required for registration and reimbursement on new medical devices and in vitro diagnostics it becomes clear that more and better clinical trials will be required in the future. This was also highlighted by representatives of the American Diabetes Association. The 2 associations will be active in this field of research by a joint committee. This meeting is intended not to become a large-scale meeting focused on education but to provide a platform for an open discussion of experts involved in all areas that are relevant to achieve a meaningful usage of diabetes technology. PMID:24876444

Pharmacogenetics in Latin American populations: regulatory aspects, application to herbal medicine, cardiovascular and psychiatric disorders.

PubMed

Rodeiro, Idania; Remírez-Figueredo, Diadelis; García-Mesa, Milagros; Dorado, Pedro; LLerena, Adrián

2012-01-01

Meeting report of the "Second Symposium on Pharmacology of Cytochrome P450 and Transporters" organized by the Cuban Society of Pharmacology in collaboration with the European Society of Pharmacogenetics and Theranostics (ESPT) and the Ibero-American Network of Pharmacogenetics and Pharmacogenomics (www.ribef.com). The Symposium covered different topics on pharmacogenetics and its clinical implications, focusing on Latin-American populations. The activities of the ESPT were also presented and discussed. The topics addressed were regulatory aspects, the use of pharmacogenetics in pre-clinical research, herbal medicine, and natural products, ending with a discussion about translation into clinical practice, specifically for cardiovascular disorders and psychiatry. Finally, the implication for population diversity in Latin America was also discussed. The RIBEF initiative represents a promising step towards the inclusion of Latin American populations among those to benefit from the implementation of pharmacogenetics in clinical practice. Among current RIBEF activities, the CEIBA.FP Consortium aims to study the variability of pheno- and genotypes in Hispanics that are relevant to pharmacogenetics. For this purpose, populations from Mexico, Cuba, Nicaragua, Costa Rica, Ecuador, Colombia, Brasil, Perú, Chile, Uruguay, Argentina, Portugal, and Spain are currently being studied. The meeting's main conclusion was that population pharmacogenetic studies as well as academic clinical trials might need to be conducted in the different geographic locations/countries. This is important in order to improve drug safety, dosage recommendations, and pharmacovigilance programs, because environmental and ethnic factors vary across locations.

Psychiatrists and termination of pregnancy: clinical, legal and ethical aspects.

PubMed

Morris, Kirsty; Savell, Kristin; Ryan, Christopher J

2012-01-01

To provide practical guidance for psychiatrists asked to conduct an assessment of a woman requesting a termination of pregnancy. The law relevant to termination of pregnancy in each of the Australian states and territories and in New Zealand was synthesised and reviewed, as was the available literature around the key roles for the psychiatrist in these settings. Little is known about the rates of and reasons for terminations in Australasia. The 'lawfulness' of termination varies between jurisdictions and might require a consideration of the woman's mental health. When psychiatrists are asked to assist, their roles can be divided into: assessment and management of the woman's mental health, assessment of the woman's capacity to consent to the termination, assessment of the impact of having a termination or not having a termination upon the woman's mental health, assistance in determining the lawfulness of the proposed termination and, finally, support of the obstetric team providing terminations. The psychiatric assessment of a woman requesting a termination of pregnancy requires an understanding of the ethical issues, the relevant law and a clinical framework within which the psychiatrist can delineate his or her various roles.

A report on older-age bipolar disorder from the International Society for Bipolar Disorders Task Force

PubMed Central

Sajatovic, Martha; Strejilevich, Sergio A; Gildengers, Ariel G; Dols, Annemiek; Al Jurdi, Rayan K; Forester, Brent P; Kessing, Lars Vedel; Beyer, John; Manes, Facundo; Rej, Soham; Rosa, Adriane R; Schouws, Sigfried NTM; Tsai, Shang-Ying; Young, Robert C; Shulman, Kenneth I

2015-01-01

Objectives In the coming generation, older adults with bipolar disorder (BD) will increase in absolute numbers as well as proportion of the general population. This is the first report of the International Society for Bipolar Disorder (ISBD) Task Force on Older-Age Bipolar Disorder (OABD). Methods This task force report addresses the unique aspects of OABD including epidemiology and clinical features, neuropathology and biomarkers, physical health, cognition, and care approaches. Results The report describes an expert consensus summary on OABD that is intended to advance the care of patients, and shed light on issues of relevance to BD research across the lifespan. Although there is still a dearth of research and health efforts focused on older adults with BD, emerging data has brought some answers, innovative questions, and novel perspectives related to the notion of late onset, medical comorbidity, and the vexing issue of cognitive impairment and decline. Conclusions Improving our understanding of the biological, clinical, and social underpinnings relevant to OABD is an indispensable step in building a complete map of BD across the lifespan. PMID:26384588

Assessing the relevance of ecotoxicological studies for regulatory decision making.

PubMed

Rudén, Christina; Adams, Julie; Ågerstrand, Marlene; Brock, Theo Cm; Poulsen, Veronique; Schlekat, Christian E; Wheeler, James R; Henry, Tala R

2017-07-01

Regulatory policies in many parts of the world recognize either the utility of or the mandate that all available studies be considered in environmental or ecological hazard and risk assessment (ERA) of chemicals, including studies from the peer-reviewed literature. Consequently, a vast array of different studies and data types need to be considered. The first steps in the evaluation process involve determining whether the study is relevant to the ERA and sufficiently reliable. Relevance evaluation is typically performed using existing guidance but involves application of "expert judgment" by risk assessors. In the present paper, we review published guidance for relevance evaluation and, on the basis of the practical experience within the group of authors, we identify additional aspects and further develop already proposed aspects that should be considered when conducting a relevance assessment for ecotoxicological studies. From a regulatory point of view, the overarching key aspect of relevance concerns the ability to directly or indirectly use the study in ERA with the purpose of addressing specific protection goals and ultimately regulatory decision making. Because ERA schemes are based on the appropriate linking of exposure and effect estimates, important features of ecotoxicological studies relate to exposure relevance and biological relevance. Exposure relevance addresses the representativeness of the test substance, environmental exposure media, and exposure regime. Biological relevance deals with the environmental significance of the test organism and the endpoints selected, the ecological realism of the test conditions simulated in the study, as well as a mechanistic link of treatment-related effects for endpoints to the protection goal identified in the ERA. In addition, uncertainties associated with relevance should be considered in the assessment. A systematic and transparent assessment of relevance is needed for regulatory decision making. The relevance aspects also need to be considered by scientists when designing, performing, and reporting ecotoxicological studies to facilitate their use in ERA. Integr Environ Assess Manag 2017;13:652-663. © 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC). © 2016 The Authors. Integrated Environmental Assessment and Management Published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

C-arm Cone Beam Computed Tomography: A New Tool in the Interventional Suite.

PubMed

Raj, Santhosh; Irani, Farah Gillan; Tay, Kiang Hiong; Tan, Bien Soo

2013-11-01

C-arm Cone Beam CT (CBCT) is a technology that is being integrated into many of the newer angiography systems in the interventional suite. Due to its ability to provide cross sectional imaging, it has opened a myriad of opportunities for creating new clinical applications. We review the technical aspects, current reported clinical applications and potential benefits of this technology. Searches were made via PubMed using the string "CBCT", "Cone Beam CT", "Cone Beam Computed Tomography" and "C-arm Cone Beam Computed Tomography". All relevant articles in the results were reviewed. CBCT clinical applications have been reported in both vascular and non-vascular interventions. They encompass many aspects of a procedure including preprocedural planning, intraprocedural guidance and postprocedural assessment. As a result, they have allowed the interventionalist to be safer and more accurate in performing image guided procedures. There are however several technical limitations. The quality of images produced is not comparable to conventional computed tomography (CT). Radiation doses are also difficult to quantify when compared to CT and fluoroscopy. CBCT technology in the interventional suite has contributed significant benefits to the patient despite its current limitations. It is a tool that will evolve and potentially become an integral part of imaging guidance for intervention.

A review of the biological and clinical aspects of radiation caries.

PubMed

Aguiar, Gabrielle P; Jham, Bruno C; Magalhães, Cláudia S; Sensi, Luis Guilherme; Freire, Addah R

2009-07-01

The aim of this article is to review the clinical and biological features underlying the development and progression of radiation caries. Although radiotherapy (RT) plays an important role in the management of patients with head and neck cancer (HNC), it is also associated with several undesired side effects such as radiation caries which is a common, yet serious, complication. To review the condition, the Pubmed database was searched using the keywords "radiotherapy," "radiation," "caries," "hyposalivation," "prevention" and "management". Only studies published in the English language were selected. Cross-referencing identified additionally relevant studies. RT leads to alterations in the dentition, saliva, oral microflora, and diet of patients. Consequently, irradiated patients are at increased risk for the development of a rapid, rampant carious process known as radiation caries. Motivation of patients, adequate plaque control, stimulation of salivary flow, fluoride use, and nutritional orientation are essential to reduce the incidence of radiation caries and ultimately improve the quality of life for HNC patients. Radiation caries is an aggressive side effect of RT. Dentists play an important role in the prevention of the condition via comprehensive oral healthcare before, during, and after the active cancer therapy. Dentists should understand the clinical and biological aspects underlying radiation caries to prevent the development of lesions and provide optimal treatment when needed.

Robot-supported assessment of balance in standing and walking.

PubMed

Shirota, Camila; van Asseldonk, Edwin; Matjačić, Zlatko; Vallery, Heike; Barralon, Pierre; Maggioni, Serena; Buurke, Jaap H; Veneman, Jan F

2017-08-14

Clinically useful and efficient assessment of balance during standing and walking is especially challenging in patients with neurological disorders. However, rehabilitation robots could facilitate assessment procedures and improve their clinical value. We present a short overview of balance assessment in clinical practice and in posturography. Based on this overview, we evaluate the potential use of robotic tools for such assessment. The novelty and assumed main benefits of using robots for assessment are their ability to assess 'severely affected' patients by providing assistance-as-needed, as well as to provide consistent perturbations during standing and walking while measuring the patient's reactions. We provide a classification of robotic devices on three aspects relevant to their potential application for balance assessment: 1) how the device interacts with the body, 2) in what sense the device is mobile, and 3) on what surface the person stands or walks when using the device. As examples, nine types of robotic devices are described, classified and evaluated for their suitability for balance assessment. Two example cases of robotic assessments based on perturbations during walking are presented. We conclude that robotic devices are promising and can become useful and relevant tools for assessment of balance in patients with neurological disorders, both in research and in clinical use. Robotic assessment holds the promise to provide increasingly detailed assessment that allows to individually tailor rehabilitation training, which may eventually improve training effectiveness.

A review on Pharmacological and clinical aspects of Linum usitatissimum L.

PubMed

Ansari, Ramin; Zarshenas, Mohammad Mehdi; Dadbakhsh, Amir Hossein

2018-05-20

Linum usitatissimum L., known as common Flax or linseed, from the family Linnaceae, has long been cultivated in different nations due to its applications in medicine and industry. The present study aims to collect nearly all available information about chemical constituents of Flax, as well as pharmacological properties and confirmed clinical usages of it. We searched through databases such as Scopus and PubMed for relevant literatures using the keywords: (Linum usitatissimum), (pharmacology) and (phytochemical) from the beginning to 13 Aug 2017. Nearly 60 relevant papers, relating to pharmacological and phytochemical constituent of L. usitatissimum were selected. According to our researches, various properties were attributed to L. usitatisimum including: antioxidant, immunomodulatory, anti-inflammatory, antimicrobial, Antiprotozoal, insecticidal, Analgesic, anti-hyperlipidemia, Anti-hyperglycemic, Anti-tumor, wound healing and Feticidal activities. There were also many reports to the disease preventive and healing properties of the flax. Diseases like: GI disorders, cardiovascular, urogenital, respiratory diseases and some neurological syndromes were mentioned to be treated by Flax. The application of Flax in drug formulations was also investigated. Despite so much animal studies that have been accomplished, there haven't been enough clinical trials done on pharmacological properties of L. usitatissimum. Therefore this study could be considered as a concise and up to date overview for further facile studies and clinical trials over the valuable plant, L. usitatissimum. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Optimisation of pharmacy content in clinical cancer research protocols: Experience of the United Kingdom Chemotherapy and Pharmacy Advisory Service.

PubMed

Debruyne, Philip R; Johnson, Philip J; Pottel, Lies; Daniels, Susanna; Greer, Rachel; Hodgkinson, Elizabeth; Kelly, Stephen; Lycke, Michelle; Samol, Jens; Mason, Julie; Kimber, Donna; Loucaides, Eileen; Parmar, Mahesh Kb; Harvey, Sally

2015-06-01

Clarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in such protocols have the potential to delay research and jeopardise both patient safety and collection of credible data. The Chemotherapy and Pharmacy Advisory Service was established by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical research protocols. This article reports the scope of Chemotherapy and Pharmacy Advisory Service, its methodology of mandated protocol review and pharmacy-related guidance initiatives and its current impact. Over a 6-year period (2008-2013) since the inception of Chemotherapy and Pharmacy Advisory Service, cancer clinical trial protocols were reviewed by the service, prior to implementation at clinical trial sites. A customised Review Checklist was developed and used by a panel of experts to standardise the review process and report back queries and inconsistencies to chief investigators. Based on common queries, a Standard Protocol Template comprising specific guidance on drug-related content and a Pharmacy Manual Template were developed. In addition, a guidance framework was established to address 'ad hoc' pharmacy-related queries. The most common remarks made at protocol review have been summarised and categorised through retrospective analysis. In order to evaluate the impact of the service, chief investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from chief investigators have been collated and acceptance rates determined. A total of 176 protocols were reviewed. The median number of remarks per protocol was 26, of which 20 were deemed clinically relevant and mainly concerned the drug regimen, support medication, frequency and type of monitoring and drug supply aspects. Further analysis revealed that 62% of chief investigators responded to the review. All responses were positive with an overall acceptance rate of 89% of the proposed protocol changes. Review of pharmacy content of cancer clinical trial protocols is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct. Our service audit revealed that the majority of suggestions were effectively incorporated in the final protocols. The refinement of existing and development of new pharmacy-related guidance documents by Chemotherapy and Pharmacy Advisory Service might aid in better and safer clinical research. © The Author(s) 2015.

Synaptic Loss and the Pathophysiology of PTSD: Implications for Ketamine as a Prototype Novel Therapeutic

PubMed Central

Krystal, John H.; Abdallah, Chadi G.; Averill, Lynette A.; Kelmendi, Benjamin; Harpaz-Rotem, Ilan; Sanacora, Gerard; Southwick, Steven M.; Duman, Ronald S.

2018-01-01

Purpose of Review Studies of the neurobiology and treatment of PTSD have highlighted many aspects of the pathophysiology of this disorder that might be relevant to treatment. The purpose of this review is to highlight the potential clinical importance of an often-neglected consequence of stress models in animals that may be relevant to PTSD: the stress-related loss of synaptic connectivity. Recent Findings Here, we will briefly review evidence that PTSD might be a “synaptic disconnection syndrome” and highlight the importance of this perspective for the emerging therapeutic application of ketamine as a potential rapid-acting treatment for this disorder that may work, in part, by restoring synaptic connectivity. Summary Synaptic disconnection may contribute to the profile of PTSD symptoms that may be targeted by novel pharmacotherapeutics. PMID:28844076

The Australian model of immunization advice and vaccine funding.

PubMed

Nolan, Terry M

2010-04-19

The Australian Government has implemented new arrangements for public funding of vaccines over the past 5 years. By utilising the standard Pharmaceutical Benefits Advisory Committee (PBAC) application process, whether for funding under the National Immunisation Program Schedule (NIP) or under the Pharmaceutical Benefits Scheme (PBS), a predictable and transparent process for vaccine funding recommendations has been established. This process uses the high-level technical resources available through the Australian Technical Advisory Group on Immunisation (ATAGI) to ensure that both vaccine manufacturers and the PBAC are optimally informed about all relevant aspects of population benefits and delivery of vaccines. ATAGI has a long-standing and mutually beneficial dialogue with State and Territory Governments, providers, and vaccine manufacturers to ensure that pipeline awareness, supply issues, and all relevant scientific and clinical details are well understood. Copyright © 2010 Elsevier Ltd. All rights reserved.

26 CFR 31.3306(c)(10)-2 - Services of student in employ of school, college, or university.

Code of Federal Regulations, 2014 CFR

2014-04-01

... is evaluated based on all the relevant facts and circumstances related to the educational aspect of the relationship. The service aspect of the relationship is evaluated based on all the relevant facts... relationship is not affected by the fact that the services performed by the employee may have an educational...

26 CFR 31.3306(c)(10)-2 - Services of student in employ of school, college, or university.

Code of Federal Regulations, 2012 CFR

2012-04-01

... is evaluated based on all the relevant facts and circumstances related to the educational aspect of the relationship. The service aspect of the relationship is evaluated based on all the relevant facts... relationship is not affected by the fact that the services performed by the employee may have an educational...

26 CFR 31.3306(c)(10)-2 - Services of student in employ of school, college, or university.

Code of Federal Regulations, 2010 CFR

2010-04-01

... is evaluated based on all the relevant facts and circumstances related to the educational aspect of the relationship. The service aspect of the relationship is evaluated based on all the relevant facts... relationship is not affected by the fact that the services performed by the employee may have an educational...

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

PubMed

Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

2004-03-01

The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.

Extended, continuous measures of functional status in community dwelling persons with Alzheimer’s and related dementia: Infrastructure, performance, tradeoffs, preliminary data, and promise

PubMed Central

Zylstra, Bradley; Netscher, George; Jacquemot, Julien; Schaffer, Michael; Shen, Galen; Bowhay, Angela D.; Braley, Tamara L.; Possin, Katherine L.; Miller, Bruce L.; Bayen, Alexandre M.; Bonasera, Stephen J.; Schenk, A. Katrin

2018-01-01

Background The past decades have seen phenomenal growth in the availability of inexpensive and powerful personal computing devices. Efforts to leverage these devices to improve health care outcomes promise to remake many aspects of healthcare delivery, but remain in their infancy. New method We describe the development of a mobile health platform designed for daily measures of functional status in ambulatory, community dwelling subjects, including those who have Alzheimer’s disease or related neurodegenerative disorders. Using Smartwatches and Smartphones we measure subject overall activity and outdoor location (to derive their lifespace). These clinically-relevant measures allow us to track a subject’s functional status in their natural environment over prolonged periods of time without repeated visits to healthcare providers. Functional status metrics are integrated with medical information and caregiver reports, which are used by a caregiving team to guide referrals for physician/APRN/NP care. Comparison with Existing Methods We describe the design tradeoffs involved in all aspects of our current system architecture, focusing on decisions with significant impact on system cost, performance, scalability, and user-adherence. Results We provide real-world data from current subject enrollees demonstrating system accuracy and reliability. Conclusions We document real-world feasibility in a group of men and women with dementia that Smartwatches/Smartphones can provide long-term, relevant clinical data regarding individual functional status. We describe the underlying considerations of this system so that interested organizations can adapt and scale our approach to their needs. Finally, we provide a potential agenda to guide development of future systems. PMID:28865985

Extended, continuous measures of functional status in community dwelling persons with Alzheimer's and related dementia: Infrastructure, performance, tradeoffs, preliminary data, and promise.

PubMed

Zylstra, Bradley; Netscher, George; Jacquemot, Julien; Schaffer, Michael; Shen, Galen; Bowhay, Angela D; Braley, Tamara L; Possin, Katherine L; Miller, Bruce L; Bayen, Alexandre M; Bonasera, Stephen J; Schenk, A Katrin

2018-04-15

The past decades have seen phenomenal growth in the availability of inexpensive and powerful personal computing devices. Efforts to leverage these devices to improve health care outcomes promise to remake many aspects of healthcare delivery, but remain in their infancy. We describe the development of a mobile health platform designed for daily measures of functional status in ambulatory, community dwelling subjects, including those who have Alzheimer's disease or related neurodegenerative disorders. Using Smartwatches and Smartphones we measure subject overall activity and outdoor location (to derive their lifespace). These clinically-relevant measures allow us to track a subject's functional status in their natural environment over prolonged periods of time without repeated visits to healthcare providers. Functional status metrics are integrated with medical information and caregiver reports, which are used by a caregiving team to guide referrals for physician/APRN/NP care. COMPARISON: with Existing Methods We describe the design tradeoffs involved in all aspects of our current system architecture, focusing on decisions with significant impact on system cost, performance, scalability, and user-adherence. We provide real-world data from current subject enrollees demonstrating system accuracy and reliability. We document real-world feasibility in a group of men and women with dementia that Smartwatches/Smartphones can provide long-term, relevant clinical data regarding individual functional status. We describe the underlying considerations of this system so that interested organizations can adapt and scale our approach to their needs. Finally, we provide a potential agenda to guide development of future systems. Copyright © 2017 Elsevier B.V. All rights reserved.

Survey Instruments to Assess Patient Experiences With Access and Coordination Across Health Care Settings: Available and Needed Measures.

PubMed

Quinn, Martha; Robinson, Claire; Forman, Jane; Krein, Sarah L; Rosland, Ann-Marie

2017-07-01

Improving access can increase the providers a patient sees, and cause coordination challenges. For initiatives that increase care across health care settings, measuring patient experiences with access and care coordination will be crucial. Map existing survey measures of patient experiences with access and care coordination expected to be relevant to patients accessing care across settings. Preliminarily examine whether aspects of access and care coordination important to patients are represented by existing measures. Structured literature review of domains and existing survey measures related to access and care coordination across settings. Survey measures, and preliminary themes from semistructured interviews of 10 patients offered VA-purchased Community Care, were mapped to identified domains. We identified 31 existing survey instruments with 279 items representing 6 access and 5 care coordination domains relevant to cross-system care. Domains frequently assessed by existing measures included follow-up coordination, primary care access, cross-setting coordination, and continuity. Preliminary issues identified in interviews, but not commonly assessed by existing measures included: (1) acceptability of distance to care site given patient's clinical situation; (2) burden on patients to access and coordinate care and billing; (3) provider familiarity with Veteran culture and VA processes. Existing survey instruments assess many aspects of patient experiences with access and care coordination in cross-system care. Systems assessing cross-system care should consider whether patient surveys accurately reflect the level of patients' concerns with burden to access and coordinate care, and adequately reflect the impact of clinical severity and cultural familiarity on patient preferences.

[Adolescent scoliosis : From deformity to treatment].

PubMed

Schulze, A; Schrading, S; Betsch, M; Quack, V; Tingart, M

2015-11-01

Scoliosis affects up to 6 % of the population. The resulting spine deformity, the increasing risk of back pain, cosmetic aspects, pulmonary disorders if the Cobb angle is > 80°, and the progress of the deformity to > 50° after the end of growth indicate non-operative or operative therapy. In daily clinical practice, the classifications of scoliosis allow the therapy to be adapted. Classifications consider deformity, topography of the scoliosis, and the age at diagnosis. This publication gives an overview of the relevant and most common classifications in the treatment of adolescent scoliosis. For evaluation, the deformity measurement on the coronary radiographic projection of the total spine (Cobb angle) is relevant to therapy. The classification of topography, form, and the sagittal profile of the deformity of the spine are useful for preoperative planning of the fusion level. Classifications that take into account the age at the time of the diagnosis of scoliosis differentiate among early onset scoliosis (younger than 10 years of age), adolescent scoliosis (up to the end of growth), and adult scoliosis. Early onset scoliosis is subdivided by age and etiology. Therapy is derived from the classification of clinical and radiological findings. Classifications that take into account clinical and radiological parameters are essential components of modern scoliosis therapy.

Is attention to detail a similarly strong candidate endophenotype for anorexia nervosa and bulimia nervosa?

PubMed

Roberts, Marion E; Tchanturia, Kate; Treasure, Janet L

2013-08-01

To investigate whether attention to detail is a similarly strong candidate endophenotype of anorexia (AN) and bulimia nervosa (BN), and to explore the incidence and clinical correlates of attention to detail. A total of 266 women (including AN, BN, recovered AN, unaffected sisters of AN/BN & control women) undertook a thorough clinical assessment and were administered two neuropsychological measures of attention to detail (Group Embedded Figure Test; Rey-Osterrieth Complex Figure). Superior attention to detail was found across all AN groups including recovered AN and unaffected AN sisters. Those with BN and their unaffected sisters showed a profile more consistent with poor global integration. The combined effect of superior attention to detail and poor global integration ("weak coherence") was present in 42.3% of active cases and corresponded with a more severe illness, elevated obsessive-compulsive symptoms, and a higher likelihood of comorbid clinical anxiety and self-harm. Attention to detail is a stronger candidate endophenotype of AN compared to BN, where poor global integration may be more relevant. The unique contribution of both aspects of weak coherence (superior attention to detail/poor global integration) requires further exploration and understanding in both eating disorders. Integrating cognitive remediation of these traits into treatment for the subset of patients it is relevant for may improve outcome.

EMEA and Gene Therapy Medicinal Products Development in the European Union

PubMed Central

2003-01-01

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The responsibility for the authorization of clinical trials remains with the national competent authorities (NCA) acting in a harmonized framework from the scientific viewpoint. With the entry into force of a new directive on good clinical practice implementation in clinical trials as of 1 May 2004, procedural aspects will also be harmonized at EU level. Scientifically sound development of medicinal products is the key for the successful registration of dossiers and for contributing to the promotion and protection of public health. The objective of this paper is to introduce the EMEA regulatory processes and scientific activities relevant to GT medicinal products. PMID:12686717

The Journal of Allergy and Clinical Immunology: In Practice 2017 Year in Review.

PubMed

Schatz, Michael; Sicherer, Scott H; Zeiger, Robert S

An impressive number of clinically impactful studies and reviews were published in The Journal of Allergy and Clinical Immunology: In Practice in 2017. As a service to our readers, the editors provide this Year in Review article to highlight and contextualize the advances published over the past year. We include information from articles on asthma, allergic rhinitis, rhinosinusitis, immunotherapy, atopic dermatitis, contact dermatitis, food allergy, anaphylaxis, drug hypersensitivity, urticarial/angioedema, eosinophilic disorders, and immunodeficiency. Within each topic, epidemiologic findings are presented, relevant aspects of prevention are described, and diagnostic and therapeutic advances are enumerated. Treatments discussed include behavioral therapy, allergen avoidance therapy, positive and negative effects of pharmacologic therapy, and various forms of immunologic and desensitization management. We hope this review will help readers consolidate and use this extensive and practical knowledge for the benefit of patients. Copyright © 2018 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Proposed Morphologic Classification of Prostate Cancer With Neuroendocrine Differentiation

PubMed Central

Epstein, Jonathan I.; Amin, Mahul B.; Beltran, Himisha; Lotan, Tamara L.; Mosquera, Juan-Miguel; Reuter, Victor E.; Robinson, Brian D.; Troncoso, Patricia; Rubin, Mark A.

2014-01-01

On July 31, 2013, the Prostate Cancer Foundation assembled a working committee on the molecular biology and pathologic classification of neuroendocrine differentiation in prostate cancer. The committee consisted of genitourinary oncologists, urologists, urological surgical pathologists, basic scientists, and translational researchers, with expertise in this field. It was concluded that the proceedings of the meeting should be reported in 2 manuscripts appealing to different target audiences, one to focus on surgical pathology and the other to review the molecular aspects of this disease. New clinical and molecular data emerging from prostate cancers treated by contemporary androgen deprivation therapies, as well as primary lesions, have highlighted the need for refinement of diagnostic terminology to encompass the full spectrum of neuroendocrine differentiation. It is envisioned that specific criteria associated with the refined diagnostic terminology will lead to clinically relevant pathologic diagnoses that will stimulate further clinical and molecular investigation and identification of appropriate targeted therapies. PMID:24705311

Immunotoxins: magic bullets or misguided missiles?

PubMed

Vitetta, E S; Thorpe, P E; Uhr, J W

1993-05-01

Thirteen years have passed since specific in vitro and in vivo killing of tumour cells by immunotoxins was first described. Why, then, has it taken so long to determine whether these drugs will have a major impact on the treatment of cancer, AIDS and autoimmune disease? The answer is that the transfer of basic discoveries to the clinic is a slow, multistep, interdisciplinary process. Thus, immunotoxin molecules must be designed and redesigned by the basic scientist depending on the efficacy and toxicity shown in vitro and in relevant experimental models. Next, each version must be evaluated by clinicians in humans through a lengthy process (1-3 years) in which the dose regimen is optimized and in which new problems and issues frequently emerge. These problems must again be modelled and studied in animals before additional clinical trials are initiated. In this article, Ellen Vitetta and colleagues discuss both basic and clinical aspects of the development of immunotoxin therapy.

Implications of clinical trial design on sample size requirements.

PubMed

Leon, Andrew C

2008-07-01

The primary goal in designing a randomized controlled clinical trial (RCT) is to minimize bias in the estimate of treatment effect. Randomized group assignment, double-blinded assessments, and control or comparison groups reduce the risk of bias. The design must also provide sufficient statistical power to detect a clinically meaningful treatment effect and maintain a nominal level of type I error. An attempt to integrate neurocognitive science into an RCT poses additional challenges. Two particularly relevant aspects of such a design often receive insufficient attention in an RCT. Multiple outcomes inflate type I error, and an unreliable assessment process introduces bias and reduces statistical power. Here we describe how both unreliability and multiple outcomes can increase the study costs and duration and reduce the feasibility of the study. The objective of this article is to consider strategies that overcome the problems of unreliability and multiplicity.

Respiratory infections due to nontuberculous mycobacterias.

PubMed

Máiz Carro, Luis; Barbero Herranz, Esther; Nieto Royo, Rosa

2018-03-09

The most common infections caused by nontuberculous mycobacteria (NTM) are lung infections. The microorganisms causing these infections most frequently are Mycobacterium avium complex, Mycobacterium kansasii and Mycobacterium abscessus complex. Their incidence has increased in the last three decades. After identifying an NTM in the respiratory tract, clinical and radiological aspects must be considered to determine if isolations are clinically relevant. Predisposing conditions that could contribute to infection must also be investigated. Pulmonary disease due to NTM is presented in three clinical forms: a) pneumonitis due to hypersensitivity; b) fibrocavitary form; and c) nodular-bronchiectasic. The diagnosis of respiratory disease due to NTM does not make it obligatory to immediately initiate treatment. Before initiating the latter, other factors must be considered, such as age, comorbidities, life expectancy, due to the prolonged nature of treatments, with potential side effects and, in many cases, only a slight response to the treatment. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Decision models in the evaluation of psychotropic drugs : useful tool or useless toy?

PubMed

Barbui, Corrado; Lintas, Camilla

2006-09-01

A current contribution in the European Journal of Health Economics employs a decision model to compare health care costs of olanzapine and risperidone treatment for schizophrenia. The model suggests that a treatment strategy of first-line olanzapine is cost-saving over a 1-year period, with additional clinical benefits in the form of avoided relapses in the long-term. From a clinical perspective this finding is indubitably relevant, but can physicians and policy makers believe it? The study is presented in a balanced way, assumptions are based on data extracted from clinical trials published in major psychiatric journals, and the theoretical underpinnings of the model are reasonable. Despite these positive aspects, we believe that the methodology used in this study-the decision model approach-is an unsuitable and potentially misleading tool for evaluating psychotropic drugs. In this commentary, taking the olanzapine vs. risperidone model as an example, arguments are provided to support this statement.

Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing.

PubMed

Kirk, Dwayne D; Robert, Jason Scott

2005-01-01

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons--particularly for orphan diseases without sufficient revenue incentive for industry investment--regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model compromising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.

Clinical relevance of cytogenetics to pediatric practice. Postnatal findings of Patau syndrome – Review of 5 cases

PubMed Central

PLAIASU, Vasilica; OCHIANA, Diana; MOTEI, Gabriela; ANCA, Ioana; GEORGESCU, Adrian

2010-01-01

ABSTRACT Introduction: Patau syndrome (trisomy 13) is one of the most common chromosomal anomalies clinically characterized by the presence of numerous malformations with a limited survival rate for most cases. Babies are usually identified at birth and the diagnosis is confirmed with genetic testing. Materials and methods: In this review we outline the clinical and cytogenetic aspects of trisomy 13 and associated phenotypes for 5 cases analyzed in the last 3 years, referred to our Clinical Genetics Department. For each child cytogenetic analysis was performed to determine the genetic variant; also, the patients were investigated for other associated malformations (cardiac, cerebral, renal, ocular anomalies). Discussion: All 5 cases presented multiple malformations, including some but not all signs of the classical clinical triad suggestive of Patau syndrome. The cytogenetic investigation confirmed for each case the suspected diagnosis and also indicated the specific genetic variant, this being a valuable information for the genetic counselling of the families. Conclusion: The application of genetic analysis can increase diagnosis and prognosis accuracy and have an impact on clinical management. PMID:21977150

Reliability, Validity and Treatment Sensitivity of the Schizophrenia Cognition Rating Scale

PubMed Central

Keefe, Richard S.E.; Davis, Vicki G.; Spagnola, Nathan B.; Hilt, Dana; Dgetluck, Nancy; Ruse, Stacy; Patterson, Thomas L.; Narasimhan, Meera; Harvey, Philip D.

2014-01-01

Cognitive functioning can be assessed with performance-based assessments such as neuropsychological tests and with interview-based assessments. Both assessment methods have the potential to assess whether treatments for schizophrenia improve clinically relevant aspects of cognitive impairment. However, little is known about the reliability, validity and treatment responsiveness of interview-based measures, especially in the context of clinical trials. Data from two studies were utilized to assess these features of the Schizophrenia Cognition Rating Scale (SCoRS). One of the studies was a validation study involving 79 patients with schizophrenia assessed at 3 academic research centers in the US. The other study was a 32-site clinical trial conducted in the US and Europe comparing the effects of encenicline, an alpha-7 nicotine agonist, to placebo in 319 patients with schizophrenia. The SCoRS interviewer ratings demonstrated excellent test-retest reliability in several different circumstances, including those that did not involve treatment (ICC> 0.90), and during treatment (ICC>0.80). SCoRS interviewer ratings were related to cognitive performance as measured by the MCCB (r= −0.35), and demonstrated significant sensitivity to treatment with encenicline compared to placebo (P<.001). These data suggest that the SCoRS has potential as a clinically relevant measure in clinical trials aiming to improve cognition in schizophrenia, and may be useful for clinical practice. The weaknesses of the SCoRS include its reliance on informant information, which is not available for some patients, and reduced validity when patient self-report is the sole information source. PMID:25028065

Reliability, validity and treatment sensitivity of the Schizophrenia Cognition Rating Scale.

PubMed

Keefe, Richard S E; Davis, Vicki G; Spagnola, Nathan B; Hilt, Dana; Dgetluck, Nancy; Ruse, Stacy; Patterson, Thomas D; Narasimhan, Meera; Harvey, Philip D

2015-02-01

Cognitive functioning can be assessed with performance-based assessments such as neuropsychological tests and with interview-based assessments. Both assessment methods have the potential to assess whether treatments for schizophrenia improve clinically relevant aspects of cognitive impairment. However, little is known about the reliability, validity and treatment responsiveness of interview-based measures, especially in the context of clinical trials. Data from two studies were utilized to assess these features of the Schizophrenia Cognition Rating Scale (SCoRS). One of the studies was a validation study involving 79 patients with schizophrenia assessed at 3 academic research centers in the US. The other study was a 32-site clinical trial conducted in the US and Europe comparing the effects of encenicline, an alpha-7 nicotine agonist, to placebo in 319 patients with schizophrenia. The SCoRS interviewer ratings demonstrated excellent test-retest reliability in several different circumstances, including those that did not involve treatment (ICC> 0.90), and during treatment (ICC>0.80). SCoRS interviewer ratings were related to cognitive performance as measured by the MCCB (r=-0.35), and demonstrated significant sensitivity to treatment with encenicline compared to placebo (P<.001). These data suggest that the SCoRS has potential as a clinically relevant measure in clinical trials aiming to improve cognition in schizophrenia, and may be useful for clinical practice. The weaknesses of the SCoRS include its reliance on informant information, which is not available for some patients, and reduced validity when patient's self-report is the sole information source. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

Folded concave penalized learning in identifying multimodal MRI marker for Parkinson’s disease

PubMed Central

Liu, Hongcheng; Du, Guangwei; Zhang, Lijun; Lewis, Mechelle M.; Wang, Xue; Yao, Tao; Li, Runze; Huang, Xuemei

2016-01-01

Background Brain MRI holds promise to gauge different aspects of Parkinson’s disease (PD)-related pathological changes. Its analysis, however, is hindered by the high-dimensional nature of the data. New method This study introduces folded concave penalized (FCP) sparse logistic regression to identify biomarkers for PD from a large number of potential factors. The proposed statistical procedures target the challenges of high-dimensionality with limited data samples acquired. The maximization problem associated with the sparse logistic regression model is solved by local linear approximation. The proposed procedures then are applied to the empirical analysis of multimodal MRI data. Results From 45 features, the proposed approach identified 15 MRI markers and the UPSIT, which are known to be clinically relevant to PD. By combining the MRI and clinical markers, we can enhance substantially the specificity and sensitivity of the model, as indicated by the ROC curves. Comparison to existing methods We compare the folded concave penalized learning scheme with both the Lasso penalized scheme and the principle component analysis-based feature selection (PCA) in the Parkinson’s biomarker identification problem that takes into account both the clinical features and MRI markers. The folded concave penalty method demonstrates a substantially better clinical potential than both the Lasso and PCA in terms of specificity and sensitivity. Conclusions For the first time, we applied the FCP learning method to MRI biomarker discovery in PD. The proposed approach successfully identified MRI markers that are clinically relevant. Combining these biomarkers with clinical features can substantially enhance performance. PMID:27102045

Current Evidence about Nutrition Support in Cardiac Surgery Patients-What Do We Know?

PubMed

Hill, Aileen; Nesterova, Ekaterina; Lomivorotov, Vladimir; Efremov, Sergey; Goetzenich, Andreas; Benstoem, Carina; Zamyatin, Mikhail; Chourdakis, Michael; Heyland, Daren; Stoppe, Christian

2018-05-11

Nutrition support is increasingly recognized as a clinically relevant aspect of the intensive care treatment of cardiac surgery patients. However, evidence from adequate large-scale studies evaluating its clinical significance for patients’ mid- to long-term outcome remains sparse. Considering nutrition support as a key component in the perioperative treatment of these critically ill patients led us to review and discuss our understanding of the metabolic response to the inflammatory burst induced by cardiac surgery. In addition, we discuss how to identify patients who may benefit from nutrition therapy, when to start nutritional interventions, present evidence about the use of enteral and parenteral nutrition and the potential role of pharmaconutrition in cardiac surgery patients. Although the clinical setting of cardiac surgery provides advantages due to its scheduled insult and predictable inflammatory response, researchers and clinicians face lack of evidence and several limitations in the clinical routine, which are critically considered and discussed in this paper.

Council Clinical Perspective: Cardiovascular Health of Patients with Cancer and Cancer Survivors: A Roadmap to the Next Level

PubMed Central

Barac, Ana; Murtagh, Gillian; Carver, Joseph R.; Chen, Ming Hui; Freeman, Andrew M.; Herrmann, Joerg; Iliescu, Cezar; Ky, Bonnie; Mayer, Erica L.; Okwuosa, Tochi M.; Plana, Juan Carlos; Ryan, Thomas D.; Rzeszut, Anne K.; Douglas, Pamela S.

2015-01-01

Many existing and emerging cancer therapies have significant impact on the cardiovascular (CV) health of patients with cancer and cancer survivors. This manuscript examines current aspects of interdisciplinary cardio-oncology clinical care delivery and education in the United States and outlines how these data provide a platform for future development of the field. We present the results of the nationwide survey on cardio-oncology services, practices and opinions, conducted among Chiefs of Cardiology and Program Directors, that demonstrate ranges of clinical activities and identify significant interest for increased educational opportunities and expert training of CV physicians in this field. The survey respondents recognized clinical relevance, but emphasized lack of national guidelines, lack of funds, and limited awareness and infrastructure as the main challenges for development and growth of cardio-oncology. We discuss potential solutions to unmet needs through interdisciplinary collaboration and the active roles of professional societies and other stakeholders. PMID:26112199

Understanding fertilization through intracytoplasmic sperm injection (ICSI)

PubMed Central

Neri, Queenie V.; Lee, Bora; Rosenwaks, Zev; Machaca, Khaled; Palermo, Gianpiero D.

2014-01-01

Summary Since the establishment of in vitro fertilization, it became evident that almost half of the couples failed to achieve fertilization and this phenomenon was attributed to a male gamete dysfunction. The adoption of assisted fertilization techniques particularly ICSI has been able to alleviate male factor infertility by granting the consistent ability of a viable spermatozoon to activate an oocyte. Single sperm injection, by pinpointing the beginning of fertilization, has been an invaluable tool in clarifying the different aspects of early fertilization and syngamy. However, even with ICSI some couples fail to fertilize due to ooplasmic dysmaturity in relation to the achieved nuclear maturation marked by the extrusion of the first polar body. More uncommon are cases where the spermatozoa partially or completely lack the specific oocyte activating factor. In this work, we review the most relevant aspects of fertilization and its failure through assisted reproductive technologies. Attempts at diagnosing and treating clinical fertilization failure are described. PMID:24290744

Managing outpatient consultations: from referral to discharge.

PubMed

Mitchell, Rachael; Jacob, Hannah; Morrissey, Benita; Macaulay, Chloe; Gomez, Kumudini; Fertleman, Caroline

2017-08-01

Although a great deal of paediatric consultations are not urgent, doctors in training spend so much time providing service for acute conditions that they spend little time focusing on outpatient work before they become a consultant. Engaging clinicians in the managerial aspects of providing clinical care is a key to improving outcomes, and this article addresses these aspects of the outpatient consultation from referral to discharge. We aim to provide doctors in training with a tool to use during their training and their first few years as a consultant, to think about how outpatient work is organised and how it can be improved to maximise patient experience. The non-urgent consultation varies across the world; this article is aimed to be relevant to an international audience. 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/.

"Our Only Child Has Died"-A Study of Bereaved Older Chinese Parents.

PubMed

Zheng, Yongqiang; Lawson, Thomas R; Anderson Head, Barbara

2017-03-01

Long and complicated grief is a relevant factor contributing to the deterioration of the older adults' later life quality. In China, the unintentional consequence of the one-child policy has emerged. There, the group of older adults who lost their only child is called shiduers. The current study compared 42 older adults who lost their only child to 33 older adults who have a child, in term of their physical and mental health, and social support. The results confirmed the general deteriorating trend in those aspects of the bereaved Chinese parents' life after their only child's death. The results also revealed the impairments on the shiduers' physical, mental, and social aspects were significant, compared to the clinical diagnosis cutoff points used in Western countries. Unique policy and cultural characteristics are the main factors contributing to the severe impairment of shiduers. Results have implications for policy advocacy and practice intervention in specific cultural environments.

Aspects of sleep disorders in children and adolescents

PubMed Central

Stores, Gregory

2009-01-01

Sleep disorders in children and adolescents is a topic that has been, and remains, neglected in both public health education and professional training. Although much knowledge has been accumulated in recent times, it has been poorly disseminated and, therefore, relatively little is put into practice. Only some general issues can be discussed in this article. The aspects chosen relate mainly to clinical practice, but they also have relevance for research. They concern various differences between sleep disorders in children and those in adults, the occurrence of such disorders in young people, their effects on psychological and physical development, the essential (but often ignored) distinction between sleep problems and their underlying causes (ie, sleep disorders), types of sleep disturbance encountered at different ages during development, and the differential diagnosis of certain parasomnias that are at particular risk of being confused with each other. PMID:19432390

Respiratory complaints in Chinese: cultural and diagnostic specificities.

PubMed

Han, Jiangna; Zhu, Yuanjue; Li, Shunwei; Chen, Xiansheng; Put, Claudia; Van de Woestijne, Karel P; Van den Bergh, Omer

2005-06-01

We investigated the qualitative components of a wide range of Chinese descriptors of dyspnea and associated symptoms, and their relevance for clinical diagnosis. Sixty-one spontaneously reported descriptors were elicited in Chinese patients to make a symptom checklist, which was administered to new groups of patients with different cardiopulmonary diseases, to patients with medically unexplained dyspnea and to healthy subjects. Test-retest reliability was satisfactory for most of the descriptors. A principal component analysis on 61 descriptors yielded the following eight factors: dyspnea-effort of breathing; dyspnea-affective aspect; wheezing; anxiety; tingling; palpitation; coughing and sputum; and dying experience. Although the descriptors of dyspnea-effort of breathing resembled Western wordings and were shared by patients with a variety of diseases, the descriptors of dyspnea-affective aspect appeared to be more culturally specific and were primarily linked to the diagnosis of medically unexplained dyspnea, whereas wheezing was specifically linked to asthma. Three factors of breathlessness were found in Chinese. The descriptors of dyspnea-effort of breathing and wheezing appear to be similar to Western descriptors, whereas the dyspnea-affective aspect seems to bear cultural specificity.

Quality of life in small-scaled homelike nursing homes: an 8-month controlled trial.

PubMed

Kok, Jeroen S; Nielen, Marjan M A; Scherder, Erik J A

2018-02-27

Quality of life is a clinical highly relevant outcome for residents with dementia. The question arises whether small scaled homelike facilities are associated with better quality of life than regular larger scale nursing homes do. A sample of 145 residents living in a large scale care facility were followed over 8 months. Half of the sample (N = 77) subsequently moved to a small scaled facility. Quality of life aspects were measured with the QUALIDEM and GIP before and after relocation. We found a significant Group x Time interaction on measures of anxiety meaning that residents who moved to small scale units became less anxious than residents who stayed on the regular care large-scale units. No significant differences were found on other aspects of quality of life. This study demonstrates that residents who move from a large scale facility to a small scale environment can improve an aspect of quality of life by showing a reduction in anxiety. Current Controlled Trials ISRCTN11151241 . registration date: 21-06-2017. Retrospectively registered.

Comet assay: an essential tool in toxicological research.

PubMed

Glei, M; Schneider, T; Schlörmann, W

2016-10-01

The comet assay is a versatile, reliable, cost-efficient, and fast technique for detecting DNA damage and repair in any tissue. It is useable in almost any cell type and applicable to both eukaryotic and prokaryotic organisms. Instead of highlighting one of the numerous specific aspects of the comet assay, the present review aims at giving an overview about the evolution of this widely applicable method from the first description by Ostling and Johanson to the OECD Guideline 489 for the in vivo mammalian comet assay. In addition, methodical aspects and the influence of critical steps of the assay as well as the evaluation of results and improvements of the method are reviewed. Methodical aspects regarding oxidative DNA damage and repair are also addressed. An overview about the most recent works and relevant cutting-edge reviews based on the comet assay with special regard to, e.g., clinical applications, nanoparticles or environmental risk assessment concludes this review. Taken together, the presented overview raises expectations to further decades of successful applications and enhancements of this excellent method.

Correlations between dentition anomalies and diseases of the of the postural and movement apparatus--a literature review.

PubMed

Korbmacher, Heike; Eggers-Stroeder, Gerald; Koch, Lutz; Kahl-Nieke, Bärbel

2004-05-01

From anatomic and functional aspects the stomatognathic system and the upper cervical spine are closely interlinked. Together with complex neuromuscular relationships, this gives rise to an important field of cooperation between orthodontics and orthopedics. The literature appeals for close interdisciplinary cooperation for patients with syndromes and for those with torticollis and scoliosis. Since orthopedic points of contact are obvious in these special cases, orthopedic aspects are now being taken increasingly into account in farther-reaching studies. With the rising popularity of manual medicine, these aspects are being recognized from the orthopedic point of view too in terms of functional correlations and are being increasingly debated at international congresses and in the literature. Although relevant publications were initially confined to studies of moderate scientific interest or case reports, potential correlations have undergone scientific investigation in recent interdisciplinary studies. Despite the many clinical studies, no unequivocal recommendation can be given for basic conditions under which an orthopedist is bound to be consulted on patients with orthodontic findings. This literature review is aimed at providing an introduction to this still hotly debated issue.

Midwifery education roundtable discussion: transitions to the workplace.

PubMed

Lydon-Rochelle, Mona T; Kantrowitz-Gordon, Ira; Tower, Martha J Jody; Trego, Lori; Lagerberg, Ruth

2002-01-01

A snapshot of four graduates' views on their educational experience at a research institution as well as their perspective on how it prepared them for the challenges they faced in entering the workplace is presented. Discussants stated that research knowledge is a critical aspect to clinical practice. Their educational experience provided them with the ability to understand information technology applications, identify and access relevant scientific research, evaluate the integrity and comparability of research findings, and apply research findings to clinical practice. Areas within the curriculum that were identified as needing more content and/or greater emphasis included primary health care, how to work competently and effectively with persons from diverse cultural, socioeconomic, and racial and ethnic backgrounds, experience with public health providers, and content such as intimate partner violence and adolescent behaviors.

Facial anatomy.

PubMed

Marur, Tania; Tuna, Yakup; Demirci, Selman

2014-01-01

Dermatologic problems of the face affect both function and aesthetics, which are based on complex anatomical features. Treating dermatologic problems while preserving the aesthetics and functions of the face requires knowledge of normal anatomy. When performing successfully invasive procedures of the face, it is essential to understand its underlying topographic anatomy. This chapter presents the anatomy of the facial musculature and neurovascular structures in a systematic way with some clinically important aspects. We describe the attachments of the mimetic and masticatory muscles and emphasize their functions and nerve supply. We highlight clinically relevant facial topographic anatomy by explaining the course and location of the sensory and motor nerves of the face and facial vasculature with their relations. Additionally, this chapter reviews the recent nomenclature of the branching pattern of the facial artery. © 2013 Elsevier Inc. All rights reserved.

EASD diabetes technology meeting: medical associations are on track.

PubMed

Heinemann, Lutz

2014-07-01

The first diabetes technology meeting organized by the European Diabetes Association covers the range from regulatory aspects, patient safety, about registries to clinical studies. After an intensive discussion about the evidence required for registration and reimbursement on new medical devices and in vitro diagnostics it becomes clear that more and better clinical trials will be required in the future. This was also highlighted by representatives of the American Diabetes Association. The 2 associations will be active in this field of research by a joint committee. This meeting is intended not to become a large-scale meeting focused on education but to provide a platform for an open discussion of experts involved in all areas that are relevant to achieve a meaningful usage of diabetes technology. © 2014 Diabetes Technology Society.

Ethical, legal and clinical aspects of live surgery in urology – contemporary issues and a glimpse of the future

PubMed Central

Ferician, Ovidiu Catalin; Latcu, Silviu Constantin; Pricop, Catalin; Bardan, Razvan Tiberiu

2017-01-01

Beside dry and wet lab training, simulators, video tapes, fellowships and clinical visits, live surgery has gained popularity during the last years, being an attraction point at large scientific meetings and at postgraduate courses as well. This type of surgical training raises both ethical and legal issues. Thus, there are professional societies that have banned such meetings, mainly due to safety reasons for the patient. The current article aims to identify and to discuss ethical and legal issues related to the topic, advantages, disadvantages and weak points of this emerging challenge for modern medicine, trying to analyze the issues from all relevant points of view: those of the patient, the surgeon and the session attendant. PMID:28446925

Genetics and Genomics of Acute Neurologic Disorders.

PubMed

Maserati, Megan; Alexander, Sheila A

2018-01-01

Neurologic diseases and injuries are complex and multifactorial, making risk prediction, targeted treatment modalities, and outcome prognostication difficult and elusive. Genetics and genomics have affected clinical practice in many aspects in medicine, particularly cancer treatment. Advancements in knowledge of genetic and genomic variability in neurologic disease and injury are growing rapidly. Although these data are not yet ready for use in clinical practice, research continues to progress and elucidate information that eventually will provide answers to complex neurologic questions and serve as a platform to provide individualized care plans aimed at improving outcomes. This article provides a focused review of relevant literature on genetics, genomics, and common complex neurologic disease and injury likely to be seen in the acute care setting. ©2018 American Association of Critical-Care Nurses.

[Leptospirosis in a family after whitewater rafting in Thailand].

PubMed

Gallardo, C; Williams-Smith, J; Jaton, K; Asner, S; Cheseaux, J-J; Troillet, N; Manuel, O; Berthod, D

2015-04-15

Leptospirosis is a zoonosis found worldwide, with an incidence that is approximately 10 times higher in the tropics than in temperate regions. The main reservoir of leptospirosis is the rat and human infection usually results from exposure to infected animal urine or tissues. Only 10% of cases are symptomatic. We present here two confirmed and two probable cases of leptospirosis in a family returning from whitewater rafting in Thailand, illustrating the wide variety of the clinical manifestations of this infection. Two of the patients were hospitalized and presented a probable Jarisch-Herxheimer reaction after initiation of beta-lactam therapy. The two others patients were treated empirically with doxycycline. We discuss here some relevant aspects of the epidemiology, clinical manifestations, therapy and the challenge of an early diagnosis of leptospirosis.

The correlation between thought-action fusion and religiosity in a normal sample.

PubMed

Rassin, E; Koster, E

2003-03-01

Thought-action fusion (TAF) refers to a set of two cognitive biases that are thought to contribute to the inflation of feelings of responsibility for one's own thoughts, and thus to the development of obsession. Therefore, insight into the origins of TAF is a clinically relevant research topic. The present study examined the association between religiosity and TAF. Undergraduate students (N=100) completed questionnaires concerning religion, TAF and obsessive-compulsive complaints. Results indicate that religiosity is, indeed, correlated with certain aspects of TAF. Furthermore, correlational patterns differed between Catholic and Protestant subsamples.

Stalking behavior in delusional jealousy.

PubMed

Silva, J A; Derecho, D V; Leong, G B; Ferrari, M M

2000-01-01

Stalking behavior has been associated with several mental disorders, both psychotic and non-psychotic. The most frequently associated condition appears to be an individual with primitive personality psychopathology regardless of co-occurring psychotic symptomatology. Among the psychotic symptoms, erotomanic, and jealousy delusions may be the most clinically and torensically relevant. However, delusional jealousy has not been well appreciated in the psychiatric literature as an important contributor to stalking behavior. In this article, we explore the psychiatric, psychosocial, and forensic aspects of stalking in the context of delusional jealousy. We use a case example to highlight important issues in this area.

Metrological Reliability of Medical Devices

NASA Astrophysics Data System (ADS)

Costa Monteiro, E.; Leon, L. F.

2015-02-01

The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

A systematic review of suggestive seizure induction for the diagnosis of psychogenic nonepileptic seizures.

PubMed

Popkirov, Stoyan; Grönheit, Wenke; Wellmer, Jörg

2015-09-01

Suggestive seizure induction is a widely used method for diagnosing psychogenic nonepileptic seizures (PNES). Despite seven decades of multidisciplinary research, however, there is still no unified protocol, no definitive agreement on the ethical framework and no consensus on diagnostic utility. This systematic review surveys the evidence at hand and addresses clinically relevant aspects of suggestive seizure induction. In addition to its use for facilitating the diagnostic process, its mechanism of action and utility in elucidating the psychopathology of PNES will be discussed. Copyright © 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Developing an integrative level-dimensional taxonomy model for rehabilitation psychology research and practice.

PubMed

Mermis, Bernie J

2018-02-01

The present article concerns the development of a taxonomy model for organizing and classifying all aspects of rehabilitation psychology from an integrative level-dimensional conceptualization. This conceptualization is presented as an alternative to a primarily categorical approach to classification. It also assumes a continuity perspective for all aspects of behavior and experience. Development of this taxonomy model involves organizing information relevant to levels/domains of all aspects of behavior and experience, and to constructs describing their underlying components conceptually as well as dimensions which constitute the measurable basis of constructs. A taxonomy model with levels/domains, representative examples of constructs and dimensions is presented as a foundation for development of the present taxonomy model, with specific relevance to rehabilitation psychology. This integrative level-dimensional taxonomy model provides a structure for organizing all aspects of rehabilitation psychology relevant to understanding, assessing, and influencing the rehabilitation process. Suggestions for development and research are provided for the taxonomy model. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example.

PubMed

Armijo-Olivo, Susan; Warren, Sharon; Fuentes, Jorge; Magee, David J

2011-12-01

Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. Copyright © 2011 Elsevier Ltd. All rights reserved.

Positive psychology interventions in breast cancer. A systematic review.

PubMed

Casellas-Grau, Anna; Font, Antoni; Vives, Jaume

2014-01-01

Positive psychology is an emerging area of empirical study, not only in clinical, but also in health psychology. The present systematic review aims to synthesize the evidence about the positive psychology interventions utilized in breast cancer. Relevant studies were identified via Pubmed, PsycINFO, Web of Science, Scopus, Cochrane, CINAHL, Wiley Online Library, TDX, and DIALNET databases (up to April 2013). Only those papers focused on interventions related to positive psychology and carried out on breast cancer patients were included. Of the 7266 articles found through databases, 16 studies were finally included in this review. Five groups of therapies were found: mindfulness-based approaches, expression of positive emotions, spiritual interventions, hope therapy, and meaning-making interventions. These specific interventions promoted positive changes in breast cancer participants, such as enhanced quality of life, well-being, hope, benefit finding, or optimism. However, the disparity of the interventions and some methodological issues limit the outcomes. Some studies provided relevant evidence about the clear development of positive aspects from the breast cancer experience. Positive interventions applied to patients and survivors of breast cancer were found to be able to promote positive aspects. A global consensus of a positive therapies classification is needed to take one more step in structuring positive psychology. Copyright © 2013 John Wiley & Sons, Ltd.

Recommendations for an update of the 2010 European regulatory guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis and reflections about related clinically relevant outcomes: expert consensus statement.

PubMed

Reginster, J-Y; Reiter-Niesert, S; Bruyère, O; Berenbaum, F; Brandi, M-L; Branco, J; Devogelaer, J-P; Herrero-Beaumont, G; Kanis, J; Maggi, S; Maheu, E; Richette, P; Rizzoli, R; Cooper, C

2015-12-01

The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on clinical investigation of drugs used in the treatment of osteoarthritis (OA). Areas of potential attention were identified and the need for modifications, update or clarification was examined. Proposals were then developed based on literature reviews and through a consensus process. It was agreed that the current guideline overall still reflects the current knowledge in OA, although two possible modifications were identified. The first relates to the number and timing of measurements required as primary endpoints during clinical trials of symptom-relieving drugs, either drugs with rapid onset of action or slow acting drugs. The suggested modifications are intended to take into consideration the time related clinical need and expected time response to these drugs - i.e., a more early effect for the first category in addition to the maintenance of effect, a more continuous benefit over the long-term for the latter - in the timing of assessments. Secondly, values above which a benefit over placebo should be considered clinically relevant were considered. Based on literature reviews, the most consensual values were determined for primary endpoints of both symptom-relieving drugs (i.e., pain intensity on a visual analogue scale (VAS)) and disease-modifying drugs (i.e., radiographic joint-space narrowing). This working document might be considered by the European regulatory authorities in a future update of the guideline for the registration of drugs in OA. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

The effectiveness of the bone bridge transtibial amputation technique: A systematic review of high-quality evidence.

PubMed

Kahle, Jason T; Highsmith, M Jason; Kenney, John; Ruth, Tim; Lunseth, Paul A; Ertl, Janos

2017-06-01

This literature review was undertaken to determine if commonly held views about the benefits of a bone bridge technique are supported by the literature. Four databases were searched for articles pertaining to surgical strategies specific to a bone bridge technique of the transtibial amputee. A total of 35 articles were identified as potential articles. Authors included methodology that was applied to separate topics. Following identification, articles were excluded if they were determined to be low quality evidence or not pertinent. Nine articles were identified to be pertinent to one of the topics: Perioperative Care, Acute Care, Subjective Analysis and Function. Two articles sorted into multiple topics. Two articles were sorted into the Perioperative Care topic, 4 articles sorted into the Acute Care topic, 2 articles into the Subjective Analysis topic and 5 articles into the Function topic. There are no high quality (level one or two) clinical trials reporting comparisons of the bone bridge technique to traditional methods. There is limited evidence supporting the clinical outcomes of the bone bridge technique. There is no agreement supporting or discouraging the perioperative and acute care aspects of the bone bridge technique. There is no evidence defining an interventional comparison of the bone bridge technique. Current level III evidence supports a bone bridge technique as an equivalent option to the non-bone bridge transtibial amputation technique. Formal level I and II clinical trials will need to be considered in the future to guide clinical practice. Clinical relevance Clinical Practice Guidelines are evidence based. This systematic literature review identifies the highest quality evidence to date which reports a consensus of outcomes agreeing bone bridge is as safe and effective as alternatives. The clinical relevance is understanding bone bridge could additionally provide a mechanistic advantage for the transtibial amputee.

Standardized Computer-based Organized Reporting of EEG: SCORE

PubMed Central

Beniczky, Sándor; Aurlien, Harald; Brøgger, Jan C; Fuglsang-Frederiksen, Anders; Martins-da-Silva, António; Trinka, Eugen; Visser, Gerhard; Rubboli, Guido; Hjalgrim, Helle; Stefan, Hermann; Rosén, Ingmar; Zarubova, Jana; Dobesberger, Judith; Alving, Jørgen; Andersen, Kjeld V; Fabricius, Martin; Atkins, Mary D; Neufeld, Miri; Plouin, Perrine; Marusic, Petr; Pressler, Ronit; Mameniskiene, Ruta; Hopfengärtner, Rüdiger; Emde Boas, Walter; Wolf, Peter

2013-01-01

The electroencephalography (EEG) signal has a high complexity, and the process of extracting clinically relevant features is achieved by visual analysis of the recordings. The interobserver agreement in EEG interpretation is only moderate. This is partly due to the method of reporting the findings in free-text format. The purpose of our endeavor was to create a computer-based system for EEG assessment and reporting, where the physicians would construct the reports by choosing from predefined elements for each relevant EEG feature, as well as the clinical phenomena (for video-EEG recordings). A working group of EEG experts took part in consensus workshops in Dianalund, Denmark, in 2010 and 2011. The faculty was approved by the Commission on European Affairs of the International League Against Epilepsy (ILAE). The working group produced a consensus proposal that went through a pan-European review process, organized by the European Chapter of the International Federation of Clinical Neurophysiology. The Standardised Computer-based Organised Reporting of EEG (SCORE) software was constructed based on the terms and features of the consensus statement and it was tested in the clinical practice. The main elements of SCORE are the following: personal data of the patient, referral data, recording conditions, modulators, background activity, drowsiness and sleep, interictal findings, “episodes” (clinical or subclinical events), physiologic patterns, patterns of uncertain significance, artifacts, polygraphic channels, and diagnostic significance. The following specific aspects of the neonatal EEGs are scored: alertness, temporal organization, and spatial organization. For each EEG finding, relevant features are scored using predefined terms. Definitions are provided for all EEG terms and features. SCORE can potentially improve the quality of EEG assessment and reporting; it will help incorporate the results of computer-assisted analysis into the report, it will make possible the build-up of a multinational database, and it will help in training young neurophysiologists. PMID:23506075

Development and evaluation of an algorithm-based tool for Medication Management in nursing homes: the AMBER study protocol.

PubMed

Erzkamp, Susanne; Rose, Olaf

2018-04-20

Residents of nursing homes are susceptible to risks from medication. Medication Reviews (MR) can increase clinical outcomes and the quality of medication therapy. Limited resources and barriers between healthcare practitioners are potential obstructions to performing MR in nursing homes. Focusing on frequent and relevant problems can support pharmacists in the provision of pharmaceutical care services. This study aims to develop and evaluate an algorithm-based tool that facilitates the provision of Medication Management in clinical practice. This study is subdivided into three phases. In phase I, semistructured interviews with healthcare practitioners and patients will be performed, and a mixed methods approach will be chosen. Qualitative content analysis and the rating of the aspects concerning the frequency and relevance of problems in the medication process in nursing homes will be performed. In phase II, a systematic review of the current literature on problems and interventions will be conducted. The findings will be narratively presented. The results of both phases will be combined to develop an algorithm for MRs. For further refinement of the aspects detected, a Delphi survey will be conducted. In conclusion, a tool for clinical practice will be created. In phase III, the tool will be tested on MRs in nursing homes. In addition, effectiveness, acceptance, feasibility and reproducibility will be assessed. The primary outcome of phase III will be the reduction of drug-related problems (DRPs), which will be detected using the tool. The secondary outcomes will be the proportion of DRPs, the acceptance of pharmaceutical recommendations and the expenditure of time using the tool and inter-rater reliability. This study intervention is approved by the local Ethics Committee. The findings of the study will be presented at national and international scientific conferences and will be published in peer-reviewed journals. DRKS00010995. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Development and evaluation of an algorithm-based tool for Medication Management in nursing homes: the AMBER study protocol

PubMed Central

Rose, Olaf

2018-01-01

Background Residents of nursing homes are susceptible to risks from medication. Medication Reviews (MR) can increase clinical outcomes and the quality of medication therapy. Limited resources and barriers between healthcare practitioners are potential obstructions to performing MR in nursing homes. Focusing on frequent and relevant problems can support pharmacists in the provision of pharmaceutical care services. This study aims to develop and evaluate an algorithm-based tool that facilitates the provision of Medication Management in clinical practice. Methods and analysis This study is subdivided into three phases. In phase I, semistructured interviews with healthcare practitioners and patients will be performed, and a mixed methods approach will be chosen. Qualitative content analysis and the rating of the aspects concerning the frequency and relevance of problems in the medication process in nursing homes will be performed. In phase II, a systematic review of the current literature on problems and interventions will be conducted. The findings will be narratively presented. The results of both phases will be combined to develop an algorithm for MRs. For further refinement of the aspects detected, a Delphi survey will be conducted. In conclusion, a tool for clinical practice will be created. In phase III, the tool will be tested on MRs in nursing homes. In addition, effectiveness, acceptance, feasibility and reproducibility will be assessed. The primary outcome of phase III will be the reduction of drug-related problems (DRPs), which will be detected using the tool. The secondary outcomes will be the proportion of DRPs, the acceptance of pharmaceutical recommendations and the expenditure of time using the tool and inter-rater reliability. Ethics and dissemination This study intervention is approved by the local Ethics Committee. The findings of the study will be presented at national and international scientific conferences and will be published in peer-reviewed journals. Trial registration number DRKS00010995. PMID:29678967

A Global Oral Health Survey of professional opinion using the International Classification of Functioning, Disability and Health.

PubMed

Dougall, Alison; Molina, Gustavo F; Eschevins, Caroline; Faulks, Denise

2015-06-01

The concept of oral health is frequently reduced to the absence of disease, despite existing conceptual models exploring the wider determinants of oral health and quality of life. The International Classification of Functioning, Disability and Health (ICF) (WHO) is designed to qualify functional, social and environmental aspects of health. This survey aimed to reach a consensual description of adult oral health, derived from the ICF using international professional opinion. The Global Oral Health Survey involved a two-round, online survey concerning factors related to oral health including functioning, participation and social environment. Four hundred eighty-six oral health professionals from 74 countries registered online. Professionals were pooled into 18 groups of six WHO world regions and three professional groups. In a randomised stratification process, eight professionals from each pool (n=144) completed the survey. The first round consisted of eight open-ended questions. Open expression replies were analysed for meaningful concepts and linked using established rules to the ICF. In Round 2, items were rated for their relevance to oral health (88% response rate). Eighty-nine ICF items and 30 other factors were considered relevant by at least 80% of participants. International professionals reached consensus on a holistic description of oral health, which could be qualified and quantified using the ICF. These results represent the first step towards developing an ICF Core Set in Oral Health, which would provide a practical tool for reporting outcome measures in clinical practice, for research and epidemiology, and for the improvement of interdisciplinary communication regarding oral health. Professional consensus reached in this survey is the foundation stone for developing an ICF Core Set in Oral Health, allowing the holistic aspects of oral health to be qualified and quantified. This tool is necessary to widen our approach to clinical decision making, measurement of clinical outcomes, research and epidemiology. Copyright © 2015 Elsevier Ltd. All rights reserved.

Do High-Functioning People with Autism Spectrum Disorder Spontaneously Use Event Knowledge to Selectively Attend to and Remember Context-Relevant Aspects in Scenes?

ERIC Educational Resources Information Center

Loth, Eva; Gomez, Juan Carlos; Happe, Francesca

2011-01-01

This study combined an event schema approach with top-down processing perspectives to investigate whether high-functioning children and adults with autism spectrum disorder (ASD) spontaneously attend to and remember context-relevant aspects of scenes. Participants read one story of story-pairs (e.g., burglary or tea party). They then inspected a…

26 CFR 31.3121(b)(10)-2 - Services performed by certain students in the employ of a school, college, or university, or of a...

Code of Federal Regulations, 2012 CFR

2012-04-01

... is evaluated based on all the relevant facts and circumstances related to the educational aspect of the relationship. The service aspect of the relationship is evaluated based on all the relevant facts... relationship is not affected by the fact that the services performed by the employee may have an educational...

26 CFR 31.3121(b)(10)-2 - Services performed by certain students in the employ of a school, college, or university, or of a...

Code of Federal Regulations, 2014 CFR

2014-04-01

... is evaluated based on all the relevant facts and circumstances related to the educational aspect of the relationship. The service aspect of the relationship is evaluated based on all the relevant facts... relationship is not affected by the fact that the services performed by the employee may have an educational...

Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go.

PubMed

Imran, Mohammed; Najmi, Abul K; Rashid, Mohammad F; Tabrez, Shams; Shah, Mushtaq A

2013-01-01

The Central Drugs Standard Control Organisation and its chairman Drug Controller general of India are bequeathed to protect the citizens from the marketing of unsafe medication. The startling findings, of the 59(th)report of the Parliamentary Standing Committee on Health and Family Welfare, have uncovered the lax standards followed by the regulatory authorities in India. The growing clinical research after the product patents rights for the pharmaceutical industries as per the trade related aspects of intellectual property rights agreement and adverse drug reaction monitoring of the marketed drugs have raised many ethical and regulatory issues regarding the promotion of new drugs in Indian markets. Many controversial group of medicines; unauthorised and irrational FDCs not relevant to India's medical needs, are available which are not sold in any of the countries with matured regulatory bodies. It becomes vital to understand the history, growth and evolution of the regulatory aspects of drugs which are handled by multiple Ministries and Departments of the Government of India. Although amendment to Schedule Y, registration of Contract Research Organisations, registration of Clinical Trials, Speeding up review process, Pharmacovigilance (PhV) programme for India and Inspection of clinical trial sites have been started by the various regulatory agencies. However due to casual approach in marketing approval for sale of the drugs, the unethical steps taken by some pharmaceutical companies and medical practitioners has reiterated the need to get appropriate understanding of present regulation of drugs and clinical research especially regarding the practical rules and regulations.

Balancing benefits and risks of glucocorticoids in rheumatic diseases and other inflammatory joint disorders: new insights from emerging data. An expert consensus paper from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).

PubMed

Cooper, Cyrus; Bardin, Thomas; Brandi, Maria-Luisa; Cacoub, Patrice; Caminis, John; Civitelli, Roberto; Cutolo, Maurizio; Dere, Willard; Devogelaer, Jean-Pierre; Diez-Perez, Adolfo; Einhorn, Thomas A; Emonts, Patrick; Ethgen, Olivier; Kanis, John A; Kaufman, Jean-Marc; Kvien, Tore K; Lems, Willem F; McCloskey, Eugene; Miossec, Pierre; Reiter, Susanne; Ringe, Johann; Rizzoli, René; Saag, Kenneth; Reginster, Jean-Yves

2016-02-01

This consensus review article considers the question of whether glucocorticoid (GC) therapy is still relevant in the treatment of rheumatic diseases, with a particular focus on rheumatoid arthritis (RA), and whether its side effects can be adequately managed. Recent basic and clinical research on the molecular, cellular and clinical effects of GCs have considerably advanced our knowledge in this field. An overview of the subject seems appropriate. This review is the result of a multidisciplinary expert working group, organised by European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis. The recent literature was surveyed and the salient evidence synthetized. The pathophysiological basis of RA (and other inflammatory rheumatic diseases) now strongly implicates the adaptive immune system in addition to innate mechanisms. The molecular effect of GCs and differential GC sensitivity is better understood, although exploiting this knowledge is still in its infancy. The newer treatment strategies of early and aggressive control of RA have gr eatly improved clinical outcomes, but improvements are still possible. Newer targeted anti-inflammatory drugs have made an important impact, yet they too are associated with numerous side effects. Short durations of moderate doses of GCs are generally well tolerated and have a positive benefit/risk ratio. Patients should be assessed for fracture risk and bone preserving agents and be prescribed calcium and vitamin D supplementation. Within a strategy of a disease modifying approach to inflammatory disease, combination therapy including a GC is effective approach.

Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go

PubMed Central

Imran, Mohammed; Najmi, Abul K.; Rashid, Mohammad F.; Tabrez, Shams; Shah, Mushtaq A.

2013-01-01

The Central Drugs Standard Control Organisation and its chairman Drug Controller general of India are bequeathed to protect the citizens from the marketing of unsafe medication. The startling findings, of the 59threport of the Parliamentary Standing Committee on Health and Family Welfare, have uncovered the lax standards followed by the regulatory authorities in India. The growing clinical research after the product patents rights for the pharmaceutical industries as per the trade related aspects of intellectual property rights agreement and adverse drug reaction monitoring of the marketed drugs have raised many ethical and regulatory issues regarding the promotion of new drugs in Indian markets. Many controversial group of medicines; unauthorised and irrational FDCs not relevant to India's medical needs, are available which are not sold in any of the countries with matured regulatory bodies. It becomes vital to understand the history, growth and evolution of the regulatory aspects of drugs which are handled by multiple Ministries and Departments of the Government of India. Although amendment to Schedule Y, registration of Contract Research Organisations, registration of Clinical Trials, Speeding up review process, Pharmacovigilance (PhV) programme for India and Inspection of clinical trial sites have been started by the various regulatory agencies. However due to casual approach in marketing approval for sale of the drugs, the unethical steps taken by some pharmaceutical companies and medical practitioners has reiterated the need to get appropriate understanding of present regulation of drugs and clinical research especially regarding the practical rules and regulations. PMID:23559817

Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

PubMed

Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

2017-06-01

The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective

PubMed Central

Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

2017-01-01

Aim The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. Methods A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. Results The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Conclusions Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers. PMID:28276780

Economic evaluation of pharmacist-led medication reviews in residential aged care facilities.

PubMed

Hasan, Syed Shahzad; Thiruchelvam, Kaeshaelya; Kow, Chia Siang; Ghori, Muhammad Usman; Babar, Zaheer-Ud-Din

2017-10-01

Medication reviews is a widely accepted approach known to have a substantial impact on patients' pharmacotherapy and safety. Numerous options to optimise pharmacotherapy in older people have been reported in literature and they include medication reviews, computerised decision support systems, management teams, and educational approaches. Pharmacist-led medication reviews are increasingly being conducted, aimed at attaining patient safety and medication optimisation. Cost effectiveness is an essential aspect of a medication review evaluation. Areas covered: A systematic searching of articles that examined the cost-effectiveness of medication reviews conducted in aged care facilities was performed using the relevant databases. Pharmacist-led medication reviews confer many benefits such as attainment of biomarker targets for improved clinical outcomes, and other clinical parameters, as well as depict concrete financial advantages in terms of decrement in total medication costs and associated cost savings. Expert commentary: The cost-effectiveness of medication reviews are more consequential than ever before. A critical evaluation of pharmacist-led medication reviews in residential aged care facilities from an economical aspect is crucial in determining if the time, effort, and direct and indirect costs involved in the review rationalise the significance of conducting medication reviews for older people in aged care facilities.

Drug screening in 3D in vitro tumor models: overcoming current pitfalls of efficacy read-outs.

PubMed

Santo, Vítor E; Rebelo, Sofia P; Estrada, Marta F; Alves, Paula M; Boghaert, Erwin; Brito, Catarina

2017-01-01

There is cumulating evidence that in vitro 3D tumor models with increased physiological relevance can improve the predictive value of pre-clinical research and ultimately contribute to achieve decisions earlier during the development of cancer-targeted therapies. Due to the role of tumor microenvironment in the response of tumor cells to therapeutics, the incorporation of different elements of the tumor niche on cell model design is expected to contribute to the establishment of more predictive in vitro tumor models. This review is focused on the several challenges and adjustments that the field of oncology research is facing to translate these advanced tumor cells models to drug discovery, taking advantage of the progress on culture technologies, imaging platforms, high throughput and automated systems. The choice of 3D cell model, the experimental design, choice of read-outs and interpretation of data obtained from 3D cell models are critical aspects when considering their implementation in drug discovery. In this review, we foresee some of these aspects and depict the potential directions of pre-clinical oncology drug discovery towards improved prediction of drug efficacy. Copyright © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

DIAGNOSIS AND TREATMENT OF POSTERIOR INTEROSSEOUS NERVE ENTRAPMENT: SYSTEMATIC REVIEW

PubMed Central

MORAES, MARCO AURÉLIO DE; GONÇALVES, RUBENS GUILHERME; SANTOS, JOÃO BAPTISTA GOMES DOS; BELLOTI, JOÃO CARLOS; FALOPPA, FLÁVIO; MORAES, VINÍCIUS YNOE DE

2017-01-01

ABSTRACT Compressive syndromes of the radial nerve have different presentations. There is no consensus on diagnostic and therapeutic methods. The aim of this review is to summarize such methods. Eletronic searches related terms, held in databases (1980-2016): Pubmed (via Medline), Lilacs (via Scielo) and Google Scholar. Through pre-defined protocol, we identified relevant studies. We excluded case reports. Aspects of diagnosis and treatment were synthesized for analysis and tables. Quantitative analyzes were followed by their dispersion variables. Fourteen studies were included. All studies were considered as level IV evidence. Most studies consider aspects of clinical history and provocative maneuvers. There is no consensus on the use of electromyography, and methods are heterogeneous. Studies have shown that surgical treatment (muscle release and neurolysis) has variable success rate, ranging from 20 to 96.5%. Some studies applied self reported scores, though the heterogeneity of the population does not allow inferential analyzes on the subject. few complications reported. Most studies consider the diagnosis of compressive radial nerve syndromes essentially clinical. The most common treatment was combined muscle release and neurolysis, with heterogeneous results. There is a need for comparative studies. Level of Evidence III, Systematic Review. PMID:28642652

Alterations in hair follicle dynamics in women.

PubMed

Piérard-Franchimont, Claudine; Piérard, Gérald E

2013-01-01

Endocrine changes supervening after parturition and menopause participate in the control of sebum production and hair growth modulation. The ensuing conditions include some peculiar aspects of hair loss (effluvium), alopecia, and facial hirsutism. The hair cycling is of major clinical relevance because most hair growth disorders result from disturbances in this chronobiological feature. Of note, any correlation between a biologic abnormality and hair cycling disturbance does not prove a relationship of causality. The proportion of postmenopausal women is rising in the overall population. Therefore, the prevalence of these hair follicle disturbances is globally on the rise. Current therapies aim at correcting the underlying hormonal imbalances, and at improving the overall cosmetic appearance. However, in absence of pathogenic diagnosis and causality criteria, chances are low that a treatment given by the whims of fate will adequately control hair effluvium. The risk and frequency of therapeutic inertia are further increased. When the hair loss is not controlled and/or compensated by growth of new hairs, several clinical aspects of alopecia inexorably develop. Currently, there is little evidence supporting any specific treatment for these endocrine hair disorders in post-partum and postmenopausal women. Current hair treatment strategies are symptomatic and nonspecific so current researchers aim at developing new, targeted methods.

Insight in schizophrenia: a review.

PubMed

Dam, Jesper

2006-01-01

The issue of insight in schizophrenia must be assumed to be one of the most important aspects of the clinical examination. Comprehensive studies have shown that between 50% and 80% of all patients suffering from schizophrenia do not believe that they have a disorder. In recent years, poor insight in schizophrenia has been the subject of increasing interest, as manifested in a number of studies discussed in the present review. Some of these studies focus on insight correlated to various parameters such as psychopathology, neuropsychology, clinical relevance and compliance. Other studies refer to more theoretical implications, among these the issue of defining the concept of insight: whether insight can be seen as a "primary" phenomenon in schizophrenia, and whether insight may be graduated, dimensioned or increased. Several authors have developed rating scales in an attempt to obtain a measure for the degree or dimension of insight. Here, the range of parameters employed gives an excellent impression of the complexity of the concept of insight. In the concluding discussion, a phenomenological aspect is brought in, in an attempt to place the concept of insight in relation to disturbances of the self in schizophrenia and to primary symptoms in schizophrenia, amongst these autism.

Analysis - what is legal medicine?

PubMed

Beran, Roy G

2008-04-01

Legal medicine addresses the interface between medicine and law in health care. The Australian College of Legal Medicine (ACLM) established itself as the peak body in legal and forensic medicine in Australia. It helped establish the Expert Witness Institute of Australia (EWIA), the legal medicine programme at Griffith University and contributes to government enquiries. Public health, disability assessment, competing priorities of privacy verses notification and determination of fitness for a host of pursuits are aspects of legal medicine. Complementing the EWIA, the ACLM runs training programmes emphasising legal medicine skills additional to clinical practice, advocating clinical relevance. Assessment of athletes' fitness and ensuring that prohibited substances are not inadvertently prescribed represent a growing area of legal medicine. Ethical consideration of health care should respect legal medicine principles rather than armchair commentary. International conventions must be respected by legal medicine and dictate physicians' obligations. The NSW courts imposed a duty to provide emergency medical care. Migration and communicable diseases are aspects of legal medicine. Police surgeons provide a face to legal medicine (which incorporates forensic medicine) underpinning its public perception of specialty recognition. Legal medicine deserves its place as a medical specialty in its own right.

Culture, cultural factors and psychiatric diagnosis: review and projections.

PubMed

Alarcón, Renato D

2009-10-01

This paper aims to provide conceptual justifications for the inclusion of culture and cultural factors in psychiatric diagnosis, and logistic suggestions as to the content and use of this approach. A discussion of the scope and limitations of current diagnostic practice, criticisms from different quarters, and the role and relevance of culture in the diagnostic encounter, precede the examination of advantages and disadvantages of the approach. The cultural content of psychiatric diagnosis should include the main, well-recognized cultural variables, adequate family data, explanatory models, and strengths and weaknesses of every individual patient. The practical aspects include the acceptance of "cultural discordances" as a component of an updated definition of mental disorder, and the use of a refurbished cultural formulation. Clinical "telescoping" strategies to obtain relevant cultural data during the diagnostic interview, and areas of future research (including field trials on the cultural formulation and on "culture bound syndromes"), are outlined.

High throughput estimation of functional cell activities reveals disease mechanisms and predicts relevant clinical outcomes

PubMed Central

Hidalgo, Marta R.; Cubuk, Cankut; Amadoz, Alicia; Salavert, Francisco; Carbonell-Caballero, José; Dopazo, Joaquin

2017-01-01

Understanding the aspects of the cell functionality that account for disease or drug action mechanisms is a main challenge for precision medicine. Here we propose a new method that models cell signaling using biological knowledge on signal transduction. The method recodes individual gene expression values (and/or gene mutations) into accurate measurements of changes in the activity of signaling circuits, which ultimately constitute high-throughput estimations of cell functionalities caused by gene activity within the pathway. Moreover, such estimations can be obtained either at cohort-level, in case/control comparisons, or personalized for individual patients. The accuracy of the method is demonstrated in an extensive analysis involving 5640 patients from 12 different cancer types. Circuit activity measurements not only have a high diagnostic value but also can be related to relevant disease outcomes such as survival, and can be used to assess therapeutic interventions. PMID:28042959

Evidence based selection of probiotic strains to promote astronaut health or alleviate symptoms of illness on long duration spaceflight missions.

PubMed

Douglas, G L; Voorhies, A A

2017-10-13

Spaceflight impacts multiple aspects of human physiology, which will require non-invasive countermeasures as mission length and distance from Earth increases and the capability for external medical intervention decreases. Studies on Earth have shown that probiotics have the potential to improve some of the conditions that have manifested during spaceflight, such as gastrointestinal distress, dermatitis, and respiratory infections. The constraints and risks of spaceflight make it imperative that probiotics are carefully selected based on their strain-specific benefits, doses, delivery mechanisms, and relevance to likely crew conditions prior to evaluation in astronauts. This review focuses on probiotics that have been incorporated into healthy human gastrointestinal microbiomes and associated clinically with improvements in inflammatory state or alleviation of symptoms of crew-relevant illness. These studies provide an evidence base for probiotic selection with the greatest potential to support crew health and well-being in spaceflight.

The Oncopig Cancer Model: An Innovative Large Animal Translational Oncology Platform

PubMed Central

Schachtschneider, Kyle M.; Schwind, Regina M.; Newson, Jordan; Kinachtchouk, Nickolas; Rizko, Mark; Mendoza-Elias, Nasya; Grippo, Paul; Principe, Daniel R.; Park, Alex; Overgaard, Nana H.; Jungersen, Gregers; Garcia, Kelly D.; Maker, Ajay V.; Rund, Laurie A.; Ozer, Howard; Gaba, Ron C.; Schook, Lawrence B.

2017-01-01

Despite an improved understanding of cancer molecular biology, immune landscapes, and advancements in cytotoxic, biologic, and immunologic anti-cancer therapeutics, cancer remains a leading cause of death worldwide. More than 8.2 million deaths were attributed to cancer in 2012, and it is anticipated that cancer incidence will continue to rise, with 19.3 million cases expected by 2025. The development and investigation of new diagnostic modalities and innovative therapeutic tools is critical for reducing the global cancer burden. Toward this end, transitional animal models serve a crucial role in bridging the gap between fundamental diagnostic and therapeutic discoveries and human clinical trials. Such animal models offer insights into all aspects of the basic science-clinical translational cancer research continuum (screening, detection, oncogenesis, tumor biology, immunogenicity, therapeutics, and outcomes). To date, however, cancer research progress has been markedly hampered by lack of a genotypically, anatomically, and physiologically relevant large animal model. Without progressive cancer models, discoveries are hindered and cures are improbable. Herein, we describe a transgenic porcine model—the Oncopig Cancer Model (OCM)—as a next-generation large animal platform for the study of hematologic and solid tumor oncology. With mutations in key tumor suppressor and oncogenes, TP53R167H and KRASG12D, the OCM recapitulates transcriptional hallmarks of human disease while also exhibiting clinically relevant histologic and genotypic tumor phenotypes. Moreover, as obesity rates increase across the global population, cancer patients commonly present clinically with multiple comorbid conditions. Due to the effects of these comorbidities on patient management, therapeutic strategies, and clinical outcomes, an ideal animal model should develop cancer on the background of representative comorbid conditions (tumor macro- and microenvironments). As observed in clinical practice, liver cirrhosis frequently precedes development of primary liver cancer or hepatocellular carcinoma. The OCM has the capacity to develop tumors in combination with such relevant comorbidities. Furthermore, studies on the tumor microenvironment demonstrate similarities between OCM and human cancer genomic landscapes. This review highlights the potential of this and other large animal platforms as transitional models to bridge the gap between basic research and clinical practice. PMID:28879168

Systemic lupus erythematosus: Clinical and experimental aspects

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smolen, J.S.

1987-01-01

This text covers questions related to the history, etiology, pathogenesis, clinical aspects and therapy of systematic lupus erythematosus (SLE). Both animal models and human SLE are considered. With regard to basic science, concise information on cellular immunology, autoantibodies, viral aspects and molecular biology in SLE is provided. Clinical topics then deal with medical, dermatologic, neurologic, radiologic, pathologic, and therapeutic aspects. The book not only presents the most recent information on clinical and experimental insights, but also looks at future aspects related to the diagnosis and therapy of SLE.

The Dreyfus model of clinical problem-solving skills acquisition: a critical perspective

PubMed Central

Peña, Adolfo

2010-01-01

Context The Dreyfus model describes how individuals progress through various levels in their acquisition of skills and subsumes ideas with regard to how individuals learn. Such a model is being accepted almost without debate from physicians to explain the ‘acquisition’ of clinical skills. Objectives This paper reviews such a model, discusses several controversial points, clarifies what kind of knowledge the model is about, and examines its coherence in terms of problem-solving skills. Dreyfus' main idea that intuition is a major aspect of expertise is also discussed in some detail. Relevant scientific evidence from cognitive science, psychology, and neuroscience is reviewed to accomplish these aims. Conclusions Although the Dreyfus model may partially explain the ‘acquisition’ of some skills, it is debatable if it can explain the acquisition of clinical skills. The complex nature of clinical problem-solving skills and the rich interplay between the implicit and explicit forms of knowledge must be taken into consideration when we want to explain ‘acquisition’ of clinical skills. The idea that experts work from intuition, not from reason, should be evaluated carefully. PMID:20563279

A review of cognitive conflicts research: a meta-analytic study of prevalence and relation to symptoms

PubMed Central

Montesano, Adrián; López-González, María Angeles; Saúl, Luis Angel; Feixas, Guillem

2015-01-01

Recent research has highlighted the role of implicative dilemmas in a variety of clinical conditions. These dilemmas are a type of cognitive conflict, in which different aspects of the self are countered in such a way that a desired change in a personal dimension (eg, symptom improvement) may be hindered by the need of personal coherence in another dimension. The aim of this study was to summarize, using a meta-analytical approach, the evidence relating to the presence and the level of this conflict, as well as its relationship with well-being, in various clinical samples. A systematic review using multiple electronic databases found that out of 37 articles assessed for eligibility, nine fulfilled the inclusion criteria for meta-analysis. Random effects model was applied when computing mean effect sizes and testing for heterogeneity level. Statistically significant associations were observed between the clinical status and the presence of dilemmas, as well as level of conflict across several clinical conditions. Likewise, the level of conflict was associated with symptom severity. Results highlighted the clinical relevance and the transdiagnostic nature of implicative dilemmas. PMID:26675503

Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

PubMed

Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

2015-01-01

Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

Meth Mouth-A Growing Epidemic in Dentistry?

PubMed

Pabst, Andreas; Castillo-Duque, Juan Carlos; Mayer, Axel; Klinghuber, Marcus; Werkmeister, Richard

2017-10-30

In the past two decades, the synthetic style and fashion drug "crystal meth" ("crystal", "meth"), chemically representing the crystalline form of the methamphetamine hydrochloride, has become more and more popular in the United States, in Eastern Europe, and just recently in Central and Western Europe. "Meth" is cheap, easy to synthesize and to market, and has an extremely high potential for abuse and dependence. As a strong sympathomimetic, "meth" has the potency to switch off hunger, fatigue and, pain while simultaneously increasing physical and mental performance. The most relevant side effects are heart and circulatory complaints, severe psychotic attacks, personality changes, and progressive neurodegeneration. Another effect is "meth mouth", defined as serious tooth and oral health damage after long-standing "meth" abuse; this condition may become increasingly relevant in dentistry and oral- and maxillofacial surgery. There might be an association between general methamphetamine abuse and the development of osteonecrosis, similar to the medication-related osteonecrosis of the jaws (MRONJ). Several case reports concerning "meth" patients after tooth extractions or oral surgery have presented clinical pictures similar to MRONJ. This overview summarizes the most relevant aspect concerning "crystal meth" abuse and "meth mouth".

Palliative Care Bedside Teaching: A Qualitative Analysis of Medical Students' Reflective Writings after Clinical Practices.

PubMed

Rojí, Rocío; Noguera-Tejedor, Antonio; Pikabea-Díaz, Fernando; Carrasco, José Miguel; Centeno, Carlos

2017-02-01

A mandatory course in palliative care (PC) is organized for all final-year medical students at the University of Navarre. It consists of 24 lectures, 4 workshops, and 1 scheduled five hour clinical PC service experience at two different sites. In the 48 hours after the visit and related to the clinical experience, each student has to complete a 500-word reflective writing (RW) piece. To investigate how a brief PC clinical experience helps equip the medical student. Qualitative study of RW. Two researchers produced a content analysis of students' RW. They collaboratively developed themes and categories with a constant review of the classification tree and an exhaustive collection of quotes. Differences between services were analyzed (λ 2 ). One hundred sixty-seven RW were analyzed from the 197 students on the course (response rate 85%). Six major themes emerged: All the students identified central aspects of PC work dynamics; students acquired specific PC knowledge (86%); the personal influence of the experience was reported (68%); students described how patients and their caregivers deal with the patients' illness (68%); students talked about the essence of PC and essential aspects of medicine (42%); students reported spontaneously having changed their assumptions about PC (15%); and they realized that the experience was relevant to all clinical practice. Categories such as teamwork, the expression of patients' and caregivers' feelings, and family devotion showed statistical differences between services (λ 2 p < 0.05). A short bedside clinical experience in PC, encouraging student reflection, provides a deeper understanding of PC and even of core medicine values. The data we gather cannot explain only new skill acquisition but seems to suggest a life-changing personal experience for the student.

Big data - smart health strategies. Findings from the yearbook 2014 special theme.

PubMed

Koutkias, V; Thiessard, F

2014-08-15

To select best papers published in 2013 in the field of big data and smart health strategies, and summarize outstanding research efforts. A systematic search was performed using two major bibliographic databases for relevant journal papers. The references obtained were reviewed in a two-stage process, starting with a blinded review performed by the two section editors, and followed by a peer review process operated by external reviewers recognized as experts in the field. The complete review process selected four best papers, illustrating various aspects of the special theme, among them: (a) using large volumes of unstructured data and, specifically, clinical notes from Electronic Health Records (EHRs) for pharmacovigilance; (b) knowledge discovery via querying large volumes of complex (both structured and unstructured) biological data using big data technologies and relevant tools; (c) methodologies for applying cloud computing and big data technologies in the field of genomics, and (d) system architectures enabling high-performance access to and processing of large datasets extracted from EHRs. The potential of big data in biomedicine has been pinpointed in various viewpoint papers and editorials. The review of current scientific literature illustrated a variety of interesting methods and applications in the field, but still the promises exceed the current outcomes. As we are getting closer towards a solid foundation with respect to common understanding of relevant concepts and technical aspects, and the use of standardized technologies and tools, we can anticipate to reach the potential that big data offer for personalized medicine and smart health strategies in the near future.

EVALUATION OF THE HTA CORE MODEL FOR NATIONAL HEALTH TECHNOLOGY ASSESSMENT REPORTS: COMPARATIVE STUDY AND EXPERIENCES FROM EUROPEAN COUNTRIES.

PubMed

Kõrge, Kristina; Berndt, Nadine; Hohmann, Juergen; Romano, Florence; Hiligsmann, Mickael

2017-01-01

The health technology assessment (HTA) Core Model® is a tool for defining and standardizing the elements of HTA analyses within several domains for producing structured reports. This study explored the parallels between the Core Model and a national HTA report. Experiences from various European HTA agencies were also investigated to determine the Core Model's adaptability to national reports. A comparison between a national report on Genetic Counseling, produced by the Cellule d'expertise médicale Luxembourg, and the Core Model was performed to identify parallels in terms of relevant and comparable assessment elements (AEs). Semi-structured interviews with five representatives from European HTA agencies were performed to assess their user experiences with the Core Model. The comparative study revealed that 50 percent of the total number (n = 144) of AEs in the Core Model were relevant for the national report. Of these 144 AEs from the Core Model, 34 (24 percent) were covered in the national report. Some AEs were covered only partly. The interviewees emphasized flexibility in using the Core Model and stated that the most important aspects to be evaluated include characteristics of the disease and technology, clinical effectiveness, economic aspects, and safety. In the present study, the national report covered an acceptable number of AEs of the Core Model. These results need to be interpreted with caution because only one comparison was performed. The Core Model can be used in a flexible manner, applying only those elements that are relevant from the perspective of the technology assessment and specific country context.

Big Data - Smart Health Strategies

PubMed Central

2014-01-01

Summary Objectives To select best papers published in 2013 in the field of big data and smart health strategies, and summarize outstanding research efforts. Methods A systematic search was performed using two major bibliographic databases for relevant journal papers. The references obtained were reviewed in a two-stage process, starting with a blinded review performed by the two section editors, and followed by a peer review process operated by external reviewers recognized as experts in the field. Results The complete review process selected four best papers, illustrating various aspects of the special theme, among them: (a) using large volumes of unstructured data and, specifically, clinical notes from Electronic Health Records (EHRs) for pharmacovigilance; (b) knowledge discovery via querying large volumes of complex (both structured and unstructured) biological data using big data technologies and relevant tools; (c) methodologies for applying cloud computing and big data technologies in the field of genomics, and (d) system architectures enabling high-performance access to and processing of large datasets extracted from EHRs. Conclusions The potential of big data in biomedicine has been pinpointed in various viewpoint papers and editorials. The review of current scientific literature illustrated a variety of interesting methods and applications in the field, but still the promises exceed the current outcomes. As we are getting closer towards a solid foundation with respect to common understanding of relevant concepts and technical aspects, and the use of standardized technologies and tools, we can anticipate to reach the potential that big data offer for personalized medicine and smart health strategies in the near future. PMID:25123721

Technical and clinical view on ambulatory assessment in Parkinson's disease.

PubMed

Hobert, M A; Maetzler, W; Aminian, K; Chiari, L

2014-09-01

With the progress of technologies of recent years, methods have become available that use wearable sensors and ambulatory systems to measure aspects of--particular axial--motor function. As Parkinson's disease (PD) can be considered a model disorder for motor impairment, a significant number of studies have already been performed with these patients using such techniques. In general, motion sensors such as accelerometers and gyroscopes are used, in combination with lightweight electronics that do not interfere with normal human motion. A fundamental advantage in comparison with usual clinical assessment is that these sensors allow a more quantitative, objective, and reliable evaluation of symptoms; they have also significant advantages compared to in-lab technologies (e.g., optoelectronic motion capture) as they allow long-term monitoring under real-life conditions. In addition, based on recent findings particularly from studies using functional imaging, we learned that non-motor symptoms, specifically cognitive aspects, may be at least indirectly assessable. It is hypothesized that ambulatory quantitative assessment strategies will allow users, clinicians, and scientists in the future to gain more quantitative, unobtrusive, and everyday relevant data out of their clinical evaluation and can also be designed as pervasive (everywhere) and intensive (anytime) tools for ambulatory assessment and even rehabilitation of motor and (partly) non-motor symptoms in PD. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Idiopathic inflammatory myositis.

PubMed

Tieu, Joanna; Lundberg, Ingrid E; Limaye, Vidya

2016-02-01

Knowledge on idiopathic inflammatory myopathy (IIM) has evolved with the identification of myositis-associated and myositis-specific antibodies, development of histopathological classification and the recognition of how these correlate with clinical phenotype and response to therapy. In this paper, we outline key advances in diagnosis and histopathology, including the more recent identification of antibodies associated with immune-mediated necrotising myopathy (IMNM) and inclusion body myositis (IBM). Ongoing longitudinal observational cohorts allow further classification of these patients with IIM, their predicted clinical course and response to specific therapies. Registries have been developed worldwide for this purpose. A challenging aspect in IIM, a multisystem disease with multiple clinical subtypes, has been defining disease status and clinically relevant improvement. Tools for assessing activity and damage are now recognised to be important in determining disease activity and guiding therapeutic decision-making. The International Myositis Assessment and Clinical Studies (IMACS) group has developed such tools for use in research and clinical settings. There is limited evidence for specific treatment strategies in IIM. With significant development in the understanding of IIM and improved classification, longitudinal observational cohorts and trials using validated outcome measures are necessary, to provide important information for evidence-based care in the clinical setting. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Successful clinical and organisational change in endodontic practice: a qualitative study.

PubMed

Koch, M; Englander, M; Tegelberg, Å; Wolf, E

2014-08-01

The aim of this study was to explicate and describe the qualitative meaning of successful clinical and organizational change in endodontic practice, following a comprehensive implementation program, including the integration of the nickel-titanium-rotary-technique. After an educational intervention in the Public Dental Service in a Swedish county, thematic in-depth interviews were conducted, with special reference to the participants' experience of the successful change. Interviews with four participants, were purposively selected on the basis of occupation (dentist, dental assistant, receptionist, clinical manager), for a phenomenological human scientific analysis. Four constituents were identified as necessary for the invariant, general structure of the phenomenon: 1) disclosed motivation, 2) allowance for individual learning processes, 3) continuous professional collaboration, and 4) a facilitating educator. The perceived requirements for achieving successful clinical and organizational change in endodontic practice were clinical relevance, an atmosphere which facilitated discussion and allowance for individual learning patterns. The qualities required in the educator were acknowledged competence with respect to scientific knowledge and clinical expertise, as well as familiarity with conditions at the dental clinics. The results indicate a complex interelationship among various aspects of the successful change process. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Current state of ethics literature synthesis: a systematic review of reviews.

PubMed

Mertz, Marcel; Kahrass, Hannes; Strech, Daniel

2016-10-03

Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed. A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature. We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information. While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.

Research training in integrative medicine: how can we make teaching and learning in research methods more sustainable and engaging?

PubMed

Witt, Claudia M; Withers, Shelly Rafferty

2013-01-01

The aim of this project was to identify strategies for increasing learner engagement and knowledge retention in clinical research training of complementary and integrative medicine (CIM) practitioners, and to offer a conceptual framework to address clinical research training for CIM practitioners. In a featured large-group discussion (15min presentation and 30min discussion), two questions (strategies that are recommended to overcome these barriers; relevant aspects for a framework for building sustainable knowledge) were put to the audience. The sample consisted of 43 participants at the International Congress of Educators in Complementary and Alternative Medicine, in Washington, DC, in October 2012. The featured discussion was moderated and detailed notes were taken. Notes were synthesized and discussed by both authors until consensus was reached. Based on the results from the featured discussion session and a focused literature search, a framework for building sustainable knowledge and skills in clinical research for CIM practitioners was developed. Participants' responses to the questions of engagement and sustainability included curricular structures, pedagogical strategies for instruction, the use of digital tools to extend the learning experience, the necessity to ground instruction firmly in the medical literature of the field, and the relevance of mentoring. Key considerations for building sustainable knowledge in clinical research for CIM practitioners are as follows: (1) prioritizing clinical research training, (2) issues of curriculum and pedagogy, (3) technology/digital tools, (4) administrative challenges, (5) supporting the formation of communities of practice, and (6) cultural perspectives of CIM practitioners. © 2013 Elsevier Inc. All rights reserved.

Towards Prevention of Breast Cancer: What Are the Clinical Challenges?

PubMed

Borgquist, Signe; Hall, Per; Lipkus, Isaac; Garber, Judy E

2018-05-01

The dramatic increase in breast cancer incidence compels a paradigm shift in our preventive efforts. There are several barriers to overcome before prevention becomes an established part of breast cancer management. The objective of this review is to identify the clinical challenges for improved breast cancer prevention and discuss current knowledge on breast cancer risk assessment methods, risk communication, ethics, and interventional efforts with the aim of covering the aspects relevant for a breast cancer prevention trial. Herein, the following five areas are discussed: (i) Adequate tools for identification of women at high risk of breast cancer suggestively entitled Prevent! Online. (ii) Consensus on the definition of high risk, which is regarded as mandatory for all risk communication and potential prophylactic interventions. (iii) Risk perception and communication regarding risk information. (iv) Potential ethical concerns relevant for future breast cancer prevention programs. (v) Risk-reducing programs involving multileveled prevention depending on identified risk. Taken together, devoted efforts from both policy makers and health care providers are warranted to improve risk assessment and risk counseling in women at risk for breast cancer to optimize the prevention of breast cancer. Cancer Prev Res; 11(5); 255-64. ©2018 AACR . ©2018 American Association for Cancer Research.

A report on older-age bipolar disorder from the International Society for Bipolar Disorders Task Force.

PubMed

Sajatovic, Martha; Strejilevich, Sergio A; Gildengers, Ariel G; Dols, Annemiek; Al Jurdi, Rayan K; Forester, Brent P; Kessing, Lars Vedel; Beyer, John; Manes, Facundo; Rej, Soham; Rosa, Adriane R; Schouws, Sigfried Ntm; Tsai, Shang-Ying; Young, Robert C; Shulman, Kenneth I

2015-11-01

In the coming generation, older adults with bipolar disorder (BD) will increase in absolute numbers as well as proportion of the general population. This is the first report of the International Society for Bipolar Disorder (ISBD) Task Force on Older-Age Bipolar Disorder (OABD). This task force report addresses the unique aspects of OABD including epidemiology and clinical features, neuropathology and biomarkers, physical health, cognition, and care approaches. The report describes an expert consensus summary on OABD that is intended to advance the care of patients, and shed light on issues of relevance to BD research across the lifespan. Although there is still a dearth of research and health efforts focused on older adults with BD, emerging data have brought some answers, innovative questions, and novel perspectives related to the notion of late onset, medical comorbidity, and the vexing issue of cognitive impairment and decline. Improving our understanding of the biological, clinical, and social underpinnings relevant to OABD is an indispensable step in building a complete map of BD across the lifespan. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Novel approaches and perspectives in allergen immunotherapy.

PubMed

Hoffmann, H J; Valovirta, E; Pfaar, O; Moingeon, P; Schmid, J M; Skaarup, S H; Cardell, L-O; Simonsen, K; Larché, M; Durham, S R; Sørensen, P

2017-07-01

In this review, we report on relevant current topics in allergen immunotherapy (AIT) which were broadly discussed during the first Aarhus Immunotherapy Symposium (Aarhus, Denmark) in December 2015 by leading clinicians, scientists and industry representatives in the field. The aim of this symposium was to highlight AIT-related aspects of public health, clinical efficacy evaluation, mechanisms, development of new biomarkers and an overview of novel therapeutic approaches. Allergy is a public health issue of high socioeconomic relevance, and development of evidence-based action plans to address allergy as a public health issue ought to be on national and regional agendas. The underlying mechanisms are in the focus of current research that lays the ground for innovative therapies. Standardization and harmonization of clinical endpoints in AIT trials as well as current knowledge about potential biomarkers have substantiated proof of effectiveness of this disease-modifying therapeutic option. Novel treatments such as peptide immunotherapy, intralymphatic immunotherapy and use of recombinant allergens herald a new age in which AIT may address treatment of allergy as a public health issue by reaching a large fraction of patients. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Factors associated with multidimensional aspect of post-stroke fatigue in acute stroke period.

PubMed

Mutai, Hitoshi; Furukawa, Tomomi; Houri, Ayumi; Suzuki, Akihito; Hanihara, Tokiji

2017-04-01

Post-stroke fatigue (PSF) is a frequent and distressing consequence of stroke, and can be both acute and long lasting. We aimed to investigate multidimensional aspects of acute PSF and to determine the clinical factors relevant to acute PSF. We collected data of 101 patients admitted to the hospital for acute stroke. PSF was assessed using the Multidimensional Fatigue Inventory within 2 weeks of stroke. Measures included Mini-Mental State Examination, Hospital Anxiety and Depression Scale, and Functional Independence Measure. Stroke character, lesion location, and clinical variables that potentially influence PSF were also collected. The prevalence of pathological fatigue is 56.4% within 2 weeks of stroke. Binary logistic regression analysis revealed that anxiety was the only predictor for presence of PSF (OR=1.32, 95% CI: 1.13-1.53, P<0.001). Multivariate stepwise regression analysis showed anxiety, right lesion side, thalamus, and/or brainstem were independently associated with general fatigue, right lesion side, depression, diabetes mellitus, and anxiety with physical fatigue, depression with reduced activity, depression, and BMI with reduced motivation, depression, and diabetes mellitus with mental fatigue. PSF was highly prevalent in the acute phase, and specific factors including lesion location (right side lesion, thalamic and brainstem lesion), anxiety, and depression were independently associated with multidimensional aspects of PSF. Further study is needed to elucidate how specific structural lesions and anxiety symptoms relate to the development of early fatigue following stroke. Copyright © 2016 Elsevier B.V. All rights reserved.

Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study.

PubMed

Turnbull, Alison E; Sepulveda, Kristin A; Dinglas, Victor D; Chessare, Caroline M; Bingham, Clifton O; Needham, Dale M

2017-06-01

To identify the "core domains" (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stakeholders agree are essential to assess in all clinical research studies evaluating the outcomes of acute respiratory failure survivors after hospital discharge. A two-round consensus process, using a modified Delphi methodology, with participants from 16 countries, including patient and caregiver representatives. Prior to voting, participants were asked to review 1) results from surveys of clinical researchers, acute respiratory failure survivors, and caregivers that rated the importance of 19 preliminary outcome domains and 2) results from a qualitative study of acute respiratory failure survivors' outcomes after hospital discharge, as related to the 19 preliminary outcome domains. Participants also were asked to suggest any additional potential domains for evaluation in the first Delphi survey. Web-based surveys of participants representing four stakeholder groups relevant to clinical research evaluating postdischarge outcomes of acute respiratory failure survivors: clinical researchers, clinicians, patients and caregivers, and U.S. federal research funding organizations. None. None. Survey response rates were 97% and 99% in round 1 and round 2, respectively. There were seven domains that met the a priori consensus criteria to be designated as core domains: physical function, cognition, mental health, survival, pulmonary function, pain, and muscle and/or nerve function. This study generated a consensus-based list of core domains that should be assessed in all clinical research studies evaluating acute respiratory failure survivors after hospital discharge. Identifying appropriate measurement instruments to assess these core domains is an important next step toward developing a set of core outcome measures for this field of research.

Conservation physiology across scales: insights from the marine realm

PubMed Central

Cooke, Steven J.; Killen, Shaun S.; Metcalfe, Julian D.; McKenzie, David J.; Mouillot, David; Jørgensen, Christian; Peck, Myron A.

2014-01-01

As the field of conservation physiology develops and becomes increasingly integrated with ecology and conservation science, the fundamental concept of scale is being recognized as important, particularly for ensuring that physiological knowledge is contextualized in a manner most relevant to policy makers, conservation practitioners and stakeholders. Failure to consider the importance of scale in conservation physiology—both the challenges and the opportunities that it creates—will impede the ability of this discipline to generate the scientific understanding needed to contribute to meaningful conservation outcomes. Here, we have focused on five aspects of scale: biological, spatial, temporal, allometric and phylogenetic. We also considered the scale of policy and policy application relevant to those five types of scale as well as the merits of upscaling and downscaling to explore and address conservation problems. Although relevant to all systems (e.g. freshwater, terrestrial) we have used examples from the marine realm, with a particular emphasis on fishes, given the fact that there is existing discourse regarding scale and its relevance for marine conservation and management. Our synthesis revealed that all five aspects of scale are relevant to conservation physiology, with many aspects inherently linked. It is apparent that there are both opportunities and challenges afforded by working across scales but, to understand mechanisms underlying conservation problems, it is essential to consider scale of all sorts and to work across scales to the greatest extent possible. Moreover, given that the scales in biological processes will often not match policy and management scales, conservation physiology needs to show how it is relevant to aspects at different policy/management scales, change the scales at which policy/management intervention is applied or be prepared to be ignored. PMID:27293645

Year in review 2005: Critical Care – nephrology

PubMed Central

Ricci, Zaccaria; Ronco, Claudio

2006-01-01

We summarize original research in the field of critical care nephrology accepted or published in 2005 in Critical Care and, when considered relevant or directly linked to this research, in other journals. The articles have been grouped into four categories to facilitate a rapid overview. First, physiopathology, epidemiology and prognosis of acute renal failure (ARF): an extensive review and some observational studies have been performed with the aim of describing aspects of ARF physiopathology, precise epidemiology and long-term outcomes. Second, several authors have performed clinical trials utilizing a potential nephro-protective drug, fenoldopam, with different results. Third, the issue of continuous renal replacement therapies dose has been addressed in a small prospective study and a large observational trial. And fourth, alternative indications to extracorporeal treatment of ARF and systemic inflammatory response syndrome have been explored by three original clinical studies. PMID:16919174

Creative Learning Identities

ERIC Educational Resources Information Center

Jeffrey, Bob

2008-01-01

Making learning relevant involves many aspects of teaching such as attention to levels of maturity, individual inclinations, emotional, physical, aesthetic and cognitive activity and group dynamics. However, making learning relevant is not only a teacher led activity, for learners make activities relevant by the identification of connections with…

Patient's Perspective on Quality of Teleconsultation Services.

PubMed

Thijssing, Leonie; Tensen, Esmée; Jaspers, Monique

2016-01-01

Patient satisfaction with teleconsultation services can increase their acceptance. Validated and standardized questionnaires to measure the quality aspects of teleconsultation relevant from the patients' perspective are not available yet. We aim to develop such a questionnaire. First, a systematic literature search was performed and focus groups were held to acquire quality aspects of teleconsultations patients perceive as important. Thirty-seven unique quality aspects distilled from these activities, were used for questionnaire development based on the framework of the Consumer Quality Index. In future research, the comprehensiveness, relevance and unambiguousness of the concept questionnaire need to be tested and the reliability and internal cohesion of the questionnaire assessed.

Tendon Tissue Engineering: Progress, Challenges, and Translation to the Clinic

PubMed Central

Shearn, Jason T.; Kinneberg, Kirsten R.C.; Dyment, Nathaniel A.; Galloway, Marc T.; Kenter, Keith; Wylie, Christopher; Butler, David L.

2013-01-01

The tissue engineering field has made great strides in understanding how different aspects of tissue engineered constructs (TECs) and the culture process affect final tendon repair. However, there remain significant challenges in developing strategies that will lead to a clinically effective and commercially successful product. In an effort to increase repair quality, a better understanding of normal development, and how it differs from adult tendon healing, may provide strategies to improve tissue engineering. As tendon tissue engineering continues to improve, the field needs to employ more clinically relevant models of tendon injury such as degenerative tendons. We need to translate successes to larger animal models to begin exploring the clinical implications of our treatments. By advancing the models used to validate our TECs, we can help convince our toughest customer, the surgeon, that our products will be clinically efficacious. As we address these challenges in musculoskeletal tissue engineering, the field still needs to address the commercialization of products developed in the laboratory. TEC commercialization faces numerous challenges because each injury and patient is unique. This review aims to provide tissue engineers with a summary of important issues related to engineering tendon repairs and potential strategies for producing clinically successful products. PMID:21625053

Cryopreservation and Revival of Human Mesenchymal Stromal Cells.

PubMed

Haack-Sørensen, Mandana; Ekblond, Annette; Kastrup, Jens

2016-01-01

Cell-based therapy is a promising and innovative new treatment for different degenerative and autoimmune diseases, and mesenchymal stromal cells (MSCs) from the bone marrow have demonstrated great therapeutic potential due to their immunosuppressive and regenerative capacities.The establishment of methods for large-scale expansion of clinical-grade MSCs in vitro has paved the way for their therapeutic use in clinical trials. However, the clinical application of MSCs also requires cryopreservation and banking of the cell products. To preserve autologous or allogeneic MSCs for future clinical applications, a reliable and effective cryopreservation method is required.Developing a successful cryopreservation protocol for clinical stem cell products, cryopreservation media, cryoprotectant agents (CPAs), the freezing container, the freezing temperature, and the cooling and warming rate are all aspects which should be considered.A major challenge is the selection of a suitable cryoprotectant which is able to penetrate the cells and yet has low toxicity.This chapter focuses on recent technological developments relevant for the cryopreservation of MSCs using the most commonly used cryopreservation medium containing DMSO and animal serum or human-derived products for research use and the animal protein-free cryopreservation media CryoStor (BioLife Solutions) for clinical use.

Incorporating Pharmacogenomics into Health Information Technology, Electronic Health Record and Decision Support System: An Overview.

PubMed

Alanazi, Abdullah

2017-02-01

As the adoption of information technology in healthcare is rising, the potentiality of moving Pharmacogenomics from benchside to bedside is aggravated. This paper reviews the current status of Pharmacogenomics (PGx) information and the attempts for incorporating them into the Electronic Health Record (EHR) system through Decision Support Systems (DSSs). Rigorous review strategies of PGx information and providing context-relevant recommendations in form of action plan- dose adjustment, lab tests rather than just information- would be ideal for making clinical recommendations out of PGx information. Lastly, realistic projections of what pharmacogenomics can provide is another important aspect in incorporating Pharmacogenomics into health information technology.

Infection of the endothelium by members of the order Rickettsiales

PubMed Central

Valbuena, Gustavo; Walker, David H.

2010-01-01

Summary The vascular endothelium is the main target of a limited number of infectious agents; Rickettsia, Ehrlichia ruminantium, and Orientia tsutsugamushi are among them. These arthropod-transmitted obligately-intracellular bacteria cause serious systemic diseases that are not infrequently lethal. In this review, we discuss the bacterial biology, vector biology, and clinical aspects of these conditions with particular emphasis on the interactions of these bacteria with the vascular endothelium and how it responds to intracellular infection. The study of these bacteria in relevant in vivo models is likely to offer new insights into the physiology of the endothelium that have not been revealed by other models. PMID:19967137

[Insufficient evidence supporting iron supplementation in anaemia during pregnancy].

PubMed

Wiegerinck, Melanie M; Mol, Ben Willem J

2012-01-01

The Royal Dutch Organization of Midwives (KNOV) recently presented their practice guideline 'Anaemia in midwifery practice'. The guideline identified available evidence on diagnosis, prognosis and treatment of anaemia in pregnancy. Anaemia based on iron deficiency and subsequent treatment with iron supplementation are probably the most frequent aspects of care for pregnant women. However, there is surprisingly enough no evidence of the efficacy of iron supplementation treatment on relevant clinical outcomes in pregnant women with anaemia. We plead to make the next guideline a multidisciplinary one. Such a guideline may lead to a large pragmatic trial evaluating the efficacy of iron supplementation treatment for patients with anaemia.

Teaching Psychology: The Political Context

ERIC Educational Resources Information Center

Newland, John

2008-01-01

In this commentary, the author raises two critical aspects not adequately addressed in John Radford's (2008) wide ranging article on the teaching of psychology in higher education. The first aspect is the relevance of boundaries. The second aspect is the political context(s). These two issues, though artificially dissociated for current purposes,…

The default network and self-generated thought: component processes, dynamic control, and clinical relevance

PubMed Central

Andrews-Hanna, Jessica R.; Smallwood, Jonathan; Spreng, R. Nathan

2014-01-01

Though only a decade has elapsed since the default network was first emphasized as being a large-scale brain system, recent years have brought great insight into the network’s adaptive functions. A growing theme highlights the default network as playing a key role in internally-directed—or self-generated—thought. Here, we synthesize recent findings from cognitive science, neuroscience, and clinical psychology to focus attention on two emerging topics as current and future directions surrounding the default network. First, we present evidence that self-generated thought is a multi-faceted construct whose component processes are supported by different subsystems within the network. Second, we highlight the dynamic nature of the default network, emphasizing its interaction with executive control systems when regulating aspects of internal thought. We conclude by discussing clinical implications of disruptions to the integrity of the network, and consider disorders when thought content becomes polarized or network interactions become disrupted or imbalanced. PMID:24502540

Molecular Mechanisms Underlying Occult Hepatitis B Virus Infection

PubMed Central

Samal, Jasmine; Kandpal, Manish

2012-01-01

Summary: Chronic hepatitis B virus (HBV) infection is a complex clinical entity frequently associated with cirrhosis and hepatocellular carcinoma (HCC). The persistence of HBV genomes in the absence of detectable surface antigenemia is termed occult HBV infection. Mutations in the surface gene rendering HBsAg undetectable by commercial assays and inhibition of HBV by suppression of viral replication and viral proteins represent two fundamentally different mechanisms that lead to occult HBV infections. The molecular mechanisms underlying occult HBV infections, including recently identified mechanisms associated with the suppression of HBV replication and inhibition of HBV proteins, are reviewed in detail. The availability of highly sensitive molecular methods has led to increased detection of occult HBV infections in various clinical settings. The clinical relevance of occult HBV infection and the utility of appropriate diagnostic methods to detect occult HBV infection are discussed. The need for specific guidelines on the diagnosis and management of occult HBV infection is being increasingly recognized; the aspects of mechanistic studies that warrant further investigation are discussed in the final section. PMID:22232374

A guide to benzodiazepine selection. Part II: Clinical aspects.

PubMed

Teboul, E; Chouinard, G

1991-02-01

To suit the specific needs of various clinical situations, selection of an appropriate benzodiazepine derivative should be based on consideration of their different pharmacokinetic and pharmacodynamic properties. Benzodiazepine derivatives that are rapidly eliminated produce the most pronounced rebound and withdrawal syndromes. Benzodiazepines that are slowly absorbed and slowly eliminated are most appropriate for the anxious patient, since these derivatives produce a gradual and sustained anxiolytic effect. Rapidly absorbed and slowly eliminated benzodiazepines are usually more appropriate for patients with sleep disturbances, since the rapid absorption induces sleep and the slower elimination rate may induce less tolerance to the sedative effect. Rational selection of a benzodiazepine for the elderly and for the suspected drug abuser is more problematic. The relevant pharmacokinetic and clinical considerations for these users are discussed. Certain derivatives may possess pharmacodynamic properties not shared by the entire benzodiazepine class; empirical studies have suggested the existence of anti-panic properties for alprazolam and clonazepam, antidepressant properties for alprazolam, and anti-manic properties for clonazepam and possibly lorazepam.

Clinical relevance of epigenetics in the onset and management of type 2 diabetes mellitus

PubMed Central

Sommese, Linda; Zullo, Alberto; Mancini, Francesco Paolo; Fabbricini, Rossella; Soricelli, Andrea; Napoli, Claudio

2017-01-01

ABSTRACT Epigenetics is involved in the altered expression of gene networks that underlie insulin resistance and insufficiency. Major genes controlling β-cell differentiation and function, such as PAX4, PDX1, and GLP1 receptor, are epigenetically controlled. Epigenetics can cause insulin resistance through immunomediated pro-inflammatory actions related to several factors, such as NF-kB, osteopontin, and Toll-like receptors. Hereafter, we provide a critical and comprehensive summary on this topic with a particular emphasis on translational and clinical aspects. We discuss the effect of epigenetics on β-cell regeneration for cell replacement therapy, the emerging bioinformatics approaches for analyzing the epigenetic contribution to type 2 diabetes mellitus (T2DM), the epigenetic core of the transgenerational inheritance hypothesis in T2DM, and the epigenetic clinical trials on T2DM. Therefore, prevention or reversion of the epigenetic changes occurring during T2DM development may reduce the individual and societal burden of the disease. PMID:28059593

A Quantitative Proteomics Approach to Clinical Research with Non-Traditional Samples

PubMed Central

Licier, Rígel; Miranda, Eric; Serrano, Horacio

2016-01-01

The proper handling of samples to be analyzed by mass spectrometry (MS) can guarantee excellent results and a greater depth of analysis when working in quantitative proteomics. This is critical when trying to assess non-traditional sources such as ear wax, saliva, vitreous humor, aqueous humor, tears, nipple aspirate fluid, breast milk/colostrum, cervical-vaginal fluid, nasal secretions, bronco-alveolar lavage fluid, and stools. We intend to provide the investigator with relevant aspects of quantitative proteomics and to recognize the most recent clinical research work conducted with atypical samples and analyzed by quantitative proteomics. Having as reference the most recent and different approaches used with non-traditional sources allows us to compare new strategies in the development of novel experimental models. On the other hand, these references help us to contribute significantly to the understanding of the proportions of proteins in different proteomes of clinical interest and may lead to potential advances in the emerging field of precision medicine. PMID:28248241

A Quantitative Proteomics Approach to Clinical Research with Non-Traditional Samples.

PubMed

Licier, Rígel; Miranda, Eric; Serrano, Horacio

2016-10-17

The proper handling of samples to be analyzed by mass spectrometry (MS) can guarantee excellent results and a greater depth of analysis when working in quantitative proteomics. This is critical when trying to assess non-traditional sources such as ear wax, saliva, vitreous humor, aqueous humor, tears, nipple aspirate fluid, breast milk/colostrum, cervical-vaginal fluid, nasal secretions, bronco-alveolar lavage fluid, and stools. We intend to provide the investigator with relevant aspects of quantitative proteomics and to recognize the most recent clinical research work conducted with atypical samples and analyzed by quantitative proteomics. Having as reference the most recent and different approaches used with non-traditional sources allows us to compare new strategies in the development of novel experimental models. On the other hand, these references help us to contribute significantly to the understanding of the proportions of proteins in different proteomes of clinical interest and may lead to potential advances in the emerging field of precision medicine.

Breech presentation: an audit project as means of pursuing clinical excellence.

PubMed

Siassakos, D; Anderson, H; Panter, K

2005-10-01

Clinical audit is an effective quality improvement process to evaluate important clinical issues. Breech presentation is such an issue due to its contribution to the rising caesarean section (CS) rate. We set out to assess the management of breech presentation using, as standards, the delivery suite protocol and national guidelines. Our first audit revealed a low success rate of external cephalic version (ECV) and deficient documentation of written consent for ECV, other aspects of care being satisfactory. The results were presented to a multidisciplinary meeting and disseminated to relevant stakeholders. A re-audit was then performed. It confirmed significant improvement in the documentation of consent for ECV. It also revealed a good detection rate of breech, optimal offer rate of ECV and good neonatal outcome. However, uptake of ECV as well as the success rate could both be improved so as to reduce the CS rate for breech presentation. We discuss options for improving the uptake and success rate for ECV.

Evolving paradigms in multifocal breast cancer.

PubMed

Salgado, Roberto; Aftimos, Philippe; Sotiriou, Christos; Desmedt, Christine

2015-04-01

The 7th edition of the TNM defines multifocal breast cancer as multiple simultaneous ipsilateral and synchronous breast cancer lesions, provided they are macroscopically distinct and measurable using current traditional pathological and clinical tools. According to the College of American Pathologists (CAP), the characterization of only the largest lesion is considered sufficient, unless the grade and/or histology are different between the lesions. Here, we review three potentially clinically relevant aspects of multifocal breast cancers: first, the importance of a different intrinsic breast cancer subtype of the various lesions; second, the emerging awareness of inter-lesion heterogeneity; and last but not least, the potential introduction of bias in clinical trials due to the unrecognized biological diversity of these cancers. Although the current strategy to assess the lesion with the largest diameter has clearly its advantages in terms of costs and feasibility, this recommendation may not be sustainable in time and might need to be adapted to be compliant with new evolving paradigms in breast cancer. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Journal of Allergy and Clinical Immunology: In Practice - 2016 Year in Review.

PubMed

Schatz, Michael; Sicherer, Scott H; Zeiger, Robert S

As editors, we concluded that it would be helpful to our readers to write a Year in Review article that highlights the Review, Original, and Clinical Communication articles published in 2016 in The Journal of Allergy and Clinical Immunology: In Practice. We summarized articles on the topics of asthma, rhinitis/rhinosinusitis, food allergy, anaphylaxis, drug allergy, urticarial/angioedema, eosinophilic disorders, and immunodeficiency. Within each topic, epidemiologic findings are presented, relevant aspects of prevention are described, and diagnostic and therapeutic advances are enumerated. Diagnostic tools described include history, skin tests, and in vitro tests. Treatments discussed include behavioral therapy, allergen avoidance therapy, positive and negative effects of pharmacologic therapy, and various forms of immunologic and desensitization management. We hope this review will help you, our readers, consolidate and use this extensive and practical knowledge for the benefit of your patients. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Important factors to consider when treating children with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): perspectives of health professionals from specialist services.

PubMed

Parslow, Roxanne M; Shaw, Alison; Haywood, Kirstie L; Crawley, Esther

2017-02-01

Paediatric Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) is relatively common and disabling. Improving treatment requires the development of Patient Reported Outcome Measures (PROMs) that enable clinicians and researchers to collect patient-centred evidence on outcomes. Health professionals are well placed to provide clinical insight into the condition, its treatment and possible outcomes. This study aimed to understand the perspectives of specialist paediatric CFS/ME health professionals and identify outcomes that are clinically important. Focus groups and interviews were held with 15 health professionals involved in the care of children with CFS/ME from the four largest specialist paediatric CFS/ME services in the NHS in England. A range of clinical disciplines were included and experience in paediatric CFS/ME ranged from 2 months to 25 years. Ten participants (67%) were female. Focus groups and interviews were recorded, transcribed verbatim and data were analysed using thematic analysis. All health professionals identified the impact of CFS/ME across multiple aspects of health. Health professionals described four areas used to assess the severity of the illness and outcome in children: 1) symptoms; 2) physical function; 3) participation (school, activities and social life); and 4) emotional wellbeing. They also described the complexity of the condition, contextual factors and considerations for treatment to help children to cope with the condition. Clinically important outcomes in paediatric CFS/ME involve a range of aspects of health. Health professionals consider increases in physical function yet maintaining school functioning and participation more widely as important outcomes from treatment. The results are similar to those described by children in a recent study and will be combined to develop a new child-specific PROM that has strong clinical utility and patient relevance.

The ethical framework for performing research with rare inherited neurometabolic disease patients.

PubMed

Giannuzzi, Viviana; Devlieger, Hugo; Margari, Lucia; Odlind, Viveca Lena; Ragab, Lamis; Bellettato, Cinzia Maria; D'Avanzo, Francesca; Lampe, Christina; Cassis, Linda; Cortès-Saladelafont, Elisenda; Cazorla, Ángels Garcia; Barić, Ivo; Cvitanović-Šojat, Ljerka; Fumić, Ksenija; Dali, Christine I; Bartoloni, Franco; Bonifazi, Fedele; Scarpa, Maurizio; Ceci, Adriana

2017-03-01

The need for performing clinical trials to develop well-studied and appropriate medicines for inherited neurometabolic disease patients faces ethical concerns mainly raising from four aspects: the diseases are rare; include young and very young patients; the neurological impairment may compromise the capability to provide 'consent'; and the genetic nature of the disease leads to further ethical implications. This work is intended to identify the ethical provisions applicable to clinical research involving these patients and to evaluate if these cover the ethical issues. Three searches have been performed on the European regulatory/legal framework, the literature and European Union-funded projects. The European legal framework offers a number of ethical provisions ruling the clinical research on paediatric, rare, inherited diseases with neurological symptoms. In the literature, relevant publications deal with informed consent, newborn genetic screenings, gene therapy and rights/interests of research participants. Additional information raised from European projects on sharing patients' data from different countries, the need to fill the gap of the regulatory framework and to improve information to stakeholders and patients/families. Several recommendations and guidelines on ethical aspects are applicable to the inherited neurometabolic disease research in Europe, even though they suffer from the lack of a common ethical approach. What is Known: • When planning and conducting clinical trials, sponsors and researchers know that clinical trials are to be performed according to well-established ethical rules, and patients should be aware about their rights. • In the cases of paediatric patients, vulnerable patients unable to provide consent, genetic diseases' further rules apply. What is New: • This work discusses which ethical rules apply to ensure protection of patient's rights if all the above-mentioned features coexist. • This work shows available data and information on how these rules have been applied.

Clinical relevance in anesthesia journals.

PubMed

Lauritsen, Jakob; Møller, Ann M

2006-04-01

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. In the last few years, more attention has been paid to evidence-based medicine in anesthesia. Several articles on the subject have focused on the need to base clinical decisions on sound research employing both methodological rigor and clinically relevant outcomes. The number of systematic reviews in anesthesia literature is increasing as well as the focus on diminishing the number of surrogate outcomes. It has been shown that the impact factor is not a valid measure of establishing the level of clinical relevance to a journal. This review presents definitions of clinically relevant anesthesia articles. A clinically relevant article employs both methodological rigor and a clinically relevant outcome. The terms methodological rigor and clinical outcomes are fully discussed in the review as well as problems with journal impact factors.

Teaching and learning in undergraduate anaesthesia: a quantitative and qualitative analysis of practice at the University of Auckland.

PubMed

Sidhu, N S; Weller, J M; Mitchell, S J

2015-11-01

Anaesthesia encompasses a broad range of knowledge and skills of relevance to graduating doctors. For the majority of new doctors, an undergraduate clinical rotation is their only exposure to anaesthesia practice. However, the content and approach to undergraduate anaesthesia education varies between institutions. We explored our students' views and experiences, and teaching approaches and expectations of consultant anaesthetists during a clinical attachment in anaesthesia. Our mixed-method design included student and staff surveys, logbook analysis and student focus groups. Logbook analysis of all 202 students showed mean numbers of attempts for bag-mask ventilation, laryngeal mask insertion, tracheal intubation and IV cannulation were 6.8, 3.9, 3.3 and 4.5, respectively. Focus group responses (11 students, three groups) suggested a mismatch between students' expectations of performing clinical skills and the available opportunities, particularly for IV cannulation. Students often felt reluctant to ask anaesthetists to teach them, and appreciated clinician-led engagement in all aspects of learning patient management. Among the 78 anaesthetists (29.3%) responding to the survey, the five tasks most frequently identified as suitable for teaching to students all related to airway management. Our study found much unanticipated variability in student exposure, teaching practice and attitudes to teaching various skills or procedures between anaesthetists, and student opinion of their clinical attachment. The findings resulted in a review of many aspects of the attachment. It is likely that other institutions will have similar variability and we recommend they undertake similar exercises to optimise teaching and learning opportunities for undergraduate anaesthesia.

Educational priorities and current involvement in genetic practice: a survey of midwives in the Netherlands, UK and Sweden.

PubMed

Benjamin, Caroline M; Anionwu, Elizabeth N; Kristoffersson, Ulf; ten Kate, Leo P; Plass, Anne Marie C; Nippert, Irmgard; Julian-Reynier, Claire; Harris, Hilary J; Schmidtke, Joerg; Challen, Kirsty; Calefato, Jean Marc; Waterman, Christine; Powell, Eileen; Harris, Rodney

2009-10-01

to investigate whether practising midwives are adequately prepared to integrate genetic information into their practice. a cross-sectional, postal, structured questionnaire survey was sent to practising midwives. practising midwives from the Netherlands (NL), Sweden (SE) and the United Kingdom (UK). 1021 replies were received, achieving a response rate of 62%. 79% (799/1015) of midwives reported attending courses with some 'genetic content' during their initial training. Sixty-eight per cent (533/784) judged this to have been useful for clinical practice. Variation was seen between countries in the amount of genetic content in post-registration training (SE 87%, NL 44%, UK 17%) and most was considered useful. Questions assessing clinical activity identified a current need for genetic knowledge. Midwives described low levels of self-reported confidence both in overtly genetic procedures and in everyday tasks that were underpinned by genetic knowledge. For eight of the 12 procedures, fewer than 20% of midwives considered themselves to be confident. Differences were apparent between countries. Midwives identified psychosocial, screening and risk assessment aspects of genetic education as being important to them, rather than technical aspects or genetic science. given the low reported confidence with genetic issues in clinical practice, it is essential that this is addressed in terms of the amount, content and targeting of genetic education. This is especially important to ensure the success of national antenatal and baby screening programmes. The results of this study suggest that midwives would welcome further training in genetics, addressing genetic topics most relevant to their clinical practice.

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

PubMed

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

2013-01-01

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

[Non-AIDS-associated cancer disorders. A novel scenario after over thirty years from HIV discovery? Clinical experience and literature appraisal].

PubMed

Manfredi, Roberto; Cascavilla, Alessandra; Calza, Leonardo

2015-08-01

Both natural history and epidemiological trend of HIV infection have been deeply modified by the introduction of highly active antiretroviral therapy (HAART), around twenty years ago. However, despite a rapid drop of the incidence of the large majority of opportunistic infections, a slow, but continued increase of malignancies occurred, with particular evidence focused on cancers which are not strictly related to the definition of full blown AIDS (the so called non-AIDS-defining malignancies). The unique clinical occurrence of HIV infection complicated by even four non-AIDS-defining cancers prompted us to re-discuss the epidemiology and the possible pathogenesis, the clinical presentation, and the differential diagnosis of this pathologic presentation. On the ground of our experience in this field, and the available literature evidences, we discuss how this clinical occurrence is acting on HIV infection presentation during the HAART era of the third millennium. These changes need broad scale studies, and promise relevant consequences on etiopathogenetic, prevention, therapeutic, and management aspects of HIV disease in the next future.

Magnetic resonance imaging of hypertrophic olivary degeneration.

PubMed

Blanco Ulla, M; López Carballeira, A; Pumar Cebreiro, J M

2015-01-01

To review the pathophysiologic mechanisms involved in hypertrophic olivary degeneration, with attention to epidemiologic and clinical aspects and especially to imaging findings. We reviewed 5 patients diagnosed with hypertrophic olivary degeneration at our center from 2010 through 2013, analyzing relevant clinical, epidemiologic, and radiologic findings. In all cases, a hyperintensity was seen in the inferior olivary nuclei in FLAIR and T2-weighted sequences. No signal alterations were seen on T1-weighted sequences, and no enhancement was seen after intravenous injection of contrast material. In the cases studied by diffusion-weighted imaging, no significant alterations were seen in these sequences. Olivary hypertrophy was seen in all patients except in one, in whom presumably not enough time had elapsed for hypertrophy to occur. The alterations were bilateral in two of the five cases. Only one case exhibited the typical clinical manifestations. Given that patients may not present clinical manifestations that can be attributed to hypertrophic olivary degeneration, it is important to recognize the characteristic radiologic signs of this entity. Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

Maple syrup urine disease: mechanisms and management.

PubMed

Blackburn, Patrick R; Gass, Jennifer M; Vairo, Filippo Pinto E; Farnham, Kristen M; Atwal, Herjot K; Macklin, Sarah; Klee, Eric W; Atwal, Paldeep S

2017-01-01

Maple syrup urine disease (MSUD) is an inborn error of metabolism caused by defects in the branched-chain α-ketoacid dehydrogenase complex, which results in elevations of the branched-chain amino acids (BCAAs) in plasma, α-ketoacids in urine, and production of the pathognomonic disease marker, alloisoleucine. The disorder varies in severity and the clinical spectrum is quite broad with five recognized clinical variants that have no known association with genotype. The classic presentation occurs in the neonatal period with developmental delay, failure to thrive, feeding difficulties, and maple syrup odor in the cerumen and urine, and can lead to irreversible neurological complications, including stereotypical movements, metabolic decompensation, and death if left untreated. Treatment consists of dietary restriction of BCAAs and close metabolic monitoring. Clinical outcomes are generally good in patients where treatment is initiated early. Newborn screening for MSUD is now commonplace in the United States and is included on the Recommended Uniform Screening Panel (RUSP). We review this disorder including its presentation, screening and clinical diagnosis, treatment, and other relevant aspects pertaining to the care of patients.

Maple syrup urine disease: mechanisms and management

PubMed Central

Farnham, Kristen M; Atwal, Herjot K; Macklin, Sarah; Klee, Eric W; Atwal, Paldeep S

2017-01-01

Maple syrup urine disease (MSUD) is an inborn error of metabolism caused by defects in the branched-chain α-ketoacid dehydrogenase complex, which results in elevations of the branched-chain amino acids (BCAAs) in plasma, α-ketoacids in urine, and production of the pathognomonic disease marker, alloisoleucine. The disorder varies in severity and the clinical spectrum is quite broad with five recognized clinical variants that have no known association with genotype. The classic presentation occurs in the neonatal period with developmental delay, failure to thrive, feeding difficulties, and maple syrup odor in the cerumen and urine, and can lead to irreversible neurological complications, including stereotypical movements, metabolic decompensation, and death if left untreated. Treatment consists of dietary restriction of BCAAs and close metabolic monitoring. Clinical outcomes are generally good in patients where treatment is initiated early. Newborn screening for MSUD is now commonplace in the United States and is included on the Recommended Uniform Screening Panel (RUSP). We review this disorder including its presentation, screening and clinical diagnosis, treatment, and other relevant aspects pertaining to the care of patients. PMID:28919799

Neoclassical toroidal viscosity in perturbed equilibria with general tokamak geometry

NASA Astrophysics Data System (ADS)

Logan, Nikolas C.; Park, Jong-Kyu; Kim, Kimin; Wang, Zhirui; Berkery, John W.

2013-12-01

This paper presents a calculation of neoclassical toroidal viscous torque independent of large-aspect-ratio expansions across kinetic regimes. The Perturbed Equilibrium Nonambipolar Transport (PENT) code was developed for this purpose, and is compared to previous combined regime models as well as regime specific limits and a drift kinetic δf guiding center code. It is shown that retaining general expressions, without circular large-aspect-ratio or other orbit approximations, can be important at experimentally relevant aspect ratio and shaping. The superbanana plateau, a kinetic resonance effect recently recognized for its relevance to ITER, is recovered by the PENT calculations and shown to require highly accurate treatment of geometric effects.

Publications in anesthesia journals: quality and clinical relevance.

PubMed

Lauritsen, Jakob; Moller, Ann M

2004-11-01

Clinicians performing evidence-based anesthesia rely on anesthesia journals for clinically relevant information. The objective of this study was to analyze the proportion of clinically relevant articles in five high impact anesthesia journals. We evaluated all articles published in Anesthesiology, Anesthesia & Analgesia, British Journal of Anesthesia, Anesthesia, and Acta Anaesthesiologica Scandinavica from January to June, 2000. Articles were assessed and classified according to type, outcome, and design; 1379 articles consisting of 5468 pages were evaluated and categorized. The most common types of article were animal and laboratory research (31.2%) and randomized clinical trial (20.4%). A clinically relevant article was defined as an article that used a statistically valid method and had a clinically relevant end-point. Altogether 18.6% of the pages had as their subject matter clinically relevant trials. We compared the Journal Impact Factor (a measure of the number of citations per article in a journal) and the proportion of clinically relevant pages and found that they were inversely proportional to each other.

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership

PubMed Central

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Abstract Objective Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. Methods A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Results Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. Conclusion A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. PMID:29069424

The Clinical Neuroscience Course: Viewing Mental Health from Neurobiological Perspectives

PubMed Central

Lambert, Kelly G.

2005-01-01

Although the field of neuroscience is booming, a challenge for researchers in mental health disciplines is the integration of basic research findings into applied clinical approaches leading to effective therapies. Recently the National Institute of Mental Health called for translational research grants to encourage collaboration between neuroscientists and mental health professionals. In order for this “clinical neuroscience” to emerge and thrive, an important first step is the provision of appropriate course offerings so that future neuroscience researchers and mental health practitioners will have a common neurobiological base from which to make informed decisions about the most efficacious treatments for mental illnesses. Accordingly, an integrative course, Clinical Neuroscience, was developed to address these issues. After reviewing the historical origins of this emerging discipline, students are exposed to fundamental overviews of neuroanatomy, neurochemistry, and neural development before approaching the neurobiological components of several disorders (e.g., schizophrenia, depression, Tourette’s syndrome, drug abuse, obsessive compulsive disorder). Finally, the maintenance of mental health is emphasized as topics such as psychoneuroimmunology, coping with stress, and eating regulation are discussed. Important themes emphasized in this course include (1) the consideration of only empirically based evidence, (2) the view that mental illness represents a disruption of neurobiological homeostasis, (3) the acknowledgement that, because the brain is a plastic organ, the clinical relevance of environmental and behavioral influences is difficult to overestimate, and (4) the recognition of the value of ecologically relevant animal models in the investigation of various aspects of mental illness. Because of the importance of stress maintenance in mental health, exercises have been developed to increase students’ awareness of their own coping strategies. Finally, several books and movies are incorporated to provide additional points of view of the topics discussed in the course. PMID:23494100

Nutritional Management of Metabolic Endotoxemia: A Clinical Review.

PubMed

Brown, Benjamin I

2017-07-01

Context • Diet-induced, metabolic endotoxemia is emerging as an important contributory factor to the development of a wide range of chronic diseases, including cardiometabolic, autoimmune, psychiatric, and neurodegenerative illnesses. Emerging human clinical studies have demonstrated that diet and dietary components are potent modifiers of circulating endotoxins and can be used to reduce plasma levels significantly and improve metabolic health. Objective • The aim of the current study was to explore briefly the concept of metabolic endotoxemia and its relationship to disease development, to examine the influence of diet and dietary components on circulating endotoxins, and, finally, discuss the clinical relevance of nutritional interventions for management of metabolic endotoxemia. Design • The researcher performed a literature review of dietary and nutritional interactions with metabolic endotoxemia with a focus on studies relevant to clinical practice. Setting • The study took place at the UK College of Nutrition and Health (London, England). Results • Improving dietary quality, optimizing the intake of phytonutrient-rich foods, improving micronutrient status, consuming fermented foods, manipulating the gut microflora with prebiotics and probiotics, and using specific nutritional supplements, such as glutamine, lactoferrin, resveratrol, and berberine, have been shown to be effective in targeting metabolic endotoxemia. Conclusions • Diet, dietary components, and nutritional supplements, including prebiotics and probiotics, have demonstrated the ability to provide clinically important reductions in circulating endotoxins and improve related sequels, such as inflammation and other negative health markers. The development of personalized nutritional interventions for the management of metabolic endotoxemia is a promising area for future research due to the potential of such interventions to improve multiple aspects of human health and mitigate a wide range of chronic diseases.

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership.

PubMed

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Empty polyetheretherketone (PEEK) cages in anterior cervical diskectomy and fusion (ACDF) show slow radiographic fusion that reduces clinical improvement: results from the prospective multicenter "PIERCE-PEEK" study.

PubMed

Suess, Olaf; Schomaker, Martin; Cabraja, Mario; Danne, Marco; Kombos, Theodoros; Hanna, Michael

2017-01-01

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment for radiculopathy and myelopathy. Previous studies showed that empty PEEK cages have lower radiographic fusion rates, but the clinical relevance remains unclear. This paper's aim is to provide high-quality evidence on the outcomes of ACDF with empty PEEK cages and on the relevance of radiographic fusion for clinical outcomes. This large prospective multicenter clinical trial performed single-level ACDF with empty PEEK cages on patients with cervical radiculopathy or myelopathy. The main clinical outcomes were VAS (0-10) for pain and NDI (0-100) for functioning. Radiographic fusion was evaluated by two investigators for three different aspects. The median (range) improvement of the VAS pain score was: 3 (1-6) at 6 months, 3 (2-8) at 12 months, and 4 (2-8) at 18 months. The median (range) improvement of the NDI score was: 12 (2-34) at 6 months, 18 (4-46) at 12 months, and 22 (2-44) at 18 months. Complete radiographic fusion was reached by 126 patients (43%) at 6 months, 214 patients (73%) at 12 months, and 241 patients (83%) at 18 months. Radiographic fusion was a highly significant ( p  < 0.001) predictor of the improvement of VAS and NDI scores. This study provides strong evidence that ACDF is effective treatment, but the overall rate of radiographic fusion with empty PEEK cages is slow and insufficient. Lack of complete radiographic fusion leads to less improvement of pain and disability. We recommend against using empty uncoated pure PEEK cages in ACDF. ISRCTN42774128. Retrospectively registered 14 April 2009.

Understanding fertilization through intracytoplasmic sperm injection (ICSI).

PubMed

Neri, Queenie V; Lee, Bora; Rosenwaks, Zev; Machaca, Khaled; Palermo, Gianpiero D

2014-01-01

Since the establishment of in vitro fertilization, it became evident that almost half of the couples failed to achieve fertilization and this phenomenon was attributed to a male gamete dysfunction. The adoption of assisted fertilization techniques particularly ICSI has been able to alleviate male factor infertility by granting the consistent ability of a viable spermatozoon to activate an oocyte. Single sperm injection, by pinpointing the beginning of fertilization, has been an invaluable tool in clarifying the different aspects of early fertilization and syngamy. However, even with ICSI some couples fail to fertilize due to ooplasmic dysmaturity in relation to the achieved nuclear maturation marked by the extrusion of the first polar body. More uncommon are cases where the spermatozoa partially or completely lack the specific oocyte activating factor. In this work, we review the most relevant aspects of fertilization and its failure through assisted reproductive technologies. Attempts at diagnosing and treating clinical fertilization failure are described. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Classification in childhood disability: focusing on function in the 21st century.

PubMed

Rosenbaum, Peter; Eliasson, Ann-Christin; Hidecker, Mary Jo Cooley; Palisano, Robert J

2014-08-01

Classification systems in health care are usually based on current understanding of the condition. They are often derived empirically and adopted applying sound principles of measurement science to assess whether they are reliable (consistent) and valid (true) for the purposes to which they are applied. In the past 15 years, the authors have developed and validated classification systems for specific aspects of everyday function in people with cerebral palsy--gross motor function, manual abilities, and communicative function. This article describes the approaches used to conceptualize each aspect of function, develop the tools, and assess their reliability and validity. We report on the utility of each system with respect to clinical applicability, use of these tools for research, and the uptake and impact that they have had around the world. We hope that readers will find these accounts interesting, relevant, and applicable to their daily work with children and youth with disabilities. © The Author(s) 2014.

Medical Information & Technology: Rapidly Expanding Vast Horizons

NASA Astrophysics Data System (ADS)

Sahni, Anil K.

2012-12-01

During ÑMedical Council Of India?, Platinum Jubilee Year (1933-2008) Celebrations, In Year 2008, Several Scientific Meeting/Seminar/Symposium, On Various Topics Of Contemporary Importance And Relevance In The Field Of ÑMedical Education And Ethics?, Were Organized, By Different Medical Colleges At Various Local, State, National Levels. The Present Discussion, Is An Comprehensive Summary Of Various Different Aspects of ìMedical Information Communication Technologyî, Especially UseFul For The Audience Stratum Group Of Those Amateur Medical & Paramedical Staff, With No Previous Work Experience Knowledge Of Computronics Applications. Outlining The, i.Administration Applications: Medical Records Etc, ii. Clinical Applications: Pros pective Scope Of TeleMedicine Applicabilities Etc iii. Other Applications: Efforts To Augment Improvement Of Medical Education, Medical Presentations, Medical Education And Research Etc. ÑMedical Trancription? & Related Recent Study Fields e.g ÑModern Pharmaceuticals?,ÑBio-Engineering?, ÑBio-Mechanics?, ÑBio-Technology? Etc., Along With Important Aspects Of Computers-General Considerations, Computer Ergonomics Assembled To Summarize, The AwareNess Regarding Basic Fundamentals Of Medical Computronics & Its Practically SuccessFul Utilities.

Alterations in Hair Follicle Dynamics in Women

PubMed Central

Piérard-Franchimont, Claudine; Piérard, Gérald E.

2013-01-01

Endocrine changes supervening after parturition and menopause participate in the control of sebum production and hair growth modulation. The ensuing conditions include some peculiar aspects of hair loss (effluvium), alopecia, and facial hirsutism. The hair cycling is of major clinical relevance because most hair growth disorders result from disturbances in this chronobiological feature. Of note, any correlation between a biologic abnormality and hair cycling disturbance does not prove a relationship of causality. The proportion of postmenopausal women is rising in the overall population. Therefore, the prevalence of these hair follicle disturbances is globally on the rise. Current therapies aim at correcting the underlying hormonal imbalances, and at improving the overall cosmetic appearance. However, in absence of pathogenic diagnosis and causality criteria, chances are low that a treatment given by the whims of fate will adequately control hair effluvium. The risk and frequency of therapeutic inertia are further increased. When the hair loss is not controlled and/or compensated by growth of new hairs, several clinical aspects of alopecia inexorably develop. Currently, there is little evidence supporting any specific treatment for these endocrine hair disorders in post-partum and postmenopausal women. Current hair treatment strategies are symptomatic and nonspecific so current researchers aim at developing new, targeted methods. PMID:24455742

Status of ionization chambers calibration for radiation therapy in Brazil

NASA Astrophysics Data System (ADS)

Gonçalves, M.; Joana, G.; Leal, P.; Vasconcelos, R.; do Couto, N.; Teixeira, F. C.; Soares, A. D.; Santini, E. S.; Salata, C.

2018-03-01

CNEN makes a constant effort to keep updated with international standards and national needs to strengthen the radiological protection status of the country. The guidelines related to radiation treatment facilities have been revised in the last five years in order to take in consideration the most relevant aspects of the growing technology as well as to mitigate the accidents or incidents observed in practice. Hence, clinical dosimeters have gained special importance as significant items in Brazilian regulation. In the present work we discuss the importance of inspections from the point of view of equipment dosimetry and instruments quality control. The dosimeter sets based on thimble and well ionization chambers need periodic calibration, and this calibration becomes a fundamental task in order to guarantee the dose prescribed-delivered to patients. Thus Brazilian guidelines enforce the need of at least two sets of clinical dosimeters with thimble chambers calibrated and one set of electrometer with well ionization chamber for hdr equipment. We call attention to the fact that inspections are a very valuable tool in order to enforce the application of guidelines around the country both by enlightening the weaker aspects of facilities concerning radiological protection and by stating in loco that reasons which lead the regulatory body to enforce such guidelines items.

Mechanisms of fibrin polymerization and clinical implications

PubMed Central

Litvinov, Rustem I.

2013-01-01

Research on all stages of fibrin polymerization, using a variety of approaches including naturally occurring and recombinant variants of fibrinogen, x-ray crystallography, electron and light microscopy, and other biophysical approaches, has revealed aspects of the molecular mechanisms involved. The ordered sequence of fibrinopeptide release is essential for the knob-hole interactions that initiate oligomer formation and the subsequent formation of 2-stranded protofibrils. Calcium ions bound both strongly and weakly to fibrin(ogen) have been localized, and some aspects of their roles are beginning to be discovered. Much less is known about the mechanisms of the lateral aggregation of protofibrils and the subsequent branching to yield a 3-dimensional network, although the αC region and B:b knob-hole binding seem to enhance lateral aggregation. Much information now exists about variations in clot structure and properties because of genetic and acquired molecular variants, environmental factors, effects of various intravascular and extravascular cells, hydrodynamic flow, and some functional consequences. The mechanical and chemical stability of clots and thrombi are affected by both the structure of the fibrin network and cross-linking by plasma transglutaminase. There are important clinical consequences to all of these new findings that are relevant for the pathogenesis of diseases, prophylaxis, diagnosis, and treatment. PMID:23305734

[Acne vulgaris: morphologic, endocrinologic and psychosomatic aspects].

PubMed

Welp, K; Gieler, U

1990-12-01

25 male patients suffering from acne vulgaris were examined by means of endocrinological, morphological, and 5 psychometric procedures in order to check the correlations and interactions between the psychological and dermatological aspects of the disease. In comparison with a control group, the acne patients did not show any striking endocrinological abnormalities; we found no correlation between the extensiveness of the lesions and the level of DHEA sulphate. All the psychological tests yielded results deviating from those achieved by the representative controls, but they were comparable with those of other patients suffering from psychosomatic diseases. The individual feeling of being "disfigured" found its expression in self-consciousness, lack of trust in his/her own body, as well as the clinically relevant difference between his/her conception of self and the ideal of self. During times of enhanced psychosocial strains subjectively assumed by the patients, the lesions increased and the patients were disturbed in social interaction and communication. Surprisingly, we did not find any correlation between the clinical status and significant psychometric findings. Our results show that in acne vulgaris, the individual experience of wanting physical attractiveness, associated with a predominantly neurotic depressive personal structure, may play a central part in a disturbed process of interaction with the environment and suggest the influence of psychic factors in the pathogenesis of acne vulgaris.

[From querulous neurosis to querulous delusion: the psychopathological aspects of persistent dysfunctional complaining].

PubMed

Tewarie, P R M; van der Zwaard, R

2016-01-01

The clinical concept of querulous behaviour is used only sporadically in modern psychiatry, although the concept seems to be just as clinical relevant as it was many years ago. The extension of the right to complain has played a role in the acceptance of querulous behaviour. Judicial bodies and other government organisations are being kept busier than ever because people who feel they have been denied justice became entangled in interminable litigation. Gradually, querulous behaviour causes the initial sense of injustice to disappear and querulous patients are damaged economically, socially and personally and experience suffering and function less efficiently. To describe the history, clinical features, differential diagnosis, possible psychodynamic hypotheses and possible ways of treating querulous behaviour.
We studied the literature using PubMed, PsychInfo, Google and Google Scholar. There seems to be a spectrum with fluent transitions from normal complaining behaviour, querulous behaviour which is based on a paranoid, narcissistic or obsessive-compulsive personality structure, to severe pathologies like a delusional disorder. There is little evidence that pharmacotherapy or psychotherapy is effective. Nevertheless, there are opportunities for administering psychiatric treatment in order to alleviate the loss and suffering for the patients and their next-of-kin. Querulous behaviour is an old clinical concept that still has relevance today for the individual patient, complaints officers and society in general. Our current diagnostic systems provide sufficient opportunities for diagnosing patients correctly. Patients may be best served by judicial mediation at an early stage, combined with psychiatric treatment aimed at controlling emotions and restricting harmful behaviour.

FOTROCAN Delphi consensus statement regarding the prevention and treatment of cancer-associated thrombosis in areas of uncertainty and low quality of evidence.

PubMed

Jimenez-Fonseca, P; Carmona-Bayonas, A; Calderon, C; Fontcuberta Boj, J; Font, C; Lecumberri, R; Monreal, M; Muñoz Martín, A J; Otero, R; Rubio, A; Ruiz-Artacho, P; Suarez Fernández, C; Colome, E; Pérez Segura, P

2017-08-01

Decision-making in cancer-related venous thromboembolism (VTE) is often founded on scant lines of evidence and weak recommendations. The aim of this work is to evaluate the percentage of agreement surrounding a series of statements about complex, clinically relevant, and highly uncertain aspects to formulate explicit action guidelines. Opinions were based on a structured questionnaire with appropriate scores and were agreed upon using a Delphi method. Questions were selected based on a list of recommendations with low evidence from the Spanish Society of Oncology Clinical Guideline for Thrombosis. The questionnaire was completed in two iterations by a multidisciplinary panel of experts in thrombosis. Of the 123 statements analyzed, the panel concurred on 22 (17%) and another 81 (65%) were agreed on by qualified majority, including important aspects of long-term and prolonged anticoagulation, major bleeding and rethrombosis management, treatment in special situations, catheter-related thrombosis and thromboprophylaxis. Among them, the panelists agreed the incidental events should be equated to symptomatic ones, long-term and extended use of full-dose low-molecular weight heparin, and concluded that the Khorana score is not sensitive enough to uphold an effective thromboprophylaxis strategy. Though the level of consensus varied depending on the scenario presented, overall, the iterative process achieved broad agreement as to the general treatment principles of cancer-associated VTE. Clinical validation of these statements in genuine practice conditions would be useful.

Computed tomographic findings in dogs and cats with temporomandibular joint disorders: 58 cases (2006–2011)

PubMed Central

Arzi, Boaz; Cissell, Derek D.; Verstraete, Frank J. M.; Kass, Philip H.; DuRaine, Grayson D.; Athanasiou, Kyriacos A.

2013-01-01

Objective To describe CT findings in dogs and cats with temporomandibular joint (TMJ) disorders. Design Retrospective case-series. Animals 41 dogs and 17 cats. Procedures Medical records and CT images of the skull were reviewed for dogs and cats that were examined at a dentistry and oral surgery specialty practice between 2006 and 2011. Results Of 142 dogs and 42 cats evaluated, 41 dogs and 17 cats had CT findings consistent with a TMJ disorder. In dogs, the most common TMJ disorder was osteoarthritis; however, in most cases, there were other TMJ disorders present in addition to osteoarthritis. Osteoarthritis was more frequently identified at the medial aspect rather than the lateral aspect of the TMJ, whereas the frequency of osteoarthritic involvement of the dorsal and ventral compartments did not differ significantly. In cats, fractures were the most common TMJ disorder, followed by osteoarthritis. Clinical signs were observed in all dogs and cats with TMJ fractures, dysplasia, ankylosis, luxation, and tumors; however, only 4 of 15 dogs and 2 of 4 cats with osteoarthritis alone had clinical signs. Conclusions and Clinical Relevance Results indicated that TMJ disorders are frequently present in combination. Osteoarthritis was the most common TMJ disorder in dogs and the second most common TMJ disorder in cats. Computed tomography should be considered as a tool for the diagnosis of TMJ disorders in dogs and cats with suspected orofacial disorders and pain. PMID:23234284

Eosinophilic oesophagitis: Current evidence-based diagnosis and treatment.

PubMed

Lucendo, Alfredo J; Molina-Infante, Javier

2018-04-01

Eosinophilic oesophagitis (EoE) is a disease caused by an immune response to food antigens in contact with the oesophageal mucosa. Its diagnosis is defined by the combination of oesophageal dysfunction symptoms and inflammation of the oesophageal mucosa predominantly by eosinophils. Its chronic course and frequent progression to subepithelial fibrosis and oesophageal strictures indicate the need for treatment. The information provided by recent clinical trials and systematic reviews has led to the development of new clinical guidelines, endorsed by several European scientific societies. This review includes the most relevant aspects of the new guidelines, updates the EoE concept and reports its epidemiology and risk factors, associated conditions and its natural history in children and adults. Diagnostic criteria are provided, and tests for EoE diagnosis and monitoring and therapeutic options are analysed based on the best scientific evidence and consensus opinion of experts. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Ultrasound guidance in regional anesthesia: state of the art review through challenging clinical scenarios

PubMed Central

Sites, Brian D; Antonakakis, John G

2009-01-01

Ultrasound guided regional anesthesia (UGRA) for peripheral nerve blockade is becoming increasingly popular. The advantage of ultrasound technology is that it affords the anesthesiologist the real time ability to visualize neural structures, needle advancement, and local anesthetic spread. Recent data suggest that UGRA generates improved success rates and reductions in performance times in comparison to traditional approaches. Further, the use of ultrasound technology in peripheral nerve blocks has provided insight into needle–nerve interactions, revealing distinct limitations of nerve stimulator techniques. Given that UGRA requires a unique set of skills, formal standards and guidelines are currently being developed by leadership societies in order to foster education and training. This review article, in a case vignette format, highlights important techniques, concepts, and limitations regarding the use of ultrasound to facilitate regional anesthesia. Clinically relevant aspects of ultrasound physics are also discussed. PMID:22915860

EAACI Food Allergy and Anaphylaxis Guidelines. Food allergy health-related quality of life measures.

PubMed

Muraro, A; Dubois, A E J; DunnGalvin, A; Hourihane, J O'B; de Jong, N W; Meyer, R; Panesar, S S; Roberts, G; Salvilla, S; Sheikh, A; Worth, A; Flokstra-de Blok, B M J

2014-07-01

Instruments have been developed and validated for the measurement of health-related quality of life in patients with food allergy. This guideline has been prepared by the European Academy of Allergy and Clinical Immunology's (EAACI) Guidelines for Food Allergy and Anaphylaxis Group. It draws on a systematic review of the literature on quality of life instruments for food allergy and the Appraisal of Guidelines for Research & Evaluation (AGREE II) guideline development process. Guidance is provided on the use of such instruments in research, and the current limitations of their use in clinical practice are described. Gaps in current knowledge as well as areas of future interest are also discussed. This document is relevant to healthcare workers dealing with food-allergic patients, scientists engaging in food allergy research and policy makers involved in regulatory aspects concerning food allergy and safety. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A study of an ethics education topic for undergraduate nursing students.

PubMed

Kalaitzidis, Evdokia; Schmitz, Karl

2012-01-01

The study aims to explore nursing students' perceptions of the relative value of various aspects of the ethical component of the undergraduate topic, 'Ethics and Law applied to Nursing' (topic NURS2104). To enable time for reflection on ethics in nursing, sampling occurred 1 year after successful completion of the above-mentioned topic and after successful completion of all but the final clinical experience components of the Bachelor of Nursing (BN) degree. A significant proportion of respondents perceived ethics education as relevant to professional practices. It is also noteworthy that the ethical decision-making strategies that had been incorporated into the topic (NURS2104) became transformed by the clinical experience of each particular student. While results of this study are not conclusive, they nevertheless provide important information for future nursing students on the evolutionary development of ethics education. Copyright © 2011 Elsevier Ltd. All rights reserved.

Health Disparities in Women

PubMed Central

Hornbuckle, Lyndsey M; Amutah-Onukagha, Ndidiamaka; Bryan, Alicia; Skidmore Edwards, Elizabeth; Madzima, Takudzwa; Massey, Kelly; May, Linda; Robinson, Leah E

2017-01-01

AIMS AND SCOPE Clinical Medicine Insights: Women’s Health is an international, open-access, peer-reviewed journal which considers manuscripts on all aspects of the diagnosis, management, and prevention of disorders specific to women, in addition to related genetic, pathophysiological, and epidemiological topics. Clinical Medicine Insights: Women’s Health aims to provide researchers working in this complex, quickly developing field with online, open access to highly relevant scholarly articles by leading international researchers. In a field where the literature is ever-expanding, researchers increasingly need access to up-to-date, high-quality scholarly articles on areas of specific contemporary interest. This supplement is on Health Disparities in Women. This supplement aims to address this by presenting high-quality articles that allow readers to distinguish the signal from the noise. The editor in chief hopes that through this effort, practitioners and researchers will be aided in finding answers to some of the most complex and pressing issues of our time. PMID:28579867

Multitasking Abilities in Adolescents With 22q11.2 Deletion Syndrome: Results From an Experimental Ecological Paradigm.

PubMed

Schneider, Maude; Eliez, Stephan; Birr, Julie; Menghetti, Sarah; Debbané, Martin; Van der Linden, Martial

2016-03-01

The 22q11.2 deletion syndrome (22q11.2DS) is associated with cognitive and functional impairments and increased risk for schizophrenia. We characterized multitasking abilities of adolescents with 22q11.2DS using an experimental naturalistic setting and examined whether multitasking impairments were associated with real-world functioning and negative symptoms. Thirty-nine adolescents (19 with 22q11.2DS and 20 controls) underwent the Multitasking Evaluation for Adolescents. Real-world functioning and clinical symptoms were assessed in participants with 22q11.2DS. Adolescents with 22q11.2DS performed poorly in the multitasking evaluation. Our data also suggest that multitasking abilities are related to adaptive functioning in the practical domain and negative symptoms. This study shows that adolescents with 22q11.2DS are characterized by multitasking impairments, which may be relevant for several aspects of the clinical phenotype.

Status epilepticus in the elderly: epidemiology, clinical aspects and treatment

PubMed Central

de Assis, Telma M.R.; Costa, Gersonita; Bacellar, Aroldo; Orsini, Marco; Nascimento, Osvaldo J.M.

2012-01-01

The aim of the study was to review the epidemiology, clinical profile and discuss the etiology, prognosis and treatment options in patients aged 60 years or older presenting with status epilepticus. We performed a systematic review involving studies published from 1996 to 2010, in Medline/PubMed, Scientific Electronic Library on line (Scielo), Latin-American and Caribbean Center of Health Sciences Information (Lilacs) databases and textbooks. Related articles published before 1996, when relevant for discussing epilepsy in older people, were also included. Several population studies had shown an increased incidence of status epilepticus after the age of 60 years. Status epilepticus is a medical and neurological emergency that is associated with high morbidity and mortality, and is a major concern in the elderly compared to the general population. Prompt diagnosis and effective treatment of convulsive status epilepticus are crucial to avoid brain injury and reduce the fatality rate in this age group. PMID:23355930

Brain Dynamics: Methodological Issues and Applications in Psychiatric and Neurologic Diseases

NASA Astrophysics Data System (ADS)

Pezard, Laurent

The human brain is a complex dynamical system generating the EEG signal. Numerical methods developed to study complex physical dynamics have been used to characterize EEG since the mid-eighties. This endeavor raised several issues related to the specificity of EEG. Firstly, theoretical and methodological studies should address the major differences between the dynamics of the human brain and physical systems. Secondly, this approach of EEG signal should prove to be relevant for dealing with physiological or clinical problems. A set of studies performed in our group is presented here within the context of these two problematic aspects. After the discussion of methodological drawbacks, we review numerical simulations related to the high dimension and spatial extension of brain dynamics. Experimental studies in neurologic and psychiatric disease are then presented. We conclude that if it is now clear that brain dynamics changes in relation with clinical situations, methodological problems remain largely unsolved.

TU-E-BRB-03: Overview of Proposed TG-132 Recommendations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brock, K.

2015-06-15

Deformable image registration (DIR) is developing rapidly and is poised to substantially improve dose fusion accuracy for adaptive and retreatment planning and motion management and PET fusion to enhance contour delineation for treatment planning. However, DIR dose warping accuracy is difficult to quantify, in general, and particularly difficult to do so on a patient-specific basis. As clinical DIR options become more widely available, there is an increased need to understand the implications of incorporating DIR into clinical workflow. Several groups have assessed DIR accuracy in clinically relevant scenarios, but no comprehensive review material is yet available. This session will alsomore » discuss aspects of the AAPM Task Group 132 on the Use of Image Registration and Data Fusion Algorithms and Techniques in Radiotherapy Treatment Planning official report, which provides recommendations for DIR clinical use. We will summarize and compare various commercial DIR software options, outline successful clinical techniques, show specific examples with discussion of appropriate and inappropriate applications of DIR, discuss the clinical implications of DIR, provide an overview of current DIR error analysis research, review QA options and research phantom development and present TG-132 recommendations. Learning Objectives: Compare/contrast commercial DIR software and QA options Overview clinical DIR workflow for retreatment To understand uncertainties introduced by DIR Review TG-132 proposed recommendations.« less

Evaluation of a Partial Genome Screening of Two Asthma Susceptibility Regions Using Bayesian Network Based Bayesian Multilevel Analysis of Relevance

PubMed Central

Antal, Péter; Kiszel, Petra Sz.; Gézsi, András; Hadadi, Éva; Virág, Viktor; Hajós, Gergely; Millinghoffer, András; Nagy, Adrienne; Kiss, András; Semsei, Ágnes F.; Temesi, Gergely; Melegh, Béla; Kisfali, Péter; Széll, Márta; Bikov, András; Gálffy, Gabriella; Tamási, Lilla; Falus, András; Szalai, Csaba

2012-01-01

Genetic studies indicate high number of potential factors related to asthma. Based on earlier linkage analyses we selected the 11q13 and 14q22 asthma susceptibility regions, for which we designed a partial genome screening study using 145 SNPs in 1201 individuals (436 asthmatic children and 765 controls). The results were evaluated with traditional frequentist methods and we applied a new statistical method, called Bayesian network based Bayesian multilevel analysis of relevance (BN-BMLA). This method uses Bayesian network representation to provide detailed characterization of the relevance of factors, such as joint significance, the type of dependency, and multi-target aspects. We estimated posteriors for these relations within the Bayesian statistical framework, in order to estimate the posteriors whether a variable is directly relevant or its association is only mediated. With frequentist methods one SNP (rs3751464 in the FRMD6 gene) provided evidence for an association with asthma (OR = 1.43(1.2–1.8); p = 3×10−4). The possible role of the FRMD6 gene in asthma was also confirmed in an animal model and human asthmatics. In the BN-BMLA analysis altogether 5 SNPs in 4 genes were found relevant in connection with asthma phenotype: PRPF19 on chromosome 11, and FRMD6, PTGER2 and PTGDR on chromosome 14. In a subsequent step a partial dataset containing rhinitis and further clinical parameters was used, which allowed the analysis of relevance of SNPs for asthma and multiple targets. These analyses suggested that SNPs in the AHNAK and MS4A2 genes were indirectly associated with asthma. This paper indicates that BN-BMLA explores the relevant factors more comprehensively than traditional statistical methods and extends the scope of strong relevance based methods to include partial relevance, global characterization of relevance and multi-target relevance. PMID:22432035

Subchondral drilling for articular cartilage repair: a systematic review of translational research.

PubMed

Gao, Liang; Goebel, Lars K H; Orth, Patrick; Cucchiarini, Magali; Madry, Henning

2018-05-03

Articular cartilage defects may initiate osteoarthritis. Subchondral drilling, a widely applied clinical technique to treat small cartilage defects, does not yield cartilage regeneration. Various translational studies aiming to improve the outcome of drilling have been performed, however, a robust systematic analysis of its translational evidence has been still lacking. Here, we performed a systematic review of the outcome of subchondral drilling for knee cartilage repair in translational animal models. A total of 12 relevant publications studying 198 animals were identified, detailed study characteristics were extracted, and methodological quality and risk of bias were analyzed. Subchondral drilling was superior to defects untreated or treated with abrasion arthroplasty for cartilage repair in multiple translational models. Considerable subchondral bone changes were observed, including subchondral bone cysts and intralesional osteophytes. Furthermore, extensive alterations of the subchondral bone microarchitecture appeared in a temporal pattern in small and large animal models, together with specific topographic aspects of repair. Moreover, variable technical aspects directly affected the outcomes of osteochondral repair. The data from this systematic review indicate that subchondral drilling yields improved short-term structural articular cartilage repair compared with spontaneous repair in multiple small and large animal models. These results have important implications for future investigations aimed at an enhanced translation into clinical settings for the treatment of cartilage defects, highlighting the importance of considering specific aspects of modifiable variables such as improvements in the design and reporting of preclinical studies, together with the need to better understand the underlying mechanisms of cartilage repair following subchondral drilling. © 2018. Published by The Company of Biologists Ltd.

Detection of an epidermoid cyst in the foot of a horse by use of magnetic resonance imaging.

PubMed

Sanz, Macarena G; Sampson, Sarah N; Schneider, Robert K; Gavin, Patrick R; Baszler, Timothy V

2006-06-15

CASE DESCRIPTION-A 4-year-old Quarter Horse stallion was evaluated because of a 10-month history of moderate (grade 3/5) left forelimb lameness (detectable during trotting over a smooth, hard surface). CLINICAL FINDINGS-No abnormalities were detected in either forelimb via palpation or application of hoof testers; however, lameness was eliminated after administration of a palmar digital nerve block in the left forelimb. Whereas radiography and ultrasonography did not identify any left forelimb foot abnormalities, magnetic resonance (MR) imaging revealed a circumscribed soft tissue mass in the distal aspect of the digital flexor tendon sheath (DFTS) dorsal to the lateral aspect of the deep digital flexor tendon. Subsequently, the left forelimb DFTS was injected with local anesthetic, which resulted in 90% improvement of the horse's lameness. TREATMENT AND OUTCOME-The distal aspect of the left forelimb DFTS was evaluated tenoscopically. The mass was removed under tenoscopic guidance, after which the distal digital annular ligament was transected. The horse received phenylbutazone orally for 10 days, and the left forelimb DFTS was injected with hyaluronic acid and methylprednisolone acetate 7 days after the surgery. Following a rehabilitation program, the horse was returned to full training at 6 months after surgery and competed successfully during a 2-year follow-up period. CLINICAL RELEVANCE-Use of MR imaging should be considered in all lame horses for which a definitive diagnosis cannot be made via radiography, ultrasonography, or other imaging techniques, especially when the lameness has been localized to a specific anatomic region by use of diagnostic anesthesia.

Meth Mouth—A Growing Epidemic in Dentistry?

PubMed Central

Pabst, Andreas; Castillo-Duque, Juan Carlos; Mayer, Axel; Klinghuber, Marcus; Werkmeister, Richard

2017-01-01

In the past two decades, the synthetic style and fashion drug “crystal meth” (“crystal”, “meth”), chemically representing the crystalline form of the methamphetamine hydrochloride, has become more and more popular in the United States, in Eastern Europe, and just recently in Central and Western Europe. “Meth” is cheap, easy to synthesize and to market, and has an extremely high potential for abuse and dependence. As a strong sympathomimetic, “meth” has the potency to switch off hunger, fatigue and, pain while simultaneously increasing physical and mental performance. The most relevant side effects are heart and circulatory complaints, severe psychotic attacks, personality changes, and progressive neurodegeneration. Another effect is “meth mouth”, defined as serious tooth and oral health damage after long-standing “meth” abuse; this condition may become increasingly relevant in dentistry and oral- and maxillofacial surgery. There might be an association between general methamphetamine abuse and the development of osteonecrosis, similar to the medication-related osteonecrosis of the jaws (MRONJ). Several case reports concerning “meth” patients after tooth extractions or oral surgery have presented clinical pictures similar to MRONJ. This overview summarizes the most relevant aspect concerning “crystal meth” abuse and “meth mouth”. PMID:29563435

[Relevance of five core aspects of the pre-anesthesia visit: results of a patient survey].

PubMed

Aust, H; Eberhart, L H J; Kalmus, G; Zoremba, M; Rüsch, D

2011-05-01

Due to a variety of reasons (e.g. increase in outpatient surgery and legal restrictions related to working hours) it has become increasingly more difficult to have the pre-anesthesia visit and the anesthesia carried out by the same anesthetist. In the light of these organizational changes as well as increasing economical pressure it has become common practice to implement pre-anesthesia assessment clinics. It is unclear, however, if these changes in anesthetic patient care respect patient needs. By means of a survey using the willingness to pay method, the relative significance of five quality aspects (location of pre-anesthesia visit, waiting time, patient-physician relationship, use of multimedia and ambience) were studied. Participation during a 12-month study period was on a voluntary basis. Of the 1,058 questionnaires, 1,014 were eligible for analysis. A pre-anesthesia visit performed by the anesthetist who would deliver anesthesia was the most important aspect for almost two thirds (624 out of 1,014) of the patients with on average more than one third of the money available spent on this item. Waiting time was the second most important factor with about one third of the patients rating this item as the most relevant factor and on average approximately one quarter of the total money available spent on it. Location of the pre-anesthesia visit, use of multimedia and ambience were considered least important. The order of these preferences was regardless of age and gender of subjects. However, there was a trend to age and gender-specific differences concerning the amount of money spent on these five items. For instance, with increasing age, patient-physician relationship and location of the pre-anesthesia visit become more important. These results suggest that the integration of a pre-anesthesia assessment clinic in anesthetic patient care is not favorable from the patients' point of view because getting to know the anesthetist who will deliver anesthesia is of paramount importance to most patients. In cases where a pre-anesthetic assessment clinic is indispensable, other measures to build up confidence compensating for the lack of personal patient-physician relationship should be developed. In this respect, the promotion of a corporate identity of the whole anesthesia department may be beneficial. Furthermore, keeping the waiting time as short as possible should be a high priority as this item was rated the second most important factor.

The Role of Twelve-Step-Related Spirituality in Addiction Recovery.

PubMed

Dermatis, Helen; Galanter, Marc

2016-04-01

This paper reviews empirical studies conducted on the role of spirituality and religiosity (S/R) characteristics in 12-step recovery among program members followed up after substance abuse treatment and those assessed independent of formal treatment. Aspects of spiritual functioning that change in relation to program participation and those S/R characteristics that were found to mediate the association between program involvement and drinking-related outcomes are discussed. In addition, a review is provided of 12-step program studies investigating S/R-related predictors of clinical outcomes relevant to risk of relapse among members in long-term recovery. To further examine the role of S/R characteristics in recovery, a study was conducted on long-term AA members to assess the relationship of S/R characteristics and AA program involvement to craving for alcohol and emotional distress after controlling for relevant demographic variables. Feeling God's presence daily, believing in a higher power as a universal spirit, and serving as an AA sponsor were all predictive of positive outcomes.

Alleged biological father incest: a forensic approach.

PubMed

Gomes, Vânia; Jardim, Patrícia; Taveira, Francisco; Dinis-Oliveira, Ricardo J; Magalhães, Teresa

2014-01-01

Paternal incest is one of the most serious forms of intrafamilial sexual abuse with clinical, social, and legal relevance. A retrospective study was performed, based on forensic reports and judicial decisions of alleged cases of biological paternal incest of victims under 18 years old (n = 215) from 2003 to 2008. Results highlight that in a relevant number of cases: victims were female; the abuse begun at an early age with reiteration; the alleged perpetrator presented a history of sexual crimes against children; sexual practices were physically poorly intrusive, which associated with a forensic medical evaluation performed more than 72 h after the abuse, explain partially the absence of physical injuries or other evidence-these last aspects are different from extrafamilial cases. In conclusion, observations about paternal incest are likely to exacerbate the psychosocial consequences of the abuse and may explain the difficulty and delay in detect and disclose these cases. Few cases were legally prosecuted and convicted. © 2013 American Academy of Forensic Sciences.

Attachment and Chronic Pain in Children and Adolescents

PubMed Central

Donnelly, Theresa J.; Jaaniste, Tiina

2016-01-01

Although attachment theory is not new, its theoretical implications for the pediatric chronic pain context have not been thoroughly considered, and the empirical implications and potential clinical applications are worth exploring. The attachment framework broadly focuses on interactions between a child’s developing self-regulatory systems and their caregiver’s responses. These interactions are believed to create a template for how individuals will relate to others in the future, and may help account for normative and pathological patterns of emotions and behavior throughout life. This review outlines relevant aspects of the attachment framework to the pediatric chronic pain context. The theoretical and empirical literature is reviewed regarding the potential role of attachment-based constructs such as vulnerability and maintaining factors of pediatric chronic pain. The nature and targets of attachment-based pediatric interventions are considered, with particular focus on relevance for the pediatric chronic pain context. The potential role of attachment style in the transition from acute to chronic pain is considered, with further research directions outlined. PMID:27792141

State of the art on nailfold capillaroscopy in dermatomyositis and polymyositis.

PubMed

Bertolazzi, Chiara; Cutolo, Maurizio; Smith, Vanessa; Gutierrez, Marwin

2017-12-01

To provide an overview of the main nailfold capillaroscopy (NFC) changes described in dermatomyositis (DM) and polymyositis (PM) and to discuss the current evidence supporting its clinical relevance and applications in daily practice. All relevant literature in the field of NFC and DM and PM published in the last 30 years has been systematically reviewed. A systematic research was performed in the electronic databases PubMed and EMBASE. A total of 540 publications were identified according to the proposed filters and 27 were included for the review. The articles have been critically analyzed with a focus on technical aspects, examined anatomical areas, main pathological capillaroscopy findings ,and the relationship between NFC alterations and critical parameters of DM and PM. The overview confirms that NFC is a safe and noninvasive tool able to help the clinician in the diagnosis of DM and PM and to better characterize the phase of disease activity of these patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Treatment resistance and psychodynamic psychiatry: concepts psychiatry needs from psychoanalysis.

PubMed

Plakun, Eric

2012-06-01

Over the last 30 years psychiatry and psychoanalysis have moved in substantially divergent directions. Psychiatry has become rich in methodology but conceptually limited, with a drift toward biological reductionism. Psychoanalysis has remained relatively limited in methodology, but conceptually rich. The rich methodology of psychiatry has led to major contributions in discovering gene by environment interactions, the importance of early adversity, and to recognition of the serious problem posed by treatment resistance. However, psychiatry's biologically reductionistic conceptual focus interferes with the development of a nuanced clinical perspective based on emerging knowledge that might help more treatment resistant patients become treatment responders. This article argues that recognition of the problem of treatment resistance in psychiatry creates a need for it to reconnect with the conceptual richness of psychoanalysis in order to improve patient care. Psychodynamic psychiatry is defined as the relevant intersection of psychiatry and psychoanalysis where this reconnection can occur. I will suggest selected aspects of psychoanalysis that are especially relevant to psychiatry in improving outcomes in work with treatment resistant patients.

The oncological patient in the palliative situation.

PubMed

Eychmueller, Steffen; Zwahlen, Diana; Fliedner, Monica

2014-01-01

Palliative care approaches the patient and his or her suffering with a biopsychosocial-spiritual model. Thus, it is the strength of palliative care to complement the diagnosis driven approach of medical cancer care by a problem and resources-based assessment, participatory care plan, and patient-directed interventions. Interventions need to reflect timely prognosis, target population (the patient, the family carer, the professional), and level of trust and remaining energy. In palliative care the relevance of psycho-oncological aspects in the care of the terminally ill is considerable in the understanding of the overall suffering of patients approaching death and their loved ones and in their care and support. There is little evidence to date in terms of clinical benefit of specific psycho-oncological interventions in the last months or weeks of life, but there is evidence on effects of stress reduction and reduced anxiety if locus of control can stay within the patient as long as possible. One major difficulty in psychosocial research at the end-of-life, however, is defining patient relevant outcomes.

Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics.

PubMed

Gibson, Glenn R; Hutkins, Robert; Sanders, Mary Ellen; Prescott, Susan L; Reimer, Raylene A; Salminen, Seppo J; Scott, Karen; Stanton, Catherine; Swanson, Kelly S; Cani, Patrice D; Verbeke, Kristin; Reid, Gregor

2017-08-01

In December 2016, a panel of experts in microbiology, nutrition and clinical research was convened by the International Scientific Association for Probiotics and Prebiotics to review the definition and scope of prebiotics. Consistent with the original embodiment of prebiotics, but aware of the latest scientific and clinical developments, the panel updated the definition of a prebiotic: a substrate that is selectively utilized by host microorganisms conferring a health benefit. This definition expands the concept of prebiotics to possibly include non-carbohydrate substances, applications to body sites other than the gastrointestinal tract, and diverse categories other than food. The requirement for selective microbiota-mediated mechanisms was retained. Beneficial health effects must be documented for a substance to be considered a prebiotic. The consensus definition applies also to prebiotics for use by animals, in which microbiota-focused strategies to maintain health and prevent disease is as relevant as for humans. Ultimately, the goal of this Consensus Statement is to engender appropriate use of the term 'prebiotic' by relevant stakeholders so that consistency and clarity can be achieved in research reports, product marketing and regulatory oversight of the category. To this end, we have reviewed several aspects of prebiotic science including its development, health benefits and legislation.

Miniaturized Battery-Free Wireless Systems for Wearable Pulse Oximetry.

PubMed

Kim, Jeonghyun; Gutruf, Philipp; Chiarelli, Antonio M; Heo, Seung Yun; Cho, Kyoungyeon; Xie, Zhaoqian; Banks, Anthony; Han, Seungyoung; Jang, Kyung-In; Lee, Jung Woo; Lee, Kyu-Tae; Feng, Xue; Huang, Yonggang; Fabiani, Monica; Gratton, Gabriele; Paik, Ungyu; Rogers, John A

2017-01-05

Development of unconventional technologies for wireless collection, storage and analysis of quantitative, clinically relevant information on physiological status is of growing interest. Soft, biocompatible systems are widely regarded as important because they facilitate mounting on external (e.g. skin) and internal (e.g. heart, brain) surfaces of the body. Ultra-miniaturized, lightweight and battery-free devices have the potential to establish complementary options in bio-integration, where chronic interfaces (i.e. months) are possible on hard surfaces such as the fingernails and the teeth, with negligible risk for irritation or discomfort. Here we report materials and device concepts for flexible platforms that incorporate advanced optoelectronic functionality for applications in wireless capture and transmission of photoplethysmograms, including quantitative information on blood oxygenation, heart rate and heart rate variability. Specifically, reflectance pulse oximetry in conjunction with near-field communication (NFC) capabilities enables operation in thin, miniaturized flexible devices. Studies of the material aspects associated with the body interface, together with investigations of the radio frequency characteristics, the optoelectronic data acquisition approaches and the analysis methods capture all of the relevant engineering considerations. Demonstrations of operation on various locations of the body and quantitative comparisons to clinical gold standards establish the versatility and the measurement accuracy of these systems, respectively.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiología Intervencionista; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention).

PubMed

Rihal, Charanjit S; Naidu, Srihari S; Givertz, Michael M; Szeto, Wilson Y; Burke, James A; Kapur, Navin K; Kern, Morton; Garratt, Kirk N; Goldstein, James A; Dimas, Vivian; Tu, Thomas

2015-06-01

This article provides a brief summary of the relevant recommendations and references related to percutaneous mechanical circulatory support. The goal was to provide the clinician with concise, evidence-based contemporary recommendations, and the supporting documentation to encourage their application. The full text includes disclosure of all relevant relationships with industry for each writing committee member. A fundamental aspect of all expert consensus statements is that these carefully developed, evidence-based documents can neither encompass all clinical circumstances, nor replace the judgment of individual physicians in management of each patient. The science of medicine is rooted in evidence, and the art of medicine is based on the application of this evidence to the individual patient. This expert consensus statement has adhered to these principles for optimal management of patients requiring percutaneous mechanical circulatory support. © 2015 by The Society for Cardiovascular Angiography and Interventions, The American College of Cardiology Foundation, the Heart Failure Society of America, and The Society for Thoracic Surgery.

Longitudinal Relations between Personality Traits and Aspects of Identity Formation during Adolescence

ERIC Educational Resources Information Center

Hill, Patrick L.; Allemand, Mathias; Grob, Sabine Zehnder; Peng, Aristide; Morgenthaler, Christoph; Kappler, Christoph

2013-01-01

The current study focused on three aspects of identity development relevant to the adolescent years: being an authentic person, perceiving control over and consistency in one's environment, and having consistent expectations from close others. In a two-wave study of adolescents (n = 750), we examined how these aspects change over the course of a…

Healthcare professionals' agreement on clinical relevance of drug-related problems among elderly patients.

PubMed

Bech, Christine Flagstad; Frederiksen, Tine; Villesen, Christine Tilsted; Højsted, Jette; Nielsen, Per Rotbøll; Kjeldsen, Lene Juel; Nørgaard, Lotte Stig; Christrup, Lona Louring

2018-02-01

Background Disagreement among healthcare professionals on the clinical relevance of drug-related problems can lead to suboptimal treatment and increased healthcare costs. Elderly patients with chronic non-cancer pain and comorbidity are at increased risk of drug related problems compared to other patient groups due to complex medication regimes and transition of care. Objective To investigate the agreement among healthcare professionals on their classification of clinical relevance of drug-related problems in elderly patients with chronic non-cancer pain and comorbidity. Setting Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark. Method A pharmacist performed medication review on elderly patients with chronic non-cancer pain and comorbidity, identified their drug-related problems and classified these problems in accordance with an existing categorization system. A five-member clinical panel rated the drug-related problems' clinical relevance in accordance with a five-level rating scale, and their agreement was compared using Fleiss' κ. Main outcome measure Healthcare professionals' agreement on clinical relevance of drug related problems, using Fleiss' κ. Results Thirty patients were included in the study. A total of 162 drug related problems were identified, out of which 54% were of lower clinical relevance (level 0-2) and 46% of higher clinical relevance (level 3-4). Only slight agreement (κ = 0.12) was found between the panellists' classifications of clinical relevance using a five-level rating scale. Conclusion The clinical pharmacist identified drug related problems of lower and higher clinical relevance. Poor overall agreement on the severity of the drug related problems was found among the panelists.

geneCommittee: a web-based tool for extensively testing the discriminatory power of biologically relevant gene sets in microarray data classification.

PubMed

Reboiro-Jato, Miguel; Arrais, Joel P; Oliveira, José Luis; Fdez-Riverola, Florentino

2014-01-30

The diagnosis and prognosis of several diseases can be shortened through the use of different large-scale genome experiments. In this context, microarrays can generate expression data for a huge set of genes. However, to obtain solid statistical evidence from the resulting data, it is necessary to train and to validate many classification techniques in order to find the best discriminative method. This is a time-consuming process that normally depends on intricate statistical tools. geneCommittee is a web-based interactive tool for routinely evaluating the discriminative classification power of custom hypothesis in the form of biologically relevant gene sets. While the user can work with different gene set collections and several microarray data files to configure specific classification experiments, the tool is able to run several tests in parallel. Provided with a straightforward and intuitive interface, geneCommittee is able to render valuable information for diagnostic analyses and clinical management decisions based on systematically evaluating custom hypothesis over different data sets using complementary classifiers, a key aspect in clinical research. geneCommittee allows the enrichment of microarrays raw data with gene functional annotations, producing integrated datasets that simplify the construction of better discriminative hypothesis, and allows the creation of a set of complementary classifiers. The trained committees can then be used for clinical research and diagnosis. Full documentation including common use cases and guided analysis workflows is freely available at http://sing.ei.uvigo.es/GC/.

Evaluating Cardiovascular Health Disparities Using Estimated Race/Ethnicity: A Validation Study.

PubMed

Bykov, Katsiaryna; Franklin, Jessica M; Toscano, Michele; Rawlins, Wayne; Spettell, Claire M; McMahill-Walraven, Cheryl N; Shrank, William H; Choudhry, Niteesh K

2015-12-01

Methods of estimating race/ethnicity using administrative data are increasingly used to examine and target disparities; however, there has been no validation of these methods using clinically relevant outcomes. To evaluate the validity of the indirect method of race/ethnicity identification based on place of residence and surname for assessing clinically relevant outcomes. A total of 2387 participants in the Post-MI Free Rx Event and Economic Evaluation (MI FREEE) trial who had both self-reported and Bayesian Improved Surname Geocoding method (BISG)-estimated race/ethnicity information available. We used tests of interaction to compare differences in the effect of providing full drug coverage for post-MI medications on adherence and rates of major vascular events or revascularization for white and nonwhite patients based upon self-reported and indirect racial/ethnic assignment. The impact of full coverage on clinical events differed substantially when based upon self-identified race (HR=0.97 for whites, HR=0.65 for nonwhites; interaction P-value=0.05); however, it did not differ among race/ethnicity groups classified using indirect methods (HR=0.87 for white and nonwhites; interaction P-value=0.83). The impact on adherence was the same for self-reported and BISG-estimated race/ethnicity for 2 of the 3 medication classes studied. Quantitatively and qualitatively different results were obtained when indirectly estimated race/ethnicity was used, suggesting that these techniques may not accurately describe aspects of race/ethnicity related to actual health behaviors.

The recognition, assessment and management of dementing disorders: conclusions from the Canadian Consensus Conference on Dementia.

PubMed

Patterson, C J; Gauthier, S; Bergman, H; Cohen, C A; Feightner, J W; Feldman, H; Hogan, D B

1999-06-15

To develop evidence based consensus statements on which to build clinical practice guidelines for primary care physicians toward the recognition, assessment and management of dementing disorders and to disseminate and evaluate the impact of these statements and guidelines built on these statements. Structured approach to assessment, including recommended laboratory tests, choices for neuroimaging and referral, management of complications (especially behavioural problems and depression) and use of cognitive enhancing agents. POTENTIAL OUTCOMES: Consistent and improved clinical care of persons with dementia; cost containment by more selective use of laboratory investigations; neuroimaging and referrals; and appropriate use of cognitive enhancing agents. Authors of each background paper were entrusted to perform a literature search, discover additional relevant material, including references cited in retrieved articles, consult with other experts in the field and then synthesize information. Standard rules of evidence were applied. Based on this evidence, consensus statements were developed by a group of experts, guided by a steering committee of 8 individuals, from the areas of Neurology, Geriatric Medicine, Psychiatry, Family Medicine, Preventive Health Care and Health Care Systems. Recommendations have been developed with particular attention to the context of primary care, and are intended to support family physicians in their ongoing assessment and care of patients with dementia. BENEFITS HARM AND COSTS: Potential for improved clinical care of people with dementia. A dissemination and evaluation strategy will attempt to measure the impact of the recommendations. Forty-eight recommendations are offered that address the following aspects of dementia care: early recognition; importance of careful history and examination in making a positive diagnosis; essential laboratory tests; rules for neuroimaging and referral; disclosure of diagnosis; importance of monitoring and providing support to caregivers; cultural aspects; detection and treatment of depression; observation and management of behavioural disturbances; detection and reporting of unsafe motor vehicle driving; genetic factors and opportunities for preventing dementia; pharmacological treatment with particular emphasis on cognitive enhancing agents. Four other sets of consensus statement or guidelines have been published recently. These recommendations are generally congruent with our own consensus statements. The consensus statements have been endorsed by relevant bodies in Canada.

Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial.

PubMed

Costa, Matthew L; Achten, Juul; Parsons, Nick R; Rangan, Amar; Griffin, Damian; Tubeuf, Sandy; Lamb, Sarah E

2014-08-05

To compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius. A multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation. 18 trauma centres in the United Kingdom. 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction. Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws. validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient's experience of pain and disability to give a score out of 100. disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery. The baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was -1.3, 95% confidence interval -4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group. Contrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with Kirschner wires or volar locking plates. Kirschner wire fixation, however, is cheaper and quicker to perform. Current Controlled Trials ISCRTN 31379280. UKCRN 8956. © Costa et al 2014.

Iatrogenics in Orthodontics and its challenges.

PubMed

Barreto, Gustavo Mattos; Feitosa, Henrique Oliveira

2016-01-01

Orthodontics has gone through remarkable advances for those who practice it with dignity and clinical quality, such as the unprecedented number of patients treated of some type of iatrogenic problems (post-treatment root resorptions; occlusal plane changes; midline discrepancies, asymmetries, etc). Several questions may raise useful reflections about the constant increase of iatrogenics. What is causing it? Does it occur when dentists are properly trained? In legal terms, how can dentists accept these patients? How should they be orthodontically treated? What are the most common problems? This study analyzed and discussed relevant aspects to understand patients with iatrogenic problems and describe a simple and efficient approach to treat complex cases associated with orthodontic iatrogenics.

Iatrogenics in Orthodontics and its challenges

PubMed Central

Barreto, Gustavo Mattos; Feitosa, Henrique Oliveira

2016-01-01

ABSTRACT Introduction: Orthodontics has gone through remarkable advances for those who practice it with dignity and clinical quality, such as the unprecedented number of patients treated of some type of iatrogenic problems (post-treatment root resorptions; occlusal plane changes; midline discrepancies, asymmetries, etc). Several questions may raise useful reflections about the constant increase of iatrogenics. What is causing it? Does it occur when dentists are properly trained? In legal terms, how can dentists accept these patients? How should they be orthodontically treated? What are the most common problems? Objective: This study analyzed and discussed relevant aspects to understand patients with iatrogenic problems and describe a simple and efficient approach to treat complex cases associated with orthodontic iatrogenics. PMID:27901237

Developments in cognitive neuroscience: I. Conflict, compromise, and connectionism.

PubMed

Westen, Drew; Gabbard, Glen O

2002-01-01

The strength of psychoanalysis has always been its understanding of affect and motivation. Contemporary developments in cognitive neuroscience offer possibilities of integrating sophisticated, experimentally informed models of thought and memory with an understanding of dynamically and clinically meaningful processes. Aspects of contemporary theory and research in cognitive neuroscience are integrated with psychoanalytic theory and technique, particularly theories of conflict and compromise. After a description of evolving models of the mind in cognitive neuroscience, several issues relevant to psychoanalytic theory and practice are addressed. These include the nature of representations, the interaction of cognition and affect, and the mechanisms by which the mind unconsciously forges compromise solutions that best fit multiple cognitive and affective-motivational constraints.

Exercising arrhythmias and sudden cardiac death in horses: Review of the literature and comparative aspects.

PubMed

Navas de Solis, C

2016-07-01

Arrhythmias are common in equine athletes during and immediately after exercise. Many of these rhythm variations are not clinically relevant. In horses, a link between different exercising arrhythmias and poor performance or between exercising arrhythmias and sudden cardiac death (SCD) is strongly suspected but not fully understood or proven. SCD during races or competitions is rare, but has catastrophic consequences for the safety of the human partner and public perceptions of welfare during equestrian sports. This review summarises current knowledge of equine exercise arrhythmias and their implications in SCD and compares existing principles and recommendations for equine subjects with those for human athletes. © 2016 EVJ Ltd.

Practical Radiobiology for Proton Therapy Planning

NASA Astrophysics Data System (ADS)

Jones, Bleddyn

2017-12-01

Practical Radiobiology for Proton Therapy Planning covers the principles, advantages and potential pitfalls that occur in proton therapy, especially its radiobiological modelling applications. This book is intended to educate, inform and to stimulate further research questions. Additionally, it will help proton therapy centres when designing new treatments or when unintended errors or delays occur. The clear descriptions of useful equations for high LET particle beam applications, worked examples of many important clinical situations, and discussion of how proton therapy may be optimized are all important features of the text. This important book blends the relevant physics, biology and medical aspects of this multidisciplinary subject. Part of Series in Physics and Engineering in Medicine and Biology.

What does the 4th edition of the World Health Organization Classification of Head and Neck Tumors (2017) bring new about mucosal melanomas?

PubMed

Xavier Júnior, José Cândido Caldeira; Ocanha-Xavier, Juliana Polizel

2018-03-01

The recently published 4th Edition of the World Health Organization Classification of Head and Neck Tumors addresses the most relevant and updated aspects of tumor biology, including clinical presentation, histopathology, immunohistochemistry, and prognosis of head and neck tumors. The objective of the present study is to compare these updates to the 3rd edition of that book with regard to mucosal melanomas and to highlight the potential factors that differ those tumors from cutaneous melanomas. We observed progress in the understanding of oral and sinonasal mucosal melanomas, which also present themselves, in the molecular scope, differently form cutaneous melanomas.

Gliomatosis cerebri: A consensus summary report from the First International Gliomatosis cerebri Group Meeting, March 26-27, 2015, Paris, France.

PubMed

Greenfield, Jeffrey P; Castañeda Heredia, Alicia; George, Emilie; Kieran, Mark W; Morales La Madrid, Andres

2016-12-01

Gliomatosis cerebri (GC) is a universally fatal extensive and diffuse infiltration of brain parenchyma by a glial tumor. Many aspects of this phenomenon remain unknown. The First International Gliomatosis cerebri Group Meeting had the following goals: refine the clinical and radiologic diagnostic criteria for GC, suggest appropriate diagnostic procedures, standardize tissue manipulation for histologic and molecular characterization, and prioritize relevant preclinical projects. Also, general treatment recommendations were outlined for the pediatric population. Importantly, this meeting was the starting point for meaningful collaborative international research projects. This review is a consensus summary of discussions shared and conclusions derived from this meeting. © 2016 Wiley Periodicals, Inc.

Incidental findings in multislice computed tomography prior to transcatheter aortic valve implantation: frequency, clinical relevance and outcome.

PubMed

Trenkwalder, Teresa; Lahmann, Anna Lena; Nowicka, Magdalena; Pellegrini, Costanza; Rheude, Tobias; Mayr, N Patrick; Voss, Stephanie; Bleiziffer, Sabine; Lange, Rüdiger; Joner, Michael; Kasel, Albert M; Kastrati, Adnan; Schunkert, Heribert; Husser, Oliver; Hadamitzky, Martin; Hengstenberg, Christian

2018-02-21

Multislice computed tomography (MSCT) has emerged as the mainstay in patients planned for transcatheter aortic valve implantation (TAVI). Incidental findings (IF) in MSCT are common. However, the exact incidence, clinical relevance and further consequences of IF are unclear and it is controversial whether IF adversely affect patients' outcome. We analyzed MSCT data of 1050 patients screened for TAVI between January 2011 and December 2014. Median follow-up of patients was 20 months. In total, 3194 IF were identified, which were classified into clinically non-relevant IF (2872, 90%) and clinically relevant IF (322, 10%). In 25% of patients (258/1050) at least one clinically relevant IF was present. Age (80 ± 7 vs. 80 ± 7 years; p = 0.198) and EuroSCORE II (3.6% [2.1-5.7] vs. 3.6% [2.1-5.9]; p = 0.874) was similar between patients with and without a clinically relevant IF. TAVI was performed less frequently in patients with a clinically relevant IF (76% vs. 85%; p < 0.001), with more patients receiving surgical aortic valve replacement in that group (14% vs. 11%; p = 0.042), possibly due to the high rate of incidental aneurysms of the ascending aorta (n = 48). If TAVI was performed mortality did not differ (30-days: 4% vs. 3%; p = 0.339, 1-year: 11% vs. 14%; p = 0.226) between patients with and without a clinically relevant IF. Our study is the largest study to analyze prevalence, clinical relevance and therapeutic consequences of IF during screening for TAVI. IF in pre-procedural MSCT are common and clinically relevant in one-quarter of patients. However, these findings had no impact on overall mortality.

DWI-ASPECTS (Diffusion-Weighted Imaging-Alberta Stroke Program Early Computed Tomography Scores) and DWI-FLAIR (Diffusion-Weighted Imaging-Fluid Attenuated Inversion Recovery) Mismatch in Thrombectomy Candidates: An Intrarater and Interrater Agreement Study.

PubMed

Fahed, Robert; Lecler, Augustin; Sabben, Candice; Khoury, Naim; Ducroux, Célina; Chalumeau, Vanessa; Botta, Daniele; Kalsoum, Erwah; Boisseau, William; Duron, Loïc; Cabral, Dominique; Koskas, Patricia; Benaïssa, Azzedine; Koulakian, Hasmik; Obadia, Michael; Maïer, Benjamin; Weisenburger-Lile, David; Lapergue, Bertrand; Wang, Adrien; Redjem, Hocine; Ciccio, Gabriele; Smajda, Stanislas; Desilles, Jean-Philippe; Mazighi, Mikaël; Ben Maacha, Malek; Akkari, Inès; Zuber, Kevin; Blanc, Raphaël; Raymond, Jean; Piotin, Michel

2018-01-01

We aimed to study the intrarater and interrater agreement of clinicians attributing DWI-ASPECTS (Diffusion-Weighted Imaging-Alberta Stroke Program Early Computed Tomography Scores) and DWI-FLAIR (Diffusion-Weighted Imaging-Fluid Attenuated Inversion Recovery) mismatch in patients with acute ischemic stroke referred for mechanical thrombectomy. Eighteen raters independently scored anonymized magnetic resonance imaging scans of 30 participants from a multicentre thrombectomy trial, in 2 different reading sessions. Agreement was measured using Fleiss κ and Cohen κ statistics. Interrater agreement for DWI-ASPECTS was slight (κ=0.17 [0.14-0.21]). Four raters (22.2%) had a substantial (or higher) intrarater agreement. Dichotomization of the DWI-ASPECTS (0-5 versus 6-10 or 0-6 versus 7-10) increased the interrater agreement to a substantial level (κ=0.62 [0.48-0.75] and 0.68 [0.55-0.79], respectively) and more raters reached a substantial (or higher) intrarater agreement (17/18 raters [94.4%]). Interrater agreement for DWI-FLAIR mismatch was moderate (κ=0.43 [0.33-0.57]); 11 raters (61.1%) reached a substantial (or higher) intrarater agreement. Agreement between clinicians assessing DWI-ASPECTS and DWI-FLAIR mismatch may not be sufficient to make repeatable clinical decisions in mechanical thrombectomy. The dichotomization of the DWI-ASPECTS (0-5 versus 0-6 or 0-6 versus 7-10) improved interrater and intrarater agreement, however, its relevance for patients selection for mechanical thrombectomy needs to be validated in a randomized trial. © 2017 American Heart Association, Inc.

Effects of controlled-release formulations of atypical antipsychotics on functioning and quality of life of schizophrenic individuals.

PubMed

Ruiu, Stefania; Casu, Maria Antonietta; Casu, Gianluca; Piras, Sara; Marchese, Giorgio

2012-08-01

Controlled-release formulations of atypical antipsychotics have recently been introduced into clinical practice. Clinical studies have indicated that these new therapies induce meaningful improvements in the functioning and quality of life of schizophrenic individuals. The present analysis makes an attempt to address the clinical relevance of these studies and their contribution to the understanding of the mechanisms of action of these new drugs. A Medline search was done using the keywords 'antipsychotic', 'plasma level', 'quality of life' and 'functioning'. After reviewing the literature, it seems that symptom control and side effects may play a role in modulating the functioning and quality of life of schizophrenic individuals treated with controlled-release formulations of atypical antipsychotics. The analysis also highlights that these new drugs may possess peculiarities and similarities in regulating patient functioning. However, the low number of clinical analyses that have focused on these aspects of antipsychotic therapy limits the interpretation of the results. Additional comparative clinical trials are needed to evaluate how the pharmacokinetic/pharmacodynamic properties of antipsychotic drugs may modulate the functioning and quality of life of schizophrenic individuals, as well as to establish whether new clinical benefits may come from the use of these drugs in schizophrenia therapy.

Therapeutic risk management of the suicidal patient: augmenting clinical suicide risk assessment with structured instruments.

PubMed

Homaifar, Beeta; Matarazzo, Bridget; Wortzel, Hal S

2013-09-01

This column is the second in a series presenting a model for therapeutic risk management of the suicidal patient. As discussed in the first part of the series, the model involves several elements including augmenting clinical risk assessment with structured instruments, stratifying risk in terms of both severity and temporality, and developing and documenting a safety plan. This column explores in more detail how to augment clinical risk assessment with structured instruments. Unstructured clinical interviews have the potential to miss important aspects of suicide risk assessment. By augmenting the free-form clinical interview with structured instruments that demonstrate reliability and validity, a more nuanced and multifaceted approach to suicide risk assessment is achieved. Incorporating structured instruments into practice also serves a medicolegal function, since these instruments may become a living part of the medical record, establishing baseline levels of suicidal thoughts and behaviors and facilitating future clinical determinations regarding safety needs. We describe several instruments used in a multidisciplinary suicide consultation service, each of which has demonstrated relevance to suicide risk assessment and screening, ease of administration, and strong psychometric properties. In addition, we emphasize the importance of viewing suicide risk assessment as an ongoing process rather than as a singular event. Finally, we discuss special considerations in the evolving practice of risk assessment.

Actors involved in the regulation of clinical research: comparison of Finland to England, Canada, and the USA.

PubMed

Hemminki, Elina

2015-04-07

The relevance and quantity of clinical research has caused concern and regulation is claimed to hinder clinical research. This paper compares clinical research regulations in Finland to those of England, Canada, and the USA around 2010-2011. Several approaches and data sources were used, including semi- or unstructured interviews of experts. For the analysis, a theoretical framework was made, data from various sources was synthesized, and features of the systems were simplified and classified. The various specific names and terms used in the data were changed into general ones. Common structures for the regulation existed in all four countries, but the details and scope varied. The research regulated within the main system was determined by research type (Finland), the financer of the health system (England), or research site (Canada, USA). Only Finland had specific legislation on medical research. The overriding impression of the regulatory systems was one of complexity. All countries had extra regulation for drug research. The types of drug research covered varied from trials with unlicensed (new) products or new indications (USA and Canada), to all types of interventional drug research (England), where 'interventional' was interpreted broadly (Finland). The complexity of regulations had led to the creation of various big and small businesses to help researchers and sponsors. There was notable variation in the role played by the public research funder. The role played by health care was difficult to study and seemed to involve varying interests as researchers were also health care employees. Research ethics committees were important and their tasks also included aspects other than ethics. This study revealed that a comparison between countries can provide useful insights into the distinctive aspects of each country's system, as well as identifying common features that require international action.

[In-hospital stroke care in Catalonia [Spain]. Results of the "First Clinical Audit of Stroke. Catalonia, 2005/2006"].

PubMed

Abilleira, Sònia; Ribera, Aida; Sánchez, Emília; Roquer, Jaume; Duarte, Esther; Tresserras, Ricard; Gallofré, Miquel

2008-01-01

To determine the quality of in-hospital stroke care in public acute care hospitals in Catalonia before the implementation of a clinical practice guideline (CPG) on stroke by determining adherence to specific recommendations of the CPG. We retrospectively reviewed the case notes of consecutive patients with stroke (defined with ICD-9 codes: 431, 433.x1, 434.x1, and 436) admitted to 48 Catalan hospitals within the first half of 2005. Data were collected on indicators of the healthcare process selected on the basis of their scientific evidence and/or clinical relevance. The participating hospitals included 20, 40 or 60 stroke cases according to their annual stroke caseload. After random selection, up to 9.3% of all cases recruited at each study center were externally monitored to assess the quality of the data gathered. Indicators were grouped into six different dimensions related to distinct aspects of clinical practice. We analyzed data from 1,791 stroke cases (53.9% men, mean age: 75.6 [12.4] years). Overall inter-observer agreement was 0.7. Compliance with the six dimensions was as follows (mean percentage [95%CI]): quality of medical records, 78.5% (77.5-79.4); initial interventions, 92.4% (91.5-93.2); neurological assessment, 38.3% (37.3-39.3); assessment of rehabilitation needs, 44.9% (43.2-46.7); prevention and management of medical complications, 68.4% (66.9-70), and initial preventive measures, 78.9% (77.3-80.4). In the first half of 2005, in-hospital stroke care in Catalonia showed room for improvement particularly in aspects related to the neurological assessment and follow-up of patients and their rehabilitation process.

Tetracyclines in Food and Feedingstuffs: From Regulation to Analytical Methods, Bacterial Resistance, and Environmental and Health Implications

PubMed Central

Granados-Chinchilla, Fabio

2017-01-01

Antibiotics are widely used as growth promoters in animal husbandry; among them, the tetracyclines are a chemical group of relevance, due to their wide use in agriculture, surpassing in quantities applied almost every other antibiotic family. Seeing the considerable amounts of tetracyclines used worldwide, monitoring of these antibiotics is paramount. Advances must be made in the analysis of antibiotics to assess correct usage and dosage of tetracyclines in food and feedstuffs and possible residues in pertinent environmental samples. The tetracyclines are still considered a clinically relevant group of antibiotics, though dissemination of tolerance and resistance determinants have limited their use. This review focuses on four different aspects: (i) tetracyclines, usage, dosages, and regulatory issues that govern their food-related application, with particular attention to the prohibitions and restrictions that several countries have enforced in recent years by agencies from both the United States and the European Union, (ii) analytical methods for tetracyclines, determination, and residues thereof in feedstuffs and related matrices with an emphasis on the most relevant and novel techniques, including both screening and confirmatory methods, (iii) tetracycline resistance and tetracycline-resistant bacteria in feedstuff, and (iv) environmental and health risks accompanying the use of tetracyclines in animal nutrition. In the last two cases, we discuss the more relevant undesirable effects that tetracyclines exert over bacterial communities and nontarget species including unwanted effects in farmers. PMID:28168081

Image-Based Medical Expert Teleconsultation in Acute Care of Injuries. A Systematic Review of Effects on Information Accuracy, Diagnostic Validity, Clinical Outcome, and User Satisfaction

PubMed Central

Hasselberg, Marie; Beer, Netta; Blom, Lisa; Wallis, Lee A.; Laflamme, Lucie

2014-01-01

Objective To systematically review the literature on image-based telemedicine for medical expert consultation in acute care of injuries, considering system, user, and clinical aspects. Design Systematic review of peer-reviewed journal articles. Data sources Searches of five databases and in eligible articles, relevant reviews, and specialized peer-reviewed journals. Eligibility criteria Studies were included that covered teleconsultation systems based on image capture and transfer with the objective of seeking medical expertise for the diagnostic and treatment of acute injury care and that presented the evaluation of one or several aspects of the system based on empirical data. Studies of systems not under routine practice or including real-time interactive video conferencing were excluded. Method The procedures used in this review followed the PRISMA Statement. Predefined criteria were used for the assessment of the risk of bias. The DeLone and McLean Information System Success Model was used as a framework to synthesise the results according to system quality, user satisfaction, information quality and net benefits. All data extractions were done by at least two reviewers independently. Results Out of 331 articles, 24 were found eligible. Diagnostic validity and management outcomes were often studied; fewer studies focused on system quality and user satisfaction. Most systems were evaluated at a feasibility stage or during small-scale pilot testing. Although the results of the evaluations were generally positive, biases in the methodology of evaluation were concerning selection, performance and exclusion. Gold standards and statistical tests were not always used when assessing diagnostic validity and patient management. Conclusions Image-based telemedicine systems for injury emergency care tend to support valid diagnosis and influence patient management. The evidence relates to a few clinical fields, and has substantial methodological shortcomings. As in the case of telemedicine in general, user and system quality aspects are poorly documented, both of which affect scale up of such programs. PMID:24887257

Four aspects of the scope and quality of family planning services in US publicly funded health centers: Results from a survey of health center administrators.

PubMed

Carter, Marion W; Gavin, Loretta; Zapata, Lauren B; Bornstein, Marta; Mautone-Smith, Nancy; Moskosky, Susan B

2016-10-01

This study aims to describe aspects of the scope and quality of family planning services provided by US publicly funded health centers before the release of relevant federal recommendations. Using nationally representative survey data (N=1615), we describe four aspects of service delivery: family planning services provided, contraceptive methods provided onsite, written contraceptive counseling protocols and youth-friendly services. We created a count index for each issue and used multivariable ordered logistic regression to identify health center characteristics associated with scoring higher on each. Half of the sample received Title X funding and about a third each were a community health center or health department clinic. The vast majority reported frequently providing contraceptive services (89%) and STD services (87%) for women in the past 3 months. Service provision to males was substantially lower except for STD screening. A total of 63% and 48% of health centers provided hormonal IUDs and implants onsite in the past 3 months, respectively. Forty percent of health centers included all five recommended contraceptive counseling practices in written protocols. Of youth-friendly services, active promotion of confidential services was among the most commonly reported (83%); offering weekend/evening hours was among the least (42%). In multivariable analyses, receiving Title X funding, having larger volumes of family planning clients and being a Planned Parenthood clinic were associated with higher scores on most indices. Many services were consistent with the recommendations for providing quality family planning services, but there was room for improvement across domains and health centers types. As assessed in this paper, the scope and quality of these family planning services was relatively high, particularly among Planned Parenthood clinics and Title X-funded centers. However, results point to important areas for improvement. Future studies should assess change as implementation of recent family planning service recommendations continues. Published by Elsevier Inc.

TU-E-BRB-00: Deformable Image Registration: Is It Right for Your Clinic

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

2015-06-15

Deformable image registration (DIR) is developing rapidly and is poised to substantially improve dose fusion accuracy for adaptive and retreatment planning and motion management and PET fusion to enhance contour delineation for treatment planning. However, DIR dose warping accuracy is difficult to quantify, in general, and particularly difficult to do so on a patient-specific basis. As clinical DIR options become more widely available, there is an increased need to understand the implications of incorporating DIR into clinical workflow. Several groups have assessed DIR accuracy in clinically relevant scenarios, but no comprehensive review material is yet available. This session will alsomore » discuss aspects of the AAPM Task Group 132 on the Use of Image Registration and Data Fusion Algorithms and Techniques in Radiotherapy Treatment Planning official report, which provides recommendations for DIR clinical use. We will summarize and compare various commercial DIR software options, outline successful clinical techniques, show specific examples with discussion of appropriate and inappropriate applications of DIR, discuss the clinical implications of DIR, provide an overview of current DIR error analysis research, review QA options and research phantom development and present TG-132 recommendations. Learning Objectives: Compare/contrast commercial DIR software and QA options Overview clinical DIR workflow for retreatment To understand uncertainties introduced by DIR Review TG-132 proposed recommendations.« less

Enhancing clinical evidence by proactively building quality into clinical trials.

PubMed

Meeker-O'Connell, Ann; Glessner, Coleen; Behm, Mark; Mulinde, Jean; Roach, Nancy; Sweeney, Fergus; Tenaerts, Pamela; Landray, Martin J

2016-08-01

Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight. The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials ("quality-by-design"), such that trials are feasible to conduct and important errors are prevented rather than remediated. A working group evaluated aspects of trial design and oversight and developed the Clinical Trials Transformation Initiative quality-by-design principles document, outlining a series of factors generally relevant to the reliability of trial conclusions and to patient safety. These principles were then applied and further refined during a series of hands-on workshops to evaluate their utility in facilitating proactive, cross-functional dialogue, and decision-making about trial design and planning. Following these workshops, independent qualitative interviews were conducted with 19 workshop attendees to explore the potential challenges for implementing a quality-by-design approach to clinical trials. The Clinical Trials Transformation Initiative project team subsequently developed recommendations and an online resource guide to support implementation of this approach. The Clinical Trials Transformation Initiative quality-by-design principles provide a framework for assuring that clinical trials adequately safeguard participants and provide reliable information on which to make decisions on the effects of treatments. The quality-by-design workshops highlighted the value of active discussions incorporating the different perspectives within and external to an organization (e.g. clinical investigators, research site staff, and trial participants) in improving trial design. Workshop participants also recognized the value of focusing oversight on those aspects of the trial where errors would have a major impact on participant safety and reliability of results. Applying the Clinical Trials Transformation Initiative quality-by-design recommendations and principles should enable organizations to prioritize the most critical determinants of a trial's quality, identify non-essential activities that can be eliminated to streamline trial conduct and oversight, and formulate appropriate plans to define, avoid, mitigate, monitor, and address important errors. © The Author(s) 2016.

I-Maculaweb: A Tool to Support Data Reuse in Ophthalmology

PubMed Central

Bonetto, Monica; Nicolò, Massimo; Gazzarata, Roberta; Fraccaro, Paolo; Rosa, Raffaella; Musetti, Donatella; Musolino, Maria; Traverso, Carlo E.

2016-01-01

This paper intends to present a Web-based application to collect and manage clinical data and clinical trials together in a unique tool. I-maculaweb is a user-friendly Web-application designed to manage, share, and analyze clinical data from patients affected by degenerative and vascular diseases of the macula. The unique and innovative scientific and technological elements of this project are the integration with individual and population data, relevant for degenerative and vascular diseases of the macula. Clinical records can also be extracted for statistical purposes and used for clinical decision support systems. I-maculaweb is based on an existing multilevel and multiscale data management model, which includes general principles that are suitable for several different clinical domains. The database structure has been specifically built to respect laterality, a key aspect in ophthalmology. Users can add and manage patient records, follow-up visits, treatment, diagnoses, and clinical history. There are two different modalities to extract records: one for the patient’s own center, in which personal details are shown and the other for statistical purposes, where all center’s anonymized data are visible. The Web-platform allows effective management, sharing, and reuse of information within primary care and clinical research. Clear and precise clinical data will improve understanding of real-life management of degenerative and vascular diseases of the macula as well as increasing precise epidemiologic and statistical data. Furthermore, this Web-based application can be easily employed as an electronic clinical research file in clinical studies. PMID:27170913

Delivery should happen soon and my pain will be reduced: understanding women's perception of good delivery care in India.

PubMed

Bhattacharyya, Sanghita; Srivastava, Aradhana; Avan, Bilal Iqbal

2013-11-22

Understanding a woman's perspective and her needs during childbirth and addressing them as part of quality-improvement programmes can make delivery care safe, affordable, and respectful. It has been pointed out that the patient's judgement on the quality and goodness of care is indispensible to improving the management of healthcare systems. The objective of the study is to understand the aspects of care that women consider important during childbirth. Individual in-depth interviews (IDIs) and focus-group discussions (FGDs) with women who recently delivered were the techniques used. Seventeen IDIs and four FGDs were conducted in Jharkhand state in east India between January and March 2012. Women who had normal deliveries with live births at home and in primary health centres were included. To minimise recall bias, interviews were conducted within 42 days of childbirth. Using the transcripts of interviews, the data were analysed thematically. Aspects of care most commonly cited by women to be important were: availability of health providers and appropriate medical care (primarily drugs) in case of complications; emotional support; privacy; clean place after delivery; availability of transport to reach the institution; monetary incentives that exceed expenses; and prompt care. Other factors included kind interpersonal behaviour, cognitive support, faith in the provider's competence, and overall cleanliness of the facility and delivery room. Respondents belonging to low socio-economic strata with basic literacy levels might not understand appropriate clinical aspects of care, but they want care that is affordable and accessible, along with privacy and emotional support during delivery. The study highlighted that healthcare quality-improvement programmes in India need to include non-clinical aspects of care as women want to be treated humanely during delivery--they desire respectful treatment, privacy, and emotional support. Further research into maternal satisfaction could be made more policy relevant by assessing the relative strength of various factors in influencing maternal satisfaction; this could help in prioritising appropriate interventions for improved quality of care (QoC).

Hospital managers' need for information in decision-making--An interview study in nine European countries.

PubMed

Kidholm, Kristian; Ølholm, Anne Mette; Birk-Olsen, Mette; Cicchetti, Americo; Fure, Brynjar; Halmesmäki, Esa; Kahveci, Rabia; Kiivet, Raul-Allan; Wasserfallen, Jean-Blaise; Wild, Claudia; Sampietro-Colom, Laura

2015-11-01

Assessments of new health technologies in Europe are often made at the hospital level. However, the guidelines for health technology assessment (HTA), e.g. the EUnetHTA Core Model, are produced by national HTA organizations and focus on decision-making at the national level. This paper describes the results of an interview study with European hospital managers about their need for information when deciding about investments in new treatments. The study is part of the AdHopHTA project. Face-to-face, structured interviews were conducted with 53 hospital managers from nine European countries. The hospital managers identified the clinical, economic, safety and organizational aspects of new treatments as being the most relevant for decision-making. With regard to economic aspects, the hospital managers typically had a narrower focus on budget impact and reimbursement. In addition to the information included in traditional HTAs, hospital managers sometimes needed information on the political and strategic aspects of new treatments, in particular the relationship between the treatment and the strategic goals of the hospital. If further studies are able to verify our results, guidelines for hospital-based HTA should be altered to reflect the information needs of hospital managers when deciding about investments in new treatments. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Assessing decision quality in patient-centred care requires a preference-sensitive measure

PubMed Central

Kaltoft, Mette; Cunich, Michelle; Salkeld, Glenn; Dowie, Jack

2014-01-01

A theory-based instrument for measuring the quality of decisions made using any form of decision technology, including both decision-aided and unaided clinical consultations is required to enable person- and patient-centred care and to respond positively to individual heterogeneity in the value aspects of decision making. Current instruments using the term ‘decision quality’ have adopted a decision- and thus condition-specific approach. We argue that patient-centred care requires decision quality to be regarded as both preference-sensitive across multiple relevant criteria and generic across all conditions and decisions. MyDecisionQuality is grounded in prescriptive multi criteria decision analysis and employs a simple expected value algorithm to calculate a score for the quality of a decision that combines, in the clinical case, the patient’s individual preferences for eight quality criteria (expressed as importance weights) and their ratings of the decision just taken on each of these criteria (expressed as performance rates). It thus provides an index of decision quality that encompasses both these aspects. It also provides patients with help in prioritizing quality criteria for future decision making by calculating, for each criterion, the Incremental Value of Perfect Rating, that is, the increase in their decision quality score that would result if their performance rating on the criterion had been 100%, weightings unchanged. MyDecisionQuality, which is a web-based generic and preference-sensitive instrument, can constitute a key patient-reported measure of the quality of the decision-making process. It can provide the basis for future decision improvement, especially when the clinician (or other stakeholders) completes the equivalent instrument and the extent and nature of concordance and discordance can be established. Apart from its role in decision preparation and evaluation, it can also provide real time and relevant documentation for the patient’s record. PMID:24335587

Knowledge discovery for Deep Phenotyping serious mental illness from Electronic Mental Health records.

PubMed

Jackson, Richard; Patel, Rashmi; Velupillai, Sumithra; Gkotsis, George; Hoyle, David; Stewart, Robert

2018-01-01

Background: Deep Phenotyping is the precise and comprehensive analysis of phenotypic features in which the individual components of the phenotype are observed and described. In UK mental health clinical practice, most clinically relevant information is recorded as free text in the Electronic Health Record, and offers a granularity of information beyond what is expressed in most medical knowledge bases. The SNOMED CT nomenclature potentially offers the means to model such information at scale, yet given a sufficiently large body of clinical text collected over many years, it is difficult to identify the language that clinicians favour to express concepts. Methods: By utilising a large corpus of healthcare data, we sought to make use of semantic modelling and clustering techniques to represent the relationship between the clinical vocabulary of internationally recognised SMI symptoms and the preferred language used by clinicians within a care setting. We explore how such models can be used for discovering novel vocabulary relevant to the task of phenotyping Serious Mental Illness (SMI) with only a small amount of prior knowledge.  Results: 20 403 terms were derived and curated via a two stage methodology. The list was reduced to 557 putative concepts based on eliminating redundant information content. These were then organised into 9 distinct categories pertaining to different aspects of psychiatric assessment. 235 concepts were found to be expressions of putative clinical significance. Of these, 53 were identified having novel synonymy with existing SNOMED CT concepts. 106 had no mapping to SNOMED CT. Conclusions: We demonstrate a scalable approach to discovering new concepts of SMI symptomatology based on real-world clinical observation. Such approaches may offer the opportunity to consider broader manifestations of SMI symptomatology than is typically assessed via current diagnostic frameworks, and create the potential for enhancing nomenclatures such as SNOMED CT based on real-world expressions.

Motivation factors for suicidal behavior and their clinical relevance in admitted psychiatric patients.

PubMed

Hayashi, Naoki; Igarashi, Miyabi; Imai, Atsushi; Yoshizawa, Yuka; Asamura, Kaori; Ishikawa, Yoichi; Tokunaga, Taro; Ishimoto, Kayo; Tatebayashi, Yoshitaka; Harima, Hirohiko; Kumagai, Naoki; Ishii, Hidetoki; Okazaki, Yuji

2017-01-01

Suicidal behavior (SB) is a major, worldwide health concern. To date there is limited understanding of the associated motivational aspects which accompany this self-initiated conduct. To develop a method for identifying motivational features associated with SB by studying admitted psychiatric patients, and to examine their clinical relevance. By performing a factor analytic study using data obtained from a patient sample exhibiting high suicidality and a variety of SB methods, Motivations for SB Scale (MSBS) was constructed to measure the features. Data included assessments of DSM-IV psychiatric and personality disorders, suicide intent, depressive symptomatology, overt aggression, recent life events (RLEs) and methods of SB, collated from structured interviews. Association of identified features with clinical variables was examined by correlation analyses and MANCOVA. Factor analyses elicited a 4-factor solution composed of Interpersonal-testing (IT), Interpersonal-change (IC), Self-renunciation (SR) and Self-sustenance (SS). These factors were classified according to two distinctions, namely interpersonal vs. intra-personal directedness, and the level of assumed influence by SB or the relationship to prevailing emotions. Analyses revealed meaningful links between patient features and clinical variables. Interpersonal-motivations (IT and IC) were associated with overt aggression, low suicidality and RLE discord or conflict, while SR was associated with depression, high suicidality and RLE separation or death. Borderline personality disorder showed association with IC and SS. When self-strangulation was set as a reference SB method, self-cutting and overdose-taking were linked to IT and SS, respectively. The factors extracted in this study largely corresponded to factors from previous studies, implying that they may be useful in a wider clinical context. The association of these features with SB-related factors suggests that they constitute an integral part of the process leading to SB. These results provide a base for further research into clinical strategies for patient management and therapy.

Knowledge discovery for Deep Phenotyping serious mental illness from Electronic Mental Health records

PubMed Central

Jackson, Richard; Patel, Rashmi; Velupillai, Sumithra; Gkotsis, George; Hoyle, David; Stewart, Robert

2018-01-01

Background: Deep Phenotyping is the precise and comprehensive analysis of phenotypic features in which the individual components of the phenotype are observed and described. In UK mental health clinical practice, most clinically relevant information is recorded as free text in the Electronic Health Record, and offers a granularity of information beyond what is expressed in most medical knowledge bases. The SNOMED CT nomenclature potentially offers the means to model such information at scale, yet given a sufficiently large body of clinical text collected over many years, it is difficult to identify the language that clinicians favour to express concepts. Methods: By utilising a large corpus of healthcare data, we sought to make use of semantic modelling and clustering techniques to represent the relationship between the clinical vocabulary of internationally recognised SMI symptoms and the preferred language used by clinicians within a care setting. We explore how such models can be used for discovering novel vocabulary relevant to the task of phenotyping Serious Mental Illness (SMI) with only a small amount of prior knowledge.  Results: 20 403 terms were derived and curated via a two stage methodology. The list was reduced to 557 putative concepts based on eliminating redundant information content. These were then organised into 9 distinct categories pertaining to different aspects of psychiatric assessment. 235 concepts were found to be expressions of putative clinical significance. Of these, 53 were identified having novel synonymy with existing SNOMED CT concepts. 106 had no mapping to SNOMED CT. Conclusions: We demonstrate a scalable approach to discovering new concepts of SMI symptomatology based on real-world clinical observation. Such approaches may offer the opportunity to consider broader manifestations of SMI symptomatology than is typically assessed via current diagnostic frameworks, and create the potential for enhancing nomenclatures such as SNOMED CT based on real-world expressions. PMID:29899974

Quality of reporting of randomized clinical trials in implant dentistry. A systematic review on critical aspects in design, outcome assessment and clinical relevance.

PubMed

Cairo, Francesco; Sanz, Ignacio; Matesanz, Paula; Nieri, Michele; Pagliaro, Umberto

2012-02-01

The aim of this systematic review (SR) was to assess the quality of reporting randomized clinical trials (RCTs) in the field of implant dentistry, its evolution over time and the possible relations between quality items and reported outcomes. RCTs in implant dentistry were retrieved through electronic and hand searches. Risk of bias in individual studies was assessed focusing on study design, outcome assessment and clinical relevance. Associations between quality items and year of publication of RCTs or reporting of statistically significant outcomes were tested. Among the 495 originally screened manuscripts published from 1989 to April 2011, 276 RCTs were assessed in this SR; 59% of them were published between 2006 and 2011. RCTs were mainly parallel (65%), with a single centre (83%) and a superiority design (88%). Trials in implant dentistry showed several methodological flaws: only 37% showed a random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, only 12% performed a correct sample size calculation, the examiner was blind solely in 42% of studies where blinding was feasible. In addition, only 21% of RCTs declared operator experience and 31% reported patient-related outcomes. Many quality items improved over time. Allocation concealment at high risk of bias (p = 0.0125), no information on drop-out (p = 0.0318) and lack of CONSORT adherence (p = 0.0333) were associated with statistically significant reported outcomes. The overall quality of reporting of RCTs in implant dentistry is poor and only partially improved in the last years. Caution is suggested when interpreting these RCTs since risk of bias was associated with higher chance of reporting of statistically significant results. © 2012 John Wiley & Sons A/S.

Antiepileptic treatment in paediatric oncology--an interdisciplinary challenge.

PubMed

Tibussek, D; Distelmaier, F; Schönberger, S; Göbel, U; Mayatepek, E

2006-01-01

Epileptic seizures are a common and clinically relevant problem in paediatric oncology. Attributable to the heterogeneity of this group of patients and a number of possible comorbidities antiepileptic treatment in paediatric oncology poses a number of diagnostic and therapeutic challenges. This requires a close interdisciplinary approach to the seizing child or adolescent. A prompt and detailed diagnostic work-up is needed in every case in order to establish the diagnosis and, equally important, to detect secondary aetiological factors, e. g. epileptogenic drugs or any acute underlying pathology, such as metabolic or toxic encephalopathies, CNS-infections or cerebrovascular events. This might offer the opportunity for a specific causative treatment and thus prevent unnecessary long-term antiepileptic drug (AED) treatment. If AED treatment is initiated several aspects have to be taken into account. Most importantly, AEDs and chemotherapeutic drugs (CTDs) may interact. Depending on the comedication this may result in reduced tumour or seizure control or unexpected toxicity of AEDs or CTDs. Understanding these interactions will allow to anticipate clinically relevant adverse effects. AED may be further complicated by side-effects, some of them of particular concern for children or adolescents, such as cognitive effects, myelotoxicity, serious rashes, endocrinological disturbances, and many more. Beside critically questioning the need for AED treatment it is therefore important to prefer AED with a good safety-profile in this population. Enzyme-inducing and inhibiting AED should be avoided if possible. Preliminary studies indicate that gabapentin and levetiracetam may provide good options in terms of efficacy and safety. However, more properly designed clinical studies are warranted to raise the level of evidence for robust clinical recommendations. Until that time, clinicians will need to continue to question current policies and adapt their daily practice to evolving scientific data.

Lysophosphatidic Acid (LPA) Signaling in Human and Ruminant Reproductive Tract

PubMed Central

Wocławek-Potocka, Izabela; Rawińska, Paulina; Kowalczyk-Zieba, Ilona; Boruszewska, Dorota; Sinderewicz, Emilia; Waśniewski, Tomasz; Skarzynski, Dariusz Jan

2014-01-01

Lysophosphatidic acid (LPA) through activating its G protein-coupled receptors (LPAR 1–6) exerts diverse cellular effects that in turn influence several physiological processes including reproductive function of the female. Studies in various species of animals and also in humans have identified important roles for the receptor-mediated LPA signaling in multiple aspects of human and animal reproductive tract function. These aspects range from ovarian and uterine function, estrous cycle regulation, early embryo development, embryo implantation, decidualization to pregnancy maintenance and parturition. LPA signaling can also have pathological consequences, influencing aspects of endometriosis and reproductive tissue associated tumors. The review describes recent progress in LPA signaling research relevant to human and ruminant reproduction, pointing at the cow as a relevant model to study LPA influence on the human reproductive performance. PMID:24744506

Identification of aspects of functioning, disability and health relevant to patients experiencing vertigo: a qualitative study using the international classification of functioning, disability and health

PubMed Central

2012-01-01

Purpose Aims of this study were to identify aspects of functioning and health relevant to patients with vertigo expressed by ICF categories and to explore the potential of the ICF to describe the patient perspective in vertigo. Methods We conducted a series of qualitative semi-structured face-to-face interviews using a descriptive approach. Data was analyzed using the meaning condensation procedure and then linked to categories of the International Classification of Functioning, Disability and Health (ICF). Results From May to July 2010 12 interviews were carried out until saturation was reached. Four hundred and seventy-one single concepts were extracted which were linked to 142 different ICF categories. 40 of those belonged to the component body functions, 62 to the component activity and participation, and 40 to the component environmental factors. Besides the most prominent aspect “dizziness” most participants reported problems within “Emotional functions (b152), problems related to mobility and carrying out the daily routine. Almost all participants reported “Immediate family (e310)” as a relevant modifying environmental factor. Conclusions From the patients’ perspective, vertigo has impact on multifaceted aspects of functioning and disability, mainly body functions and activities and participation. Modifying contextual factors have to be taken into account to cover the complex interaction between the health condition of vertigo on the individuals’ daily life. The results of this study will contribute to developing standards for the measurement of functioning, disability and health relevant for patients suffering from vertigo. PMID:22738067

Receptor tyrosine kinase inhibitors as potent weapons in war against cancers.

PubMed

Sharma, P Sapra; Sharma, R; Tyagi, T

2009-01-01

Receptor Tyrosine Kinases class I (RTK class I, EGF receptor family) constitute a family of transmembrane proteins involved in various aspects of cell growth and survival and have been implicated in the initiation and progression of several types of human malignancies. Activation of EGFR may be because of overexpression, mutations resulting in constitutive activation, or autocrine expression of ligand. In contrast, activation of HER2 occurs mainly by overexpression, which leads to spontaneous homodimerization and activation of downstream signaling events in a ligand-independent manner. EGFR and HER2 have now been validated as a clinically relevant target, and several different types of agents inhibiting these receptors are currently in development. The EGFR inhibitors Erlotinib, Gefitinib, and Cetuximab have undergone extensive clinical testing and have established clinical activity in non small cell lung cancer (NSCLS) and other types of solid tumors. Several of the other erbB inhibitors are also undergoing advanced clinical testing, either alone or in combination with other agents. This review reports various inhibitors, natural, small molecules and monoclonal antibodies, along with their reported activities for various members of erbB family. It will highlight the potential for the development of novel anti-cancer molecules.

Developing a Clinical-Grade Cryopreservation Protocol for Human Testicular Tissue and Cells

PubMed Central

Pacchiarotti, Jason; Ramos, Thomas; Howerton, Kyle; Greilach, Scott; Zaragoza, Karina; Olmstead, Marnie; Izadyar, Fariborz

2013-01-01

Recent work in preservation of female fertility as well as new information on the nature of spermatogonial stem cells has prompted an investigation into the possibility of an effective clinical-grade procedure for the cryopreservation of testicular cells and/or tissue. Clinical-grade reagents, validated equipment, and protocols consistent with cGTP/cGMP standards were used in developing a procedure suitable for the safe and effective cryopreservation of human testicular cells and tissues. These procedures were designed to be compliant with the relevant FDA regulations. The procedure proved to effectively cryopreserve both testicular cells and tissue. The cryopreservation of testicular tissue was comparable in most aspects we measured to the cryopreservation of isolated cells, except that the viability of the cells from cryopreserved testicular tissue was found to be significantly higher. On the other hand, cryopreservation of cells is preferred for cell analysis, quality control, and sterility testing. This study demonstrates that testicular tissue and cells from sexual reassignment patients can be successfully cryopreserved with a clinical-grade procedure and important cell populations are not only preserved but also enriched by the process. Further studies will determine whether these findings from hormone-treated patients can be generalized to other patients. PMID:23509810

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

PubMed

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.

Differences in the clinical characteristics of adolescent depressive disorders.

PubMed

Karlsson, Linnea; Pelkonen, Mirjami; Heilä, Hannele; Holi, Matti; Kiviruusu, Olli; Tuisku, Virpi; Ruuttu, Titta; Marttunen, Mauri

2007-01-01

Our objective was to analyze differences in clinical characteristics and comorbidity between different types of adolescent depressive disorders. A sample of 218 consecutive adolescent (ages 13-19 years) psychiatric outpatients with depressive disorders was interviewed for DSM-IV Axis I and Axis II diagnoses. We obtained data by interviewing the adolescents themselves and collecting additional background information from the clinical records. Lifetime age of onset for depression, current episode duration, frequency of suicidal behavior, psychosocial impairment, and the number of current comorbid psychiatric disorders varied between adolescent depressive disorder categories. The type of co-occurring disorder was mainly consistent across depressive disorders. Minor depression and dysthymia (DY) presented as milder depressions, whereas bipolar depression (BPD) and double depression [DD; i.e., DY with superimposed major depressive disorder (MDD)] appeared as especially severe conditions. Only earlier lifetime onset distinguished recurrent MDD from first-episode MDD, and newly emergent MDD appeared to be as impairing as recurrent MDD. Adolescent depressive disorder categories differ in many clinically relevant aspects, with most differences reflecting a continuum of depression severity. Identification of bipolarity and the subgroup with DD seems especially warranted. First episode MDD should be considered as severe a disorder as recurring MDD. (c) 2006 Wiley-Liss, Inc.

Executive summary of management of prosthetic joint infections. Clinical practice guidelines by the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC).

PubMed

Ariza, Javier; Cobo, Javier; Baraia-Etxaburu, Josu; Benito, Natividad; Bori, Guillermo; Cabo, Javier; Corona, Pablo; Esteban, Jaime; Horcajada, Juan Pablo; Lora-Tamayo, Jaime; Murillo, Oscar; Palomino, Julián; Parra, Jorge; Pigrau, Carlos; Del Pozo, José Luis; Riera, Melchor; Rodríguez, Dolores; Sánchez-Somolinos, Mar; Soriano, Alex; Del Toro, M Dolores; de la Torre, Basilio

2017-03-01

The incidence of prosthetic joint infection (PJI) is expected to increase in the coming years. PJI has serious consequences for patients, and high costs for the health system. The complexity of these infections makes it necessary to organize the vast quantity of information published in the last several years. The indications for the choice of a given surgical strategy and the corresponding antimicrobial therapy are specifically reviewed. The authors selected clinically relevant questions and then reviewed the available literature in order to give recommendations according to a pre-determined level of scientific evidence. The more controversial aspects were debated, and the final composition was agreed at an ad hoc meeting. Before its final publication, the manuscript was made available online in order that all SEIMC members were able to read it and make comments and suggestions. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Computer vision syndrome-A common cause of unexplained visual symptoms in the modern era.

PubMed

Munshi, Sunil; Varghese, Ashley; Dhar-Munshi, Sushma

2017-07-01

The aim of this study was to assess the evidence and available literature on the clinical, pathogenetic, prognostic and therapeutic aspects of Computer vision syndrome. Information was collected from Medline, Embase & National Library of Medicine over the last 30 years up to March 2016. The bibliographies of relevant articles were searched for additional references. Patients with Computer vision syndrome present to a variety of different specialists, including General Practitioners, Neurologists, Stroke physicians and Ophthalmologists. While the condition is common, there is a poor awareness in the public and among health professionals. Recognising this condition in the clinic or in emergency situations like the TIA clinic is crucial. The implications are potentially huge in view of the extensive and widespread use of computers and visual display units. Greater public awareness of Computer vision syndrome and education of health professionals is vital. Preventive strategies should form part of work place ergonomics routinely. Prompt and correct recognition is important to allow management and avoid unnecessary treatments. © 2017 John Wiley & Sons Ltd.

Fundamentals in Biostatistics for Investigation in Pediatric Dentistry: Part II -Biostatistical Methods.

PubMed

Pozos-Guillén, Amaury; Ruiz-Rodríguez, Socorro; Garrocho-Rangel, Arturo

The main purpose of the second part of this series was to provide the reader with some basic aspects of the most common biostatistical methods employed in health sciences, in order to better understand the validity, significance and reliability of the results from any article on Pediatric Dentistry. Currently, as mentioned in the first paper, Pediatric Dentists need basic biostatistical knowledge to be able to apply it when critically appraise a dental article during the Evidence-based Dentistry (EBD) process, or when participating in the development of a clinical study with dental pediatric patients. The EBD process provides a systematic approach of collecting, review and analyze current and relevant published evidence about oral health care in order to answer a particular clinical question; then this evidence should be applied in everyday practice. This second report describes the most commonly used statistical methods for analyzing and interpret collected data, and the methodological criteria to be considered when choosing the most appropriate tests for a specific study. These are available to Pediatric Dentistry practicants interested in reading or designing original clinical or epidemiological studies.

Faculty perceptions of the strengths, weaknesses and future prospects of the current medical undergraduate experimental physiology curriculum in Gujarat, India.

PubMed

Paralikar, Swapnil; Shah, Chinmay

2015-01-01

Over the past several years, an opinion has emerged in India that the current practical curricula in medical schools fail to meet many of the objectives for which they were instituted. Hence, this study has assessed the perception of physiology faculty members regarding the current experimental physiology curriculum in one Indian state, Gujarat. The faculty were of the opinion that many of the topics currently taught in experimental physiology (amphibian nerve-muscle and heart muscle experiments) were outdated and clinically irrelevant: Therefore, the faculty advocated that duration of teaching time devoted to some of these topics should be reduced and topics with clinical relevance should be introduced at the undergraduate level. The faculty also felt that more emphasis should be laid on highlighting the clinical aspect related to each concept taught in experimental physiology . Moreover, a majority of faculty members were in favour of replacing the current practice in Gujarat of teaching experimental physiology only by explanation of graphs obtained from experiments conducted in the previous years, with computer assisted learning in small groups.

Management of high-risk Myeloma: an evidence-based review of treatment strategies.

PubMed

Lehners, Nicola; Hayden, Patrick J; Goldschmidt, Hartmut; Raab, Marc-Steffen

2016-08-01

Despite the progress made in the treatment of patients with multiple myeloma over recent decades, a significant cohort with high-risk disease as defined by specific clinical and genetic criteria continue to respond poorly to standard treatment. These patients represent a particular challenge to the treating physician and require early identification as well as personalized treatment strategies. In this review, we discuss the prognostic impact of adverse clinical, radiological and genetic factors, evaluate available scoring systems and highlight key aspects of the therapeutic management of high-risk myeloma. MEDLINE and recent scientific meetings' databases were searched for the keywords 'high-risk' and 'multiple myeloma' and relevant studies relating to both diagnostic and therapeutic approaches were identified. Expert commentary: A case is made for intensive induction using combinations of novel agents, early high-dose therapy supported by autologous stem cell transplantation and the widespread use of maintenance therapies. Novel therapeutic options, especially in the field of immunotherapy, are currently explored in clinical trials and have the potential to further improve outcomes for patients with high-risk multiple myeloma.

[Clinical research. XIII. Research design contribution in the structured revision of an article].

PubMed

Talavera, Juan O; Rivas-Ruiz, Rodolfo

2013-01-01

The quality of information obtained in accordance to research design is integrated to the revision structured in relation to the causality model, used in the article "Reduction in the Incidence of Nosocomial Pneumonia Poststroke by Using the 'Turn-mob' Program", which corresponds to a clinical trial design. Points to identify and analyze are ethical issues in order to safeguard the security and respect for patients, randomization that seek to create basal homogeneous groups, subjects with the same probability of receiving any of the maneuvers in comparison, with the same pre maneuver probability of adherence, and which facilitate the blinding of outcome measurement and the distribution between groups of subjects with the same probability of leaving the study for reasons beyond the maneuvers. Other aspects are the relativity of comparison, the blinding of the maneuver, the parallel application of comparative maneuver, early stopping, and analysis according to the degree of adherence. The analysis in accordance with the design is complementary, since it is done based on the architectural model of causality, and the statistical and clinical relevance consideration.

Clinical usefulness of blood metal measurements to assess the failure of metal-on-metal hip implants

PubMed Central

Sampson, Barry; Hart, Alister

2012-01-01

In April 2010, a Medicines and Healthcare Products Regulatory Agency safety alert concerning all metal-on-metal (MOM) hip replacements recommended measuring chromium and cobalt concentrations when managing patients with painful prostheses. The need for this review is illustrated by the recent surge in requests for these blood tests from orthopaedic surgeons following this alert. The aim is to provide guidance to laboratories in assessing these requests and advising clinicians on interpretation. First, we summarize the basic terminology regarding the types of hip replacements, with emphasis on the MOM type. Second, we describe the clinical concerns over implant-derived wear debris in the local tissues and distant sites. Analytical aspects of the measurement of the relevant metal ions and what factors affect the levels measured are discussed. The application of inductively coupled plasma mass spectrometry techniques to the measurement of these metals is considered in detail. The biological effects of metal wear products are summarized with local toxicity and systemic biological effects considered, including carcinogenicity, genotoxicity and systemic toxicity. Clinical cases are used to illustrate pertinent points. PMID:22155921

Feline dermatophytosis

PubMed Central

2014-01-01

Practical relevance: Dermatophytosis (ringworm) is a superficial fungal skin disease of cats that, depending on the geographic region and practice caseload, may be encountered uncommonly through to commonly. This is a self-curing disease in an immunocompetent cat. Global importance: Dermatophytosis is prevalent worldwide and is one of a number of zoonotic skin diseases that cat owners are at risk of contracting. Clinical challenges: Dermatophytosis causes non-specific signs of hair loss, erythema and scaling, making it a differential diagnosis for many skin diseases of cats. The fact that this disease is infectious and contagious, and does not have any one classic clinical presentation, makes knowledge of diagnostic tools important in detection. The veterinarian’s role is in early disease recognition and institution of appropriate therapy to hasten resolution of the disease. Aim: The focus of this article is to provide an update and review of the most pertinent aspects that may be helpful in the management of dermatophytosis in any single or multiple cat situation. Evidence base: Where appropriate, evidence from the literature is used to supplement a summary of the author’s clinical experience and research in feline dermatophytosis. PMID:24794038

Comparison of the cytotoxicity of clinically relevant cobalt-chromium and alumina ceramic wear particles in vitro.

PubMed

Germain, M A; Hatton, A; Williams, S; Matthews, J B; Stone, M H; Fisher, J; Ingham, E

2003-02-01

Concern over polyethylene wear particle induced aseptic loosening of metal-on-polyethylene hip prostheses has led to renewed interest in alternative materials such as metal-on-metal and alumina ceramic-on-alumina ceramic for total hip replacement. This study compared the effects of clinically relevant cobalt-chromium and alumina ceramic wear particles on the viability of U937 histiocytes and L929 fibroblasts in vitro. Clinically relevant cobalt-chromium wear particles were generated using a flat pin-on-plate tribometer. The mean size of the clinically relevant metal particles was 29.5+/-6.3 nm (range 5-200 nm). Clinically relevant alumina ceramic particles were generated in the Leeds MkII anatomical hip simulator from a Mittelmieier prosthesis using micro-separation motion. This produced particles with a bimodal size distribution. The majority (98%) of the clinically relevant alumina ceramic wear debris was 5-20 nm in size. The cytotoxicity of the clinically relevant wear particles was compared to commercially available cobalt-chromium (9.87 microm+/-5.67) and alumina ceramic (0.503+/-0.19 microm) particles. The effects of the particles on the cells over a 5 day period at different particle volume (microm(3)) to cell number ratios were tested and viability determined using ATP-Lite(TM). Clinically relevant cobalt-chromium particles 50 and 5 microm(3) per cell reduced the viability of U937 cells by 97% and 42% and reduced the viability of L929 cells by 95% and 73%, respectively. At 50 microm(3) per cell, the clinically relevant ceramic particles reduced U937 cell viability by 18%. None of the other concentrations of the clinically relevant particles were toxic. The commercial cobalt-chromium and alumina particles did not affect the viability of either the U937 histiocytes or the L929 fibroblasts.Thus at equivalent particle volumes the clinically relevant cobalt-chromium particles were more toxic then the alumina ceramic particles. This study has emphasised the fact that the nature, size and volume of particles are important in assessing biological effects of wear debris on cells in vitro.

Assessing healthcare professionals' experiences of integrated care: do surveys tell the full story?

PubMed

Stephenson, Matthew D; Campbell, Jared M; Lisy, Karolina; Aromataris, Edoardo C

2017-09-01

Integrated care is the combination of different healthcare services with the goal to provide comprehensive, seamless, effective and efficient patient care. Assessing the experiences of healthcare professionals (HCPs) is an important aspect when evaluating integrated care strategies. The aim of this rapid review was to investigate if quantitative surveys used to assess HCPs' experiences with integrated care capture all the aspects highlighted as being important in qualitative research, with a view to informing future survey development. The review considered all types of health professionals in primary care, and hospital and specialist services, with a specific focus on the provision of integrated care aimed at improving the patient journey. PubMed, CINAHL and grey literature sources were searched for relevant surveys/program evaluations and qualitative research studies. Full text articles deemed to be of relevance to the review were appraised for methodological quality using abridged critical appraisal instruments from the Joanna Briggs Institute. Data were extracted from included studies using standardized data extraction templates. Findings from included studies were grouped into domains based on similarity of meaning. Similarities and differences in the domains covered in quantitative surveys and those identified as being important in qualitative research were explored. A total of 37 studies (19 quantitative surveys, 14 qualitative studies and four mixed-method studies) were included in the review. A range of healthcare professions participated in the included studies, the majority being primary care providers. Common domains identified from quantitative surveys and qualitative studies included Communication, Agreement on Clear Roles and Responsibilities, Facilities, Information Systems, and Coordination of Care and Access. Qualitative research highlighted domains identified by HCPs as being relevant to their experiences with integrated care that have not routinely being surveyed, including Workload, Clear Leadership/Decision-Making, Management, Flexibility of Integrated Care Model, Engagement, Usefulness of Integrated Care and Collaboration, and Positive Impact/Clinical Benefits/Practice Level Benefits. There were several domains identified from qualitative research that are not routinely included in quantitative surveys to assess health professionals' experiences of integrated care. In addition, the qualitative findings suggest that the experiences of HCPs are often impacted by deeper aspects than those measured by existing surveys. Incorporation of targeted items within these domains in the design of surveys should enhance the capture of data that are relevant to the experiences of HCPs with integrated care, which may assist in more comprehensive evaluation and subsequent improvement of integrated care programs.

Electrically evoked compound action potentials artefact rejection by independent component analysis: procedure automation.

PubMed

Akhoun, Idrick; McKay, Colette; El-Deredy, Wael

2015-01-15

Independent-components-analysis (ICA) successfully separated electrically-evoked compound action potentials (ECAPs) from the stimulation artefact and noise (ECAP-ICA, Akhoun et al., 2013). This paper shows how to automate the ECAP-ICA artefact cancellation process. Raw-ECAPs without artefact rejection were consecutively recorded for each stimulation condition from at least 8 intra-cochlear electrodes. Firstly, amplifier-saturated recordings were discarded, and the data from different stimulus conditions (different current-levels) were concatenated temporally. The key aspect of the automation procedure was the sequential deductive source categorisation after ICA was applied with a restriction to 4 sources. The stereotypical aspect of the 4 sources enables their automatic classification as two artefact components, a noise and the sought ECAP based on theoretical and empirical considerations. The automatic procedure was tested using 8 cochlear implant (CI) users and one to four stimulus electrodes. The artefact and noise sources were successively identified and discarded, leaving the ECAP as the remaining source. The automated ECAP-ICA procedure successfully extracted the correct ECAPs compared to standard clinical forward masking paradigm in 22 out of 26 cases. ECAP-ICA does not require extracting the ECAP from a combination of distinct buffers as it is the case with regular methods. It is an alternative that does not have the possible bias of traditional artefact rejections such as alternate-polarity or forward-masking paradigms. The ECAP-ICA procedure bears clinical relevance, for example as the artefact rejection sub-module of automated ECAP-threshold detection techniques, which are common features of CI clinical fitting software. Copyright © 2014. Published by Elsevier B.V.

Biological and Clinical Aspects of Lanthanide Coordination Compounds

PubMed Central

Misra, Sudhindra N.; M., Indira Devi; Shukla, Ram S.

2004-01-01

The coordinating chemistry of lanthanides, relevant to the biological, biochemical and medical aspects, makes a significant contribution to understanding the basis of application of lanthanides, particularly in biological and medical systems. The importance of the applications of lanthanides, as an excellent diagnostic and prognostic probe in clinical diagnostics, and an anticancer material, is remarkably increasing. Lanthanide complexes based X-ray contrast imaging and lanthanide chelates based contrast enhancing agents for magnetic resonance imaging (MRI) are being excessively used in radiological analysis in our body systems. The most important property of the chelating agents, in lanthanide chelate complex, is its ability to alter the behaviour of lanthanide ion with which it binds in biological systems, and the chelation markedly modifies the biodistribution and excretion profile of the lanthanide ions. The chelating agents, especially aminopoly carboxylic acids, being hydrophilic, increase the proportion of their complex excreted from complexed lanthanide ion form biological systems. Lanthanide polyamino carboxylate-chelate complexes are used as contrast enhancing agents for Magnetic Resonance Imaging. Conjugation of antibodies and other tissue specific molecules to lanthanide chelates has led to a new type of specific MRI contrast agents and their conjugated MRI contrast agents with improved relaxivity, functioning in the body similar to drugs. Many specific features of contrast agent assisted MRI make it particularly effective for musculoskeletal and cerebrospinal imaging. Lanthanide-chelate contrast agents are effectively used in clinical diagnostic investigations involving cerebrospinal diseases and in evaluation of central nervous system. Chelated lanthanide complexes shift reagent aided 23Na NMR spectroscopic analysis is used in cellular, tissue and whole organ systems. PMID:18365075

Neuropathologic features of the hippocampus and amygdala in cats with familial spontaneous epilepsy.

PubMed

Yu, Yoshihiko; Hasegawa, Daisuke; Hamamoto, Yuji; Mizoguchi, Shunta; Kuwabara, Takayuki; Fujiwara-Igarashi, Aki; Tsuboi, Masaya; Chambers, James Ken; Fujita, Michio; Uchida, Kazuyuki

2018-03-01

OBJECTIVE To investigate epilepsy-related neuropathologic changes in cats of a familial spontaneous epileptic strain (ie, familial spontaneous epileptic cats [FSECs]). ANIMALS 6 FSECs, 9 age-matched unrelated healthy control cats, and 2 nonaffected (without clinical seizures)dams and 1 nonaffected sire of FSECs. PROCEDURES Immunohistochemical analyses were used to evaluate hippocampal sclerosis, amygdaloid sclerosis, mossy fiber sprouting, and granule cell pathological changes. Values were compared between FSECs and control cats. RESULTS Significantly fewer neurons without gliosis were detected in the third subregion of the cornu ammonis (CA) of the dorsal and ventral aspects of the hippocampus as well as the central nucleus of the amygdala in FSECs versus control cats. Gliosis without neuronal loss was also observed in the CA4 subregion of the ventral aspect of the hippocampus. No changes in mossy fiber sprouting and granule cell pathological changes were detected. Moreover, similar changes were observed in the dams and sire without clinical seizures, although to a lesser extent. CONCLUSIONS AND CLINICAL RELEVANCE Findings suggested that the lower numbers of neurons in the CA3 subregion of the hippocampus and the central nucleus of the amygdala were endophenotypes of familial spontaneous epilepsy in cats. In contrast to results of other veterinary medicine reports, severe epilepsy-related neuropathologic changes (eg, hippocampal sclerosis, amygdaloid sclerosis, mossy fiber sprouting, and granule cell pathological changes) were not detected in FSECs. Despite the use of a small number of cats with infrequent seizures, these findings contributed new insights on the pathophysiologic mechanisms of genetic-related epilepsy in cats.

Ultrasonographic evaluation of the canine urinary bladder following cystotomy for treatment of urolithiasis.

PubMed

Mariano, Abigail D; Penninck, Dominique G; Sutherland-Smith, James; Kudej, Raymond K

2018-05-01

OBJECTIVE To describe the ultrasonographic appearance of the urinary bladder incision site in dogs that underwent cystotomy for treatment of urolithiasis. DESIGN Prospective, longitudinal study. ANIMALS 18 client-owned dogs. PROCEDURES Dogs underwent urinary bladder ultrasonography at baseline (≤ 1 day before surgery) and at 1 day and approximately 2, 6, and 12 weeks after cystotomy for urocystolith removal. A baseline ratio between ventral (cystotomy site) and corresponding dorsal midline wall thickness was calculated and used to account for measurement variations attributable to bladder distension at subsequent visits. Patient signalment, weight, medications administered, urocystolith composition, and culture results were recorded. Clinical signs, reoccurrence of hyperechoic foci, and suture visualization were recorded at follow-up examinations. Variables were evaluated for association with cystotomy site thickening and resolution of thickening. RESULTS Median wall thickness at the ventral aspect of the bladder was significantly greater than that of the corresponding dorsal aspect at baseline. Cystotomy site thickening peaked 1 day after surgery and decreased at subsequent visits in a linear manner. Twelve weeks after surgery, 5 of 10 clinically normal dogs evaluated had persistent cystotomy site thickening. Eleven of 18 dogs had reoccurrence of hyperechoic foci within the bladder at some time during the study (median time to first detection, 17 days after surgery). CONCLUSIONS AND CLINICAL RELEVANCE Persistent cystotomy site thickening can be present up to 3 months after cystotomy for urolithiasis in dogs without lower urinary tract signs. Reoccurrence of hyperechoic foci in the bladder, although subclinical, was detected earlier and at a higher rate than anticipated.

Applicability of bioanalysis of multiple analytes in drug discovery and development: review of select case studies including assay development considerations.

PubMed

Srinivas, Nuggehally R

2006-05-01

The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development culminating in a marketing approval. Although the bioanalytical procedure(s) originally developed during the discovery stage may not necessarily be fit to support the drug development scenario, they may be suitably modified and validated, as deemed necessary. Several reviews have appeared over the years describing analytical approaches including various techniques, detection systems, automation tools that are available for an effective separation, enhanced selectivity and sensitivity for quantitation of many analytes. The intention of this review is to cover various key areas where analytical method development becomes necessary during different stages of drug discovery research and development process. The key areas covered in this article with relevant case studies include: (a) simultaneous assay for parent compound and metabolites that are purported to display pharmacological activity; (b) bioanalytical procedures for determination of multiple drugs in combating a disease; (c) analytical measurement of chirality aspects in the pharmacokinetics, metabolism and biotransformation investigations; (d) drug monitoring for therapeutic benefits and/or occupational hazard; (e) analysis of drugs from complex and/or less frequently used matrices; (f) analytical determination during in vitro experiments (metabolism and permeability related) and in situ intestinal perfusion experiments; (g) determination of a major metabolite as a surrogate for the parent molecule; (h) analytical approaches for universal determination of CYP450 probe substrates and metabolites; (i) analytical applicability to prodrug evaluations-simultaneous determination of prodrug, parent and metabolites; (j) quantitative determination of parent compound and/or phase II metabolite(s) via direct or indirect approaches; (k) applicability in analysis of multiple compounds in select disease areas and/or in clinically important drug-drug interaction studies. A tabular representation of select examples of analysis is provided covering areas of separation conditions, validation aspects and applicable conclusion. A limited discussion is provided on relevant aspects of the need for developing bioanalytical procedures for speedy drug discovery and development. Additionally, some key elements such as internal standard selection, likely issues of mass detection, matrix effect, chiral aspects etc. are provided for consideration during method development.

Ethics review in compassionate use.

PubMed

Borysowski, Jan; Ehni, Hans-Jörg; Górski, Andrzej

2017-07-24

Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particularly that approval by a research ethics committee (institutional review board) is a requirement for compassionate use in some countries (e.g. the US, Spain, and Italy), but not in others (e.g. Canada, the UK, France, and Germany). The main objective of this article is to present aspects of compassionate use that are important for the discussion of the role of research ethics committees in the review of compassionate use. These aspects include the nature of compassionate use, potential risks to patients associated with the use of drugs with unproven safety and efficacy, informed consent, physicians' qualifications, and patient selection criteria. Our analysis indicates that the arguments for mandatory review substantially outweigh the arguments to the contrary. Approval by a research ethics committee should be obligatory for compassionate use. The principal argument against mandatory ethical review of compassionate use is that it is primarily a kind of treatment rather than biomedical research. Nonetheless, compassionate use is different from standard clinical care and should be subject to review by research ethics committees. First, in practice, compassionate use often involves significant research aspects. Second, it is based on unapproved drugs with unproven safety and efficacy. Obtaining informed consent from patients seeking access to unapproved drugs on a compassionate use basis may also be difficult. Other important problems include the qualifications of the physician who is to perform treatment, and patient selection criteria.

Financial aspects of organ procurement from deceased donors in the USA-Relevance to xenotransplantation.

PubMed

Saari, Ryan J; Cooper, David K C

2017-07-01

When clinical xenotransplantation is introduced, the costs associated with acquisition of a genetically engineered pig organ are as yet unknown. How will these costs compare with those currently associated with the acquisition of deceased human organs? An understanding of the financial aspects of deceased organ and tissue procurement in the USA is therefore worthwhile. We have therefore attempted to review certain economic aspects of non-profit and for-profit organizations that provide cadaveric organs and/or tissues for purposes of transplantation into patients with end-stage organ failure, cellular deficiencies, or in need of reconstructive procedures. We briefly consider the laws, organizations, and business practices that govern the acquisition, processing, and/or distribution of cadaveric organs and tissues, and the economic implications of industry practices. In particular, we explore and highlight what we perceive as a lack of transparency and oversight with regard to financial practices, and we question whether donor families would be entirely happy with the business environment that has developed from their altruistic donations. Until xenotransplantation becomes established clinically, which will negate the need for any system of organ procurement and allocation, we suggest that those involved in organ and cell transplantation, as well as those who participate in reconstructive surgery, should take responsibility to ensure that the financial practices associated with procurement are transparent, and overseen/regulated by a responsible authority. We suggest the major transplant societies should take a lead in this respect. The ability to acquire a genetically engineered pig organ whenever required through a simple commercial transaction (as in the acquisition of a life-saving drug) will be greatly to the patient's benefit. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Practical guidelines for the diagnosis and treatment of obstructive sleep apnea syndrome].

PubMed

Nogueira, Facundo; Nigro, Carlos; Cambursano, Hugo; Borsini, Eduardo; Silio, Julio; Avila, Jorge

2013-01-01

Obstructive sleep apnoea syndrome (OSAS) is one of the most relevant chronic respiratory pathologies due to its high prevalence and impact in morbidity and mortality. In 2001, the Asociación Argentina de Medicina Respiratoria (AAMR) published the first Argentinean Consensus on Sleep-Related breathing Disorders. Since then, wide new scientific evidence has emerged, increasing significantly the knowledge about this pathology. According to this, the Sleep-Related breathing Disorders and Oxygen Therapy Section of the AAMR, decided to update its Consensus, developing this Practical Guidelines on Management of patients with OSAS. A working group was created with members belonging to the section, experts in OSAS. They extensively reviewed the literature and wrote these guidelines, orientated to practical resolution of clinical problems and giving answers to questions emerged from dealing with patients who suffer from this syndrome. The document defines OSAS and describes the diagnosis and severity criteria, as well as the risk factors, ways of presentation and epidemiology. Clinical consequences, mainly on cognition, cardiovascular system and metabolism are pointed out. Different diagnostic methods, with their indications and technical aspects for validation and interpretation are detailed. Finally, we describe therapeutic alternatives, as well as practical aspects of their implementation. The authors' aim was to generate an accessible tool for teaching and spreading the knowledge on these disorders, which have a great impact in public health.

Measuring psychological flexibility in medical students and residents: a psychometric analysis

PubMed Central

Palladino, Christie L.; Ange, Brittany; Richardson, Deborah S.; Casillas, Rhonda; Decker, Matt; Gillies, Ralph A.; House, Amy; Rollock, Michael; Salazar, William H.; Waller, Jennifer L.; Zeidan, Ronnie; Stepleman, Lara

2013-01-01

Purpose Psychological flexibility involves mindful awareness of our thoughts and feelings without allowing them to prohibit acting consistently with our values and may have important implications for patient-centered clinical care. Although psychological flexibility appears quite relevant to the training and development of health care providers, prior research has not evaluated measures of psychological flexibility in medical learners. Therefore, we investigated the validity of our learners’ responses to three measures related to psychological flexibility. Methods Fourth-year medical students and residents (n=275) completed three measures of overlapping aspects of psychological flexibility: (1) Acceptance and Action Questionnaire-II (AAQ-II); (2) Cognitive Fusion Questionnaire (CFQ); and (3) Mindful Attention and Awareness Questionnaire (MAAS). We evaluated five aspects of construct validity: content, response process, internal structure, relationship with other variables, and consequences. Results We found good internal consistency for responses on the AAQ (α=0.93), MAAS (α=0.92), and CFQ (α=0.95). Factor analyses demonstrated a reasonable fit to previously published factor structures. As expected, scores on all three measures were moderately correlated with one another and with a measure of life satisfaction (p<0.01). Conclusion Our findings provide preliminary evidence supporting validity of the psychological flexibility construct in a medical education sample. As psychological flexibility is a central concept underlying self-awareness, this work may have important implications for clinical training and practice. PMID:23948496

The instant blood-mediated inflammatory reaction characterized in hepatocyte transplantation.

PubMed

Gustafson, Elisabet K; Elgue, Graciela; Hughes, Robin D; Mitry, Ragai R; Sanchez, Javier; Haglund, Ulf; Meurling, Staffan; Dhawan, Anil; Korsgren, Olle; Nilsson, Bo

2011-03-27

Hepatocyte transplantation (HcTx) has proven to be a safe procedure, although the functional results have been unsatisfactory, probably due to insufficient engraftment or a loss of transplanted mass or function. In this study, we investigate whether hepatocytes in contact with blood induce an inflammatory reaction leading to, similar to what happens in clinical islet transplantation, an instant blood-mediated inflammatory reaction (IBMIR) resulting in an early loss of transplanted cells. By using an experimental model that mimics the portal vein blood flow, we could study different parameters reflecting the effects on the innate immunity elicited by hepatocytes in contact with ABO-matched human blood. We report that all aspects of the IBMIR such as platelet and granulocyte consumption, coagulation, and complement activation were demonstrated. Addition of various specific inhibitors of coagulation allowed us to clearly delineate the various stages of the hepatocyte-triggered IBMIR and show that the reaction was triggered by tissue factor. Analysis of a case of clinical HcTx showed that hepatocyte-induced IBMIR also occurs in vivo. Both the inflammatory and the coagulation aspects were controlled by low-molecular-weight dextran sulfate. Isolated hepatocytes in contact with blood induce the IBMIR in vitro, and there are indications that these events are also relevant in vivo. According to these findings, HcTx would benefit from controlling a wider range of signals from the innate immune system.

To test or not to test? Laboratory support for the diagnosis of Lyme borreliosis: a position paper of ESGBOR, the ESCMID study group for Lyme borreliosis.

PubMed

Dessau, R B; van Dam, A P; Fingerle, V; Gray, J; Hovius, J W; Hunfeld, K-P; Jaulhac, B; Kahl, O; Kristoferitsch, W; Lindgren, P-E; Markowicz, M; Mavin, S; Ornstein, K; Rupprecht, T; Stanek, G; Strle, F

2018-02-01

Lyme borreliosis (LB) is a tick-borne infection caused by Borrelia burgdorferi sensu lato. The most frequent clinical manifestations are erythema migrans and Lyme neuroborreliosis. Currently, a large volume of diagnostic testing for LB is reported, whereas the incidence of clinically relevant disease manifestations is low. This indicates overuse of diagnostic testing for LB with implications for patient care and cost-effective health management. The recommendations provided in this review are intended to support both the clinical diagnosis and initiatives for a more rational use of laboratory testing in patients with clinically suspected LB. This is a narrative review combining various aspects of the clinical and laboratory diagnosis with an educational purpose. The literature search was based on existing systematic reviews, national and international guidelines and supplemented with specific citations. The main recommendations according to current European case definitions for LB are as follows. Typical erythema migrans should be diagnosed clinically and does not require laboratory testing. The diagnosis of Lyme neuroborreliosis requires laboratory investigation of the spinal fluid including intrathecal antibody production, and the remaining disease manifestations require testing for serum antibodies to B. burgdorferi. Testing individuals with non-specific subjective symptoms is not recommended, because of a low positive predictive value. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Cognitive deficits caused by prefrontal cortical and hippocampal neural disinhibition.

PubMed

Bast, Tobias; Pezze, Marie; McGarrity, Stephanie

2017-10-01

We review recent evidence concerning the significance of inhibitory GABA transmission and of neural disinhibition, that is, deficient GABA transmission, within the prefrontal cortex and the hippocampus, for clinically relevant cognitive functions. Both regions support important cognitive functions, including attention and memory, and their dysfunction has been implicated in cognitive deficits characterizing neuropsychiatric disorders. GABAergic inhibition shapes cortico-hippocampal neural activity, and, recently, prefrontal and hippocampal neural disinhibition has emerged as a pathophysiological feature of major neuropsychiatric disorders, especially schizophrenia and age-related cognitive decline. Regional neural disinhibition, disrupting spatio-temporal control of neural activity and causing aberrant drive of projections, may disrupt processing within the disinhibited region and efferent regions. Recent studies in rats showed that prefrontal and hippocampal neural disinhibition (by local GABA antagonist microinfusion) dysregulates burst firing, which has been associated with important aspects of neural information processing. Using translational tests of clinically relevant cognitive functions, these studies showed that prefrontal and hippocampal neural disinhibition disrupts regional cognitive functions (including prefrontal attention and hippocampal memory function). Moreover, hippocampal neural disinhibition disrupted attentional performance, which does not require the hippocampus but requires prefrontal-striatal circuits modulated by the hippocampus. However, some prefrontal and hippocampal functions (including inhibitory response control) are spared by regional disinhibition. We consider conceptual implications of these findings, regarding the distinct relationships of distinct cognitive functions to prefrontal and hippocampal GABA tone and neural activity. Moreover, the findings support the proposition that prefrontal and hippocampal neural disinhibition contributes to clinically relevant cognitive deficits, and we consider pharmacological strategies for ameliorating cognitive deficits by rebalancing disinhibition-induced aberrant neural activity. Linked Articles This article is part of a themed section on Pharmacology of Cognition: a Panacea for Neuropsychiatric Disease? To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v174.19/issuetoc. © 2017 The British Pharmacological Society.

Logical Structure and the Composing Process.

ERIC Educational Resources Information Center

Russow, Lilly-Marlene

An important aspect of the composing process is the element of organization--the coherent development of ideas and considerations of relevance. Most investigations of this aspect have focused on prewriting behavior or on "heuristics,""frames," or other approaches that presuppose that organization is something imposed from the…

Biological Aspects of Anorexia Nervosa and Bulimia Nervosa.

ERIC Educational Resources Information Center

Kaplan, Allan S.; Woodside, D. Blake

1987-01-01

Reviews biological factors relevant to the understanding of anorexia nervosa and bulimia nervosa. Considers the physical presentation of these disorders; the medical complications of starvation, binging, and purging; and the cognitive and behavioral effects of starvation. Reviews neurophysiological and neurochemical aspects of these illnesses and…

Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update.

PubMed

Banholzer, Maria Longauer; Wandel, Christoph; Barrow, Paul; Mannino, Marie; Schmitt, Georg; Guérard, Melanie; Müller, Lutz; Greig, Gerard; Amemiya, Kenjie; Peck, Richard; Singer, Thomas; Doessegger, Lucette

2016-12-01

This is an update to our 2012 publication on clinical trial considerations on male contraception and collection of pregnancy information from female partner, after critical review of recent (draft) guidances released by the International Council for Harmonisation [ICH] the Clinical Trial Facilitation Group [CTFG] and the US Food & Drug Administration [FDA]. Relevant aspects of the new guidance documents are discussed in the context of male contraception and pregnancy reporting from female partner in clinical trials and the approach is updated accordingly. Genotoxicity The concept of a threshold is introduced using acceptable daily intake/permissible daily exposure to define genotoxicity requirements, hence highly effective contraception in order to avoid conception. The duration for highly effective contraception has been extended from 74 to 90 days from the end of relevant systemic exposure. Teratogenicity Pharmacokinetic considerations to estimate safety margins have been contextualized with regard to over- and underestimation of the risk of teratogenicity transmitted by a vaginal dose. The duration of male contraception after the last dose takes into account the end of relevant systemic exposure if measured, or a default period of five half-lives after last dose for small molecules and two half-lives for immunoglobulins (mAbs). Measures to prevent exposure of the conceptus via a vaginal dose apply to reproductively competent or vasectomized men, unless measurements fail to detect the compound in seminal fluid. Critical review of new guidance documents provides a comparison across approaches and resulted in an update of our previous publication. Separate algorithms for small molecules and monoclonal antibodies are proposed to guide the recommendations for contraception for male trial participants and pregnancy reporting from female partners. No male contraception is required if the dose is below a defined threshold for genotoxic concern applicable to small molecules. For men treated with teratogenic mAbs, condom use to prevent exposure of a potentially pregnant partner is unlikely to be recommended because of the minimal female exposure anticipated following a vaginal dose. The proposed safety margins for teratogenicity may evolve with further knowledge.

What patients' complaints and praise tell the health practitioner: implications for health care quality. A qualitative research study.

PubMed

Mattarozzi, Katia; Sfrisi, Fiamma; Caniglia, Filippo; De Palma, Alessandra; Martoni, Monica

2017-02-01

In order to identify which health care aspects play a role in patient satisfaction and quality of health care, the present study analyses a large number of instances of complaint and praise. One thousand two hundred and thirty-five instances of complaint and one thousand five hundred thirty-six of praise submitted from patients or other souces (i.e. a patient's family member or a legal representative) to a northern-Italian hospital were analysed. We adopted Reader and colleagues' (2014) patients' complaint taxonomy, in conjunction with a detailed content analysis of relationship and communication of information aspects. The most frequent causes of complaint concerned care system management (68.1%), particularly the time taken to access treatment, and relationship aspects (52.8%). The importance of relationship aspects was confirmed by the expression of gratitude through praise (89%). The most critical factor of the relationship domain was effective communication of information to the patient (39.3%). Frequently patients complained of: (i) having received information that was inconsistent with the truth, (ii) having had difficulty in obtaining information, and (iii) untimely communication of information. Clinical aspects did not seem to be the main factors that triggered a complaint (36,8%), and, when indicated, they were almost always associated with relationship issues. This study indicates that not only complaints, but also instances of praise, are a potentially important source of information regarding health care aspects that play a role in patient satisfaction and quality of care. Our findings underline the relevance of relationship aspects in determining patients' satisfaction with the care received. In particular, health practitioners should focus their attention on how information is understood, translated and applied by patients. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

A systematic review of the neurobiological aspects of memory in the aging process

PubMed Central

de Oliveira, Eduardo Moreira; Kissaki, Priscilla Tiemi; Ordonez, Tiago Nascimento; Lima-Silva, Thaís Bento

2011-01-01

A systematic review of the neuroanatomical literature was performed to determine the neuropharmacological aspects most relevant to the study of memory processes. Articles were retrieved using the search terms "biology of memory", "memory and aging", "memory impairment", "elderly and memory," and their equivalents in Portuguese. Of the studies surveyed, five studies dealt with epidemiological and demographic issues, 12 were clinical trials i.e. were based on testing and implementation of instruments in human subjects, 33 studies were basic research involving studies of mice, rats and non-human primates, and biochemical and in vitro trials and finally, 52 studies were literature reviews or book chapters which in our view, fell into this category. Conclusions The work sought to highlight which neural networks are most involved in processing information, as well as their location within brain regions and the way in which neurotransmitters interact with each other for the formation of these memories. Moreover, it was shown how memory changes during the normal human aging process, both positively and negatively, by analyzing the morphological alterations that occur in the brain of aging individuals. PMID:29213758

Cultural psychiatry: research strategies and future directions.

PubMed

Kirmayer, Laurence J; Ban, Lauren

2013-01-01

This chapter reviews some key aspects of current research in cultural psychiatry and explores future prospects. The first section discusses the multiple meanings of culture in the contemporary world and their relevance for understanding mental health and illness. The next section considers methodological strategies for unpacking the concept of culture and studying the impact of cultural variables, processes and contexts. Multiple methods are needed to address the many different components or dimensions of cultural identity and experience that constitute local worlds, ways of life or systems of knowledge. Quantitative and observational methods of clinical epidemiology and experimental science as well as qualitative ethnographic methods are needed to capture crucial aspects of culture as systems of meaning and practice. Emerging issues in cultural psychiatric research include: cultural variations in illness experience and expression; the situated nature of cognition and emotion; cultural configurations of self and personhood; concepts of mental disorder and mental health literacy; and the prospect of ecosocial models of health and culturally based interventions. The conclusion considers the implications of the emerging perspectives from cultural neuroscience for psychiatric theory and practice. Copyright © 2013 S. Karger AG, Basel.

Morning blood pressure surge: pathophysiology, clinical relevance and therapeutic aspects

PubMed Central

Bilo, Grzegorz; Grillo, Andrea; Guida, Valentina; Parati, Gianfranco

2018-01-01

Morning hours are the period of the day characterized by the highest incidence of major cardiovascular events including myocardial infarction, sudden death or stroke. They are also characterized by important neurohormonal changes, in particular, the activation of sympathetic nervous system which usually leads to a rapid increase in blood pressure (BP), known as morning blood pressure surge (MBPS). It was hypothesized that excessive MBPS may be causally involved in the pathogenesis of cardiovascular events occurring in the morning by inducing hemodynamic stress. A number of studies support an independent relationship of MBPS with organ damage, cerebrovascular complications and mortality, although some heterogeneity exists in the available evidence. This may be due to ethnic differences, methodological issues and the confounding relationship of MBPS with other features of 24-hour BP profile, such as nocturnal dipping or BP variability. Several studies are also available dealing with treatment effects on MBPS and indicating the importance of long-acting antihypertensive drugs in this regard. This paper provides an overview of pathophysiologic, methodological, prognostic and therapeutic aspects related to MBPS. PMID:29872338

Recommendations of the Spanish Societies of Radiation Oncology (SEOR), Nuclear Medicine & Molecular Imaging (SEMNiM), and Medical Physics (SEFM) on (18)F-FDG PET-CT for radiotherapy treatment planning.

PubMed

Caballero Perea, Begoña; Villegas, Antonio Cabrera; Rodríguez, José Miguel Delgado; Velloso, María José García; Vicente, Ana María García; Cabrerizo, Carlos Huerga; López, Rosa Morera; Romasanta, Luis Alberto Pérez; Beltrán, Moisés Sáez

2012-01-01

Positron emission tomography (PET) with (18)F-fluorodeoxyglucose (FDG) is a valuable tool for diagnosing and staging malignant lesions. The fusion of PET and computed tomography (CT) yields images that contain both metabolic and morphological information, which, taken together, have improved the diagnostic precision of PET in oncology. The main imaging modality for planning radiotherapy treatment is CT. However, PET-CT is an emerging modality for use in planning treatments because it allows for more accurate treatment volume definition. The use of PET-CT for treatment planning is highly complex, and protocols and standards for its use are still being developed. It seems probable that PET-CT will eventually replace current CT-based planning methods, but this will require a full understanding of the relevant technical aspects of PET-CT planning. The aim of the present document is to review these technical aspects and to provide recommendations for clinical use of this imaging modality in the radiotherapy planning process.

Prediction of brain tissue temperature using near-infrared spectroscopy.

PubMed

Holper, Lisa; Mitra, Subhabrata; Bale, Gemma; Robertson, Nicola; Tachtsidis, Ilias

2017-04-01

Broadband near-infrared spectroscopy (NIRS) can provide an endogenous indicator of tissue temperature based on the temperature dependence of the water absorption spectrum. We describe a first evaluation of the calibration and prediction of brain tissue temperature obtained during hypothermia in newborn piglets (animal dataset) and rewarming in newborn infants (human dataset) based on measured body (rectal) temperature. The calibration using partial least squares regression proved to be a reliable method to predict brain tissue temperature with respect to core body temperature in the wavelength interval of 720 to 880 nm with a strong mean predictive power of [Formula: see text] (animal dataset) and [Formula: see text] (human dataset). In addition, we applied regression receiver operating characteristic curves for the first time to evaluate the temperature prediction, which provided an overall mean error bias between NIRS predicted brain temperature and body temperature of [Formula: see text] (animal dataset) and [Formula: see text] (human dataset). We discuss main methodological aspects, particularly the well-known aspect of over- versus underestimation between brain and body temperature, which is relevant for potential clinical applications.

Recommendations of the Spanish Societies of Radiation Oncology (SEOR), Nuclear Medicine & Molecular Imaging (SEMNiM), and Medical Physics (SEFM) on 18F-FDG PET-CT for radiotherapy treatment planning

PubMed Central

Caballero Perea, Begoña; Villegas, Antonio Cabrera; Rodríguez, José Miguel Delgado; Velloso, María José García; Vicente, Ana María García; Cabrerizo, Carlos Huerga; López, Rosa Morera; Romasanta, Luis Alberto Pérez; Beltrán, Moisés Sáez

2012-01-01

Positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) is a valuable tool for diagnosing and staging malignant lesions. The fusion of PET and computed tomography (CT) yields images that contain both metabolic and morphological information, which, taken together, have improved the diagnostic precision of PET in oncology. The main imaging modality for planning radiotherapy treatment is CT. However, PET-CT is an emerging modality for use in planning treatments because it allows for more accurate treatment volume definition. The use of PET-CT for treatment planning is highly complex, and protocols and standards for its use are still being developed. It seems probable that PET-CT will eventually replace current CT-based planning methods, but this will require a full understanding of the relevant technical aspects of PET-CT planning. The aim of the present document is to review these technical aspects and to provide recommendations for clinical use of this imaging modality in the radiotherapy planning process. PMID:24377032

Legal aspects of the management of chronic pain.

PubMed

Mendelson, G; Mendelson, D

1991-11-04

To review the legal provisions which control the prescription of opioid analgesics in Australia, and to summarise the areas in which practitioners who treat patients with chronic pain may expect to become involved with the legal system. The relevant legislation was reviewed, and a selective review was undertaken of literature dealing with the legal aspects of pain and suffering which may form a basis for personal injury claims. Case law which deals with issues of consent to treatment was also examined. Statutory requirements which control the prescription of opioids were summarised. Leading cases on patient consent were discussed to clarify for the practitioner the principles which the Courts use in the assessment of the validity of the consent given by patients for treatment. The assessment of the pain patient involved in litigation was briefly discussed. The prescription and administration of opioid analgesics must be in accordance with the legislative provisions. Treatment options must be discussed and explained to patients so that valid consent can be obtained. Patients' questions must be answered in full, and documentation in the clinical record is required.

[Ethnographic approaches to research and intervention in mental health].

PubMed

Nunes, Mônica de Oliveira; de Torrenté, Maurice

2013-10-01

The specifics of ethnographic approaches to mental health research are examined, highlighting the motives why the type of knowledge produced by ethnography is relevant to the context of Psychiatric Reform and the biomedicalization of existence. The discussion is focused on interpretation-based ethnography in the field of mental health, stressing the theoretical and methodological foundations of a comprehensive form of apprehending the scope of mental health as an object akin to a clinic of the individual. The centrality of social and cultural aspects in the ethnographic approach and the inflexions mediated by the type of ethnographic methodological undertaking is stressed. Lastly, the ethnography of madness is seen as a fitting example that substantiates some of these characteristics. The contention is that accessing psychotic persons (and others who may speak about these experiences) from varied areas of their daily life, situated in their various social inscriptions, while confronting these interpretations with other interpretative dimensions of their social reality and within the logic linked to local psychologies, is a pertinent procedure, from whence certain aspects of an understanding of madness (or causes of its incomprehension) can emerge.

Connections between primary vaginismus and procreation: some observations from clinical practice.

PubMed

Drenth, J J; Andriessen, S; Heringa, M P; Mourits, M J; van de Wiel, H B; Weijmar Schultz, W C

1996-12-01

So far, the literature on vaginismus has mainly been contemplative. Quantitative data are scarce, while fertility and obstetrical aspects are almost never considered. In this article, these two aspects are addressed. A cohort of patients received a questionnaire, developed to obtain information about possible connections between the vaginistic reaction, the patient's treatment goals and, if relevant, obstetrical characteristics. Our data reveal that the desire to have a child is not a negative predictor for treatment outcome in terms of consummation. In some instances, however, self-insemination, as a bedroom procedure, is an effective treatment option to enable the couple to reach their fertility goal. Some women will conceive without intercourse experience; according to our data, delivery in this group is hardly more problematic than in a group of women who, after treatment for vaginismus, conceived by sexual intercourse. Having delivered a child may have a slightly positive effect on the capability to have intercourse, but only in a minority. Obstetricians should be aware that not infrequently, women give birth who suffer from severe penetration phobias.

Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

PubMed

Keefe, Richard S E; Kraemer, Helena C; Epstein, Robert S; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P; McNulty, James; Reed, Shelby D; Sanchez, Juan; Leon, Andrew C

2013-05-01

This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

To Live or to Die: Prosurvival Activity of PPARγ in Cancers

PubMed Central

Wang, Y. Lynn; Miao, Qi

2008-01-01

The role of PPARγ in tumorigenesis is controversial. In this article, we review and analyze literature from the past decade that highlights the potential proneoplastic activity of PPARγ. We discuss the following five aspects of the nuclear hormone receptor and its agonists: (1) relative expression of PPARγ in human tumor versus normal tissues; (2) receptor-dependent proneoplastic effects; (3) impact of PPARγ and its agonists on tumors in animal models; (4) clinical trials of thiazolidinediones (TZDs) in human malignancies; (5) TZDs as chemopreventive agents in epidemiology studies. The focus is placed on the most relevant in vivo animal models and human data. In vitro cell line studies are included only when the effects are shown to be dependent on the PPARγ receptor. PMID:18784849

Extracorporeal respiratory support in adult patients

PubMed Central

Romano, Thiago Gomes; Mendes, Pedro Vitale; Park, Marcelo; Costa, Eduardo Leite Vieira

2017-01-01

ABSTRACT In patients with severe respiratory failure, either hypoxemic or hypercapnic, life support with mechanical ventilation alone can be insufficient to meet their needs, especially if one tries to avoid ventilator settings that can cause injury to the lungs. In those patients, extracorporeal membrane oxygenation (ECMO), which is also very effective in removing carbon dioxide from the blood, can provide life support, allowing the application of protective lung ventilation. In this review article, we aim to explore some of the most relevant aspects of using ECMO for respiratory support. We discuss the history of respiratory support using ECMO in adults, as well as the clinical evidence; costs; indications; installation of the equipment; ventilator settings; daily care of the patient and the system; common troubleshooting; weaning; and discontinuation. PMID:28380189

Clinical, Molecular, and Genetic Characteristics of PAPA Syndrome: A Review

PubMed Central

Smith, Elisabeth J; Allantaz, Florence; Bennett, Lynda; Zhang, Dongping; Gao, Xiaochong; Wood, Geryl; Kastner, Daniel L; Punaro, Marilynn; Aksentijevich, Ivona; Pascual, Virginia; Wise, Carol A

2010-01-01

PAPA syndrome (Pyogenic Arthritis, Pyoderma gangrenosum, and Acne) is an autosomal dominant, hereditary auto-inflammatory disease arising from mutations in the PSTPIP1/CD2BP1 gene on chromosome 15q. These mutations produce a hyper-phosphorylated PSTPIP1 protein and alter its participation in activation of the “inflammasome” involved in interleukin-1 (IL-1β) production. Overproduction of IL-1β is a clear molecular feature of PAPA syndrome. Ongoing research is implicating other biochemical pathways that may be relevant to the distinct pyogenic inflammation of the skin and joints characteristic of this disease. This review summarizes the recent and rapidly accumulating knowledge on these molecular aspects of PAPA syndrome and related disorders. PMID:21532836

EG-VEGF: a key endocrine factor in placental development.

PubMed

Brouillet, Sophie; Hoffmann, Pascale; Feige, Jean-Jacques; Alfaidy, Nadia

2012-10-01

Endocrine gland-derived vascular endothelial growth factor (EG-VEGF), also named prokineticin 1, is the canonical member of the prokineticin family. Numerous reports suggest a direct involvement of this peptide in normal and pathological reproductive processes. Recent advances propose EG-VEGF as a key endocrine factor that controls many aspects of placental development and suggest its involvement in the development of preeclampsia (PE), the most threatening pathology of human pregnancy. This review describes the finely tuned action and regulation of EG-VEGF throughout human pregnancy, argues for its clinical relevance as a potential diagnostic marker of the onset of PE, and discusses future research directions for therapeutic targeting of EG-VEGF. Copyright © 2012 Elsevier Ltd. All rights reserved.

[Medical aspects of common non-lethal weapons].

PubMed

Kunz, Sebastian Niko; Grove, Christina; Monticelli, Fabio

2014-03-01

The development and provision of non-lethal weapons (NLW) allow military and law enforcement personnel to exploit gradual engagement in countering potentially hazardous threats. Chemical, kinetic and electrical weapons systems are used to curb violence in civilian crowds. With inappropriate usage, these technologies can cause potentially fatal injuries that are not only of clinical, but also of legal relevance. In this context, the practicing physician is faced with treatment as well as assessment issues of new forms of injuries. In order to assure medical care and to be able to draw competent expert's conclusions, a detailed knowledge of the medical effects of these NLW is necessary. The review at hand presents today's most popular NLW and gives an overview of their possible injury potential and required treatments.

Termination in cognitive-behavioral therapy with children, adolescents, and parents.

PubMed

Vidair, Hilary B; Feyijinmi, Grace O; Feindler, Eva L

2017-03-01

The process of terminating cognitive-behavioral therapy (CBT) with families has been largely neglected in the literature, with the limited research focused on premature termination. This article describes the natural termination process in CBT with children, adolescents, and their parents. Based on existing theories, we describe a cognitive-behavioral model for: (a) initiating and engaging in discussion of termination, (b) processing the termination of treatment and the therapeutic relationship, (c) key aspects of the termination process in the final session, and (d) the very end of the final session (saying goodbye). For each of the 4 components, we review relevant theories, provide clinical exchanges to demonstrate techniques, and provide related research support. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

A life course perspective on polycystic ovary syndrome

PubMed Central

Sanchez, Ninive

2014-01-01

Polycystic ovary syndrome (PCOS) is a major public health problem in the US. Worldwide, the public is largely unaware of the condition and health care providers do not seem to fully understand it. Research on PCOS has primarily focused on its etiology and clinical characteristics and less on the psychosocial aspects of human development associated with PCOS. This paper posits that a life course perspective provides a framework for further understanding the psychosocial experiences of women with PCOS and the contexts in which they live. The paper discusses how life course principles of human development, constraints on agency, interdependence of lives, time and place, and timing of events and experiences are relevant to the management of PCOS and prevention of its complications. PMID:24489477

Role of dermatology in pharmacogenomics: drug-induced skin injury.

PubMed

Borroni, Riccardo G

2015-01-01

Different individuals may respond diversely to the same drug, in terms of efficacy and toxicity. Adverse drug reactions cause about 6% of all hospital admissions and account for up to 9% of hospitalization costs. Drug-induced skin injury (DISI) is the most common presentation of adverse drug reactions, ranging from maculopapular eruptions to severe adverse cutaneous drug reactions (SCARs) with mortality of up to 40%. Specific genetic polymorphisms confer susceptibility to different types of DISI. Identifying patients genetically at risk for SCARs is one of the goals of pharmacogenomics. In this article, the aspects of clinical dermatology relevant to the pharmacogenetics of DISI are reviewed. Many SCARs are now preventable, with consequent reduction of morbidity, mortality and healthcare costs.

Student-initiated revision in child health.

PubMed

Alfaham, M; Gray, O P; Davies, D P

1994-03-01

Most teaching of child health in Cardiff takes place in block attachments of 8 weeks. There is an introductory seminar of 2 days followed by a 6-week clinical attachment in a district general hospital in Wales, and then a revision period of one week designed to help students formalize and structure their basic knowledge and to clarify aspects of child health which they may have had difficulty in understanding. The revision programme has to take into account: the short time available, the small number of teaching staff, the most relevant basic knowledge and active participation by the student. This paper describes how this week has been improved through the use of student-initiated revision (SIR). The students' appraisal of this revision and in particular SIR is presented.

Affinity-based biosensors as promising tools for gene doping detection.

PubMed

Minunni, Maria; Scarano, Simona; Mascini, Marco

2008-05-01

Innovative bioanalytical approaches can be foreseen as interesting means for solving relevant emerging problems in anti-doping control. Sport authorities fear that the newer form of doping, so-called gene doping, based on a misuse of gene therapy, will be undetectable and thus much less preventable. The World Anti-Doping Agency has already asked scientists to assist in finding ways to prevent and detect this newest kind of doping. In this Opinion article we discuss the main aspects of gene doping, from the putative target analytes to suitable sampling strategies. Moreover, we discuss the potential application of affinity sensing in this field, which so far has been successfully applied to a variety of analytical problems, from clinical diagnostics to food and environmental analysis.

A CRISPR toolbox to study virus–host interactions

PubMed Central

Puschnik, Andreas S.; Majzoub, Karim; Ooi, Yaw Shin; Carette, Jan E.

2018-01-01

Viruses depend on their hosts to complete their replication cycles; they exploit cellular receptors for entry and hijack cellular functions to replicate their genome, assemble progeny virions and spread. Recently, genome-scale CRISPR–Cas screens have been used to identify host factors that are required for virus replication, including the replication of clinically relevant viruses such as Zika virus, West Nile virus, dengue virus and hepatitis C virus. In this Review, we discuss the technical aspects of genome-scale knockout screens using CRISPR–Cas technology, and we compare these screens with alternative genetic screening technologies. The relative ease of use and reproducibility of CRISPR–Cas make it a powerful tool for probing virus–host interactions and for identifying new antiviral targets. PMID:28420884

Is humidification always necessary during noninvasive ventilation in the hospital?

PubMed

Branson, Richard D; Gentile, Michael A

2010-02-01

Noninvasive ventilation (NIV) is a standard of care for the treatment of exacerbation of chronic obstructive pulmonary disease, to prevent intubation and reduce morbidity and mortality. The need for humidification of NIV gas is controversial. Some unique aspects of NIV conspire to alter the delivered humidity and airway function. In the presence of air leaks, unidirectional air flow dries the airways and increases airway resistance. Patient comfort is also a critical issue, as tolerance of NIV is often tied to patient comfort. This paper provides the arguments for and against routine humidification during NIV in the hospital setting. Data from clinical research demonstrate the effects of delivered humidification on relevant physiologic variables. The impact of humidification on NIV success/failure remains speculative.

Biomechanical properties of the spinal cord: implications for tissue engineering and clinical translation.

PubMed

Bartlett, Richard D; Choi, David; Phillips, James B

2016-10-01

Spinal cord injury is a severely debilitating condition which can leave individuals paralyzed and suffering from autonomic dysfunction. Regenerative medicine may offer a promising solution to this problem. Previous research has focused primarily on exploring the cellular and biological aspects of the spinal cord, yet relatively little remains known about the biomechanical properties of spinal cord tissue. Given that a number of regenerative strategies aim to deliver cells and materials in the form of tissue-engineered therapies, understanding the biomechanical properties of host spinal cord tissue is important. We review the relevant biomechanical properties of spinal cord tissue and provide the baseline knowledge required to apply these important physical concepts to spinal cord tissue engineering.

Nutrition and skin.

PubMed

Pappas, Apostolos; Liakou, Aikaterini; Zouboulis, Christos C

2016-09-01

Nutrition has long been associated with skin health, including all of its possible aspects from beauty to its integrity and even the aging process. Multiple pathways within skin biology are associated with the onset and clinical course of various common skin diseases, such as acne, atopic dermatitis, aging, or even photoprotection. These conditions have been shown to be critically affected by nutritional patterns and dietary interventions where well-documented studies have demonstrated beneficial effects of essential nutrients on impaired skin structural and functional integrity and have restored skin appearance and health. Although the subject could be vast, the intention of this review is to provide the most relevant and the most well-documented information on the role of nutrition in common skin conditions and its impact on skin biology.

[Brief on the standardization of the practitioner's posture in acupuncture operation].

PubMed

Lu, Yonghui

2015-07-01

To discuss the standardization of the practitioner's posture in acupuncture operation. Based on the relevant discussion on 'way to holding needle' recorded in Lingshu (Miraculous Pivot) and in association with the clinical acupuncture practice, it was required to standardize the practitioner's posture in acupuncture operation in reference to Lingshu (Miraculous Pivot). The standard standing posture of the practitioner is the precondition of acupuncture operation; the standard holding needle with the puncture hand is the key to the exercise of acupuncture technique and the regular standing orientation is the need of acupuncture operation. The three aspects are complemented each other, which is the coordinative procedure in acupuncture operation and enable the practitioner's high concentration with the body, qi and mind involved.

Hybrid nanosensor for colorimetric and ultrasensitive detection of nuclease contaminations

NASA Astrophysics Data System (ADS)

Cecere, Paola; Valentini, Paola; Pompa, Pier Paolo

2016-04-01

Nucleases are ubiquitous enzymes that degrade DNA or RNA, thus they can prejudice the good outcome of molecular biology experiments involving nucleic acids. We propose a colorimetric test for the naked-eye detection of nuclease contaminations. The system uses an hybrid nanosensor, based on gold nanoparticles functionalized with DNA probes. Our assay is rapid, instrument-free, simple and low-cost. Moreover, it reaches sensitivity equal or better than those of commercial kits, and presents a lot of advantageous aspects. Therefore, it is very competitive, with a real market potential. This test will be relevant in routine process monitoring in scientific laboratories, and in quality control in clinical laboratories and industrial processes, allowing the simultaneous detection of nucleases with different substrate specificities and large-scale screening.

PARP inhibition causes premature loss of cohesion in cancer cells

PubMed Central

Kukolj, Eva; Kaufmann, Tanja; Dick, Amalie E.; Zeillinger, Robert; Gerlich, Daniel W.; Slade, Dea

2017-01-01

Poly(ADP-ribose) polymerases (PARPs) regulate various aspects of cellular function including mitotic progression. Although PARP inhibitors have been undergoing various clinical trials and the PARP1/2 inhibitor olaparib was approved as monotherapy for BRCA-mutated ovarian cancer, their mode of action in killing tumour cells is not fully understood. We investigated the effect of PARP inhibition on mitosis in cancerous (cervical, ovary, breast and osteosarcoma) and non-cancerous cells by live-cell imaging. The clinically relevant inhibitor olaparib induced strong perturbations in mitosis, including problems with chromosome alignment at the metaphase plate, anaphase delay, and premature loss of cohesion (cohesion fatigue) after a prolonged metaphase arrest, resulting in sister chromatid scattering. PARP1 and PARP2 depletion suppressed the phenotype while PARP2 overexpression enhanced it, suggesting that olaparib-bound PARP1 and PARP2 rather than the lack of catalytic activity causes this phenotype. Olaparib-induced mitotic chromatid scattering was observed in various cancer cell lines with increased protein levels of PARP1 and PARP2, but not in non-cancer or cancer cell lines that expressed lower levels of PARP1 or PARP2. Interestingly, the sister chromatid scattering phenotype occurred only when olaparib was added during the S-phase preceding mitosis, suggesting that PARP1 and PARP2 entrapment at replication forks impairs sister chromatid cohesion. Clinically relevant DNA-damaging agents that impair replication progression such as topoisomerase inhibitors and cisplatin were also found to induce sister chromatid scattering and metaphase plate alignment problems, suggesting that these mitotic phenotypes are a common outcome of replication perturbation. PMID:29262611

Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis.

PubMed

Sabatino, A; Regolisti, G; Karupaiah, T; Sahathevan, S; Sadu Singh, B K; Khor, B H; Salhab, N; Karavetian, M; Cupisti, A; Fiaccadori, E

2017-06-01

Protein-Energy Wasting (PEW) is the depletion of protein/energy stores observed in the most advanced stages of Chronic Kidney Disease (CKD). PEW is highly prevalent among patients on chronic dialysis, and is associated with adverse clinical outcomes, high morbidity/mortality rates and increased healthcare costs. This narrative review was aimed at exploring the pathophysiology of PEW in end-stage renal disease (ESRD) on hemodialysis. The main aspects of nutritional status evaluation, intervention and monitoring in this clinical setting were described, as well as the current approaches for the prevention and treatment of ESRD-related PEW. An exhaustive literature search was performed, in order to identify the relevant studies describing the epidemiology, pathogenesis, nutritional intervention and outcome of PEW in ESRD on hemodialysis. The pathogenesis of PEW is multifactorial. Loss of appetite, reduced intake of nutrients and altered lean body mass anabolism/catabolism play a key role. Nutritional approach to PEW should be based on a careful and periodic assessment of nutritional status and on timely dietary counseling. When protein and energy intakes are reduced, nutritional supplementation by means of specific oral formulations administered during the hemodialysis session may be the first-step intervention, and represents a valid nutritional approach to PEW prevention and treatment since it is easy, effective and safe. Omega-3 fatty acids and fibers, now included in commercially available preparations for renal patients, could lend relevant added value to macronutrient supplementation. When oral supplementation fails, intradialytic parenteral nutrition can be implemented in selected patients. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Pre-Operative Diet Impacts the Adipose Tissue Response to Surgical Trauma

PubMed Central

Nguyen, Binh; Tao, Ming; Yu, Peng; Mauro, Christine; Seidman, Michael A.; Wang, Yaoyu E.; Mitchell, James; Ozaki, C. Keith

2012-01-01

Background Short-term changes in pre-operative nutrition can have profound effects on surgery related outcomes such as ischemia reperfusions injury in pre-clinical models. Dietary interventions that lend protection against stress in animal models (e.g. fasting, dietary restriction [DR]) impact adipose tissue quality/quantity. Adipose tissue holds high surgical relevance due to its anatomic location and high tissue volume, and it is ubiquitously traumatized during surgery. Yet the response of adipose tissue to trauma under clinically relevant circumstances including dietary status remains poorly defined. We hypothesized that pre-operative diet alters the adipose tissue response to surgical trauma. Methods A novel mouse model of adipose tissue surgical trauma was employed. Dietary conditions (diet induced obesity [DIO], pre-operative DR) were modulated prior to application of surgical adipose tissue trauma in the context of clinically common scenarios (different ages, simulated bacterial wound contamination). Local/distant adipose tissue phenotypic responses were measured as represented by gene expression of inflammatory, tissue remodeling/growth, and metabolic markers. Results Surgical trauma had a profound effect on adipose tissue phenotype at the site of trauma. Milder but significant distal effects on non-traumatized adipose tissue were also observed. DIO exacerbated the inflammatory aspects of this response, and pre-operative DR tended to reverse these changes. Age and LPS-simulated bacterial contamination also impacted the adipose tissue response to trauma, with young adult animals and LPS treatment exacerbating the proinflammatory response. Conclusions Surgical trauma dramatically impacts both local and distal adipose tissue biology. Short-term pre-operative DR may offer a strategy to attenuate this response. PMID:23274098

Acute Stress Symptoms in Children: Results From an International Data Archive

PubMed Central

Kassam-Adams, Nancy; Palmieri, Patrick A.; Rork, Kristine; Delahanty, Douglas L.; Kenardy, Justin; Kohser, Kristen L.; Landolt, Markus A.; Le Brocque, Robyne; Marsac, Meghan L.; Meiser-Stedman, Richard; Nixon, Reginald D. V.; Bui, Eric; McGrath, Caitlin

2012-01-01

Objective To describe the prevalence of acute stress disorder (ASD) symptoms and examine proposed DSM-5 symptom criteria in relation to concurrent functional impairment in children. Method From an international archive, datasets were identified which included assessment of acute traumatic stress reactions and concurrent impairment in children age 5 to 17. Data came from 15 studies conducted in the US, UK, Australia, and Switzerland with 1645 children. Dichotomized items were created to indicate the presence or absence of each of the 14 proposed ASD symptoms and functional impairment. The performance of a proposed diagnostic criterion (number of ASD symptoms required) was examined as a predictor of concurrent impairment. Results Each ASD symptom was endorsed by 14% to 51% of children; 41% reported clinically-relevant impairment. Children reported from 0 to 13 symptoms (mean = 3.6). Individual ASD symptoms were associated with greater likelihood of functional impairment. The DSM-5 proposed 8-symptom requirement was met by 202 (12.3%) children, and had low sensitivity (.25) in predicting concurrent clinically-relevant impairment. Requiring fewer symptoms (three to four) greatly improved sensitivity while maintaining moderate specificity. Conclusions This group of symptoms appears to capture aspects of traumatic stress reactions that can create distress and interfere with children’s ability to function in the acute post-trauma phase. Results provide a benchmark for comparison with adult samples; a smaller proportion of children met the 8-symptom criterion than reported for adults. Symptom requirements for the ASD diagnosis may need to be lowered to optimally identify children whose acute distress warrants clinical attention. PMID:22840552

Bottlenecks in the development of topical analgesics: molecule, formulation, dose-finding, and phase III design.

PubMed

Keppel Hesselink, Jan M; Kopsky, David J; Stahl, Stephen M

2017-01-01

Topical analgesics can be defined as topical formulations containing analgesics or co-analgesics. Since 2000, interest in such formulations has been on the rise. There are, however, four critical issues in the research and development phases of topical analgesics: 1) The selection of the active pharmaceutical ingredient. Analgesics and co-analgesics differ greatly in their mechanism of action, and it is required to find the most optimal fit between such mechanisms of action and the pathogenesis of the targeted (neuropathic) pain. 2) Issues concerning the optimized formulation. For relevant clinical efficacy, specific characteristics for the selected vehicle (eg, cream base or gel base) are required, depending on the physicochemical characteristics of the active pharmaceutical ingredient(s) to be delivered. 3) Well-designed phase II dose-finding studies are required, and, unfortunately, such trials are missing. In fact, we will demonstrate that underdosing is one of the major hurdles to detect meaningful and statistically relevant clinical effects of topical analgesics. 4) Selection of clinical end points and innovatively designed phase III trials. End point selection can make or break a trial. For instance, to include numbness together with tingling as a composite end point for neuropathic pain seems stretching the therapeutic impact of an analgesic too far. Given the fast onset of action of topical analgesics (usually within 30 minutes), enrichment designs might enhance the chances for success, as the placebo response might decrease. Topical analgesics may become promising inroads for the treatment of neuropathic pain, once sufficient attention is given to these four key aspects.

The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework.

PubMed

Cozzi, Emanuele; Tallacchini, Mariachiara; Flanagan, Enda B; Pierson, Richard N; Sykes, Megan; Vanderpool, Harold Y

2009-01-01

The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate. As most diabetic patients are not at risk of short-term mortality without islet transplantation, only a small subset of patients could currently be considered for any type of islet transplant. However, there are potential advantages to xenotransplantation that could result in a favorable benefit-over-harm determination for islet xenotransplantation in this subpopulation and ultimately in a broader population of diabetic patients. With regard to regulatory aspects, the key concepts underlying the development of the regulatory models in existence in the United States, Europe and New Zealand are discussed. Each of these models provides an example of a well-defined regulatory approach to ensure the initiation of well-regulated and ethically acceptable clinical islet xenotransplantation trials. At this stage, it becomes apparent that only a well-coordinated international effort such as that initiated by the World Health Organization, aimed at harmonizing xenotransplantation procedures according to the highest ethical and regulatory standards on a global scale, will enable the initiation of clinical xenotransplantation trials under the best auspices for its success and minimize any risk of failure.

Message Processing Research from Psychology to Communication.

ERIC Educational Resources Information Center

Basil, Michael D.

Information processing theories have been very useful in psychology. The application of information processing literature to communication, however, requires definitions of audiences and definitions of messages relevant to information-processing theories. In order to establish the relevant aspect of audiences, a multiple-stage model of audiences…

What's Relevant in Classical Literature?

ERIC Educational Resources Information Center

Hickman, Sara

1970-01-01

Argues the relevance of various aspects of the Thebian trilogy, "The Iliad," The Odyssey," Great Expectations," and Hamlet" to the concerns of today's high school students; a paper presented at annual convention of National Council of Teachers of English (59th, Washington, D.C., November 29, 1969). (RD)

21 CFR 1271.75 - How do I screen a donor?

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Risk factors for, and clinical evidence of, relevant communicable disease agents and diseases... risk factors for and clinical evidence of relevant cell-associated communicable disease agents and... having either of the following: (1) A risk factor for or clinical evidence of any of the relevant...

Epidemiology of dietary nutrient intake in ESRD.

PubMed

Kovesdy, Csaba P; Shinaberger, Christian S; Kalantar-Zadeh, Kamyar

2010-01-01

Protein-energy wasting (PEW) is one of the strongest risk factors of adverse outcomes in patients with chronic kidney disease including those with end-stage renal disease (ESRD) who undergo maintenance dialysis treatment. One important determinant of PEW in this patient population is an inadequate amount of protein and energy intake. Compounding the problem are the many qualitative nutritional deficiencies that arise because of the altered dietary habits of dialysis patients. Many of these alterations are iatrogenically induced, and albeit well intentioned, they could induce unintended harmful effects. In order to determine the best possible diet in ESRD patients, one must first understand the complex interplay between the quantity and quality of nutrient intake in these patients, and their impact on relevant clinical outcomes. We review available studies examining the association of nutritional intake with clinical outcomes in ESRD, stressing the complicated and often difficult-to-study inter-relationship between quantitative and qualitative aspects of nutrient intake in nutritional epidemiology. The currently recommended higher protein intake of 1.2 g/kg/day may be associated with a higher phosphorus and potassium burden and with worsening hyperphosphatemia and hyperkalemia, whereas dietary control of phosphorus and potassium by restricting protein intake may increase the risk of PEW. We assess the relevance of associative studies by examining the biologic plausibility of underlying mechanisms of action and emphasize areas in need of further research.

Flowable Resin Composites: A Systematic Review and Clinical Considerations

PubMed Central

Rodrigues, Jean C.

2015-01-01

Background Little is known about flowable composite materials. Most literature mentions conventional composite materials at large, giving minimal emphasis to flowables in particular. This paper briefly gives an in depth insight to the multiple facets of this versatile material. Aim To exclusively review the most salient features of flowable composite materials in comparison to conventional composites and to give clinicians a detailed understanding of the advantages, drawbacks, indications and contraindications based on composition and physical/mechanical properties. Methodology Data Sources: A thorough literature search from the year 1996 up to January 2015 was done on PubMed Central, The Cochrane Library, Science Direct, Wiley Online Library, and Google Scholar. Grey literature (pending patents, technical reports etc.) was also screened. The search terms used were “dental flowable resin composites”. Search Strategy After omitting the duplicates/repetitions, a total of 491 full text articles were assessed. As including all articles were out of the scope of this paper. Only relevant articles that fulfilled the reviewer’s objectives {mentioning indications, contraindications, applications, assessment of physical/mechanical/biological properties (in vitro/ in vivo /ex vivo)} were considered. A total of 92 full text articles were selected. Conclusion Flowable composites exhibit a variable composition and consequently variable mechanical/ physical properties. Clinicians must be aware of this aspect to make a proper material selection based on specific properties and indications of each material relevant to a particular clinical situation. PMID:26266238

Low-level laser therapy on MCF-7 cells: a micro-Fourier transform infrared spectroscopy study

NASA Astrophysics Data System (ADS)

Magrini, Taciana D.; dos Santos, Nathalia Villa; Milazzotto, Marcella Pecora; Cerchiaro, Giselle; da Silva Martinho, Herculano

2012-10-01

Low-level laser therapy (LLLT) is an emerging therapeutic approach for several clinical conditions. The clinical effects induced by LLLT presumably scale from photobiostimulation/photobioinhibition at the cellular level to the molecular level. The detailed mechanism underlying this effect remains unknown. This study quantifies some relevant aspects of LLLT related to molecular and cellular variations. Malignant breast cells (MCF-7) were exposed to spatially filtered light from a He-Ne laser (633 nm) with fluences of 5, 28.8, and 1000 mJ/cm2. The cell viability was evaluated by optical microscopy using the Trypan Blue viability test. The micro-Fourier transform infrared technique was employed to obtain the vibrational spectra of each experimental group (control and irradiated) and identify the relevant biochemical alterations that occurred due to the process. It was observed that the red light influenced the RNA, phosphate, and serine/threonine/tyrosine bands. We found that light can influence cell metabolism depending on the laser fluence. For 5 mJ/cm2, MCF-7 cells suffer bioinhibition with decreased metabolic rates. In contrast, for the 1 J/cm2 laser fluence, cells present biostimulation accompanied by a metabolic rate elevation. Surprisingly, at the intermediate fluence, 28.8 mJ/cm2, the metabolic rate is increased despite the absence of proliferative results. The data were interpreted within the retrograde signaling pathway mechanism activated with light irradiation.

Peak provoked craving: an alternative to smoking cue-reactivity.

PubMed

Sayette, Michael A; Tiffany, Stephen T

2013-06-01

Smoking cue-exposure research has provided a powerful tool for examining cravings in the laboratory. A key attraction of this method is that tightly controlled experimental procedures can model craving experiences that are presumed to relate to addiction. Despite its appeal, key assumptions underlying the clinical relevance of smoking cue-reactivity studies have been questioned recently. For both conceptual and methodological reasons it may be difficult to tease apart cue-based and abstinence-based cravings. Moreover, conventional cue-reactivity procedures typically generate levels of craving with only minimal clinical relevance. We argue here that sometimes it is unfeasible-and in some instances conceptually misguided-to disentangle abstinence-based and cued components of cigarette cravings. In light of the challenges associated with cue-reactivity research, we offer an alternative approach to smoking cue-exposure experimental research focusing on peak provoked craving (PPC) states. The PPC approach uses nicotine-deprived smokers and focuses on urges during smoking cue-exposure without subtracting out urge ratings during control cue or baseline assessments. This design relies on two factors found in many cue-exposure studies-nicotine deprivation and exposure to explicit smoking cues-which, when combined, can create powerful craving states. The PPC approach retains key aspects of the cue-exposure method, and in many circumstances may be a viable design for studies examining robust laboratory-induced cravings. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Systematic Review of Vitamin D and Hypertensive Disorders of Pregnancy

PubMed Central

O’Callaghan, Karen M.

2018-01-01

This narrative systematic review evaluates growing evidence of an association between low maternal vitamin D status and increased risk of hypertensive disorders. The inclusion of interventional, observational, and dietary studies on vitamin D and all hypertensive disorders of pregnancy is a novel aspect of this review, providing a unique contribution to an intensively-researched area that still lacks a definitive conclusion. To date, trial evidence supports a protective effect of combined vitamin D and calcium supplementation against preeclampsia. Conflicting data for an association of vitamin D with gestational hypertensive disorders in observational studies arises from a number of sources, including large heterogeneity between study designs, lack of adherence to standardized perinatal outcome definitions, variable quality of analytical data for 25-hydroxyvitamin D (25(OH)D), and inconsistent data reporting of vitamin D status. While evidence does appear to lean towards an increased risk of gestational hypertensive disorders at 25(OH)D concentrations <50 nmol/L, caution should be exercised with dosing in trials, given the lack of data on long-term safety. The possibility that a fairly narrow target range for circulating 25(OH)D for achievement of clinically-relevant improvements requires further exploration. As hypertension alone, and not preeclampsia specifically, limits intrauterine growth, evaluation of the relationship between vitamin D status and all terms of hypertension in pregnancy is a clinically relevant area for research and should be prioritised in future randomised trials. PMID:29494538

Systematic Review of Vitamin D and Hypertensive Disorders of Pregnancy.

PubMed

O'Callaghan, Karen M; Kiely, Mairead

2018-03-01

This narrative systematic review evaluates growing evidence of an association between low maternal vitamin D status and increased risk of hypertensive disorders. The inclusion of interventional, observational, and dietary studies on vitamin D and all hypertensive disorders of pregnancy is a novel aspect of this review, providing a unique contribution to an intensively-researched area that still lacks a definitive conclusion. To date, trial evidence supports a protective effect of combined vitamin D and calcium supplementation against preeclampsia. Conflicting data for an association of vitamin D with gestational hypertensive disorders in observational studies arises from a number of sources, including large heterogeneity between study designs, lack of adherence to standardized perinatal outcome definitions, variable quality of analytical data for 25-hydroxyvitamin D (25(OH)D), and inconsistent data reporting of vitamin D status. While evidence does appear to lean towards an increased risk of gestational hypertensive disorders at 25(OH)D concentrations <50 nmol/L, caution should be exercised with dosing in trials, given the lack of data on long-term safety. The possibility that a fairly narrow target range for circulating 25(OH)D for achievement of clinically-relevant improvements requires further exploration. As hypertension alone, and not preeclampsia specifically, limits intrauterine growth, evaluation of the relationship between vitamin D status and all terms of hypertension in pregnancy is a clinically relevant area for research and should be prioritised in future randomised trials.

[The Polish Task Force position statement on safety of biologic treatment with monoclonal antibodies and soluble receptors].

PubMed

Jahnz-Rozyk, Karina; Wiesik-Szewczyk, Ewa

2014-07-01

The introduction of biologic therapies for treatment in many fields of medicine such as rheumatology oncology, dermatology, hematology and allergology, became one of the most important achievements of the modem medicine. The first biological therapeutics have already reached patent expiration date and corresponding biosimilars were approved by EMA (European Medicine Agency) and FDA (Food and Drug Administration). Many more biosimilar products are currently under review for marketing authorization around the world. The approval of products similar, but not identical to already known innovative biologics, due to complexity of structure and manufacturing technology, stirs a lot of discussions regarding safety concerns related to differences in posttranslational processing and in immunogenicity between reference and biosimilar products, and relevance of these differences to the clinical practice. Critical issues involve extrapolation to different clinical indication, automatic substitution and switching. Despite EMA recommendation and advocacy for biosimilars, it is beyond this regulatory authority to establish definitive regulation for each EU member, which it is expected to be country related. The aim of the study was an attempt to define the stance regarding particular aspects of biological treatment conducted in Poland is undertaken. The Task Force of 13 experts involved in various aspects of biologic therapies in Poland was established. A modified Delphi voting was performed to achieve consensus regarding the most important aspects of biologic treatment in Poland, with particular concern of biosimilars. Ten final statements were discussed and voted upon. The statements cover general aspects of biosimilars including expected cost-benefit ratios, extrapolation of clinical indications, interchange switching, patient information and requirement of patient consent. The state of post marketing pharmacovigilance of biologics (innovative ones as well as biosimilars) was also discussed. The Task Force agreed that introduction of biosimilars is an important achievement in the biological therapies, with potential for reduction of treatment cost and increased treatment availability. Experts also agree that the safety of biological treatment should be monitored more carefully in Poland. Other discussed issues sparked more questions. There is no consensus among experts as to the automatic interchangeability of biosimilar and their innovative biopharmaceuticals. However, the switching might be acceptable in clinical practice on the case by case basis. There is an unmet need in Poland to create registry collecting data sufficient for assessment of safety and efficacy of both biosimilars and reference products in accordance with the experience and principles introduced in the European countries.

Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the management of schizophrenia and related disorders.

PubMed

Galletly, Cherrie; Castle, David; Dark, Frances; Humberstone, Verity; Jablensky, Assen; Killackey, Eóin; Kulkarni, Jayashri; McGorry, Patrick; Nielssen, Olav; Tran, Nga

2016-05-01

This guideline provides recommendations for the clinical management of schizophrenia and related disorders for health professionals working in Australia and New Zealand. It aims to encourage all clinicians to adopt best practice principles. The recommendations represent the consensus of a group of Australian and New Zealand experts in the management of schizophrenia and related disorders. This guideline includes the management of ultra-high risk syndromes, first-episode psychoses and prolonged psychoses, including psychoses associated with substance use. It takes a holistic approach, addressing all aspects of the care of people with schizophrenia and related disorders, not only correct diagnosis and symptom relief but also optimal recovery of social function. The writing group planned the scope and individual members drafted sections according to their area of interest and expertise, with reference to existing systematic reviews and informal literature reviews undertaken for this guideline. In addition, experts in specific areas contributed to the relevant sections. All members of the writing group reviewed the entire document. The writing group also considered relevant international clinical practice guidelines. Evidence-based recommendations were formulated when the writing group judged that there was sufficient evidence on a topic. Where evidence was weak or lacking, consensus-based recommendations were formulated. Consensus-based recommendations are based on the consensus of a group of experts in the field and are informed by their agreement as a group, according to their collective clinical and research knowledge and experience. Key considerations were selected and reviewed by the writing group. To encourage wide community participation, the Royal Australian and New Zealand College of Psychiatrists invited review by its committees and members, an expert advisory committee and key stakeholders including professional bodies and special interest groups. The clinical practice guideline for the management of schizophrenia and related disorders reflects an increasing emphasis on early intervention, physical health, psychosocial treatments, cultural considerations and improving vocational outcomes. The guideline uses a clinical staging model as a framework for recommendations regarding assessment, treatment and ongoing care. This guideline also refers its readers to selected published guidelines or statements directly relevant to Australian and New Zealand practice. This clinical practice guideline for the management of schizophrenia and related disorders aims to improve care for people with these disorders living in Australia and New Zealand. It advocates a respectful, collaborative approach; optimal evidence-based treatment; and consideration of the specific needs of those in adverse circumstances or facing additional challenges. © The Royal Australian and New Zealand College of Psychiatrists 2016.

Mobile phone interference with medical equipment and its clinical relevance: a systematic review.

PubMed

Lawrentschuk, Nathan; Bolton, Damien M

2004-08-02

To conduct a systematic review of studies on clinically relevant digital mobile phone electromagnetic interference with medical equipment. MEDLINE and SUMSEARCH were searched for the period 1966-2004. The Cochrane Library and Database of Abstracts of Reviews of Effects were also searched for systematic reviews. Studies were eligible if published in a peer-reviewed journal in English, and if they included testing of digital mobile phones for clinically relevant interference with medical equipment used to monitor or treat patients, but not implantable medical devices. As there was considerable heterogeneity in medical equipment studied and the conduct of testing, results were summarised rather than subjected to meta-analysis. Clinically relevant electromagnetic interference (EMI) secondary to mobile phones potentially endangering patients occurred in 45 of 479 devices tested at 900 MHz and 14 of 457 devices tested at 1800 MHz. However, in the largest studies, the prevalence of clinically relevant EMI was low. Most clinically relevant EMI occurred when mobile phones were used within 1 m of medical equipment. Although testing was not standardised between studies and equipment tested was not identical, it is of concern that at least 4% of devices tested in any study were susceptible to clinically relevant EMI. All studies recommend some type of restriction of mobile phone use in hospitals, with use greater than 1 m from equipment and restrictions in clinical areas being the most common.

Standard requirements for GCP-compliant data management in multinational clinical trials.

PubMed

Ohmann, Christian; Kuchinke, Wolfgang; Canham, Steve; Lauritsen, Jens; Salas, Nader; Schade-Brittinger, Carmen; Wittenberg, Michael; McPherson, Gladys; McCourt, John; Gueyffier, Francois; Lorimer, Andrea; Torres, Ferràn

2011-03-22

A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit. Section IN01 is dedicated to international aspects and ST01 to the competence of a trials unit's staff. The standard is intended to provide an open and widely used set of requirements for GCP-compliant data management, particularly in academic trial units. It is the intention that ECRIN will use these requirements as the basis for the certification of ECRIN data centres.

Hepatitis C and autoreactivity.

PubMed

Bianchi, Francesco B; Muratori, Paolo; Granito, Alessandro; Pappas, Georgios; Ferri, Silvia; Muratori, Luigi

2007-09-01

After the discovery of HCV in 1989 a great amount of data has been produced in order to identify a possible aetiology for a number of idiopathic diseases, especially those with a suspected immune origin. Many associations have not been confirmed by prospective studies (as in the case of autoimmune hepatitis); other immune abnormalities, such as the emergence of non organ-specific autoantibodies and cryoglobulins, have been reported by many specific studies. To date, the link between HCV and autoreactivity is tentatively explained on the basis of sequence homologies shared by the HCV polyprotein and "self" proteins (such as CYP 2D6, target of anti-LKM1) (molecular mimicry mechanism); a second interpretation relies on the demonstration that the HCV - B lymphocyte interaction is able to induce a polyclonal B cell activation, an important cofactor for the development of clinically relevant B-lymphocyte autoimmune disorders. In this review we will focus on the major aspects of the autoimmune phenomena in HCV-infected patients, their clinical and therapeutical implications.

Phlebotomy, a bridge between laboratory and patient.

PubMed

Ialongo, Cristiano; Bernardini, Sergio

2016-01-01

The evidence-based paradigm has changed and evolved medical practice. Phlebotomy, which dates back to the age of ancient Greece, has gained experience through the evolution of medicine becoming a fundamental diagnostic tool. Nowadays it connects the patient with the clinical laboratory dimension building up a bridge. However, more often there is a gap between laboratory and phlebotomist that causes misunderstandings and burdens on patient safety. Therefore, the scope of this review is delivering a view of modern phlebotomy to "bridge" patient and laboratory. In this regard the paper describes devices, tools and procedures in the light of the most recent scientific findings, also discussing their impact on both quality of blood testing and patient safety. It also addresses the issues concerning medical aspect of venipuncture, like the practical approach to the superficial veins anatomy, as well as the management of the patient's compliance with the blood draw. Thereby, the clinical, technical and practical issues are treated with the same relevance throughout the entire paper.

Recent Advances and Future of Gene Therapy for Bone Regeneration.

PubMed

Shapiro, Galina; Lieber, Raphael; Gazit, Dan; Pelled, Gadi

2018-06-16

The purpose of this review is to discuss the recent advances in gene therapy as a treatment for bone regeneration. While most fractures heal spontaneously, patients who present with fracture nonunion suffer from prolonged pain, disability, and often require additional operations to regain musculoskeletal function. In the last few years, BMP gene delivery by means of electroporation and sonoporation resulted in repair of nonunion bone defects in mice, rats, and minipigs. Ex vivo transfection of porcine mesenchymal stem cells (MSCs) resulted in bone regeneration following implantation in vertebral defects of minipigs. Sustained release of VEGF gene from a collagen-hydroxyapatite scaffold to the mandible of a human patient was shown to be safe and osteoinductive. In conclusion, gene therapy methods for bone regeneration are systematically becoming more efficient and show proof-of-concept in clinically relevant animal models. Yet, on the pathway to clinical use, more investigation is needed to determine the safety aspects of the various techniques in terms of biodistribution, toxicity, and tumorigenicity.

Nanoscale effects in dendrimer-mediated targeting of neuroinflammation

PubMed Central

Nance, Elizabeth; Zhang, Fan; Mishra, Manoj K.; Zhang, Zhi; Kambhampati, Siva P.; Kannan, Rangaramanujam M.; Kannan, Sujatha

2017-01-01

Neuroinflammation, mediated by activated microglia and astrocytes, plays a key role in the pathogenesis of many neurological disorders. Systemically-administered dendrimers target neuroinflammation and deliver drugs with significant efficacy, without the need for ligands. Elucidating the nanoscale aspects of targeting neuroinflammation will enable superior nanodevices for eventual translation. Using a rabbit model of cerebral palsy, we studied the in vivo contributions of dendrimer physicochemical properties and disease pathophysiology on dendrimer brain uptake, diffusion, and cell specific localization. Neutral dendrimers move efficiently within the brain parenchyma and rapidly localize in glial cells in regions of injury. Dendrimer uptake is also dependent on the extent of blood-brain-barrier breakdown, glial activation, and disease severity (mild, moderate, or severe), which can lend the dendrimer to be used as an imaging biomarker for disease phenotype. This new understanding of the in vivo mechanism of dendrimer-mediated delivery in a clinically-relevant rabbit model provides greater opportunity for clinical translation of targeted brain injury therapies. PMID:27267631

Phlebotomy, a bridge between laboratory and patient

PubMed Central

Ialongo, Cristiano; Bernardini, Sergio

2016-01-01

The evidence-based paradigm has changed and evolved medical practice. Phlebotomy, which dates back to the age of ancient Greece, has gained experience through the evolution of medicine becoming a fundamental diagnostic tool. Nowadays it connects the patient with the clinical laboratory dimension building up a bridge. However, more often there is a gap between laboratory and phlebotomist that causes misunderstandings and burdens on patient safety. Therefore, the scope of this review is delivering a view of modern phlebotomy to “bridge” patient and laboratory. In this regard the paper describes devices, tools and procedures in the light of the most recent scientific findings, also discussing their impact on both quality of blood testing and patient safety. It also addresses the issues concerning medical aspect of venipuncture, like the practical approach to the superficial veins anatomy, as well as the management of the patient’s compliance with the blood draw. Thereby, the clinical, technical and practical issues are treated with the same relevance throughout the entire paper. PMID:26981016

Nanoscale effects in dendrimer-mediated targeting of neuroinflammation.

PubMed

Nance, Elizabeth; Zhang, Fan; Mishra, Manoj K; Zhang, Zhi; Kambhampati, Siva P; Kannan, Rangaramanujam M; Kannan, Sujatha

2016-09-01

Neuroinflammation, mediated by activated microglia and astrocytes, plays a key role in the pathogenesis of many neurological disorders. Systemically-administered dendrimers target neuroinflammation and deliver drugs with significant efficacy, without the need for ligands. Elucidating the nanoscale aspects of targeting neuroinflammation will enable superior nanodevices for eventual translation. Using a rabbit model of cerebral palsy, we studied the in vivo contributions of dendrimer physicochemical properties and disease pathophysiology on dendrimer brain uptake, diffusion, and cell specific localization. Neutral dendrimers move efficiently within the brain parenchyma and rapidly localize in glial cells in regions of injury. Dendrimer uptake is also dependent on the extent of blood-brain-barrier breakdown, glial activation, and disease severity (mild, moderate, or severe), which can lend the dendrimer to be used as an imaging biomarker for disease phenotype. This new understanding of the in vivo mechanism of dendrimer-mediated delivery in a clinically-relevant rabbit model provides greater opportunity for clinical translation of targeted brain injury therapies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Relevance of health economics in breast cancer treatment: integration of economics in the management of breast cancer at the clinic level.

PubMed

Jacobs, Volker R; Bogner, Gerhard; Schausberger, Christiane E; Reitsamer, Roland; Fischer, Thorsten

2013-03-01

Since the introduction of the diagnosis-related groups (DRG) system with cost-related and entity-specific flat-rate reimbursements for all in-patients in 2004 in Germany, economics have become an important focus in medical care, including breast centers. Since then, physicians and hospitals have had to gradually take on more and more financial responsibilities for their medical care to avoid losses for their institutions. Due to financial limitations of resources, most medical services have to be adjusted to correlating revenues, which results in the development of a variety of active measures to understand, steer, and optimize costs, resources and related processes for breast cancer treatment. In this review, the challenging task to implement microeconomic management at the clinic level for breast cancer treatment is analyzed from breast cancer-specific publications. The newly developed economic management perspective is identified for different stakeholders in the healthcare system, and successful microeconomic projects and future aspects are described.

Hypersomnia and depressive symptoms: methodological and clinical aspects

PubMed Central

2013-01-01

The associations between depressive symptoms and hypersomnia are complex and often bidirectional. Of the many disorders associated with excessive sleepiness in the general population, the most frequent are mental health disorders, particularly depression. However, most mood disorder studies addressing hypersomnia have assessed daytime sleepiness using a single response, neglecting critical and clinically relevant information about symptom severity, duration and nighttime sleep quality. Only a few studies have used objective tools such as polysomnography to directly measure both daytime and nighttime sleep propensity in depression with normal mean sleep latency and sleep duration. Hypersomnia in mood disorders, rather than a medical condition per se, is more a subjective sleep complaint than an objective finding. Mood symptoms have also been frequently reported in hypersomnia disorders of central origin, especially in narcolepsy. Hypocretin deficiency could be a contributing factor in this condition. Further interventional studies are needed to explore whether management of sleep complaints improves mood symptoms in hypersomnia disorders and, conversely, whether management of mood complaints improves sleep symptoms in mood disorders. PMID:23514569

Perceptually-oriented hypnosis: removing a socially learned pathology and developing adequacy: the case of invisible girl.

PubMed

Woodard, Fredrick James

2014-10-01

This is the first case review to explicate perceptual hypnotic principles such as differentiation, characteristics of an adequate personality, and the need for adequacy, as utilized in clinical hypnosis in a complex case that altered the distorted perceptions and personal meanings of an eleven-year-old girl who believed that she had Bipolar Disorder and her body and mind were damaged. This qualitative case study examines aspects of hypnosis during therapy from a perceptual point of view to illustrate frustrations in difficult cases and identify some of the causes and origins of alleged clinical pathology in adverse environments. Some moments of effective self-healing through supporting internally controlled changes in perception during hypnotic experiencing are highlighted rather than externally focusing on observed thoughts and behavior. Factors relevant to social psychological research, such as family dynamics, poverty, and interactions with social service agencies and institutions, creating learned pathology, are pointed out for future research.

Relevance of Health Economics in Breast Cancer Treatment: Integration of Economics in the Management of Breast Cancer at the Clinic Level

PubMed Central

Jacobs, Volker R.; Bogner, Gerhard; Schausberger, Christiane E.; Reitsamer, Roland; Fischer, Thorsten

2013-01-01

Summary Since the introduction of the diagnosis-related groups (DRG) system with cost-related and entity-specific flat-rate reimbursements for all in-patients in 2004 in Germany, economics have become an important focus in medical care, including breast centers. Since then, physicians and hospitals have had to gradually take on more and more financial responsibilities for their medical care to avoid losses for their institutions. Due to financial limitations of resources, most medical services have to be adjusted to correlating revenues, which results in the development of a variety of active measures to understand, steer, and optimize costs, resources and related processes for breast cancer treatment. In this review, the challenging task to implement microeconomic management at the clinic level for breast cancer treatment is analyzed from breast cancer-specific publications. The newly developed economic management perspective is identified for different stakeholders in the healthcare system, and successful microeconomic projects and future aspects are described. PMID:24715837

Assessment in health psychology: Introduction to the special issue.

PubMed

Butt, Zeeshan

2016-09-01

For the past 27 years, Psychological Assessment has been committed to publishing empirical research relevant to clinical assessment of basic and applied cognition, personality, interpersonal behavior, psychopathology, forensics, and biological psychology. There is growing interest in the use of patient-centered outcomes in medical/surgical care and for measuring health care performance. Patient-centered outcome measures complement traditional clinical outcomes of morbidity and mortality, capturing the patient’s perspective regarding their health and its treatment. In this issue, we highlight 11 articles that address different aspects of such work. The articles in this special issue represent both the depth and breadth of the opportunities that exist for psychological assessment in the health setting. While there are countless patient-centered measures currently in use to measure health and health outcomes, the evidence base for their use can be quite variable (Butt, 2016). The hope is that future issues of Psychological Assessment will highlight more work in this area. PsycINFO Database Record (c) 2016 APA, all rights reserved

Utility of HLA Antibody Testing in Kidney Transplantation

PubMed Central

Konvalinka, Ana

2015-01-01

HLA antigens are polymorphic proteins expressed on donor kidney allograft endothelium and are critical targets for recipient immune recognition. HLA antibodies are risk factors for acute and chronic rejection and allograft loss. Solid-phase immunoassays for HLA antibody detection represent a major advance in sensitivity and specificity over cell-based methods and are widely used in organ allocation and pretransplant risk assessment. Post-transplant, development of de novo donor–specific HLA antibodies and/or increase in donor-specific antibodies from pretransplant levels are associated with adverse outcomes. Although single antigen bead assays have allowed sensitive detection of recipient HLA antibodies and their specificities, a number of interpretive considerations must be appreciated to understand test results in clinical and research contexts. This review, which is especially relevant for clinicians caring for transplant patients, discusses the technical aspects of single antigen bead assays, emphasizes their quantitative limitations, and explores the utility of HLA antibody testing in identifying and managing important pre- and post-transplant clinical outcomes. PMID:25804279

Technical Aspects of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: CHEST Guideline and Expert Panel Report.

PubMed

Wahidi, Momen M; Herth, Felix; Yasufuku, Kazuhiro; Shepherd, Ray Wesley; Yarmus, Lonny; Chawla, Mohit; Lamb, Carla; Casey, Kenneth R; Patel, Sheena; Silvestri, Gerard A; Feller-Kopman, David J

2016-03-01

Endobronchial ultrasound (EBUS) was introduced in the last decade, enabling real-time guidance of transbronchial needle aspiration (TBNA) of mediastinal and hilar structures and parabronchial lung masses. The many publications produced about EBUS-TBNA have led to a better understanding of the performance characteristics of this procedure. The goal of this document was to examine the current literature on the technical aspects of EBUS-TBNA as they relate to patient, technology, and proceduralist factors to provide evidence-based and expert guidance to clinicians. Rigorous methodology has been applied to provide a trustworthy evidence-based guideline and expert panel report. A group of approved panelists developed key clinical questions by using the PICO (population, intervention, comparator, and outcome) format that addressed specific topics on the technical aspects of EBUS-TBNA. MEDLINE (via PubMed) and the Cochrane Library were systematically searched for relevant literature, which was supplemented by manual searches. References were screened for inclusion, and well-recognized document evaluation tools were used to assess the quality of included studies, to extract meaningful data, and to grade the level of evidence to support each recommendation or suggestion. Our systematic review and critical analysis of the literature on 15 PICO questions related to the technical aspects of EBUS-TBNA resulted in 12 statements: 7 evidence-based graded recommendations and 5 ungraded consensus-based statements. Three questions did not have sufficient evidence to generate a statement. Evidence on the technical aspects of EBUS-TBNA varies in strength but is satisfactory in certain areas to guide clinicians on the best conditions to perform EBUS-guided tissue sampling. Additional research is needed to enhance our knowledge regarding the optimal performance of this effective procedure. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Evaluation of linear classifiers on articles containing pharmacokinetic evidence of drug-drug interactions.

PubMed

Kolchinsky, A; Lourenço, A; Li, L; Rocha, L M

2013-01-01

Drug-drug interaction (DDI) is a major cause of morbidity and mortality. DDI research includes the study of different aspects of drug interactions, from in vitro pharmacology, which deals with drug interaction mechanisms, to pharmaco-epidemiology, which investigates the effects of DDI on drug efficacy and adverse drug reactions. Biomedical literature mining can aid both kinds of approaches by extracting relevant DDI signals from either the published literature or large clinical databases. However, though drug interaction is an ideal area for translational research, the inclusion of literature mining methodologies in DDI workflows is still very preliminary. One area that can benefit from literature mining is the automatic identification of a large number of potential DDIs, whose pharmacological mechanisms and clinical significance can then be studied via in vitro pharmacology and in populo pharmaco-epidemiology. We implemented a set of classifiers for identifying published articles relevant to experimental pharmacokinetic DDI evidence. These documents are important for identifying causal mechanisms behind putative drug-drug interactions, an important step in the extraction of large numbers of potential DDIs. We evaluate performance of several linear classifiers on PubMed abstracts, under different feature transformation and dimensionality reduction methods. In addition, we investigate the performance benefits of including various publicly-available named entity recognition features, as well as a set of internally-developed pharmacokinetic dictionaries. We found that several classifiers performed well in distinguishing relevant and irrelevant abstracts. We found that the combination of unigram and bigram textual features gave better performance than unigram features alone, and also that normalization transforms that adjusted for feature frequency and document length improved classification. For some classifiers, such as linear discriminant analysis (LDA), proper dimensionality reduction had a large impact on performance. Finally, the inclusion of NER features and dictionaries was found not to help classification.

Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

Neuroimaging and Neuromodulation: Complementary Approaches for Identifying the Neuronal Correlates of Tinnitus

PubMed Central

Langguth, Berthold; Schecklmann, Martin; Lehner, Astrid; Landgrebe, Michael; Poeppl, Timm Benjamin; Kreuzer, Peter Michal; Schlee, Winfried; Weisz, Nathan; Vanneste, Sven; De Ridder, Dirk

2012-01-01

An inherent limitation of functional imaging studies is their correlational approach. More information about critical contributions of specific brain regions can be gained by focal transient perturbation of neural activity in specific regions with non-invasive focal brain stimulation methods. Functional imaging studies have revealed that tinnitus is related to alterations in neuronal activity of central auditory pathways. Modulation of neuronal activity in auditory cortical areas by repetitive transcranial magnetic stimulation (rTMS) can reduce tinnitus loudness and, if applied repeatedly, exerts therapeutic effects, confirming the relevance of auditory cortex activation for tinnitus generation and persistence. Measurements of oscillatory brain activity before and after rTMS demonstrate that the same stimulation protocol has different effects on brain activity in different patients, presumably related to interindividual differences in baseline activity in the clinically heterogeneous study cohort. In addition to alterations in auditory pathways, imaging techniques also indicate the involvement of non-auditory brain areas, such as the fronto-parietal “awareness” network and the non-tinnitus-specific distress network consisting of the anterior cingulate cortex, anterior insula, and amygdale. Involvement of the hippocampus and the parahippocampal region putatively reflects the relevance of memory mechanisms in the persistence of the phantom percept and the associated distress. Preliminary studies targeting the dorsolateral prefrontal cortex, the dorsal anterior cingulate cortex, and the parietal cortex with rTMS and with transcranial direct current stimulation confirm the relevance of the mentioned non-auditory networks. Available data indicate the important value added by brain stimulation as a complementary approach to neuroimaging for identifying the neuronal correlates of the various clinical aspects of tinnitus. PMID:22509155

Nurses' decision-making in ethically relevant clinical situations using the example of breathlessness: study protocol of a reflexive grounded theory integrating Goffman's framework analysis.

PubMed

Dunger, Christine; Schnell, Martin W; Bausewein, Claudia

2017-02-22

Decision-making (DM) in healthcare can be understood as an interactive process addressing decision makers' reasoning as well as their visible behaviour after the decision is made. Other key elements of DM are ethical aspects and the role as well as the treatment options of the examined professions. Nurses' DM to choose interventions in situations of severe breathlessness is such interactions. They are also ethically relevant regarding the vulnerability of affected patients and possible restrictions or treatment options. The study aims to explore which factors influence nurses' DM to use nursing interventions in situations where patients suffer from severe breathlessness. Qualitative study including nurses in German hospital wards and hospices. A triangulation of different methods of data collection-participant observation and qualitative expert interviews-and analysis merge in a reflexive grounded theory approach which integrates Goffman's framework analysis. It allows an analysis of nurses' self-statements about DM, their behaviour in relevant clinical situations and its influences. Data collection and analysis will be examined simultaneously. Informed consent will be gained from all participants and the institutional stakeholders. Ongoing consent has to be ensured since observations will take place in healthcare institutions and many patients will be highly vulnerable. The study has been evaluated and approved by the Witten/Herdecke University Ethics Committee, Witten, Germany. Results of the study will be published at congresses and in journal papers. 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/.

Aspects of the Cognitive Model of Physics Problem Solving.

ERIC Educational Resources Information Center

Brekke, Stewart E.

Various aspects of the cognitive model of physics problem solving are discussed in detail including relevant cues, encoding, memory, and input stimuli. The learning process involved in the recognition of familiar and non-familiar sensory stimuli is highlighted. Its four components include selection, acquisition, construction, and integration. The…

Designing Culturally Responsive and Relevant Individualized Educational Programs

ERIC Educational Resources Information Center

Barrio, Brenda L.; Miller, Darcy; Hsiao, Yun-Ju; Dunn, Michael; Petersen, Sara; Hollingshead, Aleksandra; Banks, Susan

2017-01-01

Developing culturally responsive and relevant individualized educational programs (IEP) is becoming increasingly more important as the student population becomes more diverse. Current supports available for IEP teams primarily address the technical aspects of the IEP (e.g., writing goals that are measurable) but offer little assistance in…

How to Assess Gaming-Induced Benefits on Attention and Working Memory.

PubMed

Mishra, Jyoti; Bavelier, Daphne; Gazzaley, Adam

2012-06-01

Our daily actions are driven by our goals in the moment, constantly forcing us to choose among various options. Attention and working memory are key enablers of that process. Attention allows for selective processing of goal-relevant information and rejecting task-irrelevant information. Working memory functions to maintain goal-relevant information in memory for brief periods of time for subsequent recall and/or manipulation. Efficient attention and working memory thus support the best extraction and retention of environmental information for optimal task performance. Recent studies have evidenced that attention and working memory abilities can be enhanced by cognitive training games as well as entertainment videogames. Here we review key cognitive paradigms that have been used to evaluate the impact of game-based training on various aspects of attention and working memory. Common use of such methodology within the scientific community will enable direct comparison of the efficacy of different games across age groups and clinical populations. The availability of common assessment tools will ultimately facilitate development of the most effective forms of game-based training for cognitive rehabilitation and education.

How to Assess Gaming-Induced Benefits on Attention and Working Memory

PubMed Central

Mishra, Jyoti; Bavelier, Daphne

2012-01-01

Abstract Our daily actions are driven by our goals in the moment, constantly forcing us to choose among various options. Attention and working memory are key enablers of that process. Attention allows for selective processing of goal-relevant information and rejecting task-irrelevant information. Working memory functions to maintain goal-relevant information in memory for brief periods of time for subsequent recall and/or manipulation. Efficient attention and working memory thus support the best extraction and retention of environmental information for optimal task performance. Recent studies have evidenced that attention and working memory abilities can be enhanced by cognitive training games as well as entertainment videogames. Here we review key cognitive paradigms that have been used to evaluate the impact of game-based training on various aspects of attention and working memory. Common use of such methodology within the scientific community will enable direct comparison of the efficacy of different games across age groups and clinical populations. The availability of common assessment tools will ultimately facilitate development of the most effective forms of game-based training for cognitive rehabilitation and education. PMID:24761314

What does the amygdala contribute to social cognition?

PubMed Central

Adolphs, Ralph

2010-01-01

The amygdala has received intense recent attention from neuroscientists investigating its function at the molecular, cellular, systems, cognitive, and clinical level. It clearly contributes to processing emotionally and socially relevant information, yet a unifying description and computational account have been lacking. The difficulty of tying together the various studies stems in part from the sheer diversity of approaches and species studied, in part from the amygdala’s inherent heterogeneity in terms of its component nuclei, and in part because different investigators have simply been interested in different topics. Yet, a synthesis now seems close at hand in combining new results from social neuroscience with data from neuroeconomics and reward learning. The amygdala processes a psychological stimulus dimension related to saliency or relevance; mechanisms have been identified to link it to processing unpredictability; and insights from reward learning have situated it within a network of structures that include the prefrontal cortex and the ventral striatum in processing the current value of stimuli. These aspects help to clarify the amygdala’s contributions to recognizing emotion from faces, to social behavior toward conspecifics, and to reward learning and instrumental behavior. PMID:20392275

Redox-Assisted Protein Folding Systems in Eukaryotic Parasites

PubMed Central

Haque, Saikh Jaharul; Majumdar, Tanmay

2012-01-01

Abstract Significance: The cysteine (Cys) residues of proteins play two fundamentally important roles. They serve as sites of post-translational redox modifications as well as influence the conformation of the protein through the formation of disulfide bonds. Recent Advances: Redox-related and redox-associated protein folding in protozoan parasites has been found to be a major mode of regulation, affecting myriad aspects of the parasitic life cycle, host-parasite interactions, and the disease pathology. Available genome sequences of various parasites have begun to complement the classical biochemical and enzymological studies of these processes. In this article, we summarize the reversible Cys disulfide (S-S) bond formation in various classes of strategically important parasitic proteins, and its structural consequence and functional relevance. Critical Issues: Molecular mechanisms of folding remain under-studied and often disconnected from functional relevance. Future Directions: The clinical benefit of redox research will require a comprehensive characterization of the various isoforms and paralogs of the redox enzymes and their concerted effect on the structure and function of the specific parasitic client proteins. Antioxid. Redox Signal. 17, 674–683. PMID:22122448

Antibiotic resistance and molecular characterization of probiotic and clinical Lactobacillus strains in relation to safety aspects of probiotics.

PubMed

Klein, Günter

2011-02-01

The evaluation of the safety of probiotic strains includes the exclusion of antibiotic resistance of clinical importance. Ninety-two strains from the genus Lactobacillus isolated from probiotics, food, and clinical sources were included in the investigation. Species tested were the L. acidophilus group, L. casei group, L. reuteri/fermentum group, and L. sakei/curvatus group. Cell and colony morphology, fermentation patterns, and growth characteristics as well as soluble whole cell proteins were analyzed. Antibiotic resistance against clinically important agents was determined by broth dilution tests. The vanA and tet genes were confirmed. Resistances occurred mainly against gentamicin, ciprofloxacin, clindamycin, sulfonamides, and, in some cases, glycopeptides. The natural glycopeptide resistance within the L. casei group and L. reuteri appears to be not of clinical relevance, as there was no vanA gene present. Therefore, the transfer of this resistance is very unlikely. Tet-(A), -(B), -(C), -(M), or -(O) gene could not be detected. The protein fingerprinting within the L. casei group proved that L. rhamnosus strains of clinical origin clustered together with probiotic strains. For safety evaluations resistance patterns of a broad range of strains are a useful criterion together with the exclusion of known resistance genes (like the vanA gene) and can be used for decision making on the safety of probiotics, both by authorization bodies and manufacturers.

The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials.

PubMed

Clayton, Gemma L; Smith, Isabelle L; Higgins, Julian P T; Mihaylova, Borislava; Thorpe, Benjamin; Cicero, Robert; Lokuge, Kusal; Forman, Julia R; Tierney, Jayne F; White, Ian R; Sharples, Linda D; Jones, Hayley E

2017-05-15

When designing and analysing clinical trials, using previous relevant information, perhaps in the form of evidence syntheses, can reduce research waste. We conducted the INVEST (INVestigating the use of Evidence Synthesis in the design and analysis of clinical Trials) survey to summarise the current use of evidence synthesis in trial design and analysis, to capture opinions of trialists and methodologists on such use, and to understand any barriers. Our sampling frame was all delegates attending the International Clinical Trials Methodology Conference in November 2015. Respondents were asked to indicate (1) their views on the use of evidence synthesis in trial design and analysis, (2) their own use during the past 10 years and (3) the three greatest barriers to use in practice. Of approximately 638 attendees of the conference, 106 (17%) completed the survey, half of whom were statisticians. Support was generally high for using a description of previous evidence, a systematic review or a meta-analysis in trial design. Generally, respondents did not seem to be using evidence syntheses as often as they felt they should. For example, only 50% (42/84 relevant respondents) had used a meta-analysis to inform whether a trial is needed compared with 74% (62/84) indicating that this is desirable. Only 6% (5/81 relevant respondents) had used a value of information analysis to inform sample size calculations versus 22% (18/81) indicating support for this. Surprisingly large numbers of participants indicated support for, and previous use of, evidence syntheses in trial analysis. For example, 79% (79/100) of respondents indicated that external information about the treatment effect should be used to inform aspects of the analysis. The greatest perceived barrier to using evidence synthesis methods in trial design or analysis was time constraints, followed by a belief that the new trial was the first in the area. Evidence syntheses can be resource-intensive, but their use in informing the design, conduct and analysis of clinical trials is widely considered desirable. We advocate additional research, training and investment in resources dedicated to ways in which evidence syntheses can be undertaken more efficiently, offering the potential for cost savings in the long term.

Fine-grained information extraction from German transthoracic echocardiography reports.

PubMed

Toepfer, Martin; Corovic, Hamo; Fette, Georg; Klügl, Peter; Störk, Stefan; Puppe, Frank

2015-11-12

Information extraction techniques that get structured representations out of unstructured data make a large amount of clinically relevant information about patients accessible for semantic applications. These methods typically rely on standardized terminologies that guide this process. Many languages and clinical domains, however, lack appropriate resources and tools, as well as evaluations of their applications, especially if detailed conceptualizations of the domain are required. For instance, German transthoracic echocardiography reports have not been targeted sufficiently before, despite of their importance for clinical trials. This work therefore aimed at development and evaluation of an information extraction component with a fine-grained terminology that enables to recognize almost all relevant information stated in German transthoracic echocardiography reports at the University Hospital of Würzburg. A domain expert validated and iteratively refined an automatically inferred base terminology. The terminology was used by an ontology-driven information extraction system that outputs attribute value pairs. The final component has been mapped to the central elements of a standardized terminology, and it has been evaluated according to documents with different layouts. The final system achieved state-of-the-art precision (micro average.996) and recall (micro average.961) on 100 test documents that represent more than 90 % of all reports. In particular, principal aspects as defined in a standardized external terminology were recognized with f 1=.989 (micro average) and f 1=.963 (macro average). As a result of keyword matching and restraint concept extraction, the system obtained high precision also on unstructured or exceptionally short documents, and documents with uncommon layout. The developed terminology and the proposed information extraction system allow to extract fine-grained information from German semi-structured transthoracic echocardiography reports with very high precision and high recall on the majority of documents at the University Hospital of Würzburg. Extracted results populate a clinical data warehouse which supports clinical research.

Assessment of the awareness and management of cardiovascular complications of acromegaly in Italy. The COM.E.T.A. (COMorbidities Evaluation and Treatment in Acromegaly) Study.

PubMed

Giustina, A; Mancini, T; Boscani, P F; de Menis, E; degli Uberti, E; Ghigo, E; Martino, E; Minuto, F; Colao, A

2008-08-01

During the course of acromegaly, cardiovascular, respiratory, and metabolic co-morbidities contribute to enhanced mortality. In 2002, the Pituitary Society and the European Neuroendocrine Association sponsored a Consensus Workshop in Versailles during which guidelines for diagnosis and treatment of co-morbidities in acromegaly were defined. However, as for other guidelines previously issued in the field, no data are available on their clinical application. The aim of this work coordinated by the Italian Study group on co-morbidities evaluation and treatment in acromegaly (COM.E.T.A.) was to assess, on a national basis, the application in the clinical practice of the Versailles criteria for diagnosis and treatment of cardiovascular comorbities in acromegaly. In January 2007 an ad hoc designed questionnaire was sent by mail to 130 endocrine Centers in Italy. The guidelines have been generally well perceived and translated in clinical practice. Specifically: 1) echocardiography is considered the mainstay for the diagnosis and follow-up; 2) ambulatory blood pressure monitoring and blood lipid assessment are performed in most hypertensive patients; 3) most endocrinologists directly manage hypertension and are aware of the uncertainty of the effect of the control of the disease on blood pressure levels; 4) ACE inhibitors and angiotensin receptors blockers are first-choice anti-hypertensive treatment; 5) approximately half of the centers consider somatostatin analogues of paramount relevance for biochemical control of disease; 6) awareness that left ventricular hypertrophy and heart failure are the most relevant cardiovascular complications is high although the impact of ischemic, arrhythmic, and valvular complications on prognosis is less well perceived. The results of the present survey suggest that previuosly issued guidelines are generally carefully followed in the clinical practice. On the other side, a certain lack of awareness of emerging aspects of the cardiovascular comorbities of acromegaly confirms the necessity of periodically updating the guidelines based on the availability of new clinical information.

Clinical leadership development in a pre-registration nursing curriculum: What the profession has to say about it.

PubMed

Brown, Angela; Crookes, Patrick; Dewing, Jan

2016-01-01

In the last decade literature, inquiries and reports into the short comings in health services have highlighted the vital role of leadership in clinical practice and the impact on patient care and effective workplace culture. Whilst there is an abundance of literature on leadership and the registered nursing workforce, an international literature review revealed there is very little known on leadership development in pre-registration nursing programmes. To identify what the profession's views are on proposed indicative curriculum content suggested for clinical leadership development in a pre-registration nursing degree in Australia. This is a multi-method research study. This paper presents the development and results of one aspect of the study, a national online survey. Nurses: clinicians, managers and academics. In the absence of a strong evidence base in the literature review, additional pre-requisite curriculum content was augmented from the work of two published frameworks of leadership and management. From this a 67-item survey was designed to ask the profession whether the aggregated content is a reasonable view of what should be included in a pre-registration programme to develop clinical leadership. The survey sought the views of nurses on whether the proposed content was relevant (yes/no) and their opinion on whether it is significant via a 5-point Likert scale. Descriptive and chi-square analyses were performed in SPSS v.19. A total of 418 nurses completed the survey; there was consensus amongst the profession on what is considered relevant and important in a pre-registration nursing programme. The content identified could be considered indicative and pre-requisite to include in a pre-registration nursing programme. Members of the nursing profession in Australia have clear views about this. The next step is to design and evaluate a purposeful pedagogical approach and curriculum, leading to the development of clinical leadership knowledge, skills and behaviours in newly graduating nurses. Copyright © 2015 Elsevier Ltd. All rights reserved.

Representation of Time-Relevant Common Data Elements in the Cancer Data Standards Repository: Statistical Evaluation of an Ontological Approach

PubMed Central

Chen, Henry W; Du, Jingcheng; Song, Hsing-Yi; Liu, Xiangyu; Jiang, Guoqian

2018-01-01

Background Today, there is an increasing need to centralize and standardize electronic health data within clinical research as the volume of data continues to balloon. Domain-specific common data elements (CDEs) are emerging as a standard approach to clinical research data capturing and reporting. Recent efforts to standardize clinical study CDEs have been of great benefit in facilitating data integration and data sharing. The importance of the temporal dimension of clinical research studies has been well recognized; however, very few studies have focused on the formal representation of temporal constraints and temporal relationships within clinical research data in the biomedical research community. In particular, temporal information can be extremely powerful to enable high-quality cancer research. Objective The objective of the study was to develop and evaluate an ontological approach to represent the temporal aspects of cancer study CDEs. Methods We used CDEs recorded in the National Cancer Institute (NCI) Cancer Data Standards Repository (caDSR) and created a CDE parser to extract time-relevant CDEs from the caDSR. Using the Web Ontology Language (OWL)–based Time Event Ontology (TEO), we manually derived representative patterns to semantically model the temporal components of the CDEs using an observing set of randomly selected time-related CDEs (n=600) to create a set of TEO ontological representation patterns. In evaluating TEO’s ability to represent the temporal components of the CDEs, this set of representation patterns was tested against two test sets of randomly selected time-related CDEs (n=425). Results It was found that 94.2% (801/850) of the CDEs in the test sets could be represented by the TEO representation patterns. Conclusions In conclusion, TEO is a good ontological model for representing the temporal components of the CDEs recorded in caDSR. Our representative model can harness the Semantic Web reasoning and inferencing functionalities and present a means for temporal CDEs to be machine-readable, streamlining meaningful searches. PMID:29472179

Tools in the assessment of sarcopenia

PubMed Central

Cooper, C; Fielding, R; Visser, M; van Loon, LJ; Rolland, Y; Orwoll, E; Reid, K; Boonen, S; Dere, W; Epstein, S; Mitlak, B; Tsouderos, Y; Sayer, AA; Rizzoli, R; Reginster, JY; Kanis, JA

2013-01-01

Summary This review provides a framework for development of an operational definition of sarcopenia and of the potential endpoints that might be adopted in clinical trials among older adults. Introduction While the clinical relevance of sarcopenia is widely recognized, there is currently no universally accepted definition of the disorder. The development of interventions to alter the natural history of sarcopenia also requires consensus on the most appropriate endpoints for determining outcomes of clinical importance which might be utilised in intervention studies. Methods and results We review current approaches to the definition of sarcopenia, and the methods used for the assessment of various aspects of physical function in older people. The potential endpoints of muscle mass, muscle strength, muscle power and muscle fatigue, as well as the relationships between them, are explored with reference to the availability and practicality of the available methods for measuring these endpoints in clinical trials. Conclusions Based on current evidence, none of the four potential outcomes in question is sufficiently comprehensive to recommend as a uniform single outcome in randomised clinical trials. We propose that sarcopenia may be optimally defined (for the purposes of clinical trial inclusion criteria, as well as epidemiological studies) using a combination of measures of muscle mass and physical performance. The choice of outcome measures for clinical trials in sarcopenia is more difficult; co-primary outcomes, tailored to the specific intervention in question, may be the best way forward in this difficult but clinically important area. PMID:23842964

Clinical Relevance of Informal Coercion in Psychiatric Treatment-A Systematic Review.

PubMed

Hotzy, Florian; Jaeger, Matthias

2016-01-01

Although informal coercion is frequently applied in psychiatry, its use is discussed controversially. This systematic review aimed to summarize literature on attitudes toward informal coercion, its prevalence, and clinical effects. A systematic search of PubMed, Embase, PsycINF, and Google Scholar was conducted. Publications were included if they reported original data describing patients' and clinicians' attitudes toward and prevalence rates or clinical effects of informal coercion. Twenty-one publications out of a total of 162 articles met the inclusion criteria. Most publications focused on leverage and inducements rather than persuasion and threat. Prevalence rates of informal coercion were 29-59%, comparable on different study sites and in different settings. The majority of mental health professionals as well as one-third to two-third of the psychiatric patients had positive attitudes, even if there was personal experience of informal coercion. We found no study evaluating the clinical effect of informal coercion in an experimental study design. Cultural and ethical aspects are associated with the attitudes and prevalence rates. The clinical effect of informal coercion remains unclear and further studies are needed to evaluate these interventions and the effect on therapeutic relationship and clinical outcome. It can be hypothesized that informal coercion may lead to better adherence and clinical outcome but also to strains in the therapeutic relationship. It is recommendable to establish structured education about informal coercion and sensitize mental health professionals for its potential for adverse effects in clinical routine practice.